. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/333 
6 June 2008  
 (08-2661) 
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):  Alpha-amylase used in starch used in  the production of certain food products 
(ICS:  67.220) 
4. Regions or countries likely to be affected, to the extent relevant or practicable :  All 
trading partners 
5. Title, language and number of pages of the notified document:  Interim Marketing 
Authorization regarding the use of alpha-amylase used in starch used in the production of 
dextrins, maltose, dextrose , glucose (glucose syrup) or glucose solids (dried glucose syrup), 
and in distillers' mash, brewer s' mash, bread, flour, whole wh eat flour, and unstandardized 
bakery products (available in English and French, 2 pages) 
6. Description of content:  Health Canada has received a subm ission to permit the use of the 
alpha-amylase derived from a genetically modified Bacillus licheniformis , Bacillus 
licheniformis  strain 3253 (plCatH-3253), that carries the gene from Bacillus 
stearothermophilus  coding for this enzyme.  This alpha-am ylase will be used in  starch used in 
the production of dextrins, maltose, dextrose, gluc ose (glucose syrup) or glucose solids (dried 
glucose syrup), and in distillers' mash, brew ers' mash, bread, flour, whole wheat flour, and 
unstandardized bakery products at levels c onsistent with good manufacturing practice.  
Evaluation of available data supports the safe ty and effectiveness of the alpha-amylase 
derived from Bacillus licheniformis  strain 3253 (plCatH-3253) in these food products.  
Therefore, it is the intention of Health Canada to recommend that the Food and Drug 
Regulations  be amended to permit the use of the alpha-amylase derived from Bacillus 
licheniformis strain 3253 (plCatH-3253) 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 the alpha-amylase 
derived from Bacillus licheniformis  strain 3253 (plCatH-3253) in the production of the foods 
listed above, at levels cons istent with good manufacturing pr actice, while the regulatory 
process is undertaken to form ally amend the Regulations. 
The proposed regulatory amendments would be en abling measures to allow the sale of the 
foods mentioned above that have been manuf actured through the use of the alpha-amylase 
derived from Bacillus licheniformis  strain 3253 (plCatH-3253). G/SPS/N/CAN/333 
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, 31 May 2008, Pages 1668-1669 (ava ilable 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, 31 May 2008. 
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, 31 May 2008. 
12. Final date for comments:  14 August 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/2008/20080531/pdf/g1-14222.pdf   (Canada Gazette ) 
or  http://canadagazette.gc.ca/part I/2008/20080531/html/notice-e.html#d118 
 (English) 
http://canadagazette.gc.ca/part I/2008/20080531/html/notice-f.html#d118   (French)