Europaudvalget 2023
KOM (2023) 0783
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EUROPEAN
COMMISSION
Brussels, 7.12.2023
SWD(2023) 850 final
COMMISSION STAFF WORKING DOCUMENT
Accompanying the documents
Proposal for a Regulation of the European Parliament and of the Council amending
Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021
of the European Parliament and of the Council as regards the re-attribution of scientific
and technical tasks and improving cooperation among Union agencies in the area of
chemicals
and
Proposal for a Directive of the European Parliament and the Council amending
Directive 2011/65/EU of the European Parliament and of the Council as regards the re-
attribution of scientific and technical tasks to the European Chemicals Agency
{COM(2023) 783 final} - {COM(2023) 781 final}
EN
EN
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Table of contents
1.
INTRODUCTION: POLITICAL AND LEGAL CONTEX ………….…………………………………...……..3
1.1 Political context
..............................................................................................................3
1.2 Legal context
.................................................................................................................4
1.3 Scope of the document
......................................................................................................6
2.
3.
4.
5.
6.
7.
8.
9.
10.
PROBLEM DEFINITION .................................................................................................................................................. 7
OBJECTIVES: WHAT IS TO BE ACHIEVED? ............................................................................................................. 8
AVAILABLE OPTIONS .................................................................................................................................................... 8
STAKEHOLDER VIEWS................................................................................................................................................ 10
SCIENTIFIC AND TECHNICAL WORK ON CHEMICALS FOR (RE-)ATTRIBUTION TO THE EU
AGENCIES AND STRENGTHENING THE COOPERATION AMONG THE AGENCIES ................................. 11
ASSESSMENT OF IMPACTS ........................................................................................................................................ 19
IMPACTS OF THE LEGISLATIVE PROPOSALS ON REATTRIBUTION OF TASKS....................................... 20
IMPACT OF THE LEGISLATIVE PROPOSAL FOR A REGULATION ESTABLISHING A COMMON DATA
PLATFORM AND A MONITORING AND OUTLOOK FRAMEWORK FOR CHEMICALS ........................ …23
OVERALL IMPACTS FROM ALL (RE-)ATTRIBUTIONS ...................................................................................... 29
10.1 Added value and synergies of the (re-)attributions
.................................................................... 29
10.2 Overall impact on resources
............................................................................................. 30
10.3 Overall impacts on ECHA
................................................................................................ 34
10.4 Overall impacts on EEA
.................................................................................................. 36
10.5 Overall impacts on EFSA
................................................................................................. 37
10.6 Overall impacts on EMA
................................................................................................. 39
10.7 Overall impacts on EU-OSHA
........................................................................................... 41
ANNEX I: MISSION, CORE ACTIVITIES, COMPETENCES AND SCIENTIFIC BODIES OF THE AGENCIES .... 42
1.
2.
3.
4.
5.
EUROPEAN FOOD SAFETY AUTHORITY .......................................................................................................... ….42
EUROPEAN CHEMICALS AGENCY .......................................................................................................................... 44
EUROPEAN MEDICINES AGENCY............................................................................................................................ 46
EUROPEAN ENVIRONMENT AGENCY ................................................................................................................... 48
EUROPEAN AGENCY FOR SAFETY AND HEALTH AT WORK ........................................................................ 50
ANNEX II: SUMMARY OF THE FEEDBACK RECEIVED THROUGH THE PUBLIC CONSULTATION ON THE
CALL FOR EVIDENCE FOR THE INITIATIVE ON (RE-)ATTRIBUTION OF SCIENTIFIC AND TECHNICAL
WORK ON CHEMICALS TO THE EU AGENCIES................................................................................................... 52
1.
2.
3.
4.
5.
RESPONDENTS ............................................................................................................................................................... 52
TYPE OF RESPONSES ................................................................................................................................................... 52
SUPPORT TO THE INITIATIVE ON 1S1A ................................................................................................................. 52
SCOPE AND OBJECTIVES OF 1S1A........................................................................................................................... 54
REATTRIBUTION OF TASKS TO EU AGENCIES ................................................................................................... 57
ANNEX III: DETAILED IMPACT ANALYSIS OF THE (RE-)ATTRIBUTION OF SCIENTIFIC AND TECHNICAL
WORK RELATED TO CHEMICALS TO EU AGENCIES ........................................................................................ 60
1.
2.
3.
DRINKING WATER DIRECTIVE (2020/2184) ........................................................................................................... 60
REGULATION ON SERIOUS CROSS-BORDER THREATS TO HEALTH (2022/2371) .................................... 64
EUROPEAN PARTNERSHIP FOR THE ASSESSMENT OF RISKS FROM CHEMICALS (PARC) ................. 66
1
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4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33.
34.
35.
36.
COMMISSION IMPLEMENTING DECISION 2022/1979 UNDER SEVESO DIRECTIVE ................................. 69
BATTERIES REGULATION (PROPOSAL) ................................................................................................................ 76
E-PRTR REGULATION (2006/166) .............................................................................................................................. 81
INDUSTRIAL EMISSIONS DIRECTIVE (2010/75/EU)............................................................................................. 82
ENVIRONMENTAL QUALITY STANDARD DIRECTIVE (2008/105/EC) + WATER FRAMEWORK
DIRECTIVE (2000/60/EC) + GROUNDWATER DIRECTIVE (2006/118/EC) ....................................................... 85
CLP REGULATION (1272/2008) ................................................................................................................................... 96
PACKAGING AND PACKAGING WASTE DIRECTIVE ....................................................................................... 100
LEGISLATION ON MEDICINAL PRODUCTS FOR HUMAN USE (726/2004) ................................................. 101
END-OF LIFE VEHICLES (ELV) DIRECTIVE ......................................................................................................... 105
TOY SAFETY DIRECTIVE .......................................................................................................................................... 110
RESTRICTION OF HAZARDOUS SUBSTANCE (ROHS) DIRECTIVE (2011/65/EU) ..................................... 115
POPS REGULATION (2019/1021) ............................................................................................................................... 121
MEDICAL DEVICES REGULATION ........................................................................................................................ 129
EEA FOUNDING REGULATION (1210/90) .............................................................................................................. 134
GENERAL FOOD LAW (178/2002) ............................................................................................................................ 137
EU COMMON DATA PLATFORM ON CHEMICALS ........................................................................................... 139
INFORMATION PLATFORM FOR CHEMICAL MONITORING (IPCHEM) ..................................................... 148
INFORMATION ON REGULATORY PROCESSES ON CHEMICALS ............................................................... 155
REPOSITORY OF REFERENCE VALUES ............................................................................................................... 163
INFORMATION ON THE OBLIGATIONS UNDER UNION ACTS ON CHEMICALS .................................... 168
DATABASE ON ENVIRONMENTAL SUSTAINABILITY RELATED INFORMATION ................................ 171
MECHANISM FOR INITIATING TESTING AND MONITORING ...................................................................... 173
MECHANISM FOR NOTIFICATION OF STUDIES ................................................................................................ 176
EU CHEMICAL EARLY WARNING AND ACTION SYSTEM AND INDICATOR FRAMEWORK FOR
CHEMICALS................................................................................................................................................................... 179
OBSERVATORY FOR SPECIFIC CHEMICALS WITH POTENTIAL CONTRIBUTION TO EMERGING
CHEMICAL RISKS ........................................................................................................................................................ 184
COOPERATION OF ECHA WITH OTHER EU AGENCIES .................................................................................. 187
SCIENTIFIC OPINIONS ON OCCUPATIONAL EXPOSURE LIMITS ................................................................ 190
REACH REGULATION (1907/2006)........................................................................................................................... 192
COSMETIC PRODUCTS REGULATION .................................................................................................................. 196
SCIENTIFIC COMMITTEES AND THEIR SECRETARIAT (SCCS/SCHEER)................................................... 204
ECODESIGN FOR SUSTAINABLE PRODUCTS REGULATION ........................................................................ 212
TOBACCO PRODUCTS DIRECTIVE ........................................................................................................................ 213
REGULATION ON FLUORINATED GREENHOUSE GASES AND REGULATION ON OZONE DEPLETING
SUBSTANCES ................................................................................................................................................................ 214
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1.
I
NTRODUCTION
:
POLITICAL AND LEGAL CONTEXT
1.1
Political context
Chemicals are everywhere in our daily lives and play a fundamental role in most of our activities, as they form
part of virtually every device we use to ensure our well-being (be it for food, electronics, toys, clothes or
industrial machines), protect our health and security, and meet new challenges through innovation. The EU is
the second largest producer of chemicals in the world with EUR 541 billion turnover in 2018 (7.0% of EU
manufacturing by turnover) and 14.4% of global sales in 2020 (CEFIC, 2022)
1
and chemical manufacturing is
the fourth largest industry in the EU comprising 30 000 companies, 95% of which are SMEs, directly
employing approximately 1.2 million people and 3.6 million indirectly.
At the same time, chemicals can cause harm to human health and the environment. Certain chemicals cause
cancers, affect the immune, respiratory, endocrine, reproductive and cardiovascular systems and increase
vulnerability to diseases. Exposure to these harmful chemicals is therefore a threat to human health. In addition,
the pollution of environment with chemicals is one of the key drivers putting the Earth at risk
2
, impacting and
amplifying planetary crises such as climate change, degradation of ecosystems and loss of biodiversity,
examples being negative effects on pollinators, insects, aquatic ecosystems and bird population.
In order to ensure a high level of protection of human health and the environment from the adverse effects of
chemicals and to support the efficient functioning of the internal market for chemicals while promoting the
competitiveness and innovation of EU industry, the European Union has developed a comprehensive
regulatory framework for chemicals.
The framework has been developed progressively, with the first legislation coming in place as early as in 1967.
The framework consists currently of over 40 pieces of legislation, addressing: the
production and placing on
the market of chemicals and chemical products, such as
(e.g. industrial chemicals, biocidal products, plant
protection products, human and veterinary pharmaceuticals, cosmetic products, detergents),
emissions of
chemicals
(e.g. from industrial installations, waste water treatment plants or use of fertilisers), protection
of
workers’ health
(e.g. from carcinogens, mutagens and reprotoxic substances, from asbestos, or from chemical
agents in general),
chemicals in waste
(e.g. in general, in packaging and packaging waste or in end-of-life
vehicles),
safety of consumer products
(e.g. toys, food contact materials, batteries),
safety of foodstuff and
feedstuff
(e.g. food improvements agents or maximum residue levels of food contaminants ) and
protection
of the environmental compartments (e.g.
surface waters, ground waters, marine waters, drinking water, air
and soil).
The fitness check of the most relevant chemicals legislation assessing over 40 pieces of legislation concluded
that overall the EU chemicals legislation delivers results as intended and is fit-for-purpose, but a number of
significant weaknesses prevent the EU chemicals legislation from living up to its full potential. There were
identified shortcomings across legislative pieces as regards the coherence of safety assessments, efficiency of
the underlying technical and scientific work and the coherence of transparency rules. These shortcomings can
lead to inconsistency and incoherence in safety assessments, slow procedures, inefficient use of resources,
unnecessary burden, (perceived) lack of transparency and sometimes low quality of scientific advice (see
section 2).
Building on the findings of the fitness check, the
European Green Deal
announced the commitment ‘to
review
how to use better the EU’s agencies and scientific bodies to move towards a process of ‘one substance, one
assessment’ and to provide greater transparency when prioritising action to deal with chemicals’.
The
Chemicals Strategy for Sustainability
elaborated further on the concept of ‘one substance, one assessment’ and
defined it as an approach to improve the overall efficiency, coherence and transparency of the delivery of
safety assessments of chemicals across legislation. The strategy identified five key areas affecting the
coherence and efficiency of delivery of safety assessments and for each of them defined number of specific
1
Within the EU, two thirds of these sales are generated in four Member States: Germany (32.1%), France (13.5%), Italy (10.7%) and
the Netherlands (8.9%) (CEFIC, 2022). See Annex 18 for more information on the chemical sector in the EU.
2
Rockström, J. et al., Planetary Boundaries: Exploring the Safe Operating Space for Humanity. Ecology and Society,
2009
3
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objectives and actions (see sections 2 and 3). Two key actions identified are to ‘rationalise the use of expertise
and resources by
proposing the reattribution of technical and scientific work on chemicals performed
under the relevant pieces of legislation to European agencies,
including work of the Scientific Committee
on Health, Environmental and Emerging Risks (SCHEER) and Scientific Committee on Consumer Safety
(SCCS)’ and to ensure ‘a clear allocation of responsibilities and
good cooperation among the European
Agencies’.
The
EU Action Plan ‘Towards Zero Pollution for Air, Water and Soil’
further contributed to the one substance,
one assessment objectives through commitments to consolidate the roles of the European Environment Agency
and the Commission’s Joint Research Centre in close collaboration with the European Chemicals Agency, the
European Food Safety Agency, the European Maritime Safety Agency and other relevant agencies as the EU’s
Knowledge Centres of Excellence for Zero Pollution Monitoring and Outlook Framework.
The
European Parliament resolution
of 10 July 2020 welcomed the Strategy and the ‘one substance – one hazard
assessment’ principle in order to better use the resources of the Union’s agencies and scientific bodies, avoid
duplication of efforts, reduce the risk of diverging outcomes of assessments, speed up and bring consistency
and transparency to chemicals regulation, and ensure enhanced health and environmental protection and a level
playing field for industry. The resolution called to achieve coherence and synergies between legislation dealing
with chemicals and chemical products, specific products regulation, general product legislation, legislation on
environmental compartments, legislation on sources of pollution and legislation on waste. The resolution
further called to pay special attention to reducing overlaps between legal frameworks, and between tasks
allocated to the European Chemicals Agency, the European Food Safety Agency and the European Medicines
Agency. The resolution also underlined the need to reinforce cooperation and coordination between the
European evaluation agencies EFSA and ECHA together with national agencies, by developing common
guidelines for risk assessment, namely for biocidal and phytopharmaceutical products, which take into account
the most recent scientific results, so as to avoid inconsistencies. Finally, the European Parliament called on the
Commission and Council to refrain from cutting ECHA’s resources in annual budget procedures and to provide
ECHA with additional resources for any other tasks that may be required, such as conducting evaluations of
substances.
The
Council conclusions
of 15 March 2021 also welcomed the Strategy and the ‘one substance, one assessment’
approach intending to simplify and improve the transparency of the regulatory framework for hazard and risk
assessment of chemicals, to enhance coherence, to better coordinate the EU rules on chemicals, and to make
decision-making faster. The conclusions called to continue ensuring policy coherence and exploit synergies
among the chemicals and other policies. The conclusion further emphasised that the one substance, one
assessment approach should not create delays in regulatory actions nor increase administrative burden, that the
Member States are closely involved in the development of the approach and that the right of initiative of the
Member States to initiate regulatory action is maintained. The conclusions also underlined the importance of
allocating the necessary resources for the European agencies in the light of the envisaged re-attribution of
technical and scientific work on chemicals, including an appropriate and long-term budgetary framework, and,
in particular, for ECHA, taking into consideration their central role in the implementation of some key
objectives of the Chemicals Strategy.
1.2
Legal context
The reattribution of existing tasks or attribution of new tasks to EU Agencies requires targeted amendments of
the existing pieces of legislation on chemicals. The preferred way of doing it is by introducing changes in
allocation of tasks when the individual pieces of legislation are being revised. Therefore, the relevant changes
have been already proposed as part of the proposals for the regulation on serious cross-border threats to health
3
3
Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-
border threats to health and repealing Decision No 1082/2013/EU (OJ L 314 6.12.2022, p. 26).
4
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and for revisions of drinking water directive
4
, SEVESO III directive
5
, batteries regulation
6
, EPRTR regulation
7
,
industrial emissions directive
8
, water framework directive, ground water directive, environmental quality
standard directive
9
, CLP regulation
10
, packaging and packaging waste directive
11
, legislation on medicinal
products for human use
12,13
, end-of-life vehicles directive
14
and directive on the safety of toys
15
. The relevant
changes, including new or additional tasks, are also planned to be introduced in the upcoming proposals for a
regulation on ECHA
16
and for the revisions of REACH
17
and cosmetics regulation
18
.
Where the chemical legislation is not to be opened within this mandate of the Commission, the necessary
changes in allocation of tasks is introduced through the horizontal proposals on reattribution of tasks to the
EU Agencies consisting of a regulation and a directive, for reasons of legal consistency. The proposal for the
regulation proposes targeted amendments to allocations of tasks in the POPs regulation
19
, medical devices
4
Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of
water intended for human consumption (OJ L 435 23.12.2020, p. 1).
5
Commission Implementing Decision (EU) 2022/1979 of 31 August 2022 on establishing the form and databases for
communicating the information referred to in Articles 18(1) and 21(3) of Directive 2012/18/EU of the European
Parliament and of the Council on the control of major-accident hazards involving dangerous substances and repealing
Commission Implementing Decision 2014/895/EU (OJ L 272 20.10.2022, p. 14).
6
Regulation (EU) 2023/1542 of the European Parliament and of the Council of 12 July 2023 concerning batteries and
waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and repealing Directive 2006/66/EC
(OJ L 191, 28.7.2023, p.1).
7
Proposal for a Regulation of the European Parliament and of the Council on reporting of environmental data from
industrial installations and establishing an Industrial Emissions Portal (COM/2022/157 final).
8
Proposal for a Directive of the European Parliament and of the Council amending Directive 2010/75/EU of the
European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention
and control) and Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste (COM (2022) 156 final).
9
Proposal for a Directive of the European Parliament and of the Council amending Directive 2000/60/EC establishing a
framework for Community action in the field of water policy, Directive 2006/118/EC on the protection of groundwater
against pollution and deterioration and Directive 2008/105/EC on environmental quality standards in the field of water
policy (COM(2022) 540 final).
10
Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 1272/2008 of
the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures
(COM (2022) 748 final).
11
Proposal for a regulation of the European Parliament and of the Council on packaging and packaging waste,
amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC (COM(2022)
677 final).
12
Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal
products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC (COM (2023) 192 final).
13
Proposal for a Regulation of the European Parliament and of the Council laying down Union procedures for the
authorisation and supervision of medicinal products for human use and establishing rules governing the European
Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing
Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 (COM (2023) 193
final).
14
Proposal for a Regulation of the European Parliament and of the Council on circularity requirements for vehicle
design and on management of end-of-life vehicles, amending Regulation (EU) 2018/858 and 2019/1020 and repealing
Directives 2000/53/EC and 2005/64/EC (COM (2023) 451 final).
15
Proposal for a Regulation of the European Parliament and of the Council on the safety of toys and repealing Directive
2009/48/EC (COM(2023) 462 final).
16
European Chemicals Agency – proposal for a basic regulation (europa.eu)
17
Chemicals legislation – revision of REACH Regulation to help achieve a toxic-free environment (europa.eu)
18
EU chemicals strategy for sustainability – Cosmetic Products Regulation (revision) (europa.eu)
19
Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic
pollutants (OJ L 169 25.6.2019, p. 45)
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regulation
20
, EEA founding regulation
21
and the general food law
22
, while the proposal for a directive proposes
targeted amendments to allocations of tasks in the RoHS directive
23
.
The Proposal for a Regulation of the European Parliament and of the Council establishing a common data
platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible,
interoperable and reusable and establishing a monitoring and outlook framework for chemicals is a standalone
regulation aiming to implement one substance, one assessment actions related to data, information and
transparency, namely:
•
•
•
•
•
•
•
•
use a single ‘Public activities coordination tool’ to provide an up-to-date overview of all planned and
ongoing initiatives on chemicals by authorities across legislation;
develop a common open data platform on chemicals to facilitate the sharing, access and re-use of
information on chemicals coming from all sources;
promote reuse and harmonisation of human and environmental health-based limit values among EU
risk assessors and managers through a centralised and curated EU repository;
remove legislative obstacles for the re-use of data and better streamline the flow of chemical data
between EU and national authorities;
establish tools and practices to ensure that relevant academic data is easily and readily accessible for
safety assessments and is suitable for regulatory purposes;
enable EU authorities to commission testing and monitoring of substances as part of the regulatory
framework when further information is considered necessary;
extend the principle of open data and the relevant transparency principles from the EU food safety
sector to other pieces of chemical legislation;
develop an EU early warning and action system for chemicals to ensure that EU policies address
emerging chemical risks as soon as identified by monitoring and research.
In order to implement these actions, the proposal also allocates some new tasks to EU agencies as regards the
management, sharing and generation of data and information, operation of a monitoring and outlook
framework for chemicals and formalises some existing tasks.
1.3
Scope of the document
This document summarises all actions taken as of 2020 to (re-)attribute scientific and technical work on
chemicals to EU agencies and to ensure good cooperation among the EU agencies in the area of chemicals.
The document accompanies the horizontal legislative proposals on reattribution of tasks to EU agencies, and
explains changes in (re-)attributions proposed in those proposals. It also explains, for the purpose of
completeness of information changes which will be made to allocation of tasks via revisions of individual
pieces of legislation or via a new legislation, including via the proposal for a Regulation on establishing a
common data platform on chemicals, laying down rules to ensure that the data contained in it are findable,
accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals
(‘proposal for a regulation establishing a common data platform and a monitoring and outlook framework for
chemicals’). The document explains how the changes in allocation of tasks to EU agencies contribute to
achieving the one substance, one assessment objectives and provides an assessment of cumulative impacts of
the changes in allocations of tasks on the functioning of the EU Agencies.
20
Regulation (EU) of the European Parliament and of the Council of 5 April 2017 on medical devices, amending
Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council
Directives 90/385/EEC and 93/42/EEC (OJ L 117 5.5.2017, p.1)
21
Regulation (EC) No 401/2009 of the European Parliament and of the Council of 23 April 2009 on the European
Environment Agency and the European Information and Observation Network (OJ L 126 21.5.2009, p.13)
22
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the
general principles and requirements of food law, establishing the European Food Safety Authority and laying down
procedures in matters of food safety (OJ L 031 1.2.2002, p.1)
23
Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of
certain hazardous substances in electrical and electronic equipment (OJ L 174 1.7.2011, p.88)
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2.
P
ROBLEM DEFINITION
The EU regulatory framework for hazard and risk assessment and management of chemicals is comprehensive.
It consists of many pieces of legislation, addressing production and placing on the market of chemicals and
chemical products, emissions of chemicals, chemicals in waste, protection of workers’ health and safety of
consumer products, foodstuff and feedstuff, and the environment. A high volume of technical and scientific
work supports the implementation of the individual legislative acts. Depending on the legislation, the work is
performed using different data and methodologies and involving various EU Agencies (the European
Chemicals Agency (ECHA), the European Food Safety Authority (EFSA), the European Environment Agency
(EEA), the European Medicine Agency (EMA) and the European Agency for Safety and Health at Work (EU-
OSHA)), scientific committees, (ad hoc) expert groups, Commission services or external contractors. This
situation may lead to inconsistent and incoherent outcomes of assessments across legislation (in respect of the
same chemicals), inefficient use of resources and unnecessary costs (from operating several committees
performing similar assessments, from assessing the same chemical by several committees/bodies or from
duplicating supporting technical and scientific work). In addition, the assessments that are not performed by
the EU Agencies are often being criticised by the stakeholders as not sufficiently transparent and inclusive,
having insufficient scientific quality and robustness or having insufficient separation between risk assessment
and risk management.
The key drivers that one substance, one
assessment approach intends to address are:
•
Assessments are initiated under various
pieces of legislation, by various actors
and at different points in time;
•
Assessments are performed by various
agencies, scientific committees, expert
groups or external consultants;
•
Assessments are using various data and
they varies in their availability,
accessibility, quality and are stored in
different formats;
•
Assessments
are
using
various
methodologies and guidance documents;
•
Various transparency rules and practices
are applied.
The key problems arising from these drivers that the legislative proposals on (re-)attribution of tasks to EU
Agencies aim to address are:
•
•
•
•
multiple actors performing scientific and technical work;
varying degree of scientific robustness and procedural rigour of the actors performing scientific and
technical work;
incoherent methodologies and guidance documents;
insufficient cooperation and coordination among the actors performing scientific and technical work
on chemicals.
The other problems arising from these drivers are being addressed as part of other ‘one substance, one
assessment’ legislative as well as non-legislative actions. For example, the problems related to complicated
accessibility and availability of data underlying the assessments are being addressed by the proposal for a
Regulation on establishing a common data platform on chemicals, laying down rules to ensure that the data
contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook
framework for chemicals.
The problems have evolved as a consequence of the progressive development of the EU legislative framework
for chemicals over the last 55 years and without this intervention, it will continue to persist.
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3.
O
BJECTIVES
: W
HAT IS TO BE ACHIEVED
?
The general objective of one substance, one assessment approach and of this initiative is to ensure coherent,
efficient and transparent delivery of safety assessments of chemicals across EU chemical legislation and thus
contribute to a well-functioning single market for chemicals and a high level of protection of human health
and the environment from chemicals.
The specific objectives of the one substance, one
assessment approach are:
•
Initiation or triggering of the assessments is to
the extent possible synchronised and
coordinated and substances are assessed in
groups rather than substance-by-substance
•
Responsibilities for performing the assessment
are clear and allocated to make the best use of
available expertise and resources and there is a
good cooperation among all players
•
Assessments have access to all available data
without technical and administrative burden
•
Methodologies used are coherent and to the
extent possible harmonised
•
There is a high level of transparency in
performing assessments as well as in the
underlying scientific data and information
The specific objectives of the legislative proposals on (re-)attribution of tasks to EU Agencies are one step to
achieve the one substance, one assessment approach. They are to ensure that:
•
•
allocation of responsibilities for performing the assessments and the underlying technical and scientific
work on chemicals is clear, exploits and maximises synergies and makes the best use of available
expertise and resources;
there is a good cooperation among all players on all aspects underling the assessment of chemicals
(such as methodology development and exchange of data);
the deliverables are of high scientific quality and the procedures are transparent and inclusive.
•
4.
A
VAILABLE OPTIONS
Considering the problem drivers and the specific objectives to be achieved, there is very little discretion on the
main policy choices. The
preferred option
is clearly to
consolidate the technical and scientific work on
chemicals performed under the relevant pieces of EU legislation in the EU Agencies
and to
strengthen
the cooperation among the EU Agencies
as regards technical and scientific work on chemicals. The EU
agencies have been founded as independent bodies with adequate funding, they maintain the necessary
expertise, provide robust and high quality scientific work and follow transparent and inclusive procedures.
Any other possible option (e.g. consolidation of work at other actors than EU Agencies or bringing all the
existing actors at the same level of scientific robustness and procedural transparency and ensuring cooperation
among them) would be less efficient, more expensive and provide less benefits.
While the main policy option is clear and straightforward, there are sub-options as regards which tasks are
suitable and useful to be reattributed to EU Agencies, which EU agency the (re-)attributed tasks should be
assigned to and how and in which areas to strengthen the cooperation among the EU Agencies.
Guiding principles for (re-)attribution of scientific and technical work to EU Agencies
The following guiding principles were developed and followed to identify tasks for (re-)attribution to EU
Agencies and to decide as to which EU Agency the task should be assigned:
1. The ‘technical
and scientific work on chemicals’ is considered in a broad sense
and includes:
8
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•
•
•
•
•
•
•
•
•
assessments of risk from, hazard of and exposure to chemicals;
monitoring of occurrence and emissions of chemicals;
determination of safe levels of chemicals for ecosystems and for humans;
development of guidance documents;
managing scientific committees, expert groups and network of experts;
collecting, analysing and hosting data and information on chemicals and associated processes;
hosting and operating (public) information platforms on chemicals;
managing the data flows on chemicals and defining data formats; and
assessments of socio-economic consequences/impacts of risk management measures on
chemicals.
2. The existing technical and scientific work on chemicals performed at EU level under, or in support of,
all relevant EU legislation is considered.
No legislation is a priory excluded.
3.
Consider
attributing the scientific and technical work related to safety assessment of chemicals to one
of the EU Agencies with a mandate related to chemicals,
i.e.
the European Chemicals Agency
(ECHA), the European Food Safety Authority (EFSA), the European Medicine Agency (EMA), the
European Environment Agency (EEA) or the European Agency for Safety and Health at Work (EU-
OSHA);
4.
Ensure fit with the core focus
of the EU Agencies’ work on chemicals, in terms of use of substance
in specific products, the route of exposure assessed, the type of sectors covered and mission of the
agency.
5.
Maximize synergies and coherence
with ongoing activities, by attributing new activities on the basis
of similarity with:
•
Substances, data and data flows currently managed by the Agency;
•
Existing expertise and competence;
•
Output being provided by the Agency;
•
Existing processes and procedures implemented by the Agency;
•
Methodologies developed and applied by the Agency;
•
Existing IT tools and planned developments;
•
Networks of experts or committees governed or managed by the Agency.
6. Strive that the (re-)attribution of tasks brings synergies and benefits to the Union beyond a mere shift
of responsibilities.
Solutions to strengthen the cooperation among the EU Agencies
The following solutions were identified for strengthening the cooperation among the EU Agencies:
1. All agencies have equal legal obligations to cooperate with other agencies. The areas to be covered are
those identified under the one substance, one assessment as affecting the coherence and efficiency of the
assessments of chemicals, such as
- development of methodologies,
- development of formats and controlled vocabularies,
- exchange of data and information related to chemicals and their assessment.
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2. All agencies have a clear and equal mandate to develop methodologies for assessments related to chemicals
in the fields falling within their mandate and to set formats and controlled vocabularies for data and
information they hold.
3. All agencies performing the assessment of chemicals should have an obligation to cooperate to prevent the
divergent opinions and if divergent opinions appear, they should cooperate to solve it. A procedure for
solving the divergent opinions should be specified.
The best results in terms of strengthening the cooperation among the EU Agencies and enabling coherence of
scientific and technical work provided by the EU Agencies is achieved by implementing all three solutions.
Requiring cooperation among the agencies on certain areas without providing a clear mandate for those areas
would not achieve the desired objective. Providing a mandate to an agency for certain areas and not obliging
the cooperation among agencies might lead to even more divergence.
5.
S
TAKEHOLDER VIEWS
A call for evidence for the initiative on making best use of EU agencies to streamline scientific assessments
was published on the Commission website ‘Have
your say’
on 15 March 2022. The public and stakeholders
were invited to provide feedback on this initiative until 12 April 2022. In total, 65 submissions were received.
Most were from business associations and companies (in total around 70% of submissions), followed by
submissions from EU citizens (11%), non-governmental organisations (6%), public authorities (6%), others (5
%) and academic/research institutions (1.5%). Generally, there was a large support of the initiative among the
respondents, whether of the ‘one substance, one assessment’ approach as a whole or of the specific initiative
on the reattribution of tasks. 67% of respondents expressed their explicit support, 23% did not expressed
explicitly their opinion but provided relevant advices on how to develop the one substance, one assessment
approach. About 10% expressed doubts about usefulness of the initiative or opposition to the initiative.
As the call for evidence was the first public consultation on an initiative under the one substance, one
assessment, a lot of feedback received was not specific about the consulted initiative on the (re-)attribution of
task to the EU Agencies but about the general scope of the one substance, one assessment approach as well as
other initiatives announced under the one substance, one assessment.
Annex II
provides a summary of all the
feedback received.
Stakeholders were also informed and consulted on the reattribution of tasks to EU agencies during the
Information Session on One Substance, One Assessment with Stakeholders held on 1 June 2022. Some 800
participants followed this on-line event.
An extensive discussion on re-attribution of tasks to EU agencies was held with representatives of Member
States and EU agencies at the meetings of the Expert Group on One Substance, One Assessment
7
held on 2-3
June 2022 and on 30 March 2023.
Representatives of Member States and EU agencies participating in the expert group meetings were supportive
to the initiative as well, providing concrete suggestions on the reattributions.
The feedback regarding the (re-)attribution of tasks to the EU agencies received from the call for evidence and
from Member States and EU agencies during meetings of the Expert Group on One Substance, One Assessment
can be grouped in 6 areas and summarised as follows:
•
Level of centralisation:
Stakeholders and Member States suggested that re-attribution of work should not
result in a single agency being responsible for the risk evaluations of all chemicals. The regulations must
clearly set out the responsibilities of each agency.
Expertise:
Stakeholders suggested that reattributing tasks should be done based on the existing expertise
available in the agencies to ensure that the agency receiving the task benefits from the necessary expertise.
It should be ensured that valuable expertise acquired by existing bodies is preserved. Expertise in risk
assessment under the different regulations should stay with those agencies currently responsible for them.
Each Agency is best positioned to lead and carry out specific assessments because of their extensive
experience in product-specific matters, e.g., EFSA for food use and EMA for medicines use.
Resources:
Member States insisted that the new tasks for the agencies must be accompanied by the
required resources. Re-attributing work should not lead to an agency or a committee being unable to
manage the workload and jeopardise the quality of the work.
10
•
•
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•
Organisation of scientific committees:
Member State indicated that the agencies’ committees, especially
of ECHA, might need to be reorganised to deal with increased workload, as the committee for risk
assessment of ECHA has already now a high workload. Instead of creating new scientific panels or
committees, the agencies should preferably reinforce and reuse the existing panels, committees and
expert/working groups. In any event, safety assessments should be performed by an independent panel,
independent committee or expert group that is independent.
Tasks to re-attribute:
Some stakeholders and Member States suggested that the ECHA should be involved
in hazard assessment as part of the assessment of food contact materials, and EFSA should be involved in
risk assessments. The agencies should be involved in evaluating cosmetic ingredients, deriving
environmental quality standards under the Water Framework Directive, and in opinions on chemical
substances in products (for example in toys).
Impact assessment:
A few respondents from stakeholders suggested to carry out an impact assessment on
the one substance, one assessment initiative to ensure that possible impacts on businesses are considered
sufficiently and that businesses are involved in developing the initiative.
•
•
6.
S
CIENTIFIC
AND TECHNICAL WORK ON CHEMICALS FOR
(
RE
-)
ATTRIBUTION TO THE
AGENCIES AND STRENGTHENING THE COOPERATION AMONG THE
A
GENCIES
EU
Scientific and technical work on chemicals for (re-)attribution to the EU Agencies have been identified under
36 pieces of legislation or work packages (see Table 1 below). The tasks for (re-)attribution have been
identified through the targeted inter-service consultation including the EU Agencies, targeted consultation with
Member States and targeted consultation with stakeholders and by applying the guiding principles for the (re-
)attribution of scientific and technical work on chemicals to the EU Agencies (see section 4). The way how
the tasks are (re-)attributed to the EU Agencies was discussed at length between the concerned Commission
Service and the receiving Agency, taking into account the policy objectives, desired scientific rigour, scrutiny
and technical and organisational feasibility. A particular attention was paid to the assessment of the proximity
of a task for (re-)attribution with the Agency’s mandate and to the identification of potential synergies and
added value of the (re-)attribution.
There are various types of task (re-)attributions that have been proposed or are being considered (see ‘task
type’ in Table 1). Reattribution of existing tasks from a non-agency body to the EU Agencies have been
proposed or are being considered to be proposed under 12 pieces of legislation or work packages. Out of these
12 pieces of legislation or work packages, 3 contains reattributions that are accompanied with improvement or
expansion of the reattributed tasks while 9 contains reattributions of tasks without their expansion. Attributions
under 8 pieces of legislation or work packages are formalisation of the existing attributions of a task to an
agency without a legal basis or are improvements of the specification of existing tasks. Attributions under 17
pieces of legislation or work packages contain tasks that are new. Either they are extension of the tasks that
already exists at the agencies or they are completely new tasks.
The changes in the founding provisions of ECHA, EEA, EFSA and EMA to strengthen the cooperation among
the agencies are listed here as a (re-)attribution, or improvement of the specification of existing tasks, under
the respective founding regulations.
The (re-)attribution of tasks have been already adopted for 5 pieces of legislation / work packages, and it was
proposed for another 8 pieces of legislation. The (re-)attributions are still to be proposed for 20 pieces of
legislation/work packages and for 3 pieces of legislation the tasks are being defined and some of them might
be suitable for attribution to the EU Agencies, but it is premature to conclude on this.
Following the guiding principles, the highest number of tasks is to be (re-)attributed to ECHA, followed by
EEA, EFSA, EMA and EU-OSHA.
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Table 1.
Overview of legislation and work packages with tasks for (re-)attribution to the EU agencies
Legislation/work packages with tasks for (re-)attribution
Receiving body
Already adopted by the co-legislators
1
Drinking water directive
ECHA
2
Regulation on serious cross-border threats to health
ECHA, EEA, EFSA, EMA
3
European Partnership for the Assessment of Risks from Chemicals
ECHA, EEA, EFSA
Commission implementing decision 2022/1979 under SEVESO
4
EEA
directive
5
Batteries regulation
ECHA
Already proposed by the Commission
6
E-PRTR regulation
EEA
7
Industrial emissions directive
ECHA
8
Water legislation (surface and ground water)
ECHA, EEA
9
CLP regulation
ECHA,
EFSA
10 Packaging and packaging waste directive
ECHA
11 Legislation on medicinal products for human use
EMA
12 Directive on end-of-life vehicles
ECHA
13 Toys safety directive
ECHA
Proposed by the Commission as part of the package on one substance, one assessment
Proposal for a directive for reattribution of tasks
14
RoHS directive
ECHA
Proposal for a regulation for reattribution of tasks
15
POPs regulation
ECHA, EEA
16
Medical devices regulation
ECHA
17
EEA founding regulation
EEA
18
General Food Law
EFSA
Proposal for a regulation establishing a common data platform and a
monitoring and outlook framework for chemicals
19
Common Data Platform on Chemicals
ECHA, EEA, EFSA, EMA, OSHA
20
Information Platform for Chemical Monitoring
ECHA, EEA, EFSA, EMA, OSHA
Information on regulatory processes on chemicals
21
ECHA, EEA, EFSA,
OSHA
Repository of reference values
22
ECHA, EEA, EFSA, EMA, OSHA
Information on the obligations under Union acts on chemicals
23
ECHA
Environmental sustainability related data on chemicals
24
ECHA, EEA, EFSA, EMA, OSHA
ECHA,
EFSA
25
Data generation mechanism
Mechanism for notification of studies & database for study ECHA,
26
EFSA
notifications
Early warning and action system for emerging chemical risks and ECHA, EEA, EFSA, EMA, OSHA
27
framework of indicators
Observatory for specific chemicals with potential contribution to ECHA
28
emerging chemical risks
Planned to be proposed by the Commission
Legislative proposal for a regulation on ECHA
29
Cooperation of ECHA with other EU agencies
ECHA
30
Scientific opinions on occupational exposure limits
ECHA
31 REACH regulation
ECHA
32 Cosmetic products regulation
ECHA
33 Scientific advice of SCHEER on non-chemical topics
SAM
Tasks attribution considered
34 Sustainable product regulation
-
35 Tobacco products directive
-
36 Regulation on fluorinated greenhouse gases and Regulation on ozone -
depleting substances
Task type
N
RE
N
RE
N
REwE
FE, EwE
RE,N,EwE
N, EwE
EwE
FE
RE
RE
REwE
REwE
RE
FE
FE
N
RE, FE
EwE
N
EwE
N
N
N
N, EwE
FE, EwE
FE
FE
EwE
RE
RE
N
N
N
Legend: Colours are used to distinguish the legislative initiatives; N – attribution of a new task, EwE – existing task expanded; FE –
formalisation of attribution of an existing task or better specification of an existing task, RE – reattribution of an existing task, REwE
– reattribution of existing task and its expansion or improvement;
A brief description of the tasks and work for (re-)attribution per legislation or work package, including the
strengthening the provisions for cooperation among the EU Agencies, is provided below (for detailed
description see Annex III):
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1.
Drinking water directive
24
Revision of the drinking water directive in 2020 attributed
new tasks
to
ECHA.
ECHA is responsible for
establishing and maintaining four EU positive lists for substances and compositions authorized to be used for
the manufacturing of organic, cementitious, metallic and inorganic materials in contact with water intended
for human consumption. ECHA first supports the Commission in compiling the first EU positive lists based
on the national lists. Once established, ECHA will maintain the lists through the review of all the entries in the
lists and then through the addition, removal and updating of the entries.
2.
Regulation on serious cross-border threats to health
25
The new regulation on serious cross-border threats to health
reattributed an existing task
performed by the
Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) to
ECHA, EEA, EFSA,
EMA
and also to the European Centre for Disease Prevention and Control and the European Monitoring Centre
for Drugs and Drug Addiction. The regulation requires the agencies, on the request of the Commission, to
carry out a risk assessment of the potential severity of the threat to public health, including possible public
health measures when there is an alert of a cross-border threat of chemical origin. The responsibility for rapid
risk assessment for risks of a cross-border threat that is linked to medicinal products and medical devices is
assigned to the EMA, for risks of a cross-border threat of chemical origin is shared between the ECHA and the
EFSA based on their mandate and for risk of a cross border threat of threats of environmental origin, including
those due to the climate, are shared among the ECHA, the EFSA and the EEA based on their mandate. The
agencies will have to set up and maintain a continuous readiness to provide rapid risk assessments and on the
request provide the requested risk assessment.
3. European Partnership for the Assessment of Risks from Chemicals (PARC)
26
PARC is a 7-year partnership funded by Horizon Europe that started in May 2022 and aims to advance
research, share knowledge and improve skills in chemical risk assessment.
ECHA, EEA
and
EFSA
took a
new task
to provide input and support to the project in order to ensure maximum links with and benefits for
the regulatory risk assessments of chemicals.
4. Commission implementing decision (EU) 2022/1979 under the SEVESO Directive
27
The commission implementing decision
reattributed an existing task
performed by the Commission (DG
JRC) to
EEA.
EEA is tasked to redevelop and maintain the databases and associated procedures for the
reporting of information on industrial major accidents (eMARS) and for reporting of the location of Seveso
establishments (eSPIRS) under the SEVESO III directive.
5. Batteries regulation
28
The new regulation on batteries revising an old battery directive attributed a
new task
to
ECHA.
ECHA is
tasked to prepare, on the request of the Commission, restriction dossiers for substances in batteries, to get
opinions on them from the Committee for Risk Assessment and from the Committee on Socio-Economic
Analysis and to submit the opinions to the Commission for potential restrictions via a delegated act.
24
Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of
water intended for human consumption (OJ L 435 23.12.2020, p. 1).
25
Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-
border threats to health and repealing Decision No 1082/2013/EU (OJ L 314 6.12.2022, p. 26).
26
https://www.eu-parc.eu
27
Commission Implementing Decision (EU) 2022/1979 of 31 August 2022 on establishing the form and databases for
communicating the information referred to in Articles 18(1) and 21(3) of Directive 2012/18/EU of the European
Parliament and of the Council on the control of major-accident hazards involving dangerous substances and repealing
Commission Implementing Decision 2014/895/EU (OJ L 272 20.10.2022, p. 14).
28
Regulation (EU) 2023/1542 of the European Parliament and of the Council of 12 July 2023 concerning batteries and
waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and repealing Directive 2006/66/EC
(OJ L 191, 28.7.2023, p.1).
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6. E-PRTR regulation
29
The proposal for revision of the E-PRTR regulation proposes to
expand the existing task
of
EEA
to operate
the European Pollutant Release and Transfer Register. EEA is tasked to operate an Industrial Emission Portal,
which should replace the E-PRTR register and as compared to the E-PRTR should contain information on
emissions for more substances and for more industrial activities and should contain also information on the
use of water, energy and raw materials.
7. Industrial emissions directive
30
The proposal for the revision of the Industrial Emissions Directive proposes to
formalise existing task
of
ECHA
performed at ad-hoc basis and
extend it
to cover holistic consideration of chemicals in the permits of
the industrial emissions directive installations, from their presence in the (primary or secondary) raw materials
to their presence in the emissions from the installations, as well as in the waste and by-products generated.
ECHA is requested to support the Commission in the review of the Best Available Techniques Reference
(BREF) documents as regards the chemicals and industrial chemicals processes.
8. Water framework directive, Environmental Quality Standard Directive and Ground Water Directive
31
The proposal for the revision of the water framework directive, the environmental quality standard directive
and the ground water directive proposes to
reattribute existing tasks
performed by the Commission and the
Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) to
ECHA, attribute a new
task
to
ECHA
and
expand the existing tasks
performed by
EEA.
ECHA and its Committee for Risk
Assessment are requested under the Environmental Quality Standard directive to take over performing
assessments underpinning the amendment of priority list of substances, derivation of Environmental Quality
Standards, amendment of the ‘watch list’ and coordination of the ‘watch list’ activities. ECHA and its
Committee for Risk Assessment are requested under the Ground Water Directive to perform new assessments
underpinning the review of Annexes I and II with limit values for chemicals in ground water, the amendment
of ‘watch list’ and coordination of the ‘watch list’ activities. EEA is requested to expand its task on collection
of monitoring data in surface waters and to harvest all chemical monitoring data in waters generated by
Member States.
9. CLP Regulation
32
The proposal for revision of the CLP regulation proposes to attribute a
new task
to
ECHA
and
EFSA
and
expand the existing tasks
of
ECHA.
ECHA and EFSA are required to prepare, on the request of the
Commission, dossiers for harmonised classification of substances. ECHA’s Committee for Risk Assessment
is then expected to prepare opinions on the dossiers prepared by ECHA or EFSA, which will be submitted to
the Commission for potential amendment of Annex VI of CLP.
10. Packaging and packaging waste directive
33
29
Proposal for a Regulation of the European Parliament and of the Council on reporting of environmental data from
industrial installations and establishing an Industrial Emissions Portal (COM/2022/157 final).
30
Proposal for a Directive of the European Parliament and of the Council amending Directive 2010/75/EU of the
European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention
and control) and Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste (COM (2022) 156 final).
31
Proposal for a Directive of the European Parliament and of the Council amending Directive 2000/60/EC establishing
a framework for Community action in the field of water policy, Directive 2006/118/EC on the protection of
groundwater against pollution and deterioration and Directive 2008/105/EC on environmental quality standards in the
field of water policy (COM(2022) 540 final)
32
Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 1272/2008 of
the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures
(COM (2022) 748 final).
33
Proposal for a regulation of the European Parliament and of the Council on packaging and packaging waste,
amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC (COM(2022)
677 final).
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The proposal for revision of the packaging and packaging waste proposes to
extend the scope of task
of
ECHA
to process or eventually also to prepare a proposal for restriction under REACH that covers or is
focused on a presence of a substance in packaging. Such restriction will be under the scope of REACH, so this
relies on the existing REACH task.
11. Legislation on medicinal products for human use
34,35
The proposal for revision of the regulation and directive on medicinal products for human use proposes to
introduce a
new task
and
better specify existing tasks
of
EMA.
EMA is required to actively cooperate with
other EU Agencies as regards exchange of data, methodologies and scientific assessments. EMA is further
required to engage more in preventing or solving a divergent opinion with other EU Agencies. The goal is to
ensure coherence, consistency and interoperability in the specified areas. EMA is also expected to receive
marketing authorisation applications, like any other applications submitted to EMA, in electronic form and
follow the digital by default principle. In addition, EMA is requested to set up an active substance based
monograph system from environmental risk assessments.
12. Directive on end-of-life vehicles
36
The proposal for the revision of the directive on end-of-life vehicles proposes
reattribution of an existing
task
to
ECHA.
ECHA’s Committee for Socio-Economic Assessment will be required to provide assessments
underpinning review of exemption from existing restriction on lead, mercury, cadmium or hexavalent
chromium. ECHA is also required as part of REACH process to provide assessments underpinning restriction
of hazardous substances in end-of-life vehicles. Such restriction will be under the scope of REACH, so this
relies on the existing REACH task.
13. Toy safety directive
37
The proposal for the revision of the toy safety directive proposes
reattribution of existing tasks
to
ECHA
and
extending
some of them. ECHA’s committees for risk assessment and socio-economic analysis is required
to provide assessments underpinning the establishment or strengthening of chemical limit values in toys, the
amendment of the limit values for heavy metals in toys, the amendments to the lists of allergenic fragrances
that are prohibited in toys or that have to be labelled if present in toys and the granting of derogations for the
use of carcinogenic, mutagenic and reprotoxic substances in toys.
14. Directive on restriction of hazardous substances (RoHS) in electrical and electronic equipment
The proposal for amendment of the RoHS directive adopted as part the one substance, one assessment package
proposes to
reattribute the existing tasks
performed by the Commission to
ECHA
and
improve how those
tasks are executed.
ECHA is required to prepare, on the request of the Commission, a restriction dossier for
substances in electrical and electronic equipment. Such dossier can be also prepared by a Member State.
ECHA’s Committees for Risk Assessment and for Socio-Economic Analysis are then requested to prepare an
opinion on the restriction dossier (prepared by itself or by a Member State) and submit such opinions to the
Commission. ECHA is also requested to receive applications for granting, renewing or revoking an exemption
34
Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal
products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC (COM (2023) 192 final).
35
Proposal for a Regulation of the European Parliament and of the Council laying down Union procedures for the
authorisation and supervision of medicinal products for human use and establishing rules governing the European
Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing
Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 (COM (2023) 193
final).
36
Proposal for a Regulation of the European Parliament and of the Council on circularity requirements for vehicle
design and on management of end-of-life vehicles, amending Regulation (EU) 2018/858 and 2019/1020 and repealing
Directives 2000/53/EC and 2005/64/EC (COM (2023) 451 final).
37
Proposal for a Regulation of the European Parliament and of the Council on the safety of toys and repealing Directive
2009/48/EC (COM(2023) 462 final).
15
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from the substance restrictions, verify its completeness, get an opinion of its Committee for Socio-Economic
Analysis and if necessary from its Committee for Risk Assessment and submit the opinions to the Commission.
15. POPs regulation
The proposal for amendment of the POPs regulation via the omnibus regulation on (re-)attribution of tasks
adopted as part of the one substance, one assessment package proposes to
reattribute the existing tasks
performed by the Commission to
ECHA
and
EEA
and
improve how those tasks are executed.
On the request
of the Commission, ECHA is expected to provide assessments underpinning setting concentration limit values
for substances subject to waste management provisions as part of the review of Annexes IV and V of the POPs
regulation. As part of that assessment, ECHA is required to prepare a report on the assessment with the proposal
for concentration limit values, get opinion of its Committee for Socio-Economic Assessment on the report and
submit the opinion to the Commission as an input for amendment of Annexes IV and V via the delegated act.
EEA is expected to host the chemical monitoring data in the environment of the POPs listed in Annex III, Part
I.
16. Medical devices regulation
The proposal for amendment of the medical product regulation via the omnibus regulation on (re-)attribution
of tasks adopted as part of the one substance, one assessment package proposes to
reattribute the existing
tasks
performed by the Commission and its Scientific Committee on Health, Environmental and Emerging
Risks (SCHEER) to
ECHA.
ECHA is required every 5 years to review the guidelines on how to perform the
benefit-risk assessment of the presence of phthalates in medical devices. In addition, on the request of the
Commission, ECHA is required to prepare and review the guidelines on how to perform the benefit-risk
assessment of the presence of carcinogenic, mutagenic, reprotoxic or endocrine-disrupting substances in
medical devices.
17. EEA founding regulation
The proposal for amendment of the EEA founding regulation via the omnibus regulation on (re-)attribution of
tasks adopted as part of the one substance, one assessment package proposes to
better specify existing tasks
of
EEA.
EEA is given a mandate to develop assessment methodologies related to chemicals within the mission
of the agency and EEA is required to actively cooperate with other EU Agencies as regards exchange of data
and development of methodologies. The goal is to ensure coherence, consistency and interoperability in the
specified areas.
18. General Food Law
The proposal for amendment of the General Food Law establishing EFSA via the omnibus regulation on (re-
)attribution of tasks adopted as part of the one substance, one assessment package proposes to
better specify
existing tasks
of
EFSA.
EFSA is required to actively cooperate with other EU Agencies as regards exchange
of data and development of methodologies. EFSA is further required to engage more in preventing or solving
a divergent opinion with other EU Agencies. The goal is to ensure coherence, consistency and interoperability
in the specified areas.
19. Common Data Platform on Chemicals
The proposal for a regulation establishing a common data platform and a monitoring and outlook framework
for chemicals adopted as part of the one substance, one assessment package assigns
new tasks
to
ECHA,
EEA, EFSA, EMA and EU-OSHA.
ECHA is requested to set up and operate the common data platform on
chemicals, including the database of standard formats and controlled vocabularies. All agencies are requested
to make the data on chemicals they hold available to the platform in appropriate formats for sharing among the
authorities, to set formats and controlled vocabularies in their area of competence so data can be easily shared
and to cooperate with ECHA and among each other in developing and operating the common data platform.
20. Information platform for chemical monitoring (IPCHEM)
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The proposal for a regulation establishing a common data platform and a monitoring and outlook framework
for chemicals adopted as part of the one substance, one assessment package proposes to
reattribute the
existing task
performed by the Commission to
ECHA
and
EEA.
ECHA is required to operate the IPCHEM
as part of the common data platform on chemicals and host occupational monitoring data. EEA is requested to
collect and host the human biomonitoring data and host environmental occurrence data and indoor air quality
data. The proposal will also
formalise the tasks
of ECHA, EFSA, EEA, EMA and EU-OSHA to provide
available chemical monitoring data to ECHA for integration into IPCHEM.
21. Information on regulatory processes on chemicals
The proposal for a regulation establishing a common data platform and a monitoring and outlook framework
for chemicals adopted as part of the one substance, one assessment package proposes to
extend the existing
task
currently managed by
ECHA.
ECHA is requested to continue operating the (public) activities
coordination tool ((P)ACT) system and extend it to other pieces of legislation.
EFSA, EEA and EU-OSHA
are required to provide the relevant information to ECHA.
22. Repository of reference values
The proposal for a regulation establishing a common data platform and a monitoring and outlook framework
for chemicals adopted as part of the one substance, one assessment package proposes a
new task
to
ECHA,
EFSA, EEA, EMA and EU-OSHA.
ECHA is requested to set up, operate and populate with scientific and
regulatory reference values a repository of reference values and to collate in it the regulatory reference values.
EFSA, EEA, EMA and EU-OSHA
are required to cooperate with ECHA in the operation of the repository
and provide to ECHA the scientific reference values they derive.
23. Information on regulatory processes on chemicals
The proposal for a regulation establishing a common data platform and a monitoring and outlook framework
for chemicals adopted as part of the one substance, one assessment package proposes to formalise and
expand
the existing task
ECHA is already carrying out with the EU chemicals legislation finder (EUCLEF).
ECHA
is required to continue the operation of EUCLEF and extend it to cover all relevant legislative pieces on
chemicals.
24.
Database on environmental sustainability related data
The proposal for a regulation establishing a common data platform and a monitoring and outlook framework
for chemicals adopted as part of the one substance, one assessment package proposes a
new task to ECHA.
ECHA is requested to set up and operate a database with environmental sustainability data on chemicals.
ECHA, EEA, EFSA, EMA and EU-OSHA are required to make available to the ECHA any environmental
sustainability related data they host or hold. The agencies also need to provide the necessary technical
cooperation to ECHA to enable the integration of the data in the common data platform on chemicals.
25.
Data generation mechanism
The proposal a regulation establishing a common data platform and a monitoring and outlook framework for
chemicals adopted as part of the one substance, one assessment package proposes a
new task
to
ECHA
and
EFSA.
ECHA is required to commission studies in support of the implementation of chemicals legislation and
to contribute to the support, evaluation or development of EU chemicals policy. ECHA is required to do it on
its own initiative or on the request of the Commission. The procedure is complementary to the existing
procedure operated by EFSA under Article 32 of the General Food Law and ECHA and EFSA should cooperate
in designing and commissioning the studies under both procedures.
26. Mechanism for notification of studies and database for study notifications
The proposal for a regulation establishing a common data platform and a monitoring and outlook framework
for chemicals adopted as part of the one substance, one assessment package proposes a
new task
to
ECHA.
ECHA is required to set up a database of study notifications for studies beyond the food sector (i.e. for studies
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not already subject to the notification obligation of Article 32b of the General Food Law and notified to EFSA).
ECHA and EFSA are required to cooperate to ensure compatibility of the respective systems. ECHA is
expected to control fulfilment of the obligations to notify the studies as part of the compliance check under
REACH and as part of approval of biocidal active substances and products.
27. Early warning and action system for emerging chemical risks and framework of indicators
The proposal for a regulation establishing a common data platform and a monitoring and outlook framework
for chemicals adopted as part of the one substance, one assessment package proposes a
new task
on an early
warning and action system to
EEA, ECHA, EFSA, EMA and EU-OSHA. It also proposes to formalise the
existing task
on an indicator framework performed by
EEA and ECHA.
For the early warning system, EEA
is required to compile and collect annually the early warning signals into a report to be presented to the Member
State authorities, relevant EU agencies and the Commission to consider whether any regulatory action is
needed. ECHA, EFSA, EMA and EU-OSHA are required to cooperate with EEA and provide early warning
signals from their areas of responsibility. For the framework of indicators, EEA and ECHA are required to
operate and populate the indicator framework for chemicals policy.
28. Observatory for specific chemicals with potential contribution to emerging chemical risks
The proposal for a regulation establishing a common data platform and a monitoring and outlook framework
for chemicals adopted as part of the one substance, one assessment package proposes to
formalise the existing
task
performed by
ECHA
and
expand
its scope. ECHA is required to continue operating the existing
observatory for nanomaterials and extend its scope to chemicals and materials of potential emerging risk.
29. Cooperation of ECHA with other EU agencies
The proposal for the regulation on ECHA will consider proposing
a new task to ECHA
and
better specify
the existing tasks.
ECHA should be given a formal mandate to develop methodologies for assessment of
chemicals in the areas falling within its mission. ECHA should be required to actively cooperate with other
EU Agencies as regards exchange of data and development of methodologies. Finally, ECHA should be further
required to engage more in preventing or solving a divergent opinion with other EU Agencies. The goal is to
ensure coherence, consistency and interoperability in the specified areas.
30. Scientific opinions on occupational exposure limits
The proposal for the regulation on ECHA will consider to
formalise the existing task
of
ECHA.
ECHA and
its Committee for Risk Assessment should be given a legal mandate to provide opinions on occupational
exposure limits in support of the Directive on carcinogens, mutagen or reprotoxic substances at work, Chemical
Agent Directive and Asbestos Directive. ECHA already does so, but without a formal mandate and via a service
level agreement with the Commission.
31. REACH regulation
38
The proposal for a REACH revision will consider proposing
changes in the existing
tasks of
ECHA.
ECHA
should be required to implement the changed tasks. This should include expanded registration obligations (to
polymers), changes in the restriction (expansion of the generic approach to risk management) and authorisation
procedures and changes in enforcement provisions.
32. Cosmetic products regulation
39
The proposal for the targeted revision of the Cosmetic Products Regulation will consider proposing
reattribution of existing tasks
to
ECHA.
ECHA should be required to take over hosting of the Scientific
Committee on Consumer Safety (SCCS) which assesses the safety of chemicals underpinning the process for
the authorisation of colorants, preservatives and UV-filters, the process for prohibition or restriction of
ingredients used in cosmetic products where concerns are raised due to potential risks to human health, the
38
39
Chemicals legislation – revision of REACH Regulation to help achieve a toxic-free environment (europa.eu)
EU chemicals strategy for sustainability – Cosmetic Products Regulation (revision) (europa.eu)
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process for granting an exemption from the prohibition of chemicals that cause cancers, gene mutations, affect
the reproductive or endocrine system and the process for examining the safety of substances used in cosmetic
products that could affect the respiratory system and chemicals toxic to a specific organ. ECHA and its
committee should be also required to produce a technical guidance document concerning different aspects of
testing and safety evaluation of cosmetic substances including for nanomaterials used is cosmetics.
33. Non-chemical assessments performed by SCHEER
The Commission Decision on discontinuing the operation of scientific committees SCHEER and SCCS will
result in
reattribution of existing tasks
to
the Commission Scientific Advisory Mechanism (SAM).
SAM
will be required on the ad hoc basis to provide a scientific advice on non-chemical topics currently provided
by SCHEER.
34. Ecodesign for sustainable products regulation
40
The proposal for regulation on eco-design for sustainable products envisages some new tasks that could be
potentially attributed to EU Agencies. These tasks are not defined in the proposal but rather to be specified in
the envisaged implementing acts. Such envisaged tasks include involvement of ECHA in the development of
a product passport that should hold also information on substances of concern.
35. Tobacco products directive
41
The tobacco directive is undergoing an evaluation and a revision of the directive is being envisaged. As part
of the revision, a new scientific and technical work is being envisaged that could be potentially attributed to
EU Agencies. This includes managing the laboratory network on tobacco control, checking compliance with
product presentation provisions, running the procedure determining characterizing flavour, updating
negative/positive lists of additives, hosting product database and making publicly available the product
information, monitoring of data in product notifications and assessing information on leaflets. The tasks are
not yet clear but those that are being considered do not naturally fit to the agencies considered in this initiative.
36. Regulation on fluorinated greenhouse gases
42
and the Regulation on ozone depleting substances
43
The proposal for a regulation on fluorinated greenhouse gases establishes an obligation on the Commission to
operate an electronic system for the management of the quota system, licensing of imports and exports and
reporting and introduces invoicing fees for the quotas. Similarly for the Regulation on ozone depleting
substance, the Commission has the obligation to operate a licencing and reporting system. It is not yet clear
how the tasks can be implemented most effectively, but it is envisaged that an agency could take some of the
tasks in case that would be deemed to be the best option at a later stage.
7.
A
SSESSMENT OF IMPACTS
The fitness check of all chemical legislation (excluding REACH) assessed most of the challenges and risks
addressed through this initiative and concluded that there are significant opportunities for streamlining the
technical and scientific work through EU agencies. Moreover, there is little discretion of the policy choice as
to achieve objectives of the initiative. The consolidation of the technical and scientific work on chemicals at
the EU level is possible only in the EU Agencies. Therefore, no formal impact assessment was carried out.
Overall impact
Although no formal assessment of social, economic and environmental impacts was carried out, such impacts
were qualitatively assessed by the Commission with the help of external consultants. The outcomes of the
40
Proposal for a Regulation of the European Parliament and of the Council establishing a framework for setting eco-
design requirements for sustainable products and repealing Directive 2009/125EC (COM (2022) 142 final).
41
Evaluation of the legislative framework for tobacco control (europa.eu)
42
Proposal for a Regulation of the European Parliament and of the Council on fluorinated greenhouse gases, amending
Directive (EU) 2019/1937 and repealing Regulation (EU) No 517/2014 (COM (2022) 150 final).
43
Proposal for a Regulation of the European Parliament and of the Council on substances that deplete the ozone layer
and repealing Regulation (EC) No 1005/2009 (COM (2022) 151 final).
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assessment is provided in the sub section ‘overall impact’ of the section 8 for the legislative proposals on
reattribution of tasks and of the section 9 for the legislative proposal for a regulation establishing a common
data platform and a monitoring and outlook framework for chemicals. The overall impacts from all
reattributions are summarised in the section 10.1. ‘added value and synergies of the (re-)attributions’.
Assessment of impacts on resources and committees of EU agencies
As the (re-)attribution of tasks to EU agencies will have a major impacts on their resource and capacity needs,
these impacts were assessed in great detail. Assessment of impacts of the (re-)attribution of each task to the
EU Agencies included assessment of synergies and added value of the (re-)attribution, estimation of the
impacts on Agencies’ committees, data model and IT infrastructure and key experts and estimation of the
workload and associated resource needs for the Agencies. For the existing tasks to be reattributed, the
assessment also included description of the current workload and estimation of the current use of resources.
The detailed assessment of impacts for each task per legislation or work package is provided in
Annex III.
The estimation of the current resource use included an estimation of the full time equivalents dedicated to the
tasks. This consisted of the estimation of the full time equivalent of the Commission staff as well as estimation
of the full-time equivalents of the contracted staff (external and intramurous consultant, interim staff). To
convert the cost of consultants into full time equivalents, the cost of 1 full time equivalent of a consultant was
estimated based on the contracts and average Belgium salary at ca. EUR 66 000 annually
44
. It should be noted
that the estimation of full-time equivalents for the Commission staff does not include administrative or IT
overhead of the Commission.
The estimation of the resource needs for the Agencies was done in close and frequent consultation with the
Agencies concerned. The operation of each (re-)attributed task to Agencies has been assumed to be done
through implementing similar processes and similar level of scientific scrutiny and digitalisation to what is
already in place for Agencies’ current tasks. The benefit of this approach is to ensure a consistent standard of
scientific quality, transparency and data interoperability as well as to maximise the reuse of existing processes
and tools. In general, internal experts were assumed to be used for scientific and technical work underpinning
assessments related to chemicals and the agencies’ committees to be used to validate the work through
provisions of opinions. External contracting was envisaged for the IT development as well as for the collection
of data or information.
ECHA is the agency to receive most of the assessment work on chemicals. The estimation of the resource
needs for the new assessment task to be allocated to ECHA was built on the ECHA’s experience of the resource
needs for their existing processes. The experience shows that resource requirement for the development of an
opinion on harmonised classification varies between 0.35 – 0.65 FTEs per dossier (0.35 for low complexity
dossier, 0.5 for average complexity and 0.65 FTE for complex dossier), for scientific opinion on the
occupational exposure limit values is average of 0.7 FTE per dossier, for opinion on REACH authorisation is
0.15 FTE pre dossier of low complexity up to 0.35 FTE per dossier of high complexity, for opinion on REACH
restriction is 1 FTE per dossier of low complexity up to 1.5 FTE per dossier of high complexity. An overhead
of 15% was added to the resource estimate for the development and maintenance of common IT components
and additional 15% for the contribution to the horizontal support (governance & enablers / administrative
overhead).
8.
I
MPACTS OF THE LEGISLATIVE PROPOSALS ON REATTRIBUTION OF TASKS
Overall impact
Overall, this proposal is expected to improve the efficiency, effectiveness, coherence and transparency of EU
processes for chemical assessments for the benefit of all stakeholders. Citizens and the environment will
benefit from better protection from dangerous chemicals as a result of more efficient and effective assessment
processes. Companies will benefit from more harmonised and transparent processes across legislation, from a
44
This number corresponds to a medium to high BE annual salary cost (see e.g.
An overview of Belgian wages and
salaries | Statbel (fgov.be)); Belgian average salaries were used because many companies contracted by the Commission
are based on Belgium.
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reduced number of bodies involved in safety and risk assessments, as well as from strengthened certainty
regarding the validity of assessments. Finally, the national and EU authorities will benefit from improved
efficiency of delivery of assessments and improved public trust and acceptance of regulatory decisions.
•
Improved scientific consistency and coherence of assessments
–
The reduced number of actors
involved in the scientific and technical work, as well as an increased cooperation and obligation to solve
divergent opinions among agencies leads to improved coherence and scientific consistency - both across
the various Union acts, and across the assessment processes laid out therein. The consolidation of work
allows to better align priority setting, timelines, processes, and methodologies used for the assessments.
It facilitates re-use of assessment insights developed under one Union act on chemicals in the assessment
process of another.
•
Improved robustness of assessment, trust and acceptance of regulatory decisions
–
The
involvement of the EU agencies and their committees in the scientific and technical work on chemicals
adds more scientific expertise, ensures high quality of scientific advice and leads to improved robustness
of assessments and thus their acceptance.
•
Strengthen independence of the scientific advice
– Moving scientific and technical work on chemicals
from the Commission, ad hoc committees or consultants to EU agencies and their committees reinforces
the independence of the scientific advice and the separation between science and policy or between risk
assessment and management. Agencies are independent and their committees work under stricter
conflict of interest avoidance rules, improving guarantees of independent scientific advice to the
Commission.
•
Improved transparency
– The involvement of the EU agencies in scientific and technical work will
ensure transparency to the process in terms of overall process transparency.
•
Improved efficiency of delivery of assessments
– Centralising assessment work in the EU agencies
will allow the re-use of capabilities, the re-use of knowledge and experience, and the re-use of IT tools
and support services.
Impact on resources of Agencies and the Commission
The proposal for a directive on reattribution of tasks will amend RoHS directive to reattribute the assessment
work under this directive to ECHA. The proposal for a regulation on reattribution of tasks will amend 2
legislative pieces (POPs Regulation and Medical devices regulation) to reattribute the assessment work under
these pieces of legislation to ECHA and it will amend the EEA founding regulation and the general food law
(EFSA founding regulation) to ensure better cooperation among agencies on methodology development and
on exchange of data. In summary for these two proposals on reattribution, in the first year, there will be a need
of
4 FTEs
(4
TAs)
and operational costs of
EUR 101 000
per year and as of the second year, there will be a
need of
9 FTEs (6 TA + 3 CA)
per year and operational budget of
EUR 83 000 per year.
All new resources
are needed for ECHA, no additional resources are needed for EEA and EFSA. Considering the resources
currently used for the tasks to be reattributed, there will be a total
net increase
in the resources from 2026 and
beyond as compared to today of
4.5 FTEs
per year and
EUR 59 000 per year.
Table 2. Resource needs per legislation amended via the directive and regulation on reattribution of tasks (operational costs
in EUR 1 000)
FTEs
Legislation
2025
TA
CA
2026
TA
CA
2027
TA
CA
2028
TA
CA
2025
Operational costs
2026
2027
2028
Proposal for a directive on reattribution of
scientific and technical work
RoHS directive
3
0
4
3
4
3
4
3
66
33
33
33
Proposal for a regulation on reattribution of scientific and technical work
POPs regulation
Medical devices regulation
EEA founding regulation
1
0
0
0
0
0
2
0
0
0
0
0
2
0
0
0
0
0
2
0
0
0
0
0
35
0
0
50
0
0
50
0
0
50
0
0
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General food law (EFSA founding
regulation)
SUM
0
4
0
0
0
6
0
3
0
6
0
3
0
6
0
3
0
101
0
83
0
83
0
83
Table 3. Current resource use for technical and scientific work to be reattributed to ECHA
RoHS directive
•
Assessments underpinning restrictions of hazardous
substances in electrical and electronic equipment
•
Review of applications for exemptions from the restrictions
Total ca. 2.74 FTEs/year: EUR 145 000 annually (on average) for
outsourcing the review of exemptions (= ca. 2.2 FTEs/year) + a
contract of EUR 180 000 on average each 5 years for reviewing
restrictions (= 0.54 FTE/year). (In addition, DG ENV ca. 1.5
FTE/year (for overall RoHS implementation) whose work will
remain).
Total ca. 1.5 FTEs/year: EUR 300 000 for consultants every 3
years (=1.5 FTE/year). (In addition, DG ENV ca. 0.5 FTE/year
(implementing the review of Annexes IV and V) whose work will
remain).
Total ca. 0.3 FTE/year + EUR 24 000/year: DG SANTE SCHEER
secretariat 0.3 FTE (ca. 10% of SCHEER secretariat work), EUR
24 000/year for indemnities, travel,
e.g.
costs for members of the
committee. (In addition, DG SANTE (policy unit) 0.1 FTE/year
whose work will remain).
POPs regulation
•
Technical assistance in reviewing Annexes IV and V
•
Hosting POPs monitoring data
Medical devices regulation
•
Preparation and review of the guidelines on how to perform
the benefit-risk assessment of the presence of phthalates in
medical devices
•
Preparation and review of the guidelines on how to perform
the benefit-risk assessment of the presence of CMR and
endocrine-disrupting substances in medical devices
SUM
0.3 FTEs/year of regular staff; 4.2 FTEs/year of intramurous
contractors or interim staff (ca. EUR 281 000/year);
Operational costs of ca. EUR 24 000/year
Changes to RoHS directive
will reattribute the assessments underpinning restrictions of hazardous substances
in electrical and electronic equipment and review of applications for exemptions from the restrictions to
