National Examples

As the benefits of using standards to support public policies have become more widely recognized, many major economies of the world have developed policies to actively encourage their use. The examples on this website provide summary positions from different countries of their current policies on using standards to support public policy initiatives, including technical regulations.

For each country, there are also examples of extracts from the text of regulations and other policies.

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The Associação Brasileira de Normas Técnicas (ABNT) is the ISO Member body in Brazil : http://www.abnt.org.br/
The need to incorporate to regulation concepts new politic-institutional views was motivated by a change of perception that prevailed until the 1980's, whereby regulation was understood as an activity exclusively developed by the government, having, as objective, the change of behavior in the private sector by compulsory measures.

With the abrupt growth of participation of the private sector in the regulatory regimens in the following decade, in consequence of 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 became less defined in these regimens, adding to the regulatory governance a variety of actors outside the public sector, especially in international affairs.

This above-mentioned politic-institutional environment enabled the growth of the regulation concept, favoring the adoption of voluntary normative documents within the public regulations, some of those from private initiative, 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, that started to replace, in consequence, the regulations with centralized characteristics, to which the public authorities centralized within their own structures the regulation and conformity assessment processes.

The change of approach

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

Although desirable, the successful implementation of this type of regimen depends on convincing the interested parties in the process of their importance, which is not always possible when the standardization activity involves public responsibilities of private interest, particularly when it is related to health care, safety, environment and consumer rights.

Besides the co-regulation, which constitutes a public activity with private participation, the self-regulation also represents another activity that has been well recognized in Brazil as an alternative to achieve objectives that are interesting to the 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 are activities that have proven to be, in many situations, alternatives that offer a cost-effective relation to achieve political goals better than the compulsory, traditional legal approach. This assertion is justified due to the fact that by adopting private normative documents of interest or commitment of 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 include legislative and administrative rulings.

Brazilian overview of current scenario

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

To present a few good practical examples of the Brazilian current scenario, technical standards are commonly used by the National Metrology, Quality and Technology Institute (Inmetro) as the basis to develop their technical regulations regarding health care products, adaptors of electrical cables, plugs and sockets, helmets for drivers and passengers of motorcycles and similar, amongst many other products and safety processes. Some examples:

  • Portaria Inmetro n.º 386, which regulates mattres made of flexible polyurethane foam, mentions ABNT NBR 13579-1 (Mattres and thinner mattress fully made of flexible polyurethane foam and basesPart 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)

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

  • Resolution ANP nº 14 (11.5.2012), which regulates that test method laboratories have to follow mentions ABNT NBR ISO IEC 17025 (General requirements for the competence of testing and calibration laboratories);
  • Resolution ANP nº 40 (25.10.2013), which regulates the specification of gas for automotive use mentions ABNT NBR 16041 (Fuel ethanol — Determination of methanol and ethanol content by gas chromatography).

Many other examples where standards serve as a basis for technical regulation in Brazil can also be found in health care agencies, pollutants emissions by vehicles, and performance of household appliances.

Document 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, de 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 to energy conservation and the prevention of electrical hazards. "[...] The microwave ovens that demonstrate fulfillment established in the International Standards listed bellow, 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 Labeling Requirements to demonstrate the efficiency through Certification ABNT NBR ISO 9001 – Quality management system – requirements
ABNT NBR ISO/IEC  17000:2005 – Conformity assessment – Vocabulary and general principles ISO/IEC 17025
General requirements for the competency of test and calibration laboratories.
ABNT NBR ISO 14001 Environment management system – Specification and guidelines 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 Pascal 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 No 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 wit 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 combustible test"
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 indirect, 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 indirect, following the international standards ISO 15031, parts 3, 4, 5 and 6, and ISO in 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 will be used. "
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 15031-1: 2001: ""Road vehicles - Com-munication 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: 2004: ""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 family for homologation"".
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.

 

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The Standards Council of Canada (SCC) is the ISO Member body in Canada: https://www.scc.ca/

In accordance with the Government of Canada’s Cabinet Directive on Regulatory Management, federal government departments and agencies are responsible for assessing the effectiveness and appropriateness of regulatory and non-regulatory instruments for achieving public policy objectives.

