. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/252 
14 October 2005 
 (05-4690) 
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: 67.060)  
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 Lipase  Enzyme in Bread, Flour, Unstandardized 
Bakery Products, Egg Yolk/Whole Egg Modification and for the Hydrolysis of Lecithin (Available in English and French;  page 3288).  
6. Description of content:   
Provisions currently exist in Table V to sec tion B.16.100 of the Food and Drug Regulations 
for the use of the enzyme lipase, obtained from various sources of micro-organisms, in 
bread, flour, unstandardized bakery products and edible fats and oils at levels consistent 
with good manufacturing practice. 
Health Canada has received a submission to permit the use of the lipase enzyme obtained 
from a genetically modified strain of Aspergillus oryzae (designated BECh2#3 [pCaHj559]) 
that carries a hybrid gene from Thermomy ces lanuginosus/Fusarium oxysporum coding for 
this enzyme.  This enzyme would be intended for use in bread, flour, unstandardized bakery 
products, egg yolk/whole egg modification and for the hydrolysis of lecithin.  Evaluation of 
available data supports the safety and effec tiveness of the lipase enzyme obtained from the 
genetically modified Aspergillus oryzae BECh2#3 (pCaHj559). 
Therefore, it is the intention of Health Canada to recommend that the Food and Drug 
Regulations be amended to permit the use of  the genetically modified Aspergillus oryzae 
BECh2#3 (pCaHj559) as a production organism for the enzyme lipase used in bread, flour, unstandardized bakery products, modified egg yolk/whole egg, and the manufacture of 
hydrolysed lecithin at levels consis tent 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 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/252 
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, 8 October 2005 (availa ble 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/2005/20051008/pdf/g1-13941.pdf