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III. Agreement on the Application of Sanitary and
Phytosanitary Measures (SPS) and Agreement
on Technical Barriers to Trade (TBT)



Risk Analysis and Codex

Food Quality and Standards Service
Food and Nutrition Division


This module provides the reader with an overview of the elements of the risk analysis process and the progress being made towards the development of a harmonized approach to risk analysis at the international level. This includes discussion on the assessment of risks due to hazards associated with foods; the principles of risk management; and the communications necessary to keep those involved well informed. The requirements of the WTO Agreement as it relates to food risk and the important steps taken by Codex are described.


10.1 Introduction

10.2 Risk analysis

10.3 Risk assessment

10.4 Risk management

10.5 Risk communication

10.6 Risk analysis and Codex

Annex 1: Definition of risk analysis terms related to food safety for the purposes of the Codex Alimentarius

Annex 2: Statements of principle relating to the role of food safety risk assessment - Appendix to the procedural manual on the Codex Alimentarius Commission



The elements of risk analysis

For the purpose of this module, we focus on risks related to the hazards associated with food for human consumption. Risk analysis has been used in one form or another for centuries. Every time someone makes a deliberate decision not to eat a food because it appears suspicious, it involves an assessment process that analyses the situation, resulting in an evaluation of what the consequences may be to eat that food. The decision is based on the perception of the degree of risk associated with the food, which depends on the information available at the time. Perhaps the appearance of the food was abnormal, or it had an unusual odour, or it tasted "bad". A simple form of risk assessment based on the sensory observations was the first step. The decision not to eat the food on the basis that it may cause sickness is risk management. When others are informed of your assessment and the decision, you have communicated a risk information message that prevents others from possible illness. In this manner, you have completed what experts in the field of Risk Analysis consider to be the three primary elements of Risk Analysis, that is Risk Assessment, Risk Management and Risk Communication

This technique was undoubtedly used by our ancestors and found to be effective in avoiding risk. In today's world however, where potential hazards to our food supply come from a variety of sources, many of which cannot be detected by simple observation, it no longer serves us so well. The food supply of today is subject to hazards that did not exist in the past, and derive from sources all along the food chain. In addition, the effects on the consumer of many of today's hazards are significantly greater than in the past. However, some biological and physical hazards of the past are still with us today and are just as severe in their effect now as they were in the past.

Food law, regulations, and standards were introduced by governments in order to protect consumers by official means. The introduction of these measures was facilitated by the development and continued refinement of the scientific disciplines needed to identify, detect and confirm the presence of hazards in food and their sources. Major advances in the life sciences (chemistry, biology, microbiology, and biochemistry) in the early to mid 1800s gave us a greater understanding of the hazards and their ill effects on human health and the need for consumer protection. Without suitable controls, there could be serious health consequences for most of the population.

Risks vs. hazards

Risk analysis is the systematic evaluation of the risks arising from hazards in food. It is a process, which comprises the assessment, management and communication of risk and normally results in a clear statement as to whether an attribute of the food is hazardous and to what degree it represents a food safety risk. For some people the terms "Risk" and "Hazard" are interchangeable. In actual fact, the two terms have quite different meanings.

The generally accepted definition for the term "HAZARD" is a biological, chemical, or physical agent in, or condition of, food with the potential to cause an adverse health effect. It can be an agent of biological origin (such as pathogenic bacteria, viruses, parasites, or other organisms) or the product of these organisms with properties which can harm human health. It can also be a chemical substance in or on the food from external sources such as industrial pollution, agricultural inputs of fertilizers or pesticides, or substances added to food intentionally or by accident in excess of safe levels. It may also be a physical material, such as a stone in dried rice, a piece of bone in ground meat, a cherry or olive seed, or a piece of glass or metal in food resulting from a mishap during food manufacturing or processing, which may cause injury when biting down or if swallowed.

