Assessment on the Safety and Efficacy of a Feed Additive Consisting of <i>Saccharomyces cerevisiae</i> CNCM I-1079 for Dogs and All Other Canidae (Lallemand Animal Nutrition UK Ltd.) (RP2105)

An application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in July 2023 from Lallemand Animal Nutrition UK Ltd. (“the applicant”) for the authorisation of an additive consisting of Saccharomyces cerevisiae CNCM I-1079 under the category ‘zootechnical additives’, functional group ‘gut flora stabilisers’, for a new use in dogs and other Canidae. In 2024, the European Food Safety Authority (EFSA) published a scientific opinion on the safety and efficacy of a feed additive consisting of Saccharomyces cerevisiae CNCM I-1079 for dogs and all other Canidae. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the active agent is suitable for the EFSA Qualified Presumption of Safety (QPS) approach and is safe for the target species, consumers and the environment. The non-coated form of the additive is not a skin or eye irritant, but no conclusion could be drawn on the eye irritation potential of the coated form. Both forms are presumed skin and respiratory sensitisers. The FEEDAP Panel were unable to conclude on efficacy in dogs and other Canidae. In 2025, following EFSA’s assessment, the applicant provided the FSA with additional information on efficacy in dogs. The FSA asked the Advisory Committee on Animal Feedingstuffs (ACAF) for advice on the efficacy data provided. The ACAF advised that S. cerevisiae CNCM I-1079 has the potential to be efficacious in gestating and lactating bitches and their puppies at the proposed dose of 1 x 10 9 CFU/kg feed. This conclusion can be extrapolated to all dogs and all other Canidae under the proposed conditions of use. The FSA/FSS have reviewed the applicant’s authorisation application, supporting documentation, ACAF’s assessment on efficacy, and other regulator’s risk assessments, most notably the EFSA risk assessment opinion, and considers that sufficient evidence has been demonstrated to conclude without the need for further questions or risk assessment.