Proposal for a regulation of the European Parliament and of the Council amending Regulations (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

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,

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. The overall costs of reporting are balanced by the benefits they bring, in particular for ensuring compliance with key policy measures. However, in order to ensure that they fulfil their intended purpose and to limit the administrative burden, it is important to streamline those requirements.

(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, harmonisation 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 or require an excessive burden for the economic operators. 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. A smooth transition should be pursued.

(4a) The Commission and the Member States are encouraged to provide guidance and practical support, and to promote the development of streamlined and standardised digital tools, with a view to facilitating the digital transition of companies, in particular SMEs and micro-enterprises.

(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, (EU) 2016/425, (EU) 2016/426, (EU) 2023/1230, (EU) 2023/1542 and (EU) 2024/1781 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.

(6) 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.

(7) 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 ▌ accompany the product in electronic form. The manufacturer should therefore ensure that the EU declaration of conformity is directly accessible through an internet address or a machine-readable code meaning that intermediate steps, such as the number of landing pages, should be minimised as much as possible. Such a direct access should be free of charge, without the need for login procedures, providing any personal data, downloading or using additional applications specific to the economic operator or the obligation to register solely to access the EU declaration of conformity.

(8) Taking into account that in 2024 no less than 94% of EU households had access to internet, the availability of product instructions in digital format offers an opportunity to align with current technologies and contribute to green objectives. In light of this, the possibility for a digital format of the instructions should be introduced in the 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, specific safeguards for consumers should ensure that they, as non-professional users, are still able to access and understand the information, in contrast to professional users, who are expected to possess the expertise and knowledge necessary for the correct use and handling of products. In that spirit, where a product is used solely by professional users, namely persons acquiring the product as professional end-users in the course of their industrial or professional activities, safety information, including instructions that have an impact on the safe use of the product, might be provided in digital format. In contrast, the safety information should always be provided in paper format or marked on the product where it is reasonably foreseeable that a product, even if primarily intended for professional use, could also be used by consumers. 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.

(8a) The definition of ‘consumer’ forms part of the notion of ‘end user’ as laid down in Regulation (EU) 2019/1020 of the European Parliament and of the Council, which applies to the Regulations concerned, and refers to any natural person acting for purposes outside their trade, business, craft or profession. This requirement ensures that all consumers, including vulnerable consumers such as elderly persons, persons with disabilities or those with limited digital literacy, are able to access and understand the safety information.

(8b) Regulation (EU) 2016/425 contains certain sectoral specificities. In order to protect the safety of consumers, where the product is intended for, or can be reasonably foreseen to be used by, consumers, all the instructions and information set out in point 1.4 of Annex II, which are related to the safe use of the product, should be provided in a paper format or made visible on the packaging.

(8c) In order to ensure that all consumers, including those who may not have regular access to digital tools, can effectively exercise their right to obtain the instructions or safety information in paper format, manufacturers may still provide additional accessible means of communication for submitting such requests, including by telephone. This is particularly important for elderly consumers and other groups at risk of digital exclusion. End-users should also be clearly informed, in the safety information accompanying the product, of their right to request the instructions or safety information in paper format.

(8d) Manufacturers should, where relevant, ensure that instructions and safety information provided in digital format take into account the requirements set out in Annex I of Directive (EU) 2019/882 of the European Parliament and of the Council, insofar as the products fall within the scope of that Directive, so that all end-users, including persons with disabilities, are able to access, understand and use the safety information and instructions. Other categories, such as elderly persons or persons with limited digital literacy, may also benefit from these provisions.

(8e) Manufacturers can offer alternative means to deliver the instructions on paper directly to the end-user, free of charge and without imposing any obligation on distributors which are not required to print the instructions, unless they choose to do so voluntarily.

(8f) When providing the instructions and safety information in electronic form, the manufacturer should ensure that those instructions and safety information are directly accessible through an internet address or a machine-readable code, meaning that intermediate steps, such as the number of landing pages, should be minimised as much as possible. Such a direct access should be free of charge, without the need for login procedures, providing any personal data, downloading or using additional applications specific to the economic operator or the obligation to register solely to access the instructions and safety information. This is in line with the overarching vision of digital inclusion, as set out in the European Declaration on Digital Rights and Principles for the Digital Decade, notably chapter II on Solidarity and inclusion.

(8g) Given the shift towards digital information for consumers, when evaluating the implementation of the Regulations amended by this Regulation, where appropriate, the Commission should also assess whether the provisions concerning instructions in digital format are effectively ensuring that such information remains easily accessible and comprehensible for consumers.

(8h) The possibility for the end-user to request the instructions or safety information in paper format should not preclude manufacturers from providing supplementary information materials in an electronic-only format, such as video or audio content, which cannot be reproduced in a paper format. The same content should be provided in paper format and in the materials provided in electronic format.

(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 digital contact should allow consumers and competent authorities to contact economic operators directly, and should be accessible free of charge, without the need for login procedures, provide any personal data, download or use additional applications specific to the economic operator or the obligation to register solely to contact the economic operator. Such digital contact may include, for example, an email address or a contact form on a website, or any other direct means of digital communication without intermediate steps which allow for traceability of exchanges and should be interpreted in a technologically neutral manner. However, it should not be understood as encompassing automatic replies to queries, chatbots, fax numbers, or telephone lines.

