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Meeting the challenges in the development of risk-benefit assessment of foods

April 2018
Trends in Food Science & Technology 76

DOI:10.1016/j.tifs.2018.04.004

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Authors:

Maarten Nauta

Statens Serum Institut

Sara M Pires

Technical University of Denmark

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Background Risk-benefit assessment (RBA) of foods aims to assess the combined negative and positive health effects associated with food intake. RBAs integrate chemical and microbiological risk assessment with risk and benefit assessment in nutrition. Scope and Approach Based on the past experiences and the methodological differences between the underlying research disciplines, this paper aims to describe the recent progress in RBAs, identifying the key challenges that need to be addressed for further development, and making suggestions for meeting these challenges. Key Findings and Conclusions Ten specific challenges are identified and discussed. They include the variety of different definitions and terminologies used in the underlying research disciplines, the differences between the “bottom-up” and the “top-down” approaches and the need for clear risk-benefit questions. The frequent lack of data and knowledge with their consequential uncertainties is considered, as well as the imbalance in the level of scientific evidence associated with health risks and benefits. The challenges that are consequential to the need of considering substitution issues are discussed, as are those related to the inclusion of microbiological hazards. Further challenges include the choice of the integrative health metrics and the potential scope of RBAs, which may go beyond the health effect. Finally, the need for more practical applications of RBA is stressed. Suggestions for meeting the identified challenges include an increased interdisciplinary consensus, reconsideration of methodological approaches and health metrics based on a categorisation of risk-benefit questions, and the performance of case studies to experience the feasibility of the proposed approaches.

The risk analysis framework with the elements risk assessment, risk management and risk communication. Adapted from WHO (2005).

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The elements of risk assessment as used in toxicology, microbiology and nutrition. Differences in the approach used in the three disciplines are explained in the text. Traditionally, the link between hazard identification and exposure assessment is not indicated in toxicology and nutrition, whereas it is essential in microbiology, where exposure depends on the microorganism of concern.

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Contents lists available at ScienceDirect

Trends in Food Science & Technology

journal homepage: www.elsevier.com/locate/tifs

Review

Meeting the challenges in the development of risk-beneﬁt assessment of

foods

Maarten J. Nauta

∗

, Rikke Andersen, Kirsten Pilegaard, Sara M. Pires, Gitte Ravn-Haren,

Inge Tetens, Morten Poulsen

Research Group for Risk-Beneﬁt, National Food Institute, Technical University of Denmark (DTU), Kemitorvet, 2800 Kgs. Lyngby, Denmark

ABSTRACT

Background: Risk-beneﬁt assessment (RBA) of foods aims to assess the combined negative and positive health

eﬀects associated with food intake. RBAs integrate chemical and microbiological risk assessment with risk and

beneﬁt assessment in nutrition.

Scope and Approach: Based on the past experiences and the methodological diﬀerences between the underlying

research disciplines, this paper aims to describe the recent progress in RBAs, identifying the key challenges that

need to be addressed for further development, and making suggestions for meeting these challenges.

Key Findings and Conclusions: Ten speciﬁc challenges are identiﬁed and discussed. They include the variety of

diﬀerent deﬁnitions and terminologies used in the underlying research disciplines, the diﬀerences between the

“bottom-up”and the “top-down”approaches and the need for clear risk-beneﬁt questions. The frequent lack of

data and knowledge with their consequential uncertainties is considered, as well as the imbalance in the level of

scientiﬁc evidence associated with health risks and beneﬁts. The challenges that are consequential to the need of

considering substitution issues are discussed, as are those related to the inclusion of microbiological hazards.

Further challenges include the choice of the integrative health metrics and the potential scope of RBAs, which

may go beyond the health eﬀect. Finally, the need for more practical applications of RBA is stressed. Suggestions

for meeting the identiﬁed challenges include an increased interdisciplinary consensus, reconsideration of

methodological approaches and health metrics based on a categorisation of risk-beneﬁt questions, and the

performance of case studies to experience the feasibility of the proposed approaches.

1. Introduction

Food is a basic requirement for life, providing the essential nutrients

and energy required for optimal health. However, food may also be

associated with adverse health eﬀects, because it may contain natural

toxins, hazardous chemical substances or pathogenic microorganisms

that can aﬀect health negatively. Additionally, it is possible that the

dietary intake of speciﬁc nutrients in foods is either too low or too high,

resulting in potential deﬁciencies or toxicity symptoms.

The diverse causes of these health eﬀects associated with food

consumption and the demand for advice on safe and healthy diets have

led to the development of diﬀerent research disciplines in food safety

and nutrition. The negative health impact of human exposure to che-

mical substances and pathogenic microorganisms through food is

evaluated in two separate disciplines, chemical and microbiological risk

assessment. Apart from that, both health risks and health beneﬁts as-

sociated with foods and diets have been studied through the discipline

of nutrition. However, in the past decade, the joint assessment of risks

and beneﬁts associated to hazardous agents, food compounds, nu-

trients, single foods and whole diets has been taken up, resulting in the

establishment of “risk-beneﬁt assessment”(RBA) as a new multi-

disciplinary and integrated scientiﬁc discipline (Boué, Guillou,

Antignac, Bizec, & Membré, 2015;Tijhuis et al., 2012;Verhagen et al.,

2012a).

With the overall aim of exploring how RBA can be further devel-

oped, this paper aims to describe the recent progress in RBAs and to

identify and discuss key challenges in RBA research. To clarify the

fundamentals of RBA and to provide a basic understanding of the

background of many of the challenges, the main concepts of the un-

derlying disciplines chemical risk assessment, microbiological risk as-

sessment and nutritional risk and beneﬁt assessment are explained.

Following that, the developments in RBA thus far are addressed. The

major part of the paper is devoted to a discussion of ten challenges, as

well as to suggestions for how they can be met. The conclusion

https://doi.org/10.1016/j.tifs.2018.04.004

Received 2 December 2016; Received in revised form 16 February 2018; Accepted 18 April 2018

∗

Corresponding author.

E-mail address: maana@food.dtu.dk (M.J. Nauta).

Trends in Food Science & Technology 76 (2018) 90–100

Available online 21 April 2018

summarizes the authors’vision on the future developments of the re-

search area.

1.1. Risk and beneﬁt assessment in food safety and nutrition

The use of risk assessments has traditionally been an integrated part

of a common risk analysis framework (Fig. 1), where risk assessment is

done by risk assessors who provide scientiﬁc advice to support decision

making by risk managers, such as food authorities or food producers, on

the potential risks associated with food consumption. Risk commu-

nication is an essential part of the risk analysis, both between risk as-

sessors and risk managers, and between assessors, managers and other

stakeholders (FAO/WHO, 2006a).

Risk assessment was ﬁrst formalised for chemicals by the estab-

lishment in 1980 of the International Programme on Chemical Safety

(IPCS), which proposed a scientiﬁcally based process including four

elements: hazard identiﬁcation, hazard characterization, exposure as-

sessment and risk characterization (Fig. 2). The ﬁrst step, hazard

identiﬁcation, involves the identiﬁcation of the inherent toxicological

properties of a chemical substance in the food that may aﬀect human

health adversely. Depending on the nature of the chemical substance,

the information on hazards may stem from in vitro studies (for example

on genotoxicity), experimental animal studies, and human data. The

next step, hazard characterization, involves dose-response evaluations

of the toxicological eﬀects of the chemical substance that are identiﬁed

in the previous step, including identiﬁcation of critical eﬀect levels such

as no observed adversary eﬀect level (NOAEL), lowest observed ad-

versary eﬀect level (LOAEL), or a benchmark dose (BMD) (IPCS, 2010).

These critical eﬀect levels are based on either acute or chronic eﬀects

and are usually determined on the basis of results obtained from animal

experiments. After applying uncertainty factors to account for diﬀer-

ences in sensitivity between species (e.g., animal to man) and within

the human population, the critical eﬀect levels are translated to health-

based guidance values such as acceptable daily intake (ADI), tolerable

daily intake (TDI) or acute reference dose (ARfD) (IPCS, 2010). In ex-

posure assessment of the chemical substance, the exposure from food is

estimated by use of accurate and representative data of relevant food

consumption and occurrence of chemical substances in the foods. The

last step, risk characterization, integrates the outcomes of the hazard

characterization and the exposure assessment, and the output is given

to the risk managers.

Microbiological risk assessment has mainly been used for bacterial

pathogens, but it has also been applied to viruses and parasites. It was

developed after chemical risk assessment was established and adopted

much of the terminology. However, the nature of microorganisms has

led to speciﬁc challenges, which resulted in some essential diﬀerences

in the deﬁnitions (see Section 2.1), as well as in the risk assessment

methodology (Lammerding, 2013).

First, the deﬁnition and identiﬁcation of the microbiological hazard

are complicated by the fact that microorganisms adapt and evolve over

time, so new strains can emerge with diﬀerent characteristics than

those that were originally described. Next, the dose-response relation

typically describes acute health eﬀects, with the probability of acute

illness being described as a function of the ingested dose in a single

meal. Due to the diﬀerences in responses between humans and animals,

data for microbiological dose-response models can usually not be de-

rived from animal experiments. As an alternative, human data are re-

quired, but these are not easily obtained. The use of biologically

plausible “single hit”models that assume that, with low probability, a

single bacterial cell can lead to illness, is a general practice in micro-

biological dose-response modelling (Haas, Rose, & Gerba, 2014;FAO/

WHO, 2003). Exposure assessment is complicated by the fact that living

organisms can multiply, and consequently, the occurrence of microbial

growth and inactivation imply that concentrations can change during

food processing and storage. Therefore, concentration data alone are

insuﬃcient and the ingested doses have to be estimated by means of

mathematical modelling in so called “process risk models”that apply

predictive models for growth and inactivation (FAO/WHO, 2008;

Zwietering & Nauta, 2007). Note that this implies that, in contrast to

chemicals, exposure depends on the growth and inactivation char-

acteristics of the microorganism of concern (Fig. 2). Critical limits for

the presence of microorganisms are generally not determined on the

basis of the hazard characterization only, so equivalents of NOAEL and

BMD as used in toxicology are not applied. Instead, risk-based micro-

biological targets such as food safety objective (FSO) are used, which

are derived from risk characterization, i.e., a combination of hazard

Fig. 1. The risk analysis framework with the elements risk assessment, risk

management and risk communication. Adapted from WHO (2005).

