© 2024 J. de Jong
Food Safety Risk Assessment (FHM30306)
This summary was written in the academic year 2023-2024, including notes from all lectures
(+slides), background material from previous courses (+2 factsheets) and information from the PC
tutorials.
Contents
Food Safety Risk Assessment (FHM30306) ............................................................................................. 1
Lecture 1: microbiological risk assessment ............................................................................................. 2
Lecture 2: toxicological risk assessment ................................................................................................. 5
Lecture 3: packaging materials ............................................................................................................. 10
Lecture 4: heating of food products...................................................................................................... 12
Lecture 5: gut microbiome and toxicological risks ................................................................................ 14
Lecture 6: mycotoxins ........................................................................................................................... 16
Lecture 7: phytoestrogens .................................................................................................................... 21
Lecture 8: gram-positive pathogens ..................................................................................................... 23
Lecture 9: dose-response models ......................................................................................................... 27
Lecture 10: organic farming .................................................................................................................. 29
Lecture 11: labelling .............................................................................................................................. 31
Lecture 12: tools for microbial risk assessment .................................................................................... 33
Factsheet pathogenic bacteria .............................................................................................................. 39
Cheat sheet definitions ......................................................................................................................... 40
1
, © 2024 J. de Jong
Lecture 1: microbiological risk assessment
Food safety has a major impact on public health and the economy (recalls, lawsuits). It can never
totally be prevented, but it can be reduced. Quantitative objectives are set to control food safety
issues. There is a shared responsibility in society to minimise risk; safety depends on the weakest link
in the food supply chain.
Risk assessment is part of a larger risk analysis.
• Hazard = a biological, chemical or physical agent in food, or condition of food, with the
potential to cause an adverse health effect → potential to cause a risk.
• Risk = a function of the probability of an adverse health effect and the severity of that effect,
consequential to a hazard(s) in food → risk = severity x probability.
Risk analysis
Risk analysis = management concept. Contains:
• Risk assessment = a scientifically based process consisting of
hazard identification, hazard characterization, exposure
assessment and risk characterization. → by scientists.
• Risk management = weighing policy alternatives in the light of
the results of risk assessment, selecting and implementing
appropriate control options → by government, companies,
international trade.
• Risk communication = the interactive exchange of information and opinions throughout the
risk analysis process concerning risk, risk-related factors and risk perceptions, among →
consumers, scientists, risk managers, companies.
Not all levels of all hazards are unsafe → susceptible people require lower dose than healthy adults.
Risk assessment
Risk assessment = characterizing the potential adverse effects to
life and health resulting from exposure to hazards over a specified
time period.
Four steps
1. Which hazards and where? = hazard identification
2. Dose? Illness? = hazard characterisation
3. How many bacteria? = exposure assessment
4. Probability/burden? = risk characterisation
2
, © 2024 J. de Jong
Hazard identification
A good objective procedure is necessary for hazard identification
→ all pathogens; not just expected pathogens. Filtering may be
done by setting certain parameters to reduce the list.
• Rough HI: expected pathogen.
• Detailed HI: X different microorganisms.
Well defined qualitative rules:
1. survival rules: if pasteurisation → remove vegetative organisms.
2. general rules: remove exotic pathogens.
3. cardinal parameters: remove non-growers.
Using all 3 types of knowledge rules gives pathogens that:
• are present and survive in end product;
• are likely to cause health problems in practice;
• are able to grow in end product.
Exposure assessment
For the exposure assessment, kinetics are assessed for
(re)contamination, growth, inactivation, contamination and
process models.
Outcome = log increase or log decrease in the different stages
(=characteristic number).
These characteristics describe the phenomena in a certain process → determine risk ranking.
Hazard characterisation
Hazard characterisation is the probability and severity of the disease: Pill(organism) = dose-response
relationships.
Risk characterisation
Risk characterisation is the probability/severity by consuming a certain amount of products, including
variability and uncertainty.
• Variability = “natural” variation → reduce by better control.
• Uncertainty = lack of knowledge → reduce by more research.
Severity has many different dimensions, sometimes a ranking of effects is necessary as well.
Examples of risk assessment
• Monte Carlo simulation → log probability of illness.
• FSO (=food safety objective1) concept.
1
Norm set by government.
3
, © 2024 J. de Jong
In the FSO concept, every partner in the chain can use the same concept.
• Appropriate Level of Protection illnesses/year (ALOP) = the level of protection deemed
appropriate by the Member (country) establishing a sanitary or phytosanitary measure to
protect human, animal or plant life or health within its territory→ D/R, consumption, ethics,
“distribution” of product groups.
• Food Safety Objective (FSO) = the maximum frequency and/or concentration of a (microbial)
hazard in a food at the time of consumption that still provides the ALOP (cfu/g or prevalence
(%) at consumption) → “distribution” over the chain.
• Performance Objective (PO) = the maximum frequency and/or concentration of a (microbial)
hazard in a food at a specified step in the food chain before time of consumption that still
provides or contributes to the achievement of an FSO or ALOP, as applicable (cfu/g or
prevalence (%)) → “distribution” over phenomena (initial contamination, growth,
inactivation, recontamination).
• Performance Criterion (PC) = the effect of one or more control measure(s) needed to meet or
contribute to meeting a PO → >6D inactivation, <3 logs growth → quantitative microbiology,
experiments, literature.
o Process criterion 15s 71.5°C
o Product criterion pH<4.6
A Performance Objective is equivalent to a FSO, specifying hazard levels that are tolerable, but are
set at one or more specific steps earlier in the food chain.
Toxicological and microbiological RA
Similarities
• General concepts (RA=RA+RM+RC; RA=HI+EA+HC+RC).
• More and more towards probabilistic approaches.
