{"id":134790,"date":"2026-05-26T16:06:37","date_gmt":"2026-05-26T20:06:37","guid":{"rendered":"https:\/\/www.agribusinessglobal.com\/?p=134790"},"modified":"2026-05-26T16:06:37","modified_gmt":"2026-05-26T20:06:37","slug":"ecca-warns-current-food-and-feed-safety-simplification-omnibus-needs-targeted-amendments-to-deliver-on-eu-wide-data-protection","status":"publish","type":"post","link":"https:\/\/www.agribusinessglobal.com\/pt\/markets\/europe\/ecca-warns-current-food-and-feed-safety-simplification-omnibus-needs-targeted-amendments-to-deliver-on-eu-wide-data-protection\/","title":{"rendered":"A CECA alerta que o atual Regulamento Geral de Simplifica\u00e7\u00e3o da Seguran\u00e7a Alimentar e dos Alimentos para Animais necessita de altera\u00e7\u00f5es espec\u00edficas para garantir a prote\u00e7\u00e3o de dados em toda a UE."},"content":{"rendered":"

O Associa\u00e7\u00e3o Europeia de Cuidados com as Culturas (ECCA)<\/a>, A [nome da entidade representativa da ind\u00fastria de prote\u00e7\u00e3o de plantas p\u00f3s-patente na Europa] instou os legisladores da UE a introduzirem altera\u00e7\u00f5es espec\u00edficas \u00e0 proposta de Simplifica\u00e7\u00e3o da Seguran\u00e7a Alimentar e de Alimentos para Animais (Food and Feed Safety Simplification Omnibus) para garantir que o quadro revisto de prote\u00e7\u00e3o de dados ao abrigo do Regulamento (CE) n.\u00ba 1107\/2009 proporcione seguran\u00e7a jur\u00eddica, concorr\u00eancia leal e maior disponibilidade de produtos em toda a Uni\u00e3o Europeia.<\/p>\n

A ECCA apoia amplamente o esp\u00edrito e os objetivos da proposta Omnibus. Em particular, a associa\u00e7\u00e3o sa\u00fada a proposta da Comiss\u00e3o Europeia de introduzir a sincroniza\u00e7\u00e3o dos per\u00edodos de prote\u00e7\u00e3o de dados em toda a UE como um passo crucial para um quadro regulamentar mais coerente e previs\u00edvel.<\/p>\n

No entanto, a ECCA alerta que, sem altera\u00e7\u00f5es espec\u00edficas, o sistema revisto pode n\u00e3o conseguir resolver completamente a incerteza jur\u00eddica existente e poder\u00e1, involuntariamente, permitir que a prote\u00e7\u00e3o de dados dure, na pr\u00e1tica, um per\u00edodo significativamente maior do que o pretendido pelo legislador.<\/p>\n

\u201cA proposta Omnibus representa uma oportunidade importante e bem-vinda para modernizar o quadro de prote\u00e7\u00e3o de dados para produtos fitofarmac\u00eauticos\u201d, afirmou Paolo Marchesini, Diretor-Geral da ECCA. \u201cNo entanto, para alcan\u00e7ar plenamente os benef\u00edcios pretendidos, o texto final deve incluir gatilhos legais claros e objetivos, salvaguardas contra extens\u00f5es n\u00e3o intencionais da prote\u00e7\u00e3o e ferramentas de implementa\u00e7\u00e3o vi\u00e1veis a n\u00edvel da UE.\u201d<\/p>\n

Principais quest\u00f5es regulat\u00f3rias a serem abordadas<\/h2>\n

No atual regime fragmentado de prote\u00e7\u00e3o de dados, as empresas p\u00f3s-patente enfrentam incerteza jur\u00eddica, encargos administrativos e distor\u00e7\u00f5es no mercado interno. A ECCA estima que a prote\u00e7\u00e3o de dados pouco clara ou artificialmente prolongada gera cerca de \u20ac 14,8 milh\u00f5es por ano em despesas desnecess\u00e1rias apenas para os seus membros.<\/p>\n

Uma preocupa\u00e7\u00e3o priorit\u00e1ria \u00e9 o risco de que os dados de renova\u00e7\u00e3o da subst\u00e2ncia ativa possam beneficiar de uma prote\u00e7\u00e3o de facto de at\u00e9 10 anos, em vez dos 30 meses previstos, quando esses dados s\u00e3o utilizados pela primeira vez em autoriza\u00e7\u00f5es de novos produtos. A CECA refere-se a este efeito indesejado como o "truque dos 10 anos".<\/p>\n

