EU - SCCS Fragrance Allergens
EU Scientific Committee on Consumer Safety - Fragrance Allergens
Depending on the quality of the available information and the strength of the evidence, dermatologists and other scientists distinguish between established (in humans or animals), likely, or possible contact allergens. In their evaluations, they consider information available on the fragrance substance from human studies (for example clinical or epidemiological studies), data from experimental animal studies or chemical structure information that, based on historical experience with similar type of chemicals, suggest the potential of a fragrance substance to cause skin allergies.
Following their review and data evaluation, the Scientific Committee on Consumer Safety identified a total of 54 individual fragrance substances and 28 natural extracts (essential oils) as ‘established contact allergens in humans’. The scientific committee also considered 18 individual chemicals and 1 natural extract as ‘established contact allergens in animals’, 26 individual chemicals categorised as ‘likely contact allergens’ and 35 individual chemicals plus 13 natural extracts categorised as ‘possible contact allergens’.
In 1999, a set of 26 fragrance allergens with a well-recognised potential to cause allergy had been ifentified, for which information should be provided to consumers about their presence in cosmetic products.
On this basis, the Cosmetics directive required that the presence any of these 26 substances be indicated in the list of ingredients when its concentration exceeds 0,001 % in leave-on products and 0,01 % in rinse-off products. These limits had been set in a pragmatic administrative decision in the absence of known thresholds for these allergens.
Such labelling allows patients who are allergic to one or more of these 26 fragrance chemicals to avoid products containing them.
The Scientific Committee on Consumer Safety now identified more than 100 additional individual substances and natural extracts as established contact allergens or likely contact allergens by combination of evidence. In its conclusions, the scientific committee recommends that the consumer be made aware of the presence of all known and likely fragrance allergens in cosmetic products and not only the 26 currently listed.
More recently, The European Commission has published the Regulation (EU) 2017/1410, banning the use of three fragrance allergens, HICC (CAS NO. 51414-25-6/ 31906-04-4), atranol (CAS NO. 526-37-4) and chloroatranol (CAS NO. 57074-21-2).
http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1502329423429&uri=CELEX:32017R1410