{"id":134938,"date":"2026-06-25T10:07:30","date_gmt":"2026-06-25T14:07:30","guid":{"rendered":"https:\/\/www.agribusinessglobal.com\/?p=134938"},"modified":"2026-06-25T10:07:30","modified_gmt":"2026-06-25T14:07:30","slug":"ecca-calls-on-incoming-irish-eu-presidency-to-strengthen-legal-certainty-in-omnibus-x","status":"publish","type":"post","link":"https:\/\/www.agribusinessglobal.com\/pt\/markets\/europe\/ecca-calls-on-incoming-irish-eu-presidency-to-strengthen-legal-certainty-in-omnibus-x\/","title":{"rendered":"A Comiss\u00e3o Europeia de Coopera\u00e7\u00e3o em Energia (ECCA) insta a futura presid\u00eancia irlandesa da UE a refor\u00e7ar a seguran\u00e7a jur\u00eddica no \u00e2mbito do Acordo Omnibus X."},"content":{"rendered":"

O Associa\u00e7\u00e3o Europeia de Cuidados com as Culturas (ECCA)<\/a>, A [nome da organiza\u00e7\u00e3o], que representa a ind\u00fastria de prote\u00e7\u00e3o de plantas p\u00f3s-patente na Europa, est\u00e1 apelando \u00e0 futura Presid\u00eancia irlandesa do Conselho da UE para que apoie altera\u00e7\u00f5es espec\u00edficas \u00e0s disposi\u00e7\u00f5es de prote\u00e7\u00e3o de dados inclu\u00eddas no Regulamento Omnibus de Simplifica\u00e7\u00e3o da Seguran\u00e7a Alimentar e de Alimentos para Animais (comumente referido como Regulamento Omnibus).<\/p>\n

Proposta pela Comiss\u00e3o Europeia em dezembro de 2025, a Omnibus X visa agilizar e simplificar a legisla\u00e7\u00e3o da UE sobre alimentos e ra\u00e7\u00f5es, reduzir encargos administrativos desnecess\u00e1rios e melhorar a efici\u00eancia dos procedimentos regulamentares.<\/p>\n

\u201cAcolhemos com satisfa\u00e7\u00e3o a dire\u00e7\u00e3o da proposta da Comiss\u00e3o e, em particular, o objetivo de introduzir uma maior harmoniza\u00e7\u00e3o a n\u00edvel da UE na gest\u00e3o dos per\u00edodos de prote\u00e7\u00e3o de dados para produtos fitofarmac\u00eauticos p\u00f3s-patente\u201d, afirmou M\u00f3nica Teixeira, Presidente da ECCA. \u201cNo entanto, \u00e9 necess\u00e1rio um n\u00famero limitado de altera\u00e7\u00f5es espec\u00edficas para evitar extens\u00f5es n\u00e3o intencionais da prote\u00e7\u00e3o de dados e garantir que o novo quadro proporcione uma verdadeira seguran\u00e7a jur\u00eddica e harmoniza\u00e7\u00e3o entre os Estados-Membros.\u201d<\/p>\n

Ap\u00f3s o Conselho ter chegado a um acordo sobre partes do pacote Omnibus X em 27 de maio, as discuss\u00f5es prosseguiram sobre a proposta restante, que inclui disposi\u00e7\u00f5es de particular relev\u00e2ncia para as PPPs p\u00f3s-patente. Com a Irlanda a preparar-se para assumir a Presid\u00eancia do Conselho da UE em 1 de julho, ter\u00e1 uma importante oportunidade para facilitar um maior di\u00e1logo t\u00e9cnico e ajudar os Estados-Membros a trabalharem em prol de uma posi\u00e7\u00e3o equilibrada e vi\u00e1vel do Conselho.<\/p>\n

\u201cA Presid\u00eancia irlandesa assumir\u00e1 o cargo numa fase crucial do processo legislativo e est\u00e1 em excelente posi\u00e7\u00e3o para ajudar a construir consenso em torno de um quadro que apoie a agricultura europeia, proporcionando, ao mesmo tempo, maior previsibilidade para as autoridades, os detentores de dados e os requerentes de patentes\u201d, acrescentou Teixeira. \u201cA apresenta\u00e7\u00e3o do texto final do Regulamento Omnibus contribuir\u00e1 diretamente para o objetivo da Presid\u00eancia irlandesa de priorizar a competitividade, a simplifica\u00e7\u00e3o e a seguran\u00e7a alimentar durante o seu mandato.\u201d<\/p>\n

