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由NCAIM(P)Y001485生产的伏马菌素酯酶组成的饲料添加剂对所有猪(仔猪、育肥猪、母猪以及小型生长和繁殖猪种)的安全性和有效性(Bata博士有限公司)

Safety and efficacy of a feed additive consisting of fumonisin esterase produced with  NCAIM (P) Y001485 for all pigs (piglets, pigs for fattening, sows and minor growing and reproductive porcine species) (Dr. Bata Ltd.).

作者信息

Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Durjava Mojca, Kouba Maryline, López-Alonso Marta, López Puente Secundino, Marcon Francesca, Mayo Baltasar, Pechová Alena, Petkova Mariana, Ramos Fernando, Villa Roberto Edoardo, Woutersen Ruud, Martelli Giovanna, Brozzi Rosella, Galobart Jaume, Innocenti Matteo Lorenzo, Ortuño Jordi, Pettenati Elisa, Pizzo Fabiola, Tarrés-Call Jordi, Vettori Maria Vittoria, Radovnikovic Anita

出版信息

EFSA J. 2024 Mar 8;22(3):e8614. doi: 10.2903/j.efsa.2024.8614. eCollection 2024 Mar.

DOI:10.2903/j.efsa.2024.8614
PMID:38464413
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10921364/
Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the additive based on fumonisin esterase (Free Yeast® F), produced with a genetically modified strain of The additive is categorised as a technological feed additive, for the reduction of the contamination of feed by mycotoxins and intended for use in all pigs species (piglets, pigs for fattening, sows and minor growing and reproductive porcine species). It was shown that the production strain and its recombinant genes are not present in the additive. The FEEDAP Panel concluded that the additive is safe for weaned and suckling piglets and pigs for fattening, and all minor growing porcine species up to 60 U/kg complete feed. No conclusions can be drawn on the safety of the additive in sows. The use of the additive in animal nutrition is of no concern for consumer safety. The additive is dust-free, and therefore, respiratory sensitisation/irritation is unlikely. The additive is non-irritant to the eyes and the skin. No conclusion could be made on skin sensitisation. The use of the additive as a feed additive is considered safe for the environment. The Panel concluded that the additive is efficacious as technological feed additive for the reduction of feed contamination by fumonisins, when used at the minimum recommended concentration of 60 U/kg. This conclusion can be extrapolated to all growing and reproductive pigs and other minor porcine species.

摘要

应欧盟委员会要求,欧洲食品安全局(EFSA)被要求就基于伏马菌素酯酶(Free Yeast® F)的添加剂的安全性和有效性发表科学意见,该添加剂由一种转基因菌株生产。该添加剂被归类为一种饲料技术添加剂,用于减少饲料中霉菌毒素的污染,适用于所有猪种(仔猪、育肥猪、母猪以及其他小型生长和繁殖猪种)。结果表明,生产菌株及其重组基因不存在于该添加剂中。饲料添加剂和动物营养产品(FEEDAP)专家小组得出结论,该添加剂对断奶仔猪、哺乳仔猪、育肥猪以及体重达60 U/kg全价饲料的所有小型生长猪种是安全的。关于该添加剂对母猪的安全性无法得出结论。该添加剂在动物营养中的使用对消费者安全无影响。该添加剂无粉尘,因此不太可能引起呼吸道过敏/刺激。该添加剂对眼睛和皮肤无刺激性。关于皮肤致敏性无法得出结论。该添加剂作为饲料添加剂的使用被认为对环境是安全的。专家小组得出结论,当以最低推荐浓度60 U/kg使用时,该添加剂作为饲料技术添加剂对于减少伏马菌素对饲料的污染是有效的。这一结论可外推至所有生长猪和繁殖猪以及其他小型猪种。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc39/10921364/d7b1b36ed1f7/EFS2-22-e8614-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc39/10921364/d7b1b36ed1f7/EFS2-22-e8614-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc39/10921364/d7b1b36ed1f7/EFS2-22-e8614-g001.jpg

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本文引用的文献

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Safety and efficacy of fumonisin esterase from DSM 32159 as a feed additive for all animal species.DSM 32159来源的伏马菌素酯酶作为所有动物物种饲料添加剂的安全性和有效性。
EFSA J. 2020 Jul 20;18(7):e06207. doi: 10.2903/j.efsa.2020.6207. eCollection 2020 Jul.
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Guidance on the assessment of the safety of feed additives for the environment.饲料添加剂对环境安全性的评估指南。
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Guidance on the assessment of the efficacy of feed additives.饲料添加剂功效评估指南。
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Safety and efficacy of fumonisin esterase from DSM 32159 as a technological feed additive for pigs and poultry.DSM 32159 中伏马菌素酯酶作为猪和家禽的饲料添加剂的安全性和有效性。
EFSA J. 2018 May 17;16(5):e05269. doi: 10.2903/j.efsa.2018.5269. eCollection 2018 May.
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Guidance on the characterisation of microorganisms used as feed additives or as production organisms.用作饲料添加剂或生产生物的微生物特性鉴定指南。
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Appropriateness to set a group health-based guidance value for fumonisins and their modified forms.设定伏马菌素及其修饰形式基于群体健康的指导值是否合适。
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