Any human health risk associated with food is directly related to the hazards present in or on the food when consumed. In some cases, the food itself may pose certain risks to some portion of the general population. The illness or injury caused by a hazard can range from minimal to extremely severe and life threatening. The severity of the illness or injury may be proportional to the quantity of the hazardous food or substance consumed immediately or accumulating over time. Consequently, the nature and character of the hazard and the level, frequency and duration of exposure are important factors. A full range of scenarios would be needed to describe the impact of the various types of food hazards and the risks they pose to human health. Hazardous agents associated with food should be well understood so that risks can be appropriately estimated and acceptable (safe) levels of risk can be established for the protection of consumers.

The term "RISK" can be defined as a function of the probability of an adverse effect and the severity of that effect, consequential to a hazard(s) in food. Risk is usually expressed as a ratio. It is an estimate of the chances you may have of being affected by the hazard in question, given that an appropriate assessment of the hazard was made and uncertainties were factored in. For example, the risk of contracting cancer from exposure to a cancer causing chemical agent in the environment due to industrial pollution, might be that one person in a million will actually contract the disease. So, in a country with 10 million people, 10 persons would be expected to contract cancer from that particular chemical pollutant each year. Therefore, your risk of contracting cancer from this substance can be expressed as one in a million.


Risk analysis now a key element in food trade rules...

In March 1991, a Joint FAO/WHO Conference on Food Standards, Chemicals in Foods and Food Trade was convened in Rome, Italy. Nearly 400 participants from 78 countries with observers from 28 different international organizations attended this Conference. The Conference recognized the importance of the joint FAO/WHO scientific advisory committees such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) in providing evaluations based on sound science and risk assessment principles and recommended that WHO and FAO take steps to increase awareness of these principles. The Conference also recommended that the Codex Alimentarius Commission (CAC) and the relevant Codex committees responsible for the development of standards, codes of practice or guidelines concerned with the protection of human health should make explicit the methods they have used to assess risk assessment determinations.

In 1995, with the coming into effect of the SPS Agreement, Members of the WTO reaffirmed their right through this Agreement to adopt and enforce measures necessary to protect human, animal or plant life or health. The measures are subject to the requirement that they are not applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between Members where the same conditions prevail or as a disguised restriction on international trade. Sanitary and phytosanitary measures are to be based on scientific principles. Justification is to be through sound scientific evidence and risk analysis procedures developed for international use by the relevant organizations whenever the appropriate level of protection required by the Member is higher than the level established by the international food standards, guidelines and recommendations of the Codex Alimentarius Commission.

The appropriate level of sanitary and phytosanitary protection is defined in the Agreement as "the level of protection deemed appropriate by the Member establishing a sanitary and phytosanitary measure to protect human, animal or plant life or health within a territory". Many Members otherwise refer to this concept as the "acceptable level of risk". Compliance with Codex standards is recognized as providing the appropriate level of protection.

...but no recognized procedures existed when SPS Agreement was signed

If Members of the WTO do not use the internationally recognized standards they must ensure that their sanitary and phytosanitary measures are based on an assessment, as appropriate to the circumstances, of the risks to human, animal or plant life or health taking into account the risk assessment techniques developed by the Codex Alimentarius Commission. In the assessment of risks, members are to take into account the available scientific evidence, relevant processes and production methods, and relevant sampling and testing methods.


At the request of the CAC, the Joint FAO/WHO Expert Consultation on the Application of Risk Analysis to Food Standard Issues was held in March 1995 to provide scientific advice on this specific issue. The objective of the consultation was to provide recommendations on the most appropriate approaches to the application of risk analysis and risk management to food standards issues.

Risk assessment model discussed in 1995 FAO/WHO Consultation

The Consultation agreed on a series of definitions of terms and on a model for risk assessment that were submitted to the CAC for consideration. It agreed that the risk analysis process consisted of three primary elements, namely, risk assessment, risk management and risk communication. It also described the risk assessment process as "the scientific evaluation of known and potential adverse effects resulting from human exposure to foodborne hazards".

The four steps of the risk assessment process are outlined below:

Hazard Identification. The identification of known and potential health effects associated with a particular agent.

Hazard Characterization. A qualitative and/or quantitative evaluation of the nature of the adverse effects associated with biological, chemical and physical agents that 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 are 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.

