Notice of Modification to the List of 
Permitted Food Enzymes  to Enable  the 
Use of Cellulase from Trichoderma 
reesei  RF11412 in Brewers’ mash and 
Distillers’ mash  
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0209 
October 11 , 2023 
 Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Cellulase from Trichoderma reesei  RF11412 in 
Brewers’ mash and Distillers’ mash| 2 
 Summary  
Food additives are regulated in Canada under Marketing Authorizations  (MAs) issued by th e 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 
approve a new additive , or a new source  or a new condition of use for an already approved food 
additive , by filing a food add itive 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 foods sold in Canada.  
Health Canada’s Food Directorate received a food additive submission s eeking authorization  for the use 
of endo -1,4-β-D-glucanase , also named  cellulase,  from Trichoderma reesei RF11412 in brewers’ mash, 
distillers’ mash and grain processing. The requested maxi mum level of use is Good Manufacturing 
Practice . 
Cellulase from Aspergillus  niger  var. is already permitted for use as a food enzyme in distillers’ mash, 
and cellulase from Rasamsonia  emersonii  is already permitted in brewers’ mash. However, the new 
source organism, T. reesei  RF11412, was not a permitted source for any food enzyme in C anada.  
The results of the Food Directorate’s evaluation of available sci entific data support the safety  of 
cellulase from T. reesei RF11412 as a food enzyme when used as set out in the table  below . Therefore, 
Health Canada has modified the List of Permitted Food Enzymes  to enable  the use of cellulase from T. 
reesei RF11412 by adding the new source organism “Trichoderma reesei RF11412 ” to Column 2 , and 
corresponding foods and Maximum Levels of Use to Columns 3 and 4 , of Item C.2 in the list, as shown in 
the table below . 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  
C.2 Cellulase  Trichoderma  reesei  
RF11412  (1) 
Brewers’ mash  (1) 
Good Manufacturing 
Practice  
(2) 
Distillers’ mash  (2) 
Good Manufacturing 
Practice  
Rationale  
Health Canada’s Food Directorate completed a premarket safety assessment  of cellulase from T. reesei 
RF11412  for use as a food enzyme  in brewers’ mash and distillers’ mash . The Directorate considered  
allergenicity, chemistry, microbiology, molecular biology, nutrition, and toxicology in the assessment. 
The results of the assessment support the safety of cellulase from T. reesei  RF11412 for its requested Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Cellulase from Trichoderma reesei  RF11412 in 
Brewers’ mash and Distillers’ mash| 3 
 uses.  Therefore, the Department has enabled the requested uses of  cellulase from T. reesei RF11412  by 
adding to the  List of Permitted Food Enzymes  the new entr y shown in the above table.  
Other Relevant I nformation  
Food additives such as cellulase from T. reesei  RF11412 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 
where there are no specifications in Part B . 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 Additive Specifications  
and its associated General Specifications and Considerations for Enzyme Preparations  are prepared by 
the Joint FAO/WHO Expert Committee on Foo d 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 cellulase  from T. 
reesei  RF11412 in grain processing, as described by the petitioner, is consistent with that of a food 
processing aid rather than a food additive1. Health Canada has issued the petitioner a letter of opinion 
expressing no objection to the use of cellulas e from T. reesei  RF11412  in grain processing under 
specified conditions.  
Implementation and Enforcement  
The above modification came into force October 11 , 2023, the day it was published in List of Permitted 
Food Enzymes . 
The Canadian Fo od 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 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 additive may do so in writing, by regular mail or electronically.  If you wish to 
contact the Food Directorate electro nically  about cellulase  from Trichoderma  reesei  RF11412,  please use 
the words “cellu lase (NOM -0209)" 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  
 
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 )