Europaudvalget 2025
KOM (2025) 0504
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EUROPEAN
COMMISSION
Brussels, 21.5.2025
COM(2025) 504 final
2025/0134 (COD)
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
amending Regulations (EU) No 765/2008, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426,
(EU) 2023/1230, (EU) 2023/1542 and (EU) 2024/1781 as regards digitalisation and
common specifications
(Text with EEA relevance)
{SWD(2025) 130 final}
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EXPLANATORY MEMORANDUM
1.
•
CONTEXT OF THE PROPOSAL
Reasons for and objectives of the proposal
In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’
1
, the
Commission stressed the importance of a regulatory system that ensures objectives are
reached at minimum costs. To that end it committed to a dedicated effort to rationalise and
simplify reporting requirements and administrative burdens, with the ultimate aim of reducing
such requirements by 25% without undermining the related policy objectives.
Reporting requirements play a key role in ensuring the correct enforcement and proper
monitoring of legislation. The costs of reporting are overall largely offset by the benefits they
bring, in particular as regards monitoring and ensuring compliance with key policy measures.
However, reporting requirements can also impose a disproportionate burden on stakeholders,
particularly SMEs and micro-companies. The accumulation of these requirements over time
can result in redundant, duplicate or obsolete obligations, inefficient frequency and timing, or
inadequate methods of collection.
The Commission promotes the ‘digital by default’ principle in its Digital Strategy/ Better
regulation to support digital transformations, facilitating digital-ready policies that take into
account the fast-evolving world of digitalisation and technology and are digital, interoperable,
future-proof and agile by default. However, there are still various pieces of EU legislation that
provide for the use of paper format.
The Communication ‘A Competitiveness Compass for the EU’
2
highlights that digitalisation
goes hand in hand with simplification to reduce reporting burdens. The communication
emphasises that reporting should move to digital formats based on standardised data.
However, where digital procedures exist today, aspects such as fragmented IT ecosystems,
and inefficient data exchanges all make it burdensome for businesses to interact with public
authorities digitally.
The upcoming European Business Wallets initiative will address these challenges by
establishing digital identity for all economic operators and by providing the framework for
interoperable Business Wallets sharing verified data and credentials, enabling seamless digital
interactions between economic operators and public administrations across the Union. This
way, the European Business Wallets will build on the already existing digital solutions
designed to simplify everyday activities for European economic operators, such as the Single
Digital Gateway, the Once Only Technical System (‘OOTS’), the Digital Product Passport
(‘DPP’), eInvoice, thus building a cohesive ecosystem of digital solutions that will maximise
synergies and foster greater economic integration and innovation throughout Europe
Removing references to paper format would also force public authorities to rethink the ways
they process submissions or reporting by companies. Streamlining such submissions and
reporting by promoting digital-by-default would create new incentives to invest in data
1
2
COM(2023)168.
COM/2025/30 final.
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collection and processing with eGovernment solutions that could pave the way to a document-
free Single Market based on interoperable structured data and the once-only principle.
Moreover, while the New Legislative Framework (‘NLF’) does not impose a particular format
for the instructions for use accompanying the products, practice has shown that most market
surveillance authorities expect those instructions to be in paper format and therefore impose
this format on manufacturers.
The Blue Guide
5
provides detailed explanations on EU product rules.
Taking into account that in 2024 no less than 94% of EU households had access to internet
3
,
the paper format of instructions for use accompanying products under the scope of the
Regulations is outdated and not aligned with current technologies, consumer habits or green
objectives.
Consequently, manufacturers should be able to choose digital format for instructions for use.
Where manufacturers choose to provide instructions for use in digital format, the safety
information (including any parts of the instructions for use deemed imperative for safety)
should still be provided in paper format to protect the safety of consumers. Moreover, end-
users should be able to obtain a paper copy of the instructions upon request – at the time of
purchase and for a certain period of time after their purchase.
Streamlining reporting obligations, reducing administrative burden and promoting
digitalisation are priorities. In this context, the present proposal aims to simplify initiatives
included in the headline ambition ‘An Economy that works for the people’, a ‘European
Green deal’ and ‘Promoting our European way of life’ in the policy area of the Internal
Market, Food safety and Health, impacting a multitude of sectors.
Moreover, the Communication ‘A Competitiveness Compass for the EU’ identified the need
to search for alternative options to give businesses legal certainty regarding compliance with
EU rules in situations where harmonised standards do not exist, are not available, are not
sufficient, or there is an urgent need. Several current legislative acts already contain an
alternative option to provide businesses with legal predictability and prove compliance with
EU law, to cater for such situations. The present proposal’s objective is to align the alternative
option in legislative acts which do not provide for any alternative option to harmonised
standards. The alternative option is to be implemented in a uniform manner as regards
definition, legal effect, the conditions under which that alternative option may be adopted and
adoption procedure.
The initiative on common specifications is fully in line with the need referred to above and
aims to simplify the life of businesses that have to comply with one or several product-
specific health and safety requirements, as enshrined in sectoral regulations that make use of
harmonised standards.
The proposal aims to rationalise and digitalise economic operators’ obligations for Regulation
(EU) 2016/424 on cableway installations
4
, Regulation (EU) 2016/425 on personal protective
3
4
Source:
Digital economy and society statistics - households and individuals - Statistics Explained
Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on
cableway installations and repealing Directive 2000/9/EC (OJ L 81, 31.3.2016, p. 1,
ELI:
http://data.europa.eu/eli/reg/2016/424/oj).
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equipment
5
, Regulation (EU) 2016/426 on appliances burning gaseous fuels
6
, Regulation
(EU) 2023/1230 on machinery
7
, Regulation (EU) 2023/1542 concerning batteries and waste
batteries
8
and Regulation (EU) 2024/1781 establishing a framework for the setting of
ecodesign requirements for sustainable products
9
by a combination of measures.
Additionally, the proposal aims to align the existing fall-back option to harmonised standards
uniformly in Regulation (EU) 2016/424 on cableway installations, Regulation (EU) 2016/425
on personal protective equipment, and Regulation (EU) 2016/426 on gas appliances.
To avoid inconsistencies and an additional burden on manufacturers and to create an overall
coherence between harmonised product laws under the NLF, it is necessary to introduce a
provision that allows for the use of the DPP’s data carrier when such DPP is made mandatory
by another piece of legislation that covers the same product.
•
Consistency with existing policy provisions in the policy area
The proposal is part of a package of measures concerning simplification. It represents a
significant step in a continuous process of comprehensively reviewing existing reporting
requirements. The aim is to assess their continued relevance and make them more efficient,
ultimately streamlining regulatory procedures and reducing administrative burdens.
The rationalisation introduced by these measures will not affect achievement of the objectives
in the policy area, for the following reasons:
- The essential information required to ensure compliance with EU legislation will continue to
be made available to the relevant authorities and to end-users.
- The increased efficiency of reporting procedures will facilitate the digitalisation of business-
to-authority reporting, reduce the administrative burden on businesses and enhancing the
overall effectiveness of the regulatory framework.
- The measures will also promote a more consistent and harmonised approach to economic
operators’ obligations across different EU laws, reducing confusion and facilitating
compliance for businesses operating in multiple policy areas.
5
6
7
8
9
Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal
protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 5, ELI:
http://data.europa.eu/eli/reg/2016/425/oj).
Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on
appliances burning gaseous fuels and repealing Directive 2009/142/EC (OJ L 81, 31.3.2016, p. 99, ELI:
http://data.europa.eu/eli/reg/2016/426/oj).
Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on
machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and
Council Directive 73/361/EEC (OJ L 165, 29.6.2023, p. 1,
http://data.europa.eu/eli/reg/2023/1230/oj).
Regulation (EU) 2023/1542 of the European Parliament and of the Council of 12 July 2023 concerning
batteries and waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and
repealing
Directive
2006/66/EC
(OJ
L
191,
28.7.2023,
p.
1,
ELI:
http://data.europa.eu/eli/reg/2023/1542/oj).
Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing
a framework for the setting of ecodesign requirements for sustainable products, amending Directive
(EU) 2020/1828 and Regulation (EU) 2023/1542 and repealing Directive 2009/125/EC (OJ L,
2024/1781, 28.6.2024, ELI:
http://data.europa.eu/eli/reg/2024/1781/oj).
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- Furthermore, in cases where harmonised standards are not available, common specifications
will be accepted, ensuring consistency with existing legislative provisions in certain sectoral
policy areas and providing flexibility for businesses to demonstrate compliance.
•
Consistency with other Union policies
Under the Regulatory Fitness and Performance Programme (REFIT), the Commission ensures
that its legislation is fit for purpose, is, tailored to the needs of stakeholders and minimises
burdens while achieving its objectives. This proposal is therefore part of the REFIT
programme, aimed at reducing reporting burdens arising from Union legislation.
While certain obligations regarding requirements are essential, they need to be as efficient as
possible, avoiding overlaps, removing unnecessary burden and using digital and interoperable
solutions as much as possible.
The current proposals rationalise reporting requirements and thus make the achievement of
the objectives of legislations more efficient and less burdensome for companies and public
authorities.
In situations where harmonised standards are not available, alternative solutions are necessary
to ensure compliance with Union legislation. These alternatives should be as effective as
possible, minimising unnecessary complexity and available within short deadlines.
The introduction of these alternative solutions will streamline compliance with Union
legislation, making it more efficient and less burdensome for companies and public
authorities.
2.
•
LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY
Legal basis
The proposal is based on Article 114 of the Treaty on the Functioning of the European Union,
in line with the original legal bases for the adoption of the sectoral frameworks, which this
proposal aims to amend. These sectoral frameworks are Regulation (EU) 2016/424 on
cableway installations, Regulation (EU) 2016/425 on personal protective equipment,
Regulation (EU) 2016/426 on appliances burning gaseous fuels, Regulation (EU) 2023/1230
on machinery, Regulation (EU) 2023/1542 concerning batteries and waste batteries, and
Regulation (EU) 2024/1781 establishing a framework for the setting of ecodesign
requirements for sustainable products and Regulation (EU) 765/2008 setting out the
requirements for accreditation and market surveillance relating to the marketing of products.
A common feature of these frameworks is that they are more or less closely aligned to the
general principles and reference provision laid down in the NLF. The NLF for EU product
legislation consists of two legal acts adopted in 2008, which are Decision No 768/2008/EC of
the European Parliament and of the Council on a common framework for the marketing of
products
10
laying down reference provisions for the drawing up of Union legislation
harmonising the conditions for the marketing of products, and Regulation (EC) No 765/2008
of the European Parliament and of the Council setting out the requirements for accreditation
10
Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common
framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218,
13/08/2008, p. 82, ELI:
http://data.europa.eu/eli/dec/2008/768(1)/oj).
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and market surveillance relating to the marketing of products
11
, which sets out the principles
of the CE marking and accreditations of conformity assessment bodies.
The Union sectoral frameworks laid down by the above-mentioned Regulations are so-called
“product harmonisation legislation”. They lay down harmonised rules regarding the design,
manufacture, conformity assessment and placing on the market of products. Essentially, these
sectoral frameworks introduce for each respective sector/product category the essential
requirements of public interest which the products should meet and the procedures on how to
assess compliance with these requirements.
Thanks to the NLF, most of the above-mentioned pieces of legislation affected by this
proposal contain provisions of a similar type. The legislative acts in question, which are
aligned with the NLF, share a common structure and contain provisions based on the same
model. Hence, the obligations of economic operators, provisions concerning notified
conformity assessment bodies, accreditation, and CE marking are identical or very similar in
all these legislative acts. This uniformity facilitates familiarity with the various legislative
instruments, particularly for businesses that manufacture or distribute products subject to
multiple EU legislative acts. The consistency of these elements enables economic operators to
more easily navigate the regulatory landscape, thereby reducing complexity and promoting
compliance. However, given that the model provisions were established in 2008, certain
aspects of the obligations have become redundant or obsolete over time, necessitating a
review and update to ensure their continued relevance and effectiveness.
Amending the above-mentioned Regulations in the proposed manner, i.e. removing of paper-
based obligations and transitioning to digital equivalents will contribute to the digitalisation of
business-to-authority reporting, facilitate the digitalisation of economic operators’ obligations,
and enhance the overall efficiency and effectiveness of the regulatory framework.
•
Subsidiarity (for non-exclusive competence)
The reporting requirements and economic operators’ obligations concerned are imposed by
Union law and can therefore only be amended at Union level. Member States, companies and
consumers will benefit from the removal of references to paper format and the digitalisation
of the EU declaration of conformity for economic operators that is the subject of this
proposal.
•
Proportionality
The rationalisation and digitalisation of reporting requirements for economic operators’
obligations simplifies the legal framework by introducing minimum changes to existing
requirements that do not affect the substance of the wider policy objective. The proposal is
therefore limited to those changes that are necessary to ensure efficiency without changing
any of the substantial elements of the legislation concerned.
