• Consultation sur les éventuelles modifications au Règlement sur le cannabis
  • Consultation sur les éventuelles modifications au Règlement sur le cannabis
  • Consultation sur les éventuelles modifications au Règlement sur le cannabis

Consultation on potential amendments to the Cannabis RegulationsDaily news

Published 27 March 2023 par AQIC

CANNABIS ACT

Notice of Intent — Consultation on potential amendments to the Cannabis Regulations

Purpose of notice

This Notice of Intent is to inform Canadians and interested parties that Health Canada is seeking feedback on potential amendments to the Cannabis Regulations (CR) for regulatory burden reduction while still addressing public health and public safety risks. It also provides stakeholders with an opportunity to identify and comment on additional regulatory issues.

Background

The Cannabis Act (the Act) created a legal framework for the production, distribution, sale, import, export, and possession of cannabis in Canada based on a public health and public safety approach. Key public health and public safety objectives include protecting the health of young persons by restricting their access to cannabis, establishing a diverse and competitive market with small and large-scale cannabis producers that can displace the illicit market, and providing adults access to a quality-controlled supply of cannabis.

To help achieve these objectives, Health Canada strictly regulates activities involving cannabis. Regulatory measures in the CR include

  • licensing to authorize the production and sale of cannabis for medical and non-medical purposes;
  • personnel and physical security requirements for licence holders;
  • quality control requirements, including good production practices (GPP), contaminant testing, and limits on tetrahydrocannabinol (THC) content;
  • plain packaging and labelling for cannabis products; and
  • reporting and record-keeping requirements to help track the high-level movement of cannabis throughout the legal supply chain.

A number of policy principles guided the development of the regulatory framework for cannabis. This included risk- and evidence-based requirements informed by the best available science on potential harms and risks posed by cannabis, providing for a broad range of cannabis products to help displace the illicit market, and implementing experiences and lessons learned from other jurisdictions that legalized and regulated cannabis. It also included building on long-standing regulatory frameworks, including industrial hemp, tobacco, food, and cosmetics.

Since the coming into force of the Act and the CR in 2018, the legal cannabis industry has matured, the marketplace has evolved, and there is increased knowledge and data on public health and public safety risks associated with certain activities. Based on the implementation experience gained since the coming into force of the Act, and in keeping with the original policy principles, Health Canada recognizes there may be regulatory measures that could be made more efficient and streamlined without compromising the public health and public safety objectives in the Act.

The proposal

Health Canada is considering potential amendments to the CR that would (1) streamline and clarify existing requirements; (2) eliminate inefficiencies in the regulations, such as duplications between requirements; and (3) reduce administrative and regulatory burdens where possible, while continuing to meet the public health and public safety objectives in the Act.

Regulatory amendments would target the following five priority areas:

  1. Licensing;
  2. Personnel and physical security measures;
  3. Production requirements for cannabis products;
  4. Packaging and labelling requirements for cannabis products; and
  5. Record keeping and reporting for cannabis licence holders.

This proposal is separate and distinct from the Government of Canada’s legislative review of the Cannabis Act, the objective of which is to review the administration and operation of the Act with a focus on young persons, Indigenous persons and communities, personal cultivation; along with reviewing access to cannabis for medical purposes.

Questions to guide input from interested parties

Health Canada is particularly interested in receiving feedback on the five priority areas listed above. However, all input is welcome and should not be limited to responses to the questions posed below. Health Canada is also interested in feedback on regulatory measures that may be duplicative, redundant, or particularly onerous, and where there are opportunities to promote efficiencies. Please provide a rationale and/or evidence wherever possible, including the expected impact on the legal cannabis industry, consumers, and public health and public safety. These responses will help inform and prioritize items for regulatory development and will be reviewed carefully by Health Canada.

1. Licensing

Under the Act, a person is required to obtain a licence to conduct various activities with cannabis. The CR sets out rules and requirements that apply to each licence class (e.g. cultivation, processing, sale) and subclass (e.g. standard and micro). The licensing framework provides for the legal production of cannabis while mitigating public health and public safety risks and reducing the risk of cannabis being diverted to an illicit market.

Some licence holders have raised concerns that some licensing requirements may not be necessary or could be streamlined. Health Canada is considering changes to licensing requirements that would not compromise public health or public safety.

  1. Are there any activities with cannabis that are not currently authorized under existing licences that could be authorized? What specific activities, for which classes of cannabis, and for what classes and subclasses of licences? How would such changes streamline the regulations or lead to greater efficiencies?
  2. Are there any activities with cannabis that organizations should be able to carry out, without the need to hold a licence or permit (for example, the possession of small amounts of licit cannabis for the purpose of laboratory research)? What specific activities and for what classes of cannabis? What measures, including regulatory requirements, should apply to mitigate public health and public safety risks?
  3. What measures could be taken to increase flexibility for licensed cannabis processors and to reduce the burden on the Quality Assurance Person (QAP)?

2. Personnel and physical security measures

A licence holder must comply with the personnel and physical security requirements specific to their licence as per parts 3 and 4 of the CR. These requirements include having a head of security, an organizational security plan, and physical security measures, such as visual recording devices. The personnel and physical security requirements aim to mitigate public health and public safety risks and reduce the risk of cannabis being diverted to an illicit market, among others.

Health Canada has received feedback that certain personnel and physical security requirements may not be necessary or could be streamlined. Health Canada is considering changes to the personal and physical security measures without unduly increasing risks to public health or public safety.