Fig. 2. The elements of risk assessment as used in toxicology, microbiology and

nutrition. Diﬀerences in the approach used in the three disciplines are ex-

plained in the text. Traditionally, the link between hazard identiﬁcation and

exposure assessment is not indicated in toxicology and nutrition, whereas it is

essential in microbiology, where exposure depends on the microorganism of

concern.

M.J. Nauta et al. Trends in Food Science & Technology 76 (2018) 90–100

characterization and exposure assessment (FAO/WHO, 2006b).

Risk assessment of essential nutrients follows the same principles as

chemical risk assessment, with the notion that essential nutrients have a

dual risk relationship with risks occurring at both the upper end (‘ex-

cess’) and lower end (‘deﬁciency’) of the intake range (NCM, 2014).

Another distinct feature is that data on adverse eﬀects in relation to

excessive or deﬁcient amounts of nutrients are often available from

human studies, which compared with chemical risk assessments

overall, may reduce the size of uncertainty factors applied. The toler-

able upper intake level (UL) is the maximum level of chronic daily

nutrient intake from all sources judged to be unlikely to pose a risk of

adverse health eﬀects to humans (EFSA, 2006) and thus includes an

uncertainty factor as in the case of chemicals. The lower threshold in-

take (LTI) is the level of intake below which, on the basis of current

knowledge, almost all individuals will be unable to maintain “metabolic

integrity”, according to the criterion chosen for each nutrient (EFSA,

2010b).

Consideration of speciﬁc nutrient intakes associated with adverse

health eﬀects above or below speciﬁc intake levels has received less

attention in the nutrition area compared with non-nutrients, such as

drugs, food additives, and pesticides (IOM, 2007). The concept of the

risk assessment of nutrients was stimulated by the IPCS in 2002 (IPCS,

2004), and by the Codex Alimentarius, FAO/WHO, EFSA and others

(FAO/WHO, 2006c;Aggett, 2010;Taylor & Yetleya, 2008). In addition,

the implementation of an organized nutritional risk assessment ap-

proach for scientiﬁc reviews has been stimulated by the increased use of

food supplements, fortiﬁed- and functional foods and subsequent re-

quests by regulatory agencies to identify upper levels of nutrient intake

(Taylor & Yetleya, 2008;Taylor, 2007). In 2010, EFSA published a

scientiﬁc opinion on the general principles for development and ap-

plication of dietary reference values (DRVs) (EFSA, 2010b), and other

DRV processes have followed the same risk assessment approach, in-

cluding the update of the Nordic Nutrition Recommendations (NCM,

2014).

Current approaches thus predict a threshold above which the nu-

trient intake is excessive, and another threshold below which the intake

is inadequate, while an intake range between these two boundaries can

be considered an ‘optimal’intake range within which the recommended

intake and the beneﬁtassessment is set (NCM, 2014). Nutritional

beneﬁt assessment may thus be considered as the intake range beyond

which there is a risk. Nutritional RBA can be broadened to not only

consider nutrients, but also to include any excess or deﬁcient intake of

foods, diets or energy.

One example of the application of beneﬁt analyses is the European

health claim regulation, which states that health claims should be

“substantiated by generally accepted scientiﬁc evidence and by taking

into account the totality of the available scientiﬁc data, and by

weighing the evidence”(EU Commission, 2006). The steps involved in

the assessment of health claims include identiﬁcation and character-

ization of the food or the food compound, deﬁnition of the eﬀect and

assessment of whether such an eﬀect can be considered beneﬁcial to

human health. Finally, the scientiﬁc substantiation for a beneﬁcial ef-

fect is assessed based on the totality of the current evidence between

the consumption of the food or the food compound and the claimed

eﬀect studied in the appropriate target group (EU Commission, 2006).

A comparison of the application of risk and beneﬁt assessment for

chemical substances, microorganisms and nutrients shows that, tradi-

tionally, risks are considered for all, but beneﬁts only in nutrition. An

essential diﬀerence between diﬀerent types of risk and beneﬁt assess-

ment is illustrated in Fig. 3. Typically, looking at both acute and chronic

adverse eﬀects, chemical and microbiological risk assessments in-

vestigate situations where exposure is to be considered “too high”. This

implies that the risk increases with higher doses, and threshold doses

may be derived as cut-oﬀpoints below which the intake is considered

safe, or the associated risk is considered acceptable (Barlow et al.,

2015). In contrast, within nutrition, both the situation where there is a

risk of nutritional deﬁciency and the situation where there is a risk of

nutrient intoxication are relevant, creating a “window of beneﬁt”

(Palou, Pico, & Keijer, 2009;Tijhuis et al., 2012)). Interestingly, re-

search in situations where the intake is too high (above the upper intake

level (UL)) is commonly referred to as toxicology, whereas research

considering beneﬁcial intake or too low intake, is part of nutrition.

1.2. The development of risk-beneﬁt assessment

Although independent risk and beneﬁt assessments have proven to

be useful for decision support in food safety and nutrition, their results

may be too much focused on one hazard, one food compound or one

health eﬀect. When establishing guidelines and advice on food con-

sumption, nutrient intake and diet choices, there is a need for an

overarching approach, in which all of the relevant health risks and

beneﬁts are included and compared. This need for RBAs has been

identiﬁed earlier in several publications (EFSA, 2007;EFSA, 2010a;

Renwick et al., 2004) and led to the development of RBA of foods as a

new research discipline. An RBA is multidisciplinary by nature, and

may require expertise from not only toxicologists, microbiologists, and

nutritionists, but also from epidemiologists, chemists, librarians, sta-

tisticians, and medical scientists. As proposed in the EU-funded project

BRAFO (Beneﬁt-Risk Analysis of FOods) (Boobis et al., 2013), it is

common to use the risk analysis and risk assessment frameworks

(Figs. 1 and 2) as the basis for the RBA methodology by applying the

established concepts to both risks and beneﬁts. A recent extensive re-

view of studies related to the combined RBA of foods, nutrients and

compounds shows that the majority of published studies have been

related to ﬁsh consumption where the nutritional beneﬁcial eﬀects are

compared with the adverse eﬀects from chemicals (Boué et al., 2015).

This RBA of ﬁsh (e.g. (Hoekstra, Hart et al., 2013)) is an example of an

RBA case where the content of polyunsaturated fatty acids, and in

particular docosahexaenoic (DHA), and eicosapentaenoic fatty acids

(EPA), recognized for their health beneﬁts, is counterbalanced by the

content of pollutants such as methylmercury and dioxins, known to

potentially induce adverse health eﬀects. There is also an example of

microbiological aspects being added to an RBA of ﬁsh (Berjia,

Andersen, Hoekstra, Poulsen, & Nauta, 2012).

Several European projects have been conducted in which methods

and modelling frameworks were developed, leading to considerable

progress in the risk-beneﬁt area (Boobis et al., 2013;Hart et al., 2013;

Hoekstra et al., 2012;Verhagen et al., 2012a). Among others, the

BRAFO project and EFSA developed the ”tiered approach”to be used as

a general framework for RBA

(Fransen et al., 2010;Hoekstra et al.,

2012). The basis is that a number of tiers have to be evaluated before

making a decision on the required steps to be taken in the RBA. This

approach proposes that a qualitative assessment is suﬃcient if data are

scarce or there is clear evidence that risks outweigh the beneﬁts (or vice

versa). If the balance between beneﬁts and risks is unclear, the as-

sessment has to be performed at a higher tier, including quantitative

assessment. As part of the BRAFO project, a number of relevant risk-

beneﬁt studies that illustrate the usefulness of a tiered approach for

RBAs have been performed (Hoekstra et al., 2008;Schütte et al., 2012;

Verhagen et al., 2012b;Watzl et al., 2012). A speciﬁc software tool,

QALIBRA, has been developed to facilitate the performance of quanti-

tative assessments in the ﬁnal tier (Hart et al., 2013;Hoekstra, Fransen

et al., 2013).

2. Challenges in risk-beneﬁt assessment

Although signiﬁcant progress has been made in the development of

Within the BRAFO project, the term beneﬁt-risk assessment was preferred over risk-

beneﬁt. For consistency we consequently use risk-beneﬁt assessment (RBA) throughout

this paper.

M.J. Nauta et al. Trends in Food Science & Technology 76 (2018) 90–100

methods and terminology in RBA, several challenges remain. Some of

these challenges relate to the diﬀerences between the underlying re-

search disciplines, which have diﬀerent use of terminology and dif-

ferent approaches for the assessment of health eﬀects related to the

consumption of food. Other challenges relate to the speciﬁc objective of

RBAs, the scarcity of the required data, or the complexity of the char-

acterization of health eﬀects. Below, we provide a description of ten

major challenges that were identiﬁed during the course of working with

RBAs, with explanations of the challenges and discussion on the way

forward for meeting them in the future.

2.1. Deﬁnitions

The diﬀerent approaches used in the disciplines contributing to RBA

(Section 1.1) apply diﬀerent terminology or may apply the same ter-

minology in a diﬀerent way. Dissimilar deﬁnitions can lead to confusion

and lack of understanding of the risk-beneﬁt question (Section 2.3). As

an example, the central concept of ”hazard”is deﬁned diﬀerently in

various contexts. Published deﬁnitions of hazard include “inherent

property of an agent or situation having the potential to cause adverse

eﬀects when an organism, system, or (sub)population is exposed to that

agent”(IPCS, 2004), ”the potential of a risk source to cause an adverse

eﬀect(s)/event(s)”(Renwick et al., 2003) and ”a biological, chemical or

physical agent in, or condition of, food with the potential to cause an

adverse health eﬀect”(CAC, 2011, p. 112). In the latter deﬁnition, the

hazard is the agent (or risk source, that is the pathogen, chemical

substance or food compound) and in the others it is an inherent property

or the potential of this agent. Due to this diﬀerence in deﬁnitions, the

hazard is usually synonymous to the pathogen(s) of concern in micro-

biological risk assessment, whereas it usually is the potential health

eﬀect caused by the chemical substance or food compound in chemical

risk assessment and nutrition (Barlow et al., 2015).

