Food Hypersensitivity Programme Update

1. Summary

1.1 The Business Committee is invited to:

• note the work to date undertaken on Food Hypersensitivity;
• note the timeline for Provision of Information of going to FSA Board with a recommended approach during 2024; and
• comment on the shift in focus to development and delivery of the level-one training in the second half of the year.

2. Introduction

2.1 This paper provides an assurance and update to the Business Committee of   the progress and next steps against the plans for the Food Hypersensitivity work set out at September 2022 Board (FSA 22-09-07 - Food Hypersensitivity Programme: Outline plans for phase two), which were subsequently updated in the December 2022 re-prioritisation paper (FSA 22-12-05 - In Year Prioritisation).

2.2 At the September Board meeting we set out three key work areas for Food Hypersensitivity:

• Continuing work on Precautionary Allergen Labelling (PAL) to improve the way it is applied by industry, and its effectiveness as a consumer information tool.  This will include the use of thresholds for allergens which is an ongoing piece of work through Codex.
• Improving the Provision of Information for consumers in the non-prepacked food sector, with a priority focus on the accuracy of information. 
• Achieving a step-change in the knowledge, skills, and food safety culture in the non-prepacked sector through training for staff.

2.2 At the September Board meeting we set out three key work areas for Food Hypersensitivity:

• Continuing work on Precautionary Allergen Labelling (PAL) to improve the way it is applied by industry, and its effectiveness as a consumer information tool.  This will include the use of thresholds for allergens which is an ongoing piece of work through Codex.
• Improving the Provision of Information for consumers in the non-prepacked food sector, with a priority focus on the accuracy of information. 
• Achieving a step-change in the knowledge, skills, and food safety culture in the non-prepacked sector through training for staff.

2.3 However, at the December Board, it was agreed to revise the deliverables as part of the in-year prioritisation process to create capacity to deliver additional demands faced by the FSA.  It was agreed that:

• PAL would be our priority area and the work set out in September would be delivered, albeit over a slightly longer timescale.  
• Improving the Provision of Information work would focus on building the evidence base for future reform with any recommendations taking a further 12-24 months from December 2022. 
• Allergen training would focus on level-one only with initial work developing our understanding of target audiences, content, and delivery options.

2.4 As set out in the December paper the policy team have released staff (and not filled vacancies) to free up resources to support wider FSA priorities including food elements of cross-government priorities: Borders Targeting Operating Model, Retained EU Law (Reform and Revocation) Bill, and the Windsor Framework, as well as Precision Breeding and Regulated Products.  

2.5 The Retained EU Law (Reform and Revocation) Bill has been amended and now provides a set list of laws to remove by the end of the year.  However, the FSA will need to continue to support the Bill as it passes through Parliament, including working with the Government to identify longer-term reforms FSA will make ahead of the 2026 deadline.  The FSA has identified regulated products including novel foods as areas for potential high impact reforms using the time-limited powers of the Bill and therefore, we will continue to require legislative, strategic and policy capacity to work on these reforms.  The other work priorities described above also continue.  This means FSA’s current workload is not significantly reduced by the changes, and FSA will need to continue to carefully balance priorities and resources over the coming year. 

2.6 The reduced Food Hypersensitivity team have continued to deal with a high level of responsive work including correspondence, PQs, and supporting parliamentary debates and incidents.  Since December, we have used the majority of the remaining resources to continue work on PAL and complete the evidence gathering on improving the Provision of Information while we assessed the viability of approaches to the training as outlined below.  

2.7 Food Hypersensitivity remains a high-profile area of work and was a major part of a Westminster Hall Debate on Allergens on 15 May.  MPs who spoke at the debate expressed a consensus around the need for improvements to the way allergen information is provided when eating outside of the home.  During the debate, the Chair of the Health and Social Care Select Committee, Steve Brine, asked the Minister for Public Health, Neil O’Brien (who was responding on behalf of the Government) to “ensure that the strength of feeling in the House is made clear to the FSA.”  

2.8 Now in line with the previously agreed priorities set out above we will switch resources to focus on delivering the level-one training commitment set out in the Board papers with Provision of Information options due in 2024, and the pathway for PAL maintained.

3. Progress of Work Areas Against December 2022 Commitments

Precautionary Allergen Labelling (PAL) 

3.1 The objective for this workstream is to have a clearly understood and implementable system to apply PAL statements, linked to a standardised risk analysis process taking into account safe thresholds levels, to protect consumers.
 
3.2 The Codex Committee on Food Labelling (CCFL) has established an Ad Hoc Joint Food and Agriculture Organization (FAO)/ World Health Organization (WHO) Expert Consultation on Risk Assessment of Food Allergens to support the development of internationally agreed upon food safety standards and guidelines relevant to the management of food allergens.  The FSA will need to review and assess the findings and decide what the next steps are.  There will then need to be a strategic decision about the approach for the UK; and how to deliver consumer safety and choice while balancing pace and ease of implementation against the importance of international harmonisation.  This is likely to come to the Board in March 2024.

