Celia Marsh
PFD Report
All Responded
Ref: 2022-0379
All 8 responses received
· Deadline: 16 Jan 2023
Sent To
Response Status
Responses
8 of 8
56-Day Deadline
16 Jan 2023
All responses received
About PFD responses
Organisations named in PFD reports must respond within 56 days explaining what actions they are taking.
Source: Courts and Tribunals Judiciary
Coroner’s Concerns
I indicated that my report would cover a number of areas to highlight the suggestions made by and others during the inquest. I explained that a report is not to dictate what that action should be however in this case I considered that it was right that I should pass on to those organisations suggestions made by the experts and indeed others who have assisted me in my investigation, it is of course a matter for you what if any steps you take.
The MATTERS OF CONCERN were as follows:
Concerns were raised in relation to the immediate investigation into a suspected death from anaphylaxis, that the evidence obtained at this time, with the right approach, can be invaluable to preventing deaths, but that to achieve this changes are required. This would need changes in the death investigation process and the wider investigation which would need assistance from the Food Standards Agency (FSA).
I was made aware that there needs to be better education both to doctors and to patients in risk groups to prevent future deaths
I was also advised that whereas the FSA would be required to assist with the above areas it could also assist in relation to the current practices of food labelling.
Firstly in relation to Pathology, I am told that the current guidance is 10 years old, the suggestion is for this to be revisited and specifically: If bloods are taken at hospital that they are not destroyed in a suspected case but retained for testing That an early blood sample is taken after death and stored for late analysis That the possibility that a death is due to anaphylaxis is raised with the Senior Coroner for the area where the death occurred at the earliest opportunity
That an early blood sample is taken after death The post mortem examination should be prioritised. At the post mortem examination: that stomach contents are taken and frozen to enable testing and that tissue samples are taken
A standard protocol should be available to ensure appropriate samples are taken at the correct time to assist later investigation.
In relation to doctors/patients: To highlight, through public awareness and to the medical profession, that while the majority of food-allergic individuals are at very low risk of fatal reactions, a small subset of food-allergic individuals may be at significantly higher risk. These persons must be given appropriate advice as to the dangers of inadvertent exposure, since there may be no detectable safe level of allergen that can be present in a product for this group. To be aware that avoidance of foods in adults does not improve eczema and may result in more severe allergy to the food avoided particularly to cow’s milk but tolerance can be maintained by continued regular exposure.
In relation to the FSA, the UK Health Security Agency and the Department of Health and Social Care: To establish a robust system of capturing and recording cases of anaphylaxis, and specifically, fatal and near-fatal anaphylaxis, to provide an early warning of the risk posed to allergic individual by products with undeclared allergen content. Such a system could involve mandatory reporting of anaphylaxis presenting to hospitals, analogous to the current system used for notifiable diseases (including some food-borne illnesses) whereby registered medical practitioners have a statutory duty to notify the ‘proper officer’ at their local council or local health protection team of suspected cases of certain infectious diseases. An example of such a reporting system for anaphylaxis already exists in the state of Victoria in Australia, and also allows for rapid alerts of serious cases to public health authorities to expedite investigation and evaluate the public health risk.
In relation to the FSA, the British Retail Consortium, Food and Drink Federation and British Hospitality: The wording used on food products, and the public’s understanding of these phrases in terms of implying the absence of a particular allergen, can be potentially misleading. Examples include: “free-from” and “vegan”. Foods labelled in this way must be free from that allergen, and there should be a robust system to confirm the absence of the relevant allergen in all ingredients and during production when making such a claim. With respect to those with the most severe food allergies, it may be necessary in the interim to clarify that foods labelled “free-from [X allergen]” may not be safe to consume.
In relation to the FSA: A hotline to the FSA to provide guidance in fatal cases due to suspected anaphylaxis, although a mandatory reporting system (suggested above) would address this need. Nationally recognised best practice and technical advice to assist those investigating such cases;
The MATTERS OF CONCERN were as follows:
Concerns were raised in relation to the immediate investigation into a suspected death from anaphylaxis, that the evidence obtained at this time, with the right approach, can be invaluable to preventing deaths, but that to achieve this changes are required. This would need changes in the death investigation process and the wider investigation which would need assistance from the Food Standards Agency (FSA).
I was made aware that there needs to be better education both to doctors and to patients in risk groups to prevent future deaths
I was also advised that whereas the FSA would be required to assist with the above areas it could also assist in relation to the current practices of food labelling.
Firstly in relation to Pathology, I am told that the current guidance is 10 years old, the suggestion is for this to be revisited and specifically: If bloods are taken at hospital that they are not destroyed in a suspected case but retained for testing That an early blood sample is taken after death and stored for late analysis That the possibility that a death is due to anaphylaxis is raised with the Senior Coroner for the area where the death occurred at the earliest opportunity
That an early blood sample is taken after death The post mortem examination should be prioritised. At the post mortem examination: that stomach contents are taken and frozen to enable testing and that tissue samples are taken
A standard protocol should be available to ensure appropriate samples are taken at the correct time to assist later investigation.
In relation to doctors/patients: To highlight, through public awareness and to the medical profession, that while the majority of food-allergic individuals are at very low risk of fatal reactions, a small subset of food-allergic individuals may be at significantly higher risk. These persons must be given appropriate advice as to the dangers of inadvertent exposure, since there may be no detectable safe level of allergen that can be present in a product for this group. To be aware that avoidance of foods in adults does not improve eczema and may result in more severe allergy to the food avoided particularly to cow’s milk but tolerance can be maintained by continued regular exposure.
In relation to the FSA, the UK Health Security Agency and the Department of Health and Social Care: To establish a robust system of capturing and recording cases of anaphylaxis, and specifically, fatal and near-fatal anaphylaxis, to provide an early warning of the risk posed to allergic individual by products with undeclared allergen content. Such a system could involve mandatory reporting of anaphylaxis presenting to hospitals, analogous to the current system used for notifiable diseases (including some food-borne illnesses) whereby registered medical practitioners have a statutory duty to notify the ‘proper officer’ at their local council or local health protection team of suspected cases of certain infectious diseases. An example of such a reporting system for anaphylaxis already exists in the state of Victoria in Australia, and also allows for rapid alerts of serious cases to public health authorities to expedite investigation and evaluate the public health risk.
In relation to the FSA, the British Retail Consortium, Food and Drink Federation and British Hospitality: The wording used on food products, and the public’s understanding of these phrases in terms of implying the absence of a particular allergen, can be potentially misleading. Examples include: “free-from” and “vegan”. Foods labelled in this way must be free from that allergen, and there should be a robust system to confirm the absence of the relevant allergen in all ingredients and during production when making such a claim. With respect to those with the most severe food allergies, it may be necessary in the interim to clarify that foods labelled “free-from [X allergen]” may not be safe to consume.
In relation to the FSA: A hotline to the FSA to provide guidance in fatal cases due to suspected anaphylaxis, although a mandatory reporting system (suggested above) would address this need. Nationally recognised best practice and technical advice to assist those investigating such cases;
Responses
Response received
View full response
Dear M. E. Voisin Re: Death of Celia Lindsey Marsh Thank you for your communications received on 25 November 2022 addressed to the UK Health Security Agency (UKHSA). Whilst we understand the seriousness of the failings leading to the death of Celia Mars.h responsibility for establishing systems such as those referred to by the Coroner sit outside of the remit of UKHSA. The Food Standards Agency (FSA) and the Health and Safety Executive (HSE) hold responsibility for food policy related matters. When Public Health England (PHE) became UKHSA the responsibility for nutrition and health campaigns transferred to the Department of Health & Social Care (DHSC). Please do not hesitate to contact UKHSA if we can be of any further assistance in this matter.
