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通报号: G/SPS/N/EU/147
ICS号: 67
发布日期: 2015-10-16
截至日期: 2015-10-16
通报成员: 欧盟
目标和理由: 保障食品安全
内容概述: 本监管措施否决批准芽孢杆菌(Bacillustoyonensis)(NCIMB14858T)制备物作为育肥牛、兔、鸡、仔猪(断奶)、母猪、种公猪及饲养牛犊饲料添加剂的商业化销售。这是自2013年停止批准(2013年3月25日第(EC)288/2013号法规)后的一个决定性措施。 根据关于动物营养添加剂第(EC)1831/2003号法规，欧洲食品安全局(EFSA)对饲料添加剂蜡样芽孢杆菌toyoi变种(NCIMB40112/CNCMI-1012)("Toyocerin")进行了再评估(EUL268号官方公报,2003年10月18日,29页)。 2012年10月6日，欧洲食品安全局(EFSA)采纳了一条用Toyocerin作为饲料添加剂相关安全问题的意见。在此基础上，批准微生物毒性分类的申请人还就抗生素抗药性的可转移问题及微生物基因组存在的肠毒素基因功能性问题提交了补充数据。 经过对这些补充数据评估后，欧洲食品安全局(EFSA)于2014年7月1日采纳一项确认有关抗生素敏感性及添加剂潜在毒素安全问题的意见。 因此，在对人类和动物健康不利影响方面已不再符合批准饲料添加剂Toyocerin的监管条件。因此批准予以否决。 由于用含该制备物的预混合料及用该制备物生产的饲料和混合饲料配制成的蜡样芽孢杆菌toyoi变种(NCIMB40112/CNCMI-1012)目前还有存货，因此，根据第(EU)288/2013号执行法规第7条，直接将其从市场上撤回而不提供过渡性措施。
通报热点:食品和饲料添加剂问题
正文:
| 世界贸易组织 |
G/SPS/N/EU/147
2015-10-16
15-5429
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| 卫生及植物卫生措施委员会 |
原文：英文
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通 报
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通报成员: 欧盟
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负责机构:欧委会,健康食品安全总司
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覆盖的产品： 饲料添加剂：HS代码2309
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可能受影响的地区或国家：
[X] 所有贸易伙伴
[ ] 特定地区或国家
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通报标题： 2015年8月17日委员会第(EU)2015/1399号执行法规——关于否决批准芽孢杆菌(Bacillustoyonensis)(NCIMB14858T)制备物(原蜡样芽孢杆菌toyoi变种：NCIMB40112/CNCMI-1012)作为一种牛、兔、鸡、仔猪(断奶)、母猪、种公猪育肥及牛犊饲养的饲料添加剂；撤销批准蜡样芽孢杆菌toyoi变种：NCIMB40112/CNCMI-1012作为火鸡育肥、兔子繁殖饲料添加剂的使用许可；修改第(EC)256/2002号、(EC)1453/2004、(EC)255/2005及(EC)1200/2005号法规及撤销第(EC)166/2008、(EC)378/2009法规及第(EU)288/2013号执行法规(欧洲经济区相关文本):
语言：英法西班牙文 页数：各4页 链接网址：
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内容简述：本监管措施否决批准芽孢杆菌(Bacillus toyonensis) (NCIMB 14858T)制备物作为育肥牛、兔、鸡、仔猪(断奶)、母猪、种公猪及饲养牛犊饲料添加剂的商业化销售。这是自2013年停止批准(2013年3月25日第(EC)288/2013号法规)后的一个决定性措施。
根据关于动物营养添加剂第(EC)1831/2003号法规，欧洲食品安全局(EFSA)对饲料添加剂蜡样芽孢杆菌toyoi变种(NCIMB 40112/CNCM I-1012) ("Toyocerin ")进行了再评估 (EU L 268号官方公报, 2003年10月18日, 29页)。
2012年10月6日，欧洲食品安全局(EFSA)采纳了一条用Toyocerin 作为饲料添加剂相关安全问题的意见。在此基础上，批准微生物毒性分类的申请人还就抗生素抗药性的可转移问题及微生物基因组存在的肠毒素基因功能性问题提交了补充数据。
经过对这些补充数据评估后，欧洲食品安全局(EFSA)于2014年7月1日采纳一项确认有关抗生素敏感性及添加剂潜在毒素安全问题的意见。
因此，在对人类和动物健康不利影响方面已不再符合批准饲料添加剂Toyocerin 的监管条件。因此批准予以否决。
由于用含该制备物的预混合料及用该制备物生产的饲料和混合饲料配制成的蜡样芽孢杆菌toyoi变种(NCIMB 40112/CNCM I-1012)目前还有存货，因此，根据第(EU)288/2013号执行法规第7条，直接将其从市场上撤回而不提供过渡性措施。
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| 7. |
目标与理由:
[X] 食品安全
[ ] 动物健康
[ ] 植物保护
[ ] 保护国家免受有害生物的其它危害
[ ] 保护人类免受动/植物有害生物的危害
保护国家免受有害生物的其它危害:
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是否有相关国际标准？如有，指出标准:
[X] 食品法典委员会(例如：食品法典委员会标准或相关文件的名称或序号)
CAC/RCP54-2004—良好动物饲养实施规程；CAC/GL80-2013—饲料风险评估应用指南。
[ ] 世界动物卫生组织(OIE)(例如：陆生或水生动物卫生法典，章节号)
[ ] 国际植物保护公约(例如：ISPM N°)
[ ] 无
该法规草案是否符合相关国际标准： [X] 是 [ ]否
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拟批准日期:2015年8月17日
拟公布日期:2015年8月18日
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拟生效日期:
