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DSM 34663(Hostazym® X)生产的内切-1,4-β-木聚糖酶饲料添加剂用于所有家禽品种、观赏鸟类、所有生长阶段的鱼类及鲤鱼(Huvepharma NV)的安全性和有效性。

Safety and efficacy of a feed additive consisting of endo-1,4-β-xylanase produced by DSM 34663 (Hostazym® X) for use in all poultry species, ornamental birds, all growing and carp (Huvepharma NV).

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, Tosti Luca, Anguita Montserrat, Galobart Jaume, Innocenti Matteo, Pettenati Elisa, Ortuño Jordi

出版信息

EFSA J. 2023 Aug 4;21(8):e08171. doi: 10.2903/j.efsa.2023.8171. eCollection 2023 Aug.

DOI:10.2903/j.efsa.2023.8171
PMID:37547225
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10401331/
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 a feed additive containing endo-1,4-β-xylanase produced by DSM 34663 (Hostazym® X). The product is authorised as a zootechnical additive (digestibility enhancers) for use in all poultry species for fattening, for laying and reared for laying, weaned piglets, pigs for fattening and carp. The current opinion concerns the request for the renewal of the authorisation for the use in those species/categories and the extension of use to all poultry species for breeding and reared for breeding, ornamental birds, suckling piglets and minor porcine species for fattening. The applicant provided evidence that the additive in the market complies with the conditions of the authorisation. There is no new evidence that would lead the Panel to reconsider previous conclusions that the additive is safe for the target species, the consumers and the environment under the authorised conditions of use. This conclusion also applies to the target species for which a request for extension of use is made. The additive is considered not a skin corrosive or skin sensitiser, but it is an eye irritant. The Panel cannot conclude on the potential of the additive to be a skin irritant. Due to the proteinaceous nature of the active substance, the additive is considered a respiratory sensitiser. The Panel considers that the additive has the potential to be efficacious in all poultry species, ornamental birds, all growing and carp at the proposed conditions of use.

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)被要求就一种含有由DSM 34663生产的内切-1,4-β-木聚糖酶的饲料添加剂(Hostazym® X)的安全性和有效性发表科学意见。该产品被授权作为一种畜牧技术添加剂(消化促进剂),用于所有育肥、产蛋和后备产蛋的家禽品种、断奶仔猪、育肥猪和鲤鱼。本次意见涉及在这些物种/类别中使用的授权续期申请,以及将使用范围扩大到所有育种和后备育种的家禽品种、观赏鸟、哺乳仔猪和育肥的小型猪品种的申请。申请人提供了市场上该添加剂符合授权条件的证据。没有新的证据会导致专家小组重新考虑先前的结论,即在授权使用条件下,该添加剂对目标物种、消费者和环境是安全的。这一结论也适用于提出使用范围扩大申请的目标物种。该添加剂不被认为是皮肤腐蚀剂或皮肤致敏剂,但它是一种眼刺激物。专家小组无法就该添加剂成为皮肤刺激物的可能性得出结论。由于活性物质的蛋白质性质,该添加剂被认为是一种呼吸道致敏剂。专家小组认为,在所提议的使用条件下,该添加剂对所有家禽品种、观赏鸟、所有生长阶段的猪和鲤鱼都有潜在的有效性。

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Safety and efficacy of a feed additive consisting of endo-1,4-β-xylanase produced by DSM 34663 (Hostazym® X) for use in all poultry species, ornamental birds, all growing and carp (Huvepharma NV).DSM 34663(Hostazym® X)生产的内切-1,4-β-木聚糖酶饲料添加剂用于所有家禽品种、观赏鸟类、所有生长阶段的鱼类及鲤鱼(Huvepharma NV)的安全性和有效性。
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本文引用的文献

