 
  
Notice of Modification to the List of 
Permitted Food Enzymes to Enable the 
Use of Phospholipase from Aspergillus 
oryzae AT969  in Bread, Flour , Whole 
Wheat Flour  and Unstandardized 
Bakery Products . 
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0146 
April 15 , 2020 
 Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Phospholipase from Aspergillus oryzae  AT969  in 
Bread, Flour, Whole Wheat Flour and Unstandardized Bakery Products  – Reference Number: [NO M/ADM -0146 ]| 2 
 Summary  
Food additives are regulated in Canada under Marketing Authorizations  (MAs) issued by the Minister of 
Health and the Food and Drug Regulations  (Regulations) .  Approved food additives and their permitted 
conditions of use are set out in the Lists of Pe rmitted Food Additives  that are incorporated by reference in 
the MAs and published on the Canada.ca 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 foo d 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’s Food Directorate received a food additive submission seeking approval for the use of 
phospholipase A1  from  Aspergillus oryzae AT969, as  a food enzyme in bread , flour , whole wheat flour  and 
unstandardized bakery products .  The food enzyme is i ntended to be used at a level consistent w ith Good 
Manufacturing Practice .    
Phospholipase  from other sources is  already permitted for use in Canada as a food enzyme  in bread , flour , 
whole wheat flour  and unstandardized bakery products .  A. oryzae  AT969, which expresses phospholipase A1 
from Valsaria rubicosa , is not a permitted source organism for any food enzyme in Canada.  
The results of the Food Directorate’s evaluation of available scientific data support the safety of 
phospholipase from A. oryzae  AT969 , when used as set out in the table below .  Therefore, Health Canada has 
modified the List of Permitted Food Enzy mes to extend the use of phospholipase  from A. oryzae  AT969  by 
adding the entry shown below to the list . 
 
Modification to the List of Permitted Food Enzym es 
 
Item 
No. Column 1  
Additive  Column 2  
Permitted Source  Column 3  
Permitted in or Upon  Column 4  
Maximum Level of Use 
and Other Conditions  
P.5.2 Phospholipase  Aspergillus oryzae  
AT969  (1) 
Bread; Flour; Whole 
wheat flour  (1) 
Good Manufacturing 
Practice  
(2) 
Unstandardized bakery 
products  (2) 
Good Manufacturing 
Practice  
 
Rationale  
Health Canada’s Food Directorate completed a premarket safety assessment of phospholipase from A. oryzae  
AT969  for use as a food enzyme .  The assessment concluded that information re lated to chemistry, 
microbiology, molecular b iology, nutrition, toxicology, and allergenicity  supports the safety of phospholipase 
from A. oryzae  AT969  for its requested uses.  Therefore, the Department has enab led the requested uses of 
phospholipase from A. oryzae  AT969  by adding to the List of Permitted Food Enzymes  the new entr y shown in 
the above table.  Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Phospholipase from Aspergillus oryzae  AT969  in 
Bread, Flour, Whole Wheat Flour and Unstandardized Bakery Products  – Reference Number: [NO M/ADM -0146 ]| 3 
  
Other Relevant Information  
The Food and Drug Regulations  require that food additives such as phospholipase  that do not have food -
grade specifications set out in Part B of the Regulations meet the most recent food -grade specifications set 
out in the Food Chemicals Codex  or the Combined Compendium of Food Additive S pecifications .  The Food 
Chemicals Codex  is a compendium of standards for purity and identity for food ingredients, including food 
additives, published by the United States Pharmacopeial Convention. The Combined Compendium of Food 
Additive Specifications  and its associated General Specifications and Considerations for Enzyme Preparations  
are prepared by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and published by the Food 
and Agriculture Organization of the United Nations.  
Implementation an d Enforcement  
The above modification came into force  April 15, 2020 , 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  
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 phospholipase from  A. oryzae  AT969 .  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 
"phospholipase (NOM -0146)" 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 0K9  
 
E-mail: hc.bcs -bipc.sc@canada.ca  