After years of uncertainty, many CBD makers with products in the UK food-safety pipeline are being pushed toward a stark commercial crossroads — continue investing under shifting assumptions, or cut losses before a final answer ever arrives.
As UK officials seek an agreement to revert to the EU food-safety system – an idea first floated nearly a year ago – more than half of CBD products in the UK pipeline could be overtaken by stricter EU rules, undermining their original economics.
Most importantly, diverging UK and EU safety assumptions could leave many to decide whether continued participation – and investment – still makes sense.
That’s mainly because UK regulators, the Food Standards Agency (FSA), have worked around a 10-mg daily intake level for CBD, while European Food Safety Authority (EFSA) experts in February pointed to a much lower threshold of about 2 mg, citing ongoing safety concerns. Stakeholders have said that low level will would leave most CBD products too weak to have any meaningful effect.
These figures are not fixed limits but working safety assumptions that guide how each regulator evaluates risk and reviews applications.
While the EU’s leading hemp trade group, the European Industrial Hemp Association (EIHA), has said it is committed to working with EFSA and the European Commission to raise the limit, the switch could make some applicants simply give up – seeing no end to an already painfully prolonged process.
Lining up with EU
According to a March 12 letter from the FSA and Food Standards Scotland (FSS), sent to some in CBD circles, the UK government aims to implement a sanitary and phytosanitary (SPS) agreement to cover the switch, which would apply to all novel foods, by mid-2027.
While the FSA said it will continue assessing CBD applications, it told applicant businesses to operate on the assumption that the UK will eventually align with the EU. According to the letter, “a substantial number of applications in the FSA/FSS Market Authorisation Service are unlikely to reach the point of ministerial decision before the Agreement is in place.”
UPCOMING
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• PART 3: CBD in Europe faces consolidation as rules reshape who can survive
The letter, from policy officers Rebecca Sudworth and Garry Mournian, was recently made public by Hemp Hound, a UK consultancy that has advised CBD companies.
A shift toward the EU track would likely mean further costs — not necessarily a full new toxicology program in every case, but at minimum a new regulatory strategy, an EU-facing dossier and, for some, added studies or other data work needed to meet EFSA’s requirements.
EIHA dossiers
Francesco Mirizzi, EIHA Managing Director, said his group expects that applications which are well-advanced in the UK pipeline will be approved before the anticipated changeover next year. EIHA projects GmbH, a consortium organized by the Association, has two portfolios before the FSA that cover isolate and full-spectrum CBD. The two portfolios cover more than 4,000 total products that are still under consideration.
Under the consortium, one dossier can cover entire product “portfolios,” with standardized formulations standing in for dozens—or even hundreds—of individual products.
“Our isolate passed the risk management and is at the end of the public consultation to receive a recommendation to minister and eventually a ministerial authorization” in the UK, Mirizzi said. The consortium’s other portfolio, carrying full-spectrum CBD products, is now under FSA’s risk management review.
EIHA put together the consortium to develop applications for both the UK and the EU food safety systems, so members’ products are already under review by EFSA.
While EIHA-backed portfolios account for roughly 4,000 products in the UK system, the remaining 7,000 or so products are spread across a fragmented set of smaller applications. It’s those applicants who will face the greatest dilemma: Invest further to enter the European review – hoping rules will eventually make the business viable – or bow out of the market altogether.
Of the roughly 12,000 total products entered in the UK novel food approval process since it opened for CBD in 2022, more than 700 products have already fallen out, either removed by the applicants or disqualified by the agency.
Letter No. 2
FSA said in a later (March 23) “Dear All” letter that “We have committed to making recommendations to GB ministers later this year on three applications which were subject to public consultation in 2025. We have also committed to developing draft risk management recommendations on a further group of applications for which positive safety assessments have been published.”
At the same time, that letter, from Chris Stockdale, Head of CBD Policy at FSA, urged applicants to verify that their products fully match the applications they are linked to — a signal that any eventual authorizations will be tightly defined and enforced, no matter which system they may ultimately pass through.
Any delays in reaching the SPS agreement might mean products approved in the UK could be formulated for a 10 mg daily intake limit temporarily, but whatever standard is adopted for the EU will eventually apply.
Slight differences
The UK and EU systems both treat CBD as a novel food question, but work slightly differently. In the UK, applications are reviewed by the FSA and Food Standards Scotland, with safety assessments feeding into risk-management recommendations that can be opened to public consultation before ministers decide on authorization.
In the EU, the European Commission manages the process, EFSA delivers the scientific opinion, and member states vote on a Commission implementing act that adds an approved product to the Union list.
Confusion, delays
The UK process has been marked throughout by confusion, rejections, shifting standards and delays. In early 2022, regulators advanced some products on a public list while forcing hundreds of others out of the process, leaving much of the sector without a clear line of sight to full authorization. Frustration later grew over slow reviews and a system that left businesses in commercial limbo while officials sorted out which products could remain on the market.
More recently, questions persisted over how the FSA handled filings and whether the process delivered the transparency and legal clarity the market had been promised.