Response received
View full response
Dear Ms. Voisin, We are writing to you regarding the regulation 28 report {dated 21 November 2022) to prevent future deaths, and the concerns as set out in section 5 of the report addressed to a number of industry bodies including UKHospitality {referred to in the report as British Hospitality). UKHospitality represents over 740 companies operating around 100,000 venues across the breadth of hospitality within England, Scotland, and Wales. Our membership covers the full scope of hospitality, from small independents to large multi-national sites operating across the accommodation, restaurant, pub, events, and leisure sectors One element of operation that is common across virtually all of our membership is the provision of food to the public. Given the importance of food issues, both in terms of safety and nutrition, UKHospitality has two specific policy groups composed of operational experts from within member companies. These groups provide expert insight and information on how the UK hospitality sector works in terms of food process and how we interact with our customers on the wide range of issues that are encountered daily. Regarding allergens and hypersensitivity, the hospitality sector is working collaboratively across companies, suppliers, online delivery platforms, the Food Standards Agency, customer representative bodies and charities to ensure we develop the most effective and workable solutions when it comes to food safety across the wider out of home sector. This includes close collaboration with the Food Standards Agency hypersensitivity strategy with a focus on smaller businesses and raising awareness around the current law and responsibilities with regard to allergens. Prior to the publication of your report and the specific recommendations for UKHospitality, we released in early November 2022 an updated version of our Industry Catering Guide to UKHospitalily 6th Floor 10 Bloomsbury Way London WC1A 2SL Telephone: 020 7404 7744 I info@ukhospitality.org.uk I www.ukhospitality.org.uk
UKIHI UKHOSPiTAUTY Good Hygiene Practice {linked in text). The guide, developed in partnership with the Food Standards Agency and Food Standards Scotland, sets out the legal obligations for caterers and the practical requirements to comply with food hygiene law. The guide also offers advice to operators on good practice, which although ls not a legal requirement, is likely to contribute to the overall achievement of food safety and customer satisfaction. Whilst making statements regarding 'free from' can be a useful tool in helping our customers make informed choices when dining out of home, given the nature of catering companies, ensuring no cross contact occurs in kitchens can often be a complex task and therefore our understanding is that the majority do not make such claims. Instead, in many catering settings, there is an opportunity for a conversation between customers and the server to explain the risk of cross contact, which Is often an important step in helping customers make informed choices. However, our updated Industry Guide includes a section reminding businesses of their duty to ensure that no cross contact is possible when making 'free from' claims. It is clear to see that the market for vegan dishes has grown substantially over the last few years. Many businesses across the UK offer a number ofvegan options on menus, with vegan restaurants continuing to grow In popularity. When making specific claims around vegan dishes, whilst it is Important to provide customers with as accurate information as possible, statements regarding vegan food Is not a hypersensitivity issue. However, we recognise the importance of the issues set out in your report and commit to carrying out a consultation with members in the aforementioned expert groups on managing the risk of vegan dishes for people with hypersensitivity, and reflecting any recommendations in future updates to the Industry Guidance. Attached alongside this letter is a hard copy of the current Industry Guide for reference, including the sections on 'free from' and allergens as highlighted above, and we would be more than happy to have future discussions on any of the topics mentioned.
UKIHI UKHOSPiTAUTY Good Hygiene Practice {linked in text). The guide, developed in partnership with the Food Standards Agency and Food Standards Scotland, sets out the legal obligations for caterers and the practical requirements to comply with food hygiene law. The guide also offers advice to operators on good practice, which although ls not a legal requirement, is likely to contribute to the overall achievement of food safety and customer satisfaction. Whilst making statements regarding 'free from' can be a useful tool in helping our customers make informed choices when dining out of home, given the nature of catering companies, ensuring no cross contact occurs in kitchens can often be a complex task and therefore our understanding is that the majority do not make such claims. Instead, in many catering settings, there is an opportunity for a conversation between customers and the server to explain the risk of cross contact, which Is often an important step in helping customers make informed choices. However, our updated Industry Guide includes a section reminding businesses of their duty to ensure that no cross contact is possible when making 'free from' claims. It is clear to see that the market for vegan dishes has grown substantially over the last few years. Many businesses across the UK offer a number ofvegan options on menus, with vegan restaurants continuing to grow In popularity. When making specific claims around vegan dishes, whilst it is Important to provide customers with as accurate information as possible, statements regarding vegan food Is not a hypersensitivity issue. However, we recognise the importance of the issues set out in your report and commit to carrying out a consultation with members in the aforementioned expert groups on managing the risk of vegan dishes for people with hypersensitivity, and reflecting any recommendations in future updates to the Industry Guidance. Attached alongside this letter is a hard copy of the current Industry Guide for reference, including the sections on 'free from' and allergens as highlighted above, and we would be more than happy to have future discussions on any of the topics mentioned.
Response received
View full response
Dear Ms Voisin, REGULATION 28 REPORT TO PREVENT FUTURE DEATHS-CELIA MARSH: RESPONSE BY THE FOOD STANDARDS AGENCY Thank you for sending me the Regulation 28 report of the Coroners (Investigations) Regulations 2013 following the inquest into the tragic death of Celia Marsh (deceased 27 December 2017) from a severe anaphylactic reaction. I would like to extend my deepest sympathies and those of the Food Standards Agency (FSA) to the family of Mrs Marsh. We have considered the matters of concern you have raised, and the actions which you have recommended should be taken and would like to offer the following response. Whilst considering our response, we have made contact with other recipients of your report to discuss the relevant recommendations. The investigation process In introducing your detailed recommendations you highlighted broader concerns " ...in relation to the immediate investigation into a suspected death from anaphylaxis, that the evidence obtained at this time, with the right approach, can be invaluable to preventing deaths, but that to achieve this changes are required" and noted that "this would need changes in the death investigation process and the wider investigation which would need assistance from the Food Standards Agency (FSA)". Floors 6 & 7, Clive House 70 Petty France, London SW1H 9EX Email: food.gov.uk/ratings ForlnfOITnalion on the FSA's Privacy Polley, did<~ F0< further infoimalion on how we handle your1>9rsonal data please cllck!J!m or enter. https:1/www fogd.goy.Ul<labout-us/plivaC'f:fJQtice-pdvate-offioe-c0<resooodence inloyour web browser-.
Before addressing your detailed recommendations, I thought it might be useful to set out our role as the Central Competent Authority (CCA), when notified of incidents where there has been serious illness and/or fatalities linked to food. Our responsibilities are to:
• support the enforcing authority with the necessary policy and expert advice that will result in unsafe food being removed from the market.
• notify and liaise with international Food Safety Officials if there is distribution outside of the UK. In the UK, authorised food officers within local authorities have responsibility for official controls in relation to food law enforcement and therefore have the responsibility and powers for investigating in such instances. The FSA is responsible for issuing and maintaining the Food Law Code of Practice and associated Practice Guidance, which set out our expectations for how official controls in relation to food, including incident investigations, should be delivered by local authorities in line with their responsibilities under food law. The actions and nature of the FSA's support to local authority investigations depends on when we are notified of the incident. In the main, local authorities are required to categorise food hazards, and notify the FSA by the quickest possible means if an incident is either a widespread, or a localised but serious hazard. At the time of this incident, the Food Law Code of Practice, England , 2017 was in place, which required notification to the FSA for 'allergi incidents or if 'any deaths associated with the incident,' occurred. These requirements were strengthened in a review of the practice that led to the March 2021 version. This provides more details on requirements to notify the FSA as a result of an incident linked to an allergy. It now requires that the FSA is notified if there are 'undeclared allergens, a serious anaphylaxis reaction requiring medical intervention as a result of allergens in food, hospitalisation, or death as a result of allergens in food'. The FSA requests timely notification in the initial stages of the incident to allow for appropriate assessment and provision of food safety advice from the FSA, to inform food safety action to be swiftly taken by the food business, on advice and instruction from the competent authority, ordinarily the Local Authority, who is the enforcing authority. It is also not uncommon for the FSA to be notified of an incident by the coroner, at the inquest stage or to learn of deaths as a result of exposure to food from the press on conclusion of an inquest. In such an instance, the FSA's role is limited to providing the necessary policy advice, access to subject matter experts, international communications through the International Food Safety Authorities Network (INFOSAN). As part of routine improvements and drive for efficiency, the FSA is currently producing an internal standard operating procedure for dealing with serious illness and fatality incidents, which includes incidents of anaphylaxis. Our aim is to ensure we take a robust and consistent approach to such occurrences. This procedure will include detail of how we can make local authorities aware of such occurrences at the earliest time possible (if the FSA is notified through other means in the first instance). Additionally, the FSA is developing training for local authorities on incident Floors 6 & 7, Clive House 70 Pe France, London SW1 H 9EX Email: food.gov.uk/ratings For inlocmation on Ole FSA's Privacy Poliey, click~. For flJ1111er lnfonttatlon on how we handle yoU< personal dala please dld(J:lfIB or enter. h\Jps-//wWw food.gov 1!!<fa9pc1.ustptjvacy.09Jice-gjv;,10-0(Jjce-oorrespongence into ~our web browser.
