Designation: WK60446 XX

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1 This document is not an ASTM stard; it is under consideration within an ASTM technical committee but has not received all approvals required to become an ASTM stard. You agree not to reproduce or circulate or quote, in whole or in part, this document outside of ASTM Committee/Society activities, or submit it to any other organization or stards bodies (whether national, international, or other) except with the approval of the Chairman of the Committee having jurisdiction the written authorization of the President of the Society. If you do not agree with these conditions please immediately destroy all copies of the document. Copyright ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA All Rights Reserved. Designation: WK60446 XX Date: September 4, 2018 ITEM 2 To: Subcommittee D37.04 And D37 Main Concurrent Ballot Item ITEM 12 Tech Contact: Andy Heins; heins@allpack.com ; Work Item #: Ballot Action: Ballot History: WK60446 New Stard Guide 3 rd Subcommittee Ballot Rationale: Stards regulations specific to packaging labeling in various jurisdictions (regardless of country, county, state/province or local municipality) vary widely change frequently. This lack of consistency the frequency of change causes substantial confusion, waste additional cost to both manufacturers, ultimately to the consumer. This Guide is intended to be a resource for all regulatory agencies policy administrators, shall contribute substantially to the promotion of public health safety with regard to the consumption of cannabis flowers, resins /or the products derived therein. Stard Guide for Packaging Labeling of Consumer Resin Cannabis Products for Sale to Adult Consumers, Legally Authorized Medical Users Caregivers in a Business-to-Consumer Retail Environment (Retailers) 1 This stard is issued under the fixed designation WK60446; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last re-approval. A superscript epsilon (ε) indicates an editorial change since the last revision or reapproval. 1. Scope 1.1 This guide is for the packaging labeling of cannabis flowers, resins, preparations derived therefrom for sale to adult consumers, legally authorized medical users caregivers in a business-to-consumer/patient/caregiver retail environment other legal distribution channels. This includes labeling of products, regardless of packaging format, that will be purchased by adults in retail dispensaries, pharmacies, or other distribution methods (e.g., postal shipment). 1.2 This guide does not address packaging or labeling specific to non-consumer facing transactions (e.g., products packaged for transfer between business entities, including growers, processors, manufacturers, wholesalers, retailers). 1.3 This guide incorporates relevant materials previously published in other industry resources such as ASTM Committees D10 F02, Foundation of Cannabis Unified Stards (FOCUS), American Herbal Products Association (AHPA), Occupational Safety Health Administration (OSHA), various sanctioned working group findings publications (e.g., Council on Responsible Cannabis Regulation (CRCR), National Cannabis Industry Association (NCIA), etc.). 1.4 This international stard was developed in accordance with internationally recognized principles on stardization established in the Decision on Principles for the Development of International Stards, Guides Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. 2. Referenced Documents 2.1 ASTM Stards: 2 D3475 Classification of Child-Resistant Packages 1 This guide is under the jurisdiction of ASTM Committee D37 on Cannabis is the direct responsibility of Subcommittee D37.04 on Processing Hling. Current edition approved. Published XXXX. DOI: /XXXX-XX 2 For referenced ASTM stards, visit the ASTM website, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Stards volume information, refer to the stard's Document Summary page on the ASTM website. 1

