Policy for the Management of Industrial Hemp Varieties on the List of Approved Cultivars

The Industrial Hemp Regulations (IHR 1998) under the Controlled Drugs and Substances Act (CDSA), were repealed on October 17, 2018. New Industrial Hemp Regulations (IHR) which came into force in 2018 under the Cannabis Act set out the requirements for various activities with industrial hemp, such as cultivation, import, export, and sale.

The IHR set out the regulatory framework for controlling and authorizing certain activities with industrial hemp, which is defined under the IHR as a cannabis plant, or any part of that plant, in which the concentration of delta-9-tetrahydrocannabinol (THC) is 0.3% weight by weight or less in the flowering heads and leaves. Those who hold a licence under the IHR may be authorized to cultivate these plants, but must grow from pedigreed seed of industrial hemp varieties approved for commercial cultivation (i.e. those listed on the List of Approved Cultivars (LOAC)). An exception is made for plant breeders. The IHR requires that the holder of a licence that authorizes cultivation for seed test for THC, for the purpose of determining the concentration of THC in the flowering heads and leaves.

While the new IHR are generally consistent with the former IHR, some changes were made to align licence requirements to the relatively low risk posed by industrial hemp as compared with other varieties of cannabis. One of the changes may permit the sale of industrial hemp plants (flowers, leaves and branches) to licence holders under the IHR or the Cannabis Regulations, for example, to licensed cannabis processors to provide a source of phytocannabinoids, such as cannabidiol (CBD).

The Cannabis Act does not apply to anything referred to in Schedule 2 of the Act, including non-viable seeds or mature stalk without any leaf, flower, seed or branch. As such, activities related to the plant parts included in Schedule 2 (such as their processing or sale) do not require a licence under the Act and are not subject to the IHR.

Members of the Interdepartmental Working Group on Industrial Hemp Cultivars (Working Group), which includes representatives from the Canadian Food Inspection Agency (CFIA), Agriculture and Agri-Food Canada (AAFC), and the Canadian Seed Growers’ Association (CSGA), work together to make recommendations to Health Canada regarding the industrial hemp varieties that should be considered for addition to the LOAC, as well as those that should be placed under observation or removed from the list due to a potential to exhibit more than 0.3% THC (w/w).

3. Definitions

For the purposes of this policy, the following terms will be understood to have the same meaning as given in the IHR and are set out below for convenient reference:

"Competent laboratory" means a laboratory that is owned or operated by a holder of a licence for analytical testing issued under subsection 62(1) of the Act, or a laboratory outside Canada that is recognized as a qualified laboratory, for the application of the United Nations' Single Convention on Narcotic Drugs, 1961, as amended from time to time, by the competent authorities of the country in which it is located.

"Approved cultivar" means any variety of industrial hemp set out in the List of Approved Cultivars, published by the Government of Canada on its website, as amended from time to time.

4. Policy

It is the objective of this policy to establish the criteria under which the Minister will add or remove varieties of industrial hemp to or from the LOAC. This policy applies to submissions to Health Canada, including the required supporting documentation and data for the addition of new varieties of industrial hemp to the LOAC, as well as suggestions for the removal of varieties from the list.

5. Process

a) Eligibility Requirements

Adding a New Variety to the LOAC

The Working Group will evaluate submissions for varieties to be included on the LOAC and make recommendations to Health Canada for the addition of those varieties to the list, if the following criteria are fulfilled:

