. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/255 
20 January 2006 
 (06-0255) 
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):  Lipase enzyme (ICS: 67.220, 67.060, 67.120)  
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 lipas e enzyme in the production of bread, flour, 
unstandardized bakery products and in egg yolk modification and lecithin hydrolysis  
(English and French; page 84).  
6. Description of content:  Health Canada has received a submission to permit the use of the 
lipase enzyme obtained from a genetically modified Aspergillus oryzae  organism,  
Aspergillus oryzae  (MStr115), that carries the gene from Fusarium oxysporum coding for 
this enzyme, in the production of bread, flour, unstandardized bakery products and in egg 
yolk modification and lecithin hydrolysis.  Ev aluation of available data supports the safety 
and effectiveness of this lipase obtained from the genetically modified Aspergillus oryzae  
(MStr115).   
Therefore, it is the intention of Health Canada to recommend that the Food and Drug 
Regulations  be amended to permit the use of this lipase enzyme obtained from the micro-
organism specified above in the production of bread, flour and unstandardized bakery 
products, in whole egg/egg yolk modification and lecithin hydrol ysis 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 lipase 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.  
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   G/SPS/N/CAN/255 
Page 2  
 
  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, 14 January 2006 (availab le 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 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/2006/20060114/pdf/g1-14002.pdf