In last week’s newsletter, we discussed parts 5 and 6 (Good Production Practices and Products) of Canada’s newly published Amendments to the Cannabis Regulations, Final Regulations for New Cannabis Products: Edible Cannabis, Cannabis Extracts and Cannabis Topicals, which track closely with the requirements of its Safe Food for Canadians Regulations (SFCR). This week, we are providing an overview of the Packaging and Labelling (Part 7) and Recordkeeping (Part 11) requirements – which are more specific to the cannabis itself, thus track more closely with The Cannabis Act than did Parts 5 and 6. PART 7. PACKAGING AND LABELLING The packaging and labelling requirements, which apply to cannabis products for retail sale, are intended to restrict access of cannabis from the young, protect them and others from inducements to use cannabis, and help promote informed consumer choice and safe handling and storage. As such, the core plain packaging and labelling requirements of The Cannabis Act apply to all cannabis products, including that of the standardized cannabis symbol, health warning messages (as updated), THC and CBD quantity or concentration, and child-resistant packaging. All labeling requirements are effective October 17, 2019, for the new classes of cannabis, while existing cannabis classes of cannabis will have a 12-month transition period to adjust packaging and labelling. Dried and fresh cannabis and plants and seeds packaged and labelled in accordance with the current Regulations prior to the transition period can be sold indefinitely for medical purposes. THC/CBD Amounts. The Amendments modify labelling requirements for all classes of cannabis to standardize the THC and CBD amount descriptions and enable better comparison across products: For dried or fresh cannabis and extracts in discrete units intended to be inhaled and extracts not in discrete units, THC/CBD concentration must be expressed in milligrams per gram (mg/g). For extracts in discrete units not intended to be inhaled and for edibles, THC and CBD quantities must be expressed in milligrams (mg). For an extract in a container with an integrated dispensing mechanism, the label must express THC/CBD quantities in mg per activation. For cannabis topicals, THC/CBD can be expressed as mg/g (concentration) or mg (quantity). In all cases, the net weight of the product must be represented in grams, except beverages, for which volume is to be in millilitres. THC/CBD can be expressed in additional formats (e.g., by %) but not as replacements for the required labelling. All cannabis products (except dried cannabis and plants) must indicate its equivalency to grams of dried cannabis to enable consumers and law enforcement to determine compliance with the federal public possession limit of 30 grams of dried cannabis “or equivalent.” Products containing 10 ppm THC or less (e.g., pure CBD oil) need not have the standardized cannabis symbol on the product label. However, the brand element for these products must be sized at 25% or less of the principal display panel, and smaller than or equal to the area within the border of the label’s health warning message. Class-Specific Labelling. In addition to the requirement for company name and email address of the licensed cultivator or processor that manufactured the product (subject to specific size/format requirements on size and format, consistent with the plain packaging approach set out in the Regulations) on all product labels, the Amendments specify labelling requirements for each new class of cannabis and its accessories. These include: · Edible Cannabis. Consistent with requirements that apply to food under the Food and Drug Regulations (FDR), edibles must also include labeling of: – An ingredient list. – The common name of the cannabis product. – Any allergens, gluten, or sulphites. – A “durable life date” (e.g., best-before date) for those with a shelf life of 90 days or less. – A cannabis-specific Nutrition Facts Table (NFT). Like the standard format NFT for pre-packaged food, it must include energy value (i.e., calories) and amounts of the 12 core nutrients and % DV (as applicable) on a “per container” basis. (Specific requirements for the NFT will be published in the Directory of Nutrition Facts Table Formats for Edible Cannabis.) · Cannabis extracts and accessories. Labeling must include: – An ingredient list. – The common name or function of the cannabis product. – A list of allergens. – Intended use of the product (e.g., “for vaping”). – Quantity of THC/CBD per activation (in milligrams) for extracts in a container with an integrated dispensing mechanism. – The standardized cannabis symbol on any accessory that contains an extract intended to be inhaled that contains more than 10 ppm THC. The symbol must appear on the vaping device or cartridge and on the exterior surface of any wrapper that is in direct contact with a product that contains more than 10 ppm THC. · Cannabis topicals. Labeling must include: – An ingredient list. – The common name or function of the cannabis product. – A list of allergens. – Intended use of the product (e.g., “apply to skin”). Prohibited Labelling. Product packages and labels cannot include: · Health benefits, including those that are currently permitted on food. · Cosmetic benefits. · Association of the product or its brand with an alcoholic beverage, tobacco product, or