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对由DSM 7134(博维特®)组成的母猪饲料添加剂进行重新授权评估(Lactosan有限公司)。

Assessment of the feed additive consisting of DSM 7134 (Bonvital®) for sows for the renewal of its authorisation (Lactosan GmbH & Co.KG).

作者信息

Villa Roberto Edoardo, Azimonti Giovanna, Bonos Eleftherios, Christensen Henrik, Durjava Mojca, Dusemund Birgit, Gehring Ronette, Glandorf Boet, Kouba Maryline, López-Alonso Marta, Marcon Francesca, Nebbia Carlo, Pechová Alena, Prieto-Maradona Miguel, Röhe Ilen, Theodoridou Katerina, Cocconcelli Pier Sandro, Anguita Montserrat, Galobart Jaume, Innocenti Matteo L, Brozzi Rosella

出版信息

EFSA J. 2025 Apr 16;23(4):e9353. doi: 10.2903/j.efsa.2025.9353. eCollection 2025 Apr.

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of Bonvital® as a zootechnical additive for sows. Bonvital® is currently authorised for use in weaned piglets, pigs for fattening, sows, chickens for fattening, laying hens, chickens reared for laying and minor poultry species (other than those used for laying). The active agent of Bonvital® was originally identified as . In a previous opinion the strain was reassigned to . The applicant provided evidence that the additive currently on the market complies with the existing terms of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for the target species, consumers and the environment under the authorised conditions of use. Bonvital® in its powder form is not irritant to the skin and eyes but no conclusion is possible for the granulated form. Bonvital® should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. There is no need to assess the efficacy of Bonvital® in the context of the renewal of the authorisation.

摘要

应欧盟委员会的要求,欧洲食品安全局(EFSA)被要求就Bonvital®作为母猪畜牧学添加剂授权续展申请的评估发表科学意见。Bonvital®目前被授权用于断奶仔猪、育肥猪、母猪、育肥鸡、产蛋鸡、种鸡以及小型家禽品种(不包括用于产蛋的品种)。Bonvital®的活性成分最初被鉴定为 。在之前的一份意见中,该菌株被重新归类为 。申请人提供了证据,证明目前市场上的添加剂符合现有授权条款。没有新的证据会使饲料添加剂和动物产品委员会重新考虑其先前的结论。因此,委员会得出结论,在授权的使用条件下,该添加剂对目标物种、消费者和环境仍然是安全的。Bonvital®粉末形式对皮肤和眼睛无刺激性,但对于颗粒形式无法得出结论。Bonvital®应被视为皮肤和呼吸道致敏剂,通过皮肤和呼吸道的任何接触都被视为有风险。在授权续展的背景下,无需评估Bonvital®的功效。

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Guidance on the renewal of the authorisation of feed additives.饲料添加剂授权续期指南。
EFSA J. 2021 Jan 7;19(1):e06340. doi: 10.2903/j.efsa.2021.6340. eCollection 2021 Jan.

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