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Canada Proposes to Streamline Requirements for Cannabis Regulations

The amendments cover five core aspects of cannabis regulations, namely, licensing, personnel and physical security measures, production requirements, packaging and labeling requirements, as well as record-keeping and reporting.

On June 8, 2024, Canada proposed amendments to certain regulations concerning cannabis, aiming to streamline current regulatory requirements for cannabis. Several key cannabis regulations are involved, including the Cannabis Act, the Cannabis Regulations, the Cannabis Tracking System Order, the Industrial Hemp Regulations, the Cannabis Exemption (Food and Drugs Act) Regulations, and the Natural Health Products Regulations.

These amendments cover five core aspects, namely, licensing, personnel and physical security measures, production requirements, packaging and labeling requirements, as well as record-keeping and reporting. Public comments can be sent to [email protected] before July 8. Details are as follows:

Background 

After years of development, Canada's legal cannabis industry and market have become relatively mature. Further streamlining the existing regulatory and administrative requirements will promote the healthy development of the industry while reducing the administrative burden on the government.

1. Key changes related to licensing 

Current requirements

Proposed requirements

Implications

All research, including non-human research, requires a license for research regardless of the quantity of cannabis that a person (individual or organization) will possess.

Organizations and individuals who use 30 gram or less of dried cannabis or its equivalent in their studies without human participants are no longer required to apply for a research license.

Qualified cannabis researchers would benefit from administrative cost savings.

Micro-cultivators must not exceed 200 m2 canopy size, micro-processors must not possess over 600 kg of dried cannabis (or equivalent) per year, and nurseries must neither have a canopy size of more than 50 m2, nor over 5 kg of harvested flowering heads.

The thresholds of micro-class licenses are increased, based on changes to cannabis's wholesale prices, by a factor of four.

Micro-cultivation: Canopy size: 800 m2

Micro-processing: Yearly possession (dried cannabis): 2,400 kg

Nursery: Canopy size: 200 m2; Harvested flowering heads: 20 kg

Existing micro-class license holders would gain advantages by operating at a higher capacity without needing to modify or acquire a new license. This could entice new businesses to enter the market with greater potential for growth.

Cultivation, research and industrial hemp license holders cannot sell pollen to other license holders.

Intra-industry sale of pollen is enabled.

Cultivation, research and industrial hemp license holders would benefit to diversify their research and business activities.

While items listed in Schedule 2 of the Cannabis Act are exempt, processing them can create derivatives considered cannabis, requiring a processing license under the Cannabis Regulations. However, the Industrial Hemp Regulations exempts non-viable industrial hemp grain derivatives with THC levels below 10 parts per million.

It is permitted to produce derivatives from the exempt Schedule 2 plant parts without a processing license, provided the derivative doesn't contain isolated or concentrated phytocannabinoids. THC testing requirements for hemp grain derivatives, as well as labeling, import, and export regulations for these products, are removed.

These changes would allow the import, export, sale, and processing of non-viable cannabis and industrial hemp seeds, roots, and stalks without requiring a license. This would significantly reduce the regulatory burden for cannabis and industrial hemp license holders operating these parts.

2. Key changes related to personnel and physical security measures 

Current requirements

Proposed requirements

Implications

Holders of licenses for cultivation, processing, sale for medical purposes authorizing possession, or a cannabis drug license must have security-cleared personnel on-site whenever activities with cannabis are being conducted.

Security-cleared personnel on-site is no longer required when activities with cannabis are being conducted, while other requirements that reduce the risk of diversion are maintained.

Holders of licenses for cultivation, processing, sale for medical purposes, possession authorization, or cannabis drugs would benefit from cost   savings as they would no longer need security-cleared personnel on-site at all times.

Strict physical security measures apply to standard-class license holders, sale for medical purposes with possession license holders, and cannabis drug license holders.

Some physical security measures are reduced, such as continuous visual recordings.

Standard-class license holders, sale for medical purposes with possession license holders, cannabis drug license holders and new license applicants at licensed sites would benefit from cost savings.

3. Key changes related to production requirements 

Current requirements

Proposed requirements

Implications

Pre-rolled dried cannabis size is limited to 1 g.