management, including detection, reporting and incident response to compliment the Food Law Code of Practice, and the Practice Guidance, that is planned for roll out in 2023/24. You have also noted that The FSA could assist with current practices offood labelling". The FSA is responsible for food safety labelling in England, Wales and Northern Ireland and I will discuss this in more detail later in this response. Your concerns regarding pathology have been noted, however this is not an area where the FSA has policy responsibility. I can see that your report has been directed to the Department for Health and Social Care (DHSC} and the Royal College of Pathologists who may be able to offer a response to these concerns. We are however, open to assisting other government departments where we can. Reporting and recording You recommended establishing"... a robust system of capturing and recording cases of anaphylaxis, and specifically, fatal and near-fatal anaphylaxis, to provide an early warning of the risk posed to allergic individual by products with undeclared allergen content" and noted that such a system could involve mandatory reporting and indicated how this might work. The FSA is responsible for food safety labelling and food allergy policy in England, Wales and Northern Ireland (Food Standards Scotland have this responsibility in Scotland). When a food business considers or has reason to believe that a food it has placed on the market is injurious to health, they are required to notify competent authorities such as a local authority who are in turn required to notify the FSA of serious or widespread incidents (or notify the FSA directly where we are the competent authority, e.g. food businesses approved by the FSA). There are, however, circumstances where no, or no timely, notification is provided. In these cases, a mechanism by which the FSA is made aware of cases of anaphylaxis (fatal or near fatal) would be very helpful. You have suggested a "mandatory reporting of anaphylaxis presenting to hospitals' similar to the system in place for notifiable diseases. The FSA would not be able to introduce such as a system as it would fall within the remit of DHSC. I would however, like to make you aware of the following: The FSA-funded NHS Data projectl was established to monitor trends in the occurrence of severe, food induced allergic reactions. This work includes the establishment of a UK Anaphylaxis Registry to collect data relating allergic reactions to both food and non-food triggers. While the Registry is not aimed at aiding the investigation of incidents, the questionnaire completed by patients when reporting reactions to the Registry is being updated to includes details on how to contact their local authority's food safety team to report an incident. 1 www.food.gov .uk/research/food-allergy-and-intolerance-research/using-nhs-data-to-monitor-trends-in-the-occurrence- of-severe-food-induced-allergic-reactions Floors 6 & 7, Clive Hollsa 70Pe Email: food'.gov.uk/ratings For inrom1alloo on the FSA's Privacy Policy, dick~. For lurlher information 011 hOIY we hand!& your personal dala please di<:kJJ§I§or enter: bllllS?!l'/WW food.qov.uk/ooout-us1p1ivacy•notice-prival,Hlflirn-cormspondern:e into your web browser.
Additionally In 2021, the FSA provided one-off funding to enable the UK Fatal Anaphylaxis Register (UKFAR) to be updated and maintained. The UKFAR, overseen by the British Society for Allergy and Clinical Immunology, is an active register of deaths from anaphylactic reactions, including food allergies which provides a long-term source of data to improve our understanding of the causes of anaphylaxis related fatalities. This work will help the FSA in its work to reduce numbers of food-related anaphylactic reactions. Wording used on products You raised concern that the "publics understanding of. .. " phrases such as "free from and "vegan" " ... in terms of implying the absence of a particular allergen, can be potentially misleading". You also stated that hFoods labelled in this way must be free from that allergen, and there should be a robust system to confirm the absence of the relevant allergen in all ingredients and during production when making such a claim. " You also suggested that as an interim measure, it may be necessary to clarify that foods with such claims may not be safe for those with the most severe food allergies. 'Free-from' and 'vegan' labelling have different purposes - a "free-from" allergen claim is an absolute claim and should only be used following a rigorous assessment of the ingredients, process and environment. Vegan labelling is not intended to be food safety labelling and there is currently no legal definition of the term "vegan"; vegan ism is a lifestyle choice based on a range of factors, including ethical, environmental, and nutritional choice. While vegan food should not contain animal products the Vegan Society advise that their Vegan Trademark can be used on food carrying a precautionary allergen label (a voluntary statement such as "may contain" to communicate the risk of the unintentional presence of an allergen in a food) for animal products provided that the labelling decision is based on a thorough risk assessment of cross-contamination . There is no specific UK legislation covering "free-from" (with the exception of "gluten-free) or "vegann claims. Any such claims are therefore regulated in accordance with the provisions of General Food Law which provides that voluntary labelling information shall not mislead the consumer or be ambiguous or confusing to the consumer. For any free-from claim to be considered not misleading, it would need to be an analytical zero (where the allergen concerned cannot be detected using the best and most appropriate method of detection). There is information on this subject on our website. There is also FSA endorsed guidance from the Food and Drink Federation (FDF) regarding the use of vegan and free from claims on food. The FDF promotes this guidance regularly and the FSA also signposts businesses to it for best practice. We are in the process of updating our allergen technical guidance to say that precautionary allergen statements should not be used in combination with a 'free from' statement for the same allergen. This work is ongoing and will be put out for further consultation shortly. Floors 6 & 7, Clive House 70Pe ~ Email--- food.gov.uk/rati ngs For intcrmation " " \'le FSA's Prtvacy Policy, click~ For rurthat information on hoW wa handle yoUf personal data p!ease cltd<. here or enter: hUps:IN1Ww.lood.qov.uk/aboul-us/pfivacy,oo!ice 4privafe·office-coJrnsportrl611ce into your web browser.
We will consider how best to promote the current guidance to businesses producing foods with these claims to encourage best practice more widely and continue to consider it alongside our work on precautionary allergen labelling. Additionally, to improve our understanding of consumer perceptions in these areas we are considering carrying out some behavioural research looking at vegan foods with the prospect of an educational campaign around vegan food not always being suitable for those with food hypersensitivities (those with a food allergy, intolerance or coeliac disease). Investigation hotline and best practice You recommended a "hotline to the FSA to provide guidance in fatal cases due to suspected anaphylaxis" and "nationally recognised best practice and technical advice to assist those investigating such cases. As mentioned above, the responsibility and power for such investigations does not sit with the FSA, therefore we would not be best placed to provide such a hotline. The FSA Food Law Code of Practice for local authorities includes guidance on contacting the FSA at the earliest opportunity where affected (potential) hazardous food is distributed beyond the authority's boundaries and/or where the hazard is serious, within the local authorities boundaries. A direct phone line and 24/7 365 days per year email address is in place at the food incidents teams at the FSA to receive these notifications. The Food Law Code of Practice also confirms that cross borough issues require agreement for one authority to take a lead to investigate. The FSA provide support and communications through food alerts etc. The FSA's commitment to improve the quality of life for people with a food hypersensitivity Reducing harm from food hypersensitivity is a fundamental part of the FSA's remit and our work in this area aims to improve the quality of life for people living with food hypersensitivity and support them to make safe, informed food choices to effectively manage risk. Since we published our new FSA Strategy (2022 to 2027) and workplan last year, the FSA is facing additional pressures, including significant new areas of work which in order to deliver has meant making some difficult decisions in some areas of our proposed programme. In addition to our core activities on food hypersensitivity we will ensure that the review of Retained EU Law retains current protections for people with a food hypersensitivity. In our wider food hypersensitivity programme we will focus on a smaller subset of priorities in three key areas:
• Precautionary Allergen Labelling (PAL) will be the priority amongst the three, focusing on improving the way PAL is applied by industry, and its effectiveness as a consumer information tool. Floors 6 & 7, Clive House 70Pe~ Email- food.gov.uk/ratings F°'information on lhe FSA's Ptillacy Policy, click tlfl!a. F°' fu<lher lnforrnolion or, how we handle your personal data please click ~ orM ter. h"ps·//\Y)WJ.food.9ov.uk/abo1jlj1s~1;Y-QOlice-prill>lle-offioe.co«espol\'Jence Into your web browser. J
• improving the provision of information for consumers in the non-prepacked sector (out of home), with a focus on the accuracy of information.
• enabling a step-change in the knowledge, skills and food safety culture of staff in the 'non-prepacked' sector through training. Key to the success of this work is ensuring food businesses, consumer groups, enforcement bodies and other government departments work together on this important issue and the FSA will continue its role as a convener to ensure that this happens. I would once again like to extend the FSA's deepest condolences to the family of Celia Marsh and hope that the work we are doing will help to prevent future occurrences of incidents like this.
Before addressing your detailed recommendations, I thought it might be useful to set out our role as the Central Competent Authority (CCA), when notified of incidents where there has been serious illness and/or fatalities linked to food. Our responsibilities are to:
• support the enforcing authority with the necessary policy and expert advice that will result in unsafe food being removed from the market.
