Does the regulatory framework meet the bioinput sector's needs?

One of the highlights of the BioSummit 2025 program was the panel entitled: "Does the current regulatory framework meet the bioinput sector's needs? What are the main challenges?" AgroPages provided special coverage of the panel discussion and reports the most important insights shared by leading figures in the biological inputs sector who participated in the discussion.

The panel discussed the main regulatory advances and bottlenecks that impact the expansion of Brazil's bioinput sector following the approval of the 2024 Bioinputs Law (Law No. 15,070/2024). This approach comes at a decisive moment for formulating guidelines that ensure legal security, innovation, and competitiveness for companies in the bioinput sector.

Julia Emanuela de Souza, institutional relations director at ANPII Bio (National Association for Promotion and Innovation in the Biological Industry), stated during the panel discussion that her organization has been actively working to ensure that the new law's regulation reflects, in depth, the sector's technical and commercial needs.

According to de Souza, the more than 49 member companies are coordinating with Brazil's Ministry of Agriculture and Livestock (MAPA) and other regulatory bodies. "We are developing a normative proposal based upon scientific evidence and built collaboratively with our members," she said. 

During the panel, de Souza highlighted the importance of quality control in all varieties of bioinput production.  Both industries and "on-farm" manufacturers must comply with these same quality control criteria, as well as innovation in regulation, so that new technologies can be registered, she noted.

Additionally, de Souza noted that bioinputs "are profitable for producers and contribute to more sustainable agriculture."  De Souza also reiterated the need for "specific regulation for bioinputs intended for animal production."

 De Souza further noted that public-private partnerships (PPPs) are fundamental for development of the sector, from collaborations with research and educational institutions, such as Embrapa, to involvement with regulatory bodies responsible for public policies.

Also participating was lawyer Lidia Cristina Jorge dos Santos, from the Figueiredo e Santos Law Firm, representing SINDIVEG (National Union of the Plant Defense Products Industry) at BioSummit 2025. During the panel discussion focusing on the new Bioinputs Law, she addressed the question of whether the new regulatory framework is aligned with the sector's objectives and what the main challenges are for its implementation.

"A central point of our contribution was the need for awareness about the legal change: the regulatory key shift that distinguishes bioinputs from agricultural pesticides. We also emphasized the importance of immediately applying the new law in areas where there is no need for infralegal regulation — respecting legality, but without wasting time,″ dos Santos said.

Marcos Pupin, director of Regulatory and Scientific Affairs at the Brazilian Association of Bioinnovation (ABBI), reinforced the importance of legislation that respects innovation in biological inputs, especially regarding genetic engineering. Additionally, he highlighted the relevance of macroorganisms for national agro-industries, particularly for use in sugarcane mills.

In her remarks, Amália Piazentim Borsari, Executive Director of Biological Products at CropLife Brasil, addressed the importance of the internationalization of Brazilian biological companies and the essential role of innovation in the development of the sector.

ABINBIO (Brazilian Association of Bioinput Industries) was also one of the supporting entities at BioSummit 2025. Mauro Brant Heringer, Master of Law and Director of International Relations at ABINBIO, has been urging that the new Bioinputs Law establish rigorous standards for the production, storage, and commercialization of bioinputs, to ensure product quality and safety.

Heringer points out the need, however, to harmonize the law with other environmental and agricultural legislation and to invest in infrastructure for research, production, and large-scale distribution. The permission for "on-farm" production without commercial registration, with restrictions such as the prohibition of using commercial products as inoculum sources, has created tensions between the sector and farmers. Heringer noted that the concern is that a lack of rigor in regulation could undermine confidence in the bioinputs market.

Law 15,070 seeks not only to define what biological products are, but also to regulate the entire process, from classification to the analysis of results. This path toward a more adequate technical, legislative, and commercial environment is seen as positive.

(Editing by Leonardo Gottems, reporter for AgroPages)