One year after Brazil's New Pesticide Law: What happened?

The record number of pesticide registrations in Brazil in 2024 is not related to the country's new Pesticide Law (Law No. 14.785/23), but rather to the number of requests in queue and some improvements in administrative procedures, particularly in the analysis of equivalent products. This is the conclusion of agricultural engineer Roberto Araújo, member of the Sustainable Agro Scientific Council (CCAS), master in Agribusiness, and post-graduate in Irrigation Engineering and Plant Protection.

The expert sent AgroPages a special analysis of the first year of Brazil's new pesticide law. According to him, the number of post-patent product registrations increased, as did direct imports of formulated products by non-industrial entities, expanding supply, increasing the number of players in the market, and reducing costs for farmers.

Furthermore, Araújo states that for Brazil's input regulatory bodies (MAPA, ANVISA, and IBAMA) to act in an integrated and coordinated manner, as provided for in the new law, it will be necessary to expand the dialogue between the agencies. Additionally, SISPA (Unified Information, Petition, and Electronic Assessment System) and the Unified Registration System need investment for implementation and maintenance, ensuring digital security and technological modernization.

"The staffing structure and resources of regulatory bodies need to be expanded for Brazil to match the standard of international agencies such as EPA (USA), EFSA (EU), PMRA (Canada), and APVMA (Australia). Finally, the regulation of the new pesticide law is delayed and faces challenges. The process resembles a 'Kafka's labyrinth,' where the main stakeholders are trapped in bureaucracy, legal disputes, and structural difficulties that prevent rapid progress," concludes the CCAS member.

See more details from Roberto Araújo's Special Analysis of the first year of Brazil's new Pesticide Law:

One year after Law No. 14.785/23 took effect, which deals with the research, production, commercialization, and use of pesticides in Brazil, the competent bodies have made little progress in regulating the new legislation. The annual growth rate of registrations at the Ministry of Agriculture and Livestock (MAPA) between 2016 and 2024 is 11.5%. Last year's record registrations are not directly related to the publication of the new law, but rather to the growing trend in applications and improvements in administrative procedures for analyzing equivalent products, as we'll see below.

According to FAO, between 1990 and 2022, pesticide use per cultivation area increased by 94% worldwide. The growing trend in registrations in Brazil is justified by the market's high attractiveness for the crop protection industry. Brazil is the 4th largest country in agricultural production volume, being a leader or runner-up in exporting the world's main agricultural commodities (soybeans, corn, cotton, beef and chicken, orange juice, coffee, sugar, and ethanol). Agribusiness exports reached US$164.4 billion, representing 49% of the country's total exports.

By 2050, when UN projections indicate the world population should reach about 9.8 billion inhabitants, Brazil should consolidate its position as one of the main global suppliers of food, fiber, and clean energy, due to its capacity for expanding agricultural production and increasing productivity. In this promising scenario for agricultural inputs, the number of pesticide registration applications in Brazil has increased and, consequently, the number of granted registrations is also growing.

The reduction in registrations in 2023 compared to 2022 may be associated with the government change and its impacts on MAPA, just as the increase in granted registrations in 2024 can be attributed to improved internal processes in the competent bodies, especially in analyzing products equivalent to others already in the market.

The new pesticide law maintained the definition and requirements for equivalent products that already existed in previous regulations, reinforcing that equivalence evaluation should consider:

• Same active ingredient, in the same concentration and with impurities within established standards;

• Same formulation and adjuvants compatible with the reference technical product;

• Equivalent toxicological and environmental profile, as evaluated by Anvisa and Ibama;

• Agricultural efficacy criteria compatible with those already approved for the reference product.

The registration of pesticides by equivalence did not change from the previous law. This registration modality is essential for marketing generic products, as it stimulates competition and reduces costs for agricultural producers.

In 2024, excluding technical product registrations (raw materials intended exclusively for industry), which totaled 199, 464 registrations were granted, as we can verify in the following breakdown:

• 346 registrations of formulated chemical agricultural pesticides equivalent to others already in the market;

• Only 12 registrations of chemical pesticides with new molecules (containing only three new active ingredients);

• 106 registrations of biodefensives.

Expectations for the New Pesticide Law Regulation

One of the crop protection sector's major expectations regarding the new pesticide law regulation is a faster analysis of registration applications for new molecules, as well as an overall reduction in process queues. In this regard, the new law establishes deadlines for approving registration requests, seeking greater predictability, legal security, and alignment with the deadlines provided in Decree No. 10.833/2021:

• 24 months: new formulated or technical product;

• 60 days: equivalent formulated product;

• 30 days: Temporary Special Registration (RET);

• 12 months: other products.

However, these deadlines are still not being met in most cases, leading some companies to resort to legal action to demand that competent bodies analyze their applications.

The new pesticide law took effect on its publication date, December 28, 2023, and Article 44 determined that competent bodies would have 360 days to regulate the provisions in the new text. Despite efforts, these bodies are still drafting regulations and, to date, have published practically no regulations, nor even opened new public consultations. Thus, previous infralegal norms that don't conflict with the new legislation remain in effect. Consequently, changes in administrative procedures for pesticide analysis in 2024 were minimal.

Pesticide Import Acts

After the publication of MAPA Normative Instruction No. 26, dated July 21, 2017, importing formulated pesticides no longer required prior authorization, being subject only to document analysis and verification, plus inspection at customs clearance. Since implementing this regulation, the number of pesticide import acts has nearly tripled.

In this context, the growth in equivalence registrations has contributed to a dramatic increase in direct imports of formulated pesticides by non-industrial companies. According to the Regulatory Intelligence Institute, between 2023 and 2024, the volume of formulated pesticides imported directly from China increased by more than 59%, exceeding 530,000 tons.

