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Changes between two versions

What changed between the adopted text of 13 Mar 2024 and the adopted text of 25 Nov 2025

From · adopted text· 13 Mar 2024

TA-9-2024-0144

Safety of toys and repealing Directive 2009/48/EC

To · adopted text· 25 Nov 2025

TA-10-2025-0279

Safety of toys and repealing Directive 2009/48/EC

These two texts have too little in common to compare paragraph by paragraph: they are different documents rather than versions of one (for example one group’s motion and the joint text that was adopted).

+13 added · −888 removed · 5 changed paragraphs, packaging included.

Part 4 of 16: Paragraphs 181–240

Removed:(36) ‘substance of concern’ means substance of concern as defined in Article 2, point (28), of Regulation (EU) …/… [on Ecodesign Requirements for Sustainable Products]. [Am. 59]

Removed:Article 4 Free movement

Removed: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. [Am. 60]

Removed: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 available on the market until it has been brought into conformity.

Removed:During fairs, exhibitions and demonstrations, adequate measures shall be taken by economic operators to ensure the protection of persons.

Removed:Article 5 ProductEssential safety requirements [Am. 61]

Removed:1. Toys shall only be placed on the market if they comply with the essential safety requirements which include 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’).

Removed:2. Toys shall not present a risk to the safety or health of users or third parties, including the psychological and mental health, well-being and cognitive development of children, when they are used as intended or in a foreseeable way, bearing in mind the behaviour of children. [Am. 62]

Removed:When assessing the risk referred to in the first subparagraph, a manufacturer of digitally connected toys shall, where appropriate, according to reasonable best efforts, also take into account any risk posed to mental health, as well as the cognitive development, of children, that may arise when such toys are used in accordance with their intended use. [Am. 63]

Removed:A manufacturer shall apply the second subparagraph in a manner that is proportionate to its capability in relation to adequately assessing those risks. [Am. 64]

Removed: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 groups, the ability of users in that specific age group shall be taken into account.

Removed:3. Toys placed on the market shall comply with the essential safety requirements during their foreseeable period of use.

Removed:Article 6 Warnings

Removed:1. Where necessary to ensure their safe use and the health of children, toys shall bear a general warning specifying appropriate user limitations. The user limitations shall include at least the minimum or maximum 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. [Am. 65]

Removed:2. The following categories of toys shall bear warnings in accordance with the rules for each category set out in Annex III: shall bear warnings. [Am. 66]

Removed:(a) toys not intended for use by children under 36 months; [Am. 67]

Removed:(b) activity toys; [Am. 68]

Removed:(c) functional toys; [Am. 69]

Removed:(d) chemical toys; [Am. 70]

Removed:(e) skater, roller skates, inline skates, skateboards, scooters and toy bicycles; [Am. 71]

Removed:(f) aquatic toys; [Am. 72]

Removed:(g) toys in food; [Am. 73]

Removed:(h) imitations of protective masks and helmets; [Am. 74]

Removed:(i) toys intended to be strung across a cradle, cot or perambulator by means of strings, cords, elastics or straps; [Am. 75]

Removed:(j) packaging for fragrances in olfactory board games, cosmetic kits and gustative games. [Am. 76]

Removed:Toys shall not bear one or more of the warnings set out in Annex III where such warnings conflict with the intended use of the toy, as determined by virtue of its function, dimension and characteristics.

Removed: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. Small 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. The manufacturer may add a QR-code which provides a link to the instructions in a digital format, but shall always mark warnings on the toy, on an affixed label or on the packaging. [Am. 77]

Removed:Warnings which determine the decision to purchase the toy shall be clearly visible to the consumer before the purchase, including in cases where the purchase is made through distance and online sales. Warnings shall be of sufficient size to ensure theirthat they are also immediately visible and legible online. The Commission shall adopt implementing acts determining criteria related to the visibility and legibility of warnings, including for online sales, 12 months after the date of entry into force of this Regulation. [Am. 78]

Removed: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 involved in usingconsidering the age group of children for which the toys are intended, and to the ways of avoiding such hazards and risks. [Am. 79]

Removed:CHAPTER II OBLIGATIONS OF ECONOMIC OPERATORS

Removed:Article 7 Obligations of manufacturers

Removed:1. When placing toys on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential safety requirements.

