TY - JOUR
T1 - Safety of synthetic cannabidiol 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 - Aguilera-Gómez, Margarita
AU - Cubadda, Francesco
AU - Frenzel, Thomas
AU - Heinonen, Marina
AU - Knutsen, Helle Katrine
AU - Marchelli, Rosangela
AU - McArdle, Harry J
AU - Moldeus, Peter
AU - Neuhäuser-Berthold, Monika
AU - Schlatter, Josef Rudolf
AU - Siskos, Alexandros
AU - Trezza, Viviana
AU - van Loveren, Henk
AU - Albert, Océane
AU - Beneventi, Elisa
AU - Favata, Areti
AU - Kass, George E N
AU - Laganaro, Marcello
AU - Magani, Maura
AU - Nuin Garciarena, Irene
AU - Pieger, Anna Maria
AU - Rossi, Annamaria
AU - Hirsch-Ernst, Karen Ildico
AU - EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)
N1 - © 2025 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.
PY - 2025/7/30
Y1 - 2025/7/30
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 synthetic cannabidiol as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF which is subject of the application is
trans-cannabidiol (CBD), produced by chemical synthesis and proposed to be used in food supplements at a level of 30 mg/day. The target population is the general 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, an EFSA request for additional information was sent to the applicant. The requested data concerned the identity, the production process, the compositional data, the specifications, the genotoxicity, the reproductive and developmental toxicity and the human data of the NF. Despite being contacted several times, the applicant did not reply to EFSA's requests for additional data. Based on the available data, the Panel concludes that the safety of the NF, i.e. synthetic cannabidiol, 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 synthetic cannabidiol as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF which is subject of the application is
trans-cannabidiol (CBD), produced by chemical synthesis and proposed to be used in food supplements at a level of 30 mg/day. The target population is the general 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, an EFSA request for additional information was sent to the applicant. The requested data concerned the identity, the production process, the compositional data, the specifications, the genotoxicity, the reproductive and developmental toxicity and the human data of the NF. Despite being contacted several times, the applicant did not reply to EFSA's requests for additional data. Based on the available data, the Panel concludes that the safety of the NF, i.e. synthetic cannabidiol, cannot be established.
UR - https://pubmed.ncbi.nlm.nih.gov/40741368/
U2 - 10.2903/j.efsa.2025.9527
DO - 10.2903/j.efsa.2025.9527
M3 - Article
C2 - 40741368
SN - 1831-4732
VL - 23
JO - EFSA Journal
JF - EFSA Journal
IS - 7
M1 - e9527
ER -