Brazil Regulatory News

President Luiz Inácio Lula da Silva has signed Decree No. 12,644, establishing the National Strategy for a Plastic-Free Ocean (ENOP) on the 7th of October 2025. The plan sets out goals through 2030 t...

President Luiz Inácio Lula da Silva has signed Decree No. 12,644, establishing the National Strategy for a Plastic-Free Ocean (ENOP) on the 7th of October 2025. The plan sets out goals through 2030 to prevent, reduce, and eliminate plastic waste in the oceans, through coordinated efforts among government agencies, businesses, and civil society.

Led by the Ministry of the Environment and Climate Change, the ENOP involves several ministries, including the Ministry of Fisheries and Aquaculture, which will focus on sustainable fishing practices and protection of coastal communities. Planned actions include waste removal, public awareness campaigns, stronger regulations, and investment in innovative technologies to replace single-use plastics.

Brazil is currently the 8th largest source of marine plastic pollution, dumping more than 190,000 tonnes of plastic into the sea every year, while only 10% of global plastic waste is recycled.

Structured around eight key pillars, from environmental education to circular economy, the ENOP aims to align Brazil with international sustainability targets and place the ocean at the center of its environmental agenda.

Brazil’s health regulatory agency, Anvisa, has launched a public consultation to gather feedback on new rules that would govern the production of handmade cosmetics, personal care products, and perf...

Brazil’s health regulatory agency, Anvisa, has launched a public consultation to gather feedback on new rules that would govern the production of handmade cosmetics, personal care products, and perfumes. The consultation opens on 13 October and will remain available for public contributions for 45 days, until the 26th of November 2025

The initiative follows the enactment of Law No. 15.154, approved on 30 June 2025, which amended the country’s long-standing Law No. 6.360/1976. The new law allows artisanal cosmetic producers to operate under simplified regulations and exempts their products from formal registration, a move aimed at distinguishing small-scale, handcrafted producers from large industrial manufacturers.

Under the proposed Resolution of the Collegiate Board (RDC) and Normative Instruction (IN), artisanal cosmetics would be defined as products made in small batches without automated machinery or specialized industrial processes. These items must also be sold directly to consumers, excluding commercial intermediaries.

Anvisa said the measure seeks to provide legal clarity while reducing risks associated with unregulated artisanal production, a sector that has expanded rapidly across Brazil. The agency emphasized that the consultation is an opportunity for citizens, entrepreneurs, and experts to help shape fair and practical regulations for this growing market.

The consultation, officially listed as Public Consultation No. 1,353 of 1 October 2025, will remain open until 26 November 2025. Contributions can be submitted through Anvisa’s online portal. Access to the consultation can be found here (in Portughese). 

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.