Skip to content

Client Update: Canada’s Proposed Cannabis Edibles, Extracts and Topicals Regulations Revealed

Kevin Landry

The first look at regulations for cannabis edibles, extracts and topicals has arrived. The Federal Government has opened a 60-day consultation period respecting the strict regulation of additional cannabis products. Notice of the consultation was accompanied by release of a document titled: Proposed Regulations Amending the Cannabis Regulations (New Classes of Cannabis) And Proposed Order Amending Schedules 3 and 4 to the Cannabis Act (“Consultation Paper”).

The Consultation Paper outlines proposed amendments to the Cannabis Regulations and Cannabis Act which would result in the legalization of several new forms of cannabis by October 17, 2019 or sooner:

  • Cannabis edibles: products containing cannabis that are intended to be consumed in the form of food or beverages;
  • Cannabis extracts: derivatives and vaping products that are produced using extraction processing methods or by synthesizing phytocannabinoids; and
  • Cannabis topicals: products intended to be used on external body surfaces (i.e., skin, hair and nails) that include cannabis as an ingredient.

Interested parties have until February 20, 2019 to complete an online questionnaire, or send a written submission to the Cannabis Legalization and Regulation Branch before the final regulations are published in the Canada Gazette Part II.

How will edibles, extracts and topicals be regulated?

Amending Schedule 4 of the Cannabis Act

Schedule 4 of the Cannabis Act outlines types of cannabis that may be sold by licensed parties. The Consultation Paper proposes to amend Schedule 4 of the Cannabis Act by Order in Council to add edibles, extracts and topicals to the list of cannabis types that could be legally sold by federal licence holders and other authorized distributors and retailers.

Transitional provisions in the Consultation Paper would remove cannabis oil from Schedule 4 six months after the amended Cannabis Regulations come into force. Following the six-month transition period, cannabis oil would be still be permitted but would be governed under the newly introduced classes of cannabis.

Processing licenses required

Instead of creating a new license specifically for edibles, extracts and topicals, the Consultation Paper would require manufacturers, and those who package and label edibles, extracts or topicals for sale to consumers, to hold a micro or standard processing license. There are no changes to current Cannabis Act personnel requirements, application process or physical security requirements for processing of edibles, extracts or topicals.

The proposed regulations would require edibles, extracts and topical products to be processed in a separate building from any facility that produces conventional food products.

Adjustments to good production practices

In general, the Consultation Paper proposes requirements consistent with the Safe Food for Canadians Regulations (“SFCR”) particularly with respect to edible products so as to avoid issues with contamination and sanitation. In keeping with the SFCR, the Consultation Paper introduces a requirement for a written Preventive Control Plan (“PCP”) which each licensed processor must implement. The PCP will identify and address any potential hazards or risks to the production of these new classes of cannabis. The licensed processor’s Quality Assurance Person (“QAP”) would be required to verify and approve the PCP prior to its implementation.

Other ancillary amendments will require solvent testing, variability limits, bans on pets in processing facilities, proactive investigation by the QAP into ingredients which may pose a threat to human health, adjustments to licensed processor’s standard operating procedures to include provisions for handling of ingredients and requirements pertaining to the use of potable water in processing activities.

Quality Assurance Person credentials

The skill and experience required of QAPs will change if the proposed regulations are accepted as written. QAPs will require sufficient qualifications to oversee the production of all classes of cannabis the licensed processor is producing. Should current QAPs not have appropriate knowledge, the licensed processor will be expected to retain the services of another individual with skills sufficient to oversee production of these new classes of cannabis.

All license holders to be subject to recall simulations

Current requirements for seed to sale tracking on all cannabis produced is intended to facilitate product recalls. The Consultation Paper builds on those requirements and would force all licence holders to conduct a recall simulation once every year to evaluate the effectiveness of their recall systems and processes and prepare a report outlining how the simulation was conducted and the results.

THC limits

The Consultation Paper proposes limits on the amount of Tetrahydrocannabinol (“THC”) in edibles, extracts and topicals. Limits are placed both on “discrete units” (individual servings) and on the total THC in a single package of any product:

  • Cannabis edibles: limit of 10 milligrams of THC per discrete unit and per package.
  • Cannabis extracts: limit of 10 milligrams of THC per discrete unit and limit of 1,000 milligrams (1 gram) of THC in a single package.
  • Cannabis topicals: limit of 1,000 milligrams (1 gram) of THC in a package.

Restrictions on edibles

All edible cannabis products must be shelf-stable and cannot contain additives like vitamins or mineral nutrients. Given that edibles cannot require refrigeration or freezing, and that meat, poultry and fish ingredients would be prohibited (other than in dried forms) the proposed regulations raise questions about the viability of cannabis-infused items eventually being served in restaurants by chefs and others pursuing that variety of cannabis cuisine.