• notify and liaise with international Food Safety Officials if there is distribution outside of the UK. In the UK, authorised food officers within local authorities have responsibility for official controls in relation to food law enforcement and therefore have the responsibility and powers for investigating in such instances. The FSA is responsible for issuing and maintaining the Food Law Code of Practice and associated Practice Guidance, which set out our expectations for how official controls in relation to food, including incident investigations, should be delivered by local authorities in line with their responsibilities under food law. The actions and nature of the FSA's support to local authority investigations depends on when we are notified of the incident. In the main, local authorities are required to categorise food hazards, and notify the FSA by the quickest possible means if an incident is either a widespread, or a localised but serious hazard. At the time of this incident, the Food Law Code of Practice, England , 2017 was in place, which required notification to the FSA for 'allergi incidents or if 'any deaths associated with the incident,' occurred. These requirements were strengthened in a review of the practice that led to the March 2021 version. This provides more details on requirements to notify the FSA as a result of an incident linked to an allergy. It now requires that the FSA is notified if there are 'undeclared allergens, a serious anaphylaxis reaction requiring medical intervention as a result of allergens in food, hospitalisation, or death as a result of allergens in food'. The FSA requests timely notification in the initial stages of the incident to allow for appropriate assessment and provision of food safety advice from the FSA, to inform food safety action to be swiftly taken by the food business, on advice and instruction from the competent authority, ordinarily the Local Authority, who is the enforcing authority. It is also not uncommon for the FSA to be notified of an incident by the coroner, at the inquest stage or to learn of deaths as a result of exposure to food from the press on conclusion of an inquest. In such an instance, the FSA's role is limited to providing the necessary policy advice, access to subject matter experts, international communications through the International Food Safety Authorities Network (INFOSAN). As part of routine improvements and drive for efficiency, the FSA is currently producing an internal standard operating procedure for dealing with serious illness and fatality incidents, which includes incidents of anaphylaxis. Our aim is to ensure we take a robust and consistent approach to such occurrences. This procedure will include detail of how we can make local authorities aware of such occurrences at the earliest time possible (if the FSA is notified through other means in the first instance). Additionally, the FSA is developing training for local authorities on incident Floors 6 & 7, Clive House 70 Pe France, London SW1 H 9EX Email: food.gov.uk/ratings For inlocmation on Ole FSA's Privacy Poliey, click~. For flJ1111er lnfonttatlon on how we handle yoU< personal dala please dld(J:lfIB or enter. h\Jps-//wWw food.gov 1!!<fa9pc1.ustptjvacy.09Jice-gjv;,10-0(Jjce-oorrespongence into ~our web browser.
management, including detection, reporting and incident response to compliment the Food Law Code of Practice, and the Practice Guidance, that is planned for roll out in 2023/24. You have also noted that The FSA could assist with current practices offood labelling". The FSA is responsible for food safety labelling in England, Wales and Northern Ireland and I will discuss this in more detail later in this response. Your concerns regarding pathology have been noted, however this is not an area where the FSA has policy responsibility. I can see that your report has been directed to the Department for Health and Social Care (DHSC} and the Royal College of Pathologists who may be able to offer a response to these concerns. We are however, open to assisting other government departments where we can. Reporting and recording You recommended establishing"... a robust system of capturing and recording cases of anaphylaxis, and specifically, fatal and near-fatal anaphylaxis, to provide an early warning of the risk posed to allergic individual by products with undeclared allergen content" and noted that such a system could involve mandatory reporting and indicated how this might work. The FSA is responsible for food safety labelling and food allergy policy in England, Wales and Northern Ireland (Food Standards Scotland have this responsibility in Scotland). When a food business considers or has reason to believe that a food it has placed on the market is injurious to health, they are required to notify competent authorities such as a local authority who are in turn required to notify the FSA of serious or widespread incidents (or notify the FSA directly where we are the competent authority, e.g. food businesses approved by the FSA). There are, however, circumstances where no, or no timely, notification is provided. In these cases, a mechanism by which the FSA is made aware of cases of anaphylaxis (fatal or near fatal) would be very helpful. You have suggested a "mandatory reporting of anaphylaxis presenting to hospitals' similar to the system in place for notifiable diseases. The FSA would not be able to introduce such as a system as it would fall within the remit of DHSC. I would however, like to make you aware of the following: The FSA-funded NHS Data projectl was established to monitor trends in the occurrence of severe, food induced allergic reactions. This work includes the establishment of a UK Anaphylaxis Registry to collect data relating allergic reactions to both food and non-food triggers. While the Registry is not aimed at aiding the investigation of incidents, the questionnaire completed by patients when reporting reactions to the Registry is being updated to includes details on how to contact their local authority's food safety team to report an incident. 1 www.food.gov .uk/research/food-allergy-and-intolerance-research/using-nhs-data-to-monitor-trends-in-the-occurrence- of-severe-food-induced-allergic-reactions Floors 6 & 7, Clive Hollsa 70Pe Email: food'.gov.uk/ratings For inrom1alloo on the FSA's Privacy Policy, dick~. For lurlher information 011 hOIY we hand!& your personal dala please di<:kJJ§I§or enter: bllllS?!l'/WW food.qov.uk/ooout-us1p1ivacy•notice-prival,Hlflirn-cormspondern:e into your web browser.
Additionally In 2021, the FSA provided one-off funding to enable the UK Fatal Anaphylaxis Register (UKFAR) to be updated and maintained. The UKFAR, overseen by the British Society for Allergy and Clinical Immunology, is an active register of deaths from anaphylactic reactions, including food allergies which provides a long-term source of data to improve our understanding of the causes of anaphylaxis related fatalities. This work will help the FSA in its work to reduce numbers of food-related anaphylactic reactions. Wording used on products You raised concern that the "publics understanding of. .. " phrases such as "free from and "vegan" " ... in terms of implying the absence of a particular allergen, can be potentially misleading". You also stated that hFoods labelled in this way must be free from that allergen, and there should be a robust system to confirm the absence of the relevant allergen in all ingredients and during production when making such a claim. " You also suggested that as an interim measure, it may be necessary to clarify that foods with such claims may not be safe for those with the most severe food allergies. 'Free-from' and 'vegan' labelling have different purposes - a "free-from" allergen claim is an absolute claim and should only be used following a rigorous assessment of the ingredients, process and environment. Vegan labelling is not intended to be food safety labelling and there is currently no legal definition of the term "vegan"; vegan ism is a lifestyle choice based on a range of factors, including ethical, environmental, and nutritional choice. While vegan food should not contain animal products the Vegan Society advise that their Vegan Trademark can be used on food carrying a precautionary allergen label (a voluntary statement such as "may contain" to communicate the risk of the unintentional presence of an allergen in a food) for animal products provided that the labelling decision is based on a thorough risk assessment of cross-contamination . There is no specific UK legislation covering "free-from" (with the exception of "gluten-free) or "vegann claims. Any such claims are therefore regulated in accordance with the provisions of General Food Law which provides that voluntary labelling information shall not mislead the consumer or be ambiguous or confusing to the consumer. For any free-from claim to be considered not misleading, it would need to be an analytical zero (where the allergen concerned cannot be detected using the best and most appropriate method of detection). There is information on this subject on our website. There is also FSA endorsed guidance from the Food and Drink Federation (FDF) regarding the use of vegan and free from claims on food. The FDF promotes this guidance regularly and the FSA also signposts businesses to it for best practice. We are in the process of updating our allergen technical guidance to say that precautionary allergen statements should not be used in combination with a 'free from' statement for the same allergen. This work is ongoing and will be put out for further consultation shortly. Floors 6 & 7, Clive House 70Pe ~ Email--- food.gov.uk/rati ngs For intcrmation " " \'le FSA's Prtvacy Policy, click~ For rurthat information on hoW wa handle yoUf personal data p!ease cltd<. here or enter: hUps:IN1Ww.lood.qov.uk/aboul-us/pfivacy,oo!ice 4privafe·office-coJrnsportrl611ce into your web browser.
We will consider how best to promote the current guidance to businesses producing foods with these claims to encourage best practice more widely and continue to consider it alongside our work on precautionary allergen labelling. Additionally, to improve our understanding of consumer perceptions in these areas we are considering carrying out some behavioural research looking at vegan foods with the prospect of an educational campaign around vegan food not always being suitable for those with food hypersensitivities (those with a food allergy, intolerance or coeliac disease). Investigation hotline and best practice You recommended a "hotline to the FSA to provide guidance in fatal cases due to suspected anaphylaxis" and "nationally recognised best practice and technical advice to assist those investigating such cases. As mentioned above, the responsibility and power for such investigations does not sit with the FSA, therefore we would not be best placed to provide such a hotline. The FSA Food Law Code of Practice for local authorities includes guidance on contacting the FSA at the earliest opportunity where affected (potential) hazardous food is distributed beyond the authority's boundaries and/or where the hazard is serious, within the local authorities boundaries. A direct phone line and 24/7 365 days per year email address is in place at the food incidents teams at the FSA to receive these notifications. The Food Law Code of Practice also confirms that cross borough issues require agreement for one authority to take a lead to investigate. The FSA provide support and communications through food alerts etc. The FSA's commitment to improve the quality of life for people with a food hypersensitivity Reducing harm from food hypersensitivity is a fundamental part of the FSA's remit and our work in this area aims to improve the quality of life for people living with food hypersensitivity and support them to make safe, informed food choices to effectively manage risk. Since we published our new FSA Strategy (2022 to 2027) and workplan last year, the FSA is facing additional pressures, including significant new areas of work which in order to deliver has meant making some difficult decisions in some areas of our proposed programme. In addition to our core activities on food hypersensitivity we will ensure that the review of Retained EU Law retains current protections for people with a food hypersensitivity. In our wider food hypersensitivity programme we will focus on a smaller subset of priorities in three key areas:
• Precautionary Allergen Labelling (PAL) will be the priority amongst the three, focusing on improving the way PAL is applied by industry, and its effectiveness as a consumer information tool. Floors 6 & 7, Clive House 70Pe~ Email- food.gov.uk/ratings F°'information on lhe FSA's Ptillacy Policy, click tlfl!a. F°' fu<lher lnforrnolion or, how we handle your personal data please click ~ orM ter. h"ps·//\Y)WJ.food.9ov.uk/abo1jlj1s~1;Y-QOlice-prill>lle-offioe.co«espol\'Jence Into your web browser. J
• improving the provision of information for consumers in the non-prepacked sector (out of home), with a focus on the accuracy of information.
