{"id":49245,"date":"2014-05-19T15:58:56","date_gmt":"2014-05-19T19:58:56","guid":{"rendered":"http:\/\/www.farmchemicalsinternational.com\/?p=49245"},"modified":"2019-09-25T06:30:24","modified_gmt":"2019-09-25T10:30:24","slug":"unpredictability-rules-brazilian-pesticide-registrations","status":"publish","type":"post","link":"https:\/\/www.agribusinessglobal.com\/pt\/agrochemicals\/unpredictability-rules-brazilian-pesticide-registrations\/","title":{"rendered":"Imprevisibilidade rege registros de agrot\u00f3xicos no Brasil"},"content":{"rendered":"<p>Os desafios para entrar no mercado de pesticidas mais atraente e lucrativo do mundo \u2013 estimado em $11,6 bilh\u00f5es em 2013 \u2013 n\u00e3o s\u00e3o nenhuma surpresa. Alguns deles s\u00e3o imposs\u00edveis de superar. De fato, o sistema de registro de pesticidas no Brasil \u00e9 um dos mais complexos do mundo. Para come\u00e7ar, h\u00e1 tr\u00eas ag\u00eancias federais envolvidas no registro, cada uma com suas pr\u00f3prias regras e procedimentos internos. Elas s\u00e3o: MAPA (Minist\u00e9rio da Agricultura); ANVISA (Minist\u00e9rio da Sa\u00fade) e IBAMA (Minist\u00e9rio do Meio Ambiente), al\u00e9m dos registros estaduais.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.farmchemicalsinternational.com\/wp-content\/uploads\/2014\/05\/Reg-Blk-Dia.jpg\" alt=\"Brazil registration\" width=\"700\" height=\"525\" class=\"alignleft size-full wp-image-49246\" srcset=\"https:\/\/www.agribusinessglobal.com\/wp-content\/uploads\/2014\/05\/Reg-Blk-Dia.jpg 700w, https:\/\/www.agribusinessglobal.com\/wp-content\/uploads\/2014\/05\/Reg-Blk-Dia-300x225.jpg 300w, https:\/\/www.agribusinessglobal.com\/wp-content\/uploads\/2014\/05\/Reg-Blk-Dia-330x247.jpg 330w, https:\/\/www.agribusinessglobal.com\/wp-content\/uploads\/2014\/05\/Reg-Blk-Dia-96x72.jpg 96w, https:\/\/www.agribusinessglobal.com\/wp-content\/uploads\/2014\/05\/Reg-Blk-Dia-480x360.jpg 480w, https:\/\/www.agribusinessglobal.com\/wp-content\/uploads\/2014\/05\/Reg-Blk-Dia-85x63.jpg 85w, https:\/\/www.agribusinessglobal.com\/wp-content\/uploads\/2014\/05\/Reg-Blk-Dia-150x112.jpg 150w\" sizes=\"auto, (max-width: 700px) 100vw, 700px\" \/><\/p>\n<p>Desde que a nova regulamenta\u00e7\u00e3o sobre registro de equival\u00eancia foi aprovada no final de 2006, quase todos os principais fabricantes de pesticidas do mundo, incluindo novas empresas locais, come\u00e7aram a correr para solicitar registros para acessar rapidamente o mercado. <\/p>\n<p>Desde ent\u00e3o, foram aprovados aproximadamente 250 formula\u00e7\u00f5es e 320 registros t\u00e9cnicos de produtos com base em equival\u00eancia. <\/p>\n<p>At\u00e9 2011, a avalia\u00e7\u00e3o dos registros levava de 2 a 2,5 anos para ser conclu\u00edda a partir do momento da submiss\u00e3o. No entanto, ap\u00f3s investiga\u00e7\u00f5es internas na ANVISA em 2012, quando dois gerentes foram demitidos, o tempo de espera aumentou drasticamente. N\u00e3o apenas as avalia\u00e7\u00f5es ficaram lentas, mas o n\u00famero de submiss\u00f5es tamb\u00e9m aumentou consideravelmente, aumentando o atraso.