. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/208 
26 July 2004 
 (04-3224) 
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 numbe r(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where 
applicable):  Amylase and protease enzymes (I CS:  67.220.20, 67.160) 
4. Regions or countries likely to be affected, to the extent relevant or practicable:  not 
stated  
5. Title, language and number of pages of the notified document:   Interim Marketing 
Authorization regarding the use of the am ylase and protease enzymes in the production of 
beverages made from rice, multi-grain and soya  (available in English and French;  pages 
1952-1953). 
6. Description of content:  Provision currently exists in Table V to section B.16.100 of the 
Food and Drug Regulations  for the use of the enzymes amylase and protease in the 
production of various foods at levels consis tent with good manufacturing practice.  The 
permitted sources of the amylase enzyme include barley malt and the microorganisms 
Bacillus subtilis  and Aspergillus oryzae .  The permitted sources of the protease enzyme 
include the microorganism Bacillus subtilis . 
Health Canada has received a submission to permit the use of the amylase and protease 
enzymes obtained from the permitted sources lis ted above in the production of beverages 
made from rice, multi-grain and soya, and oat and soya at levels consistent with good 
manufacturing practice.  Evaluation of availabl e data supports the safety and effectiveness 
of this new use of the amylase and protease enzymes. 
Therefore, it is the intention of Health Canada to recommend that the Food and Drug 
Regulations  be amended to permit the use of the amylase and protease enzymes obtained 
from the sources specified above in the production of beverages made from rice, multi-
grain and soya, and oat and soya at levels consistent with good manufacturing practice. 
As a means to improve the responsiveness of the regulatory system, an Interim Marketing 
Authorization (IMA) is being issued to permit the immediate use of the amylase and 
protease enzymes, as indicated above, while the regulatory process is undertaken to 
formally amend the Regulations.  A revision to  this notification 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/208 
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, 17 July 2004 (available 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 notificati on 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/2004/20040717/pdf/g1-13829.pdf