Required Report - public distribution

**Date:** 7/12/2006

**GAIN Report Number:** BR6011

BR6011

**Brazil**

**Food and Agricultural Import Regulations and Standards**

**Country Report**

**2006**

**Approved by:**

![](media/image1.wmf)Morgan Perkins, Director

US AGRICULTURAL TRADE OFFICER

**Prepared by:**

Fabiana Fonseca, Agricultural Marketing Specialist

**Report Highlights:**

This report outlines regulatory requirements for agricultural imports
into Brazil, including import procedures. Significant changes have been
introduced in Sections I, II, VII and VIII of this report to reflect
changes implemented by the Brazilian Government during the past year.

Includes PSD Changes: No

Includes Trade Matrix: No

Annual Report

Sao Paulo \[BR3\]

\[BR\]

I. Food Laws

II.Labeling Requirements

III.Packaging and Container Requirements

IV.Food Aditive Regulations

V.Pesticide and Other Contaminants

VI\. Other Regulations and Requirements

VII\. Other Specific Standards

VIII.Copyright and/or Trademark Laws

IX.Import Procedures

APPENDIX I.Government Regulatory Agency Contacts

APPENDIX II. Other Import Specialist contacts

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# 

# DISCLAIMER: the US Agricultural Trade Office (ATO) of the USDA/Foreign Agricultural Service in Sao Paulo, Brazil has prepared this report for US exporters of domestic food and agricultural products. While every possible care has been taken in the preparation of this report, information provided may not be completely accurate either because policies have changed since its preparation, or because clear and consistent information about these policies was not available. It is highly recommended that US exporters verify the full set of import requirements with their foreign customers, who are normally best equipped to research such matters with local authorities, before any goods are shipped. FINAL IMPORT APPROVAL OF ANY PRODUCT IS SUBJECT TO THE IMPORTING COUNTRY'S RULES AND REGULATIONS AS INTERPRETED BY BORDER OFFICIALS AT THE TIME OF PRODUCT ENTRY. Please contact this office, if you have any comments, corrections or suggestions about the material contained in this report. Our telephone, fax, and e-mail address are provided at the end of this report.

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### 

### I. FOOD LAWS

Brazil is a member of the World Trade Organization (WTO) and therefore
has made commitments to subscribe to the Sanitary and Phytosanitary
(SPS) Agreement, and to Codex Alimentarius (CODEX) principles. Food
regulations issued at the federal level are contained in various types
of legal documents and in order to be implemented, must be published in
Brazil's Diario Oficial (similar to the US Federal Register).

Brazil has three levels of government: federal, state and municipal.
Legally, federal regulations must be followed when there are conflicts
between federal-state-municipal legislation, or between regulations
established by different Ministries at the federal level. State and
municipal governments also have the authority to regulate and enforce
state and municipal laws.

In the federal government numerous agencies under several Ministries
share jurisdiction for ensuring the safety of the Brazilian food supply
and regulating imports of agricultural commodities and foods. The
Ministry of Agriculture, Livestock, and Food Supply (MAPA) oversees and
enforces a large portion of regulations pertaining to production,
marketing, import and export of animal origin products, fresh fruit and
vegetables, alcoholic beverages, juices, grains, seeds, animal feed
(including pet food). The Ministry of Health (MS) enforces most of the
regulations regarding processed food products.

Other Ministries and/or agencies also involved in monitoring/control of
food safety include the Environment Protection Institute (IBAMA), of the
Ministry of the Environment; The National Institute of Metrology,
Standardization and Industrial Quality (INMETRO), of the Ministry of
Development, Industry and Commerce (MDIC); the National Technical
Commission on Biosafety (CNTBio), which is an inter-Ministerial
Commission based in the Ministry of Science and Technology (MCT); and
the Department of Consumer Protection and Defense (DPDC) within the
Ministry of Justice.

### 

### I.I. Legal Framework

**Constitution**

The fundamental organic law, written, that structures and organizes the
State, establishing the limits and attributions

of the various departments that comprise the Public Power and the
exercise of the political and civil rights

**Constitutional Amendment**

Revision in the Constitution, carried out as established by the
political Charter itself.

**Ordinary Law - Law**

Ordinary Law: Act that emanates from Congress, the federal Legislative
Power;

Law: mandatory norm, general, abstract and in force, emanated from the
competent power (e.g. a state), which all are required to obey, under
penalty or sanction; the solemn expression of the will of the State's
supreme power.

**Provisional Executive Act**

Act with the force of law - is not voted - but is issued by the
President of the Republic, to dispose of matter of

relevant and urgent nature, to be submitted to the National Congress for
conversion into law.

**Decree**

Regulates the law, says how it should be applied

**Regulation Act Declaratory Provision**

In theory, it explains operational procedures. Sometimes it modifies
parts of a Decree;

in this case it is possible to question the legality of the Regulation
Act and/or the Declaratory Provision.

> **Normative Rule Administrative Rule Resolution**
>
> The outcome of the A broadly applicable agency A formal expression of
>
> Executive decision on statement that interprets a an opinion,
> intention, or
>
> some point of a Regulation Act or decision by an official
>
> Regulation Act or Declaratory Provision body.
>
> Declaratory Provision on describing the agency's
>
> a case as a whole. requirements.

Please note that Brazilian legislation may be found on the internet. The
following terms were translated above: Law (Lei), Constitutional
Ammendment (Emenda Constitucional), Provisional Executive Act (Medida
Provisoria), Decree (Decreto), Regulation Act (Instrucao Normativa),
Declaratory Provision (Ato Declaratorio), Normative Rule (Parecer
Normativo), Administrative Rule (Portaria) and Resolution (Resolucao).

**I.2. Ministry of Agriculture, Livestock and Food Supply (MAPA)**

Decree n° 5351, dated January 21, 2005 changed the structure of the
Brazilian Ministry of Agriculture, Livestock, and Food Supply (MAPA).
The Ministry is now composed of five major offices, called Secretariats:
the Secretariat of Agricultural Policy (SPA), the Secretariat of Rural
Development and Cooperatives (SARC), the Secretariat of Production and
Agro Energy (SPA), the Secretariat of Agricultural Protection (SDA), and
the Secretariat of International Agribusiness Relations (SRI). MAPA's
regulatory activities of interest for this report are primarily enforced
by SDA and SRI.