Canadian federal departments and agencies are to:

  1. Identify the institutions and parties that should be involved in addressing the public policy issue;
  2. Identify the appropriate instrument or mix of instruments, including regulatory and non-regulatory measures, and justify their application before submitting a regulatory proposal;
  3. Consider potential alternatives to regulation, including voluntary standards, information disclosure, and guidelines, and whether outcome or performance based approaches would be suitable;
  4. Engage small businesses in alternative approaches to compliance (including costs);
  5. Demonstrate that the regulatory response is designed to address policy objectives;
  6. Demonstrate that the regulatory response is proportional to the degree and type of risk;
  7. Demonstrate that the regulatory response will not unduly affect areas that it was not designed to address;
  8. Specify, particularly for technical regulations, regulatory requirements in terms of their performance rather than their design or descriptive characteristics; and
  9. Make use of all or parts of relevant national or international standards, guidelines, and recommendations as a basis for technical regulations and for conformity assessment procedures when they fulfill intended policy objectives.
Canadian Policy / Regulation Reference to standard/s

Organic Products Regulations, 2009 (SOR/2009-176)
(Canadian Food Inspection Agency)

s.9(1): Subject to subsection (2), on the recommendation made in a report of the conformity verification body, the Agency shall suspend the accreditation of a certification body if the certification body has not complied with any provision of the Act, these Regulations or ISO/IEC 17065.

Polybrominated Diphenyl Ethers Regulations (SOR 2008-218)
(Ministry of Environment Canada)

s.8: The presence of any polybrominated diphenyl ether shall be determined by a laboratory that is accredited under the International Organization for Standardization standard ISO/IEC 17025: 2005, entitled General requirements for the competence of testing and calibration laboratories, as amended from time to time, and whose accreditation includes the analysis of polybrominated diphenyl ethers within its scope of testing.

Navigation Safety Regulation (SOR/2005-134)
(Ministry of Transport Canada)  

s.10(2): If a ship is constructed on or after July 1, 2002, all electrical and electronic equipment on the bridge or in the vicinity of the bridge shall be tested for electromagnetic compatibility, taking into account testing standard IEC 60533 of the International Electrotechnical Commission, entitled Electrical and electronic installations in ships — Electromagnetic compatibility.
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The Standardization Administratio of China (SAC) is the ISO Member body in China: http://www.sac.gov.cn/

Background

One of the main forms of China’s technical regulation is mandatory standards at national, professional and local levels. It is stipulated in the Standardization Law of the People’s Republic of China that “standards for assuring health, and the safety of persons and their properties, and standards prescribed in laws and administrative regulations are compulsory, mandatory standards. Products that do not comply with mandatory standards are prohibited to be produced, sold or imported.” Thus, it can be seen that mandatory standards have the characteristics of technical regulations.

Since China joined the WTO in accordance with the relevant requirements of the WTO, all China’s mandatory standards concerning trade  have been notified and have been  largely recognized by the international society. By the end of the year 2013, the total number  of China’s mandatory standards was 3712.

It is stipulated in the Standardization Law of the People’s Republic of China that certain standards from the following categories can be mandatory standards depending on the risk that the product  or activity poses:

  • Pharmaceutical standards; food sanitary standards; animal medicine standards,
  • Safety and sanitary standards for products and standards for the production, storage and transportation, and use  of products; occupational health and safety standards; transportation safety standards,
  • Quality, safety and sanitary standards for engineering construction, and other engineering construction standards that the government needs to control,
  • Pollutant emission standards and environment quality standards for environmental protection,
  • Important general technical terminology, symbols, codes and drawing method standards,
  • General testing, checking and inspecting method standards,
  • Some  interchanging and fitting standards,
  • Important quality standards that the government needs to control.

Main forms of using standards in Chinese technical regulations

China’s national standards are mainly usedin technical regulations in the following three forms:

A) A mandatory standard itself becomes the technical regulation
As described above this is the most important form of technical regulation in China.

B) Standards are either directly or indirectly quoted
The use of standards will become mandatory if quoted in regulatory documents such as legislative texts and departmental regulations. In most cases, the indirect option is chosen. For example, the relevant text of the regulatory document will state“…should comply with national or industrial standards…”

C) Part of a recommended standard is quoted in mandatory standards
This is where an extractof a standard is reproduced as part of the text of the regulatory document. The requirements in the extractwill then become compulsory.

Summary

The above three methods of referencing standards reflect the situation of how China's national standards are used in technical regulations. When choosing which option to use and indeed which standard to reference, the WTO/TBT principles are applied. This means that if an international standard is available and it is considered to be suitable for China's situation, efforts will be made to adopt the international standard. This ensures that international standards indeed become China's technical regulations. At the time of writing this Guide, about 74 % of China's standards are developed based on related international standards.
The Chinese view on using standards in support of technical regulation is that, on the one hand, technical standards can help laws to regulate the market and, on the other hand, they can help legal and administrative measures to conduct necessary intervention in order to establish fair and reasonable competition for the market economic order. In China, laws only stipulate the general rules, while standards specify the technical criteria that facilitate the implementation of laws; and, in return, the implementation of laws can promote the carrying out of standards. Therefore, laws and standards actually supplement each other, working together for the realization of the overall objectives specified in the law and the implementation of technical standards. At the same time, standards are implemented compulsorily during the implementation process of laws.

