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SCCS/1459/11
Scientific Committee on Consumer Safety
SCCS
OPINION
on
Fragrance allergens in cosmetic products
th
The SCCS adopted this pre-consultation opinion at its 13 plenary meeting
of 13-14 December 2011
SCCS/1459/11
Opinion on fragrance allergens in cosmetic products
_________________________________________________________________________________________
About the Scientific Committees
Three 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 and Environmental Risks (SCHER) and the Scientific Committee on Emerging and
Newly Identified Health Risks (SCENIHR) and are made up of external 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 all types of 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
Jürgen Angerer, Ulrike Bernauer, Claire Chambers, Qasim Chaudhry, Gisela Degen, Elsa
Nielsen, Thomas Platzek, Suresh Chandra Rastogi, Vera Rogiers, Christophe Rousselle, Tore
Sanner, Jan van Benthem, Jacqueline van Engelen, Maria Pilar Vinardell, Rosemary Waring,
Ian R. White
Contact
European Commission
Health & Consumers
Directorate D: Health Systems and Products
Unit D5 - Risk Assessment
Office: B232 B-1049 Brussels
Sanco-SCCS-Secretariat@ec.europa.eu
© European Union, 2011
ISSN 1831- ISBN 978-92-79-
Doi:10.2773/ 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
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SCCS/1459/11
Opinion on fragrance allergens in cosmetic products
_________________________________________________________________________________________
Acknowledgements
Dr. C. Chambers
Dr. Q. Chaudry
Dr. S.C. Rastogi
Dr. I.R. White (chairman)
External experts
Dr. A. Börje University of Gothenburg, Sweden
Prof. J. D. Johansen Gentofte Hospital, University of Copenhagen, Denmark
Prof. A-T. Karlberg University of Gothenburg, Sweden
Prof. C. Lidén Karolinska Institute, Sweden
Dr. D.W. Roberts Liverpool John Moores University, UK
Prof. W. Uter (rapporteur) Friedrich-Alexander University (FAU), Erlangen,
Germany
Keywords: SCCS, scientific opinion, labelling, fragrance allergens, directive 76/768/ECC
Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), opinion on
fragrance allergens in cosmetic products, 13-14 December 2011
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SCCS/1459/11
Opinion on fragrance allergens in cosmetic products
_________________________________________________________________________________________
Table of contents
Acknowledgements...................................................................................................3
Table of contents .....................................................................................................4
Summary................................................................................................................7
1. Background......................................................................................................9
2. Terms of reference........................................................................................... 10
3. Introduction.................................................................................................... 11
4. Clinical aspects of contact allergy to fragrance ingredients.....................................12
4.1. Spectrum of reactions.............................................................................. 12
4.1.1. Allergic contact dermatitis .................................................................. 12
4.1.2. Irritant reactions (including contact urticaria)........................................14
4.1.3. Pigmentary anomalies........................................................................ 14
4.1.4. Photo-reactions................................................................................. 14
4.1.5. General/respiratory ........................................................................... 14
4.2. Epidemiology of fragrance allergy..............................................................15
4.2.1. Substances used for screening of contact allergy to fragrance ingredients .15
4.2.2. Clinical epidemiology ......................................................................... 16
4.2.3. Population-based epidemiology ...........................................................22
4.3. Consumer products as a cause of fragrance contact sensitisation and allergic
contact dermatitis............................................................................................... 24
4.3.1. Clinical relevance .............................................................................. 24
4.3.2. Elicitation with clinical symptoms/signs, current and past........................24
4.3.3. Elicitation in diagnostic patch tests without clinical history.......................27
4.4. Socio-economic impact of contact allergy....................................................28
4.4.1. Health related quality of life................................................................ 28
4.4.2. Occupational restrictions.................................................................... 28
4.4.3. Costs to health care/health economics .................................................28
4.5. Allergen avoidance.................................................................................. 29
4.5.1. Primary prevention: limiting or eliminating exposure to allergens in the
population 29
4.5.2. Secondary prevention: avoiding re-exposure to (a) specific sensitiser(s) in
clinically diagnosed individuals........................................................................... 29
4.6. Conclusions............................................................................................ 31
5. Activation of weak or non-sensitising substances into sensitisers - prehaptens and
prohaptens............................................................................................................ 32
5.1. Prehaptens............................................................................................. 32
5.2. Prohaptens............................................................................................. 36
5.3. Conclusions............................................................................................ 37
6. Retrieval of evidence and classification of fragrance substances..............................39
6.1. Retrieval of evidence ............................................................................... 39
6.1.1. Search strategy for clinical data .......................................................... 39
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