UK regulators trim 67 applications from novel food consideration

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The fate of 67 CBD food safety applications is unclear as UK food safety authorities reported June 1 that only 250 are still under active review. The Food Safety Agency (FSA) had said 317 applications were still under consideration when it last reported figures at the end of April. More than 800 total applications have been submitted to the FSA so far.

It remains unclear whether those 67 applicants have been withdrawn, totally disqualified or if FSA has simply identified problems that have set the applications back in the process.

CBD companies that had products on the UK’s gray market as of Feb. 13, 2020 were required to file their applications for new (or “novel”) CBD foods by the end of March this year or remove the products from the market.

Among the 800+ applications submitted so far, roughly 500 remain to start the process and are considered in progress in one way or another, FSA has indicated. The 250 applications which remain under active consideration have passed through early stages of the approval process.

Reporting restricted

In reporting its most recent decisions, FSA also said it will no longer distribute a list or explanations for products which are disqualified, as it had originally indicated it would do. The agency said it will now report only monthly figures for total applications and for applications that are still actively being considered.

Like the EU, the UK’s FSA has determined that food products containing CBD are subject to novel food safety standards, which must be met before new products can go on the market.

Applications to put novel foods on the UK market first go through an administrative check to make sure the documents are complete and in order; a validation phase then assures the product meets requirements for safety based on toxicological analysis, before final assessment.

Deadline looms

Stakeholders said this week it looks unlikely FSA will meet its end-of-June deadline for consideration of the 800+ applications it had received by the March cutoff date, and criticized the agency for the manner in which it has handled the approval process that led to the disqualifications that took place in May.

“This is basically unfair on many of the companies who have spent many thousands of pounds adhering to the FSA’s guidelines,” Greer Deal, an advisor to novel food applicants at consultancy Global Regulatory Services, told BusinessCann, the UK cannabis industry website.

Deal said it is critical that the FSA deliver clear information on a regular basis so that companies know the status of their novel food applications for business planning purposes.

“The CBD ingestible industry is ‘wobbly’ at best at the moment and with this type of unclear feedback, people are bound to interpret it negatively. It is certainly leaving many in the industry in a state of high anxiety and vexation,” Deal said.

Ongoing criticism

As applications move through the FSA’s novel food approval process, rules for CBD in the UK that are still being shaped have drawn broad concern among companies operating on the market, which a recent study said could hit £690 million (€800 million) in 2021.

Key stakeholder groups said last month that proposed rules in a recent safety review before the government, if adopted, would be a “disaster” for the UK hemp industry, specifically critcizing a recommendation that would set a THC limit of 0.03% in finished hemp food and supplement products.

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