Food supplements (suplementos dietarios) are regulated in art. 1381 of the Argentine Food Act (Código Alimentario Argentino).
Food supplements are intended for the healthy population. Their purpose is the incorporation of nutrients for insufficient diets or increased necessities.
They can be supplied in solid forms (tablets, capsules, granules, powders or other) or liquid (drops, solution, or other), or other forms for gastrointestinal absorption.
Food supplements may contain peptides, proteins, fats, marine lipids, amino acids, carbohydrates, vitamins, minerals, fibers and herbs and combinations thereof.
Food supplements are not meant for therapeutic indications or pathological states.
a) Registration Requirement for the Importer
· The importer has to register in the Federal Information System for the Management of Food Control (Sistema de Información Federal para la Gestión del Control de Alimentos (SIFeGA)).
· After the registration, a number for the National Register of Establishments (Registro Nacional de Establecimiento (RNE)) will be assigned to the Importer. The registration dossier must include details about the technical director. The technical director must also hold a university degree.
· The registration fee is $ 350.
b) Registration Requirement for Products
· Products to be placed on the market in Argentina must be authorized and included in the National Register of Foodstuffs (Registro Nacional de ProductoAlimenticio (RNPA)). Authorization is granted within 30 days and for a period of 5 years. The fee is 275 $ per product.
· Products authorized in another MERCOSUR country are exempt from the authorization obligation. Still, 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.
· For the purpose of the authorization, the certificate issued by the competent authorities in the country of origin must be less than 6 months old.
· The authorization dossier must contain the following: The label and the brochures of origin, the composition and nutritional profile, specifications and analysis results of parameters included in the CAA for the product or ingredients, as regards fats, the origin and percentage, the analysis of total and trans fats, the production method, the label to be used, data justifying nutrition claims or gluten free as well as organic, kosher and other certificates.
a) Vitamins and Minerals
For vitamins and minerals, there are specific IDRs for men, women, pregnant and breastfeeding women and 5 age groups of children.
The levels concerning no observed adverse effects in Argentina are high, 100 times as high as the EU level.Also the levels for minerals are very high.
b) Herbal substances
· Herbal substances are exhaustively regulated in Argentina. Disposition N° 1637/01 establishes a positive and negative list of plants.
· Food business operators can apply for the authorization of other plant substances with ANMAT by presenting international scientific evidence which shows the use of the material in food. The decision-making process takes 180 days.
· Herbal substances are only authorized when they are combined withpeptides, proteins, fats, marine lipids, amino acids, fats, carbohydrates, vitamins, minerals or fibers.
c) Marine oils
Marine oils should contain at least 6% EPA and 6% DHA, and 15% and 10% respectively if they are derived from concentrated triglycerides.
d) Energy drinks
· Energy drinks are regulated in art. 1388 CAA and Disposition 3634/2005.
· The maximum levels are:
400 mg/100ml for taurine
250 mg/100ml for glucuronolactone
20 mg/100ml for caffeine
20 mg/100 ml for inositol.
· These maximum levels are remarkably strict as a 250 ml (8 oz.) drink may contain only 50 mg of caffeine.
a) Compliance with general labelling rules
· The labelling of food supplements must comply with the general food labelling law.
· These rules are based on MERCOSUR regulations.Chapter V of the Argentine Food Act incorporates MERCOSUR Resolution 26/03 on the labelling of prepacked foods and Resolution 46/03 on the nutrition labelling of prepacked foods into national law.
· The consumer must be provided with the following information:
- Brand and / or trade name of the product
- Legal name: “suplementodietario”
- Complete ingredient list (including additives)
- Name and address of the producer or importer
- National Registry of Establishment Number (RNE) of the producer or importer
- Date of minimum durability
- Batch number.
- Amount to be consumed per day
- Mode or form of consumption (e. g. with breakfast, with plenty of water, etc.)
b) Special labelling requirements for food supplements
In addition to the general labelling requirements, special rules apply to food supplements, pursuant to art. 1381 CAA:
· Herbal substances must be indicated on the label per common and Latin name and the used plant part
· Nutrition information must be provided per serving or daily recommended intake + % IDR
· The label must include advice to consult your doctor before using the product, to not use the product in case of pregnancy, lactation or by children (unless the product is specifically intended for them) and to keep it out of the reach of children.
· “Free sale” is prohibited on the label.
The following ingredient specific warnings are mandatory:
· 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 diabetics / This product contains carbohydrates and should be used with caution by diabetics.
· Diabetics: This product contains chromium, consult your doctor.
· This product is suitable for people who engage in physical activity that requires a contribution of daily calories higher than the average population (2,000 cal./day). Consumption must be under strict medical supervision (high calorie products for sports people).
· Contains phenylalanine: contraindicated for phenylketonuria.
c) Energy drinks
For energy drinks, there are specific rules for labelling and advertising.
· The label must contain the following warnings:
- Elderly or people with an illness should consult their physician before consuming this product
- CONSUMPTION WITH ALCOHOL IS HARMFUL TO HEALTH
· The warnings must be in letters that contrast with the colors of the background and with the other warnings, in a font size greater than 5% of the height of the container
Also for the advertising of energy drinks, special rules apply.
· They must not be associated directly or indirectly with consumption of alcoholic beverages.
· Energy drinks may not be presented as good for health
· They must not be linked to ideas of better sexual life, sports activities, or social prestige, manliness or femininity.
As regards claims, Argentine food law distinguishes between nutrient content claims and statements on health properties.
a) Nutrient content claims
· Chapter V CAA regulates complementary nutritional information (Información Nutricional Complementaria (INC)).
· There are authorized claims for energy, sugar, fats, saturates, trans fats, omega 3, 6, 9, cholesterol, sodium, salt, protein, fiber, vitamins and minerals (tables in 5.1and 5.2):
- Low, very low, high, source, without (added) etc.
- Increased/reduced: compared to a similar product, the ingredient must be clearly identified, and the difference must be declared
- 25% for macronutrients
- 10% for micronutrients
- “High energy" for energy drinks >190 kj/100 ml or 45 kcal/100 ml
b) Statements on health properties
Statements on health properties are regulated in Disposition 7730/2011.A statement on health properties is any representation that states, suggests or implies that there is a relationship between a food, or a component thereof, and health. Statements on health properties include function claims and disease risk reduction claims. These statements are not permitted in the labelling.
For publicity purposes, claims must first be submitted to the Evaluation Commission for the Authorization of Statements on Health Properties (ComisiónEvaluadora para la Autorización de Declaraciones de PropiedadesSaludablesen Alimentos). Once authorized, claims are reserved for the exclusive use by the applicant. So far, two claims have been authorized: one claim concerning calcium and bone health and one on phytosterols and cholesterol reduction.