ECHA. For this work, ECHA will require in the first year 3 FTEs (3 TAs) and operational budget of EUR 66
000 and as of the second year 7 FTEs (4 TAs + 3 CAs) per year and operational budget of EUR 33 000 per
year. The work is currently performed with the help of consultants and amounts to approximately 2.74 FTE
per year (ca. EUR 145 000 annually for outsourcing the review of exemptions (ca. 2.2 FTEs/years) + ca. EUR
180 000 every 5 years for contracts to review restrictions (ca. 0.54 FTE/year)). DG ENV uses ca. 1.5 FTE of
core staff for overall RoHS implementation, which will need to continue. The resources currently spent are
however insufficient leading to the accumulation of requests for exemptions without processing them to the
legal drafting (by December 2022, over 60 exemption requests were pending) and the revision of the restriction
was delayed (the review not finalised although it has started in 2018). There are also complaints about the
quality and robustness of the assessments, the transparency of the process and involvement of stakeholders.
The reattribution to ECHA and using its processes will address these shortcomings and will ensure alignment
with other chemicals legislation.
Changes to POPs regulation
will reattribute the technical assistance in reviewing Annexes IV and V to ECHA
and hosting the POPs monitoring data to EEA. For this work, ECHA will require in the first year 1 FTE (1
TA) and operational budget of EUR 35 000 and as of the second year 2 FTEs (2 TAs) per year and operational
budget of EUR 50 000 per year. No resources are needed for EEA. The work on reviewing the Annexes IV
and V is currently performed by the Commission with the help of consultants and amounts to approximately
1.5 FTEs per year (EUR 300 000 for consultants every 3 years (=1.5 FTE/year)). DG ENV uses ca. 0.5
FTE/year of core staff for implementing the review of Annexes IV and V, which will however need to continue.
The involvement of ECHA and its Committee for Socio-Economic Analysis is envisaged to provide a
significant increase in the scientific quality, the consistency, the robustness and the level of independence of
the assessments upon which the Commission develops its proposals on this matter. The hosting of chemicals
monitoring data under the POPs regulation is currently done by the Commission. Transfer of this work to EEA
will require no additional resources, as POPs monitoring data in waters are to be reported to EEA under the
water legislation and resources for that were proposed in the recent proposal, the POPs monitoring data in air
are already being reported to EEA as part of the air quality legislation and covered by resources for that activity.
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In addition, hosting of any additional data sets in the environment is also covered in the resource for common
data platform.
Changes to medical devices regulation
will not require any additional resources for ECHA. The work is
currently performed by the Commission supported by the SCHEER committee. The current resource use is
estimated to be 0.3 FTE per year and EUR 24 000 per year (DG SANTE SCHEER secretariat 0.3 FTE (ca.
10% of SCHEER secretariat work), EUR 24 000 per year for indemnities, travel, e.g. costs for members of the
committee). DG SANTE uses (policy unit) uses ca. 0.1 FTE of core staff per year for implementation of the
related provisions, which will however need to continue. Considering that the envisaged frequency of the work
is very low, the involvement of the Committees is only where necessary and the first work will likely
materialise only in 2029, the work can be absorbed by ECHA without any additional resources.
Changes to the regulation on the European Environment Agency and to the regulation on the general
principles and requirements of food law and establishing the European Food Safety Authority
will have
no resource implications. The provisions formalise the activities already performed, they prescribe the
procedural steps to follow and they enable the implementation of the proposal for a regulation establishing a
common data platform on chemicals, laying down rules to ensure that the data contained in it are findable,
accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals.
Any possible resource needs stemming from these provisions can be absorbed by the existing resources of the
agencies.
Impact on committees of Agencies
There will be an impact on ECHA’s committees for risk assessment and for socio-economic analysis. It is
estimated that the
committee for risk assessment
will have to process
ca.
4 opinions per year:
one opinion
on new restriction of a substance (which is of equivalent of low complexity restriction under REACH) and 3
opinions per year on requests for new exemptions (which is expected to be lighter dossier than the low
complexity restriction dossier under REACH) under RoHS. The
committee for socio-economic analysis
is
expected to process
ca.
33 opinions per year:
1 opinion on restriction of a substance and 30 opinions on the
requests for exemption under RoHS, and 2 opinions on the revision of Annex IV and V and the proposed limit
value under the POPs regulation.
Table 4. Expected number of opinions from ECHA’s committees per year and per legislation
RAC
RoHS directive
- Restriction
- Request for exemption
POPs regulation
- Review of Annexes IV and V
SUM
1
3
-
4
SEAC
1
30
2
33
9.
I
MPACT OF THE LEGISLATIVE PROPOSAL FOR A REGULATION ESTABLISHING A COMMON DATA
PLATFORM AND A MONITORING AND OUTLOOK FRAMEWORK FOR CHEMICALS
Overall impact
Overall, this proposal is expected to contribute to an improvement of the efficiency, coherence, quality and
transparency of chemicals assessments under EU legislation as well as to the early identification of emerging
chemicals risks. It will therefore improve the protection of human health and the environment from chemicals,
for the benefit of Member State authorities, stakeholders and citizens. In addition, the initiative simplifies
access to chemicals information for everyone (citizens, industry, national authorities, EU agencies, the
Commission) thus increasing transparency. Moreover, it will improve predictability and thus the possibility
for the industry, national authorities and EU agencies to plan – and where relevant coordinate – their activities:
•
Bringing together chemicals data in one common data platform will increase findability and simplify
access, which is beneficial for all users. The platform will operationalise the ambition of the one-
substance one-assessment approach, supporting quality and mutual coherence of chemicals
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•
•
•
•
•
•
•
assessments. The use of standard formats and controlled vocabularies will enhance interoperability of
information, thus increasing its findability. In addition, information across regulatory dossiers will be
easier to compare. An increased findability and comparability will in turn reduce administrative burden
for risk assessors, which include national administrations, and have a positive impact on the
effectiveness, efficiency and coherence of chemical safety assessments.
Through the extended utility of shared information in the common data platform, this proposal will
help minimise potential duplication of efforts and optimise data generation strategies. With an
increased volume and transparency of data on chemical properties and supported by adequate context
data that enables the responsible use of that chemicals data, compliance with and enforcement of
existing obligations should be facilitated.
Building on integrated access and services the common data platform is expected to provide additional
insight into effective risk management measures and to facilitate the search for safe and sustainable
alternatives, leading to improvements in the protection of human health and the environment.
Bringing together chemicals data and being allowed to use it will increase the knowledge base for
scientific assessments and opinions, thus improving their robustness. This will in turn increase the
acceptance by society of conclusions and regulatory decisions. Knowing through the notification of
studies that all studies have been considered in an assessment further strengthens the trust of citizens
in regulatory decisions.
A dedicated service in the common data platform related to information on regulatory processes
planned or ongoing by the Commission, EU agencies and Member States will improve the
coordination of activities, which in turn will allow better planning for the authorities and agencies
involved, thus increasing efficiency. That information will also allow better predictability and planning
for industry, facilitating receipt of comprehensive but also consistent input to the activities, where
required. It will be easier for industry but also other stakeholders to know when and how to contribute
to regulatory processes.
A dedicated service in the common data platform related to obligations under EU legal acts on
chemicals will be very valuable for industry, and in particular for SMEs and microenterprises, to easily
get an overview of their legal obligations, which will give them certainty on what exactly their duties
are. Acting with such full knowledge in turn supports compliance and correspondingly reduces burden
on national authorities.
The establishment of a monitoring and outlook framework including an early warning and action
system for emerging chemical risks will allow to shorten the reaction time between early signals of
risks and regulatory measures to reduce those rusks, and as such will lead to an improved protection
of human health and the environment.
The establishment of a data generation mechanism allows the commissioning of studies when there
are no legal provisions to obtain them. This will contribute to the creation of a complete knowledge
base.
The establishment and operation of the platform will not impose any costs on industry. Economic operators
will continue to have to fulfil their legal obligations as they are doing today under the relevant specific pieces
of legislation. Economic operators and laboratories will experience some administrative burden linked to the
requirement to submit a notification when a study is intended to be commissioned or carried out. Quantified
costs associated with the notification obligation are set out in the staff working document accompanying this
proposal
45
.
The establishment of the platform will be associated with significant costs for the EU agencies, but they should
principally be seen as investment in technical progress within the data economy, enhancing the value of
existing and future data. The task requires investment in entirely new data structures and IT
45
Commission staff working document accompanying the document Proposal for a Regulation of the European
Parliament and of the Council establishing a common data platform on chemicals, laying down rules to ensure that the
data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook
framework for chemicals.
24
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2795275_0026.png
systems/capabilities, principally on the ECHA’s side, but also on the side of other EU agencies as data source
owners who are to prepare datasets for integration in the platform.
Impact on resources of Agencies and the Commission
The legislative proposal for a regulation establishing a common data platform and a monitoring and outlook
framework for chemicals consists of 10 distinct activities that will have an impact on the resource needs of
ECHA, EEA, EFSA, EMA and the Commission. The first three years there will be a need for up to
32 FTEs
(12 TA + 20 CA) per year
and an operational budget of up to
EUR 8 657 000 per year.
In the fourth year
and beyond, there will be a need of
20 FTEs (12 TAs and 8 CA)
per year and
EUR 7 080 000
per year.
Considering the resources currently used for the existing tasks to be reattributed (i.e. resources for IPCHEM),
there will be a total
net increase
in the resources in the fourth year and beyond as compared to today of
15.5
FTEs
per year and operational budget of
EUR 7 080 000 per year.
Table 5. Resource needs per activity of the legislative proposal for a regulation establishing a common data platform and
a monitoring and outlook framework for chemicals (operational costs in EUR 1 000)
FTEs
Operational costs
Activity
2025
2026
2027
2028
2025
2026
2027
2028
TA CA TA CA TA CA TA CA
Common data platform
5 16
5 16
5 16
5
4
950
3 442
4 077
1 300
Information Platform for Chemical
Monitoring (IPCHEM)
Information on regulatory processes on
chemicals
Repository of reference values
Information on the obligations under
Union acts on chemicals
Environmental sustainability related data
on chemicals
Data generation mechanism
Mechanism for notification of studies and
database for study notifications
Early warning and action system for
emerging chemical risks and framework of
indicators
Observatory for specific chemicals with
potential contribution to emerging
chemical risks
SUM
1
0
1
0
0
1
1
1
0
0
0
0
0
0
2
0
2
0
1
0
1
1
1
1
1
0
0
0
0
1
2
0
2
0
1
0
1
1
1
1
1
0
0
0
0
1
2
0
2
0
1
0
1
1
1
1
1
0
0
0
0
1
2
0
0
0
0
0
0
0
0
0
200
0
650
0
0
1 000
1 200
300
380
0
650
0
0
3 000
400
150
230
0
200
0
0
5 000
200
150
0
0
0
0
0
0
0
0
0
0
0
0
10
18
12
20
12
20
12
8
950
6 792
8 657
7 080
Table 6. Current resource use for existing activities that are (re-)attributed
IPCHEM
Information on regulatory
processes on chemicals
Total 4.5 FTEs/year: DG JRC staff 2.5 FTEs/year + IT experts intramurous 2 FTEs/year (EUR 130
000 per year).
ECHA already operates (P)ACT for REACH, CLP and POPs processes. EFSA already operates
OpenEFSA which has a similar level of information as PACT. Resources for the operation and
continuous provision of information are to be absorbed by the Agencies.
ECHA already operates EUCLEF and this is financed through the contribution agreement between
DG GROW and ECHA: Total ca. EUR 1.0 - 1.4 million annually, with no posts. ECHA runs the
service through the employment of 4 interim staff members (ca. EUR 270 000/year) and via
contractors: communication activities and external helpdesk
ca.
EUR 60 000/year, IT costs EUR
200 000/year, data costs EUR 430 000/year. No additional resources needed but the formalisation
of the resource allocation should be done via the proposal for a regulation on ECHA.
ECHA already operates the EU Observatory on Nanomaterials and this is financed via a
contribution agreement between DG GROW and ECHA: Total of EUR 700 000 annually including
3 CAs/year. No additional resources needed but the formalisation of the resource allocation should
be done via the proposal for a regulation on ECHA.
2.5 FTEs/year of regular staff; 2 FTEs/year of intramurous contractors or interim staff (ca.
EUR 130 000 per year)
Information on the obligations
under Union acts on chemicals
Observatory for specific
chemicals with potential
contribution to emerging
chemical risks
SUM
25
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The highest attribution of resources is necessary for ECHA, both in terms of FTEs and operational budget,
followed by EEA, EFSA and EMA. After initial higher numbers for the first three years (2025-2027), as of the
fourth year
ECHA
will need
13 FTEs (9 TA + 4 CA)
and an operational budget of
EUR 6 180 000
per year,
EEA
will need
3 FTEs (3 TAs)
and
EUR 400 000
per year,
EFSA
will need
2 FTEs (2 CA)
and
EUR 500
000
per year,
EMA
will need
2 FTEs (2 CAs) and EUR 0
per year and JRC
0 FTEs
and EUR
0
per year. No
additional resources are required for
EU-OSHA.
Table 7. Resource needs per agency (operational costs in EUR 1 000)
FTEs
Agency / Service
ECHA
EEA
EFSA
EMA
EU OSHA
JRC
SUM
2025
TA
CA
7
8
3
2
0
5
0
3
0
0
0
0
10
18
2026
TA
CA
9
10
3
2
0
5
0
3
0
0
0
0
12
20
2027
TA
CA
9
10
3
2
0
5
0
3
0
0
0
0
12
20
2028
TA
CA
9
4
3
0
0
2
0
2
0
0
0
0
12
8
2025
0
0
670
100
0
180
950
Operational costs
2026
2027
5 076
766
670
100
0
180
6 792
7 023
684
670
100
0
180
8 657
2028
6 180
400
500
0
0
0
7 080
Common Data Platform
will be established and operated by ECHA with close involvement and contribution
from EEA, EFSA, EMA, EU-OSHA and the Commission. The work will include development and operation
of the infrastructure and the governance and provision of data into the platform. The principal aim of new IT
infrastructure operating as part of the Green Deal Data Space is to support effective and coherent chemical
safety assessments. It shall provide integrated, user-differentiated and highly functional access to chemicals-
related datasets owned or managed by EU agencies and provide space for the dedicated services supporting
EU chemicals policy and legislative implementation. The work will require resources for 4 agencies involved
and the Commission (JRC). The resource requirement is higher for the first 3 years to set up the infrastructure
and all the underlying processes to share the data and make them interoperable and in adequate formats. This
will require for the first 3 years:
•
•
•
•
•
•
for ECHA, 10 FTEs (4 TAs + 6 CAs) per year and operational budget of EUR 0 for the first
year, EUR 2 226 000 for the second year and EUR 2 793 000 for the third year;
for EEA, 3 FTEs (1 TA + 2 CAs) per year and operational budget of EUR 0 for the first year, EUR
266 000 for the second year and EUR 334 000 for the third year;
for EFSA, 5 FTEs (5 CAs) per year and an operational budget of EUR 670 000 per year;
for EMA, 3 FTEs (3 CAs) per year and an operational budget of EUR 100 000 per year;
for EU-OSHA, 0 FTEs per year and operational budget of EUR 0 per year;
for JRC, an operational budget of EUR 180 000 per year to cover integration of IPCHEM in the
common data platform and handing over of IPCHEM operation to ECHA.
After the initial phase of 3 years, the resource requirement is reduced to maintain the infrastructure and the
underlying processes. This phase will require
•
•
•
•
•
for ECHA, 4 FTEs (4 TAs) per year and operational budget of EUR 600 000 per year;
for EEA, 1 FTE (1 TA) per year and operational budget of EUR 200 000 per year;
for EFSA, 2 FTEs (2 CAs) per year and operational budget of EUR 500 000 per year;
for EU-OSHA, 0 FTEs per year and operational budget of EUR 0 per year;
for EMA, 2 FTEs (2 CAs) per year and operational budget of EUR 0.
Information Platform for Chemical Monitoring
(IPCHEM) will be formally established and its operation
will be reattributed to the Agencies. For this work,
•
ECHA will need as of the second year 2 FTEs (1 TA + 1 CA) per year and as of the third year
operational budget of EUR 180 000 per year;
26
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•
EEA will need as of the first year 1 FTE (1 TA) per year and the operational budget in the first year
EUR 0, in the second year EUR 200 000, in the third year EUR 200 000 and as of the fourth year EUR
50 000 per year.
The operation of IPCHEM is currently done by the Commission and the resource use accounts for total of 4.5
FTEs/year (DG JRC staff 2.5 FTEs/year + IT experts intramurous 2 FTEs/year (EUR 130 000/year)). The
operation of IPCHEM will be entrusted to ECHA which will also integrate it into the Common Data Platform.
As this work will be reattributed to ECHA, the resources at the Commission’s side will be saved. Hosting of
data will be entrusted to the Agencies based on their mandates (ECHA will host occupational data) and EEA
will host indoor air data and collect and host human biomonitoring data. EFSA already provides data to
IPCHEM and contributes to its operation and will not require any additional resources to continue in this
activity. EMA and EU-OSHA currently do not systematically collect or receive data relevant for IPCHEM and
therefore will not require any additional resources.
Database containing information on regulatory processes on chemicals
will be established on the basis of
existing (public) activities coordination tool ((P)ACT) and enlarging its scope to cover all relevant legislation
with safety assessment processes and initiatives to promote coordination of safety assessment activities across
EU legislation and provide transparency on the ongoing assessments. This work will impact ECHA, EEA,
EFSA and EU-OSHA but will not require additional resources for the agencies. ECHA already operates
(P)ACT for REACH, CLP and POPs processes. EFSA already operates OpenEFSA which has similar level of
information as PACT for food and feed legislation. Resources for the operation and continuous provision of
information are to be absorbed by the Agencies as part of the existing processes. EEA and EU-OSHA are
currently not involved in any processes relevant for the database, therefore no resources are required for them.
The development and coordination of the system is covered by the resources provided for the common data
platform.
Repository of reference values
will be established to promote the reuse of existing reference values and thus
improve coherence of assessments and reduce repetition of deriving reference values. The proposal will impact
ECHA, EEA, EFSA, EMA, EU-OSHA and the Commission. To perform the required work, ECHA will need
as of the first year 1 FTE (1 TA) per year and operational budget of EUR 0 in the first year, EUR 650 000 in
the second year, EUR 650 000 in the third year and as of the fourth year EUR 200 000 per year. No additional
resources will be needed for EEA, EFSA, EMA, EU-OSHA or the Commission. ECHA has developed and
operates the EU Chemicals Legislation Finder (EUCLEF). EUCLEF lists some regulatory reference values
derived and applicable under these legislative pieces. ECHA will have to collate the ‘old scientific reference
values’ which can be done via contracting. The new scientific reference values will be provided to the
repository progressively as part of ECHA’s assessment processes. ECHA will require additional resources for
developing, operating and maintain the repository, being in contact with data providers. EFSA has developed
and is maintaining the OpenFoodTox database that summarises the scientific reference values derived by
EFSA as part of its assessment activities. EFSA will continue its activity and will provide the information to
the new repository as part of its existing resources. Therefore, no additional resources are required. EMA will
need to provide to the new repository on continuous basis all new predicted no effect concentrations (PNECs)
derived for human and veterinary medicinal products after entry into force of this legislation. This can be done
efficiently as part of EMA’s future assessment activities. In addition, this can be automatized for human
medicines as digitalisation of environmental risk assessment is foreseen as part of the revision of human
medicinal product legislation. Therefore, no additional resources are required. EEA and EU-OSHA currently
do not hold any relevant data for the repository. Therefore, no additional resources are required.
The establishment and operation of a
database with information on applicable laws and legal obligations
applicable to chemicals under Union legislation to promote compliance will be formalised. This work will
impact ECHA but will not require additional resources under this proposal. ECHA already operates EU
chemical legislative finder (EUCLEF) as part of the contribution agreement with DG GROW. The contribution
agreement amounts to ca. EUR 1.0 – 1.4 million annually. ECHA runs the service through the employment of
4 interim staff members (ca. EUR 270 000/year) and via contractors: communication activities and external
helpdesk ca. EUR 60 000/year, IT costs EUR 200 000/year, data costs EUR 430 000/year. These existing
resources will be used to continue operating, further developing and slightly expanding the system. The
27
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resources for major extension of the system, such as the repository of reference values, are provided under the
work on repository of reference values. Although no resources are required under this proposal, the legislative
proposal for a regulation on ECHA should address the fact that the operation of the EUCLEF became a
structural task for ECHA and that the financing should become part of the annual contribution to ECHA.
Database on
environmental sustainability related data on chemicals
will be established. The work will
impact ECHA. ECHA will be required to set up the database, operate it, establish and maintain the flows of
adequate data into the database and provide interpretation of data. Other agencies (EEA, EFSA, EMA and EU-
OSHA), if they host environmental sustainable data on chemicals, will provide that data to ECHA. To perform
the work, ECHA will need as of the second year 1 FTE (1 TA) per year and operational budget of EUR 0 per
year. Other agencies will not need additional resources as their task is small, currently do not hold any relevant
data and the potential work can be absorbed by the agencies’ current resources.
Data generation mechanism
will be established to allow ECHA and the Commission to commission studies
supporting the implementation of Union chemicals legislation within ECHA’s mandate or contributing to the
development of Union chemicals policy. The studies can be commissioned only when results cannot be
obtained through existing legal provisions and they shall not have predominant research and development
objective. The mechanism will allow ECHA and the Commission to generate data where needed and cannot
be obtained otherwise. ECHA’s involvement is necessary as commissioning of such studies requires technical
expertise. To perform the work, ECHA will require in the first year 1 FTE (1 TA) and operational budget of
EUR 0, in the second year 2 FTEs (1 TA and 1 CA) and operational budget of EUR 1 000 000, in the third
year 2 FTEs (1 TA and 1 CA) and operational budget of EUR 3 000 000 and as of the fourth year 2 FTEs (1
TA and 1 CA) per year and operational budget of EUR 5 000 000 per year. No current process exists, but there
is a complementary process operated by EFSA for the food sector (4 FTEs/year, EUR 15 000 000/year). This
will continue to be operated next to the new one and the two Agencies (ECHA and EFSA) are required to
cooperate when commissioning such studies and develop a joint plan.
The
obligation to notify studies
before they start will be expanded from food sector to all chemical sector.
The work will require additional resource for ECHA. ECHA will need as of the first year 3 FTEs (1 TA and 2
CAs) per year and operational budget in the first year of EUR 0, in the second year EUR 1 200 000, in the
third year EUR 400 000 and as of the fourth year EUR 200 000 per year. ECHA will be required to develop
the database, operate it, facilitate and check compliance with the provisions and provide feedback to the duty
holders. EFSA already operates a database of notification of studies to serve the obligation under the food
sector legislation. The resource use amounts to 2 FTEs/year and EUR 400 000/year. EFSA and ECHA will be
required to ensure compatibility of the systems. No additional resources are needed for this for EFSA.
The operation of the
indicators framework for chemicals
will be formalised and an
early warning and
action system for chemicals
will be established. The work will require additional resources for EEA. EEA
will need as of the first year 1 FTE (1 TA) per year and operational budget for the first year of EUR 0, for the
second year EUR 300 000 and as of the third year EUR 150 000 per year. EEA and ECHA already jointly
develop the indicators framework for chemicals as part of the commitment under the 8
th
Environment Action
Programme. As the resources for indicator framework (2 FTEs per year for ECHA, 1 FTE per year for EEA)
were already attribution as part of the 8
th
EAP, no additional resources are needed for this work. The
establishment of the early warning and action system is a new, non-existing task that aims to significantly
shorten the regulatory response to identified risks. The EEA will be tasked to collect early warning signals
from other agencies, Member State and by its own activity and compile annually a report for discussion and
decision on the follow up with Member States authorities. Other contributing agencies (ECHA, EFSA, EMA
and EU-OSHA) will absorb the costs as part of exiting activities. In case of ECHA, the resources attributed
for the indicator framework will be partly used to support the EEA by generating relevant early warning
signals.
Observatory for specific chemicals with potential contribution to emerging chemical risks
will be
established. This will de facto formalise the operation of existing EU Observatory for nanomaterials and extend
its scope to specific chemicals considered to benefit from additional scrutiny and reliable information on their
properties, safety aspects, uses and market presence. This work will impact ECHA but will not require
28
 kom (2023) 0783 - Ingen titel
additional resources under this proposal. ECHA operates the EU Observatory for nanomaterials as part of a
contribution agreement with DG GROW. The resource use amounts to approximately EUR 700 000 per year
including the 3 FTEs (3 CA). These existing resources will be used to continue operating, further developing
and slightly expanding the system. The legislative proposal in preparation for a regulation on ECHA should
address the fact that the operation of the EUCLEF became a structural task for ECHA and that the financing
should become part of the annual contribution to ECHA.
Impact on committees of Agencies
There is no or a low impact of this proposal on committees of ECHA, EFSA and EMA and on the network of
EEA. The rapporteurs of ECHA, EFSA and EMA committees that derive reference values will have to record
the reference values and associated metadata into the repository of reference values or structure this
information in the opinion to enable automatic extraction of that information to the repository. In addition,
ECHA committees might be required to provide their suggestions for testing and monitoring of substances.
The network of EEA will be required to assist in the collection of human biomonitoring data and early warning
signals from member countries activities. There is no impact of this proposal on advisory groups of EU-OSHA.
10. O
VERALL IMPACTS FROM ALL
(
RE
-)
ATTRIBUTIONS
10.1
Added value
The consolidation of scientific and technical work in the EU agencies provides for several benefits:
1. Scientific consistency and coherence
-
Less actors involved in the scientific and technical work,
centralising the work in the Agencies and requiring the Agencies to cooperate and solve possible divergent
opinions leads to improved coherence and scientific consistency among the legislative pieces and among
the assessments. The consolidation of work allows to better align priority setting, timelines, processes and
methodologies used for the assessments. It facilitates reuse of assessment insights developed under one
piece of chemical legislation in the assessment under another piece of legislation. It also facilitates the
reuse of data collected under one piece of chemical legislation in the assessment under another piece of
legislation. It contributes to alignment of data formats, IT solutions, data storing practices and thus
contribute to improved interoperability of data.
2. Robustness of assessment and acceptance
-
Involvement of the EU agencies and their committees in the
scientific and technical work on chemicals adds more scientific expertise, ensures high quality of scientific
advice and leads to improved robustness of assessments and thus their acceptance. Centralising data on
chemicals in the EU Agencies will increase the knowledgebase and improve the robustness of the
scientific advice provided. Re-use of (same) data will further facilitate acceptance of conclusions.
3. Independence - Moving scientific and technical work on chemicals from Commission services, ad hoc
committees or consultants to EU agencies and their committees reinforces the separation between science
and policy or between risk assessment and management. Agencies and their committees work under
stricter conflict of interest avoidance rules, improving guarantees of independent scientific advice to the
Commission.
4. Transparency - Involvement of the EU agencies in scientific and technical work will ensure transparency
to the process in terms of
-
overall process transparency;
-
publication of regulatory intentions of EU authorities and application submission intentions
improves predictability for all stakeholders;
-
public consultation/call for evidence;
-
stakeholder involvement/observer status;
-
dissemination of scientific data and outcomes.
The increased transparency will further increase the acceptance of the outcomes and trust in the regulatory
system.
29
Added value and synergies of the (re-)attributions
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2795275_0031.png
Synergies
The EU agencies already perform similar work to the work that is to be (re-)attributed to them. The
consolidation of scientific and technical work in the EU agencies therefore provides for number of synergies:
1. Reuse of capabilities - The existing agencies’ capabilities, such as hazard, risk and exposure assessment,
development of committee opinions, development of methodologies, IT capabilities for submission of
information by industry and Member States, collection and processing of data, stakeholder consultations,
dissemination, can be reused in performing the (re-)attributed tasks.
2. Reuse of data, information and knowledge - The information collected by the agencies on substances
under one piece of legislation can be reused under other pieces of legislation. The knowledge on a
substance developed under one piece of legislation can be reused under other legislation.
3. Workload balancing - More similar work consolidated at one place allows for better balancing the
workload across the year and thus better using existing capacities at the Agencies.
4. IT tools: automation and economies of scale - Existing IT tools of the Agencies after some adaptation of
the tools or the processes can be reused to support the tasks to be reattributed to the Agencies. This
includes data submission and reporting tools, tools for case management, public consultation, interaction
with Member States, regulatory intentions management and data dissemination
5. Support services: economies of scale - Existing scientific support services (such as committee secretariat,
prioritisation and grouping of substances, substance identification, data management and dissemination)
and administrative services of the agencies can be reused to support the tasks to be (re-)attributed to the
agencies.
10.2
Overall impact on resources
Overall impact on resources per legislation and per agency
The (re-)attribution of scientific and technical work on chemicals to the EU Agencies with accompanying
resources has been already proposed under 8 legislative proposals and one research cooperation action. The
accompanying resources already attributed to the EU agencies following legislative initiatives already
proposed by the Commission and some of which are already adopted by the co-legislator vary per year (see
Table 8), with
54 FTEs (42 TA + 12 CA)
and
EUR 2 260 000
in
2024, 76 FTEs (63 TA + 13 CA)
and
EUR
1 873 000
in
2025, 92 FTEs (79 TA + 13 CA)
and
EUR 1 726 000
in
2026
and
98 FTEs (88 TA + 10 CA)
and EUR
1 463 000
in
2027.
The majority of resources were allocated to EMA (42 – 60 FTEs per year),
followed by ECHA (24 – 29 FTEs and EUR 1 257 000 – EUR 1 364 000 per year) and EEA (9 – 11 FTEs and
EUR 180 000 – EUR 919 000 per year). The majority of resources proposed for EMA are not related to the
scope of the one substance, one assessment, but to improvement of processes for authorisation of medicinal
products for human use.
Table 8. Resource already allocated or proposed (operational costs in EUR 1 000)
Activity
Already adopted by the co-legislators
Drinking water directive
Regulation on serious cross-border threats to
health
European Partnership for the Assessment of
Risks from Chemicals
Commission
implementing
decision
2022/1979 under SEVESO directive
Batteries regulation
FTEs
2024
2025
2026
2027
TA CA TA CA TA CA TA CA
3
0
0
3
2
2
0
4
1
1
6
0
0
3
2
3
0
4
1
1
7
0
0
3
2
3
0
4
1
1
8
0
0
3
2
2
1
0
3
Operational costs
2024
2025
2026
2027
510
0
289
330
158
520
0
289
70
158
530
0
289
70
25
540
0
0
70
25
Already proposed by the Commission (with resources)
E-PRTR regulation
2
0
2
0
2
0
2
0
170
70
30
30
30
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2795275_0032.png
Industrial emissions directive
Water legislation
Legislation on medicinal products for human
use
SUM
3
10
19
42
0
4
0
12
3
10
37
63
0
4
0
13
3
10
52
79
0
4
0
13
3
10
60
88
0
4
0
10
0
803
0
2 260
0
766
0
1 873
0
782
0
0
798
0
1 726 1 463
Table 9. Resources already allocated or proposed (operational costs in EUR 1 000)
FTEs
Agency
ECHA
EEA
EMA
SUM
2024
TA CA
15
9
8
3
19
0
42
12
2025
TA CA
18
10
8
3
37
0
63
13
2026
TA
CA
19
10
8
3
52
0
79
13
2027
TA CA
20
9
8
1
60
0
88
10
Operational costs
2024
2025
2026
1 341
919
0
2 260
1 364
509
0
1 873
1 257
469
0
1 726
2027
1 283
180
0
1 463
The (re-)attribution of scientific and technical work has been already proposed by the Commission also under
the revision of CLP regulation, packaging and packaging waste directive, end-of-life vehicle directive and toys
safety directive but without the allocation of resources. As the resource allocation is still pending, these
initiatives are mentioned in the table with pending resource needs below.
The re-attribution of tasks to the EU agencies is still to be proposed under 5 upcoming legislative proposals
and under the reattribution of non-chemical assessment work from SCHEER to SAM within the Commission.
After considering all possible synergies from the reattributions, the pending resource needs for the work
attributed to the EU Agencies without the resources and for the work to be attributed varies between
56 – 69
FTEs (34-38 TA + 19-31 CAs)
per year and operational budget of
EUR 1 051 000 – EUR 10 300 000
per
year. The details are provided in Table 10. The majority of the resources is to be allocated to ECHA (46 – 55
FTEs and EUR 101 000 – EUR 8 666 000 per year), followed by EEA (3 – 5 FTEs and EUR 400 000 – EUR
766 000 per year), EFSA (2 – 5 FTEs and EUR 500 000 – EUR 670 000 per year), EMA (2 – 3 FTEs and EUR
0 – EUR 100 000 per year) and SAM (1 FTE per year). The details of allocations per agency are provided in
Table 11.
Table 10. Pending resource needs per legislative proposal (operational costs in EUR 1 000)
FTEs
Activity
2025
2026
2027
2028
Operational costs
2025
2026
2027
2028
TA CA TA CA TA CA TA CA
Already proposed by the Commission (but without resources)
CLP regulation
Directive on packaging and packaging waste
Directive on end-of life-vehicles
Toy safety directive
3
1
1
2
2
0
0
0
3
1
1
2
2
0
0
0
3
1
1
2
2
0
0
0
3
0
1
2
2
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Proposed by the Commission as part of the package on one substance, one assessment
Directive on reattribution
RoHS directive
Regulation on reattribution
POPs regulation
Medical devices regulation
EEA founding regulation
General Food Law
Regulation on chemicals data
Common data platform
3
3
1
1
0
0
0
10
5
0
0
0
0
0
0
0
18
16
4
4
2
2
0
0
0
12
5
3
3
0
0
0
0
0
20
16
4
4
2
2
0
0
0
12
5
3
3
0
0
0
0
0
20
16
4
4
2
2
0
0
0
12
5
3
3
0
0
0
0
0
8
4
66
66
35
35
0
0
0
33
33
50
50
0
0
0
33
33
50
50
0
0
0
33
33
50
50
0
0
0
950 6 792 8 657 7 080
950 3 442 4 077 1 300
31
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2795275_0033.png
Information Platform for Chemical Monitoring
Information on regulatory processes on chemicals
Repository of reference values
Information on the obligations under Union acts
on chemicals
Environmental sustainability related data on
chemicals
Data generation mechanism
Mechanism for notification of studies & database
for study notifications
Early warning and action system for emerging
chemical risks and framework of indicators
Observatory for specific chemicals with potential
contribution to emerging chemical risks
Planned to be proposed by the Commission
Proposal for regulation on ECHA
Cooperation of ECHA with other agencies
Scientific opinions on OELs
Information on the obligations under Union acts
on chemicals
Observatory for specific chemicals with potential
contribution to emerging chemical risks
REACH regulation
Cosmetic products regulation
Scientific advice of SCHEER on non-chemical
topics
SUM
1
0
1
0
0
1
1
1
0
0
0
0
0
0
0
2
0
0
2
0
1
0
1
1
1
1
0
1
0
0
0
0
1
2
0
0
2
0
1
0
1
1
1
1
0
1
0
0
0
0
1
2
0
0
2
0
1
0
1
1
1
1
0
1
0
0
0
0
1
2
0
0
0
0
0
0
0
200
0
650
0
0
380
0
650
0
0
230
0
200
0
0
0 1 000 3 000 5 000
0
0
0
1200
300
0
400
150
0
200
150
0
5
0
3
2
0
0
7
1
34
6
0
2
1
3
0
0
0
26
5
0
3
2
0
0
7
1
38
6
0
2
1
3
0
0
0
31
5
0
3
2
0
0
7
1
38
6
0
2
1
3
0
0
0
31
5
0
3
2
0
0
7
1
37
6
0
2
1
3
0
0
0
0 1 260 1 260 1 260
0
0
0
0
0
0
0
0
200
630
430
0
300
0
0
200
630
430
0
300
0
0
200
630
430
0
300
0
19 1 051 8 435 10 300 8 723
Table 11. Pending resource needs per agency (operational costs in EUR 1 000)
FTEs
Agency / Service
ECHA
EEA
EFSA
EMA
EU-OSHA
JRC
SAM
SUM
2025
TA CA
30 16
3
2
0
5
0
3
0
0
0
0
1
0
34 26
2026
TA
CA
34
21
3
2
0
5
0
3
0
0
0
0
1
0
38
31
2027
TA
CA
34
21
3
2
0
5
0
3
0
0
0
0
1
0
38
31
2028
TA
CA
33
15
3
0
0
2
0
2
0
0
0
0
1
0
37
19
2025
101
0
670
100
0
180
0
1 051
Operational costs
2026
2027
6 719
766
670
100
0
180
0
8 435
8 666
684
670
100
0
180
0
10 300
2028
7 823
400
500
0
0
0
0
8 723
Overall resources saved
It must be noted that some activities that have been reattributed were performed also before the reattribution
and resources were used for those activities (see Table 12 below). The resources used for rapid risk assessment
for serious cross-border threats, the operation of databases under the SEVESO directive and implementation
work on chemicals under surface and ground water legislation consisted of
3.6 FTEs/year of regular staff, 7
FTEs per year of intramurous contractors or interim staff (ca. EUR 460 000 per year) and operational
budget of EUR 127 000 per year.
These resources will be saved at the institution that has performed the tasks
so far.
Table 12. Resource use for technical and scientific work before it was (re-)attributed to EU Agencies
Regulation on serious cross-border
threats to health
Total ca. 0.6 FTE/year + EUR 48 000/year: DG SANTE SCHEER secretariat 0.6 FTE (ca.
20% of SCHEER secretariat work), EUR 48 000 /year for indemnities, travel,
e.g.
costs for
members of the committee
32
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2795275_0034.png
Commission implementing decision
(EU) 2022/1979 under the SEVESO
Directive (2012/18/EU)
Water legislation (surface and
ground)
Total 4 FTEs: DG JRC 1 FTE (core staff) + 3 FTEs external contractors
Total: ca. 6.0 FTEs and EUR 79 200/year:
EQSD: DG JRC 1 FTE /year (core staff) + contracting out for EUR 232 030 per year (=
3.5 FTEs), DG ENV contracting out for EUR 100 000 every 6 years for impact assessment
(= ca. 0.25 FTEs/year). In addition, 1/3
rd
of the SCHEER Committee capacity is dedicated
to water legislation (17 committee members + external experts); DG SANTE = 1 FTE
(core staff) and EUR 79 200 EUR per year (30% of 3 FTEs - the secretariat to SCHEER.
GWD: DG ENV contracting out EUR 10 560/year to get support to voluntary watchlist
(=0.16 FTEs)
3.6 FTEs / year of regular staff; 7 FTEs / year of intramurous contractors or interim
staff (ca. EUR 460 000/ year); Operational costs of ca. EUR 127 000 per year
SUM
Some tasks that are still to be (re-)attributed via the upcoming proposals are being currently performed and the
resources are allocated to them (see Table 13 below). The resources currently used for the RoHS directive,
POPs regulation, medical devices regulation, operation of IPCHEM, EUCLEF and observatory for
nanomaterials, for scientific opinions on OELs, end-of-life vehicle directive, cosmetics regulation and toy
safety directive amount to 12.8 FTEs per year of regular staff, 10.9 FTEs of intramurous contractors or interim
staff (705 K€ per year) and an operational budget of EUR 2 023 000 – EUR 2 423 000 /year. As these tasks
will be reattributed or formalised, the current resources used for these tasks will not be needed and will be
saved at the institution that performs or finances the tasks today. Therefore, the
total net increase in the
resources is lower than indicated in the Table 10, and for the tasks to be still reattributed accounts for
32 – 45 FTEs per year
and an operational budget of up to EUR 8 277 000 per year.
Table 13. Current resource use for technical and scientific work that is to be (re-)attributed to EU Agencies
RoHS directive
Total ca. 2.74 FTEs/year: EUR 145 000 annually (on average) for outsourcing the review of
exemptions (= ca. 2.2 FTEs/year) + a contract of EUR 180 000 on average each 5 years for
reviewing restrictions (= 0.54 FTE/year). (In addition, DG ENV ca. 1.5 FTE/year (for overall
RoHS implementation) whose work will remain)
Total ca. 1.5 FTEs/year: EUR 300 000 for consultants every 3 years (=1.5 FTE/year). (In
addition, DG ENV ca. 0.5 FTE/year (implementing the review of Annexes IV and V) whose
work will remain)
Total ca. 0.3 FTE/year + EUR 24 000/year: DG SANTE SCHEER secretariat 0.3 FTE (ca. 10%
of SCHEER secretariat work), EUR 24 000/year for indemnities, travel,
e.g.
costs for members
of the committee. (In addition, DG SANTE (policy unit) 0.1 FTE/year whose work will remain).
Total 4.5 FTEs/year: DG JRC staff 2.5 FTEs/year + IT experts intramurous 2 FTEs/year (EUR
130 000 per year)
ECHA already operates (P)ACT for REACH, CLP and POPs processes. EFSA already operates
OpenEFSA which has similar level of information as PACT. Resources for the operation and
continuous provision of information are to be absorbed by the Agencies.
ECHA already operates EUCLEF and this is financed through the contribution agreement
between DG GROW and ECHA: Total ca. EUR 1.0 – 1.4 million annually, with no posts.
ECHA runs the service through the employment of 4 interim staff members (ca. EUR 270
000/year) and via contractors: communication activities and external helpdesk ca. EUR 60
000/year, IT costs EUR 200 000/year, data costs EUR 430 000/year.
ECHA already operates the EU Observatory on Nanomaterials and this is financed via a
contribution agreement between DG GROW and ECHA: Total of ca. EUR 700 000 per year
including the 3 posts per year: 3 CAs/year (ca. EUR 270 000/year) and operational costs of ca.
EUR 430 000/year.
Total 4 FTEs/year and operational budget of ca. EUR 575 000/year: DG EMPL Service Level
Agreement with ECHA for assessment of 5 substances annually – in total EUR 975 000 that
includes 4 CA posts.
Total ca. 0.36 FTE/year for assessment of exemptions: a contract of EUR 60 000 every 2.5 years
for reviewing exemptions (= ca. 0.36 FTE annually). (In addition, DGENV ca. 0.1 FTE dedicated
to the work on hazardous substances whose work will remain).
Total ca. 3 FTEs/year + full SCCS membership + EUR 240 000/year: DG SANTE 3 FTEs for the
secretariat of SCCS + 14 members of SCCS and 4 external experts + ca. EUR 240 000 /year for
reimbursement of members (at peak up to EUR 340 000/year). (In addition, DG GROW ca. 1
FTE for overall implementation of the related provisions whose work will remain)
Total ca. 0.3 FTEs/year + EUR 24 000/year: DG SANTE for SCHEER secretariat ca. 0.3 FTE
(ca. 10% of SCHEER secretariat work) + EUR 24 000/year for reimbursements of SCHEER
POPs regulation
Medical devices regulation
IPCHEM
Information on regulatory
processes on chemicals
Information on the
obligations under Union acts
on chemicals
Observatory for specific
chemicals with potential
contribution to emerging
chemical risks
Scientific opinions on OELs
End-of-life vehicle directive
Cosmetic products regulation
Toy safety directive
33
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2795275_0035.png
SUM
members (10% of SCHEER work). (In addition, DG GROW ca. 1 FTE/year for overall
implementation of the related provisions) whose work will remain).
12.8 FTEs/year regular staff; 10.9 FTEs/year interim staff + contracted staff; Operational
budget: EUR 2 023 000 – 2 423 000 per year
10.3
Overall impacts on ECHA
Impact on ECHA’s resources
The proposals made by the Commission so far have already proposed to strengthen ECHA in the long term by
29 FTEs (see Table 14). An additional 48 FTEs are necessary in the long term to deal with the envisaged tasks
that were already proposed by the Commission but without allocation of resources or are still to be proposed
(see Table 15). Although the required reinforcement of ECHA seems significant, the allocation of 11 FTEs out
of 48 will be de facto a regularisation of resources that already exist in ECHA via administrative agreements
(4 FTEs for worker protection legislation and 3 FTEs for operation of EUON) or via a service level agreement
(4 interim employees for operation of EUCLEF). In addition, the allocation of some additional 11 FTEs is a
reattribution from other sources, mainly from contracting out the support (2.7 FTEs for RoHS directive, 1.5
FTEs for POPs regulation, 0.3 FTEs for medical devices, 3.5 FTEs for IPCHEM, 3 FTEs for cosmetics
regulation, 0.3 FTEs for toy safety directive and 0.36 FTEs for end-of-life vehicle directive).
Table 14. Resource already allocated to or proposed to be allocated to ECHA (operational costs in EUR 1 000)
Activity
Drinking water directive
Regulation on serious cross-border threats to health
European Partnership for the Assessment of Risks
from Chemicals
Batteries regulation
Industrial emissions directive
Water legislation
SUM
FTEs
2024
2025
2026
2027
TA CA TA CA TA CA TA CA
3
2
6
3
7
3
8
3
0
0
0
0
0
0
0
0
0
2
0
2
0
2
0
2
2
3
7
15
1
0
4
9
2
3
7
18
1
0
4
10
2
3
7
19
1
0
4
10
2
3
7
20
0
0
4
9
Operational costs
2024 2025 2026 2027
510
0
0
520
0
0
530
0
0
540
0
0
158
158
25
25
0
0
0
0
673
686
702
718
1 341 1 364 1 257 1 283
Table 15. ECHA pending resource needs per legislative proposal (operational costs in EUR 1 000)
FTEs
2025
2026
2027
2028
TA CA TA CA TA CA TA CA
Already proposed by the Commission (but without resources)
CLP Regulation
3
2
3
2
3
2
3
2
Directive on packaging and packaging waste
1
0
1
0
1
0
0
0
Directive on end-of life-vehicles
1
0
1
0
1
0
1
0
Toys safety directive
2
0
2
0
2
0
2
0
Proposed by the Commission as part of the package on one substance, one assessment
Activity
Directive on reattribution of tasks
RoHS Directive
Regulation on reattribution of tasks
POPs regulation
Medical devices regulation
Regulation on chemicals data
Common data platform
Information Platform for Chemical Monitoring
Information on regulatory processes on chemicals
Repository of reference values
Information on the obligations under Union acts
on chemicals
Environmental sustainability related data on
chemicals
Data generation mechanism
Mechanism for notification of studies & database
for study notifications
3
3
1
1
0
7
4
0
0
1
0
0
1
1
0
0
0
0
0
8
6
0
0
0
0
0
0
2
4
4
2
2
0
9
4
1
0
1
0
1
1
1
3
3
0
0
0
10
6
1
0
0
0
0
1
2
4
4
2
2
0
9
4
1
0
1
0
1
1
1
3
3
0
0
0
10
6
1
0
0
0
0
1
2
4
4
2
2
0
9
4
1
0
1
0
1
1
1
3
3
0
0
0
4
0
1
0
0
0
0
1
2
2025
Operational costs
2026 2027 2028
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
66
33
33
33
66
33
33
33
35
50
50
50
35
50
50
50
0
0
0
0
0 5 076 7 023 6 180
0 2 226 2 793
600
0
0
180
180
0
0
0
0
0
650
650
200
0
0
0
0
0
0
0
0
0 1 000 3 000 5 000
0 1 200
400
200
34
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2795275_0036.png
Early warning and action system for emerging
chemical risks and framework of indicators
Observatory for specific chemicals with potential
contribution to emerging chemical risks
Planned to be proposed by the Commission
Proposal for regulation on ECHA
ECHA’s cooperation with other agencies
Scientific opinions on OELs
EUCLEF
EU Observatory for Nanomaterials
REACH regulation
Cosmetic products regulation
SUM
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
5
0
3
2
0
0
7
30
6
0
2
1
3
0
0
16
5
0
3
2
0
0
7
34
6
0
2
1
3
0
0
21
5
0
3
2
0
0
7
34
6
0
2
1
3
0
0
21
5
0
3
2
0
0
7
33
6
0
2
1
3
0
0
15
0 1 260 1 260 1 260
0
0
0
0
0
200
200
200
0
630
630
630
0
430
430
430
0
0
0
0
0
300
300
300
101 6 719 8 666 7 823
Impact on ECHA’s expertise
As regards the expertise, ECHA has adequate expertise to address the majority of the new tasks. One exception
is the extension of the scope of assessments for waste stage under the batteries regulation, RoHS directive,
directive on end-of-life vehicles, packaging and packaging waste directive and POPs regulation, for which
ECHA will need to build or recruit additional expertise. ECHA will also need to acquire a new expertise as
regards water monitoring and derivation of water quality standards. ECHA will further need to build expertise
on the assessment of chemicals in materials coming in contract with drinking water, where assessment is
similar to food contact materials managed by EFSA.
Impact on ECHA’s committees
The estimated number of opinions per year from (re-)attribution of tasks is provided in the table below. It is
expected that
RAC
will have to deliver additional
80 opinions
per year as compared to today, while
SEAC
additional
50 opinions
per year. The increase in number of RAC opinions represents 72% increases as
compared today. It should be noted that the biggest increase comes from drinking water directive (50 opinions)
and from CLP regulation (13.5 opinions). The rest of legislations accounts for just 16.5 opinions. In order to
cope with increased workload, the RAC will require some adaptation aiming on increasing the number of
committee members (currently RAC membership is at 50% capacity), attractiveness of rapporteurship and
flexibility in structuring the work of the committee. This is envisaged to be tackled under the legislative
proposal for regulation on ECHA that is in preparation. The increase in number of SEAC opinion is moderate.
The SEAC in its current set up should be able to absorb the additional tasks, after some adaptations in similar
direction as for the RAC.
As regards the expertise, RAC has adequate expertise to address the majority of new tasks. The only exception
is the extension of scope of assessments for waste stage under the batteries regulation, RoHS directive,
directive on end-of-life vehicles and packaging and packaging waste directive, for which RAC will need to
build or recruit additional expertise. The SEAC expertise might need to be extended to cover the waste stage
of products and chemicals as well.
Table 16. Expected number of opinions from ECHA’s committees per year
Legislation / process
Drinking water directive
- Positive lists of substances
Batteries regulation
- Restriction
Water legislation
- Annex I Ground Water Directive
- Annex II Ground Water Directive
- Annex I EQS Directive
- Annex II EQS Directive
CLP Regulation
- COM request for new hazard classes
RoHS directive
- Restriction
- Request for exemption
RAC
50
1
1
1
4
1
13.5
1
3
SEAC
-
1
1
1
4
1
-
1
30
SCCS
-
-
-
-
-
-
-
-
-
35
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2795275_0037.png
POPs regulation
- Review of Annexes IV and V
Directive on end-of-life vehicle
- Review of existing exemptions
Cosmetic products regulation
- Opinions on substances
- Notes of guidance
Toy safety directive
- Assessments
SUM
-
-
-
-
4.2
79.7
2
5
-
-
4.2
50.2
-
-
11
1
-
12
10.4
Overall impacts on EEA
Impact on EEA’s resources
The proposals made by the Commission so far have already proposed to reinforce EEA in the long term by 11
FTEs (see Table 17). An additional 3 FTEs are necessary in the long term, topped up with 2 FTEs for short
term, to deal with the new envisaged tasks under the Regulation on chemicals data (see Table 18). The first
three years there will be a need of
5 FTEs (3 TA + 2 CA)
and operational budget of up to
EUR 766 000.
In
the fourth year and beyond, there will be a need of
3 FTEs (3 TA)
per year and an operational budget of
EUR
400 000
per year. It should be noted that the allocation of 1 FTE out of those required by EEA is a reattribution
of the existing resources used for operation of IPCHEM.
Table 17. Resource already allocated or proposed to EEA per legislative proposal (operational costs in EUR 1 000)
FTEs
Activity
2024
2025
2026
2027
TA CA TA CA TA CA TA CA
Regulation on serious cross-border threat to health
0
0
0
0
0
0
0
0
European Partnership for the Assessment of Risks
0
2
0
2
0
2
0
0
from Chemicals
Commission implementing decision 2022/1979
3
1
3
1
3
1
3
1
under SEVESO directive
E-PRTR regulation
2
0
2
0
2
0
2
0
Water legislation (chemicals related tasks)
3
0
3
0
3
0
3
0
SUM
8
3
8
3
8
3
8
1
Operational costs
2024 2025 2026 2027
0
289
330
170
130
919
0
289
70
70
80
509
0
289
70
30
80
469
0
0
70
30
80
180
Table 18. EEA pending resource needs per legislative proposal (operational costs in EUR 1 000)
Activity
Regulation on reattribution of tasks
POPs regulation
EEA founding regulation
Regulation on chemicals data
Common data platform
Information Platform for Chemical Monitoring
Information on regulatory processes on chemicals
Repository of reference values
Environmental sustainability related data on
chemicals
Early warning and action system for emerging
chemical risks and framework of indicators
SUM
2025
TA CA
0
0
0
0
0
0
3
2
1
2
1
0
0
0
0
0
0
0
1
3
0
2
FTEs
2026
2027
2028
TA CA TA CA TA CA
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3
2
3
2
3
0
1
2
1
2
1
0
1
0
1
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
3
0
2
1
3
0
2
1
3
0
0
Operational costs
2025 2026 2027 2028
0
0
0
0
0
0
0
0
0
0
0
0
0
0
766
266
200
0
0
0
300
766
0
0
0
684
334
200
0
0
0
150
684
0
0
0
400
200
50
0
0
0
150
400
The proposal for amendment of the POPs regulation via the regulation on (re-)attribution of tasks proposes to
reattribute the existing task performed by the Commission to EEA. EEA is expected to host the chemical
monitoring data in the environment of the POPs listed in Annex III, Part I and reported to ECHA under the
POPs regulation. It is expected that this data stream will be very small or even zero. Member States are required
to report those monitoring data only if they did not provide it to EEA under other reporting obligation.
However, such data in air are already reported to EEA and the proposal for revision of water legislation
36
 kom (2023) 0783 - Ingen titel
proposed that such data in water will be reported to EEA as well. As the potential hosting of data will be close
to zero, this work, if any, can be absorbed by EEA’s existing resources.
The proposal for amendment of the EEA founding regulation via the regulation on (re-)attribution of tasks
proposes to better specify existing tasks of EEA. EEA is given a mandate to develop assessment methodologies
related to chemicals within the mission of the agency and EEA is required to actively cooperate with other EU
Agencies as regards exchange of data and development of methodologies. There are no resource implications
as part of this work as the provisions formalise the activities performed, they prescribe the procedural steps to
follow and they enable the implementation of the legislative proposal on exchange of data. Any possible
resource needs stemming from these provisions can be absorbed by the existing resources of EEA or the
resources allocated for the common data platform.
The proposal for a regulation on chemicals data proposes to reattribute some of the existing tasks related to
IPCHEM from the Commission to EEA and to expand it. Under this task, the EEA will be requested to collect
and host human biomonitoring data and host all environmental occurrence data and indoor air quality data
currently held in IPCHEM. Additional resources are needed for these tasks.
The proposal for the regulation on chemicals data will further attribute a new task to EEA related to the
common data platform. EEA will be required to make the data it holds on chemicals available on a continuous
basis to the common data platform in appropriate formats. Moreover, it will be required to set formats and
controlled vocabularies in its area of competence so data can be easily shared, and it will be required to
cooperate with ECHA and other agencies in developing and operating the common data platform. Additional
resources are needed for these tasks.
The proposal will also attribute to EEA a new task on the early warning and action system and formalise the
existing task on the indicator framework which is already carried out by EEA. EEA will be required to compile
and collect annually the early warning signals into a report to be presented to the Commission, relevant
agencies and Member State authorities to consider whether any regulatory action is needed. EEA together with
ECHA will be required to continue operating and populating the indicator framework for chemicals policy.
Additional resources are needed for these tasks.
Finally, the proposal will require EEA to provide available data into the database on information on regulatory
processes on chemicals, the repository of reference values and the database on environmental sustainability
related data on chemicals and to cooperate with ECHA on the development of the databases and the repository.
No additional resources are needed for these tasks. EEA currently does not hold any relevant data for those
databases and the repository and the small contribution to the development of the tools is covered by the
resources for the common data platform.
Impact on EEA’s expertise
As regards expertise, EEA has the necessary expertise, experience and the network to perform the allocated
tasks.
Impact on EEA’s network
No significant impact on EEA’s network. The network might however be required to assist in the collection
of human biomonitoring data and early warning signals from activities of EEA member countries.
10.5
Overall impacts on EFSA
Impact on EFSA’s resources
The proposals made by the Commission so far have not proposed additional resources for EFSA (see Table
19). EFSA was significantly reinforced in 2019 (by some 106 FTEs per year and operational budget of EUR
17 800 000 per year) as part of the Regulation (EU) 2019/1381 on the transparency and sustainability of the
37
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EU risk assessment in the food chain
46
and the tasks attributed were small, thus could be covered by the existing
EFSA’s resources. Additional
2 FTEs
are necessary in the long term, topped up with
3 FTEs
for short term,
to deal with the envisaged tasks for EFSA under the proposal for regulation on chemicals data (see Table 20).
In total, the first three years there will be a need of
5 FTEs (5 CA)
per year and operational budget of up to
EUR 670 000
per year. In the fourth year and beyond, there will be a need of
2 FTE (1 CA)
per year and
operational budget of
EUR 500 000
per year.
Table 19. Resource already allocated or proposed to EFSA per legislative proposal (operational costs in EUR 1 000)
201FTEs
2024
2025
2026
2027
TA CA TA CA TA CA TA CA
Regulation on serious cross-border threat to health
0
0
0
0
0
0
0
0
European Partnership for the Assessment of Risks
0
0
0
0
0
0
0
0
from Chemicals
SUM
0
0
0
0
0
0
0
0
Activity
2024
0
0
0
Operational costs
2025 2026 2027
0
0
0
0
0
0
0
0
0
Table 20. EFSA pending resource needs per legislative proposal (operational costs in EUR 1 000)
Activity
CLP Regulation
Regulation on reattribution of tasks
General Food Law
Regulation on chemicals data
Common data platform
Information Platform for Chemical Monitoring
Information on regulatory processes on chemicals
Repository of reference values
Environmental sustainability related data on
chemicals
Data generation mechanism
Mechanism for notification of studies
Early warning and action system and framework
of indicators for chemicals
SUM
TA
0
0
0
0
0
0
0
0
0
0
0
0
0
FTEs
2025
2026
2027
2028
CA TA CA TA CA TA CA
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
5
0
5
0
5
0
2
5
0
5
0
5
0
2
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
5
0
0
0
0
0
0
0
5
0
0
0
0
0
0
0
5
0
0
0
0
0
0
0
2
2025
0
0
0
670
670
0
0
0
0
0
0
0
670
Operational costs
2026 2027 2028
0
0
0
670
670
0
0
0
0
0
0
0
670
0
0
0
670
670
0
0
0
0
0
0
0
670
0
0
0
500
500
0
0
0
0
0
0
0
500
The proposal for revision of the CLP regulation proposes to attribute a new task to EFSA. EFSA on the request
of the Commission is required to prepare a dossiers for harmonised classification of a substance. As hazard
assessment is the core task of the Authority and the requests are unlikely to be too numerous, this work can be
absorbed within the existing resources of the Authority.
The proposal for amendment of the general food law via the regulation on (re-)attribution of tasks proposes to
better specify the existing tasks of EFSA. EFSA will be required to actively cooperate with other EU Agencies
as regards exchange of data and development of methodologies. EFSA will be further required to engage more
in preventing or solving a divergent opinion with other EU Agencies. There are no resource implications of
these amendments. The provisions formalise the activities performed, they prescribe the procedural steps to
follow and they enable the implementation of the legislative proposal on exchange of data. Any possible
resource needs stemming from these provisions can be absorbed by the existing resources of EFSA.
The proposal for a regulation on chemicals data proposes to formalise existing tasks and to attribute new tasks
to EFSA.
•
EFSA will be required to make data on chemicals it holds available on a continuous basis to the
common data platform in appropriate formats. In addition, it will be required to set formats and
controlled vocabularies in its area of competence so data can be easily shared, and it will be required
46
Regulation (EU) of the European Parliament and of the Council of 20 June 2019 on the transparency and
sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No
1829/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283) and
Directive 2001/18/EC (OJ L 231 6.9.2019, p.1)
38
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•
•
•
•
•
•
•
to cooperate with ECHA and other agencies in developing and operating the common data platform.
For this, EFSA will need 5 FTEs during 3 years to launch the common data platform with all its
functionalities and data and then 2 FTEs from the 4
th
year and onwards to ensure adequate input,
operation and the further development of the common data platform and its underlying services.
EFSA will also be required to contribute to the operation of and provide data to IPCHEM. This is an
existing task of EFSA, so no additional resources are needed.
EFSA will furthermore be required to provide on a continuous basis information on the status of
regulatory processes into the database with information on regulatory processes on chemicals.. EFSA
already compiles such inform in the OpenEFSA database, which will be fed into the new database.
There is no need for additional resources for this work as the compilation of information is ongoing
and streamlining the information into the common data platform will be covered by the resources for
the common data platform.
EFSA will further be required to provide relevant information to the repository of reference values and
contribute to its development. EFSA already compiles reference values in its OpenFoodTox database,
which will be fed into the repository of reference values. There is no need for additional resources for
this activity as it already exists and streamlining it to the repository of reference values will be covered
by the resources for the common data platform.
EFSA will be also required to provide available data into the database on environmental sustainability
related data on chemicals. No additional resources are needed for this tasks, as EFSA currently does
not hold any relevant data for this database and the potential small contribution to the development of
the tools is covered by the resources for the common data platform.
EFSA will be required to cooperate with ECHA on the commissioning of scientific studies. EFSA
already commissions such studies under General Food Law and the additional resource needs for the
cooperation with ECHA in doing so should be absorbed by EFSA within the existing allocation of
resources.
EFSA will be required to provide input to the indicators framework and early warning and action
system. There is no need for additional resources for this activity, because EFSA already operates the
emerging risk exchange network (EREN) for the food sector and the output of that work will be fed
into the early warning and action system on chemicals.
Finally, EFSA will be required to ensure the compatibility of its system of study notifications
established under Article 32b of the General Food Law with the database of study notifications to be
set up by ECHA for remaining chemical legislation. The resources for this should be absorbed by the
resources available in EFSA for the operation of its system of notification of studies.
Impact on EFSA’s expertise
As regard expertise, EFSA has the necessary expertise and experience to perform the allocated tasks.
Impact on EFSA’s committees
No significant impact on EFSA committees. The rapporteurs of EFSA committees that derive reference values
might need to record the derived reference values and associated metadata into the repository of reference
values or structure this information in the related opinion for automatic processing.
10.6
Overall impacts on EMA
Impact on EMA’s resources
The proposals for legislation on medicinal products for human use proposed a significant strengthening of
EMA to deal with the new tasks proposed to be entrusted to EMA (see Table 21), with some of the tasks being
relevant for the proposals on reattribution of tasks and on chemicals data. However, additional
2 FTEs
are
necessary in the long term, topped up with
1 FTE
for short term, to deal with the envisaged tasks for EMA
under the proposal for regulation on chemicals data (see Table 22). In total, the first three year there will be a
need of
3 FTEs (3 CA)
per year and an operational budget of
EUR 100 000.
In the fourth year and beyond,
there will be a need of
2 FTEs (2 CA)
per year and
EUR 0
per year.
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Table 21. Resources already allocated or proposed to EMA per legislative proposal (operational costs in EUR 1 000)
Activity
Serious cross-border threat regulation
Legislation on medicinal products for human use
SUM
TA
0
37
37
2025
CA TA
0
0
0 52
0 52
FTEs
2026
2027
2028
CA TA CA TA CA
0
0
0
0
0
0 60
0 60
0
0 60
0 60
0
Operational costs
2025 2026 2027 2028
0
0
0
0
0
0
0
0
0
0
0
0
Table 22. EMA pending resource needs per legislative proposal (operational costs in EUR 1 000)
Activity
Regulation on chemicals data
Common data platform
Information Platform for Chemical Monitoring
Repository of reference values
Environmental sustainability related data on
chemicals
Early warning and action system and framework
of indicators
SUM
2025
TA CA
0
3
0
3
0
0
0
0
0
0
0
0
0
3
FTEs
2026
2027
2028
TA CA TA CA TA CA
0
3
0
3
0
2
0
3
0
3
0
2
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3
0
0
0
3
0
0
0
2
Operational costs
2025 2026 2027 2028
100
100
0
0
0
0
100
100
100
0
0
0
0
100
100
100
0
0
0
0
100
0
0
0
0
0
0
0
The proposal for a regulation on chemicals data proposes new tasks for EMA.
•
EMA will be required to make some of the data it receives after entry into force of this regulation
available on a continuous basis to ECHA for integration into the common data platform, it will be
required to set formats and controlled vocabularies in its area of competence so data can be easily
shared and it will be required to cooperate with ECHA and other agencies in developing and operating
the common data platform. EMA will need additional resources for these tasks.
EMA will be also required to provide occurrence data it holds to IPCHEM and provide cooperation to
ECHA in integration of such data in IPCHEM. However, EMA currently does not hold any data
relevant to IPCHEM, therefore, no resources are required for this activity. Any cooperation required
is covered by the resources for the common data platform.
EMA will be required to cooperate with ECHA on the operation of the repository of reference values
and provide on a continuous basis specific reference value it derives (i.e. predicted no effect
concentration derived as part of the environmental risk assessment) to the repository. The cooperation
with ECHA and provision of data is covered by the resources provided for the common data platform.
EMA will be required to provide environmental sustainability related data on chemicals to ECHA and
cooperate with ECHA to enable integration of the data into a database. EMA however does not
currently host any such data, therefore, no additional resources are required for this for EMA. Any
cooperation with ECHA on setting up the database is covered by the resources for the common data
platform.
EMA will be required to provide available early warning signals from their areas of responsibility to
EEA. EMA will require no additional resources for this task, as the cooperation is covered by the
resources for the common data platform and potential provision of data is a small task that can be
absorbed by EMA’s existing resources.
Finally, EMA will be required to cooperate with EEA and other agencies on the establishment,
operation and maintenance of the framework of indicators. EMA will require no additional resources
for this task, as the cooperation is covered by the resources for the common data platform and potential
provision of data is a small task that can be absorbed by EMA’s existing resources.
•
•
•
•
•
Impact on EMA’s expertise
As regards expertise, EMA has the necessary expertise and experience to perform the allocated tasks.
Impact on EMA’s committees
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No significant impact on EMA committees. The rapporteurs of EMA committees that derive reference values
might need to record the derived reference values and associated metadata into the repository of reference
values or structure this information in the relevant opinion for automatic processing.
10.7
Overall impacts on EU-OSHA
Impact on EU-OSHA’s resources
No additional resources are necessary for EU-OSHA to deal with the envisaged tasks under the proposal for
regulation on chemicals data (see Table 23).
Table 23. EU-OSHA pending resource needs per legislative proposal (operational costs in EUR 1 000)
Activity
Regulation on chemicals data
Common data platform
Information Platform for Chemical Monitoring
Information on regulatory processes on chemicals
Repository of reference values
Environmental sustainability related data on
chemicals
Early warning and action system and framework
of indicators
SUM
FTEs
2025
2026
2027
2028
TA CA TA CA TA CA TA CA
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2025
0
0
0
0
0
0
0
0
Operational costs
2026 2027 2028
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
The proposal for a regulation on chemicals data requires EU-OSHA to provide data to ECHA for the
integration into the common data platform and to cooperate with ECHA in developing and operating the
common data platform. It also requires EU-OSHA to provide relevant data to the information platform for
chemical monitoring, database on regulatory processes on chemicals, repository of reference values, database
of environmental sustainability related data on chemicals and to early warning and action system and
framework of indicators. EU-OSHA, however, does not currently systematically collect or host any data
relevant for the common data platform and its building blocks. EU-OSHA’s role is therefore mainly to
contribute with their inputs and suggestions to the development of the common data platform and its building
blocks. EU-OSHA can be seen as a ‘privileged’ user of the system who can provide input to the development
and operation to ensure that the systems are developed in such way that they suit also the needs of EU-OSHA.
No additional resources are needed for these tasks, as they can be covered by the existing resources.
Impact on EU-OSHA’s expertise
As regards expertise, EU-OSHA has the necessary expertise and experience to perform the allocated tasks.
Impact on EU-OSHA’s committees
There is no impact on EU-OSHA’s advisory groups or the management board.
41
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A
NNEX
I: M
ISSION
,
CORE ACTIVITIES
,
COMPETENCES AND SCIENTIFIC
BODIES OF THE
A
GENCIES
1. E
UROPEAN
F
OOD
S
AFETY
A
UTHORITY
The European Food Safety Authority (EFSA) is an integral part of the EU’s food safety system. As outlined
in its Founding Regulation (Regulation (EC) No 178/2002), the Authority’s mission is to contribute to the
safety of the EU food and feed chain, mainly by:
•
Providing EU risk managers with independent, up-to-date and fit-for-purpose scientific advice on
questions related to food and feed safety, animal health and welfare, plant health, nutrition and
environmental issues specific to the above
47
within the two main streams as described below:
o
o
•
•
•
•
•
•
Generic risk assessments
in the following areas of work: Plant health, Animal health, Animal
welfare, Chemicals Hazards, Biological hazards, Zoonoses-TSE-Antimicrobial resistance
monitoring and Nutrition
Regulated products
in the following areas of work: Novel foods, Feed additives, Food
ingredients, Food contact materials, Genetically modified food/feed and Pesticides;
Providing EU risk managers with scientific and technical support in areas falling under EFSA’s
competence
Communicating to the public on matters falling under EFSA’s competence and in particular on EFSA’s
outputs and the information on which they are based;
Developing and applying uniform methodologies for fit-for-purpose scientific advice on questions
related to food safety;
Collecting and analysing data to allow the identification, characterisation and monitoring of current
risks that have a direct or indirect impact on food safety;
Cooperating with Member States, institutional partners and other interested parties/stakeholders
48
in
the EU to promote coherent advice and increase trust in the EU food safety system;
Identifying emerging risks to food safety and contributing to a high level of protection of human life
and health.
Risk Assessment in the areas within the EFSA’s remit: Chemicals, micro-organisms, environment,
plant health and plant protection, animal health and animal welfare, occupational;
Efficacy Assessment, particularly in the area of feed additives;
Chemistry, including chemical characterisation, and molecular characterisation;
Animal sciences: Animal nutrition, Animal production, Animal pathology, Animal welfare;
Environmental sciences;
Food Sciences;
Human sciences: Human medicine, nutrition;
Plant sciences: plant pests, plant health, plant products, biodiversity, food security;
Hazard Assessment: Human and veterinary toxicology, ecotoxicology and environmental fate;
EFSA’s specific competences include:
•
•
•
•
•
•
•
•
•
47
The phrase ‘food safety’ is used throughout the document as shorthand for ‘food and feed safety, animal health and welfare, plant
health, nutrition and environmental issues specific to the above’
48
As defined in EFSA’s founding regulation (Regulation (EC) No 178/2002), Article 3(13)
42
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•
•
•
•
Human exposure assessment, including dietary, non-dietary and cumulative;
Data collection, data and information management: Zoonoses, Foodborne diseases, Food/Feed
Contaminants, Pesticides and Veterinary medicine residues, Systematic literature reviews;
Risk assessment methodological development;
Identification of emerging risks, Foresight and Horizon scanning, Early Warning systems.
The scientific work related to risk assessment is entrusted to ten EFSA Scientific Panels and the Scientific
Committee:
•
Panel on Additives and Products or Substances used in Animal Feed (FEEDAP).
Provides scientific
advice on the safety and/or efficacy of additives and products or substances used in animal feed. The
Panel evaluates their safety and/or efficacy for the target species, the user, the consumer of products
of animal origin and the environment. It also looks at the efficacy of biological and chemical
products/substances intended for deliberate use in animal feed.
Panel on Animal Health and Welfare (AHAW).
Provides scientific advice on all aspects of animal
diseases and animal welfare. Its work chiefly concerns food producing animals, including fish.
Panel on Biological Hazards (BIOHAZ).
Provides scientific advice on biological hazards in relation
to food safety and food-borne diseases. This covers animal diseases transmissible to humans;
transmissible spongiform encephalopathies; food microbiology; food hygiene and associated waste
management issues.
Panel on Food Contact Materials, Enzymes and Processing Aids (CEP).
Evaluates the safety of
chemical substances added to food or used in food packaging, and related processes.
Panel on Contaminants in the Food Chain (CONTAM).
Provides scientific advice on contaminants in
the food chain and undesirable substances such as natural toxicants, mycotoxins and residues of
unauthorised substances.
Panel on Food Additives and Flavourings (FAF).
Evaluates the safety of chemical substances added
to food and consumer exposure to them. The Panel's work mainly concerns substances evaluated by
EFSA before their use can be authorised in the EU.
Panel on Genetically Modified Organisms (GMO).
Provides independent scientific advice on food and
feed safety, environmental risk assessment and molecular characterisation/plant science. Its work
chiefly concerns genetically-modified plants, micro-organisms and animals.
Panel on Nutrition, Novel Foods and Food Allergens (NDA).
Deals with questions related to human
nutrition, novel foods, nutrient sources, foods for special groups such as infant formulae, health claims
on food products, dietary reference values, and food allergies.
Panel on Plant Health (PLH).
Provides independent scientific advice on the risk posed by plant pests
which can cause harm to plants, plant products or biodiversity in the EU. The Panel reviews and
assesses those risks with regard to the safety and security of the food chain.
Panel on Plant Protection Products and their Residues (PPR).
Provides scientific advice on the risk
assessment of pesticides for operators, workers, consumers and the environment. The Panel develops
and reviews guidance documents on the risk assessment of pesticides. This work supports the
evaluation of active substances used in pesticides, which is carried out Rapporteur Member States and
peer reviewed by EFSA staff.
Scientific Committee.
Develops harmonised risk assessment methodologies on scientific matters of a
horizontal nature in the fields within EFSA's remit where EU-wide approaches are not already defined.
It provides general co-ordination to ensure consistency in the scientific opinions prepared by EFSA's
Scientific Panels. It also provides strategic scientific advice to EFSA’s management.
•
•
•
•
•
•
•
•
•
•
43
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2. E
UROPEAN
C
HEMICALS
A
GENCY
The European Chemicals Agency (ECHA) implements the EU’s chemicals legislation to protect human health
and the environment. ECHA’s core competence, is to deliver scientifically sound and consistent regulatory
outcomes that meet EU chemicals policy objectives in a transparent, professional, independent and efficient
manner.
ECHA’s scientific competences cover the areas of chemical hazard and risk assessment, identifying the most
effective risk management option(s), assessing alternative substances and socio-economic consequences of
risk management decisions. ECHA covers the area of hazard assessment for industrial chemicals, pesticides
and biocides; risk assessment of industrial chemicals; use and exposure to chemicals other than food and
medicines.
ECHA’s specific competences include:
•
•
•
•
•
•
•
•
•
•
•
Chemistry, including substance identification and phys chem properties
Hazard assessment – toxicology, ecotoxicology and environmental fate
Derivation of limit values
Alternative methods to animal testing (for example, QSARs)
Exposure and risk assessment
Risk management
Data and information management in relation to chemicals management
Consensus building and delivery of scientific opinions
Delivery of regulatory decisions
Support duty holders with regulatory obligations
ECHA has four committees and the enforcement forum:
Committee for Risk Assessment. Prepares the opinions of ECHA related to the hazards and risks of
substances to human health and the environment for the harmonised classification under CLP, for
restrictions and authorisations under REACH and for the occupational exposure limits under worker
protection legislation.
Committee for Socio-Economic Analysis. Prepares the opinions of ECHA related to the socio-
economic impact of possible legislative actions on chemicals in restriction and authorisation processes
under REACH. The final decisions are taken by the European Commission.
Member State Committee. The Member State Committee (MSC) participates in several REACH
processes such as evaluation and authorisation. The MSC is responsible for resolving divergences of
opinions among Member States and on proposals for the identification of Substances of Very High
Concern (SVHCs). The Committee provides opinions on ECHA's draft recommendation for the
authorisation list (Annex XIV) and draft Community Rolling Action Plan (CoRAP) for the substance
evaluation process. If an agreement is not reached within the MSC, the matter is referred to the
European Commission for decision-making.
Biocidal Product Committee. Prepares the opinions of ECHA related to the following processes under
biocidal product regulation:
o
Applications for approval and renewal of approval of active substances
o
Review of approval of active substances
o
Applications for inclusion in Annex I of active substances meeting the conditions laid down
in Article 28 and review of the inclusion of such active substances in Annex I
o
Identification of active substances which are candidates for substitution
o
Applications for Union authorisation of biocidal products and for renewal, cancellation and
amendments of Union authorisations, except where the applications are for administrative
changes
o
Scientific and technical matters concerning mutual recognition in accordance with Article 38
44
•
•
•
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2795275_0046.png
o
At the request of the Commission or of the Member States, the BPC is also responsible for
preparing an opinion on any other questions that may arise from the operation of the BPR
relating to risks to human or animal health or the environment, or to technical guidance.
•
Enforcement Forum. A network of authorities responsible for the enforcement of the REACH, CLP,
and PIC, POP and Biocidal Product regulations in the EU, Norway, Iceland and Liechtenstein. It
coordinates enforcement strategies, proposes, coordinates and evaluates harmonised enforcement
projects and joint inspections, it provides advice on enforceability of regulatory measures and provides
harmonised practices and training.
45
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3. E
UROPEAN
M
EDICINES
A
GENCY
The European Medicine Agency (EMA) is responsible for coordinating the existing scientific resources put at
its disposal by Member States for the evaluation, supervision and monitoring of medicinal products.
The Agency’s specific competences include:
•
•
•
•
providing scientific advice to medicine developers;
evaluating applications for orphan designation (medicines for rare diseases);
assessing paediatric investigation plans, which determine the studies that medicines developers must
carry out in children;
coordinating the scientific evaluation of applications for centralised marketing authorisations of
human and veterinary medicinal products in the European Union, based on an evaluation of their
quality, safety and efficacy;
advising on maximum allowed concentrations for residues of veterinary medicinal products or
biocidal products for use in animal husbandry which may be accepted in foodstuffs of animal origin
(MRLs)
coordinating inspection for the verification of compliance with the principles of good manufacturing
practice, good laboratory practice, good clinical practice and pharmacovigilance obligations;
publishing information on authorised medicinal products and potential adverse reactions;
coordinating pharmacovigilance monitoring systems on all authorised medicines in the EU;
assisting EU countries with communication to healthcare professionals and patients;
creating and maintaining a web-portal on medicinal products and their approved uses accessible to
the general public; and ensuring that it is updated, and managed independently of pharmaceutical
companies; the database facilitates the search for information already authorised for package leaflets;
development of scientific guidelines on the requirements for quality, safety and efficacy testing of
medicines;
promotion of alternative methods to animal testing;
environmental risk assessment (ERA) of active pharmaceutical ingredients;
supporting the development of new medicines and treatment approaches to respond to antimicrobial
resistance; promoting responsible use of existing antibiotics; collecting antimicrobial consumption
data to guide policy and research;
managing shortages medicines and medical devices and supporting medicine development, approval
and monitoring in preparation for and during public health emergencies.
•
•
•
•
•
•
•
•
•
•
•
EMA has seven scientific committees and a number of working parties and related groups which conduct the
scientific work of the Agency:
•
•
•
•
Committee for Medicinal Products for Human Use (CHMP). Responsible for preparing the opinions
of the Agency on any question relating to the evaluation of medicinal products for human use;
Pharmacovigilance Risk Assessment Committee (PRAC). Responsible for assessing and monitoring
the safety of human medicines.
Committee for Veterinary Medicinal Products (CVMP). Responsible for preparing the opinion of the
Agency on any question relating to the evaluation of medicinal products for veterinary use.
Committee for Orphan Medicinal Products (COMP). Responsible for recommending orphan
designations of medicines for rare diseases.
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•
Committee on Herbal Medicinal Products (HMPC). Responsible for compiling and assessing
scientific data on the recommended use and safe conditions of use of herbal substances, preparations
and combinations, to support the harmonisation of the European market.
Committee for Advanced Therapies (CAT). Responsible for assessing the quality, safety and
efficacy of advanced therapy medicinal products (ATMPs) and following scientific developments in
the field.
Paediatric Committee (PDCO). Responsible for activities on medicines for children and to support
