Allergy Alert Test (AAT) as a proof-of-concept study

SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
SCCS external experts: A. Koutsodimou, A. Simonnard, W. Uter (Rapporteur)
Contact: SANTE-C2-SCCSec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1607/19
Adopted on: 10 September 2019

Conclusion of the opinion:

1. In light of the study provided and the SCCP/1104/07 opinion, does the SCCS consider the new harmonized Allergy Alert Test (AAT), with the conditions listed above, a suitable test to provide a signal indicative of an allergic reaction to hair dyes when used by laypersons?

The SCCS acknowledges the standardisation of the allergy test offered by the proposed AAT as a prerequisite for possible future use of such a test by consumers. Within the precision limits of the study, it has been demonstrated that the rating of the test results by a well-informed layperson corresponds well with that of a dermatology expert. However, as the study participants may have constituted a selective, more educated, or motivated subset of the general user population, the effectiveness of the test in terms of general applicability to all consumers still needs to be demonstrated.

The diagnostic performance indicates a very good specificity, but a potentially moderate sensitivity, leaving room for the possibility of false-negative AAT reactions in sensitised consumers who may then experience allergic contact dermatitis to a subsequently applied product.

In addition, the results provided by the study can only partly enable assessment of the benefit and risk of the AAT for the consumers, and the SCCS cannot, at this stage, endorse the use of the AAT as an “alert” for contact allergy to hair dyes in consumers.

2. Does the SCCS have any further scientific concerns regarding the AAT?

The SCCS reiterates the concern expressed in the previous Opinion (SCCP/1104/07) that the AAT carries the same basic risk of sensitisation as the use of a hair dye product by a consumer. If the AAT is used on a regular basis before hair dyeing, it will inevitably increase the number of exposures, and this may increase the risk of sensitisation.

The SCCS would also like to reiterate from the previous Opinion SCCP/1104/07 to point out that the use of hair dye products on the skin and for in vivo diagnostic purposes is not covered by the Cosmetics Regulation. In this regard, the development and scientific evaluation of other screening methods for hair dye sensitisation (e.g. through a suitable, validated questionnaire) should be considered.

Keywords:

SCCS, scientific opinion, Allergy Alert Test, AAT, proof-of-concept study, Regulation 1223/2009, SCCS/1607/19

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on Allergy Alert Test (AAT) as a proof-of-concept study, preliminary version of 10 May 2019, final version of 10 September 2019, SCCS/1607/19.