FSA 22-06-07 Food Hypersensitivity (FHS) – Update on Workstreams and Recommended Next Steps

Report by Rebecca Sudworth, Director of Policy 

1. Summary

1.1 This paper updates the Board on the work carried out as part of the Food Hypersensitivity (FHS) Programme and the proposed approach for the next phase. 

1.2 The Board is asked to: 

Consider the progress of FHS work to date and note plans for the transition to phase two 

Endorse our proposed focus on three priorities for phase two: 

a) improving Precautionary Allergen Labelling (PAL) through a more standardised approach, more support for food businesses to apply PAL when necessary and improving allergen cross-contact risk management. 

b) a new workstream to improve allergen management and information to consumers in the 'non-prepacked' sector – i.e., food prepared on request in businesses such as restaurants and takeaways. 

c) continued focus on improving our understanding of the causes and impacts of FHS reactions. 

Note the options considered but not identified to take forward as priorities at this time, how we propose to meet the objectives for the workstreams in alternative ways and any further work required: 

a) A food allergy safety rating scheme for food businesses, similar to the FHRS scheme. 

b) Changes to the current legislative requirements on allergen information for non-prepacked food (but see recommendation on civil sanctions at 4.30). 

c) A central reporting tool for consumers to report 'near miss' reactions directly to the FSA. 

2. Introduction

2.1 The FHS Programme was established in autumn 2019 to deliver the objectives of the FHS Strategy, which aims to improve the quality of life for people with FHS.  At the heart of our approach is working with businesses and consumers to bring about a culture change in how allergies and intolerances are managed.  Both businesses and consumers have a responsibility to understand and manage risk, supported by the legislative framework, the best science and evidence and the right guidance and support. 

2.2 In phase one of the Programme, we prioritised work on the implementation of the new labelling requirements for prepacked for direct sale (PPDS) food which were introduced from 1 October 2021 across the UK. We also tested a central reporting tool for consumers to report 'near miss' reactions, investigated options for a food allergy safety rating scheme for businesses, and conducted research and scoping work on two further potential workstreams – improving PAL and improving allergen management and information for people with FHS in the non-prepacked sector. 

2.3 In June 2021 we updated the Board on progress.  We have completed work to implement the new labelling requirements for PPDS food.  A formal evaluation of PPDS implementation will take place from October 2022 and we will update the Board in 2023 on the findings and any lessons learned that could inform future allergen labelling policy.  The results of early survey work with food businesses and local authorities are outlined at Annex A, together with a brief report on other workstreams not discussed in detail in this paper.  

2.4 In 2021 we established an expert panel to support our engagement with external organisations involved in work on FHS, and to provide feedback and comment on the FSA's approach to the FHS Programme.  The panel has met four times and we are grateful for the input we have received, which has informed our approach.  Membership of the panel is outlined at Annex B. 

2.5 Since 2010, the FSA has played a leading role in understanding the causes and impact of food hypersensitivity, and the mechanisms through which risk may be avoided or managed.  Working with partners in the health services, academia and in government we will continue to explore how we can improve our understanding, targeting our efforts on building an evidence base that will inform future policy.  The annexes to this paper summarise the research and scoping work that has informed our recommendations about the approach for phase two of the FHS Programme, including findings from research currently being prepared for publication. 

3. Precautionary Allergen Labelling (PAL)

3.1 Feedback from businesses and consumers suggests that PAL is confusing and can be applied inconsistently.  We have carried out research to explore stakeholder views on the application and interpretation of precautionary allergen labelling and information including the 'May contain' consultation, which ran from December 2021 to March 2022, and social science research with businesses and consumers (see Annex C for a summary of the findings). 
 

3.2 The research has highlighted the need to keep consumers safe without unnecessarily limiting their food choices, whilst ensuring solutions are workable for food businesses.  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. 

Proposed activities

1. Working towards a standardised system for applying precautionary allergen label to prepacked food products

Food business want a standardised approach, with clear requirements that provide certainty and a level playing field, giving confidence that their risk assessments protect consumers.  Consumers want PAL statements on food products be trustworthy, meaningful and to enable them to understand the risk that that is being conveyed. 

Examples of activities being considered are: 

• setting of allergen threshold standards: we will review emerging evidence to establish whether best practice or legal allergen thresholds could be set for some or all of the 14 regulated allergens, for the purpose of establishing a level of allergen cross-contamination above which a PAL should be applied.  
• an update of technical guidance to provide a best practice format and wording for PAL statements.  

2. Supporting small and medium-sized enterprises (SMEs) to do the right thing 

Generally, the smaller the business, the greater the challenge in applying PAL. This is due to a lack of understanding of responsibilities – with risk assessment/management decisions often shaped by wider food hygiene practice and heuristics (rules of thumb/ 'how things are done around here'). 

Examples of activities being considered are: 

• expanding Safer Food Better Business (SFBB) guides to incorporate PAL: SFBB is our most popular business information page (with at least 368,500 hits in 2021) that details food safety regulations and management procedures for SMEs. Our research has shown there is support for this combined approach (rather than creating separate PAL guidance) to provide a one-stop shop source of information for SMEs. We will also consider how to update relevant content in the Safe Catering guides for businesses in Northern Ireland. 
• producing sector-based decision tree guides for local authorities: to make it easier for local authorities to ask informed questions and steer food businesses into compliance. 

3. Improving allergen cross-contact risk management and communication in the non-prepacked sector 

The non-prepacked food sector faces particular challenges due to the nature of the environment food is prepared in, for example, confined spaces, with all (or almost all) allergens present in the food production space, without input from a trained allergen specialist.  

Examples of activities being considered are: 

• advice on conversations with people with FHS: information to guide staff serving non-prepacked food through the questions they should ask customers with FHS; information they should provide on allergen cross-contact; and risk management steps they could take to further control or remove this risk. 
• working with the non-prepacked sector to develop specific training. 

4. Allergen information and management in the non-prepacked food sector

4.1 Our policy aims for the non-prepacked food sector are:  

• people with FHS have access to reliable allergen information enabling them to make informed choices when buying non-prepacked food and have confidence that the food they choose will be safe. 
• food businesses have the skills and knowledge to provide accurate allergen information and manage allergens effectively.    

4.2 We have examined different approaches for achieving this aim including the potential of a food allergy safety scheme; improving the provision of allergen information to consumers; and improving training for businesses. 

4.3 For people with FHS, confidence that the non-prepacked food they are purchasing will be safe is dependent on two things: the information they receive from the food business about the allergens in the food; and how the food is prepared.  Safety is dependent on the accuracy of the information provided by the food business, and the steps taken to manage the allergen cross-contact risks associated with the individual’s FHS requirements.  Consumers have different requirements depending on the severity of their FHS. 

4.4 The non-prepacked food sector encompasses over 100,000 diverse food businesses from restaurants, takeaways and mobile food vans to delicatessens, caterers and hotels with diverse operating models. This makes it difficult to adopt a single solution or approach to allergen information and management, and to apply this effectively across the whole sector.  Our research indicates that people with FHS and food businesses would like greater consistency in approaches to the provision of allergen information and the application of allergen management processes. 

Assessing the potential of a food allergy safety scheme (FASS)

4.5 The FSA Board asked for the possibility of a FASS to be examined, potentially similar to the Food Hygiene Rating Scheme (FHRS), that would provide an ‘at a glance’ allergen rating via a sticker on the door to enable people with FHS to make decisions on where to eat.  The policy model underpinning this approach is information-based regulation. 

4.6 We provided updates to the Board on our initial scoping work in December 2020 and June 2021.  Following those updates we examined different potential options, including the feasibility of linking with FHRS, and tested them with consumers and businesses.  A summary of the work undertaken to assess different options for a FASS is outlined at Annex D.      

4.7 The evidence shows that information-based regulation model is unlikely to be effective for allergens.  This is because of the nature of the risk (information-based regulation is less effective for managing higher risks) and because people with FHS are advised to seek specific information about a food business based on their personal requirements before making choices about what and where to eat.  The low demand from consumers and businesses for such a scheme has been demonstrated through the market with different schemes failing to fully launch or expand.  

4.8 A sticker on the door similar to, or as part of, the FHRS sticker may increase the overall confidence of people with FHS in a food business.  However, it will not give the level of detailed information that they need to enable them to effectively assess allergen risks for their own hypersensitivity.  People with FHS have indicated they would still need to carry out their own personal checks on a business before deciding whether to eat there.  Local authorities also express concern about providing consumers with a verdict on allergens based on a ‘moment in time’ assessment. 

4.9 Given the uncertain benefits to consumers or food businesses and the increased input required from local authorities, we consider it would be disproportionately costly to set up a scheme.  There would also need to be a fundamental restructuring of how environmental health and trading standards functions work in local authorities to align their respective work to support an allergen rating scheme.  We recommend that this option is not taken forward at this time. 

