G/TBT/N/CAN/569/Add.1  
 
27 June 2019  
(19-4332) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English/French  
 
  
NOTIFICATION  
Addendum  
The following communication, dated 27 June 2019, is being circulated at the request of the 
delegation of Canada .  
 
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Safety of Sperm and Ova Regulations  
The proposed regulations notified in G/TBT/N/CAN/569 (dated 30 October 2018) were adopted and 
published on 26 June 2019 as the Safety of Sperm and Ova Regulations (SOR/2019 -192).  
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. The regulations address 
regulatory gaps by introducing new regulations that: (a) modernize the oversight of donor sperm, 
currently regulated under the outdated Processing and Distribution of Semen for Assisted Conception 
Regulations  which were made under the Food and Drugs Act  in 1996; and (b) add regulatory 
oversight for donor ova, which are currently unregulated in Canada. The regulations support the 
bringing in to force of section 10 of the Assisted Human Reproduction Act , which prohibits the 
distribution, use or importation of donor sperm or ova for the purpose of assisted human 
reproduction unless it complies with regulations.  
The regulations establish a human health and safety framework for donor sperm and ova for assisted 
human reproduction. Specifically, the regulations:  
• Establish minimum requirements for screening and testing sperm and ova donors;  
• Establish a risk -based registration and notification oversigh t scheme for establishments 
who process, import and distribute donor sperm and ova;  
• Establish quality management requirements to ensure that establishments who conduct 
their activities do so in a manner that reduces the risks to human health and safety an d 
the safety of sperm or ova. These include, among others, traceability requirements 
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.  
The donor sc reening and testing requirements are set out in a technical document entitled Technical 
Requirements for Conducting the Suitability Assessment of Sperm and Ova Donors that is 
incorporated by reference into the regulations.  
With the exception of one provis ion, the regulations will come into force on 4 February 2020, on the 
same day as section 10 of the Assisted Human Reproduction Act comes into force. The Processing 
and Distribution of Semen for Assisted Conception Regulations  will also be repealed on that day. 
Section 3 of the regulations will come into force on 2 August 2020.  
The full text of the measure can be downloaded from the Internet addresses below:  
(1)  Safety of Sperm and Ova Regulations  
http://gazette.gc.ca/rp -pr/p2/2019/2019 -06-26/html/sor -dors192 -eng.html  
http://gazette.gc.ca/rp -pr/p2/2019/2019 -06-26/html/sor -dors192 -fra.html  
(2)  Techn ical Requirements for Conducting the Suitability Assessment of Sperm and Ova Donors  
https://www.canada.ca/en/health -canada/services/publications/drugs -health -products/technical -G/TBT/N/CAN/569/Add.1  
 
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  directive -sperm -ova-donors.html   
https://www.canada.ca/fr/sante -canada/services/publications/medicaments -et-produits -
sante/directive -technique -donneur -spermatozoides -ovules.html  
or requested from:  
Canada's Notification Authority and Enquiry Po int 
Global Affairs Canada  
Technical Barriers and Regulations Division  
111 Sussex Drive  
Ottawa, ON K1A 0G2  
Canada  
Telephone: (343) 203 -4273 
Fax: (613) 943 -0346 
Email: enquirypoint@international.gc.ca  
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