• enabling a step-change in the knowledge, skills and food safety culture of staff in the 'non-prepacked' sector through training. Key to the success of this work is ensuring food businesses, consumer groups, enforcement bodies and other government departments work together on this important issue and the FSA will continue its role as a convener to ensure that this happens. I would once again like to extend the FSA's deepest condolences to the family of Celia Marsh and hope that the work we are doing will help to prevent future occurrences of incidents like this.
Response received
View full response
Dear Ms Voisin, Thank you for sending the FDF a copy of your report into the death of Celia Marsh. We welcome your observations on the need for appropriate allergen labelling which is not misleading to consumers. Ensuring food is safe is fundamental, and of upmost importance to all food manufacturers. When this is not the case, particularly when it tragically leads to a fatality, then it is essential we understand what went wrong and take any steps required to ensure the food is safe in the future. We recognise the need to provide clear, accurate information to food hypersensitive consumers. To support food manufacturers provide appropriate labelling, we have developed technical guidance, working in collaboration with the Food Standards Agency (FSA) as our regulator, other industry bodies like the British Retail Consortium (BRC) and non- governmental organisations like Anaphylaxis UK. In particular, we consider there are key- differences between "free-from" allergen claims and vegan claims, and believe it is important to ensure food producers understand this and label appropriately. To expand; there is no specific UK or EU legislation covering "free-from" claims. The FDF supports the FSA position that a "free-from claim is a guarantee that the food is suitable for all with an allergy or intolerance" and that "Making free-from claims for foods requires strict controls of ingredients, how they are handled and how they are prepared''. In 2015, aware that a growing number of food business operators - including manufacturers, retailers and caterers - were making such claims for their food products, the FDF produced industry guidance in conjunction with the BRC to explain the appropriate use of "free-from" claims in relation to food allergens. The guide clarifies that a "free-from" claim is the absence of a specific food allergen in any food and must be based on a comprehensive risk assessment accompanied by rigorous controls (which should include analytical testing). This is to ensure that the claim is valid and not misleading. Subsequently with the rapid growth and development of vegan suitable food products, it became clear there was potential for consumers to be confused by vegan claims in terms of their allergy safety. In 2020, the FDF published subsequent guidance on 'allergen'-free and vegan claims to explain the important difference between them. It aims to dispel any misunderstanding that a vegan claim automatically means a food product is safe and suitable for an allergic consumer, as this is not the case. Each claim communicates to different consumer groups, with only the allergen absence claim being food safety information and subject to stringent substantiation. The 'Allergen'-Free & Vegan Claims guidance includes a forward from the FSA and has been commended by the Anaphylaxis UK and the Vegan Society. We have made this guidance freely available so that all food businesses can access it, regardless of whether they are a member of the FDF. It has been widely shared and well received across the UK and internationally, and we will continue to look at ways of promoting this to companies. Food and Drink Federation j 6th Floor 110 Bloomsbury Way! London WC1A 2SL.I Tel: +44 (0)20 7836 2460 11 www.fdf.org.uk Registered office as above. Registered in London with limited liabllity. Cer1ificate of Incorporation no. 210572. VAT number: 761253541. The Food and Drink Federation seeks to ensure that information and guidance it provides are correct but accepts no liability in respect thereof. Such infomiation and guidance are not substitutes for specific legal or other professional advice.
There of course remains a need to be vigilant and to consider what else can be done so that food is labelled appropriately and can be trusted by all consumers. We will continue to support the work of the FSA as it looks to ensure consistent allergen information is provided no matter the setting, and that food is safe for people living with food allergies.
There of course remains a need to be vigilant and to consider what else can be done so that food is labelled appropriately and can be trusted by all consumers. We will continue to support the work of the FSA as it looks to ensure consistent allergen information is provided no matter the setting, and that food is safe for people living with food allergies.
Response received
View full response
Dear Sir, We are writing to respond to the recommendations addressed to the British Retail Consortium (BRC) in the Coroner's report on the enquiry into the death of Celia Marsh. The British Retail Consortium (BRC) is the trade association for UK retail businesses. Our purposeis to make a positive difference to theretail industry and the customers itserves, today and in the future. We tell the story of retail, work with our members to drive positive change and use ourexpertise and influence to create an economic and policy environment that enables retail businesses to thrive and consumers to benefit. Our membership comprises over 200 major retailers - whether operating physical stores, multichannel or pureplay online - plus thousands of smaller, independent retailers through a number of niche retail Trade Associations that are themselves members of BRC. We support ourmemberswith their decision process on whatappears on labels and associated policies, but it is their individual company responsibility to make the decision. We have considered the recommendations with interest. In relation to the first recommendation - to produce vegan products to a 'free-from' standard, with the exemption of 'gluten-free' *, free-from is not legally defined and neither is the term 'vegan'. Businesses have the responsibility to comply with the general principles of General Food Law**, to ensure that food products placed on the market are safe, and the Food Information Regulations..,,., which require the presentation and labelling of products to accurately reflect their nature and to not mislead consumers. In the absence of more specific requirements, the BRC, jointly with the Food and Drink Federation (FDF), worked on a guidance document on how to manufacture and label 'free- frorn' products*tt. The Food Standards Agency and allergy charities were consulted du ring the development process of the document. The document is used by our members and is publicly The Form Rooms, 22 Tower Street, London, WC2H 9N S +44 (0}20 7854 8900 info@brc.org.ul< brc.org.uk Brilish Retail Consortillm - a company limited by guarantee Registered in E11gla11d and Wales No. 405720
Regarding vegan products, our members work to the standards set out by the Vegan Society, or to their own standards which are largely based on the Vegan Society's. These generally recognised standards allow the use of precautionary allergen labelling statements for ingredients such as milk and eggs. 'Free-from' products and vegan or plant-based products are aimed at two different types of customers. 'Free-from' supports customers managing an allergy, while vegan products offer options to customers who have chosen a certain lifestyle. This is reflected in the extensive range of products that are available labelled as 'vegan' compared to the relatively restricted 'free-from' range of products that undergo very rigorous development to ensure that they meet the needs of allergic consumers. Our members take great care in labelling products accurately to avoid any implication that vegan products are suitable for those customers trying to avoid certain allergens. Regarding the second recommendation - including a statement that 'free-from' products are not safe for all allergic consumers - we believe such an explanation should be given by practitioners and allergy clinicians, after patient diagnosis, when explaining and guiding allergic patients on how to manage their diets. The statement could have unintended consequences confusing customers and potentially contradicting what their medical teams have advised and limiting their food choices. The level of severity of allergy varies between individuals, with the majority of allergic people able to consume 'free-from' products safely. Our members take their responsibility very seriously and work with customers, allergy charities and health professionals to understand the needs of allergic consumers. We would be supportive of exploring how we could work with these organisations to help educate consumers about the differences between free from and vegan products. Our industry has always led the way with the provision of a wide range of products for allergic consumers, produced to high standards and presented with accurate and clear information. Both the standards and the information provided to consumers are periodically reviewed. Please do not hesitate to contact us if you wish to discuss any aspects of our response.
Regarding vegan products, our members work to the standards set out by the Vegan Society, or to their own standards which are largely based on the Vegan Society's. These generally recognised standards allow the use of precautionary allergen labelling statements for ingredients such as milk and eggs. 'Free-from' products and vegan or plant-based products are aimed at two different types of customers. 'Free-from' supports customers managing an allergy, while vegan products offer options to customers who have chosen a certain lifestyle. This is reflected in the extensive range of products that are available labelled as 'vegan' compared to the relatively restricted 'free-from' range of products that undergo very rigorous development to ensure that they meet the needs of allergic consumers. Our members take great care in labelling products accurately to avoid any implication that vegan products are suitable for those customers trying to avoid certain allergens. Regarding the second recommendation - including a statement that 'free-from' products are not safe for all allergic consumers - we believe such an explanation should be given by practitioners and allergy clinicians, after patient diagnosis, when explaining and guiding allergic patients on how to manage their diets. The statement could have unintended consequences confusing customers and potentially contradicting what their medical teams have advised and limiting their food choices. The level of severity of allergy varies between individuals, with the majority of allergic people able to consume 'free-from' products safely. Our members take their responsibility very seriously and work with customers, allergy charities and health professionals to understand the needs of allergic consumers. We would be supportive of exploring how we could work with these organisations to help educate consumers about the differences between free from and vegan products. Our industry has always led the way with the provision of a wide range of products for allergic consumers, produced to high standards and presented with accurate and clear information. Both the standards and the information provided to consumers are periodically reviewed. Please do not hesitate to contact us if you wish to discuss any aspects of our response.
