{"id":5869,"date":"2022-10-31T03:12:24","date_gmt":"2022-10-31T03:12:24","guid":{"rendered":"https:\/\/lynxee.consulting\/?p=5869"},"modified":"2023-01-26T14:44:44","modified_gmt":"2023-01-26T14:44:44","slug":"europe-com-public-consultation-draft-regulation-for-the-identification-of-unacceptable-co-formulants","status":"publish","type":"post","link":"https:\/\/lynxee.consulting\/en\/europe-com-public-consultation-draft-regulation-for-the-identification-of-unacceptable-co-formulants\/","title":{"rendered":"EUROPE &#8211; COM &#8211; Public Consultation : Draft regulation for the identification of unacceptable co-formulants"},"content":{"rendered":"<p style=\"text-align: justify\"><span style=\"font-weight: 400\">The E<\/span><span style=\"font-weight: 400\">uropean commission has launched a public consultation<\/span><b> from 21 October 2022 to 18 <\/b><b>N<\/b><b>ovember 2022<\/b><span style=\"font-weight: 400\"> on a draft implementing regulation to detail the <\/span><b>rules and criteria for the identification of unacceptable co-formulants for inclusion in plant protection products <\/b><span style=\"font-weight: 400\">(PPP).<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">In addition to setting out the criteria for the identification of unacceptable co-formulants, detailed below, the draft regulation presents how Member State (MS) will <\/span><b>assess co-formulants <\/b><span style=\"font-weight: 400\">and<\/span><b> notify those that appear unacceptable<\/b><span style=\"font-weight: 400\">. The <\/span><b>content of the notification report<\/b><span style=\"font-weight: 400\"> for a co-formulant identified as unacceptable and the <\/span><b>procedure for its publication by the Commission<\/b><span style=\"font-weight: 400\"> is described. The <\/span><b>procedure for inclusion of the co-formulant in Annex III to <\/b><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32009R1107&amp;from=fr\" target=\"_blank\" rel=\"noopener\"><b>Regulation (EC) No 1107\/2009<\/b><\/a> <span style=\"font-weight: 400\">is also detailed.<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">The annex of the regulation lists the 10 criteria that may lead to the identification of a co-formulant as\u00a0 unacceptable :<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;text-align: justify\"><span style=\"font-weight: 400\">The co-formulant is <\/span><b>classified as mutagen category 1A or 1B<\/b><span style=\"font-weight: 400\"> (1), <\/span><b>carcinogen category 1A or 1B <\/b><span style=\"font-weight: 400\">(2) or\u00a0 <\/span><b>toxic for reproduction category 1A or 1B<\/b><span style=\"font-weight: 400\"> (3) in Part 3 of Annex VI to <\/span><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32008R1272&amp;from=FR\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">Regulation (EC) No 1272\/2008<\/span><\/a><span style=\"font-weight: 400\">.<\/span><\/li>\n<\/ul>\n<ul>\n<li style=\"font-weight: 400;text-align: justify\"><span style=\"font-weight: 400\">The co-formulant is<\/span><b> listed in Annexes I to V <\/b><span style=\"font-weight: 400\">to<\/span><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32019R1021&amp;from=en\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\"> Regulation (EU) 2019\/1021 <\/span><\/a><span style=\"font-weight: 400\">(4).<\/span><\/li>\n<li style=\"font-weight: 400;text-align: justify\"><span style=\"font-weight: 400\">The co-formulant is included in the list referred to in Article 59(1)<\/span> <span style=\"font-weight: 400\">of <\/span><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:02006R1907-20140410&amp;from=FR\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">Regulation (EC) No 1907\/2006<\/span><\/a><span style=\"font-weight: 400\">,<\/span> <b>identified as persistent, bioaccumulative and toxic <\/b><span style=\"font-weight: 400\">(Article 57, point (d)),<\/span><b> very persistent and very bioaccumulative <\/b><span style=\"font-weight: 400\">(Article 57, point (<\/span><span style=\"font-weight: 400\">e))<\/span> <span style=\"font-weight: 400\">or of<\/span><b> v<\/b><b>ery high concern<\/b><span style=\"font-weight: 400\">\u00a0 due to endocrine disrupting properties (Article 57, point (f)) (5).<\/span><\/li>\n<li style=\"font-weight: 400;text-align: justify\"><span style=\"font-weight: 400\">The co-formulant is<\/span><b> identified as having endocrine-disrupting properties<\/b><span style=\"font-weight: 400\"> in accordance with <\/span><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32012R0528&amp;from=fr\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">Regulation (EU) No 528\/2012<\/span><\/a><span style=\"font-weight: 400\"> (6).