Safety Assessment RP666 Protural

An application was submitted to the Food Standards Agency in March 2021 from Taminco Finland Oy (“the applicant”) for the renewal of authorisation and new use of an additive (sodium benzoate-ProturalTM), under the category of ‘zootechnical additives” and functional group “Other zootechnical (increase of performance/weight gain parameters)”. The additive is proposed to be used in piglets from weaning to 35 kg (renewal), as well as in other growing Suidae (new use), with a proposed level of inclusion in feed of 4 kg/ 1,000 kg or 0.4% of complete feedingstuffs with a moisture content of 12%. 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 dossier and the supplementary information from the applicant. Following clarification with the applicant, ACAF was able to conclude on a recommended dose of 4000 mg/kg of complete feed with a moisture content of 12%. The Committee had no other causes for concern in Section II of the application. The initial EFSA evaluation in 20112 confirmed that the additive is safe for the target species, consumers and the environment at the proposed conditions of use. The applicant conducted a literature review covering the period January 2000 to February 2020 and found no reported negative effects in this time. Regarding user/worker safety, the additive is considered as potentially harmful by inhalation and an eye irritant. The additive is not a skin irritant. Given that the efficacy data that were provided only assessed its efficacy in piglets, the ACAF could conclude on the efficacy of sodium benzoate in piglets (suckling), piglets (weaning) and piglets (suckling and weaned piglets). Members concluded that Protural™ at a proposed level of inclusion in feed of 4 kg/ 1,000 kg has the potential to improve performance in these groups of animals. Results can be extrapolated to other growing Suidae at the same developmental stage.The views of AFFAJEG and ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.