Canada Cannabis Testing Regulations

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Note: With this guide in general, and this chapter in particular, it should be noted that LabLynx isn't providing legal advice. Regulations change constantly, and it's ultimately up to the laboratory to be responsible for verifying legal requirements for compliance.


In the fall of 2018, Canada legalized the purchase, growth, and consumption of marijuana in small amounts across the country.[1] With it came more organized regulations concerning how laboratories handled licensing, testing, data management, and various other aspects of operating a cannabis testing laboratory.

Canada's cannabis testing regulations

1. Laboratory licensing requirements

Laboratories interested in becoming licensed in Canada to analytically test cannabis should use Health Canada’s Cannabis Tracking and Licensing System (CTLS) as the primary means of submitting a licensing application. For cannabis testing laboratories, a user account is required for several associated individuals. This includes a director/officer/partner (depending on how the business is set up), a license holder, and head of laboratory. A security clearance application by the director/officer/partner will also be required before the licensing application can be submitted. Afterwards, a corporate profile must be built on CTLS with proposed license holder, mailing address, site details, site personnel, physical security, and record keeping details. The application guide should be followed for this process.[2]

2. Basic sampling requirements

A representative sample of a lot or batch must be taken. The document Mandatory Cannabis Testing for Pesticide Active Ingredients - Requirements, published in late 2018, elaborates that a sample may also be considered representative if it is taken from lot/batch packaging and labeling. Additionally, a sample of the plants from which seeds and cuttings came may also qualify as representative.[3]

3. COC requirements

The Cannabis Regulations of 2018 make no mention of chain of custody (COC). However, standards like ISO/IEC 17025 are still required by accreditation bodies that manage the quality management criteria for clinical and other laboratories in the Canadian provinces.[4]

4. Harvest batch sampling requirements

No granular sampling requirements are described in the Cannabis Regulations of 2018.

5. Cannabis product and pre-roll batch sampling requirements

No granular sampling requirements are described in the Cannabis Regulations of 2018.

6. Transportation requirements for cannabis goods

Distribution methods must maintain the quality of cannabis goods so as to not degrade them or render them useless.[5]

7. Sample reception requirements

Storage locations must be surrounded by a physical barrier preventing unauthorized access, and access must be restricted to individuals who are required to be in the area due to their duties. Storage conditions must be maintained to ensure samples and lots can maintain their quality and remain uncontaminated in a sanitary environment. The storage environment should also have adequate air filtration to prevent the escape of odors. Test equipment must be equally sanitary and maintained to prevent contamination of samples.[5]

8. SOP requirements

The government simply states that tested cannabis must be done so using standard operating procedures (SOPs) “designed to ensure [testing is] conducted in accordance” with the law.[5] The document Mandatory Cannabis Testing for Pesticide Active Ingredients - Requirements, published in late 2018, elaborates: “License holders must prepare and approve sampling procedures specific to each type of product to be tested. The sampling procedures may be verified during inspections.”[3] SOPs should also elaborate procedures for cleaning test and storage spaces and instruments, as well as ensuring practices that provide for sanitary handling of samples.[5]

9. Test method base requirements

Test methods must be specific to fresh cannabis, cannabis plants, dried cannabis, cannabis oil, etc.[3]

10. Test method validation requirements

Test methods must be validated, and any associated limit of quantification (LOQ) must be equal to or lower than those set by the government. (It seems only pesticide ingredient LOQs have been produced so far.) Records documenting validation studies must be maintained and may be asked for during inspection.[3][5] Health Canada provides guidance on validating methods in “Q2B: Validation of Analytical Procedures: Methodology.”[6]

11. Testing requirements

Cannabis testing labs must be independent of any other type of cannabis license holder types requesting sample analysis.[3] Cannabis product cannot be moved on for sale if test validation, sampling, and composition requirements have not been met.[5] Cannabis product must be tested for residual solvents; microbial contaminants; chemical contaminates; pesticides; dissolution/disintegration; and the cannabinoids THC, THCA, CBD, and CBDA.[5][3]

