Notice of Modification to the List of Permitted Preservatives  to Enable the Use of  
Tocopherols in Dehydrated Fish Broth and Dehydrated Mollusc Broth   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    1 
  
Notice of Modification to the List of Permitted 
Preservatives  to Enable the Use of 
Tocopherols in Dehydrated Fish Broth and 
Dehydrated Mollusc Broth  
 
Notice of Modification  – Lists of Permitted Food Additives  
Reference Number: NOM/ADM-0136 
August  8, 2019  
Notice of Modification to the List of Permitted Preservatives  to Enable the Use of  
Tocopherols in Dehydrated Fish Broth and Dehydrated Mollusc Broth   
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 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 s 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 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 tocopherols  as a preservative at a maximum level of use of 37 ppm in dehydrated fish 
broth and dehydrated  clam broth.  The Food Directorate considered  a maximum level of use of 50 
ppm in the reconstituted broth in order to be consistent with the provision in the  CODEX 
Standard for Bouillons and Consommés1 that permits 50 ppm of mixed tocopherols concentrate 
and alpha -tocopherols, singly or in combinatio n, in foods that are subject to the standard.    
 
The use of tocopherols2 as an antioxidant is already permitted in Canada in several foods at a 
maximum level consistent with Good Manufacturing Practice.  An amendment3 to the Marketing 
Authorization for Foo d Additives that May be Used as Preservatives  was required to exempt 
from the general prohibition set out in paragraph B.21.005(b) of the Regulations  on the sale of 
fish and meat products or preparations  containing preservatives.  
 
The results of the Food Directorate’s evaluation of available scientific data support the safety of 
tocopherols when used at 50 ppm as a preservative in dehydrated fish broth  or dehydrated 
mollusc  broth. Therefore, Health Canada has modified Part 4 of the List of Permitted 
Preservatives  to enable the use of tocopherols in dehydrated fish broth and dehydrated mollusc 
broth by addin g the entry shown b elow to the list.  
 
Modification to Part 4 of the List of Permitted Preservatives  
 
Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon Column 3  
Maximum Level of Use 
and Other Conditions  
T.2 Tocopherols (alpha -
tocopherol; tocopherols 
concentrate, mixed)  (7) 
Dehydrated fish broth; 
Dehydrated mollusc broth  (7) 
50 p.p.m. in the 
reconstituted broth  
                                              
1 CODEX STAN 117 -1981 , Revision: 2001 and 2015.  
2 As per item no. T.2 of Part 4 of the List of Permitted Preservatives , tocopherols  are alpha -tocopherol and/or 
tocopherols concentrate, mixed.  
3 As per Canada Gazette Part II , Volume 153, Number 13 . SOR/2019 -210 June 14, 2019.   
Notice of Modification to the List of Permitted Preservatives  to Enable the Use of  
Tocopherols in Dehydrated Fish Broth and Dehydrated Mollusc Broth   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    3 Rationale  
 
Health Canada’s F ood Directorate completed a pre market safety assessment of  tocopherols for 
use as a preservative in dehydrated fish broth and dehydrated mollusc broth . The assessment 
concluded that information related to  chemistry, microbiolog y, nutrition, and toxicolog y supports 
the safety of tocopherols  for its  requested uses.  Therefore, the Department has enabled the 
requested uses of tocopherols  by adding to  Part 4 of  the List of Permitted Preservatives  the new  
entry  shown  in the above table.  
 
Other Relevant Information  
 
The Food and Drug Regulations  require that food additives such as tocopherols  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 compendium of standards for purity and 
identity for food ingredients, including food add itives, published by the United States 
Pharmacopeial Convention. The Combined Compendium of Food Additive Specifications , which 
contains specifications prepared by the Joint FAO/WHO Expert Committee on Food Additives 
(JECFA) , is published by the Food and Agriculture Organization of the United Nations.   
 
Implementation and Enforcement  
 
The above modification came into force August  8, 2019, the day it was published in  Part 4 of  the 
List of Permitted Preservatives . 
 
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 tocopherols . Anyo ne 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 " Tocopherols  in Fish and Mollusc Broth (NOM -0136)" in the subject 
line of your e -mail.  
 
Burea u of Chemical Safety, Food Directorate  
251 Sir Frederick Banting Driveway  
Tunney’s Pasture, PL: 2202C  
Ottawa, Ontario K1A 0L2  
E-mail: hc.bcs -bipc.sc@canada.ca