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When Is The Best Time – And With Whom – To Launch The Required Toxicology Tests For A UK CBD Novel Food Pass?

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FOOD regulators have unveiled further key details for CBD businesses looking to operate in the UK post-Brexit.

The UK is now poised to become the continent’s CBD powerhouse after the European Commission shifted its designation for CBD to a narcotic drug.

In a three-hour series of interviews with UK experts The Canna Consultants (TCC), senior Food Standards Agency (FSA) officials have peeled back further layers on what businesses need to do to continue trading in the UK from April 1, next year.

The Canna Consultants co-director, Steve Oliver.

These will be all available to view in the next few days, at no charge, with the opportunity to make a donation to a worthy charitable cause.

In an interview with BusinessCann, TCC co-directors Steve Oliver and Matt Lawson ran through a few pointers on what viewers can expect.

These include further indications that the onus for assembling the significant quantities of data, and testing, required for a successful Novel Food submission will not fall solely on the shoulders of the ingredient manufacturers.

Mr Oliver said: “The emphasis for establishing the safety and consistency of a product in relation to toxicity, its lack of contaminants and specified cannabinoid contents is the shared responsibility of the seed-to-shelf chain – no one can abrogate their responsibility.

“The interviews give a strong confirmation the manufacturers of end-products will need to undertake their own analysis, as the method of delivery, carrier oils and mechanisms can themselves lever varying degrees of CBD bio-availability in the body.”

Mr Oilver cited a study from GW Pharmaceuticals in which large quantities of CBD were taken by people either fasting, or with milk, or alcohol or a full-fat breakfast, which demonstrated a 500% variation in bioavailability.

FSA Safety View Likely In October 

During the interviews with the FSA’s Novel Food lead Paul Tossell and compliance lead Frances Hill, they say the FSA expects to get a final report from the Committee on Toxicity (CoT) on the potential risks associated with CBD use in August.

In February, this year, the CoT first flagged-up its concerns that CBD is not safe. It said data secured from GW Pharmaceuticals indicated its potential to cause damage to the liver, as well as possible negative reactions with other drugs, in particular the blood-thinner Warfarin.

Mr Oliver added: “The FSA is awaiting guidance from two advisory committees – in addition to that from the CoT.  We understand that those committees do not next meet until September and so any guidance which emanates from their meetings will not be available until, most likely, October.

“Obviously it’s difficult to undertake toxicology tests when you’re not sure what you are testing for, so for now, it may be wise for businesses to wait until we have clear guidance before pursuing these tests.

“We are still not fully aware of what the CoT guidance on this will be, and so we still do not know what is required.”

Vertical, Not Horizontal Consortia

However, he said now is not the time to sit back, and brands should be speaking to their partner suppliers and looking to collaborate on Novel Food applications – possibly considering joint tests and trials.

Mr Lawson, said:  “Such collaboration, as is required, is best effected within vertical supply-chains, with partners working together for their mutual benefit, rather than horizontally amongst competing supply-chains.

“This was something that we discussed with the FSA, who confirmed that in a horizontally-syndicated approach, there was a real possibility that the individual cannabinoid ingredient upon which toxicology was performed was the only one from the syndicate which received Validation, because of a lack of substantial equivalence to the other cannabinoid ingredients within the syndicate.  

Despite claims that some 20-or-so
firms had submitted Novel Food
applications, Mr Tossell says, during
the interview, that the actual
number is less than 10.

“At The Canna Consultants we are establishing collaborations within vertical supply-chains for the direct benefit of those within them.”

FSA Will Require Toxicology-Test Specifics

The FSA has already indicated that it is prepared to validate an application before the deadline of March, 31, next year, as long as it has sufficient detail on the nature of the toxicology tests being undertaken.

In tandem, with it flagging up its concerns on the safety of CBD the FSA has also said that those companies wishing to sell CBD from April 1, next year, need have to have submitted, and have had Validated, a Novel Food application.

Mr Lawson said that despite claims that some 20-or-so firms had submitted Novel Food applications, Mr Tossell says, during the interview, that the actual number is less than 10.

Those wishing to register to view the interviews can do so here. TCC says those who view the event can choose to make a donation to the NHS Charities through the Just Giving link on registration page.  It produced the interviews with RASB Media.

Peter
Peter McCusker is an experienced news and business editor, who believes it’s time to fully embrace the multiple, proven, medical benefits of the cannabis plant.

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