  • Are there personnel security requirements that could be changed without increasing the risk of diversion or inversion of cannabis? What specific requirements, and for what classes and subclasses of licences? Why or why not?
  • Are there physical security requirements that could be changed without posing a risk to public safety (for example, no visual monitoring during “off-season” for outdoor cultivation)? What specific requirements, and for what classes and subclasses of licences? Why or why not?

3. Production requirements for cannabis products

Under Part 6 of the CR, there are regulatory requirements related to the formulation, production, and composition of cannabis products. These requirements include, but are not limited to, microbial and chemical contamination limits and prohibited ingredients. These requirements aim to reduce the appeal of cannabis products to young persons; reduce the risk of accidental consumption; mitigate the consequences of overconsumption; reduce the risk of foodborne illness; and reduce the potential for toxicity, dependence or other harmful or unintended responses to cannabis products (i.e. adverse reactions).

Health Canada has heard that there are product requirements that are more burdensome than those in analogous frameworks, such as those for medical devices or cosmetics. Health Canada is considering regulatory changes for some product requirements that would remove unnecessary burden while still supporting the public health and public safety objectives of the Act.

  1. Are there any changes to the current production requirements that could create efficiencies for holders of a micro-cultivation or micro-processing licence?
  2. Are there regulatory requirements from other relevant control frameworks, such as those for food, vaping products, or cosmetics, that Health Canada should consider? Why or why not? For which classes of cannabis?
  3. Are there certain production requirements that could be changed or eliminated for licensed processors that are limited in what activities with cannabis they are authorized to undertake (for example only authorized to store cannabis products)? Which requirements, and under what circumstances?
  4. Should the limits on the maximum quantity of delta-9-THC that can be contained in a cannabis product (by container and ingestible unit) apply to the sum total of all intoxicating cannabinoids found in the product? Why or why not? How could such a requirement be established in an efficient manner that is simple to comply with?

4. Packaging and labelling requirements for cannabis products

The CR sets out requirements for the packaging and labelling of cannabis and cannabis products for sale, distribution, or export. These requirements include plain packaging and labelling for all cannabis products to make packages less appealing to young persons. All cannabis products must also be packaged in a child-resistant container and when the product contains delta-9-THC, it must be labelled with the standardized cannabis (THC) symbol to lower the risk of accidental consumption. In addition, cannabis products must display a mandatory health warning message and include specific product information (e.g. class of cannabis, delta-9-THC and cannabidiol [CBD] information) to provide consumers with the information they need to make informed decisions before using cannabis.

Health Canada has received stakeholder feedback that some packaging and labelling requirements are onerous or unnecessary to achieve the Act’s public health and public safety objectives. Health Canada is considering what packaging and labelling requirements could be changed without compromising these objectives.

  1. Should Health Canada consider amending packaging requirements for dried and fresh cannabis?
  2. Are there labelling requirements that could be changed without public health or public safety impacts? What required information should remain, and what information could be removed? Why or why not?
  3. Do you have any suggestions to simplify the requirements to include delta-9-THC and CBD content information on product labels?
  4. Should the requirement to include delta-9-THC content information on product labels apply to the total of all intoxicating cannabinoids, such as delta-8-THC? Why or why not? How could such a requirement be established in an efficient manner that is simple to comply with?
  5. Are there other packaging and labelling requirements that Health Canada should consider for a regulatory amendment? Why and what is the current impact of these requirements on licence holders and consumers?

5. Record keeping and reporting for cannabis licence holders

The CR establish requirements for federal licence holders respecting the retention of documents and reporting of certain information to Health Canada. Requirements include establishing and maintaining up-to-date inventories and retaining documents such as those related to the production of cannabis products, GPP, packaging and labelling, investors, and notices of new cannabis products to be sold in Canada for the first time. These record-keeping and reporting requirements aid Health Canada in the retrieval of important information to verify regulatory compliance, support operational and policy development, and reduce the risk of inversion and diversion to the illicit market.

Some licence holders have raised concerns with respect to onerous and duplicative requirements. Health Canada is considering regulatory changes that would aim to eliminate duplication between requirements where possible, remove requirements that are not effective in supporting public health and public safety objectives in the Act, and simplify the reporting process.

  1. Are there record-keeping or reporting requirements for micro-class licence holders that could be reduced without affecting public health and public safety? If so, which requirements and why? What is the current impact of these requirements on micro-class licence holders?
  2. Should Health Canada remove the requirement to provide a promotion expenditure report to Health Canada? Why or why not?
  3. Should Health Canada remove the requirement to maintain a record of key investors? Why or why not?
  4. Do you have any suggestions to improve the efficiency of the requirement for licensed processors to provide Health Canada with advance notice of a new cannabis product?
  5. Are there other requirements that could be adjusted for record keeping and reporting?

Next steps

Health Canada will review and consider the input received following publication of this Notice of Intent to inform next steps, including a cost-benefit analysis of the regulatory proposal. Any future regulatory proposal would be prepublished in the Canada Gazette, Part I, for further stakeholder consultation in accordance with the Treasury Board of Canada Secretariat’s Cabinet Directive on Regulation before it is made final.

Public comments

The publication of this Notice of Intent initiates a 60-day public comment period. Health Canada is seeking feedback and comments on potential amendments to the CR. Input received will ensure that regulatory amendments are informed by and responsive to the cannabis industry, other interested parties, and the public. Health Canada welcomes input for 60 calendar days until May 24, 2023.

Contact information

Please submit your input by email to cannabis.consultation@canada.ca with the following title in the subject line: “Notice of Intent — Consultation on Potential Amendments to the Cannabis Regulations”.

John Clare 
Director General
Strategic Policy, Cannabis
Controlled Substances and Cannabis Branch

SOURCE: Health Canada