Brazil

Background

The need to incorporate to regulation concepts new politic-institutional views was motivated by a change of perception that prevailed until the 1980s, whereby regulation was understood as an activity exclusively developed by the government, having, as an objective, the change of behaviour in the private sector by compulsory measures.

With the abrupt growth of private-sector participation in the regulatory regimens in the coming decade, as a consequence of the privatization of many public companies and the creation of regulatory agencies, the traditional sense began to be modified by the acknowledgement that the border between the public and private sectors had become less defined in these regimens, adding to regulatory governance a variety of actors outside the public sector, especially in international affairs.

The above-mentioned political institutional environment enabled the growth of the regulation concept, favouring the adoption of voluntary normative documents within public regulations, some of which from private initiatives such as technical standards.

This scenario also resulted in the acknowledgment by public authorities of the standardization practices and conformity assessment conducted by the private sector, which began to replace the regulations with centralized characteristics, to which the public authorities centralized within their own structures the regulation and conformity assessment processes.

ISO Member Body

The Associação Brasileira de Normas Técnicas (ABNT) is the ISO Member body in Brazil.

Change of approach

Within this new environment, co-regulation activities prospered, which, when applied to the public regulatory regimens, can produce effective results, without the risk of creating technical barriers to trade or distortions within the Brazilian regulatory system.

Albeit desirable, the successful implementation of this type of regimen depends on the ability to convince interested parties involved in the process of their importance. This is not always possible when the standardization activity involves public responsibilities of private interest, particularly when related to healthcare, safety, environment and consumer rights.

Besides co-regulation, which constitutes a public activity with private participation, self-regulation is another activity that is well recognized in Brazil as an alternative to achieve objectives that are of interest to society. In this case, non-governmental bodies establish a contract or private regulatory regimens that can bring economic, social or environmental benefits.

Both co-regulation and self-regulation have proved more cost-effective for achieving political goals than the compulsory traditional legal approach. This assertion is justified by the fact that, by adopting private normative documents of interest or commitment to society, public authorities obtain consensus and natural adhesion to achieve their political goals.

Standardization as a support to regulations

According to the Brazilian National Metrology, Standardization, Industrial Quality Council (Conmetro), a regulation is:

A normative act, with a compulsory character, emanating from a government authority with specific competence to edit it, which contains legislative, regulatory or administrative rules and that establishes specifications for a product or service, subject to the rules approved by Conmetro.

This definition is not limited to the technical prescriptions for an object, but also includes legislative and administrative rulings.

Brazilian overview of current scenario

In order to provide a practical overview of standards used in Brazilian law and public regulations, it is important to mention that standards are seen as important tools to support legislation in specific sectors and at all levels of government. In many cases, standards are fully incorporated into government regulation and have the same weight as a law.

By way of example, technical standards are commonly used by the National Metrology, Quality and Technology Institute (Inmetro) as the basis for developing its technical regulations for healthcare products, adaptors of electrical cables, plugs and sockets, helmets for motorcycles drivers and passengers and similar, amongst many other products and safety processes. Some examples:

Portaria Inmetro nº 386, which regulates mattresses made of flexible polyurethane foam, mentions ABNT NBR 13579-1, Mattres and thinner mattress fully made of flexible polyurethane foam and bases Part 1: Requirements and test methods, and ABNT NBR 13579-2, Mattres and thinner mattress fully made of flexible polyurethane foam and bases Part 2: Covering.

Another example is the Brazilian National Oil, Natural Gas and Biofuel Agency (ANP) where standards are used to help regulate the sector in terms of oil extraction, transport and safety in the operations. Some examples:

Resolution ANP nº 14 (11.5.2012), which requires that test method laboratories follow ABNT NBR ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
Resolution ANP nº 40 (25.10.2013), which requires that the specification of gas for automotive use follows ABNT NBR 16041 (Fuel ethanol – Determination of methanol and ethanol content by gas chromatography)

Other areas where standards serve as the basis for technical regulation in Brazil include healthcare agencies, pollutant emissions by vehicles and the performance of household appliances.

