Standard Specification for Label Content and Style, Format, Location, and Prominence of Elements for Consumer Products Containing Cannabinoids

SCOPE
1.1 This specification shall define the label content and style and format specifications for consumer products containing cannabinoids sold in an adult-use or medicinal-use marketplace.  
1.2 This specification shall define clear product categories for which these specifications apply.  
1.3 This specification shall apply to all consumer products containing cannabinoids packaged, distributed, and sold in an adult-use or medicinal-use marketplace regardless of the methods of obtention (source) of the cannabinoids.  
1.4 This specification shall not apply to inhalable or topical consumer products containing less than 10 000 PPM (1 %) total cannabinoids2, of which, no more than 3000 PPM (0.3 %) shall be total THC3.  
1.5 This specification shall not apply to ingestible consumer products containing less than 250 PPM (0.025 %) total cannabinoids, of which, no more than 10 PPM (0.001 %) shall be total THC4.  
1.6 This specification shall not define the label specifications for approved dietary supplements, over-the-counter drugs, or pharmaceuticals containing cannabinoids.  
1.7 This specification shall not define the label specifications for non-consumer products containing cannabinoids such as bulk or in-process products.  
1.8 This specification shall not define the design characteristics for label material, adhesives, ink, or other features unrelated to label content or style, format, location, and prominence of elements.  
1.9 Where aspects of this specification differ from jurisdictional regulatory requirements, the stricter of the two shall take precedence.  
1.10 Where aspects of this specification conflict with jurisdictional regulatory requirements, the authority having jurisdiction shall take precedence.  
1.11 Units—The values stated in either SI units or US Customary units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.  
1.12 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.13 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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Status
Published
Publication Date
31-Mar-2023
Technical Committee
Current Stage
Ref Project

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ASTM D8449-23 - Standard Specification for Label Content and Style, Format, Location, and Prominence of Elements for Consumer Products Containing Cannabinoids
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: D8449 − 23
Standard Specification for
Label Content and Style, Format, Location, and Prominence
of Elements for Consumer Products Containing
1
Cannabinoids
This standard is issued under the fixed designation D8449; 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 reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.8 This specification shall not define the design character-
istics for label material, adhesives, ink, or other features
1.1 This specification shall define the label content and style
unrelated to label content or style, format, location, and
and format specifications for consumer products containing
prominence of elements.
cannabinoids sold in an adult-use or medicinal-use market-
1.9 Where aspects of this specification differ from jurisdic-
place.
tional regulatory requirements, the stricter of the two shall take
1.2 This specification shall define clear product categories
precedence.
for which these specifications apply.
1.10 Where aspects of this specification conflict with juris-
1.3 This specification shall apply to all consumer products
dictional regulatory requirements, the authority having juris-
containing cannabinoids packaged, distributed, and sold in an
diction shall take precedence.
adult-use or medicinal-use marketplace regardless of the meth-
1.11 Units—The values stated in either SI units or US
ods of obtention (source) of the cannabinoids.
Customary units are to be regarded separately as standard. The
1.4 This specification shall not apply to inhalable or topical
values stated in each system are not necessarily exact equiva-
consumer products containing less than 10 000 PPM (1 %)
lents; therefore, to ensure conformance with the standard, each
2
total cannabinoids , of which, no more than 3000 PPM (0.3 %)
system shall be used independently of the other, and values
3
shall be total THC .
from the two systems shall not be combined.
1.5 This specification shall not apply to ingestible consumer
1.12 This standard does not purport to address all of the
products containing less than 250 PPM (0.025 %) total
safety concerns, if any, associated with its use. It is the
cannabinoids, of which, no more than 10 PPM (0.001 %) shall
responsibility of the user of this standard to establish appro-
4
be total THC .
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
1.6 This specification shall not define the label specifica-
1.13 This international standard was developed in accor-
tions for approved dietary supplements, over-the-counter
dance with internationally recognized principles on standard-
drugs, or pharmaceuticals containing cannabinoids.
ization established in the Decision on Principles for the
1.7 This specification shall not define the label specifica-
Development of International Standards, Guides and Recom-
tions for non-consumer products containing cannabinoids such
mendations issued by the World Trade Organization Technical
as bulk or in-process products.
Barriers to Trade (TBT) Committee.
2. Referenced Documents
5
1
This specification is under the jurisdiction of ASTM Committee D37 on
2.1 ASTM Standards:
Cannabis and is the direct responsibility of Subcommittee D37.04 on Processing and
D8233 Guide for Packaging and Labeling of Consumer
Handling.
Resin Cannabis Products for Sale to Adult Consumers,
Current edition approved April 1, 2023. Published April 2023. DOI: 10.1520/
D8449-23. Legally Authorized Medical Users, and Caregivers in a
2
10 000 ppm is the limit that the US Pharmacopeia Cannabis Expert Panel has
Business-to-Consumer Retail Environment (Retailers)
recommended as the threshold for labeling cannabinoids. A reference is provided in
D8270 Terminology Relating to Cannabis
the Related Materials section of this specification.
3
3000 ppm for total THC (delta-9-THC) is based on the harmonized specifica-
tion for classifying Cannabis sativa L. plants as “hemp” in Europe and North and
5
South America. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4
10 ppm is the Health Canada limit for total THC (delta-9-THC) above which all contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
consumer products containing cannabinoids most be labeled with a Universal Standards volume information, refer to the standard’s Document Summary page on
Symbol. the ASTM website.
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