The amendments introduce minimal changes to existing requirements, focusing solely on the
removal of paper-based references and the digitalisation of the EU declaration of conformity
and instructions. By limiting the proposal to these necessary changes, the Commission
ensures that the amendments are proportionate to the objectives pursued and do not
compromise achievement of the policy goals.
11
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out
the requirements for accreditation and market surveillance relating to the marketing of products and
repealing
Regulation
(EEC)
No
339/93
(OJ
L
218,
13.8.2008,
p.
30,
ELI:
http://data.europa.eu/eli/reg/2008/765/oj).
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Common specifications as a fall-back option to harmonised standards simplify the legal
framework by ensuring consistency in the internal market in the absence of available
harmonised standards. The proposal is therefore limited to those changes that are necessary to
ensure efficiency without changing any of the substantial elements of the legislation
concerned.
The amendments introduce minimal changes to existing legislation, focusing solely on
aligning common specifications in internal market legislation. By limiting the proposal to
these necessary changes, the Commission ensures that the amendments are proportionate to
the objectives pursued and do not compromise achievement of the policy goals.
•
Choice of the instrument
All the regulations to be amended by this Regulation are sectoral pieces of harmonised
product legislation under the single market rules and are aligned with the NLF. They all
contain paper format references and references to the concept of harmonised standards and
presumption of conformity.
The Evaluation of the NLF, published in November 2022, revealed that the NLF has
successfully harmonised EU product legislation, resulting in a more coherent framework that
has reduced burdens and generated cost savings for both businesses and authorities since
2008. However, the evaluation also highlighted that the NLF's outdated requirements, such as
paper-based documentation and correspondence, hinder its ability to keep pace with
digitalisation and meet modern expectations.
In conclusion, this omnibus is the best choice as legal instrument due to its ability to
efficiently adapt to future needs and remain relevant by allowing for the removal of outdated
references, such as to paper formats.
3.
RESULTS
OF
EX-POST
EVALUATIONS,
CONSULTATIONS AND IMPACT ASSESSMENTS
•
N/A
•
Stakeholder consultations
On 14 April 2025, the Commission organised an outreach event in the context of the
Industrial Forum Task Force 1.
Members States, industry associations, manufacturers and consumer associations were invited
to attend and to give their opinions on the digitalisation of reporting and manufacturer’s
obligations. In particular, they were asked whether they believe providing the declaration of
conformity and the instructions in electronic form would be seen as a burden reduction.
Answers received during the outreach event show that stakeholders are largely in favour of
digitalisation as a form of burden reduction, with the vast majority of respondents indicating
they consider digitalisation an effective way of reducing burden. Moreover, the majority of
respondents indicated that they consider the digital declaration of conformity and the option to
provide for digital instructions for use as burden reduction tool. As regards digital
instructions, the majority of respondents expressed a preference for voluntary digital
instructions (only if the manufacturer decides on this option).
Ex-post evaluations/fitness checks of existing legislation
STAKEHOLDER
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In parallel, a written consultation was conducted via the same forum to gather stakeholders’
opinions and any data on cost saving that this initiative could bring. The majority of
respondents indicated they were in favour of digitalisation, including the digital declaration of
conformity and digital instructions.
•
Collection and use of expertise
The proposed simplification measures were identified following a process of internal scrutiny
of existing reporting obligations and based on the experience gained from implementation of
the related legislation. Since this is a step in the process of continuous assessment of reporting
requirements arising from Union legislation, the scrutiny of such burden and of its impact on
stakeholders will continue.
•
Impact assessment
The proposal concerns limited and targeted changes of legislation with a view to simplify
reporting requirements and digitalisation and alignment of common specifications. They are
based on experience gained from implementing legislation. The changes do not have a
significant impact on the policy, but ensure more efficient and effective implementation, also
through aligning common specifications with standing legislation.
•
•
N/A
4.
N/A
5.
•
N/A
•
N/A
•
Detailed explanation of the specific provisions of the proposal
This proposal includes:
–
Specifying that the EU declaration of conformity, or a similar document, must be
drawn up in electronic form and made accessible through an internet address or
machine-readable code when that declaration needs to accompany a product;
The addition of a ‘digital contact’ as information to be indicated by manufacturers on
the products which are placed on the market in order to facilitate communication
between economic operators and national authorities. Once the European Business
Wallet is available, the digital address it provides to economic operators could
constitute the “digital contact”;
Explanatory documents (for directives)
OTHER ELEMENTS
Implementation plans and monitoring, evaluation and reporting arrangements
BUDGETARY IMPLICATIONS
Regulatory fitness and simplification
Fundamental rights
This is a REFIT proposal, aiming to simplify legislation and cut burdens for stakeholders.
–
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–
Specifying that the instructions accompanying products may be provided in
electronic form, with the exception of safety information which should be provided
on paper or marked on the product for consumers;
The amendment of reporting obligations to national authorities that require a ‘paper
or electronic format’ to ‘electronic form’ only;
The insertion of an obligation for exchanges by electronic means between the
economic operators and competent authorities;
The introduction of a provision on common specifications as an alternative to
harmonised standards;
An obligation to provide the information contained in the EU declaration of
conformity and instructions on the digital product passport when the product is
subject to other Union legislation that requires the use of such a digital product
passport.
–
–
–
–
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2025/0134 (COD)
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
amending Regulations (EU) No 765/2008, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426,
(EU) 2023/1230, (EU) 2023/1542 and (EU) 2024/1781 as regards digitalisation and
common specifications
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular
Article 114 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee
1
,
Acting in accordance with the ordinary legislative procedure,
Whereas:
(1)
Reporting requirements play a key role in ensuring proper monitoring and correct
enforcement of legislation. However, in order to ensure that they fulfil their intended
purpose and to limit the administrative burden, it is important to streamline those
requirements.
In its Communication on ‘Long-term competitiveness of the EU: looking beyond
2030’
6
, the Commission has committed to rationalise and simplify reporting
requirements, with the aim to reduce such burdens by 25%, without undermining the
related policy objectives.
In its Better regulation Guidelines
2
, the Commission promotes the ‘digital by default’
principle to support digital transformations, by facilitating digital-ready policies which
consider the fast-evolving world of digitalisation and technology, and which are
digital, interoperable, future-proof and agile by default.
The increasing importance of digitalisation in simplifying regulatory frameworks
necessitates the reduction and modernisation of reporting requirements and economic
operators’ obligations. In line with the efforts to accelerate digitalisation, it is essential
to fully digitalise business-to-authority reporting and economic operators’ obligations
when they do not affect protection and safety of consumers. Embracing digitalisation
OJ C , , p. .
https://commission.europa.eu/law/law-making-process/planning-and-proposing-law/better-
regulation/better-regulation-guidelines-and-toolbox_en.
(2)
(3)
(4)
1
2
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will not only simplify compliance procedures but also enhance the overall efficiency
of the regulatory framework, ultimately benefiting both businesses and authorities
alike.
(5)
A number of sectoral Union legal acts lay down harmonised rules regarding the
obligations of economic operators when placing a product on the market or putting it
into service. Such legal acts include Regulations (EU) 2016/424
3
, (EU) 2016/425
4
,
(EU) 2016/426
5
, (EU) 2023/1230
6
, (EU) 2023/1542
7
and (EU) 2024/1781
8
of the
European Parliament and of the Council (the ‘Regulations concerned’). The
Regulations concerned are based on the principles of the ‘new approach’ to technical
harmonisation and are aligned with the reference provisions laid down in Decision No
768/2008/EC of the European Parliament and of the Council
9
.
In accordance with the Regulations concerned, manufacturers are to draw up an EU
declaration of conformity stating that the fulfilment of essential requirements set out in
the applicable Regulations has been demonstrated. In order to enable seamless
electronic processes, the EU declaration of conformity should be drawn up only in
electronic form.
Moreover, Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, and (EU)
2023/1230 require that a copy of the declaration of conformity accompanies the
product. Considering the evolution of digitalisation, it is essential to modernise this
obligation by requiring that such EU declaration of conformity electronically
accompany the product. The manufacturer will make sure that the EU declaration of
conformity is accessible through an internet address or a machine-readable code.
Taking into account that in 2024 no less than 94% of EU households had access to
internet
10
, the paper format of the instructions accompanying the products under the
scope of the Regulations concerned is outdated and not aligned with the current
technologies, the practice of consumers nor with green objectives. Consequently, the
possibility for a digital format of the instructions should be introduced in the
Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on
cableway installations and repealing Directive 2000/9/EC (OJ L 81, 31.3.2016, p. 1, ELI:
http://data.europa.eu/eli/reg/2016/424/oj).
Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal
protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51, ELI:
http://data.europa.eu/eli/reg/2016/425/oj).
Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on
appliances burning gaseous fuels and repealing Directive 2009/142/EC (OJ L 81, 31.3.2016, p. 99, ELI:
http://data.europa.eu/eli/reg/2016/426/oj).
Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on
machinery and amending Directive (EU) 2021/647 (OJ L 165, 29.6.2023, p. 1, ELI:
http://data.europa.eu/eli/reg/2023/1230/oj).
Regulation (EU) 2023/1542 of the European Parliament and of the Council of 12 July 2023 concerning
batteries and waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and
repealing
Directive
2006/66/EC
(OJ
L
191,
28.7.2023,
p.
1,
ELI:
http://data.europa.eu/eli/reg/2023/1542/oj).
Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing
a framework for the setting of ecodesign requirements for sustainable products, amending Directive
(EU) 2020/1828 and Regulation (EU) 2023/1542 and repealing Directive 2009/125/EC (OJ L 281,
28.6.2024, p. 1, ELI:
http://data.europa.eu/eli/reg/2024/1781/oj).
Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common
framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218,
13.8.2008, p. 82, ELI:
http://data.europa.eu/eli/dec/2008/768(1)/oj).
Source:
Digital economy and society statistics - households and individuals - Statistics Explained.
(6)
(7)
(8)
3
4
5
6
7
8
9
10
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Regulations concerned. This will allow manufacturers to provide instructions in digital
format, if they wish to do so. Where manufacturers choose to provide instructions in
digital format, in order to still protect the safety of consumers, the safety information,
including instructions having impact on product safety, should be provided in paper
format or marked on the product. Moreover, end-users should be able to obtain a paper
copy of the instructions for use or safety information, upon request – at the time of the
purchase and for a certain period of time after their purchase.
(9)
In order to facilitate communication between economic operators and national
competent authorities and end-users, the indication of a digital contact of the
manufacturer on the product and in the EU declaration of conformity is necessary to
enhance the effectiveness of market surveillance and to expedite the process of tracing
non-compliant products. Currently, economic operators are required to indicate their
postal address on the product, but this is not always sufficient to ensure that competent
authorities can establish rapid contact. It is therefore necessary to require economic
operators to provide both a postal address and a digital contact on the product and in
the EU declaration of conformity. Such digital contact should be defined in the
Regulations concerned.
The Regulations concerned require that economic operators provide, on a reasoned
request from a competent national authority, all information and documentation
necessary to demonstrate the conformity of the concerned products with the respective
Regulations, in paper or electronic form. The paper-based form is an outdated
requirement, while electronic communication enhances interaction between authorities
and businesses, streamlining processes and reducing administrative burdens. In order
to achieve the digitalisation of reporting requirements and to reduce administrative
burden for economic operators and competent authorities, the economic operators
should be required to provide the necessary information and documentation in
electronic form only. Documentation provided in electronic form could be made
available, for example, in a digital printable format, which allows the possibility to
print, download and save the documentation on an electronic device.
The current Union standardisation framework, which is based on Regulation (EU) No
1025/2012 of the European Parliament and of the Council
11
, represents the framework
by default to elaborate standards that provide for a presumption of conformity with the
relevant essential health and safety or other requirements. However, where no
harmonised standards exist or where they are insufficient, the Commission should be
able to adopt implementing acts establishing common specifications for the essential
health and safety or other requirements, as an exceptional fall-back solution to
facilitate the manufacturer’s obligation to comply with those health and safety or other
requirements.
As the digital product passport is foreseen in certain EU legislation, such as
Regulation (EU) 2023/1542, it is essential to require economic operators to store the
information contained in the EU declaration of conformity and instructions in the
digital product passport where a product is covered by multiple pieces of legislation.
Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on
European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives
94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and
2009/105/EC of the European Parliament and of the Council and repealing Council Decision
87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316,
14.11.2012, p. 12, ELI:
http://data.europa.eu/eli/reg/2012/1025/oj).
(10)
(11)
(12)
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This approach would reduce the administrative burden on manufacturers, as they
would no longer need to maintain separate storage locations for compliance
documents. By storing the documentation in one place, all necessary documents
demonstrating product compliance would be easily accessible, ensuring transparency
and facilitating compliance. This streamlined approach would enhance the overall
efficiency of the regulatory framework, and it aligns with the principle that where
several pieces of Union harmonisation legislation apply to a product, the manufacturer
or other economic operator, where appropriate, should provide a single EU declaration
of conformity.
