Brazil Issues New Law for Food Contact Regenerated Cellulose Films

Brazil publishes new legislation for regenerated cellulose films intended to come into contact with food.

On August 28, 2025, Brazil’s Ministry of Health/National Health Surveillance Agency (Ministério da Saúde/Agência Nacional de Vigilância Sanitária (ANVISA)) issued two documents to establish new sanitary requirements for food contact regenerated cellulose films.

These two inter-connected documents transposed Mercosur/GMC/Res. No. 16/25 ‘Mercosur Technical Regulation for Regenerated Cellulose Films Intended to Come into Contact with Food (Repeal of GMC Resolution No. 55/97)’ into the nation’s domestic law:

• Normative Instruction No. 396 of August 27, 2025 (Instrução Normativa (IN) No. 396, de 27 de Agosto de 2025, IN No. 396/2025) establishing two lists of authorized substances and their specifications for the manufacture of food contact regenerated cellulose films:

• Positive list for uncoated regenerated cellulose films (Annex I)

• Positive list for regenerated cellulose films coated with cellulose derivatives (Annex II)

• Resolution of the Collegiate Board of Directors RDC No. 992 of August 27, 2025 (Resolução da Diretoria Colegiada (RDC) No. 992, de 27 de Agosta de 2025, Resolution No. 992/2025) specifying the sanitary requirements for food contact regenerated cellulose films. These include, among other things, a specific migration limit of 0.01 mg/kg for the sum of primary aromatic amines (PAA) using simulant B (3% acetic acid) and conditions for using the authorized lists of substances under Annexes I and II in IN No. 396/2025

The provisions in both IN No.396/2025 and Resolution No. 992/2025 will become effective on February 28, 2026, six months after their publication in the Official Gazette of the Union (Diário Oficial da União, DOU).

Additionally, Resolution No. 992/2025 repeals Resolution RDC No. 217/2002 ‘Technical regulation on regenerated cellulose films in contact with food’.

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