The provision of allergen information to consumers in the non-prepacked sector, including consideration of changes to current legislative requirements  

4.10 Ensuring that consumers have clear and accurate information that will enable them to understand and manage risk is a fundamental pillar of our FHS strategy and remains a priority for the FSA.  We have looked at existing evidence and commissioned new research to understand consumer and food business views on how allergen information is provided in the non-prepacked food sector, and to understand their respective needs and preferences. 

4.11 Our recent research includes an assessment of proposals put forward by the Owen’s Law campaign focusing on provision of allergen information (see Annex E).  More information about the Owen's Law campaign and the FSA's role when deaths from food-related anaphylaxis occur is at Annex G.  The FSA strongly supports the campaign objective to improve the provision of information to consumers when eating out, including better training for food business staff.  We are grateful to the Carey family for raising awareness of the importance of accurate allergen information when eating out, and have considered their proposals carefully, including the case for changes in the law. 

4.12 The legal requirements that apply to the provision of allergen information for non-prepacked food (introduced in 2014) specify that information on the presence of the 14 regulated allergens must be provided to the consumer, and this can be in writing or verbally.  Existing legislation is clear that this information must be signposted to the consumer and must be accurate.  Most European countries follow a similar approach. 

4.13 Our ongoing research on the provision of allergen information suggests that in the last five years, there has been a positive shift in food businesses’ attitudes to catering for people with FHS, and people's experience of purchasing and eating non-prepacked food has improved significantly.  Key findings include: 

• 95% of businesses have an allergy policy. 
• 95% of businesses use both written and verbal means of communicating information about allergens to customers. 

From the range of written and verbal methods of providing information about allergens: 

• 20% of businesses display written information on the 14 regulated allergens on menus. 
• 30% use an allergen matrix. 
• 21% require staff to proactively ask about allergens. 

4.14 Our new research shows that both verbal and written allergen information is important for people with FHS and businesses, although for each group there is a different focus.  For people with FHS written information is key as they want to be able to make decisions, feel in control, and have a ‘normal’ experience when eating out.  Businesses feel that verbal communication is the most important way of interacting with the consumer (particularly as they need to amend the process in the kitchen to be certain to avoid cross-contact). 

What needs to change? 

4.15 The progress highlighted in paragraph 4.13 is encouraging, but our research shows that there is more to do to ensure that allergen information is clear, accurate and easy to use, and that food businesses in the non-prepacked sector have the skills and support to ensure that allergens are effectively managed.  Our evidence shows that achieving a step change in the provision of information in the non-prepacked sector will require system-wide focus rather than concentrating on just one or two steps in the process. 

Views of people with FHS

4.16 People with FHS say that written information supported by verbal communication is the most trusted way they access allergen information.  There are some instances where they consider verbal communication more important, for example, for those with a severe FHS or when they are in unfamiliar settings. 

4.17 People with FHS wish to see increased standardisation in how allergen information is presented, although they do not want to see menus overcrowded with information and want food businesses to have flexibility of design to fit in with the business’ style.  People with FHS do not necessarily wish to see all 14 regulated allergens listed on menus.  They prefer information on menus to show them what they can eat rather than what they cannot eat, for example, food being labelled as ‘dairy-free’ rather than ‘contains milk’.  This makes it easy to quickly scan a printed or digital menu and find suitable dishes.  Where information is not provided on a menu the preference is for alternative written information, which is clearly presented and quick to navigate, and is provided before the decision-making process commences. 

4.18 People with FHS also want food businesses to ask each customer about their allergen requirements; this is supported by a small trial we conducted in 2020 that showed that when people with FHS are asked proactively about allergens it increased their trust in the business and food safety, and their customer satisfaction. 

The context of the non-prepacked food sector 

4.19 Food businesses are positive about the provision of written allergen information on menus and in an allergy matrix, and proactively asking consumers about allergies.  A quarter of businesses do not anticipate any challenges implementing these three measures (although these businesses are more likely to be large businesses), and some businesses only anticipate short-term challenges in adapting to them, however it is clear that many businesses find the provision of written information more challenging and need more support. 

4.20 The risk of cross-contact while food is being prepared is an important reason for consumers to not rely on written information alone.  A greater focus on written information could mean a consumer is less likely to have a conversation with the business about their FHS needs and how the food preparation process can be adapted to them.  The absence of an allergen in a dish as listed on a menu does not necessarily translate to the absence of an allergen in the food served, unless cross-contact risks are understood and managed when the food is being prepared. Some large businesses (see Large Chains research summarised at Annex F) purposefully do not include allergen information on their menus, as they want to encourage a conversation with consumers.  They believe this approach works well in providing people with FHS with correct allergen information. 

4.21 The specific context that non-prepacked businesses operate in means that for many businesses written information will quickly become out of date.  These businesses are operating in a continuous service model, and generally in a more fluid and dynamic context than those businesses selling some form of ‘prepacked for direct sale’ food (although some businesses will sell both non-prepacked and PPDS food).  Businesses that make prepacked items in advance of orders will be able to control the ingredients and environment the food is prepared in, to limit cross-contact.  The risk is that people will place particular reliance on written information for non-prepacked food when we know there is a higher risk that this may not be accurate.  For example, some businesses change their menus very frequently, some will regularly source ingredients from different suppliers (so have a less predictable supply), and many will make last minute ingredient substitutions. 

4.22 The focus in these situations should always be to provide accurate allergen information, whether that is in writing or verbally.  If a business cannot provide accurate written information it is better that this information is provided accurately and verbally, rather than incorrect information being presented to customers on a written menu.  (To note, Ireland introduced a legal requirement for allergen information for non-prepacked food to be provided in writing in 2014, and a subsequent audit in 2017 indicated that compliance was low.  Of the 68% of businesses that did provide written allergen information, 76% provided inaccurate information.) 

Policy options for improving the provision of information in the non-prepacked sector

4.23 We have considered a range of options for improving the provision of information in the non-prepacked sector, focusing on the following aspects: 

• ensuring that food business staff have the right training and skills to manage allergens effectively. 
• ensuring that information provided is accurate, whether given in writing or verbally. 
• greater standardisation of written allergen information, making it easier to interpret and to use. 
• encouraging dialogue between food businesses and consumers, particularly asking about allergens at the point of order. 
• enabling enforcement officers to support businesses to meet legal obligations, and more effective penalties when the law is broken. 

4.24 Our proposals for work to be taken forward in phase two of the FHS Programme are set out at paragraph 4.30 below. 
It is already a legal requirement that businesses must provide accurate information about the fourteen allergens, either verbally or in writing for non-prepacked food.  We have considered the case for changes to the law to mandate that allergen information must be given in specific formats, and to strengthen the responsibilities of food businesses in the non-prepacked sector.  In particular, we have carefully considered the proposals from the Owen Carey campaign to mandate the provision of allergen information on menus through symbols or words for the 14 regulated allergens, and to make it the law that staff must ask the customer about allergens. 

4.25 Given the findings from our recent research summarised above, we do not recommend making it a legal requirement to have allergens denoted by symbols or words on menus.  However, we agree that where businesses can provide allergen information on menus safely they should be given more support to do so. The FSA will do more to provide best practice examples and encourage a standardised approach.  In particular, we will explore standardised written messaging that explains how people with FHS can get information (for example, 'ask the staff' signage'), and we will consider strengthening the legal requirements about how this messaging should be displayed. 

4.26 Given the increasing numbers of non-prepacked food businesses selling food online, and the increasing importance of online food aggregators, we will ensure our training and guidance includes good practice on selling food online.  We will also work with online aggregators to further develop their allergen policies (see 4.30). 

4.27 We agree that proactively asking consumers about allergies is best practice, and consumers and businesses are both positive about this approach.  Narrowly targeted legislation to mandate this is unlikely to be effective because it is very difficult to legislate for and enforce an interaction between individuals, particularly as any investigation would take place some time after the event and the context for the interaction would vary widely between different business models.  In many non-prepacked contexts, ordering may be done online (while the consumer is within the food premises) with no, or minimal interaction with serving staff, and it is important that approaches to protect consumers are future-proofed and cover the full range of non-prepacked settings.  In addition to our work on 'ask the staff' messaging, we will work with the non-prepacked sector and with local authorities to develop a structured package of training for staff to ensure they have the skills and knowledge to communicate effectively for customers.  This will include tailored content for front-of-house staff.  We will also explore staff training on allergen management and whether, in future, allergen training for staff in certain roles should be made compulsory.   

4.28 We will work with local authorities as we take forward the plans outlined below, including considering the introduction of civil sanctions and penalties to give enforcement officers a greater range of tools to take swifter and more effective action when breaches of food safety requirements relating to allergens occur. 

