EU of the European Parliament and of the Council as regards digitalisation and common specifications - Main contents

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This page contains a limited version of this dossier in the EU Monitor.

dossier	COM(2025)503 - Amendment of Directives 2000/14/EC, 2011/65/EU, 2013/53/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, ...
source	COM(2025)503
date	21-05-2025

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. ²

The Communication ‘A Competitiveness Compass for the EU’ ³ 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

However, there are still various pieces of EU legislation that provide for the use of paper format.

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 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.

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 surveillances authorities expect those instructions to be in paper format and therefore impose this format on manufacturers.

The Blue Guide ⁴ provides detailed explanations on EU product rules.

Taking into account that in 2024, no less than 94% of EU households had access to internet ⁵ , the paper format of instructions for use accompanying products under the scope of the Directives is outdated and not aligned with current technologies, consumer habits or green objectives.

Consequently, manufacturers should be able to choose a 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 purchase.

Streamlining reporting obligations, reducing administrative burdens and promoting digitalisation are priorities. In this context, the present proposal aims to simplify initiatives included in the headline ambition ‘A new plan for Europe’s sustainable prosperity and competitiveness’ 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 seek 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 existing 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 more 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 Directive 2000/14/EC on the noise emission in the environment by equipment for use outdoors, ⁶ Directive 2010/35/EU on transportable pressure equipment, ⁷ Directive 2011/65/EU on restriction of hazardous substances in electrical and electronic equipment, ⁸ Directive 2013/53/EU on recreational craft and personal watercraft, ⁹ Directive 2014/29/EU on simple pressure vessels, ¹⁰ Directive 2014/30/EU on electromagnetic compatibility, ¹¹ Directive 2014/31/EU on non-automatic weighing instruments, ¹² Directive 2014/32/EU on measuring instruments, ¹³ Directive 2014/33/EU on lifts and safety components for lifts, ¹⁴ Directive 2014/34/EU on equipment and protective systems intended for use in potentially explosive atmospheres, ¹⁵ Directive 2014/35/EU on electrical equipment designed for use within certain voltage limits, ¹⁶ Directive 2014/53/EU on radio equipment, ¹⁷ Directive 2014/68/EU on pressure equipment ¹⁸ and Directive 2014/90/EU on marine equipment ¹⁹ by a combination of measures.

Additionally, the proposal will align the existing fall-back option to harmonised standards uniformly in Directive 2011/65/EU on restriction of hazardous substances in electrical and electronical equipment, Directive 2013/53/EU on recreational craft and personal watercraft, Directive 2014/29/EU on simple pressure vessels, Directive 2014/30/EU on electromagnetic compatibility, Directive 2014/31/EU on non-automatic weighing instruments, Directive 2014/32/EU on measuring instruments, Directive 2014/33/EU on lifts, Directive 2014/34/EU on ATEX, Directive 2014/35/EU on low voltage, Directive 2014/53/EU on radio equipment, and Directive 2014/68/EU on pressure equipment.

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 step in a continuous process of looking comprehensively at existing reporting requirements, with a view to assessing their continued relevance and to making them more efficient.

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.

- Furthermore, in cases where harmonised standards are not available, common specifications will be accepted, ensuring consistency with existing legislative provisions in certain sectoral policy area 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 are essential, they need to be as efficient as possible, avoiding overlaps, removing unnecessary burdens and using digital and interoperable solutions as much as possible.

The current proposals rationalise reporting requirements thus making 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 Directive 2000/14/EC on the noise emission in the environment by equipment for use outdoors, Directive 2011/65/EU on restriction of hazardous substances in electrical and electronic equipment, Directive 2013/53/EU on recreational craft and personal watercraft, Directive 2014/29/EU on simple pressure vessels, Directive 2014/30/EU on electromagnetic compatibility, Directive 2014/31/EU on non-automatic weighing instruments, Directive 2014/32/EU on measuring instruments, Directive 2014/33/EU on lifts and safety components for lifts, Directive 2014/34/EU on equipment and protective systems intended for use in potentially explosive atmospheres, Directive 2014/35/EU on electrical equipment designed for use within certain voltage limits, Directive 2014/53/EU on radio equipment, Directive 2014/68/EU on pressure equipment and Directive 2014/90/EU on marine equipment.

The Union sectoral frameworks laid down by the above-mentioned Directives 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 the compliance with these requirements.

