Notice of Modification to the List of Permitted Colouring Agents  to Enable the Use of Ground Limestone 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 
Ground Limestone  in Unstandardized 
Confectionery  
 
Notice of Modification  – Lists of Permitted Food Additives  
Reference Number: NOM/ADM-0129 
March 20 , 2019   
Notice of Modification to the List of Permitted Colouring Agents  to Enable the Use of Ground Limestone 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 Per mitted 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 food 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.  
 
Heal th Canada ’s Food Directorate  received a food additive submission seeking approval for the 
use of ground limestone  as a colouring agent  in hard and soft candies and in inks for writing on 
various  confection s. The proposed maximum levels of use are 1% by weight in confectionery  
and 0.05% by weight in the final inked confection s. The confection s of interest are 
unstandardized foods.     
 
The results of the Food Directorate ’s evaluation of available scie ntific data support the safety and 
efficacy  of ground limestone  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 Health Canada’s Proposal to Enable the Use of Ground Limestone as a Colouring Agent in 
Unstandardized Confectionery  [NOP/ADP -0029]  on October 4, 2018 , which was open to the 
public for comment for 75 days . 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 the 
publication, Health Canada has enabled the requested uses of ground limestone 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. Ground 
Limestone  Unstandardized Confectionery  Good Manufacturing Practice  
 
 
Rationale  
 
Health Canada’s F ood Directorate completed a pre market safety and efficacy assessment of the 
requested uses of ground limestone .  The assessment concluded that information related to  
chemistry, microbiolog y, nutrition, toxicolog y, and allergenicity  support s the safety of  ground 
limestone for  its requested uses.  Therefore, the Department has enabled the requested uses of  
Notice of Modification to the List of Permitted Colouring Agents  to Enable the Use of Ground Limestone in 
Unstandardized Confectionery  
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    3 ground limestone  by adding to  the List of Permitted Colouring Agents  the new item number and 
its corresponding entries as shown  in the above table.  
 
Other Relevant Information  
 
The Food and Drug Regulations  require that food additives 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 compendium of standards for purity and identity 
for food ingredients, including food additives, published by the United States Pharmacopeial 
Conventio n. 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.  In the case of 
limestone, its food-grade specifications can be found in the Food Chemicals Codex .   
 
Notification – Summary of Comments  
 
No comments were received i n response to Health Canada’s Proposal to Enable the Use of 
Ground Limestone as a Colouring Agent in Unstandardized Confectionery , published on October 
4, 2018.  
  
Implementation and Enforcement  
 
The above modification came into force March 20 , 2019, the day it was published in the List of 
Permitted Colouring Agents . 
 
The Canadian Food Inspection Agency is responsible for the enforcement of t he 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 ground limestone .  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 "Ground Limestone  (NOM -0129)" in the subject line of 
your e -mail.  
 
Bureau of C hemical Safety, Food Directorate  
251 Sir Frederick Banting Driveway  
Tunney’s Pasture, PL: 2202C  
Ottawa, Ontario K1A 0L2  
E-mail: hc.bcs -bipc.sc@canada.ca