Safety of cannabidiol isolated from Cannabis sativa L. as a novel food pursuant to Regulation (EU) 2015/2283.

Turck D.; Bohn T.; Cámara M.; Castenmiller J.; De Henauw S.; Jos &.; Maciuk A.; Mangelsdorf I.; McNulty B.; Naska A. et al. · EFSA journal. European Food Safety Authority · 2026

**Background & Methods** The European Food Safety Authority (EFSA) Panel on Nutrition, Novel Foods and Food Allergens conducted a regulatory review of cannabidiol (CBD) isolated from Cannabis sativa L. as a novel food ingredient pursuant to EU Regulation 2015/2283. The assessment evaluated CBD with ≥98% w/w purity produced via ethanol extraction, winterization, filtration, decarboxylation, and crystallization, intended for use in food supplements targeting the adult population (excluding pregnant and lactating women). **Key Findings** - The EFSA Panel identified critical data gaps preventing a definitive safety assessment, including insufficient information on product identity, manufacturing specifications, compositional analysis, and toxicological properties. - The applicant failed to respond to EFSA requests for additional data on genotoxicity, reproductive and developmental toxicity, and human safety data despite regulatory requirements. - Based on available evidence, the Panel concluded that the safety of CBD as a novel food ingredient cannot be established, resulting in a negative safety opinion. **Dosage & Administration** The proposed maximum intake of CBD was 60 mg/day as an ingredient in food supplements for adult consumers. **Safety & Adverse Effects** Specific adverse effects were not documented in the available data. However, the inability to complete a comprehensive safety assessment due to missing toxicological data (particularly genotoxicity and reproductive/developmental toxicity studies) prevents definitive conclusions regarding safety profile and potential adverse effects. **Evidence Quality** This regulatory review represents a critical evidence gap analysis rather than a primary research study. The major limitation is the applicant's non-compliance with data requests, resulting in incomplete toxicological dossiers. The assessment lacks adequate human clinical trial data, comprehensive genotoxicity studies, and reproductive/developmental toxicity investigations—standard requirements for novel food approval. The conclusion that safety cannot be established reflects insufficient evidence quality rather than demonstrated harm. This represents a regulatory rejection based on incomplete documentation and highlights the need for comprehensive pre-market safety data before novel food authorization.

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