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European Commission
Directorate-General for Trade
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Contents
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Import Licensing
The tariff codes assigned to the document entitled Automatic Import Licence (i.e. the classification of goods pertaining to said
document) have been updated in accordance with the official list recently published by the Subsecretariat for Foreign Trade
Operations (SUEXT) of the Secretariat of Foreign Trade (SECEX) under the Ministry of Economy (Ministério da Economia).
Please refer to the quoted document and the chapter on Import Licensing in this overview for particulars on this measure.
Other Changes
Current trade-related News have been brought to the following paragraph; please turn thereto for specifics.
News
General Information
Area: 8,515,770 sq km
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Capital: Brasilia
Major ports: Belem, Manaus, Paranagua, Rio Grande, Rio de Janeiro, Santos, Sao Sebastiao, Tubarao
Customs airports: Aracajú (AJU), Belém (BEL), Belo Horizonte (BHZ), Boa Vista (BVB), Brasilia (BSB), Cabo Frio International Airport (CFB), Campinas (VCP), Campo Grande
(CGR), Campos (CAW), Corumbá (CMG), Curitiba (CWB), Florianópolis (FLN), Fortaleza (FOR), Foz do Iguaçu (IGU), Goiânia (GYN), João Pessoa (JPA), Joinville (JOI),
Londrina (LDB), Macapá (MCP), Maceió (MCZ), Manaus (MAO), Navegantes (NVT), Petrolina (PNZ), Porto Alegre (POA), Porto Velho (PVH), Recife (REC), Rio de Janeiro
(GIG), Salvador (SSA), São Gonçalo do Amarante (NAT), São José dos Campos (SJK), São Luís (SLZ), São Paulo (GRU), Teresina (THE), Vitória (VIX)
Note
The tariff codes correspond to the current Brazilian customs tariff based on the Common External Tariff (AEC), which has been
established on the basis of the Southern Common Market (MERCOSUR) Common Nomenclature (NCM). The AEC, in turn, is
based on the Harmonized System (HS) 2017; Brazil applies the HS on the basis of the HS Convention (for further general
information on the Harmonized System, please turn to the section thereon below).
International Agreements
Brazil is a member of the following treaties and has signed the agreements listed below:
Customs Convention on the A.T.A. Carnet for the Temporary Admission of Goods (A.T.A. Convention), please refer to the document Carnet A.T.A. for further details
International Convention on the Harmonized Commodity Description and Coding System (HS Convention)
Organization for Economic Co-operation and Development (OECD) - enhanced engagement country status
Preferential Treatment
Brazil is a member of the Southern Common Market (MERCOSUR) and thus part of a customs union along with Argentina,
Paraguay and Uruguay. By means of a decision published on 5 August 2017, Venezuela was suspended from all rights and
obligations connected to the MERCOSUR membership due to the breakdown of democratic order in the country. Bolivia is
currently in the process of accessing to the MERCOSUR. Brazil is also a member of the Latin American Integration Association
(LAIA, Associação Latino-Americana de Integração - ALADI), comprising Argentina, Bolivia, Brazil, Chile, Colombia, Cuba,
Ecuador, Mexico, Panama, Paraguay, Peru, Uruguay and Venezuela, which has the final aim to introduce a common Latin
American market. Brazil furthermore participates in the Global System of Trade Preferences among Developing Countries
(GSTP).
As a member of the MERCOSUR, Brazil participates in free trade agreements (FTAs) which have been concluded between the
MERCOSUR and Bolivia, Chile, Colombia, Ecuador, Egypt, Israel and Peru. In addition, a framework agreement exists between
the MERCOSUR and Mexico which aims at creating an FTA between both parties.
Brazil moreover participates in the partial preferential agreement which has been concluded between the MERCOSUR and the
South African Customs Union (SACU), consisting of Botswana, Eswatini (formerly: Swaziland), Lesotho, Namibia and South
Africa. Furthermore, a partial preferential agreement for the automobile sector has been signed between the MERCOSUR and
Mexico on the basis of the above-mentioned framework agreement. As MERCOSUR member, Brazil has furthermore
concluded partial preferential agreements with Cuba and India.
A bilateral FTA is in force between Brazil and Venezuela. Furthermore, bilateral partial FTAs exist with Argentina, Guyana,
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Goods which are originating products in the sense of the agreements above may benefit from preferential treatment in Brazil.
Export Controls
Besides the stipulations of the country of importation, export control provisions may have to be observed in international
movements of goods and services. The subject of such provisions may be particular commodities, countries of (final)
destination and legal or natural persons involved in the respective transactions. These persons may comprise, but are not
limited to, the following legal entities or individuals:
end users
The listed entities may include governmental agencies in the country of (final) destination, too.
Countries may even partially or completely interdict external trade with another country. However, goods may also be exempt
from such embargoes if exported for humanitarian or special reasons.
In general, the following types of merchandise (as well as related services and maintenance) are regulated in the framework of
export control laws:
military equipment
dual-use goods, i.e. commodities which may be used for military and civil purposes alike (including software and technologies)
goods which could be used for torture, capital punishment or similarly inhuman treatment.
In principle, the competent authorities of the exporting country regulate the scope of goods to be controlled upon their
exportation and in respect of the parties and countries involved in the transactions. Following the examination of the relevant
documentation, export authorisations may be issued. The export control authorities may also require documents from the
respective bodies in the country of destination in order to control the goods and monitor their delivery chains. Such documents
may comprise, e.g., international import certificates, end-user certificates or delivery verification certificates.
In addition, specific import requirements may apply to the abovementioned goods as well. Further information as regards
control measures applicable in Brazil may also be viewed in the section on Weapons, Ammunition and Explosives below.
As regards controls of dual-use goods in the framework of the European Union (EU), the basic legal stipulation is Council
Regulation (EC) No 428/2009 of 5 May 2009, setting up a Community regime for the control of exports, transfer, brokering and
transit of dual-use items. The responsibility for the execution of the so-called Dual-Use Regulation lies, however, with the
competent authorities of each individual Member State.
Exporters should be aware of the fact that they may be held legally responsible for respective foreign trade transactions,
comprising all different aspects of transboundary movements of goods and services. This individual responsibility is usually not
transferable to other persons. Advice should be sought from the competent authority in the exporting country.
Registration
Importers are required to register with the Special Secretariat of Federal Revenue of Brazil (RFB) of the Ministry of Economy
(Ministério da Economia). The RFB maintains the controlling system RADAR, which serves to track all activities and to control
legal entities that operate in Brazilian foreign trade and which incorporates the registration of economic operators with the
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Integrated Foreign Trade System (Siscomex). Access to Siscomex is required for carrying out customs formalities and obtaining
import licences and approvals from the responsible government agencies, as detailed in the sections on Customs Procedures
and Import Licensing below. In order to gain access to Siscomex, the legally responsible person of the company must register
with the RFB. Afterwards, the legally responsible person may authorise the company's representatives to conduct activities
related to the customs clearance of goods for the company in question within Siscomex. Details of these procedures may be
consulted in the documents entitled Registration of the Legally Responsible Person in Siscomex and Registration of Legal
Representatives in Siscomex. The legal bases for the access to Siscomex are provided in Normative Instruction RFB No. 1603
of 2015 and Ordinance Coana No. 123 of 2015 (as amended).
