Safety and efficacy of a feed additive consisting of Lacticaseibacillus casei IDAC 210415‐01, Limosilactobacillus fermentum IDAC 210415‐02, Levilactobacillus brevis IDAC 051120‐02 and Enterococcus faecium IDAC 181218‐03 (K‐9 Heritage Probiotic Blend®) for dogs (CanBiocin Inc.)
Meta data
Legal notice: Relevant information or parts of this scientific output have been blackened in accordance with the confidentiality requests formulated by the applicant pending a decision thereon by EFSA. The full output has been shared with the European Commission, EU Member States (if applicable) and the applicant. The blackening may be subject to review once the decision on the confidentiality requests is adopted by EFSA and in case it rejects some of the confidentiality requests.
Abstract
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of K‐9 Heritage Probiotic Blend® when used as a zootechnical additive (functional group: gut flora stabilisers) for dogs. The product under assessment is based on viable cells of Lacticaseibacillus casei IDAC 210415‐01, Limosilactobacillus fermentum IDAC 210415‐02, Levilactobacillus brevis IDAC 051120‐02 and Enterococcus faecium IDAC 181218‐03. The FEEDAP Panel was not in the position to conclude on the identification of the strains and, therefore, the safety of the product cannot be based on the presumption of safety of the active agents. The Panel notes that the use of E. faecium IDAC 181218‐03 represents a safety concern because it harbours an acquired antimicrobial resistance gene. Moreover, the hazard related to the presence of additional antimicrobial resistance genes in the active agents cannot be excluded. No tolerance trials on the target animals have been provided. Therefore, the Panel is not in the position to conclude on the safety of the additive for dogs. Regarding the user safety, the Panel cannot conclude on the irritant potential of the additive for skin or eyes due to the absence of data. Given the proteinaceous nature of the active agents, the additive should be considered a respiratory sensitiser. No conclusions could be drawn on its potential to be a skin sensitiser. The use of K‐9 Heritage Probiotic Blend® in animal nutrition represents a safety concern for the environment due to the potential carryover of at least an antimicrobial resistance gene. The FEEDAP Panel is not in the position to conclude on the efficacy of K‐9 Heritage Probiotic Blend® for the target species.