Chapter III – Obligations of economic operators (Art. 9-21)

1. When placing their products on the market, manufacturers shall ensure that those products have been designed and manufactured in accordance with the general safety requirement laid down in Article 5.
2. Before placing their products on the market, manufacturers shall carry out an internal risk analysis and draw up technical documentation containing at least a general description of the product and its essential characteristics relevant for assessing its safety.
   Where appropriate with regard to possible risks related to the product, the technical documentation referred to in the first subparagraph shall also contain, as applicable:
   1. an analysis of the possible risks related to the product and the solutions adopted to eliminate or mitigate such risks, including the outcome of any reports related to tests conducted by the manufacturer or by another party on their behalf; and
   2. the list of any relevant European standards as referred to in Article 7(1), point (a), or the other elements referred to in Article 7(1), point (b) or Article 8, applied to meet the general safety requirement laid down in Article 5.

   Where any of the European standards, health and safety requirements or elements as referred to in Article 7(1) or Article 8 have been only partly applied, the manufacturers shall identify the parts which have been applied.

3. Manufacturers shall ensure that the technical documentation referred to in paragraph 2 is up to date. They shall keep that documentation at the disposal of the market surveillance authorities for a period of 10 years after the product has been placed on the market and make that documentation available to those authorities upon request.
4. Manufacturers shall ensure that procedures are in place for products produced in series to remain in conformity with the general safety requirement laid down in Article 5.
5. Manufacturers shall ensure that their products bear a type, batch or serial number or other element enabling the identification of the product and which is easily visible and legible for consumers, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product.
6. Manufacturers shall indicate their name, their registered trade name or registered trade mark, their postal and electronic address and, where different, the postal or electronic address of the single contact point at which they can be contacted. That information shall be placed on the product or, where that is not possible, on its packaging or in a document accompanying the product.
7. Manufacturers shall ensure that their product is accompanied by clear instructions and safety information in a language which can be easily understood by consumers, as determined by the Member State in which the product is made available on the market. That requirement shall not apply where the product can be used safely and as intended by the manufacturer without such instructions and safety information.
8. Where a manufacturer considers or has reason to believe, on the basis of the information in that manufacturer’s possession, that a product which it has placed on the market is a dangerous product, the manufacturer shall immediately:
   1. take the corrective measures necessary to bring in an effective manner the product into conformity, including a withdrawal or recall, as appropriate;
   2. inform consumers thereof, in accordance with Article 35 or 36, or both; and
   3. inform, through the Safety Business Gateway, the market surveillance authorities of the Member States in which the product has been made available on the market thereof.

   For the purposes of points (b) and (c) of the first subparagraph, the manufacturer shall give details, in particular, of the risk to the health and safety of consumers and of any corrective measure already taken, and, if available, of the quantity, by Member State, of products still circulating on the market.

9. The Commission shall ensure that the information meant to alert consumers can be provided by manufacturers through the Safety Business Gateway and is made available to consumers on the Safety Gate Portal without undue delay.
10. Manufacturers shall ensure that other economic operators, responsible persons, and providers of online marketplaces in the supply chain concerned are kept informed in a timely manner of any safety issue that they have identified.
11. Manufacturers shall make publicly available communication channels such as a telephone number, electronic address or dedicated section of their website, taking into account accessibility needs for persons with disabilities, enabling consumers to submit complaints and to inform manufacturers of any accident or safety issue they have experienced with a product.
12. Manufacturers shall investigate complaints submitted, and information received on accidents, that concern the safety of products they made available on the market and which have been alleged to be dangerous by the complainant, and shall keep an internal register of those complaints as well as of product recalls and any corrective measures taken to bring the product into conformity.
13. The internal register of complaints shall only store those personal data that are necessary for the manufacturer to investigate the complaint about an alleged dangerous product. Such data shall only be kept as long as is necessary for the purposes of the investigation and in any event no longer than five years after the data have been entered.

1. A manufacturer may, by means of a written mandate, appoint an authorised representative.
2. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The authorised representative shall provide the market surveillance authorities with a copy of that mandate upon request. The mandate shall allow the authorised representative to perform at least the following tasks:
   1. providing a market surveillance authority, upon that authority’s reasoned request, with all information and documentation necessary to demonstrate the safety of the product in an official language which can be understood by that authority;
   2. where the authorised representative considers or has reason to believe that a product in question is a dangerous product, informing the manufacturer thereof;
   3. informing the competent national authorities about any action taken to eliminate the risks posed by products covered by their mandate through a notification in the Safety Business Gateway, where the information has not been already provided by the manufacturer or upon instruction of the manufacturer;
   4. cooperating with the competent national authorities, at their request, on any action taken to eliminate in an effective manner the risks posed by products covered by their mandate.