Furthermore, importers must have been entered in the Register of Exporters and Importers (REI) of the Secretariat of Foreign
Trade (SECEX) under the Ministry of Economy. This registration is created automatically when processing the first import or
export operation through Siscomex.
Public Procurement
The Brazilian Government regulates the national market with the adoption of public procurement measures. Currently, the legal
stipulations generally allow for the preference of Brazilian goods over foreign produce if their price does not exceed the
preference margin of 25%. The legal framework for public procurement measures is given in the consolidated version of Law
No. 8,666 of 21 June 1993.
Customs Procedures
As a member of the Southern Common Market (MERCOSUR), Brazil is to adopt the MERCOSUR Customs Code (CAM), which
has been approved in 2010. However, this common customs legislation is not in force yet, as it is in the process of being
implemented into the legal systems of the member states.
The Brazilian Customs Regulation mainly differentiates between the following types of customs procedures for imports:
transit
temporary admission
drawback
customs warehousing
Siscomex operations may be performed by the importer or through his accredited representative, e.g. the customs broker. A
previous registration with the RFB is required for the importer (responsável legal) as well as his representative (representante).
Please see the section on Registration above for further details of this registration.
As a part of Siscomex, the automated electronic cargo control system Siscarga allows for the control of vessel arrivals and
departures as well as of the movement of freight at the ports and the delivery of goods through the depositary. In case of air
freight, the control system Mantra, another part of Siscomex, is used. Please also refer to the document entitled Cargo
Manifest.
The nomination of a customs agent who will act on behalf of the importer is not mandatorily required by the Brazilian customs
legislation. Articles 808 and 809 of Decree No. 6759 of 5 February 2009 provide the legal framework for the admissible
representation relationships of the importer before the customs authorities.
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The portal Siscomex is developed and implemented by the National Trade Facilitation Committee (Comitê Nacional de
Facilitação de Comércio) of the Brazilian Chamber of Foreign Trade (CAMEX) under the Ministry of Economy (Ministério da
Economia) together with further bodies of the same Mnistry as well as a number of authorities, e.g. the National Health
Surveillance Agency (ANVISA), the Central Bank of Brazil (BCB) and the National Institute of Metrology, Quality and
Technology (INMETRO). It contains, e.g., the system Vicomex, which allows importers, exporters and their legal representatives
to check up the current status of their foreign trade operations. This system furthermore allows the submission of the
documents accompanying the Customs Import Declaration or documents for import procedures controlled by further authorities
(e.g. the Supervisory Board of International Agriculture and Cattle Raising - VIGIAGRO) electronically via the attachment
module (Anexação de Documentos).
According to Art. 711 of Decree No. 6759 of 5 February 2009, a penalty of 1% of the customs value may be imposed if the
importer omits necessary information for determining an appropriate customs control procedure, including the complete
identification and address of the manufacturer. Therefore, the customs authorities may require these details to be contained,
e.g., in the Commercial Invoice.
The documents accompanying the Customs Import Declaration are to be submitted electronically via the attachment module
(Anexação de Documentos) of the system Vicomex of the single portal for foreign trade (Portal Único de Comércio Exterior).
The digital documents must be signed by means of an electronic signature based on a digital certificate.
In case of goods of a value of 3,000 USD or below, a Simplified Import Declaration may be handed in. The supporting
documents for the Simplified Import Declaration are still to be submitted in paper form. Please refer to the mentioned document
for further details.
On the basis of the Customs Import Declaration, the Brazilian customs authorities select the goods in question for one of four
customs clearance channels (parametrização). Depending on the approved channel, accelerated customs clearance of the
goods may be provided for:
yellow channel: verification of the Customs Import Declaration and its supporting documentation
red channel: same requirements as apply under the yellow channel; additionally, the goods will be physically inspected
grey channel: same requirements as apply under the red channel; additionally, special customs clearance procedures will be performed in order to investigate indications of fraud,
e.g. concerning the declared price of the goods.
In addition, the single import declaration (Declaração Única de Importação - DUIMP) has been introduced for companies
certified as level 2 authorised economic operator (AEO, operador econômico autorizado - OEA) in the category OEA-C. The
declaration may be processed via the single portal for foreign trade (Portal Único de Comércio Exterior) and may be used for
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sea freight as well as for goods with full tax collection. Moreover, the DUIMP may be submitted before the arrival of the goods
and generally in parallel to obtaining import licences. For further information on the AEO programme, please refer to the
following section.
OEA-Conformidade (OEA-C; focus on compliance with tax and customs obligations), divided into level 1 and level 2
OEA-Pleno (OEA-P; being in possession of both OEA-S and OEA-C level 2 certification).
Certified AEOs may take advantage from benefits related to the facilitation of customs procedures. There are general benefits
as well as specific benefits granted in accordance with the chosen AEO type. Companies may generally benefit from, e.g.,
Mutual Recognition Agreements (MRAs), direct communication channels to the RFB and the use of the Brazilian AEO logo.
Furthermore, by way of example, as specific benefits for OEA-C level 1 and 2, imported goods enjoy priority treatment as
regards their storage and remain under custody of the depositary until they are submitted to customs clearance. The blue
channel, an express customs clearance channel formerly established by the RFB, has been substituted by the AEO
programme.
The AEO programme is currently in its third implementation phase, namely the OEA-Integrado, during which further Brazilian
authorities involved in foreign trade are to be integrated into the programme, e.g. the Secretary of Agricultural Protection (SDA)
under the Ministry of Agriculture, Livestock and Food Supply (MAPA) and the Brazilian Army.
As a prerequisite for AEO certification, interested companies must fulfil a number of requirements, which are divided into
admission requirements, eligibility criteria and specific criteria depending on the AEO type and the economic operator. The
admission requirements comprise, inter alia, registration with the National Register of Legal Persons (CNPJ), having an
electronic tax address (DTE) and proving the compliance with taxes.
private customs warehouses, which are privately run, but open to the public
particular private customs warehouses mainly for industrial producers who store their goods under customs control (RECOF).
If imported for customs warehousing in a regular public or private customs warehouse (entreposto aduaneiro), goods may stay
in the conceded warehouse for one year. This period may be extended to three years at the maximum.