(9a) The term ‘digital contact’, similarly to the term ‘electronic address’ in Regulation (EU) 2023/988 of the European Parliament and of the Council, should be interpreted in a technologically neutral manner, capable of evolving with future technological developments, and should cover all forms of direct digital communication.

(10) The Regulations concerned require that economic operators provide, upon 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 becoming less important, 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, in particular SMEs, 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.

(11) 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 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. Several legislative acts already contain such an option to provide businesses with legal predictability and prove compliance with Union law, to cater for such situations. Compliance with common specifications remains purely voluntary for manufacturers, who may rely on them to benefit from a presumption of conformity or choose other appropriate methods to demonstrate compliance with Union requirements.

(11a) Where the lack of cooperation by international standardisation organisations prevents European standardisation organisations from adopting relevant international standards as harmonised standards, and where such situation cannot be adequately mitigated by alternative measures, implementing powers should be conferred on the Commission to adopt, as a measure of last resort, common specifications without prior request to one or more European standardisation organisations to draft or to revise harmonised standards. In view of the upcoming revision of the standardisation regulation, it is appropriate to limit the scope of the last resort clause to a limited period of time. When the Commission drafts such implementing acts, all relevant information concerning the third parties contracted for supporting the drafting process of the implementing act should be made public in a timely manner.

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(12) As the digital product passport is foreseen in certain Union legislation, such as Regulation (EU) 2023/1542 of the European Parliament and of the Council, 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. This approach would reduce the administrative burden on manufacturers, as they would no longer need to maintain separate storage locations for compliance documents, such as declarations of conformity required under the various pieces of product legislation that may apply to the same product, thereby upholding the principle of a single declaration of conformity. In addition, instructions provided in electronic form would be stored together with the declaration of conformity. 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.

(12a) To ensure regulatory continuity and to allow sufficient time for the adoption of certain acts identified under Article 79 of Regulation (EU) 2024/1781 of the European Parliament and of the Council, it is appropriate to prolong the validity of the transitional continued application of certain provisions of Directive 2009/125/EC until 31 December 2028. This will also support a coherent and effective transition towards the new digital instruments established under the Regulation, in particular the Digital Product Passport.

(12b) The extension of the transitional continued application of certain provisions of Directive 2009/125/EC should not prevent the Commission from incorporating, where technically feasible, information requirements and data transparency objectives available through the digital product passport in accordance with the Regulation (EU) 2024/1781 [ESPR] into the pending implementing measures.

(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.

(14) To ensure a smooth and effective transition, to minimize disruptions, and to provide a reasonable timeframe for industries to adjust to the new requirements, the application of the amendments to Regulations (EU) ▌ 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009, (EU) 2023/1230, (EU) 2023/1542 and (EU) 2024/1781 concerning digitalisation should be deferred. ▌

(15) 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) ▌ 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2023/1230, (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.

(16) Regulations ▌ (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 ▌ , (EU) 2023/1230, (EU) 2023/1542 and (EU) 2024/1781 should therefore be amended accordingly,

HAVE ADOPTED THIS REGULATION:

▌

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 freely accessible online communication channel such as email addresses through which economic operators can be contacted without the need to register or to download or use additional applications specific to the economic operator;’

(b) the following point (19a) is inserted:

‘(19a) ‘common specification’ means a ▌ technical specification, other than a standard, that provide means of complying with the essential requirements set out in Annex II applicable to a subsystem or safety component;’

(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 as referred to in Article 19, in electronic form, and affix the CE marking referred to in Article 20. ’

(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 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 contacted.;’

(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 directly accessed and by the instructions and safety information, in a language which can be easily understood by 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 user of the subsystem or the safety component when deciding the specific format for the instructions and safety information. When drafting instructions and the safety information, the manufacturers shall take account of the intended use and foreseeable misuse by the 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 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 directly accessed.

When the instructions and safety information, 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 directly access them and how to request them in paper format;

(b) present them in a format that makes it possible for the user to print and download the instructions and safety information and save them on an electronic device so that the 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 and safety information 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 user may, at time of the purchase of the subsystem or the safety component, or up to 24 months after that purchase, request the instructions or safety information in paper format. Where the user requests those instructions or safety information, the manufacturer shall provide them to the user, free of charge, within one month of receiving the request.; The safety information shall clearly inform the user of their right to request the instructions in paper format.;’

(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:

‘(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 directly 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 directly accessed and by the instructions and safety information in accordance with Article 11(7) 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

1. The Commission may adopt implementing acts establishing common specifications that provide a means to comply with the essential requirements set out in Annex II. Those implementing acts shall only be adopted where the following conditions are fulfilled:

(a) there is no harmonised standard covering those requirements the reference of which is published in the Official Journal of the European Union and no such reference is expected to be published within a reasonable period;

(b) the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft or to revise European standards for those requirements; and:

(i) the request has not been accepted by any of the European standardisation organisations to which the request was addressed; or

(ii) the request has been accepted by at least one of the European standardisation organisations to which the request was addressed, but the European standards requested:

(1) are not delivered within the deadline set in the request;

(2) do not comply with the request; or

(3) do not satisfy the requirements they aim to cover.

▌

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(3).

