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On February 27, 2025, European Parliament released the legislative resolution on the proposal for a new EU Toys Safety Regulation (TSR) repealing Directive 2009/48/EC (C/2025/1032), adopted at first reading on March 13, 2024.
The draft TSR introduces substantial changes to the existing content, taking into account of the latest technical and scientific progress. Noticeable changes involve the restriction of more hazardous substances that pose significant risks to human health, in alignment with the CLP and REACH amendment.
The highlights of new requirements are summarized below:
1. Expand the ban on CMR substances or mixtures used in toys, components of toys or micro-structurally distinct parts of toys to include the following categories:
endocrine disruption category 1 or 2, for human health and the environment;
skin sensitization category 1;
persistent, bioaccumulative and toxic (PBT);
very persistent, very bioaccumulative (vPvB);
persistent, mobile and toxic (PMT);
very persistent, very mobile (vPvM).
2. Introduces ban on the use of per- and polyfluoroalkyl substances (PFAS) and of bisphenols in toys, components of toys or micro-structurally distinct parts of toys. Accordingly, the limit values for Bisphenol A intended for use by children under 36 months or in other toys intended to be placed in the mouth is removed from Appendix C.
3. Delete the specific migration limits for cadmium, chromium (VI), lead, mercury. The use of these highly toxic elements is now banned in toys, unlee their presence is technically unaviodable under good manufacturing practice and does not exceed the limit of detection in the homogeneous material.
4. Amends the migration limits for nitrosamines and nitrosatable substances to 0.01 mg/kg for nitrosamines and 0.1 mg/kg for nitrosatable substances.
5. Amends the limit values for formaldehyde. The emission limit in wood toy material is changed from 0.1 ml/m3 to 0.062 mg/m3, which is now consistent with the formaldehyde emission limits specified in entry 77 to Annex XVII of REACH (Restriction List)
6. Amends the limit values for fragrance allergens present in toys that are technically unavoidable from 100 mg/kg to 10 mg/kg. For those exceeding the 10 mg/kg threshold values, in addition to listing the fragrance allergens on an affixed label, on the packaging or in an accompanying leaflet, they should also be included in the digital product passport.
In addition, the draft TSR is also mandating the manufacturers to create a digital product passport (DPP), in replace of the EU declaration of conformity (DOC) required. The DPP should include but not limit to:
Unique product identifier
Name and address of manufacturer or authorized representative
Commodity code
DOC references
CE marking
List of allergenic fragrances if applicable
Considering the majority of toy manufacturers subject to the TSR requirements are micro, small and medium sized enterprises (SMEs), for which drawing up a DPP is a significant challenge from an administrative and operational perspective, the Commission shall provide tailor-made guidance on how to efficiently set up and operate a DPP for toys and evaluate the possibility of setting up an online tool to provide SMEs with the basic information and functions necessary to establish a DPP for their products.
The draft TSR also exempts the following two 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, that are made entirely of paper or cardboard, without additional materials or components.
This regulation will enter into force 20 days after its publication in the Official Journal of the European Union.
A transitional period of 30 months is provided after EIF of the TSR, except for a few provisions that will apply from EIF date.
The existing Directive 2009/48/EC shall be repealed on the same day after the end of transitional period.
The draft TSR is accessible here.