11.1 Residual solvents in cannabis oil

Cannabis oil may contain residual solvents as long as they do not exceed the limits set out by Health Canada's Limits for Residual Solvents in Cannabis Products, as shown below in Table 1[7]:

Table 1. Limits for residual solvents in cannabis products
Solvent Class Limits (parts per million)
Acetic acid Cannabis oil 5000
Acetone Cannabis oil 5000
Anisole Cannabis oil 5000
1-Butanol Cannabis oil 5000
2-Butanol Cannabis oil 5000
Butane (sum of n- and iso-) Cannabis oil 5000
Butyl acetate Cannabis oil 5000
Tert-Butylmethyl ether Cannabis oil 5000
Carbon dioxide Cannabis oil No limit
Dimethyl sulfoxide Cannabis oil 5000
Ethanol Cannabis oil 5000
Ethyl acetate Cannabis oil 5000
Ethyl ether Cannabis oil 5000
Ethyl formate Cannabis oil 5000
Formic acid Cannabis oil 5000
Heptane Cannabis oil 5000
Isobutyl acetate Cannabis oil 5000
Isopropyl acetate Cannabis oil 5000
Methyl acetate Cannabis oil 5000
3-Methyl-1-butanol Cannabis oil 5000
Methylethyl ketone Cannabis oil 5000
2-Methyl-1-propanol Cannabis oil 5000
Nitrogen Cannabis oil No limit
Pentane Cannabis oil 5000
1-Pentanol Cannabis oil 5000
1-Propanol Cannabis oil 5000
2-Propanol Cannabis oil 5000
Propane Cannabis oil 5000
Propyl acetate Cannabis oil 5000
Triethylamine Cannabis oil 5000
Water Cannabis oil No limit

11.2 Microbial and chemical contaminates

Cannabis product may contain microbial and chemical contaminates as long as they do not exceed limits for herbal medicines for human consumption set by any of the following publications[5][8]:

  • European Pharmacopoeia
  • Pharmacopée française
  • Pharmacopoeia Internationalis
  • The British Pharmacopoeia
  • The Canadian Formular
  • The National Formulary
  • The Pharmaceutical Codex: Principles and Practices of Pharmaceuticals
  • The United States Pharmacopoeia

11.3 Pesticides

Per the Mandatory Cannabis Testing for Pesticide Active Ingredients - Requirements document published by Health Canada at the end of 2018, Health Canada set a limit of quantification (LOQ) for pesticide active ingredients in different matrices. The LOQs of nearly 100 different pesticide active ingredients are detailed in their associated List and Limits sub-document, which should be monitored for updates. LOQs are listed in parts per million. The license holder requesting the analysis is responsible for reporting pesticide results to Health Canada. However, the laboratory is still required to hold pesticide test results for two years after the day the COA was created and produce them in a timely fashion upon request during inspection.[3][9]

11.4 Dissolution and Disintegration

Cannabis product intended for oral, rectal, or vaginal administration must meet the requirements for a dissolution or disintegration test applicable to its formulation set by any of the following publications[5][8]:

  • European Pharmacopoeia
  • Pharmacopée française
  • Pharmacopoeia Internationalis
  • The British Pharmacopoeia
  • The Canadian Formular
  • The National Formulary
  • The Pharmaceutical Codex: Principles and Practices of Pharmaceuticals
  • The United States Pharmacopoeia

11.5 Cannabinoid testing

Each discrete unit of a product intended for oral, rectal, or vaginal administration “must not exceed a maximum yield quantity of 10 mg of THC, taking into account the potential to convert THCA into THC.” Cannabis oil “must not exceed a maximum yield quantity of 30 mg of THC per milliliter of the oil, taking into account the potential to convert THCA into THC.” However, accessories that activate cannabis oil must not exceed 10 mg of THC.[5]

12. COA requirements

Per the Mandatory Cannabis Testing for Pesticide Active Ingredients - Requirements document published by Health Canada at the end of 2018, certificates of analysis (COAs) must contain demographics of the entity requesting test analysis, laboratory demographics, test method specifics (method, instruments, validation date), lot/batch identifier, sample date, analysis date, list of what was tested, lab’s LOQ, itemized test results, and an attestation of the results by the laboratory.[3]

13. Remediation and retesting requirements

The Cannabis Regulations of 2018 make no mention of remediation and retesting.

