Turck Dominique, Bohn Torsten, Cámara Montaña, Castenmiller Jacqueline, De Henauw Stefaan, Jos Ángeles, Maciuk Alexandre, Mangelsdorf Inge, McNulty Breige, Naska Androniki, Pentieva Kristina, Siani Alfonso, Thies Frank, Aguilera-Gómez Margarita, Cubadda Francesco, Frenzel Thomas, Heinonen Marina, Knutsen Helle Katrine, Marchelli Rosangela, McArdle Harry J, Moldeus Peter, Neuhäuser-Berthold Monika, Schlatter Josef Rudolf, Siskos Alexandros, Trezza Viviana, van Loveren Henk, Albert Océane, Beneventi Elisa, Favata Areti, Kass George E N, Laganaro Marcello, Magani Maura, Nuin Garciarena Irene, Pieger Anna Maria, Rossi Annamaria, Hirsch-Ernst Karen Ildico
EFSA J. 2025 Jul 30;23(7):e9527. doi: 10.2903/j.efsa.2025.9527. eCollection 2025 Jul.
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 -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.
应欧盟委员会的要求，欧洲食品安全局（EFSA）营养、新型食品和食品过敏原小组（NDA）被要求根据欧盟法规（EU）2015/2283，就合成大麻二酚作为新型食品（NF）发表意见。申请所涉及的新型食品是化学合成生产的大麻二酚（CBD），建议以每天30毫克的用量用于食品补充剂。目标人群为普通人群，但孕妇和哺乳期妇女除外。在风险评估过程中，该小组发现了一些数据缺口，申请人需要加以解决。因此，欧洲食品安全局向申请人发送了一份补充信息请求。所要求的数据涉及新型食品的身份、生产工艺、成分数据、规格、遗传毒性、生殖和发育毒性以及人体数据。尽管多次联系，申请人未回复欧洲食品安全局的补充数据请求。基于现有数据，该小组得出结论，无法确定新型食品即合成大麻二酚的安全性。
