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Public Health (31-07-2012)

SCCS final opinion on Fragrance allergens in cosmetic products now available

Brussels , 31 July 2012

The Commission published today an opinion by the Scientific Committee on Consumer Safety (SCCS) on fragrance allergens in cosmetic products. The opinion identifies potentially allergenic fragrance ingredients and suggests concentration limits for some of them to protect consumers from allergies.

Allergy to fragrance ingredients is estimated to affect 1 to 3% of the European population and can significantly impair quality of life. In 1999, the European Scientific Committee SCCNFP1 identified 26 fragrance allergens. Consequently, measures were introduced in the Cosmetics Directive 76/768/EEC that require manufacturers to list these ingredients individually on the label of cosmetic products containing them, when they are present in the product above certain low concentrations. This allows doctors to diagnose allergies to fragrance ingredients more easily, and patients who know the cause of their allergy are able to avoid cosmetics that will cause reactions.

Since 1999, much more information on fragrance allergens has become available. Therefore the European Commission requested the SCCS to review the current knowledge and to check whether the list of fragrance allergens relevant for consumers needed to be modified and whether safe limits could be established for the most frequent allergens.

In its opinion, the SCCS identifies fragrance ingredients which are established contact allergens in humans, based on results from human clinical and epidemiological evidence. This includes the 26 ingredients already identified by the SCCNFP, an additional 30 individual chemicals and 26 natural extracts.

The SCCS's list also features fragrance allergens likely to cause allergies in humans, as identified on the basis of evidence from animal studies and analysis of chemical structures.

Furthermore, chemical processes which can transform seemingly innocuous fragrance chemicals into allergens were also scrutinised by SCCS and the present state of knowledge is presented in the opinion.

Concentration limits

With regard to fragrance allergens reported to cause a high number of allergy cases, the SCCS derived a concentration limit expected to protect most patients from allergies to these ingredients, or from reacting to the cosmetics which contain them. The SCCS also considers that this concentration limit is appropriate to prevent non-allergic consumers from developing allergy to these fragrance ingredients.

The final opinion adopted in this plenary was prepared following stakeholder input during a public consultation with 112 contributions and a public hearing on the draft opinion.

What next

Based on the SCCS opinion, the Commission will consider the appropriate regulatory measures.

SCCS is an independent advisory body established to advise the Commission on issues associated with consumer safety. Its members are chosen on the basis of their scientific excellence.

Read the full opinion on Fragrance allergens in cosmetic products:
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_102.pdf

The European Scientific Committee on Cosmetic Products and Non-food products intended for Consumers (SCCNFP), a predecessor of the current Scientific Committee on Consumer Safety (SCCS)