WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/481 
29 October 2010  
 (10-5701) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Notifying Member:  CANADA
 
If applicable, name of local government involved:    
2. Agency responsible:  Health Canada 
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO;  ICS numbers should be provided in addition, where 
applicable):  Ready-to-eat (RTE) meat and poultry products (ICS Code:  67.120) 
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:  Information Document on Health Canada's Proposal to 
Amend the Food and Drug Regulations  to permit the use of a microbiological preparation 
of Carnobacterium maltaromaticum  strain CB1 in certain ready-to-eat meat and poultry 
products  Language:  English and French  Number of pages:  8   
6. Description of content:  This document provides informati on on Health Canada's proposal 
to amend the Food and Drug Regulations (" Regulations") to permit the use of a 
microbiological preparation of Carnobacterium maltaromaticum  CB1 strain in certain 
ready-to-eat meat and poultry products, name ly: sausage wieners ( hotdogs); sliced roast 
beef; sliced cooked ham; and sliced cooked turkey.  All affected products would be 
packaged under vacuum and would require ma ndatory ingredient labelling for "bacterial 
culture".  The preparation contains both viable as well as non-viable, pasteurized 
lyophilized cells.  It also contains C. maltaromaticum  metabolites of which 
carnobacteriocins exhibit antibacterial activity. 
The purpose for adding C. maltaromaticum  CB1 strain to food is that it can be used as an 
intervention tool against human pathogenic microorganisms such as Listeria 
monocytogenes.  
The C. maltaromaticum  CB1 strain is a gram-positive, non spore-forming lactic acid 
bacteria.  The C. maltaromaticum  CB1 preparation would be applied with a liquid 
applicator or sprayed on the surface of the meat/poultry product.  The bacterium remains 
active throughout the shelf life of the ready-to-eat food product. 
In Canada, microbiological organisms used in  food applications, may be considered food 
additives, depending on their conditions of use.  Permitted food additives that are classified 
as preservatives are listed in the food additiv es tables in Division 16, Table XI of the 
Regulations.  G/SPS/N/CAN/481 
Page 2  
 
  Before a new food additive is a llowed to be used in Canada, a submission must be filed 
with Health Canada so the Department can  conduct a safety evaluation of the proposed 
use(s) of the additive.  Food manufacturers are not permitted to use the additive until the safety assessment has been completed by Health Canada and the Regulations are amended to formally enable its use. 
Through their evaluation of the submission, Health Canada's Food Directorate scientists 
conducted a detailed and rigorous evaluation of both submissions that focussed on safety 
and efficacy.  Their evaluation considered both microbiological and toxicological aspects of 
the proposed use of C. maltaromaticum  CB1 as a food additive.  It was also noted that the 
application of C. maltaromaticum  CB1 affects neither the nutritional nor the organoleptic 
quality of the treated food products.  Based on this assessment, Health Canada scientists 
had no objections from a safety perspective to the proposed use of C. maltaromaticum  CB1.
Health Canada will propose amendments to the Food and Drug Regulations to permit the 
use of C. maltaromaticum  CB1 in these food products at a maximum level of use consistent 
with Good Manufacturing Practice.  The Food and Drug Regulations specify that the 
amount of the food additive added to a food when the maximum level of use is stated to be 
Good Manufacturing Practice shall not exceed  the amount required to accomplish the 
purpose for which that additive is pe rmitted to be added to that food. 
Given that C. maltaromaticum  CB1 has antilisterial properties that may be of benefit to the 
health of Canadians, Health Canada has as signed a high priority to enabling the use of 
C. maltaromaticum  CB1 in certain ready-to-eat meat and poultry products. 
C. maltaromaticum  CB1 is permitted for use in the United States;  therefore, the approval 
of the use of C. maltaromaticum  CB1 in Canada will allow for further harmonization of 
approved antimicrobial intervention methods in  ready-to-eat meat and poultry industry in 
the United States and in Canada. 
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 stan dard?  If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex standard 
or related text)   
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[X] None 
Does this proposed regulation conform to the relevant international standard?   
 [ ] Yes   [ ] No 
 If no, describe, whenever possible, how and why it deviates from the 
international standard:     G/SPS/N/CAN/481 
 Page 3 
 
 
  9. Other relevant documents and language(s) in which these are available:  Health 
Canada's Food and Nutrition Cons ultations Web site, posted  12 October 2010 (available in 
English and French): 
English:  http://www.hc-sc.gc.ca/fn-an/c onsultation/init/index-eng.php  
French:  http://www.hc-sc.gc.ca/fn-an/ consultation/init/index-fra.php  
10. Proposed date of adoption (dd/mm/yy) :  Normally within four to five months from the 
posting of the Information Document  on the Health Canada web site. 
Proposed date of publication (dd/mm/yy) :    
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  The Regulations come into force on the day on which they are adopted in the 
Canada Gazette , Part II. 
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  10 November 2010 
Agency or authority designated to handl e comments:  [ ] National Notification 
Authority, [X] National Enquiry Point.  Address, fax number and e-mail address (if 
available) of other body:    
13. Texts available from:  [ ] National Notification  Authority, [X] National Enquiry Point.  
Address, fax number and e-mail add ress (if available) of other body:   The electronic 
version of "Information Document on Health  Canada's Proposal to Amend the Food and 
Drug Regulations to permit the use of a microbiological preparation of Carnobacterium maltaromaticum strain CB1 in certain ready- to-eat meat and poultry products" can be 
downloaded at:  
"http://www.hc-sc.gc.ca/fn-
an/consultation/init/_carnobacterium_malta romaticum/carnobacterium_maltaromaticum-
eng.php " (English) 
"http://www.hc-sc.gc.ca/fn-
an/consultation/init/_carnobacterium_malta romaticum/carnobacterium_maltaromaticum-
fra.php " (French)