WRITTEN QUESTION P-2939/02

by Chris Davies (ELDR) to the Commission

(10 October 2002)

Subject: Future of aromatherapy

Aromatherapists have voiced concerns that proposals to label fragrance allergens as laid out in the cosmetics directive 76/768/EEC(1) do not distinguish between synthetic and natural compounds, which will have serious consequences for their profession.

Further to the Commission reply of 24.9.2002 to Written Question E- 2126/02(2), aromatherapists respond by stating that tests carried out with synthetic versions of natural substances often have minor impurities. These may prove to be the allergens and not the materials themselves. Further it is quite likely that alleged sensitivity effects arise not from the suspected fragrance allergens themselves (pure limonene, pure linalol etc.) but from minor amounts of oxidation products which inevitably accompany these somewhat unstable compounds. It is already known that oxidised limonene, alpha-pinene and oxidised delta-3-carene cause skin sensitivity problems. Limonene is one of the 26 suspected allergens. In their pure state, and when antioxidant is added, some at least of these materials may not be sensitisers, and this factor has not been eliminated from the experimental data.

Natural compounds occurring in essential oils may have been prevented from oxidising by virtue of other natural components present e.g. furanocoumarins. There is often no such buffering system present with mixtures of synthetic compounds. Many natural compounds may be present largely as one specific geometrical isomer or enantiomeric isomer. Again it is not uncommon to find that certain natural compounds may occur on two, four or more isomers. Synthetic compounds are often racemic (i.e. a 50-50 mix of enantiomeric isomers) or have differing isomeric distributions. It is not proven in the scientific literature that these different isomeric forms have the same allergenicity. One form may for example be devoid of any allergenic effects.

Has the SCCNFP taken these points into account when reaching its conclusions?

(1) OJ L 262, 27.9.1976, p. 169.

(2) OJ C 28 E, 6.2.2003, p. 190.

Answer given by Mr Byrne on behalf of the Commission

(31 October 2002)

The opinion of the Scientific Committee on Cosmetic Products and Non-Food Products intended for consumers (SCCNFP) of 8 December 1999 concerning the fragrance allergy in consumers is based on and supported by an extensive number of studies, published in leading scientific journals. None of these studies indicate a difference in allergenicity between a fragrance ingredient synthetically produced or extracted from a natural product. An important problem with fragrance substances of natural origin is the difficulty of quality control. There may be considerable variation in the content of toxic/sensitising chemicals; oakmoss is an example. There is no demonstration in the peer reviewed scientific literature that fragrances compounds of natural origin are safer than synthetic ones.

The Commission is aware that oxidation products and isomers may affect the allergenic potential of certain fragrance ingredients, both of synthetic and natural origin.

The issue of oxidation products and, as relevant, of isomers has been considered by the SCCNFP, e.g. d-limonene and its ability to form allergenic oxidation products. No restriction has been proposed on its other isomers, namely l- and dl-limonene.

Also, the International Fragrance Association (IFRA) recommends that d-, l- and dl-limonene and natural products containing amounts of it, should only be used when the level of peroxides is kept to the lowest practical level, for instance by adding anti-oxidants at the time of production.