The document discusses several issues related to evaluating the safety of botanical active substances for use in plant protection products and biocides. It notes limited toxicology data available for many botanicals due to a lack of standardized testing methods. It also raises questions around defining the identity of active substances in botanicals and ensuring representative marker compounds are used in required studies.

1. Committed since 2002
to ensuring that Europe’s food is safe
Botanicals
Jeff Pim, Team leader section 1

2. Identity, physchem, methods
• Lead compound concept
• Marker compound concept (how many, tox
relevant, representative)
• Published literature (physchem data)
• Methods usually not fully validated, ISO methods
accepted.
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3. Mammalian toxicology
• Limited quality of the database (few types of
studies available, no GLP, no guidelines, etc..)
• Identity of the a.s.? (difficult definition)
• Usually only acute studies available how can an
ADI/ARfD be set.
• Other sources of exposure v PPP use.
• Need of guidance
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4. Residues
• Metabolism of what, lead/marker compound.
• Residue trials what to analyse for.
• Quantitative risk assessment.
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5. Fate and behaviour
• Natural background level not exceeded.
• Ready biodegradability studies show complete
mineralisation.
• If neither of these apply then data on
degradation route and rate is needed.
• Known toxic transformation compounds.
• Indicator compounds must be shown to be
representative
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6. Ecotox
• Lead compound or marker compounds are
representative.
• Comparison of batches used with sources.
• Volatilisation followed by deposition.
• For indoor uses the potential risk for the
biological methods for sewage treatment needs
to be addressed.
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