Resolution - RDC nº 40, 21 march 2001

The Associated Directors of the National Sanitary Surveillance Agency (ANVISA), by the powers granted to them in Article 1 insert IV of the ANVISA Regulation approved by Decree No. 3.029, 16 April 1999, according to the 1st paragraph of article 111 of the Internal Regulation approved by Edict No. 593, 25 August 2000, republished in the Official Diary of the Union (DOU) of 22 December 2000, at a meeting which took place on 20 March 2001,

considering it necessary for the population’s health that actions related to the sanitary control of food be constantly improved;

considering the prevalence of nutritional diseases in the Brazilian population;

considering the guidelines established in the National Food and Nutrition Policy;

considering it necessary to establish actions to help consumers choose a healthy diet;

and considering it necessary to standardize the expression of nutrition facts for Obligatory Nutritional Labeling of Packaged Foods and Beverages,

has adopted the following Associated Directors’ Resolution and I, The Director-President, order its publication:

Art. 1 To approve the Technical Regulation for OBLIGATORY NUTRITIONAL LABELING OF PACKAGED FOODS AND BEVERAGES, attached to this Resolution.

Art. 2 Businesses have a period of 180 (one hundred and eighty) days counting from the date of this Regulation’s publication within which to comply with same.

Art. 3 Failure to fulfill the terms of this Resolution constitutes a sanitary infraction subject to the provisions determined by Law No. 6.437, 20 August 1977 and any other applicable measures.

Art. 4 This Resolution enters in force on the date of its publication.

Art. 5 The following are hereby revoked: Edict SVS/MS No. 41, 14 January 1998, published in the Official Diary of the Union (DOU) on 21 January 1998; Resolution RDC No. 94, 1 November 2000, published in the DOU on 3 November 2000; and item 7.3 of Edict SVS/MS No. 42, 14 January 1998, published in the DOU on 16 January 1998.

GONZALO VECINA NETO

ATTACHMENT

TECHNICAL REGULATION FOR OBLIGATORY NUTRITIONAL LABELING OF PACKAGED FOODS AND BEVERAGES

1.SCOPE

1.1 Objective

Standardize the expression of nutrition facts for the Obligatory Nutritional Labeling of Packaged Foods And Beverages.

1.2 . Extent of Application

The present Technical Regulation, disregarding the rules established in the legislation for Packaged Food Labeling, applies to the Obligatory Nutritional Labeling of Foods And Beverages which are produced, commercialized and packaged in the absence of the client, and are ready to be offered to consumers.

Excluded from this Regulation are mineral waters and other bottled waters destined for human consumption, as these products have their own regulations which permit listing mineral and nutritional characteristics on the label. Alcoholic drinks are also excluded.

2. DEFINITIONS

2.1. Nutritional Labeling: any description whose purpose is to inform the consumer about nutritional properties of a food. Nutritional Labeling includes two components:

a) Nutrition Facts; and

b) Complementary Nutrition Facts.

2.1.1.Nutrition Facts: a description or ordered listing of a food’s nutrients.

2.1.2. Complementary Nutrition Facts(declaration of nutritional properties): any representation that affirms, suggests or implies that a product possesses specific nutritional properties, particularly – but not only – in relation to its caloric value and its carbohydrate, protein, fat and dietary fiber content, as well as its vitamin and mineral content.

The following are not considered Complementary Nutrition Facts:

a) the mention of substances in the ingredients list;

b) the mention of nutrients as an obligatory part of nutritional labeling; and

c) the presence on the label, when national legislation demands, of the quantitative or qualitative declaration of certain nutrients or ingredients or calories, until a specific technical regulation has been determined.

2.2.Simplified Nutrition Facts: the description or ordered listing of a group of nutrients of a particular food, when that food contains a certain number of nutrients in insignificant quantity.

2.3. Nutrient: any chemical substance normally consumed as a component of a food, and which:

a) provides energy, and/or:

b) is necessary for growth, development and maintenance of health and life, and/or

c) by its absence, produces chemical changes or physiological characteristics.

