File Note :

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• File Note
• Partim Fate and Behavior in the environment
• 23rd October 2006 S. Vanhiesbecq
• FPS Health, Food Chain Safety and Environment
• DG Animals, Plants and Food
• Service Pesticides and Fertilizers

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File Note partim Fate behavior in the
environment

• No data on fate Behavior is required
• Unless
• -existing problem on groundwater contamination
• or
• -1 active substance included in annex I of the
  Dir. 91/414/EEC

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Existing problem of groundwater contamination

Regular exceedance of the threshold value of 0,1
µg/L should be reported in detail by the
applicant to the Authorization Committee An
appropriate solution should be proposed
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Substance included in Annex I

• An appropriate annex III dossier has to be
  delivered
• doc C copies of existing or proposed labels
• doc D1 details of the intended uses in Belgium
• doc N overall summary and assessment
• Annex III summaries
• doc L-III references
• doc M-III (degradation, mobility,
  PECsoil,gw,sw)
• Annex III doc K
• Note
• PECgw calculated with European FOCUS scenarios
  accepted
• Relevance of metabolites with guideline
  Sanco/221/2000-rev.10-final

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Relevance of metabolites in groundwater

• Sequential assessment of the relevance for
  metabolites gt 0.1 µg/L
• Step 1. Exclusion of degradation products of no
  concern
• Step 2. Quantification of potential gw
  contamination
• Step 3. Hazard Assessment
• Stage 1 Screening for biological activity
• Stage 2 Screening for genotoxicity
• Stage 3 Screening for toxicity
• Step 4. Exposure assessment threshold of
  concern approach (0.75 µg/L)
• Step 5. Refined risk assessments for non-relevant
  metabolites
• max. limit concentration 10 µg/L

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• Thank you for your attention