22
Risk Assessment in Chemical Food Safety Dept. of Food Safety and Zoonoses (FOS) http://www.who.int/foodsafety/en/
Risk Assessment in
Chemical Food Safety
Dept of Food Safety and Zoonoses (FOS) httpwwwwhointfoodsafetyen
2 |
Risk Analysis Paradigm
Scientific data
analysis
Regulation and control
Dialog with all stakeholders
Risk Communication
Internationally
Risk Management
Codex amp Member States
Risk Assessment
WHO amp FAO
Risk Assessment A Scientific Process
Hazard Identification
Hazard Characterization
Exposure Assessment
Risk Characterization
Problem Formulation RM
RA
Risk =
Hazard x Exposure
4 |
Example of chemical risk assessment
5 |
Main Question in Food Safety
What is a bdquosaferdquo human exposure over lifetime
eg a dose with rdquono appreciable or a negligible riskrdquo
BUT for some scenarioscompounds also acute risks relevant
6 |
General considerations re RA
Identify problems - prioritization
Define the scope
Relevant expertise ndash chemists toxicologists epidemiologists modellersstatisticians
veterinarians etc
Interaction between risk assessor and risk manager ndash common understanding of problem
Recognise limitations in data resources - be transparent
Take the whole database into account - integrate results
WHO
Hazard
Assessment
Exposure
Assessment
Key NOAEL
Uncertainty
factors
Safety standard
(Health based guidance value)
eg ADI=NOAELUfs
Chemical
analysis
Food
consumption
X
Exposure
Safety assurance
Exposure lt ADI
Exposure gt ADI Management
Decision
8 |
A process to determine
possible adverse
effects of a chemical on
the organism1
- hazard identification
- hazard characterization
Hazard Assessment
1 adapted from EHC 240 Principles and methods for the risk assessment of chemicals in food Annex 1 Glossary of terms FAOWHO 2009
httpappswhointirisbitstream106654406513WHO_EHC_240_13_eng_Annex1pdfua=1
9
Hazard Assessment
Assessment Procedure Identification of critical endpointeffect and
critical studydata set ndash most sensitive species most sensitive endpoint of
relevance to humans most relevant epidemiological study
Dose-response analysis (Point of Departure) ndash NoLow Observed Adverse Effect Level (NLOAEL)
Benchmark Dose (BMD BMDL)
Identification of uncertainties assignment of uncertaintysafety factors
Outcome Health based guidance value (ADI TDI ARfD)
quantitative risk at specific exposure qualitative descriptor other guidance to risk manager (eg MOE)
10 |
ldquohellip the qualitative
andor quantitative
evaluation of the likely
intake of biological
chemical and physical
agents via food helliprdquo1
Dietary Exposure Assessment
1 The Codex Alimentarius Commissionrsquos (CAC) Procedural Manual (FAOWHO 2008a)
11 |
Dietary Exposure Assessment
Combining food consumption data with occurrence of chemical in food
Deterministic approach (point estimate)
Probabilistic approach (distribution)
Outcome ndash Estimated mean and high dietary exposures
ndash Identification of specific sub-groups
ndash Identification of key exposure sources
Reference httpwwwwhointfoodsafetychemjecfaenintake_guidelinespdf
12 |
Types of Risk Assessment
Rapid risk assessment ndash emergencies
Qualitative RA ndash due to lack of data or lack of health concern
Quantitative RA ndash derivation of guidance value or full expression of probability of adverse health outcome at defined level of exposure
Dat
a an
d r
eso
urc
e n
eed
s
13
Hazard assessment
Biochemical data - Absorption distribution excretion metabolism effects on enzymes
Toxicological data ndash Acute short-term long-term toxicity amp carcinogenicity (mainly rats and
mice sometimes dogs) ndash Genotoxicity (in vitro and in vivo) ndash Reproductive and developmental toxicity (mainly rats) ndash Special studies (eg immunotoxicity cardiovascular effects thyroid
function)
Observations in humans
What are data
Independant of geographic origin
14
Exposure assessment
Food consumption data - Average high consumption different age groups
Occurrence data ndash Amount in food (raw processedhellip)
What are data
Country region dietary habit specific
15 |
Where do data come from
- Regulatory data submission by manufacturer
For compounds intentionally added to foods
- Data from governments
- Monitoring data epidemiological data research data
- Open scientific literature
- Experimental research human data
16 |
ADITDI
Level of health concern
Sources of exposure
Prioritization
Codex Alimentarius Commission
Toxicology amp Epidemiology
(WHO)
Chemistry Analytics (FAO)
JECFA
General procedure and interaction
FAOWHO
Secretariat to
schedule meetings
Call for data
Call for experts
Standards Recommendations
17 |
Scientific advice work feeds into
Codex standard setting process
Nationalregional risk assessments and food legislation
WHO programmes
ndash INFOSAN ndash rapid risk assessment information notes
ndash drinking water guidelines
ndash WHOPES (public health use of pesticides)
ndash Childrens environmental health
ndash Global Alert and Response
International RA method development and harmonization
Principles and Methods
EHC 240 Principles and methods for the risk assessment of chemicals in food WHO 2009
Risk assessment guidance for all food chemicals
Guidance on interpretation of studies and general assessments
Descriptive guidance not prescriptive
Electronic publication in individual chapters ndash for update
httpwwwwhointfoodsafetychemprinciplesenindex1html
WHO databases httpwwwwhointfoodsafetydatabasesen
JECFA and JMPR databases
httpappswhointfood-additives-contaminants-jecfa-databasesearchaspx
httpappswhointpesticide-residues-jmpr-database
JECFA and JMPR databases - FAO
httpwwwfaoorgfoodfood-safety-qualityscientific-advicejecfaen
httpwwwfaoorgagriculturecropsthematic-sitemapthemepestslpeen
22 |
Thank you
Question
2 |
Risk Analysis Paradigm
Scientific data
analysis
Regulation and control
Dialog with all stakeholders
Risk Communication
Internationally
Risk Management
Codex amp Member States
Risk Assessment
WHO amp FAO
Risk Assessment A Scientific Process
Hazard Identification
Hazard Characterization
Exposure Assessment
Risk Characterization
Problem Formulation RM
RA
Risk =
Hazard x Exposure
4 |
Example of chemical risk assessment
5 |
Main Question in Food Safety
What is a bdquosaferdquo human exposure over lifetime
eg a dose with rdquono appreciable or a negligible riskrdquo
BUT for some scenarioscompounds also acute risks relevant
6 |
General considerations re RA
Identify problems - prioritization
Define the scope
Relevant expertise ndash chemists toxicologists epidemiologists modellersstatisticians
veterinarians etc
Interaction between risk assessor and risk manager ndash common understanding of problem
Recognise limitations in data resources - be transparent
Take the whole database into account - integrate results
WHO
Hazard
Assessment
Exposure
Assessment
Key NOAEL
Uncertainty
factors
Safety standard
(Health based guidance value)
eg ADI=NOAELUfs
Chemical
analysis
Food
consumption
X
Exposure
Safety assurance
Exposure lt ADI
Exposure gt ADI Management
Decision
8 |
A process to determine
possible adverse
effects of a chemical on
the organism1
- hazard identification
- hazard characterization
Hazard Assessment
1 adapted from EHC 240 Principles and methods for the risk assessment of chemicals in food Annex 1 Glossary of terms FAOWHO 2009
httpappswhointirisbitstream106654406513WHO_EHC_240_13_eng_Annex1pdfua=1
9
Hazard Assessment
Assessment Procedure Identification of critical endpointeffect and
critical studydata set ndash most sensitive species most sensitive endpoint of
relevance to humans most relevant epidemiological study
Dose-response analysis (Point of Departure) ndash NoLow Observed Adverse Effect Level (NLOAEL)
Benchmark Dose (BMD BMDL)
Identification of uncertainties assignment of uncertaintysafety factors
Outcome Health based guidance value (ADI TDI ARfD)
quantitative risk at specific exposure qualitative descriptor other guidance to risk manager (eg MOE)
10 |