Chinese Policy / Regulation Reference to standard/s

Energy Conservation Law
of the People’s Republic of China
(The 30th meeting of the standing committee of the 10th national people’s congress, revised on October 28, 2007

Clause 15: The state carries out energy conservation assessment and examination system on fixed assets investment projects. If these projects fail to meet the mandatory standards of energy conservation, authorities responsible for their examination in accordance with the law should not give approval. Construction units should not start constructing. Those that have already been constructed should not be brought in operation. Specific methods should be formulated by energy conservation management department under the state council in conjunction with related departments.

Product Quality Law of the People’s Republic of China

Clause 13: Industrial products that could possibly endanger people’s health and the safety of persons and their properties must comply with national and industrial standards special for safeguarding people’s health, safety and properties. Industrial products that fail to meet the standards and requirements special for safeguarding people’s health, safety and properties are prohibited to be produced and sold.

Clause 14: Government promotes enterprise quality system certification according to the internationally practiced quality management standards.

The Order of the State administration of work safety of the People’s Republic of China Implementary methods for safety production license for firework and firecracker production enterprises 

Clause 8: Infrastructures of enterprises, such as workshops and warehouses, production equipments, production technology, and safety facilities which are anti-fire, explosion-proof, lightning protection and anti-static should conform to stipulations of national standards and industrial standards ,such as Safety code for design of engineering of fireworks and firecracker( GB50161) and Technical regulations for the working safety of fireworks and firecrackers( GB11652).

Clause 11: The variety, category, level, specification, quality, packaging and mark of products of the enterprises should conform to stipulations of national standards and industrial standards, such as Safety and quality for fireworks ( GB10631).
The Order of the Ministry of Health of the People’s Republic of China Safety and Sanitary Management Method  for Food Additives

Chapter 1, Clause 3: Food additives must comply with national safety and sanitary standards.

Chapter 3, Clause 13: Production and Management:
For those who produce compound food additives, the range and amount of every single food additive must  comply with the “Safety and sanitary standards for the use  of food additives” or the categories and their range  and amount  of use  specified in the list announced by the Ministry of Health.

Chapter 4, Clause 19: In the instruction for use of labels it is stipulated: For compound food additives, in addition to the requirements of labels specified in Clause 18, the name  of any single food additive should also be labelled at the same  time, and listed from big to small according to the amount  contained in the compound food additives; the name  used  for any single food additive must be the same  as specified in “Safety and sanitary standards for the use  of food additives”.
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Background

The European standardization system consists of three European Standards Organizations (ESOs), CEN, CENELEC and ETSI[1] and their national member standards bodies. European standards developed are implemented identically by all member bodies, with conflicting standards withdrawn. Starting work on a European standard begins a period of standstill where national members cannot continue or start work on an identical subject.

In this way, the European system is one of a single standard for the whole of the internal market across Europe, comprising the 28 members of the European Union, the EFTA members of the European Economic Area and other full members of CEN and CENELEC. The single standard brings the benefits of clarity and certainty for industry and enables easier reference in legislation.  From the perspective of the European Union, the pan-European consensus of all Member States’ standard bodies that is contained in European standards give them the legitimacy to be used for public policy purposes. 

European standardization is an integral part of European Union single market and is viewed as a tool to increase the competitiveness of enterprises and to remove barriers to trade  at the international level. The European  standardization system  is based on European law, Regulation 1025/2012. This includes the following ‘founding principles’ that are recognized by the WTO: ‘coherence, transparency, openness, consensus, voluntary application, independence from special interests and efficiency’.

Regulation 1025/2012 sets out the legal framework for the interaction between the European Union – mainly through the European Commission – and the European standardization system. This interaction comes mainly through the co-regulatory ‘New Approach’ to technical harmonization. In addition to this, some standards are used to support European policies without a legal framework, such as in the ICT and accessibility areas.

The European ‘New Approach’ to technical harmonization

The European Union uses standards to support both its legislation and policies. The primary use of standards is as part of a co-regulatory model known since the 1980s as the ‘New Approach’ to technical harmonization. This has been updated and refined in the ‘New Legislative Framework’ from 2008.
There are now about 25 different legislative acts that follow the New Approach principles, for products as diverse as toys, machinery, gas appliances, medical devices, personal protective equipment, pyrotechnics, electrical equipment and recreational craft. There is other European legislation, like the General Product Safety Directive, that follows a similar model to the New Approach.

