Describes standards, identifies the national standards, accreditation bodies, and lists the national testing organization(s) and conformity assessment bodies.
INMETRO is the main national accreditation body and is in charge of implementing the national policies regarding quality and metrology established by CONMETRO, which oversees INMETRO’s activities. INMETRO is responsible for certification of products, services, licensing, and testing labs, among other duties.
The Brazilian Association of Technical Standards (ABNT) is the recognized standards organization which establishes and manages marks of conformity with standards applied in voluntary or compulsory product certification schemes. ABNT is an accredited registration body to certify quality systems, environmental management systems and several products. They develop national standards, and reference ISO and IEC standards, and sometimes, U.S. developed international standards. Several U.S. Standards Development Organizations have MOUs with ABNT for cooperation.
When the need for standardization of a given topic arises, ABNT refers the matter to the responsible Technical Committee, where it will be considered by the various sectors involved. Once the draft standard has been prepared, it is then submitted for national consultation. In this process, the Draft Standard, prepared by a Study Committee representing the stakeholders and sectors involved, is submitted publicly for consideration. During this period, any interested party may express, without any burden, recommendations to the Study Group to authorize the approval of the text as presented; approve of the text with suggestions; or its non-approval, though the interested party must present the technical objections and justification.
INMETRO’s New Conformity Assessment Policy
The Conformity Assessment Board (DCONF), INMETRO’s body responsible for macro conformity assessment policy, designed a new regulatory model which was launched in February 2022. The purpose of this model is to improve regulatory performance, reduce administrative burdens, encourage innovation and the competitiveness of the productive sector, and align the country with the best international practices in product regulation. The initiative supports the federal government’s directive to improve the regulatory environment in Brazil in order to promote economic development.
The regulatory model has two objectives. The first is to expand the effectiveness and efficiency of INMETRO regulations by improving targeting, coverage, and compliance. Approximately 40% of products, previously subjected to INMETRO regulation were removed from INMETRO regulations. The second is to reduce adverse effects of regulations on economic activity.
Reduction of red tape, simplification of regulatory management, and optimization of resources are the main principles that guide the model. INMETRO has looked to international best practices to achieve these objectives.
The regulatory model has three pillars that will allow it to achieve its objectives. The first is the introduction of general regulations and essential requirements, which will help to increase regulatory coverage under INMETRO’s legal scope and reduce the prescriptiveness of specific rules. The second pillar emphasizes solving regulatory problems by strengthening monitoring activities and planning and prioritizing regulatory actions based on identified problems. The third pillar comprises increasing the responsibility of suppliers for compliance.
At the base of the three pillars is the general principle of flexibility. That principle relates to the idea of efficiency and proportionality of regulatory actions. The actions used must be those strictly necessary for the resolution of the regulatory problems and resources should be allocated in order to maximize the effectiveness of the regulation.
Testing, Inspection, and Certification
Conformity assessment includes all activities needed to demonstrate compliance with specified requirements relating to a technical regulation or voluntary standard. In Brazil, the conformity assessment system follows ISO guidelines. Conformity assessment includes test and calibration laboratories, product certification bodies, accreditation bodies, inspection and verification units, quality system registrars, and others.
Conformity assessment can be voluntary or mandatory, done through a legal instrument to protect the consumer on issues related to life, health and environment. Interested U.S. parties can be accredited by INMETRO to perform conformity assessment activities.
For regulated products, the relevant government agency generally requires that entities engaged in product testing and mandatory certification be accredited by INMETRO. Generally, testing must be performed in-country, unless the necessary capability does not exist in Brazil. INMETRO is currently engaged in a regulatory reform process. Its stated reform goals include: improve regulatory performance; reduce administrative effort; stimulate innovation and competitiveness of the productive sector; and better align Brazilian regulations with international best practices. INMETRO has indicated it will look to reduce extensive third-party local testing and certification requirements based on a risk analysis under the new model, once implemented.
INMETRO is a signatory to the Mutual Recognition Arrangement (MRA) of the International Laboratory Accreditation Cooperation (ILAC), which can facilitate acceptance of test results from U.S. laboratories that are accredited by U.S. organizations and are also signatories.
There is still no legal mandate to retest non-regulated products that have been approved in their country of origin. For non-regulated products, some U.S. marks and product certification may be accepted. As with all voluntary standards, any certification that may be required in non-regulated sectors is a contractual matter to be decided between buyer and seller. Market forces and preferences sometimes make a specific certification, while not officially required, needed due to market preferences.
To facilitate U.S. product acceptance in Brazil by recognizing existing certifications, agreements between U.S. and local certifiers/testing houses are encouraged. There is no impediment to the establishment of U.S. certification organizations in Brazil. If your product has been certified in the U.S. or Europe, it may not need to be recertified (see ILAC MRA above). If your product is not certified, please refer to the mandatory product certification process.
A search engine of certified products, both mandatory and voluntary, in Brazil is available. The General Coordination for Accreditation (CGCRE) of INMETRO is responsible for accrediting certification bodies, quality system registrars, inspection bodies, product verification and training bodies, as well as testing and calibration laboratories.
The regulations on Public Consultation are on INMETRO’s website. INMETRO and CONMETRO use their websites to inform the public about updates to technical regulations.