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update:2025-04-21NO.: DOC250401-01

EU pulished draft Toy Safety Regulation (TSR)( C/2025/1032)

In February 2025, EU published communication C/2025/1032 on new draft Toy Safety Regulation TSR. The proposal toy safety regulation (TSR) aims to replace the current Directive 2009/48/EC (Toy Safety Directive, TSD) and has made significant adjustments in multiple aspects. If approved, this Regulation will enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

The main changes of draft TSR compared to the current TSD are as follows:

1. Introduce a digital product passport (DPP) to replace the original EC Declaration of Conformity (DoC).

2. Require manufacturers of digitally connected toys to assess any risk posed to children's mental health and cognitive development and incorporate them into essential safety requirements.

3. Emphasize online sales supervision: Online markets must comply with Article 22 of the General Product Safety Regulation (GPSR, 2023/988/EU).

4. Add the following products that are not considered as 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.

5. Strengthen chemical safety control:
- Expand the scope of prohibited substances and add the following categories substances:
a. Endocrine disruption (ED) category 1 or 2, for human health (HH) and the environment (ENV)
b. Specific target organ toxicity (STOT) category 1, either in single exposure or in repeated exposure
c. Respiratory sensitization category 1
d. Skin sensitization category 1
e. Persistent, bioaccumulative and toxic (PTB)
f. Very persistent, very bioaccumulative (vPvB)
g. Persistent, mobile and toxic (PMT)
h. Very persistent, very mobile (vPvM)
-Add specific prohibited substances:
a. Prohibiting per- and polyfluoroalkyl substances (PFAS) and bisphenols in toys.
b. Toys intended for use by children under 36 months or other toys intended to be placed in the mouth shall not contain any fragrances.
-Reduce the requirements for some chemical restricted substance:
a. Prohibit the use of chromium (VI), cadmium, mercury, and lead unless their presence is technically unavoidable according to good manufacturing practices (GMP) and each substance does not exceed the limit of detection (LOD) in the homogeneous material.
b. Restrict nitrosamines and nitrosatable substances in all toys: nitrosamines migration ≤ 0.01 mg/kg, nitrosatable substance migration ≤ 0.1 mg/kg.
c. Restrict 11 chemicals in all toys, including TCEP, TCPP, TDCP, formamide, BIT, 3:1 mixture of CMI and MI, CMI, MI, Phenol, formaldehyde, and aniline.
d. Update the prohibition for 58 allergenic fragrances unless their presence in the toy is technically unavoidable under GMP and the limit has been reduced from the current 100mg/kg to 10mg/kg.
e. Update the requirements for allergenic fragrances that require labeling. These substances must be listed to be listed on the toy, its affixed label, packaging or in an accompany leaflet as well as in the DPP, if those allergens are added to a toy, where they concentrations exceed 10 mg/kg.

6. Update label and warning requirements:
-Toys not suitable for children under 36 months old, warning pictograms with a diameter of at least 10 millimeters.
-The word 'warning' can be replaced with a specific icon.

According to the draft legislation, it shall apply from the first day of the month following 30 months after the date of entry into force of this Regulation, except for a few provisions that will apply from the date of entry into force.

For further details, please refer to the below link:
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C_202501032


 

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