In the New Approach, European harmonization is limited to the ‘essential requirements’ that products must meet before they can have free circulation within the single market. European law contains these essential requirements.
The European Commission requests the ESOs to develop and adopt European standards, referred to as ‘harmonized standards’, by issuing a standardization request (‘mandate’). The ESOs choose whether or not to accept the mandate; if they accept they develop the requested standard(s) following the normal procedure for European standards. The policies of the ESOs are to use International Standards wherever they exist and are suitable.

Once  the harmonized standards are published, they are notified to the European Commission. If all procedures are considered to have been satisfied, the Commission publishes the references of the standard in the Official Journal of the European Union. The references of about 4500 European standards are published in the Official Journal.

Once the references are published, products manufactured in accordance with the harmonized standard receive a presumption of conformity with the relevant essential requirements of the legislation. The presumption of conformity is the crucial element in this co-regulatory approach that links the public interest (i.e. protecting public health and safety, consumer and environmental protection) and the interest of private business.

Manufacturers are nevertheless free to choose any other technical solution that can demonstrate compliance with the essential requirements of the law, as long as they follow the appropriate conformity assessment model. Compliance with standards is therefore still voluntary, even though their use brings advantages in terms of simplicity and cost effectiveness.

EU Directive ‘New approach’ indirect reference to standards

Directive 2009/48/EC, Safety of Toys

Note: this is an example of a European ‘New Approach  Directive’ that meets the requirements of the New Legislative Framework. There are more than 20 European legislative acts that follow the New Approach, and a number of others that use similar principles. These include machinery, low voltage electrical equipment, electromagnetic compatibility, personal protective equipment, recreational craft, gas appliances, pyrotechnics and medical devices. All New Approach legislation is being updated to meet the requirements of the New Legislative Framework. The legislation also refers to the legislation on European standardization, Regulation 2015/2012, which sets procedures for the Commission to request harmonized standards from the European Standards Organizations and to decide on formal objections against standards.

Article 13 of the Directive states that “Toys which are in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the [essential requirements of the Directive]”. 

Article 14.1 states that Member States of the European Union or the European Commission can raise a formal objection against the publication of the references of the standard if it does not entirely satisfy the essential safety requirements of the Directive. The standard is then considered by expert groups and the Commission’s committee on standards before a decision is made about whether the standard can continue to provide a presumption of conformity.

Directive 2001/95/EC on general product safety
Note: This is not a New Approach Directive, but uses similar principles by referring to standards.

This legislation applies when there is no other European or national legislation covering the safety of consumer products. It sets a general requirement that products must be safe. In a similar way to the New Approach directives, a product is presumed to be safe when it conforms to voluntary national standards transposing European  standards, the references of which are  published by the Commission in the Official Journal of the European Communities

If a standard does not ensure compliance with the general safety requirement, the Commission must withdraw the published reference to the standard, in whole or in part.

Some national examples from France

AFNOR is the ISO Member body in France: http://www.afnor.org/en

Examples of French regulatory texts which refer to standards

French Policy / Regulation Reference to standard/s

Décret n°94-699 du 10 août 1994 fixant les exigences de sécurité relatives aux équipements d'aires collectives de jeux.

(Note : il s'agit d'un exemple de réglementation nationale de type "nouvelle approche")
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Decree No 94-699 of 10 August 1994 fixing the safety requirements relating to collective playgrounds equipment.

(Note: this is an example of national regulation of the "new approach" type)

.

Art. 3 "Les équipements d'aires collectives de jeux doivent satisfaire aux exigences de sécurité définies en annexe au présent décret".

Art. 4 "Le respect des exigences de sécurité définies en annexe est attesté par la mention : "conforme aux exigences de sécurité"".

Art. 5 "Peuvent seuls comporter la mention : "conforme aux exigences de sécurité" les équipements d'aires collectives de jeux qui satisfont à l'une des deux obligations suivantes :
1°              Avoir été fabriqués conformément aux normes de sécurité françaises ou étrangères les concernant, dont les références sont publiées au Journal officiel de la République française. Dans ce cas, le responsable de la première mise sur le marché des équipements tient à la disposition des agents chargés du contrôle un dossier comprenant une description détaillée du produit et des moyens par lesquels le fabricant s'assure de la conformité de sa production aux normes susmentionnées (…).
2°              S'ils ne respectent pas toutes les normes visées au 1° ci-dessus, être conformes à un modèle bénéficiant lui-même d'une attestation de conformité aux exigences de sécurité délivrée à la suite d'un examen de type effectué par un organisme (…) agréé par le ministre chargé de l'industrie (…)".

La liste des références des normes pouvant être utilisées en application de l’article 5-1 du décret n° 94-699 fait l’objet d’avis publiés régulièrement au Journal officiel de la République française (voir par exemple l’avis publié au JORF du 06 mars 2009).

