Safety of Cannabis sativaL. extract 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 safety assessment of Cannabis sativa L. extract as a novel food ingredient pursuant to EU Regulation (EU) 2015/2283. The extract, produced via supercritical CO2 extraction followed by winterisation, decarboxylation, purification, and high-vacuum distillation, was evaluated for use as a food supplement ingredient in the adult population (excluding pregnant and lactating women). **Key Findings** - The novel food extract contains 57%-65% w/w cannabidiol (CBD) and 9%-17% w/w of other cannabinoids, with a proposed maximum daily intake of 30 mg/day. - The EFSA Panel identified significant data gaps requiring applicant response, including information on product identity, production process specifications, compositional data, genotoxicity, reproductive and developmental toxicity, and human safety data. - The applicant failed to provide responses to the EFSA's data requests, resulting in the Panel's inability to establish safety for this novel food product. **Dosage & Administration** Maximum proposed intake: 30 mg/day as a food supplement ingredient in the adult population (excluding pregnant and lactating women). **Safety & Adverse Effects** Not reported. The Panel could not complete a comprehensive safety assessment due to insufficient data submission from the applicant. **Evidence Quality** This is a regulatory review with critical limitations. The assessment was substantially compromised by the applicant's non-compliance with information requests. The Panel explicitly stated that "the safety of the NF cannot be established" based on available data. Key evidence gaps included lack of genotoxicity studies, reproductive and developmental toxicity data, and human safety evidence. The absence of applicant-provided data severely restricted the ability to conduct a thorough risk characterization. This regulatory opinion represents a negative determination for novel food approval, indicating that the current evidence base is insufficient to support authorization under EU food law. The findings underscore the importance of comprehensive pre-market safety documentation for novel food ingredients.

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