On October 17, 2019, the amended Cannabis Regulations came into force permitting the legal production and sale of edible cannabis, cannabis extracts, and cannabis topicals in accordance with the requirements set forth under the Cannabis Act (CA) and its regulations. From this day forward, licensed processors would be able to manufacture new classes of cannabis products that could be purchased by consumers through various legal outlets depending on where they reside in Canada.
In addition to the new classes of cannabis products that could be legally produced and sold under the amended regulations, there came new regulatory and quality requirements that holders of a processing licence must adhere to. Depending on the new class(es) of product(s) they intend to manufacture, licence holders, are also required to demonstrate compliance with respect to regulatory requirements specific to those classes in particular. Using edibles as an example, licence holders would need to ensure that edible cannabis products do not contain any ingredients other than food and food additives (s. 102(1), Cannabis Regulations (CR)). This article will focus specifically on the new requirements applicable to licence applicants and holders who wish to produce edible cannabis products.
Before going into detail regarding these new requirements, it is important to note that although edible cannabis products can be ingested by a consumer and contain ingredients that are food and food additives, the Food and Drugs Act and its regulations do not apply to edible cannabis. There are specific situations where cannabis and activities with cannabis are subject to the Food and Drugs Act in addition to the Cannabis Act, and that is when the cannabis is represented with a therapeutic claim. It is also important to note that the Safe Food for Canadians Act (SFCA) and its regulations also do not apply to edibles cannabis. However, certain elements of the new requirements pertaining to edible cannabis in the Cannabis Regulations were adapted from this framework.
As mentioned above, in regard to the production of edible cannabis, there are a number of new requirements that licence applicants and holders must comply with should they wish to produce edible cannabis products. Information regarding some, not all, of the new requirements, has been provided below.
**Please note that some requirements mentioned below are also applicable to other classes of cannabis product however for the purposes of this article we will be focusing specifically on edible cannabis.
Requirements for the Production of Edible Cannabis
Staffing: If you are looking to produce cannabis edibles, having the right personnel on staff is an important consideration that needs to be made. A licence holder must ensure that any individual who conducts activities in relation to edibles cannabis or anything used as an ingredient in the production of edibles cannabis is qualified to do so (s. 88.1, CR). Making sure your staff holds the appropriate competencies and qualifications in relation to these activities as well as a working knowledge of the application requirements and regulations is extremely important.
Facility Systems: Another important consideration to be made if you’re looking to produce cannabis edibles are the systems that have been implemented at your facility in terms of temperature, humidity, heating and cooling and how these variables are controlled (s. 88.2, CR). Licence holders must also ensure that the temperature and humidity where cannabis or anything being used as an ingredient is produced, packaged, labelled, stored or tested are maintained at levels that are suitable for the activity that is being conducted. These precautions must be taken to ensure that bacterial growth and contamination as a result of the improper storage of cannabis and the ingredients being used are prevented.
Incompatible Activities: It is also important to know that if you already have a commercial production facility that is producing conventional foods (cookies, for example) that you are not permitted to produce cannabis edibles in the same facility. Licence holders must not produce, package, label or store cannabis at a site if the food that is to be sold is also produced at that site (s. 88.92, CR). What this means is that the co-location of cannabis production and conventional food production cannot take place. This isn’t to say production of the two couldn’t happen on the same site but that the two activities would have to be conducted in different buildings on the site. For applicants, this is an important consideration that needs to be made in order to ensure that resources are allocated effectively should they already have a facility that is producing conventional foods.
Identification and Analysis of Hazards: A new requirement that must now be met is the implementation of a plan that identifies and analyzes the biological, chemical and physical hazards that present a risk of contamination to the cannabis or anything being used as an ingredient in the production of cannabis edibles (s. 88.93, CR). Health Canada requires that for each edible cannabis, the biological, chemical and physical hazards that may be reasonably expected to contaminate the edible through inputs (i.e. ingredients and packaging materials), processing steps and traffic flows are identified by the licence holder. In addition, Health Canada requires that the appropriate steps are taken by the holder to prevent, eliminate or reduce to an acceptable level these hazards by utilizing control measures that, through supporting evidence, can effectively do so.
Preventative Control Plan (PCP): In addition to the identification and analysis of hazards in your production facility, another new requirement if you intend to produce edible cannabis is the implementation of a preventative control plan (PCP). Licence holders who conduct activities with edible cannabis must identify microbial, chemical, and physical hazards within their production facility. Additionally, they must prepare, retain, maintain and implement a written PCP for any activity they conduct with respect to cannabis or anything being used as an ingredient in the production of edible cannabis (s. 88.84, CR). This PCP must be able to demonstrate how hazards related to the production of cannabis and cannabis products are controlled, including the ingredients used in the production process and how all required regulatory requirements are met. Once again, not having an effective PCP plan implemented may have serious repercussions. One method for achieving an effective PCP plan is by using the HACCP (Hazard Analysis and Critical Control Point) method. According to the Canadian Food Inspection Agency (CFIA), “HACCP is recognized as the most respected food processing concept in the world for enhancing the production of safe food.” The approach taken by HACCP involves the review of each step in the manufacturing process, from beginning to end, to ensure that every possible hazard and/or source of contamination can be identified.
Whether your company has some level of a HACCP plan or PCP in place or if you are starting from scratch and a HACCP plan or PCP is new to your organization, dicentra Food Safety, and Quality Services are able to help you succeed in your next steps.
In addition to the items mentioned above, there are a number of other proposed regulations that may apply to you as a licence holder. Although this may seem overwhelming, the experts on staff at dicentra are readily available to assist you with all of your cannabis product and licensing needs. Be sure to contact us today if you have any questions or concerns regarding your cannabis product(s).
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dicentra Cannabis Consulting provides sought-after guidance on product and marketing compliance, quality assurance and safety standards, research and development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces. We can also assist you with your classification determinations for delivery systems or combination drug-device products.