WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/466 
3 September 2010  
 (10-4566) 
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):  Cheddar cheese, cheese, cottage cheese,  cream cheese, cream cheese spread, 
sour cream and unstandardized milk-based d essert preparations  (ICS Code: 67.100, 
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 the 
chymosin enzyme in the production of cheddar cheese, (naming the variety) cheese, cottage 
cheese, cream cheese, cream cheese with (nam ing the added ingredients), cream cheese 
spread, cream cheese spread with (naming the added ingredients), sour cream and unstandardized milk-based dessert preparations  Language:  English and French  Number 
of pages:  2   
6. Description of content:  Health Canada has received a submission to permit the use of the 
chymosin enzyme derived from a genetically modified Aspergillus niger , Aspergillus niger  
var. awamori  (pCCEx3), that carries the chymosin gene from Camelus dromedarius.  This 
chymosin enzyme will be used in the produc tion of cheddar cheese, (naming the variety) 
cheese, cottage cheese, cream cheese, cream ch eese with (naming the added ingredients), 
cream cheese spread, cream cheese spread with (naming the added ingredients), sour cream 
and unstandardized milk-based dessert preparati ons at a maximum level of use consistent 
with good manufacturing practice.  Evaluation of available data supports the safety and 
effectiveness of chymosin derived from Aspergillus niger  var. awamori  (pCCEx3) in these 
food products. 
Therefore, it is the intention of Health Ca nada to recommend that the Regulations be 
amended to permit the use of chymosin derived from Aspergillus niger  var. awamori  
(pCCEx3) in the production of cheddar cheese, (n aming the variety) cheese, cottage cheese, 
cream cheese, cream cheese with (naming th e added ingredients), cream cheese spread, 
cream cheese spread with (naming the added ingredients), sour cream and unstandardized 
milk-based dessert preparations at a maximum level of use consistent with good manufacturing practice. G/SPS/N/CAN/466 
Page 2  
 
  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 chymosin derived from Aspergillus niger  var. awamori  (pCCEx3) in the production of cheddar cheese, (naming the 
variety) cheese, cottage cheese, cream cheese,  cream cheese with (naming the added 
ingredients), cream cheese spread, cream cheese spread with (naming the added 
ingredients), sour cream and unstandardized milk-based dessert preparations at a maximum 
level of use consistent with good manufactur ing practice while the regulatory process is 
undertaken to amend the Regulations.  
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 chymosin from 
Aspergillus niger  var. awamori  (pCCEx3).  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, 28 August 2010, Pages 2322-2323 (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 August 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 fi nal regulation, normally within 12-18 
months of publication of the Notice of Inte rim Marketing Authorization in the Canada 
Gazette, Part I, 28 August 2010. 
[ ] Trade facilitating measure    G/SPS/N/CAN/466 
 Page 3 
 
 
  12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  11 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:    
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/ p1/2010/2010-08-28/p df/g1-14435.pdf  (Canada Gazette) 
or http://www.gazette.gc.ca/rp-pr/p1/2010/ 2010-08-28/html/notice-avis-eng.html#d110
 
(English) 
http://www.gazette.gc.ca/rp-pr/p1/2010/ 2010-08-28/html/notice-avis-fra.html#d110   
(French)