G/TBT/N/CAN/621  
16 October 2020  
(20-7141) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English, French  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  CANADA   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Department of Health  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
Canada's Notification Auth ority and Enquiry Point  
Global Affairs Canada  
Technical Barriers and Regulations Division  
111 Sussex Drive  
Ottawa (Ontario) K1A 0G2  
Canada  
Telephone: (343)203 -4273 
Fax: (613)943 -0346 
Email: enquirypo int@international.gc.ca   
3. Notified under Article 2.9.2 [   ], 2.10.1 [X], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Human 
milk fortifiers; Prepackaged and prepared foods (ICS 67.230)  
5. Title, number of pages and language(s) of the notified document:  Regulations 
Amending the Food and Drug Regulations (Human Milk Fortifiers) (12 pages, available in 
English and in French)  
6. Description of content:  The proposed regulations would amend the Food and Drug 
Regulations  (FDR) to establish a regulatory framework for the sale of human milk fortifiers 
(HMFs) in Canada. HMFs are foods which are intended to be added to  human milk to 
increase its nutritional value in order to meet the particular requirements of an infant in 
whom a physiological condition exists as a result of a disease, disorder or abnormal 
physical state. There are currently no provisions in the FDR spe cific to these products, 
meaning the general food framework applies. Amendments to the FDR are needed to 
permit HMFs to have added vitamins, mineral nutrients, and amino acids, and to include 
provisions to safeguard the health and safety of the vulnerable population using HMFs.  
The proposed amendments would establish a premarket submission requirement for HMFs 
new to the market and HMFs that have undergone a major change; permit the addition 
of vitamins, mineral nutrients, and amino acids to HMFs; set out l abelling requirements; 
and set out conditions of sale. The establishment of clear regulatory requirements would 
help to ensure continued access to safe and nutritionally adequate HMFs for certain 
vulnerable infant populations in Canada, enable their use ou tside of hospitals under 
medical supervision, and provide greater clarity to manufacturers and importers wishing 
to sell or advertise for sale these products in Canada.  G/TBT/N/CAN/621  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  The objectives of the proposed amendments to the FDR are to help ensure 
the health and safety of the infant population that rely on HMFs by establishing a 
regulatory pathway for the sale of these products in Canada. Due to the vulnerability of 
the infant population that requires these products and given that the proposed regulations 
are trade facilitating measures, this notification is issued under Article 2.10.1 to expedite 
the coming into force of these regulations.; Protection of human health  or safety  
8. Relevant documents:   
• Draft Regulations Amending the Food and Drug Regulations (Human Milk 
Fortifiers): Policy Paper – Fall 2020 (11 and 12 pages, available in English and 
French)  
9. Proposed date of adoption:  On the day of their publication in the Canada Gazette, Part 
II. 
Proposed date of entry into force:  These Regulations come into force on the day of 
their publication in the Canada Gazette, Part II. HMFs which are currently marketed in 
Canada would have a period of 1 year after  this date to come into compliance with the 
new regulations.  
10. Final date for comments:  15 November 2020  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
The electronic version of the regulations can be downloaded at:  
Canada's Notification Authority and Enquiry Point  
Global Affairs Canada  
Technical Barriers and Regulations Division  
111 Sussex Drive  
Ottawa (Ontario) K1A 0G2  
Canada  
Telephon e: (343)203 -4273 
Fax: (613)943 -0346 
Email: enquirypoint@international.gc.ca  
https://members.wto.org/crnattachments/ 2020/TBT/CAN/20_6165_00_e.pdf  
https://members.wto.org/crnattachments/2020/TBT/CAN/20_6165_00_f.pdf  
https://members.wto.org/crnattachments/2020/TBT/CAN/20_6165_01_e.pdf