Brazil debates regulatory approach for agricultural bioinputs

The regulation of Law No. 15.070, enacted on December 23, 2024, presents an opportunity for Brazil to establish a regulatory system that leverages its biodiversity and scientific capacity to create agricultural solutions. The law is broad in scope, covering conventional, organic, and agroecological systems, and includes categories such as biostimulants, biological control agents, soil conditioners, biofertilizers, and inoculants.

A technical note from Embrapa regarding the regulation of microbiological bioinputs has sparked debate. Embrapa argues that different strains of the same species can possess distinct functional, agronomic, and risk profiles. Consequently, the company suggests a regulatory system based on the individualized characterization of these strains.

Critics of this approach question whether every intra-specific biological difference should necessitate a new legal risk category, new administrative authorizations, or additional barriers to accessing biological resources. The central debate focuses on whether recognizing genetic or metabolic variability between strains automatically implies a legally relevant change in an organism's risk profile.