EFSA Delivered Safety Opinions on Cannabidiol (CBD) as A Novel Food

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) obtained by chemical synthesis as a novel food (NF) pursuant to Regulation (EU) 2015/2283.

The NF consists of ≥ 98% (w/w) CBD and is intended to be marketed exclusively dissolved in medium-chain triglyceride (MCT) oil in food supplements at a maximum daily dose of 2 mg. The proposed target population is the general adult population over 25 years old and excluding pregnant and breastfeeding women. The safety of CBD in individuals taking medications cannot be established.

The information provided on the production process, composition, and specifications of the NF does not raise safety concerns. The NF is not considered to be nutritionally disadvantageous, and no concerns were identified with respect to genotoxicity.

The applicant submitted a 90-day subchronic oral toxicity study with the NF in which the liver was identified as the key target organ, with female rats being more sensitive than males. A BMDL10 of 10.5 mg/kg bw of CBD per day was derived for increased liver weight relative to body weight in female rats.

In view of the remaining data gaps, including those related to reproductive and developmental toxicity, the uncertainty factor proposed in the Updated Statement on the safety of CBD published by EFSA in 2026 (i.e. 400) was applied to derive a safe intake level for cannabidiol of 0.026 mg/kg bw per day (2 mg/day for a 70-kg adult).

The Panel concludes that the NF is safe under the proposed conditions of use, except for people taking medication, for whom safety could not be established.

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Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan, and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services, from regulatory compliance, laboratory testing, and R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.

The vast majority of members in CIRS Food Business Division have over 10 years of professional experience in food compliance, with more than 80% holding Master’s or Doctoral degrees in food-related disciplines. The CIRS toxicology expert team consists of 24 Chinese Certified Toxicologists (DCST), 2 American Board Certified Toxicologists (DABT), and 1 European Registered Toxicologist (ERT). CIRS has provided one-stop food compliance services to over 1,000 domestic and international food and related enterprises. Leveraging its technical expertise, diverse resources, and global network, the CIRS Food Business Division offers global food compliance services, including but not limited to:

• Health food registration and filing in China;
• Application for “Three New Foods (new food additives, new food raw materials and new food-related products” in China;
• U.S. GRAS, NDI, and CAP notifications;
• EU Novel Food, food additives, and food enzymes applications; and
• Application for new feed ingredients and feed additives in China, the U.S., and the EU.

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