Brazil's New Bioinputs Law: A New Regulatory Landscape for Sustainable Agriculture

Editor's Note: In March 2025, Mr. Henrique Bley, Deputy Director of the Department of Plant Health and Agricultural Inputs and the General Coordinator of the Fertilizers, Biofertilizers and Inoculants Division, Department of Agriculture and Livestock (MAPA) of Brazil, delivered a speech titled " Brazil's New Bioinputs Law: A New Regulatory Landscape for Sustainable Agriculture" at the 6th Biopesticides, Biostimulants and Biofertilizers Summit (BioEx 2025). As a core driving force behind Brazil's bio-inputs policy, Mr. Bley revealed how Brazil is creating a global benchmark for bio-agriculture through dynamic regulation and technological innovation, drawing from national experience, regulatory innovations, and industry practices.

Mr. Henrique Bley, official of Brazil MAPA, delivered a speech at BioEx 2025

The Foundation of Brazilian Bio-Agriculture: Research, Industry, and Regulatory Synergy

Mr. Bley began by pointing out that the robust development of Brazilian bio-agriculture stems from the deep integration of three pillars: 

70 Years of Research Accumulation: Brazil has 70 years of experience in product development, including biological solutions. The Brazilian Agricultural Research Corporation (Embrapa) is a crucial research institution that has been deeply engaged in microbial technology development for over 50 years, particularly establishing global leadership in nitrogen-fixing bacteria applications and biocontrol. 

Highly Trusted Industry Chain: Brazil has registered over 1,500 biological products; farmers have a high acceptance of biotechnology; and the industry, driven by confidence in agriculture, invested a lot in this sector. All these forms an efficient "laboratory enterprise-field" transformation chain. 

Trinity Regulatory Framework: The Ministry of Agriculture and Livestock (MAPA), the National Health Surveillance Agency (ANVISA), and Institute of the Environment and Renewable Natural Resources (IBAMA) collaborate and divide responsibilities, respectively overseeing the registration of pesticides for agricultural use and setting standards for product efficacy, evaluating the safety of pesticides for public health, and ecotoxicological research, ensuring a balance between industry development and ecological safety. 

"Brazil's agricultural success proves that research is the foundation, industry is the engine, and clear regulatory rules are the guarantee of sustainable growth," Mr. Bley emphasized. 

Applied Agri-input Legislations in Brazil

New Regulations Implementation: Simplifying Bioinputs Registration Process and Expanding Category Definitions 

Mr. Bley focused on interpreting the regulatory system that is currently applicable, highlighting two topics: 

Accelerated Registration Process: Introducing a " Reference Specification ("ER") " pathway, where companies can quickly complete registration based on a list of 60 certified microorganisms, reducing approval cycles from 5 years to 1 year. Currently, 40% of biological products are approved through this pathway, significantly reducing corporate compliance costs. 

Expanded Category Definitions: Based on the "New Bioinputs Law" that came into effect in December 2024, for the first time, "bioinputs" are definitively defined as "product, process, or technology of plant, animal, or microbial origin, including those derived from biotechnological processes, or structurally similar and functionally identical to a natural origin, intended for use in the production, protection, storage, and processing of agricultural products or in aquatic production systems or planted forests." This covers diverse categories such as biological control agents, biofertilizers, inoculants, biostimulants, and soil conditioners, with particular emphasis on supporting small holders and organic fertilizer production. 

Mr. Bley specifically mentioned the challenges of differentiated classification systems: "For example, nitrogen-fixing bacteria are classified as 'inoculants' in Brazil, while in other countries they might be considered biostimulants. We plan to adjust the classification logic in 2025 to enhance international compatibility."

Practical Challenges: Microbial Multifunctionality Causing Registration Difficulties

Despite the new law injecting vitality into the industry, Mr. Bley candidly acknowledged that the multifunctionality of bioinputs remains a challenge for regulatory adaptation. "The same microorganism might simultaneously possess soil improvement, pest control, and growth promotion functions, requiring companies to apply for multiple registrations for different uses." He cited Bacillus as an example, which in Brazil must be registered separately as a "growth regulator," "biopesticide," and "soil conditioner," leading to redundant data submissions and resource waste. 

To address this, Brazil is advancing the following strategies: 

Constructing an Inter departmental Database: Creating a public application for finding all registered products.

Encouraging Compound Product Development: Incentivizing companies in enhancing product comprehensive effectiveness through compound research, such as developing biologicals with both disease resistance and nutritional supplementation capabilities.

Coordinating National and International Legislation: Continuously working to coordinate national and international legislation, reducing bureaucracy and accelerating product market availability. 

Bioinput registrations for plant protection – Biocontrol

Global Cooperation Vision 

In the closing of his speech, Mr. Bley called for strengthening international cooperation, stating, "The future competition in bio-agriculture will not just be about technological breakthroughs, but about regulatory wisdom and industrial environment. Brazil is willing to deepen cooperation with countries globally to jointly promote bio-agriculture from an 'alternative option' to a 'mainstream choice'." 

(This article is compiled based on Henrique Bley's on-site speech and publicly available information from the Brazilian Ministry of Agriculture)

This article was published in AgroPages magazine 2025 CROs & CRAOs Manual.