Brazil Regulatory News

Brazil’s National Health Surveillance Agency (Anvisa) has opened Public Consultation No. 1,313, seeking public input on a proposed Normative Instruction that defines how companies must transmit and...

Brazil’s National Health Surveillance Agency (Anvisa) has opened Public Consultation No. 1,313, seeking public input on a proposed Normative Instruction that defines how companies must transmit and manage data under the Unique Device Identification (UDI) system for medical devices. Contributions can be submitted until May 26, 2025.

Background: What Is RDC No. 591/2021?

The consultation stems from Collegiate Board Resolution (RDC) No. 591, issued in December 2021, which introduced Brazil’s UDI framework for medical devices. The regulation aims to enhance the traceability, safety, and post-market surveillance of medical products by requiring that each device be assigned a unique identifier.

RDC 591/2021 mandated that UDI data must be transmitted to a centralized Anvisa database, but the obligation would only begin once Anvisa officially confirmed that its system was ready to receive such data.

Why This Public Consultation?

Public Consultation No. 1,313 fulfills that requirement. It:

• Announces that Anvisa’s UDI database (SIUD) is now operational and capable of receiving UDI data.

• Presents a draft Normative Instruction detailing the technical and procedural requirements for transmitting this data.

• Invites stakeholders—such as manufacturers, importers, and healthcare entities—to review and comment on the proposed framework before it is finalized.

Key Elements of the Draft Normative 

The Normative Instruction establishes:

• Two methods for UDI data transmission: individual or bulk submission.

• Company responsibilities, including the option to authorize third-party users to submit data on their behalf.

• Rules for data modification, publication, and device discontinuation.

• A timeline for mandatory compliance, based on the risk classification of each medical device as outlined in RDC 591/2021.

Devices already on the market may have their UDI data submitted voluntarily, even before mandatory deadlines apply.

How to Participate

Comments can be submitted via Anvisa Portal: Contribution Form

Submissions are public and will be available for review after the consultation closes.  Once the consultation period ends, Anvisa will analyze the input and publish the final version of the Normative Instruction, which is expected to take effect on July 1, 2025. The agency also plans to release detailed implementation guides and a user manual for the SIUD system.

This marks a significant step toward strengthening Brazil’s regulatory infrastructure for medical devices and aligning with international best practices for UDI implementation.

The Brazilian National Commission on Chemical Safety (CONASQ) has approved a proposal to restrict the use of hazardous substances in electronic and electrical products. This decision was reached durin...

The Brazilian National Commission on Chemical Safety (CONASQ) has approved a proposal to restrict the use of hazardous substances in electronic and electrical products. This decision was reached during a meeting, held on February 25 at the Ministry of the Environment and Climate Change (MMA) headquarters in Brasília.

Drafted by the Temporary Working Group on the Restriction of Hazardous Substances (GTT-RoHS), the proposed resolution will now be reviewed by the National Environmental Council (Conama).The targeted hazardous substances, including heavy metals, flame retardants, and plasticizers, are commonly found in electronic waste such as mobile phones, computers, and kitchen appliances. Due to their risks to human health and the environment, they are to be replaced with safer alternatives.

Additional Measures

The meeting of CONASQ brought together representatives from the federal government, civil society, and industry. The commission also voted to extend the mandate of the Working Group on Chemicals in Plastics, which contributes to discussions on the development of an international treaty to combat plastic pollution—a matter still under negotiation among nations.

Other topics addressed during the meeting included the National Program for the Reduction of Pesticides (Pronara) and an updated National Diagnosis for the National Plan for Prevention, Preparedness, and Rapid Response to Environmental Emergencies Involving Hazardous Chemical Products (P2R2). Additionally, a permanent working group was established to oversee this initiative. The next CONASQ plenary meeting is scheduled for June.

On February 20, 2025, Brazil officially launched the "Environmental Monitoring Strategy for PFOS and Pesticides," a groundbreaking initiative to track pesticide contamination and enhance public health...