[ ] 通报日后6个月，及/或(年月日)： 2015年9月7日
[ ] 贸易促进措施
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意见反馈截止日期：
[ ] 通报发布日起60天，及/或(年/月/日): 不适用
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负责处理反馈意见的机构:
[X] 国家通报机构
[X] 国家咨询点，或其他机构的联系地址、传真及电子邮件地址(如能提供):
EuropeanCommission DGHealthandFoodSafety, UnitG6-MultilateralInternationalRelations RueFroissart101 B-1049Brussels Tel:+(322)2954263 Fax:+(322)2998090 E-mail:sps@ec.europa.eu
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文本可从以下机构得到:
[X] 国家通报机构
[X] 国家咨询点，或其他机构的联系地址、传真及电子邮件地址(如能提供):
EuropeanCommission DGHealthandFoodSafety, UnitG6-MultilateralInternationalRelations RueFroissart101 B-1049Brussels Tel:+(322)2954263 Fax:+(322)2998090 E-mail:sps@ec.europa.eu
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正文(英):
NOTIFICATION
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Notifying Member: European Union
If applicable, name of local government involved:
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Agency responsible: European Commission, Health and Food Safety Directorate-General
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Products covered (provide tariff item number(s) as specified in national schedules deposited with the WTO; ICS numbers should be provided in addition, where applicable): Feed additives included in HS code 2309
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Regions or countries likely to be affected, to the extent relevant or practicable:
[X] All trading partners
[ ] Specific regions or countries:
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Title of the notified document: Commission Implementing Regulation (EU) 2015/1399 of 17 August 2015 concerning the denial of authorisation of the preparation of Bacillus toyonensis (NCIMB 14858T) (formerly Bacillus cereus var. toyoi NCIMB 40112/CNCM I-1012) as a feed additive for cattle for fattening, rabbits for fattening, chickens for fattening, piglets (weaned), pigs for fattening, sows for reproduction and calves for rearing and the revocation of the authorisations of the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) as a feed additive for turkeys for fattening and rabbit breeding does, amending Regulations (EC) No 256/2002, (EC) No 1453/2004, (EC) No 255/2005 and (EC) No 1200/2005 and repealing Regulations (EC) No 166/2008, (EC) No 378/2009 and Implementing Regulation (EU) No 288/2013 (Text with EEA relevance) Language(s): English, French and Spanish Number of pages: 4
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Description of content: The regulatory measure denies the authorisation of commercialisation of the preparation Bacillus toyonensis (NCIMB 14858T) as a feed additive for use for cattle for fattening, rabbits for fattening, chickens for fattening, piglets (weaned), pigs for fattening, sows for reproduction and calves for rearing. This is a definitive measure, following a suspension of the authorisation issued in 2013 (Regulation (EC) 288/2013 of 25 March 2013).
