. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/313 
5 March 2008  
 (08-0987) 
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):  Amylase derived from Aspergillus oryzae var.  in the production of 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 :  This 
measure applies to the above-noted product from all sources.  Based on trade statistics, major 
suppliers are:  the United States, Ir eland, Germany, Po land and Denmark. 
5. Title, language and number of pages of the notified document:  Interim Marketing 
Authorization regarding the use of amylase derived from Aspergillus oryzae var.  in the 
production of infant cereals  (available in English and French, 2 pages) 
6. Description of content:  Health Canada has received a submission to permit the use of 
amylase derived from Aspergillus oryzae var.  in the production of infant cereals at levels 
consistent with good manufacturing practice.  Evaluation of availa ble data supports the safety 
and effectiveness of amylase derived from Aspergillus oryzae var.  in these food products.  
The use of amylase derived from this micro-or ganism will benefit the consumer through the 
availability of quality food products.  It will al so 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 amylase derived from Aspergillus oryzae var.  in 
the production of infant cere als at levels consistent wi th 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 immediate use of amylase derived from 
Aspergillus oryzae var. in the production of the foods listed above, at levels consistent with 
good manufacturing practice, while the regulatory process is unde rtaken to formally amend 
the Regulations. 
The proposed regulatory amendments would be  enabling measures to allow the use of 
amylase derived from Aspergillus oryzae var.   The amendments are supported by the safety 
assessment and would have low impact on the economy and the environment.  Consequently, 
the regulatory amendments may proceed directly to final a pproval and publication in the 
Canada Gazette , Part II. G/SPS/N/CAN/313 
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 March 2008, Pages 489-490 (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, 1 March 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, 1 March 2008. 
12. Final date for comments:  15 May 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/2008/20080301/pdf/g1-14209.pdf   (Canada Gazette ) 
or  http://canadagazette.gc.ca/part I/2008/20080301/html/notice-e.html#d108
  (English) 
http://canadagazette.gc.ca/part I/2008/20080301/html/notice-f.html#d108  (French)