Subject matter, scope and definitions

1. This Regulation applies to products that are designed or intended, whether or not exclusively, for use in play by children under 14 years of age (toys).

2. This Regulation does not apply to the products listed in Annex I.

3. The Commission is empowered to adopt implementing acts determining whether specific products or categories of products fulfil the criteria set out in paragraph 1 of this Article and can therefore be considered to be toys within the meaning of this Regulation. Those implementing acts shall be adopted in accordance with the procedure set out in Article 53(3). The date of application of such implementing acts shall not be earlier than 18 months from their entry into force, except in duly justified cases or in cases where certain categories of products are deemed not to fulfil the criteria set out in paragraph 1 of this Article, where an earlier date of application may be set.

• (1) ‘making available on the market’ means any supply of a toy for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

• (2) ‘placing on the market’ means the first making available of a toy on the Union market;

• (3) ‘manufacturer’ means any natural or legal person who manufactures a toy or has a toy designed or manufactured, and markets that toy under that person’s name or trademark;

• (4) ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on that manufacturer’s behalf in relation to specified tasks with regard to the manufacturer’s obligations under this Regulation;

• (5) ‘importer’ means any natural or legal person established within the Union who places a toy from a third country on the Union market;

• (6) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a toy available on the market;

• (7) ‘fulfilment service provider’ means fulfilment service provider as defined in Article 3, point (11), of Regulation (EU) 2019/1020;

• (8) ‘economic operator’ means the manufacturer, the authorised representative, the importer, the distributor and the fulfilment service provider;

• (9) ‘provider of an online marketplace’ means a provider of an online marketplace as defined in Article 3, point (14), of Regulation (EU) 2023/988;

• (10) ‘harmonised standard’ means a harmonised standard as defined in Article 2, point (1)(c), of Regulation (EU) No 1025/2012;

• (11) ‘Union harmonisation legislation’ means the legislative acts that are listed in Annex I to Regulation (EU) 2019/1020 and any other Union law harmonising the conditions for the marketing of products to which that Regulation applies;

• (12) ‘intended for use by’ means that a parent or supervisor shall reasonably be able to assume by virtue of the functions, dimensions and characteristics of a toy that it is intended for use by children of the specified age group;

• (13) ‘CE marking’ means a marking by which the manufacturer indicates that the toy is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing;

• (14) ‘essential safety requirements’ means the general safety requirement set out in Article 5(2) together with the particular safety requirements set out in Annex II;

• (16) ‘data carrier’ means data carrier as defined in Article 2, first paragraph, point (29), of Regulation (EU) 2024/1781;

• (17) ‘digital product passport’ means a set of data specific to a toy that contains the information set out in Annex VI and that is accessible via electronic means through a data carrier in accordance with Chapter V of this Regulation;

• (18) ‘unique product identifier’ means a unique product identifier as defined in Article 2, first paragraph, point (30) of Regulation (EU) 2024/1781;

• (19) ‘unique operator identifier’ means a unique operator identifier as defined in Article 2, first paragraph, point (31), of Regulation (EU) 2024/1781;

• (20) ‘digital product passport service provider’ means a natural or legal person that is an independent third party authorised by the economic operator required to create a digital product passport for a toy and that processes the digital product passport data for that toy for the purpose of making such data available to economic operators and other relevant actors with a right to access those data under this Regulation or other Union law;

• (21) ‘release for free circulation’ means the customs procedure laid down in Article 201 of Regulation (EU) No 952/2013;

• (22) ‘customs authorities’ means customs authorities as defined in Article 5, point (1), of Regulation (EU) No 952/2013;

• (23) ‘European Union Customs Single Window Certificates Exchange System (EU CSW-CERTEX)’ means the system established by Article 4 of Regulation (EU) 2022/2399;

• (24) ‘Safety Business Gateway’ means the web portal referred to in Article 27 of Regulation (EU) 2023/988;

• (25) ‘conformity assessment’ means the process demonstrating whether the essential safety requirements relating to a toy have been fulfilled;

• (26) ‘conformity assessment body’ means a body that performs conformity assessment activities, including calibration, testing, certification and inspection;

• (27) ‘accreditation’ means accreditation as defined in Article 2, point (10), of Regulation (EC) No 765/2008;

• (28) ‘national accreditation body’ means a national accreditation body as defined in Article 2, point (11), of Regulation (EC) No 765/2008;

• (29) ‘hazard’ means a potential source of harm;

• (30) ‘risk’ means the combination of the probability of an occurrence of a hazard and the degree of severity of the harm caused by that hazard;

• (31) ‘recall’ means any measure aimed at achieving the return of a toy that has already been made available to the end user;

• (32) ‘withdrawal’ means any measure aimed at preventing a toy in the supply chain from being made available on the market;

• (33) ‘market surveillance authority’ means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020;

• (34) ‘notifying authority’ means an authority designated by a Member State pursuant to this Regulation as responsible for the assessment and notification of conformity assessment bodies in the territory of that Member State;

• (35) ‘functional toy’ means a toy which performs and is used in the same way as a product, appliance or installation intended for use by adults, and which may be a scale model of such product, appliance or installation;

• (36) ‘aquatic toy’ means a toy that is intended for use in shallow water and which is capable of carrying or supporting a child in the water;

• (37) ‘activity toy’ means a toy for domestic use in which the support structure remains stationary while the activity is taking place and which is intended for climbing, jumping, swinging, sliding, rocking, spinning, crawling or creeping, or any combination thereof;

• (38) ‘chemical toy’ means a toy intended for the direct handling of chemical substances and mixtures;

• (39) ‘olfactory board game’ means a toy the purpose of which is to assist a child to learn to recognise different odours or flavours;

• (40) ‘cosmetic kit’ means a toy the purpose of which is to assist a child in learning to make cosmetic products such as fragrances, soaps, creams, shampoos, conditioners, bath foams and toothpastes, as well as glosses, lipsticks, nail polish and other make-up;

• (41) ‘gustative game’ means a toy the purpose of which is to allow children to make sweets or dishes through the use of food ingredients, including liquids, powders and aromas;

• (42) ‘PFAS’ means any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it).