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ASTM D8441/D8441M-22

(Specification)

Standard Specification for International Symbol for Identifying Consumer Products Containing Intoxicating Cannabinoids

Standard Specification for International Symbol for Identifying Consumer Products Containing Intoxicating Cannabinoids

SCOPE
1.1 This specification establishes an international symbol applicable to all products containing intoxicating cannabinoids at a quantity or concentration sufficient to have a warning deemed necessary by the authority having jurisdiction (AHJ).  
1.2 This specification shall apply to all finished products that are intended for consumer use, which includes topical use, ingestion, inhalation, and any/all other methods of adsorption on or in the body of a human or animal.  
1.3 This specification provides uniformity in identifying potential health and safety hazards associated with exposure to a substance that may cause intoxicating (that is, mind or consciousness altering, or both) effects.  
1.4 This specification seeks to ensure visual clarity and consistency, which results in improvement of recognition and comprehension for the end user.  
1.5 Units—The values stated in either SI units or inch-pound 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.  
1.6 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.  
1.7 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.

General Information

Status
Published
Publication Date
31-Jan-2022
ICS
11.120.99 - Other standards related to pharmaceutics
Technical Committee
D37 - Cannabis
Drafting Committee
D37.04 - Processing and Handling
Current Stage
Ref Project

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ASTM D8441/D8441M-22 - Standard Specification for International Symbol for Identifying Consumer Products Containing Intoxicating CannabinoidsASTM D8441/D8441M-22 - Standard Specification for International Symbol for Identifying Consumer Products Containing Intoxicating Cannabinoids
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ASTM D8441/D8441M-22 - Standard Specification for International Symbol for Identifying Consumer Products Containing Intoxicating 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: D8441/D8441M −22
Standard Specification for
International Symbol for Identifying Consumer Products
1
Containing Intoxicating Cannabinoids
This standard is issued under the fixed designation D8441/D8441M; 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 2. Referenced Documents
2
2.1 ASTM Standards:
1.1 This specification establishes an international symbol
D8270Terminology Relating to Cannabis
applicable to all products containing intoxicating cannabinoids
3
at a quantity or concentration sufficient to have a warning
2.2 ANSI Standard:
deemed necessary by the authority having jurisdiction (AHJ).
ANSI Z535.1-2017Safety Colors
4
2.3 ICD Standard:
1.2 This specification shall apply to all finished products
ICD-10Classification of Mental and Behavioural Disorders;
thatareintendedforconsumeruse,whichincludestopicaluse,
clinical descriptions and diagnostic guidelines
ingestion, inhalation, and any/all other methods of adsorption
5
on or in the body of a human or animal.
2.4 ISO Standard:
ISO 3864-1:2011 Graphical symbols—Safety colours and
1.3 This specification provides uniformity in identifying
safety signs—Part 1: Design principles for safety signs
potential health and safety hazards associated with exposure to
and safety markings
a substance that may cause intoxicating (that is, mind or
ISO 3864-2:2016 Graphical symbols—Safety colors and
consciousness altering, or both) effects.
safety signs—Part 2: Design principles for product safety
1.4 This specification seeks to ensure visual clarity and
labels
consistency, which results in improvement of recognition and ISO 3864-3:2012Graphical symbols—Safety colors and
comprehension for the end user. safety signs—Part 3: Design principles for graphical
symbols for use in safety signs
1.5 Units—The values stated in either SI units or inch-
pound units are to be regarded separately as standard. The
3. Terminology
values stated in each system are not necessarily exact equiva-
3.1 Definitions:
lents; therefore, to ensure conformance with the standard, each
3.1.1 acute intoxication, n—transient condition following
system shall be used independently of the other, and values
the administration of alcohol or other psychoactive substance
from the two systems shall not be combined.
resulting in disturbances in level of consciousness, cognition,
1.6 This standard does not purport to address all of the
perception, affect or behavior, or other psychophysiological
safety concerns, if any, associated with its use. It is the
functions and responses. ICD-10
responsibility of the user of this standard to establish appro-
3.1.2 intoxicating cannabinoid(s), n—cannabinoids that
priate safety, health, and environmental practices and deter-
typically elicit acute intoxication.
mine the applicability of regulatory limitations prior to use.
3.1.2.1 Discussion—See Annex A1 for examples of intoxi-
1.7 This international standard was developed in accor-
cating cannabinoids.
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
mendations issued by the World Trade Organization Technical
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Barriers to Trade (TBT) Committee.
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org.
1 4
This specification is under the jurisdiction of ASTM Committee D37 on World Health Organization (WHO), International Statistical Classification of
CannabisandisthedirectresponsibilityofSubcommitteeD37.04onProcessingand Diseases and Related Health Problems (ICD).
5
Handling. Available from International Organization for Standardization (ISO), ISO
Current edition approved Feb. 1, 2022. Published February 2022. DOI: 10.1520/ Central Secretariat, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva,
D8441_D8441M-22. Switzerland, https://www.iso.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
D8441/D8441M − 22
3.1.3 non-intoxicating cannabinoid(s), n—cannabinoidsthat sisting of a black-bo
...

