EFSA: Guidance on human health risk-benefit assessment of foods
SCIENTIFIC OPINION
Guidance on human health risk-benefit assessment of foods
EFSA Scientific Committee
European Food Safety Authority (EFSA), Parma, Italy
Contents
Abstract
The Scientific Committee of the European Food Safety Authority (EFSA) developed guidance for performing risk-benefit assessments of food. The document focuses on human health risks and human health benefits, and does not address social, economic and other considerations such as “cost-effectiveness” considerations. It is considered as essential that formulation of the problem precedes the risk-benefit assessment as such. Agreement between the risk-benefit assessor and the risk-benefit manager on the terms of reference should be reached in order to ensure that the outcome of the assessment is useful and relevant for the risk-benefit manager goals. A stepwise approach is recommended for the risk-benefit assessment, i.e. i) initial assessment, addressing the question whether the health risks clearly outweigh the health benefits or vice versa, ii) refined assessment, aiming at providing semi-quantitative or quantitative estimates of risks and benefits at relevant exposure by using common metrics, and iii) comparison of risks and benefits using a composite metric such as DALYs or QALYs to express the outcome of the risk-benefit assessment as a single net health impact value. The outcome of each step of the assessment should also include a narrative of the strengths and weaknesses of the evidence base and its associated uncertainties. After each step of the risk-benefit assessment, discussion should take place between the risk-benefit assessor and the risk-benefit manager on whether sufficient information has been provided or whether the terms of reference should be refined in order to proceed with the next step of the assessment. Two examples (selenium as an indispensable nutrient, and fish consumption) illustrate the proposed approach for risk-benefit assessment.
Summary
The European Food Safety Authority (EFSA) asked its Scientific Committee to prepare a guidance document for performing risk-benefit assessments of food related to human health risks and human health benefits.
Risk-benefit assessments are performed in different disciplines, under various perspectives and use a wide range of quantitative or semi-quantitative tools. In this opinion, guidance for performing riskbenefit assessments of food focuses on human health risks and human health benefits and does not address social, economic and other considerations such as “cost-effectiveness” considerations. The Scientific Committee notes that there is less experience with benefit assessment than with risk assessment and therefore proposes to mirror the risk assessment paradigm by introducing four steps for the benefit assessment, i.e. positive health effect identification, positive health effect characterisation (dose response assessment), exposure assessment and benefit characterisation. Following this approach will facilitate a transparent comparison of risks and benefits in the riskbenefit assessment.
Problem formulation should precede the risk-benefit assessment. Agreement on the terms of reference between the risk-benefit assessor and the risk-benefit manager is critical for ensuring a useful and relevant outcome for the risk-benefit manager goals.
After problem formulation, a stepwise approach is recommended using three steps: i) initial assessment, addressing the question whether the health risks far outweigh the health benefits or vice versa, ii) refined assessment, aiming at providing semi-quantitative or quantitative estimates of risks and benefits at relevant exposure by using common metrics, and iii) comparison of risks and benefits using a composite metric such as DALYs or QALYs to express the outcome of the risk-benefit assessment as a single net health impact value. At each of the three steps, both risk assessment and benefit assessment are usually performed at the population level. Where differences in the sensitivity to the agent under consideration exist or are assumed to exist in specific subpopulations, separate consideration of these subpopulations is needed.
After each step of the risk-benefit assessment, discussion should take place between the risk-benefit assessor and the risk-benefit manager on whether sufficient information has been provided or whether the terms of reference should be refined in order to proceed with the next step of the assessment. The outcome of each step of the assessment should also include a narrative of the strengths and weaknesses of the evidence base and its associated uncertainties. The overall magnitude of uncertainty associated with a risk-benefit assessment may often be large. This should not be regarded as implying a failure of the assessment; on the contrary, it provides essential information for decision-making and helps in identification of data needs.
A number of metrics which can be used in the risk-benefit assessment are described in the document. It should be noted that more than one metric will be needed to capture all dimensions of health for a risk-benefit assessment. It is important that the risk-benefit manager is aware of the limitations of the metrics used for measuring risks and benefits.
The Scientific Committee recommends that metrics used in risk-benefit assessment and weight factors associated to most common diseases should be internationally agreed upon in order to ensure harmonisation and recognition of the assessments.
The Scientific Committee recommends a close collaboration between risk assessors and benefit assessors in order to ensure that data generated by one or the other can be used in a broader riskbenefit assessment context. Furthermore, the development of hard biomarkers of effect for both risk and benefit is also needed.
Two examples of the approach for risk-benefit assessment are given. The first one (selenium, an indispensable nutrient) illustrates the case where the risk and the benefit are associated with one single agent, while in the second example (fish), the risk is due to one selected contaminant in food (methylmercury), whilst the benefit is due to other food components. The examples highlight the complexity of risk-benefit assessment, already when entering the first steps of the assessment.
Background as provided by EFSA
Where a food or food substance is recognised to have the potential to exert both health benefits and health risks it is important for risk-benefit managers to be able to weigh the risks against the benefits on the basis of a qualitative or quantitative risk-benefit assessment. However, there is currently no agreement on general principles or approaches for conducting a risk-benefit analysis for food and the assessment of risk to human health of food substances or nutrients is usually conducted independently of possible health benefits.
