New evidence on ethoxyquin

EFSA’s Scientific Opinion 1 on Ethoxyquin as a Feed Additive was published in November 2015, when the European Food Safety Authority (EFSA) could not conclude on the safety of the feed additive for target animals, for the consumers and for the environment due to a lack of data.

Among the items discussed, the EFSA could not conclude whether ethoxyquin quinone imine (an ethoxyquin metabolite) would potentially pose a health risk to the consumer, as there was no confirmation on the absence of genotoxicity for this compound.

However in the meantime the applicant (ANTOXIAC) has carried out an in vivo Micronucleus test (Guidelines OECD 474 and EC B.12) with quinone imine (EQI) in bone marrow cells of mice, which now rules out any potential genotoxic risk of QI.

This in vivo study had been initiated months in advance of the publication of the EFSA Opinion, as a follow up to the in vitro test indicated in the EFSA Opinion (page 15). At the same time, due to the publication date of the Opinion and timing of the study, findings from this additional toxicological trial could not be evaluated by the Authority, and the relevant results obtained were not considered in the Opinion ultimately published.

Based on results from this research, it is determined that EQI is not clastogenic or aneugenic in the bone marrow micronucleus test in mice up to the maximum tolerated dose in accordance with current regulatory guidelines. The findings confirm that EQI is not a genotoxic compound, therefore addressing one of the key data gaps listed by EFSA in its Scientific Opinion. The EFSA Opinion had already determined that ethoxyquin itself is not genotoxic or carcinogenic.

The final report of this study has already been made available to the European Commission for distribution to EU Member States and evaluation by EFSA. This additional information will help closing an important data gap and provide additional elements for risk assessment with regard to ethoxyquin.

Regarding other elements of concern raised by EFSA, the applicant is executing a very detailed study plan (Roadmap) to address all identified data gaps and enable a thorough assessment according to EU requirements. In this respect the efforts of the applicant also include adjustments on the production process in order to supply the market with a new quality of ethoxyquin in the near future.

The applicant remains fully committed to a transparent assessment of the safety of their product within the regulatory framework established by the European Union.

1 doi:10.2903/j.efsa.2015.4272: http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/4272.pdf