Responsible for enforcing regulations governing domestic and imported
plants and animals, and their respective products and by-products, and
other products and inputs, such as feed, fertilizers, pesticides, and
veterinary products. SDA is composed of six main departments and one
major office that oversees inspection at airports and ports, called
General Coordination for International Sanitary Inspection of
Agriculture and Livestock (CGVIG).

DIPOA is responsible for ensuring that all products of \"animal origin\"
(meat derived from cattle, sheep, swine, goats, horses, game meat,
poultry, dairy products, eggs, and seafood) moving in interstate and
foreign commerce are safe, wholesome for consumption, and accurately
labeled. DIPOA's regulatory responsibilities might be exercised in the
U.S. by:

-   USDA's Food Safety Inspection Service (FSIS)

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-   USDA's Agricultural Marketing Service (AMS)

-   US Department of Health and Human Services' (HHS)

-   Food and Drug Administration (FDA)

-   US Department of Commerce's (USDOC)

-   National Oceanic and Atmospheric Administration

-   National Marine Fisheries Services (NOAA/NMFS) for seafood products.

> DIPOV has the regulatory authority to enforce federal laws regarding
> the registration, compliance and labeling of beverages (including
> distilled spirits, wine, soft drinks, and juices). In this respect
> it's regulatory responsibilities might be exercised in the U.S. by:

-   Department of Treasury's Bureau of Alcohol, Tobacco and Firearms
    (ATF)

> Note: DIPOV provides a broader spectrum of services than ATF,
> including laboratory tests. To clear customs, these products are
> subject to inspection by DIPOV, who will hold samples for chemical
> analysis
>
> DSA is responsible for enforcing regulations governing the import and
> the export of live animals, semen and embryos. In cooperation with
> State governments, DSA enforces federal laws and regulations to
> protect and improve animal health, control and eradicate animal
> diseases (such as the Foot-and-Mouth Disease Eradication Program). It
> defends Brazilian borders against foreign and exotic animal diseases.
> In this respect, DSA's regulatory responsibilities might be exercised
> in the U.S. by:

-   Animal and Plant Health Inspection Service's (APHIS) Veterinary
    Services (VS)

> Note: to export live animals, semen and embryos to Brazil, exporters
> of US genetics must meet the animal health requirements issued by DSA,
> which can be seen on APHIS/VS's home page
> <http://www.aphis.usda.gov/>. Several of these requirements were
> updated recently to include restrictions on imports of animal genetics
> and animal by-products in view of the BSE cases in the US.

DSV is responsible for protecting the health of plants, and preventing
the introduction and spread of foreign pests within Brazil. DSV's
regulatory responsibilities might be exercised in the U.S. by:

-   APHIS's Plant Protection and Quarantine (PPQ)

> Note: all unprocessed products of plant origin (bulk grains, fresh
> fruits and vegetables, nuts, and seeds can only be exported to Brazil
> if accompanied by a APHIS/PPQ phytosanitary certificate. US exporters
> should always check with the nearest PPQ office or the APHIS /PPQ home
> page <http://www.aphis.usda.gov/> to see the latest import
> requirements from Brazil for unprocessed plant products because
> Brazil's regulations in this area are changing frequently due to the
> gradual harmonization of plant health regulations within MERCOSUL.

DFIA is responsible for the regulatory inspection and registration of
all planting seeds and seedling (including biotech seeds), as well as
for establishing standards for agricultural products such as grains,
fruits and vegetables. Its regulatory responsibilities might be
exercised in the U.S. by:

-   APHIS/PPQ

-   AMS

-   Grain Inspection, Packers, and Stockyards Administration (GIPSA)

Note: DFIA also has the authority to enforce federal laws regarding the
registration, compliance and labeling of fertilizers and pesticides,
similar to those functions of the EPA in the United States.

> DFIP is responsible for the regulatory inspection of feed for animal
> consumption (including pet food), the registration of establishments
> producing animal semen and embryos, and the genealogical registration
> of live animals. DFIP also regulates the use of veterinary products.
> Its regulatory responsibilities might be exercised in the U.S. by:

-   APHIS/VS

-   GIPSA

-   Food and Drug Administration (FDA)

> Note: US companies exporting feed and fodder, pet food, live animals,
> semen and embryos must obtain an import permit from DFIP. Brazilian
> importers of live animals must obtain a permit for import that meets
> the Brazilian genetic requirements for a specific breed. Brazilian
> importers of pet food must register the imported products with DFIP
> before applying for an import permit. In all cases, the Brazilian
> importer must be registered with MAPA.

The major laws and regulations that provide SDA and its departments with
regulatory authority for domestic and imported products of animal and
plant origin include: Decree n° 30691 of March 29, 1952; Regulation Act
n° 574 of December 8, 1998; Regulation Act n° 183 of October 9, 1998;
Resolution n°1 of January 21, 1999; Regulation Act n° 46 of February 10,
1998; Decree n° 24548 of July 3, 1934; Decree n° 64499 of May 14, 1969;
Decree n° 239 of December 30, 1998; Decree n° 24144 of April 12, 1934;
Administrative Rule n° 641, n° 642 and n° 643 of October 3, 1995;
Administrative Rule n° 186 of March 21, 1996; Administrative Rule n° 130
of April 15, 1997; Administrative Rule n° 158 of April 16, 1997;
Administrative Rule n° 182 of November 9, 1998 and Decree n° 5351 of
January 1, 2005.

As a new office within MAPA, SRI is responsible for coordinating
Brazilian government agricultural positions in international forums,
such as the World Trade Organization (WTO), Office of International
Epizootics (OIE), International Plant Protection Committee (IPPC), and
Codex Alimentarius (CODEX). SRI also coordinates all regional and
bilateral agricultural agreements and coordinates with other Ministries
for the promotion of agricultural and food products. SRI is also the new
focal point for negotiations between the United States and Brazil in the
area of agriculture under the Consultative Committee on Agriculture
(CCA).

SRI is composed by three main departments, two of them impact trade
between US exports.

> DAC is responsible for bilateral, multilateral or regional
> negotiations involving agriculture and livestock.
>
> DASF supports all government commitments on international negotiations
> regarding sanitary and phytosanitary issues.

