WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/379 
23 February 2009  
 (09-0938) 
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 number(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where 
applicable):  Bread, flour, whole wheat flour a nd 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, or 
[   ] Specific regions or countries:    
5. Title of the notified document:  Interim Marketing Authorization regarding the use of the 
xylanase enzyme in the production of bread, flour, whole wheat flour 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 
xylanase enzyme derived from a genetically modified Bacillus subtilis , the Bacillus subtilis  
strain CF 307 (pJHPaprExynAss-BS3xylanase#1), that carries the gene from another strain 
of Bacillus subtilis  coding for this enzyme.  This xyla nase will be used in the production of 
bread, flour, whole wheat flour and unstandard ized bakery products such as bread and 
cakes at levels consistent with good manufactur ing practice.  Evaluation of available data 
supports the safety and effectiveness of this xylanase derived from Bacillus subtilis  CF 307 
(pJHPaprE-xynAss-BS3xylanase#1) 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 this xylanase derived from Bacillus subtilis  
CF 307 (pJHPaprE-xynAss-BS3xylanase#1) in the production of bread, flour, whole wheat 
flour and unstandardized bakery products at levels consistent with good manufacturing 
practice. 
As a means to improve the responsiveness of the regulatory system, an Interim Marketing 
Authorization is being issued to permit th e immediate use of this xylanase enzyme, as 
indicated above, while the regulatory pro cess is undertaken to amend the Regulations. G/SPS/N/CAN/379 
Page 2  
 
   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 xylanase from 
Bacillus subtilis  CF 307 (pJHPaprE-xynAss-BS3xyla nase#1).  The amendments are 
supported by the safety assessment and would have a low impact on the economy and the 
environment.  Consequently, the regulatory amendments may proceed directly to final 
approval and publication in the Canada Gazette , Part II.  
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 N°)     
[ X ] None Does this proposed regulation conform to the relevant international standard?   
 [   ] Yes   [ X ] 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, 14 February 2009, Pages 326- 327 (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, 14 February 2009.  
Propose 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, 14 February 2009. 
[   ] Trade facilitating measure  
12. Final date for comments: [   ] Sixty days from the date of circulation of the 
notification and/or ( dd/mm/yy ):  30 April 2009 
Agency or authority designated to handle comments:  [   ] National Notification 
Authority, [ X ] National Enquiry Point.  Address, fax number and E-mail address (if available) of other body:      G/SPS/N/CAN/379 
 Page 3 
 
 
  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/partI/2008/20090214/pdf/g1-14307.pdf  (Canada Gazette ) 
or  
http://canadagazette.gc.ca/partI/2008/20090214/html/notice-e.html#d102  (English) 
http://canadagazette.gc.ca/partI/2008/20090214/html/notice-f.html#d102  (French)