2 F2097 Guide for Design Evaluation of Primary Flexible Packaging for Medical Products 2.2 Other Stards Related Organizations: Foundation of Cannabis Unified Stards (FOCUS) National Association of Cannabis Businesses (NACB) American Herbal Products Association (AHPA) Council on Responsible Cannabis Regulation (CRCR) National Cannabis Industry Association (NCIA) 2.3 Statutes Rules Review: California Medicinal Adult Use Cannabis Regulation Safety Act (MAUCRSA) Colorado Department of Revenue Marijuana Enforcement Division Connecticut Department of Consumer Protection Health Canada Proposed Approach to the Regulation of Cannabis Illinois Department of Agriculture Licensing & Regulations Section Oregon Liquor Control Commission (OLCC) Massachusetts Cannabis Control Commission Nevada LCB/Department of Taxation State of Washington WAC Terminology 3.1 Definitions: cannabis/rresin cannabis products, n any product containing or comprised of cannabis flowers /or resins includes, but is not limited to, the cannabis flowers resins themselves, extracts/concentrates/derivatives thereof, preparations therefrom child-resistant/senior friendly packaging, n special packaging that is significantly difficult for children under five years of age to open, yet not difficult for seniors (65 years of age older) to use properly. See ASTM container/immediate container, n sealed, hard, or soft-bodied receptacle in which a cannabis item is placed exit package, n opaque bag or other similar opaque covering provided at the point of sale secondary packaging, n packaging in addition to the immediate container, if applicable, that is the outermost layer visible to the consumer at the point of sale local jurisdiction/authorities having jurisdiction, n the area for which the regulation(s) apply, such as federal, state/province, county, or local municipality opaque, n packaging does not allow the product to be seen without opening the packaging material semi-opaque, n packaging that may allow light but not detailed images to pass through; syn. semi-transparent; translucent resealable, n immediate container maintains its child-resistant effectiveness for multiple openings shipping container, n sealed, hard or soft-bodied container used to transport multiple consumer packages security shipping container, n lockable, hard-sided container with a lid or other enclosure that can be secured in place for purposes of transporting cannabis products to from licensed cannabis businesses, including but not limited to wholesaler, cultivator, processor, manufacturer, retailer, research/testing facilities tamper evident, a a seal or closure of a package designed to reveal any prior interference with the contents universal symbol, n a graphic representation, as defined by the local jurisdiction, indicating a warning of potentially harmful substances /or effects of improper use variable weight consumer resin cannabis products, n product which is apportioned at the point of sale by the retail operator priced based on the weight measure (typically using the kilogram (kg) as the proper SI unit). 4. Significance Use 4.1 This guide provides manufacturers, wholesalers, retailers with guidance on how to package label consumer resin cannabis products, based on their intended use, in a manner that prevents contamination promotes prevention of 2

