SCCS publishes preliminary scientific opinion on the safety of butylparaben cosmetic products for children

On 10 January 2025, the EU Scientific Committee on Consumer Safety (SCCS) adopted its preliminary opinion on the safety of using butylparaben as a preservative in cosmetic products for children. The deadline for comments is 10 March 2025.

Background on butylparaben as a preservative

Butylparaben (CAS No 94-26-89), a preservative in cosmetic products, has been subject to several safety evaluations by the SCCS and its predecessor, the Scientific Committee on Consumer Products (SCCP). In 2023, the SCCS re-assessed the safety of butylparaben due to potential endocrine-disrupting effects. The Scientific Committee confirmed its safety at concentrations up to 0.14%. However, the experts noted that potential safety concerns could not be excluded due to the lack of exposure data specific to children. In March 2024, the Commission received additional information from industry to defend the use of butylparaben in children's cosmetic products.

SCCS Committee opinion

The SCCS reached the following conclusion after a human risk study:

• Safety Assessment for Children: The SCCS has determined that the use of butylparaben as a preservative in cosmetic products at a maximum concentration of 0.14% is not safe for children aged 0.5-1 years, 1-3 years, 3-6 years, and 6-10 years when used in combination. However, it is safe in single dermal and oral product categories when used only in the respective product category, except for body lotion.
• Recommended Concentration: The SCCS recommends limiting the concentration of butylparaben in final products to 0.028% for children. However, the need for a reduction could be reconsidered after a thorough dermal absorption study and better exposure studies specifically tailored to EU children.

• Environmental Safety: The opinion does not cover the environmental safety of butylparaben as environmental aspects are not covered by the SCCS mandates.