Europaudvalget 2018
KOM (2018) 0697
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EUROPEAN
COMMISSION
Brussels, 17.10.2018
SWD(2018) 438 final
COMMISSION STAFF WORKING DOCUMENT
Synthesis Report on the Operation of Regulation (EU) No 649/2012 concerning the
export and import of hazardous chemicals
Accompanying the document
Report from the Commission to the European Parliament, the Council, the European
Economic and Social Committee and the Committee of the Regions
Summary of the Synthesis Report on the operation of Regulation (EU) No 649/2012
concerning the export and import of hazardous chemicals
{COM(2018) 697 final}
EN
EN
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Contents
1
INTRODUCTION..................................................................................................... 5
1.1
1.2
1.3
The PIC Regulation ....................................................................................... 5
The reporting exercise .................................................................................. 6
Methodology ................................................................................................ 6
1.3.1
1.3.2
1.3.3
1.3.4
2
Preparation of the Commission’s report
.............................................. 6
Implementation of the common format for reporting for Member
States in the form of a web-based questionnaire ................................. 7
Synthesis of Member States’ reporting
............................................... 8
Drafting the synthesis report and summary ........................................ 8
GOVERNANCE OF THE PIC REGULATION ................................................................... 9
2.1
Organisation of the implementation of the PIC Regulation ................................. 9
2.1.1
2.1.2
2.1.3
2.2
European Commission ...................................................................... 9
European Chemicals Agency (ECHA) .................................................. 9
DNAs ............................................................................................11
Coordination between the Commission, the Agency and Designated National
Authorities..................................................................................................14
2.2.1
2.2.2
2.2.3
Coordination between DNAs and the Commission ...............................14
Coordination between DNAs and the Agency ......................................14
Coordination between the Agency and the Commission .......................14
Coordination of Union input to the Conference of the Parties (CoP) .......16
Participation in committees and expert groups ...................................16
Financial contributions to the Rotterdam Convention ...........................17
2.3
The EU as a Party to the Rotterdam Convention ..............................................15
2.3.1
2.3.2
2.3.3
3
UPDATES OF ANNEX I AND ANNEX V TO THE PIC REGULATION ..................................18
3.1
3.2
Update of Annex I .......................................................................................18
Updates of Annex V .....................................................................................20
4
OPERATION OF THE PIC REGULATION .....................................................................21
4.1
Support to exporters and importers ...............................................................21
4.1.1
4.1.2
4.2
4.2.1
4.2.2
4.2.3
4.2.4
4.2.5
4.2.6
4.2.7
4.3
4.4
4.5
4.6
4.7
Support provided by DNAs ...............................................................21
Support provided by the Agency .......................................................22
Export notifications processed during the reporting period ...................25
Special RIN requests processed during the reporting period .................26
Requests for resubmission and rejection of export notifications ............27
Difficulties encountered in the export notification procedure ................29
Emergency situations (Article 8(5)) ..................................................31
Provision of available additional information on exported chemicals ......32
Administrative fee for export notifications ..........................................32
Export notifications forwarded to Parties and other countries (Article 8) .............24
Export notifications from Parties and other countries (Article 9) ........................32
Information on export and import of chemicals (Article 10)...............................33
Notification of banned or severely restricted chemicals under the Convention
(Article 11-12) ............................................................................................33
Obligations in relation to importing chemicals (Article 13) ................................34
Obligations in relation to exports of chemicals, other than export notifications
(Article 14) .................................................................................................35
4.7.1
4.7.2
Communication of information and decisions to those concerned
within the jurisdiction of a Member State (Article 14(3)) .....................35
Explicit consent (Article 14(6)) .........................................................35
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4.7.3
4.7.4
4.8
4.9
4.10
Waivers (Article 14(6) and (7)) ........................................................37
Validity of explicit consent (Article 14(8)) ..........................................38
Information on transit movement (Article 16) .................................................39
Requirements linked to exported chemicals and accompanying information
(Article 17) .................................................................................................39
Enforcement of Regulation (EU) No 649/2012 (Article 18) ................................40
4.10.1
4.10.2
4.10.3
4.10.4
4.10.5
4.10.6
4.10.7
4.10.8
National enforcement authorities (NEAs) ...........................................40
Training inspectors .........................................................................41
Enforcement strategy......................................................................41
Enforcement activities .....................................................................42
Enforcement actions and penalty systems .........................................44
Infringements during the reporting period .........................................44
Collaboration between DNAs and NEAs ..............................................46
Forum activities .............................................................................47
4.11
4.12
4.13
Exchange of information (Article 20) ..............................................................48
Technical assistance (Article 21)....................................................................49
IT-related aspects .......................................................................................50
4.13.1
4.13.2
4.13.3
4.13.4
The ePIC system ............................................................................51
User-friendliness of the ePIC system .................................................52
Areas of improvement .....................................................................54
Data dissemination .........................................................................54
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Abbreviations used
BPR
CLP
CN
CoP
CRC
CUS
DNA
DNA
ECHA
ePIC
EU
FRA
NEA
OECD
PIC
POPs
PPPR
RC
REACH
RIN
SAICM
SDS
Biocidal Products Regulation
Classification, Labelling and Packaging Regulation
Combined Nomenclature
Conference of the Parties to the Rotterdam Convention
Chemical Review Committee of the Rotterdam Convention
Customs Union and Statistics
Designated National Authority
Designated National Authority
European Chemicals Agency
Software application for implementation of Regulation (EU) No 649/2012
European Union
Final Regulatory Action
National Enforcement Authority
Organisation for Economic Cooperation and Development
Prior Informed Consent
Persistent Organic Pollutants
Plant Protection Products Regulation
Rotterdam Convention
Registration, Evaluation, Authorisation and Restriction of Chemicals
Regulation
Reference Identification Number
Strategic Approach to International Chemicals Management
Safety Data Sheet
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1 I
NTRODUCTION
1.1 The PIC Regulation
Regulation (EU) No 649/2012
1
(‘the PIC Regulation’)
implements the Rotterdam
Convention on the Prior Informed Consent (PIC) Procedure for Certain Hazardous
Chemicals and Pesticides in International Trade, adopted in 1998 and ratified by the EU
in 2002. The Regulation aims to promote shared responsibility and cooperation in the
international movement of hazardous chemicals, and to protect human health and the
environment from potential harm by facilitating the exchange of information concerning
the characteristics of hazardous chemicals, providing for a decision-making process
within the EU on the import and export of such chemicals, and disseminating decisions
to Parties to the Convention and other countries (Article 1).
The PIC Regulation applies to chemicals subject to the PIC procedure under the
Rotterdam Convention, as well as to industrial chemicals (used by professionals and
consumers) and pesticides (including biocides) that are banned or severely restricted by
EU legislation for health or environmental reasons. The Regulation places obligations on
companies intending to export such chemicals to third countries, whether or not they
are Parties to the Rotterdam Convention. Exports are subject to different requirements
depending on their listing in Annex I to the Regulation: chemicals listed in Part 1 of
Annex I are subject to export notification to the authority of the importing country;
chemicals listed in Parts 2 and 3 of Annex I are subject to export notification and explicit
consent of the authority of the importing country, unless they are subject to the PIC
procedure under the Convention and exported to a Party that has provided a positive
import response, or to a country that has waived its right to be notified. These
obligations also apply to mixtures containing substances listed in Annex I to the
Regulation in concentrations that trigger labelling obligations under the Classification,
Labelling and Packaging Regulation (EC) No 1272/2008
2
(CLP Regulation), and to
articles containing substances listed in Parts 2 or 3 of Annex I in unreacted form, or
mixtures containing substances listed in Parts 2 or 3 of Annex I in concentrations that
trigger labelling obligations under the CLP Regulation.
The PIC Regulation also places obligations on the Commission to notify the Secretariat of
the Convention of Final Regulatory Action (FRA) on chemicals that are banned or
severely restricted through FRA in the EU in one use category of the Convention
(industrial chemicals or pesticides) and which are listed in Part 2 of Annex I of the PIC
Regulation, as well as to inform other Parties about their potential risks and allow them
to consider whether or not risk management measures are needed in their own
territories. This process is known as the FRA notification and is the basis for the listing of
chemicals in Annex III to the Convention.
For chemicals that are listed in Part 3 of Annex I (which reflects Annex III to the
Convention), the Commission, in close cooperation with the Member States, decides if
the chemical can be imported in the EU and under which conditions. This is done
through an import decision, which is then sent to the Secretariat of the Convention.
1
Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the
export and import of hazardous chemicals, OJ L 201, 27.7.2012, pp. 60–106.
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on
classification, labelling and packaging of substances and mixtures, amending and repealing Directives
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, OJ L 353, 31.12.2008, pp. 1–
1355.
2
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1.2 The reporting exercise
Article 22 of the PIC Regulation requires the Commission to report on its activities under
the Regulation every three years, and to compile a synthesis report on the performance
of the PIC Regulation, integrating the following:
The information submitted by Member States as per Article 22(1), concerning the
operation of the procedures provided for in this Regulation, including customs’
controls, infringements, penalties and remedial action.
The information submitted by the European Chemicals Agency (ECHA) as per
Article 22(1), concerning the operation of the PIC Regulation’s procedures.
This reporting exercise is the first under the new PIC Regulation. It covers the three
years of implementation since the Regulation became applicable (2014
3
-2016). A
common reporting format for Designated National Authorities (DNAs) was established by
Commission Implementing Decision (EU) 2016/770 of 14 April 2016
4
, in order to collect
consistent information across Member States. Similarly, a reporting format for the
Agency’s report was adopted through Commission Implementing Decision (EU)
2016/1115 of 7 July 2016
5
.
Although the Member States and the Agency were required to report by 31 May 2017,
the reporting process encountered some delays. The report from the Agency was
received on 18 July 2017, while the Member States’ reporting was completed on 5
October 2017, when the final reporting questionnaire was submitted.
The present report is the synthesis report (as per Article 22 of the PIC Regulation),
bringing together the findings from the reports of the Commission, the Agency’s, and
Member States. It provides an overview of the implementation of the PIC Regulation in
the period 2014-2016.
1.3 Methodology
1.3.1
Preparation of the Commission’s report
The report is divided into two sections, the first addressing the work of the Commission
with respect to implementation within the EU, and the second addressing the
international work of the Commission as the EU DNA to the Rotterdam Convention.
Additional relevant information was compiled from EUR-lex, the website of the
Rotterdam Convention, and documents published on CIRCABC, including minutes of
meetings, and other documents discussed at DNA meetings (see Table 1). Other
information was obtained first-hand from Commission officials. Sources used for this
report are listed in Table 1 below. The report was then used as a source for the
synthesis report.
3
4
Regulation (EU) No 649/2012 applied from 1 March 2014.
Commission Implementing Decision (EU) 2016/770 of 14 April 2016 establishing a common format for the
submission of information concerning the operation of the procedures pursuant to Regulation (EU) No
649/2012 of the European Parliament and of the Council concerning the export and import of hazardous
chemicals, C/2016/2068, OJ L 127, 18.5.2016, pp. 32–51.
Commission Implementing Decision (EU) 2016/1115 of 7 July 2016 establishing a format for the submission
by the European Chemicals Agency of information concerning the operation of the procedures pursuant to
Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and
import of hazardous chemicals, C/2016/4141, OJ L 186, 9.7.2016, pp. 13–23.
5
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Table 1: List of relevant documents consulted for the Commission report
List of relevant documents consulted
Implementing and delegated acts
Commission Delegated Regulation (EU) No 1078/2014 amending Annex I to the PIC Regulation.
Commission Delegated Regulation (EU) 2015/2229 amending Annex I to the PIC Regulation.
Commission Implementing Decision of 11 February 2016 adopting Union import decisions
(2016/C 61/06).
Commission Implementing Decision of 15 May 2014 adopting Union import decisions (2014/C
152/02).
Commission Implementing Decision of 14 April 2016 establishing a common format for the
submission of information concerning the operation of the procedures pursuant to Regulation
(EU) No 649/2012 of the European Parliament and of the Council concerning the export and
import of hazardous chemicals.
Commission Implementing Decision of 7 July 2016 establishing a format for the submission by
the European Chemicals Agency of information concerning the operation of the procedures
pursuant to Regulation (EU) No 649/2012 of the European Parliament and of the Council
concerning the export and import of hazardous chemicals.
Minutes of 23
rd
, 24
th
, 25
th
, 26
th
, 27
th
and 28
th
DNA meetings.
Amendments to Annex I to Regulation (EU) No 649/2012 presented at 23
rd
, 24
th
, 25
th
, 26
th
, 27
th
and 28
th
DNA meetings.
Import decisions presented at 23
rd
, 24
th
, and 26
th
DNA meetings.
Submission of notifications to the PIC secretariat presented at 23
rd
, 24
th
, 25
th
, 26
th
, 27
th
and 28
th
DNA meetings.
Implementation issues presented at 23
rd
, 24
th
, 25
th
, 26
th
, 27
th
and 28
th
DNA meetings.
Documents on the preparation of COP 7 and 8 presented at 25
th
, 26
th
and 28
th
DNA meetings.
PIC circulars published by the Rotterdam Convention.
DNA meeting documents
Rotterdam Convention documents
1.3.2 Implementation of the common format for reporting for
Member States in the form of a web-based questionnaire
The common reporting format was made available online to Member States on 2
February 2017, through EU Survey. A guidance document for Member States
accompanied the invitation email. The project team was also available to answer DNA
questions on EU Survey and/or the reporting format, as well as supporting the DNAs in
submitting their questionnaires.
To facilitate Member State reporting, the Agency has made data from ePIC available to
DNAs for the following questions:
Section 2 - Question 10: number of export notifications and Special RIN requests
accepted by DNA and forwarded to the Agency.
Section 5 - Question 20: number of export notifications sent back to the exporter
either to request resubmission or because the notification was rejected.
Section 7 - Question 40: number of requests for explicit consent and number of
responses received per year.
Section 7 - Question 43: number of cases where DNA had to decide if no explicit
consent was required in case of chemicals listed in Part 2 of Annex I to be
exported to OECD countries.
Section 7 - Question 45: number of waiver requests received by DNAs.
Section 7 - Question 47: number of cases where the export was allowed to
proceed pending a reply to a new request for explicit consent.
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For consistency, the data provided by the Agency were used for these questions, even
where the data provided by the Member States differed from that data sent by the
Agency.
1.3.3
Synthesis of Member States’ reporting
Once all Member States had returned their reporting questionnaires, the full dataset and
statistics were downloaded in excel format from EU Survey. The information provided by
the DNAs was compiled and summarised for each question and presented visually,
where relevant. The full set of DNA responses is available in Annex II.
1.3.4 Drafting the synthesis report and summary
The synthesis report combines the information from the Commission report, the Member
States’ reporting questionnaires and the Agency’s questionnaire.
It follows the structure
of the common Member States’ reporting questionnaire and the questionnaire for the
Agency’s reporting, integrating the information from the Commission report, where
relevant. The summary follows the same structure as that of the synthesis report,
presenting the key facts and conclusions from each section.
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2 G
OVERNANCE OF THE
PIC R
EGULATION
2.1 Organisation of the implementation of the PIC Regulation
2.1.1 European Commission
The Commission, in cooperation with the Member States, is responsible for policy work
under the PIC Regulation, in particular the adoption of amendments to Annexes I and V
to the Regulation. In addition, the Commission is responsible for the legal interpretation
of the Regulation, and representation of the Union in the Convention and towards non-
EU Parties, which includes acting as a common designated authority for the
administrative functions of the Convention with respect to the PIC procedure (see
Section 2.3). The Commission also chairs the DNA meetings that occur twice a year,
normally in April and October.
DG Environment takes charge of the PIC Regulation. Unit B.2
sustainable chemicals
has one policy coordinator responsible for implementation of the PIC Regulation,
including policy and legal matters and international cooperation and representation. The
policy coordinator is supported by a lawyer for legal questions, and by a secretary for all
organisational work. For international work, Unit B.2 has one expert (the policy
coordinator) who was nominated to the Convention bodies, i.e. the Chemical Review
Committee (CRC) and the intersessional working group on the process of listing
chemicals in Annex III to the Convention. In addition, colleagues of Unit F.3, which is
responsible for multilateral environmental cooperation, contribute to the international
work, particularly in the context of the CoP, by dealing with horizontal and cross-cutting
matters such as financial resources, budget, technical assistance and some legal
matters. The staff resources occupied by this work amount to 0.4 FTE for the policy
coordinator and 0.4 FTE for the supporting work, including international matters.
