1. EFSA Trusted science for safe food Guilhem de Sèze
Head of Scientific Evaluation of Regulated Products (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. Ad hoc WG (average/year)
Working Groups 35
Active standing WG
1500
Experts 53
Ad hoc WG (average/year)

5. 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)

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. 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

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
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’

10. 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

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-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.

12. GMOs

13. 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

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. 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

16. 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

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