Brazil Regulatory News

In a significant move towards enhancing the safety assessment of pesticide products, the Brazilian Health Regulatory Agency, Anvisa, has introduced a user-friendly and entirely electronic pesticide in...

In a significant move towards enhancing the safety assessment of pesticide products, the Brazilian Health Regulatory Agency, Anvisa, has introduced a user-friendly and entirely electronic pesticide indication form. This innovative step aims to streamline the process of toxicological safety reassessment, making it more accessible and efficient for all stakeholders.

The new pesticide indication form marks a departure from the conventional paper-based submissions. Instead, it allows users to submit their suggestions electronically, eliminating the need to send documents via email. This transition to a fully electronic platform is expected to expedite the collection and evaluation of crucial data in the reassessment of pesticide active ingredients.

One of the primary objectives of the revised process is to compile a more robust risk matrix for ranking and selecting active ingredients that warrant re-evaluation. This initiative builds upon the last list of active ingredients for re-evaluation published in 2019, which prioritized seven compounds. Among these, the re-evaluation of carbendazim led to its eventual ban, underlining the significance of this endeavor in safeguarding public health.

Currently, four active ingredients are undergoing technical analysis by Anvisa, while two are awaiting the publication of a notice to commence re-evaluation. The revised pesticide indication form ensures that stakeholders, including representatives from the regulated sector and ordinary citizens, can contribute to the nomination process. However, it is important to note that providing technical-scientific information to support the suggested nominations is a prerequisite.

The toxicological reassessment of pesticides is a crucial post-market action undertaken by Anvisa to review the registration of products with potential health risks that were not initially identified during the registration process. Re-evaluation becomes necessary when there are concerns about the unacceptable risks posed by a particular active ingredient in a pesticide. The results of this re-evaluation can lead to various outcomes, including the suspension, ban, or maintenance of pesticide registrations, often with the adoption of health protection measures.

Anvisa invites all interested parties to contribute to the new matrix for selecting and prioritizing active ingredients for re-evaluation. This collaborative approach underscores the agency's commitment to ensuring the safety of pesticide products and protecting public health.

For those seeking further information on the toxicological re-evaluation process of pesticides, Anvisa's re-evaluation page provides comprehensive insights into the criteria used to prioritize active ingredients, the toxicological aspects evaluated, the complete list of active ingredients slated for re-evaluation, and much more.

This groundbreaking step by Anvisa in introducing a more accessible and efficient pesticide indication form promises to enhance the safety assessment of pesticide products, reinforcing the agency's dedication to safeguarding the health and well-being of the Brazilian population. Stakeholders are encouraged to actively engage in this important process to contribute to the ongoing improvement of pesticide safety standards.

More information at: Brazilian Health Regulatory Agency (Anvisa) — Agência Nacional de Vigilância Sanitária - Anvisa (www.gov.br)

Brazil has taken another big step in modernizing its chemical management regulations with the approval of the National Chemical Inventory Bill, PL 6120/2019. After years of rigorous evaluation and rev...

Brazil has taken another big step in modernizing its chemical management regulations with the approval of the National Chemical Inventory Bill, PL 6120/2019. After years of rigorous evaluation and revisions in various committees, the bill has received the green light from the final Committee (CCJC) in the Chamber of Deputies, marking a crucial milestone in ensuring the safety and sustainability of the nation's chemical industry. 

The approval of this text, which incorporates all the revisions made during its journey through different committees, reflects Brazil's commitment to enhancing chemical safety and environmental protection. The bill now advances to the Senate for further consideration, bringing the country one step closer to implementing a comprehensive chemical management system. 

The PL 6120/2019, is a testament to the country's dedication to establishing a robust regulatory framework for the chemical sector. 

It is important to highlight the foundation it provides for prioritization and subsequent risk assessment, which already exists within the bill. Brazil's approach to these aspects demonstrates its commitment to proactively managing chemical risks. 

The bill also addresses the role of foreign manufacturers in the Brazilian market. It introduces the concept of the "Exclusive Representative" (Only Representatives in Europe). This provision allows Brazilian entities to act as representatives of foreign manufacturers, embracing all obligations within Brazil. Additionally, it grants Brazilian importers the ability to facilitate foreign manufacturers' direct entry of information into the future chemical registration system, speeding the process. 

The approval of the PL 6120/2019 is not just a significant achievement for Brazil's chemical industry; it has broader implications for the country's international standing. This development underscores the importance of aligning with international standards and regulations and reinforces Brazil's commitment to becoming a responsible global player. 

In conclusion, the approval of Brazil's National Chemical Inventory bill in the Commitee (CCJC) represents a pivotal moment in the country's journey toward modernizing its chemical management regulations.  

It not only positions Brazil as a leader in the region but also aligns the nation with international standards, fostering greater safety, sustainability, and transparency in the chemical industry.  

