Obligations of manufacturers
1. When placing products covered by a delegated act adopted pursuant to Article 4 on the market or putting them into service, manufacturers shall ensure that:
(a)
those products have been designed and manufactured in accordance with the performance requirements set out in the delegated acts adopted pursuant to Article 4;
(b)
those products are accompanied by the information required under Article 7 and the delegated acts adopted pursuant to Article 4; and
(c)
a digital product passport is available in accordance with Article 9 and the delegated acts adopted pursuant to Article 4, including a back-up copy of the most up-to-date version of the digital product passport stored by a digital product passport service provider in accordance with Article 10(4).
2. Before placing a product covered by a delegated act adopted pursuant to Article 4 on the market or putting it into service, manufacturers shall carry out the conformity assessment procedure specified in that delegated act, or have it carried out on their behalf, and draw up the required technical documentation.
Where compliance of a product covered by a delegated act adopted pursuant to Article 4 with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EU declaration of conformity in accordance with Article 44 and affix the CE marking in accordance with Article 46. However, where the Commission has specified alternative rules pursuant to Article 4(6), point (d), the manufacturer shall affix conformity marking in accordance with those rules.
3. Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after a product covered by a delegated act adopted pursuant to Article 4 has been placed on the market or put into service, unless a different period has been specified in that delegated act.
4. Manufacturers shall ensure that procedures are in place to ensure that products covered by a delegated act adopted pursuant to Article 4 which are part of a series production remain in conformity with the applicable requirements. Changes in the production process, product design or in characteristics, as well as changes in harmonised standards, common specifications or other technical specifications by reference to which product conformity is declared or through the application of which its conformity is verified, shall be adequately taken into account by manufacturers and, in the event they find that the product’s conformity is affected by such changes, manufacturers shall carry out a reassessment in accordance with the applicable conformity assessment procedure as referred to in paragraph 2, or have that reassessment carried out on their behalf.
5. Manufacturers shall ensure that their products covered by a delegated act adopted pursuant to Article 4 bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the product does not so allow, that the required information is provided on the packaging or in a document accompanying the product.
6. For products covered by a delegated act adopted pursuant to Article 4, manufacturers shall indicate their name, registered trade name or registered trade mark, postal address at which, and electronic means of communication through which, they can be contacted:
(a)
on the public part of the digital product passport, where applicable; and
(b)
on the product or, where that is not possible, on its packaging, or in a document accompanying the product.
The address shall indicate a single point where the manufacturer can be contacted. The contact details shall be clear, understandable and legible.
7. Manufacturers shall ensure that a product covered by a delegated act adopted pursuant to Article 4 is accompanied by instructions in digital format concerning the product (‘digital instructions’) in a language that can be easily understood, as determined by the Member State concerned. Digital instructions shall be clear, understandable and legible and include at least the information set out in Article 7(2), point (b)(ii), as specified in that delegated act.
However, manufacturers shall provide in paper, in a concise format, safety information and the instructions relevant for the health and safety of customers and other relevant actors.
When providing the digital instructions, the manufacturer shall include them in the digital product passport and make them accessible through the corresponding data carrier, or, where the digital product passport is not applicable, indicate on the product, or, where that is not possible, on its packaging or in an accompanying document, how to access the digital instructions.
The manufacturer shall present the digital instructions in a format that makes it possible to download and save them on an electronic device so that the user can access them at all times and shall make them accessible online during the expected lifetime of the product, but in any event for at least 10 years after the placing on the market or putting into service of the product.
Where the customer so requests at the time of the purchase, or up to six months after that purchase, the manufacturer shall provide the digital instructions in a paper format, free of charge, within one month of receiving the request.
The delegated acts adopted pursuant to Article 4 may specify that certain information forming part of the digital instructions is also to be provided in paper format.
8. Manufacturers that consider or have reason to believe that a product covered by a delegated act adopted pursuant to Article 4 that they have placed on the market or put into service is not in conformity with the requirements set out in that delegated act shall without undue delay take the necessary corrective action to bring that product into conformity, or to immediately withdraw or recall it, if appropriate.
