The final draft version of the text, which will become the new EU Toy Safety Regulation, was approved by the Council Committee of Permanent Representatives (COREPER) on 11th June 2025. This text represents the final compromise aimed at reaching an agreement on the Proposal for a Regulation on the safety of toys between the European Parliament and the Council. It will replace eventually repeal Directive 2009/48/EC.
This new Regulation has been designed to bring the current Toy Safety Directive (2009/48/EC) up to date with developments within the marketplace such as digitally connected toys, etc. and to close loopholes allowing unsafe toys to be sold via online marketplaces. The implementation of this Regulation is intended to contribute to the strengthening of the internal market and improve its functioning while providing for a high level of consumer protection.
Effective Date: Once adopted by the Parliament, the new Regulation will enter into force on the twentieth day following its publication in the Official Journal of the European Union. The current Toy Safety Directive 2009/48/EC will be repealed 54 months after the date of entry into force of this Regulation.It is expected that the new Toy Safety Regulation be published in the autumn.
Key Updates
Safety Assessments
- The manufacturer’s safety assessment should take into account the health risk posed by digitally connected toys, where appropriate, including any risk posed to mental health.
- Furthermore, when performing their safety assessment in relation to chemical hazards, manufacturers must 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. The possible non-intended presence of restricted substances must also be considered.
Toys not clearly designed to emit sound
- Toys that are not clearly designed to emit sound but do emit a reproduceable sound when a child activates a mechanism such as a trigger on a toy gun, should be designed so as to protect children from the risk of impaired hearing.
Safety warnings
- Where warnings are applied, the word “warning” can be replaced by a generic
warning symbol which must be a minimum of 10mm high. - A minimum font size for warnings will be introduced; a minimum x-height of 1.2mm for most toys and a minimum x-height of 0.9mm for small toys (i.e. those where the largest surface area of the container or packaging is less than 80cm²).
Digital product passport (DPP)
- Instead of creating an EU declaration of conformity, manufacturers will be required to create a digital product passport (DPP), which must correspond to a specific toy model.
- The DPP must contain various information relating to the toy and must be available for a period of 10 years after the toy is placed on the market, even in cases of insolvency, liquidation or a cessation of activity in the EU.
- Where other Union law applying to toys requires a digital product passport, a single DPP should be created to cover the requirements of all relevant pieces of legislation.
- A back-up copy of the digital product passport shall be available through a digital product passport service provider.
- By completing the DPP (and applying the CE marking), the manufacturer is making a declaration that their toy is in compliance with the requirements of the Regulation and takes full responsibility for the toy.
Digital product passport registry
- The responsible economic operator, before placing a toy on the market, will have to upload, in the registry established under Article 13 of the Ecodesign for Sustainable Products Regulation (the ‘registry’), the unique product identifier and unique operator identifier for the toy and in some cases the toy’s commodity code.
Data carrier
- In order to facilitate checks on toys by market surveillance authorities and to allow the actors in the supply chain and consumers to access information on the toy and on communication channels, the information on the digital product passport should be provided digitally and in a directly accessible manner, through a data carrier affixed to the toy, its packaging or the accompanying documentation.
- Depending on access rights, market surveillance authorities, customs authorities, economic operators and consumers should have immediate access to the respective information on the toy through the data carrier.
Contact details
- Where an economic operator is required to provide their contact details, these details must now include an electronic address at which they can be contacted.
Enhanced obligations for all economic operators
- New obligations will be introduced for all economic operators, many relating to the DPP and data carrier requirements, and the obligation of various economic operators to check that they are present.
- Economic operators selling via online marketplaces must supply the online marketplace 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 prior to purchase.
- New obligations will be introduced for fulfilment service providers to ensure that the conditions during warehousing, packaging, addressing or dispatching, do not jeopardise the toy’s conformity with essential safety requirements.
- Specific obligations are also introduced for online marketplaces. These include the obligation to ensure that their online interface is designed in such a way that it allows economic operators to provide certain information, such as the CE marking, warnings and the data carrier through which the DPP can be accessed.
Exclusion from scope
- Reading and educational books intended for children older than 36 months, that do not have a play value are not considered to be toys.
Hygiene
- Toys that are intended to be put in the mouth shall be designed and manufactured in such a way that they can be cleaned.
Chemical Requirements
- The presence in toys, components of toys or micro-structurally distinct parts of toys, of substances in the form classified in Part 3 of Annex VI to the CLP Regulation (1272/2008) in any of the following categories is prohibited:
- carcinogenicity, germ cell mutagenicity or reproductive toxicity (CMR) category 1A, 1B or 2;
- endocrine disruption for human health category 1 or 2;
- specific target organ toxicity category 1, either in single exposure or in repeated exposure;
- respiratory sensitisation category 1.
- skin sensitizers category 1A.
- The intentional use of per- and polyfluoroalkyl substances (PFAS) is prohibited.
- The presence in toys of 10 bisphenols is prohibited.
- Toys shall not have a biocidal function or be treated with, or intentionally incorporate, one or more biocidal products, as defined in Article 3(a) of Regulation (EU) 528/2012 (note that some derogations apply).
- Appendix C chemical restrictions present in current Directive will now apply to toys for children of all ages.
- A migration limit for N-nitrosamines and N-nitrosatable in slimes and putties is introduced.
- The migration limit for Bisphenol A is lowered to 0.005 mg/l
- Migration limits for polymeric materials introduced for:
- Styrene,
- Acrylonitrile,
- Butadiene,
- Vinyl chloride.
Fragrances
- The lists of fragrances have been updated.
- Restricted allergenic fragrance limit reduced to 10 mg/kg.
- Action limit for labelling of toys containing certain allergenic fragrances reduced to 10 mg/kg.
- Where this labelling is required, it must also be listed in the DPP.
- Toys intended for use by children under 36 months or other toys intended to be placed in the mouth shall not contain any allergenic fragrances that are subject to the specific labelling requirements.
Implementation
- The new Regulation will enter into force on the twentieth day following that of its publication in the Official Journal of the European Union and the current Toy Safety Directive 2009/48/EC will be repealed 54 months after the date of entry into force of this Regulation.
Further Information
The full text is available for free downloaded via the following link:
https://data.consilium.europa.eu/doc/document/ST-10091-2025-INIT/en/pdf
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