FOOD STANDARDS AGENCY (FSA) - WRITTEN EVIDENCE (FDO0093)
Summary
1. The Food Standards Agency (FSA) is an independent, non-ministerial department, established in 2000. Our mission is ‘food you can trust’, and our vision for the food system is one in which food is safe, food is what it says it is and food is healthier and more sustainable. Our Strategy sets out our guiding principles and our roles as a policy maker, regulator, evidence generator, watchdog and convenor and collaborator.
2. The FSA works across England, Wales and Northern Ireland. We have a legal duty to protect public health from risks arising from the consumption of food, with a remit to protect the interests of consumers in relation to food. This includes providing information and advice to the public in connection with food safety, as well as wider consumer interests, especially matters affecting consumers’ capacity to make informed decisions about food.
3. In addition to scientific research on the safety of food, we conduct social research to understand consumer interests. To fulfil our roles as a regulator and protector of consumer interests, we seek to amplify the consumer voice in food policy, both within the FSA and across Government. That work is underpinned by the latest science and evidence.
4. Transparency is our guiding principle and key to maintaining public confidence, which is why we hold open Board meetings to agree our work and publish our research.
5. We have a range of policy responsibilities across England, Wales and Northern Ireland.
FSA Policy Responsibilities | ||
England, Wales & Northern Ireland | Wales & Northern Ireland | Northern Ireland only |
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6. We work closely with Food Standards Scotland (FSS) and governments in Wales and Northern Ireland and the UK government, as part of our commitment to four-country working. FSS is an independent public body with responsibility for food policy and implementation in Scotland.
1.1. Why the FSA is submitting evidence
7. The aim of the Committee inquiry is to consider the role of foods, such as ‘ultra-processed foods’ (UPF) and foods high in fat, sugar and salt (HFSS) in a healthy diet, including how they influence health outcomes. The Committee’s call for written evidence is also assessing how shifts in behaviours and trends have impacted obesity and how government policies have influenced these shifts. As obesity is within the DHSC remit, the FSA response will not provide evidence on obesity or other aspects of nutrition policy.
8. The FSA is however submitting evidence to the Committee for two reasons. Firstly, while dietary health and obesity policy are outside our remit in England, since the public debate on UPF includes discussion of food additives, which we recommend ministers authorise for placement on the market in Great Britain (GB), we include information on how we assess the safety of food additives and the authorisation process. Secondly, the debate on diet and health, including UPF, falls under our remit covering consumer interests in relation to food. UPF has been in the top three issues of concern to consumers since August 2023, with approximately 75% of those surveyed in our Consumer Insights Tracker survey expressing concern.
9. In line with our remit, the evidence we provide responds to questions 1, 5 and 6 as listed in the call for evidence. Our response focuses on the system for approving food additives for safe use in food and on our research into consumer attitudes towards food and diet, including UPF, which is not held elsewhere.
10. The FSA has not independently reviewed the evidence on diet and health but we accept the evidence reviewed by the Scientific Advisory Committee on Nutrition (SACN).
11. The term ‘ultra-processed food’ was developed for the NOVA system of food classification, which categorises food by its degree of processing. There is no legal definition of UPF. Nutritional content is not used to define UPF. According to NOVA, UPF ‘are formulations of ingredients, mostly of exclusive industrial use, typically created by series of industrial techniques and processes'.[1] For NOVA, some food additives are used only in UPF. These are ‘flavours, flavour enhancers, colours, emulsifiers, emulsifying salts, artificial sweeteners, thickeners, and foaming, anti-foaming, bulking, carbonating, gelling and glazing agents’. However, other additives are used in food that is not ‘ultra-processed’, including preservatives.
12. Food additives are substances which are added to food to perform a specific technological function, exerting an effect on a food. These functions include sweetening (without adding sugar), colouring, thickening, regulating acidity and preserving food. Food additives are categorised in law by their function. There are 27 categories and a food additive may fall into more than one category if it performs multiple functions. The full list of categories is given in Annex I of assimilated Regulation No 1333/2008.
