Notice of Modification to the List of 
Permitted Food Enzymes  to Enable the 
Use of Xylan ase from Trichoderma  
reesei RF5427 in Various Foods  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0206 
August  3, 2023 
 Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Xylan ase from Trichoderma  reesei RF5427 in 
Various Foods | 2 
 Summary  
Food additives are regulated in Canada under Marke ting 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 Permitted Food Additives  that are incorporated by reference in 
the MAs and published on the Canada.ca website. A petitioner can request that Health Canada authorize  a 
new additive , or a new source  or a new condition of use for an already permitted  food additive , by filing a 
food additive submission with the Department's Food Directorate. Health Canada uses this premarket 
authorization  process to determine whether the scientific data support the safety of food additives when 
used under specified conditions in foo ds sold in Canada.  
Health Canada’s Food Directorate received a food additive submission seeking authorization for the use of 
xylanase from Trichoderma  reesei RF5427  in bread, flour, whole wheat flour, unstandardized bakery 
products, grain processing,  brewing and distilling.  The requested maximum level of use for this food enzyme 
is Good Manufacturing Practice.  
Xylanase from other sources is already permitted for use as a food enzyme in bread, flour, whole wheat flour, 
unstandardized bakery products and  brewers’ mash.  However, the  new source organism, T. reesei  RF5427, 
was not a permitted source for any food enzyme in Canada.  
The results of the Food Directorate’s evaluation of available scientific data support the safety of xylanase 
from T. reesei RF5427  when used as requested by the petitioner . Therefore, Health Canada has modified the 
List of Permitted Food Enzymes  to extend  the use of  xylanase from T. reesei RF5427 by adding th e text shown  
in the table  below to  the list  (in bold  font in this Notice to illustrate the change) . For the definition of “Good 
Manufacturing Practice” set out in column 4 as a Maximum Level of Use, see  the Marketing Authorization for 
Food Additives That May Be Used as Food Enzymes . 
 
Modification to the  List of Permitted Food Enzymes  
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 Xylanase  Trichoderma  reesei  
RF5427  (1) 
Bread; Flour; Whole 
wheat flour  (1) 
Good Manufacturing 
Practice  
(2) 
Brewers’ mash (2) 
Good Manufacturing 
Practice  
(3) 
Distillers ’ mash (3) 
Good Manufacturing 
Practice  
(4) 
Unstandardized bakery 
products  (4) 
Good Manufacturing 
Practice  Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Xylan ase from Trichoderma  reesei RF5427 in 
Various Foods | 3 
 Rationale  
Health Canada’s Food Directorat e completed a premarket safety a ssessment of xylanase from T. reesei 
RF5427 for use as a food enzyme in bread, flour, whole wheat flour , brewers’  mash,  distillers’ mash,  and 
unstandardized bakery products . The Directorate considered allergenicity, chemistry, microbiology, 
molecular b iology, nutrition, and toxicology in the assessment. The resu lts of the assessment support  the 
safety of xylanase from T. reesei RF5427  for its requested use  in these foods . Therefore, Health Canada  has 
enabled the requested food additive uses of xylanase from T. reesei RF5427  by adding to the List of Permitted 
Food Enzymes  the new entries shown  in the above table.  
Other Relevant Information  
Food ad ditives such as xylanase  are required to meet food -grade specifications set out in Part B of the 
Regulations , where such specifications exist,  or those 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 food -grade specifications  for food ingredients, including food additives, published by the 
United States Pharmacopeial Convention. Specifications in the  Combined Compendium of Food Additi ve 
Specifications  and its associated General Specifications and Considerations for Enzyme Preparations  are 
prepared by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) , both of which are  published 
by the Food and Agriculture Orga nization of the  United Nations.  
In Canada, enzymes used as food additives are referred to as food enzymes. The use of xylanase from T. 
reesei RF5427  in grain processing, as described by the petitioner, is consistent with that of a food processing 
aid rather than a food a dditive1. Health Canada has issued the petitioner a letter of opinion expressing no 
objection to th e use of xylanase  from T. reesei RF5427  in grain processing  under specified conditions.  
Implementation and Enforcement  
The above modification came into force August  3, 2023, 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.  
 
1 Health Canada’s general approach for classifying substances as food additives or food processing aids is described 
in the Policy for Differentiating Food Additives and Processing Aids  (https://www.canada.ca/en/health -
canada/services/food -nutrition/reports -publications/policy -differentiating -food-additives -processing -aids-2008.html ) Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Xylan ase from Trichoderma  reesei RF5427 in 
Various Foods | 4 
  
 
Contact Information  
Health Canada's Food Directorate is committed to rev iewing new scientific information on the safety in use of 
any permitted  food additive . Anyone wishing to submit an inquiry or new scienti fic information on the use of 
a permitted food additive may do so in writing, by r egular mail or electronically. If you  wish to contact the 
Food Directorate electronically  about xylanase , please use the words “xylanase  (NOM -0206)" 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: bcs-bipc@hc -sc.gc.ca