Transparency data

CBD novel food applications: recommendations to ministers on first authorisations

Published 3 September 2026

Applies to England, Northern Ireland and Wales

1. Summary

1.1 This paper discusses recommendations for the authorisation of three cannabidiol (CBD) novel food applications. The recommendations include proposed conditions of authorisation, designed to protect consumers and vulnerable groups, support compliance and enable proportionate enforcement.

1.2 The FSA has been performing the novel food risk assessment process for the first high-purity (≥98%) CBD novel food applications as part of its routine, domestic responsibilities.  The FSA and Food Standards Scotland (FSS) have published positive safety opinions on the first three CBD applications (RP 7, RP 350 and RP 427), which have since been subject to public consultation. We have now considered consultation responses.

1.3 As this is the first time the FSA will recommend the market authorisation of CBD applications, we are seeking confirmation of the board’s support for our risk management approach. While the FSA provides safety and risk management advice on novel foods to ministers in England and Wales, with the Minister for Health in Northern Ireland kept informed, it is Ministers that will make the final decision on authorisations.

1.4 The board will be aware of the ongoing Sanitary and Phytosanitary (SPS) Agreement negotiations. However, assimilated Regulation (EU) 2015/2283 (the “Novel Foods Regulation”) establishes a statutory process for authorisation decisions following completion of the novel food safety assessment. Under the Novel Foods Regulation, the FSA has a duty to provide its opinion on safety to Ministers in England and Wales. While negotiations remain underway, the FSA has continued to progress applications in accordance with the prioritisation principles agreed by the FSA and FSS boards in December 2025.  Considering these first CBD authorisations is consistent with these principles.

1.5 The board is invited to:  

• DISCUSS the outcomes of consultation on the first high-purity CBD novel food applications and the risk management recommendations formed in response.
• NOTE the wider SPS Agreement context on recommendations to Ministers.
• AGREE that the recommendations on the three applications are suitable for presentation to Ministers in England and Wales.

2. Introduction

2.1 The first three CBD novel food applications are RP 7 synthetic CBD, RP 350 CBD isolate and RP 427 CBD isolate. These are ≥98% pure CBD foods and are intended for adults at a maximum dose of 10 mg/day. They were found to be safe under their proposed conditions of use, based on advice from the Advisory Committee on Novel Foods and Processes (ACNFP).

2.2 Subsequently, FSA and FSS risk managers have worked together on how to adequately protect consumers and advise them on safe consumption of these CBD novel foods.  In December 2024, the board considered the principles that should underpin the risk management of CBD novel food applications, agreeing a focus on consumer safety, proportionality, ensuring compliance, supporting enforcement and maintaining consumer trust.  These principles were used to draft the proposed conditions of authorisation.

2.3 The FSA consulted on these risk management proposals for 12 weeks from 28 August 2025.  

The proposals set out that products must be labelled with the provisional acceptable daily intake (ADI) of CBD of 10 mg/day and warnings for under-18s; people who are pregnant, breastfeeding or trying to conceive; and those taking medication or who are immunosuppressed.  We proposed that authorisation should only be granted with strict specifications, including low limits for delta-9-tetrahydrocannabinol (Δ9‑THC) and other controlled cannabinoids.

2.4 We received 46 consultation responses from consumers, applicants, trade associations, industry and local authorities.  Responses indicated support for the overall risk management approach (68% of respondents supported the proposals), while identifying areas where minor changes or clearer explanations were needed.  We have proposed a number of targeted changes and confirm our recommended approach on the key issues set out below.

 These are explored further in the summary of responses, which will be published separately.

2.5 The progress made on these CBD applications represents a major milestone in the regulation of the CBD food sector. Should ministers agree to these proposals, the resultant authorisations will be a regulatory first for Great Britain.

2.6 The CBD Public List was established in England and Wales as an interim measure to help manage an existing CBD market while applications progressed through the novel foods process. 

The FSA advises local authorities to prioritise their enforcement activity towards CBD products not included on the Public List. This does not alter the fact that CBD products remain unauthorised novel foods and enforcement decisions rest with local authorities. 

