Looking beyond borders: Integrating best practices in benefit–risk analysis into the field of Food and Nutrition

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This page (including the files available for download at the bottom of this page) contains a draft version of a manuscript, whose final version is published and is available in the Food and Chemical Toxicology 50 (2012) 77–93. If referring to this text in scientific or other official papers, please refer to the published final version as: M.J. Tijhuis, M.V. Pohjola, H. Gunnlaugsdóttir, N. Kalogeras, O. Leino, J.M. Luteijn, S.H. Magnússon, G. Odekerken-Schröder, M. Poto, J.T. Tuomisto, Ø. Ueland, B.C. White, F. Holm, H. Verhagen: Looking beyond borders: Integrating best practices in benefit–risk analysis into the field of Food and Nutrition. Food and Chemical Toxicology 50 (2012) 77–93 doi:10.1016/j.fct.2011.11.044 .

Title

Editing Looking beyond borders: Integrating best practices in benefit–risk analysis into the field of Food and Nutrition

Authors and contact information

M.J. Tijhuis, correspondence author

(mariken.tijhuis@rivm.nl)

(National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands)

(Maastricht University, School of Business and Economics, Maastricht, The Netherlands)

M.V. Pohjola

(National Institute for Health and Welfare (THL), Kuopio, Finland)

H. Gunnlaugsdóttir

(Matís, Icelandic Food and Biotech R&D, Reykjavík, Iceland)

N. Kalogeras

(Maastricht University, School of Business and Economics, Maastricht, The Netherlands)

O. Leino

(National Institute for Health and Welfare (THL), Kuopio, Finland)

J.M. Luteijn

(University of Ulster, School of Nursing, Northern Ireland, United Kingdom)

S.H. Magnússon

(Matís, Icelandic Food and Biotech R&D, Reykjavík, Iceland)

G. Odekerken-Schröder

(Maastricht University, School of Business and Economics, Maastricht, The Netherlands)

M. Poto

(University of Turin, Facoltà di Giurisprudenza, Dipartimento di Scienze Giuridiche, Torino, Italy)

(Precon Food Management BV, Bunnik, The Netherlands)

J.T. Tuomisto

(National Institute for Health and Welfare (THL), Kuopio, Finland)

Ø. Ueland

(Nofima, Ås, Norway)

B.C. White

(University of Ulster, Department of Pharmacy & Pharmaceutical Scienes, School of Biomedical Sciences, Ireland, United Kingdom)

F. Holm

(FoodGroup Denmark & Nordic NutriScience, Ebeltoft, Denmark)

H. Verhagen

(National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands)

(Maastricht University, NUTRIM School for Nutrition, Toxicology and Metabolism, Maastricht, The Netherlands)

(University of Ulster, Northern Ireland Centre for Food and Health (NICHE), Northern Ireland, United Kingdom)

Article info

Article history: Available online 2 December 2011

Abstract

An integrated benefit–risk analysis aims to give guidance in decision situations where benefits do not clearly prevail over risks, and explicit weighing of benefits and risks is thus indicated. The BEPRARIBEAN project aims to advance benefit–risk analysis in the area of food and nutrition by learning from other fields. This paper constitutes the final stage of the project, in which commonalities and differences in benefit– risk analysis are identified between the Food and Nutrition field and other fields, namely Medicines, Food Microbiology, Environmental Health, Economics and Marketing–Finance, and Consumer Perception. From this, ways forward are characterized for benefit–risk analysis in Food and Nutrition. Integrated benefit– risk analysis in Food and Nutrition may advance in the following ways: Increased engagement and communication between assessors, managers, and stakeholders; more pragmatic problem-oriented framing of assessment; accepting some risk; pre- and post-market analysis; explicit communication of the assessment purpose, input and output; more human (dose–response) data and more efficient use of human data; segmenting populations based on physiology; explicit consideration of value judgments in assessment; integration of multiple benefits and risks from multiple domains; explicit recognition of the impact of consumer beliefs, opinions, views, perceptions, and attitudes on behaviour; and segmenting populations based on behaviour; the opportunities proposed here do not provide ultimate solutions; rather, they define a collection of issues to be taken account of in developing methods, tools, practices and policies, as well as refining the regulatory context, for benefit–risk analysis in Food and Nutrition and other fields. Thus, these opportunities will now need to be explored further and incorporated into benefit–risk practice and policy. If accepted, incorporation of these opportunities will also involve a paradigm shift in Food and Nutrition benefit–risk analysis towards conceiving the analysis as a process of creating shared knowledge among all stakeholders.

Abbreviations

CVD, cardiovascular disease; DALY, disability adjusted life year; EFSA, European Food Safety Authority; HTA, health technology assessment; QALY, quality adjusted life year.