**I.3. Ministry of Health (MS)**

The Ministry of Health's (MS) regulatory activities are enforced by an
agency called the National Agency of Sanitary Surveillance (ANVISA).
ANVISA is a semi-autonomous agency within the Ministry of Health. ANVISA
was officially created by Law n° 9782 on January 26, 1999, and
implemented by Decree n° 3029 of April 19, 1999, as the scientific
regulatory agency responsible for the safety of all foods under its
authority (mainly processed products). The agency is also responsible
for overseeing the production and registration of drugs, food additives,
medical devices, and tobacco and tobacco products. Furthermore, ANVISA
coordinates the System of Administrative, Technical and Sanitary
Management at Ports, Airports, and Borders (SISPAF) at the national
level.

The primary function of ANVISA is to protect the public (i.e., human
health) by assessing food standards, safety, and contaminants. In
addition, the agency is responsible for the registration of any food
processing facility established in the country. Prior to launching any
new product, the company must apply for a registration number, which
must be placed on the label of the product - for food products the
registration number is valid for 5 years, while the registration of
foreign or domestic firms must be renewed on a yearly basis. According
to Law n° 9782 (cited above), all foreign food goods must follow the
same registration procedures as those required for locally manufactured
food items.

On March 16, 2000, ANVISA published Resolutions n° 22 and n° 23 in the
Diario Oficial (Brazil's Federal Register), establishing the procedures
for registration and exemption of registration for imported food
products that fall under the regulatory authority of the Ministry of
Health. These Resolutions were updated by Resolution n° 278 of September
22, 2005. The objectives of these 3 Resolutions are to provide guidance
to food importers and to improve ANVISA's efficiency in coordinating
public health actions on imported food products. The products listed
under ANNEX I (see below) are those food products which are exempt from
product registration, while ANNEX II lists those products which have a
mandatory registration requirement with ANVISA.

The request for registration or exemption of registration must be made
by the legal representative of the exporting company, a local
subsidiary, or by the food importer. If there is more than one importer
for the same product, each importer must make a separate request. All
imported products, additives and packaging must be in accordance with
Decree-Law 986, of October 21, 1969 and respective regulations.

Importers of food products that are exempt from registration are still
required to complete a form (ANNEX III) requesting that the product be
exempt from registration. These forms must be delivered to the local
office of the Ministry of Health in the state where the importer is
legally based. Importers of food products under ANNEX II must register
their products and pay fees, which vary according to the size of the
company. The following fee structure is currently in force:

+----------------+---------+---------+---------+---------+---------+
| DESCRIPTION    | FEE BY  |         |         |         |         |
|                | COMPANY |         |         |         |         |
|                | SIZE\*  |         |         |         |         |
+----------------+---------+---------+---------+---------+---------+
|                | Group   | Group   | Group   | Group   | Group   |
|                | I\*\*   | II\*\*  | III\*\* | IV\*\*  | V\*\*   |
|                |         |         |         |         |         |
|                | Large   | ######  | Medium  | Medium  | Small   |
|                |         | # Large |         |         |         |
+----------------+---------+---------+---------+---------+---------+
| Company        | #       | R       | R       | R       | R\$600  |
| Registration   | ##### R | \$5,100 | \$4,200 | \$2,400 |         |
| (Authorization | \$6,000 |         |         |         |         |
| to Sell)       |         |         |         |         |         |
+----------------+---------+---------+---------+---------+---------+
| Product        | R       | R       | R       | R       | R\$600  |
| Registration   | \$6,000 | \$5,100 | \$4,200 | \$2,400 |         |
+----------------+---------+---------+---------+---------+---------+

Note:

\*Fees are charged in local currency: the \"Real\" (R\$). Average
exchange rate in June 2006 US\$ 1.00=R\$2.20

\*\*For the purposes of this regulation the size of the company is
defined as follows: Group I (Annual Income above R\$50 million); Group
II (Annual Income between R\$20 million and R\$50 million); Group III
(Annual income between R\$6 million and R\$20 million); Group IV (Annual
income between R\$2 million to R\$6 million), and Group V (Annual Income
below R\$2 million). These criteria are based on Provisional Executive
Act n° 2190-34, dated August 23, 2001. Brazil also defines some
companies as "micro" companies, with annual income below R\$434,000. In
this case, companies are exempt from the above fees.

ANNEX I: Imported food products and packages [exempt]{.underline} from
registration under RDC/ANVISA n° 278/05

  -------------- --------------------------------------------------------
  CODE           PRODUCT DESCRIPTION

  4100115        Sugar and sweeteners

  4100191        Flavoring additives

  4200039        Foods with added essential nutrients

  4200038        Foods and beverages with complementary nutritional
                 information

  4300167        Confectionery products

  4100018        Coffee, barley, tea, erva-mate and instant products

  4100166        Chocolates and cocoa products

  4200071        Packaging

  4300194        Enzyme and enzyme preparations

  4100042        Seasonings, condiments and sauces

  4200012        Frozen products and preparations for frozen products

  4200123        Ice

  4200098        Mixes for food preparation and ready for consumption
                 products

  4100158        Vegetable oils, fats and vegetable cream

  4300151        Cereals and derivatives

  4300196        Products containing protein of vegetable origin

  4100077        Vegetable products (excl. cabbage), fruit products and
                 mushrooms
  -------------- --------------------------------------------------------

ANNEX II: Imported food products and packages with mandatory
registration under RDC/ANVISA n° 278/05

  -------------- --------------------------------------------------------
  CODE           PRODUCT DESCRIPTION

  4200047        Additives

  4100114        Dietetic sweeteners

  4300164        Waters containing salt

  4200020        Mineral water and natural water

  4300032        Functional foods or health restrictions

  4300033        Infant food

  4300083        Food for weight control

  4300078        Food with dietary restrictions of nutrients

  4300086        Foods for diets with controlled sweeteners

  4200081        Foods for special diets

  4300088        Foods for pregnant and lactating women

  4300087        Foods for elderly people

  4300085        Foods for sport participants

  4200055        Technology coadjutants

  4300031        Packaging from new technologies (recycled)

  4300030        New foods and/or new food ingredients

  4100204        Salt

  4200101        Other salts

  4300090        Bioactive substances and probiotic isolates claiming
                 functional and/or healthy attributes

  4300041        Vitamin and/or mineral supplements

  4000009        Canned vegetable (cabbage)
  -------------- --------------------------------------------------------

Note: the codes used before each product in the ANNEXES below are
control codes used by the Ministry of Health, and should not be confused
with the codes of the Harmonized Tariff System (HS).