the development of such medicines in the European Union by providing scientific expertise and
defining paediatric needs.
•
•
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4. E
UROPEAN
E
NVIRONMENT
A
GENCY
The European Environment Agency (EEA) is mandated to provide the Community and the Member States
with the objective, reliable and comparable information at European level and with the necessary technical and
scientific support, enabling them to take the requisite measures to protect the environment, to assess the results
of such measures and to ensure that the public is properly informed about the state of the environment. For
these purposes, the Agency:
•
•
maintains the network of national information networks, the national focal points and the topic centres;
collects, processes and analyses data used in the implementation of EU environmental policy including
chemicals emission data to water and air, and chemical monitoring data in surface waters, groundwater
and ambient air;
assists the monitoring of environmental measures through appropriate support for reporting
requirements;
records, collates and assesses data on the state of the environment; draws up expert reports on the
quality, sensitivity and pressures on the environment within the territory of the Community, provides
uniform assessment criteria for environmental data to be applied in all Member States; develops further
and maintain a reference centre of information on the environment;
helps ensuring that environmental data at European level are comparable and encourages improved
harmonisation of methods of measurement;
promotes the incorporation of European environmental information into international environment
monitoring programmes such as those established by the United Nations and its specialised agencies;
stimulates the development and application of environmental forecasting techniques so that adequate
preventive measures can be taken in good time;
stimulates the development of methods of assessing the cost of damage to the environment and the
costs of environmental preventive, protection and restoration policies;
stimulates the exchange of information on the best technologies available for preventing or reducing
damage to the environment;
ensures the broad dissemination of reliable and comparable environmental information, in particular
on the state of the environment, to the general public and, to this end, to promote the use of new
telematics technology for this purpose;
supports the Commission in the process of exchange of information on the development of
environmental assessment methodologies and best practice;
assists the Commission in the diffusion of information on the results of relevant environmental
research and in a form which can best assist policy development
•
•
•
•
•
•
•
•
•
•
EEA’s specific competences include:
•
•
•
collecting, processing and analysis of environmental data at European level;
providing and maintaining an efficient reporting infrastructure for data flows and supporting members
countries in reporting data;
Collecting, maintaining and making publicly available datasets on emissions of pollutants to air and
water, and on pollutants in ambient air, surface waters, groundwater and drinking water. Collecting
data reported by companies on the production, import, export, destruction and feedstock use of F-gases
in the EU assessing the state of the European environment, and climate, including assessments of the
overall impact of chemical pollution on the environment and human health in Europe;
Communicating environmental and climate change information to citizens;
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•
Producing evidence-based knowledge to support policy implementation and development of new
initiatives to accelerate and scale up the transition to sustainability. Delivering targeted inputs to
inform policy and public discussions, by organising and communicating knowledge on responses,
including innovative solutions to societal challenges.
EEA coordinates at EU level the European Environment Information and Observation Network (EIONET). It
consists of the EEA’s member countries (27 EU Member States plus Iceland, Liechtenstein, Norway,
Switzerland and Türkiye) and cooperating countries (Albania, Bosnia and Herzegovina, North Macedonia,
Montenegro, Serbia and Kosovo). The network brings together around 2000 experts from more than 400
national institutions that have expertise in environmental issues. The EIONET network has the following roles
and functions:
•
National Focal points
– nominated and funded by countries to act as primary links between the EEA
and their country. NFPs organise and develop their country’s Eionet network, as well as facilitate and
coordinate contacts, requests and information delivery at national and EU levels.
National Data Flow Coordination
– ensures a coherent and coordinated overview of collecting,
collating and sharing data between the country and the EEA to respond efficiently to the needs of the
Agency's work programme.
EIONET groups
– work with the EEA and European Topic Centres to assess Europe’s environment
and climate, and any related impacts on health and ecosystems. Currently there are 13 Eionet Groups,
several of them supported by Thematic Groups:
o
o
o
o
o
o
o
o
o
o
o
o
o
•
Biodiversity and ecosystems - integration of knowledge for policies
Biodiversity and ecosystems - cumulative pressures and solutions
Circular economy and resource use
Climate change impacts, vulnerability and adaptation
Climate change mitigation and energy systems
Communications
Data, technologies and digitalisation
Food systems
Foresight
Human health and the environment
Land systems
Mobility systems
State of the environment
•
•
European Topic Centres (ETC)
– are thematic expertise centres contracted and funded by the EEA
for tasks identified in the EEA-EIONET Strategy. These are designated by the EEA management board
following a European-wide competitive selection process. The topic centres support the EEA in the
processing and analysis of the data received from Member Countries. As of 2023, there are 7 topic
centres working with EEA and national EIONET partners:
o
o
o
o
o
o
o
ETC on Biodiversity and Ecosystems
ETC in Circular Economy and Resource Use
ETC on Climate Change Adaptation and LULUCF
ETC on Climate Change Mitigation
ETC on Data Integration and Digitalisation
ETC on Human Health and the Environment
ETC on Sustainability Transitions
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5. E
UROPEAN
A
GENCY FOR
S
AFETY AND
H
EALTH AT
W
ORK
The European Agency for Safety and Health at Work (EU-OSHA) provides the Union institutions and bodies,
the Member States, the social partners and other actors involved in the field of safety and health at work with
relevant technical, scientific and economic information and qualified expertise in the field of safety and health
at work in order to improve the working environment as regards the protection of the safety and health of
workers.
To that end, EU-OSHA enhances and disseminates knowledge, provides evidence and services for the purpose
of policy making, including research-based conclusions, and facilitates knowledge sharing among and between
Union and national actors.
The EU-OSHA does this by developing, gathering and providing reliable and relevant information, analysis and
tools to advance knowledge, raise awareness and exchange occupational safety and health (OSH) information
and good practice which will serve the needs of those involved in OSH. Concretely, the EU-OSHA:
•
collects and analyses technical, scientific and economic information on safety and health at work in
the Member States in order to:
o
o
o
•
identify risks and good practices as well as existing national priorities and programmes;
provide the necessary input to Union priorities and programmes; and
disseminate that information to the Union institutions and bodies, the Member States, the
social partners and other actors involved in the field of safety and health at work;
collects and analyses technical, scientific and economic information on research into safety and health
at work and on other research activities which involve aspects connected with safety and health at
work and disseminate the results of the research and research activities;
promotes and supports cooperation and exchange of information and experience amongst the Member
States in the field of safety and health at work, including information on training programmes;
organises conferences and seminars and exchanges of expertise from the Member States in the field
of safety and health at work;
supplies the Union institutions and bodies and the Member States with the objective technical,
scientific and economic information available and the qualified expertise they require to formulate and
implement judicious and effective policies designed to protect the safety and health of workers;
provides forums for exchange of experiences and information between the governments, the social
partners and other stakeholders at national level;
contributes, including through evidence-based information and analyses, to the implementation of
reforms and policies at national level;
collects and makes available information on safety and health matters from and to third countries and
international organisations;
provides technical, scientific and economic information on methods and tools for implementing
preventive activities, identify good practices and promote preventive actions, paying particular
attention to the specific problems of MSMEs and, with regard to good practices, focuses, in particular,
on practices which constitute practical tools to be used in drawing up an assessment of the risks to
safety and health at work, and identifying the measures to be taken to tackle those risks;
contributes to the development of Union strategies and action programmes relating to the protection
of safety and health at work,
establishes a strategy for relations with third countries and international organisations;
50
•
•
•
•
•
•
•
•
•
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•
carries out awareness raising and communication activities and campaigns on safety and health at work
issues.
EU-OSHA’s specific competences include:
•
Competence in occupational safety and health as regards the workplace management of dangerous
substances (this includes registered chemicals and process-generated substances and mixtures (e.g.
silica dust, welding fumes, diesel motor emissions or wood dust))
Development of tools for the management of dangerous substances at the workplace level and sectoral
workplace risk assessment tools (OiRA)
Collecting information on national tools and guidance and examples of good practice regarding the
management of dangerous substances at work.
Development of information and awareness-raising campaigns in the area of dangerous substances at
work
Collecting and analysing technical and scientific information in the area of dangerous substances at
work and related health problems and publishing the results
Development of surveys targeting exposures at workplaces, e.g. the Workers´ exposure survey on
cancer risk factors in Europe
Supporting the European Commission, for instance through the development of guidance in the area
of dangerous substances management and OSH
•
•
•
•
•
•
The EU-OSHA maintains a network that comprises the main components of the national information networks,
including the national employers’ and employees’ organisations and the national focal points.
•
Network of national
Focal Points and Member State tripartite networks:
in accordance with the
founding regulation of EU-OSHA, the national authorities or a national institution designated by the
Member State as a national focal point coordinates and transmits the information to be supplied at
national level to EU-OSHA within the framework of an agreement between each focal point and EU-
OSHA on the basis of the work programme adopted by EU-OSHA. The national authorities or national
institution shall consult the national employers' and employees' organisations and shall take into
account their point of view in accordance with national law or practice. The Member States regularly
inform EU OSHA of the main components of their national safety and health at work systems and
strategies. This network provides input to EU-OSHA’s work and the mechanism to disseminate
products and information to national stakeholders. In addition, the focal points are active in the
planning and implementation of EU-OSHA campaigns as well as nominating national experts to the
Agency’s groups and seminars.
Close functional links with the
Advisory Committee on Safety and Health at Work
and its working
parties and the
Senior Labour Inspectors Committee
and its working groups
•
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A
NNEX
II: S
UMMARY OF THE
F
EEDBACK
R
ECEIVED THROUGH THE
P
UBLIC
C
ONSULTATION ON THE
C
ALL FOR
E
VIDENCE FOR THE
I
NITIATIVE ON
(R
E
-)A
TTRIBUTION OF
S
CIENTIFIC AND
T
ECHNICAL
W
ORK ON
C
HEMICALS TO THE
EU A
GENCIES
The call for evidence was published on the Commission’s website ‘Have your say’ on 15 March 2022 and the
feedback period lasted 30 days, until 12 April 2022.
1. R
ESPONDENTS
In total, 65 submissions were received (61 unique submissions and 4 replicative submissions by the same
respondent), majority being from business associations and companies (in total around 70% of submissions),
followed by submissions from EU citizens (11%), non-governmental organisations (6%), public authorities
(6%), others (5 %) and academic/research institutions (1.5%).
Proportions of number of feedbacks received by category of respondents
As regards geographical variation, the majority of feedback was received from respondents from Belgium
(49%), followed by Germany (17%), Poland (8%), France (6%), Spain and Denmark (3% each) and UK,
Sweden, Slovakia, Portugal, Norway, Japan, Italy, Finland and Austria (2% each).
2.
T
YPE OF RESPONSES
Large majority of responses were relevant to the topic of the call for evidence. Only 3 responses were assessed
as not relevant to the 1S1A. They provided specific comments on the ongoing revisions of some pieces of
legislation but without relevance to the 1S1A or just a general critisism of the EU legal framework.
As this has been the first public consultation on an initiative under the 1S1A, a lot of feedback received was
not specific about the consulted initiative on the reattribution of task to the EU Agencies but about the general
scope of the 1S1A approach as well as other initiatives announced under the 1S1A. All feedback received is
however useful for the upcoming discussions, therefore, the text below summarises all relevant input received.
3.
S
UPPORT TO THE INITIATIVE ON
1S1A
Generally, there is a large support of the initiative among the respondents, whether of the 1S1A approach as a
whole or of the specific initiative on the reattribution of tasks. 67% of respondents expressed their explicit
support, 23% did not expressed explicitely their opinion but provided relevant advices on how to develop the
1S1A approach and about 10% expressed doubts about usefulness of the initiative or opposition to the
initiative.
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The well-implemented 1S1A initiative is seen by respondents as beneficial for both industry and regulators.
The respondents supporting the initiative identified the following benefits of the initiative:
- More uniform risk assessment across relevant chemical legislation; enhanced consistency of assessments
and their outcomes, carried out on the same dataset;
- Improved robustness of the assessments;
- Involvement of the right expertise at the right place at the right time;
- Provision of tailored assessments under specific legislations/uses if relevant;
- Optimal use of resources;
- Increased efficiency and predictability;
- Making use of synergies (phys/chem/tox data available at different EU agencies);
- Elimination of duplication of animal testing in the EU and a driver for both improved sustainability and
better protection of animals;
-
Strengthening trust between society and industry, whilst improving efficiency, and sound science-based
regulatory and political decision-making; achieving a robust and consistent approach to chemical
regulation;
Some respondent identified concrete past and on-going discrepancies and ineficiencies as regards the safety
assessment of chemicals that they hope to be avoided by the implementation of the 1S1A initiative. These are:
- Past discrepancy in assessments of phthalates and bisphenols between ECHA and EFSA and between
REACH and Food Contact Materials;
- On-going discrepancy in risk management measures on silicon dioxide under the biocidal product
regulation (where there is a low limit on its presence in biocidal products) and REACH (where this
substance is exempted from information requirements and can be sold in products at much higher
concentrations than in the biocidal products);
- Currently no link exists between the REACH and Food Contact Material legal framework as regards the
re-use of data, although the same substances are being regulated under both frameworks. On the chemical
side, over ten years of REACH implementation led to the generation of a very comprehensive
(eco)toxicological dataset on a wide number of substances, which is available to ECHA. It would be very
efficient and avoid unnecessary test and the repetition of studies, especially in vivo (animal studies), if this
data could be used for the risk assessment in the FCM framework by EFSA. Although the robust study
summaries provide some publicly available data, like toxicological end points, this is often not accepted by
authorities as the original studies behind the end points are requested, which cannot be accessed by the
authorities. Therefore, the link needs to be established between these two legislation and the legal
framework around the usage of such data should be modified and broadened to facilitate the reuse of already
available data and to allow other Agencies to access the REACH data.
- There is a need for an improved vertical coordination and collaboration between the expert panels of EFSA
evaluating the same substance. Challenges have previously been seen for e.g. fluoride, evaluated by the
EFSA nutrition panel but where the contaminants panel is also relevant. For chemical substances like
fluoride it is important that an evaluation covers both aspects of nutrition and toxicology. For some
contaminants we have also seen that JECFA and EFSA have evaluated the same substance with different
output/result. It would improve the use of resources if it were not necessary to have two different bodies
evaluating the same substance. However, as Codex Alimentarius refer to JECFA evaluations and EU
Commission to EFSA evaluations it will be challenging to accept/adopt the evaluation made by the other
Committee.
-
Currently, there is no central searchable database on environmental impacts of pharmaceuticals available.
Therefore, it is proposed to integrate the validated environmental information on pharmaceuticals held by
EMA in data platforms already used on a European level. The central database would also be a valuable
tool for endpoints of monograph systems for human and veterinary pharmaceuticals.
The respondents opposing or doubting the initiative provided the following arguments:
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- Did not observe problems with ‘duplication’ or ‘inconsistent outcomes’, although the substances they
produce/use fall within various regulatory domains;
- The initiative is likely to create more complexity, as well as a transition period which will considerably
affect substance evaluation and authorization processes and timelines, as well as the burden placed on
applicants. The latter will come on top of the increased complexity created by the recent implementation
of the Transparency Regulation and its requirements related to confidentiality justification and the new IT
tools to be used for notification and submission of dossiers to EFSA and the Commission.
- Several product specific regulations require special product qualities like e.g. a high purity and consider
very specific exposure possibilities.
The general goal of true “one substance, one assessment” is highly
difficult to implement, taking into account all possible applications and the various grades of a substance
on the market. The assessment of a substance requires a high level of expertise and detailed considerations.
-
It is important that chemicals used in the EU are assessed by several independent research teams, which
will reduce the risk of lobbying and increase the possibility of comparing test results.
Some confusions or misunderstandings could be observed in some of the responses provided. The most
common ones are:
- Some respondents considers that ECHA does only hazard assessment while EFSA does risk assessment.
The true is that both agencies do both, hazard and risk assessment. The confusion might originates from the
fact that ECHA does also harmonised classification of hazards under the CLP regulation, which is pure
hazard assessment, and respondents are not aware of their risk assessment work as part of the REACH
restriction process or implementation of the biocidal product regulation, POPs regulation or drinking water
directive.
- Some respondents fear that moving some assessments to ECHA will automatically result in hazard-based
regulation, omitting the use of exposure information. The true is that reattribution of tasks on safety
assessment will not change the risk management measures. In addition, as explained above, ECHA is also
doing risk assessments and has experience in doing so.
-
Some respondents fear of the ambition to create one new ‘risk assessment’ agency and consolidating all
risk assessments into such agency. There is no such intention. The objective of 1S1A initiative is to improve
cooperation between agencies and clearly distribute the relevant tasks among them with the objective to
improve coherence, efficiency and effectiveness of safety assessments.
4.
S
COPE AND OBJECTIVES OF
1S1A
Number of respondents provided their views and expectations regarding the scope and objectives of 1S1A.
The expectations and views expressed by the respondents regarding the general scope and objective of the
1S1A are as follows:
-
1S1A should ensure that the level of protection for the human health and the environment is not jeopardised
and remains high.
- 1S1A should work towards a coherent protection goals by developping a new EU Human Health Directive
that aims to achieve ‘good public health’, protecting humans from the combined action of chemicals and
combined action of chemicals and
non-chemical environmental stressors.
- 1S1A should be limited to one substance, one hazard assessment. The hazard assessment – the basic
evaluation of substance properties
–
should be
grounded in a single set of agreed scientific principles, as it
is independent of the area of application or legislation. Risk assessments and potential socio-economic
assessment however should remain tailored to their different purposes and legislation, taking into account
the use of, the exposure to the substance and particularities of the sector.
Risk management measures should
be also specific and tailor-made.
- 1S1A should ensure that for a specific use there is only one risk assessment performed across legislation
valuing existing expertise.
- 1S1A should ensure that all relevant assessments are updated if new data and new assessment lead to a new
TDI or PNEC value to ensure that all regulations rely on limit values derived from the latest knowledge. It
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should be considered in the new omnibus regulation to require updates in all sector specific regulations
within a given timeframe when a new TDI or PNEC value is derived by an EU scientific committee.
- The actions of 1S1A initiative should be focused on where duplication really appears, i.e. to
o
hazard assessment and classification, identification of acute concentration limits ATEs, local
effects specific concentration limits SCLs and NOAELs/LOAELs for human health,
ECxx/LCxx/NOECs for acute aquatic toxicity and other wildlife. Based on these endpoints, the
derivation of DNEL/OEL/TDI/ADI/PNECs/EQs, etc. may differ between legislations (REACH,
OSH, PPR, BPR, FCM, WFD) due to different methodologies to carry out their safety assessment.
o
substances used in different applications covered by different legislation.
- Although 1S1A is targeting on ‘chemicals’, it should be expanded also to microbials, natural substances
and semiochemicals used as biocontrol.
Biocontrol products themselves may be used for more than one
purpose; for example, micro-organisms are used in the area of crop protection, but also as fertiliser or
biostimulant under Fertilizer Product Regulation. The same micro-organism are used in agriculture and are
subject to different regulatory frameworks and thus to different sets of data requirements and procedures.
Ultimately this may lead to different and even contrary decisions, based on the same data package the same
micro-organism may be authorised for one area of use (e.g. as a biostimulant), but may not be approved for
another area of use (e.g. crop protection).
Establishing
within the EU a group of biocontrol experts is
recommended. To start, the group should consist of microbial experts from Member States, EFSA, ECHA,
and other relevant EU institutions that, in close cooperation with COM, will be responsible for all
evaluations and assessments of microbial active substances submitted in the EU for approval. This would
guarantee a consistent and scientifically sound approach that would considerably simplify and speed up
procedures. This should then be extended to cover experts in natural substances and semiochemicals.
- 1S1A should also aim to improve comparability of monitoring data across Member States in the area of
food contaminants.
Pursuant to Commission Regulation (EC) No 1881/2006, Member States are requested
to examine samples and provide necessary data that could lead to a comprehensive risk assessment. Despite
the European scope of the risk assessment, means to support such data collection is still largely maintained
at a Member State level, manpower and the financial means of Member States for this varies, which all
together may lead to national authorities providing data with high variability. This initiative on streamlining
scientific assessments is an opportunity for the Commission to support the integral role that national
authorities and European Reference Laboratories do to ensure the conclusions taken from these studies and
guidance documents are as robust as possible.
- Some respondents argued that veterinary medicinal product should be exlcuded from the scope of 1S1A,
while others were arguing for importnace to include also medicinal products, in particular as regards the
environmental data on medicinal and veterinary products.
The expectations and views expressed regarding the five specific areas of the 1S1A initiative identified in the
chemicals strategy for sustainability are as follows:
Coordination and initiation of the assessments
- Upfront close coordination of assessments should be established across different DG’s, Scientific
committees (including Scientific Panels), Agencies as well as Member States at European level, to decide
what is required, and who does what and when;
- A central coordination mechanism should be established, including a coordinated problem formulation
phase (i.e. identifying the correct scientific question that needs to be answered) which would enhance
predictability for industry;
- Mechanisms needs to be created to integrate assessments that specify the health and environmental
endpoints used by the different agencies;
- Different bodies active in the assessment of chemicals must ensure proper coordination of their work,
especially when they are assessing the same substance. This includes an exchange of information such as
results of previous assessments.
- Also the national authorities of each EU member state that should be active in the assessment of chemicals,
e.g. under REACH, are included in the “one substance, one assessment” initiative in order to prevent
diverging views between member states and/or EU authorities regarding the assessment of (groups of)
chemicals.
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- It is vital that the implementation of the “one substance, one assessment” approach contains provisions for
supporting greater interagency cooperation;
-
To make this system work it is recommended that evaluators/risk assessors from different regulatory bodies
attend each other meetings thus ensuring consistency and avoiding duplication of work;
-
Cooperation between EU and national agencies is crucial for a better usage of resources.
- It shall be avoided that overlapping evaluations and assessments are taking place in parallel within the same
regulatory context. Risk management measure processes should not be started during an on-going substance
evaluation, where data gaps may be identified and therefore pre-empting the step in the substance
evaluations that identifies the most appropriate risk management measures to be identified or data to be
gathered to be available;
Allocation of responsibilities
- Tasks should be reattributed amongst the agencies to ensure efficiency, by assigning the relevant
responsibilities to the pertinent agency rather than reshuffling already established responsibilities;
- Each body (i.e. authority, agency, working group, etc.) that is carrying out an assessment of (groups of)
chemicals should be equipped with sufficient expertise necessary for the specific assessment, e.g. in the
field of toxicology, ecotoxicology, occupational safety and health, exposure assessment, etc
- Cooperation between EU and national authorities should be also optimized. Synergies and overlaps must
be clearly identified. This area is not left out and there is a clear division of tasks.
Data
- Data exchange across Committees and Agencies should be ensured to avoid duplication of data submission;
a common information base needs to be created to avoid duplication of assessments, for example with an
open data platform on chemicals and tools for accessing relevant academic data;
- Exposure assessment tools and methodology could also be centralised on a common data platform;
- Access to all available data in the same structured format should be provided for all EU authorities. Equal
transparency regimes are applied across all sectors.
-
Academic data has a role to play in science-based policy making, however, there needs to be a process to
ensure that data is reliable and robust. There are 1000’s of studies related to titanium dioxide that are
published each year and the titanium dioxide industry has a comprehensive screening process in place
including regular updates of the REACH dossier. A lot of the academic data related to titanium dioxide is
not reliable or robust enough with basic information such as the identity of the substance unknown. The
other concern is the inherent bias as non-adverse outcome are less likely to be published. The OECD
Guidelines for the Testing of Chemicals were developed for this reason, and it is important that they remain
the key benchmark.
- We strongly support the proposal to introduce new tools for the 1S1A approach, which would further
improve the work of the industry and scientific committees in ensuring consumer safety by:
o
extending the use of the public activities coordination tool to other legislation
o
establishing an EU repository of human and environmental health-based limit values; and
o
establishing a common, open data platform on chemicals and tools for accessing relevant academic
data
-
We support the principle of harmonizing the format in which data is reported to enable data to be shared
between agencies. A harmonized data format will in our opinion lead to efficiencies and greater
transparency. To us a harmonized data format does not equal harmonized data requirements between
agencies since adequate data required for a risk assessment depends on the sector considered. It would be
important to have a systematic mechanism supported by the authorities to organize the request of data to
the manufactures to avoid duplication of efforts/resources and to guarantee a good agreement among the
interested parties. The format of all data collected should be developed in close collaboration with the
industry to ensure it is fit for purpose.
-
We are in favour of promoting the environmental biomonitoring and check how the establishment of that
limit values could benefit from this biomonitoring.
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- The legal framework around the usage of REACH registration data should be modified and broadened to
allow other Agencies to access such information, in order to prevent double work, but above all the
repetition of studies, especially in-vivo, for the same substances. With specific reference to evaluations
concerning food contact materials, we believe that EFSA would greatly benefit from access to registration
dossier data, with due consideration of data protection. Similarly, we believe that also MSCA should also
have access to the existing data. For instance with regards to FCM evaluations, this would enable them to
make evaluation on the same dataset used by EFSA, uniformizing the petitioning process by avoiding
divergence in the approach.
-
Environmental safety data already assessed by one of the European agencies should be available for
procedures under different EU regulations. This should also apply to environmental data from the veterinary
and human pharmaceutical legislation. Therefore, including EMA as agency responsible for the
environmental impacts of pharmaceuticals is highly welcome. Currently, there is no central searchable
database on environmental impacts of pharmaceuticals available. Therefore, it is proposed to integrate the
validated environmental information on pharmaceuticals in data platforms already used on a European
level. The central database would also be a valuable tool for endpoints of monograph systems for human
and veterinary pharmaceuticals.
Methodologies
- Clear, standardised approaches/protocols on hazard and risk assessments must be developed to ensure
consistency and predictability, while acknowledging the different needs of the different regulatory
frameworks. For example, in food safety related matters it is crucial to define health-based guidance values
from the context of food exposure only, and therefore the ways of assessing the hazard might divert from
other legislative areas where other routes of exposure are more prominent.
- The assessment of chemicals must be science-based.
-
Harmonisation of the methodologies for the assessment of chemicals should incorporate and expand the
use of non-animal New Approach Methods and next generation risk assessment tools (based on the
knolwdge acquired by SCCS), making this a default ‘one assessment’ framework applicable to all
chemicals.
-
Harmonisation of evaluation methodologies is needed. For example, the AOEL (acceptable operator
exposure level), DNEL (derived no-effect level), the MOS (margin of safety) and the OEL (occupational
exposure limit) are four different ways to set a threshold limit under Pesticides, REACH, the Cosmetics
Regulation and workplace regulation, respectively. Another example is the methodology used under the
Water Framework Directive to set environmental quality criteria with the purpose of protecting humans
from consumption of polluted fish and shellfish. This methodology differs from the methodology used by
EFSA and national food safety authorities to set limit values for edible fish, thereby resulting in different
limit values for the same substance.
Transparency rules
- Transparency on the decisions and processes is increased;
- All information regarding the evaluating authority, the process and status of the assessment as well as all
relevant documentation should be available to all stakeholders.
- Transparency rules should be also harmonized.
5.
R
EATTRIBUTION OF TASKS TO
EU
AGENCIES
Number of respondents provided their views on how the reattribution of tasks to the EU agencies should be
done. These are:
- Reattribution of work must not result in a single agency being responsible for the risk evaluations of all
chemicals.
A clear demarcation of responsibilities between relevant EU agencies and regulations is needed.
- The role, tasks and expertise of each agency should be clearly defined and exploited in a targeted manner.
Agencies should stay within their assigned areas of duty and abstain from political interventions.
Expertise
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- It is strongly suggested that expertise for risk assessment under the different regulations should stay with
the existing responsible agencies. Each
Agency is best positioned to lead and provide specific assessments
due to their extensive experience in product specific related matters, e.g., EFSA for food use, EMA for
medicines use.
- It shall be ensured that whatever body carries out the risk evaluation tasks it shall have available the
necessary and adequate expertise within the application domain of the use of the chemicals.
- We strongly encourage the Commission to review the functioning of the existing scientific committees,
agencies, consultants, etc. supporting scientific assessments to ensure that they have the relevant expertise
(both quantitatively and qualitatively) and always strive for opinions of the highest scientific excellence
and integrity
- Not all hazard endpoints are covered by all regulations. For the environment, the Plant Protection
Regulation is probably the most advanced as requiring testing on species not covered by other regulations
such as honeybees, earthworms, plants, beneficial arthropods, birds. Therefore, the derivation of these
endpoints should stay with the Agency having the expertise,
i.e.
EFSA.
- The reattribution should ensure that valuable expertise gathered by existing entities is preserved. The
knowledge of SCCS to perform risk assessment without animal use has to be preserved and cosmetics have
to continue use only data from non-animal tests. Transparent safety assessment process for cosmetics
should continue to be underpinned by the use and further development of the current Notes of Guidance
from SCCS.
Resources
-
The necessary resources must accompany new tasks to the agencies.
- Re-attribution of work should not lead to the situation that the Agency or committee is not able to handle
the workload and hence would jeopardise the quality of the work or result in the use of scientifically
unsound decisions/approaches.
Organisation of scientific committees
- Agencies might need to be reorganised to deal with increased workload. RAC in ECHA has already now
immense workload; In ECHA, MSC could be turned into the hazard assessment committee to deal with
CLP classification, RAC could focus only on risk assessments. It would be useful to also align panels in
EFSA as the same substance is evaluated by two panels.
-
Instead of creating new scientific panels, the agencies should be supported to be able to reinforce the expert
independent committees and working groups that already exist, with a certain level of flexibility and
openness in terms of reaching the best assessment.
- The safety assessment for consumer products should be performed by an independent commitee which has
equal status to hazard assessment committee (i.e. a safety assessment committee for consumer product
should not report into a hazard assessment committee).
Tasks to re-attribute
- For substances used in food contact materials the process should involve EFSA and ECHA. The process
should start with the hazard identification and characterization of substances, followed by an FCM specific
risk assessment. We recommend ECHA play a central role in the hazard assessment of chemicals, while
EFSA assess risks linked to their use in FCMs (which are highly specific compared to those for other uses
of chemicals).
- So far, a number of tasks have been distributed to ECHA, or are foreseen to be distributed to ECHA. This
includes e.g. opinions on health based limit values under OSH, derivation of limit values under the Drinking
Water Directive, evaluation of cosmetic ingredients under the Cosmetic Products Regulation, etc. However,
other areas have not been addressed such as e.g. derivation of environmental quality standards under the
Water Framework Directive, or opinions on chemical substances in e.g. toys by the scientific committee
SCHEER. It should be considered how to achieve harmonization in these areas as well, including if tasks
should be redistributed to one of the agencies (EFSA or ECHA)
-
The proposal should include as many substance regulations as possible within the EU legislative
framework, e.g. Toys directive, food and feed additives, environmental quality standards (EQS).
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Impact assessment
- Few respondents suggested to perform an impact assessment for the 1S1A initiative to make sure that
potential impacts on business operators are adequately considered and to make sure that businesses are
involved in the development of the initiative.
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A
NNEX
III: D
ETAILED IMPACT ANALYSIS OF THE
(
RE
-)
ATTRIBUTION OF
SCIENTIFIC AND TECHNICAL WORK RELATED TO CHEMICALS TO
EU
AGENCIES
1. D
RINKING WATER DIRECTIVE
(2020/2184)
Responsible body:
Currently: N/A, no current process exists at EU level
(Re-)attribution planned to: ECHA
Legal basis for reattribution:
Revision of drinking water directive
Type of task:
New
Brief task overview:
Establishing and maintaining four EU positive lists for substances and
compositions authorised to be used for the manufacture of materials in contact with water intended
for human consumption.
Detailed process description:
Current process:
N/A, no process exists at EU level
New process:
1.
From national lists to the first EU positive lists (review programme)
The Commission, supported by ECHA, compiles the first EU positive lists for substances and
compositions used in the manufacture of organic, cementitious, metallic and inorganic materials in
contact with water intended for human consumption. These first positive lists are based on national
positive lists notified to ECHA by July 2021; in addition, the positive list for organic materials will
incorporate the plastic FCM positive list of Regulation (EU) No. 10/2011. All entries in the EU
positive lists will be subject to a review. To this end, each entry will be accompanied by an expiry
date by which industry needs to submit an (review) application to ECHA. The burden of proof is with
industry: if industry wishes to keep a substance or composition on the EU positive list, they need to
submit an application by a specified deadline. If no application is received by the deadline, the
substance or composition is removed from the positive list.
It is estimated that the first EU positive lists will contain approximately 2000 entries with assigned
expiry dates of 2028, 2031, 2034 and 2037 depending on the hazard of each entry and the availability
of past risk assessments. The first European positive list will be adopted by January 2024, the first
review applications can be submitted as from January 2026 and the whole review programme shall
be finished within 15 years by end December 2039.
2.
Updating the EU positive list
Once established, ECHA will need to manage the EU positive lists through the addition, removal and
updating of entries in the lists. The process can be triggered by:
a. An economic operator who wishes to add a substance or composition to an EU positive list
or has to submit a review application for an existing entry;
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b. An authority that has a reason to propose removing a substance or composition from an EU
positive list or to update an entry;
c. ECHA, that may submit an application on the Commission’s request.
Once an application is received, the process at ECHA contains the following main steps:
•
•
•
•
•
Automated and manual checks of the application to verify completeness and accordance
with the information requirements which will be set out in implementing legislation;
Dissemination of information and consultation of interested parties;
Opinion development via the RAC committee;
Support to applicants and Member State Competent Authorities;
Technical and scientific support to the Commission.
The first review applications can be submitted as from January 2026.
Proximity to ECHA mandate:
The work is close to the ECHA core mandate of assessing the risk of chemical substances based on
industry applications and many of the core competences are already present in the Agency.
Projected synergies and added value of (re-)attribution:
Type
Reuse of
capabilities
Synergies
High
Process and expertise: ECHA already supports similar work on substance risk
assessment under REACH and other legislation. Several key capacities can be
reused/reinforced:
-
-
-
Re-use of data
Medium
Hazard, risk and exposure assessment
Committee opinion development
Existing IT capabilities for industry dossier submission, stakeholder
consultation and dissemination
Reuse of substance identification and hazard data collected under other chemical
legislation. Currently low availability of data on substances in products and no data
available on migration of substances to water.
With an estimated workload of developing 50-150 RAC opinions annually, there is
little room for workload balancing.
Industry actors can submit their applications reusing existing ECHA submission
tools, which will be adapted to the needs of the EU positive lists, at the same time
automating the existing process. In addition, reuse of IT capabilities for case
management, public consultation, interaction with Member States, regulatory
intentions management and data dissemination.
Reuse of scientific support services (e.g. committee secretariat, prioritisation and
grouping of substances, substance identification, data management and
dissemination). Reuse of administrative services.
Workload
balancing
IT tools:
automation and
economies of
scale
Low
High
Support
services:
economies of
scale
High
Type
Scientific
consistency
Added value
High
Opportunity to align priority setting, timeline, process and methodology at EU
level to improve equal EU market access and coherence in the scientific advice
provided to the Commission. Reuse of assessment insights developed under other
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chemical legislation. Opportunities to put into practice the One Substance-One
Assessment for substances of interest to both drinking water (ECHA) and food
contact materials (EFSA).
Robustness
assessment
acceptance
Independence
of
and
High
Harmonising market access and scientific work from Member State level to EU
level. Additional involvement of RAC committee adds more scientific robustness
to the process.
Moving scientific work from Member State level to EU agency experts and
committees. ECHA and its committees work under strict conflict of interest
avoidance rules, improving guarantees of independent scientific advice to the
Commission.
ECHA’s involvement will ensure transparency to the process:
-
-
-
-
-
Overall process transparency
Publication of regulatory intentions of EU authorities and application
submission intentions improves predictability for all stakeholders
Public consultation/call for evidence
Stakeholder involvement/observer status
Dissemination of scientific data and outcomes
High
Transparency
High
Main risks and opportunities:
The high impact of the work on the RAC committee needs to be
addressed.
Projected impact on ECHA:
•
ECHA Committees/bodies:
high impact.
The task generates major impact on the setup /
organisation / staffing of Committees/bodies due to significant additional workload
RAC
Process
# of
opinions
per year
50-150
rapporteur
Type of
opinion
SEAC
# of
opinions
per year
0
rapporteur
Type of
opinion
Assessment of
applications and
dossiers
RAC member
•
•
ECHA data model and IT infrastructure:
low impact.
The task can be implemented with
adjustments / configuration of existing data structures and IT systems
ECHA key experts:
high impact.
The task heavily relies on existing expert competencies
which are limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks, as
well as new competencies which ECHA should acquire (e.g. migration assessment and
materials science)
Workload and resource implications:
Current workload and resource use:
N/A, no current process exists at EU level
Future workload and resource needs:
The Directive is in force since 2021. Industry can notify their intention to submit an application from
January 2025 with the first industry applications expected from January 2026 onwards.
A total of 3 new full-time equivalent temporary agent staff (AD 5-7) (average cost EUR 136 000/year,
during 4 years) and 2 full-time equivalent contract agent staff (CA FG III, average cost EUR 65
000/year), have been allocated to ECHA to set up the system. After 4 years, the review process will
necessitate additional resources, i.e. 10 FTE on average for the next 4 years (7 temporary agent staff
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and 3 contract agent staff). A new assessment of the needs will be completed at the end of the period
on the basis of the experience gained during the first years of functioning of the system. According
to first estimates, additional staff (around 3 FTE, i.e. bringing the total to 13 FTEs) might be needed
to complete the review of all substances on the positive lists in a reasonable deadline (15 years).
In addition to staff costs, EUR 1 000 000 is reserved for the first 3 years annually to set up the IT
systems, whereas roughly half of this amount will be needed for maintenance work after the set-up
period. Infrastructure expenditure has been estimated at 24% of the staff expenditure.
The aforementioned resources have been estimated using a calculation model which takes account of
relevant experience from tasks executed by ECHA under other regulatory frameworks (e.g. REACH,
CLP, BPR) and from the implementation of the existing national approaches where relevant. It sets
out the resources that will be needed by ECHA over a time window of 20 years, including a review
programme running over 15 years, in order to handle the foreseen tasks.
The estimated resources for the process to review and update the EU positive lists are
application/dossier driven. The number of applications/dossiers have been estimated on the basis of
substances on lists currently in use by the Member States and that have been registered under
REACH. Member States’ forecasts were used to estimate the flux of incoming applications/dossiers.
The key tasks involve examination of the applications/dossiers, opinion development and decision
process. The estimated resources for the initial setup, ICT process infrastructure and development of
methodologies, for the process from national lists to the first EU positive lists as well as the resources
involved in other tasks such as helpdesk, legal support are task driven regardless of the number of
dossiers.
Once the routine phase for dealing with the tasks under the proposed recast of the Directive has been
approached (from the tenth year onwards), about 70 % of the resources will be involved in the
operational work (dossier and opinion related efforts).
Additional limited resources might be necessary for EFSA in case the existing system of FCM (under
evaluation) is still in place when the review will start (after 2025) to ensure coordination on the review
of the plastic lists. These potential additional resources are not included in the present estimate.
Summary of additional resource needs for the drinking water directive regulation:
Agency
ECHA
Summary of tasks
- Establishing and maintaining four EU
positive lists for substances and
compositions authorized to be used for the
manufacturing of materials in contact with
water intended for human consumption
Resource needs
Financial resource
needs:
2021:
EUR 1 000 000
2022:
EUR 1 000 000
2023:
EUR 1 000 000
2024:
EUR 510 000
2025:
EUR 520 000
2026:
EUR 530 000
2027:
EUR 540 000
2021:
3 TA, 2 CA
2022:
3 TA, 2 CA
2023:
3 TA, 2 CA
2024:
3 TA, 2 CA
2025:
6 TA, 3 CA
2026:
7 TA, 3 CA
2027:
8 TA, 3 CA
Human resource
needs:
Future budget line: DG Environment
Candidate for fees: Yes - for authorisations, No - for others
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2.
R
EGULATION ON SERIOUS CROSS
-
BORDER THREATS TO HEALTH
(2022/2371)
Responsible body:
Currently: Commission with the support of the SCHEER Committee
(Re-)attribution planned to: ECHA, EEA, EFSA, EMA
Legal basis for reattribution:
proposal for regulation on serious cross-border threats to health.
Type of task:
existing
Brief task overview:
ECHA, EEA, EFSA, EMA, ECDC, EMCDDA are tasked, on the request of the
Commission, to carry out “a risk assessment of the potential severity of the threat to public health,
including possible public health measures” when there is an alert of a cross-border threat of chemical
origin (see draft article 20.1(c)).
Detailed process description:
Current process:
Decision 1082/2013/EU on serious cross border threats to health (the Decision) layed down rules on
combating serious cross border threats to health. Where there is an incident or alert of an actual or
potential serious cross-border threat to health that fulfils the criteria detailed in Article 9 of the
Decision (Box 1), the Commission shall, where necessary for the coordination of the response at
Union level and upon request of the Health Security Committee (HSC) or on its own initiative, make
promptly available to the national competent authorities and to the HSC, through the Early Warning
Response System (EWRS), a public health risk assessment of the potential severity of the threat to
public health, including possible public health measures.
In operational terms, the Commission and the HSC may request the SCHEER to undertake rapid risk
assessments (within 72h) in case of chemical cross border public health threats from both manmade
and naturally occurring events (e.g. chemicals released during an incident or during a volcanic
eruption) that may have an impact on health (hereafter chemical health threats). The assessment did
not cover the wider effects on the environment which are outside the scope of addressing the effects
on human health (e.g. biological effects on ecosystems) as these were outside of the remit of the
Decision and would therefore have to be taken forward through other existing mechanisms, e.g.
through a separate mandate or different body.
To implement this obligation, SCHEER has developed a guidance in ad hoc rapid risk assessment of
serious cross-border chemical health threats. SCHEER set up and maintained a continuous readiness
to provide rapid risk assessments (within 72h) where urgently needed by setting up a SCHEER
permanent working group on rapid risk assessment. The committee held on average 10 meetings per
year and performed regular crisis exercises.
Changes in the process:
The responsibility for rapid risk assessment for risks of a cross-border threat that is linked to medicinal
products and medical devices is assigned to EMA, for risks of a cross-border threat of chemical origin
is shared between ECHA and EFSA based on their mandate and for risk of a cross border threat of
threats of environmental origin, including those due to the climate, are shared among ECHA, EFSA
and EEA based on their mandate.
Proximity to Agencies (ECHA, EEA, EFSA and EMA) mandate:
EFSA has been already involved
in the rapid risk assessment based on the old system, in parallel with SCHEER, and thus have
developed expertise and procedures. For ECHA and EMA this is a new task. While they have certain
expertise in the area of chemical or environmental risks, they do not have dedicated expertise related
to risk management of chemical incidents, nor do they hold data on emissions into the environment.
For EEA is a new task too but EEA holds data on emissions into the environment and there are some
synergies with (re-)attribution of SEVESO III work on chemical accidents.
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Projected synergies and added value of reattribution:
Type
Reuse of
capabilities
Synergies
Medium
Process and expertise:
ECHA, EFSA and EMA already provides scientific advice on chemical
substances under their mandate. Therefore, the existing capacities on hazard, risk
and exposure assessment can be reused/reinforced.
EEA is to be responsible also for SEVESO directive dealing with chemical
accidents and this expertise can be partly reused.
Re-use of data
Medium
ECHA, EFSA, EMA and EEA can reuse of data collected under other legislation
within their mandate.
With only sporadic requests for advice, the workload of Agency experts can be
balanced.
Not an IT-intensive process, but reuse of IT capabilities for case management,
interaction with Member States and external experts.
Workload
balancing
IT tools:
automation and
economies of
scale
Support services:
economies of
scale
Medium
Medium
Medium
Reuse of scientific support services (e.g. data management and coordination with
Member States and external experts). Reuse of administrative services.
Type
Scientific
consistency
Added value
Medium
Opportunity to align process and methodology with other related legislation to
improve coherence in the scientific advice provided to the Commission. Reuse of
data collected under other legislation.
Centralising scientific work from dispersed Commission services and
committees to EU Agencies and their experts.
Robustness of
assessment and
acceptance
Independence
Medium
Medium
Agencies are independent of the Commission and their experts have to fulfil
strict non-conflict rules.
Agencies involvement will bring additional transparency to the process:
Transparency
Medium
-
-
Overall process transparency
Dissemination of opinions and outcomes
Main risks and opportunities:
It might be challenging for Agencies to set up and maintain a
continuous readiness to provide rapid risk assessments (within 72h) where urgently needed, similar
to what is currently available through the DG SANTE secretariat and members of the SCHEER
committee.
Projected impact on Agencies (ECHA, EFSA, EMA, EEA):
•
•
•
Agencies Committees/bodies:
no impact.
The task does not require involvement of ECHA
Committees/bodies
Agencies data model and IT infrastructure:
no impact.
The task does not require adjustment
of data structures and IT systems
Agencies key experts:
medium impact.
The task partly relies on expert competencies that
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are currently not present within the Agencies and will therefore need to be acquired and
developed
Workload and resource implications:
Current workload and resource use
DG SANTE Health Security unit leads this process (resources spent unknown), but the main work is
carried out by the SCHEER Committee dedicated working group (on average 10 meetings / year +
regular crisis exercises, etc.). With this level of activity this work is estimated to take up at least 20%
of the work time of the DG SANTE SCHEER secretariat (= ca. 0.6 FTE/year) and require significant
time from the SCHEER members. In addition, the operational budget for the reimbursement of
members is at least EUR 48 000 (20% of EUR 240 000/year)
DG SANTE (Health Security unit)
DG SANTE (SCHEER secretariat)
Ca. 0.6 FTE (ca. 20% of SCHEER capacity)
EUR 48 000 operational SCHEER budget (at
peak EUR 68 000)
Ca.
0.6 FTE
Total
Current budget line: DG SANTE
Future workload and resource needs:
The work performed by SCHEER will be shared among several agencies based on their expertise and
mandate. The requests for rapid risk assessments are made on ad hoc basis and are not very frequent.
Considering the existing expertise in the agencies, the existing network of experts, low abundancy of
the requests, it is expected that the Agencies can absorb the tasks without additional resources.
Summary of additional resource needs for the regulation on cross-border threats to health:
Agency
ECHA,
EEA, EFSA,
EMA,
ECDC,
EMCDDA
Summary of tasks
- contribution to the public health risk
assessment
Resource needs
Financial resource
needs:
2024:
EUR 0
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2024:
0 FTE
2025:
0 FTE
2026:
0 FTE
2027:
0 FTE
Human resource
needs:
Future budget line: None – no resources allocated
Candidate for fees: No
3.
E
UROPEAN
P
ARTNERSHIP FOR THE
A
SSESSMENT OF
R
ISKS FROM
C
HEMICALS
(PARC)
Responsible body:
Currently: N/A, no current process exists at EU level
(Re-)attribution planned to: ECHA, EEA, EFSA
Legal basis for reattribution:
None, voluntary (ECHA and EFSA) or grant (EEA) agreement to
participate in the project
Type of task:
new
Brief task overview:
Participate in and provide input and support to the European Partnership for
the Assessment of Risks from Chemicals
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Detailed process description:
PARC is one of the projects selected for funding by the European Union’s "Horizon Europe"
framework programme for the 2021-2027 period. It is a 7-year partnership that started on 1
st
May
2022 and that consists of 200 partners in 28 countries and at EU level, national agencies and research
organisations working in the areas of the environment or public health, the European Chemical
Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environment
Agency (EEA).
PARC aims to advance research, share knowledge and improve skills in chemical risk assessment.
By doing so, it will help support the European Union's Chemicals Strategy for Sustainability, paving
the way for the "zero pollution" ambition announced in the European Green Deal.
PARC represents a campaign of unprecedented scale, since it brings together about 200 European
players, involving national and European health and safety agencies as well as research organisations.
The partnership encompasses all aspects of chemical risk assessment, aiming in particular to: better
anticipate emerging risks, better account for combined risks, and underpin the concrete
implementation of new orientations in European public policies to safeguard health and the
environment in response to important issues for health, the ecology and citizens' expectations.
The partnership builds on work undertaken as part of the European Joint Programme on human
biomonitoring, HBM4EU (Human Biomonitoring for Europe), which came to an end in the summer
of 2022, and broadens the scope of its interests specifically to the assessment of environmental risks.
Main objectives of the PARC are:
•
•
•
Develop the scientific skills needed to address current and future challenges in chemical safety
Provide new data, methods and innovative tools to those responsible for assessing and
managing the risks of chemical exposure
Strengthen the networks which bring together actors specialised in the different scientific fields
contributing to risk assessment
The EU Agencies (ECHA, EFSA and EEA) are to contribute to, participate in and support various
workpackages of PARC.
Proximity to mandate:
The task is close to EEA, EFSA and ECHA mandate and key competences
regarding risk assessment of chemicals, management and interpretation of data related to chemicals.
Projected synergies and added value of (re-)attribution:
PARC consortium will benefit greatly
from invlovement of EU Agencies that hold experience in performing regulatory risk assessment and
hold knowledge and data for such assessments. Through their experience they can identify gaps and
needs requiring scientific development and steer such development in a direction that provides the
highest value for the regulatory risk assessment. The EU Agencies will benefit from the participation
as well. They can uptake immediately in the regulatory risk assessment any innovation in risk
assessment that PARC will deliver.
Projected impact on Agencies:
•
•
•
Committees/bodies:
no impact.
The task does not require involvement of Agencies’
Committees/bodies
Data model and IT infrastructure:
no impact.
The task does not require any new data
structures and IT systems/capabilities
Key experts:
medium impact.
The task will require experts in the field to participate in the
projects.
Projected workload and resource implications:
Future workload and resource needs:
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ECHA participates fully in the project (i.e. as a signatory of the consortium agreement) but without
(co-)financing from the foreseen Horizon Europe subsidy to PARC and without requesting an
increase of its EU contribution. To compensate for the workload that PARC will generate, ECHA
will increase its allocation of Contract Agents by two and will finance them from economies of scale
and efficiency gains. This solution will be temporary until the Commission revises the founding
regulation of ECHA. This revision will be an opportunity to adjust and clarify the future mandate of
ECHA in the light of the existing and new tasks and assess its resources needs. The role of ECHA in
the research projects under Horizon Europe will also be clarified in the proposal.
EFSA participates fully in the project (i.e. as a signatory of the consortium agreement) but without
(co-)financing from the foreseen Horizon Europe subsidy to PARC and without requesting an
increase of its EU contribution. EFSA has dedicated resources for involvement and follow up of
relevant EU funded research projects.
EEA participates fully in the project with (co-)financing from the Horizon Europe subsidy to PARC.
EEA will finance from the subsidy 2 additional FTEs (2 CAs).
Summary of additional resource needs for PARC:
Agency
EEA
Summary of tasks
Resource needs
Financial resource
needs:
2022:
EUR 289 000
2023:
EUR 289 000
2024:
EUR 289 000
2025:
EUR 289 000
2026:
EUR 289 000
2027:
EUR 0
2022:
2 CA
2023:
2 CA
2024:
2 CA
2025:
2 CA
2026:
2 CA
2027:
0 CA
2022:
EUR 0
2023:
EUR 0
2024:
EUR 0
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2022:
2 CA
2023:
2 CA
2024:
2 CA
2025:
2 CA
2026:
2 CA
2027:
0 CA
2022:
EUR 0
2023:
EUR 0
2024:
EUR 0
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2022:
0 TA, 0 CA
2023:
0 TA, 0 CA
2024:
0 TA, 0 CA
2025:
0 TA, 0 CA
2026:
0 TA, 0 CA
2027:
0 TA, 0 CA
Human resource
needs:
ECHA
Financial resource
needs:
Human resource
needs:
EFSA
Financial resource
needs:
Human resource
needs:
Future budget line: DG Environment, DG GROW, DG RTD
Candidate for fees: No
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4.
C
OMMISSION IMPLEMENTING DECISION
2022/1979
UNDER
SEVESO
DIRECTIVE
Responsible body:
Currently: Commission (DG JRC)
(Re-)attribution planned to: EEA
Legal basis for reattribution:
Commission Implementing Decision
Type of task:
existing tasks plus some improvements
Brief task overview:
Redevelopment of databases (eMARS and eSPIRS) by the EEA for the
reporting of information on industrial major accidents and for reporting of the location of Seveso
establishments. It will integrate some improvements in the reporting format, the workflow and the set
of reporting tools.
Detailed process description:
The process is described in detail below in the section on projected
workload
Proximity to mandate:
The task is close to EEA key competence on receiving and processing
reporting information. The agency has the IT and networking infrastructure that is similar to the tasks,
such as operation of the European pollutant release and transfer register, reporting under the industrial
emission directive, the F-gas regulation or ozone depleting substances regulation.
Projected synergies and added value of (re-)attribution:
Main risks and opportunities:
Projected impact on EEA:
•
•
•
EEA Committees/bodies:
no impact.
The task does not require involvement of EEA
Committees/bodies
EEA data model and IT infrastructure:
high impact.
The task requires investment in a new
data structures and IT systems/capabilities
EEA key experts:
high impact.
The task will require a new dedicated expertise
Projected workload and resource implications
Current workload and resource use:
The development and operation of databases (eMARS and eSPIRS) for the reporting of information
on industrial major accidents and for reporting of the location of Seveso establishments and providing
supporting services was performed by DG JRC. The work was performed by 4 FTEs, 1 FTE was an
official of DG JRC, and 3 FTEs were external consultants.
Current budget line: DG JRC (core staff) + DG Environment (contractual support)
Future workload and resource needs:
A/ During the redevelopment phase of eSPIRS and eMARS (2023-2025)
IT infrastruture
One-off cost:
-
EUR 275 000 and then EUR 200 000 are reserved for the two first years to set up the IT
eSPIRS systems and the support of Member States to facilitate their reporting within the new
platform, which will be developed by the EEA.
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EUR 60 000 is reserved for the two first years to set up the IT eMARS systems. This amount
is lower compared to eSPIRS because some tasks will be mutualised between eSPIRS and
eMARS.
Yearly cost:
-
From 2024, the running costs of the two databases require 70 000 EUR per year (hosting of
tools, maintenance of software, infrastructure and support for the quality assurance of data
deliveries).
-
Staff, 4 agents are needed for the period 2023-2025 for the following roles:
-
2 IT staff agents :
thanks to the mutualisation of tasks related to the IT deployment, continuous
improvment and support to Member States for the the future eSPIRS and eMARS databases, the
need of staff is limited to: one full-time equivalent temporary agent (AD TA) (average cost EUR
199 576/year) and one full-time equivalent contract agent staff (CA) (average cost EUR
107 666/year) at the EEA:
o
1 AD TA“IT expert – database systems redevelopment”. Objective:
to support the
implementation of the new IT information system necessary for the eSPIRS and eMARS
reporting:
▪
IT project management of the redevelopment of new tools and reporting system,
ensuring design of alignment and complementarity with the existing EEA software
used for the reporting of industrial information to the EU Registry on Industrial Sites.
As part of the redevelopment and implementation of the new tools, the agent will lead
on the following:
•
•
•
Update the data model. This consists in the design and proposal of UML model,
feature descriptions and deployment and updating the code lists.
Support on updating the technical guidance.
Integration of the data model changes across the reporting infrastracture. This
includes, among others:
o
Update of the XML schema and EEA dictionary: the existing schemas and
code lists in the EEA data dictionary have to be updated according to the
agreed data model version.
o
Update of Quality Assurance (QA) scripts: with support from Member State
Competentent Authorities, stakeholders and thematic experts (see below), the
agent will assess the need of new automated Quality Assurance/Quality
Control (QA/QC) in view of the newly included reporting requirements.
Should this be required, the agent will also integrate these in the reporting
infrastructure. Changes in the logic of the data model may also need
adjustments of existing QA/QC.
o
Update of conversion services: this refers to a service of converting an user-
friendly template into EU Registry-compliant XML reports. This service will
need to be updated.
o
Update of harvesting routines: this relates to updating the systems used to
incorporate the data reported by Member States into the EEA databases.
o
Support for the update of the manual for reporters.
Design and run tests for the future reporting tools.
Launch and if necessary revise/adjust reporting tools: according to experience
with the design and deployment of the EU Registry of indutrial sites, a period of
around two reporting cycles is needed for all countries to fully succeed in sending
high-quality data. The IT speecialist’s role will be to incorporate possible
70
•
•
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changes/adjustments to the reporting tools if necessary, as well as provide
technical support to possible IT queries from Member States. It is expected that
these will be more numerous and complex during this early period and will
stabilise once all systems are in place.
•
Adjustment of public-facing products (IT):
o
Generation of EU datasets.
o
European Industrial Emissions Portal.
Whereas the data currently reported to eSPIRS could be integrated in the existing
IT infrastructure (with the required changes outlined above), it is possible that
eMARS will require its own database/IT infrastructure. This is mainly related to
the nature of the data currently reported to eMARS and the specific legal
requirements related to the rapid reporting of industrial accidents. The agent will
evaluate the possible options and work on the design and development of such
dedicated IT environment if necessary, as well as contribute to the development
of its support documentation (e.g. manuals, guidance). Also, the agent will provide
their IT expertise in the process of amending Commission Implementing Decision
(CID) 2014/895/EU establishing the format for communicating the information
referred to in Article 21(3) of Directive 2012/18/EU (i.e. implementing the
reporting of accidents, i.e. the eMARS dataflow). This will ensure the language
and structure of the Decision are suitable, clear and compatible with the fture IT
requirements.
•
▪
Performing the internal EEA function of “data custodian” involving the maintenance
of databases, developing and updating automated quality assurance scripts, data
harvesting scripts and IT dimensions of updating the website European Industrial
Emission Portal.
Ensuring that confidentiality, data protection and IT security protocols are maintained
to the standards required by the EU Institutions, from the design phase throughout the
pre-operational and operational phases.
Ensuring a secure access and use of the data that are marked as confidential, in
accordance with Article 4 of Directive 2003/4/EC
49
. These data shall neither be
publically available nor accessible (directly or indirectly).
▪
▪
o
1 CA “Member State and stakeholder support”. Objective:
to support the transition to
the future tools with the following tasks:
▪
Support to the development of the technical guidance for reporters. This support will
focus on coordinating the stakeholder validation of the technical materials by the
reporters’ community and incorporate their feedback in the materials. The agent will
engage with the current community of Seveso reporters and will also coordinate
contacts with EU registry reporters, who will also be affected by the changes and who
will have to liaise with their colleagues reporting on Seveso for the submission of data.
The agent’s role early on in the process is crucial for ensuring that the system is fit for
purpose and incorporates the realities of all EU Member States.
Support on Member State validation of new automated QA/QC checks and on
obtaining feedback during the necessary testing phase/s for the tools.
Support on Member State validation of manual for reporters.
▪
▪
49
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environmental information
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▪
From a strategic point of view and in view of the experience with the EU Registry,
building the foundation of a efficient relationship with the Seveso community of
reporters requires time. Starting this at the development phase is also relevant for a
smooth run of the process once implemented and ensures dedicated support and
validation to minimise the risk of unnecessary changes and issues later in the process.
-
2 thematic staff agents for for eSPIRS and eMARS:
2 full-time equivalent temporary agents
(AD TA) at the EEA (average cost EUR 199 576/year) for the thematic and analytic tasks linked
to eSPIRS and eMARS:
o
1 AD TA “Subject matter expert – eSPIRS Seveso reporting”. Objective:
to lead the
EEA activities relating to eSPIRS reporting redevelopment and ensure close links with other
EEA activities on zero pollution and reporting streams under environment law on industrial
emissions. It will fulfill the following tasks:
▪
Supervising the redevelopment of the eSPIRS reporting tools by providing the
necessary thematic (expert) perspective. Among others, the agent will ensure that the
changes to the data model and XML schema are compliant with the reporting
requirements and are fit for purpose, design and test automated and manual QA that is
suitable for this dataflow, lead the update of the technical guidance and manual for
reporters, and interpretation of the legal requirements for their implementation into the
data model, with support with IT expert and Member State support expert (see above).
▪
Capacity building and support to the reporters in countries to define the requirements
of the new eSPIRS reporting tools, train them in their use and assist the interpretation
of the requirements.
▪
During the redevelopment phase, liaising with the European Commission services to
support Member States when designing their reporting systems and tools, including
agreeing ad-hoc adjustments relevant to each Member State legal and operational
frameworks.
▪
During the redevelopment phase, liasing with the JRC as necessary on historical issues
and topics that may be of relevance for the new tools.
▪
Work is ongoing for the design of the Zero Pollution monitoring indicators framework
and indicators for the Chemicals Strategy for Sustainability. The agent will participate
in the process to assess how this dataflow can support and design possible indicators.
▪
Work is ongoing for the design of the Zero Pollution monitoring indicators framework
and indicators for the Chemicals Strategy for Sustainability. The agent will participate
in the process to assess how this dataflow can support and design possible indicators.
▪
Adjustment of public-facing products (thematic perspective):
•
Generation of EU datasets.
•
European Industrial Emissions Portal.
o
1 AD TA “Subject matter expert – eMARS Seveso reporting”. Objective:
to lead the
EEA activities relating to eMARS reporting redevelopment and ensure close links with other
EEA activities on zero pollution and reporting streams under environment law on industrial
emissions. It will fulfill the following tasks:
▪
Supervising the redevelopment of reporting tools by providing the necessary thematic
(expert) perspective. Among others, the agent will ensure that the changes to the data
model and XML schema (or design of new IT tool if necessary) comply with the
reporting requirements and are fit for purpose, design and test automated and manual
QA that is suitable for this dataflow, lead the update of the technical guidance and
manual for reporters, including the interpretation of the legal requirements for their
implementation into the data model, with support with IT expert and Member State
support expert (see above).
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▪
▪
▪
▪
▪
▪
▪
▪
CID 2014/895/EU would most likely need amendments and adapting to either the
existing IT infrastructure or a tailored infrastructure compliant with the INSPIRE
Directive and other requirements on data quality, security and transparency. The
thematic expert will support the Commission in the identification of current and
possible future requirements to design the data structure required in the future tools.
The expert will also assist the Commission during the adoption of the proposed legal
act through Committee deliberation. To ensure that the outcome is workable for the
EEA, the expert will be involved as observer throughout the process to advise on
consequences of the potential changes that the comitology process may bring.
During the redevelopment phase and beyond, capacity building and support to the
reporters in countries to define the requirements of the tools, train them in their use
and assist the interpretation of the requirements.
During the redevelopment phase, liaising with the European Commission services to
support Member States when designing their reporting systems and tools, including
agreeing ad-hoc adjustments relevant to each Member State’s reality.
During the redevelopment phase, liasing with the JRC as necessary on historical issues
and topics that may be of relevance for the new tools.
Work is ongoing for the design of the Zero Pollution monitoring indicators framework
and indicators for the Chemicals Strategy for Sustainability. The agent will participate
in the process to assess how this dataflow can support and design possible indicators.
Adjustment of public-facing products (thematic perspective):
•
Generation of EU datasets.
•
European Industrial Emissions Portal.
To ensure confidentiality, personal data protection and IT security standards are met
given the sensitive character of these information exchanges and thus keeping systems
at a state-of-the art level.
To ensure a secure access and use of the data that are marked as confidential, in
accordance with Article 4 of Directive 2003/4/EC
50
. These data shall neither be
publically available nor accessible (directly or indirectly).
B/ After the redevelopment phase of eSPIRS and eMARS (2026 and beyond)
IT Infrastructure
Yearly cost:
-
The running costs of the two databases require 70 000 EUR per year (hosting of tools,
maintenance of software, infrastructure and support for the quality assurance of data deliveries).
Staff, 4 agents are needed from 2026 for the following roles:
-
IT staff agents :
thanks to the mutualisation of tasks related to the IT deployment, continuous
improvment and support to Member States for the the future eSPIRS and eMARS databases, the
need of staff is limited to one full-time equivalent temporary agent (AD TA) (average cost EUR
199 576/year) and one full-time equivalent contract agent staff (CA) (average cost EUR
107 666/year) at the EEA:
o
1 AD TA“IT expert – database systems development and maintenance ”. Objective:
to
support the implementation of short-term IT development priorities and long-term system
maintenance. The agent will address all aspects relating to the IT dimensions of the reporting
50
Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to
environmental information
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flows and the storage and use of the databases generated by this exchange of information
between Member States and the EEA:
▪
IT support to Member States following the redevelopment phase: According to
experience with the design and deployment of the EU registry of indutrial sites, a period
of around two reporting cycles is needed for all countries to fully succeed in sending
high-quality data. The IT speecialist’s role will be to incorporate possible
changes/adjustments to the reporting tools if necessary, as well as provide technical
support to possible IT queries from Member States.
▪
IT project management of improved tools and reporting system, ensuring alignment and
complentarity with the existing EEA software used for the reporting of industrial
information to the EU Registry on Industrial Sites. As part of the development and
implementation of improvmements, the agent will lead on the following:
•
Identify improvements.
•
Update the data model.
•
Support on update of the technical guidance.
•
Integrate the improved data model across the reporting infrastracture.
•
Support for the update of the manual for reporters.
•
Design and run tests for the future reporting tools.
•
Possible revisions/adjustments to the improved reporting tools.
▪
▪
▪
Performing the internal EEA function of “data custodian” involving the maintenance of
databases, developing and updating automated QA scripts, data harvesting scripts and
IT dimensions of updating the website European Industrial Emission Portal.
Ensuring that confidentiality, data protection and IT security protocols are maintained
to the standards required by the EU Institutions.
Ensuring a secure access and use of the data that are marked as confidential, in
accordance with Article 4 of Directive 2003/4/EC
51
. These data shall neither be
publically available nor accessible (directly or indirectly).
o
1 CA “Member State and stakeholder support”. Objective:
to support Member States on
the day-to-day proceedings of data submission, quality checking of systematic aspects and
validation of submissions and other assitance functions to reporters and the general public.
The agent would achieve the following tasks:
▪
Performing the Seveso helpdesk function to assist Member States in their reporting.
▪
Complement automated quality checks by also manually checking reports before their
harvesting into the master database to systematically ensure basic data quality.
▪
Production of extracts and basic database analysis upon demand by the European
Commission’s services, the Member States and other stakeholders.
▪
Assistance to feeding content from Seveso eSPIRS into the European Industrial
Emission Portal through its Content Management System (CMS).
▪
Supporting publications and strategic communication, dissemination and outreach
activities (webinars, web visibility) on its practical/technical aspects.
-
Thematic staff agents for for eSPIRS and eMARS:
2 full-time equivalent temporary agents
(AD TA) at the EEA (average cost EUR 199 576/year) for the thematic and analytic tasks linked
to eSPIRS and eMARS:
51
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environmental information
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o
1 AD TA “Subject matter expert – eSPIRS Seveso reporting”. Objective:
to lead the
EEA activities relating to eSPIRS and ensure close links with other EEA activities on zero
pollution and reporting streams under environment law on industrial emissions. It will fulfill
the following tasks:
▪
Overall coordination for the eSPIRS dataflow between Member States (function defined
at the EEA as “reporters”) and the EEA (function defined in EEA as “data steward”).
These duties include:
•
Supervising the development of improvement on the eSPIRS reporting tools by
providing the necessary thematic (expert) perspective.
•
Capacity building and support to the reporters in countries.
•
Quality assuring reports from countries.
▪
Analysing country data and the resulting European dataset to extract intelligence on the
distribution of establishments relevant in terms of industrial accidents, cross-checking
those with other aspects of industrial activities regulated by EU law (e.g. Industrial
Emission Directive, greenhouse gas emission trading scheme).
▪
Contributing to the dissemination of the reported information in the European Industrial
Emission Portal, and ensuring relevant information is also used for assessment activities
in line with the Agency’s support to the European Commission on Zero Pollution.
▪
Liaising with the European Commission services and the Expert Groups and
Committees relevant to the Seveso Directive.
▪
Attending scientific meetings related to the subject matter and other networking
activities that can contribute to the uptake and use of the reported information in relevant
Fora.
o
1 AD TA “Subject matter expert – eMARS Seveso reporting”. Objective:
to lead the
EEA activities relating to eMARS and ensure close links with other EEA activities on zero
pollution and reporting streams under environment law on industrial emissions. It will fulfill
the following tasks:
▪
Overall coordination for the eMARS dataflow between Member States (function
defined at EEA as “reporters”), the JRC and the EEA (function defined in EEA as “data
steward”). These duties include:
Supervising the development of improvement on the eMARS reporting tools by
providing the necessary thematic (expert) perspective.
•
Capacity building and support to the reporters in countries to define the
requirements of the improved tools, train them in their use and assist the
interpretation of the requirements.
•
Quality assuring reports from countries.
Analysing country data and the resulting European dataset to extract intelligence and
lessons learned on industrial accidents covered by the Seveso Directive, cross-checking
those with other aspects of industrial activities regulated by EU law (e.g. Industrial
Emission Directive, greenhouse gas emission trading scheme) .
To follow up on reported accidents throught the life cycle of their cases, improving the
information stored in the database until the conclusion of the case.
To ensure confidentiality, personal data protection and IT security standards are met
given the sensitive character of these information exchanges and thus keeping systems
at a state-of-the art level.
•
▪
▪
▪
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▪
▪
▪
▪
To ensure a secure access and use of the data that are marked as confidential, in
accordance with Article 4 of Directive 2003/4/EC
52
. These data shall neither be
publically available nor accessible (directly or indirectly).
Contributing to the dissemination of the reported information in the European Industrial
Emission Portal, and ensuring relevant information is also used for assessment activities
in line with the Agency’s support to the European Commission on Zero Pollution.
Liaising with the European Commission services and the Expert Groups and
Committees relevant to the Seveso Directive.
Attending scientific meetings related to the subject matter and other networking
activities that can contribute to the uptake and use of the reported information in relevant
Fora.
Summary of additional resource needs for the Commission implementing decision (EU) 2022/1979
under the SEVESO directive:
Agency
EEA
Summary of tasks
Operation of database of industrial plants
falling under the scope of Seveso III
Directive
Operation of database of industrial major
accidents
Resource needs
Financial resource needs:
2023:
EUR 335 000
2024:
EUR 330 000
2025:
EUR 70 000
2026:
EUR 70 000
2027:
EUR 70 000
2023:
3 TA, 1 CA
2024:
3 TA, 1 CA
2025:
3 TA, 1 CA
2026:
3 TA, 1 CA
2027:
3 TA, 1 CA
Human resource needs:
Future budget line: DG Environment
Candidate for fees: No
5.
B
ATTERIES
R
EGULATION
(
PROPOSAL
)
Responsible body:
Currently: N/A, no current process for hazardous substances
(Re-)attribution planned to: ECHA
Legal basis for reattribution:
proposal for a Battery Regulation (revision of Battery Directive).
Type of task:
New
Brief task overview:
Under the proposal for a new Batteries Regulation, a task to prepare, on the
request of the Commission, a restriction dossiers for substances in batteries and for the RAC and
SEAC committees to provide an opinion would be given to ECHA. In addition, ECHA would prepare
