Canada has published its Final Regulations for New Cannabis Products: Edible Cannabis, Cannabis Extracts and Cannabis Topicals which take effect October 17, enabling licensed processors to begin selling these cannabis products. There will be a further delay in availability of these products after October 17, however, because companies will have to apply to Health Canada for authorization to sell these products and this may take until mid-December. Published as Amendments to The Cannabis Regulations (which regulates non-edible products), the regulations not only move Canada to the next level of legality, but can provide a foundational example for other countries (e.g., the U.S.) that may be considering such legislation. Particularly applicable is Health Canada’s close tracking of the new regulations with those of the Safe Food for Canadians Regulations (SFCR); similarly the U.S. FDA could focus on provisions of the Food Safety Modernization Act (FSMA) as a basis for the use of CBD (and eventually THC) in foods and dietary supplements. Key to the amendments is the replacement of the terms “edibles containing cannabis” and “cannabis concentrates” with three new classes: “edible cannabis,” “cannabis extracts,” and “cannabis topicals.” Additionally, the term “cannabis oil” will be deleted one year after the amended regulations come into force (i.e., on October 17, 2020). Licensed processors may begin producing product prior to October 17, but those products cannot be sold, distributed, or exported, unless the applicable good production practices, products, and recordkeeping requirements were met at the time. Additionally, the Quality Assurance Person (or a retained qualified individual) must have the necessary qualifications applicable to the class of cannabis produced during this time. The most significant amendments to the Regulations are made to Part 5 (Good Production Practices), Part 6 (Products), Part 7 (Packaging and Labeling), and Part 11 (Recordkeeping); with a new Part 6.1 (Promotion) added. This week’s newsletter provides overviews of Parts 5 and 6. Next week, we will focus on Parts 7 and 11. PART 5. GOOD PRODUCTION PRACTICES Part 5 of the Regulations establishes requirements pertaining to the production, distribution and storage of cannabis to control the quality, with many provisions adapted from the SFCR to address the risk of foodborne illness associated with edible cannabis. As in the SFCR all cannabis edibles and extract production will require Food Safety and Regulatory Preventive Control Plans similar to USFDA FSMA PCPs for Human Food. The requirements apply only to activities involving ingredients that are conducted by a license holder, not to the ingredient manufacturers as they are already covered by other Acts and Regulations. These include: Requirements that pertain to the cleanliness of equipment also include conveyances. A ventilation system (natural or mechanical) must provide clean air and remove unclean air that may have a negative impact on the cannabis or ingredients. Hand cleaning and sanitizing stations and lavatories are required, if necessary, to prevent contamination, and processors must follow new employee clothing, footwear, and protective covering requirements. Existing controls to prevent the contamination of cannabis also apply to ingredients. Processors that produce edible cannabis or cannabis extracts must prepare, retain, maintain and implement a written preventive control plan (PCP) which must be signed off by the QAP and include documented evidence of implementation. Processing employees who conduct activities involving edible cannabis or ingredients must have the necessary competencies and qualifications to carry out their duties. In addition to investigating every complaint received in respect to the quality of the cannabis and taking measures to address any identified risk, the QAP must proactively investigate any suspected noncompliance or health risk of the cannabis or an ingredient, with immediate action to mitigate any confirmed risk. Steps must be taken to keep animals out of any building or part where cannabis is being produced. Any water (including that for ice or steam) that contacts cannabis or an ingredient must be potable, unless it does not present a risk of contamination. Contaminated waste must be properly disposed of and contaminated ingredients identified and placed in a designated area. If cannabis and food products are processed on the same site, the production, packaging, labelling, and storage of the cannabis and the food products must be conducted in separate buildings. Sampling and testing requirements include final cannabis product testing for THC, CBD and CBDA content; microbial and chemical contaminants; residues of solvents used in the production of cannabis oil; and dissolution or disintegration testing (on discrete units intended for ingestion or nasal, rectal, or vaginal use). Microbial and chemical contaminant testing can be conducted on either the final form of a cannabis product, or at the final step in production during which contaminants could be introduced or concentrated (i.e. on the “input” cannabis). But for edible cannabis, contaminant testing must be conducted on the “input” cannabis. Microbial and chemical limits must be within the limits appropriate for the intended use. PART 6. PRODUCTS Part 6 of the Amendments establishes rules for production, including THC limits, product composition, and ingredients. THC Limits. In addition to a maximum quantity of cannabis per package and public possession limit of 7.5 grams of cannabis (30 grams dried cannabis) for edibles, extracts, or topicals containing more than 3% w/w THC, specific limits for each are: Edible cannabis: a limit of 10 mg THC per discrete unit and immediate container. (e.g., a container could contain one discrete unit of 10 mg THC or two discrete units of 5 mg