<\/p>\n<div id=\"attachment_49247\" style=\"width: 730px\" class=\"wp-caption alignleft\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-49247\" src=\"https:\/\/www.farmchemicalsinternational.com\/wp-content\/uploads\/2014\/05\/Reg-App.jpg\" alt=\"Source: Ministry of Agriculture, Jan. 2014\" width=\"720\" height=\"229\" class=\"size-full wp-image-49247\" srcset=\"https:\/\/www.agribusinessglobal.com\/wp-content\/uploads\/2014\/05\/Reg-App.jpg 720w, https:\/\/www.agribusinessglobal.com\/wp-content\/uploads\/2014\/05\/Reg-App-300x95.jpg 300w, https:\/\/www.agribusinessglobal.com\/wp-content\/uploads\/2014\/05\/Reg-App-330x104.jpg 330w, https:\/\/www.agribusinessglobal.com\/wp-content\/uploads\/2014\/05\/Reg-App-128x40.jpg 128w, https:\/\/www.agribusinessglobal.com\/wp-content\/uploads\/2014\/05\/Reg-App-640x203.jpg 640w, https:\/\/www.agribusinessglobal.com\/wp-content\/uploads\/2014\/05\/Reg-App-85x27.jpg 85w, https:\/\/www.agribusinessglobal.com\/wp-content\/uploads\/2014\/05\/Reg-App-150x47.jpg 150w\" sizes=\"auto, (max-width: 720px) 100vw, 720px\" \/><p id=\"caption-attachment-49247\" class=\"wp-caption-text\">Fonte: Minist\u00e9rio da Agricultura, janeiro de 2014<\/p><\/div>\n<p>Para os pedidos de registro de hoje, de acordo com estimativas pessimistas, o processo de avalia\u00e7\u00e3o provavelmente levar\u00e1 de 7 a 11 anos. No entanto, \u00e9 razo\u00e1vel sugerir que isso pode acontecer em apenas 3 a 4 anos a partir do momento do pedido. No entanto, h\u00e1 alguns casos registrados que foram aprovados em menos de 12 meses.<\/p>\n<div id=\"attachment_49248\" style=\"width: 850px\" class=\"wp-caption alignleft\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-49248\" src=\"https:\/\/www.farmchemicalsinternational.com\/wp-content\/uploads\/2014\/05\/Num-Sub-Eq.jpg\" alt=\"Source: ANVISA, Jan. 2014\" width=\"840\" height=\"179\" class=\"size-full wp-image-49248\" srcset=\"https:\/\/www.agribusinessglobal.com\/wp-content\/uploads\/2014\/05\/Num-Sub-Eq.jpg 840w, https:\/\/www.agribusinessglobal.com\/wp-content\/uploads\/2014\/05\/Num-Sub-Eq-300x63.jpg 300w, https:\/\/www.agribusinessglobal.com\/wp-content\/uploads\/2014\/05\/Num-Sub-Eq-330x70.jpg 330w, https:\/\/www.agribusinessglobal.com\/wp-content\/uploads\/2014\/05\/Num-Sub-Eq-128x27.jpg 128w, https:\/\/www.agribusinessglobal.com\/wp-content\/uploads\/2014\/05\/Num-Sub-Eq-640x136.jpg 640w, https:\/\/www.agribusinessglobal.com\/wp-content\/uploads\/2014\/05\/Num-Sub-Eq-85x18.jpg 85w, https:\/\/www.agribusinessglobal.com\/wp-content\/uploads\/2014\/05\/Num-Sub-Eq-150x31.jpg 150w\" sizes=\"auto, (max-width: 840px) 100vw, 840px\" \/><p id=\"caption-attachment-49248\" class=\"wp-caption-text\">Fonte: ANVISA, jan. 2014<\/p><\/div>\n<p>Notas:<br \/>\nPTE: produto t\u00e9cnico baseado em equival\u00eancia<br \/>\nPT: produto t\u00e9cnico n\u00e3o baseado em equival\u00eancia<br \/>\nPF: formula\u00e7\u00e3o n\u00e3o baseada em equival\u00eancia<br \/>\nPF\/PTE: formula\u00e7\u00e3o vinculada a um registro t\u00e9cnico de produto com base na equival\u00eancia<br \/>\nPM: pr\u00e9-mistura<\/p>\n<p>Incertezas quanto \u00e0s regulamenta\u00e7\u00f5es diminu\u00edram a confian\u00e7a que as empresas interessadas t\u00eam neste mercado e muitas vezes as fizeram adiar seus planos para o futuro. N\u00e3o obstante o n\u00famero de novos participantes, os envios de registro est\u00e3o definitivamente aumentando. <\/p>\n<p><strong>Quest\u00f5es Cr\u00edticas<\/strong><\/p>\n<p>\u2013 Conclus\u00f5es da avalia\u00e7\u00e3o do registro: imprevisibilidade e atrasos.<br \/>\n\u2013 Crit\u00e9rios pouco claros para registro de produtos e aus\u00eancia de processos padronizados.