Turck Dominique, Bohn Torsten, Castenmiller Jacqueline, De Henauw Stefaan, Hirsch-Ernst Karen Ildico, Maciuk Alexandre, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Pelaez Carmen, Pentieva Kristina, Siani Alfonso, Thies Frank, Tsabouri Sophia, Vinceti Marco, Cubadda Francesco, Frenzel Thomas, Heinonen Marina, Marchelli Rosangela, Neuhäuser-Berthold Monika, Poulsen Morten, Prieto Maradona Miguel, Schlatter Josef Rudolf, Trezza Viviana, van Loveren Henk, Albert Océane, Dumas Céline, Germini Andrea, Gelbmann Wolfgang, Kass Georges, Kouloura Eirini, Noriega Fernandez Estefania, Rossi Annamaria, Knutsen Helle Katrine
EFSA J. 2022 Jun 7;20(6):e07322. doi: 10.2903/j.efsa.2022.7322. eCollection 2022 Jun.
The European Commission has determined that cannabidiol (CBD) can be considered as a novel food (NF), and currently, 19 applications are under assessment at EFSA. While assessing these, it has become clear that there are knowledge gaps that need to be addressed before a conclusion on the safety of CBD can be reached. Consequently, EFSA has issued this statement, summarising the state of knowledge on the safety of CBD consumption and highlighting areas where more data are needed. Literature searches for both animal and human studies have been conducted to identify safety concerns. Many human studies have been carried out with Epidyolex, a CBD drug authorised to treat refractory epilepsies. In the context of medical conditions, adverse effects are tolerated if the benefit outweighs the adverse effect. This is, however, not acceptable when considering CBD as a NF. Furthermore, most of the human data referred to in the CBD applications investigated the efficacy of Epidyolex (or CBD) at therapeutic doses. No NOAEL could be identified from these studies. Given the complexity and importance of CBD receptors and pathways, interactions need to be taken into account when considering CBD as a NF. The effects on drug metabolism need to be clarified. Toxicokinetics in different matrices, the half-life and accumulation need to be examined. The effect of CBD on liver, gastrointestinal tract, endocrine system, nervous system and on psychological function needs to be clarified. Studies in animals show significant reproductive toxicity, and the extent to which this occurs in humans generally and in women of child-bearing age specifically needs to be assessed. Considering the significant uncertainties and data gaps, the Panel concludes that the safety of CBD as a NF cannot currently be established.
欧盟委员会已确定，大麻二酚（CBD）可被视为一种新型食品（NF），目前，欧洲食品安全局（EFSA）正在评估19项相关申请。在评估这些申请的过程中，很明显在得出关于CBD安全性的结论之前，存在一些需要解决的知识空白。因此，EFSA发布了本声明，总结了关于食用CBD安全性的知识状况，并强调了需要更多数据的领域。已对动物和人体研究进行文献检索，以确定安全问题。许多人体研究是针对Epidyolex进行的，Epidyolex是一种被批准用于治疗难治性癫痫的CBD药物。在医疗状况的背景下，如果益处大于不良反应，则不良反应是可以耐受的。然而，在将CBD视为新型食品时，这是不可接受的。此外，CBD申请中提及的大多数人体数据研究的是Epidyolex（或CBD）在治疗剂量下的疗效。从这些研究中无法确定无观察到有害作用水平（NOAEL）。鉴于CBD受体和信号通路的复杂性和重要性，在将CBD视为新型食品时需要考虑相互作用。对药物代谢的影响需要阐明。需要研究不同基质中的毒代动力学、半衰期和蓄积情况。CBD对肝脏、胃肠道、内分泌系统、神经系统和心理功能的影响需要阐明。动物研究显示出显著的生殖毒性，需要评估这种情况在一般人群中尤其是育龄妇女中的发生程度。考虑到存在重大的不确定性和数据空白，专家小组得出结论，目前无法确定CBD作为新型食品的安全性。