1. Before placing a product on the market, importers shall ensure that the product complies with the general safety requirement laid down in Article 5 and that the manufacturer has complied with the requirements set out in Article 9(2), (5) and (6).
2. Where an importer considers or has reason to believe, on the basis of the information in that importer’s possession, that a product is not in conformity with Article 5 and Article 9(2), (5) and (6), the importer shall not place the product on the market until the product has been brought into conformity. Furthermore, where the product is a dangerous product, the importer shall immediately inform the manufacturer thereof and ensure that the market surveillance authorities are informed thereof through the Safety Business Gateway.
3. Importers shall indicate their name, their registered trade name or registered trade mark, their postal and electronic address and, where different, the postal or electronic address of the single contact point at which they can be contacted. That information shall be placed on the product or, where that is not possible, on its packaging or in a document accompanying the product. Importers shall ensure that any additional label does not obscure any information required by Union law on the label provided by the manufacturer.
4. Importers shall ensure that the product they imported is accompanied by clear instructions and safety information in a language which can be easily understood by consumers, as determined by the Member State in which the product is made available on the market, except where the product can be used safely and as intended by the manufacturer without such instructions and safety information.
5. Importers shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its conformity with the general safety requirement laid down in Article 5 and its conformity with Article 9(5) and (6).
6. Importers shall keep the copy of technical documentation referred to in Article 9(2) at the disposal of the market surveillance authorities for a period of 10 years after they have placed the product on the market and shall ensure that the documents referred to in Article 9(2), as applicable, can be made available to those authorities, upon request.
7. Importers shall cooperate with market surveillance authorities and the manufacturer to ensure that a product is safe.
8. Where an importer considers or has reason to believe, on the basis of the information in that importer’s possession, that a product which it has placed on the market is a dangerous product, the importer shall immediately:
   1. inform the manufacturer thereof;
   2. ensure that the corrective measures necessary to bring in an effective manner the product into conformity are taken including withdrawal or recall, as appropriate; where such measures have not been taken, the importer shall immediately take them;
   3. ensure that consumers are immediately informed thereof in accordance with Article 35 or 36, or both; and
   4. inform the market surveillance authorities of the Member States in which the product has been made available on the market thereof, through the Safety Business Gateway.

   For the purposes of points (c) and (d) of the first subparagraph the importer shall give details, in particular, of the risk to health and safety of consumers and of any corrective measure already taken, and, if available, of the quantity, by Member State, of products still circulating on the market.

9. Importers shall verify whether the communication channels referred to in Article 9(11) are publicly available to consumers, thereby allowing them to present complaints and communicate any accident or safety issue they have experienced with the product. If such channels are not available, importers shall provide for them, taking into account accessibility needs for persons with disabilities.

10. Importers shall investigate complaints submitted, and information received on accidents, that concern the safety of products they made available on the market, which the complainant has alleged to be dangerous, and file those complaints, as well as product recalls and any corrective measures taken to bring the product into conformity, in the register referred to in Article 9(12), or in their own internal register. Importers shall keep the manufacturer, distributors and, where relevant, fulfilment service providers and providers of online marketplaces informed in a timely manner of the investigation performed and of the results of the investigation.

11. The register of complaints shall only store those personal data that are necessary for the importer to investigate the complaint about an alleged dangerous product. Such data shall only be kept for as long as is necessary for the purposes of the investigation and in any event no longer than five years after the data have been entered.

1. Before making a product available on the market, distributors shall verify that the manufacturer and, where applicable, the importer have complied with the requirements set out in Article 9(5), (6) and (7) and Article 11(3) and (4), as applicable.
2. Distributors shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its conformity with the general safety requirement laid down in Article 5 and its conformity with Article 9(5), (6) and (7) and Article 11(3) and (4), as applicable.
3. Where a distributor considers or has reason to believe, on the basis of the information in that distributor’s possession, that a product is not in conformity with Article 5, Article 9(5), (6) and (7), and Article 11(3) and (4), as applicable, the distributor shall not make the product available on the market unless the product has been brought into conformity.
4. Where a distributor considers or has reason to believe, on the basis of the information in that distributor’s possession, that a product which it has made available on the market is a dangerous product or is not in conformity with Article 9(5), (6) and (7) and Article 11(3) and (4), as applicable, the distributor shall:
   1. immediately inform the manufacturer or the importer, as applicable, thereof;
   2. ensure that the corrective measures necessary to bring in an effective manner the product into conformity are taken, including withdrawal or recall, as appropriate; and
   3. ensure that the market surveillance authorities of the Member States in which the product has been made available on the market are immediately informed thereof through the Safety Business Gateway.