ANNEX III: Form

+---------+------------------------------------------------------------+
| Field A | To be filled in by the Sanitary Authority                  |
+---------+------------------------------------------------------------+
| Field B | Name of the Importer, Legal Representative of the Exporter |
|         | or Subsidiary. Full address, Phone, Fax, E-mail, and       |
|         | Corporate Tax Number.                                      |
+---------+------------------------------------------------------------+
| Field C | Information regarding the warehousing unit.                |
+---------+------------------------------------------------------------+
| Field D | Terms of Responsibility to be signed by the importer.      |
+---------+------------------------------------------------------------+
| Field E | Product information:                                       |
|         |                                                            |
|         | -   expiration                                             |
|         |                                                            |
|         | -   date of production (Year/Month/Day)                    |
|         |                                                            |
|         | -   code and description of the Product (as per Annex I),  |
|         |                                                            |
|         | -   brand                                                  |
|         |                                                            |
|         | -   type of packaging,                                     |
|         |                                                            |
|         | -   Manufacturer/exporter                                  |
|         |                                                            |
|         | -   country of origin,                                     |
|         |                                                            |
|         | -   commercial perspective (if the product is to be sold   |
|         |     in one specific city, state, or national territory)    |
+---------+------------------------------------------------------------+

Note: It is common practice in Brazil to retain the services of
specialized firms for registration of products with the Ministry of
Agriculture and Ministry of Health.

The major laws and regulations that provide ANVISA's regulatory
authority for domestic and imported processed food products, including
authorization for sale and registration of food products and risk
analysis include: Decree n° 986 of October 21, 1969; Law n° 9782 of
January 26, 1999; Decree n° 3029 of April 19, 1999; Provisional
Executive Act n° 1912-5 of June 30, 1999; Resolution n° 237 of July 2,
1999; Resolution n° 22 of March 16, 2000; Resolution n° 23 of March 16,
2000; Resolution n° 278 of September 22, 2005, Resolution n° 17 of April
30, 1999; Resolution n° 16 of April 30, 1999 and Resolution n° 236 of
December 26, 2001. Brazilian federal regulations related to ANVISA can
be found at <http://www.anvisa.gov.br/>or at the Brazilian Federal
Register web page <http://www.in.gov.br/>.

**I.4. Ministry of Environment (MMA)**

Within the Ministry of the Environment (MMA) the regulatory authority
for activities that affect the environment is called Brazilian Institute
for the Environment and Natural Resources (IBAMA). IBAMA is one of the
key government agencies on approval of agricultural chemicals
(pesticides, herbicides, but has joint authority for this function with
the Ministry of Health (which is concerned with the toxicology aspects
of agricultural chemicals), and the Ministry of Agriculture, Livestock,
and Food Supply (which actually provides the registration for
pesticides).

IBAMA is concerned with the possible environmental impact of pesticides.
In general it follows recommendations made by international standard
setting organizations, such as the CODEX Alimentarius, and works closely
with its US counterpart, the US Environmental Protection Agency (EPA).

IBAMA is also the Brazilian regulatory agency that enforces the treaties
established at the Convention on International Trade in Endangered
Species of Wild Fauna and Flora (CITIES). It is the agency responsible
for monitoring and enforcing activities related to Brazilian fauna and
flora. There are two regulatory rules related to these subjects in
Brazil: the Normative Instruction 3, dated May 27, 2003 which regulates
and lists all Brazilian endangered animal species, and, the Directive
Number 37-N, dated April 3, 1992, which regulates and lists all
endangered plant species (the lists can be found at
<http://www.ibama.gov.br/> or
<http://www.mma.gov.br/port/sbf/fauna/index.cfm>).

**I.5. Ministry of Development, Industry and Foreign Trade (MDIC)**

A. Secretariat of Foreign Trade (SECEX)

All food products imported or exported by Brazil must be registered at
the Secretariat of Foreign Trade (SECEX) of the Ministry of Development,
Industry, and Foreign Trade (MDIC). This office monitors all import and
exports tariffs and issues import and export licenses. In addition,
SECEX is the government agency responsible for judging antidumping cases
against foreign products.

Since January 1997, SECEX, the Secretariat of Federal Revenue (SRF), of
the Ministry of Finance (MF), and the Brazilian Central Bank (BCB) have
been responsible for import related activities such as licensing,
customs clearance and exchange monitoring though the Integrated Foreign
Trade System (SISCOMEX), an administrative software program with graphic
interface for completing computerized-based import documentation
requirements. Since this system has been implemented, import and export
procedures have become more transparent. The system enables the
government to better control tax payments.

Only Brazilian or multinational companies registered with the Importers
and Exporters Registry Office of SECEX are allowed to import.
Registrations completed prior to 1997 have been entered into the
SISCOMEX. New registrants are automatically added to the system upon the
first import transaction. It is necessary to be registered at the SRF in
order to obtain a user password to access the SISCOMEX.

B. National Institute of Metrology, Standardization, and Industrial
Quality (INMETRO)

Also under the MDIC is the National Institute of Metrology,
Standardization, and Industrial Quality (INMETRO), which is the
Brazilian agency or "inquiry point" to handle comments regarding
notifications on Trade Barriers to the World Trade Organization
(WTO/TBT).

INMETRO also conducts tests of domestic and imported products
(industrial or food products) to check that they meet the specifications
of their labels, and the safety of packaging materials.

Note: information on INMETRO can be found at their home page
<http://www.inmetro.gov.br/> and other MDIC legislation and procedures
can be found at <http://www.mdic.gov.br/> or at the Diario Oficial
(Brazil's Federal Register): <http://www.in.gov.br/>.

**I.VI. Ministry of Justice (MJ)**

The Department of Consumer Protection and Defense (DPDC), within the
Ministry of Justice, is the federal agency responsible for enforcing the
Brazilian Consumer Code (CDC) published as Law n° 8078 in 1990
([www.mj.gov.br/DPDC/servicos/legislacao.htm](../www.mj.gov.br/DPDC/servicos/legislacao.htm))
The code regulates consumer claims against adulterated food products,
incorrect or misleading labels, and fraud. Each state in Brazil has an
office of the Department of Consumer Protection and Defense that assists
consumers directly in pursuing their rights. The major regulations that
provide the Ministry of Justice regulatory authority over domestic and
imported food products, mostly in the area of food labeling and consumer
rights are: Law n° 8078 of September 11, 1990; Decree n° 3871 of July
18, 2001 and Decree n° 4680 of April 24, 2003.

