FSA 22-09-07 Food Hypersensitivity Programme: Outline plans for phase two

1. Summary

1.1    Following the June 2022 FSA Board update on Food Hypersensitivity (FHS), this paper sets out the priorities, key activities, and proposed timetable for phase two of the FHS programme (September 2022 to April 2024), taking into account feedback from the Board.

1.2    The Board is asked to:

• confirm the scope of the FSA's FHS work for phase two
• note the proposed timetable, particularly for the work on provision of information to consumers, including written information (this timetable will be further developed following scoping work this autumn).

2. Introduction

2.1    The aim of the FHS programme is to improve the quality of life for people with FHS. Fundamental to this is understanding the needs, views and preferences of consumers. We aim to achieve a culture change in how FHS is managed by food businesses to ensure that the needs of consumers are met and to reduce the risk of harm. We will continue to build our evidence base to inform our approach.

2.2    An update paper on FHS was discussed at the FSA Board meeting in June 2022 which set out the outcomes of phase one of the FHS programme and recommendations for phase two of our work.

2.3    The Board endorsed the priorities for phase two:

Priorities for phase two of the programme

Improving the provision of information for consumers, with a focus on the accuracy of information. The Board has asked for further work on options for improving written information, including legislative options.

Achieving a step-change in the knowledge, skills and food safety culture of staff in the ‘non-prepacked’ sector.

Continuing work on Precautionary Allergen Labelling to improve the way it is applied by industry, and its effectiveness as a consumer information tool.

The programme roadmap in Annex A outlines the planned work within these themes and estimated timescales (timescales are indicative and will be revised following further scoping work this autumn).

Work that will not be progressed at this stage 

An FSA-sponsored Food Allergy Safety Scheme. Although we do not recommend a stand-alone scheme, we will use the evidence from this work to develop the consumer information workstream and in our work to achieve a step-change in the ‘non-prepacked’ food sector.

A Food Allergic Reaction Reporting Mechanism. We will progress alternative routes to gather information about reactions and consumer experience.

3. Discussion

3.1    At the June 2022 Board meeting the Board asked us to assess the potential for timescales to be accelerated, including delivery of the training package, and to carry out further research looking at the viability of making written allergen information a legal requirement.

Outline plans for the activities under each priority theme are set out below. 

Priority theme 1: Improving the provision of information for consumers, with a priority focus on the accuracy of information.

Improving current practice: standardised ‘good practice’ resources

3.2    Our research found that both consumers and businesses support the standardisation of allergen information, along with the provision of tools and resources to support this. We plan to expand our standardisation of signage project to include the following resources:

• ‘Ask about allergens’ signage with guidance for businesses on formatting and placement, so it is clear and accessible
• guidance on conducting effective conversations between consumers and staff on the presence of allergens in food, and the risk of cross-contact
• guidance on the provision of written information on menus and in allergen matrix documents, including the consideration of digital ordering systems within food premises
• guidance on confirming to consumers that allergens have been correctly managed when food is presented.

These resources will provide businesses with information on how they can comply with legislation and enable them to access tools and resources tailored to different business models.

This work would provide an early opportunity to test how food businesses respond in practice to a call for improving and standardising information throughout the consumer journey. It is due to complete ahead of the training work (see paragraphs 3.5 – 3.7) and will inform our training package.

Improving current practice: work with online aggregators

We will continue our work with the Achieving Business Compliance (ABC) programme and online aggregator platforms on the Food Safety Charter Project to improve the provision of allergen information when food is purchased online.

