Ethoxyquin: EFSA safety assessment inconclusive

EFSA cannot conclude on the safety of ethoxyquin as a feed additive for any target animals, its safety for consumers or the environment, 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.
November 19, 2015

The European Food Safety Authority (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.

The EU Association of Specialty Feed Ingredients and their Mixtures (FEFANA), acknowledges the publication of the EFSA opinion and understands the limitations in the risk assessment due to data gaps identified by the EFSA experts. However, FEFANA stresses the important role that ethoxyquin plays in animal nutrition.

It is a highly effective antioxidant used to preserve the nutritional value of key ingredients of animal diets. Its use prevents the production of oxidative reactive compounds in these ingredients and favours shelf life.

During the storage of animal feed lipid oxidation occurs. This process results in food rancidity which results into change of taste, scent, and colour, as well as into decrease of shelf life of the feed. Antioxidants are used to limit lipid oxidation and generation of undesired substances (i.e. ketones and aldehydes) and as a consequence to preserve quality and nutritional value of the product.

Without antioxidants fats go rancid and foul the feed. Many natural antioxidants may be effective in preserving feed, but in many cases such protection is insufficient. Therefore, synthetic antioxidants must be applied. Ethoxyquin is currently the most efficient antioxidant for this use.

Hence, it can be used at lower concentration than other authorised antioxidants. For safety reasons the use of antioxidants is even compulsory (by law and insurances) during transportation of certain ingredients, such as fats, to prevent that their autoxidation creates heat.

FEFANA is now reaching out to stakeholders across the entire feed chain, as well as to authorities, to follow-up, collaborate, address all relevant issues and contribute to the most appropriate regulatory developments, thereby prioritizing the production of safe and nutritious feed in the EU.

The opinion is available here