TY - JOUR
T1 - Safety of cannabidiol isolated from Cannabis sativa L. as a novel food pursuant to Regulation (EU) 2015/2283.
AU - Turck, Dominique
AU - Bohn, Torsten
AU - Cámara, Montaña
AU - Castenmiller, Jacqueline
AU - De Henauw, Stefaan
AU - Jos, Ángeles
AU - Maciuk, Alexandre
AU - Mangelsdorf, Inge
AU - McNulty, Breige
AU - Naska, Androniki
AU - Pentieva, Kristina
AU - Siani, Alfonso
AU - Thies, Frank
AU - Cubadda, Francesco
AU - McArdle, Harry J
AU - Trezza, Viviana
AU - Albert, Océane
AU - Beneventi, Elisa
AU - Laganaro, Marcello
AU - Nuin Garciarena, Irene
AU - Rossi, Annamaria
AU - Berrío Cruz, Sebastián
AU - Seminati, Francesca
AU - Magani, Maura
AU - Hirsch-Ernst, Karen Ildico
AU - EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)
N1 - © 2026 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.
PY - 2026/9/21
Y1 - 2026/9/21
N2 - 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 cannabidiol (CBD) isolated from Cannabis sativa L. as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of ≥ 98% w/w CBD. The NF is produced via ethanol extraction, followed by winterisation, filtration, decarboxylation and crystallisation. It is intended to be used as an ingredient in food supplements at a maximum intake of 60 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.
AB - 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 cannabidiol (CBD) isolated from Cannabis sativa L. as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of ≥ 98% w/w CBD. The NF is produced via ethanol extraction, followed by winterisation, filtration, decarboxylation and crystallisation. It is intended to be used as an ingredient in food supplements at a maximum intake of 60 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.
UR - https://pubmed.ncbi.nlm.nih.gov/42769824/
U2 - 10.2903/j.efsa.2026.10318
DO - 10.2903/j.efsa.2026.10318
M3 - Article
C2 - 42769824
SN - 1831-4732
VL - 24
JO - EFSA Journal
JF - EFSA Journal
IS - 9
M1 - e10318
ER -