(13)
Since the objectives of this Regulation cannot be sufficiently achieved by the Member
States as this Regulation amends Regulations which are harmonising products
legislations but can rather by reason of better harmonisation of EU applicable rules to
products, be achieved at Union level, the Union may adopt measures, in accordance
with the principle of subsidiarity as set out in Article 5 of the Treaty on European
Union. In accordance with the principle of proportionality, as set out in that Article,
this Regulation does not go beyond what is necessary in order to achieve those
objectives.
To ensure a smooth and effective transition, to minimize disruptions, and to provide a
reasonable timeframe for industries to adjust to the new requirements amendments to
Regulations (EU) 765/2008, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU)
2019/1009, (EU) 2023/1542 and (EU) 2024/1781 concerning digitalisation should be
deferred. Amendments to Regulation (EU) 2023/1230 should apply from the date of
application of that Regulation.
In order to enable economic operators to supply stock of products that have been
placed on the market before the date of application of amendments to Regulations
(EU) 765/2008, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009,
(EU) 2023/1542 and (EU) 2024/1781 concerning digitalisation, it is necessary to
provide for reasonable transitional arrangements that do not impede the making
available on the market of products that have been placed on the market in accordance
with those Regulations in their version applicable before that date.
Regulations (EU) 765/2008, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU)
2019/1009, (EU) 2023/1230, (EU) 2023/1542 and (EU) 2024/1781 should therefore be
amended accordingly,
(14)
(15)
(16)
HAVE ADOPTED THIS REGULATION:
Article 1
Amendments to Regulation (EU) 765/2008
Regulation (EU) 765/2008 is amended as follows:
(1)
Article 2 is amended as follows:
(a)
the following point (9a) is inserted:
‘(9a) ‘a common specification’ means a set of technical requirements, other than a standard,
that provides a means of complying with the legal obligations applicable to a product, device,
service, process or system;’;
(b)
paragraph 10 is replaced by the following:
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‘10. ‘accreditation’ shall mean an attestation by a national accreditation body that a
conformity assessment body meets the requirements set by harmonised standards or common
specifications and, where applicable, any additional requirements including those set out in
relevant sectoral schemes, to carry out a specific conformity assessment activity;’;
(2)
in Article 10, paragraph 5 is replaced by the following:
‘5. Peer evaluation shall ascertain whether the national accreditation bodies meet the
requirements laid down in Article 8, taking into account the relevant harmonised standards or
common specifications referred to in Article 11.’;
(3)
in Article 11, paragraph 1 is replaced by the following:
‘1. National accreditation bodies that demonstrate conformity with the criteria laid down in
the relevant harmonised standard, the reference of which has been published in the Official
Journal of the European Union, or with the criteria laid down in common specifications , by
having successfully undergone peer evaluation under Article 10 shall be presumed to fulfil the
requirements laid down in Article 8.’.
Article 2
Amendments to Regulation (EU) 2016/424
Regulation (EU) 2016/424 is amended as follows:
(1)
Article 3 is amended as follows:
(a)
the following point (17a) is inserted:
‘(17a) ‘digital contact’ means any up-to-date and accessible online communication channel
through which economic operators can be reached or engaged without the need to register or
to download an application;’;
(b)
the following point (19a) is inserted:
‘(19a) ‘common specifications’ means a set of technical requirements, other than a standard,
that provide means of complying with the essential requirements applicable to a product,
device, service, process or system;’;
(2)
Article 11 is amended as follows:
(a)
in paragraph 2, the second subparagraph is replaced by the following:
‘Where compliance of a subsystem or a safety component with the applicable requirements
has been demonstrated by the procedure referred to in the first subparagraph, manufacturers
shall draw up an EU declaration of conformity, in electronic form, and affix the CE
marking.’;
(b)
in paragraph 4, first subparagraph, the second sentence is replaced by the
following:
‘Changes in subsystem or safety component design or characteristics and changes in the
harmonised standards or in the common specifications or in other technical specifications by
reference to which the conformity of the subsystem or the safety component is declared shall
be adequately taken into account.’;
(c)
in paragraph 6, the first and second sentences are replaced by the following:
‘Manufacturers shall indicate on the subsystem or the safety component their name, registered
trade name or registered trademark as well as their postal address and digital contact or, where
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that is not possible, on the packaging or in a document accompanying the subsystem or safety
component. The postal address and digital contact shall indicate a single point through which
the manufacturer can be reached.’;
(d)
paragraph 7 is replaced by the following:
‘7. Manufacturers shall ensure that the subsystem or the safety component is accompanied by
the internet address or machine-readable code through which the EU declaration of
conformity can be accessed and by the instructions and safety information, in a language
which can be easily understood by end-users, as determined by the Member State concerned.
The instructions and safety information may be provided in electronic form. Such instructions
and safety information shall be clear, understandable and intelligible.
The manufacturer shall take into account the intended use and the foreseeable end-user of the
product when deciding the specific format for the instructions and safety information. When
drafting the safety information, the manufacturers shall take account of the intended use and
foreseeable misuse by the end-user, as well as the role which the instructions play for
ensuring safety.
However, where a large number of subsystems or safety components are delivered to a single
economic operator or end-user, the batch or consignment concerned may be accompanied by
a single internet address or machine-readable code through which the EU declaration of
conformity can be accessed.
When the instructions, referred to in the first subparagraph, are provided in electronic form
the manufacturer shall:
(a) mark on the subsystem or the safety component, or, where that is not possible, on its
packaging or in an accompanying document, how to access them and how to request them in
paper format;
(b) present them in a format that makes it possible for the end-user to print and download the
instructions and save them on an electronic device so that the end-user can access them at all
times, in particular during a breakdown of the subsystem or the safety component; this
requirement also applies where the instructions are embedded in the software of the
subsystem or the safety component;
(c) make them accessible online during the expected lifetime of the subsystem or the safety
component and for at least 30 years after the placing on the market of the subsystem or the
safety component.
However, the end-user may, at time of the purchase of the product, or up to six months after
that purchase, request the instructions or safety information in paper format. Where the end-
user requests those instructions or safety information, the manufacturer shall provide them to
the end-user, free of charge, within one month of receiving the request.’;
(e)
paragraph 9 is replaced by the following:
‘9. Manufacturers shall, further to a reasoned request from a competent national authority,
provide it, in electronic form, with all the information and documentation necessary to
demonstrate the conformity of the subsystem or the safety component with this Regulation, in
a language which can be easily understood by that authority. They shall cooperate with that
authority, at its request, on any action taken to eliminate the risks posed by subsystems or
safety components which they have placed on the market.’;
(3)
in Article 12(2), point (b) is replaced by the following:
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‘(b) further to a reasoned request from a competent national authority, provide that authority,
in electronic form, with all the information and documentation necessary to demonstrate the
conformity of the subsystem or the safety component;’;
(4)
Article 13 is amended as follows:
(a)
in paragraph 2, first subparagraph, the second sentence is replaced by the
following:
‘They shall ensure that the manufacturer has drawn up the technical documentation, that the
subsystem or the safety component bears the CE marking and that it is accompanied by the
internet address or machine-readable code through which the EU declaration of conformity
can be accessed and by the instructions and safety information and, where appropriate, by
other required documents, and that the manufacturer has complied with the requirements set
out in Article 11(5) and (6).’;
(b)
in paragraph 3, first subparagraph, the first sentence is replaced by the
following:
‘Importers shall indicate on the subsystem or the safety component their name, registered
trade name or registered trademark as well as their postal address and digital contact or, where
that is not possible, on its packaging or in a document accompanying the subsystem or safety
component.’;
(c)
paragraph 9 is replaced by the following:
‘9. Importers shall, further to a reasoned request from a competent national authority,
provide it, in electronic form, with all the information and documentation necessary to
demonstrate the conformity of a subsystem or a safety component, in a language which can be
easily understood by that authority. They shall cooperate with that authority, at its request, on
any action taken to eliminate the risks posed by subsystems or safety components which they
have placed on the market.’;
(5)
Article 14 is amended as follows:
(a)
in paragraph 2, the first subparagraph is replaced by the following:
‘Before making a subsystem or a safety component available on the market, distributors shall
verify that the subsystem or the safety component bears the CE marking and that it is
accompanied by the internet address or machine-readable code through which the EU
declaration of conformity can be accessed and by the instructions and safety information and,
where appropriate, by other required documents, in a language which can be easily
understood by end-users as determined by the Member State concerned, and that the
manufacturer and the importer have complied with the requirements set out in Article 11(5)
and (6) and Article 13(3) respectively.’;
(b)
paragraph 5 is replaced by the following:
‘5. Distributors shall, further to a reasoned request from a competent national authority,
provide it, in electronic form, with all the information and documentation necessary to
demonstrate the conformity of a subsystem or a safety component. They shall cooperate with
that authority, at its request, on any action taken to eliminate the risks posed by subsystems or
safety components which they have made available on the market.’;
(6)
the following Article 17a is inserted:
‘Article
17a
Common Specifications
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1.
The Commission may by means of implementing acts adopt common specifications
that enable compliance with the essential requirements set out in Annex II in any of
the following cases:
(a) requirements set out in Annex II are not covered by harmonised standards, or
parts thereof, the references of which have been published in the Official Journal of
the European Union;
(b) requirements set out in Annex II are covered by harmonised standards, or parts
thereof, the references of which have been published in the Official Journal of the
European Union, but application of those standards or parts thereof result in non-
compliance of a product with the essential requirements set out in Annex II; or
(c) where the Commission considers that there is a need to address an urgent concern
with regard to non-compliant subsystems and safety components.
Those implementing acts shall be adopted in accordance with the advisory procedure referred
to in Article 44(2).
2.
Subsystems and safety components that are in conformity with common
specifications or parts thereof shall be presumed to be in conformity with essential
requirements covered by those specifications or parts thereof, set out in Annex II.’;
in Article 18, paragraph 3 is replaced by the following:
(7)
‘3. Records and correspondence relating to the conformity assessment procedures shall be
drawn up, in electronic form, in an official language of the Member State where the notified
body carrying out the procedures referred to in paragraph 2 is established or in a language
accepted by that body. The manufacturer shall provide the notified body carrying out the
conformity assessment procedure with all the information and documentation relating to
conformity assessment procedures in electronic form.’;
(8)
in Article 19, the following paragraph 5 is added:
‘5. Where other Union legislation applicable to subsystem or a safety component requires the
economic operator to include the information that the product complies with the requirements
set out in that legislation in a digital product passport or to upload the EU declaration of
conformity or instructions in a digital product passport, the information required in in Annex
IX to be included in the EU declaration of conformity and referred to in Article 11(7) shall be
provided only in that digital product passport.’;
(9)
in Article 26, paragraph 7, point (c) is replaced by the following:
‘(c) appropriate knowledge and understanding of the essential requirements set out in Annex
II, of the applicable harmonised standards or common specifications and of the relevant
provisions of Union harmonisation legislation and of national legislation;’;
(10)
in Article 34, paragraph 3 is replaced by the following:
‘3. Where a notified body finds that the essential requirements set out in Annex II or
corresponding harmonised standards or common specifications or other technical
specifications have not been met by a manufacturer, it shall require that manufacturer to take
appropriate corrective measures and shall not issue a certificate or approval decision.’;
(11)
in Article 43(1), point (d) is replaced by the following:
‘(d) the subsystem or safety component is not accompanied by the internet address or
machine-readable code through which the EU declaration of conformity can be accessed;’.
(12)
Annexes III to IX are amended in accordance with Annex I to this Regulation.
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Article 3
Amendments to Regulation (EU) 2016/425
Regulation (EU) No 2016/425 is amended as follows:
(1)
Article 3 is amended as follows:
(a)
the following point (8a) is inserted:
‘(8a) ‘digital contact’ means any up-to-date and accessible online communication channel
through which economic operators can be reached or engaged without the need to register or
to download an application;’;
(b)
the following point (10a) is inserted:
‘(10a) ‘common specifications’ means a set of technical requirements, other than a standard,
that provides a means of complying with the essential requirements applicable to a product,
device, service, process or system;’;
(2)
Article 8 is amended as follows:
(a)
in paragraph 2, the second subparagraph is replaced by the following:
‘Where compliance of PPE with the applicable essential health and safety requirements has
been demonstrated by the appropriate procedure, manufacturers shall draw up the EU
declaration of conformity referred to in Article 15, in electronic form, and affix the CE
marking referred to in Article 16.’;
(b)
in paragraph 4, first subparagraph, the second sentence is replaced by the
following:
‘Changes in the design or characteristics of the PPE and changes in the harmonised standards,
or in the common specifications, or in other technical specifications by reference to which the
conformity of the PPE is declared shall be adequately taken into account.’;
(c)
in paragraph 6, the first and second sentences are replaced by the following:
‘Manufacturers shall indicate, on the PPE, their name, registered trade name or registered
trademark as well as their postal address and digital contact or, where that is not possible, on
its packaging or in a document accompanying the PPE. The postal address and digital contact
shall indicate a single point through which the manufacturer can be reached.’;
(d)
paragraphs 7 and 8 are replaced by the following:
‘7. Manufacturers shall ensure that the PPE is accompanied by the instructions and
information set out in point 1.4 of Annex II, in a language which can be easily understood by
consumers and other end-users, as determined by the Member State concerned. The
instructions and information may be provided in electronic form. Such instructions and
information, as well as any labelling, shall be clear, understandable, intelligible and legible.