1a. In exceptional cases where the lack of cooperation by international standardisation organisations prevents European standardisation organisations from adopting relevant international standards as harmonised standards and that situation cannot be adequately mitigated by alternative measures, and where the condition set out in point (a) of paragraph 1 is met, the Commission may, as a measure of last resort, adopt implementing acts establishing common specifications without prior request to one or more European standardisation organisations to draft or revise harmonised standards. The draft implementing act shall be accompanied by a report justifying the exceptional situation and describing its implications for the internal market, the alternative measures which were taken and did not adequately mitigate the situation, and the reasons justifying the need to adopt common specifications. This report shall be presented to the Committee referred in paragraph 3. Within six months after the adoption of an implementing act pursuant to the first subparagraph, the Commission shall request, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft or to revise harmonised standards for those requirements covered by the implementing act. The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 44(3). Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply. The implementing acts adopted pursuant to this paragraph shall be repealed or amended by the Commission in accordance with paragraph 5. This paragraph shall cease to apply... [48 months after the date of entry into force of this Regulation]

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 common specifications or parts thereof, set out in Annex II.;

3. Before preparing the draft of the implementing act referred to in paragraphs 1 and 1a of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in, respectively, paragraphs 1 and 1a of this Article are fulfilled. In cases referred to in paragraph 1a, the Commission shall present the justification report to the Committee and shall obtain the Committee’s opinion in writing.

4. When preparing the draft of the implementing acts referred to in paragraphs 1 and 1a, the Commission shall take into account the views of the assigned expert group as well as of any other relevant bodies, and shall duly consult all relevant stakeholders.

5. Where a harmonised standard is adopted by a European standardisation organisation and proposed to the Commission for the purpose of publishing its reference in the Official Journal of the European Union, the Commission shall assess that standard in accordance with Regulation (EU) No 1025/2012. When the reference of a harmonised standard is published in the Official Journal of the European Union, the Commission shall repeal or amend the implementing acts referred to in paragraphs 1 and 1a, or parts thereof which cover the same requirements as those covered by that harmonised standard.

6. When a Member State or the European Parliament considers that a common specification or parts thereof does not entirely satisfy the essential requirements set out in Annex II which it covers, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend the implementing act establishing the common specification in question.’

(7) in Article 18, paragraph 3 is replaced by the following:

‘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 the subsystem or ▌ safety components 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 or, as appropriate, the EU declaration of conformity required in Article 19, and the instructions and safety information referred to in Article 11(7), where provided in electronic form, 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 and 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 directly accessed; ▌

(12) Annexes III to IX are amended in accordance with Annex I to this Regulation.

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 freely accessible online communication channel such as email addresses through which economic operators can be contacted without the need to register or to download or use additional applications specific to the economic operator;’

(b) the following point (10a) is inserted:

‘(10a) ‘common specification’ means a ▌ technical specification, other than a standard, that provides a means of complying with the essential requirements set out in Annex II applicable to the PPE; ▌

(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 contacted. ▌

(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 ▌ visible on the packaging, the instructions and information set out in point 1.4 of Annex II, which are related to the safe use of the PPE. Such information shall be easily visible and legible for consumers.

When drafting the instructions and information set out in point 1.4 of Annex II, which are related to the safe use of the PPE, the manufacturers shall take account of the intended use and foreseeable misuse by the end-user.

When the instructions and information, 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 directly 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 information 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 and information 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 24 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. The information shall clearly inform the end-user of their right to request the instructions for use in paper format.

8. The manufacturer shall provide the internet address or machine-readable code through which the EU declaration of conformity can be directly 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 contacted 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:

‘Article 14a

Common Specifications

1. The Commission may adopt implementing acts establishing common specifications covering requirements that provide a means to comply with the essential requirements set out in Annex II. Those implementing acts shall only be adopted where the following conditions are fulfilled:

(a) there is no harmonised standard covering those requirements the reference of which is published in the Official Journal of the European Union and no such reference is expected to be published within a reasonable period;

(b) the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft or to revise European standards for those requirements, and:

(i) the request has not been accepted by any of the European standardisation organisations to which the request was addressed; or

(ii) the request has been accepted by at least one of the European standardisation organisations to which the request was addressed, but the European standards requested:

(a) are not delivered within the deadline set in the request;

(b) do not comply with the request; or

(c) do not satisfy the requirements they aim to cover.

▌

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(3).

1a. In exceptional cases where the lack of cooperation by international standardisation organisations prevents European standardisation organisations from adopting relevant international standards as harmonised standards and that situation cannot be adequately mitigated by alternative measures, and where the condition set out in point (a) of paragraph 1 is met, the Commission may, as a measure of last resort, adopt implementing acts establishing common specifications without prior request to one or more European standardisation organisations to draft or revise harmonised standards. The draft implementing act shall be accompanied by a report justifying the exceptional situation and describing its implications for the internal market, the alternative measures which were taken and did not adequately mitigate the situation, and the reasons justifying the need to adopt common specifications. This report shall be presented to the Committee referred in paragraph 3. Within six months after the adoption of an implementing act pursuant to the first subparagraph, the Commission shall request, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft or to revise harmonised standards for those requirements covered by the implementing act. The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 44(3). Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply. The implementing acts adopted pursuant to this paragraph shall be repealed or amended by the Commission in accordance with paragraph 5. This paragraph shall cease to apply 48 months after the date of entry into force of this Regulation.

