Safety and efficacy of a feed additive consisting of copper chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.)

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of copper chelate of ethylenediamine (Copper-EDA-Cl) as a feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) identified several issues related to the data provided concerning the chemical characteristics of the additive and, based on the information provided from an in vitro dissociation study, considered it unlikely that the additive consists only of copper mono-chelate of EDA but of several coexisting (copper) species. Therefore, in the absence of adequate experimental data and owing to the uncertainties identified, the Panel cannot conclude on its identity and characterisation of the additive. The FEEDAP Panel concludes that the additive is safe for chickens for fattening and reared for laying/ breeding but cannot conclude on the safety for other animal species/categories. The FEEDAP Panel cannot conclude on the safety of the additive for the consumer or the environment. The FEEDAP Panel concludes that handling the additive poses a risk to users by inhalation. The additive should be considered as non-irritant for the skin but corrosive for the eyes and a skin sensitiser. The Panel notes the uncertainties on the genotoxicity potential of the additive that might have an impact on the conclusions on the safety for the user. The FEEDAP Panel concludes that the additive is efficacious in providing copper to meet the nutritional requirements of this trace element in all animal species.