Goods imported for industrial warehousing (RECOF) and inward processing under customs supervision must be declared for
this procedure upon their entry into the Brazilian customs territory. Usually, the goods are re-exported again after their
processing, assembling or finishing. Certain fiscal incentives, i.e. refunds, suspensions and exemptions, may be applied in the
scope of this special procedure. In practice, the Ministry of Economy mainly differentiates between the two types of duty
drawback described below:
This regime is available for goods imported for usage or consumption in the industrial inward processing of other goods to be exported. The import duties and consumption taxes
as applicable under other customs regimes will not be charged. Corresponding applications are to be made via Siscomex.
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This regime is available for goods imported as a substitute for those consumed during inward processing. Importations under this scheme are exempt from payment of certain
import duties. Corresponding applications are to be made to the Bank of Brazil (Banco do Brasil).
The above-noted facilitations are granted for the period during which the inward processing is effected and for a maximum
period of one year.
Regardless of the applied fiscal incentives, the Ministry of Economy (Ministério da Economia) may demand that the importer
deposits a security or a letter of indemnity upon the importation of goods to be re-exported. The importer is obliged to submit
the goods exclusively to the intended purpose and to provide for the clear identification of the goods at any point during their
warehousing. If goods are not removed from the warehousing facility after the expiry of the permissible warehousing period, the
accrued duties will be charged regardless of the originally foreseen duty relief scheme. Goods released from the warehousing
facility not for re-export but for home consumption in Brazil will be subjected to a charge calculated under account of the kind
and quantity of the raw materials and components used in these products.
Next to said fiscal incentives, a number of technical particularities relate to the entry of goods for inward processing in an
industrial warehouse RECOF. Consequently, the following details are to be approved by the competent authority:
the maximum quantity of imported goods that may be deposited in the warehouse
the minimum percentage of the total production that must be re-exported so that the performed transformation is eligible for inward processing.
Temporary Admission
Goods may be imported under the customs regimes of temporary admission with complete tax exemption, temporary admission
for economic use and temporary entry for inward processing. The temporary admission under complete tax exemption may be
chosen for determined goods comprising, inter alia, goods intended for scientific, technical, educational, commercial or
industrial events, goods intended for product testings or for the development of products or prototypes, as well as animals for
expositions and fiscal control stamps issued by foreign countries intended to be used for national or nationalised products to be
exported to these countries. A complete list may be consulted in Normative Instruction No. 1600 of 14 December 2015 (as
amended). The period of validity of this regime is six months and may be extended to further six months. A guarantee is not
required.
The procedure of temporary admission for economic use allows for the temporary importation of goods intended for the
provision of services to third parties or for the production of other goods intended for sale. The federal taxes due upon
importation must be paid proportionally to the time the goods are intended to remain in Brazil. The period of validity may be up
to 100 months as determined in the contract of operational leasing, the rental agreement or the loan agreement between the
importer and the foreign person. The period indicated in the application for temporary admission may, however, be rejected by
the Special Secretariat of Federal Revenue of Brazil (RFB) if it is considered inappropriate for the purpose of import for the
product in question. The guarantee to be paid is equivalent to the amount of the suspended taxes.
The temporary admission for inward processing allows for the temporary importation of goods intended for inward processing
and subsequent re-export under tax exemption. The period of validity depends on the agreement in the service contract
between the importer and the foreign person. No guarantee must be paid.
Brazil is furthermore a member of the Customs Convention on the A.T.A. Carnet for the Temporary Admission of Goods (A.T.A.
Convention), which allows for the temporary importation of goods intended for exhibitions, commercial samples or items of
professional equipment. Further information thereon may be found in the document entitled Carnet A.T.A..
Customs Value
The customs value of imported goods is the transaction value, which is the price paid or payable for the goods when imported
into the customs territory of Brazil. Rules on determining the customs value are applied according to the Agreement on
Implementation of Article VII (Customs Valuation) of the General Agreement on Tariffs and Trade (GATT) 1994.
If the customs value cannot be determined on the basis of the transaction value, the following values are to be applied
successively as a basis for its calculation:
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There are eight free trade zones in Brazil, of which Manaus is the most important one to foreign exporters. In 2014, the special
tax incentives granted within the Free Zone of Manaus (ZFM) have been extended until 2073. Companies which operate in said
zone may usually import goods with the abovementioned benefits after obtaining approval from the Superintendence of the
Free Zone of Manaus (SUFRAMA). These incentives do not apply to arms and ammunition, tobacco, alcoholic beverages,
passenger motor vehicles or certain cosmetic products which are intended for exclusive use in the zone or which have been
produced with raw materials of the regional fauna and flora. For more information on importation into the ZFM, please contact
the Superintendence of the Free Zone of Manaus = Superintendência da Zona Franca de Manaus (SUFRAMA), Aven. Ministro
Mário Andreazza 1424, Distrito Industrial, BR-69075830 Manaus, phone number: +55 92 33217000, fax number: +55 92
32376549.
Import Licensing
The Brazilian import licensing regime includes automatic and non-automatic licences. Applications for both types of licences are
usually to be submitted electronically via the Integrated Foreign Trade System (Siscomex). Non-automatic import licences must
generally be obtained prior to the shipment of the goods, whereas automatic import licences may be applied for after the
departure of the consignment from the country of export but before the start of the customs clearance in Brazil.
Automatic import licences are to be applied for at the Subsecretariat for Foreign Trade Operations (SUEXT) of the Secretariat of
Foreign Trade (SECEX) under the Special Secretariat for Foreign Trade and International Affairs (SECINT) which operate under
the Ministry of Economy (Ministério da Economia). Non-automatic import licences are instead either subject to the control of the
SUEXT or of other agencies and governmental institutions, depending on the category of the product for which the licence is
applied for, e.g. the National Health Surveillance Agency (ANVISA) or the Ministry of Agriculture, Livestock and Food Supply
(MAPA).
The scope of products subject to non-automatic and automatic import licensing is regularly being updated and published on the
website of the Ministry of Economy under http://www.mdic.gov.br/index.php/comercio-exterior/importacao/tratamento-
administrativo-de-importacao. The current state of administrative treatment may also be consulted in the following search page:
https://siscomex.desenvolvimento.gov.br/tratamento/private/pages/consulta_tratamento.jsf.
For further information on the procedural details, please see the following documents:
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Prohibited Goods
The official lists of goods prohibited from importation published by the Subsecretariat for Foreign Trade Operations (SUEXT)
under the Ministry of Economy (Ministério da Economia) are reflected in the document entitled Prohibited Imports. It comprises,
e.g., retreaded or used pneumatic tyres. Moreover, goods falling under the customs tariff chapters 1 to 38 are banned from
being imported if in a used condition, as stipulated in the aforementioned official lists.
Further import bans are stipulated by separate legal provisions. By way of example, according to Ordinance SECEX No. 23 of
14 July 2011 (as amended), the importation of used consumer goods is prohibited. The section on Used Goods presents a list
of goods which are importable in used condition. Please turn thereto for more information.
