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Nitrate in vegetables balancingrisks and benefits
Scientific opinion of the CONTAM Panel adopted 2008
Claudia Heppner Unit on Contaminants
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EFET Greek Focal Point of EFSA: Scientific challenges and directions for policy making in nutrition , Athens, 22.10.2010
Overview
Introduction
Occurrence and exposure
Hazard identification and characterisation
Risk characterisation
Benefit identification and characterisation
Risk benefit characterisation
Conclusions
Recommendations
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In t roduct ion
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EFET Greek Focal Point of EFSA: Scientific challenges and directions for policy making in nutrition , Athens, 22.10.2010
Consumers need clear advice
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On the one hand.......
Vegetables are part of a healthy diet
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On the other hand......
Gastric Carcinoma Blue Baby Syndrome
Nitrate via nitrite can lead to potential adversehealth outcomes
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EFET Greek Focal Point of EFSA: Scientific challenges and directions for policy making in nutrition , Athens, 22.10.2010 7
..provide a scientific risk assessment for thelonger term strategy for managing the r iskfrom nitrate in vegetables.
..to assess the r isks to consumers from ni t rate
in vegetables. The assessment shou ld takeinto accoun t the amounts o f ni t rate found in
vegetables as consumed and any relevant
cons iderat ions on the possib le balance
between risks and beneficial health effects.
EFSA was asked by EC
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EFET Greek Focal Point of EFSA: Scientific challenges and directions for policy making in nutrition , Athens, 22.10.2010
EU legislation: Regulation (EC)No 1881/2006
Foodstuff Maximum levels (mg nitrate/kg)
Fresh spinach Harvested 1 October to 31 March
Harvested 1 April to 30 September3000
2500
Preserved, deep-frozen or frozen
spinach
2000
Fresh lettuce (protected and open-
grown lettuce) excl lettuce l below
Harvested 1 October to 31 March:
lettuce grown under cover
lettuce grown in the open air
Harvested 1 April to 30 September
lettuce grown under cover
lettuce grown in the open air
4500
4000
3500
2500
Iceberg-type lettuce Lettuce grown under cover
Lettuce grown in the open air
2500
2000
Processed cereal-based foods and
baby foods for infants & young200
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The four-step paradigm in risk assessment
Occurrence data
EFSA: E.U. MemberStates, Island, Norway,
Switzerland andLiechtenstein
Food consumptiondata
Concise European FoodConsumption Database
Exposure assessment
Deterministic vs. probabilistic approach
Adults, subgroups of population (e.g. children, infants,
vegetarians, pregnant women etc
Risk characterisationRelating exposure estimates to health based guidance value
Hazard identification
Hazard characterisation
ADME, acute, subchronic & chronic toxicity
human studies genotox, reprotox,immunotox,
mode/mechanism of action, dose-response,
selection of critical dataset and e.g. NOEAL,
mathematical modelling (BMD) including the
establishment of a health based guidance value
(e.g. ARfD, TDI)
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Occurrence/exposure
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EFET Greek Focal Point of EFSA: Scientific challenges and directions for policy making in nutrition , Athens, 22.10.2010 11
52%
8%
6%
12%
22%
75%
6%
4%
1%
14%
91 mg/person/day 141 mg/person/day
Dietary nitrate
exposure - UK
Dietary nitrate
exposure - France
Vegetables and fruit Animal-based products Other foods Beer Water Conversion of nitrate
Nitrate in our diets
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EFET Greek Focal Point of EFSA: Scientific challenges and directions for policy making in nutrition , Athens, 22.10.2010 12
11%
35%47%
0%7%
41%
39%
15%
0% 5%
1.5 mg/person/day 2.0 mg/person/day
Dietary nitrite
exposure - UK
Dietary nitrite
exposure - France
Nitrite in our diets
External sources
Vegetables and fruit Animal-based products Other foods Beer Water Conversion of nitrate
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EFET Greek Focal Point of EFSA: Scientific challenges and directions for policy making in nutrition , Athens, 22.10.2010 13
2% 6%
8%0%
1%
83%
7.3 mg/person/day
6%
85%
2%6%
0%
1%
11.3 mg/person/day
Total nitrite exposure
- UK
Total nitrite exposure
- France
Total Nitrite in our diets
External + Internal
Vegetables and fruit Animal-based products Other foods Beer Water Conversion of nitrate
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EFET Greek Focal Point of EFSA: Scientific challenges and directions for policy making in nutrition , Athens, 22.10.2010 14
So how did the CONTAM Panel tackle the
assessment of nitrate in vegetables?
