WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/383 
6 March 2009  
 (09-1156) 
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 number(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where applicable):  Bread, flour, whole wheat  flour, unstandardized bakery products, 
unstandardized whole egg, unstandardized e gg yolk and modified lecithin (ICS Codes: 
67.060, 67.120, 67.220) 
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
[ X ] All trading partners, or 
[   ] Specific regions or countries:    
5. Title of the notified document:  Interim Marketing Authorization regarding the use of  the 
phospholipase A2 enzyme in the production of bread, flour, whole wheat flour, unstandardized bakery products, unstandardized  whole egg, unstandardized egg yolk and 
modified lecithin  Language:  English and French  Number of pages:  2   
6. Description of content:  Health Canada has received a submission to permit the use of the 
phospholipase A2 enzyme derived from a genetically modified Aspergillus niger strain, 
Aspergillus niger  (PLA-54) that carries the gene from another strain of Aspergillus niger  
coding for this enzyme. Phospholipase enzymes are classified under the broad class of lipase enzymes.  This phospholipase A2 enzyme will be used in the production of bread, 
flour, whole wheat flour, unstandardized bake ry products, unstandardized whole egg, 
unstandardized egg yolk and modified lec ithin, at levels consistent with good 
manufacturing practice.  Evaluation of th e available data supports the safety and 
effectiveness of this phospholipase A2 derived from the genetically modified Aspergillus 
niger  (PLA-54). 
Therefore, it is the intention of Health Canada to recommend that the Food and Drug 
Regulations be amended to permit the use of this phospholipase A2 enzyme derived from 
Aspergillus niger  (PLA-54) in the production of bread, flour, whole wheat flour, 
unstandardized bakery products, unstandardized  whole egg, unstandardized egg yolk and 
modified lecithin, at levels consis tent with good manufacturing practice. 
As a means to improve the responsiveness of the regulatory system, an Interim Marketing 
Authorization is being issued to permit th e immediate use of this phospholipase A2 
enzyme, as indicated above, while the regul atory process is undertaken to amend the 
Regulations. G/SPS/N/CAN/383 
Page 2  
 
  The proposed regulatory amendments would be enabling measures to allow the sale of the 
foods mentioned above that have been manufactured through the use of the phospholipase A2 enzyme derived from Aspergillus niger  (PLA-54).  The amendments are supported by 
the safety assessment and would have low impact  on the economy and on the environment.  
Consequently, the regulatory amendments ma y 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 N°)     
[ X ] None Does this proposed regulation conform to the relevant international standard?   
 [   ] Yes   [ X ] 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, 28 February 2009, pages 456- 457 (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, 28 February 2009.  
Propose 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, 28 February 2009. 
[   ] Trade facilitating measure  
12. Final date for comments: [   ] Sixty days from the date of circulation of the 
notification and/or ( dd/mm/yy ):  14 May 2009 
Agency or authority designated to handle comments:  [   ] National Notification 
Authority, [ X ] National Enquiry Point.  Address, fax number and E-mail address (if available) of other body:      G/SPS/N/CAN/383 
 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://canadagazette.gc.ca/rp-pr/p1/2009/2009-02-28/pdf/g1-14309.pdf  (Canada Gazette ) 
or  
http://canadagazette.gc.ca/ rp-pr/p1/2009/2009-02-28/html/notice-avis-eng.html#d115  
(English) http://canadagazette.gc.ca/ rp-pr/p1/2009/2009-02-28/html/notice-avis-fra.html#d115
 
(French)