France moves closer to blocking popular sunscreen ingredient octocrylene

21 Nov 2023 --- European regulatory watchdog agencies are building up a science-backed case to ban the use of octocrylene, a widely-used skin care and sunblock ingredient. Currently flagged as a potential endocrine disruptor, it is under heightened scrutiny by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES), which may see octocrylene lifted from local commercial products soon. 

Octocrylene is also known as octocrilene, 2-ethylhexyl 2-cyano-3 and 3-diphenylacrylate. The ingredient is particularly suitable for water-resistant formulations, making it ideal in sunscreen formulas, as it is hydrophobic and miscible with many emollients.

“We are currently hosting a call for evidence through our website on behalf of France so that it gains more information to prepare its proposal to restrict octocrylene,” a spokesperson of the European Chemicals Agency (ECHA) tells Personal Care Insights.

“After submission, the proposal will be evaluated by ECHA’s scientific committees for risk assessment and socio-economic analysis. Those opinions will be sent with the proposal to the European Commission.”

Octocrylene was lagged for its tendency to be systemically absorbed into the body after one use.Dominance in the sunscreen market
Octocrylene is currently used in a wide range of cosmetic products to provide an appropriate SPF value in sunscreens or protect cosmetics against UV radiation. It is approved for use in sun care preparations in many countries with maximum levels of 10% in Europe and America and 12% in Canada.

In 2021, the US FDA, which also governs sunscreen safety, found that only two ingredients, zinc oxide and titanium dioxide, could be classified as safe and effective based on available information. 

Twelve other ingredients including octocrylene were proposed as “not generally recognized as safe and effective due to insufficient data.” Octocrylene was lagged for its tendency to be systemically absorbed into the body after one use. It is often contaminated with benzophenone, which is known to cause cancer. According to one study, benzophenones levels can increase in products over time. 

As highlighted by the Environmental Working Group (EWG), the UV filter is also absorbable through the skin at levels about 14 times the FDA cutoff limit for systemic exposure but the FDA suggests there is not enough data to determine whether it can be classified as safe and effective.

Octocrylene is also linked to aquatic toxicity, with the potential to harm coral health, as stressed by the EWG.

However, there have been contradictory bodies of evidence surrounding the measurable environmental impact of octocrylene. For instance, one study by Aaron Boyd, a Ph.D. candidate at the University of Alberta, Canada, revealed that environmental contamination by octocrylene may be less detrimental to wildlife than previously thought.

European regulators seek safety evidence
On November 15, 2023, ECHA launched a call for contributed scientific evidence to assess the safety of octocrylene. This consultation is now open until January 10, 2024.

This call for evidence aims to collect information about the manufacture, import, use and placing on the market of octocrylene as well as feasibility for its substitution with potential alternatives. 

Octocrylene is also linked to aquatic toxicity, with the potential to harm coral health, as stressed by the EWG.

Regulators also aim to assess the socio-economic impacts of restricting uses of the substance under REACH Regulation on the registration, evaluation, authorization and restriction of chemicals.

In September, France’s ANSES performed a RMOA to determine if regulatory risk management action is needed at a broader EU level for octocrylene. 

The French regulatory body decided the best way to manage risks associated with octocrylene would be to create a REACH “restriction dossier” to address any environmental risks not adequately controlled.

France is currently preparing a technical document for the ECHA in October 2024 to formally propose the restriction on octocrylene.

The information received will be used for the preparation of the Annex XV (REACH) restriction file that the French agency is preparing. This consultation is open until January 10, 2024.

Amid these discussions, product launches of “reef safe” options are growing. Advance ZincTek recently released a non-nano zinc oxide powder designed for reef-safe SPF-rated cosmetics and sunscreens.

Meanwhile, Reef Relief introduced a product that “goes further” than other sunscreens to not only protect coral reefs but also “feed and enrich” aquatic ecosystems.

By Benjamin Ferrer