Text · Amendment list
Amending Regulations (EU) No 765/2008, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2023/1230, (EU) 2023/1542 and (EU) 2024/1781 as regards digitalisation and common specifications
Document IMCO-AM-779374 · COM(2025)0504 – 2025/0134(COD)
- Kind
- Amendment list IMCO-AM-779374
- Date
- 24 October 2025
- Committee
- Committee on the Internal Market and Consumer Protection
- Dossier
- 2025-0134
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- COM(2025)0504 – 2025/0134(COD)
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| Text proposed by the Commission | Amendment |
|---|---|
| (1) Reporting requirements play a key role in ensuring proper monitoring and correct enforcement of legislation. However, in order to ensure that they fulfil their intended purpose and to limit the administrative burden, it is important to streamline those requirements. | (1) Reporting requirements play a key role in ensuring proper monitoring and correct enforcement of legislation. The costs of reporting are overall largely offset by the benefits they bring, in particular as regards monitoring and ensuring compliance with key policy measures. However, in order to ensure that they fulfil their intended purpose and to limit the administrative burden, it is important to streamline those requirements. |
| Text proposed by the Commission | Amendment |
|---|---|
| (4) The increasing importance of digitalisation in simplifying regulatory frameworks necessitates the reduction and modernisation of reporting requirements and economic operators’ obligations. In line with the efforts to accelerate digitalisation, it is essential to fully digitalise business-to-authority reporting and economic operators’ obligations when they do not affect protection and safety of consumers. Embracing digitalisation will not only simplify compliance procedures but also enhance the overall efficiency of the regulatory framework, ultimately benefiting both businesses and authorities alike. | (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. 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. |
| Text proposed by the Commission | Amendment |
|---|---|
| (4a) To accompany the digital transition and prevent disproportionate burdens for micro-enterprises and small- and medium-sized enterprises (SMEs), the Commission and Member States are required to set up dedicated ‘technical help desks’ for the implementation of digital procedures, linked to the European Digital Innovation Hubs of the Digital Europe Programme, and provide free or co-financed assistance, including training and access to standardised tools. |
| Text proposed by the Commission | Amendment |
|---|---|
| (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 electronically accompany the product. The manufacturer will make sure that the EU declaration of conformity is accessible through an internet address or a machine-readable code. | (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 electronically accompany the product. The manufacturer will make sure that the EU declaration of conformity is directly accessible through an internet address or a machine-readable code, meaning that the authorities would not have to navigate through intermediate steps, such as search menus, external websites, or additional login procedures to reach the specific EU declaration of conformity. Direct access via the internet address or the machine-readable code should be free of charge, without the need to provide any personal data, to download or use additional applications specific to the economic operator, or an obligation to register solely in order to access the EU declaration of conformity. |
| Text proposed by the Commission | Amendment |
|---|---|
| (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 electronically accompany the product. The manufacturer will make sure that the EU declaration of conformity is accessible through an internet address or a machine-readable code. | (7) Moreover, Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, and (EU) 2023/1230 require that a copy of the EU declaration of conformity accompanies the product. Considering the evolution of digitalisation, it is essential to modernise this obligation by requiring that such EU declaration of conformity accompany the product in electronic form. The manufacturer should therefore make sure that the EU declaration of conformity is directly accessible through an internet address or a machine-readable code, free of charge, without the need for 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. |
| Text proposed by the Commission | Amendment |
|---|---|
| (8) Taking into account that in 2024 no less than 94% of EU households had access to internet10 , the paper format of the instructions accompanying the products under the scope of the Regulations concerned is outdated and not aligned with the current technologies, the practice of consumers nor with green objectives. Consequently, the possibility for a digital format of the instructions should be introduced in the Regulations concerned. This will allow manufacturers to provide instructions in digital format, if they wish to do so. Where manufacturers choose to provide instructions in digital format, in order to still protect the safety of consumers, the safety information, including instructions having impact on product safety, should be provided in paper format or marked on the product. Moreover, end-users should be able to obtain a paper copy of the instructions for use or safety information, upon request – at the time of the purchase and for a certain period of time after their purchase. | (8) Taking into account that in 2024 no less than 94% of EU households had access to internet10 , the paper format of the instructions accompanying the products under the scope of the Regulations concerned is outdated and not aligned with the current technologies, the practice of consumers nor with green objectives. Consequently, the possibility for a digital format of the instructions should be introduced in the 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. Safety information, including instructions having an impact on the safe use of the products, might be provided in digital format 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. However, where it is reasonably foreseeable that a product, even if primarily intended for professional use, could also be used by consumers, manufacturers should provide the safety information in paper format or markedmark it directly on the product. 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. Such information should therefore be easily visible and legible, thereby guaranteeing a high level of consumer protection and safeguarding public safety. Instructions and safety information provided in digital format should be directly accessible in particular by taking 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 as to ensure usability by all end-users, including persons with disabilities. Instructions and safety information should be directly accessible through an internet address or a machine-readable code, free of charge, without the need for 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. 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 purchase and for a certain period of time after their purchase. |
| 10 Source: Digital economy and society statistics - households and individuals - Statistics Explained. | 10 Source: Digital economy and society statistics - households and individuals - Statistics Explained. |
| Text proposed by the Commission | Amendment |
|---|---|
| (8) Taking into account that in 2024 no less than 94% of EU households had access to internet10 , the paper format of the instructions accompanying the products under the scope of the Regulations concerned is outdated and not aligned with the current technologies, the practice of consumers nor with green objectives. Consequently, the possibility for a digital format of the instructions should be introduced in the Regulations concerned. This will allow manufacturers to provide instructions in digital format, if they wish to do so. Where manufacturers choose to provide instructions in digital format, in order to still protect the safety of consumers, the safety information, including instructions having impact on product safety, should be provided in paper format or marked on the product. Moreover, end-users should be able to obtain a paper copy of the instructions for use or safety information, upon request – at the time of the purchase and for a certain period of time after their purchase. | (8) Taking into account that in 2024 no less than 94% of EU households had access to internet10, 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, in order to still protect the safety of consumers, instructions having impact on product safety, should be provided in paper format or marked on the product. However, safety information for consumers should always be provided in paper format or marked on the product. Safety information and instructions having an impact on product safety are to be intended as essential details necessary for safe and efficient use under reasonably foreseeable conditions, even if not intended for consumers. In addition, where it is reasonably foreseeable that a product, even if primarily intended for professional use by end-users, could also be used by consumers, manufacturers should provide the safety information in paper format or mark it directly on the product. Moreover, end-users should be able to obtain a paper copy of the instructions for use or safety information, upon request – at the time of the purchase and for a certain period of time after their purchase. |
| 10 Source: Digital economy and society statistics - households and individuals - Statistics Explained. | 10 Source: Digital economy and society statistics - households and individuals - Statistics Explained. |
| Text proposed by the Commission | Amendment |
|---|---|
| (8) Taking into account that in 2024 no less than 94% of EU households had access to internet10, the paper format of the instructions accompanying the products under the scope of the Regulations concerned is outdated and not aligned with the current technologies, the practice of consumers nor with green objectives. Consequently, the possibility for a digital format of the instructions should be introduced in the Regulations concerned. This will allow manufacturers to provide instructions in digital format, if they wish to do so. Where manufacturers choose to provide instructions in digital format, in order to still protect the safety of consumers, the safety information, including instructions having impact on product safety, should be provided in paper format or marked on the product. Moreover, end-users should be able to obtain a paper copy of the instructions for use or safety information, upon request – at the time of the purchase and for a certain period of time after their purchase. | (8) Considering that in 2024 no less than 94% of EU households had access to internet, the paper format of the instructions for use accompanying the products under the scope of the Directives concerned is outdated and is not aligned with the technologies available, the practice of consumers nor with green objectives. The possibility to provide the instructions for use in a digital format should therefore be introduced. Manufacturers will then be able to provide digital instructions where they deem it appropriate. Where manufacturers choose the digital format, in order to protect the safety of consumers, the safety information, including instructions having impact on product safety, must be provided in paper format at the request of the consumer. End-users must 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. Manufacturers must also offer alternative means of sending the instructions on paper directly to the end-user free of charge, without creating a burden for the distributor. Distributors are not required to print or store the instructions, but may do so voluntarily. The Commission should also assess whether digital security information could be equivalent or even more effective; this assessment shall feed into a report to be published within three years. The Commission shall revise the legislation as amended by this omnibus act accordingly. |
