( Disponible en anglais seulement )
Health Canada recently sought public feedback on potential amendments to the Cannabis Regulations (the “CR”), which were proposed to reduce current regulatory burdens while still addressing public health and safety risks.
Noting that the legal cannabis industry has matured since the coming into force of Canada’s Cannabis Act (the “Act”) and the CR in 2018, Health Canada has identified that there may be regulatory requirements that can now be made more efficient and less onerous. With that in mind, Health Canada indicated in the consultation notice that the potential amendments to the CR are intended to: “(a) streamline and clarify existing requirements; (b) eliminate inefficiencies in the regulations, such as duplications between requirements; and (c) reduce administrative and regulatory burdens, while continuing to meet the public health and public safety objectives of the Act.”
The potential regulatory amendments would target five priority areas addressed in the CR. Health Canada has received feedback that some requirements in these five areas are not necessary, are too burdensome, and could be streamlined. As a result, Health Canada is considering what changes it can make to these requirements, without compromising the public health and public safety objectives of the Act. Each of the five areas are set out below.
Under the Act, a person is required to obtain a licence to conduct various activities with cannabis. The CR set out rules and requirements that apply to each licence class (e.g. cultivation, processing, sale) and subclass (e.g. standard and micro). Health Canada is considering making changes to these licensing requirements based on feedback that some of the current requirements are unnecessary or not streamlined enough. For example, they have asked whether there are any activities that currently require a licence or permit that should not, or whether there are any activities not currently authorized that should be.
2. Personnel and physical security measures
License holders are currently required to comply with the personnel and physical security requirements set out in the CR. These requirements are specific to each type of license and include having a head of security, an organizational security plan, and physical security measures, such as visual recording devices. Health Canada has received feedback that some of these current requirements are not necessary or could be streamlined and is considering making regulatory amendments to address these concerns. It has asked whether there are any particular security requirements that could be changed without the risk of cannabis being diverted to an illicit market.
3. Production requirements for cannabis products
The CR outline regulatory requirements related to the formulation, production, and composition of cannabis products. These requirements are intended to reduce the appeal of cannabis products to young persons and reduce harmful or unintended responses to cannabis products, among other things. The requirements include, for example, microbial and chemical contamination limits and prohibited ingredients. Health Canada is considering regulatory amendments in response to feedback that some of these product requirements are overly burdensome compared to other analogous regulatory frameworks, such as the regulations for medical devices or cosmetics. It has asked whether there are concepts from other frameworks that should be considered for the Act and CR or if there are particular arears where changes could result in efficiencies, among other questions.
4. Packaging and labelling requirements for cannabis products
The CR establish 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, packaging cannabis products in child-resistant containers, and mandatory health warning messages. Health Canada is considering changes to the current packaging and labelling requirements to make them less onerous while still achieving the Act’s health and safety objectives. It has asked for opinions on what information should be included on packaging and labels, among other questions.
5. Record keeping and reporting for cannabis licence holders
The CR identify requirements for federal licence holders regarding retention of documents and reporting of certain information to Health Canada. These requirements include establishing and maintaining up-to-date inventories and retaining documents related to the production of cannabis products, good production practices, packaging and labelling, investors, and notices of new cannabis products to be sold in Canada for the first time. Health Canada is considering regulatory amendments to simplify the reporting process and remove duplicative requirements in the current framework.
Interested parties were asked to submit their input by email before the May 24, 2023 deadline, which has now passed. The submitted feedback is currently under review. Any future proposal on these issues will be pre-published in the Canada Gazette, Part I, for further stakeholder consultation before it is made final.
Should you have any questions regarding cannabis regulation compliance in Canada, please feel free to reach out to any member of Miller Thomson’s Marketing, Advertising and Product Compliance team.