EFSA general priorities

Per Bergman

Director of Scientific Evaluation of Regulated Products Directorate (REPRO)

ECPA-IBMA workshop with EFSA on evaluation on PPP

1 Committed since 2002 to ensuring that Europe’s food is safe

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EFSA gives advice from farm to fork Plant Health

Animal health and welfare and their diseases

Biological food

chain hazards

Food chain contaminants

Dietary, nutritional and

novel food

Plant Protection Genetically modified

organisms

Animal feed

Food additives Flavourings and Procesing aids

Food packaging

About EFSA

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What EFSA does

Who can task EFSA? European Commission European Parliament

EU Member States

Self-tasking

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EFSA’s guiding principles

• Scientific excellence • Independence • Openness • Transparency • Responsiveness

Core values

Organisation

Organisation

REPRO – Application areas

Main food and feed regulatory areas where REPRO is currently called to review applications

Responsible unit (REPRO Directorate)

Food additives Nutrient sources Flavourings Enzymes Food contact material

FIP

Feed additives FEED Genetically Modified Organisms (GMO) GMO Health claims Novel food Infant formulae Food allergies

NUTRITION

Plant Protection Products: active substances (PPP) and Maximum Residual Levels (MRL) PESTICIDES

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• REgulated

• PROducts

• Assess, advise, communicate

• Independent, based on sound science

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About REPRO

Provide scientific advice and support for EU legislation, policies in fields that impact food and feed safety

Provide independent information on all relevant matters Communicate the risks

Mandate

Scientific outputs

A.1. Opinions of Scientific Committee

(SC)/Scientific Panel (SP)

A.1.1 Opinion of the SC/SP

A.1.2 Statement of the SC/SP

A.1.3 Guidance of the SC/SP

A.2 Other EFSA scientific outputs A.2.1 Statement of EFSA

A.2.2 Guidance of EFSA

A.2.3 Conclusion on Pesticides Peer Review

A.2.4 Reasoned Opinion

A.2.5 Scientific Report of EFSA B. Supporting publications B.1 Technical Report

B.2 External Scientific Report

B.3 Event Report

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Publication of scientific outputs

http://www.efsa.europa.eu/en/publications/efsajournal.htm 10

Working together

• 30 national food safety agencies • 300 research institutes • Over 1500 experts

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Cooperation with:

• EU Agencies • 3rd country organisations

EFSA Outputs: Examination of authorisation dossiers

Outputs related to applications vs. total outputs

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Current applications workload

Steadily increasing applications in number and complexity • Since 2003 number of applications almost doubled • 900 new dossiers in 2010 - of which 450 on health claims

Applications typically come in bulk within large product

reviews (PPP, food and feed additives, health claims, etc.) More than 40% of EFSA budget spent on applications in 2011 The work in this area comprises 60-70% of the overall

EFSA´s scientific outputs Very complex legal environment evolving over time

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2013 priorities • Continuing high demand for scientific advice: 676

scientific outputs predicted

• Further boost risk assessment capacity: full implementation of EFSA Science Strategy 2012-2016; enhanced knowledge management programme; support for managing scientific literature; structured scientific data

• Dialogue with risk managers: multi-annuality

• Review of planning in scientific cooperation: efficiency of contracts & grants programme (€10.6 million); strategic and multiannual approach; workshops with stakeholders

• Continue enhancing EFSA’s efficiency: business process mapping

• EU economic/budgetary context and EU multi-annual financial framework 2014-2020

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Other priorities in 2013

• New services delivered by EFSA’s Application Helpdesk: interactions with SMEs, streamline of application procedures

• Electronic submission of applications: feasibility study and benchmarking with other EU agencies

• Human capital development: training for Panel members and EFSA staff, enhanced knowledge management programme

• Integrated quality management system: scientific outputs covered by December 2013

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2013 science highlights (I) Public health

– Meat inspection: scientific basis for the modernisation of meat inspection in EU, multidisciplinary

– Dietary reference values for micronutrients

– Plant toxicants

– Mycotoxins

– TSEs

– Metals, mercury in fish

– Perfluoro compounds

– Animal-based welfare indicators

Risk ranking: multiagency project, prioritisation of requests for work

Crisis preparedness: annual training and simulation exercises organised with Member States

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2013 science highlights (II) Application-related

– GMOs: cultivation and post-market environmental monitoring, guidance document on risk assessment of GM animals

– Health claims: Article 13.5 and Article 14/reevaluation of some Article 13 claims

– Pesticides: new active substances, renewals of approval, cumulative risk assessment

– Plastic food contact materials

– Recycled materials

– Process aids

– Flavourings, enzymes

– Novel foods

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