Cannabis and Canadian Environmental Protection Act

 In Cannabis

By: Joe McCarthy, Lab Service Manager/Senior Regulatory Affairs Specialist, email

Under the Canadian Environmental Protection Act Section 81, no person shall manufacture or import a substance that is not included on the Domestic Substances List (DSL) unless a Notification has been submitted under the New Substances Notification Regulations.

The following Cannabis Substances are not listed on the DSL.

SubstanceCAS#
Cannabidiol (CBD)13956-29-1
Cannabinol (CRM)521-35-7
Δ9-Tetrahydrocannabinol (THC)1972-08-3
Cannabis sativa seed oil8016-24-8
Cannabis Sativa Flower Extract89958-21-4

There are some exemptions to the CEPA requirement that a substance must be listed on the DSL before it is manufactured or imported in Canada.

Substances Occurring In Nature

Under the New Substances Program, substances occurring in nature are not subject to the New Substances Regulations. To be defined as naturally occurring substances “must be unprocessed; processed only by manual, gravitational or mechanical means, by dissolution in water, by flotation or by heating solely to remove water; or extracted from air by any means.”

 Cold pressing of seeds to extract oil is a mechanical means and as such would be considered Substances Occurring in Nature.

Extraction of substances with butane, CO2, ethanol, petroleum ether, naphtha or other solvents do not meet the requirements of the Substances Occurring in Nature exemption.

Exempt from CEPA by Regulation Through Another Act

If the substances are regulated under any Act of Parliament which provides for notice to be given before the manufacture, import or sale of the substance, and for an assessment of whether it is toxic or capable of becoming toxic, the substance is exempt from the CEPA. New Substance requirements if the Act is included in Schedule 2 of CEPA.

Currently Schedule 2 of CEPA includes the:

  • Pest Control Products Act/Pest Control Products Regulations
  • Fertilizers Act/Fertilizers Regulations
  • Feeds Act/Feeds Regulations
  • Schedule 2 of CEPA does not include the:
  • Food & Drugs Act/Food & Drug Regulations/Cosmetic Regulations/Natural Health Products Regulations.
  • Cannabis Act/Cannabis Regulations/Industrial Hemp Regulations.

Revised In Commerce List (R-ICL)

The Revised In Commerce List are substances which were in products that were regulated under the Food & Drugs Act and that were in Canadian commerce between 01 January 1987 and 13 September 2001.

Substances on the R-ICL and used only in a Food and Drugs Act (FDA) regulated product while subject to CEPA will not be required to submit New Substances Notifications.

THC- Δ9-Tetrahydrocannabinol (CAS#1972-08-3) is listed on the R-ICL

Cannabidiol (CBD), Cannabinol (CRM), Cannabis sativa seed oil and Cannabis Sativa Flower Extract are not listed on the R-ICL.

Executive Summary

The manufacture or import of more than 100 kg/yr of Cannabidiol (CBD), Cannabinol (CRM) or other phytocannibinoids, even if authourized under the Cannabis Act, are not exempt from the Canadian Environmental Protection Act/New Substances Notification Regulations.

Need help on how, where and when to submit a New Substances Notifications?

Contact:
Dell Tech Laboratories
Joe McCarthy, Senior Regulatory Affairs Specialist
jmccarthy@delltech.com
519-858-5024

More info on New Substance Notifications


Dell Tech has provided professional, confidential consulting services to the chemical specialty industry in Canada, USA, Europe and Asia for the last 39 years.  Contact us today for more information.

www.delltech.com

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