Décret n° 95-937 du 24 août 1995 relatif à la prévention des risques résultant de l'usage des bicyclettes.

(Note : il s'agit d'un exemple de réglementation nationale de type "nouvelle approche")
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Decree No 95-397 of 24 August 1995 relating to the prevention of risks resulting from the use of bicycles.

(Note: this is an example of national regulation of the "new approach" type)

Art. 3 - Les bicyclettes doivent satisfaire aux exigences essentielles de sécurité figurant en annexe au présent décret (…).

Art. 4 - Le respect des exigences de sécurité est attesté par la mention "Conforme aux exigences de sécurité" (…).

Art. 5 - La mention prévue à l'article [4] ne peut être utilisée que si la bicyclette satisfait à l'une des deux conditions suivantes :

1.               Avoir été fabriquée conformément aux normes de sécurité françaises ou relevant d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord instituant l'Espace économique européen la concernant, dont les références sont publiées au Journal officiel de la République française ; dans ce cas, le fabricant (…) tient à la disposition des agents chargés du contrôle un dossier comprenant la description des moyens par lesquels le fabricant s'assure de la conformité de sa production aux normes susvisées (…).

2.               Etre conforme à un modèle bénéficiant d'une attestation de conformité aux exigences de sécurité délivrée à la suite d'un examen de type par un organisme habilité, français ou relevant d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord instituant l'Espace économique européen, agréé pour l'examen des bicyclettes par le ministre chargé de l'industrie (…).

La liste des références des normes pouvant être utilisées en application de l’article 5-1 du décret n° 95-937 fait l’objet d’avis publiés régulièrement au Journal officiel de la République française (voir par exemple l’avis publié au JORF du 31 mai 2014).

Décret n° 2006-18 du 04 janvier 2006 relatif à la sécurité des barbecues utilisant des combustibles solides.

(Note : il s'agit d'un exemple de réglementation nationale de type "nouvelle approche")
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Decree No 2006-18 of 04 January 2006 relating to the safety of barbecues using solid fuels.

(Note: this is an example of national regulation of the "new approach" type)

Article 3

1° Les barbecues et leurs éléments répondent aux exigences de sécurité énumérées à l'annexe I, de manière à assurer la sécurité des personnes, notamment contre les risques de blessures ou de brûlure.
(…)

Article 4

Sont réputés satisfaire aux dispositions de l'article 3 les produits qui sont :

Soit fabriqués conformément aux normes dont les références sont publiées au Journal officiel de la République française.
(…)

Soit fabriqués conformément à un modèle bénéficiant d'une attestation de conformité aux exigences de sécurité, délivrée à la suite d'un examen de type par un organisme français ou d'un autre Etat membre de la Communauté européenne ou d'un Etat partie à l'accord sur l'Espace économique européen ou de la Turquie, accrédité selon la norme EN/ISO 17025 par le Comité français d'accréditation (COFRAC) ou par un organisme d'accréditation signataire de l'accord multilatéral pris dans le cadre de la coordination européenne des organismes d'accréditation pour le contrôle des produits mentionnés à l'article 1er du présent décret.
(…)

La liste des références des normes pouvant être utilisées en application de l’article 3-1 du décret n° 2006-18 a fait l’objet de l’avis publié au JORF du 01 mars 2006.

Arrêté du 01 août 2006 fixant les dispositions prises pour l'application des articles R. 111-19 à R. 111-19-3 et R. 111-19-6 du code de la construction et de l'habitation relatives à l'accessibilité aux personnes handicapées des établissements recevant du public et des installations ouvertes au public lors de leur construction ou de leur création.
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Order of 01 August 2006 laying down the provisions for the implementation of Articles R. 111-19 to R. 111-19-3 and R. 111-19-6 of the Code of construction and housing relating to the accessibility for people with disabilities in establishment open to the public and in installations open to the public during their construction or their creation.
Art. 7.2 Ascenseurs : "(…) les ascenseurs doivent être conformes à la norme NF EN 81-70 relative à l'"accessibilité aux ascenseurs pour toutes les personnes y compris les personnes avec handicap", ou à tout système équivalent permettant de satisfaire à ces mêmes exigences."

Arrêté du 14 août 2012 relatif aux conditions de mesurage des niveaux d'empoussièrement, aux conditions de contrôle du respect de la valeur limite d'exposition professionnelle aux fibres d'amiante et aux conditions d'accréditation des organismes procédant à ces mesurages.
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Order of 14 August 2012 concerning the conditions for measuring dust levels, the conditions of control compliance with the limit value for occupational exposure to asbestos fibers and the conditions of accreditation of organisms making these measurements.

