EU Proposes Significant Tightening of Chemical Controls in Toys

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. The draft is currently open for public consultation, with stakeholders invited to submit comments by October 10, 2026. 

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.

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.

What CIRS Can Do for You

CIRS Group is a leading provider of comprehensive regulatory compliance services and solutions for chemicals, cosmetics, food and food-related products, agrochemicals, and medical devices. Its chemical team consists of experts with extensive knowledge in chemistry, toxicology, environmental science, and related fields. They are well-versed in various international regulations, including but not limited to EU REACH, CLP, GHS, TSCA, and K-REACH. Our chemical compliance services in the EU cover:

CIRS Services

• EU REACH Registration (including OR services);
• EU REACH Evaluation Compliance Services;
• SVHC Testing;
• PPWR Compliance Services;
• EU CLP Compliance;
• EU Poison Center Notification;  
• EU BPR Compliance;
• EU PoPs Compliance;
• PFAS Testing
• Toy Testing

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further information

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