13. The legal definition of a food additive is ‘any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food, whether or not it has nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods’.[2]
14. The FSA regulates food additives to allow their safe use in food. A food additive must meet the following conditions to be approved for use in food:
a) It does not, on the basis of the scientific evidence available, pose a safety concern to the health of the consumer at the level of use proposed.
b) There is reasonable technological need that cannot be achieved by other economically and technologically practicable means.
c) Its use does not mislead the consumer as to the true nature of the food.
The potential links between consumption of food containing an additive and obesity fall outside the scope of the regulatory framework for additives.
2.1. The authorisation process
15. The process to authorise a food additive is as follows:
a) Applicant submits application via FSA website (following FSA guidance)
b) FSA checks application
c) Risk assessment - safety assessment and other science and evidence gathered and analysed by FSA and independent experts
d) Risk management - FSA considers approval options (or reasons to refuse)
e) Formal consultation on the options
f) FSA finalises its recommendation
g) FSA makes recommendation to Ministers
h) Ministers make a decision
i) The food additive is authorised for use in food in GB via legislation made by parliamentary process and the register of authorised products is updated
16. During the process the FSA works with Food Standards Scotland, devolved administrations, other government departments and other interested parties to consider the interests of those with responsibilities for food and agriculture, health and trade.
17. All additives that are approved for use in GB can be found on the FSA’s list of Approved additives and E numbers. This is a list of additives that have some form of authorisation, but not all additives listed are authorised for use in all foods. The full list of approved food additives is available in Annexes II and III of assimilated Regulation No. 1333/2008. There are currently 325 additives defined and authorised in the legislation (this does not include flavourings that legally are not food additives and are regulated under a different regime). The list allows regulators and enforcement agencies to know whether an additive is approved.
18. Since becoming responsible for authorising additives in 2021, the FSA receives 7 applications per year on average for new additives to be approved. There are 22 applications being assessed for safety at time of writing.
19. We explain the risk assessment and risk management steps in more detail below.
2.2. Risk assessment
20. Risk assessment estimates what risks to human health, if any, a proposed food additive may pose. Risk assessment of a food additive is performed based on the following factors:
a) Consideration of the specific toxicological profile of the additive
b) The concentration at which it is used in the food categories assessed
c) The range of foods it might be present in
d) The likely overall exposure in the diet, given the amount of food containing the additive expected to be consumed.
21. The FSA does not carry out a risk assessment of the interaction of combinations of additives as they would be consumed in the diet when assessing the single authorisation of a new additive. Furthermore, the category of ultra-processed food does not determine whether specific additives are present or absent, the levels at which they are present or how much of the food is consumed. Consequently, UPF is not a useful category for the risk assessment of food additives.
22. Foods high in fat, salt and sugar (HFSS) are often processed and may also contain additives. For the same reasons stated above in connection to UPF, HFSS is also not a useful term for the risk assessment of additives. Many HFSS foods are UPF, but there are also UPF that are not HFSS and vice versa.
23. Risk assessment takes place before an additive is authorised and additives may be re-evaluated later if new evidence suggests potential concerns or due to a formal programme of review. For example, the additive titanium dioxide (E 171) is in the process of being reviewed in the light of new information becoming available and it no longer being authorised for use in food in the EU. However, food additives are not automatically required to have their authorisation renewed once authorised.
24. Applicants must submit a dossier of evidence demonstrating the safety of the additive for its intended use in food. The FSA undertakes comprehensive scientific suitability checks of each application. The evidence is then the basis of the risk assessment of the additive. The submitted dossier contains information on the identity, stability and manufacturing process of the additive as well as how it behaves in food. For example, whether it breaks down into other compounds. The data provided by the applicant should demonstrate safety of the additive’s proposed use. This could include metabolic studies (how a substance changes in the body and how it is excreted from the body), genotoxicity studies, which assess whether damage is caused to DNA, a range of short- and long-term toxicity studies to consider other relevant outcomes such as if it is safe in pregnancy, whether it could affect particular bodily organs or the immune system. Most of these studies are done in vitro or in laboratory animals, but on occasion, tolerance studies in human volunteers may also be conducted by the applicant and submitted. An exposure assessment would also be provided.
