EU Announces Draft Regulation on Toy Safety

SG 039/25

The European Union (EU) has issued its amended draft Toy Safety Regulation (TSR). If approved, it will enter into force (EIF) on the 20th day following its publication in the Official Journal of the EU.

In February 2025, the EU published communication C/2025/1032 on its draft TSR. This document is the position of the European Parliament, adopted at first reading in March 2024, with a view to the adoption of the draft TSR and the repeal of Directive 2009/48/EC (Toy Safety Directive, TSD, current consolidated version to December 2022).

The draft TSR contains substantial changes to the TSD, including but are not limited to:

• Replacing the EU declaration of conformity (DoC) with the digital product passport (DPP), a set of product-specific data that includes the DoC and additional information accessible electronically via a data carrier (Chapter IV and Annex VI). The Commission must adopt delegated acts within 12 months after the date of EIF of the TSR to determine the technical requirements related to the DPP
• Requiring manufacturers of digitally connected toys to consider risks posed to children’s mental health and cognitive development as part of the essential safety requirements
• Emphasizing that online marketplaces must comply with Article 22 to Regulation (EU) 2023/988 on product safety (SafeGuardS 88/23)
• Entrusting the Commission with issuing practical guidelines and tailor-made guidance to assist small and medium sized enterprises (SMEs) in establishing a DPP. Additionally, an automatic translation tool must be provided for the official language(s) of the Member State where the toy is marketed. These must be provided within one year after the date of EIF of the TSR
• Requiring the chemical safety assessment to consider exposure to individual chemicals as well as combined exposure hazards from different chemicals in the toy
• Exempting the following products from the definition of toys:
• Scooters intended for children with a body mass of more than 20 kg
• Books intended for children older than 36 months, provided they are made entirely of paper or cardboard without additional materials or components


• Expanding the general ban on toys containing substances classified as carcinogenic, mutagenic or toxic for reproduction (reprotoxic, CMR substances) in Regulation (EC) No. 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP Regulation, current consolidated version to December 2024), to include the following categories:
• Endocrine disruption (ED) category 1 or 2, for human health (HH) and the environment (ENV)
• Specific target organ toxicity (STOT) category 1, either in single exposure or in repeated exposure
• Respiratory sensitization category 1
• Skin sensitization category 1
• Persistent, bioaccumulative and toxic (PTB)
• Very persistent, very bioaccumulative (vPvB)
• Persistent, mobile and toxic (PMT)
• Very persistent, very mobile (vPvM)


• Prohibiting per- and polyfluoroalkyl substances (PFAS) and bisphenols in toys
• Forbidding fragrances in toys for children under 36 months or other toys intended to be placed in the mouth
• Amending the requirements for chemical substances. These include, among other things, the following:
• Migration limits for 15 elements, including a prohibition on chromium (VI), cadmium, mercury and lead, unless their presence is technically unavoidable under good manufacturing practice (GMP) and each substance does not exceed the limit of detection (LOD)
• Restriction of nitrosamines and nitrosatable substances in (all) toys:
• ≤ 0.01 mg/kg for the migration of nitrosamines
• ≤ 0.1 mg/kg for the migration of nitrosatable substances
• Restricting 11 chemicals in (all) toys (TCEP, TCPP, TDCP, formamide, BIT, 3:1 mixture of CMI and MI, CMI, MI, phenol, formaldehyde and aniline). These chemicals are regulated under Appendix C of the TSD but this only applies to toys intended for children under 36 months or those intended to be placed in the mouth. It is worth noting that bisphenol A (BPA) is removed and the formaldehyde emission limit for wood materials is amended from 0.1 ml/m³ to 0.062 mg/m³, the latter of which is identical to the formaldehyde emission limit listed in entry 77 to Annex XVII of REACH (SafeGuardS 91/23)
• Update on the prohibition of allergenic fragrances by allowing their presence if technically unavoidable under GMP and does not exceed 10 mg/kg, reduced from the present 100 mg/kg
• Update the requirements for allergenic fragrances to be listed on the toy, its affixed label, packaging or in an accompany leaflet. Additionally, these substances must be included in the DPP if their concentrations exceed 10 mg/kg, reduced from the current 100 mg/kg


• Mandates a minimum diameter of 10 mm for the pictogram on toys that are not suitable for children under 36 months

According to the draft legislation, it will repeal the TSD on the first day of the month following 30 months after the EIF of the TSR.

A transitional period of 30 months (2½ years) is provided after the date of EIF, except for a few provisions that will apply from the date of EIF.

Toys that are compliant with the TSD before its repeal may remain on the market (may be sold out) until the first day of the month following 50 months after the EIF of the TSR.

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