Guidelines - Maximum Residue levels

Technical Guidance

Guidelines for residue data under Regulation 1107/2009 (or former Directive 91/414/EEC) and Regulation EC 396/2005

Foreword - 1607/VI/97 - 10 June 1999

Please note that parts of the Annexes to Document 1607/VI/97 - 10 June 1999 may be outdated and replaced by the new guidelines (2015). In such cases the newer guidelines (2015) apply.

Appendix A - metabolism and distribution in plants - 7028/VI/95 - 22 July 97
Appendix B - general recommendations for the design, preparation and realisation of residue trials - 7029/VI/95 - 22 July 1997
Appendix C - testing of plant protection products in rotational crops - 7524/VI/95 - 22 July 1997
Appendix D - 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 - revision1 - 10 May 2023
Appendix E - processing studies - 7035/VI/95 - 22 July 1997
Appendix F - metabolism and distribution in domestic animals - 7030/VI/95 - 22 July 1997
Appendix G - livestock feeding studies - 7031/VI/95 - 22 July 1996
Appendix H - storage stability of residue samples - 7032/VI/95 - 22 July 1997
Appendix I - calculation of maximum residue levels and safety intervals - 7039/VI/95 - 22 July 1997
Appendix J - not yet applicable
- Working document on the nature of pesticides residues in fish (SANTE/10254/2021)
- Working document on the magnitude of pesticides residues in fish (SANTE/10252/2021)
- Working document on a Dietary burden calculator for pesticides residues in fish (SANTE/10250/2021)
  The dietary burden calculator is available here. The Commission is not responsible for its contents or any updates.

New guidelines (2015)

Analytical methods

Technical Guideline on the Evaluation of Extraction Efficiency of Residue Analytical Methods – SANTE/2017/10632. Rev.5 – 11 May 2023
Guidance document on analytical quality control and method validation procedures for pesticide residues analysis in food and feed - SANTE/11312/2021 version 2 – 22 November 2023
Working document on the summing up of LOQs in case of complex residue definitions - SANCO/12574/2014 rev.5.1, 30 November-1 December 2015
Residues Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes - SANTE/2020/12830. Rev 2 – 14 February 2023
Guidance provided by the EU Reference Laboratories for Pesticide Residues

Procedural guidance

Implementation of Regulation EC 396/2005

Information note on Article 20 of Regulation (EC) No 396/2005 as regards processing factors, processed and composite food and feed - SANTE/ 10704/2021 – 22 February 2022
Working document on the evaluation of data submitted to confirm MRLs - SANTE/10235/2016 Rev. 5.0 – 21 November 2023
Implementation of PRIMO rev 3.1 as agreed in PAFF residues 25-26 November 2019
Guidance document on criteria for the inclusion of active substances into Annex IV of Regulation (EC) No. 396/2005 - SANCO/11188/2013
MRL application form (Word version) - 4044/2008 - June 2016 - v10.2
MRL Application management 2015
Template Evaluation Report Addendum to Assessment Report New Data Requirements 2015
Evaluation Report New data requirements 2015
Evaluation Report Old data requirements 2015
Guidance Document on the MRL Setting Procedure 2021
SANTE/2015/10595 Rev. 5.4 – for MRL applications submitted before 27 March 2021
SANTE/2015/10595 Rev. 6.1 – for MRL applications submitted as of 27 March 2021

Transparency

Monitoring

Pesticide to be considered for inclusion in the national control programmes

'Working document on pesticides to be considered for inclusion in the national control programmes to ensure compliance with maximum residue levels of pesticides residues in and on food of plant and animal origin - SANCO/12745/2013, Rev.15(3), 21-22 November 2023