{"id":3051,"date":"2018-11-19T15:08:53","date_gmt":"2018-11-19T15:08:53","guid":{"rendered":"https:\/\/lynxee.consulting\/?p=3051\/"},"modified":"2023-01-26T13:50:19","modified_gmt":"2023-01-26T13:50:19","slug":"europe-adoption-of-timelines-for-additional-data-on-ed-for-air-iii-active-substances","status":"publish","type":"post","link":"https:\/\/lynxee.consulting\/en\/europe-adoption-of-timelines-for-additional-data-on-ed-for-air-iii-active-substances\/","title":{"rendered":"EUROPE: Adoption of Timelines for Additional Data on ED for AIR III Active Substances"},"content":{"rendered":"<p style=\"text-align: justify\">As adopted by the Commission, the new scientific criteria to identify endocrine disruptors (ED) (<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32018R0605&amp;from=EN\" target=\"_blank\" rel=\"noopener noreferrer\">Reg. (EU) 2018\/605<\/a>) and the associated EFSA\/ECHA guidance (<a href=\"https:\/\/efsa.onlinelibrary.wiley.com\/doi\/epdf\/10.2903\/j.efsa.2018.5311\" target=\"_blank\" rel=\"noopener noreferrer\">EFSA Journal 2018;16(6):5311<\/a>) are applicable for the assessment of all active substances (AS) since 10 November 2018, including the AS being under renewal (<a href=\"https:\/\/ec.europa.eu\/food\/plant\/pesticides\/approval_active_substances\/approval_renewal_en\" target=\"_blank\" rel=\"noopener noreferrer\">AIR III renewal programm<\/a>) for which no draft regulation has been voted by the Committee.<\/p>\n<p style=\"text-align: justify\">For those AS still being under renewal by 10 November 2018, the <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32018R1659&amp;qid=1543240359830&amp;from=EN\" target=\"_blank\" rel=\"noopener noreferrer\"><b>Reg. (EU) No 2018\/1659<\/b><\/a>, recently adopted, amends <a href=\"https:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=OJ:L:2012:252:0026:0032:EN:PDF\" target=\"_blank\" rel=\"noopener noreferrer\">Reg. (EU) No 844\/2012<\/a> to <b>define new timelines specifically dedicated to the submission and assessment of complementary data as regards endocrine disruption<\/b>. A summary of the new timelines is presented below.<\/p>\n<p style=\"text-align: justify\"><span style=\"text-decoration: underline\">AS for which the new EFSA conclusion is not adopted by 10 November 2018:<\/span><\/p>\n<ul>\n<li style=\"text-align: justify\">If <b>additional data are deemed necessary<\/b> by Member States (MS) and EFSA to assess if the ED criteria are met: data expected are detailed and justified, and a period between <b>3 and 30 months is set for the submission<\/b> by the applicant (depending on the type of data required).<\/li>\n<li style=\"text-align: justify\">If <b>no<\/b> <b>additional data are deemed necessary<\/b> by MS and EFSA to assess if the ED criteria are met: after having been informed, the <b>applicant may submit additional data<\/b> as regards ED properties of the AS <b>within 3 months<\/b>.<\/li>\n<li style=\"text-align: justify\">For both situations described above, the <b>applicant may also provide supporting information as regards the potential derogation<\/b> for ED active substances according to Article 4(7) of <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32009R1107&amp;from=FR\" target=\"_blank\" rel=\"noopener noreferrer\">Reg. (EC) No 1107\/2009<\/a> within the respective period set.<\/li>\n<li style=\"text-align: justify\">After the submission of data by the applicant, the <b>RMS shall produce a revised renewal assessment report <\/b>(RAR)<b> within 90 days<\/b>. Then, after the submission of the revised RAR, <b>a conclusion on the AS shall be adopted by EFSA within 120 days<\/b>. This period includes a consultation of MS and of the applicant on the revised RAR.<\/li>\n<li style=\"text-align: justify\"><b>Non-requested data <\/b>or <b>data submitted<\/b> by the applicant <b>after the expiry of the period<\/b> <b>set<\/b> for its submission will <b>not<\/b> be <b>considered<\/b>.<\/li>\n<\/ul>\n<p style=\"text-align: justify\"><span style=\"text-decoration: underline\">AS for which the new EFSA conclusion is adopted by 10 November 2018 (but no draft Regulation has been voted by the Committee):<\/span><\/p>\n<ul>\n<li style=\"text-align: justify\">The <b>Commission may consider that additional information as regards endocrine disruption are needed<\/b> to apply the adopted criteria and hence request a revision of the assessment by EFSA within a reasonable time period.<\/li>\n<li style=\"text-align: justify\">In the case of a revision request,<b> same conditions and timelines as presented<\/b> <b>above<\/b> (<em>AS for which the new EFSA conclusion is not adopted by 10 November 2018<\/em>) apply.<\/li>\n<li style=\"text-align: justify\"><b>If no data are submitted by the applicant<\/b>, <b>EFSA shall conclude the assessment within 30 days<\/b>.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><b>To download: <\/b><\/p>\n<p style=\"text-align: justify\"><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32018R1659&amp;qid=1543240359830&amp;from=EN\" target=\"_blank\" rel=\"noopener noreferrer\">Regulation (EU) No 2018\/1659<\/a> of 7 November 2018 amending Reg. (EU) No 844\/2012 in view of the scientific criteria for the determination of endocrine disrupting properties introduced by Reg. (EU) No 2018\/605.<\/p>\n<p>&nbsp;<\/p>\n<p><b>See also our previous articles: <\/b><\/p>\n<p style=\"text-align: justify\"><a href=\"https:\/\/lynxee.consulting\/en\/europe-com-availability-and-applicability-of-the-efsaecha-guidance-on-identifying-endocrine-disruptors\/\" target=\"_blank\" rel=\"noopener noreferrer\">EUROPE \u2013 COM: Availability and applicability of the EFSA\/ECHA guidance on identifying endocrine disruptors<\/a><\/p>\n<p>&nbsp;<\/p>\n<p><b>Lynxee consulting<\/b>\u2019s team is at your disposal to answer your questions.<\/p>\n<p><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<p>&nbsp;<\/p>\n<h6>Photo credit: Bellahu123\/pixabay<\/h6>\n","protected":false},"excerpt":{"rendered":"<p>As adopted by the Commission, the new scientific criteria to identify endocrine disruptors (ED) (Reg. (EU) 2018\/605) and the associated EFSA\/ECHA guidance (EFSA Journal 2018;16(6):5311) are<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":7,"featured_media":6211,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33,36],"tags":[65,201,118,181],"class_list":["post-3051","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-regulation","tag-11072009-en","tag-air-3-en","tag-endocrine-disruptors","tag-perturbateurs-endocriniens-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.1.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EUROPE: Adoption of Timelines for Additional Data on ED for AIR III Active Substances - Lynxee consulting<\/title>\n<meta name=\"description\" content=\"As adopted by the Commission, the new scientific criteria to identify endocrine disruptors (ED) (Reg. 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