Brazil Regulatory News

The Brazilian Health Regulatory Agency (ANVISA) has opened a public consultation on proposed updates to the lists of food additives and technological aids. The measure aims to amend Instrução Norm...

The Brazilian Health Regulatory Agency (ANVISA) has opened a public consultation on proposed updates to the lists of food additives and technological aids. The measure aims to amend Instrução Normativa - IN nº 211, of March 1, 2023, which currently regulates the technological functions, maximum usage limits, and conditions of use for such substances in food products.

The proposal, published in the Diário Oficial da União (DOU) on July 8, 2025. The consultation period runs from July 15 to August 28, 2025, with the possibility of extension depending on the number of contributions received. The initiative seeks to ensure that Brazilian food safety regulations remain consistent with technological advancements and global standards, keeping the regulatory framework in line with evolving industry needs.

ANVISA's decision to propose updates stems from the ongoing need to adjust the lists of authorized additives and technological aids. These revisions help ensure that technological innovations remain consistent with the fundamental principles governing the safe use of these substances. Additionally, the proposed changes respond to issues raised by industry stakeholders, including food manufacturers, public agencies, and regulatory experts, highlighting the importance of aligning with international best practices.

Food additives are substances added intentionally to foods to modify their physical, chemical, biological, or sensory properties during production, processing, or packaging. Technological aids, on the other hand, are materials used to facilitate food production but are not intended for consumption, although their use may result in trace residues in the final product.

• Revision of Existing Categories: Adjustments will be made to existing food product categories under the current regulation. For example, the category "Other Dairy Products" will be removed, and the substances previously listed under it will be redistributed into newly proposed categories, better reflecting current market trends.
• New Categories and Functions: The consultation proposes to introduce specific provisions for the use of additives and technological aids in "plant-based" foods, a growing segment in the global food market. This update aims to address existing regulatory gaps as the current list does not adequately cover this rapidly expanding category.
•  International Convergence: The updates seeks to harmonize Brazilian regulations with international standards, particularly those established by the Codex Alimentarius, the global food safety standards body. This is part of an ongoing effort to ensure that Brazilian food safety regulations meet global expectations and are consistent with international trade agreements.

Key Dates and Consultation Process

• Public Consultation Period: July 15 to August 28, 2025.
• Status: The proposal is currently open for public comments, and stakeholders are encouraged to submit their contributions.
• Regulatory Impact: The proposal is classified as low-impact, meaning the proposed updates are not expected to cause significant disruption to industry operations but still require consultation to ensure that stakeholders' concerns are addressed.

The proposed updates aim to provide clarity for food manufacturers regarding which substances that can be used in food products, ensuring that they are safe, effective, and aligned with the best available science. The regulatory changes will also aid in reducing trade barriers, as the Brazilian framework will increasingly reflect international norms.

Contributions from stakeholders are crucial for shaping the final regulatory outcome, helping ensure that it meets the needs of the food industry while safeguarding public health. ANVISA has committed to transparency throughout the process, with all relevant documents available for public review during the consultation period.

This initiative marks the third attempt by ANVISA to update the lists of food additives and technological aids, following previous initiatives in August 2023 and November 2024. For further details, the full draft regulation (in Portuguese) is available here.

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, 2024 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, 2024 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)

The Brazilian Association of Technical Standards (ABNT) released on July 3 of 2023, a significant update to the ABNT NBR14725 Standard, which governs the classification and labeling of chemicals. Thi...

The Brazilian Association of Technical Standards (ABNT) released on July 3 of 2023, a significant update to the ABNT NBR14725 Standard, which governs the classification and labeling of chemicals. This update marks the most substantial revision of the standard in over a decade, bringing important changes that align Brazil's regulations with international standards, particularly the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). 

Key Changes and Enhancements: The updated ABNT NBR14725 Standard introduces several notable changes, aimed at improving chemical classification, labeling, and hazard communication. Let's explore some of the key updates: 

• Structural Reorganization: One of the prominent modifications is the reorganization of the standard's structure. 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: The updated ABNT NBR14725 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 labeling practices. 

• New Hazard Classes: Two new hazard classes have been included in the classification system. The first is "Desensitized Explosives," which addresses substances that have been treated to reduce their explosive properties. The second is "Ozone Depleting," which focuses on chemicals that pose a risk to the ozone layer. 

• Modified Labeling Elements: The labeling requirements have been revised, with changes in hazard statements (H phrases) and precautionary statements (P phrases). New H and P phrases have been added, providing more specific information about potential hazards and necessary precautions. Existing phrases have also undergone modifications to enhance clarity and accuracy. 

• Communication of Hazard: The updated standard introduces new rules for labeling small packaging. These regulations ensure that even the smallest containers carry essential information about the hazardous nature of the contained substances, enhancing safety measures and risk awareness. 

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

Impact and Compliance: The update to ABNT NBR14725 has significant implications for companies handling chemicals in Brazil. Here are some key considerations: 

• 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 and updated to reflect the modified hazard statements and precautionary phrases. 

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

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

The updated ABNT NBR14725 Standard brings significant changes to the classification and labeling of chemicals in Brazil. By aligning with the 7th GHS revision and incorporating new hazard classes, the standard enhances hazard communication and harmonizes Brazil's regulations with international practices. Companies should promptly assess the impact of these changes, ensuring timely compliance with the updated requirements by reviewing and updating their Safety Data Sheets and labels. Organizations handling chemicals in Brazil are granted a two-year transition period to comply with the new standard. Full compliance is mandatory by July 4, 2025.

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

Price to aquire the new regulation is R$ 244.10 reais (50 US$) and is available only in Portuguese.

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). 

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).