3 accidental or improper consumption. The guide recommends packaging types, terminology, nomenclature, graphics symbols that enable consumers to determine product type, strain, potency, concentration, dosage, expiration date, such that informed decisions can be made. 5. Packaging 5.1 General Provisions for All Forms of Consumer Resin Cannabis Products (e.g., flowers, resins products derived from them), for Retail or other legal distribution channel All consumer resin cannabis products should be placed in an immediate container that is opaque, tamper-evident child-resistant prior to the time of transfer to a retail operation or distribution/fulfillment center, except as specifically identified in this guide. Containers shouldall be tested certified by a properly accredited recognized authority, using commonly accepted protocols such as those defined with authorities having jurisdiction (e.g., The United States Code of Federal Regulations (CFR), 16 CFR 1700, Poison Prevention Act of 1970, 1995 seq., Title ). The immediate secondary containers shallshould not expose the cannabis products to any toxic or harmful contaminants. See ASTM D A film wrapper used to seal product for freshness/shelf life or to prevent odor leaching may be used in addition to but not in lieu of the immediate container : Non-edible cannabis flower product may be placed in an immediate container that is transparent All resin cannabis products should be placed in an opaque or semi-opaque exit bag at the point of sale, prior to transfer to a consumer/patient/licensed caregiver, such that it does not exceed the legal maximum sales limit established by the local jurisdiction If the consumer resin cannabis product s immediate container is child-resistant, then neither the secondary container nor the exit bag must need be child-resistant If the consumer resin cannabis product s immediate container is not required to be child-resistant as specified in 5.2, or if there is not yet an approved child-resistant container available in the marketplace for the approved product form, then the container should be placed in an opaque, child-resistant exit bag at the point of sale, prior to transfer to a consumer/patient/licensed caregiver, if applicable Variable weight consumer resin cannabis products should be placed in an opaque child-resistant container or exit package at the point of sale, prior to transfer to a consumer/patient/designated caregiver Consumer resin cannabis product containers housing multiple servings of active THC product must maintain its child-resistant effectiveness for multiple openings consistent with, at minimum, the number of servings in the container Authorities having jurisdiction may, with required documentation provided by a licensed caregiver, make exceptions to child-resistant packaging requirements for elderly /or hicapped persons Consumer resin cannabis packaging manufacturers should certify maintain proper documentation (e.g., a General Certificate of Conformity) for each form of packaging containing resin cannabis products. Consumer resin cannabis retail operations distribution/fulfillment centers placing product in child-resistant containers /or exit bags should maintain proper child-resistant certification documentation for all such containers exit bags Stard classifications of child-resistant packaging may be referenced, including Classification D3475 Guide F Additional Packaging Guidelines by Product Form Single Serve Ingestible Consumer Resin Cannabis A single-serve ingestible solid or liquid consumable resin cannabis product containing no more than the maximum legally permissible amount of active THC (as defined by local jurisdiction) must should be placed in a child-resistant opaque container. Plastic packaging used as containers for solid or liquid ingestible consumer resin cannabis products should be at least no less than four one-thousths of an inch in thickness (4 mils) be heat sealed with no easy-open tab,dimple, corner or flap as to make it difficult for a child to open as a tamperproof measure. Other packaging substrates such as glass, metal other non-leaching food-grade materials, including paperboard, may be used Multi-Serve Solid Ingestible Consumer Resin Cannabis products shouldmust either: Be separated into child-resistant opaque internal containers of no more than the maximum legally permissible single serve amount of active THC (as defined by local jurisdiction), with the larger external packaging not required to be child-resistant, or Be placed in a child-resistant opaque container that maintains its child-resistant effectiveness for multiple openings be demarcated into separate or easily separable single servings, with each serving containing no more than the maximum 3

4 legal amount of active THC (as defined by local jurisdiction) Multi-Serve Liquid Ingestible Consumer Resin Products Items containing more than a single serving of the maximum legally permissible amount of active THC (as defined by local jurisdiction) mustshould be placed in a child-resistant container that includes a measuring component that cannot be separated from the cap or container, or a volumetrically accurate pumping device enabling a user to pour increments not to exceed the equivalent of a single serving of active THC. Hash marks on the container are not sufficient Concentrates Refillable or Disposable Cartridges Vaporizer Pens A sealed refillable or disposable vaporizer cartridge or disposable vaporizer pen need not itself be child-resistant but must be placed in a child-resistant container prior to transfer to a consumer/patient/designated caregiver Immature Plants immature plants shallshould be placed into a receptacle. The receptacle may, but is not required to, be child-resistant may not require use of a child-resistant exit package Viable Resin Cannabis Seeds, Loose Flower, Trim The container may, but is not required to, be child-resistant should keep the product dry. Any immediate container that is not child-resistant shallshould be placed into an opaque child-resistant secondary container or exit package at the point of transfer to a consumer/patient/designated caregiver. 6. Labeling 6.1 General Provisions The following requirements apply to labels affixed to the immediate container /or any secondary containers of all retail consumer resin cannabis products. The immediate any secondary container should have a label with all information required by the local jurisdiction. Any intermediary packaging between the immediate secondary container may but is not required to be labeled Font Size Language Labeling text on the immediate any secondary container should be no smaller than a 6-point font (or 1 / 16 inch) should be printed in the officially recognized language(s) of the country or province Unobstructed Conspicuous Labeling text on the immediate any secondary container must should be unobstructed conspicuous. A cannabis operation may affix multiple labels to a container provided none of the information suggested by this guide or by the local authority is obstructed. For example, not by means of limitation, labels may be accordion, expable, extendable, or layered to permit labeling of small containers Health Claims/Benefits The label(s) on the immediate any secondary container asshould not make any claims regarding health or physical benefits to the consumer except if as approved by governing food drug agencies within the local jurisdiction, nor shallshall it make any false or misleading claims/statements Appeal to Children Labels any graphics on the immediate any secondary container should not be designed to appeal to children or target individuals under the legal age as defined by the local jurisdiction. Use of cartoon characters or similar images are prohibited, as is the use of the word cy or cies Use of Trademarks No immediate or secondary container should be intentionally or knowingly labeled so as to cause a reasonable consumer confusion as to whether the retail consumer resin cannabis products are a trademarked, or labeled in a manner that violates any applicable trademark law or regulation Exit Bags The exit package may not be required to be labeled but may include the retail cannabis store s identity statement /or stardized graphic symbol. 6.2 Labeling Guidelines by Product Form See Table 1. 4

