 agreement to cover the switch, which would apply to all novel foods, by mid-2027.){kind=link}
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.
This is primarily because UK regulators (the Food Standards Agency, FSA), worked with a daily CBD intake of 10 mg. However, in February, European Food Safety Authority experts (EFSA) cited ongoing safety concerns and suggested a threshold much lower, around 2 mg. Participants have stated that CBD at low levels would be too weak for most products to produce any significant effect.
The figures do not represent fixed safety limits, but rather working assumptions which guide the way each regulator assesses risks and evaluates 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.
Line up with EU
A letter sent by the FSA to Food Standards Scotland on March 12, addressed to CBD members, stated that the UK Government aims to have a SPS agreement in place to deal with the transition, and would cover all novel food, before mid-2027.
While it said that it would assess CBD applications in the future, the FSA told businesses applying to do so to work under the assumption the UK would eventually align itself with the EU. In the letter it was stated that “a large number of applications within the FSA/FSS Market Authorisation Service is unlikely to be approved by the Minister before the Agreement comes into effect.”
Upcoming
• PART 2The European CBD model has unraveled from a gray market into a bottleneck
• The Third PartCBD is facing consolidation in Europe, as the rules change who survives
Hemp Hound (a UK consulting firm that advises CBD-related companies) made the letter public recently. It was written by policy officers Rebecca Sudworth & Garry Mournian.
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 is the EIHA’s Managing Director. He said that the group believes applications already in progress will be accepted before the changeover expected next year. EIHA projects GmbH is a consortium that was organized by the Association. It has submitted two portfolios to the FSA, which cover CBD isolates and CBD full spectrum. Both portfolios include more than 4,00 total products still being considered.
Under the consortium, one dossier can cover entire product “portfolios,” with standardized formulations standing in for dozens—or even hundreds—of individual products.
Mirizzi stated that “our isolate has passed risk management, and we are at the final public consultation for a recommendation minister and a ministerial authorisation” in UK. Mirizzi said that the other portfolio of products from the consortium, which includes full spectrum CBD, is currently under review by FSA.
EIHA has formed a consortium that will develop food safety applications both for the UK and EU systems. As a result, the products of the members are currently being reviewed by EFSA.
The EIHA portfolios are responsible for approximately 4,000 of the products available in the UK market. However, there is a large number of products that fall into a smaller grouping. 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.
More than 700 of the 12,000 products that were submitted to the UK Novel Food Approval Process since the CBD process was opened in 2022 have been removed, either by the applicant or the agency.
Number 2 of the Letter 2
FSA later stated (March 23), in a letter addressed to “Dear All”, that they “have committed to making recommendations for GB ministers this year, on three applications subject to consultation in 2025.” The FSA has also agreed to develop draft recommendations for risk management on another group of applications that have received positive safety evaluations.
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.
If the SPS agreement is delayed, products that are approved for sale in the UK may be temporarily formulated to adhere to a daily limit of 10mg. However, the standard adopted by the EU will ultimately apply.
Slight differences
Both the UK and EU treat CBD as an innovative food issue, though they work in slightly different ways. The UK’s Food Standards Scotland and the FSA review applications, which are then used to formulate risk management recommendations. These can be made public for consultation prior to ministerial approval.
In the EU the European Commission is responsible for managing the process. EFSA gives the scientific advice, and the member states approve the Commission’s implementing act, which adds a approved product to the Union listing.
Confusion, delays
The UK’s process was marked by delays, confusion, and rejections. Early in 2022, the regulators placed certain products on the public list, while forcing others to leave the process. As a result, a large part of the market was left without a clear view of full approval. The frustration grew later over the slow review process and system, which kept businesses in an uncertain state of affairs while officials decided on what products to keep on the market.
Recently, there have been questions about how the FSA handles filings.