The French Agency for the Medical Safety of Health Products (Afssaps) was given the task in 2009 of reassessing the risks associated with some substances in cosmetics products and suspected of reprotoxic effects or of disrupting the endocrine system.

Benzophenone-3 (or oxybenzone) [1] is one of the substances concerned by this reassessment, a substance most commonly used as a UV filter in sunscreen products, but which is also suspected of being an endocrine disruptor.

Oxybenzone or benzophenone-3

European regulations currently allow [2] the use of benzophenone-3 with a maximum concentration of 10% as a UV filter in cosmetic products. However, Afssaps recalls that the European Scientific Committee for Consumer Safety recommended in 2008 [3] for the threshold to be lowered to 6%, but that the Commission had still not mentioned this recommendation in texts.

After reviewing in vitro and in vivo available studies the Afssaps confirms that a restriction of use of benzophenone-3 at a maximum concentration level of 6% will ensure the safe use of cosmetic products by adults. However the agency stated that with this percentage, the safety margin calculated for children under ten years of age, was below 100, not enough for being sure of the products’ safety.

The Afssaps forwarded its findings to the European Commission to have the regulation on cosmetic products actually modified. In the meantime, the French agency recommends that manufacturers limit the incorporation of benzophenone-3 in cosmetics at a maximum concentration level of 6% for adult use as a UV filter (0.5% as a formula protector) and not to use it for children up to the age of ten at a concentration of 6%. Questioned by Premium Beauty News, the Afssaps specifies it “is the responsibility of the safety assessor to make sure that the safety margin is superior to 100 so it can be considered as safe for the consumer.