The manufacturer shall take into account the intended use and the foreseeable end-user of the
PPE when deciding the specific format for the instructions and information set out in point 1.4
of Annex II.
In the case of PPE intended for consumers or that can, under reasonably foreseeable
conditions, be used by consumers, even if not intended for them, the manufacturer shall
provide, in paper format, or make them visible on the packaging, the instructions and
information set out in point 1.4 of Annex II.. Such information shall be easily visible and
legible for consumers.
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When drafting the instructions and information set out in point 1.4 of Annex II, the
manufacturers shall take account of the intended use and foreseeable misuse by the end-user.
When the instructions, referred to in the first subparagraph, are provided in electronic form,
the manufacturer shall:
(a) mark on the PPE, or, where that is not possible, on its packaging or in an accompanying
document, how to access them and how to request them in paper format;
(b) present them in a format that makes it possible for the end-user to print and download the
instructions and save them on an electronic device so that the end-user can access them at all
times, in particular during a breakdown of the PPE; this requirement also applies where the
instructions are embedded in the software of the PPE;
(c) make them accessible online during the expected lifetime of the PPE and for at least 10
years after the placing on the market of the PPE.
However, the end-user may, at time of the purchase of the PPE, or up to six months after that
purchase, request the instructions and information set out in point 1.4 of Annex II in paper
format. Where the end-user requests those instructions and information set out in point 1.4 of
Annex II, the manufacturer shall provide them to the end-user, free of charge, within one
month of receiving the request.
8. The manufacturer shall provide the internet address or machine-readable code through
which the EU declaration of conformity can be accessed with the PPE.’;
(e)
in paragraph 10, the first sentence is replaced by the following:
‘Manufacturers shall, further to a reasoned request from a competent national authority,
provide it, in electronic form, with all the information and documentation necessary to
demonstrate the conformity of the PPE with this Regulation, in a language which can be
easily understood by that authority.’;
(3)
in Article 9(2), point (b) is replaced by the following:
‘(b) further to a reasoned request from a competent national authority, provide that authority,
in electronic form, with all the information and documentation necessary to demonstrate the
conformity of the PPE;’;
(4)
Article 10 is amended as follows:
(a)
in paragraph 3, the first sentence is replaced by the following:
‘Importers shall indicate, on the PPE, their name, registered trade name or registered
trademark as well as their postal address and digital contact through which they can be
reached or, where that is not possible, on its packaging or in a document accompanying the
PPE.’;
(b)
in paragraph 9, the first sentence is replaced by the following:
‘Importers shall, further to a reasoned request from a competent national authority, provide it,
in electronic form, with all the information and documentation necessary to demonstrate the
conformity of PPE in a language which can be easily understood by that authority.’;
(5)
in Article 11(5) the first sentence is replaced by the following:
‘Distributors shall, further to a reasoned request from a competent national authority, provide
it, in electronic form, with all the information and documentation necessary to demonstrate
the conformity of the PPE.’;
(6)
the following Article 14a is inserted:
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‘Article 14a
Common Specifications
1.
The Commission may by means of implementing acts adopt common specifications
that enable compliance with essential requirements set out in Annex II in any of the
following cases:
(a)
requirements set out in Annex II are not covered by harmonised standards, or
parts thereof, the references of which have been published in the Official
Journal of the European Union;
requirements set out in Annex II are covered by harmonised standards, or parts
thereof, the references of which have been published in the Official Journal of
the European Union, but application of those standards or parts thereof result in
non-compliance of PPE with the requirements set out in Annex II, or
where the Commission considers that there is a need to address an urgent
concern with regard to non-compliant PPE.
(b)
(c)
Those implementing acts shall be adopted in accordance with the advisory procedure referred
to in Article 44(2).
2.
PPE that is in conformity with common specifications or parts thereof shall be
presumed to be in conformity with the essential requirements covered by those
specifications or parts thereof, set out in Annex II.’;
in Article 15, the following paragraph 5 is added:
(7)
‘5. Where other Union legislation applicable to the PPE requires the economic operator to
include the information that the product complies with the requirements set out in that
legislation in a digital product passport or to upload the EU declaration of conformity or
instructions in a digital product passport, the information required in Annex IX to be included
in the EU declaration of conformity and the instructions referred to in Article 8(7) shall be
provided only in that digital product passport.’;
(8)
in Article 19, the following paragraph is added:
‘Where applicable, the manufacturer shall provide to the notified body carrying out the
conformity assessment procedure all the information and documentation relating to
conformity assessment procedures in electronic form.’;
(9)
in Article 24(7), point (c) is replaced by the following:
‘(c) appropriate knowledge and understanding of the essential health and safety requirements
set out in Annex II, of the applicable harmonised standards or common specifications, and of
the relevant provisions of Union harmonisation legislation and of national legislation’;
(10)
Article 25 is replaced by the following:
‘Where a conformity assessment body demonstrates its conformity with the criteria laid down
in the relevant harmonised standards or common specifications or parts thereof the references
of which have been published in the Official Journal of the European Union, it shall be
presumed to comply with the requirements set out in Article 24 in so far as the applicable
harmonised standards cover those requirements.’;
(11)
In Article 32, paragraph 3 is replaced by the following:
‘3. Where a notified body finds that the essential health and safety requirements set out in
Annex II or the corresponding harmonised standards, or common specifications, or other
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technical specifications have not been met by a manufacturer, it shall require the manufacturer
to take appropriate corrective measures and shall not issue a certificate or approval decision.’
(12)
Annexes II, III, V, VII, VIII, and IX are amended in accordance with Annex II to this
Regulation.
Article 4
Amendments to Regulation (EU) 2016/426
Regulation (EU) No 2016/426 is amended as follows:
(1)
Article 2 is amended as follows:
(a)
the following point (21a) is inserted:
‘(21a) digital contact’ means any up-to-date and accessible online communication channel
through which economic operators can be reached or engaged without the need to register or
to download an application;’
(b)
the following point (23a) is inserted:
‘(23a) ‘common specifications’ means a set of technical requirements, other than a standard,
that provides a means of complying with the essential requirements applicable to a product,
device, service, process or system;’;
(2)
Article 7 is amended as follows:
(a)
in paragraph 2, the second subparagraph is replaced by the following:
‘Where compliance of an appliance or a fitting with the applicable requirements has been
demonstrated by the procedure referred to in the first subparagraph, manufacturers shall draw
up an EU declaration of conformity, in electronic form, and affix the CE marking.’;
(b)
in paragraph 4, first subparagraph, the second sentence is replaced by the
following:
‘Changes in appliance or fitting design or characteristics and changes in the harmonised
standards or in the common specifications or in other technical specifications by reference to
which the conformity of the appliance or the fitting is declared shall be adequately taken into
account.’;
(c)
paragraphs 6 and 7 are replaced by the following:
‘6. Manufacturers shall indicate on the appliance their name, registered trade name or
registered trademark, as well as their postal address and digital contact or, where that is not
possible, on the packaging or in a document accompanying the appliance. The postal address
and digital contact shall indicate a single point through which the manufacturer can be
reached. The contact details shall be in a language easily understood by consumers and other
end-users and the market surveillance authorities.
Manufacturers shall indicate on the fitting their name, registered trade name or registered
trademark, as well as their postal address and digital contact or, where that is not possible, on
the packaging or in a document accompanying the fitting. The postal address and digital
contact shall indicate a single point through which the manufacturer can be reached. The
contact details shall be in a language easily understood by appliance manufacturers and the
market surveillance authorities.7. Manufacturers shall ensure that the appliance is
accompanied by instructions and safety information in accordance with point 1.5 of Annex I,
in a language which can be easily understood by consumers and other end-users, as
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determined by the Member State concerned. The instructions and safety information may be
provided in an electronic form. Such instructions and safety information, as well as any
labelling, shall be clear, understandable and intelligible.
Manufacturers shall take into account the intended use and the foreseeable end-user of the
product when deciding the specific format for the instructions and safety information.
In the case of appliance or fitting intended for consumers or that can, under reasonably
foreseeable conditions, be used by consumers, even if not intended for them, the manufacturer
shall provide, in paper format, or mark on the equipment, the safety information. Such safety
information shall be easily visible and legible for consumers.
When drafting the safety information, the manufacturers shall take account of the intended
use and foreseeable misuse by the end-user, as well as the role which the instructions play for
ensuring safety.
Manufacturers shall ensure that the fitting is accompanied by the internet address or machine-
readable code through which the EU declaration of conformity can be accessed and the
instructions for incorporation or assembly, adjustment, operation and maintenance in
accordance with point 1.7 of Annex I, in a language which can be easily understood by
appliance manufacturers, as determined by the Member State concerned. The instructions may
be provided in electronic form.
However, where a large number of fittings are delivered to a single end-user, the batch or
consignment concerned may be accompanied by a single internet address or machine-readable
code through which the EU declaration of conformity can be accessed.
When the instructions, referred to in the first subparagraph, are provided in electronic form,
the manufacturer shall:
(a) mark on the appliance or fitting, or, where that is not possible, on its packaging or in an
accompanying document, how to access them and how to request them in paper format;
(b) present them in a format that makes it possible for the end-user to print and download the
instructions and save them on an electronic device so that the end-user can access them at all
times, in particular during a breakdown of the appliance or fitting;
(c) make them accessible online during the expected lifetime of the appliance or fitting and
for at least 10 years after the placing on the market of the appliance or fitting.
However, the end-user may, at time of the purchase of the appliance or fitting, or up to six
months after that purchase, request the instructions or safety information in paper format.
Where the end-user requests those instructions or safety information, the manufacturer shall
provide them to the end-user, free of charge, within one month of receiving the request.’;’;
(d)
in paragraph 9, the first sentence is replaced by the following:
‘Manufacturers shall, further to a reasoned request from a competent national authority,
provide it, in electronic form, with all the information and documentation necessary to
demonstrate the conformity of the appliance or the fitting with this Regulation, in a language
which can be easily understood by that authority.’;
(3)
in Article 8(2), point (b) is replaced by the following:
‘(b) further to a reasoned request from a competent national authority, provide that authority,
in electronic form, with all the information and documentation necessary to demonstrate the
conformity of the appliance or the fitting;’;
(4)
Article 9 is amended as follows:
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(a)
in paragraph 2, second subparagraph, the second sentence is replaced by the
following:
‘They shall ensure that the manufacturer has drawn up the technical documentation, that the
fitting bears the CE marking and is accompanied by the internet address and machine-
readable code through which the EU declaration of conformity can be accessed and by, inter
alia, instructions for incorporation or assembly, adjustment, operation and maintenance in
accordance with point 1.7 of Annex I and that the manufacturer has complied with the
requirements set out in Article 7(5) and (6).’;
(b)
paragraph 3 is replaced by the following:
‘3. Importers shall indicate on the appliance their name, registered trade name or registered
trademark, as well as their postal address and digital contact or, where that is not possible, on
its packaging or in a document accompanying the appliance. The contact details shall be in a
language easily understood by consumers and other end-users and the market surveillance
authorities.
Importers shall indicate on the fitting their name, registered trade name or registered
trademark, as well as their postal address and digital contact or, where that is not possible, on
its packaging or in a document accompanying the fitting. The contact details shall be in a
language easily understood by appliance manufacturers and the market surveillance
authorities.’;
(c)
in paragraph 4, the second subparagraph is replaced by the following:
‘Importers shall ensure that the fitting is accompanied by the internet address or machine-
readable code through which the EU declaration of conformity can be accessed and by, inter
alia, the instructions for incorporation or assembly, adjustment, operation and maintenance in
accordance with point 1.7 of Annex I in a language which can be easily understood by
appliance manufacturers, as determined by the Member State concerned.’;
(d)
in paragraph 9, the first sentence is replaced by the following:
‘Importers shall, further to a reasoned request from a competent national authority, provide it,
in electronic form, with all the information and documentation necessary to demonstrate the
conformity of an appliance or a fitting in a language which can be easily understood by that
authority.’;
(5)
Article 10 is amended as follows:
(a)
in paragraph 2, the second subparagraph is replaced by the following:
‘Before making a fitting available on the market, distributors shall verify that the fitting bears
the CE marking and that it is accompanied by the internet address or machine-readable code
through which the EU declaration of conformity can be accessed, and by, inter alia, the
instructions for incorporation or assembly, adjustment, operation and maintenance in
accordance with point 1.7 of Annex I in a language which can be easily understood by
appliance manufacturers, as determined by the Member State concerned, and that the
manufacturer and the importer have complied with the requirements set out in Article 7(5)
and (6) and Article 9(3) respectively.’;
(6)
in paragraph 5, the first sentence is replaced by the following:
‘Distributors shall, further to a reasoned request from a competent national authority, provide
it, in electronic form, with all the information and documentation necessary to demonstrate
the conformity of an appliance or a fitting.’;
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(7)
the following Article 13a is inserted:
‘Article
13a
Common Specifications
1.
