Obligations of manufacturers
1. When placing toys on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential safety requirements.
2. Before placing toys on the market, manufacturers shall draw up the required technical documentation in accordance with Article 27 and carry out the applicable conformity assessment procedure in accordance with Article 26 or have it carried out.
Where compliance of a toy with the applicable requirements laid down in this Regulation has been demonstrated by the procedure referred to in the first subparagraph, manufacturers shall, before the toy is placed on the market:
(a)
create a digital product passport for the toy in accordance with Article 19;
(b)
affix the data carrier in accordance with Article 19(7);
(c)
affix the CE marking in accordance with Article 18(1); and
(d)
upload the unique product identifier and the unique operator identifier of the toy, as well as any other additional information determined by a delegated act adopted in accordance with Article 49(3), to the digital product passport registry referred to in Article 22(1).
3. Manufacturers shall ensure that the technical documentation referred to in paragraph 2 is up to date. Furthermore, manufacturers shall keep the technical documentation and the digital product passport for a period of 10 years after the toy covered by that documentation and digital product passport has been placed on the market.
4. Manufacturers shall ensure that procedures are in place for toys that are part of a series production to remain in conformity with this Regulation. Changes in the design or characteristics of toys, and changes in the harmonised standards referred to in Article 15 or the common specifications referred to in Article 16 by reference to which conformity of a toy is declared or by application of which its conformity is verified, shall be adequately taken into account.
When deemed appropriate with regard to the risks presented by a toy, manufacturers shall, for the protection of the health and safety of consumers or other end users, carry out sample testing of marketed toys.
5. Manufacturers shall ensure that toys bear a type, batch, serial or model number or other element allowing their identification, or, where the size or nature of the toy does not allow it, that the required information is provided on the packaging or in a document accompanying the toy.
6. Manufacturers shall indicate their name, registered trade name or registered trade mark and the postal and electronic address at which they can be contacted on the toy or, where that is not feasible, on its packaging, in a document accompanying the toy or in the digital product passport. Manufacturers shall indicate a single point at which they can be contacted.
7. Manufacturers shall ensure that the toy is accompanied by instructions for use and safety information in a language or languages easily understood by consumers and other end users, as determined by the Member State concerned. Such instructions and information shall be clear, understandable and legible, including for persons with disabilities if feasible.
8. Manufacturers shall ensure that the toy bears warnings in accordance with Article 6 in a language or languages easily understood by consumers and other end users, as determined by the Member State concerned.
9. Where manufacturers consider, or have reason to believe, that a toy that they have placed on the market is not in conformity with this Regulation, they shall immediately take the corrective measures necessary to bring that toy into conformity, to withdraw it or to recall it, as appropriate.
Furthermore, where manufacturers consider, or have reason to believe, that a toy presents a risk, they shall immediately inform:
(a)
the market surveillance authorities of the Member States in which they have made the toy available, through the Safety Business Gateway, giving details, in particular, of any non-compliance and of any corrective measures taken; and
(b)
the consumers or other end users, in accordance with Article 35 or 36 of Regulation (EU) 2023/988 or both.
10. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the toy, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, as regards any action taken to eliminate the risks posed by toys which they have placed on the market.
11. Manufacturers shall ensure that other economic operators, the economic operator referred to in Article 4(1) of Regulation (EU) 2019/1020, and providers of online marketplaces, in the supply chain concerned, are kept informed in a timely manner of any non-compliance that the manufacturers have identified.
Manufacturers shall ensure that the fulfilment service providers are provided with the detailed information necessary for ensuring the safe storage, packaging, addressing or dispatch of toys.
12. Manufacturers shall make communication channels publicly available, such as a telephone number, an electronic address or a dedicated section of their website, in order to allow consumers or other end users to submit complaints concerning the safety of toys and to inform the manufacturers of any accident or safety issue they have experienced with such toys. In doing so, the manufacturers shall take into account the accessibility needs of persons with disabilities.
13. Manufacturers shall investigate complaints and information referred to in paragraph 12 and shall keep an internal register of those complaints and that information, as well as of recalls and any other corrective measures taken to bring the toys into conformity with this Regulation.
14. The internal register referred to in paragraph 13 shall contain only personal data that are necessary for the manufacturer to investigate the complaint or the information referred to in paragraph 12. Such data shall be kept only as long as is necessary for the purposes of the investigation and, in any event, no longer than 5 years after the data have been entered into the internal register.