2. PPE that is in conformity with common specifications or parts thereof shall be presumed to be in conformity with the essential requirements set out in Annex II, covered by those common specifications or parts thereof ▌ .;

3. Before preparing the draft of the implementing act referred to in paragraphs 1 and 1a of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in, respectively, paragraphs 1 and 1a of this Article are fulfilled. In cases referred to in paragraph 1a, the Commission shall present the justification report to the Committee and shall obtain the Committee’s opinion in writing.

4. When preparing the draft of the implementing acts referred to in paragraphs 1 and 1a, the Commission shall take into account the views of the assigned expert group as well as of any other relevant bodies, and shall duly consult all relevant stakeholders.

5. Where a harmonised standard is adopted by a European standardisation organisation and proposed to the Commission for the purpose of publishing its reference in the Official Journal of the European Union, the Commission shall assess that standard in accordance with Regulation (EU) No 1025/2012. When the reference of a harmonised standard is published in the Official Journal of the European Union, the Commission shall repeal or amend the implementing acts referred to in paragraphs 1 and 1a, or parts thereof which cover the same requirements as those covered by that harmonised standard.

6. When a Member State or the European Parliament considers that a common specification or parts thereof does not entirely satisfy the essential requirements set out in Annex II which it covers, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend the implementing act establishing the common specification in question.’

(7) in Article 15, the following paragraph 5 is added:

‘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 the instructions and information in a digital product passport, the information required in Annex IX to be included in the EU declaration of conformity or, as appropriate, the EU declaration of conformity required in Article 15, and the instructions and information referred to in Article 8(7), where provided in electronic form, 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 and common specifications, and of the relevant provisions of Union harmonisation legislation and of national legislation;’

▌

(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 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 freely accessible online communication channel such as email addresses through which economic operators can be contacted without the need to register, download or use additional applications specific to the economic operator;’

(b) the following point (23a) is inserted:

‘(23a) ‘common specification’ means a ▌ technical specification, other than a standard, that provides a means of complying with the essential requirements set out in Annex I applicable to an appliance or a fitting.’

(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 contacted. 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 contacted. 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 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 appliance when deciding the specific format for the instructions and safety information.

In the case of an appliance ▌ 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 appliance, the safety information. Such safety information shall be easily visible and legible for consumers.

When drafting the instructions and 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 directly accessed as well as by 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 directly accessed.

When the instructions or safety information, referred to in the first subparagraph, are provided in electronic form, the manufacturer shall:

(a) mark on the appliance ▌ , or, where that is not possible, on its packaging or in an accompanying document, how to directly 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 safety information 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 ▌ ;

(c) make them accessible online during the expected lifetime of the appliance ▌ and for at least 10 years after the placing on the market of the appliance ▌ .

However, the end-user may, at time of the purchase of the appliance or fitting, or up to 24 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. The safety information shall clearly inform the end-user of their right to request the instructions in paper format.;’

(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:

(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 directly 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 directly 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 directly 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.;’

(7) the following Article 13a is inserted:

‘Article 13a

Common Specifications

1. The Commission may adopt implementing acts establishing common specifications that provide a means to comply with the essential requirements set out in Annex I. Those implementing acts shall only be adopted where the following conditions are fulfilled:

(a) there is no harmonised standard covering those requirements the reference of which is published in the Official Journal of the European Union and no such reference is expected to be published within a reasonable period;

(b) the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft or to revise European standards for those requirements, and:

(i) the request has not been accepted by any of the European standardisation organisations to which the request was addressed; or

(ii) the request has been accepted by at least one of the European standardisation organisations to which the request was addressed, but the European standards requested:

(a) are not delivered within the deadline set in the request;

(b) do not comply with the request; or

(c) do not satisfy the requirements they aim to cover.

▌

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 42(3).

1a. In exceptional cases where the lack of cooperation by international standardisation organisations prevents European standardisation organisations from adopting relevant international standards as harmonised standards and that situation cannot be adequately mitigated by alternative measures, and where the condition set out in point (a) of paragraph 1 is met, the Commission may, as a measure of last resort, adopt implementing acts establishing common specifications without prior request to one or more European standardisation organisations to draft or revise harmonised standards. The draft implementing act shall be accompanied by a report justifying the exceptional situation and describing its implications for the internal market, the alternative measures which were taken and did not adequately mitigate the situation, and the reasons justifying the need to adopt common specifications. This report shall be presented to the Committee referred in paragraph 3. Within six months after the adoption of an implementing act pursuant to the first subparagraph, the Commission shall request, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft or to revise harmonised standards for those requirements covered by the implementing act. The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 42(3). Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply. The implementing acts adopted pursuant to this paragraph shall be repealed or amended by the Commission in accordance with paragraph 5. This paragraph shall cease to apply 48 months after the date of entry into force of this Regulation.

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 common specifications or parts thereof, set out in Annex I.;

3. Before preparing the draft of the implementing act referred to in paragraphs 1 and 1a of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in, respectively, paragraphs 1 and 1a of this Article are fulfilled. In cases referred to in paragraph 1a, the Commission shall present the justification report to the Committee and shall obtain the Committee’s opinion in writing.

