Considerations on 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, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU and 2014/90/EU of the European Parliament and of the Council as regards digitalisation and common specifications - Main contents
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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, ... |
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document | COM(2025)503 ![]() |
date | May 21, 2025 |
(2) In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’, 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.
(3) In its Better Regulation Guidelines, 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.
(4) 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 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 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, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU and 2014/90/EU of the European Parliament and of the Council (‘the Directives concerned’). Most of the Directives are based on the principles of the ‘new approach’ to technical harmonisation and are also aligned to the reference provisions laid down by Decision No 768/2008/EC of the European Parliament and of the Council.
(6) In accordance with the Directives concerned, manufacturers are to draw up an EU declaration of conformity stating that the fulfilment of essential requirements set out in the applicable Directives has been demonstrated. In order to enable seamless electronic processes, the EU declaration of conformity should be drawn up only in electronic form.
(7) Moreover, Directives 2000/14/EC, 2013/53/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU and 2014/53/EU require that a copy of the EU 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 accompany the product in electronic form. The manufacturer should therefore make sure that the EU declaration of conformity is accessible through an internet address or a machine-readable code.
(8) Taking into account that in 2024 no less than 94% of EU households had access to internet, the paper format of the instructions for use accompanying the products under the scope of the Directives concerned is outdated and is 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 Directives. This will allow manufacturers to 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) Directive 2014/53/EU provides for the possibility for manufacturers to provide a simplified EU declaration of conformity in an electronic form. Considering that this proposal is introducing a digital by default format of the EU declaration of conformity, the provisions on the simplified EU declaration of Conformity become redundant. It is therefore necessary to remove such provisions from Directive 2014/53/EU.
(10) 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 Directives.
(11) The Directives concerned require that economic operators provide, on a reasoned request from a competent national authority or the European Commission, all information and documentation necessary to demonstrate the conformity of the concerned products with the respective Directives, 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.
(12) Directive 2014/90/EU contains certain sectoral specificities, including the unique requirements for ensuring the safety of marine equipment on board EU ships. Due to those specificities, that Directive differs from other NLF-aligned legislation. Specifically, it foresees the obligation for a paper copy of the declaration of conformity to be on board an EU ship until the marine equipment is removed. However, given the availability of the European Maritime Safety Agency’'s database to Member State flag states and market surveillance authorities, the obligation should be satisfied by uploading a copy of the declaration of conformity to this database. This would enable the necessary checks and controls of the marine equipment on the ship to be carried out electronically and ensure uniform application and practices under this legislation.
(13) The current Union standardisation framework which is based on Regulation (EU) No 1025/2012 of the European Parliament and of the Council represents the framework by default to elaborate standards that provide for a presumption of conformity with the relevant essential health and safety requirements or with 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.
(14) As the digital product passport is foreseen in certain Union legislations, such as Regulation (EU) 2023/1542 of the European Parliament and of the Council, it is essential to require the economic operators to store the information contained in the EU declaration of conformity and instructions for use in the digital product passport where a product is covered by multiple pieces of legislation. 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 aligns with the principle that where several pieces of Union harmonisation legislation apply to a product, the manufacturer or any other economic operator, where appropriate, should provide a single EU declaration of conformity.
(15) Since the objectives of this Directive cannot be sufficiently achieved by the Member States as this Directive amends Directives which are harmonising products legislations but can rather, by reason of harmonisation of EU applicable rules, be better 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 Directive does not go beyond what is necessary in order to achieve those objectives.
(16) In order to enable economic operators to supply stock of products that have been placed on the market before the date of application of the national measures transposing this Directive, 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 the Directives concerned before the date of application of the national measures transposing this Directive.
(17) To ensure a smooth and effective transition, to minimize disruptions, and to provide a reasonable timeframe for industries to adjust to the new requirements, application of transposition measures concerning digitalisation should be deferred.
(18) 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, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU and 2014/90/EU should therefore be amended accordingly.