On February 20, 2025, Brazil officially launched the "Environmental Monitoring Strategy for PFOS and Pesticides," a groundbreaking initiative to track pesticide contamination and enhance public health. This strategic program is a collaboration between the Brazilian Ministry of Environment and Climate Change (MMA), the Brazilian Agricultural Research Corporation (Embrapa), and the Brazilian Institute of Environment and Renewable Natural Resources (Ibama). The initiative focuses on systematically collecting data on persistent pollutants like PFOS, a toxic chemical linked to pesticide use.

Key Objectives of Brazil’s Pesticide Monitoring Initiative

Spanning a three-year period, the environmental monitoring strategy aims to track the presence of 53 active pesticide ingredients across Brazil. By analyzing contamination levels, the program will:

• Strengthen public policies for environmental protection and human health.

• Ensure agricultural sustainability by promoting responsible pesticide use.

• Align Brazil’s agricultural industry with international environmental regulations.

PFOS (perfluorooctane sulfonate) is particularly concerning due to its persistence in the environment and accumulation in living organisms. As a globally recognized pollutant, monitoring its presence will help mitigate risks and support cleaner agricultural practices.

Advancing Sustainable Agriculture in Brazil

This initiative represents a significant step toward ensuring sustainable agricultural practices and food safety. By closely tracking pesticide residues, Brazil is reinforcing its commitment to balancing economic growth with environmental responsibility. The collected data will:

• Enhance the quality and safety of agricultural products.

• Support compliance with global environmental standards, such as the Stockholm and Rotterdam Conventions.

• Improve the sustainability of Brazil’s agricultural exports by aligning with stringent international pesticide regulations.

Brazil’s Commitment to Global Environmental Standards

Led by Embrapa Meio Ambiente, the research division of Embrapa, the study is funded by the MMA and builds on previous agro-environmental monitoring efforts. The initiative aligns with global agreements regulating persistent organic pollutants and ensures Brazil remains competitive in the international agricultural market.

Strengthening Brazil’s Environmental Monitoring Capabilities

Brazil’s launch of the "Environmental Monitoring Strategy for PFOS and Pesticides" marks a major milestone in environmental sustainability. By improving pesticide management, strengthening food safety, and supporting global trade competitiveness, the initiative will drive long-term benefits for public health, ecosystems, and Brazil’s agricultural sector. For more details you can consult the news (in Portughese) here. 

The National Health Surveillance Agency (ANVISA) has published on the 6th of February 2025, Resolution RDC No. 961/2025, amending Resolution RDC No. 56/2012 regarding the list of authorized monomers,...

The National Health Surveillance Agency (ANVISA) has published on the 6th of February 2025, Resolution RDC No. 961/2025, amending Resolution RDC No. 56/2012 regarding the list of authorized monomers, initiator substances, and polymers for use in plastic packaging and equipment intended for food contact. The list of monomers and other authorized substances contained in Part I and the list of authorized polymers contained in Part V of the Annex of the Resolution 56/2012 shall come into force with the addition of the substances contained in Annex I and Annex II of this Resolution. 

The new resolution, approved by ANVISA’s Collegiate Board of Directors, incorporates provisions from GMC/MERCOSUR Resolution No. 28/2024 into Brazil’s legal framework.

Key Changes in RDC No. 961/2025

Annex I: Expansion of Authorized Monomers and Initiator Substances:

The resolution adds Tetramethyl Bisphenol F Diglycidyl Ether (TMBPF-DGE) (CAS No. 113693-69-9) to the list of authorized monomers and initiator substances.

• Specific migration limits (LME) have been established for TMBPF-DGE and its derivatives
• Its use is restricted to macromolecular substance dispersions in water for beverage can coatings.

Annex II: Inclusion of a New Authorized Polymer:

• Polyamide-imide 2 (PAI-2) (poly-N-(4,4'-diphenylmethane trimellitamide imide)) has been added to the list of authorized polymers.
• This polymer, produced from 4,4'-diaminodiphenylmethane and benzoyl-3,4-dicarboxylic anhydride chloride, is permitted for use as a binder in coatings for high-temperature-resistant kitchen utensils.
• Restrictions include:
  • Maximum coating thickness of 60 µm.
  • Safe usage at temperatures up to 230°C, or up to 250°C for short durations (15 minutes max).