True variety: The variety must be recognized as a true variety by the responsible authorities of a member country participating in the 'Crucifer Seed and Other Oil and Fibre Species' Scheme of the Organization for Economic Cooperation and Development (OECD) Seed Schemes', a member of the Association of Official Seed Certifying Agencies (AOSCA), or the CSGA.
Sufficient evidence: Sufficient evidence must be provided by the plant breeder, or the applicant for addition of the variety, to demonstrate that the variety will consistently produce industrial hemp, that is, a cannabis plant containing 0.3% THC (w/w) or less. The data must be obtained from a minimum of three statistically sound and well-designed experimental trials in Canada, either indoors, outdoors, and/or in greenhouses. When applicable, the evidence package should discuss how the experimental design/conditions may, for example, account for plants grown in different environmental conditions from those where the plants are intended to be grown for production (e.g. how lighting conditions used to generate greenhouse or indoor data are relevant to outdoor production). Health Canada and the Working Group will determine whether the evidence is sufficient and satisfactory. The experimental protocol must also be submitted.
Testing: Analytical testing on the proposed variety must be conducted by a competent laboratory as defined in the IHR (subsection 1(1)). Testing must be conducted using validated methods on a representative sample of the flowering heads and leaves (see sampling section below). Determination of THC concentration must take into account the potential to convert delta-9-tetrahydrocannabinolic acid (THCA) into THC. Analytical data provided for the THC content is to be reported on a dry weight basis. The laboratory and method used to perform this testing must be clearly identified and contain sufficient details as to enable evaluation. For example, the description of the method should clearly speak to its quantitative range, including limit of quantification (LOQ).
Sampling: Sampling is done in a manner that will provide an appropriate analytical specimen that demonstrates the variety will consistently produce industrial hemp, that is, a cannabis plant containing 0.3% THC (w/w) or less in the flowering heads and leaves. Sampling must be conducted by a provincially designated professional or technical agrologist (or equivalent for those provinces having no such designation process), with experience in crop production and sampling, or by a pedigreed-seed crop inspector recognized by the CSGA. The applicant must submit their sampling and sample preparation protocol with their evidence package.

The minimum requirements for sampling are as follows:
1. Minimum of 30 specimens for testing, and 30 specimens which must be retained as set-aside specimens.
2. The sample should be representative. The part of the plant being sampled is the entire fruit bearing part of the plant (female inflorescence), taken from the top third of the plant. Samples should be taken arbitrarily at different parts of the stand.
3. For cultivars intended to be harvested by cultivators with seeds present, sampling shall commence as the seed begins to mature, i.e. when the first seeds of 50% of the plants are resistant to compression. For cultivars that are intended to be harvested by cultivators with no seeds present (i.e. female flowers are kept unpollinated or harvested prior to seed production to be used, for example, by a licensed processor to produce cannabis), the sampling shall occur during the period at which THCA content is expected to be at its highest.
4. Test samples should be dried to 8 - 13 % moisture content and have seeds and stems removed prior to testing. Samples should be stored in darkness at a temperature not more than 20 degrees Celsius.
Variety Certification Eligibility: The applicant must submit a copy of the variety's "CSGA Variety Certification Eligibility Application" form submitted to CSGA, or all of the information contained therein.

Placing a Variety Under Observation or Removing a Variety from the LOAC

When the Working Group becomes aware that a variety may no longer meet the THC criteria outlined above, or if questions arise surrounding the information provided to meet criteria i. to v., the Working Group may undertake a review. If one or more of the criteria are not met, the Working Group will make recommendations to Health Canada on whether to place a variety under observation or to remove it.

b) Information to be Submitted to the LOAC Working Group

In addition to the documents and information specifically listed above, submissions must include all available information in your possession regarding lineage and THC results.

c) Timing

Proposals for the addition of new cultivars on the LOAC or removal will be evaluated by the Working Group and Health Canada twice yearly, subject to submission deadlines set by Health Canada.

d) General

Varieties that are to be removed from the list will be identified as such and will appear on the LOAC for a one year grace period to permit existing seed stocks to be cleared from the system. Grain and fibre produced during the grace period and in previous years from varieties that are removed from the list will be permitted to be sold for processing and consumption after removal of the variety from the LOAC, provided THC concentrations are 0.3% (w/w) or less.

6. Submissions and Enquiries

Submissions and enquiries related to this policy should be directed to Health Canada, at:

hc.hemp-chanvre.sc@canada.ca

7. References

a) Pertinent References

b) Other Information Sources

Information is available on the Health Canada website at: Producing and selling hemp

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Date modified:: 2020-03-11

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