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UK SAG-GS Issued Opinion on 4-MBC as a UV Filter in Cosmetic Product

Jun 04, 2025
United Kingdom
Cosmetic Ingredient
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On May, 2025, Scientific Advisory Group of Chemical Safety of Non-food and Non-medicinal Consumer Products (SAG-GS) issued opinion on 4-Methylbenzylidene Camphor (4-MBC) as a UV Filter in Cosmetic Product.

SAG-GS concludes the following:

Members did not have access to the full industry data package for 4-MBC even though this had been requested by the OPSS. In the absence of data from industry and an incomplete data package it was necessary to draw conclusions from the published opinions from other authoritative bodies such as the SCCS. Members noted that the SCCS was unable to derive a safe level for 4-MBC in cosmetics.

The Members agreed that 4-MBC exhibits endocrine disrupting properties in in vivo studies. The Members noted concerns with regard to the safety of 4-MBC including the lack of a robust genotoxicity and reproductive/developmental toxicity package and concerns with regard to endocrine disruption properties. The Members were not able to derive a safe level for use of 4-MBC in cosmetics.

Given the limited data package available for review, and potential concerns for genotoxicity and endocrine disruption, the SAG-CS could not conclude that 4-MBC is safe for use in sunscreen products and other cosmetic products.

Regulatory Requirements Interpretation of 4-MBC

The Global Cosmetic Ingredient Regulatory Database-Global CosIng, an upgraded version of China CosIng independently developed by CIRS Group indicates that 4-Methylbenzylidene Camphor (CAS No. 38102-62-4/36861-47-9) has been included in the following key lists globally.

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In China, 4-MBC has been included in the Inventory of Existing Cosmetic Ingredients in China (IECIC) and List of ingredients restricted in cosmetic products as well as List of UV filters allowed in cosmetic products in the Safety and Technical Standards for Cosmetics. The maximum concentration in ready for use preparation is 4%.

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Furthermore, in UK, 4-MBC has been included on the list of substances permitted for use up to a concentration of 4% as a UV filter within Annex VI (Entry 18) of the Cosmetic Products Regulation UK No 1223/2009 (as amended).

About CIRS

The CIRS cosmetic team is dedicated to ensuring that cosmetic products meet stringent global regulatory standards. It can provide one-stop services covering the whole life-cycle of a personal care product, which includes cosmetic ingredient development, physical/chemical tests, toxicological tests (in vivo & in vitro), efficacy studies (in vivo & in vitro), ingredient registration, and product registration.

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If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Information

https://www.gov.uk/government/groups/scientific-advisory-group-on-chemical-safety-in-consumer-products

https://assets.publishing.service.gov.uk/media/682ddebab33f68eaba95390b/sag-cs-opinion-18-4-mbc-as-a-uv-filter-in-cosmetic-products.pdf 

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