Authorised representatives
1. A manufacturer may appoint an authorised representative by written mandate.
2. The obligations laid down in Article 7(1), and the obligation to draw up technical documentation referred to in Article 7(2), shall not form part of the authorised representative’s mandate.
3. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer and shall provide a copy of the mandate to the market surveillance authorities upon their request. The mandate shall allow the authorised representative to do at least the following:
(a)
keep the technical documentation at the disposal of competent national authorities and ensure that the digital product passport is available, in accordance with Article 19(2), for a period of 10 years after the toy covered by that documentation and that digital product passport has been placed on the market;
(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 toy in a language which can be easily understood by that authority;
(c)
cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by toys covered by the mandate; and
(d)
inform the competent national authorities about any action taken to eliminate the risks posed by toys covered by their mandate through the Safety Business Gateway, where the information has not already been provided by the manufacturer.
4. Where a manufacturer not established in the Union appoints an authorised representative as referred to in paragraph 1 of this Article, the written mandate shall include the tasks set out in Article 4(3) of Regulation (EU) 2019/1020.
5. Where there is reason to believe that a toy is non-compliant or presents a risk, authorised representatives shall immediately inform the market surveillance authorities thereof.
Obligations of importers
1. Importers shall place on the market only toys complying with this Regulation.
2. Before placing toys on the market, importers shall ensure the following:
(a)
the manufacturer has carried out the appropriate conformity assessment procedure and drawn up the technical documentation referred to in Article 7(2);
(b)
the toy is accompanied by instructions for use and safety information in accordance with Article 7(7) and bears warnings in accordance with Article 6 in a language or languages which can be easily understood by consumers or other end users, as determined by the Member State concerned;
(c)
the manufacturer has created a digital product passport for the toy in accordance with Article 7(2), second subparagraph, point (a);
(d)
the data carrier is affixed in accordance with Article 19(7);
(e)
the relevant information from the digital product passport has been uploaded in the digital product passport registry in accordance with Article 22(1);
(f)
the CE marking is affixed in accordance with Article 18(1); and
(g)
the manufacturer has complied with the requirements set out in Article 7(5) and (6).
3. Where importers consider, or have reason to believe, that a toy is not in conformity with this Regulation, they shall inform the manufacturer and refrain from placing the toy on the market until it has been brought into conformity.
Furthermore, where importers consider, or have reason to believe, that a toy presents a risk, they shall:
(a)
immediately inform the manufacturer thereof; and
(b)
ensure that the market surveillance authorities are immediately informed through the Safety Business Gateway.
4. Importers shall indicate their name, registered trade name or registered trade mark and the postal and electronic address at which they can be contacted on the toy or, where that is not feasible, on its packaging, in a document accompanying the toy or in the digital product passport.
5. Importers shall ensure that, while a toy is under their responsibility, storage or transport conditions do not jeopardise its compliance with the essential safety requirements.
6. When deemed appropriate with regard to the risks presented by a toy, importers shall, for the protection of the health and safety of consumers or other end users, carry out sample testing of marketed toys.
7. Where importers consider, or have reason to believe, that a toy that they have placed on the market is not in conformity with this Regulation, they shall immediately take the corrective measures necessary to bring that toy into conformity, to withdraw it or to recall it, as appropriate.
Furthermore, where importers consider, or have reason to believe, that a toy that they have placed on the market presents a risk, they shall:
(a)
immediately inform the manufacturer thereof;
(b)
ensure that consumers or other end users are immediately informed thereof in accordance with Article 35 or 36 of Regulation (EU) 2023/988 or both; and
(c)
immediately inform the market surveillance authorities through the Safety Business Gateway, giving details, in particular, of the non-compliance and of any corrective measures taken.
8. Importers shall, for a period of 10 years after the toy has been placed on the market, keep the unique product identifier of the toy at the disposal of the market surveillance authorities and ensure that the technical documentation referred to in Article 27 can be made available to those authorities, upon request.
9. Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the toy in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, as regards any action taken to eliminate the risks posed by toys which they have placed on the market.
10. Importers shall verify whether the manufacturer has made communication channels as referred to in Article 7(12) publicly available to consumers or other end users, in order to allow them to submit complaints concerning the safety of toys and provide information on any accident or safety issue they have experienced with the toy. If communication channels are not available, importers shall provide for them, taking into account accessibility needs for persons with disabilities.
11. Importers shall investigate complaints and information as referred to in paragraph 10 of this Article that they have received via a communication channel made available by the manufacturer, or via a communication channel made available by the importers themselves, and that concern the toys that they have made available on the market. Importers shall file such complaints, as well as recalls and any other corrective measures taken to bring the toys into conformity with this Regulation, in the register referred to in Article 7(13), or in their own internal register.
