Critical appraisal of the assessment of benefits and risks for foods, ‘BRAFO Consensus Working Group’

¿Bueno para la salud? Un análisis de los requisitos de sustanciación científica en la regulación europea de las declaraciones de salud

“…4 Siguiendo las indicaciones de la regulación NHCR, las declaraciones necesitan tener una fundamentación (sustanciación) científica aprobada por la Agencia Europea de Seguridad Alimentaria (EFSA); pero la EFSA no sólo se encarga de las evaluaciones y controles, sino también establece los respectivos criterios metodológicos y mantiene un registro europeo de todas las declaraciones de salud autorizadas y desestimadas. 7,8 Aparte de la sustanciación científica de las declaraciones, la regulación pretende evitar que las declaraciones (etiquetas), tal como aparecen en los envases, confundan o engañen a los consumidores finales. La protección de los consumidores es un objetivo muy destacado de la regulación.…”

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

“…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 generic and can also be applied for microbiological risk assessment, which does not apply animal data.…”

“…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 1 (Fransen et al, 2010;Hoekstra et al, 2012).…”

“…An RBA is multidisciplinary by nature, and may require expertise from not only toxicologists, microbiologists, and nutritionists, but also from epidemiologists, chemists, librarians, statisticians, 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.…”

“…When mirroring risk assessment to benefit assessment, the benefit is 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 "hazard" 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.…”