Brussels makes a conciliatory move over the ‘26 Allergens’ debacle

by Tony Burfield March 2009

Cropwatch has been campaigning for a number of years to change the situation regarding the 26 alleged allergens (16 of which occur in natural products) which carry a labeling obligation where the concentration of any one identified fragrance substances in the final cosmetic product is 0.01% or above for products rinsed off the skin, or 0.001% or above in leave-on products. This requirement was incorporated into Council Directive 2003/15/EC, whereby these materials were moved into Annex III of the Cosmetics Directive. The basis for the inclusion of these substances as allergens has never been explained by the SCCP (Storrs 2007).

Independent papers/peer-reviews/comments (e.g. Schnuch (2004),  Vocansen (2006 & 2007), and several by Hostynek & Maibach) have indicated that there is no robust clinical or experimental evidence to support many of these 26 ingredients as allergens. Up to now there has seemed to be no mechanism to independently review the SCCP’s Opinion, or undo Directive 2003/15/EC, although Schnuch (2008) had openly asked the EU to rethink their policy.

In a new move, a request for an updated scientific opinion on the labeling of 26 fragrance substances has been made by Brussels to the SCCP, apparently being described as a spin-off from the public consultation (Nov 2006) on the Commission proposal of regulation of some fragrance substances.

"Scientific information of general and specific nature has been submitted to DG ENTR in order to ask the SCCP for a revision of the 26 fragrances with respect to further restrictions and possible even delisting.“

“At that time there were not sufficient scientific data to allow for determination of dose response relationships and/or thresholds for these allergens.”

…And that’s presumably the nearest we will ever come to an apology from Brussels, for the imposition of over-precautionary and unnecessary legislature, which cost the industry millions of Euros in reformulation and labeling costs at the time, and presumably will again, with any new situation. The passage of the original legislation depressed the production of some essential oils worldwide for at least two years afterwards, reflecting their reduced usage in cosmetics. This arises from the fact that the large majority of essential oils, absolutes & resinoids contain several of the 26 named allergens, and cosmetic manufacturers wished to avoid excessive product labeling. The decline in the overall usage of essential oils in fragrances from this cause is still felt today.

What is needed now is an independent impact assessment, sponsored by DG-Environment, to find out the damage caused to industry, and especially to SME’s, over the whole 26 allergens legislatory debacle. Cropwatch identifies one of the problems as the chemophobic attitudes of some European governments, who have been led by the nose by career toxicologists, who have exaggerated the ingredient risks posed by allergens. This pressured situation has pushed the EU Cosmetics Commissioner into over-hasty legislation over this matter. What has been missing in this situation is a realistic overview and the application of common sense, and we can only hope that lessons have been learned In Brussels, before the aroma industry, or parts of it, are totally bankrupted.

References

Schnuch A. (2008) – remarks attributed to Schnuch by the trade media during the IFRA workshop on Allergy Prevalence in Fragrance Nov. 2008 e.g. by Montague-Jones in Cosmetics-Design Europe 18.11.2008

Storrs F.J. (2007) “Allergen of the year: fragrance.” Dermatitis 18(1),3-7 [linked version is a Medscape reprint]

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