| 10 Source: Digital economy and society statistics - households and individuals - Statistics Explained. |
| Text proposed by the Commission | Amendment |
|---|---|
| (8) Taking into account that in 2024 no less than 94% of EU households had access to internet10 , the paper format of the instructions accompanying the products under the scope of the Regulations concerned is outdated and not aligned with the current technologies, the practice of consumers nor with green objectives. Consequently, the possibility for a digital format of the instructions should be introduced in the Regulations concerned. This will allow manufacturers to provide instructions in digital format, if they wish to do so. Where manufacturers choose to provide instructions in digital format, in order to still protect the safety of consumers, the safety information, including instructions having impact on product safety, should be provided in paper format or marked on the product. Moreover, end-users should be able to obtain a paper copy of the instructions for use or safety information, upon request – at the time of the purchase and for a certain period of time after their purchase. | (8) Taking into account that in 2024 no less than 94% of EU households had access to internet10 , the paper format of the instructions accompanying the products under the scope of the Regulations concerned is outdated and not aligned with the current technologies, the practice of consumers nor with green objectives. Consequently, the possibility for a digital format of the instructions should be introduced in the Regulations concerned. This will allow manufacturers to provide instructions in digital format, if they wish to do so. Where manufacturers choose to provide instructions in digital format, in order to still protect the safety of consumers, the safety information, including instructions having impact on product safety, should be provided in paper format, upon request by the consumer, or marked on the product. Moreover, end-users should be able to obtain a paper copy of the instructions for use or safety information, upon request – at the time of the purchase and for a certain period of time after their purchase. |
| 10 Source: Digital economy and society statistics - households and individuals - Statistics Explained. | 10 Source: Digital economy and society statistics - households and individuals - Statistics Explained. |
| Text proposed by the Commission | Amendment |
|---|---|
| (8 a) In order to ensure that 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 and instructions, manufacturers should provide information and instructions in a form that is easily visible and legible. This would guarantee a high level of consumer protection and safeguards public safety. Instructions and safety information provided in digital format should take into account the accessibility requirements set out in Annex I of Directive (EU) 2019/882, so as to ensure usability by all consumers and end-users, including persons with disabilities. |
| Text proposed by the Commission | Amendment |
|---|---|
| (8a) In order to facilitate compliance with the electronic format reporting obligations without imposing complex IT infrastructures, simplified standardised templates ('SME templates') should be provided for the digital declaration of conformity and for electronic documentation management, available to all economic operators and designed in particular to meet the needs of SMEs. |
| Text proposed by the Commission | Amendment |
|---|---|
| (8 a) 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. |
| Text proposed by the Commission | Amendment |
|---|---|
| (8 b) 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 should provide 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 |
| Text proposed by the Commission | Amendment |
|---|---|
| (8 b) 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 should provide 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. |
| Text proposed by the Commission | Amendment |
|---|---|
| (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. | (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 a 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 providing any personal data, downloading or using 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 other direct means of digital communication without intermediate steps and allowing for traceability of exchanges. However, it should not be understood as encompassing automatic replies to queries, chatbots, fax numbers, or telephone lines. 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. |
| Text proposed by the Commission | Amendment |
|---|---|
| (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. | (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 to provide any personal data, to download or use additional applications specific to the economic operator, or to register solely for the purpose of contacting the economic operator. Such digital contact may include, for example, an email address or a contact form on a website. However, it should not be understood as encompassing automatic replies to queries, chatbots, fax numbers, or telephone lines. |
| Text proposed by the Commission | Amendment |
|---|---|
| (10a) Where products are manufactured on a small scale or in niche segments, it should be possible to carry out the required digitalisation through simplified procedures, such as by uploading information to national portals that are fully accessible to the authorities of other Member States and to the Commission and that comply with interoperability and market surveillance requirements. |
| Text proposed by the Commission | Amendment |
|---|---|
| (11) The current Union standardisation framework, which is based on Regulation (EU) No 1025/2012 of the European Parliament and of the Council11, 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. | (11) Harmonised standards remain the preferred option. Common specifications should be temporary and proportionate, and adopted only when European Norms (ENs) are not sufficient and/or in cases of urgency, after inclusive consultation with SMEs. |
| 11 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12, ELI: http://data.europa.eu/eli/reg/2012/1025/oj). |
| Text proposed by the Commission | Amendment |
|---|---|
| (11) The current Union standardisation framework, which is based on Regulation (EU) No 1025/2012 of the European Parliament and of the Council11 , 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. | (11) The current Union standardisation framework, which is based on Regulation (EU) No 1025/2012 of the European Parliament and of the Council11, 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 or there is an urgent need, 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 an alternative option to provide businesses with legal predictability and prove compliance with Union law, to cater for such situations. |
| 11 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12, ELI: http://data.europa.eu/eli/reg/2012/1025/oj). | 11 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12, ELI: http://data.europa.eu/eli/reg/2012/1025/oj). |
| Text proposed by the Commission | Amendment |
|---|---|
| (12) As the digital product passport is foreseen in certain EU legislation, such as Regulation (EU) 2023/1542, it is essential to require economic operators to store the information contained in the EU declaration of conformity and instructions in the digital product passport where a product is covered by multiple pieces of legislation. This approach would reduce the administrative burden on manufacturers, as they would no longer need to maintain separate storage locations for compliance documents. By storing the documentation in one place, all necessary documents demonstrating product compliance would be easily accessible, ensuring transparency and facilitating compliance. This streamlined approach would enhance the overall efficiency of the regulatory framework, and it aligns with the principle that where several pieces of Union harmonisation legislation apply to a product, the manufacturer or other economic operator, where appropriate, should provide a single EU declaration of conformity. | (12) As the digital product passport is foreseen in certain EU legislation, such as Regulation (EU) 2023/1542, it is essential to require economic operators to store the information contained in the EU declaration of conformity and instructions in the digital product passport where a product is covered by multiple pieces of legislation. 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. |
| Text proposed by the Commission | Amendment |
|---|---|
| (14a) Given the varying organisational and financial capacities, a differentiated application of the transposition measures should be provided for, granting micro-enterprises and SMEs an additional period to comply compared to large enterprises. |
| Text proposed by the Commission | Amendment |
|---|---|
| (9a) ‘a common specification’ means a set of technical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a product, device, service, process or system;; | deleted |
| (This deletion applies throughout the entire COM(2025)0504.) |
| Text proposed by the Commission | Amendment |
|---|---|
| (9a) ‘a common specification’ means a set of technical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a product, device, service, process or system;; | (9a) ‘common specification’ means a technical specification, other than a standard, that provide a means of complying with the essential requirements applicable to a product, device, service, process or system ’; |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Peer evaluation shall ascertain whether the national accreditation bodies meet the requirements laid down in Article 8, taking into account the relevant harmonised standards or common specifications referred to in Article 11.; | 5. Peer evaluation shall ascertain whether the national accreditation bodies meet the requirements laid down in Article 8, taking into account the relevant harmonised standards referred to in Article 11.; |
| (This deletion applies throughout the entire COM(2025)0504.) |
| Text proposed by the Commission | Amendment |
|---|---|
| (17a) ‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached or engaged without the need to register or to download an application;; | (17a) ‘digital contact’ means any up-to-date and freely accessible online communication channel through which economic operators can be reached or engaged without the need to register or to download ore use additional applications related to the economic operator;; |
| (Horizontal amendment. This amendment replaces the definition of digital contact in all the corresponding amending provisions contained in Article 2 Regulation (EU) 2016/424 ; Article 3 Regulation (EU) 2016/425 ; Article 5 Regulation (EU) 2023/1230; Article 6 Regulation (EU) 2023/1542 ; Article 7 Regulation (EU) 2024/1781.) |
| Text proposed by the Commission | Amendment |
|---|---|
| (17a) ‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached or engaged without the need to register or to download an application;; | (17a) ‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached or engaged without the need to register with, or download an application from, the economic operator; |
| Text proposed by the Commission | Amendment |
|---|---|
| (17a) ‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached or engaged without the need to register or to download an application;; | (17a) ‘digital contact’ means any up-to-date and freely accessible online communication channel through which economic operators can be contacted without the need to register or to download or use additional applications specific to the economic operator.; |
This AM applies to the following articles as well: Article 3 paragraph 1a, Article 4 paragraph 1a, Article 5 paragraph 1, Article 6 paragraph 1, Article 7 paragraph 1.