5 TABLE 1 Labeling Guidelines by Product Form Labeling Requirements Prior to Transfer to Consumers, Patients, Caregivers All Flower Trim Viable Seed Immature Plants Extracts / Concentrates Edibles other than Edible Pre-Roll, Blunt Topical Suppository Transdermal All required labels are affixed to products prior to transfer to retail store X X X X X X X All required labels are affixed to products prior to transfer to consumer (affixed at retail store) X X Item Identification Use of common or usual name is recommended (e.g., "cannabis", "marijuana"); Identity statements should clearly identify the resin cannabis product. Examples: cannabis flowers, cannabis resins, resin cannabis gummy. 5

6 Labeling Requirements Prior to Transfer to Consumers, Patients, Caregivers Required License Numbers Information Product Harvest Production Batch/Lot Numbers; Date of Manufacture Net Contents Serving Size Information (as measured prior to placement in container) Universal Symbol Potency Statement Date of Sale All License number, physical address web address of: (1) cannabis cultivation facility where grown (affixed to immediate any secondary container); (2) cannabis product manufacturing facility where produced (affixed to immediate any secondary container); (3) retail store where sold (affixed to immediate any secondary container) Must be included, as defined by product form Net quantity, stated in metrics common to local jurisdiction (e.g., ounces, milligrams, grams, etc.) If local jurisdiction requires; recommend 1 /2 1 /2 in. with statement "Contains MarijuanaCannabis. Keep Away from Children" Stated in percentages or milligrams, by product form; recommend in bold font highlighted in appropriate manner The retail cannabis operation or fulfillment center should shall affix date of sale to the consumer on the outermost container (immediate or secondary) Flower Trim Harvest Number Weight Projected % of effective total THC CBD any other cannabinoi d by weight or by volume Viable Seeds Immature Plants Date of Cloning / Harvest Number of Seeds per Container Projected % of total THC CBD any other cannabinoid as required by the local authority per seed/plant Extracts / Concentrates Net Weight or Volume Total THC CBD any other cannabinoid as required by the local authority by weight or volume, or number of milligrams of total THC CBD any other cannabinoid as required by the local authority per container. Edibles other than Edible Amount of total THC CBD any other cannabinoid as required by the local authority, expressed in milligrams per manufacturer specified serving/servings per container Pre-Roll, Blunt Production Number Production Date Topical Suppository Weight, Volume, or Number of Servings/Units Amount of total THC CBD any other cannabinoid as required by the local authority Transdermal Amount of total THC CBD any other cannabinoid as required by the local authority 6