The need for training in the non-prepacked sector

4.29 We have given training a high priority in our proposals because this supports the whole-system approach that will ensure all staff members in non-prepacked establishments understand the importance of good allergen management and are aware of their legal responsibilities.  Our 2020 research found that only 49% of non-prepacked food businesses had received formal training on food allergens, clearly demonstrating that there is more to do to ensure that businesses have access to and take up high quality training. Our new research indicates that training is particularly needed in the current challenging context, as the sector recovers from the impact of the Covid pandemic.  Businesses want to learn about ‘best in class’ models and both businesses and people with FHS wish to see increased standardisation in approaches.  Our proposals for a tailored, structured series of training packages will ensure that training is focused on the end-to-end process of food preparation from the moment of ordering to the point of service and practices in the kitchen after the meal is over. 

4.30 Our detailed proposals for improving the provision of allergen information in the non-prepacked sector are set out below.  There is a high degree of consensus from people with FHS and from businesses about what needs to change.  Although we do not propose changes to the law at this time, we do not rule this out in future, and we will ensure that we evaluate and learn lessons from the next phase, together with the evaluation from the implementation of the PPDS changes. 

Proposed activities to deliver change in the non-prepacked sector

1. A comprehensive review of the allergen content on the food.gov website to make it clearer and easier for food businesses to understand 

• ahead of the development of new training and guidance we will make changes to the existing allergen content on the FSA website.  
• Research shows that 18% of food business operators turn to the FSA helpline for information about food safety guidelines and regulations.
• There is an opportunity to make it easier for businesses to access the information they need through greater clarity on the website, which will likely to reduce the calls directed to the helpline.  We aim to complete this work by December 2022. 

2. Continuing to encourage essential safety conversations about allergen requirements through improving the consistency and messaging of the 'ask a member of staff' signage  

• There is a legal requirement, if allergen information is not provided upfront in writing, for food businesses to clearly indicate how allergen information can be obtained for non-prepacked food.  Food businesses use different methods to convey this including notices on menus and signs or posters advising consumers to ask staff.  
• A standardised message tested well with consumers and food businesses in our research.  Consumers would like the messages to be clearer and more consistent so that they feel more confident to discuss their allergen requirements with staff.  For adults, feeling comfortable asking staff for information when eating out correlates with better quality of life. 
• We will also provide guidance on how this signage is best formatted and placed within the food business, so the information is as clear as possible, and is prominent so consumers can see it. 
• As part of this further work, we will consider strengthening the legal requirements about this messaging. 

3. A structured, online training programme for staff in different roles within food businesses, with progressively more specialised content for senior staff. 

• Only half of food businesses have received formal training on food allergens. Providing training that focuses on behaviour change as well as knowledge will help to make it easy for food businesses to consistently meet the needs of people with FHS.  
• Level 1 would be aimed at all food business staff with a particular emphasis on front-of-house staff and those who have interactions with customers to: ensure that they understand allergens and their importance; develop effective interpersonal and communication skills; understand the legal landscape; and know how to respond in an allergen emergency. 
• Level 2 would provide additional, detailed good practice processes and how to manage problems (such as supply chain issues).  This level would be aimed at junior management staff and chefs.  
• Level 3 would focus on leading and developing allergen management within the business and would be aimed at head chefs and more senior managers.  
• The training would include certification on completion of each stage of the training to ensure full understanding of the material. 
• We aim to complete the development of this training programme by December 2025. 

4. Sector specific guidance for food businesses on allergen management and information good practice as part of wider FSA work to update and enhance Safer Food Better Business (SFBB) and Safe Catering resources 

• Our SFBB guidance is a resource that is trusted and widely used by food businesses, alongside the Safe Catering guidance tailored to businesses in Northern Ireland.  We will work to produce sector specific guidance on both hygiene and allergens, that will enable different kinds of businesses to obtain good practice advice that is tailored to them for example, school caterer, restaurant, or mobile food van.  

5. Strengthening enforcement capability through exploration of how civil sanctions, such as fixed-penalty notices, could be used 

• Current criminal prosecutions relating to allergen information and management are hard to mount because they are resource intensive and financial penalties are relatively small.  The burden of proof is also greater than in the civil courts.  A civil sanction would assist local authorities in their enforcement role in respect of consumer information regulations.  
• For food businesses such sanctions would provide a strong financial incentive for compliance and elevate the importance of allergens. Research shows that food businesses become more engaged with allergens when they hear about consumers experiencing allergic reactions and prosecutions taking place against other businesses.  
• The feasibility of this option requires further exploration, and we recommend carrying out this work and reporting back to the FSA Board later this year for a decision on how to proceed. 

6. Work with the FSA’s Achieving Business Compliance (ABC) programme to further develop allergen management policies amongst the online aggregators    

• Recent research we have conducted (through the Small and Micro Business tracker) indicates an increased online presence amongst food businesses selling non-prepacked food:  

60% have a website and 23% take food or drink orders via their website. 

71% have a social media presence and 14% take order via social media.  

20% of food businesses use third party platforms to sell food and drink.  

• We will ensure that our training and guidance includes good practice information when selling food and drink online.  We will also link with the FSA’s ABC programme Online Assurance Workstream.  This work is being developed with the big-three aggregators (Just Eat, Deliveroo and Uber Eats) to explore the concept of a Voluntary Food Safety Charter that is scalable for smaller aggregators and is robustly governed. 
• In addition, the ABC programme is exploring the FSA’s position as a convenor and collaborator, thinking about how to best work with all different types of online businesses involved in the facilitation of food sales.  This will help to identify where we can add assurance to priority areas of risk including FHS.  

7. Evaluation 

As part of our work we will develop robust evaluation plans to assess the effectiveness and impact of our activities using the FSA’s survey work including The Food Industry’s Provision of Information research as a baseline. (This research was carried out in 2020 and indicates how the provision of allergen information has improved since the 2014 legislation was introduced.)

5. Improving our understanding of the causes and impacts of FHS reactions

5.1 As part of phase one of our FHS work we have been looking at how we can improve our understanding of the extent and nature of FHS reactions, particularly when people with FHS are buying food outside of the home.  

5.2 We carried out Proof of Concept (PoC) testing of a food allergic reaction reporting mechanism (FARRM) which would enable consumers to self-report allergic reactions.  The PoC was live on food.gov for 4 months from November 2021 and consisted of a web form to collect data from consumers to which there were links on several partner websites and social media platforms (see Annex H for a summary of the work):  

• the PoC highlighted potential issues with the FARRM tool relating to data validity, and consumer and stakeholder expectations for data sharing.  There were also wider considerations as to how consumer awareness and motivation to use the tool could be sustained over the long term.  
• the work concluded that alternative methods of collecting data on the nature and number of FHS reactions and near misses should be explored and the FHS policy team are considering the viability of a establishing a regular FHS survey to capture the required information.   

5.3 The FSA is supporting work on the UK Anaphylaxis Registry which launched on 7 October 2021.  The registry serves as a platform for health care professionals to record details of anaphylaxis incidents.  The study team are working on collating data from the registry to provide a better picture of the type of reactions occurring, their frequency and their geographic spread.   

5.4 Work  continues on the Patterns and Prevalence of Adult Food Allergy (PAFA) research project which aims to provide improve our understanding of food allergy in adulthood by determining its prevalence in the adult population. 

5.5 We are carrying out work to estimate the financial costs and non-financial burden of FHS using field surveys and WTP methodology including measures of quality of life for FHS consumers.  These estimates will be used to populate a Cost of Illness model related to food allergies, food intolerance and coeliac disease. 

6. Recommendations

6.1 The Board is invited to: 

Consider the progress of FHS work to date and note plans for the transition to phase two; 

Endorse our proposed focus on three priorities for phase two: 

a) Improving Precautionary Allergen Labelling (PAL) through a more standardised approach, more support for food businesses to apply PAL when necessary, and improving allergen cross-contact risk management

b) A new workstream to improve allergen management and information to consumers in the 'non-prepacked' sector – for example, food prepared on request in businesses such as restaurants and takeaways. 

c) Continued focus on improving our understanding of the causes and impacts of FHS reactions. 

Note the options considered but not identified to take forward as priorities at this time, how we propose to meet the objectives for the workstreams in alternative ways and any further work required: 

a) a food allergy safety rating scheme for food businesses, similar to the FHRS scheme

b) changes to the current legislative requirements on allergen information for non-prepacked food

c) a central reporting tool for consumers to report 'near miss' reactions directly to the FSA. 

