. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/273 
15 September 2006 
 (06-4438) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English/ 
 French 
 
 
  
NOTIFICATION 
 
1. Member to Agreement notifying:  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):  Xylanase enzyme (ICS: 67.060)  
4. Regions or countries likely to be affected, to the extent relevant or practicable:  Not 
stated  
5. Title, language and number of p ages of the notified document:  Interim Marketing 
Authorization regarding the use of the xyla nase enzyme in the production of bread, flour, 
whole wheat flour and unstandardized bakery products  (Available in English and French; 
2 pages)  
6. Description of content:  Health Canada has received a submission to permit the use of the 
xylanase enzyme from a Bacillus subtilis organism, Bacillus subtilis DIDK 0115 (pUB110 
OIS2) genetically modified to contain multiple  copies of the gene coding for the xylanase 
enzyme, in the production of bread, flour, w hole wheat flour and unstandardized bakery 
products at levels cons istent with good manufacturing practi ce.  Evaluation of available data 
supports the safety and effectiveness of this xylanase enzyme derived from Bacillus subtilis 
DIDK 0115 (pUB110 OIS2). 
The use of this xylanase enzyme derived from th is modified micro-organism will benefit the 
consumer through the availability of quality food products.  It will also benefit industry 
through more efficient and improved manufacturing conditions. 
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 enzyme derived from the micro-
organism specified above 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 th e regulatory system, an Interim Marketing 
Authorization (IMA) is being issued to permit the immediate use of the xylanase enzyme, as 
indicated above, while the regulatory process is undertaken to formally amend the 
Regulations.  A revision to this notification w ill be published at the start of the amendment 
process and Members will be given the opportunity at that time to submit comments on this proposed measure.  G/SPS/N/CAN/273 
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. International standard, guideline or recommendation: 
[   ] Codex Alimentarius Commission,  [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention,  [ X ] None 
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:   
9. Relevant documents and language(s) in which these are available:  Canada Gazette, 
Part I, 9 September 2006, Pages 2575-25 76 (available in English and French)  
10. Proposed date of adoption:  Immediate for this IMA.  For the final regulation, will be stated 
in subsequent Revision or A ddendum to this notification.  
11. Proposed date of entry into force:  Immediate for this IMA.  For the final regulation, will 
be stated in subsequent Revision or Addendum to this notification.  
12. Final date for comments:  This document is not for comment at this time.  A comment 
period will be provided in a Re vision of this notification.  
Agency or authority designated to handle comments:  [   ] National notification 
authority, [ X ] National enquiry point, or address, fax number and E-mail address (if 
available) of other body:   
13. Texts available from:  [   ] National notification authority, [ X ] National enquiry point, 
or address, fax number and E-mail address (if available) of other body:   
The electronic version of the regulat ory text can be downloaded at: 
http://canadagazette.gc.ca/partI/2006/20060909/pdf/g1-14036.pdf