EU Publishes Its Amended Draft Toy Safety Regulation
On 27 February 2025, the European Union (EU) published an amended draft for a proposed Regulation on the Safety of Toys (TSR) and repealed Directive 2009/48/EC (the current Toy Safety Directive), in accordance with the EU resolution of 13 March 2024.
Substantial Changes
The important amendments in this draft are, inter alia:
Digital Product Passport
The digital product passport should replace the EU declaration of conformity (DoC) under Directive 2009/48/EC (the Toy Safety Directive), Directive 2014/53/EU (Radio Equipment Directive) and any other Union legislation applicable to toys.
In the digital product passport, there should be a link to the Safety Business Gateway and to the section of the Safety Gate Portal for the transmission of information about toys that might present a risk to the health and safety of consumers.
Manufacturers should:
- create a digital product passport for the toy;
- upload the unique product identifier and the unique operator identifier of the toy to the digital product passport registry;
- keep the digital product passport up-to-date according to reasonable best efforts and make any necessary changes when required;
- 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 model covered by that documentation and digital product passport has been placed on the market.
Toys with Artificial Intelligence (AI)
Under the future harmonised rules on artificial intelligence, toys containing AI systems as safety components are considered as high-risk AI. Furthermore, under the Cyber Resilience Act internet connected toys that have social interactive features (e.g., speaking or filming) or that have location tracking features are considered important products with digital elements (Class I). On the basis of these Regulations, such toys require a third-party conformity assessment, unless the manufacturer has applied the relevant harmonised standards.
Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
Per- and polyfluorinated alkyl substances (PFASs) are a large family of more 10 000 man-made chemicals.
Exposure to the most studied PFASs has been associated with a range of adverse health effects, including thyroid disease, liver damage, obesity, diabetes and reduced response to routine vaccinations, as well as increased risk of breast, kidney and testicular cancer.
Therefore, toys should not contain any per- and polyfluorinated alkyl substances.
Other Chemicals Control
Toys shall not contain chromium VI, cadmium, mercury and lead, unless their presence is technically unavoidable under good manufacturing practice and does not exceed the limit of detection in the homogeneous material.
Nitrosamines and nitrosatable substances are prohibited in all toys.
The migration of those substances from toys, components of toys or micro-structurally distinct parts of toys, shall not exceed 0.01 mg/kg for nitrosamines and 0.1 mg/kg for nitrosatable substances
Warnings
All warnings shall be preceded by the word ‘Warning’ or, alternatively, by a generic pictogram such as the following pictogram, which shall be displayed in a prominent way.
Toys which might be dangerous for children under 36 months shall bear a warning such as ‘Not suitable for children under 36 months’ or ‘Not suitable for children under three years’ or a warning in the form of the following pictogram:
The pictogram shall be at least 10 mm diameter in size and shall contain a red circle with a white background and with the text and face in black.
Effective Date
This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
References
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C_202501032
