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Tallinn, 2 October 2017

Guilhem de Sèze Head of Scientific Evaluation of Regulated Products (REPRO). Tallinn, 2 October 2017. WORKFLOW ON SCIENTIFIC OPINIONS. Examine / accept mandate Select responsible panel(s) Select experts /Working Group Assess experts’ interests. QUESTIONS average/year (over 5 years).

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Tallinn, 2 October 2017

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  1. EFSA Trusted science for safe food Guilhem de Sèze Head of Scientific Evaluation of RegulatedProducts (REPRO) Tallinn, 2 October 2017

  2. WORKFLOW ON SCIENTIFIC OPINIONS • Examine / accept mandate • Select responsible panel(s) • Select experts /Working Group • Assess experts’ interests

  3. QUESTIONS average/year (over 5 years) 118 446 50 18

  4. Working Groups 53 Ad hoc WG (average/year) 35 Active standing WG 1500 Experts

  5. WORKFLOW ON SCIENTIFIC OPINIONS • Preparatory work (data collection, scientific literature, contracts and grants) • Working group – draft opinion • Panel plenary – peer review, validation • Publicconsultation • Adoption - transmission to requestor (Commission, Member States)

  6. WORKFLOW ON SCIENTIFIC OPINIONS • Message definition • Communications tools (press release, webstory, lay summaries, etc) • Publication (EFSA website, EFSA Journal) • Media and social media activities

  7. PESTICIDES

  8. The PESTICIDES Peer Review PROCESS PEER REVIEW EFSA, Rapporteurs MS, other Ms, EU Commision, Notifier, Public • Commentingphase • Evaluation of comments • Expert’sconsultation PAFF Nationalauthorisation PPP by MS

  9. Peer-review process of PESTICIDES • Solid and comprehensive system: Conducted by EFSA scientific staff and a network of appr. 600 risk assessment experts from the Member States • Ensuresharmonised and scientificallysoundviews • EU reviewcovers: • Open scientificliterature • Regulatorystudiessubmitted by applicant (burden of proof of safety) • Contributions of public • Assessment of ‘representative use’

  10. EFSA’s conclusion • Output of a scientific peer review • Identity and Phys/Chem properties • Mammalian Toxicology & Workers/Bystander/Residents risks • Residues & Consumers risks • Environmental Fate and Behaviour • Ecotoxicology & Environmental risks • Includes: • Data gaps and identified concerns • List of endpoints proposed by EFSA • Transparent to the outside: • Assessment of studies • All meeting minutes, comments

  11. Monitoring of PESTICIDES RESIDUES in food • Making sure pesticides levels in food are safe Based on EFSA’s advice, the European Commission and the Member States approve pesticides and set legal limits for residues (MRLs). • Europe-widecooperation to monitor pesticide residues • National authorities (EU + Iceland & Norway) analyse pesticide residues on more than 75,000 samples on food/year. • EFSA analyses the data and publishes a report annuallydetailing the percentage of samplescontainingresidueslevels with legallimits, but alsoassesses the exposure of EU consumersthroughtheirdiets(cumulative riskassessment). • EU decision-makers use these data as a basis for future actions such as monitoring activities, pesticides authorisationsand MRLs setting.

  12. GMOs

  13. GMOs: WHAT ARE THE MAIN ACTIVITIES?

  14. SCOPE OF GMO APPLICATIONS • Food • GMO for food use • Food containing or consisting of GMOs • Food produced from or containing ingredients produced from GMO • Feed • GMO for feed use • Feed containing or consisting of GMOs • Feed produced from GMOs • Deliberate release into the environment • Import and processing in Europe, but cultivated outside Europe • Seeds and plant propagation material for cultivation in Europe EFSA carries out scientific risk assessment on GMOs to ensure that they are as safe as their conventional equivalent

  15. Overall Opinion by EFSA GMO Panel WORKFLOW FOR GMO applicationS RISK ASSESSMENT GMO application (via a Member State) Applications of GM plants with scope cultivationOne Member State performs initial ERA All applications: Consultation with all Member States European Commission: draft decision Public consultation Member States and European Commission: Decision to authorize or not to authorize in Standing Committee RISK MANAGEMENT

  16. LIFE CYCLE OF GMO APPLICATIONS Scientific opinion dossier After 10 years: Renewal dossier (includes annual PMEM reports) EFSA reviews annual PMEM report in case of cultivation EFSA Pre-market risk assessment EFSA risk assessment of renewal application 10 years of commercial import or cultivation 10 years of commercial import/cultivation Scientific opinion Scientific opinion Member State and EC consent (including PMEM) Member State and EC consent (including PMEM/)

  17. HEALTH CLAIMS

  18. HEALTH CLAIMS and Probiotics Main reasons for unfavourable opinions • Food/constituent not sufficiently described • lack of information about the bacterial strain used in the study • Claimed effect • not sufficiently defined (e.g. gut health, general well-being) • or not considered a beneficial physiological effect (e.g. Increasing numbers of lactobacilli/bifidobacteria in the intestine) • Lack of relevant human studies of sufficient quality on which to base the claim for the intended population

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