ldquohellip the qualitative
andor quantitative
evaluation of the likely
intake of biological
chemical and physical
agents via food helliprdquo1
Dietary Exposure Assessment
1 The Codex Alimentarius Commissionrsquos (CAC) Procedural Manual (FAOWHO 2008a)
11 |
Dietary Exposure Assessment
Combining food consumption data with occurrence of chemical in food
Deterministic approach (point estimate)
Probabilistic approach (distribution)
Outcome ndash Estimated mean and high dietary exposures
ndash Identification of specific sub-groups
ndash Identification of key exposure sources
Reference httpwwwwhointfoodsafetychemjecfaenintake_guidelinespdf
12 |
Types of Risk Assessment
Rapid risk assessment ndash emergencies
Qualitative RA ndash due to lack of data or lack of health concern
Quantitative RA ndash derivation of guidance value or full expression of probability of adverse health outcome at defined level of exposure
Dat
a an
d r
eso
urc
e n
eed
s
13
Hazard assessment
Biochemical data - Absorption distribution excretion metabolism effects on enzymes
Toxicological data ndash Acute short-term long-term toxicity amp carcinogenicity (mainly rats and
mice sometimes dogs) ndash Genotoxicity (in vitro and in vivo) ndash Reproductive and developmental toxicity (mainly rats) ndash Special studies (eg immunotoxicity cardiovascular effects thyroid
function)
Observations in humans
What are data
Independant of geographic origin
14
Exposure assessment
Food consumption data - Average high consumption different age groups
Occurrence data ndash Amount in food (raw processedhellip)
What are data
Country region dietary habit specific
15 |
Where do data come from
- Regulatory data submission by manufacturer
For compounds intentionally added to foods
- Data from governments
- Monitoring data epidemiological data research data
- Open scientific literature
- Experimental research human data
16 |
ADITDI
Level of health concern
Sources of exposure
Prioritization
Codex Alimentarius Commission
Toxicology amp Epidemiology
(WHO)
Chemistry Analytics (FAO)
JECFA
General procedure and interaction
FAOWHO
Secretariat to
schedule meetings
Call for data
Call for experts
Standards Recommendations
17 |
Scientific advice work feeds into
Codex standard setting process
Nationalregional risk assessments and food legislation
WHO programmes
ndash INFOSAN ndash rapid risk assessment information notes
ndash drinking water guidelines
ndash WHOPES (public health use of pesticides)
ndash Childrens environmental health
ndash Global Alert and Response
International RA method development and harmonization
Principles and Methods
EHC 240 Principles and methods for the risk assessment of chemicals in food WHO 2009
Risk assessment guidance for all food chemicals
Guidance on interpretation of studies and general assessments
Descriptive guidance not prescriptive
Electronic publication in individual chapters ndash for update
httpwwwwhointfoodsafetychemprinciplesenindex1html
WHO databases httpwwwwhointfoodsafetydatabasesen
JECFA and JMPR databases
httpappswhointfood-additives-contaminants-jecfa-databasesearchaspx
httpappswhointpesticide-residues-jmpr-database
JECFA and JMPR databases - FAO
httpwwwfaoorgfoodfood-safety-qualityscientific-advicejecfaen
httpwwwfaoorgagriculturecropsthematic-sitemapthemepestslpeen
22 |
Thank you
Question
Risk Assessment A Scientific Process
Hazard Identification
Hazard Characterization
Exposure Assessment
Risk Characterization
Problem Formulation RM
RA
Risk =
Hazard x Exposure
4 |
Example of chemical risk assessment
5 |
Main Question in Food Safety
What is a bdquosaferdquo human exposure over lifetime
eg a dose with rdquono appreciable or a negligible riskrdquo
BUT for some scenarioscompounds also acute risks relevant
6 |
General considerations re RA
Identify problems - prioritization
Define the scope
Relevant expertise ndash chemists toxicologists epidemiologists modellersstatisticians
veterinarians etc
Interaction between risk assessor and risk manager ndash common understanding of problem
Recognise limitations in data resources - be transparent
Take the whole database into account - integrate results
WHO
Hazard
Assessment
Exposure
Assessment
Key NOAEL
Uncertainty
factors
Safety standard
(Health based guidance value)
eg ADI=NOAELUfs
Chemical
analysis
Food
consumption
X
Exposure
Safety assurance
Exposure lt ADI
Exposure gt ADI Management
Decision
8 |
A process to determine
possible adverse
effects of a chemical on
the organism1
- hazard identification
- hazard characterization
Hazard Assessment
1 adapted from EHC 240 Principles and methods for the risk assessment of chemicals in food Annex 1 Glossary of terms FAOWHO 2009
httpappswhointirisbitstream106654406513WHO_EHC_240_13_eng_Annex1pdfua=1
9
Hazard Assessment
Assessment Procedure Identification of critical endpointeffect and
critical studydata set ndash most sensitive species most sensitive endpoint of
relevance to humans most relevant epidemiological study
Dose-response analysis (Point of Departure) ndash NoLow Observed Adverse Effect Level (NLOAEL)
Benchmark Dose (BMD BMDL)
Identification of uncertainties assignment of uncertaintysafety factors
Outcome Health based guidance value (ADI TDI ARfD)
quantitative risk at specific exposure qualitative descriptor other guidance to risk manager (eg MOE)
10 |
ldquohellip the qualitative
andor quantitative
evaluation of the likely
intake of biological
chemical and physical
agents via food helliprdquo1
Dietary Exposure Assessment
1 The Codex Alimentarius Commissionrsquos (CAC) Procedural Manual (FAOWHO 2008a)
11 |
Dietary Exposure Assessment
Combining food consumption data with occurrence of chemical in food
Deterministic approach (point estimate)
Probabilistic approach (distribution)
Outcome ndash Estimated mean and high dietary exposures
ndash Identification of specific sub-groups
ndash Identification of key exposure sources
Reference httpwwwwhointfoodsafetychemjecfaenintake_guidelinespdf
12 |
Types of Risk Assessment
Rapid risk assessment ndash emergencies
Qualitative RA ndash due to lack of data or lack of health concern
Quantitative RA ndash derivation of guidance value or full expression of probability of adverse health outcome at defined level of exposure
Dat
a an
d r
eso
urc
e n
eed
s
13
Hazard assessment
Biochemical data - Absorption distribution excretion metabolism effects on enzymes
Toxicological data ndash Acute short-term long-term toxicity amp carcinogenicity (mainly rats and
mice sometimes dogs) ndash Genotoxicity (in vitro and in vivo) ndash Reproductive and developmental toxicity (mainly rats) ndash Special studies (eg immunotoxicity cardiovascular effects thyroid
function)
Observations in humans
What are data
Independant of geographic origin
14
Exposure assessment
Food consumption data - Average high consumption different age groups
Occurrence data ndash Amount in food (raw processedhellip)
What are data
Country region dietary habit specific
15 |
Where do data come from
- Regulatory data submission by manufacturer
For compounds intentionally added to foods
- Data from governments
- Monitoring data epidemiological data research data
- Open scientific literature
- Experimental research human data
16 |
ADITDI
Level of health concern
Sources of exposure
Prioritization
Codex Alimentarius Commission
Toxicology amp Epidemiology
(WHO)
Chemistry Analytics (FAO)
JECFA
General procedure and interaction
FAOWHO
Secretariat to
schedule meetings
Call for data
Call for experts
Standards Recommendations
17 |
Scientific advice work feeds into
Codex standard setting process
Nationalregional risk assessments and food legislation
WHO programmes
ndash INFOSAN ndash rapid risk assessment information notes
ndash drinking water guidelines
ndash WHOPES (public health use of pesticides)
ndash Childrens environmental health
ndash Global Alert and Response
International RA method development and harmonization
Principles and Methods