<\/span><\/li>\n<li style=\"font-weight: 400;text-align: justify\"><span style=\"font-weight: 400\">A decision was adopted <\/span><b>not to approve the co-formulant as an active substance for product-type 6<\/b><span style=\"font-weight: 400\"> (7) or to <\/span><b>approve it as an active substance with restrictions that are relevant for PPP uses <\/b><span style=\"font-weight: 400\">(8) under <\/span><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32012R0528&amp;from=fr\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">Regulation (EU) No 528\/2012<\/span><\/a><span style=\"font-weight: 400\">.<\/span><\/li>\n<li style=\"font-weight: 400;text-align: justify\"><span style=\"font-weight: 400\">The use of the <\/span><b>substance as a co-formulant<\/b><span style=\"font-weight: 400\"> is included in Annex XVII to <\/span><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:02006R1907-20140410&amp;from=FR\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">Regulation (EC) No 1907\/2006<\/span><\/a><span style=\"font-weight: 400\"> and<\/span><b> restricted for the use in PPP<\/b><span style=\"font-weight: 400\"> (9).<\/span><\/li>\n<li style=\"font-weight: 400;text-align: justify\"><span style=\"font-weight: 400\">The co-formulant does not fall under any of the points (1) to (9), but, having regard to realistic conditions of use and good plant protection practice,<\/span><b> it does not comply with one of the criteria for the approval of active substances<\/b><span style=\"font-weight: 400\"> as provided for in Annex II to <\/span><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32009R1107&amp;from=fr\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">Regulation (EC) No 1107\/2009<\/span><\/a><span style=\"font-weight: 400\">, <\/span><b>when used as a co-formulant in a PPP <\/b><span style=\"font-weight: 400\">(10).<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">Interested parties are invited to submit comments on the draft document <\/span><i><span style=\"font-weight: 400\">via <\/span><\/i><span style=\"font-weight: 400\">the <\/span><a href=\"https:\/\/ec.europa.eu\/info\/law\/better-regulation\/have-your-say\/initiatives\/13416-Plant-protection-products-pesticides-identification-of-unacceptable-co-formulants_en\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">dedicated consultation page<\/span><\/a><span style=\"font-weight: 400\">. The adoption of the regulation by the Commission is planned for the fourth quarter 2022.<\/span><\/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\/info\/law\/better-regulation\/have-your-say\/initiatives\/13416-Produits-phytopharmaceutiques-pesticides-identification-des-coformulants-inacceptables_fr\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">Draft implementing regulation <\/span><\/a><span style=\"font-weight: 400\">and its <\/span><a href=\"https:\/\/ec.europa.eu\/info\/law\/better-regulation\/have-your-say\/initiatives\/13416-Produits-phytopharmaceutiques-pesticides-identification-des-coformulants-inacceptables_fr\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">Annex <\/span><\/a><span style=\"font-weight: 400\">for the establishment of harmonised criteria and procedures for identifying unacceptable co-formulants<\/span><\/p>\n<p style=\"text-align: justify\"><b>See also our previous articles:\u00a0<\/b><\/p>\n<p style=\"text-align: justify\"><a href=\"https:\/\/lynxee.consulting\/en\/france-anses-implementation-of-the-regulatory-provisions-on-banned-co-formulants\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">FRANCE \u2013 ANSES: Implementation of the regulatory provisions on banned co-formulants<\/span><\/a><\/p>\n<p style=\"text-align: justify\"><a href=\"https:\/\/lynxee.consulting\/en\/europe-com-publication-of-the-list-of-co-formulants-banned-in-ppp\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">EUROPE \u2013 COM: Publication of the list of co-formulants banned in PPP<\/span><\/a><\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify\"><b>Lynxee consulting<\/b><span style=\"font-weight: 400\">\u2019s team is at your disposal to answer your questions.<\/span><\/p>\n<p style=\"text-align: justify\"><b>Contact us!<\/b> <a href=\"http:\/\/lynxee.consulting\/en\/contact\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">http:\/\/lynxee.consulting\/en\/contact\/<\/span><\/a><\/p>\n<p>&nbsp;<\/p>\n<h6><span style=\"font-weight: 400\">Photo credit : PublicDomainPictures<\/span><span style=\"font-weight: 400\">\/pixabay<\/span><\/h6>\n","protected":false},"excerpt":{"rendered":"<p>The European commission has launched a public consultation from 21 October 2022 to 18 November 2022 on a draft implementing regulation to detail the rules and<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":11,"featured_media":5867,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[403,404,402,405],"class_list":["post-5869","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulation","tag-co-formulant-en","tag-commission-en","tag-draft","tag-ppp-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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