2.1.2 European Chemicals Agency (Agency)
The Agency plays a central role in ensuring that the export notification procedure
functions properly, as well as developing and operating the application to process export
notifications and the explicit consent given by the importing countries (ePIC). More
specifically, the tasks of the Agency include:
Registering the export notifications established by the exporters and sent by EU
DNAs, assigning them a Reference Identification Number (RIN), checking their
completeness and forwarding them to the DNA of the importing country (Article
8(2).
Sending a second export notification if the Agency does not receive an
acknowledgement of receipt from the authority in the non-EU country within 30
days of the first notice (Article 8(3)).
Making available to all EU DNAs export notifications received from third country
DNAs (Article 9(1)).
Acknowledging receipt of export notifications received from non-EU countries
(Article 9(1)).
Sending a reminder for an explicit consent request if no response is received
from the authorities in the non-EU country within 30 days of the initial request;
sending a second reminder after a further 30 days if a response is still
outstanding (Article 14(6)).
Managing ePIC and keeping all relevant document available on the platform;
Supporting the EU DNAs and the European Commission in assessing waivers
pursuant to Article 14(6) and 14(7).
Aggregating and summarising the data received each year from DNAs on the
quantities of exported and imported chemicals, and making non-confidential
information publicly available (Article 10(3)).
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Every two years, compiling and publishing the information transmitted by the
Commission, the Member States and the Agency to the authorities in third
countries on the chemicals subject to the Regulation.
The Agency’s Secretariat of the Forum for Exchange of Information on
Enforcement established by the REACH Regulation also provides coordination and
support to discussions related to PIC (Article 18(2)).
Participate in the twice-yearly DNA meetings organised by the Commission and
provide updates on the operations and opinions of relevant documents discussed
at these meetings.
In addition, the Agency provides assistance and technical and scientific guidance to
industry, the DNAs from Member States and third countries, and the European
Commission (Article 6).
Resources dedicated by the Agency to the operation of the PIC Regulation have
remained stable over the reporting period (see Table 2).
Table 2:
Agency’s staff working on the PIC Regulation
Number of staff working on PIC (FTE)
2014
2015
2016
7
7
7
The Agency’s staff working on PIC also collaborate with the staff working on other EU
regulations for which the Agency is responsible, i.e. REACH, CLP and the Biocidal
Products Regulation (BPR), where there are synergies with processes that run across the
various pieces of legislation. For example, the Agency’s staff collaborate on:
Development and maintenance of ePIC in order to benefit from synergies
between all the Agency’s IT tools concerning login and account management;
Support to (Article 8(2) stakeholders;
Substance identity check of substances added to the PIC Regulation;
Publication of data on the Agency’s website;
Safety Data Sheet (SDS) checks (e.g. inaccuracies in defining the concentration
of a substance, a mixture composition, doubts about classification, etc.);
Support to the Commission in drafting FRA notifications submitted to the
Rotterdam Convention Secretariat;
Support to the Commission and the Member States by the presence of a nominee
on the CRC;
Drafting guidance for the implementation of the PIC Regulation;
Legal advice;
Communications;
Human resources.
The Agency’s workload during the reporting period was higher than
predicted before the
entry into force of the Regulation. As highlighted in its report, the number of export
notifications increased beyond the predicted 10% yearly increase (see Table 3), which
led to an increase in processing tasks to be performed by the Agency and thus the time
spent on supporting DNAs (from EU and non-EU countries), which takes 30-40% of staff
time. The increase in export notifications also made additional improvements of ePIC
necessary (e.g. increasing the automation of certain processes to reduce the workload
for industry users and authorities and enable them to meet legal deadlines), and caused
more requests for support from the Agency (see Table 4).
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Table 3: No. of export notifications predicted vs. processed by the Agency
2014
No. of estimated notifications
Actual no. of notifications
4,000
4,575
2015
4,300
5,460
2016
6,300
7,967
Table 4: No. of requests for technical/regulatory support from the Agency
No. of requests
regulatory support
for
technical/
2014
1,000
2015
1,500
2016
1,800
As the distribution of work is uneven during the calendar year, peaking during the winter
months, the Agency reported regularly hiring interim staff for several months every year
to meet the increased need.
2.1.3 DNAs
Member States play a major role in the application, implementation, and enforcement of
the PIC Regulation. As per Article 4 of the PIC Regulation, Member States must
designate one or several authorities to carry out the administrative functions required by
the Regulation. A total of 35 authorities have been designated by Member States. Article
18 of the PIC Regulation also requires Member States to designate enforcement
authorities, such as customs authorities (see Section 4.10).
The responsibilities of the Member States are largely discharged by DNAs and can be
divided in four categories: administrative tasks, enforcement, monitoring and reporting,
and exchange of information
6
.
Administrative tasks
Check compliance of export notifications with Annex II and forward these to the
Agency (Article 8(2)).
Request explicit consent from the DNA/appropriate authority of the importing
country for the export of the chemicals listed in Parts 2 and 3 of Annex I. In the
case of export of Annex I Part 2 chemicals to OECD countries, decide (in
consultation with the Commission) if the requirement for explicit consent may be
waived on the basis of the chemical being licensed, registered or authorised in
the OECD country concerned (Article 14(6)).
Consult the Commission and take decisions on the granting of a waiver for the
export of chemicals listed in Parts 2 and 3 of Annex I in cases where no response
is received within 60 days of a request for explicit consent (Article 14(7)).
Assist the Commission in its periodic review of explicit consents and waivers
(Article 14(8)).
Forward export notifications received from third countries to the Agency (Article 9
(2)).
Provide the Commission with sufficient information on FRA to ban or severely
restrict a chemical at national level and consider any comments received from
other Member States (Article 11(8)).
Inform the Commission of national regulatory actions related to PIC chemicals so
that this information can be taken into account in EU import decisions (Article
13(2)) and make EU import decisions available to those concerned within their
competence (Article 13(5)).
6
Adapted from: ECHA,
Guidance for implementation of Regulation (EU) No 649/2012 concerning the export
and import of hazardous chemicals,
version 1.1, 2015.
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Forward information on chemicals subject to the PIC procedure and on decisions
of importing parties regarding import conditions applicable to those chemicals to
those concerned within its jurisdiction (Article 14(3) in conjunction with Article
14(1)).
Handle Special RIN requests.
Participate in twice-yearly DNA meetings organised by the Commission, and
provide opinions on relevant documents discussed at these meetings.
Enforcement
Ensure that exporters meet their obligations, in particular those relating to
Articles 8, 10, 14, 15 and 17.
Take measures to ensure compliance, including the establishment of penalties for
infringements (Article 28).
Participate in the activities of the Forum for Exchange of Information on
Enforcement related to the PIC Regulation (Article 18(2)).
Monitoring and reporting
Provide the Agency with annual aggregated reports on trade in chemicals listed in
Annex I (Article 10(3)).
Every three years, provide the Commission with information on the operation of
the PIC Regulation (Article 22).
Provision and exchange of information
Provide importing countries with additional information relating to exported
chemicals, on request (Article 8(7)).
Assist the Commission in compiling additional information with respect to FRA
notifications, on request (Article 11(6)).
Where requested, advise and assist importing countries to obtain additional
information to help them with an import response for PIC chemicals (Article
14(5)).
Forward to the Commission (with a copy to the Agency) any information required
by an importing Party to the Convention that has been provided by the exporter
concerned prior to each transit movement of a chemical listed in Part 3 of Annex
I (Article 16(3)).
Facilitate the exchange of information (Article 20) and cooperate in the
promotion of technical assistance (Article 21).
Most Member States (22) have only one DNA, while six have two or three (Table 5).
DNAs are mostly Ministries or agencies responsible for environment, chemicals, and
health or health and safety. In a few cases, the Ministries responsible for economy,
competition, labour or agriculture have been designated as competent authorities. In the
Netherlands, the customs authority is the only DNA.
Table 5: Distribution of responsibilities across DNAs in Member States with more than one DNA
Member States
Greece
Distribution of responsibilities
Directorate of Energy, Industrial and Chemical Products, General
Chemical State Laboratory: responsible for industrial chemicals
Department of Plant Protection Products and Biocides, Ministry of
Rural Development and Food: responsible for pesticides
Ministry of Human Capacities: responsible for industrial chemicals
National Food Chain Safety Office: responsible for pesticides
The Health and Safety Authority: DNA for industrial chemicals
The Revenue Commissioners: solely for the purposes of Article 18
of the PIC Regulation
The Minister for Agriculture, Food and the Marine: responsible for
pesticides (other than for the purposes of Article 18 of the
Rotterdam Regulation)
Hungary
Ireland
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Member States
Latvia
Distribution of responsibilities
Latvian Environment, Geology and Meteorology Centre: responsible
for industrial chemicals
State Plant Protection Service: responsible for pesticides
Ministry of Economy: responsible for industrial chemicals
Ministry of Agriculture and Rural Development: responsible for
pesticides
Health and Safety Executive: DNA for Great Britain
Health and Safety Executive Northern Ireland: DNA for Northern
Ireland
Slovakia
UK
Although the UK officially has two DNAs, through an agreement between Great Britain
and Northern Ireland, all of the UK DNA work is carried out by the Health and Safety
Executive.
In Member States with more than one DNA, responsibilities are generally divided, with
one DNA responsible for industrial chemicals while another is responsible for pesticides.
Table 5 provides information on the distribution of responsibilities among those Member
States with several DNAs.
With the exception of the Netherlands, DNAs in all other Member States are involved in
the implementation of other EU or international chemicals management instruments,
such as legislation, conventions or programmes (see Figure 1). Twenty DNAs (in 19
Member States) are also responsible for the implementation of the REACH Regulation,
21 DNAs (in 20 Member States) for CLP, 15 for the BPR and 8 for the PPPR. In eight
Member States, the DNAs are also involved in the implementation of the Stockholm
Convention.
The resources needed to implement the PIC Regulation in Member States, in particular
the human resources, largely depend on the number of export notifications and requests
for explicit consent that are processed. The figures provided by Member States for
human resources working on PIC in the DNAs vary between 0.1 FTE for those Member
States with few or no export notifications to process, and 2 FTE for those Member States
with the highest numbers of export notifications.
Figure 1: Other EU legislation for which PIC DNAs are also responsible
CLP
REACH
BPR
PPPR
Detergents Regulation
POPs Regulation
Ozone depleting substances Regulation
0
5
10
15
20
25
Number of DNAs
12
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2.2 Coordination between the Commission, the Agency and Designated
National Authorities
2.2.1 Coordination between DNAs and the Commission
All Member States considered the coordination between the DNAs and the Commission
to be satisfactory. Three Member States mentioned that the regular DNA meetings are
an important coordination mechanism, and seven indicated that the support provided by
the Commission to DNAs (especially answers to DNA questions) is quick and of good
quality.
According to the DNAs, the update of annexes (Article 23) and the obligation to monitor
exporters’ compliance (Article 18(1)) are areas that could still be improved. Several
DNAs also mentioned that relevant documents should be made available in due time
before DNA meetings.
For its part, the Commission also considered the cooperation with DNAs to be
satisfactory. There have been regular exchanges during the reporting period on
scientific, technical and legal questions arising in the context of implementation, in
particular through discussions at the twice-yearly PIC DNA meetings. The Commission
also coordinates and consults with DNAs on any submissions to the Secretariat of the
Rotterdam Convention.
2.2.2 Coordination between DNAs and the Agency
All Member States considered the coordination between the DNAs and the Agency to be
satisfactory. Eight Member States specified that the assistance provided by the Agency
to DNAs is valued for its swiftness and quality.
The main areas of improvement, according to the DNAs, are the updating of annexes
(Article 23), followed by technical assistance (Article 21), and the provision of additional
information on exported chemicals, on request (Article 8(7)).
According to the Agency, the collaboration with DNAs is also satisfactory. It indicated
that collaboration with DNAs is efficient and friendly, including when handling
disagreements. Cooperation could be improved, however, regarding the implementation
of Article 8(2) on the timelines for processing export notifications, Article 8(5) on export
in case of an emergency situation, Article 14(6) on substances that cannot be exported
unless certain conditions are fulfilled, and Article 14(6) and (7) on decisions that the
export can proceed in the absence of an explicit consent.
2.2.3 Coordination between the Agency and the Commission
The Commission considered cooperation with the Agency to be satisfactory, as there
were regular exchanges on scientific, technical and legal questions arising in the context
of implementation, in particular on the legal interpretation of provisions and their
practical implementation. The Agency participated in all DNA meetings to report on the
work done in the area of implementation. The Commission contributed to the
development of the guidance produced by the Agency, as well as to the work of the
Forum on Exchange of Information on Enforcement.
Regarding the cooperation with third countries and the Secretariat of the Rotterdam
Convention, the Commission and the Agency have closely coordinated their activities to
ensure that the most appropriate and effective assistance is provided and that resources
are used efficiently.
According to the Agency, coordination with the Commission is generally satisfactory. It
did, however, point to the following areas which could be improved:
13
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Preparation of FRA notifications to the Rotterdam Convention
Secretariat:
In some cases, tasks have been assigned with a short deadline and
without advance warning. Increased predictability and common planning would
help the Agency to ensure timely development of good quality notifications.
Technical preparation of meetings:
the Agency mentioned that documents
are often sent by the Commission for checking/drafting with very short deadlines,
making it difficult for the Agency to produce high-quality documents. Preparation
for the meetings could be improved by greater collaboration between the Agency
and the Commission/ Member State experts.
Article 14(6) and (7) on decisions that the export can proceed in the
absence of an explicit consent:
The Agency mentioned that there is a
relatively high number of cases in which they need to ask the Commission to
verify and subsequently amend/reject the decision (when relevant) due to clerical
errors (e.g. incorrect validity dates, missing translations of documents,
questionable supporting documentation). This slows down the process and, in
many cases, triggers requests for clarification from exporters. An enhanced role
for the Agency in this process could improve its efficiency and effectiveness.
Article 23 on updating annexes:
The Agency believes it would be beneficial for
it to be involved at an early stage in the adoption of amendments to the
Regulation. For example, it suggested checking the substance identity of
chemicals proposed for amendments to ensure consistency with processes under
the other legislations it manages. It also proposed that, based on Article 6(1)(f),
the Commission could consider asking for its support in identifying and proposing
further candidate substances for inclusion in the PIC Regulation. Finally, the
Agency would like to contribute to the planning of the entry into application of
amendments to the Regulation, in order to avoid co-occurrence with the annual
export notification peak in the winter.
Day-to-day exchanges between the Agency and the Commission:
According to the Agency, there is room for improvement in the timing of replies,
as delays create problems for the performance of its operational tasks.
2.3 The EU as a Party to the Rotterdam Convention
The Commission, as the EU DNA, is the main interface with the Secretariat of the
Convention. In particular, the Commission is responsible for:
Representation of the EU to the Rotterdam Convention.
Coordination of EU input on all technical issues related to the Convention, the
preparation of the CoP, the CRC and other subsidiary bodies of the CoP.
Submission to the Secretariat of relevant FRA notifications concerning chemicals
qualifying for PIC notification.
Transmission of information on other FRA involving chemicals not qualifying for
PIC notification.
Submission to the Secretariat of EU import responses for chemicals subject to the
PIC procedure.
Exchange of information with the Secretariat in general.
The Member States, as Parties to the Convention, also participate in the CoP, the CRC
and activities under the Convention, such as the intersessional working group on the
process of listing chemicals in Annex III to the Convention. The Member States and their
DNAs provide input to the EU position on matters discussed at the CoP. Some DNAs also
participate in technical assistance activities under the Convention, to which the Agency
also contributes.
14
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1954637_0017.png
2.3.1 Coordination of Union input to the Conference of the Parties
(CoP)
The 7
th
Conference of the Parties to the Rotterdam Convention took place from 4 to 15
May 2015 (thus during the reporting period), back-to-back with the 12
th
CoP to the
Basel Convention and the 7
th
CoP to the Stockholm Convention.
Before CoP 7, the Commission prepared the draft position of the EU on matters
discussed at the meeting:
A proposal for a Council Decision establishing the EU position on amendments to
Annex III to the Convention, seeking a mandate for decision-making at the CoP.
This document was then discussed by the Council Working Party on International
Environmental Issues and by the Council Working Party on Environment, and
adopted by the Council on 6 March 2015.
