regulation(eu)no2832013andeunotice2013c9501.docVIP

Regulation (EU) No 283/2013 and EU Notice 2013/C 95/01 (New data requirements, OECD guidance/guidelines) Evaluation Report Prepared under Article 8 of Regulation (EC) No 396/2005 MRL application on the setting of [MRL(s) and Import tolerance(s)] in [commodities] [DD Month YYYY] [Logo of the institution] Evaluating Member State: [Member State] [Name of the institution] [Address of the institution] Table of Contents Background 4 The active substance and its use pattern 4 Assessment 4 1. Methods of analysis 4 1.1. Methods for enforcement of residues in food of plant origin 4 1.2. Methods for enforcement of residues in food of animal origin 5 2. Mammalian toxicology 5 3. Residues in Plants 9 3.1. Primary crops 9 3.1.1. Nature of residues (Metabolism studies) 9 3.1.2. Magnitude of residues (Residue trials) 10 3.1.3. Conversion factor for risk assessment for products of plant origin 13 3.1.4. Effect of industrial processing and/or household preparation 13 3.2. Rotational crops 15 3.2.1. Nature of residues (Confined metabolism study on rotational crops) 15 3.2.2. Magnitude of residues (Rotational field trials) 16 4. Residues in livestock 17 4.1. Dietary burden 17 4.2. Nature of residues 18 4.3. Magnitude of residues 19 4.4. Conversion factor for risk assessment for products of animal origin 22 5. Consumer risk assessment 22 5.1. Dietary Exposure 22 5.2. Other routes of exposure 24 Conclusions and recommendations 24 References 25 Appendix A – Good Agricultural Practices (GAPs) supported in the MRL application 26 Appendix B – Pesticide Residues Intake Model (PRIMo) 27 Appendix C - Detailed evaluation of the additional studies relied on 28 C.1. Methods of analysis 29 C.2. Mammalian toxicology 30 C.3. Residue data 33 C.3.1. Nature and magnitude of residues in primary crops 33 C.3.2. Nature and magnitude of residues in processed commodities 37 C.3.3. Nature and magnitude of residues in rotational crops 39 C.3.4. Nature and magnitude of residues in livestock