Brazil Regulatory News

Brazil’s National Commission for Chemical Safety (Conasq), coordinated by the Ministry of the Environment and Climate Change (MMA), has issued an updated national register of chemicals present in pl...

Brazil’s National Commission for Chemical Safety (Conasq), coordinated by the Ministry of the Environment and Climate Change (MMA), has issued an updated national register of chemicals present in plastics that are regulated in the country. The revised list spans 579 entries and incorporates 15 newly added substances, consolidating requirements from Brazil’s health regulator Anvisa and standards body Inmetro into a single, public reference. 

What changed

• Scope expanded to 579 entries: The update adds 15 substances and harmonizes information previously spread across Anvisa resolutions and Inmetro ordinances, providing a clearer view of what’s permitted, restricted, or otherwise regulated when used in plastics in Brazil. 

• Structured, searchable identifiers: Each entry lists CAS number, IUPAC name, PubChem name, source list (Anvisa or Inmetro), and the exact normative act where the substance is regulated, reducing ambiguity for manufacturers, importers, and market surveillance. 

• Toys among priority product categories: The commission highlighted consumer items such as toys among the markets impacted by the refreshed list, underscoring risk management for children’s products. 

Link to the list and next steps for companies

• Where to consult: The MMA/Conasq announcement provides a public link to the updated list for immediate industry and public use. Companies should download the dataset, cross-check all intentionally added substances and possible impurities/additives against the CAS/IUPAC/PubChem fields, and document the applicable Anvisa/Inmetro citation for audit trails. 

• Internal actions to consider now

  1. Update substance inventories and bills of materials for plastic components;

  2. Re-run conformity checks for toys and other high-exposure items;

  3. Refresh supplier declarations to reflect the new entries and normative references;

  4. Align product labels and technical files with the controlling standard cited in the list;

  5. Monitor Conasq agendas and Anvisa/Inmetro normative updates for further changes. 

A groundbreaking law passed by the Brazilian government on July 30, 2025, now prohibits the use of animals in testing products such as cosmetics, personal care items, and perfumes, as well as their in...

A groundbreaking law passed by the Brazilian government on July 30, 2025, now prohibits the use of animals in testing products such as cosmetics, personal care items, and perfumes, as well as their ingredients. The new legislation, signed by President Luiz Inácio Lula da Silva, marks a significant step forward in the nation's animal welfare efforts.

The law amends two critical pieces of legislation—Law No. 11,794 (2008) and Law No. 6,360 (1976)—to explicitly ban the testing of products and ingredients on vertebrate animals, including those used for safety, efficacy, or danger assessments. The amendment also enforces stricter labeling regulations on products that may have been tested on animals before the law's enforcement.

Key Provisions

Under the revised Law No. 11,794, the following points stand out:

1. Prohibition on Animal Testing: Sections 11 and 12 of the amended law clearly state that testing on vertebrate animals is prohibited for both finished products and ingredients used in personal care, cosmetics, and perfumes. This includes any testing aimed at evaluating the safety, efficacy, or potential harm of the substances.

2. Restrictions on Animal-Test Data: Data from animal testing carried out after the law’s enforcement will no longer be admissible for the approval or commercialization of personal care products. This extends to any animal test data used to support the safety claims of the ingredients.

3. Labeling Prohibition: Manufacturers whose products' safety has been certified through post-enforcement animal testing will not be allowed to label or advertise their products as "cruelty-free" or "not tested on animals." This aims to uphold transparency and prevent misleading claims.

4. Alternative Testing Methods: The law prioritizes the use of internationally recognized and validated alternative testing methods. It mandates that the Brazilian authorities expedite the recognition and adoption of these methods, ensuring they become widespread throughout the nation.

5. Exemptions in Exceptional Circumstances: There is a provision for exemption in rare instances where a cosmetic ingredient poses a significant health risk, and no viable alternative testing method exists. These exceptions will be handled by the National Commission for the Control of Animal Experimentation.

Implementation and Enforcement

The law mandates that the health authorities have a maximum of two years to implement and regulate these new rules. Specifically, the authorities are required to:

• Promote Alternative Testing: Create a strategic plan for the adoption of alternative testing methods across Brazil.

• Monitor Compliance: Establish measures to ensure companies do not use post-enforcement animal testing data for regulatory purposes.

• Ensure Accurate Labeling: Enforce regulations around the labeling of cruelty-free claims and ensure they align with the new legislation.

The amendment also adds a specific clause to Law No. 6,360 (1976), making compliance with the animal testing ban a requirement for product registration under Brazil’s health authority.

A Step Toward Global Change

Brazil’s landmark move positions the country as a global leader in ethical treatment of animals, aligning with international trends where more nations are adopting similar bans on animal testing for cosmetics. While some have already implemented these restrictions, Brazil is one of the largest emerging markets to take such decisive action.

This shift is expected to inspire many companies to embrace innovative, cruelty-free methods in their production processes, which could lead to broader changes across the global beauty and cosmetics industry. It is also seen as a major victory for animal rights groups, who have long advocated for such bans in the fight for humane testing practices.

The law goes into effect immediately following its publication, marking a historic day for Brazil and animal welfare advocates alike. For further details you can check the Law (in Portughese) here.

Brazilian Regulatory Authority Seeks Public ContributionsThe Brazilian Health Regulatory Agency (ANVISA) has opened a consultation period for a proposal to update its regulations concerning food addit...

Brazilian Regulatory Authority Seeks Public Contributions

The Brazilian Health Regulatory Agency (ANVISA) has opened a consultation period for a proposal to update its regulations concerning food additives and technological aids. The new guidelines will alter the existing rules under Instrução Normativa - IN nº 211, dated March 1, 2023. The regulatory updates focus on food additives and technological aids' technological functions, maximum usage limits, and conditions of use in food products.

The proposal, published in the Official Federal Gazette (DOU) on July 8, 2025, invites public feedback between July 15 and August 28, 2025, with a potential deadline extension depending on the volume of contributions. The initiative aims to ensure that food safety regulations align 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 continuous need for adjustments to the lists of authorized additives and technological aids. These updates help ensure that technological innovations remain consistent with the foundational principles governing the safe use of these substances. Additionally, the changes are driven by 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 that aid in food production but are not consumed directly, and their use may result in trace residues in the final product.

The proposed updates include several changes, such as:

1. Revision of Existing Categories: Adjustments to food product categories under the existing regulations will be made. For example, the category for "Other Dairy Products" will be removed, and substances used in these products will be redistributed under the newly proposed categories, aligning with market trends.
2. New Categories and Functions: The consultation aims 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 will address gaps in the current regulation, as the existing list does not cater to this rapidly expanding category.
3.  International Convergence: The updates will 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 it is unlikely to cause significant disruption in industry operations, but still requires consultation to ensure that stakeholders' concerns are addressed.

The regulatory body has emphasized that updates are essential to maintaining safe food production practices and promoting innovation in the food sector. With new food trends like plant-based diets growing in popularity, regulatory flexibility is crucial to enabling food manufacturers to adapt to market demands while ensuring public safety.

The updates aim to provide clarity for food manufacturers on the 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, ensuring 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 marks the third regulatory update attempt by ANVISA, following previous initiatives in August 2023 and November 2024. For further details you can consult the regulation (in Portughese) 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)

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).