SCCP opposes dermal sensitisation test

The EU scientific committee on consumer products is opposing the use of a dermal sensitisation quantitative risk assessment (QRA) for testing potential allergic reactions in fragrances and other cosmetics. Following detailed assessments of whether the test method is suitable to assess fragrances citral, farnesol and phenylacetaldehyde, the committee concluded: “There is no confidence that the levels of skin sensitisers identified by the dermal sensitisation QRA are safe for the consumer.” The model mainly uses industry data from experimental sensitisation tests in humans, about which the committee warns there is a “lack of in-depth method description and the experience”.

It added that identification of safe levels of exposure to existing known skin-allergens “should be based on clinical data and/or elicitation low effect levels”, which are the only existing reliable methods.

Meanwhile, in other recent opinions, the committee has restated its opposition to the use of 2-amino-4-hydroxyethylamino-anisole and its sulfate as a hair dye “and should not be present in hair dyes or other cosmetic products”.

It has also opposed the use of vitamin K1 in cosmetic products as “not safe, since it may cause cutaneous allergy”. This would prevent affected consumers from taking K1 orally and so they would be “denied an important therapeutic agent”, said the committee.