Annexes

• Annex A – Summary of progress on other FHS workstreams 
• Annex B – FHS Programme External Expert Panel Membership 
• Annex C – Summary of PAL research and consultation findings  
• Annex D – FASS research 
• Annex E – Provision of information in the non-prepacked sector research  
• Annex F – Allergen management in large chains research 
• Annex G – Owen's Law campaign and the FSA response 
• Annex H – Improving our understanding of the extent of FHS reactions

1. Implementation of prepacked for direct sale (PPDS) allergen labelling requirements – early survey results 

In October 2021 new legislation requiring the labelling of PPDS foods came into effect.  This legislation, also referred to as ‘Natasha’s Law’, requires all businesses selling PPDS foods to label these foods with the food name and a full list of ingredients, with allergens highlighted (for example, written in bold text). 

A full evaluation of PPDS legislation implementation is planned to begin from October 2022.  In the interim, we have been monitoring changes in awareness and compliance with this new legislation, compared against baseline data gathered in 2020, through our ongoing tracking work, a light-touch ‘temperature check’ survey with food businesses selling PPDS foods and feedback from local authorities. 

These activities were intended to act as an early warning system should implementation not be going well, rather than to robustly measure compliance.  However, they indicate the direction of travel for awareness and compliance, with early signs that both have improved since October 2021.  That said, these data also suggest that further work is needed to enhance and support awareness and compliance among micro and small businesses. 

Awareness has risen from around two thirds of food businesses selling PPDS foods to between eight and nine in ten of businesses.  

• our baseline research found 64% of businesses selling PPDS foods were aware of the upcoming change in legislation in 2020. 
• findings from Wave 3 of our Small and Micro Business tracker which collected data immediately after the introduction of PPDS in October 2021 (fieldwork took place in November to December 2021), found 79% of micro and small businesses selling PPDS foods (n=175) were aware of the law. 
• data from our independently recruited temperature check survey with 150 businesses selling PPDS foods (fieldwork in 25-29 March 2022) found 95% of respondents were aware, although we need to consider the sample size and an over representation of respondents with multiple sites (1 site: 11%; 2-4 sites: 43%; 5-10 sites: 31%; 11+ sites: 15%). 

Compliance has also improved from six in ten businesses labelling all ingredients to eight in ten labelling all ingredients.  

• our baseline work in 2020 found that 62% of food businesses selling PPDS foods were labelling all ingredients and 78% were labelling all allergenic ingredients ahead of the new PPDS requirements. 
• findings from our recent temperature check survey with 150 food businesses selling PPDS foods found 81% respondents labelled all ingredients, with a further one in ten (9%) labelling allergenic ingredients only. 

Local authorities appear to find interpreting, understanding and enforcing PPDS legislation manageable, although they have common concerns about compliance among micro and small businesses 

• we asked environmental health (EH) and trading standards (TS) teams in local authorities (in England, Wales and Northern Ireland) for their views on enforcement and also compliance amongst FBOs of different sizes.  At the time of writing, the FSA had received 92% of returns from EH teams and 89% of TS teams.
• 13% of TS teams and 16% of EH teams found it difficult or very difficult to interpret and understand the PPDS legislation. 

In comparison 87% of TS teams reported their officers found interpreting and understanding PPDS legislation neither easy nor difficult (44%) or easy/very easy (43%).  The figures were similar for EH teams, with 49% reporting it was neither easy nor difficult (49%) or easy/very easy (35%) to interpret and understand the PPDS legislation. 

• 18% of TS teams and 22% of EH teams found enforcement difficult or very difficult.  

In comparison 51% of TS teams found enforcing PPDS legislation neither easy nor difficult with a further 31% finding enforcement either easy or very easy.  Figures for EH teams were slightly lower with half (49%) finding enforcement neither easy nor difficult and just under three in ten (29%) finding it easy/very easy. 

• TS and EH teams both had concerns about levels of compliance among micro and small businesses, and far less concern about the compliance of large food businesses: 

80% and 72% of TS and EH teams respectively had concerns about micro businesses. 

63% and 58% respectively had concerns about small businesses.  

19% and 11% respectively had concerns about medium sized businesses. 

Just 5% and 4% respectively had concerns about large food businesses. 

We expect that the planned evaluation of PPDS implementation will enable us to robustly measure levels of awareness and compliance amongst a representative sample of PPDS food businesses, capture patterns in awareness and compliance across nations and business size/type and will identify barriers and facilitators to compliance.  We will also consider the views of local authorities and data on actions they have taken on PPDS.  This will enable the FSA to consider what further guidance and resources might be needed to support compliance.  

3. Programme stakeholder engagement and campaigns 

We have continued to deliver programme stakeholder and communications activity: 

• in March 2022 we launched a new ‘Speak Up For Allergies’ campaign aimed at young people and food businesses – this followed on the success of the first campaign in spring 2021.  It is designed to encourage young people to support friends with allergies when eating in restaurants, as well as highlight the important role front of house staff have when a young person with allergies dines in a restaurant. 
• the 3rd FHS Symposium took place in March 2022 - a virtual FHS symposium for approximately 600 delegates.  
• the FHS programme expert panel have provided input to a range of programme activity including the design and content of the PAL consultation. 

4. Enhanced Training  

A 2020 FSA survey looking at the provision of allergen information to consumers within the food sector highlighted that only half of food businesses had received formal training (49%), with a lower uptake amongst smaller businesses.  Whilst this had increased from 2012 (34%), there appears to be some way to go to achieve greater coverage. 

To understand how the uptake of FHS training can be improved or enhanced, and what role FSA can play in this process, the FSA commissioned a desk-based scoping research exercise to investigate the current extent of FHS training available to UK food businesses. 

A Rapid Evidence Assessment identified18 pieces of literature related to UK provision of FHS training and 7 related to international recommendations for improvements to training: 

• the literature identified a lack of resource from many companies in being able to facilitate FHS training due to the long hours worked across food service staff and economic constraints exacerbating the problem. 
• the dissemination of training within businesses and poor communication was often found to be a barrier to lower-level staff accessing FHS training in many small and medium-sized businesses. 
• the use of more behavioural-based, rather than knowledge-based training alone, to increase motivation and uptake by staff was also identified as a key area to explore.   

Workstream objective

Gain feedback from business and consumers on to better understand the application and interpretation of PAL and gather evidence which will assist us to further consider the potential for developing policy interventions.   

Workstream approach

The FHS policy team and Science and Evidence Team have worked together to commission 3 pieces of research.   

The outputs of this work, along with the findings of the Enhanced Learning workstream, and further input for stakeholders such as the FHS Programme Expert Panel, have been used to inform the 3 PAL workstreams (and associated activities) set out in the main paper: 

Key research findings

1. Social science study with food businesses:  

A qualitative study was undertaken with 60 SMEs, including food businesses from each key food business sector, to explore experiences, interpretations, and views of PAL: 

Smaller food businesses reported a general lack of understanding of their responsibilities, and of the distinction between the regulatory requirements of general allergen labelling (mandatory) and PAL (voluntary). 

• This was found across SMEs and in all sectors, though food manufactures, institutions, and retailers had a better understanding while small/micro business and caterers reporting a lower understanding. 

For SMEs, PALs are often applied because businesses are not sure that their food is without any cross-contamination risk following risk management actions, including cleaning and segregation, because without allergen testing there is no validation. 

• This uncertainty increased through the supply chain with food businesses often taking suppliers PAL labels at face value and passing the information on to consumers. 
• In establishments serving non-prepacked food, the risk of cross-contact was seen by participants as almost inevitable, due to the wide variety of ingredients used and the busy nature of kitchens.  

SMEs tend to think about allergen risk management and communication, including the use of PAL, in the context of wider food hygiene practices and especially microbiological risk management.  

• Certain food hygiene practices that also help to reduce allergen cross-contact were commonly adopted.  However, food delivery, storage, and serving are all weaker spots of allergen cross-contamination management. 

SMEs typically have a high level of confidence in their allergen cross-contact management practices, despite them rarely being preceded by a through risk assessment of where key allergen cross-contact points are.   

• Informal heuristics often shaped decision making and practice in relation to allergenic ingredients, with peanuts, gluten, milk, and eggs readily coming to mind and being perceived as ‘riskier’ than other allergenic ingredients (especially celery and lupin).  

Food business identified a range of barriers to the adoption of PAL. 

• Poor knowledge of PAL; a lack of common standards for risk analysis and easy an inexpensive means of measuring thresholds; limited expertise and confidence in decision making around cross contamination management (greater for caterers); and practical issues. 

2. Social science research with consumers:  

A qualitative consumer perception study with 30 people with FHS: 

People vary widely in how they appraise the risk posed by food products provided with a PAL or precautionary allergen information, driven by differences in severity of response, length since diagnosis, health status, personality, and other factors. 

