Notice of Modification to the List of Permitted Food Enzyme s to Enable the Use of  
Mannanase from Aspergillus niger  AE-HCM  in Liquid Coffee Concentrate  
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    1 
  
Notice of Modification to the List of Permitted 
Food Enzyme s to Enable the Use of 
Mannanase from Aspergillus niger  AE-HCM 
in Liquid Coffee Concentrate   
Notice of Modification  – Lists  of Permitted Food Additives  
Reference Number: NOM/ADM -0103 
September 14, 2017  
Notice of Modification to the List of Permitted Food Enzyme s to Enable the Use of  
Mannanase from Aspergillus niger  AE-HCM  in Liquid Coffee Concentrate  
  
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 food additive submission with the Department's Food 
Directorate.  Health Canada uses this premarket ap proval 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 a food additive submission seeking approval for the use of  mannanase  
from Aspergillus niger  AE-HCM  in the manufacture of liquid coffee concentrate . The 
mannanase enzyme is intended to be used to increase  the processing efficiency and stability of 
these concentrates by break ing down mannan s that are naturally present in coffee  but w hich can 
form a gel  during processing and storage .  
 
Mannanase is a type of  hemicellulase enzyme.  Hemicellulase s from Bacillus amyloliquefaciens  
and from Bacillus subtilis  are already permitted for use in the manufacture of liquid coffee 
concentrate.    
  
The results of Health Canada’s evaluation of available scientific information  support the safety 
and efficacy of mannanase from A. niger  AE-HCM for use in the manufacture of liquid coffee 
concentrate at a maximum level of use consistent with Good Manufacturing Practice (GMP) .  
Therefore, Health Canada has modified the List of Permitted Food Enzymes  to extend the u se of 
mannanase , a hemicellul ase, from A. niger  AE-HCM  by adding the entry shown below to 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  
M.01  Mannanase  Aspergillus niger  
AE-HCM  Liquid coffee  
concentrate  Good Manufacturing 
Practice  
 
Rationale  
 
Health Canada’s F ood Directorate completed a pre market safety assessment of the requested use 
of mannanase from A. niger  AE-HCM .  The assessment did not identify any chemical , 
microbiological, molecular biological, nutritional , or toxicological safety concerns with respect 
to the requested use of mannanase from A. niger  AE-HCM.  Therefore, the Department has  
Notice of Modification to the List of Permitted Food Enzyme s to Enable the Use of  
Mannanase from Aspergillus niger  AE-HCM  in Liquid Coffee Concentrate  
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    3 enabled the requested use of this enzyme from this source 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 mannanase  from A. niger  
AE-HCM  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 Chemicals Codex  or the Combined 
Compendium of Food Additive Specifications .  The Food Chemicals Codex  is a co mpendium 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 , which includes the General Specifications and C onsiderations for Enzyme 
Preparations , contains specifications that are prepared by the Joint FAO/WHO Expert 
Committee on Food Additives (JECFA) and published by the Food and Agriculture Organization 
of the United Nations.  
 
Implementation and Enforcement  
 
The above modification came into force September 14, 2017 , the day it was published in the 
List of Permitted Food Enz ymes . 
 
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  mannanase from A. niger  AE-HCM .  Anyone 
wishing to submit new scientific 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 electronically, please use the words " mannanase " 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