4. When preparing the draft of the implementing acts referred to in paragraphs 1 and 1a, the Commission shall take into account the views of the assigned expert group as well as of any other relevant bodies, and shall duly consult all relevant stakeholders.

5. Where a harmonised standard is adopted by a European standardisation organisation and proposed to the Commission for the purpose of publishing its reference in the Official Journal of the European Union, the Commission shall assess that standard in accordance with Regulation (EU) No 1025/2012. When the reference of a harmonised standard is published in the Official Journal of the European Union, the Commission shall repeal or amend the implementing acts referred to in paragraphs 1 and 1a, or parts thereof which cover the same requirements as those covered by that harmonised standard.

6. When a Member State or the European Parliament considers that a common specification or parts thereof does not entirely satisfy the essential requirements set out in Annex II which it covers, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend the implementing act establishing the common specification in question.’

(8) Article 14 is amended as follows:

(a) paragraph 4 is replaced by the following:

‘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 directly 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 V to be included in the EU declaration of conformity, or as appropriate, the EU declaration of conformity required in Article 15, and the instructions and safety information referred to in Article 7(7), where provided in electronic form, shall be provided only in that digital product passport.;’

(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 and 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 directly 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 freely accessible online communication channel such as email addresses through which economic operators can be contacted without the need to register or to download or use additional applications specific to the economic operator;’

(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 directly 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 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 directly 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 directly 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.;’

(8a) in Article 20, paragraph 8 is replaced by the following:

8. When a Member State or the European Parliament considers that a common specification or parts thereof does not entirely satisfy the essential requirements set out in Annex III which it covers, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend the implementing act establishing the common specification in question.

(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 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 or, as appropriate, the EU declaration of conformity required in Article 21, and the instructions and information referred to in Article 10(7), where provided in digital format, 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 partly completed machinery ▌ 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 assembly instructions in a digital product passport, the information required in Parts B of Annex V to be included in the EU declaration of incorporation or, as appropriate, the EU declaration of incorporation required in Article 22, and the assembly instructions referred to in Article 11(7), where provided in electronic form, 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 freely accessible online communication channel such as email addresses through which economic operators can be contacted without the need to register or to download or use additional applications specific to the economic operator;’

(1a) in Article 16, the following paragraph is added:

3a. When a Member State or the European Parliament consider that a common specification does not entirely satisfy the requirements laid down in Articles 9, 10, 12, 13, 14 and 78, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and, if appropriate, may amend the implementing act establishing the common specification in question.

(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) in Article 18(2), the third sentence is replaced by the following:

‘It shall be drawn up in electronic form.;’

(4) Article 38 is amended as follows:

(a) paragraph 1 is replaced by the following:

‘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:

(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 or safety information 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 24 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.; The safety information shall clearly inform the end-user of their right to request the instructions in paper format.’

(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) in paragraph 10, the second sentence is replaced by the following:

‘That information and documentation shall be provided in electronic form.;’

(5) in Article 39, the second sentence is replaced by the following:

‘That information and documentation shall be provided, in electronic form, free of charge.;’

(6) in Article 40(3), point (b) is replaced by the following:

‘(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) in paragraph 8, the second sentence is replaced by the following:

‘That information and the documentation shall be provided in electronic form.;’

(8) in Article 42(6), the second sentence is replaced by the following:

‘That information and the documentation shall be provided in electronic form.;’

(9) Annexes VIII, IX and XIII are amended in accordance with Annex V to this Regulation.

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 freely accessible online communication channel such as email addresses through which economic operators can be contacted without the need to register or to download or use additional applications specific to the economic operator;’

(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.;’

(6a) in Article 36(2), the second sentence of the second subparagraph is replaced by the following:

‘That information shall be provided in electronic form within 15 days of receipt of a request by the market surveillance authority.’

(6b) in Article 79(1), point (a)(i) is replaced by the following:

‘(i) until 31 December 2028, as regards photovoltaic panels, space and combination heaters, water heaters, solid fuel local space heaters, air conditioners including air-to-air heat pumps and comfort fans, solid fuel boilers, air heating and cooling products, ventilation units, vacuum cleaners, cooking appliances, water pumps, industrial fans, circulators, external power supplies, computers, servers and data storage products, power transformers, professional refrigeration equipment and imaging equipment; ’

(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), 2023/1230, (EU) 2023/1542 and (EU) 2024/1781 before ... [30 months after the date of entry into force of this amending Regulation ▌ ].

Article 9 Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 7, point (6b), shall apply from … [date of entry into force of this amending Regulation].

