Importance of the use of
appropriate data for dietary
exposure estimations: Inorganic
arsenic as an example
WORLD HEALTH DAY 2015, Lisbon 8th April
Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
EFSA’S ORIGINS
EFSA was established in 2002 as an independent source of
scientific advice on risks associated with the food chain to:
 improve EU food safety
 help ensure a high level of consumer protection
 restore and maintain confidence in the EU food supply
The EFSA is the keystone of European Union risk
assessment regarding food and feed safety.
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Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
FROM RISK ASSESSMENT TO RISK MANAGEMENT
•
In the European food safety system, risk assessment is done
separately from risk management.
RISK
ANALYSIS
Risk
assessment
Risk
management
Risk
communication
•
EFSA operates independently of the community institutions such
as the European Commission and the Parliament.
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Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
OVERVIEW OF WORKFLOW ON SCIENTIFIC OPINIONS
Receipt of request
Preparatory Work
(EFSA Staff, Grants/Contracts)
Working Groups
(Expert Database)
Scientific Panel, Risk
Assessment
Scientific Opinion
Risk managers
Scientific Reports
of EFSA
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Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
FROM RISK ASSESSMENT TO RISK MANAGEMENT
Scientific opinions help Risk Managers (e.g. European
Commission & Member States) to decide the need for
possible revisions of the current legislation and/or any
other possible follow-up actions required in relation to the
presence of contaminants in food and feed
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Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
RISK ASSESSMENT
HAZARD IDENTIFICATION
EXPOSURE ASSESSMENT
HAZARD CHARACTERISATION
Levels in food, dietary
exposure, food consumption,
relevant food groups
ADME, acute/sub-chronic/chronic toxicity,
human data, genotox, reprotox,
mode/mechanism of action, mathematical
modelling (BMD),
derivation of a health based guidance value
RISK CHARACTERIZATION
Relate exposure to Health Based Guidance Value or Margin of exposure (MOE)
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Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
DATA COLLECTION
• EFSA does not have laboratories
• Data are generated in EU Member States and sent to EFSA
Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
DATA COLLECTION: LEGAL FRAMEWORK
Overarching legal obligation:
‘ EFSA shall search for, collect, collate, analyse
and summarise relevant scientific and technical
data …’
‘... work in close cooperation with all organisations
operating in the field of data collection ...’
Article 33 of EFSA Founding Regulation 178/2002/EC
Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
EXPOSURE ASSESSMENT ELEMENTS
Food
consumption
Occurrence
in food
Exposure Assessment
FOODEX LEVEL 1
FOODEX LEVEL 2
FOODEX LEVEL 3
Food
Terminology
Grains and grain-based products
Bread and rolls
Wheat bread and rolls
Wheat bread, white
Wheat bread, white, gluten free
Wheat bread, white, with oil seeds
Wheat bread, brown
Wheat bread, brown, gluten free
Wheat bread, brown, with oil seeds
Wheat bread, with bran
Wheat bread, with oil seeds
Wheat germ bread
FOODEX LEVEL 4
Wheat rolls, white
Wheat rolls, white, gluten free
Wheat rolls, white, with oil seeds
Wheat rolls, brown
Wheat rolls, brown, and oil seeds
Wheat rolls, with oil seeds
Wheat toast bread, white
Wheat toast bread, brown
Wheat bread, gluten free
FOODEX LEVEL 3 Rye bread and rolls
Rye bread, light
Rye bread, light, with oil seeds
Rye bread, wholemeal
Rye bread, wholemeal, with oil seeds
Rye rolls, light
FOODEX LEVEL 4
Rye rolls, light, with oil seeds
Rye rolls, wholemeal
Rye rolls, wholemeal, with oil seeds
Rye toast bread, light
Rye toast bread, wholemeal
FoodEx
classification
Hazard
Appropriate level of
details!
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Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
EXPOSURE ASSESSMENT ELEMENTS
Occurrence
in food
Food
consumption
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Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
DATA STANDARDISATION