25. Exposure to additives is assessed by using food consumption data from the National Diet and Nutrition Survey (NDNS). NDNS is a rolling programme which has collected 15 years of consumption data, with years 16-20 being launched this year. NDNS captures food consumption amongst a representative sample of people living in private households in the UK. Using known occurrence levels or maximum permitted levels of additives in foods, NDNS data can be used to estimate the UK consumer's exposure to the additive of interest. Exposure may also be monitored through specific consumer surveys.
26. Applications for authorisation may be reviewed by independent groups of experts including by the relevant Joint Expert Group (JEG) and assured or directly reviewed by the parent Scientific Advisory Committee (SAC) and the final opinion on safety (positive, negative or not possible to conclude) is shared with risk managers. The final opinion of the JEG or SAC is published.
27. The FSA can issue a request for further information from the applicant, if the data provided are insufficient to allow them to reach a conclusion. An applicant may withdraw from the process if they cannot or do not wish to address this request.
28. Since beginning to do its own assessments in 2021, following the UK’s exit from the European Union, the FSA has issued no negative opinions, although some opinions where it is not possible to reach a conclusion have been agreed with applicants. Requests for further information have been made for a significant number of applications which are in the process of being addressed by the applicant or the applicant’s response is being assessed. If unsatisfactory, an application can be removed from the authorisation process.
2.3. The FSA Scientific Advisory Committees
29. The FSA’s SACs are called upon to review scientific information and evaluate its relevance to make sure that the FSA’s advice is based on the best and most recent scientific evidence. Recruitment to FSA SACs is based on identified areas of expertise, skills and experience. SAC members are appointed from a wide range of disciplines and include representation from academics, industry, experienced practitioners and consumer representatives. All appointments are based on merit and equal opportunities, with independent assessment, openness and transparency of process as set out in the Code of Practice for Scientific Advisory Committees and Councils (2021).
30. Chairs and members of SACs must make a declaration of interests to the SAC Secretariat. Any potential conflict of interests arising due to members’ interests must be declared and any changes during their membership should be promptly declared to the Secretariat. Each SAC publishes its own Register of Interests online (including the FSA Science Council). Members are required to withdraw from discussion of matters in which there may be any conflict of interest. This is then reflected in the official record of the meeting.
2.4. Risk management
31. Risk managers consider how any risks identified by the risk assessment should be controlled. Alongside food safety, risk management takes into consideration other legitimate factors such as animal welfare, environmental and economic impact and any nation-specific factors that are relevant before deciding whether to recommend authorising the application. Risk managers may set conditions on use of the additive, based on the risk assessment. Conditions include reducing the number of foods in which the additive may be used or lowering the maximum permitted limit to reduce consumers’ exposure to the additive. Other control measures could include setting new specifications for an additive with adjusted purity criteria or additional labelling requirements.
32. Controls are set on a case-by-case basis. For example, the colour Erythrosine has a very low acceptable daily intake and so it is authorised for use only in cocktail cherries to limit consumers’ exposure. We also limit the waxes and coatings applied to fresh fruit. They are only allowed on fruits where the skin is not eaten, as consumers do not expect it on fruits other than citrus such as waxed lemons.
2.5. Food additive labelling
33. All food additives by law must be identified on the label and must include their technological function, i.e. why they were included, along with either their full name or an E number. E.g. ‘Sweetener Sucralose’, or ‘Sweetener E 955’.
34. Foods containing certain additives must be labelled with additional information. For example, any product containing any of the Southampton colours (Sunset yellow (E 110), Quinoline yellow (E 104), Carmoisine (E 122), Allura red AC (E 129), Tartrazine (E 102) or Ponceau 4R (E 124)) must also carry a mandatory warning ‘may have an adverse effect on activity and attention in children’. A further example is that if sweeteners are used, the name of the food must include ‘with sweeteners’. There are mandatory safety warnings for the sweetener aspartame, the polyols, glycyrrhizinic acid, and caffeine in energy drinks. In this way consumers wishing to avoid certain additives either through personal preference or for medical reasons can do so, by looking at the label.
