Pesticide Risk Assessment Peer Review PRAPeR

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Pesticide Risk Assessment Peer Review (PRAPeR)

• 15th May 2007

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Pesticide Risk Assessment Peer Review

• PRAPeR Unit 23 staff
• 2 scientist for physical-chemical properties /
  analytical methods
• 3 scientists for mammalian toxicology
• 2 scientists for residues
• 2 scientists for MRL
• 3 scientists for environmental fate and behaviour
• 3 scientists for ecotoxicology
• 8 co-ordination/administration (3 sci. 5
  admin.)

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Pesticide Risk Assessment Peer Review

• Council Directive 91/414/EEC concerning the
  placing of plant protection products on the
  market (Annex II and III data requirements for
  dossiers)
• Active substances are reviewed at EU level,
  positive list (Annex I) of active substances is
  set up (1 safe use)
• Evaluation by the Rapporteur Member State (RMS)
  is based on data package submitted by applicants
  on the a.s. 1 representative formulation (Draft
  Assessment Report)
• NAS and EAS (entry into force 2 ys -
  15/07/1993) review of EAS in 4 stages

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Pesticide Risk Assessment Peer Review

• EFSAs involvement in the review program for new
  active substances (NAS)
• No legal requirement
• Based on bilateral agreement between EFSA and
  EU-Commission
• Peer review of
• 4 chemical active substances finalised
• 17 chemical active substances ongoing
• 2 biological active substances ongoing
• 23 chemical and 6 biological active substances
  expected

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Pesticide Risk Assessment Peer Review

• Peer review status of the 2nd stage
• Of 52 active substances
• 52 draft assessment reports (DAR) distributed for
  comments
• 2 substances were withdrawn by the notifiers
• triazamate, naled
• 50 substances discussed in EPCO expert meetings
• All the conclusions are submitted to COM and the
  last conclusion was finalised on 28 July 2006

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Pesticide Risk Assessment Peer Review

• Peer review status of the 3rd stage
• Part A DARs for 64 active substances expected
• 59 DARs received from RMS so far (1 withdrawn)
• 58 DARs are available on CIRCA
• Part B DARs for 74 active substances expected
• 35 DARs received from RMS so far (3 withdrawn)
• 27 DARs are available on CIRCA

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Pesticide Risk Assessment Peer Review

• Peer review commenting phase

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Pesticide Risk Assessment Peer Review

• Peer review comment evaluation phase

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Pesticide Risk Assessment Peer Review
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Pesticide Risk Assessment Peer Review

• Peer review phase to address issues

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Pesticide Risk Assessment Peer Review
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Pesticide Risk Assessment Peer Review

• Organisation of the experts meetings
• Experts meetings are organised in 5 sections-
  identity, phys-chem properties, details of uses
  and further information, methods of analysis-
  mammalian toxicology- residues- environmental
  fate and behaviour- ecotoxicology.
• Based on comments made by MS and EFSA on the DAR,
  CL issues are often discussed at the experts
  meetings and proposals are made and forwarded to
  ECB.

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Pesticide Risk Assessment Peer Review

• Peer review - finalisation phase