4 heppner nitrate vegetables (2)

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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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    5

    On the one hand.......

    Vegetables are part of a healthy diet

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    EFET Greek Focal Point of EFSA: Scientific challenges and directions for policy making in nutrition , Athens, 22.10.2010

    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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    EFET Greek Focal Point of EFSA: Scientific challenges and directions for policy making in nutrition , Athens, 22.10.2010 18

    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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    EFET Greek Focal Point of EFSA: Scientific challenges and directions for policy making in nutrition , Athens, 22.10.201023

    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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    EFET Greek Focal Point of EFSA: Scientific challenges and directions for policy making in nutrition , Athens, 22.10.201024

    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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    EFET Greek Focal Point of EFSA: Scientific challenges and directions for policy making in nutrition , Athens, 22.10.2010

    27

    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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    EFET Greek Focal Point of EFSA: Scientific challenges and directions for policy making in nutrition , Athens, 22.10.2010

    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.htm
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    EFET Greek Focal Point of EFSA: Scientific challenges and directions for policy making in nutrition , Athens, 22.10.2010

    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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    !