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

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

Map of Belgian regions and communities

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)

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

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)

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)

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

Organisation at federal level

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

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

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

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

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

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)

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

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 +- 20 evaluators => +- 100 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”)

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)

Thank you for your attention ! Maarten.Trybou@health.belgium.be