Obligations of all economic operators
1. The obligations of economic operators under this Chapter are applicable only in relation to products covered by a harmonised technical specification, or to products that have been CE-marked on the basis of a European technical assessment.
2. An economic operator shall take all necessary measures to ensure continued compliance with this Regulation. Where non-compliance of the economic operator or of a product has been stated and corrective action has been requested by a market surveillance authority in accordance with Article 65(1), the economic operator shall submit progress reports to that authority until that authority decides that the corrective action can be closed.
3. An economic operator shall, on request of a competent national authority, identify to that authority any economic operator or other actor:
(a)
who has supplied that economic operator with a product, including components or spare parts of products, and the quantity of that supply, or who has supplied it with a service covered by this Regulation;
(b)
to whom that economic operator has supplied a product, including components or spare parts of products, and the quantity of that supply, or to whom it has supplied a service covered by this Regulation.
When identifying the economic operators or other actors referred to in the first subparagraph, an economic operator shall inform the competent national authority of, at least, the following:
(a)
the contact details, including addresses and email addresses of those economic operators or actors;
(b)
the tax and company registration numbers of those economic operators or actors.
4. An economic operator shall keep all documents and all information referred to in this Chapter at the disposal of competent national authorities for a period of 10 years after the economic operator supplied or was supplied with the product or service in question, unless the documents or the information have been made available through the digital product passport referred to in Article 76. An economic operator shall present the documentation and information within 10 days of receipt of a request by a competent national authority.
5. An economic operator may register itself in its respective national system established in accordance with Article 71(5).
An economic operator shall make available to consumers and users communication channels, including telephone numbers, email addresses or dedicated sections of its website, allowing them to communicate any accident, other incident or safety issue they have experienced with the product.
6. Where an economic operator considers that a non-conforming product presents a risk to health and safety of persons or to the environment, it shall immediately inform thereof the competent national authorities of the Member States in which it made the product available, giving details, in particular, of the non-compliance and of any corrective measures taken. An economic operator may inform the competent national authorities of any other likely infringement of this Regulation of which it becomes aware, of the non-compliance and of any corrective measures taken.
7. An economic operator shall be liable for infringements of this Article or of the Articles in this Chapter related to its activities, in accordance with national law on contractual and extra-contractual liability.
Rights of manufacturers
1. A manufacturer shall have the right to request from its suppliers and service providers the information necessary in relation to their products to fulfil its obligations under this Regulation.
2. If the manufacturer is subject to third-party tasks carried out by a notified body, the manufacturer shall have the right to request from its suppliers or service providers that they permit that notified body to have access to their documentation and to their premises to the extent that the notified body requires such access in order to carry out its tasks.
3. The rights established in paragraph 1 also apply to a manufacturer placing a used or remanufactured product on the market in relation to the supplier of the used product, including the deinstaller where applicable. The information required may include, but is not limited to, information about the previous use of the product and about the process of deinstalling it.
4. A manufacturer shall have the right to request from its suppliers and service providers the data and calculations required under Article 15(2) in relation to the supplies or services provided, including the necessary validation reports issued by a notified body.
Obligations of manufacturers
1. When placing a product on the market, the manufacturer shall determine the product type, respecting the boundaries set up therefor by the definition provided in Article 3, point (27). The manufacturer shall ensure that the product’s performance is assessed in relation to both mandatory essential characteristics and those essential characteristics intended to be declared. If the product is covered by product requirements established by delegated acts referred to in Article 7(1), the manufacturer shall ensure that the product has also been designed and constructed in accordance with those requirements.
A natural or legal person that manufactures a product using 3-D printing shall satisfy the obligations incumbent on manufacturers when placing it on the market. The obligations shall include, but are not limited to, the use of appropriate 3-D datasets, the use of materials compliant with the applicable procedures under this Regulation, and the verification of the compatibility of 3-D datasets, printing material and the printing technology used.
2. Where a product’s compliance with applicable requirements and its performance in relation to essential characteristics referred to in paragraph 1 of this Article have been demonstrated in accordance with the applicable assessment and verification system or systems set out in Annex IX, the manufacturer shall draw up a declaration of performance and conformity in accordance with Articles 13 to 15, affix the CE marking in accordance with Articles 17 and 18 and, when applicable, ensure the availability of spare parts not commonly available in the market, as referred to in paragraph 8 of this Article, and affix the labelling pursuant to paragraph 9 of this Article.
