Regulatory Agencies[1]
[2]
or Consenting Bodies are government agents with the capacity and power to authorize,
or not, the trade of some products. The role played by these Agencies works for
both national and international markets – applying distinct rules for each one
– by controlling and inspecting products and companies. The main purpose of the
Agencies can be summed up into guaranteeing the security of the country and the
population, and they do so by standardizing technical requirements, requiring levels
of quality and demanding compliance policies.
Each product class is the responsibility of and managed by one of these
agencies. Thus, if a Brazilian company wants to export or import a product, it
must check if there are any specific requirement regarding foreign trade.
Specific requirements may include product and company registration, product and
company inspection, certifications, Good Manufacturing Practices (GMP), Import
License, among others. The consent will be granted only after the company
fulfills all requirements.
Therefore, for cases in which there are specific requirements, there is
the participation of both the Regulatory Agency and Customs in the export and
import releasing processes. For some products, however, there are no specific
requirements from the Regulatory Agency, which means that the product will be
inspected only by Customs, when leaving or arriving the country.
A foreign company that wants to negotiate with a Brazilian company must
be aware of the Brazilian Regulatory Agencies requirements. If the foreign
company wants to export to Brazil, they must know if its factory and product
need to be inspected or registered, as well as know if they need any kind of
certification or license. On the other hand, if the foreign company wants to
import from Brazil, it must consult the local legislation, from its country,
but it is central to know if the Brazilian company is properly authorized to
export. So, Brazilian Regulatory Agencies is a more important subject for
companies that want to export to Brazil than for companies that want to import
from Brazil. Therefore, from here on, we will consider the export process to
Brazil.
From a more technical and practical point of view, Regulatory Agencies
can play their role basically in two moments: a) in the certification and
registration phase (always before shipment); b) in the authorization (Import
License) phase (before or after shipment). For some cases, both are necessary.
So, before exporting your product to Brazil, you must know well the procedures
and know which one is applied to your product and company[3].
The first moment (certification and registration phase) is related to check the
product and the company, and if they comply with the requirements[4].
The second moment (authorization) is related to inform the Regulatory Agency
that the product will be or is being imported[5].
Brazil has several Regulatory
Agencies. The most famous are Anatel, Anvisa, Ibama, Inmetro and Mapa[6].
Usually, products covered by these Agencies need to go through the two phases
mentioned above.
ANVISA
– Brazilian Health
Regulatory Agency
The Brazilian Health Regulatory Agency (Anvisa) is an autarchy linked to
the Ministry of Health, part of the Brazilian National Health System (SUS) as
the coordinator of the Brazilian Health Regulatory System (SNVS), present
throughout the national territory. Anvisa’s role it to promote the protection
of the population’s health by executing sanitary control of the production,
marketing and use of products and services subject to health regulation,
including related environments, processes, ingredients, and technologies, as
well as the control in ports, airports and borders (BRAZIL, 2021).
Exporting products regulated by Anvisa to
Brazil might include the need for specific pre-market authorizations issued by
regulatory bodies in Brazil. Also, for some classes of products, manufacturers might have to be
certified by Anvisa, a process which might include inspections at the place of
origin – The requirements vary depending on the product. Products regulated by
Anvisa are subjected to approval at borders when entering Brazil and might be
subjected to physical inspection. The main regulation about border control to
which products regulated by Anvisa are subjected to is the Resolution RDC
81/2008 (available only in Portuguese) (BRAZIL, 2021). There are other
product-specific norms that must be observed by companies that wish to export
to Brazil.
Some
products classes regulated by ANVISA: Cosmetics; Drugs; Food; Medical Device;
Pesticides; Pharmaceutical Ingredients; Sanitizing Products; Smoking Products;
among others – Within each category, each product has its own regulation.
ANATEL
– National Telecommunications
Agency
The National Telecommunications Agency (Anatel) is an autarchy linked to
the Ministry of Communications. It is administratively independent and
financially autonomous. Anatel is responsible for adopting the necessary
measures to serve the public interest and for the development of Brazilian
telecommunications. It is up to Anatel to implement and control the national
telecommunications policy; issue or recognize product certification, observing
the standards and norms established by it; represent Brazil in international
telecommunications organizations; among others. According to Brazilian regulations,
telecommunications products to be sold and used in Brazil, must have a
Certificate of Conformity issued by a Designated Certification Body (OCD), indicating
that they comply with Brazilian regulatory requirements (BRAZIL, 2021). This certificate must also be approved/homologated
by Anatel.
Exporting products regulated by Anatel to
Brazil might include the need for specific pre-market authorizations issued by
regulatory bodies in Brazil. The requirements vary depending on the product. Products regulated by Anatel
are subjected to approval at borders when entering Brazil and might be
subjected to physical inspection.