A position paper, discussed with the Member States at the Council Working Party
on International Environmental Issues’ meetings, outlining the position to be
taken on the various items that would be discussed at the CoP. The final version
of this position paper was adopted in April 2015.
A position paper on budget and management issues covering the Rotterdam,
Basel and Stockholm Conventions, as the Programmes of Work and budgets of
the three Conventions were addressed in a joint session.
A position paper on technical assistance and financial issues, also covering each
of the Rotterdam, Basel and Stockholm Conventions.
After CoP 7, the Commission presented the outcomes of the CoP to DNAs at the 26
th
DNA meeting on 21 October 2015. The Commission also submitted, together with the
Presidency, an information note on the outcomes of the CoPs of the Rotterdam, Basel
and Stockholm Convention, transmitted by the General Secretariat of the Council to the
delegations on 10 June 2015. In addition, all of the statements made during the CoP on
behalf of the EU by the Commission and on behalf of the EU and its Member States by
the Presidency were published, together with the statements made at the 12
th
CoP to
the Basel Convention and the 7
th
CoP to the Stockholm Convention, through an
information note of the General Secretariat of the Council to delegations on 6 July 2015.
2.3.2 Participation in committees and expert groups
During the reporting period, the EU had five or six members nominated as experts in the
CRC, including two representatives in the bureau: Mr Jürgen Helbig from the
Commission, nominated by Spain, who acted as Chair for three meetings of the CRC
during the reporting period (October 2014, October 2015 and September 2016), and Ms
Magdalena Frydrych, nominated by Poland, acting as Vice-chair (see Table 6).
Table 6: EU Members of the CRC during the reporting period
CRC meetings
CRC-10, October 2014
CRC-11, October 2015
EU Members of the CRC
Ms Anja Bartels (Austria)
Ms Parvoleta Angelova Luleva (Bulgaria)
Ms Mirijam Seng (Germany)
Ms Leonarda Christina van Leeuwen (Netherlands)
Ms Magdalena Frydrych (Poland)
Mr Jürgen Helbig (Spain)
Ms Anja Bartels (Austria)
Ms Parvoleta Angelova Luleva (Bulgaria)
Ms Mirijam Seng (Germany)
Ms Leonarda Christina van Leeuwen (Netherlands)
Ms Magdalena Frydrych (Poland)
Mr Jürgen Helbig (Spain)
15
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1954637_0018.png
CRC meetings
CRC-12, September 2016
EU Members of the CRC
Ms Parvoleta Angelova Luleva (Germany)
Ms Leonarda Christina van Leeuwen (Netherlands)
Ms Magdalena Frydrych (Poland)
Mr Jürgen Helbig (Spain)
Ms Johanna Peltola-Thies (UK)
Eight EU experts were also nominated to the intersessional working group on the
process of listing chemicals in Annex III to the Convention:
Mr Björn Hansen (European Commission)
Mr Jürgen Helbig (European Commission)
Ms Anja Bartels (Austria)
Ms Mara Curaba (Belgium)
Ms Jutta Emig (Germany)
Ms Silvija Nora Kalnins (Latvia)
Ms Magdalena Frydrych (Poland)
Mr Richard Vincent (UK)
2.3.3 Financial contributions to the Rotterdam Convention
As a Party to the Rotterdam Convention, the EU paid the mandatory contribution to the
Convention’s Trust Fund and also contributed to the Special Voluntary Trust Fund for the
implementation of the programme of work for technical assistance (see Table 7).
Table 7:
Financial contributions from the EU to the Rotterdam Convention’s Trust Fund and Special
Voluntary Trust Fund (EUR)
7
Year
2014
2015
2016
EU contribution to Trust Fund
51,195
55,474
54,582
EU contribution to Special Voluntary
Trust Fund
277,331
302,815
513,603
As all Member States are Parties to the Convention, they also contribute to the
Convention’s Trust Fund through their mandatory contributions to the budget of the
Convention adopted by the CoP. In addition, some Member States contribute to the
Special Voluntary Trust Fund (see Table 8).
Table 8:
Member States’ contributions to the Special Voluntary Trust Fund (EUR)
Member State
Finland
France
Germany
Netherlands
Sweden
2014
0
0
0
84,325
0
2015
79,900
5,000
20,000
70,000
23,000
2016
0
0
14,950
61,000
0
7
From the Rotterdam Convention website, amounts converted from USD to EUR at November 2017 rates.
16
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3 U
PDATES OF
A
NNEX
I
AND
A
NNEX
V
TO THE
PIC R
EGULATION
According to Article 23, the list of chemicals in Annex I should be reviewed at least once
a year by the Commission on the basis of the developments in EU law (mainly in the
REACH Regulation, the BPR and the PPPR) and under the Convention. Annexes to the
PIC Regulation are amended through delegated acts adopted by the Commission. Since
the procedure for adoption of delegated acts is rather new, the Commission explained at
the 23
rd
and subsequent DNA meetings that it does not require the opinion of a
comitology committee but, rather, the consultation of an expert group. That consultation
is undertaken by presenting the draft amendment at the PIC DNA meeting and inviting
comments from all of the Member State experts present, together with other
stakeholders. In addition, the delegated act adopted by the Commission is submitted to
the European Parliament and the Council, and only enters into force if neither objects.
3.1 Update of Annex I
Amendments to Parts 1 and 2 of Annex I are triggered by regulatory actions changing
the legal status of a substance under other relevant EU legislation, in particular:
Decision not to approve or to withdraw an active substance under the PPPR;
Decision not to approve or to withdraw an active substance under the BPR;
Decision to subject a chemical to authorisation by adding it to the Authorisation
List (Annex XIV) of the REACH Regulation;
Decision to restrict the use of a chemical (Annex XVII) under the REACH
Regulation.
During the reporting period, two Delegated Regulations amending Annex I were
adopted, in 2014 and 2015 (see Table 9). Of the substances added to Annex I, many
were proposed for inclusion in Parts 1 and 2 of Annex I of the PIC Regulation having
been already banned for use as pesticides under Regulation (EC) No 1107/2009. This is
the case for bitertanol, cyhexatin, azocyclotin, cinidon-ethyl, cyclanilide, ethoxysulfuron,
oxadiargyl, didecyldimethylammonium chloride, and warfarin in 2014, and fenbutatin
oxide in 2015. In addition, substances severely restricted as pesticides, such as
rotenone and cyfluthrin, were added to Annex I in 2014.
Lead compounds, dibutyltin compounds, dioctyltin compounds, trichlorobenzene,
pentachloroethane,
1,1,2,2-tetrachloroethane,
1,1,1,2-tetrachloroethane,
1,1,2-
trichloroethane and 1,1-dichloroethene were added to Annex I in 2015, as these are
severely restricted as industrial chemicals for public use, in accordance with REACH.
Amendments to Part 3 of Annex I reflect the decision of the CoP to include certain
chemicals in Annex III of the Convention, making them subject to the PIC procedure.
Azinphos-methyl,
perfluorooctane
sulfonic
acid,
perfluorooctane
sulfonates,
perfluorooctane
sulfonamides
and
perfluorooctane
sulfonyls,
commercial
pentabromodiphenyl ether, including tetra- and pentabromodiphenyl ether, as well as
commercial octabromodiphenyl ether, including hexa- and heptabromodiphenyl ether
were included in Part 3 of Annex I during the reporting period, following their inclusion
in Annex III to the Rotterdam Convention.
17
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1954637_0020.png
Table 9: Substances added to Annex 1 during the reporting period
Delegated Act
Commission
Delegated
Regulation
(EU)
No 1078/2014 of
7 August 2014
amending Annex I
to Regulation (EU)
No 649/2012
Chemical
Azocyclotin
Bitertanol
Cinidon-ethyl
Cyclanilide
Cyfluthrin
Cyhexatin
Ethoxysulfuron
Didecyldimethylammonium
Chloride
Oxadiargyl
Rotenone
Warfarin
Azinphos-methyl
Perfluorooctane sulfonic acid
Perfluorooctane sulfonates
Perfluorooctane sulfonamides
Perfluorooctane sulfonyls
1,1-Dichloroethene
1,1,2-Trichloroethane
1,1,1,2-Tetrachloroethane
1,1,2,2-Tetrachloroethane
Dibutyltin compounds
Dioctyltin compounds
Fenbutatin oxide
Lead compounds
Pentachloroethane
Trichlorobenzene
Commercial
pentabromodiphenyl ether,
including: tetrabromodiphenyl
ether, and pentabromodiphenyl
ether
Commercial octabromodiphenyl
ether, including
hexabromodiphenyl ether and
heptabromodiphenyl ether
Amendment
of Annex I
Part 1 and 2
Part 1 and 2
Part 1 and 2
Part 1 and 2
Part 1and 2
Part 1 and 2
Part 1 and 2
Part 1
Part
Part
Part
Part
Part
Part
Part
Part
Part
Part
Part
Part
Part
Part
Part
Part
Part
Part
Part
1 and 2
1 and 2
1
3
3
3
3
3
1
1
1
1
1
1
1 and 2
1
1
1
3
Basis
inclusion
PPPR
PPPR
PPPR
PPPR
PPPR
PPPR
PPPR
PPPR
PPPR
PPPR
PPPR
Annex III
Annex III
Annex III
Annex III
Annex III
REACH
REACH
REACH
REACH
REACH
REACH
PPPR
REACH
REACH
REACH
Annex III
for
to
to
to
to
to
RC
RC
RC
RC
RC
Commission
Delegated
Regulation
(EU)
2015/2229 of 29
September 2015
amending Annex I
to Regulation (EU)
No 649/2012
to RC
Part 3
Annex III to RC
18
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1954637_0021.png
The inclusion of other substances in Annex I was discussed in 2016, but has not yet
been formally adopted through a Delegated Regulation (see Table 10).
Table 10: Chemicals proposed for inclusion in Annex I
Chemical
Tepraloxydim
Carbendazim
Triflumuron
Triclosan
cybutryne
2,4-dinitrotoluene
4,4’-
diaminodiphenylmethane
(MDA)
5-tert-butyl-2,4,6-trinitro-
m-xylene
benzyl butyl phthalate
Diisobutyl phthalate
Diarsenic pentaoxide and
tris(2-chloroethyl)
phosphate
Methamidophos
Amendment of Annex I
Part 1 and 2
Part 1 and 2
Part 1
Part 1 and 2
Part 1 and 2
Part 1 and 2
Part 1 and 2
Basis for inclusion
PPPR
PPPR
BPR
BPR
BPR
REACH
REACH
Part 1 and 2
Part 1 and 2
Part 1 and 2
Part 1 and 2
REACH
REACH
REACH
REACH
Part 1 and 3
Annex III to RC
3.2 Updates of Annex V
At the 27
th
meeting of the DNAs in April 2016, an amendment to Annex V was discussed
the inclusion of hexabromocyclododecane in Part 1 of Annex V of the PIC Regulation.
Hexabromocyclododecane has been included in Part A of Annex I to Regulation (EC) No
850/2004 (Persistent Organic Pollutants (POPs) Regulation), since the decision was
taken under the Stockholm Convention to list this chemical in Part 1 of Annex A to the
Stockholm Convention. It should therefore be listed in Annex V of the PIC Regulation.
19
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4 O
PERATION OF THE
PIC R
EGULATION
4.1 Support to exporters and importers
The Agency is required to provide assistance, as well as technical and scientific guidance
and tools, to exporters and importers (Article 6(1)). Although it is not a legal obligation
under the PIC Regulation, most DNAs have provided support and carried out awareness-
raising activities for national exporters and importers during the reporting period.
Both the Agency and Member States were asked to provide information (in their
respective reporting questionnaires) on the awareness-raising and communication
activities carried out during the reporting period and requests received from exporters
and importers (Section 3 of Member State and the Agency’s questionnaires).
Both DNAs and the Agency stated that the support provided to companies, as well as
the awareness-raising activities carried out during the reporting period, had improved
exporter and importer compliance with the PIC Regulation.
4.1.1 Support provided by DNAs
Awareness-raising activities
Twenty-five Member States stated that they had carried out awareness-raising and
information activities for exporters and importers during the reporting period (see Figure
2). Member States that did not carry out any such activities were either small Member
States with little or no exports and imports falling within the scope of the Regulation, or
Member States providing information to exporters and importers on request.
The most common activities carried out by Member States were the provision of online
information, such as a specific webpage providing information on the PIC Regulation,
and references to the Agency’s webpages on PIC and ePIC. Ten Member
States also
provide a national helpdesk.
Other awareness-raising activities carried out by Member States included mail or
telephone correspondence between the DNA and importers or exporters, guidelines for
importers and exporters, and information spread through the Strategic Approach to
International Chemicals Management (SAICM) Platform.
Almost all of the Member States carrying out awareness-raising and information
provision activities considered such activities to have improved exporter and importer
compliance with the PIC Regulation. For example, some DNAs noted an increase in the
number of export notifications received by the DNA during the reporting period, an
increase in the number of companies registered in ePIC, or improved compliance with
the Article 10 reporting obligations.
20
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1954637_0023.png
Figure 2: Question 11. Have any awareness-raising and information activities been put in place by
the DNA(s) to support exporters and importers to comply with the PIC Regulation?
Spe ifi
e page pro idi g i for atio o the PIC…
Reference to ECHA webpages on PIC and ePIC
National helpdesk
Specific email address for information requirements
Workshops and similar training events
Others
O li e te h i al a d s ie tifi guida e (other tha …
Awareness-raising campaign
Visits to operator establishments
Social media
0
5
10
15
20
25
Number of Member States
Requests from exporters and importers
The most frequent requests from exporters and importers to DNAs relate to export
notifications and explicit consents (see Figure 3).
Estimated amount of time spent on support
In the majority of Member States, providing support to exporters and importers takes
less than 10% of the DNA’s working time. This rises to 40% in three Member States.
Figure 3: Question 13. On which matters do(es) the DNA(s) get the two most frequent requests for
support coming from exporters and importers?
Export notification
Explicit consent
Special RIN
Article 10 reporting
Others
Waiver
0
5
10
15
20
25
30
Number of Member States
4.1.2 Support provided by the Agency
Awareness-raising activities
The Agency has fulfilled its obligations under Article 6 of the PIC Regulation through the
following activities:
Technical and scientific guidance
The Agency published version 1.0 of the
Guidance for implementation of Regulation (EU)
No 649/2012 concerning the export and import of hazardous
chemicals (‘Guidance on
21
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1954637_0024.png
PIC’) in December 2014 (in English only) and a corrigendum to it (version 1.1) in July
2015 (to take into account the end of certain CLP transition periods). Translations of
version 1.1 into 14 languages (Bulgarian, Croatian, Czech, Danish, Dutch, German,
Finnish, French, Spanish, Italian, Polish, Portuguese, Slovenian and Swedish) were
published in March 2016, with translations into the remaining eight official EU languages
(Estonian, Greek, Hungarian, Latvian, Lithuanian, Maltese, Romanian and Slovak)
published in October 2016.
Webpages on the PIC Regulation and ePIC
The
Agency
has
created
a
specific
webpage
on
the
PIC
Regulation
(https://echa.europa.eu/regulations/prior-informed-consent-regulation)
and a webpage
dedicated to ePIC (https://echa.europa.eu/support/dossier-submission-tools/epic). These
pages are in all official EU languages.
Internal messaging in ePIC
The communication via messages sent in ePIC is typically used in the following cases:
To remind exporters/importers of upcoming legal deadlines;
To advertise publication of updated user manuals, new factsheets, etc.;
To inform of policy changes;
To alert users in advance of maintenance breaks.
Awareness-raising campaign
The Agency reminds exporters and importers of PIC-related news, such as upcoming
legal deadlines or workload peaks, using different communication means, including the
weekly e-News and the Agency Newsletter. These channels are also used to highlight
new substances added to Annex I or included in group entries.
Support to individual companies
This is done through replies to Helpdesk incidents and/or telephone support.
Workshops, webinars and similar training events
The Agency has organised a number of workshops on PIC, mainly related to the initial
development of ePIC:
Three workshops for Member States and industry representatives organised at
the Agency’s premises during
the development of ePIC (June 2013, November
2013 and May 2014) in order to gather their feedback and invite their
contributions to the application specifications.
WebEx discussions during the development of the ePIC system.
Training workshop organised
at the Agency’s premises in September 2014, just
after the launch of the ePIC system, to instruct users on the use of ePIC
application.
In addition, the Agency takes part in conferences and training, seeing them as an
opportunity to reach out to industry directly, to provide updates on ePIC and policy
issues, and to address specific concerns.