Keywords

Benefit–risk, Food & nutrition, Best practice, Assessment, Management, Shared understanding

Introduction and approach

Benefit–risk analysis of Food and Nutrition is developing fast. Benefit–risk analysis aims to give guidance in decision situations where both benefits and risks have been identified; when the benefits do not clearly prevail over the risks, explicit weighing of benefits and risks is indicated. Benefit–risk analysis can be seen as a triad of the (1) assessment, (2) management and (3) communication of integrated benefits and risks, analogous to the common contemporary risk analysis paradigm (Fig. 1) (WHO/FAO, 1995).

Benefit–risk assessment of Food and Nutrition comprises a science- based process intended to qualitatively or quantitatively estimate the benefits and risks for humans following exposure (or lack of exposure) to a particular food or food component and includes the potential to integrate them into comparable measures. Benefit– risk management entails the process of weighing policy alternatives in light of the results of benefit–risk assessment and other relevant information. Benefit–risk communication covers the interactive exchange of information and science-based opinions concerning benefits and risks among assessors, managers, consumers and other stakeholders.

The scope of Food and Nutrition risk assessment is fairly well established (Renwick et al., 2003); it deals with the assessment of adverse health effects caused by physical or chemical agents, occurring naturally in foods or as environmental contaminants, or resulting from food preparation or manufacturing processes. However, in the benefit–risk context, the scope of benefit-assessment is a point of discussion. A beneficial effect can be looked at as the reverse of an adverse effect (WHO, 1994), i.e. a physical or other change within a person that improves functional capacity or the capacity to deal with stress or that decreases susceptibility to harmful effects. This can be measured as prevention of disease, i.e. reduction of risk, but currently it is difficult to measure benefits directly, at an early stage or as an ‘above-normal’ capacity. Cases where the benefit is obvious but where different risks are involved (in severity and mechanism) could also be taken under the wing of benefit–risk analysis. Benefit– risk analysis presents up-to-date knowledge in a dynamic public health process, aimed at optimization, i.e. looking for ways to maximize benefits while minimizing risk.

In recent years, many projects have done significant work to identify the possibilities and difficulties of benefit–risk analysis in the Food and Nutrition field (Tijhuis et al., 2011). Much progress has already been made, but benefit–risk thinking and practise have not yet become commonly established. Therefore, for further development, the field of Food and Nutrition could benefit from looking beyond its borders and learning from other fields of research (and possibly also vice versa) and this is the explicit goal of BEPRARIBEAN project (http://en.opasnet.org/w/Bepraribean) (Verhagen et al., 2011). To serve this goal, we recently compiled reviews covering the state of the art in benefit–risk analysis for Food and Nutrition (Tijhuis et al., 2011) and five other fields: Medicines (Luteijn et al., 2011), Food Microbiology (Magnússon et al., 2011), Environmental Health (Pohjola et al., 2011a), Economics and Marketing–Finance (Kalogeras et al., 2011) and Consumer Perception (Ueland et al., 2011). The individual reviews were led by the researchers from within the respective fields and were contributed to by the researchers from the other fields. Summaries of the key issues from the reviews and a summary of the contemporary regulatory context for Food and Nutrition management and assessment are presented in Section 2.

In Section 3, the focus is on identifying how the benefit–risk approaches in the different areas compare to and differ from the benefit– risk approaches in the area of food and nutrition. In order to exemplify the (combined) perspectives and approaches from within the different areas, we include an example of a case: the effects of replacing current animal protein sources by more sustainable dietary protein sources. This topic was considered suitable because it is inherently multi-disciplinary and currently of global interest. This example is meant as an illustration and does not aim to be a conclusive analysis.

From this, in Section 4, we aim to identify opportunities for further development of benefit–risk analysis in food and nutrition.

In Section 5, we sum up the main points of this paper, and the whole BEPRARIBEAN project, and indicate some implications that these points will or may have for Food and Nutrition benefit–risk analysis in the future.

Summaries of key issues by focus area and EU regulatory context for Food and Nutrition

In 2.1–2.6 we summarize the key issues from the 6 state of the art reviews: Food and Nutrition (Tijhuis et al., 2011), Medicines (Luteijn et al., 2011), Food Microbiology (Magnússon et al., 2011), Environmental Health (Pohjola et al., 2011a), Economics and Marketing– Finance (Kalogeras et al., 2011) and Consumer Perception (Ueland et al., 2011). They are complemented in 2.7 with a short overview of the contemporary regulatory context for Food and Nutrition management and assessment in the European Union.

Benefit–risk analysis in Food and Nutrition (Tijhuis et al., 2011)

This paper addresses the three components of benefit–risk analysis, but focuses on assessment. Benefit–risk assessment in Food and Nutrition is geared to weigh the beneficial and adverse effects a food or food component may have, in an integrated measure, in order to make better-informed policy decisions regarding public health issues.

