1. UK NATIONAL AUTHORISATIONS Fay Beacon Pesticides 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) No MS comments Total apps. 1500-2000 each year

11. Overview of zonal timelines Submission deadline Completion deadline 0 m12 m - 6 m Applicant alerts zonal reps, pre-submission meetings etc ZRMS initial evaluation 8 m 6 weeks Comments by other MS 2.5 m ZRMS final Evaluation and authorisation Identification by ZRMS of further requirements 6 m + 120 d ‘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) (+6 m)

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

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 http://ec.europa.eu/food/plant/protection/evaluation/index_en.htm ESFA http://dar.efsa.europa.eu/dar-web/provisionhttp://dar.efsa.europa.eu/dar-web/provision - active substances