Annual Report 2024 (Jan 2024-March 2025)

Dear Reader,

I am delighted to present the yearly report of the Advisory Committee on Novel Foods and Processes (ACNFP). This report summarises the work of the ACNFP, as part of the FSA regulated products process, which covers the financial year of 1st January 2024 until 31st March 2025. This financial period has seen the ACNFP continuing to review the safety of a range of novel food and products of Genetic Modification (GM) at the forefront of food innovation, and in world-leading areas. This has included new discussions, scoping the ACNFPs approach to reviewing the rise in innovative alternative proteins and newly emerging Cell Cultivated Products (CCPs).

In 2024 and until March 2025, this period has continued to see significant progress towards the use of precision bred organisms (PBOs) in food and feed, following the Royal Assent of the Genetic Technology (Precision Breeding) Act on 23 March 2023. Discussions at the FSA board, commensurate with the world-leading approach being taken on PBOs, were informed by the publication of the ACNFP PBO statement in September 2023, supporting a tiered approach to safety evaluation. A significant amount of work of a challenging nature was completed by the ACNFP, and especially its Products of Genetic Technologies (PGT) expert sub-committee, that advised on the types of data that would be important for safety evaluation. In 2024, ACNFP continued their support for the development of the framework for Precision Bred Organisms (PBOs). In 2024, ACNFP and its sub-committee conducted a peer review of new technical FSA guidance for PBO assessments, a first for FSA, and to support the laying of the draft secondary legislation for precision bred plants used for food and animal feed in 2025. Subsequent FSA publication of the guidance took place successfully in early 2025 along with the laying of the secondary UK legislation in parliament. PBOs continue to be a key area for the ACNFP to provide advice in 2025 and beyond. 

Another world-leading area of novel foods is the FSA’s ongoing programme on the safety of cannabidiol (CBD) containing foods. The review of the technical data has been a significant and challenging area of work for the ACNFP, which merited the establishment of a specific joint ACNFP and Committee on Toxicity (COT) subgroup on CBD and hemp derived products. Preparatory and technical work began in 2022. A provisional acceptable daily intake (ADI) of 10 mg/day for pure >98% CBD as a novel food ingredient, was published as consumer advice by the FSA in October 2023. This work led to a world first in establishing such advice. The 2023 publication of the provisional ADI for pure CBD had provided a basis for the evaluation of applicants’ dossiers on CBD-containing products. In 2024, a Safe Upper Limit for THC as a contaminant in foods at or below 1 µg/kg bw/day was established, and a joint ACNFP/COT statement paper is due for publication in 2025. We look forward to the sub-group continuing with the work on hemp-derived ingredients and food matrices containing a range of cannabinoids and hemp extracts in the months ahead.

A new pioneering area of novel foods is the FSA’s new regulatory sandbox programme for cell cultivated products (CCPs). The ACNFP has begun work to scope the review of innovative alternative proteins and newly emerging Cell Cultivated Products (CCPs). In 2024, the ACNFP reviewed and accepted a proposal by FSA and FSS to establish a Subgroup that will lead reviews on cell cultivated products (CCPs) over the next 2 years. In early 2025, the ACNFP held an open session with FSA and external observers from industry to explore hazards associated with CCPs. This provided greater transparency into this new work for ACNFP. CCPs are an exciting area of innovation for the ACNFP to work on, both as new novel food and new processes, and we look forward to this challenging area of work.

In this financial year, the ACNFP reviewed safety dossiers for 27 applications for novel food products and 8 GM applications. ACNFP finalised 26 Committee Advice Documents (CADs) for publication for 19 novel foods and 7 GM applications for the UK covering a wide range of food innovations. This continues to support the FSA post EU-exit and ensure that UK consumers can access innovative products and be confident in their safety. 

The strength of the ACNFP continues to be the multi-disciplinary membership and the range of expertise being brought to the applications and issues under consideration. I sincerely thank the members and the FSA secretariat for their continued diligence, professionalism and flexibility in dealing with the ever-increasing volume of work during this financial year, of a high technical level, to high quality under time pressure. We look forward to a significant programme of work continuing in 2025-2026, supporting the FSA in its role of assessing the safety and integrity of UK food innovation.

Dr Camilla Alexander-White, Chair of the ACNFP.

April 2025

1. Introduction

The ACNFP has a long history of providing advice to the FSA in England, Wales and Northern Ireland and FSS on novel foods and processes. Under Regulation (EU) 2015/2283 as assimilated in UK law post EU Exit, a novel food is defined as a food that does not have a significant history of consumption within the United Kingdom before 15 May 1997. As a regulated product, the food is subject to an assessment process to ensure that it is safe, does not mislead the consumer and would not put consumers at a nutritional disadvantage. The Committee’s advice to the FSA (and FSS) contributes to the development of the Agency’s strategic objectives and ways of working to ensure that food is safe and what it says it is.

Over recent years the work of the FSA has evolved to reflect the legal context in which it operates. Prior to the 2018 revision of the EU Novel Food Regulation, the ACNFP looked at all novel foods submitted to the UK for evaluation and reviewed the opinions of other authorities in the EU, undertaking these assessments. The decision for the UK to leave the European Union brought subsequent changes to the Committee’s roles and responsibilities. Since 1 January 2021, at the end of the EU-exit transition period, the remit of the ACNFP was to provide national advice to the FSA on the scientific evaluation, once again, of all novel foods and genetically modified (GM) products of genetic technologies used as food and feed. The FSA, FSS and the Secretary of State in England and equivalent ministers in the nations of the UK became responsible for implementing national regulation in full relating to novel foods and processes.

This longer annual report covers 15 months and reflects the period between January 2024 and March 2025. The move from a calendar year to a financial year report, supports consistency across the work of the FSA’s Scientific Advisory Committees (SAC’s) and puts reporting in line with the financial reporting mechanisms for the FSA.

This change falls at a time of considerable outputs for the Committee, as the work of the ACNFP has continued to increase. This has included establishing a new Subgroup to focus on the innovative review of Cell Cultivated Products as new potential foods for the GB market.

The ACNFP continues to be bound by the principles in its code of practice. At the heart of its approach to assessing the applications received is:

• Openness and transparency – While the information reviewed by the Committee has commercial sensitivity, the Committee, with the support of the Secretariat, endeavours to be open about the work and the nature of the assessment being undertaken to ensure consumers can have confidence in the independence of the view generated and applicants have the tools to do the right thing.
• Proportionality – Seeking to strike a balance where each application is subject to a thorough assessment proportionate to the food safety risks it might pose. Achieving this is a continuous improvement process embedded into the ways of working of the Committee. While all uncertainty and risk cannot be removed for food and feed seeking authorisation, the Committee seek to be clear on the characterisation of risk and uncertainty to inform the decisions of Risk Managers in the risk analysis process.
• Supporting businesses to do the right thing – providing clear advice and guidance to the applicants so that they can provide the information needed for assessment and ensure the safety of their products.
• Innovation- Seeking to evolve the Committee’s ways of working and practices to ensure the core objectives are achieved using the best available science and up to date thinking in the members areas of expertise and on the approach to assessment.

In this context in 2024 and up to the end of the financial year in March 2025, the primary role of the ACNFP has been to provide scientific advice to FSA and FSS on novel foods and Genetically Modified Organisms (GMO) applications considered under the market authorisations for regulated products process and for which scientific and technical advice is requested.

Novel food applications - The ACNFP carried out the review process for nineteen novel foods dossiers. Five of these were returning dossiers some of which had commenced assessments in 2021, progressing to the first drafts as Committee Advice Documents (CAD) in 2022 or 2023 and the first publications of these in 2024 or 2025. The assessments continue to be based on the requirements in the regulation (EU) 2015/2283 as assimilated into UK law. Full details for the UK processes for applicants can be found on the ACNFP Food Assessment pages.

Dr Mark Berry “This is the sixth year that I have worked with the ACNFP. As in previous years, it has been both a pleasure and a privilege to work with a group of people that is so richly diversified in terms of the broad range of skills, knowledge and experience that it collectively possesses. Moreover, the passion and commitment that the team shows does re-assure me that the chance of an unsafe food getting through the system un-noticed is very unlikely. Two of the largest work areas for us this year were “Precision breeding” (of crop plants) and foods containing cannabidiol (CBD). Both of these topics are addressed by sub-committees comprising members who have the most relevant knowledge to risk-assess them. Their initial findings then get passed to the broader ACNFP for us to ask further questions – according to our expertise. In my case, as a food innovator and inventor, I usually want to know what types of food and drink the applicant intends to add the new ingredient to and whether the product type or the overall formulation of ingredients in the product might pose a risk to consumers or to a sub-set of consumers such as: young children, teenagers, or the elderly. In recent years, our civil service colleagues have reminded us of our need to be “proportionate” in the analyses and tests that we ask applicants to carry out on their novel foods. I think this is a really important principle for us to follow.  It enables us to deliver our primary function of ensuring food safety without becoming a barrier to technical innovations in the UK food industry.”

