Safety Assessment RP658 Reduction of the Risk of Milk Fever and Subclinical Hypocalcaemia in Dairy Cows

An application was submitted to the Food Standards Agency in March 2021 from Phibro Animal Health Corporation (“the applicant”) for the modification of entry number 60 of the PARNUT regulation 2020/3541 , ‘Reduction of the risk of milk fever and subclinical hypocalcaemia’, to include Dietary Cation-Anion Difference (DCAD) values below 0. To support the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in evaluating the dossier, the Animal Feed and Feed Additives Joint Expert Group (AFFAJEG) and the Advisory Committee on Animal Feedingstuffs (ACAF) were asked to review the information from the applicant. Two main literature studies were presented to support the safety and efficacy of the PARNUT. No significant negative effect was seen on the health of animals fed the lower DCAD diets for any of the three studies. A further 14 studies presented through a literature review showed evidence of efficacy of the PARNUT when used at the proposed modified conditions. The AFFAJEG concluded that a modification of the regulation to include DCAD levels between -200 and 100 mEq/kg dry matter would not pose any additional risks to the target species and would be expected to improve efficacy. The views of AFFAJEG and ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.