Argentina

I. DIETARY SUPPLEMENTS

(i) Dietary supplements (suplementos dietarios) are classified as foods and regulated in “Article 1381 of the Argentine Food Code (Código Alimentario Argentino - CAA)”.

(ii) Dietary supplements are intended for the healthy population. Their purpose is the incorporation of nutrients for insufficient diets or increased needs. They are not meant for therapeutic indications or disease states.

(iii) They may contain peptides, proteins, fats, marine oils, amino acids, carbohydrates, vitamins, minerals, dietary fibres and herbs and combinations thereof.

(iv) Dietary supplements can be supplied in solid forms (tablets, capsules, granules, powders or others) or liquid (drops, solution, or others), or other forms for gastrointestinal absorption.

The marketing requires both establishment and product registration.

II. PRODUCT REGISTRATION REQUIREMENTS

Products to be placed in Argentina must be authorised and included in the “National Register of Foodstuffs (Registro Nacional de Productos Alimenticios - RNPA)”.

• In accordance with the “Guidelines on sanitary authorisation of a food product (Directrices para la autorización sanitaria de producto alimenticio)”, the authorisation dossier must contain the following:
  • Certificate of free sales from the competent authorities of the country of origin which is maximum 6 months old;
  • The label and leaflet or other accompanying material from the country of origin;
  • Ingredient information and nutritional composition;
  • Authorisations for raw material and food-contact packaging material;
  • Product and ingredient specifications;
  • Storage conditions and shelf-life;
  • Manufacturing process;
  • The label to be used in Argentina compliant to Argentine law;
  • Data justifying nutrition claims or “free-from” claims;
  • Certificates in case of voluntary indications such as “Organic” or “Kosher” are included;
  • Payment of the applicable fees.
• In accordance with the updated tax list issued in March 2020 by the ANMAT, the fee for registration of dietary supplements is 11,120 ARS, equivalent to around 165 USD.
  • Sanitary authorisation (autorización sanitaria) is granted within 30 days and is valid for a period of 5 years.
  • Products authorised in another MERCOSUR country are exempted from the authorisation obligation. The food business operator must provide a certified declaration from the other MERCOSUR country and the original label and the product must be compliant with Argentine food law.

III. VITAMINS AND MINERALS

(i) The use of vitamins and minerals is regulated under “Article 1387 of CAA”.

(ii) Minimum levels should be at least 20% of the established Recommended Daily Intakes (RDIs).

(iii) Maximum levels are set at “No Observed Adverse Effects Levels” (NOAEL), which can be 100 times higher than those set at the EU.

(iv) Specific RDI and NOAEL levels are stablished for men, women, pregnant and breastfeeding women and 5 different age groups of children.

IV. HERBAL SUBSTANCES

(i) Herbal substances are exhaustively regulated in Argentina. “Disposition (Disposición) No. 1637/2001” establishes a positive and negative list of plants (Annex I and II).

(ii) Herbal substances are only authorised when they are combined with peptides, proteins, fats, fish oils, amino acids, fats, carbohydrates, vitamins, minerals or dietary fibres.

(iii) Food business operators can apply for the authorisation of other plant substances with the “National Administration of Medicines, Food and Medical Technology (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica - ANMAT)” by presenting international scientific evidence which shows the use of the substance in food. The decision-making process takes 180 days.

V. OTHER SUBSTANCES

(i) Considering the definition of dietary supplements, only peptides, proteins, fats, marine oils, amino acids, carbohydrates, vitamins, minerals, fibres and herbs and combinations thereof may be used in food supplements.

(ii) Moreover, it is required these substances are naturally present in foods.

(iii) Marine oils will consist of an isolated oil or mixture of fish oil or other marine organisms. They should contain at least 6% EPA and 6% DHA, and 15% and 10% respectively if they are derived from concentrated triglycerides.

VI. COMPLIANCE WITH GENERAL LABELLING RULES

(i) The labelling of dietary supplements must comply with the general food labelling law.

“Chapter V of CAA” incorporates into national law the following MERCOSUR regulations:

• “MERCOSUR Resolution No. 26/03” on the labelling of prepacked foods; and
• “MERCOSUR Resolution No. 46/03” on the nutrition labelling of prepacked foods.

The following information must be provided:

•  
• Brand and/or trade name of the product;
• Legal name: “suplemento dietario”;
• Net weight;
• Complete ingredient list (including additives);
• Allergens;
• Name and address of the manufacturer or importer;
• National Registry of Establishment number (RNE) of the manufacturer or importer;
• Country of origin;
• Preparation and instructions for use;
• Daily dose;
• Use by/ Best before date;
• Batch number and lot identification;
• Mandatory warning statements.

(ii) Special labelling requirements for dietary supplements

In addition to the general labelling requirements, special rules apply to dietary supplements, pursuant to “Article 1381 of CAA”:

• Herbal substances must be indicated on the label per common and Latin name and with the plant part source;
• Nutrition information must be provided per serving together with the percentage of the RDI;
• “Free sale” is prohibited on the label.

The following ingredient specific warnings are mandatory:

• Consult your doctor before consuming the product,
• Do not use in case of pregnancy, breastfeeding or by children (unless the product is specifically intended for them);
• Keep it out of reach of children;
• Exceeds daily reference intake of [vitamin/mineral];
• This product may cause toxic effects due to accumulation of fat-soluble vitamins [(A, D, E, or K)]. Do not consume without consulting your doctor;
• This product contains iron and should be consumed only by healthy individuals, consult your doctor before using;
• This product should not be used by people with diabetes / This product contains carbohydrates and should be used with caution by diabetics;
• People with diabetes: This product contains chromium, consult your doctor;
• This product is indicated for people who carry out a physical activity that requires a daily calorie intake higher than the population average (2,000 Kcal/day). Its consumption must be carried out under strict medical supervision.
• Contains phenylalanine: contraindicated for phenylketonuria.
• Contains propolis. Not to be consumed by allergic or sensitive people, children under 4 years, pregnant or lactating women.

Nutrient content claims are extensively regulated under “Chapter V of CAA”, which entails “MERCOSUR Technical Resolution No. 01/12” on complementary nutritional information.

Health claims, linking a food to specific health properties, cannot be included on the labelling. However, health claims can be authorised for advertising purposes in accordance with “Disposition (Disposición) No. 7730/2011”. The authorisation of claims is exclusive to the applicant.