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现行 ASTM D8449-23
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Standard Specification for Label Content and Style, Format, Location, and Prominence of Elements for Consumer Products Containing Cannabinoids 含有大麻酚的消费品标签内容和样式、格式、位置和突出度的标准规范
发布日期: 2023-04-01
1.1 本规范应规定在成人或药用市场销售的含有大麻素的消费品的标签内容、样式和格式规范。 1.2 本规范应明确规定这些规范适用的产品类别。 1.3 本规范应适用于在成人或医药市场包装、分销和销售的所有含有大麻素的消费品,无论大麻素获取(来源)的方法如何。 1.4 本规范不适用于含有少于10 000 PPM(1 %) 总大麻素 2. ,其中,不超过3000 PPM(0.3 %) 应为总THC 3. . 1.5 本规范不适用于含量低于250的可摄入消费品 PPM(0。 025 %) 大麻素总量,其中不超过10 PPM(0.001 %) 应为总THC 4. . 1.6 本规范不应定义经批准的膳食补充剂、非处方药或含有大麻素的药物的标签规范。 1.7 本规范不应定义含有大麻素的非消费品的标签规范,如散装或在制品。 1.8 本规范不应定义标签材料、粘合剂、墨水或其他与标签内容或元素的样式、格式、位置和突出度无关的特征的设计特征。 1.9 如果本规范的各方面与管辖法规要求不同,应以两者中较严格的要求为准。 1.10 如果本规范的某些方面与管辖法规要求相冲突,则应优先考虑具有管辖权的机构。 1.11 单位- 以国际单位制或美国习惯单位表示的数值应单独视为标准。每个系统中规定的值不一定是精确的等效值;因此,为了确保符合标准,每个系统应独立使用,并且两个系统的值不应合并。 1.12 本标准并非旨在解决与其使用相关的所有安全问题(如有)。本标准的使用者有责任在使用前制定适当的安全、健康和环境实践,并确定监管限制的适用性。 1.13 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。
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 cannabinoids 2 , of which, no more than 3000 PPM (0.3 %) shall be total THC 3 . 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 THC 4 . 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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归口单位: D37.04
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