Removed:2. Before placing toys on the market, manufacturers shall draw up the required technical documentation in accordance with Article 23 and carry out the applicable conformity assessment procedure in accordance with Article 22 or have it carried out.

Removed: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:

Removed:(a) create a digital product passport for the toy in accordance with Article 17; [Am. 80]

Removed:(b) affix the data carrier to the toy or to a label attached to the toy, in accordance with Article 17(5); [Am. 81]

Removed:(c) affix the CE marking in accordance with Article 16(1);

Removed:(d) upload the unique product identifier and the unique operator identifier of the toy in the digital product passport registry referred to in Article 19(1), as well as any other additional information determined by a delegated act adopted in accordance with Article 46(2). [Am. 82]

Removed:3. Manufacturers shall keep the technical documentation up to date and the digital product passport for a period of 10 years after the last item of the toy modeltoy covered by that documentation and digital product passport has been placed on the market. [Am. 83]

Removed: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 13 or the common specifications referred to in Article 14 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.

Removed:When manufacturers,deemed appropriate with regard to the risks presented by a toy, consider it necessary for the protection of health and safety of consumers, manufacturers shall, carry out sample testing of marketed toys. [Am. 84]

Removed: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.

Removed:6. Manufacturers shall indicate their name, registered trade name or registered trade mark and the postal andor electronic address at which they can be contacted on the toy or, where that is not possiblefeasible, on its packaging or in a document accompanying the toy or in the digital product passport. Manufacturers shall indicate a single point at which they can be contacted. [Am. 85]

Removed: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 including persons with disabilities if feasible, as determined by the Member State concerned. Such instructions and information shall be clear, understandable and legible. [Am. 86]

Removed:8. Where manufacturers consider, or have reason to believe, on the basis of the information in that manufacturer´s possession, that a toy which 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, withdraw it or recall it, as appropriate. [Am. 87]

Removed:Where manufacturers consider, or have reason to believe, on the basis of the information in that manufacturer´s possession, that a toy presents a risk, they shall immediately provide information thereof to: [Am. 88]

Removed:(a) the market surveillance authorities of the Member States in which they have made the toy available, via the Safety Business Gateway referred to in Article 26 of Regulation (EU) 2023/988, giving details, in particular, of any non-compliance and of any corrective measures taken and if available, of the quantity, by Member State, of the toys still circulating on the market; and [Am. 89]

Removed:(b) the consumers or other end-users, in accordance with Article 35 or 36 of Regulation (EU) 2023/988, or both.

Removed:9. 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.

Removed:10. 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-conformity that the manufacturers have identified. [Am. 90]

Removed:11. Manufacturers shall make publicly available communication channels such as a telephone number, an electronic address, a dedicated section of their website or another communication channel, allowing consumers or other end-users to filesubmit 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 for persons with disabilities. The communication channel shall include 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 may present a risk to the health and safety of consumers. [Am. 91]

Removed:12. Manufacturers shall investigate complaints and information referred to in paragraph 11 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.

Removed:13. The internal register referred to in paragraph 12 shall only contain personal data that are necessary for the manufacturer to investigate the complaint or the information referred to in paragraph 11. Such data shall only be kept as long as is necessary for the purpose of the investigation and, in any event, no longer than 5 years after the data have been entered in the register.

Removed:Article 8 Authorised representatives

Removed:1. A manufacturer may appoint an authorised representative by written mandate. When manufacturers terminate the mandate of their authorised representative, they shall inform the market surveillance authority. A manufacturer established in the Union may also appoint an authorised representative. [Am. 92]

Removed: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.

Removed: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:

Removed:(a) keep the technical documentation at the disposal of national surveillance authorities and ensure that the digital product passport is available, in accordance with Article 17(2), for a period of 10 years after the last item of the toy modeltoy covered by those documents has been placed on the market; [Am. 93]

Removed:(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 an official language, which can be understood, by that authority; [Am. 94]

Removed:(c) cooperate with the competent national authorities, at their request, on any action taken to eliminate in an effective manner the risks posed by toys covered by the written mandate.; [Am. 95]