Health Canada’s Proposal to Remove Ethylene Oxide From the List of Permitted Food Additives with Other Accepted Uses   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     1 
  Health Canada’s Proposal to Remove Ethylene Oxide from 
the List of Permitted Food Additives with Other Accepted 
Uses  
Notice of Proposal  – Lists of Permitted Food Additives  
Reference Number: [ NOP/AVP -0025] 
 
June 1 , 2017   
Health Canada’s Proposal to Remove Ethylene Oxide From the List of Permitted Food Additives with Other Accepted Uses   
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  (FDR) .  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 MAs and published on Health Canada’s website.  The food 
additive provisions in the FDR  and the MAs are regulations that Health Canada’s Food 
Directorate administers under the authority of the Food and Drugs Act  (FDA).  
 
A food additive provision for the use of ethylene oxide as a fumigant on whole or ground spices was established under the authority of the FDA on October 5, 1971.  Subsequently, in 1976, the use of ethylene oxide was registered under the authority of the Pest Control Products  Act 
(PCPA ) for restricted use to sterilize and fumigate spices.  Despite the existence of the food 
additive provision for ethylene oxide, Health Canada considers that the regulation of fumigants is appropriately placed under the authority of the PCPA .  Ethylene oxide meets the regulatory 
definition of a pest control product under the PCPA when used for the purpose of fumigation.  The food additive provision and the conditions of registration as a pesticide have historically been complementary . However, a re -evaluation of the safety of ethylene oxide that was 
concluded by the Pest Management Regulatory Agency (PMRA) and a subsequent consultation led to the implementation, in 2013, of changes to the instructions of use for ethylene oxide as a registered pesticide and highlighted the need to remove the food additive provision for ethylene 
oxide, which currently appears in the List of Permitted Food Additives with O ther Accepted Uses
 
on Health Canada’s website.  
 Since the PCPA is the appropriate Act for managing the use of ethylene oxide as a fumigant, Health Canada intends to modify the List of Permitted Food Additives with Other Accepted Uses
 
by removing the entry for ethylene oxide from the List.  
 
Proposed 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  
E.2 Ethylene Oxide  [Removed, YYYY -MM-DD, (See NOM/ADM -XXXX)]  
 
  
Rationale  
 
Currently, the use of ethylene oxide as a fumigant on spices is enabled under  two pieces of 
legislation, the FDA and PCPA.  Under the FDA, there is a food additive provision that permits the use of ethylene oxide at levels consistent with Good Manufacturing Practice on “whole or ground spice (except mixtures containing salt)” provi ded that residues of ethylene chlorohydrin,   
Health Canada’s Proposal to Remove Ethylene Oxide From the List of Permitted Food Additives with Other Accepted Uses   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 a reaction by -product, do not exceed 1500 parts per million (ppm). Ethylene oxide is also 
currently registered under the PCPA as a fumigant for use on similar foods, namely on “whole or 
ground spices and other processed natural seasonings (except mixtures t o which salt has been 
added)”, with the exception of basil, at a maximum application rate of 500  mg active 
ingredient/L chamber volume (500 ppm ethylene oxide).1 
 Health Canada considers that the use of ethylene oxide as a fumigant meets the regulatory definition of a pest control product and therefore is appropriately regulated under the PCPA.  
Removal of the food additive provision for ethylene oxide will mean that the approved 
conditions of use of ethylene oxide will reside solely under the PCPA. 
 Theref ore, Health Canada intends to remove the food additive entry for ethylene oxide, item E.2, 
from the List of Permitted Food Additives with Other Accepted Uses
.  This modif ication to the 
List will result in a single, consistent, appropriate and up- to-date regulatory framework for 
administering the use of ethylene oxide as a fumigant on spices.   
  
Implementation and Enforcement  
 
The proposed change will be effective the day on which it is published in the List of Permitted 
Food Additives with Other Accepted Uses .  This will be announced via a Not ice of Modification 
which will be published on Health Canada’s Website . 
 
The Canadian Food Inspection Agency is responsible for the enforcement of the food- related 
aspects of the FDA  and its associated regulations.  The PCPA is administered by the PMRA.    
 
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 Pasture, PL: 2202C  
Ottawa, Ontario K1A 0L2  
E-mail: bcs -bipc@hc -sc.gc.ca  
 If communicating by e -mail, please use the words “ethylene oxide” in the subject line of your e -
mail. The comment period for this proposal is open until August 15, 2017, 75 days from the date of this posting. 
                                              
1 In 2013, as a result of the PMRA’s re- evaluation of ethylene oxide, basil may no longer be treated with ethylene 
oxide, as per the conditions of registration.  Also, the maximum application rate was reduced, from 1500 to 500 mg 
active ingredient/L chamber  volume.  See: “Re- evaluation Decision RVD2013 -02, Ethylene Oxide” 19 December 
2013.  Available at: http://www.hc -sc.gc.ca/cps -spc/alt_formats/pdf/pubs/pest/decisions/rvd2013- 02/rvd2013- 02-
eng.pdf