On August 11, 2026, the European Commission published a draft directive proposing significant amendments to Annex II of the Toy Safety Directive (2009/48/EC), establishing stricter control standards for allergenic fragrances, bisphenol A (BPA), phenol, and benzisothiazolinone (BIT) in toys.
Key Amendments
1. Allergenic Fragrance (Lilial)
- Lilial (2-(4-tert-butylbenzyl)propionaldehyde, CAS 80-54-6) will be removed from the list of "permitted but subject to labeling requirements" and transferred to the prohibited substances list.
- Reason: The substance has been classified as toxic to reproduction Category 1B, applicable since March 2022, and should no longer be permitted in toys.
2. Bisphenol A (BPA)
- Based on the European Food Safety Authority's (EFSA) updated scientific assessment in 2023 (which significantly lowered the tolerable daily intake to 0.2 ng/kg body weight), the migration limit for bisphenol A will be reduced from 0.04 mg/L to 0.005 mg/L.
- Testing will be conducted using the new standard EN 71-19:2025.
3. Phenol and Benzisothiazolinone (BIT)
- References to the old standards EN 71-10/11 in the original Appendix C will be removed and replaced with new standards published in 2025:
- EN 71-17 (BIT)
- EN 71-18 (Phenol)
- EN 71-19 (Bisphenol A)
- Phenol: The migration limit in polymeric materials is 5 mg/L; the content limit as a preservative is 10 mg/kg.
- BIT: The content limit in aqueous toy materials is 5 mg/kg.
The draft is currently open for public consultation, with stakeholders invited to submit comments by October 10, 2026. According to the draft schedule, the directive is expected to enter into force in Q4 2026. Member States will be required to transpose the directive into national legislation within 12 months of its publication, and the new rules will formally apply 12 months after publication.