Normative Instruction MAPA No. 12 of 2016 prohibits the importation of any type of soil, including soil adhered to propagative
material, whether imported as a commodity or as a contaminant present in other consignments. Moreover, in accordance with
Decree No. 24.114, the importation of plants and parts of plants that carry dangerous diseases as well as harmful live insects,
pests, bacteria and fungi is forbidden.
Furthermore, as detailed in the sections on Waste and Chemical Substances and Hazardous Goods, the importation of
certain waste or ozone-depleting substances (ODS) is also forbidden. For more information on these kinds of products, please
contact the Brazilian Institute for Environment and Renewable Natural Resources (IBAMA) under the Ministry of the
Environment (MMA).
additives
contaminants (e.g. heavy metals, residues of pesticides or veterinary drugs, extraneous matter).
SPS measures may be included in the relevant laws, decrees, regulations, requirements and procedures of a country or an
economic community.
The Agreement on the Application of Sanitary and Phytosanitary Measures of the World Trade Organization (WTO), also
referred to as SPS Agreement, sets out the rules that the WTO member states are obliged to follow when they implement SPS
measures governing food and feed safety, animal health and plant health. Said Agreement applies to all SPS measures which
may, directly or indirectly, affect international trade. Every WTO member has the right to take respective measures to pursue the
abovementioned protection goals. Under the WTO rules, countries are allowed to set their own standards, but their regulations
are required to be based on scientific evidence and international standards, i.e. the imposed measures must be transparent and
comprehensible. WTO members are to notify the content of a proposed sanitary or phytosanitary regulation, whether new or not
substantially the same as the content of an international standard, guideline or recommendation, and the covered products to
the WTO in advance.
International organisations working towards an international harmonisation of SPS measures include the World Organisation for
Animal Health (OIE, former Office International des Epizooties, for animal health), the International Plant Protection Convention
(IPPC, for plant health) and the Codex Alimentarius Commission (a joint Commission of the Food and Agriculture Organization
(FAO) and the World Health Organization (WHO), for food safety). In addition, the SPS Agreement offers technical assistance
to developing countries with regard to capacity building and programmes concerning food safety, animal and plant health.
SPS measures must be in proportion to the potential risk involved and must be equally applied to national and imported goods.
These measures may take various forms, such as requiring products to come from disease-free areas, specific treatment or
processing of products, prescribing an inspection of products, quarantine regulations, setting the allowable maximum levels for
pesticide residues, or permitting the use of only certain additives in food.
For any merchandise potentially bearing SPS risks, comprehensive risk assessment measures usually apply in order to
ascertain whether the good is importable or not. This holds true in particular for animal or plant species or products which have
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previously not been traded between two countries. In the course of establishing the health standards to be met for a certain
good, specific conditions under which the particular item will be importable are usually defined, e.g. the mandatory fumigation
treatment of designated plant produce or the vaccination of particular animal species against their characteristic diseases. Such
terms are then reflected in the respective health certificate (i.e. those certificates mentioned in the chapters on animals, plants
and products thereof in this overview).
Furthermore, a pre-listing mechanism has been established for producers of animal products for human consumption intended
for exportation to Brazil. Consequently, only consignments originating from listed production sites are admitted into the country.
The production cycle and the premises of the company in question are to satisfy a number of sanitary requirements, whilst the
monitoring approach of the entrusted regulatory authority in the country of export is evaluated on an administrative level. Only if
both, the producing and the monitoring entity, prove their reliability, the goods are lawfully importable into Brazil. A list of
accordingly approved producers is held by the responsible Brazilian authority, the Department of Inspection of Products of
Animal Origin (DIPOA) under the Secretary of Agricultural Protection (SDA) of the Ministry of Agriculture, Livestock and Food
Supply (MAPA). In order to thoroughly examine the production and monitoring conditions in the country of export, the MAPA
provides for inspection missions to the interested exporting state.
Moreover, animal products as well as their respective labels must be registered with the DIPOA. For further details, please turn
to the document entitled Registration of Foodstuffs of Animal Origin. The registration number allocated to foodstuffs of animal
origin is to appear on the issued health certificate. Non-Automatic Import Licences and Permits to Import Products of Animal
Origin are also only issued if proof of successful registration with the MAPA is supplied. Particular requirements for the product
labels to be registered are specified in said document and in the section on Marking and Labelling Requirements below.
Importers of pure-bred breeding animals must present a Pedigree Certificate from the country of origin in order to import this
kind of animals.
Shipments containing live animals must be accompanied by a certificate confirming that the products to be imported do not
carry infectious diseases. Specific protective measures may apply to the importation of certain live animals and animal
products, e.g. as a consequence of the outbreak of contagious diseases. For further information on the animal health status of
the countries of origin and exportation, the World Animal Health Information System (WAHIS), a service provided by the World
Organisation for Animal Health (OIE), should be consulted. It is also advisable to contact the importer for advice on import
prohibitions.
With regard to species covered by CITES, please see the section below.
For details about the abovementioned procedures, please refer to the following documents:
Declaration of Responsibility
Pedigree Certificate
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With regard to issues concerning Sanitary and Phytosanitary (SPS) Measures, amongst others (please also refer to the same-
named section above), the authority responsible for veterinary controls of live animals and animal products in Brazil may be
contacted as follows: Animal Health Department, Secretary of Agricultural Protection, Ministry of Agriculture, Livestock and
Food Supply = Departamento de Saúde Animal (DSA), Secretaria de Defesa Agropecuária (SDA), Ministério da Agricultura,
Pecuária e Abastecimento (MAPA), Esplanada dos Ministérios, Bloco D, Anexo - Ala B, 4º andar, Sala 450, BR-70043900
Brasilia, phone numbers: +55 61 32182675, 32182716.
Depending on the category, different import requirements exist. Except for plant products of category 0, which do not require
phytosanitary control by the MAPA, plants and plant products of all other categories require a physical inspection carried out by
the local officials of the Supervisory Board of International Agriculture and Cattle Raising (VIGIAGRO) under the MAPA and a
prior registration of the importer with said authority. Moreover, they are subject to an import authorisation, if applicable. In case
of categories 2 and 3, the following documents are additionnally required: a Phytosanitary Certificate, a previous authorisation
from the Service for Agricultural Inspection (SEFAG) of the MAPA (only in case of ingredients for animal fodder), an Automatic
or Non-Automatic Import Licence (if applicable), a copy of the Commercial Invoice and a copy of the Bill of Lading or Cargo
Manifest. Depending on the type of commodity, specific additional declarations must be given on the Phytosanitary Certificate.
For the requirements for plants and plant products of category 4, please refer to the section on Seeds and Seedlings below.
Companies intending to enter fertilisers and similar substances into Brazil as well as the products to be imported must be
registered with the MAPA. Moreover, an import permit as well as an inspection must be applied for for each consignment.
