The last SCCS assessment was performed in view of the classification of Salicylic acid as a CMR2 (Repr.2) substance under the CLP Regulation and in accordance with the provisions laid out in Article 15 of the Cosmetics Regulation.
It is currently regulated under Annex III (entry 98) and Annex V (entry 3), with specific maximum concentrations and conditions of use.
Following the mandate given by the European Commission to the SCCS in the context of the safety assessment of substances with potential endocrine disrupting properties, the Scientific Committee has just published its preliminary opinion on Salicylic Acid. It was adopted by written procedure on 14 December 2022 and is open for comments until 17 February 2023.
Conclusion of the opinion:
(1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Salicylic acid,
a) does the SCCS consider Salicylic acid safe when used as a preservative in cosmetic products up to a maximum concentration of 0.5%?
Based on the safety assessment carried out in consideration of all available information, including the potential endocrine effects, the SCCS is of the opinion that:
– the use of salicylic acid as a preservative up to a maximum concentration of 0.5% is safe in either oral or dermal products, but not safe in oral and dermal products together for adults, adolescents, and children (>3 years).
– the provided information shows that salicylic acid is an eye irritant with the potential to cause serious damage to the eye.
– this Opinion is not applicable to any sprayable product that may lead to exposure of end-user’s lungs by inhalation. Since the Cosmetic Regulation does not allow the use of salicylic acid in products for children under 3 years of age, this age category has not been considered in this Opinion.
b) does the SCCS consider Salicylic acid safe when used in cosmetic for purposes other than inhibiting the development of micro-organisms at a concentration up to:
- 3.0% for the cosmetic rinse-off hair products,
- 2.0% for other products except body lotion, eye shadow, mascara, eyeliner, lipstick, non-spray deodorant, and
- 0.5% for body lotion, eye shadow, mascara, eyeliner, lipstick, oral products and non-spray deodorant
The SCCS assessment has shown that:
– the use of salicylic acid as a restricted ingredient for purposes other than inhibiting the development of micro-organisms at the concentrations specified in Annex III/98 of the Cosmetic Regulation (EC) No. 1223/2009 is safe in either oral or dermal products, but not safe in oral and dermal products together for adults, adolescents and children (>3 years).
– this Opinion is not applicable to any sprayable product that may lead to exposure of end-user’s lungs by inhalation. Since the Cosmetic Regulation does not allow the use of salicylic acid in products for children under 3 years of age, this age category has not been considered in this Opinion.
(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Salicylic acid in cosmetic products?
For safe use of salicylic acid in cosmetic products, the Applicant may consider either reducing the maximum use levels of salicylic acid in one or more product categories, and/or excluding the use for one or more product categories.
(3) Does the SCCS have any further scientific concerns with regard to the use of Salicylic acid in cosmetic products?
The conclusions of this Opinion refer only to Salicylic Acid as a cosmetic ingredient and not to other salicylates or salicylic acid salts.
Source: https://health.ec.europa.eu/publications/salicylic-acid-cas-no-69-72-7-ec-no-200-712-3_en