Brazil Regulatory News

The MMA (Ministry of Environment of Brazil) is calling for non-governmental entities to join their National Commission for Chemical Safety (Conasq). Published on Monday (Nov 13th), this notice invite...

The MMA (Ministry of Environment of Brazil) is calling for non-governmental entities to join their National Commission for Chemical Safety (Conasq).
Published on Monday (Nov 13th), this notice invites organizations from civil society, the private sector, academia, and professional entities to be a part of this crucial commission. The deadline for registration is November 24th!
The Conasq is dedicated to fostering integrated actions for the environmentally responsible management of chemical products. Its mission is to proactively address health and environmental risks associated with these substances. By promoting the safe use of chemicals, the commission aims to minimize their presence in consumer products while advocating for safer alternatives.
Brazil is making strides towards a safer and healthier future!

The President of Ibama (Brazilian Institute of environment) has issued a groundbreaking resolution regarding the control of Hydrofluorocarbons (HFCs) imports.  The resolution outlines stringent me...

The President of Ibama (Brazilian Institute of environment) has issued a groundbreaking resolution regarding the control of Hydrofluorocarbons (HFCs) imports. 

The resolution outlines stringent measures to regulate the importation of HFCs and HFC-containing mixtures. This action is taken in compliance with the Kigali Amendment of the Montreal Protocol on Substances that Deplete the Ozone Layer. 

The key provisions of the resolution include: 

• Definition of Terms: The resolution provides comprehensive definitions, including those for substances that deplete the ozone layer (SDO), the Montreal Protocol, Global Warming Potential (GWP), ton of CO2 equivalent, and various categories related to HFCs. 

• Import Quotas: The resolution establishes a quota system for the import of HFCs, delineating annual maximum limits in CO2 equivalent tons. These quotas are assigned based on various criteria, including the importer's historical activities and the type of HFCs involved. 

• Control Mechanisms: Companies involved in importing HFCs are required to submit electronic forms detailing their activities by April 30 of the subsequent year. Failure to provide accurate information will result in penalties. 

• Reduction Targets: The resolution outlines a phased reduction in the national quota for HFC imports, with a freeze for the year 2024 and subsequent annual reductions from 2029 onwards. 

• Performance and Technical Reserves: The national quota will be divided into performance and technical reserves, ensuring responsible import practices. The technical reserve is set aside for new market entrants and those who have exhausted their specific quota. 

• Utilization of Quotas: Importers must adhere to strict procedures for utilizing their quotas, including registration with Ibama and the Unique Foreign Trade Portal. The resolution emphasizes the importance of accurate information and compliance with the stipulated regulations. 

• Transfer of Quotas: The resolution permits the transfer of quotas between companies under specific conditions, subject to Ibama approval. This measure aims to foster collaboration and responsibility within the industry. 

• Cessation of Import: Companies choosing not to utilize their import quotas for two consecutive years will have their quotas permanently transferred to the technical reserve. 

This landmark resolution reflects Brazil's commitment to international environmental agreements and signals a proactive approach to mitigating the impact of HFCs on the ozone layer and global warming.  

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.