EHC 240 Principles and methods for the risk assessment of chemicals in food WHO 2009
Risk assessment guidance for all food chemicals
Guidance on interpretation of studies and general assessments
Descriptive guidance not prescriptive
Electronic publication in individual chapters ndash for update
httpwwwwhointfoodsafetychemprinciplesenindex1html
WHO databases httpwwwwhointfoodsafetydatabasesen
JECFA and JMPR databases
httpappswhointfood-additives-contaminants-jecfa-databasesearchaspx
httpappswhointpesticide-residues-jmpr-database
JECFA and JMPR databases - FAO
httpwwwfaoorgfoodfood-safety-qualityscientific-advicejecfaen
httpwwwfaoorgagriculturecropsthematic-sitemapthemepestslpeen
22 |
Thank you
Question
4 |
Example of chemical risk assessment
5 |
Main Question in Food Safety
What is a bdquosaferdquo human exposure over lifetime
eg a dose with rdquono appreciable or a negligible riskrdquo
BUT for some scenarioscompounds also acute risks relevant
6 |
General considerations re RA
Identify problems - prioritization
Define the scope
Relevant expertise ndash chemists toxicologists epidemiologists modellersstatisticians
veterinarians etc
Interaction between risk assessor and risk manager ndash common understanding of problem
Recognise limitations in data resources - be transparent
Take the whole database into account - integrate results
WHO
Hazard
Assessment
Exposure
Assessment
Key NOAEL
Uncertainty
factors
Safety standard
(Health based guidance value)
eg ADI=NOAELUfs
Chemical
analysis
Food
consumption
X
Exposure
Safety assurance
Exposure lt ADI
Exposure gt ADI Management
Decision
8 |
A process to determine
possible adverse
effects of a chemical on
the organism1
- hazard identification
- hazard characterization
Hazard Assessment
1 adapted from EHC 240 Principles and methods for the risk assessment of chemicals in food Annex 1 Glossary of terms FAOWHO 2009
httpappswhointirisbitstream106654406513WHO_EHC_240_13_eng_Annex1pdfua=1
9
Hazard Assessment
Assessment Procedure Identification of critical endpointeffect and
critical studydata set ndash most sensitive species most sensitive endpoint of
relevance to humans most relevant epidemiological study
Dose-response analysis (Point of Departure) ndash NoLow Observed Adverse Effect Level (NLOAEL)
Benchmark Dose (BMD BMDL)
Identification of uncertainties assignment of uncertaintysafety factors
Outcome Health based guidance value (ADI TDI ARfD)
quantitative risk at specific exposure qualitative descriptor other guidance to risk manager (eg MOE)
10 |
ldquohellip the qualitative
andor quantitative
evaluation of the likely
intake of biological
chemical and physical
agents via food helliprdquo1
Dietary Exposure Assessment
1 The Codex Alimentarius Commissionrsquos (CAC) Procedural Manual (FAOWHO 2008a)
11 |
Dietary Exposure Assessment
Combining food consumption data with occurrence of chemical in food
Deterministic approach (point estimate)
Probabilistic approach (distribution)
Outcome ndash Estimated mean and high dietary exposures
ndash Identification of specific sub-groups
ndash Identification of key exposure sources
Reference httpwwwwhointfoodsafetychemjecfaenintake_guidelinespdf
12 |
Types of Risk Assessment
Rapid risk assessment ndash emergencies
Qualitative RA ndash due to lack of data or lack of health concern
Quantitative RA ndash derivation of guidance value or full expression of probability of adverse health outcome at defined level of exposure
Dat
a an
d r
eso
urc
e n
eed
s
13
Hazard assessment
Biochemical data - Absorption distribution excretion metabolism effects on enzymes
Toxicological data ndash Acute short-term long-term toxicity amp carcinogenicity (mainly rats and
mice sometimes dogs) ndash Genotoxicity (in vitro and in vivo) ndash Reproductive and developmental toxicity (mainly rats) ndash Special studies (eg immunotoxicity cardiovascular effects thyroid
function)
Observations in humans
What are data
Independant of geographic origin
14
Exposure assessment
Food consumption data - Average high consumption different age groups
Occurrence data ndash Amount in food (raw processedhellip)
What are data
Country region dietary habit specific
15 |
Where do data come from
- Regulatory data submission by manufacturer
For compounds intentionally added to foods
- Data from governments
- Monitoring data epidemiological data research data
- Open scientific literature
- Experimental research human data
16 |
ADITDI
Level of health concern
Sources of exposure
Prioritization
Codex Alimentarius Commission
Toxicology amp Epidemiology
(WHO)
Chemistry Analytics (FAO)
JECFA
General procedure and interaction
FAOWHO
Secretariat to
schedule meetings
Call for data
Call for experts
Standards Recommendations
17 |
Scientific advice work feeds into
Codex standard setting process
Nationalregional risk assessments and food legislation
WHO programmes
ndash INFOSAN ndash rapid risk assessment information notes
ndash drinking water guidelines
ndash WHOPES (public health use of pesticides)
ndash Childrens environmental health
ndash Global Alert and Response
International RA method development and harmonization
Principles and Methods
EHC 240 Principles and methods for the risk assessment of chemicals in food WHO 2009
Risk assessment guidance for all food chemicals
Guidance on interpretation of studies and general assessments
Descriptive guidance not prescriptive
Electronic publication in individual chapters ndash for update
httpwwwwhointfoodsafetychemprinciplesenindex1html
WHO databases httpwwwwhointfoodsafetydatabasesen
JECFA and JMPR databases
httpappswhointfood-additives-contaminants-jecfa-databasesearchaspx
httpappswhointpesticide-residues-jmpr-database
JECFA and JMPR databases - FAO
httpwwwfaoorgfoodfood-safety-qualityscientific-advicejecfaen
httpwwwfaoorgagriculturecropsthematic-sitemapthemepestslpeen
22 |
Thank you
Question
5 |
Main Question in Food Safety
What is a bdquosaferdquo human exposure over lifetime
eg a dose with rdquono appreciable or a negligible riskrdquo
BUT for some scenarioscompounds also acute risks relevant
6 |
General considerations re RA
Identify problems - prioritization
Define the scope
Relevant expertise ndash chemists toxicologists epidemiologists modellersstatisticians
veterinarians etc
Interaction between risk assessor and risk manager ndash common understanding of problem
Recognise limitations in data resources - be transparent
Take the whole database into account - integrate results
WHO
Hazard
Assessment
Exposure
Assessment
Key NOAEL
Uncertainty
factors
Safety standard
(Health based guidance value)
eg ADI=NOAELUfs
Chemical
analysis
Food
consumption
X
Exposure
Safety assurance
Exposure lt ADI
Exposure gt ADI Management
Decision
8 |
A process to determine
possible adverse
effects of a chemical on
the organism1
- hazard identification
- hazard characterization
Hazard Assessment
1 adapted from EHC 240 Principles and methods for the risk assessment of chemicals in food Annex 1 Glossary of terms FAOWHO 2009
httpappswhointirisbitstream106654406513WHO_EHC_240_13_eng_Annex1pdfua=1
9
Hazard Assessment
Assessment Procedure Identification of critical endpointeffect and
critical studydata set ndash most sensitive species most sensitive endpoint of
relevance to humans most relevant epidemiological study
Dose-response analysis (Point of Departure) ndash NoLow Observed Adverse Effect Level (NLOAEL)
Benchmark Dose (BMD BMDL)
Identification of uncertainties assignment of uncertaintysafety factors
Outcome Health based guidance value (ADI TDI ARfD)
quantitative risk at specific exposure qualitative descriptor other guidance to risk manager (eg MOE)
10 |
ldquohellip the qualitative
andor quantitative
evaluation of the likely
intake of biological
chemical and physical
agents via food helliprdquo1
Dietary Exposure Assessment
1 The Codex Alimentarius Commissionrsquos (CAC) Procedural Manual (FAOWHO 2008a)
11 |
Dietary Exposure Assessment
Combining food consumption data with occurrence of chemical in food
