Notice of Modification to the List of Permitted Food Additives  with Other Accepted Uses  
to Enable the Use of Copper Sulphate  in Preserved Duck Egg s  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    1 
  
Notice of Modification to the List of Permitted 
Food Additives  with Other Accepted Uses  to 
Enable the Use of Copper Sulphate  in 
Preserved Duck Egg s 
 
Notice of Modification  – Lists of Permitted Food Additives  
Reference Number: [NO M/ADM-0106] 
October 6, 2017 Notice of Modification to the List of Permitted Food Additives  with Other Accepted Uses  
to Enable the Use of Copper Sulphate  in Preserved Duck Egg s  
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 by Health Canada 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. 
 Health Canada received a food additive submission seeking approval for the use of copper sulphate  in the manufactur e of preserved duck egg s (also known as century egg s, 100 -year-eggs, 
or 1000- year-old egg s
1).  The copper sulphate is to be added to the alkaline soaking solution 
used to manufacture preserved duck eggs  in such quantity that the content of copper in the edible 
portion of the finished preserved egg does not exceed 0.0005% .  The maximum limit of 0.000 5% 
copper in the edible portion of the finished egg is for copper from all sour ces, including copper 
sulphate.  The manufacturing process for preserved duck eggs involves  soak ing the raw eggs in a n alkaline 
solution for a period of time .  The eggs are removed  from the soaking solution, dried and 
packaged with the shell on.  The addition of copper sulphate to the soaking solution is intended to improve consistency in achieving the desired characteristics of the finished product.  
 Copper sulphate is already permitted for use in Canada as a fining agent in wine.   
 The results of Health Canada’s evaluation of available scientific data support the safety  of copper 
sulphate for use in the processing of preserved duck eggs .  Therefore, Health Canada has 
modified the List  of Permitted Food Additives with Other Accepted Uses
 to extend the use of 
copper sulphate  by adding the entry shown below to the list . 
 
Modification to the List of Permitted Food Additives with Other Accepted Uses  
Item 
No. Column 1  
Additive  Column 2  
Permitted in 
or Upon Column 3  
Purpose of use  Column 4  
Maximum Level of Use and 
Other Conditions  
C.17  Copper 
Sulphate  (2) 
Preserved duck 
eggs (2) 
In the alkaline soaking 
solution to assist in the 
preservation process  (2) 
0.0005%, calculated as 
copper, in the edible portion 
of the finished product  
                                                           
1 Tu, Yonggang and Yan Zhao. Inorganic Elements in Preserved Egg. Chapter 40 in Hester, Patricia Y. Egg 
Innovations and Strategies for Improvements . London: Elsevier, 2017.  Notice of Modification to the List of Permitted Food Additives  with Other Accepted Uses  
to Enable the Use of Copper Sulphate  in Preserved Duck Egg s  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    3 Rationale  
 
Health Canada’s F ood Directorate completed  a pre market safety assessment of the requested use 
of copper sulphate . The assessment did not identify any chemical, nutritional, microbiological or  
toxicological food safety concerns with this use of this additive . Therefore, Health Canada has 
enabled th e requested use of copper sulphate  by modifying the List of Permitted Food Additives  
with Other Accepted Us es as shown in the above table.  
 
Other Relevant Information  
 
The Food and Drug Regulations  require that food additives such as  copper sulphate  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 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  October 6, 2017, the day it was published in the  List of 
Permitted Food Additives  with Other Accepted Uses . 
 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 copper sulphate .  Anyone wishing to submit new 
scientific information on the use of this additive or to submit an y inquiries may do so in writing, 
by regular mail or electronically.   If you wish to contact the Food Directorate electronically, 
please use the words " copper sulphate " 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