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| White Paper A New Method for the Determination of 57 Allergens in Cosmetic Products A GC-MSMS analytical approach for regulatory compliance and safer products Regulation n°1223/2009 governs the marketing of cosmetic products in Europe. It restricts the use of substances that may cause allergic reactions in a large number of consumers. The substances targeted are potential cosmetic allergens, identified by the Scientific Committee on Consumer Safety (SCCS). To allow the regulation of these substances, it is necessary to include them in the DIP, product information file, and on the product label (FIL), visible to consumers. There are currently 26 potential allergens (Table 1) listed in Annex III of the Cosmetics Regulation that must be mentioned on the product label in the list of ingredients and comply with the limits set according to the end use of the product: - if their concentration exceeds 0.001% in unrinsed products - if their concentration exceeds 0.01% in rinsed products What is contact allergy? Contact allergy involves a specific change in the reactivity of the immune system. Once contact allergy has developed, the cells of the immune system continue to recognize and react to the allergen. Therefore, symptoms such as allergic contact dermatitis may occur upon re-exposure to the allergen or allergens in the fragrance. Source: CSAS "Opinion on fragrance allergens in cosmetic products "1 Extension of the scope of allergen determination The Scientific Committee on Consumer Safety proposed in its 2012 opinion (SCCS/1459/11)1 that the consumer be informed of additional fragrance allergens in cosmetic products and confirmed that the 26 allergens already listed in Annex II were still of concern. Following this opinion of the SCCS, the European Commission published a public consultation in 20142 where it proposed to amend Annex III of the Cosmetics Regulation by including 61 additional contact allergens in addition to the 26 allergens already listed in Annex III. Currently, there is no published update to the list of potential allergens, however, the industry is preparing for changes that could be implemented in the coming weeks or months. If the expansion of the list is confirmed, cosmetic manufacturers will need to ensure that ingredients in products are properly identified and that labeling is revised to meet the latest expectations of the regulation. Of these 87 substances, more than a third (30) are natural extracts, such as citrus sinensis bark oil and lavandin officinalis oil. These are still difficult to analyze, but... |
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