Another 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 ²⁰ 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 and market surveillance relating to the marketing of products ²¹ , which sets out the principles of the CE marking and accreditations of conformity assessment bodies.

Thanks to the NLF, all the above-mentioned pieces of legislation affected by this proposal contain provisions of a similar type. The legislative acts in question are aligned with the NLF, with the exception of Directive 2000/14/EC, 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.

The marine equipment sector has unique requirements for ensuring safety on board EU ships, which are reflected in Directive 2014/90/EU. As a result, this Directive has specific rules that differ from other legislation aligned with the NLF. One such rule is the requirement for a paper copy of the declaration of conformity to be kept on board an EU ship until the marine equipment is removed. However, the European Maritime Safety Agency's database available to Member State flag states and market surveillance authorities is suitable for electronic interaction and requires the adaptation of this requirement to the digital age. By uploading a copy of the declaration of conformity to this database, the necessary checks and controls of the marine equipment on the ship can be carried out electronically. This approach will also help ensure uniform application and practices under this legislation, streamlining the process and reducing administrative burdens.

Amending the above-mentioned Directives in the proposed manner, i.e. removing paper-based obligations and transitioning to digital equivalents, will contribute to the digitalisation of business-to-authority reporting, facilitate the digitalisation of and economic operators’ obligations and reporting procedures, 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 and economic operators’ obligations simplify 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.

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 directives to be amended by this act, namely Directive 2000/14/EC on the noise emission in the environment by equipment for use outdoors, Directive 2011/65/EU on restriction of hazardous substances in electrical and electronic equipment, Directive 2013/53/EU on recreational crafts Directive 2014/29/EU on simple pressure vessels, Directive 2014/30/EU on electromagnetic compatibility, Directive 2014/31/EU on non-automatic weighing instruments, Directive 2014/32/EU on measuring instruments, Directive 2014/33/EU on lifts and safety components for lifts, Directive 2014/34/EU on equipment and protective systems intended for use in potentially explosive atmospheres, Directive 2014/35/EU on electrical equipment designed for use within certain voltage limits, Directive 2014/53/EU on radio equipment, Directive 2014/68/EU on pressure equipment and Directive 2014/90/EU on marine equipment are harmonised pieces of product legislation under the Single Market rules, and most of them are aligned with the NLF.

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.

The directives to be amended by this act as regards alignment of common specifications provision, namely Directive 2000/14/EC on the noise emission in the environment by equipment for use outdoors, Directive 2011/65/EU on restriction of hazardous substances in electrical and electronic equipment, Directive 2013/53/EU on recreational crafts, Directive 2014/29/EU on simple pressure vessels, Directive 2014/30/EU on electromagnetic compatibility, Directive 2014/31/EU on non-automatic weighing instruments, Directive 2014/32/EU on measuring instruments, Directive 2014/33/EU on lifts and safety components for lifts, Directive 2014/34/EU on equipment and protective systems intended for use in potentially explosive atmospheres, Directive 2014/35/EU on electrical equipment designed for use within certain voltage limits, Directive 2014/53/EU on radio equipment, Directive 2014/68/EU on pressure equipment and Directive 2014/90/EU on marine equipment, are harmonised pieces of product legislation under the single market rules, and contain the concept of harmonised standards and presumption of conformity.

In conclusion, this omnibus proposal is considered appropriate and efficient due to its ability to adapt the concerned legislation concerned 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, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS

• Ex-post evaluations/fitness checks of existing legislation

1. 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 believed 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 as 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 digital instructions of use as a 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).

In parallel, a written consultation has been 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 of simplifying reporting requirements and ensuring the digitalisation and alignment of common specifications. They are based on experience gained from implementing legislation. The changes do not have significant impact on the policy, but only ensure a more efficient and effective implementation also through aligning common specifications with standing legislation.

• Regulatory fitness and simplification

This is a REFIT proposal, aiming to simplify legislation and cut burdens for stakeholders.

• Fundamental rights

2. N/A

4. BUDGETARY IMPLICATIONS

3. N/A

5. OTHER ELEMENTS

• Implementation plans and monitoring, evaluation and reporting arrangements

4. N/A

• Explanatory documents (for directives)

Considering the scope of the proposal, it is not justified or proportional to require explanatory documents.

• 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 products placed on the market 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”;

–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 another Union legislation that requires the use of such a digital product passport.

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