Standard Active Last Updated: Feb 19, 2025 Track Document
ASTM D8595-25

Standard Guide for Allergen Control in the Manufacturing of Orally Consumed Products Derived from Cannabis Sativa L Plants

Standard Guide for Allergen Control in the Manufacturing of Orally Consumed Products Derived from Cannabis Sativa L Plants D8595-25 ASTM|D8595-25|en-US Standard Guide for Allergen Control in the Manufacturing of Orally Consumed Products Derived from Cannabis Sativa L Plants Standard new BOS Vol. 15.10 Committee D37
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Significance and Use

5.1 Exposure to allergens in orally consumed products (such as foods, beverages, and dietary supplements) can cause reactions ranging from mild rashes to anaphylaxis and death in sensitive individuals. Because there are currently no treatments that can cure these allergies, the only risk mitigation strategy available to sensitive consumers is strict avoidance.

5.2 Effective avoidance is only possible when manufacturers provide clear, accurate, and complete information on the presence of allergens in each product. Allergen controls allow manufacturers to do this by ensuring that all intended allergens are declared on product labels and that no unintended allergens are present because of cross-contact.

5.3 Allergen controls differ from the procedures used to prevent the presence of toxic chemicals, such as extraction solvents, pesticides, or mycotoxins in products because allergens are desirable ingredients in many orally consumed products. Allergens are often used at high levels and can be expected to be common in the ingredient supply chain.

5.4 Therefore, it is important for each facility to develop and implement an allergen control plan that is specific to that facility and its products.

5.5 Because the allergen control principles in this guide integrate national and international regulatory requirements, Codex Alimentarius Commission standards, and industry guidance for traditional foods and dietary supplements, they apply to the manufacture of all products that contain ingredients derived from Cannabis sativa plants, regardless of their regulatory status or cannabinoid content.

Scope

1.1 This guide applies to all orally consumed products derived from Cannabis sativa L plants.

1.2 Units—The values stated in SI units are to be regarded as the standard. This standard does not include other units of measurement.

1.3 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.

1.4 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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Details
Book of Standards Volume: 15.10
Developed by Subcommittee: D37.02
Pages: 6
DOI: 10.1520/D8595-25