{"id":544424,"date":"2026-08-27T01:23:37","date_gmt":"2026-08-26T23:23:37","guid":{"rendered":"https:\/\/dev.phytocontrol.com\/uncategorized\/anses-opinion-review-of-the-relevance-of-s-metolachlor-metabolites-noa-413173-and-esa-in-drinking-water\/"},"modified":"2026-08-27T01:23:38","modified_gmt":"2026-08-26T23:23:38","slug":"anses-opinion-review-of-the-relevance-of-s-metolachlor-metabolites-noa-413173-and-esa-in-drinking-water","status":"publish","type":"post","link":"https:\/\/dev.phytocontrol.com\/en\/regulatory-watch\/anses-opinion-review-of-the-relevance-of-s-metolachlor-metabolites-noa-413173-and-esa-in-drinking-water\/","title":{"rendered":"ANSES opinion: review of the relevance of S-metolachlor metabolites NOA 413173 and ESA in drinking water"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><\/p>\n\n<p class=\"wp-block-paragraph\">On 30 September 2022, ANSES published two opinions on the review of the relevance of the S-metolachlor metabolites NOA 413173 and ESA in water intended for human consumption (EDCH).<\/p>\n\n<p class=\"wp-block-paragraph\"><strong><u>NOA<\/u><\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">As part of the ANSES opinion of 14 January 2021, the S-metolachlor metabolite NOA 413173 underwent an initial relevance assessment. This metabolite was classed as &#8220;relevant for drinking water&#8221; based on doubts regarding its genotoxic potential. This assessment was carried out while the European reassessment procedure for the parent active substance, S-metolachlor, was underway. This reassessment is still ongoing.<\/p>\n\n<p class=\"wp-block-paragraph\">In early 2021, Syngenta, the marketing authorisation holder for S-metolachlor, submitted two toxicity studies (28 and 90 days) as part of the European reassessment of the active substance.<\/p>\n\n<p class=\"wp-block-paragraph\">In April 2021, given the difficulties in supplying the population with water compliant with regulatory requirements for pesticides and their metabolites, the DGS asked ANSES to determine a maximum threshold value (VMAX) for the NOA 413173 metabolite. ANSES considered it necessary first to resolve doubts about the metabolite&#8217;s genotoxic potential, subject to new genotoxicity data being available. In February 2022, Syngenta submitted a new genotoxicity study to allow the relevance classification for this metabolite to be reviewed.<\/p>\n\n<p class=\"wp-block-paragraph\">Based on the results of the Ames test and the <em>in vitro<\/em> gene mutation test, the &#8220;Water&#8221; expert committee concluded there was <strong><u>no genotoxic effect<\/u><\/strong> from metolachlor NOA 413173 (SYN 547627).<\/p>\n\n<p class=\"wp-block-paragraph\">The relevance assessment for drinking water is therefore continuing.<\/p>\n\n<p class=\"wp-block-paragraph\">Based on data from European assessment reports, the new genotoxicity study submitted by the applicant, and supplementary literature research, and in accordance with the decision framework for determining relevance in drinking water, metolachlor NOA 413173 is considered a metabolite &#8220;not relevant for drinking water&#8221;.<\/p>\n\n<p class=\"wp-block-paragraph\"><strong><u>ESA<\/u><\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">As part of the opinion of 30 January 2019, the S-metolachlor metabolite ESA (CGA 354743) underwent an initial relevance assessment. This metabolite was classified as &#8220;relevant for drinking water&#8221;, given insufficient data on its &#8220;pesticidal&#8221; activity and the lack of robustness of certain data, which prevented any conclusion on its genotoxic potential.<\/p>\n\n<p class=\"wp-block-paragraph\">This assessment was carried out while the European reassessment procedure for the parent active substance, S-metolachlor, was underway. This is still ongoing.<\/p>\n\n<p class=\"wp-block-paragraph\">In 2020, additional data, particularly on the metabolite&#8217;s &#8220;pesticidal&#8221; activity and genotoxic potential, were submitted by Syngenta. In its opinion of 14 January 2021 (ANSES, 2021), ANSES concluded there was no &#8220;pesticidal&#8221; activity for the metabolite. However, it remained classified as &#8220;relevant for drinking water&#8221;, given equivocal test results regarding its genotoxic potential and shortcomings identified when reviewing the available studies, which still did not allow a firm conclusion on the matter.<\/p>\n\n<p class=\"wp-block-paragraph\">At the end of 2021, two new genotoxicity studies were submitted to ANSES by the notifier, to provide additional information on the metabolite&#8217;s genotoxic potential. Taking these new data into account, the DGS asked ANSES to reassess the relevance of the S-metolachlor metabolite ESA (CGA 354743).<\/p>\n\n<p class=\"wp-block-paragraph\">The &#8220;Water&#8221; expert committee concluded there was no genotoxic effect from metolachlor ESA (CGA 354743).<\/p>\n\n<p class=\"wp-block-paragraph\">The relevance assessment for drinking water is therefore continuing.<\/p>\n\n<p class=\"wp-block-paragraph\">Based on data from European assessment reports, the new genotoxicity studies submitted by the applicant, and supplementary literature research, and in accordance with the decision framework for determining relevance in drinking water, <strong>metolachlor ESA (CGA 354743) is considered a metabolite &#8220;not relevant for drinking water&#8221;.<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">Please note that Phytocontrol holds the national approval from the Ministry of Health for carrying out sampling and analyses for the sanitary control of water.<\/p>\n\n<p class=\"wp-block-paragraph\">We offer analysis of a wide range of pesticides and metabolites in your fresh water, natural mineral water and carbonated water. You will find the details of our accreditations in our COFRAC technical annex No. 1-6066.<\/p>\n\n<p class=\"wp-block-paragraph\">Need technical, regulatory or pricing information? Our customer service is available from 8am to 8pm, Monday to Friday, at <a href=\"tel:+33800900775\">+33 800 900 775<\/a> or <a href=\"mailto:service-clients@phytocontrol.com\">service-clients@phytocontrol.com<\/a><\/p>\n\n<p class=\"wp-block-paragraph\">And to stay up to date with all Phytocontrol news, join us on our <a rel=\"noreferrer noopener\" href=\"https:\/\/www.linkedin.com\/company\/laboratoire-phytocontrol\/\" target=\"_blank\">LinkedIn<\/a> page!<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 30 September 2022, ANSES published two opinions on the review of the relevance of&hellip;<\/p>\n","protected":false},"author":8,"featured_media":27985,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[181],"tags":[],"class_list":["post-544424","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory-watch"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.4 (Yoast SEO v28.5) - 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