IT user manuals, factsheets and Q&A (FAQs)
After the launch of ePIC, the Agency published a user manual, which was subsequently
translated into all official EU languages and is updated every time there is a new release
of the application. The Agency has also prepared factsheets dedicated to specific topics
and has a Q&A document on ePIC, which is updated in parallel with new releases of the
application.
According to the Agency, these activities have improved exporter and importer
compliance with the PIC Regulation. Similarly, it partially attributes the increase in the
number of companies registered in ePIC (390 in March 2014 compared to 1177 at the
end of the reporting period) to the awareness-raising activities and the visibility given to
ePIC.
22
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Requests from exporters and importers
Through its helpdesk, the Agency received 123 requests for information or support from
exporters and importers in 2014, 245 in 2015 and 227 in 2016.
The largest number of requests from exporters and importers’ concerned:
Scope-related issues: which chemicals are subject to the PIC Regulation;
Reasons why an export has not been allowed to proceed;
Exporters’ obligations under the
PIC Regulation, as determined by the listing of a
chemical in Annex I;
Clarification on which Member State shall receive the export notification (e.g.
where the legal entity holding the contract for an export is in one Member State
but the shipment is leaving from a different Member State);
Article 10 on the reporting required of exporters and importers during the first
quarter of each calendar year.
In addition, the Agency received a low number of more complex questions, e.g. the link
between the PIC Regulation and other legislation, the triggering of labelling obligations
for mixtures under CLP, or the responsibility for the export notification when the
manufacturer is based outside the EU but chemicals are shipped from the EU to third
countries.
Estimated amount of time spent on such support
Four FTEs working in the Dossier Submission & PIC Unit provide replies to the requests
received from companies. This task takes approximately 10% of their time, on average.
4.2 Export notifications forwarded to Parties and other countries
(Article 8)
The export notification is the instrument under the PIC Regulation by which countries
exchange information on banned or severely restricted chemicals. All EU based
exporters must submit an export notification to their DNA if they intend to export
chemicals listed in Part 1 of Annex I to the PIC Regulation to a third country (Party or
non-Party to the Rotterdam Convention), irrespective of the use of the chemical in the
country of destination. Once the DNA has checked and accepted the notification (after
resubmission if necessary), it is forwarded to the Agency, which also verifies the
compliance of the notification and transmits it to the DNA of the importing country. If no
acknowledgement of receipt is received, the Agency re-sends the notification. The whole
procedure is carried out by means of ePIC, and exporters must use the notification
template provided by the system.
DNAs and the Agency were asked to provide data on the number of export notifications
and Special RIN requests processed during the reporting period, information on
difficulties encountered by exporters and authorities in carrying out the procedures,
emergency situations, and the provision of additional information on exported chemicals.
The number of export notifications and Special RIN requests increased between 2014
and 2016, and their number varied significantly between Member States. According to
the Agency, this shows that compliance has increased during the reporting period. In a
relatively high number of cases, the DNAs or the Agency requested resubmission of a
notification, usually relating to issues with section 6 of the notification form (summary
of, and reasons for, the FRA and date of entry into force) and to the SDS (inappropriate
language or SDS not matching the notification). Although some DNAs and the Agency
reported problems in complying with the timeframes of the notification procedure, the
number of notifications processed late remained low.
23
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1954637_0026.png
4.2.1 Export notifications processed during the reporting period
8
During the reporting period, DNAs accepted and forwarded to the Agency 15,771
notifications, and rejected 1,214 notifications
9
.
The number of export notifications processed varies significantly between Member
States (see Figure 4). Four Member States did not process any export notification during
the reporting period (Latvia, Lithuania, Luxembourg and Slovakia) and five Member
States processed fewer than 10 notifications. The highest numbers of export
notifications during the reporting period were in Germany (5,196 notifications), France
(3,358), the UK (1,829), Italy (1,321) and Spain (1,265). The importing countries that
received the highest numbers of export notifications from the EU were Switzerland
(1,044 notifications), Turkey (984), Russia (890), the USA (754) and China (601).
Figure 4: Total number of export notifications accepted and forwarded to the Agency by DNAs
during the reporting period
10000
DE
FR
UK
Notifications forwrded to ECHA
1000
AT
IT
BE
NL
PL
DK
ES
SE
100
BG
CZ
HR
FI
HU
IE
PT
SI
10
CY
MT
RO
1
EE
EL
Member States
The number of export notifications accepted and forwarded to the Agency by DNAs
increased significantly during the reporting period, from 1,553 in 2014, to 5,866 in
2015, to 8,352 in 2016
10
(see Table 11).
8
This section and those that follow are based on data extracted from ePIC by the Agency and provided to the
Commission, the DNAs and the consultant.
Figures provided by DNAs include rejected/re-submitted
notifications, in addition to ‘validated’ notifications
(i.e. accepted and processed).
For 2014 the period covered is 1 March
31 December (as the PIC Regulation became applicable on 1
March 2014).
9
10
24
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1954637_0027.png
The Agency also reported an increase in the number of export notifications accepted and
processed during the reporting period, from 4,575 in 2014, to 5,460 in 2015, to 7,967 in
2016
11
, thus beyond the 10% increase originally envisaged (see Table 11). The number
of companies involved in PIC activities has also increased substantially, from 390 in
2014 to 1,177 in 2016
12
. The Agency concluded from this increase that awareness and
compliance with the Regulation has significantly improved during the reporting period.
The main factor that contributes to this increase is the inclusion of new chemicals in
Annex I. Table 11Error!
Reference source not found.
summarises the activities
carried out by the Agency in relation to export notifications during the reporting period.
Table 11: Export notifications and related tasks handled by the Agency during the reporting period
Export
notifications
handled
(including
initial
submissions,
resubmissions and rejections)
Export notifications forwarded
Acknowledgments of receipt received
Export notifications forwarded a
second time
2014
1,550
13
2015
5,845
2016
8,335
460
190
270
4,642
3,077
1,565
7,229
4,575
2,654
An acknowledgement of receipt is requested by the Agency for all export notifications
sent (not just the first one after Annex I inclusion, as stated in Article 8(3)), as this is an
important means of ensuring that the information has been received, especially as
contact details in non-EU countries change frequently.
4.2.2 Special RIN requests processed during the reporting period
Exporters of chemicals exported for research or analysis purposes in quantities that do
not exceed 10kg from each exporter to each importing country per calendar year use
the Special RIN request procedure, in which the exporter requests a Special RIN from
the DNA. If the request is accepted, this activates a Special RIN that the exporter can
use on the customs declaration. The Special RIN request procedure is also used in cases
where the exporter is exempt from export notifications, such as emergency situations,
when a positive import response has been given by the importing party and when a
country has waived its right to be notified.
During the reporting period, 17 Member States accepted 7,072 Special RIN requests.
Eleven Member States did not have to deal with any such request in the past three
years (Bulgaria, Cyprus, Estonia, Greece, Hungary, Latvia, Lithuania, Luxembourg,
Malta, Romania, and Slovakia). Germany, the UK and Belgium were the Member States
that accepted the highest number of Special RIN requests (see Figure 5).
11
Figures provided
for the Agency only include ‘validated’ notifications (i.e. accepted and processed) and
exclude rejected/re-submitted notifications, which explains the discrepancy with the figures provided for
DNAs.
ECHA, Increase in notifications providing information on the export of hazardous chemicals, press release
ECHA/PR/17/15, 6 September 2017:
https://echa.europa.eu/-/increase-in-notifications-providing-
information-on-the-export-of-hazardous-chemicals
Data available from 1 March 2014 (all other data in this column were available after go-live of the PIC
submission system, i.e. 2 September 2014).
12
13
25
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1954637_0028.png
Figure 5: Total number of Special RIN requests accepted by DNAs during the reporting period
10000
Special RIN requests forwarded to ECHA
DE
1000
BE
FR
AT
100
CZ
HR
10
DK
FI
1
PT
IE
IT
NL
PL
SI
SE
ES
UK
Member States
4.2.3 Requests
for
notifications
resubmission
and
rejection
of
export
Member States requested the resubmission of 2,904 export notifications during the
reporting period. Figure 6 shows the significant variations between Member States.
Figure 6: Total number of resubmissions of export notifications requested by DNAs
14
in the
reporting period
France
Germany
Spain
United Kingdom
Italy
Belgium
Austria
Denmark
Finland
Netherlands
Poland
Portugal
Hungary
Bulgaria
Ireland
0
1173
525
327
287
242
79
77
48
30
23
17
15
15
15
14
200
400
600
800
1000
1200
1400
Total number of resubmissions requested by DNAs
14
Only Member States that requested the resubmission of more than 10 notifications are represented on the
graph.
26
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1954637_0029.png
DNAs explained that resubmission of notifications were necessary where information
requirements were not met. Several DNAs further specified the missing or incorrect
information typically triggering the request for resubmission:
Information requirements not met in section 6 of the export notification form
summary of, and reasons for, the FRA and date of entry into force (five DNAs).
Information requirements not met in section 1 of the export notification form
identity of the chemical subject to the export notification: CAS number,
concentrations, name of product (one DNA).
Information requirements not met in section 3 of the export notification form
information concerning the export, e.g. phone number, importer address (one
DNA). One DNA also reported that in some cases exporters incorrectly ticked the
emergency situation box in order to avoid the 35-day waiting period.
Information requirements not met in section 4 of the export notification form
information on hazards and/or risks of the chemical and precautionary measures,
e.g. wrong classification (one DNA).
Several Member States also highlighted problems with the SDS attached to export
notifications:
The SDS was not submitted in the correct language (five DNAs).
The SDS did not match the export notification (four DNAs). Two DNAs specifically
mentioned inconsistencies in the composition of mixtures. Italy also pointed to
cases where the type of product (substance / mixture) was different on the SDS
and notification form.
Two DNAs mentioned errors on the SDS, in particular relating to codes.
The Agency requested the resubmission of 609 export notifications during the reporting
period (43 in 2014
15
, 334 in 2015, and 232 in 2016). The main reasons for requesting
resubmission of a notification were:
Issues with the data provided in Section 6.1 ‘Summary of and reasons for the
final regulatory action and date of entry into force’ (incorrect text/language).
Problems with the SDS: incorrect SDS attached to the notification; SDS
unavailable because attached in the incorrect place in ePIC; SDS language
incorrect.
Discrepancy between the data on the substance/mixture composition on ePIC
and on the SDS.
Member States rejected 1,214 export notifications during the reporting period. Figure 7
shows the numbers of rejected notifications for those Member States in which rejections
occurred most frequently.
15
Data only available after go-live of the PIC submission system (2 September 2014)
27
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Figure 7: Total number of export notifications rejected by DNAs during the reporting period
16
United Kingdom
Spain
France
Germany
Belgium
Italy
Netherlands
0
42
32
20
100
200
300
400
500
600
99
84
205
692
700
800
Total number of notifications rejected by DNAs
12 Member States stated that export notifications were rejected because they were not
applicable for the following reasons:
Duplication of notifications (10 DNAs).
The resubmission occurred too late (one DNA).
The emergency situation was not justified (one DNA).
Conditions for granting a special RIN were met (two DNAs).
Rejection requested by exporting company (two DNAs).
PIC chemical missing in mixture (one DNA).
Other Member States indicated
notification:
Information requirements
DNAs).
Wrong identification, e.g.
DNA).
Missing SDS in appropriate
that rejection was based on flaws in the export
not met or incorrect information provided (three
substance notified as mixture and vice versa (one
language (two DNAs).
Finally, one DNA pointed to cases where a notification was rejected because of the
negative consent received from the importing country.
The Agency rejected 175 notifications during the reporting period (51 in 2015 and 124 in
2016). In 2015, a large number of export notifications for didecyldimethylammonium
chloride were rejected because the substance was notified in a mixture at a
concentration level which did not trigger labelling of the mixture, irrespective of the
presence of any other substance (in accordance with Article 8(1)). In 2016, 124
notifications were rejected because the importing country had waived the requirement
to receive export notifications for exports of certain chemicals from the EU, or because
the mixture was not classified as hazardous, based on the information provided in the
SDS.
4.2.4 Difficulties encountered in the export notification procedure
Difficulties encountered by exporters in completing the export notification form
According to the Agency and DNAs, exporters have experienced difficulties in providing
information on the export (e.g. contact details of importers) and the intended use of the
chemical in the importing country (see Figure 8).
16
Only Member States that rejected more than 10 notifications are represented on the graph.
28
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1954637_0031.png
Figure 8: Question 19. What are the information requirements requested in the export notification
form where exporters have difficulties in providing the information?
Availability of CN codes or CUS codes
I for atio
o er i g the e port (e.g. o ta t details…
Intended use of the chemical in the importing country
I for atio o the fi al regulator a tio take
the…
None
Su
ar of a d reaso s for fi al regulator a tio a d…
Additional information provided by the exporting Party
Identity of the mixture to be exported
I for atio o hazards or risks of the he i al a d…
Identity of the substance to be exported
Su
ar of ph si o- he i al, to i ologi al a d…
Identity of the article to be exported
0
2
4
6
8
10
12
14
Number of Member States
In addition, the Agency indicated that the identity of the substance to be exported and
the summary of, and reasons for, the FRA and date of entry into force had also proved
problematic for exporters. Twelve DNAs also stated that the availability of Combined
Nomenclature (CN) or Customs Union and Statistics (CUS) codes were a particular
problem for exporters.
In addition to these issues, several DNAs highlighted other problem areas:
Two DNAs mentioned that providing the SDS in the correct language was an
issue for some exporters.
One DNA stated that the grouping of chemicals was a particular problem, and
that biocides were sometimes considered industrial chemicals and other times
pesticides.
One DNA indicated problems with the identification of research or analysis use
and applications for Special RIN requests.
One DNA mentioned problems with the identification of mixtures falling within the
scope of the Regulation.
The Agency also noted the following problems or mistakes:
If their chemical is not in ePIC, companies are not sure whether or not its export
is subject to the PIC Regulation (this issue relates specifically to group entries,
e.g. cadmium and its compounds, for which the list of cadmium compounds in
ePIC is not comprehensive).
Some exporters confuse export notifications for substances and mixtures.
Section 3.1 of the export notification (foreseen category and foreseen use in
importing country) is often confused with section 6.2 (category for which the FRA
was taken).
The intended use and use category for exports of biocides can be problematic
due to the fact that the EU considers ‘biocides’ to be a sub-category
of the
pesticides category, whereas many non-EU countries consider biocides industrial
chemicals.
29
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Some companies insert controversial, non-factual messages in section 6.1 on the
FRA (e.g. they disagree with the fact that the substance was banned or severely
restricted in the EU) that are not acceptable, and the Agency has to ask for such
statements to be removed.
Not all companies provide the SDS (or equivalent information) in the official
language of the importing country or in an appropriate language.
The definition of an exporter (Article 3(18)) was not always easily applicable to
certain cases in which, for example, the holder of the contract was in a non-EU
country (Switzerland) but the export was physically shipped from the EU.
The obligation to notify the export of an article is set out in Article 15, in
conjunction with Article 3(4). It was often unclear to exporters, DNAs and the
Agency whether or not a given article is subject to the PIC Regulation.
Complying with timeframes
According to the Agency, some DNAs experienced difficulties in coping with the
timeframe to forward the export notifications. However, the number of export
notifications it received less than 25 days before the export remains relatively low
compared to the total number of notifications processed (725, or 4.9% of the total
number of notifications).
Seven Member States stated that they experienced such difficulties during the reporting
period. In particular, four Member States indicated that they have difficulties in
complying with the timeframes during the ‘peak season’ in winter. Two Member States
mentioned that companies did not respect deadlines for resubmission, thereby delaying
the whole procedure. The Agency explained that where the exporter had submitted the
export notification on time and the delay was in fact due to late processing by the DNA,
they processed the late export notification in order not to further penalise the exporter
and to allow the export process to continue. The Agency added that the authority in the
importing country is always alerted by a separate communication where an export
notification was delivered less than 15 days before the expected date of export (as
foreseen by Article 8(2) of the PIC Regulation).
The Agency indicated that it, too, experienced difficulties in coping with the timeframe to
process and forward export notifications to the importing country. However, the number
of late notifications remains very low. 171 notifications were sent late to the importing
countries, around 1.2% of the total number of export notifications forwarded to
importing countries during the reporting period. This is mostly due to delays in receiving
the notifications from the DNAs. In 30 cases, however, the delay was caused by the
Agency itself, mainly because of IT issues. According to the Agency, the authority in the
importing country is always informed accordingly.
