MINISTRY OF AGRICULTURE, LIVESTOCK AND SUPPLY
MINISTER’S OFFICE
REGULATORY DIRECTIVE (INSTRUÇÃO NORMATIVA) Nº 22, NOVEMBER 24, 2005
THE MINISTER OF AGRICULTURE, LIVESTOCK AND SUPPLY —under the authority of article 87(II) of the Constitution, on the basis of Decree 30691 (1952-03-29) and its amendments regulating Law 1283 (1950-12-18) on the industrial and sanitary inspection of animal products, Law 7889 (1989-11-23) regulating the industrial and sanitary inspection of animal products and other matters, Law 8078 (1990-09-11) regulating consumer protection and other matters, and Files 21000.005172/01-29, 21000.005432/2002-57 (consolidated) and Document 70000.010271/2002-29 (appended)— hereby issues the following Regulatory Directive:
Article 1 – The TECHNICAL REGULATIONS FOR THE LABELING OF PACKAGED ANIMAL PRODUCTS, appended hereto, are hereby approved.
Article 2 – Companies have sixty days from the date of issue of this Regulatory Directive to comply therewith.
Article 3 – This Regulatory Directive shall go into effect on the date of its publication.
Article 4 – Administrative Directive (Portaria) 371 (1997-09-04) is hereby revoked.

ROBERTO RODRIGUES

ANNEX 
TECHNICAL REGULATIONS FOR THE LABELING OF PACKAGED ANIMAL PRODUCTS

1. SCOPE 
These Technical Regulations shall apply to the labeling of all prepackaged animal products ready for offer to the consumer, via interstate and international trade, regardless of their place of origin. 
In cases where the particular characteristics of an animal product call for specific regulations, the latter shall serve as a supplement to these Technical Regulations. 

2. DESCRIPTION 

2.1. DEFINITIONS 
The following definitions shall apply for the application of these Technical Regulations: 

2.1. Label or labeling: any inscription, legend, image or descriptive or graphic matter —whether written, printed, stamped, engraved, embossed, lithographed or glued— applied to the packaging of the animal product. 

2.2. Packaging: a container, package or packaging used to preserve, and facilitate the shipment and handling of, animal products. 

2.2.1. Primary package or wrapper: packaging that is in direct contact with the animal product. 

2.2.2. Secondary package or wrapper: packaging that contains the primary packaging. 

2.2.3. Tertiary package or wrapper: packaging that contains one or more secondary packages. 

2.3. Packaged animal product: any animal product that is packaged and ready for offer to the consumer. 

2.4. Consumer: any natural or legal person who acquires or uses an animal product. 

2.5. Ingredient: any substance, including food additives, used in the manufacture or preparation of an animal product, and present in its original or modified form in the final product. 

2.6. Raw material: any substance that, to be used as food, must undergo physical, chemical or biological treatment and/or processing. 

2.7. Foodstuff: any substance of plant or animal origin, in the raw state, which, to be used as food, must undergo treatment and/or processing of a physical, chemical or biological nature. 

2.8. Food additive: any ingredient, without nutritive value, intentionally added to an animal product during its manufacture, processing, preparation, treatment, packaging, packing, storage, transport or handling, in order to modify its physical, chemical, biological or sensory characteristics. This results directly or indirectly in making the additive itself or its by-products become ingredients of the animal product. This definition does not include contaminants or nutritive substances that are added to the animal product in order to maintain or improve its nutritional qualities. 

2.9. Food: any substance, whether processed, semi-processed or raw, that is intended for human consumption, including beverages, chewing gum and any other substance used in the manufacture, preparation or treatment of food, but does not include cosmetics, tobacco or substances used only as drugs. 

2.10. Raw food: any food of animal or plant origin which requires only the removal of the inedible part for its consumption and the treatments indicated for its proper sanitation and conservation. 

2.11. Enriched food: a food to which a nutritional substance has been added in order to enhance its nutritional value. 

2.12. Animal product: any substance of animal origin —whether processed, semi-processed or raw—, whether or not it is intended for human consumption. 

2.12.1. Edible animal product: a substance of animal origin —whether processed, semi-processed or raw—, intended for human consumption. 

2.12.2. Inedible animal product: a foodstuff of animal origin —whether processed, semi-processed or raw—, whether or not it is intended for animal consumption. 

2.13. Food product or foodstuff: any food derived from a foodstuff or raw food, or from other permitted substances, obtained by appropriate technological processes. 