3. The manufacturer shall, as the basis for the declaration of performance and conformity, draw up a technical documentation in which he shall indicate:
(a)
the declared use, which shall fall within the scope of the applicable intended use;
(b)
all the relevant elements necessary to demonstrate performance and conformity;
(c)
information on the procedures in place referred to in paragraph 4 of this Article;
(d)
information on the applicable system or systems set out in Annex IX;
(e)
where relevant, information on the application of simplified procedures applied in accordance with Articles 59 to 61; and
(f)
the calculation of the performance of environmental sustainability in respect of essential characteristics as referred to in Article 15(2).
4. The manufacturer shall ensure that procedures are in place to ensure that products fulfil their declared performance and remain in conformity with this Regulation. Product design, including 3-D datasets, production processes and material used shall be appropriate. Where the product is manufactured in series production, the manufacturer shall ensure that procedures are in place to ensure that it maintains its declared performance and remains in conformity with this Regulation. Changes in the product design, including 3-D datasets, production process and material used shall be appropriate. Changes in the applicable harmonised technical specifications shall be adequately taken into account and, where the performance or conformity of the product is affected, shall trigger a re-assessment in accordance with the relevant assessment procedure.
The manufacturer shall, where deemed appropriate with regard to ensuring the accuracy, reliability and stability of the declared performance and of the conformity of a product, carry out sample testing of products placed or made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls, and shall keep importers and distributors informed thereof.
5. The manufacturer shall ensure that its products bear a manufacturer-specific unique identification code of the product type and, where available, a batch or serial number which is easily visible and legible for users. Where that is not possible on account of the nature of the product, the required information shall be provided on an affixed label, on the packaging or, where that is also not possible, in a document accompanying the product.
The manufacturer shall, in the same way as set out in the first subparagraph, label a product as ‘Only for professional use’ if expertise is needed in order to use it and shall display the label to customers before they are bound by a sales contract, including in the case of distance selling. Products not labelled ‘Only for professional use’ shall be deemed to also be intended for non-professional users and consumers within the meaning of this Regulation and of Regulation (EU) 2023/988.
The manufacturer shall display to customers, in a visible manner, before they are bound by a sales contract, including in the case of distance selling, the information which must be provided pursuant to this Regulation.
6. When making a product available on the market, the manufacturer shall ensure that it is accompanied by general product information, instructions for use and safety information, as set out in Annex IV in a language to be determined by the Member State concerned or, in absence of such determination, in a language which can be easily understood by users.
7. By 18 months after the entry into force of the delegated act referred to in Article 75(1) the manufacturer shall make available a digital product passport referred to in Article 76, through the construction digital product passport system referred to in Article 75, connected to a data carrier referred to in Article 18(2), point (g).
8. In order to ensure the availability of spare parts not commonly available on the market, the Commission is empowered to adopt delegated acts in accordance with Article 89 to supplement this Regulation, by imposing in respect of certain product families and product categories an obligation on manufacturers to make available on the market specific spare parts not commonly available for the products they place on the market.
The obligation established by the delegated acts referred to in the first subparagraph of this paragraph shall apply for a period of 10 years after the last product of the respective type has been placed on the market, unless the delegated act sets a different period.
Manufacturers subject to the obligation laid down in the first paragraph shall offer the spare parts within a reasonably short delivery period, at a reasonable and non-discriminatory price, and shall inform the public thereof.
9. In order to ensure transparency for users and to promote sustainable products, the Commission is empowered to adopt delegated acts in accordance with Article 89 to supplement this Regulation, by establishing specific environmental sustainability labelling requirements for particular product families and product categories when the following conditions are fulfilled:
(a)
the product is typically chosen or purchased by consumers; and
(b)
the product does not have a significantly different overall environmental performance over its life cycle depending on its installation.
The labelling shall be based on the performance of the product, as assessed in accordance with Article 5(1) or Article 6(1), and shall provide consumer-friendly information understandable by non-experts.
10. The delegated acts referred to in paragraph 9 shall determine the way in which the manufacturer is to affix the label, by specifying the following:
(a)
the content of the label;
(b)
the layout of the label, taking into account its visibility and legibility;
(c)
the manner in which the label is to be displayed to customers, including in the case of distance selling;
(d)
where appropriate, the electronic means to be used for generating labels.
