Risk-benefit analysis expresses an integrated approach to the evaluation of food and nutritional safety, through the simultaneous analysis of the beneficial properties and potential health risks that may arise from the consumption of a food, also taking into account its role in the diet.
The correct execution of the Risk-Benefit Analysis (RBA) can allow the adoption of policies, rules and dietary guidelines consistent with the objectives of improving the health status of populations and reducing the risks associated with nutrition.
This article aims to provide an overview of the state of the art on risk-benefit analysis, and some future perspectives that may arise from its broader use to evaluate different diet styles, nutrition and control of diseases or other pathological states, health claims related to foods.
EFSA’s scientific colloquium
Risk-benefit analysis was extensively discussed by the European Food Safety Authority (EFSA) during the sixth of a series of scientific colloquia aimed at launching the idea of a harmonised framework for food safety assessment. (1)
The risk-benefit analysis is inspired by the principle of risk analysis contained in Regulation (EC) No. 178/2002 (General Food Law) and is therefore divided into three distinct parts:
- Risk-benefit assessment (RBA): the most important part, from an operational point of view and for the execution of the subsequent steps, starts with the formulation of the problem up to the definition of the results that must be considered by the risk manager and communicated to other authorities or to consumers;
- Risk-benefit management: the phase where the risk manager must weigh the risks and health benefits identified by the RBA, on the basis of the results obtained therein;
- Risk-benefit communication: communication between risk assessors and risk managers is fundamental, because it determines the understanding that the latter have of the results achieved and, subsequently, of the presentation to the company for the provision of nutritional and dietary advice or guides.
The conclusions of the scientific interview reported that this type of analysis should not be conducted regardless, but following a case-by-case evaluation, in order to determine the need to proceed on the basis of the problem formulation. To ensure a better expression of the results relative to the target (sub)population, risk assessors and managers need a continuous dialogue also useful for better communication towards consumers.
DTU research work
Denmark Technical University (DTU) is a leading exponent of the use of risk-benefit analysis on foods, with a whole dedicated research group under the leadership of Dr. Morten Poulsen. Following the adoption of Fødevareforlig (Food Agreement) 3 by the Danish Parliament, and with co-funding from EFSA, the Metrix project was launched, aimed (in part) at conducting RBA on foods. (2)
The overall goal of the project was to quantify positive and negative impacts on the health of nutrients, foods and diets, which are used to perform risk-benefit assessments, calculate disease burden estimates and classify food-related risks in Denmark. The specific objectives of Metrix were:
- develop and apply burden of disease methods to estimate the impact of a selected list of priority chemical and microbiological food hazards;
- apply methods to estimate the relative contribution of different foods to estimate the disease burden;
- classify foodborne hazards and foods based on the estimated disease burden;
- identify and characterize groups of Danish individuals whose dietary and lifestyle patterns present a high disease burden due to exposure to food-borne chemical hazards.
The results of the project have allowed us to illustrate ways of developing alternative scenarios related to the replacement of foods present in the diet of the Danish population with other types of foods, in order to evaluate the effect on the increase in disability adjusted life year (DALY), and develop personalized food integration models, using the fish as a reference food, taking into account beneficial substances (e.g. omega-3) and risk substances (e.g. methylmercury).
BRAFO Project
The project Benefit-Risk Analysis of Foods (BRAFO) (3), funded by the EU under the Framework Programme (FP) 6, aimed to develop a framework that allows a quantitative comparison of the risks and benefits for human health of foods and food compounds based on a common measurement scale. This is based on the assessment of changes in quality/length of life using a system that allows weighting of data quality and severity of effect, with quantification by QALY or DALY methodology.
The framework took into account the interrelationship of risks/benefits, also taking into account different subpopulations, including those defined by genetic polymorphisms. It is intended that the methodology developed should be sufficiently transparent to serve as a reference for the harmonisation of valuation methods used within the EU and more widely in international valuation.
The project followed the results of the projects EC FUFOSE, PASSCLAIM and FOSIE. The outcome of FOSIE was a risk assessment framework for chemicals in food; FUFOSE and PASSCLAIM focused specifically on benefit assessment, with particular emphasis on the identification of markers and harmonised methods for the assessment of health claims.