Assessments by the Committee are tailored to the nature of the products and the risks posed by their proposed uses when consumed. The role of the Committee is to review the assessment developed by the applicant to ensure any key food safety risks with the product or its production are identified. This supports any risks being managed and informs risk management decisions by Ministers in the nations of the GB on authorisation or the conditions of their use.

In the initial review, Members advise the FSA on what further information is required to fully assess any risks and address any data gaps identified. The assessment of these products will continue in the new financial year, as further information is provided by applicants. Whilst the Committee’s remit is firmly in providing advice on technical risk assessments, the risk context is also considered. Members consider how the novel food is anticipated to be consumed and, as such, advisory comments to FSA risk managers can be made as part of the technical advice for FSA.

Traditional Foods from Third Countries - The Committee completed one review of a notification for a traditional food from third countries. This is a separate assessment process under the novel food regulation allowing for  review of the information provided by applicants based on experience of its extensive use in a third country. This informs whether there are reasoned safety objections to the Traditional Foods sale and whether a further review is needed to inform decisions by risk managers.

Cannabidiol - A major area of work on novel foods was the review of submissions for cannabidiol (CBD) containing ingredients. This has been the continued work of the Joint Subgroup of the ACNFP and Committee on Toxicity (COT) on CBD and hemp derived products. The workstream aims to efficiently review and assess the significant volume of available toxicology data for these novel foods. This is a clearly defined area of FSA policy.

In the reporting period, the ACNFP along with the Committee on Toxicity (COT) agreed a joint statement on establishing a Safe Upper Limit (SUL) for delta-9-tetrahydrocannabinol (Δ⁹-THC) and its precursor as contaminants of hemp-derived products including CBD novel foods. This concluded that oral exposure to THC (as the sum of Δ⁹-THC and Δ⁹-THCA) at or below 1 µg/kg bw/day is unlikely to be harmful under appropriate conditions of use. This has provided information on the evidence that has underpinned the assessment of THC as a contaminant in CBD novel foods.

Working through the many CBD product applications formed a significant part of the work of the Committee in the reporting period as the non-toxicological aspects of the dossiers are reviewed. The Subgroup moved to the next group of applications for broad spectrum CBD hemp derived products (group C) and identification of a proportionate assessment approach for CBD ingredients with a range of cannabinoids present. This is a technically challenging area of work given many of these ingredients do not appear to have been fully characterised by standard analytical methods and has formed a major part of discussions in the Subgroup.

Precision Bred Organisms (PBOs) - In 2024, the ACNFP continued to support the development of the framework for Precision Bred Organisms (PBOs), through their collective peer reviewing of an early draft of the technical guidance for applicants drafted by FSA Science. This ensured robust technical content prior to multiple iterations of policy and legal review, to produce a high-quality FSA document, with drafting completed in time to support the laying of the draft secondary legislation for precision bred plants used for food and animal feed in 2025.

Further detail on the work of the Committee between January 2024 and March 2025 can be found below.

2. Novel Food Applications

In 2024 and until March 2025, the ACNFP carried out an assessment of sixteen novel food applications that were accepted under Article 10 of Regulation (EU) 2015/2283 as assimilated into UK law. The applications that were considered during ACNFP main meetings are detailed in Table 1, below. The dossiers for CBD and PGT were considered by reserved business to reflect the commercial sensitivities and are detailed in section 4.

Details of the issues that were raised by the Committee can be found in the minutes of the relevant meetings on the ACNFP website.

Table 1: Novel Food applications considered by the Committee between January 2024 and March 2025

Application	Reference Number	Meeting	Committee’s Response
Calcidiol (25-Hydroxycholecalciferol Monohydrate)	RP35	February 2024	This novel food was first reviewed by the Committee in June 2021. The Committee had reviewed the novel food in February and April of 2023 following discussion on the data provided to address data gaps. The assessment has been finalised and published.
Vitamin D2 mushroom powder	RP1550	February 2024 & April 2024	This novel food was introduced to the Committee in September 2023. The FSA/FSS on the Committee’s advice sought further information from the applicant to address data gaps in February 2024 and April 2024. The assessment has been finalised and published.
Corn protein	RP1238	February 2024 and June 2024	This novel food was introduced to the Committee in February 2023. The FSA/FSS on the Committee’s advice sought further information from the applicant in February, April and September of 2023 to address ongoing data gaps. In February 2024 and June 2024, the Committee sought further information from the applicant to address data gaps. The dossier has since been withdrawn by the applicant.
2'-Fucosyllactose	RP1476	April 2024	This novel food was introduced to the Committee in September 2023. The assessment was finalised and published.
3'-Sialyllactose sodium salt	RP1477	April 2024	This novel food was introduced to the Committee in September 2023. The assessment was finalised and published.
6'-Sialyllactose sodium salt	RP1478	April 2024	This novel food was introduced to the Committee in September 2023. The assessment was finalised and published.
Olive fruit extract standardized in hydroxytyrosol	RP1074	April 2024	This novel food was introduced to the Committee in April 2023 and reviewed further in September 2023 and November 2023. The FSA/FSS on the Committees advice sought further information from the applicant to address data gaps. The dossier has since been withdrawn by the applicant.
Akkermansia muciniphila	RP1468	June 2024	This novel food was introduced to the Committee in April 2023 and reviewed further in June 2023.   The FSA/FSS on the Committee’s advice sought further information from the applicant to address data gaps and final responses were reviewed by correspondence over the following months. The assessment was finalised and published.
Krill Protein Hydrolysate	RP1290	September 2024	This novel food was introduced to the Committee in February 2023. The FSA/FSS on the Committee’s advice sought further information from the applicant.   The assessment has been finalised and published.
Dried Miracle Berry (DMB®)	RP1351	September 2024	This novel food was introduced to the Committee in April 2023 The FSA/FSS on the Committee’s advice sought further information from the applicant to address data gaps and reviewed again in November 2023. Final review was held by correspondence and the assessment was finalised and published.
Esterified Propoxylated Glycerol	RP1363	September 2024	This novel food was reviewed for the first time. The FSA/FSS on the Committee’s advice sought further information from the applicant to address data gaps. The dossier continues to be under review.
Dry Cacaofruit Cascara	RP1484	September 2024	This novel food was reviewed for the first time. The FSA/FSS on the Committee’s advice sought further information from the applicant to address data gaps. The dossier has since been withdrawn by the applicant.
Rhizomucor pusillus biomass (Fermotein®)	RP1215	February 2025	This novel food was introduced to the Committee in in February 2025. The FSA/FSS on the Committee’s advice sought further information from the applicant to address data gaps. The dossier continues to be under review.
Mung Bean Protein	RP32	November 2024	This novel food was introduced to the Committee in April 2021 and reviewed again in March 2022 and June 2022. The FSA/FSS on the Committee’s advice sought information to address data gaps during this time and further information had been sought from the applicant. A final review was held in November 2024 and the assessment is being finalised by correspondence.
Allulose	RP1130	November 2024	This novel food was reviewed for the first time. The FSA/FSS on the Committee’s advice sought further information from the applicant to address data gaps. The dossier continues to be under review.
Xanthobacter sp. SoF1 cells (Solein®)	RP1326	February 2025	This novel food was reviewed for the first time. The FSA/FSS on the Committee’s advice sought further information from the applicant to address data gaps. The dossier continues to be under review.

3. Traditional Food Applications

In 2024, one ‘traditional food from third countries’ notification was validated under Regulation (EU) 2015/2283 and passed on to the ACNFP Committee for review. This notification was for Baru nut (Dipteryx alata Vogel). The notification was assessed by the ACNFP, and their advice passed to FSA and FSS risk managers to inform the UK position on this dossier. The notification is detailed in Table 2.

Minutes and details of the issues that were raised by the Committee can be found in the relevant meetings on the ACNFP website.

Table 2: Traditional Food notifications considered by the committee during 2024 and until March 2025.

Application	Reference Number	Meeting	Committee’s Response	FSA/FSS Outcome
Baru nut (Dipteryx alata Vogel)	RP2176	June 2024	The Committee identified data gaps and found the proposed uses were not consistent with how it was used traditionally. These would need to be addressed before a conclusion could be made. Committee advice was passed on to risk managers.	Advice provided to policy colleagues – currently not authorised in the GB as the application did not progress.

4. The ACNFP subcommittees' work

a) Products of Genetic Techologies (PGT) Subcommittee

The Subcommittee had six virtual and one face to face meeting between January 2024 and March 2025. Six meetings were chaired by Dr Andy Greenfield, one meeting was chaired by Prof Wendy Harwood.

