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.

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Presentation transcript:

Training session File Note and Registration Report, 23 rd October 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

Training session File Note and Registration Report, 23 rd October 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

Training session File Note and Registration Report, 23 rd October 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

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT Fate and behaviour of pesticides in Belgium - 27/09/ 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

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT Fate and behaviour of pesticides in Belgium - 27/09/ 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

Training session File Note and Registration Report, 23 rd October Thank you for your attention