Plantlibra deliverable DWP5-6

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Deliverable DWP5-6 (Task 5.9)

Number	DWP5-6 (Task 5.9)
Due	M46 (Mar 2014)
Description	Database interface for risk-benefit assessment
Nature	P (Prototype)
Dissemination level	PP (Restricted to project partners and the Commission)
Responsible person	THL

Background and objective of the work

The use of plants and plant derivatives to maintain health has been popular throughout Europe for many centuries. The consumption of teas, digestive drinks, juices, elixirs and extracts prepared from botanicals and used for health maintenance purposes has become part of European cultural heritage. Plant food supplements are a modern-day extension of this process.

PlantLIBRA project (PLANT food supplements: Levels of Intake, Benefit and Risk Assessment) aims to foster the safe use of food supplements containing plants or botanical preparations, by increasing science-based decision-making by regulators and food chain operators. To make informed decisions, competent authorities and food businesses need more quality-assured and accessible information and better tools (e.g. metadata banks).

PlantLIBRA is structured to develop, validate and disseminate data and methodologies for risk and benefit assessment and implement sustainable international cooperation. International cooperation, on-spot and in-language capacity building are necessary to ensure the quality of the plants imported in the EU.

The Description of Work for PlantLIBRA project describes the objective of this deliverable in the following way:

Task 5.9: Integration of databases and guidance

Taking into account the database of WP6, THL will develop an Internet-based interface (DWP5-6) where users can access, combine, by plant and compound, and discuss information for risk-benefit assessment. In this context, THL will make selected case-studies available to the public through the Mediawiki platform, when possible. THL will develop guidance for conducting risk-benefit assessments of plants, extracts, preparations and individual products which will be made available online as Deliverable 5-6 (DWP5-6).

Compound intake estimator

This section describes the open source model Compound intake estimator. The section consists of text that is found on the page Compound intake estimator. This page only shows the subheadings, but the whole text is included in the deliverable submitted. Also a few screenshots are shown.

   1 Question
   2 Answer
       2.1 Compound intakes and risk estimates
       2.2 Compound concentrations
   3 Rationale
       3.1 Guidance values
       3.2 Intake and guidance value calculations
       3.3 User interface
       3.4 Concentrations
       3.5 Data
       3.6 Calculations
       3.7 Extraction techniques
       3.8 Data about guidance values
   4 See also
   5 References

Compound concentration data for PlantLIBRA cases

PlantLIBRA WP5 (HYLO) collected data about compound concentrations in the five case study plants. The methods for the data collection are described elsewhere.

• Cinnamon (dried bark)
• Bitter fennel (fruit)
• Gingko (leaf)
• Green tea (leaf)
• St Johns wort

The data were uploaded to Opasnet database. The database is a versatile data storage for all kinds of data tables related to benefit-risk assessment, health, food, and other topics. It has two parts: an open part that can be accessed using a web browser or through a machine-readable JSON interface; and a password-protected part that is technically similar but is not visible to the Internet.

A large part of the data comes from the ePlantLIBRA database, which was developed in this project. ePlantLIBRA is based on eBASIS from the EuroFIR Network. eBASIS was produced by the EuroFIR network and is now being further developed in a co-operation between the PlantLIBRA Project and EuroFIR AISBL. EuroFIR is funded by the European Commission under the Food Quality and Safety Priority of the FP7 for Research and Technological Development (CT).

eBASIS is a unique database that contains critically evaluated published data on the content and biological effects of bioactive constituents in plant based foods and an up-to-date list of plant and plant part names in 15 EU languages. Bioactive Compounds are defined as inherent non-nutrient constituents of food plants and edible mushrooms with anticipated health promoting, beneficial and/or toxic effects when ingested.