The majority of the work of the Subcommittee in 2024 has been on the safety assessment of Genetically Modified Organisms (GMO). This included the review of ten applications for new GMO authorisation (Table 3), including one for a GM microorganism. Traits introduced by GM ranged from “classic” herbicide/pesticide tolerances to improved nutritional profile, which had not been assessed by ACNFP previously. Eight applications required additional information before the Subcommittee could conclude on safety. Three applications needed further expertise not available in the Subcommittee to complete the assessment. Drafts of Committee Advice Documents (CADs) for the authorisation of six of these applications were agreed by the Subcommittee prior to escalation to the full ACNFP Committee for review. 

Assessments by Defra (Department for Environment, Food and Rural Affairs) and its Scientific Advisory Committee ACRE (Advisory Committee on Releases to the Environment) of the environmental release section of applications for GMO authorisation also contribute to the final safety opinion in documents produced by FSA; links with Defra and ACRE are maintained through regular updates from ACRE/Defra in PGT meetings and some shared Membership across both committees.

Table 3. Genetically Modified Organisms (GMO) applications considered by the Subcommittee between January 2024 and March 2025. (Reserved Business) 

Application	Reference Number	Meeting	Subcommittee’s Response
Genetically modified maize 3272 for food and feed use (New Authorisation)	RP1274	January 2024, March 2025	This application for new authorisation was considered for the first time in January 2024. A draft CAD was reviewed. Additional information was requested by the FSA/FSS on the advice of the Subcommittee to address data gaps. The assessment is ongoing.
Genetically modified soy leghemoglobin MXY0541 for food uses (New Authorisation)	RP735	January 2024, March 2025	This application for new authorisation was considered for the first time in January 2024. Additional information was requested by FSA/FSS on the advice of the Subcommittee to address data gaps. Further expert advice was requested (microbiologist with yeast specialism, toxicologist due to conflict); additional bioinformatics expertise was provided by a scientist from FERA Sciences. The assessment is ongoing
Genetically modified maize MON95379 for food and feed uses (New Authorisation)	RP1868	March 2024	This application for new authorisation was considered for the first time in March 2024. Additional information was requested by FSA/FSS on the advice of the Subcommittee to address data gaps.  The Subcommittee completed the assessment and the ACNFP agreed the output. The assessment is being finalised for publication.
Genetically modified maize MON87429 for food and feed uses (New Authorisation)	RP1962	May 2024	This application for new authorisation was considered for the first time in May 2024. No data gaps were identified. The Subcommittee completed the assessment and the ACNFP agreed the output. The assessment is being finalised for publication.
Genetically modified oilseed rape MS11 and MS11 x RF3 for food and feed uses (New Authorisation)	RP307	May 2024, July 2024	This application for new authorisation was considered for the second time in May 2024. Additional information was requested by FSA/FSS based on the advice of the Subcommittee to address data gaps. The Subcommittee completed the assessment and the ACNFP agreed the output. The assessment is being finalised for publication.
Genetically modified oilseed rape NS-B5ØØ27-4 for food and feed uses (New Authorisation)	RP1745	May 2024, July 2024, December 2024	This application for new authorisation was considered for the first time in May 2024. Further expert advice was requested; this was provided by an expert in fish veterinary sciences from the RoS. Additional information was requested by FSA/FSS on the advice of the Subcommittee to address data gaps. The assessment is ongoing.
Genetically modified oilseed rape LBFLFK (EPA + DHA) for food and feed uses (New Authorisation)	RP2065	July 2024, October 2024, December 2024	This application for new authorisation was considered for the first time in July 2024. Further expert advice was requested; this was provided by an expert in fish veterinary sciences from the RoS. Additional information was requested by FSA/FSS on the advice of the Subcommittee to address data gaps. The Subcommittee completed the assessment and the ACNFP agreed the output. The assessment is being finalised for publication.
Genetically modified maize Bt11 x MIR162 x MIR604 x MON 89034 x 5307 x GA21 for food and feed uses (New authorisation)	RP2044	October 2024, December 2024	This application for new authorisation was considered for the first time in October 2024. Additional information was requested by FSA/FSS on the advice of the Subcommittee to address data gaps. The Subcommittee completed the assessment and the ACNFP agreed the output. The assessment is being finalised for publication.
Genetically modified oilseed rape MS11 x RF3 x MON 88302 for food and feed uses (New authorisation)	RP2029	December 2024	This application for new authorisation was considered for the first time in December 2024. No data gaps were identified. The Subcommittee completed the assessment and the ACNFP agreed the output. The assessment is being finalised for publication.
Genetically modified B. Juncea RF3 for food and feed uses (New authorisation)	RP2178	March 2025	This application for new authorisation was considered for the first time in March 2025. Additional information was requested by FSA/FSS on the advice of the Subcommittee to address data gaps. The assessment is ongoing.

CAD: Committee Advice Document; RoS: Register of Specialists.

The Subcommittee has worked with the Secretariat to improve the GM assessment process from suitability check to publication of CADs. This was done through several in-meeting discussions on:

• the assessment of GM applications;
• the statistical methods for comparative analysis in GMO assessment, including review of the available expertise in PGT and in FSA;
• the scientific expertise needed for the assessment of GMOs with altered nutrition;
• the minimal data requirements to conclude on the safety assessment of GMOs;
• the challenges resulting from the expression levels of the newly introduced proteins in the safety assessment of some GMOs.

Discussions with the Secretariat have allowed the risk assessment team to implement changes to the process which ensures that relevant information and expertise required for the assessment are available to the subcommittee as necessary. As a result, additional expertise has been recruited to the Register of Specialists (RoS), which can be commissioned on an ad hoc basis, depending on needs.

Feedback from Members has also identified ways of working which minimise the time needed for the in-meeting review of returning applications (including final review by ACNFP) by focussing the attention where needed.

As part of new FSA processes to ensure efficiency in the safety assessment and authorisation of applications, FSA scientists have been reviewing publicly available risk assessments from other regulators to develop safety opinions and recommendations. In this context, the Subcommittee has provided advice on the suitability of applications for an FSA internal safety assessment based on other regulator opinion (ORO) to ensure the safety of GMOs (see Table 4).

Table 4. Genetically Modified Organisms (GMO) applications considered scientifically suitable for the FSA internal risk assessment process by the Subcommittee between January 2024 and March 2025. (Reserved Business)

Application	Reference Number	Meeting	Subcommittee’s Response
Genetically modified soybean MON 87705 x MON 87708 x MON 89788 for food and feed uses (New authorisation)	RP2149	December 2024	This application for new authorisation has received a positive opinion from another Regulator (EFSA). No data gaps were identified. The Subcommittee confirmed there were no additional considerations beyond those reviewed by EFSA. This information was used to support internal review by the FSA/FSS. The assessment was finalised. In March 2025 it was published and moved to risk management.

ORO: Other Regulator Opinion

Members, individually and as part of the Subcommittee, have also continued to support the work of FSA on the Precision Breeding framework, under great time pressure, in preparation of the secondary legislation associated with the Genetic Technology (Precision Breeding) Act 2023:

• Subcommittee Members were invited to opt in to support the drafting by Science FSA of the technical guidance for applications for the authorisation of precision bred organisms (PBOs) for food and feed marketing, to be developed between November 2023 and July 2024.
• The Subcommittee held one workshop to support Science FSA with expert advice on the draft technical guidance in May 2024. This also provided a first testing of the suitability of the draft guidance through performing the Tier 1 safety assessment and determining whether further assessment was required in Tier 2 for a range of potential PB crops.

The FSA draft document produced with the support of this expert scientific review was further amended following FSA policy and legal review, and the resulting FSA draft PB Technical Guidance for Applicants was published on 27^th February 2025, two days after the draft Genetic Technology (Precision Breeding) Regulations 2025 were laid before Parliament.

b) Joint ACNFP and COT Subgroup on CBD, cannabinoids and hemp derived products

The subgroup held 5 virtual meetings and one intersessional meeting via correspondence in 2024 performing and finalising the review of all available safety data for >98% pure CBD and moving forward the review of new data as relevant to a wider range of cannabinoids present in some ingredients, referred to as groups B and C (Table 5).

Outputs and statements from the subgroup were subject to review and agreement by both the COT and ACNFP before publication. The conclusions of the Subgroup in relation to establishing a Safe Upper Limit for delta-9-tetrahydrocannabinol (Δ⁹-THC) and its precursor as contaminants of hemp-derived products including CBD novel foods was presented in a meeting with ACNFP (September 2024) and finalised in the meeting in February 2025.

The advice from the subgroup and ACNFP enabled the FSA to derive an SUL concluding that oral exposure to THC (as the sum of Δ⁹-THC and Δ⁹-THCA) at or below 1 µg/kg bw/day is unlikely to be harmful under appropriate conditions of use. Following this, a joint ACNFP/COT statement paper was finalised and will be published on the ACNFP Website in 2025.

The derivation of an ADI for pure form CBD in 2023 continued to support the individual review by the ACNFP of CBD-containing novel foods applications as submitted in the regulated novel foods process. Each novel food application has been reviewed based on the data submitted before this is placed in the wider context of the data the FSA/FSS holds including the provisional ADI.