4.2.5 Emergency situations (Article 8(5))
According to Article 8(5), when the export relates to an emergency situation in which
any delay may endanger public health or the environment in the importing country, the
DNA, in consultation with the Commission, may exempt the exporter from the
notification requirements or the waiting period. According to the Agency and the DNAs,
only a small number of export notifications referred to an emergency situation, most of
which did not meet Article 8(5) criteria and were rejected. Only two DNAs (Belgium and
Greece) stated that they had to deal with an emergency situation during the reporting
period. In Belgium, the export notification was rejected as it did not meet Article 8(5)
criteria. In Greece, the emergency situation concerned 1,3-dichloropropene imported by
Turkey, requesting a 120-day authorisation to use the chemical as a soil fumigant.
30
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1954637_0033.png
4.2.6 Provision of available additional information on exported
chemicals
According to Article 8(7), the Commission, DNAs, the Agency and exporters should
provide additional information on the exported chemicals, at the request of the
importing party. The Agency received many requests to provide additional information
or clarifications on exported chemicals to importing parties and other countries. These
typically related to additional information on the importing company, clarification on the
intended use of the chemical in the importing country or on the quantities exported,
clarification on the reasons for notifying the export of the chemical or for requesting the
explicit consent for chemicals which are not listed in Annex III to the Rotterdam
Convention, and cases where the export notification was sent to the wrong authority.
Eight DNAs received similar requests. Information requested by the importing countries
related primarily to importer contact details. Other requested information related to the
chemical itself, e.g. name of the chemical, or information on the reasons for its ban or
restriction in the EU.
4.2.7 Administrative fee for export notifications
Member States are allowed to establish administrative fees for exporters for each export
notification and for each request for explicit consent made, corresponding to the cost
they incur in carrying out the procedures. Eight Member States request an
administrative fee for export notifications, and these fees vary greatly between Member
States (from EUR 25 to EUR 250). Three Member States request a fee for requests for
explicit consent. Member States received no complaints from exporters, nor did they
note any significant impact of the fee on the number of export notifications.
4.3 Export notifications from Parties and other countries (Article 9)
As per Article 9, the Agency must make available on its database the export notifications
it receives from third countries, acknowledge receipt of the notification to the DNA of the
exporting country and provide a copy to the DNA of the Member State(s) receiving the
import. The Agency was asked to provide information on the export notifications
received and acknowledgements sent.
The Agency received 1,105 export notifications from non-EU countries in the reporting
period (see Table 12). The number of notifications almost doubled between 2014 and
2016.
Table 12: Export notifications received from non-EU countries and acknowledgements sent during
the reporting period
Export notifications received
Acknowledgements sent
2014
209
3
17
2015
486
122
2016
410
92
Total
1,105
217
The difference between the number of notifications received and the number of
acknowledgements sent is due to the fact that the Agency does not send
acknowledgements of receipt to the US, based on a bilateral agreement between the
two parties, while the US is the country sending the greatest number of notifications to
the EU.
17
Data only available after go-live of the PIC submission system (2 September 2014).
31
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4.4 Information on export and import of chemicals (Article 10)
Article 10 places obligations on exporters and importers to inform the DNA of the
quantity of chemicals listed in Annex I of the PIC Regulation exported to or imported
from third countries during the preceding year. This must be done during the first
quarter of each year. Exporters must also provide the DNA with the names and
addresses of each importer. DNAs must, in turn, provide this information to the Agency
annually, which then aggregates the data at EU level and makes it publicly available on
its database.
DNAs and the Agency were asked (in their respective questionnaires) about any delays
and difficulties encountered in fulfilling their obligations under Article 10. Their
responses suggest that the reporting under Article 10 works well.
Delays in collecting information
Ten DNAs stated that several exporters had delayed the submission of information on
the quantity of the chemicals exported, but said that exporters generally submitted the
information after a reminder. Eight DNAs stated that they had experienced delays from
importers in submitting their information. These delays did not affect the completion of
the reporting exercise under Article 10, as the Agency did not encounter similar delays
from DNAs in receiving the aggregated national reports on the quantity of exported and
imported chemicals.
Reporting through ePIC
Very few DNAs reported problems with reporting through ePIC, with only two indicating
that they had experienced difficulties in their Article 10 reporting. Two DNAs indicated
that they experienced delays in submitting aggregated information through ePIC.
Aggregating information at EU level
According to the Agency, the aggregation of information was complicated by incorrect
reporting by some DNAs, which had included data on exports of PIC chemicals exported
for research and analysis purposes (below 10kg per year and per importing country).
These exports are out of the scope of Article 10 and should not be reported by DNAs.
Use of Article 10 data
Data gathered for the purposes of Article 10 reporting are used by the DNAs, customs or
other enforcement authorities in 16 Member States. Eight DNAs indicated that the data
are used for enforcement activities, with six specifying that it is used for REACH
enforcement activities (e.g. cross-checking compliance with registration requirements,
or checking compliance with restrictions).
4.5 Notification of banned or severely restricted chemicals under the
Convention (Article 11-12)
As per Article 11 of the PIC Regulation, the Commission must notify the Secretariat of
the Rotterdam Convention, in writing, of the chemicals listed in Part 2 of Annex I, which
qualify for PIC notification. The Commission, assisted by the Agency, drafted the
notifications and submitted these to the DNAs for comments before submitting them to
the Secretariat. Three notifications were submitted to the Secretariat during the
reporting period (see Table 13).
32
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Table 13: PIC notifications sent to the Secretariat during the reporting period
Basis for notification
Commission Regulation (EC) No 73/2013
(2014)
Commission Delegated Regulation (EU)
No 1078/2014
Chemicals notified after inclusion in Annex
Commission Delegated Regulation (EU)
No 2015/2229
Chemicals notified
Naled
Bitertanol
Fenbutatin oxide
Date of notification
2014
October 2016
October 2016
4.6 Obligations in relation to importing chemicals (Article 13)
As per Article 10 of the Convention, Parties are requested to adopt an import decision
for each new chemical listed in Annex III and to submit it to the Secretariat within nine
months of receipt of the notification of the listing and the decision guidance document.
Pursuant to Article 13 of the PIC Regulation, the import decision is adopted by means of
an implementing act. The Commission drafts the implementing act containing relevant
import decisions, which is then submitted to the REACH Committee for an opinion, in
accordance with the advisory procedure.
During the reporting period, the Commission adopted two Implementing Decisions (see
Table 14). In 2014, the Commission drafted import decisions for azinphos-methyl,
commercial
pentabromodiphenyl
ether,
commercial
octabromodiphenyl
ether,
perfluorooctane sulfonic acid, perfluorooctane sulfonates, perfluorooctane sulfonamides
and perfluorooctane sulfonyls, which were submitted to the REACH Committee on 7
April, with the Commission Implementing Decision adopted on 15 May 2014. In 2015,
the Commission drafted a new import decision for methamidophos and revised the
import decisions on DDT and ethylene oxide, which were submitted to the REACH
Committee in late 2015. The Implementing Decision was adopted on 11 February 2016.
Table 14: EU import responses adopted during the reporting period
Implementing
Act
Commission
Implementing
Decision of 15
May 2014
Chemicals
Azinphos-methyl
Commercial
pentabromodiph
enyl ether
Nature / status of
decision
New
Final
decision
New
Final
decision
Import
decision
No consent
to import
Consent to
import only
subject to
specified
conditions
Consent to
import only
subject to
specified
conditions
No consent
to import
Commercial
octabromodiphe
nyl ether
New
decision
Final
Perfluorooctane
sulfonic
acid,
perfluorooctane
sulfonates,
perfluorooctane
sulfonamides
and
perfluoro-
octane sulfonyls
New
decision
Final
Grounds for
decision
Banned for use
under PPPR
Banned for use,
subject to
specific
exemptions
under POPs
Regulation
Banned for use,
subject to
specific
exemptions
under POPs
Regulation
Banned for use,
subject to
specific
exemptions
under POPs
Regulation
33
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Implementing
Act
Commission
Implementing
Decision of 11
February
2016
Chemicals
Methamidophos
Ethylene oxide
Nature / status of
decision
New
Final
decision
Amending
Interim
previous
decision
DDT
Amending
previous
decision
Final
Import
decision
No consent
to import
Consent to
import only
subject to
specified
conditions
No consent
to import
Grounds for
decision
Banned for use
under PPPR
Banned for use
under PPPR and
restricted under
BPR
Banned for use
under POPs
Regulation
Article 13(5) requires the DNAs to make EU import decisions available to those
concerned within their competence. DNAs fulfil this requirement by email and by
publishing those decisions on their website.
4.7 Obligations in relation to exports of chemicals, other than export
notifications (Article 14)
Article 14 requires the explicit consent of the importing country before an export of
chemicals listed in Parts 2 or 3 of Annex I can proceed, unless a positive import
response is available in the latest PIC Circular for chemicals listed in Part 3 of Annex I.
DNAs and the Agency were asked to provide data on explicit consent procedures carried
out during the reporting period, as well as any difficulties they encountered in doing so.
Nineteen Member States implemented the explicit consent procedure during the last
three years, highlighting some importing countries’
difficulties in handling requests sent
by Member States as the main challenge. Fewer Member States dealt with Article 14(6)
and (7) provisions, and the information provided by DNAs suggests that few
implementation problems occurred. Although, according to the Agency, it was initially
challenging to interpret the cases to which Article 14(8) provisions applied, the number
of problem cases has nonetheless been reduced to a very low level.
4.7.1 Communication of information and decisions to those
concerned within the jurisdiction of a Member State (Article
14(3))
Article 14(1) requires the Commission to forward PIC circulars and other relevant
information received from the Secretariat of the Convention to Member States, the
Agency, and industry associations. The Member States then communicate this
information to those concerned in their jurisdiction. All DNAs fulfil this requirement,
mainly through emails and the provision of information on their website (Article 14(3)).
4.7.2 Explicit consent (Article 14(6))
18
During the reporting period, 19 Member States sought explicit consent from the DNA of
the importing country, under Article 14(6)(a). A total of 3,362 requests for explicit
consent were handled by DNAs (see Figure 9).
18
This section and those that follow are based on data extracted from ePIC by the Agency and provided to the
Commission, the DNAs and the consultant.
34
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Figure 9: Number of requests for explicit consent received by DNAs during the reporting period
19
10000
Requests for explicit consent
1000
DE; 1286
FR; 559
BE; 283
NL; 204
IT; 142
PL; 47
AT; 27
CZ; 21
FI; 20
HU; 20
IE; 10
HR; 4
CY; 3
DK; 3
PT; 2
SI; 4
SE; 113
ES; 376
UK; 238
100
10
1
Member States
Of the 3,362 requests for explicit consent, 56% were answered. The share decreased
over the reporting period (61% in 2014, 58% in 2015, and 51% in 2016). This
explained why the Agency had to send a significant number of reminders. A first
reminder was sent for 65% of the requests, and a second reminder for 42% of the
requests (see Table 15).
Table 15: Reminders for explicit consent requests sent by the Agency during the reporting period
2014
2015
2016
Total
First reminder
469
826
899
2,194
Second reminder
235
627
563
1,425
During the reporting period, there were four instances in France and Germany where for
chemicals listed in Part 3 of Annex I, explicit consent from the DNA of the importing
country was provided by the latest circular issued by the Secretariat of the Rotterdam
Convention, according to Article 14(6)(b) (see Table 16).
Table 16: Number of requests for explicit consent pursuant to Article 14(6)(b)
Member State
France
Germany
2014
0
0
2015
0
0
2016
1
1
Total
1
1
19
For 2014, the period covered is 1 March-31 December (as the PIC Regulation became applicable on 1 March
2014).
35
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Difficulties
procedure
encountered
in
the
implementation
of
the
explicit
consent
Eight Member States reported having experienced difficulties in implementing the
explicit consent procedure. According to most DNAs, the main challenge was late
responses from importing countries to consent requests (i.e. after the 60-day waiting
period) or no response at all. The DNAs also stated that the response provided was not
always clear or was difficult to interpret, that certain countries were particularly difficult
to reach (e.g. where the request had to be sent by regular mail), and that certain
countries imposed additional national rules that caused further delays.
The Agency’s involvement in the explicit consent procedure consists of verifying the
metadata associated with explicit consent requests after it is uploaded to ePIC by the
DNA (and before it can be used for processing purposes). According to the Agency, this
process has worked smoothly in recent years and has contributed to harmonised data
and the reduction of clerical errors during the procedure.
The Agency also mentioned that it had agreed a procedure with the Commission and the
EU DNAs for the handling of requests for explicit consent received from a non-EU
country, as the PIC Regulation does not provide any such procedure. This procedure, it
stated, could be reflected in the legal text.
4.7.3 Waivers (Article 14(6) and (7))
Explicit consent in case of exports of chemicals listed in Part 2 of Annex I to
OECD countries
According to Article 14(6), when a chemical qualifying for PIC notification is exported to
an OECD country, the DNA can waive the requirement for explicit consent on a case-by-
case basis, at the request of the exporter and after consulting the Commission. Six
Member States were requested to decide whether or not explicit consent was required in
the case of export of chemicals listed in Part 2 of Annex I to OECD countries (see Table
17). None of the Member States experienced difficulties in taking such a decision.
Table 17: Number of cases where DNAs were required to decide whether or not explicit consent
was required in case of export of chemicals listed in Part 2 of Annex I to OECD countries
Member State
France
Germany
Italy
Netherlands
Sweden
United Kingdom
2014
0
0
15
0
0
0
2015
8
2
19
1
2
1
2016
1
0
15
3
1
0
Total
9
2
49
4
3
1
DNA decisions that export may proceed 60 days after an explicit consent
request was made
According to Article 14(7), the DNA of the exporting country can take the decision, on a
case-by-case basis and in consultation with the Commission, assisted by the Agency, to
waive the explicit consent requirement when no reply from the importing country has
been received after 60 days. Such waivers can only be granted if certain conditions are
met and for a maximum period of 12 months, after which time the exporter will need to
seek explicit consent again. Eleven Member States received waiver requests in
accordance with Article 14(7) during the reporting period (see Table 18).
36
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Table 18: Number of waiver requests received per Member State during the reporting period
Member State
Belgium
Finland
France
Germany
Hungary
Italy
Netherlands
Poland
Spain
Sweden
United Kingdom
2014
11
0
5
14
0
1
2
0
1
0
1
2015
16
0
19
50
2
26
1
3
8
17
14
2016
11
1
9
34
1
10
8
0
16
14
12
Total
38
1
33
98
3
37
11
3
25
31
27
Two Member States stated that they experienced difficulties in implementing the waiver
procedure. One DNA had difficulties with the languages in which the documents were
submitted and had to request translations, while the second found it difficult to identify
whether or not the documents provided were valid.
4.7.4 Validity of explicit consent (Article 14(8))
According to the procedure described in Article 14(6), explicit consent, once obtained, is
valid for three calendar years, after which it must be requested again, unless the terms
of the consent require otherwise. Export may continue for an additional 12 months after
the three-year period, however, pending a response to a new request for explicit
consent.
Fourteen Member States experienced cases where the export was allowed to proceed
pending a reply to a new request for explicit consent (see Table 19). The highest
number was reported by Germany, with 138 cases in total.
Table 19: Number of cases where the export was allowed to proceed pending a reply to a new
request for explicit consent, by Member State, during the reporting period
Member State
Austria
Belgium
Cyprus
Finland
France
Germany
Hungary
Italy
Netherlands
Poland
Slovenia
Spain
Sweden
United Kingdom
2014
0
0
0
0
0
1
0
0
0
0
0
0
0
0
2015
1
10
1
4
13
103
1
2
3
2
0
9
5
14
2016
1
1
0
6
5
34
2
2
11
0
1
17
7
18
Total
2
11
1
10
18
138
3
4
14
2
1
26
12
32
According to the Agency, Article 14(8) was initially difficult to implement due to
misunderstandings in its interpretation and a lack of understanding of the cases to which
it applied. The issue was then discussed at the 25
th
DNA meeting (on 21 April 2015) and
a common approach was identified. Once the way forward had been agreed, the related
functionality in ePIC was also modified in order to better support the implementation of
37
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this provision. Since then, although the provision remains challenging to implement, the
number of problem cases (i.e. in which the Agency and the DNAs disagree on the
interpretation) has been reduced to a very low level.
4.8 Information on transit movement (Article 16)
None of the Member States implemented Article 16 during the reporting period.
