Conformity, CE marking and the digital product passport

1. The CE marking shall be affixed visibly, legibly and indelibly on the toy or on an affixed label. Where the size or nature of the toy does not allow it, it shall be affixed to the packaging, if any, or on documentation accompanying the toy.

2. The CE marking shall be affixed before the toy is placed on the market.

3. The CE marking may, where applicable in accordance with Article 6, be followed by a pictogram or any other warning indicating a special risk or use.

4. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of the CE marking.

1. Before placing a toy on the market, the manufacturer shall create a digital product passport for the toy. The digital product passport shall meet the requirements laid down in this Article and Article 20.

2. The digital product passport shall:

• (a) correspond to a specific toy model;

• (b) state that compliance of the toy with the requirements set out in this Regulation and, in particular, the essential safety requirements, has been demonstrated;

• (c) contain at least the data set out in Part I of Annex VI;

• (d) be accurate, complete and up to date;

• (e) be available in the language or languages required by the Member State where the toy is made available on the market;

• (f) be accessible to consumers or other end users, market surveillance authorities, customs authorities, notified bodies, the Commission and other economic operators in accordance with the access rights set out pursuant to Article 49(1), point (d);

• (g) be available for a period of 10 years after the toy is placed on the market, including in cases of insolvency, liquidation or cessation of activity in the Union of the economic operator that created the digital product passport;

• (h) be connected through a data carrier to a persistent unique product identifier; and

• (i) fulfil the specific and technical requirements laid down pursuant to Article 49(1).

3. In addition to the data referred to in paragraph 2, the digital product passport may contain the data set out in Part II of Annex VI.

4. By creating the digital product passport, the manufacturer shall assume responsibility for the compliance of the toy with this Regulation.

5. Where the digital product passport created in accordance with this Regulation for a toy includes all the information required for the declaration of conformity in accordance with, as applicable, Regulation (EU) 2024/1689 or (EU) 2024/2847, Directive 2011/65/EU (25), 2014/30/EU (26), 2014/35/EU (27) or 2014/53/EU of the European Parliament and of the Council or Commission Delegated Regulation (EU) 2019/945 (28), the following provisions shall apply:

• (a) manufacturers and, where applicable, providers of high-risk AI systems shall be deemed to comply with the obligation to draw up an EU declaration of conformity in accordance with, as applicable, Article 16, point (g), of Regulation (EU) 2024/1689, Article 13(12) of Regulation (EU) 2024/2847, Article 7, point (c), of Directive 2011/65/EU, Article 7(2) of Directive 2014/30/EU, Article 6(2) of Directive 2014/35/EU, Article 10(3) of Directive 2014/53/EU or Article 6(2) of Delegated Regulation (EU) 2019/945;

• (b) manufacturers shall also be deemed to comply, where applicable, with the obligation set out in Article 13(20) of Regulation (EU) 2024/2847, Article 10(9) of Directive 2014/53/EU or Article 6(8) of Delegated Regulation (EU) 2019/945;

• (c) by drawing up the digital product passport, manufacturers shall assume responsibility for the compliance of the toy with the requirements laid down in the applicable Regulations or Directives;

• (d) economic operators and, where applicable, providers of high-risk AI systems shall use the digital product passport to fulfil their obligations related to the declaration of conformity in accordance with, as applicable, Article 18(1), point (e), Article 22(3), points (a) and (b), Article 23(1), point (c), Article 23(5) and Article 24(1) of Regulation (EU) 2024/1689, Article 13(13), Article 18(3), point (a), and Article 19(2) and (6) of Regulation (EU) 2024/2847, Article 7, points (c) and (d), Article 8, point (b), and Article 9, point (g), of Directive 2011/65/EU, Article 7(2) and (3), Article 8(2), point (a), and Article 9(7) of Directive 2014/30/EU, Article 6(2) and (3), Article 7(2), point (a), and Article 8(8) of Directive 2014/35/EU, Article 10(3) and (4), Article 11(2), point (a), and Article 12(8) of Directive 2014/53/EU or Article 6(3) and (4), Article 7(2), point (a), and Article 8(8) of Delegated Regulation (EU) 2019/945.

