EFSA Issues First Positive Opinion for CBD Food Supplement

The European Food Safety Authority (EFSA) has delivered its first positive opinion on a CBD food application. This opinion, for a product from Irish supplements company Chanelle McCoy, considers cannabidiol safe for adults over 25, excluding those on medication and pregnant or breastfeeding women.

EFSA's assessment establishes a safe daily intake level of 0.026 mg per kilogram of body weight. For a typical 70-kg adult, this equals 2 mg per day. This limit applies specifically to food supplement formulations where CBD purity is 98% or higher.

A Long Road to a Positive Opinion

CBD is classified as a novel food in the EU, meaning it was not widely consumed there before May 1997. The path to this opinion has been difficult. Since 2010, over 2,000 novel food assessments for botanicals, including CBD, have been paused. EFSA halted all CBD assessments in 2022 due to insufficient safety data, a situation confirmed in late 2025.

More than 100 applications for CBD products have been submitted without a single positive opinion until now. The authority's latest decision is therefore seen as a potential turning point for the ingredient's market access.

Addressing Data Gaps with Conditions

EFSA issued its positive opinion despite acknowledging existing data gaps. To address these, the applicant, Chanelle McCoy, was required to provide additional studies. These included reproductive and developmental toxicity research and a human clinical study on CBD consumption.

The panel also imposed strict limits. Proposed product uses were restricted, and the target population was narrowed to adults over 25. EFSA stated it found no concerns regarding genotoxicity and did not consider CBD nutritionally disadvantageous. The panel deemed the provided data and these conditions sufficient for a favorable opinion on this specific application.

The Final Hurdle for EU Approval

With EFSA's positive opinion issued, the final decision now rests with the European Commission and EU Member States. They must decide whether to formally approve Chanelle McCoy's CBD oil-based food supplement for the European market.

The opinion does not constitute a blanket approval for all CBD products. Each application is assessed individually. However, this landmark opinion significantly improves the likelihood of CBD food supplements eventually reaching EU consumers, following years of regulatory uncertainty and paused assessments.