WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/399 
21 October 2009  
 (09-5179) 
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, unstandardized bakery products, 
unstandardized whole egg, unstandardized egg yolk and modified lecithin  (ICS Codes:  
67.060, 67.120) 
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  
the phospholipase A2 enzyme derived from Aspergillus niger  (PLA-54) in the production 
of bread, flour, whole wheat flour, unstandardi zed 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 a porcine pancreas 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 bakery products, unstanda rdized whole egg, unstandardized egg yolk 
and modified lecithin, at levels consistent with good manufacturing practice.  Evaluation of 
the available data supports the safety and e ffectiveness 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 th is phospholipase A2 enzyme derived from 
Aspergillus niger  (PLA-54) in the production of bread, flour, whole wheat flour, 
unstandardized bakery produc ts, unstandardized whole egg,  unstandardized egg yolk and 
modified lecithin, at levels consiste nt 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 this phospholipase A2 
enzyme, as indicated above, while the regulatory process is undertaken to amend the 
Regulations. G/SPS/N/CAN/399 
Page 2  
 
  The proposed regulatory amendments would be  enabling measures to allow the sale of the 
foods mentioned above that have been manuf actured 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 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, 10 October 2009, Pages 3040-304 1 (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, 10 October 2009. 
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, 10 October 2009. 
[ ] Trade facilitating measure 
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  24 December 2009 
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/399 
 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/ p1/2009/2009-10-10/p df/g1-14341.pdf  (Canada Gazette ) 
or  
http://www.gazette.gc.ca/rp-pr/p1/2009/ 2009-10-10/html/notice-avis-eng.html#d117  
(English) http://www.gazette.gc.ca/rp-pr/p1/2009/ 2009-10-10/html/notice-avis-fra.html#d117
 
(French)