Roughly 650 of 800-plus CBD food safety applications have been rejected by the UK’s Food Standards Agency (FSA) amid a slowdown in the new approval process that has rattled stakeholders in the sector.
Six months after it set its initial deadline for compliance, the FSA is still unable to say when it will publish its final, complete list of validated CBD suppliers and products. The agency said it is still processing 213 applications but progress has slowed due to the complexity of many of those filings.
4 companies get edge
Meanwhile three UK companies and one from the Czech Republic are the only producers that “should be allowed to stay on the market until a decision on their authorisation has been made,” according to the FSA.
A total 43 products that have received provisional approval include those from Rokshaw Laboratories, UK (20 products); Chanelle McCoy Health, Ireland (11 products); CANNABIS Pharma, s.r.o., Czech Republic (6 products); and Health Innovations Ltd., UK (6 products).
Stakeholders with pending applications have said they could go out of business as retailers have frozen their plans for stocking CBD products – putting a plug in the supply chain – pending the FSA’s final list.
Like the European Union, 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 may be sold. In the case of CBD, which has flooded the market in the UK and across Europe amid unclear laws and rules, UK regulators are determining which of those products are market-worthy and may remain on sale.
CBD companies that had products on the UK’s gray market as of Feb. 13, 2020 were required to file their applications for novel CBD foods by the end of March this year or remove the products from the market. The approximate 650 products which failed the process will be targeted by enforcement officials of UK Trading Standards if they are not removed, FSA said. The products were rejected because their applications were either incomplete or invalid; others were withdrawn by the applicants, according to the agency.
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.
Other stakeholder concerns
In addition to the UK’s clogged 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) this year.
Most importantly, stakeholders are pushing back against recommendations in an earlier CBD safety review that would set a THC limit of 0.03% in finished hemp food and supplement products and classify CBD products containing between 0.03% and 0.2% cannabinoids under Schedule 5 of the country’s Misuse of Drugs Regulations act.
Of the companies whose CBD products are provisionally approved, Rokshaw Laboratories, Sunderland, UK makes over-the-counter health aids; Chanelle McCoy Health, Galway, Ireland, which holds the Pureis CBD brand, is the producer of a range of own-brand CBD capsules and oils; Cannabis Pharma s.r.o, daughter company CBDepot, and 4MP Technologies, Chichester, England, are co-applicants; and Health Innovations, North Yorkshire, is a maker of solid dose nutritional supplements.