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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. 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.