| Text proposed by the Commission | Amendment |
|---|---|
| (19a) ‘common specifications’ means a set of technical requirements, other than a standard, that provide means of complying with the essential requirements applicable to a product, device, service, process or system;; | (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; |
| Text proposed by the Commission | Amendment |
|---|---|
| (19a) ‘common specifications’ means a set of technical requirements, other than a standard, that provide means of complying with the essential requirements applicable to a product, device, service, process or system;; | (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 subsystem or safety component;; |
| Text proposed by the Commission | Amendment |
|---|---|
| Where compliance of a subsystem or a safety component with the applicable requirements has been demonstrated by the procedure referred to in the first subparagraph, manufacturers shall draw up an EU declaration of conformity, in electronic form, and affix the CE marking.; | 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 referred to in Article 19, in electronic form, and affix the CE marking referred to in Article 20.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 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 reached.; | 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.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 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 reached.; | Manufacturers shall indicate on the subsystem or the safety component their name, registered trade name or registered trademark as well as their postal address or 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 reached. |
| Text proposed by the Commission | Amendment |
|---|---|
| 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 reached.; | Manufacturers shall indicate on the subsystem or the safety component their name, registered trade name or registered trademark as well as their postal address or 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 reached.; |
| Text proposed by the Commission | Amendment |
|---|---|
| Manufacturers shall ensure that the subsystem or the safety component is accompanied by the internet address or machine-readable code through which the EU declaration of conformity can be accessed and by the instructions and safety information, in a language which can be easily understood by end-users, as determined by the Member State concerned. The instructions and safety information may be provided in electronic form. Such instructions and safety information shall be clear, understandable and intelligible. | 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 end-users, as determined by the Member State concerned. The instructions and safety information may be provided in electronic form. Such instructions and safety information shall be clear, understandable and intelligible. |
| (Horizontal amendment. This amendment clarifies that authorities should not have to navigate through intermediate steps to reach the specific EU declaration of conformity in all corresponding provisions contained in Article 2 Regulation (EU) 2016/424; Article 3 Regulation (EU) 2016/425; Article 4 Regulation (EU) 2016/426.) |
| Text proposed by the Commission | Amendment |
|---|---|
| Manufacturers shall ensure that the subsystem or the safety component is accompanied by the internet address or machine-readable code through which the EU declaration of conformity can be accessed and by the instructions and safety information, in a language which can be easily understood by end-users, as determined by the Member State concerned. The instructions and safety information may be provided in electronic form. Such instructions and safety information shall be clear, understandable and intelligible. | 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. |
"Directly" should be added in the following articles as well: Article 2 paragraph 2d, 4a, 5a, 11, Article 3 paragraph 2d, Article 4 paragraph 2c, 2c, 4a, 4c, 5a, 9a, 12, Article 5 paragraph 2b, 3b, 7a, ANNEX II paragraph 1b, ANNEX IV paragraph 1a.
| Text proposed by the Commission | Amendment |
|---|---|
| The manufacturer shall take into account the intended use and the foreseeable end-user of the product when deciding the specific format for the instructions and safety information. When drafting the safety information, the manufacturers shall take account of the intended use and foreseeable misuse by the end-user, as well as the role which the instructions play for ensuring safety. | The manufacturer shall take into account the intended use and the foreseeable end-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. |
| Text proposed by the Commission | Amendment |
|---|---|
| However, where a large number of subsystems or safety components are delivered to a single economic operator or end-user, the batch or consignment concerned may be accompanied by a single internet address or machine-readable code through which the EU declaration of conformity can be accessed. | 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 accessed. |
| Text proposed by the Commission | Amendment |
|---|---|
| When the instructions, referred to in the first subparagraph, are provided in electronic form the manufacturer shall: | When the instructions and safety information, referred to in the first subparagraph, are provided in electronic form the manufacturer shall: |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) present them in a format that makes it possible for the end-user to print and download the instructions and save them on an electronic device so that the end-user can access them at all times, in particular during a breakdown of the subsystem or the safety component; this requirement also applies where the instructions are embedded in the software of the subsystem or the safety component; | (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 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; |
| Text proposed by the Commission | Amendment |
|---|---|
| However, the end-user may, at time of the purchase of the product, or up to six months after that purchase, request the instructions or safety information in paper format. Where the end-user requests those instructions or safety information, the manufacturer shall provide them to the end-user, free of charge, within one month of receiving the request.; | 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. The end-user shall be able to make such a request through accessible means of communication, including by telephone, in addition to any potential online channel made available by the manufacturer. 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 end-user shall be clearly informed, in the safety information, of their right to request the instructions for use in paper format. The possibility for the end-user to request the instructions or safety information in paper format shall not preclude manufacturers from providing supplementary information materials in electronic-only formats, such as videos or audio content, which cannot be reproduced in a paper format. In case of any differences between the content of the paper format and that of the materials provided in electronic form, the paper format shall in itself be clear, understandable and intelligible, and sufficient to ensure the safe and proper use of the subsystem or safety component.; |
This AM applies to the following articles as well: Article 3 paragraph 2d, Article 4 paragraph 2c, Article 6 paragraph 4a.
