. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/271 
14 August 2006 
 (06-3892) 
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):  Phospholipase enzyme (ICS:  67. 100) 
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 phospholipase enzyme in the production of Cheddar, Mozzarella and Pizza cheese (Available in English and French, 2 pages).  
6. Description of content:   Health Canada has received a submission to permit the use of a 
phospholipase enzyme derived from a genetically modified Aspergillus oryzae  organism, 
Aspergillus oryzae (PFJo142), that carries the gene from Fusarium venenatum coding for 
this enzyme.  Phospholipase enzymes are classi fied under the broad class of lipase enzymes. 
This phospholipase enzyme will be used in the production of Cheddar, Mozzarella and 
Pizza cheese, at levels consistent with goo d manufacturing practice.  Evaluation of the 
available data supports the safety and effec tiveness of this phospholipase derived from the 
genetically modified Aspergillus oryzae  (PFJo142).  
The use of this phospholipase enzyme derive d from this new source will benefit the 
consumer through the availability of quality food products.  It will also benefit industry 
through more efficient and improved manufacturing conditions.  
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 enzyme derived from the 
micro-organism specified above in the pr oduction of Cheddar, Mozzarella, and Pizza 
cheese, at levels consistent w ith good manufacturing practice.  
As a means to improve the responsiveness of th e regulatory system, an Interim Marketing 
Authorization (IMA) is being issued to permit the immediate use of the phospholipase enzyme, as indicated above, while the regulat ory process is undertaken to formally amend 
the Regulations.  A revision to this notifica tion 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/271 
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, 5 August 2006, Pages 2296-2297 (A vailable 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 notification 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/2006/20060805/pdf/g1-14031.pdf