Manufacturers shall immediately inform the market surveillance authorities of the Member States in which they made the product available or put it into service of the suspected non-compliance and of any corrective action taken.
9. Manufacturers shall make publicly available communication channels such as a telephone number, electronic address or dedicated section of their website, taking into account the accessibility needs of persons with disabilities, in order to allow customers to submit complaints or concerns regarding the potential non-conformity of products.
Manufacturers shall keep a register of complaints and concerns as long as it is necessary for the purposes of this Regulation, but no longer than five years after they have been submitted and make the register available at the request of a market surveillance authority.
10. Manufacturers shall, for products covered by a delegated act adopted pursuant to Article 4, further to a reasoned request from a competent national authority, provide all the information and documentation necessary to demonstrate the conformity of those products, including the technical documentation, in a language that can be easily understood by that authority. That information and documentation shall be provided in paper or electronic form, as soon as possible and in any event within 15 days of receipt of a request by that authority.
Manufacturers shall cooperate with the competent national authority regarding any corrective action taken to remedy any case of non-compliance with the requirements set out in the applicable delegated act adopted pursuant to Article 4.
Authorised representatives
1. A manufacturer may, by a written mandate, appoint an authorised representative.
The obligations laid down in Article 27(1) and the drawing up of technical documentation shall not form part of the authorised representative’s mandate.
2. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:
(a)
keep the EU declaration of conformity and technical documentation at the disposal of the national market surveillance authorities for 10 years after a product covered by a delegated act adopted pursuant to Article 4 has been placed on the market or put into service unless a different period has been specified in that delegated act;
(b)
cooperate with the competent national authorities, at their request, on any measures taken with regard to cases of non-compliance of the product covered by the authorised representative’s mandate;
(c)
further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product, in a language that can be easily understood by that authority as soon as possible and in any event within 15 days of receipt of such a request; and
(d)
terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
Obligations of importers
1. Importers shall, with regard to products covered by a delegated act adopted pursuant to Article 4, only place on the market products that comply with the requirements set out in the applicable delegated acts.
2. Before placing a product covered by a delegated act adopted pursuant to Article 4 on the market, importers shall ensure that:
(a)
the appropriate conformity assessment procedure has been carried out by the manufacturer and that the manufacturer has drawn up the technical documentation;
(b)
the product is accompanied by the information required under Article 7 and the delegated acts adopted pursuant to Article 4; and
(c)
a digital product passport is available in accordance with Article 9 and the delegated acts adopted pursuant to Article 4, including a back-up copy of the most up-to-date version of the digital product passport stored by a digital product passport service provider in accordance with Article 10(4).
The importer shall further ensure that a product covered by a delegated act adopted pursuant to Article 4 bears the required CE marking referred to in Article 45, where applicable, in accordance with the rules and conditions referred to in Article 46, or the alternative conformity marking as laid down in a delegated act adopted pursuant to Article 4(6), point (d), and is accompanied by the required documents, and that the manufacturer has complied with the requirements set out in Article 27(5) and (6).
Where importers consider or have reason to believe that a product is not in conformity with the requirements set out in the applicable delegated acts adopted pursuant to Article 4, they shall not place the product on the market or put it into service until it has been brought into conformity.
3. For products covered by a delegated act adopted pursuant to Article 4, importers shall indicate their name, registered trade name or registered trade mark, postal address at which and electronic means of communication through which they can be contacted:
(a)
on the public part of the digital product passport, where applicable; and
(b)
on the product or, where that is not possible, on the packaging, or in a document accompanying the product.
The contact details shall be clear, understandable and legible.
4. Importers shall ensure that a product covered by a delegated act adopted pursuant to Article 4 is accompanied by digital instructions in a language that can be easily understood, as determined by the Member State concerned. Such instructions shall be clear, understandable and legible and include at least the information set out in Article 7(2), point (b)(ii), as specified in the delegated acts adopted pursuant to Article 4. The obligations laid down in Article 27(7) fourth and fifth subparagraphs, shall apply mutatis mutandis .
5. Importers shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in the applicable delegated act adopted pursuant to Article 4.
