WRITTEN QUESTION E-2126/02

by Chris Davies (ELDR) to the Commission

(17 July 2002)

Subject: Fragrance allergens

On 8 December 1999, the Scientific Committee on Cosmetic and Non-Food Products (SCCNFP) adopted an opinion on fragrance allergy compounds. It does not discriminate between synthetic and natural fragrance compounds.

A report in TNO Bibra Bulletin 2001, 40, 71 draws attention to the work of Orton D.I. and Shaw S. (2001) Contact Dermatitis 44, 190 who looked at the components of the standard diagnostic fragrance mix, used to determine if patients with allergic contact dermatitis have fragrance allergy. The authors found that positive reactions were caused in 14 patients between 1982 and 2000 to both the mix and to the sorbitan sesquioleate emulsifier used to disperse the odorants. The conclusion was that only two of the patients of the 14 identified could be considered sensitised to one of the odorants in the mix.

It may be that the other 12 reactions were caused by the sorbitan sesquioleate emulsifier rather than the fragrance mix.

This study, amongst others (Frosch PJ et al. 1995a and 1995b), appears to cast doubt on allegations elsewhere about problems associated with fragrance allergens.

Did the SCCNFP take this evidence into account when drawing up its opinion?

Will there be any further investigation into this issue, which is clearly not resolved in the SCCNFP opinion?

Answer given by Mr Byrne on behalf of the Commission

(24 September 2002)

As the SCCNFP issued its opinion on fragrance allergy in consumers on 8 December 1999, it did not consider the report in TNO Bibra Bulletin 2001. The Committee's opinion is supported by an extensive bibliography; in any case, the Commission will draw the Committee's attention to the TNO report.

In its opinion, the SCCNFP does not discriminate between synthetic and natural compounds as there is no difference in allergenicity between a chemical compound synthetically produced or extracted from a natural product.

The aim is that information should be provided to consumers about the known presence in cosmetic products of fragrance ingredients with a well-recognised potential to cause contact allergy. Information regarding these fragrance chemicals should be given to consumers if deliberately added to a fragrance formulation either in the form of a chemical or as an identified constituent of an ingredient.

A fragrance ingredient is defined by the International Fragrance Association (IFRA) as any basic substance used in the manufacture of fragrance materials for its odorous, odour-enhancing or blending properties. Fragrance ingredients may be obtained by chemical synthesis from synthetic, fossil or natural raw materials or by physical operations from natural sources.

Sorbitan sesquioleate is used as an emulsifier in the standard diagnostic fragrance mix. It is known to be a very rare allergen. Individuals shown to react to the fragrance mix will be tested to the individual eight fragrance components of the mix and also to the sorbitan sesquioleate. The individual tests do not require the emulsifier. There are papers showing that, sesquioleate is not an important factor. It was fully debated at least 10 years ago.

Therefore, the assumption that the other 12 reactions may have been caused by the sorbitan sesquioleate emulsifier rather than the fragrance mix is not relevant to the problem of fragrance allergy.