For additional information on the Ministry of Justice's consumer
department please check the Ministry of Justice's home page
www.mj.gov.br. Other Brazilian federal regulations regarding the
Ministry of Justice can be found in the home page of the Diario Oficial
(Brazil's Federal Register): <http://www.in.gov.br/>.

### II. LABELING REQUIREMENTS

The Brazilian Consumer Protection Law n° 8078 of September 11, 1990,
requires that all domestic and imported foods and beverages must provide
the consumer with correct, precise, clear and easily readable
information about the product in Portuguese. According to the Consumer
Protection Law, the Brazilian importer is held liable in case of health
risk to the consumer of an imported product. The expiration date,
validity, or shelf life date is very important for Brazilian consumers,
and should never be overlooked. The information required on food
products will follow the ruling of the respective regulating agency.

######### Products under ANVISA follows Resolution n° 259 of September 20, 2002

######### Products under MAPA follows Regulation Act n° 22 of November 24, 2005

MAPA requires that in addition to the registration of the foreign
processing plant, the Brazilian importer must also file a request for
the pre-registration of the foreign labels of processed meat, dairy, and
seafood products. Only those products that have their labels
pre-approved by DIPOA are allowed to enter Brazil. For additional
information, US exporters should contact the Office of Agricultural
Affairs (OAA) in Brasilia.

### II.1. Nutritional Labeling

On December 23, 2003, the Brazilian Ministry of Health's ANVISA
published Resolutions n° 359 and n° 360, establishing new nutritional
labeling requirements for all packaged foods and beverages, including
products under MAPA's responsibility. These nutritional labeling
requirements are similar to those in force in the US. Brazilian
companies must comply with this new regulation beginning July 31, 2006;
these rules also apply to imported packaged foods and beverages.

**III. ADDITIVE REGULATIONS**

In general, ANVISA's requirements are often similar to FDA regulations
for food additives. For a complete list of approved food and coloring
additives US exporters should contact ANVISA directly or a consulting
firm in Brazil which specializes in this area. Brazilian legislation
divides food products into categories and sub-categories. For each
category, allowed additives are listed. The major regulatory framework
for domestic and imported additives is: Decree n° 55871 of March 26,
1965; Resolution n° 386 of August 5, 1999; Resolution n° 234 of August
19, 2002.

The major laws and regulations that provide the regulatory framework for
domestic and imported food adititives are: Provisional Executive Act n°
69 of September 2002, Law n° 9974 of June 6, 2000; Decree n° 4074 of
January 4, 2002; Decree n° 50040 of January 24, 1961, Resolution n° 234
of August 19, 2002 and Resolution n° 169 of June 10, 2002. Brazilian
federal regulations related to the Ministry of Health's Anvisa ANVISA
can be found in their home page at <http://www.anvisa.gov.br/> or at
Diario Oficial (Brazil's Federal Register): <http://www.in.gov.br/>. For
additional guidance, please contact ATO Sao Paulo.

### IV. PACKAGING AND CONTAINER REQUIREMENTS 

The Brazilian Association of Technical Norms (ABNT) is the only
normative forum in Brazil responsible for elaboration of technical rules
(standards and specifications) for the packaging and container
industries. ABNT is also a founding member of the International
Organization for Standardization (ISO), the Mercosul Standardization
Association (AMN), and the Pan American Commission for Technical Ruling
(COPANT).

ABNT conducts the certification for consumer packaging (paper and carton
boxes, plastic bags, steel sheet, aluminum cans, tetrapak, PET bottles,
etc). ABNT also regulates the recycling of packaging and containers for
food products. All manufacturers or importers shall be responsible for
the recycling, disposal and removal of packages or containers that are
likely to cause serious pollution to the environment after consumption
or use. ABNT follows the international Resin Identification Code
(numbering from 1 to 7) of the Society of Plastics Industry) and the
Standard Recycling Symbol.

For detailed regulatory information about packaging and containers, and
links to the main associations of packaging and containers, access ABNT
home page at: <http://www.abnt.org.br/>.

The government's regulatory agency involved with the quality and safety
of packaging and containers for handling food is the National Institute
of Metrology, Standardization, and Industrial Quality (INMETRO), linked
to the Ministry of Development, Industry, and Foreign Trade (MDIC). For
additional information access INMETRO's home page at:
<http://www.inmetro.gov.br/>.

The government regulatory agency involved with the toxicological aspects
of packaging and containers for handling food is the National Agency of
Sanitary Surveillance (ANVISA), under the Ministry of Health (MS). For
additional information access ANVISA's home page at:
<http://www.anvisa.gov/>.

### V. PESTICIDES AND CONTAMINANTS 

In general, Brazil follows the international standards (Codex
Alimentarius) for tolerances for pesticides, herbicides, and fungicides
used in fumigation of agricultural products. These tolerance levels
apply to all chemically treated products, produced in Brazil or
imported, intended for human or animal consumption.

Regulatory authority for the registration of agricultural chemicals in
Brazil is held by a three party committee (Agriculture, Health, and
Environment) of the federal government. The Ministry of Agriculture,
Livestock and Food Supply (MAPA) is the initial contact point for the
petition for registration. MAPA will then forward the petition to the
Ministry of the Environment that will assess the possible environmental
impact of that specific chemical. The petition is then sent to the
Ministry of Health that to assess the toxicology aspects of the product.
Finally, the petition is returned to the MAPA for final approval and
registration. US exporters can obtain a list of approved pesticides by
writing to DFIP.

The major laws and regulations that provide the regulatory framework for
domestic and imported pesticides and other contaminants include
Resolution n° 175 of July 8, 2003; Resolution n° 274 of October 15,
2002; Decree n° 4074 of January 4, 2002; Law n° 9974 of June 2000;
Directive n° 685 of August 27, 1998 and Law n° 7802 of July 11, 1989.

