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.