Regulatory Impact and Industry Implications

The amendments provide manufacturers with additional material options while maintaining stringent safety and compliance standards for food contact applications.

Effective Date

RDC No. 961/2025 comes into effect immediately upon publication in the Diário Oficial da União on February 6, 2025. For more details, you can consult the full resolution here (in Portughese). 

The Brazilian Health Regulatory Agency (Anvisa) has revised its pesticide evaluation guidance for mutagenicity, carcinogenesis, neurotoxicity, and reproductive toxicity.   Purpose of the Updat...

The Brazilian Health Regulatory Agency (Anvisa) has revised its pesticide evaluation guidance for mutagenicity, carcinogenesis, neurotoxicity, and reproductive toxicity.

Purpose of the Updated Guidelines

These guides are critical resources for assessing the toxicological concerns associated with pesticides. They provide recommended practices and methodologies for the analysis of different outcomes, ensuring a rigorous and thorough review process throughout product registration and future re-analysis.

Alignment with Scientific Advances and Legislation

Anvisa emphasises that these guidelines represent its understanding of current best practice and are in line with the latest scientific advances and regulatory requirements. The updates incorporate comments from public discussions and align with recent amendments to Brazilian pesticide regulation (Law 14,785 of December 27, 2023).

Objectives of the Revisions

The main objective of these revised guidance is to improve the transparency and clarity of the toxicological evaluation standards, especially throughout the re-analysis process.
The updated guidance is effective immediately.

Highlights of the Update

• Guidelines on pesticide mutagenicity, carcinogenesis, neurotoxicity, and reproductive toxicity have been updated.

• Improved transparency and clarity of the evaluation process.

• Included comments from public consultations and aligned with new legislative developments.

Anvisa’s Role in Pesticide Evaluation

Anvisa is responsible for the evaluation of pesticides, environmental control products, technical products, and related items in accordance with its objective of promoting and protecting the health of the Brazilian population.

Pesticide Registration and Re-Analysis

Unlike other products controlled by the Agency, the registration of pesticides is not legally subject to renewal or revalidation, and it is permanent. However, pesticides are subject to re-analysis to ensure product safety and limit possible damage. International or domestic organizations can request re-analysis.

Since 2006, Anvisa has carried out 19 re-evaluations of pesticides and is currently carrying out four re-analyses. The provision of updated instructions will increase transparency in the evaluation of these products.

*Source

On November 13, 2024, Brazilian President Lula sanctioned Law 15.022/24, previously known as PL 6120/24, establishing the National Inventory of Chemical Substances. This law establishes a comprehensiv...

On November 13, 2024, Brazilian President Lula sanctioned Law 15.022/24, previously known as PL 6120/24, establishing the National Inventory of Chemical Substances. This law establishes a comprehensive framework for effective risk assessment and management of chemical substances in Brazil. Previously, Brazil regulated chemicals through sector-specific laws covering areas such as pharmaceuticals, cosmetics, pesticides, sanitizing products, and explosives. With this new law, Brazil joins a select group of countries with advanced systems for monitoring chemicals entering its market and assessing risks to human health and the environment.  

At the core of the law is the National Inventory of Chemical Substances, a tool designed to assess and control the risks associated with chemical substances used, produced or imported into the national territory. Its main objective is to minimize adverse effects on health and the environment.  

This milestone is the result of collaboration between several Brazilian stakeholders, including the Ministry of the Environment and Climate Change (Ministério do Meio Ambiente e Mudança do Clima), the Brazilian Chemical Industry Association (Abiquim) and the National Chemicals Safety Commission (Conasq).  

Regulations are expected to be published in early 2025 that will further elaborate on key elements of the law. One such regulation is expected to define the operational framework of the Committees responsible for overseeing the evaluation of chemical substances.  