Based on the data held by the FSA / FSS consensus can be reached on the safety of 98% or greater purity CBD. However, there remain significant data gaps for other cannabinoids in hemp derived extracts, challenges in the consistent analysis of cannabinoids in food matrices, and the possibility for contamination of foodstuffs by THC. These areas were reviewed by the Subgroup in 2024 and will continue with ACNFP into 2025, as applications on CBD and hemp derived novel food ingredients move through the assessment process.  

The table below details the key issues considered at each meeting. 

Table 5. Papers considered by the Subgroup during 2024. (Reserved Business)

Meeting	Topic	Reference
February	Presentation on the current limitations in analytical methodology in quantifying cannabinoids. A continuation of the review of toxicological data submitted for CBD novel foods with a range of cannabinoids present (Group B). Review of information to support the development of a statement on the safe upper limit of THC as a contaminant in hemp derived products.	CBD09/24
May	Review of updated toxicological data submitted for ≥98% pure form CBD ingredients.   A discussion on characterisation of the whole dataset held by the FSA and the opportunities for data mapping to support the review of CBD novel food ingredients in Group B.	CBD10/24
July	Conclusions of review of toxicological data submitted for 98% or greater that were received after the earlier dataset was reviewed. A review of the provisional ADI in light of newly available data from applications and literature. Further development of the position paper statement on the updated guidance for safe upper limit of THC as a contaminant.	CBD11/24
September	Introduction to the toxicological information submitted on hemp extracts with less than 70% CBD (group C). Further development of the draft statement on the safe upper limit of THC as a contaminant.	CBD12/24
November	Drafting and finalising the position paper statement on the safe upper limit of THC as a contaminant. Creation and discussion of the approach to creation of an FSA Evidence Base on CBD. Review of published works available in the public domain and whether these contribute to altering the consumer advice set by the provisional ADI.	CBD13/24
November (Intersessional via correspondence)	The members finalised the statement on the updated guidance for safe upper limit of THC as a contaminant. Comments received on guidance to support the effective characterisation of CBD novel foods using current analytical methods	CBD13/24
January 2025	Further review of the toxicological information submitted on hemp extracts with less than 70% CBD to support the review of these applications. Finalization of the structure of the FSA evidence base on CBD and inclusion of the information held to date. Further review of additional published data on CBD and its relevance to the review of novel food applications.

5. Assessment of Cell Cultivated Products: establishing a new ACNFP Subgroup

In response to the successfully funded FSA cell cultivated products (CCP) regulatory 2-year Sandbox programme, as part of the Department for Science, Innovation and Technology Engineering Biology Sandbox Fund, as proposed by FSA and FSS, and agreed by the ACNFP in September 2024, a new dedicated ACNFP CCP Subgroup has been established. This new Subgroup will provide independent expertise on technical issues relating to CCPs. This work will also support the development of FSA technical guidance that will be used to inform the risk assessment of these new novel foods.

The terms of reference for the newly established Subgroup were discussed in the September 2024 and November 2024 meetings and the ACNFP will review these again as they are further developed in 2025. The Committee agreed on the initial 2-year scope of the Subgroup work. This is to focus on Cell Cultivated Products (CCP) of animal origin to align with FSA objectives.

In February 2025, the Committee held an open session on the hazards and uncertainties for Cell Cultivated Products that included external observers from industry. The outcome of the session has informed FSA and ACNFP Subgroup work going forward and the safety assessment needs for these novel foods and key topic areas identified will be explored further in the new financial year.

6. Other Issues

a) Ways of Working

In 2024 and until March 2025, the ACNFP was consulted on several topics relating to the scientific work of the FSA and how this is managed. Additionally, the ACNFP were consulted on a proposal for a new ACNFP Subgroup to assist the FSA with its work on cell cultivated products derived from mammalian cells (Table 6). Topics included: FSA’s approach to the evaluation of Cannabidiol (CBD), documents to further develop the regulated products services and processes, management of novel Cell Cultivated Product (CCP) and Alternative Protein type applications, as well as governance processes such as the annual report.

Minutes and details of the issues that were raised by the Committee can be found in the minutes of the relevant meetings on the ACNFP website.

Table 6: Other Issues.

Topic	Meeting	Committee’s Response
Regulated Product Service and continuous improvements (reserved business)	February 2024	The Committee was updated on planned improvements to the FSA regulated products service and ways of working. Members provided comments to inform refinement of the processes going forward.
Approach to CBD applications where a conclusion on safety cannot be reached (reserved business)	February 2024 and September 2024	The Committee considered the approach to managing the CBD applications for 98% of greater purity CBD in light of the provisional ADI. The Committee also considered the proposed approach for CBD novel food applications where significant data gaps remain.
Annual report 2023	June 2024	The Committee reviewed the annual report draft and made changes to agree on the final report of the ACNFP’s work in 2023.
Establishing a new ACNFP Subgroup: Alternative and Cell Cultivated Proteins Applications	September 2024	The Committee were introduced to a proposal Terms of Reference for a new Subgroup which would consider Cell Cultivated Products and Alternative Proteins applications. Members provided amendments and comments. Plans for the initial pieces of work of the Subgroup were also discussed.
Cell Cultivated Products Subgroup Proposal	November 2024	The Committee agreed that the Subgroup’s scope will initially focus on Cell Cultivated Products (CCP) of animal origin, until its next review. This agreement was to align with the FSA’s CCP regulatory Sandbox. The Committee reviewed and updated the proposed Terms of Reference. It was agreed that an open session on hazards associated with CCPs would be scheduled for February 2025.
Open session on Cell Cultivated Products (CCPs)	February 2025	The Committee held an open session on the hazards and uncertainties for Cell Cultivated Products. The safety assessment needs for these novel foods were discussed and key questions developed in the meeting for the FSA CCP Sandbox team to develop further and review again with the Committee.

The members of the Committee were also involved in a workshop arranged by the Secretariat to explore the latest developments on the assessment of allergenicity as detailed in Table 7. The workshop held in February 2024, brought together experts on food allergy from the Committee with wider experts specialising in food allergy and allergenicity. The outputs of this will inform the assessment of dossiers for new forms of protein and how to support applicants in providing tailored data relevant to the novel food seeking authorisation. The outcome of the workshop will be published on the ACNFP website shortly.

Table 7: Summary of workshops supported by Committee members.

Topic	Meeting	Committee’s Response
Assessment of the allergenicity of new foods	Separate workshop in February 2024	The workshop catalogued the state of the art in assessing allergenicity of new foods. Several recommendations were made by participants to support the best use of available data to support the review of new foods.

b) Reserved Business Items

A total of 21 items were considered under reserved business between January 2024 and March 2025 (Table 8). The discussions for these items were primarily in relation to new ways of working, handling sensitive issues such as precision breeding assessment guidance or dossiers on CBD where there are commercial sensitivities. While considered as reserved business during the assessment phase, final outputs will be placed in the public domain in due course.

Table 8: Items considered under reserved business.

