LATEST figures from the Food Standards Agency on the progress of applications for CBD products to be included in the UK Novel Food catalogue will make worrying reading for many in the industry.
The FSA says it has received 803 applications since January 1 and of these 317 have moved on to the next stage – with four having progressed through this Validation phase and on to Authorisation.
However, this still leaves some 486 outstanding, with the FSA confirming that 41 of these have been withdrawn.
What of the other 445? Well the FSA has been hard to pin down on what the situation is with these – but it does not look promising.
No Further Progress
The FSA has said that these applications are classed as ‘Incomplete’ and it initially told BusinessCann that the applicants were being given ‘at least 7 days to upload requested information’.
With the application deadline being March 31, the seven-day window is now well behind us. When pressed, the FSA added: “Companies with applications missing some information have been given a chance to upload the missing information. If this is not done these applications will not progress any further.”
With the FSA set to update the current Public List of four Validated applications, between now and June, the chances of these applications making it through the initial Administrative check now look slim.
This has not come as a surprise to Steve Oliver, Co-Founder and Director of The Canna Consultants. It has worked on Novel Food submissions for around a dozen applicants with some of these running to 500-plus pages, and costing around £500,000.
He said: “Many applicants have not taken the process seriously enough and seemed to have made no effort.
“Some thought it would be a cut-and-paste job that could be completed in an afternoon. However. It is anything but; it’s very time-consuming, involving a huge amount of work and data collection in relation to a host of topics.”
For further background on just how onerous this process can be see this earlier BusinessCann article.
The remaining 300-plus applicants will be hoping their names are the next appear on the FSA’s Public List of CBD products which will be allowed to stay on the market between now and a decision on their Authorisation.
The first instalment of this Public List was published on April 19 and currently features four bulk ingredient suppliers with some 43 products linked to these Validated applications.
Those brands with products that do not make it on to the Public List (and its On-Hold cousin – for applications which require additional safety data) are at risk of enforcement action from Trading Standards and the FSA.
Three Stages To The Novel Food Process
However Mr Oliver added: “The FSA initially promised to have this process competed by March 31 and it now it says it will be June.
“The Public List needs to be completed as quickly as possible to allow the regulators policing the market to have the certainty they need to enforce it.
“This needs to be undertaken as soon as possible. As well as the 486 who look they will fail the process we have hundreds more who have made no effort to align with any of the Novel Food process and continue to sell their products.”
The first stage of securing a Novel Food permit is the Administrative check, which is designed to ensure all the required documentation is in place, the second is Validation; ensuring it matches the requirements, including details on safety and toxicology studies and finally Authorisation.