Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Pectinase  from  
Trichoderma reesei  RF6197 and from Trichoderma reesei  RF6201  in Single -strength Fruit Juices,  
Wine, and Unstandardized Fruit and Vegetable Products   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    1 
  
Notice of Modification to the List of Permitted Food 
Enzymes  to Enable the Use of Pectinase from Trichoderma 
reesei RF6197 and from Trich oderma reesei  RF6201  in 
Single -strength Fruit  Juices , Wine  and Unstandardized 
Fruit and Vegetable Products  
 
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: NOM/ADM -0109 
February 1 , 2018 Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Pectinase  from  
Trichoderma reesei  RF6197 and from Trichoderma reesei  RF6201  in Single -strength Fruit Juices,  
Wine, and Unstandardized Fruit and Vegetable Products   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    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 received two food additive submission s seeking approval for the use of 
polygalacturonase from Trichoderma reesei  RF6197  and p ectin esterase from Trichoderma 
reesei  RF6201 , respectively, in the manufacture of single -strength  fruit juices, wine , fruit purées, 
vegetable purées , and fruit spreads .  The requested maximum level of use for each enzyme  is 
Good Manufacturing Practice (GMP).  
 
Polygalact uronase and pectin esterase are  types of pectinase.1,2  Pectinase from several  microbial 
sources  is already permitted for use  as a food enzyme  in the manufacture of wine and single -
strength fruit juices .  Pectinase from one of the se source  organism s is also permitted broadly in  
unstandardized fruit and vegetable products , a food category that include s fruit purées , vegetable 
purées  and unstandardized fruit spreads .   
 
Health Canada  determined that information related to the safety of pectinase  from Trichoderma 
reesei  RF6197 and from Trichoderma reesei  RF6201  supports their use in the manufacture of 
single -strength fruit juices, wine and unstandardized fruit and vegetable products .  Therefore, 
Health Canada has enabled their use by modifying the List of Permitted Food Enzymes  to include 
the entries shown in the  table below . 
 
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 Pectinase  Trichoderma 
reesei  RF6197; 
Trichoderma 
reesei  RF6201  (1) 
Single -strength fruit juices  (1) 
Good Manufacturing Practice  
(2) 
Unstandardized fruit and (2) 
Good Manufacturing Practice  
                                              
1 Garg, G. et al.  “Microbial Pectinases: An Ecofriendly Tool of Nature for Industries.” 3 Biotech 6.1 (2016): 47. 
[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4746199/ ] 
2 Chapter 11 of “Enzymes in Food Technology”, edited by Robert J. Whitehurst and Maarteen van Oort, second 
edition, 2010.  Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Pectinase  from  
Trichoderma reesei  RF6197 and from Trichoderma reesei  RF6201  in Single -strength Fruit Juices,  
Wine, and Unstandardized Fruit and Vegetable Products   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    3 Item 
No. Column 1  
Additive  Column 2  
Permitted 
Source  Column 3  
Permitted in or Upon  Column 4  
Maximum Level of Use and 
Other Conditions  
vegetable products  
(3) 
Wine  (3) 
Good Manufacturing Practice  
 
Corrective Modification  
 
To maintain the convention in the English version of the Lists of Permitted Food Additives of 
listing food additives in alphabetical order, the entry for  phospholipase in the List of Permitted 
Food Enzymes  has been  moved to a new item number, P.5.2. , and item number P.5A has been 
removed from the List.   Phospholipase now appear s after peroxidase (item no. P.5.1) and before 
protease (item no. P.6).  This corrective modification has no impact on the permitted food uses of 
phospholipase or any other permitted food enzyme.  
 
Rationale  
 
Health Canada’s F ood Directorate completed a pre market safety assessment of the requested 
uses of pectinase (as polygalacturonase ) from Trichoderma reesei  RF6197 and pectinase (as 
pectin esterase ) from Trichoderma reesei  RF6201 .  The assessment did not identify any 
chemical, microbiological, molecular biological, nutritional or toxicological  concerns .  
Therefore, the Department has enabled the requested uses of these two pectinases  by modifying 
the List of Permitted Food Enzymes  as shown in the above table.  
 
Other Relevant Information  
 
The Food and Drug Regulations  require that food additives such as pectinase  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 Chemi cals 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  contain 
specifications  prepared by the Joint FAO/WHO Expert Committee on Food Additives (JECFA)  
and are published by the Food and Agriculture Organization of the United Nations.  
  
Implementation and Enforcement  
 
The above modification came into force February 1, 2018 , the day it was published in the List 
of Permitted Food Enzymes . 
 Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Pectinase  from  
Trichoderma reesei  RF6197 and from Trichoderma reesei  RF6201  in Single -strength Fruit Juices,  
Wine, and Unstandardized Fruit and Vegetable Products   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    4 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  
 
Health Canada's Food Directorate is committed to reviewing any new scientific information on 
the safety in use of any food additive, including pectinase  from Trichoderma reesei  RF6197 or 
from Trichoderma reesei  RF6201 .  Anyone wishing to submit new scientific information on the 
use of these additives 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 
"pectin ase ( NOM /ADM -0109)" 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 0L2  
E-mail: bcs-bipc@hc -sc.gc.ca