Caso n\u00e3o seja resolvido, este problema poder\u00e1 comprometer o pr\u00f3prio objetivo da harmoniza\u00e7\u00e3o em toda a UE, atrasando a concorr\u00eancia, aumentando os custos e reduzindo a previsibilidade jur\u00eddica em toda a Uni\u00e3o Europeia.<\/p>\n

\u201cA prote\u00e7\u00e3o de dados deve refletir a inten\u00e7\u00e3o do legislador, e n\u00e3o o cronograma dos procedimentos administrativos subsequentes\u201d, acrescentou Marchesini. \u201cSe os dados de renova\u00e7\u00e3o forem protegidos por um per\u00edodo substancialmente maior do que o previsto, o sistema corre o risco de atrasar a entrada no mercado de produtos p\u00f3s-patente e de enfraquecer o funcionamento eficaz do mercado interno.\u201d<\/p>\n

Uma corre\u00e7\u00e3o precisa ao seu alcance.<\/h2>\n

A CECA sublinha que a quest\u00e3o pode ser abordada no \u00e2mbito do atual processo legislativo sem alterar a dire\u00e7\u00e3o geral da proposta da Comiss\u00e3o.<\/p>\n

Em particular, a CECA apela a:<\/p>\n

    \n
  • salvaguardas expl\u00edcitas no Artigo 59 para garantir que a depend\u00eancia posterior dos dados de renova\u00e7\u00e3o da subst\u00e2ncia ativa n\u00e3o gere prote\u00e7\u00e3o estendida al\u00e9m da inten\u00e7\u00e3o do legislador;<\/li>\n
  • um ponto de partida claro e objetivo a n\u00edvel da UE para os per\u00edodos de prote\u00e7\u00e3o de dados, vinculado \u00e0 data de ado\u00e7\u00e3o da decis\u00e3o da UE sobre a subst\u00e2ncia ativa;<\/li>\n
  • esclarecimento de que as autoriza\u00e7\u00f5es provis\u00f3rias desencadeiam o in\u00edcio dos per\u00edodos de prote\u00e7\u00e3o de dados, atrav\u00e9s de um esclarecimento espec\u00edfico do artigo 30.\u00ba e da sua liga\u00e7\u00e3o com o artigo 59.\u00ba, n.\u00ba 6;<\/li>\n
  • O desenvolvimento de uma base de dados centralizada da UE para garantir a consist\u00eancia, reduzir a carga administrativa e tornar o sistema vi\u00e1vel na pr\u00e1tica tanto para as autoridades como para os requerentes.<\/li>\n<\/ul>\n

    Um sistema harmonizado e transparente em toda a UE reduziria custos desnecess\u00e1rios, melhoraria a seguran\u00e7a jur\u00eddica, apoiaria a concorr\u00eancia leal e ajudaria a aumentar a disponibilidade de produtos em toda a UE, preservando, ao mesmo tempo, a prote\u00e7\u00e3o leg\u00edtima dos investimentos em dados regulat\u00f3rios.<\/p>\n

    \u201cA ECCA apoia o objetivo da Comiss\u00e3o de simplifica\u00e7\u00e3o e harmoniza\u00e7\u00e3o\u201d, concluiu Marchesini. \u201cCom altera\u00e7\u00f5es espec\u00edficas, principalmente aos artigos 30.\u00ba e 59.\u00ba, a proposta omnibus pode representar um verdadeiro passo em frente para a seguran\u00e7a jur\u00eddica, a concorr\u00eancia leal e a disponibilidade de solu\u00e7\u00f5es fitofarmac\u00eauticas para a agricultura europeia.\u201d<\/p>","protected":false},"excerpt":{"rendered":"

    Grupo da ind\u00fastria de prote\u00e7\u00e3o de plantas ap\u00f3s a expira\u00e7\u00e3o de patentes alerta que s\u00e3o necess\u00e1rias altera\u00e7\u00f5es espec\u00edficas para evitar extens\u00f5es n\u00e3o intencionais da prote\u00e7\u00e3o, incerteza jur\u00eddica e custos desnecess\u00e1rios.<\/p>","protected":false},"author":110,"featured_media":134791,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[29,489],"tags":[],"class_list":["post-134790","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-europe","category-industry-news"],"yoast_head":"\nECCA Warns Current Food and Feed Safety Simplification Omnibus Needs Targeted Amendments to Deliver on EU-Wide Data Protection - AgriBusiness Global<\/title>\n<meta name=\"description\" content=\"Post-patent plant protection industry group warns that targeted amendments are needed 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