TITLE XXIX [1][2]
FOOD SUPPLEMENTS AND FOODS FOR ATHLETES [3]
Paragraph I
Food Supplements
ARTICLE 534.- Dietary supplements are those products specially elaborated or prepared for health-related purposes to supplement the diet and help maintain or protect characteristic physiological states such as adolescence, adulthood, or old age.
Their composition may correspond to a nutrient, mixture of nutrients, and other components naturally present in foods, including compounds such as vitamins, minerals, amino acids, lipids, dietary fiber, or their parts.
They may be expended in various conventional release forms, such as powders, liquids, granules, pills, caplets, tablets, capsules, or other forms characteristic of medications.
ARTICLE 535.- The dietary ingredients for food supplements, which are the substances intentionally used to supplement the human diet by increasing the total daily intake of vitamins, minerals, amino acids, lipids, dietary fiber or other elements naturally present in foods, must comply with the identity and purity indicated in the specifications for quality and innocuousness.
ARTICLE 536.- The statement of health and nutritional properties, and the complementary nutritional information described on the packaging of these products, must adhere to the rules established for this purpose in these Regulations. The promotion of consumption for purposes of diagnosis, prevention or treatment of diseases is prohibited. [4]
ARTICLE 537.- Advertising, through any medium, as well as the labeling of dietary supplements must comply with the rules on the matter referred to in these Regulations; in addition, these products must state on the label, prominently on the front of the packaging and after the product name, its classification as "Food supplement."
All food supplements must include, immediately below the labeling as "Food Supplement," a statement indicating: "Its use is not recommended for use by children under 8 years of age, pregnant and lactating women, unless otherwise indicated by a competent professional, and it does not replace a balanced diet."
ARTICLE 538.- The maximum and minimum levels of vitamins, minerals, and other components referred to in Article 534 shall be established by resolution of the Ministry of Health, issued in exercise of its technical regulatory legal powers.
Paragraph II [5]
Foods for Athletes
ARTICLE 539.- Foods for athletes are those food products formulated to meet the requirements of healthy individuals, especially those who undertake heavy and prolonged exercise.
These foods shall be composed of a food ingredient or mixture of them. One or more nutrients, such as carbohydrates, proteins, vitamins, minerals, and other compounds naturally present in foods, such as caffeine or those expressly authorized in these Regulations, may be added to them. In its preparation, the standards of good manufacturing practices must be met.
They cannot have, alone or jointly, hormones or compounds with an anabolic effect. Nor may substances be added that have a stimulating effect on the nervous system, except those which are specifically authorized and within the limits permitted for this type of food in these Regulations.
ARTICLE 540.- Foods for athletes may only be considered to be those that meet the requirements of any of the nutritional properties listed below. They shall include in the label, on the main panel of the packaging, in easily legible letters whose color contrasts with the background of the label: "FOOD FOR ATHLETES...... " with the descriptor shown in quotation marks, as appropriate:
a)"High-energy. "Those foods for which the average serving size contains 30% or more of the daily reference value (DRV) for energy (DRV = 2000 Kcal/day). [6]
b)"Good source of energy."Foods for which the average serving size contains between 20% and 29% of the daily reference value for energy.
c)"High in available carbohydrates."Foods for which the average serving size contains 30% or more of the daily reference value for available carbohydrates (DRV = 350 g available carbohydrates/day).
d)"Good source of available carbohydrates."Foods for which the average serving size contains between 20% and 29% of the daily reference value for available carbohydrates.
e)"Rich in proteins."Foods for which the average serving size contains 40% or more of the daily reference value for proteins equivalent to an optimum quality and digestibility (DRV = 50 g of proteins).
f)"Good source of proteins."Foods for which the average serving size contains between 20% and 39% of the DRV for proteins equivalent to an optimum quality and digestibility.
g)"With added amino acids."These foods may have the amino acids indicated below added to them, up to the maximum daily amounts listed. In the consumption recommendation on the label, the maximum amounts per day as indicated in each case may not be exceeded.
Amino acid / Maximum daily amount mgAlanine / 4800
Arginine / 4400
Aspartic acid / 2400
Cysteine / 1800
Glutamine / 5600
Glutamic acid / 6400
Glycine / 6000
Histidine / 1700
Isoleucine / 1400
Leucine / 1900
Lysine / 1700
Methionine / 720
Ornithine / 1400
Phenylalanine / 1900
Proline / 4400
Serine / 5600
Taurine / 1500
Threonine / 1000
Tyrosine / 1600
Tryptophan / 100
Valine / 1400
Foods that have phenylalanine must include in the label the following message: "Phenylketonurics: Contains Phenylalanine." Foods with a taurine content equal to or greater than 500 mg per serving size must include in the label the following message: "Not recommended for diabetics."
h)"With added electrolytes."Foods that are presented as non-alcoholic beverages or preparations to be reconstituted may contain electrolytes such as sodium and/or potassium. The sodium content must be equal to or greater than 10 mmol/l (230 mg Na+/l); the potassium content must be equal to or greater than 2 mmol/l (78 mg K+/l). These beverages may be isotonic or hypotonic, and should be formulated to have a minimum osmolality of 200 mosm/kg of water and a maximum of 340 mosm/kg of water.