The Commission may by means of implementing acts adopt common specifications
that enable compliance with essential requirements set out in Annex I in any of the
following cases:
(a)
requirements set out in Annex I are not covered by harmonised standards, or
parts thereof, the references of which have been published in the Official
Journal of the European Union;
requirements set out in Annex I are covered by harmonised standards, or parts
thereof, the references of which have been published in the Official Journal of
the European Union, but application of those standards or parts thereof result in
non-compliance of appliances and fittings with the requirements set out in
Annex I, or
where the Commission considers that there is a need to address an urgent
concern with regard to non-compliant subsystems and safety components.
(b)
(c)
Those implementing acts shall be adopted in accordance with the advisory procedure as
provided for in Article 42(2).
2.
Appliances and fittings that are in conformity with common specifications or parts
thereof shall be presumed to be in conformity with the essential requirements
covered by those specifications or parts thereof, set out in Annex I.’;
Article 14 is amended as follows:
(a)
paragraph 4 is replaced by the following:
(8)
‘4. Records and correspondence relating to conformity assessment of an appliance or a fitting
shall be drawn up, in electronic form, in an official language of the Member State where the
notified body carrying out the procedures referred to in paragraphs 2 and 3 is established or in
a language accepted by that body.’;
(b)
the following paragraph 5 is added:
‘5. The manufacturer shall provide the notified body carrying out the conformity assessment
procedure with all the information and documentation relating to conformity assessment
procedures in electronic form.’;
(9)
Article 15 is amended as follows:
(a)
paragraph 6 is replaced by the following:
‘6. The fitting shall be accompanied by the internet address or machine-readable code through
which the EU declaration of conformity can be accessed.’;
(b)
the following paragraph 7 is added:
‘7. Where other Union legislation applicable to an appliance or a fitting requires the economic
operator to include the information that the product complies with the requirements set out in
that legislation in a digital product passport or to upload the EU declaration of conformity or
instructions in a digital product passport, the information required in Annex II to be included
in the EU declaration of conformity and the instructions referred to in Article 7(7) shall be
provided only in that digital product passport.’;
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(10)
in Article 23(7), point (c) is replaced by the following:
‘(c) appropriate knowledge and understanding of the essential requirements set out in Annex
I, of the applicable harmonised standards or common specifications and of the relevant
provisions of Union harmonisation legislation and of national legislation;’;
(11)
in Article 31, paragraph 3 is replaced by the following:
‘3. Where a notified body finds that the essential requirements set out in Annex I or
corresponding harmonised standards or common specifications or other technical
specifications have not been met by a manufacturer, it shall require that manufacturer to take
appropriate corrective measures and shall not issue a certificate or approval decision.’
(12)
in Article 40(1), point (f) is replaced by the following:
‘(f) the fitting is not accompanied by the internet address or machine-readable code through
which the EU declaration of conformity can be accessed;’;
(13)
Annexes III and V are amended in accordance with Annex III to this Regulation.
Article 5
Amendments to Regulation (EU) 2023/1230
Regulation (EU) 2023/1230 is amended as follows:
(1)
in Article 3, the following point (22a) is inserted:
‘(22a) ‘digital contact’ means any up-to-date and accessible online communication channel
through which economic operators can be reached or engaged without the need to register or
to download an application.’;
(2)
Article 10 is amended as follows:
(a)
in paragraph 2, the second subparagraph is replaced by the following:
‘Where compliance of machinery or a related product with the essential health and safety
requirements laid down in Annex III has been demonstrated by that conformity assessment
procedure, manufacturers shall draw up the EU declaration of conformity, in digital format, in
accordance with Article 21 and affix the CE marking in accordance with Article 24.’;
(b)
in paragraph 8, the first subparagraph is replaced by the following:
‘Manufacturers shall ensure that the machinery or related product is accompanied by the
internet address or machine-readable code through which the EU declaration of conformity
set out in Part A of Annex V can be accessed.’;
(c)
in paragraph 10, the first sentence is replaced by the following:
‘Manufacturers shall, further to a reasoned request from a competent national authority,
provide that authority, in digital format, with all the information and documentation necessary
to demonstrate the conformity of the machinery or related products with this Regulation, in a
language which can be easily understood by that authority.’;
(3)
Article 11 is amended as follows:
(a)
in paragraph 2, the second subparagraph is replaced by the following:
‘Where compliance of partly completed machinery with the relevant essential health and
safety requirements set out in Annex III has been demonstrated in the technical
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documentation set out in Part B, of Annex IV, manufacturers shall draw up the EU declaration
of incorporation, in digital format, in accordance with Article 22.’;
(b)
in paragraph 8, the first subparagraph is replaced by the following:
‘Manufacturers shall ensure that the partly completed machinery is accompanied by the
internet address or machine-readable code through which the EU declaration of incorporation
set out in Part B of Annex V can be accessed.’;
(c)
in paragraph 10, the first sentence is replaced by the following:
‘Manufacturers shall, further to a reasoned request from a competent national authority,
provide that authority, in digital format, with all the information and documentation necessary
to demonstrate the conformity of the partly completed machinery with this Regulation, in a
language which can be easily understood by that authority.’;
(4)
in Article 12(2), point (b) is replaced by the following:
‘(b) further to a reasoned request from a competent national authority, provide that authority,
in digital format, with all the information and documentation necessary to demonstrate the
conformity of the product within the scope of this Regulation;’;
(5)
in Article 13(9), the first sentence is replaced by the following:
‘9. Importers shall, further to a reasoned request from a competent national authority, provide
that authority, in digital format, with all the information and documentation necessary to
demonstrate conformity of the machinery or related products with this Regulation in a
language that can be easily understood by that authority.’;
(6)
in Article 14(8), the first sentence is replaced by the following:
‘Importers shall, further to a reasoned request from a competent national authority, provide
that authority, in digital format, with all the information and documentation necessary to
demonstrate the conformity of the partly completed machinery with this Regulation in a
language that can be easily understood by that authority.’;
(7)
Article 15 is amended as follows:
(a)
in paragraph 2, point (b) is replaced by the following:
‘(b) the machinery or related product is accompanied by the internet address or machine-
readable code through which the EU declaration of conformity referred to in Article 10(8) can
be accessed;’;
(b)
in paragraph 6, the first sentence is replaced by the following:
‘Distributors shall, further to a reasoned request from a competent national authority, provide
that authority, in digital format, with all the information and documentation necessary to
demonstrate the conformity of the machinery or related product with this Regulation in a
language that can be easily understood by that authority.’;
(8)
in Article 16(6), the first sentence is replaced by the following:
‘Distributors shall, further to a reasoned request from a competent national authority, provide
that authority, in digital format, with all the information and documentation necessary to
demonstrate the conformity of the partly completed machinery with this Regulation.’;
(9)
in Article 21, the following paragraph 5 is added:
‘5. Where other Union legislation applicable to machinery or related products requires the
economic operator to include the information that the product complies with the requirements
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set out in that legislation in a digital product passport or to upload the EU declaration of
conformity or instructions in a digital product passport, the information required in Parts A of
Annex V to be included in the EU declaration of conformity and the instructions referred to in
Article 10(7) shall be provided only in that digital product passport.’;
(10)
in Article 22, the following paragraph 5 is added:
‘5. Where other Union legislation applicable to machinery or related products requires the
economic operator to include the information that the product complies with the requirements
set out in that legislation in a digital product passport or to upload the EU declaration of
incorporation or instructions in a digital product passport, the information required in Parts B
of Annex V to be included in the EU declaration of incorporation and the instructions referred
to in Article 11(7) shall be provided only in that digital product passport.’;
(11)
in Article 25, the following paragraph 6 is added:
‘6. Where applicable, the manufacturer shall provide the notified body carrying out the
conformity assessment procedure with all the information and documentation relating to
conformity assessment procedures in digital format.’;
(12)
Annexes III, V, VII, IX, and X are amended in accordance with Annex IV to this
Regulation.
Article 6
Amendments to Regulation (EU) 2023/1542
Regulation (EU) 2023/1542 is amended as follows:
(1)
in Article 3 the following point (23a) is inserted:
‘(23a) ‘digital contact’ means any up-to-date and accessible online communication channel
through which economic operators can be reached or engaged without the need to register or
to download an application.’;
(2)
Article 17 is amended as follows:
(a)
paragraph 4 is replaced by the following:
‘4. Records and correspondence relating to the conformity assessment procedures of batteries
shall be drawn up, in electronic form, in the official language or languages of the Member
State where the notified body carrying out the conformity assessment procedures is
established, or in one or more languages accepted by that body.’;
(b)
the following paragraph 5 is added:
‘5. The manufacturer shall provide the notified body carrying out the conformity assessment
procedure with all the information and documentation relating to conformity assessment
procedures in electronic form.’;
(3)
(4)
in Article 18(2), the third sentence is replaced by the following:
Article 38 is amended as follows:
(a)
paragraph 1 is replaced by the following:
‘It shall be drawn up in electronic form.’;
‘1. When placing a battery on the market or putting it into service, including for the
manufacturers’ own purposes, manufacturers shall ensure that the battery:
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(a) has been designed and manufactured in accordance with Articles 6 to 10 and Articles 12
and 14, and is, for stationary battery energy storage systems, accompanied by clear,
understandable and readable instructions and safety information in a language or languages
which can be easily understood by end-users, as determined by the Member State in which the
battery is to be placed on the market or put into service; and
(b) is marked and labelled in accordance with Article 13.
The instructions and safety information for stationary battery energy storage systems may be
provided in electronic form. In the case of stationary battery energy storage systems intended
for consumers or that can, under reasonably foreseeable conditions, be used by consumers,
even if not intended for them, the manufacturer shall provide, in paper format, the safety
information.
When the instructions are provided in electronic form, the manufacturer shall mark on the
battery, or, where that is not possible, on its packaging or in an accompanying document, that
they are accessible in the battery passport and how to request them in paper format.
The end-user may, at time of the purchase of the stationary battery energy storage systems, or
up to six months after that purchase, request the instructions or safety information in paper
format. Where the end-user requests those instructions or safety information, the manufacturer
shall provide them to the end-user, free of charge, within one month of receiving the request.’;
(b)
in paragraph 7, the first sentence is replaced by the following:
‘Manufacturers shall indicate on the battery their name, registered trade name or registered
trademark as well as their postal address and digital contact, indicating a single contact
point.’;
(c)
(5)
(6)
in paragraph 10, the second sentence is replaced by the following:
‘That information and documentation shall be provided in electronic form.’;
in Article 39, the second sentence is replaced by the following:
in Article 40(3), point (b) is replaced by the following:
‘That information and documentation shall be provided, in electronic form, free of charge.’;
‘(b) further to a reasoned request from a national authority, provide it, in electronic form, with
all the information and documentation necessary to demonstrate the conformity of the
battery’;
(7)
Article 41 is amended as follows:
(a)
in paragraph 3, the first sentence is replaced by the following:
‘Importers shall indicate on the battery their name, registered trade name or registered
trademark as well as their postal address and digital contact, indicating a single contact
point.’;
(b)
(8)
(9)
in paragraph 8, the second sentence is replaced by the following:
‘That information and the documentation shall be provided in electronic form.’;
in Article 42(6), the second sentence is replaced by the following:
Annexes VIII, IX and XIII are amended in accordance with Annex V to this
Regulation.
‘That information and the documentation shall be provided in electronic form.’;
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Article 7
Amendments to Regulation (EU) 2024/1781
Regulation (EU) 2024/1781 is amended as follows:
(1)
in Article 2, the following point (46a) is inserted:
‘(46a) ‘digital contact’ means any up-to-date and accessible online communication channel
through which economic operators can be reached or engaged without the need to register or
to download an application;’;
(2)
in Article 24(2), the second sentence is replaced by the following:
‘Such information and documentation shall be provided, in electronic form, within 30 days of
receipt of the request.’;
(3)
in Article 27(10), the second sentence is replaced by the following:
‘That information and documentation shall be provided, in electronic form, as soon as
possible and in any event within 15 days of receipt of a request by that authority.’;
(4)
in Article 28(2), point (c) is replaced by the following:
‘(c) further to a reasoned request from a competent national authority, provide that authority,
in electronic form, with all the information and documentation necessary to demonstrate the
conformity of a product, in a language that can be easily understood by that authority as soon
as possible and in any event within 15 days of receipt of such a request; and’;
(5)
in Article 29(8), the second sentence is replaced by the following:
‘That information and documentation shall be provided, in electronic form, as soon as
possible and in any event within 15 days of receipt of a request by that authority.’;
(6)
in Article 30(5), first subparagraph, the second sentence is replaced by the following:
‘That information and documentation shall be provided, in electronic form, within 15 days of
receipt of a request by that authority.’;
(7)
in Annex V, point 2 is replaced by the following:
‘2. Name, postal address and digital contact of the manufacturer and, where applicable, the
manufacturer’s authorised representative.’.
