An application was submitted to the Food Standards Agency in May 2023 to extend the scope of the conditions of use associated with an existing feedstuff for particular nutritional purposes (PARNUT). Intraruminal boluses can be used to provide a long-term supply of trace elements and vitamins to grazing animals, specifically ruminants with functional rumen. Under this use, they are classified as a PARNUT. Up to 20% inert, non-bioavailable iron can be added to the bolus as a means to increase density and ensure that the bolus is retained in the reticulum of the animal. The applicant proposed the inclusion of up to 75% inert, non-bioavailable copper in a bolus as an alternative to iron. 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 copper in a bolus ballast is inert and that leaching of copper into the rumen is highly unlikely. The copper in a bolus ballast is not bioavailable to the animal, therefore the risk of toxicity to target animals and consumers is low. The use of up to 75% inert copper as an alternative to up to 20% inert iron in a PARNUT bolus poses no additional risk to the target animals, consumers, users or the environment. The views of the ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.
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