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On January 13, 2025, EU Scientific Committee on Consumer Safety (SCCS) published a new opinion on salicylic acid (CAS No. 69-72-7), with a specific focus on its exposure risks on children. The opinion is open for public comments until March 10, 2025.1
Context of the Latest Safety Assessment
Salicylic acid is commonly used in cosmetics, serving functions such as a denaturant, anti-dandruff agent, preservative, exfoliant, and skin conditioning agent. Currently, it is listed in both the restricted ingredients list and permitted preservatives list of Regulation (EC) No 1223/2009 (the Cosmetics Regulation), with specific maximum concentrations and use conditions.
To ensure its safe use in cosmetics, salicylic acid has previously been subject to safety evaluations concerning its non-preservative uses, reproductive toxicity, and potential endocrine effects. In the opinion addressing its endocrine potential, SCCS confirmed the existing maximum concentration limits for salicylic acid in the relevant product types. However, SCCS noted a lack of exposure data for children aged 3-10 years, raising concerns regarding the safety of this age group.
Following this note, in November 2023, the industry submitted additional information to the European Commission to defend the use of salicylic acid in cosmetics for children aged 3-10 years. Therefore, the Commission has tasked SCCS with assessing the safety of salicylic acid in light of the newly provided information.
Key Conclusions from the Assessment
Based on the safety assessment conducted with all available information, SCCS draws conclusions regarding the safety of salicylic acid in cosmetics for children aged 3-10 years, as detailed in the table below:
Conclusion No. | Function of Salicylic Acid | Product Type | Maximum Concentration | Conclusion Details |
1 | Preservative | / | 0.5% | a. It is not safe to use salicylic acid under this condition in any of the products listed under the "Product Type" column in "Conclusion 2";
|
2 | Functions other than preservative | Rinse-off hair products (shampoo and conditioner) | 3.0% | 1. It is not safe to use salicylic acid under these conditions; |
Selected dermally applied products (face moisturizer, hand cream, liquid soap, and shower gel) | 2.0% | |||
Body lotion | 0.5% |
In addition to the conclusions above, SCCS highlighted that reducing the concentration, for example to 0.1% in dermal products, would render salicylic acid safe for use in dermal products and toothpaste. As the Cosmetics Regulation bans its use in products for children under 3 years old, this group is excluded from the opinion. Additionally, the conclusions pertain solely to salicylic acid as a cosmetic ingredient, and do not apply to other salicylates or salicylic acid salts.
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