Item/ Application	Reference Number	Meeting	Committee’s Response
Genetically modified maize and its sub-combinations NX603xT25xDAS-40278-9	RP1791	February 2024	The ACNFP reviewed and agreed the draft assessment output developed by the PGT. The assessment is being finalised for publication.
Genetically modified oilseed rape MON 94100	RP1869	February and April 2024	The ACNFP reviewed and agreed the draft assessment output developed by the PGT. The assessment is being finalised for publication. This application has since been withdrawn by the applicant.
Cannabidiol (CBD)	RP350	February 2024	The Committee reviewed this application. The assessment was finalised and has been published.
Cannabidiol (CBD)	RP07	February 2024	The Committee reviewed this application. The assessment was finalised and has been published.
Cannabidiol (CBD)	RP427	April 2024	The Committee reviewed this application. The assessment was finalised and has been published.
Cannabidiol (CBD)	RP793	April 2024 and September 2024	The Committee reviewed this application. The assessment was finalised and has been published.
Genetically modified Maize MON 95379	RP1868	April 2024	The ACNFP reviewed and agreed the draft assessment output developed by the PGT. The assessment is being finalised for publication.
Update on the work to support development of regime to regulate Precision Bred Organisms	N/A	April and May 2024	The Committee was updated on the work of the PGT Subcommittee to support the development of an assessment framework for Precision Bred Organisms. This provided a basis for the workshop held in May 2024.
Genetically modified Maize MON87429	RP1962	June 2024	The ACNFP reviewed and agreed the draft assessment output developed by the PGT Subcommittee. The assessment is being finalised for publication.
Cannabidiol (CBD)	RP11	June 2024	The Committee reviewed this application. The assessment was finalised and has been published.
Cannabidiol (CBD)	RP340	June 2024 & February 2025	The Committee reviewed this application. Additional review was requested by FSA/FSS on the advice of the ACNFP to address data gaps in June 2024 and February 2025. The assessment was finalised and has been published.
Genetically modified oilseed rape MS11 and MS11 x RF3	RP307	September 2024	The ACNFP reviewed and agreed the draft assessment output developed by the PGT Subcommittee. The assessment was finalised and has been published.
Cannabidiol (CBD)	RP349	September 2024	The Committee reviewed this application. The assessment was finalised and has been published.
Cannabidiol (CBD)	RP176	September 2024 & February 2025	The Committee reviewed this application. In February 2025, FSA/FSS on the advice of the ACNFP sought further information from the applicant. The assessment was finalised for publication pending minor amendment.
Draft statement on Tetrahydrocannabinol (THC) as a contaminant in food -	N/A	September 2024 & February 2025	The Committee first reviewed a draft statement on THC as a contaminant, under development by the joint ACNFP/ COT Subgroup, in September 2024. It was reviewed further and finalised in parallel to the COT in February 2025.
Cannabidiol (CBD)	RP354	November 2024	The Committee reviewed this application. FSA/FSS on the advice of the Committee sought further information from the applicant. The assessment was finalised and has been published.
Cannabidiol (CBD)	RP521	November 2024	The Committee reviewed this application. The FSA/FSS on the Committee’s advice sought further information from the applicant. The assessment was finalised and has been published.
Cannabidiol (CBD)	RP294	February 2025	The Committee reviewed this application. The FSA/FSS on the Committee’s advice sought further information from the applicant. The assessment was finalised for publication pending minor amendment
Genetically modified Oilseed Rape MS11 x RF3 x MON 88302	RP2029	February 2025	The ACNFP reviewed and agreed the draft assessment output developed by the PGT Subcommittee. The assessment is being finalised for publication.
Genetically modified Maize Bt11 x MIR162 x MIR604 x MON 89034 x 5307 x GA21	RP2044	February 2025	The ACNFP reviewed and agreed the draft assessment output developed by the PGT Subcommittee. The assessment is being finalised for publication.
Genetically modified oilseed rape LBFLFK (EPA + DHA)	RP2065	February 2025	The ACNFP reviewed and agreed the draft assessment output developed by the PGT. The assessment is being finalised for publication

 7. ANNEX 1 – Information about the Committee

ACNFP - remit, membership and Members' interests.

Remit

The Advisory Committee on Novel Foods and Processes is an independent body of experts. This means they are not employed by the Government. Their remit is:

" To advise the Food Standards Agency (England Wales and Northern Ireland) and Food Standards Scotland on any matters relating to novel foods, traditional novel foods, food and feed products of genetic technologies and novel food processes including food irradiation, having regard where appropriate to the views of relevant expert bodies ".

Officials of the Food Standards Agency provide the Secretariat. As well as formal meetings, the Committee periodically organises workshops on specific topics related to its remit.

Membership of the Committee during 2024 and until March 2025

The membership of the Committee provides a wide range of expertise in fields of relevance in the assessment of novel foods and processes and molecular biology.  A list of the membership between January 2024 and March 2025, together with the names of the FSA assessors, can be found below.

Chair

Dr Camilla Alexander-White BSc (Hons) DPhil CChem FRSC ERT (Toxicologist) 

(Term began: July 2020) 

Lead Policy Advisor in Chemical Policy, Royal Society of Chemistry

Director MKTox & Co Ltd – independent chemical safety assessor.

Also the Co-Chair of the CBD Subgroup.

Members

Dr Anton Alldrick BSc(Hons), PhD (Safety Management)

Currently a director of A & M Alldrick Ltd, providing consultancy services to the agri-food sector.

Mrs Alison Austin BSc. (Joint Hons) (Consumer Needs Representative)

Director at Environment and Business

Independent consultant Environmental, Social and Governance Strategy Development. Non-Executive Director of the Consumer Council for Water.

Also Member of the CBD Subgroup

Dr Meera Cush BSc (Hons), MSc, PhD, CBiol, ERT (Toxicologist)

(Term began: March 2024)

Senior Managing Consultant in Regulatory Toxicology at Ramboll UK Ltd

Also a Member of the Committee on Carcinogenicity of Chemicals in Food, Consumer Products and the Environment (COC), Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT)

Independent Expert of the REACH Independent Scientific Experts Pool for the Health and Safety Executive.

Dr Sophie Foley BSc (Hons), PhD (Microbiology Specialist)

(Term began: March 2024)

Associate Professor in Microbiology at Edinburgh Napier University

Associate Dean – International, School of Applied Sciences.

Dr Isabel Skypala BSc, PhD (Allergy Dietitian)

(Term began: March 2024)

Lead consultant dietitian, adult food allergy service, Royal Brompton & Harefield Hospital.

Dr Lynn McIntyre BSc (Hons), PhD (Food Microbiologist)

(Term began: March 2024)

Principal Lecturer at Harper Adams University.

Interim Director for Harper Food Innovation

External examiner and reviewer (Food Microbiology journals)

Dr Mark Berry BA, PhD (Innovator and inventor)

Independent Consultant Founder & Director at Food and Life Sciences Consulting Ltd.

Professor Dimitris Charalampopoulos BSc, MSc, PhD (Fermentation Specialist)

Professor of Food Biotechnology at the University of Reading. Co-Director of the BBSRC Biomass Biorefinery Network (BBNet) and Senior Editor of Food Chemistry journal Innovate UK

Dr Catharina Edwards BSc, PhD (Nutrition Scientist)
Group leader of Research at Quadram Institute Biosciences, within the Food, Microbiome and Health programme

Professor Paul Fraser PhD, (Molecular Biologist)

Head of Plant Molecular Sciences, Royal Holloway University of London.

Also Member of the PGT Subgroup

Professor Susan Fairweather-Tait BSc, MSc, PhD, DSc Hon FNS (Nutritionist)

Professor of Human Nutrition, Norwich Medical School, University of East Anglia.

Professor George Bassel PhD, (Plant Scientist)

Professor of Plant Science at The University of Warwick

Also Member of PGT Subcommittee

Dr Hamid Ghoddusi BSc, MSc, PhD (Food Scientist & Microbiologist)

(Term ended: June 2024)

Head of the Microbiology Research Unit at the London Metropolitan University.

Professor Wendy Harwood BSc, PhD, (Crop Genetics)

Emeritus Fellow at the John Innes Centre , Norwich.

Also Member of PGT Subcommittee

Professor Huw D Jones BSc, MSc, PhD, (Translational Genomics)

Chair in Translational Genomics for plant breeding, Aberystwyth University.

Also appointed Chair of the new CCP Subgroup. Member of PGT Subcommittee

Mrs Rebecca McKenzie BSc, MSc (Allergy Dietician)

(Term ended: June 2024)

Senior Specialist Dietician in Allergy, University College London Hospitals NHS Foundation Trust, London.

Professor Harry McArdle BSc, PhD (Nutritionist)

(Term ended: September 2024)
Emeritus Professor of Biomedical Sciences at the Rowett Institute of Nutrition and Health, University of Aberdeen. Honorary Professor of Biological Sciences, Nottingham University.

Dr Elizabeth Lund BSc, MSc, PGCE,PhD (Nutritionist and Ethicist)

Independent consultant in Research Ethics and Nutritional Study Design.

Vice-Chair of West London Gene Therapy Advisory Committee and Research Ethics Committee. Honorary Associate Professor, School of Biological Sciences, University of East Anglia.

Also Member of PGT Subcommittee

Professor Clare Mills BSc, PhD (Plant Science and Allergy Expert)

Professor of Molecular Allergology, at the Manchester Institute of Biotechnology, and Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences , University of Manchester and

School of Biosciences, University of Surrey, Guildford

Also Member of PGT Subcommittee

Rev. Professor Lesley Stanley MA (Oxon) PhD ERT FBTS (Toxicologist)

(Term ended: June 24. Co-opted to finish the CBD work)

An independent consultant in biomedical science and investigative toxicology

Also Member of the CBD Subgroup

Professor Hans Verhagen PhD (Toxicologist and Nutritionist)

Independent consultant in Food Safety and Nutrition, Board-Certified Toxicologist and Nutritionist. Visiting Professor at the University of Ulster and adjunct professor at the Technical University of Denmark.

Also Member of the PGT Subgroup

Dr Maureen Wakefield, FERA Science Ltd. BSc, PhD, (Entomologist)

Principal Scientist at Fera Science Ltd.

Fellow of the Royal Entomological Society

Chartered Biologist

Dr Ray Kemp BA, MSc, PhD (Consumer Representative)

Dr Kemp is an independent consultant and social scientist specialising in risk perception and communication. He is currently a member of various advisory committees including the UK Department of Health and Social Care’s Committee On the Medical Aspects of Radiation in the Environment (COMARE). Also Member of PGT Subcommittee

Dr Andy Greenfield, BA, PhD, MA (Genetics; Animals; Bioethics)

Member of the Regulatory Horizons Council (RHC), the Human Tissue Authority (HTA) and an honorary research fellow at the Nuffield Department of Women’s & Reproductive Health, University of Oxford.

