WP 5: Progress on tasks 5.2, 5.3 and 5.4

1. WP 5: Progress on tasks 5.2, 5.3 and 5.4 Olli Leino THL

2. Tasks 5.2: Tiered methodology for risk benefit assessment 5.3: Review on available Methodology for validation of risk, benefit and risk- benefit assessment 5.4: Identification of common currency http://en.opasnet.org/w/Opasnet http://en.opasnet.org/w/Benefit-risk_assessment_of_plant-based_food_supplements

3. Task 5.2 description 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 Mediawiki, 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 plants, the report will be submitted for review to partners and to the three advisory boards; their feedback will be discussed, aligned with preliminary outcomes of WP2 (benefits, specifically definition of benefits and integration of various types of evidence), WP3 (risks and other approaches for risk assessment already available), 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). http://en.opasnet.org/w/Opasnet http://en.opasnet.org/w/Benefit-risk_assessment_of_plant-based_food_supplements

4. Task 5.2 description 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 Mediawiki, 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 plants, the report will be submitted for review to partners and to the three advisory boards; their feedback will be discussed, aligned with preliminary outcomes of WP2 (benefits, specifically definition of benefits and integration of various types of evidence), WP3 (risks and other approaches for risk assessment already available), 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). http://en.opasnet.org/w/Opasnet http://en.opasnet.org/w/Benefit-risk_assessment_of_plant-based_food_supplements

5. Case studies Suggested case-studies: • Bilberry • Ginkgo • Ginseng • Cinnamon • Sea buckthorn http://en.opasnet.org/w/Benefit-risk_assessment_of_food_supplements

6. Case studies: screenshot http://en.opasnet.org/w/Benefit-risk_assessment_of_food_supplements

7. Task 5.2 description 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 Mediawiki, 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 plants, the report will be submitted for review to partners and to the three advisory boards; their feedback will be discussed, aligned with preliminary outcomes of WP2 (benefits, specifically definition of benefits and integration of various types of evidence), WP3 (risks and other approaches for risk assessment already available), 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). http://en.opasnet.org/w/Opasnet http://en.opasnet.org/w/Benefit-risk_assessment_of_plant-based_food_supplements

8. Task 5.2 description 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 Mediawiki, 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 plants, the report will be submitted for review to partners and to the three advisory boards; their feedback will be discussed, aligned with preliminary outcomes of WP2 (benefits, specifically definition of benefits and integration of various types of evidence), WP3 (risks and other approaches for risk assessment already available), 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). http://en.opasnet.org/w/Opasnet http://en.opasnet.org/w/Benefit-risk_assessment_of_plant-based_food_supplements

9. Risk-benefit assessment methodology organized in tiers • Tier I: Definition of the use purpose and scope of an assessment • Tier II: Definition of the decision criteria • Tier III: Information production

10. Tiered approach: screenshot http://en.opasnet.org/w/Benefit-risk_assessment_of_food_supplements

11. Task 5.3 description 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 a Mediawiki platform and reported by THL (MWP5-2). http://en.opasnet.org/w/Opasnet http://en.opasnet.org/w/Benefit-risk_assessment_of_plant-based_food_supplements

12. Task 5.3 description 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 a Mediawiki platform and reported by THL (MWP5-2). http://en.opasnet.org/w/Opasnet http://en.opasnet.org/w/Benefit-risk_assessment_of_plant-based_food_supplements

13. Validating different assessment methodologies • BEPRARIBEAN project meeting in May 30th in Maastrict, THL (Mikko Pohjola) • Six scientific review articles on the state-of-the-art of benefit-risk analysis in the fields of: • food microbiology • economics and marketing-finance • environmental health (THL) • Medicine • consumer perception • Manuscripts revised and resubmitted to journal in May • After final acceptance, the information will be openly available BEPRARIBEAN = Best Practices for Risk Benefit Analysis of Foods http://en.opasnet.org/w/Bepraribean

14. Task 5.4 description The identification of the common currency (e.g., QALYs, DALYs) will be informed by the review of task 1 (approaches used and applicability to PFS) by the conceptual definition of benefit of WP2 (T2.2) and in consultation with advisory boards. Measurement of benefits that do not involve reduction of disease risk (e.g., enhanced attention due to caffeine intake) will be achieved through a review of the literature and based on results of WP8 (consumers). Two alternative common currencies will be tested in at least one case study of task 5.2 and submitted to the scientific advisory board for review. The process of identification will be documented in DWP5-1. http://en.opasnet.org/w/Opasnet http://en.opasnet.org/w/Benefit-risk_assessment_of_plant-based_food_supplements

15. Task 5.4 description The identification of the common currency (e.g., QALYs, DALYs) will be informed by the review of task 1 (approaches used and applicability to PFS) by the conceptual definition of benefit of WP2 (T2.2) and in consultation with advisory boards. Measurement of benefits that do not involve reduction of disease risk (e.g., enhanced attention due to caffeine intake) will be achieved through a review of the literature and based on results of WP8 (consumers). Two alternative common currencies will be tested in at least one case study of task 5.2 and submitted to the scientific advisory board for review. The process of identification will be documented in DWP5-1. http://en.opasnet.org/w/Opasnet http://en.opasnet.org/w/Benefit-risk_assessment_of_plant-based_food_supplements

16. Demonstration of task 5.4 1) The wikipage (disability weights) above contains an embedded R-software code 2) Source data on the page ”disability weights” is automatically stored in Opasnet base (data base of Opasnet) 3) ”disability weights” can be used together with other information on Opasnet pages to calculate desired results - e.g. Lung cancer cases due to Radon in Europe & disability weights = disability adjusted lifeyears due to Radon in Europe http://en.opasnet.org/w/Disability_weights http://en.opasnet.org/w/Lung_cancer_cases_due_to_radon_in_Europe

17. http://en.opasnet.org/w/Opasnet http://en.opasnet.org/w/Benefit-risk_assessment_of_plant-based_food_supplements