each.) Cannabis extracts: a limit of 10 mg THC per discrete unit that is intended to be ingested or for nasal, rectal, or vaginal use, such as a capsule, and a limit of 1,000 mg (1 gram) per immediate container. (e.g., 100 capsules of an extract of 10 mg each; or 200 capsules of 5 mg each). Cannabis topicals: a limit of 1,000 mg (1 gram) THC in an immediate container. Also, a lower possession limit and limit on the quantity of cannabis per package apply to any cannabis product that contains more than 3% THC by weight. Variability Limits are included for the quantity of THC and CBD in a cannabis product. Edible cannabis: If the total labeled quantity of THC or CBD exceeds 5 mg, the product is subject to a 15% variability limit (i.e., the container and any discrete units cannot contain less than 85% of that amount, or more than 115%). If the labeled quantity of THC or CBD is more than 2 mg but less than 5 mg, the variability limit is 20%; if it is less than 2 mg, the limit is 25%. Cannabis extracts and topicals: the variability limit is 15%. Other Form-Specific Requirements include (in brief): Edible cannabis products must be shelf-stable (i.e., not require refrigeration or freezing); can have only food and FDR-approved food additives as ingredients; cannot contain poisonous or harmful substances or be fortified with vitamins or mineral nutrients; must follow food safety regulations of the Food and Drugs Act (FDA); cannot contain a food described in an FDR-issued Temporary Marketing Authorization Letter; cannot contain meat, poultry, or fish, except authorized dried products. Additional limitations include those for hermetically sealed packaging, naturally occurring caffeine, and ethyl alcohol. Cannabis extracts. Flavoring agents, one or more carrier substances, and substance necessary to maintain the quality or stability of the product can be used, but sugars, sweeteners, or sweetening agents are not allowed, nor is any vaping product-prohibited ingredient (as listed in Column 1 of Schedule 2 to the Tobacco and Vaping Products Act) unless it and its level is naturally occurring in an ingredient. Any ingredient, except flavoring agents, intended to be inhaled must comply with a standard referenced in Schedule B to the FDA. Ethyl alcohol is permitted in products intended to be ingested that have a maximum product net weight per container of 7.5 g, regardless of the THC content of the product. (Other controls are included in the “Packaging and labelling” section.) Additionally, extracts cannot contain, or have on them, anything that may cause harm to consumer health when used as intended or in a reasonably foreseeable way. Cannabis topicals. Cannabis topical products cannot contain, or have on them, anything that may cause harm to consumer health when used as intended or in a reasonably foreseeable way, including those in Health Canada’s Cosmetic Ingredient Hotlist. Cannabis accessories. A cannabis accessory containing or packaged with cannabis (e.g., a pre-filled vaping cartridge) must not be contaminated; cannot, through any means other than heating or combustion, alter or enhance the effects of the product; increase the potential for physical dependence on the product; or increase the toxicity of the cannabis product when used as intended or in a reasonably foreseeable way. The maximum quantity of THC dispensed per activation of a cannabis accessory containing or packaged with an extract that is intended to be ingested, or for nasal, rectal, or vaginal use (e.g. a spray bottle) is 10 mg. (Additional requirements are included in the packaging section.) PART 6.1. PROMOTION. Unless authorized under the Act, it is generally prohibited to promote cannabis, a cannabis accessory, or any service related to cannabis (including its price or distribution) in a manner that could be appealing to young persons; through a testimonial or endorsement; by the depiction of a real or fictional person, character or animal; or in a manner that associates it or a brand element with, or evokes a positive or negative emotion about or image of, a way of life (e.g., glamour, recreation, excitement, vitality, risk or daring). Limited promotion is permitted in specific circumstances, subject to all applicable prohibitions, such as informational and brand-preference promotion when in a communication that is addressed and sent to a named individual who is at least 18; in a place where young persons are not permitted by law; by telecommunication, where the person responsible for the content of the promotion has taken reasonable steps to ensure it cannot be accessed by a young person; and in a prescribed place or done in a prescribed manner. However, promotion that is permitted in a place where young persons are not permitted by law may not be audible or visible from outside the place. In promotion authorized under subsection 17(6) of the Act (i.e., on t-shirts, hats, etc.), only one brand element may appear, and it can be no larger than 300 cm2 with a maximum text height of 4 cm within the brand element. The provision excludes promotion on anything associated with young persons, including anything in a public place frequented mainly by young persons (e.g. a public playground) and anything visible from such a place. Representations and associations that are prohibited on product packaging and labels are also prohibited in promotions, such as certain flavors in cannabis extracts; health or cosmetic benefits; energy value and amount of certain nutrients; special dietary requirements; and alcoholic beverages and tobacco and vaping products. These prohibitions and restrictions do not apply to prescription drugs containing cannabis or combination products. In TAG’s next newsletter, we will cover the remainder of the regulation, which is focused primarily on packaging and labeling and recordkeeping. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com