Response received
View full response
Dear M.E Voisin Thank you for sending BSACI the Prevention of Future Deaths Report, touching on the tragic death of Celia Marsh and allowing us to respond to this. The British Society for Allergy and Clinical Immunology (BSACI) is the national, professional and academic society which represents the specialty of allergy at all levels. Its aim is to improve the management of allergies and related diseases of the immune system in the United Kingdom, through education, training and research. The BSACI's core aim is to improve allergy care by developing a range of allergy resources for its members in order to support this, including clinical audits, specialty guidelines and through education and training and developing standards. A comprehensive list of UK Allergy clinics run by BSACI members and the expertise they provide is also available on the public area of the BSA CI website. www.bsaci.org The BSACI share all ofthe concerns raised in the report and acknowledge that there are significant areas ofneed around the current shortcomings in both education ofdoctors, repmiing and analysis of anaphylaxis fatalities to safeguard those who suffer from food and other potentially severe allergies. This is something that the BSA CI has a long track record of advocacy around through the National Allergy Strategy Group, www.nasguk.org who have been actively lobbying for improvement. The BSA CI recognise the importance ofimproved education ofdoctors on food avoidance in relation to adults with eczema and will consider holding an educational event (eg: BSA CI Annual Conference) We will address the points in your report which we feel are in our remit to act upon and where actions fall out of our remit, we have made suggestions. We consider and agree with point 2 that healthcare professionals should be better educated around allergies so they are aware of the risks to patients. BSA CI is one of three national organisations that make up The National Allergy Strategy Group (NASG) whose aim is to lobby around areas of government policy in particular allergy education & food safety as well as transport. As a result the NASG have had meetings with policy makers at the DHSC, to enable us to fulfil our key aims which build on the recommendations laid out in our 2021 report - 'Meeting the Challenges of the National Allergy Crisis', with the focus of representation for Allergy. One of the key issues is that most GPs begin their career with no training in allergy, yet 8% of their consultations are allergy related. HCPs in primary care, (including GPs) are unaware of the NICE published guidelines on Food Allergy and Anaphylaxis, the guidance on food allergy is infrequently referred to or implemented by those working
in primary care. On average it takes five visits to the GP before an adequate assessment takes place of the appropriate management pathway. BSA CI (as a member of the NASG) met the then Secretary of State for Care and Mental Health Rt Hon Gillian Keegan. After mnch discnssion there is now support for creating an expert advisory group to inform policy making around allergy at DHSC and NHSE as well as other areas of government, to help improve allergy care. This advisory board would be a collaboration between the National Allergy Strategy Group (which BSACI are part of) and DHSC and would include stakeholders from across government and organisations, where allergy is a relevant issue for policy development. One of the key priority areas is around GP training. In relation to the establishment of a robust system for capturing and recording cases, this is a hugely important issue one that BSACI have been lobbying the FSA and DoH to support. The FSA currently suppmt the UK Anaphy !axis Registry run by Imperial College. The purpose of the registry is to record episodes of significant allergic reactions in the community following unintended allergen exposure. Patients ofany age are eligible for inclusion if they have had an "unintended" allergic reaction to either food or a non-food trigger outside a hospital setting. They are also collecting data on milder reactions presenting to hospital. BSACI and other health care professionals are encouraged to register for access to the online platform to collect data. However BSACI have been collaborating with Manchester Foundation.Trust over the past 18 months by providing governance for the UK Fatal Anaphylaxis Register. Thls register is the only register of its kind in the UK. The aim ofthe register is to proactively collect data to help us understand the risks and causes offatal anaphylaxis by analysing the data to determine what the risks of recurrence are, in order to prevent further deaths. Due to the lack offunding previously the register had not been updated since 2005, however in 2020 it was agreed that The British Society for Allergy and Clinical Immunology (BSACI) would provide governance for the register following a one off £100,000 grant from the FSA. The UK fatal Anaphylaxis Register which was set up in 1992 by to help us understand the risks and causes of fatal anaphylaxis by analysing data to prevent futther deaths. UKFAR is the only National register ofdeaths from fatal anaphylaxis with ethics permission (Rec ref no 05/Q 1405/32), supported by the Confidential Advisory Group, on behalf of Secretary ofHealth. Annual permission is renewed under Section 251 with the Health Research Authority. Annually the contract with the Office ofNational Statistics is negotiated via Data Access agreement to receive and withhold relevant patient identifiable information. This is received on premise ofs42( 4) ofthe Statistics & Research Service Act 2007 as amended by s287 ofthe Health & Social Care Act. A confidentiality agreement with the Manchester Foundation Trust to retain the data on the Trust secure server fulfils pre- requisites for the above two permissions. This is renewed annually with Statement ofAcceptance ofthe role oflnformation Asset Administrator by , who acts as custodian of the registry. While many coroners have called for this function to exist, mechanisms of awareness among those who work in the field has been sub-optimal. The data collection is onerous with in-built delays. Since receiving the funding from FSA, UKF AR has made a concerted effort towards the sole purpose ofthe grant which was to update the backlog ofcases. Due to various recent regulatory changes in data retention, UKF AR has had to update permissions. This led to a re-think and the opportunity to improve liaison with allied agencies based within and outside the NHS which will help reduce existing future such backlogs. However this funding will shortly be running out and after nnmerons attempts to secure continuous funding from the FSA, we have been informed we have not been successful. We then contacted the DoH directly, however they have not responded to our emails. This is a public health issue and therefore the responsibility ofgovernment. So much ground- work has been undertaken with the funding from the FSA, however in order to prevent future deaths from anaphylaxis UKF AR requires on-going funding now.
25 The grant has allowed investment towards time of a senior research nurse and an administrative assistant conh·ibuting 2 sessions each week, payment to from Allergy Action and to The Office ofNational Statistics to continue to receiving annual data. This has facilitated
- a catalogue of cases of fatal anaphylaxis with preliminary infmmation with the highlighting insufficiencies
- communication with many agencies requesting relevant outstanding information for cases in the backlog
- delineating cases where insufficient information has been received where further information may provide clarity, we have pursed these with follow up requests
- A session each week for (Custodian ofthe register) to direct the work of colleagues by providing senior support for justification ofrequests and receipt of confidential information
-Enquires for cases prior to 2010 which have had no responses of 'no information' on file, where files have been destroyed or simply we have had 'no responses' in many cases. UKFAR continue to pursue these, plans and have been already set into motion.
