Vol. 149, No. 15 — July 29, 2015

Registration

SOR/2015-191 July 16, 2015

CONTROLLED DRUGS AND SUBSTANCES ACT

Regulations Amending the Narcotic Control Regulations (Synthetic Cannabinoids)

P.C. 2015-1081 July 16, 2015

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 55(1) (see footnote a) of the Controlled Drugs and Substances Act (see footnote b), makes the annexed Regulations Amending the Narcotic Control Regulations (Synthetic Cannabinoids).

REGULATIONS AMENDING THE NARCOTIC CONTROL REGULATIONS (SYNTHETIC CANNABINOIDS)

AMENDMENTS

1. (1) The portion of item 17 of the schedule to the Narcotic Control Regulations (see footnote 1) before subitem (1) is replaced by the following:

17. Cannabis, its preparations and derivatives, including

(2) Subitems 17(5), (6) and (7.1) of the schedule to the Regulations are repealed.

2. The schedule to the Regulations is amended by adding the following after item 17:

18. Synthetic cannabinoid receptor type 1 agonists, their salts, derivatives, isomers, and salts of derivatives and isomers — with the exception of ((3S)-2,3-dihydro-5-methyl-3-(4-morpholinylmethyl)pyrrolo[1,2,3-de]-1,4-benzoxazin-6-yl)-1-naphthalenyl-methanone (WIN 55,212-3) and its salts — including those that fall within the following core chemical structure classes:

(1) Any substance that has a 2-(cyclohexyl)phenol structure with substitution at the 1-position of the benzene ring by a hydroxy, ether or ester group and further substituted at the 5-position of the benzene ring, whether or not further substituted on the benzene ring to any extent, and substituted at the 3’-position of the cyclohexyl ring by an alkyl, carbonyl, hydroxyl, ether or ester, and whether or not further substituted on the cyclohexyl ring to any extent, including

(2) Any substance that has a 3-(1-naphthoyl)indole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted on the naphthyl ring to any extent, including

(3) Any substance that has a 3-(1-naphthoyl)pyrrole structure with substitution at the nitrogen atom of the pyrrole ring, whether or not further substituted on the pyrrole ring to any extent and whether or not substituted on the naphthyl ring to any extent, including

(4) Any substance that has a 3-phenylacetylindole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted on the phenyl ring to any extent, including

(5) Any substance that has a 3-benzoylindole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted on the phenyl ring to any extent, including

(6) Any substance that has a 3-methanone(cyclopropyl)indole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted on the cyclopropyl ring to any extent, including

(7) Any substance that has a quinolin-8-yl 1H-indole-3-carboxylate structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted on the quinolin-8-yl ring to any extent, including

(8) Any substance that has a 3-carboxamideindazole structure with substitution at the nitrogen atom of the indazole ring, whether or not further substituted on the indazole ring to any extent and whether or not substituted at the carboxamide group to any extent, including

(9) Any substance that has a 3-carboxamideindole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted at the carboxamide group to any extent, including

COMING INTO FORCE

3. These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations and the Order.)

Issues

Synthetic cannabinoids are substances that bind to and activate a particular type of cannabinoid receptor in human cells, namely Type 1, which results in psychoactive effects similar to those caused by tetrahydrocannabinol (THC). THC is the principal psychoactive component in cannabis. Substances that bind to and activate these receptors are called cannabinoid receptor Type 1 agonists. The chemical structures of synthetic cannabinoids may or may not be related to THC.

Currently, most synthetic cannabinoids are developed for illicit purposes by modifying the chemical structure of existing synthetic cannabinoids. The abuse of these synthetic cannabinoids poses a health risk due to the fact that they may be more potent than THC and that chemicals inappropriate for human consumption are often used in their illicit production. Harmful health effects relating to their use include cardiovascular problems and psychological disorders that may lead to hospitalization. To date, close to 400 chemical substances have been identified worldwide as potential synthetic cannabinoids. In Canada, over 100 of these synthetic cannabinoids have been identified. These synthetic cannabinoids are often added to herbal products and falsely marketed as “legal alternatives” to cannabis as they are not specifically listed under the United Nations Convention on Psychotropic Substances, 1971.

