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Registration of Dietary Supplement in Argentina

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Registration of Dietary Supplement in Argentina

Regulatory Authority

The National Administration of Drugs, Food and Medical Technology, ANMAT

Registration Timeline

Sanitary authorization with 30 days

License Validity

5 Years

Fees

11,120 ARS, / 165 USD.

Dietary Supplement

  • Dietary supplements, or suplimentosdietarios, are governed by “Article 1381 of the Argentine Food Code (Código Alimentario Argentino – CAA)” and are categorized as foods.
  • Dietary supplements are intended for a healthy population. Their goal is to include nutrients to meet increasing needs or insufficient diets. They are not intended for use in disease states or for therapeutic reasons.
  • Peptides, proteins, lipids, carbohydrates, amino acids, minerals, vitamins, dietary fibers, and herbs, and mixtures of these, may be present.
  • Dietary supplements can be supplied in solid forms such as tablets, capsules, granules, powders or other liquids such as drops, solution, or others, or other forms for gastrointestinal absorption.

Dietary Supplement Registration Requirements

  • Products must be approved and registered in the “National Register of Foodstuffs (Registro Nacional de Productos Alimenticios – RNPA)” to be marketed in Argentina.
  • The following is required to be included in the authorization dossier in compliance with the “Guidelines on sanitary authorisation of a food product (Directrices para la autorización sanitaria de productoalimenticio)”:
    1.  Free sales Certificate from the competent authorities of the country of origin which is maximum 6 months old.
    2. The leaflet and label or other accompanying material from the country of origin.
    3. Nutritional composition and Ingredient information.
    4. Authorizations for raw material and food-contact packaging material;
    5. Product and ingredient specifications;
    6. Storage conditions and shelf-life;
    7. Manufacturing process;
    8. The label to be used in Argentina compliant to Argentine law;
    9. Data justifying nutrition claims or “free-from” claims;
    10. Certificates in case of voluntary indications such as “Organic” or “Kosher” are included;
    11. Payment of the applicable fees.

Registration of Dietary Supplement in Argentina

  1.  Brand and/or trade name of the product;
  2. Legal name: “suplementodietario”;
  3. Net weight;
  4. Complete ingredient list (including additives);
  5. Allergens;
  6. Name and address of the manufacturer or importer;
  7. National Registry of Establishment number (RNE) of the manufacturer or importer;
  8. Country of origin;
  9. Preparation and instructions for use;
  10. Daily dose;
  11. Use by/ Best before date;
  12. Batch number and lot identification;
  13. Mandatory warning statements.

Special Labelling Requirements for Food Supplements

Apart from the standard labeling guidelines, nutritional supplements are subject to specific regulations as per “Article 1381 of CAA”:

  1.  Herbal ingredients must be included on the label together with the source plant part and both common and Latin names.
  2. Nutritional data per serving and the percentage of the RDI must be given.
  3. The label states that “free sale” is prohibited.

The following Ingredient Specific warnings are Mandatory

  1. Consult your doctor before consuming.
  2. Keep it out of reach of children;
  3. Exceeds daily reference intake of [vitamin/mineral];
  4. Do not use it in case of pregnancy, breastfeeding or by children unless the product is specifically intended for them.
  5. Because of the buildup of fat-soluble vitamins [(A, D, E, or K)], this product may have harmful consequences. Don’t take without first talking to your physician.
  6. This product includes iron; only well-informed people should use it; please see your physician before use.
  7. Diabetes sufferers should take this product with caution since it includes carbs and should not be used by them.
  8. People with diabetes: This product contains chromium, consult your doctor.
  9. This product is recommended for individuals who engage in physical activities that need them to consume more calories per day than the typical person (2,000 Kcal/day). It needs to be consumed under close medical care.
  10. Contains phenylalanine: contraindicated for phenylketonuria.
  11. Includes propolis. Not to be ingested by children under 4 years old, women who are pregnant or nursing, or those who are allergic or sensitive.

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