It is likely that companies who have invested thousands of pounds in the safety review conducted by the UK for CBD will find it difficult to get approval before next year, when the EU regulatory control system takes over.
Some producers have been forced to stop submitting their novel foods for UK consideration due to high costs, lengthy timelines and changing requirements. Others have closed down while waiting.
The UK experience
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.
The Food Standards Agency established in 2020 a new food pathway that would allow products linked with validated applications on the market, while they were undergoing a safety review. The Food Standards Agency (FSA) established a novel food pathway for CBD in 2020, which allowed products linked to validated applications to remain on the market while undergoing safety review.
It was an immediate response. In anticipation of approval, hundreds of companies invested heavily in regulatory strategies, legal support, data and other resources. Analyses at the time revealed the magnitude of the initial rush, as the number of products awaiting preliminary approval reached thousands.
It is important to have the right idea
In the end, the UK approval system would be dominated by two consortiums as the products increased. In shared dossiers, the European Industrial Hemp Association, or EIHA, covered more than 4,500 of 12,000 products in CBD isolate and CBD full spectrum, all under the EIHA projects GmbH, a closely related company.
A UK-based trade association, the Association for the Cannabinoid Industry(ACI), organized a second batch of packaged products that brought thousands more into the FSA.
THIS SERIES
• PART 1: The UK switching to EU Food Safety Rules could lead to the death of thousands CBD products
• PART 2The CBD bottleneck in Europe tightens, as the UK’s regulatory pathway stagnates before EU handover
• Part 3CBD faces consolidation in Europe as new rules determine who will 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.
Consortia were on the right track with their strategy to build shared assets in science and standardize ingredients. But mounting – and sometimes dubious – safety concerns have cast a shadow over not just the UK, but the entire European CBD landscape.
Scientific stall
As regulators have become more conservative, the UK system is moving in an uneven manner. Over time, guidance regarding daily CBD consumption has tightened. The Medicines and Healthcare products Regulatory Agency, (MHRA), in 2017 indicated an informal daily CBD intake of 200mg. This was a time when the FDA had little guidance and CBD wasn’t fully defined as a food-safety component.
This dropped to 70mg per day by 2020, under Food Standards Agency rules. CBD was included in novel food regulations and the focus shifted from short-term to long term use.
In 2023 the FSA reduced its recommendation to 10mg/day, due to concern about liver effects, cumulative exposure, and possible side-effects.
A death knell?
The parallel EU process is at a standstill since EFSA halted its evaluation of CBD novel foods applications in 2022. This was due to potential adverse effects on the liver and gastrointestinal system as well as the nervous system, endocrine system, and psychological wellbeing.
Contrary to the UK system which permitted products to be linked to specific applications, the EU path requires an opinion on safety before the product is commercialized.
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? The industry’s good-faith efforts are also put to the test. European hemp supporters played by the rule, spent millions of dollars, gathered safety data, and used official channels to create a viable, legitimate and safe market. The failure of the hemp industry will result in not only massive financial losses but also loss of many products which consumers claim improved their quality of life and health.
The real tragedy is that.
SEE: The Food Standards Agency Open Letter