Urgency of harmonizing domestic pesticide analysis methods in agricultural and food raw materials, food products, feed and environmental objects according to the requirements of the European union, organization for economic cooperation and development. Part 1. General Aspects of Pre- and Post-Registration Methods for Pesticide Residue Analysis

  • Authors: V.D. Chmil
  • UDC: 581.57:543.393
  • DOI: 10.33273/2663-9726-2025-62-1-32-47
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L.I. Medved’s Research Center of Preventive Toxicology, Food and Chemical Safety Ministry of Health, Ukraine (State Enterprise), Kyiv, Ukraine

 

SUMMARY. Aim. To review the general aspects of the development and use of pre- and post-registration methods for pesticide residue analysis in the European Union (EU) and the Organisation for Economic Cooperation and Development (OECD) in food products, animal feed, and environmental objects, and to provide proposals for the development and implementation of domestic regulations in this field.

Materials and Мethods. Analytical review of the EU and OECD guidelines, legislative documents, and scientific publications devoted to the development and use of pesticide residue analysis methods for obtaining data to assess the impact of pesticides on human health (risk assessment) and the environment, for establishing maximum residue limits (MRLs) to ensure compliance with the established MRLs and monitoring objectives. Ukrainian legislative documents regulating the development and use of pesticide residue analysis methods for laboratory control need significant revision to align with the EU and OECD requirements.

Conclusions. Proposals have been formulated for the creation of domestic guidelines for the development and use of pesticide residue analysis methods for risk assessment, pre- and post-registration control, and monitoring objectives based on the EU and OECD guidelines.

Keywords: plant protection products (PPP), pesticides, maximum residue limits (MRLs), analysis methods, pre-registration methods for pesticide residue analysis, postregistration methods for pesticide residue analysis.

 

СПИСОК ВИКОРИСТАНИХ ДЖЕРЕЛ / REFERENCES

 

1. Organisation for Economic Co-operation and Development. Series on Pesticides. Number 39. Guidance Document on Pesticide Residue Analytical Method. ENV/JM/MONO(2007)17, OECD. Paris 2007:34. https://one.oecd.org>MONO(2007)17>pdf

2. SANTE/2020/12830 (combined guidance). Guidance Document on Pesticide Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes. SANTE Rev.2.2023:51 https://food.ec.europa.eu›system›files›pesti

3. Guidance SANTE 11312/2021 – Analytical quality control and method validation procedures for pesticide residues analysis in food and feed.SANTE 2022:57 https://food.ec.europa.eu.system

4. Ambrus АA, Ngoc Doan VV, Szenczi-Cseh J, Szemanne-Dobrik H, Adrienn Vásárhelyi A. Quality Control of Pesticide Residue Measurements and Evaluation of Their Results. Molecules. 28(3) 2023: 954. doi: 10.3390/molecules28030954.

5. ДСТУ EN ISO/IEC 17025:2019 Загальні вимоги до компетентності випробувальних та калібрувальних лабораторій (EN ISO/IEC 17025:2017,IDT; ISO/IEC 17025:2017, IDT). Київ ДП «Укр НДНЦ» 2020: 31. http://www.karantin.te.ua › file › untitled 2019. [DSTU EN ISO/IEC 17025:2019 General requirements for the competence of testing and calibration laboratories (EN ISO/IEC 17025:2017, IDT; ISO/IEC 17025:2017, IDT). Kyiv SE ‘Ukrainian research and training centre’, 2020: 31. URL: http://www.karantin.te.ua›file›untitled2019].

6. ДСТУ7392-2013Атестація методик виконання вимірювань.Основні положення та порядок виконання. Мінекономрозвітку України 2014: 11. URL: http://ksv.do.am›DSTU2›dstu_7392-2013 [DSTU 7392-2013 Certification of measurement methods. Ministry of Economic Development and Trade of Ukraine, 2014: 11. URL: http://ksv.do.am›DSTU2›dstu_7392-2013].

7. ДСТУ EN 482:2016 Повітря робочої зони. Загальні вимоги до характеристик методик вимірювання вмісту хімічних речовин (EN 482:2012+A1:2015, IDT). НІЦ «Леонорм» 22 с. [DSTU EN 482:2016 Workplace air. General requirements for the characteristics of methods for measuring the content of chemicals (EN 482:2012+A1:2015, IDT). SIC ‘Leonorm’. 22 p.]

