On December 12, 2025, the EU officially issued the Toy Safety Regulation (EU) 2025/250 (hereinafter referred to as TSR), marking a major upgrade to the EU toy safety regulatory system. This regulation will come into effect on January 1, 226, and a transition period of up to 55 months has been set, with full enforcement scheduled for August 1, 2030
Reference link：http://data.europa.eu/eli/reg/2025/2509/oj
Key adjustments to regulations:
Revolution in physical, mechanical and combustibility requirements
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Legal form of application transformation | The TSR is directly applicable in all EU Member States in the form of "regulations", without the need for the Member States to convert it into domestic, which thoroughly solves the problem of differences in the implementation of previous directives in various countries and achieves the unification of regulatory standards. |
Compliance proof and traceability system upgrade | Replace the original EU Declaration of Conformity (DoC) with a "Digital Product Passport (DPP)", which is required to be unique actually attached to the toy, label, or packaging, ensuring that consumers can directly view it during the sales process (including online sales) without the need for additional software downloads orrations. Operators are required to upload the DPP to the EU registration system before the product is placed on the market, and to enter the unique product identifier and operator identifier, the DPP data is only allowed to be stored by the creator, and it is forbidden for other subjects to sell or reuse. |
CE mark and warning sign optimization | The CE mark shall be marked on the toy and packaging, and if it cannot be directly marked on the toys displayed on the counter, it shall be supplement at the display position; the CE mark shall be followed immediately by a safety icon or warning information. The warning instructions shall clearly state the use restrictions, including key indicators such as age, ability, weight, etc., and products sold online shall ensure that consumers can clearly see the warning content. The warning information can use a triangular graphic symbol instead of the "" text, and the height of the graphic symbol shall not be less than 10 mm. |
Enhanced Supervision of Special Toys | Toys with AI functions subject to third-party conformity assessment are classified as high-risk AI systems and in addition need to comply with the network and security, and radio equipment related regulations; connected toys with social interaction or geolocation tracking functions are recognised as Class I important digital element products and need to undergo third-party conform assessment (excluding where a harmonised standard is applied that achieves a “substantial” assurance level). |
Expansion of security assessment dimensions | The toy safety evaluation now includes the impact on children's mental health and cognitive development for the first time, and special content such as food imitation, intest blockage risk, and magnet use has been added to the basic safety requirements. |
Refined electronic and electrical requirements
For small electronic toys with batteries, TSR proposes clear anti-access requirements: battery design needs to ensure that it is not possible to access without the use tools; if limited by the size or characteristics of the toy, rechargeable batteries can be designed as non-removable structures, allowing only professional personnel to perform replacement or dis operations, reducing the safety risk of children accidentally touching batteries at the source.
Strict upgrade of chemical safety requirements
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Expansion of the scope of prohibited substances | In addition to the original categories of carcinogens, reproductive toxins, and mutagens (CMR Cat.1A, 1B, 2) new categories of banned substances include endocrine disruptors (Cat.1, 2 for human health), target organ toxins (Cat.1 for acute/repeated exposure, respiratory sensitizers (Cat.1), and skin sensitizers (Cat.1A). |
Chemical limits for specific products are clearly stated | For the first time, limits on "nitrosamines and their precursors" were set in slime and putty, respectively 0.2 mg/kg and 1 mg/kg; and the control of 10 substances such as TCEP, formaldehyde, and bisphenol A (PA) was fully implemented for all toys used by children under 14 years old (the original regulation only applied to toys used by children under 36 months old or toys can be put in the mouth). |
Tightening of critical substance limits | The migration limit for bisphenol A (BPA) has been significantly reduced from 0.04 mg/L to 0.00 mg/L; the limit for single substances of sensitizing fragrances has been tightened from 100 mg/kg (0.01%) to 10/kg (0.001%) and further information must be provided in the DPP when the labelling obligation is triggered. |
Add new single substance control | For toys for children under 14 years old, the migration limits of acrylonitrile (0.01 mg/L), butene (0.07 mg/L), styrene (0.77 mg/L), and chloroethylene (0.01 mg/L) set for the first time. |
Special substance ban introduced | Prohibit the intentional use of per- and polyfluoroalkyl substances (PFASs) in toys; explicitly ban 10 bisphenol (possibly to be extended to 34 in the future); toys must not be biocidal products or treated articles under the EU BPR regulation, with the exception of outdoor placed toys and certain preservatives in leave-on cosmetics. |
Exemption clause clarified | Cobalt in stainless steel as an impurity of nickel, cobalt in conductive components, cobalt in neodymium-based magnets that are swallowable/inhalable are exempted. In addition, the European Commission will ask ECHA for its opinion on the safety of nitrosamines and their precursors lead, cadmium, mercury, and hexavalent chromium in toys within 12 and 24 months after the publication of the Regulation, which could lead to optimisation of the relevant control requirements. |
Industry compliance response suggestions
Toy safety regulations are constantly being upgraded with the application of new materials, the development of smart technology and the coordination of global standards. The implementation of TSR this time not only strengthens the control of traditional safety risks, but also focuses on new risks such as data privacy of smart toys and safety hazards of networked products, improving market supervision efficiency and transparency through digital means, and significantly strengthening the regulatory requirements for online sales channels. In order to help relevant enterprises smoothly transition through the 4.5year transition period, it is suggested that: Comprehensive compliance assessment should be carried out, product design and production should be optimized, a digital product passport system should be established, supply management should be strengthened, and regulatory dynamics should be continuously monitored.
The implementation of the EU TSR regulation is not only a test of the product safety capabilities of toy enterprises, but also an opportunity to promote the high- development of the industry. Relevant enterprises need to attach great importance to compliance preparation, comprehensively improve product safety standards during the transition period, and ensure smooth entry into the EU market sustainable and healthy development.
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