14. Sample retention requirements

Any lot or batch samples, as well as any cannabis obtained from the samples, must be destroyed within 90 days of completing analyses. Additionally, any lot or batch samples not beginning analysis within 120 days upon receipt must be destroyed “within that period.” However, Canada Health also mandates that a portion of the representative sample used for analyses “must be retained for at least one year after the date of the last sale of any portion of the lot or batch” and must be sizeable enough to re-verify if the associate lot/batch meets legal requirements, re-verify cannabinoid percentages, and re-verify that cannabis meets Pest Control Products Act pesticide requirements.[5][3]

15. Laboratory quality assurance (LQA) requirements

The Cannabis Regulations of 2018 make no mention of laboratory quality assurance. However, clinical and other laboratories still must adhere to the explicit quality management requirements of their associated provincial and regional accrediting bodies.[4]

16. Laboratory quality control (LQC) requirements

The Cannabis Regulations of 2018 make no mention of laboratory quality control. However, clinical and other laboratories still must adhere to the explicit quality management requirements of their associated provincial and regional accrediting bodies.[4]

17. LOD and LOQ requirements

Limits of detection (LOD) and limits of quantitation (LOQ) are not explicitly mentioned in the Cannabis Regulations of 2018. However, the late 2018 Mandatory Cannabis Testing for Pesticide Active Ingredients - List and Limits published by Health Canada does list LOQs for pesticides.[9] See 11.3 for more.

18. Data package requirements

The Cannabis Regulations of 2018 make no mention of data package requirements.

19. Proficiency testing requirements

The Cannabis Regulations of 2018 make no mention of proficiency testing requirements. However, clinical and other laboratories still must adhere to the explicit proficiency testing requirements of their associated provincial governments or accrediting bodies. In some provinces, proficiency testing may be voluntary.[4]

20. Audit requirements

Aside from mentioning that required documents and information be made available for a Minister audit at any given time[5], the Cannabis Regulations of 2018 make no mention of audit requirements.

21. Employee requirements

The head of laboratory must have a degree related to the work they will carry out from a Canadian university or recognized by a Canadian university or professional association. They must also demonstrate “sufficient knowledge” of Canada’s cannabis regulations and have knowledge/experience related to the work they will carry out. An alternate head of laboratory can also be designated or replace an existing head of laboratory, but only with Minister’s approval. Said action requires an application with the name and date of birth of the proposed alternate, statement of qualifications, and signed and dated attestation that the information is correct.[2]

22. Record retention requirements

Documents and information retained in relation to cannabis testing activities, etc. must be retained in such a way as to allow audit of it in a timely fashion. Such documents and information must be available for viewing at the site specified in the license. If the license expires, the documents and information must still be held throughout their required retention period, and the Minister must be notified in writing of the address where those documents and information will be retained. Any such notice must also be retained for a period of two years after the day the notice was sent.

Upon receiving cannabis, the laboratory must retain a document that contains the name of who it was received from, to and from addresses, date received, quantity received, description, lot or batch number, form, strength per unit, and intended use. That document must be retained for two years beyond the date it was created. Any cannabis product destroyed by the laboratory must be documented with a description, date destroyed, pre-destruction weight/volume, address of location where destroyed, method of destruction, and the names of the individuals who witness the destruction as well as their signatures and date signed. Retention period is for two years after the day of destruction. The laboratory is also required to hold pesticide test results for two years after the day the COA was created and produce them in a timely fashion upon request during inspection.

