The document discusses some key issues with semiochemical active substance dossiers submitted for evaluation including: 1) A lack of detailed specifications and supporting analytical data for both active substances and impurities. 2) Sources of active substances are not always defined with specific plant locations. 3) Methods of manufacture are sometimes missing or lack detail. 4) Guidance on straight chain lepidopteran pheromones could be accepted except the trigger dose appears to be based on a personal communication rather than peer reviewed literature. 5) For other semiochemicals, comparisons to natural background levels need to be supported by measurable data from peer reviewed scientific literature.

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)