Ethoxyquin: EFSA safety assessment inconclusive

The European Food Safety Authority (EFSA) cannot conclude on the safety of ethoxyquin as a feed additive for any target animals, its safety for consumers or the environment. This is due to an overall lack of data to assess the safety of the substance, including its metabolites, and the presence of an impurity (p-phenetidine) which is a possible mutagen. EFSA was asked to re-assess the safety of the feed additive ethoxyquin for target animals, consumers, users and the environment under EC Regulation 1831/2003. The substance is currently used in animal feed for its antioxidant properties. Ethoxyquin is also used to prevent spontaneous combustion of fish meal during transportation by sea. The substance ethoxyquin itself is considered non-genotoxic. EFSA, however, found that one of its metabolites, ethoxyquin quinone imine, could be genotoxic – i.e. it may damage DNA – indicating a potential safety concern. As a result of the manufacturing process, an impurity remains in this feed additive, p-phenetidine, which is a possible mutagen. Mutagens are substances causing mutations in the genetic material of both animals and humans. In addition to these findings and even in the absence of the impurity p-phenetidine, EFSA identified considerable data gaps when assessing the exposure and the safety of ethoxyquin for animals, consumers and the environment. The assessment took place in the framework of the re-evaluation procedure in place for all feed additives which were authorised under the previous legislation. A copy of the scientific opinion is available at: Scientific opinion: Safety and efficacy of ethoxyquin (6-ethoxy-1,2-dihydro-2,2,4-trimethylquinoline) for all animal species.

EFSA, 18 November 2015 ; ;