At the request of the European Commission, the Panel on Nutrition, Novel Foods, and Food Allergens (NDA) of the European Food Safety Authority (EFSA) was tasked with providing an opinion on the use of carbon dioxide extract from Cannabis sativa L. as a novel food under Regulation (EU) 2015/2283.
The NF under assessment is a food supplement provided in the form of an oily liquid solution. The proposed target population is the general population above three years of age, excluding pregnant and breastfeeding women.
The NF is an extract obtained from the flowers and leaves of industrial hemp varieties of the plant C. sativa L. using CO2 supercritical extraction. It consists of 54.2%–58.0% w/w total cannabinoids and 1.6%–2.7% w/w terpenes. The Panel notes that among the characterised fractions, cannabinoids other than CBD are present. A substantial fraction (between 20% and 30% w/w) of the NF remains uncharacterised.
The stability and toxicological testing were performed using test items extracted using IPA. The two different extraction processes (i.e. IPA and supercritical CO2) may result in extracts with different compositional profiles, particularly with respect to minor constituents, residual solvents, and the relative abundance of cannabinoids and other lipophilic compounds.
Therefore, the Panel does not consider the IPA extracts as representative of the NF since the degree of uncharacterised fraction of the NF prevents a comprehensive understanding of the constituents present in it and their potential toxicological relevance.
Additionally, no data were provided by the applicant to address the safety of the NF in the general population above three years of age.
The Panel, therefore, concludes that the submitted data cannot be used to support the stability and toxicological assessment of the NF.
About CIRS Food Division
Established in 2012, the Food Business Division of CIRS Group has helped over 1,000 food companies globally in achieving one-stop compliance solutions. CIRS offers a full range of regulatory services, including but not limited to China novel food applications, synthetic biology-derived foods, U.S. GRAS notices, EU novel food applications, health food registration, and food for special medical purposes (FSMP).
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