Similarly, there are diﬀerent deﬁnitions of ”risk”, for example ”the

probability of an adverse eﬀect in an organism, system, or (sub)popu-

lation in reaction to exposure to an agent”(EFSA, 2010a;IPCS, 2004),

or ”a function of the probability of an adverse health eﬀect and the

severity of that eﬀect, consequential to a hazard(s) in food”(CAC,

2011). So in one deﬁnition the risk is a probability, in the other, it is a

combination of probability and severity.

When mirroring risk assessment to beneﬁt assessment, the beneﬁtis

deﬁned at a level comparable to both the hazard and the risk (Boobis

et al., 2013;EFSA, 2006), so ”beneﬁt”is both the counterpart of ”ha-

zard”and the counterpart of ”risk”. Hence, the term ”beneﬁt”can be

used for anything between the agent causing the health eﬀect and the

probability and magnitude of that eﬀect. Moreover, when used as

equivalent of ”risk”, the beneﬁt is not necessarily interpreted as the

probability of a positive eﬀect, but commonly as the decrease in the

probability of an adverse health eﬀect. This wide interpretation of the

one of the central concepts in RBA can be considered confusing.

The present deﬁnitions can be well understood in a historical

perspective, given that RBA has evolved from a variety of disciplines.

However, for further development, the discipline ”risk-beneﬁt assess-

ment of foods”needs a clearer set of deﬁnitions and harmonized ter-

minology that is comprehensible for all those involved. To accom-

modate the fact that some agents or food compounds (i.e. “hazards”of

“beneﬁts”) can be both a source of positive and negative health eﬀect

depending on the exposure (Fig. 3), Boué et al. (2015) propose to use

the term ”health eﬀect contributing factor”(HECF) for ”the agent able

to cause an adverse or positive health eﬀect in the case of exposure”.

This is a useful ﬁrst step in the reconsideration of the terminology used

in RBA. Consensus within the international research community is re-

quired for clariﬁcation and harmonization purposes and deﬁnitely

when it would be used for regulatory purposes. Obtaining such a con-

sensus is a process that should be led by international authorities, and

should include representatives of all relevant disciplines involved in

RBA.

2.2. Bottom-up versus top-down approach

In this paper, we distinguish between two overall approaches to

assess health eﬀects in RBA and refer to them as “bottom-up”and “top-

down”. This terminology is derived from studies in microbiological food

safety aimed at ranking microbiological food risks (Cassini et al., 2016;

EFSA, 2015). The two approaches are characterised by their diﬀerent

starting point. The typical risk assessment approach, which starts with

the hazard identiﬁcation for the food product or its ingredients and

ﬁnishes with the human health outcome obtained after combining the

exposure assessment with a dose-response model (Fig. 2), is referred to

as the bottom-up approach. The alternative top-down approach starts

with the adverse (or beneﬁcial) health outcomes as obtained from

human observational studies, i.e., incidence data and identiﬁed risk

factors. These are then traced back to the food sources that caused the

disease of concern (or beneﬁt of desire), thus linking the health eﬀect to

the food product.

A similar distinction in approaches can be made in nutritional and

chemical risk assessment. The usual risk assessment approach (i.e.,

bottom –up) is targeted at intake of speciﬁc nutrients or food com-

pounds, and the dose-response relation is typically derived from animal

experimental data. The alternative top-down approach is an approach

where relative risk estimates from human observational studies are

used and linked to foods or food compounds that are identiﬁed as risk

factors. In the review of the BRAFO project, Boobis et al. (2013) identify

these two approaches as one based on experimental animal data

(bottom-up) and one based on human observational studies (top-down).

We prefer the bottom-up and top-down terminology as it is more gen-

eric and can also be applied for microbiological risk assessment, which

does not apply animal data.

Hence, with the bottom-up approach, the assessment starts with the

food product, food compound or contaminant, followed by an exposure

assessment and a dose-response model used for the risk-beneﬁt

Fig. 3. A comparison of approaches for hazard

characterization used in toxicology and microbiology

(left) and nutrition (right). In toxicology and micro-

biology, the risk increases with the dose; beneﬁts are

not deﬁned. In nutrition, intake of a food compound

can be too low or too high; intake between these

levels (“the window of beneﬁt”) is considered bene-

ﬁcial for health. X: Dose with critical response as

used in chemical risk assessment (e.g., LOAEL or

BMD); no equivalent metric exists in microbiological

risk assessment. LTI: Lower threshold intake, intake

below this level represents a deﬁciency; UL: Upper

intake level, intake above this level could give a toxic

eﬀect.

M.J. Nauta et al. Trends in Food Science & Technology 76 (2018) 90–100

characterization. An advantage of this approach is a direct causal link

between intake of the food product or food compound (or contaminant)

of concern and the associated health eﬀect. A disadvantage is that there

may be a large uncertainty attending the exposure assessment and

(especially) the dose-response.

With a top-down approach, the starting point of the analysis is the

incidence of a health outcome in the consumer. Typically, data from

epidemiological studies (case-control studies, cohort studies, rando-

mized controlled trials) are used to associate human health outcomes

with risk factors that are deﬁned in terms of food consumption, al-

lowing for the estimation of metrics such as the odds ratio or the re-

lative risk. These measures of association are then combined with po-

pulation statistics and incidence data to estimate the actual health risks

in the population. The relative risks may also be used to construct a

dose-response relation, where the relative risk is a function of the intake

as speciﬁed in the underlying study. The strength of human observa-

tional studies is that they are based on actual health eﬀects, measured

in speciﬁed populations. Weaknesses are that the observed associations

are not a proof of causation, that the studied population may not be

representative for the population group of interest and that many data

are required if the health eﬀect of interest is small. For microbial pa-

thogens, a top-down approach can be used to estimate the number of

cases of disease caused by a pathogen due to its presence in a speciﬁc

food, a method referred to as “source attribution”(Pires et al., 2009).

Here incidence data on a speciﬁc health outcome (e.g., gastroenteritis

caused by salmonellosis) is traced back to a speciﬁc food source (e.g.,

chicken meat) by the use of subtyping information of isolates of the

pathogen in human cases and food sources.

Generally, within RBA, it is necessary to use diﬀerent approaches

for diﬀerent health eﬀects of food compounds or contaminants. For

example, in the studies on ﬁsh of (Berjia et al., 2012;Hoekstra, Hart

et al., 2013)(Fig. 4), the eﬀects on coronary heart disease, stroke and

neurological development of children (IQ) are derived from top-down

approaches, but those related to exposure to dioxins and Listeria

monocytogenes are derived from bottom-up approaches. The reason for

the application of these diﬀerent approaches is obviously the avail-

ability of data, which in turn is related to the feasibility of acquiring the

requested data and also the quality of the studies providing the data.

Still, if diﬀerent approaches are used to obtain diﬀerent heath eﬀect

estimates in the same RBA, it may be hard to compare them. Not only

can there be a diﬀerence in the known bias associated with the ap-

proach (such as a potential to overestimate the risk obtained from dose-

response models derived from animal experiments), but also the nature

of the uncertainties associated with the assumptions of the approaches

will be diﬀerent (Section 2.5).

Studies that combined and compared bottom-up and top-down ap-

proaches may help clarify how the two methods can be integrated in

RBA. For example, Bouwknegt, Knol, van der Sluijs, and Evers (2014)

compared the approaches in a case study on Campylobacter in the

Netherlands and identiﬁed the diﬀerences in the underlying un-

certainties. They found that the diﬀerence in the point estimates of the

risks as found by the diﬀerent approaches can be large, but they still

have overlapping uncertainty intervals. This implies that one cannot a

priori conclude that one approach is better than the other. It is ad-

visable to aim for evidence synthesis by using an approach that takes

advantage of all available data and combines bottom-up and top-down

approaches. One option for evaluating such a combined approach is the

performance of simulation studies where the expected results of a hy-

pothetical epidemiological study are investigated on the basis of a risk

assessment.

2.3. The risk-beneﬁt question

The crucial initial step of an RBA is the deﬁnition of the risk-beneﬁt

question (Hoekstra et al., 2008) or problem deﬁnition (Boobis et al.,

2013;Boué et al., 2015;EFSA, 2010a). The risk-beneﬁt question is

generally a comparison between two, or a series of, choices, alternative

policies or courses of action, described in the form of scenarios (Boobis

et al., 2013). In these scenarios, both positive and negative health ef-

fects have to be taken into consideration. When a series of scenarios is

compared, the risk-beneﬁt question can be used to identify the op-

timum intake (Berjia et al., 2014). An aim of the risk-beneﬁt question is

to specify the RBA-task in such a way that it is feasible and will provide

useful results. For example, an RBA of ﬁsh should indicate what sort of

ﬁsh (e.g., lean/fatty, farmed/wild), target population group, and in

general any other constraint that could narrow the risk-beneﬁt ques-

tion. In the end, the level of speciﬁcation of the question will also de-

pend on the data available.

As a variety of risk-beneﬁt questions can be asked, it can be helpful

to categorise them and to identify speciﬁc approaches that can be used

to answer these diﬀerent categories of questions. Here, one type of

categorisation is the level of aggregation: the risk-beneﬁt question can

be targeted at a food compound level (a nutrient, a chemical or mi-

crobiological contaminant), a food product level (e.g., ﬁsh) or a diet

level (Hoekstra et al., 2008).

When the risk-beneﬁt question is targeted at the food compound

level, it should be a compound that is associated with both positive and

negative health eﬀects, e.g., a (micro-) nutrient. Examples for RBAs

directed at the food compound are those for folic acid (Hoekstra et al.,

2008)and vitamin D (Berjia et al., 2014)(Fig. 4). The choice between a

bottom-up or top-down approach will depend on whether the health

eﬀects associated with food compounds are obtained from animal ex-

periments or human observational studies. To assess the total intake of

the food compound, it will be necessary to consider the intake of all

relevant foods and food products in the diet that contain it, and the

concentrations of the compound in these foods and food products have

to be known. As this can be rather complicated, one can choose a risk-

beneﬁt question that only considers a diﬀerence in intake or con-

centration in one or a few food products, making some assumptions for

the background diet.