Title	Type	Scope	Standard Citation
Deliberação AGENERSA nº 1250 DE 13/09/2012	Regulation	Government concessionaire CEG and CEG RIO (natural gas) - general conditions and rates for natural gas producers, importers and consumers.	Superior heat power (SHP) - The determination of the SHP will be done based on the method from ISO 6976:1995, or later revisions, rounded to three decimals. Its unit of measure is kcal/m³.
Decreto nº 42.012 de 28/08/2009	Law	Addresses certificate of integrated management in health, safety and work environment.	10th Article - Without prejudice to the inclusion, annually, of other requirements, within the discretion of the System Joint Integrated Management Committee, the following information systems/administrative records will be evaluated: V - information system of adoption of management requirements from OSHAS 18001, ISO 14001 and ABNT 16001 and SA 8000.
Deliberação AGENERSA Nº 1061 DE 19/04/2012	Regulation	Government concessionaire CEG (natural gas) - addresses monitoring criteria of Physico-Chemical (CFQ) characteristics of canaliculate natural gas.	3.1 The monitoring of the CFQ can be replaced by the transfer of constant data within the certificates provided by the Transporter and/or Carrier, required the establishment of a certain frequency in ANP Ordinance and ISO 6974/5, leaving it to the dealers to check the consistency of the data received, on their own at least once a month through the gas analysis effectively distributed.
Portaria Normativa FF/DE nº 178 DE 14/03/2013	Regulation	Addresses the activity of scuba diving in Conservation Units of Integral Protection administered by the Forest Foundation.	I - Respect and obey the municipal, state and federal environmental legislation, as well as all applicable standards to the activity of free diving, including the guidance from ABNT NBR ISO 24803 or other document that may replace it. II - Operations that evolve the teaching and evaluation shall be conducted by an diving instructor with relevant certification equivalent to the standard ABNT NBR ISO 24802-1. III - Operation that only evolve the conduction of divers in open waters shall take place by an diving instructor with equivalent certification to the standard ABNT NBR ISO 24801.
Resolução Conjunta SMA nº 91 DE 14/11/2012	Regulation	Address studies planned for the environmental licensing of aquaculture in cases of ordinary and simplified procedures established by the law 58.544 of 13.11.2012.	The group of Internet protocols that allow the machine communication, the TCP/IP, correspond to the layers functions 3 and 4 from the OSI architecture (Open System Interconnection), developed by the International Organization for Standardization (ISO), ISO/IEC 17025.
Inpa integra Rede Nacional de Análise de Alimentos	Government initiative	Laboratory of the National Institute of Amazonian Research shall contribute to food security and development of the country.	The Renali is formed by a group of public laboratories and nonprofit organizations from Brazil, which have a quality management system in place or accredited based on the standard ABNT NBR ISO/IEC 17025:2005 (requirements for the competence of test and calibration laboratories).
Regulamento Técnico da Qualidade para Fornos de Micro-ondas	Regulation	Establish the minimum technical requirements that must be met by microwave ovens, with a focus on energy efficiency and safety, aiming towards energy conservation and the prevention of electrical hazards.	“[...] The microwave ovens that demonstrate fulfillment established in the International Standards listed below, and its recent versions, and that considered the criteria established within this document, will be in accordance with the performance requirements.” IEC 60705, Household microwave ovens – Methods for measuring performance IEC 62301, Household electrical appliances – Measurement of standby power