Deterministic approach (point estimate)
Probabilistic approach (distribution)
Outcome ndash Estimated mean and high dietary exposures
ndash Identification of specific sub-groups
ndash Identification of key exposure sources
Reference httpwwwwhointfoodsafetychemjecfaenintake_guidelinespdf
12 |
Types of Risk Assessment
Rapid risk assessment ndash emergencies
Qualitative RA ndash due to lack of data or lack of health concern
Quantitative RA ndash derivation of guidance value or full expression of probability of adverse health outcome at defined level of exposure
Dat
a an
d r
eso
urc
e n
eed
s
13
Hazard assessment
Biochemical data - Absorption distribution excretion metabolism effects on enzymes
Toxicological data ndash Acute short-term long-term toxicity amp carcinogenicity (mainly rats and
mice sometimes dogs) ndash Genotoxicity (in vitro and in vivo) ndash Reproductive and developmental toxicity (mainly rats) ndash Special studies (eg immunotoxicity cardiovascular effects thyroid
function)
Observations in humans
What are data
Independant of geographic origin
14
Exposure assessment
Food consumption data - Average high consumption different age groups
Occurrence data ndash Amount in food (raw processedhellip)
What are data
Country region dietary habit specific
15 |
Where do data come from
- Regulatory data submission by manufacturer
For compounds intentionally added to foods
- Data from governments
- Monitoring data epidemiological data research data
- Open scientific literature
- Experimental research human data
16 |
ADITDI
Level of health concern
Sources of exposure
Prioritization
Codex Alimentarius Commission
Toxicology amp Epidemiology
(WHO)
Chemistry Analytics (FAO)
JECFA
General procedure and interaction
FAOWHO
Secretariat to
schedule meetings
Call for data
Call for experts
Standards Recommendations
17 |
Scientific advice work feeds into
Codex standard setting process
Nationalregional risk assessments and food legislation
WHO programmes
ndash INFOSAN ndash rapid risk assessment information notes
ndash drinking water guidelines
ndash WHOPES (public health use of pesticides)
ndash Childrens environmental health
ndash Global Alert and Response
International RA method development and harmonization
Principles and Methods
EHC 240 Principles and methods for the risk assessment of chemicals in food WHO 2009
Risk assessment guidance for all food chemicals
Guidance on interpretation of studies and general assessments
Descriptive guidance not prescriptive
Electronic publication in individual chapters ndash for update
httpwwwwhointfoodsafetychemprinciplesenindex1html
WHO databases httpwwwwhointfoodsafetydatabasesen
JECFA and JMPR databases
httpappswhointfood-additives-contaminants-jecfa-databasesearchaspx
httpappswhointpesticide-residues-jmpr-database
JECFA and JMPR databases - FAO
httpwwwfaoorgfoodfood-safety-qualityscientific-advicejecfaen
httpwwwfaoorgagriculturecropsthematic-sitemapthemepestslpeen
22 |
Thank you
Question
6 |
General considerations re RA
Identify problems - prioritization
Define the scope
Relevant expertise ndash chemists toxicologists epidemiologists modellersstatisticians
veterinarians etc
Interaction between risk assessor and risk manager ndash common understanding of problem
Recognise limitations in data resources - be transparent
Take the whole database into account - integrate results
WHO
Hazard
Assessment
Exposure
Assessment
Key NOAEL
Uncertainty
factors
Safety standard
(Health based guidance value)
eg ADI=NOAELUfs
Chemical
analysis
Food
consumption
X
Exposure
Safety assurance
Exposure lt ADI
Exposure gt ADI Management
Decision
8 |
A process to determine
possible adverse
effects of a chemical on
the organism1
- hazard identification
- hazard characterization
Hazard Assessment
1 adapted from EHC 240 Principles and methods for the risk assessment of chemicals in food Annex 1 Glossary of terms FAOWHO 2009
httpappswhointirisbitstream106654406513WHO_EHC_240_13_eng_Annex1pdfua=1
9
Hazard Assessment
Assessment Procedure Identification of critical endpointeffect and
critical studydata set ndash most sensitive species most sensitive endpoint of
relevance to humans most relevant epidemiological study
Dose-response analysis (Point of Departure) ndash NoLow Observed Adverse Effect Level (NLOAEL)
Benchmark Dose (BMD BMDL)
Identification of uncertainties assignment of uncertaintysafety factors
Outcome Health based guidance value (ADI TDI ARfD)
quantitative risk at specific exposure qualitative descriptor other guidance to risk manager (eg MOE)
10 |
ldquohellip the qualitative
andor quantitative
evaluation of the likely
intake of biological
chemical and physical
agents via food helliprdquo1
Dietary Exposure Assessment
1 The Codex Alimentarius Commissionrsquos (CAC) Procedural Manual (FAOWHO 2008a)
11 |
Dietary Exposure Assessment
Combining food consumption data with occurrence of chemical in food
Deterministic approach (point estimate)
Probabilistic approach (distribution)
Outcome ndash Estimated mean and high dietary exposures
ndash Identification of specific sub-groups
ndash Identification of key exposure sources
Reference httpwwwwhointfoodsafetychemjecfaenintake_guidelinespdf
12 |
Types of Risk Assessment
Rapid risk assessment ndash emergencies
Qualitative RA ndash due to lack of data or lack of health concern
Quantitative RA ndash derivation of guidance value or full expression of probability of adverse health outcome at defined level of exposure
Dat
a an
d r
eso
urc
e n
eed
s
13
Hazard assessment
Biochemical data - Absorption distribution excretion metabolism effects on enzymes
Toxicological data ndash Acute short-term long-term toxicity amp carcinogenicity (mainly rats and
mice sometimes dogs) ndash Genotoxicity (in vitro and in vivo) ndash Reproductive and developmental toxicity (mainly rats) ndash Special studies (eg immunotoxicity cardiovascular effects thyroid
function)
Observations in humans
What are data
Independant of geographic origin
14
Exposure assessment
Food consumption data - Average high consumption different age groups
Occurrence data ndash Amount in food (raw processedhellip)
What are data
Country region dietary habit specific
15 |
Where do data come from
- Regulatory data submission by manufacturer
For compounds intentionally added to foods
- Data from governments
- Monitoring data epidemiological data research data
- Open scientific literature
- Experimental research human data
16 |
ADITDI
Level of health concern
Sources of exposure
Prioritization
Codex Alimentarius Commission
Toxicology amp Epidemiology
(WHO)
Chemistry Analytics (FAO)
JECFA
General procedure and interaction
FAOWHO
Secretariat to
schedule meetings
Call for data
Call for experts
Standards Recommendations
17 |
Scientific advice work feeds into
Codex standard setting process
Nationalregional risk assessments and food legislation
WHO programmes
ndash INFOSAN ndash rapid risk assessment information notes
ndash drinking water guidelines
ndash WHOPES (public health use of pesticides)
ndash Childrens environmental health
ndash Global Alert and Response
International RA method development and harmonization
Principles and Methods
EHC 240 Principles and methods for the risk assessment of chemicals in food WHO 2009
Risk assessment guidance for all food chemicals
Guidance on interpretation of studies and general assessments
Descriptive guidance not prescriptive
Electronic publication in individual chapters ndash for update
httpwwwwhointfoodsafetychemprinciplesenindex1html
WHO databases httpwwwwhointfoodsafetydatabasesen
JECFA and JMPR databases
httpappswhointfood-additives-contaminants-jecfa-databasesearchaspx
httpappswhointpesticide-residues-jmpr-database
JECFA and JMPR databases - FAO
httpwwwfaoorgfoodfood-safety-qualityscientific-advicejecfaen
httpwwwfaoorgagriculturecropsthematic-sitemapthemepestslpeen
22 |
Thank you
Question
WHO
Hazard
Assessment
Exposure
Assessment
Key NOAEL
Uncertainty
factors
Safety standard