| Text proposed by the Commission | Amendment |
|---|---|
| However, the end-user may, at time of the purchase of the product, or up to six months after that purchase, request the instructions or safety information in paper format. Where the end-user requests those instructions or safety information, the manufacturer shall provide them to the end-user, free of charge, within one month of receiving the request.; | However, the end-user may, at time of the purchase of the product, or up to two years after that purchase, request the instructions or safety information in paper format. The end-user shall be able to make such a request through accessible means of communication, including by telephone, in addition to any potential online channel made available by the manufacturer. Where the end-user requests those instructions or safety information, the manufacturer shall provide them to the end-user, free of charge, within two weeks of receiving the request. The end-user shall be clearly informed, in the safety information, of his or her right to request the instructions for use in paper format. The possibility for the end-user to request the instructions or safety information in paper format shall not preclude manufacturers from providing supplementary information materials in electronic-only formats, such as videos or audio content, which cannot be reproduced in a paper format. In case of any differences between the content of the paper format and that of the materials provided in electronic form, the paper format shall in itself be clear, understandable and intelligible, and sufficient to ensure the safe and proper use of the product.; |
| (Horizontal amendment. This amendment changes the deadlines to request instructions or safety information in paper format and adds further clarifications in all the corresponding amending provisions contained in Article 2 Regulation (EU) 2016/424 ; Article 3 Regulation (EU) 2016/425 ; Article 4 Regulation (EU) 2016/426 ; Article 6 Regulation (EU) 2023/1542.) |
| Text proposed by the Commission | Amendment |
|---|---|
| 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.; | Importers shall indicate on the subsystem or the safety component their name, registered trade name or registered trademark as well as their postal address or digital contact or, where that is not possible, on its packaging or in a document accompanying the subsystem or safety component.; |
| Text proposed by the Commission | Amendment |
|---|---|
| Before making a subsystem or a safety component available on the market, distributors shall verify that the subsystem or the safety component bears the CE marking and that it is accompanied by the internet address or machine-readable code through which the EU declaration of conformity can be accessed and by the instructions and safety information and, where appropriate, by other required documents, in a language which can be easily understood by end-users as determined by the Member State concerned, and that the manufacturer and the importer have complied with the requirements set out in Article 11(5) and (6) and Article 13(3) respectively.; | Before making a subsystem or a safety component available on the market, distributors shall verify that the subsystem or the safety component bears the CE marking and that it is accompanied by the internet address or machine-readable code through which the EU declaration of conformity can be accessed and by the instructions and safety information 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.; |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 17a | deleted |
| (This deletion applies throughout the entire COM(2025)0504) |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission may by means of implementing acts adopt common specifications that enable compliance with the essential requirements set out in Annex II in any of the following cases: | The Commission may, adopt implementing acts, establishing common specifications covering requirements that provide a means to comply with the requirements set out in Article 4. Those implementing acts shall only be adopted where the following conditions are fulfilled: |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission may by means of implementing acts adopt common specifications that enable compliance with the essential requirements set out in Annex II in any of the following cases: | In exceptional cases, 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: |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission may by means of implementing acts adopt common specifications that enable compliance with the essential requirements set out in Annex II in any of the following cases: | The Commission may by means of implementing acts adopt common specifications that enable compliance with the essential requirements set out in Annex II. Those implementing acts shall only be adopted where the following conditions are fulfilled: |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) requirements set out in Annex II are not covered by harmonised standards, or parts thereof, the references of which have been published in the Official Journal of the European Union; | (a) the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft a harmonised standard for the essential health and safety requirements set out in Annex III and: |
| (i) the request has not been accepted; or | |
| (ii) the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or | |
| (iii) the harmonised standards do not comply with the request; and |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) requirements set out in Annex II are not covered by harmonised standards, or parts thereof, the references of which have been published in the Official Journal of the European Union; | (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; |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) requirements set out in Annex II are not covered by harmonised standards, or parts thereof, the references of which have been published in the Official Journal of the European Union; | (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; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) requirements set out in Annex II are covered by harmonised standards, or parts thereof, the references of which have been published in the Official Journal of the European Union, but application of those standards or parts thereof result in non-compliance of a product with the essential requirements set out in Annex II; or | (b) the Commission has requested, pursuant to Article 10(1) of Regulation 1025/2012, one or more European standardisation organisations to draft or to revise European standards for those requirements and: |
| (1) the request has not been accepted by any of the European standardisation organisations to which the request was addressed; or | |
| (2) 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) have not been adopted within the deadline set in the request; or | |
| (b) do not comply with the request; or | |
| (c) do not satisfy the requirements they aim to cover. |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) requirements set out in Annex II are covered by harmonised standards, or parts thereof, the references of which have been published in the Official Journal of the European Union, but application of those standards or parts thereof result in non-compliance of a product with the essential requirements set out in Annex II; or | (b) the Commission has requested, pursuant to Article 4 10(1) of Regulation (EU) No 1025/2012, one or more standardisation organisations to draft or to revise European standards for those requirements; and: |
| (1) the request has not been accepted by any of the European standardisation organisations to which the request was addressed; or | |
| (2) the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) requirements set out in Annex II are covered by harmonised standards, or parts thereof, the references of which have been published in the Official Journal of the European Union, but application of those standards or parts thereof result in non-compliance of a product with the essential requirements set out in Annex II; or | (b) no reference to harmonised standards covering the relevant essential health and safety requirements set out in Annex III has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable period. |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) where the Commission considers that there is a need to address an urgent concern with regard to non-compliant subsystems and safety components. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) where the Commission considers that there is a need to address an urgent concern with regard to non-compliant subsystems and safety components. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) where the Commission considers that there is a need to address an urgent concern with regard to non-compliant subsystems and safety components. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) where the Commission considers that there is a need to address an urgent concern with regard to non-compliant subsystems and safety components. | (c) where the Commission, as a last resort, considers that there is a need to address an urgent concern with regard to non-compliant subsystems and safety components. |
| For the purposes of point (c) of the first subparagraph, a situation shall be considered to constitute an urgent concern in particular when there is evidence of a serious or imminent risk to the health or safety of persons, the protection of the environment, or the functioning of the internal market, which cannot be adequately mitigated by alternative measures, or when the time required to adopt harmonised standards would likely result in significant harm to one or more of the above. | |
| (Horizontal amendment. This amendment replaces par. 1 point c) on common specifications in all the corresponding amending provisions contained in Article 2 Regulation (EU) 2016/424; Article 3 Regulation (EU) 2016/425; Article 4 Regulation (EU) 2016/426.) |
| Text proposed by the Commission | Amendment |
|---|---|
| Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 44(2). | Those implementing acts shall be developed in accordance with the principles of Annex II 3(a), (b) and (c) of Regulation (EU) 1025/2012 and adopted in accordance with the advisory procedure referred to in Article 44(2). |
| Text proposed by the Commission | Amendment |
|---|---|
| Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 44(2). | Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(3). |
| Text proposed by the Commission | Amendment |
|---|---|
| Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 44(2). | Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(3). |
| Text proposed by the Commission | Amendment |
|---|---|
| 1 a. When preparing the draft implementing act referred to in paragraph 1 of this Article, the Commission shall take into account the views of the relevant bodies and, where applicable, of the Expert Groups and shall duly consult all relevant stakeholders. | |
| (Horizontal amendment. This amendment adds a paragraph to the article on common specifications in all the corresponding amending provisions contained in Article 2 Regulation (EU) 2016/424; Article 3 Regulation (EU) 2016/425; Article 4 Regulation (EU) 2016/426.) |
| Text proposed by the Commission | Amendment |
|---|---|
| 1 b. When the European Parliament considers that a common specification does not entirely satisfy the relevant requirements, 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. | |