Certain types of fertilisers must be accompanied by a Phytosanitary Certificate.
Phytosanitary Certificate
Registration of Fertilisers
Furthermore, a Pest Risk Analysis (PRA) is to be conducted on new plants, parts thereof, plant products and sub-products. The
quoted document may be consulted for more information. Commodities falling under risk categories 0 and 1 are exempt from
the requirement of a PRA.
Please see the respective paragraph of the section on Marking and Labelling Requirements below for the information to be
provided on the labels of fertilisers, inoculants and correctives.
As indicated in the chapter on Prohibited Goods above, the importation of any type of soil as well as plants and parts of plants
that carry dangerous diseases and harmful live insects, pests, bacteria and fungi is forbidden.
The authority responsible for phytosanitary control in Brazil may be contacted as follows, inter alia concerning issues of
Sanitary and Phytosanitary (SPS) Measures (please also turn to the same-named section above): Plant Health Department,
Secretary of Agricultural Protection, Ministry of Agriculture, Livestock and Food Supply = Departamento de Sanidade Vegetal
(DSV), Secretaria de Defesa Agropecuária (SDA), Ministério da Agricultura, Pecuária e Abastecimento (MAPA), Esplanada dos
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Ministérios, Bloco D, Anexo B, Sala 303-B, BR-70043900 Brasilia, phone number: +55 61 32182675, fax number: +55 61
32243874.
Seeds and seedlings fall under risk category 4 (please see the chapter on Plants and Plant Products above for details of the
Brazilian risk classification of plants and plant products). The importation thereof is thus to be conducted in three steps. The first
step consists in the application for an import permit at the local unit of the MAPA of the federal state where the importer is
located. As second step, a customs release certificate must be applied for at the local unit of the MAPA of the federal state of
entry or directly at the customs office of entry. For this purpose, a certificate for seeds from the country of provenance or origin
and a Phytosanitary Certificate issued in the country of export are to be submitted, amongst others. Finally, as third step, an
application for an Inspection of Agricultural Products is required, as well as the import licence (if applicable), the Commercial
Invoice, the tax invoice, the Cargo Manifest and the certificate of depositary (as applicable). In case of positive results, an
inspection certificate ("termo de fiscalização") is issued.
Phytosanitary Certificate
Please see the section on Marking and Labelling Requirements below for the information to be provided on the labels of
seeds and to the section on Prohibited Goods regarding propagative material containing soil as well as harmful live insects,
pests, bacteria and fungi.
Endangered Species
The importation of consignments containing wild animals or endangered species of plants or products thereof which are subject
to the Convention on International Trade in Endangered Species of Wild Flora and Fauna (CITES), also referred to as
Washington Convention, is only possible with a permit issued by the Brazilian Institute for Environment and Renewable Natural
Resources (IBAMA) assigned to the Ministry of the Environment (MMA). For more information, please refer to the documents:
Foodstuffs
The importation of certain products falling under this category is subject to import restrictions. While edible products of animal
and plant origin are generally covered in the sections above, the Ministry of Agriculture, Livestock and Food Supply (MAPA)
also demands certificates and import permits for beverages:
Certificate of Maturation
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Combined Certificate of Origin and Analysis for Beverages and Fermented Acids
Combined Certificate of Origin and Analysis for Beverages Derived from Grapes
These documents are to be presented to the relevant authorities according to the following procedure:
Before any actual importation of beverages in general may be initiated, the importer is to complete his Registration of Importers
of Beverages. A Combined Certificate of Origin and Analysis for Beverages and Fermented Acids or, respectively, a Combined
Certificate of Origin and Analysis for Beverages Derived from Grapes is to be presented accompanied by, amongst other
documentation, a document fixing the terms of responsibility for the imported goods. On the basis of this and further
documentation, the Permit to Import Wine will be processed, as applicable. In case of specific beverages, a Certificate of
Maturation may be required. Only upon the complete submission of all required information and once all required checks have
been accomplished, the authorities will issue an Import Inspection Certificate for Beverages.
Please note that importers of specific alcoholic beverages (e.g. vermouth and other wine of fresh grapes flavoured with plants
or aromatic substances, other fermented beverages, whiskies, rum, gin and vodka) must additionally be inscribed in the special
register maintained by the Special Secretariat of Federal Revenue of Brazil (RFB). The application for registration must be
submitted in form of a digital dossier to a local unit of the RFB. This registration is a prerequisite for obtaining the mandatory
control stamps, which are to be affixed to the mentioned beverages. Importers of wine are exempt from these requirements.
For information on the labelling requirements for foodstuffs and beverages, please turn to the chapter on Marking and
Labelling Requirements further below.
In the scope of the Cartagena Protocol, the Biosafety Clearing House (BCH) is a platform for the exchange of scientific,
technical, environmental and legal information on, and experience with, modified organisms. It also assists parties to implement
the Protocol and has local branches in various countries. Further information may be obtained from the Biosafety Clearing
House (BCH), 413, St. Jacques Street, Suite 800, CA-Montreal, Quebec, H2Y1N9, phone number: +1 514 2882220, fax
number: +1 514 2886588.
The national focal point in Brazil may be contacted as follows: Department for the Environment and Special Topics, Ministry of
Foreign Affairs = Departamento de Meio Ambiente e Temas Especiais, Ministerio das Relações Exteriores, Palácio Itamaraty,
Esplanada dos Ministérios, Bloco H, BR-70170900 Brasilia, phone numbers: +55 61 20308097, 20308447, 20308448,
20308452, 20309203, fax number: +55 61 20308446.
For information on procedures applicable to narcotic and psychotropic substances and their precursors, please refer to the
section below entitled Narcotics and Psychotropic Substances for the corresponding information.
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Importers of veterinary medicinal products must apply for a Permit to Import Veterinary Products and Supplies. Depending on
the actual product to be imported, a Registration of Importers of Agricultural Products as well as an Inspection of Agricultural
Products may be required. Please also consult the section entitled Live Animals, Products of Animal Origin and
Agricultural Products for more specific information on this issue.
Please refer to the documents listed below for details of the procedures described in the context of import requirements for
medicines intended for human use:
Operating Permit for Trade in Medicines, Medical Products and Related Goods
Registration of Medicines.
Operating Permit for Trade in Medicines, Medical Products and Related Goods.
Cosmetics
For the importation of cosmetics into Brazil, importers must be authorised by the National Health Surveillance Agency (ANVISA)
assigned to the Ministry of Health. Moreover, a registration of the cosmetic products with said authority is mandatory. Shipments
must be accompanied by a Free Sale Certificate. For further information, please see the corresponding documents:
Operating Permit for Trade in Medicines, Medical Products and Related Goods
Registration of Cosmetics.