When the risk-beneﬁt question considers a food product, the posi-

tive and negative health eﬀects can be associated with diﬀerent food

compounds or contaminants that it contains. Typical examples of RBAs

directed at this level of aggregation are those performed for ﬁsh (Berjia

et al., 2012;Hoekstra, Hart et al., 2013,Fig. 4.) The health eﬀects of the

intake of the food product may be directly available from epidemiolo-

gical data or a human trial study, allowing the use of a top-down ap-

proach. Relative risk estimates can inform about the health impact of

one intake scenario compared with another. Alternatively, a bottom-up

approach may be used where all relevant food compounds (and con-

taminants) in the food product have to be identiﬁed and comprised in

the RBA to assure that the health eﬀects of interest are included. In that

case, a selection of relevant food compounds and contaminants needs to

be made based on the associated levels of evidence and the precise risk-

beneﬁt question. However, because in some cases only exposure

through the selected food product is considered, and not the total ex-

posure from all food products containing the compounds, it is diﬃcult

to use a bottom-up approach with a dose-response relation for each

compound.

When considering a whole diet, the bottom-up RBA approach will

usually not be feasible, unless the risk-beneﬁt question is clearly de-

limited: the number of food compounds (and contaminants) and their

combined intakes easily get too large for a complete exposure assess-

ment and hazard characterization. However, a top-down approach

using studies on human consumption may be possible if the appropriate

data are available, for example from a dietary intervention study. Van

Kreyl, Knaap, & Van Raaij, 2006, performed a study to analyse the

health eﬀects of the current diet in the Netherlands that may be re-

garded as an RBA of diets, but otherwise, to our knowledge, no formal

RBAs of whole diets have been performed so far.

In each of these three categories of risk-beneﬁt questions, the op-

tions for inclusion and exclusion of food compounds and contaminants,

M.J. Nauta et al. Trends in Food Science & Technology 76 (2018) 90–100

food products and health eﬀects are large. To clarify the selected ele-

ments in the risk-beneﬁt question, we propose the use of schematic

framing of the risk-beneﬁt question, as exempliﬁed in Fig. 4 for four

published risk-beneﬁt studies for food compounds or food products. A

scheme like this is broadly applicable and may oﬀer a transparent way

to identify diﬀerent types of risk-beneﬁt questions and clarify how the

risk-beneﬁt question is addressed. In the case of an RBA of a whole diet,

the scheme would be pretty complex, which stresses the diﬃculty of

doing an RBA of a whole diet.

2.4. Lack of data and knowledge and the consequential uncertainties

The data needs for an RBA are large and diverse. RBAs frequently

face data gaps and lack of knowledge, such as lack of human data, in-

formation on dose-response and intake levels for speciﬁc population

groups. These challenges are also faced in other modelling exercises

(such as many risk assessments), and need to be addressed by doc-

umentation and discussion of the assumptions made. A consequence of

limited data and lack of knowledge is that the uncertainty related to the

assessment may be large. Yet, characterising this uncertainty is crucial

in the risk-beneﬁt characterization.

As part of the QALIBRA project, Hart et al., 2013, provided an

overview and discussion on the importance and challenges related to

uncertainty in RBA and described strategies to deal with uncertainty.

The QALIBRA software tool developed in the project allows the user to

perform stochastic RBA and, as part of that, analyse uncertainty, either

by quantitative methods or by qualitative scenario analyses. This has

been an important step forward for the analysis of uncertainty within

RBAs.

Still, as previously identiﬁed by Boobis et al., 2013, and others,

there are diﬀerent areas within RBAs where lacking data creates a

major challenge. An important area is dose-response modelling. For

chemical substances, the dose-response relations are usually derived

from animal experimental data, where a set of assumptions is needed to

establish a threshold that can be applied for human consumers. As the

objective of these dose-response relations in animals is often to identify

potentially dangerous doses and to set safe health-based guidance va-

lues such as the ADI or TDI, the assumptions may tend to overestimate

the true human health risks. Yet, for RBAs, it is important to derive the

magnitude of the positive and negative health eﬀects in the same way

and therefore one needs the best possible estimate of the likelihood of

the health eﬀect from a dose-response relationship, not the “worst case”

value. For chemical dose-response relationships, this means that the use

of BMD models may be preferred over NOAELs and LOAELs, and that

the uncertainty factors used to translate animal data to human guidance

values may not be appropriate if the dose-response relationship is to be

applied in RBAs.

The uncertainty attending the dose-response relations for microbial

pathogens is also large. These dose-response relations are usually based

on human volunteer studies or outbreak data, which means they are

based on limited data sets, for speciﬁc strains and speciﬁc population

groups, and generalised thereafter. Dose-response relations based on

studies with healthy young volunteers may be expected to under-

estimate the risk, whereas those derived from outbreaks (with more

Fig. 4. Examples of risk-beneﬁt frames where the level of aggregation is the food product (above) or the food compound (below). The ﬁrst two examples represent

elements of the studies from Hoekstra, Hart et al. (2013), and Berjia et al., 2012, and illustrate how an RBA of a food product may include several food compounds

and contaminants, which each can have several health eﬀects (either negative or positive, indicated by + and -). Alternatively, eﬀects can be directly linked to the

intake of the food products (i.e., CHD and stroke). The other two examples are derived from Berjia et al., 2014, and Hoekstra et al., 2008, and illustrate how an RBA of

a food compound can include several health eﬀects and several food products, or even other sources of exposure. Note that Berjia et al., 2014, does not speciﬁcally

study the sources of vitamin D and Hoekstra et al., 2008, only considers scenarios involving fortiﬁed bread.

M.J. Nauta et al. Trends in Food Science & Technology 76 (2018) 90–100

virulent strains) may overestimate the risk. Further, it is known that

immunity plays an important role and may lead to overestimation of

the risk, but it is diﬃcult to include this in the modelling (Havelaar &

Swart, 2014).

Another uncertain element of the dose-response modelling is the

long-term eﬀect of exposure, which is speciﬁcally relevant for chemical

substances. An acute eﬀect is the direct consequence of in individual

ingested dose and therefore relatively easy to describe in dose-response

model. For long-term eﬀects, however, it is much harder to identify

how diﬀerent doses accumulate into health eﬀects. The use of physio-

logically-based pharmacokinetic (PBPK) models (Boobis et al., 2013;

Zeilmaker et al., 2013) can be useful, but these models still need further

development.

If the dose-response modelling is based on relative risk estimates

obtained from human observational studies, uncertainties may be large

as well. Some important issues are, for example, the uncertainty re-

garding the causality of observed associations between risk factor and

eﬀect and the representativeness of the data. To account for the un-

certainties, top-down approaches (using this type of eﬀect modelling)

and bottom-up approaches (using the other dose-response relations)

may be combined in a comparative analysis (Section 2.2).

Uncertainties are an inevitable intrinsic element of science, risk

assessment and RBAs, and it is of utmost importance that they are not

ignored. A challenge here is that, as in risk assessment, it is not pri-

marily the objective of an RBA to assure that the uncertainty is small

enough (as aiming for a p-value smaller than 0.05), but to indicate how

large the uncertainty actually is (Nauta, 2007). One should deal with

the identiﬁed uncertainties by explicitly addressing and characterizing

them in the assessment and by clearly communicating them to all sta-

keholders. By framing the risk-beneﬁt question (Fig. 4) and addressing

the required data, RBA models can be important in identifying the most

important data gaps and the crucial lack of knowledge. Thus, they can

guide future data generation and research. Setting the future research

agenda based on the most important sources of uncertainty can there-

fore be one of the key outputs of an RBA.

2.5. The imbalance in level of scientiﬁc evidence

The level of scientiﬁc evidence needed for identifying negative and/

or positive health eﬀects of a food compound, food or diet is not con-

sistent (Boobis et al., 2013), because the presence of beneﬁts and the

absence of risks need to be guaranteed (Hoekstra, Hart et al., 2013;

Tijhuis et al., 2012). In the case of health claims, a nutritional beneﬁt

needs to be scientiﬁcally substantiated with convincing evidence of the

cause and eﬀect relationship, before it can be accepted according to the

current EU regulation (Section 1.1). At the other hand, in the case of

setting dietary guidelines, a nutritional beneﬁt of a food or food group

may only need to be scientiﬁcally substantiated at the level of probable

likelihood of an association (Kromhout, Spaaij, de Goede, &

Weggemans, 2016;Tetens et al., 2013;WHO, 2003). Finally, the level

of scientiﬁc evidence needed for identifying risks or negative health

eﬀects may be small, as only an indication of a risk is suﬃcient for the

scientiﬁc substantiation.

Due to this discrepancy in the level of scientiﬁc evidence needed for

considering a food compound or contaminant as a “hazard”or a

“beneﬁt”, risks are more likely to be included in an RBA than beneﬁts,

thus leading to a potential bias in the RBA (Boobis et al., 2013;

Hoekstra, Hart et al., 2013;Tijhuis et al., 2012). Another consequence

of this discrepancy is that diﬀerent types and levels of uncertainty will

be associated to the risk assessment on the one hand and the beneﬁt

assessments on the other, which complicates the characterization of the

combined RBA even further (Section 2.4).

The imbalance in the required level of scientiﬁc evidence for risks

and beneﬁts demands a paradigm shift from the RBA as a sum of risk

and beneﬁt assessment to the RBA as a well-integrated risk-beneﬁt as-

sessment. Such a well-integrated RBA deals not so much with studying a

hypothesis about the presence or absence of a health eﬀect associated

with the intake of a (certain amount of) food product or food compound

or contaminant, but predominantly with the size of the health eﬀects.

Even though the strength of evidence for the presence of a health eﬀect

is strongly correlated to the size of the eﬀect, these are not the same

thing. Stochastic modelling techniques, which include quantiﬁcation of

uncertainty and variability, allow an evaluation of potential health ef-

fects, even if the eﬀects themselves are not statistically signiﬁcant. In

doing so, it may be possible to study how the estimated size of the

eﬀect, and some alternative scenarios about these eﬀects, may impact

public health. From this, one might conclude that the risk or beneﬁtis

not very large, even if the evidence would be convincing, or the op-

posite, that a risk or beneﬁt may be large, even if the level of evidence is

low. Findings like this can indicate crucial data gaps (Section 2.4) and

may, in an objective way, help identify where further research is

needed.

