Brazil Regulatory News

Brazil’s National Health Surveillance Agency (ANVISA) has announced a broad revision of its regulatory framework for dietary supplements, updating the official lists of authorised ingredients, usage...

Brazil’s National Health Surveillance Agency (ANVISA) has announced a broad revision of its regulatory framework for dietary supplements, updating the official lists of authorised ingredients, usage limits, health claims, and mandatory warning labels.

The changes were issued through Normative Instruction No. 373, published on 5 June 2025, and amend Normative Instruction No. 28 of 2018, which sets the standards for the formulation and labelling of dietary supplements sold in Brazil.

New Additions and Limits for Nutrients and Probiotics

The updated regulation includes the addition of several nutrients, bioactive substances, enzymes, and probiotics to the authorised list for supplements intended for individuals over 4 years old.

Among the notable inclusions are:

• Citrus fibres and 2'-fucosyllactose (a prebiotic carbohydrate produced via microbial fermentation).

• Chlorella pyrenoidosa powder as a source of vitamin A.

• The bioactive gamma-aminobutyric acid (GABA).

• Probiotic strains such as Lactobacillus acidophilus DDS-1®, Bacillus coagulans SNZ 1969, and a three-strain combination involving Lactobacillus plantarum and Pediococcus acidilactici.

Minimum and maximum recommended intake levels for these substances have been defined per population group, with specific thresholds set for adults, adolescents, and children over four.

Updated Health Claims and Safety Warnings

ANVISA has also authorised new health claims for certain probiotic strains, including gastrointestinal benefits and relief of intestinal discomfort in adults. However, these claims are restricted to products that meet precise composition and dosage requirements outlined in the regulation’s annexes.

At the same time, complementary labelling requirements have been expanded to include mandatory health warnings, especially for vulnerable populations such as pregnant women, children, and immunocompromised individuals. For example:

• Products containing GABA must carry the warning: “This product should not be consumed by pregnant women, breastfeeding women, or children.”

• Probiotic supplements must carry more extensive warnings, such as: “This product should not be consumed by infants, young children, pregnant or breastfeeding women, or immunocompromised individuals.”

Two-Year Transition Period for Compliance

Manufacturers have been granted a 24-month period to adapt their product labelling to comply with the new requirements. This applies to supplements that were already authorised under ANVISA's regulatory framework before the publication of the new instruction.

The changes were adopted by ANVISA’s Collegiate Board in a meeting held on 4 June 2025 and signed by the agency’s Acting Director-President, Rômison Rodrigues Mota. For further details, you can find the Normative here (in Portughese). 

Brazil’s National Health Surveillance Agency (ANVISA) has issued a sweeping update to its regulation on pesticide and disinfectant residues, modifying monographs for several active ingredients used ...

Brazil’s National Health Surveillance Agency (ANVISA) has issued a sweeping update to its regulation on pesticide and disinfectant residues, modifying monographs for several active ingredients used in agrochemicals, wood preservatives, and sanitation products. The changes were published through Normative Instruction No. 371 on 5 June 2025 and took immediate effect.

The resolution, adopted by ANVISA’s Collegiate Board, revises maximum residue limits (MRLs), pre-harvest intervals, authorised crop uses, and definitions of dietary risk assessments across a broad range of substances used in Brazilian agriculture and industrial hygiene.

Key Modifications Across Ingredients

According to ANVISA, the changes include:

• New residue definitions for ingredients such as atrazine, clomazone, flutriafol, and imazapyr, clarifying how dietary risk assessments and MRL compliance are to be interpreted.

• Expansion of approved crops for several substances. For example, acid indoleacetic now includes wheat, while carbaryl is authorised for use on coffee and sugarcane under defined conditions.

• Revised MRLs and safety intervals for crops such as coconut, cotton, rice, soy, maize, and several fruits and vegetables. For instance, the MRL for chlorantraniliprole on apples has been changed to 0.15 mg/kg.

