Assessment of Exposure to Food Chemicals Catherine Leclercq INRAN National Research Institute on Food and Nutrition September 28 th , 2003 INRAN – Rome, Italy Catherine Leclercq Methodological Aspects for the Collection and use of Data on Food Intake and Chemical Concentration
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Assessment of Exposure to Food Chemicals Catherine Leclercq INRAN National Research Institute on Food and Nutrition Catherine Leclercq INRAN National Research.
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Assessment of Exposure to Food Chemicals
Assessment of Exposure to Food Chemicals
Catherine LeclercqINRAN
National Research Institute on Food and Nutrition
Catherine LeclercqINRAN
National Research Institute on Food and Nutrition
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
Methodological Aspects for the Collection and use of Data on Food
Intake and Chemical Concentration
Methodological Aspects for the Collection and use of Data on Food
Intake and Chemical Concentration
RISK ANALYSISRISK ANALYSIS
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
- Risk assessmentexposure assessment
- Risk management
- Risk communication
- Risk assessmentexposure assessment
- Risk management
- Risk communication
Exposure Assessment is becoming
increasingly important
Exposure Assessment is becoming
increasingly important
Consumers demand information on exposure
Exposure assessment is needed to prioritise risk assessment
Consumers demand information on exposure
Exposure assessment is needed to prioritise risk assessment
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
AllarmsAllarms
Consumer
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
Food ContactFood Contact Material Material
Heavy metalsHeavy metalsToxic substancesToxic substances
PreservatiPreservativesves
leadlead
cadmiumcadmium
mercurymercury
dioxinedioxine
acrilamideacrilamidemycotoxins
mycotoxins
Delta-decatactone
Delta-decatactone
Allyl caproate
Allyl caproate
EucalyptolEucalyptol
Isoaly
l aceta
teIs
oaly
l aceta
te
Furfuryl alcohol
Furfuryl alcohol
FlavouringsFlavourings
Natural Natural toxicantstoxicants
cyanogenic glycosides
cyanogenic glycosides
solaninesolanine
lectinslectins
canthaxanthcanthaxanthin in
tartrazin
e
tartrazin
e
xanthophyllxanthophylls s
ColourColours s
nitritenitrite
nitrate
nitratesodium sodium
sulfite sulfite
SweeteniSweetening agentsng agents
sucralos
sucralose e
aspartam
aspartam
ee
alitamealitame
acesulfame
acesulfame
KK
saccharisaccharinn antimony
antimony trioxidetrioxide
polyethylepolyethylenene
silver zeolite Asilver zeolite A
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
Exposure assessment should allow to answer the question:
The level of intake of a specific substance is such as to constitute a
health risk for consumer?
Chemical hazards may thus be ranked not only according to their toxicity but according to the level
of risk deriving from their presence in the diet
Exposure assessment should allow to answer the question:
The level of intake of a specific substance is such as to constitute a
health risk for consumer?
Chemical hazards may thus be ranked not only according to their toxicity but according to the level
of risk deriving from their presence in the diet
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
Exposure analysis is aimed at assessing chronic and acute exposure to various substances present in the diet that may constitute a health hazard for the consumers and at comparing it with their respective safety limits.
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
These safety limits are used for contaminants and withdrawn pesticides persisting in the environment as contaminants (DDT)
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
ACUTE EXPOSUREACUTE EXPOSURE
Within an eating occasion or a day
Intake must be assessed as total intake within a restricted time interval (meal or day)
Within an eating occasion or a day
Intake must be assessed as total intake within a restricted time interval (meal or day)
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
Safety limits for CHRONIC TOXICITYCHRONIC TOXICITY: Acceptable Daily Intake (ADI)
Safety limits for CHRONIC TOXICITYCHRONIC TOXICITY: Acceptable Daily Intake (ADI)
““The amount of a food additive, The amount of a food additive, expressed on a mg/kg body weight expressed on a mg/kg body weight
basis,basis, that can bethat can be ingested daily over ingested daily over a lifetimea lifetime without incurring any without incurring any
appreciable health risk, and is based appreciable health risk, and is based on an evaluation of available on an evaluation of available
toxicological data”toxicological data”
Scientific Commitee for Food, 1991.Scientific Commitee for Food, 1991.
