Health Canada’s Proposal to Enable the Use of a New Food Additive, Sodium Hydrogen Malate, as a Coating for Unstandardized 
Flavouring Preparations Used in Chewing Gum, Dry Beverage Mixes, Gelatin Dessert Powders and Unstandardized Confectionery   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     1 
  Health Canada’s Proposal to Enable the Use of a New Food 
Additive, Sodium Hydrogen Malate, as a Coating for 
Unstandardized Flavouring Preparations Used in Chewing 
Gum, Dry Beverage Mixes, Gelatin Dessert Powders and 
Unstandardized Confectionery  
Notice of Proposal  – Lists of Permitted Food Additives  
Reference Number: [ NOP/AV P-0013 ] 
 
March  4, 2016   
Health Canada’s Proposal to Enable the Use of a New Food Additive, Sodium Hydrogen Malate, as a Coating for Unstandardized 
Flavouring Preparations Used in Chewing Gum, Dry Beverage Mixes, Gelatin Dessert Powders and Unstandardized Confectionery   
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 .  Approved food additives and their 
permitted conditions of use are set out in  the Lists of Permitted Food Additives  that are 
incorporated by reference in the MAs and published on Health Canada’s 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 pre -market 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 a food additive submission seeking approval for the use of sodium 
hydrogen malate in an unstandardized flavouring preparation to be used in chewing gum, dry 
beverage mixes, unstandardized confectionery and gelatin dessert powders. Th e maximum level 
of use requested on the basis of the finished food , is 1.5% in the first three food categories and 
0.5% in gelatin dessert powders. The technical function of the sodium hydrogen malate is as a 
coating agent for the flavouring substance.  
 
The results of Health Canada’s evaluation of available scientific data support the safety and 
efficacy of sodium hydrogen malate when used as requested by the petitioner . Therefore, it is the 
intention of Health Canada to modify the List of Permitted Food Additives with Other Generally 
Accepted Uses  by adding the following item to the list.  
 
Proposed Modification to the List of Permitted Food Additives with Other Generally Acc epted 
Uses  
 
Item 
No. Column 1  
Additive  Column 2  
Permitted in or upon  Column 3  
Purpose of 
Use Column 4  
Maximum Level of 
Use and Other 
Conditions  
S.6.01  Sodium 
Hydrogen 
Malate  (1)  
Unstandardized flavouring 
preparations to be used in or 
upon chewing gum, dry 
beverage mixes or 
unstandardized 
confectionery   
 
(2) 
Unstandardized flavouring 
preparations to be used in or 
upon gelatin dessert powders  (1)  
Coating  
 
 
 
 
 
 
(2) 
Coating  
 (1)  
1.5% in the finished 
product  
 
 
 
 
 
(2) 
0.5% in the finished 
product  
  
Health Canada’s Proposal to Enable the Use of a New Food Additive, Sodium Hydrogen Malate, as a Coating for Unstandardized 
Flavouring Preparations Used in Chewing Gum, Dry Beverage Mixes, Gelatin Dessert Powders and Unstandardized Confectionery   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3  
Rationale  
 
Health Canada’s Food Directorate has completed its pre -market safety and efficacy assessment 
of sodium hydrogen malate . The assessment considered toxicological, chemical and technical 
aspects of sodium hydrogen malate when used as described abov e. The potential contribution of 
sodium from the proposed use was also evaluated from a nutritional perspective.  No food safety 
concerns were identified.   
 
The sodium hydrogen malate is used as a coating for such flavouring substances as organic acid 
whic h may be used to impart a tart, sour taste  to food. The sodium hydrogen malate creates a 
barrier between the flavouring and the food to which the flavouring is added, reducing the 
migration of the flavouring into the food matrix.  When the food is consumed,  the flavour is 
released as the sodium hydrogen malate dissolves in saliva. The dissolved sodium hydrogen 
malate itself also contributes to the flavour profile of the food.   
   
Based on the results of the safety assessment, Health Canada’s Food Directorat e considers that 
the data support the safety of sodium hydrogen malate when used under the conditions of u se set 
out in the table above. The Department is therefore proposing to enable the use of sodium 
hydrogen malate as described in the above table.  
  
Other Relevant Information  
 
Sodium hydrogen DL -malate (INS 350(i)) is listed in Table III of the Codex General Stand ard 
for Food Additives (GSFA). It may be used in a number of foods under the conditions of good 
manufacturing practice, including confection ery, chewing gum, water -based flavoured drinks, 
and fruit -flavoured gelatin.  
 
No information on permitted food uses, if any, for sodium hydrogen malate in the United States 
has be en identified. However, malic acid1 is identified as a direct food substance that has been 
affirmed as Generally Recognized as Safe (GRAS) as per Section 184.1069, Title 21 ( Food and 
Drugs ) of the U.S. Code of Federal Regulations . 
 
In the European Union, sodium malates (E 350), which includes sodium hydrogen malate 
(E 350(i)), are authorized for use at a maximum level of quantum satis  in various food categories 
including chewing gum, certain confectionery and certain desserts, and fl avoured drinks.  
 
Australia and New Zealand permit sodium malates (INS No. 350), which includes sodium 
hydrogen malate (350(i)), in various food categories including sugar confectionery (which 
includes chewing gum) and water based flavoured drinks in accord ance with good manufacturing 
practice.  
 
                                              
1 Sodium hydrogen malate is a salt of malic acid.   
Health Canada’s Proposal to Enable the Use of a New Food Additive, Sodium Hydrogen Malate, as a Coating for Unstandardized 
Flavouring Preparations Used in Chewing Gum, Dry Beverage Mixes, Gelatin Dessert Powders and Unstandardized Confectionery   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4 The Canadian Food and Drug Regulations require that food additives such as sodium hydrogen 
malate, which do not have specifications set out in the Regulations, meet the food -grade 
specifications set out in the most r ecent edition of the Food Chemicals Codex (FCC). The FCC is 
a compendium of standards for purity and identity for food ingredients, including food additives, 
which is published by the U .S. Pharmacopeial Convention.  
 
Implementation and Enforcement  
 
The proposed changes will be effective the day on which they are published in the List of 
Permitted Food Additives with Other Generally Accepted Uses . This will be announced via a 
Notice of Modification which will be published on Health Canada’s Website .  
 
The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs 
Act and its associated regulations with respect to foods.   
 
Corrective Modifications to the Liste des additifs alimentaires ayant d’autres utilisations 
généralement acceptées  
 
In the French list, the term “coating” was variously translated using one of the f our following 
terms:  couverture, enrob er, badigeonner, and enrobage. A corrective modification will be made 
to items A.1, M.3(3), M.7(2), P.1A(1), P.1A(2), P.2(2) in column 3 of the Liste des additifs 
alimentaires ayant d’autres utilisations généralement acceptées  in order to consistently use the 
single term «  enrobage  » for the English term “coating”.  
 
Contact Information  
 
For additional information or to submit comments related to this proposal, please contact:   
 
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  
 
If communicating by e -mail, please use the words “ Sodium Hydrogen Malate ” in the subject 
line of your e -mail.  Health Canada is able to consider information received by May 17, 2016 , 75 
days from the date of this posting.