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阿维酶1505(内切-1,4-β-木聚糖酶、枯草杆菌蛋白酶和α-淀粉酶)对所有家禽品种的安全性和有效性。

Safety and efficacy of Avizyme 1505 (endo-1,4-beta-xylanase, subtilisin and alpha-amylase) for all poultry species.

作者信息

Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Kos 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, Cocconcelli Pier Sandro, Glandorf Boet, Herman Lieve, Maradona Miguel Prieto, Saarela Maria, Galobart Jaume, Holczknecht Orsolya, Manini Paola, Pizzo Fabiola, Tarrés-Call Jordi, Anguita Montserrat, Pettenati Elisa

出版信息

EFSA J. 2020 Feb 21;18(2):e06027. doi: 10.2903/j.efsa.2020.6027. eCollection 2020 Feb.

Abstract

Avizyme 1505 is based on three enzyme activities produced by three genetically modified microorganisms: xylanase, subtilisin and amylase produced by , and , respectively. It is authorised for use in chickens and turkeys for fattening, ducks and laying hens. This scientific opinion concerns the request for the renewal of the authorisation of the additive for the species/categories for which there is an authorisation, a reduction of the minimum recommended level in turkeys for fattening and the extension of use to all avian species for laying, for fattening, reared for breeding and reared for laying (except for ducks). Based on recent data, uncertainty remains in the characterisation of the production strains and the possible presence in the final product of viable production strains and their DNA. Therefore, the EFSA Panel on Additives and products or Substances used in Animal Feed (FEEDAP) could not confirm the conclusions previously drawn regarding the safety of Avizyme 1505 for the target species, consumers, users and environment. This conclusion applies also to the new target species for which a request for an extension of use is made. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation for chickens for fattening, ducks and laying hens. The efficacy data previously evaluated allowed the Panel to conclude that the additive has the potential to be efficacious at 187.5 U xylanase, 2,500 U subtilisin and 250 U amylase/kg complete feed for all avian species for fattening (including turkeys), reared for breeding and reared for laying and 300 U xylanase, 4,000 U subtilisin and 400 U amylase/kg complete feed in all avian species for laying.

摘要

阿维酶1505基于三种转基因微生物产生的三种酶活性:木聚糖酶、枯草杆菌蛋白酶和淀粉酶,分别由[具体微生物名称1]、[具体微生物名称2]和[具体微生物名称3]产生。它被批准用于肉鸡、育肥火鸡、鸭和蛋鸡。本科学意见涉及对该添加剂在已获授权的物种/类别中的授权续期申请,降低育肥火鸡的最低推荐水平,以及将使用范围扩大到所有产蛋、育肥、种用和蛋用禽类(鸭除外)。基于最新数据,生产菌株的特性以及最终产品中可能存在的活生产菌株及其DNA的情况仍存在不确定性。因此,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)无法确认先前就阿维酶1505对目标物种、消费者、使用者和环境的安全性得出的结论。这一结论也适用于提出使用范围扩大申请的新目标物种。在肉鸡、鸭和蛋鸡的授权续期背景下,无需评估该添加剂的功效。先前评估的功效数据使专家小组得出结论,该添加剂在187.5单位木聚糖酶、2500单位枯草杆菌蛋白酶和250单位淀粉酶/千克全价饲料的添加量下,对所有育肥禽类(包括火鸡)、种用和蛋用禽类可能有效;在300单位木聚糖酶、4000单位枯草杆菌蛋白酶和400单位淀粉酶/千克全价饲料的添加量下,对所有产蛋禽类可能有效。

相似文献

1
Safety and efficacy of Avizyme 1505 (endo-1,4-beta-xylanase, subtilisin and alpha-amylase) for all poultry species.
EFSA J. 2020 Feb 21;18(2):e06027. doi: 10.2903/j.efsa.2020.6027. eCollection 2020 Feb.

本文引用的文献

1
Guidance on the assessment of the efficacy of feed additives.
EFSA J. 2018 May 7;16(5):e05274. doi: 10.2903/j.efsa.2018.5274. eCollection 2018 May.
2
Guidance on the characterisation of microorganisms used as feed additives or as production organisms.
EFSA J. 2018 Mar 28;16(3):e05206. doi: 10.2903/j.efsa.2018.5206. eCollection 2018 Mar.
3
Guidance on the identity, characterisation and conditions of use of feed additives.
EFSA J. 2017 Oct 17;15(10):e05023. doi: 10.2903/j.efsa.2017.5023. eCollection 2017 Oct.
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EFSA J. 2017 Oct 17;15(10):e05022. doi: 10.2903/j.efsa.2017.5022. eCollection 2017 Oct.
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Guidance on the assessment of the safety of feed additives for the target species.
EFSA J. 2017 Oct 17;15(10):e05021. doi: 10.2903/j.efsa.2017.5021. eCollection 2017 Oct.

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