The European commission has adopted several substances, which have been classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) to Regulation (EC) No 1223/2009.
Salicylic acid (2-hydroxy-benzoic acid) has been classified as a CMR substance of category 2 but it fulfils conditions laid down in Article 15 of the Cosmetics Regulation and can therefore be used according to the restrictions.
Salicylic acid and its salts are currently listed in Annex V to Regulation 1223/2009 and are allowed for use in a concentration of up to 0.5 % (acid). Additionally, salicylic acid is also listed in Annex III and can be used for purposes other than preservative. In this case it can be used in rinse-off hair products in a concentration of up to 3% and in other products in up to 2 %. It is not allowed to be used in preparations for children under 3 years of age, except for shampoos.
Based on the SCCS scientific opinion on Salicylic acid, which was published on 21 December 2018, as well as classification of salicylic acid as eye irritant and as a CMR substance of category 2, the following amendments to current entries of ‘salicylic acid’ should be adopted:
- Salicylic acid and its salts are allowed for use as a preservative in a concentration up to 0.5 % (the currently allowed concentration), except for oral products, applications that may lead to exposure of end-user’s lungs by inhalation and products for children under 3 years of age.
- Salicylic acid is allowed for non-preservative use in:
- Rinse-off hair products in a concentration of up to 3 % (the currently allowed concentration)
- Other products, except for body lotion, eye shadow, mascara, eyeliner, lipstick and roll-on deodorant applications, in a concentration of up to 2 % (the currently allowed concentration)
- It is not allowed to be used in oral products, in applications that may lead to exposure of end-user’s lungs by inhalation and in products for children under 3 years of age
Substance Oxyquinoline has been classified as CMR substance of category 1B, while its sulphate form has not been classified as a CMR substance. Therefore, Oxyquinoline sulphate should be listed in Annex III and allowed for use in cosmetic products under the restrictions laid down in Annex III.
Additional 19 CMR substances or groups of CMR substances have been added to Annex II. One of these substances, disodium octaborate anhydrous will be added to the group of substances, which are already listed in Annex II.
The Commission Regulation was published in the Official Journal of the European Union, on 28 November 2019 and has entered into force twenty days later.
The full text of the regulation update can be seen here: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2019.307.01.0015.01.ENG&toc=OJ:L:2019:307:TOC