2.4. Proteins: compounds formed by amino acids.

2.5. Fats: all lipids, including phospholipids.

2.6. Saturated fats: fatty acids without double bonds.

2.7. Monounsaturated fats: fatty acids with one cis double bond.

2.8. Polyunsaturated fats: fatty acids with cis-cis double bonds separated by a methylene radical.

2.9. Carbohydrates: all carbohydrates metabolized by human beings, including polysaccharides.

2.10. Sugars: all monosaccharides and disaccharides metabolized by the human organism. Does not include polysaccharides.

2.11. Dietary fiber: any edible material not hydrolyzed by the internal enzymes of the human digestive tract, as determined by methods published by the AOAC in its most recent issue.

3. GENERAL PRINCIPLES

3.1. Obligatory Declaration of Caloric Value, Nutrients and Components

3.1.1. In the obligatory declaration of calories, nutrients and components, quantitative information must be listed in the following order:

3.1.1.1. Caloric Values

3.1.1.2. The following nutrients and components:

Carbohydrates

 Protein

 Total fat

 Saturated fat

 Cholesterol

 Dietary fiber

 Calcium

  Iron

 Sodium

3.1.1.3. When required by specific technical regulations, the Quantity of any other nutrients considered important to maintain a good nutritional state.

3.1.1.4. The quantity of any other nutrients about which a declaration of properties is made.

3.1.2. Other nutrients and components may be declared optionally. Declaration of vitamins and minerals is treated in item 3.1.5.

3.1.3. When Complementary Nutrition Facts are indicated in relation to the quantity or type of a carbohydrate, the total quantity of sugars, beyond what is anticipated by item 3.1.1., must be declared. Quantities of starch and other carbohydrate constituents may be indicated.

3.1.4. When Complementary Nutrition Facts are indicated in relation to quantity or type of fatty acids, the quantities of monounsaturated and polyunsaturated fats (fatty acids) must be indicated in the manner established by item 4.1.2.

3.1.5. Besides those items on the obligatory declaration indicated in item 3.1.1., those vitamins and minerals listed in the specific Technical Regulation on Reference Daily Intake (RDI) will be listed only when those nutrients are present in quantities of at least 5% of RDI per serving.

3.1.6. When specific technical regulations require the declaration of lipid content and/or carbon hydrates , the change of terminology to fats and carbohydrates may be done gradually.

3.2. Calculations

3.2.1. Calculation of Caloric Value

The caloric value to be declared is calculated according to the following conversion factors:

Suitable factors, not anticipated above, may be used for other items which will be indicated in specific technical regulations.

3.2.2. Calculation of Nutrients

3.2.2.1. Carbohydrates

This is calculated as the difference between 100 and the sum of the protein, fat, dietary fiber, moisture and ash contents.

3.2.2.2. Protein

The quantity of protein indicated is calculated according to the following formula:

Protein = total nitrogen content (KJELDAHL) x corresponding factor, as determined by type of food, utilizing the following factors:

5.75 vegetable proteins

6.25 meat or mixed proteins

6.38 milk proteins

A different factor may be used when indicated in a specific technical regulation.

4. DECLARATION OF CALORIES, NUTRIENTS AND COMPONENTS

4.1. The declaration on the label of calories, nutrient content and components must be made in numerical form. This information must also be declared in Percent Daily Values (%DV). These Daily Values have been established using Daily Reference Values (DRVs) presented in item 4.2, which are based, according to each case, on Reference Daily Intake (RDI).

4.2. For the purpose of presenting nutrition facts in Percent Daily Values, the following Daily Reference Values, based on a 2500-calorie diet, have been established:

Carbohydrates 375 grams

Total fat 80 grams

Saturated fat 25 grams

Cholesterol 300 milligrams

Dietary fiber 30 grams

Sodium 2,400 milligrams

In the case of protein, vitamins and minerals, the values on the attached Tables of the specific Technical Regulation on Reference Daily Intake should be used.