““The amount of a food additive, The amount of a food additive, expressed on a mg/kg body weight expressed on a mg/kg body weight
basis,basis, that can bethat can be ingested daily over ingested daily over a lifetimea lifetime without incurring any without incurring any
appreciable health risk, and is based appreciable health risk, and is based on an evaluation of available on an evaluation of available
toxicological data”toxicological data”
Scientific Commitee for Food, 1991.Scientific Commitee for Food, 1991.
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
This safety limit is used for additives and authorised pesticides.This safety limit is used for additives and authorised pesticides.
CHRONIC EXPOSURECHRONIC EXPOSURE
Within lifetimeWithin lifetime
Intake must be assessed as mean Intake must be assessed as mean intake within a long period of timeintake within a long period of time
Within lifetimeWithin lifetime
Intake must be assessed as mean Intake must be assessed as mean intake within a long period of timeintake within a long period of time
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
Sum (Food chemical concentration x Food consumption)
body weight
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
Dietary exposure = Dietary exposure =
The main sources of information about the presence and level of occurrence of the different chemicals in foods and beverages are:
analytical determination (in single foods or in market basket studies or duplicate diet studies)
legislation (presence and Maximum Permitted Levels)
labels of packaged products (recipes and ingredients)
concentration data provided by the producers.
The main sources of information about the presence and level of occurrence of the different chemicals in foods and beverages are:
analytical determination (in single foods or in market basket studies or duplicate diet studies)
legislation (presence and Maximum Permitted Levels)
labels of packaged products (recipes and ingredients)
concentration data provided by the producers. September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
Food consumption data are continuously retrieved at different level of detail
Food Balance Sheets (GEMS Food Regional Diets)
Household Budget Surveys
food consumption surveys aimed at assessing nutrient intake
consumer surveys at brand level
Food consumption data are continuously retrieved at different level of detail
Food Balance Sheets (GEMS Food Regional Diets)
Household Budget Surveys
food consumption surveys aimed at assessing nutrient intake
consumer surveys at brand level
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
The study of additive exposure from diet must take into special consideration non-average individuals, and in particular those who consume relatively large quantities of foods containing higher concentrations of a food additive.But, the issue of what proportion of the population would have to exceed the ADI before action is considered necessary to reduce intakes is both a scientific and a political/ethical question. From a scientific point in many cases there are statistical difficulties in measuring adequate percentiles of intake.
The study of additive exposure from diet must take into special consideration non-average individuals, and in particular those who consume relatively large quantities of foods containing higher concentrations of a food additive.But, the issue of what proportion of the population would have to exceed the ADI before action is considered necessary to reduce intakes is both a scientific and a political/ethical question. From a scientific point in many cases there are statistical difficulties in measuring adequate percentiles of intake.
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
The objective is always to determine the proportion of the population that regularly exceeds the ADI. The highest percentiles of mean daily intake are therefore usually estimated.
The objective is always to determine the proportion of the population that regularly exceeds the ADI. The highest percentiles of mean daily intake are therefore usually estimated.
Example of a food chemical intake distributionExample of a food chemical intake distribution
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
Moreover the monitoring of additives intake have to be repeated regularly because the market of food products changes very rapidly in relation to both product formulation and consumer preferences.
The monitoring activity must be carried out by collecting and analysing data concerning food consumptions and additives presence and concentration in the same food products.
Moreover the monitoring of additives intake have to be repeated regularly because the market of food products changes very rapidly in relation to both product formulation and consumer preferences.
The monitoring activity must be carried out by collecting and analysing data concerning food consumptions and additives presence and concentration in the same food products.
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
The number of chemical substances that should be monitored is huge.
For example:
The food additives authorized in the EU are more than 300.
More than 2800 different flavouring substances are claimed by industry to be added to foods and beverages in Europe.