-For best chances of data retrieval, we have focussed our work on the last ten years in the first instance. The data available and analysed thus far has been shared as Appendix I ofthis document
- strategic engagement to create links with allied agencies has been successfully made. These are outlined in Appendix 2 ofthis document. Appendix 1. A macroscopic view of the data gathered so far (likely to change as more cases are analysed) is as follows: Cause per year as per ONS data 20 I 15 10 5 11 I I I 0 l1 t. I
• i I1 .; 1I • 2012 2013 2014 2015 2016 2017 2018 2019 2020 !!!!FOOD r21DRUG kl ANAEST STING I@! IDIOPATHIC El Fatal asthma UNKNOWN
We have all the processes in place for this system of proactively recording deaths through our web of linkages in the UK which will benefit everyone concerned in learning lessons and attempting to reduce future deaths from anaphylaxis. Our extensive work has repeatedly highlighted the issue of incorrect food labelling resulting in fatal anaphylaxis and we support any initiative taken by the retail industry to improve and clarify these labels to ensure the safety ofpeople with food allergies. Appendix2 A representation of linkages initiated following the grant been awarded from FSA illustrated below Resuscitation council Links made, need on-gQJ!lE_Ell}~agement with key NHS allies regarding. current case information on a ~stematic basis Royal College of Pathologists and BRIPPA SUDC PICA Net, ICNARC Key non-NHS organisations links for UKFAR BSACI, Hazel Gowland Not yet established Coroner's Society Patient support organisations (NARF, AC, Allergy UK) Links with FSA Data sources ONS (current source) Under discussion 2022 Scotland Wales N Ireland HES /NHS Digital Aspiration- Development of capacity to resurrect PM stomach content analysis which existed till 3 years ago Sampling for Whole genome sequencing in these fatal cases Governed by BSACI the membership ofthis UKFAR steering committee consists ofa wide team ofUK experts committeed to helping progress UKF AR and build linkeages to the above, so we are able to facilitate the work on UKF AR. Groundwork for information sharing this past year has been extensive, however this will all stop ifwe are unable to secure further funding for UK Fatal Anaphylaxis Register. Kind Regards
BSACI ChiefExecutive
in primary care. On average it takes five visits to the GP before an adequate assessment takes place of the appropriate management pathway. BSA CI (as a member of the NASG) met the then Secretary of State for Care and Mental Health Rt Hon Gillian Keegan. After mnch discnssion there is now support for creating an expert advisory group to inform policy making around allergy at DHSC and NHSE as well as other areas of government, to help improve allergy care. This advisory board would be a collaboration between the National Allergy Strategy Group (which BSACI are part of) and DHSC and would include stakeholders from across government and organisations, where allergy is a relevant issue for policy development. One of the key priority areas is around GP training. In relation to the establishment of a robust system for capturing and recording cases, this is a hugely important issue one that BSACI have been lobbying the FSA and DoH to support. The FSA currently suppmt the UK Anaphy !axis Registry run by Imperial College. The purpose of the registry is to record episodes of significant allergic reactions in the community following unintended allergen exposure. Patients ofany age are eligible for inclusion if they have had an "unintended" allergic reaction to either food or a non-food trigger outside a hospital setting. They are also collecting data on milder reactions presenting to hospital. BSACI and other health care professionals are encouraged to register for access to the online platform to collect data. However BSACI have been collaborating with Manchester Foundation.Trust over the past 18 months by providing governance for the UK Fatal Anaphylaxis Register. Thls register is the only register of its kind in the UK. The aim ofthe register is to proactively collect data to help us understand the risks and causes offatal anaphylaxis by analysing the data to determine what the risks of recurrence are, in order to prevent further deaths. Due to the lack offunding previously the register had not been updated since 2005, however in 2020 it was agreed that The British Society for Allergy and Clinical Immunology (BSACI) would provide governance for the register following a one off £100,000 grant from the FSA. The UK fatal Anaphylaxis Register which was set up in 1992 by to help us understand the risks and causes of fatal anaphylaxis by analysing data to prevent futther deaths. UKFAR is the only National register ofdeaths from fatal anaphylaxis with ethics permission (Rec ref no 05/Q 1405/32), supported by the Confidential Advisory Group, on behalf of Secretary ofHealth. Annual permission is renewed under Section 251 with the Health Research Authority. Annually the contract with the Office ofNational Statistics is negotiated via Data Access agreement to receive and withhold relevant patient identifiable information. This is received on premise ofs42( 4) ofthe Statistics & Research Service Act 2007 as amended by s287 ofthe Health & Social Care Act. A confidentiality agreement with the Manchester Foundation Trust to retain the data on the Trust secure server fulfils pre- requisites for the above two permissions. This is renewed annually with Statement ofAcceptance ofthe role oflnformation Asset Administrator by , who acts as custodian of the registry. While many coroners have called for this function to exist, mechanisms of awareness among those who work in the field has been sub-optimal. The data collection is onerous with in-built delays. Since receiving the funding from FSA, UKF AR has made a concerted effort towards the sole purpose ofthe grant which was to update the backlog ofcases. Due to various recent regulatory changes in data retention, UKF AR has had to update permissions. This led to a re-think and the opportunity to improve liaison with allied agencies based within and outside the NHS which will help reduce existing future such backlogs. However this funding will shortly be running out and after nnmerons attempts to secure continuous funding from the FSA, we have been informed we have not been successful. We then contacted the DoH directly, however they have not responded to our emails. This is a public health issue and therefore the responsibility ofgovernment. So much ground- work has been undertaken with the funding from the FSA, however in order to prevent future deaths from anaphylaxis UKF AR requires on-going funding now.
25 The grant has allowed investment towards time of a senior research nurse and an administrative assistant conh·ibuting 2 sessions each week, payment to from Allergy Action and to The Office ofNational Statistics to continue to receiving annual data. This has facilitated
- a catalogue of cases of fatal anaphylaxis with preliminary infmmation with the highlighting insufficiencies
- communication with many agencies requesting relevant outstanding information for cases in the backlog
- delineating cases where insufficient information has been received where further information may provide clarity, we have pursed these with follow up requests
- A session each week for (Custodian ofthe register) to direct the work of colleagues by providing senior support for justification ofrequests and receipt of confidential information
-Enquires for cases prior to 2010 which have had no responses of 'no information' on file, where files have been destroyed or simply we have had 'no responses' in many cases. UKFAR continue to pursue these, plans and have been already set into motion.
-For best chances of data retrieval, we have focussed our work on the last ten years in the first instance. The data available and analysed thus far has been shared as Appendix I ofthis document
- strategic engagement to create links with allied agencies has been successfully made. These are outlined in Appendix 2 ofthis document. Appendix 1. A macroscopic view of the data gathered so far (likely to change as more cases are analysed) is as follows: Cause per year as per ONS data 20 I 15 10 5 11 I I I 0 l1 t. I
• i I1 .; 1I • 2012 2013 2014 2015 2016 2017 2018 2019 2020 !!!!FOOD r21DRUG kl ANAEST STING I@! IDIOPATHIC El Fatal asthma UNKNOWN
We have all the processes in place for this system of proactively recording deaths through our web of linkages in the UK which will benefit everyone concerned in learning lessons and attempting to reduce future deaths from anaphylaxis. Our extensive work has repeatedly highlighted the issue of incorrect food labelling resulting in fatal anaphylaxis and we support any initiative taken by the retail industry to improve and clarify these labels to ensure the safety ofpeople with food allergies. Appendix2 A representation of linkages initiated following the grant been awarded from FSA illustrated below Resuscitation council Links made, need on-gQJ!lE_Ell}~agement with key NHS allies regarding. current case information on a ~stematic basis Royal College of Pathologists and BRIPPA SUDC PICA Net, ICNARC Key non-NHS organisations links for UKFAR BSACI, Hazel Gowland Not yet established Coroner's Society Patient support organisations (NARF, AC, Allergy UK) Links with FSA Data sources ONS (current source) Under discussion 2022 Scotland Wales N Ireland HES /NHS Digital Aspiration- Development of capacity to resurrect PM stomach content analysis which existed till 3 years ago Sampling for Whole genome sequencing in these fatal cases Governed by BSACI the membership ofthis UKFAR steering committee consists ofa wide team ofUK experts committeed to helping progress UKF AR and build linkeages to the above, so we are able to facilitate the work on UKF AR. Groundwork for information sharing this past year has been extensive, however this will all stop ifwe are unable to secure further funding for UK Fatal Anaphylaxis Register. Kind Regards
BSACI ChiefExecutive
Response received
View full response
Dear Ms Voisin,
Thank you for your letter of 21 November 2022 to the Department of Health and Social Care about the death of Celia Marsh. I am replying as Minister with responsibility for Primary Care and Public Health, and I thank you for the additional time allowed. Firstly, I would like to say how deeply saddened I was to read of the circumstances of Ms Marsh’s death. I can appreciate how distressing her death must be for her family and others who knew and loved her, and I offer my heartfelt condolences. It is vital that we take the learnings from what happened to Ms Marsh in order to prevent future deaths. The circumstances your report describes are very concerning and I am grateful to you for bringing these matters to my attention. In preparing this response, Departmental officials have made enquiries with the Food Standards Agency (FSA) as well as the UK Health Security Agency (UKHSA).
Capturing and recording cases of anaphylaxis As articulated in your report, these recommendations refer to establishing a robust system of capturing and recording cases of food-related anaphylaxis cases. The Department of Health and Social Care notes the recommendation and concurs that it is essential we learn from tragedies such as Ms Marsh. Data regarding all anaphylaxis- related deaths in England and Wales are documented by the Office for National Statistics. The British Society for Allergy and Clinical Immunology also holds a register to capture
DQGOHDUQIDWDOFDVHVRIDQDSK\OD[LVZKLFKKDVEHHQRSHUDWLRQDOVLQFH ±WKH8.)DWDO $QDSK\OD[LV5HJLVWHU$OLQNWRWKH5HJLVWHUIROORZV KWWSV ZZZEVDFLRUJSURIHVVLRQDOUHVRXUFHVEVDFLUHJLVWULHVXNIDU ,KRSHWKLVUHVSRQVHLVKHOSIXO7KDQN\RXIRUEULQJLQJWKHVHFRQFHUQVWRP\DWWHQWLRQ <RXUVVLQFHUHO\ 1(,/2¶%5,(103
Thank you for your letter of 21 November 2022 to the Department of Health and Social Care about the death of Celia Marsh. I am replying as Minister with responsibility for Primary Care and Public Health, and I thank you for the additional time allowed. Firstly, I would like to say how deeply saddened I was to read of the circumstances of Ms Marsh’s death. I can appreciate how distressing her death must be for her family and others who knew and loved her, and I offer my heartfelt condolences. It is vital that we take the learnings from what happened to Ms Marsh in order to prevent future deaths. The circumstances your report describes are very concerning and I am grateful to you for bringing these matters to my attention. In preparing this response, Departmental officials have made enquiries with the Food Standards Agency (FSA) as well as the UK Health Security Agency (UKHSA).
