Standard Guide for Determining a Point of Departure (POD) or Assigning a Threshold of Toxicological Concern (TTC), if needed, for Use in a Toxicological Risk Assessment of a Non-Cannabinoid Ingredient Intended for Use in Cannabinoid Products for Vaporization

Importancia y uso:

4.1 Significance: 

4.1.1 This guide establishes an approach for conducting a toxicological risk-based assessment of non-cannabinoid ingredients designed to reduce the potential health risks when used in cannabinoid products intended for vaporization.

4.1.2 This guide helps to reduce consumer health risks when using products that contain non-cannabinoid ingredients that are not currently regulated in most jurisdictions.

4.1.3 This guide can aid in reducing product risk for consumers while maintaining consumer access to a wide variety of cannabinoid-containing vaporization products.

4.1.4 This guide will help to guide regulators and manufacturers in prioritizing non-cannabinoid ingredients used in consumer products containing cannabinoids intended for vaporization for additional evaluation.

4.1.5 This guide can assist regulators and manufacturers in minimizing instances when a restricted substance is replaced with a potentially more hazardous substance by performing a risk assessment of all options and understanding their unique acceptable daily inhalation limit.

4.1.6 When this guide is applied to product manufacturing it can improve consumer confidence in cannabinoid-containing products intended for vaporization.

4.2 Use: 

4.2.1 This guide is ONLY intended to be used to reduce potential negative consumer health risks from vaping non-cannabinoid ingredients.

4.2.2 This guide is NOT to be used to identify a non-cannabinoid ingredient or cannabinoid product as being safe for inhalation. Following this guide does not give the authority to claim a non-cannabinoid ingredient or cannabinoid product is safe for inhalation.

4.2.3 This guide is intended to only be used to evaluate one non-cannabinoid ingredient at a time.

4.2.4 This guide is intended to be utilized to conduct a risk assessment of non-cannabinoid ingredients regardless of whether the cannabinoids in the product have been botanically-derived, produced through precision fermentation, or manufactured in a lab.

4.2.5 This guide is intended to be utilized in conjunction with an acceptable daily inhalation limit calculator which includes conservative uncertainty factors and appropriate correction factors for the selected POD or TTC.

4.2.6 Manufacturers can utilize this guide to conduct a first-pass assessment of non-cannabinoid ingredients used in their products.

4.2.7 Regulators can use the methodologies outlined in this guide and complementary standards for deriving individual ingredient limits. Using this guidance, state regulators will have a scientific process to create restrictions that can reduce consumer health risks and encourage legal cannabinoid-containing product manufacturers and consumers to stay in the regulated market.

4.2.8 This guide is intended to be used with the current body of literature and as new scientific data becomes available.

4.2.9 Although not advised, this guide can be used by a consumer to conduct their own risk assessment related to cannabinoid-containing products intended for vaporizer.

4.2.10 It is the responsibility of the user to understand the concepts presented in this guide and to utilize them appropriately.

Subcomité:

D37.08

Volúmen:

15.10

Número ICS:

65.160 (Tobacco, tobacco products and related equipment)

Palabras clave:

additives; cannabis; CBD; CBDA; d9-THC; flavor; flavour; hemp; marijuana; non-cannabis additive; non-cannabinoid ingredient; point of departure; risk assessment; terpene; THC; THCA; toxicology;