Brazil's regulatory landscape has embraced recent technological advancements in the registration of microbiological products. The SDA/Mapa - Ibama - Anvisa Joint Ordinance No. 1/2023, a recent pub...

Brazil's regulatory landscape has embraced recent technological advancements in the registration of microbiological products. The SDA/Mapa - Ibama - Anvisa Joint Ordinance No. 1/2023, a recent publication, has supplanted Joint Normative Instruction No. 3/2006, outlining the procedures governing the registration of microbiological products utilized in pest control, defoliation, desiccation, growth stimulation, and inhibition.

Microbiological inputs, derived from fungi, bacteria, and viruses, represent natural adversaries against various agricultural pests and diseases. Many of these products are born of biotechnology, a field in constant technological flux and expansion.

The new Joint Ordinance is designed to harmonize legislation with recent innovations. It introduces notable changes such as permitting the registration of inactivated microorganisms (previously limited to live ones) and regulating the registration of biostimulants, metabolites, and genetically modified organisms. This regulatory overhaul also seeks to streamline bureaucratic processes while elucidating various aspects of product registration.

These updated regulations align with developments in the biological agricultural inputs sector, offering greater transparency for both industries and regulatory bodies. Many of the emerging technologies were not covered by previous legislation.

It's crucial to emphasize that registrations will continue to undergo scrutiny from Anvisa (National Health Surveillance Agency), Ibama (Brazilian Environment Institute), and Mapa (Ministry of Agriculture and Livestock). However, the new regulations aim to expedite the process. Previously, registration of a biological product could take up to three years, but with these changes, the average duration is expected to be reduced to one year.

By reducing bureaucratic hurdles, the goal is to accelerate the registration of microbiological products, enabling them to enter the market more swiftly. It's important to note that product safety and efficacy will continue to undergo rigorous evaluation, ensuring the protection of public health and the environment. The ordinance provides legal certainty for companies and establishes clear quality control parameters, which were previously lacking, marking a significant milestone for the sector.

These regulations enhance the confidence of producers and consumers in the efficacy and safety of agricultural products used in Brazil, fostering greater sustainability and balance in the industry.

Brazil has been actively promoting the registration of microbiological products for pest control, evidenced by the increasing number of registrations in recent years. In 2023 alone, 33 low-impact products received registration.

Expectations are high that this new regulatory framework will further stimulate innovation and the development of novel agricultural microbiological inputs, contributing to a more responsible and regenerative agricultural landscape in Brazil.

Brazil's National Health Surveillance Agency (ANVISA) has recently made revisions to its roster of approved active ingredients found in pesticides, sanitizing disinfectants, and wood preservatives...

Brazil's National Health Surveillance Agency (ANVISA) has recently made revisions to its roster of approved active ingredients found in pesticides, sanitizing disinfectants, and wood preservatives.

These latest changes, officially unveiled on September 4th, build upon ANVISA's prior regulatory guidance outlined in Normative Instruction N° 103 of October 19, 2021, which laid out the authorized active components in these product categories.

ANVISA maintains a dynamic list, routinely subject to updates, with the most recent alterations encompassing the inclusion of the subsequent substances:

Flucarbazonesodium, Fluindapyr, Ipflufenoquin, Isocycloseram, Penflufen, Tetradecadiena, Tolpyralate.

These revisions came into immediate effect upon their publication.

Published on September 1st, Resolution RDC No 813/2023 supersedes the previous May 2022 resolution, RDC No 698/2022. While a significant portion of the 2022 requirements remains intact, this new regul...

Published on September 1st, Resolution RDC No 813/2023 supersedes the previous May 2022 resolution, RDC No 698/2022. While a significant portion of the 2022 requirements remains intact, this new regulation brings updates to the documentation necessary for manufacturers, importers, and distributors when registering bleach sanitizing products.

Moreover, the revised resolution segments labeling standards into two distinct sections, underscoring the mandatory safety language requirements.

These changes are set to take effect on September 13th, marking a crucial update in the regulation of bleach sanitizing products in Brazil.

Brazil is set to make significant strides in its chemical regulatory landscape with the reinstatement of the National Commission on Chemical Safety (CONASQ). This move, initiated by President Lula'...

Brazil is set to make significant strides in its chemical regulatory landscape with the reinstatement of the National Commission on Chemical Safety (CONASQ). This move, initiated by President Lula's administration, demonstrates a commitment to modernize chemical management in the country. The revival of CONASQ, which was disbanded in 2019, signifies a pivotal moment for Brazil, positioning it as a leader in Latin America's chemical regulatory efforts.  

CONASQ, prior to its dissolution in 2019, was a model of collaborative governance. Comprising representatives from government agencies, academia, non-governmental organizations (NGOs), and industry associations, the commission facilitated an interdisciplinary and multi-stakeholder approach to chemical safety. Under the leadership of the Ministry of Environment, CONASQ aimed to develop a robust framework for industrial chemical policy, with the goal of presenting a bill to Congress. 