Art. 3 : "Pour la stratégie d'échantillonnage, la mise en œuvre de la méthode définie dans la norme NF EN ISO 16000-7 de septembre 2007 et son guide d'application GA X 46-033 relatifs à la stratégie d'échantillonnage pour la détermination des concentrations en fibres d'amiante en suspension dans l'air est réputée satisfaire à l'exigence réglementaire d'établissement d'une stratégie d'échantillonnage.
La stratégie d'échantillonnage détermine le nombre minimum de prélèvements à réaliser et leurs conditions de réalisation."

Art. 4 : "Pour les prélèvements, la mise en œuvre de la partie concernée de la norme AFNOR XP X 43-269 d'avril 2012 relative au "Prélèvement sur filtre à membrane pour la détermination de la concentration en nombre de fibres par les techniques de microscopie : MOCP, MEBA et META - Comptage par MOCP" est réputée satisfaire à l'exigence réglementaire de réalisation de prélèvements."

Art. 5 : "L'analyse des prélèvements est réalisée en microscopie électronique à transmission analytique (META).
La mise en œuvre de la norme NF X 43-050 de janvier 1996 relative à la détermination de la concentration en fibres d'amiante par microscopie électronique à transmission est réputée satisfaire à cette exigence réglementaire."

 

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The Japanese Industrial Standards Committee (JISC) is the ISO Member body in Japan: http://www.jisc.go.jp/eng/

Background

In recent  years,  with the progress of regulatory reform, an increasing number  of voluntary Japanese Industrial Standards (JIS) are being adopted as technical standards in regulations, as more and more regulations incorporate performance-based requirements.

Industrial Standardization Law stipulates that JIS standards should be followed when national governments and local governments set technical standards related to mining and manufacturing, or when they create  specifications for their procurement. At the same  time, the WTO/TBT Agreement  specifies that both regulations and technical standards should be harmonized with international standards with a view toward  not creating unnecessary obstacles to international trade.  The WTO/TBT Agreement  reads: “Where technical regulations are required and relevant international standards exist or their completion is imminent, members shall use  them,  or the relevant parts  of them,  as a basis for their technical regulations.” As a member of the WTO, the Japanese government is working to harmonize JIS standards with corresponding international standards to the greatest degree possible. At the same  time, it is encouraging the use  of JIS standards as references when technical standards are required in regulations. Of the over 109,000700  JIS standards currently existing, 54,7800  have corresponding international standards, and 54,6500  of these  are harmonized with their corresponding international standards.

Referencing of JIS standards to regulations and public policy

Ensuring the safety of industrial products is the most important consideration in the context  of protection of consumers and labour. JIS standards are referenced as technical standards for self- declaration and third-party conformity assessment in regulations governing safety. 195 laws apply JIS to technical regulations, 1,300 JIS are cited in laws and regulations and the frequency of citation in the laws and regulations is 6,500. There are about  2,000 JIS standards that are referenced in regulations. The Building Law, Pharmaceutical Affairs Law, and Electrical Appliance and Material Safety Law are examples of regulations referencing JIS standards.

Building Law

The Building Law and its related laws stipulate standards for sites, structures, equipment, and the usage of buildings. According to these  laws, the quality of building foundations, principal building parts and materials used  for building parts  that are important in terms  of safety, fire prevention, and sanitation must  be approved by the Minister of Land, Infrastructure and Transport.  JIS standards are used in this approval testing. Building materials conforming to the JIS standards referenced in these  laws, however,  are not required to obtain such  ministerial approval. Nearly 23040 JIS standards are referenced in these  laws, and,  of these, about  100 are harmonized with their corresponding international standards.

Pharmaceutical Affairs Law

The Pharmaceutical Affairs Law and its related laws provide regulations required to ensure  the quality, efficacy and safety of drugs,  quasi-drugs, cosmetics and medical devices. For in vitro diagnostic medical devices designated in these  laws, manufacturing distributors are required to obtain certification by a third-party certification organization designated by the government. About 1540 JIS standards are referenced in these  laws as performance standards for medical devices. Of this number,  about  40 are harmonized with their corresponding international standards.

Electrical Appliance and  Material Safety  Law

The Electrical Appliance and Material Safety Law and its related ruleslaws establish restrictions on the manufacturing, import and sale of designated electrical products in order to prevent  accidents caused by electrical products. Manufacturers or importers of electrical products are obligated to (1) produce or import electrical products that conform to the technical standards stipulated in the laws; (2) ship those  products with a mark (“PSE” mark) that shows that the electrical products conform to technical standards; and (3) only sell electrical products with the PSE mark. About 29060 JIS standards are referenced in these  ruleslaws, and almost all of them are harmonized with their corresponding international standards.

