Uruguay

I. SUPPLEMENTS FOR SPORTS PEOPLE

Although there is no legal act for dietary supplements, the Uruguayan food code – Reglamento Bromatológico Nacional, Decreto 315/994 Anotado Febrero 2020 – includes a category for “foods for special purposes” (alimentos para usos dietéticos especiales). As a general requirement, to be qualified as a “food for special purposes” the composition needs to differ from conventional foods and are defined as: “foods specially formulated to supplement the specific nutritional needs of athletes with the aim of promoting better physical exercise performance”.

They can be presented in different forms such as tablets, capsules, powder, bars, gel or liquids, and can only be administered orally.

There are three types of supplements for sports people:

• Hydro-electrolytic supplements (suplementos hidroelectrolíticos): these are aimed at the hydro-electrolytic replacement.
• Energy supplements (suplementos calóricos): these are intended to supplement the energy needs.
• Protein supplements (suplementos protéicos): these are aimed at supplementing protein needs.

II. DIETARY SUPPLEMENTS

Additionally, the Food Department of the Ministry of Public Health is working on a regulation on dietary supplements (suplementos dietarios). These are therefore classified as foods.

The current draft regulation defines dietary supplements as: “products formulated to supplement the normal diet of healthy people where basic dietary needs are not met.”

III. REGISTRATION OF MODIFIED FOODS AND DIETARY SUPPLEMENTS IN URUGUAY

The sanitary registration requires the presence of the applicant at the Uruguayan Ministry of Public Health.

The premises of the importer or distributor also need to be registered with the Ministry of Public Health in order to continue with the product registration.

The following documentation must be submitted:

• Copies of the company registrations and in the case of imported products, certificates of free sale of origin, legalised or apostilled as appropriate.
• Two colour copies of the label (in real size) signed by the technical manager. If the product contains an insert label, it must also be attached.
• Filled application forms:
  • FO-13223-002 - Application form for the registration or renewal of food registration, signed by the legal representative and technical director;
  • FO-13223-004 - Form for qualitative-quantitative formula and nutritional information.
• Monograph of the product, signed by the technical manager with the following information:
• Name and brand of the product;
• Forms of presentation and net content;
• Qualitative-quantitative formulas (Annex 1 of Application form FO-13223-002)
• Nutritional information (Annex 2 of Application form FO-13223-002)
• Characteristics of the package;
• Storage conditions and proposed shelf-life. Studies carried out and conclusions of the stability of the product;
• Origin and specifications of the raw materials used;
• In the case of using raw materials of plant and/or animal origin, they must comply with the maximum limits for biological residual substances;
• If any of the components is of animal origin, the corresponding import authorization must be requested from the Ministry of Livestock, Agriculture and Fisheries;
• Flow diagram of the elaboration process indicating the Critical Points and Critical Control Points;
• Physicochemical and microbiological specifications of the finished product;
• Code for batch identification, its printing method and expiration date;
• Safety studies for new ingredients/foods: Safety data are not needed when the ingredients have been approved as new or novel food/ingredient by Brazil ANVISA or the EU;
• If it is not a new food/ingredient, but instead, there is a history of use, documented evidence of that use in the corresponding countries must be provided, showing its inclusion in specific Food Codes and providing information on the safety profile of the product.
• CD or pen-drive containing quali-quantitative formula and nutritional information in the Excel spreadsheet (FO-13223-004).
• Proof of payment showing the receipt number and the amount paid (cost is around 25,200 UYU/ 580 USD).

The sanitary registration is valid for 5 years.

IV. REGISTRATION OF MODIFIED FOODS AND DIETARY SUPPLEMENTS IN URUGUAY

All companies must be submit a “Statement on advertising of Dietary Supplements” to be able to market their products.