4.3 The units to be utilized in the declaration of calories, nutrients and components are as follows:

4.4. It is obligatory for nutrition facts (declaration of caloric value and dietary fiber and nutrient content on the label ) to be expressed in servings and in Percent Daily Values. Moreover, nutrition facts may be expressed in quantities per 100 grams or 100 milliliters.

4.5. The serving sizes to be adopted are those established in the specific Technical Regulation for Packaged Food and Beverage Serving Sizes for Nutritional Labeling.

4.6. The Ministry of Health may establish, as a specific Technical Regulation, criteria for the classification of foods according to fat content.

4.7. The quantities mentioned must correspond to the actual form in which a food is displayed for sale. It is also possible to provide complementary information with respect to the food in its prepared state, as long as sufficiently detailed preparation instructions are given, and the information refers to the food in a state ready for consumption.

4.8. When a food’s specific Technical Regulation requires the declaration of nutrients per 100 g or 100ml of the product displayed for sale and/or the product ready for consumption, this information must be presented per serving, disregarding the terms of item 4.4. Intestinal regulators are excluded from the declaration-per-serving requirement.

4.9. Packages with a total area of less than 80 cm² available for labeling are exempt from having to provide nutrition facts. The label must contain a printed alert, declaring, "FOR NUTRITION FACTS: _______", completing the phrase with the company’s telephone number or complete address. To either of these pieces of information may be added an e-mail address. This exemption does not apply when complementary nutrition facts are declared or when nutrition facts are required by a specific technical regulation.

4.10. The Simplified Nutrition Facts may be utilized when a food presents insignificant quantities, according to Table 1A "Rounding Off of Nutrients", of at least 5 of the following items; Calories, Carbohydrates, Protein, Total Fat, Saturated Fat, Cholesterol, Dietary Fiber, Calcium, Iron and/or Sodium. Declaration of Calories, Carbohydrates, Protein, Total Fat and Sodium is obligatory, regardless of whether the quantity is insignificant.

4.11. Nutritional information concerning Saturated Fat and Cholesterol must be listed in the Simplified Nutrition Facts when fat is responsible for 30% or more of a food’s Caloric Value.

4.12. Whenever a quantity or type of fat (fatty acid) is declared, this declaration will immediately follow the total fat content, in the following manner:

4.13. Whenever the content of sugars and/or polysaccharides and/or starch and/or polydextrose and/or other carbohydrates is declared, this declaration immediately follows carbohydrate content, in the following manner:

The declaration "other carbohydrates" refers to any other carbohydrate, all of which must be clearly identified.

4.14. The declared values of nutrients and components must obey the rounding-off parameters established in Table 1 of this regulation. This rule does not apply to artificial sweeteners.

4.15. Daily Values must be declared in whole numbers, decimals being rounded off the following way: from one to five, round off to zero; above five, round off to the next whole number.

5. DATA ACQUISITION

5.1. The fixed values of nutrition facts, for which the manufacturer is responsible, may be obtained by means of:

5.1.1. Average values of specific data obtained from physical-chemical analyses of representative samples of the product to be labeled.

5.1.2. National Food Composition Tables and Food Composition Data Banks. In the absence of data from national food composition tables and data banks, international tables and data banks may be used.

5.2. A tolerance is permitted of up to 20% over or under for the fixed nutrition facts declared on the label.

5.2.1. For nutrients whose variability percentage, due to species and type of agricultural handling, is greater than the tolerance established in item 5.2., the manufacturer may indicate percentage of variation beneath the nutrition facts table.

5.2.2. In the case of item 5.2.1., the manufacturer must maintain available the studies which justify the variability percentage of the nutrient(s) informed on the label.

6. COMPLEMENTARY NUTRITION FACTS

6.1. The purpose of Complementary Nutrition Facts are to facilitate the consumer’s understanding of a food’s nutritional value, and to help him/her interpret the nutrition facts.

