WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/471 
23 September 2010  
 (10-4858) 
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 numbe r(s) as specified in national schedules 
deposited with the WTO;  ICS numbers should be provided in addition, where 
applicable):  Bread, flour, whole wheat flour and unstandardized bakery products  (ICS 
Code:  67.060, 67.220) 
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:    
5. Title of the notified document:  Interim Marketing Authorization regarding the use of 
lipase enzyme in the production of bread, fl our, 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 
lipase enzyme derived from a genetically modified Aspergillus niger  strain, Aspergillus 
niger  (LFS-54), that carries the gene from Fusariumculmorum coding for this enzyme.  
This lipase enzyme will be used in the produc tion of bread, flour, whole wheat flour and 
unstandardized bakery products at maximu m levels of use consistent with good 
manufacturing practice. Evaluation of availabl e data supports the safety and effectiveness 
of this lipase derived from Aspergillus niger  (LFS-54) in the production of bread, flour, 
whole wheat flour and unstandardized bakery pr oducts at maximum levels of use consistent 
with good manufacturing practice. 
Therefore, it is the intention of Health Ca nada to recommend that the Regulations be 
amended to permit the use of lipase derived from Aspergillus niger  (LFS-54) in the 
production of bread, flour, whole wheat flour  and unstandardized bakery products at 
maximum levels of use consistent  with good manufacturing practice. 
As a means to improve the responsiveness of th e regulatory system, an Interim Marketing 
Authorization is being issued to permit the immediate use of lipase derived from 
Aspergillus niger  (LFS-54) in the production of bread, flour, whole wheat flour and 
unstandardized bakery products at maximu m levels of use consistent with good 
manufacturing practice while the regulator y process is undertaken to amend the 
Regulations.  G/SPS/N/CAN/471 
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 the lipase from 
Aspergillus niger  (LFS-54).  The amendments are supported by the safety assessment and 
would have low impact on the economy a nd on 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 number)    
[X] None Does this proposed regulation conform to the relevant international standard?   
 [ ] Yes   [ ] 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, 11 September 2010, Pages 2443-2 444 (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, 11 September 2010. 
Proposed 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, 11 September 2010. 
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  25 November 2010 
Agency or authority designated to handl e comments:  [ ] National Notification 
Authority, [X] National Enquiry Point.  Address, fax number and e-mail address (if 
available) of other body:    G/SPS/N/CAN/471 
 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://www.gazette.gc.ca/rp-pr/ p1/2010/2010-09-11/p df/g1-14437.pdf  (Canada Gazette ) 
or  
http://www.gazette.gc.ca/rp-pr/p1/2010/ 2010-09-11/html/notice-avis-eng.html#d108  
(English) http://www.gazette.gc.ca/rp-pr/p1/2010/ 2010-09-11/html/notice-avis-fra.html#d108
 
(French)