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Committed since 2002
                           to ensuring that Europe’s food is safe




  Semiochemicals: current review
programme-initial comments & key
            issues

                     Chris Lythgo
       Pesticides peer review environmental fate


 ECPA-IBMA workshop-EFSA evaluation of PPPs
            Parma 26 April 2012
Specification issues

• Lack of specifications and supporting data (batch
analyses)

• Sources not defined (Data requirements need
specific plant/s at specific location/s to be to be
reported)

•Methods of manufacture missing or lacking in detail

•Lack of methods for active substances and impurities

  Committed since 2002
  to ensuring that Europe’s food is safe
Phys Chem


    Active substances
•   The use of secondary literature is not accepted
    e.g. Merck
    Formulations
•   Cases for classification of properties were too
    brief
•   Representative formulations not reported for all
    active substances
•   Lack of methods for formulations
Residues


     • If application methods mean direct exposure of
       the plant by spraying occurs, information on
       potential for uptake needs to be provided
     • If significant uptake is not excluded, information
       on metabolism in plants needs to be provided
     • Consequent residues trials may be needed, if it
       is identified / concluded that toxicological
       reference values need to be set for any
       component of the residue definition
SH Platform, 22 June 2010
Environmental fate

• OECD guidance on straight chain lepidopteran
  pheromones could in principle be accepted, except the
  OECD trigger dose of 375g SCLP/ha/year appears to
  just be a ‘personal communication’
• When straight chain lepidopteran pheromones are
  applied by spraying, it appears there will be peak
  exposure above the OECD trigger, when expressed on a
  daily basis
• For other semiochemicals comparisons to natural
  background levels, need the background levels to be
  supported by measurements (the origin of which can be
  peer reviewed scientific literature)

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Chris Lythgo - Semiochemicals: Current review programme - initial comments and key issues

  • 1. Committed since 2002 to ensuring that Europe’s food is safe Semiochemicals: current review programme-initial comments & key issues Chris Lythgo Pesticides peer review environmental fate ECPA-IBMA workshop-EFSA evaluation of PPPs Parma 26 April 2012
  • 2. Specification issues • Lack of specifications and supporting data (batch analyses) • Sources not defined (Data requirements need specific plant/s at specific location/s to be to be reported) •Methods of manufacture missing or lacking in detail •Lack of methods for active substances and impurities Committed since 2002 to ensuring that Europe’s food is safe
  • 3. Phys Chem Active substances • The use of secondary literature is not accepted e.g. Merck Formulations • Cases for classification of properties were too brief • Representative formulations not reported for all active substances • Lack of methods for formulations
  • 4. Residues • If application methods mean direct exposure of the plant by spraying occurs, information on potential for uptake needs to be provided • If significant uptake is not excluded, information on metabolism in plants needs to be provided • Consequent residues trials may be needed, if it is identified / concluded that toxicological reference values need to be set for any component of the residue definition SH Platform, 22 June 2010
  • 5. Environmental fate • OECD guidance on straight chain lepidopteran pheromones could in principle be accepted, except the OECD trigger dose of 375g SCLP/ha/year appears to just be a ‘personal communication’ • When straight chain lepidopteran pheromones are applied by spraying, it appears there will be peak exposure above the OECD trigger, when expressed on a daily basis • For other semiochemicals comparisons to natural background levels, need the background levels to be supported by measurements (the origin of which can be peer reviewed scientific literature)