SCCS releases a final opinion on Allergy Alert Test (AAT)

On 10 September 2019, the SCCS adopted the final opinion on Allergy Alert Test (AAT) as a proof-of-concept study.

This opinion was developed using the final Report for a study aimed to evaluate whether an Allergy Alert Test (AAT) would be an appropriate “self-test” (to be performed by consumers) to indicate a consumer’s allergic reaction to an ingredient in a hair dye product.

The test induces a self-noticeable alert signal, which indicates the presence of an allergic reaction. According to the SCCS, the test may lead to false-negative AAT reactions in sensitised consumers, who may then develop allergic contact dermatitis to a product applied posteriorly.

Furthermore, even though the study shows a well-informed layperson can perform self-evaluations matching inaccuracy to a dermatology experts’ assessment, the SCCS still questions the general applicability of the test, given there is a possibility that the study participants belong to a more educated or motivated subset of the general user population.

Taking these aspects into consideration, at this stage, the SCCS cannot endorse the AAT as an “alert” for contact allergy to hair dyes in consumers.

Finally, the SCCS reiterated an aspect already expressed in a previous opinion, adopted on 18 December 2007, that the Cosmetics Regulation does not cover the use of hair dye products on the skin within vitro diagnostic purposes, thus advising the consideration of other screening methods for hair dye sensitisation. In the December 2007 opinion, concerns had also been raised regarding these “self-tests” relating to their safety and accuracy.


Ana Rita Falcao

RA Department

04/12/2019


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