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

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 a carbon dioxide (CO₂) extract from industrial hemp varieties of the plant Cannabis sativa L. as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is proposed to be used in food supplements at maximum use levels ranging from 1.12 mg/day for children above 3 years of age to 3.60 mg/day for adults, excluding pregnant and lactating women. The NF contains cannabidiol (CBD) as well as other cannabinoids. The Panel notes that a substantial proportion of the NF remains uncharacterised. Stability and toxicological tests submitted by the applicant were performed with a material different from the NF under assessment, as it was produced using a different production process (i.e. isopropanol (IPA)-based extraction instead of CO₂ supercritical extraction), potentially resulting in different compositional data. Therefore, the absence of adequate stability and of toxicological studies performed with a representative test item prevents the Panel from drawing conclusions on the safety assessment of the NF. Additionally, no data were provided by the applicant to address the safety of the NF in the general population above 3 years of age. Therefore, the safety of the NF under the proposed conditions of use cannot be established.