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 NI 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 NI.

This Normative Instruction applies to the following assessments:

I – Food additives, except flavourings of regional botanical species;

II – Processing aids, except enzymes as processing aids;

III – Enzymes used as processing aids;

IV – A new substance for materials in contact with food;

V – New technology applied to materials in contact with food;

VI – Safety and efficacy of the functional or health properties of new foods and new ingredients, except probiotics and enzymes;

VII – Safety and efficacy of the functional or health properties of enzymes as ingredients;

VIII – safety and efficacy of the functional or health properties of probiotics; and

IX – risk of products for veterinary use.