8. ДСТУ EN ISO 15189:2015 Медичні лабораторії. Вимоги до якості та компетентності (EN ISO 15189:2012, IDT) «Укр НДНЦ» 52 с. https://zakon.isu.net.ua › sites › files › normdocs. [DSTU EN ISO 15189:2015 Medical laboratories. Quality and competence requirements (EN ISO 15189:2012, IDT) ‘Ukrainian research and training centre’ 52 p. URL: su.net.uahttps://zakon.isu.net.ua › sites › files › normdocs].

9. The manager’s guide to VAM, UK Department of Trade and Industry, Valid Analytical Measurement Programme. VAM Principles M.Sargent. Anal.Proc., 32. 1995: 201-202. doi.org/10.1039/ai19953200201.

10. Commission Regulation(EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market Official Journal of the European Union – L 93 2013: 85-152 ELI: http://data.europa.eu/eli/reg/2013/284/oj.

11. Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market. OJ L 93 2013: 85-93. ELI: http://data.europa.eu/eli/reg/2013/284/oj.

12. Technical Active Substance and Plant Protection products: Guidance for generating and reporting methods of analysis in support of pre- and post- registration data requirements for Annex(Section 4) of Regulation (EU) No 283/2013 and Annex (Section 5) of Regulation (EU) No 284/2013. SANCO/3030/99 rev.5 22 March 2019: 21. https://www.phytocontrol.com ›.

13. ДСТУ 7392-2013. Атестація методик виконання вимірювань.Основні положення та порядок виконання. Мінекономрозвітку України 2014: 11. URL: http://ksv.do.am › DSTU2 › dstu_7392-2013. [DSTU 7392-2013 Certification of measurement methods. Basic provisions and procedure for implementation. Ministry of Economic Development of Ukraine 2014: 11].

14. Guidelines on performance criteria for method of analysis for the determination of pesticide residue in food and feed. CXG 90-2017 FAO/WHO 2017:13 https://www.fao.org>sh-proxy.

15. Principle and Methods for the Risk Assessment of the Chemical in Food. Chapter 3 Chemical Characterization, Analytical Methods and the Development of Spercification. FAO WHO 2009:30. URL: https://inchem.org › ehc › ehc › ehc240_chapter 3.

16. ICH Topic Q2 (R1) Validation of analytical procedures. Text and Methodology. Int.Conf.Harmon EMA 2005:15. URL: https://www.ema.europa.eu › scientific-guideline.

17. Submission and evaluation of pesticide residues data for the estimation of maximum residues levels in food and feed. Third edition. FAO 2016:286 ISBN 978-92-5-109133-3. URL: https://www.fao.org ›.

18. Evalution of pesticide residues for estimation residue levels and calculation of dietary intake. Training manual. FAO 2016:500 ISBN 978-92-5-107114-4.

19. Regulation (EC) No1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC O J L 396 2006: 858. URL: https://www.fao.org › details.

20. European Commitee for Standardisation (CEN) EN 15662:2018. Foods of plant origin - Multimethod for the determination of pesticide residues using GC- and LC based analysis following acetonitrile extraction/partitioning and clean-up by dispersive SPE - Modular QuEChERS-method. 23 May 2018: 84. URL: https://standards.iteh.ai › cen.

21. Anastassiades M, Lehotay S, Štajnbaher D, Schenck F. Fast and Easy Multiresidue Method Employing Acetonitrile Extraction/Partitioning and “Dispersive Solid-Phase Extraction” for the Determination of Pesticide Residues in Produce Journal of AOAC International, Volume 86, Issue 2, 2003: 412–431. https://doi.org/10.1093/jaoac/86.2.412.

22. IUPAC Reports on Pesticides (40): Bound Xenobiotic Residues in Food Commodities of Plant and Animal Origin Pure Appl. Chem. Vol 70, No 7, 1998: 1423-1447. http://dx.doi.org/10.1351/pac199870071423.

 

Received January, 10, 2025