The European Food Safety Authority (EFSA) says it is unable to draw a firm conclusion on the safety of ethoxyquin as a feed additive for any target animals, its safety for consumers or the environment.
After its assessment, EFSA explained that the reason for its decision is 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 used in animal feed for its antioxidant properties and to prevent spontaneous combustion of fish meal during transportation by sea.
Commenting on the announcement from EFSA, the European Union Association of Specialty Feed Ingredients and their Mixtures (FEFANA) said it understands the limitations in the risk assessment due to data gaps identified by the EFSA experts. However, in a statement, FEFANA stressed the important role that ethoxyquin plays in animal nutrition, saying it is a highly effective antioxidant used to preserve the nutritional value of key ingredients of animal diets. Furthermore, ethoxyquin prevents the production of oxidative reactive compounds in these ingredients and favors shelf life by slowing down the development of rancidity in fats. While natural antioxidants can help, “ethoxyquin is currently the most efficient antioxidant for this use,” according to FEFANA.
“In order to address the critical data gaps, ANTOXIAC has already been taking actions, and will continue carrying out the appropriate studies to generate the data necessary to assess the safety of the product under the defined conditions of use. New insights will then be shared with the authorities,” the statement continued. ANTOXIAC is the FEFANA Antioxidants Authorisation Consortium.
In a joint statement with FEFAC and the Federation of European Aquaculture Producers (FAEP), the Marine Ingredients Federation (IFFO) stated that the European Commission will discuss the EFSA Opinion at the next Standing Committee for Plants, Animals, Food and Feed (SCOPAFF) meeting to be held on December 17-18, and that a decision may be taken then with regard to a new regulation on ethoxyquin as a feed additive. Alternatively, the Commission could decide to wait for outstanding results and gaps that need to be filled depending on the time it would take to complete the necessary data before issuing a new regulation.
“We have reason to be concerned that the European Commission, under political pressure, might take the EFSA Opinion as providing sufficient grounds to withdraw the authorization for ethoxyquin on precautionary grounds,” said the statement. “IFFO is preparing an impact document detailing the effect a withdrawal of ethoxyquin would have on the fishmeal, feed and aquaculture industries that we will hope to present to the European Commission before their meeting on 17-18 December.”
Explaining its reservations, EFSA says ethoxyquin itself is considered non-genotoxic. However, it has found that one of the 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. Furthermore, even in the absence of the impurity, EFSA identified gaps in the data when assessing the exposure and the safety of ethoxyquin for animals, consumers and the environment.
The assessment by EFSA took place in the framework of the re-evaluation procedure in place for all feed additives which were authorized under the previous legislation.