{"id":3918,"date":"2020-02-07T09:10:47","date_gmt":"2020-02-07T09:10:47","guid":{"rendered":"https:\/\/lynxee.consulting\/?p=3918"},"modified":"2023-01-26T16:06:59","modified_gmt":"2023-01-26T16:06:59","slug":"europe-synchronisation-of-the-renewal-procedure-for-active-substances-with-the-harmonised-classification-process","status":"publish","type":"post","link":"https:\/\/lynxee.consulting\/en\/europe-synchronisation-of-the-renewal-procedure-for-active-substances-with-the-harmonised-classification-process\/","title":{"rendered":"EUROPE: Synchronisation of the renewal procedure for active substances with the harmonised classification process"},"content":{"rendered":"<p style=\"text-align: justify\"><span style=\"font-weight: 400\">Commission Implementing Regulation (EU) 2020\/103 of 17 January 2020 amends Regulation (EU) No 844\/2012 as regards the provisions necessary for the implementation of the renewal procedure for active substances under Regulation (EC) No 1107\/2009.<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">A 3-month additional time is allowed to the rapporteur Member State for preparing the draft renewal assessment report of the active substance (RAR) and the dossier of harmonised classification and labelling submitted to the European Chemicals Agency (ECHA). In consequence, the European Food Safety Authority (EFSA) will also have these 3 additional months for preparing its conclusion. In return, the period allowed to the applicants will be reduced by 3 months between the submission of the application of renewal and the submission of the supplementary dossiers.<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">Thus, supplementary dossiers should be submitted no later than 33 months, instead of 30 months, before the expiry of the approval.\u00a0<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">The rapporteur Member State will have 13 months, instead of 12 months, to prepare and submit the renewal assessment report (RAR) to the Commission and to EFSA. Additional information requests to the applicants and consultation of EFSA and other member states do not lead to an extension of the period of 13 months.<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">The rapporteur Member State should submit at the latest at the time of submission a proposal to ECHA to obtain an opinion on harmonised classification of the active substance at least for the following hazard classes:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">explosives,<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">acute toxicity,\u00a0<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">skin corrosion\/irritation,\u00a0<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">serious eye damage\/eye irritation,<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">respiratory or skin sensitisation,<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">germ cell mutagenicity,<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">carcinogenicity,<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">reproductive toxicity,<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">specific target organ toxicity, single exposure,<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">specific target organ toxicity, repeated exposure,<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">hazardous to the aquatic environment. <\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">The Committee for Risk Assessment from ECHA should adopt the opinion within 13 months from the submission of the dossier.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">These new implementations apply to renewal procedures of active substances for which the approval period expires on or after 13 May 2023, excepted the substances for which supplementary dossiers have already been submitted before 17 January 2020.<\/span><\/p>\n<p><span style=\"font-weight: 400\">\u00a0<\/span><\/p>\n<p><b>To download:\u00a0<\/b><\/p>\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32020R0103&amp;from=EN\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400\">COMMISSION IMPLEMENTING REGULATION (EU) 2020\/103 of 17 January 2020 amending Implementing Regulation (EU) No 844\/2012 as regards the harmonised classification of active substances<\/span><\/a><\/p>\n<p>&nbsp;<\/p>\n<p><b>Lynxee consulting<\/b><span style=\"font-weight: 400\">\u2019s team is at your disposal to answer your questions.<\/span><\/p>\n<p><b>Contact us!<\/b> <a href=\"https:\/\/lynxee.consulting\/en\/contact\/\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400\">https:\/\/lynxee.consulting\/en\/contact\/<\/span><\/a><\/p>\n<p>&nbsp;<\/p>\n<h6>Photo credit: ptra\/pixabay<\/h6>\n","protected":false},"excerpt":{"rendered":"<p>Commission Implementing Regulation (EU) 2020\/103 of 17 January 2020 amends Regulation (EU) No 844\/2012 as regards the provisions necessary for the implementation of the renewal procedure<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":9,"featured_media":3917,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[312,67,290,98,151],"class_list":["post-3918","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulation","tag-844-2012-en","tag-clp-en","tag-clp-en-2","tag-renewal","tag-renouvellement-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.1.1 - 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