Historically, the assessments of risks and benefits have been separate processes. In risk assessment, toxicology is the main contributor as the toxicological approach is demanded by regulation. It traditionally assumes that a maximum safe dose can be determined from studies in experimental animals or sometimes humans and that division of this dose by appropriate safety factors defines the ‘safe’ intake for the human population. Epidemiology plays a minor role in risk assessment. Epidemiology describes associations between risk (or beneficial) factors and disease endpoints in humans. It has traditionally focussed more on relative than on absolute risks. Nutrition, as a science, uses a mixture of methodologies and is involved in estimating risks specifically for nutrients and other dietary factors. Benefit assessment for Food and Nutrition is newly developing in regulatory terms, but has been the subject of nutritional epidemiological research for a long time. Benefit assessment is working on concepts such as whether reduction of risk of disease should be termed a benefit, whether a benefit can be measured as a state rising above the average health and in which time frame (short or long term), and how broad its scope should be. In nutrition, current interest is in ‘optimal’ food and nutrient intake, implying knowledge of both intakes where risks occur and intakes where benefits occur. In this, there is a scientific development away from general population intakes towards an intake based on subgroups. In summary, the goal of risk assessment in food and nutrition is to reasonably guarantee absence of an effect (risk) whereas the goal of benefit assessment is to reasonably guarantee the presence of an effect (benefit). This distinction affects the assessment approach, the evaluation of the generated data and the way these can be used. In both risk and benefit assessment, good dose–response data, i.e. with relevant intake levels and suitable for the target population, are scarce. Better integration of all underlying disciplines and an approach focussed more on humans and continuous data is indicated.

Current approaches to bring benefit and risk assessment together mirror the traditional risk assessment paradigm of hazard identification, hazard characterization, exposure assessment and risk characterization. A tiered approach is advocated, as this allows for transparency, in-between consultancy with the benefit–risk manager and the possibility of an early stop in the assessment and thus increased efficiency. There is agreement about the importance of a good description of the benefit–risk question and the uncertainties in its assessment. Benefit–risk comparison can be qualitative and quantitative, with increasing data requirements. In a quantitative comparison, benefits and risks are expressed in a common currency. Severity of disease can be taken into account by attributing weights, e.g. using disability adjusted life years (DALY’s). These integrated measures need to be accompanied by at least (1) a description of the unintegrated benefits and risks on subgroups and (2) data uncertainties. In the quantification process, deterministic input may be substituted by probabilistic input; well-accepted methodology for probabilistic assessment is available.

Close communication, between and within benefit–risk assessors and managers, requires attention. In benefit–risk management some risk will have to be considered acceptable in order to achieve more benefits. Thus, current risk management will also need to consider a shift from striving for zero risk towards explicit weighing of risks and benefits in order to achieve an optimal outcome. The communication of benefits and risks to the public used to be separate, but the impact of combined benefit–risk messages is being explored.

In conclusion, benefit–risk assessment is developing steadily in the field of food and nutrition. General point of attention is the communication between fellow scientists, managers and the general public. General strengths are the ability to systematically and transparently show the current knowledge and its gaps and to provide what is likely the best answer to a question with a large potential impact on public health.

Benefit–risk analysis in Medicines (Luteijn et al., 2011)

Medicines can lead to significant health benefits. The health benefits come at the risk of potential adverse drug reactions. Since the thalidomide disaster in the early 1960s, increased regulatory attention has been placed in the benefit–risk profiles of medicines. This key-event has lead to not only demands on safety demonstration before registration of a medicine, but also to demands in regard to demonstration of efficacy, i.e. the effectiveness of a medicine under controlled conditions.

Benefit–risk assessment in medicine is highly regulated and has been developed for decennia. Benefit–risk assessment (and monitoring) takes place both in the pre-registration and the post-registration phase of a medicine. In the pre-registration phase, the candidate medicine goes through a process of phase I–III trials, involving populations of increasing size and different aims and designs as discussed in the state of the art paper. These clinical trials are conducted by the manufacturer and involve a considerable financial investment. Trials will only be continued if the manufacturer feels the drug stands a chance to successfully gain marketing authorization by sufficient proof of efficacy and safety. Data gathered by these clinical trials, reinforced by animal model data and possible post-marketing experience with similar compounds, will provide the safety and efficacy data for the marketing authorization procedure. The pre-marketing clinical trials have been criticized for being designed for fast approval instead of the generation of scientific knowledge. A number of mainly quantitative benefit–risk methods are employed during the pre marketing phase, including ‘number needed to treat’ and ‘number needed to harm’. Expert opinions play a big role in benefit–risk assessment of medicines, both pre-registration and post-registration. There is no standard protocol for analyzing the benefit–risk profile of a drug, after the manufacturer submits the clinical trial data, responsible authorities will take the evidence into account and form an expert opinion on the registration submission. Both the benefits (efficacy) and the risk (adverse drug reactions, ADRs) play a role in this expert opinion: larger benefits can justify larger risks. No consensus has been reached on a standardized methodology for benefit–risk assessment in medicine registration. The European Committee for Medicinal Products for Human Use recommends the use of multiple types of mainly qualitative, benefit–risk methodology and argues that use of quantitative methodology can lead to a misleading feeling of precision.