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The following provisions shall apply from ... [30 months after the date of entry into force of this amending Regulation]:

(a) Article 2, point(1)(a), point (2)(a), (c), (d) and (e), and points (3), (4), (5), (7), (8) and (11);

(b) Article 3, point (1)(a), point (2)(a), (c), (d) and(e), and points (3), (4), (5), (7) and (8);

(c) Article 4, point (1)(a), points (2)(a), (c) and (d), and points (3), (4), (5), (6), (8), (9) and (12);

(ca) Article 5;

(d) Article 6;

(da) Article 7, points (1), (2), (3), (4), (5), (6), (6a), and (7);

(e) 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);

(f) Annex II, point (1)(a), point (3)(a), (c)(i) and (d)(i), point (4)(a), point (5)(a) and point (6)(a);

(g) Annex III, point (1)(a)(i), (c), (e) and(g) and point (2)(a);

(ga) Annex IV;

(h) Annex V.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the European Parliament For the Council

The President The President

ANNEX I

Annexes III to IX to Regulation (EU) 2016/424 are amended as follows:

(1) Annex III is amended as follows:

(a) in point 3, point (a) is replaced by the following:

‘(a) the name, postal address and digital contact of the manufacturer and, if the application is lodged by the authorised representative, his name, postal address and digital contact as well;’

(b) in point 4, points 4.2 and 4.3a are replaced by the following:

‘4.2. verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the elements that have been designed in accordance with the applicable provisions of the relevant harmonised standards or common specifications, as well as the elements which have been designed in accordance with other relevant technical specifications;

4.3. carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards or common specifications, these have been applied correctly;

4.3a. carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards or common specifications have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential requirements of this Regulation;’

(c) in point 6, first subparagraph, the second sentence is replaced by the following:

‘The certificate shall contain the name, postal address and digital contact of the manufacturer, the conclusions of the examination, any conditions for its validity, the necessary data for identification of the approved type (subsystem or safety component) and if relevant, descriptions of its functioning.;’

(2) Annex IV is amended as follows:

(a) in point 3.1., point (a) is replaced by the following:

‘(a) the name, postal address and digital contact of the manufacturer and, if the application is lodged by the authorised representative, his name, postal address and digital contact as well;’

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(3) Annex V is amended as follows:

(a) in point 3.1., point (a) is replaced by the following:

‘(a) the name, postal address and digital contact of the manufacturer and, if the application is lodged by the authorised representative, his name, postal address and digital contact as well;’

(b) point 4.1 is replaced by the following:

‘4.1. All subsystems or safety components shall be individually examined and appropriate tests set out in the relevant harmonised standard(s), and/or common specification(s), and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify conformity with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Regulation.

In the absence of such a harmonised standard or common specification, the notified body concerned shall decide on the appropriate tests to be carried out.;’

(c) point 5.2. is replaced by the following:

‘5.2. A random sample shall be taken from each lot. All the subsystems or safety components in the sample shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or common specification(s), and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the approved type described in the EU-type examination certificate and with the applicable requirements of this Regulation and to determine whether the lot is accepted or rejected. In the absence of such a harmonised standard or common specification, the notified body concerned shall decide on the appropriate tests to be carried out.;’

(4) Annex VI is amended as follows:

(a) in point 3.1., point (a) is replaced by the following:

‘(a) the name, postal address and digital contact of the manufacturer and, if the application is lodged by the authorised representative, his name, postal address and digital contact as well;’

(b) in point 3.2., paragraph 1 is replaced by the following:

‘The notified body shall examine the technical documentation for the subsystem or the safety component and shall carry out the appropriate examinations and tests set out in the relevant harmonised standards, and/or common specifications, and/or equivalent tests set out in other relevant technical specifications, to check the conformity of the subsystem or the safety component with the applicable requirements of this Regulation, or have them carried out. In the absence of such a harmonised standard or common specification the notified body concerned shall decide on the appropriate tests to be carried out.;’

(5) Annex VII is amended as follows:

(a) in point 3.1., point (a) is replaced by the following:

‘(a) the name, postal address and digital contact of the manufacturer and, if the application is lodged by the authorised representative, his name, postal address and digital contact as well;’

(b) in point 3.2., point (b) is replaced by the following:

‘(b) the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards or common specifications will not be applied in full, the means, including other relevant technical specifications, that will be used to ensure that the essential requirements of this Regulation will be met;’

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(d) in point 3.6.2., point (a) is replaced by the following:

‘(a) the name, postal address and digital contact of the manufacturer;’

(e) in point 3.6.3, first subparagraph, the second sentence is replaced by the following:

‘That certificate shall give the name, postal address and digital contact of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for identification of the approved design.;’

(6) in Annex VIII, point 2, point (c) is replaced by the following:

‘(c) a list of the harmonised standards referred to in Article 17, applied in full or in part, the references of which have been published in the Official Journal of the European Union, and a list of common specifications, applied in full or in part, and where those harmonised standards or common specifications, have not been applied descriptions of the solutions adopted to meet the essential requirements of this Regulation including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards or common specifications, the technical documentation shall specify the parts which have been applied;’

(7) Annex IX is amended as follows:

(a) point 2 is replaced by the following:

‘2. Name, postal address and digital contact of the manufacturer and, where applicable, his authorised representative;’

(b) point 6 is replaced by the following:

‘6. References to the relevant harmonised standards or common specifications used or references to the other technical specifications in relation to which conformity is declared:.’