6. Importers that consider or have reason to believe that a product covered by a delegated act adopted pursuant to Article 4 that they have placed on the market is not in conformity with the requirements set out in that delegated act shall without undue delay take the necessary corrective action to bring that product into conformity, or to immediately withdraw or recall it, if appropriate.
Importers shall immediately inform the market surveillance authorities of the Member States in which they made the product available of the suspected non-compliance and of any corrective action taken.
7. Importers shall keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request, for 10 years after a product covered by a delegated act adopted pursuant to Article 4 has been placed on the market or put into service, unless a different period has been specified in that delegated act.
8. Importers shall, for products covered by a delegated act adopted pursuant to Article 4, further to a reasoned request from a competent national authority, provide all the information and documentation necessary to demonstrate the conformity of those products, including the technical documentation, in a language that can be easily understood by that authority. That information and documentation shall be provided in paper or electronic form, as soon as possible and in any event within 15 days of receipt of a request by that authority.
Importers shall cooperate with the competent national authority regarding any corrective action taken to remedy any case of non-compliance with the requirements set out in the applicable delegated act adopted pursuant to Article 4.
Obligations of distributors
1. When making a product covered by a delegated act adopted pursuant to Article 4 available on the market, distributors shall act with due care in relation to the requirements set out in the applicable delegated acts.
2. Before making a product covered by a delegated act adopted pursuant to Article 4 available on the market, distributors shall verify that:
(a)
the product bears the CE marking in accordance with Articles 45 and 46 or the conformity marking adopted in accordance with Article 4(6), point (d), and, where relevant, is labelled or is linked to a digital product passport in accordance with that delegated act;
(b)
the product is accompanied by the required documents and by digital instructions in a language that can be easily understood by customers, as determined by the Member State concerned, and that such instructions are clear, understandable and legible and include at least the information set out in Article 7(2), point (b) (ii), as specified in the delegated act adopted pursuant to Article 4; the obligations laid down in Article 27(7), fourth and fifth subparagraphs, shall apply mutatis mutandis ; and
(c)
the manufacturer and the importer have complied with the requirements set out in Article 27(5) and (6) and Article 29(3).
3. Where distributors consider or have reason to believe that a product, before making it available on the market, is not in conformity, or its manufacturer is not complying, with the requirements set out in the applicable delegated acts adopted pursuant to Article 4, they shall not make the product available on the market until the product has been brought into conformity or the manufacturer complies.
Distributors shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in in the applicable delegated acts adopted pursuant to Article 4.
4. Distributors that consider or have reason to believe that a product which they have made available on the market is not in conformity with the requirements set out in the applicable delegated acts adopted pursuant to Article 4 shall ensure that the necessary corrective action to bring that product into conformity, to withdraw or recall it, if appropriate, is taken.
Distributors shall immediately inform the market surveillance authorities of the Member States in which they made the product available of the suspected non-compliance and of any corrective action taken.
5. Distributors shall, further to a reasoned request from a competent national authority, provide all the information and documentation to which they have access and that is necessary to demonstrate the conformity of a product. That information and documentation shall be provided in paper or electronic form, within 15 days of receipt of a request by that authority.
Distributors shall cooperate with the competent national authority regarding any corrective action taken to remedy any case of non-compliance with the applicable delegated act adopted pursuant to Article 4.
Obligations of dealers
1. Dealers shall ensure that their customers and potential customers have access to any relevant information accompanying products, as required by the delegated acts adopted pursuant to Article 4, including in the event of distance selling.
2. Dealers shall ensure that the digital product passport is easily accessible for customers and potential customers, including in the event of distance selling, as set out in Article 9(2), point (e), and specified in the applicable delegated acts adopted pursuant to Article 4.
3. Dealers shall, including in the event of distance selling:
(a)
display to customers and potential customers, in a visible manner, the labels provided in accordance with Article 32(1), point (b) or (c);
(b)
make reference to the information included on the labels provided in accordance with Article 32(1), point (b) or (c), in visual advertisements or in technical promotional material for a specific model, in accordance with the applicable delegated acts adopted pursuant to Article 4; and
(c)
not provide or display other labels, marks, symbols or inscriptions that are likely to mislead or confuse customers and potential customers with regard to the information included on the label regarding ecodesign requirements.