The number of chemical substances that should be monitored is huge.
For example:
The food additives authorized in the EU are more than 300.
More than 2800 different flavouring substances are claimed by industry to be added to foods and beverages in Europe.
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
Stepwise procedure: target detailed dietary exposure estimates to chemicals which might be of health concern for the general population or for certain at-risk groups.
Exposure is first assessed by using methods based on conservative assumptions.
If the estimated exposure to a given chemical substance exceeds its safety limit (ADI, TDI, etc.) a more accurate method of dietary exposure assessment should be applied.
Stepwise procedure: target detailed dietary exposure estimates to chemicals which might be of health concern for the general population or for certain at-risk groups.
Exposure is first assessed by using methods based on conservative assumptions.
If the estimated exposure to a given chemical substance exceeds its safety limit (ADI, TDI, etc.) a more accurate method of dietary exposure assessment should be applied. September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
As the accuracy of dietary exposure assessments increases, the cost of collecting adequate data and the resources needed to undertake the assessments also increase.
As the accuracy of dietary exposure assessments increases, the cost of collecting adequate data and the resources needed to undertake the assessments also increase.
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
An example of the stepwise approach in
the case of
ANTIOXIDANTS
(food additives)
An example of the stepwise approach in
the case of
ANTIOXIDANTS
(food additives)
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
AntioxidantsFood products in which the use is permitted
mg/kgAnimal fats and oils; Fats and oils for the professional manufacture of heat-treated foodstuffs Cake mixes, cereal-based snack foods, milk powder for vending machines, dehydrated soups and broths, sauces, dehydrated meat, processed nuts,seasonings and condiments, pre-cooked cereals
200 mg/kg
Dehydrated granulated potatoes 25
mg/kg
Erythorbic acid and its salts(E315-E316)
Semi-preserved and preserved meat products
500 mg/kgSemi-preserved and preserved fish
productsFrozen and deep-frozen fish with red skin
1500 mg/kg
Butylated Hydroxytoluene(BHT) (E321)
Animal fats and oils Fats and oils for the professional manufacture of heat-treated foodstuffs
100mg/kg
Chewing gum, dietary supplements 400
mg/kg
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
Step 1 - Budget Method: It is based on the existence of a physiological upper limit to the amount of food and drink that can be ingested each day: maximum energy intake: 50 kcal / kg bw / day maximum liquid intake: 100 ml/kg bw / dayIn a 60 kg subject: 1.5 kg of food and 6 l of beverages per day.
Further assumptions: The additive is always used at its highest MPL in foods and in beverages (considering only significant uses) The proportion of the diet that may contain the additive can be roughly estimated.
Method used by CODEX FAC and within SCCOP projects (European Commission).
Step 1 - Budget Method: It is based on the existence of a physiological upper limit to the amount of food and drink that can be ingested each day: maximum energy intake: 50 kcal / kg bw / day maximum liquid intake: 100 ml/kg bw / dayIn a 60 kg subject: 1.5 kg of food and 6 l of beverages per day.
Further assumptions: The additive is always used at its highest MPL in foods and in beverages (considering only significant uses) The proportion of the diet that may contain the additive can be roughly estimated.
Method used by CODEX FAC and within SCCOP projects (European Commission).
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
DANISH BUDGET METHOD:DANISH BUDGET METHOD: assessment of total assessment of total maximum daily intake based on maximum maximum daily intake based on maximum
physiological intakesphysiological intakesThe case of BHTThe case of BHT
TMDI = TMDI = (1.5 x 0.125 x 100 + 6 x 0) / 60(1.5 x 0.125 x 100 + 6 x 0) / 60 = =
0.312 =0.312 = 6.3 x ADI 6.3 x ADI
1/81/80%0%
(6 l)(6 l)(1.5 kg)(1.5 kg)
100 100 mg/kgmg/kg
Solid foodsSolid foods Liquid foodsLiquid foods
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
Step 2: method for which only aggregated data are required (i.e. Household Budget Survey data).
