On September 1, 2025, the European Union (EU) implemented a new legal framework for cosmetic products, prohibiting the use of two substances commonly found in nail polishes and semi-permanent gels: diphenylphosphine oxide (TPO) and dimethyl-p-toluidine (DMTA). This measure, established by Regulation (EU) 2025/877, addresses increasing concerns regarding the safety of cosmetic products and the protection of public health, in accordance with the precautionary principle that underpins EU regulatory policy.
Regulatory background
The ban on TPO and DMTA is part of the EU’s broader strategy to safeguard public health and consumer safety, particularly with respect to exposure to hazardous substances in everyday products. Regulation (EU) 2025/877 amends Regulation (EC) 1223/2009 on cosmetic products by adding both compounds to Annex II, which enumerates substances prohibited in cosmetics.
The European Commission’s decision is based on the scientific opinions from the Scientific Committee on Consumer Safety (SCCS) and the European Chemicals Agency (ECHA), both of which have identified significant risks associated with continuous exposure to TPO and DMTA. These risks are especially pronounced for industry professionals and frequent users, and include adverse effects on fertility, cellular mutations, skin and eye irritation, and potential carcinogenicity. The availability of robust scientific evidence has been instrumental in the EU’s application of the precautionary principle and its efforts to strengthen consumer protection.
Key legal aspects
- Classification and ban of CMR substances
- Scope and Obligations for Operators
Effective September 1, 2025, the manufacture, import, marketing, distribution, and both professional and domestic use of products containing TPO or DMTA within the European Union are strictly prohibited.
Products must be removed from the market and beauty salons, regardless of the date of purchase.
- Liability and regulatory compliance
Failure to comply with the prohibition may result in administrative sanctions and, in severe cases, civil liability for harm caused to consumers’ health. Operators are required to exercise the highest level of diligence in reviewing product formulations, labeling, and traceability, as well as in staff training.
Transparency and the provision of accurate information to consumers are of particular importance. Establishments must ensure that all products in use are fully compliant with current legislation.
- Transition and reformulation of products
The cosmetics industry has been required to reformulate its products, replacing TPO and DMTA with alternative photoinitiators considered safe, such as TPO-L or Bis-Trimethylbenzoyl Phenylphosphine Oxide. This process involves conducting new safety assessments and ensuring compliance with current regulations before products are placed on the market.
Conclusion
The ban on TPO and DMTA in nail polishes and semi-permanent gels represents a significant step forward in protecting public health and consumer safety in the EU. This measure not only reinforces the commitment of European authorities to preventing risks associated with hazardous chemicals, but also promotes greater responsibility within the cosmetics industry and throughout the supply chain. From a legal perspective, it requires the immediate adaptation of business practices, enhanced regulatory compliance monitoring, and ongoing updates to internal procedures.
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