The multi-brand sunscreen "4-methylbenzylidene camphor" is banned in the European Union.
On 3 April 2024, the Official Journal of the European Union published the latest amendments to the EU Cosmetics Regulation (EC) 1223/2009, which covers the management of the prohibition and restriction of a number of popular ingredients. Among them, the latest European Commission regulation (EU) 2024/996 changes the sunscreen of 4-methylbenzyl subunit camphor (4-MBC) from "restricted" to "banned".
Popular sunscreens are banned for reasons that may interfere with endocrine and affect the thyroid and estrogen systems
4-Methylbenzyl subunit camphor (4-MBC), an organic camphor derivative, is a chemical sunscreen that mainly absorbs ultraviolet rays. Camphor derivatives are absorbers with high stability to ultraviolet rays, and are widely used in sunscreen cosmetics, among which 4-methylbenzyl camphor is the most widely used.
Prior to this regulatory amendment, it was one of the UV filters approved by the European Union, with a maximum allowable concentration of 4%. In June 2023, the European Union issued a notice to revise the list of prohibited substances for cosmetics (Appendix II), including the proposed ban on 4-methylbenzylidene camphor (4-MBC), and the deadline for comments on the revision of the standard is August 7, 2023. It has taken about 10 months since the announcement was issued on June 8, 2023.
In fact, over the past two decades, the EU has conducted several security assessments of the 4-MBC. In 2008, the SCCP (predecessor of SCCS) considered the maximum safe concentration of 4-MBC to be 4%, but this assessment concluded that it did not include cosmetics that came into contact by inhalation (via aerosols, sprays, etc.) or oral mucosa (through lip care products).
In 2022, SCCS noted in its draft evaluation opinion SCCS/1640/21 that after a re-evaluation of the safety of 4-MBC, SCCS found that its exposure was higher than the previous assessment level, which means that it is no longer safe to use 4-MBC at a maximum concentration of 4% in cosmetic ingredients. However, due to the insufficient information provided to fully assess its potential genotoxicity, SCCS is unable to draw conclusions about the safety of 4-MBC.
According to the revised notification, there is ample evidence that 4-MBC may act as an endocrine disruptor with effects on both the thyroid and estrogen systems, and SCCS is unable to determine the maximum safe dosage of 4-MBC. Based on the opinion of the SCCS, it can be concluded that the use of 4-MBC as a UV filter in cosmetics is a potential risk to human health.
For these reasons, the European Commission concluded that 4-methylbenzylidene camphor should no longer be allowed to be used as a sunscreen in cosmetics. To ensure that 4-methylbenzylidene camphor does not pose a potential risk to human health, the substance should be banned for all uses in cosmetics.
The amendments to the EU cosmetics regulation will come into force on April 23, 2024. From 1 May 2025, products containing this substance may not be placed on the EU market. From 1 May 2026, cosmetics containing the substance may not be sold on the EU market.
Well-known sunscreens such as SkinPro, Osman, and Pechoin contain 4-MBC in their formulations
At present, 4-methylbenzyl subunit camphor belongs to the permitted sunscreen for cosmetics in mainland China, with a maximum limit of 4%.
According to consumer reports, there are many sunscreen products on sale in China that contain such ingredients, and many of them are familiar to consumers. Including SkinBaby, Osman, Pechoin, Key Secret, Tijiating, HFP, Kangaroo Bibi, Yilian, etc.
Among them, Meifubao, Osman, Pechoin, HFP, Kangaroo Bibi, and Yilian are domestic brands.
The secret of the key, Ti Jia Ting is a foreign imported product.
At present, countries around the world are continuously monitoring the safety risks of ingredients in cosmetics, especially in the sunscreen category. As research into sunscreens continues, changes in human activity and the environment can lead to changes in exposure, which means that the "safe concentration" in the standard is not set in stone.
Previously, there were many controversies about the safety risks of sunscreens such as benzophenone-3 and octocrylene, and the main reason was also endocrine disruption. In order to protect the health of consumers, the European Union has also lowered the maximum concentration of the above-mentioned sunscreens several times, and most sunscreen products on the market have gradually reduced the use of these sunscreens.
Professor Li Huiliang, director of the Professional Committee of the China Cosmetics Research Center, told consumer reports that orylclin will decompose benzophenone over time, which has a certain risk to human health, so there is a certain controversy about octocrylene in sunscreen cosmetics. He proposed that in order to ensure human health and care for the environment, we should try to use less or no such sunscreens.
With the introduction of EU policies, including the US FDA and Thailand, a ban on sunscreens such as 4-methylbenzylidene camphor has been issued in the early years, although 4-methylbenzylidene camphor is currently allowed to be used in sunscreen products in China, the specification and standard of this sunscreen may change in the future.
In the area of cosmetics standard management, Peng Guanjie, a senior cosmetics formulator, told consumer reports, "Sunscreen products are products that are strictly regulated in every country. There are not many varieties of sunscreen raw materials that can be used at present, and the special certificate declaration cycle of sunscreen products is very long, and the cost is also very high, and it takes a certain period to renew. ”
In mainland China, the safety supervision of finished cosmetics and raw materials is very strict. The latest revision of the Catalogue of Prohibited Raw Materials for Cosmetics includes 1,284 prohibited ingredients, and 109 prohibited substances are included in the Catalogue of Prohibited Plant (Animal Raw Materials) for Cosmetics, with a total of 1,393 items. Since the release of the relevant standards and specifications for cosmetics in mainland China, due to the continuous production of new raw materials and the continuous research and monitoring of raw material safety, the revision and supplementation of the standards have been in progress.