4.9 Requirements linked to exported chemicals and accompanying
information (Article 17)
Article 17 states that exported chemicals must be packaged and labelled in accordance
with the provisions on packaging and labelling in the CLP Regulation, the PPPR and the
BPR. The information on the label must also include the expiry date (for different climate
zones if necessary) and the production date. An SDS compliant with Annex II of the
REACH Regulation must be sent to each importer, together with the chemical. The
information on the label and the SDS should be given in the official languages, or in one
or more of the principal languages, of the country of destination or of the area of
intended use, insofar as possible.
The DNAs were asked to provide information on compliance issues observed during the
reporting period. Any such issues chiefly related to packaging requirements under the
CLP Regulation and the SDS.
Compliance issues relating to packaging and labelling requirements
The national enforcement authorities in eight Member States experienced compliance
issues concerning the information accompanying exported chemicals. Six Member States
indicated that they had identified compliance issues relating to the packaging
requirements of the CLP Regulation (see Figure 10).
Figure 10: Question 52. Were these compliance issues related to the application of packaging and
labelling requirements under PPPR, BPR, CLP or other regulations?
CLP
AT, CZ, FR, HU, IT, PT
Other
AT, BG, UK
BPR
AT, CZ, IT
PPPR
0
CZ, IT
1
2
3
4
5
6
7
8
Number of Member States
Compliance issues with the SDS and the language(s) of the label or SDS
Six Member States reported finding compliance issues relating to the application of SDS
requirements under the REACH Regulation.
Other compliance issues concerned the obligation to give information in one or more
official/principal languages of the country of destination, both on the label and on the
SDS (see Figure 11).
38
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Figure 11: Question 54. Were these compliance issues related to the obligation to give information:
on the label in one or more official/principal languages of the country of destination or on the SDS
in one or more official/principal languages of the country of destination?
On the label in one or more official/principal languages
of the country of destination
On the safety data sheets in one or more
official/principal languages of the country of destination
0
1
AT, CZ, FR, IT, PT, UK
AT, BG, FR, HU, PT
2
3
4
5
6
7
8
Number of Member States
Finally, two Member States reported experiencing compliance issues regarding the
information and packaging requirements linked to the exported products. Both indicated
that these compliance issues were related to the expiry date and the storage conditions
on the label.
4.10 Enforcement of Regulation (EU) No 649/2012 (Article 18)
According to Article 18 of the PIC Regulation, Member States must designate authorities
(such as customs authorities) to control the import and export of chemicals listed in
Annex I. The Commission, supported by the Agency, and the Member States must
coordinate their enforcement activities in respect of the PIC Regulation. The Forum for
Exchange of Information on Enforcement, established by the REACH Regulation, should
also be used to coordinate the network of authorities responsible for enforcement of the
PIC Regulation.
Article 18 states that Member States must provide information on the activities of their
enforcement authorities in their Article 22 reports. The questionnaire asked Member
States to report on: the organisation of enforcement activities at national level and their
enforcement strategy; training of inspectors; enforcement actions and their penalty
system; collaboration between National Enforcement Authorities (NEA) and DNAs and
Forum activities; and asked them to provide data on the enforcement activities and
infringements observed during the reporting period.
Information provided by the DNAs shows that all Member States have put in place a
system to ensure compliance with the PIC Regulation. All Member States have
nominated authorities responsible for the enforcement of the PIC Regulation (in most
Member States, this is the customs authority and the environmental/health
inspectorate). Many Member States have put in place some kind of enforcement
strategy (including rules of procedures, written instructions, etc.), and around half have
established regular training of inspectors. Most Member States have also described their
applicable penalty system. Twenty Member States reported having carried out controls
on exports or imports during the reporting period, 11 of which provided data on the
results of the controls, showing that few infringements were detected. Finally, DNA
feedback on the Forum activities was positive, with some welcoming the launch of a pilot
project dedicated to the PIC Regulation.
4.10.1 National enforcement authorities (NEAs)
Most Member States have several authorities in charge of enforcing the PIC Regulation.
Customs are involved in the implementation of the PIC Regulation in all Member States
39
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except Malta and the United Kingdom. In four countries, the customs administration is
the sole NEA (Spain, Croatia, Italy and Slovakia). Other enforcement authorities are
typically environmental, chemical and/or health inspection services. In nine Member
States, the NEA is part of the same institution as the DNA.
In almost all of the Member States in which NEAs are involved in the enforcement of the
PIC Regulation, they are also typically involved in the enforcement of the CLP Regulation
(27 Member States), the REACH Regulation (25 Member States), and the BPR (22
Member States).
The majority of Member States (18) indicated that NEAs have sufficient resources to
carry out their obligations under the PIC Regulation. Where Member States pointed to
insufficient resources in NEAs, they referred specifically to the lack of human resources.
4.10.2 Training inspectors
Fifteen Member States indicated that inspectors are regularly trained on the PIC
Regulation. Among the Member States that have organised regular training, eight stated
that such training is included as part of general training on chemicals legislation, while
four mentioned training specific to the PIC Regulation. Nine reported training specifically
targeting inspectors, while four mentioned training for customs officers.
Most Member States with no regular training on PIC explained that specific/regular
training was not needed during the reporting period, often because of training provided
by the Agency, national guidelines, and regular exchanges of information between the
DNAs and the NEAs. Only one Member State reported that training had not taken place
because of the lack of specialised trainers.
4.10.3 Enforcement strategy
Sixteen Member States reported having a strategy for the enforcement of the PIC
Regulation, of which 14 have already implemented that strategy (see Figure 12).
Figure 12: Question 62. Does your authority (or any other relevant authority) have an enforcement
strategy for Regulation (EU) No 649/2012?
HR, DK, EE, FI,
FR, EL, LV, LU,
MT, SI, ES, SE
AT, BE, BG, CY,
CZ, DE, HU, IE,
IT, LT, NL, PL,
PT, RO, SK, UK
Yes
No
40
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4.10.4 Enforcement activities
During the reporting period, 18 Member States carried out conformity checks and 15
carried out on-site visits in which the PIC Regulation was covered (see Figure 13).
Figure 13: Enforcement activities carried out in Member States
20
Conformity checks
AT, BE, BG, HR, CY, CZ, EE, FI, FR, DE, HU, IE, LT, NL, PL, PT, RO, SK
On-site visits
AT, BE, BG,CZ, EE, DE, HU, IE, LT, NL, PL, PT, RO, SI, SE
Others
DK, DE, EL, IT, LT, MT, NL, UK
Sampling
AT, EE, DE, IE, IT
No enforcement activities carried out
0
LV, LU, ES
2
4
6
8
10
12
14
16
18
20
Number of Member States
Eight Member States mentioned other enforcement activities (see Table 20):
Reactive operations/investigation of issues brought to the DNA’s attention;
Controls carried out as part of integral controls on compliance with REACH/CLP;
Cooperation with customs;
Risk-oriented random checks during custom clearance;
Conformity checks to assess whether or not a substance falls within the scope of
the PIC Regulation;
Document checks;
Checking reports submitted to the national database.
In 13 Member States, customs performed controls related to the PIC Regulation during
the reporting period, representing the largest number of controls in most countries.
NEAs performed controls on exports in 11 Member States. DNAs reported the following
data:
Table 20: Total number of official controls on exports in which the PIC Regulation was covered or
enforced during the reporting period, by Member State
Member State
Austria
21
Belgium
22
Customs
561
N/A
Inspectors
16
29
Others
N/A
N/A
20
Luxembourg and Latvia ticked ‘other’, indicating that no enforcement activities were carried out (as no
exports took place during the reporting period).
Available data from the inspectors cover only parts of the inspection activities, as export control is not
separated from general controls; consistent statistics on export-related enforcement activities of NEAs will
be available from 2017 onwards (implementation of a new Reporting scheme).
Information missing (N/A) as the cooperation agreement between the DNA and the customs is not yet in
force.
21
22
41
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Member State
Bulgaria
Croatia
Cyprus
Czech Republic
Denmark
Estonia
Finland
23
France
Germany
24
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Luxembourg
Malta
Netherlands
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Customs
463
N/A
3
N/A
N/A
1
3633
123
1
N/A
35
43
401
0
0
0
0
275
N/A
135
0
0
0
0
N/A
0
Inspectors
0
0
1
N/A
0
0
1
N/A
29
N/A
30
N/A
N/A
0
1
0
0
661
0
1
0
0
9
0
0
1
Others
N/A
N/A
0
N/A
N/A
0
N/A
N/A
0
17
25
N/A
N/A
N/A
0
0
0
4
0
N/A
N/A
0
0
0
0
N/A
0
In four Member States, customs carried out controls on imports during the reporting
period. NEAs reported performing controls on imports in nine Member States. DNAs
reported the data contained in Table 21.
Table 21: Total number of official controls on imports in which the PIC Regulation was covered or
enforced during the reporting period, by Member State
26
Member State
Austria
Belgium
Bulgaria
Croatia
Cyprus
27
Czech Republic
Denmark
Estonia
Finland
Customs
0
N/A
0
N/A
N/A
N/A
N/A
6
N/A
Inspectors
0
N/A
40
0
0
N/A
0
8
0
23
For Year 1, figures from the customs authority cover the whole year 2014
including the period before the
entry into force of the new PIC Regulation.
No statistics or records are kept by the customs authorities in Germany.
The category ‘other’ includes conformity checks to assess whether a substance falls within the scope of PIC
regulation or not.
Member States
could report other types of controls in the column ‘other’, although none did.
The DNA indicated that data for customs were not available.
24
25
26
27
42
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Member State
France
Germany
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Luxembourg
Malta
Netherlands
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Customs
N/A
0
N/A
N/A
43
804
0
0
0
0
0
N/A
248
0
0
0
0
N/A
0
Inspectors
N/A
20
N/A
63
N/A
N/A
0
1
0
0
661
7
24
16
0
0
0
0
0
4.10.5 Enforcement actions and penalty systems
Member States were asked to describe the measures that enforcement authorities can
take to ensure compliance with the PIC Regulation, and their penalty system in case of
infringement. DNAs typically described a mix of enforcement measures, such as seizure
and detention of goods, withdrawal from the market, suspension of activities etc. Ten
Member States stated that NEAs could issue letters of formal notice to request
compliance within a certain timeframe. On penalties for infringements, 23 Member
States indicated that they impose fines for specific infringements, often with a scale of
fines depending of the gravity of the infringement. In seven Member States, a penalty of
imprisonment can be imposed on the most serious infringements.
4.10.6 Infringements during the reporting period
Infringements found through customs controls
Three Member States reported identifying infringements through customs controls
(Germany, France and Italy) (see Table 22). The number of infringements is very low
compared to the number of customs controls performed
28
. Germany indicated that the
infringement found by customs concerned a chemical that did not conform to the export
notification.
Table 22: Number of customs controls and infringements observed during the reporting period
Member State
France
Germany
Italy
Controls on exports
123
1
401
Controls on imports
N/A
0
804
Infringements found
3
1
9
28
Germany reported one infringement for one control but specified that records of customs controls were not
kept.
43
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Infringements found through inspectors’ controls
Nine Member States found infringements through controls carried out by inspectors
(Table 23). As there might be overlaps between the numbers of controls performed on
exports and imports, it was deemed better not to calculate shares of infringements.
However, it should be noted that the number of infringements compared to the number
of controls varies greatly across the nine Member States. One reason for this variation
might be that different types of controls were performed. For example, the UK DNA
explained that reactive controls were performed, which might explain the low number of
controls and the high probability of detection of an infringement.
Table 23: Numbers of controls carried out by inspectors and infringements observed during the
reporting period
Member State
Austria
Belgium
Bulgaria
Finland
Germany
Hungary
Lithuania
Netherlands
United Kingdom
Controls on exports
16
29
0
1
29
30
1
29
661
30
1
Controls on imports
0
N/A
40
0
20
63
1
661
0
Infringements found
8
10
7
1
21
2
1
2
1
The main category of infringement found through inspections was non-conformity of the
chemical with the export notification. Infringements relating to SDS and labelling
requirements were also found (see Table 24).
Table 24: Types of infringements of the PIC Regulation observed by inspectors during the reporting
period
Member State
Labelling
requirements
Safety data
sheets
Expiry date
of
the
chemical
Chemical not in
conformity
with
export notification
Other
Austria
Belgium
Bulgaria
Finland
Germany
Hungary
Lithuania
Netherlands
United Kingdom
4
0
0
0
0
1
0
0
0
3
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
1
10
0
0
18
2
1
2
1
0
N/A
0
1
0
2
1
0
0
The four infringements reported as ‘other’ concerned: omitting to report imports
(Finland); missing the reporting obligations under Article 10 (Hungary) and exporting
without export notification (Lithuania).
Of the infringements reported in ‘other’, none
were through the controls reported in the
category ‘other’ (i.e. made by neither customs nor inspectors).
29
Lithuania reported that one exporter was identified as exporting without notification and controlled. Although
one control is reported for exports and one for imports, it is the same control.
As the Netherlands reported the exact same number of controls by inspectors for exports and imports in 2014,
2015, and 2016, it can be assumed that both exports and imports were checked during the same controls.
30
44
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Penalties
Thirteen infringements led to penalties in four Member States. In Lithuania, the
Netherlands and Austria, all infringements led to penalties, while only a small
percentage of infringements (10%) resulted in a penalty in Germany (see Table 25).
Table 25: Number of infringements that led to penalties during the reporting period
Member State
Austria
Germany
Lithuania
Netherlands
Number of infringements
8
2
1
2
4.10.7 Collaboration between DNAs and NEAs
Collaboration between DNAs and NEAs
Twenty-three Member States reported regular exchanges of information between the
DNA(s) and enforcement authorities. Six Member States stated that, as the DNA and the
NEA are in the same institution, the exchange of information occurs on a daily basis, as
necessary. Six other Member States indicated that regular meetings were held between
DNAs and NEAs to exchange information, while a further eight mentioned regular
exchange of information by email through contact points, or following procedures
provided for in laws, agreements or guidelines, or through annual inspection reports
sent to the DNA.
Few Member States described the types of information exchanged: cases of exports and
imports and exporting/importing companies (four Member States), interpretation and
scope of the PIC Regulation (two Member States), updates and changes in the PIC
Regulation (one Member State).
Eleven Member States made suggestions to improve collaboration between the DNAs
and enforcement authorities. Some also mentioned the following exchanges of
information between authorities at national level:
Enhance information exchange / updates between the DNA and enforcement
authorities, including customs;
Organise face-to-face meeting at least once a month;
Organise training courses on PIC issues for all enforcement authorities;
Keep information available on DNA and NEA websites up to date with legal
changes.
Other comments related to actions to be taken at EU level:
Exchange of best practices between Member States with a lot of experience in
PIC controls and those with quite limited numbers of exports subject to PIC
Regulation provisions;
Make the PIC procedure more visible in the Forum;
Improve cooperation and coordination by DG ENV with DG TAXUD;
Fully implement the Single Window System, to control all customs declarations
that have indicated a RIN code, not only the customs declaration physically or
controlled by documentation;
Ensure specific CN codes are used, as these are easier to control than products
with generic CN codes.
Collaboration between DNAs and national members of the Forum for Exchange
of Information on Enforcement
Twenty-three Member States reported regular exchange of information between the
DNAs and the national member(s) of the Forum.
45
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Of those Member States reporting close collaboration, seven explained that regular
exchanges of information occur without formal communication or coordination
mechanisms, as the Forum member is also a member of the DNA or is part of the same
31
institution . Other Member States indicated regular exchange of information, either
through written/electronic communication channels or through regular meetings
between institutions on outcomes of DNA and Forum meetings and activities of the
Forum related to PIC (e.g. pilot projects, guidance development).
Nearly all Member States (26) indicated their satisfaction with the collaboration with the
national Forum members.
Five Member States provided suggestions for improving collaboration between DNAs and
Forum members:
Inform DNAs about any Forum activities concerning the PIC Regulation, provide
DNAs with direct access to Forum documents, or give DNAs the option to
participate in Forum meetings;
The Forum Secretariat at the Agency, which also reports to the DNA meetings,
should inform Forum members in advance, so that they can contact their DNA(s)
about issues in enforcement;
Invite Forum members involved in PIC activities to attend PIC DNA meetings;
Increase communication between DNAs and Forum members.
One DNA added that the planned PIC pilot enforcement project presents a good
opportunity to enhance collaboration between DNAs, Forum members, NEAs and
customs.