• There is a widespread assumption that PAL is mandatory: people often assume that if a product does not include a PAL notice, it has been determined that it is without cross-contamination risk (i.e., a risk assessment has been carried out).  This may lead to some people taking on more exposure risk than is comfortable or safe for them. 

Although most people are aware of PAL, understanding of what it is meant to communicate is low and determining cross-contamination risk when eating can often be a highly stressful experience.  

• In general, people judge PAL not as communications meant to benefit the public, but as legal ‘cover’ for businesses in the case of accidental consumer harm.  
• PAL is widely judged to be ‘confusing' and vague.  Some were not even aware that PAL communicates cross-contamination risk.  

Consumers want to know who PAL is for. 

• Consumers want more information about who messaging is for: whether it is for people with serious hypersensitivities, people with mild hypersensitivities, or people avoiding certain ingredients for lifestyle reasons or dietary preferences rather than health risk. 

3. The PAL “may contain” consultation:  

Consisting of an online portal, 15 workshops (with representatives from trade bodies, large food businesses, local authorities, scientists and academics), and detailed emailed qualitative responses from 30 stakeholders. 

2459 online responses to the consultation were received: 84% of these were consumers (97% of which had or cared for someone with an FHS); and 11% were food businesses (there were at least 30 responses from each key food business sector).   

Theme One - Provision of Information to Consumers.  The aim was to gain views on the consumer preferences in respect to PAL wording and format, and the potential for the provision of additional information e.g., via an app or website: 

There was strong support for the standardisation of PAL on prepacked foods. 

• “Not suitable for consumers with an allergy to [allergen]” is the preferred statement – 68% thought it effective (and preferred by both businesses and consumers).  Only 47% found “may contain” effective.  

There was a lack of support for the provision of additional information on why a precautionary allergen label was applied to become standard practice, but it was recognised that it should be information individuals can request. 

• Whilst understanding why consumers might wish to know more detail, there were a range of practical issues identified and (with exception of consumer advocacy groups), stakeholders also challenged the idea such information would help consumers make better food choices.  

Theme two - Advice and Training for Food Businesses.  The aim was to consider impact of current provision of advice and guidance on PAL application and the potential need for additional material: 

All businesses said that they undertook training specifically on allergen management and labelling, though specific trading on PAL labelling was less common. 

• Training provision was from a variety of sources, with in-house training the most common approach for larger businesses, and through trade organisations and membership bodies for smaller businesses. 

Only 25% of respondents thought that there was adequate advice provision currently.  There was generally a good awareness of FSA materials, but not the new PAL guidance. 

• At workshops, stakeholders emphasised that local authorities are the trusted source of advice on the ground – and FSA activity should focus on helping them to provide it. 

Theme three - Ensuring Compliance.  The aim was to gain views on how PAL Should be applied and regulated including legal interpretation of current regulations:  

Most stakeholders supported FSA legal interpretations of FICR (Food Information Consumer Regulations) and were in favour of amendments to FICR for greater clarity. 

• There was strong agreement with the legal interpretation that there could be a breach of FICR if: a PAL does not specify the allergen; a PAL and ‘Free-from’ are both used on a label; if a PAL is applied without assessing unavoidable risk of cross-contamination.  

Theme four - Standards for Risk analysis of Allergen Cross-contamination.  The aim was to identify options to increase consistency in the assessment and management of the risk of allergen cross-contact. 

Stakeholders supported standardising risk-analysis (the steps which food businesses take to assess, control and communicate any allergen cross-contact), but also recognised how challenging this is given the variability within and between food sectors. 

• 93% support for standardising information regarding the risk of allergen cross-contamination within supply chains and 81% for setting a standard for allergen levels to guide PAL application for prepacked foods.  

Workstream objective  

People with FHS have access to reliable allergen information enabling them to make an informed choices when buying non-prepacked food and have confidence that the food they choose will be safe.   

Approach to the workstream  

• We have been exploring if an information-based regulation scheme for allergens, referred to here as a potential ‘Food Allergy Safety Scheme’ (FASS), would be the best way to achieve our non-prepacked food sector workstream objective.  
• In our assessment we have considered the policy model that underpins information-based regulation and examined different options for delivering a FASS scheme, including combining with the existing Food Hygiene Rating Scheme (FHRS).   
   

Key research findings

1. Policy model underpinning a Food Allergy Safety Scheme (FASS) - Information-based Regulation  

Information-based regulation refers to schemes where information is used to drive behaviour change to achieve social, environmental or public policy objectives.  Some schemes are voluntary, others have a legislative basis3.   

Whilst this model has been successfully applied to food hygiene there are challenges to applying the same model effectively to allergen management and the provision of allergen information:   

Risk Level - People with FHS have individual and often complex requirements and allergens present different levels of risk for each individual ranging from low to very high.  This is a challenge for food businesses who cannot apply a universal approach in the same way as they would for hygiene requirements or dietary preferences.  

Consumer Interest - Generating the high levels of consumer interest necessary for effectiveness may be challenging, given the scheme will be specifically of interest to people with FHS and their friends and family, rather than the general population.  This is reflected in the fluidity of similar commercial and third sector schemes within the market that have struggled to get strong buy-in from businesses and consumers.    

Food Business Commitment - Universal commitment and involvement from food businesses will be difficult to achieve:  

• cpmmercial and third sector schemes have struggled to achieve sustainable levels of business interest in similar schemes.  
• people with FHS represent a small percentage of the market.  Unlike other sub-populations, such as vegetarian or vegan, there is an increased risk associated with catering for people with FHS.  For food businesses, the economic benefit of an increased market may not offset the risk and additional costs of providing for this market.  Being legally compliant is different from actively targeting people with FHS.  

Complexity of Information - The information requirements of people with FHS are complex and individualised.  They need information about the allergens that are present in the food and to understand if the food business can manage cross-contact to an acceptable level based on their own personal FHS risk.  

2. Options for developing a Food Allergy Safety Scheme (FASS)  

Incorporate Allergens into the existing Food Hygiene Rating Scheme (FHRS)  

This could seem like an obvious and logical way to proceed but practically it would create significant challenges.  For example:   

• Enforcement of allergen legislation rests with both environmental health and trading standards teams.  The delivery of allergen interventions depends on local government arrangements which vary across England.  For example, in a two-tier district and county council setting, allergens are dealt with separately by each council’s food team.  A comprehensive allergen assessment under FHRS would require significant restructuring of local authority resources and place additional burdens on them.    
• Assessing food businesses on allergen management is a different process to assessing them for food hygiene.  Food hygiene practices, once embedded, tend to remain consistent whereas allergen management can fluctuate more rapidly when ingredients are substituted or recipes change.  Local authority officers have expressed concern about offering consumers assurances based on a single “moment in time” assessment for allergens.  During a series of workshops held with local authorities across England, Wales and Northern Ireland in autumn 2021 local authorities indicated that improvements in consumer confidence, choice and experience would be achieved more effectively and quickly through tailored training and support for food businesses.   
• Levels of allergen risk within a food business can also be very different from the hygiene risk.  For example, some food businesses that are low risk for hygiene, such as bakeries, might be high risk for allergens because of the risk of cross-contact (for example, because of allergens in flour).   
• A ‘0 to 5’ scale for allergen management would not provide clarity for consumers on what different scores mean for their safety.   
• The premise of FHRS is compliance with the law, and food businesses are not expected to do anything beyond basic compliance with the law to achieve a ‘5’ rating.  Many of the expectations that people with FHS have for an allergy scheme extend beyond current basic legal requirements (for example, our research shows that people with FHS check menu choices online and customer reviews to reassure themselves about how a business handles allergens).  As such, the inclusion of an allergen rating in FHRS may not provide them with the assurances and information they seek.   
• There are concerns that introducing allergens into FHRS may impact negatively on work to achieve mandation of the scheme in England.  FHRS is mandated in Wales and Northern Ireland and careful consideration would need to be given to how any changes were introduced to avoid undermining the existing scheme.   

FHRS offers an advantage over other options as the scheme is embedded with food businesses and has sufficient reach to be effective.    

However, this option would need a significant amount of time and resource to implement.  This would be disproportionate to the outcome of drawing out information (and one rating) on how a business adheres to their legal requirements on allergen information and allergen management and would not meet the needs of consumers identified in our research to date. 