11. A manufacturer who considers or has reason to believe that a product which it has placed on the market does not conform to its declared performance or does not comply with this Regulation shall immediately take the necessary corrective measures to bring that product into conformity or compliance, or, if appropriate, to withdraw or recall it. If the issue is linked to a supplied component or an externally provided service, the manufacturer shall inform the supplier or service provider and the manufacturer’s competent national authority.
12. Where the product presents a risk, the manufacturer shall, without undue delay and at the latest within three working days, inform all the authorised representatives, importers, distributors, fulfilment service providers, and online market places involved in its distribution, as well as the competent national authorities of the Member States in which the manufacturer or, to its knowledge, other economic operators made the product available. The manufacturer shall, to that effect, provide all useful details and, in particular, specify the type of the non-compliance, the frequency of accidents or incidents, and the corrective measures taken or recommended. In the case of risks caused by products which have already reached an end user or consumer who cannot be identified or contacted directly, the manufacturer shall, through the media and other appropriate channels, ensuring the widest possible reach, disseminate information about appropriate measures to eliminate or, if not possible, to reduce the risks. Where there is a serious risk the manufacturer shall withdraw and recall the product at its own cost.
Obligations of authorised representatives
1. A manufacturer established in the Union may appoint, by a written mandate, any natural or legal person established within the Union as a single authorised representative. A manufacturer not established in the Union shall appoint a single authorised representative.
The drawing up of technical documentation shall not form part of the authorised representative’s mandate.
2. The 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 declaration of performance and conformity and the technical documentation at the disposal of competent national authorities;
(b)
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 with its declared performance and its compliance with other applicable requirements in this Regulation;
(c)
terminate the contract if the manufacturer has acted contrary to its obligations under this Regulation and inform the manufacturer, the competent national authorities of the Member States where the product is placed on the market and the competent national authority of his own place of business thereof;
(d)
when there is reason to believe that a product is non-compliant or presents a risk, inform the manufacturer and the competent national authorities of the Member States where the product is placed on the market and the competent national authority of the authorised representative thereof; and
(e)
cooperate with the competent national authorities, at their request, in any action taken to eliminate risks posed by, and to remedy non-conformities of, products covered by the mandate of the authorised representative.
3. The authorised representative shall verify at documentary level that:
(a)
the product bears the CE marking, and the labelling in accordance with Article 22(9);
(b)
the product is accompanied by a declaration of performance and conformity, or that declaration is available in accordance with Article 16(1) or (2); and
(c)
the manufacturer has complied with the requirements set out in Article 22(5), (6) and (7).
4. Where an authorised representative identifies a case of non-compliance mentioned in paragraph 3 of this Article, it shall ask the manufacturer to act in accordance with Article 22(11) and (12).
Obligations of importers
1. Importers shall place on the market only products which are compliant with this Regulation.
2. Before placing a product on the market, the importer shall ensure that the product’s compliance with applicable requirements and its performance in relation to relevant essential characteristics have been demonstrated by the manufacturer in accordance with Article 22(1) and (2).
The importer shall ensure that:
(a)
the manufacturer has drawn up the technical documentation referred to in Article 22(3);
(b)
the product bears the CE marking, and the labelling in accordance with Article 22(9);
(c)
the product is accompanied by the declaration of performance and conformity or that the declaration is available in accordance with Article 16(1) or (2); and
(d)
the manufacturer has complied with the requirements set out in Article 22(5), (6) and (7).
3. The importer shall verify that the use of the product has been declared by the manufacturer, and shall ensure that the product is accompanied by general product information, instructions for use and safety information as set out in Annex IV in a language determined by the Member State concerned or, in absence of such determination, in a language which can be easily understood by users. The importer shall display to customers, in a visible manner, before they are bound by a sales contract, including in the case of distance selling, the information which must be provided pursuant to this Regulation or harmonised technical specifications.
4. The importer shall ensure that, while a product is under its responsibility, the conditions of its storage or transport do not jeopardise its conformity with the declaration of performance and conformity, or its compliance with other applicable requirements in this Regulation.
5. Where an importer considers, or has reason to believe, that a product is not in conformity with the declaration of performance and conformity, or not in compliance with other applicable requirements in this Regulation, the importer shall not place the product on the market until it conforms to the accompanying declaration of performance and conformity and it complies with the other applicable requirements of this Regulation, or until the declaration of performance and conformity is corrected. Furthermore, where the product presents a risk, the importer shall inform the manufacturer and the responsible competent national authority thereof.
6. The importer shall indicate its name, registered trade name or registered trade mark, its place of business, its contact address and, where available, electronic means of communication, either on the product or, where that is not possible, on its packaging, or in a document accompanying the product.
