ANVISA optimizes procedures for the analysis of procedures in the food area

The National Health Surveillance Agency (ANVISA in Portuguese) published Normative Instruction IN No. 344/25, which establishes the conditions for the optimized procedure for the analysis of requests for evaluation in the food area through the admission of supporting documentation issued by an Equivalent Foreign Regulatory Authority (AREE in Portuguese).

The Regulatory Instruction comes into force on March 23, 2025. Simplified petitions submitted before March 23, 2025 that do not comply with the NI may be subject to technical requirements for the submission of additional supporting documentation in accordance with the new Normative Instruction.

This Standard Instruction applies to the following evaluations:

I - food additives, except flavourings of regional botanical species.

II - processing aids, except enzymes as processing aids.

III - enzymes used as processing aids.

IV - new substance for food contact materials.

V - new technology applied to food contact materials.

VI - safety and efficacy of functional or health properties of novel foods and novel ingredients, except probiotics and enzymes.

For further information (in Portuguese), click on the Link