Beverages presenting an osmolality between 200 and 250 mosm/kg of water may be designated as: "hypotonic," and those presenting an osmolality between 250and 340 mosm/kg of water may be designated as "isotonic."[7]
The consumption recommendation for "Foods for Athletes" that is labeled, attached, or related to the product must not exceed, per day, the amounts of sodium and potassium which are listed below:
Electrolyte / Maximum daily amountmmolmg
Sodium / 70 / 1610
Potassium / 95 / 3715
i)"With added vitamins and/or minerals."If vitamins and/or minerals are added, these food products should be classified accordingly as "Fortified Food" or "Food Supplement," respecting the limits for each nutrient in each category.
When a "Food for Athletes" also qualifies as a "Food Supplement," it shall comply with the relevant articles of these Regulations, especially, but not only, as provided in Paragraph I of Title XXIX.
j)With caffeine. Caffeine may be incorporated in pure form or by addition of one or more food ingredients containing it. Of these, only the following ingredients may be used: coffee (Coffea spp.), green tea or black tea (Camellia sinensis or Thea sinensis), cocoa (Theobroma cacao), yerba mate (Ilex brasillensis and Ilex paraguariensis), kola nut (Kola spp.), and guarana (Paullinia cupana), as such or in the form of extracts. The consumption recommendation on the label and/or advertising may not exceed 500 mg of caffeine per day.
k)With the addition of other compounds. Foods for athletes may have the ingredients listed below added to them, allowing for the maximum amounts per average serving size as established. The consumption recommendation that is labeled, attached, or related to the product must not exceed the maximum amounts per day indicated in each case. These foods must use the descriptor: "With ...... ," indicating the name of the ingredient, as appropriate; thus, for example, if it has added L-carnitine and choline, the following descriptor should be used: "With L-carnitine and choline."
Food ingredient / Maximum daily amountL – carnitine / 2 g
Inosine / 10 mg
Ubiquinone / 15 mg
Creatine / 5 g
Delta-gluconolactone or Glucono-delta-lactone / 600 mg
l)With herbs: Herbs and/or extracts of herbs listed below may be incorporated as food ingredients, in the maximum amounts per average serving size established. The consumption recommendation for "Foods for Athletes" that is labeled, attached, or related to the product must not exceed the maximum amounts per day indicated in each case.
Food ingredient / Maximum daily amountPanax Ginseng Root C. A. Meyer (Korean Ginseng, Asian Ginseng, or Oriental Ginseng) / 1.0 g of root
Chinesis Schizandra Fruit (Turcz.) Baill. (Chisandra) / 1.5 g of fruit
Root and rhizome of Eleutherococcus senticosus Rupr. et Maxim. (Siberian Ginseng) / 2.0 g of root and rhizome
If these ingredients are incorporated in the form of extracts, they should be suitable for use in foods, and their maximum concentration must be calculated considering the equivalence of the content specified in each of the forms included in this table.
In foods that contain one or more of these herbs, the maximum content of caffeine in the product ready for consumption shall be 54 mg per average serving size and not to exceed 180 mg of caffeine/liter in food consumed in liquid form and 90 mg/100 g in solid food.
ARTICLE 541.- Foods for athletes shall be labeled according to the general labeling provisions and as provided in Articles 110 and 540 of these Regulations.
Those with added amino acids, L-carnitine, choline, inosine, ubiquinone, creatine, herbs, or extracts of Panax ginseng C. A. Meyer, Schizandra chinesis (Turcz.) Baill., Eleutherococcus senticosus Rupr. et Maxim, or whose caffeine content is higher than 180 mg/l in liquid foods and greater than 90 mg/100 g in solid foods, must include a caption that states: "NOT RECOMMENDED FOR CHILDREN UNDER 15 YEARS OF AGE, DURING PREGNANCY OR BREASTFEEDING" in uppercase, bold letters (prominent). [8]
[1] Title incorporated, as it appears in the text, by Decree No. 287/01, of the Ministry of Health, published in the Official Gazette on February 18, 2002
[2] Exempt Resolution No. 394/02, of the Ministry of Health, published in the Official Gazette on March 1, 2002, sets the Dietary Supplement Nutritional Guidelines and their vitamin and mineral content
[3] Name modified, as it appears in the text, by Decree No. 253/02, of the Ministry of Health, published in the Official Gazette on January 20, 2003
[4] Article amended, as it appears in the text, by Decree No. 57/05, of the Ministry of Health, published in the Official Gazette on May 6, 2005
[5] Paragraph II, added, as indicated in the text, by Decree 253/02, of the Ministry of Health, published in the Official Gazette on January 20, 2003
[6] Letter amended, as it appears in the text, by Article 1, No. 15 of Decree 24/11, of the Ministry of Health, published in the Official Journal on November 24, 2011
[7] Letter amended, as it appears in the text, by Article 1, No. 34, of Decree 68/05, of the Ministry of Health, published in the Official Gazette on January 23, 2006
[8] Final paragraph deleted, by Decree No. 57/05, of the Ministry of Health, published in the Official Gazette on May 6, 2005
EFFECTIVE: Provisional Article Decree 57/05: This Decree will enter into force eighteen months after its publication in the Official Gazette. Notwithstanding the aforementioned, the health authority may, by substantiated resolution, authorize the marketing of food products that do not meet the provisions of this supreme Decree regarding labeling, for a maximum period of up to twelve additional months, provided that the extension request is filed before the expiration of the period of eighteen months. Exceptionally, for foods marketed in returnable containers this Decree will enter into force thirty six months after the date of its publication in the Official Gazette, a period which may not be extended.