View source for Benefit-risk assessment of plant-based food supplements

[[Category:Plantlibra]]
[[Category:Plantlibra deliverables]]
[[Category:Food supplements]]
{{assessment|moderator=Jouni}}

'''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.
<section end=plantlibra />

'''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|Task 5.7 (May 2011 - November 2012): Burden estimates|Lbucchini|project=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|Task 5.8 (July 2011 - March 2014): Application and validation of risk benefit assessment methodology|Lbucchini|project=Plantlibra}}

==Scope==

===Purpose===

* What administrative actions are warranted related to the [[PFS]]s, 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):

{| {{prettytable}}
!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 || 
|}      

{{attack|1|We should look at specific products instead of specific plants.|--[[User:Jouni|Jouni]] 19:09, 5 June 2010 (UTC)}}

{{attack|2|We should look at specific chemical compounds.|--[[User:Jouni|Jouni]] 19:09, 5 June 2010 (UTC)}}

'''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 [[variable]]s)===

* [[Health benefits of plant-based food supplements]]
* [[Health risks of plant-based food supplements]]
* [[Willingness to use plant-based food supplements]]

===Decision [[variable]]s===

* [[Administrative actions related to plant-based food supplements]]

===Other [[variable]]s===

* [[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]]
	
==Result==

===Results===

===Conclusions===

==See also==

==References==

<references/>

==Related files==

{{mfiles}}