4.10.8 Forum activities
The Forum did not engage in any regular exchange of information on the PIC Regulation
during the reporting period, but such exchange is part of the Forum’s Multiannual Work
Programme. In 2016, the Forum decided to run a pilot project on PIC enforcement,
focusing on export notifications. The preparation and execution of this project will take
place in the next reporting period. The Forum has also defined the specifications for the
PIC form in the ICSMS tool (Commission-owned IT platform for exchange of information
in a secure way between NEAs).
Although Forum activities on PIC are just beginning, 19 Member States indicated their
satisfaction with the activities carried out by the Forum.
Eight Member States suggested improvements to the activities of the Forum in respect
of the PIC Regulation:
Five Member States pointed to the need to carry out enforcement projects or
pilot projects related to the PIC Regulation;
One Member State suggested adding the PIC Regulation to the general controls
on REACH, CLP, POPs, mercury;
One Member State underlined the importance of keeping the PIC best practice
document up-to-date;
One DNA suggested increasing the possibilities for sharing experiences between
Member States;
One Member State suggested that DNA experts should be invited to Forum
meetings for discussions on activities relating to PIC Regulation.
According to the Agency, careful prioritisation of PIC activities is essential, given the
limited resources of the Forum, and the many priority areas for coordinated
31
One Member State provided the same justification for replying ‘no’.
46
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enforcement. One potential improvement would be to increase the number of PIC-
related activities, including integration into enforcement projects relating to other
legislation.
4.11 Exchange of information (Article 20)
According to Article 20, the Commission, assisted by the Agency, and the Member
States must facilitate the provision of scientific, technical, economic and legal
information to other countries on chemicals subject to the PIC Regulation, including
toxicological, ecotoxicological and safety information. Every two years, the Agency must
compile all of the relevant information that has been transmitted.
Information provided following ad-hoc requests
The Commission provided an answer to two requests from third countries in 2014-
2015
32
:
One from Peru, asking whether or not three particular mixtures were subject to
an export notification under the EU PIC Regulation.
One from Serbia, requesting clarifications of the provisions on mercury with
respect to Regulation (EU) No 649/2012 and Regulation (EC) No 1102/2008.
The Commission replied to four requests in 2016 from four countries (Canada,
Indonesia, Lebanon and Syrian Arab Republic) concerning four chemicals. In addition,
information was sent to Ecuador in response to a request.
The Agency did not receive any requests within the scope of Article 20 in either 2014 or
2015. It received two requests in 2016, from the authorities in the Syrian Arab Republic
and China, respectively.
EU Member States did not receive any ad-hoc requests for information during the
reporting period.
Reporting on the information transmitted
The Agency published its first compilation of transmitted information in November
2016
33
, covering the first two years of implementation of the PIC Regulation (2014-
2015). The report addresses information submitted by means of export notifications,
FRA notifications, and following ad-hoc requests. The next Article 20 report will cover
the 2016-2017 period.
The Agency did not experience difficulties in collecting the information from the
Commission and the Member States on the data transmitted. The only challenge it
reported was in clarifying the scope of the report with the Commission and Member
States, as it was the first of its kind. The scope of the report was clarified between the
Commission and the Agency and discussed with the DNAs at the 27th DNA Meeting (held
on 26 April 2016). The Agency shared the lessons learned from this reporting exercise at
the 28
th
DNA meeting (14 December 2016) in order to achieve more clarity for the next
reporting period.
32
ECHA,
Overview on the exchange of information under Article 20 of the PIC Regulation - Compilation of the
information collected by the European Commission, assisted by the Member States and the European
Chemicals Agency (ECHA),
2016, available at:
https://echa.europa.eu/documents/10162/21728206/pic_article_20_report_2014-2015_en.pdf/ad0e2b0d-
4f12-486f-b1da-9fd2ddbbb187
Idem.
33
47
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4.12 Technical assistance (Article 21)
Under Article 21, the Commission, DNAs and the Agency must cooperate in promoting
technical assistance, in particular to help developing countries and countries with
economies in transition to implement the Convention and to develop the infrastructure,
capacity and expertise necessary to manage chemicals properly throughout their
lifecycles. In addition, the Commission and DNAs must actively participate in
international activities in capacity-building in chemicals management, and consider
giving support to NGOs.
The Agency and DNAs were asked to describe the activities in which they participated.
The Agency mainly participated in activities intended to explain the specific provisions of
the PIC Regulation and the differences with the provisions of the Convention. DNA
activities, by contrast, consisted of the provision of technical expertise or technical
information through training workshops, visits, twinning projects, etc.
Cooperation with developing countries, countries with economies in transition
and NGOs
During the reporting period, the Agency was involved in the following cooperation
activities:
2015 workshop organised by the Rotterdam Convention Secretariat to strengthen
cooperation on the implementation of the Convention between the DNAs of
Burundi, Cameroon, Congo, Djibouti, Gabon and Rwanda. The aim was to clarify
the provisions of the Rotterdam Convention and highlight the differences with the
EU PIC Regulation.
2016 workshop organised by the Rotterdam Convention Secretariat to strengthen
cooperation on the implementation of the Convention between the DNAs of
Benin, Burkina Faso, Cabo Verde, Ivory Coast, Gambia, Guinea, Guinea
Bissau,
Mali, Mauritania, Niger, Senegal, Chad and Togo. Although the Agency cancelled
its participation, it had already contributed to preparing the training materials,
presentations, etc.
Five Member States participated in cooperation activities, mostly relating to the
provision of technical information and technical expertise in the preparation of FRA
notifications to the Secretariat (see Figure 14).
Figure 14: Question 56. What types of cooperation have you been involved in?
Technical information
Technical expertise for the preparation of
notifications to the Secretariat
Promotion of the exchange of experts
Other
Technical expertise for the identification of
hazardous pesticides formulations
Support for the establishment or maintenance of
DNAs
0
SE
SE
1
BE, BG, DE, SE
BE, BG, SI
BG, SI, SE
AT, DE
2
3
4
5
Number of Member States
48
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Three DNAs mentioned other types of cooperation:
Participation in sub-regional workshops organised by the Secretariat of the
Convention (Yaoundé, 16-19 November 2015 and Dakar, 28 November-1
December 2016), mentioned above by the Agency (Belgium);
Expert assistance in setting up the international dimension of the Georgian
Ministry of Environment’s Waste and Chemicals Management Department
and
Legal Department, in particular on the development of national legislation and
training staff on the implementation and enforcement of the Rotterdam
Convention and the EU PIC Regulation within a twinning project on Waste
Management in Georgia GE/10/ENP-PCA/EN06, 2012-2014 (Bulgaria);
Visits of an expert delegation to the Member States’ institutions (visit of the
Federal Institute for Operational Safety and Health in Dortmund) (Germany).
Capacity-building activities
The Agency organised or participated in capacity-building activities on the sound
management of chemicals. These targeted EU candidate countries and potential
candidates for EU accession, with a view to supporting them at a technical level to align
with the REACH, CLP, BRP and PIC Regulations. These activities took place under the EU
Instrument for Pre-accession assistance (IPA), the European Neighbourhood and
Partnership Instrument (ENPI), the Technical Assistance and Information Exchange
instrument (TAIEX) and twinning projects. PIC-related issues were also put on the
agenda of third country visits to
the Agency’s premises.
The Agency provided some examples of capacity-building activities:
2014 workshop on PIC and ePIC for EU candidate countries and potential
candidates;
3-day visit of a delegation from Turkey to
the Agency’s premises, to
provide an
overview of the Rotterdam Convention and the EU PIC Regulation;
Participation in PIC and ePIC training organised by a technical assistance project
for Turkey;
Bilateral discussions with 47 non-EU countries at the margins of the 7th
Conference of the Parties to the Rotterdam Convention to clarify the specific
provisions of the PIC Regulation, discuss problem cases and gather feedback
from the authorities in the non-EU countries.
Six Member States participated in projects or international activities relating to capacity-
building in chemicals management during the reporting period:
Twinning project on Waste Management in Georgia (Bulgaria, see above);
Activities related to the Minamata Convention and SAICM (France);
Visit of the Federal Institute for Operational Safety and Health in Dortmund
(Germany, see above);
A TAIEX project in Turkey (Italy);
Twinning Project (2015–2017) on the Further Development of Chemicals and
Biocides Products Management in the Republic of Serbia (Slovenia);
International training courses financed by the Swedish International Development
Cooperation Agency, regional meetings and working sessions focussing on
capacity-building and other aspects of the sound management of chemicals in
Southeast Asian countries, Southern African Development Community countries,
Brazil, Indonesia, China and Serbia (Sweden).
4.13 IT-related aspects
Under Regulation (EU) No 649/2012, the Agency developed and continues to maintain
the IT tool ePIC to support the implementation of the PIC Regulation, in particular the
exchange of information between industry users, i.e. exporters, and authorities. ePIC
was launched in September 2014, shortly after the entry into force of Regulation (EU)
49
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No 649/2012 and replaced the previous EDEXIM database. It consists of three
interfaces, one for industry users, one for authority users (DNAs, the Commission, the
Agency and enforcement authorities) and one for customs officers.
For the purposes of this reporting exercise, the Agency was asked to provide information
on the operation and use of ePIC and the data made publicly available on its website.
Member States were asked to provide information on the use of ePIC data at national
level and their experiences in using ePIC.
Overall, the DNAs assessed ePIC as user-friendly and reported no major issues in using
it. Feedback from industry users to the Agency and DNAs was also generally positive, as
was the feedback from customs and enforcement authorities received by DNAs. The
Agency identified some improvement needs for ePIC that will be implemented in the
next reporting period, some of which are based on user feedback. All of the data that
should have been made publicly available by the Agency according to the Regulation,
were indeed made available online during the reporting period.
4.13.1 The ePIC system
During the reporting period, a total of 2,352 authority and industry users used ePIC (see
Table 26).
Table 26: Number of ePIC users during the reporting period
34
Industry
DNAs
Commission
NEAs
Number of users
1,836
127
1
388
As there is no user management for the customs application, the Agency could only
provide estimates for the use of the customs interface:
26 Member States consulted the application;
One Member State checked over 2,500 individual notifications;
One Member State checked approximately 600 individual notifications;
Five Member States checked between 100-350 individual notifications;
Seven Member States checked between 40-100 individual notifications;
12 Member States checked fewer than 20 individual notifications.
The following new features were added to the ePIC system during the reporting period:
Management of Article 10 report through ePIC: submission of Article 10 report by
exporters and importers; checking of reports by DNAs; aggregation of national
reports by DNAs and submission to the Agency; compilation of Member State
data by the Agency.
Enhanced explicit consent metadata, with the new ‘RIN match algorithm’
functionality.
Waiver management.
Bulk special RIN submissions available to industry.
Automated sending of all email communication for export notifications, including
cover notes, second sending of export notifications after 30 days (in the absence
of an acknowledgement of receipt) and explicit consent reminders.
Pre-filled explicit consent request forms for DNAs.
Possibility for the Agency users to add/edit PIC chemicals.
34
Regarding DNA and NEA accounts: the numbers provided in the table refer to the existing number of
accounts created and tokens issued for ePIC. They do not necessarily
refer to ‘active users’ of ePIC.
50
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Implementation of fully-fledged workflows with associated task items and
deadlines.
Event history, submission history and message history available, allowing
traceability for audit purposes and for everyday follow-up of tasks/actions.
Message box embedded in task items.
Enhanced security of the application.
According to the Agency, these new features reduced processing time, increased
efficiency, enabled traceability and contributed to ensuring consistency and reliability of
the data in the system. They also enabled all stakeholders (industry, DNAs, the
Commission and the Agency itself) to manage an increasing number of tasks and meet
legal deadlines without significantly increasing their staff numbers.
4.13.2 User-friendliness of the ePIC system
DNAs
According to the Agency, the feedback received from the DNAs was generally positive.
Many of their suggestions for improvement were implemented during the reporting
period.
In their reporting questionnaires, the DNAs were also generally positive about the user-
friendliness of ePIC in carrying out their main obligations under the PIC Regulation. The
only area where several Member States reported difficulties was the Article 10 reporting
(see Figure 15).
Figure 15: Question 79. Is the ePIC system easy to use for DNAs?
When dealing with export notifications (Article 8)
When dealing with requests for explicit consent
(Article 14)
When dealing with special RIN requests (Article
19(2))
When dealing with waivers (Article 14 (6) and (7))
When dealing with reporting pursuant to Article 10
When dealing with other PIC procedures
0
5
10
15
20
25
30
Number of Member States
Yes
No
No experience
Exporters and importers
Similarly, the Agency received generally positive feedback from industry users, with
stakeholder surveys indicating that 87% of industry users in 2015 and 96.7% in 2016
were satisfied with ePIC. The simplicity of the application and the pre-filled data were
reported as being particularly valuable.
The feedback received by DNAs from industry users was also generally positive,
although it should be noted that only around half of the Member States replied to this
51
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question (see Figure 16). Levels of satisfaction with ePIC are slightly lower for export
notifications and Article 10 reporting.
Figure 16: Question 80. Where possible, please provide feedback from exporters on the user-
friendliness of the ePIC system.
General user-friendliness
Export notifications
Special RIN requests
Waivers
Article 10 Reporting
Management of mixtures/articles via ePIC
0
5
10
15
20
25
30
Number of Member States
Easy to use
Not easy to use
No Answer
One DNA mentioned that companies judged the ePIC User Manual too lengthy and
detailed, and suggested that it would be useful to create user-friendly factsheets, or
short guidance, such as those that exist for REACH. Another DNA recommended that
guidance and tools should be provided in national languages.
One DNA stated that exporters would find the export notification process more user-
friendly if they could communicate directly with the Agency to understand, for instance,
why a notification is rejected or pending resubmission. It pointed out that the exporter
does not receive the importing country’s answer in cases where it does not give explicit
consent or rejects the export notification, creating problems for companies who do not
know why consent has not been given, or how they might amend their notification or
assist their clients in the importing country with their approach to their own authorities.
The same DNA also mentioned that exporters would find it helpful to have the Active
RIN Period in the overview.
On Article 10 reporting, one DNA stated that exporters would find it easier to submit a
single report containing all of the information rather than having to enter different
information (amount, country, etc.) separately.
For enforcement authorities
19 Member States reported that their customs authorities used ePIC, the majority of
whom (12) stated their belief that customs found ePIC easy to use and adequate to
support their work.
As national enforcement authorities other than customs have only had access to ePIC
since the second quarter of 2016, the Agency has not yet received any relevant
feedback. Six Member States, however, indicated that their enforcement authorities
used ePIC and considered it easy to use and adequate to support their work.
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4.13.3 Areas of improvement
The Agency identified the following improvement needs for ePIC with a view to reducing
processing times, reducing the occurrence of clerical errors, increasing compliance with
legal obligations, and providing for a better user experience overall:
Include the generation of non-confidential Article 10 reports in ePIC;
Improve the RIN match algorithms;
Improve the management of the chemicals database to make the chemicals
easier to search and edit, simplify the insertion of new amendments, make the
breakdown of group entries more transparent to companies, and facilitate data
dissemination;
Improve usability for exporters by improving data validation checks,
standardising alerts and error messages, improving the document upload
functionality and related options;
Further refine search options to facilitate navigation through the increased
volume of data in the system;
Improve internal messaging to ensure that as much communication as possible
can happen within the system, for traceability and audit purposes;
Enhance the Agency’s back-office
functionality to reduce the number of manual
tasks or tasks which require database changes.
4.13.4 Data dissemination
According to the PIC Regulation, the Agency should make the following data publicly
available:
The list of chemicals included in Annex I (Article 7);
The updated list of chemicals subject to export notification, and the importing
Parties and other countries for each calendar year (Article 8);
Reports on actual quantities of chemicals subject to the PIC Regulation exported
and imported (Article 10);
Import decisions (Article 13);
Non-confidential data on explicit consents received from non-EU countries (Article
14).
The Agency has a specific webpage dedicated to the PIC Regulation, where the content
of the legislation and the different procedures are explained. The webpage also contains:
A link to the legal text and its amendments
35
;
Article 10 reports on actual quantities of chemicals exported and imported
36
;
Article 20 reports on information exchange, published for the first time in
November 2016
37
.
According to the Agency, the approach to Article 10 reporting, in particular the
calculation and presentation of data, has been significantly revised compared to previous
years. The new approach enables the disclosure of more data while respecting the
Eurostat recommendations on data confidentiality. The data are presented in two levels
of aggregation, one focused on the exported chemical(s) and the other on the countries
of export and destination.
