The following page is intended to provide guidance to applicants on how to address the residue and consumer exposure data requirements which apply under Regulation (EC) No 1107/2009.
Before a pesticide is approved residue data are needed to support all uses on crops for human or animal consumption, as well as for uses in food storage. Residue data should be generated in accordance with the available guidelines and guidance as listed in the resources below. In addition to consulting the below guidance and resources, applicants should check that their applications are complete using the Consumer Exposure section of the common omissions checklist.
Data on the nature and magnitude of pesticide residues in crops (including following crops and processed crops) and livestock are used to assess the risks to consumers resulting from the use of the formulation as recommended on the label. This includes exposure to the pesticide (and/or their derivatives, metabolites and reaction products) from the primary and following crops, processed commodities or livestock to which the crop has been fed. Further information on consumer exposure.
Residues data are also required to establish or demonstrate compliance with MRLs.
Appendix A-I below are available at: EC Website - Guidelines - Maximum Residue Levels (under heading:Guidelines for residue data under Directive 91/414/EEC and Regulation EC 396/2005)
Appendix A- Metabolism and Distribution in Plants (SANCO 7028/VI/95, 22/7/1997 )
Appendix B- General Recommendations for the design, preparation and realisation of residue trials (SANCO 7029/VI/95, 22/7/1997)
Appendix C- Testing of plant protection products in rotational crops (SANCO 7524/VI/95, 22/7/1997)
Appendix D- Comparability, extrapolation, group tolerances and data requirements. (SANCO 7525/VI/95, 24/3/2011)
Appendix E- Processing studies (SANCO 7035/VI/95, 22/7/1997)
Appendix F- Metabolism and distribution in domestic animals (SANCO 7030/VI/95, 22/7/1997)
Appendix G- Livestock feeding studies (SANCO 7031/VI/95, 22/7/1996)
Appendix H- Storage stability of residue samples (SANCO 7032/VI/95, 22/7/1997)
Appendix I- Calculation of Maximum Residue levels and safety intervals (SANCO 7039/VI/95, 22/7/1997)
OECD Test Guidelines (documents listed below are available at this link)
501: Metabolism in crops
502: Metabolism in rotational crops
503: Metabolism in livestock
504: Residues in rotational crops
505: Residues in livestock
506: Stability of pesticide residues in stored commodities
507: Nature of the pesticide residues in processed commodities
508: Magnitude of the pesticide residues in processed commodities
509: Crop field trials
OECD guidance (documents listed below are available at this link)
OECD (2008). Guidance document on magnitude of pesticide residues in processed commodities. Environment, Health and Safety Publications. Series on Testing and Assessment No. 96
OECD (2009). Guidance Document on the Definition of Residues. Environment, Health and Safety Publications. Series on Testing and Assessment No. 63 and Series on Pesticides No. 31
OECD (2009). Guidance Document on Overview of Residue Chemistry Studies (as revised in 2009). Environment, Health and Safety Publications. Series on Testing and Assessment No. 64 and Series on Pesticides No. 32
OECD (2011) Guidance Document on Crop Field Trials (Series on Testing and Assessment No. 164 and Series on Pesticides No. 66)