By filling out the declaration form FO-13223-013 (Declaración sobre publicidad de los suplementos dietarios), the legal representative and the technical director acknowledge that:

• Any used health claim corresponds to those approved by the Ministry of Public Health;
• The texts of label with which the product is marketed are those approved by the Ministry of Public Health in the registration process. In the event of any modifications, the company will make the corresponding "request for authorization of changes".
• Any advertising carried out in brochures, magazines, web pages and/or social networks, will only include the health claims that were duly approved during the registration of the product. The company will comply with the provisions, although it will not be necessary, in this case, to provide the texts of the materials for its evaluation.

The fees are 20 RUB.

V. CONTENT AND COMPOSITION OF SUPPLEMENTS FOR SPORTS PEOPLE

The Decree (Decreto) 330/014 establishes 3 types of supplements for sports people with the following requirements in their composition:

• Hydro-electrolytic supplements (suplementos hidroelectrolíticos):
  • The sodium concentration should be between 460 and 1150 mg/L in the product ready for consumption;
  • The addition of potassium up to 700 mg L is allowed;
  • The modality of the product ready for consumption must be less than 330 mOsm/kg of water;
  • Total carbohydrates must not exceed 8% (m/v) of the product ready for consumption;
  • The level of fructose, when added, should not exceed 3% (m/v) of the product ready for consumption;
  • The addition of other nutrients is not allowed;
  • The addition of starches and polyols is not allowed.
• Energy supplements (suplementos calóricos):
  • The product ready for consumption must contain 75% of the total energy value from carbohydrates;
  • The amount of carbohydrates must be at least 15 g per serving;
  • They can contain lipids, intact and/or partially hydrolysed proteins;
  • Saturated fats cannot exceed 10% of the values ​​established in Annex A of the Decree;
  • They cannot contain trans fatty acids.
• Protein supplements (suplementos protéicos):
  • The product ready for consumption must contain at least 50% of the total energy value from protein;
  • The product ready for consumption must contain a minimum of 10 g per serving of intact and/or partially hydrolysed proteins;
  • The biological value of proteins must not be less 70% of the amino acid values ​​listed in point 32.1.7 of the Decree.
• Additionally, the following do not fall under the scope of supplements for sports people:
  • Alcoholic and carbonated soft drinks;
  • Products that contain pharmacologically stimulating substances, hormones and others considered as "doping" substances;
  • Substances with a therapeutic or medicinal purpose, including herbal products;
  • Formulas with isolated amino acids, as unique nutrients;
  • Formulas containing added caffeine, except for ingredient sources that naturally contain it (with a limit for naturally containing caffeine of 20 mg per 100 g/ml.)
  • Formulas containing added creatine;
  • Formulas containing herbs or parts thereof, except those allowed as additives and flavouring substances;
  • The addition of dietary fibre is not allowed.

Vitamins and minerals

The addition of vitamins and minerals is allowed. They must provide between 15% and 100% of the Daily Recommended Intake in accordance with the values ​​listed in Annex A of the Decree.

The vitamins and minerals allowed are those listed in Annex B of the Decree.

VI. CONTENT AND COMPOSITION OF DIETARY SUPPLEMENTS

In accordance with the draft regulation on dietary supplements, dietary supplements may consist of a concentrated source of nutrients and/or other substances with a physiological effect, alone or in combination, including compounds such as vitamins, minerals, proteins, amino acids, components of plant origin, as well as their concentrates and extracts, probiotics, bioactive substances, among others.

The amount of ingredients must be lower than those needed for therapeutic dose.

The draft regulation also establishes minimum levels for protein, fibre and omega-3 fats, maximum levels for saturated fats and sodium and a ban on trans fats.

Additionally, the following do not fall under the scope of dietary supplements:

• Foods for medicinal use;
• Formulas and supplements for infants and young children;
• Products that contain added caffeine in its formulation - not from an ingredient or food that contains it naturally (with a limit for naturally containing caffeine of 100 mg/day);
• Products that contain creatine in their formulation.

Vitamins and minerals

The vitamins and minerals allowed are those approved by EU Regulation 1170/2009 and CODEX CAC/GL 10-1979.

