Companies that have poured hundreds of thousands into the UK safety review for CBD now face the likelihood that approvals won’t come through the national system before regulatory control reverts to the highly restrictive EU system, expected next year.
High costs, long timelines and shifting requirements have already forced some producers to withdraw their products from novel food consideration in the UK; others have gone out of business waiting.
The UK experiment
The UK’s departure from the EU in 2020 created an opening for what many in the hemp cannabinoids industry saw as a more pragmatic path forward – diverging from the bureaucracy of Brussels.
Beginning in 2020 and formalized in 2022, the Food Standards Agency (FSA) established a novel food pathway for CBD that allowed products linked to validated applications to remain on the market while undergoing safety review. For the first time, CBD companies had what appeared to be a credible route toward legitimacy in a UK market estimated at $850 million to $1 billion.
The response was immediate. Thousands of products were submitted into the system, and hundreds of companies entered the process, many investing heavily in data, regulatory strategy and legal support in anticipation of eventual approvals. Analysis at the time showed the scale of that initial surge, with the number of products tied to preliminary approval reaching into the thousands.
The right concept
Eventually, two consortia would dominate the UK approval system as the number of products doubled. The European Industrial Hemp Association (EIHA) came to cover more than 4,000 of the 12,000 products, in shared dossiers for CBD isolate and full-spectrum CBD, under a related entity, EIHA projects GmbH.
Several thousand more entered the FSA journey through a second group of batched products organized by the Association for the Cannabinoid Industry (ACI), a UK trade group.
THIS SERIES:
• PART 1: UK’s switch to EU food safety rules could push thousands of CBD products to dead end
• PART 2: Europe’s CBD bottleneck tightens as UK pathway stalls before EU regulatory handover
• PART 3: CBD in Europe faces consolidation as rules reshape who can survive
The cost of preparing a single novel food application has been widely estimated at between €350,000 and €500,000 – out of reach for much of the fragmented retail market that had developed in the gray zone. EIHA said it has spent around €3 million to build shared toxicology and safety data backing its applicant CBD products through both UK and EU regulatory systems.
The consortia’s strategy of building shared scientific assets and standardized ingredients was the right direction. But mounting – and sometimes dubious – safety concerns have cast a shadow over not just the UK, but the entire European CBD landscape.
The scientific stall
The UK system has moved forward unevenly, with guidance on daily CBD intake tightening over time as regulators became more cautious. In 2017, the Medicines and Healthcare products Regulatory Agency (MHRA) pointed to an informal level of about 200 mg per day, reflecting a period when there was little clear guidance and CBD had not yet been fully defined within a food safety framework.
That dropped to 70 mg per day in 2020 under the Food Standards Agency, as CBD came under novel foods rules and attention shifted to long-term use in the general population.
By 2023, the FSA lowered its guidance again to 10mg per day, citing concerns about possible liver effects and cumulative exposure.
A death knell?
Meanwhile, the EU’s parallel process has been in a standstill after EFSA paused its assessment of CBD novel food applications in 2022, citing potential effects on the liver, gastrointestinal system, endocrine function, nervous system and psychological well-being.
Unlike the UK system, which allowed products linked to applications to remain on the market, the EU pathway requires a full safety opinion before commercialization.
That scientific barrier has now translated into a stark divergence over what constitutes a viable daily intake level, with EFSA – over-cautiously – pointing to roughly 2mg per day, a sharp contrast from a threshold of 17.5mg proposed by the EIHA, and well below the UK’s 10mg limit.
It raises an existential question: can products built on earlier assumptions make it – at all – in such a tightly regulated market? It also puts years of good-faith industry effort on trial. European hemp advocates played by the rules, invested millions, generated safety data and worked through the official channels to set a guide for a legitimate, safe and viable market. If it all ends in failure, the result will not only mean massive commercial wreckage but also the loss of products that many consumers say improved their health and quality of life.
That’s the real tragedy.
SEE: An Open Letter to the Food Standards Agency