Also Chair of PGT Subcommittee

Professor Bruce Whitelaw BSc, PhD (Genetics; Animals)

He holds the Chair of Animal Biotechnology at the University of Edinburgh and is the Director of The Roslin Institute. He currently focusses on genome editing technology and animal stem cells, aiming to advance novel applications for the agricultural and biomedical communities.

Also Member of PGT Subcommittee

Associate members

Dr Kimon-Andreas Karatzas BSc, PhD, (Microbiology Specialist)

(Term ended: June 2024)

Associate Professor of Food Microbiology at the University of Reading.

Dr Christine Bosch MSc, PhD, (Nutrition Scientist)

(Term ended: June 2024)

Associate Professor of Nutrition at the University of Leeds

Dr Antonio Peña-Fernández BSc, MSc, PhD, (Toxicologist)

(Term ended: June 2024)

Associate Professor of Toxicology at the University of Alcalá (Madrid, Spain). Associate Professor in Toxicology & Medical Sciences in the Leicester School of Allied Health Sciences at De Montfort University, Leicester, UK

Co-opted Members of the PGT Subcommittee

Professor Pete Lund MA, DPhil (ex officio member, ACRE representative, Molecular Microbiologist)

Professor Alastair Macrae BVM&S, CertSHP, PhD, DCHP DipECBHM, DipECSRHM FRCVS (Veterinary surgeon, Professor at University of Edinburgh)

FSA Assessor

Dr Paul Tossell – Team Leader, CBD and Radiological Policy Team

(Policy)

Observers from the Devolved Administrations

Ms Kaila Lee – Policy, FSA Wales

Ms Katy Williams – Policy, FSA Wales

Mr Xose Benitu Alvarez - Policy, FSA Wales

Mr Jeremy Mills - Policy, FSA Wales

Mr Peter Madden - Policy, FSA Wales

Mr Daniel Lynch - Policy, FSA NI

Ms Jemma Foster - Policy, FSA NI

Ms Siobhan Watt - Food Standards Scotland

Ms Krystle Boss - Food Standards Scotland

Ms Lucy Smythe - Food Standards Scotland

Dr Karen Pearson - Food Standards Scotland

Ms Aileen Livingstone - Food Standards Scotland

Mr Evangelos Katsoulis - Food Standards Scotland

FSA Secretariat

Mrs Ruth Willis - Technical Secretary

Mrs Priscilla Wanjiru - ACNFP Lead Secretariat

Mr Ben Haynes - CBD Lead Secretariat

Mrs Afielia Choudhry - Science Secretariat

Mr Matt Hall - Science Secretariat

Dr Daniel Lloyd - Science Secretariat

Dr Tahmina Khan – Science Secretariat

 Miss Jenny Rees - Science Secretariat

Mr Will Smith – Science Secretariat

Dr Rachael Oakenfull – Technical Secretary PGT

Dr Karin Heurlier - Senior Secretariat

Dr Rhys Williams - Senior Secretariat

Mr Liam Blacklock - Science Secretariat

Dr Andrew Hartley - Science Secretariat

Dr Annalisa Leone - Science Secretariat

Dr Lucy Thursfield - Science Secretariat

Ms Victoria Balch - Administrative Secretary

Ms Carol Scott - Administrative Secretariat

ACNFP Members' Interests during 2024 and until March 25

In common with other independent advisory committees the ACNFP is publishing a list of its members' commercial interests.  These are managed in line with Agency guidelines on handling of conflicts of interest revised in 2019. These have been divided into different categories relating to the type of interest:

Personal:                  a) direct employment or consultancy.

                                         b) occasional commissions.

                                         c) share holdings.

Non-personal:        a) fellowships.

                                         b) support which does not benefit the member directly e.g.  studentships.

Details of the interests held by members between January 2024 and March 2025 can be found on the ACNFP website.

Code of Conduct

A code of conduct for members of the Advisory Committee on Novel Foods and Processes (ACNFP)

Public service values

All members must:

• Follow the guidance on the Seven Principles of Public Life, these being selflessness, integrity, objectivity, accountability, openness, honesty and leadership.
• Observe the highest standards of impartiality, integrity and objectivity in relation to the advice they provide and the management of this Committee.
• Be accountable, through the Board of the Food Standards Agency and Health Ministers, to Parliament and the public for its activities and for the standard of advice it provides. The Board of the FSA and Health Ministers are answerable to Parliament for the policies and performance of this Committee, including the policy framework within which it operates.
• Comply with this Code, and ensure they understand their duties, rights and responsibilities, and that they are familiar with the function and role of this Committee and any relevant statements of Government policy. If necessary, members should consider undertaking relevant training to assist them in carrying out their role.
• Not misuse information gained in the course of their public service for personal gain or for political purpose, nor seek to use the opportunity of public service to promote their private interests or those of connected persons, firms, businesses or other organisations; and
• Not hold any paid or high-profile unpaid posts in a political party, and not engage in specific political activities on matters directly affecting the work of this Committee. When engaging in other political activities, Committee members should be conscious of their public role and exercise proper discretion. These restrictions do not apply to MPs (in those cases where MPs are eligible to be appointed), to councillors, or to Peers in relation to their conduct in the House of Lords.

The role of the ACNFP Chair

The Chair is responsible for:

• Providing effective leadership on the issues within the Committees terms of reference.
• Ensuring that the Committee meets at appropriate intervals and that the minutes of meetings and any reports to the Board of the Food Standards Agency accurately record the decisions taken and, where appropriate, the views of individual members.
• Representing the views of the Committee to the general public.
• Ensuring that new members are briefed and providing an assessment of their performance, on request, when members are considered for re-appointment to the Committee or for appointment to the board of some other public body.
• Ensure that every member of the Committee is heard and that no view is ignored or overlooked.
• Ensure unorthodox and contrary scientific views are given a fair hearing.
• Ensure that any significant diversity of opinion among the members of the Committee is accurately reflected in the report and in any other communications with the FSA.
• Advise on matters relating to FSA science as required by the FSA on an ad hoc basis or in emergencies.
• Engage with the wider networks of relevant experts including with the Chairs of SACs relevant to the FSA’s work.

Role of Committee Members

• Members are appointed as individuals to fulfil their role respective to the ACNFP.
• Members are not a representative of their profession, employer or interest group and have a duty to act in the public interest.
• If a member declares an organisation’s view rather than a personal view, they should make it clear at the time.

Members have collective responsibility for the operation of this Committee.

They must:

• Engage fully in collective consideration of the issues.
• In accordance with Government policy on openness, ensure that they adhere to the Code of Practice on Access to Government Information (including prompt responses to public requests for information); agree an Annual Report; and, where practicable and appropriate, provide suitable opportunities to open the work of the Committee to public scrutiny.
• Not divulge any information which is provided to the Committee in confidence.
• Ensure that an appropriate response is provided to complaints and other correspondence, if necessary, with reference to the sponsor department.
• Ensure that the Committee does not exceed its powers or functions.
• Members are free to question and comment on the information provided or the views expressed by any of the other members.
• Individual members should inform the Chair (or the Secretariat on his or her behalf) if they are invited to speak in public in their capacity as a committee member.
• A member’s role on the Committee should not be limited by the expertise or viewpoint she or he was asked to bring to it. Any statement/report belongs to the whole Committee. Members should regard themselves free to question and comment on the information provided or the views expressed by any of the other members, even though the views or information provided do not relate to their own area of expertise.
• If members believe the committee’s method of working is not rigorous or thorough enough, they have the right to ask that any remaining concerns they have be put on the record.
• Communications between the Committee and the Board of the Food Standards Agency will generally be through the Chair; except where the Committee has agreed that an individual member should act on its behalf. Nevertheless, any Member has the right of access to the Board of the Food Standards Agency on any matter that he or she believes raises important issues relating to his or her duties as a Committee Member. In such cases the agreement of the rest of the Committee should normally be sought.
• Individual Members can be removed from office by the Board of the Food Standards Agency, if they fail to perform the duties required of them in line with the standards expected in public office.

Communications with the FSA Board, Chief Scientific Adviser and Executive

• The Advisory Committee on Novel Foods and Processes works in collaboration with several other Committees where the topics under consideration would benefit from expert advice from other Committees. These include, but are not limited to:
• The FSA’s Science Council.
• The Committee on Toxicity of Food, Consumer Products and the Environment (COT).
• The Committee on Carcinogenicity of Food, Consumer Products and the Environment (COC).
• The Committee on Mutagenicity of Food, Consumer Products and the Environment (COM).
• Communications between the ACNFP and the Board of the Food Standards Agency will generally be through the Chair except where the ACNFP has agreed that an individual member should act on its behalf. Nevertheless, any Member has the right of access to the Board of the Food Standards Agency on any matter that he or she believes raises important issues relating to his or her duties as an ACNFP Member. In such cases the agreement of the rest of the ACNFP should normally be sought.
• Similarly, communications between the ACNFP and the FSA Executive will generally be through the ACNFP Secretariat although the ACNFP Chair has the right of access to the FSA Chief Scientific Adviser and Deputy CSA at all times.
• Any member also has the right of access to the FSA Chief Scientific Adviser on any matter which he or she believes raises important issues relating to his or her duties as a member. In such cases the agreement of the ACNFP Chair should normally be sought.

