Resolution - RDC nº 39, 21 march 2001

The Associated Directors of the National Sanitary Surveillance Agency (ANVISA), by the powers granted to them in art. 11 insert IV of the ANVISA Regulation approved by Decree No. 3.029, 16 April 1999; at a meeting held on 20 March 2001, considering it necessary for the population’s health that actions related to the sanitary control of food be constantly improved;

and considering it necessary to establish serving sizes for packaged foods and beverages, for the purpose of nutritional labeling,

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

Art. 1 To approve the Packaged Food and Beverage Serving Size for Food Labeling Reference Table attached to this Resolution.

Art. 2 This Resolution enters in force on the date of its publication.

GONZALO VECINA NETO

ATTACHMENT

PACKAGED FOOD AND BEVERAGE SERVING SIZE FOR FOOD LABELING REFERENCE TABLE

1. DEFINITIONS

1.1 The Serving Size is the average quantity of a specific food usually consumed at one serving as part of a healthy diet by a healthy, well-nourished person over 5 years old.

1.2 The Food Pyramid is a graphic tool whose purpose is to orient the population towards a healthier diet. It is composed of 4 levels containing 8 major food groups, each shown in proportion to its relative contribution to the total number of calories contained in a healthy diet, as follows:

Level 1 (base) – Group 1: Breads, cereals and cereal products, other grains, roots and tubers = 8 servings daily

Level 2 – Group 2: Vegetables = 3 servings daily; Group 3: Fruits and fruit juices = 3 servings daily

Level 3 – Group 4: Milk and Dairy Products = 3 servings daily; Group 5: Meats and Eggs = 2 servings daily; Legumes = 1 serving daily.

Level 4 – Group 7: Fats and oils = 2 servings daily; Group 8; Sugar, candy, chocolate, snack foods = 2 servings daily.

2. METHODOLOGY

2.1 Foods and beverages were grouped in major categories according to their classification in the food pyramid.

2.2. Each major food group’s caloric contribution to a diet totalling 2500 calories was calculated according to the Ministry of Health’s Dietary Guidelines for the Brazilian Population , as follows:

a) group 1 includes products with a high complex carbohydrate content. A healthy diet should obtain 55% of its total calories from carbohydrates. The recommended consumption for this group is 8 daily servings of approximately 150 calories each. The attached Table 1 refers to this food group.

b) group 2, consisting of vegetables, and group 3, consisting of fruits, contribute significant amounts of micronutrients (vitamins and minerals) and should provide about 10% of the total calories of a healthy diet. The recommended daily consumption is 3 servings of approximately 15 calories each of vegetables, and 3 servings of approximately 70 calories each of fruits. Attached Tables II and III refer to these food groups.

c) group 4, consisting of milk, cheese and dairy products; group 5, consisting of meats and eggs; and group 6, consisting of legumes, provide protein in a healthy diet. Considering that approximately 15% of total daily calories should come from proteins, the recommended consumption for these groups is as follows: group 4 - 3 servings of approximately 120 calories each; group 5 - 2 servings of approximately 130 calories each; and group 6 - 1 serving of approximately 55 calories. The total contribution of these three food groups may exceed 15% of the total calories of the daily diet, since they possess nutrients from other food groups as well, most notably fats. Attached Tables IV, V and VI refer to these food groups.

d) group 7, fats and oils, and group 8, sugar, candy, chocolate and snack foods possess high caloric density. These foods have a place in a healthy diet if consumed in moderation. The Dietary Guidelines for the Brazilian population recommend a daily consumption of two servings from each group, with each serving corresponding to 120 calories and 80 calories, respectively. In a healthy diet, fats should contribute 20-25% of the total caloric content, without exceeding 30%. The fats and oils group contributes about 10% of this total, the rest coming from other food groups in which are found significant amounts of fat, particularly the meat/egg group and the milk and dairy product group. Attached Tables VII and VIII refer to these food groups.

2.3. The average calories per serving of each food group were used to define the serving size reference, in grams or milliliters, for packaged foods and beverages, based on the average caloric values of each one of these products. A variability factor of about 20% for the caloric participation of each group was allowed.

2.4. The calculated values were then rounded upwards to the nearest multiple of 5, examples: 32 = 35; 47 = 50.

2.5. Other food products which could not be classified within these 8 major categories have been included in 2 other categories named "other sauces, soups and ready-to-eat foods" and "coffee, tea, spices and miscellaneous". Given that the products in these categories exhibit a wide range of caloric values, that most of them constitute a minimal caloric contribution and that the products highest in calories on these two lists are not, for the most part, consumed on a daily basis, serving sizes were established according to typical habits of consumption. Attached Tables IX and X refer to these products.

2.6. In the case of products that reach the consumer in individualized packages, each package is considered to be an average single serving, and is used as the serving size for nutritional labeling.

