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On January 13, 2025, EU Scientific Committee on Consumer Safety (SCCS) launched a public consultation on its opinion on butylparaben (CAS No. 94-26-8), which addresses concerns related to children exposure. Comments are accepted until March 10, 2025.1
Butylparaben is currently regulated as a preservative under Regulation (EC) No 1223/2009, 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. It has been subject to several safety evaluations by the Scientific Committee on Consumer Products (SCCP) and its successor, SCCS. In the most recent opinion from November 2023, SCCS confirmed its safety at concentrations of up to 0.14% (as acid), but noted the absence of data on children exposure, suggesting potential safety concerns. In response, the industry provided additional information in March 2024, supporting the use of butylparaben in cosmetics intended for children. Consequently, SCCS conducted a new safety assessment and issued this opinion.
Based on the latest assessment results, SCCS presents the following conclusions in the opinion:
For children aged 0.5-10 years, the use of butylparaben as a preservative at a maximum concentration of 0.14% (as acid) is:
i. Not safe in all assessed product categories when used in combination;
ii. Safe in individual dermal or oral product category (excluding body lotion), provided it is used exclusively within the respective category.
To ensure safety for all considered children's age groups, the maximum concentration of butylparaben in final products should not exceed 0.028% (as acid).
Notably, this opinion does not apply to sprayable products, including mouth sprays, that may cause lung exposure through inhalation.
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