Science Committee Greenlights CMR for Use in Cosmetics

The Scientific Committee on Consumer Safety (SCCS) has said the preservative polyaminopropyl biguanide (PHMB) is safe for use at a concentration of 0.1%, in its first opinion on the use of a carcinogenic, mutagenic and reprotoxic (CMR) substance in cosmetics, since the European Commission confirmed they are not automatically banned under the cosmetics Regulation.

The Commission confirmed its policy last September, saying a ban on a CMR in cosmetics must be implemented by a specific act amending the Regulation's relevant annexes. Its decision was criticised by Denmark, which says this should be automatic.

Two years ago, the Commission asked the committee if PHMB – a category 2 CMR – was safe at levels up to 0.3%. It ruled that this was not the case but that safe use could be based on a lower use concentration or restrictions.

The committee's latest opinion – out for consultation until 10 March – says that based on new dermal absorption studies on additional cosmetic formulations, its use is safe at levels up to 0.1%.

Cosmetics Europe said it was pleased with the conclusion, but director general John Chave said the"shrinking pallette" of cosmetics preservatives remains an “ongoing concern”.

The committee's opinion indicates that an assessment approach based on substance risk – rather than hazard – is taking precedence under the cosmetics Regulation, said Mr Chave. “This points to the fact that an automatic ban under the old [Commission] interpretation would have been disproportionate.”

But the Danish Environmental Protection Agency (EPA) says that although it supports the opinions drafted by the SCCS, it still disagrees with the Commission’s new interpretation on CMR substances in cosmetics.

Denmark wants the cosmetics Regulation interpreted as saying that substances with mandatory CMR classifications under the CLP Regulation should be automatically banned. In a letter sent to the Commission in November, the country’s food and environment minister said the its new policy reduces consumer safety.

"If the conclusion in the latest opinion on PHMB from the SCCS is maintained after the commenting period, we expect the Commission to draft a new proposal on the regulation on PHMB," an EPA spokesperson said.

HEPB opinion

The committee also issued an opinion on the cosmetic preservative hydroxyethoxyphenyl butanone (HEPB) – again out for consultation until 10 March. It says its use in rinse-off, oral care and leave-on products is not safe at levels above 2.0%. But it said the preservative could be considered safe if “more reliable and supporting data” on its in vitro dermal penetration was provided.