The European Union will revise the Toy Safety Directive 2009/48/EC regarding the fragrance Lilial, the limit for Bisphenol A and applicable methods for certain substances.
Background
Toy Safety Directive (2009/48/EC) sets general prohibition of 58 allergenic fragrances in toys and lists 72 fragrances with obligations for labelling.
The fragrance Lilial (2-(4-tert-butylbenzyl) propionaldehyde (CAS 80-54-6)) is currently listed as a fragrance which should be labelled if the concentration exceeds 100 mg/kg. It is proposed to add Lilial to the list of prohibited allergenic fragrances in toys and delete it from the table which requests labelling.
Appendix C to Annex II lays down specific limit values for chemicals in toys intended for children under 36 months or in other toys intended to be placed in the mouth. Apart others, requirements are defined for Bisphenol A, Phenol, and 1,2-benzisothiazol-3(2H)-one (BIT), referring to the test methods EN 71-10 and EN 71-11. Meanwhile specific methods are developed for these substances: Bisphenol A (EN 71-19), Phenol (EN 71-18), and 1,2-benzisothiazol-3(2H)-one (BIT) (EN 71-17). Therefore, references to EN 71-10 and EN 71-11 should be deleted.
For Bisphenol A the current limit under Appendix C is 0,04 mg/l, which was based on a scientific calculation from 2015. And updated opinion of European Food Safety Authority (EFSA) in 2023 concludes that there is additional health concern. Therefore, the limit for Bisphenol A should be reduced to 0,005 mg/l as migration limit.
The European Union (EU) has notified the World Trade Organization (WTO) about the intent to revise the Toy Safety Directive.
Comments can be given until 10th October 2026. Adoption of the draft directive and enter into force is expected in Q4 2026.
National application is proposed 12 months after publication in the Official Journal.
Proposed Directive: EUR-Lex - Ares(2026)7715229 - EN - EUR-Lex
WTO Notification: NOTIFICATION
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