(Health based guidance value)
eg ADI=NOAELUfs
Chemical
analysis
Food
consumption
X
Exposure
Safety assurance
Exposure lt ADI
Exposure gt ADI Management
Decision
8 |
A process to determine
possible adverse
effects of a chemical on
the organism1
- hazard identification
- hazard characterization
Hazard Assessment
1 adapted from EHC 240 Principles and methods for the risk assessment of chemicals in food Annex 1 Glossary of terms FAOWHO 2009
httpappswhointirisbitstream106654406513WHO_EHC_240_13_eng_Annex1pdfua=1
9
Hazard Assessment
Assessment Procedure Identification of critical endpointeffect and
critical studydata set ndash most sensitive species most sensitive endpoint of
relevance to humans most relevant epidemiological study
Dose-response analysis (Point of Departure) ndash NoLow Observed Adverse Effect Level (NLOAEL)
Benchmark Dose (BMD BMDL)
Identification of uncertainties assignment of uncertaintysafety factors
Outcome Health based guidance value (ADI TDI ARfD)
quantitative risk at specific exposure qualitative descriptor other guidance to risk manager (eg MOE)
10 |
ldquohellip the qualitative
andor quantitative
evaluation of the likely
intake of biological
chemical and physical
agents via food helliprdquo1
Dietary Exposure Assessment
1 The Codex Alimentarius Commissionrsquos (CAC) Procedural Manual (FAOWHO 2008a)
11 |
Dietary Exposure Assessment
Combining food consumption data with occurrence of chemical in food
Deterministic approach (point estimate)
Probabilistic approach (distribution)
Outcome ndash Estimated mean and high dietary exposures
ndash Identification of specific sub-groups
ndash Identification of key exposure sources
Reference httpwwwwhointfoodsafetychemjecfaenintake_guidelinespdf
12 |
Types of Risk Assessment
Rapid risk assessment ndash emergencies
Qualitative RA ndash due to lack of data or lack of health concern
Quantitative RA ndash derivation of guidance value or full expression of probability of adverse health outcome at defined level of exposure
Dat
a an
d r
eso
urc
e n
eed
s
13
Hazard assessment
Biochemical data - Absorption distribution excretion metabolism effects on enzymes
Toxicological data ndash Acute short-term long-term toxicity amp carcinogenicity (mainly rats and
mice sometimes dogs) ndash Genotoxicity (in vitro and in vivo) ndash Reproductive and developmental toxicity (mainly rats) ndash Special studies (eg immunotoxicity cardiovascular effects thyroid
function)
Observations in humans
What are data
Independant of geographic origin
14
Exposure assessment
Food consumption data - Average high consumption different age groups
Occurrence data ndash Amount in food (raw processedhellip)
What are data
Country region dietary habit specific
15 |
Where do data come from
- Regulatory data submission by manufacturer
For compounds intentionally added to foods
- Data from governments
- Monitoring data epidemiological data research data
- Open scientific literature
- Experimental research human data
16 |
ADITDI
Level of health concern
Sources of exposure
Prioritization
Codex Alimentarius Commission
Toxicology amp Epidemiology
(WHO)
Chemistry Analytics (FAO)
JECFA
General procedure and interaction
FAOWHO
Secretariat to
schedule meetings
Call for data
Call for experts
Standards Recommendations
17 |
Scientific advice work feeds into
Codex standard setting process
Nationalregional risk assessments and food legislation
WHO programmes
ndash INFOSAN ndash rapid risk assessment information notes
ndash drinking water guidelines
ndash WHOPES (public health use of pesticides)
ndash Childrens environmental health
ndash Global Alert and Response
International RA method development and harmonization
Principles and Methods
EHC 240 Principles and methods for the risk assessment of chemicals in food WHO 2009
Risk assessment guidance for all food chemicals
Guidance on interpretation of studies and general assessments
Descriptive guidance not prescriptive
Electronic publication in individual chapters ndash for update
httpwwwwhointfoodsafetychemprinciplesenindex1html
WHO databases httpwwwwhointfoodsafetydatabasesen
JECFA and JMPR databases
httpappswhointfood-additives-contaminants-jecfa-databasesearchaspx
httpappswhointpesticide-residues-jmpr-database
JECFA and JMPR databases - FAO
httpwwwfaoorgfoodfood-safety-qualityscientific-advicejecfaen
httpwwwfaoorgagriculturecropsthematic-sitemapthemepestslpeen
22 |
Thank you
Question
8 |
A process to determine
possible adverse
effects of a chemical on
the organism1
- hazard identification
- hazard characterization
Hazard Assessment
1 adapted from EHC 240 Principles and methods for the risk assessment of chemicals in food Annex 1 Glossary of terms FAOWHO 2009
httpappswhointirisbitstream106654406513WHO_EHC_240_13_eng_Annex1pdfua=1
9
Hazard Assessment
Assessment Procedure Identification of critical endpointeffect and
critical studydata set ndash most sensitive species most sensitive endpoint of
relevance to humans most relevant epidemiological study
Dose-response analysis (Point of Departure) ndash NoLow Observed Adverse Effect Level (NLOAEL)
Benchmark Dose (BMD BMDL)
Identification of uncertainties assignment of uncertaintysafety factors
Outcome Health based guidance value (ADI TDI ARfD)
quantitative risk at specific exposure qualitative descriptor other guidance to risk manager (eg MOE)
10 |
ldquohellip the qualitative
andor quantitative
evaluation of the likely
intake of biological
chemical and physical
agents via food helliprdquo1
Dietary Exposure Assessment
1 The Codex Alimentarius Commissionrsquos (CAC) Procedural Manual (FAOWHO 2008a)
11 |
Dietary Exposure Assessment
Combining food consumption data with occurrence of chemical in food
Deterministic approach (point estimate)
Probabilistic approach (distribution)
Outcome ndash Estimated mean and high dietary exposures
ndash Identification of specific sub-groups
ndash Identification of key exposure sources
Reference httpwwwwhointfoodsafetychemjecfaenintake_guidelinespdf
12 |
Types of Risk Assessment
Rapid risk assessment ndash emergencies
Qualitative RA ndash due to lack of data or lack of health concern
Quantitative RA ndash derivation of guidance value or full expression of probability of adverse health outcome at defined level of exposure
Dat
a an
d r
eso
urc
e n
eed
s
13
Hazard assessment
Biochemical data - Absorption distribution excretion metabolism effects on enzymes
Toxicological data ndash Acute short-term long-term toxicity amp carcinogenicity (mainly rats and
mice sometimes dogs) ndash Genotoxicity (in vitro and in vivo) ndash Reproductive and developmental toxicity (mainly rats) ndash Special studies (eg immunotoxicity cardiovascular effects thyroid
function)
Observations in humans
What are data
Independant of geographic origin
14
Exposure assessment
Food consumption data - Average high consumption different age groups
Occurrence data ndash Amount in food (raw processedhellip)
What are data
Country region dietary habit specific
15 |
Where do data come from
- Regulatory data submission by manufacturer
For compounds intentionally added to foods
- Data from governments
- Monitoring data epidemiological data research data
- Open scientific literature
- Experimental research human data
16 |
ADITDI
Level of health concern
Sources of exposure
Prioritization
Codex Alimentarius Commission
Toxicology amp Epidemiology
(WHO)
Chemistry Analytics (FAO)
JECFA
General procedure and interaction
FAOWHO
Secretariat to
schedule meetings
Call for data
Call for experts
Standards Recommendations
17 |
Scientific advice work feeds into
Codex standard setting process
Nationalregional risk assessments and food legislation
WHO programmes
ndash INFOSAN ndash rapid risk assessment information notes
ndash drinking water guidelines
ndash WHOPES (public health use of pesticides)
ndash Childrens environmental health
ndash Global Alert and Response
International RA method development and harmonization
Principles and Methods
