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通報號: G/SPS/N/EU/147
ICS號: 67
發布日期: 2015-10-16
截至日期: 2015-10-16
通報成員: 歐盟
目標和理由: 保障食品安全
內容概述: 本監管措施否決批準芽孢桿菌(Bacillustoyonensis)(NCIMB14858T)制備物作為育肥牛、兔、雞、仔豬(斷奶)、母豬、種公豬及飼養牛犢飼料添加劑的商業化銷售。這是自2013年停止批準(2013年3月25日第(EC)288/2013號法規)后的一個決定性措施。 根據關于動物營養添加劑第(EC)1831/2003號法規，歐洲食品安全局(EFSA)對飼料添加劑蠟樣芽孢桿菌toyoi變種(NCIMB40112/CNCMI-1012)("Toyocerin")進行了再評估(EUL268號官方公報,2003年10月18日,29頁)。 2012年10月6日，歐洲食品安全局(EFSA)采納了一條用Toyocerin作為飼料添加劑相關安全問題的意見。在此基礎上，批準微生物毒性分類的申請人還就抗生素抗藥性的可轉移問題及微生物基因組存在的腸毒素基因功能性問題提交了補充數據。 經過對這些補充數據評估后，歐洲食品安全局(EFSA)于2014年7月1日采納一項確認有關抗生素敏感性及添加劑潛在毒素安全問題的意見。 因此，在對人類和動物健康不利影響方面已不再符合批準飼料添加劑Toyocerin的監管條件。因此批準予以否決。 由于用含該制備物的預混合料及用該制備物生產的飼料和混合飼料配制成的蠟樣芽孢桿菌toyoi變種(NCIMB40112/CNCMI-1012)目前還有存貨，因此，根據第(EU)288/2013號執行法規第7條，直接將其從市場上撤回而不提供過渡性措施。
通報熱點:食品和飼料添加劑問題
正文:
| 世界貿易組織 |
G/SPS/N/EU/147
2015-10-16
15-5429
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| 衛生及植物衛生措施委員會 |
原文：英文
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通 報
| 1. |
通報成員: 歐盟
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| 2. |
負責機構:歐委會,健康食品安全總司
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| 3. |
覆蓋的產品： 飼料添加劑：HS代碼2309
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| 4. |
可能受影響的地區或國家：
[X] 所有貿易伙伴
[ ] 特定地區或國家
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| 5. |
通報標題： 2015年8月17日委員會第(EU)2015/1399號執行法規——關于否決批準芽孢桿菌(Bacillustoyonensis)(NCIMB14858T)制備物(原蠟樣芽孢桿菌toyoi變種：NCIMB40112/CNCMI-1012)作為一種牛、兔、雞、仔豬(斷奶)、母豬、種公豬育肥及牛犢飼養的飼料添加劑；撤銷批準蠟樣芽孢桿菌toyoi變種：NCIMB40112/CNCMI-1012作為火雞育肥、兔子繁殖飼料添加劑的使用許可；修改第(EC)256/2002號、(EC)1453/2004、(EC)255/2005及(EC)1200/2005號法規及撤銷第(EC)166/2008、(EC)378/2009法規及第(EU)288/2013號執行法規(歐洲經濟區相關文本):
語言：英法西班牙文 頁數：各4頁 鏈接網址：
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| 6. |
內容簡述：本監管措施否決批準芽孢桿菌(Bacillus toyonensis) (NCIMB 14858T)制備物作為育肥牛、兔、雞、仔豬(斷奶)、母豬、種公豬及飼養牛犢飼料添加劑的商業化銷售。這是自2013年停止批準(2013年3月25日第(EC)288/2013號法規)后的一個決定性措施。
根據關于動物營養添加劑第(EC)1831/2003號法規，歐洲食品安全局(EFSA)對飼料添加劑蠟樣芽孢桿菌toyoi變種(NCIMB 40112/CNCM I-1012) ("Toyocerin ")進行了再評估 (EU L 268號官方公報, 2003年10月18日, 29頁)。
2012年10月6日，歐洲食品安全局(EFSA)采納了一條用Toyocerin 作為飼料添加劑相關安全問題的意見。在此基礎上，批準微生物毒性分類的申請人還就抗生素抗藥性的可轉移問題及微生物基因組存在的腸毒素基因功能性問題提交了補充數據。
經過對這些補充數據評估后，歐洲食品安全局(EFSA)于2014年7月1日采納一項確認有關抗生素敏感性及添加劑潛在毒素安全問題的意見。
因此，在對人類和動物健康不利影響方面已不再符合批準飼料添加劑Toyocerin 的監管條件。因此批準予以否決。
由于用含該制備物的預混合料及用該制備物生產的飼料和混合飼料配制成的蠟樣芽孢桿菌toyoi變種(NCIMB 40112/CNCM I-1012)目前還有存貨，因此，根據第(EU)288/2013號執行法規第7條，直接將其從市場上撤回而不提供過渡性措施。
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| 7. |
目標與理由:
[X] 食品安全
[ ] 動物健康
[ ] 植物保護
[ ] 保護國家免受有害生物的其它危害
[ ] 保護人類免受動/植物有害生物的危害
保護國家免受有害生物的其它危害:
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| 8. |
是否有相關國際標準？如有，指出標準:
[X] 食品法典委員會(例如：食品法典委員會標準或相關文件的名稱或序號)
CAC/RCP54-2004—良好動物飼養實施規程；CAC/GL80-2013—飼料風險評估應用指南。
[ ] 世界動物衛生組織(OIE)(例如：陸生或水生動物衛生法典，章節號)
[ ] 國際植物保護公約(例如：ISPM N°)
[ ] 無
該法規草案是否符合相關國際標準： [X] 是 [ ]否
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| 9. |
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| 10. |
擬批準日期:2015年8月17日
擬公布日期:2015年8月18日
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| 11. |
擬生效日期:
[ ] 通報日后6個月，及/或(年月日)： 2015年9月7日
[ ] 貿易促進措施
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| 12. |
意見反饋截止日期：
[ ] 通報發布日起60天，及/或(年/月/日): 不適用
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| 13. |
負責處理反饋意見的機構:
[X] 國家通報機構
[X] 國家咨詢點，或其他機構的聯系地址、傳真及電子郵件地址(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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| 14. |
文本可從以下機構得到:
[X] 國家通報機構
[X] 國家咨詢點，或其他機構的聯系地址、傳真及電子郵件地址(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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1.
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Notifying Member: European Union
If applicable, name of local government involved:
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2.
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Agency responsible: European Commission, Health and Food Safety Directorate-General
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3.
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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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4.
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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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5.
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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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6.
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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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7.
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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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9.
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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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10.
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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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11.
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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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