SCCS OPINION on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3) - SCCS/1646/22 - Preliminary Opinion
Résumé
SCCS OPINION on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3) - SCCS/1646/22 - Preliminary Opinion
U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von Goetz
The SCCS adopted this document by writen procedure on 14 Décember 2022 (91 Pages)
Mise en ligne 15 December 2022
https://health.ec.europa.eu/publications/salicylic-acid-cas-no-69-72-7-ec-no-200-712-3_en
https://health.ec.europa.eu/system/files/2022-12/sccs_o_268.pdf
Details
Publication date : 15 December 2022
Author : Scientific Committee on Consumer Safety (SCCS)
Description
SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, E. Panteri (Rapporteur), V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
SCCS external experts: N. Cabaton, A. Koutsodimou (Rapporteur), W. Uter, N. von Goetz
Contact:SANTE-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1646/22
Adopted on: 14 December 2022
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:
i. 3.0% for the cosmetic rinse-off hair products,
ii. 2.0% for other products except body lotion, eye shadow, mascara, eyeliner, lipstick, non-spray deodorant, and
iii. 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.
Keywords:
SCCS, scientific opinion, salicylic acid, Regulation 1223/2009, CAS No. 69-72-7, EC No. 200-712-3)
Opinion to be cited as:
SCCS (Scientific Committee on Consumer Safety), Opinion on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3), preliminary version of 14 December 2022, SCCS/1646/22.