Changes have been made to how biological agents will be processed upon import into Canada. Whether you’re an importer that is unsure about the classification of your goods, or someone that imports biological agents regularly, it’s essential that you stay informed on these kinds of updates in order to avoid mistakes and noncompliance.

Who is the administrative and enforcing body at the Government of Canada? 

The Public Health Agency of Canada or PHAC. They are the government agency that is responsible for the “administration and enforcement of the Human Pathogens & Toxins Act (or HPTA), the Human Pathogens & Toxins Regulations (A.K.A. HPTR), and the administration of specific sections within the regulations for the Health of Animals (HAR).  

biological import licencing

They essentially are responsible for: 

“establishing a safety and security regime in order to protect the health and safety of the public against risks posed by human pathogens and toxins. PHAC administers and enforces the HPTA through the Centre for Biosecurity (CB). 

 PHAC is also responsible for the administration of certain provisions of the Health of Animals Act and Health of Animals Regulations (HAA/HAR). It issues import permits and transfer authorizations for most terrestrial animal pathogens.”

What are the updated requirements for importing biological agents into Canada?

Activities, such as importing human pathogens are classified by the Centre for Biosecurity (CB) as Risk Group 2-4, with toxins listed in Schedule 1 of HPTA. These imports require a licence, as issued by the Public Health Agency of Canada. In addition to imports of that nature, PHAC also issues permits for the importation of pure cultures of terrestrial animal pathogens and toxins.

CB recently completed a risk assessment that updated the Risk Group for various biological agents into Risk Group 2. 

Which biological agents are impacted? 

  • Regulated under the Human Pathogens and Toxins Act:
  • Suid alphaherpesvirus 1 is now RG 2 for humans and RG 3 for animals.
  • Candida auris is now RG 2 for humans and RG 1 for animals.
  • Klebsiella oxytoca is now RG 2 for humans and RG 2 for animals.
  • Fusarium solani is now RG 2 for humans and RG 1 for animals.

You must now have the appropriate licence under HPTA if you are importing these pathogens. These changes to Risk Group are under immediate effect, as reflected in the ePATHogen database. 

What is the ePATHogen database? 

The ePATHogen database is a Public Health Agency of Canada-owned search engine for classification and risk groups for various pathogens and biological agents. It is updated on a weekly basis with new information and classifications. You can access it at: 


Staying informed in cases where you are handling the importation of goods of biological or pathogenic nature is your best bet for avoiding issues upon entry into Canada. These types of customs transactions are heavily monitored for correct classification, licencing, and other measures related to compliance.

To ask further questions on how to move biological agents or pathogens into Canada in a safe and efficient manner, please contact a customs broker. You may start a 0-commitment conversation right here!