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New February Deadline Set For CBD Companies Looking To Secure UK Novel Food Authorisation

THE UK Food Standards Agency has set a new deadline of the end of February for the submission of data to support some CBD Novel Food applications, it has emerged.

This comes as one UK company – British Cannabis – has been notified by the FSA that its 15 Novel Food CBD dossiers, spanning over 3,000 products are to be added to the ‘On-Hold’ section of the Public List.

However, as we near the first anniversary of its original publication deadline of March 31, 2021, the FSA has yet to commit to a date as to when the much-awaited Public List will be complete.

Those companies informed by the FSA that they need to provide additional information by the end of February are those which have relied on the desktop safety data from existing CBD studies.

FSA Unable To Give New Deadline

In response to questions from BusinessCann Paul Tossell, Head of Radiological, GM and Novel Foods Branch at the FSA: “Some applicants have used literature reviews of studies to support their applications which is not sufficient evidence based on the Committee on Toxicity’s work. 

“Therefore, we have asked for these applications to be supplemented with additional data by 28 February.”

BusinessCann understands it is referring to data from previous studies, such as those undertaken by GW Pharmaceuticals into the CBD drug Epidiolex.

Mr Tossell added: “There is not sufficient data in the public literature to prove a safety level in food. 

“The applicants who have only provided literature reviews have not provided adequate data for a safety case to be proven for the reasons given above (the CoT review which found that CBD is ‘not safe’). 

“Previous studies have shown that the benefits for therapeutic levels outweighs the risks at those levels of exposure. 

“This is a very different position to foods in the food chain. The application process for food safety will assess what levels are safe in food. Some applicants have already provided this information as part of their application based on the same guidance.”

BusinessCann has pressed the FSA for clarity on whether this February 28 deadline may indicate a new deadline for the Public List to be published.

However, the FSA replied: “We can’t give an exact date for when the public list will be updated. 

“There’s further work needed to evaluate the data sent to us and then add it to the public list so any assumption on publication dates is just speculation. 

“The ‘last updated’ date on the public list webpage will indicate when the list has been updated.”

A Brief Background

The FSA set a deadline of March 31, 2021, for publication of the Public List. This has since slipped on a number of occasions and it has now said there will be two versions of this Public List

There will be the On-Hold one, whereby it still requires additional information. As it says ’where applicants have set out robust plans to complete the risk assessment but are yet to supply all the information needed to continue on in the process’.

The second is those that have been Validated and this currently includes three suppliers and 43 products. These products will be subjected to further risk assessment analysis which, if successful, will see them Authorised for sale in the UK.

The FSA says Validation does not mean that the CBD products are authorised Novel Foods and confirmed as safe for consumption, only that businesses have provided it with adequate information to progress their application.

The FSA received has over 800 applications; rejecting over 600 of these. It says it is still processing over 200 submissions.

First For British Cannabis

In the last week it has emerged that UK firm British Cannabis has been notified by the FSA that it will soon be placed on the On-Hold section of the list – possibly the first company to have heard this from the FSA.

Mr Tossell told BusinessCann: “I can confirm that British Cannabis are part of a consortium application which has sufficient information to be included on the ‘awaiting evidence’ section of the CBD public list in due course. 

“This means the applicants have set out robust plans to complete the risk assessment but have yet to supply all the information needed to continue in the process. We are still in the process of verifying individual products and so we cannot confirm when the public list will be updated.”

British Cannabis is part of the Association for the Cannabinoid Industry consortium application, although it is not yet clear as to the status of the applications of the other consortium members.

David Ralson, Managing Director of British Cannabis, said it was naturally delighted to be informed that the evidence it had submitted in support of 15 dossiers, spanning over 3,000 products, had made it through to the next stage of the process.

Consortia Applications 

In relation to consortia applications the FSA told BusinessCann: “We have not requested any further data from applications that are part of a consortium. However, we will be considering the evidence provided to make sure the material matches the product. If there’s significant difference, then further information may be needed to show the two ingredients are the same toxicologically.

“For the FSA, the most important thing is that the data provided proves the safety case relevant for foods.”

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