Obligations related to labels
1. Where a delegated act adopted pursuant to Article 4 requires products to have a label as referred to in Article 16, the economic operators placing the products on the market or putting them into service shall:
(a)
ensure that products are accompanied, for each individual unit and free of charge, by printed labels in accordance with that delegated act;
(b)
provide printed labels or digital copies of the label to the dealer free of charge, promptly and in any event within 5 working days of the dealer’s request; and
(c)
ensure that their labels are accurate, and provide technical documentation sufficient to enable the accuracy of their labels to be assessed.
2. Where a delegated act adopted pursuant to Article 4 requires products to have a label as referred to in Article 16, the economic operators making the products available or putting them into service shall:
(a)
make reference to the information included on the label in visual advertisements or in technical promotional material for a specific model, in accordance with the applicable delegated acts adopted pursuant to Article 4;
(b)
not provide or display other labels, marks, symbols or inscriptions that are likely to mislead or confuse customers or potential customers with regard to the information included on the label regarding ecodesign requirements.
Obligations of fulfilment service providers
Fulfilment service providers shall ensure that, for products that they handle that are covered by a delegated act adopted pursuant to Article 4, the conditions during warehousing, packaging, addressing or dispatching do not jeopardise the products’ compliance with that delegated act.
Cases in which obligations of manufacturers apply to importers and distributors
Importers or distributors shall be considered manufacturers for the purposes of this Regulation where they:
(a)
place a product covered by a delegated act adopted pursuant to Article 4 on the market under their name or trademark; or
(b)
modify such a product already placed on the market in a way that affects compliance with the requirements set out in the applicable delegated acts adopted pursuant to Article 4.
Obligations of providers of online marketplaces and online search engines
1. The general obligations provided for in Articles 11 and 30 of Regulation (EU) 2022/2065 shall apply for the purposes of this Regulation.
Without prejudice to the general obligations referred to in the first subparagraph, providers of online marketplaces shall cooperate with the market surveillance authorities, at the request of those authorities and in specific cases, to facilitate any action taken to eliminate or, if that is not possible, to mitigate the non-compliance of a product that is or was offered for sale online through their services.
2. As far as powers conferred by Member States in accordance with Article 14 of Regulation (EU) 2019/1020 are concerned, Member States shall confer on their market surveillance authorities the power, for all products covered by a relevant delegated act adopted pursuant to Article 4, to order a provider of an online marketplace to act against one or more specific items of content referring to a non-compliant product, including by removing them. Such content shall be considered to be illegal content within the meaning of Article 3, point (h), of Regulation (EU) 2022/2065. Market surveillance authorities may, in accordance with Article 9 of Regulation (EU) 2022/2065, issue such orders.
3. Providers of online marketplaces shall establish a single contact point for the purposes of direct communication with Member States’ market surveillance authorities in relation to compliance with this Regulation.
That single contact point may be the same contact point as that referred to in Article 22(1) of Regulation (EU) 2023/988 of the European Parliament and of the Council ( 62 ) or Article 11(1) of Regulation (EU) 2022/2065.
Information obligations of economic operators
1. When making a product covered by a delegated act adopted pursuant to Article 4 available on the market through distance selling, economic operators shall ensure that the product offer clearly and visibly provides at least the following information:
(a)
the name, registered trade name or registered trade mark of the manufacturer, as well as the postal and electronic address where the manufacturer can be contacted;
(b)
in the event that the manufacturer is not established in the Union, the name, postal and electronic address and telephone number of the economic operator established in the Union within the meaning of Article 4(2) of Regulation (EU) 2019/1020; and
(c)
information allowing the identification of the product, including a picture of it, its type and any other product identifier.
2. Economic operators shall, upon a reasoned request, provide the market surveillance authorities with:
(a)
the name of any economic operator that has supplied them with a product falling within the scope of a delegated act adopted pursuant to Article 4;
(b)
the name of any economic operator to whom or to which they have supplied such products, as well as the quantities and exact models of such products.