2.14. Animal product brand name: the specific, non-generic name that indicates the true nature and characteristics of an edible animal product or food. It shall be governed by the Specific Technical Regulation setting forth the identity and quality standards for the product.

2.15. Portioning of the animal product: the operation whereby the animal product is divided and packed for distribution, marketing and delivery to the consumer. 

2.16. Lot: a set of products of the same type, processed by the same manufacturer or packer, in a given period, under essentially the same conditions. 

2.17. Country of origin: the country where the animal product was prepared, or, if it was prepared in more than one country, where it received its last significant processing. 

2.18. Principal display panel: the part of the label where the brand name and trademark or logo, if any, is prominently displayed. 

2.18.1. Front panel: the part of the principal panel most readily visible to the buyer, in customary conditions of display for sale. Metal bottle caps and plastic or laminated film used to seal containers in the form of a bottle or cup are also considered part of the front panel. 

2.18.2. Side panel: the part of the principal panel adjacent to the front panel, where mandatory information is to be set out. 

2.18.3. Secondary panel: the part of the label not usually visible to the consumer when the product is on display for sale. On this part of the label optional or mandatory information is to be set out, at the discretion of the competent authority, along with tags or other written information that forms part of the packaging. 

2.19. Highlight: something that gives emphasis to a warning, phrase or text. When in written form, it must be in uppercase and boldface, in font size as large as the largest lettering used for the informational text, excluding the brand name. When in audio form, it must be clear and audible. 

3. GENERAL PRINCIPLES 

3.1. A packaged animal product must not carry a description or bear a label that: 

a) uses terms, signs, denominations, symbols, emblems, illustrations or other graphic representations that may render the information false, inaccurate or inadequate, or that may mislead or confuse consumers as to its true nature, composition, origin, type, quality, quantity, durability, yield or manner of use; 

b) attributes effects or properties that it does not possess or that cannot be substantiated; 

c) emphasizes the presence or absence of components that are intrinsic or proper to animal products of the same kind, except in the cases provided for in the specific technical regulations; 

d) emphasizes, with respect to certain types of processed animal products, the presence of ingredients that are added to all animal products made with similar technology; 

e) emphasizes qualities that may be misleading as to the real or supposed therapeutic properties that some components or ingredients have or may have when consumed in quantities different from those found in the animal product or when consumed in pharmaceutical form; 

f) states that the animal product has medicinal or therapeutic properties; 

g) recommends its consumption as a tonic to improve health or to prevent or cure disease. 

3.2. The name of a country, region or community, recognized as places where animal products with specific characteristics are made, may not be used in the labeling or advertising of animal products made elsewhere, where this may mislead or confuse consumers. 

3.3. When animal products are made by technological means characteristic of different geographic locations in order to produce animal products with sensory properties similar to those typical of certain recognized areas, the name of the animal product must include the word “type” in lettering of equal size, prominence and visibility as that used for the approved designation in the regulations in effect in the country of consumption. 

3.4. Animal products may be labeled only in processing establishments approved by the competent authority of the country of origin. When the labeling is not in the language of the country of destination, an additional tag must be affixed containing the mandatory information in the appropriate language in lettering of adequate size, prominence and visibility. This tag may be affixed either at the place of origin or at the place of destination. In the latter case, the tag must be affixed prior to marketing. 

4. LANGUAGE

4.1. All the mandatory information must be provided in writing. One of the sides of the package must bear the same label with exactly the same information in the official language of the country of consumption, in lettering of adequate size, prominence and visibility. Text may also be provided in other languages. 

4.2. When the labeling is in more than one language, all mandatory information of equivalent importance must be written in lettering of the same size, prominence and visibility. 

5. MANDATORY INFORMATION 

Unless specified otherwise herein or in specific technical regulations, the labeling of a packaged animal product must display the following information: 

- brand name of the animal product: the animal-product name must be indicated on the principal panel of the label in prominent lettering, of uniform size and color, without intervening designs or other words. The size of the lettering used must be proportional to that used for the trademark or logo, if any; 

- list of ingredients: the list of ingredients must be indicated on the label in descending order of quantity, including the function, name and INS number of any additives; 

- liquid content: liquid content must be indicated on the principal panel of the label in accordance with the Specific Technical Regulations; 

- identification of origin; 

- name or corporate name and address of the establishment; 

- name or corporate name and address of the importer, in the case of imported animal products; 

- official Federal Inspection stamp; 

- Category of the establishment, according to its DIPOA registration; 

- CNPJ number; 

- product conservation; 

- product trademark; 

- lot identification; 

- date of manufacture; 

- period of minimum durability; 

- product composition; 

- “Registro no Ministério da Agricultura SIF/DIPOA sob nº-----/-----” [Ministry of Agriculture SIF/DIPOA registration number___]; and

- where necessary, directions on how to prepare and use the edible animal product or food. 

