Notice of Modification to the List of Permitted Food Additives with Other Generally Accepted Uses to Enable the Use of  Sodium  
Hydrogen Malate as a Coating for Unstandardized Flavouring Preparations Used in Chewing Gum, Dry Beverage Mixes,  
Gelatin Dessert Powders and Unstandardized C onfectionery   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     1 
  
Notice of Modification to the List of Permitted Food 
Additives with Other Generally Accepted Uses to Enable 
the Use of  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 Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0075] 
 
 
 July 7, 2016   
Notice of Modification to the List of Permitted Food Additives with Other Generally Accepted Uses to Enable the Use of  Sodium  
Hydrogen Malate as a Coating for Unstandardized Flavouring Preparations Used in Chewing Gum, Dry Beverage Mixes,  
Gelatin Dessert Powders and Unstandardized C onfectionery   
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 th eir 
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 petitio ner 
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 approval process to det ermine 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. The maximum level 
of use on the basis of the finishe d 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 scientif ic data support the safety and 
efficacy of sodium hydrogen malate when used as requested by the petitioner. Since this is a 
food additive that was not previously permitted for use in Canada, Health Canada published a 
Notice of 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 Unsta ndardized Confectionery  - Reference Number: 
NOP/AVP -0013  on March 4, 2016, requesting comments. No new scientific information was 
submitted to the Department as a result of this publication. Since the conclusions of the 
evaluation remain as described in th e publication, Health Canada has modified the List of 
Permitted Food Additives with Other Generally Accepted Uses  as indicated below.   
 
Modification to the List of Permi tted Food Additives with Other Generally Accepted Uses  
 
Item 
No. Column 1  
Additive  Column 3  
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 (1) Coating  
 (1) 1.5% in the 
finished product   
Notice of Modification to the List of Permitted Food Additives with Other Generally Accepted Uses to Enable the Use of  Sodium  
Hydrogen Malate as a Coating for Unstandardized Flavouring Preparations Used in Chewing Gum, Dry Beverage Mixes,  
Gelatin Dessert Powders and Unstandardized C onfectionery   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 unstandardized 
confectionery  
(2) Unstandardized 
flavouring 
preparations to 
be used in or 
upon gelatin 
dessert powders  
 (2) Coating  
 (2) 0.5% in the 
finished product  
 
Rationale  
 
Health Canada’s Food Directorate completed a premarket safety and efficacy assessment of 
sodium hydrogen malate. The assessment considered toxicological, chemical and technical 
aspects of sodium hydrogen malate when used as described above. The potential contribution of 
sodium from the proposed use was also evaluated from a nutritional perspective. No food safety 
concerns were identified.  
 
The intended use of sodium hydrogen malate is as a coating for such flavouring substances as 
organic acid which 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 mi gration 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.   
   
Base d on the results of the safety assessment, Health Canada’s Food Directorate considers that 
the data support the safety of sodium hydrogen malate when used under the conditions of use set 
out in the table above.  The Department has therefore enabled 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 3 of the Codex General Standard for 
Food Additives (GSFA).  It may be used in a number of foods under the conditions of good 
manufacturing practice, including confectionery, 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 been 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 . 
 
                                              
1 Sodium hydrogen malate is a salt of malic acid.   
Notice of Modification to the List of Permitted Food Additives with Other Generally Accepted Uses to Enable the Use of  Sodium  
Hydrogen Malate as a Coating for Unstandardized Flavouring Preparations Used in Chewing Gum, Dry Beverage Mixes,  
Gelatin Dessert Powders and Unstandardized C onfectionery   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4 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 flavoured drinks.  
 
Australia and New Ze aland 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 accordance with good manufacturing 
practice . 
 
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 recent edition of the Food Chemicals C odex (FCC). The FCC is 
a compendium of standards for purity and identity for food ingredients, including food additives, 
which is published by the United States Pharmacopeial Convention.  
 
Corrective modifications to the Liste des additifs alimentaires ayan t d’autres utilisations 
généralement acceptées  
 
In the French list, the term “coating” was variously translated using one of the four following 
terms:  couverture, enrober, badigeonner and enrobage .  A corrective modification has been 
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”.  
 
Notification – Summary of Comments  
 
No comments were received in response to the Notice of 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  - Reference Number: NOP/AVP -0013 , published on March 4, 
2016.  
 
Implementation  and Enforcement  
 
The above modification came into force July 7, 2016 , the day it was published in  the List of 
Permitted Food Additives with Other Generally Accepted Uses . 
 
The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs 
Act and its associated regulations with respect to foods.  
 
 
 
  
Notice of Modification to the List of Permitted Food Additives with Other Generally Accepted Uses to Enable the Use of  Sodium  
Hydrogen Malate as a Coating for Unstandardized Flavouring Preparations Used in Chewing Gum, Dry Beverage Mixes,  
Gelatin Dessert Powders and Unstandardized C onfectionery   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     5 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 sodium hydrogen malate . 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 electron ically. If you wish to contact the Food Directorate 
electronically, please use the words " sodium hydrogen malate " 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