2.7. In the case of those products usually utilized as ingredients in other food preparations, or in caloric quantities smaller than those of its group, the serving should correspond to the quantity, per person, usually utilized in the most common preparations, and not to the caloric total of the group.

2.8. In Brazil, both fresh and dry pasta products are commonly consumed as a main dish. Therefore, a pasta meal is considered as 2 servings of group 1 in the food pyramid, and its serving size corresponds to approximately 300 calories.

2.9. For products that contain 2 (two) phases, the serving size applies to the drained product, except in cases where both the solid and liquid content are usually consumed.

2.10. The manufacturer may present nutrition facts for a prepared serving of a food product, providing that specific, sufficiently detailed preparation instructions are given, and that the information refers to the food in a state ready for consumption.

2.11. The term "unit" is used as a generic description to designate an individual serving. Manufacturers should use the unit description most appropriate for the specific product (examples: bar – for cereal bar; slice – for a serving of cake).

3. SERVING SIZE DESCRIPTION ON LABELS

3.1. The values presented in the tables are the serving sizes references used to establish the serving sizes that will appear on the labels of packaged foods and beverages.

3.2. Manufacturers should present serving sizes on the label in grams and milliliters, as well as in the household measurement most appropriate for the specific product. For products whose serving size is presented as a designated "unit", the equivalent in grams should be indicated in parentheses.

a) when serving sizes are presented in grams or milliliters and household measurements, the latter should be placed in parentheses preceded by its corresponding number of units or fractions there of [example: uncooked white rice, 50g (1/4 cup)].

b) the labels of products whose serving sizes are calculated in units should utilize the term for unit most appropriate to describe an individual serving of the specific product.

The unit’s equivalent in grams or milliliters should be included in parentheses immediately following the designated term for unit: 1 unit ( x grams or x milliliters).

c) when the manufacturer opts to present the household measurement in parentheses following the serving size in grams, the measure used should be that presented on the table, rounding off according to the pre-established terms.

d) when the manufacturer’s indication of the average weight of a particular product’s household measure differs greatly from that presented on the table, a different average weight can be used, providing the manufacturer maintains records of the measurements that confirm the weight presented on the label.

e) the number of household measures corresponding to a serving size in grams or milliliters can be represented by a combination of whole values and fractions thereof, or a rounded off number.

f) tablespoons are rounded to the nearest whole or half, while cups are calculated by wholes, halves, thirds and quarters, according to the nearest fraction established by the following criteria:

g) when the serving size is presented in grams but the household measure is indicated by a unit (example: cookies), the manufacturer’s average weight in grams per unit should be used, rounding off units to the whole number nearest the fraction, according to the following:

From 1.01 to 1.50 = 1 cookie

From 1.51 to 1.99 = 2 cookies

Ex: Serving size for sweet butter cookies = 30 grams

If a cookie’s average weight = 7 grams

30 grams/7 grams = 4.28 cookies rounded off to 4 cookies

If a cookie’s average weight = 8 grams

30 grams/8 grams = 3.75 cookies rounded off to 4 cookies

If a cookie’s average weight = 4 grams

30 grams/4 grams = 7.5 cookies rounded off to 7 cookies

4. DESCRIPTION OF THE NUMBER OF SERVINGS PER CONTAINER

4.1 The label may also contain a description of the number of servings per container.

4.2. When a package’s net weight, in grams, divided by its serving size, in grams, does not yield a whole number, the manufacturer may indicate the fraction or the whole or half closest to the fraction, rounded off according to the following :

From 1.0 to 1.30 = 1

From1.31 to 1.70 = 1 1/2

From 1.71 to 2 = 2

Ex: Serving size for sweet butter cookies = 30 grams

Net weight of package = 180 grams

180 grams/30grams = 6 servings/package

Net weight of package = 200 grams

200 grams/30 grams = 6.6 servings/package or round off to 6 1/2 servings

5. ADDITIONAL INSTRUCTIONS

5.1. When a package consists of a secondary (collective) wrapper containing a group of identical units, each wrapped for individual consumption, servings per package corresponds to the number of individual units contained in the package.

a)when the individual units can be sold separately, each one should contain nutrition facts.

b)when the individual units cannot be sold separately, nutrition facts referring to an internal unit need only appear on the secondary wrapper.

5.2. When secondary (collective) packaging contains internal units wrapped for individual consumption, but whose nutritional values differ, the nutrition facts on the secondary packaging must refer to:

a) the average serving size of individual units, when variability between those units does not exceed 5% in relation to the average net weight of each type, 10% in relation to average macronutrient values, and 20% in relation to average micronutrient values. It must be stated explicitly that the nutritional information tables on these packages refer to an average for the different types of products contained within.

b) each individually wrapped unit within the external package, when variability from the average exceeds those parameters presented in item 5.2 a.

c) in cases where secondary (collective) packaging contains an assortment of products from the same group of each table, the conditions of item 5.2.a do not apply, and serving sizes are calculated in units of reasonable average nutritional values.

