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Risk Management

It has long been recognised that the management of food safety could be improved by including a risk analysis approach. This uses a science-based analysis of food safety factors and tying the system to public health outcomes.

Risk analysis is established in the Codex Alimentarius and has passed into the EU General Food Law Regulation.

In the US in the more recent Food Safety and Modernization Act (FSMA) requires certain food processing businesses to implement an HACCP system with risk analysis, which the FDA calls Hazard Analysis and Risk-Based Preventive Controls (HARPC).

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Codex Alimentarius approach

The objective of applying risk analysis to food safety is the protection of human health.

Codex Alimentarius is a set of standards, guidelines and codes of practice to monitor and manage food safety. It recommends that it is established as an integral part of national food safety systems. Risk analysis should be:

  • applied consistently;
  • open, transparent and documented; and
  • evaluated and reviewed as appropriate in the light of newly generated scientific data.

Risk-analysis methods for food safety have been developed jointly by WHO and FAO and implemented in the Codex Alimentarius for many years. These are used as the basis for food safety standards by food standards bodies.

Three staged structured approach to risk analysis:

1. Risk assessment

The scientific evaluation of known or potential adverse health effects from exposure to foodborne hazards using the following steps:

  • Hazard identification: the identification of known or potential health effects associated with a particular agent.
  • Hazard characterization: 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.
  • Exposure assessment: qualitative and/or quantitative evaluation of the degree of intake likely to occur.
  • Risk characterization: integration of the previous steps into an estimation of the adverse effects likely to occur in a given population, including attendant uncertainties. It includes quantitative and qualitative assessment, as well as an indication of the attendant uncertainties.

2. Risk management

Risk management follows a structured approach to determine and implement the appropriate options. It consists of four components:

  • Preliminary risk management activities. The establishment of a risk profile to provide as much information as possible to guide further action.
  • Evaluation of risk management options. This involves assessing the options for managing a food safety issue taking account of scientific information on risks and other factors. Optimization of the efficiency, effectiveness, technological feasibility and practicality of food control measures at selected points throughout the food-chain is an important goal.
  • Implementation of the risk management decisions. Implementation involves regulatory food safety measures, such as the use of an HACCP system. It is essential to continuously verify the application of food safety measures.
  • Monitoring and review. This consists of gathering and analyzing data to give an overview of food safety and consumer health. Monitoring should identify new food safety problems as they emerge and indicate where redesign of food safety measures is needed to achieve the required public health goals.

3. Risk communication

Communication is an integral part of the risk analysis and all stakeholder groups should be involved from the start to exchange information and opinion and ensure the process, outcomes, significance and limitations are understood.

Stakeholders include risk assessors, risk managers, and other interested parties.

The identification of interest groups and their representatives should comprise a part of an overall risk communication strategy.

  • When the risk analysis process has identified the hazards and decided on and assessed the appropriate risks, then this information should be prepared and disseminated to stakeholders.
  • This will be followed by further discussions with stakeholders, to identify corrections, amendments, and additions as appropriate, and then produce the final risk assessment and risk analysis reports.


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