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FAO/WHO CODEX TRAINING PACKAGE
SECTION FOURSCIENTIFIC BASIS FOR
CODEX WORK
Module 4.1Risk analysis
in the framework of Codex
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What is risk analysis?
A process consisting of three components: risk assessment,
risk management and risk communication.
It is a structured, systematic process that examines the potential
adverse health effect consequential to a hazard or condition of a
food and develops options for mitigating that risk.
It includes interactive communication among all interested parties
involved in the process.
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Why undertake risk analysis?
To identify methods to address food safety more effectively
To introduce appropriate food control measures
Risk analysis has become the cornerstone in developing food
control measures
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Difference between risk analysis and
hazard analysis
Hazard analysis - addresses hazards within a narrow context, such
as the potential for the hazard to enter a food at a plant/processing
level. A hazard analysis is usually conducted at the plant/process level
to establish a Hazard Analysis and Critical Control Point (HACCP)
plan.
Risk analysis - also deals with hazards, as well as the condition of a
food; however, it does so on a broader scale. This process examinesthe potential impact of a hazard that is introduced into the food supply,
taking into account exposure from other sources.
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Risk analysis and Codex
1991FAO/WHO Conference on Food Standards,
Chemicals in Foods and Food Trade Risk analysis is an integral part of the decision-making
process of Codex
Twenty-second Session of CAC FAO/WHO
Microbiological Risk Assessment Programme initiated
Codex principles and guidance on risk analysis for use
by Codex subsidiary bodies
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Definition of risk analysis terms
HazardA biological, chemical or physical agent in, or condition of,
food with the potential to cause an adverse health effect.
RiskA function of the probability of an adverse health effect and the
severity of that effect, consequential to a hazard(s) in food.
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Definition of risk analysis terms
(cont.)
Risk assessmentThe scientific evaluation of known or potential
adverse effects resulting from human exposure to food-borne
hazards. Risk assessment consists of four steps:
Hazard identification
Hazard characterization
Exposure assessment
Risk characterization
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Definition of risk analysis terms
(cont.)
Hazard ident if icationThe identification of biological, chemical
and physical agents capable of causing adverse health effects and
which may be present in a particular food or group of foods.
Hazard characterizationThe qualitative and/or quantitative
evaluation of the nature of the adverse health effects associated
with biological, chemical, and physical agents which may be
present in food. For chemical agents, a dose-response assessment
should be performed. For biological and physical agents, a dose-
response assessment should be performed if the data are available.
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Definition of risk analysis terms
(cont.)
Exposure assessmentThe qualitative and/or quantitative
evaluation of the likely intake of biological, chemical, and physical
agents via food as well as exposures from other sources if relevant.
Risk characterizationThe qualitative and/or quantitative
estimation, including attendant uncertainties, of the probability
of occurrence and severity of known or potential adverse health
effects in a given population based on hazard identification,hazard characterization and exposure assessment.
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Definition of risk analysis terms
(cont.)
Risk managementThe process, distinct from risk assessment, of
weighing policy alternatives, in consultation with all interested parties,
considering risk assessment and other factors relevant for the healthprotection of consumers and for the promotion of fair trade practices
and, if needed, selecting appropriate prevention and control options.
Risk communicationThe interactive exchange of information and
opinions throughout the risk analysis process concerning risks, risk-
related factors and risk perception, among risk assessors, riskmanagers, consumers, industry, the academic community and other
interested parties, including the explanation of risk assessment
findings and the basis of risk management decisions.
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Key components of
risk communication
Know the audience
Involve the scientific experts Establish expertise in communication
Be a credible source of information
Share responsibility
Differentiate between science and value judgement
Assure transparency and put the risk in perspective
An integral component of the risk analysis process
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Basic steps in risk analysis (cont.)
4. Risk management options to address the risk are identified.
5. The options are evaluated and a decision is made as to which
option is the most appropriate, including the option to take noaction.
6. The risk management option is implemented.
7. The decision is monitored and reviewed to verify that the selected
risk management option is effective.
8. Throughout the process, iterative communication among all
interested parties (risk assessors, risk managers, consumers,
industry, etc.) is implemented and maintained.
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CCPR determines a priority list of substances for evaluation
(hazard identification)
JMPR conducts its evaluation including a toxicological assessment
and establishes an ADI (hazard characterization/exposure
assessment)
Example of the risk analysis process
in the context of CCPR work
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Matching of MRLs with the ADI or acute RfD (risk characterization)
CCPR reviews JMPR report and recommends MRLs for adoption
by the Commission (evaluation of options and decision-making:
risk management)
Example of the risk analysis process in
the context of CCPR work (cont.)
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Principles of food safety
risk assessment
Principle 1:
Health and safety aspects of Codex decisions and
recommendations should be based on a risk assessment,
as appropriate to the circumstances.
Principle 2:
Food safety risk assessment should be soundly based onscience, should incorporate the four steps of the risk
assessment process and should be documented in a
transparent manner.
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Principles of Food Safety
Risk Assessment (cont.)
Principle 3:
There should be a functional separation of risk assessment
and risk management, while recognizing that some
interactions are essential for a pragmatic approach.
Principle 4:
Risk assessments should use available quantitative
information to the greatest extent possible, and risk
characterizations should be presented in a readily
understandable and useful form.
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Scientific basis
for risk analysis in Codex
FAO/WHO through expert meetings or ad hoc consultations
e.g. JECFA, JMPR, JEMRA