Difference between revisions of "Benefit-risk assessment of food supplements"

Revision as of 05:36, 4 June 2010

Risk-benefit assessment for food supplements is a method about making assessments for plant-based food supplements (PFS).^[1]

This page is a Plantlibra deliverable (see all). <section begin=plantlibra />

• Name: DWP5-1 Risk-benefit methodologies
• Responsible partner: THL, Jouni
• Deadline: June 2011
• Status: Scoping started

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Scope

What is a good method for making benefit-risk assessments for plant-based food supplements such that it has the following properties?

• The valuations and expectations are in line with what a typical user of PFS would think (i.e., if a PFS BRA and its conclusions are explained to a typical user, the user is not negatively surprised about what was done).
• It offers a clear guidance for a relevant authority to perform a PFS BRA in practice.
• It offers a clear guidance for a relevant authority to evaluate nutrition and health claims of a PFS.
• The method is coherent with the methods used for the neighbouring areas, namely foods and medicine, especially with borderline products.

How is the method validated?

Definition

Based on findings reported in the review (DWP5-1) and a preliminary conceptual workshop held at the kick-off meeting (MWP5-1), a risk-benefit assessment methodology will be proposed and tested in selected case-studies. The methodology, to be developed in Opasnet, should be organized in tiers, allowing to identify risk-benefit scenarios and to address qualitatively scenarios (e.g., through MOE, ADI) where risks or benefits are not overlapping. After preliminary testing of the methodology on at least 5 case-studies drawn from the PlantLIBRA list of case-studies, the report will be submitted for review to partners and to the three advisory boards; their feedback will be discussed, aligned with outcomes of WP2 (benefits, specifically definition of benefits and integration of various types of evidence), WP3 (risks and new approaches for risk assessment) and WP4 (acute risks, specifically epidemiological evidence), and integrated at the second project meeting. Uncertainty will be described and estimated when possible. The final report will be published alongside with a generic Analytica software tool to explore risk and benefits (DWP5-1).

Task leader: THL

PM: THL 5, Hylo 3, UMIL 0.5

A review of the concepts of validation and fit-for-purpose in the field of risk, benefit and risk- benefit assessment will be conducted by Hylo in peer-reviewed literature and reported (DWP5- 1). Following review by partners and advisory boards, a protocol with requirements to assess fit-for-purpose and to validate (potentially against unused data-sets) the different assessment methodologies will be prepared using the Opasnet platform and reported by THL (MWP5-2).

Task leader: THL

PM: THL 6, Hylo 3

Safety factor thinking would lead to bizarre outcomes with benefits. For risks, the question is: "Taken into account human variability, what is a dose where we can be sure that there is no risk?" Then we apply a safety factor, e.g. divide a NOAEL with 10. But with benefits, using the same logic, we should ask: "Taken into account human variability, what is a dose where we can be sure that there is no benefit?" Although the question is logical, we have no use whatsoever for the answer. Instead, if we ask: "...what is a dose where we can be sure that there IS benefit?", then we must confess that there is no such number that we could use to multiply a dose; many compounds simply do not have any benefit, whatever the dose.

The working conclusion is that for a coherent BRA method, safety factors should not be used at all.

Result

Suggested methods:

• Margin of exposure (MOE)
• Acceptable daily intake (ADI)
• Quantitative benefit-risk assessment

See also

• Margin of exposure for selected food supplements
• State of the art of environmental health assessments

References

Related files

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