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ASTM D8270-23b(Terminology)
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1.1 This terminology is a compilation of definitions of technical terms used in the cannabis industry. Terms that are generally understood or adequately defined in other readily available sources are not included.  
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4.1 Standards and practices for assuring safety, quality, and weight stabilization during key steps of the cannabis/hemp flowers’ sojourn are in order.  
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1.1 Specification D8450 specifies the environmental conditions, such as temperature, humidity, and lighting under which the cured, dry, cannabis/hemp flowers in fresh format intended for human use are to be packaged to assure the safety, quality, and weight stabilization of the packaged flower. This guide suggests means by which the packager of cannabis/hemp can meet Specification D8450.  
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1.1 This test method allows for the concentration determination of the pesticides listed in Table 1 and shall apply to any dried raw material from a cannabis plant (Note 1, Note 2) regardless of the type of cannabis plant from which it was derived (1, 2).2 For the sake of brevity, the term “cannabis” shall be used from now on to refer to any type of cannabis plant including those which can be classified as hemp. The procedure includes sub-sampling a ground, homogenous sample, liquid-solid extraction with acetonitrile:acetic acid (100:1, v:v), solid phase extraction with C18 SPE media, dilution in 3 mM ammonium formate in water with 0.1 % formic acid and 3 mM ammonium formate in methanol with 0.02 % formic acid in a 20:80 ratio (v:v) and analysis by LC-MS/MS. This procedure encompasses the entire process from sample preparation to analyte quantitation encompassing a range of 0.005 µg/g to 0.500 µg/g.  
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5.1 The analysis and reporting of cannabinoid content in cannabis and hemp is required to address human health and safety concerns, satisfy testing and labeling requirements, and meet the regulatory guidelines of various jurisdictions. This test method is useful in providing quantitative results for up to seventeen cannabinoids in dried cannabis and hemp raw material samples.
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1.1 This test method allows for the concentration determination of the cannabinoids listed in Table 1, and shall apply to any dried raw material from a cannabis plant (Note 1, Note 2) regardless of the type of cannabis plant from which it was derived.2 For the sake of brevity, the term “cannabis” shall be used from now on to refer to any type of cannabis plant including those that can be classified as hemp. The procedure includes sub-sampling a ground, homogeneous sample, extraction with methanol:water (80:20, v:v),3,4 dilution in methanol and analysis by liquid chromatography tandem mass spectrometry (LC-MS/MS). The method allows for a wide-range of sample concentrations to be determined by using a 1000-fold calibration range and the option to perform multiple levels of sample dilution. The calibration curve is prepared in methanol over a range of 10 ng/mL to 10 000 ng/mL for all seventeen cannabinoids, or a subset of cannabinoids if desired, while the sample extracts are diluted in methanol into the calibration range.3,4,5 For example, a 1/500 dilution of sample extracts allows concentration determination over a range of 0.5 mg/g to 500 mg/g in cannabis. The method was validated with quality control samples prepared in methanol, a candidate certified reference material (CRM), and repeat extraction and analysis of cannabinoid samples.3  
Note 1: For this test method, dried raw material from a cannabis plant includes one or more of inflorescence, leaves, or stems.
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5.1 The sample preparation procedure for comminution impacts other downstream processes such as extraction and sonication, which ultimately affects the total analytical error (TAE) and measurement uncertainty.  
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SCOPE
1.1 In this guide, the basic steps in obtaining a test portion sample of either dried cannabis/hemp inflorescence are outlined.  
1.2 Sample preparation depends on many factors including moisture (dryness) of the sample, the analyte to be measured, the concentrations/amounts, and the test method's precision and accuracy requirements. In this case, dried cannabis or hemp plant material require particle size reduction-comminution from a representative sample of which the final analytical testing portion is determined by the employed testing method. Local regulatory guidelines often dictate both the representative sample that is taken from the bulk material (harvest batch) and the final mass of the test portion (for example  
1.3 This guide will not purport to meet every local and state jurisdiction since different regulatory requirements vary; the local/state requirements are at the discretion of the user to follow and interpret.  
1.4 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.  
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5.1 As patient use of cannabis and hemp for medical purposes increases and medical professionals are increasingly called upon to provide medical advice, the following requirements and expectations within the medical profession are increasingly significant, requiring:  
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5.2.1 Provide a general overview of the BoK required for the professions listed in Section 7; and  
5.2.2 Provide recommendations to form the foundation for training and subsequent recognition/certificate systems that enable consumers, employers, organizational management, government agencies, and others who rely upon medical professionals to distinguish between qualified and non-qualified workers.  
5.2.3 Recommend requirements that agencies can use to develop and document the specific criteria used for training or certificate programs.  
5.3 Users of this guide shall document deviations from the recommended requirements to inform their clients of the criteria applied in either the training or the certificate programs offered. As the cannabis and hemp industries and medical guidelines mature, this guide will be updated to reflect current thinking and requirements.  
5.4 The Bok elements are applicable to certificate programs, while the BoK, experiential and educational elements are applicable to certification process requirements.
SCOPE
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Standard Test Method for Analysis of Multiple Elements in Cannabis Matrices by Inductively Coupled Plasma Mass Spectrometry (ICP-MS)

