Brazil Regulatory News

Brazil’s national health regulator, ANVISA, has introduced new sanitary requirements for regenerated cellulose films used in food packaging, in a move aimed at strengthening consumer safety and alig...

Brazil’s national health regulator, ANVISA, has introduced new sanitary requirements for regenerated cellulose films used in food packaging, in a move aimed at strengthening consumer safety and aligning domestic standards with regional trade partners. The regulation, known as RDC No. 992/2025, was approved on 27 August 2025. It will come into force in February 2026, six months after publication.

Aligning with Mercosur

The measure incorporates provisions from the Mercosur Resolution GMC No. 16/2025, ensuring that Brazil’s rules are harmonised with those of its neighbours. Regenerated cellulose films, thin sheets made from purified cellulose sourced from wood or cotton, are widely used in the food industry, including as wrappers for confectionery, baked goods and processed meats.

Key Provisions

Under the new rules, manufacturers will need to:

• Produce films under Good Manufacturing Practices.

• Restrict production to three categories: uncoated films, films coated with cellulose derivatives, and films coated with plastics.

• Use only substances authorised in Anvisa’s Instrução Normativa No. 396/2025 or in previously established regulations.

• Ensure that films comply with strict migration limits, preventing harmful chemicals from leaching into food.

Films that are printed or coloured face additional controls. For example, primary aromatic amines, a class of chemicals linked to health risks, must not migrate into food above trace levels of 0.01 mg per kilogram.

Industry and Consumer Impact

The move updates and replaces a previous 2002 regulation and is expected to modernise oversight of packaging materials that come into direct contact with food. Anvisa says the changes will increase transparency, requiring manufacturers and importers to make the chemical composition of their products available to authorities when requested. Industry experts say the resolution will also facilitate trade, given its alignment with European Union and US Food and Drug Administration (FDA) reference lists, which are commonly used benchmarks for food-contact materials.

Enforcement

Failure to comply will be treated as a sanitary infraction under Brazilian law, carrying administrative, civil and criminal liabilities.The food packaging sector has until February 2026 to adapt to the new standards. For further details on the Resolution you can find it here (in Portughese).

Brazil’s National Council for the Environment (Conama) has launched a public consultation on draft rules that would restrict the use of hazardous substances in electrical and electronic equipment. T...

Brazil’s National Council for the Environment (Conama) has launched a public consultation on draft rules that would restrict the use of hazardous substances in electrical and electronic equipment. The move marks an effort to align domestic regulation with international standards and strengthen environmental and health protections.

Consultation process

The notice, published in the Diário Oficial da União, formally opened Public Consultation No. 9. Citizens, companies and organisations are invited to submit contributions through the federal Participa + Brasil platform. The consultation runs for 45 days, from 11 August to 24 September 2025. 

Proposed restrictions

The draft resolution would prohibit the manufacture, import, distribution and sale of electrical and electronic equipment (EEE) containing certain hazardous substances above defined thresholds in homogeneous materials:

• Polybrominated biphenyls (PBB): 0.1%

• Polybrominated diphenyl ethers (PBDE): 0.1%

• Mercury (Hg): 0.1%

• Cadmium (Cd): 0.01%

• Hexavalent chromium (Cr VI): 0.1%

• Lead (Pb): 0.1%

• Phthalates (DEHP, BBP, DBP, DIBP): 0.1% each

Transition periods

The proposal sets strict deadlines:

• Immediate compliance for PBB and PBDE

• 180 days for mercury

• Three years for cadmium, hexavalent chromium and lead

• Four years for the four phthalates

Products already on the market before these deadlines would be exempt.

Exemptions and alignment with global rules

Temporary exemptions could be granted in cases where substitution is technically or scientifically impossible, unreliable, or would cause greater harm across a product’s life cycle. The ministry must publish an initial exemption list and define procedures for exemption requests within 180 days of the rule taking effect.

Renewal of exemptions would require advance requests, and officials are instructed to consider practices in jurisdictions with similar or stricter controls to ensure international harmonisation.

New registry and compliance duties

A National Register of EEE with Restricted Substances would be created, requiring manufacturers and importers to file a self-declaration of conformity before products are placed on the market. Declarations must accompany the product, on packaging or digitally, and companies would bear administrative and criminal responsibility for accuracy. Manufacturers, importers, distributors and retailers would have defined obligations, including providing documents in Portuguese, retaining records for five years, recalling non-compliant products, and ensuring traceability.

Labelling and enforcement

Products would need clear labelling in Portuguese for identification and traceability. Where relevant, they must also carry a symbol for selective disposal, supporting Brazil’s waste management and reverse logistics commitments. The environmental authority would be empowered to test products, require accredited laboratory reports, and impose penalties. Costs of testing, seizure and disposal would fall on the responsible companies.

List of substances

The restricted list may be updated every five years based on new scientific evidence, available alternatives and the precautionary principle.

Next steps

Once the consultation closes in September, Conama will analyse submissions before approving a final resolution. If adopted, the regulation would come into force immediately upon publication in the Diário Oficial da União.

Brazil’s National Health Surveillance Agency (Anvisa) has begun preparing its new Regulatory Agenda for 2026–2027, a process that will run until December this year in line with the country’s leg...

Brazil’s National Health Surveillance Agency (Anvisa) has begun preparing its new Regulatory Agenda for 2026–2027, a process that will run until December this year in line with the country’s legal and management framework. The agenda, which sets out the agency’s regulatory priorities for the next two years, must be published by 17 December. It is part of Anvisa’s Annual Management Plan and is required under Law No. 13.848/2019.

Public Participation Opens

Anvisa is currently in the stage of public engagement. Between 15 August and 15 September, citizens, civil society groups, and members of the National Health Surveillance System (SNVS) are invited to provide feedback on the preliminary list of regulatory themes. Contributions can be made through an online form.

Alongside commenting on the proposed topics, participants will also be able to suggest new items if they believe important regulatory issues are missing.

Preliminary List of Themes

The draft agenda features 115 regulatory themes, of which 97 were carried over from the 2024–2025 agenda and 18 are new proposals from Anvisa’s technical departments.

The agency has published the preliminary list in two formats – a summary in PDF and a detailed spreadsheet – to facilitate public review, and can be found here (in Portughese). 

Next Steps

Anvisa stresses that this consultation is a fact-finding stage and not the final list of priorities. The inputs collected will inform the final version of the Regulatory Agenda 2026–2027, which will be formally approved by Anvisa’s Collegiate Board later this year. A manual on how to participate to the consultation can be found here (in Portughese). 

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.