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Directorate-General for Health and Food Safety
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.
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.
