Safety Assessment on the Safety of Cannabidiol (CBD) Isolate as a Novel Food for Use in a Range of Food Categories Including Food Supplements (RP61)

An application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in January 2021 from Farmabios (“the applicant”) for the authorisation of cannabidiol (CBD) isolate as a novel food. The novel food is a 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 including those taking medication and the immunosuppressed). 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 ACNFP assessed the novel food on the data supplied by the applicant. It was concluded this data was insufficient in this case due to a lack of administrative provenance. The applicant failed to provide the required level of data to assure data integrity and study quality of the pivotal study and the safety of the novel food was therefore not proven. The FSA and FSS concluded that the applicant had provided insufficient information to assure the novel food, a synthetic CBD isolate as detailed in application RP61, 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.