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WTO Workshop on Risk Analysis
Geneva 13-14 October 2014
Risk assessment methodologies in various
sectors and how to respond to challenges ahead
Djien Liem
EFSA IS TASKED
TO
Provide independent scientific advice and support for EU law/policies on food and feed safety
Provide independent, timely risk communication
Promote scientific cooperation
AND NOT TO
develop food safety policies and legislation
adopt regulations, authorise marketing of new products
enforce food safety legislation
take charge of food safety/ quality controls, labelling or other such issues, like inspections and traceability
WORKING TOGETHER WITHIN EUROPE...
National food safety agencies / research organisations (Art. 36)
400 research institutes
1,500 experts
EU Agencies:
OUTSIDE EUROPE...
Working with national food safety organisations:
US: FDA, USDA APHIS, USDA FSIS, ARS, EPA
Health Canada
Food Safety Commission of Japan
Food Standards Australia and New Zealand
New Zealand Ministry for Primary Industries
Working with international organisations:
THE NATURE OF EFSA WORK IS CHANGING...
More work on regulated products
Not always predictable
Increased calls for responsiveness, more efficiency
Direct interest by industry, close scrutiny by other stakeholders
More guidance, better services
... AND DIVERSIFYING INTO NEW AREAS
Evaluation of the safety and environmental impact of new products
• e.g. novel food, additives
Development of new risk evaluation methods
• e.g. nanotechnology, active and intelligent packaging
• e.g. ‘omics’, less animal testing
Evaluation of efficacy/ benefits
• e.g. pesticides (2011), claims
Sustainable innovation =
safe, environmentally-friendly, backed by science
EU 2020
KEY OBJECTIVES IN 2012-2016
The quality of our science is central to everything we do
EFSA’s
Science
Strategy
2012-2016
Further develop EFSA’s scientific advice
Strengthen the scientific basis for
risk assessment and monitoring
Optimise the use of risk assessment
capacity in EU
Scientific CooperationRoadmap
Develop and harmonise methodologies to assess
risk in the food chain
... AND NEW RISKS AND CHALLENGES ARISING
Chemical mixtures/combined toxicity
Emerging antimicrobial resistance
Hazards linked to globalisation (plant pests, animal diseases, food-borne diseases outbreaks…)
9
CHALLENGES FOR ASSESSMENT PROCESS
Problem formulation
Exposure Assessment Hazard Identification
Hazard characterisation
Risk Characterisation
Risk Communication
10
CHALLENGES FOR ASSESSMENT PROCESS
Problem formulation
Exposure Assessment Hazard Identification
Hazard characterisation
Risk Characterisation
Risk Communication
Which methods?
Clarity of the question?
Impartiality
Relevance
Reliability
of the data?
Conclusions
balanced?
Uncertainties?
Knowledge gaps?
Answer clear?
Timeliness?
Transparency?
Open data access?
11
Transparency guidance
Guidance on handling of uncertainties
Guidance on weight of evidence
Guidance on biological relevance
Guidance on RA of chemical mixtures
Guidance on Environmental RA
In consultation with RA bodies (national, EU, International)
International harmonisation where possible, and where necessary
GUIDANCE DEVELOPMENT 2014-2016
Recommended