6.2. Complementary Nutrition Facts may only be used when a specific technical regulation has been established.

6.3. The use of Complementary Nutrition Facts on labels of packaged foods and beverages is optional, and must not substitute, but may supplement, the required nutrition facts.

7. PRESENTATION OF NUTRITION FACTS

7.1. Nutrition Facts must always be presented in the same place, structured in the form of a table (a vertical or horizontal rectangle, depending on the size of the label) and, if space is insufficient, in linear form as shown in the attached model.

7.2. The information must be in a visible place, with legible and indelible printing.

7.3. Nutrition facts must be presented according to the following rules and distinctions:

a) The expression "Nutrition Facts" must be written in boldface, using a font larger than those used to express the other information listed on the table.

b) The expression "Serving size" must be written directly below "Nutrition Facts" in the same size font as the other information contained in the table.

c) If the manufacturer provides a household measurement corresponding to the food’s established serving size, it should be written in parentheses alongside the value indicated for the serving size.

d) The expression "Calories" must be written in the same size font as the other information contained in the table. Caloric value, expressed as calories, must be placed alongside.

e) The expressions: "Carbohydrates", "Protein" and "Total Fat" must be written in the same size font as the other information contained in the table. The quantities of carbohydrates, protein and total fat, expressed in grams (g), must be placed alongside.

f) The expression "Saturated Fat" must be written in the same size font as the other information contained in the table. The quantity of saturated fat, expressed in grams (g), must be placed alongside.

g) Whenever the expressions "Saturated", "Monounsaturated", and "Polyunsaturated" are declared, they must be listed one below the other, in the same size font as the other information contained in the table. The quantity, expressed in grams (g), must be placed alongside.

h) The expression "Cholesterol" must be written in the same size font as the other information contained in the table. The quantity of cholesterol, expressed in milligrams (mg), must be placed alongside.

i)Whenever the expressions "Sugars", "Polysaccharides", "Starch", "Polydextrose" and other carbohydrates are declared, they must be listed one below the other, directly beneath the expression "Carbohydrates", in the same size font as the other information contained in the table. The quantity, expressed in grams (g), must be placed alongside.

j) The expression "Dietary Fiber" must be written in the same size font as the other information contained in the table. The quantity of dietary fiber, expressed in grams (g), must be placed alongside.

k) The expression "Calcium" must be written in the same size font as the other information contained in the table. The quantity of cholesterol, expressed in milligrams (mg) or micrograms (mcg), must be placed alongside.

l) The expression "Iron" must be written in the same size font as the other information contained in the table. The quantity of iron, expressed in milligrams (mg) or micrograms (mcg), must be placed alongside.

m) The expression "Sodium" must be written in the same size font as the other information contained in the table. The quantity of sodium, expressed in milligrams (mg), must be placed alongside.

7.4. The Percent Daily Values must be placed to the right of the quantities indicated for calories, nutrients and components.

7.5. The expressions must be listed in sequence and separated by lines as shown in the Model attached to this Regulation.

7.6. All other declared nutrients and components should follow the same rules as those for Obligatory Nutritional Information.

8. REFERENCES

8.1. BRAZIL. Decree-Law No. 986, 21 October 1996. Institutes basic standards for foods. Official Diary of the Union, Brasilia, 21 October 1996. Section 1, pt.1.

8.2. MINISTRY OF MINES AND ENERGY. Edict No. 1628, 4 December 1984. Institutes basic labeling features for bottles of mineral water and other drinking water. Official Diary of the Union, Brasilia, 5 December 1984. Section 1, pt. 1, p. 18083.

8.3. BRAZIL. Law No. 8.543, 23 December 1992. Determines the printing of a warning on labels and industrially packaged foods that contain gluten. Official Diary of the Union, Brasilia, 24 December 1992. Section 1, pt. 1.

