On February 9, 2026, the European Food Safety Authority (EFSA) issued an updated statement establishing a provisional safe intake for cannabidiol (CBD) when used in the form of food supplements.

CBD, extracted from hemp, is marketed in dietary supplements commonly referred to as CBD oils, typically containing 5%-40% CBD dissolved in edible oil. These products are promoted with a range of health claims, most often related to pain (32%), anxiety disorders (27%), sleep disturbances (14%), and stress (10%).

The statement comes amid continued commercialization of CBD as food supplements across the EU, despite persistent gaps in toxicologic evidence.

Novel Food Framework

The European Commission considers that CBD may fall within the scope of the EU Novel Food Regulation, provided all applicable regulatory requirements are met.

In the EU, a novel food is defined as a food that was not consumed to a significant degree before May 15, 1997, the date on which the first regulation governing this category entered into force.

Novel foods may include

• Newly developed or innovative foods, including CBD-based supplements
• Foods produced using new technologies or manufacturing processes, such as ultraviolet treated foods designed to increase vitamin content
• Foods traditionally consumed outside the EU, such as chia seeds

The European regulatory framework is based on three core principles: 

• Consumer safety
• Appropriate and nonmisleading labeling
• Absence of nutritional disadvantages when a novel food replaces an existing product

Before market authorization, novel foods must obtain prior approval from EFSA, which conducts a scientific risk assessment to determine compliance.

In its updated statement, EFSA’s Panel on Nutrition, Novel Foods and Food Allergens (NDA Panel) established a provisional safe intake of 0.0275 mg/kg body weight/d, corresponding to approximately 2 mg/d for a 70 kg adult.

EFSA emphasized that this intake level is provisional because the available scientific evidence remains incomplete.

When data is insufficient, EFSA has the option of defining a provisional dose. This provisional dose incorporates an additional safety factor, designed to protect public health despite the uncertainties.

The current assessment reflects previously identified data gaps, highlighted in a June 2022 statement, regarding potential effects of CBD on the liver and on the endocrine, nervous, and reproductive systems.

EFSA stated that it will reassess the safety threshold once additional toxicologic and human data become available.

The provisional intake applies only to dietary supplement formulations containing CBD with a purity of at least 98%, without nanoparticles, produced through manufacturing processes considered safe, and for which genotoxicity has been excluded.

EFSA also stated that safety cannot currently be determined for individuals younger than 25 years, pregnant or breastfeeding women, or individuals receiving pharmacologic treatment.

This story was translated from Univadis France, part of the Medscape Professional Network.