a mapping study by 31/12/2026 on substances of concern present in batteries or used in their
manufacturing, in order to assist the Commission to prepare such report to the European Parliament
and Council by 31/12/2027.
Detailed process description:
Current process:
N/A, no process exists at EU level
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New process:
1. If the Commission considers that the use of a substance in the manufacture of batteries, or the
presence of a substance in the batteries when they are placed on the market, or during their
subsequent life cycle stages, including the waste phase, poses a risk to human health or the
environment that is not adequately controlled and needs to be addressed on a Union-wide basis,
it shall request the European Chemicals Agency (the ’Agency’) to prepare a dossier that
conforms to the requirements of point (3) of Part II of Annex XV to Regulation (EC) No
1907/2006 (‘restriction dossier’). The restriction dossier shall include a socio-economic
assessment, including an analysis of alternatives.
2. The Agency shall publish without delay the intention of the Commission to initiate such
restriction process life cycle for a substance, and shall inform stakeholders concerned.
3. Within 12 months of the receipt of the request from the Commission in paragraph 1 and if the
restriction dossier prepared by the Agency pursuant to that paragraph demonstrates that action
is necessary on a Union-wide basis, the Agency shall suggest restrictions in order to initiate the
restriction process described in paragraphs 4 to 14.
4. The Agency shall make publicly available on its website the restriction dossier, including the
restrictions suggested pursuant to paragraph 3, without delay, clearly indicating the date of
publication. The Agency shall invite all interested parties to submit individually or jointly,
within four months of the date of publication, comments on the restriction dossier.
5. Within 12 months of the date of publication referred to in paragraph 4, the Committee for Risk
Assessment (RAC), set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006, shall
adopt an opinion as to whether the suggested restrictions are appropriate in reducing the risk to
human health and/or the environment, based on its consideration of the relevant parts of the
restriction dossier. This opinion shall take account of the restriction dossier prepared by the
Agency at the request of the Commission, and the views of interested parties referred to in
paragraph 4.
6. Within 15 months of the date of publication referred to in paragraph 4, the Committee for Socio-
economic Analysis (SEAC), set up pursuant to Article 76(1)(d) of Regulation (EC) No
1907/2006, shall adopt an opinion on the suggested restrictions, based on its consideration of
the relevant parts of the dossier and the socio-economic impact. Prior to that, it shall prepare a
draft opinion on the suggested restrictions and on the related socio-economic impact, taking
account of the analyses or information according to paragraph 4, if there are any.
7. The Agency shall publish the draft opinion of the Committee for Socio-economic Analysis on
its website without delay and invite interested parties to provide their comments on the draft
opinion no later than 60 days from the publication of that draft opinion.
8. The Committee for Socio-economic Analysis shall without delay adopt its opinion, taking into
account where appropriate further comments received by the deadline set in paragraph 7. This
opinion shall take account of the comments of interested parties submitted under paragraphs 4
and 7.
9. Where the opinion of the Committee for Risk Assessment diverges significantly from the
restrictions suggested, the Agency shall postpone the deadline for the opinion of the Committee
for Socio-economic Analysis by a maximum of 90 days.
10. The Agency shall submit to the Commission without delay the opinions of the Committees for
Risk Assessment and Socio-economic Analysis on the restrictions suggested pursuant to the
request made by the Commission under paragraph 1. Where the opinions of the Committees for
Risk Assessment and Socio-economic Analysis diverge significantly from the restrictions
suggested pursuant to paragraph 3, the Agency shall submit an explanatory note to the
Commission providing a detailed explanation of the reasons for such differences. If one or both
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of the Committees do not adopt an opinion by the deadline set in paragraphs 5 and 6 the Agency
shall inform the Commission accordingly, stating the reasons.
11. The Agency shall publish the opinions of the two Committees on its website without delay.
12. The Agency shall provide the Commission on request with all documents and evidence
submitted to or considered by it.
13. If the Commission concludes that the conditions laid down in Article 6(2) are fulfilled, it shall
adopt a delegated act pursuant to Article 6(2). This delegated act shall be adopted without undue
delay following the receipt of the opinion of the Committee for Socio-economic Analysis
referred to in paragraph 8 or after the deadline set out under paragraphs 6 and 9, as applicable,
if that Committee does not adopt an opinion.
14. Where the Committees for Risk Assessment and Socio-economic Analysis provide an opinion
pursuant to paragraphs 5 and 6, they shall make use of rapporteurs as specified in Article 87 of
Regulation (EC) No 1907/2006. The rapporteurs or co-rapporteurs concerned, or their employer,
shall be remunerated by the Agency in accordance with a scale of fees to be included in the
financial arrangements related to restrictions established by the Management Board, set up
pursuant to Article 76(1)(a) of Regulation (EC) No 1907/2006. Where the persons concerned
fail to fulfil their duties, the Executive Director of the Agency has the right to terminate or
suspend the contract or withhold remuneration
Proximity to ECHA mandate:
The battery restriction process, although not identical, is very similar
to the REACH restriction process and the same scientific methodologies can be applied. The
substances under scrutiny are the same or similar to those under REACH and REACH (and other
ECHA) data and processes can be reused for battery restriction dossier development and opinion
forming. ECHA holds the right competences to manage the battery restriction process, however, does
not have sufficient information on the exact use of substances in batteries, which is to be remedied
with a study to be commissioned.
Projected synergies and added value of reattribution:
Type
Reuse of
capabilities
Synergy
High
Process and expertise: ECHA already supports similar work
on substance restrictions under REACH and other
legislation. Several key capacities can be reused/reinforced:
-
-
-
Hazard, risk, exposure and socio-economic
assessment
Committee opinion development
Existing IT capabilities for authority dossier
submission, stakeholder consultation and
dissemination
Re-use of
data
Workload
balancing
Medium
Reuse of substance identification and hazard data collected
under other chemical legislation. Currently low availability
of data on substances in products and waste streams.
With an estimated workload of one new restriction every
year, the workload of Agency experts and Committee
experts can be spread and balanced over the years (although
resource estimates are already annualised).
Reuse of IT capabilities for case management, public
consultation, interaction with Member States, regulatory
78
Medium
IT tools:
automation
High
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and
economies of
scale
Support
services:
economies of
scale
High
intentions management and data dissemination.
Reuse of scientific support services (e.g. committee
secretariat, prioritisation and grouping of substances,
substance identification, data management and
dissemination). Reuse of administrative services.
Type
Scientific
consistency
Added value
High
Opportunity to align priority setting, timeline, process and
methodology with other related legislation to improve
coherence in the scientific advice provided to the
Commission. Reuse of assessment insights developed under
other chemical legislation.
Centralising the scientific assessments on chemicals in one
EU agency and stricter separation between policy and
scientific advice adds more scientific robustness to the
process.
ECHA and its committees work under strict conflict of
interest avoidance rules, improving guarantees of
independent scientific advice to the Commission.
ECHA’s involvement will bring transparency to the process:
-
-
-
-
-
Overall process transparency
Publication of regulatory intentions of EU authorities
improves predictability for industry stakeholders
Public consultation/call for evidence
Stakeholder involvement/observer status
Dissemination of scientific data and outcomes
Robustness of
assessment and
acceptance
Independence
High
High
Transparency
High
Main risks and opportunities:
No major concerns and there are certainly opportunities to find
synergies with the REACH restriction process.
Projected impact on ECHA
-
ECHA Committees/bodies:
medium impact.
The task generates medium impact on the setup /
organisation / staffing of Committees/bodies due to the additional workload.
RAC
# of
rapporteur Type of
opinions
opinion
per year
Restriction
dossier
-
1
RAC
member
SEAC
# of
opinions
per year
1
rapporteur
Type of
opinion
SEAC
member
ECHA data model and IT infrastructure:
low impact.
The task can be implemented with
adjustments / configuration of existing data structures and IT systems
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-
ECHA key experts:
medium impact.
The task partly relies on existing expert competencies
which are limited within ECHA and also critical to REACH/CLP/BPR
regulatory tasks
Projected workload and resource implications:
Current workload and resource use:
N/A, no current process exists at EU level
Future workload and resource needs:
A total of 2 new full-time equivalent temporary agent staff (AD 5-7) at ECHA (average cost EUR
171 000/year with coefficient for FI and annual indexation over 4 years and beyond) will be needed
to make sure that sufficient resources would be earmarked for regulating the necessary battery related
substances without competing with REACH priorities. This covers an average of one additional
restriction (or other risk management measure) yearly, including risk assessment of lead in lead-acid
batteries, and of mercury and cadmium used in electric vehicle batteries.
In addition, 1 full-time equivalent contract agent staff for 3 years (CA FG III, average cost EUR 91
000/year with coefficient for FI and annual indexation over 3 years), will be necessary to increase the
knowledge base and carry out a mapping of substances of concerns used in batteries, facilitating an
informed priority setting and work plan establishment. This will be based on a mapping study to build
ECHA’s current knowledge on how the battery industry manages its hazardous chemicals to identify
relevant substances for regulatory risk management in the future. The study is estimted at EUR 400
000 (over 3 years) to outsource part of such research needs.
A sum of EUR 22 000 is also required to cover the cost of the rapporteurs (Member State experts
guiding the dossiers through the opinion-making in the RAC and SEAC committees) for each
restriction, as well as EUR 43 000 over 4 years for covering a proportionate part of the full cost of
organising the RAC and SEAC meetings (travel, accommodation and daily allowance costs: cost
calculated based on the average time/effort needed for a restriction dossier in both committees).
The aforementioned resources have been estimated using a calculation model which takes account of
relevant experience from tasks executed by ECHA under other regulatory frameworks (e.g. REACH,
CLP, BPR) and from the implementation of the existing national approaches where relevant. It sets
out the resources that will be needed by ECHA over 2024-2027 and beyond, in order to handle the
foreseen tasks.
Summary of additional resource needs for the batteries regulation:
Agency
ECHA
Summary of tasks
Assessment underlying the restriction of
hazardous substances in batteries (1 restriction /
year)
-
Substance prioritisation and data
analytics
-
Restriction dossier development
-
RAC opinion development
-
SEAC opinion development
-
Dissemination
Resource needs
Financial resource
needs:
2023:
EUR 158 000
2024:
EUR 158 000
2025:
EUR 158 000
2026:
EUR 25 000
2027:
EUR 25 000
2028:
EUR 25 000
2023:
2 TA, 1 CA
2024:
2 TA, 1 CA
2025:
2 TA, 1 CA
2026:
2 TA, 0 CA
2027:
2 TA, 0 CA
2028:
2 TA, 0 CA
Human resource
needs:
Future budget line: DG Environment
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Candidate for funding from fees: No
6.
E-PRTR R
EGULATION
(2006/166)
Responsible body :
Currently: N/A, no current process as it is expansion of the existing task performed by EEA
(Re-)attribution planned to: EEA
Legal basis for reattribution:
Revision of the EPRTR regulation (166/2006)
Type of task:
new (extension of the existing one)
Brief task overview:
EEA currently operates the European Pollutant Release and Transfer Register.
The existing EPRTR is replaced by an Industrial Emissions Portal that should be operated by EEA
too. The new Portal should contain more data and provide more functionalities as compared to the
old EPRTR. The Portal should provide information on emission for more substances, for more
installations and for more activities. It should also provides information on the use of water, energy
and raw materials by the concerned installations to allow monitoring of progress towards a circular,
highly resource-efficient economy.
Proximity to EEA mandate:
The operation of the Industrial Emission Portal fits well within the
mandate of EEA. EEA already operates the existing EPRTR and the new Portal has evolved from the
EPRTR.
Projected synergies and added value of (re-)attribution:
Type
Reuse of
capabilities
Synergies
High
Process and expertise: EEA already operates EPRTR, manages
reporting flows from installations and Member States and manages
related environmental information on air quality and water quality.
Several key capacities can be reused and further developed.
Reuse of data collected under other environmental legislation (air
and water) can be combined.
The existing IT capabilities can be partly reused.
Re-use of data
High
IT tools:
High
automation
and economies
of scale
Support
services:
economies of
scale
High
Reuse of support services for reporting and data management.
Reuse of administrative services.
Main risks and opportunities:
N/A
Projected impact on EEA:
•
•
EEA Committees/bodies:
no impact.
The task does not require involvement of EEA
Committees/bodies
EEA data model and IT infrastructure:
high impact.
The task requires adjustment of data
structures and IT systems and their long term operation
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•
EEA key experts:
low impact.
The task can utilise existing expert competences.
Projected workload and resource implications
Current workload and resource use:
N/A, no current process as it is an extension of the existing one.
Future workload and resource needs:
EEA costs include cost of 2 additional FTE (2 TAs) who will establish the IT infrastructure for
collecting new data fields (on resource use and additional pollutants), modify and expand the XML
schema to enable reporting at installation level and for newly captured agro-industrial activities,
update the Manual for Reporters to ensure consistent returns by operators/MS, run training sessions
for MS reporters to introduce these new requirements, and subsequently manage the reporting and
related dataflow. Costs of developing IT infrastructure will go down in the 3rd year, as only the IT
infrastructure maintenance costs will remain. It’s assumed that for the first two years EEA will need
more financial resources to revamp the existing tools as a result of the legal proposal.
EEA staff will establish the IT infrastructure that will be required to implement the proposed revisions
and subsequently manage the reporting and related dataflow. These IT enhancements relate to the
physical capacity of the reporting stream (i.e. number and nature of reports) and the supporting
systems (guidance, training etc.) to ensure their consistent application by industrial operators and
Member States.
Summary of additional resource needs for E-PRTR regulation:
Agency
EEA
Summary of tasks
•
Establishing and operating the IT
infrastructure for collecting new data
fields
•
Updating the manual for reporters
•
Run training sessions for MS reporters
Resource needs
Operational resource
needs:
2024:
EUR 170 000
2025:
EUR 70 000
2026:
EUR 30 000
2027:
EUR 30 000
2024:
2 TAs, 0 CA
2025:
2 TAs, 0 CA
2026:
2 TAs, 0 CA
2027:
2 TAs, 0 CA
Human resource
needs:
Budget line: DG Environment
Candidate for fees: No
7.
I
NDUSTRIAL
E
MISSIONS
D
IRECTIVE
(2010/75/EU)
Responsible body:
Currently: N/A, no current process
(Re-)attribution planned to: ECHA
Legal basis for reattribution:
Revision of the Industrial Emissions Directive (2010/75/EU)
Type of task:
new
Brief task overview:
ECHA has already for some time provided input to the Commission to the
review of the Best Available Techniques Reference documents (BREF). Now ECHA's role has been
formalised as part of this revised proposal. Overall, ECHA’s role would include routine support to
BREF/BAT and support to design/ implementation of the Chemicals Management System (CMS)
methodology.
Detailed process description:
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Current process:
N/A, no process exists at EU level
New process:
While ECHA has already done some work in this area, the Commission has now proposed giving
ECHA a formal role in drawing up BAT reference documents (BREFs).
The role of ECHA would be to ensure that:
•
An appropriate identification (and if necessary selection) of relevant substances for each
sector/BREF is made. This will include a characterisation of the uses of those substances by
sectors covered by BREFs including definition of best practices to use the safest alternatives
on the market. This will improve clarity and consistency of the various legislations (IED,
REACH, CLP)
The correct terminology is used in the BREF processes (e.g. substance, process chemical, raw
material)
The chemicals-related BATs (such as substitution techniques) are technically sound
Background documents, for Kick off Meeting and final meeting, drafted by the EIPPCB are
relevant regarding chemicals issue
Assistance is provided to the EIPPCB to access the information on ECHA’s database
Assistance is provided to answer stakeholders questions or comments where a chemicals
expertise is needed
•
•
•
•
•
The Commission would facilitate this work by organising an exchange of information between the
concerned industries, Member States, NGOs and ECHA. In addition, by 2024, ECHA should start
building a methodology for on-site risk assessment to actively manage input chemicals and resulting
emissions.
In short ECHA's new tasks would include the following:
•
Data mining of ECHA databases and generating a list of hazardous substances potentially
used in BREF sectors; extract substance-related information (regulatory status, classification,
substance identity), characterise the uses of those substances by sectors covered by BREFs
including definition of best practices to use the safest alternatives on the market, and provide
technical support to BREF revisions (TWG meetings, review, other technical inputs).
Develop guiding principles for the Chemicals Management System focussing on data
structure and methodologies for a site inventory of chemicals (substances and mixtures)
associated with further development of a site-level risk assessment methodology and
contribute to the development of guiding principles on how to conduct a comparative risk
assessment between the substances an operator uses for his processes/products and potential
alternatives.
•
Proximity to ECHA mandate:
This new task would mainly be the formalisation of a task already
performed by ECHA on an ad hoc basis, with the addition of support to design/ implement the CMS
methodology.
Projected synergies and added value of reattribution:
Type
Reuse of
capabilities
Synergies
High
Process and expertise: ECHA already provides scientific advice on
chemical substances and as it has supported related ad hoc advice
requests in the past, it already has the needed expertise. Several key
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capacities can be reused/reinforced:
-
-
Re-use of data
Workload
balancing
High
Medium
Hazard, risk and exposure assessment
IT capabilities for stakeholder consultation and
dissemination
Reuse of data collected under other chemical legislation, especially
also on substances in products via the SCIP database.
With occasional requests, the workload of Agency experts can be
balanced (although resource estimates are already annualised).
Not an IT-intensive process, but reuse of IT capabilities for case
management, public consultation, interaction with Member States
and data dissemination.
Reuse of scientific support services (e.g. prioritisation and grouping
of substances, substance identification, data management and
dissemination). Reuse of administrative services.
IT tools:
High
automation
and economies
of scale
Support
services:
economies of
scale
High
Type
Scientific
consistency
Added value
High
Opportunity to align priority setting, timeline, process and
methodology with other related legislation to improve coherence in
the scientific advice provided to the Commission. Reuse of data
collected under other chemical legislation.
Centralising scientific work from dispersed Commission services to
one central EU Agency and its experts.
Moving scientific work from dispersed Commission services to
experts in the European Chemicals Agency with a stricter
separation between science and policy. ECHA experts work under
stricter conflict of interest avoidance rules, improving guarantees of
independent scientific advice to the Commission.
ECHA’s involvement will bring additional transparency to the
process:
-
-
-
-
Overall process transparency
Public consultation/call for evidence
Stakeholder involvement
Dissemination of scientific data and outcomes
Robustness of
assessment and
acceptance
Independence
High
High
Transparency
High
Main risks and opportunities:
N/A
Projected impact on ECHA:
•
ECHA Committees/bodies:
no impact.
The task does not require involvement of ECHA
Committees/bodies
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•
•
ECHA data model and IT infrastructure:
no impact.
The task does not require adjustment of
data structures and IT systems
ECHA key experts:
high impact.
The task heavily relies on expert competencies, which are
limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks
Workload and resource implications:
Current workload and resource use:
N/A, no current process
Future workload and resource needs:
ECHA costs include cost of new 3 FTEs, who
•
will do the data mining of ECHA databases and generate a list of hazardous substances
potentially used in BREF sectors; extract substance-related information (regulatory status,
classification, substance identity), characterise the uses of those substances by sectors covered
by BREFs including definition of best practices to use the safest alternatives on the market,
and provide technical support to BREF revisions (TWG meetings, review, other technical
inputs) – 2 FTE
Develop guiding principles for the Chemicals Management System focussing on data
structure for a site inventory of chemicals (substances and mixtures) associated with further
development of a site-level risk assessment methodology and contribute to the development
of guiding principles on how to conduct a comparative risk assessment between the substances
an operator uses for his processes/products and potential alternatives - 1 FTE
•
In total, 3 TA posts
Summary of additional resource needs for industrial emissions directive:
Agency
ECHA
Summary of tasks
•
Mining of ECHA databases and generate a
list of hazardous substance potentially
used in BREF;
•
Extract substance-related information,
characterise the uses
•
Technical support to BREF revisions
•
Develop guiding principles for the
Chemicals Management System
•
Contribute to the development of guiding
principles on how to conduct a
comparative risk assessment
Resource needs
Operational resource
needs:
2024:
EUR 0
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2024:
3 TAs, 0 CA
2025:
3 TAs, 0 CA
2026:
3 TAs, 0 CA
2027:
3 TAs, 0 CA
Human resource
needs:
Future budget line: DG Environment
Candidate for fees: No
8.
E
NVIRONMENTAL
Q
UALITY
S
TANDARD
D
IRECTIVE
(2008/105/EC) + W
ATER
F
RAMEWORK
D
IRECTIVE
(2000/60/EC) + G
ROUNDWATER
D
IRECTIVE
(2006/118/EC)
Responsible body:
Currently: Commission with the support of the SCHEER committee, JRC and consultants
(Re-)attribution planned to: ECHA and EEA
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Legal basis for reattribution:
revision of Environmental Quality Standard Directive (2008/105/EC),
Ground Water Directive (2006/118/EC) and Water Framework Directive (2000/60/EC) + Omnibus
regulation.
Type of task:
Existing + new
Brief task overview
1. Assessments underpinning amendment of priority list of substances and derivation of
Environmental Quality Standards under EQS Directive;
2. New legal task: EU-wide EQS for substances listed in a (new) Annex II of the EQSD including
the so-called ‘River Basin Specific Pollutants’ (two per year); EU-wide threshold values for
groundwater pollutants (one per year) to be included in Annex II GWD
3. Assessment underpinning review of Annexes I and II of the Groundwater Directive;
4. Technical and scientific work related to amendment of ‘watch list’ and coordination of ‘watch
list’ activities both under EQS and Groundwater Directives.
Detailed process description:
Current process
Summary process description
Surface water:
Watchlist and priority list work currently done by JRC and after that a SCHEER opinion. IA of EQS
proposals for new substances on the Priority Substance (PS) list outsourced to contractor. For future:
Risk Assessment Committee (RAC) not needed for identification of substances for monitoring (watch
list). ECHA involvement lighter, but heavier for 6y priority setting, including RAC.
-
Watch List: identifying new substances for and removing substances from the Watch List
(amendment needed every 2 years (EQSD Article 8b(2)). The Commission is considering
moving to a three-year review cycle)
o
Proposals for adding and removing substances (including mixtures): usually ca. 10
substances / mixtures on watch list (based on literature overviews, information
resulting from other legislation)
o
Establishment/identification of the related PNECs. No RAC involvement.
o
Verification of the suitability and availability of monitoring and analytical methods
not entailing significant costs, and compilation of information on these for Member
States;
Issue is often absence of monitoring methods, otherwise nothing can be monitored.
ECHA to check availability and suitability of tests. This work we haven’t done much
in the past. Registrants have to supply appropriate analytical methods for their
substances, follow-up more now. ECHA could run a consultation to identify available
analytical methods. However, ECHA does not have the expertise to also test their
suitability, so it would preferably outsource such task to a scientific institute.
o
Assessment of monitoring results in view of identifying the need for setting EU wide
or national EQS (based on importance, frequency, impact of exceedances)
-
Priority List: technical work on reviewing the PS list (six-year review cycle; through delegated
acts)
o
Prioritisation work
o
Establishment of EQSs for new (groups of) PS or trigger values for (effect-based)
groups of PS
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o
Development of a final proposal (on new and revised PS/PHS, EQS), supported by an
opinion from the Risk Assessment Committee (RAC) and from the Committee for
Socio-Economic Assessment
o
Regular discussion and presentation in the WG Chemicals or related subgroup
-
New 1 (similar to current task 2 under GWD): EU-wide EQS for substances listed in a (new)
Annex II of the EQSD including the so-called ‘River Basin Specific Pollutants’ (RBSP)
formerly part of the ‘ecological status’ component of surface water status. The intention is
that MS will apply the listed EQS (rather than national EQS) if they identify the substances
as posing a risk; MS will be asked to upload/send these national EQS for uploading in the EU
wide Repository to be established by ECHA; this will enable ECHA to assist EC in prioritising
RBSPs for which the largest divergences have been identified without those being justified;
and develop the EU-wide EQS; the latter would be adopted through delegated acts; timeline:
one EQS per year, adoption by delegated act every six years. Difference with EU EQS for
priority substances apply in all cases, i.e. the substances are prioritised because of their overall
EU concern; for EQS for RBSPs, MS should in principle establish themselves EQS whenever
an RBSP is of national/local concern; but even for these, where it appears that divergences
are too wide between MS without this being justified; there is a need to set EU wide EQS, to
be applied however only when there is a national or local issuer
New 2: identification of suitable monitoring methods for monitoring and analysis of PFAS,
by 2 years after entry into force and for microplastics (2 years) and Antimicrobiotical
resistance genes (AMR) (2 years).
-
Groundwater:
Groundwater: no JRC involvement currently, most work done by Member State expert group and
contractor and outcome sent to SCHEER
-
-
-
Specific technical work on six-yearly reviewing the pollutants and quality standards in Annex
I
New: Six yearly review of list of pollutants in Annex II for which MS must consider setting
national thresholds if there is a local/regional/national problem (difference with Annex I
which relates to pollutants of EU wide concern)
New: develop/identify EU wide threshold values for pollutants currently covered by a national
threshold value (in Annex II), where necessary to ensure better and more harmonised
implementation: one per year, threshold values to be adopted by delegated act once every six
years
In summary, review of the pollutants listed in the two annexes and of the quality standards in
Annex I and development of EU wide threshold values for pollutants listed in Annex II.
proposals for the amendment of Annexes I and II, based on scientific and technical evidence;
Development of proposals for the amendment of Annexes I and II, based on scientific and
technical evidence; Opinion development via the RAC and SEAC committee; regular
presentation and discussion in the WG Groundwater.
New: mandatory Watch List:
o
Proposals for adding and removing substances
o
Verification of the suitability and availability of monitoring and analytical methods
not entailing significant costs, and compilation of information on these for MS
o
Development of the related PNECs. No RAC involvement
New: identification of suitable monitoring methods for monitoring and analysis of PFAS, by
2 years after entry into force and for microplastics (2 years) and Antimicrobiotical resistance
genes (AMR) [2 years].
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Detailed description of current process
Amendment of the list of priority substances for surface waters and development of Environmental
Quality Standards (EQS), including designation of Priority Hazardous Substances (from Water
Framework Directive (2000/60/EC) and its daughter directive EQS Directive (2008/105/EC) as
amended by 2013/39/EU):
•
•
The amendment (and associated technical and scientific work) is initiated by the Commission.
Consultant and/or JRC prioritises substances to be included in the list of priority substance (PS-
list) using a combination of monitoring-based approach and modelling-based approach, including
the results of the watch-list monitoring. Their work is regularly discussed in a sub-group of the
CIS WG Chemicals known as the Sub-Group on Review (SG-R) of the PS list. The outcome is a
ranking of substances based on their potential risks. (~ REACH prioritisation of candidate
substances for further risk management)
Consultant and/or JRC reviews the existing PS-list with a view to determine whether some should
be taken off the PS-list. A document has been drafted identifying potential criteria for removing
substances, considering that even if existing PS no longer pose a risk, removing them could result
in them again becoming a risk, unless their use has been banned.
Commission (DG ENV) in consultation with WG Chemicals selects substances for which EQS
are derived and which of the listed substances should be designated as priority hazardous
substances.
Commission (consultants, JRC) or volunteer Member States derive EQS for newly selected PS
(groups of PS), and review EQS for existing PS if new data are available. The work is organised
in subgroups for specific substances, led by the consultants, JRC or volunteer Member State
experts and are also discussed in WG Chemicals, subject to public open and targeted consultation
and specific technical workshops with experts under the IA support contract. (~derivation
of/proposal for Exposure Limits) (~stakeholder and public consultation) (~Adaptation to
Technical Progress)
Commission consults SCHEER on EQS derivation. (~RAC opinions)
Consultants prepare an impact assessment study of listing of a substance in the PS-list. (~Socio-
economic Assessment – SEAC opinion)
Commission makes a proposal for listing the substances in the PS-list and for setting EQS values.
The proposal goes through the ordinary legislative procedure.
Updated Annexes are published by the Commission.
•
•
•
•
•
•
•
Review and amendment of the surface-water watch-list (from EQS Directive (2008/105/EC) as
amended by 2013/39/EU):
•
•
•
The amendment (and associated technical and scientific work) is initiated by the Commission.
Consultant and/or JRC performs prioritisation exercise. EQSD Article 8b(1) specifies the
information to be taken into account. It is important to have an estimate of the PNEC (~derivation
of PNEC) and to ensure that an adequately sensitive analytical method is available.
JRC reviews the existing watch-list with a view to taking substances off the list. The substances
can only stay on for up to 4 years, but if sufficient high-quality monitoring data are obtained
sooner, they should be removed (~hazard assessment?) (~proposal for identification of candidate
substances).
The review of the watch-list is carried out in consultation with WG Chemicals.
The Commission adopts a new watch-list in the form of an Implementing Act subject to agreement
in the WFD Regulatory Committee.
Member States performs the monitoring and report data to EEA.
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•
JRC analyses the monitoring data whether there is an EU-wide risk.
Review of Annexes I and II and Voluntary groundwater watch-list (from Ground water directive
(2006/118/EC)):
•
•
The amendment (and associated technical and scientific work) is initiated by the Commission
under its legal obligation (GWD art. 10). This was initiated after the WFD fitness check
conclusions (2019), but technical works of the watch list started already in 2015.
Commission and CIS WG Groundwater consultant with the technical and scientific support of the
specific subgroup collects data and prioritises substances to be included in the annexes using an
agreed methodology (2018). These are included in a ‘List facilitating the review’. (When there
are insufficient monitoring data, substances are proposed for the voluntary watch-list).
Prioritization and selection process involves several steps, and relies upon aggregate data from
national entities across Europe on substance occurrence in groundwater, as well as available data
on substance persistence, mobility, toxicity, and bioaccumulation behaviour. The work is
regularly shared with CIS WG Chemicals and JRC.
Based on updated monitoring data, the consultant reviews the existing voluntary watch-list and
list facilitating the review with a view of adding substances to the lists. Outcomes are provided to
Commission and shared/discussed with WG Groundwater experts.
Commission proposes substances for potential inclusion in the two annexes. These are also
considered in the Impact Assessment (IA) Support Study policy options and corresponding
economic analysis (consultants).
Commission (JRC or consultant) propose potential quality standards for newly proposed
substances for Annex I and II. These are also shared with WG Groundwater experts, subject to
public open and targeted consultation and specific technical workshop with groundwater experts
under the IA support contract.
The Commission consults the SCHEER on selection of substances and the derivation of EU
quality standards (also consulting whether any of the proposed substances should be considered
for Annex II, in which case MS are to derive threshold values).
Consultants carry out an impact assessment support study of policy options that consider listing
substances in Annex I (with EU quality standard) or Annex II.
Commission makes a proposal for listing the substances in Annex I of the Groundwater Directive
(and EU quality standards if proposed for Annex I) or for adding substances in Annex II. The
proposal for Annex I goes through the ordinary legislative procedure; the proposal for Annex II
goes through ‘comitology: regulatory procedure with scrutiny’ (last review took place in 2014).
Updated Annexes are published by the Commission.
•
•
•
•
•
•
•
Additional details for the voluntary groundwater watch list mechanism (progresses and outcomes
regularly shared with WG Chemicals and JRC).
•
•
•
•
•
Consultant and group of volunteers within CIS WG Groundwater performs prioritisation exercise
(groups of substances), collects data and runs agreed methodology.
Consultant reviews the existing voluntary watch list and list facilitating (substances with enough
monitoring information that can be proposed for the GWD Annexes review) with a view adding
substances to the lists.
The review of the voluntary WL list and list facilitating is carried out in consultation with the
group of volunteers (within WG Groundwater).
The Commission agrees (Water Directors acknowledge) on a new voluntary watch list. The
Commission considers list facilitating for the formal process of the GWD Annexes review.
Member States perform monitoring on voluntary basis for the watch list and list facilitating
substances and report data to consultant. For quality standards and threshold values MS report on
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•
pollutants causing failure and risk, exceedances and trends (among other) though established
WFD reporting system.
Consultant assesses data provided on voluntary basis. EEA analyses the reported monitoring data
under WFD scheme.
Changes envisaged as part of reattribution: Yes
-
-
-
-
In the past only voluntary watch list under groundwater directive. Obligatory watch list would
be new.
New legal task: EU-wide EQS for substances listed in a (new) Annex II of the EQSD including
the so-called ‘River Basin Specific Pollutants’;
New legal task: EU wide threshold values for pollutants listed in Annex II GWD (where too
wide divergences exist between national standards);
Explicit identification, within 2 years of entry into force, of suitable monitoring methods for
monitoring and analysis of PFAS, and for microplastics and Antimicrobiotical resistance
genes (AMR)[2 years], for both SW and GW (in addition to the regular verification of the
suitability and availability of monitoring and analytical methods not entailing significant costs
for substances proposed to be listed in the Watch Lists under both directives)
Groundwater Directive: verification of the suitability and availability of monitoring and
analytical methods not entailing significant costs, and compilation of information on these for
MS. This task existed, but was never performed.
-
Proximity to ECHA mandate:
The works seems close to the ECHA core mandate, especially for
the EQSD / priority setting. ECHA already has the required expertise/competence for deriving EQSD
(PNECs).
Projected synergies and added value of reattribution:
Type
Reuse of
capabilities
Synergies
High
Process and expertise: ECHA already supports similar work on
substance restrictions, including safe limit value setting under
REACH and other legislation. Several key capacities can be
reused/reinforced:
-
-
-
Re-use of data
Workload
balancing
High
Medium
Hazard, risk, exposure and socio-economic assessment
Committee opinion development
IT capabilities for stakeholder consultation and
dissemination (including regulatory intentions)
Reuse of data collected under other chemical legislation.
With work culminating in 3 and 6-year cycles, the workload of
Agency experts and Committee experts can be balanced (although
work will be permanently ongoing and resource estimates are
already annualised).
Not an IT-intensive process, but reuse of IT capabilities for case
management, public consultation, interaction with Member States,
regulatory intentions management and data dissemination. ECHA is
also requested to build an EU repository of health limit values,
including EU and national EQS, building further on existing tools.
90
IT tools:
High
automation
and economies
of scale
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Support
services:
economies of
scale
High
Reuse of scientific support services (e.g. committee secretariat,
prioritisation and grouping of substances, substance identification,
data management and dissemination). Reuse of administrative
services.
Type
Scientific
consistency
Added value
High
Opportunity to align priority setting, timeline, process and
methodology with other related legislation to improve coherence in
the scientific advice provided to the Commission. Reuse of data
collected under other chemical legislation.
Insourcing of scientific work from consultants and dispersed
Commission services to one central EU Agency and its experts.
Involvement of RAC and SEAC committees adds more scientific
robustness to the process.
(See also
European Court of Auditors: External consultants at the
European Commission - Scope for reform).
Robustness of
assessment and
acceptance
High
Independence
High
Moving scientific work from consultants and dispersed
Commission committees to Agency experts and well-established
committees in the European Chemicals Agency with a stricter
separation between science and policy. ECHA and its committees
work under stricter conflict of interest avoidance rules, improving
guarantees of independent scientific advice to the Commission.
ECHA’s involvement will bring additional transparency to the
process:
-
-
-
-
-
Overall process transparency
Publication of regulatory intentions of EU authorities
improves predictability for industry stakeholders
Public consultation/call for evidence
Stakeholder involvement/observer status
Dissemination of scientific data and outcomes
Transparency
High
Main risks and opportunities:
The scope of EQSD / priority setting includes all chemicals, also
pesticides, pharmaceuticals, etc. ECHA will need to see how it collects data on pesticides and
pharmaceuticals in practice.
Projected impact on ECHA:
•
ECHA Committees/bodies:
high impact.
The task generates major impact on the setup /
organisation / staffing of Committees/bodies due to the additional workload. The committees
expertise is adequate. No new expertise of the committee is needed.
RAC
# of
rapportuer Type of
opinions
opinion
per year
SEAC
# of
opinions
per year
rapporteur
Type of
opinion
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GWD Annex I
GWD Annex
II
EQSD Annex
I
EQSD Annex
II
•
•
1
1
4
1
ECHA
ECHA
ECHA
ECHA
1
1
4
1
ECHA
ECHA
ECHA
ECHA
ECHA data model and IT infrastructure:
low impact.
The task can be implemented with
adjustments / configuration of existing data structures and IT systems
ECHA key experts:
high impact.
The task relies on existing expert competencies, which are
limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks
Projected workload and resource implications
Financial resource needs
Human resource needs
Candidate for funding from fees?
Approximately: 11 FTEs
No
Current workload volume and resources spent in Commission
In summary the current resources spent are:
Current budget line
JRC + JRC consultants for EQS surface water
and Watch List surface water
DG ENV consultants for impact assessment for
EQS surface water
DG ENV consultants for voluntary watch list
groundwater
SCHEER Committee members + external
experts
Budget line of DG ENV (+JRC) + budget line of
DG SANTE
Ca. 4.5 FTE (1 FTE regular JRC staff + 3.5 FTE
contracted by EUR 232 030 per year)
Ca. 0.25 FTE (contracted by EUR 16 700 per
year)
Ca. 0.16 FTE (contracted by EUR 10 560 per
year)
Ca. 30% of work time (average over all the
years) of SCHEER membership
•
EUR 79 200 for reimbursement (30% of
EUR 240 000) or up to EUR 93 134 for
the year at the peak
Ca. 1.00 FTE (ca. 30% of work time (average
over all the years) of 2 + 1 FTE)
Total
Ca. 6.00 FTE
(to convert the cost of consultants into FTEs, the cost of 1 FTE consultant is estimated at ca. EUR
66 000 EUR annually)
Such Commission resources do not include contributions to the administrative overhead of the
Commission (HR, Finance, IT tools, etc.).
Past workload for EQSD (surface water) (Budget line of ENV and SANTE)
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Watchlist surface water:
-
Review of ca. 10 substances / every 2 years
Prioritisation and EQS derivation
The Priority List went from 33 to 45 substances in 2013 and will grow with an additional 22
substances in 2022. From that list the SCHEER provided opinions on a total of 45 EQS during the
last 10-12 years (average of 4 EQS per year) as follows:
2022: EQS for 14 priority substances + 4 pending + groundwater standards pending for
several substances
•
2021: EQS for 3 priority substances
•
2012: EQS for 1 substance
•
2011: EQS for 23 substances
Also, if one looks at the last 6-year review cycle in 2022 when 22 substances were added to the
Priority List, one comes to an average of 4 substances per year if the workload needs to be annualised.
Past workload for groundwater:
In the past only voluntary watch list under groundwater directive. Obligatory watch list would be
new, align two directives. Currently only 2 pharmaceuticals for EU standard and 1 for MS monitoring.
A few substances will be added in 2022.
Resources used currently for EQSD (surface water):
Watchlist and derivation of EQS for new Priority (hazardous) substances is currently led by JRC (in
house and contractors) and the list of P(H)S and related EQS are submitted to a SCHEER opinion.
SCHEER has delivered 45 opinions in the period between 2011 – 2022 (average of 4/year). IA of
EQS proposals for new substances on the PS list outsourced to contractor; regular discussion and
presentation in Working Group Chemicals.
JRC staff permanent+ JRC consultant work Watch List and Annex I EQS list PS and EQS = EUR 1
392 181 (AAs with JRC) over 6 years, i.e. EUR 232 030 per year; if we calculate yearly consultant
cost at EUR 66 000, this would make
ca 3.5 FTE plus 1 FTE
(one permanent staff)/year.
In addition, part of the impact assessment was carried out under IA contract DG ENV = relevant part
of IA contract was about EUR 100 000; i.e. Ca. 1.5 FTE over six years =
0.25 FTE
per year
The SCHEER Committee serves water legislation for approximately 1/3
rd
of its capacity (17 opinions
out of 51 during 2016-2022). SCHEER has 17 (external) scientists per mandate that are remunerated
for their work. DG SANTE provides the secretariat to the SCCS and SCHEER that consists of 4 FTE
+ 2 FTE for technical and administrative support (literature search, editing and proofreading of
opinions, website mastering, assistance for the Health-EU newsletter, dissemination activities).
Costs
for renumeration of members of the committee are ca. EUR 93 134 per year
(30% of 310 447,08
(the total cost of SCHEER activities in 2019 consisting of indemnities, travel cost and daily
allowances for the members).
The total resources used: 6.1 FTEs
(4.5 FTE/year (Scientific work) + 1.35 FTE/year (committee
secretariat) + 0.25 FTE/year (impact assessment via contract)) +
costs of renumeration of members
of the committee of ca. EUR 93 134 per year
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Resources used currently for GWD (ground water)
No JRC involvement currently, most work on voluntary watch list mechanism is done by MS expert
group and contractor; outcome of that work is sent to SCHEER for updating of Annex I; for the
current proposal of additional 4 groups of substances one single opinion was provided (one file
covering all pollutants).
DG ENV consultants for voluntary watch list groundwater = 4 low volume contracts at cost of EUR
57 000 = approximately 1 FTE over six years =
0.16 FTE
per year
In addition: contributions from MS; EC and JRC permanent staff (already estimated under ‘Surface
water’ and SCHEER opinion (one opinion on total amount of substances proposed for Annex I).
Future policy trends, workload drivers and ECHA resource needs
Commission’s calculation method:
If we estimate the additional cost of the new tasks introduced under the proposal, i.e. additional 2
EQS per year for Annex II EQSD and GWD and additional 1,5 substances/pollutants to be identified
per year for Watch List GW (proposed 5 substances every 3 years, i.e. 10 over six years i.e.
approximately 1.5 per year): so this would add up to approximately 35% of the current 6.26 FTE (4
opinions per year, plus Watch List with double amount of substances), i.e. in total 6.26 FTE plus 2.25
FTE which
would make approximately 8.5 FTE.
To compare this estimate of current expenditure with the proposal from ECHA we would need to add
the estimated amount for the development and/or identification of monitoring and analysis methods
for total PFAS (note that for microplastics and for AMR, since these will be part of the ‘normal’
Watch list mechanism, the identification of methodologies would supposedly be covered by the
normal ‘Watch list support’);
For JRC is currently working on a methodology for measuring microplastics in drinking water
(budget of EUR 300 000), to be adopted by delegated act in Jan 2024. A contract is being launched
for the development of technical guidelines on analytical methods for PFAS (mainly ‘PFAS Total’)
in drinking water (budget EUR 200 000); also to be established by Jan 2024. It is likely that the work
required for developing or identifying methodologies for microplastics and total PFAS in surface and
in groundwater bodies will benefit from the work carried out under the drinking water directive,
possibly resulting in slightly lower estimates.
ECHA’s calculation method:
The priority setting process is similar work to REACH Annex XIV prioritisation, while the setting of
EQS as well as reviewing the substances and quality standards in Annexes I and II to the GWD) is
assumed similar to deriving Occupational Exposure Limits (OELs), with an average cost in ECHA
of 0.7 FTE / substance. This however does not yet include the provision of a socio-economic analysis
/ impact assessment via the SEAC committee, which would add an additional 0.3-0.5 FTE (estimate
made in the past for possible socio-economic assessment work for OELs).
Also, the surface water and groundwater watchlist process, and especially the setting of PNECs, is
assumed similar to deriving OELs, with an average cost in ECHA of 0.7 FTE / substance. However,
this process would potentially not include committee opinion forming, so the cost is estimated to be
half lighter at 0.35 FTE / substance.
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Annual ECHA resource needs:
The following resource estimates correspond to the “ECHA way”, i.e. implementing similar
processes and similar level of digitalisation to what is in place for ECHA’s current tasks. Such
examples would be the creation of registries of intentions and the dissemination of lists (watch
lists, priority lists) as structured data. The benefit of this approach is to ensure a consistent
standard of scientific quality, transparency, data searchability and interoperability.
•
Both for Groundwater and surface water:
verification of the suitability and availability of
monitoring and analytical methods not entailing significant costs, and compilation of
information on these for MS:
0.5 FTE
for running a public consultation on available methods,
scientific support and contract management of the second part of the task to assess suitability
of analytical methods which would be outsourced to a scientific institute at ca. EUR 70 000
annually;
•
Identification of suitable monitoring and analytical methods for microplastics, PFAS and
AMR within two years after entry into force: resource needs covered under the bullet point
above;
•
Identifying and setting PNECs for 5
groundwater
watch list substances every 3 years:
0.5
FTE annually
(~unit cost of 1 ‘light’ OEL without committee involvement = 0.35 FTE);
•
Groundwater:
Specific technical work on six-yearly review of the pollutants and quality
standards in Annex I and possible updating of Annex II (listing pollutants for which MS must
set national thresholds) to the GWD: six year cycle review of the pollutants listed in the two
annexes and of the quality standards in Annex I. Development of proposals for the amendment
of Annexes I and II, based on scientific and technical evidence: review 1 substance annually:
1 FTE annually
(~unit cost of 1 OEL, incl. RAC + SEAC = 1 FTE);
•
Priority setting process
groundwater,
identifying substances where national thresholds apply
but wide divergences exist, identification of EU wide thresholds for pollutants in Annex II;
one per year, to be included in a delegated act every six years:
1 FTE annually
(~unit cost of
1 OEL, incl. RAC + SEAC = 1 FTE);
•
Identifying and setting PNECs for 10
surface water
watch list substances every 3 years:
1.05
FTE annually
(~unit cost of 1 ‘light’ OEL without committee involvement = 0.35 FTE);
•
Setting of EQS for Priority List substances for ca. 4
surface water
substances annually +
RAC committee opinion forming + SEAC committee opinion forming:
4 FTE annually
(~unit cost of 1 OEL, incl. RAC + SEAC = 1 FTE);
•
Technical work under
surface water
on establishing EU-wide EQS for substances listed in a
(new) Annex II of the EQSD including the so-called ‘River Basin Specific Pollutants’
formerly part of the ‘ecological status’ component of surface water status: assumption of
setting EQS for 1 substance per year:
1 FTE annually
(~unit cost of 1 OEL, including RAC
+ SEAC = 1 FTE);
•
IT tools and infrastructure development and run cost (data submission, processing, output):
contribution of 10% for common components and customisations;
•
Horizontal support (governance & enablers / administrative overhead): contribution of 15%.
-----------
Ca. 2.5 FTE for groundwater
Ca. 6.05 FTE for surface water
+ 0.5 FTE + 70k EUR for analytical methods for both groundwater and surface water
+ 10% IT tools and infrastructure (would be approximately 1 FTE)
+ 15% administrative overhead (would be approximately 1.5 FTE)
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--------
Total: ca. 11 FTEs
plus EUR 70 000 for outsourcing of identification of monitoring methodologies
Summary of additional resource needs for Environmental Quality Standard Directive
(2008/105/EC) + Water Framework Directive (2000/60/EC) + Groundwater Directive
(2006/118/EC):
Agency
EEA
Summary of tasks
Resource needs
Operational resource needs:
2024:
EUR 130 000
2025:
EUR 80 000
2026:
EUR 80 000
2027:
EUR 80 000
2024:
3 TAs, 0 CA
2025:
3 TAs, 0 CA
2026:
3 TAs, 0 CA
2027:
3 TAs, 0 CA
2024:
EUR 673 000
2025:
EUR 686 000
2026:
EUR 702 000
2027:
EUR 718 000
2024:
7 TAs, 4 CA
2025:
7 TAs, 4 CA
2026:
7 TAs, 4 CA
2027:
7 TAs, 4 CA
Human resource needs:
ECHA
Operational resource needs:
Human resource needs:
Future budget line: DG Environment
Candidate for fees: No
9.
CLP R
EGULATION
(1272/2008)
Responsible body:
Currently: N/A
(Re-)attribution planned to: ECHA, EFSA
Legal basis for reattribution:
Revision of the CLP Regulation
Type of task:
New
Brief task overview:
1. Developing a proposal for harmonised classification
2. Opinion on a proposal for harmonised classification
Detailed process description:
Current process:
For hazards of highest concern (carcinogenicity, mutagenicity, reproductive toxicity (CMR) and
respiratory sensitisers) and for other substances on a case-by-case basis, classification and labelling
should be harmonised throughout the EU to ensure an adequate risk management. This is done
through harmonised classification and labelling (CLH). Harmonised classifications are listed in
Annex VI to the CLP Regulation.
The process for harmonised classification is as follows:
i.
Member State (or industry under certain conditions) submits proposal for harmonised
classification to ECHA. There is no legal obligation to do this; it is at the MS’ (or
industry’s) discretion.
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ii.
iii.
iv.
RAC provides an opinion on harmonised classification.
ECHA sends opinion to COM
‘Where appropriate’, COM formalises classification through addition of substance to Annex
VI to CLP
Future process:
ECHA or EFSA, on the request of the Commission, will be obliged to develop a proposal for
harmonised classification.
Proximity to Agency mandate:
The task fits well with the mandates of ECHA and EFSA. Both
agencies are already involved in hazard and risk assessment of chemicals. ECHA already manages
the process of RAC opinion making on proposals for harmonised classification and other provisions
of CLP regulation.
Projected synergies and added value of reattribution:
Higher capacity to agree on harmonised
classification for substances and the possibility to solve divergent opinions among agencies as regards
hazard assessment is the key added value.
Type
Synergies
Reuse of
capabilities
High
Process and expertise: ECHA already supports work under the CLP
regulation including opinion making on harmonised classification and
performs risk and hazard assessment under other pieces of legislation.
Several key capacities can be reused/reinforced:
-
-
-
Hazard assessment
Committee opinion development
Existing IT capabilities for dossier submission, stakeholder
consultation and dissemination
Re-use of
data
Workload
balancing
IT tools:
automation
and
economies of
scale
Support
services:
economies of
scale
Medium
Low
High
Reuse of substance identification and hazard data collected under
other chemical legislation.
With an estimated workload of developing 5 proposals annually, there
is little room for workload balancing.
Reuse of IT capabilities for case management, public consultation,
interaction with Member States, regulatory intentions management
and data dissemination.
High
Reuse of scientific support services (e.g. committee secretariat,
prioritisation and grouping of substances, substance identification,
data management and dissemination). Reuse of administrative
services.
Type
Added value
Scientific
High
Opportunity to solve divergent opinions among agencies as regards
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consistency
hazard assessment.
Projected impact on ECHA and EFSA:
•
ECHA Committees/bodies:
high impact.
The task requires involvement of ECHA committee
RAC. EFSA Committees/bodies:
no impact.
No involvement of EFSA’s committees
RAC
# of
rapporteur Type of
opinions
opinion
per year
Harmonised
classification
•
6
ECHA staff
SEAC
# of
opinions
per year
0
rapporteur
Type of
opinion
ECHA data model and IT infrastructure:
low impact.
The task can be implemented with
adjustments / configuration of existing data structures and IT systems; EFSA data model and
IT infrastructure:
no impact.
The task does not require use of IT infrastructure.
ECHA key experts:
high impact.
The task relies on expert competencies, which are limited
in ECHA and also critical to other regulatory tasks. EFSA key experts:
high impact.
The task
relies on expert competencies, which are limited in EFSA and also critical to other regulatory
tasks.
•
Workload and resource implications:
Current workload and resource use:
Number of RAC opinions on harmonised classifications managed by ECHA varies per year, with an
average of 47 opinions per year:
Number of opinions per year
Opinions on
Classification (CLH)
2016
35
2017
33
2018
61
2019
51
2020
49
2021
53
Based on the analysis provided by ECHA (which was based on the analysis of ECHA and MSs
spending on preparation of classification dossiers), the dossier for harmonised classification which is
of average complexity requires 0,5 FTE and 95k EUR:
ECHA’s estimate of resources for supporting the preparation of a CLH dossier of medium complexity
estimate for CLH
Dossier development
0.35 FTE
RAC opinion making
0.1 FTE
Support services
0.05 FTE
Total FTE
0.5
95K EUR:
•
•
•
Title 1 Staff expenditure: EUR 85 000, including 19% overhead cost
Title 2 Infrastructure: included under Title 1 above
Title 3 Operational costs: EUR 10 000
The dossier of high complexity, requires 0.65 FTE and EUR 120 000:
ECHA’s estimate of resources for supporting the preparation of a complex CLH dossier
ECHA estimate for CLH
Dossier development
0.5 FTE
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RAC opinion making
Support services
Total FTE
0.1 FTE
0.05 FTE
0.65
EUR 120 500:
•
•
•
Title 1 Staff expenditure: EUR 110 500, including 19% overhead cost
Title 2 Infrastructure: included under Title 1 above
Title 3 Operational costs: EUR 10 000
The CLH dossier of low complexity requires 0.35 FTE and EUR 69 500
ECHA’s estimate of resources for supporting the preparation of a CLH dossier of low complexity
estimate for CLH
Dossier development
0.2 FTE
RAC opinion making
0.1 FTE
Support services
0.05 FTE
Total FTE
0.35
EUR 69 500:
•
•
•
Title 1 Staff expenditure: EUR 59 500, including 19% overhead cost
Title 2 Infrastructure: included under Title 1 above
Title 3 Operational costs: EUR 10 000
ECHA and EFSA do not prepare any proposals for harmonised classifications.
Future workload and resource needs:
Based on the impact assessment, it is expected that additional 250 dossiers will have to be prepared
over the next 20 years, i.e. 12.5 dossiers per year. It is expected that the dossiers to be prepared are to
be of lower complexity than medium, but higher than low complexity dossiers, i.e. having an average
resource requirement of 0.4 FTE per dossier. This would result in the need of 5 FTEs per year to
process 12.5 dossiers/year. Normally, there is a need for the contribution of 15% for the development
and maintenance of common IT components (0.75 FTE) and for the contribution of 15% for the
horizontal support (governance & enablers / administrative overhead) (0.75 FTE per year). However,
as this is an extension of existing CLH process in the agency and the process and structures are fully
in place, there is no need for these additional overhead contributions. Therefore, in total, there is a
need of
5 FTEs per year.
EFSA will need to prepare up to 1 dossier per year, which is possible to be absorbed by its resources
for the plant protection products.
Summary of additional resource needs for the CLP regulation:
Agency
ECHA
Summary of tasks
- Preparing classification dossiers (12.5 per
year)
- Assessing classification dossiers (13.5 per
year)
Resource needs
Financial resource
needs:
2024:
EUR 0
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2024:
3 TA, 2 CA
2025:
3 TA, 2 CA
2026:
3 TA, 2 CA
2027:
3 TA, 2 CA
2024:
EUR 0
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2024:
0 FTE
2025:
0 FTE
2026:
0 FTE
Human resource
needs:
EFSA
- Preparing classification dossier (1 per year)
Financial resource
needs:
Human resource
needs:
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2027:
0 FTE
Future budget line: DG GROW
Candidate for fees: No
10. P
ACKAGING AND
P
ACKAGING
W
ASTE
D
IRECTIVE
Responsible body:
Currently: N/A, no current process for hazardous substances
(Re-)attribution planned to: ECHA
Legal basis for reattribution:
revision of the Packaging and Packaging Waste Directive
(94/62/EC)
Type of task:
New – expanding the existing REACH restriction process and
Brief task overview:
Assessments underpinning restrictions of substances in packaging and
performing a scoping study for substances in packaging that would be candidates for restriction.
Detailed process description:
New process:
If there is a need to restrict a substance in packaging, restriction process under REACH shall be used
for that purpose.
The study will aim at collecting, identifying and prioritising relevant substances of concern in
packaging for which potential limitations or restrictions could be envisaged. This study will draw on
available information and registers covering substances of concern to enable an initial prioritisation
for swift further restriction action, as appropriate. This study, will determine the conditions under
which the concentration level of certain substances of concern, do not apply to recycled materials and
to product loops which are in a closed and controlled chain. It will also detail the reasoning of setting
exemptions from the requirements of the proposed regulation for certain types of packaging.
Proximity to ECHA mandate:
This task fits very well with the ECHA’s core mandate, as it is a
REACH restriction. ECHA holds the right competences to manage the packaging restriction process,
however, does not have sufficient information on the exact use of substances in packaging.
Projected synergies and added value of reattribution:
This reattribution ensures maximal synergies and coherence of scientific opinions. The same process
and the same scientific methodologies as in REACH will be used. The substances under scrutiny are
the same or similar to those under REACH (and other legislation supported by ECHA) and REACH
(and other ECHA) data and processes can be reused for packaging restriction dossier development
and opinion forming. All needed competencies for the task exist in ECHA.
Projected impact on ECHA
-
ECHA Committees/bodies:
medium impact.
The task generates medium impact on the
setup / organisation / staffing of Committees/bodies due to the additional use to be
considered in the restriction
RAC
# of
rapporteur Type of
opinions
opinion
per year
SEAC
# of
opinions
per year
rapporteur
Type of
opinion
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Restriction in
packaging and
packaging
waste
-
-
0
RAC
member
0
SEAC
member
ECHA data model and IT infrastructure:
low impact.
The task can be implemented with
adjustments / configuration of existing data structures and IT systems
ECHA key experts:
medium impact.
The task heavily relies on expert competencies, which
are limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks
Projected workload and resource implications
Current workload and resource use:
N/A, no current process for hazardous substances.
Future workload and resource needs:
It can be expected that at most 1 restriction of a substance will be needed once per two years, i.e. 0.5
restriction per year. This would require 0.5 FTE per year. In addition, there is a need for the
contribution of 15% for the development and maintenance of common IT components (0.1 FTE per
year) and for the contribution of 15% for the horizontal support (governance & enablers /
administrative overhead): (0.1 FTE per year). In total, there is a need of 0.7 FTE per year. Considering
the fact that these restrictions will be performed as REACH restrictions, possibly merging restriction
in packaging with restriction of the same substance in another uses, the work resources can be covered
by the available resources for REACH restriction.
The performing of the scoping study will require a dedicated person for 3 years to compile and analyse
the necessary information leading to the identification and prioritisation of substances that need to be
considered for the restriction in packaging. The work is the best to be performed by the large part by
the internal ECHA staff as the access to all information on chemicals and materials is needed. It is
estimated that 1 FTE for 3 years would be necessary to perform such study. Some subcontracting
may be possible to get more information on the insight of the use of chemicals in packaging.
Summary of additional resource needs for packaging and packaging waste directive:
Agency
ECHA
Summary of tasks
- Processing at most 0.5 restriction dossiers
per year (including RAC and SEAC opinion)
as part of REACH restriction
- Performing a scoping exercise related to
presence of chemicals in packaging
Resource needs
Financial resource
needs:
2024:
EUR 0
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2028:
EUR 0
2024:
0 TA, 0 CA
2025:
1 TA, 0 CA
2026:
1 TA, 0 CA
2027:
1 TA, 0 CA
2028:
0 TA, 0 CA
Human resource
needs:
Future budget line: DG Environment
Candidate for fees: No
11. L
EGISLATION ON MEDICINAL PRODUCTS FOR HUMAN USE
(726/2004)
Responsible body:
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Currently: EMA
(Re-)attribution planned to: EMA, expanding and modifying the existing tasks and adding new tasks
Legal basis for reattribution:
Proposal for a Directive of the European Parliament and of the Council on the Union code relating to
medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
(COM (2023) 192 final)
Proposal for a Regulation of the European Parliament and of the Council laying down Union
procedures for the authorisation and supervision of medicinal products for human use and establishing
rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and
Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No
141/2000 and Regulation (EC) No 1901/2006 (COM (2023) 193 final)
Type of task:
New and modified existing ones
Process description:
New/modified processes:
The details of the new and modified tasks are provided in the proposal for the directive
53
, the
regulation with accompanying legislative financial statement
54
and the accompanying staff working
documents
55,56,57
.
In short:
Specific objectives of the legislative proposals are:
1. Promote innovation, in particular for unmet medical needs, including for rare disease
patients and children.
2. Create a balanced system for pharmaceuticals in the EU that promotes affordability for
health systems while rewarding innovation.
3. Ensure access to innovative and established medicines for patients, with special attention to
enhancing security of the supply across the EU.
4. Reduce the environmental impact of the pharmaceutical product life cycle.
5. Reduce the regulatory burden and provide a flexible regulatory framework.
The main requirements of the proposals to be met in the short and long term are:
•
Upon the entry into force of the Regulation, the Agency should put in place the framework which
will be used to enhance regulatory support and accelerated assessment, to address medicine
shortages and supply chain challenges and to strengthen the environmental risk assessment under
the marketing authorisation.
Regarding the enhanced regulatory support, the Agency shall set up within 6 months of adoption
a coordination mechanism to enable parallel scientific advice with health technology assessment
and regulatory bodies for medical devices. Within the same period, the Agency shall create an
•
53
Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal
products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC (COM (2023) 192 final).
54
Proposal for a Regulation of the European Parliament and of the Council laying down Union procedures for the
authorisation and supervision of medicinal products for human use and establishing rules governing the European
Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing
Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 (COM (2023) 193
final).
55
EUR-Lex - 52023SC0191 - EN - EUR-Lex (europa.eu)
56
EUR-Lex - 52023SC0192 - EN - EUR-Lex (europa.eu)
57
EUR-Lex - 52023SC0193 - EN - EUR-Lex (europa.eu)
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Academia Office, a secretariat to support not-for-profit entities by providing them free of charge
early scientific advice. Furthermore, the Agency shall establish an EU inspectorate within the
Agency, to strengthen the network’s inspection capacity and deal with emergencies, similar what
was needed during the pandemic.
•
For addressing medicine shortages the Agency shall extend the monitoring and management
capacity for all shortages, with a focus on critical shortages, and extend the EMA capacity to
support would facilitate availability of critical medicinal products. This appropriate availability
and access to medicinal products which may have a serious impact on public health.
The Agency shall also extend its capacity to support the enhanced environmental risk
assessments.
•
The modified or new tasks that are related to the one substance, one assessment approach are:
•
•
developing coherent scientific assessment methodologies in the fields falling within EMA
mission;
cooperating with EU decentralised agencies and other scientific authorities and bodies established
under Union law, notably the European Chemicals Agency, the European Food Safety Authority,
the European Centre for Disease Prevention and Control and the European Environment Agency
as regards the scientific assessment of relevant substances, exchange of data and information and
development of coherent scientific methodologies, including replacing, reducing or refining
animal testing, taking into account the specificities of the assessment of medicinal products;
take the necessary and appropriate measures to monitor and identify at an early stage any potential
source of divergence between its scientific opinions and the scientific opinions issued by other
Union bodies and agencies carrying out similar tasks in relation to issues of common concern.
Where the Agency identifies a potential source of divergence, it shall contact the body or agency
in question to ensure that all relevant scientific or technical information is shared and in order to
identify potentially contentious scientific or technical issues. Where a substantive divergence over
scientific or technical issues is identified and the body concerned is a Union Agency or a scientific
committee, the Agency and the body concerned shall cooperate to resolve the divergence, and
inform the Commission without undue delay.
to enable coherence between scientific opinions and to avoid duplication of tests, EMA shall make
arrangements with other bodies or agencies established under Union law for cooperation on
scientific assessments and methodologies. EMA shall also make arrangements for the exchange
of data and information on relevant substances with the Commission, Member States’ authorities
and other Union Agencies, in particular for environmental risk assessments, non-clinical studies
and maximum residue limits. These arrangements shall seek to ensure that exchanges of data and
information are made available in electronic formats and shall protect the commercially
confidential nature of the information exchanged and be without prejudice to the provisions on
regulatory protection.
electronic applications for marketing authorisations and for variations to the terms of the
marketing authorisations shall be introduced to avoid unnecessary administrative and financial
burden both for the pharmaceutical industry and the competent authorities and EMA shall make
available such electronic formats.
EMA shall set-up an active substance based review system of environmental risk assessments
(‘ERA monographs’) for authorised medicinal products. An ERA monograph shall include a
comprehensive set of physicochemical data, fate data and effect data based on an assessment of
active substances.
103
•
•
•
•
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Proximity to Agency mandate:
The tasks fit well with the mandate of EMA as all three tasks target
the areas of the EMA mandate, and they are either an expansion of existing tasks or addition of new
tasks related to medicines.
Projected synergies and added value of reattribution:
Improving coherence, consistency and
interoperability among the Agencies work is the key added value.
Workload and resource implications:
Future workload and resource needs:
The new tasks require additional resources for EMA. The additional resource needs are mainly related
to additional tasks to be carried out by EMA in terms of providing scientific, administrative and IT
support in the following main areas:
•
•
•
•
•
•
enhanced pre-authorisation scientific and regulatory support;
decision-making on orphan designations and management of the Union Register of designated
orphan medicinal products;
active substance master file assessment and certification;
inspection capacities for inspections in third countries and support to Member States;
environmental risk assessment strengthening;
shortage management and security of supply.
As described in the legislative financial statement accompanying the proposals, the following
resources are needed:
•
6 FTEs (4 AD and 2 AST TAs) are necessary to set up the Academia Office at EMA that will
be managing the procedures. The tasks of the office will be similar to the tasks of the SME
office and will include procedural and administrative assistance to “not-for-profit” entities,
including direct assistance and briefing meetings on regulatory strategy, providing fee waivers
and reductions to eligible entities, provide free-of-charge translations of the product
information in all EU languages for initial EU marketing authorisations, provide training and
education to “not-for-profit” entities, etc
54 FTEs:
o
managing (AD profiles) and providing support (AST profiles) to operational expert
groups in the area of the Environmental Risk Assessment (ERA);
o
with a scientific and regulatory profile to work in the shortages management and
security of supply;
o
Good Manufacturing Practice and Good Clinical Practice inspectors (AD) necessary
to establish an EU inspectorate resourced by EMA staff that would provide help to the
inspections done by Member States (lacking resources), and deal with emergency
situations which require dedicated and dependable intervention (e.g., similar to
inspections required during the pandemic);
o
Legal officers (AD profiles), needed in the field of orphan designations that are already
today a litigious topic and so it is assumed the proposed changes in the decision
making on orphan designation would generate an increased in workload for even more
legal queries and litigations;
o
defining business requirements for the data register, following up on the
implementation and perform the related scientific activities when the register is live;,
develop trainings on ERA, etc.;
104
•
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o
providing administrative support to the operational expert groups;
o
working in the area of inspection planning;
o
general assistants, assistants, supporting on procedural aspects or working on
document creation.
Summary of additional resource needs for Medicinal Products Regulation:
Agency
EMA
Summary of tasks
See above
Financial resource
needs:
2024:
EUR 0
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2028:
EUR 0
2024:
19 FTE
2025:
37 FTE
2026:
52 FTE
2027:
60 FTE
2028:
60 FTE
Human resource
needs:
Future budget line: DG SANTE (EU4Health programme) + EMA fees
12. E
ND
-
OF
L
IFE
V
EHICLES
(ELV) D
IRECTIVE
Responsible body:
Currently: Commission with the support of consultants
(Re-)attribution planned to: ECHA
Legal basis for reattribution:
revision of the Directive on end-of-life vehicles (2000/53/EC)
Type of task:
Existing
Brief task overview:
1. Restriction of hazardous substances in end-of-life vehicles
2. Assessments underpinning review of exemptions from restriction on lead, mercury, cadmium,
or hexavalent chromium.
Detailed process description:
Current process:
The End-of-life Vehicle Directive bans the use of four heavy metals (lead, mercury, hexavalent
chromium and cadmium) in vehicles put on the EU market after 1 July 2003. More substances could
be prohibited, but in practice no substances have been added since the start of the directive. Annex II
to the Directive lists the exemptions which allow the use of one of these heavy metals in specific
applications where their use is “unavoidable”. The only criteria used is availability of alternatives.
Environmental and socio-economic aspects are not considered. The Commission reviews the
exemptions on a regular basis based on technical and scientific progress and as the dates of exemption
validity expire.
1. Restricting (uses of) hazardous substances in vehicles: (~ REACH restriction):
•
•
Has not happened since the initial four heavy metals were placed on Annex II.
2. Review of exemptions from the restrictions (~ REACH authorisation)
Two years before the expiry date of an exemption, the Commission contracts a consultant to
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•
•
•
•
review the existing exemptions. The contractor is used also for new exemptions. Next review
is in 2025.
Contractor makes a review of the exemption needs (example). The assessment focuses on
determining whether the use of the substances in applications listed in Annex II is avoidable.
The assessment includes stakeholder consultation.
Contractor concludes on whether the use of substances is avoidable and makes
recommendation to the Commission.
The Commission consults a Commission expert group on the proposal, including MS and
stakeholders.
The Commission drafts a delegated act, which is open for a 4-week commenting period, after
which it adopts the delegated act amending Annex II.
Changes in the process: Yes
As part of the revision of the directive, the following changes are envisaged.
The scope of the Directive will be extended (from passengers’ cars and light commercial vehicles) to
include also motorbikes, buses, lorries, etc. As a result, higher workload is expected in terms of
exemption requests.
Restricting (uses of) new hazardous substances in vehicles will be done via REACH regulation,
similarly as proposed for packaging and packaging waste directive.
ECHA will be tasked to assess the need for exemptions for existing restrictions (4 heavy metals).
The criteria for exemptions from restriction of 4 heavy metals will be amended to be similar to the
socio-economic assessment and analysis of alternatives performed under REACH. The only criterion
currently used is availability of alternatives. Environmental and socio-economic aspects are not
considered. This is criticised, so better alignment with assessments as done under REACH is
envisaged.
Restrictions of use of chemicals in batteries used in vehicles will not be within the scope of the
directive. This is to be addressed under the Batteries Regulation (as lex specialis).
Proximity to ECHA mandate:
All new restrictions of substances in vehicles will be done via the
restriction process under REACH and the existing scientific methodologies used for REACH
restrictions can be applied. The ELV exemption process will become very similar to the authorisation
process under REACH, including the criteria for assessment. The substances under scrutiny are the
same or similar to those under REACH and existing ECHA data and processes can be reused for ELV
restriction dossier development, exemption process and opinion forming. ECHA holds the
appropriate competences to manage the process, however, does not have sufficient information on
the exact use of substances in end-of-life vehicles.
Projected synergies and added value of reattribution:
Type
Reuse of
capabilities
Synergies
High
Process and expertise: ECHA already supports similar work on
substance restrictions and exemptions under REACH and other
legislation. Several key capacities can be reused/reinforced:
-
-
-
Re-use of data
Medium
Hazard, risk, exposure and socio-economic assessment
Committee opinion development
Existing IT capabilities for industry dossier submission,
stakeholder consultation and dissemination
Reuse of data collected under other chemical legislation, but low
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availability of data on substances in products and waste streams.
Workload
balancing
Medium
With an estimated workload of processing 5 exemption requests
annually, while developing one new restriction every 5 years, the
workload of Agency experts and Committee experts can be spread
and balanced over the years (although resource estimates are
already annualised).
Industry actors can submit their exemption requests reusing existing
ECHA submission tools, at the same time automating the existing
process. In addition, reuse of IT capabilities for case management,
public consultation, interaction with Member States, regulatory
intentions management and data dissemination.
Reuse of scientific support services (e.g. committee secretariat,
prioritisation and grouping of substances, substance identification,
data management and dissemination). Reuse of administrative
services.
IT tools:
High
automation
and economies
of scale
Support
services:
economies of
scale
High
Type
Scientific
consistency
Added value
High
Opportunity to align priority setting, timeline, process and
methodology with other related legislation to improve coherence in
the scientific advice provided to the Commission. Reuse of data
collected under other chemical legislation.
Insourcing of scientific work from consultants to Agency experts.
Additional involvement of RAC and SEAC committees adds more
scientific robustness to the process.
(See also
European Court of Auditors: External consultants at the
European Commission - Scope for reform).
Robustness of
assessment and
acceptance
High
Independence
High
Moving scientific work from consultants to Agency experts and
committees. ECHA and its committees work under strict conflict of
interest avoidance rules, improving guarantees of independent
scientific advice to the Commission.
ECHA’s involvement will bring additional transparency to the
process:
-
-
-
-
-
Overall process transparency
Publication of regulatory intentions of EU authorities
improves predictability for industry stakeholders
Public consultation/call for evidence
Stakeholder involvement/observer status
Dissemination of scientific data and outcomes
Transparency
High
Main risks and opportunities:
No major concerns and there are certainly opportunities to find
synergies with the REACH restriction process.
Projected impact on Agency:
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-
ECHA Committees/bodies:
medium impact.
The task generates medium impact on the setup
/ organisation / staffing of Committees/bodies due to the additional workload
RAC
# of
rapportuer Type of
opinions
opinion
per year
Restriction (as
part of
REACH)
Review of
exemption
0
RAC
member
-
SEAC
# of
opinions
per year
0
rapporteur
Type of
opinion
SEAC
member
SEAC
member
0
5
-
-
ECHA data model and IT infrastructure:
low impact.
The task can be implemented with
adjustments / configuration of existing data structures and IT systems
ECHA key experts:
medium impact.
The task partly relies on existing expert competencies,
which are limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks
Projected workload and resource implications:
Current workload and resource use:
No new substances were restricted since the adoption of the Directive (end 2000). 4 substances are
currently restricted. They were restricted as part of the adoption of the legal text end 2000.
There were 41 valid exemptions in May 2022. The number of exemptions assessed varies across the
years, with average 2.14 exemption assessment per year:
11
th
adaptation 2021 reviewed
9
th
and 10
th
adaptation 2019
8
th
adaptation 2016
7
th
adaptation 2015
6
th
adaptation 2012
4
th
and 5
th
adaptation 2010
3rd adaptation 2008
2nd adaptation 2007
1st adaptation 2004
Total
3 exemption requests reviewed
5 exemptions reviewed
3 exemptions reviewed
6 exemptions reviewed
1 exemption reviewed
12 exemptions reviewed
1 new exemption
11 exemptions reviewed
5 exemptions reviewed
47 assessments
(average of 2.14 assessments
annually over 22 years)
The Commission spends ca. 0,1 FTE within DG ENV for the hazardous substances in the ELV
Directive, plus a contract of 60.000 EUR every 2,5 years on average.
The summary of current resources spent is:
Ca.
0.1 FTE (dedicated to the work on
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DG ENV
DG ENV consultants
Total
hazardous substances)
Ca.
0.36 FTE (a contract of EUR 60 000 every
2.5 years for reviewing exemptions)
Ca.
0.46 FTE
(to convert the cost of consultants into FTEs, the cost of 1 FTE consultant is estimated at ca. EUR
66 000 annually)
Such Commission resources do not include contributions to the administrative overhead of the
Commission (HR, Finance, IT tools, etc.).
Current budget line: DG Environment
Future workload and resource needs:
New restrictions of substances in vehicles will be done in the future via restriction process under
REACH. The number of restrictions can be expected to be approximately 1 restriction per 5 years,
i.e. 0.2 restriction per year.
Assessment of the exemptions under the new REACH restriction will be done as part of the REACH
process and review of REACH restrictions.
Assessment and review of exemptions from existing restrictions for 4 metals (cadmium, mercury, led
and chromium VI) will be in the future done by ECHA with involvement of SEAC committee. The
assessment criteria will be extended as compared to today to be aligned with the criteria used under
the REACH authorisation process. The scope of the directive will be extended to cover more types
of vehicles, which will result in higher number of exemption requests as compared to today. The
number of assessments of exemption is expected to be double as compared to today, i.e. 4.28
assessments per year.
The ELV restriction process is to be similar to REACH restrictions, with an average cost in ECHA
of 1 (light) – 1.5 (complex) FTE per restriction dossier. The ELV restrictions are expected to be light
dossiers.
The exemption review process is assumed similar to REACH applications for authorisations (AfA =
0.15 (light dossier) – 0.3 (complex dossier) FTE per application. The ELV assessments are expected
to be light dossiers.
The resources needed for ECHA are as follow:
Development of 1 restriction dossier every 5 years (scope extension to new vehicle types)+
opinion forming: 0.2 FTE (~1 light REACH restriction = 1 FTE). However, considering that
these restrictions will be performed as REACH restrictions, these resources can be covered
by the available resources for REACH restriction. Therefore, for this part of work it is 0 FTE.