Portaria n.º 138, de 17 de março de 2011	Regulation	General labelling requirements to demonstrate the efficiency through certification.	ABNT NBR ISO 9001, Quality management systems – requirements ABNT NBR ISO/IEC 17000:2005, Conformity assessment – Vocabulary and general principles ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories ABNT NBR ISO 14001, Environmental management systems – Requirements with guidance for use
Resolução CD/ANATEL nº 412 de 09/08/2005	Regulation	Approves the standard for certification and homologation of public telephones.	Abbreviations for this standard are adopted as: IV - dBPa(A) - Decibel relative to 1 Pa measured with A-weighting (IEC 60651) VI - dB SPL(A) - Decibel relative to 20 μPa measured with A-weighting (IEC 60651) 5. References: I - IEC 60651, Sound level meters II - IEC 60318-1 (1998-07), Electroacoustics – Simulators of human head and ear - Part 1: Ear simulator for the calibration of supra-aural earphones III - ISO 226, Acoustics – Normal equal-loudness-level contours
Resolução CD/ANATEL nº 533 de 10/09/2009	Regulation	Approves the standard for certification and homologation of Telecommunications Equipment Regarding Aspects of Assessment of Specific Absorption Rate (SAR).	VI - IEC 62209 - 01:2005. Human exposure to radio frequency fields from hand-held and body-mounted wireless communication devices - Human models, instrumentation, and procedures - Part 1: Procedure to determine the specific absorption rate (SAR) for hand-held devices used in close proximity to the ear (frequency range of 300 MHz to 3 GHz), 2005. VII - IEC 62209 - 02 - DRAFT. Human exposure to radio frequency fields from hand-held and body-mounted wireless communication devices - Human models, instrumentation, and procedures - Part 2: Procedure to determine the Specific Absorption Rate (SAR) in the head and body for 30 MHz to 6 GHz Handheld and Body-Mounted Devices used in close proximity to the Body, 2008.
Decreto nº 6.717 de 30/01/2008	Law	Approves and ratifies the Covenants ICMS 110/07 to 150/07, Protocols ICMS Nos 46/07, 72/07 to 75/07, 85/07, 86/07, 88/07 and 96/07, and Adjustments SINIEF paragraphs 8/07 to 14/07 and amending Decree No 4,852, of December 29, 1997, Regulation of the Tax Code of the State of Goiás.	Article 42 - Besides the requirements in this annex, the ECF shall be in accordance with the following standards related to quality, trust and the electronic equipment safety from the International Electrotechnical Commission (IEC): I - IEC 61.000-4-2 II - IEC 61.000-4-3 III - IEC 61.000-4-4 IV - IEC 61.000-4-5 V - IEC 61.000-4-6 VI - IEC 61.000-4-11
Norma Regulamentadora nº 34 DE 21/01/2011	Regulation	NR 34 - CONDITIONS AND WORK ENVIRONMENT IN THE CONSTRUCTION INDUSTRY AND NAVAL REPAIR.	34.14.2 The development and qualification on the procedure, as well as the execution and testing supervision shall take place by a qualified professional according to the relevant national standards and independent bodies that apply the International Standard ISO/IEC 17024.
Instrução Normativa DC/ANVISA nº 3 de 21/06/2011	Regulation	Establishes the list of technical standards whose requirements must be met for certification of compliance within the Brazilian System of Conformity Assessment (SBAC), equipment system under Health Surveillance, under Resolution DC/ANVISA No 27 of 2011.	“[...] The equivalent of this standard within IEC, being IEC 60601-1 Ed. 3.0 b - Medical electrical equipment Part 1: General requirements for basic safety and essential performance, may be accepted in the certification processes, replacing the Brazilian version in place. [...]” The standards contained in the series ABNT NBR IEC 60601 listed, as well as its amendments, will be compulsory to all equipments under regimen of the Health Surveillance that are within its respective fields of application, considering the following situations.
