{"id":4752,"date":"2021-03-08T15:35:52","date_gmt":"2021-03-08T15:35:52","guid":{"rendered":"https:\/\/lynxee.consulting\/?p=4752"},"modified":"2023-01-26T14:47:56","modified_gmt":"2023-01-26T14:47:56","slug":"europe-com-publication-of-a-new-guidance-document-on-analytical-methods","status":"publish","type":"post","link":"https:\/\/lynxee.consulting\/en\/europe-com-publication-of-a-new-guidance-document-on-analytical-methods\/","title":{"rendered":"EUROPE &#8211; COM: Publication of a new guidance document on analytical methods"},"content":{"rendered":"<p style=\"text-align: justify\">On 24 February 2021, the European Commission has published a new guidance document (<a href=\"https:\/\/ec.europa.eu\/food\/sites\/food\/files\/plant\/docs\/pesticides_mrl_guidelines_2020-12830.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"><b>SANTE\/2020\/12830, Rev.1<\/b><\/a>) on pesticide <b>analytical methods for risk assessment and post-approval control and monitoring control<\/b>.<\/p>\n<p style=\"text-align: justify\">This document has been finalised in the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF &#8211; section Phytopharmaceuticals &#8211; Pesticides Residues) on 22-23 February 2021. It <b>supersedes<\/b> guidance documents <b>SANCO\/3029\/99<\/b> (requirements for analytical methods used in pre-registration for risk assessment) and <b>SANCO\/825\/00<\/b> (requirements for analytical methods for post-approval control and monitoring purposes) and is <b>applicable since 01 March 2021<\/b>.<\/p>\n<p style=\"text-align: justify\">The main directives of these two previous documents are restated, but further details and explanations have been included. New points are also developed:<\/p>\n<ul style=\"text-align: justify\">\n<li>Possible use of <b>isotopically labelled internal standard <\/b>for methods using mass spectrometry as detection system.<\/li>\n<li>If a hydrolysis step is necessary (if esters, amides and\/or conjugates are included in the residue definition and that the structures of the conjugates are unknown or no conjugate standard is available), the <b>efficiency of hydrolysis <\/b>step must be demonstrated.<\/li>\n<li><b>Individual recovery data<\/b> must be detailed in addition to mean recoveries for each matrix and each fortification level.<\/li>\n<li>Further explanations on <b>matrix effects<\/b> and mathematical formula to calculate them.<\/li>\n<li>For the <b>analytical calibration<\/b>, the suitability of the chosen function should preferably be demonstrated by a <b>residual analysis <\/b>rather than reporting the coefficient of correlation (r) or determination (R\u00b2).<\/li>\n<li>The limit of detection (<b>LOD<\/b>) must be determined and correspond to the <b>lowest calibration standard<\/b> (preferably in matrix) rather than calculated from the signal-to-noise ratio in control samples.<\/li>\n<li>Examples for <b>acceptable\/non-acceptable deviations of an independent laboratory validation<\/b> (ILV) from the primary method.<\/li>\n<li><b>Stability of the extracts and standards <\/b>must be demonstrated.<\/li>\n<li><b>Extraction efficiency<\/b> must be demonstrated in accordance with the guidance document <a href=\"https:\/\/ec.europa.eu\/food\/sites\/food\/files\/plant\/docs\/pesticides_mrl_guidelines_wrkdoc_2017-10632.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"><b>SANTE 2017\/10632 Rev. 3<\/b><\/a>.<\/li>\n<li>For the post-approval control and monitoring methods, the following are now required:\n<ul>\n<li>the determination of the residues in <b>honey<\/b> (primary method + confirmatory method + ILV);<\/li>\n<li>an <b>ILV <\/b>for the determination of residues in <b>drinking water or groundwater;\u00a0<\/b><\/li>\n<li>an analytical <b>method<\/b> for the determination of residues in <b>body fluids and tissues, regardless the toxicological classification of the active substance and\/or metabolites<\/b> (primary method + confirmatory method).<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p style=\"text-align: justify\">Appendix 1 lists all foodstuffs of plant origin and processed commodities and the group of matrices associated with them (high-water, high-acid, high-oil, dry or difficult to analyse commodities) and Appendix 2 gives an overview of methods required.<\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify\"><b>To download:\u00a0<\/b><\/p>\n<p style=\"text-align: justify\"><a href=\"https:\/\/ec.europa.eu\/food\/sites\/food\/files\/plant\/docs\/pesticides_mrl_guidelines_2020-12830.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">SANTE\/2020\/12830, Rev.1 (24.02.2021) &#8211; Guidance Document on Pesticide Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes<\/a><\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify\"><b>Lynxee consulting<\/b>\u2019s team is at your disposal to answer your questions.<\/p>\n<p style=\"text-align: justify\"><b>Contact us!<\/b> <a href=\"https:\/\/lynxee.consulting\/en\/contact\/\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/lynxee.consulting\/en\/contact\/<\/a><\/p>\n<p>&nbsp;<\/p>\n<h6>Photo credit: PublicDomainPictures\/pixabay<\/h6>\n","protected":false},"excerpt":{"rendered":"<p>On 24 February 2021, the European Commission has published a new guidance document (SANTE\/2020\/12830, Rev.1) on pesticide analytical methods for risk assessment and post-approval control and<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":9,"featured_media":4748,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[335,164,58],"class_list":["post-4752","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulation","tag-analytical-methods","tag-document-guide-en","tag-guidance-document"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.1.1 - 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