| (Horizontal amendment. This amendment adds a paragraph to the article on common specifications in all the corresponding amending provisions contained in Article 2 Regulation (EU) 2016/424; Article 3 Regulation (EU) 2016/425; Article 4 Regulation (EU) 2016/426.) |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 a. Before preparing the draft of the implementing act referred to in paragraph 1 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 paragraph 1 of this Article are fulfilled. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 a. Before preparing the draft implementing act referred to in paragraph 1, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 1 have been fulfilled. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 b. When preparing the draft implementing act referred to in paragraph 1, the Commission shall take into account the views of the assigned Expert Group as well as any other relevant bodies, and shall duly consult all relevant stakeholders. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 b. When preparing the draft of the implementing acts referred to in paragraph 1, the Commission shall take into account the views of the assigned Expert Group. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 c. 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 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 paragraph 1, or parts thereof which cover the same requirements as those covered by that harmonised standard. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 c. Where a harmonised standard is adopted by a European standardization 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 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 paragraph 1, or parts thereof which cover the same requirements as those covered by that harmonised standard. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 d. When a Member State 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.’;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 d. When a Member State or the European Parliament considers that a common specification does not entirely satisfy the essential requirements set out in Annex II, 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. |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) appropriate knowledge and understanding of the essential requirements set out in Annex II, of the applicable harmonised standards or common specifications and of the relevant provisions of Union harmonisation legislation and of national legislation;; | deleted |
| (This deletion applies throughout the entire COM(2025)0504) |
| Text proposed by the Commission | Amendment |
|---|---|
| (10) in Article 34, paragraph 3 is replaced by the following: | deleted |
| ‘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.;’ | |
| (This deletion applies throughout the entire COM(2025)0504) |
| Text proposed by the Commission | Amendment |
|---|---|
| (8a) ‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached or engaged without the need to register or to download an application;; | (8a) ‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached or involved without the need to register with, or download an application from, the economic operator; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the following point (10a) is inserted: | deleted |
| ‘(10a) ‘common specifications’ means a set of technical requirements, other than a standard, that provides a means of complying with the essential requirements applicable to a product, device, service, process or system;;’ | |
| (This deletion applies throughout the entire COM(2025)0504) |
| Text proposed by the Commission | Amendment |
|---|---|
| (10a) ‘common specifications’ means a set of technical requirements, other than a standard, that provides a means of complying with the essential requirements applicable to a product, device, service, process or system;; | (10a) ‘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 PPE. |
| Text proposed by the Commission | Amendment |
|---|---|
| (10a) ‘common specifications’ means a set of technical requirements, other than a standard, that provides a means of complying with the essential requirements applicable to a product, device, service, process or system;; | (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;; |
| Text proposed by the Commission | Amendment |
|---|---|
| Manufacturers shall indicate, on the PPE, their name, registered trade name or registered trademark as well as their postal address and digital contact or, where that is not possible, on its packaging or in a document accompanying the PPE. The postal address and digital contact shall indicate a single point through which the manufacturer can be reached.; | 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.; |
| Text proposed by the Commission | Amendment |
|---|---|
| Manufacturers shall indicate, on the PPE, their name, registered trade name or registered trademark as well as their postal address and digital contact or, where that is not possible, on its packaging or in a document accompanying the PPE. The postal address and digital contact shall indicate a single point through which the manufacturer can be reached.; | ‘Manufacturers shall indicate, on the PPE, their name, registered trade name or registered trademark as well as their postal address or digital contact or, where that is not possible, on its packaging or in a document accompanying the PPE. The postal address and digital contact shall indicate a single point through which the manufacturer can be reached. |
| Text proposed by the Commission | Amendment |
|---|---|
| Manufacturers shall indicate, on the PPE, their name, registered trade name or registered trademark as well as their postal address and digital contact or, where that is not possible, on its packaging or in a document accompanying the PPE. The postal address and digital contact shall indicate a single point through which the manufacturer can be reached.; | Manufacturers shall indicate, on the PPE, their name, registered trade name or registered trademark as well as their postal address or digital contact or, where that is not possible, on its packaging or in a document accompanying the PPE. The postal address and digital contact shall indicate a single point through which the manufacturer can be reached.; |
| Text proposed by the Commission | Amendment |
|---|---|
| In the case of PPE intended for consumers or that can, under reasonably foreseeable conditions, be used by consumers, even if not intended for them, the manufacturer shall provide, in paper format, or make them visible on the packaging, the instructions and information set out in point 1.4 of Annex II.. Such information shall be easily visible and legible for consumers. | In the case of PPE intended for consumers or that can, under reasonably foreseeable conditions, be used by consumers, even if not intended for them, the manufacturer shall provide, in paper format, or make them visible on the packaging, the instructions and information set out in point 1.4 of Annex II, which are related to the safe use of the PPE. Such information shall be easily visible and legible for consumers including for persons with disabilities. |
| Text proposed by the Commission | Amendment |
|---|---|
| In the case of PPE intended for consumers or that can, under reasonably foreseeable conditions, be used by consumers, even if not intended for them, the manufacturer shall provide, in paper format, or make them visible on the packaging, the instructions and information set out in point 1.4 of Annex II.. Such information shall be easily visible and legible for consumers. | In the case of PPE intended for consumers or that can, under reasonably foreseeable conditions, be used by consumers, even if not intended for them, the manufacturer shall provide, in paper format, or make them visible on the packaging, the instructions and information set out in point 1.4 of Annex II.. Such information shall be easily visible and legible for consumers, including for persons with disabilities. |
| (Horizontal amendment. This amendment adds the clarification that when instructions and safety information are provided in paper format, they need to be accessible for persons with disabilities in all the corresponding amending provisions contained in Article 3 Regulation (EU) 2016/425; Article 4 Regulation (EU) 2016/426; Article 6 Regulation (EU) 2023/1542.) |
| Text proposed by the Commission | Amendment |
|---|---|
| In the case of PPE intended for consumers or that can, under reasonably foreseeable conditions, be used by consumers, even if not intended for them, the manufacturer shall provide, in paper format, or make them visible on the packaging, the instructions and information set out in point 1.4 of Annex II.. Such information shall be easily visible and legible for consumers. | In the case of PPE intended for consumers or that can, under reasonably foreseeable conditions, be used by consumers, even if not intended for them, the manufacturer shall provide, in paper format, or make them visible on the packaging, the instructions and information set out in point 1.4 of Annex II. Such safety information shall be easily accessible and legible for consumers and for other end-users. |
| Text proposed by the Commission | Amendment |
|---|---|
| In the case of PPE intended for consumers or that can, under reasonably foreseeable conditions, be used by consumers, even if not intended for them, the manufacturer shall provide, in paper format, or make them visible on the packaging, the instructions and information set out in point 1.4 of Annex II.. Such information shall be easily visible and legible for consumers. | 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, upon request from the consumer, or make them visible on the packaging, the instructions and information set out in point 1.4 of Annex II.. Such information shall be easily visible and legible for consumers. |
| Text proposed by the Commission | Amendment |
|---|---|
| When drafting the instructions and information set out in point 1.4 of Annex II, the manufacturers shall take account of the intended use and foreseeable misuse by the end-user. | When 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. |
| Text proposed by the Commission | Amendment |
|---|---|
| When the instructions, referred to in the first subparagraph, are provided in electronic form, the manufacturer shall: | When the instructions and information, referred to in the first subparagraph, are provided in electronic form, the manufacturer shall: |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) present them in a format that makes it possible for the end-user to print and download the instructions and save them on an electronic device so that the end-user can access them at all times, in particular during a breakdown of the PPE; this requirement also applies where the instructions are embedded in the software of the PPE; | (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; |
| Text proposed by the Commission | Amendment |
|---|---|
| Importers shall indicate, on the PPE, their name, registered trade name or registered trademark as well as their postal address and digital contact through which they can be reached or, where that is not possible, on its packaging or in a document accompanying the PPE.; | Importers shall ensure that the PPE is accompanied by the instructions and information set out in point 1.4 of Annex II or that they are provided in electronic form in accordance with Article 8(7) in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. Where the instructions and information set out in point 1.4 of Annex II are provided in electronic form importers shall ensure that the manufacturer has complied with the relevant requirements set out in Article 8(7). The end-user may, at time of the purchase of the PPE, or up to six months after that purchase, request the instructions and information set out in point 1.4 of Annex II in paper format and the importer shall ensure that they are provided free of charge and within one month of receiving the request. |
