Safety Assessment on the Safety and Efficacy of an Additive of Dicopper Chloride Trihydroxide (IntelliBond® C) as a Feed Additive for Use in All Animal Species (RP812)

An application was submitted to the Foods Standard Agency in March 2021 from Trouw Nutrition GB (‘the Applicant’) for the renewal and modification of an additive (IntelliBond ® C) containing dicopper chloride trihydroxide, under the category of ‘nutritional additives’ and functional group ‘compounds of trace elements’. The additive is proposed to be used in all animal species. The Advisory Committee on Animal Feedings (ACAF) was asked to review the dossier and the supplementary information submitted by the Applicant, and to advise the Food Standards Agency and Food Standards Scotland (FSA/FSS) in evaluating the dossier. The FSA/FSS concluded, based on the ACAF’s evidence, that the additive was fully identified and characterised, and no further concerns were raised for this section of the dossier. The use of the additive at recommended levels of incorporation into feed can continue to be considered safe for the target species and the consumer. Regarding user safety, the additive was determined to be non-corrosive and is not a skin sensitiser, however, is a skin irritant and should be regarded as a potential eye irritant. Following a request for a Phase I environmental risk assessment, the ACAF concluded that the additive poses an acceptable risk to the environment when used at the proposed levels for terrestrial species and land-based aquaculture systems. However, the safety of the additive for marine sediment when used in sea cages could not be concluded upon. It was concluded that the proposed minor modifications to the specifications and other provisions would not affect efficacy and therefore efficacy could be extrapolated from the original authorisation to the modified authorisation. The views of ACAF have been taken into account in this safety assessment which represents the opinion of the FSA/FSS.