,"Brazil’s National Health Surveillance Agency (ANVISA) has officially adopted RDC No. 992, issued 27 August 2025, establishing updated sanitary requirements for regenerated cellulose films intended to come into contact with food. The measure forms part of Brazil’s effort to harmonize with Mercosur regulations, replacing the older Regulation RDC 217/2002.
Alongside RDC 992/2025, Normative Instruction No. 396/2025 was published, defining positive lists of substances authorized for use in manufacturing these films and specifying conditions for both uncoated regenerated cellulose and those coated with cellulose derivatives.
Key requirements include limits on migration of certain compounds—e.g. a specific migration limit of 0.01 mg/kg for the sum of primary aromatic amines (PAA) when using simulant B (3% acetic acid).
The regulation applies to both films as finished products and films used as components in composite items.
These new standards will take effect on February 28, 2026, six months after publication in the Official Gazette of the Union (Diário Oficial da União)"