Declaration of interests and management of conflicts

• As an independent, open and transparent advisory body the ACNFP’s members must provide clear declarations of interests.   The full guidance on declaration of interests for SACs should be consulted by all members, however a summary is provided below.
• Not all interests are necessarily ones that will cause conflict with a member’s work with the ACNFP.  Interests that may be seen to have relevance to their role (either personal, non-personal or those of family/friends) or the specific topics under discussion at a ACNFP meeting should be declared so the Secretariat can make an assessment of whether it could be considered a potential conflict of interests and what action may be needed in response.
• Members of the Committee should inform the Secretariat in writing of their current personal and non-personal interests, when they are appointed, including the principal position(s) held. Only the name of the organisation and the nature of the interest are required; the amount of any salary etc. need not be disclosed.
• Members are asked to inform the Secretariat at any time of any change of their personal interests and will be invited to complete a declaration form once a year.
• The Secretariat maintains a register of interests for each member that is updated and published online regularly.  The register of interests should contain current or previous interests (including things like employment, consultancies, memberships, investments or other personal interests) that may, in general, be seen to directly affect the perceived independence of the member or benefit from information gained whilst acting as a ACNFP member (that is not already public).
• The register of interests should be kept up-to-date and be open to the public.
• At the start of the meeting the Chair should ask members to declare any interests potentially relevant to the items under discussion relating to themselves or their close family members.
• Based on this information, the Chair will consult with Secretariat, FSA staff and potentially other SAC members, and decide on an approach to managing the interest.
• In the case of interests declared by the Chair, the same process will apply as to when there is an absence of the chair; the relevant FSA staff are responsible for deciding whether an interest is a conflict and if so, how it should be managed. FSA staff may also request input from other ACNFP members on appropriate action. 
• The interests declared, and the chosen action should be recorded in the minutes of the meeting with the rationale for this decision.

Personal Liability of Committee Members

• A Committee member may be personally liable if he or she makes a fraudulent or negligent statement which results in a loss to a third party; or may commit a breach of confidence under common law or a criminal offence under insider dealing legislation, if he or she misuses information gained through their position
• However, the Government has indicated that individual members who have acted honestly, reasonably, in good faith and without negligence will not have to meet out of their own personal resources any personal civil liability which is incurred in execution or purported execution of their committee functions save where the person has acted recklessly. To this effect, a formal statement of indemnity has been drawn up.

Openness and publication of documents - general principles 

• The Committee operates to the standards of openness and transparency. It will work in accordance with guidelines by the FSA and relevant guidance and rules established across Government. These include:

1. The cross-Government Code of Practice for Scientific Advisory Committees (CoPSAC), which includes the:
2. Principles of Scientific Advice to Government
3. The FSA’s Good Practice Guidelines for SACs
4. The provisions under the Freedom of Information Act 2000 (the Act). 
5. Committee meeting agendas, papers, minutes and reports are published. While meetings are not open to the public as standard, open events are held regularly to provide public input into the work of the Committee
6. The Committee publishes an annual report.

Different types of interest

The following is intended as a guide to the kinds of interests that should be declared.  Where Members are uncertain as to whether an interest should be declared they should seek guidance from the Secretariat or, where it may concern a particular product which is to be considered at a meeting, from the Chair at that meeting.  If Members have interests not specified in these notes but which they believe could be regarded as influencing their advice, they should declare them.  However, neither the Members nor the Secretariat are under any obligation to search out links of which they might reasonably not be aware.  For example, either through not being aware of all the interests of family members, or of not being aware of links between one company and another.

Personal Interests

A personal interest involves the Member personally.  The main examples are:

• Consultancies and/or direct employment: any consultancy, directorship, position in or work for the industry or other relevant bodies which attracts regular or occasional payments in cash or kind.
• Fee-Paid Work: any commissioned work for which the member is paid in cash or kind.
• Shareholdings: any shareholding or other beneficial interest in shares of industry.  This does not include shareholdings through unit trusts or similar arrangements where the member has no influence on financial management.
• Membership or Affiliation to clubs or organizations with interests relevant to the work of the Committee.

Non-Personal Interests

A non-personal interest involves payment which benefits a department for which a member is responsible but is not received by the member personally.  The main examples are:

• Fellowships: the holding of a fellowship endowed by industry or other relevant body.
• Support by Industry or other relevant bodies: any payment, other support or sponsorship which does not convey any pecuniary or material benefit to a member personally, but which does benefit their position or department e.g.:
• a grant for the running of a unit or department for which a member is responsible.
• a grant or fellowship or other payment to sponsor a post or a member of staff or a post graduate research programme in the unit for which a member is responsible (this does not include financial assistance for undergraduate students).
• the commissioning of research or other work by, or advice from, staff who work in a unit for which a member is responsible.
• Members are under no obligation to seek out knowledge of work done for, or on behalf of, industry or other relevant bodies by departments for which they are responsible, if they would not normally expect to be informed.  Where members are responsible for organizations which receive funds from a very large number of companies involved in that industry, the Secretariat can agree with them a summary of non-personal interests rather than draw up a long list of companies.
• Trusteeships: any investment in industry held by a charity for which a member is a trustee.  Where a member is a trustee of a charity with investments in industry, the Secretariat can agree with the member a general declaration to cover this interest rather than draw up a detailed portfolio.

Definitions

For the purposes of the ACNFP ‘industry’ means:

• Companies, partnerships or individuals who are involved with the production, manufacture, packaging, sale, advertising, or supply of food or food processes, subject to the Food Safety Act 1990.
• Trade associations representing companies involved with such products.
• Companies, partnerships or individuals who are directly concerned with research, development or marketing of a food product which is being considered by the Committee.

'Other relevant bodies' refers to organisations with a specific interest in food issues, such as charitable organisations or lobby groups.

In this Code ‘the Secretariat’ means the Secretariat of the ACNFP.

FSA Good Practice Guidelines for The Independent Scientific Advisory Committees (Revised and updated July 2012)

Good practice guidelines for the independent Scientific Advisory Committees.

Introduction

The Government Chief Scientific Adviser’s Guidelines on the Use of Scientific and Engineering Advice in Policy Making set out the basic principles which government departments should follow in assembling and using scientific advice. The key elements are to:

• identify early the issues which need scientific and engineering advice and where public engagement is appropriate.
• draw on a wide range of expert advice sources, particularly where there is uncertainty.
• adopt an open and transparent approach to the scientific advisory process and publish the evidence and analysis as soon as possible.
• explain publicly the reasons for policy decisions, particularly when the decision appears to be inconsistent with scientific advice; and
• work collectively to ensure a joined-up approach throughout government to integrating scientific and engineering evidence and advice into policy making.

The Code of Practice for Scientific Advisory Committees and the Principles of Scientific Advice to Government provide more detailed guidance on the operation of scientific advisory committees (SACS) and their relationship with their sponsor Departments.

The Food Standards Agency’s Board adopted a Science Checklist in 2006 (updated in 2012) that makes explicit the points to be considered in the preparation of papers and proposals dealing with science-based issues, including those which draw on advice from the Scientific Advisory Committees (SACS).

These Good Practice Guidelines were drawn up in 2006 by the Chairs of the independent SACs that advise the FSA based on, and complementing, the Science Checklist. They were updated in 2012 in consultation with the General Advisory Committee on Science (GACS) (since replaced by the Science Council (SC)).

The Guidelines apply to the SACs that advise the FSA and for which the FSA is sole or lead sponsor Department:

Advisory Committee on Animal Feeding stuffs

Advisory Committee on Microbiological Safety of Foods

Advisory Committee on Novel Foods and Processes

Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment

Science Council

Advisory Committee for Social Science

For the SACs with a shared sponsorship the Guidelines apply formally to their advice to the

FSA: they may opt to follow them also in advising other sponsor Departments.

These committees share important characteristics. They:

• are independent.
• work in an open and transparent way; and
• are concerned with risk assessment and/or science governance, not with decisions about risk management.

The Guidelines relate primarily to the risk assessment process since this is the main purpose of most of the SACs.  However, the SACs may, where appropriate, comment on risks associated with different risk management options, highlight any wider issues raised by their assessment that they feel should be considered (distinguishing clearly between issues on which the SAC has an expert capability and remit, and any other issues), or any evidence gaps and/or needs for research or analysis. In addition, the SC and SSRC may advise the FSA on aspects of the governance of risk management, or on research that relates to risk management.

