EFSA: Further Study of 4,5-epoxydec-2(trans)-enal Required

The European Food Safety Administration's (EFSA) panel on food contact materials, enzymes, flavorings and processing aids has released data on additional studies of 4,5-epoxydec-2(trans)-enal from flavoring group evaluation 226. 

Based on the July 12 data, 4,5-epoxydec-2(trans)-enal did not induce gene mutations in bacterial cells but was positive in an in vitro micronucleus assay. Therefore, 4,5-epoxydec-2(trans)-enal is considered an in vitro genotoxic agent. 

The panel stated that negative results obtained in an in vivo micronucleus assay cannot overrule the positive results of the in vitro micronucleus assay with and without S9-mix due to the lack of cytotoxicity in the bone marrow. As a result, the panel is recommending an in vivo Comet assay in rodents in order to verify possible genotoxic effects at the first site of contact (such as stomach/duodenum cells).

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