3.3 We are currently focussed on delivering short term improvements on PAL while supporting the assessment of these Codex standards and gathering additional evidence.  We have:

• Updated PAL standards for applying PAL to prepacked foods within the allergen labelling technical guidance for food business.  These proposed standards are: (a) that a risk assessment should precede PAL application, (b) that PAL statements should specify the allergen and (c) that PAL should not be used in combination with a ‘free from’ statement for the same allergen, recently went out to public consultation (which closed in May).  We are currently reviewing the consultation responses, but early indications are that respondees were supportive of the proposed changes.
• Commenced an assessment of the Joint FAO/WHO Expert Consultation report on Risk Assessment of Food Allergens (Part 2: Review and establish threshold levels in foods of the priority allergens) in conjunction with a Committee on Toxicity’s subgroup.  The assessment is carried out to understand whether there is sufficient evidence to demonstrate that using reference doses (RfDs) recommended by Codex would not significantly impact upon public health in the UK.  The report covers Codex’s eight priority allergens (peanuts, tree nuts, egg, milk, cereals containing gluten, sesame, fish and shrimps).  This work is due to be completed by October 2023.
• Reviewed analytical methodologies available in the UK to detect food allergens (report due to be published in June 2023). 
• Reviewed the guidance documents and scientific literature on allergen cleaning.  This will constitute part of the evidence base for potential future work to develop allergen cleaning guidance (report due to be published in June 2023).

Next steps

• We plan to publish the updated allergen labelling technical guidance for applying PAL to prepacked foods in September 2023.
• Depending on the outcome of the assessment of the Codex full report on threshold levels for the priority allergens we will:

1. Assess the FAO/WHO Joint Expert Committee report on threshold levels for regional allergens (lupin, soya, mustard and celery).  The report is expected in late 2023/early 2024.
2. Consider whether to replicate the approach for molluscs as the only one of the 14 regulated allergens not covered by Codex without a current threshold (sulphites have a threshold).

• Depending on the outcomes of this work we plan to bring strategic options for the suggested UK approach to PAL to the Board in early 2024.

3.4 Once the Board have agreed a strategic direction, we will need to take a stage-by-stage approach.  First, we will need to carry out further work to develop proposals.  This will require research looking at stakeholder perceptions of thresholds, the wording of PAL statements, and user testing on any proposals.  This work would take place spring/summer 2024 and would be subject to allocation of funds from the FY24/25 FSA budget.

3.5 Subject to the Board decision, and the outcomes of work outlined above, the second stage is that we would expect to carry out a PAL consultation on using a single statement linked to risk assessments carried out by Food Business Operators taking into account allergen thresholds in 2025.

Provision of Information when eating outside the home

3.6 The objective of this workstream is to improve the accuracy and communication of allergen information for non-prepacked food.

3.7 As agreed by the Board in September and prioritised in December, we have focused on carrying out the evidence-gathering work. This has consisted of: 

• An international review of different approaches for written information.
• A qualitative study of SMEs looking at how different ‘non-prepacked’ business models (such as restaurants) operate. 
• A consumer survey of the nature and extent of Food Hypersensitivity reactions, including where they occur and near-misses.
• An evaluation of the Prepacked for Direct Sale legislation consisting of qualitative surveys and interviews with consumers, food businesses, and local authorities.
• A study visit to the Republic of Ireland to learn more about how their national legislation works in practice and its effectiveness.
• Stakeholder engagement including the Food Hypersensitivity Expert Panel and Anaphylaxis UK Business Forum, and we held an evidence-gathering workshop with consumer groups in June.

Next steps

• Research to gather information on local authority views on current provision of information and understand any potential enforcement challenges of possible approaches.
• Evaluate all the evidence to support the development of options.
• Assess the options for benefits and risks and put them to the Board with a recommended approach during 2024. 

Developing allergen training for food businesses

3.8 As part of achieving a step-change in the knowledge, skills and food safety culture as set out in the September and December Board papers, we are focussing on improved understanding and better management of Food Hypersensitivity in the non-prepacked sector.  Our work is focused on developing a digital, web-based training platform to increase take-up amongst staff working in the sector.

3.9 We have spoken to stakeholders to gain a better understanding of the needs of target audiences, proposed content, and the different digital delivery options.  We have also considered the potential for delivering the training in collaboration with third parties.

3.10 Key conclusions following this stakeholder engagement are:

• While not standardised, most larger Food Business Operators provide training for staff.
• There is a significant gap for staff in smaller and micro sized businesses, which presents the best opportunity for a step change in provision.
• Current third-party training provision includes allergy consumer groups who offer paid-for training.  While there could be benefits to working with these stakeholders on content, a collaborative approach to delivery through this route could raise complications in respect to income generation (they generally charge for use). 

Next Steps

• Focus on developing the content for level-one training, which will provide essential allergen management information required by food business staff, using existing training providers. 
• Continue to explore routes for delivery including through an app-based microlearning platform and seeking suitable suppliers.

3.11 We are still assessing costs for this this work but have allocated funding for FY23/24, will seek agreement to delivery route and expect level-one training to launch in summer 2024.  

4. Conclusions

4.1    The Business Committee is invited to:

• note the work to date undertaken on Food Hypersensitivity;
• note the timeline for Provision of Information of going to the FSA Board with a recommended approach during 2024; and
• comment on the shift in focus to development and delivery of the level-one training in the second half of the year.