Economic operators shall ensure that they are able to provide the information referred to in the first subparagraph for 10 years after they have been supplied with the relevant products and for 10 years after they have supplied such products, unless a different period has been specified in the delegated act referred to in paragraph 1. That information shall be provided in paper or electronic form within 15 days of receipt of a request by the market surveillance authority.
3. When requiring manufacturers, their authorised representatives or importers to make parts of the technical documentation related to the relevant product digitally available pursuant to Article 4(6), point (a)(iii), the Commission shall take into account the following criteria:
(a)
the need to facilitate the verification by market surveillance authorities of compliance of manufacturers, their authorised representatives and importers with the applicable requirements; and
(b)
the need to avoid a disproportionate administrative burden for economic operators, in particular for SMEs.
The Commission shall specify the manner in which the relevant parts of the technical documentation are to be made available. Where the digital product passport is available, technical documentation shall be made available through it.
Monitoring and reporting obligations of economic operators
1. When requiring manufacturers, their authorised representatives or importers to make available to the Commission information on the quantities of a product pursuant to Article 4(6), point (b), the Commission shall take into account the following criteria:
(a)
the availability of evidence concerning the market penetration of the relevant product and which is necessary to facilitate the review of delegated acts adopted pursuant to Article 4 applicable to that product;
(b)
the need to avoid a disproportionate administrative burden for economic operators, in particular for SMEs; and
(c)
the usefulness of the information required and the proportionality of that requirement.
The Commission shall specify the period to which the information referred to in the first subparagraph is to relate. That information shall be differentiated per product model.
The Commission shall specify the means through which the relevant information is to be made available and how frequently such information is to be made available.
The Commission shall ensure that the information made available is processed securely and in compliance with Union law.
2. When requiring that a product be able to measure the energy it consumes or its performance in relation to other relevant product parameters referred to in Annex I while in use, pursuant to Article 4(6), point (c)(i), the Commission shall take into account the following criteria:
(a)
the usefulness of in-use data for end users to understand and manage the energy use or performance of the product;
(b)
the technical feasibility of recording in-use data;
(c)
the need to avoid a disproportionate administrative burden for economic operators, in particular for SMEs; and
(d)
the need to ensure that no data allowing the identification of individuals or allowing the inference of individuals’ behaviour are collected.
3. Products covered by a requirement set pursuant to Article 4(6), point (c), shall where appropriate, in line with the criteria in paragraph 2 of this Article, record the in-use data and make such data visible to the end user.
4. When requiring manufacturers, their authorised representatives or importers to collect non-personal in-use data referred to in paragraph 2 of this Article and report such data to the Commission, pursuant to Article 4(6), point (c)(ii), the Commission shall take into account the following criteria:
(a)
the usefulness of non-personal in-use data for the Commission when reviewing ecodesign requirements or assisting market surveillance authorities with statistical information for their risk-based analysis; and
(b)
the need to avoid a disproportionate administrative burden for economic operators, in particular for SMEs.
5. The requirements referred to in paragraph 4 may in particular consist of:
(a)
collecting non-personal in-use data if they can be accessed remotely via the internet, following explicit consent being given by the end user to make those data available; and
(b)
reporting those data to the Commission at least once a year.
Where reporting is required pursuant to point (b) of the first subparagraph, those data shall include, where available, the identification number of the model as registered in the product database referred to in Article 12(1) of Regulation (EU) 2017/1369 and, if relevant to their performance, general geographical information on the products.
6. The Commission shall specify, in the relevant delegated act, the details and format for reporting the non-personal in-use data as referred to in paragraph 4.
7. The Commission shall periodically assess the non-personal in-use data received pursuant to paragraph 4 and shall, where appropriate, publish aggregated datasets.
Requirements on supply chain actors
When specified in the delegated act adopted pursuant Article 4, supply chain actors shall:
(a)
provide, upon request and free of charge, manufacturers, notified bodies and competent national authorities with available relevant information related to the products they supply or the services they provide;
(b)
allow, in the absence of information referred to in point (a), manufacturers to assess the products they supply or the services they provide and give access to relevant documents or facilities to those manufacturers; and
(c)
enable notified bodies and competent national authorities to verify the accuracy of relevant information related to their activities.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
