. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/433 
12 March 2010  
 (10-1332) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English/ 
 French 
 
 
 
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):  Bread and unstandardized bakery products  (ICS Codes: 67.060, 67.220) 
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:  Interim Marketing Authorization regarding the use of the 
enzyme amylase in the production of bread  and unstandardized bakery products 
Language:  English and French  Number of pages:  2   
6. Description of content:  Health Canada has received a submission to permit the use of the 
enzyme amylase derived from a genetically modified Bacilluslicheniformis , Bacillus 
licheniformis  MDT06-228, that carries the gene from Pseudomonas stutzeri  IAM1504 
coding for this enzyme. This amylase will be used in the production of bread and unstandardized bakery products at levels c onsistent with good manufacturing practice. 
Evaluation of available data supports the safet y and effectiveness of this amylase derived 
from Bacillus licheniformis  MDT06-228 in these food products. 
Therefore, it is the intention of Health Canada to recommend that the Food and Drug 
Regulations be amended to permit the use of amylase derived from Bacillus licheniformis  
MDT06-228 in the production of bread a nd unstandardized bakery products, such as 
tortillas, at levels consistent with good manufacturing practice. 
As a means to improve the responsiveness of th e regulatory system, an Interim Marketing 
Authorization is being issued to permit the immediate use of amylase derived from the 
genetically modified micro-organism as indicated above, while the regulatory process is undertaken to amend the Regulations.  
The proposed regulatory amendments would be  enabling measures to allow the sale of the 
foods mentioned above that have been ma nufactured through the use of the enzyme 
amylase from Bacillus licheniformis  MDT06-228. The amendments are supported by the 
safety assessment and would have low impact  on the economy and on the environment. 
Consequently, the regulatory amendments ma y proceed directly to final approval and 
publication in the Canada Gazette , Part II. G/SPS/N/CAN/433 
Page 2  
 
  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:    
9. Other relevant documents and language (s) in which these are available:  Canada 
Gazette , Part I, 6 March 2010, Pages 345- 346 (available in English and French) 
10. Proposed date of adoption (dd/mm/yy) :  Immediate for this IMA. For the final regulation, 
normally within 12-18 months of publication of the Notice of Interim Marketing Authorization in the Canada Gazette , Part I, 6 March 2010. 
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) :  Immediate for this IMA. For the final regulation, normally within 12-
18 months of publication of the Notice of Interim Marketing Authorization in the Canada 
Gazette , Part I, 6 March 2010. 
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  20 May 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 address (if available) of other body:    
The electronic version of the regulatory text can be downloaded at:   
http://canadagazette.gc.ca/rp-pr/p1/2010/2010-03-06/pdf/g1-14410.pdf   (Canada Gazette ) 
or  http://canadagazette.gc.ca/ rp-pr/p1/2010/2010-03-06/html/notice-avis-eng.html#d108
  
(English) 
http://canadagazette.gc.ca/ rp-pr/p1/2010/2010-03-06/html/notice-avis-fra.html#d108    
(French)