•
Review of up to 5 existing exemptions annually + SEAC opinion forming: 0.75 FTE (~unit
cost of 1 light REACH application for authorisation = 0.15 FTE)
•
Scientific support services: substance identification and prioritisation, data management and
dissemination: can be absorbed by the agency
•
IT tool development cost (data submission, processing, output): contribution of 15% for
common components (0.11 FTE)
•
Horizontal support (governance & enablers / administrative overhead): contribution of 15%
(0.11 FTE)
-----------
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Total: 0.97 FTE
Summary of resource needs for end-of-life vehicle directive:
Agency
ECHA
Summary of tasks
Preparation of 1 restriction dossier every 5
years
Assessment of up to 5 exemptions per year
Human resource needs:
Financial resource
needs:
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2028:
EUR 0
2024:
0 TA, 0 CAs
2025:
1 TA, 0 CAs
2026:
1 TA, 0 CAs
2027:
1 TA, 0 CAs
2028:
1 TA, 0 CAs
Future budget line: DG Environment
Candidate for funding from fees: Task 1 No, Task 2 yes
13. T
OY
S
AFETY
D
IRECTIVE
Responsible body:
Currently: Commission with the support of the SCHEER Committee
(Re-)attribution planned to: ECHA
Legal basis for reattribution:
revision of the Toy safety directive (2009/48/EC).
Type of task:
existing
Brief task overview:
1. Assessment underpinning establishing or strengthening chemical limit values in toys for
children under 36 months or toys for other children intended to be taken in the mouth;
2. Assessment underpinning amending the limit values for ‘heavy metals’ in toys;
3. Assessment underpinning amendments to the lists of allergenic fragrances that are prohibited
in toys or that have to be labelled if present in toys;
4. Assessment underpinning a derogation for the use of CMR substances in toys.
Detailed process description:
Current process:
Tasks 1, 2 and 3:
The process can be triggered by an expert of the subgroup Chemicals (which is a subgroup of the
Expert Group on Toys Safety (01360) consisting of experts from the Member States, EEA-EFTA
countries, the toy industry, the European consumer organisations ANEC) suggesting that a new or
strengthened limit value for a chemical substance is needed, for example due to new scientific
knowledge. Also a Scientific Committee opinion, such as from the Scientific Committee on
Consumer Safety (SCCS), may be a basis for the Commission services to propose a new/strengthened
limit value;
Once the process is triggered, the subgroup Chemicals discusses the possible occurrence of the
substance in toys, assesses the hazard, exposure and risk and recommends a limit value for toys below
which the substance presents no risk. In case of conflicting views in the subgroup Chemicals that
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cannot be resolved, the Commission asks the Scientific Committee on Health, Environmental and
Emerging Risks (SCHEER) to assess the hazard, exposure and risk, and to recommend a limit value
for toys that presents no risk.
On the basis of the above recommendation, the Commission services draft a Directive amending the
Toy Safety Directive, Appendix C. The draft Directive indicates in its recitals the occurrence of the
chemical substance and suggests test methods for the substance in toys and toy materials. The
Commission consults the proposal with the Expert Group on Toy Safety (consisting of experts from
the Member States, EEA-EFTA countries, Candidate Countries, Switzerland, the toy industry,
European consumer organisations (ANEC, BEUC), CEN, Cenelec, notified bodies). After the
consultation, the Commission adopts the proposal via the comitology procedure.
Task 4:
The process is usually triggered by a toy industry expert, suggesting a derogation to allow the
continued use of a CMR substance (Cat. 1A, 1B or 2) in toys. This occurs when a substance has been
newly classified as being CMR.
The subgroup Chemicals briefly discusses the derogation and the Commission services requests the
toy industry for an analysis of alternatives in the case substance is a CMR cat 1 A or 1B ( no analysis
is necessaryif the substance is Cat. 2).
The Commission services then mandate the SCHEER to assess the use of the CMR substance in toys.
To allow the Commission to grant a derogation, the SCHEER has to assess the use of the CMR in
toys as safe. The Commission services also check whether REACH does not prohibited the CMR
substance in consumer articles.
If the use of the CMR substance in toys is concluded by SCHEER to be safe, there is no prohibition
of the substance in the consumer articles under REACH and the industry provides the analusis of
alternatives when necessary, the Commission services draft a Directive amending the Toy Safety
Directive, Appendix A. Then the Commission consults with the Expert Group on Toy Safety and
adopts the proposal.
Changes envisaged as part of reattribution: Yes
With the revision, the Commission intends to introduce the following changes:
•
•
extending the generic assessment approach (automatic ban) to other hazard classes for the
most harmful chemicals such as endocrine disrupting chemicals;
the possibility to introduce specific limit values for new chemicals could be introduced in all
toys, and not only in toys intended for children under 36 months or to be put in the mouth, as
is the case today.
Transfer the risk assessment tasks from SCHEER committee to ECHA’s Committee for Risk
Assessment (RAC).
•
Proximity to ECHA mandate:
The task is closely related to ECHA’s core mandate and ECHA has
the needed data, competences and expertise to perform the task.
Projected synergies and added value of reattribution:
Type
Reuse of
capabilities
Synergies
High
Process and expertise: ECHA already performs similar work on
restrictions, derogations, setting of limit values and assessing socio-
economic impacts under REACH and other legislation. Several key
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capacities can be reused/reinforced:
-
-
-
-
Re-use of data
High
Hazard, risk, exposure and socio-economic assessment
Exposure limit value definition
Committee opinion development
Existing IT capabilities for industry dossier submission,
stakeholder consultation and dissemination
Reuse of data collected under other chemical legislation, especially
REACH & CLP and via the SCIP database, with a focus on CMRs
and Endocrine Disruptors.
With an estimated workload of 2 derogation requests and setting
limit values for 2 additional substances annually, the workload of
Agency experts and Committee experts can be spread and balanced
over the years (although resource estimates are already annualised).
Industry actors can submit their derogation requests reusing existing
ECHA submission tools, at the same time automating the existing
process. In addition, reuse of IT capabilities for case management,
public consultation, interaction with Member States, regulatory
intentions management and data dissemination.
Reuse of scientific support services (e.g. committee secretariat,
prioritisation and grouping of substances, substance identification,
data management and dissemination). Reuse of administrative
services.
Workload
balancing
Medium
IT tools:
High
automation
and economies
of scale
Support
services:
economies of
scale
High
Type
Scientific
consistency
Added value
High
Opportunity to align priority setting, timeline, process and
methodology with other related legislation. Reuse of data collected
under other chemical legislation to improve coherence in the
scientific advice provided to the Commission.
Insourcing of scientific work from consultants to Agency experts.
Centralising the scientific committees for assessing chemicals in
one EU agency and stricter separation between policy and scientific
advice adds more scientific robustness to the process.
(See also
European Court of Auditors: External consultants at the
European Commission - Scope for reform).
Robustness of
assessment and
acceptance
High
Independence
High
Moving scientific work from consultants to Agency experts and
from dispersed Commission committees to well-established
committees in the European Chemicals Agency with a stricter
separation between science and policy. ECHA and its committees
work under stricter conflict of interest avoidance rules, improving
guarantees of independent scientific advice to the Commission.
ECHA’s involvement will bring additional transparency to the
process:
112
Transparency
High
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-
-
-
-
-
Overall process transparency
Publication of regulatory intentions of EU authorities
improves predictability for industry stakeholders
Public consultation/call for evidence
Stakeholder involvement/observer status
Dissemination of scientific data and outcomes
Main risks and opportunities:
Methodologies would need to be aligned. Finally, the revision is an
opportunity to also streamline the process and align with similar processes under REACH.
Projected impact on ECHA:
•
ECHA Committees/bodies:
high impact.
The task generates major impact on the setup /
organisation / staffing of Committees/bodies due to the additional workload
RAC
# of
rapporteur Type of
opinions
opinion
per year
Assessments
under Tasks
1,2,3 or 4
•
•
4.2
RAC
member
SEAC
# of
opinions
per year
4.2
rapporteur
Type of
opinion
SEAC
member
ECHA data model and IT infrastructure:
low impact.
The task can be implemented with
adjustments / configuration of existing data structures and IT systems
ECHA key experts:
high impact.
The task heavily relies on expert competencies, which are
limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks
Projected workload and resource implications:
Current workload and resource use:
In 12 years (2010-2021), there were 10 opinions requested from SCHEER (and before from SCHER
and SCENIHR). These opinions were about 17 substances and dealt with setting or reviewing limit
values (3 opinions for 13 substances), 2 generic assessments and 2 derogations requests:
-
-
-
-
-
-
2021: limit values for 8 substances in squishy toys
2017: limit value for 1 substance
2016: 1 generic opinion
2015: limit value for 1 substance
2012: 3 opinions (including 2 limit values and 1 derogation)
2010: 3 opinions (including 1 limit value and 1 derogation request)
The secretariat of the scientific committees hosted by DG SANTE employs 4 FTE of DG SANTE
and 2 additional FTEs of external interim staff (for technical and administrative support like literature
search, editing and proofreading of opinions, website mastering, assistance for the Health-EU
newsletter, dissemination activities). The staff of 6 FTEs is equally split over two committees, which
means that 3 FTEs are used to support work of SCHEER. The workload of SCHEER dedicated to
support of toys safety directive amounts to 10% of its time, which makes 0.3 FTE.
The operational costs for two committees (that includes special indemnities, accommodation, daily
allowances, travel costs, reimbursement for rapporteurship, etc) operated by the Commission were
EUR 2 883 030 for 6 years (2016-2021), which makes it approximately EUR 240 000 per year per
committee. It must be noted that the operational costs in 2019 were EUR 340 000, which then went
down because of the pandemic measures. The workload of SCHEER dedicated to support of toys
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safety directive amounts to 10% of its time, which corresponds to operational costs of EUR 24 000
(or at higher level of 2019 to EUR 34 000).
The resource use can be summarized as follows:
DG GROW
DG SANTE SCHEER secretariat
SCHEER committee
Ca. 1 FTE (dedicated to the work on hazardous
substances)
Ca. 0.3 FTE (10% of workload of SCHEER
secretariat)
10% of membership capacity
Operation costs EUR 24 000/ year
Total
Ca.
1.3 FTE
(to convert the cost of consultants into FTEs, the cost of 1 FTE consultant is estimated at ca. EUR
66 000 annually)
Such Commission resources do not include contributions to the administrative overhead of the
Commission (HR, Finance, IT tools, etc.).
Future workload and resource needs:
With the revision, the Commission intends to introduce the following changes:
•
•
extending the generic assessment approach (automatic ban) to endocrine disrupting
chemicals;
the possibility to introduce specific limit values for new chemicals could be introduced in all
toys, and not only in toys intended for children under 36 months or to be put in the mouth,
as is the case today.
Furthermore, currently CMRs are still allowed in toys up to the relevant CLP concentration limits.
Beyond those, derogations can be requested. Only a few derogations were requested by industry in
the past. If the generic prohibition would be extended from CMRs to EDC (or maybe even other
hazard classes), then also new derogation requests could be expected, especially in the early years
when production processes have not yet been adapted and EDCs are still present in potentially quite
large amounts. Due to this, it can be reasonably expected that the workload for derogations will
multiply (assumption x10 in the first years), but still within reasonable limits (e.g. 2 requests annually
vs 2 requests in 10-12 years).
The main work related to limit value setting can be best compared to CLH work, which is currently
rated at 0.5 FTE per substance per year within ECHA.
The processing of derogation requests is assumed similar to REACH applications for authorisations
(AfA = 0.15 – 0.3 FTE / application).
The resource needs for ECHA would then be as follow:
•
•
•
Setting/reviewing limit values for 2 substances every year + scientific committee opinion
forming: 1.0 FTE annually (~unit cost of 1 CLH opinion = 0.5 FTE)
Restriction/prohibition of 1 substance or generic opinion development for 1
substance/subject every 5 years + scientific committee opinion forming: 0.3 FTE annually
(~unit cost of 1 REACH restriction = 1 – 1.5 FTE)
Review of 2 derogation requests annually + scientific committee opinion forming: 0.3 FTE
(~unit cost of 1 REACH application for authorisation = 0.15 – 0.3 FTE)
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Scientific support services: substance identification and prioritisation, data management and
dissemination: can be absorbed by the agency
•
IT tool development cost (data submission, processing, output): contribution of 15% for
common components (0.24 FTE)
•
Horizontal support (governance & enablers / administrative overhead): contribution of 15%
(0.26 FTE)
-----------
Total: 2 FTEs
Summary of resource needs for toy safety directive:
Agency
ECHA
Summary of tasks
Assessment underpinning chemical limit values
Assessment underpinning amending the limit
values for ‘heavy metals’ in toys;
Assessment underpinning amendments to the lists
of allergenic fragrances that are prohibited in toys
Assessment underpinning a derogation for the use
of CMR and EDs substances in toys.
Financial resource
needs:
2024:
EUR 0
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2028:
EUR 0
2024:
0 TAs, 0 CAs
2025:
2 TAs, 0 CAs
2026:
2 TAs, 0 CAs
2027:
2 TAs, 0 CAs
2028:
2 TAs, 0 CAs
•
Human resource
needs:
Future budget line: DG GROW
Candidate for fees: No
14. R
ESTRICTION OF
H
AZARDOUS
S
UBSTANCE
(R
O
HS) D
IRECTIVE
(2011/65/EU)
Responsible body:
Currently: Commission with the support of consultants
(Re-)attribution planned to: ECHA
Legal basis for reattribution:
Directive amending the RoHS Directive on reattribution of tasks to
ECHA
Type of task:
Existing
Brief task overview:
1. Assessments underpinning restrictions of hazardous substances in electrical and electronic
equipment (currently 10 restricted substances)
2. Review of applications for exemptions from the restrictions.
Detailed process description:
Current process:
RoHS restricts the use of hazardous substances in Electrical and Electronic Equipment (EEE). It
covers the placing on the market of articles. It does not cover the use of the substance during the
manufacture of them. The restricted substances are included in Annex II to the Directive. They are
identified in accordance with the criteria outlined in its Article 6(1) with priority given to substances
included in Annexes XIV or XVII to REACH, Substances of Very High Concern (SVHC) and
substances with detrimental effects on waste management. RoHS includes also provisions for
granting temporary exemptions for specific applications under certain conditions pursuant to
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Article 5. Applications exempted from the restrictions are included in Annex III and IV. The details
of the processes are:
1. Restricting hazardous substances in electrical and electronic equipment (similar to REACH
restriction):
•
•
•
•
•
The process is initiated by the Commission on its own initiative or following submission of
a proposal by MSs (Art 6(1)).
Consultants perform a prioritisation to select substances.
Consultants perform an in-depth assessment (determination of hazard profile + waste
management issues + also some basic socio-economic assessment; it includes consultation
of interested parties).
Consultants make a recommendation whether the substance should be listed.
The Commission drafts delegated act modifying Annex II (currently listing 10 substances
with their maximum concentration values).
2. Reviewing exemptions from the restrictions (similar to REACH authorisation)
•
•
•
•
Industry applies for the exemption (new, renewal or revocation). Exemptions are by
technical application.
Consultants evaluate the request for derogation and its justification vis-à-vis the conditions
provided in Article 5(1)(a). It includes consultation of interested parties.
Consultants make recommendation whether a derogation shall be granted (and for how
long).
The Commission adopts a delegated act modifying the Annexes III or IV.
Changes envisaged as part of reattribution: Yes
The Commission wishes to establish a Registry of intentions. It also wishes to address the current
criticism on the process with regard to lack of transparency, predictability of duration of the processes
and of the procedural steps, involvement of stakeholders, quality of the assessment process and
required time. Alignment with other chemicals legislation is also desired.
Proximity to agency’s mandate:
The RoHS restriction process, although not identical, is similar to
the REACH restriction process and the similar scientific methodologies can be applied. The RoHS
exemption process, although not the same, resembles the authorisation process under REACH. The
substances under scrutiny are the same or similar to those under REACH and existing ECHA data
and processes can be reused for RoHS restriction dossier development, exemption process and
opinion forming. ECHA holds the right competences to manage the process, however, does not yet
have sufficient information on the exact use of substances in electronic equipment.
Projected synergies and added value of reattribution:
Type
Reuse of
capabilities
Synergies
High
Process and expertise: ECHA already supports similar work on
substance restrictions and exemptions under REACH and other
legislation. Several key capacities can be reused/reinforced:
-
-
-
Re-use of
data
Medium
Hazard, risk, exposure and socio-economic assessment
Committee opinion development
Existing IT capabilities for industry dossier submission,
stakeholder consultation and dissemination
Reuse of substance identification and hazard data collected under
other chemical legislation. Currently low availability of data on
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substances in products and waste streams.
Workload
balancing
Low
With an estimated workload of processing 27 exemption requests
annually, while assessing one substance every year for the list of
restricted substances, there is little room for workload balancing (and
resource estimates are already annualised).
Industry actors can submit their exemption requests reusing existing
ECHA submission tools, at the same time automating the existing
process. In addition, reuse of IT capabilities for case management,
public consultation, interaction with Member States, regulatory
intentions management and data dissemination.
Reuse of scientific support services (e.g. committee secretariat,
prioritisation and grouping of substances, substance identification,
data management and dissemination). Reuse of administrative
services.
IT tools:
automation
and
economies of
scale
Support
services:
economies of
scale
High
High
Type
Scientific
consistency
Added value
High
Opportunity to align priority setting, timeline, process and
methodology with other related legislation to improve coherence in
the scientific advice provided to the Commission. Reuse of
assessment insights developed under other chemical legislation.
Insourcing of scientific work from consultants to Agency experts.
Additional involvement of RAC and SEAC committees adds more
scientific robustness to the process.
(See also
European Court of Auditors: External consultants at the
European Commission - Scope for reform).
Robustness of
High
assessment and
acceptance
Independence
High
Moving scientific work from consultants to Agency experts and
committees. ECHA and its committees work under strict conflict of
interest avoidance rules, improving guarantees of independent
scientific advice to the Commission.
ECHA’s involvement will bring additional transparency to the
process:
-
-
-
-
-
Overall process transparency
Publication of regulatory intentions of EU authorities
improves predictability for industry stakeholders
Public consultation/call for evidence
Stakeholder involvement/observer status
Dissemination of scientific data and outcomes
Transparency
High
Main risks and opportunities:
No major concerns and there are certainly opportunities to find
synergies with the REACH restriction/authorisation process.
Projected impact on agencies:
-
ECHA Committees/bodies:
high impact.
The task generates major impact on the setup /
organisation / staffing of Committees/bodies due to the additional workload. The major impact
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is on SEAC committee.
RAC
# of
rapporteur Type of
opinions
opinion
per year
Restriction
Exemptions
-
-
1
3
RAC
member
RAC
member
SEAC
# of
opinions
per year
1
30
rapporteur
Type of
opinion
SEAC
member
SEAC
member
ECHA data model and IT infrastructure:
low impact.
The task can be implemented with
adjustments / configuration of existing data structures and IT systems
ECHA key experts:
high impact.
The task heavily relies on expert competencies, which are
limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks. The end of life
of an electrical and electronic equipment is important in this work and the expertise will
need to be built in this area.
Projected workload and resource implications:
Current workload and resource use:
Currently, there are 10 restricted substances. When the first directive was adopted in 2003,
6 substances were restricted. The 2011 revision of the directive introduced an obligation on the
Commission to review and amend the list of restricted substances at the latest by July 2014 and
periodically thereafter. In the first review, the Commission with the help of a consultant assessed 5
substances out of which four were added to the list of restricted substances in 2015 (Recital 10). The
second review was launched in 2018 and assessed 7 substances (/groups), out of which 2 were
recommended to be restricted. They have not been added to the list yet, as for one substance there is
an assessment undergoing under the Stockholm Convention. Based on this information (12
substances (/groups) assessed in 12 years (2011 - 2023)), the current average workload can be
estimated to be as 1 assessment of a chemical per year.
The second review which assessed 7 substances was supported by an external consultant contracted
by DG ENV. The cost of the contract was ca. EUR 180 000 and it took 2 years. As the assessments
are to be done ca. every 5 years, this indicates the current resources used for external support to be
approximately 2.7 FTEs (EUR 180 000/66 000) for 7 substances for 5 years, i.e. 0.54 FTE annually.
There are 45 time-limited use exemptions (Annex III) and 48 exempted uses in medical devices or
monitoring and control instruments (Annex IV) as current number entries. Each number entry
however can cover several final applications, which can be categorised in different EEE categories
(Annex I). Depending on the expiry date, exemptions can have up to four sub-entries for four groups
of categories. By including these sub-entries, there are 238 valid exemptions (Status March 2023). In
addition, a handful of exemption requests were assessed but no exemption was granted due to failure
to meet the criteria.
The number of completed exemption evaluations, resulting in a published report, and the
corresponding amount of resources required for external support varied depending on the year (see
table below). Due to expiry dates of existing exemptions, there are many applications and evaluations
in certain years. On average, in the period between 2015 and 2022, there were 13.9 exemptions
evaluated per year.
2015
2016
2017
2018
2019
2020
2021
2022
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Number of exemptions
evaluated (date of
publication of study)
2
38
4
11
2
9
0
45
The number and complexity of exemptions requests increased over the years and it created a backlog
on evaluating exemption request and adopting respective individual delegated directives. The
corresponding resources spent for external support for assessments of exemption requests in the years
2017-2022 were ca. EUR 145 000 per year (on average), or ca. EUR 12 000 per exemption
assessment, or 2.2 FTEs per year (EUR 145 000/66 000) or 0.18 FTE per exemption assessment (EUR
12 000/66 000).
The current resources spent by the Commission can be summarized as follows:
Ca. 1.5 FTE (on average)
DG ENV (for overall RoHS implementation)
DG ENV consultants – support for restrictions
DG ENV consultants – support for exemption evaluation
Ca. 0.54 FTE annually (a contract of EUR 180 000 on
average each 5 years for reviewing restrictions)
Ca. 2.2 FTE annually (contract for EUR 145 000
annually (average from 2017-2022) for outsourcing the
technical evaluation of exemption requests)
(to convert the cost of consultants into FTEs, the cost of 1 FTE consultant is estimated at ca. EUR
66 000 annually)
It must be noted that these resource estimates do not include contributions to the administrative
overhead of the Commission (HR, Finance, IT tools, etc.). It must be also noted that the resources
spent by the Commission were not sufficient, leading to the accumulation of requests for exemptions
without processing them to the legal drafting (currently 61 exemptions pending) and the revision of
the restriction was delayed (the review not finalised although it has started in 2018). There were also
complaints about the quality and robustness of the assessments, the transparency of the process and
involvement of stakeholders.
Current budget line: DG Environment
Future workload and resource needs:
Restrictions can be proposed by Member States and Commission has a duty to periodically review
the list of restricted substances. It is expected that the number of restrictions and underlying
assessments will be the same as in the past,
i.e.
assessment of ca. 1 chemical per year.
Requests for exemptions are submitted by industry. As exemptions are time-bound, the workload
volume is determined by the number of exemptions already in place and new requests coming in.
When a new restriction is introduced, it leads temporarily to higher number of requests.
In the near future it is expected that the number of exemption requests will increase as compared to
the past because in the past one exemption, which can be relevant for different final applications, had
one expiry date regardless of their final application (e.g. in medical devices). With the introduction
of splitting exemption entries depending on their final application, one previous exemption entry can
have now several different expiry dates. That means, the number of exemption requests can be
multiplied provided there are different final applications and the industry is applying for renewal. In
addition, in order to narrow down the scope of exemptions, exemptions are more and more split in
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more specified sub-exemptions, which should narrow down the covered applications and allow more
specific decisions.
Not all exemptions are applied for renewal, but economic operators can submit also new exemption
requests. It is expected that in the period of 2024-2025 there will be ca. 30 exemption requests per
year to be evaluated – provided recommended exemptions with respective expiry date will be
included.
For the future, the Commission (and stakeholders) also wishes to improve the procedure as regards
transparency (establishment of a registry of intent), involvement of stakeholders, the level of scrutiny
by the experts, robustness of the advice, independence of the advice and ensuring coherence with the
assessments performed under the other pieces of legislation. This will increase the need for resources
per exemption as compared to the past, but it is inevitable to address the concerns raised by the
stakeholders and to ensure robustness and acceptance of the process.
To evaluate specific exemption requests, ECHA might still require external expertise from time to
time (e.g. for assessing specific information about electronics). At the beginning, the need for external
expertise may occur more frequently than at a later stage when experience has already been gained
(e.g. with re-occurring renewal requests). However, it is expected that consulting external experts
remains the exception. In addition, there will be a need to implement the procedure (e.g. by updating
the guidance document for applications for an exemption). These irregular tasks depend on needs at
that specific moment and they are predestined to be carried out by external consultants. In order to
allow such ad-hoc tasks in the future, an operational budget is needed.
The future RoHS restriction process is assumed to be similar to REACH restrictions, with an average
cost in ECHA of 1 (light dossier) – 1.5 (complex dossier) FTE / restriction dossier. As it is expected
that in average there will be a need for 1 restriction dossier per year and the restriction dossiers will
be likely light, it is estimated that there would be a need for additional 1 FTE per year.
The future process for assessing exemption requests is assumed to be similar to REACH applications
for authorisations (~ AfA = 0.15 (light dossier) – 0.3 (complex dossier) FTE / application). It is
expected that the RoHS exemption assessments are to require light assessment, thus 0.15 FTE per
application. In addition, it is expected that RAC is consulted in 10% of the exemption applications
and the work is estimated with 0.1 FTE per exemption. However, this additional resources for RAC
can be absorbed by the Agency as part of the synergies with other work. In combination with the
average of expected exemption requests (i.e. 30 exemptions per year), this would result in 4.5 FTEs
per year.
The following resource estimates correspond to the “ECHA way”, i.e. implementing similar processes
and similar level of digitalisation to what is in place for ECHA’s current tasks. Such examples would
be the creation of registries of intentions and the dissemination of lists (exemptions, restrictions) as
structured data.
•
Development of 1 restriction dossier annually + opinion forming by RAC and SEAC:
1
FTE
(~ unit cost of 1 REACH restriction = 1 (light) to 1.5 FTE (complex))
•
Review of 30 exemption applications annually + opinion forming of SEAC and for 10% of
cases also by RAC:
4.5 FTEs
•
Scientific support services: substance identification and prioritisation of candidate
substances, data management and dissemination: to be absorbed by the Agency
•
IT tool development cost (industry and authority data submission, processing, output):
contribution of 15% for development and maintenance of common components (0.8
FTE)
•
Horizontal support (governance & enablers / administrative overhead): contribution of 15%
(0.8
FTE)
•
Add-hoc support by external consultants (e.g. specific expertise):
EUR 66 000
in the first
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year and
EUR 33 000
in average in the following years.
Process
Tasks
-
-
-
-
-
-
-
-
-
-
-
-
Estimated workload
volume
Substance prioritisation and
data analytics
Restriction dossier
development (ECHA
secretariat)
Conformity check
Public/targeted consultation
Committee opinion
development (incl. support by
secretariat)
Data dissemination
Industry dossier intake
Completeness check
Public consultation
Committee opinion
development (incl. support by
secretariat)
Support COM during
adoption of the IA
Data dissemination
1 additional
restriction per year
ECHA resource need
Restriction of
substances in
electronic
appliances
7 FTEs
(including IT tool development
and administrative overhead)
Exemption
requests
30 exemption
requests / year
Summary of additional resource needs for restriction of hazardous substances (RoHS) directive:
Agency
ECHA
Summary of tasks
- restriction of substances in electronic and
electrical equipment (ca. 1 dossier per year)
- assessment of exemption request (30
assessments per year)
Human resource
needs:
Resource needs
Financial resource
needs:
2024:
EUR 0
2025:
EUR 66 000
2026:
EUR 33 000
2027:
EUR 33 000
2028:
EUR 33 000
2024:
0 TA, 0 CA
2025:
3 TA, 0 CA
2026:
4 TA, 3 CA
2027:
4 TA, 3 CA
2028:
4 TA, 3 CA
Future budget line: DG Environment
Candidate for fees: Yes, for assessment of exemptions
15. POP
S
R
EGULATION
(2019/1021)
Responsible body:
Currently: Commission with the support of consultants
(Re-)attribution planned to: ECHA, EEA
Legal basis for reattribution:
Omnibus regulation for reattribution of tasks
Type of task:
existing
Brief task overview:
1. Assessments underpinning setting concentration limit values for substances subject to waste
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management provisions as part of the review of Annexes IV and V of the POPs regulation
2. Receiving chemical monitoring data of POPs as part of the regular reporting under the POPs
regulation
Detailed process description:
Current process:
Task 1
For a substance added to Annex I (prohibition on manufacturing, placing on the market and use),
Annex II (list of substances subject to restrictions) and as appropriate also for substances in Annex
III (list of substances subject to release reduction provisions), limit values in Annex IV and V for
these substances contained in waste need to be set, in order to ensure the environmentally sound
management of waste consisting of or contaminated by this POP substance.
The concentration limit values set for waste containing POP substances directly affects the amounts
of the concerned waste stream that can potentially be recycled, rather than being disposed of; a stricter
limit value could even result in the cessation of recycling of the waste stream altogether. These limits
are also very important in determing the possible disposal routes for waste (e.g. disposal in non-
hazardous or hazardous waste landfills instead of incineration, admission in different types of
incineration or co-incineration facilities. All these have relevant economic consequences for
operators.
Two concentration limits are distinguished for POPs in waste:
•
Low POP concentration limit (Annex IV): defines the concentration limit above which POPs
content in waste shall be subject to destruction or irreversible transformation; this means the waste
cannot be recycled and disposal options are limited to certain treatments (possible exceptions can
be granted by Member States for certain wastes)
Maximum POP concentration limit (Annex V): defines the threshold above which no derogation
from the obligation to destroy or irreversibly transform the POP content can be granted
•
The need to act is triggered by inclusion of a substance in the Stockholm Convention, following which
the process is initiated by the Commission: approx. 2-3 substances are identified as POPs under the
Stockholm Convention every 2 years, but for the transposition into the POPs Regulation the
Commission acts in five year cycles due to the heavy ordinary legislative procedure to add substances
to Annexes IV and V of the POPs Regulation.
For existing limit values in Annex IV and V no standard review process exists, but the values need
to be kept up to date in view of scientific and technical progress and revision clauses contained in the
Regulation, for substances already listed, need to be observed.
Under the current practice, consultants perform a technical assessment (hazard, risk, socioeconomic
aspects) for setting concentration limit values of the substance(s) in waste. This includes:
•
•
Collection of data on hazard and risk of the substance: this is mostly taken from the Stockholm
Convention listing exercise of the substance;
Compilation of information for identification of presence and concentrations of the substance in
different waste streams, and on recycling and other waste treatment activities involving waste
containing this substance(s), followed by an analysis of the information. Starting from reported
uses of this substance in products and articles and their material flows this includes a targeted
stakeholder consultation (Member States and other relevant stakeholders in particular waste
operators and users of recycled materials)
Application of an existing risk assessment methodology plus a socio economic assessment (no
full socio-economic impact assessment) already developed by a consultant and applied in the past
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•
•
•
(not legally binding) regarding the implications on waste management of possible limit values for
the substance in Annexes IV and V: different secenarios for delimination of the concentration
range for a limit value are developed based on the application of lower and upper limitation
criteria:
-
Lower limitation criteria:
▪
Limit values must be controlable analytically,
▪
Limit values should be above existing environmental background
contaminations,
▪
the new required capacities for waste recovery and disposal are realistically
available, and
▪
required additional waste management costs are economically reasonable
-
Upper limitation criteria:
▪
Limit values should not conflict with existing limit values
▪
Avoidance of adverse effects on HH (general population plus workers) and ENV
Based on the analysis of the impacts for different options of the limit values provided by the
contractor, the Commission (DG ENV) develops an impact assessment for the options of the limit
values and decides on the preffered option. The impact assessemnt is scrutinised by the
Regulatory Scrutiny Board;
After the positive opinion of the regulatory scrutiny board, the Commission makes a proposal for
amendment of Annexes IV or V
The proposal is submitted to the ordinary legislative procedure that is followed from the
Commission side by DG ENV.
Task 2
Article 10 requires the Commission, supported by ECHA, and Member States to establish or maintain,
as appropriate, in close cooperation, appropriate programmes and mechanisms, consistent with the
state of the art, for the regular provision of comparable monitoring data on the presence of substances
as listed in Part A of Annex III in the environment. When establishing or maintaining such
programmes and mechanisms, due account shall be taken of developments under the Protocol and the
Convention. The Commission is also mandated to regularly assess the possible need for the
mandatory monitoring of a substance listed in Part B of Annex III and empowered to move a
substance form Part B of Annex III to Part A.
Annex III Part A currently contains polychlorinated dibenzo-p-dioxins and dibenzofurans
(PCDD/PCDF) and polychlorinated biphenyls (PCB). Part B currently contains hexachlorobenzene,
polycyclic aromatic hydrocarbons, pentachlorobenzene, hezachlorobutadiene and polychlorinated
naphthalenes.
Article 13(1)(e) requires Member States to draw up and publish a report containing information on
the presence of substances listed in Part A of Annex III in the environment, as compiled pursuant to
Article 10.
Article 13(2) states that where a Member State shares the information referred to in point (e) of
paragraph 1 with the Information Platform for Chemical Monitoring, this shall be indicated by that
Member State in its report and the Member State shall be considered to have fulfilled its reporting
obligations under that point. Where the information referred to in point (e) of paragraph 1 is contained
in the report of a Member State provided to ECHA, ECHA shall use the Information Platform for
Chemical Monitoring for compiling, storing and sharing that information.
Changes in the process: Yes
Task 1
•
It is expected that ECHA prepares a report with a technical assessment (hazard, risk,
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•
•
•
•
•
socioeconomic aspects) for setting concentration limit values of the substance(s) in waste and
makes a proposal for the concentration limit values.
Some detailed elements of the exising risk and socio-economic assessment methodology used so
far, especially as regards risk assessment used to determine upper limitation criteir based on
human and environmental health impacts, may need to be critically assessed and updated by
ECHA.
It is expected that ECHA’s Committee for Socio-Economic Assessment (SEAC) provides an
opinion on the report prepared by ECHA and on the concentration limit values proposed by
ECHA.
The report and the opinion of SEAC is then transmitted by ECHA to the Commission. If
significant divergence exists between the ECHA report and the SEAC opinion, ECHA submits to
the Commission an explanation of the divergence.
Based on the ECHA report and SEAC opinion, the Commission drafts a proposal for a delegated
act amending Annexes IV or V.
The procedure would be triggered on request of the Commission to ECHA; the request is expected
to come as a follow up to the Stockholm Convention amendments.
Task 2
As part of the legislative proposal on data, the operation of the Information Platform for Chemical
Monitoring is to be incorporated into the operation of the Common Data Platform on Chemicals and
hosting of the collected monitoring data shall be done by the Agencies according to their mandates.
This means that EEA will host all monitoring data in the environment.
To reflect the change of the situation with hosting the data and operation of IPCHEM, there is a need
to change the process in POPs regulation. Therefore, Member States can make the relevant data
available to the European Envrionment Agency instead of the IPCHEM and when done so, the
reproting obligatio under Article 13 (1)(e) shall be considered fulfilled. When ECHA receives such
monitoring data, it shall provide it for hosting to EEA instead of IPCHEM.
It shoud be noted that proposal for revision of water legislation requires Member States to share with
EEA all monitoring data in waters. When adopted and enforced, EEA would have practically all
monitoring data in the environment and thus the reporting under POPs would be fulfilled.
Proximity to Agencies’ mandate:
ECHA (Task 1):
Some aspects could be quite similar to that performed by ECHA under REACH
restrictions (environmental and human health risk assessment + socio-economic analysis), although
technical waste-related aspects need to be considered more (e.g. recycling targets and technical
limitations).
EEA (Task 2):
The task of hosting chemical monitoring data in the environment is a key part of the
EEA mandate and thus the new task fits very well with its mandate. The existing tools and practices
can be reused.
Projected synergies and added value of the reattribution:
Task 1 (ECHA):
Type
Reuse of
capabilities
Synergies
High
Process and expertise: ECHA already supports other work under the
POPs Regulation and performs similar work on restrictions, setting
of limit values and assessing socio-economic impacts under REACH
and other legislation. Several key capacities can be
reused/reinforced:
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−
Hazard, risk, exposure and especially also socio-economic
assessment
−
Exposure limit value definition
−
IT capabilities for stakeholder consultation and dissemination
Re-use of
data
Workload
balancing
IT tools:
automation
and
economies of
scale
Support
services:
economies of
scale
Low
Medium
Reuse of data collected under other chemical legislation, but low
availability of data on substances in products and waste streams.
In a 5-year cycle, the workload of Agency experts and Committee
experts can be balanced (although resource estimates are already
annualised).
Not an IT-intensive process, but reuse of IT capabilities for case
management, public consultation, interaction with Member States,
regulatory intentions management and data dissemination.
Low
High
Reuse of scientific support services (e.g. , prioritisation and grouping
of substances, substance identification, data management and
dissemination). Reuse of administrative services.
Type
Scientific
consistency
Robustness of
assessment and
acceptance
Independence
Added value
High
Opportunity to align priority setting, timeline, process and
methodology with other related legislation. Reuse of data collected
under other chemical legislation.
Insourcing of scientific work from consultants to Agency experts.
(See also
European Court of Auditors: External consultants at the
European Commission - Scope for reform).
High
Moving scientific work from consultants to Agency experts .
ECHA works under strict conflict of interest avoidance rules,
improving guarantees of independent scientific advice to the
Commission.
ECHA works fully transparent:
-
-
-
-
-
Overall process transparency
Publication of regulatory intentions of EU authorities
improves predictability for industry stakeholders
Public consultation/call for evidence
Stakeholder involvement/observer status
Dissemination of scientific data and outcomes
High
Transparency
High
Task 2 (EEA):
Type
Synergies
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Reuse of
capabilities
High
Process and expertise: EEA already collects and host the chemical
monitoring data in the environment. Several key capacities can be
reused/reinforced:
−
Collection and reporting tools
−
Network of Member States experts on data in the
environment
Reuse of data collected under water and air legislation
The workload can be integrated in the existing processes and can be
spread over time as necessary.
The existing reporting tools and IT capabilities used for water and air
legislation (Reportnet 3.0) can be fully reused after small adaptation.
Re-use of
data
Workload
balancing
IT tools:
automation
and
economies of
scale
Support
services:
economies of
scale
High
High
High
High
Reuse of scientific support services and data dissemination. Reuse of
administrative services.
Type
Scientific
consistency
Added value
High
Opportunity to align the formats and storing practices and thus
ensure interoperability.
Main risks and opportunities:
Task 1:
The risk assessment to be applied for the development of concentration limits is a mixture of
hazard and socio-economic analysis with a strong focus on technical waste-related aspects, for which
ECHA does not have a ready expertise. Commission and other stakeholders would benefit from
ECHA’s extensive knowledge on hazard and risk assessment as well as of socio-economic analysis;
As production shifts from primary to secondary raw materials, it would be an opportunity for ECHA
to better understand the related hazards and risks as substances/materials re-enter supply chains under
REACH jurisdictions or, when this is not possible, are disposed of in an environmentally sound
manner, as waste.
Task 2:
If and when the legislative proposal on revision of water legislation made in October 2022
will be adopted, there is an opportunity to completely abandon the reporting of monitoring data under
the POP regulation as the data will be reported under new provisions of water legislation. There is a
clear opportunity from consolidating the chemical monitoring data in the environment and humans in
EEA.
Projected impact on Agencies:
ECHA (Task 1):
•
ECHA Committees/bodies:
medium impact.
The task generates medium impact on the
setup / organisation / staffing of Committees/bodies due to the additional workload The task
requires involvement of SEAC committee
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RAC
# of
rapporteur Type of
opinions
opinion
per year
Setting waste
limit values in
Annex IV and
V
•
•
0
SEAC
# of
opinions
per year
2
rapporteur
Type of
opinion
ECHA
ECHA data model and IT infrastructure:
low impact.
The task can be implemented with
adjustments / configuration of existing data structures and IT systems
ECHA key experts:
high impact.
The task heavily relies on expert competencies, which are
limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks. New expertise
will need to be built to cover waste management.
EEA Committees/bodies:
no impact.
Committees/bodies
The task does not require involvement of EEA
EEA (Task 2):
•
•
•
EEA data model and IT infrastructure:
low impact.
The task can be implemented with
adjustments / configuration of existing data structures and IT systems
EEA key experts:
low impact.
The task relies on the expertise that already exists in the
agency.
Workload and resource implications:
Current workload and resource use:
Currently, there are 25 limit values for individual substances or groups of substances. The workload
driver is adding substances to the Stockholm Convention (new POP is also new entry here). The
experience shows that about 2 substances are added to Stockholm Convention every 2 years. Another
workload driver are review clauses that are added to substances, usually to be reviewed after 5 years.
This depends on the initiative of the Commission. Changes in exemptions may also influence the
need for an Annex IV review (due to changes in Annex A or B of the Stockholm Convention), but
not so often. For both, reviews and changes in exemptions, the workload is lower compared to
developing limit values for new substances as all the basic work has already been done.
For the latest proposal to amend Annexes IV and V of the POP Regulation, COM (2021) 656 final,
DG ENV used circa EUR 200 000 (but also relied on a preceding study of ca. EUR 100 000 covering
hazard / risk aspects) for the support study for the impact assessment with proposals for limit values
for 8 substances:
-
-
-
-
3 new and recently listed substances to the Stockholm Convention
1 substance that was under consideration by the POP Review Committee of the
Convention as a candidate (and which was added to Annex I in June 2022)
2 substances already listed in the Annex IV POP Regulation for review
2 substances already listed in the Annex IV POP Regulation for adaptation to scientific
and technical progress
20 % of the budget for this support study was dedicated to the update of information on mass flows
associated with the POP substances in question and their presence in waste (earlier reports already
identified these mass flows). 60 % of the budget for this support study was dedicated to the (i)
compilation of information in support of the IA, (ii) stakeholder consultation activities, (iii)
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comparative assessment of the impact for each concentration limit option and (iv) the proposal and
justification of the low POP concentration limits for the 8 substances. One desk officer in DG ENV
worked on this task 50% for 3 years, plus contractors 3 staff for 1 year. The final impact assessment
was written by the DG ENV staff member. DG ENV staff involvement further includes process until
adoption by the College (RSB submission, ISC, etc) and involvement in the co-decision process
(multiple interactions with the Working Party for the Environment of the Council, interaction with
MEPs and MEP assistants in the ENVI Committee and participation in trilogues).
The current resources spent by the Commission can be summarized as follows:
DG ENV
DG ENV consultants
Total
0.5 FTE per year
4.5 FTEs (EUR 300 000 for consultants) every
3 years (i.e. 1.5 FTE per year)
Ca.
2.0 FTEs annually
(to convert the cost of consultants into FTEs, the cost of 1 FTE consultant is estimated at ca. EUR
66 000 annually)
It should be noted that such Commission resources do not include contributions to the administrative
overhead of the Commission (HR, Finance, IT tools, etc.).
Current budget line: DG Environment
Future workload and resource needs:
Task 1
It is expected that the number of substances added to the Stockholm Convention will continue to be
about 2 substances every 2 years, or 1 substance per year on average. Based on current review
commitments established in review clauses in the POPs Regulation, it is expected that about 5 reviews
of existing limit values will be necessary every 5 year, i.e. on average 1 review per year.
The Commission wishes to change the procedure for amendment of Annexes IV and V from ordinary
legislative procedure to delegated act to reduce the administrative burden on the EU institutions and
to make the procedure proportional to its impact.
In order to have a scrutiny of socio-economic impacts of the chosen limit values robust and of high
quality, the Commission wishes to get an opinion of the Committee for Socio-Economic Analysis on
the proposed limit values, based on a prior ECHA report.
The process would be to some extent similar to REACH restrictions with limit values or to the setting
the Occupation Exposure Levels, with an average cost in ECHA of 1 (light dossier) – 1.5 (complex
dossier) FTE / restriction dossier, but only with the scrutiny by SEAC and not by RAC. The detailed
resource needs estimation for ECHA is as follows:
•
On average there is a need to develop 1 new dossier every year + SEAC opinion forming: 1
FTE/year, as there is no involvement of RAC (because most of the hazard assessment work
has been done already at the Stockholm Convention level and the unit cost of 1 REACH
restriction are approximately 1 (light dossier) to 1.5 (complex dossier) FTEs)
Review of existing 5 substance limit values every 5 years, or on average 1 substance every
year (at 50% effort of full new dossier) = 0.5 FTE / year
Scientific support services: substance identification and prioritisation, data management and
dissemination: additional work to be absorbed by the Agency
IT tool development cost (data submission, processing, output): contribution of 15% for
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•
•
•
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common components (0.25 FTE per year)
•
Horizontal support (governance & enablers / administrative overhead): contribution of 15%
(0.25 FTE per year)
-----------
Total: 2 FTEs per year
Task 2
The reporting of chemicals monitoring data under POPs regulation will require no or only very
minimal additional resources, as POPs monitoring data in waters are to be reported under the water
legislation and resources for that were proposed, POPs monitoring data in air are already being
reported to EEA as part of the air quality legislation and there are only very limited additional data
sets in the environment, mainly in soil which is usually collected by JRC. In addition, hosting of any
additional data sets in the environment is also covered in the resource for common data platform.
Summary of additional resource needs for the POPs regulation:
Agency
ECHA
Summary of tasks
Financial resource needs:
2024:
EUR 0
2025:
EUR 35 000
2026:
EUR 50 000
2027:
EUR 50 000
2028:
EUR 50 000
2024:
0 TAs, 0 CAs
2025:
1 TAs, 0 CAs
2026:
2 TAs, 0 CAs
2027:
2 TAs, 0 CAs
2028:
2 TAs, 0 CAs
2024:
EUR 0
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2028:
EUR 0
2024:
0 TAs, 0 CAs
2025:
0 TAs, 0 CAs
2026:
0 TAs, 0 CAs
2027:
0 TAs, 0 CAs
2028:
0 TAs, 0 CAs
Human resource needs:
EEA
Financial resource needs:
Human resource needs:
Future budget line: DG Environment
Candidate for fees: No
16. M
EDICAL DEVICES
R
EGULATION
Responsible body:
Currently: Commission with the support of the SCHEER Committee
(Re-)attribution planned to: ECHA
Legal basis for (re-)attribution:
Omnibus regulation for reattribution of tasks
Type of task:
existing
Brief task overview:
(1) Preparation and review of the guidelines on how to perform the benefit-risk
assessment of the presence of phthalates in medical devices; (2) Preparation and review of the
guidelines on how to perform the benefit-risk assessment of the presence of CMR and endocrine-
disrupting substances in medical devices. (3) Ad hoc requests for opinion on safety of a chemical in
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medical devices (not part of the proposal but possible based on general clause in ECHA founding
regulation).
Detailed process description:
Current process:
Article 5 paragraph 2 of the Regulation 2017/745 on medical devices stipulates: "A device shall meet
the general safety and performance requirements set out in Annex I which apply to it, taking into
account its intended purpose." Accordingly, Section 10.4 of Annex I, which deals with substances in
medical devices, states that "Devices shall be designed and manufactured in such a way as to reduce
as far as possible the risks posed by substances or particles, including wear debris, degradation
products and processing residues, that may be released from the device." Particular substances of
concern are those which (a) are carcinogenic, mutagenic or toxic to reproduction (CMR), of category
1A or 1B, or (b) have endocrine-disrupting properties (ED).
The Regulation further states that:
"Devices, or those parts thereof or those materials used therein that:
•
•
•
are invasive and come into direct contact with the human body,
(re)administer medicines, body liquids or other substances, including gases, to/from the
body, or
transport or store such medicines, body fluids or substances, including gases, to be
(re)administered to the body
shall only contain any such substance above the concentration of 0.1% weight by weight where
justified pursuant to Section 10.4.2. The justification shall be based on several elements, including
the latest relevant scientific committee guidelines, if applicable and available.”
Specifically for phtalates, according to Section 10.4.3, the Commission shall provide a mandate to
the relevant scientific committee to prepare such guidelines for phthalates which are subject to these
provisions. These guidelines are explicitly requested by the Regulation to be available at the latest on
the date of application of the Regulation, and are to be updated whenever appropriate on the basis of
the latest scientific evidence, or at least every five years. In its latest guidelines of 2019, the SCHEER
recommended that “Pending on new scientific evidence, it is recommended to evaluate the use and
usefulness of these Guidelines after an application period of three years.”
The Regulation also includes the option for the Commission to mandate the relevant committee to
prepare guidelines on other CMR and endocrine-disrupting substances, where appropriate.
Upon request by DG SANTE, the guidelines and opinions are produced by the relevant committee
(SCHEER). The process includes public consultation. Opinions are delivered to the Commission who
publishes them. The list of recent SCHEER opinions is https://health.ec.europa.eu/scientific-
committees/scientific-committee-health-environmental-and-emerging-risks-scheer/scheer-
opinions_en
The first guideline on how to perform the benefit-risk assessment of the presence of phthalates in
medical devices was prepared by SCHEER committee on request of the Commission in 2019. The
guideline is available here and an example of benefit/risk assessment opinion on a substance (DEHP)
is available
here.
There was no request for the preparation of the guidelines on how to perform the benefit-risk
assessment of the presence of CMR and endocrine-disrupting substances in medical device and no
such guidelines exists.
Changes in the process: Yes
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The Commission would request ECHA to prepare or review the guidelines on how to perform the
benefit-risk assessment of the presence of CMRs, endocrine disruptors and phthalates. The guideline
would be developed or reviewed by ECHA secretariat and when appropriate or when requested by
the Commission, ECHA will consult the Committee for Risk Assessment and the Committee for
Socio-Economic Analysis.
The process would follow a standardised procedure, including most likely the following steps:
-
-
-
The Commission issues the request for an opinion
Substance identification and prioritisation
Dossier preparation (by ECHA staff) with risk assessment, including
o
Hazard/risk assessment
o
Exposure assessment
o
Assessment of alternatives
Call for evidence/public consultation
Potentially RAC opinion development
Potentially SEAC opinion development
-
-
-
Proximity to ECHA mandate:
The development of the guidelines on how to perform the risk-benefit
analysis for the use of substances fits well with the mandate of ECHA, which develops various
guidelines for industry for the implementation of REACH (e.g. guidelines on risk assessment of
chemicals, guidelines on assessment of alternatives of chemicals, guideline on socio-economic
assessment).
Projected synergies and added value of reattribution:
Type
Reuse of
capabilities
Synergies
High
Process and expertise: ECHA already provides scientific advice on
chemical substances, including on phthalates, endocrine disruptors
and CMRs under REACH and other legislation. Several key
capacities can be reused/reinforced:
-
-
-
Re-use of data
High
Hazard, risk, exposure and socio-economic assessment
Committee opinion development
IT capabilities for stakeholder consultation and
dissemination (including regulatory intentions)
Reuse of data collected under other chemical legislation, especially
also on substances in products such as medical devices via the SCIP
database.
In a 5-year cycle, the workload of Agency experts and Committee
experts can be balanced (although resource estimates are already
annualised).
Not an IT-intensive process, but reuse of IT capabilities for case
management, public consultation, interaction with Member States,
regulatory intentions management and data dissemination.
Reuse of scientific support services (e.g. committee secretariat,
prioritisation and grouping of substances, substance identification,
data management and dissemination). Reuse of administrative
services.
131
Workload
balancing
Medium
IT tools:
High
automation
and economies
of scale
Support
services:
economies of
scale
High
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Type
Scientific
consistency
Added value
High
Opportunity to align priority setting, timeline, process and
methodology with other related legislation to improve coherence in
the scientific advice provided to the Commission. Reuse of data
collected under other chemical legislation.
Centralising scientific work from dispersed Commission services
and committees to one central EU Agency and its experts.
Involvement of ECHA’s scientific committees adds more scientific
robustness to the process.
Moving scientific work from dispersed Commission services and
committees to Agency experts and well-established committees in
the European Chemicals Agency with a stricter separation between
science and policy. ECHA and its committees work under stricter
conflict of interest avoidance rules, improving guarantees of
independent scientific advice to the Commission.
ECHA’s involvement will bring additional transparency to the
process:
-
-
-
-
-
Overall process transparency
Publication of regulatory intentions of EU authorities
improves predictability for industry stakeholders
Public consultation/call for evidence
Stakeholder involvement/observer status
Dissemination of scientific data and outcomes
Robustness of
assessment and
acceptance
Independence
High
High
Transparency
High
Projected impact on ECHA:
•
ECHA Committees/bodies:
low impact.
The task generates low impact on the setup /
organisation / staffing of Committees/bodies. The involvement of committees is on ad hoc
basis, maximum one opinion every 5 years
ECHA data model and IT infrastructure:
low impact.
The task can be implemented with
adjustments / configuration of existing data structures and IT systems
ECHA key experts:
medium impact.
The task relies on expert competencies, which are
limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks
•
•
Workload and resource implications:
Current workload and resource use
The SCHEER Committee has worked on six chemical-related medical device opinions in the period
2014-2022 (i.e. average of 1 opinion every 2 years):
Medical Devices
Guidelines on the benefit-risk assessment of the presence of phthalates in certain June 2019
medical devices covering phthalates which are carcinogenic, mutagenic, toxic to
reproduction (CMR) or have endocrine-disrupting (ED) properties
Opinion on the safety of medical devices containing DEHP-plasticized PVC or Feb 2016
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other plasticizers on neonates and other groups possibly at risk
Opinion on the safety of dental amalgam and alternative dental restoration
materials for patients and users
Opinion on the safety of surgical meshes used in urogynaecological surgery
Opinion on the safety of the use of bisphenol A in medical devices
Opinion on the safety of Metal-on-Metal joint replacements with a particular focus
on hip implants
Apr 2015
Dec 2015
Feb 2015
Sept 2014
The DG SANTE Secretariat covers both SCCS and SCHEER tasks and consists of 4 FTE from the
Commission staff + 2 FTE from an outsourced contract (EUR 250 000 annually) for technical and
administrative support (literature search, editing and proofreading of opinions, website mastering,
assistance for the Health-EU newsletter, dissemination activities), equally split over both committees.
The SCHEER committee itself consists of 17 external experts. The advice on chemicals in medical
devices can be roughly estimated to constitute ca. 10 % of the work of the SCHEER committee (4
out of 29 opinions during 2015-2022), which corresponds to ca. 0.3 FTE (10% of 3 FTEs from
SCHEER secretariat).
The operational costs for two committees (that includes special indemnities, accommodation, daily
allowances, travel costs, reimbursement for rapporteurship, etc) operated by the Commission were
EUR 2 883 030 for 6 years (2016-2021), which makes it approximately EUR 240 000 per year per
committee. It must be noted that the operational costs in 2019 were EUR 340 000, which then went
down because of the pandemic measures. The workload of SCHEER dedicated to support of medical
devices regulation amounts to 10% of its time, which corresponds to operational costs of EUR 24 000
(or at higher level of 2019 to EUR 34 000).
The DG SANTE medical device unit spends, according to its own accounts, 0.1 FTE annually on
following up on such scientific opinions requested from SCHEER.
The current resources spent by the Commission can be summarized as follows:
DG SANTE (policy unit)
DG SANTE (Committees unit, including
external support)
Total
0.1 FTE per year
0.3 FTE (10% of the SCHEER secretariat)
Operational costs ca. EUR 24 000/year (at peak
EUR 34 000/year)
Ca.
0.4 FTEs annually
It should be noted that such Commission resources do not include contributions to the administrative
overhead of the Commission (HR, Finance, IT tools, etc.).
Current budget line: Budget line of DG SANTE (EU4Health programme)
Future workload and resource needs:
The review of the guidelines on how to performing risk-benefit analysis of use of phthalates in
medical devices is due in 2024. It will be still reviewed by the SCHEER committee, the work has
started in April 2023. The next review will be due in 2029.
The Commission does not envisage in the near future asking for the guidelines on how to perform
risk-benefit analysis of use of CMRs and ED in medical devices.
ECHA resource needs would be as follows:
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Development of a guideline for performing risk-benefit assessment of the presence of
phthalates in certain medical devices every 5 years, including, where requested or appropriate,
scientific committee opinion forming: 0.2 FTE (~unit cost of 1 REACH restriction = 1 (light
dossier) – 1.5 (complex dossier) FTE)
•
Development of a guideline for performing risk-benefit assessment on the use of CMR and
endocrine-disrupting substances or other ad hoc mandate on chemicals in medical devices
every 5 years: 0.2 FTE (~unit cost of 1 REACH restriction = 1 – 1.5 FTE)
•
Scientific support services: substance identification and prioritisation, data management and
dissemination: contribution of 0.1 FTE based on the size of the task
•
IT tool development cost (data submission, processing, output): contribution of 15% for
common components (0.1 FTE)
•
Horizontal support (governance & enablers / administrative overhead): contribution of 15%
(0.1 FTE)
-----------
Total: 0.7 FTEs
Considering that the envisaged frequency of the work is very low, the involvement of the Committees
is only where necessary, the first work will likely materialise only in 2029, the work can be absorbed
by the agency without any additional resources.
Summary of additional resource needs for the medical devices regulation:
Agency
ECHA
Summary of tasks
- Guideline on phthalates
- Guideline on CMRs or EDs
Financial resource needs:
2024:
EUR 0
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2028:
EUR 0
2024:
0 FTE
2025:
0 FTE
2026:
0 FTE
2027:
0 FTE
2028:
0 FTE
•
Human resource needs:
Future budget line: DG SANTE
Candidate for fees: No
17. EEA
FOUNDING REGULATION
(1210/90)
Responsible body:
Currently: EEA
(Re-)attribution planned to: EEA, expanding the existing tasks
Legal basis for reattribution:
omnibus regulation on reattribution of task
Type of task:
New
Brief task overview:
1. Developing methodologies for assessment related to chemicals in the fields falling within its
mission
2. Cooperating with other agencies as regards exchange of data, defining formats and controlled
vocabularies and development of methodologies related to chemicals.
Detailed process description:
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Current process:
Task 1
EEA has some very specific tasks with some relevance to the development of methodologies
mentioned in the current founding regulation. These are:
(iv) to help ensure that environmental data at European level are comparable and, if necessary, to
encourage by appropriate means improved harmonization of methods of measurement;
(viii) to stimulate the development of methods of assessing the cost of damage to the environment
and the costs of environmental preventive, protection and restoration policies;
(xii) to support the Commission in the process of exchange of information on the development of
Environmental Assessment methodologies and best practice;
EEA however lacks the mandate and obligation to develop methodologies and for the assessment
related to chemicals. This disadvantages the EEA as compared to other agencies.
Task 2
The EEA founding regulation contains some provisions related cooperation. The Article 15 states:
1. The Agency shall actively seek the cooperation of other Community bodies and programmes, and
notably the Joint Research Centre, the Statistical Office and the Community's environmental research
and development programmes. In particular:
−
cooperation with the Joint Research Centre shall include the tasks set out in the Annex under
A,
−
coordination with the Statistical Office of the European Communities (Eurostat) and the
statistical programme of the European Communities will follow the guidelines outlined in the
Annex under B.
2. The Agency shall also cooperate actively with other bodies such as the European Space Agency,
the Organization for Economic Cooperation and Development, the Council of Europe and the
International Energy Agency as well as the United Nations and its specialized agencies, particularly
the United Nations Environment Programme (UNEP), the World Meteorological Organization and
the International Atomic Energy Authority.
2a. The Agency may cooperate in areas of common interest with those institutions in countries
which are not members of the European Communities which can provide data, information and
expertise, methodologies of data collection, analysis and assessment which are of mutual interest
and which are necessary for the successful completion of the Agency's work.
3. The cooperation referred to in paragraphs 1, 2 and 2a must in particular take account of the need
to avoid any duplication of effort.
The Annex A to the regulation lists some areas for cooperation with JRC:
A. Cooperation with the Joint Research Centre
−
−
−
−
−
Harmonization of environmental measurement methods (1).
Intercalibration of instruments (1).
Standardization of data formats.
Development of new environmental measurement methods and instruments.
Other tasks as agreed between the Executive Director of the Agency and the Director-
General of the Joint Research Centre.
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The existing provisions do not give an explicit mandate nor obligation to EEA to cooperate with
ECHA, EMA and EFSA in those areas. In order to achieve the one substance, one assessment
ambition, it is necessary to strengthen the provisions on cooperation.
Future process:
Task 1:
EEA will have a mandate to develop methodologies for the assessments related to chemicals it
performs and it will develop such methodologies based on its needs.
Task 2:
EEA actively cooperates with ECHA, EFSA and EMA as regards:
-
-
-
-
exchange of data on chemicals and defining formats and controlled vocabularies for such data
development of methodologies related to chemicals,
operation of early warning system for chemicals
operation of framework of indicators of chemical policies
The cooperation is foreseen both ways, i.e. when EEA itself makes some development in those
specified areas within its domain as well as when EFSA, ECHA and EMA make some development
in those areas within their domains. The goal is to ensure coherence, consistency and interoperability
in the specified areas.
Proximity to Agency mandate:
Both tasks fit well with the mandate of EEA as both tasks target the
areas of the EEA mandate.
Projected synergies and added value of reattribution:
Improving coherence, consistency and
interoperability among the Agencies work is the key added value.
Projected impact on EEA:
•
•
•
EEA Committees/bodies:
no impact.
The task does not involve the committee/network.
EEA data model and IT infrastructure:
low impact.
The task can be implemented with
adjustments / configuration of existing data structures and IT systems
EEA key experts:
low impact.
The task relies on expert competencies, but the task is limited
and spread over time in its nature.
Workload and resource implications:
Future workload and resource needs:
The work on the new tasks is limited and spread over time in it is nature. On a need basis, it requires
that EEA will develop methodologies for the assessment it performs as regards chemicals. The
development and setting the methodology is a standard practice for whoever performs the
assessments, so this task can be seen as a formalisation of existing EEA work. There is no need for
additional resources for this task.
EEA will also need to cooperate with ECHA, EFSA and EMA in the areas on data, formats,
methodologies, early warning system and indicator framework. The need for additional resources for
cooperation on these are already covered under the legislative proposal on data (operation of common
data platform, operation of early warning system and operation of indicator framework) and there is
no need for additional resources on this general formal mandate for agency to cooperate.
Summary of additional resource needs for EEA founding regulation:
Agency
EEA
Summary of tasks
- Development of
methodologies for
Financial resource needs:
2024:
EUR 0
2025:
EUR 0
2026:
EUR 0
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assessments related to
chemicals within its
missions
- Cooperation with ECHA,
EFSA, EMA on issues
related to chemical
Human resource needs:
2027:
EUR 0
2028:
EUR 0
2024:
0 FTE
2025:
0 FTE
2026:
0 FTE
2027:
0 FTE
2028:
0 FTE
Future budget line: DG Environment
Candidate for fees: No
18. G
ENERAL
F
OOD
L
AW
(178/2002)
Responsible body:
Currently: EFSA
(Re-)attribution planned to: EFSA, expanding and modifying the existing tasks
Legal basis for reattribution:
omnibus regulation on reattribution of task
Type of task:
New
Brief task overview:
1. Developing methodologies for assessment of chemicals in the fields falling within its mission
2. Cooperating with other agencies as regards exchange of data, defining formats and controlled
vocabularies, development of methodologies related to chemicals
3. Preventing and solving divergent opinions on chemicals with ECHA and EMA
Detailed process description:
Current process:
Task 1
EFSA has a very clear tasks in Article 23 to promote and coordinate the development of uniform risk
assessment methodologies in the fields falling within its mission. The mandate is sufficient and no
change is required.
Task 2
The EFSA founding regulation contains some provisions related to cooperation. The Article 22 that
defines the mission of EFSA states:
7. The Authority shall carry out its tasks in conditions which enable it to serve as a point of
reference by virtue of its independence, the scientific and technical quality of the opinions it
issues and the information it disseminates, the transparency of its procedures and methods of
operation, and its diligence in performing the tasks assigned to it.
It shall act in close cooperation with the competent bodies in the Member States that carry out
similar tasks to those of the Authority and, where appropriate, with the relevant Union
agencies.
The existing provisions are rather general. In order to achieve the one substance, one assessment
ambition, it is necessary to strengthen the provisions on cooperation.
Task 3
EFSA founding regulation specifies provisions for preventing and solving divergent scientific
opinions with other agencies. Article 30 states:
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1. The Authority shall exercise vigilance in order to identify at an early stage any potential source
of divergence between its scientific opinions and the scientific opinions issued by other bodies
carrying out similar tasks.
2. Where the Authority identifies a potential source of divergence, it shall contact the body in
question to ensure that all relevant scientific information is shared and in order to identify
potentially contentious scientific issues.
3. Where a substantive divergence over scientific issues has been identified and the body in
question is a Community agency or one of the Commission's Scientific Committees, the
Authority and the body concerned shall be obliged to cooperate with a view to either resolving
the divergence or presenting a joint document to the Commission clarifying the contentious
scientific issues and identifying the relevant uncertainties in the data. This document shall be
made public.
4. Where a substantive divergence over scientific issues has been identified and the body in
question is a Member State body, the Authority and the national body shall be obliged to
cooperate with a view to either resolving the divergence or preparing a joint document
clarifying the contentious scientific issues and identifying the relevant uncertainties in the
data. This document shall be made public.
The provisions need to be aligned with those for other agencies. In addition, there is a need to
strengthen the requirement to solve the divergent view by agencies among themselves, before the
matter is referred to the Commission to be solved.
Future process:
Task 1:
The existing mandate for development of methodologies is sufficient and no change is required.
Task 2:
EFSA actively cooperates with ECHA, EEA and EMA as regards:
-
-
-
-
exchange of data on chemicals and defining formats and controlled vocabularies for such data
development of methodologies related to chemicals,
operation of early warning system for chemicals
operation of framework of indicators of chemical policies
The cooperation is foreseen both ways,
i.e.
when EFSA itself makes some development in those
specified areas within its domain as well as when EEA, ECHA or EMA make some development in
those areas within their domains. The goal is to ensure coherence, consistency and interoperability in
the specified areas.
Task 3:
EFSA and body concerned shall first attempt to solve the divergent opinion on scientific or technical
issues by themselves. They shall revert the decision to the Commission only if they were not able to
solve the issue. In addition, if the divergence come from different hazard identification or
characterisation, then the Commission shall request ECHA to prepare a proposal for harmonised
classification under the CLP regulation.
Proximity to Agency mandate:
The tasks fit well with the mandate of EFSA as both tasks target the
areas of the EFSA mandate, and they are just improvement of existing tasks.
Projected synergies and added value of reattribution:
Improving coherence, consistency and
interoperability among the Agencies work is the key added value.
Projected impact on EFSA:
•
EFSA Committees/bodies:
low impact.
The task might require some ad hoc involvement of
committee/panels or their consultation.
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•
•
EFSA data model and IT infrastructure:
low impact.
The task can be implemented with
adjustments / configuration of existing data structures and IT systems
EFSA key experts:
low impact.
The task relies on expert competencies, but the task is limited
and spread over time in its nature.
Workload and resource implications:
Future workload and resource needs:
EFSA will need to cooperate with ECHA, EEA and EMA in the areas on data, formats,
methodologies, early warning system and indicator framework. The need for additional resources for
cooperation on these are already covered under the legislative proposal on data (operation of common
data platform) or they are already within the mandate of EFSA (early warning system). Consequently,
there is no need for additional resources on this general formal mandate for Authority to cooperate.
EFSA will need to try to solve any divergence in technical or scientific issue with the other agency.
EFSA already has such obligation in the existing regulation. The new task will require that the
agencies make more effort to solve the issue among themselves, instead of just forwarding the
problem to the Commission. Although it might require slightly higher amount of work by the
Authority as compared to today, such situations are rare and therefore this can be absorbed by the
Authority without any additional resources.
Summary of additional resource needs for General Food Law regulation:
Agency
EFSA
Summary of tasks
- Cooperation with ECHA, EFSA, EMA on issues
related to chemical
- Preventing and solving divergent opinions or
assessments
Financial resource
needs:
2024:
EUR 0
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2028:
EUR 0
2024:
0 FTE
2025:
0 FTE
2026:
0 FTE
2027:
0 FTE
2028:
0 FTE
Human resource
needs:
Future budget line: None
Candidate for fees: No
19. EU C
OMMON
D
ATA
P
LATFORM ON
C
HEMICALS
Responsible body:
Currently: N/A, no current process
(Re-)attribution planned to: ECHA, EFSA, EMA, EEA, EU-OSHA, JRCLegal basis for reattribution:
Proposal for a regulation of the European Parliament and of the Council establishing a common data
platform on chemicals, laying down rules to ensure that the data contained in it are findable,
accessible, interoperable and reusable and establishing a monitoring and outlook framework for
chemicals
Type of task:
new (new infrastructure but building on existing data and services)
Brief task overview:
Setting up and operation of the common data platform on chemicals.
Detailed process description:
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The principal aim of this new IT infrastructure operating as part of the Green Deal Data Space is to
support effective and coherent chemical safety assessments. It will provide integrated, user-
differentiated and highly functional access to chemicals-related datasets owned or managed by EU
agencies and IPCHEM (see section 18 below) and provide space for dedicated services supporting
EU chemicals policy and legislative implementation. Those dedicated services include the provision
of information on the obligations under EU acts on chemicals (see section 23), a repository of
reference values (see section 22), information on regulatory processes on chemicals (see section 21),
information platform for chemical monitoring (see section 20) and the database on environmental
sustainability related information on chemicals (see section 24). An integral aspect of the platform is
its governance, ensuring continuous evolution and relevance through the inclusion of further
functionalities, datasets and services (e.g. on academic studies) and ensuring support to the thriving
ecosystem of services outside the platform.
Current process:
A comprehensive assessment of the status of the chemicals data landscape was made in a feasibility
study on a common open data platform
58
. There is a large amount of chemicals data in databases,
much of it compiled following legal provisions and used in the regulatory processes but also
disseminated by EU agencies and the Commission for transparency and public use. Comprehensive
IT development has been taking place in the agencies, optimising tools applied to internal data within
the sectors, at least in specific circumstances also using common building blocks (e.g. IUCLID for
information on chemical hazards). IPCHEM (see section 20) has been developed for use across
sectors but is limited to chemical occurrence data.
Effective common access to different types of chemicals data across those solutions has however not
been made available and is therefore also not systematically applied in EU chemicals assessments,
also as any ad hoc integration is hampered by different conditions of use, differences in data formats
and applied controlled vocabularies, not least for chemical substance identification.
There is inefficiency and duplication as individual projects repeat the same efforts merging and
curating certain data across sectors for specific needs such as the validation of predictive tools. There
is also a loss of coherence or there is even divergence between assessments of the same or similar
substances or groups of substances due to differences in the datasets used.
Changes envisioned as part of setting up the common data platform
The feasibility study on a common open data platform on chemical safety data has already identified
the steps needed to establish the platform and based on the input by various stakeholders identified a
set of use cases that could be prioritised for the initial implementation of the platform, with the
functionalities and datasets to be integrated. The work in the study has been validated by the experts
responsible for the datasets considered for initial integration in the platform: a dedicated interservice
team led by ECHA, identified as the appropriate host for the platform.
The team turned it into a practical 3-year development and operations roadmap, and quantified
resources in the Project Initiation Document. It can be summarised around three main headlines:
•
design and construction of a
data container:
the technical platform solution and the data
definitions and ingestion mechanisms that enable it to receive data. While ECHA is
responsible for the IT infrastructure of the data container, cooperation (and – depending on
the data type – lead) by the other agencies in setting the data definitions and supporting the
general governance of the platform on aspects such as the determination of basic
functionalities (ingestion, use and outputs, dedicated services featuring in the platform) and
58
Feasibility study on a common open platform on chemical safety data - Publications Office of the EU (europa.eu)
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•
further evolution is essential.
The
data content
activities: data transformation, curation and confidentiality assessment.
Upload of every integrated dataset will, while based on commonly agreed rules and
vocabularies, and supported as appropriate with ingestion tools, remain the responsibility of
the data source owners (i.e. agencies), unless explicitly agreed otherwise. For data source
owners, this work will overlap with work on standard data formats and controlled vocabularies
of own datasets. Preparation of
dedicated services
available in the platform will include both
work on technical platform functionality as well as on data content. Currently, identified
services (covered separately in the sections below) include: platform on chemicals monitoring
(transfer of current IPCHEM), repository of reference values, information on obligations
under EU acts on chemicals (expansion of current EUCLEF), information on regulatory
processes (expansion of current PACT), repository of standard data formats and controlled
vocabularies and database on environmental sustainability related data.
The comprehensive roadmap of the Project Initiation Document includes a detailed list of 32
deliverables on content (in addition to 8 deliverables related to project management), planned across
the three years of development. Herein some highlight on the extent of planned minimum viable
product (MVP):
•
Improving the quality of assessments and facilitating a one substance-one assessment
approach is the principal supported
use case;
other use cases include the improvement of
quality of safety information and data, grouping and prioritisation of chemicals, enhancing
knowledge building through sharing of research outcomes (solution under development),
provision of methods and standards.
The container/content approach to the development of the
technical platform
will be
automated to the extent possible, using existing ‘building blocks’ i.e. relevant services
provided by the cloud platform. It will follow the “intentional architecture, emergent designs”
principle, leading to a container with availability of all necessary networking and development
services in the public cloud, with the necessary management tools, identity rules, enforceable
policies and security controls, and a modular and extensible character for further evolution of
e.g. analytical functionalities.
Each dataset planned for integration will be prepared for ingestion into the platform by:
