“Bioinputs Law and the Future of Regulation.” Article by Senior Partner João Emmanuel Cordeiro Lima is published in Valor Econômico, both in its online and print editions.
Bioinputs Law and the Future of Regulation
The regulatory process is expected to be conducted with active participation from private sector stakeholders and civil society.
By João Emmanuel Cordeiro Lima
The recent enactment of the Bioinputs Law (Law No. 15.070/2024) marks a milestone for agriculture and industry in Brazil. Resulting from extensive discussions among regulatory agencies, the National Congress, and the private sector, the new law brings legal certainty to the production and use of bioinputs in the country. It also establishes a favorable environment for innovation in the sector, reinforcing Brazil’s leadership in a strategic and expanding global market. Despite the significant progress, there is still a path ahead to ensure the law’s full effectiveness.
According to a study by Fundação Getulio Vargas (FGV) and CropLife Brasil, the bioinputs market in Brazil has grown at an average annual rate of 21%, surpassing BRL 5 billion in the 2023/2024 harvest. Globally, the market is projected to continue growing at a rate of 13% to 14% per year through 2032, reaching around USD 45 billion — about three times its current value.
Prior to this new law, bioinputs were regulated by legislation originally designed for chemical, synthetic, or mineral products, such as pesticide and fertilizer laws, as well as infralegal regulations that attempted to adapt the existing legal framework to the particularities of bioinputs. This posed significant challenges. A notable example involved dual-purpose products. Due to their biological nature, these products often have multiple potential uses, leading to classification under different and separate regulatory categories. This required producers to comply with multiple, unharmonized laws to fully utilize their products — resulting in unjustifiable complexity. By unifying the regulation, the new law fills various gaps in the sector and provides a more suitable regulatory framework.
Another major advancement is the streamlining of the bioinput registration process, now under the exclusive authority of the Ministry of Agriculture and Livestock (MAPA). This change addresses a major bottleneck in the previous system. Bioinputs classified as pesticides, for instance, had to undergo a lengthy tripartite evaluation process involving MAPA, Anvisa, and Ibama — each operating independently. Under the new law, these agencies will only be required to weigh in on the registration of new products for phytosanitary control, at a time and in a manner still to be determined.
The authorization for the production of bioinputs for personal use — known as on-farm production — also deserves special attention. This model allows rural producers to manufacture and multiply biological products for their own use, with simplified registration of the production unit. These on-farm bioinputs are not subject to MAPA registration but also cannot be marketed. By setting clear rules for on-farm production, such as the requirement for good practices, the law clarifies the legal landscape and establishes limits for an activity that is already a reality in the country.
The previous legal framework also introduced transitional rules pending full regulation. Three stand out:
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Authorization for the continued use of bioinputs that lacked specific regulation until the publication of specific standards — a solution for products that previously did not fit into any existing regulatory category.
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Registrations granted before the law’s publication remain valid until their expiration date, and prior regulations remain applicable to new registrations until the specific regulation of the Bioinputs Law is defined.
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Continued production of bioinputs for personal use is permitted until new regulations and good practice guidelines are published.
Although the law’s publication is a major step forward, challenges remain to ensure its full implementation. To allow for the best technical approach and the flexibility necessary to avoid obsolescence, several important aspects were left for later regulation. Regarding product registration, for example, issues such as the role of Anvisa and Ibama in the process, as well as classification criteria, specifications, and minimum parameters, must still be defined — with consideration for the purposes and categories of each bioinput. Additionally, topics related to importation, exportation, commercialization, use, waste disposal, packaging, labeling, and inspection will also require regulation.
Given the relevance of these issues and the coordination that enabled the law’s creation, it is expected that the regulatory process will involve active participation from private sector stakeholders and civil society. This approach will help uphold the ideal of streamlining regulatory requirements for the category. With this, Brazil aims to remain strategically positioned in the global bioinputs market, leveraging its rich biodiversity and driving innovation in the sector.
João Emmanuel Cordeiro Lima holds a PhD in Diffuse and Collective Rights from PUC-SP and is a partner at Nascimento e Mourão Advogados.
This article reflects the author’s opinions and not those of Valor Econômico. The newspaper is not responsible for the information provided herein or for any loss of any kind resulting from the use of this information.
Published in Valor Econômico, February 18, 2025, 05:02 AM.
https://valor.globo.com/legislacao/coluna/lei-de-bioinsumos-e-o-futuro-da-regulacao.ghtml