Pre-registration

The pre-registration clinical trials themselves suffer from a number of practical limitations; these include the small number of subjects in clinical trials, a restricted population in terms of age, gender and ethnicity, restricted co-medication and co-morbidity, a short duration of exposure and follow up and statistical problems with assessing multiple outcomes. These problems are acknowledged by the responsible authorities. Because the clinical trials take place in a controlled environment, situations of off-label use, drug–drug interactions and non-compliance will be limited to theoretical consideration. Therefore, clinical trials will provide information on the efficacy of a medicine, rather than effectiveness of a medicine. Despite the differences between efficacy and effectiveness, efficacy will provide an indication of effectiveness of a drug. It should be realized there is no solution for the majority of these problems. For example; it would be ethically unacceptable to conduct safety experiments in pregnant women. Experience in this population will be limited to animal models and post-registration data.

During the application process, a risk management program will be submitted along with the clinical trial data, outlining risk minimization and post marketing surveillance activities.

Post-registration

After registration, the benefit–risk profile of medicines will be monitored by post-marketing surveillance. Pre-marketing knowledge on the benefit–risk profile of a medicine will be limited for reasons mentioned above. Post-marketing surveillance is conducted by responsible authorities, marketing authorization holders and independent researchers in order to collect data on ADRs and monitor the effectiveness of existing risk management activities. In case a new ADR is discovered, responsible authorities can reassess the benefit risk profile forming a new expert opinion. Information discovered during post-marketing surveillance can lead to modification of marketing authorizations, risk management programs or even suspension of marketing authorizations in the case of serious ADRs. Many recent developments and initiatives are currently ongoing in post-marketing surveillance, many of them involving large databases to collect information on ADRs. The more statistical power, the better the investigators are able to detect ADRs. For this reason, an increasing amount of international cooperation is taking place in Europe. Other problems include different legislation between European countries.

A different type of benefit–risk assessment in the post-registration phase is Health Technology Assessment (HTA). In HTA, the health impact and economic impact of a new health technology are assessed using (economic) modelling techniques, usually in order to be included in public formularies. The main challenge of HTA is to assess the trade-offs between financial investment and health benefits. For this purpose, indexes such as QALY and DALY have been developed. The trade-off between financial investment and health benefits is perceived as controversial by many. Marketing authorizations have become less meaningful without reimbursement (after a positive HTA assessment) in many countries. The mandate and methodology of HTA agencies differ between countries.

The state of the art paper concluded that no ‘one size fits all’ approach is available for benefit–risk assessment in medicines. Choice of methodology depends on the context of the benefit–risk assessment, including indication, patient groups and the stage of the regulatory process. Also, use of multiple methodologies is encouraged due to each having its own specific strengths and weakness. Furthermore, improved cooperation between responsible authorities and HTA agencies can be of value in benefit–risk assessment.

Benefit–risk analysis in Food Microbiology (Magnússon et al., 2011)

Microorganisms, i.e. bacteria, fungi and viruses, are all constituents of our natural environment. The field of food microbiology concerns the multitude of microorganisms that inhabit and contaminate our foods. Food and nutrition are essential for sustaining human life. However, no food carries zero risk for microbiological hazards. The risk varies considerably depending on food types and matrices. Some foods have a higher risk than others of containing microbiological contaminants and pathogenic microorganisms that can be hazardous to our health and well being. Furthermore, consumer sub-groups can be variably susceptible to foodborne infections and intoxications; the elderly, young children and individuals with underlying diseases being more at risk.

Food microbiology is largely focused on food safety and limiting public exposure to harmful foodborne pathogens. However, the great majority of microorganisms are harmless to our health and many microorganisms are even important to various food production processes e.g. the making of cheese, wine, beer and bread. Microorganisms are used in various ways for the benefits of humans e.g. through advances in medical technology, biotechnology, agriculture and in food processing, to name a few. Although microorganisms can be seen as indirectly beneficial to human health through the above-mentioned activities, the human health consequences of microorganisms in foods are often either neutral or adverse. In food microbiology the reduction in human exposure to foodborne pathogens can commonly be regarded as the main public health benefit. Probiotic microorganisms and the activities of the gut microflora can be mentioned as an exception to this – the effect of probiotics can be seen as directly beneficial to human health. It must be noted, however, that to date all such probiotic health claims have been refuted by the European Food Safety Authority (EFSA, http://www.efsa.europa.eu/en/topics/topic/article13.htm); currently, there is lack of evidence for the direct beneficial effects as judged by EFSA’s criteria, but at the same time there is lack of evidence that beneficial effects do not exist.

Benefit–risk analysis is a relatively new and to-date largely undefined field of research within food microbiology. The benefit– risk analysis approach is concerned with issues affecting public health and improving public health management based on the balanced weighing of risks and benefits. From a food microbiological standpoint studies using methods that balance risks and/or risks and benefits using composite metrics are scarce. Published studies to date have mainly been intervention assessments or risk comparison studies that apply risk assessment criteria for comparing the level of two individual risk factors – with the purpose of identifying the most important health risks – commonly a chemical risk and the benefits of reduced microbiological risk. The criteria for the assessment of risks are well established within food microbiology (and are based on risk assessment criteria developed within toxicology), but at present the criteria for assessing positive health effects are not well defined.