o
Basic curation / profiling / metadata according to platform requirements
o
Mapping and conversion to agreed formats, use of controlled vocabularies
o
Incorporation of agreed substance identifiers, controlled vocabularies and tagging
o
Allocation of confidentiality levels / user groups (in MVP, confidential data should
be filtered before being disseminated through the platform)
o
Quality control after conversion
o
Mechanisms for (periodic) ingestion by the platform; updates, versioning
The following datasets will be included in the MVP integration:
o
ECHA REACH:
REACH registrations including Chemical Safety Reports (CSR).
This dataset already features IUCLID formatted data covering substance information,
physico-chemical properties, (eco)toxicological data, environmental fate and use
information for more than 24 000 unique substances.
o
ECHA Classification, Labelling and Packaging (CLP):
Classification and labelling
(C&L) inventory. Based on industry C&L notifications for more than 200 000
substances and EU harmonised classifications for ca. 4 600 substances. The C&L
inventory is based on a IUCLID C&L format and structured metadata.
o
ECHA Biocidal Products Regulation (BPR):
biocidal active substance approval
process data features more than 900 active substance-product type combinations. The
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•
•
•
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o
o
o
o
o
o
o
o
o
o
authorised biocidal products dataset contains over 6 000 approved products. The
process information is in a structured format but assessment reports, opinions etc. are
included as attachments. The conversion of SPCs (summary of product characteristics)
IUCLID format is underway.
ECHA Prior Informed Consent (PIC):
Substances subject to PIC the Regulation (ca
260 listed substances or substance groups).
ECHA Persistent Organic Pollutants (POP):
1) list of POPs, featuring 30
substances or substance groups; 2) list of substances proposed to be included in the
POP list of the Stockholm Convention.
EFSA OpenFoodTox:
summary of all EFSA chemical risk assessments including
chemical identifiers, critical endpoints, toxicological reference values and metadata
from EFSA outputs.
EFSA Chemical Monitoring Data:
Chemical monitoring data for pesticides and
veterinary medicinal product residues and contaminants data. The individual
measurements of chemicals in food/feed and other materials sampled as part of official
controls and enforcement activities in SSD2 format. Sampling by member states is
legally mandated under Regulation (EU) 2017/625 and associated implementing acts.
Additionally, measurements of chemicals in food and feed received from industry or
other sources in response to call for data. This data is available in IPCHEM.
EFSA OpenEFSA: All
information related to EFSA's scientific work. Tracking of the
risk assessment process from receipt of dossier to adoption of the opinion. Information
available includes status of assessments, dossiers and studies, meeting agendas and
minutes, information on experts (DOIs), public consultations).
EFSA EU_PPP Agency IUCLID:
IUCLID dossiers submitted by applicants
(industry) under Regulation (EC) No 1107/2009 concerning the placing of plant
protection products on the market. Four submission types are supported, EU PPP
Active substance, EU PPP Microorganism, EU PPP Maximum Residues Levels, EU
PPP Basic substance.
EEA Air Quality:
The EEA gathers air quality data from a wide range of sources
including current status of Europe’s air quality through five different air pollutants
(European Air Quality Index), latest measurements from Europe's air quality
monitoring network and Statistics for air pollutants calculated from officially-verified
country data for years until ‘X-2’.
EEA Waterbase Water Quality:
The dataset contains time series of concentrations
of nutrients, organic matter, hazardous substances and other chemicals in rivers, lakes,
groundwater, transitional, coastal and marine waters. This database also contains the
records reported under the Water Framework Directive Watch List for chemicals in
surface waters.
EEA Waterbase emissions:
The dataset contains time series of emissions of nutrients
and hazardous substances to water, reported by EEA member countries and
cooperating countries. It also contains data on yearly riverine input loads to
transitional, coastal and marine waters.
EEA Industrial emissions:
The data set contains data reported by Member States in
the scope of the E-PRTR Regulation and Industrial Emissions Directive. The data is
reported annually and includes releases to air/water/land and pollutant transfers of 91
pollutants and waste transfers of hazardous and non-hazardous waste (facilities in the
scope of E-PRTR); environmental permit information, application of best available
techniques (BAT) conclusions, inspections and other information on IED installations;
air emissions, operating hours and energy input from large combustion plants; and
nominal capacity from waste incinerators. This data is contained within the same
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•
database. The information is displayed in the European Industrial Emissions Portal
and the full database is published on the EEA data service in access format, with some
extracts published as Excel spreadsheets.
o
EEA National Emission reductions Commitments (NEC) Directive emission
inventory data:
Data on emissions of air pollutants (ammonia (NH3), non-methane
volatile organic compounds (NMVOC), nitrogen oxides (NOx), particulate matter 2.5
(PM2.5) and sulphur dioxide (SO2)) reported annually by Member States to the
European Commission (with copies to EEA) under Directive 2016/2284 of the
European Parliament and of the Council on the reduction of national emissions of
certain atmospheric pollutants.
o
EMA human medicinal products data
(environmental risk assessment and non-
clinical safety data)
o
EMA veterinary medicinal products
(environmental risk assessment and maximum
residue limit (MRL) values and MRL assessment data)
IPCHEM (JRC):
the existing platform for chemical occurrence data in its function and with
data will be integrated into the common data platform in two steps (see also section 18). Its
data is structured into four modules, according to the chemical monitoring data categorisation:
Environmental monitoring, Human Bio-Monitoring, Food and Feed, and Products and Indoor
Air.
Further datasets to be integrated are identified also as
dedicated services
as they include the
need for preparation and curation:
o
Regulatory processes information:
9 different ECHA processes and related
regulatory process data are currently included ECHA’s Public Activities Coordination
Tool (PACT), providing an overview of substance-specific activities. The scope of the
tool under the platform (see section 19) will include contributions by all the agencies.
o
EU Chemicals Legislation Finder (EUCLEF):
An overview of the European
Union’s legislation on chemicals. This existing service by ECHA will in future be
included under the platform (see section 23). It currently contains 51 pieces of
legislation and is integrated in ECHA’s substance database. For each piece of
legislation included in EUCLEF, a summary is provided containing the scope,
obligations, exemptions, regulatory activities and lists of impacted substances,
together with links to the full legal texts in all EU languages. The data management of
EUCLEF data is outsourced by ECHA to a service provider.
o
Repository of reference values:
reference values covered by the datasets described
above will be made available from the moment the datasets are ingested in the
platform. The outcome of the related
Health-based limit value repository (HBLVR)
study will inform when and in which format the additional datasets could be
incorporated in the platform.
o
Formats and controlled vocabularies:
agreed rules will be effectively shared on the
platform itself for integration purposes but also for use beyond the platform. This
dataset will include the work of (common) substance identification that can be then
used across any substance-specific chemical datasets.
o
.
•
•
Introducing principal data-related dimension of the current
European Observatory for
Nanomaterials (EUON)
in the common data platform has been agreed through identification
of the observatory as one of further dedicated services on the platform, allowing it also to
expand to other chemicals/materials selected to benefit from such additional compilation.
As part of the new study notification mechanism, a database of study notifications will be
established and accessible through the common data platform.
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Proximity to the mandate of the EU agencies:
While ECHA’s core mandate is focused on the safety
assessment of chemicals, it also includes the dissemination of information on chemicals and, as
expressed in its vision, being ‘the centre of knowledge on the sustainable management of chemicals’.
A better sharing of data between EU authorities can contribute to the success of ECHA’s core
mandate. There is a similar proximity in the mandates of the other agencies involved in the
development and operation of the platform through collaboration on the interoperability of their
respective data to be integrated in the platform. The use of shared data can contribute to the success
of their core mandates when tasked with assessments involving chemicals.
Projected synergies and added value of (re)attribution:
Type
Reuse of
capabilities
Synergies
High
Process and expertise: ECHA and other agencies already support
similar work on data dissemination under REACH and other
legislation. Several key capacities can be reused/reinforced:
-
-
-
Re-use of data
High
IT capabilities for data integration and public and
confidential data dissemination
IT capabilities for data submission and publication of
regulatory intentions
solutions of the chemicals legislation finder and chemical
occurrence data IPCHEM
Reuse of data collected under other chemical legislation to populate
the new platform aimed to facilitate re-use by ECHA and other
agencies (as well as other users).
With IT development work clearly defined in a 3-year project plan
and after that a running phase with much less resources, there is a
clear resource plan and little or no room for workload balancing
(and resource estimates are already annualised).
Reuse of IT capabilities for regulatory intentions management and
data dissemination building blocks. ECHA is also required to build
an EU repository of reference values and manage the chemicals
legislation finder, building on existing tools.
Reuse of scientific support services (e.g. substance identification,
data management and dissemination). Reuse of administrative
services.
Workload
balancing
Low
IT tools:
High
automation
and economies
of scale
Support
services:
economies of
scale
High
Type
Scientific
consistency
Added value
High
Opportunity to improve data sharing between EU authorities to
improve coherence in the scientific advice provided to the
Commission. Reuse of data collected under several chemical
legislations.
Centralising all data on chemicals in one central EU platform will
broaden the knowledge base and improve the robustness of the
scientific advice provided to the Commission; re-use of (same) data
144
Robustness of
assessment and
acceptance
High
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will facilitate acceptance of conclusions.
Independence
Transparency
Low
High
/
Centralising all data on chemicals in one central EU platform will
help to improve:
-
-
-
Main risks and opportunities:
-
Risks: Complex IT project with many stakeholders. Needs robust governance, clear roles and
responsibilities, resources and funding. Legal text needs to include legal basis for ECHA to
build and host and govern the platform and for other EU authorities a legal obligation to
provide data.
Opportunities: The proposal for a regulation establishing a common data platform and a
monitoring and outlook framework for chemicals should take away barriers to sharing
(confidential) data and support its re-use. Opportunities include also further benefits arising
from coordinated development of IT services between agencies and a frame that will facilitate
the evolution of existing and the development of new digital services and application of
artificial intelligence based on chemicals data (e.g. predictive tools, safe and sustainable by
design).
Committees/bodies of the agencies:
no impact.
The task does not require the involvement of
committees /bodies
Data model(s) and IT infrastructure:
high impact.
The task requires investment in entirely
new data structures and IT systems/capabilities, principally on ECHA’s side but also on the
side of data source owners preparing datasets for integration into the common data platform
Key experts:
high impact.
The task relies heavily on expert competencies; while an
important segment of preparing the IT solutions can be outsourced, work on internal data
linkages and rules supporting integration will rely on internal experts, which are limited
within the agencies and also critical to ensure continuity of ongoing regulatory tasks
Overall process transparency for EU chemicals legislation
Predictability for industry stakeholders thanks to the
publication of regulatory intentions
Dissemination of scientific data and outcomes
-
Projected impact on agencies:
•
•
•
Projected workload and resource implications:
There are extensive resources already employed in current IT/data infrastructures of the agencies, and
in the planning of the (re)attribution of tasks an IT overhead is considered to ensure the tasks are
adequately supported. It is expected that some reattribution will take place to optimally exploit
synergies with the work on the common data platform. That platform is however a new infrastructure
that in spite of longer-term benefits such as an increased effectiveness of tasks and efficiencies of
individual IT solutions (formats, vocabularies, reusable building blocks, addressing at least part of
dissemination expectation etc.) requires investment to be developed, to prepare the datasets in
adequate formats and to cover necessary overhead for operations. For dedicated services described
separately in specific sections below, only a summary of the resource estimation is given as a
repetition, in order to avoid potential double counting.
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Estimates for agencies are made on the basis of the datasets identified to be included in the MVP (see
above) and the current state of the dataset and under the assumption that ECHA develops and hosts
the common data platform.
The estimation of workload/resources required is targeting different aspects of the platform’s
lifecycle:
Work description
Development of the platform
(including
infrastructure costs until go-live)
Project management
Infrastructure setup
Governance setup and operation
Coordination of and consultation on
common data formats, rules and
ECHA,
controlled vocabularies, functionalities
and platform evolution (future planning) EFSA,
EEA,
EMA,
EU-
OSHA,
COM
incl. JRC
Note: estimate includes any infrastructure -specific work related to
the dedicated services of the common data platform.
Preparation for integration of selected
datasets (1
st
time)
Basic curation / profiling / metadata
Mapping and conversion to agreed
formats, use of agreed substance
identifiers, controlled vocabularies and
tagging, quality control
Confidentiality levels/user
groups/filtering
Mechanisms for (periodic) ingestion by
the platform; updates, versioning
For dedicated services: preparation of
datasets and functionalities
ECHA,
EFSA,
EEA,
EMA,
EU-
OSHA
Development by 2027; development duration 3 years for years
2025, 2026, 2027, annual estimates of staff expenditure, with
possible outsourcing and II costs, one-off:
ECHA: Staff 1.5 FTE (includes supervision of subcontracting);
EUR 170 000
EFSA: Staff 3.5 FTEs; EUR 350 000
Development by 2027; development duration 3 years for years
2025, 2026, 2027, annual estimates of staff expenditure, with
possible outsourcing and IT costs, one-off:
ECHA: Staff 8.5 FTE (includes supervision of subcontracting);
EUR 1 500 000
EFSA: Staff 1.5 FTEs; EUR 320 000
EEA: Staff 1.5 FTE
EMA: Staff 1.5 FTEs
EU-OSHA: Staff 0 FTEs
JRC: see IPCHEM below; existing staff, EUR 60 000 per year,
included in existing IPCHEM support
Who
Resource needs estimate
EEA: Staff 1.5 FTE; EUR 200 000
COM
incl. JRC EMA: Staff 1.5 FTE; EUR 100 000
EU-OSHA: Staff 0 FTE
JRC: see IPCHEM below; existing staff, EUR 120 000 per year,
included in existing IPCHEM support
Note: estimate includes any dataset-ingestion specific work related
to the dedicated services (preparation of all MVP identified
services attributed to ECHA).
Operation of the platform after 3-year
ECHA,
development phase, including
EFSA,
infrastructure costs after the go-live
EEA,
Recurrent costs, annual estimates of staff expenditure and costs:
ECHA: Staff 4 FTE; EUR 600 000
EFSA: Staff 2 FTE; EUR 500 000
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EMA,
EU-
OSHA
EEA: Staff 1 FTE; EUR 200 000
EMA: Staff 2 FTE; EUR 0
EU-OSHA: Staff 0 FTE
COM
incl. JRC Note: IPCHEM would be fully integrated, the majority of its data
managed by EEA, and part by ECHA.
Also includes evolution for at least 1 low and 1 medium
complexity project (see below).
In total, the development of the platform and the integration of the datasets identified in the MVP is
estimated to require 21 FTEs and ca. EUR 2 823 000 annually in the first 3 years, and recurrent
operational requirements at the level of 9 FTEs and EUR 1 300 000 annually afterwards.
Summary of additional resource needs for the common data platform on chemicals:
Agency
ECHA
Summary of tasks
Financial resource
needs:
2025:
EUR 0
2026:
EUR 2 226 000
2027:
EUR 2 793 000
2028:
EUR 600 000
2025:
4 TA, 6 CAs
2026:
4 TA, 6 CAs
2027:
4 TA, 6 CAs
2028:
4 TA, 0 CAs
2025:
EUR 0
2026:
EUR 266 000
2027:
EUR 334 000
2028:
EUR 200 000
2025:
1 TA, 2 CAs
2026:
1 TA, 2 CAs
2027:
1 TA, 2 CAs
2028:
1 TA, 0 CAs
2025:
EUR 670 000
2026:
EUR 670 000
2027:
EUR 670 000
2028:
EUR 500 000
2025:
0 TA, 5 CAs
2026:
0 TA, 5 CAs
2027:
0 TA, 5 CAs
2028:
0 TA, 2 CAs
2025:
EUR 100 000
2026:
EUR 100 000
2027:
EUR 100 000
2028:
EUR 0
2025:
0 TA, 3 CAs
2026:
0 TA, 3 CAs
2027:
0 TA, 3 CAs
2028:
0 TA, 2 CAs
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2028:
EUR 0
2025:
0 FTE
2026:
0 FTE
2027:
0 FTE
2028:
0 FTE
2025:
EUR 180 000
2026:
EUR 180 000
2027:
EUR 180 000
Human resource needs:
EEA
Financial resource
needs:
Human resource needs:
EFSA
Financial resource
needs:
Human resource needs:
EMA
Financial resource
needs:
Human resource needs:
EU - OSHA
Financial resource
needs:
Human resource needs:
JRC
Financial resource
needs:
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2028:
EUR 0
Future budget line: DG Environment, DG SANTE
Candidate for fees: No
20. I
NFORMATION
P
LATFORM FOR
C
HEMICAL
M
ONITORING
(IPCHEM)
Responsible body:
Currently: Commission (JRC), EFSA and EEA
(Re-)attribution planned to: ECHA (operation and maintenance of IPCHEM, hosting occupational
monitoring data), EEA (for collecting and hosting human biomonitoring data (HBM), hosting
environmental occurrence data and indoor air quality data), EMA (providing relevant data), EU-
OSHA (providing relevant data)
Legal basis for (re-)attribution:
Proposal for a regulation of the European Parliament and of the
Council establishing a common data platform on chemicals, laying down rules to ensure that the
data contained in it are findable, accessible, interoperable and reusable and establishing a
monitoring and outlook framework for chemicals
Type of task:
Existing
Brief task overview:
1.
Overall operation and maintenance of the Information Platform for Chemical Monitoring
(IPCHEM) and provision of data to be shared via IPCHEM.
2. Collection and hosting of human biomonitoring data
3. Hosting of environmental occurrence data
4. Hosting of indoor air monitoring data
5.
Hosting of occupational monitoring data
6.
Providing relevant data
Detailed process description:
Current process:
IPCHEM provides centralised, readily available and automated access to chemical monitoring data
held by the European Commission, European agencies, Member State Bodies, Research Centres and
Academic Institutions. It provides chemical monitoring data and information of defined quality in
terms of spatial, temporal, methodological and metrological traceability as well as a reporting tool for
chemical monitoring data (see https://ipchem.jrc.ec.europa.eu).
IPCHEM is a functioning platform hosted and operated by JRC on request of DG ENV. EEA, EFSA
and JRC are involved in the operation of the platform as module coordinators and as data providers.
Work on IPCHEM is included in the work programme of the agencies.
IPCHEM is currently structured into four thematic modules:
-
-
-
-
Module for environmental occurrence data;
Module for food and feed occurrence data;
Module for human biomonitoring data;
Module for product and indoor air data. It should be noted that for this module only the indoor
air part is developed and populated with data; templates for metadata and data are developed.
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As described in the IPCHEM governance paper, the IPCHEM governance framework involves many
actors with multiple roles, who are involved in many ways at different levels, requiring strong
interactions and collaboration.
These actors are: Policy Lead, Scientific and Technical Lead, Module coordinators, Data providers
and Partners/collaborators.
JRC currently has the scientific and technical lead of IPCHEM, with the main responsibilities of:
•
•
•
•
•
•
•
Developing and maintaining the IPCHEM platform infrastructure, functionality and
security;
Coordinating technical development and facilitating harmonisation (standardisation) of
metadata and data reporting;
Data integration and liaison with data providers;
Contribution to exploitation of IPCHEM for policy priorities;
Promoting IPCHEM by facilitating its use through technical guidance;
Supporting and guiding module coordinators;
Strategy formulation and priority setting.
The four modules are coordinated by different actors, based on the best match of the thematic area
with ongoing activities. Current coordinators are EFSA for food and feed, EEA for environment and
human biomonitoring and JRC for indoor air and products. The responsibilities of the module
coordinators focus on:
•
•
•
•
•
Identifying important data sets and data providers;
Supporting the evolution of metadata and data templates in the thematic area;
Contributing to the utilisation of IPCHEM for addressing policy questions;
Liaison with data providers;
Promoting IPCHEM as policy/regulatory support tool.
The table below describes the four categories of data included in IPCHEM, the associated data sources
and updating frequency, actors involved in the data integration process outside the IPCHEM team, to
which extent data formats are already harmonised and possible future entities to take care of these
data flows:
Source
data
of
Regular
updates
Current
players in
data
handling
through
agency
(EEA,
EFSA)
Standard formats
Frequency of related requests
to integrate such data into
IPCHEM
Future
expected
requests
Possible future
handling (EU-
CDPC
data
provider)
EU agencies
1 MS
Yes
Highly standardised
for food and feed
Standardised
some extent
environ. Data
to
for
6 datasets with annual updates
contributing most to the
number of records in IPCHEM
Increasing
number, getting
more structured
2 MS
Yes
Direct
interaction
with national
agency
Well managed data
sets but all in
different formats
7 datasets with regular updates,
contributing substantially to the
number of records in IPCHEM
+ indoor air data and
occupational monitoring data*
from MS in the pipeline
moving more
towards
category 1 with
these data
EU agencies
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3 EU funded
research
projects
No
Individual
projects or
Cluster level
data WG
Less standardised,
all different; but
reaching
more
harmonisation
in
Clusters recently
10 EU projects already
included + 4 new large EU
projects or Clusters in the
pipeline
Remaining at
similar
level,
e.g. an average
2-3
research
clusters
supported
in
parallel
Decreasing
trend,
less
relevant for the
future
**
4 National or
regional
research
projects
No or very
low
frequency
Direct
interaction
with research
organisation
Less standardised,
all different
~6 datasets
(encouraged in the beginning to
populate IPCHEM, now not
promoted any more)
**
Changes in the process:
ECHA shall operate and maintain IPCHEM as part of the common data platform on chemicals. In
addition, ECHA will be required to host and maintain occurrence data related to workplace
monitoring.
EEA will be responsible for collecting and hosting the human biomonitoring data and for hosting
environmental monitoring data and indoor air data currently collected or hosted by JRC as part of
IPCHEM.
IPCHEM will be integrated in the common data platform with its functionalities and data representing
part of Minimum Viable Product.
The required tasks are divided according to the container-content concept. The container considers
the IPCHEM platform with its data management structure and user interface, while the content refers
to the monitoring data contained in the four IPCHEM modules, based on data already included and
on anticipated future data needs.
Regarding the content, the four categories of data included in IPCHEM, the associated data sources
and updating frequency, actors involved in the data integration process outside the IPCHEM team, to
which extent data formats are already harmonised and possible future entities to take care of these
data flows are shown in the table above.
Regarding the container, the term refers to the IPCHEM platform with its architecture, data
management structures and user interface.
In the process of integration into the common data platform on chemicals, the data management
structure is considered separately from the user interface.
1.
User interface:
The current user interface of IPCHEM was built over many years, is difficult to
maintain and also not entirely fit for purpose to address all relevant envisaged uses and search
types of IPCHEM.
It is therefore proposed to re-build the user interface in the context of the integration into the
common data platform. The prototype user interface developed by the JRC IPCHEM team in June
2022 should be considered as a starting point and to help estimate the resources needed. The new
user interface implementation is expected to be driven by the IPCHEM and the common data
platform’s use cases involving monitoring (occurrence) data.
2.
Data management structure:
IPCHEM has a generalised structure, that aims to accommodate
the monitoring data regarding different media and coming from several data providers. The
current harmonisation process encompasses all the transformation steps required from the source
data structure to the IPCHEM harmonized one. Two different record layouts are enforced, one for
the individual measurement type of datasets and the other for the statistical type of datasets; in
both cases, only a common subset of the data is harmonised, and quality checked, while the
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remaining information provided are encapsulated as-is into a generic field called source data,
using the JavaScript Object Notation (JSON) format as a convenient yet flexible vehicle.
IPCHEM has two sub-systems: IPCHEM Portal is the subsystem providing access to the
harmonised and integrated data, while IPCHEM Share is the subsystem providing the file-sharing
feature, compliant with the requirements defined by JRC Local Informatics Security Officer for
the secure hosting of sensitive non classified data (e.g. two-factor authentication, encryption at
rest, token secured application programming interface (API), etc.).
It is advised to preserve this current structure of the system, in the transfer to the common data
platform. The IPCHEM team is preparing detailed documentation and can support the hand-over.
A 2-step approach is proposed as the most efficient way of integrating IPCHEM into the common
data platform:
1
st
phase (months 1-12): making monitoring data from IPCHEM findable via the common data
platform, and preparatory work for functionality handover (co-work JRC/ECHA)
Aims:
-
-
-
IPCHEM extended team contributes to the work on data, in particular the selection of substance
identifiers and the selection of the supported format for inclusion of monitoring (occurrence) data.
IPCHEM data contribution to the common data platform is analysed (data governance and policy)
in accordance with the legislative proposal on data
IPCHEM extended team carries out a study to make metadata and data available in IPCHEM
more FAIR, including harmonisation of module specific metadata and data fields with the
common data platform requirements (point above), including in the preparation for the anticipated
future data providers to the platform for individual datasets
Linking IPCHEM to the common data platform via metadata and substance identifiers; substance
search will bring back links to IPCHEM datasets with the metadata description in agreed format
22
Analysis (container/functionality handover), identification of use cases, implementation planning
-
-
Tasks
1.
IPCHEM/EU-CDPC linking:
a. Analysis and design for the integration of:
i. Substance identity
ii. Harmonised metadata (common to all modules)
b. Implementation
i. Preparation of SID translation tables, metadata for IPCHEM datasets
ii. accessibility of harmonised metadata, as designed in [a.ii.](automated approach)
c. Testing
d. Maintenance/Servicing
2.
Handover preparation IPCHEM/common data platform
a. Analysis and design:
i. Evaluation of the IPCHEM data governance within the common data platform
(to/with platform data providers, existing IPCHEM datasets and future updates,
possible use of DIGIT’s hosting facilities)
ii. FAIR evolution of the IPCHEM platform for better data harmonization and
reuse:
1. Definition of harmonised formats including module specific metadata and
data fields for monitoring (occurrence) data, part of joint WA3 initiative
2. Solution design for managing harmonised module specific metadata and
data fields
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iii. Strategy definition for IPCHEM functionalities handover to the common data
platform, including the secure sharing facilities (aka IPCHEM Share), the dataset
integration software procedures, and identifying the user interface capabilities
that are required by the platform's use cases involving monitoring (occurrence)
data (possible use of DIGIT’s hosting facilities)
b. Governance aspects, data management
Resource needs 1
st
phase
•
Platform development (60K)
o
1 developer full time for 8 months for complementing in IPCHEM the information
and formatting required for the linking with the common data platform, in addition to
what is already available in the public repository
(https://ipchem.jrc.ec.europa.eu/public), or in the IPCHEM share subsystem
(https://ipchem.jrc.ec.europa.eu/share via secure API); this encompasses possible
enhancements (e.g. JSON-LD / RDF metadata format, DCAT-AP service, etc.) to
make the system more FAIR;
Handover preparation (120K)
o
1 analyst, expert in chemicals monitoring in charge of supporting substance
identification and metadata and data harmonisation (in close collaboration with
module coordinators) for 12 months
o
1 regulatory expert to prepare the adoption of more harmonised formats and perform
impact assessment (on the common data platform, data providers and modules
coordinators) for 12 months
•
2
nd
phase (months 12-36): IPCHEM full integration into the common data platform
Aims:
-
-
-
-
Single interface to IPCHEM data through common data platform
IPCHEM functionalities are gradually handed over to the platform
A new governance is put in place incorporating harmonisation and regulatory updates
Data flow is established between the data providers (agencies) and the platform
Tasks
1.
Supporting the common data platform occurrence data governance implementation and
IPCHEM functionalities transfer to the platform
a. Data Management
i. Defining a new data governance
ii. Defining a new data policy
iii. Planning IPCHEM data management handover
b. Implementation
i. Supporting the implementation of IPCHEM functionalities in the platform,
including the rebuilding of the user interface with up-to-date technologies, to best
address the platform's uses cases involving the monitoring (occurrence) data;
ii. Implementing IPCHEM data management handover
c. Testing
d. Maintenance/Servicing
i. Provisioning of support to data providers for transitioning to platform data
submission
2.
Implementing more rich and FAIR metadata and data formats
a. Supporting ECHA in the design
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3.
Implementing business analytics features, starting from the platform’s use cases involving the
monitoring data
a. Supporting ECHA in the design
Resource needs 2
nd
phase
•
Platform development (100K)
o
1 developer full time for 18 months for fully integrating IPCHEM metadata and data
into the common data platform
Dataset preparation (220K)
o
1 data analyst, expert in chemicals monitoring, in charge of enhancing the IPCHEM
metadata and data formats (i.e. to make metadata and data more rich and FAIR), for
24 months
o
1 regulatory expert to prepare full transfer of the data management process (data
policy, governance, data flows, etc.), for 18 months
While ECHA’s core mandate is focused on the safety assessment of chemicals, ECHA’s
mandate includes the dissemination of information on chemicals. A better sharing of data
between EU authorities can contribute to the success of ECHA’s core mandate. As ECHA is
tasked to operate the common data platform on chemicals, the operation of IPCHEM and its
integration into that platform fit well with ECHA existing tasks.
EEA already acts as a module coordinator for human biomonitoring and thus hosting of
human biomonitoring data would fit with the existing mandate of EEA. Hosting human
biomonitoring data, environmental monitoring data and indoor air quality data fits well into
EEA work on human health and the environment, as the data provides a good basis for the
assessment of environmental impacts on human health.
ECHA is currently performing scientific assessments underpinning the setting of occupational
exposure limit values so hosting occupational monitoring data fits well with its mandate.
•
Proximity to agencies’ mandate:
-
-
-
Projected synergies and added value of (re-)attribution:
Type
Reuse of
capabilities
Synergies
High
Process and expertise:
ECHA already supports similar work on data dissemination under
REACH and other legislation. ECHA is also tasked to develop and
operate the common data platform on chemicals. Several key
capacities can be reused/reinforced:
IT capabilities for data integration and public and
confidential data dissemination
-
IT capabilities for data submission and publication of
regulatory intentions
-
Development and operation of the common data platform on
chemicals
EEA already hosts environmental occurrence data and has a deep
expertise in collecting and hosting the data.
Re-use of data
Workload
balancing
N/A
Low
N/A
With the IT development work clearly defined in a 3-year project
plan and after that a running phase with much less resources, there
is a clear resource plan and little or no room for workload balancing
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(and resource estimates are already annualised).
IT tools:
High
automation
and economies
of scale
Support
services:
economies of
scale
High
Reuse of IT, reporting and hosting capabilities.
Reuse of scientific support services and of administrative services.
Projected impact on agencies
•
•
•
Committees/bodies:
low impact.
The task does not require involvement of agencies’
committees /bodies. EEA might use their networks for collecting human biomonitoring data
Data model and IT infrastructure:
high impact.
The task requires investment in data structures
and IT systems/capabilities
Key experts:
high impact.
The task heavily relies on expert competencies, but these are
present in the agencies.
Workload and resource implications:
Current workload and resource use:
JRC has a total of 4.5 FTE (2.5 JRC staff, 2 external consultants intramuros) assigned to the IPCHEM
operation. There are also resources allocated to the contribution to IPCHEM in the work programmes
of EFSA and EEA.
The current resources spent by the Commission can be summarized as follows:
DG JRC
Yearly IT maintenance costs from JRC
corporate hosting facility
Total
4.5 FTE per year (2.5 JRC staff and 2 external
consultants intramuros)
EUR 11 700 per year
4.5 FTEs annually
Current budget line: DG JRC institutional work programme
Future workload and resource use:
The integration of IPCHEM into the common data platform, the continuous provision of data by the
agencies to the IPCHEM and coordination/cooperation among the agencies is included in the resource
estimates under the common data platform on chemicals. The integration will be done jointly by JRC
and ECHA. ECHA will take over the operation of IPCHEM from JRC and will take over hosting of
occupational monitoring data. For this ECHA will need 2 FTEs. In addition, EEA will take over from
JRC collection and hosting of human biomonitoring data and hosting of IPCHEM environmental
occurrence data and indoor air monitoring data. For this, EEA will need 1 FTE per year. EFSA
already provides data to IPCHEM and contributes to its operation and will not require any additional
resources to continue in this activity. EMA and EU-OSHA currently do not systematically collect or
receive data relevant for IPCHEM and therefore will not require any additional resources.
Summary of resource needs for maintaining IPCHEM and its parts after its integration into the
common data platform on chemicals:
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Agency
ECHA
Summary of tasks
Operation and development of IPCHEM
Collecting and hosting occupational monitoring
data
Financial resource
needs:
2025:
EUR 0
2026:
EUR 0
2027:
EUR 180 000
2028:
EUR 180 000
2025:
0 TA, 0 CAs
2026:
1 TA, 1 CAs
2027:
1 TA, 1 CAs
2028:
1 TA, 1 CAs
2025:
EUR 0
2026:
EUR 200 000
2027:
EUR 200 000
2028:
EUR 50 000
2025:
1 TA, 0 CAs
2026:
1 TA, 0 CAs
2027:
1 TA, 0 CAs
2028:
1 TA, 0 CAs
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2028:
EUR 0
2025:
0 FTEs
2026:
0 FTEs
2027:
0 FTEs
2028:
0 FTEs
Human resource
needs:
EEA
Collecting and hosting human biomonitoring data,
developing a data model and creating a reporting
structure to host human biomonitoring data.
Hosting indoor air data
Collecting and hosting environmental occurrence
data
Financial resource
needs:
Human resource
needs:
EFSA
EMA
EU-
OSHA
Provision of occurrence data
Cooperation and coordination on IPCHEM
Financial resource
needs:
Human resource
needs:
Future budget line: DG Environment
Candidate for fees: No
21. I
NFORMATION ON REGULATORY PROCESSES ON CHEMICALS
Responsible body:
Currently: ECHA (existing (P)ACT), EFSA (existing OpenEFSA)
(Re-)attribution planned to: ECHA, EFSA EEA and, EU-OSHA
Legal basis for (re-)attribution:
Proposal for a regulation of the European Parliament and of the
Council establishing a common data platform on chemicals, laying down rules to ensure that the data
contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and
outlook framework for chemicals
Type of task:
Existing but expanded to cover all chemical sectors
Brief task overview:
(1) Operating (public) activities coordination tool; (2) notifying relevant
information to the (public) activities coordination tool
Detailed process description:
Current process:
The Activities Coordination Tool and its public counterpart, (P)ACT, are two existing information
systems developed and operated by ECHA which provide an up-to-date overview of all planned and
ongoing initiatives on chemicals by authorities under REACH and CLP. The information is provided
in user-friendly tables and is regularly updated. The information is provided by authorities and
includes information on authorities' actions (intention/on-going/finalisation) relevant for an
assessment process.
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ACT helps authorities to coordinate their work by providing information on planned, ongoing or
completed substance-specific activities. PACT (public ACT) ensures transparency of regulatory
safety assessment work. It gives the public an ‘early warning’ of the substances that are on an
authority’s radar for exploring the need for regulatory risk management and provides a more holistic
picture of what is going on under different regulatory processes. The processes and legislation already
covered by (P)ACT are indicated in the table below.
Through a recent project, ECHA reviewed the tool to improve its efficiency and functionality and to
allow extension to further processes under its remit.
EFSA, as part of their existing activities, also provide some level of digital transparency on their
planned, ongoing and concluded assessments, as part of their general OpenEFSA portal. The portal
provides access to information related to EFSA's scientific work, tracking of the risk assessment
process from receipt of a dossier to adoption of the opinion. Information available includes: status of
assessments, dossiers and studies, meeting agendas and minutes, information on experts (DOIs) and
public consultations. The OpenEFSA portal is similar to PACT. The OpenEFSA portal does not have
a confidential ‘ACT’ part. The processes and legislation already covered by OpenEFSA are indicated
in the table below.
Metadata and formats behind both IT tools are not easily comparable, but a lot of work has already
been put in the organisation of this information and in building processes to keep updating the
systems.
Changes in the process:
To promote the coordination of safety assessment activities across EU legislation, the ‘one substance,
one assessment’ approach considers progressively expanding the existing (P)ACT from including
REACH and CLP regulations to including all relevant chemicals legislation with safety assessment
processes and initiatives.
ECHA will operate an extended (P)ACT service, starting with a similar functionality of the existing
tool but addressing processes across all the sectors where chemical assessments are performed. ECHA
will provide relevant information into (P)ACT for all the processes from legislation for which ECHA
is or will be an assessment body. EFSA will provide to ECHA for integration into (P)ACT the relevant
information for all the processes from legislation for which EFSA is an assessment body and that are
already covered in the OpenEFSA portal. In other words, EFSA is toensure that OpenEFSA
information feeds into the (P)ACT and is further complemented for confidential part on intentions,
where relevant. Finally, EEA and EU-OSHA will provide to ECHA for integration into PACT any
relevant information for the process from legislation for which EU-OSHA is an assessment body.
The processes and legislation to be included in the extended (P)ACT are identified in the table below.
The extended (P)ACT will be available as a specific service under the common data platform
(dedicated service on ‘information on regulatory processes on chemicals’), with the identification of
individual processes as well as associated datasets (starting with substance identification) covered by
the controlled vocabularies. The service will maintain the differentiated authorities/public access,
with up-to-date public information on declared registries of intent, status of assessment in progress
and outcomes (including documentation) once concluded. Authorities will have access to further
categories and datasets for informing on preliminary intent supporting exchange and coordination as
appropriate, and where relevant access to working material during the process. The governance will
be done through the governance of the common data platform on chemicals.
To control complexity, a solution as regards the update of the information in the platform,
maintenance of relevant lists, metadata and supporting datasets will need to be prepared by the
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agencies involved as principal actors in particular processes, even for cases where further actors may
be involved or even ultimately responsible for the process outcome (e.g. national authorities).
Overview of legislation and processes included or to be included in (P)ACT (referred to as
‘information on regulatory processes on chemicals’ as the dedicated service in the common data
platform on chemicals):
Legislation
Processes already
covered or to be
included in ACT
(ACT covers also
intentions)
Legislation already covered in (P)ACT
Regulation (EC) 1907/2006 concerning the
Registration,
Evaluation,
Authorisation
and
Restriction of Chemicals (REACH), establishing a
European Chemicals Agency
- Screening
- Dossier evaluation
- Substance evaluation
- ED, PBT
identification
- RMOA
- SVHC identification
- Annex XIV
- Application for
authorisation
- Restriction
- CLH
-
- Dossier evaluation
- Substance evaluation
- ED, PBT identification
- RMOA
- SVHC identification
-
-
- Restriction
- CLH
Processes already covered
or to be included in PACT
(PACT covers the ongoing
processes)
Regulation (EC) 1272/2008 on classification, labelling
and packaging of chemicals of substances and
mixtures
Regulation (EU) 2019/1021 on persistent organic
pollutants
-
- Proposal for listing
- Limit values (UTC, low
POP content)
Legislation for which discussions for inclusion in (P)ACT are ongoing
Regulation (EU) No 528/2012 concerning the making
available on the market and use of biocidal products
Discussions are ongoing:
- Evaluation of active substance
- Opinion of BPC on active substance approval
Legislation identified to be included in (P)ACT and for which ECHA is or will be an assessment body
Directive 2004/37/EC on the protection of workers
from the risks related to exposure to carcinogens or
mutagens at work
Directive 98/24/EC on the protection of workers from
the risks related to chemical agents at work
Directive 2009/148/EC on the protection of workers
from the risks related to exposure to asbestos
Stockholm
pollutants
Convention
on
persistent
organic
- Setting EU OELs;
- Setting national OELs
- Setting EU OELs
- Setting national OELs
- Setting new EU OELs
- Intention to nominate a substance as POP
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Directive 2011/65/EU on the restriction of the use of
certain hazardous substances in electrical and
electronic equipment
Directive 2000/53/EC on end-of life vehicles
Proposal for a Regulation concerning batteries and
waste batteries
Directive 2008/105/EC on environmental quality
standards in the field of water policy
Directive 2006/118/EC on the protection
groundwater against pollution and deterioration
of
- Review of exemptions
- Review of exemptions
- Restriction process
- EQS derivation EU and national
- addition/removal of substance to watch list
- Limit value derivation EU and national?
- Addition/removal of substance to watch list
- Safety assessment of contact materials
- Safety assessment;
- Safety assessment;
Directive (EU) 2020/2184 on the quality of water
intended for human consumption
Regulation (EC) No 1223/2009 on cosmetic products
Directive 2009/48/EC on the safety of toys
Legislation identified to be included in (P)ACT and for which EFSA is an assessment body and information is
included in OpenEFSA
Regulation (EC) No 178/2002 laying down the general
principles and requirements of food law, establishing
the European Food Safety Authority and laying down
procedures in matters of food safety
Regulation (EC) No 1935/2004 on materials and
articles intended to come into contact with food
Commission Regulation (EU) No 10/2011 on
plastic materials and articles intended to come
into contact with food
-
Commission Regulation (EC) No 450/2009 on
active and intelligent materials and articles
intended to come into contact with food
-
Commission Regulation (EC) No 282/2008 on
recycled plastic materials and articles intended
to come into contact with foods
-
Commission Directive 2007/42/EC relating to
materials and articles made of regenerated
cellulose film intended to come into contact
with foodstuffs
-
Commission Regulation (EU) 2018/213 on the
use of bisphenol A in varnishes and coatings
intended to come into contact with food
-
Commission Regulation (EC) No 1895/2005
on the restriction of use of certain epoxy
derivatives in materials and articles intended to
come into contact with food
Council Directive 84/500/EEC on the approximation of
the laws of the Member States relating to ceramic articles
intended to come into contact with foodstuffs
Commission Directive 93/11/EEC concerning the release
of the N-nitrosamines and N- nitrosatable substances
from elastomer or rubber teats and soothers
-
- To be included (relevant processes to be identified)
- Safety assessment
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Regulation (EC) No 1331/2008 establishing a common
authorisation procedure for food additives, food
enzymes and food flavourings
Regulation (EC) No 1333/2008 on food additives
Regulation (EC) No 1332/2008 on food enzymes
Regulation (EC) No 1334/2008 on flavourings and
certain food ingredients with flavouring properties
for use in and on foods
Commission Regulation (EU) No 234/2011
implementing Regulation (EC) No 1331/2008
establishing a common authorisation procedure
for food additives, food enzymes and food
flavourings
Directive 2009/32/EC on the approximation of the
laws of the Member States on extraction solvents used
in the production of foodstuffs and food ingredients
Council Regulation (EEC) No 315/93 laying down
Community procedures for contaminants in food
Commission Regulation (EC) No 1881/2006
setting maximum levels for certain
contaminants in foodstuffs
-
Commission Implementing Regulation (EU)
No 884/2014 imposing special conditions
governing the import of certain feed and food
from certain third countries due to
contamination risk by aflatoxins
-
Commission Regulation (EC) No 401/2006
laying down the methods of sampling and
analysis for the official control of the levels of
mycotoxins in foodstuffs
-
Commission Regulation (EC) No 333/2007
laying down the methods of sampling and
analysis for the official control of the levels of
lead, cadmium, mercury, inorganic tin, 3-
MCPD and benzo(a)pyrene in foodstuffs
-
Commission Regulation (EU) 2017/644 laying
down methods of sampling and analysis for the
control of levels of dioxins, dioxin-like PCBs
and non-dioxin-like PCBs in certain foodstuffs
-
Commission Regulation (EC) No 1882/2006
laying down methods of sampling and analysis
for the official control of the levels of nitrates
in certain foodstuffs
Directive 2002/32/EC on undesirable substances in
animal feed
Regulation (EC) No 1107/2009 concerning the placing
of plant protection products on the market
Regulation (EC) No 396/2005 on maximum residue
levels of pesticides in or on food and feed of plant and
animal origin
Regulation (EC) No 1831/2003 on additives for use in
animal nutrition
-
-
- Safety assessment
- Safety assessment
- Safety assessment
- Safety assessment
- Safety assessment as part of the substance (re-)approval
process
- Safety assessment as part of the reviewing, amending,
setting, deleting of MRLs
- Safety assessment
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-
Commission Regulation (EC) No 429/2008 on
detailed rules for the implementation of
Regulation (EC) No 1831/2003 as regards the
preparation and the presentation of applications
and the assessment and the authorisation of
feed additives
Proximity to the mandate of agencies:
for ECHA
very high,
as it developed and operated the tool,
and is designated as the manager of the common data platform in the future. For EFSA
very high,
as
EFSA already operates the OpenEFSA portal.
Projected synergies and added value of reattribution:
Synergies come from the fact that one system or dedicated service can serve multiple agencies. The
added value of the system is that all agencies and stakeholders will be able to find out at one place
about the ongoing or planned regulatory processes on substances. The development of the dedicated
service on information on regulatory processes on chemicals (I.e. extended PACT) will be done as
part of the development of the common data platform on chemicals, exploiting the same governance
process and building blocks required.
Main risks and opportunities:
The development of an all-encompassing controlled vocabulary and rules for all the different
contributors will be extensive. It is however not considered a risk as all processes are individually
well controlled by the agencies responsible for the implementation of the individual pieces of
legislation. Risks are mitigated by the designated role of the agencies. The dedicated service on
information on regulatory processes on chemicals provides a major opportunity to facilitate the
coordination between the assessments and reuse of assessments performed elsewhere, to avoid
duplication of work and to save time when informed decisions on further management actions can be
taken.
Projected impact on agencies
•
Committees/bodies:
no impact.
The task does not require the involvement of committees
/bodies (with the exemption of their secretariat that will be the main provider of respective
information from the committees to the dedicated service on information on regulatory
processes, as is the case now for PACT)
Agencies’ data model and IT infrastructure:
high impact.
The same considerations apply as
for the development of the common data platform in its entirety. The data models of 4 agencies
for this type of information will have to be aligned.
Agencies’ key experts:
no impact.
The task does not require a specific expertise. The task is
effectively just a reporting/documenting of the processes.
•
•
Projected workload and resource implications:
Future workload and resource needs:
Work description
Developing the dedicated service on
information on regulatory processes
on chemicals as part of the common
data platform
Designing and developing the dedicated ECHA
service’s data structure, functionalities
and IT service.
See common data platform estimates: preparation of the
dedicated service on information on regulatory processes on
Who
Resource needs estimate
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Notably most of the building blocks of
existing ECHA (P)ACT can be reused.
Experiences from similar portals like
OpenEFSA from other agencies need to
be included. Proper consideration must
be given to the service’s functioning
through differentiated access
(agencies/public) and the ability to
efficiently (albeit within constraints)
serve during transitional periods while
legal provisions on sharing between
agencies are still being adopted.
Cooperation with and providing input to
ECHA for the development of the
dedicated service on information on
regulatory processes on chemicals (as
part of the common data platform
governance)
EFSA,
EEA,
EU-OSHA,
COM
chemicals is already included in the estimate as part of MVP
basic IT infrastructure.
The dedicated service is expected to be included already in the
first demo at T0+12 months, likely with limited coverage of
processes included (ECHA, EFSA). Full functionality is expected
in the goLive version in 2028.
Contribution expected by EFSA, EEA, EU-OSHA and COM to
help identify structure and functionalities, also on the basis of
own experiences and expected needs. Ideally covered by the
agencies’ core staff but can include external IT expertise in
particular when one was covering existing solutions. Resources
should be absorbed by the agencies as part of the resources
assigned to the development of the common data platform.
ECHA will have to integrate the remaining data flows for
legislation not yet included in the current PACT. This is covered
by the resources allocated as part of the proposals which
reattributes certain processes to ECHA and which should be
included in PACT.
EFSA already have the data flows developed. They might need to
be amended and retargeted to feed into the dedicated service on
information on regulatory processes on chemicals.
EEA, EU-OSHA will need to develop data flows and integrate
them into the dedicated service.
Resource needs are covered in the estimation for the operation of
the common data platform
Based on common agreements,
preparation of internal dataflows,
packaging of regulatory processes
information and supporting ingestion
into the common data platform
ECHA,
EFSA,
EEA,
EU-OSHA
COM
Provision of regulatory information
Keeping the dedicated service on
information on regulatory processes on
chemicals up-to-date by recurrent
ingestion of new information and
revision of existing one.
The processes may include other actors
than the agencies (e.g. competent
authorities), however agencies would be
responsible for packaging the
information and linking with ECHA’s
platform, in a consistent manner.
Providing ‘legacy regulatory
ECHA,
information’ (i.e. information already
EFSA,
available before entry into force of the EMA
regulation establishing the common data
platform)
ECHA,
EFSA,
EEA,
EU-OSHA
While it is anticipated that the internal dataflows will reflect
agreements on common metadata on processes, resulting in little
overhead in order to ‘package’ for the platform, some additional
resources will be required. The extent depends on the number of
processes initiated (and should therefore be covered within
proportionate IT overhead in case additional tasks are attributed
to an agency), and to a degree the level of detail regarding
information on intermediate steps and data to be associated.
A general estimate of basic information is considered in the
estimate for common data platform operations – no further
resources are included here.
It is considered that information already provided in some
structure on respective IT platforms will be able to be introduced
into the dedicated service on information on regulatory processes
on chemicals. This would be achieved in a progressive way (with
prioritization) but should be achieved with resources covered by
the common data platform operation.
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Overview of resource needs per agency for the operation of the dedicated service on information on
regulatory processes on chemicals:
Agency
ECHA
Summary of tasks
Designing and developing the dedicated service’ data
structure, functionalities and IT service.
Operating the dedicated service as part of the common
data platform on chemicals
Based on common agreements, preparation of internal
dataflows, packaging of regulatory processes
information and supporting ingestion into the
common data platform
Keeping the dedicated service up-to-date by recurrent
ingestion of new information and revision of existing
one.
Providing ‘legacy regulatory information’
EEA
EU-OSHA
Cooperation with and providing input to ECHA for
the development of the dedicated service
Based on common agreements, preparation of internal
dataflows, packaging of regulatory processes
information and supporting ingestion into the
common data platform
Keeping the dedicated service up-to-date by recurrent
ingestion of new information and revision of existing
one.
EFSA
Providing ‘legacy regulatory information’
Cooperation with and providing input to ECHA for
the development of the dedicated service
Based on common agreements, preparation of internal
dataflows, packaging of regulatory processes
information and supporting ingestion into the
common data platform
Keeping the dedicated service up-to-date by recurrent
ingestion of new information and revision of existing
one.
Providing ‘legacy regulatory information’
Financial
resource
needs:
EEA and EU-OSHA are
currently not involved in any
processes relevant for the
database, therefore no
resources are required for
them.
Included as part of the
common data platform on
chemicals + to be absorbed as
part of the individual
regulatory processes
Included as part of the
common data platform on
chemicals + to be absorbed as
part of the individual
regulatory processes
Included as part of the
common data platform on
chemicals + to be absorbed as
part of the individual
regulatory processes
Financial
resource
needs:
Included as part of the
common data platform on
chemicals + to be absorbed as
part of the individual
regulatory processes
Included as part of the
common data platform on
chemicals + to be absorbed as
part of the individual
regulatory processes
Human
resource
needs:
Human
resource
needs:
Financial
resource
needs:
Human
resource
needs:
Future budget line: As part of the agencies’ budgets
Candidate for fees: No
22. R
EPOSITORY OF REFERENCE VALUES
Responsible body:
Currently: ECHA (some reference values as part of EUCLEF), EFSA (some reference values as part
of open food tox database), Commission – DG SANTE (some reference values as part of the
pesticides database)
(Re-)attribution planned to: ECHA, EFSA, EMA, EU-OSHA [and Commission – DG SANTE]
Legal basis for (re-)attribution:
Proposal for a regulation of the European Parliament and of the
Council establishing a common data platform on chemicals, laying down rules to ensure that the data
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contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and
outlook framework for chemicals
Type of task:
Existing but extending the scope and centralizing the reference values in one
repository
Brief task overview:
Setting up and operating a centralized repository of reference values derived or
collected as part of the implementation of Union chemicals legislation or on the request of the
Commission also those provided by the Member States or international organization.
Detailed process description:
Current process:
EFSA has developed and is maintaining the OpenFoodTox database
1
. It is a structured database (Exel
sheet) summarising the outcomes of all hazard identification and characterisation for human health
(plant protection products, food improvement agents, and contaminants), animal health (feed
additives, pesticides and contaminants) and the environment (feed additives and pesticides)
performed by EFSA. OpenFoodTox provides information on substance identity and characterisation,
links to EFSA’s related output, relevant background EU legislation, and a summary of the critical
toxicological endpoints and reference values for the substance. The data model of OpenFoodTox has
been designed using an OECD Harmonised Template (OHT) as a basis to collect and structure the
data in a harmonised manner. The database is being populated by an external contractor who extracts
the relevant information from the EFSA opinions. The database contains scientific values from
EFSA’s opinions. Currently, relevant information from all opinions delivered by EFSA is already
included in the database and EFSA continues updating the database.
The EU pesticides database
2
is the official source for pesticide Maximum Residue Levels (MRLs) in
food products. It is maintained by the Commission – DG SANTE - and it contains both the current
and historical information on MRLs of pesticides with the residue definition and a coded list of
commodities to which the MRLs apply. The database contains regulatory reference values from the
relevant legislation. The Commission – DG SANTE - continues updating it.
ECHA has developed and operates the EU Chemicals Legislation Finder (EUCLEF)
3
. It is an online
service to access an overview of 56 pieces of EU chemicals legislation. The purpose of EUCLEF is
to offer users the possibility to navigate through the EU chemicals legislative framework and find
relevant information on how substances are regulated across the EU. EUCLEF was developed to help
companies who need to track their obligations across different EU laws. EUCLEF lists some
regulatory reference values derived and applicable under these legislative pieces. There might be an
overlap between information in EUCLEF and in the EU pesticides database.
Changes in the process:
ECHA establishes and operates the centralized EU repository of reference values as part of a database
with information on the provisions and legal obligations applicable to chemicals under the Union acts
by adapting the existing EUCLEF system (see section 23). Both the repository of reference values
and a dedicated service on information on the obligations under EU acts on chemicals (i.e. an
expanded EUCLEF system) are established as part of the common data platform and the governance
structure of the platform is also used to govern the development and operation of the repository of
reference values.
ECHA makes available in the repository all regulatory reference values adopted under EU chemicals
legislation (this is broader than today and contains more metadata information).
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ECHA extracts and feeds into the repository all ‘legacy scientific reference values’ from ECHA’s
opinions (i.e all reference values already derived by ECHA before the entry into force of the
regulation establishing the common data platform and which are not formally adopted under EU
legislation). For ‘new reference values’ ECHA starts providing reference values on a continuous basis
to the repository as new opinions are adopted by ECHA.
EFSA provides the collection of ‘legacy scientific reference values’ (i.e. those which are not formally
adopted under EU legislation but derived by EFSA) from the Open Food Tox to ECHA to be
integrated in the repository. For ‘new scientific reference values’ (i.e. those that are not formally
adopted under EU legislation but derived by EFSA) EFSA continues providing relevant information
on a continuous basis to the repository (or to ECHA) as new opinions are adopted by EFSA.
The Commission – DG SANTE - continues to operate and populate the EU pesticide database with
new regulatory reference values. The Commission – DG SANTE - establishes a dynamic link for
provision of the information from the EU pesticide database to ECHA to be made available also via
the repository.
EMA provides on a continuous basis to ECHA all new (i.e. adopted after entry into force of the
regulation establishing the common data platform) predicted no effect concentrations (PNECs)
derived as part of the environmental risk assessment under Directive 2001/83/EC, Regulation (EC)
No 726/2004 and Regulation (EU) 2019/6
EEA and EU-OSHA provide on a continuous basis to ECHA all new scientific reference values they
might derive in the future, as currently they do not do so.
The governance of the common data platform is used for governing the development and operation
of the repository.
Proximity to agencies’ mandate:
The tasks fit well with the mandate of each agency. EFSA, ECHA and EMA provide scientific
reference values from the assessments they perform. ECHA is already operating EUCLEF and is
tasked to operate the common data platform, so for ECHA it is an extension of its current work.
Projected synergies and added value of (re-)attribution:
Operating only one repository of reference values compared to several separate ones will save
resources. The existing IT solution and contractual arrangement available in ECHA can be reused.
Main risks and opportunities:
There might be an overlap between reference values in the repository
and in the EU pesticide database.
Projected impact on agencies
-
-
-
ECHA/EMA/EFSA committees/bodies:
low impact.
The rapporteurs of opinions might be
asked to extract the reference values and metadata for integration into the repository as part
of the finalisation of the opinion.
ECHA data model and IT infrastructure:
medium impact.
The task requires adaptation of the
EUCLEF IT solution.
EMA/EFSA data model and IT infrastructure:
low impact.
EMA and EFSA would use the
data model set by the repository. They would be reusing the IT solution provided by
ECHA. ECHA/EMA/EFSA key experts:
low impact.
Experts are needed to extract relevant
information from the opinion into the repository.
Projected workload and resource implications:
Work description
Who
Resource needs estimate
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Setting up the repository on the basis of
EUCLEF
Designing and developing the repository ECHA
as expansion of EUCLEF and as part of
the common data platform
Coordination of and consultation with
other agencies contributing to the
repository (as part of the common data
platform) during development
Development by 2028; development duration 3 years (years 2025,
2026, 2027)
One-off costs for contracting the development (to supplement IT
costs of EUCLEF):
-
2025: EUR 0
-
2026: EUR 550 000
-
2027: EUR 550 000
The IT development can be subcontracted but it will need to be
overseen/supervised by ECHA staff. The development is to be
coordinated with other agencies.
Estimated coordination for the development phase (2025-2027): 1
FTE per year
Contribution to the development phase
EMA,
EFSA,
EEA,
EU-
OSHA
COM
negligible; should be absorbed by the agencies
Operating the repository as part of
EUCLEF
Operation/hosting, maintenance and
ECHA
update of the repository as part of
EUCLEF and as part of the common data
platform
Coordination of and consultation with
other agencies contributing to the
repository (as part of the common data
platform governance)
ECHA,
EFSA,
EMA
EEA,
EU-
OSHA
COM
Recurrent costs as of 2028: EUR 200 000 and 1 FTE per
year. This is to cover the improvements and maintenance of the
repository as part of the EUCLEF and the common data platform,
contact with data providers, covering specific needs of the
repository
Recurrent resource ideally covered by the agencies’ core staff.
Negligible; should be absorbed by the agencies
Provision of data
Providing ‘new scientific reference data’ ECHA,
EFSA,
EMA,
EEA,
EU-
OSHA
Putting the data into the repository with adequate metadata
information will require some additional resources from the
agencies or from the rapporteurs of opinions. The amount will
depend on how many opinions with limit values the agency sets
per year. The work will be spread over time and could be absorbed
by the resources spent on the development of the opinion, for
example by ensuring that the opinion format has specific fields
dedicated to the limit values information.
EFSA has already compiled all ‘old scientific reference values’ in
the open food tox repository; no additional resources needed for
this;
ECHA needs to progressively extract the old scientific reference
values from their opinions. This would be a one-off exercise that
could be outsourced. The following resources for contracting will
be needed:
ECHA:
- 2026 (200 opinions): EUR 100 000
Providing ‘legacy scientific reference
values’
ECHA,
EFSA,
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- 2027 (200 opinions): EUR 100 000
- 2028: Euro 0
The management of the contract is to be done as part of the
common data platform resources
Providing ‘formally adopted regulatory
reference values’
ECHA
ECHA has already a contractual agreement for the provision of
reference values under the operation of EUCLEF. This should be
expanded to cover all formally adopted regulatory reference
values and to collate also necessary metadata.
The current EUCLEF financing related to data provision assumes
the maintenance of 51 pieces of legislation, at a cost of EUR 8
400/year for each legislation, or EUR 430 000/yearin total.
To top-up EUCLEF to cover the Eur-Lex legislations with human
health or environmental limit values in the scope of the repository,
ca 25 pieces of legislation would be added to the current scope,
amounting to an additional data provision cost of EUR 200 000
/year. This is already covered in the estimation of the resource
needs for operating and hosting the repository above.
Receiving and processing national
reference values
ECHA
A proposal for revision of water legislation requires MSs to report
national EQS to ECHA. The
resources for this part of the work
were already proposed
under the proposal for revision of water
legislation (and are thus not covered under the proposal for a
regulation establishing the common data platform).
The only other national limit values of interest are the national
occupational exposure limits (OELs). There is no legal obligation
to report those to EU institutions. The same system/set up
developed for water EQS could be used for the OELs and Member
States would be asked to report voluntarily.
No additional
resources needed.
Summary of additional resource needs for the establishment and operation of a repository of
reference values:
Agency
ECHA
Summary of tasks
Designing and developing the repository as
expansion of EUCLEF and as part of the
common data platform
Operation/hosting, maintenance and update
of the repository as part of the EUCLEF and
of the common data platform
Coordination of and consultation with other
agencies contributing to the repository (as
part of the common data platform) during
development
Providing ‘new scientific reference data’
Providing ‘old scientific reference values’
Providing ‘formally adopted regulatory
reference values’
Receiving and processing national reference
values
Financial resource
needs:
2025:
EUR 650 000
2026:
EUR 650 000
2027:
EUR 200 000
2028:
EUR 200 000
2025:
1 TA, 0 CAs
2026:
1 TA, 0 CAs
2027:
1 TA, 0 CAs
2028:
1 TA, 0 CAs
Human resource
needs:
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EFSA
Contribution to the development phase
Coordination of and consultation with other
agencies contributing to the repository (as
part of the common data platform) during
development
Providing ‘new scientific reference data’
Providing ‘old scientific reference values’
Financial resource
needs:
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2028:
EUR 0
Covered by EU common data
platform on chemicals resource
2025:
0 FTEs
2026:
0 FTEs
2027:
0 FTEs
2028:
0 FTEs
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2028:
EUR 0
Covered by EU common data
platform on chemicals resource
2025:
0 FTEs
2026:
0 FTEs
2027:
0 FTEs
2028:
0 FTEs
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2028:
EUR 0
No relevant data managed by
the agencies;
2025:
0 FTEs
2026:
0 FTEs
2027:
0 FTEs
2028:
0 FTEs
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2028:
EUR 0
Human resource
needs:
EMA
Contribution to the development phase
Coordination of and consultation with other
agencies contributing to the repository (as
part of the common data platform on
chemicals) during development
Providing ‘new scientific reference data’
(i.e. PNECs)
Financial resource
needs:
Human resource
needs:
EEA
EU-
OSHA
Contribution to the development phase
Coordination of and consultation with other
agencies contributing to the repository (as
part of the common data platform) during
development
Providing ‘new scientific reference data’
Financial resource
needs:
Human resource
needs:
DG
SANTE
Contribution to the development phase
Coordination of and consultation with other
agencies contributing to the repository (as
part of the common data platform on
chemicals) during development
Financial resource
needs:
Future budget line: DG Environment
Candidate for fees: No
23. I
NFORMATION ON THE OBLIGATIONS UNDER
U
NION ACTS ON CHEMICALS
Responsible body:
Currently: Commission, delegated to ECHA
(Re-)attribution planned to: ECHA
Legal basis for (re-)attribution:
Proposal for a regulation of the European Parliament and of the
Council establishing a common data platform on chemicals, laying down rules to ensure that the data
contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and
outlook framework for chemicals
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Type of task:
existing
Brief task overview:
Operation of a database with information on the provisions and legal
obligations applicable to chemicals under the Union acts providing a single point of entry to
information on various pieces of EU legislation applicable to a given chemical substance.
Detailed process description
Current process
EU Chemicals Legislation Finder (EUCLEF) is a database, compiled by ECHA from multiple
sources, presently covering 51 pieces of EU legislation and organized in a way that enables searching
and listing all regulations and regulatory lists in which a substance
(directly, or inheriting the
regulatory context of a parent substance)
appears. To ensure continuous relevance, the database is
regularly (several times per year) updated. Advanced searches, links to applicable documents and
exporting of aggregated results are enabled. Industry, in particular SMEs, is the principal user
addressed, as the efficient access to information on obligations reduces costs and increases
compliance.
EUCLEF is hosted by ECHA as part of its dissemination pages. EUCLEF has been developed and is
maintained by an external contractor managed by ECHA. The information in the database is regularly
updated also by the contractor who regularly searches for updates in legislative provisions, such as
Eur-Lex, and keeps the EUCLEF database up to date.
Changes envisioned as part of setting up common data platform
Database with information on the provisions and legal obligations applicable to chemicals under the
Union acts will be established as an integral dedicated service within the common data platform. The
database will be built from the existing EUCLEF. Its principle task should not change from the
existing service, but the scope of EUCLEF will be slightly extended to cover all legislation within
the scope of common data platform. In addition, EUCLEF will be reshaped to fit with the standard
data format and controlled vocabulary and graphical interface to the common data platform. Further,
EUCLEF will be expanded to integrate in it also the repository of reference values, as it partly
overlaps in scope but also in sources and approaches required to keep the information updated.
Proximity to ECHA mandate:
ECHA has the appropriate data and expertise to perform this task.
ECHA already operates the system in its current form and it fits well with the new mandate to operate
the common data platform on chemicals.
Projected synergies and added value of (re)attribution:
Type
Reuse of
capabilities
Synergies
High
ECHA’s existing processes and methodologies can be fully reused
for the new task. Eventually the service will benefit from its
position within the common data platform, exploiting capabilities
developed within it.
Reuse of data in the EU data space (Eur-Lex) and data collected
under other chemicals legislation
Existing process based on external contract. Integration
requirements will be passed through revised specification.
Reuse of existing solution, together with IT capabilities developed
in the platform. Joint revision with the new repository of reference
values.
Re-use of data
Workload
balancing
High
Low
IT tools:
High
automation
and economies
of scale
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Support
services:
economies of
scale
High
Reuse of support services within the platform (e.g. substance
identification, data management and dissemination). Reuse of
administrative services.
Type
Compliance,
robust
implementation
leading to safe
handling
Transparency
Added value
High
Facilitating a comprehensive understanding of legal frames
applying to a specific substance for its full lifecycle supports
adequate and efficient activities, implementation of legislation
and development of policies.
Compiling information that is public by default, but by merging
and by using advanced tools to visualize the information provides
a unique insight that is often missed by data alone.
High
Main risks and opportunities:
The current EUCLEF solution provided by an external consultant is robust and the risks of
interrupting the continuous provision of information and the efforts required to integrate in the
platform are low, provided that funding is maintained at a similar level as today. There is an
opportunity to allow for a more efficient update of the database by automating the reading of entries
from Eur-LEx. For that, a collaboration with the Commission’s publication office is required to
ensure adequate structuring of the information in Eur-Lex. Another opportunity is to integrate the
repository of reference values into the system, using joint efforts and practices.
Projected impact on ECHA:
•
•
ECHA committees/bodies:
no impact.
The task does not require the involvement of ECHA
committees /bodies.
ECHA data model and IT infrastructure:
medium impact.
Becoming a sustainable part of the
common data platform, it will require some changes in the data model. However, being an
existing service to be included in the platform, significant efforts in addition to continuous
funding at the existing operational level should not be required. Given the investments in IT
and data under the EUCLEF task since 2019, its continued implementation would not require
significant further efforts in this area.
ECHA key experts:
low impact.
The task relies on expert competencies, but as externally-
supported service in the operational phase this requires lower ECHA oversight, and the
additional support to development the required for integration into the common data platform
is expected to be covered by the ECHA experts dedicated to the platform development.
-
Projected workload and resource implications:
Current workload and resource use:
ECHA already developed and currently maintains the EU Legislation Finder (EUCLEF). It does so
under a Contribution Agreement with DG GROW for which it receives a varying sum of money
depending on the year (EUR 1 000 000 – EUR 1 400 000 annually), but no posts. ECHA runs the
service through the employment of 4 interim staff members (ca. EUR 270 000/year) and outsourcing
to contractors: communication activities and external helpdesk ca. EUR 60 000/year, IT costs ca.
EUR 200 000/year, data costs ca. EUR 430 000/year. Via the Contribution Agreement this activity
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does not currently contribute to the cost of running the ECHA (administrative overhead or IT
development).
Future workload and resource needs:
No additional resources are required for this work. The existing resources for EUCLEF will be used
to continue operating, further developing and slightly expanding the system. The dedicated service
on information on the obligations under EU acts on chemicals will have to be integrated into the
platform, but the resource needs for adaptation are already covered under the common data platform.
The major extension of EUCLEF – incorporation of the repository of reference values – are accounted
for separately (see section 22). Although no additional resources are required under the proposal for
the regulation establishing a common data platform on chemicals and establishing a monitoring and
outlook framework for chemicals, the legislative proposal for a regulation on ECHA that is in
preparation should address the fact that the operation of the EUCLEF became a structural task for
ECHA and that the financing should become part of the annual contribution to ECHA.
Work description
Who
Additional resource needs estimate
None, but the existing resources and financing for EUCLEF must be
maintained.
Operation of dedicated service on
ECHA
information on obligations under EU acts
on chemicals– maintaining the system,
periodically updating the database with
data
Development phase - incorporation of the ECHA
dedicated service into the common data
platform: reviewing, aligning database
structure and format; association with
controlled vocabularies (as they are being
developed)
Development phase – incorporation of
repository of reference values into
dedicated service on information on
obligations under EU acts on chemicals
ECHA
Resources required for the integration are already considered by the
estimates on EUCLEF operation (above – some level of continuous
adaptation to technical progress is part of operation) and under
common data platform ECHA common data platform data ingestion
estimation.
Resources estimated under the repository of health-based limit
values.
Summary of additional resource needs for the dedicated service on information on obligations under
EU acts on chemicals:
Agency
ECHA
Summary of tasks
Operation of dedicated service on
information on obligations under EU
acts on chemicals – maintaining the
system, periodically updating the
database
Financial resource needs:
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2028:
EUR 0
2025:
0 FTEs
2026:
0 FTEs
2027:
0 FTEs
2028:
0 FTEs
Human resource needs:
Future budget line: n/a
Candidate for fees: No
24. D
ATABASE ON ENVIRONMENTAL SUSTAINABILITY RELATED INFORMATION
Responsible body:
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Currently: N/A, no current process
(Re-)attribution planned to: ECHA, EEA, EFSA, EMA and EU-OSHA
Legal basis for reattribution:
Proposal for a regulation of the European Parliament and of the
Council establishing a common data platform on chemicals, laying down rules to ensure that the data
contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and
outlook framework for chemicals
Type of task:
new (new infrastructure but building on existing datasets)
Brief task overview:
Setting up and operation of a database on environmental sustainability related
data and providing relevant data to the database.
Detailed process description:  
Current process:
There is an increasing amount of data related to environmental sustainability of chemicals, often
generated in research and innovation projects. It is also expected that the implementation of the
European Green Deal and its various initiatives, including the implementation of the Safety and
Sustainability by Design framework for chemicals and materials, as well as regulatory initiatives such
as the Ecodesign Regulation for sustainable products and the Sustainability Corporate Reporting
Directive will further increase the availability of certain environmental sustainability data for
chemicals.
There is no ongoing process to systematically collect all relevant information on the environmental
performance of chemicals throughout their lifecycle. While there are initiatives compiling (some)
data used for sustainability assessments, in particular data needed for the life cycle assessment of
products, there are no standard data formats or controlled vocabularies for information related to
environmental sustainability, which hinders coherence between assessments of the impacts of the
same chemical on the environment.
Changes in the process: 
ECHA is to set up and operate a database on environmental sustainability related data, which is
established as part of the common pata Platform. For that purpose, ECHA extracts and feeds into the
database information from all relevant datasets already integrated in the common data platform but
also further relevant external datasets identified by the Commission.
EEA, EFSA, EMA and EU-OSHA provide to ECHA relevant data related to environmental
sustainability of chemicals they host or hold in addition to the chemicals data already available in the
common data platform.
Progressively, more data will be integrated in the database, as more data will become available in
response to the European Green Deal and the various initiatives requiring the assessment of
sustainability of materials, products and services. Further datasets presently under preparation by the
Partnership for the Assessment of Risks from Chemicals (PARC) and generated through the
implementation of the safe and sustainable by design framework should be utilised and integrated as
appropriate.
The Commission identifies existing datasets on environmental sustainability related information for
inclusion in the common data platform and designs relevant related database functionalities.
The governance of the common data platform is used for governing the development and operation
of the database.
Proximity to agencies’ mandate:
The task fits well with the mandate of each agency. ECHA has a long standing expertise on collection
of information on substances. It is a key part of ECHA’s mandate. Other agencies (EFSA, EEA, EMA
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and EU-OSHA) also collects or make available information on chemicals related to their mandate.
EEA will in the future operate the Industrial Emissions Portal that might collect some data related to
environmental sustainability of chemicals on industrial sites, including on 91 pollutants.
Projected synergies and added value of (re-)attribution: 
Operating only one database to systematically collect and relate all relevant information on the
environmental performance of chemicals throughout their lifecycle and facilitate operation of tools
and efficient assessment of environmental sustainability by different actors leads to synergies.
Main risks and opportunities: 
There is a lot of activity in the field of sustainability assessments leading to multiple and not always
coordinated activities and risks of ‘lock-in’ of specific solutions. A lot is still to be defined and agreed
in this field; even some of the concepts are still under development and testing. Precise advance
planning of solutions is therefore not possible at present. The opportunity of having a central ‘beacon’
in the form of a dedicated database around which the activities can coalesce, coordinate and
individually contribute is a major opportunity.
Projected impact on agencies
•
•
•
ECHA committees/bodies:
no impact.
There is no involvement of the committees
ECHA data model and IT infrastructure:
high impact.
The task requires the development of
an IT solution.
EMA/EFSA/EEA/EU-OSHA data model and IT infrastructure:
no or low impact.
agencies
would provide the data they host or hold.
Workload and resource implications:
Current workload and resource use:
This is a new task and there is no existing work or resources.
Future workload and resource needs:
The additional resources are needed only for ECHA for the development of the database. It is
envisaged that the majority of data to be integrated to the database will come from outside the EU
agencies, such as research consortia or companies’ reporting. The EU agencies currently do not
actively collect or receive the relevant data, and if they have any of such data, the amount of
information held is currently very limited. Therefore, the resources for provision of such data could
be absorbed by the agencies.
Work description  
Setting up the database on environmental
sustainability related data
Infrastructure setup
Consultation on database functionalities
Identification of relevant datasets already
integrated in the common data platform
Providing relevant input on environmental
sustainability related information
Who  
 