The obligations of importers in relation to instructions and information must take into account the possibility of the manufacture to provide them either on paper or in electronic form. Where the manufacturer provides the instructions and information in electronic form he has to comply with certain requirements, including the obligation to provide them in paper format upon request. The importer has to ensure that the manufacturer complies with such obligations in order effective access to the instructions and information to be possible when the manufacturer is not in the Union
| Text proposed by the Commission | Amendment |
|---|---|
| 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.; | 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 with this regulation in a language which can be easily understood by that authority.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 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.; | Distributors shall, further to a reasoned request from a competent national authority, provide it, in electronic form, with all the information and documentation made available to them by the manufacturer, importer or authorised representative needed to demonstrate the conformity of the PPE.; |
| Text proposed by the Commission | Amendment |
|---|---|
| (5 a) Before making PPE available on the market, distributors shall verify that it bears the CE marking, that it is accompanied by the internet address or machine-readable code through which the EU declaration of conformity can be accessed and by the required documents, that the instructions and information set out in point 1.4 of Annex II are available in accordance with Article 8(7) in a language which can be easily understood by consumers and other end-users as determined by the Member State in which the PPE is to be made available on the market, and that the manufacturer and the importer have complied with the requirements set out in Article 8(5) and (6) and Article 10(3) respectively |
| Text proposed by the Commission | Amendment |
|---|---|
| (6) the following Article 14a is inserted: | deleted |
| ‘Article 14a | |
| Common Specifications | |
| 1. | |
| The Commission may by means of implementing acts adopt common specifications that enable compliance with essential requirements set out in Annex II in any of the following cases: | |
| (a) requirements set out in Annex II are not covered by harmonised standards, or parts thereof, the references of which have been published in the Official Journal of the European Union; | |
| (b) requirements set out in Annex II are covered by harmonised standards, or parts thereof, the references of which have been published in the Official Journal of the European Union, but application of those standards or parts thereof result in non-compliance of PPE with the requirements set out in Annex II, or | |
| (c) where the Commission considers that there is a need to address an urgent concern with regard to non-compliant PPE. | |
| Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 44(2). | |
| 2. PPE that is in conformity with common specifications or parts thereof shall be presumed to be in conformity with the essential requirements covered by those specifications or parts thereof, set out in Annex II.;’ | |
| (This deletion applies throughout the entire COM(2025)0504) |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission may by means of implementing acts adopt common specifications that enable compliance with essential requirements set out in Annex II in any of the following cases: | In exceptional cases, 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: |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission may by means of implementing acts adopt common specifications that enable compliance with essential requirements set out in Annex II in any of the following cases: | The Commission may by means of implementing acts adopt common specifications that enable compliance with essential requirements set out in Annex II. Those implementing acts shall only be adopted where the following conditions are fulfilled: |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) requirements set out in Annex II are not covered by harmonised standards, or parts thereof, the references of which have been published in the Official Journal of the European Union; | (a) the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft a harmonised standard for the essential health and safety requirements set out in Annex III and: |
| (i) the request has not been accepted; or | |
| (ii) the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or | |
| (iii) the harmonised standards do not comply with the request; and |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) requirements set out in Annex II are not covered by harmonised standards, or parts thereof, the references of which have been published in the Official Journal of the European Union; | (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; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) requirements set out in Annex II are covered by harmonised standards, or parts thereof, the references of which have been published in the Official Journal of the European Union, but application of those standards or parts thereof result in non-compliance of PPE with the requirements set out in Annex II, or | (b) the Commission has requested, pursuant to Article 10(1) of Regulation 1025/2012, one or more European standardisation organisations to draft or to revise European standards for those requirements and: |
| (1) the request has not been accepted by any of the European standardisation organisations to which the request was addressed; or | |
| (2) 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) have not been adopted within the deadline set in the request; or | |
| (b) do not comply with the request; or | |
| (c) do not satisfy the requirements they aim to cover. |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) requirements set out in Annex II are covered by harmonised standards, or parts thereof, the references of which have been published in the Official Journal of the European Union, but application of those standards or parts thereof result in non-compliance of PPE with the requirements set out in Annex II, or | (b) no reference to harmonised standards covering the relevant essential health and safety requirements set out in Annex III has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable period. |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) where the Commission considers that there is a need to address an urgent concern with regard to non-compliant PPE. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) where the Commission considers that there is a need to address an urgent concern with regard to non-compliant PPE. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 44(2). | Those implementing acts shall be developed in accordance with the principles of Annex II 3(a), (b) and (c) of Regulation (EU) 1025/2012 and adopted in accordance with the advisory procedure referred to in Article 44(2). |
| Text proposed by the Commission | Amendment |
|---|---|
| Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 44(2). | Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(3). |
| Text proposed by the Commission | Amendment |
|---|---|
| Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 44(2). | Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(3). |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. PPE that is in conformity with common specifications or parts thereof shall be presumed to be in conformity with the essential requirements covered by those specifications or parts thereof, set out in Annex II.; | 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.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 a. Before preparing the draft implementing act referred to in paragraph 1, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 1 have been fulfilled. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 b. When preparing the draft implementing act referred to in paragraph 1, the Commission shall take into account the views of the assigned Expert Group as well as any other relevant bodies, and shall duly consult all relevant stakeholders. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 c. Where a harmonised standard is adopted by a European standardization 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 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 paragraph 1, or parts thereof which cover the same requirements as those covered by that harmonised standard. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 d. When a Member State or the European Parliament considers that a common specification does not entirely satisfy the essential requirements set out in Annex II, 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. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Where other Union legislation applicable to the PPE requires the economic operator to include the information that the product complies with the requirements set out in that legislation in a digital product passport or to upload the EU declaration of conformity or instructions in a digital product passport, the information required in Annex IX to be included in the EU declaration of conformity and the instructions referred to in Article 8(7) shall be provided only in that digital product passport.; | 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, as appropriate, the EU declaration of conformity required in Article 15, 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 and the instructions referred to in Article 8(7), where provided in electronic form, shall be provided only in that digital product passport.; |
| Text proposed by the Commission | Amendment |
|---|---|
| (10) Article 25 is replaced by the following: | deleted |
| ‘Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or common specifications or parts thereof the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 24 in so far as the applicable harmonised standards cover those requirements.;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (21a) digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached or engaged without the need to register or to download an application; | (21a) ‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached or involved without the need to register with the economic operator or to download an application from the economic operator; |
| Text proposed by the Commission | Amendment |
|---|---|
| (23a) ‘common specifications’ means a set of technical requirements, other than a standard, that provides a means of complying with the essential requirements applicable to a product, device, service, process or system;; | deleted |
| (This deletion applies throughout the entire COM(2025)0504) |
| Text proposed by the Commission | Amendment |
|---|---|
| (23a) ‘common specifications’ means a set of technical requirements, other than a standard, that provides a means of complying with the essential requirements applicable to a product, device, service, process or system;; | (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;; |
| Text proposed by the Commission | Amendment |
|---|---|
| (23a) ‘common specifications’ means a set of technical requirements, other than a standard, that provides a means of complying with the essential requirements applicable to a product, device, service, process or system;; | (23a) ‘common specification’ means a technical specification, other than a standard, that provide means of complying with the essential requirements set out in Annex I applicable to appliances and fittings’; |
| Text proposed by the Commission | Amendment |
|---|---|
