Residues

Guidance for applicants on how to address the residues data requirements which apply under Regulation (EC) No 1107/2009.

Residue data should be generated in accordance with the available guidelines and guidance as listed in the resources below. Prior to submission applicants should also check that applications are complete using the Consumer Exposure section of the common omissions checklist.

Residue data are needed to support all pesticide uses which could result in pesticide residues in food or animal feed. Data on the nature and magnitude of pesticide residues in crops (including rotational crops and processed foods) and livestock resulting from the use of the formulation as recommended on the label are used to estimate consumer exposure. This includes exposure to the pesticide (and/or their derivatives, metabolites and reaction products) from the primary and following (rotational) crops, processed commodities or livestock products (for example meat, eggs, milk) from animal consumption of treated crops.

Pesticide uses for triazole pesticides will need to consider the additional guidance on Triazole Derivative Metabolites.

Residues data are also required to establish or demonstrate compliance with MRLs. Please also consider the guidance available at MRLs before submitting residues data.

Resources

Listed below are the guidelines for residue data that apply to:

• plant protection product (PPP) authorisation in Northern Ireland (NI)
• pesticide active substance approval, PPP authorisation and maximum residue (MRL) setting in Great Britain (GB)

Where GB has different guidelines to NI, additional links are given (for example Appendix D)

• 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:
• GB: Guidelines on comparability, extrapolation, group tolerances and data requirements for setting  MRLs (SANCO 7525/VI/95, 13/6/2017)
• NI: Data requirements for setting maximum residue levels, comparability of residue trials and extrapolation of residue data on products from plant and animal origin (SANTE/2019/12752 – 23/11/2020)

• 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)
• Technical guidelines for determining the magnitude of pesticide residues in honey and setting Maximum Residue Levels in honey (SANTE/11956/2016, 14/09/18)

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 (2016) Guidance Document on Crop Field Trials and Annexes. Series on Testing and Assessment No. 164 and Series on Pesticides No. 66
• OECD (2018). Guidance document on Residues in Rotational Crops. Series on Testing and Assessment No. 279 and Series on Pesticides No. 97