Some
products classes regulated by ANATEL: Wireless technology; Optical fiber; Lithium
Batteries and Cell Phone Chargers; Mobile telephony, fixed-line telephony,
broadband and cable-TV; antennas, digital television transmitters and radars;
among others – Within each category, each product has its own regulation.
IBAMA
– Brazilian
Institute of the Environment and Renewable Natural Resources
The Brazilian Institute of the Environment and Renewable Natural
Resources (IBAMA) is an autarchy linked to the Ministry of the Environment. It
is administratively and financially autonomous. It is up to IBAMA to execute
actions of national environmental policies related to environmental licensing,
environmental quality control, authorization to use natural resources and
environmental inspection, as well as the environmental monitoring and control (BRAZIL,
2021).
Exporting products regulated by IBAMA to Brazil
might include the need for specific pre-market authorizations issued by
regulatory bodies in Brazil. The requirements vary depending on the product. Products regulated by IBAMA
are subjected to approval at borders when entering Brazil and might be
subjected to physical inspection.
Some
products classes regulated by IBAMA: Flora and wood; Pesticides; Chemical and
biological; among others – Within each category, each product has its own
regulation.
INMETRO – The National Institute of
Metrology, Standardization and Industrial Quality
The National Institute of Metrology, Standardization and Industrial
Quality (INMETRO) is an autarchy linked to the Ministry of Economy. Inmetro is
responsible for the Product Conformity Assessment program in Brazil. It is up
to Inmetro to implement national metrology and quality policies, stimulate the
use of quality management techniques in Brazilian companies, plan and execute
the activities of Accreditation of Calibration and Testing Laboratories, among
others (BRAZIL, 2021).
Exporting products regulated by INMETRO to
Brazil might include the need for specific pre-market authorizations issued by
regulatory bodies in Brazil. The requirements vary depending on the product. Products regulated by INMETRO
are subjected to approval at borders when entering Brazil and might be
subjected to physical inspection.
Some
products classes regulated by INMETRO: Toys; Home appliances; Electrical appliances;
Safety equipment; Automotive components; among others – Within each category,
each product has its own regulation.
MAPA – Ministry of Agriculture,
Livestock and Food Supply
The Ministry of Agriculture, Livestock and Food Supply (MAPA) is linked
to the Brazilian Government. It is responsible for the management of public
policies to encourage agriculture, for the promotion of agribusiness and for
the regulation and standardization of services linked to the sector (BRAZIL, 2021).
Exporting products regulated by MAPA to Brazil
might include the need for specific pre-market authorizations issued by
regulatory bodies in Brazil. The requirements vary depending on the product. Products regulated by MAPA
are subjected to approval at borders when entering Brazil and might be
subjected to physical inspection.
Some
products classes regulated by MAPA: Animal Origin Products; Plant Origin Products; Beverage; Live animals;
among others – Within each category, each product has its own regulation.
Written
by Eduardo Vidal
LinkedIn:
https://www.linkedin.com/in/eduardomelovidal/
REFERENCES:
BRAZIL. Law 200/1967. Available
in: <www.planalto.gov.br/CCIVIL_03/_Ato2011-2014/2014/Lei/L13043.htm>
ANATEL. Available in:
<https://www.gov.br/anatel/pt-br>
ANVISA. Available in:
<https://www.gov.br/anvisa/pt-br/english>
IBAMA. Available in:
<https://www.gov.br/ibama/pt-br>
INMETRO. Available in:
<https://www.gov.br/inmetro/pt-br>
MAPA. Available in:
< https://www.gov.br/agricultura/pt-br>
[1] In Brazil, a Regulatory Agency is
usually called “Órgão Anuente”. It can also be referred as “Órgão Regulador” or
“Agência Reguladora”.
[2] Some of these Agencies are
autarchies, which, under Brazilian administrative law, means “an autonomous
service, created by law, with its own legal personality, assets and revenue to
perform typical Public Administration activities, which require, for its best
functioning, a decentralized administrative and financial management.” (BRASIL,
1967).
[3] If a company does not know what the
requirements are, it should consult the importer or a Brazilian consultancy
company.
[4] Usually, the importer is the one
who makes the registration request with information provided by the exporter. The
exporter may also host the registration within a Brazilian hosting company.
[5] There are two kinds of Import
License, depending on the product. For some products, the Import License must
be required before the shipment. In other cases, the Import License can be
required before shipment or between the shipment and the arrival.
[6] There are also ANEEL, ANCINE,
COMEXE, DECEX, DPF, DNPM, ANP, CNPq, EBC, MCTIC and SUFRAMA.
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