Brazil Revolutionizes Pesticide Regulation with Landmark Law

Editor’s note: After a prolonged gestation period of 24 years in Brazil's legislative chambers, Law No. 14.785, colloquially known as the new Pesticide Law, has finally seen the light of day. This landmark legislation promises to reshape the landscape of pesticide registration and management in one of the world's agricultural powerhouses. As Brazil transitions from being a net importer to one of the largest exporters of livestock and agricultural products, this regulatory overhaul carries significant implications for the country's agrochemical industry and its global competitiveness.

I recently had the privilege of interviewing leaders from prominent consulting firms about Brazil's new pesticide registration regulations. The insights from Mariana Lima, Regulatory Affairs Manager at Staphyt Brazil; João Pontin, Director Associate at Lemma Agro, and Erika Lopes Sordi, Founder of Sordi AgroConsulting provide a comprehensive view of the changes and their potential impacts. This article aims to present a balanced perspective on this significant regulatory shift in Brazil's agrochemical sector, exploring its implications for the industry, farmers, and the broader agricultural landscape.

Centralization of Registration Process

Perhaps the most significant change introduced by the new law is the centralization of the registration process under the Ministry of Agriculture, Livestock, and Supply (MAPA). João Pontin of Lemma Agro emphasized this point, stating, "MAPA becomes the coordinator for the bill enforcement." This shift represents a departure from the previous system where responsibilities were divided among different agencies, often leading to delays and inconsistencies in the registration process.

Mariana Lima of Staphyt Brazil elaborated on this change: "The responsibility for product registration passes to the Ministry of Agriculture with all analyzes carried out by the Ministry of the Environment and the Ministry of Health." This centralization aims to streamline the process, potentially reducing the time and bureaucracy involved in pesticide registration.

However, it's important to note that this centralization doesn't mean the exclusion of other relevant agencies. The Brazilian Institute of the Environment and Renewable Natural Resources (IBAMA) and the National Health Surveillance Agency (ANVISA) will still play crucial roles in the evaluation process, particularly in their respective areas of expertise. The new system aims to create a more coordinated approach rather than a siloed one.

New Registration Deadlines

One of the most anticipated changes in the new law is the introduction of specific deadlines for the analysis of registration processes. Mariana Lima provided a detailed breakdown of these new timelines:

- 24 months for new formulated or technical products

- 60 days for identically formulated products

- 30 days for Temporary Special Registration (EUP)

- 12 months for other products (generic products, equivalent products, etc.)

- 30-180 days for post-registration changes

These new deadlines represent a significant shift from the previous system, where registration processes could drag on for years without a clear timeline. Erika Lopes Sordi of Sordi AgroConsulting expressed optimism about this change, stating, "We expect to have the approval faster than before as we have new deadlines proposed by Government and they are committed in reduce the bureaucracy for some types of registration."

However, Sordi also highlighted a potential challenge in meeting these new timelines: "The main challenges to achieve the deadlines is the technical team in the Government as we know they do not have enough technical team to evaluate the large number of processes in the queue." This raises questions about the government's capacity to handle the increased workload within the specified timeframes.

Risk-Based Approach to Product Registration

Another significant change introduced by the new law is the shift towards a risk-based approach for product registration. This aligns Brazil's regulatory framework more closely with international standards, particularly the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

Lima explained that "The Risk Assessment becomes mandatory for registrations of new products and changes in uses that involve dose increase, inclusion of culture, application equipment or reanalysis." She further elaborated that this approach "shows the realistic scenario of the product, bringing more technical safety, becoming possible registration of products with mitigable risk."

This shift from a hazard-based to a risk-based approach represents a significant change in how pesticides are evaluated. It allows for a more nuanced assessment that considers not just the inherent properties of a substance but also the likelihood and extent of exposure under real-world conditions.

Pontin from Lemma Agro added, "Everyone benefited from this learning process. For sure it is not a perfect world, much improvement is expected from all players, but always each one, keeping in mind to do the best for the main aim of bringing quality and safe products to the market, with quality and safe food for local and all the world."

Agronomic Feasibility Studies

The new law introduces a requirement for agronomic feasibility studies for certain formulated products. Lima pointed out that "efficacy tests are now required for all products with different formulations than those already registered." This change is expected to provide more assurance to farmers about product efficacy but may also increase costs for companies.

Sordi noted that "If on the one hand, this change will bring more safety to the producer with respect to product efficiency, on the other hand, there will be a greater cost for companies in conducting field trials that must be conducted exclusively in Brazil."

