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Industry’s View on EFSA’s Contributions
to Pesticides Regulation


                        J.-P. Busnardo, DuPont
                         ECPA/IBMA Workshop
                              Parma, April 2012
Content



   Processes

   Active substances peer reviews

   MRLs

   Scientific Guidance
Processes


    Creation of PSC welcome

    Creation of Pesticides Unit welcome

    Creation of application desk welcome

    Should participate in Global Joint Reviews

    Ability to submit new information
    unnecessarily restricted (process design,
    not under EFSA control)
Peer Review of Active Substances


  Timelines overall respected
  Science:
  – Robust …
  – …often conservative
  Some important EFSA comments arrive late in
  review process
  – Little/no time left to applicant for adapting
  – Commenting opportunity only after report issued
Other issues in active substance
evaluations


    Amending active substance approvals


    POPs-PBT


    Scientific peer review open literature
Residues – MRL Reasoned Opinions


    Timelines overall respected (new MRLs)
    Article 12
    – Much delayed (but largely unavoidable)
    – Too many GAPs reviewed?
    Science
    – Robust…
    – … somewhat conservative
    Guidelines followed
    – Outcome predictable
Residues – Annual Report


    Very useful !

    Comprehensive

    Carefully written

    – Limits misuse/misinterpretation
Scientific Guidance


  Authors are not users!
  Often disconnected from use context
  Limited evaluation of guidance to be replaced
  – No systematic justification
  – No impact assessment
  Too often unnecessarily:
  – Conservative
  – Complex
  No mechanism for MS to amend EFSA opinion
  Need to be peer reviewed by MS and properly
  enforced
Conclusions


    Processes

    Active substances

    MRLs

    Residue annual report

    Scientific Guidance
Thank You !

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J.P Busnardo - ECPA industry feedback

  • 1. Industry’s View on EFSA’s Contributions to Pesticides Regulation J.-P. Busnardo, DuPont ECPA/IBMA Workshop Parma, April 2012
  • 2. Content Processes Active substances peer reviews MRLs Scientific Guidance
  • 3. Processes Creation of PSC welcome Creation of Pesticides Unit welcome Creation of application desk welcome Should participate in Global Joint Reviews Ability to submit new information unnecessarily restricted (process design, not under EFSA control)
  • 4. Peer Review of Active Substances Timelines overall respected Science: – Robust … – …often conservative Some important EFSA comments arrive late in review process – Little/no time left to applicant for adapting – Commenting opportunity only after report issued
  • 5. Other issues in active substance evaluations Amending active substance approvals POPs-PBT Scientific peer review open literature
  • 6. Residues – MRL Reasoned Opinions Timelines overall respected (new MRLs) Article 12 – Much delayed (but largely unavoidable) – Too many GAPs reviewed? Science – Robust… – … somewhat conservative Guidelines followed – Outcome predictable
  • 7. Residues – Annual Report Very useful ! Comprehensive Carefully written – Limits misuse/misinterpretation
  • 8. Scientific Guidance Authors are not users! Often disconnected from use context Limited evaluation of guidance to be replaced – No systematic justification – No impact assessment Too often unnecessarily: – Conservative – Complex No mechanism for MS to amend EFSA opinion Need to be peer reviewed by MS and properly enforced
  • 9. Conclusions Processes Active substances MRLs Residue annual report Scientific Guidance