. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/211 
6 August 2004 
 (04-3360) 
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):  Maltogenic amylase enzyme (ICS: 67.220.20) 
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 ma ltogenic amylase obtained from the genetically 
modified Bacillus subtilis  BRG-1 (pBRG-1) in starch used in the production of dextrins, 
maltose, dextrose, glucose (glucose syrup) or gl ucose solids (dried glucose syrup) and in a 
variety of bakery products (available in  English and French;  pages 2103-2104). 
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 enzyme maltogenic amylase from Bacillus 
subtilis  DN1413 (pDN1413) in the production of st arch-derived sweetening agents and a 
variety of bakery products at levels cons istent with good manufacturing practice.  
Furthermore, an Interim Marketing Au thorization (IMA) was published in the Canada 
Gazette , Part I on 21 June 2003 (G/SPS/N/CAN/1771), to permit the immediate use of the 
maltogenic amylase from the genetically modified Bacillus subtilis LFA63.  The use of this 
enzyme was permitted for the same purpo ses as the other maltogenic amylase enzyme 
already listed in the Regulations while the regulatory process was undertaken to amend the 
Regulations. 
 
Health Canada has received a submission to permit the use of the maltogenic amylase enzyme obtained from a genetically modified Bacillus subtilis  micro-organism, Bacillus 
subtilis  BRG-1 (pBRG-1), that carries the gene from Bacillus stearothermophilus coding 
for this enzyme.  Evaluation of available da ta supports the safety and effectiveness of the 
maltogenic amylase from the genetically modified Bacillus subtilis  BRG-1 (pBRG-1). 
 
Therefore, it is the intention of Health Canada to recommend that the Food and Drug 
Regulations  be amended to permit the use of th e maltogenic amylase obtained from the 
genetically modified Bacillus subtilis  BRG-1 (pBRG-1) in starch used in the production of 
dextrins, maltose, dextrose, glucose (glucose syr up) or glucose solids (dried glucose syrup) 
and in a variety of bakery products at levels  consistent with good manufacturing practice. 
                                                      
1 Notification G/SPS/N/CA N/206 replaces notification G/SPS/N/CAN/177.   As such, Members are requested to 
consult G/SPS/N/CAN/206. 
 G/SPS/N/CAN/211 
Page 2  
 
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 maltogenic amylase enzyme, as indicated above, while the regulatory process is undertaken to formally amend the Regulations.  A revision to this notif ication 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. 
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, 31 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 addr ess, 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/2004/20040731/pdf/g1-13831.pdf