6. PRESENTATION OF MANDATORY INFORMATION 

6.1. The brand name of the animal product must be indicated on the label in accordance with the Technical Regulations on Product Identity and Quality. 

The name or the name and trademark of the animal product must meet the following requirements: 

a) when one or more designations are specified in Technical Regulations for Identity and Quality, at least one of those designations must be used; 

b) a common name, fancy name, manufacturing name or registered trademark may be used, provided it is accompanied by one of the designations set forth in paragraph (a); and 

c) The name may contain additional words or phrases —to prevent the consumer from being misled with respect to the nature and physical conditions of the animal product—, which must be placed next to or near the name of the animal product. For example: type of cover, presentation format, condition or type of treatment which it has undergone. 

6.2. List of ingredients 

6.2.1. With the exception of animal products consisting of only one ingredient (for example, fresh meat, pasteurized milk, fresh raw fish), the label must contain a list of ingredients; 

6.2.2. The list of ingredients must be set out on the label preceded by the word "ingredientes:" [ingredients] or "ingr.:", as specified below: 

a) all the ingredients must be listed in descending order of proportion; 

b) where an ingredient is an animal product made with two or more ingredients, such a compound ingredient, defined in a specific technical regulation, may be declared as such in the list of ingredients, provided it is immediately accompanied by a list, in brackets, of its ingredients in descending order of proportion; 

c) where a compound name is established in a specific Technical Regulation for an ingredient and it constitutes less than 25% of the animal product, the ingredients, other than food additives that serve a technological function in the finished product, need not be declared; 

d) water must be declared in the list of ingredients, except when the water forms part of an ingredient such as brine, syrup or sauce, and these compound ingredients are declared as such in the list of ingredients. Water or other volatile ingredients evaporated in the course of manufacture need not be declared; 

e) in the case of dehydrated, concentrated, condensed or evaporated animal products, which are intended to be reconstituted by the addition of water for their consumption, the ingredients may be listed in order of proportion (m/m) in the reconstituted animal product. In such cases, the following expression must be included: 
“Ingredients of the product when prepared in accordance with the directions on the label”;

f) in the case of mixtures of fruits, vegetables, spices or herbs, where none of these significantly predominates in proportion by weight, those ingredients may be listed in another order, provided that list of ingredients is accompanied by the expression “in variable proportion”. 

6.2.3. Declaration of Food Additives in List of Ingredients. Food additives must be declared in the list of ingredients. This declaration must state: a) the main function of the additive in the animal product; and b) its complete name or INS number, or both. 

Where there is more than one food additive with the same function, one may be mentioned followed by the other, grouped by function. 

Food additives shall be declared after the ingredients. 

The list of ingredients for some animal products must state the full name of the additive used. This condition must be indicated in the Specific Technical Regulation. 

6.3. Liquid Content. Governed by specific Technical Regulation. 

6.4. Identification of Origin 

6.4.1. The label must indicate: 

- the name (corporate name) of the manufacturer, producer or packer, or of the trademark holder (proprietor); 

- address in full; 

- country of origin and municipality; 

- manufacturing establishment’s registration number or identification code issued by the competent official body. 

6.4.2. One of the following expressions must be used to identify origin: “fabricado em...” [manufactured in ...], "produto...” [produced...] or "indústria...” [...industry]. 

6.5. Lot Identification 

6.5.1. Every label must identify, in code or in clear, in visible, legible and indelible form —whether printed, engraved or marked in some other way— the lot to which the animal product belongs. 

6.5.2. The lot shall be determined in each case by the manufacturer, producer or packer of the animal product or food, according to its criteria. 

6.5.3. The following may be used to indicate the lot: 

a) a code preceded by the letter "L". This code must be available to the competent authority and must be included in the commercial documentation in the case of international trade; or 

b) the date of fabrication, packaging or minimum durability, provided this shows at least the day and month or the month and year (in this order), in accordance with paragraph “b” of subitem 6.6.l. 