Repeal of 1 g limit on pre-rolled cannabis.

Eliminating the weight limitation for pre-rolled cannabis products would align this requirement with other cannabis products, fostering innovation in new product formats and sizes. This would benefit licensed processors and offer cannabis consumers a wider range of choices, including larger sizes if desired.

The use of ethyl alcohol in cannabis products is generally prohibited, with exceptions subject to authorization. Ethyl alcohol is only permitted in cannabis extracts for ingestion and edible cannabis, subject to specific restrictions.

For innovative product development and to align with other regulatory frameworks, limited use (up to 10 mg per activation) of ethyl alcohol in cannabis extracts intended for inhalation and in cannabis topicals is permitted.

Licensed processors would benefit from the ability to innovate and offer a wider range of products to meet market demands. Consumers would consequently enjoy a greater selection of cannabis products.

4. Key changes related to packaging and labeling requirements 

Current requirements

Proposed requirements

Implications

All product packaging must be opaque or translucent and of the same color. Cut-out windows are prohibited.

The cap and container are permitted to be different colors for all cannabis packaging. Cut-out windows or transparent packaging are permitted for dried cannabis, fresh cannabis and seeds.

Licensed processors would benefit from an expanded range of suppliers and materials, potentially leading to lower prices and more environmentally sustainable packaging options. Additionally, both processors and consumers would benefit from another way to share product information, allowing consumers to assess quality and make informed purchase decisions.

Wrappers are prohibited from having any image or information, other than the standardized cannabis symbol.

Images and information on wrappers are permitted if required by another statute, such as the chasing arrows recycling icon.

It would enable compliance with other statutes, if required.

Cannabi products are subject to the labelling of both the quantity of THC and CBD. Besides, the potential of the acid forms converting into THC or CBD is considered. The font size on the label should be smaller than the Health Warning Message.

Potency labelling is simplified to only requiring total THC and total CBD on the label and allowing the font size to be as large as the Health Warning Message.

Both consumers and point-of-sale representatives would benefit from the elimination of confusion caused by dual THC and CBD measurements (total and actual) on labels. Licensed processors would gain from the increased label space, enabling them to include more voluntary information about their products.

QR codes are prohibited to be on product labels or packages. Informational inserts and leaflets are prohibited. Accordion or peel-back labels are only permitted on small packages.

The use of QR codes on product packages or labels, as well as informational inserts and leaflets, are permitted. Accordion or peel-back labels are permitted on any sized package.

Licensed processors would be allowed to provide more information on their products to consumers, which helps consumers make better informed purchase decisions.

Equivalency statements are required for all products. Besides, a statement that no expiry date has been determined are required for dried or fresh cannabis, cannabis extracts and cannabis topicals.

The requirements for equivalency statements on cannabis product labels and the requirement to include "no expiry date has been determined" are repealed.

Licensed processors would have more label space to provide additional information on their products to consumers.

It is prohibited to package several immediate containers inside one exterior container, except for edible cannabis whose total THC does not exceed 10 mg in all containers and the properties of each immediate container are consistent.

Co-packing of all classes of cannabis up to the public possession limit of 30 g of dried cannabis or its equivalent is allowed.

Co-packing would benefit licensed processors by potentially improving the efficiency for wholesalers and product suppliers, leading to increased sales.

5. Key changes related to record-keeping and reporting

Current requirements

Proposed requirements

Implications

License holders must create and provide an annual report on promotion to Health Canada that includes any promotional expenses and a description of the promotion.

License holders would no longer need to provide an annual report on   promotion.

The cancellation of annual report can save cost for license holders related to preparing the annual report on promotion.

Licensed processors must notify Health Canada at least 60 days before selling any new cannabis product (excluding plants or seeds). This notice, known as the NNCP (Notice of New Cannabis Product), must include the product's cannabis class, a description (including brand name), and the expected sale date. This information must be kept for two years.

For dried and fresh cannabis products, NNCP is no longer required.

The cancellation of NNCP can save administrative cost savings for both license holders and Health Canada.

 

Tags : Canada
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