6. Where manufacturers rely on the provisions set out in paragraph 5 for the purpose of fulfilling their obligations related to the declaration of conformity, the digital product passport shall contain the information set out in point (h) of Annex VI.

7. The data carrier shall be physically present on the toy or on an affixed label. Where the size or nature of the toy does not allow it, it shall be affixed to the packaging, if any, or on documentation accompanying the toy, in accordance with the delegated act adopted pursuant to Article 49(1). It shall be clearly visible to the consumer or other end users before any purchase and to market surveillance authorities, including in cases where the toy is made available on the market through distance sales.

8. Where other Union law requires information on the toy to be available via a data carrier, a single data carrier shall be used to provide the information required pursuant to this Regulation and such other Union law.

9. Where other Union law applying to toys requires a digital product passport, a single digital product passport shall be created for toys containing the data required pursuant to this Regulation as well as any other data required for the digital product passport pursuant to such other Union law. By way of derogation from paragraph 2, point (a), where other Union law requires that the digital product passport corresponds to a batch level, the digital product passport for the purposes of this Regulation can be issued for that level.

10. Economic operators may, in addition to the data referred to in paragraphs 8 and 9, make other information accessible through the data carrier referred to in paragraph 7. Where this is the case, that information shall be clearly separated from the information required pursuant to this Regulation and, where relevant, pursuant to other Union law.

11. The manufacturer or the digital product passport service provider shall ensure that a link to the section of the Safety Gate Portal referred to in Article 34(3) of Regulation (EU) 2023/988 for the transmission of information about toys that might present a risk to the health and safety of consumers is displayed when accessing the digital product passport.

12. The economic operator placing the toy on the market shall:

• (a) provide distributors and providers of online marketplaces with a digital copy of the data carrier or the unique product identifier, as relevant, to allow them to make the data carrier or the unique product identifier accessible to potential customers where they cannot physically access the toy; and

• (b) provide the digital copy referred to in point (a) or a webpage link free of charge promptly and in any event within 5 working days of receiving a request to do so.

13. The economic operator, when placing the toy on the market, shall make available a back-up copy of the digital product passport through a digital product passport service provider.

1. In order to demonstrate that a toy complies with the essential safety requirements, manufacturers shall, before placing a toy on the market, carry out a safety assessment, including an analysis of the hazards that the toy may present, as well as an assessment of any potential exposure to such hazards.

2. The safety assessment shall in particular:

• (a) cover all the chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards and the potential exposure to such hazards;

• (b) in relation to chemical hazards, take account of the possible exposure to individual chemicals, and any known additional hazards from combined exposure to the different chemicals present in the toy, taking into account the obligations set out in Regulation (EC) No 1907/2006 and the conditions set out therein;

• (c) for toys falling within the scope of Regulation (EU) 2024/1689 or (EU) 2024/2847 or Directive 2014/53/EU, take account of the particular vulnerabilities of children in relation to the use of such toys as intended, when assessing and addressing the hazards that the toy may present; and

• (d) be updated whenever additional relevant information is available.

3. The safety assessment shall be included in the technical documentation referred to in Article 27.

1. Manufacturers shall use the conformity assessment procedures referred to in paragraph 2 or 3.

2. If the manufacturer has applied harmonised standards the references of which have been published in the Official Journal of the European Union or common specifications covering all relevant safety requirements for the toy identified in the safety assessment referred to in Article 25 the manufacturer shall use the internal production control procedure set out in Part I of Annex IV.

3. In the following cases, the manufacturer shall use the EU-type examination procedure set out in Part II of Annex IV together with the conformity-to-type procedure set out in Part III of that Annex:

• (a) where harmonised standards the references of which have been published in the Official Journal of the European Union or common specifications covering all relevant safety requirements for the toy, do not exist;

• (b) where harmonised standards or common specifications referred to in point (a) exist but the manufacturer has not applied them or has applied them only in part;

• (c) where one or more of the harmonised standards referred to in point (a) have been published with a restriction and the restriction is applicable to the toy in question;

• (d) where the manufacturer considers that the nature, design, construction or purpose of the toy necessitates third-party verification.

4. The EU-type examination certificate issued in accordance with Part II, point 6, of Annex IV shall be reviewed whenever necessary, in particular in the case of a change to the manufacturing process, the raw materials or the components of the toy, and, in any case, every five years.