As part of its assessment of the safety of substances that may have endocrine disrupting properties, the SCCS published its Final Opinions on Butylparaben (in October 2023) and Salicylic Acid (in June 2023), each time expressing reservations about the use in children’s products. As the industry has provided data to defend this use, the Scientific Committee reconsidered the issue, and has just published its preliminary Opinions.
Butylparaben
Background
The ingredient Butylparaben (CAS No.94-26-8, EC No.202-318-7) is currently regulated as a preservative (Annex V, entry 12a) in a concentration up to 0.14 % (as acid) when used on its own or for the sum of its combined use with propyl paraben and its salts (Annex V, entry 12a, column g).
In the SCCS/1651/23 Opinion, the scientific committee confirmed the safety of Butylparaben as a preservative in cosmetic products at concentrations of up to 0.14% (expressed as acid). Nevertheless, the experts noted that “In the absence of exposure data specific for children to Butylparaben in cosmetic products, potential safety concerns cannot be excluded.”
In March 2024, the Commission services received additional information from industry to defend the use of Butylparaben in cosmetic products used in children (covering infants - 6-12 months, toddlers - 1-3 years and children - 3-10 years).
For an exhaustive background information, see the articles
• Endocrine disruptors: 2nd call for data from the European Commission, CosmeticOBS, 22 February 2021
• Butylparaben, Benzyl Salicylate: final Opinions of the SCCS, CosmeticOBS, 13 November 2023
• Children’s exposure to Butylparaben and Salicylic Acid: requests for Opinions to the SCCS, CosmeticOBS, 8 April 2024
Opinion …