• Addition of new crops and application types for various active ingredients, including post-emergence and pre-emergence uses. Some ingredients now include non-food uses such as turf or ornamental plants.

Substantial Revisions for Multiple Substances

One of the most extensive updates concerns ciclobutrifluram, whose monograph now contains an expanded residue definition including both the parent compound and specific metabolites. Additionally, crops such as tomato, soy, and citrus have seen MRL updates under various active substances such as metoxifenozide, mandipropamid, and pidiflumetofen.

Notably, sugarcane, tobacco, garlic, and chickpeas, among many others, have been added to the authorised crop lists for several active ingredients, reflecting changes in national agricultural patterns and the need for updated toxicological evaluations.

Regulatory Context and Legal Basis

The update was authorised under Law No. 9.782/1999 and ANVISA’s internal regulations (RDC No. 585/2021), with deliberations held by the agency’s Collegiate Board on 4 June 2025. The new norms amend the original framework set by Normative Instruction No. 103 of 19 October 2021, which established Brazil’s current list of approved active ingredients for pesticides, disinfectants, and wood preservatives.

Implementation and Monitoring

Effective immediately, the updated limits and authorisations are binding and published in Brazil’s Official Gazette (Diário Oficial da União), Section 1, on 9 June 2025. Stakeholders in the agricultural, food safety, and chemical manufacturing sectors are advised to review the full list of changes to ensure continued compliance with national residue regulations. For further details, you can find the Regulation here (in Portughese). 

A bill aiming to establish a national policy for the control of PFAS per- and polyfluoroalkyl substances, often referred to as "forever chemicals" (PFAS) is gaining momentum in the Brazilian Chamber ...

A bill aiming to establish a national policy for the control of PFAS per- and polyfluoroalkyl substances, often referred to as "forever chemicals" (PFAS) is gaining momentum in the Brazilian Chamber of Deputies.

Introduced by Deputy Juninho do Pneu (UNIÃO-RJ) on May 22, 2023, Bill PL 2726/2023 seeks to regulate the use, monitoring, and elimination of PFAS across Brazil. These synthetic chemicals, found in a wide range of consumer products from non-stick cookware to firefighting foams, are known for their persistence in the environment and links to serious health issues, including cancer and hormonal disruption.

The bill is currently ready to be placed on the agenda of the Committee on Environment and Sustainable Development (CMADS) after a series of deliberations. Most recently, on April 8, 2025, CMADS issued a favorable report recommending the approval of the bill with a substitute text proposed by Deputy Duda Salabert (PDT-MG). Two amendments to the substitute text were rejected during this process.

Despite progress, the bill faced a temporary setback when it was removed from the committee’s agenda on April 9, 2025, due to an agreement among members. Meanwhile, requests have been filed by other lawmakers to expand the bill's analysis to include the Committee on Economic Development and the Committee on Industry, Commerce and Services, suggesting broader implications for national economic and industrial policy.

The legislative journey of PL 2726/2023 reflects growing concern in Brazil about the environmental and public health risks posed by PFAS, and aligns with international trends seeking stricter controls over these hazardous substances.

If passed, the bill will mark a significant step in Brazilian environmental legislation and reinforce the country’s commitment to safeguarding public health and ecological integrity. For more information, you can find the proposal (in Portughese) here. 

On May 13, the Ministry of the Environment and Climate Change (MMA) officially launched a public consultation on the draft Decree intended to implement Law No. 15.022 of November 13, 2024. The law est...

On May 13, the Ministry of the Environment and Climate Change (MMA) officially launched a public consultation on the draft Decree intended to implement Law No. 15.022 of November 13, 2024. The law establishes the National Inventory of Chemical Substances and outlines procedures for the assessment and management of risks posed by chemicals produced, imported, or used within Brazil.

The consultation, led by the Secretariat for Urban Environment and Environmental Quality, will remain open until June 13, 2025. Interested parties must log in to the government’s platform to participate. 

