Vértice Internacional - Brazilian Regulatory Agencies

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.

[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.