Notice of Modification to the  List of Permitted Food Enzymes to Enable the Use of the Enzyme Asparaginase, from  
Bacillus subtilis  MOL2940,  in Bread, Flour, Whole Wheat Flour, Unstandardized Foods and Green Coffee   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     1 
  
Notice of Modification to the  List of Permitted Food 
Enzymes to Enable the Use of the Enzyme Asparaginase, 
from Bacillus subtilis  MOL2940, in Bread, Flour, Whole 
Wheat Flour, Unstandardized Foods and Green Coffee  
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0050] 
 
 
 May  21, 2015   
Notice of Modification to the  List of Permitted Food Enzymes to Enable the Use of the Enzyme Asparaginase, from  
Bacillus subtilis  MOL2940,  in Bread, Flour, Whole Wheat Flour, Unstandardized Foods and Green Coffee   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     2 Summary  
 
Food additives are regulated in Canada under Marketing Authorizations  (MAs) issued by the 
Minister of Health and the Food and Drug Regulations.  Approved food additives and their 
permitted conditions of use are set out in the Lists of Permitted Food Additives  that are 
incorporated by reference in the MA’s and publis hed on Health Canada’s website.  A petitioner 
can request that Health Canada approve a new additive or a new condition of use for an already 
approved food additive by filing a food additive submission with the  Department's Food 
Directorate.  Health Canada uses this premarket approval proc ess to determine whether the 
scientific data support the safety of food additives when used under specified conditions in foods 
sold in Canada.  
 
Health Canada received a food additive submission seeking approval for the use of the enzyme 
asparaginase, obtained from Bacillus subtilis  MOL2940, in bread, flour, whole wheat flour, 
unstandardized foods and green coffee.  Asparaginase is used in food app lications to reduce the 
amount of acrylamide  that can be formed during cooking or heat processing from the amino acid 
asparagine that is naturally present in food.  Asparaginase from other microbial sources is 
already permitted for use in the same foods. Information in the submission indicated that 
asparaginase from B. subtilis  MOL2940 is advantageous, compared to asparaginase from other 
permitted sources, a s it functions at a higher optimal temperature thus making the enzyme more 
useful in foods that are baked at higher temperatures.  
 
The results of Health Canada’s evaluation of available scientific data support the safety and 
efficacy of asparaginase from t his source organism when used as described in the requested 
foods.  Therefore, Health Canada has modified the List of Permitted Food Enzymes  to extend the 
permitted sources of asparaginase to a new source organism, B. subtilis  MOL2940 by adding the 
following entry to the list:   
 
Modification to the  List of Permitted Food Enzymes  
 
Item 
No. Additive  Permitted 
Source  Permitted in or 
upon  Maximum Level of Use and 
Other Conditions  
A.3 Asparaginase  Bacillus 
subtilis  
MOL2940  (1) Bread; Flour; 
Whole wheat 
flour  
(2) 
Unstandardized 
foods  
(3) Green Coffee  
 (1) Good Manufacturing 
Practice  
 
 
(2) Good Manufacturing 
Practice  
 
(3) Good Manufacturing 
Practice  
 
  
Notice of Modification to the  List of Permitted Food Enzymes to Enable the Use of the Enzyme Asparaginase, from  
Bacillus subtilis  MOL2940,  in Bread, Flour, Whole Wheat Flour, Unstandardized Foods and Green Coffee   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 Rationale  
 
Health Canada’s Food Directorate has completed a pre -market safety and efficacy assessment of 
asparaginase obtained from B. subtilis  MOL2940.  The assessment considered microbiological, 
toxicological and technical aspects of this food additive when used as described in the table 
above.     
 
The Food Directorate reviewed specifications related to the microbiological safety of the enzyme  
preparation and data demonstrating compliance with these specifications. The Directorate also 
conducted a toxicological evaluation based on a conservative estimated intake of the enzyme 
preparation from its proposed use in the requested foods.  
 
Based on the results of the safety assessment, Health Canada considers that the data demonstrate 
the safety in use of asparaginase obtained from B. subtilis  MOL2940, at a maximum level of use 
consistent with good manufacturing practice (GMP), in bread, flour, whole  wheat flour, 
unstandardized foods and green coffee. The Department has therefore enabled the use of 
asparaginase obtained from this source organism as described in the above table.  
 
Other Relevant Information  
 
Acrylamide is a chemical formed in a reaction between asparagine and reducing sugars when 
food products are heated to temperatures above 120 oC.  Both asparagine and reducing sugars are 
commonly found in many raw food materials.  
 
Health Canada has identified dietary exposure to acrylamide as a potential human health concern 
and therefore is supportive of efforts by industry to find ways to reduce acrylamide in foods. 
Enabling the use of asparaginase obtained from B. subtilis  MOL294 0 will provide an additional 
option for reducing acrylamide formation in food, especially in foods that require higher baking 
temperatures during manufacture (e.g., breakfast cereals).  
 
All enzymes used as food additives, including asparaginase, must meet the specifications for 
enzyme preparations set out in the most recent edition of the Food Chemicals Codex , a 
compendium of standards for the purity and identity of food ingredients, including food 
additives, which is published by United States Pharmacopeia l Convention.  
 
Implementation and Enforcement  
 
The above modification came into force May  21, 2015 , the day it was published in  the List of 
Permitted Food Enzymes . 
 
The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs 
Act and its associated regulations with respect to foods.  
  
Notice of Modification to the  List of Permitted Food Enzymes to Enable the Use of the Enzyme Asparaginase, from  
Bacillus subtilis  MOL2940,  in Bread, Flour, Whole Wheat Flour, Unstandardized Foods and Green Coffee   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4 Contact Information  
 
Health Canada's Food Directorate is committed to reviewing any new scientific information on 
the safety in use of any permitted food additive  including asparaginase  from Bacillus subtilis  
MOL2940 . Anyone wishing to submit new scientific information on the use of this additive or to 
submit any inquiries may do so in writing, by regular mail or electronically.  If you wish to 
contact the Food Directorate elec tronically, please use the word s “asparaginase from Bacillus 
subtilis  MOL2940 " in the subject line of your e -mail.  
 
Bureau of Chemical Safety , Food Directorate  
251 Sir Frederick Banting Driveway  
Tunney’s Pasture, PL: 2202C  
Ottawa, Ontario K1A 0L2  
E-mail:  bcs-bipc@hc -sc.gc.ca