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评估PHYZYMEXP 10000 TPT/L(6-植酸酶)作为所有禽类和所有猪类饲料添加剂的授权续期申请。

Assessment of the application for renewal of the authorisation of PHYZYMEXP 10000 TPT/L (6-phytase) as a feed additive for all avian species and all swine species.

作者信息

Bampidis Vasileios, Azimonti Giovanna, de Lourdes Bastos Maria, Christensen Henrik, Dusemund Birgit, Kouba Maryline, Kos Durjava Mojca, López-Alonso Marta, López Puente Secundino, Marcon Francesca, Pechová Alena, Petkova Mariana, Ramos Fernando, Sanz Yolanda, Villa Roberto Edoardo, Woutersen Ruud, Anguita Montserrat, Pettenati Elisa, Mayo Baltasar

出版信息

EFSA J. 2019 May 10;17(5):e05702. doi: 10.2903/j.efsa.2019.5702. eCollection 2019 May.

Abstract

PHYZYME XP 10000 TPT/L is a feed additive that contains 6-phytase produced by a genetically modified strain of . The applicant requested for the renewal of the authorisation for PHYZYME XP 10000 TPT and L to be used as a feed additive for avian species for fattening/laying, weaned piglets, pigs for fattening and sows and for an extension of use to avian species reared for laying/breeding, suckling piglets and minor porcine species. To support the request or the renewal of the authorisation, the applicant provided evidence that the additive in the market complies with the conditions of the authorisation. According to the information provided by the applicant, no new evidence has been identified that would make the FEEDAP Panel reconsider the previous conclusions regarding the safety for the target species, consumer, user and environment. The application for renewal of the authorisation did not include a proposal for amending the conditions of use in those species for which an authorisation exists that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. Regarding the new species/categories, the Panel concluded that the additive is safe and has a potential to be efficacious in avian species reared for laying/breeding at 250 FTU/kg feed and for suckling piglets and minor porcine species at 500 FTU/kg feed.

摘要

植酸酶XP 10000 TPT/L是一种饲料添加剂,含有由转基因菌株生产的6-植酸酶。申请人请求延长植酸酶XP 10000 TPT/L作为育肥/产蛋禽类、断奶仔猪、育肥猪和母猪的饲料添加剂的授权,并将其使用范围扩大到产蛋/育种禽类、哺乳仔猪和小型猪种。为支持该请求或授权续期,申请人提供了市场上该添加剂符合授权条件的证据。根据申请人提供的信息,未发现新的证据使饲料添加剂和动物营养产品欧洲小组重新考虑先前关于目标物种、消费者、使用者和环境安全性的结论。授权续期申请未包括修改现有授权物种使用条件的提议,因为这会影响添加剂的功效。因此,在授权续期时无需评估添加剂的功效。关于新的物种/类别,该小组得出结论,该添加剂在产蛋/育种禽类饲料中添加250 FTU/kg、哺乳仔猪和小型猪种饲料中添加500 FTU/kg时是安全的,且有可能有效。

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