Basic Policy for the Promotion of Procurement of Eco-Friendly Goods and Services

Basic Policy for the Promotion of Procurement of Eco-Friendly Goods and Services was established in order to promote comprehensive and planned procurement of materials, components, products and services with low environmental impact.  It is considered that local governments, enterprises, and citizens will also make a commitment to the procurement of eco-friendly goods by taking this basic policy into account. According to this policy, 267 items are defined as eco-friendly goods. As of 2014FY, Total 72 JIS standards are referred to this policy as test and product standard.

Japanese Policy / Regulation Reference to standard/s

Building Law
Quality of Building Materials

Article 37 :
Such  building materials as wood,  steel, concrete and other materials specified by the Minister of Land, Infrastructure and Transport  used for the foundations, principal building parts,  and other parts  of building specified by Cabinet Order which are important from the viewpoint of safety, fire prevention and sanitation (hereafter in this Article referred to as “designated building materials” shall come under either one of the following items:

Those  qualities conform to the Japanese Industrial Standards or Japanese Agricultural Standards designated for each  designated building materials by the Minister of Land, Infrastructure and Transport.

Enforcement Regulation
of Pharmaceutical Affairs Law

Designated medical equipment that the Ministry of Health Labour and Welfare specifies standards pursuant to the
provisions of Item 1 of Article 23-2 of the Pharmaceutical Law.

Medical equipment

 

Standards

JIS

Purpose of use, effect or impact

Thermometer

T1140

Making temperature measurement section contact, measure the body temperature of rectum, armpit, buccal cavity (hypoglossal), keeps the highest temperature and indicates it digitally

Designated Medical Equipment that the Ministry of Health, Labour and Welfare specifies standards pursuant to the provisions of Item 1 of Article 23-2 of the Pharmaceutical Affairs Law shall conform to the standards given in the table above.

 

Electrical Appliance
and Material Safety Law

Technical requirements pursuant to the provisions of the Ministerial Ordinance Specifying Technical Requirements for Electrical Appliances and Materials.

Technical requirements for electrical applicances and materials

Notes

Number

Title

Text

J60068-2-2(H14)

Basic environmental testing procedures, Part 2: Tests, Test B: Dry heat

JIS C 0021: 1995

Corresponding to IEC 60068-2-2 (1974) Amd. No. 2 (1994)

J60068-2-3 (H14)

Basic environmental testing procedures, Part 2: Tests, Test C: Damp heat, steady state

JIS C 0022: 1987

Correponding to IEC 60068-2-3 (1969)

The harmonized standards are stipulated in Appendix Table 12 of the Interpretation of the Ministerial Ordinance Specifying Technical Standards for Electrical Appliances and Materials, and the Technical Requirements pertinent to each of the relevant products shall be applied..
Basic Policy for the Promotion of Procurement of Eco-Friendly Goods and Services

Item

Evaluation Criteria

Light bulb-shaped lamps

Bulb-shaped LED lamps must meet the following criteria.
a. Average color rendering index Ra of 70 or more.
b. Rated life of at least 40,000 hours.

1. Measuring methods of Average color rendering index Ra is in accordance with light source color and color rendition evaluation method of source of light by JIS C 8152-2(Photometry of white light emitting diode for general lighting-Part 2: LED modules and LED light engines).

2. Rated life of bulb-shaped LED lamps in this section refers to the total amount of lighting time until the initial luminous flux to decrease by 70%. The method of measurements is in accordance with JIS C 8152-3 (Photometry of white light emitting diode for general lighting-Part 3: measurement methods for lumen maintenance).
   
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The South African Bureau of Standards (SABS) is the ISO Member body in South Africa: https://www.sabs.co.za/

The development of voluntary national standards in South Africa is carried out by the South African Bureau of Standards (SABS) the official National Standards Body (NSB), which is authorized to do so in terms of the Standards Act (Act 8 of 2008). This is the third revision of the Standards Act and this revision was done to separate the standards development and conformity assessment functions carried out by the SABS from its regulatory functions which is now covered by Act No. 5 of 2008: National Regulator for Compulsory Specifications Act, 2008 and conducted by the National Regulator for Compulsory Specifications (NRCS).

In terms of South African legal practice, reference to standards in national legislation can declare the voluntary standards as compulsory standards, after this status change the standards are deemed to be readily available to all who might have a need to consult these standards. The development of two types of “Compulsory Specifications” (below  discussed in greater clarity)  are used by the South African regulators, the one being a front end specification referring to South African and / or adopted International standards the other, where the specification reflects all the relevant requirements without any reference to any other document or standard.  