ANNEX II

Annexes II, III, V, VII, VIII, and IX to Regulation (EU) 2016/425 are amended as follows:

(1) in Annex II, point 1.4 is amended as follows:

(a) in the first subparagraph, the first sentence is replaced by the following:

‘In addition to the name, postal address and digital contact of the manufacturer, the instructions that must be supplied with the PPE must contain all relevant information on:;’

(b) points (k) and (l) are replaced by the following:

‘(k) references to the relevant harmonised standard(s) or common specification (s) used, including the date of the standard(s) or specification(s), or references to the other technical specifications used;

(l) the internet address or machine-readable code through which the EU declaration of conformity can be directly accessed. ▌

(2) in Annex III, points (f) and (g) are replaced by the following:

‘(f) the references of the harmonised standards referred to in Article 14 and the common specifications referred to in Article 14a that have been applied for the design and manufacture of the PPE. In the event of partial application of harmonised standards or common specifications, the documentation shall specify the parts which have been applied;

(g) where harmonised standards or common specifications have not been applied or have been only partially applied, descriptions of the other technical specifications that have been applied in order to satisfy the applicable essential health and safety requirements;’

(3) Annex V is amended as follows:

(a) in point 3., point (a) is replaced by the following:

‘(a) the name, postal address and digital contact of the manufacturer and, if the application is lodged by the authorised representative, his name, postal address and digital contact as well;’

(b) in point 4, points (d) to (f) are replaced by the following:

‘(d) verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards or common specifications as well as the elements which have been designed in accordance with other technical specifications;

(e) carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards or common specifications, these have been applied correctly;

(f) carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards or common specifications have not been applied, the solutions adopted by the manufacturer, including those in other technical specifications applied, meet the corresponding essential health and safety requirements and have been applied correctly.;’

(c) point 6.2., is amended as follows:

(i) point (b) is replaced by the following:

‘(b) the name, postal address and digital contact of the manufacturer and, if the application is lodged by the authorised representative, the latter's name, postal address and digital contact;’

(ii) point (e) is replaced by the following:

‘(e) where harmonised standards or common specifications have been fully or partially applied, the references of those standards or specifications or parts thereof;’

(d) point 7.6. is amended as follows:

(i) point (a) is replaced by the following:

‘(a) his name, postal address and digital contact and data identifying the EU type-examination certificate concerned;’

(ii) point (b) is replaced by the following:

‘(b) confirmation that there has been no modification to the approved type as referred to in point 7.2, including materials, sub-components or sub-assemblies, nor to the relevant harmonised standards or common specifications or other technical specifications applied;’

(4) Annex VII is amended as follows:

(a) in point 3., point (a) is replaced by the following:

‘(a) the name, postal address and digital contact of the manufacturer and, if the application is lodged by the authorised representative, his name, postal address and digital contact;’

(b) point 4.3. is replaced by the following:

‘4.3. An adequate statistical sample of the manufactured PPE shall be selected by the notified body at a place agreed between the body and the manufacturer. All items of PPE of the sample shall be examined, and appropriate tests set out in the relevant harmonised standard(s), and/or common specification(s), and/or equivalent tests set out in other relevant technical specifications shall be carried out in order to verify the conformity of the PPE with the type described in the EU type-examination certificate and with the applicable essential health and safety requirements.;’

(5) Annex VIII is amended as follows:

(a) in point 3.1., point (a) is replaced by the following:

‘(a) the name, postal address and digital contact of the manufacturer and, if the application is lodged by the authorised representative, his name, postal address and digital contact as well;’

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(6) Annex IX is amended as follows:

(a) point 2 is replaced by the following:

‘2. Name, postal address and digital contact of the manufacturer and, where applicable, his authorised representative:;’

(b) point 6 is replaced by the following:

‘6. References to the relevant harmonised standards or common specifications used, including the date of the standard or common specification, or references to the other technical specifications, including the date of the specification, in relation to which conformity is declared:.’

ANNEX III

Annexes III and V to Regulation (EU) 2016/426 are amended as follows:

(1) Annex III is amended as follows:

(a) point 1.3.1. is amended as follows:

(i) point (a) is replaced by the following:

‘(a) the name, postal address and digital contact of the manufacturer and, if the application is lodged by the authorised representative, his name, postal address and digital contact as well;’

(ii) in point (c), point (4) is replaced by the following:

‘(4) a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and a list of common specifications, applied in full or in part, and, where those harmonised standards or common specifications have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Regulation, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards or common specifications, the technical documentation shall specify the parts which have been applied;’

(iii) in point (e), the second sentence is replaced by the following:

‘(e) This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards or common specifications have not been applied in full.;’

(b) in point 1.4., points 1.4.3. and 1.4.4. are replaced by the following:

‘1.4.3. carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards or common specifications, these have been applied correctly;

1.4.4. carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards or common specifications have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential requirements of this Regulation;’

(c) in point 1.6., first subparagraph, the second sentence is replaced by the following:

‘The certificate shall contain the name, postal address and digital contact of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity, the necessary data for identification of the approved type, such as the type of gas, appliance category and gas supply pressure, and, if relevant, descriptions of its functioning.;’

(d) In point 2.3, first subparagraph, the second sentence is replaced by the following:

‘An adequate sample of the final appliances or fittings taken on site by the notified body before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the harmonised standards, and/or common specifications, and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to check the conformity of the appliance or the fitting with the relevant requirements of this Regulation.;’

(e) in point 3.3.1., point (a) is replaced by the following:

‘(a) the name, postal address and digital contact of the manufacturer and, if the application is lodged by the authorised representative, his name, postal address and digital contact as well;’

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(g) in point 4.3.1., point (a) is replaced by the following:

‘(a) the name, postal address and digital contact of the manufacturer and, if the application is lodged by the authorised representative, his name, postal address and digital contact as well;’

(i) point 5.4.1. is replaced by the following:

‘5.4.1. All appliances or fittings shall be individually examined and appropriate tests set out in the relevant harmonised standard(s), and/or common specifications, and/or equivalent tests set out in other relevant technical specifications shall be carried out in order to verify conformity with the approved type described in the EU type-examination certificate and with the appropriate requirements of this Regulation.

