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U K NATIONAL AUTHORISATIONS Fay Beacon Pesticides Branch

U K NATIONAL AUTHORISATIONS Fay Beacon Pesticides Branch. Topics. Authorisation types and numbers Legislation Zonal process Applications to CRD Further information. Authorisation types. Authorisations for products used in agriculture, horticulture, forestry, home garden

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U K NATIONAL AUTHORISATIONS Fay Beacon Pesticides Branch

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  1. UK NATIONAL AUTHORISATIONS Fay BeaconPesticides Branch

  2. Topics • Authorisation types and numbers • Legislation • Zonal process • Applications to CRD • Further information

  3. Authorisation types • Authorisations for products used in agriculture, horticulture, forestry, home garden • Parallel permits (free trade within EU) • Experimental permits (for R&D) • Extensions of use (minor use – no efficacy) • Emergency authorisations • Adjuvants August 2010

  4. UK authorised products 3385 products (2735 Professional and 650 Amateur) Based on 270 active substances

  5. Legislation Applies directly in all MS from 14 June 2011 Applications received before 14 June 2011 still 91/414 (or national rules) 1107/2009 sets out procedures for most authorisation types. Adjuvants assessed under national rules as detailed rules not yet available.

  6. Regulation 1107/2009 • Sets out assessment procedures and timelines • Applications processed zonally - 3 zones (North, Central, South) - 1 zone for indoor use & seed treatments • Gives rules for data protection • Data requirements/ assessment standards currently same as 91/414

  7. 1107 zones

  8. The Zonal Process • Assessment by 1 MS (zonal RMS) comments by others (concerned MSs). Only national issues assessed by concerned MS • MS co-operation essential Developed by MS & COM Agrees process for implementation including zonal steering committees

  9. The Zonal Process - procedures under development • Main difference between assessment by ‘concerned MS’ and Mutual recognition is timing of submission. • EU database for management of product applications under development • Approach to risk assessment not harmonised - National assessment required • Choice of zonal RMS is industry’s, but high MS workloads making it difficult to agree zonal RMS

  10. Application types • Re-registration - workload peaks 2011- 2015 - zonal procedures but national timelines • New products & uses - zonal procedures and timelines - includes minor uses and mutual recognition • Amendments (e.g. name change) and withdrawals • Parallel permits • Experimental permits • Adjuvants (national rules) Total apps. 1500-2000 each year No MS comments

  11. Overview of zonal timelines Completion deadline Submission deadline ZRMS final Evaluation and authorisation ZRMS initial evaluation Comments by other MS 8 m 6 weeks 2.5 m - 6 m 0 m 12 m + 120 d 6 m (+6 m) Identification by ZRMS of further requirements Applicant alerts zonal reps, pre-submission meetings etc ‘Following’ Zonal (and MR) deadline • Clock stops for up to 6 months where further data requested (Timelines also suspended if an equivalence check is required)

  12. APPLICATION APPROVALS ADMIN SIFT REGISTRY FINANCE SIFT APRROVALS ADMIN FINANCE RESPONSIBLE OFFICER Request clarification EVALUATION SPECIALISTS Recommendation RESPONSIBLE OFFICER Govt. Depts. APPROVALS ADMIN

  13. Further Information • CRD Web Site http://www.pesticides.gov.uk/ • Public Information • Guidelines • European Union http://ec.europa.eu/food/plant/protection/evaluation/index_en.htm • ESFA http://dar.efsa.europa.eu/dar-web/provision - active substances

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