Brazil Regulatory News

The trade bloc of South America (Mercosur) has released a preliminary regulatory proposal aimed at modernizing the roster of permissible additives for food contact materials. Should the proposal g...

The trade bloc of South America (Mercosur) has released a preliminary regulatory proposal aimed at modernizing the roster of permissible additives for food contact materials.

Should the proposal gain approval, it would result in an update to technical regulation No 02/12. The key addition would be the inclusion of tetramethyl bisphenol F diglycyl ether in the 'positive list' for food contact materials, which specifies authorized plastics and polymeric coatings.

Additionally, the proposal would impose restrictions on the use of polyamide-imide 2, confining it to being a binding agent exclusively for high-temperature resistant cookware.

For these changes to become legally binding in each of the Mercosur countries, namely Argentina, Brazil, Paraguay, and Uruguay, they would need to integrate this standard into their national legislations.

Interested parties are invited to submit their comments on the proposal by the 30th of October.

ANVISA; Brazil's National Health Surveillance Agency routinely revises its router of approved active ingredients in pesticides, sanitizing disinfectants, and wood preservatives. The updated guideline...

ANVISA; Brazil's National Health Surveillance Agency routinely revises its router of approved active ingredients in pesticides, sanitizing disinfectants, and wood preservatives. The updated guidelines, which were made public on the 26th and 27th of September, represent an amendment to ANVISA's earlier directive (No. 103, dated 19th October 2021) that outlined the sanctioned active components for these products. Modifications to the specifications encompass a range of adjustments, such as alterations in concentration thresholds and the inclusion of specific product applications.

The September update notably modified the specifications of almost thirty substances, including Ammonium glufosinate, benzovindiflupyr, buprofezin, ciproconazole, difenoconazole, emamectin benzoate, indoxacarb, isocycloseram, paenibacillus, pyraclostrobin, spiropidion, and zeta-cypermethrin.

The revised regulations came into immediate effect.

In a considerable move towards combating climate change and protecting the environment, Brazil has enacted the Kigali Amendment to the Montreal Protocol on Substances that Deplete the Ozone Layer. Th...

In a considerable move towards combating climate change and protecting the environment, Brazil has enacted the Kigali Amendment to the Montreal Protocol on Substances that Deplete the Ozone Layer. This milestone was achieved through Decree No. 11.666 in August, and it marks a vital step in addressing the high potential of Hydrofluorocarbons (HFCs) to intensify global warming. HFCs may not deplete the ozone layer, but their contribution to climate change cannot be ignored.

The Kigali Amendment, named after the Rwandan city where it was adopted in 2016, is an extension of the Montreal Protocol, which has been hailed as one of the world's most successful environmental agreements. The original Montreal Protocol focused on phasing out ozone-depleting substances (ODS) like chlorofluorocarbons (CFCs) and halons. Its remarkable success in achieving its goals has been pivotal in protecting the Earth's ozone layer.

However, as the world reduced its use of ODS, there was a surge in the production and consumption of HFCs, hydrochlorofluorocarbons (HCFCs), and other related compounds. These chemicals, used primarily in air conditioning, refrigeration, and other applications, are potent greenhouse gases, with global warming potentials thousands of times greater than carbon dioxide (CO2).

The Kigali Amendment, therefore, aims to address this unintended consequence by phasing down the production and consumption of HFCs. Signatories to the Montreal Protocol are required to reduce their HFC usage over time, ultimately leading to a significant reduction in their contribution to global warming.

Brazil's Commitment to the Kigali Amendment

Brazil's commitment to combating climate change has taken another step forward with the enactment of the Kigali Amendment. By aligning with the goals of the amendment, Brazil acknowledges the importance of mitigating the impacts of HFCs on the climate.

To implement the Kigali Amendment domestically, Brazil's environmental agency, the Brazilian Institute of the Environment and Renewable Natural Resources (Ibama), will play a pivotal role. Ibama will publish a Normative Instruction (IN) that will establish the requirements and procedures related to the import control of HFCs and mixtures containing HFCs. This regulation will set annual import limits in compliance with the Protocol, ensuring that Brazil meets its obligations under the Kigali Amendment.

Public Engagement and Transparency

Ibama's commitment to transparency and public participation is commendable. The Institute has announced its intention to open a public consultation on the Normative Instruction (IN) through the Participa + Brasil platform. This initiative allows all interested sectors, including industry, environmental organizations, and the public, to access the proposal and make their contributions on the subject. This inclusive approach ensures that a wide range of perspectives and expertise are considered in the development of the regulation, promoting fairness and effectiveness in its implementation.

More info in Portuguese about it: Ibama informa sobre Implementação da Emenda de Kigali para controle dos HFCs no Brasil — Ibama (www.gov.br)

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.