The EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) released its negative response to a Novel Food application from the Swiss brand Cibdol AG and Dutch white label manufacturer Labocan BV, on Nov. 3.
EFSA rejected the application due to a lack of full identity characterization (notably particle size and nanoparticle presence), stability data, genotoxicity studies, reproductive and developmental toxicity data, and human clinical safety data.
The opinion follows the authority’s decision in June 2022 to pause all evaluations due to insufficient safety data across multiple applications.
Mark Tallon, chief executive officer at Legal Products Group Ltd, told NutraIngredients he believes EFSA is looking for a study to prove CBD does not have the potential to cause adverse toxicity effects.
“EFSA expect, in our view, an extended generation study related to reprotoxicity,” he said. “This million-dollar study is almost unmatched in prior EFSA opinions and suggests either a new level of restriction or a political push to have CBD not accepted as a food, irrespective of the data.”
He added: “EFSA continue to ignore over five years continued use across the EU with no evidence of repro-toxicity or hepatotoxicity in users. There was some movement by EFSA in the last gap analysis, but in essence, they are likely to offer a dose so low as to be equivalent as a ban to food businesses.”
He suggested the authority had an expectation beyond standard risk assessment.
“The issue over risk assessment vs. a risk-free guarantee is becoming a reality at EU level,” he said. “The result is companies placing illegal product on the market and not engaging with regulators and risk assessors. We are talking about foods here, not medicines, and they should be assessed as such.”
Luca Bucchini, managing director at Hylobates Consulting, agreed.
“EFSA is being particularly careful with CBD, and the applicant has evidently decided that the burden of performing the additional studies requested exceeded the benefits of potential approval, which is understandable in light of the cost of some of the studies requested,” he told NI. “In general I find remarkable that characterisation at the nano-level has become so important for assessments; I wonder if available evidence really supports such a cautious approach. As for reproductive and developmental toxicity, it is certainly a big roadblock for this and future applicants.”
As of Sept. 2025, EFSA proposed a conservative daily intake limit of 2 mg of CBD per day for food supplements as a result of unresolved toxicological concerns and gaps in safety data.
Jerome Le Bloch, head of scientific department at Nutraveris, told NI at the time that he questioned the methodology it used to come to that conclusion. He said EFSA applied an unusually strict safety margin of 400 instead of the standard factor of 200.
Although the limit opinion did not have an immediate legal effect, EFSA will use this opinion as a reference point in its ongoing Novel Foods assessments.
Lessons for Novel Food applications
Tallon noted that the recent negative opinion provides some lessons for the rest of the industry around the importance of stability data, accreditation of testing laboratories and toxicological studies.
He pointed out that the applicant’s reliance on literature reviews rather than true acute and subchronic studies would be a significant hindrance to the application.
LeBloch further noted the importance of responding to EFSA’s requests for evidence.
“This is negative due to the lack of answers from the applicant to the additional data requests from EFSA,” he said. “As no answer has been provided, it is mandatory to EFSA to close the application by publishing an opinion.”