Future reform options: provision of information in the non-prepacked sector

3.3    In response to the Board’s request for further work to be carried out on making written allergen information a legal requirement, we will: 

• review the effectiveness of different approaches for written information: we will investigate approaches for providing written information to assess their effectiveness.  This will include looking at models used in other countries. As part of this work, we will look in detail at the approach taken in Ireland and how the legal requirement for written information is now being implemented by businesses. 
• carry out research to better understand how different ‘non-prepacked’ business models operate so we can understand what can be safely implemented: building on our most recent social science research, we will speak to smaller businesses (for example, cafes, mobile sellers and takeaways) and trade bodies to gather information on how they provide allergen information. This will include qualitative ‘deep dive’ and ‘case study’ approaches to better understand business allergen management practices and the challenges and opportunities mandation of written information might present. 
• engage with local authorities: we will speak to local authorities to gather views on the effectiveness of current allergen information provision, and how it could be improved. This will include considering the potential for mandating written information and the enforcement opportunities and challenges this would present.
• improve our understanding of where FHS reactions occur in the non-prepacked sector: we currently have a data gap on FHS reactions which do not result in hospitalisation. We have longer-term plans to address this through establishing a regular consumer survey (see paragraph 3.15) To address this in the short-term, we plan to carry out a one-off survey (between December 2022 and March 2023) to gather information on the nature and extent of FHS reactions and near-misses.
• consider lessons from the introduction of the ‘prepacked for direct sale’ (PPDS) labelling legislation: Our formal evaluation of PPDS implementation will begin in October 2022 (with the final report due in April 2023). This work will gather feedback from consumers, food businesses and local authorities in England, Wales and Northern Ireland, and its outputs will inform our work on the provision of written information in the non-prepacked sector.

See the roadmap in Annex A for timescales.

Priority theme 2: Achieving a step-change in the knowledge, skills and food safety culture in the non-prepacked sector

Training for staff working in the non-prepacked sector

3.4    The delivery of FHS training for the non-prepacked sector is a priority for the FHS programme. The FSA has a statutory remit to offer training within the Food Standards Act (1999) and it is evident that there is a gap in current provision that the FSA is well placed to address.

3.5    The focus will be on creating behaviour change through an innovative, interactive approach which will ensure that staff in the non-prepacked sector (including those working in micro and small businesses) have access to effective training that covers the essentials of FHS information and management. 

3.6    In the June 2022 update we proposed that the FSA develops a ‘three level’ training package. ‘Level one’ would provide essential information relevant to all staff (including front of house staff), with ‘level two’ and ‘level three’ providing information for those staff with higher levels of responsibility and expertise.

3.7    The Board asked us to consider how the work could be delivered at pace and we have revised our outline timings to focus on developing level one as a digital training package where there is a significant gap in current provision. We have also considered how we can work with external providers on levels two and three - our preferred approach is likely to be to provide guidance and a framework for third parties to deliver these elements. Delivering an innovative and interactive level one training package will take up to 18 months, and is likely to cover: 

• building understanding and empathy amongst staff for people with FHS, including considering the impact of FHS on safety and quality of life
• understanding allergen management, including cross-contact
• the role of individuals in the food businesses and how to create a shared sense of responsibility across all levels of the business
• how to engage with people with FHS, including conveying information to consumers and throughout the business
• what to do in the event of a problem or emergency.  

See the roadmap in Annex A for timescales. 

Whilst the training package is in development we will promote existing training resources, including the FSA’s allergen and intolerance e-learning module. The standardisation work (see paragraph 3.2) will conclude ahead of training work and provide resources which can be used in advance of the training package completion. 

Developing our guidance resources

3.8    Our Safer Food Better Business and Safe Catering resources are trusted by businesses, and we want to build on this success.

We will work with colleagues across the FSA to update these resources using the outputs of our work on FHS.

We will also update our Technical Guidance on ‘Food allergen labelling and information’ to include ‘good practice’ examples and revised PAL information. 

Role of local authorities in supporting compliance and enforcement

3.9    We will examine the current approaches available to local authorities in their advising and enforcing roles and undertake more detailed work on the potential for civil sanctions to provide an additional enforcement tool, recognising and exploring the potential risks highlighted in discussion at the June Board.

Priority Theme 3: Continuing work on Precautionary Allergen Labelling (PAL) to improve the way PAL is applied by industry and its effectiveness as a consumer information tool

3.10    Our PAL work to date has highlighted the need to keep consumers safe without unnecessarily limiting their food choices, whilst ensuring solutions are workable for food businesses. In the June 2022 FHS update board paper we said we will work with businesses to ensure PAL is:

Communicated more clearly and consistently, in an understandable and meaningful way.

