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. 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: – intake comp (mg /kg /d) = intake (g /d) * conc comp (mg /g) / 60 (kg) – concern indicator comp,i = intake comp (mg /kg /d) / guidance value comp,i (mg /kg /d) * safety factor i 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) – BMDL 10 (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