. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/341 
24 June 2008  
 (08-3015) 
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 and glucoamylase in the production of pre-cook ed infant cereals 
(ICS: 67.220, 67.230;  HS Code 1901.10) 
4. Regions or countries likely to be affected, to the extent relevant or practicable :  All 
trading partners.  According to trade statistics, exporters to Canada include the United States, Ireland, Germany, Poland, Denmark,  Netherlands, a nd South Africa. 
5. Title, language and number of pages of the notified document:  Interim Marketing 
Authorization regarding the combined use of alpha-amylase and glucoamylase in the production of pre-cooked infant  cereals (available in En glish and French, 2 pages) 
6. Description of content:  Health Canada has received two submissions to permit the 
combined use of two enzymes, alpha-amylase derived from Bacillus subtilis  and 
glucoamylase derived from Aspergillus niger  in the production of pre- cooked infant cereals at 
levels consistent with good manufacturing practi ce.  Evaluation of available data supports the 
safety and effectiveness of alpha-amylase derived from Bacillus subtilis  and glucolase derived 
from Aspergillus niger  in infant cereals.  
Therefore, it is the intention of Health Canada to recommend that the Food and Drug 
Regulations  be amended to permit the use of alpha-amylase derived from Bacillus subtilis  and 
glucoamylase derived from Aspergillus niger  in the production of infant cereal 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 permit the immedi ate use of alpha-amylase derived 
from Bacillus subtilis  and glucoamylase derived from Aspergillus niger  in the production of 
infant cereals 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 enab ling measures to allow the sale of infant 
cereals that have been manu factured through the use of alpha-amylase derived from Bacillus 
subtilis  and glucoamylase derived from Aspergillus niger . G/SPS/N/CAN/341 
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, 14 June 2008, Pages 1825-1826 (a vailable 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, 14 June 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, 14 June 2008. 
12. Final date for comments:  28 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 regulat ory text can be downloaded at: 
http://canadagazette.gc.c a/partI/2008/20080614/pdf/g1-14224.pdf   (Canada Gazette ) 
or  http://canadagazette.gc.ca/part I/2008/20080614/html/notice-e.html#d102
  (English) 
http://canadagazette.gc.ca/part I/2008/20080614/html/notice-f.html#d102   (French)