Key News 2024

• Brazil Proposes Stricter Lead Limits in Paints 
  The Brazilian Senate is reviewing Projeto de Lei Nº 3.428/2023, which aims to reduce the lead content in paints from 600 ppm to 90 ppm. Industrial and maritime paints will still be allowed to contain up to 600 ppm, but will have to carry warning labels in Portuguese. If enacted, manufacturers and importers will have one year to comply, and the existing Law 11.762/2008 will be repealed. Read more here. 

• Brazil Updates Cosmetics Regulations with RDC 907/2024 
  On September 23, 2024, ANVISA introduced RDC 907/2024, replacing several previous regulations to streamline compliance for cosmetics, personal hygiene, and perfume products. The update includes stricter labeling, mandatory registration, and enhanced microbiological controls. Companies must comply with these new requirements to avoid penalties. Read more here. 

• Brazil Implements Groundbreaking Chemical Management Law
  On November 13, 2024, Brazil took a major step forward in chemical safety with the sanctioning of Law 15.022/24, formerly known as PL6120/19, by President Lula. The law establishes the National Inventory of Chemical Substances, which provides a comprehensive framework for the evaluation, control and management of chemicals produced, imported, or used in Brazil. Companies operating in Brazil should prepare to comply with the new requirements as implementation progresses. Read more here.

On 26 December 2024, the Brazilian Health Regulatory Agency (ANVISA) issued a technical note detailing the toxicological classification process for formulated products derived from equivalent technica...

On 26 December 2024, the Brazilian Health Regulatory Agency (ANVISA) issued a technical note detailing the toxicological classification process for formulated products derived from equivalent technical products. The guidelines aim to ensure consistency in toxicological classification, particularly when complete product studies are unavailable, aligning with the standards of RDC No. 294, issued on July 29, 2019.

Overview of Toxicological Classification

ANVISA's classification framework evaluates formulated products based on available toxicological studies or, when unavailable, by analyzing the toxicological properties of individual components. This approach ensures comprehensive health and safety assessments, adhering to Good Laboratory Practices (GLP) and the standards set by the Brazilian Ministry of Agriculture.

Key Health Endpoints Assessed

The classification process relies on toxicological studies that address the following health endpoints:

• Acute oral toxicity (LD50)

• Acute dermal toxicity (LD50)

• Acute inhalation toxicity (LC50)

• Corrosion and irritation

• Sensitization

• Mutagenicity

When multiple toxicological endpoints are considered, the most restrictive classification is applied to ensure safety.

Classification in the Absence of Complete Studies

For products lacking toxicological studies, the classification relies on the properties of individual components. This process involves:

1. Researching Component Classifications: Using databases like the European Chemicals Agency (ECHA).

2. Verifying Cut-off Values: Ensuring compliance with Brazilian regulatory thresholds.

3. Calculating Component Concentrations: Determining the exact concentration of components in the product to guide classification.

The classification extends to critical hazards, such as:

• Respiratory sensitization

• Carcinogenicity

• Reproductive toxicity

• Specific target organ toxicity (single and repeated exposure)

• Aspiration hazards

Packaging and Labeling Requirements

To  promote transparency and compliance, the document specifies requirements for labeling and package inserts:

• Chemical names of hazardous components.

• Relevant toxicological information for user safety.

• Warning phrases compliant with ABNT NBR 14725, the Brazilian standard for labeling and hazard communication.

Additionally, hazard classification details must be included in the Optimized Reading Leaflet (FLORA), part of the Register of Agrochemicals.

Significance of the Updates Guidelines

This technical note underscores ANVISA's commitment to public health, environmental safety, and regulatory alignment. By establishing clear criteria for classifying toxicological risks, the Agency ensures:

• Enhanced Safety: Protecting workers, users, and the environment from hazardous exposures.

• Regulatory Clarity: Providing industries with structured methodologies for compliance.

• Global Alignment: Strengthening Brazil’s adherence to international safety standards.

ANVISA's updated guidelines for toxicological classification offer a robust framework for ensuring the safe use, labeling, and management of formulated products. For further details, refer to the complete guidelines available (in Portuguese)  here.