Differences
4
Food Safety Risk Assessment (FHM30306)
This summary was written in the academic year 2023-2024, including notes from all lectures
(+slides), background material from previous courses (+2 factsheets) and information from the PC
tutorials.
Contents
Food Safety Risk Assessment (FHM30306) ............................................................................................. 1
Lecture 1: microbiological risk assessment ............................................................................................. 2
Lecture 2: toxicological risk assessment ................................................................................................. 5
Lecture 3: packaging materials ............................................................................................................. 10
Lecture 4: heating of food products...................................................................................................... 12
Lecture 5: gut microbiome and toxicological risks ................................................................................ 14
Lecture 6: mycotoxins ........................................................................................................................... 16
Lecture 7: phytoestrogens .................................................................................................................... 21
Lecture 8: gram-positive pathogens ..................................................................................................... 23
Lecture 9: dose-response models ......................................................................................................... 27
Lecture 10: organic farming .................................................................................................................. 29
Lecture 11: labelling .............................................................................................................................. 31
Lecture 12: tools for microbial risk assessment .................................................................................... 33
Factsheet pathogenic bacteria .............................................................................................................. 39
Cheat sheet definitions ......................................................................................................................... 40
1
, © 2024 J. de Jong
Lecture 1: microbiological risk assessment
Food safety has a major impact on public health and the economy (recalls, lawsuits). It can never
totally be prevented, but it can be reduced. Quantitative objectives are set to control food safety
issues. There is a shared responsibility in society to minimise risk; safety depends on the weakest link
in the food supply chain.
Risk assessment is part of a larger risk analysis.
• Hazard = a biological, chemical or physical agent in food, or condition of food, with the
potential to cause an adverse health effect → potential to cause a risk.
• Risk = a function of the probability of an adverse health effect and the severity of that effect,
consequential to a hazard(s) in food → risk = severity x probability.
Risk analysis
Risk analysis = management concept. Contains:
• Risk assessment = a scientifically based process consisting of
hazard identification, hazard characterization, exposure
assessment and risk characterization. → by scientists.
• Risk management = weighing policy alternatives in the light of
the results of risk assessment, selecting and implementing
appropriate control options → by government, companies,
international trade.
• Risk communication = the interactive exchange of information and opinions throughout the
risk analysis process concerning risk, risk-related factors and risk perceptions, among →
consumers, scientists, risk managers, companies.
Not all levels of all hazards are unsafe → susceptible people require lower dose than healthy adults.
Risk assessment
Risk assessment = characterizing the potential adverse effects to
life and health resulting from exposure to hazards over a specified
time period.
Four steps
1. Which hazards and where? = hazard identification
2. Dose? Illness? = hazard characterisation
3. How many bacteria? = exposure assessment
4. Probability/burden? = risk characterisation
2
, © 2024 J. de Jong
Hazard identification
A good objective procedure is necessary for hazard identification
→ all pathogens; not just expected pathogens. Filtering may be
done by setting certain parameters to reduce the list.
• Rough HI: expected pathogen.
• Detailed HI: X different microorganisms.
Well defined qualitative rules:
1. survival rules: if pasteurisation → remove vegetative organisms.
2. general rules: remove exotic pathogens.
3. cardinal parameters: remove non-growers.
Using all 3 types of knowledge rules gives pathogens that:
• are present and survive in end product;
• are likely to cause health problems in practice;
• are able to grow in end product.
Exposure assessment
For the exposure assessment, kinetics are assessed for
(re)contamination, growth, inactivation, contamination and
process models.
Outcome = log increase or log decrease in the different stages
(=characteristic number).
These characteristics describe the phenomena in a certain process → determine risk ranking.
Hazard characterisation
Hazard characterisation is the probability and severity of the disease: Pill(organism) = dose-response
relationships.
Risk characterisation
Risk characterisation is the probability/severity by consuming a certain amount of products, including
variability and uncertainty.
• Variability = “natural” variation → reduce by better control.
• Uncertainty = lack of knowledge → reduce by more research.
Severity has many different dimensions, sometimes a ranking of effects is necessary as well.
Examples of risk assessment
• Monte Carlo simulation → log probability of illness.
• FSO (=food safety objective1) concept.
1
Norm set by government.
3
, © 2024 J. de Jong
In the FSO concept, every partner in the chain can use the same concept.
• Appropriate Level of Protection illnesses/year (ALOP) = the level of protection deemed
appropriate by the Member (country) establishing a sanitary or phytosanitary measure to
protect human, animal or plant life or health within its territory→ D/R, consumption, ethics,
“distribution” of product groups.
• Food Safety Objective (FSO) = the maximum frequency and/or concentration of a (microbial)
hazard in a food at the time of consumption that still provides the ALOP (cfu/g or prevalence
(%) at consumption) → “distribution” over the chain.
• Performance Objective (PO) = the maximum frequency and/or concentration of a (microbial)
hazard in a food at a specified step in the food chain before time of consumption that still
provides or contributes to the achievement of an FSO or ALOP, as applicable (cfu/g or
prevalence (%)) → “distribution” over phenomena (initial contamination, growth,
inactivation, recontamination).
• Performance Criterion (PC) = the effect of one or more control measure(s) needed to meet or
contribute to meeting a PO → >6D inactivation, <3 logs growth → quantitative microbiology,
experiments, literature.
o Process criterion 15s 71.5°C
o Product criterion pH<4.6
A Performance Objective is equivalent to a FSO, specifying hazard levels that are tolerable, but are
set at one or more specific steps earlier in the food chain.
Toxicological and microbiological RA
Similarities
• General concepts (RA=RA+RM+RC; RA=HI+EA+HC+RC).
• More and more towards probabilistic approaches.
Differences
4
