EFSA Unable to Establish Safety of Hemp-Derived CBD Extract as Novel Food in Food supplement

The European Food Safety Authority (EFSA) has concluded that the safety of a carbon dioxide (CO?) extract from industrial hemp varieties of Cannabis sativa L. cannot be established under the proposed conditions of use, following assessment under the EU Novel Foods Regulation.
The opinion was issued in response to a European Commission request regarding authorization of the extract as a novel food pursuant to Regulation (EU) 2015/2283. The product was proposed for use in food supplements at intake levels ranging from 1.12 mg/day for children above 3 years to 3.60 mg/day for adults, excluding pregnant and lactating women.

Key Findings
1.EFSAs NDA Panel concluded it could not complete a safety assessment for the proposed novel food due to significant data gaps.Product Composition Not Adequately characterized the extract contains cannabidiol (CBD) along with other cannabinoids.
2.EFSA noted a substantial proportion of the novel food remains uncharacterized, preventing full assessment of its composition.
3.Stability and toxicological studies submitted by the applicant were conducted using a different test material than the novel food under assessment.
The studies used material produced by isopropanol (IPA)-based extraction, whereas the novel food application concerns CO? supercritical extraction, which may yield materially different compositions.
As a result, EFSA did not consider the submitted studies representative for evaluating the product under review.

No Safety Data for General Population-EFSA also noted no data were provided to support safety in the general population above 3 years of age under the proposed use conditions.
Because safety was not established, the opinion does not support authorization of the novel food as submitted. The conclusion appears driven by insufficient characterization and inadequate supporting data, rather than a definitive finding that the ingredient is unsafe.
Applicants may potentially address the concerns through additional characterization, representative toxicology data and further safety evidence in a future or revised submission.