Estabelecer um ponto de partida claro a n\u00edvel da UE<\/h2>\n

Segundo a proposta da Comiss\u00e3o, o per\u00edodo de prote\u00e7\u00e3o aplic\u00e1vel aos dados submetidos para a renova\u00e7\u00e3o de uma subst\u00e2ncia ativa come\u00e7aria com a primeira decis\u00e3o de renova\u00e7\u00e3o relevante tomada por um Estado-Membro.<\/p>\n

A CECA considera que vincular o in\u00edcio da prote\u00e7\u00e3o de dados a uma decis\u00e3o administrativa nacional pode fazer com que a dura\u00e7\u00e3o efetiva da prote\u00e7\u00e3o dependa do cronograma dos procedimentos em cada Estado-Membro. Isso poderia resultar em diferen\u00e7as significativas em toda a UE e prolongar a incerteza jur\u00eddica tanto para os requerentes quanto para as autoridades competentes.<\/p>\n

Segundo a an\u00e1lise da ECCA, o mecanismo proposto poderia, na pr\u00e1tica, transformar um per\u00edodo nominal de prote\u00e7\u00e3o de dados de 30 meses num per\u00edodo efetivo com uma m\u00e9dia de aproximadamente 65 meses. A ECCA recomenda, portanto, o estabelecimento de um gatilho claro e juridicamente seguro a n\u00edvel da UE, vinculado \u00e0 decis\u00e3o formal da UE que renova a aprova\u00e7\u00e3o da subst\u00e2ncia ativa.<\/p>\n

\u201cA prote\u00e7\u00e3o de dados deve refletir a inten\u00e7\u00e3o legislativa, e n\u00e3o o cronograma administrativo\u201d, afirmou Teixeira. \u201cUm ponto de partida comum a n\u00edvel da UE proporcionaria a todos os participantes do mercado e \u00e0s autoridades nacionais a clareza e a previsibilidade de que necessitam.\u201d<\/p>\n

Prevenir extens\u00f5es n\u00e3o intencionais da prote\u00e7\u00e3o de dados<\/h2>\n

A ECCA tamb\u00e9m identificou uma poss\u00edvel consequ\u00eancia n\u00e3o intencional relativa \u00e0 utiliza\u00e7\u00e3o subsequente dos dados de renova\u00e7\u00e3o.<\/p>\n

Em determinadas circunst\u00e2ncias, os dados inicialmente submetidos para dar suporte \u00e0 renova\u00e7\u00e3o de uma subst\u00e2ncia ativa e normalmente sujeitos a um per\u00edodo de prote\u00e7\u00e3o de 30 meses podem ser posteriormente utilizados no contexto de uma primeira autoriza\u00e7\u00e3o de produto. Se esses dados forem considerados necess\u00e1rios para a primeira autoriza\u00e7\u00e3o, poder\u00e3o beneficiar-se de um novo per\u00edodo de prote\u00e7\u00e3o de 10 anos.<\/p>\n

A ECCA considera que a legisla\u00e7\u00e3o deve impedir explicitamente esse resultado, garantindo que os dados recebam o per\u00edodo de prote\u00e7\u00e3o adequado \u00e0 finalidade para a qual foram originalmente submetidos.<\/p>\n

\u201cTrata-se de uma quest\u00e3o t\u00e9cnica com consequ\u00eancias materiais para o acesso ao mercado\u201d, afirmou Teixeira. \u201cQuando os dados de renova\u00e7\u00e3o s\u00e3o posteriormente utilizados num procedimento de autoriza\u00e7\u00e3o, isso n\u00e3o deve resultar inadvertidamente num novo per\u00edodo de prote\u00e7\u00e3o de dez anos. Sem um esclarecimento adequado, os benef\u00edcios pretendidos da harmoniza\u00e7\u00e3o poder\u00e3o ser significativamente reduzidos.\u201d<\/p>\n

Esclarecendo o tratamento das autoriza\u00e7\u00f5es provis\u00f3rias<\/h2>\n

\u00c9 necess\u00e1rio um esclarecimento adicional relativamente \u00e0s autoriza\u00e7\u00f5es provis\u00f3rias concedidas ao abrigo do artigo 30.\u00ba do Regulamento (CE) n.\u00ba 1107\/2009.<\/p>\n

No \u00e2mbito da estrutura proposta, n\u00e3o est\u00e1 suficientemente claro que uma autoriza\u00e7\u00e3o provis\u00f3ria desencadeie o in\u00edcio do per\u00edodo de prote\u00e7\u00e3o de dados aplic\u00e1vel. Isso poderia resultar na presen\u00e7a de um produto no mercado por um per\u00edodo significativo antes do in\u00edcio do per\u00edodo formal de prote\u00e7\u00e3o, estendendo, assim, involuntariamente, a dura\u00e7\u00e3o efetiva da exclusividade.<\/p>\n

