Monday, January 3, 2022SCCS

4-Methylbenzylidene Camphor : the SCCS preliminary Opinion

4-Methylbenzylidene camphor : Opinion préliminaire 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 Opinion on 4-Methylbenzylidene Camphor (4-MBC). It was adopted by written procedure on 22 December 2021 and is open for comments until 28 February 2022.

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Background

In cosmetic products, the ingredient 4-MBC (CAS No.36861-47-9/38102-62-4, EC No.253-242-6/-) with the chemical name 3-(4’-methylbenzylidene)-camphor is currently regulated as a UV-filter in sunscreen products in a concentration up to 4% (Annex VI/18).
During the call for data, stakeholders submitted scientific evidence to demonstrate the safety of 4-MBC as a UV-filter in cosmetic products. The Commission requests the SCCS to carry out a safety assessment on 4-MBC in view of the information provided.

For an exhaustive background information, see the articles
Endocrine disruptors: 2nd call for data from the European Commission, CosmeticOBS, 22 February 2021
Endocrine disruptors: 5 new requests for SCCS Opinions, CosmeticOBS, 15 March 2021

Opinion

1. In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of 4-Methylbenzylidene camphor (4-MBC), does the SCCS consider 4-MBC safe when used as a UV-filter in cosmetic products up to a maximum concentration of 4%?

The SCCS cannot conclude on the safety of 4-MBC, because the information provided is insufficient to fully evaluate potential genotoxicity.
Moreover, there is sufficient evidence that 4-MBC may act as an endocrine disruptor and has effects on both the thyroid and estrogen systems. Effects …

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