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Brazil updates food contact material regulations: adding two new substances and their restrictions

Time：

2025-03-10

Brazil updates its regulations on food contact materials, adding two new substances and their restrictions.

On February 6, 2025, the Brazilian National Health Surveillance Agency (ANVISA) recently issued Resolution 961 (RDC 961/2025), which significantly revised the list of permitted substances for food contact plastic packaging and equipment. This revision aims to respond to the latest scientific research and technical coordination requirements of the Southern Common Market (MERCOSUL), further safeguarding consumer health and food safety.

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According to the resolution, the "List of Permitted Monomers, Initiators, and Polymers" in RDC 56 regulation issued in 2012 will add the following two categories of substances:

1. Monomer and initiator: TMBPF-DGE

·Chemical name: Tetramethylphenol-F-diglycidyl ether (TMBPF-DGE) - the reaction product of tetramethylbis (4-hydroxyphenyl) methane and epichlorohydrin.

·Application scope: limited to water-based polymer dispersed coatings on the inner wall of beverage cans.

·Specific migration limit (T):

0.2 mg/kg (sum of TMBPF, TMBPF-DGE, TMBPF-DGE · H ₂ O, and TMBPF-DGE · 2H ₂ O);

0.05 mg/kg (the sum of TMBPF-DGE · HCl, TMBPF-DGE · 2HCl, and TMBPF-DGE · HCl · H ₂ O).

2. Polymer: PAI-2 (polyamide imide 2)

·Chemical name: Polymer formed by the reaction of 4,4 '- diaminodiphenylmethane with benzoyl chloride-3,4-dicarboxylic anhydride.

·Application restrictions:

Only used as an adhesive for high-temperature cookware coatings, with a coating thickness not exceeding 60 microns;

The upper limit of the applicable temperature is 230 ° C, and the short-term (≤ 15 minutes) tolerance temperature can reach 250 ° C.

This resolution shall come into effect from the date of its announcement, and relevant enterprises shall immediately verify the product formula and production process to ensure compliance with the restrictions on newly added substances. ANVISA will strengthen the inspection of imported and domestically produced food contact materials, and violators may face product delisting or administrative penalties.