The Americas

Regulatory news in the Americas

Brazil – ANVISA updates the lists of components, usage limits, property declarations, and supplementary labeling of food supplements

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The National Health Surveillance Agency (ANVISA in Portuguese) has published Regulatory Instruction No. 373/2025, amending Regulatory Instruction No. 28 of July 26, 2018, which establishes the lists of ingredients, limits of use, property declarations, and supplementary labeling for food supplements.

Updated:

I – “List of ingredients authorized for use in food supplements, except those indicated for infants (0 to 12 months) or young children (1 to 3 years)”, included in Annex I;

II – “List of minimum limits of nutrients, bioactive substances, enzymes, and probiotics that food supplements must provide, according to the recommended daily intake and by population group indicated by the manufacturer”, included in Annex III;

III – “List of maximum limits for nutrients, bioactive substances, enzymes, and probiotics that food supplements may not exceed, according to the recommended daily intake and per population group indicated by the manufacturer,” contained in Annex IV;

IV – “List of claims authorized for use on the labeling of food supplements and their respective composition and labeling requirements,” contained in Annex V; and

V – “List of supplementary labeling requirements for food supplements,” contained in Annex VI.

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Brazil – ANVISA publishes the lists of components, usage limits, and property declarations for infant formulas, nutritional formulas, enteral nutrition formulas, and dietary therapy formulas for congenital metabolic disorders

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The National Health Surveillance Agency (ANVISA in Portuguese) has released Normative Instruction No. 367/2025, which outlines the lists of components, usage limits, and property declarations for infant formulas, nutritional formulas for high-risk newborns, transitional foods, and cereal-based foods for infants and young children, enteral nutrition formulas, and dietary therapy formulas for congenital metabolic disorders.

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Brazil – ANVISA has published regulations regarding sanitary requirements for infant formulas, nutritional formulas, and dietary therapy formulas for congenital metabolic disorders

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The National Health Surveillance Agency (ANVISA in Portuguese) has issued Resolution No 976/2025, which outlines the health requirements for infant formulas, nutritional formulas for high-risk newborns, transitional foods, and cereal-based foods for infants and young children, enteral nutrition formulas, and dietary therapy formulas for congenital metabolic disorders.
This Resolution is applicable to:

I – Infant formulas for infants;
II – Follow-on infant formulas for infants and young children;
III – Infant formulas for specific dietary therapy needs;
IV – Nutritional formulas for high-risk newborns;
V – Transitional foods for infants and young children;
VI – Cereal-based foods for infants and young children;
VII – Pediatric formulas for enteral nutrition;
VIII – Standard formulas for enteral nutrition;
IX – Modified formulas for enteral nutrition;
X – Nutritional modules for enteral nutrition; and
XI – Dietary formulas for congenital metabolic disorders.

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Argentina – The National Institute of Viticulture updates the requirements for imported wine products

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The National Institute of Viticulture has published Resolution No 20/2025, which establishes that imported wine products must comply with the analytical composition requirements and limits required for similar products of domestic production, as established in Law No 14,878 and complementary regulations. Resolutions Nos. C.121/93, C.36/2012, C.30/16, and Provision No. 1,193/93 are hereby repealed.

ARTICLE 1.- Imported wine products must comply with the analytical composition requirements and limits required for similar products of domestic production, as established in Law No. 14,878 and complementary regulations.

ARTICLE 2.- In the case of imports of products originating in countries with which agreements have been signed regarding oenological or similar practices, the requirements of Law No. 14,878 shall be deemed to have been met.

ARTICLE 3.- Imports of fractionated wine products will prove their authenticity and suitability for consumption when they present an analytical certification issued by the competent authority of the country of origin or an officially authorized entity, which includes the following determinations:

Alcohol, % v/v at 20°C

Reducing sugars and/or glucose + fructose g/l

Total acidity expressed as tartaric acid, g/l

Volatile acidity expressed as acetic acid, g/l

Methanol, mg/l or ml/l

Total sulfur dioxide, mg/l

ARTICLE 4.- The analytical certification cited above must be accompanied by an Import Affidavit, processed electronically, providing details of the transaction and the products to be imported.

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Argentina – Yatay palm fruit is included in the Argentine Food Code

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By means of Joint Resolution 30/2025, the Secretariat of Health Management and the Secretariat of Agriculture, Livestock and Fisheries amended the Argentine Food Code to include in Article 888 of Chapter XI – “VEGETABLE FOODS”, fruit of the yatay palm (Butia yatay).

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