Training Workshop: Food recall and traceability - Application in National food safety control 15 -17 February 2013, Chiang Mai , Thailand “Principles for Risk Analysis for Food Safety for Application by Governments” Patrick Deboyser Advisor - Health & Consumers DG, European Commission Professor - European College of Parma
Principles of Risk Analysis for Food Safety Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand
Principles of Risk Analysis for Food Safety Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand
Principles of Risk Analysis for Food Safety Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand ► Risk Analysis: Definitions ■ 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.
Principles of Risk Analysis for Food Safety Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand ► Structure of Risk Analysis Risk assessment Risk Management Risk Communication
Principles of Risk Analysis for Food Safety Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand ► Risk Analysis: general aspects (1) ■ Objective - to ensure human health protection . ■ Characteristics - Risk analysis should be: o applied consistently and in a non discriminatory manner to issues of national food control and food trade; o open, transparent and documented; and o evaluated and reviewed as appropriate in the light of newly generated scientific data. ■ Functional separation - There should a functional separation of risk assessment and risk management to the degree practicable, in order to: o ensure the scientific integrity of the risk assessment, o to avoid confusion over the functions to be performed by risk assessors and risk managers and o to reduce any conflict of interest. ■ Precaution - is an inherent element of risk analysis.
Principles of Risk Analysis for Food Safety Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand ► Risk Analysis: general aspects (2) ■ Guidance : National governments should take into account relevant guidance and information obtained from risk analysis activities pertaining to human health protection conducted by Codex, FAO, WHO and other relevant international intergovernmental organizations, including OIE and IPPC. ■ Training/capacity building : With the support of international organizations where appropriate, national governments should design and/or apply appropriate training, information and capacity building programs that are aimed to achieve the effective application of risk analysis principles and techniques in their food control systems. ■ Exchanges: National governments should share information and experiences on risk analysis with relevant international organisations, other national governments (e.g. at the regional level through FAO/WHO Regional Coordinating Committees) to promote and facilitate a broader and, where appropriate, more consistent, application of risk analysis.
Principles of Risk Analysis for Food Safety Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand ► Risk Assessment: definition/structure A scientifically based process consisting of the following steps: ■ 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 and physical agents which may be present in food; ■ exposure assessment - the 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 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.
Principles of Risk Analysis for Food Safety Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand ► Risk Assessment: independance ■ Functional separation from risk management ■ Independence of experts Conflict of interests Experts involved in risk asessment including government officials and experts from outside government should be objective in their scientific work and not be subject to any conflict of interest that may compromise the integrity of the assessment. Identity Information on the identities of these experts, their individual expertise and their professional experience should be publicly available, subject to national considerations. Selection These experts should be selected in a transparent manner on the basis of their expertise and their independence with regard to the interests involved, including disclosure of conflicts of interest in connection with risk assessment.
Principles of Risk Analysis for Food Safety Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand ► Risk Management: definition The process, distinct from risk assessment, ■ of weighing policy alternatives in consultation with all interested parties considering o risk assessment and o 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.
Principles of Risk Analysis for Food Safety Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand ► Risk Management: structure Risk management should follow a structured approach including: ■ risk management activities, ■ evaluation of risk management options, ■ implementation, and ■ review of the decision taken ► Risk Management: objectives Primary objective = the protection of the health of consumers
Principles of Risk Analysis for Food Safety Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand ► Risk Management: decisions Decisions should be: ■ based on risk assessment, taking into account, where appropriate, other legitimate factors relevant: o for the health protection of consumers and o for the promotion of fair practices in food trade ■ based on Codex standards and related texts, where available.
Principles of Risk Analysis for Food Safety Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand ► Risk Communication: definition The interactive exchange of information and opinions throughout the risk analysis process: ■ Concerning: risk, risk-related factors, and risk perceptions; ■ Among: risk 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.
Principles of Risk Analysis for Food Safety Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand ► Structure of Risk Analysis Risk assessment Risk Management • Hazard assessment • Risk evaluation • Hazard characterization • Assessment of options • Exposure assessment • Implementation • Risk characterisation • Monitoring and evaluation Risk Communication
Principles of Risk Analysis for Food Safety Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand How is the EU implementing these principles? ► Regulation (EC) No 178/2002 ► Objectives ► Functional separation (risk assessment > risk management) ► Risk assessment: independence of staff and experts ► Risk management: ■ Based on: international standards (Codex) risk assessment (science) ■ Other legitimate factors ■ Precautionary principle ► Direct application
Principles of Risk Analysis for Food Safety Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand ► Regulation (EC) 178/2002 ■ General principles of food law Objectives Definitions Principles of risk analysis Principles of international food trade Principle of traceability Responsibilities ■ Creation of European Food Safety Authority (EFSA) ■ Procedures Rapid Alert System for Food and Feed Crisis management Urgent procedures
Principles of Risk Analysis for Food Safety Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand ► Objectives Food law shall pursue one or more of the general objectives of: ■ a high level of protection of human life and health, and ■ the protection of consumers' interests, including fair practices in food trade; taking account of, where appropriate, the protection of: ■ animal health ■ animal welfare, ■ plant health, and ■ the environment. Food law shall aim to achieve the free movement of food and feed in the European Union.
Principles of Risk Analysis for Food Safety Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand ► Functional separation ■ Before 2000. ■ Regulation 178/2002 Risk assessment: EFSA (European Food Safety Authority) National agencies of EU Member States Risk management: European Commission – EU Parlement – EU Council EU Member States
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