G/TBT/N/CAN/621/Add.1  
 
20 April 2021  
(21-3362) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English /French  
 
 
NOTIFICATION  
Addendum  
The following communication , dated  20 April 2021 , is being circulated at the request of the 
delegation of Canada . 
 
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Title: Regulations Amending the Food and Drug Regulations (Human Milk Fortifiers)  
 
Reason for Addendum:  
[  ] Comment period changed - date:   
[X] Notified measure adopted - date: 29 March 2021  
[X] Notified measure published - date: 14 April 2021  
[X] Notified measure enters into force - date: The regulatory amendments will come into 
force on 14 April 2021. Manufacturers of Human Milk Fortifiers (HMFs) which are 
currently marketed in Canada will have a period of one year after this date to be notified 
by the Minister of Health that they are authorized to sell and advertise for sale the HMF, 
plus an additional year (2 years total) to come into compliance with the new labelling 
regulations.  
[X] Text of final measure available from1:  
https://canadagazette.gc.ca/rp -pr/p2/2021/2021 -04-14/html/sor -dors57 -eng.html  
https://canadagazette.gc.ca/rp -pr/p2/2021/2021 -04-14/html/sor -dors57 -fra.html  
https://gazette.gc.ca/rp -pr/p2/2021/2021 -04-14/pdf/g2 -15508.pdf#page=50  
[  ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:   
[  ] Content or scope of notified measure changed  and text available from1:  
New deadline for comments (if applicable):   
[  ] Interpretive guidance issued and text available from1:  
[  ] Other:  
 
Description:  The proposed regulations notified in G/TBT/N/CAN/621 (dated 16 October 2020) were 
amended, adopted and were published on 14 April 2021 as the Regulations Amending the Food and 
Drug Regulations (Human Milk Fortifiers).  
The regulations amend the Food and Dr ug Regulations  (FDR) to establish a regulatory framework 
for the sale of HMFs in Canada. HMFs are infant foods with added vitamins, minerals or amino acids 
which are intended to be added to human milk (i.e. breast milk) to increase its nutritional value an d 
provide necessary nutrients for infants who are born prematurely or for other infants as medically 
 
1 This information can be provided by including a website address, a pdf attachment, or other 
information on where the text of the final /modified  measure and/or interpretive guidance can be obtained.  G/TBT/N/CAN/621/Add.1  
 
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  required (e.g. small for gestational age, high protein needs). There were previously no provisions in 
the FDR specific to these products, meaning the gener al food framework applied. The amendments 
to the FDR set out regulatory requirements specific to these products to safeguard the health and 
safety of vulnerable infants who need HMFs to meet their nutritional requirements.  
The regulations establish a pre -market assessment scheme for HMFs and HMFs that have undergone 
a major change; set conditions of sale, including stopping sale if evidence shows the HMF product is 
no longer safe or nutritionally adequate;  permit the addition of vitamins, m ineral nutrients, and 
other key ingredients to HMFs; and set out labelling requirements. The establishment of clear 
regulatory requirements will help ensure continued access to safe and nutritionally adequate HMFs 
for certain vulnerable infant populations in Canada, and provide greater clarity to manufacturers and 
importers wishing to sell or advertise for sale these products in Canada.  
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