G/TBT/N/CAN/648  
30 June 2021  
(21-5233) Page: 1/3 
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  
Technical Barriers and Regulations Division  
Global Affairs Canada  
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 [X], 2.10.1 [   ], 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):  Natural 
health products; Pharmaceutics (ICS 11.120)  
5. Title, number of pages and language(s) of the notified document:  Regulations 
amending the Natural Health Products Regulations (60 pages, available in English and 
French)  
6. Description o f content:  Health Canada is proposing to amend the Natural Health 
Products Regulations (NHPR) to introduce the following four labelling requirements:  
1) A Product Facts Table:  Important information already required by the NHPR on the 
label of a natural he alth product (NHP) in a non -standardized format would be required 
in a standardized Product Facts table. Certain lower -risk NHPs would be exempt from the 
Product Facts table requirement, and flexibilities would be provided for products with 
packages too sm all to accommodate a full facts table.    
2) Labelling of food allergens, gluten and aspartame : Products containing a priority food 
allergen, gluten, or aspartame would require a statement indicating such in a consistent 
manner within the Product Facts table, or elsewhere on the label if the product is exempt 
from the facts table.  
3) Clearly and prominently displayed label text:  Text on the label, including within the 
Product Facts table, would be subject to improved legibility requirements, including a 
minimum type size, standardized font types, and colour contrast requirements. This would 
ensure consumers could locate, read and compare important safety information.   G/TBT/N/CAN/648  
 
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  4) Modernized contact information:  A manufacturer or importer could display an e -mail 
address, telephone number, or website address within an NHP's Product Facts table (or 
elsewhere on the label if the NHP is exempt from the facts table requirement) instead of 
a postal address, as is currently required.  
In addition, Health Canada would take  this opportunity to bring forward certain 
amendments to the NHPR for clarification only. These would neither set out new 
requirements nor remove existing requirements and are expected to be cost neutral to 
both government and regulated parties.  
7. Object ive and rationale, including the nature of urgent problems where 
applicable:  NHP use among Canadians has been increasing, and is expected to increase 
further due to a number of factors, such as Canada's aging population, the COVID -19 
pandemic, greater acce ss to the Internet and other sources of information on self -care 
products, and an increase in consumers' role in their own self -care. When key information 
on NHP labels is not presented in a clear, consistent, and legible format, it makes it 
difficult for consumers and health professionals to locate, read, and compare important 
safety information. Poor communication of key information on health product labels can 
lead to incorrect purchases and preventable harms. These preventable harms and delays 
in effect ive treatments due to incorrect purchases or use, negatively impact the health 
and safety of Canadians, add burden to the health care system, and impact the Canadian 
economy through lost productivity. The objectives of this regulatory proposal are to:  
1. Improve the self -selection and safe use of NHPs by supporting informed choice 
and making labels easier to read with clear, accurate, and accessible 
information that is presented in a consistent format;  
2. Protect the health and safety of Canadians by reducing th e number of 
preventable harms associated with NHP use; and,  
3. Introduce amendments to clarify existing provisions of the NHPR.  
; Consumer information, labelling; Protection of human health or safety  
8. Relevant documents:   
Canada Gazette , Part I, 26 June 2021, pages 3388 -3448 (available in English and French)  
https://gazette.gc.ca/rp -pr/p1/2021/2021 -06-26/pdf/g1 -15526.pdf#page=240  
Guidance document on Labelling:  
https://www.canada.ca/en/health -canada/programs/consultation -improved -labelling -
natural -health -products -proposed -changes -regulations.html  (English)  
https://ww w.canada.ca/fr/sante -canada/programmes/consultation -amelioration -
letiquetage -produits -sante -naturels -modifications -proposees -
reglementation.html  (French)  
9. Proposed date of adoption:  Not determined  
Proposed date of entry into force:  The proposed regulations would come into force 3 
years following registration. The sale of NHPs that were being sold in Canada prior to the 
coming into force would be provided an additional 3 years to continue being sold without 
complying with the new labe lling requirements (a total of 6 years for existing products to 
come into compliance).  
10. Final date for comments:  4 September 2021  G/TBT/N/CAN/648  
 
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  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 regulatory text can be found at:  
https://gazette.gc.ca/rp -pr/p1/2021/2021 -06-26/html/reg4 -eng.html  
https://gazette.gc.ca/rp -pr/p1/2021/2021 -06-26/html/reg4 -fra.html