A copy of this consultation report is available and it should be reviewed for a more detailed description of the risk assessment process.

Risk assessment at the international level discussed in 1999 FAO/WHO Consultation

A further Joint FAO/WHO Expert Consultation on Risk Assessment of Microbiological Hazards in Foods was held in Geneva in March 1999. This consultation addressed the issue of carrying out a microbiological food safety risk assessment. It recognized that the "Principles and Guidelines for the Conduct of Microbiological Risk Assessment" developed by the Codex Committee on Food Hygiene and adopted by the 23rd Session of the CAC provide a framework for the conduct of microbiological risk assessment at an international level. The consultation recommended that FAO and WHO provide a vehicle for expert advice in this area. The full report of this consultation has been published and is also available on the Internet.


Risk management discussed in 1997 FAO/WHO Consultation

In January of 1997, a second Joint FAO/WHO Consultation on Risk Management and Food Safety was convened in Rome. This consultation reviewed current risk management practices in the framework of Codex and the expert committees, proposed definitions, identified the elements of risk management and defined general principles of risk management for food.

It identified risk management as a major element in the risk analysis process and defined it as the process of weighing policy alternatives in the light of the results of risk assessment and, if required, selecting and implementing appropriate control options, including regulatory measures.

The consultation identified four major elements of risk management as follows:

The risk evaluation process consists of the identification of the food safety problem, and the establishment of a risk profile. This involves describing a food safety problem and its context in order to identify those elements of the hazard or risk relevant to the various risk management decisions. The risk profile should include the identification of aspects of hazards relevant to prioritizing and setting the risk assessment policy and aspects of the risk relevant to the choice of safety standards and management options. A typical risk profile might include a brief description of the situation, product and commodity involved, the values expected to be placed at risk (human health, economic concerns), potential consequences, consumer perceptions of the risk, and a distribution of the risks and benefits.

Risk evaluation also includes ranking of the hazard for risk assessment and risk management priority and the establishment of risk assessment policy for the conduct of risk assessment. Risk assessment policy would include such activities as establishing the populations that may be at risk in relation to specific hazards in food, establishing the criteria for ranking of hazards, and preparing guidelines for the application of safety factors.

Finally, risk evaluation also includes commissioning of a risk assessment and the consideration of risk assessment results.

Related to the risk management options assessment, the steps include the identification of the available management options, selection of preferred management options, including consideration of an appropriate safety standard (acceptable level of risk) and the final management decision.

Following the implementation of the management decision, there remains the process of monitoring and reviewing to assess the effectiveness of the measures taken, and a review of the risk management and/or assessment as necessary.

This consultation also identified eight basic principles to the food safety risk management process.

Principle 1 Risk management should follow a structured approach.

Principle 2 Protection of human health should be the primary consideration in risk management decisions.

Principle 3 Risk management decisions and practices should be transparent.

Principle 4 Determination of risk assessment policy should be included as a specific component of risk management.

Principle 5 Risk management should ensure the scientific integrity of the risk assessment process by maintaining the functional separation of risk management and risk assessment.

Principle 6 Risk management decisions should take into account the uncertainty in the output of the risk assessment.

Principle 7 Risk management should include clear, interactive communication with consumers and other interested parties in all aspects of the process.

Principle 8 Risk management should be a continuing process that takes into account all newly generated data in the evaluation and review of risk management decisions.

A copy of the report and all recommendations coming from this consultation is available and should be reviewed in light of the process identified in the risk management element.


Principles of risk communication discussed in 1998 FAO/WHO Consultation

To complete the advisory process on risk analysis, a third Joint FAO/WHO Consultation was held on the Application of Risk Communication to Food Standards and Safety Matters in February 1998. This consultation identified the elements and guiding principles of risk communication, barriers to effective risk communication and strategies for effective risk communication.

The consultation identified the following principles for effective risk communications.

Know the audience. Understanding the motivation, opinions, concerns and feelings of the individuals and groups that make up the audience and designing risk communication messages to address these issues improve communications. Listening to all interested parties is an important aspect of risk communication.

