Proposed European Restriction on Octocrylene (CAS 6197-30-4): Scientific and Regulatory Issues
- Rim Kaidi
- Nov 12
- 4 min read
Updated: 6 days ago
Octocrylene is a widely used ultraviolet (UV) filter in cosmetic products, particularly sunscreens, designed to absorb UVB and part of the UVA spectrum, thereby protecting the skin against the harmful effects of sunlight. Currently, octocrylene is authorised in cosmetic products at a maximum concentration of 9% in accordance with Annex VI of the European Cosmetics Regulation [1].
However, due to increasing environmental concerns, and following a proposal from the French Agency for Food, Environmental and Occupational Health & Safety (ANSES), the European Chemicals Agency (ECHA) launched in 2025 a public consultation concerning a potential restriction on the use of octocrylene in finished cosmetic products. This proposed restriction aims to prohibit octocrylene in cosmetic products at concentrations equal to or greater than 0.001% [2].
The public consultation will open on 24 September 2025 and close on 24 March 2026. Early comments are encouraged before 23 January 2026, to allow the Committees to consider feedback during their initial discussions. The final decision on this proposed restriction is expected in 2027, following the opinions of ECHA’s scientific committees and the European Commission [2].
1. Rationale for the Restriction
The primary objective of this restriction is to mitigate environmental risks arising from the widespread accumulation of octocrylene in aquatic environments. Although octocrylene is an effective UV filter for skin protection, it poses an environmental hazard due to its persistence and toxicity, particularly in aquatic ecosystems. Indeed, octocrylene is poorly biodegradable and may accumulate in the biological tissues of aquatic organisms [1].
2. Hazard Characterisation
The hazard profile of octocrylene is evaluated based on its ecotoxicological properties, including toxicity, persistence, and bioaccumulation potential.
• Persistence and limited biodegradability:Octocrylene is concluded to be persistent (P) and very persistent (vP) due to its low biodegradability, according to standard OECD 301 biodegradation tests. It displays high lipophilicity (log Kₒw > 6) and an aromatic structure, both indicators of potential bioaccumulation in biological tissues.Although environmental monitoring data suggest in situ accumulation in living organisms, in vivo fish studies indicate that octocrylene is neither bioaccumulative (B) nor very bioaccumulative (vB) under the bioaccumulation criteria of Annex XIII of REACH. Consequently, octocrylene is not classified as very persistent and very bioaccumulative (vPvB) [1].
• Aquatic toxicity:Octocrylene exhibits high chronic toxicity to aquatic organisms. Tests on Daphnia magna established a NOEC (No Observed Effect Concentration) of 2.66 µg/L for reproduction, indicating significant toxicity even at low concentrations. From this, a PNEC (Predicted No Effect Concentration) of 0.266 µg/L for freshwater can be derived [1].
3. Risk Characterisation
The environmental risk assessment combines both the hazard profile of octocrylene and the actual exposure conditions in aquatic environments. The risk is expressed as the ratio between the Predicted Environmental Concentration (PEC) and the Predicted No Effect Concentration (PNEC).
Risk Characterisation Ratios (RCR): The RCRs—comparing PEC to PNEC—are used to assess risk under various exposure scenarios. RCR values exceed 1 in most cases. In the scenario related to emissions during bathing in freshwater lakes (ES 12), RCR values are calculated at 744 for freshwater and 7443 for freshwater sediments.For marine coastal waters, the RCR is 109 for water and 1108 for sediments. These values indicate that actual concentrations of octocrylene in the environment far exceed the PNEC of 0.266 µg/L, suggesting an unacceptable environmental risk [1,2].
Emission and dissemination pathways: The main emission routes of octocrylene into the environment include:
Direct release during swimming, where up to 50% of the applied amount may be washed off into the water [2];
Indirect release via domestic wastewater, leading to the dissemination of octocrylene into agricultural soils and watercourses, thereby increasing aquatic contamination [1,2].
Such widespread and persistent emissions contribute significantly to aquatic pollution and heighten environmental risk.
4. Proposed Restriction
The restriction proposal under public consultation aims to ban the use of octocrylene in finished cosmetic products at concentrations ≥ 0.001%. This measure seeks to reduce emissions of the substance into the environment, mainly by limiting its use in cosmetics, which constitute the primary source of exposure [1,2].
5. Scientific and Industrial Implications
Key strengths of the restriction:
Protection of aquatic ecosystems: Octocrylene is toxic to many aquatic organisms even at low concentrations. Restricting its use would help preserve aquatic ecosystem integrity [1].
Availability of substitutes: Several next-generation UV filters with more favourable environmental profiles are available as potential alternatives to octocrylene in cosmetic formulations.
Precautionary principle: Reducing exposure to this substance aligns with the REACH Regulation’s objectives to minimise exposure to persistent and toxic chemicals [1].
Limitations and uncertainties:
Bioaccumulation uncertainty: Although persistent, the bioaccumulation potential of octocrylene in aquatic organisms remains insufficiently characterised [1].
Ecological substitutes: While alternative UV filters exist, their environmental profiles have not yet been fully validated, which may hinder their immediate implementation [2].
6. Conclusion
Assessments by France and ECHA conclude that the widespread use of octocrylene represents an unacceptable environmental risk under REACH criteria. The key hazard elements, chronic toxicity, persistence, and wide diffusion, justify a preventive regulatory action.The proposed restriction, setting a threshold of 0.001%, represents a strong regulatory measure to protect aquatic ecosystems, while granting industry sufficient time to adapt.
Octocrylene exemplifies the balance between environmental protection and human health safety. The European Commission’s final decision will need to ensure a transition towards safe, efficient, and sustainable cosmetic products.
References
French Agency for Food, Environmental and Occupational Health & Safety (ANSES). Regulatory Management Option Analysis (RMOA) on Octocrylene. Report for public consultation, March 2023. Available on the official ANSES website. (2023)
European Chemicals Agency (ECHA). Annex XV Restriction Report: Proposal to restrict Octocrylene (CAS 6197-30-4). Consultation launched on 24 September 2025, closing on 24 March 2026. Accessible via the ECHA website. (2025)
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