Article 8
Transitional provision
Member States shall not impede the making available on the market of products which were
placed on the market in accordance with Regulations (EU) 2016/424, (EU) 2016/425, (EU)
2016/426, (EU) 2023/1542 and (EU) 2024/1781 before [OP:
please insert 24 months after
entry into force of this amending Regulation)].
Article 9
Entry into force and application
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This Regulation shall enter into force on the twentieth day following that of its publication in
the
Official Journal of the European Union.
Article 5 and Annex IV shall apply from 20 January 2027.
The following provisions shall apply from [OP:
please insert 24 months after entry into force
of this amending Regulation]:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
Article 2, point(1)(a), point (2)(a), (c), (d) and (e), and points (3), (4), (5), (7), (8) and
(11);
Article 3, point (1)(a), point (2)(a), (c), (d) and(e), and points (3), (4), (5), (7) and (8);
Article 4, point (1)(a), points (2)(a), (c) and (d), and points (3), (4), (5), (6), (8), (9)
and (12);
Articles 6 and 7;
Annex I, point (1)(a) and (c), point (2)(a), point (3)(a), point (4)(a), point (5)(a), (d)
and (e), and point (7)(a);
Annex II, point (1)(a), point (3)(a), (c)(i) and (d)(i), point (4)(a), point (5)(a) and
point (6)(a);
Annex III, point (1)(a)(i), (c), (e) and(g) and point (2)(a);
Annex V.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
For the European Parliament
The President
For the Council
The President
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3025526_0031.png
LEGISLATIVE FINANCIAL AND DIGITAL STATEMENT
1.
1.1.
1.2.
1.3.
1.3.1.
1.3.2.
1.3.3.
1.3.4.
1.4.
1.5.
1.5.1.
1.5.2.
FRAMEWORK OF THE PROPOSAL/INITIATIVE ................................................. 3
Title of the proposal/initiative ...................................................................................... 3
Policy area(s) concerned .............................................................................................. 3
Objective(s) .................................................................................................................. 3
General objective(s) ..................................................................................................... 3
Specific objective(s) ..................................................................................................... 3
Expected result(s) and impact ...................................................................................... 3
Indicators of performance ............................................................................................ 3
The proposal/initiative relates to: ................................................................................. 4
Grounds for the proposal/initiative .............................................................................. 4
Requirement(s) to be met in the short or long term including a detailed timeline for
roll-out of the implementation of the initiative ............................................................ 4
Added value of EU involvement (it may result from different factors, e.g.
coordination gains, legal certainty, greater effectiveness or complementarities). For
the purposes of this section 'added value of EU involvement' is the value resulting
from EU action, that is additional to the value that would have been otherwise
created by Member States alone. ................................................................................. 4
Lessons learned from similar experiences in the past .................................................. 4
Compatibility with the multiannual financial framework and possible synergies with
other appropriate instruments ....................................................................................... 5
Assessment of the different available financing options, including scope for
redeployment ................................................................................................................ 5
Duration of the proposal/initiative and of its financial impact .................................... 6
Method(s) of budget implementation planned ............................................................. 6
MANAGEMENT MEASURES................................................................................... 8
Monitoring and reporting rules .................................................................................... 8
Management and control system(s) ............................................................................. 8
Justification of the budget implementation method(s), the funding implementation
mechanism(s), the payment modalities and the control strategy proposed .................. 8
Information concerning the risks identified and the internal control system(s) set up
to mitigate them............................................................................................................ 8
Estimation and justification of the cost-effectiveness of the controls (ratio between
the control costs and the value of the related funds managed), and assessment of the
expected levels of risk of error (at payment & at closure) ........................................... 8
Measures to prevent fraud and irregularities ................................................................ 9
ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE ............ 10
Heading(s) of the multiannual financial framework and expenditure budget line(s)
affected ....................................................................................................................... 10
1.5.3.
1.5.4.
1.5.5.
1.6.
1.7.
2.
2.1.
2.2.
2.2.1.
2.2.2.
2.2.3.
2.3.
3.
3.1.
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3.2.
3.2.1.
Estimated financial impact of the proposal on appropriations ................................... 12
Summary of estimated impact on operational appropriations.................................... 12
3.2.1.1. Appropriations from voted budget ............................................................................. 12
3.2.1.2. Appropriations from external assigned revenues ....................................................... 17
3.2.2.
3.2.3.
Estimated output funded from operational appropriations......................................... 22
Summary of estimated impact on administrative appropriations ............................... 24
3.2.3.1. Appropriations from voted budget .............................................................................. 24
3.2.3.2. Appropriations from external assigned revenues ....................................................... 24
3.2.3.3. Total appropriations ................................................................................................... 24
3.2.4.
Estimated requirements of human resources.............................................................. 25
3.2.4.1. Financed from voted budget....................................................................................... 25
3.2.4.2. Financed from external assigned revenues ................................................................ 26
3.2.4.3. Total requirements of human resources ..................................................................... 26
3.2.5.
3.2.6.
3.2.7.
3.3.
4.
4.1.
4.2.
4.3.
4.4.
4.5.
Overview of estimated impact on digital technology-related investments ................ 28
Compatibility with the current multiannual financial framework.............................. 28
Third-party contributions ........................................................................................... 28
Estimated impact on revenue ..................................................................................... 29
DIGITAL DIMENSIONS .......................................................................................... 29
Requirements of digital relevance .............................................................................. 30
Data ............................................................................................................................ 30
Digital solutions ......................................................................................................... 31
Interoperability assessment ........................................................................................ 31
Measures to support digital implementation .............................................................. 32
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1.
1.1.
FRAMEWORK OF THE PROPOSAL/INITIATIVE
Title of the proposal/initiative
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
amending Regulations (EU) No 765/2008, (EU) 2016/424, (EU) 2016/425, (EU)
2016/426, (EU) 2023/1230, (EU) 2023/1542 and (EU) 2024/1781 as regards
digitalisation and alignment of common specifications
1.2.
Policy area(s) concerned
Better Regulation, Competitiveness
1.3.
1.3.1.
Objective(s)
General objective(s)
To support the growth and development of companies, thus increasing their
competitiveness and contribution to European welfare and prosperity.
To promote a favorable business environment and to reduce administrative burdens
for companies, thereby enhancing their ability to innovate, create jobs, and contribute
to economic growth.
1.3.2.
Specific objective(s)
Removing paper format references for declaration of conformity for for
manufactures who have to provide such declarations of conformity under New
Legislative Framework (‘NLF’) directives and regulations,
Introducing possibility for the manufacturer to provide a digital format of the
instructions for use,
To provide alternative options to give businesses legal certainty on compliance with
the EU rules, in situations where harmonised standards do not exist, are not available
or there is an urgent need.
1.3.3.
Expected result(s) and impact
Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted.
The proposal/initiative is expected to have the following effects on the
beneficiaries/groups targeted:
-
reduce burden of paper copies,
-
Reduced administrative burdens: manufacturers will experience a reduction in
administrative burdens, which will enable them to focus on their core business
activities and improve their competitiveness
-
Improved competitiveness: manufacturer will become more competitive, both
domestically and internationally, which will enable them to increase their market
share and contribute to European economic growth
-
Job creation: The growth and development of manufacturers will lead to the
creation of new jobs, which will contribute to reducing unemployment and
promoting social cohesion
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-
Increased innovation: digitalisation of declarations of confirmity, of instruction
will encouraged innovation and create new incentives to invest in data collection and
processing with eGovernment solutions, which will contribute to improving the
overall innovation capacity of the European economy
Target groups:
The proposal/initiative is targeted at the approximately manufacturers active in the
field of the abovementioned directives.
1.3.4.
Indicators of performance
Specify the indicators for monitoring progress and achievements.
N/A
1.4.
The proposal/initiative relates to: None of the below.
a new action
a new action following a pilot project / preparatory action
23
the extension of an existing action
a merger or redirection of one or more actions towards another/a new action
1.5.
1.5.1.
Grounds for the proposal/initiative
Requirement(s) to be met in the short or long term including a detailed timeline for
roll-out of the implementation of the initiative
This proposal concerns two omnibus acts amending EU legislation. It can therefore
only be carried out at EU level.
1.5.2.
Added value of EU involvement (it may result from different factors, e.g.
coordination gains, legal certainty, greater effectiveness or complementarities). For
the purposes of this section 'added value of EU involvement' is the value resulting
from EU action, that is additional to the value that would have been otherwise
created by Member States alone.
N/A
1.5.3.
Lessons learned from similar experiences in the past
N/A
1.5.4.
Compatibility with the multiannual financial framework and possible synergies with
other appropriate instruments
N/A
1.5.5.
Assessment of the different available financing options, including scope for
redeployment
N/A
23
As referred to in Article 58(2), point (a) or (b) of the Financial Regulation.
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1.6.
Duration of the proposal/initiative and of its financial impact
limited duration
–
in effect from [DD/MM]YYYY to [DD/MM]YYYY
–
financial impact from YYYY to YYYY for commitment appropriations and
from YYYY to YYYY for payment appropriations.
unlimited duration
– Implementation with a start-up period from YYYY to YYYY,
– followed by full-scale operation.
1.7.
Method(s) of budget implementation planned
24
Direct management
by the Commission
–
by its departments, including by its staff in the Union delegations;
–
by the executive agencies
Shared management
with the Member States
Indirect management
by entrusting budget implementation tasks to:
–
third countries or the bodies they have designated
–
international organisations and their agencies (to be specified)
–
the European Investment Bank and the European Investment Fund
–
bodies referred to in Articles 70 and 71 of the Financial Regulation
–
public law bodies
–
bodies governed by private law with a public service mission to the extent that
they are provided with adequate financial guarantees
–
bodies governed by the private law of a Member State that are entrusted with
the implementation of a public-private partnership and that are provided with
adequate financial guarantees
–
bodies or persons entrusted with the implementation of specific actions in the
common foreign and security policy pursuant to Title V of the Treaty on
European Union, and identified in the relevant basic act
–
bodies
established in a Member State, governed by the private law of a
Member State or Union law and eligible to be entrusted, in accordance with
sector-specific rules, with the implementation of Union funds or budgetary
guarantees, to the extent that such bodies are controlled by public law bodies or
by bodies governed by private law with a public service mission, and are provided
with adequate financial guarantees in the form of joint and several liability by the
controlling bodies or equivalent financial guarantees and which may be, for each
action, limited to the maximum amount of the Union support.
24
Details of budget implementation methods and references to the Financial Regulation may be found on
the BUDGpedia site:
https://myintracomm.ec.europa.eu/corp/budget/financial-rules/budget-
implementation/Pages/implementation-methods.aspx.
EN
5
EN
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If more than one budget implementation method is indicated, please provide details in the
‘Comments’ section.
Comments
N/A
EN
6
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2.
2.1.
MANAGEMENT MEASURES
Monitoring and reporting rules
Specify frequency and conditions.
N/A
2.2.
2.2.1.
Management and control system(s)
Justification of the budget implementation method(s), the funding implementation
mechanism(s), the payment modalities and the control strategy proposed
N/A
2.2.2.
Information concerning the risks identified and the internal control system(s) set up
to mitigate them
N/A
2.2.3.
Estimation and justification of the cost-effectiveness of the controls (ratio between
the control costs and the value of the related funds managed), and assessment of the
expected levels of risk of error (at payment & at closure)
N/A.
2.3.
Measures to prevent fraud and irregularities
Specify existing or envisaged prevention and protection measures, e.g. from the anti-
fraud strategy.
N/A
EN
7
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3.
3.1.
ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE
Heading(s) of the multiannual financial framework and expenditure budget
line(s) affected
Please note that an Excel tool is available on the BUDGpedia page on the Legislative
Financial and Digital Statement to help you with the calculations. You are strongly
advised to use it to facilitate filling in this template.
Please insert as many budget lines as needed in the two tables below.
•
Existing budget lines
In order of multiannual financial framework headings and budget lines.
Budget line
Type of
expenditure
Contribution
from
candidate
countries
and
potential
candidates
27
Heading of
multiannual
financial
framework
Number
Diff./Non-
diff.
25
from
EFTA
countries
26
From
other
third
countries
other assigned
revenue
N/A
Diff./Non
-diff.
YES/NO
YES/NO
YES/NO
YES/NO
•
New budget lines requested
In order of multiannual financial framework headings and budget lines.
Budget line
Heading of
multiannual
financial
framework
Type of
expenditure
Contribution
from
candidate
countries
and
potential
candidates
Number
Diff./Non-
diff.
from
EFTA
countries
from
other
third
countries
other assigned
revenue
N/A
Diff./Non
-diff.
YES/NO
YES/NO
YES/NO
YES/NO
25
26
27
Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations.
EFTA: European Free Trade Association.
Candidate countries and, where applicable, potential candidates from the Western Balkans.
EN
8
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3.2.
