 
  
Notice of Modification to the List of 
Permitted Food Enzymes  to Enable  the 
Use of Pectin Lyase from  Trichoderma  
reesei RF6199  in Various Foods  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0190 
Sept ember  23, 2022 
 Notice of Modification to the List of Permitted Food Enzymes  to Enable  the Use of Pectin Lyase from T. reesei RF6199  in Various Foods  
| 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 Per mitted 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 , a new source  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’s Food Directorate received a food additive submission seeking approval for the use of pectin 
lyase from Trichoderma reesei  RF6199  as a food enzyme in  fruit and vegetable processing , and wine 
production1. This food enzyme is intended  to be used at a level consistent with Good Manufacturing 
Practice2. 
Several of the specific types of foods that the petitioner requested are included in broader food categorie s. 
Consequently, the use of pectin lyase from T. reesei  RF6199  is permitted in t hese specific foods even though 
they are not specifically identified as such in the List of Permitted Food Enzymes : 
(1) The enzyme is intended to be added in the processing of single -strength fruit juices, that would 
subsequently be used to manufacture concentrated (naming the fruit) juice3. Consequently, the 
permitted use is captured in “single -strength fruit juices ”, instead  of the final product “concentrated 
(naming the fruit) juice”, as shown in the table below ; 
(2) The food category “Unstandardized fruit and vegetable products” includes “fruit and vegetable 
purées ”; 
(3) The enzyme is intended to be added in  the processing of distillers ’ mash4 that would subsequently be 
used to manufacture fruit brandy . Consequently,  the permitted use is captured in “distillers’ mash ”, 
instead of the final product  “fruit brandies ”, as shown in the table below.  
Pectin lyase fr om another source , Aspergillus niger  Rung373,  is already permitted for use in Canada as a food 
enzyme in the same foods  of interest to the petitioner . However, T. reesei  RF6199  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 pectin lyase 
from T. reesei  RF6199  for the uses set out in the table below.  Therefore, Health Canada has modified the List 
of Permitted Food Enzymes  to extend the use of pectin lyase  to include this new source organism for this 
enzyme by adding the entry shown below  to the l ist. 
 
                                                             
1 Fruit and vegetable processing, and wine production include manufacture of concentrated (naming the fruit) 
juice , fruit and vegetable purées , fruit brandies , single -strength fruit juices , unstandardized fruit and vegetable 
products , and wine . 
2 “Good Manufacturing Practice”  means that the amount of the food enzyme t hat is added to  the food in 
manufacturing and processing does  not exceed the amount required to accomplish the purpose for which it has 
been added , as defined in  the Marketing Authorization for Food Additives That May Be Used as Food Enzymes . 
3 There is a standard of composition for C oncentrated (naming the fruit) juice as per section B.11.130  of the 
Regulations.  
4 By “distillers’ mash”, the petitioner referr ed to a fruit mash that is fermented and distilled to produc e fruit 
brandy.  Notice of Modification to the List of Permitted Food Enzymes  to Enable  the Use of Pectin Lyase from T. reesei RF6199  in Various Foods  
| 3 
 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  
P.3 (i) Pectin 
lyase  Trichoderma reesei  
RF6199  (1) 
Distillers’ Mash   (1) 
Good Manufacturing 
Practice  
(2) 
Single -strength fruit 
juices  (2) 
Good Manufacturing 
Practice  
(3) 
Unstandardized fruit and 
vegetable products  (3) 
Good Manufacturing 
Practice  
(4)  
Wine  (4) 
Good Manufacturing 
Practice  
Rationale  
Health Canada’s Food Directorate completed a premarket safety assessment of pectin lyase from T. reesei  
RF6199  for use as a food enzyme .  The Department  conclud ed that information related to allergenicity, 
chemistry, microbiology, molecular b iology, nutrit ion, and toxicology supports the safety of pectin lyase from 
T. reesei  RF6199  for its requested uses.   Therefore, the Department has enabled the requested uses of pectin 
lyase from T. reesei  RF6199  by adding to the List of Permitted Food Enzymes  the new entr y shown in the 
above table.  
Other Relevant Information  
Food additives such as pectin lyase are required to meet food -grade specifications set out in Part B of the 
Regulations 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 standards for 
purity and identity 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 Consideration s 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.  
Implementation and Enforcement  
The above modification came i nto force September 23, 2022, the day it was published in 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.   Notice of Modification to the List of Permitted Food Enzymes  to Enable  the Use of Pectin Lyase from T. reesei RF6199  in Various Foods  
| 4 
 Contact Information  
Health Canada's Food Directorate is committed to reviewing new scientific informati on on the safety in use of 
any permitted  food additive, including pectin lyase from T. reesei  RF6199 .  Anyone wishing to submit an 
inquiry or new scientific information on the use of this additive may do so in writing, by regular mail or 
electronically.  I f you wish to contact the Food Directorate electro nically, please use the words " pectin lyase  
(NOM -0190)" 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  