TY - JOUR
T1 - Assessment of the efficacy of a feed additive consisting of Bifidobacterium longum CNCM I-5642 (PP102I) for dogs (Nestlé Enterprises S.A.)
AU - EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
AU - Villa, Roberto Edoardo
AU - Azimonti, Giovanna
AU - Bonos, Eleftherios
AU - Christensen, Henrik
AU - Durjava, Mojca
AU - Dusemund, Birgit
AU - Gehring, Ronette
AU - Glandorf, Boet
AU - Kouba, Maryline
AU - López-Alonso, Marta
AU - Marcon, Francesca
AU - Nebbia, Carlo
AU - Pechová, Alena
AU - Prieto-Maradona, Miguel
AU - Röhe, Ilen
AU - Theodoridou, Katerina
AU - Martelli, Giovanna
AU - Anguita, Montserrat
AU - Innocenti, Matteo L
AU - Ortuño, Jordi
N1 - © 2025 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.
PY - 2025/3
Y1 - 2025/3
N2 - Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of Bifidobacterium longum 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 × 109 colony forming unit (CFU)/dog per day (which would correspond approximately to 3.5 × 109 CFU/kg complete feed).
AB - Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of Bifidobacterium longum 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 × 109 colony forming unit (CFU)/dog per day (which would correspond approximately to 3.5 × 109 CFU/kg complete feed).
KW - Bifidobacterium longum CNCM I-5642
KW - PP102I
KW - efficacy
KW - physiological condition stabiliser
KW - user safety
KW - zootechnical additives
U2 - 10.2903/j.efsa.2025.9254
DO - 10.2903/j.efsa.2025.9254
M3 - Article
C2 - 40066209
SN - 1831-4732
VL - 23
JO - EFSA Journal
JF - EFSA Journal
IS - 3
M1 - e9254
ER -