Minimum levels of vitamin and minerals should correspond to 15% of the national Daily Reference Intake values, found in “Decree (Decreto) 117/006 implementing Mercosur Resolution 46/03 on the nutritional labelling of prepacked foods”.

Daily intake of vitamins and minerals should not exceed “No Observation of Adverse Effects Levels” (NOAEL), which is the maximum intake of a certain nutrient not associated with adverse effects (found in Annex B of the draft regulation on dietary supplements).

VII. GENERAL LABELLING REQUIREMENTS

For the general labelling of foods, including supplements, the Decree 117/2006 applies. This Decree implements the regional MERCOSUR food labelling regulations.

The MERCOSUR regulations are:

• MERCOSUR Resolution 26/03 on the labelling of prepacked foods;
• MERCOSUR Resolution 44/03 for the nutritional labelling of prepacked foods;
• MERCOSUR Resolution 46/03 on the nutritional labelling of prepacked foods;
• MERCOSUR Resolution 47/03 on the servings of prepacked foods.

Additionally, Uruguay has implemented through the “Decree (Decreto) 272/018” a front-of-pack warning system for foods and beverages high in total fat, saturated fat, sugar and sodium. Supplements for sports people and dietary supplements are excluded from this labelling scheme.

VIII. SPECIFIC LABELLING FOR SUPPLEMENTS FOR SPORTS PEOPLE

The Decree (Decreto) 330/014 requires that these products are generically named as “supplements for sports people (suplementos para deportistas)”, complementing the name according to their corresponding category:

• Hydro-electrolytic supplements (suplementos hidroelectrolíticos)
• Energy supplements (suplementos calóricos)
• Protein supplements (suplementos protéicos)

When the product is added with vitamins and/or minerals, the product name must be “supplements for sports people (suplementos para deportistas)”, followed by the corresponding category, and adding the list of vitamins and/or minerals, as appropriate.

The labelling and advertising of the products should not include images and/or expressions that:

• Mislead the consumer regarding properties and/or effects that they do not have regarding weight loss, muscle mass gain or the like;
• Refer to hormones and/or other pharmacological substances and/or on metabolism;
• The expressions: "anabolics", "muscle hypertrophy", "muscle mass", "fat burning", "anti catabolic", "anabolic" or others with the same meaning.

The recommended use should be indicated on the label.

The labelling of dietary supplements must comply with general labelling regulations, including warnings on particularly regulated ingredients.

The labelling of sports supplements should include specific warnings, such as: "This product is not a substitute for a balanced diet and its consumption should be guided by a doctor or nutritionist."

IX. SPECIFIC LABELLING FOR SUPPLEMENTS FOR DIETARY SUPPLEMENTS

In accordance with the draft regulation on dietary supplements, dietary supplements must be referred as “dietary supplements with (or based on) - (suplementos dietarios con (o a base de))” following the name of the ingredient or ingredients that compose it.

In the labelling and advertising of dietary supplements, including web pages and social networks, images and/or expressions cannot:

• Induce the consumer to associate the product with therapeutic functions;
• Indicate that the food has medicinal or therapeutic properties;
• Advise its consumption for reasons of stimulating action, health improvement or preventive or curative action;
• Be related to diseases, symptoms, syndromes, anatomical data or statements that affirm that the product covers by itself the nutritional requirements of the individual or that it can substitute some foods.

The recommended use should be indicated on the label.

The labelling of dietary supplements must comply with general labelling regulations, including warnings on particularly regulated ingredients.

The draft regulation on dietary supplements also foresees the indication of specific warnings, such as: "This product is not a substitute for a balanced diet" or "Do not use in case of pregnancy, lactation or children".

X. CLAIMS

Nutrition claims are regulated by “Decree 402/2012 (Decreto 402/2012)” which implements the “MERCOSUR Resolution 01/2012 on complementary nutrition information”.

Permitted health claims are those authorised and published in the Official Journal of the EU, Brazil ANVISA, Health Canada and US FDA.