Analytical data from 20 Member
States and Norway from 2000-2007 41,415
Vegetable varieties (sufficient data) 59
Vegetable Categories as in 9(EC 178/2006)
Huge range median nitrate conc. 1 4,800mg/kg
Data below LOD
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EFET Greek Focal Point of EFSA: Scientific challenges and directions for policy making in nutrition , Athens, 22.10.2010 15
Nitrate levels in vegetable groups
Brassic
aveg
etable
s
Bulb
vegetab
les
Fruit
ingvegetab
lesFu
ngi
Herb
s
Leafy
vegetab
les
Legume
s
Stem
vegetab
les
Rootsand
Tube
rs
0
1000
2000
3000
4000
5000
Medianconce
ntrationmg/kg
24160 41
791
1,140
56
302
15283
Rucola
Butterhead lettuce
Lettuce
Iceberg lettuce
Spinach
Water cress
4,800
1,978
915
785
12
844
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Influence of season, production
system and region on nitrate levels
0
100
200
300
400
500
600
700
800
900
1000
covered
field
covered
field
covered
field
covered
field
covered
field
covered
field
summer winter summer winter summer winter
North Central South
Lettuce varieties
Nu
mberofsamples
0
500
1000
1500
2000
2500
3000
3500
4000
4500
5000
Nitrate
concentrationmg/kg
Nitrate levels in lettuce produced in southern < northern Europe
Production under cover lead to higher nitrate levels
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Mitigation factors for nitrate
Storage time and conditions (ambient,refrigerated, frozen) and food processing
(washing, peeling, blanching, boiling) can
influence nitrate levels.
E.g. reduction of nitrate levels by 10-15% when
washing leafy vegetables, 30% when peeling
potatoes, 16 to 79% when cooking peas,
beans, carrots, potatoes, spinach, endives andcelery leaves.
Paucity of published data in this area
EFET Greek Focal Point of EFSA: Scientific challenges and directions for policy making in nutrition , Athens, 22.10.2010
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Vegetable Consumption is very
variable in Europe
No typical consumer
Estimates of WHO GEMS Food Consumption cluster dietsdatabase: mean 372 g
Data from 11 Member States & Norway: 97.5th percentile 393 g
WHO recommendation: 400g/person/day fruit and vegetables
CONTAM selected 400 g/person/day as a conservative figure
Tested impact of different high consumer scenarios, eg.,
771g potatoes/d Ireland and 133g/d leafy vegetables in Spain
ASSUMED ALL CONSUMED AS VEGETABLES
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Exposure scenarios
Scenarios Vegetableconsumption
(g/person/day)
EU overall mediannitrate conc.
(mg/kg)
Exposure(mg NO3/person/
day)
S1 400 (mix, except
potatoes)
392 157
S2 771 (potatoes) 106 82
S3 133 (spinach/ lettuce/
1/3 rucola 2/3 lettuce)
785/1,338/4,800 104/178/330
S4 133 (spinach/lettuce)/
267 (mix)
785/1,338/392 209/283
S5 133(spinach/lettuce)/
267 (mix)
1,745/2,652/392
Highest regional median
nitrate conc.
337/457
-
Main driver not amount of vegetable eaten, but type and nitrate content
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Children
No accurate data on vegetable consumption, hence 200 g
was chosen as a realistic estimate. For a 20 kg child
nitrate exposure would be between 2 and 12 mg/kg b.w.
per day.
The CONTAM Panel is current ly addressin g poss ible pub l ic
heal th r isks for in fants and young chi ldren from the presence of
n i t rates in leafy vegetables - due to 15 Dec 2010
Vegetarians
Protein requirements from animal products are
substituted by cereals, nuts, pulses (low nitrate content)
and not by excessive amounts of vegetables. Vegetarians
are not different from S1 scenario (400 g vegetables).
Population subgroups
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Hazard ident i f icat ion andcharacter isat ion
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EFET Greek Focal Point of EFSA: Scientific challenges and directions for policy making in nutrition , Athens, 22.10.2010 22
Nitrate is quickly absorbed from the gastrointestinal tractinto the plasma.
App. 25% of the plasma nitrate is via the salivary glands
bioconcentrated app. 10-fold and secreted into the saliva.
App. 20% of the secreted nitrate is reduced to nitrite.
Under acidic conditions, nitrate is transformed to NO and
other metabolites.
Most adsorbed nitrate is excreted in the urine.
Salvage through reabsorption from the kidney together
with biliary and salivary recirculation.
Toxicokinetics
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Toxicity of nitrate is low and adverse effects canoccur from its metabolic conversion to nitrite.
Since the last evaluation by JECFA in 2003 no new
significant toxicity data have been reported.
Nitrate/nitrite is not genotoxic;
Nitrate has a low chronic toxicity;
Nitrate is not carcinogenic to humans (JECFA, 2003).
General toxicity
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Former SCF and JECFA derived an ADI of
3.7 mg/kg b.w. / day (60 kg adult)
The ADI equates to 222 mg/day for an
adult.
No new data were identified by the
CONTAM Panel to revise this ADI.
