EFSA puts novel food assessment on hold for applicants to provide missing data

A hold has been placed on European novel food assessment after the European Food Safety Authority (EFSA) said it was unable to proceed due to identified knowledge gaps in safety data.

In a statement released on 7th June, the EFSA said that more data are needed in order for its experts to reach a conclusion on the safety of CBD as an ingredient in food products.

“We have identified several hazards related to CBD intake and determined that the many data gaps on these health effects need filling before these evaluations can go ahead,” said Dominique Turck, chair of the EFSA’s expert panel on Nutrition, Novel Foods and Food Allergens (NDA).

The NDA panel added that the information gaps detected in the 19 applications it was assessing are not an indication that CBD food products are not safe.

“It is important to stress, at this point, that we have not concluded that CBD is unsafe as food,” Turck said.

Missing data mentioned by the panel included the effect of CBD on the liver, gastrointestinal tract, and endocrine and nervous systems, as well as consumers’ psychological wellness, the EFSA said in a note.

According to the panel, it is also important to determine whether the significant adverse effects of ingested CBD on reproduction observed in animal studies may also occur in humans.

Based on the panel’s report, while studies carried out on authorised CBD medical drug Epidiolex – used to treat severe cases of epilepsy – show that CBD products can be used in the treatment of certain health issues, they are not necessarily safe when consumed as food.

“In the context of medical conditions, adverse effects are tolerated if the benefit outweighs the adverse effect,” the experts wrote. “This is, however, not acceptable when considering CBD as a novel food.”


Stopping the clock to keep moving


A spokesperson from the EFSA told CBD-Intel that the next step for applicants will be to provide data to fill in the information gaps.

Until then, the nine-month time frame the EFSA is given, based on EU regulations, to come up with a risk assessment for validated applications will be paused only to resume counting after candidates have provided the requested information.

“EFSA’s risk assessments of the 19 applications received are on hold until the applicants provide the missing data,” the EFSA’s spokesperson said. “After all the necessary data is provided, EFSA will restart the clock and complete its risk assessment within nine months, which exclude the time taken by the applicant to provide missing data or clarifications.”

The period of time that applications are put on hold may vary from case to case.

“EFSA is engaging with all the applicants to explain what information and clarifications are needed in relation to their application, as needs may slightly differ across different applications,” the EFSA’s spokesperson told CBD-Intel. “Some of the applicants may already be in a position to provide information addressing some of the data gaps.”

The further delay signalled by the long-awaited announcement on the 19 applications that have been validated – and thus are being assessed by the EFSA – has caused worry, but the regulator says this is part of a normal procedure.

“Stopping the clock on a novel food assessment is not unusual when information is missing,” said the EFSA’s head of nutrition and food innovation unit, Ana Afonso.

“It’s the responsibility of applicants to fill data gaps, and we are engaging with them to explain how the additional information can be provided to help address the uncertainties,” she said.


Will missing data mean a missed deadline?


On 28th June the EFSA will hold an online information session for applicants and other participants who may have an interest in the issue.

It is not clear what kind of information will be provided by the agency during the session and whether this would include guidance for applicants to clarify the panel’s doubts.

The first applications for CBD as a novel food were validated by the European Commission (EC) earlier this year.

The EC then requested a risk assessment from the EFSA, which was expected to reach a conclusion by November this year.

The request for missing data from the NDA panel now makes it very unlikely for any of the applications to receive an assessment within that deadline.

– Tiziana Cauli CBD-Intel staff

Photo: Pexels

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