In the absence of such a harmonised standard or common specification, the notified body concerned shall decide on the appropriate tests to be carried out.;’

(j) point 5.5.2. is replaced by the following:

‘5.5.2. A random sample shall be taken from each lot in accordance with the requirements of point 5.5.3. All appliances or fittings in a sample shall be individually examined and appropriate tests set out in the relevant harmonised standard(s), and/or common specification(s), and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the applicable requirements of this Regulation and to determine whether the lot is accepted or rejected. In the absence of such a harmonised standard or common specification, the notified body concerned shall decide on the appropriate tests to be carried out.;’

(k) in point 6.2.1., point (d) is replaced by the following:

‘(d) a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union, and a list of common specifications, applied in full or in part, and, where those harmonised standards or common specifications have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Regulation, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards or common specifications, the technical documentation shall specify the parts which have been applied.;’

(l) in point 6.4., the first subparagraph is replaced by the following:

‘A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant harmonised standards or common specifications and/or equivalent tests set out in other relevant technical specifications, to check the conformity of the appliances or fittings with the applicable requirements of this Regulation, or have them carried out. In the absence of such a harmonised standard or common specification the notified body concerned shall decide on the appropriate tests to be carried out.;’

(2) Annex V is amended as follows:

(a) point 2 is replaced by the following:

‘2. Name, postal address and digital contact of the manufacturer and, where applicable, his authorised representative:;’

(b) paragraph 6 is replaced by the following:

‘6. References to the relevant harmonised standards or common specifications used or references to the other technical specifications in relation to which conformity is declared.’

ANNEX IV

Annexes III, V, VII, IX, and X to Regulation (EU) 2023/1230 are amended as follows:

(1) Annex III is amended as follows:

(a) in point 1.7.4.2., point 1 is amended as follows:

(i) point (a) is replaced by the following:

‘(a) the business name, full postal address and digital contact of the manufacturer and, where applicable, of its authorised representative;’

(ii) point (c) is replaced by the following:

‘(c) the EU declaration of conformity, or the internet address or machine-readable code, through which the EU declaration of conformity can be directly accessed, in accordance with Article 10(8);’

(b) point 4.3.1. is amended as follows:

(i) the first subparagraph is replaced by the following:

‘Each length of lifting chain, rope or webbing not forming part of an assembly shall bear a mark or, where this is not possible, a plate or irremovable ring bearing the name, postal address and digital contact of the manufacturer and the identifying reference of the relevant certificate.;’

(ii) point (a) is replaced by the following:

‘(a) the name, postal address and digital contact of the manufacturer;’

(2) Annex V is amended as follows:

(a) in Part A, point 2 is replaced by the following:

‘2. Name, postal address and digital contact of the manufacturer and, where applicable, its authorised representative.;’

(b) in Part B, point 2 is replaced by the following:

‘2. Name, postal address and digital contact of the manufacturer and, where applicable, its authorised representative.;’

(3) Annex VII is amended as follows:

(a) in point 3., point (a) is replaced by the following:

‘(a) the name, postal address and digital contact of the manufacturer and, if the application is lodged by an authorised representative, the name, postal address and digital contact of that authorised representative;’

(b) in point 6.2., point (b) is replaced by the following:

‘(b) the name, postal address and digital contact of the manufacturer and, if the application is lodged by an authorised representative, the name, postal address and digital contact of that authorised representative;’

(c) in point 7.6., point (a) is replaced by the following:

‘(a) its name, postal address and digital contact and data identifying the EU type-examination certificate concerned;’

(4) in Annex IX, point 3.1., point (a) is replaced by the following:

‘(a) the name, postal address and digital contact of the manufacturer and, if the application is lodged by an authorised representative, the name, postal address and digital contact of that authorised representative;’

(5) Annex X is amended as follows:

(a) in point 2., point (a) is replaced by the following:

‘(a) the name, postal address and digital contact of the manufacturer and, if the application is lodged by an authorised representative, the name, postal address and digital contact of that authorised representative.’

ANNEX V

Annexes VIII, IX and XIII to Regulation (EU) 2023/1542 are amended as follows:

(1) in Annex VIII, Module D1: Quality assurance of the production process, point 5.1, point (a) is replaced by the following:

‘(a) the name, postal address and digital contact of the manufacturer and, if the application is lodged by the manufacturer’s authorised representative, its name, postal address and digital contact as well,;’

(2) in Annex IX, point 2 is replaced by the following:

‘Name, postal address and digital contact of the manufacturer and, where applicable, its authorised representative:;’

(3) in Annex XIII, point 1, the following point (t) is added:

‘(t) ‘clear, understandable and readable instructions for use in a format that makes it possible to print, download and save them on an electronic device so that the user can access them at all times, in particular during a breakdown of the battery (only for stationary battery energy storage systems).’