EFSA organised a scientific colloquium on risk-benefit analysis of foods in July 2006 to have an open scientific debate on the methods and approaches for risk-benefit analysis of foods4. There was a general consensus that a risk-benefit analysis should mirror the approach already agreed upon in the risk analysis, namely consist of a risk-benefit assessment part, a risk-benefit management part, and a riskbenefit communication part. The risk-benefit assessment should be comprised of 3 elements, i.e. risk assessment, benefit assessment and risk-benefit comparison. As for the risk assessment paradigm which is well established, the benefit assessment should also include the following steps: positive health effect identification, positive health effect characterisation (dose-response assessment), exposure assessment, and benefit characterisation. Finally the risk-benefit comparison should contain a means, quantitative if possible, to compare/weigh the potential human health risks against the potential human health benefits. For this a common scale of measurement (“composite metric”) for the risk and the benefit would facilitate the communication of the results.
It is considered that the decision to initiate a risk-benefit analysis would best be made on a case-by-case basis and, given the resources required to carry out such an analysis, should only be undertaken when clearly needed. Therefore the formulation of the problem (“why is the risk-benefit analysis being done, why do we need it?”) is pivotal; furthermore, it is emphasised that the question asked by the risk-benefit manager to the risk-benefit assessor should be clearly understandable.
Regarding tools/data available or needed to quantify the human health risks and health benefits it is considered that tools for classification of risks and of benefits would need to be developed, together with tools for comparison and prioritisation of risks and benefits. Both tools and data should be available, together with a common scale of measurement for risk and benefit. In order to provide confidence in the outcome of a risk-benefit assessment, the assumptions made for the assessment as well as the uncertainties embedded in the outcome should be stated explicitly.
It has been proposed at the EFSA Scientific Colloquium4 that the “state-of-the-art” of risk-benefit assessment had advanced beyond the brainstorming stage and that it was now time to advance to the ”learning by doing” stage. Although it may be premature at present to develop a prescriptive framework for risk-benefit assessment, it is suggested that a guidance document should be developed with respect to methodology, approaches, tools and potential limitations in the risk-benefit assessment.
Terms of reference as provided by EFSA
EFSA requests the Scientific Committee to prepare a guidance document for performing risk-benefit assessments of food related to human health risks and human health benefits. To this end the document should give considerations to the following issues:
- Scope and objective of risk-benefit assessment;
- Identification of situations for which a risk-benefit assessment might be appropriate;
- Guidance on problem formulation particularly considering the type of risk-benefit analysis
needed;
- Development of a harmonised language to express risk and benefits;
- Usefulness of currently available toxicological, epidemiological and nutritional data to assess
risk-benefit;
- Consideration of methods and approaches needed to assess the risks and benefits and to
compare them, e.g. common scale of measurement for the comparison of human health risks and health benefits;
- Considerations on how animal and other data can be extrapolated to the human situation in
order to facilitate human risk-benefit comparison;
- Identification of potential limitations of any risk-benefit assessment;
- Ongoing research activities, such as DG RTD projects and activities undertaken by other
organisations in order to join efforts and aim at harmonised approaches for risk-benefit assessment;
- Recommendations on future initiatives to overcome current limitations.
Assessment
Introduction
In July 2006, EFSA organised a scientific colloquium on risk-benefit analysis of foods, during which it was proposed that the “state-of-the-art” of risk-benefit assessment had advanced beyond the brainstorming stage (van Kreijl et al., 2004) and that it was now time to advance to the “learning by doing” stage. Although it may be premature to develop a prescriptive framework for risk-benefit assessment, it was suggested that a guidance document should be developed with respect to methodology, approaches, tools and potential limitations in the risk-benefit assessment. Since then, several activities such as the Beneris, Qalibra, Brafo and Bepraribean projects, which EFSA has been following closely, have been commenced to address the issue of risk-benefit assessment. In February 2010, the EFSA Scientific Committee endorsed the draft guidance on “human health riskbenefit assessment of foods” for a 6-week public consultation. The 280 comments received from 19 interested parties were considered in April 2010 for finalising the present guidance document (EFSA, 2010).
Risk-benefit assessments are performed in different disciplines, under various perspectives (government, industry, patients) and using a wide range of quantitative and semi-quantitative tools. Examples are human medicine (e.g. assessment of the benefits and risks in the context of a new drug application) and engineering. Many of such assessments include socioeconomic considerations or aspects beyond human health that are not directly comparable and require value judgments to be compared.
The classic case where value judgments are needed is when the risk or benefit assessment is used as the basis of a cost-benefit analysis. In this case risks and benefits are given monetary values reflecting market prices directly or indirectly. The use of economic methods such as willingness to pay studies or co-joint analyses could be helpful in eliciting information on the consumer or citizen preferences and valuing the benefits and risks. The direct and indirect monetary costs of years of life lost through, and years of life spent with diet-related diseases, like cardiovascular diseases or cancer can be calculated based on morbidity and mortality statistics. The EFSA’s Scientific Committee, given EFSA’s remit, excluded social, economic and other considerations such as “cost-effectiveness” from its considerations. In this opinion, guidance for performing risk-benefit assessments of food related to human health risks and human health benefits is provided. The result of such an assessment will enable risk-benefit managers to take decisions and to formulate a strategy, taking into account other considerations such as social, economic or “cost-effectiveness” aspects.
Risk assessment - Definition
Risk assessment is “a process intended to calculate or estimate the risk to a given (sub)population, including the identification of attendant uncertainties, relating to exposure to a particular agent, taking into account the inherent characteristics of the agent of concern as well as the characteristics of the specific target system” (IPCS, 2004). For the purpose of this opinion the agent will be a food itself or a constituent of a food (incl. contaminants, microbes), and the target system is the human body.
Key words
Risk, benefit, assessment, problem formulation, risk-benefit assessment paradigm, stepwise approach, metrics
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