. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/266 
23 June 2006 
 (06-3078) 
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):  Glucose oxidase enzyme (ICS: 67.060, 67.120, 67.160)  
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 gl ucose oxidase enzyme (English and French; 
pages 1545-1546)  
6. Description of content:   
Health Canada has received a submission to permit the use of the glucose oxidase enzyme 
obtained from a genetically modified Aspergillus oryzae  organism,  Aspergillus oryzae  
Mtl-72 (pHUda107), that carries the gene from Aspergillus niger coding for this enzyme in 
the production of bread, flour, whole wheat fl our, unstandardized bakery products, soft 
drinks, liquid whole egg, egg white (albumen),  and liquid egg yolk destined for drying.  
 Evaluation of available data supports the safet y and effectiveness of this glucose oxidase 
obtained from the genetically modified Aspergillus oryzae  Mtl-72 (pHUda107). 
 
Therefore, it is the intention of Health Canada to recommend that the Food and Drug 
Regulations  be amended to permit the use of this glucose oxidase enzyme obtained from the 
micro-organism specified above in the production of bread, flour, whole wheat flour, unstandardized bakery products, soft drinks, liquid whole egg, egg white (albumen), and 
liquid egg yolk destined for drying 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 perm it the immediate use of the glucose oxidase 
enzyme, as indicated above, while the regulat ory process is undertaken to formally amend 
the Regulations.  A revision to this notifica tion will 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/266 
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, 17 June 2006 (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 Addendum 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 noti fication 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/2006/20060617/pdf/g1-14024.pdf