ECHA
Resource needs estimate 
 
Development during 6 years (2025, 2026,
2027,2028,2029, 2030);
ECHA: Staff 1 FTE per year
Operating the database on environmental
sustainability related data
Integrating additional datasets
EEA,
Negligible: to be absorbed by the agencies’ existing
EFSA, 
work.
EMA
EU-OSHA
 
 
ECHA
Recurrent costs as of 2030:
ECHA: Staff 1 FTE per year
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Providing relevant environmental sustainability
related information
EEA,
Negligible; should be absorbed by the agencies
EFSA, 
EMA,
EU-OSHA
Summary of resource needs for the database on environmental sustainability related data:
Agency
ECHA
Summary of tasks
Database on environmental
sustainability related data – developing,
maintaining the system, periodically
updating the database
Financial resource needs:
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2028:
EUR 0
2025:
1 TA, 0 CAs
2026:
1 TA, 0 CAs
2027:
1 TA, 0 CAs
2028:
1 TA, 0 CAs
Human resource needs:
Future budget line: DG ENV
Candidate for fees: No
25. M
ECHANISM FOR INITIATING TESTING AND MONITORING
Responsible body:
Currently: EFSA, no current process exists beyond the food sector
(Re-)attribution planned to: EFSA (as it is currently) and ECHA (for the new process for the chemical
sector beyond chemicals covered by the General Food Law)
Legal basis for reattribution:
Proposal for a regulation of the European Parliament and of the Council
establishing a common data platform on chemicals, laying down rules to ensure that the data
contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and
outlook framework for chemicals.
Type of task:
new
Brief task overview:
Commissioning scientific studies supporting the implementation and evaluation
of legislation within the mandate of ECHA
Detailed process description:
Current process:
Pursuant to the Transparency Regulation
59
, the Commission, in exceptional circumstances of serious
controversies or conflicting results, may request EFSA to commission scientific studies with the
objective of verifying evidence used in its risk assessment process. The studies commissioned may
have a wider scope than the evidence subject to verification.
At the same time, pursuant to Article 32 of the General Food Law
60
, EFSA, using the best independent
scientific resources available, shall commission scientific studies necessary for the performance of its
59
Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and
sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No
1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009,
(EU) 2015/2283 and Directive 2001/18/EC (OJ L 231 6.9.2019, p.1)
60
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the
general principles and requirements of food law, establishing the European Food Safety Authority and laying down
procedures in matters of food safety
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mission. Such studies shall be commissioned in an open and transparent fashion and EFSA shall seek
to avoid duplication with Member State or Community research programmes and shall foster
cooperation through appropriate coordination.
EFSA implements this latter obligation through regular commissioning of scientific studies managed
by the Science Studies and Project Identification and Development Office (SPIDO). The goals of
these projects are:
-
-
Enhance EFSA’s capacity to identify studies/projects benefitting regulatory processes/science
Fill knowledge gaps to ensure preparedness for:
o
Possible divergences on sensitive matters (‘verification’ studies)
o
Future risk assessment requirements dues to evolving scientific knowledge and
legislation
-
Enhance capacity building and build partnerships
If there is a request from the Commission for a verification study, the resources are used for
commissioning such study. No request has been received from the Commission so far.
The EFSA roadmap for the studies for 2022 includes specific projects on artificial intelligence, new
approach methodologies, environmental risk assessment, combined exposure to multiple chemicals.
For the years 2023 and 2024 the roadmap includes studies on evidence-based risk communication in
the EU food safety system, OMICS and bioinformatic approaches in risk assessment, new risk
assessment methodologies and harmonised animal welfare data and advancing aggregate exposure to
chemicals in EU.
New process:
EFSA will continue the operation of their mechanism to commission scientific studies, which is
focused on food sector.
ECHA will get a mandate to commission scientific studies for the performance of its mission, i.e. in
support of the implementation or evaluation of chemicals legislation within the mandate of ECHA.
The Commission will be empowered to request ECHA to commission such studies as well.
ECHA and EFSA will have to closely cooperate when commissioning scientific studies to avoid
duplication, maximise synergies and ensure coherence of safety assessments across legislation in line
with the one substance, one assessment objectives.
Proximity to agencies’ mandate:
The task fits well with the mandate of ECHA because it is focused
on the commissioning of studies which are in the mandate of ECHA.
Projected synergies and added value of (re-)attribution:
The added value of this task is that ECHA will be able to commission necessary studies and thus
improve the implementation and evaluation of the legislation within its mandate and complement the
existing mechanism for the chemicals in food sector. Synergies will be achieved by requiring
cooperation between EFSA and ECHA. In addition, ECHA will be able to create synergies with the
work it is doing in support of PARC.
Main risks and opportunities:
The main opportunity comes from joined work of ECHA and EFSA on commissioning studies,
serving the plethora of chemicals legislation and thus improving the coherence and harmonisation of
assessment methods across legislation.
Projected impact on agencies
:
•
ECHA committees/bodies:
low impact.
The task does not require the involvement of ECHA
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committees/bodies but ECHA may require input from the committees for the identification of
study needs
•
-
ECHA data model and IT infrastructure:
no impact.
This task does not have an impact on the
IT infrastructure beyond storing the project outcomes
ECHA key experts:
medium impact.
The task will rely on expert competencies, which are
limited within ECHA and the agency may need to recruit additional personnel.
Projected workload and resource implications:
Current resources allocated to similar work:
Resources allocated to EFSA for ‘food-related data generation mechanism’
Human resources for additional ad hoc studies
Toxicological studies (H2020-FP9)
Additional operational budget for additional ad hoc studies (Prediction: 16
studies a year)
4 FTEs per year
2 FTEs per year
2020: EUR 6 million
2021: EUR 10.5 million
2022: EUR 15.0 million
2023: EUR 15.0 million
2024: EUR 15.0 million
When the PARC project was initiated, 2 FTEs were allocated to ECHA to allow its engagement in
the project and support its implementation.
Future workload and resource needs:
EFSA will continue operating its data generation mechanism. The additional work required for EFSA
will be to cooperate with ECHA on commissioning studies and on joint decision-making on which
studies to commission and how to perform them. These costs should be however absorbed by the
existing resources.
It is envisaged that there will be synergies between the studies run by EFSA and by ECHA, for
example from pooling study subjects of the projects into one commissioning. It is therefore expected
that ECHA should get a lower amount of human and operational resources than EFSA. No additional
resources would be needed to follow the research projects, as such resources were already allocated
to ECHA for the PARC project.
Summary of additional resource needs for a data generation mechanism:
Agency
ECHA
Summary of tasks
Commissioning scientific studies on its
own initiative or on the request of the
Commission
Cooperating with EFSA on
commissioning studies and on joint
decision-making on which studies and
how to follow-up
EFSA
Cooperating with EFSA on
commissioning studies and on joint
decision-making on which studies and
how to follow-up
Financial resource needs:
2025:
EUR 0
2026:
EUR 1 000 000
2027:
EUR 3 000 000
2028:
EUR 5 000 000
2025:
1 TA, 0 CAs
2026:
1 TA, 1 CAs
2027:
1 TA, 1 CAs
2028:
1 TA, 1 CAs
Covered by the existing
data generation
mechanism
Covered by the existing
data generation
mechanism
Human resource needs:
Financial resource needs:
Human resource needs:
Future budget line: DG Environment
Candidate for fees: No
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26. M
ECHANISM FOR NOTIFICATION OF STUDIES
Responsible body:
Currently: EFSA
(Re-)attribution planned to: EFSA (for notifications under the General Food Law
61
), ECHA (for
notifications of studies beyond the food sector)
Legal basis for reattribution:
Proposal for a regulation of the European Parliament and of the
Council establishing a common data platform on chemicals, laying down rules to ensure that the data
contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and
outlook framework for chemicals
Type of task:
new
Brief task overview:
Operation of an on-line system for receiving and storing notification of
information on studies commissioned or carried out cby industry and contractual research laboratories
Detailed process description:
Current process:
To ensure that the EU risk assessor has knowledge of all studies performed by an applicant,
Regulation (EU) 2019/1381 (Transparency Regulation) contains a requirement to notify studies that
are commissioned or carried out in the context of the preparation of an application for approval
process in the food chain, at pre-submission phase. Information about the notified studies is made
public once a corresponding valid application has been submitted and information on it is made public
in accordance with the applicable rules on transparency. The Transparency Regulation also provides
for consequences and certain procedural requirements in the case of non-compliance.
The studies are notified by the industry commissioning them as well as by the laboratories performing
them. They are notified to EFSA and EFSA operates an online system (database) for receiving and
storing the notifications. The system has existed for since 27 March 2021 and 15 652 notifications
were received up until March 2023.
EFSA verifies the compliance with the notification requirements once the application or notification
is received in relation to which Union law contains provisions for EFSA to provide a scientific output..
This work is done automatically but requires also some manual checks.
Future process:
The obligation to notify studies would be extended from the food legislation to all chemicals
legislation except the medicinal and veterinary products. EFSA would continue to operate its existing
notifications database for notifications made under the General Food Law, while ECHA would set up
its own database for notifications of studies carried out in the context of other EU chemical legislation.
Verification of compliance with the notification requirement would be done by the actor or agency
responsible for the legislation in question (e.g. under Biocidal Products Regulation, ECHA would
verify the compliance with the notification of studies when application for authorisation for biocidal
product or biocidal active substance would be received. Also, under REACH, ECHA would verify
the compliance with the notification of studies as part of the compliance check of the registration
dossiers).
61
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the
general principles and requirements of food law, establishing the European Food Safety Authority and laying down
procedures in matters of food safety (OJ L 31 1.2.2002, p.1)
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Proximity to agencies’ mandate:
The task is very close to the EFSA and ECHA mandate. EFSA already operates a database of
notifications for the food sector. ECHA is or will be responsible for the assessment work under the
remaining legislation (i.e. legislation beyond food sector), therefore, the operation of the notification
database for the remaining legislation fits well with ECHA’s mandate.
Projected synergies and added value of (re-)attribution:
ECHA can build on EFSA’s existing expertise and experience and can thus ensure harmonised
identification of study notifications. Existing processes under the biocidal product regulation (such
as application evaluation) and under REACH (such as dossier compliance check) can be used to
include checking the compliance with the notification requirements.
Projected impact on agencies:
•
committees/bodies: EFSA -
no impact.
The task does not require involvement of EFSA
committees /bodies. ECHA –
low impact.
The task would require checking compliance with
the notification provisions by the rapporteur member of the biocidal product committee.
Data model and IT infrastructure: EFSA -
low impact.
The existing repository of studies
continues to be operated. The system will have to be linked with or incorporated into the
common data platform. ECHA –
high impact.
ECHA will need to set up a new IT
infrastructure. In addition, REACH registration will have to be adapted to facilitate the
reporting of the notification number for a submitted study.
Key experts: ECHA and EFSA -
low impact.
The task will rely on expert competencies,
which exist in the agencies.
•
-
Projected workload and resource implications:
Current workload and resource use:
The following resources were allocated to EFSA for the implementation of the notification of studies
mechanism as part of the transparency regulation:
Resources allocated to EFSA for ‘food-related notification of studies’
Register of commissioned studies
Register of commissioned studies (development and operation)
2 FTEs per year
2020: EUR 160 000
2021: EUR 280 000
2022: EUR 400 0002023: EUR
400 000
2024: EUR 400 000
Current budget line: DG SANTE
Future workload and resource needs:
ECHA will need to set up a database of study notifications and an IT interface for receiving the
notifications. The system needs to be operational within 2 years from the entry into force of the
legislation (expected mid 2027). ECHA and EFSA will have to cooperate to ensure a common
approach for the identification of information notified to both systems. ECHA will have to build an
automatic solution that requires lead registrants or applicant to include the notification number into
the registration or biocidal product dossiers, respectively, or indicate the reason why a study was not
notified. It will also require adapting the dossier format to capture the notification number or
justification, and connect the submission system to the database of study notifications. This would be
a one-off-cost of adapting the REACH IT and the biocidal products system. For setting up the system
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it is estimated that additional 3 FTEs per year will be needed and an operational budget of EUR 1 600
000 to commission the external support in the development of the system.
Once the system is set up ECHA will have to operate it, maintain it and make the necessary
adaptations. ECHA will have to provide helpdesk to reply requests of duty holders. ECHA will also
facilitate checking the compliance with the notification provisions.
For the Biocidal Products Regulation, the notification of studies would be checked for active
substance approval as part of new applications, Art 95 dossiers and renewals. It can be estimated that
there would be a need to check 50 dossiers a year (containing ca. 100 notifications). The notification
of studies would be also checked for biocidal product authorisation. In 2022, 160 applications were
received (containing ca. 45 notifications). The checks would be performed by the Member States
competent authorities, while ECHA would make available to them the summary of notifications. It is
expected that verification of notifications would not take more than 4 hours per dossier. This could
be absorbed by the overall resources dedicated by the Member States for the evaluation of the
applications, as it is marginal compared to the overall resource need for the evaluation of an
application.
For REACH, ECHA receives from lead registrants on average yearly about 3 600 updates of the
registrations and about 300 new registrations. Updates can be submitted for a variety of reasons and
may or may not contain studies. When submitted in response to an evaluation decision and when
submitted due to an increase in information requirements following an increased tonnage band, they
most likely contain new studies. Companies may also include new studies for other reasons, e.g. to
follow regulatory changes or to strengthen adaptations. The number of annually submitted new
studies from increase in tonnage band and in response to evaluation decisions is 1 400. The new
registrations are estimated to contain on average 12 studies, i.e. 3 600 studies for 300 new registrations
per year. In summary, ECHA receives on average 3 900 registrations per year (updates + new
registrations) containing some 5 000 experimental studies that would need to be notified per year.
This would result in ca. 7 500 notifications, as it is assumed that ca. 50% of studies would have to be
notified also by commercial laboratories.
Compliance with the notification-of-studies requirement would be checked as part of the registration
compliance check. ECHA checks approximately 300 registrations per year for compliance. Checking
the compliance with the study-notification requirement would not take more than 4 hours per dossier.
This would amount to 1 200 hour per year, i.e. ca 0.6 FTE. However, it is likely that registrations
selected for a compliance check would not consist of only new registrations or updated registrations
for which the requirement of notification of studies applies, and thus the number of checks for
complying with study-notifications requirements would be lower. In addition, when one is performing
a full compliance check of a registration, the additional time for checking compliance with the study-
notification requirement is negligible.
For any other legislation, ECHA might need to assist Member State authorities in their enforcement
action and for those legislative pieces, where a dossier containing studies is submitted by duty holders
to ECHA, ECHA can verify the compliance when evaluating such dossier (e.g. under RoHS directive,
there might be some 3 dossiers per year requesting derogation which potentially might contain study
results).
It is estimated that 3 FTEs per year and an operational budget of EUR 200 000 per year will be needed
for ECHA to operate the system, deal with requests from duty holders and to assist in compliance
check.
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ECHA will have to cooperate with EFSA also on the integration of EFSA’s notifications database
into the common data platform. This part of work is covered by the resources planned for the common
data platform.
Summary of additional resource needs for the mechanism for notification of studies:
Agency
ECHA
Summary of tasks
Setup and operation of notifications database and ensuring
common approach for the identification of information
notified to EFSA and ECHA system
Adaptation of the REACH registration system to include
study notifications numbers
Adaptation of the biocidal products regulation system to
include study notifications numbers
Helpdesk
Verification of compliance with the study notification
requirements as part of the REACH compliance check and
biocides authorization
Support to Member State authorities in enforcement
EFSA
Continue running its existing notifications database
Coordination with ECHA to ensure common approach for
the identification of information notified to EFSA and
ECHA systems
Financial
resource needs:
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2028:
EUR 0
2025:
0 FTEs
2026:
0 FTEs
2027:
0 FTEs
2028:
0 FTEs
Financial
resource needs:
2025:
EUR 0
2026:
EUR 1 200 000
2027:
EUR 400 000
2028:
EUR 200 000
2025:
1 TA, 2 CA
2026:
1 TA, 2 CA
2027:
1 TA, 2 CA
2028:
1 TA, 2 CA
Human resource
needs:
Human resource
needs:
Future budget line: DG Environment
Candidate for fees: No
27. EU C
HEMICAL
E
ARLY
W
ARNING AND
A
CTION
S
YSTEM
C
HEMICALS
Responsible body:
Currently: EEA, ECHA
AND
I
NDICATOR
F
RAMEWORK
FOR
(Re-)attribution planned to: EEA, ECHA in collaboration with EFSA, EMA and EU-OSHA
(expanding the task)
Legal basis for reattribution:
Proposal for a regulation of the European Parliament and of the
Council establishing a common data platform on chemicals, laying down rules to ensure that the data
contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and
outlook framework for chemicals
Type of task:
existing (Task 2) and new (Task 1)
Brief task overview:
1. Establishment and operation of an EU early warning and action system for emerging chemical
risks through developing and compiling early warning signals and drawing up summary report
to inform regulatory follow up actions
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2. Establishment and operation of the indicator framework for chemicals
Detailed process description:
Current process:
Task 1 is a new task and there is no ongoing process or activity for this task.
As regards Task 2 (framework of indicators), the EEA and ECHA are jointly developing a framework
of indicators for chemicals policy to monitor the drivers and impacts of exposure of environment and
humans to chemicals and to provide a fact base to measure the effectiveness of chemicals legislation
in protecting human health and the environment. The framework of indicators is being developed as
part of the framework of indicators for zero pollution. The indicators for chemical policies are
expected to monitor:
•
•
the drivers of human and environmental exposure to chemicals, namely the production and
use of chemicals, regulation of these activities;
the impacts of chemicals, in terms of emissions and occurrence in environmental matrices and
in humans compared against effect levels, and—where possible—their impacts on human
health and the environment;
progress with the industrial transition to safe and sustainable chemicals.
•
The framework will consist of a set of indicators that is annually updated and presented in the form
of a dashboard. EEA and ECHA plan to publish the baseline information for the first set of indicators
in 2024. The EEA and ECHA are the technical co-leads of the Commission inter-service working
group on chemicals indicators (WG8 of the Chemicals Strategy). During 2021, the working group
developed the first concept paper and agreed on the full set of candidate indicators. In 2022 the
indicators were further developed, in cooperation with the services involved. For each candidate
indicator, EEA and ECHA prepared a prototype and validated data availability, potential data
representation and interpretation. In 2023 EEA and ECHA will prepare the dashboard, conclude the
development of the indicators and case studies, as well as develop the synthesis report. EEA and
ECHA have established a data flow to quantify the selected indicators, and will continue to coordinate
work for the preparation of indicators that are expected to be available after 2024.
Changes in the process / New process:
Task 1 – early warning and action system
This is a new task. The early warning and action system will complement the implementation of the
EU legislation on chemicals by adopting a proactive and systematic approach to the identification of
emerging chemical risks. The system will consist of an annual compilation of a report summarising
the collection of early warning signals, identifying potential emerging risks from chemicals and
presenting the report and its finding to the expert working group on one substance, one assessment
for discussion and decision on the need for potential follow-up policy or regulatory action. The system
would be developed progressively. Initially, it will rely on existing early warning systems and signals,
such as the EFSA’s emerging risks exchange network (EREN), the national warning systems (e.g.
SamTox, SIGNAAL), targeted literature searches performed by EEA, as well as on relevant existing
data and information made available by EFSA, ECHA, EEA, EMA and EU-OSHA. Progressively,
more signals would be developed by the cooperating agencies (i.e. EEA, ECHA, EFSA, EMA, EU-
OSHA) and the tools for early warning signals developed by the Partnership for the Assessment of
Risks from Chemicals (PARC) would be utilised and integrated as appropriate.
The types of signals that could feed into the EU early warning and action system for emerging
chemical risks include:
•
substances on the market currently produced and used in small quantities but with high growth
potential,
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•
•
•
•
•
•
Task 2
new substances at research and development stage not yet on the market,
new scientific knowledge leading to a more critical assessment of the risk (e.g., discovery of
subtle effects or sensitive species),
New substances on the market, such as recently developed substitutes for regulated
substances,
substances for which emerging evidence raises concerns due to:
➢
improvements in the sensitivity of analytical methods,
➢
chemical mixtures/combination effects of chemicals,
➢
new toxicological evidence,
➢
newly identified exposure routes,
➢
increasing levels and scale of exposure or trends in the profile of the exposure,
➢
development of the legislation,
➢
new susceptible at-risk population or at-risk groups.
industry data (e.g., development of alternatives, production volumes)
biological signals (e.g., biodiversity loss)
This is an existing task. The framework of indicators will be maintained and further developed by
EEA in collaboration with ECHA, EFSA, EMA, EU-OSHA and the Commission. The dashboard of
indicators shall be integrated into the common data platform on chemicals and the relevant
information shall be made available as part of the report on early warnings.
Proximity to Agencies’ mandate:
The task of having a lead for the early warning system for chemicals fits well with the core mandate
of EEA, as EEA already operates a number of early warning systems for other areas (e.g. waste). The
task of co-developing the indicator framework fits well with the mandates of EEA and ECHA, as
ECHA is an agency that as part of the operation of common data platform manages access to all
chemicals related data held by other agencies and EEA already operates number of indicators as part
of its work on the assessment of the state of environment. The task of providing information/data for
the early warning system and indicator framework within their competence fits well with the
mandates of EEA, ECHA, EFSA, EMA and EU-OSHA as they collate and hold the relevant
information as part of their mandates.
Projected synergies and added value of (re-)attribution:
Attribution of the lead to EEA will provide for synergies with existing early warning systems and
with the EEA’s work on indicators, including its work on the zero-pollution indicator framework.
EEA has already been tasked to develop a framework of indicators in collaboration with ECHA. For
EEA, the lead on an early warning system can be considered as a natural expansion of its work on
indicators, as several indicators can serve also as early warning signals. In addition, EEA (and also
ECHA) are involved in the Partnership for the Assessment of Risks from Chemicals (PARC) through
which they can steer the development of the tools for early warning signals.
Projected impact on agencies:
-
EEA/ECHA/EMA/EFSA/EU-OSHA committees/bodies:
low impact.
EEA might use some
of their networks for the provision of early warning signals. No other additional impact on
committees is expected for EMA, EFSA, ECHA or EU-OSHA
EEA data model and IT infrastructure:
low impact.
The task can be implemented with
adjustments / configuration of existing data structures and IT systems.
EEA/ECHA/EMA/EFSA/EU-OSHA key experts:
low impact.
Expertise existing in the
agencies can be used for these tasks.
-
-
Workload and resource implications:
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Current workload and resource use:
Task 1 is a new task and there is no existing work or resources.
Task 2 is an existing task. Resources for this work were allocated to both
EEA and ECHA, as part of
the resource allocation under the 8th Environment Action Programme. ECHA uses 2 FTEs (1 TA and
1 CA) for the development of the chemical indicators (out of 2 FTEs allocated under the 8th EAP).
These resources are used by ECHA for the management and consolidation of databases, provision of
chemicals data in order to complete the respective emerging risk reports and contribution to chemical
policy indicators and other inputs to EEA’s work.
EEA uses 1 FTE for the work on indicators (out of
15 allocated under the 8th EAP). These resources are used by EEA for the integrated analysis of
pollution impacts on environment and health and on reporting on cross-cutting areas of the zero-
pollution ambition of the green deal, in close cooperation with ECHA and EFSA.
Future workload and resource needs:
Task 1 – Early warning and action system for emerging chemicals risks
Work description
Setting up the EU early warning and action system
Identifying and selecting existing working procedures,
setting up the necessary contacts with other agencies and
Member States experts, developing the early warning
signals available in EEA.
Compiling report on system set-up, signal generators
and data sources, working procedures and consulting the
expert group on one substance, one assessment for
feedback
EEA
Development by 2026; development
duration 2 years (2025, 2026); Resource
needs:
-
Staff 1 FTE per year
-
Operational budget EUR 300 000 in
2026
Setting up of the system and compiling
report shall be based on information
gathered from identified signal generators,
including ECHA, EFSA, EU-OSHA and
EMA.
ECHA,
EFSA,
EMA ,
EU-OSHA
Negligible: to be absorbed by the agencies’
existing work.
Who
Resource needs estimate
Providing relevant input for the setting up the early
warning and action system
Operating the EU early warning and action system
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Conduct a horizon scanning and foresight exercise,
including organising an annual workshop, to identify
early warning signals, including:
performing a literature search,
reviewing the EEA data flows on chemicals in
the environment
•
compiling the early warning signals from
collaborating EU agencies, including from
data provided by ECHA, EFSA and EMA and
EU-OSHA
•
compiling the early warning signals from
relevant initiatives, such as the EEA Eionet
network and Horizon Europe partnership
PARC
•
operating relevant early warning tools
developed under PARC.
Producing and publishing an annual report on early
warning signals and presenting it to Commission,
relevant EU agencies and Member States for decision
on potential regulatory follow up actions.
Providing relevant data and information on early
warning risks
•
•
EEA
Recurrent costs as of 2027:
-
-
Staff 1 FTE per year
EUR 150 000 per year for annual
studies for literature review, horizon
scanning, foresight and support in
systemic examination of potential
chemical risks and covering annual
workshop costs
Operating the system and compiling report
shall be based on information gathered from
identified signal generators, including
ECHA, EFSA and EMA.
ECHA,
EFSA,
EU-OSHA
EMA,
Negligible; should be absorbed by the
agencies; EFSA already operates food
related early warning system; ECHA
develops indicators and the resources
allocated for that should cover also this
activity; EMA and EU-OSHA should
contribute with the existing information they
identify.
Task 2 – Framework of indicators
There is no need for additional resources for Task 2, but the current resources need to be maintained
to ensure operation of the indicator framework.
Work description
Maintaining and further developing the
framework of indicators for chemicals
Who
EEA,
ECHA
Resource needs estimate
Resources already allocated (EEA: 1 FTEs, ECHA:
2 FTEs) No additional resources needed, but they
should be maintained
Summary of additional resource needs for early warning and action system and indicator framework
for chemicals:
Agency
EEA
Summary of tasks
Literature review, horizon scanning, foresight and
support in systemic examination of potential
chemical risks and covering annual workshop costs
Review of existing working procedures for early
warning signals for chemicals, including signal
generators.
Review of EEA data flows on chemicals in the
environment to identify early warning signals
available in EEA.
Financial
resource
needs:
Human
resource
needs:
2025:
EUR 0
2026:
EUR 300 000
2027:
EUR 150 000
2028:
EUR 150 000
2025:
1 TA, 0 CAs
2026:
1 TA, 0 CAs
2027:
1 TA, 0 CAs
2028:
1 TA, 0 CAs
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Compiling the early warning signals from
collaborating EU agencies.
Compiling the early warning signals from relevant
initiatives, such as the EEA Eionet network and
Horizon Europe partnership PARC, including with
the early warning tools developed under PARC, as
appropriate.
Producing and publishing an annual report on early
warning signals and presenting it to expert group on
one substance, one assessment.
ECHA
EMA
EFSA
EU-OSHA
Providing relevant data and information on early
warning risks within their competence.
Financial
resource
needs:
Human
resource
needs:
None, it should be
absorbed by the agency
None, it should be
absorbed by the agency
Budget line: DG Environment
Candidate for fees: No
28. O
BSERVATORY
Responsible body:
FOR SPECIFIC CHEMICALS WITH POTENTIAL CONTRIBUTION TO EMERGING
CHEMICAL RISKS
Currently: Commission, delegated to ECHA
(Re-)attribution planned to: ECHA
Legal basis for reattribution:
Proposal for a regulation of the European Parliament and of the
Council establishing a common data platform on chemicals, laying down rules to ensure that the data
contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and
outlook framework for chemicals
Type of task:
existing
Brief task overview:
Operate the observatory for specific chemicals with potential contribution to
emerging chemical risks
Detailed process description:
Current process:
ECHA operates EU Observatory for nanomaterials (EUON) that includes the following activities:
•
•
•
•
•
Dissemination and communication (webpages, newsletters, opinions) about different aspects
of nanomaterials;
Commissioning number of ‘paper’ studies every year on various aspects of nanomaterials to
fill knowledge gaps based on the proposals received from stakeholders via an open call for
proposals;
Running the NanoData nanotechnology knowledge base which periodically takes stock of
market development on nanomaterials (e.g. statistics of growth in sectors, patents, ….);
Providing service as a portal to ‘nano’ community where links to external resources (e.g.,
eNanoMapper serving as a common resource where EU-funded projects on nanomaterials and
nanotechnologies can place their results and where some tools are made available);
Operating a database that compiles data on nanomaterials from some sources, such as REACH
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registration, EU nano inventories (FR, BE) - and present it together with a slightly advanced
search functionality linked to nanoforms.
The EUON is funded by the European Commission and is hosted and maintained by ECHA.
Changes in the process:
Continue performing ‘the EUON’ activities, maintaining the principal objective of providing
transparency on selected class of materials, but modifying its remit and exploiting new infrastructure:
-
Expanding the scope to other chemicals and materials, such as complex advanced materials
or (other) materials identified through the early warning system, selected based on the
assessment by the Commission of expected need and benefit of their inclusion in the
observatory;
Using as appropriate the new data generation mechanism to commission also studies related
to nanomaterials (initially) and, later, also other selected groups of chemicals and materials;
Operating a database that compiles data on nanomaterials and making it accessible via the
common data platform to maximize integration with information from other datasets in the
platform and its utility as additional source of information, including as appropriate in work
on the framework of indicators;
ECHA to dedicate part of its dissemination effort on chemicals to nanomaterials (initially)
and other materials(later).
-
-
-
Proximity to agency mandate:
the EUON task was assigned to ECHA because it was assessed to
have the appropriate data and expertise to perform this task, this is confirmed by the fact that this
task has been successfully performed by ECHA for over more than 5 years.
Main risks and opportunities:
There are clear synergies and overlaps between EUON’s compilation
of European nanomaterial inventories (“Search for nanomaterials” section) and the future EU
common data platform on chemicals. There are also clear synergies and overlaps between
commissioning studies on nanomaterials and the new data generation mechanism. There might be
also some overlaps and synergies between the NanoData nanotechnology knowledge base and the
work on the famework of indicators and on the early warning system. The exploitation of these
overlaps is an opportunity of the reattribution of tasks proposal.
Projected impact on ECHA:
•
•
ECHA committees/bodies:
no impact.
The task does not require the involvement of ECHA
committees /bodies.
ECHA data model and IT infrastructure:
low impact.
Given the investments in IT and data
under this task since 2017, its continued implementation would not require significant
further efforts in this area. The existing databases can be integrated into the common data
platform.
ECHA key experts:
high impact.
The task heavily relies on expert competencies, which are
limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks.
•
Projected workload and resource implications:
Current workload and resources used:
The work is financed via the Contribution Agreement between ECHA and DG GROW and sometimes
additional funding from DG RTD. The contribution consists of approximately EUR 700 000 per year
(calculated as an average of contributions over the last 10 years: 2016 - EUR 900 000, 2017 – EUR
600 000, 2018 – EUR 600 000, 2019 – EUR 600 000, 2020 – EUR 828 000, 2021 – EUR 600 000,
2022 – EUR 809 000, 2023 – EUR 614 000, 2024 – EUR 619 000, 2025 – EUR 624 000). From the
contributions received, ECHA employs 3 CAs (ca. EUR 270 000) and uses ca. EUR 430 000 as an
operational budget for commissioning or the calls.
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The current resources spent by the Commission can be summarized as follows:
DG GROW – ECHA contribution agreement
Operational budget
3 FTEs
(3 CAs)
EUR 430 000 per year
Current budget line: DG GROW (SMP-COSME)
Future workload and resource needs:
Keeping it as a coherent set of services compiling and disseminating reliable information on selected
groups of materials, the Commission intends to integrate the work of the EUON into other work
streams assigned to the agency, namely operating the nanomaterials database as part of the common
data platform, commissioning certain studies through the new data generation mechanism, integrating
some signals from the NanoData nanotechnology knowledge base into the work onthe framework of
indicators and an early warning and action system, and specific dissemination into general
communication on chemicals. The scope of EUON will be also extended to other chemicals and
materials, such as complex advanced materials or (other) materials identified through the early
warning system, selected based on the assessment by the Commission of expected need and benefit
of their inclusion in the observatory
No additional resources are required for this work, but the existing resources for EUON must be
maintained. The existing resources for EUON will be used to continue operating, further developing
and slightly expanding the system. The dedicated service on information on the obligations under EU
acts on chemicals will have to be integrated into the platform, but the resource needs for adaptation
are already covered under the common data platform. Although no additional resources are required
under the proposal for the regulation establishing a common data platform on chemicals and
establishing a monitoring and outlook framework for chemicals, the legislative proposal for a
regulation on ECHA that is in preparation should address the fact that the operation of the EUON
became a structural task for ECHA and that the financing should become part of the annual
contribution to ECHA.
Summary of additional resource needs for the observatory for specific chemicals with potential
contribution to emerging chemical risks:
Agency
ECHA
Summary of tasks
Commissioning of studies on nanomaterials
and other materials potentially presenting
new emerging chemical risks (e.g., complex
advanced materials via the data generation
mechanism
Operating ‘nanomaterials’ database
Dissemination and communication on nano-
and (e.g., complex advanced) materials
Running the NanoData nanotechnology
knowledge database. Providing service to
‘nano’ community
Financial resource
needs:
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2028:
EUR 0
Human resource needs:
2025:
2026:
2027:
2028:
0 FTEs
0 FTEs
0 FTEs
0 FTEs
Budget line: n/a
Candidate for fees: No
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29. C
OOPERATION OF
ECHA
WITH OTHER
EU
AGENCIES
Responsible body:
Currently: ECHA
(Re-)attribution planned to: ECHA, expanding the existing tasks
Legal basis for reattribution:
ECHA founding regulation
Type of task:
New, expanding the existing task
Brief task overview:
1. Developing methodologies for assessment of chemicals in the fields falling within its
mission;
2. Cooperating with other agencies as regards exchange of data, defining formats and
controlled vocabularies and development of methodologies related to chemicals;
3. Preventing and solving divergent opinions on chemicals with EFSA and EMA.
Detailed process description:
Current process:
Task 1
ECHA has some very specific tasks with some relevance to the development of methodologies
mentioned in the current founding provisions under REACH. The Article 77 of REACH on the
tasks of the Agency lists the following tasks:
•
providing technical and scientific guidance and tools where appropriate for the
operation of this Regulation in particular to assist the development of chemical safety
reports (in accordance with Article 14, Article 31(1) and Article 37(4)) and application
of Article 10(a)(viii), Article 11(3) and Article 19(2) by industry and especially by
SMEs; and technical and scientific guidance for the application of Article 7 by
producers and importers of articles;
providing technical and scientific guidance on the operation of this Regulation for
Member State competent authorities and providing support to the helpdesks established
by Member States under Title XIII;
providing advice and assistance to manufacturers and importers registering a substance
in accordance with Article 12(1);
preparing explanatory information on this Regulation for other stakeholders;
keeping a Manual of Decisions and Opinions based on conclusions from the Member
State Committee regarding interpretation and implementation of this Regulation;
•
•
•
•
ECHA however lacks the mandate and obligation to develop methodologies for the assessment
related to chemicals. This disadvantages the ECHA as compared to other agencies and does
not allow ECHA to actively participate or contribute to the development of assessment
methods.
Task 2
The ECHA founding provisions under REACH contain provisions related to cooperation. The
Article 110 of REACH on the relations with relevant community bodies states:
•
The Agency shall cooperate with other Community bodies to ensure mutual support in
the accomplishment of their respective tasks in particular to avoid duplication of work.
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•
•
•
The Executive Director, having consulted the Committee on Risk Assessment and the
European Food Safety Authority, shall establish rules of procedure concerning
substances for which an opinion has been sought in a food safety context. These rules
of procedure shall be adopted by the Management Board, in agreement with the
Commission. This Title shall not otherwise affect the competences vested in the
European Food Safety Authority.
This Title shall not affect the competences vested in the European Medicines Agency.
The Executive Director, having consulted the Committee on Risk Assessment, the
Committee on Socio-economic Analysis and the Advisory Committee on Safety,
Hygiene and Health Protection at Work, shall establish rules of procedure concerning
worker protection issues. These rules of procedure shall be adopted by the Management
Board, in agreement with the Commission.
This Title shall not affect the competences vested in the Advisory Committee on Safety,
Hygiene and Health Protection at Work and the European Agency for Health and Safety
at Work.
The existing provisions are rather general. In order to achieve the one substance, one
assessment ambition, it is necessary to strengthen the provisions on cooperation and make them
coherent with the provisions of other EU Agencies.
Task 3
ECHA founding regulation specifies provisions for preventing and solving divergent scientific
opinions with other agencies. Article 95 on conflicts of opinion with other bodies states:
•
•
The Agency shall take care to ensure early identification of potential sources of conflict
between its opinions and those of community law, including Community Agencies,
carrying out a similar task in relation to issues of common concern.
Where the Agency identifies a potential source of conflict, it shall contact the body
concerned in order to ensure that any relevant scientific or technical information is
shared and to identify the scientific or technical points which are potentially
contentious.
Where there is a fundamental conflict over scientific or technical points and the body
concerned is a Community Agency or a scientific committee, the Agency and the body
concerned shall work together either to solve the conflict or to submit a joint document
to the Commission clarifying the scientific and/or technical points of conflict.
•
The provisions need to be aligned with those for other agencies. In addition, there is a need to
strengthen the requirement to solve the divergent view by agencies among themselves, before
the matter is referred to the Commission to be solved.
Future process:
Task 1:
ECHA should have a mandate to develop methodologies for the assessments related to
chemicals it performs based on its needs. It should have also a mandate similar to EFSA to
promote and coordinate the development of uniform risk assessment methodologies in the
fields falling within its mission.
Task 2:
ECHA actively cooperates with EFSA, EEA and EMA as regards:
-
exchange of data on chemicals and defining formats and controlled vocabularies for
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-
such data
development of methodologies related to chemicals.
The cooperation is foreseen both ways,
i.e.
when ECHA itself makes some development in
those specified areas within its domain as well as when EFSA, EEA and EMA make some
development in those areas within their domains. The goal is to ensure coherence, consistency
and interoperability in the specified areas.
Task 3:
ECHA and body concerned shall first attempt to solve the divergent opinion on scientific or
technical issues by themselves. They shall revert the decision to the Commission only if they
were not able to solve the issue. In addition, if the divergence come from divergence in hazard
assessment, the Commission should request ECHA to prepare a proposal for harmonised
classification under the CLP regulation.
Proximity to Agency mandate:
The tasks fit well with the mandate of ECHA as all three tasks
target the areas of the ECHA mandate, and they are just improvement, specification or
expansion of existing tasks.
Projected synergies and added value of reattribution:
Improving coherence, consistency
and interoperability among the Agencies work is the key added value.
Projected impact on ECHA:
•
•
•
ECHA Committees/bodies:
low impact.
The task might require some ad hoc
involvement of committee/panels or their consultation.
ECHA data model and IT infrastructure:
low impact.
The task can be implemented
with adjustments / configuration of existing data structures and IT systems
ECHA key experts:
low impact.
The task relies on expert competencies, but the task is
limited and spread over time in its nature.
Workload and resource implications:
Future workload and resource needs:
The work on the new tasks is limited and spread over time in it is nature. On a need basis, it
requires that ECHA will develop methodologies for the assessment it performs as regards
chemicals. The development and setting the methodology is a standard practice for whoever
performs the assessments, so this task can be seen as a formalisation of existing ECHA work.
There is no need for additional resources for this task.
ECHA will need to cooperate with EFSA, EEA and EMA in the areas on data, formats and
methodologies. The need for additional resources for cooperation on these are already covered
under the legislative proposal on data (operation of common data platform) or they are already
within the mandate of ECHA. Consequently, there is no need for additional resources on this
general formal mandate for ECHA to cooperate.
ECHA will need to try to solve any divergence in technical or scientific issue with the other
agency. ECHA already has such obligation in the existing regulation. The new task will require
that the agencies make more effort to solve the issue among themselves, instead of just
forwarding the problem to the Commission. Although it might require slightly higher amount
of work by the agency as compared to today, such situations are rare and therefore this can be
absorbed by the agency without any additional resources.
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Summary of additional resource needs for cooperation of ECHA with other EU Agencies:
Agency
ECHA
Summary of tasks
- Development of methodologies for
assessments related to chemicals within its
missions
- Cooperation with EFSA, EEA and EMA on
issues related to chemicals
- Preventing and solving divergent opinions or
assessments
Financial resource
needs:
2024:
EUR 0
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2028:
EUR 0
2024:
0 FTE
2025:
0 FTE
2026:
0 FTE
2027:
0 FTE
2028:
0 FTE
Human resource
needs:
Future budget line: DG GROW
Candidate for fees: No
30. S
CIENTIFIC OPINIONS ON OCCUPATIONAL EXPOSURE LIMITS
Responsible body:
Currently: Commission, delegated to ECHA
(Re-)attribution planned to: ECHA
Legal basis for reattribution:
ECHA founding regulation
Type of task:
existing
Brief task overview:
Assessments underpinning setting the EU occupational exposure levels
Detailed process description:
Current process:
Occupational exposure limit (OEL) values are adopted under two legal frameworks (Chemical
Agents Directive (CAD) and Carcinogens and Mutagens Directive (CMD)) that form an
integral part of the EU’s mechanism for protecting the health of workers. In addition, there is
a specific directive on asbestos that includes an OEL for this substance. Occupational exposure
limits adopted by the EU need to be integrated into the national legislative framework.
ECHA and its Committee for Risk Assessment (RAC) have been supporting the European
Commission’s Directorate-General for Employment, Social Affairs and Inclusion (DG EMPL)
by providing scientific opinions on OELs since 2019. This work was previously carried out by
DG EMPL’s Scientific Committee on Occupational Exposure Limits (SCOEL).
Following the request from DG EMPL, ECHA prepares a scientific report for its Committee
for Risk Assessment (RAC) based on the available scientific data and any relevant information
collected through a 90-day call for evidence. The scientific report is subject to a 60-day open
consultation. RAC then develops its opinion based on a review of ECHA’s scientific report and
the information provided during the consultation. ECHA’s scientific report becomes an integral
part of RAC’s opinion and forms an annex to the opinion. The adopted final RAC opinion is
then forwarded to DG EMPL.
DG EMPL will discuss RAC’s report in the tripartite Working Party on Chemicals. This
working party prepares a draft opinion on the proposed occupational exposure limit, which is
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then presented to the tripartite Advisory Committee on Safety and Health for adoption. In the
end, the Commission adopts a legislative proposal. For binding OELs, this happens through
the ordinary legislative procedure for adoption by the Council and the European Parliament.
For indicative OELs, it happens through a Commission directive.
Change in the process: No
Proximity to ECHA mandate:
The task is currently already performed by ECHA via an
Service Level Agreement (SLA) and is a good fit with its core mandate.
Main risks and opportunities:
Resources in ECHA staffing are a limiting factor to do more
OELs proposals. Capacity of the RAC secretariat is also a limiting factor.
Projected impact on ECHA:
•
•
•
ECHA Committees/bodies:
high impact.
The task generates major impact on the setup
/ organisation / staffing of Committees/bodies due to the (additional) workload
ECHA data model and IT infrastructure:
low impact.
The task can be implemented
with adjustments / configuration of existing data structures and IT systems
ECHA key experts:
high impact.
The task heavily relies on expert competencies, which
are limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks
Workload and resource implications:
Current workload and resources used:
The number of RAC opinion on OELs varies between 0 and 3 opinions per year, with average
of 1.5 opinion per year.
Number of RAC opinions on OELs per year
RAC opinion on
Occupational
limits (OELs)
exposure
2016
0
2017
2
2018
3
2019
0
2020
2
2021
2
2022
ECHA provides scientific advice for the setting of Occupational Exposure Limits under a
Service Level Agreement (SLA) with DG EMPL. To assess 5 substances annually, ECHA
receives 4 CA posts and in total EUR 975 000 that includes resources for those 4 CA posts.
The current resources spent by the Commission can be summarized as follows:
DG EMPL – ECHA Service Level Agreement
Operational budget
4 FTEs
(4 CAs)
EUR 575 000/year
Through the SLA this activity does not currently contribute to the staff cost of running the
Agency, although it contributes to Infrastructure and Operational costs (administrative
overhead or IT development).
Current budget line: Budget line of DG EMPL
Future workload and resource needs:
The Commission intends to stop the arrangement via a SLA and formally assign this task to
ECHA by enshrining it in its mandate. The normal resource needs for REACH restriction
dossier, which includes also socio-economic assessment and SEAC opinion is 1 (light dossier)
- 1.5 (complex dossier) FTEs. As the OEL derivation does not require socio-economic
assessment nor SEAC opinion and is principle lighter than restriction dossier, the average
resource needs for one OEL is 0.8 FTEs. The Commission wishes to get at least 5 OELs per
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year, which requires at least 4 FTEs per year. Overhead of 15% is required to contribution for
common component of IT tool development (data submission, processing, output), which is
additional 0.6 FTE, and overhead of 15 % is required to contribution for horizontal support
(governance, enablers, administrative overhead), which is additional 0.6 FTE. In total, it makes
5.2 FTEs
Summary of resource needs for scientific opinions on OELs:
Agency
ECHA
Summary of tasks
Preparation of 5 dossiers/year with proposal
for OEL
Public consultation
RAC opinion on the 5 dossiers per year and
input from the public consultation
Human resource
needs:
Financial
resource needs:
2024:
EUR 0
2025:
EUR 0
2026:
EUR 200 000
2027:
EUR 200 000
2028:
EUR 200 000
2024:
0 TA, 0 CA
2025:
3 TA, 2 CA
2026:
3 TA, 2 CA
2027:
3 TA, 2 CA
2028:
3 TA, 2 CA
Future budget line: DG Employment
Candidate for funding: No
31. REACH
REGULATION
(1907/2006)
Responsible body:
Currently: ECHA
(Re-)attribution planned to: ECHA (changes in tasks)
Legal basis for reattribution:
Revision of REACH regulation
Type of task:
New or modified existing tasks
Brief task overview:
1.
2.
3.
4.
5.
Registration
Authorisation
Restriction
Evaluation
Enforcement
Detailed process description:
Change in the process: Yes
Task 1 Registration
Additional information requirements are foreseen to enable the identification and regulation of
substances, in particular:
•
•
endocrine disruptors and persistent substances, for which new hazard classes have been
recently created in the CLP Regulation;
polymers will be added to the scope of REACH (notification obligation for all
polymers, registration only for those polymers which are more likely to be hazardous);
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•
•
chemical safety assessment will be made stricter through a so-called “mixture allocation
factor” to take into account multiple exposure to different chemical substances (so
called “cocktail effect”). It will initially only apply to high tonnage substances and with
some opt-out possibilities under certain conditions only and if specific risk assessments
taking into account multiple exposure are not already provided in the registration
dossier;
a chemical safety assessment will be required for substances in the 1-10 tonnage band.
Task 2 Authorisation
REACH authorisation, with its system of applicant by applicant decisions on allowing or not
the use of the concerned substances, will be replaced by a simpler, less granular system. Details
are still under discussion and include considerations of establishing a system calling for early
information on use, exposure and alternatives, notably from downstream uses, to inform the
decision on the best regulatory approach per substance.
Additionally, the concept of essential uses will be implemented to take into account the needs
of society (essential uses) or push to faster phase-out of substances for non-essential uses.
Task 3 Restriction
Where risks are obvious, simpler restriction procedures in the so-called “Generic Risk
management Approach” (GRA) will be extended from CMRs to new hazard classes and from
consumer to professional uses.
Likewise the authorisation process, the essential use concept will be implemented to derogate
essential uses from the restrictions by taking into account the needs of society (essential uses)
or to push for faster phase-out of substances for non-essential uses.
Task 4 Evaluation
Several provisions related to dossier and substance evaluation and its decision-making will be
modified to enhance efficiency of the processes and re-focus attention of testing proposal
examinations from volume-considerations to animal testing and complex studies. Annually
adopted Community Rolling Action Plan will be replaced with lightweight registry of
substance evaluations that would be justified based on hazard or risk considerations. ECHA
will also be able to perform substance evaluation alongside MS competent authorities.
Task 5 Enforcement
A number of actions is foreseen, which include revoking registration in case of persistent
incompliance or expiry of the technical dossier, Commission audits of Member States’
enforcement systems, improving customs controls, enabling OLAF to investigate breaches of
REACH, improving access to justice and dealing with online sales from third countries to
consumers.
Proximity to ECHA mandate:
The tasks are core tasks already performed by ECHA and
therefore there is a good fit with its core mandate.
Projected impact on ECHA:
•
•
ECHA Committees/bodies:
low impact.
The changes in the tasks on restriction and
authorisation may slightly reduce the workloead of the committees
ECHA data model and IT infrastructure:
medium impact.
The task can be implemented
with adjustments / configuration of existing data structures and IT systems
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•
ECHA key experts:
high impact.
The task heavily relies on expert competencies, which
are limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks
Workload and resource implications:
Current workload and resources used:
Current budget line: Budget line of DG GROW
Future workload and resource needs:
Task 1 Registration
Changes in Uses and exposure will require:
•
•
Unquantified costs to ECHA to update guidance and IT tools (one-off direct
administrative costs);
EUR 160 000 costs to ECHA for additional manual Technical Completeness Check
(recurrent direct administrative costs).
Changes on registration requirements for polymers:
The impact assessment estimates that the registration of polymers will entail additional EUR
141 million for ECHA (one-off direct administrative costs). ECHA has provided a more
detailed breakdown of costs and FTEs, according to their own estimates:
•
•
•
•
 