A CECA recomenda, portanto, a confirma\u00e7\u00e3o expl\u00edcita de que as autoriza\u00e7\u00f5es provis\u00f3rias desencadeiam o per\u00edodo de prote\u00e7\u00e3o de dados relevante ao abrigo do artigo 59.\u00ba, n.\u00ba 6.<\/p>\n

\u201cUm quadro previs\u00edvel exige que o per\u00edodo de prote\u00e7\u00e3o comece quando os dados permitirem o acesso ao mercado\u201d, acrescentou Teixeira. \u201cReconhecer as autoriza\u00e7\u00f5es provis\u00f3rias como um gatilho melhoraria a consist\u00eancia e evitaria diferen\u00e7as n\u00e3o intencionais entre os caminhos de autoriza\u00e7\u00e3o.\u201d<\/p>\n

Recomenda\u00e7\u00f5es da CECA<\/h2>\n

A ECCA est\u00e1 a solicitar altera\u00e7\u00f5es espec\u00edficas \u00e0 proposta Omnibus X que:<\/p>\n

    \n
  • estabelecer um gatilho juridicamente seguro a n\u00edvel da UE para o in\u00edcio da prote\u00e7\u00e3o de dados, vinculado \u00e0 decis\u00e3o formal da UE que renova a aprova\u00e7\u00e3o de uma subst\u00e2ncia ativa;<\/li>\n
  • garantir que as diferen\u00e7as ou atrasos nos procedimentos administrativos nacionais n\u00e3o prolonguem involuntariamente a dura\u00e7\u00e3o efetiva da prote\u00e7\u00e3o de dados;<\/li>\n
  • esclarecer que os dados de renova\u00e7\u00e3o utilizados posteriormente numa primeira autoriza\u00e7\u00e3o n\u00e3o podem desencadear automaticamente um novo per\u00edodo de prote\u00e7\u00e3o de 10 anos; e<\/li>\n
  • confirmar que as autoriza\u00e7\u00f5es provis\u00f3rias concedidas ao abrigo do artigo 30.\u00ba desencadeiam o per\u00edodo de prote\u00e7\u00e3o de dados aplic\u00e1vel nos termos do artigo 59.\u00ba, n.\u00ba 6.<\/li>\n<\/ul>\n

    Como medida complementar de implementa\u00e7\u00e3o, a CECA tamb\u00e9m incentiva a considera\u00e7\u00e3o de um mecanismo de transpar\u00eancia e rastreamento em n\u00edvel da UE, como um banco de dados central, para registrar os per\u00edodos de prote\u00e7\u00e3o de dados aplic\u00e1veis e apoiar uma gest\u00e3o mais consistente em todos os Estados-Membros.<\/p>\n

    A ECCA est\u00e1 pronta para trabalhar de forma construtiva com a futura Presid\u00eancia irlandesa, os representantes dos Estados-Membros, o Parlamento Europeu, a Comiss\u00e3o Europeia e outras partes interessadas para garantir que o texto final proporcione maior seguran\u00e7a jur\u00eddica e apoie um mercado interno mais previs\u00edvel e eficaz para as PPPs p\u00f3s-patente.<\/p>","protected":false},"excerpt":{"rendered":"

    Altera\u00e7\u00f5es espec\u00edficas ao quadro de prote\u00e7\u00e3o de dados proposto ajudariam a garantir que o pacote proporcione maior harmoniza\u00e7\u00e3o, previsibilidade e competitividade em toda a UE.<\/p>","protected":false},"author":110,"featured_media":134939,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"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-134938","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-europe","category-industry-news"],"yoast_head":"\nECCA Calls on Incoming Irish EU Presidency to Strengthen Legal Certainty in Omnibus X - AgriBusiness Global<\/title>\n<meta name=\"description\" content=\"Targeted amendments to the proposed data protection framework would help ensure that the package delivers greater harmonization, predictability, and competitiveness across the EU.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.agribusinessglobal.com\/pt\/markets\/europe\/ecca-calls-on-incoming-irish-eu-presidency-to-strengthen-legal-certainty-in-omnibus-x\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ECCA Calls on Incoming Irish EU Presidency to Strengthen Legal Certainty in Omnibus X - AgriBusiness Global\" \/>\n<meta property=\"og:description\" content=\"Targeted amendments to the proposed data protection framework would help ensure that the package delivers greater 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