A key issue in food microbiological benefit–risk analysis is how to address the assessment of benefits and the multidisciplinary discussion of how to aggregate risk and benefit estimates. The most straightforward approach to be used for benefit–risk analysis in food microbiology could be envisioned to follow the tiered approach for benefit–risk analysis formulated in the field of food and nutrition. Food microbiological benefit–risk analysis converges largely with that of food and nutrition. In addition, it often involves the evaluation of chemical as well as microbiological risks and benefits.

Disability adjusted life years (DALY’s) have widely been opted for as a metric of choice for ranking microbiological risk, including foodborne pathogens. It can be used as the single metric for assessing both microbiological and chemical hazards and could similarly be implemented for evaluating benefits. DALY’s have previously been used for assessing the global burden of disease, injury and risk factors and currently the global burden of foodborne disease is being estimated using DALY’s (http://www.who.int/foodsafety/foodborne_disease/ferg/en/index3.html). Based on this extensive groundwork, as food microbiology benefit–risk analysis goes, DALY’s are likely to be the common metric of choice, despite its shortcomings.

In conclusion, the field of benefit–risk analysis in food microbiology is in its infancy and the assessment criteria for benefits are not well defined. Reduced pathogen risk can be seen as the principal benefit regarding food microbiology while scientific data on direct microbial benefits are lacking.

Benefit–risk analysis in Environmental Health (Pohjola et al., 2011a)

The field of environmental health is very broad and involves significant physico-chemical, biological, technological and social complexity. Consequently there is no single state-of-the-art approach, but a multitude of approaches to assess environmental health risks and benefits have been developed for different purposes and contexts within the field. These approaches can be characterized e.g. as either regulatory or academic, depending on the context of development and application for the approach, or rather traditional or novel, depending on how strictly and narrowly the assessment scope and procedure are determined by the approach.

In comparison to the traditional and regulatory approaches the emphasis among the more novel and academic approaches is on (a) increased engagement between assessors, decision makers, and stakeholders, (b) more pragmatic problem-oriented framing of assessments, (c) integration of multiple benefits and risks from multiple domains, and (d) inclusion of values, alongside scientific facts, in explicit consideration in assessment. These tendencies can be considered as responses to the challenge of complexity within the field, but also as indications of the incapability of the currently established approaches to adequately address all aspects of this complexity. On the other hand, the all-embracing aims of the novel academic approaches may also lead to lack of clarity in comparison to the regulatory and traditional approaches, unless duly designed and implemented.

The key issues in benefit–risk analysis in environmental health are not so much related to the technical details of performing the analysis, but rather to (i) the level of integration, and (ii) the perspective to consider the relationship between assessment and the use of its outcomes. The level of integration can range from producing health risk estimates for single substances to aggregation, weighing, and comparison of multiple benefits, risks, impacts, and costs alongside explicit account of values of those concerned. Significant differences are also brought about by whether an ‘‘assessment push’’ or an ‘‘information need pull’’ perspective is adopted. The perspective largely defines what, how and why, issues are considered in an assessment.

In the ‘‘assessment push’’ perspective, the issue to be assessed is defined by those responsible for the assessment, and the focus of assessment is to produce an objective estimate of the risks, benefits, etc. according to certain defined principles and means, whatever the estimate may be used for. Approaches taking an assessment push perspective thus also predetermine the possible levels of integration in terms of e.g. what phenomena are considered, whether also benefits or costs are considered in addition to risks, and what means of aggregation or comparison are used. In the ‘‘information need pull’’ perspective the issue to be assessed, as well as the principles and means for its assessment, is formulated according to a specified practical need. The need thus determines the suitable format of the assessment outcome, which further determines how the assessment should be made. Therefore inclusion of all relevant issues, all levels of integration, and all means of aggregation and comparison are, at least in principle, available for use as required to serve the need. Naturally, most of the approaches to environmental health assessment fall somewhere in between these extremes by incorporating aspects of both push and pull. However it can be identified that the regulatory and the most traditional, simultaneously the currently most established, approaches clearly position themselves closer to the assessment push end of the continuum.

Challenges lie in the aggregation, weighing, and/or comparison of multiple benefits and risks. For example: the use of DALY’s, QALYs or euro’s as general aggregate measures, incommensurability of benefit estimates aiming for avoidance of false positives and risk estimates aiming for avoidance of false negatives, and taking account of perceived risks and benefits together with ‘‘scientifically assessed’’ risk and benefit estimates.

In conclusion, probably most of all commonly known methods for benefit–risk analysis are applied among the various different approaches to environmental health assessment, but there is no single view to dominate the whole broad field.