In case a company is seeking to export chemicals which are covered by the Convention (i.e. the pesticides and industrial
chemicals listed in Annex III of the Convention) or which are subject to national regulatory action (i.e. bans or severe restrictions
in the importing country's own territory), an export notification must be sent to the Designated National Authority (DNA) of the
importing country nominated to this effect in order to obtain prior consent, and a safety data sheet may be required as well. For
further information, the following documents may be consulted:
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In addition to the Rotterdam Convention, Brazil is also party to the Stockholm Convention on Persistent Organic Pollutants (also
referred to as the POP Convention), a treaty designed to curb and eventually abolish the production, use and trade of toxic,
long-lasting chemicals by requiring its signatories to take measures to eliminate or restrict the production and use of POPs and
to minimise any possible unintentional releases of such substances into the environment. Exemptions, i.e. the continued use
and/or production of one or more chemicals covered by the treaty for a certain period of time, may be applied for by the
member states. Furthermore, amendments to the treaty (lastly done so in 2009 with the addition of nine more chemicals to the
original list of twelve chemicals) are subject to the approval and ratification of each signatory state, thereby allowing the country
time to implement the measures required to adhere to the new stipulations. As a consequence, imports and exports of the
chemicals covered by the Stockholm Convention may be subject to prohibitions or severe restrictions. Importers are also
advised to contact the responsible authority for issues of nature protection, i.e. the Official Contact Point (OCP), which is the
Division of Climate Change, Ozone and Chemical Safety (DCLIMA), Ministry of External Relations (MRE), Esplanada dos
Ministérios, bloco H Anexo II, Sala 204, BR-70170900 Brasilia, phone number: +55 61 20309289, fax number: +55 61
20309288.
On 8 August 2017, Brazil ratified the Minamata Convention on Mercury, a global treaty to protect human health and the
environment from the adverse effects of mercury. The Convention intends to ensure that exports of mercury may only take
place with the prior consent of the importing country and for the purpose of environmentally sound interim storage or an allowed
use. Such consent must also be sought in the case of export transactions from a member state to any country which is not a
party of the Convention. Forms for the provision of written consent by a party or a non-party to the import of mercury are both
made available by the Convention in different languages.
In addition, the phase-out of mercury-added products has been agreed upon. Therefore, by 2020, Brazil will ban the production,
exportation and importation of numerous mercury-containing products, e.g. dry cell batteries, switches and relays, certain types
of fluorescent lamps, cosmetics, pesticides as well as designated non-electronic measuring devices (e.g. thermometers and
blood pressure monitors). Parties may apply for the registration of exemptions from the stipulated phase-out dates for one or
more products or processes listed in Annex A or B of the Convention if their use or import is deemed essential. Unless a shorter
period is indicated in the respective register by a party, exemptions usually expire five years after the relevant phase-out date
and may be extended only once per product upon request.
Next to these internationally agreed obligations in the field of hazardous chemicals and pesticides, a national legal framework
regulating the importability of pesticides into the country exists. The related legal stipulations provide for the necessity to apply
for a Permit to Import Pesticides at the Ministry of Agriculture, Livestock and Food Supply (MAPA) in order to initiate the
prescribed importation procedures. Please see the quoted document for details.
Brazil is also a signatory to the Montreal Protocol on Substances that Deplete the Ozone Layer, in the scope of which the
country is in the process of phasing-out the trade in and use of ozone-depleting substances (ODS) in compliance with a system
of fixed quotas. Trade in chlorofluorocarbons (CFCs) is prohibited since 2010. A phase-out plan for hydrochlorofluorocarbons
(HCFCs) is being enforced since 1 January 2013; the ultimate prohibition of such substances is aimed at in 2040.
For substances which are not yet prohibited from importation into the country, an Authorisation to Import Ozone-Depleting
Substances is required.
Radioactive Substances
Radioactive substances as well as equipment emitting ionising radiation must not be imported without a corresponding import
licence issued by the National Commission for Nuclear Energy (CNEN) under the Ministry of Science, Technology, Innovations
and Communications (MCTIC). The related procedures are described in the following documents:
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Products (R-105). Moreover, importers must obtain an import licence from the Ministry of Internal Administration (MAI) or an
import certificate issued by the Brazilian Army. Please refer to the following documents for more details:
Petrol Products
Importers of petrol and oil products must be registered with the National Agency for Petroleum, Natural Gas and Biofuels
(ANP). This Agency is also responsible for the registration of lubricating oils and additives and lubricating grease. For details,
please refer to the following documents:
Diamonds
Importers of rough diamonds must obtain an import permit from the National Mining Agency (ANM) assigned to the Ministry of
Mines and Energy (MME). Furthermore, a certificate confirming that the rough diamonds to be imported have been handled in
accordance with the provisions of the Kimberley Process Certification Scheme (KPCS) is required. Please see the following
documents for further information:
Textiles
Goods falling under the customs tariff chapters 61 and 62 of the Harmonized System (HS) are cleared through the red channel
(verification of tariff classification and weight of the consignment) and the grey channel (sample-taking and analysis). This
means that, once the Customs Import Declaration for the respective goods has been received by the customs official,
documentary as well as physical inspections of the goods are initiated and samples are taken. Importers are consequently
confronted with delays for the customs clearance of textiles and articles of clothing. These are reported to amount to up to 90
days, prolongable by another 90 days if additional time is required for inspection. By subjecting the goods to such strict controls,
the customs authorities seek to prevent the false declaration of the quantity and quality of goods to be entered into Brazil, such
as the admission of false brand products.
Telecommunications Equipment
In order to be granted customs clearance and market access in Brazil, telecommunications equipment is to be certified by a
certification or inspection body accredited by the Brazilian authority for standards, i.e. the Directorate of Conformity Assessment
of the National Institute of Metrology, Quality and Technology (INMETRO). The form of accepted proof of this certification is the
Certificate of Conformity. The related conformity assessment procedures may be facilitated by the submission of a Declaration
of Conformity prepared by the manufacturer of the goods.
The responsible authority for the supervision of the applicable standards for telecommunications equipment is the National
Telecommunications Agency (ANATEL).
Please refer to the quoted documents for further details and to the section entitled Standardisation in this overview for the
standards applied on other goods.
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Standardisation
The competent authority for the supervision and coordination of national standards is the National Institute of Metrology, Quality
and Technology (INMETRO) under the Ministry of Economy.
According to the Brazilian Conformity Evaluation System (SBAC), some products, e.g. toys, require a Certificate of
Conformity for importation. The process of obtaining such certification may be facilitated by the submission of a Declaration of
Conformity from the manufacturer to the certifying inspection body. The relevant procedures are described in the quoted
documents. For further information, please contact the National Institute of Metrology, Quality and Technology = Instituto
Nacional de Metrologia, Qualidade e Tecnologia (INMETRO), Rua Santa Alexandrina 416, BR-20261232 Rio de Janeiro, phone
numbers: +55 21 25632801, 25632864.
