Benefit-risk assessment of plant-based food supplements

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This page is a Plantlibra deliverable. <section begin=plantlibra />

• Name: DWP5-8 Report on (health) burden of PFS and full risk-benefit assessments and results of validation.
• Deadline: April 2014
• Responsible partner: Hylo
• Status: Drafting of the scope started.

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Benefit-risk assessment of plant-based food supplements looks at the acceptability of several plant-based food supplements (PFS).

Task 5.7 (May 2011 - November 2012): Burden estimates Using information on risks from WP3 (chronic), WP4 (acute) and on intake, PFS-attributable fraction estimates of incident cases of acute or chronic adverse effects will be used to estimate the burden of disease, or of the selected common currency, for the 5-10 leading plants used in food supplements (based on findings of WP1), and compared with other foodborne hazards. The estimates will be produced in the context of the case-studies of task 5.7. Additional estimates will be produced for contaminated PFS, based on data from WP6 (DWP5-8).

Task leader: Hylo PM: Hylo 4, THL 2

TODO: {{#todo:Task 5.7 (May 2011 - November 2012): Burden estimates|Lbucchini|Plantlibra}}

Task 5.8 (July 2011 - March 2014): Application and validation of risk benefit assessment methodology Further case-studies will be explored to evaluate the large-scale applicability of the methodology, with data from the project databases to evaluate its ability to provide the necessary information. At least three risk-benefit assessments, where advanced quantitative modelling is necessary, will be selected based on consumption, public health significance and evidence of overlapping risks and benefits (MWP5-4), and fully developed by THL and Hylo using an Analytica simulation model and an Opasnet risk assessment environment. Task partners will contribute to the open risk assessment process by editing variabiles online. Validation will be conducted on a sample of case-studies according to the methodology of task 5.3, discussed at the last project meeting (MWP5-2) and reported (DWP5-8).

Task leader: Hylo PM: Hylo 7, UMIL 0.5, THL 3, WUR 1

TODO: {{#todo:Task 5.8 (July 2011 - March 2014): Application and validation of risk benefit assessment methodology|Lbucchini|Plantlibra}}

Scope

Purpose

• What administrative actions are warranted related to the PFSs, given the information in the assessment?
  • Are the benefits of each PFS so large compared with possible risks that they can be kept in the market?
  • Is there a need for restrictions or guidance?
• Which health claims of each PFS are scientifically supported?

Boundaries

Plants considered (based on Plantlibra Description of work, Annex 2, and Ginkgo biloba from Annex 1):

Latin name	Common name	Active compounds	Main reported risks
Artemisia dracunculus/sativa	Tarragon	Alkylbenzenes	Genotoxicity
Borago officinalis	Borage	Pyrrolizidine alkaloids	Hepatotoxicity (misidentification)
Camelia sinensis	Green tea	Cathechins/epatotoxicity	Hepatotoxicity
Cinnamomun zeylanicum	Cinnamon	Coumarin	Genotoxicity
Echinacea purpurea	Purple coneflower	Several compounds	Teratogenesis
Foeniculum vulgare	Fennel	Alkylbenzenes	Genotoxicity
Heliotropium spp	Heliotropes	Pyrrolizidine alkaloids	Hepatotoxicity (misidentification)
Ocimun basilicum	Sweet Basil	Alkylbenzenes	Genotoxicity
Pimpinella anisum	Anise	Alkylbenzenes	Genotoxicity
Ginkgo biloba L.	Maidenhair tree	Ginkgolides

⇤--1: . We should look at specific products instead of specific plants. --Jouni 19:09, 5 June 2010 (UTC) (type: truth; paradigms: science: attack)

⇤--2: . We should look at specific chemical compounds. --Jouni 19:09, 5 June 2010 (UTC) (type: truth; paradigms: science: attack)

----#: . The assessment should be at plant level as well as product level. Plants and products are the regulatory units. Compounds as such are not regulated, unless they are used as pure extracts. They may be part of the assessment, but compounds cannot be the focus of the assessment. As for products, they are less important than plants in terms of regulation. --Lbucchini 10:30, 7 June 2010 (UTC) (type: truth; paradigms: science: comment)

Other boundaries:

• Time: Current situation
• Spatial: European Union
• Target population: People who use these products.
• Products: All products marketed as food supplements and containing compounds from the list above.
• Endpoints: All relevant health endpoints.

Intended use and users

The assessment aims to produce relevant information for national and European administrators (especially EFSA) as a basis for regulatory decisions about the products considered.

Participants

This is an open assessment. Anyone can participate. (If you want to edit the content, you must get a user account in Opasnet. Commenting is possible without registering.)

Scenarios

• BAU: Current use.
• Reference: Situation after relevant administrative actions (to be defined below in section Definition).

Definition

Indicators (outcome variables)

• Health benefits of plant-based food supplements
• Health risks of plant-based food supplements
• Willingness to use plant-based food supplements

Decision variables

• Administrative actions related to plant-based food supplements

Other variables

• Consumption of plant-based food supplements in Europe
• Moral norms for decisions about different consumer products
  • Utilitarian approach: Decisions should be made based on the overall average net (i.e., benefit+risk) impact, not on impacts on individual people.
  • Risk-based approach: If there is a risk, the product is not acceptable.
  • Mixed approach: Risks are more important than benefits, but they should be measured with a single currency.
  • Egalitarian approach: Impacts on the most vulnerable or most affected should be used as the basis for decisions.
• ERF of plant-based food supplements on health
• Inertia as a means to reduce adverse impacts of changes

Related files

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