As required by the PIC Regulation, the Agency has also set up a database containing:
35
36
PIC legislation:
https://echa.europa.eu/regulations/prior-informed-consent/legislation
Annual reporting on PIC exports and imports:
https://echa.europa.eu/regulations/prior-informed-
consent/annual-reporting-on-pic-exports-and-imports
Reporting on information exchange:
https://echa.europa.eu/regulations/prior-informed-consent-
regulation/reporting-on-information-exchange
37
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The list of chemicals subject to the PIC Regulation
38
;
High-level information and statistics on export notifications
39
;
High-level information and statistics on import notifications
40
;
Non-confidential data on explicit consents received from non-EU countries
41
;
EU and non-EU DNA contact details
42
.
In addition, information on substances subject to the PIC Regulation is also made
available through the Agency’’s
webpages ‘Information on chemicals’, which provide an
infocard for each substance, and, for others, a more detailed profile.
Feedback received by the Agency on the publicly available data from authorities in non-
EU countries was positive. In particular, those authorities found it useful to have
summaries of export notifications and explicit consents for their countries. Feedback
from companies and trade associations was more mixed. A small number of companies,
together with one of the main industry trade associations, highlighted that the chemicals
subject to the PIC Regulation (especially the breakdown of group entries) is not always
clear on the website and could be improved. The Agency has noted this request for
improvement and will consider it at a later stage.
38
39
40
41
42
Chemicals subject to PIC:
https://echa.europa.eu/information-on-chemicals/pic/chemicals
Export notifications:
https://echa.europa.eu/information-on-chemicals/pic/export-notifications
Import notifications: https://echa.europa.eu/information-on-chemicals/pic/import-notifications
Explicit consents: https://echa.europa.eu/information-on-chemicals/pic/explicit-consents
DNAs:
https://echa.europa.eu/information-on-chemicals/pic/designated-national-authority
54
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Annex
Report of the European
Commission on the
Operation of the PIC
Regulation (EU) No 649/2012
55
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Contents
1.
2.
INTRODUCTION ................................................................................................... 59
INTERNAL WORK OF THE COMMISSION .................................................................. 60
2.1.
Internal organisation and resources .............................................................. 60
2.1.1.
2.1.2.
2.1.3.
2.1.4.
2.2.
2.2.1.
2.2.2.
2.2.3.
2.2.4.
2.3.
2.3.1.
2.3.2.
3.
Resources ..................................................................................... 60
The Agency’s
budget
...................................................................... 60
Coordination between the Commission and the Agency....................... 61
Coordination between the Commission and DNAs ............................... 61
Amendments of Annexes I and V to the PIC Regulation ...................... 61
Union import decisions ................................................................... 63
Guidance to Member States on the legal interpretation of the PIC
Regulation .................................................................................... 64
Adoption of a format for reporting on the implementation of PIC ......... 65
Emergency situations (Article 8(5)) and waivers (Article 14(7)) ........... 66
Enforcement of the PIC Regulation ................................................... 66
Policy work ................................................................................................ 61
Implementation and enforcement of the PIC Regulation .................................. 66
INTERNATIONAL WORK OF THE COMMISSION ......................................................... 66
3.1.
3.2.
3.3.
3.4.
Preparation, coordination and submission of EU input to the Secretariat, the
COP, the CRC and other subsidiary bodies ..................................................... 67
Communication of information to the Secretariat of the Rotterdam Convention... 68
Financial contribution to the Rotterdam Convention ........................................ 68
Exchange of information (Article 20) ............................................................. 69
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Abbreviations used
BPR
CAS
CoP
DDT
DNA
ECHA
PIC
POPs
PPPR
REACH
Biocidal Products Regulation
Chemical Abstracts Service
Conference of the Parties to the Rotterdam Convention
Dichlorodiphenyltrichloroethane
Designated National Authority
European Chemicals Agency
Prior Informed Consent
Persistent Organic Pollutants
Plant Protection Products Regulation
Registration, Evaluation, Authorisation and Restriction
Regulation
of
Chemicals
57
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1. Introduction
Article 22 of Regulation (EU) No 649/201243
(‘PIC Regulation’) requires
the Commission
to report on its activities under the Regulation every three years and to compile a
synthesis report on the performance of the PIC Regulation, integrating:
The information submitted by Member States as per Article 22(1) concerning the
operation of the procedures provided for in this Regulation, including customs
controls, infringements, penalties and remedial actions.
The information submitted by the European Chemicals Agency (ECHA) as per
Article 22(1) concerning the operation of the PIC
Regulation’s procedures.
This reporting exercise is the first under the new PIC Regulation. It covers the three
years of implementation since the Regulation entered into force in 2014 (2014-2016). A
common reporting format for Designated National Authorities (DNAs) was established by
Commission Implementing Decision (EU) 2016/770 of 14 April 2016
44
, in order to collect
consistent information across Member States. A reporting format for the Agency’s report
was adopted through Commission Implementing Decision (EU) 2016/1115 of 7 July
2016
45
.
The present report is the Commission report on the performance of the functions for
which it is responsible under the PIC Regulation, for the period 2014-2016. As per
Article 22(2), it is incorporated in the synthesis report on the operation of the
procedures during the period 2014-2016 provided for in Regulation (EU) No 649/2012,
together with the information submitted by the Member States and the Agency.
In drafting this report, relevant information was compiled from EUR-lex, the website of
the Rotterdam Convention, and documents published on CIRCABC, including minutes of
meetings, and other documents discussed at DNA meetings. The sources used for this
report are listed in Table 1.
This report is divided into two sections, the
Commission, and the second addressing the
the EU DNA, coordinator of input provided
representative of the EU under the Rotterdam
Table 1 : List of relevant documents consulted
first addressing the internal work of the
international work of the Commission, as
by the EU and its Member States, and
Convention.
List of relevant documents consulted
Implementing and delegated acts
Commission Delegated Regulation (EU) No 1078/2014 amending Annex I to the PIC
Regulation.
Commission Delegated Regulation (EU) 2015/2229 amending Annex I to the PIC
43
Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the
export and import of hazardous chemicals, OJ L 201, 27.7.2012, pp. 60–106.
Commission Implementing Decision (EU) 2016/770 of 14 April 2016 establishing a common format for the
submission of information concerning the operation of the procedures pursuant to Regulation (EU) No
649/2012 of the European Parliament and of the Council concerning the export and import of hazardous
chemicals, C/2016/2068, OJ L 127, 18.5.2016, pp. 32–51.
Commission Implementing Decision (EU) 2016/1115 of 7 July 2016 establishing a format for the submission
by the European Chemicals Agency of information concerning the operation of the procedures pursuant to
Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and
import of hazardous chemicals, C/2016/4141, OJ L 186, 9.7.2016, pp. 13–23.
44
45
58
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List of relevant documents consulted
Regulation.
Commission Implementing Decision of 11 February 2016 adopting Union import decisions
(2016/C 61/06).
Commission Implementing Decision of 15 May 2014 adopting Union import decisions
(2014/C 152/02).
Commission Implementing Decision of 14 April 2016 establishing a common format for the
submission of information concerning the operation of the procedures pursuant to
Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning
the export and import of hazardous chemicals.
Commission Implementing Decision of 7 July 2016 establishing a format for the
submission by the European Chemicals Agency of information concerning the operation of
the procedures pursuant to Regulation (EU) No 649/2012 of the European Parliament and
of the Council concerning the export and import of hazardous chemicals.
DNA meeting documents
Minutes of 23
rd
, 24
th
, 25
th
, 26
th
, 27
th
and 28
th
DNA meetings.
Amendments to Annex I to Regulation (EU) No 649/2012, presented at 23
rd
, 24
th
, 25
th
,
26
th
, 27
th
and 28
th
DNA meetings.
Import decisions presented at 23
rd
, 24
th
, and 26
th
DNA meetings.
Submission of notifications to the PIC Secretariat, presented at 23
rd
, 24
th
, 25
th
, 26
th
, 27
th
and 28
th
DNA meetings.
Implementation issues presented at 23
rd
, 24
th
, 25
th
, 26
th
, 27
th
and 28
th
DNA meetings.
Documents on the preparation of COP 7 and 8, presented at 25
th
, 26
th
and 28
th
DNA
meetings.
Rotterdam Convention’s documents
PIC circulars published by the Rotterdam Convention.
2. Internal work of the Commission
2.1. Internal organisation and resources
2.1.1. Resources
DG Environment is in charge of the PIC Regulation. Unit B.2
sustainable chemicals has
one policy coordinator responsible for carrying out the Commission’s administrative
functions under PIC. The policy coordinator is supported by a lawyer for legal questions
and by a secretary for all organisational work. For international work, Unit B.2 has one
expert (the policy coordinator) nominated to the Convention bodies, i.e. the CRC and
the intersessional working group on the process of listing chemicals in Annex III to the
Convention. In addition, colleagues of Unit F.3, responsible for multilateral
environmental cooperation, contribute to the international work, in particular in the
context of the Conference of the Parties (CoP), by dealing with horizontal and cross-
cutting matters, such as financial resources, budget, technical assistance and some legal
matters. The staff resources occupied by this work amount to 0.4 FTE for the policy
coordinator and 0.4 FTE for the supporting work, including international matters.
2.1.2.
The Agency’s budget
According to Article 24, the budget of the Agency for the operation of the PIC Regulation
consists of a subsidy granted by the EU for the purposes of this Regulation. The subsidy
for the period 2014-2016 was set by the Commission as part of its Multiannual Financial
Framework 2014-2020.
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2.1.3. Coordination between the Commission and the Agency
The Commission and the Agency cooperate closely in the implementation of Regulation
(EU) No 649/2012. There are regular exchanges on scientific, technical and legal
questions arising in the context of implementation, in particular the legal interpretation
of provisions and their practical implementation. The Agency participates in all PIC DNA
meetings and reports on the work done in the area of implementation, including the
operation of the IT application (ePIC) and the work of the Forum on the Exchange of
Information on Enforcement. The Commission contributed to the development of the
guidance produced by the Agency and also to the work of the Forum on Exchange of
Information on Enforcement.
For cooperation with third countries and the Secretariat of the Rotterdam Convention,
the Commission and the Agency closely coordinate their activities to ensure that the
most appropriate and effective assistance is provided, and that resources are used
efficiently.
2.1.4. Coordination between the Commission and DNAs
The Commission and the DNAs of the Member States closely cooperate in the
implementation of Regulation (EU) No 649/2012. There are regular exchanges on
scientific, technical and legal questions arising in the context of implementation, in
particular through discussions at the twice-yearly PIC DNA meetings. If necessary, and
where appropriate, the Commission consults DNAs in writing on specific questions. At
the same time, individual DNAs consult the Commission on specific questions of
interpretation and implementation of the Regulation.
The Commission coordinates and consults with DNAs on any submissions to the
Secretariat of the Rotterdam Convention. On cooperation with third countries, the
Commission and DNAs coordinate some of their activities to ensure coherence of the
assistance provided and efficient use of resources.
2.2. Policy work
2.2.1. Amendments of Annexes I and V to the PIC Regulation
Annexes to the PIC Regulation are amended through delegated acts, adopted by the
Commission, in accordance with Articles 23 and 26 of Regulation (EU) No 649/2012. The
procedure for adoption of delegated acts requires the Commission to consult experts on
draft amendments. As the Commission explained in the 23
rd
and subsequent DNA
meetings, this consultation is carried out by presenting the drafts at the DNA meetings
in order to ensure that all Member State experts, as well as observers, have the
opportunity to comment. Delegated acts are also scrutinised by the European Parliament
and the Council to ensure that the Commission does not exceed its powers.
Amendments to Annex I
Proposed amendments to Parts 1 and 2 of Annex I are triggered by regulatory actions
changing the legal status of a substance under other relevant EU legislation, in
particular:
Decision not to approve or to withdraw an active substance under the PPPR.
Decision not to approve or to withdraw an active substance under the BPR.
Decision to subject a chemical to authorisation by adding it to the Authorisation
List (Annex XIV) of the REACH Regulation.
Decision to restrict the use of a chemical (Annex XVII) under the REACH
Regulation.
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During the reporting period, two Delegated Regulations amending Annex I were
adopted, in 2014 and 2015 (see Table 2). Of the substances added to Annex I, many
were proposed for inclusion in Parts 1 and 2 of Annex I to the PIC Regulation because
they had been banned for use as plant protection products under Regulation (EC) No
1107/2009, which represented a ban or severe
restriction in the use category ‘pesticide’.
This was the case for bitertanol, cyhexatin, azocyclotin, cinidon-ethyl, cyclanilide,
ethoxysulfuron, oxadiargyl, didecyldimethylammonium chloride, and warfarin in 2014,
and fenbutatin oxide in 2015. In addition, substances severely restricted as pesticides,
such as rotenone and cyfluthrin in 2014, were added to Annex I.
Table 2 : Substances added to Annex 1 during the reporting period
Delegated Act
Commission
Delegated
Regulation
(EU)
No 1078/2014 of
7 August 2014
amending Annex I
to Regulation (EU)
No 649/2012
Chemical
Azocyclotin
Bitertanol
Cinidon-ethyl
Cyclanilide
Cyfluthrin
Cyhexatin
Ethoxysulfuron
Didecyldimethylammonium
Chloride
Oxadiargyl
Rotenone
Warfarin
Azinphos-methyl
Perfluorooctane sulfonic acid
Perfluorooctane sulfonates
Perfluorooctane sulfonamides
Perfluorooctane sulfonyls
1,1-Dichloroethene
1,1,2-Trichloroethane
1,1,1,2-Tetrachloroethane
1,1,2,2-Tetrachloroethane
Dibutyltin compounds
Dioctyltin compounds
Fenbutatin oxide
Lead compounds
Pentachloroethane
Trichlorobenzene
Commercial
pentabromodiphenyl ether,
including: tetrabromodiphenyl
ether, and pentabromodiphenyl
ether
Commercial octabromodiphenyl
ether, including
hexabromodiphenyl ether and
heptabromodiphenyl ether
Amendment
of Annex I
Part 1 and 2
Part 1 and 2
Part 1 and 2
Part 1 and 2
Part 1and 2
Part 1 and 2
Part 1 and 2
Part 1
Part
Part
Part
Part
Part
Part
Part
Part
Part
Part
Part
Part
Part
Part
Part
Part
Part
Part
Part
1 and 2
1 and 2
1
3
3
3
3
3
1
1
1
1
1
1
1 and 2
1
1
1
3
Basis for
inclusion
PPPR
PPPR
PPPR
PPPR
PPPR
PPPR
PPPR
PPPR
PPPR
PPPR
PPPR
Annex III
Annex III
Annex III
Annex III
Annex III
REACH
REACH
REACH
REACH
REACH
REACH
PPPR
REACH
REACH
REACH
Annex III
to
to
to
to
to
RC
RC
RC
RC
RC
Commission
Delegated
Regulation
(EU)
2015/2229 of 29
September 2015
amending Annex I
to Regulation (EU)
No 649/2012
to RC
Part 3
Annex III to RC
Lead compounds, dibutyltin compounds, dioctyltin compounds, trichlorobenzene,
pentachloroethane,
1,1,2,2-tetrachloroethane,
1,1,1,2-tetrachloroethane,
1,1,2-
trichloroethane and 1,1-dichloroethene were added to Annex I in 2015, as they were
severely restricted as industrial chemicals for public use under the REACH Regulation.
61
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Amendments to Part 3 of Annex I reflect the decisions of the CoP to include certain
chemicals in Annex III to the Convention, bringing them under the PIC procedure.
Azinphos-methyl,
perfluorooctane
sulfonic
acid,
perfluorooctane
sulfonates,
perfluorooctane
sulfonamides
and
perfluorooctane
sulfonyls,
commercial
pentabromodiphenyl ether including tetra- and pentabromodiphenyl ether, as well as
commercial octabromodiphenyl ether including hexa- and heptabromodiphfaenyl ether,
were included in Part 3 of Annex I during the reporting period, following their inclusion
in Annex III to the Rotterdam Convention.
The inclusion of other substances in Annex I was under discussion in 2016, but has not
yet been formally adopted through a Delegated Regulation. These substances are listed
in Table 3.
Table 3 : Chemicals proposed for inclusion in Annex I
Chemical
Tepraloxydim
Carbendazim
Triflumuron
Triclosan
cybutryne
2,4-dinitrotoluene
4,4’-