EFSA Trusted science for safe food 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) 118 446 50 18

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

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

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

PESTICIDES

National authorisation PPP by MS The PESTICIDES Peer Review PROCESS PEER REVIEW EFSA, Rapporteurs MS, other Ms, EU Commision, Notifier, Public Commenting phase Evaluation of comments Expert’s consultation PAFF National authorisation PPP by MS

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 Ensures harmonised and scientifically sound views EU review covers: Open scientific literature Regulatory studies submitted by applicant (burden of proof of safety) Contributions of public Assessment of ‘representative use’

Output of a scientific peer review 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

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-wide cooperation 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 annually detailing the percentage of samples containing residues levels with legal limits, but also assesses the exposure of EU consumers through their diets (cumulative risk assessment). EU decision-makers use these data as a basis for future actions such as monitoring activities, pesticides authorisations and MRLs setting.

GMOs

Specific mandates from EC/DG SANTE GMOs: WHAT ARE THE MAIN ACTIVITIES? Applications for placing on the market Uses : food/feed import and processing, cultivation Scope: new GM products or their renewal Guidance documents for the risk assessment Specific mandates from EC/DG SANTE E.g. evaluation of reports/papers Recurrent requests from EC/DG SANTE E.g. annual PMEM (post market environmental monitoring) reports, evaluation of public comments

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

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

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

HEALTH CLAIMS

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