What’s new?

On January 10 2025, the SCCS published its preliminary opinion on the safety of children’s exposure to Butylparaben, that complements their previous opinion in 2023. Butylparaben is currently regulated as a preservative under Annex V to the European Cosmetics Regulation No. 1223/2009 in a concentration up to 0.14 % (as acid) when used on its own or for the sum of its combined use with propylparaben and its salts.

In light of the new information provided, the SCCS considered that the use of Butylparaben as preservative at a maximum concentration of 0.14 % (as acid) in all cosmetic products included in the assessment was not safe for children between 0.5-1 years, 1-3 years, 3-6 years and 6-10 years when used in combination.

The SCCS considered that Butylparaben was safe in single dermal and oral product categories, when used only in the respective product category, with the exception of body lotion.

For all the children’s age groups that were assessed, the SCCS concluded that Butylparaben should be safe if it does not exceed 0.028% (as acid) in the final product. This value could eventually be reviewed when a dermal absorption study and exposure studies specifically tailored to European Union children become available.

This opinion is not applicable to any sprayable product (including mouthspray) that may lead to exposure of end-user’s lungs by inhalation.

Additionally, the opinion did not address Butylparaben’s environmental impact.

What now?

The opinion is open for comments until March 10 2025.

References:

Opinion on Butylparaben (CAS No. 94-26-8, EC No. 202-318-7) – children exposure