2.6. Substitution

In general, an RBA compares the health eﬀects of two or more in-

take scenarios, deﬁned as speciﬁed changes in the amount or type of

food consumed. As a side eﬀect, these speciﬁed changes in intake may

also imply a change in the intake of other food products to compensate

for the part of the diet that is deleted or added. So far, however, such

“substitution”is rarely included in an RBA. The risks and beneﬁts of

increasing ﬁsh intake are for example frequently studied, but the re-

lated decrease in the intake of one or more other foods and the con-

sequential health eﬀects of that decrease are not included in the as-

sessment (Berjia et al., 2012;Hoekstra, Hart et al., 2013). Ideally, the

risks and beneﬁts of the change in intake in these other foods are in-

cluded in the comparison of intake scenarios, but this severely com-

plicates the RBA because it extends the list of risks and beneﬁts to be

included in the assessment. A complicating factor in this context is also

that this substitution in terms of alternative amounts and types of food

eaten may vary among individuals, adding even more to the complexity

of the RBA.

Alternatively, it can be that substitution is the speciﬁc purpose of

the RBA, as for example in the case of food fortiﬁcation, when a non-

fortiﬁed food is replaced by a fortiﬁed food, and substitution is an in-

evitable part of the scenarios investigated (Hoekstra et al., 2008).

Likewise, substitution has been investigated in an RBA when added

sugar is substituted by artiﬁcial sweeteners (Hendriksen, Tijhuis,

Fransen, Verhagen, & Hoekstra, 2011;Husøy et al., 2008;Verhagen

et al., 2012b). In the ﬁrst case, no additional precautions need to be

taken, as the fortiﬁed and non-fortiﬁed diets are similar except for the

content of the speciﬁc nutrient. In the sugar-artiﬁcial sweetener case,

the substitution leads to non-isocaloric diets and this may need to be

addressed because it implies that the diet may change in more aspects

than just the intended substitution.

To meet this challenge, it is a prerequisite that substitution is ac-

knowledged in the RBA, either by speciﬁcally addressing it in the intake

scenarios that are analysed, or by referring to it in the discussion of the

assumptions and in the uncertainty characterization. As simpliﬁed

substitution scenarios, one can consider replacements in the same food

groups (e.g. meat and ﬁsh) and isocaloric alternatives (to make sure the

energy intake stays similar). Next, the impact of substitution can be

analysed in separate scenarios, where diﬀerent options for substitution

are compared.

2.7. The use of quantitative metrics

Within the tiered approach for RBA (Fransen et al., 2010;Hoekstra

et al., 2012), a qualitative approach can be suﬃcient if it is clear that

the risks dominate the beneﬁts or vice versa. If, alternatively, a quan-

titative approach is applied, the use of one common integrated health

metric is needed to combine diﬀerent positive and negative health

M.J. Nauta et al. Trends in Food Science & Technology 76 (2018) 90–100

eﬀects in an RBA and to compare diﬀerent health eﬀects within and

between assessments. The quantitative metric that is used most in

published RBAs of foods is the disability adjusted life years (DALY). The

DALY is a measure that indicates how many healthy years of life are lost

due to premature death or due to decreased quality of life associated

with a disease or hazard (Devleesschauwer et al., 2014;Havelaar et al.,

2000;Hoekstra et al., 2008;Murray, 1994). The quality of life is de-

termined by the duration of illness and a weighing factor that indicates

the severity of the speciﬁc disease considered (Salomon et al., 2015).

The DALY is increasingly used for risk ranking (Van der Fels-Klerx et al.,

2018) and in burden of disease studies (Havelaar et al., 2015), which

aim to compare and prioritise health risks, it is used as an aid to policy

makers when they have to decide where to spend their available re-

sources. Methods used and results obtained in these studies are also

useful for RBAs because the health eﬀects considered can be the same

and a large part of the underlying calculations is similar.

The DALY is commonly applied at a population level. Burden of

disease, for example, is deﬁned as the sum of individual DALY across

the population, and applied as a measurement of the gap between

current health status and an ideal health situation where the entire

population lives to an advanced age, free of disease and disability

(WHO, 2013). As risk-beneﬁt questions are usually targeted at a change

of intake scenario within the population (Section 2.3), the DALY is also

commonly applied as a population metric in an RBA. However, popu-

lations consist of a large variety of individuals with varying food pre-

paration habits, consumption patterns and sensitivity to food hazards.

When the RBA is done and the risk-beneﬁt balance for the population is

interpreted as the risk-beneﬁt balance for the average consumer, this

does not mean that this balance is the same for all individual con-

sumers. It can be that the balance goes in diﬀerent directions for dif-

ferent subpopulations, e.g., the elderly, pregnant women or children,

and because there are diﬀerences in intake and sensitivity between

individuals. Therefore, the variability between consumers has to be

taken into consideration, for example by using a stochastic approach

(Hart et al., 2013).

Apart from the DALY, other metrics can be used, such as monetary

integrated metrics like the cost-of-illness, which aims to calculate the

direct and indirect monetary costs to society related to disease and

death, or willingness-to-pay, a stated preference method which elicits

the resources an individual is willing to give up for a reduction in a

speciﬁc health risk. We refer to Mangen, Plass, & Kretzschmar, 2014,p.

196, for a comprehensive overview of these diﬀerent metrics.

Even though the use of the DALY seems to be an established choice

in RBAs, one should consider alternatives and remain critical on the

choice of the preferred metric. Because this choice guides part of the

data needs of the RBA and may have an impact on the interpretation of

the ﬁnal result, this choice should be made when the risk-beneﬁt

question is deﬁned. As diﬀerent metrics may convey diﬀerent messages,

the use of more than one metric could be considered as well. When

metrics are used beyond the level of the general population, it is im-

portant to consider the impact of variability between consumers. Both

the risk-beneﬁt assessors and the decision makers should be aware of

the strengths and weaknesses of the health metric chosen, as well as the

underlying ethical dimensions (Arnesen & Kapiriri, 2004;Arnesen &

Nord, 1999;Van der Fels-Klerx et al., 2018).

2.8. Including microbiology

As RBAs have predominantly been developed within the research

areas of nutrition and toxicology, the concepts and deﬁnitions used are

largely based on these two research areas (Section 1.1) and micro-

biology is not often included (Magnússon et al., 2012). Even though one

of the ﬁrst RBA publications relates to the risks and beneﬁts of drinking

water disinfection (Havelaar et al., 2000), only 7 of the 70 references

indicated in the RBA review of Boué et al. (2015) include microbiology.

Among those, there is only one from the BRAFO project, which, among

topics not related to microbiology, discusses heat treatment of milk

(Schütte et al., 2012). Microbiological beneﬁts, e.g., the use of probiotic

bacteria, have to our knowledge not yet been included in an RBA.

Reasons for this underrepresentation of microbiology in RBA are

probably the intrinsic diﬀerences in the underlying research disciplines

and the diﬀerent nature of the associated health eﬀects. Microbiological

risks are often linked with mild health eﬀects such as short episodes of

gastro enteritis. They can also lead to long-term sequelae and severe

chronic eﬀects, but these are typically not registered and less often

measured (Havelaar et al., 2012). In principle, microorganisms can

rather easily be eliminated from foods by application of a heating

process, which might suggest that microbiological risks from food can

quite easily be prevented. However, microbial contamination of food

products and exposure are common, and, to some extent, more easily

accepted by consumers (Kher et al., 2013).

Burden of disease studies (Section 2.7) show an opposite trend

compared with published RBA studies: because the availability of the

relevant data is larger, the recent World Health Organization (WHO)

study on the global burden of foodborne disease (Havelaar et al., 2015)

is primarily focused on microbiological hazards, and only four chemical

substances have been considered in the WHO report. The results suggest

that the disease burden related to the exposure to microorganisms may

be larger than that for chemicals, but more comparable disease burden

estimates for chemical substances are required before an overall com-

parison between the burden of chemical substances and microbiological

pathogens can be made. However, the results conﬁrm that risk asso-

ciated with microbiological hazards can be quantiﬁed and that it is

important to include microbiological risks in RBAs as well.

The inclusion of microbiological risks and beneﬁts in RBAs requires

that the speciﬁc characteristics of microbiological agents are acknowl-

edged, and that they are included in case studies. As illustrated by

Berjia et al. (2012) microbiological risks can speciﬁcally be of im-

portance when the eﬀects of food processing are included in the risk-

beneﬁt question, as the doses largely depend on the storage and food

preparation. It would therefore be advisable that data on food pre-

paration (such as storage times, temperatures and the applied cooking

style) are included in dietary surveys.

The challenges from diﬀerences in approach between chemical and

microbiological risk assessment needs further study to allow the de-

velopment of a more integrated approach towards RBAs (Sections 1.2

and 2.5). Recently developed tools that are increasingly adapted to

allow comparisons between chemical and microbiological health risks

(e.g. FDA-iRisk; Chen et al., 2013) can help to address these challenges.

2.9. The scope of risk-beneﬁt assessments

The scope of a risk-beneﬁt question in relation to food may be much

wider than direct health impact and can include socio-economic, psy-

chological and/or environmental dimensions (Boobis et al., 2013).

When consumers select their food, the health eﬀect is only one of the

concerns; others include cost, taste, quality and sustainability of the

production. An indicated health risk may be counterbalanced by each of

these, for example, if low price and good taste are considered beneﬁts

that outbalance the health risk.

One may consider widening the scope of RBAs of foods and include

some of the aspects mentioned above. Cost is an obvious choice, which

is an intrinsic part of the RBA when metrics such as the cost-of-illness or

willingness-to-pay are used (Section 2.7). It can also be added to the

RBA by means of a cost-utility, cost-beneﬁt or cost-eﬀectiveness ana-

lysis, as for example done for the costs of intervention strategies that

aim to lower the public health risks of Campylobacter from broiler meat

(Mangen et al., 2007;Van Wagenberg, Van Horne, Sommer, & Nauta,

2016). Measurements such as the “cost per avoided DALY”can be

highly informative for risk-beneﬁt managers because they can indicate

the economic consequences of scenarios in RBAs and allow for a com-

parison of policies.

M.J. Nauta et al. Trends in Food Science & Technology 76 (2018) 90–100

Also, environmental sustainability can be taken into account, for

example by the use of life cycle assessment (LCA), a product-oriented

environmental assessment tool that provides a systematic way to

quantify the environmental eﬀects of individual products or services

(Hermansen & Nguyen, 2012). A methodology is being developed to

include nutritional health impacts in LCA (Stylianou et al., 2016),

which could clearly contribute to the development of RBAs with a scope

beyond immediate health eﬀects of food intakes.

