Notice of Modification to the List of Permitted pH Adjusting Agents, Acid -Reacting Materials and Water Correcting Agents to  
Enable the Use of Calcium Carbonate as a pH Adjusting Agent in Infant Cereal Products   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     1 
  
Notice of Modification to the List of Permitted pH 
Adjusting Agents, Acid -Reacting Materials and Water 
Correcting Agents to Enable the Use of Calcium 
Carbonate as a pH Adjusting Agent in Infant Cereal 
Products  
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0047] 
 
 
 April 01, 201 5  
Notice of Modification to the List of Permitted pH Adjusting Agents, Acid -Reacting Materials and Water Correcting Agents to  
Enable the Use of Calcium Carbonate as a pH Adjusting Agent in Infant Cereal 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 MA’s and publis hed 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 premarket approval proc ess 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 calcium 
carbonate as a pH adjusting agent at use levels up to 2.52% weight/weight (w/w)  in infant cereal 
products.  
 
Calcium carbonate is already permitted for use in Canada a s a pH adjusting agent in 
unstandardized foods as well as in several standardized foods  at levels consistent with Good 
Manufacturing Practice.  
 
The results of Health Canada’s evaluation of available scientific data support the safety of 
calcium carbonate when used in infant cereal products as requested by the petitioner. The 
toxicological database also support s identifying a maximum level of use that is consistent with 
Good Manufacturing Practice . Therefore, Health Canada has modified the List of Permitted pH 
Adjusting Agents, Acid -Reacting Materials and Water Correcting Agents  to extend the use of 
calcium carbonate by adding the entry shown below to the List.   
 
Modification to the List of Permitted pH Adjusting Agents, Acid -Reacting Materials and 
Water Correcting Agents   
 
Item 
No. Column 1  
Additive  Column 2  
Permitted in or 
upon  Column 3  
Maximum Level of Use 
and Other Conditions  
C.2 Calcium 
Carbonate  (7) Infant cereal 
products  
 (7) Good Manufacturing  
Practice  
 
  
Rationale  
 
With respect to the maximum level of use for this additive, the ADI for calcium carbonate is “not 
limited”; generally, the maximum level of use for such additives can be established as “Good 
Manufacturing Practice" or GMP. This would be consistent with the position taken by Codex and 
current approved uses in the U.S., EU and Australia and New Zealand.   
Notice of Modification to the List of Permitted pH Adjusting Agents, Acid -Reacting Materials and Water Correcting Agents to  
Enable the Use of Calcium Carbonate as a pH Adjusting Agent in Infant Cereal Products   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3  
Health Canada’s Food Directorate completed a pre -market safety a ssessment of calcium 
carbona te. The assessment considered toxicological, nutritional and chemical aspects of calcium 
carbonate when used as requested in the food additive submission.     
 
Based on the results of the safety assessment, Health Canada’s Food Directorate considers that 
the data support the safety of calcium carbonate when used as requested by the petitioner . The 
Department has therefore enabled the use of calcium carbonate as described in the above table.  
 
Implementation and Enforcement  
 
The above modification came into force April  01, 2015 , the day it was published in List of 
Permitted pH Adjusting Agents, Acid -Reacting Materials and Water Correcting 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 permitted 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 words “ calcium carbonate " 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