Activity
Capacity
Notification
Grouping
Capacity building and guidance development (industry and authority): 5-10 FTE
annually from 2024 until 2033, EUR 0.9-1.5 million
Notification, incl. support to industry: 10-15 FTE in 2027, 10-20 FTE in 2028, 2029
and 2030, and 10-15 FTE in 2031, marginal onwards, EUR 3 million
Developing grouping criteria: 5-10 FTE annually from 2029 to 2032, EUR 1.5-2
million
Registration, incl. support to industry: between 10 and 60 FTE annually from 2031
onwards, EUR 4-5 million
 
2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 2037 2038
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
unit  
FTE 5-10 5-10 5-10 5-10 5-10 5-10 5-10 5-10 5-10 5-10  
FTE  
FTE  
 
 
 
 
 
 
10-
15
 
 
15-
25
10-20 10-20 10-20 10-15 small small small
 
 
5-10 5-10 5-10 5-10  
 
 
 
Registration FTE  
Total (app)
10-15 15-20 30-45 35-65 35-60 35-65 35-60 25-35
FTE 5-10 5-10 5-10
15-30 20-40 20-40 30-50 25-40 35-55 35-65 35-60 35-65 35-60 25-35
Capacity
Euro  
€ 0.9-1.5 million
 
 
 
 
 
 
 
 
 
€ 3 million
 
 
€ 1.5 - 2 million
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notification Euro  
Grouping
Euro  
Registration Euro  
€ 4 - 5 million
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Task 2 Authorisation
No change in resource needs expected as a result of the revision
Task 3 Restriction
No change in resource needs expected as a result of the revision
Task 4 Evaluation
Required evaluation resources are to an important degree proportional to the registration
situation (number of registrations, changes to information requirements) and the ambition level
applied (compliance check strategy
e.g.
number of compliance checks).
While an assessment of currently ongoing Joint Evaluation Action Plan is only expected at its
finalisation in 2027, until which time the current ECHA resources for evaluation are required
at current level, it is generally considered that afterwards the proportion of resources working
on present and incoming registrations would be freed. On the other side, additional resources
to assess and address efficiencies in new polymer registrations will be required after 2031 (see
above).
While no quantified resource estimate could be made for the application of revocation
processes and efficiency measures, it is considered that new needs are offset by the efficiency
gains during evaluations and in their follow-up. Similar would apply for the expected increase
in testing proposals but ability for a lighter process. The exception is required additional
resource for ECHA’s contribution to substance evaluations.
Agency Summary of tasks
ECHA
Dossier and substance Evaluation:
Resource needs
Note: these are
additional resource
•
ECHA’s contribution to substance
2027
needs for the
evaluations is expected at the level of
onwards: 4.5
ongoing processes
contribution of a larger Member State
FTE
(e.g. 3 substances/year, estimated to
require 4.5 FTE
3
)
The evaluation processes are closely tied with the Member State Committee, whose main task
is to assess the evaluation decisions. The changes will not require new capacity or change the
nature of the work. The number of evaluation decisions to be taken is not expected to
importantly change (within +-20%); any increase in testing proposal examination decisions
that might come would be associated with likely more simple content from lower tier animal
testing.
Task 5 Enforcement
External Audit Capacity:
•
Costs for ECHA Secretariat for Audit Capacity concerning REACH only, in the range
of 0.1 to 0.13 FTE, i.e. from 21.5 working days to 29, which would amount to annual
costs for ECHA Secretariat between around EUR 11 481 to 15 486 (recurring annual
costs).
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•
•
Costs for ECHA Secretariat for External Audit Capacity covering REACH and CLP, in
the range of 0.1 to 0.15 FTE, i.e. from 21.5 working days to 32, which would amount
to annual costs for ECHA Secretariat between around EUR 11 481 to 17 088 (recurring
annual costs), or EUR 225 000 to 335 000 over 30 years. These are related to
administrative support to discussions in Forum that may take place in relation to
Commission audits of MSs control systems.
Forum: some costs will be incurred as it can be expected that in some Forum meetings
(maybe once per year) an agenda point may be included to discuss either the
Commission programme for audits or the outcome of audits/controls carried out by the
Commission.
Customs:
•
Costs for ECHA Secretariat to make the interconnection, under the responsibility of the
Commission, of ECHA electronic systems with national single window environments
for customs through the EU Single Window Environment for customs, for the
automated controls of registrations, authorisations (and restrictions). The budget is
estimated at about EUR 100 000.
The workload in ECHA to handle this development, its maintenance, and potentially
the updates of company accounts by importers and only representatives (around 14
000), the inquiries from companies, as well as the support to the work of the ECHA
Forum triggered by these new measures is estimated together at around 1,6 FTEs
•
The resource needs for the implementation of the revised obligations under REACH should be
absorbed by the existing resources for REACH and CLP.
Summary of resource needs for REACH revision:
Agency
ECHA
Summary of tasks
Implementing
•
Registration,
•
Authorisation
•
Restriction
•
Evaluation
•
Enforcement
Financial resource
needs:
2024:
EUR 0
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2028:
EUR 0
2024:
0 TA, 0 CA
2025:
0 TA, 0 CA
2026:
0 TA, 0 CA
2027:
0 TA, 0 CA
2028:
0 TA, 0 CA
Human resource
needs:
Future budget line: DG GROW
Candidate for funding: No
32. C
OSMETIC
P
RODUCTS
R
EGULATION
Responsible body:
Currently: Commission with the support of the SCCS committee
(Re-)attribution planned to: ECHA
Legal basis for reattribution:
revision of the Cosmetic Products Regulation (1223/2009)
Type of task:
existing
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Brief task overview:
(1) Safety assessment of chemicals used as ingredients in cosmetic products underlying the
authorisation of colorants, preservatives and UV-filters
(2) Opinion to the Commission underlying the prohibition or restriction of substances
where concerns are raised due to potential risk to human health
(3) Safety assessment of chemicals, classified as CMR, used as ingredients in cosmetic
products, when an application for exemption was introduced,
(4) Opinion to the Commission on the safety of nanomaterials
(5) Preparation of Notes of Guidance for the testing of cosmetic ingredients including
nanomaterials, non-animal testing methodology, and their safety evaluation
Detailed process description:
Current process:
The Cosmetic Products Regulation requires that the responsible persons and, under certain
circumstances, the distributors of cosmetic products notify electronically their products before
placed on the European market through the Cosmetic Products Notification Portal (CPNP). The
information to be submitted is specified in Article 13 as follows:
-
-
-
-
-
-
-
-
the category of cosmetic product and its name or names, enabling its specific
identification;
the name and address of the responsible person where the product information file is
made readily accessible;
the country of origin in the case of import;
the Member State in which the cosmetic product is to be placed on the market;
the contact details of a physical person to contact in the case of necessity
the presence of substances in the form of nanomaterials, and their identification
including the chemical name (IUPAC) and other descriptors and the reasonably
foreseeable exposure conditions;
the name and the Chemicals Abstracts Service (CAS) or EC number of substances
classified as carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1A
or 1B, under Part 3 of Annex VI to Regulation (EC) No 1272/2008;
the frame formulation allowing for prompt and appropriate medical treatment in the
event of difficulties.
The CPNP is accessible to competent authorities, European poison centres, cosmetic products
responsible persons and distributors of cosmetic products.
The Cosmetic Products Regulation requires that a cosmetic product made available on the
market shall be safe for human health when used under normal or reasonably foreseeable
conditions of use. In order to demonstrate that, the responsible person shall, prior to placing a
cosmetic product on the market, ensure that the cosmetic product has undergone a safety
assessment on the basis of the relevant information and that a cosmetic product safety report is
set up in accordance with Annex I. The Commission shall adopt appropriate guidelines to
facilitate, in particular SMEs, to produce the cosmetic product safety report.
Taking into consideration the impact of the chemical ingredients on human health, the
Cosmetic Products Regulation lays down limitations and requirements for the use of substances
in cosmetic products. The rules are listed in Articles 14-17 and the following annexes:
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•
•
•
•
•
Annex II
-
List of substances prohibited in cosmetic products
Annex III
-
List of substances restricted in cosmetic products
Annex IV - List of colourants allowed in cosmetic products
Annex V - List of preservatives allowed in cosmetic products
Annex VI - List of UV filters allowed in cosmetic products
Certain groups of substances, i.e. colorants, preservatives and UV-filters must be authorised by
the Commission, i.e. placed on the respective annex (IV, V or VI), prior to their use in cosmetic
products. Certain subtances are prohibited (Annex II) and cannot be used in cosmetic products
and certain substances are restricted (Annex III) and they can be used only when fulfilling the
conditions of the restriction.
The safety assessment of the cosmetic ingredients (substances) in the EU is performed by the
Scientific Committee on Consumer Safety (SCCS). It is based on safety dossiers submitted by
applicants (individual company/associations or by competent authorities) or by the
Commission. Based on its opinions, Commission may decide to amend the relevant Annexes.
The safety of cosmetic products with all their ingredients is evaluated by “a person in
possession of a diploma or other evidence of formal qualifications awarded on completion of
a university course of theoretical and practical study in pharmacy, toxicology, medicine or a
similar discipline” (Article 10(2) of the Cosmetic Products Regulation) before placing them
on the EU market.
Task 1: Process for the authorisation of colorants, preservatives and UV-filters (including in
nano forms) is as follows:
1. The amendment of the annexes IV, V or VI of the Cosmetic Products Regulation and
associated technical and scientific work is initiated by the submission of a safety
dossier by economic operators (applicant) to the Commission.
2. Commission evaluates the completeness of the dossier and prepares a mandate to the
SCCS.
3. SCCS performs a risk assessment (9-12 months). The preliminary Opinion is
published and open for comments (4-8 weeks) before being finalised. A final opinion
is published on the SCCS’ website.
4. Commission prepares a Working Document based on the final SCCS Opinion and
shares it for discussion with the members of the Working Group on Cosmetic
Products (participants: MS, Industry, SMEs and civil society organisations).
5. Commission prepares a Draft Regulation.
6. Draft Commission Regulation is discussed with the Standing Committee on Cosmetic
Products, which comprises of MS authorities and the Commission.
7. TBT notification is launched with a commenting period of 2 months.
8. MS vote in the Standing Committee on Cosmetic Products (comitology) on the draft
Commission Implementing Regulation.
9. Scrutiny period by the Council and the European Parliament of 3 months.
10. Adoption of the Regualtion by the Commission and publication in the Official Journal
of the EU.
Task 2: Process for prohibition or restriction of a substance used in cosmetic products where
concerns are raised due to a potential risk to human health is as follows:
1. The Commission may amend the annexes II and VI of the Cosmetic Products
Regulation (CPR) if concerns for human health due to the use of a substance in
cosmetics were raised by e.g. Member States, economic operators (industry, SMEs) or
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civil society organisations (NGOs).
2. The Commission evaluates the information/data gathered and prepares a mandate to
the SCCS.
3. SCCS performs a risk assessment (9-12 months). The preliminary Opinion is
published and open for comments (4-8 weeks) before being finalised. A final opinion
is published on the SCCS’ website.
4. The Commission may prepare a Working Document based on the final SCCS
Opinion and share it for discussion with the members of the WG on Cosmetic
Products (participants: MS, Industry, SMEs and civil society organisations).
5. The Commission prepares a Draft Regulation.
6. The draft Commission Implementing Regulation is discussed with the Standing
Committee on Cosmetic Products.
7. TBT notification is launched with a commenting period of 2 months.
8. MS vote in the Standing Committee on Cosmetic Products (comitology) on the draft
Commission Implementing Regulation.
9. Scrutiny period by the Council and the European Parliament of 3 months.
10. Adoption of the Regualtion by the Commission and publication in the Official Journal
of the EU
Task 3: The use of CMR substances (category 1A, 1B, or 2 under CLP) is prohibited in
cosmetic products, apart from “exceptional” cases. This prohibition is implemented by
amending Annex II-VI of the Regulation. Once a substance receives its harmonised
classification as CMRs cat 1A, 1B or 2 under CLP regulation, the Commission must update
the annexes of the CPR within 15 months. There is no involvement of SCCS in this process, as
there is no safety assessment performed except in the case of derogation requests. Economic
operators can, on a voluntary basis, prepare and submit safety dossiers to defend the use of a
substance in cosmetics. In such a case the Commission can launch ‘calls for data’ in order to
acquire as much information as possible for a full risk assessment.
If there is a request from industry for derogation, then the Commission mandates the SCCS to
perform a safety assessment and following the outcome of the SCCS assessment the
Commission may amend Annexes III - VI.
Task 4: Cosmetic products containing nanomaterials
other than
colourants, preservatives and
UV-filters require a specific notification on the CPNP 6 months
before
they are placed on the
market. If the Commission has concerns regarding the safety of a nanomaterial, it may request
the SCCS to perform a risk assessment. The SCCS may also use information gathered from
published literature and/or received from other stakeholders as a result of the Commission's
call for data. The SCCS has 6 months to deliver its final opinion. In cases where further
data/clarifications are needed, the 6-months clock starts again once the necessary
data/information is provided by the applicant.
Task 5: The SCCS, with involvement of the Commission updates approximately every other
year a technical guidance document concerning different aspects of testing and safety
evaluation of cosmetic substances (called SCCS Notes of guidance’). The emphasis of this
guidance is on cosmetic ingredients, including nanomaterials although some guidance is also
indirectly given for the safety assessment of finished products. It is designed to provide
guidance to public authorities and to the economic operators (safety assessors) to improve
harmonised compliance with the current cosmetic EU legislation.
Administrative support for the SCCS
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The SCCS is currently managed by DG SANTE within the Commission, which provides
secretariat services for the committee. The Secretariat is responsible for providing scientific
and administrative support necessary to facilitate the efficient functioning of the Committee,
to monitor compliance with the Rules of Procedure, particularly in relation to the requirements
for excellence, independence, commitment, confidentiality and transparency, to ensure
communication on the Committees' activities, the appropriate stakeholder dialogue, publication
of the opinions and other relevant documents. Moreover, the Secretariat provides support to
the Committee and organises and applies quality control of the opinions as far as completeness,
consistency, clarity, correspondence with requests and with editorial standards are concerned.
Further tasks can be found in the rules of procedure.
Changes in the process:
It is envisaged that the SCCS will become part of ECHA, and therefore ECHA will take over
the secretarial tasks of the committee. It is important that the flexible arrangements are put in
place to allow the best integration of the SCCS in ECHA and, in particular, in view of any
future reorganisation of the Agency’s bodies, that would take into account the experience with
SCCS work in ECHA and the need to increase the capacity of the existing committees in ECHA
as a consequence of number of reattributions.
In view of the targeted revision of the CPR, apart from CMRs, additional hazard classes will
be subject to risk management measures covering substances classified as endocrine disruptors,
and the separate process will be established to examine the safety of substances that could
affect the respiratory system and chemicals toxic to a specific target organ toxicant (STOT),
which will also require the safety assessment by the SCCS. This is expected to result in a
significant increase in the workload of the SCCS and the supporting work of the ECHA’s
secretariat.
Proximity to ECHA mandate:
The risk assessment of chemicals including data management
and facilitating the work of committees is a core part of the ECHA mandate. The task is
therefore closely related to ECHA’s core mandate and ECHA has the needed data, competences
and expertise to perform the task. Synergies could be achieved if the work of the SCCS
committee would be translocated into ECHA, both in terms of efficiencies, as in terms of
coherence of scientific opinions.
Projected synergies and added value of reattribution:
Type
Reuse of
capabilities
Synergies
High
Process and expertise: ECHA already performs similar work
on restrictions, derogations and setting of limit values under
REACH and other legislation. Several key capacities can be
reused/reinforced:
-
-
-
-
Hazard, risk and exposure assessment
Exposure limit value definition
Committee opinion development
Existing IT capabilities for industry dossier
submission, stakeholder consultation and
dissemination
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Re-use of data
High
Reuse of data collected under other chemical legislation,
especially REACH & CLP, with a focus on CMRs endocrine
disruptors or other hazardous chemicals.
With an estimated workload of 11 opinions to be worked on in
parallel, there is little room for workload balancing.
Industry actors can submit their derogation requests reusing
existing ECHA submission tools, at the same time automating
the existing process. In addition, reuse of IT capabilities for
case management, public consultation, interaction with
Member States, regulatory intentions management and data
dissemination.
Reuse of scientific support services (e.g. committee
secretariat, prioritisation and grouping of substances,
substance identification, data management and dissemination).
Reuse of administrative services.
Workload
balancing
IT tools:
automation
and
economies of
scale
Support
services:
economies of
scale
Low
High
High
Type
Scientific
consistency
Added value
High
Opportunity to align priority setting, timeline, process and
methodology with other related legislation to improve
coherence in the scientific advice provided to the
Commission. Reuse of data collected under other chemical
legislation. Opportunity to promote risk assessment
methodologies based on non-animal data beyond cosmetic
area.
Moving the SCCS and its tasks to the European Chemicals
Agency will continue ensuring the strict separation between
science and policy. ECHA and its committees work under
strict conflict of interest avoidance rules, improving
guarantees of independent scientific advice to the
Commission.
ECHA’s involvement will bring additional transparency to the
process:
-
-
-
-
-
Overall process transparency
Publication of regulatory intentions of EU authorities
improves predictability for industry stakeholders
Public consultation/call for evidence
Stakeholder involvement/observer status
Dissemination of scientific data and outcomes
Independence
High
Transparency
High
Main risks and opportunities:
The high impact on the ECHA committee structure needs to
be addressed and the existing expertise in the SCCS committee should be retained to the extent
possible. There is a need to ensure continuity of the opinion making to ensure undisturbed
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implementation of the Cosmetic Products Regulation. Working methodologies would need to
be adapted.
Projected impact on ECHA:
•
ECHA Committees/bodies:
high impact.
The task generates major impact on the setup
/ organisation / staffing of Committees/bodies due to the additional workload and due
to a new committee
SCCS
# of opinions per year
Opinions
Notes of guidance
11
1
rapporteur
SCCS member
SCCS member
Type of opinion
•
•
ECHA data model and IT infrastructure:
low impact.
The task can be implemented
with adjustments / configuration of existing data structures and IT systems
ECHA key experts:
high impact.
The task heavily relies on expert competencies, which
are limited within ECHA and also critical to REACH/CLP/BPR regulatory tasks
Projected workload and resource implications:
Current workload and resource use:
SCCS delivers on average 11 final opinions per year (see table below), while it has a maximum
of 20 opinions in the pipeline at any given moment based on its current composition and
structure. The SCCS is used mainly to support the Cosmetic Products Regulation but has
provided scientific advice for other sectors in the past, albeit rarely.
Number of SCCS opinions
2016
Number of
opinions
7
2017
9
2018
13
2019
12
2020
6
2021
19
DG GROW staff has one policy officer (1 FTE) dedicated to the work of the SCCS in relation
to the implementation of the CPR. The proposed reorganisation will not change the need for
the FTEs from the side of DG as it is not involved in the safety assessment as such.
The secretariat of the scientific committees hosted by DG SANTE employs 4 FTE of DG
SANTE and 2 additional FTEs of external interim staff (for technical and administrative
support like literature search, editing and proofreading of opinions, website mastering,
assistance for the Health-EU newsletter, dissemination activities). The staff of 6 FTEs is
equally split over two committees (i.e., SCCS and SCHEER), which means that 3 FTEs are
used to support work of SCCS. The SCCS is structured into 3 working groups that deal with
several opinions at the same time (sometimes up to 20). Usually, each SCCS member is a
rapporteur for 1 opinion at a time, however, quite often and in view of their expertise some
members are rapporteurs for multiple opinions in parallel. External experts sometimes can also
be nominated as rapporteurs.
The operational costs for SCCS and SCHEER (that includes special indemnities,
accommodation, daily allowances, travel costs, reimbursement for rapporteurship, etc)
operated by the Commission were EUR 2 883 030 for 6 years (2016-2021), which makes it
approximately EUR 240 000 per year per committee. It must be noted that the operational costs
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varies per year. For example, in 2019 the operational costs were EUR 370 000, which then
went down because of pandemic measures.
The resource use can be summarized as follow:
DG SANTE secretariat
SCCS committee
3 FTEs (2 internal + 1 external)
100% of membership capacity (14 members + 4 external experts)
Yearly operational budget for members of the committee was on 6 year average
(2016-2021) EUR 240 000 per year
Total
Ca. 3 FTEs
(to convert the cost of consultants into FTEs, the cost of 1 FTE consultant is estimated at ca.
EUR 66 000 annually)
Such Commission resources do not include contributions to the administrative overhead of
the Commission (HR, Finance, IT tools, etc.).
Current budget line: DG SANTE + DG GROW
Future workload and resource needs:
Because of the planned introduction of new risk management measures to cover substances
classified as endocrine disruptors, and the process for examining the safety of substances that
could affect the respiratory system and chemicals toxic to a specific target organ toxicant
(STOT), it is expected that the number of exemption requests might grow significantly and that
there will be a need for more than the current average of 11 opinions per year, with more than
up to 20 opinions in the pipeline at any given moment. However, in view of the maximum
capacity of the SCCS based on its current composition the overall number of assessments per
year may not change dramatically.
If the current ECHA estimation of resources is applied to the complexity of dossier reviewed
by the SCCS, we can extrapolate the following future allocation of FTEs: 0.35 FTE for low
complexity dossier (4 dossiers out of 11 which would require 1.4 FTE), 0.5 FTE for average
complexity (4 dossiers out of 11 would require 2 FTE) and 0.65 FTE for complex dossier (3
dossiers out of 11 which would require 1.95 FTE). For 11 opinions per year this makes 5.4
FTEs. Overhead of 15% is required to contribution for common component of IT tool
development (data submission, processing, output), and overhead of 15 % is required to
contribution for horizontal support (governance, enablers, administrative overhead), which is
additional 1.6 FTE. In total, it makes 7 FTEs. In addition, there is a need to cover travelling,
accommodation, contingency costs related to members of the SCCS, in total some EUR 300
000/year.
Summary of resource needs for cosmetic product regulation:
Agency
ECHA
Summary of tasks
Assessment for Restriction/prohibition of
substances
Assessments for authorisation of
substances and exemption requests
Financial resource
needs:
2024:
EUR0
2025:
EUR 0
2026:
EUR 300 000
2027:
EUR 300 000
2028:
EUR 300 000
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Update of the Guidance document
Human resource
needs:
2024:
2025:
2026:
2027:
2028:
0 TAs, 0 CAs
7 TAs, 0 CAs
7 TAs, 0 CAs
7 TAs, 0 CAs
7 TAs, 0 CAs
Future budget line: DG GROW
Candidate for fees: No
33. S
CIENTIFIC
C
OMMITTEES AND THEIR SECRETARIAT
(SCCS/SCHEER)
Responsible body:
Currently: Commission (DG SANTE) providing the secretariat and operating the two
committees
(Re-)attribution planned to: chemical work of both Committees to ECHA and partly also to
EFSA and EEA; non-chemical work to the Scientific Advisory Mechanism (SAM), under DG
RTD.
Legal basis for reattribution:
Revisions, omnibus regulation + Commission Decision
Type of task:
existing
Brief task overview:
Providing secretariat for the Scientific Committee on Consumer Safety
(SCCS) and on Health, Environmental and Emerging Risks (SCHEER) and providing opinions
on variety of chemical and non-chemical related subjects.
Detailed process description:
Current process:
When preparing policy or proposals related to consumer safety, health and the environment,
the Commission relies on two independent Scientific Committees to provide it with sound
scientific advice and draw its attention to new and emerging problems.
For this purpose, the Commission Decision C(2015)5383
[1]
established the following scientific
committees:
•
Scientific Committee on Consumer Safety (SCCS), and
•
Scientific Committee on Health, Environmental and Emerging Risks (SCHEER).
Formal mandate
The
SCCS
on request of Commission services shall provide opinions on questions concerning
health and safety risks, notably chemical, biological, mechanical and other physical risks, of:
1. non-food consumer products such as
-
cosmetic products and their ingredients, including nanomaterials, hair dyes,
fragrance ingredients, UV filters, preservatives, colorants, etc.;
-
personal care and household products such as detergents; toys, textiles, clothing,
etc.
2. services such as tattooing, artificial sun tanning, etc.
The
SCHEER
on request of Commission services shall provide opinions on questions
concerning health, environmental and emerging risks.
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1. In particular, the Committee shall provide opinions on questions concerning emerging
or newly identified health and environmental risks and on broad, complex or
multidisciplinary issues requiring a comprehensive assessment of risks to consumer
safety or public health and related issues not covered by other Union risk assessment
bodies. Examples of areas of activity include potential risks associated with
antimicrobial resistance, new technologies such as nanotechnologies, medical devices
including those incorporating substances of animal and/or human origin, tissue
engineering, blood products, fertility reduction, physical hazards such as noise and
electromagnetic fields, interaction of risk factors, synergic effects, cumulative effects,
and methodologies for assessing new risks. It may also be invited to address risks
related to public health determinants and nontransmissible diseases.
2. The SCHEER Committee shall also provide opinions on risks related to pollutants in
the environmental media and other biological and physical factors or changing physical
conditions which may have a negative impact on health and the environment, for
example in relation to air quality, waters, waste and soils, as well as on life cycle
environmental assessment.
3. Without prejudice to the competences conferred on the European Chemical Agency
(ECHA) and other Union bodies undertaking risk assessment, it may also be invited to
address questions relating to examination of the toxicity and eco-toxicity of chemical,
biochemical and biological compounds whose use may have adverse effects for human
health and the environment, including biocides.
4. In addition, the Committee will address questions relating to methodological aspect of
the assessment of health and environmental risks of chemicals, including mixtures of
chemicals, as necessary for providing sound and consistent advice in its own areas of
competence as well as in order to contribute to the relevant issues in close cooperation
with other European agencies.
Work of Committees in practice
The
SCCS
concentrates mostly on the risk assessment of cosmetic ingredients. Opinions
delivered by SCCS
[2]
from 2013 till today were exclusively on the safety of chemicals in
cosmetics (nanomaterials, fragrances, hair dyes, preservatives, UV filters) or methodologies
used for risk assessment of chemicals.
The
SCHEER’s
work covers rather large and diverse areas. Opinions delivered by SCHEER
between 2014 and today (see table below) were related to areas of environmental risk
assessment, medical devices, use of animals in laboratory testing, physical risks, public health
(mainly tobacco), toys and rapid risk assessment.
Table: List of delivered opinions by SCHEER since 2014, with those not about safety
assessment of chemicals highlighted in green:
Environmental risk assessment
Opinion on Draft Environmental Quality Standards for priority substances
Framework Directive – 5-6 rings polyaromatic hydrocarbons (PAH)
Opinion on Draft Environmental Quality Standards for priority substances
Framework Directive – Tributyltin compounds
Opinion on Draft Environmental Quality Standards for priority substances
Framework Directive – Dicofol
Opinion on Draft Environmental Quality Standards for priority substances
Framework Directive – PBDEs
under the Water
under the Water
under the Water
under the Water
March 2023
March 2023
January 2023
January 2023
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Opinion on Draft Environmental Quality Standards for priority substances under the Water
Framework Directive – dioxins, furans and dioxin-like PCBs
Opinion on Draft Environmental Quality Standards for priority substances under the Water
Framework Directive – HBCD
Opinion on Draft Environmental Quality Standards for priority substances under the Water
Framework Directive – Triclosan
Opinion on Draft Environmental Quality Standards for priority substances under the Water
Framework Directive – Mercury and its compounds
Opinion on Draft Environmental Quality Standards for priority substances under the Water
Framework Directive – Heptachlor including heptachlor epoxide
Opinion on Draft Environmental Quality Standards for priority substances under the Water
Framework Directive – Nickel and its compounds
Opinion on Draft Environmental Quality Standards for priority substances under the Water
Framework Directive – Glyphosate
Opinion on Draft Environmental Quality Standards for priority substances under the Water
Framework Directive – Hexachlorobutadiene
Opinion on Draft Environmental Quality Standards for priority substances under the Water
Framework Directive – Ibuprofen
Opinion on Draft Environmental Quality Standards for priority substances under the Water
Framework Directive – Fluoranthene
Opinion on Draft Environmental Quality Standards for priority substances under the Water
Framework Directive – Nonylphenol
Opinion on Draft Environmental Quality Standards for priority substances under the Water
Framework Directive – Diuron
Opinion on Draft Environmental Quality Standards for priority substances under the Water
Framework Directive – Bisphenol A
Opinion on Draft Environmental Quality Standards for priority substances under the Water
Framework Directive – Hexachlorobenzene
Opinion on Draft Environmental Quality Standards for priority substances under the Water
Framework Directive – PFAS
Opinion on Draft Environmental Quality Standards for priority substances under the Water
Framework Directive – Cypermethrin
Opinion on Draft Environmental Quality Standards for priority substances under the Water
Framework Directive – Diclofenac
Scientific Opinion on Groundwater quality standards for proposed additional pollutants in the
annexes to the Groundwater Directive (2006/118/EC)
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the
Water Framework Directive" - Chlorpyrifos
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the
Water Framework Directive" - Carbamazepine
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the
Water Framework Directive" - Bifenthrin
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the
Water Framework Directive" - Azithromycin
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the
Water Framework Directive" - Clarithromycin
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the
Water Framework Directive" - Esfenvalerate
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the
Water Framework Directive" - Permethrin
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the
Water Framework Directive" - Deltamethrin
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the
Water Framework Directive" - Thiamethoxam
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the
Water Framework Directive" - Thiacloprid
January 2023
January 2023
January 2023
December 2022
December 2022
December 2022
December 2022
December 2022
December 2022
November 2022
November 2022
October 2022
October 2022
October 2022
August 2022
August 2022
August 2022
July 2022
June 2022
May 2022
May 2022
May 2022
May 2022
March 2022
March 2022
March 2022
March 2022
March 2022
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Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the
Water Framework Directive" - Clothianidin
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the
Water Framework Directive" - Acetamiprid
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the
Water Framework Directive" - 17-Alpha-Ethinylestradiol (EE2), Beta-Estradiol (E2) and
Estrone (E1
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the
Water Framework Directive" - Erythromycin
Statement II on emerging health and environmental issues (2022)
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the
Water Framework Directive" - Nicosulfuron
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the
Water Framework Directive" - Silver and its compounds
Scientific Opinion on "Draft Environmental Quality Standards for Priority Substances under the
Water Framework Directive" - Imidacloprid
Potential for anaerobic biodegradability in marine and freshwater of Linear Alkylbenzene
Sulphonates (LAS)
Scientific advice on Guidance Document n°27: Technical Guidance for Deriving
Environmental Quality Standards
Scientific advice on Proposed EU minimum quality requirements for water reuse in agricultural
irrigation and aquifer recharge
Potential risks to human health and the environment from the use of calcium cyanamide as
fertiliser
New conclusions regarding future trends of cadmium accumulation in EU arable soils
Opinion on Synthetic Biology I, II and III - Risks to the environment and biodiversity related
to synthetic biology and research priorities in the field of synthetic biology
Opinion on Environmental risks and indirect health effects of mercury from dental amalgam
(update 2014)
Medical Devices
Opinion on the safety of breast implants in relation to anaplastic large cell lymphoma
Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical
devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR)
or have endocrine-disrupting (ED) properties
Scientific Advice on Evaluation of the availability of new scientific information on the safety
of Poly Implant Prothèse (PIP) breast implants
Scientific advice on the state of scientific knowledge regarding a possible connection between
breast implants and anaplastic large cell lymphoma
Opinion on the safety of medical devices containing DEHP-plasticized PVC or other plasticizers
on neonates and other groups possibly at risk
Opinion on the safety of surgical meshes used in urogynaecological surgery
Opinion on the safety of dental amalgam and alternative dental restoration materials for patients
and users
Opinion on the safety of the use of bisphenol A in medical devices
Opinion on the safety of Metal-on-Metal joint replacements with a particular focus on hip
implants
Opinion on the safety of Poly Implant Prothèse (PIP) Silicone Breast Implants
Non animal testing
Opinion on the need for non-human primates in biomedical research, production and testing of
products and devices (update 2017)
Physical risks
Opinion on the potential risks to human health of Light Emitting Diodes (LEDs)
Opinion on Biological effects of UV-C radiation relevant to health with particular reference to
UV-C lamps
Opinion on Biological effects of ultraviolet radiation relevant to health with particular reference
to sunbeds for cosmetic purposes
March 2022
March 2022
March 2022
February 2022
January 2022
October 2021
October 2021
October 2021
June 2020
Sept 2017
June 2017
March 2016
Nov 2015
Sept 2014; May
2015; Nov 2015
March 2014
March 2021
June 2019
Sept 2017
Oct 2017
Feb 2016
Dec 2015
Apr 2015
Feb 2015
Sept 2014
May 2014
May 2017
June 2018
Feb 2017
Nov 2016
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Final opinion on potential health effects of exposure to electromagnetic fields (EMF)
Public health
Opinion on Electronic cigarettes
Opinion on the public health impacts and risks resulting from onshore oil and gas exploration
and exploitation in the EU
Final Opinion on Additives used in tobacco products (Tobacco Additives II)
Rapid risk assessment
Guidance on
ad hoc
rapid risk assessment of serious cross-border chemical health threats
performed by the SCHEER
Toys
Final Opinion on Toxicological reference values for certain organic chemicals emitted from
squishy toys with regard to adopting limit values under the Toy Safety Directive 2009/48/EC
‘Chemicals in squishy toys’
Final Opinion on Tolerable intake of aluminium with regards to adapting the migration limits
for aluminium in toys
Opinion on Estimates of the amount of toy materials ingested by children
Opinion on Chromium VI in toys
Statements
Statement I and II on emerging health and environmental issues (2018; 2022)
SCHEER Statement on emerging health and environmental issues (2018)
SCHEER Position Paper on Emerging Issues and the Role of the SCHEER (2018)
Memorandum on weight of evidence and uncertainties - Revision 2018
Position Statement on emerging and newly identified health risks be drawn to the attention of
the European Commission
Nanotechnologies
Final opinion on Guidance on the Determination of Potential Health Effects of Nanomaterials
Used in Medical Devices
Final opinion on Nanosilver: safety, health and environmental effects and role in antimicrobial
resistance
Jan 2015
April 2021
Nov 2018
Dec 2016
Feb 2017
June 2021
Sept 2017
April 2016
Jan 2015
Jan 2022
December 2018
June 2018
June 2018
November 2014
Jan 2015
June 2014
The Rules of Procedure of the Committees are fully described here:
https://ec.europa.eu/health/sites/health/files/scientific_committees/docs/rules_procedure_201
6_en.pdf
.
In order to ensure the effective functioning of the Scientific Committees, these Rules of
Procedure regulate the functioning of the Scientific Committees, their working groups, the role
and responsibilities of members and experts, other activities related to the functioning of the
Scientific Committees, as well as the role and responsibilities of their secretariat.
The members of the SCCS and SCHEER are independent experts in various fields, selected
after a public Call for Experts and appointed for a five-year term (current one until the end of
2026).
Changes in the process:
The
SCCS
is embedded in the Cosmetics regulation as a risk assessment body providing
opinions to ensure safety of cosmetics products. In practice, SCCS serves exclusively to the
implementation of the Cosmetic Products Regulation. The impact assessment accompanying
the Commission Proposal for the revision of the Cosmetic Products Regulation contains
analysis of options for reattribution of SCCS’s tasks to ECHA. After the reattribution of work
for cosmetics regulation to ECHA, there will be no need for DG SANTE operating the SCCS.
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The
SCHEER‘s
work is diverse. One part of the SCHEER’s work relates to chemicals, namely
under the Water Framework Directive/Environmental Quality Standard Directive, Toys
Directive, Medical Devices Directive, Cross-Border Health Threats Regulation and Tobacco
Directive. This can be re-attributed to the EU Agencies.
Other part of work of the SCHEER covers diverse issues like electromagnetic fields, emerging
issues in health and environment, medical devices (like hip or breast implants), safety of LED
lights, UVC lamps and sunbeds, use of animals in laboratories, etc. This clearly does not fall
under the area of chemicals and it does not really fit to any of the EU Agencies. Such work will
be transferred to Scientific Advisory Mechanism – SAM, under DG RTD.
The SAM consists of the Group of Chief Scientific Advisors (in total seven), the Science
Advice for Policy by European Academics (SAPEA) consortium and the SAM secretariat. The
SAM functions differently than the SCHEER. The basic difference is that the SCHEER directly
gets mandates from the mandating Directorates General, i.e. policy Unit dealing with
legislative proposals. SAM gives scientific advice to the College and Commissioners on
broader issues through a request to the Commissioner for Research, Science and Innovation.
The full SAM procedure is as follows:
1. The request for advice is initiated by members of the Commission through a request to
the Commissioner for Research, Science and Innovation.
2. The Commissioner for Research, Science and Innovation is responsible for formulation
of the request. The SAM secretariat in cooperation with the requesting service prepares
a scoping paper. The Cabinet of the Commissioner for Research, Innovation and
Science consults the relevant Cabinets of the Members of the Commission on the final
draft scoping paper. If agreed, the Advisors are notified by the SAM Secretariat. The
final decision to adopt a scoping paper lies with the Commissioner for Research,
Science and Innovation in cooperation with the Advisors.
3. Once the scoping paper with the related deadline has been adopted, the advisors appoint
a lead member who asks SAM secretariat to request SAPEA to gather the evidence.
SAPE collects and review the evidence and produces Evidence Review Reports (ERR).
Expert workshops which are part of the evidence review process are by default
organised by SAPEA.
4. In view of the evidence, the lead member/coordination group will draft the Advisors’
advice, also explaining existing uncertainties as well as minority views in science, if
considered relevant. The SAM Secretariat will assist the preparation, proof-reading,
editing and formatting of the advice.
5. The Advisors will aim for adoption by consensus of its advice. A dissenting opinion by
any member(s) of the Group of Chief Scientific Advisors will be noted. Once adopted,
the Chair of the Advisors will send the advice to the Commissioner for Research,
Science and Innovation who will transmit it to the other Members of the Commission,
including to the President. The Director-General for Research and Innovation will
inform the relevant services.
The way of working might differ, but the non-chemical topics of the SCHEER could fit well
under the remit of the SAM, although targeted for a specific piece of legislation:
•
•
•
Potential risks to human health of Light Emitting Diodes (LEDs)
Biological effects of UV-C radiation relevant to health with particular reference to UV-
C lamps
Biological effects of ultraviolet radiation relevant to health with particular reference to
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•
•
•
•
•
•
sunbeds for cosmetic purposes
Electronic cigarettes/tobacco additives
Potential health effects of exposure to electromagnetic fields (EMF)
Position Statement on emerging and newly identified health risks to be drawn to the
attention of the European Commission
Estimates of the amount of toy materials ingested by children
Use of animals in laboratory testing
Synthetic biology
Proximity to Agencies’ mandate:
For chemical work, see the proximity analysis under the Cosmetic Products Regulation, the
Water Framework Directive/Environmental Quality Standard Directive/Ground water
directive, Toys Directive, Medical Devices Directive, Cross-Border Health Threats Regulation
and Tobacco Directive.
For non-chemical work, Scientific Advice Mechanism (SAM) of the DG RTD could be the
best solution as they already provide scientific advice to the College. The SAM will undergo a
reorganization along with the revamping of the scientific advice of the new Commission (2024-
2029) with help of SG.
Projected impact on Agencies:
For chemical work, see the analysis of projected impact on Agencies under the Cosmetic
Products Regulation, the Water Framework Directive/Environmental Quality Standard
Directive/Ground water directive, Toys Directive, Medical Devices Directive, Cross-Border
Health Threats Regulation and Tobacco Directive.
For non-chemical work, the projected impact on SAM is:
•
SAM Committee/bodies:
high impact.
The task generates major impact on the setup /
organisation / staffing of Committees/bodies due to the additional workload
SAM
# of opinions per
year
Opinions on non-
chemical topics of
SCHEER
•
•
1
rapporteur
SAM
Secretariat
Type of opinion
SAM data model and IT infrastructure:
low impact.
The task can be implemented
with adjustments / configuration of existing data structures and IT systems
SAM key experts:
low impact.
The task can be accommodated with existing expertise
in SAM
Workload and resource implications:
Current workload and resource use:
In the past, the Secretariat was part of a whole Unit in DG SANTE Brussels and had up to 20
FTEs. After the Secretariat of the Committees moved from Brussels to Luxembourg, the
number of staff working for both Scientific Committees started to decline every year. Until
October 2022, the Secretariat of both SCCS and SCHEER had worked with its minimum
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capacity: 3 ADs officials, 1 CA and 2 external person/contractor. As of October 2022, in
anticipation of the reattribution of tasks, the secretariat was reduced further, to 2 ADs officials
and �½ CA. The current Secretariat estimates that minimum number would be 3 FTE per
Committee (2 AD level and one secretary plus one external (contractor)). Maximum production
capacity for both Committees together is production of up to 25 Opinions per year.
Key figures of the Scientific Committees’ activity in term 2016-2021 are:
SCs
SCCS
SCHEER
ICCG
Total
No. of adopted final documents
66
29
0
95
No. of meeting days*
234
268
5.5
507.5
Number of opinions per Committee per year in term 2016-2021 are:
YEAR
4-12/2016
2017
2018
2019
2020
2021
TOTAL
SCCS
7*
9
13
12
6
19
66
SCHEER
2
9
6
3
1
8
29
The total budget spent for all the activities was
EUR 3 964 190,89
for term April 2016 to
December 2021:
•
•
EUR 2 883 030,89
were spent for meeting costs - reimbursements of Chairs and
Rapporteurs, special allowance, etc…
EUR 1 081 160,00
were spent for technical assistance (literature search, editing of
opinions, website mastering and dissemination activities).
More details can be found in their Activity Report: see activity_report_sc_20132016_en.pdf
(europa.eu)
Current budget line:
For both Committees, as of 2021, the funding comes from the EU budget (EU4Health). In the
past it was via Consumer (DG JUST) - mainly for the SCCS - and via Health (SANTE)
Programmes.
Future workload and resource needs:
For chemical work, the future workload and resource needs are estimated under the Cosmetics
Product Regulation, the Water Framework Directive/Environmental Quality Standard
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Directive/Ground water directive, Toys Directive, Medical Devices Directive, Cross-Border
Health Threats Regulation and Tobacco Directive for their respective parts.
For non-chemical work, the experience over the last 10 years shows that the number of opinions
on non-chemical issues is low and amounts to approximately 1 opinion per year. Majority of
opinions on non-chemical topics are
ad-hoc.
There are few examples of opinions that are
recurrent, like the once on electromagnetic fields (EMF) and on the use of animals in laboratory
testing (one opinion approximately every 5 years). Currently the SAM delivers around 3-4
opinions per year. The additional 1 opinion will therefore represent a significant impact. It is
estimated that addition 1 FTE for SAM secretariat will be necessary.
Summary of resource needs for non-chemical topics of SCHEER:
Agency
SAM Secretariat
(DG RTD)
Summary of tasks
Opinions on non-chemical topics
of SCHEER
Financial resource
needs:
2024:
EUR 0
2025:
EUR 0
2026:
EUR 0
2027:
EUR 0
2028:
EUR 0
2024:
0 TAs, 0 CAs
2025:
1 TAs, 0 CAs
2026:
1 TAs, 0 CAs
2027:
1 TAs, 0 CAs
2028:
1 TAs, 0 CAs
Human resource
needs:
Future budget line: DG RTD
Candidate for fees: No
34. E
CODESIGN FOR
S
USTAINABLE
P
RODUCTS
R
EGULATION
Responsible body:
Currently: N/A, no current process
Reattribution planned to: TBC
Legal basis for reattribution:
proposal for Ecodesign for Sustainable Products Regulation.
Type of task:
new
Brief task overview:
The draft regulation sets a framework provisions and the details of
implementation (such as scope, IT formats, etc.) will be set at the later stage via the delegated
or implementing acts. The framework provisions do not set any direct obligations on the
Agencies. However, it is expected that as part of the delegated acts Agencies will be required
to support several technical tasks and operate IT systems. The topic of interest from the
chemical perspective is the digital product passport, where ECHA may be expected to provide
information on the presence of substances of concern in products (link with the existing SCIP
database, but expectations would be broader than the current scope of SCIP). ECHA may be
expected to build a bridge between SCIP and the product passports, but the details of the work
are not known yet.
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The draft Regulation also includes a provision for the Commission to request ad-hoc advice
from the Agencies when assessing the self-regulation measures; it is yet unclear whether and
which Agencies’ expertise would be required as part of this process and the related workload.
Proximity to Agencies mandate:
ECHA’s core mandate is related to the safety assessment of
chemicals. The provision of information on the presence of SoC in products could be seen as
an extension of the mandate from chemicals to products and from risk assessment to providing
information.
Main risks and opportunities:
Risk of deviating from ECHA core mandate of safety
assessment of chemicals. The scope of information on chemicals in the Digital Product
Passports (DPP) is expected not to be the same as in SCIP: Product passport are to report on
all substances of concern, while SCIP only reports on the presence of Candidate List substances
(SVHCs), which is at least a 100-fold increase in scope. Currently, with ca. 200 SVHCs in
scope ECHA has received already 21 million SCIP notifications. If the scope is 100-fold
bigger, the number of notifications may become excessive. If the product passport is to be a
system among the companies, it remains to be seen how ECHA can contribute to such system
and what role it would play.
Projected impact on ECHA
•
•
•
ECHA Committees/bodies:
no impact.
The task does not require involvement of
ECHA Committees/bodies
ECHA data model and IT infrastructure:
high impact.
The task requires investment in
entirely new data structures and IT systems/capabilities
ECHA key experts:
high impact.
The task heavily relies on expert competencies,
which are limited within ECHA and also critical to REACH/CLP/BPR regulatory
tasks
Projected workload and resource implications
Current workload and resource use:
Not yet analysed, as the obligations are not yet clear. This will be done as part of the delegated
acts once the main act is adopted.
Future workload and resource needs
Not yet analysed, as the obligations are not yet clear
35. T
OBACCO PRODUCTS DIRECTIVE
Responsible body:
Currently: Commission with the support of the SCHEER Committee
Reattribution planned to: TBC
Legal basis for reattribution:
revision of the Tobacco directive (2014/40/EU)
Type of task:
new
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Brief task overview:
The tobacco directive is undergoing an evaluation and a revision of the
directive is being envisaged. As part of the revision, a new scientific and technical work is
being envisaged that could be potentially attributed to EU Agencies. Currently, Under Article
6(1), the Commission adopted a decision, establishing a priority list of 15 additives for which
enhanced reporting obligations are in place, selected on the basis of a SCHEER scientific
opinion. It is being considered whether in future in addition, a positive list of ingredients and a
database would need to be established. In addition, the work may include:
•
•
•
•
•
•
•
Managing the laboratory network on tobacco control;
Checking compliance with product presentation provisions;
Running the procedure determining characterizing flavour;
Updating negative/positive lists of additives;
Hosting product database and making publicly available the product information;
Monitoring of data in product notifications;
Assessing information on leaflets.
Proximity to Agencies’ mandate:
The tasks are not yet clear but those that are being
considered do not naturally fit to the agencies considered in this initiative.
Main risks and opportunities:
ECHA’s, EFSA’s and EMA’s core mandate relates to the
safety assessment of chemicals to protect human health and the environment. The proposed
tasks are not related to that core mandate.
Projected workload and resource implications
Future workload and resource needs:
Not yet analysed, as the obligations are not yet clear.
36. R
EGULATION
ON FLUORINATED GREENHOUSE GASES AND
DEPLETING SUBSTANCES
R
EGULATION
ON OZONE
Responsible body:
Currently: Commission and EEA
Reattribution planned to: TBD
Legal basis for reattribution:
revision of regulation on fluorinated greenhouse gases
(517/2014) and revision of regulation on ozone depleting substances (1005/2009)
Type of task:
new
Detailed task overview:
Current:
The Commission is implementing a quota and licencing system for hydrofluorocarbons as well
as a similar system for ozone depleting substances (ODS) that both require registration of
importers and producers of these chemicals, determination and allocation of company quota
and issuing of penalties for non-compliance with the quota system. Annual company reporting
data is collected and aggregated by the European Environment Agency each year. The agency
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prepares a report on ODS and F-gas related activities for Member State representatives and the
Commission (DG CLIMA), which includes for instance for F-gases data on imports, exports,
production, destruction, and reclamation relevant to bulk F-gases and equipment containing
such gases
Changes:
On 5 April 2022, the Commission presented a proposal for a regulation on fluorinated
greenhouse gases (F-gases) that would repeal Regulation (EU) No 517/2014 and a proposal
repealing Regulation on ozone depleting substance (EC) No 1005/2009. The proposal aims to
further reduce emissions of these chemicals. The F-gas proposal would change the existing
quota system, gradually reducing the supply of hydrofluorocarbons (HFC) to the EU market to
approximatively 2.4 % of 2015 levels by 2048 and requiring a quota allocation price which
needs to be collected. The quota revenue can partly be used for the implementation of the quota
and licensing system. For ozone depleting substances the quota system will be abolished and
the licencing system simplified. Both licensing systems and labelling obligations will be
strengthened to improve enforcement of trade and hydrofluorocarbon (HFC) quota restrictions.
Finally, the proposals would align EU legislation with the requirements of the Montreal
Protocol.
The European Environmental Agency (EEA) will have to slightly adapt their reporting tool for
undertakings reporting on F-gases and ozone depleting substances, due to changes in the
reporting requirements.
The proposal retains the obligation on the Commission to set up and operate an electronic
system for the management of the quota system for HFCs as well as the licensing of imports
and exports and reporting for F-gases and for ozone depleting substances. It is not yet clear
how the tasks can be implemented most effectively, but it is envisaged that an agency could
take some of the tasks in case that would be deemed to be the best option at a later stage.
Proximity to Agencies’ mandate:
The Regulations are still under review and tasks related to
setting-up and operating of the electronic system are not yet fully clear. It thus remains unclear
if any of the agencies would be suitable for such tasks.
Projected workload and resource implications
Future workload and resource needs
Not yet analysed, as the tasks are not yet defined
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