RBA, EFSA guidelines
EFSA has recently updated the first 2010 RBA guidelines (which inspired the BRAFO project), at the request of Member States, to better adapt RBA results to their needs for developing national food-based dietary guidelines. Thus, to include the risks and benefits (e.g. contaminants, nutrients) of the various categories or types of foods and to meet the regulatory and risk management needs of the European Commission and Member States. (4) Conducting an RBA requires compliance with the following main points:
- problem formulation: required to start RBA correctly;
- adopting a phased approach (tiered approach): in order to adopt more useful approaches to conclude the RBA early, if the assessment allows us to understand that it is not necessary to proceed (e.g. if the risks outweigh the benefits, or vice versa);
- selection of components and significant health effects: a diet, or their foods or components can be chosen to perform the RBA (e.g. Mediterranean diet, fish, omega-3);
- characterization of adverse and beneficial effects: evaluation of their dose-response relationship, i.e. their mutual influence;
- exposure assessment: as a function of the intake by consumers for the reference (sub)population, and for this reason it is considered a key element of the analysis;
- characterization of risks and benefits: EFSA suggests different methods based on the reference tier and the element to be assessed;
- integration of risks and benefits: quantitative (e.g. DALY, QALY) or qualitative measures can be used to attribute an effect to the RBA outcome;
- consideration of variability and uncertainty, linked to individual characteristics and the availability of accurate data with respect to the reference population.
The conclusion of the RBA must be adequately reported to the risk-benefit manager, starting from the formulation, illustrating all the methods and approaches used and the data processed, necessary to draw the conclusions considering the related uncertainties.
The communication of the results plays an important role in the dialogue between evaluators and managers, in their interaction with the stakeholders of the civil society and in providing dietary advice to the public. The challenges faced by national health authorities in formulating and providing FBDG to the public are recognised in the Terms of Reference as the main reason for updating this guidance document.
The dual nature of RBA (simultaneous assessment of risks and benefits) presents a further challenge in communicating RBA findings. Social science evidence and expertise can help identify and characterise key factors that may underlie these challenges and develop communication strategies to overcome them. They range from cognitive factors (i.e. knowledge, awareness, perceptions), to search behaviors and information processing, as well as to the individual, socioeconomic and environmental characteristics.
Relationship with health claims
Risk assessment for the chemical safety of food is typically performed by toxicologists and aims to identify the highest doses not associated with an adverse effect. Safety/uncertainty factors are then applied to arrive at safe levels for human exposure, resulting in essentially no-effect levels of intake. In contrast, risk-benefit assessment for nutrition is typically performed by nutritionists/epidemiologists, who work with dose levels with clear (beneficial) effects (e.g. minimum effective doses, scientific basis of health claims), i.e. they focus on intake levels that are essentially with effect.
A true risk/benefit assessment therefore requires expressing the risks and benefits of foods and food ingredients in a single currency, thus allowing a qualitative and above all quantitative comparison of the impacts on public health of adverse and beneficial effects.
The level of scientific evidence required to identify the adverse and/or positive health effects of a food compound, food or diet is not consistent. For health claims, a nutritional benefit must be scientifically proven with convincing evidence of a cause-effect relationship, before it can be accepted.
On the other hand, the scientific evidence needed to identify risks or adverse health effects may generally be lower, as often only the indication of a risk is sufficient for scientific justification. If these practices are transferred to risk-benefit analysis, risks are more likely to be included, thus leading to potential bias. It is therefore essential to make a paradigm shift, moving from considering RBA as a sum of risk and benefit assessments to considering RBA as a well-integrated risk and benefit assessment. (5)
Provisional conclusions
Risk-benefit analysis represents an advanced methodological framework to identify the simultaneous presence of risks and benefits related to nutrition (e.g. diet, food, nutrient). Member States have requested the Authority to update the guidelines precisely to facilitate the development of national dietary guidelines, which take into account the risk-benefit duality in the field of food and nutrition.
The complexity of the method is certainly a major obstacle to wide adoption of the methodology, especially in relation to the RBA, which is the fundamental basis for the evaluation by risk managers and implementations at policy level, as well as helping in the evaluation of beneficial effects that are difficult to scientifically validate, such as health claims.
EFSA has funded and initiated several autonomous projects, such as NovRBA, which, as noted above, sought to assess the impact of replacing various foods with insect-based products. The unavailability of data is however insufficient to have reliable estimates, as in the case of alternative scenarios of other cases based on the reference (sub)populations.
Dario Dongo and Andrea Adelmo Della Penna
Footnotes
(1) EFSA (2006) The EFSA’s 6th Scientific Colloquium Report – Risk-benefit analysis of foods: methods and approaches. EFSA Supporting Publications 4(3):116E, https://doi.org/10.2903/sp.efsa.2007.EN-116
(2) DTU. Metrix – Risk-benefit assessment of foods. https://backend.orbit.dtu.dk/ws/portalfiles/portal/203782952/Rapport_Metrix_Risk_benefit_assessment_of_foods.pdf
(3) V. https://cordis.europa.eu/project/id/31731
(4) EFSA Scientific Commitee (2024) Guidance on risk-benefit assessment of foods. EFSA Journal 22:e8875, https://doi.org/10.2903/j.efsa.2024.8875
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
Graduated in Food Technologies and Biotechnologies, qualified food technologist, he follows the research and development area. With particular regard to European research projects (in Horizon 2020, PRIMA) where the FARE division of WIISE Srl, a benefit company, participates.