Ultimately, it can be attractive to address all of the relevant aspects

in one overall analysis, for example by the use of multi criteria decision

analysis (MCDA). This method has for example been applied to the

prioritisation of foodborne pathogens (Ruzante et al., 2010), taking into

account public health impact (expressed in DALY and cost-of-illness),

market impact, consumer perception and acceptance, and social sensi-

tivity to impacts on vulnerable consumer groups and industries. In

MCDA, an integrating scoring method is developed, which weighs the

importance of diﬀerent factors that are considered relevant for the

decision making, allowing one to come with a ﬁnal ranking that in-

cludes all of these factors.

Deﬁning the scope of the RBA is clearly an issue that should be

decided upon when the risk-beneﬁt question is formulated. A broader

scope includes more relevant issues, but also implies an increasing

demand for resources in terms of research eﬀorts, data and method

development. Clearly, challenges that complicate RBAs, such as the lack

of data and knowledge, and the consequential uncertainties, the im-

balance in level of scientiﬁc evidence and the use of quantitative me-

trics, only get more weight when a broader scope is taken. Yet, the

ongoing developments show that progress can be made, and with

multidisciplinary scientiﬁc collaboration and investment in research

supporting RBAs, this progress can be strengthened in the future.

2.10. The application of risk-beneﬁt assessments

So far, several RBAs have been performed, but mainly within re-

search projects that were directed at the development of RBA frame-

works and methodology. The aim of these RBAs was primarily to il-

lustrate the potential of the methodology and the risk-beneﬁt question

was not posed by independent risk-beneﬁt managers but by the re-

searchers themselves. There is now a need for more experience with the

practical application of RBAs and the proposed methodologies. These

practical applications of RBAs can fall into two categories: those leading

to recommendations or guidelines to food safety and health authorities,

and those leading to process and formulation design by industry (Boué

et al., 2015). The ﬁrst application is the one considered most often and

typically the request for such an RBA originates from national or in-

ternational food and health authorities that have a mandate to advise

the public on a particular food or diet and have identiﬁed a need to

establish a scientiﬁc basis for this advice. Examples are an RBA on ﬁsh

and ﬁsh products performed in Norway (Skåre et al., 2015) and an RBA

on nuts performed in Denmark (Mejborn et al., 2015). Another reason

for the authorities to make requests for an RBA is a need for an eva-

luation of health eﬀects of proposed fortiﬁcation of foods, as for ex-

ample with vitamin D, folic acid (Hoekstra et al., 2008) or iodine

(Zimmermann, 2008).

Food producers may have an interest in RBAs when they change

their production or the formulation of their products. This is especially

of interest when this change is based on a wish to decrease one speciﬁc

health risk that can go at the expense of another. For example, when a

heating step is introduced to decrease microbiological health risks, this

can go at the expense of the formation of potentially carcinogenic

substances (Havelaar et al., 2000) and/or decreased vitamin levels. In

such cases, RBA can be an excellent tool to settle a dispute that cannot

be solved on the basis of the identiﬁcation of risks and beneﬁts alone.

The challenge from increased application of RBAs can only be met

by initiating more speciﬁc RBA projects based on current demands of

risk-beneﬁt managers and by performing RBAs in practice. Food safety

and health authorities and the food industry should be open for mul-

tidisciplinary collaboration and should be made aware of the potential

of RBAs. When RBAs are performed, they should be published in the

international peer-reviewed literature, even if a lack of data or major

uncertainties obstruct ﬁrm conclusions. This is important to assure the

scientiﬁc quality, to increase the experience in the research community

and to aid the international discussion on the potential and challenges

of RBAs.

Table 1

A summary of the challenges in risk-beneﬁt assessment as discussed in this paper, with a brief indication of the proposed way forward.

Topic Challenge Suggested way forward

Deﬁnitions Deﬁnitions of basic concepts diﬀer between disciplines underlying RBA. Create awareness and reach consensus.

Top-down versus bottom-up Risk and beneﬁt assessments can be based on top-down human

observational evidence or bottom-up risk assessment approaches,

which may provide diﬀerent health eﬀect estimates of food compounds

or contaminants.

Perform studies that combine the two approaches to compare potential

bias and uncertainties, either by case studies or simulation studies.

Risk-beneﬁt question A wide and confusing range of questions is possible, which may require

diﬀerent methods.

Deﬁne the risk-beneﬁt question in close collaboration with risk-beneﬁt

managers. Categorise questions and frame the risk-beneﬁt question

schematically.

Lack of data and knowledge;

uncertainty

Missing data and knowledge can lead to large uncertainties attending

RBA.

Identify, characterise and communicate uncertainties; ﬁll up the crucial

identiﬁed data gaps.

Imbalance of level of

evidence

The level of evidence required for beneﬁts is usually larger than for

risks, hence risks are more likely to be included in RBAs.

Put emphasis on the size of the health eﬀect rather than on the presence

or absence of the health eﬀect.

Substitution When an alternative intake scenario implies a change in consumption

of one food product, it will have consequences for others. There can be

many options for substitution.

Find a comparable food product and include it in the analysis, use

isocaloric alternatives, or compare several scenarios.

Quantitative metrics Qualitative and quantitative approaches can be used and various health

metrics can be selected. They can be applied both at population level

and individual level.

More than one metric can be useful, quantitative assessments can be

preferable even if the risk-beneﬁt balance is clear. Well balanced choices

for the metrics applied have to be made when the risk-beneﬁt question is

deﬁned.

Including microbiology Microbiology is not well integrated in current RBA methods, deﬁnitions

and concepts may be diﬀerent. Yet it is an intrinsic part of food safety

with signiﬁcant health implications and therefore it should be included

in RBAs.

Perform more RBAs that include microbiological hazards, take

advantage of experience in disease burden estimation and risk ranking.

Scope The scope of RBAs can be extended beyond health concerns, for

example by including costs and environmental sustainability.

Develop methods and metrics to do this further, integrate methods such

as LCA and MCDA into RBAs.

Application The (Quantitative) RBA methodology has not yet been applied much, it

is unclear to what extent the developed methods are practically

applicable.

With case studies, show how useful the RBA can be in diﬀerent areas and

discuss experiences.

M.J. Nauta et al. Trends in Food Science & Technology 76 (2018) 90–100

3. Conclusion

RBA is an evolving discipline in food safety and nutrition that takes

advantage of achievements in a variety of underlying disciplines. As it

integrates various health concerns, it is a valuable method to estimate

the overall health eﬀects related to food consumption and diet choice,

which can be applied both by food and health authorities and the food

industry. Recognizing the progress that has been made in the past

decade and based on previous work, we have identiﬁed a series of

challenges that should be met to develop the area further and indicated

steps that should be taken for further progress. The challenges and

suggested ways forward in meeting them are summarized in Table 1.

To meet the challenges of RBA, it is important that researchers in

underlying disciplines and stakeholders in food regulation, production,

retail and consumption from diﬀerent regions in the world agree on

deﬁnitions and concepts that are practical and agreeable for all. Based

on relevant risk-beneﬁt questions, a series of risk-beneﬁt studies should

be performed, not so much to develop methods, but predominantly to

identify the practical challenges that are met when working on RBA

case studies. When investigating these practical challenges, steps can be

made in categorizing them and in developing and harmonising agree-

able methods to address them.

For the future development of the RBA area, it is important to

perform methodological research into some of the identiﬁed challenges

because they cannot be met by performing case studies alone. Examples

are studies into the diﬀerences and similarities in results obtained from

top-down compared with bottom-up approaches (by the application of

comparative analytical tools and simulation studies), research into

uncertainty analysis and comparative studies on integrated health

metrics and metrics outside the health domain. Additionally, risk

communication is one of the key pillars in risk analysis and should also

be an inherent part of RBAs of foods, particularly for the communica-

tion of quantitative metrics and their attending uncertainties to all

stakeholders.

Overall, with an increasing demand from diﬀerent stakeholders for

holistic and objective assessments of the health eﬀect of foods, multi-

disciplinary RBA is a promising research area for the future. Impressive

progress has been made and, despite the remaining challenges, we ex-

pect that more progress will be made in the next decade. The steps

forward proposed in this paper will be useful in taking the research area

further, allowing for transparent and reliable RBAs to be performed on

a wider scale in the future.

Funding

The preparation of this manuscript was funded through the Metrix

project by the Ministry for Environment and Food in Denmark.

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Glossary

ADI: Acceptable daily intake

ARfD: Acute reference dose

BMD: Benchmark dose

BRAFO: Beneﬁt and Risk Analysis for Foods (EU project)

DRV: Dietary reference value

DHA: Docosahexaenoic acid

EFSA: European Food Safety Authority

EPA: Eicosapentaenoic acid

FAO: Food and Agriculture Organization of the United Nations

FSO: Food safety objective

IPCS: International Programme of International Safety

LCA: Life cycle assessment

LOAEL: Lowest observed adversary eﬀect level

LTI: Lower threshold intake

MCDA: Multi criteria decision analysis

NOAEL: No observed adversary eﬀect level

RBA: Risk-beneﬁt assessment

TDI: Tolerable daily intake

UL: Upper intake level

WHO: World Health Organization

M.J. Nauta et al. Trends in Food Science & Technology 76 (2018) 90–100

100

Risk–benefit assessment of foods and its role to inform policy decisions: outcome of an international workshop

Article

Full-text available

Sep 2024

Policy decisions in public health require consideration and evaluation of trade-offs for which transparency and science-based evidence is needed. Improvement of decision-support tools is essential to help guide food policy decisions that promote healthy diets and meet the challenges of food systems without compromising food security, food safety, and sovereignty. Risk–benefit assessment of foods (RBA) is an established methodological approach designed to inform policy decisions within the area of nutrition and food safety. Despite methodological developments, translation of RBA findings into policies is still limited. In this context, a stakeholder workshop held in May 2023 gathered RBA experts and food regulators from Europe to identify the challenges, obstacles and opportunities in using evidence generated through RBAs to inform food policy decisions. A structured process was implemented to collect their views through online surveys, breakout groups, and plenary discussions. As a secondary objective, food regulators’ views on other approaches for holistic risk assessment fit for food systems analysis were also explored. This paper summarizes the main findings of the workshop and discusses policy implications and future perspectives to improve the area of RBA and its role in food policymaking.