Based on proportionate and standardised processes for assessing, managing, and communicating the risk of allergen cross-contamination by food businesses.

3.11    This work is organised around three work areas:

1. Working towards a standardised system for applying precautionary allergen labelling to prepacked food products
2. Supporting small and medium-sized enterprises (SMEs) to do the right thing 
3. Improving allergen cross-contact risk management and communication in the non-prepacked sector 

3.12    In response to the request by the Board to consider where timescales can be accelerated, we have identified three work activities which could be carried out this financial year if funding was made available:

A literature review of allergen tests available for 14 regulated allergens 

This would consider the efficacy, practicability, and affordability of current testing to enable us to better understand viability of testing for allergens if allergen thresholds were to be agreed for some or all of the 14 regulated allergens.  

Update of technical guidance with PAL guiding standards 

In the recent “may contain” consultation there was support for the three proposed standards:

• that a risk assessment should precede PAL application
• that PAL statements should specify the allergen
• that PAL should not be used in combination with a ‘free from’ statement for the same allergen.

We plan to incorporate these as best-practice within the technical guidance.

An international review of allergen cleaning guidance

Previous and recent research has shown us that uncertainty around the effectiveness of cleaning to avoid allergen contamination is a barrier to effective use of PAL, and that PAL should only be used when there is an unavoidable risk of the unintended presence of an allergen that cannot be sufficiently controlled. 

Many SMEs face difficulties in assessing whether the risk of allergen cross-contact has been sufficiently controlled, because without routine testing, they do not know how effective control measures (cleaning in particular) are. 

This review would be the starting point of revised allergen cleaning guidance to support judicious use of PAL. The guidance will be co-developed with industry. It will help us to identify any evidence gaps, and potentially commission further research in order to have a robust evidence base to inform guidance.

3.13    In addition to the above we will also begin other longer-term pieces of work (planned for delivery by 2024/25):

Review of Codex thresholds full report

The UK as co-chair of the Codex Committee on Food Labelling Allergen Labelling e-working group has been supporting the work of the Expert Committee that includes three UK experts: Paul Turner, Claire Mills, and Rene Crevel. The Committee is carrying out three pieces of work:

• review and validation of Codex priority allergen list through risk assessment
• review and establish threshold levels in foods of the priority allergens
• review and establish [principles/international guidance for applying] precautionary allergen labelling in foods of the priority allergens

In autumn 2022, Codex will publish a report recommending threshold levels for the allergens they assess to be of global concern. SERD will review this report and the evaluation criteria applied by the Expert Committee. If they are content with the approach, they will replicate it for the 6 UK regulated allergens that were not subject to the Codex Expert Committee's Review, (celery, lupin, molluscs, mustard, soybeans, and sulphites). 

Preparing for a potential consultation on a workable system for applying PAL to prepacked foods (with thresholds as the lynchpin)

This consultation would take place once we have gathered and reviewed evidence on thresholds and allergen testing. It is likely to have four elements:

• whether to set thresholds (and at what levels) for each of the 14 allergens
• what the single standardised wording on prepacked food products should be to indicate a threshold level has been exceeded
• whether there should be a regular allergen testing requirement for food businesses over a certain size
• whether products should be marked to indicate that allergen testing has been conducted on a representative sample of products

Co-develop allergen cleaning guidance with industry 

In order to support food businesses that do not conduct routine allergen testing to apply PAL more effectively, we will provide guidance on cleaning, which is the key control to manage allergen cross-contact, other than segregation. The nature and scope of the guidance will be evidence-based, depending on the results of our further work in phase 2.

Developing our research and evidence base

3.14    We will continue to review existing research and commission new research to support the three priority themes, along with our wider work on FHS, to ensure our policy recommendations are evidence-based. Three FSA funded pieces of research are due for publication in Autumn:

• Wave 2 of the ‘Food Sensitive’ study which examines how people with FHS manage their hypersensitivity, as well as the resulting impact on their quality of life.
• a report looking at the impacts of FHS on quality of life and the monetary value people assign to the removal of those impacts.
• a report quantifying the financial impact of managing FHS on households. 

