Health Canada’s Proposal to Enable the Use of Ground  Limestone  
as a Colouring Agent  in Unstandardized Confectionery   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    1 
  
Health Canada’s Proposal to Enable the Use 
of Ground Limestone  as a Colouring Agent  in 
Unstandardized Confectionery  
 
Notice of Proposal – Lists of Permitted Food Additives  
Reference Number: NOP/A DP-0029 
October 4, 2018 Health Canada’s Proposal to Enable the Use of Ground  Limestone  
as a Colouring Agent  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 Permitted Food Additives  that are 
incorporated by refere nce 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 food additive submission with the Department’s Food 
Direct orate. 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 received a food additive submission seeking  approval for the use of ground 
limestone as a colouring agent in hard and soft candies and in edible inks for writing on certain 
confectioneries. The proposed maximum levels of use are 1% by weight in the confectionery 
(i.e., the hard and soft candies) an d 0.05% by weight in the final inked confectionery. The 
confectioneries of interest are considered to be unstandardized foods.  
 
Ground limestone consists primarily of calcium carbonate, but can contain other minerals. While 
calcium carbonate is already permitted for use as a colouring agent for the same uses that are 
requested for ground limestone, Health Canada considers ground limestone to be distinct from 
calcium carbonate since the two substances have separate food -grade specifications.1 Ground 
limes tone does not currently have any permitted uses as a food additive (i.e., it is a “new” food 
additive in Canada). It may, however, be added to flour as a source of calcium.2 
 
The results of Health Canada’s evaluation of the scientific information support the safety and 
efficacy of ground limestone when used in the foods requested by the petitioner at a level 
consistent with Good Manufacturing Practice. Therefore, Health Canada proposes to enable this 
use of ground limestone by adding an entry for ground limestone to column 1 of item no. 14 of 
the List of Permitted Colouring Agents  as shown in the table below. This listing accommodates 
its use in edible inks on confectionery as the ink is considered part of the confectionery once 
applied.  
 
Proposed 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 Ground Limestone  Unstandardized confectionery  Good Manufacturing Practice  
 
                                              
1 For example, the Food Chemicals Codex  (11th edition, first supplement) specifies that the minimum calcium 
content, on the dried basis, of ground limestone is 94.0% and of calcium carbonate is 98.0%.  
2 See section B.13.001( f) of the Food and Drug Regulations . Health Canada’s Proposal to Enable the Use of Ground  Limestone  
as a Colouring Agent  in Unstandardized Confectionery   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    3 Rationale  
 
The Food Directorate completed a premarket safety and efficacy assessment of the requested use 
of ground limestone. The assessment considered the information related to the toxicological, 
nutritional, chemical and technical aspects of ground limestone for its requested use.      
 
The primary constituent of ground limestone  is calcium carbonate, which  dissociate s into 
calcium ions and carbonate ions  in the acidic environment  of the human stomach .   
 
Calcium  and carbonate are normal constituent s of the human b ody. Calcium in particular is an 
essential nutrient. After intestinal absorption, calcium  enter s normal metabolic pathways and is 
stored by the body , for example in bones,  with excess calcium being  excreted  in urine and feces . 
Carbonate ions are also absorbed and are excreted as carbon dioxide  and do not accumulate in 
the body .   
 
The proposed use of g round limestone would  not contribute a significant amount of calcium  to 
the diet, and there are no food safety concerns with the additional intake of carbonate from the 
proposed use of ground limestone .  
 
The results of the premarket safety assessment  support the safety of ground limestone for use  as 
a colouring agent as s et out in the table above . Health Canada is therefore propos ing to enable 
this use of ground limestone as shown in the table .  
  
Other Relevant Information  
 
The Food and Drug Regulations  require that food additives such as ground limestone  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 co mpendium 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 proposed change will be effective the day on which it is published  in the List of Permitted 
Colouring Agents . This will be announced via a Notice of Modification that will be published on 
the Government of Canada ’s Website .  
 
The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs 
Act and its associated regu lations with respect to foods.  
 Health Canada’s Proposal to Enable the Use of Ground  Limestone  
as a Colouring Agent  in Unstandardized Confectionery   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    4 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 Past ure, PL: 2202C  
Ottawa, Ontario K1A 0L2  
E-mail: hc.bcs -bipc.sc@canada.ca  
 
If communicating by e -mail, please use the words “ Ground Limestone  (NOP -0029)” in the 
subject line of your e -mail.   Health Canada is able to consider information received by 
December 1 7, 2018 , 75 days from the date of this posting.