Vetoes to Law No. 14.785/2023 and Fees to Fund Improvements

When signing the new law, the President vetoed 17 specific provisions. However, nine provisions have not yet been considered by Congress and remain pending deliberation. These vetoes relate to creating fees for product registration evaluation and allocating collected funds for inspection actions and fostering various activities associated with developing and technically implementing areas for analyzing and registering pesticides and environmental control products, including implementing and maintaining the Unified Information, Petition and Electronic Assessment System (SISPA).

Without a definition of registration fee values and the allocation of collected resources, advancing Brazil's pesticide and bioinput regulation and inspection system will be hindered. This compromises the possibility of matching service standards provided by international reference regulatory agencies, such as:

• United States – Environmental Protection Agency (EPA);

• European Union – European Food Safety Authority (EFSA);

• Canada – Pest Management Regulatory Agency (PMRA);

• Australia – Australian Pesticides and Veterinary Medicines Authority (APVMA).

Improving services provided by competent bodies in Brazil is fundamental, considering agriculture's relevance to the country and society's growing concerns about pesticide use.

Another advancement that should be covered by registration fees intended to fund improvements in regulatory bodies is the new Bioinputs Law (Law No. 15.070, dated December 24, 2024), approved by Congress and signed by the President. This legislation reinforces regulators' commitment to encouraging bioinput use and promoting Brazilian agriculture's sustainability.

Insufficient Staff at MAPA, ANVISA, and IBAMA

The structure of sectors responsible for pesticide regulation at MAPA, ANVISA, and IBAMA operates with resources below what's necessary to meet Brazilian agriculture's growing demand. MAPA, especially the Agricultural Defense Secretariat (SDA), Plant Health Division (DSV), and General Coordination of Pesticides and Related Products (CGAA), has faced challenges related to insufficient staff for years.

In 2024, ANVISA faced strikes, work stoppages, and complaints related to lack of resources and staff replacement, with numbers declining by about 47% between 2007 and 2024. This scenario compromises the agency's capacity to meet growing demands, resulting in work overload and delays in analyzing registrations for medications, chemical products, and pesticides, among others.

Since 2022, ANVISA's leadership has repeatedly warned the federal government about staff shortages, which directly impact process agility and other essential activities. Although the agency conducted a competition for 50 specialists in regulation and health surveillance in early 2024 and requested a new competition with 91 positions for 2025, the staff deficit persists, aggravated by the fact that more than half of current employees are eligible for retirement.

IBAMA also faced employee strikes and work stoppages in 2024, impacting various areas of the institution. To rebuild its staff, IBAMA took measures to hire new professionals. Although this initiative contributes to staff reconstruction, it covers only part of the open positions, indicating that the personnel deficit will persist.

Computerized Systems

Electronic submission of pesticide registrations in Brazil was gradually implemented over ten years ago, and during the COVID-19 pandemic, electronic registration analysis was consolidated at MAPA, ANVISA, and IBAMA.

An example of digitalization advances is the Optimized Reading Tool for Pesticide Registration (FLORA), developed by ANVISA to modernize and streamline the toxicological evaluation process for formulated products and equivalent products. FLORA's development began in 2019, and its solutions were gradually incorporated, using algorithms for systematized analysis of toxicological data, allowing faster and standardized evaluation.

In December 2024, ANVISA published Board Resolution (RDC) No. 950/2024, institutionalizing FLORA's use and establishing complementary requirements to optimize the analysis of petitions for evaluation and toxicological classification of formulated pesticides obtained from equivalent technical products.

Despite advances at MAPA, ANVISA, and IBAMA, the computerized systems are not connected, making coordination and information flow difficult during the analysis of products simultaneously submitted to all three bodies. This creates queues and delays, impacting analysis completion.

Law No. 14.785/23 provides for two systems to solve this problem:

1. Unified Computerized Registration and Use System for Pesticides and Environmental Control Products (Art. 22), which should integrate data from agronomic prescriptions, register producers, importers, and exporters, and connect to state and district inspection systems.

   
   

2. Unified Information, Petition, and Electronic Assessment System (SISPA) (Art. 58), which will allow coordination and synchronization of analyses by MAPA, ANVISA, and IBAMA, making the registration process more efficient and agile.

The new law didn't establish a deadline for implementing the Unified Registration System but determined that SISPA should be completed by December 28, 2024. However, due to system development complexity, lack of resources in the 2024 federal budget, and the need to involve various stakeholders, there's still no forecast for SISPA's first version launch.

Judicialization

After Law No. 14.785/23's enactment, the PSOL and PT political parties, along with the National Confederation of Agricultural Workers (CONTAG), filed Direct Actions of Unconstitutionality (ADIs) with the Supreme Federal Court (STF), questioning the constitutionality of certain provisions in the new law.

Although the project to modernize Law No. 7.802/89 was processed for more than 21 years in Congress and was approved by a large majority in both the Chamber of Deputies and Federal Senate, sectors of society opposed to the final text decided to contest it in court. The STF has not yet issued final decisions on these ADIs, which remain in the initial analysis phase.

(Editing by Leonardo Gottems, reporter for AgroPages)

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, Livestock and Food Supply (MAPA) of Brazil, will attend the 6th Biopesticides, Biostimulants and Biofertilizers Summit (BioEx 2025) in Shanghai on March 13-14, 2025, and deliver a keynote speech titled "Brazil's New Bioinputs Law: A New Regulatory Landscape for Sustainable Agriculture". BioEx 2025 welcomes your participation!