Assessment of the efficacy of a feed additive consisting of Bifidobacterium longum CNCM I‐5642 (PP102I) for dogs (Nestlé Enterprises S.A.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of <i>Bifidobacterium longum</i> CNCM I-5642 (PP102I) as a zootechnical feed additive (functional group: physiological condition stabiliser) for dogs. In a previous opinion, the FEEDAP Panel concluded that PP102I was safe for dogs and the environment. Regarding the safety for the users, the Panel concluded that the additive should be considered a skin and respiratory sensitiser. Due to the lack of data, no conclusions could be drawn on the potential for skin/eye irritancy of the additive. Due to the lack of sufficient data, the Panel could not conclude on the efficacy of the additive for dogs at the proposed conditions of use. The applicant submitted in vitro eye and skin irritation tests and one efficacy trial in dogs to address the inconclusive aspects of the previous assessment. Based on the data provided, the Panel considers that the additive is irritant to the eyes but not to the skin. The additive has the potential to be efficacious when included in feed for dogs at 1 × 10<sup>9</sup> colony forming unit (CFU)/dog per day (which would correspond approximately to 3.5 × 10<sup>9</sup> CFU/kg complete feed).

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Publication Details

Journal
EFSA Journal
Published
2025-03-01
DOI
https://doi.org/10.2903/j.efsa.2025.9254
Primary Topic
Agricultural safety and regulations
Type
article
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article

Assessment of the efficacy of a feed additive consisting of Bifidobacterium longum CNCM I‐5642 (PP102I) for dogs (Nestlé Enterprises S.A.)

Giovanna Martelli, Ilen Röhe, Alena Pechová, Eleftherios Bonos et al.
EFSA Journal
Agricultural safety and regulations
article

Assessment of the efficacy of a feed additive consisting of Bifidobacterium longum CNCM I‐5642 (PP102I) for dogs (Nestlé Enterprises S.A.)

Giovanna Martelli, Ilen Röhe, Alena Pechová, Eleftherios Bonos, Henrik Christensen, Roberto Edoardo Villa, Katerina Theodoridou, Marta López‐Alonso, Francesca Marcon, Ronette Gehring, Jordi Ortuño, Carlo Nebbia, Miguel Prieto Maradona, Mojca Durjava, Maryline Kouba, Boet Glandorf, Giovanna Azimonti, Birgit Dusemund, Montserrat Anguita, Matteo L. Innocenti
article en

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of <i>Bifidobacterium longum</i> CNCM I-5642 (PP102I) as a zootechnical feed additive (functional group: physiological condition stabiliser) for dogs. In a previous opinion, the FEEDAP Panel concluded that PP102I was safe for dogs and the environment. Regarding the safety for the users, the Panel concluded that the additive should be considered a skin and respiratory sensitiser. Due to the lack of data, no conclusions could be drawn on the potential for skin/eye irritancy of the additive. Due to the lack of sufficient data, the Panel could not conclude on the efficacy of the additive for dogs at the proposed conditions of use. The applicant submitted in vitro eye and skin irritation tests and one efficacy trial in dogs to address the inconclusive aspects of the previous assessment. Based on the data provided, the Panel considers that the additive is irritant to the eyes but not to the skin. The additive has the potential to be efficacious when included in feed for dogs at 1 × 10<sup>9</sup> colony forming unit (CFU)/dog per day (which would correspond approximately to 3.5 × 10<sup>9</sup> CFU/kg complete feed).

EFSA JournalVol. 23(3)
Openalex Percentile: Top 95%
Agricultural safety and regulations
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