. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/195 
6 January 2004 
 (04-0025) 
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):  Pullulanase 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 pages of the notified document:   Interim Marketing 
Authorization regarding the use of the pullu lanase enzyme (available in English and 
French;  pages 3995-3996) 
6. Description of content:  Provision currently exists in the Food and Drug Regulations  for 
the use of the enzyme pullulanase at levels consistent with good manufacturing practice in 
the production of starch-derived sweetening agents and a variety of bakery products.  The 
permitted sources of this enzyme are the microorganisms Bacillus acidopullulyticus NCIB 
11647 and Bacillus licheniformis  SE2-Pul-int211 (pUBCDEBRA11DNSI).  
Health Canada has received a submission to  permit the use of the pullulanase enzyme 
obtained from a genetically modified Bacillus subtilis  organism, Bacillus subtilis  RB121 
(pDG268), that carries the gene from Bacillus deramificans  coding for this enzyme. 
Evaluation of available data supports the safe ty and effectiveness of this pullulanase  
obtained from the genetically modified Bacillus subtilis  RB121 (pDG268).  The use of this 
pullulanase enzyme will benefit both the c onsumer and industry through the increased 
availability of quality food products and 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 the pullulanase enzyme obtained from the 
genetically modified Bacillus subtilis  RB121 (pDG268) in the production of distillers' 
mash and brewers' mash and of dextrins, ma ltose, dextrose, glucose (glucose syrup) or 
glucose solids (dried glucose syrup) 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 pe rmit the immediate use of this pullulanase 
enzyme, as indicated above, while the regulat ory process is undertaken to formally amend 
the Regulations.  A revision to this notifi cation 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/195 
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, [   ] Office International des Epizooties, 
[   ] 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, 20 December 2003 (Availab le 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 regul atory text can be  downloaded at:  
http://canadagazette.gc.c a/partI/2003/20031220/pdf/g1-13751.pdf