Notice of Modification to the List of Permitted Colouring Agents  to Enab le the Use of  
Calcium  Carbonate in Unstandardized Confectionery    
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    1 
 
  Notice of Modification to the List of Permitted 
Colouring Agents  to Enable the Use of Calcium 
Carbonate  in Unstandardized Confectionery   
 
Notice of Modification  – Lists of Permitted Food Additives  
Reference Number: [NO M/ADM-0124] 
September  6, 2018  Notice of Modification to the List of Permitted Colouring Agents  to Enab le the Use of  
Calcium  Carbonate in 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  (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 foo d 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 calcium carbonate  as a colouring agent  in hard and soft candies  and in inks for writing on 
various confections . The proposed maximum levels of use are 1% by weight in confectionery 
and 0.05% by weight in the final inked confections . The confections of interest are 
unstandardized foods.  
 
Calcium carbonate already  has a number of permitted  uses as a food additive  as shown  in the List 
of Permitted Emulsifying, Gelling, Stabilizing or Thickeni ng Agents , the List of Permitted Food 
Additives with Other Accepted Uses , the List of Permitted pH Adjusting Agents, Acid -Reacting 
Materials and Water Correcting Agents , and the List of Permitted Yeast Foods . It may also be 
added to flour as a source of calcium.1 
 
The Food Directorate concluded that information related to the safety of calcium carbonate  
supports its use in or on unstandardized confectionery as requested by the petitioner  at a level 
consistent with Good Manufacturing Practice .  Therefore, Health Canada h as enabled the 
requested uses of calcium carbonate  by adding the entry shown in the table below to the List of  
Permitted Colouring Agents .  
 
Modification to the List of Permitted  Colouring Agents  
 
Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon Column 3  
Maximum Level of Use and 
Other Conditions  
14 Calcium 
Carbonate  Unstandardized confectionery  Good Manufacturing Practice  
 
  
                                              
1 As per paragraph B.13.001( f) of the Food and Drug Regulations . Notice of Modification to the List of Permitted Colouring Agents  to Enab le the Use of  
Calcium  Carbonate in Unstandardized Confectionery    
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    3 Rationale  
 
The Food Directorate completed a pre market safety assessment of the requested uses of calcium 
carbonate .  The assessment concluded that information related to  chemistry, nutrition, and 
toxicolog y support the safety of calcium carbonate for its requested uses .  Therefore, Health 
Canada  has enabled the requested uses of calcium carbonate by modifying the List of Permitted 
Colouring Agents  as shown  in the above table.  
 
Other Relevant Information  
 
The Food and Drug Regulations  require that food additives such as calcium carbonate  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 c ompendium 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 
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 September  6, 2018 , the day it was published in  the List 
of Permitted Colouring Agents . 
 
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 calcium carbonate .  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 word s "Calcium Carbonate  (NOM -0124)" 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: hc.publications -publications.sc@canada.ca