The impacts of the new bioinputs law on Brazilian agribusiness

The enactment of Law No. 15.070/2024 in December 2024 represented a milestone for Brazilian agriculture. For the first time, the country now has a specific and comprehensive legal instrument to regulate the production, marketing, monitoring, and use of biologically derived inputs for agriculture. The goal is to reduce dependence on chemical inputs, encourage sustainable practices, and foster innovation, placing Brazil at the forefront of a regulatory framework exclusively for bioinputs.

The sector already demonstrates economic and environmental relevance: it generates approximately R$5 billion per harvest and registers annual growth of 13% in the area treated—a rate higher than the global average—according to a study by CropLife Brasil in partnership with the FGV Bioeconomy Observatory. In the 2023/2024 harvest, bioinputs covered 26% of the planted area in Brazil, with strong adoption in crops such as soybeans, corn, and sugarcane. The new legislation covers two main areas: industrial biofactories, subject to rigorous technical standards, and on-farm production, which authorizes producers to manufacture biological inputs for internal use, under simplified rules.

Despite the progress, challenges remain: expanding technical assistance, ensuring traceability, and consolidating data on production and use. The law's regulation, scheduled for completion by December 2025, will be crucial in establishing the operational details that will enable this regulatory innovation.

To discuss impacts and prospects, Insper Agro Global spoke with Leonardo Munhoz, a researcher at the Center for Agribusiness Studies (FGV Agro) and the Bioeconomy Observatory at Fundação Getulio Vargas. A lawyer with a PhD and master's degree in Environmental Law from the Elisabeth Haub School of Law at Pace University (USA), Munhoz specializes in the sector's regulatory frameworks.

What were the main advances brought by Law 15.070/2024 in relation to previous legislation?

The most important advancement is the unprecedented nature of the legal framework. This is the first law to specifically address bioinputs in Brazil. Previously, these products were regulated in a disparate manner, often as if they were chemical pesticides, which created legal uncertainty and delayed technology adoption. The new law creates a clear distinction between chemical and biological inputs—in both fertilizers and pesticides—and introduces a unique approach to bio-based products.

Another key point is the distinction between commercial production, carried out by biofactories, and on-farm production, carried out by rural producers themselves. This distinction, in addition to recognizing an existing practice, provides legal support and allows for the adoption of different standards of demand, depending on the scale and risk involved. This is particularly relevant for small and medium-sized producers, who previously operated in a regulatory gray area.

Why did Brazil choose a regulatory model that is different from what exists in other regions of the world?

This distinction stems from a practical necessity. In many countries, such as the United States, on-farm bioinput production is covered by pesticide regulations. In the European Union, it is linked to organic production. Brazil's move was innovative: it created a specific and independent regulatory framework, not subject to either the chemical or organic pesticide logic.

This is important for two reasons. The first is regulatory clarity: it avoids regulatory conflicts and overlaps, which often generate legal uncertainty. The second is the recognition that bioinputs don't fit neatly into any of the previous models—they have particularities that require their own regime. By establishing this new framework, Brazil assumes a leadership role, becoming the first country in the world to treat bioinputs this way.

Furthermore, the law helps to pacify a historical tension between industry and producers. There was a perception that on-farm production could compete unfairly with biofactories. The new regulation demonstrates that both forms of production are legitimate and can coexist, as long as they respect the established limits and requirements.

Will on-farm production have concrete impacts for smaller producers?

Without a doubt. The regulation of on-farm production represents a great opportunity for small and medium-sized producers. By allowing them to produce their own bioinputs, with less bureaucracy and without the need for federal registration, the law paves the way for cost reduction and greater technological autonomy.

However, it's important to emphasize that this production cannot be done haphazardly. The idea that simply mixing a few microorganisms in a drum is sufficient is misleading. Effective on-farm production requires infrastructure, technical expertise, and often equipment similar to that of a smaller-scale biofactory. This is why legal regulation will be crucial to define minimum requirements, best practice guidelines, and quality control mechanisms.

Another issue that needs to be addressed is registration. The law requires producers to register with the Ministry of Agriculture's system, but it's still unclear what this registration will require, how it will be implemented, and who will oversee it. If this isn't clearly outlined, there's a risk of legal uncertainty and regulatory inefficiency.

Is the technology needed for on-farm production already available?

Yes, it is available—and is already being applied by producers of some crops, such as cotton. However, it still needs to be disseminated with greater quality. The working group discussing the law's regulation is evaluating alternatives to ensure standardization and effectiveness. One of the proposals under consideration is for the industry to provide standardized biofactory kits. These kits would contain microorganisms in stable formulations and appropriate equipment, as well as good practice manuals.