Step 2: method for which only aggregated data are required (i.e. Household Budget Survey data).
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
For each food category: Average Theoretical Intake (ATI) = Average consumption X MPL
For each food category: Average Theoretical Intake (ATI) = Average consumption X MPL
Extreme Theoretical Intake (ETI) = High consumption (95th percentile) X MPL Extreme Theoretical Intake (ETI) = High consumption (95th percentile) X MPL
Overall Theoretical Extreme Intake: sum of the two highest ETI + sum of the ATI of all the other categories.(intake in a high consumer of two food categories who is an average consumer of all the others)
Method developed within SCOOP Task 4.2 (European Commission)
Overall Theoretical Extreme Intake: sum of the two highest ETI + sum of the ATI of all the other categories.(intake in a high consumer of two food categories who is an average consumer of all the others)
Method developed within SCOOP Task 4.2 (European Commission)
Step 3: method for which consumption data at individual level are required (i.e. ad hoc food consumption surveys ).
Subjects recorded all foods and beverages ingested during 14 consecutive days. The weight of each single food recorded was transformed into the weight of single raw foods as described into the Italian national food composition tables.
The additive was always used at its MPL authorized in the corresponding food or beverage.
Step 3: method for which consumption data at individual level are required (i.e. ad hoc food consumption surveys ).
Subjects recorded all foods and beverages ingested during 14 consecutive days. The weight of each single food recorded was transformed into the weight of single raw foods as described into the Italian national food composition tables.
The additive was always used at its MPL authorized in the corresponding food or beverage.
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
Potential dietary intake of antioxidants.
Potential dietary intake of antioxidants.
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
Exposure models referred to other categories of chemicals:Exposure models referred to other categories of chemicals:
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
Veterinary drugs residues
MRL are such that 300 g X MRL in meat + 100 g X MRL in liver + 50 g X MRL in kidney + 50 g X MRL in animal fats + 100 g X MRL in eggs + 1,5 litres X MRL in milk < ADI
(99th percentile of eaters)
Veterinary drugs residues
MRL are such that 300 g X MRL in meat + 100 g X MRL in liver + 50 g X MRL in kidney + 50 g X MRL in animal fats + 100 g X MRL in eggs + 1,5 litres X MRL in milk < ADI
(99th percentile of eaters)
Migrants from Food Contact Materials
migration is such that intake of 1 kg of food in contact with 600 cm2 of the relevant food contact material < TDI
Migrants from Food Contact Materials
migration is such that intake of 1 kg of food in contact with 600 cm2 of the relevant food contact material < TDI
The International Estimate of Short Term Intake (IESTI): conservative method for the assessment of short-term dietary exposure to pesticide residues.
For each commodity separately: Weight a large portion (97.5th percentile of eaters on a single day) X highest residue level of contamination.(based on available data for food consumption and residue levels)
This method may not be used to assess overall theoretical intake: it can not be assumed that on a given day a consumer may consume large portions of all commodities all of them maximally contaminated.Proposed by FAO/WHO (2001)
The International Estimate of Short Term Intake (IESTI): conservative method for the assessment of short-term dietary exposure to pesticide residues.
For each commodity separately: Weight a large portion (97.5th percentile of eaters on a single day) X highest residue level of contamination.(based on available data for food consumption and residue levels)
This method may not be used to assess overall theoretical intake: it can not be assumed that on a given day a consumer may consume large portions of all commodities all of them maximally contaminated.Proposed by FAO/WHO (2001)
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
The Theoretical Added Maximum Daily Intake (TAMDI) is a conservative method used to assess exposure to flavouring substances.
Assumptions:- daily intake of 160.4 g/day of flavourable foods and 324 ml/day of flavourable drinks* - flavouring substance always present in foods and drinks at the “upper use level” specified by the Council of Europe.
* twice the quantity taken as likely to contain intense sweeteners according to CODEX.September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
assume 100% presence if legally permissible
assume presence always at legal maximum permitted level (MPL and MRL)
Conservative deterministic approach
Conservative deterministic approach
For all eating occasions of target foods:
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
Within the Montecarlo project,
refined databases have been
created for the purpose of
estimating as accurately as
possible ‘true’ chemical intakes in
order to assess the validity of
probabilistic models.
