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Study Design

Type
Review
Population
dogs
Methods
EFSA scientific opinion on the safety and efficacy of FlorEquilibre® Chien when used as a zootechnical additive (functional group: gut flora stabilisers)
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of FlorEquilibre® Chien when used as a zootechnical additive (functional group: gut flora stabilisers) for dogs. The product under assessment is based on viable cells of Lactobacillus acidophilus CNCM I-3231, Ligilactobacillus salivarius CNCM I-3233, Lactiplantibacillus plantarum CNCM I-3232, Lacticaseibacillus rhamnosus CNCM I-4427 and Bifidobacterium animalis subsp. lactis CNCM I-3993. L. acidophilus CNCM I-3231, L. salivarius CNCM I-3233, L. plantarum CNCM I-3232 and L. rhamnosus CNCM I-4427 are considered by EFSA to be suitable for the qualified presumption of safety approach. The identity of these strains was established, and no acquired antimicrobial resistance genes were detected. Therefore, the FEEDAP Panel concluded that the use of these four strains is presumed safe for the target species and the environment. However, the Panel notes that the use of B. animalis subsp. lactis CNCM I-3993 represents a safety concern for the target species, the users and the environment because the strain harbours an acquired antimicrobial resistance gene. The Panel concluded that the additive is eye irritant, and a skin and respiratory sensitiser. Exposure via any route is considered a risk. Based on the data provided, the Panel is not in the position to conclude on the efficacy of the additive for dogs.

Research Insights

SupplementDoseHealth OutcomeEffect TypeEffect SizeSource
Bifidobacterium plantarumNo Conclusive EfficacyNeutral
Small
View source

Based on the data provided, the Panel is not in the position to conclude on the efficacy of the additive for dogs.

Bifidobacterium plantarumSafety Concern in Target SpeciesHarmful
Moderate
View source

the Panel notes that the use of B. animalis subsp. lactis CNCM I-3993 represents a safety concern for the target species, the users and the environment because the strain harbours an acquired antimicrobial resistance gene.

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