Key takeaway
What This Development Means
The EU’s Regulation (EU) 2025/877 bans over 20 CMR substances in cosmetics, effective from 1 September 2025. Businesses across manufacturing and supply chains must act now to ensure compliance and maintain access to the European market.
What is Regulation (EU) 2025/877 and why does it matter?
This regulation bans the use of substances classified as carcinogenic, mutagenic, or toxic to reproduction (CMR) in cosmetic products. It affects product formulations, raw material sourcing, and compliance responsibilities for companies across the chemicals and cosmetics industries.
What are CMR substances and why are they banned in cosmetics?
CMR substances are chemicals classified as carcinogenic, mutagenic, or toxic to reproduction under EU law. They are banned in cosmetics to protect consumer health, particularly when safer alternatives are available and no exception is justified under strict regulatory criteria.
Source basis: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ%3AL_202500877
The European Commission has formally adopted Regulation (EU) 2025/877, banning the use of over 20 substances classified as carcinogenic, mutagenic, or toxic to reproduction (CMR) in cosmetic products. This amendment to Regulation (EC) No 1223/2009 will come into force on 1 September 2025, introducing significant implications for manufacturers, suppliers, and compliance officers across the chemicals and cosmetics value chain.
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.
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