6.6. Minimum durability period

6.6.1. Unless provided otherwise by a specific Technical Regulation, the following information must be shown for the minimum durability period: 

a) the “date of minimum durability” must be declared; 

b) the date of minimum durability must contain at least: 

- the day and the month, for products that have a minimum durability not more than three months; 

- the month and the year, for products that have a minimum durability more than three months. If the month is December, it is sufficient to indicate the year, with the expression "end of ......" (year); 

c) the date of minimum durability must be declared by means of one of the following expressions: 

- "consumir antes de...” [best  before...]; 

- "válido até...” [valid until...]; 

- "validade..." [validity...] ; 

- "val:..." [validity...]; 

- "vence..." [expires...]; 

- "vencimento..." [expiry...];

– “vto:...” [expiry...]; or

– “venc:...” [expiry...].

d) the expressions set forth in item “c” must be accompanied by: 

- minimum durability period; or 

- a clear indication of the place where the minimum durability period is contained; or 

- the day and month or month and year must be imprinted by means of perforations or indelible marks, in accordance with the criteria specified in paragraph “b” of subitem 6.6.1. 

All information must be clear and accurate. 

e) the day, month and year must be stated in uncoded numerical sequence, except that the month may be indicated by letters where such use will not be confusing to the consumer. In this case, the name of the month may be abbreviated to its first three letters; 

6.6.2. The labels on packages of animal products that must be stored under special conditions must contain clear directions for preserving their normal characteristics. They must indicate the maximum and minimum temperatures for storage of the animal product and the time that the manufacturer, producer or packer guarantees its durability under such conditions. This provision also applies to animal products that may be altered after their packaging is opened. 

This characteristic must be indicated especially in the case of frozen animal products whose minimum durability period varies according to the storage temperature. In such cases, the minimum durability period may be indicated for each temperature, according to the aforementioned criteria, or else the minimum durability period for each temperature, indicating the day, month and year of fabrication. 

The following expressions may be used to indicate the minimum durability period: 

"minimum durability at -18ºC (deep freezer): ..." ; 

"minimum durability at - 4ºC (freezer): ..." ; or

"minimum durability at 4ºC (refrigerator): ..." . 

6.7. Product preparation and directions for use 

6.7.1. When necessary, the label must contain directions on the proper use of the product, including reconstitution, thawing or treatment by the consumer. 

6.7.2. To ensure proper use of the animal product, such directions must not be unclear or open to misinterpretation. 

7. OPTIONAL LABELING 

7.1. The label may contain any information or graphic representation, along with written, printed or engraved matter, provided this does not conflict with the mandatory requirements of these Regulations, including those relating to the statement of properties and misleading information, set forth in item 3 of the General Principles. 

7.2. Designation of Quality 

7.2.1. Designations of quality may be used only when specifications have been established for a particular animal product by means of a specific Technical Regulation. 

7.2.2. Such designations must be easily understandable, must not be misleading to consumers in any way and must comply with all the criteria for identifying the quality of the animal product. 

7.3. Nutritional Information. Nutritional information may be provided, as long as this is not in conflict with item 3 of the General Principles. 

8. PRESENTATION AND DISTRIBUTION OF MANDATORY INFORMATION 

8.1. The principal panel must indicate the brand name of the animal product, its quality, purity or mixture, when regulated, [and] the nominal quantity of product. This information, together with any design, must be displayed prominently, in contracting colors, to ensure its visibility. 

8.2. The lettering and numbers on the mandatory label, except for the brand name of the animal product and the indication of liquid content, must not be less than 1 mm in size. 

9. SPECIAL CASES 

Small units, i.e. those with a label whose principal display panel has an area of less than 10 cm2, may be exempted from the requirements set forth in item 5 of Mandatory Information, but must indicate at least the product’s brand name and trademark. 

In the cases specified in item 9.1, packaging that contains small units must provide all the mandatory information required. 

When vegetable fat is added to the animal product during processing, the principal panel of the label must bear the legend CONTAINS VEGETABLE FAT, immediately below the name of the product, in uppercase boldface letters of uniform size and color, with no intervening words or designs. 

Labeling on packages containing animal products not intended for human consumption must bear, in addition to the Federal Inspection stamp, the inscription “inedible,” branded or engraved in prominent lettering. 

The labeling on packaging containing animal products intended for animal feed shall contain, in addition to the Federal Inspection stamp, the declaration “food for animals.” 

The labeling on packages containing transgenic or organic animal products must comply with the requirements of the Specific Technical Regulation.