“composition-based risk (and benefit) assessment. part ii- exercises” · session :risk and...
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SESSION :Risk and benefit assessment
“Composition -based risk (and benefit) assessment. Part II- Exercises ”
BRAMA training for technicians & authorities – Modul e III, Cairo (19-21 October 2015)
Antonella Guzzon, Hylobates
1. Case study: cinnamon bark essential oil
Open collaboration: the RBA
methodology will be freely
accessible through a web
tool (Opasnet).
Advantage: open for
consultation to experts and
policy makers, transparency
Composition of cinnamon essential oil extracted bysteam distillation
1. Systematic literature search
on Pubmed to integrate data
from European Pharmacopeia and
existing assessments.
2. Selection of articles based on
Inclusion/Exclusion criteria�
Only articles reporting the full
composition were used (11 out of
171)
Composition of cinnamon essential oil extracted bysteam distillation
1. Data on composition were
imported in Opasnet and the on-
line tool applied to estimate
mean, median, range of variation
Composition of cinnamon essential oil extracted bysteam distillation
19 compounds identified
Main compound present:
cinnamaldehyde
Risk assessement :- identification and characterisation of adverse health effects- history of consumption and case reports
Methodology is based on 3 steps:
1. data on adverse health effects were collected from relevant authoritative assessments and integrated with literature search on Pubmed.
2. assessment of all data available on the whole preparation and its individual constituents,
3. health guidance values, reference doses and threshold of toxicological concern were used to focus the assessment on compounds that are not unlikely to pose a risk to health.
Identification and characterisation of adverse health effects
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
4 compound above health guidance valuesCaryophyllene,Cinnamyl acetate,Para-methoxycinnamaldehyde,Safrole
11 compounds above health guidance values2-Carene, Cadinene, Caryophyllene, Cinnamaldehyde, Cinnamyl acetate, Para-methoxycinnamaldehyde, Safrole, Trans-2-methoxycinnamaldehyde, Z-cinnamaldehyde, Alpha-copaene, Alpha-muurolene
Lowest intake of essential oil:50 mg/day
Highest intake of essential oil:200 mg/day
Identification and characterisation of adverse health effects
Case reports of adverse effects
23 reported adverse cases:
majority due to the consumption
(chronic use) of chewing-gums
and cosmetics.
Few cases for food supplements.
Case reports of adverse effects
EMA reported oral mucosal
inflammation and lesions following
consumption of cinnamon flavored
chewing gums.
Effects reported were not severe and
reversible.
Likelihood of adverse effects from
cinnamon used in food supplement
lower than cinnamon used in chewing
gums or cosmetics.
No human studies available that
might have detected adverse events.
Vienna – 5th Project Meeting- May 13th 2014
BRASOV PROJECT MEETINGS - MAY 2011
Beneficial effects of cinnamon
essential oil were identified
based on benefits indicated in
the Italian list of approved plants
and acknowledeged by EFSA as
physiological beneficial effects
Benefit assessement
Vienna – 5th Project Meeting- May 13th 2014Vienna – 5th Project Meeting- May 13th 2014
Benefit assessement
Reduction of flatulence and bloatingData from traditon of use and in vitro studiesNon data from in vivo animal studies or human studies
Benefit assessement
Maintenance of normal blood glucose concentrationData from traditon of use, in vitro studies, in vivo animal studies . No data from human studies.
Evaluation of quality and strength of the evidence
based on WHO approach (2003) modified considering that forbotanical prearation evidence is available from tradition of use, in vitro, in vivo, human data
Risk and benefit characterisation
Long history of consumption. Unlinkely sever and non-reversible acute
adverse effects.Additional toxicological data would be required for some
compounds to reduce uncertainty.
Considerable uncertainty on the benefits. Tradition is convincing while there
is imited in vitro and in vivo evidence, no human data
Benefits are unlikely to outweigh risks. Risks are expected to be low, but
uncertainty exist (safrole levels, extent of chronic consumption, maximum
intake levels)
1. Literature data data on
composition were collected and
imported in Opasnet and tool
applied to estimate mean,
median, range of variation
2. Case study: bitter fennel, dried seeds, essential oil
Composition of fennel dried fruits essential oil
Main compounds found:
Trans-anethole
Eugenol
Estragole
Almost all the compounds were present in concentration below the related health guidance values or toxicological threshold of concern except for apiole and estragole. Estragole in some cases was found in high concentrations� genotoxic compound
Identification and characterisation of adverse health e ffects
Supplements containing fennel essential oil (median intake e.o. 0.28 mg/day)
Supplements containing powdered seeds (median intake 102.25 mg/day)
Various compounds were found:the most abundant were quercitin(9.31%) and bilobalide (2.9%)
3. Case study: Ginkgo biloba, dried leaf extract
� Bilobalide is the onlycompound present inconcentrations higher than thesafety level.
� It might represent a priority forthe risk assessment due toconsumption of Ginkgo biloba.
� Further studies would beneeded to confirm theconcentration of thecompound.
Compos
to
Media Sd Min Q0.025 Median
a
Q0.075 Max
1 Bilobalide 14.06 9.98 0.00 0.00 20.40 21.80 21.80
3. Case study: Ginkgo biloba, dried leaf extract
Overall conclusions
� Integrated approach to risk-benefit assessment of PFSs was developed and applied to case-studies in the Opasnet platform.
� Opasnet: collaborative and transparent approach.
� Assessments structured in different pages corresponding to the steps of the RBA methodology