FSA setting standards for third parties to administer schemes  

• allowing third parties to administer a range of commercial schemes would not be feasible, due to the lack of a commercial drive for FHS-focussed schemes and the confusion multiple individual schemes might create.  At present, there is no single scheme that covers all food hypersensitivities and has achieved national reach.  Endorsing one commercial or charity scheme would provide that scheme with an unfair competitive advantage.  
• as a comparison, the FSA successfully operates the Earned Recognition scheme for regulating primary food producers via FSA third party assurance schemes.  This approach is reliant on a strong commercial drive generated by food retailers who have sufficient purchasing power to stipulate assurance scheme membership as a condition of purchase.  
• people with FHS do not have the same level of purchasing power in the non-prepacked market, and represent a small and disparate effect, due of the range of different food hypersensitivities that exist and the variance in terms of severity.  For example, a food business may choose to focus on catering for those with coeliac disease but make less provision (for example, number of menu options) for those with nut allergies.  
• at a population level the numbers of people with FHS are relatively low and when sub-divided into specific food hypersensitivities their purchasing power is further reduced.  
• in the absence of commercial drive, the number of food businesses signing up to the scheme will be low.  A scheme being useful to consumers for informing choice about where to eat out is reliant on a critical mass of food businesses in each area joining the scheme.  A further problem is likely to be consumer awareness of a scheme – using FHRS as a parallel our research shows consumer awareness of the scheme was 20% a year after launch and took 9 years to rise to 54%.     

Conclusion  

Creating a food allergy safety scheme has two fundamental challenges:   

1. the information-based regulation model on which these schemes are premised is unlikely to be effective for FHS.  This has been demonstrated in the failure of other schemes to fully launch or expand, and the fluidity of the market.   
2. a scheme will not convey the complexity of information that people with FHS require to make safe and informed choices non-prepacked food.  

Investment of time, resource and capital may make incorporating allergens into FHRS possible.  Mandation would ensure that food businesses participated in some form of a food allergy safety scheme.  However, the fundamental challenge that a scheme is unlikely to achieve policy aims would remain.   

These challenges suggest that the scheme itself risks becoming the focus of attention rather than achieving the ultimate goal of helping people with FHS to manage risk.  

Recommendation  

The Food Allergy Safety Scheme (FASS) option is not progressed and the alternative option of a series of linked projects focusing on education and guidance for food businesses is developed and implemented.   

Workstream objective  

Understanding the information needs and preferences of people with FHS when purchasing non-prepacked food and the information needs of food businesses providing non-prepacked food to people with FHS. 

Approach to the workstream  

This annex synthesises our evidence gathering including:   

• Our latest research to improve our understanding of the provision of allergen information from consumer and food business perspectives4.   
• Other FSA research including the latest FSA Small and Micro Business tracker, the Food Sensitive Study5, ‘The preferences of those with food allergies or intolerances when eating out’ report, Allergen Management in Large Chains research (see summary at Annex F) and ‘The Food Industry’s Provision of Allergen Information to Consumers’ report.   
• Research from other government departments and information on international models.   

Key research findings and analysis of information needs    

For people with FHS, safety when purchasing non-prepacked food involves two elements: 

• The food does not contain the ingredient that the person is allergic to.   
• When the food is being prepared, it does not come into contact with the ingredient the person is allergic to.   

As such, to ensure that a person with FHS is provided with safe food requires information and action by the food business operator (FBO) and the person with FHS at multiple points in the non-prepacked food purchase journey (see Figure 1 below).  

The complexity of this journey for ‘non-prepacked’ food, comparative to purchasing ‘prepacked’ or ‘prepacked for direct sale’ (PPDS) food, combined with the diverse range of food business within the sector requires a ‘whole system’ approach rather than a focus on one or two elements in the journey.   

This annex explores each point in that journey and considers the current evidence on how businesses can improve safety, including consideration of different approaches to providing allergen information.    

Office for National Statistics (ONS) data shows there are in excess of 100,000 businesses within the sector, of which 77% are micro businesses with less than 9 employees, compared to large businesses with over 250 employees which represent less than 1% of the sector (to note this data looks at the number of food businesses and not the total number of food selling outlets, and one large business will operate multiple outlets).    

1. FBO needs information about the allergen requirements of a person with FHS.
2. Person with FHS needs information to know which foods they can eat (for example, absence of allergen).
3. FBO needs to accurately record allergen requirements when the food is ordered. 
4. FBO food preparation staff need information about allergen requirements conveyed to them.
5. FBO Food preparation staff need to action effective allergen cross-contact management procedures. 
6. Person with FHS needs information to know what steps 4 and 5 have occurred to be confident the food provided is allergen free. 

1. FBO needs information about the allergen requirements of a person with FHS  

The food business needs information about the allergen requirements of a person with FHS – without this information they are unable to provide appropriate information to people with FHS (Step 1) or manage allergen cross-contact risks whilst food is prepared (Step 5).   

Even if the food business is providing written allergen information there could be real time ingredient substitutions or recipe changes that need to be conveyed to the person with FHS.   

The ideal for people with FHS is that the food business will ask each customer about their allergen requirements (FHS Out of Home Allergen Information, 2022).  In practice, our research indicates that this might be difficult to achieve across the sector.  For example:   

• not all food businesses regularly encounter people with FHS and therefore the practice might be difficult to embed consistently (FHS Out of Home Allergen Information, 2022).  
• food businesses that offer a counter, rather than table service find the practice difficult to implement given the number of questions that they ask consumers (see Annex F).  
• food businesses are increasingly using digital ordering systems within their outlets that remove the interaction between the food business and the consumer at the point of food order (FHS Out of Home Allergen Information 2022).  Businesses would need to ensure they have some way of following up with a customer to initiate a discussion that could cover cross-contact risks.  

Whilst people with FHS do not necessarily want to ask about allergens and would prefer staff to ask them; our latest Food Sensitive study shows that most people with FHS (66% adults, 74% parents of children with FHS) feel comfortable asking staff for information.  This supports earlier findings in our  ‘Preferences of those with food allergies or intolerances when eating out’ research which indicate that 70% of those with FHS feel confident asking staff for allergen information, although this does mean a significant minority do not feel comfortable asking.  

Obligating restaurants to initiate a discussion with each customer about allergens on all occasions would be very difficult for local authorities to enforce as proof is reliant on the word of one individual against another.    

Food businesses need training and best practice guidance for eliciting allergen information from consumers in a variety of contexts, particularly digitally, so that this essential information about allergen requirements is conveyed to food preparation staff (Step 4) and allergens can be managed in the kitchen (Step 5). 

It is important to encourage people with FHS to make the food business aware of their allergen requirements when placing food orders and outline that they should not rely exclusively on any written information. 

2. Person with FHS needs information so that they know which foods they can eat  

People with FHS need information about allergens in food so that they can make informed choices about what to eat.  They have a strong preference for written information (FHS Out of Home Allergy Information 2022).  Our FHS Out of Home Allergy Information research shows that people with FHS perceive written information as reliable and do not consider the process behind keeping written information up to date or the impact of ingredient substitution on accuracy. 

Keeping information accurate and up to date 

Food businesses with frequently changing menus have expressed concerns about the feasibility of keeping written information up to date (Annex F and FHS Out of Home Allergy Information 2022) This finding is echoed in ‘The Food Industry’s Provision of Allergen Information to Consumers’ research with 30% of food businesses, rising to 51% amongst takeaways, facing challenges keeping written information up to date. This is potentially because changes to non-prepacked food can happen more frequently than with prepacked for direct sale (PPDS) foods as there is likely to be more fluidity around the preparation of non-prepacked food particularly for smaller businesses (for example, using up leftovers and ingredient substitutions).  

Additionally, the non-prepacked food business model is a continuous service model whereas PPDS food production occurs in advance in a more controlled production environment.  For example, if an ingredient is changed, it is more possible to amend the label in real time as it is added to the product or to pause production until the correct ingredient is available.  (It is also important to note that if ingredient substitution occurs at the last minute for product that is usually PPDS, and the label cannot be immediately amended, then the business still is able to sell the item as a non-prepacked product and provide the correct allergen information verbally.) 

In the non-prepacked food sector, making allergen labelling on menus and all ingredients listed within an allergen matrix a legal requirement could lead to unintended consequences, for example, incorrect allergen information being provided on a menu or matrix (as businesses find it difficult to manually update the information if there are regular ingredient changes and last minute substitutions), or a complex full ingredients matrix being misread. 

Most European countries adopt a similar approach to the UK for provision of allergen information in the non-prepacked food sector.  Ireland is a notable exception where details of the 14 regulated allergens must be provided in writing, although not necessarily on menus.  This requirement was introduced in 2014 with compliance audited in 2017.  The Targeted Audit of Allergen Information on Non-Prepacked Food indicated low levels of compliance by food businesses in terms of providing proper written allergen information to consumers. 88% of those businesses audited were not compliant with the requirement.  Of the 68% of businesses that did provide written allergen information, 76% of those provided inaccurate information. 

Preferences of people with FHS  

The FHS Out of Home Allergy Information research indicates that people with FHS strive for a “normal” eating out experience and favour information that gives them complete autonomy over their food choices with minimal intervention from food business staff.  

