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The UK novel foods approval process for CBD products is now complete.

The UK’s long-running CBD (cannabidiol), products regulation project has taken a significant step forward.

Food Standards Agency, FSA, announced today that they will hold a public 12-week consultation for the review of 3 applications, representing nearly 3000 CBD isolat products.

After almost a decade, this marks the final step towards the UK becoming the first country to officially regulate the non-intoxicating cannabis extract, in what the European Industrial Hemp Association (EIHA) called ‘a crucial milestone confirming the safety profile of hemp-derived CBD’.

This comes only six weeks following a meeting of the FSA’s new board with stakeholders in the industry to discuss the plan of action it would take to advance the process. It is a promise the FSA has kept so far.

Novel foods reach their final approval stage

Three applications have now passed the ‘risk management’ phase, meaning that the FSA is preparing to make recommendations to government ministers to officially authorise these products for sale, becoming the first regulatory body in the world to do so.

Last year, these three dossiers – RP07 RP350 RP427 – were the first that passed through the phase of risk assessment. The first two dossiers received positive safety evaluations in April and RP427 in August.

Chanelle Mccoy, Pureis producer, stated in a recent press release that “this progress is the result of a decade’s worth of work and investment into a suite of Safety Clinical, and Toxicology Studies to support their Novel Food Application, since it was first submitted in January 2020.

Read More: FSA shifts gears – Reformulation, Tolerance of THC, and faster CBD approvals appear to be on the horizon

The company’s namesake, founder and CEO said she ‘commends the FSA’ and that this work has set a ‘new global standard’ for CBD regulation, which she hopes can be replicated across the world.

Daniel Kruse commented, “Years spent in coordinated research and investments have brought us this far.” Cooperation works. The safety assessment was completed and we are now moving into risk management. “At the same time the next months will be critical: details are important, and we have to ensure that this framework supports both the industry and the consumers.”

    • Chanelle McCoy / Pureis
    • RP07
    • Buy 11 Products
    • Cannaray
    • RP350
    • There are 43 items.
    • EIHA Consortium
    • RP427
    • Buy 2718 Products

 

Public consultation phase: ‘The details matter’

The FSA launched a public consultation on August 28th 2025. This 12-week period will help shape key aspects of the government’s request for approval.

It is the critical stage of the CBD process, which will influence the future regulatory path for CBD and possibly other countries.

This will be a desperate attempt to resolve some issues, as many approval stipulations are still highly contentious.

The FSA has sent a draft recommendation on risk management to each of the three applicants.

The consultation, which will take place over the next three-month period, will aim to determine the conditions of authorization, including the permitted food categories and 10 mg/day as the acceptable daily intake.

As Francesco Mirizzi, Managing Director of EIHA, noted: “It is… important to underline that the consultation period will be key: we will raise a number of points to ensure that the final authorisation, definition and conditions for CBD novel foods are fit for purpose, viable for businesses, and safe and transparent for consumers.”

Food Standards Scotland’s (FSS), which launched a consultation on 28 August and is open to the public until 20 November, 2025, seeks comments on three applications. The FSA will be contacting food companies, trade associations and enforcement agencies, as well as consumer groups, in England, Wales, and Northern Ireland.

Read More: UK’s FSA Softens Stance On 0% THC In CBD Products As MHRA Draws Clear Lines on CBD Medical Claims

This consultation is seeking views and evidence about the potential economic impacts or benefits of CBD-containing foods, as well as the possible terms for authorisation.

The Windsor Framework allows authorised CBD food products to be sold in Northern Ireland via the Northern Ireland Retail Movement Scheme. However, NI-based companies are not permitted to produce their own CBD food.

Email or online surveys are available from the FSA. The FSA will then publish the summary within 3 months. This information is used to make final recommendations before authorisations can be granted.

Cannabis Trades Association, which is a group of stakeholders in the cannabis industry, and EIHA have been working together to engage with regulators. They believe that a few key topics will dominate the discussion for the next several months.

  • Daily intake A mg/kg formula could be more precise than the 10 mg/day fixed limit.
  • Products: By limiting approvals only to CBD isolates or synthetic CBD, consumers may be excluded from the wide range of hemp products they prefer and demand could shift to unregulated markets.
  • Labelling: For small packages, full warnings may not be practical. Instead, a model that includes core messages on the pack and additional information through QR codes or leaflets is recommended.
  • Limits for THC: It is not realistic to propose a threshold of 0.00001% due to the testing variance and incompatible with Home Office exemptions for 1 mg/container.
  • Protection of data A five-year exclusivity period could be disadvantageous to SMEs that rely on the Public List. An equivalence path would balance innovation with fair access.
  • Enforcement: Divided responsibilities between local authorities (Novel Foods) and police (controlled substances) create complexity; stakeholders argue for a joint FSA–Home Office protocol.

The Ministers of England, Wales and Scotland, once the consultation has ended and the conditions for authorisation established, will decide whether or not to accept the applications.

The regulatory reforms that came into effect in April 2025 have made it so that ministerial decision are immediately effective and published on official lists of approved products. Secondary legislation is no longer needed to delay the implementation.

There are many questions surrounding the FSA’s transparency and actions. Many companies on the list of public companies have not yet decided whether to move forward or reformulate. This option was only announced last week.

In the long term, even if an official regulatory pathway is established, there are still many questions about how new market players could enter.



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