Portaria MTE nº 485 de 11/11/2005	Regulation	Approves Regulatory Standard 32 (Health and Safety at Work in Health).	Constructed of tissue-equivalent material with calibration factor well established and traced by the national and international network of metrology, whose characteristics are governed by the standards ISO 4037-1 and IEC 731. Also called individual monitor.
Resolução ANP nº 16 de 17/06/2008	Regulation	Establishes the specification of natural gas, national or importer to be sold nationwide.	2 - The unit system to be applied to the Technical Regulation is the SI according to the Brazilian standard NBR/ISO 1000. 4 - Applicable Standards: the determination of the product characteristics will be done with the application of the ISO, ABNT and ASTM standards. (ISO 10715)
Resolução ANP nº 52 de 29/12/2010	Regulation	Establishes, within the Technical Regulation ANP, the specifications of the waterway fuels marketed by various economic agents throughout the country.	Considering the uncertainties that evolve the safety of the use of biodiesel in the mixture of oil diesel in the maritime environment, according to the understanding of International Standard ISO 8217, which does not recommend this addition.
NORMA TÉCNICA 09/2014	Regulation	Horizontal and vertical partitioning.	The horizontal partitioning is intended to avoid the propagation off fire in the pavement of origin to other environments in the horizontal plane. ISO 1182, Reaction to fire tests for products - Non combustibility tests.
Instrução Normativa IBAMA nº 126 de 24/10/2006	Regulation	Establishes criteria for checking the operation of devices/systems for on-board diagnostics OBDBr-1 directly (electrical continuity) or indirectly, following the International Standards ISO 15031, Parts 3, 4, 5 and 6, and ISO 2575.	“Article 1 - Establish criteria for checking the operation of devices/systems for on-board diagnostics OBDBr-1 directly (electrical continuity) or indirectly, following the International Standards ISO 15031, Parts 3, 4, 5 and 6, and ISO 2575. Single paragraph. For compliance with the requirements of this normative instruction ISO International Standards cited shall be used, until equivalent national regulatory instruments are established. ”
Portaria Interministerial MDIC/MCT nº 372 de 01/12/2005	Regulation	Sets deadline for implementation of the Quality System based on ISO 9000 standards of the Brazilian Association of Technical Standards (ABNT) for manufacturers of industrial products in the Manaus Free Trade Zone (MFZ).	Article 1 - For manufacturers of industrial products in the Zona Franca de Manaus (MFZ) with industrial project approved by the Superintendence Board of the Manaus Free Trade Zone (SUFRAMA), the deadline for the implementation of the Quality System based on ISO standards 9000, as well as for submission to SUFRAMA, their Quality System Certificates, issued by the National Institute of Metrology, Standardization and Industrial Quality (INMETRO), or certification body accredited by this body will be thirty months, counted from the date of issue of the first Production Report (PR).