The feed additive Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) ("Toyocerin?") was re-evaluated by the European Food Safety Authority (EFSA) under Regulation (EC) No 1831/2003 on additives for use in animal nutrition (Official Journal of the EU L 268, 18.10.2003, p. 29).
On 16 October 2012, EFSA adopted an opinion raising safety concerns about the use of Toyocerin? as feed additive. On that basis, supplementary data were submitted by the applicant for authorisation concerning essentially the taxonomic classification of the micro-organism, the issue of the transferability of the antibiotic resistance and the issue of the functionality of the enterotoxin genes present in the genome of the micro-organism.
After assessment of those supplementary data, EFSA adopted an opinion on 1 July 2014 which confirmed the safety concerns as regards antibiotic susceptibility and toxigenic potential of the additive.
Consequently, the regulatory conditions for authorisation of the feed additive Toyocerin? were no longer met as regards the absence of adverse effects on human and animal health. Therefore the authorisation had to be denied.
Since existing stocks of the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012), of premixtures containing that preparation and of feed materials and compound feed produced from that preparation were already to be withdrawn from the market according to Article 7 of Implementing Regulation (EU) No 288/2013, no transitional measures were provided for.
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Objective and rationale: [X] food safety, [ ] animal health, [ ] plant protection, [ ] protect humans from animal/plant pest or disease, [ ] protect territory from other damage from pests.
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Is there a relevant international standard? If so, identify the standard:
[X] Codex Alimentarius Commission (e.g. title or serial number of Codex standard or related text) Code of practice on Good Animal Feeding CAC/RCP 54-2004, Guidelines on the Application of Risk Assessment for Feed CAC/GL 80-2013
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic Animal Health Code, chapter number)
[ ] International Plant Protection Convention (e.g. ISPM number)
[ ] None
Does this proposed regulation conform to the relevant international standard?
[X] Yes [ ] No
If no, describe, whenever possible, how and why it deviates from the international standard:
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Other relevant documents and language(s) in which these are available:
- Commission Implementing Regulation (EU) No 288/2013 of 25 March 2013 concerning the suspension of the authorisation of the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) as provided for by Regulations (EC) No 256/2002, (EC) No 1453/2004, (EC) No 255/2005, (EC) No 1200/2005, (EC) No 166/2008 and (EC) No 378/2009 (Text with EEA relevance)
- EFSA Scientific Opinion on Toyocerin? (Bacillus cereus) as a feed additive for sows, piglets, pigs for fattening, cattle for fattening, calves for rearing, chickens for fattening and rabbits for fattening: http://www.efsa.europa.eu/en/efsajournal/pub/2924
- EFSA Scientific Opinion on the safety and efficacy of Toyocerin? (Bacillus toyonensis) as a feed additive for chickens for fattening, weaned piglets, pigs for fattening, sows for reproduction, cattle for fattening and calves for rearing and for rabbits for fattening: http://www.efsa.europa.eu/en/efsajournal/pub/3766
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Proposed date of adoption (dd/mm/yy): 17 August 2015
Proposed date of publication (dd/mm/yy): 18 August 2015
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Proposed date of entry into force: [ ] Six months from date of publication, and/or (dd/mm/yy): 7 September 2015
[ ] Trade facilitating measure
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Final date for comments: [ ] Sixty days from the date of circulation of the notification and/or (dd/mm/yy): Not applicable
Agency or authority designated to handle comments: [X] National Notification Authority, [X] National Enquiry Point. Address, fax number and e?mail address (if available) of other body:
European Commission
DG Health and Food Safety, Unit G6-Multilateral International Relations
Rue Froissart 101
B-1049 Brussels
Tel: +(32 2) 29 54263
Fax: +(32 2) 29 98090
E-mail: sps@ec.europa.eu
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13.
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Text(s) available from: [X] National Notification Authority, [X] National Enquiry Point. Address, fax number and e?mail address (if available) of other body:
European Commission
DG Health and Food Safety, Unit G6-Multilateral International Relations
Rue Froissart 101
B-1049 Brussels
Tel: +(32 2) 29 54263
Fax: +(32 2) 29 98090
E-mail: sps@ec.europa.eu
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