3.2.1.
Estimated financial impact of the proposal on appropriations
Summary of estimated impact on operational appropriations
–
The proposal/initiative does not require the use of operational appropriations
–
The proposal/initiative requires the use of operational appropriations, as explained below
3.2.1.1. Appropriations from voted budget
EUR million (to three decimal places)
Heading of multiannual financial framework
Number
DG: <…….>
Operational appropriations
Year
2024
Commitments
Payments
Commitments
(1a)
(2a)
(1b)
(2b)
Year
2025
Year
2026
Year
2027
TOTAL MFF
2021-2027
Budget line
Budget line
0.000
0.000
0.000
0.000
0.000
0.000
0.000
Year
2024
0.000
0.000
Year
2025
0.000
0.000
Year
2026
0.000
0.000
Year
2027
0.000
0.000
TOTAL MFF
2021-2027
Payments
Appropriations of an administrative nature financed from the envelope of specific programmes
28
Budget line
(3)
TOTAL appropriations
for DG
<…….>
DG: <…….>
Operational appropriations
Budget line
Commitments
Payments
=1a+1b+3
=2a+2b+3
Commitments
(1a)
0.000
28
Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research.
EN
9
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Payments
Commitments
(2a)
(1b)
(2b)
0.000
0.000
0.000
0.000
0.000
0.000
Year
2024
0.000
0.000
Year
2025
0.000
0.000
Year
2026
0.000
0.000
0.000
0.000
0.000
0.000
Year
2027
0.000
0.000
0.000
0.000
TOTAL MFF
2021-2027
0.000
0.000
Budget line
Payments
Appropriations of an administrative nature financed from the envelope of specific programmes
29
Budget line
(3)
TOTAL appropriations
for DG
<…….>
Commitments
Payments
=1a+1b+3
=2a+2b+3
Commitments
(4)
(5)
0.000
0.000
TOTAL
operational
appropriations
Payments
TOTAL appropriations of an administrative nature financed
from the envelope for specific programmes
(6)
0.000
0.000
0.000
0.000
0.000
TOTAL appropriations under
HEADING <….>
of the multiannual financial framework
Commitments
Payments
=4+6
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
=5+6
Heading of multiannual financial
framework
Number
DG: <…….>
Year
2024
Year
2025
Year
2026
Year
2027
TOTAL MFF
2021-2027
29
Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research.
EN
10
EN
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Operational appropriations
Budget line
Budget line
Commitments
Payments
Commitments
Payments
(1a)
(2a)
(1b)
(2b)
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
Appropriations of an administrative nature financed from the envelope of specific programmes
30
Budget line
(3)
TOTAL appropriations
for DG
<…….>
Commitments
Payments
=1a+1b +3
=2a+2b+3
DG: <…….>
Operational appropriations
Year
2024
Commitments
Payments
Commitments
Payments
(1a)
(2a)
(1b)
(2b)
Year
2025
Year
2026
Year
2027
TOTAL MFF
2021-2027
Budget line
Budget line
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
Appropriations of an administrative nature financed from the envelope of specific programmes
31
Budget line
(3)
TOTAL appropriations
for DG
<…….>
Commitments
Payments
=1a+1b +3
=2a+2b+3
Year
2024
30
31
Year
2025
Year
2026
Year
2027
TOTAL MFF
2021-2027
Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research.
Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research.
EN
11
EN
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Commitments
(4)
(5)
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
TOTAL
operational
appropriations
Payments
TOTAL appropriations of an administrative nature financed
from the envelope for specific programmes
(6)
0.000
0.000
0.000
0.000
0.000
TOTAL appropriations under
HEADING <….>
of the multiannual financial framework
Commitments
Payments
=4+6
0.000
0.000
Year
2024
0.000
0.000
Year
2025
0.000
0.000
0.000
0.000
0.000
Year
2026
0.000
0.000
0.000
0.000
0.000
Year
2027
0.000
0.000
0.000
0.000
0.000
TOTAL MFF
2021-2027
0.000
0.000
0.000
=5+6
•
TOTAL operational
operational headings)
appropriations
(all
Commitments
Payments
(4)
(5)
0.000
0.000
0.000
•
TOTAL appropriations of an administrative nature financed
from the envelope for specific programmes (all operational
headings)
(6)
TOTAL appropriations Under
Heading 1 to 6
of the multiannual financial framework
(Reference amount)
Commitments
Payments
=4+6
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
=5+6
Heading of multiannual financial framework
7
‘Administrative expenditure’
32
32
The necessary appropriations should be determined using the annual average cost figures available on the appropriate BUDGpedia webpage
.
EN
12
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This section should be filled in using the 'budget data of an administrative nature' to be firstly inserted in the Annex to the Legislative Financial
and Digital Statement (Annex 5
33
to the Commission Decision on the internal rules for the implementation of the Commission section of the
general budget of the European Union), which is uploaded to DECIDE for interservice consultation purposes.
DG: <…….>
Human resources
Other administrative expenditure
TOTAL DG
<…….>
Year
2024
0.000
0.000
Appropriations
Year
2025
0.000
0.000
0.000
Year
2025
0.000
0.000
0.000
Year
2026
0.000
0.000
0.000
Year
2026
0.000
0.000
0.000
Year
2027
0.000
0.000
0.000
Year
2027
0.000
0.000
0.000
TOTAL
MFF 2021-
2027
0.000
0.000
0.000
TOTAL
MFF 2021-
2027
0.000
0.000
0.000
0.000
Year
2024
0.000
0.000
DG: <…….>
Human resources
Other administrative expenditure
TOTAL DG
<…….>
Appropriations
0.000
(Total
commitments
= Total
payments)
TOTAL appropriations under HEADING 7 of the multiannual financial
framework
0.000
0.000
0.000
0.000
0.000
EUR million (to three decimal places)
Year
2024
Year
2025
Year
2026
Year
2027
TOTAL MFF
2021-2027
TOTAL appropriations under HEADINGS 1 to 7
of the multiannual financial framework
Commitments
Payments
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
33
If you report the use of appropriations under Heading 7, completing Annex 5 is a compulsory requirement
.
EN
13
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3.2.1.2. Appropriations from external assigned revenues
EUR million (to three decimal places)
Heading of multiannual financial framework
Number
DG: <…….>
Operational appropriations
Year
2024
Commitments
Payments
Commitments
(1a)
(2a)
(1b)
(2b)
Year
2025
Year
2026
Year
2027
TOTAL MFF
2021-2027
Budget line
Budget line
0.000
0.000
0.000
0.000
0.000
0.000
0.000
Year
2024
0.000
0.000
Year
2025
0.000
0.000
Year
2026
0.000
0.000
Year
2027
0.000
0.000
TOTAL MFF
2021-2027
Payments
Appropriations of an administrative nature financed from the envelope of specific programmes
34
Budget line
(3)
TOTAL appropriations
for DG
<…….>
DG: <…….>
Operational appropriations
Commitments
Payments
=1a+1b+3
=2a+2b+3
Budget line
Budget line
Commitments
Payments
Commitments
Payments
(1a)
(2a)
(1b)
(2b)
0.000
0.000
0.000
0.000
Appropriations of an administrative nature financed from the envelope of specific programmes
35
34
35
Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research.
Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research.
EN
14
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Budget line
(3)
0.000
0.000
0.000
Year
2024
0.000
0.000
Year
2025
0.000
0.000
Year
2026
0.000
0.000
0.000
0.000
0.000
0.000
Year
2027
0.000
0.000
0.000
0.000
TOTAL MFF
2021-2027
0.000
0.000
TOTAL appropriations
for DG
<…….>
Commitments
Payments
=1a+1b+3
=2a+2b+3
Commitments
(4)
(5)
0.000
0.000
TOTAL
operational
appropriations
Payments
TOTAL appropriations of an administrative nature financed
from the envelope for specific programmes
(6)
0.000
0.000
0.000
0.000
0.000
TOTAL appropriations under
HEADING <….>
of the multiannual financial framework
Commitments
Payments
=4+6
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
=5+6
Heading of multiannual financial framework
Number
DG: <…….>
Operational appropriations
Year
2024
Commitments
Payments
Commitments
Payments
(1a)
(2a)
(1b)
(2b)
Year
2025
Year
2026
Year
2027
TOTAL MFF
2021-2027
Budget line
Budget line
0.000
0.000
0.000
0.000
Appropriations of an administrative nature financed from the envelope of specific programmes
36
36
Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research.
EN
15
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Budget line
(3)
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
TOTAL appropriations
for DG
<…….>
Commitments
Payments
=1a+1b+3
=2a+2b+3
================================================================================================
Optional: if more than one DG is involved in the proposal, please fill in the below tables; if not, please delete them.
DG: <…….>
Operational appropriations
Year
2024
Commitments
Payments
Commitments
Payments
(1a)
(2a)
(1b)
(2b)
Year
2025
Year
2026
Year
2027
TOTAL MFF
2021-2027
Budget line
Budget line
0.000
0.000
0.000
0.000
0.000
0.000
0.000
Year
2024
Year
2025
0.000
0.000
0.000
0.000
Year
2026
0.000
0.000
0.000
0.000
0.000
0.000
Year
2027
0.000
0.000
0.000
0.000
TOTAL MFF
2021-2027
0.000
0.000
Appropriations of an administrative nature financed from the envelope of specific programmes
37
Budget line
(3)
TOTAL appropriations
for DG
<…….>
Commitments
Payments
=1a+1b+3
=2a+2b+3
Commitments
(4)
(5)
0.000
0.000
TOTAL
operational
appropriations
Payments
TOTAL appropriations of an administrative nature financed
from the envelope for specific programmes
(6)
0.000
0.000
0.000
0.000
0.000
37
Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research.
EN
16
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TOTAL appropriations under
HEADING <….>
of the multiannual financial framework
Commitments
Payments
=4+6
0.000
0.000
Year
2024
0.000
0.000
Year
2025
0.000
0.000
0.000
0.000
0.000
Year
2026
0.000
0.000
0.000
0.000
0.000
Year
2027
0.000
0.000
0.000
0.000
0.000
TOTAL MFF
2021-2027
0.000
0.000
0.000
=5+6
•
TOTAL operational
operational headings)
appropriations
(all
Commitments
Payments
(4)
(5)
0.000
0.000
0.000
•
TOTAL appropriations of an administrative nature financed
from the envelope for specific programmes (all operational
headings)
(6)
TOTAL appropriations under Headings 1
to 6
of the multiannual financial framework (Reference
amount)
Commitments
Payments
=4+6
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
=5+6
Heading of multiannual financial framework
7
‘Administrative expenditure’
38
EUR million (to three decimal places)
DG: <…….>
Human resources
Other administrative expenditure
TOTAL DG
<…….>
Year
2024
0.000
0.000
Year
2025
0.000
0.000
0.000
Year
Year
2026
0.000
0.000
0.000
Year
Year
2027
0.000
0.000
0.000
Year
TOTAL
MFF 2021-
2027
0.000
0.000
0.000
TOTAL
Appropriations
0.000
Year
DG: <…….>
38
The necessary appropriations should be determined using the annual average cost figures available on the appropriate BUDGpedia webpage.
EN
17
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2024
2025
0.000
0.000
0.000
2026
0.000
0.000
0.000
2027
0.000
0.000
0.000
Human resources
Other administrative expenditure
TOTAL DG
<…….>
0.000
0.000
Appropriations
MFF 2021-
2027
0.000
0.000
0.000
0.000
(Total
commitments
= Total
payments)
TOTAL appropriations under HEADING 7 of the multiannual
financial framework
0.000
0.000
0.000
0.000
0.000
EUR million (to three decimal places)
Year
2024
Year
2025
Year
2026
Year
2027
TOTAL MFF
2021-2027
TOTAL appropriations under HEADINGS 1 to 7
of the multiannual financial framework
Commitments
Payments
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
3.2.2.
Estimated output funded from operational appropriations (not to be completed for decentralised agencies)
Commitment appropriations in EUR million (to three decimal places)
Year
2024
Year
2025
Year
2026
Year
2027
OUTPUTS
Avera
ge
cost
Enter as many years as necessary to show the
duration of the impact (see Section1.6)
TOTAL
Indicate
objectives and
outputs
No
No
No
No
No
No
Cost
Cost
Cost
Cost
Cost
Cost
No
Type
39
Cost
Total
No
Total
cost
SPECIFIC OBJECTIVE No 1
40
…
39
Outputs are products and services to be supplied (e.g. number of student exchanges financed, number of km of roads built, etc.).
EN
18
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- Output
- Output
- Output
Subtotal for specific objective No 1
SPECIFIC OBJECTIVE No 2 ...
- Output
Subtotal for specific objective No 2
TOTALS
40
As described in Section 1.3.2. ‘Specific objective(s)’
EN
19
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3.2.3.