7. The importer shall investigate complaints, and, if necessary, keep a register of complaints, of non-conforming products and of product withdrawals or recalls, and shall keep manufacturers and distributors informed of any such monitoring.
8. Importers who consider or have reason to believe that a product, which they have placed on the market, is not in conformity with its declared performance or not in compliance with other applicable requirements in this Regulation, shall immediately take the necessary corrective measures to bring that product into conformity, or, if appropriate, to withdraw or recall it. Furthermore, where the product poses a risk, importers shall immediately inform the competent national authorities of the Member States in which they made the product available on the market to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.
9. Importers selling to end users shall also fulfil the obligations incumbent on distributors.
Obligations of distributors
1. When making products available on the market, distributors shall act with due care in relation to the obligations of this Regulation.
2. Before making a product available on the market, the distributor shall verify that:
(a)
the product bears the CE marking, and the labelling in accordance with Article 22(9), where required;
(b)
the product is accompanied, where required, by a declaration of performance and conformity, or that the declaration is available in accordance with Article 16(2);
(c)
the product is accompanied by general product information, instructions for use and safety information in accordance with Article 22(6), in a language which can be easily understood by end users in the Member State in which the product is to be made available on the market;
(d)
the manufacturer and the importer have complied with the requirements set out in Article 22(5) and (7) and Article 24(6) respectively.
3. The distributor shall display to customers, in a visible manner, before they are bound by a sales contract, including in the case of distance selling, the information which must be provided pursuant to this Regulation.
4. Where a distributor considers or has reason to believe that a product is not in conformity with its declared performance or not in compliance with other applicable requirements in this Regulation, the distributor shall not make the product available on the market until it conforms to its accompanying declaration of performance and conformity and it complies with the other applicable requirements in this Regulation. Furthermore, where the product presents a risk, the distributor shall inform the manufacturer and the responsible competent national authorities thereof.
5. The distributor shall ensure that, while a product is under its responsibility, storage or transport conditions do not jeopardise the product’s conformity with its declared performance or its compliance with other applicable requirements in this Regulation.
6. A distributor who considers or has reason to believe that a product, which it has made available on the market, is not in conformity with its declared performance or not in compliance with other applicable requirements in this Regulation shall make sure that the necessary corrective measures to bring that product into conformity or, if appropriate, to withdraw or to recall it, are taken. Furthermore, where the product poses a risk, the distributor shall immediately inform the competent national authorities of the Member States in which it has made the product available on the market to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.
Cases in which obligations of manufacturers apply to importers and distributors
1. An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations of a manufacturer pursuant to Article 22, where:
(a)
it places a product on the market under its own name or trademark;
(b)
it modifies a product intentionally or the product is unintentionally modified in such a way that compliance with the declaration of performance and conformity, or with the requirements set out in or adopted in accordance with this Regulation may be affected;
(c)
it makes a product available on the market with a declared use that is different from the declared use attributed by the manufacturer in the process of assessment and verification;
(d)
it claims for the product characteristics deviating from the characteristics declared by the manufacturer; or
(e)
it opts to assume the role of the manufacturer.
2. Paragraph 1 shall also apply to an economic operator who places on the market:
(a)
a used product covered by a harmonised technical specification laying down provisions for used products;
(b)
a used product not covered by a harmonised technical specification with provisions for used products and not placed on the Union market before;
(c)
a remanufactured product.
3. Paragraph 1 shall not apply where the economic operator only:
(a)
adds translations of information supplied by the manufacturer;
(b)
replaces the outer packaging of a product already placed on the market, including when changing the packaging size, if the repackaging is carried out in such a way that the original condition of the product cannot be affected by it, and that any information required by this Regulation is still correctly provided.
4. An economic operator providing the activities listed in paragraph 3 shall inform thereof the manufacturer or its authorised representative, regardless of whether that economic operator owns the products or provides services. It shall carry out the repackaging in such a way that neither the original condition of the product nor its compliance with this Regulation is affected by the repackaging, and such that any information required by this Regulation is still correctly provided. The economic operator shall act with due care in relation to the obligations of this Regulation.
Obligations of fulfilment service providers
1. When contributing to the making available on the market of a product, fulfilment service providers shall act with due care in relation to the obligations of this Regulation.
