CBD brands looking for a last minute gateway to UK Novel Food compliance are being offered a £15,000 consortium lifeline by Europe’s leading hemp group.
The European Industrial Hemp Association (EIHA) currently has around 100 consortium members seeking Novel Food validation for the continued sale of CBD products in the UK, come April 1.
With the deadline just ten days away BusinessCann recently reported that at least three dozen companies – and possibly many more – have been let down by partners who had previously assured them Novel Food validation was in hand.
Now EIHA, which is leading on Europe and the UK’s largest CBD Novel Food consortium, says those brands struggling to stay in the market still have time to piggy-back on its applications.
Paid In Three Instalments
Speaking to BusinessCann Lorenza Romanese, Managing Director, of EIHA, said: “The UK is fragmented market with some 750-plus brands and many of these are small outfits, we have also heard that regrettably many of these have been let down by their previous Novel Food partners.
“What we have is a partner proposal for these businesses which will allows them access to the EIHA consortium at a rate of € 17,250 paid in three instalments over two years.
“They may still have to pay for their own stability – especially if they use a carrier oil other than the hemp seed oil that we will use in the toxicology tests – but these businesses are more than welcome to join our consortium.
“It is very good value; it is payable over two years and it provides the business with a Novel Food licence to continue trading in the UK.”
The EIHA consortium in the process of raising over €3m to take forward three Novel Food applications to both the Food Standards Agency (FSA) in the UK and European Food Safety Authority – the conduit for the 27 member states of the European Union.
Whole Plant Application Pending
EIHA submitted its first Novel Food application to the FSA for a CBD isolate in September and this was closely followed by an application for synthetic CBD.
And, in the next few weeks it will also be submitting an application for a full spectrum, whole plant extract, to both the FSA and the EFSA.
The processes for approval of the applications between Europe and Brexit Britain have diverged recently. In the UK, the FSA has agreed to validate applications which do not have completed details of new toxicology studies.
Validated applications allow the applicant to remain on the market after April 1, until such studies have been completed, and the authorisation process will then be finalised.
Those CBD companies abstaining from the whole Novel Food process face possible enforcement action from UK authorities.
In Europe it is slightly different; EFSA has said no applications will be authorised until the whole process, including toxicology studies, are complete.
Toxicology Test On Rats
EFSA is currently looking at some 50-plus applications and the only two which have been notified as being satisfactory to progress on to the authorisation stage have been for synthetic CBD.
EIHA will begin a toxicology study on three generations of rats for its CBD isolate in the coming weeks. Such studies are designed to demonstrate that CBD is safe.
Over the last 18 months authorities in the both US and the UK have identified potential health issues with CBD at very high doses including damage to the liver, potential male reproductive toxicity and potential harm to unborn children.
EIHA is also offering a secondary cost-effective option for white-label firms supplying their downstream brand partners.
This will cost as little as €1,000 for a business with an annual turnover of less that €10,000; €16,000 for turnover of less that €300,000, rising incrementally on a turnover-based sliding scale.
In the last few days the the FSA has sent out a reminder to CBD businesses saying Novel Food applications will need to be submitted over the next few days to secure validation before April 1.
It said: “Applications will be subject to an eight-day admin check, and it can then take up to 30 working days for an application to be validated.”
This effectively establishes a deadline of February 10 for a Novel Food application to be submitted.