Month: March 2025

Argentina/Paraguay – ANMAT and DINASVISA signed a sanitary agreement that will facilitate food trade between the two countries

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The head of the National Administration of Medicines, Food and Medical Technology (ANMAT in Spanish), Agustina Bisio, and her counterpart of the National Directorate of Health Surveillance (DINAVISA in Spanish), Jorge Iliou Silvero, signed in Asunción an agreement by which food, packaging and materials in contact with food can be imported by Argentina, and the same with those sent from Argentina to Paraguay by mutual recognition.

From now on, foods approved by DINAVISA will have, when imported, the same level of sanitary quality as those endorsed by ANMAT, and vice versa, a procedure that will facilitate trade between both nations.

The document represents a significant step towards strengthening food safety in the region, as Paraguay is the first country to sign this type of agreement after the modification of the Argentine Food Code (CAA in Spanish).

By recognizing their control systems, Argentina and Paraguay seek to eliminate technical barriers to trade, while maintaining high standards of protection for the health of their citizens, generating mutual benefits for both parties.
The director of DINAVISA, Jorge Iliou Silvero, mentioned that the document agreed on the simplification and mutual recognition of regulatory decisions, which will facilitate the requirements for food imports and exports between both countries.

Brazil – Anvisa publishes Regulatory Instruction that establishes an optimized procedure for the analysis of requests in the area of ​​food

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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.

INSTRUÇÃO NORMATIVA – IN Nº 344, DE 20 DE FEVEREIRO DE 2025 – INSTRUÇÃO NORMATIVA – IN Nº 344, DE 20 DE FEVEREIRO DE 2025 – DOU – Imprensa NacionalDownload

Argentina – INAL publishes guidelines on the procedures and implementation of the Decree on the import and export of food and materials, containers and utensils intended to be in contact with food

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The National Food Institute (INAL in Spanish) has published a series of questions and answers to clarify doubts related to Regulatory Decree No 35/2025, which establishes the procedures for the import and export of food and materials, containers and utensils intended to be in contact with food.

  • What is this decree about?
  • What is the scope of the standard?
  • What happens with products that are not defined in the Argentine Food Code?
  • What happens if a national manufacturer wants to produce a product similar to another one that has been imported without being included in the Argentine Food Code?
  • Economic Integration Treaties and Reciprocity Agreements: Which countries would be specifically addressed in this point and what happens when the agreements are limited to some food categories?
  • In relation to origin, is the country of manufacture of the product (origin) or the origin of the product considered?
  • Do imported Annex III products actually have to comply with all the requirements of the FAC (excluding articles 1416 bis, tris, quarter and fifth)?

Brazil – ANVISA publishes draft modification of the list of contaminants in foodstuffs

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The National Health Surveillance Agency (ANVISA in Portuguese) has published Public Consultation No. 1.311/2025, Subject: Proposal of Normative Instruction that modifies Normative Instruction – IN No. 160, of July 1, 2022, which establishes the maximum tolerated limits (MRL) of contaminants in food.

  • Peanuts, including those intended for later consumption. treatment.
  • Corn kernels (whole, split, crushed, ground) for further processing.
25_01752_00_xDownload

Uruguay – Modification of GMC Resolution No. 63/18 “MERCOSUR Technical Regulation for the Allocation of Additives and their Maximum Limits for the Food Category: Category 8: Meats and Meat Products

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The E-Government and Information and Knowledge Society Agency has published for public consultation “Modification of Resolution No. 63/18 ‘MERCOSUR Technical Regulations on the Allocation of Additives and their Maximum Limits for Meat and Meat Products’.
The document submitted for public consultation includes acetic acid, INS 260, with acidulant function, concentration limit 2g/100g and with the note “only for treatment of natural wrappings”, for food category 8: Meat and Meat Products, subcategories 8.2.1.2 Dried Sausage and 8.2.1.3 Cooked Sausage, regulated in Resolution GMC No. 63/18.

103416_P. RES_004-2024_ES_Modificacion Res 63-18-ac aceticoDownload