Objective: Minimizing Risks to Health and the Environment

The proposed Decree provides a comprehensive regulatory framework aimed at systematically managing chemical substances and their potential risks. It establishes mechanisms to:

• Register chemical substances used, produced, or imported in Brazil;

• Prioritize substances for risk assessment;

• Assess risks to human health and the environment; and

• Implement risk management measures.

Key Provisions in the Draft Decree

• Thresholds for Registration: Chemicals that exceed 1 tonne/year of production or import (average over the past three years) must be registered.

• Committee Structure: The Technical Committee for Chemical Substances Assessment and a Deliberative Committee will oversee evaluation and decision-making processes.

• Use of Alternative Methods: The decree strictly regulates the use of animal testing, requiring it only as a last resort.

• Confidential Business Information (CBI): Provisions are included to protect trade secrets, with a clear process for requesting confidentiality.

• Fees and Enforcement: The decree introduces a Chemical Substance Registration, Evaluation, and Inspection Fee (TCAFSQ) and details the responsibilities of various regulatory bodies such as IBAMA, ANVISA, INMETRO, and the Ministry of Labor and Employment.

Call for Public Participation

Stakeholders from industry, academia, civil society, and government are encouraged to contribute comments and suggestions. The decree represents a critical milestone in the development of Brazil’s chemical regulatory infrastructure, offering a strategic tool to improve risk management, public health, and environmental safety. For more information and access to the draft decree, you can find it here (in Portughese).

  The Brazilian National Health Surveillance Agency (ANVISA) has launched a public consultation on the proposed regulatory framework for post-consumer recycled polyethylene terephthalate (PET-PCR)...

The Brazilian National Health Surveillance Agency (ANVISA) has launched a public consultation on the proposed regulatory framework for post-consumer recycled polyethylene terephthalate (PET-PCR) food-grade packaging materials. The consultation aims to revise the current sanitary requirements for these materials used in packaging that come into contact with food.

The proposed regulation is the result of ongoing negotiations within the Mercosur bloc and seeks to update the sanitary requirements for the recycling of post-consumer PET. This includes the incorporation of new parameters for chemical recycling processes. The new framework is designed to ensure that recycled PET meets stringent health standards while facilitating trade within Mercosur by harmonizing technical regulations.

Key Details of the Proposed Regulation:

• Consultation Period: March 28, 2025 – May 19, 2025

• Regulation Title: Requirements for Food-Grade Recycled PET Packaging (PET-PCR) for Food Contact

• Motivation: The proposal addresses advancements in chemical recycling technologies, ensuring the safety of recycled PET materials used in food contact packaging.
• Public Participation: Stakeholders are encouraged to participate in the consultation by submitting their contributions through the provided form. The feedback will play a crucial role in shaping the final regulatory text, aligning it with international standards, and ensuring the safety and efficacy of recycled PET in food packaging applications.

The MERCOSUR Regulatory Technical Regulation (RTM) on PET-PCR, which aims to replace the existing Resolution GMC 30/07, includes several important aspects regarding the safety and approval process for recycled PET used in food packaging.

• Regulation Scope: The updated regulation addresses recycled PET derived from post-consumer materials and industrial waste, focusing on ensuring the safety of recycled products intended for food contact.

• Approval and Compliance: The regulation requires the approval of both the recycling process and the establishments producing PET-PCR food-grade materials. It includes guidelines on contamination, process validation, and the quality assurance measures needed to ensure that recycled PET materials do not pose a health risk.

• Safety Standards: The proposed regulation sets clear limits for contaminants and requires the recycling process to meet stringent decontamination standards. This includes the validation of physical and chemical recycling technologies and the use of safety protocols that ensure the quality of the final products.

For more detailed information, the full documentation of the Regulatory Technical Regulation MERCOSUR on Recycled PET Packaging is available here (in Portughese). 

Accessing the Consultation: For more details and to submit contributions, access the consultation documents and submission forms can be found here (In Portughese). 

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.