. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/309 
7 December 2007  
 (07-5428) 
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 numb er(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 us e of maltogenic amylase in the production of bread, flour, 
whole wheat flour and unstanda rdized bakery products (avail able in English and French, 
2 pages) 
6. Description of content:  Health Canada has received a submission to permit the use of 
maltogenic amylase derived from a genetically modified strain of Bacillus subtilis  RB 147 
(pRB147), that carries the gene from Bacillus stearothermophilus  coding for this enzyme. 
This maltogenic amylase will be used in the pr oduction of bread, flour, whole wheat flour and 
unstandardized bakery products at levels c onsistent with good manufacturing practice. 
Evaluation of available data s upports the safety and effectiven ess of this maltogenic amylase 
derived from Bacillus subtilis  RB 147 (pRB147).  
The use of this maltogenic amylase 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 maltogenic amylase derived from Bacillus 
subtilis RB 147 (pRB147) in the production of the foods listed above 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 perm it the immediate use of maltogenic amylase 
derived from Bacillus subtilis  RB 147 (pRB147) in the production of the foods listed above, 
at levels consistent with good manufacturing practice, whil e the regulatory process is 
undertaken to formally amend the Regulations.  
The proposed regulatory amendments would be  enabling measures to allow the use of 
maltogenic amylase from Bacillus subtilis  RB 147 (pRB-147). The amendments are 
supported by the safety  assessment and would have low impact on the economy and on the 
environment. Consequently, the regulatory am endments may proceed directly to final 
approval and publication in the Canada Gazette , Part II. G/SPS/N/CAN/309 
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, 1 December 2007, Pages 3301-3302  (available in English and French) 
10. Proposed date of adoption:  Immediate for this IMA.  Fo r the final regulation, normally 
within 12-18 months of publication of the Noti ce of Interim Marketing Authorization in the 
Canada Gazette , Part I, 1 December 2007. 
11. Proposed date of entry into force:  Immediate for this IMA.  For the final regulation, 
normally within 12-18 months of publicati on of the Notice of Interim Marketing 
Authorization in the Canada Gazette , Part I, 1 December 2007. 
12. Final date for comments:  14 February 2008 
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 notifica tion authority, [ X ] National enquiry point, 
or address, fax number and E-mail address (if available) of other body: 
The electronic version of the regulator y text can be downloaded at:   
http://canadagazette.gc.c a/partI/2007/20071201/pdf/g1-14148.pdf   (Canada Gazette) 
or  http://canadagazette.gc.ca/part I/2007/20071201/html/no tice-e.html#i7
 (English) 
http://canadagazette.gc.ca/part I/2007/20071201/html/notice-f.html#i7  (French)