The Americas

Regulatory news in the Americas

Brazil – ANVISA publishes amendment on the regulation establishing the lists of components, limits of use, declarations and supplementary labeling of food supplements

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The National Health Surveillance Agency (ANVISA in Portuguese) has published Normative Instruction IN No. 361/2025, which amends Normative Instruction IN No. 28/2018, which establishes the lists of components, limits of use, declarations and supplementary labeling of food supplements.

Amendments:

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

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

III – “List of maximum limits for nutrients, bioactive substances, enzymes, and probiotics that food supplements cannot exceed, in the recommended daily intake and by 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 requirements for the supplementary labeling of food supplements”, included in Annex VI.

Art. 2 The “List of components authorized for use in food supplements, except for food supplements intended for infants (0 to 12 months) or young children (1 to 3 years)” in Annex I of Regulatory Instruction – EN No. 28 of 2018, enters into force with the addition of the components listed in Annex I of this Regulatory Instruction.

Art. 3 The “List of minimum limits of nutrients, bioactive substances, enzymes, and probiotics that food supplements must provide in the recommended daily consumption and by population group indicated by the manufacturer” in Annex III of Regulatory Instruction – IN No. 28 of 2018, will enter into force with the addition of the limits listed in Annex II of this Regulatory Instruction.

Sole paragraph. Footnote iii is changed to “As cholecalciferol. 1 μg of cholecalciferol = 40 IU of vitamin D = 0.3333 μg of calcidiol.”

Art. 4 The “List of maximum limits of nutrients, bioactive substances, enzymes, and probiotics that cannot be exceeded by food supplements in the recommended daily intake and by population group indicated by the manufacturer” of Annex IV of Regulatory Instruction – IN No. 28, of 2018, will enter into force with the addition of the limits listed in Annex III of this Regulatory Instruction.

Sole paragraph. Footnote ii is changed to “As cholecalciferol. 1 μg of cholecalciferol = 40 IU of vitamin D = 0.3333 μg of calcidiol.”

Art. 5. The “List of Authorized Declarations for Use in the Labeling of Dietary Supplements and the Respective Composition and Labeling Requirements” in Annex V of Regulatory Instruction – IN No. 28 of 2018 will enter into force with the addition of the declarations listed in Annex IV of this Regulatory Instruction.

Art. 6. The “List of Supplementary Labeling Requirements for Food Supplements” in Annex VI of Regulatory Instruction – IN No. 28 of 2018 will enter into force with the incorporation of the supplementary labeling requirements listed in Annex V of this Regulatory Instruction.

Art. 7. A period of 24 (twenty-four) months is established for the adaptation of the labeling of food supplements that contain any of the constituents provided for in this Regulatory Instruction and that have been regularized before the National Health Surveillance System by the date of publication of this Regulatory Instruction.

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Dominican republic – Congressmen approve school food and nutrition project

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The Chamber of Deputies approved on first reading, the school food and nutrition bill, which aims to regulate the nutrition of children and adolescents attending both public and private schools.

This initiative, authored by the deputy of the Modern Revolutionary Party (PRM in Spanish), Soraya Suarez, seeks to promote the formation of healthy eating habits in order to take advantage of their teaching-learning process.

The law establishes that the Ministry of Education of the Dominican Republic (MINERD in Spanish) through the National Institute of Student Welfare (INABIE in Spanish) will be in charge of ensuring compliance with the law.

Brazil – Anvisa announces the start of the monitoring cycle of pesticide residues in foodstuffs

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The National Health Surveillance Agency (ANVISA in Portuguese) started this month a new cycle of sample collection for the Pesticide Residue Analysis Program in Food. The action is a partnership with states and municipalities and with the Central Public Health Laboratory of Minas Gerais.

In a note, the regulatory agency reported that the 2025 cycle foresees the collection of 3 thousand 505 samples from a total of 13 foods, including pineapple, peanuts, potatoes, broccoli, coffee (powder), beans, oranges, cassava (flour), passion fruit, strawberries, okra, cabbage, wheat (flour).

Peru – Draft Regulation of Law No. 29632, Law to eradicate the production and marketing of informal, adulterated, or unfit alcoholic beverages for human consumption

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The Ministry of Production and Commerce has published the draft regulations for Law No. 29632, the Law to Eradicate the Production and Marketing of Informal, Adulterated, or Unfit for Human Consumption Alcoholic Beverages. The purpose of the law is to establish the regulatory provisions of said law and to establish the specifications and procedures for implementing control, oversight, and sanctioning actions related to the production or entry into the country of ethyl alcohol to its final destination, as well as to prevent the manufacture, marketing, and consumption of informal, adulterated, or unfit for human consumption alcoholic beverages.

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Uruguay – Amendment to GMC Resolutions No 50/97, 53/98, 51/00, 08/06 and 09/07 on Food Additives” – Draft Resolution No 01/25

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The document Draft Resolution No. 01/25 “Amendment of GMC Resolutions Nos. 50/97, 53/98, 51/00, 08/06, and 09/07 on Food Additives” is available in the “Related Documents” section at the end of this page. Interested institutions and individuals can submit contributions or proposals through the public consultation option.

The contributions received will be submitted to the technical specialists who participated in the discussion and preparation of the document. If deemed relevant, these contributions will be taken into account to consolidate the country’s position within SGT No. 3, where they will be discussed with representatives of the other States Parties. In accordance with the procedures established in GMC Resolution No. 45/17, if a consensus is reached, the final draft will be submitted to the Common Market Group (GMC) for consideration and eventually approved by said decision-making body for subsequent incorporation into national law.
It is worth noting that on May 12, 2025, Draft Resolution No. 01/25 was notified to the World Trade Organization (WTO) Committee on Technical Barriers to Trade, pursuant to Notification G/TBT/N/URY/104.
Therefore, proposals from other WTO Members outside MERCOSUR are scheduled to be received until July 11, 2025, i.e., for 60 days from the date of notification.

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