Two-Year Production Limit

One of the more controversial aspects of the new law is the requirement for companies to begin production and commercialization within two years of receiving registration approval. Lima explained, "The Law establishes a period of up to 2 (two) years for the beginning of production and marketing of products, from the issuance of the product registration, under penalty of cancellation of the registration granted."

This provision aims to address the issue of companies obtaining registrations without actually bringing products to market. Sordi highlighted the potential impact: "This article is not clear if it is about Technical and Formulated product, for example and also the quantity of product that can characterize commercialization."

This requirement could significantly impact companies' strategies, potentially leading to a more dynamic market but also raising concerns about rushed commercialization.

Environmental and Health Impacts

The interviewees generally expressed optimism about the potential environmental and health impacts of the new regulations. Lima stated, "With the new approach to environmental risk assessment and management, the expected impacts are positive, since mitigation measures will be easier to apply."

However, it's important to note that the effectiveness of these measures will depend on their implementation and enforcement. The shift to a risk-based approach allows for more nuanced decision-making but also requires robust assessment capabilities and ongoing monitoring.

Pontin emphasized the importance of balancing agricultural productivity with environmental and health concerns: "Due to disease some crops may have 100% of losses yield (potato, soybean and tomato), 100% as well with pests (peanut and cotton)." This underscores the need for effective pest management solutions while also ensuring safety and sustainability.

Global Competitiveness

There's a consensus among the interviewees that these changes could enhance Brazil's competitiveness in the global agrochemical market. Sordi believes that "more companies will be interested in Brazilian market as we know that time is one of the main challenges in Brazil registration."

Pontin echoed this sentiment, stating that the new law provides "a predictable timeline to enter into market, instead of getting registration when the product has no more market fit. This will help companies to better understand and plan investments, as well as to project a real return on local project investments, characterizing a more friend environment to be part of."

However, increased competitiveness also means increased competition. The potential influx of new products could lead to price pressures and market consolidation, which companies will need to navigate carefully.

Challenges and Areas for Clarification

Despite the generally positive reception, the interviewees highlighted several areas that require further clarification or potential adjustment:

Implementation capacity: Sordi raised concerns about the government's capacity to handle the increased workload within the new timelines.

Commercialization requirement: The specifics of the two-year production limit, including what constitutes "commercialization" and how it applies to different product types, need clarification.

Risk assessment guidelines: Lima noted that "Some criteria and guidelines for the Operator Risk Assessment and for Non-target Populations still need to be established by the National Health Surveillance Agency (ANVISA)."

State-level regulations: The new law may impact state-level registration procedures, which Pontin mentioned are "under review and may have new procedures."

Efficacy trials: The requirement for efficacy trials for products with different formulations may need further guidelines to ensure consistency and fairness.

Advice for Companies

The interviewees offered valuable advice for companies navigating this new regulatory landscape:

Understand local needs: Sordi emphasized the importance of understanding "field reality in Brazil and exactly what farmers needs according to region and crops as much as possible."

Focus on quality: Both Sordi and Pontin stressed the importance of conducting high-quality studies and preparing thorough registration dossiers to avoid delays.

Build reliable partnerships: Pontin advised companies to "select reliable partners that for sure will guarantee the company achievements as planned, in a win-win process."

Stay informed: Given the evolving nature of the regulations, companies should stay abreast of any clarifications or adjustments to the law.

Consider market dynamics: With the potential for increased competition, companies should carefully consider their market entry strategies and product positioning.

Time Is the Test of Success

Brazil's new Pesticide Law represents a significant shift in the country's approach to agrochemical regulation. By centralizing the registration process, introducing specific timelines, and adopting a risk-based approach, the law aims to modernize and streamline pesticide registration while maintaining necessary safeguards for health and the environment.

The changes promise to make Brazil more attractive to international agrochemical companies and potentially increase the availability of new technologies for Brazilian farmers. However, they also introduce new complexities and potential challenges that all stakeholders will need to navigate carefully.

As Pontin aptly put it, "Above all, the scenario players must seek the best for the country even seeking to improve its GDP (Gross domestic product), bringing better life quality and fairness to the Brazilian population as well as for the countries that have access to Brazilian agricultural production."

The coming months and years will be crucial in determining whether this regulatory overhaul truly represents a step forward for Brazil's agrochemical industry. Success will depend not only on the letter of the law but also on its implementation, the capacity of regulatory bodies to adapt, and the responsiveness of the industry to the new requirements.

As Brazil continues to cement its position as a global agricultural powerhouse, the implications of this new law will likely extend far beyond its borders, potentially influencing regulatory approaches in other major agricultural nations. For now, all eyes are on Brazil as it embarks on this new chapter in agrochemical regulation.

This story was initially published in the 2024 Latin America Focus. Download the magazine to read more stories.

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