WP5: Database interface for risk-benefit assessment

Antonella Guzzon, Luca Bucchini (Hylobates).

Jouni Tuomisto (THL).

Overview

• Background• Objectives of the work• Compound intake estimator• Developmental needs• Conclusions

Background

• Need for safe use of plant food supplements.• Science-based understanding and decision-

making is the key.– Regulators– Food chain operators– Customers.

• Quality-assured tools and data banks are needed.

Objectives

• To develop an Internet-based interface where users can access, combine, by plant and compound, and discuss information for risk-benefit assessment.

• To make selected case-studies available to the public through Opasnet web workspace.

• To develop guidance for conducting risk-benefit assessments of plants, extracts, preparations and individual products online.

The product: Compound intake estimator

• An online tool for estimating concentrations and intakes of various compounds in a PFS product.

• http://en.opasnet.org/w/Compound_intake_estimator

• Some data comes from ePlantLIBRA database.• The user may add own data for own

calculations.

Products covered

• Currently, the compound intake estimator contains information about these PFSs:– Cinnamon dried bark essential oil– Bitter fennel essential oil– Fennel fruit– Green tea leaf– Ginkgo leaf– St John’s wort

User interface

• Fill in form.• Click and run

model.• See code if

interested.• Default values

produce a plausible outcome.

Intake calculations

• These equations are used to calculate intakes and level of concern:– intakecomp (mg /kg /d) = intake (g /d) * conccomp (mg

/g) / 60 (kg)– concern indicatorcomp,i = intakecomp (mg /kg /d) /

guidance valuecomp,i (mg /kg /d) * safety factori

• comp = index for compounds• i = index for indicators

Interface for compound concentrations

Results: compounds in cinnamon

Results: intake concerns

Existing data in the tool: guidance values

Guidance values used• In the order of preference:– ADI (acceptable daily intake)– TDI (tolerable daily intake)– BMDL10 (lower confidence interval for benchmark

dose 10• This is often used to calculate MOE = margin of

exposure

– TTC (threshold for toxicological concern) • Based on Cramer classes

Existing data in the tool: product data

Model specifications• Probabilistic model using R statistical software.• The model is on and can be run from a web page in

Opasnet. (MediaWiki)• Data comes from a database that has an interface on

Opasnet page. (MongoDB)• The model code can be copied and run on own

computer. (requires R package OpasnetUtils from CRAN)

• Discussions about the results are possible on the same webpage.

• Opasnet will be maintained by THL, where it is being actively used by several projects.

Development needs

• Guidance value data for new compounds would make the tool more versatile.

• Concentration data exists so far only for PlantLIBRA case products.– However, EFSA has collected data of hundreds of food

supplements from 8 countries. This is a potentially useful data source.

• Currently the concentration data is not publicly available. Opening the data would increase the usability of the tool.

Conclusions

• Compound intake estimator is a usable tool for increasing understanding of risks and benefits of food supplements.

• It offers a platform for shared learning and online discussions.

• However, currently its usability is limited by a fairly small amount of concentration data openly available.

Additional information

• http://en.opasnet.org/w/Compound_intake_estimator • http://en.opasnet.org/w/File:Compound_intake_estimator.ppt• http://en.opasnet.org/w/Plantlibra_deliverable_DWP5-6