Benefit–risk analysis in Economics and Marketing–Finance (Kalogeras et al., 2011)

Risk is a key component of economic behaviour. All market participants (e.g. investors, producers, consumers) accept a certain level of risk as necessary to achieve certain benefits. There are many types of risk including price, production, financial, institutional, and individual human (e.g. health-related) risks. All these risks should be effectively managed in order to derive the utmost of benefits and avoid disruption and/or catastrophic economic consequences for the food industry and market participants’ wellbeing.

In (food) economics, finance and marketing-management literature, the utility concept (total satisfaction received from consuming a product/service) plays a crucial role in determining market participants’ benefit–risk trade-offs that drive economic phenomena. This utility is often derived from outcomes such as wealth, income, profit, selling price, among others. That is, the outcome domain is a monetary one. Yet, in behavioural economics, behavioural finance, economic psychology, marketing and consumer behaviour literature, market participants may also derive utility from non-monetary outcomes by exposing a combination of cognitive and affective behaviour.

The dominant paradigm in business economics on which decision makers (e.g. farmer, food manufacturer, retailer, consumer) rely in their benefit–risk trade-offs is the expected utility model. This model is concerned with choices among risky prospects. The goal of a decision maker is the maximization of his/her expected utility. In the expected utility framework, the shape of the utility function is assumed to reflect a decision maker’s risk preference. Therefore, the expected subjective utility function of any prospect reveals the individuals’ attitudes towards risk. There is a continuous stream of research on decision makers’ risk preferences in the fields of food economics and marketing–finance that employs expected utility models that are objective or normative, i.e. assumption and establishment of norms implying the rationality principle in economic behaviour of market-participants: maximization of their utility, by using time series and/or panel data for production, consumption, pricing levels of food products; and subjective, i.e. relaxing the rationality assumptions inherent in the normative models by using survey- and experimental-based data gathering instruments involving psychometric constructs or lotteries. Both theoretical and empirical research accounts show that decision makers can be simultaneously risk-seeking and riskaverse in different domains, implying that risk preference is context- specific.

In the context of agribusiness and food markets, concerns about food safety, quality, and nutrition have persistently been present at all levels of decision making (operational, tactical and strategic) by food producers, manufacturers, commodity traders, retailers, and consumers. However, business economic scholars are often confronted with conceptual and methodological challenges due to the unobserved and multidimensional nature of human decision making process. That is, the actual behaviour of market participants is not always consisted with the ‘‘true’’ level of risk that they face.

Recent research in management sciences and decision analysis argued that by decoupling the benefit–risk trade-offs of decision makers into separate dimensions a more robust conceptualization and prediction may be achieved. Specifically, market participants have two kinds of evaluation systems on which perceived and/or actual benefits of an investment or consumption object cognitively rely on: (a) utilitarian dimension of instrumentality and (b) a hedonic dimension. The first dimension refers to how useful or beneficial the investment or consumption action is. The second dimension of benefits refers to the experiential affect associated with the investment and consumption. These two dimensions are neither mutually exclusive nor need to be evaluative consistent. Similarly, risk behaviour may be decoupled into the separate dimension of risk attitude and risk perception. Risk attitude is formed by one’s predisposition to the content of the risk in a specific market situation and reflects a decision-maker’s interpretation of this risk content in a specific way, whereas risk perception refers to the likelihood of one’s exposure to the risk content. This decoupling approach may serve as the basis for studying the decision- making process of market participants regarding food safetyand nutrition-related issues, in the light of benefit–risk trade-offs. Yet, one may recognize the challenges for operationalising such a framework, adapt it to specific decision contexts, and accounting for its dynamics.

In conclusion, the study of market participants’ benefit–risk trade-offs in business economics rely on the utility concept. Although the dominant paradigm in economics is the expected utility model that has a normative nature, the behavioural study of market participants’ benefit–risk trade-offs emerges. Nowadays, there are various and different approaches and techniques to businesses economics to identify and evaluate the benefit–risk tradeoffs on institutional or individual market participants. Yet, there is no single view to dominate the whole discipline. The decoupling of benefit–risk behaviour into separate components that deal with both the utilitarian as well as hedonic aspects of benefits and risks may offer more robust conceptualizations and predictions for studying benefit–risk trade-offs in various highly uncertain decision contexts entailed in the agribusiness and food markets.

Benefit–risk analysis in Consumer Perception (Ueland et al., 2011)

Food and nutrition are central to the survival of human beings as well as to their well-being and quality of life. However, a ‘‘nutritionally perfect life’’ is not necessarily consistent with consumers’ feelings of how a perfect life should be which again has implications for what motivates consumers’ food choice. The inconsistencies are partly the result of consumers’ perceptions of benefits and risks with regard to food and nutrition and of the way consumers trade off between benefits and risks in order to maximize the outcome they prefer. Thus, by incorporating the study of consumers’ perception of benefits and risks in a food and nutrition context, possible outcomes of food and nutrition measures can be better understood.

For consumers, benefit perception of food is usually more important than risk perception. The benefits are particularly related to the hedonic perspective; food should taste good, be pleasurable and fulfil expectations to an enjoyable experience. Risks, on the other hand, are more often subject to conscious deliberations and external factors, such as available information, media coverage and personal interest that contribute to consumers’ risk perception.

