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Monday, May 16, 2022Regulation

4-Methylbenzylidene Camphor : the SCCS final Opinion

4-Methylbenzylidene camphor : Opinion finale 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 final Opinion on the UV-filter 4-Methylbenzylidene Camphor (4-MBC). It was adopted by written procedure on 29 April 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.
The Scientific Committee issued its preliminary Opinion on 22 December 2021.

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
4-Methylbenzylidene Camphor : the SCCS preliminary Opinion, CosmeticOBS, 3 January 2022

This Opinion has been subject to a commenting period of eight weeks after its initial publication (from 22 December 2021 to 28 February 2022). Comments received during this period were considered by the SCCS. For this Opinion, main changes of the content occurred in sections 3.1, 3.2.4, 3.3.6, 3.3.10 and in the respective discussion sections.
The conclusion remained unchanged.

Final Opinion

1. In light of …

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