The SCCS opinion states:
As a result of the public consultation on perfumery materials, which ended on 27 January 2007, there were further requests and information on important and/or frequently used allergens other than those proposed for regulation, such as farnesol, citral, linalool and hydroxyisohexyl-3-cyclohexenecarboxaldehyde. These substances were not part of the consultation, but they all belong to the 26 fragrance substances which should be labelled when present in cosmetic products under certain conditions. The 26 fragrance substances were introduced into annex III of the Cosmetics Directive by the 7th amendment (2003/15/EC) on the basis of the SCCNFP draft opinion (SCCNFP/0017/98) published on 30 September 1999 for public consultation and the final opinion adopted by the SCCNFP during the plenary session of 8 December 1999. Thirteen of the allergenic fragrance substances listed in this opinion have been frequently reported as well-recognised contact allergens in consumers and are thus of most concern; 11 others are less well documented. See the lists below from the opinion.
List A: Fragrance chemicals, which according to existing knowledge, are most frequently reported and well-recognised consumer allergens.
List B: Fragrance chemicals, which are less frequently reported and thus less documented as consumer allergens.
Methyl heptine carbonate
Furthermore, two fragrances (natural mixtures) were added
At the time there were insufficient scientific data to allow for the determination of dose- response relationships and/or thresholds for these allergens. Nevertheless, in a pragmatic administrative decision the limits of 0.01 and 0.001% were set, for rinse-off and leave-on products respectively. Scientific information of both a general and a specific nature has been submitted to DG ENTR in order to ask the SCCS for a revision of the 26 fragrances with respect to further restrictions and possible even delisting.
2. Terms of reference
1. Does the SCCS still consider that the fragrance allergens currently listed in Annex III, entries 67-92, for labelling purposes represent those fragrance ingredients that the consumer needs to be made aware of when present in cosmetic products? 2. Can the SCCS establish any threshold for their safe use based on the available scientific data? 3. Can the SCCS identify substances where processes (e.g. metabolism, oxidation and hydrolysis) may lead to cross-reactivity and new allergens which are relevant for the protection of the consumer?
3. Introduction Fragrance ingredients
Fragrance and flavour substances are organic compounds with characteristic, usually pleasant, odours. They are ubiquitously used in perfumes and other perfumed cosmetic products, but also in detergents, fabric softeners, and other household products where fragrance may be used to mask unpleasant odours from raw materials. Flavourings are used in foods, beverages, and dental products. Fragrance substances are also used in aromatherapy and may be present in herbal products, and used as topical medicaments for their antiseptic properties.
Contact allergy to fragrance ingredients occurs when an individual has been exposed, on the skin, to a sufficient degree of fragrance contact allergens. Contact allergy is a life-long, specifically altered reactivity in the immune system. This means that once contact allergy is developed, cells in the immune system will be present which can recognise and react towards the allergen. As a consequence, symptoms, i.e. allergic contact dermatitis, may occur upon re-exposure to the fragrance allergen(s) in question. Allergic contact dermatitis is an inflammatory skin disease characterised by erythema, swelling and vesicles in the acute phase. If exposure continues it may develop into a chronic condition with scaling and painful fissures of the skin. Allergic contact dermatitis to fragrance ingredients is most often caused by cosmetic products and usually involves the face and/or hands. It may affect fitness for work and the quality of life of the individual.
Fragrance contact allergy has long been recognised as a frequent and potentially disabling problem. Prevention is possible as it is an environmental disease and if the environment is modified (e.g. by reduced use concentrations of allergens), the disease frequency and severity will decrease. Ingredient information is a cornerstone in the prevention of allergic contact dermatitis, as knowledge about the allergens which a patient has been exposed to is crucial for including the right substances in the allergy test, and for subsequent information on avoidance of re-exposure. However, the labelling rules in the Cosmetics Directive 76/768/EEC stipulated that perfume and aromatic compositions and their raw materials shall be referred to by the word “perfume” or “aroma”, rather than being labelled individually. This is the reason why the SCCNFP in their opinion SCCNFP/0017/98 (1) identified 26 fragrance allergens for which information should be provided to consumers concerning their presence in cosmetic products. This was implemented in the Cosmetics Directive as individual ingredient labelling of the 26 fragrance allergens (Annex III, entries 67-92). However, safe use concentrations of these fragrances in cosmetic products had not yet been determined and much new evidence concerning fragrance allergy has been published since the 1999 opinion. The present request to review the list of recognised fragrance allergens which the consumer needs to be made aware of, to indicate thresholds for their safe use and to consider possible modification of allergens by metabolism and autoxidation, required a thorough review of all relevant scientific data. This includes both published scientific literature as well as unpublished scientific information on fragrances from the industry. The International Fragrance Association (IFRA), as representative of the fragrance industry, was contacted to provide relevant unpublished scientific data on fragrance ingredients. This information, together with the up-to-date published scientific literature, has been critically reviewed for the present SCCS opinion. The relevant data gaps are identified and recommendations for research addressing these gaps are made.
Source & ©: SCCS,
26-27 June 2012, 1. Background, 2. Terms of reference, 3. Introduction. p.9-11