Consumers’ perception of risks is associated with mortality and morbidity and goes along two main dimensions related to; the extent that the risk is unknown, and what are the consequences of the risk. Food risks are not perceived to be as severe as are for instance risks associated with firearms or airplanes. However, some foods, particularly those that score high on the unknown dimension, are perceived with trepidation by consumers. Conversely, foods that are perceived as risky are often foods that are unfamiliar or produced by novel technologies. Furthermore, foods that are (perceived to be) highly processed are considered to be less desirable and more risky, than foods perceived to have a low level of processing. The possibility to discern what the food product is made of, or what it is derived from, contributes to a feeling of safety and to lower risk perception among consumers.

There are ways to reduce perceived risk of foods for instance through familiarising the consumer with the food, or by adding characteristics that may be seen as benefits to the food product. Increasing healthiness and enhancing taste are factors that make consumers more willing to accept the product. Adding benefits to a product does not reduce the risk itself but reduces the consumers’ perception of the risk. Benefit and risk perception of foods are in many cases inversely correlated: when something is perceived as being highly beneficial, it is correspondingly perceived as having low risk. However, slightly different paths are used in the formation of these perceptions; benefit perception is based on heuristics and experience, while risk perception is largely the result of cognitive information processing.

Nutrition is one aspect belonging to food products that is normally not associated with hedonic benefits of foods. However, nutrition is accepted as an essential part of consumers’ life, and health attributes of foods are perceived as benefits when diet considerations are important for the consumers. Consumers easily perceive risks belonging to malnutrition, both related to overand under-consumption of nutrients, but consumers’ may choose not to pay attention to these risks.

In conclusion, in a food and nutrition setting it is important to understand which food attributes related to perceived and real benefits and risks that influence food choice, in order to provide for an optimal diet from both a health perspective as well as from a hedonic perspective.

Contemporary regulatory context for Food and Nutrition assessment and management

The EU Food Safety legislation (http://ec.europa.eu/food/food/foodlaw/index_en.htm)(EU, 2000) is built around high food safety standards, of which the final aim is to protect the health of the consumers and to reduce the risks connected to unsafe food (van der Meulen and van der Velde, 2008).

The development of the requirements is the result of stratified legislative measures, often approved by incidents (food safety crises consequent to foodborne diseases) rather than by a systematic legislative plan. Regulation EC/178/2002 is the General Food Law, containing general provisions useful to orientate the interpreter in understanding the mechanisms and procedures to be followed in order to reduce risks related to unsafe food. The general principles of food law may be considered the top of the ideal pyramid of a regulatory food control systems. Regulations and directives have been formulated within this frame.

The aim of EU food policy is to assure a high level of food safety, animal health, animal welfare and plant health within the European market. In this sense, the General Food Law constitutes the main reference point of the EU food legislation. It applies to all stages of the production, processing and distribution of food and also to feed produced for, or fed to, food producing animals. More in detail, the General Food Law establishes the principles of risk analysis in relation to food and establishes the structures and mechanisms for the scientific and technical evaluations which are undertaken by the European Food Safety Authority (EFSA). As an exception of the general tendency to regulate risks rather than benefits, it is worth mentioning the EFSA health claims procedure under Regulation (EC) No 1924/2006, which plays a relevant role in the regulation of the benefits. Nevertheless, also in this case, we may see that the final objective of regulating benefits turns into the legislative intention to prevent risks, both connected to the functioning of the market and to the consumers’ protection, if we consider that the general objective of the Regulation is to ensure the effective functioning of the internal market as regards nutrition and health claims whilst providing a high level of consumer protection (EC, 2006).

Food law, and in particular measures relating to food safety have to be based on scientific expertise. The EU has developed its own risk analysis principles in conformity with the International standards. Regulation EC/178/2002 establishes in EU law that the three phases of risk analysis (risk assessment, risk management and risk communication) provide the basis for food law as appropriate to the measure under consideration. Therefore, the General Food Law states that scientific assessment of risk must be undertaken in an independent, objective and transparent manner based on the best available science. Risk management is the process of weighing policy alternatives in the light of results of a risk assessment and, if required, selecting the appropriate actions necessary to prevent, reduce or eliminate the risk to ensure the high level of health protection determined as appropriate in the EU. In the risk management phase, the decision makers need to consider a range of information in addition to the scientific risk assessment. These include, for example, the feasibility of controlling a risk, the most effective risk reduction actions depending on the part of the food supply chain where the problem occurs, the practical arrangements needed, the socio-economic effects and the environmental impact. Regulation EC/178/2002 establishes the principle that risk management actions are not just based on a scientific assessment of risk but also take into consideration a wide range of other factors legitimate to the matter under consideration (see http://ec.europa.eu/food/food/foodlaw/principles/index_en.htm).

