In December 2024, Brazil enacted its first comprehensive regulation specifically targeting biological inputs—Regulation No. 15.070—marking a major breakthrough in the country's biological input regulatory system. Biological inputs, which were previously governed by scattered fertilizer and pesticide regulations, have now been formally integrated into a unified, dedicated regulatory framework. To conduct an in-depth analysis of the core content of the new regulations, their practical impact on the industry, and enterprise response strategies, this article deciphers the value of the new regulations from an industry practice perspective based on interviews with Daniela Maia, Head of Regulatory Affairs at Staphyt Brazil, and Andréia Shiwa, Manager of Regulatory Affairs and Product Registration at SynTech Research Brazil.

Core Breakthrough of the New Regulations: Systematic Restructuring from Fragmented to Integrated Framework

The most notable transformation of the new regulations is the separation of biological inputs from the traditional fertilizer and pesticide regulatory systems, establishing an independent and unified regulatory framework. Staphyt points out that the new regulations cover a wide range of biological inputs, including biocontrol products (such as microbial pesticides, beneficial natural enemies, semiochemicals, etc.), biostimulants, and biological fertilizers (such as inoculants), ending the chaotic situation where similar products were previously governed by different regulations.

SynTech further clarifies that Regulation No. 15.070, officially issued on December 24, 2024, establishes Brazil's first comprehensive regulatory framework for biological inputs used in agriculture, animal husbandry, aquaculture, and forestry. Its core features are reflected in three aspects: first, comprehensive application scenarios, covering various production models such as conventional, organic, and ecological agriculture; second, complete regulatory objects, covering not only all biological inputs themselves but also requiring registration of all entire-chain entities including producers, importers, exporters, and traders; third, differentiated management, exempting registration requirements for specific scenarios such as semiochemical products used in traps and those derived solely from fermentation of food and its residues, as well as biological inputs produced for on-farm use only (commercial sales are prohibited).

In terms of functional integration and policy support, the new regulations demonstrate a clear industrial orientation. Staphyt emphasizes that the new regulations allow products with multiple functions (such as plant protection + nutrition) to be registered through a single pathway, creating favorable conditions for product combinations and enabling the integration of composite effects. At the same time, Brazil's National Biological Input Program is expected to provide credit/funding support to finance the construction of biological input production facilities (i.e., potential R&D support), and Brazilian enterprises should make good use of these mechanisms.

Reconstruction of Application Strategies: Registration Paths, Category Classification, and Compliance Key Points

The restructuring of the regulatory framework directly drives the adjustment of enterprise application strategies. SynTech points out that enterprises first need to redefine product categories according to the new regulations and adjust application materials accordingly to ensure compliance and accelerate market access. Staphyt adds that the modern legislative environment brought by the new regulations will significantly optimize the regulatory experience; although the details of the regulations are still being refined and implemented, the government's promotion efforts are clear, and the industry will have sufficient growth momentum in the future.

Regarding the registration of biological-chemical compound products that enterprises are concerned about, Staphyt gives a clear response: Yes, such products need to meet the strictest regulatory requirements of both biological and chemical product categories, making the registration complexity significantly higher than that of pure biological products. In terms of time costs, the current registration of biological products takes about 1 year, while chemical products take an average of 5 years, so the approval cycle for compound products may face greater challenges, and enterprises need to make advance plans.

Enterprises need to accurately grasp the boundaries when using registration exemptions and incentive policies. According to SynTech's summary, the new regulations exempt registration in two scenarios: first, specific semiochemical products, such as those used in traps and derived solely from fermentation of food and its residues; second, biological inputs produced for on-farm use only (commercial sales are strictly prohibited). At the same time, the new regulations provide financial incentives for R&D and simplify the approval process for low-risk products, which will further lower the market access threshold for small and medium-sized enterprises.

Analysis of Category Differences: Core Distinctions and Key Control Points in Registration Requirements

There are significant differences in registration requirements among different categories of biological inputs, and accurately grasping these differences is key for enterprises to avoid risks. Staphyt breaks down the core differences from two aspects: approval authorities and data requirements. New biological pesticides (containing new active ingredients) still require joint review by Brazil's three major competent authorities—Ministério da Agricultura e Pecuária (MAPA), Agência Nacional de Vigilância Sanitária (ANVISA), and Ministério do Meio Ambiente e Recursos Renováveis (IBAMA). In addition to agronomic efficacy reports, toxicology, ecotoxicology, and physical and chemical property research reports must also be submitted. Biological pesticides containing registered active ingredients will adopt a simplified process, with review conducted solely by MAPA. Products previously classified under fertilizer regulations will maintain the existing model, with independent review by MAPA only.

