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4-Methylbenzyliden camphor (4-MBC): Endocrine Disruptor

4-Methylbenzyliden camphor (4-MBC) is an active ingredient commonly found in chemical sunscreens. 4-MBC functions to protect the skin from UVB exposure in the 290 – 320 nm range. This ingredient went viral after a TikTok content creator (@DosenSkincare) uploaded content that mentioned several local sunscreen brands and invited his audience to consider using these brands.

Why is this happening? Is 4-MBC harmful? And how do we know the chemical content in sunscreen?

Local Sunscreen Contains 4-MBC

4-MBC has been approved as a UV filter in sunscreen products based on Cosmetic Regulation No. 1223/2009 (Annex VI, entry 18). Meanwhile, in Indonesia, this chemical is regulated through BPOM Regulation No. 17/2022 on the Amendment of Food and Drug Administration Number 23 of 2019 on Technical Requirements for Cosmetic Ingredients. According to the regulation, the permitted maximum level is 4%, the same as implemented by the European Union.

The safety of 4-MBC has been tested several times (in 1998, 2001, 2004, 2006, and 2008) by the Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers (SCCNFP) and the Scientific Committee on Consumer Products (SCCP). However, earlier in 2019, the European Commission published a list of 28 potential endocrine disrupting substances. 4-MBC falls into class A, which is considered a high priority.

Therefore, the Scientific Committee on Consumer Safety (SCCS) conducted a safety reassessment on 4-Methylbenzyliden camphor in light of the data provided. Through its report, the SCCS could not conclude on the safety of 4-MBC due to the lack of data to evaluate potential genotoxicity. However, claim that stated the compound may act as an endocrine disruptor and have effects on the thyroid system and estrogen, is valid.

The SCCS re-evaluation of 4-Methylbenzylidene camphor, established a higher exposure level than previously stated. That is, the results indicate that the use of 4- Methylbenzylidene camphor with a maximum concentration of 4% in cosmetic ingredients is not safe due to a decrease in the Margin of Safety (MoS). Therefore, the European Commission issued a notification banning the use of 4-Methylbenzyliden camphor as a UV filter on June 8, 2023 and began to be implemented in the 4th quarter of 2023 in Europe.

Following this notification, BPOM will conduct a reassessment regarding the safety of 4-Methylbenzylidene camphor. However, it will be done when the ban has been implemented in the European Union. Eventually, this issue will be brought to the ASEAN Cosmetic Committee and reviewed by the ASEAN Cosmetic Scientific Body.

How to identify 4-Methylbenzylidene Camphor in sunscreen?

Since the nature of active ingredients can pose a risk of skin allergies and birth defects, their types and levels are strictly regulated. Table 1 below shows the list of active ingredients in sunscreens permitted in the European Union, the United States, China, and Japan.

list zat UV filter sunscreen
Table 1. Active ingredients in sunscreens and their permitted concentrations in the US, Japan, China and Europe.

Based on the table above, the active ingredients allowed in each country vary. For example, 3-(4-methylbenzylidene) camphor is permitted in Europe and China, but banned in the US and Japan.
In addition, there are some compounds that are not listed in these regulations, such as phenyl salicylate, but are still added to some sunscreens and could potentially cause health problems.

Therefore, a method to detect active substances simultaneously is required. HPLC methods are widely proven to be reliable for this application.

Chromatograms sunscreen
Figure 1. Chromatograms of (a) blank, (b) sunscreen sample, and (c) the same sample added with standards.

Figure 1 shows the chromatogram graph of the sample and the same sample added standard. Four UV filter substances in the sunscreen were detected, 2-hydroxy-4-methoxybenzophenone (peak 4), avobenzone butylmethoxydibenzoylmethane (peak 8), 2-ethylhexyl salicylate (peak 10), and 3,3,5-trimethylcyclohexyl salicylate (peak 11), while the other seven compounds were absent. To assess the accuracy of the method, recoveries of sunscreen samples to which mixed standards were added were analyzed. Recoveries ranged from 77 to 116% for the eleven sunscreen ingredients, indicating that the method is suitable for the determination of sunscreen ingredients in sunscreen creams.

Analysis of sunscreen creams after extraction with methanol, the results are presented below.

The amount of UV filter substances detected in sunscreen cream samples.
Table 2: The amount of UV filter substances detected in sunscreen cream samples.

Read more about the 4-Methylbenzyliden camphor analysis method using HPLC, here.

If you have any questions about sunscreen cream analysis using HPLC, please contact our team at sales@wiralab.co.id 

 

Reference:

criticalcatalyst.com

SCCS Opinion on 4-Methylbenzylidene camphor

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