There are approximately 3,000 individual CBD products linked to these first three applications on the Public List. These recommendations therefore represent a significant step towards moving the CBD market into regulatory compliance, supporting consumer confidence under the novel foods framework.

3. Discussion of key aspects of risk management

THC and other controlled cannabinoids

3.1 We maintain our recommendation that authorised products are subject to strict specifications for Δ9-THC and other controlled cannabinoids, reflecting the need to protect consumers, support enforcement and ensure consistency with wider legal requirements.

3.2 The board should note that we propose a more feasible Δ9-THC specification for application RP 427 following consideration of additional evidence submitted by the applicant during consultation.  This revision reflects a higher Δ9-THC level that can be consistently achieved and verified across production and is in line with our principle for contaminant levels to be as low as reasonably achievable (ALARA).  

It continues to provide very strong protection for consumers while ensuring that the specification is proportionate, enforceable and achievable in practice.

3.3 Consultation responses also highlighted the need for further guidance to support enforcement authorities, particularly in relation to Δ9-THC controls and the interaction between food and drugs legislation. Throughout 2026, we have worked across Government and with local authorities to identify the key issues that FSA guidance will need to address. 

We plan to provide comprehensive CBD enforcement guidance to local authorities in the coming months and will continue to work closely with enforcement partners to ensure it is practical and fit for purpose.

Food supplements

3.4 We maintain our recommendation to authorise the novel foods for use in food supplements for all three applications, reflecting the categories of use requested and assessed for each application. For RP 350, we also maintain the recommendation to authorise for use in additional categories of beverages and confectionery requested by the applicant. 

Authorisation under the Novel Foods Regulation would permit the placing on the market of the specified novel food only where it meets the relevant terms of authorisation, including the stated conditions of use. In England and Wales, food supplements sold as food and presented as such must also comply with the Food Supplements Regulations 2003 (as amended).

3.5 The consultation set out our rationale for recommending authorisation of CBD in the food supplements category, noting that without evidence of a nutritional or physiological effect under the proposed conditions of use, CBD food supplements may not meet the legal definition of a food supplement. 

Some respondents, including a number of individuals and local authorities, questioned whether CBD should be considered a food supplement and expressed concern that our proposal could reinforce misunderstandings about CBD foods.  

Other respondents from industry and applicants recognised that many consumers purchase and use CBD products in food supplement formats and that the category provides an additional framework for labelling and enforcement.

3.6 We concluded in the consultation that the recommendation to authorise CBD in the requested category of food supplements is reasonable, particularly since consumers generally recognise CBD products as food supplements. The consultation did not present any new evidence or information that would warrant a change in this approach, and therefore we are maintaining our recommendation.

3.7 Existing prohibitions on health and medicinal claims for CBD foods will continue to apply.  Only authorised nutrition and health claims that are included in the GB Nutrition and Health Claims Register can be used on foods and there are no authorised claims for CBD products. 

Food supplements policy is devolved and decisions relating to the regulation of food supplements ultimately rest with DHSC in England and Welsh Government in Wales.

Labelling

3.8 We have revised our recommendation on labelling requirements in the terms of authorisation in order to provide clearer and more concise wording on the ADI.  We recommend that this is presented alongside warnings for under-18s and other vulnerable groups to mitigate against consumption by these groups.  Consultation responses broadly supported the principle of mandatory safety information but identified concerns regarding the length and readability of the proposed statement.  The revised wording (provided in the Summary of Responses) is intended to improve consumer understanding of how much CBD they can safely consume.  Any products linked to the applications will legally need to comply with any conditions of use imposed by Ministers as part of an authorisation.

Data protection

3.9 All three applicants have requested data protection of proprietary data provided in support of their applications.  We will provide advice to Ministers confirming whether the FSA considers the conditions for data protection to be sufficiently met.  Where they are, the novel food is authorised for placing on the market exclusively by the applicant for a five-year period, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary data or with the agreement of the applicant.

Future risk management considerations

3.10 Since concluding and publishing safety assessments on these three applications, the FSA and FSS have continued to assess additional CBD novel food applications.  To date, the FSA has published 14 positive safety assessments for >97% pure CBD novel foods.  Future applications will continue to be assessed on a case-by-case basis, with any previous risk management conclusions applied when supported by the evidence and appropriate in the circumstances.