3.15    We plan to carry out a regular survey of consumers to gather information on the nature and extent of FHS reactions and near misses and intend to conduct a baseline survey in 2023, with a subsequent biennial survey. (An early version of this survey will be conducted to inform our provision of information work – see paragraph 3.3)

Communications and engagement activity to support FHS workstreams

3.16    We will carry out communications activity to support the activities outlined in the paper. For example, targeted communications activity to support the roll out of the training package to ensure high levels of awareness and uptake. 

4. Conclusion

4.1    The Board is asked to:

• confirm the priorities for phase two 
• note the proposed timetable, particularly for the work on provision of information to consumers, including written information (this timetable will be further developed following scoping work this autumn)

Annex A - Programme Phase 2 Outline Roadmap

The five tables below present an accessible version of the Food Hypersensitivity Programme Roadmap.  The Roadmap represents the strategic intent of the food hypersensitivity policy unit in delivering the key themes discussed in the main body of this Board paper.  It provides headline activity titles and indicative start and end dates to give a broad overview of what could happen between the present time and March 2025.  Further programme deliberation and planning during the Autumn of 2022 will refine the activities and dates into an agreed baseline schedule against which the future programme will be managed, governed and judged.

Table One: Improve the application and effectiveness of precautionary allergen labelling (PAL)

Intended activity	Indicative start date	Indicative end date	Linked to subsequent activity
Planning and Business Case	15 July 2022	15 September 2022	Allergen Cleaning International Review of Standards - Develop Specification
Allergen Cleaning International Review of Standards - Develop Specification	20 July 2022	15 September 2022	Allergen Cleaning International Review of Standards – Tendering
Technical Guidance Content Update	20 July 2022	25 September 2022	Technical Guidance Update Devolved Administrations and DEFRA Consultation
Milestone for Codex Report on Allergen Thresholds Delivered	15 September 2022	15 September 2022	SERD Review of Codex Outputs
Allergen Cleaning International Review of Standards - Tendering	10 September 2022	07 December 2022	Review conducted
SERD Review of Codex Outputs	15 September 2022	10 March 2023	SERD Threshold Study on Non-Codex Priority Allergens
SERD Review of Available Tests for 14 Regulated Allergens	15 September 2022	10 March 2023	SERD Threshold Study on Non-Codex Priority Allergens
Technical Guidance Update Devolved Administrations and DEFRA Consultation	25 September 2022	05 March 2023	Milestone for PAL Technical Guidance Update Published
Review Conducted	10 December 2022	30 March 2023	Evaluate Evidence Gaps
Milestone for PAL Technical Guidance Update Published	30 March 2023	30 March 2023	Not Linked

Table Two - Consumer Information

Intended activity	Indicative start date	Indicative end date	Linked to subsequent activity
Planning and Business Case	15 July 2022	30 August 2022	Consumer Survey Tendering and International Review
Standardisation of Good Practice Guidance - Conversations (including PAL), Digital, Written and Confirmatory Actions		28 December 2022	Standardisation Guidance - Stakeholder Feedback
Planning and Business case	3 August 2022	13 September 2022	Develop 'Ask the Staff' signage
Online Aggregators allergen management and provision of information	5 August 2022	28 June 2023	ABC Dependency
Consumer Survey tendering	5 September 2022	5 December 2022	Consumer survey
Developing 'Ask the Staff' signage	5 September 2022	30 December 2022	User testing
International review	28 September 2022	10 January 2023	Recommendations for accurate provision
Qualitative LA focus events	25 November 2022	30 March 2023	Recommendations for accurate provision
Standardisation guidance - Stakeholder feedback	25 November 2022	20 April 2023	User testing
Consumer survey	7 December 2022	30 March 2023	Qualitative LA focus events
User testing	20 December 2022	5 May 2023	Develop supporting guidance
Barriers and context for business	2 January 2023	30 March 2023	Recommendations for accurate provision
Recommendations for accurate provision	10 February 2023	20 June 2023	Post-board planning
Develop supporting guidance	20 April 2023	15 September 2023	Milestone for Digital signage and guidance published
Refine standardisation guidance	1 May 2023	15 September 2023	Milestone for Standardisation guidance published
Post-board planning	10 July 2023	10 October 2023	Not linked
Milestone for standardisation guidance published	30 September 2023	30 September 2023	Not linked
Milestone for digital signage and guidance published	20 September 2023	30 September 2023	Not linked
Ongoing promotion of standardisation and signage with FBOs	1 October 2023	5 December 2024	Not linked
Evaluate need for FSA printed materials	20 October 2023	25 February 2024	Not linked

