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Regulation (EU) 2024/996 of the European Commission, of 04/03/2024, amends Regulation (EC) No. 1223/2009 of the European Parliament and of the Council with regard to the use of 3-(4'-methylbenzylidene )-camphor (4-MBC, CAS# 36861-47-9/38102-62-4) as it has the potential for endocrine disruption in cosmetic products, and has effects on both the thyroid system and estrogen and it is not possible to determine a maximum concentration for safe use of the substance. As of 04/24/2024, the 4-MBC UVB filter leaves the list of filters permitted in Europe Annex VI/18 and enters the list of substances prohibited in cosmetic products in Europe Annex II/1730.
In light of the SCCS opinion, it can be concluded that there is a potential risk to human health arising from the use of 4-MBC as a UV filter in cosmetic products. The substance will not be allowed as a UV filter in cosmetic products. Furthermore, there is no scientific basis to support that the SCCS conclusions on the safety of 4-Methylbenzylidene Camphor would not apply when that substance is used in cosmetic products with the additional functions reported as a “UV absorbing” and “UV stabilizing” agent. light". To ensure that 4-MBC does not continue to be used in cosmetic products for purposes other than as a UV filter, which would also pose a potential risk to human health, as identified in the SCCS opinion, the UVB filter 4-MBC is prohibited for all uses in cosmetic products. Furthermore, there is a possibility that 4-Methylbenzylidene Camphor is genotoxic.
In particular with regards to the ban on 4-methylbenzylidene camphor, reformulating products containing this UV filter is technically difficult, given the dwindling range of UV filters available on the global market, and the need to measure effectiveness. of the SPF sun protection factor of reformulated products. Therefore, longer transition periods should be allowed for industry to ensure compliance of products containing 4-methylbenzylidene camphor.
This Regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union 04/04/2024.
ELI: http://data.europa.eu/eli/reg/2024/996/oj
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