15 -17 February 2013, Chiang Mai , Thailand Principles for Risk - - PowerPoint PPT Presentation

Patrick Deboyser

Advisor - Health & Consumers DG, European Commission Professor - European College of Parma

“Principles for Risk Analysis for Food Safety for Application by Governments”

Training Workshop: Food recall and traceability - Application in National food safety control

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 Principles of Risk Analysis for Food Safety

Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand

Risk assessment

Risk Management Risk Communication

►Risk Analysis: general aspects (1)

■ Objective - to ensure human health protection. ■ Characteristics - Risk analysis should be:

• applied consistently and in a non discriminatory manner to issues of national

food control and food trade;

• open, transparent and documented; and
• 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:

• ensure the scientific integrity of the risk assessment,
• to avoid confusion over the functions to be performed by risk assessors and

risk managers and

• 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

• n 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
• 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.

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:

• for the health protection of consumers and
• 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 Principles of Risk Analysis for Food Safety

Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand

Risk assessment

• Hazard assessment
• Hazard characterization
• Exposure assessment
• Risk characterisation

Risk Management

• Risk evaluation
• Assessment of options
• Implementation
• Monitoring and evaluation

Risk Communication

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

Principles of Risk Analysis for Food Safety

Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand

► Independence of staff and experts

Management of conflicts of interests by EFSA:

• Screening of candidates before appointment
• Requiring detailed declaration of interest
• Monitoring the outsourcing of services
• Policing gifts and invitations
• Training staff
• Addressing post-employment situations
• Mobility of staff in sensitive functions.

Principles of Risk Analysis for Food Safety

Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand

► Risk management

■ Based on international standards

• Where international standards exist or their completion is imminent,

they shall be taken into consideration in the development or adaptation of food law

• Except:
• where such standards or relevant parts would be an ineffective or

inappropriate means for the fulfilment of the legitimate objectives

• f food law, or
• where there is a scientific justification, or
• where they would result in a different level of protection from the
• ne determined as appropriate in the EU.

Principles of Risk Analysis for Food Safety

Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand

► Risk management

■ Based on risk assessment (science)

• Risk management shall take into account the results of risk

assessment, and in particular, the opinions of EFSA,

• other factors legitimate to the matter under consideration, and
• the precautionary principle.

Can the Commission depart from an EFSA opinion?

Principles of Risk Analysis for Food Safety

Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand

► Direct application

■ EU rules are enforceable

• EU Court of Justice
• National courts

Principles of Risk Analysis for Food Safety

Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand

► Risk management

■ Other legitimate factors

Other factors relevant to the matter under consideration should legitimately be taken into account including:

• societal,
• economic,
• traditional,
• ethical and
• environmental factors and
• the feasibility of controls.

Principles of Risk Analysis for Food Safety

Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand

► Risk management - Precautionary principle Principles of Risk Analysis for Food Safety

Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand

► Risk management - Precautionary principle Principles of Risk Analysis for Food Safety

Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand

► Risk management - Precautionary principle Principles of Risk Analysis for Food Safety

Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand

Chernobyl food crisis (1986)

Problem: no scientific data on risk for human health from radioactive contamination of the food supply Commission Recommendation (2 May 1986) : Maximum: - 90 bq/kg for fruits and vegetables

• 125 bq/kg for dairy products

Council Regulation (Euratom) No 3954/87 (22 December 1987) Maximum:

• 1000 bq/kg for milk
• 1250 bq/kg for other food

► Risk management - Precautionary principle Principles of Risk Analysis for Food Safety

Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand

Belgian dioxin crisis (1999)

Problem: no scientific data on risk for human health of food obtained from animals fed with feed contaminated with dioxin 27.05.1999: the Belgian authorities inform the Commission about a heavy contamination of compound feedingstuff with dioxin 03.06.1999: the Commission decides to exclude potentially contaminated eggs, poultry, beef, pork and milk products from the market. 06.07.1999: the study of PCB/dioxin patterns reveals major differences in the metabolism of these compounds by farm animals 07.07.1999: the Commission removes sales and export restrictions on Belgian beef, pork and milk products 16.09.1999: Nature reveals that throughout the crisis the levels of dioxins in meat and eggs were low enough not to cause harm

► Risk management - Precautionary principle Principles of Risk Analysis for Food Safety

Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand

Regulation 178/2002 - Article 7

• In specific circumstances where,
• following an assessment of available information,
• the possibility of harmful effects on health is identified
• but scientific uncertainty persists,
• provisional risk management measures
• necessary to ensure the high level of health protection chosen in the [EU]
• may be adopted,
• pending further scientific information for a more comprehensive risk assessment.

Measures adopted […] shall be:

• proportionate […]
• no more restrictive of trade than is required […]
• reviewed within a reasonable period of time […]

► Risk management - Precautionary principle Principles of Risk Analysis for Food Safety

Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand

Regulation 178/2002 - Article 7

Provides a legal basis for risk management measures based on the PP ► to protect human, animal and plant health Provides a legal basis for challenging measures abusing the PP ► to protect: ● the internal market (e.g. ECJ judgement of 13 December 2001 in Case C-1/00)

• international trade

Principles of Risk Analysis for Food Safety

Training Workshop - 15-17 February 2013 - Chiang Mai,Thailand

Thank you!