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