  
  
G/TBT/N/CAN/672  
13 May 2022  
(22-3755) 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  
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: enquirypoint@international.gc.ca  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
Sterilization and disinfection (ICS: 11.080), Chemicals for industrial and domestic 
disinfection purposes (ICS: 71.100.35)  
5. Title, number of pages and language(s) of the notified document:  Biocides 
Regulations; (100 page(s), in English and French)  
6. Description of content:  Products that sanitize or disinfect hard or soft non -living 
surfaces to prevent disease in humans or animals (collectively referred  to as biocides) are 
currently subject to different requirements, despite having similar risks, benefits, uses 
and ingredients. Health Canada is proposing a new set of regulations under the Food and 
Drugs Act  (FDA) specific to biocides, that would see:  
• the transfer of disinfectants that are currently regulated under the Food and Drug 
Regulations  (FDR) and surface sanitizers regulated under the Pest Control 
Products Act  (PCPA) that meet the definition of a drug, to the proposed Biocides 
Regulations ; 
• the crea tion of a modern authorization and regulatory framework with safety, 
efficacy and quality regulatory requirements better suited to biocides;  G/TBT/N/CAN/672  
 
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  • the maintenance of a life -cycle approach to the regulation of biocides while 
supporting requirements and authoritie s for the continuous post -market 
monitoring of a biocide's risks and benefits; and  
• the creation of a pathway for authorization based on decisions from foreign 
regulatory authorities.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The objective of this proposal is to introduce a new, modern regulatory 
framework under the FDA that is specific to the authorization and lifecycle management 
of biocides. Tailored application and regulatory requirements for thes e products would 
facilitate greater international harmonization, reduce administrative burden, provide 
stronger post -market oversight, and provide Canadians with more timely access to 
biocides.  
8. Relevant documents:   
Canada Gazette , Part I, 7 May 2022, pages 2081 -2180 https://www.gazette.gc.ca/rp -
pr/p1/2022/2022 -05-07/pdf/g1 -15619.pdf  (available in English and French)  
Proposed Guidance Document:  
https://www.canada.ca/en/health -canada/programs/consultation -proposed -biocides -
regulations.html  (English)  
https://www.canada.ca/fr/sante -canada/programmes/consultation -projet -reglement -
biocides.html  (French)  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  The proposed Biocide Regulations would come into 
force one year after they are registered. At this point, all new products entering the 
market would have to meet the proposed requirements. Those who hold a registration for 
a surface sanitizer under the PCP A or an authorization for a disinfectant under the FDR 
would have a transition period of four years from the coming into force date to obtain an 
authorization under the proposed Biocides Regulations by using an abbreviated 
application. As registrations for  surface sanitizers under the PCPA are renewed every five 
years, registrants would be able to file an abbreviated application under the proposed 
Biocides Regulations as their product registrations are set to expire.  
10. Final date for comments:  16 July 20 22 
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/p1/2022/2022 -05-07/html/reg2 -eng.html  (English) 
https://gazette.gc.ca/rp -pr/p1/2022/2022 -05-07/html/reg2 -fra.html  (French)  
 