Instrução Normativa IBAMA nº 4 de 12/05/2010	Regulation	Establishes the technical and certification requirements for the systems on-board self-diagnosis (OBD) to be installed in all new trucks Diesel Confirmed at P-7 Phase Control Program of Air Pollution from Motor Vehicles-PROCONVE.	Legislation and standards that are referred within this standard: ISO 15031-1 - ISO 15031:2001, Road vehicles – Communication between vehicle and external equipment for emissions-related diagnostics – Part 1: General information. ISO 15031-2 - ISO/PRF TR 15031-2:2004, Road vehicles – Communication between vehicle and external equipment for emissions-related diagnostics – Part 2: Terms, definitions, abbreviations and acronyms. ISO 15031-3 - ISO 15031-3:2004, Road vehicles – Communication between vehicle and external equipment for emissions-related diagnostics – Part 3: Diagnostic connector and related electrical circuits, specification and use. ISO 15031-4 - ISO DIS 15031-4.3:2004, Road vehicles – Communication between vehicle and external equipment for emissions-related diagnostics – Part 4: External test equipment. ISO 15031-5 - ISO DIS 15031-5.4:2004, Road vehicles – Communication between vehicle and external equipment for emissions-related diagnostics – Part 5: Emissions-related diagnostic services. ISO 15031-6 - ISO DIS 15031-6.4:200, Road vehicles – Communication between vehicle and external equipment for emissions-related diagnostics – Part 6: Diagnostic trouble code definitions. ISO 15031-7 - ISO 15031-7:2001, Road vehicles – Communication between vehicle and external equipment for emissions-related diagnostics – Part 7: Data link security. ISO 15765-4 - ISO 15765-4:2001, Road vehicles – Diagnostics on Controller Area Network (CAN) – Part 4: Requirements for emissions-related systems. ISO 16185 - ISO 16185:2000, Road vehicles – Engine families for certification of heavy-duty vehicles by exhaust emission. ISO 2575 - ISO 2575:2000, Road vehicles – Symbols for controls, indicators and tell-tales. ISO 16183 - ISO 16183:2002, Heavy duty engines – Measurement of gaseous emissions from raw exhaust gas and of particulate emissions using partial flow dilution systems under transient test conditions.
Resolução Conjunta ANP/INMETRO nº 1 DE 10/06/2013	Regulation	Approves the Technical Regulation on Measurement of Petroleum and Natural Gas.	1. International Organization for Standardization. ISO 91-2:1991, Petroleum measurement tables – Part 2: Tables based on a reference temperature of 20 degrees C. Genebra, 1991. 3 p. 6.2 - ISO 2714:1980, Liquid hydrocarbons – Volumetric Measurement by Displacement Meter Systems Other Than Dispensing Pumps. Genebra, 1980. 8 p. 6.3 - ISO 2715:1981, Liquid hydrocarbons – Volumetric Measurement by Turbine Meter Systems. Genebra, 1981. 15 p. 6.4 - ISO 3170:2004, Petroleum Liquids – Manual Sampling. Genebra, 2004. 55 p. 6.5 - ISO 3171:1988, Petroleum Liquids – Automatic Pipeline Sampling. Genebra, 1988. 55 p. 6.6 - ISO 4266-1:2002, Petroleum and Liquid Petroleum Products – Measurement of Level and Temperature in Storage Tanks by Automatic Methods – Part 1: Measurement of Level in Atmospheric Tanks. Genebra, 2002. 18 p. 6.7 - ISO 4266-2:2002, Petroleum and Liquid Petroleum Products – Measurement of Level and Temperature in Storage Tanks by Automatic Methods – Part 2: Measurement of Level in Marine Vessels. Genebra, 2002. 11 p. 6.8 - ISO 4266-4:2002, Petroleum and Liquid Petroleum Products – Measurement of Level and Temperature in Storage Tanks by Automatic Methods – Part 4: Measurement of Temperature in Atmospheric Tanks. Genebra, 2002. 14 p. 6.9 - ISO 4266-5.2002, Petroleum and Liquid Petroleum Products – Measurement of Level and Temperature in Storage Tanks by Automatic Methods – Part 4: Measurement of Temperature in Marine Vessels. Genebra, 2002. 12 p. 6.10 - ISO 4267-2:1988, Petroleum and Liquid Petroleum Products – Calculation of Oil Quantities – Part 2: Dynamic Measurement. Genebra, 1998. 24 p. 6.11 - ISO 4268:2000, Petroleum and Liquid Petroleum Products – Temperature Measurements – Manual Methods. Genebra, 2000. 