Safety Assessment on Isolated Cannabidiol (CBD) as a Novel Food for Use in Food Supplements (RP427)

Abstract

An application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in February 2021 from EIHA Projects GmbH (“the applicant”) for the authorisation of isolated cannabidiol (CBD) as described in RP427, as a novel food. This is a joint application from EIHA associated product partners pertaining to a novel food which is to be prepared and used according to the specification set out within this document. It must be noted that any authorisation subsequent to this application pertains solely to the novel food and not to any proposed uses as an ingredient in any other products. The novel food is a >98% pure, hemp-derived CBD isolate which is intended to be used in hemp oil as a food supplement for adults. For CBD a provisional Acceptable Daily Intake (ADI) of 10 mg/day for a healthy 70kg 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 that certain populations do not consume CBD, 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 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 not putting consumers at a nutritional disadvantage. The Committee concluded that the applicant had provided sufficient information to assure the novel food, an isolated CBD as detailed in application RP427, was safe under the proposed conditions of use. The anticipated intake levels and the proposed use in food supplements was not considered to be nutritionally disadvantageous.