Prior to the actual importation of motor vehicles, a Confirmation of Homologation of Motor Vehicles is to be obtained from the
Brazilian Institute for Environment and Renewable Natural Resources (IBAMA). Please refer to the quoted document for the
corresponding details.
The applicable requirements for the standards compliance of Telecommunications Equipment are described in the quoted
section above.
Used Goods
Generally, the requirements for the importability of used products may differ from those applied on the same goods if imported
in new condition. For information on import bans of certain used goods, please refer to the section on Prohibited Goods.
The legal basis for the importation of used goods is provided by Ordinance DECEX No. 08 of 13 May 1991 and Ordinance
SECEX No. 23 of 14 July 2011 (as amended). According to these legal bases, the list of goods importable in used condition
primarily comprises those mentioned below:
machinery, equipment, instruments, apparatus, tools and matrices as well as containers intended for cargo purposes, provided that they are not produced in the country and may
not be substituted by other ones currently produced in Brazil
machinery, equipment, instruments and apparatus intended for reconstruction purposes, if they reach a technological condition not available in Brazil and if they have the same
guarantee as new similar products and integrate inputs of local production
reconditioned parts, pieces and accessories intended for the maintenance of machinery and equipment, if the reconditioning has been conducted by the manufacturer or an
accredited company and if the products to be imported have the same guarantee as new products and are not produced in the country
transference of industrial units, production lines and cells related to projects approved by the Secretariat of Foreign Trade (SECEX)
cultural goods
antique vehicles (e.g. tractors, motor vehicles intended for the transport of ten or more persons or for the transport of goods and special purpose motor vehicles) older than 30
years intended for cultural and collection purposes, including parts and accessories intended for their maintenance and restoration
fishing vessels
reconditioned parts, pieces and accessories intended for the maintenance of information technology and telecommunications products, if the reconditioning has been conducted
by the manufacturer or an accredited company
used parts, pieces and accessories intended for the repair or maintenance of information technology and telecommunications products in Brazil, if the reconditioning is conducted
by the manufacturer of the finished product or an accredited company
machinery, equipment, vehicles, apparatus or instruments as well as their parts, pieces and components of national production which have been exported for contracted work
abroad and are returned to Brazil
machinery, equipment, instruments, apparatus, tools, matrices and containers as well as their components, pieces and accessories imported under the procedure of integrated
drawback under suspension
specific matrices related to an industrialisation project in Brazil and tools manufactured to order and for a specific purpose.
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The importation of used goods is subject to non-automatic import licensing prior to the embarkation of the commodities in the
country of export. However, there are certain exemptions from this requirement, e.g. for aircraft. Please see the document
entitled Non-Automatic Import Licence as well as the chapter on Import Licensing for further details.
Waste
Brazil is a party to the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and Their
Disposal. In accordance with the provisions of this Convention, shipments of hazardous waste intended for recovery operations
or disposal require a notification submitted to the Brazilian Institute for Environment and Renewable Natural Resources
(IBAMA) under the Ministry of the Environment (MMA) prior to the transportation and are to be accompanied by a movement
document. Furthermore, the importation of certain hazardous wastes is prohibited. For more information on the procedures,
please refer to the corresponding documents:
Designated non-hazardous waste may be eligible for importation into Brazil, e.g. slags from precious metals processing for
further refining. The Organisation for Economic Co-operation and Development (OECD) provides a guideline for the
international trade in said goods by virtue of its Decision of the Council concerning the Control of Transboundary Movements of
Wastes Destined for Recovery Operations. A corresponding OECD guidance manual has been developed.
The OECD control system is based on two types of control procedures (please note that waste exported outside the OECD
area, whether for recovery or final disposal, does not benefit from this control system):
green control procedure: for wastes that present a low risk for human health and the environment and, therefore, are not subject to any other controls than those normally applied
in commercial transactions
amber control procedure: for wastes presenting sufficient risk to justify their control accordingly.
By way of example, the European Union (EU) approved the aforementioned Decision. Therefore, consignments of waste being
exported from the EU are subject to the basic Regulation (EC) No 1013/2006 on shipments of waste and its amendments. In
order to assist countries outside the OECD to ensure that these import only the types of waste they agree to, exports of non-
hazardous waste for recovery purposes to such countries are regulated. Potential destination countries therefor provide
information on permissible waste by completing respective questionnaires for non-hazardous waste and for mixtures of waste.
Brazil has already replied to said questionnaires and various types of waste have consequently been classified as follows:
waste subject to prior written notification and consent as described in Article 35 of Regulation (EC) No 1013/2006 (e.g. the abovementioned slags from precious metals
processing for further refining); to be controlled by the customs authorities of the EU Member State from which the waste is exported
waste not subject to specific control measures in Brazil (e.g. scrap plastic of non-halogenated polymers and copolymers)
control procedures, which are to be followed in Brazil under its applicable national laws (e.g. nickel and zinc scrap); to be controlled by the Brazilian customs authorities at the
time of the importation of the waste into Brazil.
The applicable legal basis is Regulation (EC) No 1418/2007 (as amended). As the waste codes set out by the Basel
Convention and the Harmonized System (HS) Codes may only be compared on a rough level, the following Brazilian authority
should be consulted prior to the importation of any non-hazardous waste: Brazilian Institute for Environment and Renewable
Natural Resources assigned to the Ministry of Environment = Instituto Brasileiro do Meio Ambiente e dos Recursos Naturais
Renováveis (IBAMA) do Ministério do Meio Ambiente (MMA), SCEN Trecho 2, Edifício Sede, Cx. Postal No. 9566,
BR-70818900 Brasilia, phone number: +55 61 33161212.
More information, the applicable legal stipulations and completed questionnaires may be found on the following website:
http://ec.europa.eu/trade/import-and-export-rules/export-from-eu/waste-shipment.
Commercial Samples
Samples without commercial value may be imported free of customs duties into Brazil. According to Decree No. 6.759 of 5
February 2009, products are defined as samples without commercial value if they are imported in a quantity which is strictly
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Harmonized System
As a multipurpose international product nomenclature, the Harmonized Commodity Description and Coding System (HS),
commonly referred to as Harmonized System, constitutes a universal economic language and code for goods.
Developed and continuously enhanced by the World Customs Organization (WCO), the HS consists of over 1,200 four-digit
headings grouped in 97 chapters, which are arranged into 21 sections. Most of the headings are further subdivided into five-
digit or six-digit subheadings. In total, the Harmonized System comprises about 5,000 commodity groups, each identified by a
six-digit code (HS Code). HS Codes are identical in different countries, provided the latter apply the same version of the HS.
The classification of goods into HS-based nomenclatures generally follows the same principles. In trade practice, however, it
may not be necessarily the same.
In an interval of usually five years, the Harmonized System is kept up to date reflecting changes in technology or in international
trade volumes. The last amendment became effective in 2017 when the sixth revision of the HS replaced the former version
referred to as HS 2012. However, the actual implementation of the current HS version (HS 2017) as well as the adaptation of
related non-tariff measures may take place at varying points in time in different countries.
