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Training session File Note and Registration Report, 23 rd October 2006 1 File Note : Partim Fate and Behavior in the environment 23 rd October 2006S. Vanhiesbecq FPS Health, Food Chain Safety and Environment DG Animals, Plants and Food Service Pesticides and Fertilizers
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Training session File Note and Registration Report, 23 rd October 2006 2 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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Training session File Note and Registration Report, 23 rd October 2006 3 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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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT Fate and behaviour of pesticides in Belgium - 27/09/2005 4 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, PEC soil,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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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT Fate and behaviour of pesticides in Belgium - 27/09/2005 5 Relevance of metabolites in groundwater Sequential assessment of the relevance for metabolites > 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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Training session File Note and Registration Report, 23 rd October 2006 6 Thank you for your attention
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