As part of the FSA’s re-energised efforts to push forward with the long-running CBD novel foods approvals process, the agency has continued to actively liaise with industry stakeholders regarding their applications.
Under its largely overhauled new leadership, earlier this month the FSA provided some long-called-for clarifications on THC limits, ADI guidance, and prospective timelines for businesses still waiting for their products to be officially approved by the regulators.
However, attention and communication has now shifted to the Starmer administration’s efforts to secure a Sanitary and Phytosanitary (SPS) agreement with the European Union, with a view to boosting trade with the UK’s closest trading partners.
These complex negotiations are still in the early stages, but depending on the outcome, they could see the UK more closely align with EU regulations on CBD.
While this could open up the EU market for UK-based CBD businesses, it could also push the process back even further given the union’s current state of inaction.
What is an SPS Agreement?
An SPS Agreement is a type of international treaty that governs how countries apply health and safety regulations to protect humans, animals, and plants while preventing such rules from becoming hidden forms of trade protectionism.
Overseen by the World Trade Organization (WTO), the SPS framework encourages countries to harmonise their rules with international standards, but does allow for flexibility to go beyond those standards if justified by scientific evidence.
In May, the UK and European Commission met in Brussels for ‘exploratory talks’ into potential future bilateral trade and alignment, part of Starmer’s so-called ‘Brexit reset’ initiative.
No concrete agreements were made during the meeting, but the groundwork was laid for future, more detailed negotiations into a number of areas, including an SPS Agreement.
Proposals now on the table would see checks on plant produce, and other agrifood items removed, but both sides would rely on a ‘dynamic alignment’ mechanism, seeing the UK automatically adopt relevant EU rules.
The UK could request limited exceptions to alignment, but only if:
- a) It doesn’t lower standards,
- b) It doesn’t disadvantage EU products in the UK market,
- c) It doesn’t compromise EU import rules.
What does this mean for CBD?
For all its missteps, the FSA’s CBD novel food programme remains the only one in the world working to regulate CBD as a food.
In Europe, the European Food Safety Authority (EFSA) effectively ‘stopped the clock’ on the 19 European novel foods applications currently under consideration until ‘many data gaps’ on the health effects of CBD in humans have been filled.
Since then, almost no progress has been made on the part of the EFSA, who have called for more data, including human toxicology studies, to determine the safety of CBD.
This puts the UK and EU’s CBD regulations at odds with each other, and despite efforts to edge the process towards official approvals in the UK, a comprehensive alignment with the EU could put the entire industry back to square one.
There are three potential outcomes of these negotiations in regards to CBD, though it’s worth noting that these are expected to be years away, and will not immediately impact the ongoing work on the public list and novel food applications.
- Full dynamic alignment with the EU (no exceptions): The UK would follow EU rules for CBD, and market authorisations would be made by the EU for both the EU and Great Britain.
- Dynamic alignment with some exceptions (including a full exception for CBD): The UK would maintain an independent policy for CBD, and the FSA’s CBD program would continue as planned.
- Failure to reach an agreement: The status quo would continue.
For businesses that have already spent tens of thousands on their UK applications and waited in limbo for half a decade, handing the power back to the EFSA would be a painful twisting of the knife.
The FSA has reiterated its commitment to supporting the CBD market authorisation process.
However, delivering this programme in full, without modification, would require a negotiated exception, an outcome that is ultimately out of its hands.
The EC has outlined three key conditions that would need to be met in order for the UK to secure an exception for CBD products under an SPS agreement.
- First, any such agreement must not result in standards that are lower than those set by the EU.
- Second, it must not limit the ability of EU imports to access the UK market.
- Third, and likely the most difficult condition to fulfil, only goods that are fully compliant with EU regulations would be permitted to enter the EU market.
Even if all three of these criteria were to be met, this would not necessarily guarantee an agreement. The EU is unlikely to offer the UK any deal it perceives as conferring a competitive advantage over its own member states.
While it remains difficult to establish a clear timeline for when negotiations might begin, the UK government is reportedly aiming to secure an SPS agreement as soon as possible, with talks expected to commence within the next year. Any agreement reached would likely also involve a significant transition period.
Although the FSA has clearly made a conscious effort to keep the industry informed of upcoming developments (not to mention this is out of their control), for CBD business owners this will create yet more uncertainty, complications, and worry.
To better understand the real-world impact of the FSA’s CBD Novel Foods process, the Cannabis Trades Association (CTA) has launched a new industry-wide survey to gather insights from businesses operating in the CBD food sector.
Whether your company is still trading, has scaled back, exited the market, or was affected at any point since 2018, your experiences matter. The findings will be anonymised and used to inform the FSA and other stakeholders, supporting calls for a more balanced and effective regulatory environment.