Standard Sample Description (SSD)

EFSA standard for receipt of analytical occurrence data
Pre-SSD
 No specified format
 Word / PDF files as email
attachments
SSD
 Standardised description &
transmission of the data
Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
DATA COLLECTION: CONTAMINANT OCCURRENCE
~ 1Million analytical records of contaminants submitted annually from Member States
> 300 substances in EFSA contaminant occurrence database
Process contaminants
8375
6404
6029
5731
5215
3395
3035
2066
1989
1854
1842
1424
585
496
471
456
398
383
380
356
206
166
96
67
54
44
13
(2013 data collection)
Austria
Belgium
Germany
Ireland
Slovakia
Hungary
Poland
Denmark
Cyprus
France
Finland
Sweden
Slovenia
Czech Republic
Norway
Italy
Greece
United Kingdom
Latvia
Spain
Romania
Luxembourg
Lithuania
Portugal
Estonia
Bulgaria
Malta
Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
EUROPEAN DATA COLLECTIONS
 Food consumption
 Contaminant occurrence in food and feed
 Pesticide residue occurrence*
 Food additive usage & occurrence*
 Zoonoses, antimicrobial resistance & food-borne
outbreaks*
 Veterinary Drug Residues
 Molecular Typing
* Domain specific legal
obligation to collect data
Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
DATA COLLECTION NETWORKS
Network on zoonoses
monitoring data
•
Network on chemical occurrence
data
•
Network on food consumption
data collection
•
Network on pesticide residue
monitoring
•
National co-ordinators
of data reporting +
observers
Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
EXAMPLE: DIETARY EXPOSURE TO INORGANIC ARSENIC
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Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
INTRODUCTION
Arsenic in food




Arsenic is a ubiquitous metalloid.
Food and drinking water are the main routes of
exposure to arsenic.
Arsenic enters the food chain mainly through
contaminated water and soil.
Organic species (arsenobetaine, arsenosugars) are
mainly in seafood. In terrestrial foods the
predominant forms are Inorganic arsenic (iAs) and
single methylated species.
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Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
INTRODUCTION
Arsenic in food

iAs is the most toxic form
“carcinogenic to humans”].

Dimethylarsinate and methylarsonate (Group 2B)
and organic compounds (group 3)

Previous work from EFSA:

[IARC,
group
1
Scientific Opinion on arsenic in food (CONTAM Panel,
2009)
 Little or no MOE: risk cannot be excluded for some
consumers.
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Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
SCIENTIFIC REPORT 2014
Update of existing occurrence data and estimation
of dietary exposure to inorganic arsenic
Why?

New occurrence data available, including data on iAs.

Use of FoodEx (more detailed codification to classify
foods).

Use of EFSA Comprehensive
Consumption database.
European
Food
Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
SCIENTIFIC REPORT 2014
Dietary exposure

Dietary exposure calculated by combining mean iAs occurrence
value for foods collected in 21 countries (pooled European
occurrence data) with average daily consumption for each
food at individual level in each dietary survey.

EFSA Comprehensive European Food Consumption database was
used to estimate chronic dietary exposure to iAs. A total of 28
dietary surveys from 17 European countries were used (53
728 individuals).

Different methodologies used between surveys to collect the
data.
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Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
SCIENTIFIC REPORT 2014
Dietary exposure

The mean dietary exposure to iAs among the adult
population (including adults, elderly and very elderly)
ranged from 0.09-0.38 µg/kg b.w. per day (min LBmax UB) for the mean dietary exposure, and from 0.140.64 µg/kg b.w. per day (min LB- max UB) for the 95th
dietary exposure
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Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
SCIENTIFIC REPORT 2014
Dietary exposure