This indicates that people with FHS do not always consider that the absence of an ingredient in a dish does not necessarily remove the risk of cross-contact with allergens during the preparation and cooking process.  As such, they do not always realise the importance to their safety of the food business being aware of their allergen requirements.  Introducing full allergen labelling on menus, or a full ingredients list in an allergen matrix, in this cultural context risks reducing essential safety information about allergen requirements being conveyed to the food business.   

Whilst existing legislation is clear that food businesses must provide accurate information on the 14 regulated allergens, people with FHS and food businesses have expressed a desire for greater standardisation of written information and “best in class” models to provide clarity on what good looks like.    

The FHS Out of Home Allergy Information research indicates that the information preferences of people with FHS are for menus that are:  

• clear, easy to read and not overcrowded with too much detail.   
• use letters to denote the most common allergens as letters are easier to understand than symbols, for example, GF (gluten free), DF (dairy free) and NF (nut free).   
• focus on what the person with FHS can eat, not what they cannot eat, for example, “DF (dairy free)” rather than “contains milk”.  This makes it easy to quickly scan a printed or digital menu and find suitable dishes.   
• allow food businesses flexibility of design so that information is presented in a way that is in keeping with the style of the food business.   

This research also suggests that where information is not provided on a menu the preference is for alternative information, which is clearly presented and quick to navigate, and is provided before the decision-making process commences.  This avoids causing delays to their party due to having to sift through complicated allergen information.  The ideal situation is a digital menu that can be filtered by allergen. 

Different methods used to present information 

‘The Food Industry’s Provision of Allergen Information to Consumers’ research indicates that food businesses typically use a variety of different methods to provide allergen information to consumers (for example, verbally, “ask staff notices” and a separate allergen booklet or leaflet); with 95% using both written and verbal methods. This finding is echoed in the recent FHS Out of Home Allergy Information6 research and those food businesses that do not provide written allergen information indicate that this is feasible with appropriate support and guidance from the FSA for small businesses.  

• Our latest FHS Out of Home Allergy Information research indicated that food businesses provide allergen information in a variety of ways including: 39% allergen notices on menus, 25% separate allergen menus, 24% allergen matrixes, 19% an “ask staff sign or sticker, 17% labelling on printed menus (numbers, words, symbols), 17% labelling on menu boards, 24% ask consumers about dietary requirements. 

This suggests that training and guidance for food businesses is appropriate to ensure that they are equipped and confident to provide accurate allergen information that meets the needs and preferences of people with FHS.  This includes best practice recommendations and setting standards for written information in printed and digital formats, including guidelines about updating written information.   

3. FBO needs to accurately record allergen requirements when the food is ordered 

There needs to be a process in place to accurately record allergen requirements when the food is ordered so that this information can be conveyed to food preparation staff (Step 4).  

Suggestions in our most recent FHS Out of Home Allergy Information research include tick boxes for allergens on the order pads used by staff.  Consideration also needs to be given to capturing allergen information for food businesses that use digital ordering, for example QR codes at tables, online food ordering applications, websites or digital menu boards. 

4. FBO food preparation staff need information about allergen requirements conveyed to them  

The captured allergen requirements need to be conveyed to food preparation staff in the business either via a physical written order or digitally. 

The information needs to be presented in an obvious way that cannot be accidentally missed.  The digital system needs a ‘failsafe’, for example, food preparation staff cannot view the entire order until they have reviewed the allergen information and the information is then highlighted again next to the order of the person with FHS. 

5. FBO food preparation staff need to action effective allergen cross-contact management procedures  

When allergen information is received by food preparation staff they need to understand and action effective cross-contact management procedures.   

Recent workshops (carried out in October 2021) with local authorities across England, Wales and Northern Ireland indicate that food businesses understand how to manage bacteria but are far less confident, and need further guidance, to manage allergen cross-contact risks.  Problems observed by local authorities include:  

• cooking sesame prawn toast in a chip fryer rather than a separate fryer risking sesame and crustacean cross-contact with other foods
• picking nuts off the top of a dish, instead of preparing a nut-free dish from scratch
• overlooking how food is stored and not considering the risk of cross-contact. 

6.  Person with FHS needs information to know that steps 4 and 5 have occurred to be confident that the food provided is allergen free  

For a person with FHS the journey to receiving food that meets their allergen requirements has multiple stages which are outside the individual’s control and mistakes could occur through human error or technological failure.   

Our latest FHS Out of Home Allergy research indicates that people with FHS would like confirmation when the food is presented that their allergen requirements have been actioned.  Our earlier ‘Preferences of those with food allergies or intolerances when eating out’ research highlights that some people with FHS use a potentially dangerous practice of taste testing a small amount of food to check for allergens. 

Within the latest research there are various suggestions as to how this might be achieved that could work across a range of different types of non-prepacked business, for example, light-touch verbal confirmation when food is presented or visual confirmation such as flags in food and stickers on takeaway packaging.  

Confirmation that allergen requirements had been actioned would provide reassurance for the person with FHS.  The absence of this confirmation would act as a safety prompt for further communication with the food business to check if allergen requirements had been understood and actioned.   

Conclusions  

The findings from our research and evidence gathering highlight the need to improve the consistency of allergen information at key consumer touchpoints (throughout the food ordering and preparation process) and embed communication approaches that work effectively across different business models in the non-prepacked sector, including digital ordering processes.  The importance of ensuring that information is conveyed to food preparation staff so that the risks of cross-contact with allergens can be managed is also paramount to the safety of people with FHS.   

Providing written information and getting food businesses to ask about allergen requirements on its own is not enough to keep consumers safe when purchasing non-prepacked food.  

Recommendations  

The suggested approaches presented in this annex are incorporated into our recommended training and guidance projects for the non-prepacked sector, with guidance provided for each step in the food purchase journey.  This work will enable and equip food businesses to do the right thing across the non-prepacked sector and address emerging challenges that the shift towards digital ordering presents to the safety of people with FHS.  

Evidence from our ‘Food Industry’s Provision of Allergen Information to Consumers’ research indicates that only 49% of businesses have training on allergens. The FSA recognises it will need to work with FBOs, in particular SMEs, where the business model makes implementing such changes more challenging.  

Throughout the implementation of these recommended projects, we will carry out evaluation work to assess efficacy and determine if other approaches are required which can then be effectively targeted at points in the non-prepacked food purchase journey where food businesses have failed to embed change.   

We also recommend exploring strengthening enforcement capability for allergens through fixed penalty notices.  This would provide a strong financial incentive for food businesses to comply with existing legislation and any future legislative changes.   

Purpose of this summary 

This document contains a high-level summary of some of the key themes and useful findings extracted from the full report.  

As per the Privacy Policy for this project, the full report is not to be published.  During discussions with participants, it became clear that there was an interest in sharing some key findings that chains may find useful.  All participants have confirmed that they are happy for this extract to be shared between other participants and the FSA Board. 

Background 

The Foods Standards Agency (FSA) commissioned Ipsos MORI to explore large chain food businesses’ allergen management policies.  Large chain food businesses have been recognised as a group where good practice and innovative approaches to allergen management take place.  

This research aimed to explore how large restaurant chains in the UK cater for people with food hypersensitivity (food allergies, intolerances and coeliac disease).  This included understanding any changes or innovative approaches to allergen management that have been trialled or implemented in recent years that can inform allergen management guidance for the wider restaurant industry.  The research was designed to investigate the following questions: 

• What approach do large chains take to allergen management and what are the reasons behind this?  
• How do large chains present allergen information to consumers?  
• How do large chains manage allergens in the supply chain?  
• How do large chains train staff to deal with allergens?  
• How do large chains ensure standards and consistency of allergy management policy across multiple operating sites?  

Ipsos MORI conducted qualitative interviews with representatives from large chain food businesses.  This allowed researchers to explore the detail and nuance of chains’ policies, procedures, challenges and any recent changes.  A total of thirteen qualitative interviews were conducted with fieldwork taking place between 15th October and 15th November 2021.  Each interview lasted up to 45 minutes and followed a discussion guide. 

Reading this summary 

Throughout this summary we have referred to the individuals who opted in to participate in our research as “interviewees”.  We have referred to the food businesses that they represent as “chains”.  

Qualitative research is designed to be exploratory and provide insight into people’s perceptions, feelings, and behaviours.  The findings are therefore not intended to be representative of the views of all large restaurant chains, but rather highlight and indicate key themes expressed by those we spoke to.  

Key themes 

Involving staff in the development of allergen policies can help to generate staff buy-in and ensure approaches are practical for use in restaurants.  Chains maintain standards through training programmes, both internal and external audits, mystery shopping, and accreditation schemes.  