EHC 240 Principles and methods for the risk assessment of chemicals in food WHO 2009
Risk assessment guidance for all food chemicals
Guidance on interpretation of studies and general assessments
Descriptive guidance not prescriptive
Electronic publication in individual chapters ndash for update
httpwwwwhointfoodsafetychemprinciplesenindex1html
WHO databases httpwwwwhointfoodsafetydatabasesen
JECFA and JMPR databases
httpappswhointfood-additives-contaminants-jecfa-databasesearchaspx
httpappswhointpesticide-residues-jmpr-database
JECFA and JMPR databases - FAO
httpwwwfaoorgfoodfood-safety-qualityscientific-advicejecfaen
httpwwwfaoorgagriculturecropsthematic-sitemapthemepestslpeen
22 |
Thank you
Question
9
Hazard Assessment
Assessment Procedure Identification of critical endpointeffect and
critical studydata set ndash most sensitive species most sensitive endpoint of
relevance to humans most relevant epidemiological study
Dose-response analysis (Point of Departure) ndash NoLow Observed Adverse Effect Level (NLOAEL)
Benchmark Dose (BMD BMDL)
Identification of uncertainties assignment of uncertaintysafety factors
Outcome Health based guidance value (ADI TDI ARfD)
quantitative risk at specific exposure qualitative descriptor other guidance to risk manager (eg MOE)
10 |
ldquohellip the qualitative
andor quantitative
evaluation of the likely
intake of biological
chemical and physical
agents via food helliprdquo1
Dietary Exposure Assessment
1 The Codex Alimentarius Commissionrsquos (CAC) Procedural Manual (FAOWHO 2008a)
11 |
Dietary Exposure Assessment
Combining food consumption data with occurrence of chemical in food
Deterministic approach (point estimate)
Probabilistic approach (distribution)
Outcome ndash Estimated mean and high dietary exposures
ndash Identification of specific sub-groups
ndash Identification of key exposure sources
Reference httpwwwwhointfoodsafetychemjecfaenintake_guidelinespdf
12 |
Types of Risk Assessment
Rapid risk assessment ndash emergencies
Qualitative RA ndash due to lack of data or lack of health concern
Quantitative RA ndash derivation of guidance value or full expression of probability of adverse health outcome at defined level of exposure
Dat
a an
d r
eso
urc
e n
eed
s
13
Hazard assessment
Biochemical data - Absorption distribution excretion metabolism effects on enzymes
Toxicological data ndash Acute short-term long-term toxicity amp carcinogenicity (mainly rats and
mice sometimes dogs) ndash Genotoxicity (in vitro and in vivo) ndash Reproductive and developmental toxicity (mainly rats) ndash Special studies (eg immunotoxicity cardiovascular effects thyroid
function)
Observations in humans
What are data
Independant of geographic origin
14
Exposure assessment
Food consumption data - Average high consumption different age groups
Occurrence data ndash Amount in food (raw processedhellip)
What are data
Country region dietary habit specific
15 |
Where do data come from
- Regulatory data submission by manufacturer
For compounds intentionally added to foods
- Data from governments
- Monitoring data epidemiological data research data
- Open scientific literature
- Experimental research human data
16 |
ADITDI
Level of health concern
Sources of exposure
Prioritization
Codex Alimentarius Commission
Toxicology amp Epidemiology
(WHO)
Chemistry Analytics (FAO)
JECFA
General procedure and interaction
FAOWHO
Secretariat to
schedule meetings
Call for data
Call for experts
Standards Recommendations
17 |
Scientific advice work feeds into
Codex standard setting process
Nationalregional risk assessments and food legislation
WHO programmes
ndash INFOSAN ndash rapid risk assessment information notes
ndash drinking water guidelines
ndash WHOPES (public health use of pesticides)
ndash Childrens environmental health
ndash Global Alert and Response
International RA method development and harmonization
Principles and Methods
EHC 240 Principles and methods for the risk assessment of chemicals in food WHO 2009
Risk assessment guidance for all food chemicals
Guidance on interpretation of studies and general assessments
Descriptive guidance not prescriptive
Electronic publication in individual chapters ndash for update
httpwwwwhointfoodsafetychemprinciplesenindex1html
WHO databases httpwwwwhointfoodsafetydatabasesen
JECFA and JMPR databases
httpappswhointfood-additives-contaminants-jecfa-databasesearchaspx
httpappswhointpesticide-residues-jmpr-database
JECFA and JMPR databases - FAO
httpwwwfaoorgfoodfood-safety-qualityscientific-advicejecfaen
httpwwwfaoorgagriculturecropsthematic-sitemapthemepestslpeen
22 |
Thank you
Question
10 |
ldquohellip the qualitative
andor quantitative
evaluation of the likely
intake of biological
chemical and physical
agents via food helliprdquo1
Dietary Exposure Assessment
1 The Codex Alimentarius Commissionrsquos (CAC) Procedural Manual (FAOWHO 2008a)
11 |
Dietary Exposure Assessment
Combining food consumption data with occurrence of chemical in food
Deterministic approach (point estimate)
Probabilistic approach (distribution)
Outcome ndash Estimated mean and high dietary exposures
ndash Identification of specific sub-groups
ndash Identification of key exposure sources
Reference httpwwwwhointfoodsafetychemjecfaenintake_guidelinespdf
12 |
Types of Risk Assessment
Rapid risk assessment ndash emergencies
Qualitative RA ndash due to lack of data or lack of health concern
Quantitative RA ndash derivation of guidance value or full expression of probability of adverse health outcome at defined level of exposure
Dat
a an
d r
eso
urc
e n
eed
s
13
Hazard assessment
Biochemical data - Absorption distribution excretion metabolism effects on enzymes
Toxicological data ndash Acute short-term long-term toxicity amp carcinogenicity (mainly rats and
mice sometimes dogs) ndash Genotoxicity (in vitro and in vivo) ndash Reproductive and developmental toxicity (mainly rats) ndash Special studies (eg immunotoxicity cardiovascular effects thyroid
function)
Observations in humans
What are data
Independant of geographic origin
14
Exposure assessment
Food consumption data - Average high consumption different age groups
Occurrence data ndash Amount in food (raw processedhellip)
What are data
Country region dietary habit specific
15 |
Where do data come from
- Regulatory data submission by manufacturer
For compounds intentionally added to foods
- Data from governments
- Monitoring data epidemiological data research data
- Open scientific literature
- Experimental research human data
16 |
ADITDI
Level of health concern
Sources of exposure
Prioritization
Codex Alimentarius Commission
Toxicology amp Epidemiology
(WHO)
Chemistry Analytics (FAO)
JECFA
General procedure and interaction
FAOWHO
Secretariat to
schedule meetings
Call for data
Call for experts
Standards Recommendations
17 |
Scientific advice work feeds into
Codex standard setting process
Nationalregional risk assessments and food legislation
WHO programmes
ndash INFOSAN ndash rapid risk assessment information notes
ndash drinking water guidelines
ndash WHOPES (public health use of pesticides)
ndash Childrens environmental health
ndash Global Alert and Response
International RA method development and harmonization
Principles and Methods
EHC 240 Principles and methods for the risk assessment of chemicals in food WHO 2009
Risk assessment guidance for all food chemicals
Guidance on interpretation of studies and general assessments
Descriptive guidance not prescriptive
Electronic publication in individual chapters ndash for update
httpwwwwhointfoodsafetychemprinciplesenindex1html
WHO databases httpwwwwhointfoodsafetydatabasesen
JECFA and JMPR databases
httpappswhointfood-additives-contaminants-jecfa-databasesearchaspx
httpappswhointpesticide-residues-jmpr-database
JECFA and JMPR databases - FAO
httpwwwfaoorgfoodfood-safety-qualityscientific-advicejecfaen
httpwwwfaoorgagriculturecropsthematic-sitemapthemepestslpeen
22 |
Thank you
Question
11 |
