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评估由美国典型培养物保藏中心PTA-6737(PB6)组成的饲料添加剂,以更新其对蛋鸡和小型产蛋家禽的授权(4b1823),并将其使用范围扩大到其他产蛋/种禽(科美欧公司)。

Assessment of the feed additive consisting of ATCC PTA-6737 (PB6) for the renewal of its authorisation for laying hens and minor poultry species for laying (4b1823) and its extension of use to other laying/breeding birds (Kemin Europa n.v.).

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, Anguita Montserrat, Galobart Jaume, Innocenti Matteo L, Ortuño Jordi, Pizzo Fabiola, Brozzi Rosella

出版信息

EFSA J. 2025 May 28;23(5):e9457. doi: 10.2903/j.efsa.2025.9457. eCollection 2025 May.

DOI:10.2903/j.efsa.2025.9457
PMID:40438197
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12117905/
Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of ATCC PTA-6737 (PB6) as a zootechnical feed additive. With the current application, the applicant is seeking the renewal of the authorisation for laying hens and minor poultry species for laying. In addition, the applicant is seeking the modification of the terms of the existing authorisation to obtain the authorisation of a more concentrated form of the additive (from 1 × 10 to 8 × 10 colony forming units (CFU)) and the authorisation of the additive for other birds kept for egg production or breeding. The evidence provided showed that the additive complies with the new specifications and the current terms of the authorisation. The FEEDAP Panel concludes that the additive is safe for laying hens, birds kept for egg production or breeding, the consumer and the environment. Regarding safety for the user, the additive is not irritant to the skin and eyes but should be considered a skin and respiratory sensitiser and inhalation and dermal exposure is considered a risk. The additive has the potential to be efficacious in other birds kept for egg production or breeding at the minimum inclusion level of 1 × 10 CFU/kg complete feed.

摘要

应欧盟委员会的要求,欧洲食品安全局(EFSA)被要求就一种由ATCC PTA - 6737(PB6)组成的饲料添加剂作为动物营养饲料添加剂的安全性和有效性发表科学意见。在本次申请中,申请人寻求更新蛋鸡和小型产蛋家禽品种的授权。此外,申请人正在寻求修改现有授权条款,以获得一种更浓缩形式添加剂(从1×10到8×10菌落形成单位(CFU))的授权,以及该添加剂用于其他用于产蛋或繁殖的禽类的授权。所提供的证据表明,该添加剂符合新规范和当前授权条款。饲料添加剂和动物营养产品专家小组得出结论,该添加剂对蛋鸡、用于产蛋或繁殖的禽类、消费者和环境是安全的。关于对使用者的安全性,该添加剂对皮肤和眼睛无刺激性,但应被视为皮肤和呼吸道致敏剂,吸入和皮肤接触被视为有风险。该添加剂在其他用于产蛋或繁殖的禽类中,以最低添加水平1×10 CFU/kg全价饲料使用时,具有有效的可能性。

相似文献

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Assessment of the feed additive consisting of ATCC PTA-6737 (PB6) for the renewal of its authorisation for laying hens and minor poultry species for laying (4b1823) and its extension of use to other laying/breeding birds (Kemin Europa n.v.).评估由美国典型培养物保藏中心PTA-6737(PB6)组成的饲料添加剂,以更新其对蛋鸡和小型产蛋家禽的授权(4b1823),并将其使用范围扩大到其他产蛋/种禽(科美欧公司)。
EFSA J. 2025 May 28;23(5):e9457. doi: 10.2903/j.efsa.2025.9457. eCollection 2025 May.
2
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本文引用的文献

1
EFSA statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain.欧洲食品安全局关于食物链中有意使用的微生物全基因组序列分析要求的声明。
EFSA J. 2024 Aug 12;22(8):e8912. doi: 10.2903/j.efsa.2024.8912. eCollection 2024 Aug.
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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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Assessment of the feed additive consisting of ATCC PTA-6737 (PB6) for turkeys for fattening and turkeys reared for breeding for the renewal of its authorisation and the modification of the conditions of the authorisation for other growing poultry species (Kemin Europe N.V).对由美国典型培养物保藏中心PTA-6737(PB6)组成的饲料添加剂进行评估,该添加剂用于育肥火鸡和种用火鸡,以更新其授权并修改其他生长家禽品种的授权条件(科美公司)。
EFSA J. 2024 Mar 4;22(3):e8650. doi: 10.2903/j.efsa.2024.8650. eCollection 2024 Mar.
4
Safety and efficacy of a feed additive consisting of  ATCC PTA-6737 (PB6) for the renewal of the authorisations in weaned piglets, weaned minor porcine species and sows and the extension of use to all (Kemin Europe N.V).一种由ATCC PTA - 6737(PB6)组成的饲料添加剂用于断奶仔猪、断奶小型猪种和母猪重新授权以及扩大至所有猪使用(科美公司)的安全性和有效性。
EFSA J. 2024 Feb 26;22(2):e8562. doi: 10.2903/j.efsa.2024.8562. eCollection 2024 Feb.
5
Guidance on the assessment of the safety of feed additives for the users.饲料添加剂使用者安全评估指南。
EFSA J. 2023 Dec 6;21(12):e8469. doi: 10.2903/j.efsa.2023.8469. eCollection 2023 Dec.
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Statement on how to interpret the QPS qualification on 'acquired antimicrobial resistance genes'.关于如何解读“获得性抗菌药物耐药基因”的QPS资质的声明
EFSA J. 2023 Oct 31;21(10):e08323. doi: 10.2903/j.efsa.2023.8323. eCollection 2023 Oct.
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Safety and efficacy of a feed additive consisting of ATCC PTA-6737 ( PB6) for turkeys for fattening, turkeys reared for breeding, laying hens, minor poultry species for laying, piglets (weaned), weaned minor porcine species and sows (Kemin Europe N.V.).一种由ATCC PTA - 6737(PB6)组成的饲料添加剂对育肥火鸡、种用火鸡、产蛋母鸡、小型产蛋家禽、仔猪(断奶)、断奶小型猪种和母猪的安全性和有效性(凯明欧洲公司)
EFSA J. 2022 Apr 13;20(4):e07244. doi: 10.2903/j.efsa.2022.7244. eCollection 2022 Apr.
8
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.
9
Safety and efficacy of PB6 (ATCC PTA-6737) as a feed additive for chickens for fattening, chickens reared for laying, minor poultry species (except for laying purposes), ornamental, sporting and game birds.PB6(美国典型培养物保藏中心PTA-6737)作为育肥鸡、产蛋鸡、小型家禽品种(产蛋用途除外)、观赏鸟、运动用鸟和猎鸟饲料添加剂的安全性和有效性。
EFSA J. 2020 Nov 10;18(11):e06280. doi: 10.2903/j.efsa.2020.6280. eCollection 2020 Nov.
10
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.