ANVISA establishes optimized analysis procedure for the food industry

On February 21, 2025, the Brazilian Health Regulatory Agency (“ANVISA”) published Normative Instruction (“IN”) No. 344/25, which establishes the optimized analysis procedure for the food industry by using assessments issued by a foreign regulatory authority (“AREE”).

IN No. 344/25 enters into force on March 23, 2025. Simplified petitions filed before March 23, 2025, that do not comply with this IN can be subject to technical requirements for submitting further mandatory documents, as established by IN No. 344/25.

What is an optimized analysis procedure?

The optimized analysis procedure – established by Resolution of the Collegiate Board (“RDC”) No. 741/22, which provides for the general criteria to approve the analysis carried out by the AREEs in collaboration with ANVISA – is a mechanism of technical analysis that is supported by regulatory reliance, in which ANVISA uses the technical assessment issued by a foreign regulatory authority as the sole or additional reference during the regularization process in Brazil.

An AREE is a regulatory authority or international entity with similar roles to those of ANVISA. It ensures that marketed products are assessed and duly comply with the recognized standards of quality, safety, and effectiveness. ANVISA recognizes AREEs as reliable authorities; therefore, their issued assessments may be considered by ANVISA.

Since 2022, the reliance strategy established by RDC No. 741/22 has been developed by ANVISA to improve its regulatory performance, such as IN No. 289/24 – which provides for the criteria applied to the optimized analysis procedure for the marketing authorization and post-market changes of medicines, biological products, vaccines, and Letter of Suitability of the Active Pharmaceutical Ingredient Dossier (“CADIFA”) in Brazil –, and IN No. 290/24 – which provides for the optimized analysis procedure and the decisions involving registration petitions of medical devices. 

This optimized procedure is essential to accelerate the regularization process of new products in Brazil, enabling that innovations arrive at the national market as soon as possible. By using the assessments of an AREE, ANVISA improves its responsiveness to the demands of the regulated sector, thus saving resources and time.

This IN provides for, among other provisions:

1. That it is applicable for the assessments of:
2. 1. food additives, except for flavorings from regional botanical species;
   2. processing aids, except for enzymes as processing aids;
   3. enzymes used as processing aids;
   4. new substances used to produce materials in contact with foods;
   5. new technologies applied to materials in contact with foods;
   6. safety and efficacy of functional or health properties of new foods and ingredients, except for probiotics and enzymes;
   7. safety and efficacy of functional or health properties for enzymes as ingredients;
   8. safety and efficacy of functional or health properties of probiotics; and
   9. risk of veterinary-related products.

2. The criteria qualifying an international authority as an AREE before ANVISA;

3. The list of AREEs recognized by ANVISA. This list can be updated upon request by interested parties through a specific petition containing the documentation that demonstrates the criteria for approval, which ANVISA will assess before its approval; and

4. The list of mandatory general, specific, and instructional documents for filing the submissions for the optimized analysis procedure, in compliance with Exhibits II, III, and IV of IN No. 344/25.

ANVISA’s decision will not be conditioned to the AREE’s decision, and can be specific to the requesting manufacturer if the AREE’s assessment is based on evidence limited to the specifications developed by the manufacturer. ANVISA’s criteria to support its decision are listed as follows:

• Transparent description of technical and scientific elements;
• Updated, consistent, and robust evidence;
• Adequate addressing uncertainties and information gaps;
• Lack of concerns arising from the use or consumption of food additives, processing aids, new substances or technologies to materials in contact with foods, new foods, new ingredients, enzymes, IFAs, or micro-organisms;
• Alignment between the assessment carried out and the decision; and
• Reasonableness of data extrapolation to the Brazilian context.

Demarest’s Life Sciences team is available to provide any further clarifications that may be necessary.