Other documents that must be retained for two years include organizational security plans, analytical test results, validated methods, SOPs, sanitation programs, notice of theft/loss, and qualifications of the head of laboratory, including both current and replaced versions of documents.[5][3][2]

23. Track-and-trace requirements

Canada mandates the use of the Cannabis Tracking System (CTS) by some entities as a means “to track only what is needed to monitor the flow of cannabis at a national level to meet regulatory requirements under the Cannabis Act.”[10] As of January 2019, the Cannabis Tracking System Order does not apply to analytical testing laboratories, though the record keeping and reporting requirements are still firmly in place. The government also adds that “further reporting requirements could be added as specific conditions to a license if deemed necessary.”[11]

References

  1. Porter, C. (11 November 2018). "Canada’s Message to Teenagers: Marijuana Is Legal Now. Please Don’t Smoke It". The New York Times. The New York Times Company. https://www.nytimes.com/2018/11/11/world/canada/marijuana-legalization-teenagers.html. Retrieved 13 November 2018. 
  2. 2.0 2.1 2.2 "Cannabis Licensing Application Guide: Application Requirements and Process to Become a Licence Holder under the Cannabis Act and its Regulations". Government of Canada - Health Canada. 19 December 2018. https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/industry-licensees-applicants/licensing-summary/guide.html. Retrieved 25 January 2019. 
  3. 3.0 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 "Mandatory cannabis testing for pesticide active ingredients - Requirements". Government of Canada - Health Canada. 08 November 2018. https://www.canada.ca/en/public-health/services/publications/drugs-health-products/cannabis-testing-pesticide-requirements.html. Retrieved 25 January 2019. 
  4. 4.0 4.1 4.2 4.3 Li, H.; Adeli, K. (2009). "Laboratory quality regulations and accreditation standards in Canada". Clinical Biochemistry 42 (4–5): 249–55. doi:10.1016/j.clinbiochem.2008.09.006. PMID 19863915. 
  5. 5.00 5.01 5.02 5.03 5.04 5.05 5.06 5.07 5.08 5.09 5.10 5.11 5.12 "Cannabis Regulations SOR/2018-144". Justice Laws Website. Government of Canada. 08 January 2019. https://laws-lois.justice.gc.ca/eng/regulations/SOR-2018-144/FullText.html. Retrieved 25 January 2019. 
  6. "Q2B: Validation of Analytical Procedures: Methodology". Government of Canada - Health Canada. 12 February 1999. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/international-conference-harmonisation/quality/validation-analytical-procedures-methodology.html. Retrieved 25 January 2019. 
  7. "Limits for Residual Solvents in Cannabis Products". Government of Canada - Health Canada. 08 November 2018. https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/laws-regulations/regulations-support-cannabis-act/limits-residual-solvents.html. Retrieved 25 January 2019. 
  8. 8.0 8.1 "Food and Drugs Act, Schedule B". Justice Laws Website. Government of Canada. 08 January 2019. https://laws-lois.justice.gc.ca/eng/acts/F-27/page-11.html#h-26. Retrieved 25 January 2019. 
  9. 9.0 9.1 "Mandatory cannabis testing for pesticide active ingredients - List and Limits". Government of Canada - Health Canada. 08 November 2018. https://www.canada.ca/en/public-health/services/publications/drugs-health-products/cannabis-testing-pesticide-list-limits.html. Retrieved 25 January 2019. 
  10. "Cannabis tracking system under the Cannabis Act". Government of Canada - Health Canada. 14 January 2019. https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/tracking-system.html. Retrieved 25 January 2019. 
  11. "Cannabis Tracking System Order: SOR/2018-178". Canada Gazette - Part II 152 (18). September 2018. http://gazette.gc.ca/rp-pr/p2/2018/2018-09-05/html/sor-dors178-eng.html. Retrieved 25 January 2019.