### VI. OTHER REGULATIONS AND REQUIREMENTS 

A. Inspection Requirements for Meat, Dairy, and Seafood Products

Brazilian regulations require US companies exporting products of animal
origin to Brazil to have their products (beef, pork, powdered milk,
whey, lactose, cheese, and seafood) processed in plants in the United
States that are federally inspected. Brazilian inspection officials will
not register US plants on the basis of state inspection or admit
products from uninspected facilities.

The only US federal agencies approved by the Brazilian Government to
certify US processing plants are: the Food Safety and Inspection Service
(FSIS/USDA) for meat and poultry, the Agricultural Marketing Services
(AMS/USDA) or the Food and Drug Administration (FDA) for dairy. The US
dairy product exporter must have the processing plant included in AMS's
list of US Dairy Plants Surveyed and Approved by the USDA Grading
Service or have the Central File Number under FDA. The same procedure
applies for exports of US seafood. The US plant must be inspected by
either NOAA/NMFS or FDA before exporting to Brazil, and be included on
DIPOA's list. The request for registration of the US plant with DIPOA
must be made through the FAS office in the US Embassy in Brasilia. The
US exporter must provide the FAS office in Brasilia, by fax, the
following information:

\(1\) Full name and address of the plant(s), including telephone, fax,
and contact person;

\(2\) Plant registration number with the Food Safety Inspection Service
(FSIS/USDA) for meat products (beef and pork only). The plant
registration number with the Agricultural Marketing Service (AMS/USDA)
or the central file number from the Food and Drug Administration (FDA)
for dairy products. And, the central file number from FDA or Plant
registration number with NOAA/NMFS for seafood products;

\(3\) Description of the product to be exported to Brazil: fresh/frozen
beef, beef products, beef, pork, pork products, prepared foods, milk and
milk products (cheese, whey, butter, butter oil, lactose), and seafood
products (in this case provide the scientific name of the fish in Latin
and how the product will be shipped to Brazil).

Note: DIPOA officials do not register US poultry plants for export of
poultry products to Brazil.

B. Inspection Requirements for Plant Products

All unprocessed US products of plant origin (bulk grains, fresh fruits
and vegetables, nuts, and seeds) can only be exported to Brazil if
accompanied by an APHIS/PPQ phytosanitary certificate. Frozen fruits and
vegetables do not need a phytosanitary certificate. US exporters should
always check the nearest PPQ office or the APHIS home page to view the
latest import requirements and to see if there is a need to conduct a
Pest Risk Assessment (PRA) of the product before exporting to Brazil.

C. Pest Risk Assessments

On March 27, 2002, the Brazilian Government published Regulation Act n°
34, which requires Pest Risk Assessments (PRAs) for each species from
every country of origin. Given this and other changes occurring in this
area, US exporters should check with APHIS/Brasilia for additional
information on the status of Brazilian phytosanitary import
requirements.

Regulation Act n° 59 of November 21, 2002 establishes the procedures for
submitting PRAs to the Brazilian Government. It clarifies the pest risk
analysis methodology to be followed, and specifies that \"documentation
be submitted in Portuguese, and be reviewed by USDA/APHIS/PPQ.\"

US exporters need to be aware that PRAs will need to be done on
third‑country origin plant products that are re‑exported from the US to
Brazil, with information provided by the country‑of‑origin. Regulation
Act n° 60 of November 21, 2002, allows for the importation of plant
products traditionally imported by Brazil while the PRA is under review
by MAPA/DSV.

Questions about specific Brazilian import requirements can also be
directed to APHIS/PPQ at the following address:

Export Certification Unit Plant Protection and Quarantine (PPQ)

Animal and Plant Health Inspection Service (APHIS)

US Department of Agriculture

4700 River Road Unit 139

Riverdale, MD 20737‑1236

Tel: (301) 734‑8537

Fax: (301) 734‑5786

D. Inspection Requirements for Animal Genetics

The Department of Animal Health (DDA), Ministry of Agriculture,
Livestock and Food Supply (MAPA) is responsible for issuing animal
health requirements for imports of live animals, semen and embryos. In
addition, the Department of Surveillance of Livestock Inputs (DFIP) is
responsible for establishing genetic requirements for animal semen and
embryos, and the genealogical registration of live animals.

Before exporting live animals, semen or embryos to Brazil, the US
exporter should contact APHIS/VS at the following address:

National Center for Import and Export (NCIE)

Animal and Plant Health Inspection Service (APHIS)

US Department of Agriculture

4700 River Road Unit 39

Riverdale, MD 20737‑1231

Tel.: (301) 734‑7511

Fax: (301) 734-6402

E. Inspection Requirements for Animal Feed

US exporters of animal feed and fodder, including pet food, must be
registered with the Department of Surveillance of Agricultural Inputs
(DFIA). The US exporter of animal feed should first establish a legal
representative or importer in Brazil who will file the request for
registration of the imported product with DFIA/MAPA. The importer must
also be registered with the MAPA before submitting a request for
registration. A comprehensive questionnaire must be filled out,
including label information.

F. Veterinary Biologics

The importation of veterinary Biologics, such as vaccines, antiserums,
and diagnostic test kits, are subject to prior registration with the
Department of Surveillance of Livestock Inputs (DFIP), Ministry of
Agriculture, Livestock, and Food Supply (MAPA). DFIP does not register
growth promotants (hormones) for beef cattle, but does for dairy cattle.

The US exporter of veterinary biologics should first obtain an importer
(or a legal representative) in Brazil who will file the request for
registration of the imported product with DFIP/MAPA. The importer must
also be registered with MAPA before submitting the request for
registration. A comprehensive questionnaire must be filled out including
label information.

G. Alcoholic and Other Beverages

The Department of Surveillance of Agricultural Inputs (DFIA), Ministry
of Agriculture, Livestock, and Food Supply (MAPA) has the regulatory
authority to enforce federal laws regarding the registration and
labeling of beer, distilled spirits, wine, soft drinks, and juices. In
this respect, its regulatory responsibilities are similar to those
ascribed in the United States to the Department of Treasury's Bureau of
Alcohol, Tobacco, and Firearms (ATF), except that DFIA provides a
broader spectrum of services, including laboratory tests. The major
regulation for alcoholic and beverage products, both domestic and
imported, is Decree n° 4072 of January 3, 2002.