Summary of estimated impact on administrative appropriations
–
The proposal/initiative does not require the use of appropriations of an
administrative nature
–
The proposal/initiative requires the use of appropriations of an administrative
nature, as explained below
3.2.3.1. Appropriations from voted budget
VOTED APPROPRIATIONS
HEADING 7
Human resources
Other administrative expenditure
Subtotal HEADING 7
Outside HEADING 7
Human resources
Other expenditure of an administrative nature
Subtotal outside HEADING 7
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
Year
2024
Year
2025
Year
2026
Year
2027
TOTAL
2021 - 2027
TOTAL
0.000
0.000
0.000
0.000
0.000
========================================================
===========3.2.3.2. Appropriations from external assigned revenues
EXTERNAL ASSIGNED REVENUES
HEADING 7
Human resources
Other administrative expenditure
Subtotal HEADING 7
Outside HEADING 7
Human resources
Other expenditure of an administrative nature
Subtotal outside HEADING 7
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
Year
2024
Year
2025
Year
2026
Year
2027
TOTAL
2021 - 2027
TOTAL
0.000
0.000
0.000
0.000
0.000
3.2.3.3. Total appropriations
TOTAL
VOTED APPROPRIATIONS
+
EXTERNAL ASSIGNED REVENUES
HEADING 7
Human resources
Other administrative expenditure
Subtotal HEADING 7
Outside HEADING 7
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
Year
2024
Year
2025
Year
2026
Year
2027
TOTAL
2021 -
2027
EN
20
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Human resources
Other expenditure of an administrative nature
Subtotal outside HEADING 7
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
TOTAL
0.000
0.000
0.000
0.000
0.000
The appropriations required for human resources and other expenditure of an administrative nature
will be met by appropriations from the DG that are already assigned to management of the action
and/or have been redeployed within the DG, together, if necessary, with any additional allocation
which may be granted to the managing DG under the annual allocation procedure and in the light of
budgetary constraints.
3.2.4.
Estimated requirements of human resources
–
The proposal/initiative does not require the use of human resources
–
The proposal/initiative requires the use of human resources, as explained
below
3.2.4.1. Financed from voted budget
Estimate to be expressed in full-time equivalent units (FTEs)
41
Year
2024
0
0
0
0
0
VOTED APPROPRIATIONS
Establishment plan posts (officials and temporary staff)
20 01 02 01 (Headquarters and Commission’s Representation Offices)
20 01 02 03 (EU Delegations)
01 01 01 01 (Indirect research)
01 01 01 11 (Direct research)
Other budget lines (specify)
•
External staff (inFTEs)
20 02 01 (AC, END from the ‘global envelope’)
20 02 03 (AC, AL, END and JPD in the EU Delegations)
Admin. Support
line
[XX.01.YY.YY]
- at Headquarters
- in EU Delegations
Year
2025
0
0
0
0
0
Year
2026
0
0
0
0
0
Year
2027
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
01 01 01 02 (AC, END - Indirect research)
01 01 01 12 (AC, END - Direct research)
Other budget lines (specify) - Heading 7
Other budget lines (specify) - Outside Heading 7
TOTAL
3.2.4.2. Financed from external assigned revenues
EXTERNAL ASSIGNED REVENUES
Establishment plan posts (officials and temporary staff)
Year
2024
Year
2025
Year
2026
Year
2027
41
Please specify below the table how many FTEs within the number indicated are already assigned to the
management of the action and/or can be redeployed within your DG and what are your net needs.
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20 01 02 01 (Headquarters and Commission’s Representation Offices)
20 01 02 03 (EU Delegations)
01 01 01 01 (Indirect research)
01 01 01 11 (Direct research)
Other budget lines (specify)
•
External staff (in full time equivalent units)
20 02 01 (AC, END from the ‘global envelope’)
20 02 03 (AC, AL, END and JPD in the EU Delegations)
Admin. Support
line
[XX.01.YY.YY]
- at Headquarters
- in EU Delegations
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
01 01 01 02 (AC, END - Indirect research)
01 01 01 12 (AC, END - Direct research)
Other budget lines (specify) - Heading 7
Other budget lines (specify) - Outside Heading 7
TOTAL
3.2.4.3. Total requirements of human resources
TOTAL VOTED APPROPRIATIONS
+
EXTERNAL ASSIGNED REVENUES
Establishment plan posts (officials and temporary staff)
20 01 02 01 (Headquarters and Commission’s Representation Offices)
20 01 02 03 (EU Delegations)
01 01 01 01 (Indirect research)
01 01 01 11 (Direct research)
Other budget lines (specify)
•
External staff (in full time equivalent units)
20 02 01 (AC, END from the ‘global envelope’)
20 02 03 (AC, AL, END and JPD in the EU Delegations)
Admin. Support
line
[XX.01.YY.YY]
- at Headquarters
- in EU Delegations
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Year
2024
Year
2025
Year
2026
Year
2027
01 01 01 02 (AC, END - Indirect research)
01 01 01 12 (AC, END - Direct research)
Other budget lines (specify) - Heading 7
Other budget lines (specify) - Outside Heading 7
TOTAL
===================================================================
Based on the detailed description in Annex V to the LFDS
42
, the above tables should be accompanied
by either of the below clarifications, depending on the option.
42
For the purpose of estimating workload and staff needs, you may use the guidance on workload
assessment prepared by DG HR.
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Option 1: The additional human resources required for this proposal are fully covered by
redeployments within the DG/service or exceptionally, from redeployments from the limited
Commission redeployment pool, following the internal process applicable to that end. The duly
justified clarification shall accompany the tables above and below. [Please refer to the Annex to the
LFDS to identify redeployments within the DGs as clearly as possible]. If this option is applicable, the
following comment should be included:
[Considering the overall strained situation in Heading 7, in terms of both staffing and the level of
appropriations, the human resources required will be met by staff from the DG who are already
assigned to the management of the action and/or have been redeployed within the DG or other
Commission services.]
Option 2: Exceptionally, if internal redeployments within the implementing DGs appear for duly
substantiated reasons impossible or insufficient, the proposal may require additional human resources.
The latter will be paid as appropriate
43
from an administrative support line of the programme/initiative
or by a fee as external assigned revenue.
In this case, please specify the type of staff by filling in the below table.
Please specify how many of the staff requested for the initiative are already in place in the DG/service
(current staff) and how many additional staff are requested (in the column corresponding to the type of
budget from which they are to be financed).
Please fill in the table to illustrate this for staff at ‘cruising speed’ level.
The staff required to implement the proposal (in FTEs):
To be covered by
current staff
available in the
Commission
services
Exceptional additional staff*
To be financed
under Heading 7
or Research
Establishment
plan posts
External
staff
(CA, SNEs, INT)
To be financed
from BA line
To be financed
from fees
N/A
Description of tasks to be carried out by:
Officials and temporary staff
External staff
3.2.5.
Overview of estimated impact on digital technology-related investments
Compulsory: the best estimate of the digital technology-related investments entailed
by the proposal/initiative should be included in the table below.
43
Please note that such exception needs to be agreed with central services before the launch of the ISC.
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Exceptionally, when required for the implementation of the proposal/initiative, the
appropriations under Heading 7 should be presented in the designated line.
The appropriations under Headings 1-6 should be reflected as “Policy IT expenditure
on operational programmes”. This expenditure refers to the operational budget to be
used to re-use/ buy/ develop IT platforms/ tools directly linked to the implementation
of the initiative and their associated investments (e.g. licences, studies, data storage
etc). The information provided in this table should be consistent with details
presented under Section 4 “Digital dimensions”.
Year
TOTAL Digital and IT appropriations
2024
HEADING 7
Year
2025
Year
2026
Year
2027
TOTAL
MFF
2021 -
2027
IT expenditure (corporate)
Subtotal HEADING 7
Outside HEADING 7
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
Policy IT expenditure on operational
programmes
Subtotal outside HEADING 7
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
TOTAL
0.000
0.000
0.000
0.000
0.000
3.2.6.
Compatibility with the current multiannual financial framework
The proposal/initiative:
–
can be fully financed through redeployment within the relevant heading of the
multiannual financial framework (MFF)
– N/A
requires use of the unallocated margin under the relevant heading of the
MFF and/or use of the special instruments as defined in the MFF Regulation
N/A
–
requires a revision of the MFF
N/A
3.2.7.
Third-party contributions
The proposal/initiative:
–
does not provide for co-financing by third parties
–
provides for the co-financing by third parties estimated below:
Appropriations in EUR million (to three decimal places)
Year
2024
Year
2025
Year
2026
Year
2027
Total
Specify the co-financing body
TOTAL appropriations co-
financed
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3.3.
Estimated impact on revenue
–
The proposal/initiative has no financial impact on revenue.
–
The proposal/initiative has the following financial impact:
–
–
–
on own resources
on other revenue
please indicate, if the revenue is assigned to expenditure lines
EUR million (to three decimal places)
Appropriations
available for the
current financial
year
Impact of the proposal/initiative
44
Year
2024
Year
2025
Year
2026
Year
2027
Budget revenue line:
Article ………….
For assigned revenue, specify the budget expenditure line(s) affected.
N/A
Other remarks (e.g. method/formula used for calculating the impact on revenue or
any other information).
N/A
4.
DIGITAL DIMENSIONS
When completing this Section, it is acceptable to present the information in a table format,
where appropriate.
4.1.
•
•
•
•
•
•
Requirements of digital relevance
Reference: Article 1(1), Article 2 (1a, 1c) and other
High-level descrittion: Definition of ‘digital contact’: any up-to-date and accessible
online communication channel
Stakeholders: Economic Operators, Consumers and othe End-users, Member States
Authorities.
High-level processes: Market surveillance verification and monitoring.
Reference: Article 1 (2)(3)(4)(5) and other
High-level description: the products must be accompanied by the internet address or
machine-readable code through which the EC declaration of conformity can be
accessed.
Stakeholders: Economic Operators, Member States Authorities.
As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net
amounts, i.e. gross amounts after deduction of 20% for collection costs.
Requirement 1:
Requirement 2:
•
44
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25
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•
•
•
•
•
•
•
High-level processes: Market surveillance verification and monitoring.
Reference: Article 1(6)(a), Article 2(2a) and other
High-level description: Definition of EC declaration of conformity, in electronic
form.
Stakeholders: Economic Operators, Member States Authorities.
High-level processes: Market surveillance verification and monitoring.
Reference: Article 1(6)(b) and other
High-level description: include the information that the product complies with the
requirements set out in that legislation in a digital product passport or to upload the
EC declaration of conformity or instructions in a digital product passport.
Stakeholders: Economic Operators, Member States Authorities.
High-level processes: Market surveillance verification and monitoring
Reference: Article 1 (7)(a) and other
High-level description: Member States shall ensure that the Commission and any
other Member State may, on a reasoned request, obtain all information, in electronic
form.
Stakeholders:
Commission.
Economic
Operators,
Member
States
Authorities,
European
Requirement 3:
Requirement 4:
•
•
•
•
Requirement 5:
•
•
•
•
High-level processes: conformity assessment procedure
Reference: Article 1(7b) and other
High-level description: Where appropriate, the manufacturer shall provide the
notified body carrying out the conformity assessment procedure with all the
information and documentation relating to conformity assessment procedures in
electronic form.
Stakeholders: Notified Bodies, Economic Operators
High-level processes: Conformity assessment procedures
Reference: Article 2 (1b) and other
High-level description: ‘a common specification’ can be digital or structured in a
manner that can facilitate interoperability.
Stakeholders: European Commission, Economic Operators, Notified Bodies, Market
Surveillance Authorities.
High-level processes: Conformity assessment procedures, Market surveillance
verification and monitoring.
Requirement 6:
•
•
•
•
•
•
Requirement 7:
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26
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Requirement 8:
•
•
Reference: Article 3(2) and other
High-level description: The instructions and safety information may be provided in
electronic form. It could be further specified that the format should comply with the
accessibility requirements.
Stakeholders: Economic Operators, Consumers and other End-users, Market
surveillance authorities
•
4.2.Data
The definition “electronic form” allows plain text files, PDF files, Microsoft Word
Documents, Web pages. While this is an improvement compared to the paper format,
interoperability can be further improved by using a format which allows interconnection of
IT systems.
4.3.Digital solutions
N/A
4.4. Interoperability assessment
Digital public service:
Market surveillance monitoring/verification/investigations.
Certification services.
Legal layer interoperability:
Further interoperability can be achieved with the revision of
the NLF.
Semantic layer potential barrier:
The structure of the digital contact, EU declaration of
conformity and common specifications could be better defined.
Technical interoperability potential barrier:
The “electronic form” definition can hinder
interoperability because it is possible to use formats which are not interoperable, like
websites, unstructured word documents and PDF files, even videos or photos.
4.5. Measures to support digital implementation
The revision of the NLF and the Digital Product Passport Implementing Acts will take into
consideration all digital requirements for further interoperability in all processes in scope of
this directive. Particular attention will be paid to the cybersecurity aspects.
The Commission will ensure that the common specifications are defined in the
implementing acts in a structured manner, to allow interoperability. The verification and
certification processes could be further defined to allow automatisation and require
measures to address cybersecurity possible threats.
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