Safety Assessment on the Safety and Efficacy of an Additive of Zinc Chloride Hydroxide Monohydrate (IntelliBond® Z) as a Feed Additive for All Animal Species (RP814)

An application was submitted to the Food Standards Agency in March 2021 from Trouw Nutrition GB (‘the applicant’) for the renewal and modification of authorisation of an additive (IntelliBond ® Z) containing zinc chloride hydroxide monohydrate, under the category of ‘nutritional additives’ and functional group ‘compounds of trace elements’. The additive is proposed to be used at a maximum inclusion rate of: • 200 mg/kg in dogs and cats • 180 mg/kg in salmonids and milk replacers for calves • 150 mg/kg in piglets, sows, rabbits and all fish species other than salmonids • 120 mg/kg in all other species and categories To support the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in evaluating the dossier, the Advisory Committee on Animal Feedingstuffs (ACAF) were asked to review the dossier and the supplementary information from the applicant. The FSA/FSS concluded, based on the ACAF’s advice, that the additive was correctly identified and characterised and that the changes made to the manufacturing process did not pose an unacceptable risk to safety. The additive is safe for consumers and the target animal species. The additive is not a skin irritant or dermal sensitiser and is unlikely to form harmful amounts of respirable dust. The additive should be considered a potential eye irritant. The additive poses an acceptable risk to the environment under the proposed conditions for terrestrial species and land-based aquaculture systems. The Committee were unable to conclude on the safety of the additive for marine sediment when used in sea cages. The ACAF 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 this renewal. The views of ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.