Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Amylase Obtained from Pseudomonas fluorescens  DC88 in 
Distillers’ Mash and in Starch used in the Production of Dextrins, Maltose, Dextrose, Glucose (Glucose Syrup) or Glucose Soli ds (Dried 
Glucose Syrup)   
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 Amylase Obtained from 
Pseudomonas fluorescens  DC88 in Distillers’ Mash and 
in Starch used in the Production of Dextrins, Maltose, 
Dextrose, Glucose (Glucose Syrup) or Glucose Solids 
(Dried Glucose Syrup)  
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0063] 
 
 
 January  4, 2016   
Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Amylase Obtained from Pseudomonas fluorescens  DC88 in 
Distillers’ Mash and in Starch used in the Production of Dextrins, Maltose, Dextrose, Glucose (Glucose Syrup) or Glucose Soli ds (Dried 
Glucose Syrup)   
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 MAs and published on Hea lth 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 process 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 alpha -
amylase obtained from Pseudomonas fluorescens  DC88  as a food enzyme at a maximum level of 
use of good manufacturing practice in distillers’ mash and in starch used in the production of 
dextrins, maltose, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup).  
 
Amylase from other sources is already permitted for use in Canada as a food enzyme used in 
distillers’ mash and in starch used in the production of dextrins, maltose, dextrose, glucose 
(glucose syrup) or glucose solids (dried glucose syrup) . 
 
The results of Health Canada’s evaluation of available scientific data support the safety of alpha -
amylase obtained from Pseudomonas fluorescens  DC88  when used as requested by the 
petitioner.  Therefore, Health Canada has modified the List of Permitted Food Enzymes  to extend 
the permitted sources of amylase to include Pseudomonas fluorescens  DC88 by adding it as 
another permitted source organism for item number A.1 of the list as shown below.   
 
Modification to the List of Permitted Food En zymes  
 
Item 
No. Column 1  
Additive  Column 2  
Permitted 
Source  Column 3  
Permitted in or 
upon  Column 4  
Maximum Level of Use and 
Other Conditions  
A.1 Amylase  Pseudomonas  
fluorescens  
DC88  (1) Starch used in the 
production of 
dextrins, dextrose, 
glucose (glucose  
syrup), glucose 
solids (dried glucose 
syrup) or maltose  
 
(2) Distillers' Mash  (1) Good Manufacturing Practice  
 
 
 
 
 
 
 
(2) Good Manufacturing Practice  
 
  
Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Amylase Obtained from Pseudomonas fluorescens  DC88 in 
Distillers’ Mash and in Starch used in the Production of Dextrins, Maltose, Dextrose, Glucose (Glucose Syrup) or Glucose Soli ds (Dried 
Glucose Syrup)   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 Corrective Modifications to the List of Permitted Food Enzymes  
 
Minor corrective modifications are also made to subitems A.1(9), A.1(3), A.1(2), A.1(1), A.1(1), 
A.2(1), G.1(6), G.1(3), G.1(4), P.1(3), P.7(2), P.7(3) and P.7(4) in the List of Permitted Food 
Enzymes  in order to address minor inconsistencies in the food c ategory listings for starch (by 
applying the same alphabetical order and by consistently using the word “or” in the listings).  
 
Rationale  
 
Health Canada’s Food Directorate completed a pre -market safety assessment of the requested 
uses of alpha -amylase obtained from Pseudomonas fluorescens  DC88 .  The assessment 
considered microbiological, toxicological and chemical aspects of this additive, and found that 
the requested uses are acceptable from a food safety perspective. Therefore, the Department has 
enabled the requested uses of alpha -amylase obtained from Pseudomonas fluorescens  DC88  by 
modifying the List of Permitted Food Enzymes  as described in the above table.  
 
Other Relevant Information  
 
The Food and Drug Regulations require that food additives such as amylase, which do not have 
specifications set out in the Regulations, meet the food -grade specifications set out in the most 
recent edition of the Food Chemicals Codex (FCC). The FCC is a compendium of standards for 
purity and identity for food ingredients, including food additives, which is published by the 
United States Pharmacopeial Convention.   
 
Implementation and Enforcement  
 
The above modification came into force January 4, 2016 , 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.  
 
Contact Information  
 
Health Canada's Food Directorate is committed to reviewing any new scientific information on 
the safety in use of any food additive, including amylase obtained from Pseudomonas 
fluorescens  DC88 . 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 electronically, please use the words “ Amylase obtained 
from Pseudomonas fluor escens  DC88 ” in the subject line of your e -mail.  
 
Bureau of Chemical Safety , Food Directorate  
251 Sir Frederick Banting Driveway  
Tunney’s Pasture, PL: 2202C   
Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Amylase Obtained from Pseudomonas fluorescens  DC88 in 
Distillers’ Mash and in Starch used in the Production of Dextrins, Maltose, Dextrose, Glucose (Glucose Syrup) or Glucose Soli ds (Dried 
Glucose Syrup)   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4 Ottawa, Ontario K1A 0L2  
E-mail:  bcs-bipc@hc -sc.gc.ca