Salicylic acid (CAS No. 69-72-7, EC No. 200-712-3)

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: E. Benfenati, N. Cabaton (Rapporteur), E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz
Contact: SANTE-SCCSec [dot] europa [dot] eu (SANTE-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1646/22
Adopted on: 6-7 June 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 salicylic acid (CAS 69-72-7) is safe when used as preservative at a concentration of 0.5 % in cosmetic products, considering its current restrictions in place. 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 (including mouth spray) that may lead to exposure of end-user’s lungs by inhalation.

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 is safe at a concentration:
- up to 3.0 % for the cosmetic rinse-off hair products,
- up to 2.0 % for other products, except body lotion, eye shadow, mascara, eyeliner, lipstick, non-spray deodorant, and
- up to 0.5% for body lotion, eye shadow, mascara, eyeliner, lipstick, oral products and non-spray deodorant.

This Opinion is not applicable to any sprayable product (including mouth spray) that may lead to exposure of end-user’s lungs by inhalation.

(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Salicylic acid in cosmetic products? 

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(3) Does the SCCS have any further scientific concerns with regard to the use of Salicylic acid in cosmetic products? 

In the absence of exposure data of Salicylic acid in cosmetic products for children, safety concerns have been noted for the younger age groups (between 3-10 years).

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.

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, final version of 6-7 June 2023, SCCS/1646/22.