The mean dietary exposure to iAs among infants,
toddlers and other children ranged from 0.20-1.37
µg/kg b.w. per day (min LB-max UB) for the mean
dietary exposure, and from 0.36-2.09 µg/kg b.w. per
day (min LB-max UB) for the 95th dietary exposure.
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Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
SCIENTIFIC REPORT 2014
Estimated dietary exposure to
iAs (μg/kg b.w. per day) for
infants (six months, 6.1 kg b.w.)
consuming rice-based infant
food.
Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
SCIENTIFIC REPORT 2014
Dietary exposure
20
18
16
Milk and dairy products
Contributors
% contribution to exposure
14
Grain-based processed
products (non rice-based)
12
10
Drinking water
8
Rice
6
Vegetable and vegetable
products
4
2
0
Adolescents
Adults
Elderly
Very elderly
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Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
SCIENTIFIC REPORT 2014
Conclusions

Dietary exposure estimates are considerably lower
than those reported in the 2009 EFSA opinion.

Highest dietary exposure estimated in the younger
population (infants and toddlers) [2-4 times higher
than in the adult population].

Dietary exposure to iAs was similar among dietary
surveys. Main differences observed between LB and
UB estimations due to left-censored data.
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Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
SCIENTIFIC REPORT 2014
Conclusions

Main contributors to dietary exposure to iAs: grainbased processed products (non rice-based), rice,
milk and dairy products and drinking water.

Consumption of rice-based infant food may imply the
exposure to high levels of inorganic arsenic.

More speciation data are still needed to reduce
uncertainty
associated
to
dietary
exposure
estimates.
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Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
SCIENTIFIC REPORT 2014
Occurrence data

A total of 103 773 samples from 21 European countries
were used to calculate the dietary exposure to iAs; 2 753
samples with data on iAs were available.

Data on iAs mainly corresponded to rice (706), fish and
other seafood (1 012) and vegetables (451).

A 92.5% of the data reported as tAs were converted to iAs
using different approaches before calculating dietary
exposure to iAs.
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Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
SCIENTIFIC REPORT 2014
Occurrence data
80000
70000
– Sampling country -
Number of samples
60000
50000
40000
30000
20000
10000
0
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Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
SCIENTIFIC REPORT 2014
Occurrence data

Highest levels of iAs found in dietary supplements, seaweeds,
rice and rice products.

For rice, maximum mean values of iAs were reported for red
rice (MB= 162.4 µg/kg) and brown rice (MB= 151.9 µg/kg).

For animal and vegetable fats and oils, no data on iAs were
reported. For tAs, mean occurrence values are well below 0.1
mg/kg.

Fish and seafood reported high levels of tAs but relatively low
levels of iAs.
Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
SCIENTIFIC REPORT 2014
Occurrence data - Rice Rice, wild (8 samples)
Rice, white (189 samples)
Rice, red (12 samples)
Rice, parboiled (70 samples)
Rice, mixed (2 samples)
Rice, long-grain (130 samples)
Rice, brown (94 samples)
Rice (201 samples)
0
50
100
Mean iAs (µg /kg) at middle bound
150
200
Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
SCIENTIFIC REPORT 2014
Occurrence data - Rice –
Mean reported iAs (μg/kg)
Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
SCIENTIFIC REPORT 2014
Occurrence data - Rice products Mean iAs (µg/kg) at middle bound
140
120
100
80
60
40
20
0
Rice milling
products
Rice bread
Rice
porridge
Rice, popped
Rice flakes
Ready to eat
meal fror
children
(with rice)
Cereal based
food for
infants and
young
children
(with rice)
Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
OCCURRENCE DATA

What is important in the occurrence data
on arsenic?
-
Speciation data
Random sampling
Representative data across Europe
Country of origin/sampling country
Data on food for infants
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Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
SCIENTIFIC REPORT 2014
Occurrence data
Appropiate
description of the
reported data !!
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Importance of the use of appropriate data for dietary exposure estimations: Inorganic
arsenic as an example
http://www.efsa.europa.eu/en/panels/datex.htm
[email protected]
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