<br \/>\n\u2013 Recentemente, as autoridades reguladoras deliberaram que os envios de registro em andamento n\u00e3o podem ser transferidos e os nomes comerciais n\u00e3o podem ser alterados at\u00e9 a aprova\u00e7\u00e3o.<br \/>\n\u2013 ANVISA e IBAMA, duas das tr\u00eas ag\u00eancias envolvidas no registro, consideram que um produto n\u00e3o \u00e9 eleg\u00edvel para registro quando j\u00e1 est\u00e1 registrado um que representa um risco ambiental\/toxicol\u00f3gico maior. Esse entendimento foi por v\u00e1rios anos apenas para novos ingredientes ativos.<br \/>\n\u2013 EUP (permiss\u00e3o de uso experimental): prazo m\u00e1ximo de validade de 6 anos. Muito curto considerando que avalia\u00e7\u00f5es de registro podem levar de 4 a 5 anos.<br \/>\n\u2013 Aprova\u00e7\u00f5es de EUP com erros: as corre\u00e7\u00f5es podem levar de 2 a 6 meses.<br \/>\n\u2013 Amostra de lote para teste toxicol\u00f3gico (6 embalagens e 2 de mutagenicidade): deve ser realizada com lote escolhido pela ANVISA.<\/p>\n<p>Um projeto para melhorar o Decreto regulat\u00f3rio de registro 4074 com o objetivo de acelerar as avalia\u00e7\u00f5es de registro foi discutido em 2013 com os principais participantes do agroneg\u00f3cio, incluindo ag\u00eancias reguladoras. Como esperado, foi descontinuado. Assim, para o ano atual, com a Copa do Mundo no Brasil e elei\u00e7\u00f5es presidenciais logo depois, a perspectiva de mudan\u00e7a da situa\u00e7\u00e3o atual \u00e9 desanimadora.<\/p>\n<p>Levando em conta a imprevisibilidade e os atrasos nas conclus\u00f5es da avalia\u00e7\u00e3o do registro, algumas empresas est\u00e3o considerando a possibilidade de processar ag\u00eancias reguladoras. De fato, h\u00e1 casos registrados em que requerentes de registro ganharam a\u00e7\u00f5es judiciais contra ag\u00eancias. Certamente a decis\u00e3o de processar uma ag\u00eancia governamental deve ser muito bem pensada, pois nenhuma empresa tem como objetivo contrariar o estabelecimento. <\/p>\n<p>Por falta de m\u00e3o de obra, as ag\u00eancias reguladoras est\u00e3o restritas a prazos. Assim, no curto prazo, a perspectiva n\u00e3o \u00e9 muito otimista, pois a fila de submiss\u00f5es de registro est\u00e1 aumentando, enquanto as avalia\u00e7\u00f5es n\u00e3o est\u00e3o acompanhando o ritmo. <\/p>\n<p>No entanto, mais e mais jogadores est\u00e3o dispostos a correr riscos neste caminho muito incerto para o maior mercado global de pesticidas \u2013 onde 26% de submiss\u00f5es para produtos t\u00e9cnicos s\u00e3o rejeitadas. Para aqueles que superam essa barreira de entrada, a guerra ainda n\u00e3o foi vencida. Al\u00e9m disso, muitas outras batalhas ainda precisam ser vencidas. Mas, por meio de uma boa gest\u00e3o, \u00e9 razo\u00e1vel que eles vislumbrem um crescimento sustent\u00e1vel nos pr\u00f3ximos 10 a 20 anos.<\/p>","protected":false},"excerpt":{"rendered":"<p>Cada vez mais participantes est\u00e3o dispostos a correr riscos em um caminho muito incerto rumo ao maior mercado global de pesticidas.<\/p>","protected":false},"author":72,"featured_media":48516,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[24,4,26,22,18,19,20],"tags":[],"class_list":["post-49245","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-adjuvants","category-agrochemicals","category-americas","category-biopesticides","category-fungicides","category-herbicides","category-insecticides"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ 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