Introduction
In this guide
In this guideThis is a paper for discussion. This does not represent the views of the Committee and should not be cited.
1. Following a request from the European Commission (EC), the European Food Safety Authority (EFSA) Panel on Contaminants in the Food Chain (CONTAM Panel) were asked to review the existing scientific evidence and all new relevant studies with the aims:
i) To provide scientific opinion on deriving a Health-Based Guidance Value (HBGV) for Δ8-tetrahydrocannabinol (Δ⁸-THC) in food.
ii) To assess the occurrence of Δ⁸-THC food and considering co-occurrence with Δ⁹-THC.
iii) Evaluating toxicological and pharmacological data.
2. This paper provides a summary of the approach used by the EFSA CONTAM Panel to derive a HBGV for Δ⁸-THC in food and a brief summary of the approaches and studies used to reach the conclusion. See link in Annex A.
3. The COT are being asked to review the draft opinion and provide any comments they may have; the Secretariat will then submit the Committee’s comments to EFSA.
4. A document has been provided in the Teams folder for Members to provide comments before and after the Meeting but Members can also send any additional comments directly to the Secretariat. The closing date for the public consultation is the 15th of September 2025. Please provide any comments latest by Wednesday the 10th of September, comments received after this deadline will not be included. Please add the section and/or line number where possible.
5. The background section to this cover paper provides some US Food and Drug Administration (FDA) adverse event reports involving Δ⁸-THC-containing products which may be of interest to COT Members as well as information on the Joint position paper from the Advisory Committee on Novel foods and Processes (ACNFP) & Committee on Toxicity (COT) on establishing a Safe Upper Limit for delta-9-tetrahydrocannabinol (Δ9-THC) and its precursor as including CBD novel foods to provide context.