SCCS OPINION on 4-Methylbenzylidene camphor (4-MBC) - SCCS/1640/21 - Preliminary version

International audience4-Methylbenzylidene camphor (4-MBC)SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam (Rapporteur), E. Gaffet, C.L. Galli, B. Granum, E. Panteri (Rapporteur), V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzContact: SANTE-C2-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1640/21Adopted on: 22 December 2021Conclusion of the opinion:(1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of 4-Methylbenzylidene camphor (4-MBC), does the SCCS consider 4-MBC safe when used as a UV-filter in cosmetic products up to a maximum concentration of 4%?The SCCS cannot conclude on the safety of 4-MBC, because the information provided is insufficient to fully evaluate potential genotoxicity.Moreover, there is sufficient evidence that 4-MBC may act as an endocrine disruptor and has effects on both the thyroid and estrogen systems. Effects on the thyroid and estrogen systems occur at oral exposure levels of 50 and 100 mg/kg bw/day or higher, respectively. Effects on the androgen system are not so evident, as only in vitro evidence is available.Even if the genotoxic potential was excluded, the current re-evaluation of 4-MBC established a higher exposure level than in the previous Opinion. This would result in a lower MoS value, indicating that the use of 4-MBC at the maximum concentration of 4% in cosmetic ingredients would not be safe.(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of 4-MBC as a UV-filter in cosmetic products?It is not possible to derive a maximum concentration for safe use of 4-MBC, because a genotoxicity potential cannot be excluded.(3) Does the SCCS have any further scientific concerns with regard to the use of 4-MBC in cosmetic products?The SCCS mandate does not address environmental aspects. Therefore, this assessment did not cover the safety of 4-MBC for the environment.Keywords:SCCS, revision, scientific opinion, 4-Methylbenzylidene camphor (4-MBC), CAS No 36861-47-9/38102-62-4, EC No 253-242-6, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), scientific opinion on 4-Methylbenzylidene camphor (4-MBC), preliminary version of 22 December SCCS/1640/21