Involve the scientific experts. These experts should be involved to the extent that they can provide information on the risk assessment process and the results, including the assumptions and subjective judgement, so that risk managers have complete information and understanding of the risk.

Establish expertise in communication. Communication expertise is important to the conveyance of the appropriate risk message in a manner that is clear, understandable and informative. Experts in this field should be involved in the process of communication from the very start.

Be a credible source of information. Information from a credible source is more likely to be accepted by the public. Consistent messages received from multiple sources lend credibility to the risk message. To be credible the public must recognize competence, trustworthiness, fairness and lack of bias. In addition, the communications specialist must be factual, knowledgeable, expert, aware of the public welfare, responsible, and truthful and have a good track record. Effective communications acknowledge current issues and problems, are open in their content and approach, and are timely.

Share responsibility. There are multiple players in the communication process, including regulatory officials, industry, consumers and the media. Each has a specific role to play and by sharing this responsibility, each can do their part to assure effective communications.

Differentiate between science and value judgement. It is essential to separate fact from values in considering development of a risk communication message.

Assure transparency. To ensure public acceptance of risk messages, the process must be open and available for scrutiny by interested parties.

Put the risk in perspective. By examining the risk in terms of the benefits and by comparing with other more familiar risks the risk can be put in perspective. However this must not be done in a manner that may be construed by the public as using a comparison to diminish the importance of the risk issue at hand.

Again, a copy of the complete report is available and should be reviewed before embarking on a risk communication problem.


At the 20th Session of the CAC, Geneva in 1993, the CAC examined the risk assessment procedures used by the Commission and its subsidiary and advisory bodies. The CAC recommended that the Codex Committee on General Principles should address the adoption of risk analysis, including the possibility of changes in the Codex Rules of Procedure and in the terms of reference of the relevant Codex Committees.

Introducing risk analysis into Codex

Since its 20th Session, the Codex Alimentarius Commission has been considering matters regarding risk analysis in Codex. Risk analysis is considered to be an integral part of the decision-making process of Codex. The 42nd Session of the Codex Executive Committee (CEC), June 1995, considered the report of the Joint FAO/WHO Expert Consultation on the Application of Risk Analysis to Food Standards Issues, Geneva, March 1995. The CEC addressed the issues on risk assessment of chemical and biological agents in food and the problems related to uncertainty and variability in risk analysis. Subsequent to the Consultation, FAO and WHO suggested a number of minor modifications to the definitions proposed by the Consultation, based on existing definitions in the wider risk analysis context.

The 21st Session of the CAC, July 1995, endorsed the recommendations of the Consultation in principle, especially in regard to the importance of further work on the review of methodology and guidelines currently used for predicting dietary intake, particularly on a regional basis. It noted that there was a need for further clarification of the terms and definitions used for risk analysis. The Commission also recommended further work to address risk management and risk communication and in defining the roles and responsibilities of the different bodies involved in the risk analysis process as well as on uncertainty and variability in risk analysis in relation to standard setting and food regulation. The CAC agreed that relevant Codex committees, especially the Committee on General Principles, should examine the report and recommendations of the Consultation so that the risk analysis concept would be incorporated into the Codex procedures and in the list of terms and definitions for Codex purposes.

Risk analysis definitions adopted

At the 22nd Session of the CAC, the Commission adopted definitions of risk analysis terms related to food safety (Annex 1). The definitions of risk communication and risk management were later modified at the 23rd session of the CAC. The CAC also adopted Statements of Principle Relating to the Role of Food Safety Risk Assessment (Annex 2). A paper had been prepared with an objective to develop an action plan to be used by Codex in applying risk analysis more consistently and uniformly with a particular emphasis on risk management. The paper included the recommendations made by the Joint FAO/WHO Expert Consultation on Risk Management and Food Safety for consideration by the Commission.

Action plan to develop risk analysis principles

The Commission considered the recommendations of the Joint FAO/WHO Consultation on Risk Management and Food Safety and agreed on an action plan for Codex-wide development and application of risk analysis principles. In this respect the Commission agreed to the following:

The Commission agreed that the Codex Working Principles for Risk Analysis would be elaborated through the step-wise procedure, with the possibility of omission of steps, should the Committee on General Principles so recommend.

