Safety Assessment on Cannabidiol (CBD) Isolate Used as a Novel Food for Use in Food supplements. (RP1291)

An application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in October 2021 from Labocan B.V. (“the applicant”) for the authorisation of synthetic cannabidiol (CBD) isolate as a novel food. The novel food is a synthetic CBD isolate which is intended to be used as a food ingredient in food supplements for adults (excluding pregnant and lactating women and other specifically identified vulnerable groups such as those on medication and the immunosuppressed). The novel food was assessed based on the data provided. This review indicated it was appropriate for the provisional ADI for 98% or greater CBD to form part of the evidence for this assessment. For CBD a provisional acceptable daily intake (ADI) of 10 mg/day for a healthy 70 kg adult 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. This is due to remaining data gaps and residual uncertainties concerning the safety of CBD for these groups of consumers. To support the FSA and FSS in their evaluation of the application, the Advisory Committee on Novel Foods and Processes (ACNFP) were asked to review the safety dossier and supplementary information provided by the applicant. 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 does not put consumers at a nutritional disadvantage. The FSA and FSS concluded that the applicant had provided sufficient information to assure the novel food, an isolated synthetic CBD as detailed in application RP 1291, was safe under the proposed conditions of use. The views of the ACNFP have been taken into account in the regulatory assessment, which represents the opinion of the FSA and FSS.