Abstract
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on <i>Cannabis sativa</i> L. extract as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of 57%-65% w/w cannabidiol (CBD) and 9%-17% w/w of other cannabinoids. The NF is produced via supercritical CO<sub>2</sub> extraction followed by winterisation, decarboxylation, purification and high-vacuum distillation. It is intended to be used as an ingredient in food supplements at a maximum intake of 30 mg/day. The proposed target population is the adult population, excluding pregnant and lactating women. During the risk assessment, the Panel identified a number of data gaps, which needed to be addressed by the applicant. Therefore, EFSA requested additional information on the identity, production process, compositional data, specifications, genotoxicity, reproductive and developmental toxicity and human data of the NF. The applicant did not reply to these data requests. Based on the available data, the Panel concludes that the safety of the NF cannot be established.
Authors
Turck D, Bohn T, Cámara M, Castenmiller J, De Henauw S, Jos Á, Maciuk A, Mangelsdorf I, McNulty B, Naska A, Pentieva K, Siani A, Thies F, Cubadda F, McArdle HJ, Trezza V, Albert O, Beneventi E, Laganaro M, Nuin Garciarena I, Rossi A, Berrío Cruz S, Seminati F, Magani M, Hirsch-Ernst KI