2. A fulfilment service provider shall make sure that the labelling and documents provided by the manufacturer or importer are available or accompany the product, and in particular:
(a)
the CE marking and the labelling referred to in Article 22(9);
(b)
the declaration of performance and conformity;
(c)
the general product information and the instructions for use and safety information referred to in Article 22(6).
3. A fulfilment service provider shall ensure that the conditions during warehousing, packaging, addressing or dispatching do not jeopardise a product’s conformity with its declared performance or its compliance with other applicable requirements in this Regulation. Manufacturers or importers of construction products shall provide their fulfilment service providers with the detailed information necessary for ensuring the safe storage, packaging, addressing or dispatch, and the further functioning of the product.
4. Fulfilment service providers shall support product withdrawals or recalls, regardless of whether initiated by market surveillance authorities, manufacturers, authorised representatives or importers.
5. Where a fulfilment service provider considers or has reason to believe that a product is not in conformity with the declaration of performance and conformity or not in compliance with other applicable requirements in this Regulation, it shall not support the making available of the product on the market until the product conforms to the relevant declaration of performance and conformity, and it complies with the other applicable requirements in this Regulation, or until the declaration of performance and conformity is corrected. Furthermore, where the product presents a risk, the fulfilment service provider shall inform the manufacturer and the responsible competent national authority thereof.
Obligations of online marketplaces
1. An online marketplace shall:
(a)
for the purpose of complying with Article 31(1) of Regulation (EU) 2022/2065 of the European Parliament and of the Council ( 28 ) , design and organise its online interface in such a way that allows economic operators to fulfil their obligations under Article 29(2) of this Regulation;
(b)
establish a single contact point for direct communication with Member States’ competent national authorities in relation to compliance with this Regulation, which can be the same as the contact point referred to in Article 22(1) of Regulation (EU) 2023/988 or Article 11(1) of Regulation (EU) 2022/2065;
(c)
give an appropriate answer to notices related to the notification of accidents and other incidents involving products received in accordance with Article 16 of Regulation (EU) 2022/2065;
(d)
cooperate to ensure effective market surveillance measures, including by abstaining from putting in place obstacles to such measures;
(e)
inform the competent national authorities of any action taken with regard to the non-compliance or suspected non-compliance of products covered by this Regulation;
(f)
establish a regular and structured exchange of information regarding content that has been removed by online marketplaces at the request of competent national authorities;
2. As far as powers conferred by Member States in accordance to Article 14 of Regulation (EU) 2019/1020 are concerned, Member States shall confer on their market surveillance authorities the power, in respect of all products covered by this Regulation, to order an online marketplace to remove from its online interface specific illegal content referring to a non-compliant product, to disable access to it, or to display an explicit warning to end users when they access it. Such orders shall comply with Article 9 of Regulation (EU) 2022/2065.
3. An online marketplace shall take the necessary measures to receive and process in accordance with Article 9 of Regulation (EU) 2022/2065 the orders referred to in paragraph 2 of this Article.
4. This Article shall also apply to manufacturers, importers, or distributors offering products online without the involvement of an online marketplace.
Online and other distance sales
1. Products offered for sale online or through other means of distance sales shall be deemed to be made available on the market if the offer is targeted at customers in the Union. An offer for sale shall be considered to be targeted at customers in the Union if the relevant economic operator directs, by any means, its activities to a Member State. An offer shall, inter alia, be considered to be targeted at customers in the Union where:
(a)
the economic operator uses the currency of a Member State;
(b)
the economic operator has used an internet domain name registered in one of the Member States, or uses an internet domain that refers to the Union or to one of the Member States; or
(c)
the geographical areas to which dispatch is available include a Member State.
The conditions listed in the first subparagraph shall not apply if the economic operator explicitly and effectively excludes the Union market.
2. Where an economic operator makes a product available on the market online or through other means of distance selling, the offer of that product shall, where required, clearly and visibly indicate the CE marking, the information listed in Article 18(2), the label pursuant to Article 22(9) and a data carrier connected to a digital product passport in accordance with Article 22(7).
3. Any natural or legal person providing an intermediary service for the placing on the market of products shall fulfil the obligations of an economic operator pursuant to paragraph 2 in relation to the services provided.
Implementing acts regarding the obligations and rights of economic operators
Where it is necessary, to ensure the harmonised application of this Regulation, and only to the extent necessary to prevent diverging practices fragmenting the internal market for economic operators, the Commission may adopt implementing acts providing details on how economic operators are to fulfil the obligations and exercise the rights set out in this Chapter.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 90(3).
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