The commission worked diligently over several years, drawing inspiration from regulatory models in the European Union. By 2018, they had prepared a comprehensive draft that, if enacted, would have established Brazil as the first major economy in Latin America to adopt such progressive chemical regulation. 

However, the dissolution of CONASQ put these efforts on hold. In response, a Congressman introduced a less comprehensive bill in the Chamber of Deputies in 2019. This bill, known as PL 6120/2019, provided a foundation for those advocating for a new chemical management system. Interestingly, this version would later be entirely replaced by another bill heavily influenced by the original CONASQ draft from 2018.  

The Significance of PL 6120/2019 

PL 6120/2019 represents Brazil's version of a national chemical regulation. It outlines key components such as the establishment of a hazardous chemical registry, rules for chemical prioritization, risk assessment, and risk management. This legislation is pivotal for enhancing chemical safety, protecting public health, and promoting environmental sustainability in Brazil. 

The Implications of CONASQ's Revival 

The reinstatement of CONASQ signals a positive shift in Brazil's approach to chemical management. It sets the stage for a modernized regulatory infrastructure that aligns with international standards and best practices. This move is also likely to be well-received by officials from the Organization for Economic Cooperation and Development (OECD), who have been actively considering Brazil for accession. 

CONASQ's thought leadership and expertise will not only benefit Brazil but also play a crucial role in regional efforts for regulatory collaboration. Neighboring countries will have access to a valuable resource as they work towards enhancing chemical safety and harmonizing regulations across Latin America. 

The revival of the National Commission on Chemical Safety (CONASQ) in Brazil is a significant step towards establishing a modern chemical management system in the country. With the reintroduction of this respected council, Brazil is poised to lead the way in Latin America's chemical regulatory landscape. PL 6120/2019, inspired by CONASQ's work, promises to bring about essential reforms in chemical safety and management. 

As Brazil looks ahead to a future with strengthened chemical regulations, it positions itself as a responsible and forward-thinking player in global chemical management efforts. This development is not only a win for Brazil but also a promising sign for regional collaboration and harmonization of chemical regulations across Latin America. 

Brazil's health regulatory agency, ANVISA recently announced a proposal to amend Resolution RDC 778/2023, which governs food additives and adjuvants in food technology. This proposed resolution s...

Brazil's health regulatory agency, ANVISA recently announced a proposal to amend Resolution RDC 778/2023, which governs food additives and adjuvants in food technology. This proposed resolution seeks to establish a maximum tolerable residual limit for ethylene oxide in food additives, aiming to enhance consumer protection.

Ethylene Oxide Regulation

The proposed amendment to RDC 778/2023 introduces a crucial regulation concerning ethylene oxide levels in food additives. Specifically, it sets a maximum tolerable residual limit of 0.01 mg/kg for ethylene oxide in food additives. Ethylene oxide is a chemical used in various industrial processes, and its presence in food additives must be carefully controlled to ensure consumer safety.

Exceptions for Certain Food Additives

While the proposed regulation imposes strict limits on ethylene oxide, it includes exceptions for specific food additives. These exceptions apply to food additives that comply with the identity, purity, and composition specifications established by JECFA (Joint FAO/WHO Expert Committee on Food Additives) or FCC (Food Chemicals Codex). The listed food additives exempt from the maximum tolerable residual limit are as follows:

1. Polyoxyethylene (20) sorbitan monolaurate, polysorbate 20, INS 432
2. Polyoxyethylene (20) sorbitan monooleate, polysorbate 80, INS 433
3. Polyoxyethylene (20) sorbitan monopalmitate, polysorbate 40, INS 434
4. Polyoxyethylene (20) sorbitan monostearate, polysorbate 60, INS 435
5. Polyoxyethylene triestearate (20) sorbitan, polysorbate 65, INS 436
6. Grafted copolymer of polyvinyl alcohol (PVA) and polyethylene glycol (PEG), INS 1209
7. Polyethylene glycol, INS 1209

These additives, when meeting the specified criteria, will not be subject to the ethylene oxide limit, ensuring that they continue to be safe for consumption.

Public Consultation

ANVISA has initiated a public consultation period to gather feedback and comments from stakeholders and the general public. Interested parties are encouraged to submit their comments and suggestions regarding this proposed regulation within 45 days of the issuance of the public notice, which was posted on August 23, 2023. 

Ensuring Food Safety

The proposed regulation of ethylene oxide in food additives underscores ANVISA's dedication to ensuring the safety and quality of food products in Brazil. By setting a clear limit and providing exceptions for additives meeting stringent criteria, ANVISA aims to protect consumers from potential health risks associated with ethylene oxide exposure.

This important regulatory change reflects ANVISA's ongoing efforts to adapt and enhance food safety standards, aligning with international best practices while considering the unique needs of the Brazilian population. To submit your comments and engage in the public consultation process, visit ANVISA's official website.