### VII. OTHER SPECIFIC STANDARDS 

A. Supplemental, Dietary, and Functional Foods

The import of infant formula, dietary, and supplemental foods is under
the responsibility of ANVISA. It follows the same procedures as those
for registration of processed foods, including the payment of a
registration fee for the registration of the company as well as the
product (see Ministry of Health section above).

The major regulations that provide regulatory framework for domestic and
imported functional and other specialty foods under the Ministry of
Health's ANVISA include: Decree n° 38, January 13, 1998; Decree n° 27,
January 13, 1998; Decree n° 29, January 13, 1998; Decree n° 30, January
13, 1998; Decree n° 222, March 24, 1998; Resolution n° 449, September 9,
1999 and Resolution n° 18 and n° 19, April 30, 1999.

B. Organic Foods

The rapid growth of organic farming in Brazil has prompted the Brazilian
government to regulate the sector. On May 17, 1999, the Minister of
Agriculture, Livestock and Food Supply (MAPA) published in the Diario
Oficial (Brazil's Federal Register) Regulation Act n° 7, which contains
the standards for production, classification, processing, packaging,
importation, distribution, identification, and certification of the
quality of organic products, of both animal and plant origin.

To use the term \"organic product\", both domestic and imported organic
products must be labeled with the name and registration number of the
certifying organization. For bulk products, a "certificate of organic
quality" must accompany the shipment. The Office of Agricultural
Protection (SDA) of the Ministry of Agriculture, Livestock and Food
Supply (MAPA) has the authority regarding import approval of organic
products.

The legal framework for organic foods in Brazil may be found under MAPA:
Regulation Act n° 7, May 17, 1999; Regulation Act n° 16, June 11, 2004
and Law n° 10831, December 23, 2003.

### VIII. COPYRIGHT AND TRADEMARK LAWS 

The National Institute of Industrial Property (INPI) is a federal agency
created in 1970, and linked to the Ministry of Development, Industry and
Foreign Trade (MDIC) responsible for protecting patents, trademarks, and
copyrights. INPI is currently regulated by Law 9,279/96 (Industrial
Property Law). Registration of a trademark in Brazil may be obtained by
filing an application letter to INPI. Once registered, the validity of
the registration is for 20 years.

According to trade specialists, despite recent improvements, Brazil
continues to fall short in providing adequate and effective protection
of Intellectual Property Rights (IPR). Although Brazil is one of the
largest markets globally for legitimate copyrighted products, it is also
one of the world's largest markets for pirated products. For general
information on legislation, regulations, application for copyrights,
patents, and trademarks, please access INPI home page at
<http://www.inpi.gov.br/>.

### 

### IX. IMPORT PROCEDURES 

The import process in Brazil can be divided into 3 phases:

-   Administrative: regulates all import actions and its bureaucracy. It
    comprises procedures established by the Secretariat of Foreign Trade
    (SECEX) and any other government department in charge of releasing
    import authorization or goods clearance. The main Brazilian
    Government offices involved in import of food and beverage products
    are: the Ministry of Agriculture, Livestock and Food Supply (MAPA)
    and the Ministry of Health (MS) through ANVISA.

-   Currency operations: comprise monetary transfers to other countries,
    which are controlled by the Brazilian Central Bank (BACEN) and
    processed through private banks under BACEN authorization.

-   Fiscal: taxes and tariff payments are controlled by the Secretariat
    of Federal Revenue (SRF)

In order to start the import process, the local company must request a
permit on the online registration system. Once the company receives the
permit, eligibility to import is granted. After that, a series of
actions will take place, which are the importer's responsibility.

A. Registration

The registration of imported foods and their production sites must be
accomplished prior to shipment. For products of animal origin under
MAPA's surveillance, the processing plant must be registered and
approved by the Brazilian government. Brazilian importers must also
pre-register the labels of processed meats, dairy and seafood products.

ANVISA is also responsible for registration of a great variety of
processed food products. Before placing a food product in the market,
importers must obtain a registration number, which should be placed on
the product label. Questions about specific Brazilian registration
requirements can also be directed to ATO Sao Paulo.

B. Classification

The international methodology of goods classification, based on an
arrangement of codes and descriptions is called the Harmonized Commodity
Description and Coding System or simply the Harmonized System (HS). The
code composition of the HS, formed by six digits, allows product
specifications to be attended, such as: origin, constitution and
application, in a logical ascending numeric order, according to its
level of complexity.

Brazil, Argentina, Paraguay and Uruguay have adopted the Mercosul Common
Nomeclature (NCM), which has the HS as its base. Therefore, out of the
eight digits that form the NCM, the HS forms the first six digits, while
the seventh and the eighth digits correspond to specifications endorsed
in the Mercosul sphere. Through the NCM it is possible to define what is
the amount of taxes to be payed and which government office will release
import authorization. Each product classified under a NCM code requires
an import license, therefore invoices containing products with different
classifications will need separate import licenses.

C. Administrative Process

A *Pro forma* invoice should be sent to the Brazilian exporter. This
document starts up the entire process, therefore it is extremely
important that exporters fill out this document properly, otherwise the
Brazilian importer will not be able to file the application. The
importer requests an import permit also called Import License (LI),
which is obtained before shipment or during the clearance process. All
food and beverage products are under MAPA and MS prior approval.

D. Shipping

Along with the shipment, the exporter must send the documentation that
will allow the importer to release goods from Brazilian customs. The
documentation required includes: shipping information (bill of lading or
AWB), commercial invoice (including details of agreed payment method),
certificate of origin (for products falling under international
agreements) and phytosanitary or lab certificate (when required by
Brazilian law).

E. Payment

Overseas payment may be made in advance, by collection or by letter of
credit (cash or installments). A foreign exchange contract, according to
the standards and regulations established by the Brazilian Central Bank,
formalizes the buying and selling of foreign currency between the
importer and an authorized exchange establishment. The exchange
transactions may be made for immediate or delayed payment. The time
between signing the contract and payment of the transactions must not
exceed 360 days.

F. Clearance

Starts when goods arrive in Brazil. The importer or a contracted customs
broker, officially representing the importer, will prepare the Import
Declaration (DI). The necessary documentation to fill out the DI is:
commercial invoice, shipping information and the LI. In addition, to
register the DI, the importer needs to pay Import Tax (II) and Tax on
Manufacture (IPI). Other documents may be required due to special
characteristics of the product and/or transaction.