Joint FAO/WHO Expert Consultation on the Risks and Benefits of Fish Consumption: Meeting Report

Book

Full-text available

Oct 2024

Evolving science and debate concerning the benefits and risks of consuming fish have resulted in confusion over the years, and national and international food safety agencies have recognized the need to provide useful, clear and relevant information in this regard to consumers. In October 2023, FAO and WHO held the second Joint FAO/WHO Expert Consultation on the Risks and Benefits of Fish Consumption to analyse new scientific evidence on the matter and draw relevant conclusions and recommendations. The overall conclusions of the exercise show that consuming fish provides energy, protein and a range of other nutrients important for health, and that there are benefits related to fish consumption during all life stages (pregnancy, childhood and adulthood). General population studies show that the benefits and individual effects of fish consumption vary depending on overall diet, the characteristics of consumers, and the fish that is consumed.

Risk–benefit assessment of shifting from traditional meat‐based diets to alternative dietary patterns

Article

Full-text available

Dec 2022

The consumption of plant-based meat alternatives has recently transitioned from the niche market tothe mainstream. However, changing the dietary patterns may lead to new health challenges referred topossible higher exposure to natural toxins found in plant-based food. The present project aimed totrain the fellow in the field of chemical risk assessment and provide a comprehensive overview on howa change towards plant-based meat alternatives may represent a driver for emerging risks. Thus,within the EU-FORA programme the fellow engaged in the following activities: (i) perform a systematicreview to analyse the distribution of natural toxins in the most common plant-based meat alternativesin Europe, (ii) risk–benefit assessment of shifting from meat-based diets to soy-based meatalternatives by modelling the substitution of meat with soy, and (iii) determine the occurrence ofmycotoxins in plant-based meat alternatives from local markets in Parma, Italy. The fellow learnt thechemical risk assessment procedures applied by the researchers from the Department of Food andDrug of Parma University, thus gaining an in-depth expertise in all the steps. A risk–benefit assessmentwas performed modelling the intake of aflatoxin B1-contaminated soy-based meat analogues. Thehealth impact due to intake of soy and exposure to aflatoxin B1 was estimated. Within the researchgroup, the fellow also worked on developing a multi-mycotoxin determination method for plant-basedmeat alternatives matrices. The results of the project provide a picture reflecting the occurrence ofnatural toxins in plant-based meat alternatives and the need of upgraded regulation frameworks thattake into account new products and dietary patterns. The EU-FORA fellowship was a great opportunityfor the fellow to expand his professional network and increase his expertise in food safety by gainingnew skills in chemical risk assessment, risk–benefit assessment and analytical chemistry.

Editorial: Risk-benefit assessment of foods: Advances in public health

Article

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Nov 2022

13. Food toxicology

Chapter

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Oct 2022

Aalt Bast

Integration of National Chemical Hazards Monitoring, Total Diet Study and Human Biomonitoring Programmes for Food Safety Exposure Assessment in Singapore

Article

Nov 2024

Holistic risk assessments of food systems

Article

Full-text available

Sep 2024

Food systems are composed of interrelated activities that transform agricultural products into food. Their operations need to meet several food security, food safety, and sustainability requirements. Therefore, risk assessment of food systems must be multidisciplinary and include food safety, nutrition, environmental, economics, and social criteria. However, combining these criteria to assess multiple impacts remains a challenge in complex and multi-stakeholder systems. Until now, only a few holistic assessments, whether domain-oriented or generic and with different levels of quantification, have covered all criteria and the whole food systems. We reviewed and presented the various assessment methods and their applications in food systems, highlighting their advantages and disadvantages. Recommendations were made for a tiered approach combining different holistic assessment methods.

Guidance on risk–benefit assessment of foods

Article

Full-text available

Jul 2024

The EFSA Scientific Committee has updated its 2010 Guidance on risk–benefit assessment (RBA) of foods. The update addresses methodological developments and regulatory needs. While it retains the stepwise RBA approach, it provides additional methods for complex assessments, such as multiple chemical hazards and all relevant health effects impacting different population subgroups. The updated guidance includes approaches for systematic identification, prioritisation and selection of hazardous and beneficial food components. It also offers updates relevant to characterising adverse and beneficial effects, such as measures of effect size and dose–response modelling. The guidance expands options for characterising risks and benefits, incorporating variability, uncertainty, severity categorisation and ranking of different (beneficial or adverse) effects. The impact of different types of health effects is assessed qualitatively or quantitatively, depending on the problem formulation, scope of the RBA question and data availability. The integration of risks and benefits often involves value‐based judgements and should ideally be performed with the risk–benefit manager. Metrics such as Disability‐Adjusted Life Years (DALYs) and Quality‐Adjusted Life Years (QALYs) can be used. Additional approaches are presented, such as probability of all relevant effects and/or effects of given severities and their integration using severity weight functions. The update includes practical guidance on reporting results, interpreting outcomes and communicating the outcome of an RBA, considering consumer perspectives and responses to advice.

Substituting red meat with insects in burgers: Estimating the public health impact using risk-benefit assessment

Article

May 2024
FOOD CHEM TOXICOL

ET VE ET ÜRÜNLERİNDE POLİSİKLİK AROMATİK HİDROKARBONLARIN OLUŞUM MEKANİZMALARI VE AZALTICI YAKLAŞIMLARFORMATION MECHANISMS AND REDUCTION STRATEGIES FOR POLYCYCLIC AROMATIC HYDROCARBONS IN MEAT AND MEAT PRODUCTS

Article

Full-text available

Nov 2022

Betul Karslioglu

Polisiklik aromatik hidrokarbonlar (PAH) et ve et ürünlerinin yüksek sıcaklıklarda pişirilmesi sonucu oluşan mutajenik ve kanserojenik bileşikler olup, bu bileşiklere maruz kalmanın en yaygın yolu diyet alımıdır. Et ve et ürünlerinde yüksek miktarda oluşan bu PAH bileşiklerinin oluşumuna pişirme yöntemi, pişirme sıcaklığı, pişirme süresi, etin yağ içeriği gibi birçok faktör etkilidir. PAH bileşiklerinin oluşumu kaçınılmaz olmakla birlikte, oluşum mekanizmalarının bilinmesi oluşan PAH seviyelerinin azaltılması ve engellenmesi açısından önemlidir. Bu organik kirleticilerin sağlık üzerine olumsuz etkilerinin bulunması, gıdalarda bu bileşiklerin oluşumunun azaltılmasına veya engellenmesine dair stratejiler uygulanmasına neden olmaktadır. PAH oluşumunu azaltıcı yaklaşımlar ısıl işlem sıcaklığının ve süresinin mümkün olduğunca düşürülmesi, alternatif pişirme yöntemlerinin kullanımı, pişirme yöntemlerinin modifikasyonu, marinasyon uygulaması, et ve et ürünlerinin kimyasal kompozisyonundaki değişiklikler gibi önlemleri kapsamaktadır. Bu çalışmada et ve et ürünlerinde PAH oluşum mekanizmaları ve oluşum düzeyinin azaltılmasına dair stratejilerin detaylı olarak açıklanması amaçlanmıştır.

The 2015 Dutch food-based dietary guidelines

Article

Full-text available

Apr 2016

The objective of this study was to derive food-based dietary guidelines for the Dutch population. The dietary guidelines are based on 29 systematic reviews of English language meta-analyses in PubMed summarizing randomized controlled trials and prospective cohort studies on nutrients, foods and food patterns and the risk of 10 major chronic diseases: coronary heart disease, stroke, heart failure, diabetes, breast cancer, colorectal cancer, lung cancer, chronic obstructive pulmonary disease, dementia and depression. The committee also selected three causal risk factors for cardiovascular diseases or diabetes: systolic blood pressure, low-density lipoprotein cholesterol and body weight. Findings were categorized as strong or weak evidence, inconsistent effects, too little evidence or effect unlikely for experimental and observational data separately. Next, the committee selected only findings with a strong level of evidence for deriving the guidelines. Convincing evidence was based on strong evidence from the experimental data either or not in combination with strong evidence from prospective cohort studies. Plausible evidence was based on strong evidence from prospective cohort studies only. A general guideline to eat a more plant food-based dietary pattern and limit consumption of animal-based food and 15 specific guidelines have been formulated. There are 10 new guidelines on legumes, nuts, meat, dairy produce, cereal products, fats and oils, tea, coffee and sugar-containing beverages. Three guidelines on vegetables, fruits, fish and alcoholic beverages have been sharpened, and the 2006 guideline on salt stayed the same. A separate guideline has been formulated on nutrient supplements. Completely food-based dietary guidelines can be derived in a systematic and transparent way.European Journal of Clinical Nutrition advance online publication, 6 April 2016; doi:10.1038/ejcn.2016.52.

World Health Organization Global Estimates and Regional Comparisons of the Burden of Foodborne Disease in 2010

Article

Full-text available

Dec 2015
PLOS MED

Illness and death from diseases caused by contaminated food are a constant threat to public health and a significant impediment to socio-economic development worldwide. To measure the global and regional burden of foodborne disease (FBD), the World Health Organization (WHO) established the Foodborne Disease Burden Epidemiology Reference Group (FERG), which here reports their first estimates of the incidence, mortality, and disease burden due to 31 foodborne hazards. We find that the global burden of FBD is comparable to those of the major infectious diseases, HIV/AIDS, malaria and tuberculosis. The most frequent causes of foodborne illness were diarrheal disease agents, particularly norovirus and Campylobacter spp. Diarrheal disease agents, especially non-typhoidal Salmonella enterica, were also responsible for the majority of deaths due to FBD. Other major causes of FBD deaths were Salmonella Typhi, Taenia solium and hepatitis A virus. The global burden of FBD caused by the 31 hazards in 2010 was 33 million Disability Adjusted Life Years (DALYs); children under five years old bore 40% of this burden. The 14 subregions, defined on the basis of child and adult mortality, had considerably different burdens of FBD, with the greatest falling on the subregions in Africa, followed by the subregions in South-East Asia and the Eastern Mediterranean D subregion. Some hazards, such as non-typhoidal S. enterica, were important causes of FBD in all regions of the world, whereas others, such as certain parasitic helminths, were highly localised. Thus, the burden of FBD is borne particularly by children under five years old-although they represent only 9% of the global population-and people living in low-income regions of the world. These estimates are conservative, i.e., underestimates rather than overestimates; further studies are needed to address the data gaps and limitations of the study. Nevertheless, all stakeholders can contribute to improvements in food safety throughout the food chain by incorporating these estimates into policy development at national and international levels.

