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

IF 3.3 3区 农林科学 Q2 FOOD SCIENCE & TECHNOLOGY
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Giovanna Martelli, Montserrat Anguita, Matteo L. Innocenti, Jordi Ortuño
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Abstract

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).

含有长双歧杆菌CNCM I-5642 (PP102I)的饲料添加剂对狗的功效评估(雀巢公司)
应欧盟委员会的要求,欧洲食品安全局被要求就长双歧杆菌CNCM I-5642 (PP102I)作为犬用动物饲料添加剂(功能组:生理状态稳定剂)的功效发表科学意见。在之前的意见中,FEEDAP小组得出结论,PP102I对狗和环境是安全的。至于对使用者的安全性,小组的结论是,该添加剂应被视为皮肤和呼吸道致敏剂。由于缺乏数据,无法得出关于添加剂对皮肤/眼睛刺激的潜在结论。由于缺乏足够的数据,专家小组无法就拟议使用条件下添加剂对狗的功效得出结论。申请人提交了体外眼睛和皮肤刺激试验以及一项狗功效试验,以解决先前评估的不确定方面。根据所提供的数据,小组认为该添加剂对眼睛有刺激性,但对皮肤没有刺激性。如果将该添加剂添加到狗饲料中,每天每只狗1 × 109菌落形成单位(CFU)(约相当于3.5 × 109 CFU/kg全饲料),则可能有效。
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来源期刊
EFSA Journal
EFSA Journal Veterinary-Veterinary (miscellaneous)
CiteScore
5.20
自引率
21.20%
发文量
422
审稿时长
5 weeks
期刊介绍: The EFSA Journal covers methods of risk assessment, reports on data collected, and risk assessments in the individual areas of plant health, plant protection products and their residues, genetically modified organisms, additives and products or substances used in animal feed, animal health and welfare, biological hazards including BSE/TSE, contaminants in the food chain, food contact materials, enzymes, flavourings and processing aids, food additives and nutrient sources added to food, dietetic products, nutrition and allergies.
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