| Manufacturers shall indicate on the appliance their name, registered trade name or registered trademark, as well as their postal address and digital contact or, where that is not possible, on the packaging or in a document accompanying the appliance. The postal address and digital contact shall indicate a single point through which the manufacturer can be reached. The contact details shall be in a language easily understood by consumers and other end-users and the market surveillance authorities. | Manufacturers shall indicate on the 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. |
| Text proposed by the Commission | Amendment |
|---|---|
| Manufacturers shall indicate on the appliance their name, registered trade name or registered trademark, as well as their postal address and digital contact or, where that is not possible, on the packaging or in a document accompanying the appliance. The postal address and digital contact shall indicate a single point through which the manufacturer can be reached. The contact details shall be in a language easily understood by consumers and other end-users and the market surveillance authorities. | Manufacturers shall indicate on the appliance their name, registered trade name or registered trademark, as well as their postal address or digital contact or, where that is not possible, on the packaging or in a document accompanying the appliance. The postal address and digital contact shall indicate a single point through which the manufacturer can be reached. The contact details shall be in a language easily understood by consumers and other end-users and the market surveillance authorities. |
| Text proposed by the Commission | Amendment |
|---|---|
| Manufacturers shall indicate on the appliance their name, registered trade name or registered trademark, as well as their postal address and digital contact or, where that is not possible, on the packaging or in a document accompanying the appliance. The postal address and digital contact shall indicate a single point through which the manufacturer can be reached. The contact details shall be in a language easily understood by consumers and other end-users and the market surveillance authorities. | Manufacturers shall indicate on the appliance their name, registered trade name or registered trademark, as well as their postal address or digital contact or, where that is not possible, on the packaging or in a document accompanying the appliance. The postal address and digital contact shall indicate a single point through which the manufacturer can be reached. The contact details shall be in a language easily understood by consumers and other end-users and the market surveillance authorities. |
| Text proposed by the Commission | Amendment |
|---|---|
| Manufacturers shall indicate on the fitting their name, registered trade name or registered trademark, as well as their postal address and digital contact or, where that is not possible, on the packaging or in a document accompanying the fitting. The postal address and digital contact shall indicate a single point through which the manufacturer can be reached. The contact details shall be in a language easily understood by appliance manufacturers and the market surveillance authorities. | 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. |
| Text proposed by the Commission | Amendment |
|---|---|
| Manufacturers shall take into account the intended use and the foreseeable end-user of the product when deciding the specific format for the instructions and safety information. | 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. |
| Text proposed by the Commission | Amendment |
|---|---|
| In the case of appliance or fitting intended for consumers or that can, under reasonably foreseeable conditions, be used by consumers, even if not intended for them, the manufacturer shall provide, in paper format, or mark on the equipment, the safety information. Such safety information shall be easily visible and legible for consumers. | In the case of appliance or fitting intended for consumers or that can, under reasonably foreseeable conditions, be used by consumers, even if not intended for them, the manufacturer shall provide, in paper format, or mark on the equipment, the safety information. Such safety information shall be easily visible and legible for consumers including for persons with disabilities. |
| Text proposed by the Commission | Amendment |
|---|---|
| In the case of appliance or fitting intended for consumers or that can, under reasonably foreseeable conditions, be used by consumers, even if not intended for them, the manufacturer shall provide, in paper format, or mark on the equipment, the safety information. Such safety information shall be easily visible and legible for consumers. | In the case of appliance or fitting intended for consumers or that can, under reasonably foreseeable conditions, be used by consumers, even if not intended for them, the manufacturer shall provide, in paper format, upon request from the consumer, or mark on the equipment, the safety information. Such safety information shall be easily visible and legible for consumers. |
| Text proposed by the Commission | Amendment |
|---|---|
| In the case of appliance or fitting intended for consumers or that can, under reasonably foreseeable conditions, be used by consumers, even if not intended for them, the manufacturer shall provide, in paper format, or mark on the equipment, the safety information. Such safety information shall be easily visible and legible for consumers. | In the case of appliance or fitting intended for consumers or that can, under reasonably foreseeable conditions, be used by consumers, even if not intended for them, the manufacturer shall provide, in paper format, or mark on the equipment, the safety information. Such safety information shall be easily accessible and legible for consumers and for other end-users. |
| Text proposed by the Commission | Amendment |
|---|---|
| Manufacturers shall ensure that the fitting is accompanied by the internet address or machine-readable code through which the EU declaration of conformity can be accessed and the instructions for incorporation or assembly, adjustment, operation and maintenance in accordance with point 1.7 of Annex I, in a language which can be easily understood by appliance manufacturers, as determined by the Member State concerned. The instructions may be provided in electronic form. | Manufacturers shall ensure that the fitting is accompanied by the internet address or machine-readable code through which the EU declaration of conformity can be accessed and that it is accompanied 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. |
| Text proposed by the Commission | Amendment |
|---|---|
| When the instructions, referred to in the first subparagraph, are provided in electronic form, the manufacturer shall: | When the instructions or safety information, referred to in the first subparagraph, are provided in electronic form, the manufacturer shall: |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) mark on the appliance or fitting, or, where that is not possible, on its packaging or in an accompanying document, how to access them and how to request them in paper format; | (a) mark on the appliance, or, where that is not possible, on its packaging or in an accompanying document, how to access them and how to request them in paper format; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) present them in a format that makes it possible for the end-user to print and download the instructions and save them on an electronic device so that the end-user can access them at all times, in particular during a breakdown of the appliance or fitting; | (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; |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) make them accessible online during the expected lifetime of the appliance or fitting and for at least 10 years after the placing on the market of the appliance or fitting. | (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. |
| Text proposed by the Commission | Amendment |
|---|---|
| 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 appliance their name, registered trade name or registered trademark, as well as their postal address or 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. |
| Text proposed by the Commission | Amendment |
|---|---|
| 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.; | Distributors shall, upon a reasoned request from a competent national authority, provide it, in electronic form, with all the information and documentation made available to them by the manufacturer, importer or authorised representative needed to demonstrate the conformity of an appliance or a fitting.; |
| Text proposed by the Commission | Amendment |
|---|---|
| (7) the following Article 13a is inserted: | deleted |
| ‘Article 13a | |
| Common Specifications | |
| 1. | |
| The Commission may by means of implementing acts adopt common specifications that enable compliance with essential requirements set out in Annex I in any of the following cases: | |
| (a) requirements set out in Annex I are not covered by harmonised standards, or parts thereof, the references of which have been published in the Official Journal of the European Union; | |
| (b) requirements set out in Annex I are covered by harmonised standards, or parts thereof, the references of which have been published in the Official Journal of the European Union, but application of those standards or parts thereof result in non-compliance of appliances and fittings with the requirements set out in Annex I, or | |
| (c) where the Commission considers that there is a need to address an urgent concern with regard to non-compliant subsystems and safety components. | |
| Those implementing acts shall be adopted in accordance with the advisory procedure as provided for in Article 42(2). | |
| 2. Appliances and fittings that are in conformity with common specifications or parts thereof shall be presumed to be in conformity with the essential requirements covered by those specifications or parts thereof, set out in Annex I.;’ | |
| (This deletion applies throughout the entire COM(2025)0504) |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission may by means of implementing acts adopt common specifications that enable compliance with essential requirements set out in Annex I in any of the following cases: | In exceptional cases, 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 |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission may by means of implementing acts adopt common specifications that enable compliance with essential requirements set out in Annex I in any of the following cases: | The Commission may by means of implementing acts adopt common specifications that enable compliance with essential requirements set out in Annex I. Those implementing acts shall only be adopted where the following conditions are fulfilled: |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) requirements set out in Annex I are not covered by harmonised standards, or parts thereof, the references of which have been published in the Official Journal of the European Union; | (a) the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft a harmonised standard for the essential health and safety requirements set out in Annex III and: |
| (i) the request has not been accepted; or | |
| (ii) the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or | |
| (iii) the harmonised standards do not comply with the request; and |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) requirements set out in Annex I are not covered by harmonised standards, or parts thereof, the references of which have been published in the Official Journal of the European Union; | (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; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) requirements set out in Annex I are covered by harmonised standards, or parts thereof, the references of which have been published in the Official Journal of the European Union, but application of those standards or parts thereof result in non-compliance of appliances and fittings with the requirements set out in Annex I, or | (b) the Commission has requested, pursuant to Article 10(1) of Regulation 1025/2012, one or more European standardisation organisations to draft or to revise European standards for those requirements and: |