In sum, at a legislative level we may observe that the main objective is to regulate risks connected to unsafe food, rather than benefits and the balance between risks and benefits. Risk management is a procedure which involves legislative tools together with scientific expertise. The choice to regulate risks rather than benefits is deeply linked to the necessity to reduce the risks on the market by defining the tasks of the European Commission, the European Food Safety Authority (http://www.efsa.europa.eu) and the national competent authorities in charge to implement at local level the European provisions.

Commonalities and differences, and illustration in a case study

This section contains some of the characteristics that the different fields, described in the previous section, share in common and in which they differ with respect to benefit–risk analysis.

The general settings in which benefit–risk analyses within the different fields currently may take place are described in Table 1. The general characteristics of integrated assessment of benefits and risks within different fields are described in Table 2. In order to illustrate the commonalities and differences, a conceptual case example of replacing animal protein with environmentally more sustainable dietary protein is presented in Table 3. The case example described here is meant as an aid, to illustrate and characterize the different fields that form this paper. The attributes in the tables, according to which benefit–risk analysis within the different fields are described, are adapted from the framework applied for characterizing approaches to benefit–risk analysis in the field of environmental health in Pohjola et al. (2011a) and explained in Table 4.

In Section 3.1, general commonalities and differences are described, taking the main points from Tables 1 and 2. Issues arising from the illustrative case study in Table 3 are discussed in Section 3.2.

General commonalities and differences

The purpose of benefit–risk management is to arrive at the optimal decision, while accounting for all relevant issues. The purpose of benefit–risk assessment is to provide the science-based information on the integrated benefits and the risks to support in answering the benefit–risk management question, i.e. to contribute to evidence-based decision making. The focus of benefit–risk analysis in the different fields is

• Food and Nutrition: improving public health/preventing disease

by better food and nutrition and generating knowledge for food improvement or innovation and general understanding.

• Medicines: curing, slowing or preventing disease by means of medication and monitoring benefit–risk profiles of marketed medicinal products with or without its impact on budget.

• Food Microbiology: preventing foodborne disease caused by

micro-organisms and generating knowledge for microbiological product innovation.

• Environmental Health: preventing damage to health mediated

through the environment, possibly also reducing impact on economy, society and environment.

• Economics and Marketing–Finance: optimising public economic

policies, corporate investment and marketing strategies.

• Consumer Perception: stimulating good food choice by using

insights in consumers’ perceptions, attitudes and behaviour relating to a particular case and by increasing acceptance through information, increasing familiarity, reducing uncertainty, and product optimization.

The challenges of aggregating and weighing benefits and risks are shared by the different fields. Two issues coming up in this connection are the inclusion of multiple benefits and risks with different scopes, and the explicit inclusion of subjective information. Among the fields that are considered, assessments in Food and Nutrition, Food Microbiology, Medicines and Environmental Health focus predominantly at health/disease, mostly physical health/disease (though several approaches in Environmental Health are open to also include other domains). Quantitative weighing of benefits and risks via DALYs or QALYs has been performed in Food and Nutrition, Food Microbiology, Environmental Health and in post-marketing modelling studies for Medicines. Mostly this is done within strict and relatively narrow bounds, e.g. focusing on the health effects of food compounds. In Economics and Marketing–Finance as well as Consumer Perception, health is not the centre of attention. In the latter two, human perception and behaviour is an important topic of investigation, whereas the former four strive for more ‘objective’ health information. However, also there, the influence of perception and behaviour is acknowledged, at least to some degree, e.g. in the form of the placebo effect and compliance to prescriptions or advice. Qualitative comparison and use of expert judgment are part of all fields, but in differing degrees. For example, expert opinions/judgments in different phases have an important role in the progress of medicine benefit–risk analysis along the early stages of drug development. In Food and Nutrition, (expert) value statements are explicitly named only in comparison or combination of benefits and risks (e.g. qualitative comparison, and disability weights). Non-expert value judgments are increasingly taken into account particularly in Environmental Health.

Another notable issue relates to differences in the valuation of benefits and the acceptability of risks, both by consumers and managers. In Food and Nutrition and Food Microbiology, chemical, biochemical and microbiological risks are not accepted, i.e. food safety issues are minimised to such a low level that risks are virtually absent (see also Section 2.7). Especially Food Microbiology is illustrative of the important role of ‘risk’ in public health. In contrast, in many approaches to Environmental Health and in Medicines, some risk is accepted for a greater benefit. In Medicines, risk, in the form of adverse drug reactions, is accepted for the greater benefit of recovery or of alleviation of symptoms. Also, by observing the common everyday practices, some degree of risk coming from the environment in the form of traffic, energy production, radiation, disinfection, etc. can be considered as accepted in order to meet the needs of modern society. However, the perceptions of such risks may vary significantly among policy makers and the public, and the differing perceptions may not always be backed up with well-reasoned knowledge. Moreover, in Economics and Marketing–Finance and Consumer Perception, (high) risks can be accepted if the expected benefits are higher and at least some degree of risk is accepted as necessary to bring about benefits in general. Some differences with respect to the degree in which risk