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In January 2025, EU Scientific Committee on Consumer Safety (SCCS) issued preliminary opinions on butylparaben (CAS No. 94-26-8), salicylic acid (CAS No. 69-72-7), and methyl salicylate (CAS No. 119-36-8), focusing on their use in cosmetics intended for children. Taking into account the comments received during the public consultation, SCCS released final opinions on these substances on May 2, 2025.1-3
Below are the key conclusions from the SCCS's final opinions on the three substances, with revisions from the preliminary assessment highlighted in red.
Opinion on Butylparaben
Butylparaben is currently regulated as a preservative under Regulation (EC) No 1223/2009 (the Cosmetics Regulation), with a concentration limit of 0.14% (as acid) when used alone, or for the sum of its combined use with propylparaben and its salts. Following concerns about its safety in cosmetics for children, SCCS issued this opinion and concluded as follows:
For children aged 0.5-10 years, the use of butylparaben as a preservative at a maximum concentration of 0.14% (as acid) is:
Not safe in all assessed product categories when used in combination;
Safe in individual dermal or oral product category (excluding body lotion), provided it is used exclusively within the respective category.
To ensure safety across all considered children's age groups, SCCS recommends reducing the maximum concentration of butylparaben in certain product categories. Specifically, it is deemed safe to maintain a concentration of 0.14% (as acid) in rinse-off products, while reducing it to 0.002% (as acid) in leave-on products and 0.092% (as acid) in oral care products, whether used individually or in combination.
It is important to note that this opinion does not apply to sprayable products, including mouth sprays, which have the potential to cause lung exposure via inhalation.
Opinion on Salicylic Acid
At present, salicylic acid is listed in both the restricted ingredients list and permitted preservatives list of the Cosmetics Regulation, subject to specific maximum concentrations and use conditions. In an earlier opinion addressing its endocrine potential, SCCS highlighted the lack of exposure data for children aged 3-10 years, raising concerns about the safety of this age group. In response, the industry submitted additional data in November 2023, based on which SCCS reassessed the safety of salicylic acid and issued conclusions on its use in cosmetic products for children aged 3–10 years, as summarized 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 No. 2"; c. It is shown in the provided information that salicylic acid is an eye irritant with the potential to cause damage to the eye. Notes: These conclusions do not apply to sprayable products, including mouth sprays, that may cause lung exposure through inhalation. |
2 | Functions other than preservative | Rinse-off hair products (shampoo and conditioner) | 3% | 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% | |||
Body lotion | 0.5% |
In addition to the conclusions above, SCCS noted that lowering the concentration of salicylic acid would ensure its safe use in dermal products and toothpaste for children aged 3–10 years. To be specific, SCCS deems salicylic acid safe at concentrations of 0.5% in rinse-off products, 0.15% in leave-on products, and 0.1% in oral care products. As the Cosmetics Regulation bans its use in products for children under 3 years old, this group is excluded from the opinion. Besides, the conclusions pertain solely to salicylic acid as a cosmetic ingredient, and do not apply to other salicylates or salicylic acid salts.
Opinion on Methyl Salicylate
Under the current regulation, methyl salicylate is regulated as a restricted cosmetic ingredient in the EU, with specific concentration limits for various product types and age groups. In September 2023, SCCS released opinion SCCS/1654/23, setting safe-use concentrations for methyl salicylate in cosmetics for children aged 0.5–3 and 3–6 years. However, during its assessment of hexyl salicylate (addendum to SCCS/1658/23), SCCS observed a higher ingestion of toothpaste by children under 3 than previously accounted for in the methyl salicylate evaluation. This raised concerns over the conclusions in SCCS/1654/23, prompting a re-assessment of methyl salicylate by SCCS, and the issuance of this new opinion.
Based on SCCS/1658/23 and aggregate exposure data, SCCS updates its conclusions in SCCS/1654/23, reducing the safe-use concentration of methyl salicylate in toothpaste for children aged 0–3 years to 0.4%. It also reconfirms the substance's safety at a maximum concentration of 0.02% in other products.
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