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SCCS Issued Final Opinion on Salicylic Acid - Children Exposure

May 30, 2025
European Union
Cosmetic Ingredient
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On 2 May, 2025, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued final opinion (SCCS/1675/25) on Salicylic Acid (CAS No. 69-72-7). The preliminary opinion was issued on 13 January, 2025.

Final Opinion on Salicylic Acid

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:

i. 3.0 % for cosmetic rinse-off products

ii. 2.0 % for cosmetic leave-on products except body lotion and oral products, and

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

During public consultation the SCCS has received a proposal of the Applicant to keep rinse-off products at 0.5%, reduce Salicylic Acid in leave-on products to 0.15% and oral Care products to 0.1%. Applying these concentrations Salicylic Acid is safe for children 3-10 years old.

3. 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 is currently assessing the cumulative exposure to salicylates and the implications for risk assessment.

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

Regulatory Requirements Interpretation of Salicylic Acid

The Global Cosmetic Ingredient Regulatory Database-Global CosIng, an upgraded version of China CosIng independently developed by CIRS Group indicates that Salicylic Acid has been included in the following key lists globally.

7

In China, Salicylic Acid has been included in the Inventory of Existing Cosmetic Ingredients in China (IECIC) and List of ingredients restricted in cosmetic products as well as List of preservatives allowed in cosmetic products in the Safety and Technical Standards for Cosmetics. Detailed information on the scope of use, applicable restrictions, and maximum permitted concentrations etc. can be found in the figures below.

10

13

For more detailed information about Global CosIng or if you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Information

https://health.ec.europa.eu/latest-updates/sccs-final-opinion-salicylic-acid-childrens-exposure-2025-05-02_en

https://health.ec.europa.eu/document/download/fa18e8c3-9bf2-40b8-b198-a064f259b19b_en?filename=sccs_o_297.pdf

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