Safety Assessment on the Safety and Efficacy of an Additive of Bifidobacterium ⁠longum CNCM I-5642 (PP102I) as a Feed Additive for Dogs (RP1111)

Abstract

An application was submitted to the Food Standards Agency in May 2021 from Nestle Enterprises S.A. (‘the applicant’) for the new of authorisation of an additive (PP102I) Bifidobacterium longum CNCM I-5642, under the category of ‘zootechnical additives’ and functional group ‘physiological condition stabilisers’. The additive is proposed to be used at a recommended dose of 1 x 109 CFU/dog daily. 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 characterised, and that it is stable for 8 months when stored at 4°C, and in premixtures for 48 weeks at 32°C at 70% humidity, and for 88 weeks at 23°C at 60% humidity. Homogeneity in feed was also demonstrated. As an organism suitable for the QPS approach to assessment, the additive can be considered safe for the consumer, the target animal, and the environment. The additive is not an irritant to the skin. The additive is an irritant to the eyes and should be considered a potential skin sensitiser and respiratory sensitiser. Bifidobacterium longum CNCM I-5642 is efficacious for dogs at the proposed dose of 1 x 109 CFU/dog daily. The views of ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.