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一种由中国普通微生物菌种保藏管理中心7.371(VTR - 木聚糖酶)产生的内切-β-1,4 - 木聚糖酶组成的饲料添加剂对所有禽类、仔猪(哺乳和断奶)及小型生长猪种的安全性和有效性(胜利酶有限公司)

Safety and efficacy of a feed additive consisting of endo-β-1,4-xylanase produced by CGMCC 7.371 (VTR-xylanase) for all avian species, piglets (suckling and weaned) and minor growing porcine species (Victory Enzymes GmbH).

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, Sanz Yolanda, Villa Roberto Edoardo, Woutersen Ruud, Brantom Paul, Martelli Giovanna, Svensson Kettil, Anguita Montserrat, Brozzi Rosella, Galobart Jaume, Innocenti Matteo, Pettenati Elisa, Pizzo Fabiola, Tarrés-Call Jordi, Ortuño Jordi

出版信息

EFSA J. 2023 Aug 2;21(8):e08150. doi: 10.2903/j.efsa.2023.8150. eCollection 2023 Aug.

DOI:10.2903/j.efsa.2023.8150
PMID:37539080
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10394589/
Abstract

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of endo-β-1,4-xylanase (VTR-xylanase) as a zootechnical feed additive for all avian species, piglets (suckling and weaned) and minor growing porcine species. VTR-xylanase is available in a powder and a liquid form and is produced by a genetically modified strain of (CGMCC 7.371). The genetic modification of the production strain does not give rise to safety concerns. Viable cells of the production strain and its DNA were not detected in the final products. The additive does not pose any safety concern regarding the production strain. VTR xylanase (powder/liquid) produced by CGMCC 7.371 is safe for all avian species, piglets and minor growing porcine species at the proposed conditions of use. The use of both forms of the additive under assessment in animal nutrition under the proposed conditions of use raises no safety concerns for consumers or for the environment. The liquid and powder formulations of VTR-xylanase are non-irritant to eyes but should be considered skin sensitisers. No conclusions can be drawn on the potential of the final formulations of the additive to be irritant to skin. Due to the proteinaceous nature of the active substance, the additive is a respiratory sensitiser. The additive has the potential to be efficacious in all laying birds and piglets (suckling and weaned) from all at 2,000 U/kg and in all other avian species/categories at 1,000 U/kg feed.

摘要

应欧盟委员会的要求,欧洲食品安全局动物饲料添加剂和产品或物质专家小组(FEEDAP)被要求就内切-β-1,4-木聚糖酶(VTR-木聚糖酶)作为所有禽类、仔猪(哺乳和断奶)及小型生长猪的畜牧饲料添加剂的安全性和有效性发表科学意见。VTR-木聚糖酶有粉末和液体两种形式,由一种转基因的 (CGMCC 7.371)菌株生产。生产菌株的基因改造不存在安全问题。在最终产品中未检测到生产菌株的活细胞及其DNA。该添加剂对生产菌株不存在任何安全问题。由CGMCC 7.371生产的VTR木聚糖酶(粉末/液体)在建议的使用条件下对所有禽类、仔猪和小型生长猪是安全的。在建议的使用条件下,在动物营养中评估的两种形式的添加剂的使用对消费者或环境均不存在安全问题。VTR-木聚糖酶的液体和粉末制剂对眼睛无刺激性,但应被视为皮肤致敏剂。关于添加剂最终制剂对皮肤的潜在刺激性无法得出结论。由于活性物质的蛋白质性质,该添加剂是一种呼吸道致敏剂。该添加剂在所有产蛋鸡和所有 来源的仔猪(哺乳和断奶)中添加量为2000 U/kg时以及在所有其他禽类/类别中添加量为1000 U/kg饲料时有潜在的有效性。

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本文引用的文献

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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。
EFSA J. 2019 Apr 5;17(4):e05648. doi: 10.2903/j.efsa.2019.5648. eCollection 2019 Apr.
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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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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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EFSA J. 2017 Oct 17;15(10):e05023. doi: 10.2903/j.efsa.2017.5023. eCollection 2017 Oct.
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