Engaging customers in a conversation about their allergy is a critical part of chains’ allergen management to enable them to implement their allergen policy, for example the way foods are prepared in the kitchen.  However, approaches to doing this differ:  

• proactively asking every customer if they have an allergy.  This is often used by chains that offer table service but relies on staff consistently asking all customers.  
• including prompts on menus, posters and apps/online.  This places the responsibility on the customer for asking about allergens. 

Chains using counter service tended not to ask each customer about their allergies given the number of questions already being asked by staff at the till. 

Most chains do not include allergen information on their main menu as this could discourage customers from disclosing an allergy to staff.  This is because the customer may feel they have all of the allergen information they need from the menu and can therefore eat safely without discussing their allergy.  This creates significant risk, as if staff are not aware they will not know to follow the relevant allergen procedures.  This could lead to an allergen incident due to cross-contamination when preparing and serving the food.  It can also make it more difficult to keep allergy information on menus up to date if a recipe changes or ingredients need to be replaced.  

In some cases, while the menu does not specify where allergens are present, it will indicate when a product is new or where an existing product has a new recipe.  This is designed to encourage regular customers to have a conversation about their allergy with staff.  

Supply chain complexity can make it more challenging to provide full ingredient lists to consumers.  Chains described how integrated digital systems can help to manage this process.  

Recent upheavals in supply chains, the Covid-19 pandemic and the introduction of Natasha’s Law have led chains to review and update their allergen management policies.  Notably, this has accelerated a shift towards digital systems to provide allergen information to consumers without the need to handle physical documents.  Digital systems can also provide real-time updates on ingredients, meaning changes in the supply chain can be immediately communicated to all sites.  

Most chains do not manage allergen orders via third party delivery services.  Instead, they prompt online customers with allergies to place a click-and-collect order with the restaurant directly. 

Background

Owen Carey died in 2017 after eating chicken marinated in buttermilk whilst having lunch at a branch of Byron Burger during a celebration of his eighteenth birthday. Owen had multiple allergies, including to dairy (e.g., buttermilk), and relayed this information to the server. At the subsequent inquest, the coroner found that there 'must have been human error' by a member of Byron serving staff at the point of ordering and that Owen was not provided with the correct information about the ingredients used in the meal he ordered.

Following Owen's death, the Carey family have campaigned for better allergen information in restaurants, and for a number of other changes that would improve information provided to people with a food hypersensitivity, and the way in which deaths from food-related anaphylaxis are recorded.  Specifically, they have called for the allergens in a restaurant’s meals to be stated on the face of the menu, be that in paper or electronic form. 

The FSA supports the objectives of the Owen's Law campaign to improve the provision of information about allergies when eating out, and we are grateful to the Carey family for their work to raise awareness of the risks and promote best practice so that future avoidable deaths can be prevented.

The FSA's role

The primary responsibility for investigating potential breaches of food law that may have caused or contributed to a death lies with local authorities. The FSA is responsible for setting the overall framework in which local authorities operate. When there is an inquest into a death from food-related anaphylaxis, the FSA, alongside local authorities, may be called on to provide evidence about the law and how it is implemented and enforced, and/or to respond to recommendations from the Coroner about how future deaths can be prevented.

The FSA is responsible for food safety labelling, which includes labelling about the presence of allergens in food.

The FSA's goal is to prevent avoidable deaths from foodborne disease and food-related anaphylaxis. We strive to learn the lessons from deaths that sadly do occur and to hear from those affected about the circumstances so that we can take this into account in policy making. FSA officials may meet with bereaved families directly, and/or we may receive information through the various charities that support people with food hypersensitivity.

The FSA Chief Executive and senior officials have met the Carey family on a number of occasions to discuss the circumstances of Owen's death and how future deaths can be prevented.

The FSA's response to Owen's death

Following the inquest into Owen's death, the Coroner's report made recommendations that fell under the respective remits of the FSA, Defra and DHSC. A joint response was published in January 2020.

Since the inquest, and meeting the commitments we gave in our response, the FSA has:

• Updated our allergen management guidance and training for business;
• Launched two new campaigns targeted at young people to encourage them to ask about allergens when eating out;
• Trialled a reporting tool for people with FHS to report 'near miss' reactions directly to the FSA;
• Conducted further research into the information needs of people with FHS when eating out, and the most appropriate and effective methods for consumers and businesses to exchange information so that risks can be effectively identified and managed;
• Held three annual Food Hypersensitivity Symposia bringing together people with FHS, food businesses, academics, health service professionals, representative organisations and policy makers to exchange best practice, discuss solutions and hear about the latest research and evidence.

A planned FSA campaign targeted at food businesses to raise awareness about business responsibilities for providing accurate allergen information did not go ahead due to the Covid pandemic. Food businesses will be a key focus for the next phase of the FHS programme.

The Owen's Law campaign

Following the death of Owen Carey in 2017, the Carey family have been campaigning for changes to legislation. The campaign proposals within the FSA’s policy remit are:

• Restaurants required by law to label the fourteen regulated allergens on their menus with standardised symbols, numbers or words;
• Restaurants required by law to provide a full breakdown of ingredients for each dish in an allergen matrix.
• Restaurants required by law to ask each customer about allergen requirements on all occasions. The duty manager to be obligated to directly supervise this process where allergens are present, with it being an offence if they fail to do so.

The FSA agrees that greater standardisation of written information provided in restaurants and non-prepacked environments would be helpful for businesses and consumers. The FSA also agrees that verbal communication between customers and restaurant staff is vital for the exchange of information that helps customers and businesses understand and manage the risk. We support the campaign's call for better training for restaurant staff so they understand their responsibilities in relation to allergen management.

Our conclusions about how these policy goals can be taken forward are discussed in the paper.

Between August 2021 and March 2022 work took place to investigate the feasibility and design of a food allergic reaction reporting mechanism (FARRM) to enable consumers with a FHS to report incidences of allergic reactions. We wanted to understand whether consumers would be willing to report reactions and near-misses for the purposes of informing policy making and if so, what information they would be willing to give. 

The work also sought to understand the feasible number of questions, appropriate question wording and, through a FARRM Proof of Concept (PoC), gather consumer feedback.  

Promotion of the PoC focused on engagement with key charity and consumer organisations, and targeted social media activity.  The following charities and organisations provided front doors (or sign-posts) to the tools on their website to help raise awareness and support their members to report a FHS occurrence or a near miss: 

• Natasha Allergy Research Foundation 
• Anaphylaxis Campaign 
• Coeliac UK 
• Allergy Action 
• The Allergy Team 
• Allergy UK 

During the 4-month testing period, 498 reports were received (371 reactions and 127 near-misses).   

While the work demonstrated that consumers were willing to use the tool and report their reactions and near-misses to FSA for the purpose of informing policy development it did highlight a number of potential barriers to the introduction of a FARRM tool:  

Achieving and maintaining consumer awareness 

The communications and media campaign for the PoC was effective, but its impact was temporary – while there were spikes in reports following promotion on social media channels – engagement did drop over 4-month period.  

A review of the campaign suggests that solely relying on online promotion, particularly using social media, does not effectively reach those who do not spend considerable time online, or do not engage with FSA or FHS focused accounts.  

The work concluded that achieving and maintaining the high levels of awareness for FARRM would require significant and ongoing investment of resources.  

Data validity 

The work found that the self-reporting nature of the tool would reduce the “value” of the data that FARRM would provide as: 

A count of reactions without a count of the total population of people with FHS may be of limited value. 

There is a risk of an unquantifiable self-reporting bias. 

The data collected would need to cover a relatively long time-period to establish a baseline and allow the effect of policy changes to become apparent.  

Consumer motivations and expectations 

Usability testing and feedback from the PoC suggests that while consumers are motivated to report reactions, strategies for sustaining this motivation would need to be explored as there is no immediate tangible outcome or behavioural reward for consumers who use the tool that would reinforce reporting behaviour.  

Conclusions 

The user engagement work delivered as part of the PoC provided valuable insight into consumer expectations which has applications for the wider work of the FSA.  The use of user personas proved to be effective way to segment users and this work will be carried forward.  We plan to review the personas on a regular basis. 
 
The design of the questionnaire was successful with users reporting that the questions were clear, and the form was about the right length. 

The work with the charities and organisations to promote the FARRM through social media and links on their website was effective and we are considering how it could be applied to FSA work on food hypersensitive in the future. 
 
The work concluded that the barriers highlighted above mean that FARRM does not   offer good value for money and alternative methods of collecting data on the nature and number of FHS reactions and near misses should be explored.  

Next steps 

The outputs of the work will be used by the policy team to consider alternative approaches to collecting the required information including assessing the potential for a regular FHS survey to provide a more effective way to capture information on the nature and extent of FHS reactions.