7 Labeling Requirements Prior to Transfer to Consumers, Patients, Caregivers Expiration or Use By Date; Refrigerate (if necessary) All Products capable of supporting the rapid progressive growth of infectious, toxigenic, or spoilage microorganisms must should be labeled with a "Use by" or "Freeze by" date Flower Trim Viable Seeds Immature Plants Extracts / Concentrates Edibles other than Edible Pre-Roll, Blunt Topical Suppository Transdermal Yes Yes Yes Yes Yes Yes Yes Yes Solvent List Yes Yes Yes Yes Yes Yes Yes Ingredient List Warning Statements Contaminant Testing Nutritional Fact Panel Ingredient list by common or usual name. Major allergens a listing of fertilizers, nutrients, additives, pesticides integrated pest management chemicals should be listed, including major allergens in accordance with local jurisdiction (e.g., Food Allergen Labeling Consumer Protection Act of 2004, 21 U.S.C. 343) On immediate any secondary container with stard graphic or symbol /or language: (1) "This product contains THC, Cannabis or Marijuana. (2) "There may be long term physical or mental health risks from use of cannabis including additional risks for women who are or may become pregnant or breast feeding. Use of cannabis may impair your ability to drive a car or operate machinery."; (3) "For Medical Use Only" (if applicable) A generic statement of compliance with (local) matory testing. include list of fertilizers, nutrients, additives, pesticides, integrated pest management chemicals used include list of fertilizers, nutrients, additives, pesticides, integrated pest management chemicals used include list of fertilizers, nutrients, additives, pesticides, integrated pest management chemicals used Inclusion of Activation Time: "The intoxicating effects of this product may be delayed by up to 4 hours." In compliance with local jurisdiction nutritional labeling requirements for food organic products (e.g., labeling in accordance with the same type of food or potable liquid when the food/potable liquid product does not contain Inclusion of Activation Time: "The intoxicatin g effects of this product may be delayed by up to 4 hours." 7

8 cannabis) 8

9 Labeling Requirements Prior to Transfer to Consumers, Patients, Caregivers All Flower Trim Viable Seeds Immature Plants Extracts / Concentrates Edibles other than Edible Pre-Roll, Blunt Topical Suppository Transdermal Instructions for Use Intended Use Labels (must include all intended uses if the product form can be used in different ways) This product for use only by adults age (insert legal age as defined by local jurisdiction) or older; For Medical Use only by Authorized patients (if applicable) INHALED PRODUCT INHALED Solvent - based; Water-based; Heat/Pressur e-based; Vaporizer Cartridge / Vaporizer Pen; FOR ORAL CON- SUMP- TION For OROMUCOSAL DELIVERY OR INGESTION INHALED FOR USE ON SKIN OR BODY ONLY DO NOT INGEST FOR COLORECTAL / VAGINAL APPLICATION ONLY; DO NOT INGEST FOR USE ON SKIN OR BODY ONLY DO NOT INGEST False Misleading Statements Cultivators, Processors, Manufacturers, Retail Stores are prohibited from making false or misleading statements, including but not limited to health benefits, nutritional value, or cultivation processing methods. Identity Statements /or Stard Graphic Symbol for Cultivation, Processing, Manufacturing Facilities, Retail Store May include, but not required. 7. Keywords 7.1 cannabis; labeling; packaging ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentioned in this stard. Users of this stard are expressly advised that determination of the validity of any such patent rights, the risk of infringement of such rights, are entirely their own responsibility. This stard is subject to revision at any time by the responsible technical committee must be reviewed every five years if not revised, either reapproved or withdrawn. Your comments are invited either for revision of this stard or for additional stards should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of the responsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you should make your views known to the ASTM Committee on Stards, at the address shown below. This stard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA , United States. Individual reprints (single or multiple copies) of this stard may be obtained by contacting ASTM at the above address or at (phone), (fax), or service@astm.org ( ); or through the ASTM website ( Permission rights to photocopy the stard may also be secured from the Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923, Tel: (978) ; 9

Cannabis Labeling Requirements By State

Cannabis Labeling Requirements By State A Quick Reference Listing ALASKA Alaska s cannabis labeling and packaging guidelines include the following: 3 AAC 306.345. Packaging and labeling. (a) A retail marijuana