   For the purposes of points (b) and (c) of the first subparagraph the distributor shall give appropriate details available to it of the risk to health and safety of consumers, of the number of products involved and of any corrective measure already taken.

1. A natural or legal person shall be deemed to be a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer set out in Article 9 where that natural or legal person places a product on the market under the natural or legal person’s name or trademark.
2. A natural or legal person, other than the manufacturer, that substantially modifies the product, shall be deemed to be a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer set out in Article 9 for the part of the product affected by the modification or for the entire product if the substantial modification has an impact on its safety.
3. A modification of a product, by physical or digital means, shall be deemed to be substantial where it has an impact on the safety of the product and the following criteria are met:
   1. the modification changes the product in a manner which was not foreseen in the initial risk assessment of the product;
   2. the nature of the hazard has changed, a new hazard has been created or the level of risk has increased because of the modification; and
   3. the modifications have not been made by the consumers themselves or on their behalf for their own use.

1. Economic operators shall cooperate with market surveillance authorities regarding actions which could eliminate or mitigate risks that are presented by the products which they made available on the market.
2. On request by a market surveillance authority, the economic operator shall provide all necessary information, in particular:
   1. a full description of the risk presented by the product, related complaints and known accidents; and
   2. a description of any corrective measure taken to address the risk.
3. On request, the economic operators shall also identify and communicate the following relevant traceability information for the product:
   1. any economic operator who has supplied them with the product, or with a part, a component or any software embedded into the product; and
   2. any economic operator to whom they have supplied the product.
4. Economic operators shall be able to present the information referred to in paragraph 2 for a period of 10 years after they have been supplied with the product or after they have supplied the product, as applicable.
5. Economic operators shall be able to present the information referred to in paragraph 3 for a period of six years after they have been supplied with the product, or with a part, a component or any software embedded into the product, or after they have supplied the product, as applicable.
6. Market surveillance authorities may request the economic operators to submit regular progress reports and may decide whether or when the corrective measure can be considered completed.

1. A product covered by this Regulation shall not be placed on the market unless there is an economic operator established in the Union who is responsible for the tasks set out in Article 4(3) of Regulation (EU) 2019/1020 in respect to that product. Article 4(2) and (3) of that Regulation shall apply to products covered by this Regulation. For the purposes of this Regulation, references to ‘Union harmonisation legislation’ and ‘applicable Union harmonisation legislation’ in Article 4(3) of that Regulation shall be read as ‘this Regulation’.
2. Without prejudice to any obligations of economic operators under this Regulation, in addition to the tasks referred to in Article 4(3) of Regulation (EU) 2019/1020, and to ensure the safety of the product it is responsible for, where appropriate with regard to the possible risks related to a product, the economic operator referred to in paragraph 1 of this Article shall regularly check:
   1. that the product complies with the technical documentation referred to in Article 9(2) of this Regulation;
   2. that the product complies with the requirements provided for in Article 9(5), (6) and (7) of this Regulation.

   The economic operator referred to in paragraph 1 of this Article shall, upon request by the market surveillance authorities, provide documented evidence of the checks performed.

3. The name, registered trade name or registered trade mark, and contact details, including the postal and electronic address, of the economic operator referred to in paragraph 1 shall be indicated on the product or on its packaging, the parcel or an accompanying document.

1. The Commission shall provide economic operators, free of charge, with general information with respect to this Regulation.
2. Member States shall provide economic operators, at their request and free of charge, with specific information with respect to the implementation of this Regulation at national level and national rules on product safety applicable to products covered by this Regulation. For that purpose, Article 9(1) and (4) of Regulation (EU) 2019/515 of the European Parliament and of the Council⁽²⁹⁾ shall apply.
   The Commission shall adopt specific guidelines for economic operators, with particular regard to the needs of those that qualify as SMEs, including micro-enterprises, on how to fulfil the obligations laid down in this Regulation.