Twenty-nine principles of good practice have been developed. However, the different committees have different duties and discharge those duties in different ways. Therefore, not all the principles set out below will be applicable to all the committees, all of the time. The SACs have agreed to review their application of the principles annually and report this in their Annual Reports. Compliance with the Guidelines will also be covered in the annual self-assessments by Members and annual feedback meetings between each SAC Chair and the FSA Chief Scientist.

ACNFP self-assessment against the Good Practice Guidelines

Issue	Compliance?	Notes/Comments
Defining the problem and the approach
1. The FSA will ensure that issues it asks a SAC to address are clearly defined and take account of stakeholder expectations in discussion with the SAC Secretariat and where necessary the SAC Chair.  The SAC Chair will refer to the FSA if discussion suggests that further iteration and discussion of the task is necessary.  Where a SAC proposes to initiate a piece of work the SAC Chair and Secretariat will discuss this with FSA to ensure the definition and rationale for the work and its expected use by the FSA are clear.	Yes	ACNFP does this on a routine basis
Seeking input
2. The Secretariat will ensure that stakeholders are consulted at appropriate points in the SAC’s considerations.  It will consider with the FSA whether and how stakeholder views need to be taken into account in helping to identify the issue and frame the question for the committee.	Yes	A role of the ACNFP in January 2024 – March 2025 was to assess novel food and GM applications which due to commercial sensitivities the Committee cannot discuss the documents in public. However, we invite internal FSA and FSS stakeholders to view the meetings.   Applicants and external stakeholders can view minutes and papers that outline the nature of the discussions.   For traditional foods from third countries summaries of novel food notifications are produced by the Secretariat and cleared by the Committee which then go through a 10-day public consultation process.   A public discussion on the potential hazards from cell cultivated products was held in February 2025
3. Wherever possible, SAC discussions should be held in public	Yes	The Committee have indicated a wish to hold a public meeting, and opportunities for this are being explored as part of their wider work programme for 2025 / 26.
4. The scope of literature searches made on behalf of the SAC will be clearly set out.	Yes	Where this information is required and is not provided by the applicant the scope of the search is included in the relevant papers.
5. Steps will be taken to ensure that all available and relevant scientific evidence is rigorously considered by the Committee, including consulting external/additional scientific experts who may know of relevant unpublished or pre-publication data.	Yes	The Committee, with the assistance of the Secretariat also seeks further information and advice from other Committees or individual experts where required.
6. Data from stakeholders will be considered and weighted according to quality by the SAC.	Yes	Assessing the quality and relevance of data is a core function of the Committee’s work.
7. Consideration by the Secretariat and the Chair (and where appropriate the whole SAC) will be given to whether expertise in other disciplines will be needed.	Yes	Members are regularly asked whether further expertise is needed to support the discussion of particular topics.
8. Consideration will be given by the Secretariat or by the SAC, in discussion with the FSA, as to whether other SACs need to be consulted.	Yes	The Committee, with the assistance of the Secretariat also seeks further information and advice from other Committees or individual experts where required.
Validation
9. Study design, methods of measurement and the way that analysis of data has been carried out will be assessed by the SAC	Yes	For complex statistical questions the Secretariat can consult with specialists within the FSA. We consult experts in analytical methodology were this is needed, and the expertise does not reside in the Committee membership.
10. Data will be assessed by the Committee in accordance with the relevant principles of good practice, e.g., qualitative social science data will be assessed with reference to guidance from the Government’s Chief Social Researcher.	Yes – Where relevant
11. Formal statistical analyses will be included wherever appropriate. To support this, each SAC will have access to advice on quantitative analysis and modelling as needed	Yes	Evaluations of novel foods are mainly based on evidence provided by the applicant, including unpublished studies and commercially sensitive information. As such it is unlikely that there is sufficient data to apply quantitative methodologies. These are considered and applied where appropriate.
12. When considering what evidence needs to be collected for assessment, the following points will be considered: the potential for the need for different data for different parts of the UK or the relevance to the UK situation for any data originating outside the UK; and whether stakeholders can provide unpublished data.	Yes	Novel food and GM dossiers are prepared in line with EFSA guidance inherited at the time of the UK’s departure from the EU. This sets out clear data requirements and involves published and unpublished data. Consideration is given to whether there are specific areas for review of interest to different parts of the UK.
13. The list of references will make it clear which references have been subject to external peer review, and which have been peer reviewed through evaluation by the Committee, and if relevant, any that have not been peer reviewed.	Yes	The outputs of the review of dossiers includes references so that the sources of data used in the assessment are communicated. The text will comment on whether the data was a peer reviewed publication or unpublished data.
Uncertainty
14. When reporting outcomes, SACS will make explicit the level and type of uncertainty (both limitations on the quality of the available data and lack of knowledge) associated with their advice.	Yes	ACNFP complies with items 14 to 17 – outcomes are critically evaluated, and uncertainties are identified and communicated.
15. Any assumptions made by the SAC will be clearly spelled out, and, in reviews, previous assumptions will be challenged.	Yes
16. Data gaps will be identified and their impact on uncertainty assessed by the SAC.	Yes
17. An indication will be given by the SAC about whether the evidence base is changing or static, and if appropriate, how developments in the evidence base might affect key assumptions and conclusions.	Yes
Drawing conclusions
18. The SAC will be broad-minded, acknowledging where conflicting views exist and considering whether alternative interpretations fit the same evidence.	Yes	Where this arises, it is reflected in the minutes and the reporting of outcomes.
19. Where both risks and benefits have been considered, the committee will address each with the same rigour, as far as possible; it will make clear the degree of rigour and uncertainty, and any important constraints, in reporting its conclusions.	N/A	The Committee’s assessment focuses on safety and performs risk assessments which under the assimilated regulation 178/2002 EC does not allow for consideration of benefits.   Within the scope of the ACNFP’s work is providing technical advice on nutritional disadvantage. Assessment of this area is reported in line with lines 14-17 of this statement.
20. SAC decisions will include an explanation of where differences of opinion have arisen during discussions, specifically where there are unresolved issues, and why conclusions have been reached.  If it is not possible to reach a consensus, a minority report may be appended to the main report, setting out the differences in interpretation and conclusions, and the reasons for these, and the names of those supporting the minority report.	Yes	The final opinions are adopted by consensus, identifying the key issues and generally explaining the reasoning behind the Committee’s conclusions. Where there are a range of views these are outlined.
21. The SAC’s interpretation of results recommended actions or advice will be consistent with the quantitative and/or qualitative evidence and the degree of uncertainty associated with it.	Yes
22. SACs will make recommendations about general issues that may have relevance for other committees.	Yes
Communicating SAC’s conclusions
23. Conclusions will be expressed by the SAC in clear, simple terms and use the minimum caveats consistent with accuracy.	Yes	The Committee uses a plain English approach to its outputs. Regular review of the clarity of the outputs is made to ensure these are of an appropriate quality and suitable for the audience. Where needed lay summaries of statements are developed to support greater understanding of the outcomes by the public.
24. It will be made clear by the SAC where assessments have been based on the work of other bodies and where the SAC has started afresh, and there will be a clear statement of how the current conclusions compare with previous assessments.	Yes
25. The conclusions will be supported by a statement about their robustness and the extent to which judgement has had to be used.	Yes
26. As standard practice, the SAC secretariat will publish a full set of references (including the data used as the basis for risk assessment and other SAC opinions) at as early a stage as possible to support openness and transparency of decision-making.  Where this is not possible, reasons will be clearly set out, explained and a commitment made to future publication wherever possible.	Yes
27. The amount of material withheld by the SAC or FSA as being confidential will be kept to a minimum.  Where it is not possible to release material, the reasons will be clearly set out, explained and a commitment made to future publication wherever possible.	Yes	The committee assesses dossiers for GM and novel foods. The legislative framework in which these assessments are done states what information can remain confidential and is outside the Committee’s control.
28. Where proposals or papers being considered by the FSA Board rest on scientific evidence produced by a SAC, the Chair of the SAC (or a nominated expert member) will be invited to the table at the Open Board meetings at which the paper is discussed.  To maintain appropriate separation of risk assessment and risk management processes, the role of the Chairs will be limited to providing an independent view and assurance on how their committee’s advice has been reflected in the relevant policy proposals, and to answer Board Members’ questions on the science.  The Chairs may also, where appropriate, be invited to provide factual briefing to Board members about issues within their committees’ remits, in advance of discussion at open Board meetings.	N/A
29. The SAC will seek (and FSA will provide) timely feedback on actions taken (or not taken) in response to the SAC’s advice, and the rationale for these.	Yes	Regular policy updates on how Committee advice has been used is received at each meeting.

Financial Statement

ACNFP is an independent SAC but does not have resources of its own. The operation of the Committee is funded by the FSA. In the period of this report, costs for this support (covering Members expenses and fees and administrative cost for the meetings) were £155,826.