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Standard Guide for Allergen Control in the Manufacturing of Orally Consumed Products Derived from <emph type="ital">Cannabis Sativa</emph> L Plants 源自<emph type="ital">大麻</emph>L植物的口服产品制造中过敏原控制的标准指南
发布日期: 2025-02-01
1.1 本指南适用于源自以下产品的所有口服产品 大麻 L植物。 1.2 单位- 以SI单位表示的值应被视为标准。本标准不包括其他计量单位。 1.3 本标准并不旨在解决与其使用相关的所有安全性问题(如果有)。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践并确定法规限制的适用性。 1.4 本国际标准是根据世界贸易组织技术性贸易壁垒(TBT)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。======意义和用途====== 5.1 暴露于口服产品(如食品、饮料和膳食补充剂)中的过敏原可导致敏感个体的反应,从轻度皮疹到过敏反应和死亡。因为目前没有可以治愈这些过敏的治疗方法,敏感消费者唯一可用的风险缓解策略是严格避免。 5.2 只有当制造商提供关于每种产品中过敏原存在的清晰、准确和完整的信息时,有效的避免才是可能的。过敏原控制允许制造商通过确保所有预期过敏原都在产品标签上声明,并且不存在因交叉接触而导致的意外过敏原来做到这一点。 5.3 过敏原控制不同于用于防止产品中有毒化学物质如提取溶剂、杀虫剂或真菌毒素存在的程序,因为过敏原是许多口服消费产品中的理想成分。过敏原通常以高水平使用,预计在成分供应链中很常见。 5.4 因此,每个工厂制定和实施针对该工厂及其产品的过敏原控制计划非常重要。 5.5 由于本指南中的过敏原控制原则整合了国家和国际监管要求、食品法典委员会标准以及传统食品和膳食补充剂的行业指南,因此它们适用于所有含有源自 大麻 植物,无论其监管状况或大麻素含量如何。
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. ====== 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.
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归口单位: D37.02
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