Risk assessment
Safety assessment: Synthetic Cannabidiol (CBD) as a novel food for use in food supplements
Executive summary
An application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in January 2021 from Chanelle McCoy CBD Ltd (“the applicant”) for the authorisation of synthetic cannabidiol (CBD) as a novel food.
The novel food is a synthetic >98% pure form CBD which is intended to be used as food supplements for adults.
For CBD a provisional Acceptable Daily Intake (ADI) of 10 mg/day has been published by the FSA and was considered in assessing this novel food. The provisional ADI (section 2.7) was recommended, subject to the existing advice to consumers that pregnant and breastfeeding women and people taking any prescription medication should avoid the consumption of CBD. Consumers on regular medications should seek advice from a medical professional before using any type of CBD food product. In addition, children and prospective parents trying for a baby are advised against consumption of CBD, as are those who are immunosuppressed, due to remaining data gaps and residual uncertainties concerning the safety of CBD for these groups of consumers. These contraindications would also apply to this novel food.
To support the FSA and FSS in their evaluations of the application, the Advisory Committee on Novel Foods and Processes (ACNFP) were asked to review the dossier and supplementary information provided by the applicant. Please note the Committee did not consider any potential health benefits or claims arising from consuming the food, as the focus of the novel food assessment is to ensure the food is safe, and not putting consumers at a nutritional disadvantage.
The FSA and FSS concluded based on the advice of the ACNFP, that the applicant had provided sufficient information to assure the novel food, synthetic CBD, was safe under the proposed conditions of use. The anticipated intake levels and the proposed use in foods and food supplements was not considered to be nutritionally disadvantageous.
The views of the ACNFP have been taken into account in the regulatory assessment which represents the opinions of the FSA and FSS.