 
  
Notice of Modification to the List of 
Permitted Food Enzymes  to Enable the 
Use of Xylanase  from  Aspergillus acidus 
RF7398  in Specified Flour and Flour 
Bakery Products  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0159 
February  1, 2021 
 Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Xylanase from Aspergillus acidus  RF7398 in 
Specified Flour and Flour Bakery Products  – Reference Number: NOM/ADM -0159| 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 
xylanase from Aspergillus acidus  RF7398 as a food enzyme  in bread, flour, pasta, unstandardized bakery 
products, and whole wheat f lour. The food enzyme is intended to be used at a level consistent with Good 
Manufacturing Practice . 
Xylanase  from other sources other than A. acidus  RF7398 is already permitted for use in Canada as a food 
enzyme  in the manufacture of all the foods of interest to the petitioner , other than  pasta.  
The results of the Food Directorate’s evaluation of available scientific data support the safety of xylanase 
from A. acidus  RF7398  when used as set out in the table below.  Therefore, Health Canada has modified the 
List of Permitted Food Enzymes  to extend the use of xylanase from A. acidus  RF7398  by adding the entries 
shown below to t he list .  
 
Modification to the  List of Permitted Food Enzyme s 
Item 
No. Column 1  
Additive  Column 2  
Permitted Source  Column 3  
Permitted in or Upon  Column 4  
Maximum Level of Use 
and Other Conditions  
X.1 Xylana se Aspergillus acidus  RF7398  (1) 
Bread; Flour; Whole 
wheat flour  (1) 
Good Manufacturing 
Practice  
(2) 
Pasta  (2) 
Good Manufacturing 
Practice  
(3) 
Unstandardized bakery 
products  (3) 
Good Manufacturing 
Practice  
Rationale  
Health Canada’s Food Directorate completed a premarket safety assessment of xylanase from A. acidus  
RF7398  for use as a food enzyme .  The assessment conclud ed that information related to allergenicity, 
chemistry, microbiology, molecular biology, nutrition, and toxicology supports the safety of  xylanase from A. 
acidus  RF7398  for its requested uses.  Therefore, the Department has enabled the requested uses of xylanase 
from A. acidus  RF7398  by adding to the List of Permitted Food Enzymes  the new entr ies shown in the above 
table.  Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Xylanase from Aspergillus acidus  RF7398 in 
Specified Flour and Flour Bakery Products  – Reference Number: NOM/ADM -0159| 3 
 Other Relevant Information  
The Food and Drug Regulations  require that food additives such as xylanase that do not have food -grade 
specifications set out in Part B of the Regulations meet the food -grade specifications set out in the  most 
recent  edition of the  Food Chemicals Codex  or the Combined Compendium of Food Additive Specifications .  
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 and Enforcement  
The above modification cam e into force February  1, 2021, the day it was published in  the List of Permitted 
Food Enzymes .  
The Canadian Food Inspect ion 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 new scientific information on the safety in use of 
any permitted food additive, including xylanase from A. acidus  RF7398 .  Anyone wishing to submit new 
scientific information on the use of this add itive 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 
"Xylanase  (NOM -0159)" in the subject line of your e -mail.  
 
Bureau of Chemical Safety, Food Directorate  
251 Sir Frederick Banting Driveway  
Tunney’s Pasture, PL: 2202 C 
Ottawa, Ontario K1A 0K9  
E-mail: hc.bcs -bipc.sc@canada.ca  