vaping product. · Energy value and nutrient content beyond those permitted in the ingredient list and cannabis-specific NFT, including those permitted on food labels. · The representation of edible cannabis as meeting specific dietary requirements (e.g., suitable for a person with diabetes, as part of a low-calorie diet, etc.). · Representations associating a cannabis extract with certain flavors appealing to youth (such as desserts or confections), consistent with rules that apply to vaping products under the Tobacco and Vaping Products Act. · Packaging or labeling (or product appearance, shape or other attribute or function) that could appeal to young persons. · Testimonials or endorsements; depictions of a person, character or animal (real or fictional); association with a lifestyle; or any false, misleading, or deceptive information. Packaging. The current plain, child-resistant packaging requirements for all cannabis products are maintained, but the external surface of a metal can (e.g., beverage can) can be of the naturally occurring metallic colour and the exterior surface of the package need not have a matte finish (thus enabling the use of metal containers and peel-back and accordion labels). Additionally, for the new classes: · Food-grade packaging is required for the immediate container of edibles and for wrappers of edibles and extracts intended to be ingested. · Multi-packs of edibles and beverages are permitted, with total quantity of THC not exceeding 10 milligrams, and the total amount of cannabis not exceeding the public possession limit. The properties of the edible cannabis in each immediate container must be consistent, thereby precluding the sale of sampler packs. · The immediate container of non-discrete units of extracts must not enable it to be easily poured or drunk directly from the container. The immediate container of liquid extracts not intended to be inhaled that contain at least 10 mg of THC must have an integrated dispensing mechanism that dispenses no more than 10 mg, unless the extract is in discrete units (such as a capsule). · In addition to previously described THC quantity limits, extracts are limited to 7.5 grams maximum weight for those that contain ethyl alcohol and are intended to be ingested, and 90 mL for liquids. (This is in addition to the maximum package size of 7.5 g that applies to all cannabis concentrates.) · Cannabis and food cannot be co-packaged, nor can more than one class of cannabis. · Pressurized containers are permitted, allowing for carbonated beverages and cannabis accessories such as metered-dose inhalers. Labelling allowances for smaller containers. To accommodate smaller containers, the Amendments enable the use of expanded panels and alternative display formats for certain information when the immediate container is too small to accommodate all required information on the exterior. · Still required on the exterior are: the cannabis health warning messages, standardized cannabis symbol, and THC/CBD content. · The packaging date, recommended storage conditions, ingredient list, NFT, and any non-required information may be displayed on a panel. · Brand elements on the exterior must be smaller than or equal to the minimum size of the standardized cannabis symbol (or 7 points or smaller if the brand element is text only). · No brand elements are allowed on the panel. PART 11. RECORDKEEPING Recordkeeping requirements that apply to cannabis oil are amended to apply to edibles, extracts, and topicals. Additionally, each lot or batch of cannabis sold or exported must have documentation demonstrating that the cannabis meets the requirements of parts 5 and 6 (as opposed to just Part 5, as is currently the case). New requirements mandate that records also be kept of: · Ingredients used in production, including the: – Name and business address of the person who supplied the ingredient, if applicable. – Date the ingredient was obtained or produced by the licence holder. – Description of the ingredient, including its name (or chemical name, common name, international nomenclature cosmetic ingredient [INCI] name, and chemical abstracts service [CAS] registry number). – Lot code or other unique identifier, if applicable. · The purpose of each ingredient in extracts (e.g. carrier substance, flavouring agent), and description of the flavor, if applicable. · Every investigation undertaken by a QAP, including any proactive investigation of a possible risk of injury to human health or in response to a cannabis quality complaint, and any measures taken in response. · Any information obtained through testing that relates to the phytocannabinoid and terpene content of the cannabis product (for all classes except plants and seeds). This is in addition to current requirements for quantity or concentration of THC, THCA, CBD, and CBDA records. These records must be kept for a period of two years, consistent with the retention periods for most existing recordkeeping requirements. Adverse reaction reports must be kept for 25 years. As mentioned in our last newsletter summary, it is evident that the Canadian Government has taken a thoughtful and comprehensive approach to cannabis regulation. We urge the U.S. FDA to move in haste to address what was termed many times at the recent public meeting as “The Wild Wild West.” 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