The FSA Novel Food authorisation process is a two-stage process. The first part is known as Validation where dossiers submitted have been checked and completed against a list of requirements which include:
- Data from the literature and some in vitro information (performed or taking place in a test tube, culture dish, or elsewhere outside a living organism.)
- In vivo toxicology (animal) - (performed or taking place in a living organism.)
- Long term safety (or risk management)
After a full year since of the start of the Novel Foods Process, and with much pressure from the CTA and others to the FSA, DEFRA and the Home Office, the FSA are finally publishing 3,500 product lines (out of an original circa. 10,000) for the first part of Validation.
This only helps wholesalers not white labelling companies as the FSA has not yet validated a process to allow white labellers to reference a bulk Novel Foods product dossier. This is obviously affecting a huge part of the UK CBD supply chain and the CTA are working on this severe bottleneck to UK & British Isles cannabis market.
The second stage of FSA is full Authorisation which will take more than a year to fulfil from this point onwards. During this period, ANY validated product may be removed from the FSA list or put on hold once more. It is important for retailers to keep an eye on the FSA list for changes.
The process that the FSA have used for CBD is unprecedented because they allowed CBD brands, that were on the market prior to 13th February 2020, to remain on sale. In general, any novel food (a product or ingredient not produced in the EU before 15th May 1997), must complete authorisation before being allowed to be sold to the public.
With our exit from the EU and the need to submit dossiers through the ‘new’ UK portal on January 1st, 2021, this created an advantage for EU brands, who were able to submit through the EFSA process prior to Brexit. This is the reason previously listed brands of 22nd February 2022, were validated before any UK brands were listed. There is some doubt to their validity because of the February 2020 date. This is not the Brexit that was promised...
To date, there are still only six companies validated and the rest still remain 'on hold' since 31st March 2021.
Be assured the CTA is working to open the CBD and cannabis markets across the British Isles.
We will update the industry as soon as we are able to.
Marika Graham-Woods – [email protected] 07798 871171
Sian Phillips – [email protected]