Acceptable daily intake (ADI) - nitrate
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Risk charac ter isat ion
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Exposure scenarios vs. ADI
Scenarios Vegetableconsumption
(g/person/day)
Exposure(mg NO3/person/
day *)
% of ADI(mg/day for 60 kg
adult)
S1 400 (mix, except
potatoes)
201 91
S2 771 (potatoes) 126 57S3 (A/B/C) 133 (spinach/ lettuce/
1/3 rucola 2/3 lettuce)
148/222/374 67/100/168
S4 133 (spinach/lettuce)/
267 (mix)
253/327 114/147
S5 133(spinach/lettuce)/
267 (mix) regional
381/501 172/226
-
*) inc. background exposure from other sourc es 44 mg /person/day
Exposure normally below the ADI, but can be
exceeded for certain consumers
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S3C: Consumption of 1/3 of leafy vegetables asrucola.
47 g rucola would result in an excursion above the
ADI without taking background into consideration.
S4 and S5: High-level consumer of vegetables and
lettuce at 97.5th percentile or at the highest regional
level.
Occasional exceedance of the ADI by two-fold will
not lead to appreciable heath risks.
Exceedance of ADI
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Benef i t iden t i ficat ion andcharacter isat ion
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EFET Greek Focal Point of EFSA: Scientific challenges and directions for policy making in nutrition , Athens, 22.10.201029
Whole vegetables v phytochemicals
Putting two and two
together, scientists
assumed that these
antioxidants wereprotective and that
taking them.. in
fortified foods
should decrease
oxidative damage
The Good the Fad and the
Unhealthy
Wh t th I t f ti
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EFET Greek Focal Point of EFSA: Scientific challenges and directions for policy making in nutrition , Athens, 22.10.201030
What are the Impacts of eating
vegetables?
Vegetables are good for your health400g fruit and vegetables/day
recommended by WHO, 2003
Prevention of non-communicable diseases eg
cardiovascular
cancer
obesity
type 2 diabetes
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Risk /benef i t charac ter isat ion
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EFET Greek Focal Point of EFSA: Scientific challenges and directions for policy making in nutrition , Athens, 22.10.2010
Balancing risk and benefit
Pros and cons of exposure to nitratePros and cons of eating vegetables
NO3 Vegetable
risk riskbenefit benefit
metHb
cancer
host defence
nitric oxide
antinutrients
allergensmycotoxins
contaminants
pesticide residues
health
macro/micro nutrientslifestyle
W i hi i k d b fi
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EFET Greek Focal Point of EFSA: Scientific challenges and directions for policy making in nutrition , Athens, 22.10.2010
Weighing risks and benefits
Benefits
Risks
Net health impact
QA-LIBRA
Quality of life balance
Benefits
Risks
Net health impact
QA-LIBRA
Quality of life balance
Net Health
Benefit
Vegetables
c.400g/day
Nitrate @
or below
ADI
vegetables
high
low
Overall the estimated exposures to nitrate from vegetables are unlikely
to result in appreciable health effects.
The beneficial effects of eating vegetables prevail.
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Conc lus ions &recommendat ions
C l i
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Conclusions
No need to revise the ADI for nitrate.
Minority of Europeans eat 400g vegetables/day.
Nitrate reduces during processing & cooking & is low in
fruit.
Thus for the majority, vegetable nitrate intake is below the
ADI.
High level consumers may exceed the ADI two fold.
Consumption of 47 g rucola leads to an excursion of the
ADI.
C l i
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Conclusions
General consensus that a balanced diet high in vegetables
and fruit confers significant health benefits (reduction of
non-communicable diseases).
Overall, estimated exposures to nitrate from vegetables
are unlikely to result in appreciable health risks. The
recognised beneficial effects of consumption of
vegetables prevail. Occasionally circumstances (eg.
unfavourable production conditions, diets with high
rucola) which need to be assessed on a case by case
basis.
R d ti
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Recommondation
Need for research into factors influencing nitratelevels during production, storage and processing.
Member States should submit individual analytical
results on those crops regularly found to contain
high nitrate levels.
Monitoring of dietary habits of vegetables e.g. rucola
Continue efforts to progress in methodology for risk-
benefit analysis of foods.
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For fur ther informat ion
The opinion of the CONTAM Panel related to
nitrate in vegetables (question No. EFSA-Q-
2006-071) is available at URL:
http://www.efsa.europa.eu/en/scdocs/scdoc/689.htm
http://www.efsa.europa.eu/en/scdocs/scdoc/689.htmhttp://www.efsa.europa.eu/en/scdocs/scdoc/689.htm8/13/2019 4 Heppner Nitrate Vegetables (2)
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ACKNOWLEDGEMENT
Working group members
Tom Addiscott Piet van den Brandt
Andrew Cockburn (chair)
Maria-Luisa Fernandez-Cruz
Per Ola Danerud
Peter Fuerst
Gerrit Speijers
Philippe Verger
Hans Verhagen
CONTAM Panel members
2006-2009
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!