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Subject matter
This Regulation lays down rules on the safety of toys in order to ensure a high level of protection of the health and safety of children and other persons, taking due account of the precautionary principle, and rules on the free movement of toys in the Union.
Scope
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). For the purposes of this Regulation, a product shall be considered to be intended for use in play by children under 14 years of age where a parent or supervisor can reasonably assume, by virtue of the functions, dimensions and characteristics of that product, that it is intended for use in play by children of a relevant age group. 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.
Definitions
For the purposes of this Regulation, the following definitions apply: (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; (15) ‘toy model’ means a group of toys that meet the following conditions: (a) they are under the responsibility of the same manufacturer; (b) they have uniform design and technical characteristics; (c) they are manufactured using uniform materials and manufacturing processes; and (d) they are defined by a type number or other element allowing them to be identified as a group; (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 (CF 3 -) or methylene (-CF 2 -) carbon atom (without any H/Cl/Br/I attached to it).
Free movement
1. Member States shall not prohibit, restrict or impede, for reasons relating to health and safety or other aspects covered by this Regulation, the making available on the market of toys which comply with this Regulation. 2. At trade fairs, exhibitions and demonstrations or similar events, Member States shall not prevent the display of a toy which does not comply with this Regulation, provided that a visible sign clearly indicates that the toy does not comply with this Regulation and will not be made available on the market until it has been brought into conformity. During fairs, exhibitions and demonstrations, adequate measures shall be taken by economic operators to ensure the protection of persons.
Essential safety requirements
1. Toys shall be placed on the market only if they comply with the essential safety requirements, which consist of the safety requirement set out in paragraph 2 (the ‘general safety requirement’) and the safety requirements set out in Annex II (the ‘particular safety requirements’). 2. Toys shall not present a risk to the safety or health of users or other persons, when they are used as intended or in a foreseeable way, bearing in mind the behaviour of children. When assessing the risk referred to in the first subparagraph, the ability of the users and, where appropriate, their supervisors shall be taken into account. Where a toy is intended for use by children under 36 months or by another specified age group, the ability of users in that age group shall be taken into account. 3. Toys placed on the market shall comply with the essential safety requirements during their foreseeable period of use.
Warnings
1. Where necessary to ensure their safe use, toys shall bear warnings specifying appropriate user limitations. The user limitations shall include at least the minimum age of the user and, where appropriate, the required abilities of the user, the maximum weight or minimum weight of the user and the need to ensure that the toy is used only under adult supervision. 2. The categories of toys listed in Annex III shall bear warnings in accordance with the rules for each category set out in that Annex. Toys shall not bear one or more of the warnings set out in Annex III where such warnings conflict with the intended use or reasonably foreseeable use of the toy, as determined by virtue of its function, dimensions and characteristics. 3. The manufacturer shall mark warnings in a clearly visible, easily legible and understandable and accurate manner on the toy, on an affixed label or on the packaging and, if appropriate, on the instructions for use which accompany the toy. Toys which are sold without packaging shall have appropriate warnings affixed to them if the surface of the toy allows. If this is not possible, the warnings shall be placed on the label. Warnings shall comply with the visibility and legibility criteria set out in Annex III. Warnings as set out in paragraphs 1 and 2 shall be clearly visible to the consumer before purchase, including in cases where the purchase is made through distance sales. 4. Labels and instructions for use shall draw the attention of children or their supervisors to the inherent hazards and risks to the health and safety of children, considering the age group of children for which the toys are intended, and to the ways of avoiding such hazards and risks.
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