European Commission Limits 12 Cosmetic Ingredients Due to Health Risks

These changes follow updated safety assessments conducted by the Scientific Committee on Consumer Safety (SCCS) and apply to the annexes concerning prohibited substances (Annex II) and restricted substances (Annex III). Minor amendments are also made regarding colorants (Annex IV), preservatives (Annex V), and UV filters (Annex VI). The regulation will be binding across all EU member states from the effective date, requiring compliance from manufacturers, which may involve reformulating products with banned ingredients and updating safety assessments.

Among the 12 updates, triphenyl phosphate has been added to Annex II, prohibiting its use in cosmetics due to concerns about its potential endocrine-disrupting and genotoxic qualities. Previously assessed in July 2024, SCCS found the evidence concerning its safety insufficient. Consequently, the EC concluded that the risks associated with triphenyl phosphate necessitate its prohibition.

Conversely, silver zinc zeolite, once prohibited under Annex II due to its classification as “Toxic for Reproduction Category 2,” has been moved to Annex V. This decision was based on an industry defense highlighting the lack of available preservatives. The SCCS determined in 2023 that silver zinc zeolite is safe in concentrations up to 1% in spray deodorants and powder foundations, provided that the silver content does not exceed 2.5%.

Additionally, the updates to Annex III included modifications to substances already categorized. Benzyl salicylate, aluminum compounds, and water-soluble zinc salts retain their classifications but have revised conditions for use. Benzyl salicylate is now deemed safe as a fragrance allergen at concentrations above 0.001% in leave-on products and 0.01% in rinse-off products.

The regulation also clarifies restrictions on water-soluble zinc salts for oral care products used by children. Newly included substances such as zinc citrate and various forms of zinc sulfate can be utilized at concentrations of up to 1%, but not exceeding 0.72% in products for children under one year old.

Aluminum and aluminum-containing ingredients continue to be considered safe based on specific usage conditions.

Changes to Annexes IV, V, and VI include updated regulations for colorants, with specified usage concentrations for certain dyes in hair products. For example, HC blue no. 18 is restricted to on-head concentrations of up to 0.35%, while HC red no. 18 has limits ranging from 1.5% in oxidative hair dye to 0.5% in non-oxidative applications.