The European Commission and EU member states must still decide whether to authorize the ingredient by Chanelle McCoy UK Ltd for sale across the European market at intake levels up to 2 mg/day.
While the opinion has been welcomed as an important regulatory step, industry experts have questioned whether the 2 mg daily intake will provide a commercially viable proposition and whether EFSA has applied the same evidentiary requirements to this dossier as for previous applicants.
“After years of data gaps and several negative EFSA opinions, this represents an important turning point for CBD novel food applications,” Jerome Le Bloch, head of scientific affairs at FoodChain ID, shared on LinkedIn. “The dose remains very low compared with many CBD products historically marketed in Europe, but this positive opinion provides an important regulatory precedent for future applications.”
Approvals in motion due to low limit
The opinion marks a significant shift in the regulatory landscape for CBD applications in Europe, following EFSA’s decision in 2022 to place several CBD novel food assessments on hold because substantial data gaps prevented it from establishing the safety of CBD as a food.
However, in February this year, EFSA established a low provisional safe intake level equivalent to around 2 mg per day for a 70 kg adult. This level applies only to supplements with at least 98% purity CBD, free from nanoparticles and produced with a process deemed safe, with genotoxicity excluded.
The authority also applied a strict uncertainty factor of 400 to account for incomplete data and remaining gaps in toxicological evidence.
In its latest scientific opinion, EFSA noted that Chanelle McCoy UK Ltd had initially proposed a maximum daily intake of 25 mg CBD for the novel food but subsequently revised this to 2 mg in line with EFSA’s provisional safe intake level. The company submitted a 90-day sub-chronic oral toxicity study in rats; however, given the remaining data gaps, including those related to reproductive and developmental toxicity, EFSA applied the uncertainty factor of 400 when deriving the provisional safe intake level.
Le Bloch highlighted that the dossier did not contain evidence previously requested from other applicants.
“The lack of reproductive toxicity or human clinical trial is questionable, as EFSA always highlighted these gaps in all publications and requested such data to other applicants,” he wrote.
Mark Tallon, PhD, chief executive officer at Legal Products Group Ltd, noted the approval came down to the applicant’s acceptance of EFSA’s daily limit.
“As a food business you have one option; accept EFSA’s ADI with the result of a dose that will deliver zero physiological or nutritional benefit for the consumer (based on current evidence) or you will be rejected,” he said. “An interesting point here is acceptance of the material not containing nanomaterials based on theoretical justification rather than measured justification.”
Harmonization between UK and EU
The decision comes just weeks after the UK’s Food Standards Agency (FSA) approved the Chanelle McCoy CBD application, along with two others, for ministers to authorize.
However, the FSA adopted a provisional acceptable daily intake of 10 mg CBD per day for healthy adults, five times EFSA’s approximate 2 mg level for a 70 kg adult.
At the same time, the FSA noted the ongoing UK–EU Sanitary and Phytosanitary (SPS) negotiations, which seek to increase regulatory harmonization and reduce cross-border red tape through “dynamic alignment”. Tallon has warned that, as a result, EFSA’s lower daily provisional safe intake level could eventually be adopted by the UK’s CBD sector.
