Notice of Modification to the List of 
Permitted Food Enzymes  to Enable the 
Use of Pectin Lyase from Aspergillus 
niger  Rung373 in Various Standardized 
and Unstandardized Foods  
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM-0154 
September 23, 2020  
  
 
Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Pectin Lyase from A. nige r Rung373  in Various 
Standardized and Unstandard ized Foods – Reference Number: NOM -0154| 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 pectin 
lyase (a type of pectinase) from Aspergillus niger  Rung373 as a food enzyme  in apricot  nectar;  peach nectar; 
pear nectar ; cider; coffee; concentrated (naming the fruit) juice; distillers’ mash; natural flavour and colo ur 
extractives; single -strength fruit juices; skins of fruits destined for jam, marmalade, and candied fruit 
production; tea leaves for the production of tea solids; unstandardized fruit a nd vegetable products; 
unstandardized pomace; unstandardized purées; vegetable stock for use in soups; and wine .  The food 
enzyme is intended to be used at a level consistent w ith Good Manufacturing Practice .    
Several of the specific types of foods that the petitioner requested are included  in broader food categories as 
per the food additive list  below . Consequently, the use of pectin lyase from A. niger  Rung373 is permitted in 
these specific foods even though the y are not identified as such in the List of Permitted Food Enzymes : 
(1) The enzyme is not intended to be added directly to concentrated (naming the fruit) juice1 but is 
permitted to be present in it when the enzyme is used in manufacturing the single -strength fruit 
juice from which the concentrated juice is prepared . Therefore, there is only  an entry for  “Single -
strength fruit juices”  in the table below ; 
(2) The enzym e is permitted for use in “skins of citrus fruits destined for jam, marmalade and candied 
fruit production”, “vegetable stock for use in soups”, “unstandardized pomace” and “unstandardized 
purées”  by virtue of being permitted in “Unstandardized fruit and v egetable products” as shown  in 
the table below . 
Based on the information provided in the submission  and in accordance with the Food Directorate’s Policy for 
Differentiating Food Additives and Processing Aids ,2 the Food Directorate has deter mined that the use of 
pectin lyase from A. niger  Rung373 in coffee processing is a processing aid use of this enzyme  rather than a 
food additive  use. Consequently, a  modification to the List of Permitted Food Enzymes  is not required for this 
enzyme to be u sed in this application.  
Pectinase from other source s is already permitted for use in Canada as a food enzyme  in the foods that were  
added to the List of Permitted Food Enzymes  for pectin lyase  from A. niger  Rung373 , except apricot nectar, 
                                                             
1 There is a standard of composition for C oncentrated (naming the fruit) juice as per section B.11.130  of the 
Regulations.  
2 Information about food processing aids is available in the Policy for Differentiating Food Additives and Processing 
Aids . Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Pectin Lyase from A. nige r Rung373  in Various 
Standardized and Unstandard ized Foods – Reference Number: NOM -0154| 3 
 peach nectar and  pear nectar.  However, A. niger  Rung373 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 A. niger  Rung373  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 pectina se (specifically, the pectinase “pectin lyase”) by 
addi ng a new entry “(i) pectin lyase”  to column 1  for Item No. P.3  and adding  the following  entries in columns 
2, 3 and 4 shown below to the new entry (i) of Item No. P.3 in the  List.  
 
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  
(i) Pectin 
lyase  Aspergillus niger  Rung373  (1) 
Apricot nectar; Peach 
nectar; Pear nectar  (1) 
Good Manufacturing 
Practice  
(2) 
Cider; Wine  (2) 
Good Manufacturing 
Practice  
(3)  
Distillers’ Mash  (3) 
Good Manufacturing 
Practice  
(4)  
Natural flavour and 
colour extractives  (4) 
Good Manufacturing 
Practice  
(5)  
Single -strength fruit 
juices  (5) 
Good Manufacturing 
Practice  
(6)  
Tea leaves for the 
production of tea solids  (6) 
Good Manufacturing 
Practice  
(7)  
Unstandardized fruit and 
vegetable products  (7) 
Good Manufacturing 
Practice  
 
Rationale  
Health Canada’s Food Directorate completed a premarket safety assessment of pectin lyase  from A. niger  
Rung373  for use as a food enzyme .  The assessment conclud ed that information related to allergenicity, 
chemistry, microbiology, molecular b iology, nutrition, and toxicology supports the safety of pectin lyase from 
A. niger  Rung373  for its uses  shown in the table above .  Therefore, the Department has enabled the se uses of Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Pectin Lyase from A. nige r Rung373  in Various 
Standardized and Unstandard ized Foods – Reference Number: NOM -0154| 4 
 pectin lyase from A. niger  Rung373 by adding the new entr ies shown in th e above table  to the List of 
Permitted Food Enzymes . 
Other Relevant Information  
The Food and Drug Regulations  require that food additives such as pectin lyase from A. niger  Rung373 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 Comp endium 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 Orga nization of the United Nations.  
Implementation and Enforcement  
The above modification came into force September  23, 2020, 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 D rugs 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 pectin lyase from A. niger  Rung373 .  Anyone wishing to submit new 
scienti fic information on the use of this additive  or to submit any inquiries may do so in writing, by regular 
mail or electronically.  If you wish to contact the Food Directorate electro nically, please use the words " Pectin 
Lyase (NOM -0154)" 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: hc.bcs -bipc.sc@canada.ca