1. Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT Comparative assessment in the zonal system Maarten Trybou Service Pesticides & Fertilisers - Belgian authority for the authorisation of plant protection products ECPA/ECCA Conference, 12-13 March 2014, Brussels

2. Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT Overview Legal basis Zonal procedure Criteria for comparative assessment Impact of comparative assessment Some specific cases

3. Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT Legal basis Art. 40 of 1107/2009 : Comparative assessment required for every application for authorisation, renewal or amendment if the PPP contains a CfS Substitution required if -A significantly safer and economically and technically feasible alternative is available -Enough alternatives are available to keep risk for resistance low -Minor uses are taken into account For new active substances : possibility to wait for 5 years In exceptional cases “voluntary” substitution (without CfS) with a non-chemical method in general use

4. Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT Legal basis Art 41 : Zonal procedure with zRMS Mutual recognition not obligatory

5. Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT Zonal procedure As soon as the list with CfS is applicable Evaluation on a case by case by cMS : -Which a.s. are authorised for uses applied for ? -Which non chemical method is in use ? -Is experience of 5 year needed ? -List of uses for which substitution is feasible -Comparative assessment : risks versus benefits of substitution -Authorisation restricted to uses without acceptable alternatives -In case of renewal : restriction/refusal to take place after 3 years, for all PPP with this CfS Add information into (national) part A of dRR

6. Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT Criteria for comparative assessment EPPO Standard for comparative assessment Draft Guidance document for comparative assessment Commission Note with instructions

7. Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT Criteria for comparative assessment EPPO Standard PP1/271 of 2011 Main principals : Restricted to efficacy, resistance and minor uses Efficacy to be compared on pest level Resistance : keep 2-4 substances available (if any !) with different mode of action/resistance mechanism Minor use : keep a major use to maintain the product on the market (will not happen for minor uses alone)

8. Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT Criteria for comparative assessment Draft Guidance document Main principals : Complementary to EPPO Standard PP1/271 Restricted to health and environment Includes technical formulation issues (art 29,1 d) Both mandatory and optional comparative assessment Step-wise approach

9. Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT Criteria for comparative assessment Draft Guidance document (2) Step 1 - assessment in relation to Article 29(1)(d) Obligatory for every authorisation : the technical formulation is limiting exposure (e.g. labelling solvent/ formulation type) Step 2 - optional assessment in steps I-IV (Article 50(2)) Optional comparison with non-chemical or prevention method, also for PPP without candidate for substitution Step 3 – mandatory assessment starting with agronomic aspects (EPPO standard PP1/271)

10. Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT Criteria for comparative assessment Draft Guidance document (3) Step 4 - first step of assessment for health and the environment Comparison for the criteria used for classification as candidate for substitution (ADI, ARfD, NOAEL, persistence, etc..) Step 5 – second step of assessment for health and the environment Comparison for other aspects of risk assessment Step 6 – balance disadvantages against risk reduction Substitution or amendment of authorisation/application (or not)

11. Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT Criteria for comparative assessment Commission Note with instructions Note presented on WG Legislation of June - Main principals : A list of candidates for subsitution will be published, together with an implementation date From this date, comparative assessment will be obligatory Two steps : first list for active substances approved before end of January 2013, second list with the rest Substances applied for after 14/06/2011 will directly at approval be classified as candidates for substitution or not Mandatory or optional comparative assessment on national level (after zonal evaluation) Mutual recognition : up to the Member States

12. Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT Impact of Comparative assessment 1.Black list of CfS 2.Number of formulations involved 3.Less predictability

13. Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT Impact of comparative assessment Black list of CfS List of CfS as soon as published Black list for NGOs and media Secundary requirements of distribution sector

14. Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT Impact of comparative assessment Number of formulations involved Draft Commission list as far as Belgium concerns : In total 324 a.s. of which 71 CfS (22 %) Professional use 320 a.s. of which 69 CfS (21,5 %) Non professional use 71 a.s. of which 17 CfS (24%) (7 HE, 6 FU, 4 IN) Consequence : Workload for reviewing active substances every 7 year Workload for reviewing formulations every 7 year + CA Belgium : 367 (of 1700) renewals every 7 year = 182 renewals/year in stead of 170/year (+ 6,6 %)

15. Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT Impact of comparative assessment Less predictability Entry into force of CA vs development time for formulation Incertainties are build in into the procedure Which available alternatives at time of submission/evaluation ? Which alternative uses at time of submission/evaluation ? Belgium : 13 404 combinations of crop – pest – a.s. Will there be return for the investment ?

16. Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT Some specific cases Application for a PPP with CfS New authorisation, renewal, extension of use For every single use (crop-pest combination) applied for : If same CfS already authorised : authorisation possible (no benefit in refusing authorisation) If other CfS already authorised : authorisation if the other CfS is not significantly safer (step 4 and 5) If non-CfS already authorised : -Comparable Mode of Action : no authorisation as no benefit in authorising CfS -Other MoA : no authorisation if already 2-3-4 MoA authorised, depending on risk for resistance development

17. Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT Some specific cases Application for a PPP with CfS (2) For every single not yet authorised use : authorisation possible -Apply for non authorised (minor) uses -Indicate major use needed to keep PPP on the market

18. Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT Some specific cases Application for a PPP with a CfS and a non- CfS with other MoA Same principles If same non-CfS already authorised : no authorisation if already 2-3- 4 MoA authorised, depending on risk for resistance development

19. Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT Some specific cases Application for a PPP with a CfS for home and garden use No such thing as minor uses for home and garden If a non chemical method is economically and practically feasible for non-professional users => no authorisation Manual or mechanical weed-picking is feasible : no future for home and garden herbicides with CfS ?

20. Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT Thank you for your attention ! Maarten.Trybou@health.belgium.be Service Pesticides & Fertilisers - Belgian authority for the authorisation of plant protection products ECPA/ECCA Conference, 12-13 March 2014, Brussels