SynTech reveals the root cause of differences from the perspective of product essential attributes, believing that product sources (products, processes, or technologies derived from plants, animals, or microorganisms, including biotechnological processes, or those with similar structures and equivalent functions to natural sources) or product mechanisms of action are the core factors determining registration requirements. Products from different sources have inherent differences in the focus of safety assessment and efficacy verification, and enterprises need to match corresponding technical data requirements based on product characteristics.

Risk Avoidance Guide: Core Causes of Registration Delays and Rejections and Solutions

Delays and rejections during the registration process are the most common pain points for enterprises. The two experts provide targeted suggestions based on practical experience. Staphyt points out that poor quality of registration dossiers is the primary cause of delays. Some enterprises submit incomplete or unconvincing data due to insufficient understanding of regulations or eagerness to meet deadlines, directly affecting the approval progress. Research quality is also a prominent issue. For example, in the case of microbial products, some enterprises incorrectly use testing methods designed for chemical products, leading to inability to accurately assess the product's impact on human health and non-target organisms, and ultimately having to re-conduct research.

Inappropriate selection of field trial areas is another common problem. Brazilian regulations require efficacy trials to be conducted in three different regions representative of the crop. However, due to unclear definition of trial areas in the regulations, if the trial areas selected by enterprises are not optimal for the target pests or crops, MAPA may require re-testing, and the communication and re-testing process alone can take several months. In this regard, Staphyt suggests that enterprises conduct Data Gap Analysis (DGA) in accordance with Brazilian regulatory requirements in advance, supervise the research process in strict accordance with local standards, and ensure the quality of dossiers. After submission, enterprises should continuously track the review status and maintain close communication with regulatory authorities.

Regarding the issue of approval uncertainty, SynTech puts forward practical suggestions: the current regulations are in the transition period, and some supporting policies are still under evaluation, so it is expected that there may be coordination issues in some approval processes. However, since Brazil adopts the "first-come, first-served" principle and has opened a priority channel for biological products, enterprises should submit applications as soon as they are fully prepared to seize market opportunities. In terms of preventing rejection risks, Staphyt emphasizes that regulatory authorities usually handle issues by requesting supplementary materials rather than direct rejection. However, if the research data clearly required by regulations is missing and no reasonable technical explanation is provided, the approval process may be terminated directly during the document review stage. Incorrect product classification (such as misdeclaring pesticides as biostimulants) is also a common cause of rejection. Enterprises need to accurately define product categories before application and, if necessary, conduct pre-communication with regulatory authorities.

International Perspective: Equal Regulation for Domestic and Foreign Enterprises and Differentiated Challenges

Regarding the issue of access fairness that international enterprises are concerned about, Staphyt clearly states that the new regulations implement unified data requirements and approval processes for both domestic and foreign enterprises, with no discriminatory clauses. However, it should be noted that all registration applications must be submitted by Brazilian local enterprises with legal qualifications for pesticide and fertilizer operation, which constitutes a certain threshold for foreign enterprises. It is recommended to solve the qualification issue through cooperation with local consulting agencies, partners, or distributors.

SynTech further points out that international enterprises also need to address challenges brought by standard differences. For example, Brazil's definition of biostimulants and registration requirements for protein and polypeptide-based biocontrol products are significantly different from those in markets such as the United States and Europe; registration requirements for new inoculants and biological fertilizers are also relatively stricter. Enterprises need to conduct targeted localized research and avoid directly applying technical data from other markets.

Conclusion: Opportunities and Prospects of Industry Upgrading Driven by Regulatory Innovation

The introduction of Brazil's first comprehensive regulation on biological inputs is not only a systematic restructuring of the regulatory system but also an important catalyst for industrial development. The unified regulatory framework, registration convenience for multi-functional products, and policy support for R&D will collectively activate the innovation vitality of the biological input market. For enterprises, accurately grasping category differences, optimizing application strategies, strictly controlling research quality, and making good use of policy dividends are the core paths to respond to changes. With the gradual implementation of regulatory details, Brazil's biological input market is expected to usher in a new round of growth and become an important growth pole in the global biological agriculture field.