1. For certain products, categories or groups of products which are likely to present a serious risk to the health and safety of consumers, based on accidents registered in the Safety Business Gateway, the Safety Gate statistics, the results of the joint activities on product safety and other relevant indicators or evidence, and after consulting the Consumer Safety Network, relevant expert groups and relevant stakeholders, the Commission may set up a system of traceability to which economic operators who place and make available those products on the market shall adhere.
2. The system of traceability shall consist of the collection and storage of data, including by electronic means, enabling the identification of the product, its components or of the economic operators involved in its supply chain, as well as in modalities to display and to access those data, including placement of a data carrier on the product, its packaging or accompanying documents.
3. The Commission is empowered to adopt delegated acts in accordance with Article 45 to supplement this Regulation by:
   1. determining the products, categories or groups of products or components likely to present a serious risk to the health and safety of consumers as referred to in paragraph 1; the Commission shall state in the delegated acts concerned whether it has used the risk analysis methodology provided for in Commission Implementing Decision (EU) 2019/417⁽³⁰⁾ or, if that methodology is not appropriate for the product concerned, it shall give a detailed description of the methodology used;
   2. specifying the type of data which economic operators are to collect and store by means of the system of traceability referred to in paragraph 2;
   3. specifying the modalities to display and to access data, including placement of a data carrier on the product, its packaging or accompanying documents as referred to in paragraph 2;
   4. specifying the actors that shall have access to the data as referred to in point (b) and to what data they shall have access, including consumers, economic operators, providers of online marketplaces, competent national authorities, the Commission, and public interest organisations, or any organisation acting on their behalf.
4. Market surveillance authorities, consumers, economic operators and other relevant actors shall have access free of charge to the data referred to in paragraph 3 based on their respective access rights set out in the applicable delegated act adopted pursuant to paragraph 3, point (d).
5. When adopting the measures referred to in paragraph 3, the Commission shall take into account:
   1. the cost-effectiveness of the measures, including the impact of the measures on businesses, in particular SMEs;
   2. an adequate timeframe to allow economic operators to prepare for those measures; and
   3. the compatibility and interoperability with other product traceability systems already set up at Union or at international level.

^{(30) Commission Implementing Decision (EU) 2019/417 of 8 November 2018 laying down guidelines for the management of the European Union Rapid Information System ‘RAPEX’ established under Article 12 of Directive 2001/95/EC on general product safety and its notification system (OJ L 73, 15.3.2019, p. 121).}

Where economic operators make products available on the market online or through other means of distance sales, the offer of those products shall clearly and visibly indicate at least the following information:

1. 1. name, registered trade name or registered trade mark of the manufacturer, as well as the postal and electronic address at which they can be contacted;
   2. where the manufacturer is not established in the Union, the name, postal and electronic address of the responsible person within the meaning of Article 16(1) of this Regulation or Article 4(1) of Regulation (EU) 2019/1020;
   3. information allowing the identification of the product, including a picture of it, its type and any other product identifier; and
   4. any warning or safety information to be affixed to the product or to the packaging or included in an accompanying document in accordance with this Regulation or the applicable Union harmonisation legislation in a language which can be easily understood by consumers, as determined by the Member State in which the product is made available on the market.

1. The manufacturer shall ensure that, through the Safety Business Gateway, an accident caused by a product placed or made available on the market is notified, without undue delay from the moment it knows about the accident, to the competent authorities of the Member State where the accident has occurred. The notification shall include the type and identification number of the product as well as the circumstances of the accident, if known. The manufacturer shall notify, upon request, to the competent authorities any other relevant information.
2. For the purpose of paragraph 1, the manufacturer shall notify the competent authorities of the occurrences associated with the use of a product that resulted in an individual’s death or in serious adverse effects on that individual’s health and safety, permanent or temporary, including injuries, other damage to the body, illnesses and chronic health effects.
3. The importers and the distributors which have knowledge of an accident caused by a product that they placed or made available on the market shall without undue delay inform the manufacturer thereof. The manufacturer shall make the notification in accordance with paragraph 1 or instruct the importer or one of the distributors to make the notification.
4. Where the manufacturer of the product is not established in the Union, the responsible person within the meaning of Article 16(1) of this Regulation or Article 4(1) of Regulation (EU) 2019/1020 who has knowledge of an accident shall ensure that the notification is made.

Without prejudice to Article 9(5), (6) and (7), Article 11(3) and Article 16(3), and the relevant provisions of Union harmonisation legislation, economic operators may additionally make the information referred to in those provisions available in a digital format by means of electronic technical solutions clearly visible on the product or, where that is not possible, on its packaging or in a document accompanying the product. That information shall be in a language which can be easily understood by consumers, as determined by the Member State in which the product is made available on the market, including in accessible formats for persons with disabilities.