| (1) the request has not been accepted by any of the European standardisation organisations to which the request was addressed; or | |
| (2) 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) have not been adopted within the deadline set in the request; or | |
| (b) do not comply with the request; or | |
| (c) do not satisfy the requirements they aim to cover. |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) requirements set out in Annex I are covered by harmonised standards, or parts thereof, the references of which have been published in the Official Journal of the European Union, but application of those standards or parts thereof result in non-compliance of appliances and fittings with the requirements set out in Annex I, or | (b) no reference to harmonised standards covering the relevant essential health and safety requirements set out in Annex III has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable period. |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) where the Commission considers that there is a need to address an urgent concern with regard to non-compliant subsystems and safety components. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) where the Commission considers that there is a need to address an urgent concern with regard to non-compliant subsystems and safety components. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| Those implementing acts shall be adopted in accordance with the advisory procedure as provided for in Article 42(2). | Those implementing acts shall be developed in accordance with the principles of Annex II 3(a), (b) and (c) of Regulation (EU) 1025/2012 and adopted in accordance with the advisory procedure as provided for in Article 42(2). |
| Text proposed by the Commission | Amendment |
|---|---|
| Those implementing acts shall be adopted in accordance with the advisory procedure as provided for in Article 42(2). | Those implementing acts shall be adopted in accordance with the examination procedure as provided for in Article 42(3). |
| Text proposed by the Commission | Amendment |
|---|---|
| Those implementing acts shall be adopted in accordance with the advisory procedure as provided for in Article 42(2). | Those implementing acts shall be adopted in accordance with the examination procedure as provided for in Article 42(3). |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Appliances and fittings that are in conformity with common specifications or parts thereof shall be presumed to be in conformity with the essential requirements covered by those specifications or parts thereof, set out in Annex I.; | 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.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 a. Before preparing the draft implementing act referred to in paragraph 1, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 1 have been fulfilled. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 b. When preparing the draft implementing act referred to in paragraph 1, the Commission shall take into account the views of the assigned Expert Group as well as any other relevant bodies, and shall duly consult all relevant stakeholders. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 c. Where a harmonised standard is adopted by a European standardization 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 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 paragraph 1, or parts thereof which cover the same requirements as those covered by that harmonised standard. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 d. When a Member State or the European Parliament considers that a common specification does not entirely satisfy the essential requirements set out in Annex I, 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. |
| Text proposed by the Commission | Amendment |
|---|---|
| (22a) ‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached or engaged without the need to register or to download an application.; | (22a) ‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached or engaged without the need to register with the economic operator or to download an application from the economic operator; |
| Text proposed by the Commission | Amendment |
|---|---|
| (a a) In paragraph 6, the first sentence is replaced by the following: | |
| ‘Manufacturers shall indicate their name, registered trade name or registered trade mark, and the postal address, website and e-mail address or other digital contact at which they can be contacted, on the machinery or related product or, where that is not possible, on its packaging or in a document accompanying the machinery or related product.;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (11 a) Article 20, paragraph 8 is replaced by the following: | |
| When a Member State or the European Parliament consider that a common specification does not entirely satisfy the essential health and safety requirements set out in Annex III, 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. |
| Text proposed by the Commission | Amendment |
|---|---|
| (23a) ‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached or engaged without the need to register or to download an application.; | (23a) ‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached or engaged without the need to register with the economic operator or to download an application from the economic operator; |
| Text proposed by the Commission | Amendment |
|---|---|
| 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. | 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, upon request from the consumer, the safety information. |
| Text proposed by the Commission | Amendment |
|---|---|
| When the instructions are provided in electronic form, the manufacturer shall mark on the battery, or, where that is not possible, on its packaging or in an accompanying document, that they are accessible in the battery passport and how to request them in paper format. | 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. |
| Text proposed by the Commission | Amendment |
|---|---|
| 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.; | Manufacturers shall indicate on the battery their name, registered trade name or registered trademark as well as their postal address or digital contact, indicating a single contact point.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 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.; | Importers shall indicate on the battery their name, registered trade name or registered trademark as well as their postal address or digital contact, indicating a single contact point.; |
| Text proposed by the Commission | Amendment |
|---|---|
| (9 a) In Article 16, paragraph 3a (new) is added: | |
| When a Member States or the European Parliament consider that a common specification does not entirely satisfy the requirements, they 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. |
| Text proposed by the Commission | Amendment |
|---|---|
| (46a) ‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached or engaged without the need to register or to download an application;; | (46a) ‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached or engaged without the need to register with the economic operator or to download an application from the economic operator; |
| Text proposed by the Commission | Amendment |
|---|---|
| (6 a) n Article 36(2), second subparagraph, the second sentence 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.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. Within three years of the entry into force of this Directive, the Commission shall publish a report on the effectiveness of the digital information on the safety of products designed for consumers. The Commission shall review this Directive five years after its entry into force in light of that report and shall publish the results of this review including, where relevant, a draft proposal revising the Directive. |
| Text proposed by the Commission | Amendment |
|---|---|
| (7 a) n Article 79(1), point (a)(i) is replaced by the following: | |
| ‘until 31 December 2028, as regards photovoltaic panels, space and combination heaters, water heaters, solid fuel local space heaters, air conditioners including air-toair 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; ’ |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 7a | |
| Amendments to Regulation (EU) No. 2025/… on the safety of toys and repealing Directive 2009/48/EC | |
| In Article 14, paragraph 3a is added: | |
| ‘ When a Member State or the European Parliament consider that a common specification or parts thereof does not entirely satisfy the essential requirements set out in Annex I which it covers, they 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.’;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 5 and Annex IV shall apply from 20 January 2027. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| The following provisions shall apply from [OP: please insert 24 months after entry into force of this amending Regulation]: | The following provisions shall apply from [OP: please insert 36 months after entry into force of this amending Regulation]: |
| Text proposed by the Commission | Amendment |
|---|---|
| (c a) Article 5 and Annex IV |
| Text proposed by the Commission | Amendment |
|---|---|
| 4.3 a. 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;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard or common specification.; | deleted |
The proposed amendments are not correct. Common specifications provide means of complying only with the essential requirements applicable to products covered by the relevant Regulation. Common specifications do not cover the requirements applicable to the quality system of the manufacturer and cannot provide presumption of conformity with such requirements.
| Text proposed by the Commission | Amendment |
|---|---|
| It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard or common specification.; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) in point 3.3., the second subparagraph is replaced by the following: | deleted |
| ‘It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard or common specification.;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard or common specification.; | deleted |
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Sources & citation
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- Data source
- Licensed CC BY 4.0.
- Retrieved
- 25 September 2026
Cite as
European Parliament (2025). “AMENDMENTS 1 - 167 - Draft opinion Amending Regulations (EU) No 765/2008, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2023/1230, (EU) 2023/1542 and (EU) 2024/1781 as regards digitalisation and common specifications”. Text, 24 October 2025. docId IMCO-AM-779374. EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/IMCO-AM-779374 (retrieved 25 September 2026). Data: EP Open Data API: document record, https://data.europarl.europa.eu/api/v2/documents/IMCO-AM-779374 (CC BY 4.0).
BibTeX
@misc{epw-text-imco-am-779374,
author = {{European Parliament}},
title = {{AMENDMENTS 1 - 167 - Draft opinion Amending Regulations (EU) No 765/2008, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2023/1230, (EU) 2023/1542 and (EU) 2024/1781 as regards digitalisation and common specifications}},
year = {2025},
date = {2025-10-24},
howpublished = {\url{https://news.eu-parl.st-solutions.dev/texts/IMCO-AM-779374}},
url = {https://news.eu-parl.st-solutions.dev/texts/IMCO-AM-779374},
urldate = {2026-09-25},
publisher = {EU Parl Watch Research},
note = {Text. docId IMCO-AM-779374. Data: EP Open Data API: document record (CC BY 4.0)}
}