EU Toy Safety Regulations(TSR): Major Revisions in the Draft Amendment
On February 27, 2025, the European Commission published the draft amendment to the Toy Safety Regulations (TSR) in its Official Gazette (Notification C/2025/1032). This draft is of great significance, and its goal is to replace the Toy Safety Directive (Directive 2009/48/EC, TSD), which has been implemented in the EU market for 16 years. Once the draft is successfully approved, according to regulations, the Toy Safety Regulation will officially take effect on the 20th day after it is published in the EU Official Gazette and will quickly exert a binding effect on safety regulations in the toy market. This draft makes significant revisions to the TSD, covering (but not limited to) the following aspects:
It is clearly stated that the following two types of products do not fall within the category of toys:
• Scooters for children weighing more than 20 kilograms.
• Books made entirely of paper/cardboard (without other materials or components) for children over 36 months old.
For toys that interact or connect with external devices (such as smartphones, tablets, the Internet, or other smart devices) through digital technology, manufacturers are required to incorporate the risks that the products pose to children's mental health and cognitive development into the scope of basic safety requirements for consideration.
The DPP is specific product data (such as a QR code if applicable) containing the DoC and other information that can be accessed through an electronic data carrier. The European Commission must, within 12 months after the TSR comes into force, adopt an implementing act to clarify the technical requirements related to the DPP. At the same time, within 12 months after the TSR comes into force, issue guidelines for the implementation of the DPP and customized instructions, and provide automatic translation tools in the official languages of the member states' markets.
Ensure that people are aware of any risks associated with toys. Especially in the scenarios of remote and online sales, it is necessary to ensure that online warnings are clear, legible, and immediately visible (for example, displaying the warning text on the product details page).
For example, online platforms are required to register on the Safety Gate Portal and indicate the information of their single point of contact on this portal.
It is required to assess the exposure risks of single chemical substances, as well as the combined exposure hazards of different chemical substances in toys, while taking into account the obligations under the REACH regulation and the requirements specified therein.
Expand the categories of carcinogenic, mutagenic, or reprotoxic substances prohibited in toys, specifically including:
• Endocrine disruptors (ED) Category 1 or 2 (both for human health and the environment).
• Specific target organ toxicity (STOT) Category 1.
• Respiratory sensitization Category 1.
• Skin sensitization Category 1.
• Persistent, bioaccumulative, and toxic (PBT).
• Very persistent and very bioaccumulative (vPvB).
• Persistent and mobile (PMT).
• Very persistent and very mobile (vPvM).
• Per- and polyfluoroalkyl substances (PFAS).
• Bisphenol Substances.
The specific changes are as follows:
• Maintain the migration limits of the original 15 elements (aluminum, antimony, arsenic, barium, boron, chromium (III), cobalt, copper, manganese, nickel, selenium, strontium, tin, organotin, and zinc), and delete the migration limits of hexavalent chromium, cadmium, mercury, and lead. Add the provision that "toys shall not contain hexavalent chromium, cadmium, mercury, and lead, unless their presence is technically unavoidable under good manufacturing practices and does not exceed the detection limit of the homogeneous material."
• Limit the substances of nitrosamines in all toys: ≤ 0.01 mg/kg of the migration amount of nitrosamines; ≤ 0.1 mg/kg of the migration amount of nitrosatable substances.
• Delete Appendix C of the original TSD. Bisphenol A (BPA) is removed. The other 11 restricted chemical substances (TCEP, TCPP, TDCP, formamide, BIT, a 3:1 mixture of CMI and MI, CMI, MI, phenol, formaldehyde, and aniline) are moved to the chemical property requirements for all toys. And the formaldehyde release limit for wood materials is revised from 0.1 ml/m³ to 0.062 mg/m³, which is the same as the formaldehyde release limit in Annex XVII of the REACH regulation.
• Allow the presence of 58 allergenic fragrances in cases where it is technically unavoidable and in compliance with GMP, but the content shall not exceed 10 mg/kg (currently 100 mg/kg). If the concentration of 71 allergenic fragrances exceeds 10 mg/kg (currently 100 mg/kg), they need to be listed on the toy, its attached label, packaging, or the accompanying brochure, as well as in the DPP.
There are many changes in this draft amendment to the EU Toy Safety Regulations. Relevant enterprises should pay close attention and make preparations in advance to ensure that their products meet the requirements of the new regulations.