In an early stage there was a plan to store the compound data only in the ePlantlibra database and access that dynamically through a machine-readable interface from Opasnet. However, this plan was abandoned for several reasons. The main reason was that ePlantlibra database is actually only a part of the larger eBASIS database, which contains also proprietary, non-public information. It would have been a large work to build an additional security functionality to allow access to some but not all parts of the database. In addition, the tool we are describing here needs a moderate amount of data, which can easily be copied and uploaded to another system (Opasnet database) for this purpose. And thirdly, when new compound concentration data becomes available (either from ePlantlibra or elsewhere), it is straightforward to upload also the new data to Opasnet database as a part of Compound intake estimator. Thus, the use of Compound intake estimator is not dependent on ePlantlibra database but can benefit from its future development.

Case study results

The following figures demonstrate the user interface and some output graphs from the model. The graphs give a user-friendly way to get an overview of the compounds in a product. It is especially interesting to compare concentrations and levels of concern of different compounds. As can be seen from the pair of graphs of cinnamon dried bark essential oil, most of the product is cinnamaldehyde, which is only marginally above a guidance value and thus not likely a concern. In contrast, safrole seems to be somewhat of concern or at least a compound to pay attention to, as it goes beyond a guidance value by a factor of 10 - 80.

Bitter fennel is a different story. The clearly largest concern is estragole, which goes beyond the BMDL10 by a factor of 50 - 600. Interestingly, it is at the same time one of the two main compounds in the product, implying that the concentration will most likely be high in all bitter fennel products. This product clearly needs a benefit-risk assessment, as the main compound may actually be causing a clear risk, raising the question about the use of this product in the first place. There is also another interesting compound, namely apiole, which goes above the level of concern by a factor of 10 - 200, even when its concentration is so low (0.1 %) that it is not even shown on the graph. With this compound, the first question in mind is whether there is actually evidence supporting its much higher putative potency compared with the other compounds.

Discussion

Concentration and intake data are not easily understood by consumers. There are dozens or hundreds of compounds in a single PFS product. It is therefore very difficult to get any idea which compounds are important and whether a consumer should be interested in further information about these compounds. There is a need for tools visualising these data to promote informed discussion and consumer decisions. The model presented here offers a solution to this need.

This model will make it easy to compare two critical things: exposure to compounds relative to health-based guidance values, and concentrations in the product. By comparing these two graphs, it was possible to identify from each example product two critical compounds that would warrant further scrutiny. The reasons for need of further work were different with each compound, as described in the previous section.

The compound intake estimator model can be used online simply with a web browser. It can easily be copied to other projects or uses in Opasnet. It can also be used on one's own computer, but that requires some skills of R software. It is a small task to add new data sets to the model when they become available. It is open source and thus it can be taken and developed further. It is a part of a large web workspace Opasnet that has several independent users and continuous, long-term maintenance. This flexibility and durability is important when considering the lifespan of the model. Even after the end of the PlantLIBRA project, the model will be maintained and kept available for users.

EFSA data collection and PFS

The critical thing with the compound intake estimator model is the availability of relevant compound concentration data about PFSs. EFSA has recently studied availability of such data. The EFSA contract CFT/EFSA/DCM/2011/03 provided EFSA with an updated food composition database covering approximately 1750 foods in combination with additional FoodEx2 facet descriptors included in the EFSA FoodEx2 classification system. A model for data transfer, compatible with the EuroFIR technical annex and CEN Food Data Standard, and the EFSA data structure was developed and tested. Fourteen national food database compiler organisations supplied initial food lists mapped to the EFSA food list. Eight of them contained data about food supplements and their composition. Datasets compatible with EFSA's data structure were produced based on the models.

Therefore, there exists a large amount of potentially useful PFS compound concentration data in EFSA. However, EFSA has not made this data available for open use, and this will not probably happen before the end of PlantLIBRA project. In any case, it is important to acknowledge and remember this possibility and potential for improvement of the model described here.

Supplement data provided by compilers.

Country	Number of supplements listed
Finland	92
France	449
Italy	126
Netherlands	902
Serbia	8
Slovenia	95
Sweden	122
UK	103

²Does not include supplements for children.

See also

• Compound intake estimator
• heande:Composition of cinnamon dried bark essential oil
• heande:Composition of plant-based food supplements
• heande:Composition of bitter fennel essential oil
• heande:Database interface for risk-benefit assessment