Dietary Exposure Assessment
Combining food consumption data with occurrence of chemical in food
Deterministic approach (point estimate)
Probabilistic approach (distribution)
Outcome ndash Estimated mean and high dietary exposures
ndash Identification of specific sub-groups
ndash Identification of key exposure sources
Reference httpwwwwhointfoodsafetychemjecfaenintake_guidelinespdf
12 |
Types of Risk Assessment
Rapid risk assessment ndash emergencies
Qualitative RA ndash due to lack of data or lack of health concern
Quantitative RA ndash derivation of guidance value or full expression of probability of adverse health outcome at defined level of exposure
Dat
a an
d r
eso
urc
e n
eed
s
13
Hazard assessment
Biochemical data - Absorption distribution excretion metabolism effects on enzymes
Toxicological data ndash Acute short-term long-term toxicity amp carcinogenicity (mainly rats and
mice sometimes dogs) ndash Genotoxicity (in vitro and in vivo) ndash Reproductive and developmental toxicity (mainly rats) ndash Special studies (eg immunotoxicity cardiovascular effects thyroid
function)
Observations in humans
What are data
Independant of geographic origin
14
Exposure assessment
Food consumption data - Average high consumption different age groups
Occurrence data ndash Amount in food (raw processedhellip)
What are data
Country region dietary habit specific
15 |
Where do data come from
- Regulatory data submission by manufacturer
For compounds intentionally added to foods
- Data from governments
- Monitoring data epidemiological data research data
- Open scientific literature
- Experimental research human data
16 |
ADITDI
Level of health concern
Sources of exposure
Prioritization
Codex Alimentarius Commission
Toxicology amp Epidemiology
(WHO)
Chemistry Analytics (FAO)
JECFA
General procedure and interaction
FAOWHO
Secretariat to
schedule meetings
Call for data
Call for experts
Standards Recommendations
17 |
Scientific advice work feeds into
Codex standard setting process
Nationalregional risk assessments and food legislation
WHO programmes
ndash INFOSAN ndash rapid risk assessment information notes
ndash drinking water guidelines
ndash WHOPES (public health use of pesticides)
ndash Childrens environmental health
ndash Global Alert and Response
International RA method development and harmonization
Principles and Methods
EHC 240 Principles and methods for the risk assessment of chemicals in food WHO 2009
Risk assessment guidance for all food chemicals
Guidance on interpretation of studies and general assessments
Descriptive guidance not prescriptive
Electronic publication in individual chapters ndash for update
httpwwwwhointfoodsafetychemprinciplesenindex1html
WHO databases httpwwwwhointfoodsafetydatabasesen
JECFA and JMPR databases
httpappswhointfood-additives-contaminants-jecfa-databasesearchaspx
httpappswhointpesticide-residues-jmpr-database
JECFA and JMPR databases - FAO
httpwwwfaoorgfoodfood-safety-qualityscientific-advicejecfaen
httpwwwfaoorgagriculturecropsthematic-sitemapthemepestslpeen
22 |
Thank you
Question
12 |
Types of Risk Assessment
Rapid risk assessment ndash emergencies
Qualitative RA ndash due to lack of data or lack of health concern
Quantitative RA ndash derivation of guidance value or full expression of probability of adverse health outcome at defined level of exposure
Dat
a an
d r
eso
urc
e n
eed
s
13
Hazard assessment
Biochemical data - Absorption distribution excretion metabolism effects on enzymes
Toxicological data ndash Acute short-term long-term toxicity amp carcinogenicity (mainly rats and
mice sometimes dogs) ndash Genotoxicity (in vitro and in vivo) ndash Reproductive and developmental toxicity (mainly rats) ndash Special studies (eg immunotoxicity cardiovascular effects thyroid
function)
Observations in humans
What are data
Independant of geographic origin
14
Exposure assessment
Food consumption data - Average high consumption different age groups
Occurrence data ndash Amount in food (raw processedhellip)
What are data
Country region dietary habit specific
15 |
Where do data come from
- Regulatory data submission by manufacturer
For compounds intentionally added to foods
- Data from governments
- Monitoring data epidemiological data research data
- Open scientific literature
- Experimental research human data
16 |
ADITDI
Level of health concern
Sources of exposure
Prioritization
Codex Alimentarius Commission
Toxicology amp Epidemiology
(WHO)
Chemistry Analytics (FAO)
JECFA
General procedure and interaction
FAOWHO
Secretariat to
schedule meetings
Call for data
Call for experts
Standards Recommendations
17 |
Scientific advice work feeds into
Codex standard setting process
Nationalregional risk assessments and food legislation
WHO programmes
ndash INFOSAN ndash rapid risk assessment information notes
ndash drinking water guidelines
ndash WHOPES (public health use of pesticides)
ndash Childrens environmental health
ndash Global Alert and Response
International RA method development and harmonization
Principles and Methods
EHC 240 Principles and methods for the risk assessment of chemicals in food WHO 2009
Risk assessment guidance for all food chemicals
Guidance on interpretation of studies and general assessments
Descriptive guidance not prescriptive
Electronic publication in individual chapters ndash for update
httpwwwwhointfoodsafetychemprinciplesenindex1html
WHO databases httpwwwwhointfoodsafetydatabasesen
JECFA and JMPR databases
httpappswhointfood-additives-contaminants-jecfa-databasesearchaspx
httpappswhointpesticide-residues-jmpr-database
JECFA and JMPR databases - FAO
httpwwwfaoorgfoodfood-safety-qualityscientific-advicejecfaen
httpwwwfaoorgagriculturecropsthematic-sitemapthemepestslpeen
22 |
Thank you
Question
13
Hazard assessment
Biochemical data - Absorption distribution excretion metabolism effects on enzymes
Toxicological data ndash Acute short-term long-term toxicity amp carcinogenicity (mainly rats and
mice sometimes dogs) ndash Genotoxicity (in vitro and in vivo) ndash Reproductive and developmental toxicity (mainly rats) ndash Special studies (eg immunotoxicity cardiovascular effects thyroid
function)
Observations in humans
What are data
Independant of geographic origin
14
Exposure assessment
Food consumption data - Average high consumption different age groups
Occurrence data ndash Amount in food (raw processedhellip)
What are data
Country region dietary habit specific
15 |
Where do data come from
- Regulatory data submission by manufacturer
For compounds intentionally added to foods
- Data from governments
- Monitoring data epidemiological data research data
- Open scientific literature
- Experimental research human data
16 |
ADITDI
Level of health concern
Sources of exposure
Prioritization
Codex Alimentarius Commission
Toxicology amp Epidemiology
(WHO)
Chemistry Analytics (FAO)
JECFA
General procedure and interaction
FAOWHO
Secretariat to
schedule meetings
Call for data
Call for experts
Standards Recommendations
17 |
Scientific advice work feeds into
Codex standard setting process
Nationalregional risk assessments and food legislation
WHO programmes
ndash INFOSAN ndash rapid risk assessment information notes
ndash drinking water guidelines
ndash WHOPES (public health use of pesticides)
ndash Childrens environmental health
ndash Global Alert and Response
International RA method development and harmonization
Principles and Methods
EHC 240 Principles and methods for the risk assessment of chemicals in food WHO 2009
Risk assessment guidance for all food chemicals
Guidance on interpretation of studies and general assessments
Descriptive guidance not prescriptive
Electronic publication in individual chapters ndash for update
httpwwwwhointfoodsafetychemprinciplesenindex1html
WHO databases httpwwwwhointfoodsafetydatabasesen
JECFA and JMPR databases
httpappswhointfood-additives-contaminants-jecfa-databasesearchaspx
httpappswhointpesticide-residues-jmpr-database
