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Monday, June 12, 2023Regulation

Methylparaben, Butylparaben : preliminary Opinions of the SCCS

Methylparaben, Butylparaben : Opinions préliminaires du CSSC

Following the mandate given by the European Commission to the SCCS in the context of the safety assessment of substances with potential endocrine disrupting properties, the Scientific Committee has just published its preliminary Opinions on two parabens, Methylparaben and Butylparaben. They were adopted during the plenary meeting of the SCCS on 6 and 7 June 2023 and are open for comments until 21 August 2023.

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Background on substances with endocrine disrupting properties

The European Commission committed to establishing a priority list of potential EDs not already covered by bans or restrictions in the Cosmetics Regulation for their subsequent safety assessment. A priority list of 28 potential EDs in cosmetics was established. The Commission carried out a public call for data for 14 substances (Group A) and a second call in 2021 for 10 substances (Group B) in preparation of the safety assessment of these substances.

Methylparaben

Background

Methylparaben (CAS No.99-76-3, EC No.202-785-7) is currently regulated as a preservative (Annex V, entry 12) in a concentration up to 0.4% (as acid) when used on its own or up to 0.8% for mixtures of esters (Annex V, entry 12, column g).
During the call for data, stakeholders submitted scientific evidence to demonstrate the safety of Methylparaben as a preservative in cosmetic products.

For an exhaustive background information, see the articles
Endocrine disruptors: 2nd call for data from the European Commission, CosmeticOBS, 22 February 2021
Methylparaben, Benzyl Salicylate, Salicylic Acid: requests for SCCS Opinions, CosmeticOBS, 14 February 2022

Opinion

1. In light of the data provided and taking under consideration the concerns related to …

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