FSA To Publish the List of Novel Food Applicants in December 2021?

Proposed ‘on-hold’ applications are being presented to the FSA Executive Management Team at the end of November 2021, the Global Regulatory Services (GRS) reported on their LinkedIn page on Friday.

The GRS says that in case the FSA Executive Management Team agrees to these ‘on-hold’ applications, the ‘on-hold’ section of the Public List will be updated sometime in December 2021.

There are companies that have submitted complete CBD Novel Food dossiers before 31 March 2021 (approximately 220 complete dossiers) – i.e. they have not declared any missing data – and the FSA is reviewing all of these dossiers with a view to either validate or not validate. The FSA is working through these dossiers in numerical order (up until 31 March 2021), raising questions if needed. Companies must respond within two weeks of receiving questions from the FSA. Once all the complete novel food dossiers (submitted prior to 31 March 2021) have been fully assessed and all questions have been responded to, then the FSA will update the Public List so that it includes all the validated dossiers (on the first tab of the Public List Excel Spreadsheet).

The FSA plans to have a fully ‘stable’ Public List (i.e. validated dossiers plus ‘on-hold’ applications) by the end of 2021 but this is somewhat dependent on the number of questions raised and company response timelines.

Right now, the majority of the UK CBD Novel Food sector will mainly be interested in the publication of the ‘on-hold’ part of the Public List.

If the FSA Executive Management Team agrees to the proposed on-hold applications which will be presented to them by the end of November 2021, the on-hold part of the Public List will be updated by the end of December 2021.

In February 2021, the EIHA projects GmbH, together with ChemSafe, their scientific provider, announced that they have submitted Novel Foods applications for natural CBD isolate and Full Spectrum; fully meeting the Food Safety Authority (FSA) deadline.

Reviewed by Sasha Bajilo, founder of ILESOL Pharmaceuticals, an industrial scale producer of CBD products and formulations. Expert on Hemp/Cannabis policy, member of the Croatian Ministry of Health regulatory commission for medical cannabis.