The UK’s first-ever CBD product authorisations, originally expected to be completed by Autumn 2026, could now face another setback as Food Standards Scotland (FSS) insists on holding its own consultation.
This new consultation, revealed in correspondence between the Cannabis Trades Association (CTA) and the FSS, seen by Business of Cannabis, stems from the UK’s devolved food safety structure. While the FSA closed its 12-week consultation for England, Wales, and Northern Ireland in November, the FSS confirmed that it will launch its own consultation in early 2026.
Because both agencies operate on a ‘four-nation basis,’ the three isolate CBD applications already cleared for risk management (RP07, RP350 and RP427) cannot proceed to ministerial approval until Scotland’s process concludes and all agree on a unified position.
Following a welcome period of meaningful progress over 2025, seeing a new management team inject fresh energy into the long-stalled process, this has caused concern among the industry that further delays could be incoming.
In response to these concerns, the CTA has published a sweeping 43-page proposal for a new regulatory framework that would scrap the uniform 10mg daily limit and replace it with a three-tier system rewarding companies with robust toxicology data with higher permissible intakes.
Regulators Defend Timeline, Acknowledge Risks
When asked whether Scotland’s separate consultation would delay the anticipated autumn 2026 timeline for ministerial approval, both agencies maintained that their target remains achievable.
The FSA told Business of Cannabis that it does not consider the FSS consultation to represent a significant delay, stating it is currently reviewing responses and remains on track to take recommendations to ministers in autumn 2026.
However, the agency acknowledged that external dependencies, including four-nation alignment, could impact timelines, while confirming it does seek alignment with Food Standards Scotland before the three applications can proceed to ministerial sign-off.
Food Standards Scotland was more cautious in its framing. When asked about the timeline for Scottish ministerial recommendations, FSS said, ‘it is a complex area, and the earliest FSS could make recommendations would be autumn 2026.’
The Scottish regulator also confirmed the consultation will cover ‘broader food law matters such as food supplements and nutrition requirements’, not just the three final stage dossiers.
Furthermore, it said it ‘intends to launch its consultation in early 2026 for 12 weeks,’ meaning the consultation could conclude in late March or April. FSS stated that ‘the FSS consultation and the work done by the FSA will inform recommendations made to Ministers in GB in due course,’ confirming the dependency between the two processes.
On the question of May’s Scottish Parliament elections, raised as another potential speedbump in the process, FSS said ‘a change in administration would not affect FSS’s role in providing independent and impartial advice to Scottish Ministers’, but conceded that final Ministerial approval was out of its hands.
In response, the CTA reiterated their support for the new FSA management team, and the progress they have made over the last year.
The SPS Complication
In July, Business of Cannabis reported on the potential implications of UK-EU Sanitary and Phytosanitary Standards (SPS) negotiations for the CBD sector, warning that alignment with EU food regulations could undermine the FSA’s six-year regulatory programme.
At the time, industry sources had hoped UK authorisations would be completed before SPS negotiations concluded, establishing a regulatory standard that would allow the UK to negotiate an exception for CBD under any future agreement. However, these new delays make this scenario increasingly unlikely.
Under the SPS proposals, the UK would adopt a ‘dynamic alignment’ mechanism, automatically following relevant EU rules for agrifood products. While the FSA is still pursuing the world’s only active CBD novel foods programme, the European Food Safety Authority (EFSA) effectively ‘stopped the clock’ on its 19 CBD applications, citing ‘many data gaps’ on human health effects, with almost no progress since.
There are three potential outcomes of these negotiations in regards to CBD:
- 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.
The European Commission has outlined that any UK exception would require: standards no lower than EU levels, no limitation on EU imports to UK, and only EU-compliant goods permitted to enter EU markets.
For companies that have invested heavily in UK applications for over six years, the prospect of regulatory authority shifting to the stalled EFSA process represents a worst-case scenario.
“Worse still is the SPS negotiations between the UK and EU for Foods, which will now likely include CBD foods and supplements all under the EFSA (European Food Safety Authority), which we were hoping to avoid by getting UK sign off for the three Isolated CBD dossiers prior to the broader negotiations,” the trade body warned its members in December.
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Industry Trade Body Proposes Three-Tier Framework
In response to the delay, the CTA has published a 43-page proposal that would reshape UK’s current CBD regulatory framework by replacing the controversial blanket 10mg daily limit with a tiered system based on evidence quality.
The framework, compiled by the trade body’s scientific advisors alongside executive directors Marika Graham-Woods and Sian Phillips, explicitly ranks existing CBD applications into three categories, naming companies and their dossier reference numbers.
The framework’s tier classifications are based on the CTA’s analysis of publicly available FSA and FSS safety assessment documents, which detail the type and depth of toxicological evidence submitted by each applicant.
Under Tier 1, applications backed by comprehensive GLP toxicology studies on their own material, 24-month stability data, and extensive contaminants testing would be permitted 15mg daily intakes, potentially rising to 24mg with additional human data. TTS Pharma (RP521) and Bridge Farm (RP354) currently qualify for this category.
Tier 2 maintains the current 10mg limit for applications with adequate but less comprehensive data, such as CBDMD (RP793), with a pathway to upgrade through submission of additional studies.
Tier 3, dubbed ‘Legacy/Minimal Evidence’, would restrict early applications that relied primarily on published literature to 10mg limits and bar them from white-label manufacturing. The EIHA consortium dossier (RP427), Cannaray (RP350), and Pureis (RP07) fall into this category, with companies given a six-month window to either switch to Tier 1 suppliers or cease ingestible CBD sales.
All three Tier 3 applications, including EIHA’s RP427, have received positive safety assessments from the FSA, the tier classification relates to evidence methodology rather than safety outcome.
“Later submitted, higher-quality dossiers have been held to the same limit despite providing far superior toxicological and stability evidence,” the proposal states. “A dossier-specific approach is therefore scientifically justified and legally required under Regulation 2015/2283.”
The proposal also introduces an ‘Article 4’ route for traditional cold-pressed hemp seed oils containing no more than 0.2% CBD and delivering under 2mg daily, classifying them as non-novel foods exempt from the authorisation process entirely. This would create a separate regulatory lane for culinary oils while focusing Novel Foods oversight on higher-dose supplements.
To address international trade concerns, the CTA proposes a ‘Molecular Equivalence Certificate’ system requiring imported CBD isolates to match UK/EU Tier 1 specifications regardless of their source plant variety. The measure aims to level the playing field between UK producers restricted to approved hemp varieties and overseas suppliers using higher-yield cannabis strains.
All products would face new transparency requirements: mandatory country-of-origin labelling, declaration of natural versus synthetic CBD, QR codes linking to batch certificates of analysis, and full farm-to-shelf traceability. A public FSA register would display each product’s tier classification, permissible daily intake, and dossier reference.
“The tiered system restores full compliance with the Regulation’s intent, authorisation and intake limits reflect the applicant’s own evidence,” the proposal argues, citing precedents from other novel food categories including phosphatidylserine, astaxanthin, and plant sterol esters, all of which began with applicant-specific authorisations before later harmonising once sufficient evidence supported it.
The proposal has already drawn pushback from EIHA, whose consortium dossier the CTA places in Tier 3.
Managing Director Francesco Mirizzi told Business of Cannabis the CTA ‘does not have access to the underlying novel food applications’ and that EIHA’s application ‘was prepared according to the highest OECD standards,’ adding that the Tier 3 classification is ‘unjustifiably negative’.
The CTA’s proposal, whether adopted by regulators or not, points to exasperation within the industry over a process that has now consumed staggering levels of resources and time, and still has no guaranteed endpoint in sight.