Table 3 Step change in knowledge, skills and safety culture within the non-prepacked sector

Intended activity	Indicative start date	Indicative end date	Linked to subsequent activity
Ongoing promotional opportunities for existing (FSA, Greater Gwent and CTSI) training resources	20 July 2022	30 June 2023	Not linked
Define target audience and requirements	5 August 2022	28 September 2022	Define level 1 content
Milestone for e-learning support contract renewed	15 September 2022	15 September 2022	Not linked
Define level 1 content	20 September 2022	18 November 2022	Develop potential delivery models
Develop potential delivery models	5 November 2022	28 December 2022	Define contract requirements and specification
Define contract requirements and specification	20 November 2022	30 March 2023	Business case
Safer Food Better Business and Safe Catering pack - FHS content improvement	25 November 2022	5 September 2023	SFBB project steering board dependency
Business case	15 January 2023	25 March 2023	Training provider tendering
Local Authority role in business support and enforcement	1 February 2023	25 August 2023	Policy recommendations
Training provider tendering	5 April 2023	25 June 2023	Design and develop level 1 training package
Milestone for contract award	30 June 2023	30 June 2023	Not linked
Design and develop level 1 training package	1 July 2023	30 January 2024	User testing and content refinement
Develop framework for Level 2 and 3	10 July 2023	25 September 2024	Produce level 2 and 3 framework
Policy recommendations	25 September 2023	15 January 2024	Not linked
Develop level 1 launch communications	28 December 2023	10 June 2024	Milestone for launch training
User testing and content refinement	5 February 2024	25 June 2024	Milestone for launch training
Evaluate training	15 June 2024	25 October 2024	Develop multilingual training options
Produce level 2 and 3 framework	1 July 2024	25 September 2024	Milestone for launch framework
Milestone for launch training	10 July 2024	10 July 2024	Not linked
Develop multilingual training options	15 August 2024	5 March 2025	Not linked
Milestone for launch framework	5 October 2024	5 October 2024	Not linked

Table 4 PPDS post-implementation review

Intended activity	Indicative start date	Indicative end date	Linked to subsequent activity
Implementation review tendering	5 July 2022	7 October 2022	Milestone for contract award
Milestone for contract award	15 October 2022	15 October 2022	Implementation review exercise
Implementation review exercise	15 October 2022	15 March 2023	Review final report
Review final report	20 February 2023	10 May 2023	Policy analysis of review findings
Policy analysis of review findings	5 April 2023	20 June 2023	Informs recommendations for accurate provision

Table 5 Data capture and survey

Intended Activity	Indicative start date	Indicative end date	Linked to subsequent activity
Scope and define periodic survey data and information requirements	25 July 2022	20 October 2022	Periodic survey tendering
Planning and business case	15 August 2022	20 September 2022	Periodic survey tendering
Periodic survey tendering	5 October 2022	28 December 2022	Milestone for contract award
Milestone for contract award	20 January 2023	20 January 2023	Create and endorse periodic survey
Create and endorse periodic survey	20 January 2023	30 June 2023	Milestone for launch inaugural survey
Milestone for launch Inaugural survey	15 July 2023	15 July 2023	Complete survey
Complete survey	15 July 2023	15 November 2023	Analysis of data
Analysis of data	5 December 2023	10 March 2024	Informs policy