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Efficacy of a feed additive consisting of endo-1,4-beta-xylanase produced by (IMI SD 135) (HOSTAZYM X) for sows in order to have benefits in piglets (Huvepharma NV).由(IMI SD 135)(HOSTAZYM X)产生的内切-1,4-β-木聚糖酶组成的饲料添加剂对母猪的功效,以便对仔猪产生益处(Huvepharma NV)。
EFSA J. 2022 Mar 3;20(3):e07154. doi: 10.2903/j.efsa.2022.7154. eCollection 2022 Mar.
2
Safety and efficacy of FRA Octazyme C Dry (endo-1,4-β-xylanase, mannan-endo-1,4-β-mannosidase, α-amylase, endo-1,3(4)-β-glucanase, pectinase, endo-1,4-β-glucanase, protease, α-galactosidase) as a feed additive for weaned piglets and chickens for fattening.FRA Octazyme C Dry(内切-1,4-β-木聚糖酶、甘露聚糖内切-1,4-β-甘露糖苷酶、α-淀粉酶、内切-1,3(4)-β-葡聚糖酶、果胶酶、内切-1,4-β-葡聚糖酶、蛋白酶、α-半乳糖苷酶)作为断奶仔猪和育肥鸡饲料添加剂的安全性和有效性。
EFSA J. 2019 Jun 18;17(6):e05730. doi: 10.2903/j.efsa.2019.5730. eCollection 2019 Jun.
3
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.
4
Guidance on the assessment of the efficacy of feed additives.饲料添加剂功效评估指南。
EFSA J. 2018 May 7;16(5):e05274. doi: 10.2903/j.efsa.2018.5274. eCollection 2018 May.
5
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。
EFSA J. 2018 Mar 28;16(3):e05206. doi: 10.2903/j.efsa.2018.5206. eCollection 2018 Mar.
6
Safety and efficacy of Hostazym X (endo-1,4-beta-xylanase) as a feed additive for sows in order to have benefit in piglets.Hostazym X(内切-1,4-β-木聚糖酶)作为母猪饲料添加剂以造福仔猪的安全性和有效性。
EFSA J. 2018 Oct 23;16(10):e05456. doi: 10.2903/j.efsa.2018.5456. eCollection 2018 Oct.
7
Safety and efficacy of FRA Octazyme C Dry (α-galactosidase, α-amylase, endo-1,3(4)-β-glucanase, endo-1,4-β-glucanase, mannan-endo-1,4-β-mannosidase, pectinase, protease, endo-1,4-β-xylanase) for chickens for fattening and weaned piglets.FRA Octazyme C Dry(α-半乳糖苷酶、α-淀粉酶、内切-1,3(4)-β-葡聚糖酶、内切-1,4-β-葡聚糖酶、甘露聚糖内切-1,4-β-甘露糖苷酶、果胶酶、蛋白酶、内切-1,4-β-木聚糖酶)对育肥鸡和断奶仔猪的安全性及有效性
EFSA J. 2017 Aug 2;15(8):e04943. doi: 10.2903/j.efsa.2017.4943. eCollection 2017 Aug.
8
Safety and efficacy of HOSTAZYM X (endo-1,4-β-xylanase) as a feed additive for chickens reared for laying and minor poultry species reared for laying.HOSTAZYM X(内切-1,4-β-木聚糖酶)作为蛋鸡和小型蛋用家禽饲料添加剂的安全性和有效性。
EFSA J. 2017 Feb 8;15(2):e04708. doi: 10.2903/j.efsa.2017.4708. eCollection 2017 Feb.
9
Guidance on the identity, characterisation and conditions of use of feed additives.饲料添加剂的标识、特性及使用条件指南。
EFSA J. 2017 Oct 17;15(10):e05023. doi: 10.2903/j.efsa.2017.5023. eCollection 2017 Oct.
10
Guidance on the assessment of the safety of feed additives for the target species.目标物种饲料添加剂安全性评估指南。
EFSA J. 2017 Oct 17;15(10):e05021. doi: 10.2903/j.efsa.2017.5021. eCollection 2017 Oct.