Notice of Modification to the List of Permitted Preservatives  to Enable the Use of Potassium Lactate and Sodium Lactate  
as Preservatives in  Unstandardized and Certain Standardized Marine and Fresh Water Animal Products   
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 Potassium Lactate and 
Sodium Lactate as Preservatives in  Unstandardized and 
Certain Standardized Marine and Fresh Water Animal 
Products  
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0064] 
 
 
 January  8, 2016   
Notice of Modification to the List of Permitted Preservatives  to Enable the Use of Potassium Lactate and Sodium Lactate  
as Preservatives in  Unstandardized and Certain Standardized Marine and Fresh Water Animal Products   
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 n ew 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 th e 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 potassium 
lactate and sodium lactate as antimicrobial preservatives at a maximum leve l of use consistent 
with Good Manufacturing Practice in unstandardized marine and fresh water animal products 
and certain standardized marine and fresh water animal products .  Potassium lactate and sodium 
lactate are already permitted for use in Canada as preservatives in the List of Permitted 
Preservatives .   
 
The results of Health Canada’s evaluation of available scientific data support the safety and 
efficacy of potassium lactate and sodium lactate when used as set out in the table below.  
Therefore, Health Canada has modified the  List of Permitted Preservatives  to extend the use of 
potassium lactate and sodium lactate by adding the entries shown below to Part 2 of the List .   
 
Modification to Part 2 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  
P.2.1  Potassium 
Lactate  (3)  
Prepared fish or prepared meat, 
except canned prepared fish and 
canned prepared meat (Division 
21); Preserved fish or preserved 
meat (Division 21)  
 (3) 
Good Manufacturing 
Practice  
 
 
 
 
(4)  
Unstandardized preparations of  
(a) meat (Division 21); and  
(b) fish  (4) 
Good Manufacturing 
Practice  
 
S.2.2  Sodium  
Lactate  (3)  
Prepared fish or prepared meat, (3) 
Good Manufacturing  
Notice of Modification to the List of Permitted Preservatives  to Enable the Use of Potassium Lactate and Sodium Lactate  
as Preservatives in  Unstandardized and Certain Standardized Marine and Fresh Water Animal Products   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 except canned prepared fish and 
canned prepared meat (Division 
21); Preserved fish or preserved 
meat (Division 21)  
 Practice  
 
(4) 
Unstandardized preparations of  
(a) meat (Division 21); and  
(b) fish  (4) 
Good Manufacturing 
Practice  
 
 
 
Rationale  
 
Health Canada’s Food Directorate completed a pre -market safety and efficacy assessment of the 
requested use of potassium lactate and sodium lactate.  The assessment considered 
microbiological, toxicological, nutritional, chemical and technical aspects of p otassium lactate 
and sodium lactate, and found that the requested uses are acceptable from a food safety 
perspective. Therefore, the Department has enabled the requested uses of potassium lactate and 
sodium lactate by modifying Part 2 of the List of Permit ted Preservatives  as described in the 
above table.  
 
Other Relevant Information  
 
The new permitted uses of potassium lactate and sodium lactate in Canada are similar to 
permitted uses of these additives in Australia and New Zealand, Europe, and the United States of 
America. The international Codex system has not associated either potassium lactate or sodium 
lactate with the “preservative” functional class, but the Codex General Standard for Food 
Additives recognizes the use of both additives in certain proc essed fish and seafood products in 
accordance with Good Manufacturing Practice.   
 
The Food and Drug Regulations require that food additives such as potassium lactate and 
sodium lactate, 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 Codex (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.  
 
There are general labelling provisions requiring the declaration of ingredients, including 
food additives, in pre -packaged foods sold in Canada.  In the case where a food product 
contains added sodium -containing ingredients such as sodium lactate or added potassium -
containing ingredients such as potassium lactate,  Health Canada recommends that 
manufacturers or retailers, as the case may be, voluntarily make information regarding 
the presence and amount of added sodium and potassiu m available to consumers to assist 
those individuals who for health reasons may need to monitor their dietary intake of  
Notice of Modification to the List of Permitted Preservatives  to Enable the Use of Potassium Lactate and Sodium Lactate  
as Preservatives in  Unstandardized and Certain Standardized Marine and Fresh Water Animal Products   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4 sodium or potassium.  
 
With respect to pre -packaged products that are required to carry a Nutrition Facts table (NFt), the 
NFt includes t he mandatory declaration of the amount of sodium per serving and the percent 
contribution of that serving to the “daily value” for sodium.  Companies using potassium -
containing ingredients such as potassium lactate are strongly encouraged by Health Canada to 
voluntarily include the amount of potassium, as well as the percentage of the “daily value” for 
potassium, in the NFt in order to provide information to assist consumers in making informed 
choices.   
 
Implementation and Enforcement  
 
The above modification came into force January 8, 2016 , the day it was published in  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 info rmation on 
the safety in use of any food additive, including potassium lactate and sodium lactate . Anyone 
wishing to submit new scientifi c information on the use of th ese additive s 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 “ potassium lactate and sodium l actate ” 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