Not only in view of the periodic amendments of the HS, commodity codes and related descriptions included in commercial
documents should always contain a reference to the nomenclature basis, e.g. HS 2012 or HS 2017 (please refer to the section
on the Harmonized System above). In case the commodity codes indicated go beyond the six-digit level of the HS and refer to
the tariff nomenclature of the destination country, these codes should be adjusted with the importer.
Exporters should bear in mind that besides officially required documentation, additional necessities may result from contractual
agreements with the importer. If a sales contract or a letter of credit (L/C) stipulates that particular documents are to be supplied
by the exporter, their provision constitutes an obligation, regardless of official requirements. Moreover, customs or further
authorities may request additional documentation if they consider the information given in the customary documentation as
insufficient or doubtable. Besides necessities of the authorities, importers or forwarders, requirements for import documentation
are also influenced by trade practice.
Incoterms®
Responsibilities of sellers and buyers concerning the delivery of goods under international sales contracts are frequently
defined by the so-called Incoterms®. These International Commercial Terms, created by the International Chamber of
Commerce (ICC), constitute authoritative rules for the allotment of costs and risks to the parties of sales contracts. Because of
the determination of how costs are allocated to the parties, Incoterms® are also used for purposes of customs valuation. It is
generally advisable to refer to a specific edition (e.g. Incoterms® 2010) when Incoterms® are included into contracts or trade
documents. If no explicit reference to a version is made, the use of the current 2010 edition will be assumed.
The current edition of the Incoterms® 2010 stipulates the following eleven rules:
Ex Works: EXW
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If the DDP rule is used, the exporter is responsible for the customs and import clearance of the goods. The importer, however,
is required to assist the exporter in obtaining official authorisations where applicable. Therefore, this term should not be used if
the exporter is not in the position to either directly or indirectly arrange for the clearance of the commodities.
The country of origin labelling on the merchandise and/or its packaging should correspond to the origin stated on the
commercial documents. It should be borne in mind that any indication of a country on the commodity itself may be valued as a
declaration of origin. In case of any doubts, it is advisable to contact the importer.
Consumer Products
According to Law No. 8078 of 1990, which sets out provisions for consumer protection, products to be offered to consumers in
Brazil must bear correct, clear and precise information in Portuguese on at least the following details (if and as applicable):
characteristics
quality
quantity
composition
price
guarantee
date of expiry
origin
In case of refrigerated products to be offered to consumers, the above-mentioned details must be engraved in an indelible
manner.
National Register of Legal Persons (CNPJ) or National Register of Natural Persons (CPF) number, as applicable
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date of manufacture
date of expiry
lot identification
country of origin
Labels of foodstuffs which contain lactose must also indicate the presence of this substance. If the original lactose content has
been modified, the remaining lactose content must be declared.
Prepackaged Foodstuffs
Prepackaged foodstuffs must bear a nutritional label in accordance with Resolution RDC No. 360 of 2003. The labelling must
declare the total energy value and the content of the following nutrients:
carbohydrates
proteins
total fats
saturated fats
trans fats
dietary fibre
sodium.
Complementary information on the nutritional properties of the products, e.g. on the exact type of fatty acids or cholesterol or on
contained vitamines and minerals, and on the country of origin may optionally be declared as well.
commercial brand
ingredients
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lot number
shelf life
Medicines
The labelling and packaging standards for medicines are established, monitored and revised by the National Health
Surveillance Agency (ANVISA). By virtue of Resolution No. 71 of 22 December 2009 of the Board of Directors, the ANVISA
enforces a number of labelling requirements applicable to medicines registered and marketed in Brazil. The ANVISA generally
differentiates between labels attached to or printed on the primary packaging on the one hand and on the secondary packaging
on the other hand:
generic name of each active ingredient using the common Brazilian denomination scheme
mode of ingestion
pharmaceutical form
restrictions for the use by defined age groups using the wording "USO ADULTO" or "USO ADULTO E PEDIATRICO ACIMA DE ___"
qualitative composition of the product in conformity with the common Brazilian denomination scheme
storage conditions including permissible ranges of temperature in compliance with the product-specific stability studies
name and address of the company holding the Registration of Medicines in Brazil
name and complete address of the manufacturer preceded by the words "Fabricado por"
name and complete address of the company responsible for the packaging of the product, if diverging
National Register of Legal Persons (CNPJ) number of the holder of the Registration of Medicines
name of the technically responsible person, company's registration number with the Regional Pharmacy Council
Registration of Medicines number preceded by the abbreviation "MS" as published in the Official Journal.
generic name of each active ingredient using the common Brazilian denomination scheme
mode of ingestion
Seeds
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In general, seeds to be sold in Brazil must bear a label in Portuguese which contains the following information:
lot number
national standard on the germination or on viable seeds, in percentage terms (as applicable)
harvest
In case of imported seeds, the following information must be written on the label in addition to the above-mentioned details:
country of origin.
Imported seeds may be exempted from the above-mentioned general labelling requirements during the transport from the point
of entry to the importer's establishment and during warehousing, if not otherwise stipulated in complementary norms.
If the seeds have been coated or treated, the following details are to be presented on the label:
used dose.
Moreover, in case of seeds coated with pesticides for seeds treatment, the active ingredient and its concentration is to be
indicated. Labels of seeds treated with pesticides for seeds treatment or other substances harmful for human or animal health
must present the following information:
preventive measures
Seed consignments must be packaged in new packages of first use and must be free from soil, plant residues and seeds of
quarantine weeds.
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The labels of fertilisers and of agricultural inoculants and correctives must be in Portuguese or be accompanied by a
Portuguese translation. They must bear the following details:
National Register of Legal Persons (CNPJ) or National Register of Natural Persons (CPF) number of the manufacturer or importer
commercial brand
indication "Indústria Brasileira" (Brazilian industry) or "Produto Importado" (imported product), as applicable
Registration Fertilisers number or, if applicable, authorisation number or the indication "Produzido sob encomenda" (produced on demand)
information on the storage, limitations of use and, if applicable, instructions for the use and transport
microorganisms, strains or plants for which the products are intended, in case of inoculants
type of additives and quantity (in percentage), in case of products containing additives.
Due to the legal implementation of the ISPM No. 15, information on the wood packaging may be required to be included in the
accompanying freight documents.
Upon arrival, an Inspection of Wood Packaging Material is to be conducted by the Ministry of Agriculture, Livestock and Food
Supply (MAPA) in order to examine the phytosanitary condition of the WPM and assess the conformity of the IPPC mark or the
corresponding certificate. Please refer to the quoted document for detailed procedural information.
If the packaging consists of or contains hay and straw, a Phytosanitary Certificate is required for the importation of these
materials.
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