Within the Montecarlo project,
refined databases have been
created for the purpose of
estimating as accurately as
possible ‘true’ chemical intakes in
order to assess the validity of
probabilistic models.
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
Project coordinator: Institute of European Food Studies (Ireland)
Participants: School of Mathematics, TCD (Ireland)
TNO (The Netherlands) Institute of Human Nutrition, IOHN (UK)
food additives, based on brand level food consumption and ingredient composition.
pesticide residues, based on duplicate diets.
nutrients, based on biomarker studies.
Databases of “true” intakes of
food additives, based on brand level food consumption and ingredient composition.
pesticide residues, based on duplicate diets.
nutrients, based on biomarker studies.
Acquisition of data for validation studies
Acquisition of data for validation studies
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
Partners: RIKILT (The Netherlands) and Gobierno Vasco (Spain)Substances: Five pesticides (chlorpyrifos, iprodione, pirimicarb, pirimiphos-methyl, chlorfenvinphos)
Databanks available for stochastic modelling: Standard food consumption surveys, recipes database Pesticide residue database for Raw Agricultural Commodities Conversion factors of edible portions of food items into RAC
Additional information needed: pesticide content of individual diets processing factors for all pesticide-commodity combinations variability factors for all pesticide-commodity combinations
Method used for data collection: collection of duplicate diet and food diaries in 250 infants literature data on processing factors and variability factors
Hypothesis tested: a valid distribution of pesticides intake can be obtained from standard consumption surveys and pesticide residue databases if processing and variability factors are known.
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
Databanks available for stochastic modelling: Standard food consumption survey codified at food category level Household purchases at brand level
Additional information needed: individual food consumption at brand level additive presence and concentration at brand level additive intakes in high consumers
Method used for data collection: repeated registration of consumption of sugar-free products at brand level in both random and pre-screened high consumers (teenagers) creation of an ingredient database of sugar-free products with presence and concentration of intense sweetenersHypothesis tested: a valid distribution of additives intake can be obtained from
standard consumption survey, ingredient database and information on brand loyalty and market share; the model provides a valid estimate of intakes in high consumers.
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
Data typically needed to estimate food additive intake
Data typically needed to estimate food additive intake
• Mean population intake 30 g/d• Percentage of consumers 50%• Mean consumers intake 60 g/d• 97.5th %ile consumers intake 180
g/d
Key needs: Individual data with sufficient number
of subjects Accuracy of percentage consumers
(sufficient survey duration) control of under-reporting
• Mean population intake 30 g/d• Percentage of consumers 50%• Mean consumers intake 60 g/d• 97.5th %ile consumers intake 180
g/d
Key needs: Individual data with sufficient number
of subjects Accuracy of percentage consumers
(sufficient survey duration) control of under-reporting
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
FAO/WHO expert Committees on food chemical
JECFA: Joint FAO/WHO Expert Committee on Food Additives
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
Panel on Panel on plant health, plant health, plant plant protection protection products products and their and their residuesresidues
Panel on Panel on food food additives, additives, flavourings, flavourings, processing processing aids and aids and materials in materials in contact with contact with foodfood
Panel on Panel on geneticallgenetically y modified modified organismorganismss
Panel on Panel on additives additives and and products or products or substances substances used in used in animal feedanimal feed
Panel on Panel on dietetic dietetic products, products, nutrition nutrition and and allergiesallergies
Panel on Panel on biological biological hazards hazards (including (including TSE/BSE TSE/BSE issues)issues)
Panel on Panel on contaminacontaminants in the nts in the food chainfood chain
Panel on Panel on animal animal health health and and welfarewelfare
September 28th, 2003 INRAN – Rome, Italy Catherine Leclercq
European Food Safety AuthorityEuropean Food Safety AuthoritySCIENTIFIC COMMITTEESCIENTIFIC COMMITTEE