8.4. BRAZIL. Edict SVS/MS No. 27, 14 January 1998. Technical Regulation referring to Complementary Nutrition Facts. Official Diary of the Union, Brasilia, 16 January 1998. Section 1, pt. 1.

8.5. BRAZIL. Edict SVS/MS No. 33, 13 January 1998. Reference Daily Intake (RDI) Tables. Official Diary of the Union, Brasilia, 16 January 1998. Section 1, pt. 1.

8.6. BRAZIL. Edict SVS/MS No. 42, 14 January1998. Technical Regulation for Labeling of Packaged Foods. Official Diary of the Union, Brasilia, 16 January 1998. Section 1, pt. 1.

8.7. BRAZIL. Law No. 9.782, 26 January 1999. Defines the National Sanitary Surveillance System, creates the National Sanitary Surveillance Agency and creates other provisions. Official Diary of the Union, Brasilia, 27 January 1999.

8.8. BRAZIL. ANVS Resolution No. 309, 16 July 1999. Technical Regulation for Setting Standards for the Identity and Quality of Purified Water with Added Salts. Official Diary of the Union, Brasilia, 19 July 1999, Section No. 136-E, p. 26.

8.9. BRAZIL. Resolution No. 23, 15 March 2000. Technical Regulation concerning the Manual of Basic Procedures for the Registration and Exemption of the Obligatory Registration of Products Related to the Food Area. Official Diary of the Union, Brasilia, 16 March 2000. Section 1, pt. 1.

8.10. BRAZIL. Resolution-RDC No.54, 15 June 2000. Technical Regulation for Fixing the Identity and Quality of Natural Mineral Water and Natural Water. Official Diary of the Union, Brasilia, 19 June 2000. Section 1, pt. 1.

8.11. FOOD AND DRUG ADMINISTRATION, Department of Health and Human Services. Food Labeling. Code of Federal Regulations, Title 21, Parts 100 to 169. 21CFR101.9.

9. TRANSITORY MEASURES

9.1. Exempt from the payment of corresponding fees, small businesses can make use of Official Public Health Laboratories for the realization of specific complementary analyses of foods whose nutrients are not available in Food Composition Tables or Data Banks.

9.2. Commercial establishments permitted to sell foods in bulk have the option of declaring the foods’ calories, nutrient and dietary fiber content on posters, folders, tags or other appropriate formats.

TABLE 1 – ROUNDING OFF OF NUTRIENTS

A) OBLIGATORY NUTRITION FACTS

(**) Example of rounding off (to the closest 1.0 g)

from 2.01 to 2.49 g round off to the lower corresponding value (2.0 g)

from 2.50 to 2.99 g round off to the higher corresponding value (3.0 g)

B) OPTIONAL NUTRITION FACTS

(**) Vitamins and minerals other than calcium, iron and sodium must be declared if they are nutrient additives or supplements, or if allegations of a specific property are made.

NUTRITION FACTS MODEL COLOCAR COMO O MODELO DA VERSÃO ORIGINAL (DESENHO)

A) Vertical Model

* Daily Reference Values are based on a 2,500-calorie diet.

(1) when declared

B) Horizontal Model COLOCAR COMO O MODELO DA VERSÃO ORIGINAL (DESENHO)

* Daily Reference Values are based on a 2,500-calorie diet.

(1) when declared

C) Linear Model

Nutrition Facts: Serving Size ___ g/ml (household measurement)(1) Calories…. Cal (%DV*); Carbohydrates …g (%DV); Protein …g (%DV); Total Fat…g (%DV); Saturated Fat …g (%DV); Cholesterol …mg (%DV); Dietary Fiber …g (%DV); Calcium …mg (%DV); Iron …mg (%DV); Sodium …mg (%DV). Other minerals and vitamins (1)

* Daily Reference Values are based on a 2,500-calorie diet.

(1) when declared

D) Simplified Nutrition Facts

 * Daily Reference Values are based on a 2,500-calorie diet.