EU Expands Ban on Hazardous Substances in Cosmetics with Regulation 2025/877

The European Commission has adopted Regulation (EU) 2025/877, updating the EU Cosmetics Regulation (EC) No 1223/2009 to strengthen consumer safety by banning additional hazardous substances. This amendment adds newly classified Carcinogenic, Mutagenic, or Reprotoxic (CMR) chemicals to the list of prohibited substances in cosmetic products.

Key Updates in Regulation 2025/877

1. Addition of 21 New CMR Substances to Annex II

Following recent updates to the CLP Regulation, 21 substances classified as CMR have been fully banned in cosmetics. Notable bans include:

• Trimethylbenzoyl Diphenylphosphine Oxide (TPO): Previously allowed under restrictions in nail products, now completely prohibited.
• Bisphenol AF, Tetrabromobisphenol A, 4-Methylimidazole: Known for carcinogenic or endocrine-disrupting effects.
• Organotin Compounds (e.g., Dibutyltin Oxide, Dibutyltin Maleate): Recognized as reprotoxic and banned.
• Complex reaction masses with bisphenols and phosphonium salts: Now prohibited due to toxicity.

All these substances are banned regardless of concentration or product type.

2. Removal of TPO Restriction in Annex III

The previous allowance for TPO in artificial nail systems (up to 5% for professional use) has been eliminated by deleting Entry 311 in Annex III. TPO is now fully banned under Entry 1730 in Annex II.

3. Clarification of Cymoxanil Prohibition

The entry for Cymoxanil (Entry 1580) has been updated to include its IUPAC name and CAS number (57966-95-7), aiding regulatory enforcement and product compliance verification.

Regulatory Timeline

From September 1, 2025, all cosmetic products sold in the EU must comply with the updated regulation. Non-compliant products must be withdrawn or reformulated.

Industry Actions Required

• Audit Ingredients: Review product formulations for banned substances.
• Reformulate: Replace banned substances with safe alternatives.
• Update Product Information Files (PIFs): Reflect changes and safety reassessments.
• Revise Notifications: Update data in the Cosmetic Products Notification Portal (CPNP).
• Withdraw Non-Compliant Products: Ensure all products on the market meet the new standards by the deadline.

Reference: EUR-Lex: Regulation (EU) 2025/877 (JRC)