Codex risk analysis work programme

The 23rd Session of the Commission (June/July 1999) adopted the following recommendations to be applied in the framework of Codex:

Recommend-ations to governments

The Commission also endorsed the following recommendations addressed to governments:

Recommend-ations to FAO/WHO

The Commission addressed the following recommendations to FAO and WHO:



FAO. 1999. The application of risk communication to food standards and safety matters. Food and Nutrition Paper 70. Rome.

FAO. 1999. Report of the FAO Expert Consultation on the Trade Impact of Listeria in Fish Products (Amherst, MA, USA) FAO Fisheries Report No. 604. Rome.

FAO. 1999. International Food Trade Beyond 2000; Science-based decisions, harmonization, equivalence and mutual recognition. Report of the meeting, 11-15 October 1999 - Melbourne, Australia. Rome.

FAO. 1997. Risk management and food safety. Report of a Joint FAO/WHO Consultation. Food and Nutrition Paper 65. Rome.

FAO. 1991. FAO/WHO Conference on Food Standards, Chemicals in Food and Food Trade. Rome, 18-27 March 1991. Vol 1-Report. Rome.

WHO. 1999. Risk assessment of microbiological hazards in foods. Report of a Joint FAO/WHO Expert Consultation, Geneva, Switzerland, 15-19 March. Geneva.

WHO. 1997. Food consumption and exposure assessment of chemicals. Report of a FAO/WHO Consultation, Geneva, Switzerland. Geneva.

WHO. 1995. Application of risk analysis to food standards issues. Report of a Joint FAO/WHO Expert Consultation, Geneva, Switzerland, 13-17 March. Geneva.


Annex 1


HAZARD: A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect.

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

RISK ASSESSMENT: A scientifically based process consisting of the following steps: (1) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization.

HAZARD IDENTIFICATION: The 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 CHARACTERIZATION: The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with biological, chemical or physical agents that 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 are obtainable.

DOSE-RESPONSE ASSESSMENT: The determination of the relationship between the magnitude of exposure (dose) to a chemical, biological or physical agent and the severity and/or frequency of associated adverse health effects (response).

EXPOSURE ASSESSMENT: The qualitative and/or quantitative evaluation of the likely intake of biological, chemical and physical agents via food as well as exposure from other sources if relevant.

RISK CHARACTERIZATION: The 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.

RISK MANAGEMENT3: The process, distinct from risk assessment, of weighing policy alternatives in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options.

RISK COMMUNICATION4: The interactive exchange of information and opinions throughout the risk analysis process concerning risk-related factors and risk perceptions, among assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions.


Annex 2



1) Health and safety aspects of Codex decisions and recommendations should be based on a risk assessment, as appropriate to the circumstances.

2) Food safety risk assessment should be soundly based on science, should incorporate the four steps of the risk assessment process, and should be documented in a transparent manner.

3) There should be a functional separation of risk assessment and risk management, while recognizing that some interactions are necessary for a pragmatic approach.

4) Risk assessments should use available quantitative information to the greatest extent possible and risk characterization should be presented in a readily understandable and useful form.


1 This would include requiring that Codex Committees involved in any aspect of risk analysis formally describe their implementation of the Codex principles and guidelines, using a standardized summary format, for publication in their respective reports and recommend that advisory bodies such as JECFA and JMPR do the same. It would also require that Codex Committees develop standards using these principles and guidelines as a checklist, and in doing so adhere closely to their documented risk assessment/risk management policies.

2 These definitions are proposed on an interim basis: they are subject to modification in the light of developments in the science of risk analysis and as a result of efforts to harmonize similar definitions across various disciplines.

Source: Report of the 22nd session of the Codex Alimentarius Commission, Geneva, 1997.

3 Source: Report of the 23rd session of the Codex Alimentarius Commission, Rome, 1999.

4 Source: Report of the 23rd session of the Codex Alimentarius Commission, Rome, 1999.

5 Source: Report of the 22nd session of the Codex Alimentarius Commission, Geneva, 1997.

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