0.03 grams (3 milligrams), of caffeine per package will be permitted in edible cannabis products but the presence of caffeine is limited to caffeine present in edible products through the use of ingredients containing naturally occurring caffeine.

Restrictions on extracts

Because 0.025 grams of cannabis extract are deemed the equivalent of 1 gram of dried cannabis, and because no person may possess more than 30 grams of dried cannabis (or equivalent) a maximum package size of 7.5 grams will be imposed for cannabis extracts.

Restrictions on packaging and labels

The Consultation Paper introduces several amendments to packaging and labeling requirements:

  • Terms such as “beer” or “wine” and elements associated with alcoholic beverages or brands would not be permitted on cannabis products.
  • Representations regarding health benefits such as “a healthy diet low in saturated and trans fat may reduce the risk of heart disease”, or “oat fibre helps lower cholesterol” will be prohibited for cannabis products.
  • Representations regarding cosmetic benefits, such as “reduces the appearance of wrinkles” or “softens skin” will be prohibited for cannabis products.
  • Packages too small to hold Health Canada warning labels and messaging will be permitted fold out panels on packaging to ensure they display required information.
  • A 90 millilitre size limit will be imposed on all liquid cannabis extracts.

This update is intended for general information only. If you have questions about the above, please contact a member of our Cannabis group.

SHARE

Archive

Search Archive


 
 

SVILA E-Discovery

March 5, 2013

Stewart McKelvey’s Vision Improving Legal Analysis (SVILA*) is an e-discovery project and litigation management tool. For more information on our e-discovery services, download the SVILA e-discovery document.

Read More

Doing Business in Atlantic Canada (Spring 2013)(Canadian Lawyer magazine supplement)

March 5, 2013

IN THIS ISSUE: A New Brunswick business lawyer’s perspective by Peter Klohn Why Canada’s immigration rules matter to your business by Andrea Baldwin Financing Energy Projects during the Project Lifecycle by Lydia Bugden, Colm St. Roch Seviour and Tauna Staniland Download…

Read More

Client Update: Valentine’s Day @ the Workplace

February 14, 2013

Yellow diamonds in the light And we’re standing side by side As your shadow crosses mine What it takes to come alive It’s the way I’m feeling I just can’t deny But I’ve gotta let…

Read More

Client Update: Nova Scotia Contaminated Site – Ministerial Protocols

January 11, 2013

INTRODUCTION On December 6, 2012, The Nova Scotia Department of Environment (NSE) released Draft Ministerial Protocols (the “Draft Protocols”) related to contaminated sites. The release of the Draft Protocols has been eagerly anticipated. The adoption…

Read More

Client Update: Changes to the Rules of the Supreme Court

January 3, 2013

Recent changes to the Rules of the Supreme Court, 1986, SNL 1986, c 42, Sch D On December 14, 2012, several changes were made to the Rules of the Supreme Court. These changes include: who may act…

Read More

Doing Business in Atlantic Canada (Winter 2012) (Canadian Lawyer magazine supplement)

January 1, 2013

IN THIS ISSUE: Putting Trust in your Estate Planning, by Paul Coxworthy and Michael McGonnell The Risks, for Insurers in Entering Administration Services Only (ASO) Contracts, by Tyana Caplan Angels in Atlantic Canada, by Allison McCarthy, Gavin Stuttard and Adam Bata…

Read More

Client Update – Changes to the Human Rights Legislation in Newfoundland and Labrador

July 13, 2010

Bill 31, An Act Respecting Human Rights, came into force on June 24, 2010 replacing the Human Rights Code (the “Code”). For more information, please download a copy of this client update.

Read More

Atlantic Business Counsel – December 2009

December 18, 2009

IN THIS ISSUE Expanded Fines and Penalties for Environmental Offences: The New Federal Environmental Enforcement Act Spam about to be Canned? Preparing a Business for Sale Business Disputes Corner – Place of Arbitration and Selected…

Read More

Client Update – General Damage Cap Upheld By the Nova Scotia Court of Appeal

December 15, 2009

The Nova Scotia Court of Appeal has unanimously upheld the province’s legislative limits on general damage recovery for “minor injuries”. Today’s decision, authored by Chief Justice Michael MacDonald, completely affirms the January 2009 decision of…

Read More

Client Update – New Planning Opportunities For ULCs

December 4, 2009

The Canada Revenue Agency (“CRA”) announced helpful administrative positions concerning the new rules under the Fifth Protocol to the Canada-US Income Tax Convention, 1980 which will come into effect on January 1, 2010. The CRA…

Read More

Search Archive


Scroll To Top