SCCS Opinion on Salicylic Acid (CAS No. 69-72-7, EC No. 200-712-3) - Children’s exposure

SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
SCCS external experts: E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro , W. Uter, N. von Goetz (Rapporteur)
Contact: SANTE-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1675/25
Adopted on: 10 January 2025

Conclusion of the opinion:

(1) In light of the data provided, and taking under consideration the conclusions of the SCCS/1646/22 Opinion on children’s exposure, does the SCCS consider Salicylic Acid safe for children between 3-10 years of age: 

a) 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 not safe when used as preservative at a concentration of 0.5% in all cosmetic products listed under conclusion (b), considering its current restrictions in place. With the exception of body lotion, it is safe in single dermal and oral product categories, when used only in the respective product category.
• this Opinion is not applicable to any sprayable product (including mouth spray) that may lead to exposure of end-user’s lungs by inhalation.
• The provided information shows that Salicylic Acid is an eye irritant with the potential to cause serious damage to the eye.

b) when used for purposes other than inhibiting the development of micro-organisms at a concentration up to:

• 3.0 % for cosmetic rinse-off products
• 2.0 % for cosmetic leave-on products except body lotion and oral products, and
• 0.5 % for body lotion and oral products

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 not safe at the following concentrations when aggregate exposure is considered:

- up to 3.0% for the cosmetic rinse-off hair products used by children (shampoo, conditioner),

- up to 2.0% for selected other dermally applied products used by children (face moisturizer, hand cream, liquid soap, shower gel), and

- up to 0.5% for body lotion.

With the exception of body lotion, it is safe in single dermal and oral product categories, when used only in the respective product category.

(2) Alternatively, what is according to the SCCS the maximum concentration of Salicylic Acid that is considered safe for children 3-10 years of age?

Reducing the concentration, for example to 0.1% in dermal products, would make the use safe for dermal products and toothpaste.

(3) Does the SCCS have any further scientific concerns with regard to the use of Salicylic Acid in cosmetic products and children’s exposure?

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.

The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Salicylic Acid for the environment.

Keywords:

SCCS, scientific opinion, salicylic acid, children exposure, 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)- children exposure, preliminary version of 10 January 2025, SCCS/1675/25.