32 p. 6.12 - ISO 4512:2000, Petroleum and Liquid Petroleum Products – Equipment for Measurement of Liquid Levels in Storage Tanks – Manual Methods. Genebra, 2000. 26 p. 6.13 - ISO 5167-1:2003, Measurement of fluid flow by means of pressure differential devices inserted in circular cross-section conduits running full – Part 1: General principles and requirements. Genebra, 2003. 33 p. 6.14 - ISO 5167-2:2003, Measurement of fluid flow by means of pressure differential devices inserted in circular cross-section conduits running full – Part 2: Orifice plates. Genebra, 2003. 47 p. 6.15 - ISO 5168:2005, Measurement of fluid flow – Procedures for the evaluation of uncertainties. Genebra, 2005. 65 p. 6.16 - ISO 6551:1982, Petroleum Liquids and Gases – Fidely and Security of Dynamic Measurement – Cabled transmission of electric and/or electronic pulsed data. Genebra, 1982. 12 p. 6.17 - ISO 6578:1991, Refrigerated hydrocarbon liquids – Static measurement – Calculation procedure. Genebra, 1991. 20 p. 6.18 - ISO 6974-1:2000, Natural gas – Determination of composition with defined uncertainty by gas chromatography – Part 1: Guidelines for tailored analysis (available in English only). Genebra, 2000. 16 p. 6.19 - ISO 6974-2:2001, Natural gas – Determination of composition with defined uncertainty by gas chromatography – Part 2: Measuring-system characteristics and statistics for processing of data (available in English only). Genebra, 2001. 24 p. 6.20 - ISO 6976:1995, Natural gas – Calculation of calorific values, density, relative density and Wobbe index from composition. Genebra, 1995. 46 p. 6.21 - ISO 6976:1997 - Cor 2/1997. Genebra, 1997. 1 p. 6.22 - ISO 6976:1999 - Cor 3/1999. Genebra, 1999. 1 p. 6.23 - ISO 7278-1:1987, Liquid Hydrocarbons – Dynamic Measurement – Proving Systems for Volumetric Meters – Part 1: General Principles. Genebra, 1987. 5 p. 6.24 - ISO 7278-2:1988, Liquid Hydrocarbons – Dynamic Measurement – Proving Systems for Volumetric Meters – Part 2: Pipe Provers. Genebra, 1988. 18 p. 6.25 - ISO 7278-3:1998, Liquid Hydrocarbons – Dynamic Measurement – Proving Systems for Volumetric Meters – Part 3: Pulse Interpolation Techniques. Genebra, 1998. 12 p. 6.26 - ISO 7278-4:1999, Liquid Hydrocarbons – Dynamic Measurement – Proving Systems for Volumetric Meters – Part 4: Guide for Operators of Pipe Provers. Genebra, 1999. 27 p. 6.27 - ISO 8943:2007, Refrigerated light hydrocarbon fluids – Sampling of liquefied natural gas – Continuous and intermittent methods. Genebra, 2007. 20 p. 6.28 - ISO 9770:1989, Crude petroleum and petroleum products – Compressibility factors for hydrocarbons in the range 638 kg/m³ to 1 074 kg/m³. Genebra, 1989. 1 p. 6.29 - ISO 10715:1997, Natural Gas – Sampling guidelines. Genebra, 1997. 39 p. 6.30 - ISO 10723:1995, Natural Gas – Performance evaluation for on-line analytical systems. Genebra, 1995. 43 p. 6.31 - ISO 12213-1:2006, Natural gas – Calculation of compression factor – Part 1: Introduction and guidelines. Genebra, 2006. 13 p. 6.32 - ISO 12213-2:2006, Natural gas – Calculation of compression factor – Part 2: Calculation using molar-composition analysis. Genebra, 2006. 32 p. 6.33 - ISO 12213-3:2006, Natural gas – Calculation of compression factor – Part 3: Calculation using physical properties. Genebra, 2006. 38 p. 6.34 - ISO 16664:2004, Gas Analysis – Handling of Calibration Gases and Gas Mixtures – Guidelines. Genebra, 2004. 17 p. 6.35 - ISO 18132-1:2006, Refrigerated light hydrocarbon fluids – General requirements for automatic level gauges – Part 1: Gauges onboard ships carrying liquefied gases. Genebra, 2006. 8 p. 6.36 - ISO 18132-2:2008, Refrigerated light hydrocarbon fluids – General requirements for automatic level gauges – Part 2: Gauges in refrigerated-type shore tanks. Genebra, 2008. 8 p.