Clearance from customs consists of a series of acts carried out by a
customs official who will authorize the release of the goods to the
importer after the verification of: merchandise, compliance with tax
laws and importer's identity. The SRF will release an Import Warrant
(CI) via SISCOMEX to confirm customs clearance. The system will then
automatically select the method of clearance to be applied. They are:

-   green: customs clearance authorization is automatically issued.

-   yellow: mandatory inspection of documentation is required and, if no
    evidence of irregularities is found, customs clearance authorization
    is issued.

-   red: mandatory inspection of documentation and of merchandise is
    required before customs clearance authorization is issued.

-   gray: mandatory inspection of documents, merchandise, and taxable
    basis of Import Tax is required before customs clearance
    authorization is issued. Customs clearance authorization can be
    arranged before conclusion of the inspection of customs value, by
    using a guarantee issued by the importer.

Except for the green option, all documents with the receipt of the
Import Declaration printed by SISCOMEX and proof of payment on waiver of
the Interstate Movement Tax on Sales and Services (ICMS), should be
presented by the importer (to the Federal Revenue Office where the goods
are located) to conclude customs clearance. For goods assigned the gray
option, a Declaration of Customs Value (DVA) must be made and
transmitted via SISCOMEX to explain the commercial aspects of the
transaction and to provide additional information to justify the value.
Any corrections to the information presented in the DI, changes in the
calculation and additional tax or fines required by law, will be carried
out in accordance with SISCOMEX procedures.

## 

Since 1990, Brazil has eliminated a number of non-tariff barriers to
imports, and lowered most import duties on commodities and foods. Import
duties vary from 8-14 percent for most bulk agricultural products and
14-23 percent on highly processed food products. Today, Brazil, together
with its MERCOSUL partners (Argentina, Uruguay, and Paraguay), applies
the MERCOSUL Common External Tariff (CXT). Mercosul members enjoy
duty-free entry to Brazil while Chile and Bolivia, as associate members
of MERCOSUL, benefit from preferential import tariffs.

APPENDIX I -- GOVERNMENT REGULATORY AGENCY CONTACTS

Secretariat of Agricultural Protection (SDA) Brazilian Environment
Institute (IBAMA)

Ministry of Agriculture, Livestock, and Food SAIN - Av. L 4 Norte

Supply (MAPA) 70800-200 Brazilia, DF

Esplanada dos Ministerios, Bloco D Phone: (55-61) 3226-8221

Anexo B, 4 Andar, Sala 406 Fax: 3322-1058

70043-900 Brasilia, DF Home page: <http://www.ibama.gov.br/>

Phone: (55-61) 3218-2314/15

Fax: (55-61) 3224-3996 or 3218-2316

Home page: <http://www.agricultura.gov.br/>

Secretariat of International Relations of the Ministry of Science &
Technology (MCT)

Agribusiness (SRI) Esplanada dos Ministerios, Bloco E

Ministry of Agriculture, Livestock and 70067-900 Brasilia, DF

and Food Supply (MAPA) Phone: (55-61) 3321-8886

Esplanada dos Ministerios, Bloco D, 3 Andar Fax: (55-61) 3225-7496

Sala 304 Home page: <http://www.mct.gov.br/>

70043-900 Brasilia, DF

Phone: (55-61) 3321-3594

Fax: (55-61) 3321-4524

Home page: <http://www.agricultura.gov.br/>

Agency of Sanitary Surveillance (ANVISA) Ministry of Justice

Ministry of Health Esplanada dos Ministerios, Bloco T

Esplanada dos Ministerios, Bloco G 70064-900 Brasilia, DF

70058-900 Brasilia, DF Phone: (55-11) 3224-0954

Phone: (55-61) 3315-2343 Fax: (55-61) 3322-6817

Fax: (55-61) 3225-6056 Home page: <http://www.mj.gov.br/>

Home page: <http://www.saude.gov.br/>

Ministry of Development, Industry and Brazilian Customs (Receita
Federal)

Foreign Trade (MDIC) Ministry of Finance

Esplanada dos Ministerios, Bloco J Esplanada dos Ministerios, Bloco P

70056-900 Brasilia, DF 70048-900 Brasilia, DF

Phone: (55-61) 3329-7000 Phone: (55-61) 3412-3000

Fax: (55-61) 3329-7230 Fax: (55-61) 3412-1721

Home page: <http://www.mdic.gov.br/> Home page:
<http://www.fazenda.gov.br/>

APPENDIX II -- OTHER IMPORT SPECIALIST CONTACTS

American Chamber of Commerce Sao Paulo

Rua Alexandre Dumas, 1976

04717-004 Sao Paulo, SP

Phone: (55-11) 246-9199

Fax: (55-11) 246-9080

Home page: <http://www.amcham.com.br/>

Brazilian Food Processors' Association (ABIA)

Av. Brigadeiro Faria Lima, 1478, 11 Andar

01451-001 Sao Paulo, SP

Phone: (55-11) 3030-1353

Fax: (55-11) 3814-6688

Home page: <http://www.abia.com.br/>

Brazilian Association of Food and Beverage Importers and Exporters
(ABBA)

Rua Machado Bitencourt, 190, cj.609

04044-000 Sao Paulo, SP

Phone: (55-11) 5087-9546

Fax: (55-11) 5571-7290

Home page: <http://www.aabba.org.br/>

For additional information on this report, please contact one of the
following FAS offices in Brazil:

**Office of Agricultural Affairs (OAA) Agricultural Trade Office (ATO)**

American Embassy, Brazilia Rua Henri Dummont, 700

Av. das Nacoes, Quadra 801, lote 3 04709-110 Sao Paulo, SP

70403-900 Brasilia, DF Phone: (55-11) 5186-7400

Phone: (55-61) 3312-7101 Fax: (55-11) 5186-7499

Fax: (55-61) 3312-7659 E-mail:
[atosaopaulo@fas.usda.gov](../atosaopaulo@fas.usda.gov)

E-mail: [agBrasilia@fas.usda.gov](../agBrasilia@fas.usda.gov%20)
[atobrazil@usdabrazil.org.br](../atobrazil@usdabrazil.org.br)

Home page: <http://www.usdabrazil.org.br/>