WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/403 
15 December 2009  
 (09-6518) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
NOTIFICATION 
 
1. Notifying Member:  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):  Bread; flour and whole wheat flour; unstandardized foods 
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:    
5. Title of the notified document:   
1. Health Canada’s Proposal to Amend the Food and Drug Regulations  to Permit the Use 
of the Enzyme Asparaginase Sourced From Aspergillus oryzae  (pCaHj621/BECh2#10) 
in Certain Food Products – December 2009 
2. Health Canada’s Proposal to Amend the Food and Drug Regulations  to Permit the Use 
of a Second Source ( Aspergillus niger  ASP72) of the Enzyme Asparaginase in Certain 
Food Products – December 2009  Language:  English and French  Number of pages:  
English:  7 both;  French:  7 and 8 
6. Description of content:  In Canada, enzymes used in food applications, such as 
asparaginase, may be consider ed food additives, depending on their conditions of use.  
Permitted food additives are listed in the food additives tables in Division 16 of the Food 
and Drug Regulations .  
Health Canada has received two food additiv e submissions seeking the approval of the 
enzyme asparaginase for use in the manufacture of various standardized and unstandardized 
foods.  The food products covered by the firs t submission are: wheat dough-based products 
such as bread, crackers and cookies; cut potato pr oducts such as French fries; sliced potato 
products; and fabricated potato chips.  The f ood products covered by the second submission 
are:  bread; flour; whole wheat flour and other flours; French fries; potato chips and potato-based products; reaction flavours; and unstanda rdized cereal-based products such as cakes, 
biscuits, cookies and processed breakfast cereals. 
Asparaginase would be used to reduce levels  of free asparagine in food, thereby reducing 
the risk of formation of acrylamide.  Acryla mide is formed as a reaction product between 
asparagine and reducing sugars when certain foods are baked or fried at temperatures exceeding 120oC.  Both asparagine and reduci ng sugars are commonly found in many raw 
food materials.  Dietary exposure to acrylamid e has been identified as of potential concern 
by the Joint FAO/WHO Expert  Committee on Food Additives. G/SPS/N/CAN/403 
Page 2  
 
  Evaluation of the available data supports the safety and effectiveness of asparaginase as a 
food additive for the uses as proposed.  Aspara ginase is permitted for use in Australia, 
China, Denmark, Mexico, the Netherlands, New Zealand, Russia, Singapore, Switzerland and the United States, and has been given a favourable evaluation by the Joint FAO/WHO Expert Committee on Food Additives. 
Therefore, it is the intention of Health Canada to recommend that the Food and Drug 
Regulations  be amended to permit the use of asparaginase as a food additive in bread, flour 
and whole wheat flour, and unstandardized foods , at a maximum level of use consistent 
with Good Manufacturing Practice, that is, the minimum amount needed for the intended technical effect. 
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. Is there a relevant international stan dard?  If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex standard 
or related text)   
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[X] None 
Does this proposed regulation conform to the relevant international standard?   
 [ ] Yes   [ ] No 
 If no, describe, whenever possible, how and why it deviates from the 
international standard:    
9. Other relevant documents and language(s) in which these are available:  Health 
Canada’s Food and Nutrition Consultations Website, posted 9 December 2009 (available in 
English and French) 
10. Proposed date of adoption (dd/mm/yy) :  Within five-eight months from the posting of the 
notified documents on Health Ca nada’s Website, December 2009. 
Proposed date of publication (dd/mm/yy) :    
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  On the date the measure is adopted. 
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  21 February 2010 
Agency or authority designated to handl e comments:  [ ] National Notification 
Authority, [X] National Enquiry Point.  Address, fax number and e-mail address (if 
available) of other body:     G/SPS/N/CAN/403 
 Page 3 
 
 
  13. Texts available from:  [ ] National Notification  Authority, [X] National Enquiry Point.  
Address, fax number and e-mail address (if available) of other body:    
The electronic version of the notified documents can be downloaded at:  
Document 1: 
http://www.hc-sc.gc.ca/fn-an/consultati on/init/_dec2009-asparaginase/asp-oryzae-draft-
ebauche-eng.php  (English) 
http://www.hc-sc.gc.ca/fn-an/consultati on/init/_dec2009-asparaginase/asp-oryzae-draft-
ebauche-fra.php  (French) 
Document 2: 
http://www.hc-sc.gc.ca/fn-an/consultation /init/_dec2009-asparagin ase/asp-niger-draft-
ebauche-eng.php  (English) 
http://www.hc-sc.gc.ca/fn-an/consultation /init/_dec2009-asparagin ase/asp-niger-draft-
ebauche-fra.php  (French)