Contact allergy to
fragrance substances is an
important clinical problem. Up
to 10% of individuals with
eczema are allergic to
fragrance substances and
possibly 1-2% of the general
population.
In response to questions
from a Member State and from
the European Parliament, the
SCCNFP has been asked on 23
February 1998 by DG III -
Industry to respond to the
following mandate in relation
to the safety of fragrance
ingredients :
* Does the SCCNFP agree
to the inclusion of all IFRA
restricted materials into Annex
III (List of substances which
cosmetic products must not
contain except subject to
restrictions and conditions
laid down)? Are the permitted
usage levels recommended by
IFRA suitable for use in the
Cosmetics Directive 76/768/EEC?
* Does the SCCNFP agree
that all materials that IFRA
recommend should not be used as
fragrance compounds are
included in Annex II ( List of
substances which must not form
part of the composition of
cosmetic products)?
* It is proposed that
all known fragrance allergens
are labelled on cosmetics if
used in the product. Does the
SCCNFP agree to this proposal?
If so
Which chemicals fall
under this classification?
Is there a maximum
concentration of each chemical
permissible without the
requirement for labelling?
* Restrictions are
proposed for the 3 most common
fragrance allergens ( cinnamic
aldehyde, isoeugenol,
hydroxycitronellal). Does the
SCCNFP agree to restriction on
the use of common fragrance
allergens (Annex III listing)?
If so
Which fragrance
materials should be subject to
restrictions?
What are the conditions
for restrictions (maximum
concentration, fields of
application etc.)?
The SCCNFP considers
that this mandate can be
usefully divided into the two
sections:
Identification of those
fragrance ingredients which are
of concern as allergens for the
consumer. Recommendations on
informing the consumer of the
presence of important allergens
to permit the consumer with a
known fragrance allergy a means
to avoid contact with an
allergen. An opinion as to
whether such identification can
be related to concentrations
present in a product when
elicitation levels are known.
An opinion on the
adoption of industry prohibited
substances into Annex 2 and
adoption of industry restricted
substances into Annex 3.
Consideration as to whether the
concentration limits or other
restrictions suggested by
industry can be supported or
need to be changed if there is
such inclusion in Annex 3.
Whether there are additional
substances which should be
subject to inclusion in an
Annex.
Taking into account the
importance and enormity of the
mandate, the first section will
be considered initially.
A critical review of the
problem of fragrance allergy in
the consumer.
Identification of those
fragrance allergens (of known
composition) which are well
recognised as consumer
allergens; a strict criteria
for such identification will be
followed.
Because of the absence
or paucity of data on dose
elicitation thresholds it may
not be possible to provide
opinions on concentrations of
allergens which may be safe.
Allergy to natural
compositions will be analysed
separately.
The SCCNFP opinions on
the above are in progress and
will be presented in September
1999 for formal adoption. This
will be the first part of an
overall response to the
mandate.