Brazil Regulatory News

On May 13, the Ministry of the Environment and Climate Change (MMA) launched a public consultation on the draft Decree intended to implement Law No. 15.022 of November 13, 2020 on the official page Pa...

On May 13, the Ministry of the Environment and Climate Change (MMA) launched a public consultation on the draft Decree intended to implement Law No. 15.022 of November 13, 2020 on the official page Participa + Brasil. The public consultation, which was open to interested parties on the government’s platform was cancelled a few days later.

The same proposal was then notified to the World Trade Organization (WTO) through a WTO notification. Only WTO Members countries can make comments on the draft, meaning that the general public would not be able to do it. The only plausible way to submit comments from companies and public entities is through national WTO TBT Enquiry Points.

The draft submitted to the WTO remains unchanged from the one published on the page Participa + Brasil. There is no official timeline for the final regulation to be published. Stakeholders are advised to monitor forthcoming developments closely, particularly any updates regarding the implementation timeline and reporting obligations.

From 4 July 2025, compliance with GHS Revision 7 will be mandatory in Brazil. This follows the publication of the updated ABNT NBR 14725 standard on 3 July 2023, which brings Brazil’s classification...

From 4 July 2025, compliance with GHS Revision 7 will be mandatory in Brazil. This follows the publication of the updated ABNT NBR 14725 standard on 3 July 2023, which brings Brazil’s classification, labelling, and safety data sheet (SDS) requirements into line with the seventh revised edition of the UN Globally Harmonized System (GHS 7). The two-year transition period is now coming to an end, meaning that all affected companies must fully implement the updated hazard communication rules.

The Brazilian Association of Technical Standards (ABNT) released the update on 3 July 2023, marking the most substantial update to the ABNT NBR14725 standard in over a decade. It introduces significant changes that brings Brazil's regulations closer in line with international standards, particularly the GHS. 

Key Changes and Enhancements

Structural Reorganization: One of the most notable changes is the restructuring of the standard's layout. Previously divided into four parts, the new version consolidates all the content into a single, more extensive and comprehensive section, making it easier for users to navigate and understand the requirements. 

Alignment with GHS 7: The updated ABNT NBR 14725 Standard is based on the seventh revision of the GHS Purple Book. By adopting this GHS version, Brazil's regulations now closely align with international standards, promoting consistency and harmonization in chemical classification and labelling practices. 

New Hazard Classes: Two new hazard classes have been introduced: 

• Desensitized Explosives which address substances that have been treated to reduce their explosive properties.

• Ozone Depleting Substances which focus on chemicals that pose a risk to the ozone layer. 

Modified Labelling Elements: The labelling requirements have been updated, with changes to hazard statements (H phrases) and precautionary statements (P phrases). New H and P phrases have been added to provide more specific information about potential hazards and necessary precautions. Existing phrases have also been modified to enhance clarity and accuracy. 

Communication of Hazards for Small Packaging: The updated standard introduces new rules for labelling small packaging. These regulations ensure that even the smallest containers carry essential information about the hazardous nature of their contents, thereby enhancing safety measures and risk awareness. 

Revised Safety Data Sheet (SDS): The standard introduces a change in terminology for Safety Data Sheets (SDS). Formerly known as Material Safety Data Sheets (MSDS), they will now be referred to as SDS, thus aligning the Brazilian naming convention with international standards. The content and structure of SDSs remain largely unchanged, maintaining the requirement of 16 sections, each providing crucial information about chemical properties, handling, and safety measures. 

Impact and Compliance

Mandatory Updates: All companies are required to update their existing Safety Data Sheets (SDSs) to comply with the new standard. The change in document nomenclature necessitates revisions to ensure consistency and alignment with the updated requirements. Additionally, labels may need to be revised to reflect the modified hazard statements and precautionary phrases. 

Time and Cost Implications: Achieving compliance with the updated regulations may require additional investment in resources and expertise. Companies may need to allocate time and funds for training employees, acquiring specialized technologies, and reviewing and updating their SDSs and labels. The scale of these tasks will depend on the company’s size and the number of products in its portfolio. 

Revised Classification: Due to changes in concentration limits, some products that were previously classified may no longer require classification under the updated standard. However, it is important to note that this change does not apply universally, except for the inclusion of the new hazard class "Desensitized Explosives." 

Companies handling chemicals in Brazil should now complete their compliance preparations. All required updates to SDSs and labels must be finalized before 4 July 2025, when the revised standard becomes legally mandatory.

Access to the NBR 14725 standard via the ABNT Catalog website, through the link: ABNT Catálogo (abntcatalogo.com.br)

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).