4. Discussion of wider considerations

Four-country working

4.1 The FSA will provide advice to Ministers in England and Wales, with the Minister for Health in Northern Ireland kept informed.  Board members should note that under Windsor Framework arrangements, businesses must apply to the EU to place regulated products on the market in Northern Ireland.  

CBD novel foods authorised in GB may also be placed on the NI market as retail goods, provided they are eligible for, and are moved through, the Northern Ireland Retail Movement Scheme (NIRMS). 

4.2 FSS has concluded their consultation on the same applications and is responsible for providing advice to Scottish Ministers.  We have shared our proposed recommendations with FSS officials and continue to work towards a consistent approach across Great Britain.  While authorisation decisions are a matter for Ministers in each administration, established arrangements under the Food and Feed Safety and Hygiene Common Framework provide mechanisms for managing any divergence, should it arise.

SPS agreement

4.3 Detailed negotiations with the EU on a UK-EU SPS Agreement are underway.  The proposal for dynamic alignment would mean that, once an SPS Agreement is in place, an EU market authorisation would be required to market novel foods, including CBD, in GB.  However, the EU has accepted there may be a limited number of areas where the UK will need to retain its own rules (referred to as ‘exceptions’).  

In the absence of any exception, businesses would no longer apply to the FSA/FSS for novel food authorisations and would have to apply under EU legislation instead.  EU authorisations would in future cover the whole of the UK and GB authorisations would cease to apply. 

We remain committed to supporting the CBD industry in moving towards regulatory compliance and to keeping applicants and wider stakeholders informed and engaged as plans for an SPS Agreement take shape.

4.4 The European Food Safety Authority (EFSA) has not yet published any positive safety assessments of CBD novel foods. In February 2026, EFSA published an updated statement on the safety of CBD, which sets a safe CBD dose of 0.0275 mg per kg of body weight per day (approximately 2 mg/day for a 70 kg adult).  

The provisional safe level applies solely to food supplement formulations containing CBD with a purity of at least 98%, without nanoparticles, and for which the production process is deemed safe and genotoxicity has been excluded.  For individuals under 25 years old, pregnant and lactating women, and those on medication, EFSA’s scientists concluded that the safety of CBD has not been established.

4.5 Whilst EFSA’s and the FSA’s provisional safe levels differ and are based on different datasets, they involved considerations of the same adverse effects and safety data gaps.  We remain confident in the FSA’s provisional ADI of 10 mg/day, which has been produced in line with established risk assessment principles and with the use of independent expert judgement.

4.6 In March 2026, the European Chemicals Agency (ECHA) Risk Assessment Committee adopted an opinion recommending that CBD be classified as a Category 1B reproductive toxicant and lactation toxicant (“may damage fertility or the unborn child and may cause harm to breast-fed children”) under the EU Classification, Labelling and Packaging (CLP) Regulation, following a proposal by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES).

 The recommendation remains subject to a decision by the European Commission and does not itself determine whether CBD food products may be authorised.  The FSA previously reviewed the evidence underpinning the ANSES proposal and concluded that it did not present new data requiring revision of the FSA’s provisional ADI for CBD.  

However, our advice remains that people who are pregnant, breastfeeding or trying to conceive should not consume CBD.  We will continue to monitor developments and consider any new evidence as part of our ongoing work to ensure consumer protection.

5. Conclusions

5.1 We recommend that the FSA now advises Ministers in England and Wales to authorise the three high-purity CBD novel foods, subject to the proposed conditions of authorisation. The applications have been assessed as safe under their proposed conditions of use, and the recommended risk management approach is designed to follow our agreed principles for CBD. Thorough consideration of the risk management approach for these novel foods has led us to conclude that authorisation would be the most effective way to improve consumer safety and start bringing the CBD market into compliance.

5.2 Subject to the board’s agreement, officials will finalise the ministerial advice package for submission to ministers in England and Wales as soon as possible.  The final decision on whether to authorise the novel foods, and on any associated conditions of authorisation, rests with Ministers following consideration of the FSA’s advice.