Importers shall keep the manufacturer, distributors and, where relevant, providers of online marketplaces informed in a timely manner of the investigation performed and of the results of the investigation.
12. The internal register referred to in paragraph 11, first subparagraph, shall contain only personal data that are necessary for the importer to investigate the complaint or the information referred to in paragraph 10. Such data shall be kept only as long as is necessary for the purposes of the investigation and, in any event, no longer than 5 years after the data have been entered into the internal register.
Obligations of distributors
1. When making a toy available on the market, distributors shall act with due care in relation to the requirements of this Regulation.
2. Before making a toy available on the market, distributors shall verify that the following conditions have been met:
(a)
the toy is accompanied by instructions for use and safety information in accordance with Article 7(7) and bears warnings in accordance with Article 6 in a language or languages which can be easily understood by consumers or other end users as determined by the Member State in which the toy is to be made available on the market;
(b)
the data carrier is affixed in accordance with Article 19(7);
(c)
the CE marking is affixed in accordance with Article 18(1); and
(d)
the manufacturer and the importer have complied with the requirements set out in Article 7(2), second subparagraph, and Article 7(5), (6) and (12) and in Article 9(4), respectively.
3. Where distributors consider, or have reason to believe, that a toy is not in conformity with this Regulation, they shall inform the manufacturer or importer and refrain from making the toy available on the market until it has been brought into conformity.
Furthermore, where distributors consider, or have reason to believe, that a toy presents a risk, they shall:
(a)
immediately inform the manufacturer or the importer, as applicable, thereof; and
(b)
ensure that the market surveillance authorities are immediately informed through the Safety Business Gateway;
4. Distributors shall ensure that, while a toy is under their responsibility, storage or transport conditions do not jeopardise its compliance with the essential safety requirement.
5. Where distributors consider, or have reason to believe, that a toy which they have made available on the market is not in conformity with this Regulation, they shall ensure that the corrective measures necessary to bring that toy into conformity, to withdraw it or to recall it, as appropriate, are immediately taken.
Furthermore, where distributors consider, or have reason to believe, that a toy that they have made available on the market presents a risk, they shall immediately inform:
(a)
the market surveillance authorities of the Member States in which they made the toy available, through the Safety Business Gateway, giving details, in particular, of the non-compliance and of any corrective measures taken; and
(b)
consumers or other end users, in accordance with Article 35 or 36 of Regulation (EU) 2023/988 or both.
6. Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the toy, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, as regards any action taken to eliminate the risks posed by toys which they have made available on the market.
Obligations of fulfilment service providers
1. When contributing to the making available on the market of a toy, fulfilment service providers shall act with due care in relation to the requirements of this Regulation.
2. Fulfilment service providers shall ensure that the conditions during warehousing, packaging, addressing or dispatching do not jeopardise the toy’s conformity with the essential safety requirements.
3. Fulfilment service providers shall cooperate as regards product withdrawals or recalls, regardless of whether initiated by authorities, the manufacturer, the authorised representative or the importer.
4. Where fulfilment service providers consider or have reason to believe, on the basis of the information provided by authorities or economic operators, that the toy is not in conformity with this Regulation, they shall not support the making available of the toy on the market until it has been brought into conformity.
Cases in which obligations of manufacturers apply to other persons
1. A natural or legal person shall be considered to be a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer set out in Article 7, where such a natural or legal person places a toy on the market under that person’s name or trademark or carries out a substantial modification on a toy already placed on the market in such a way that compliance with the applicable requirements of this Regulation may be affected and makes it available on the market.
2. A modification of a toy, by physical or digital means after a toy has been placed on the market, shall be deemed to be substantial where it has not been foreseen or planned by the manufacturer and where it affects the safety of that toy, by creating a new hazard or by increasing an existing risk.
3. A consumer or other end user who carries out a substantial modification to his or her toy shall not be considered to be a manufacturer for the purposes of this Regulation and shall not be subject to the obligations of the manufacturer set out in Article 7.
Identification of economic operators
1. Economic operators shall, on request, identify the following to the market surveillance authorities:
(a)
any economic operator who has supplied them with a toy;
(b)
any economic operator to whom they have supplied a toy.
2. Economic operators shall be able to present the information referred to in the paragraph 1 for a period of 10 years after the toy has been placed on the market, in the case of the manufacturer, and for a period of 10 years after they have been supplied with the toy, in the case of other economic operators.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
