G/SPS/N/EU/147  
 
16 October 2015  
(15-5429)  Page: 1/3  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION 
1. Notifying Member: EUROPEAN UNION 
If applicable, name of local government involved:   
2. Agency responsible: European Commission, Health and Food Safety Directorate-
General 
3. Products covered (provide tariff item  number(s) as specified in national 
schedules deposited with the WTO; IC S numbers should be provided in 
addition, where applicable): Feed additives included in HS code 2309 
4. Regions or countries likely to be affected , to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:   
5. 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 14858
T) (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 
http://members.wto.org/crnattachments/2015/SPS/EEC/15_4124_00_e.pdf  
http://members.wto.org/crnattachments/2015/SPS/EEC/15_4124_00_f.pdf  
http://members.wto.org/crnattachments/2015/SPS/EEC/15_4124_00_s.pdf  
6. 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 us e 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 transferabilit y of the antibiotic resistance and the issue 
of the functionality of the enterotoxin genes present in the genome of the micro-organism. G/SPS/N/EU/147 
 
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  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 co ntaining 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. 
7. 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.   
8. Is there a relevant international st andard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g. title or serial  n u m b e r  o f  C o d e x  
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:   
9. 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 au thorisation 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 fatte ning, 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  
10. Proposed date of adoption (dd/mm/yy) : 17 August 2015 
Proposed date of publication (dd/mm/yy) : 18 August 2015 
11. Proposed date of entry into force: [ ] Six months from date of publication , 
and/or  (dd/mm/yy) : 7 September 2015 
[ ] Trade facilitating measure   G/SPS/N/EU/147 
 
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  12. 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 hand le 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 
13. Text(s) available from: [X] National Notifi cation 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