Bio-input regulations could define Brazil's leadership.

The future of one of the most strategic sectors of Brazilian agriculture, that of bio-inputs, is entering a decisive stage regarding its strengthening in the next decade. For the National Association for the Promotion and Innovation of the Biological Industry (Anpii Bio), an entity that represents industries that develop and produce biological inputs, the regulation of the Bio-inputs Law (Law No. 15.070/2024), whose preliminary decree was consolidated by the Ministry of Agriculture (Mapa) in December of last year, will define whether or not Brazil will continue to be a global leader in the use and production of these technologies, which are essential for the modernization of the national agribusiness and its sustainable growth.

The preliminary text of the decree was developed after months of discussion within a Working Group (WG) established by the Ministry of Agriculture, bringing together approximately 25 actors from different links in the chain, including government agencies and representative associations from the productive sector and industry. As the only entity exclusively representing the bio-input industry in the discussions, Anpii Bio structured a technical and an institutional front to defend a regulatory framework capable of ensuring innovation, competitiveness, and legal certainty for the sector.

“We cannot in any way relinquish this leading role, because what is at stake is not just the regulation of a law, but the definition of the technological development environment of the bio-inputs industry in Brazil and, of course, the construction of a modern legal framework, aligned with science and international best practices in one of the most relevant sectors from an economic and environmental point of view,” says Thiago Delgado (pictured), president of the entity, which today brings together around 60 companies, including science-based startups, technology developers and bio-inputs industries, as well as companies in the veterinary bio-inputs segment.

In its statement, the organization emphasizes the need for the regulatory framework to be viable for the industry and producers, to promote innovation in a sustainable way, to expand access to increasingly effective products in the field, and to allow technological development to go hand in hand with the economic and environmental viability of agricultural production.

“Brazil has unique conditions for this: we have science, industrial capacity, and one of the largest agricultural markets on the planet. If we get the regulations right, we can consolidate our position as a world reference in bio-inputs,” continues the president of Anpii Bio.

The five critical axes that should be incorporated into the decree, according to the entity, are: production and registration of multifunctional and hybrid bio-inputs; harmonization of international and scientific terminologies and combating misuse; objective criteria and deadlines for regulatory analyses; on-farm bio-inputs with technical responsibility and traceability; and safety for innovation and rigor in quality control.

Production and registration of multifunctional and hybrid bio-inputs 

A historical defense by Anpii Bio argues that multifunctionality is an inherent characteristic of biological products, since certain microorganisms are naturally capable of performing different agronomic functions, such as pest and disease control, nutrition, and plant growth promotion. Previously, however, the same product needed to be registered in different categories, which generated regulatory distortions, bureaucratic duplication, unnecessary costs, and legal uncertainty.

“For us, this recognition in the preliminary text was a great achievement. However, it is essential that technical rigor be maintained and that products be registered only after each function has been duly proven,” explains Júlia Emanuela de Souza (pictured), director of institutional relations at Anpii Bio and representative of the entity during the GT discussions.

Along the same lines, the organization also advocates for the creation of a specific regulatory framework for hybrid products, which combine bio-inputs with fertilizers and/or pesticides, in order to ensure a viable regulatory path for integrated technological solutions. Furthermore, it believes it is essential that the legal framework recognizes multifunctional establishments, allowing a single unit to manufacture different categories of bio-inputs safely and with control – provided they demonstrate good manufacturing practices, adequate process segregation, and full traceability.

Harmonization of international and scientific terminologies and combating misuse. 

Aligning the terminology of bio-inputs with the scientific and international landscape is another criterion advocated by the entity as fundamental for strengthening national agriculture in the global context. Furthermore, harmonization prevents regulatory fraud, misuse, and divergent interpretations, protects rural producers from incorrect or incomplete information, guarantees fair competition, and ensures technical coherence. “In this sense, the final text, when defining categories such as biofertilizers and biostimulants, for example, should contain clear, technical concepts without overlaps,” continues Júlia Emanuela.  

Objective criteria and deadlines for regulatory analyses. 

Predictability is also seen by Anpii Bio as an essential condition, since without it there is no legal certainty or incentive for investment in innovation. Therefore, registration and classification decisions must be guided by clear and objective technical criteria, accompanied by transparent procedures provided for in standards, stable rules and defined deadlines.

Regarding the registrant, the association advocates adopting the model already in place in other regulated sectors, allowing the registration holder to not be required to have their own production structure, provided they are legally qualified and have outsourced production under their responsibility.

Furthermore, the association proposes binding maximum deadlines for each stage of the registration and post-registration processes, with mandatory justification of decisions, guarantee of technical rebuttal, and increased transparency of administrative acts, in accordance with the Access to Information Law (Law No. 12.527/2011), strengthening the regulatory environment and reducing uncertainties.

On-farm bio-inputs with technical responsibility and traceability. 

Regarding the proliferation of bio-inputs on rural properties, the so-called "on-farm" production, Anpii Bio believes that the preliminary text of the decree does not establish clear rules that guarantee regulatory rigor proportional to the risk, nor sanitary control equivalent to that technically required for quality production. According to the organization, this could create distortions that hinder the development of new technologies.

“A potentially pathogenic microorganism does not cease to represent a threat to health and the environment simply because it has multiplied within a rural property. Therefore, biosecurity and quality control criteria need to be equivalent for both industry and on-farm production,” warns Júlia Emanuela, director of the industry association.

Furthermore, another critical point is the on-farm multiplication of commercial products without mechanisms for recognizing or remunerating the developer. “This is something that can discourage the industry from launching new biological solutions. How can an innovation be economically viable if it can be used without remunerating the company or institution that made the innovation? This discourages investment and hinders the development of new technologies capable of increasing sustainability and productivity in the field,” mentions Thiago Delgado, president of Anpii Bio.  

In this sense, the entity understands that legislation should guarantee producers' access to these technologies, but measures such as the exclusive use of authorized strains, a responsible technician when handling isolated microorganisms, registration of production units, and control mechanisms such as volume definition per area, supervised transport, and accident containment protocols should be adopted. Furthermore, it advocates for the adoption of positive lists of inputs and full traceability of all stages.

Safety for innovation and rigorous quality control. 

Finally, the fifth pillar advocated seeks to balance the encouragement of innovation with technical, environmental, and sanitary responsibility. In the area of ​​quality, it supports concrete measurement and control mechanisms, with structured laboratory systems, in addition to mandatory participation in interlaboratory programs – a proposal exclusive to Anpii Bio, which aims to strengthen the scientific credibility of the sector.

Regarding reverse logistics, it proposes phased implementation for product categories that currently lack an implemented system, proportional to the toxicological and environmental profile of the products, with timelines compatible with the sector's maturity and regulatory and economic incentives. This proposal, also exclusive to the entity, aims to ensure environmental responsibility without creating disproportionate barriers to low-risk bio-inputs, promoting a technical transition that encourages good practices and sustainable innovation.

Finally, regarding biological inputs for veterinary use, the association argues that scientifically proven effects should be disclosed on labels and package inserts, ensuring regulatory consistency, the right to technical information, and communication based on scientific evidence, strengthening transparency and equality among technologies with proven efficacy.