The final weeks of 2020 generated considerable positive news for the commercial cannabinoid sector.
With the European Commission (EC) stating that they will begin assessing novel food dossiers on CBD again, ACI started 2021 by engaging the EC in constructive dialogue regarding our consortium approach to novel food applications.
In order to meet the UK FSA’s deadline of 31st March 2021, we have followed EFSA guidelines in regards to the data required for a novel foods dossier. At this inaugural meeting we gained clarity in regards to the EC’s position on scientific data for novel foods applications intended for the EU. They maintained that following EFSA guidelines ‘to the letter’ is the most pragmatic route to take. We welcome this stance.
“We were heartened by the positive feedback from the Commission on our consortium approach,” says Dr Parveen Bhatarah, who is leading ACI’s safety consortium submission. “From the outset, ACI have followed EFSA novel foods guidelines to ensure that we meet the deadline of 31 March 2021 set by the UK FSA. As we have focussed on generating the required data as per EFSA guidelines, in particular pre-toxicological technical due diligence of the companies with evidence based scientific testing data, our consortium is well positioned for a European submission.”
The EC representatives advised that unlike in the UK, where a submission can be made with a commitment to generate the required data in the future, full datasets would be required before submitting a dossier in order to have it evaluated. This is an important difference in approach by the two regulatory authorities.
We look forward to continuing this constructive dialogue with EC representatives to gain further clarity and carry on working towards full European novel foods authorisation for our consortium members.