G/TBT/N/CAN/569  
 
30 October 2018  
(18-6799) 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 Authority and Enquiry Point  
Global Affairs Canada  
Technical Barriers and Regulations Division  
111 Sussex Drive, Ottawa, ON K1A 0G2  
Canada  
Telephone: (343)203 -4273 
Fax: (613)943 -0346 
E-mail: enquirypoint@international.gc.ca  
3. Notified under Article 2.9.2 [ X], 2.10.1 [   ], 5.6.2 [ X], 5.7.1 [   ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. IC S numbers may be provided in addition, where applicable): Sperm 
and ova for assisted human reproduction  
5. Title, number of pages and language(s) of the notified document: (1) Proposed 
regulations entitled Safety of Sperm and Ova Regulations (47 pages, available in English 
and French) (2) Proposed Technical Directive entitled Technical Requirements for 
Conducting the Suitability Assessment of Sperm and Ova Donors (14 pages, available in 
English and French) Note: The proposed Technical Directive is incorp orated by reference 
into the proposed Safety of Sperm and Ova Regulations.    
6. Description of content: The proposed Safety of Sperm and Ova Regulations  would 
establish a human health and safety framework for donor sperm and ova for assisted human 
reprodu ction. Specifically, the  proposed regulations would:  
• Establish minimum requirements for screening and testing sperm and ova donors;  
• Establish a risk -based registration and notification oversight scheme for 
establishments who process, import and distribute  donor sperm and ova;  
• Establish a traceability system whereby donor sperm and ova are identified, labelled 
and stored so that appropriate steps may be taken in the event of an error, accident 
or adverse reaction; and  
Establish a quality management system to ensure that establishments who conduct their 
activities do so in a manner that prevents contamination or cross -contamination, prevents 
the transmission of an infectious disease and maintains the quality of the sperm and ova.  G/TBT/N/CAN/569  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable: There is a need to strengthen the federal regulatory framework governing the 
safety of donor sperm and ova used for the purposes of assisted human reproduction in 
Canada. Th e proposed regulations would address regulatory gaps by: (a) modernizing the 
outdated regulations for donor semen which were made under the Food and Drugs Act  in 
1996; and (b) introducing new regulations for donor ova, which are currently unregulated 
in Canada.  
8. Relevant documents:   
(1) Canada Gazette , Part I, 27 October 2018, pages 3696 -3734 (in English and 
French)  
(2) Technical Requirements for Conducting the Suitability Assessment of Sperm and 
Ova Donors  (in English and French)  
Additional information  on the proposal is available from the following web sites, in English 
and French:  
Backgrounder:  
https://www.canada.ca /en/health -canada/news/2018/10/backgrounder -directed -
donation -process -for-sperm -and-ova-donors.html  
https://www.canada.ca/fr/sante -canada/nouvelles/2018/10/document -dinformation -
processus -de-don-dirige -pour-les-donneurs -de-sperme -et-dovules.html  
Guidance Document:  
https://www.canada.ca/en/health -canada/programs/consultation -assisted -human -
reproduction -regulations/document.html  
https://www.canada.ca/fr/sante -canada/programmes/consultation -reglement -
procreation -assistee/document.html   
9. Proposed date of adoption:  On th e date the regulations are registered, Notification of 
registration would occur through publication in Canada Gazette, Part II, which is 
anticipated to be in Spring 2019.  
Proposed date of entry into force:  The proposed Safety of Sperm and Ova Regulations 
would come into force six months after the publication of the regulations in the Canada 
Gazette, Part II, with a few exceptions for certain provisions.  This period is proposed to 
provide industry with time needed to update their practices to come into com pliance with 
the regulations.  At the same time, an Order in Council would bring into force the related 
prohibitions under section 10 of the Assisted Human Reproduction Act. It is proposed that 
the remaining provisions of the regulations come into force tw elve months after 
publication, to provide time for primary establishments to be provided with and 
communicate their registration numbers.  
The requirements set out in the proposed Technical Directive would take effect six months 
following the publication o f the regulations in Canada Gazette, Part II.  
10. Final date for comments: 10 January 2019  
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 and the Draft Technical Directive can be 
downloaded at:  
http://gazette.gc.ca/rp -pr/p1/2018/2018 -10-27/html/reg2 -eng.html 
http://gazette.gc.ca/rp -pr/p1/2018/2018 -10-27/html/reg2 -fra.html  
https://www.canada.ca/content/dam/hc -sc/documents/programs/consultation -assisted -
human -reproduction -regulations/technical -directive -eng.pdf  
https://www.canada.ca/content/dam/hc -sc/documents/programs/consultation -assisted -
human -reproduction -regulations/technical -directive -fra.pdf