SCCS opinion on Salicylic Acid

The SCCS issued a preliminary opinion on Salicylic Acid with the CAS number “69-72-7” on December 15, 2022. The deadline for comments is February 17, 2023.

Salicylic acid (CAS No. 69-72-7, EC No. 200-712-3) with the chemical name ‘benzoic acid, 2-hydroxy’ is used in cosmetic products with reported functions as a denaturant, hair and skin conditioning agent, exfoliant/keratolytic, anti-sebum agent, anti-dandruff/anti-seborrheic agent and a product preservative.

Conclude:

1) In light of the data provided and taking under consideration the concerns related to the 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 cosmetics for purposes other than inhibiting the development of micro-organisms at a concentration up to:

(i) 3.0% for cosmetic rinse-off hair products,

(ii) 2.0% for other products except for 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 the 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 the 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.

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