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Comparative assessment in the zonal system

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. Overview. Legal basis Zonal procedure

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Comparative assessment in the zonal system

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  1. 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. Overview • Legal basis • Zonal procedure • Criteria forcomparative assessment • Impact of comparative assessment • Somespecific cases

  3. Legal basis • Art. 40 of 1107/2009 : • Comparative assessment requiredforeveryapplicationforauthorisation, renewal or amendmentif the PPP contains a CfS • Substitutionrequiredif • A significantly safer andeconomicallyandtechnicallyfeasiblealternative is available • Enoughalternatives are availableto keep risk forresistance low • Minor uses are taken into account • For new activesubstances : possibilitytowaitfor 5 years • In exceptional cases “voluntary” substitution (without CfS) witha non-chemicalmethod in generaluse

  4. Legal basis • Art 41 : • Zonal procedure withzRMS • Mutual recognitionnotobligatory

  5. Zonal procedure • As soon as the list withCfS is applicable • Evaluation on a case by case bycMS : • Which a.s. are authorisedforusesappliedfor ? • Which non chemicalmethod is in use ? • Is experience of 5 yearneeded ? • List of usesforwhichsubstitution is feasible • Comparative assessment : risks versus benefits of substitution • Authorisationrestrictedtouses without acceptablealternatives • In case of renewal : restriction/refusalto take placeafter 3 years, forall PPP withthisCfS • Addinformation into (national) part A of dRR

  6. Criteria forcomparative assessment • EPPO Standard forcomparative assessment • Draft Guidance document forcomparative assessment • CommissionNotewithinstructions

  7. Criteria forcomparative assessmentEPPO Standard PP1/271 of 2011 • Mainprincipals : • Restrictedtoefficacy, resistanceand minor uses • Efficacytobecompared on pest level • Resistance : keep 2-4 substancesavailable (ifany !) with different mode of action/resistancemechanism • Minor use : keep a major usetomaintain the product on the market (willnot happen for minor usesalone)

  8. Criteria forcomparative assessment Draft Guidance document • Mainprincipals : • Complementaryto EPPO Standard PP1/271 • Restrictedto health and environment • Includestechnicalformulation issues (art 29,1 d) • Both mandatoryandoptionalcomparative assessment • Step-wise approach

  9. Criteria forcomparative 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. Criteria forcomparativeassessmentDraft 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. Criteria forcomparativeassessmentCommissionNotewithinstructions • Notepresented on WG Legislation of June - Mainprincipals : • A list of candidatesforsubsitutionwillbepublished, togetherwith an implementation date • Fromthis date, comparative assessment willbeobligatory • Two steps : first list foractivesubstancesapprovedbefore end of January 2013, second list with the rest • Substancesappliedforafter 14/06/2011 willdirectly at approvalbeclassified as candidatesforsubstitution or not • Mandatoryor optionalcomparative assessment on national level (afterzonalevaluation) • Mutual recognition : up to the Member States

  12. Impact of Comparative assessment • Black list of CfS • Number of formulationsinvolved • Lesspredictability

  13. Impact of comparative assessmentBlack list of CfS • List of CfS as soon as published • Black list forNGOsand media • Secundaryrequirements of distribution sector

  14. Impact of comparative assessmentNumber of formulationsinvolved • Draft Commissionlist 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 : • Workloadforreviewingactivesubstancesevery 7 year • Workloadforreviewingformulationsevery 7 year + CA • Belgium : 367 (of 1700) renewalsevery 7 year • = 182 renewals/year in stead of 170/year(+ 6,6 %)

  15. Impact of comparative assessmentLesspredictability • Entry into force of CA vsdevelopment time forformulation • Incertainties are build in into the procedure • Whichavailablealternatives at time of submission/evaluation ? • Whichalternativeuses at time of submission/evaluation ? • Belgium : 13 404 combinationsof crop – pest – a.s. • Will therebe return for the investment ?

  16. Somespecific cases Application for a PPP withCfS • New authorisation, renewal, extension of use • For every single use (crop-pest combination) appliedfor : • IfsameCfSalreadyauthorised : authorisationpossible (no benefit in refusingauthorisation) • IfotherCfSalreadyauthorised : authorisationif the otherCfS is notsignificantly safer (step 4 and 5) • If non-CfSalreadyauthorised : • Comparable Mode of Action : no authorisation as no benefit in authorisingCfS • OtherMoA : no authorisationifalready 2-3-4 MoAauthorised, depending on risk forresistancedevelopment

  17. Somespecific cases Application for a PPP withCfS (2) • For every single notyetauthoriseduse: authorisationpossible • Applyfornon authorised(minor) uses • Indicate major useneededto keep PPP on the market

  18. Somespecific cases Application fora PPP with a CfSand a non-CfSwithotherMoA • Same principles • Ifsame non-CfSalreadyauthorised: no authorisationifalready 2-3-4 MoAauthorised, depending on risk forresistancedevelopment

  19. Somespecific cases Application for a PPP with a CfSfor home and garden use • No suchthing as minor usesfor home and garden • If a non chemicalmethodis economicallyandpracticallyfeasiblefor non-professional users => no authorisation • Manual or mechanical weed-picking is feasible : no futurefor home and garden herbicideswithCfS ?

  20. Thankyouforyour 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

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