2.6. Specific Additives
2.6.1. Non-nutritive Sweeteners
35. The FSA website lists 22 sweeteners approved for use in foods.
36. The International Agency for Research on Cancer (IARC) report of July 2023 stated that the sweetener aspartame is ‘possibly carcinogenic to humans’ on the basis of ‘limited evidence for cancer in humans’, but the Food and Agriculture Organization of the United Nations (FAO) World Health Organisation Joint Expert Committee on Food Additives (JECFA) say that the ‘data evaluated indicated no sufficient reason to change the previously established acceptable daily intake (ADI)’. The FSA also reviewed the report and the JECFA statement and concluded that aspartame is safe to consume at current permitted use levels.
37. The General Standard for Food Additives (GFSA) of the FAO’s Codex Committee of Food Additives sets international standards for sweeteners. Often UK national standards are stricter than GFSA standards. Our regulations do not authorise additives to be added as sweeteners to foods unless use of the sweetener fully or partially replaces sugars or produces food intended for particular nutritional uses. In most cases, when used as a partial replacement, an energy reduction of at least 30% is required in the final food. Some countries allow sweeteners to be used in staples such as bread, which is not allowed in the UK.
2.6.2. Emulsifiers
38. The FSA website lists 65 approved emulsifiers, stabilisers, thickeners and gelling agents.
39. A number of reports have suggested that emulsifiers might have effects on gastrointestinal permeability. At the time of the European Food Safety Authority’s (EFSA) re-evaluation of emulsifiers, these reports were inconsistent and not independently replicated. A dose response relationship or whether or not such changes occurred in realistic conditions and why they were not observed at higher doses in long term toxicity studies were not identified. EFSA concluded that there was insufficient reason to alter the evaluation at that time but noted that this uncertainty should be reconsidered when the literature was expanded. If any specific emulsifier was believed to pose a risk to health, the FSA would ask the SAC on toxicity to look at its safety. The SAC would examine all available evidence and advise on safety risks. The FSA would then decide whether any further action is required.
40. Whilst re-evaluating some food additives, EFSA reviewed existing additive specifications and recommended that limits for impurities such as heavy metals and by-products formed in the production process should be reduced to reflect the levels currently found and considered achievable from modern production practices. For certain emulsifiers the European Commission has subsequently amended the specifications.
41. The FSA keeps all food additives including emulsifiers under review and on the basis of new evidence will consider whether any action is warranted to change specifications or other conditions of use for food additives, where appropriate seeking advice from our toxicologists and/or independent scientific advisors.
2.6.3. Nitrates and nitrites
42. Potassium nitrite (E 249), Sodium nitrite (E 250), Sodium nitrate (E 251) and Potassium nitrate (E 252) are authorised preservatives, listed on the FSA website.
43. Nitrates occur naturally in the body and some foods. They can also be added to food as preservatives. Nitrates and nitrites salts are added to meat, fish and cheese for preservation and to prevent the growth of Clostridium botulinum - the bacterium responsible for life-threatening botulism. They are also used in meat to keep it red and give flavour and nitrates specifically, are used to prevent certain cheeses from bloating during fermentation.
44. Nitrites and nitrates occur naturally in water and vegetables, especially in green leafy and root vegetables such as lettuce, beets, celery, carrots, and more. Around 80% of the nitrates and nitrites we consume are obtained from the plants we eat; only around 5% come from additives.
45. Nitrites and nitrates provide an important microbial control in a range of foods. However, under certain conditions, such as cooking at high temperatures in the presence of some naturally occurring amines, nitrates and nitrates may be converted to nitrosamines. Nitrosamines have been shown to be genotoxic in vitro and there is evidence that they cause cancer in rodents. Conditions of use and maximum permitted levels have been set for these additives to minimise the risk of formation of nitrosamines that result from the presence of nitrites and nitrates in foods while maintaining the protective effects that they provide against bacteria, in particular C. botulinum.
46. The FSA is currently reviewing the evidence on use levels of nitrates and nitrites, following changes in maximum permitted levels in the EU.
2.7. Enforcement
47. The regulatory framework for food additives is enforced by local authorities. Trading Standards and Environmental Health Officers may use the lists of authorised additives and work with public analysts to ascertain whether the levels of an additive in a food comply with the conditions of its authorisation. If a non-compliant use of an additive is found and its use is unsafe then the product would be recalled and the food business concerned may be liable for penalties. In most cases, non-compliance with the food additives regulations does not pose a risk to public health, for example the use of an additive at a safe level in a food for which is not authorised. In such cases the product must be withdrawn.
