The regulation stems from classifications established in Commission Delegated Regulation (EU) 2024/197, which identified these substances as posing unacceptable risks to human health in consumer-facing products.
Key Substances and Their Industrial Uses
Among the banned substances is Trimethylbenzoyl Diphenylphosphine Oxide, previously permitted in professional-use nail systems for its photoinitiating properties. Also included are Tetrabromobisphenol-A and Bisphenol AF, commonly used for their stabilising and flame-retardant functions in packaging and formulation components.
The list extends to:
- Pesticidal actives such as Clothianidin and Transfluthrin
- Organotin compounds like Dibutyltin Maleate and Dibutyltin Oxide
- Aromatic amines and isocyanates, including N,N-Dimethyl-p-toluidine and 3,3'-Dimethylbiphenyl-4,4'-diyl Diisocyanate
- Several reaction mass mixtures involving bisphenol derivatives and fluorinated compounds
These substances are now listed in Annex II of Regulation (EC) No 1223/2009, prohibiting their use in any cosmetic formulation within the EU market.
Compliance Timeline and Sector Implications
The deadline for compliance is 1 September 2025, aligning with the application date of their CMR classifications. There have been no approved exceptions for continued use in cosmetic products.
This development demands immediate action from stakeholders, including:
- Cosmetic formulators to review and reformulate products
- Raw material suppliers to reassess portfolios
- Retailers and importers to audit their supply chains
Non-compliance could result in product recalls, legal liabilities, and loss of EU market access.
