The biological inputs market in Brazil reached R$ 6.2 billion in 2025, a 15% growth compared to the previous year, with a treated area already totaling 194 million hectares. The figures, presented by CropLife Brasil during BioSummit 2026, reveal a sector in full expansion. However, this commercial advance occurs in an environment of regulatory transition. The sector is now governed by Law No. 15.070/2024, the new Legal Framework for Biological Inputs, which establishes a distinct registration process from chemical crop protection products, managed by MAPA (Brazilian Ministry of Agriculture) without the participation of ANVISA and IBAMA. The central issue is that innovation and the adoption of new biological technologies are advancing at a faster pace than the publication of the decrees and normative instructions that detail the procedures of the new law. This gap between the legislation and its full operationalization creates a scenario of uncertainty. For Regulatory Affairs teams, the situation demands proactive monitoring. Registration dossiers prepared based on previous regulations may require significant adjustments to meet the criteria that are yet to be defined for the new legislation. The main practical implication is the risk of delays and the need for rework in registration processes. Companies investing in research and development need to align their submission strategies not only with the already published law but also with future infralegal regulations. The technical conclusion is that relying on old processes for a new regulatory framework represents an operational risk. The priority action for teams is the rigorous monitoring of publications in the Diário Oficial da União (Official Gazette of the Union) to anticipate new dossier requirements and ensure compliance of future registrations.

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