This standardization would help ensure that on-farm inputs are safe for the environment and human health, while also being effective in controlling pests or promoting plant growth. It's a way to democratize access to biotechnology without compromising quality.

The law allows cooperatives to produce on-farm crops. What precautions should be taken?

The participation of cooperatives is strategic, especially for democratizing access to technology. Small producers often lack the scale or resources to set up their own biofactories. Cooperatives, in turn, can offer infrastructure, training, and technical assistance.

However, it's important to pay attention to one crucial point: the cooperative's production must be intended exclusively for its members, for their own use. If this production becomes commercial—that is, if the cooperative begins selling bioinputs to third parties—it must comply with the requirements applicable to industrial biofactories, including registration with the Ministry of Agriculture and payment of fees.

Therefore, the regulatory decree will need to establish clear limits on scale, traceability, and intended use, in order to avoid distortions and ensure that collective production remains within the parameters of on-farm production.

How does the new law impact the bioinputs industrial sector?

The impact is quite positive. The law creates a clearer and less bureaucratic regulatory environment, which favors investment in innovation. The existence of a specific legal framework signals, including to the international market, that Brazil is committed to the development of the bioeconomy.

An important point is the issue of patents. Currently, the National Institute of Industrial Property (INPI) does not have its own procedures for registering bioinputs, which delays the intellectual property protection process for these innovations. With the new law, these procedures are expected to be developed, providing greater legal certainty for companies investing in research and development of biological solutions.

What is the growth potential of this market in the coming years?

According to a study we conducted at FGV in partnership with CropLife, the bioinputs market in Brazil already generates around R$5 billion per harvest, but this figure is expected to grow significantly in the coming years. Globally, the annual growth rate through 2032 is expected to be between 13% and 14%, reaching approximately US$45 billion, triple the current value.

This growth is due to multiple factors: the pursuit of sustainability, increased pest resistance to chemical pesticides, environmental concerns, pressure for reduced residual impact on food, and, more recently, global geopolitical instability, which has affected supply chains and increased the costs of imported inputs. All of this creates room for local, more sustainable, and competitive solutions.

Could TREPDA, the tax created by the new law, be an obstacle?

The creation of TREPDA (Agricultural Defense Establishment and Product Registration Fee) is a sustainability mechanism for the regulatory system itself. It applies only to biofactories and the trade of bioinputs—on-farm production is exempt. The fees are lower than those currently charged for pesticides, signaling a public policy to encourage biotechnology.

Of course, ideally, we could consider a system without fees, but it's necessary to technically enable product analysis and monitoring. The important thing is that costs are balanced and compatible with the industry's reality, and, in this regard, the new law seems to be right in creating a proportional fee.

Is there a risk of conflict with state laws or the Environmental Licensing Bill?

Formally speaking, no. The Bioinputs Law is a general federal regulation that establishes guidelines for states to follow. What may occur is operational difficulties for states in overseeing on-farm production, as provided for in the new legislation. This will require training, infrastructure, and resources.

Regarding the Environmental Licensing Bill (PL 2.159/2021), there is a gap. The new bioinputs law does not mention environmental licensing, which may raise questions. The bill, in turn, exempts extensive and low-impact agricultural activities, but does not directly address the production of bioinputs. A systematic reading may lead to the interpretation that, in the absence of a specific exemption, both commercial and on-farm production will require licensing. This needs to be harmonized through infra-legal regulation.

Can Brazil play a prominent role in the global bioinputs market?

Brazil has all the elements needed for this. It is one of the largest consumer markets for agricultural inputs in the world, has a solid agroindustrial base, recognized research institutions—such as Embrapa—and now boasts a modern and exclusive legal framework for bioinputs.

Furthermore, we have a comparative advantage: while developed countries concentrate on patent production but don't use the products on a large scale, and developing countries use them but don't produce them, Brazil can do both. We are consumers and, at the same time, we have technological and productive capacity.

Despite the undeniable advances brought by Law No. 15.070/2024 in establishing a specific legal framework for bioinputs, it is important to recognize that its full effectiveness will depend directly on the pending regulatory framework. There is a considerable path to be covered in defining technical criteria, inspection procedures, quality standards, and control mechanisms for both industrial and on-farm production. Without this regulatory detail, risks of legal uncertainty, traceability gaps, and inequalities in law enforcement among Brazilian states persist.

If we make progress on three points—streamlining the patent process, improving state oversight, and clear regulation—we can influence how other countries approach this issue in the coming years.

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