BRAFO, Benefit-Risk Analysis for Foods, was a European Commission
project funded within Framework Six as a Specific Support Action and
coordinated by ILSI Europe. BRAFO developed a tiered methodology for
assessing the benefits and risks of foods and food components, utilising
a quantitative, common scale for health assessment in higher tiers. This
manuscript reports on the implications of the experience gained during
the development of the project for the further improvement of
benefit-risk assessment methodology. It was concluded that the
methodology proposed is applicable to a range of situations and that it
does help in optimising resource utilisation through early
identification of those benefit-risk questions where benefit clearly
outweighs risk or vice versa. However, higher tier assessments are
complex and demanding of time and resources, emphasising the need for
prioritisation. Areas identified as requiring further development to
improve the utility of benefit-risk assessment include health weights
for different populations and endpoints where they do not currently
exist, extrapolation of effects from studies in animals to humans, use
of in vitro data in benefit-risk assessments, and biomarkers of early
effect and how these would be used in a quantitative assessment. (C)
2012 ILSI Europe. Published by Elsevier Ltd. All rights reserved