Capturing and recording cases of anaphylaxis As articulated in your report, these recommendations refer to establishing a robust system of capturing and recording cases of food-related anaphylaxis cases. The Department of Health and Social Care notes the recommendation and concurs that it is essential we learn from tragedies such as Ms Marsh. Data regarding all anaphylaxis- related deaths in England and Wales are documented by the Office for National Statistics. The British Society for Allergy and Clinical Immunology also holds a register to capture
DQGOHDUQIDWDOFDVHVRIDQDSK\OD[LVZKLFKKDVEHHQRSHUDWLRQDOVLQFH ±WKH8.)DWDO $QDSK\OD[LV5HJLVWHU$OLQNWRWKH5HJLVWHUIROORZV KWWSV ZZZEVDFLRUJSURIHVVLRQDOUHVRXUFHVEVDFLUHJLVWULHVXNIDU ,KRSHWKLVUHVSRQVHLVKHOSIXO7KDQN\RXIRUEULQJLQJWKHVHFRQFHUQVWRP\DWWHQWLRQ <RXUVVLQFHUHO\ 1(,/2¶%5,(103
Response received
View full response
Sent: Tue Sep 03 2024 10:42:46 BST Subject: RE: Coroner's Regulation 28 Report/PFD report
The Royal College of Pathologists is currently updating its autopsy practice guidelines for suspected acute anaphylaxis. The updated guidelines will include contact details for the UKFAR and direct pathologists to report fatal anaphylaxis cases to the UKFAR.
Looking at the wider picture of allergy services, we would highlight that College data suggests that the immunology/allergy workforce in the UK is significantly under-resourced with many services lacking sufficient staffing, and several services being single handed, and vulnerable to closure.
We would echo the Coroner's call for national leadership, better funding and planning for allergy services. There is an NHSE CRG for immunology and allergy, but their remit does not cover the whole breadth of allergy, nor do they have a specific remit for workforce planning in allergy. There remain substantial gaps in the provision of allergy services in the UK which require urgent addressing.
Please don’t hesitate to reach out if you have any further questions.
Thank you, Senior Professional Guidelines Officer
The Royal College of Pathologists 6 Alie Street, London, E1 8QT
Website: www.rcpath.org
The Royal College of Pathologists is currently updating its autopsy practice guidelines for suspected acute anaphylaxis. The updated guidelines will include contact details for the UKFAR and direct pathologists to report fatal anaphylaxis cases to the UKFAR.
Looking at the wider picture of allergy services, we would highlight that College data suggests that the immunology/allergy workforce in the UK is significantly under-resourced with many services lacking sufficient staffing, and several services being single handed, and vulnerable to closure.
We would echo the Coroner's call for national leadership, better funding and planning for allergy services. There is an NHSE CRG for immunology and allergy, but their remit does not cover the whole breadth of allergy, nor do they have a specific remit for workforce planning in allergy. There remain substantial gaps in the provision of allergy services in the UK which require urgent addressing.
Please don’t hesitate to reach out if you have any further questions.
Thank you, Senior Professional Guidelines Officer
The Royal College of Pathologists 6 Alie Street, London, E1 8QT
Website: www.rcpath.org
Report Sections
Investigation and Inquest
On 17/01/2018 I commenced an investigation into the death of Celia Lindsey MARSH. The investigation concluded at the end of the inquest on 22nd September 2022.
The medical cause of death was found by me to be: 1a) Anaphylaxis triggered by the consumption of milk protein.
Based on the evidence I considered that the appropriate wording for Section 3 of the Record of Inquest form answering the questions “How, when and where the deceased came by her death should be as follows:
Celia Marsh died on 27th December 2017 at Royal United Hospital, Bath. She had a known allergy to milk. On that day whilst in Bath City Centre she ate a super veg rainbow flatbread which she believed was safe to eat; she suffered an anaphylaxis reaction caused by milk protein which was in an ingredient within the wrap; this caused her to collapse and despite the efforts of the medical teams involved she died.
The conclusion of the inquest was a narrative which read as follows:
Celia was allergic to milk, she suffered anaphylaxis caused by the consumption of a wrap; the wrap was contaminated with milk protein. Celia was not aware that the wrap contained milk protein. The wrap contained a product which was marked as “dairy free coconut yogurt alternative”, but despite this it contained milk protein, which was the cause of Celia’s anaphylaxis. A product which is marked “dairy-free” should be, free from dairy. The contamination arose because an ingredient in the yogurt called HG1 had become cross-contaminated with milk protein during its manufacture. The manufacturer of the dairy free yogurt had in its possession documents which flagged this risk but this risk was not passed on to its customers.
The medical cause of death was found by me to be: 1a) Anaphylaxis triggered by the consumption of milk protein.
Based on the evidence I considered that the appropriate wording for Section 3 of the Record of Inquest form answering the questions “How, when and where the deceased came by her death should be as follows:
Celia Marsh died on 27th December 2017 at Royal United Hospital, Bath. She had a known allergy to milk. On that day whilst in Bath City Centre she ate a super veg rainbow flatbread which she believed was safe to eat; she suffered an anaphylaxis reaction caused by milk protein which was in an ingredient within the wrap; this caused her to collapse and despite the efforts of the medical teams involved she died.
The conclusion of the inquest was a narrative which read as follows:
Celia was allergic to milk, she suffered anaphylaxis caused by the consumption of a wrap; the wrap was contaminated with milk protein. Celia was not aware that the wrap contained milk protein. The wrap contained a product which was marked as “dairy free coconut yogurt alternative”, but despite this it contained milk protein, which was the cause of Celia’s anaphylaxis. A product which is marked “dairy-free” should be, free from dairy. The contamination arose because an ingredient in the yogurt called HG1 had become cross-contaminated with milk protein during its manufacture. The manufacturer of the dairy free yogurt had in its possession documents which flagged this risk but this risk was not passed on to its customers.
Circumstances of the Death
Celia had known adult-onset allergy to cow’s milk protein. On 27th December 2017 she was shopping with her family in Bath City Centre. She purchased a wrap from Pret a Manger and it appears likely that she had been reassured that the wrap was dairy-free. After eating the wrap, she suffered a severe anaphylaxis reaction to the milk protein in the wrap and died.
An investigation by the Bath and North East Somerset Trading Standards and indeed others traced the dairy to a product in the wrap which was made by Planet Coconut and marketed as a dairy free coconut yogurt alternative.
It was also found that the ingredient in the dairy free yogurt that caused the contamination was called HG1.
An investigation by the Bath and North East Somerset Trading Standards and indeed others traced the dairy to a product in the wrap which was made by Planet Coconut and marketed as a dairy free coconut yogurt alternative.
It was also found that the ingredient in the dairy free yogurt that caused the contamination was called HG1.
Copies Sent To
Pret a Manger Ltd
Planet Coconut
Bath and North East Somerset Counsel
following
Inquest Conclusion
Celia Marsh died on 27th December 2017 at Royal United Hospital, Bath. She had a known allergy to milk. On that day whilst in Bath City Centre she ate a super veg rainbow flatbread which she believed was safe to eat; she suffered an anaphylaxis reaction caused by milk protein which was in an ingredient within the wrap; this caused her to collapse and despite the efforts of the medical teams involved she died.
The conclusion of the inquest was a narrative which read as follows:
Celia was allergic to milk, she suffered anaphylaxis caused by the consumption of a wrap; the wrap was contaminated with milk protein. Celia was not aware that the wrap contained milk protein. The wrap contained a product which was marked as “dairy free coconut yogurt alternative”, but despite this it contained milk protein, which was the cause of Celia’s anaphylaxis. A product which is marked “dairy-free” should be, free from dairy. The contamination arose because an ingredient in the yogurt called HG1 had become cross-contaminated with milk protein during its manufacture. The manufacturer of the dairy free yogurt had in its possession documents which flagged this risk but this risk was not passed on to its customers.
The conclusion of the inquest was a narrative which read as follows:
Celia was allergic to milk, she suffered anaphylaxis caused by the consumption of a wrap; the wrap was contaminated with milk protein. Celia was not aware that the wrap contained milk protein. The wrap contained a product which was marked as “dairy free coconut yogurt alternative”, but despite this it contained milk protein, which was the cause of Celia’s anaphylaxis. A product which is marked “dairy-free” should be, free from dairy. The contamination arose because an ingredient in the yogurt called HG1 had become cross-contaminated with milk protein during its manufacture. The manufacturer of the dairy free yogurt had in its possession documents which flagged this risk but this risk was not passed on to its customers.
Similar PFD Reports
Reports sharing organisations, categories, or themes with this PFD
Related Inquiry Recommendations
Public inquiry recommendations addressing similar themes
Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.