Edible Cannabis and the SFCR: Health Canada’s Proposed Adaptations
The Miriam-Webster definition of “edible” includes that of “a food item.” The dictionary may have to rewrite that definition for Canadians. In December, 2018, Health Canada proposed that edible cannabis not be treated as a food under the Food and Drugs Act and Safe Food for Canadians Act (SFCA), even though it meets the definition of “food.” Rather, because the Cannabis Exemption of the Food and Drugs Act regulations exempts cannabis produced by authorized persons, Health Canada has proposed regulation for three new classes of cannabis (edible cannabis, cannabis extracts, and cannabis topicals) to be regulated exclusively under the Cannabis Act and the Cannabis Regulations. On Friday, June 14, the Government of Canada announced that the final regulations will be published on June 26 and they will come into effect on October 17, however, the products will not be available in cannabis stores until December 17, 2019. (Watch for a TAG newsletter on the final regulations once released.)
To effect this, Health Canada intends to issue a notice of intent clarifying that edible cannabis would not be treated as a “food” and would be controlled exclusively under the Cannabis Act and its regulations, thus not subject to the Safe Food for Canadians Regulations (SFCR). However, relevant provisions of would be incorporated or adapted into the Cannabis Regulations, thereby creating consistency.
What are those relevant provisions and how do the Cannabis regulations compare with the SFCR? Following are key proposed public health and safety regulations based on, or differing from, SFCR rules:
Licencing. Edibles processors would need to be licensed under the Cannabis Regulation, but would not be required to obtain an additional licence under the SFCR. There is, however, some lack of clarity on the import aspect of this. Licensed cannabis edibles manufacturers don’t need an SFCR licence to produce, but they may need an SFCR licence for importing of food ingredients. This has not yet been clarified by CFIA or Health Canada.
Recalls. A recall provision adapted from an SFCR requirement would require edibles processors to establish and maintain a system of control to support efficient product recalls, for which they would be required to conduct a recall simulation at least once a year to evaluate the effectiveness of their recall systems and processes. Additionally, a written document would be required to describe how the simulation was conducted and its results, and be kept for at least two years.
Good production practices. Part 5 of the regulations establishes requirements pertaining to good production practices in the production, distribution and storage of cannabis to control the quality. Additional good production practices are proposed to prevent contamination and address the risk of foodborne illness, many of which are adapted from the SFCR, including:
Equipment cleanliness requirements would be expanded to include conveyances (anything used in the facility to transport cannabis or ingredients; e.g., a forklift or hand lift), consistent with the SFCR. This requirement would apply to both cultivators and processors.
A ventilation system that provides clean air and removes unclean air that may have a negative impact on the cannabis or ingredients would be required. These measures, applying to cultivators and processors, are intended to prevent contamination, and are consistent with measures under the SFCR.
Sanitation program requirements would be expanded to explicitly require hand cleaning/sanitizing stations and lavatories in buildings where cannabis is produced, if necessary, to prevent the contamination of cannabis or ingredients. A new requirement (applying to processors only) pertains to employee clothing, footwear, and protective coverings. Both new requirements are consistent with the SFCR.
Existing controls designed to prevent the contamination of cannabis would be expanded for processors to cover ingredients.
Consistent with the SFCR, processors that produce edibles or extracts would be required to prepare, retain, maintain and implement a written preventive control plan (PCP). The PCP is to identify and address, through effective control measures, any potential hazards that pose a risk to their production; be signed off on by the quality assurance person (QAP) prior to implementation; then include documents to substantiate that it has been implemented.
Processing employees who conduct activities involving edible cannabis or ingredients would be required to have the necessary competencies and qualifications to carry out their duties, consistent with the SFCR.
Currently, the QAP is required to investigate every complaint received about the quality of the cannabis and to take measures to address any identified risk. In addition, the QAP would be required to proactively conduct an investigation any time they suspect that cannabis or an ingredient may present a risk of injury to human health or does not meet requirements in parts 5 or 6 of the Regulations, and, if necessary, immediately take measures to mitigate any risk. The proposed new requirement, which is adapted from the SFCR, would apply, for example, in a situation where the QAP suspects that an ingredient may have been improperly stored, resulting in contamination that presents a risk to human health.
Processors would need to ensure that steps are taken so that animals and pests are not able to enter any building or part of a building where cannabis is being processed. While this requirement is taken from the SFCR, it would apply to all cannabis processors, not just edibles.
Any water (including ice or steam used in production) that contacts cannabis or an ingredient must be potable, unless the water does not present a risk of contamination, consistent with the SFCR. This requirement would apply to all processors producing the new classes of cannabis.
Additional Contamination Prevention. A number of measures are proposed to prevent the contamination of cannabis or ingredients, e.g., processors would be required to separate incompatible activities and ensure that contaminated waste is disposed of properly; edible cannabis processors would be required to identify and place contaminated ingredients in a designated area, also consistent with the SFCR. The requirement to prepare standard operating procedures for the production, packaging, labelling, distribution, storage, sampling, and testing of cannabis would be amended to also pertain to the handling of ingredients, and must specify that all such activities be conducted in accordance with the requirements of parts 5 and 6 of the Regulations. (Currently, section 80 applies only to cannabis, and specifies only that activities must be conducted in accordance with Part 5.)
Co-production. Edible cannabis could be produced at a site where conventional food products are being manufactured only if the edible cannabis is produced in a separate building on the site. This is intended to mitigate against associated food safety and public health concerns, particularly the risks of cross-contamination between ingredients and products, mislabeling, and product mix-ups. It also provides Canada’s international trade partners or importers of Canadian food products with assurance that there can be absolutely no cross-contamination of Canadian food products with cannabis.
Packaging. “Food-grade” packaging (i.e., that which meets SFCR requirements for food) would be required for the immediate container of edible cannabis and any wrappers.
In addition to these, a number of regulatory provisions intended to reduce the appeal of such products to youth and the risks of overconsumption and accidental consumption have been proposed to address the public health and public safety risks posed by the new classes of cannabis.
Led by Dr. David Acheson, HashTAG is part of The Acheson Group (TAG), a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With a focus on the Cannabis Edibles Industry, the HashTAG team brings in-depth industry knowledge combined with real-world experience to help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. To learn more about HashTAG services and expertise, please visit: www.HashTAG.global