Was that milk warm or cold, pasteurised or raw? Was that piece of fish full of healthy omega-3s or laced with mercury? How about that folic acid, how much is beneficial and how much is risky? Just how do you weigh the benefits and risks of food?
Weighing the Need: Background & Study
Optimal nutrition plays an important role in disease prevention making the analysis of the benefits and risks of food imperative for public health. Considerable disparity exists in the assessment of the benefits and risks of foods, with recommendations often relying on subjective judgements. Therefore, there exists a need for a common strategy for the assessment of food benefits and risks. Introducing BRAFO – Benefit-Risk Analysis of Foods – a European Commission Specific Support Action to investigate the benefit-risk analysis of foods.
Coordinated by the International Life Sciences Institute (ILSI) Europe and funded by the European Commission, BRAFO seeks to develop a common framework for comparing health benefits and risks of food and food components (i.e., specific nutrients or chemicals). One of the goals is to create a stronger scientific base for communication of benefits and risks to policy makers, including appropriate expression of uncertainty throughout the European Union (EU).
BRAFO follows a series of European Commission benefit-risk assessment studies – FOSIE (Food Safety in Europe: Risk Assessment of Chemicals in Food), PASSCLAIM (Process for the Assessment of Scientific Support for Claims on Foods), QALIBRA (Quality of Life - integrated Benefit and Risk Assessment), BEPRARIBEAN (Best Practices in Risk-Benefit Analysis) – and narrows in on how best to assess foods and food components. Currently in its third and final year, the BRAFO study was designed with three components: methodology (year 1), case study (year 2), and consensus (year 3).
Building the Model: Methodology Component
In September 2007, BRAFO created a European network to compile expert methodologies for benefit-risk analysis from several disciplines including risk assessment, nutrition, benefit-risk analysis, and included collaborators from academia, regulatory agencies, and the food industry. Most classical methodologies for benefit or risk analysis examine benefits and risks separately; however, BRAFO integrates both benefits and risks when determining net health impacts of food (ingredients).
After reviewing current methodologies for benefit or risk analysis, researchers developed a paradigm for performing benefit-risk assessments of food.1 The model is based on a tiered approach, and where needed compares benefits and risks using a common metric such as quality adjusted life years (QALY) and disability adjusted life years (DALY). The tiered approach starts with pre-assessment and problem formulation to set the scope of the assessment and comprises four tiers. The tiers differ principally in the way benefits and risks are integrated. At Tier 1, benefits and risks are assessed separately, while in Tiers 2–4 they are integrated using increasingly sophisticated approaches generating a measure of net health impact.
Testing the Model – Case Study Component
After the BRAFO methodology was designed, based on the above mentioned tiered approach, the second year of BRAFO focused on testing such methodologies using case studies on three food topics: natural foods (fish, soy), dietary interventions, and heat processing of food. Case studies on natural foods weighed the benefits of components in fish such as omega-3 fatty acids, with the risks from components such as mercury. Case studies on dietary interventions applied the benefit-risk model to benefits and risks from different exposure levels; for example, beneficial versus potentially adverse levels of folic acid fortification. Finally, case studies on heat processing of foods applied the benefit-risk model to measure net health impacts of this type of food processing.
Implementing the Model: Consensus Component
BRAFO’s final stage is to review the applicability of the methodology to the different case studies, and to develop a consensus on a revised BRAFO methodology. Afterwards, the project results will be disseminated to academic scientists, industry, consumer organisations and regulators. Findings from BRAFO will feed into another EU project, FoodRisC, which aims to produce a toolkit and practical guidance that target and tailor coherent food benefit and risk messages to consumers across Europe.
While the BRAFO project is still ongoing, the European Food Safety Authority (EFSA) has issued a guidance document on human health risk-benefit assessment of foods, to help risk assessors accomplish their challenging task.2 This document takes into account results from BRAFO and other EU projects mentioned above that deal with benefit and risk assessment of foods.
EU project Benefit-Risk Assessment of Foods (BRAFO) - www.brafo.org
EU project Process for the Assessment of Scientific Support for Claims on Foods (PASSCLAIM) - http://www.ilsi.org/Europe/Pages/PASSCLAIM_Pubs.aspx
EU project Food Safety in Europe: Risk Assessment of Chemicals in Food (FOSIE) - http://www.ilsi.org/Europe/Pages/FOSIE.aspx
EU project Quality of Life - integrated Benefit and Risk Assessment (QALIBRA) - http://www.qalibra.eu/
EU project Food Risk Communication (FoodRisC) - www.eufic.org/article/en/show/eu-initiatives/rid/foodrisc/
EU Safefood era project Best Practices in Risk-Benefit Analysis (BEPRARIBEAN) - http://en.opasnet.org/w/Bepraribean
- Hoekstra J et al. BRAFO tiered approach for benefit-risk assessment of foods. Food Chemical Toxicology (2010). doi:10.1016/j.fct.2010.05.049
- European Food Safety Authority (2010). SCIENTIFIC OPINION - Guidance on human health risk-benefit assessment of foods. EFSA Journal 8(7):1673. Available at: http://www.efsa.europa.eu/en/scdocs/doc/1673.pdf