Terms of Reference

1. Cosmetic products marketed in the EU may only contain those preservatives which are listed in Annex VI of the Cosmetics Directive 76/768/EEC, "List of preservatives which cosmetic products may contain".

The preamble of the Annex states that preservatives marked with the symbol (+) may also be added to cosmetic products in concentrations other than those laid down in the Annex for other specific purposes apparent from the presentation of the products.

In practice, these substances can be used in cosmetics at much higher concentrations, as long as they are not employed as preservatives.

2. There are seven substances listed in Annex VI that bear the symbol (+) for which requirements concerning "limitations and requirements" and "conditions for use and warnings which must be printed on the label" are specified.

The affected substances are :

n° 3. salicylic acid and its salts

n° 5. formaldehyde and paraformaldehyde

n° 8. pyrithione zinc

n° 21. bronopol

n° 23. triclocarban

n° 24. 4-chloro-m-cresol

n° 35. 1-hydroxy-4-methyl-6(2,4,4-trimethylpentyl)2-pyridon and its monoethanolamine salt

Mandate

The SCCNFP has been asked for its opinion as to whether the requirements on limitation and labelling are valid when these chemicals are used in cosmetics for purposes other than for a preservative function.

Opinion

The toxicological effects of the substances tabulated will be the same for all potential uses of them; a higher exposure as permitted by "other uses" could reasonably be expected to lead to increased toxicological hazard.

Therefore, it is the opinion of the SCCNFP that those substances indicated by (+) in Annex VI, when incorporated into cosmetic formulations for non-preservative functions, should be subjected to the same restrictions in usage levels and warnings as when used for preservative effect.