JECFA and JMPR databases - FAO
httpwwwfaoorgfoodfood-safety-qualityscientific-advicejecfaen
httpwwwfaoorgagriculturecropsthematic-sitemapthemepestslpeen
22 |
Thank you
Question
14
Exposure assessment
Food consumption data - Average high consumption different age groups
Occurrence data ndash Amount in food (raw processedhellip)
What are data
Country region dietary habit specific
15 |
Where do data come from
- Regulatory data submission by manufacturer
For compounds intentionally added to foods
- Data from governments
- Monitoring data epidemiological data research data
- Open scientific literature
- Experimental research human data
16 |
ADITDI
Level of health concern
Sources of exposure
Prioritization
Codex Alimentarius Commission
Toxicology amp Epidemiology
(WHO)
Chemistry Analytics (FAO)
JECFA
General procedure and interaction
FAOWHO
Secretariat to
schedule meetings
Call for data
Call for experts
Standards Recommendations
17 |
Scientific advice work feeds into
Codex standard setting process
Nationalregional risk assessments and food legislation
WHO programmes
ndash INFOSAN ndash rapid risk assessment information notes
ndash drinking water guidelines
ndash WHOPES (public health use of pesticides)
ndash Childrens environmental health
ndash Global Alert and Response
International RA method development and harmonization
Principles and Methods
EHC 240 Principles and methods for the risk assessment of chemicals in food WHO 2009
Risk assessment guidance for all food chemicals
Guidance on interpretation of studies and general assessments
Descriptive guidance not prescriptive
Electronic publication in individual chapters ndash for update
httpwwwwhointfoodsafetychemprinciplesenindex1html
WHO databases httpwwwwhointfoodsafetydatabasesen
JECFA and JMPR databases
httpappswhointfood-additives-contaminants-jecfa-databasesearchaspx
httpappswhointpesticide-residues-jmpr-database
JECFA and JMPR databases - FAO
httpwwwfaoorgfoodfood-safety-qualityscientific-advicejecfaen
httpwwwfaoorgagriculturecropsthematic-sitemapthemepestslpeen
22 |
Thank you
Question
15 |
Where do data come from
- Regulatory data submission by manufacturer
For compounds intentionally added to foods
- Data from governments
- Monitoring data epidemiological data research data
- Open scientific literature
- Experimental research human data
16 |
ADITDI
Level of health concern
Sources of exposure
Prioritization
Codex Alimentarius Commission
Toxicology amp Epidemiology
(WHO)
Chemistry Analytics (FAO)
JECFA
General procedure and interaction
FAOWHO
Secretariat to
schedule meetings
Call for data
Call for experts
Standards Recommendations
17 |
Scientific advice work feeds into
Codex standard setting process
Nationalregional risk assessments and food legislation
WHO programmes
ndash INFOSAN ndash rapid risk assessment information notes
ndash drinking water guidelines
ndash WHOPES (public health use of pesticides)
ndash Childrens environmental health
ndash Global Alert and Response
International RA method development and harmonization
Principles and Methods
EHC 240 Principles and methods for the risk assessment of chemicals in food WHO 2009
Risk assessment guidance for all food chemicals
Guidance on interpretation of studies and general assessments
Descriptive guidance not prescriptive
Electronic publication in individual chapters ndash for update
httpwwwwhointfoodsafetychemprinciplesenindex1html
WHO databases httpwwwwhointfoodsafetydatabasesen
JECFA and JMPR databases
httpappswhointfood-additives-contaminants-jecfa-databasesearchaspx
httpappswhointpesticide-residues-jmpr-database
JECFA and JMPR databases - FAO
httpwwwfaoorgfoodfood-safety-qualityscientific-advicejecfaen
httpwwwfaoorgagriculturecropsthematic-sitemapthemepestslpeen
22 |
Thank you
Question
16 |
ADITDI
Level of health concern
Sources of exposure
Prioritization
Codex Alimentarius Commission
Toxicology amp Epidemiology
(WHO)
Chemistry Analytics (FAO)
JECFA
General procedure and interaction
FAOWHO
Secretariat to
schedule meetings
Call for data
Call for experts
Standards Recommendations
17 |
Scientific advice work feeds into
Codex standard setting process
Nationalregional risk assessments and food legislation
WHO programmes
ndash INFOSAN ndash rapid risk assessment information notes
ndash drinking water guidelines
ndash WHOPES (public health use of pesticides)
ndash Childrens environmental health
ndash Global Alert and Response
International RA method development and harmonization
Principles and Methods
EHC 240 Principles and methods for the risk assessment of chemicals in food WHO 2009
Risk assessment guidance for all food chemicals
Guidance on interpretation of studies and general assessments
Descriptive guidance not prescriptive
Electronic publication in individual chapters ndash for update
httpwwwwhointfoodsafetychemprinciplesenindex1html
WHO databases httpwwwwhointfoodsafetydatabasesen
JECFA and JMPR databases
httpappswhointfood-additives-contaminants-jecfa-databasesearchaspx
httpappswhointpesticide-residues-jmpr-database
JECFA and JMPR databases - FAO
httpwwwfaoorgfoodfood-safety-qualityscientific-advicejecfaen
httpwwwfaoorgagriculturecropsthematic-sitemapthemepestslpeen
22 |
Thank you
Question
17 |
Scientific advice work feeds into
Codex standard setting process
Nationalregional risk assessments and food legislation
WHO programmes
ndash INFOSAN ndash rapid risk assessment information notes
ndash drinking water guidelines
ndash WHOPES (public health use of pesticides)
ndash Childrens environmental health
ndash Global Alert and Response
International RA method development and harmonization
Principles and Methods
EHC 240 Principles and methods for the risk assessment of chemicals in food WHO 2009
Risk assessment guidance for all food chemicals
Guidance on interpretation of studies and general assessments
Descriptive guidance not prescriptive
Electronic publication in individual chapters ndash for update
httpwwwwhointfoodsafetychemprinciplesenindex1html
WHO databases httpwwwwhointfoodsafetydatabasesen
JECFA and JMPR databases
httpappswhointfood-additives-contaminants-jecfa-databasesearchaspx
httpappswhointpesticide-residues-jmpr-database
JECFA and JMPR databases - FAO
httpwwwfaoorgfoodfood-safety-qualityscientific-advicejecfaen
httpwwwfaoorgagriculturecropsthematic-sitemapthemepestslpeen
22 |
Thank you
Question
Principles and Methods
EHC 240 Principles and methods for the risk assessment of chemicals in food WHO 2009
Risk assessment guidance for all food chemicals
Guidance on interpretation of studies and general assessments
Descriptive guidance not prescriptive
Electronic publication in individual chapters ndash for update
httpwwwwhointfoodsafetychemprinciplesenindex1html
WHO databases httpwwwwhointfoodsafetydatabasesen
JECFA and JMPR databases
httpappswhointfood-additives-contaminants-jecfa-databasesearchaspx
httpappswhointpesticide-residues-jmpr-database
JECFA and JMPR databases - FAO
httpwwwfaoorgfoodfood-safety-qualityscientific-advicejecfaen
httpwwwfaoorgagriculturecropsthematic-sitemapthemepestslpeen
22 |
Thank you
Question
WHO databases httpwwwwhointfoodsafetydatabasesen
JECFA and JMPR databases
httpappswhointfood-additives-contaminants-jecfa-databasesearchaspx
httpappswhointpesticide-residues-jmpr-database
JECFA and JMPR databases - FAO
httpwwwfaoorgfoodfood-safety-qualityscientific-advicejecfaen
httpwwwfaoorgagriculturecropsthematic-sitemapthemepestslpeen
22 |
Thank you
Question
JECFA and JMPR databases
httpappswhointfood-additives-contaminants-jecfa-databasesearchaspx
httpappswhointpesticide-residues-jmpr-database
JECFA and JMPR databases - FAO
httpwwwfaoorgfoodfood-safety-qualityscientific-advicejecfaen
httpwwwfaoorgagriculturecropsthematic-sitemapthemepestslpeen
22 |
Thank you
Question
JECFA and JMPR databases - FAO
httpwwwfaoorgfoodfood-safety-qualityscientific-advicejecfaen
httpwwwfaoorgagriculturecropsthematic-sitemapthemepestslpeen
22 |
Thank you
Question
22 |
Thank you
Question
