. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/269 
14 August 2006 
 (06-3890) 
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):  Alpha-amylase enzyme (ICS:  67.180)  
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 alpha-a mylase enzyme in the production of brewers' 
mash, distillers' mash, dextrins, maltose, dext rose, glucose (glucose syrup) and glucose 
solids (dried glucose syrup) (Availabl e in English and French, 2 pages).  
6. Description of content:  Health Canada has received a submission to permit the use of the 
alpha-amylase enzyme derived from a genetically modified Bacillus licheniformis  
organism, the Bacillus licheniformis MOL2083 (pCA164-LE399), that carries a hybrid gene 
from Bacillus amyloliquefaciens  and Bacillus licheniformis  coding for this enzyme.  This 
alpha-amylase will be used in the production of  brewers' mash, distillers' mash, dextrins, 
maltose, dextrose, glucose (glucose syrup) and glucose solids (dried glucose syrup). 
Evaluation of available data supports the safet y and effectiveness of this alpha-amylase 
enzyme derived from the genetically modified Bacillus licheniformis MOL2083 (pCA164-
LE399).  
The use of this alpha-amylase enzyme derived from this modified micro-organism 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 alpha-amylase enzyme derived from the 
genetically modified micro-organism specified  above in the production of brewers' mash, 
distillers' mash, dextrins, maltose, dextrose, glucose (glucose syrup) and glucose solids 
(dried glucose syrup) at levels consis tent with good manufacturing practice.  
As a means to improve the responsiveness of th e regulatory system, an Interim Marketing 
Authorization (IMA) is being issued to pe rmit the immediate use of the alpha-amylase 
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/269 
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 2294-2295 (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