On February 6, 2025, Brazil’s National Health Surveillance Agency (ANVISA) issued Resolution No. 961 (RDC 961/2025), introducing significant revisions to the list of authorized substances for plastic food-contact packaging and equipment. The update aligns with the latest scientific research and technical harmonization requirements of the Southern Common Market (MERCOSUR), aiming to enhance consumer health and food safety protections.
The resolution adds the following two substances to the "List of Permitted Monomers, Initiators, and Polymers" under the 2012 RDC 56 regulations:
1. Monomer and Initiator: TMBPF-DGE
- Chemical Name: Tetramethyl bisphenol F diglycidyl ether (TMBPF-DGE)—reaction product of tetramethyl bis(4-hydroxyphenyl)methane and epichlorohydrin.
- Application Scope: Restricted to water-based polymer dispersion coatings for the interior of beverage cans.
- Specific Migration Limits (SML):
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- 0.2 mg/kg (sum of TMBPF, TMBPF-DGE, TMBPF-DGE·H₂O, and TMBPF-DGE·2H₂O);
- 0.05 mg/kg (sum of TMBPF-DGE·HCl, TMBPF-DGE·2HCl, and TMBPF-DGE·HCl·H₂O).
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2. Polymer: PAI-2 (Polyamide-imide 2)
- Chemical Name: Polymer derived from the reaction of 4,4'-methylenedianiline and benzophenone-3,4-dicarboxylic anhydride.
- Usage Restrictions:
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- Permitted only as a binder for high-temperature cookware coatings, with a maximum coating thickness of 60 micrometers;
- Maximum continuous use temperature: 230°C, with short-term tolerance (≤15 minutes) up to 250°C.
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The resolution takes effect immediately upon publication. Relevant enterprises must promptly review product formulations and manufacturing processes to ensure compliance with the new restrictions. ANVISA will intensify inspections of imported and domestically produced food-contact materials, and non-compliant companies may face product recalls or administrative penalties.