SIGNIFICANCE AND USE
5.1 Medical and/or recreational marijuana (cannabis) has been legalized for adult use in many countries and states within the USA (5). Many jurisdictions that permit the use of medicinal and recreational marijuana require testing of cannabis and associated products to ensure safety from contaminants, especially the toxic “big four” elements such as As, Cd, Hg, and Pb (6), and other metals worthy of consideration (6). These heavy metals can accumulate in plants grown in polluted soils or contamination can occur during the manufacturing process (7). In addition to ensuring product safety, the analysis of mineral and other trace elements is required for labeling purposes when these products are sold as nutritional supplements. Trace element analysis of plant and nutritional supplement materials is a well-established application (8). Following acidic digestion to break down the plant-based samples' primary components, ICP-MS is often used for quantitative analysis because of its multi-element capability, high sensitivity, speed, robustness, and wide dynamic range.  
5.2 This test method covers the rapid determination of multiple elements in cannabis sample digests. The elements include the priority toxic elements (As, Cd, Hg, and Pb), as well as elements required by some states and elements of interest in the cannabis community (V, Cr, Cu, Zn, Sb, Ba, Se, Ag, Na, Al, K, Mn, Fe, Co, Ni, Mo, Tl, Th, and U). Irrespective of the number of elements being measured, test times are approximately a few minutes per test specimen, and detectability for most elements is in the low- to sub-ppb range.
SCOPE
1.1 This test method uses inductively coupled plasma mass spectrometry (ICP-MS) to determine multiple trace elements in cannabis and cannabis-related matrices following sample preparation using microwave-assisted acid digestion. This test method is applicable to the quantification of trace levels of elements in dried plant materials, concentrates, oils, extracts, tinctures of cannabis and cannabis-related products. Other matrices may be added provided that the lab validates the extra matrices using Practice D8282. Details are provided on the validation of both the sample preparation procedure and analytical method using certified reference materials (CRMs) and validation of the analytical method using spike recovery testing of several cannabis based samples.  
1.2 This test method should be used by analysts experienced in the use of microwave digestion and ICP-MS, matrix interferences, and procedures for their correction or reduction, and should only be used by personnel trained in the handling, preparation, and analysis of samples for the determination of trace elements in cannabis and cannabis products (1).2 This test method was developed using a single quadrupole ICP-MS equipped with a collision/reaction cell (CRC) that can be pressurized with helium (He) gas for the removal of polyatomic interferences using kinetic energy discrimination (KED). This test method can also be run using a triple quadrupole or “tandem” mass spectrometer (MS/MS) ICP-MS instrument, which is fitted with CRC technology. The ICP-MS method accounts for polyatomic interferences, which are the most common spectral overlaps in ICP-MS, isobaric interferences, and any potential doubly-charged ion interferences (M2+) that may arise from the presence of rare earth elements (REEs) in the samples, as the REE2+ ion interferences can affect the accuracy of the measurement of arsenic (As) and selenium (Se) in the samples. Table 1 lists elements for which the test method applies along with recommended analytical masses, and secondary masses for some elements. The priority toxic elements arsenic (As), cadmium (Cd), mercury (Hg), and lead (Pb), also sometimes referred to as the “big four” toxic trace elements are listed separately because of their toxicity, as discussed in 5.1.  
1.3 Certified reference materials (CRMs) should be matrix matc...

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