Background

The Controlled Drugs and Substances Act (CDSA) provides a legislative framework for the control of substances that can alter mental processes and that may cause harm to the health of an individual or to society when diverted or misused. Currently, over 300 substances are expressly listed in Schedules I to IV to the CDSA. Entries in the schedules may include terms such as “salts,” “derivatives,” “isomers,” “analogues,” etc., thereby capturing a range of substances that are related to the primary substances listed, but are not themselves individually listed in the schedules.

Most synthetic cannabinoids are not individually listed in the schedules to the CDSA and its regulations. They are captured however by the term “similar synthetic preparations” (contained in the heading for Item 1 of Schedule II to the CDSA, which pertains to cannabis), as that term captures substances with pharmacological similarity to THC. Nevertheless, given the rise in the prevalence of synthetic cannabinoids, Health Canada is of the view that their controlled status should be made more explicit.

While most synthetic cannabinoids are not currently controlled under United Nations drug control conventions, the International Narcotic Control Board, a quasi-judicial body established under the United Nations Single Convention on Narcotic Drugs, 1961, and the United Nations Office on Drugs and Crime, the executive body of the United Nations Commission on Narcotic Drugs, have urged signatories to the United Nations drug control conventions to take steps at the national level to address the illicit manufacture and trafficking of synthetic cannabinoids, as well as health and safety issues associated with their abuse. Countries such as Austria, Ireland, Luxembourg, Switzerland, the United Kingdom and the United States have already taken measures to control synthetic cannabinoids.

Objectives

The objective of these modifications is to amend Schedule II to the CDSA and the schedule to the Narcotic Control Regulations (NCR) in order to make more explicit the controlled status of synthetic cannabinoids. In so doing, the new entry is intended to better enable Health Canada and law enforcement agencies to administer and enforce provisions of the Act and its regulations with respect to these substances.

Description

These amendments remove the term “similar synthetic preparations” in Item 1 of Schedule II to the CDSA and Item 17 of the Schedule to the NCR and add a new item with respect to synthetic cannabinoids.

The new schedule entry specifically defines synthetic cannabinoids as cannabinoid receptor Type 1 agonists and would include their salts, derivatives and isomers, and the salts of derivatives and isomers. In the interest of clarity, it also specifies known structural classes of synthetic cannabinoids with examples of particular substances within each class. In addition, given the fact that new synthetic cannabinoids are primarily developed by modification of the core chemical structures of known synthetic cannabinoids, and that such processes may result in the substances being mixed with their derivatives or isomers, the salts, derivatives and isomers and the salts of derivatives and isomers of synthetic cannabinoids are also captured.

“One-for-One” Rule

The “One-for-One” Rule does not apply to these regulatory amendments, as there is no change in administrative costs to business. The legitimate uses of synthetic cannabinoids are already regulated under the CDSA and the NCR.

Small business lens

The small business lens does not apply to these regulatory amendments, as there are no costs associated with the amendments.

Consultation

Health Canada published on January 31, 2015, a Notice to Interested Parties in the Canada Gazette, Part I, to notify stakeholders and the general public regarding these regulatory amendments. One comment fully supporting the amendments was received. A World Trade Organization Technical Barriers to Trade notification was also published on February 10, 2015. No substantive comments were received.

Rationale

Synthetic cannabinoids are being illicitly developed and manufactured at a rapid pace, with new ones being created each year. Their emergence in the market as falsely marketed “legal alternatives” to cannabis has presented a health and safety risk to Canadians. Replacing the term “similar synthetic preparations” with a clear definition of the substances based on pharmacological activity, accompanied by a list of classes of core chemical structures of the known synthetic cannabinoids provides greater specificity. This improves the enforcement of the CDSA to protect the health and safety of Canadians.

Implementation, enforcement and service standards

These regulatory amendments will not result in significant changes to the Government of Canada, industries or Canadians. Any legitimate uses of synthetic cannabinoids are already regulated under the CDSA and the NCR. Federal, provincial and local law enforcement agencies are responsible for taking enforcement action in response to contraventions of the CDSA, including illicit activities involving synthetic cannabinoids.

These regulatory amendments will come into force on the day on which they are registered.

Contact

Denis Arsenault
Healthy Environments and Consumer Safety Branch
Health Canada
Main Statistics Canada Building
150 Tunney’s Pasture Driveway
Ottawa, Ontario
K1A 0K9
Email: OCS_regulatorypolicy-BSC_politiquereglementaire@hc-sc.gc.ca