The role of hazard- and risk-based approaches in ensuring food safety

Article

Full-text available

Oct 2015
TRENDS FOOD SCI TECH

Background: Food legislation in the European Union and elsewhere includes both hazard- and risk-based approaches for ensuring safety. In hazard-based approaches, simply the presence of a potentially harmful agent at a detectable level in food is used as a basis for legislation and/or risk management action. Risk-based approaches allow consideration of exposure in assessing whether there may be unacceptable risks to health. Scope and approach: The advantages and disadvantages of hazard- and risk-based approaches for ensuring the safety of food chemicals, allergens, ingredients and microorganisms were explored at an ILSI Europe workshop. Key findings and conclusions: It was concluded that both types of approach have their place, depending on the context. However, problems can arise when both types of approach are used in regulation by separate agencies that address different aspects of the same agent/substance present in food. This separation of decision-making can result in hazard-based restrictions on marketing and use, whereas risk-based assessments for those exposed show there is reasonable certainty no harm will result. This in turn can lead to contradictory, confusing and ultimately unnecessary actions. Use of hazard-based approaches for foods also means that comparisons with benefits for nutrition and food security cannot be undertaken. This has the potential to lead to bias in the overall conclusions of regulators and risk managers, who may not have been presented with the benefits of particular foods. The value of risk-based approaches is becoming increasingly recognised.

A life cycle assessment framework combining nutritional and environmental health impacts of diet: A case study on milk

Article

Full-text available

May 2016
INT J LIFE CYCLE ASS

Purpose While there has been considerable effort to understand the environmental impact of a food or diet, nutritional effects are not usually included in food-related life cycle assessment (LCA). Methods We developed a novel Combined Nutritional and Environmental Life Cycle Assessment (CONE-LCA) framework that evaluates and compares in parallel the environmental and nutritional effects of foods or diets. We applied this framework to assess human health impacts, expressed in Disability Adjusted Life Years (DALYs), in a proof-of-concept case study that investigated the environmental and nutritional human health effects associated with the addition of one serving of fluid milk to the present average adult US diet. Epidemiology-based nutritional impacts and benefits linked to milk intake, such as colorectal cancer, stroke, and prostate cancer, were compared to selected environmental impacts traditionally considered in LCA (global warming and particulate matter) carried to a human health endpoint. Results and discussion Considering potential human health effects related to global warming, particulate matter, and nutrition, within the context of this study, findings suggest that adding one serving of milk to the current average diet could result in a health benefit for American adults, assuming that existing foods associated with substantial health benefits are not substituted, such as fruits and vegetables. The net health benefit is further increased when considering an iso-caloric substitution of less healthy foods (sugar-sweetened beverages). Further studies are needed to test whether this conclusion holds within a more comprehensive assessment of environmental and nutritional health impacts. Conclusions This case study provides the first quantitative epidemiology-based estimate of the complements and trade-offs between nutrition and environment human health burden expressed in DALYs, pioneering the infancy of a new approach in LCA. We recommend further testing of this CONE-LCA approach for other food items and diets, especially when making recommendations about sustainable diets and food choices.

The EFSA's 6th Scientific Colloquium Report - Risk-benefit analysis of foods: methods and approaches

Article

Jul 2007

European Food Safety Authority (EFSA

Microbiological risk assessment

Article

Jun 2016

Microbiological risk assessment is defined by the CODEX Alimentarius Commission as ‘a scientifically based process consisting of the following steps: (i) hazard identification; (ii) hazard characterisation; (iii) exposure assessment; and (iv) risk characterisation’. It is one of the components of microbiological risk analysis, which has the overall objective to minimise food-borne risks to consumers. It is a complex discipline that continues to evolve and challenges and new opportunities were discussed during the breakout session ‘Microbiological risk assessment’ held at the EFSA 2nd Scientific Conference ‘Shaping the Future of Food Safety, Together’ (Milan, Italy, 14–16 October 2015). Discussions focussed on the estimation of the global burden of food-borne disease, the prioritisation of microbiological risks taking into account uncertainty, the challenges in risk assessment when dealing with viruses, the contribution of typing methods to risk assessment and approaches to deal with uncertainty in risk assessment in emergency situations. It was concluded that the results of the global burden of food-borne disease study provide, for the first time, a comprehensive comparison of risks due to different hazards and this will be an important input to food safety strategies at the global, regional and national levels. Risk ranking methodologies are an important tool for priority setting. It is important to consider the underestimation (e.g. due to bias in reporting). Typing methods for microbial hazards inevitably impact on risk assessment and can have an important influence on the accuracy of source attribution studies. Due to their high genetic diversity and the limitations of current diagnostic methods, it is still challenging to obtain robust evidence for food-borne outbreaks caused by viruses and more research is needed on the use of whole genome sequencing in this area. The lessons learnt from the recent enterohaemorrhagic Escherichia coli (EHEC) outbreak in Germany include the need for more effective and timely connections within and between institutions as responses unfold.

Cost-effectiveness of Campylobacter interventions on broiler farms in six European countries

Article

Jun 2016

Broilers are an important reservoir for human Campylobacter infections, one of the leading causes of acute diarrheal disease in humans worldwide. Therefore, it is relevant to control Campylobacter on broiler farms. This study estimated the cost-effectiveness ratios of eight Campylobacter interventions on broiler farms in six European countries: Denmark, the Netherlands, Norway, Poland, Spain, and United Kingdom. The cost-effectiveness ratio of an intervention was the estimated costs of the intervention divided by the estimated public health benefits due to the intervention, and was expressed in euro per avoided disability-adjusted life year (DALY). Interventions were selected on the basis of a European risk factor study and other risk factor research. A deterministic simulation model was developed to estimate the cost-effectiveness ratio of each intervention, if it would be implemented on all broiler farms in a country where it isn't implemented yet and implementation is possible. The model considered differences between countries in number and size of broiler farms and established practices, in import, export and transit of live broilers, broiler meat and meat products, in effect of interventions on Campylobacter prevalence in broilers, in disease burden of Campylobacter related human illness, in national economic factors, such as interest rate and general cost levels, and in technical and economic farm performance. Across interventions, cost-effectiveness ratios were the lowest for Poland and Spain, and highest for Norway and Denmark. Across countries, applying designated tools for each farm house and building an anteroom with hygiene barrier in each farm house had the lowest cost-effectiveness ratios, whereas a ban on thinning (partial depopulation), slaughter at 35 days, replacing old houses by new houses, and applying drink nipples without cup had the highest. Applying fly screens in Denmark had an intermediate cost-effectiveness ratio. A maximum downtime between flocks of ten days had a negative cost-effectiveness ratio (i.e. revenue) in Poland, a low positive cost-effectiveness ratio in Spain and high positive cost-effectiveness ratios in Denmark, the Netherlands and United Kingdom. Estimated cost-effectiveness ratios of Campylobacter interventions on broiler farms differed substantially between the six countries, but the order of interventions in increasing cost-effectiveness ratio was generally similar across the countries.

Life cycle assessment and the agri-food chain

Chapter

Dec 2012

Our food consumption is responsible for a major part of the environmental impact related to our total consumption. Life cycle assessment (LCA) is a product-oriented tool that can be used efficiently to identify improvement options within the food chain covering a product’s life cycle from cradle to grave, which is very complex for many foods, and to support choices of consumption. The LCA methodology is supported by public standards and public policy measures and has proved its value in business development for more environmentally friendly products. It is an essential feature that the effects of resource use and emissions associated with a product’s life cycle can be aggregated into impact categories (e.g., nonrenewable energy use, land occupation, global warming, acidification, etc.) and further aggregated into overall damage impacts (e.g., impacts on biodiversity, human health, and resource productivity), and these impacts can be even monetarized in a single score. No doubt, uncertainty because of assumptions created increases in the level of aggregation, so a trade-off exists in having a tool for easy communication and a high level of certainty in the assessment. However, a sound theoretical framework for aggregation facilitates the coherent use of the LCA results in different purposes and by different stakeholders. There is a need, nonetheless, to further develop the methodology, including land use impacts resulting from increased demand for food. It has been demonstrated that this inclusion may change the ranking of different foods regarding environmental impact, but above all it will typically enhance differences between foods of animal and plant origin, and particularly regarding the impact on global warming.

Critical review of methods for risk ranking of food related hazards, based on risks for human health

Article

Feb 2016

This study aimed to critically review methods for ranking risks related to food safety and dietary hazards on the basis of their anticipated human health impacts. A literature review was performed to identify and characterize methods for risk ranking from the fields of food, environmental science and socio-economic sciences. The review used a predefined search protocol, and covered the bibliographic databases Scopus, CAB Abstracts, Web of Sciences, and PubMed over the period 1993–2013. All references deemed relevant, on the basis of of predefined evaluation criteria, were included in the review, and the risk ranking method characterized. The methods were then clustered – based on their characteristics - into eleven method categories. These categories included: risk assessment, comparative risk assessment, risk ratio method, scoring method, cost of illness, health adjusted life years, multi-criteria decision analysis, risk matrix, flow charts/decision trees, stated preference techniques and expert synthesis. Method categories were described by their characteristics, weaknesses and strengths, data resources, and fields of applications. It was concluded there is no single best method for risk ranking. The method to be used should be selected on the basis of risk manager/assessor requirements, data availability, and the characteristics of the method. Recommendations for future use and application are provided.

Microbial Food Safety Risk Assessment

Article

Dec 2013

Anna Lammerding

Microbial food safety risk assessment is a systematic approach to aid our understanding of complex food systems and to translate the potential presence of pathogens in the food production, processing, and preparation environments into statements of the likelihood and magnitude of a food safety risk, in terms of adverse public health outcomes. The Codex Alimentarius Commission, the international body responsible for defining risk assessment principles and practices for all foodborne hazards, endorses a framework for risk assessment that provides a structured format and process for MRA. However, this guidance is not intended to be prescriptive but allows for different approaches and the use of novel analytical tools for assessing risk, to translate scientific data and knowledge into practical information to better inform managers and decision-makers when dealing with the many challenges that arise in the complex field of food safety.

Meeting the challenges in the development of risk-benefit assessment of foods

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