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Opinion on Allergy Alert Test (AAT) As a Proof-Of-Concept Study ______ SCCS/1607/19 Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON Allergy Alert Test (AAT) as a proof-of-concept study The SCCS adopted the final Opinion by written procedure on 10 September 2019 SCCS/1607/19 Final Opinion Opinion on Allergy Alert Test (AAT) as a proof-of-concept study _________________________________________________________________________________________________________________ ACKNOWLEDGMENTS SCCS members listed below are acknowledged for their valuable contribution to the finalisation of this Opinion. For the preliminary and the final versions SCCS members Dr U. Bernauer Dr L. Bodin Prof. Q. Chaudhry (SCCS Chair) Prof. M. Dusinska Dr J. Ezendam Dr E. Gaffet Prof. C. L. Galli Dr B. Granum Prof. E. Panteri Prof. V. Rogiers (SCCS Vice-Chair) Dr Ch. Rousselle Dr M. Stepnik Prof. T. Vanhaecke Dr S. Wijnhoven SCCS external experts Dr A. Koutsodimou Dr A. Simonnard Prof. W. Uter (Rapporteur) All Declarations of Working Group members are available on the following webpage: http://ec.europa.eu/health/scientific_committees/experts/declarations/sccs_en.htm This Opinion has been subject to a commenting period of a minimum eight weeks after its initial publication (from 13 May 2019 until 12 July 2019). Comments received during this time period were considered by the SCCS. For this Opinion, comments received resulted in the following main changes: SCCS comments in sections 3.2.4, 3.3.2.1. and 3.3.2.5. These changes are not impacting the discussion and conclusion parts that remain unchanged. 2 SCCS/1607/19 Final Opinion Opinion on Allergy Alert Test (AAT) as a proof-of-concept study _________________________________________________________________________________________________________________ 1. ABSTRACT The SCCS concludes the following: (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 3 SCCS/1607/19 Final Opinion Opinion on Allergy Alert Test (AAT) as a proof-of-concept study _________________________________________________________________________________________________________________ About the Scientific Committees Two independent non-food Scientific Committees provide the Commission with the scientific advice it needs when preparing policy and proposals relating to consumer safety, public health and the environment. The Committees also draw the Commission's attention to the new or emerging problems which may pose an actual or potential threat. They are: the Scientific Committee on Consumer Safety (SCCS), the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) and are made up of independent experts. In addition, the Commission relies upon the work of the European Food Safety Authority (EFSA), the European Medicines Agency (EMA), the European Centre for Disease prevention and Control (ECDC) and the European Chemicals Agency (ECHA). SCCS The Committee shall provide Opinions on questions concerning health and safety risks (notably chemical, biological, mechanical and other physical risks) of non-food consumer products (for example cosmetic products and their ingredients, toys, textiles, clothing, personal care and household products such as detergents, etc.) and services (for example: tattooing, artificial sun tanning, etc.). Scientific Committee members Bernauer Ulrike, Bodin Laurent, Chaudhry Qasim, Coenraads Pieter-Jan*, Dusinska Maria, Ezendam Janine, Gaffet Eric, Galli Corrado Lodovico, Granum Berit, Panteri Eirini, Rogiers Vera, Rousselle Christophe, Stępnik Maciej, Vanhaecke Tamara, Wijnhoven Susan * CPJ did not take part in any scientific discussion and in voting. Contact: European Commission Health and Food Safety Directorate C: Public Health, country knowledge and crisis management Unit C2 – Country knowledge and Scientific Committees Office: HTC 03/073 L-2920 Luxembourg [email protected] © European Union, 2019 ISSN ISBN Doi ND The opinions of the Scientific Committees present the views of the independent scientists who are members of the committees. They do not necessarily reflect the views of the European Commission. The opinions are published by the European Commission in their original language only. http://ec.europa.eu/health/scientific_committees/consumer_safety/index_en.htm 4 SCCS/1607/19 Final Opinion Opinion on Allergy Alert Test (AAT) as a proof-of-concept study _________________________________________________________________________________________________________________ TABLE OF CONTENTS ACKNOWLEDGMENTS ........................................................................................... 2 1. ABSTRACT .................................................................................................. 3 2. MANDATE FROM THE EUROPEAN COMMISSION ................................................ 6 3. OPINION ..................................................................................................... 7 3.1 Scope and aim of AAT (Study Objectives) ................................................ 7 3.2 INVESTIGATIONAL PLAN (Methods) ........................................................ 8 3.2.1 Overall study design and plan ................................................... 8 3.2.2 Discussion of study design ..................................................... 10 3.2.3 Selection of study population .................................................. 11 3.2.4 Treatments .......................................................................... 11 3.2.5 Efficacy ............................................................................... 13 3.2.6 Safety ................................................................................. 14 3.2.7 STUDY SUBJECTS ................................................................. 14 3.3 EFFICACY EVALUATION (Results with AAT) ............................................ 15 3.3.1 Demographic and other baseline characteristics ........................ 15 3.3.2 Efficacy results ..................................................................... 16 3.3.3 Efficacy conclusions .............................................................. 22 3.4 SAFETY EVALUATION.......................................................................... 23 3.5 General Discussion ............................................................................. 24 4. CONCLUSION ............................................................................................ 26 5. MINORITY OPINION .................................................................................... 26 ANNEX: additional information ............................................................................. 27 6. REFERENCES ............................................................................................. 42 7. GLOSSARY OF TERMS ................................................................................. 42 8. LIST OF ABBREVIATIONS ............................................................................ 42 5 SCCS/1607/19 Final Opinion Opinion on Allergy Alert Test (AAT) as a proof-of-concept study _________________________________________________________________________________________________________________
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