48. The FSA regularly conducts research with consumers in England to understand their attitudes and behaviours in relation to food. Twice a year we conduct our Food and You 2 survey with around 3,000 adults. We also conduct a shorter, monthly Consumer Insights Tracker with around 1,800 consumers. These regular surveys are supplemented by more in depth consumer research. These sources provide the data below. There are several differences between the Food and You 2 survey and Consumer Insights Tracker meaning the findings are not directly comparable. This includes how the questions are worded, respondents selected and when surveys are carried out. A summary of differences can be found on the Consumer Insights Tracker webpage.
3.1. Consumers’ attitudes to food
49. Most consumers in England are confident that the food they buy is safe to eat (93%) and that the information on food labels is accurate (87%) (Food and You 2 Wave 6, 2023). This is broadly in line with findings from previous waves conducted in 2020-22.
3.2. Consumers’ concerns about food
50. Our latest research shows that 82% of consumers surveyed in England reported having no concerns about the food they eat (Food and You 2 Wave 6, 2023), broadly in line with previous waves. When those who reported having a concern were asked what their concerns were, the most common concerns related to food safety and hygiene (32%) or food quality (23%). However, 21% of those who had a concern mentioned being concerned about food production methods such as the use of additives, and how food has been produced or processed and 19% mentioned concerns about nutrition or health, including obesity and healthy eating, the amount of sugar, salt or fat in food, or processed food.
51. Although most respondents reported having no concerns about the food they eat, when all respondents were prompted to consider a list of food related issues, food prices (65%), food waste (62%) and food quality (61%) were the most common concerns. Food prices have consistently been the top concern reported in this research since the second quarter of 2022. Slightly fewer respondents were concerned about the amount of sugar (55%), salt (46%), fat (44%), the use of additives like preservatives and colouring (37%) and calories in food (29%), a slightly lower number than in previous waves of the survey. 46% were concerned about being able to eat healthily in general.
3.3. Concerns about UPF
52. In our consumer research, we use a range of terms. For example, Food and You 2 asks consumers about ‘processed food’ and ‘processed meat’ (e.g. chicken nuggets, ham, bacon, sausages, and salami). These terms were tested with consumers to check levels of understanding before they were introduced into the survey. In our Consumer Insights Tracker, we ask about ‘ultra-processed, or over-processing of food’ to reflect the increasing use of the term ‘ultra-processed food’ in the media.
53. Consumers have been asked whether they are concerned about ‘ultra-processed, or over-processing of food’ since August 2023 through our monthly Consumer Insights Tracker, as part of a broader question asking how concerned respondents are about a number of food-related issues. When prompted with a list of topics, around 75% of all respondents in England reported being ‘highly’ or ‘somewhat’ concerned about ultra-processed food (or the over-processing of food) each month (Consumer Insights Tracker, February 2024). It consistently featured as a top three concern out of 14 food issues presented. Concern about UPF appears to be higher among adults aged 55 years and over and those with higher levels of education (a degree, masters or PhD) with around 80% of respondents in these groups reporting concern. However, even for younger respondents and those with lower levels of education, UPF are consistently still one of their top three concerns with around 65% of those with no formal qualifications and 69% of those aged 18-34 reporting concern.
54. These findings are supported by our 2022 research with consumers which found that concerns about the long-term health and safety implications of processed foods were widespread, with many consumers wanting action from government (The UK public’s interests, needs and concerns around food). In England, 61% expressed concerns about the ‘over-processing’ of food in the future. When thinking about food safety regulation, 47% stated they would like the FSA to ‘reduce things added in the food process’ for example, E-numbers and preservatives. Consumers saw unprocessed or minimally processed food choices as too expensive and / or time consuming, highlighting a trade-off that consumers may have to make between healthier food and cost or convenience. 39% of respondents in England said that they ‘often rely on quick to prepare, convenience foods (ready meals, frozen pizza, fish fingers, nuggets etc.)’ and 25% felt that heavily processed foods were the only practical option. Consumers associated multiple negative issues with more processed food, such as being less ethical; less environmentally friendly food production practices; more use of additives, pesticides and hormones; reduced ‘quality’ and ‘safety’ for consumers; and lower animal welfare.
