1. 28/06/2018 Public Hearing EU Parliament, Brussels
Authorisation of plant protection products in Belgium Maarten Trybou FPS Public Health, Food Chain Safety and Environment DG Animals, Plants and Food Service Plant Protection Products and Fertilisers
28/06/2018
Public Hearing EU Parliament, Brussels

2. Belgium
1 Federal state 3 Regions (Flanders, Walloonia, Brussels-capital) 4 Communities (Dutch, French, Dutch+French, German)

3. Map of Belgian regions and communities

4. PPP relevant competences
Federal : placing on the (national) market, representation of Belgium for EU, labour protection, food safety Regions : agriculture, environment, waste, use (of PPP and of alternatives to PPP) Communities : education, health (prevention part of health policy)

5. Organisation at federal level
Federal Public Service (= federal ministry) of Public Health, Food Chain Safety and Environment
DG Animals, Plants and Food
Service Plant Protection Products and Fertilisers :
Evaluation of applications for plant protection products, maximum residu levels and active substances
Organisation of national Authorisation Board
National authorisation of plant protection products
Belgian position for voting in SCoPAFF (active substance approvals, Maximum Residue Levels)
Federal and national action plan for ppp
Certificate for professional use and sale

6. Organisation at federal level (2)
Federal Public Service (= federal ministry) of Public Health, Food Chain Safety and Environment
DG Environment
Inspection Service :
Enforcement for non food chain aspects (home and garden, ornamentals)

7. Organisation at federal level (3)
Federal Agency for Food Chain Safety
DG Control policy
DG Control
DG Laboratories
Control of the use, sale and storage of ppp (federal conditions)
Annual control programme for chemical analysis of ppp on the market
Annual control programme for residues in plant products
National contact point for enforcement
Audit committee, scientific committee, consultation committee
Certification of spraying equipment (together with regions)

8. Supporting organisations
Sciensano : federal research instance High Board for public health

9. Organisation at federal level

10. Organisation at regional level
Regional ministries of environment and agriculture
General measures for protection of the environment and for promotion of agriculture, including enforcement
Integrated Pest Management
Cross compliance conditions and follow-up (enforcement)
Regional action plan for ppp
Representation of regions in national Authorisation Board for PPP

11. Federal authorisation of PPP
Applications for PPP Applications for active substances Applications for MRLs Evaluation and authorisation National authorisation procedure

12. Applications for plant protection products
Zonal
Interzonal
Renewal
Extensions of use
Modification of composition, of labelling, of use, of active substance source, of use restrictions,…
Parallel import certificates
Experimental products (import and use certificates)
About 1000 applications in total per year

13. Applications for active substances
Approval of new active substances (Reporting Member State, co-RMS) Renewal of approval (Reporting Member State, co-RMS) Peer review, commenting on DARs of other RMS Technical equivalence of active substances Modification of approval restrictions Confirmatory data Adverse data

14. Applications for MRLs
New MRLs Revision of MRLs Extension for minor uses and crops

15. National authorisation procedure (1/3)
Application filing by application managers Evaluation of the application by evaluators Presentation to the Authorisation Board Advice by the Authorisation Board Communication to applicant by application manager (RR + Authorisation + authorisation letter)

16. National authorisation procedure (2/3)
3 teams of evaluators (both ppp and a.s.) :
Human toxicology/residues
Ecotoxicology/ fate and behaviour in the environment
Physical-chemical analysis/efficacy
2 teams of application managers (only ppp):
Authorisation and renewal of authorisations
Use extension of existing authorisations (incl. minor uses) and certificate for professional use and sale

17. National authorisation procedure (3/3)
Active substances : output of evaluation of the application = Draft Assessment Report or Renewal Assessment Report +- 7 evaluators => 2 DARs/RARs per year Plant protection products : output of evaluation of the application = Registration Report + Authorisation certificate evaluators => RR per year 4 application managers for zonal authorisations 4 application managers for renewals 1 application manager for mutual recognition 1 application manager for parallel import certificates 1 application manager for other applications (“flying keeper”)

18. National Action Plan for PPP
1 co-ordinator for the federal and national action plan
Federal actions, actions of the regions and joint actions
Co-ordination of federal actions
Co-ordination with regions
Consultation platform with stakeholders
Contact point for EU (Sustainable Use Directive)

19. Thank you for your attention !