ANVISA Updates Regulations on Plastic Packaging and Equipment in Contact with Food

The National Health Surveillance Agency (ANVISA) has published on the 6th of February 2025, Resolution RDC No. 961/2025, amending Resolution RDC No. 56/2012 regarding the list of authorized monomers, initiator substances, and polymers for use in plastic packaging and equipment intended for food contact. The list of monomers and other authorized substances contained in Part I and the list of authorized polymers contained in Part V of the Annex of the Resolution 56/2012 shall come into force with the addition of the substances contained in Annex I and Annex II of this Resolution. 

The new resolution, approved by ANVISA’s Collegiate Board of Directors, incorporates provisions from GMC/MERCOSUR Resolution No. 28/2024 into Brazil’s legal framework.

Key Changes in RDC No. 961/2025

Annex I: Expansion of Authorized Monomers and Initiator Substances:

The resolution adds Tetramethyl Bisphenol F Diglycidyl Ether (TMBPF-DGE) (CAS No. 113693-69-9) to the list of authorized monomers and initiator substances.

• Specific migration limits (LME) have been established for TMBPF-DGE and its derivatives
• Its use is restricted to macromolecular substance dispersions in water for beverage can coatings.

Annex II: Inclusion of a New Authorized Polymer:

• Polyamide-imide 2 (PAI-2) (poly-N-(4,4'-diphenylmethane trimellitamide imide)) has been added to the list of authorized polymers.
• This polymer, produced from 4,4'-diaminodiphenylmethane and benzoyl-3,4-dicarboxylic anhydride chloride, is permitted for use as a binder in coatings for high-temperature-resistant kitchen utensils.
• Restrictions include:
  • Maximum coating thickness of 60 µm.
  • Safe usage at temperatures up to 230°C, or up to 250°C for short durations (15 minutes max).

Regulatory Impact and Industry Implications

The amendments provide manufacturers with additional material options while maintaining stringent safety and compliance standards for food contact applications.

Effective Date

RDC No. 961/2025 comes into effect immediately upon publication in the Diário Oficial da União on February 6, 2025. For more details, you can consult the full resolution here (in Portughese).