5.3. Transparent secondary (collective) packages destined for promotional sale are exempt from obligatory nutritional labeling, providing each internal unit contains the required nutrition facts.

6. FOODS WITH SPECIAL PURPOSES, WITH COMPLEMENTARY NUTRITION FACTS AND WITH ADDED ESSENTIAL NUTRIENTS

6.1 Foods with special purposes, with complementary nutrition facts and with added essential nutrients must observe the specific Technical Regulations along with the standards for general nutritional labeling.

6.2. Manufacturers should recommend serving sizes for specific foods, according to their specific purposes.

7. FOODS WITHOUT A SPECIFIC PURPOSE, BUT DESTINED SPECIFICALLY FOR CHILDREN UNDER 6

7.1 Serving sizes for nutritional labeling of those foods destined specifically for children under 6 will be those recommended by the manufacturer for each specific product, provided they do not exceed the serving size indicated for the over-6 population.

8. FOODS REQUIRING ADDITIONAL PREPARATION

8.1 If a product requires additional preparation (ex: cooking in water or other ingredients, adding milk or sugar, fruit juices, etc.) and the serving size of a prepared serving is not indicated on the serving size for nutritional labeling reference tables, serving size may be determined using the following rules:

a) the serving size of a product in its unprepared form should be the amount of the product necessary to make a serving size of the same product ready for consumption (ex: rice flour and other starches for making gruel);

b) when the unprepared contents of a particular package suggest a single serving (ex: instant macaroni), the serving size for the unprepared product is the entire content of the package itself.

c) when the entire contents of a package are used to prepare a single unit for collective consumption (ex: dry cake mixes), the unprepared product’s serving size consists of the quantity of the product necessary to make a fraction of the larger unit (ex: cake) corresponding to the serving size of the prepared product (ex: grams).

9. FOODS MODIFIED BY THE INCORPORATION OF AIR (AERATED FOODS).

9.1. If a food modified by incorporation of air has its weight density reduced by 25% or more in comparison to the same food in its conventional form (ex: an aerated chocolate bar x a conventional chocolate bar), the manufacturer can determine the aerated product’s serving size adjusting for the difference in density.

With this procedure, servings of the aerated product measured in grams are the same as those of the equivalent conventional product, while servings using household measures are larger.

9.2. The manufacturer may also opt to present the serving size in household measures similar to those of the conventional product, indicating more clearly to the consumer the extent to which the aerated product is reduced in terms of caloric and nutrient density.

9.3. The National Sanitary Surveillance Agency (ANVISA) can request the manufacturer to provide records of the calculations and data utilized to adjust the density of the aerated product.

10. FOODS PRESENTED IN COMBINATIONS NOT INCLUDED IN THE SERVING SIZE FOR NUTRITIONAL LABELING REFERENCE TABLE

10.1. For products consisting of two or more foods packaged in a way that suggests they be consumed together (ex: yogurt and cereal), but which lack defined nutritional labeling serving sizes for either the unprepared or prepared form, the serving size of the combined products will be determined by the following procedure:

a) for individualized packages that suggest the entire contents be consumed at one sitting (ex: yogurt and cereal), the serving size consists of the sum of the two products. The information referring to household measures should represent the sum of the two products using the most appropriate measurement unit (ex: a tablespoon of yogurt and cereal; a container of yogurt and cereal).

b) for collective packages (ex: a cake mix packaged with a frosting mix), the serving size consists of the sum of the quantities of the individually-described fractions of each product, with nutrition facts presented for the combined product.

11. PROCEDURE FOR INCLUSIONS AND ALTERATIONS OF SERVING SIZE

11.1. The Packaged Food and Beverage Serving Size Reference Tables that follow take into consideration all of the types of food produced in Brazil up to the time of the tables' preparation. Serving sizes for any new foods discovered or commercialized which do not fit into the definition of any existing type of food, should be calculated according to the same methodological principles already used.

11.2. Any solicitation for inclusion in or revision of the Table should include justification demonstrating the significant difference in the product’s serving size from those of existing types of food which might be considered the same.

11.3. Manufacturers may direct their requests for inclusion or revision to the National Sanitary Surveillance Agency (ANVISA) at any time.

11.4. It is up to ANVISA to judge the pertinence of requests and open the process of public consultation.

11.5. The implantation of the Packaged Food and Beverage Serving Size for Nutritional Labeling Reference Table should be coordinated by ANVISA, with technical support from the Ministry of Health; representatives from the production sector, the consumer defense community and the scientific community working in the area of food and nutrition.

PACKAGED FOOD SERVING SIZES FOR NUTRITIONAL LABELING

TABLE I – BREAD, CEREALS AND CEREAL PRODUCTS, OTHER GRAINS, ROOTS AND TUBERS

(1 serving = approximately 150 calories)