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3. RISK ANALYSIS DEFINITIONS

3.1 Context of definitions

The 41st Session of CAC Executive Committee clearly identified the need for uniform definitions for various risk analysis terms. The Consultation considered definitions adopted or proposed by various bodies, including Codex, other international organisations and national bodies. The Consultation considered the definition of "risk assessment" given in the SPS Agreement and noted that the definition was broader in scope than, but not inconsistent with, the definition developed by the Consultation.

These definitions relate to food safety as influenced by foodborne agents. For the purposes of the Consultation, foodborne agents were considered to be chemical, biological and physical agents in or on food whether added intentionally or through natural processes. However, these definitions do not take into account live animals, food itself or the natural components of food when present within normal limits.

3.2 Definitions of risk analysis terms related to food safety

FOOD:

Any substance, whether processed, semi-processed or raw which is intended for human consumption, including drinks, chewing gum and any substance which has been used in the manufacture, preparation or treatment of "food" but excluding cosmetics, tobacco and substances used only as drugs.

HAZARD:

A biological, chemical, or physical agent in or property of food that may have an adverse health effect.

RISK:

A function of the probability of an adverse effect and the magnitude of that effect, consequential to a hazard(s) in food.

RISK ANALYSIS:

A process consisting of three components: risk assessment, risk management and risk communication.

RISK ASSESSMENT:

The scientific evaluation of known or potential adverse health effects resulting from human exposure to foodborne hazards. The process consists of the following steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization. The definition includes quantitative risk assessment, which emphasizes reliance on numerical expressions of risk, and also qualitative expressions of risk, as well as an indication of the attendant uncertainties.

HAZARD
IDENTIFICATION:

The identification of known or potential health effects associated  with a particular agent.

HAZARD
CHARACTERIZATION:

The qualitative and/or quantitative evaluation of the nature of the adverse 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 or physical agents, a dose-response assessment should be performed if the data is obtainable.

EXPOSURE
ASSESSMENT:

The qualitative and/or quantitative evaluation of the degree of  intake likely to occur.

RISK
CHARACTERIZATION:

Integration of hazard identification, hazard characterization and exposure assessment into an estimation of the adverse effects likely to occur in a given population, including attendant uncertainties.

RISK MANAGEMENT:

The process of weighing policy alternatives to accept, minimize or reduce assessed risks and to select and implement appropriate options.

RISK
COMMUNICATION:

An interactive process of exchange of information and opinion on risk among risk assessors, risk managers, and other interested parties.

DOSE-RESPONSE
ASSESSMENT:

The determination of the relationship between the magnitude of  exposure and the magnitude and/or frequency of adverse effects.

SCENARIO SET:

A construct characterizing the range of likely pathways affecting the safety of the food product. This may include consideration of processing, inspection, storage, distribution and consumer practices. Probability and severity values are applied to each scenario.


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