EU octocrylene ban looming? France seeks industry expertise on risks to health and environment

04 Sep 2023 --- The French Ministry for Ecological Transition is seeking public opinions on the national health agency’s (ANSES) draft Regulatory Management Option Analysis (RMOA) project to determine whether the UV filter octocrylene requires measures regarding possible environmental risks and what they might be.

Following this public consultation, ANSES will finalize the RMOA, and the government will create a document of conclusions and, if necessary, a proposal to take measures at an EU level that may entail octocrylene’s restriction, partial or full ban or conditions based on preventing risks to the health of the environment.

The consultation opened on 26 July and is ending on 15 September this month.

ANSES is seeking any information on: “The available alternatives of octocrylene especially when used as a UV filter, biosurveillance data and uses of octocrylene.”

Current safety measuresFollowing this public consultation, ANSES will finalize the RMOA, and the government will create a document of conclusions and, if necessary, an EU proposal.
In EU regulations, octocrylene is authorized to be used as a UV filter up to 9 to 10%, depending on how it will be used, because of its potential endocrine-disrupting properties.

“While there are indications from some in vivo studies to suggest that octocrylene may have endocrine effects, the evidence is not conclusive enough at present to enable deriving a specific endocrine-related toxicological point of departure for use in safety assessment,” reads the Scientific Committee on Consumer Safety’s (SCCS) Final Opinion.

“Contact sensitization to octocrylene has been reported; however, considering the widespread use of octocrylene in cosmetic products, the number of reported cases of allergic contact dermatitis appears negligible.”

However, the SCCS did not consider octocrylene’s environmental effects.

Insufficient regulationsThe consultation is ending on 15 September this month.
ANSES is currently waiting on test results on octocrylene, carried out by importing and manufacturing companies, to conclude hazardous properties.

For now, it has identified the existence of “unacceptable risks” for the aquatic environment in some uses of the substances that concern cosmetics and plastisol formulation.

The draft RMOA contains ANSES’ findings proposing that placing an octocrylene restriction under the EU REACH (registration, evaluation, authorization and restriction of chemicals) Regulation is appropriate.

ANSES has also studied other regulatory measures, such as the CLP (classification, labeling and packaging of substances and mixtures) classification and substances of very high concern (SVHC). “But ANSES concludes that these measures are inadequate,” shares the Ministry for Ecological Transition.

Further investigations on relevant regulations were carried out on the Water Framework Directive and the Industrial Emissions Directive, for instance. “It appears that these directives are not suitable for managing the risks associated with consumer use,” continues the Ministry for Ecological Transition.

UV filters in news
In the same month that the consultation opened, a study by Aaron Boyd, a Ph.D. candidate at the University of Alberta, revealed that environmental contamination by octocrylene may be less detrimental to wildlife than previously thought.

“Researchers overwhelmingly perform studies testing the toxicity of UVFs in isolation by exposing test organisms to one chemical at a time,” says Boyd. “In fact, less than 3% of aquatic toxicology studies published to date have investigated whole sunscreen mixtures, leaving a massive knowledge gap to be addressed.”

“We found that Daphnia could survive long-term exposure to sunscreens containing octocrylene at concentrations >50 times higher than what would be completely lethal to all water fleas had they been exposed to the UVF alone.”

Meanwhile, the Australian manufacturer of natural sunscreen actives, Advance ZincTek, released EcoZinc, a non-nano zinc oxide powder for reef-safe SPF-rated cosmetics and sunscreens, and Korean original design manufacturer Cosmax introduced Capsule Sun, an emulsifier-free sunscreen formula.

By Venya Patel

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