2. Health and Safety Executive Active Substance Approval Matt Burns Pesticides Branch

3. Legislation Regulation 1107/2009: concerning the placing of plant protection products on the market -(previously under Directive 91/414/EEC) Articles 4 – 27 of 1107 deal with Active Substance Approval First Approval 10 years under 1107 (subsequent 15 years)

4. Pesticides Branch responsibilities (actives) Manages the CRD evaluations and inputs - –EU (UK RMS) Review of existing active substances –EU new active substances (chemical, biological) –Inputs into other MS evaluations and EU process –Provides internal information sources on EU active evaluations and programmes

5. Submissions New active substances (NAS) Evaluation –Any substance not on EC market when directive 91/414 came into force July 1993 Existing active substances (EAS) Reviews - Active substances on EC market in July 1993 Renewals (of the approval) Supported by large set of data ‘a dossier’

6. Active Substance Work Volumes New Substance evaluations ~5 – 10 Active substances per year Reviews/Renewals evaluations under EC programmes ~ 5 -10 Active substances per year 29 active substances currently in EFSA peer review process

7. Milestones Dossier Completeness/Admissibility Check 45 days of receipt Detailed Evaluation 1 year from confirming admissable

8. Fees Completeness/admissibl. check £5,000 Full Dossier Evaluation: Chemical pesticide – £110,000 Core evaluation + £35,000 EFSA peer review (+ £ 35,000 UK approval) Biocontrol agents/semiochemals - £ 13,000 – 22,500 (+ £7,500 EFSA peer review) Partial (smaller) dossier: £7,500 - £90,000

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12. Dossier evaluation – CRD process

13. Dossier Completeness/admissibility Checking Identifying any potential gaps or requesting clarification Company responds Hopefully, accepted as ready for detailed evaluation EU Completeness forms and Report submitted (COMM, EFSA)

14. CRD Dossier Evaluation (1 year) Project Manager (PM) Assigned Invoiced for full fee PM commissions evaluation Data Distributed Holds ‘Initiation Meeting’ of the team Request internal Peer Review and Data used Specialists Evaluate the Data Check ‘cut off’ criteria Request further information/data? PM Acts as a Contact Point PM Collates Draft Assessment Document

15. Evaluation Stage – Authors’ Meeting Author’s Meeting (specialists, PM) Regulatory Proposal is reached Key issues identified Possibly need to consult with: –Policy/Legal –Applicant Reminder – Record of Peer Review and Data Used

16. EU PROCESS - OVERVIEW Risk Assessment Risk Management Applicant Rapporteur SCFAH EFSA COM DossierDAR (1 year) Conclusion (up to 9 months) Proposal Vote APPROVAL DATA ~ Two Years ~ 9 Months Product Zonal Applications?

17. Applicant RMS evaluation PPR Panel Dossier DAR RMS Response EFSA ‘Written’ Procedure MS Peer Review Reporting table & endpoints Praper expert Praper expert Praper expert Evaluation Table List of studies EFSA Conclusion to COM Praper report/Updated Evaluation Table Draft EFSA Conclusion/ Our comments SCFAH Vote Publication RMS Response EU Process Expanded