55. Our rapid evidence review on sustainability also found consumers perceive most processed foods to be unhealthy and UPF as highly processed products with additives, artificial ingredients, and low nutritional quality (A rapid evidence assessment of UK citizen and industry understandings of sustainability). However, some processed foods, culinary ingredients and minimally processed foods (such as pasteurised milk, flour, cheese and meat) were also perceived to be ultra-processed.
3.4. Changes to diets and shopping behaviour
56. When we asked consumers what changes they had made to their diets or food shopping behaviour in the last 12 months (from a list of options), the most common reported changes were eating less processed food (40%) and minimising food waste (40%) (Food and You 2 Wave 4, 2022). Other changes people reported making to their diet included eating more fruit and vegetables (32%), eating less meat, poultry or fish (29%), consuming less dairy (14%) and stopping eating meat, fish or poultry completely (2%). 8% had started buying organic foods. Of those who reported reducing their meat consumption, 72% said they had reduced their processed meat intake (e.g. chicken nuggets, ham, bacon, sausages, salami) to be healthier or lose weight. This is based on reported changes by consumers, the FSA does not hold actual purchasing data.
57. The FSA’s rapid evidence assessment of UK citizen and industry understandings of sustainability (2022) which reviewed 102 UK academic papers published between 2020 and 2022 also found evidence to suggest that health was a stronger driver of food behaviours than environmental concerns. It reported that plant-based foods are perceived by consumers as being healthy even though these products can be ultra-processed or high in fat, sugar and salt. It noted the trend towards eating more highly processed plant-based convenience foods compared to a more traditional plant-based diet comprising pulses, vegetables and wholegrain. It reported a 2020 survey that younger people were more likely to eat processed meat and dairy alternatives (e.g. Quorn products or meat-free sausages / burgers) compared to older age groups.
3.5. Food labelling
58. Food labelling is one of the main ways that consumers are provided with food information. There are differing policy responsibilities for food labelling across the UK and FSA. In England, the FSA has policy responsibility for food safety labelling (including allergen labelling). Food labelling policy and food composition policy, where not related to food safety, rests with the Department for Environment, Food and Rural Affairs. Nutrition labelling policy rests with DHSC in England. Within the UK the FSA works with departments and governments according to Common Frameworks principles and arrangements for 4-country working. There is no mandatory nor voluntary labelling scheme intended to identify UPF.
59. In our research into the UK public’s interests, needs and concerns around food (2022), which collected both quantitative (survey) and qualitative data (e.g. from workshops), consumers wanted to understand what food is healthy and nutritious and for it to be easy to make healthy choices. Barriers to this included understanding what ‘healthy’ foods to prioritise, navigating food labelling and marketing, and eating healthily within budget and time constraints. 37% of consumers surveyed reported finding it difficult to really understand what a product contains. Consumers also told us they find it challenging to read and interpret scientific and technical terms, including names of ingredients such as dextrose, and to access clear information about food processing methods. This can make the actual amount of fat, sugar or salt a product contains unclear. Many felt as if they were not supported by the food industry to make healthy choices, and at worst actively misled. When surveyed 61% stated that they ‘often felt that food labelled as ‘healthier options’ (e.g. low fat, low sugar, plant-based meat alternatives) were unhealthy in other ways’, and 54% agreed that they feel supermarkets encourage them to buy unhealthy foods. Some consumers told us they felt that labels and marketing appeared to be providing useful information, whilst actually making their decisions harder. This study also found that 38% of consumers would like to see regulatory action to ‘give more clarity on fat, salt and sugar content in food products’.
60. Our literature review on HFSS (2021) found very little research exploring the acceptability of labelling, beyond whether or not people believed it would be helpful (which strengthened support), and preference for certain formats (for example, clear and concise). The review did not include quantitative data.
3.6. Forthcoming consumer research
61. The FSA’s Advisory Committee on Social Science will conduct a rapid evidence review on consumer understanding, knowledge, behaviours and information needs with respect to UPF (reporting May 2024).
8 April 2024
[1] Monteiro et al. 2019. Ultra-processed foods, diet quality and human health. Rome, FAO.
[2] Chapter I, Article 3, 2(a), Assimilated Regulation No. 1333/2008.