. /.  WORLD TRADE  
ORGANIZATION   
G/SPS/N/CAN/533 
7 June 2011  
 (11-2798) 
Committee on Sanitary and 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):  Hydrolyzed animal, milk and vegetabl e proteins (ICS Codes:  67.080, 67.100, 
67.120, 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 
protease derived from Aspergillus melleus  in the production of hydrolyzed animal, milk and 
vegetable proteins  Language(s):  English and French  Number of pages:  2 
6. Description of content:  Health Canada has received a submission to permit the use of 
protease derived from Aspergillus melleus , which functions to break down proteins into 
smaller constituents such as peptides and amino acids, in the production of hydrolyzed milk 
proteins at a level of use consistent with  good manufacturing practice.  Evaluation of 
available data supports the safety and effectiveness of protease derived from Aspergillus 
melleus  in the production of hydrolyzed animal, milk and vegetable proteins. 
Therefore, it is the intention of Health Ca nada to recommend that the Regulations be 
amended to permit the use of protease derived from Aspergillus melleus  in the production 
of hydrolyzed animal, milk and vegetable prot eins at a level 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 protease derived from 
Aspergillus melleus , as indicated above, 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 manuf actured through the use of protease derived 
from Aspergillus melleus .  The amendments are supported by the safety assessment and 
would have a 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. G/SPS/N/CAN/533 
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. 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 May 2011, Pages 1718-1719 (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 May 2011. 
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 Interim Marketing Authorization in the Canada 
Gazette , Part I, 28 May 2011. 
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  11 August 2011 
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/p1/201 1/2011-05-28/pdf/g1- 14522.pdf#page=40   (Canada 
Gazette ) 
or  http://www.gazette.gc.ca/rp-pr/p1/2011/ 2011-05-28/html/notice-avis-eng.html#d101  
(English) 
http://www.gazette.gc.ca/rp-pr/p1/2011/ 2011-05-28/html/notice-avis-fra.html#d101  
(French)