In this Internet age specifications are readily available on the Regulators websites. The supporting standards have however to be consulted or purchased via the South African Bureau of Standards (SABS).  Any legislator in South Africa has the right to incorporate any national standard into legislation under whatever terms and conditions it chooses. Normally the legislator concerned will consult the SABS regarding the implications, and will regulate using standards only in terms of the need to ensure compliance with standards at the point of use of a commodity (for example, in the mining industry it is important to ensure that miners’ head lamps always conform to relevant requirements when in use — not merely when they are purchased new). In some cases, however, where safety, market failures, unfair trade practices, etc.  need  to be prevented, it is necessary to regulate using standards, at the point of sale (for example, all automotive brake  fluid sold in the country is required to conform to relevant standards at all points of sale, including at points of importation, wholesale and retail distribution. This type of regulation is normally the prerogative of the national Department of Trade and Industry, and is achieved through the means of “Compulsory specifications” referred to in Technical Regulation at national, provincial or even at lower levels. A Regulation typically takes one of three forms:

1. Full publication of all technical requirements, including administrative provisions, conformity assessment or deemed-to-satisfy requirements, in legislation per se.  Often this type of regulation will exclude any reference to standards, although for practical reasons the “full publication” route is not used very widely. Modern regulatory good practice, as endorsed by government policies, would favour making use of reference to national standards, where they exist, over the full publication method, but examples of the latter still exist.

2. Reference to national standards under relevant legislation (national or lower level). In this method, a legislator is free to choose under  what conditions of use  it wishes to regulate a commodity, to prescribe appropriate conformity assessment provisions and,  if necessary, to require compliance with deviations from the referenced national standards, where such  are deemed necessary.  In this method, which is the most common, the national standard typically provides the technical requirements for the commodity and the administrative provisions would be given in the regulation. At national level the regulation would typically be published by the applicable government department in terms of an existing Act of Parliament. In this method the national standard, being readily available, is often the most convenient choice for the legislator as the basis for regulation; it can readily be amended to keep up with technology (via the national standards process) and has the benefit that it already represents a national consensus of experts  as to the appropriate level of fitness for purpose (in the case of a physical product).

3. Publication of a “Compulsory specification”.
This is a mandatory standard, applicable to certain products and commodities at their point of sale, and is typically used to regulate safety-critical items where market failures would otherwise occur in the absence of regulation. Examples of the fields covered by compulsory specifications include electrical fittings, food safety, automotive components, etc.

The SABS Standards Division has developed around 80 compulsory specifications (compared to its voluntary national standards base of around 7,000  standards).

A compulsory specification has  historically been developed by a SABS Technical Committee, sometimes initially as a national standard and sometimes as a separate document, and then recommended via the SABS Council to the Minister of Trade and Industry for implementation as a Compulsory Specification. After a public enquiry process, a Compulsory Specification is published in full in the Government Gazette (including provisions for the application of the technical requirements, administrative provisions, etc.). The Compulsory Specification then becomes law in its own right under the Standards Act. It is not a national standard and, typically, is applicable at the point of sale.

South African Policy / Regulation Reference to standard/s

Occupational Health
and Safety Act 85 of 1993

(The example on the right is of direct incorporation of a national standard into legislation by reference in a Schedule to Regulations promulgated in terms of an Act of Parliament, followed by an extract from the actual regulation.)

Incorporation (abridged): “Under section 44 of the Occupational Health and Safety Act,1993  (Act 85 of 1993) I, MMS Mdladlana, Minister of Labour, hereby  incorporate SANS 10019  Code of practice for portable metal containers for compressed gasses’ into the Diving Regulations 2001”

Extract from Diving Regulations 2001:  “The employer must take all reasonable steps to ensure that the air supplied to the divers is pure and that it meets the requirements of SANS 10019.”

National Building Regulations and Building Standards
Act 103 of 1977 (as amended)

Regulations under Section 17 (1), Regulation F5

F5. Soil poisoning

“Where so required by the local authority, the soil in all areas within the site as defined in code  of practice SANS 10124  shall be treated  in accordance with the recommendations of SANS 10124.”

 

Water Services Act 108 of 1997

– Regulations under  sections 9(1) and 73(1)(j)
– Regulation 8 “Use of effluent”, subregulation 8 (3)

 8 (3)

“A notice contemplated in subregulation (2) must  be in more than one official language and must  include the PV5 symbolic sign for non-potable water as described in SANS 1186,  Symbolic Safety Signs : Part 1: Standards, Signs and General Requirements.”

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The American National Standards Institute (ANSI) is the ISO Member body in the U.S.A.: http://www.ansi.org/

Background

 As a signatory of the World Trade Organization, the U.S. is responsible for pursuing standardization activities that are in full compliance with the WTO/ TBT, as this is the key international agreement which mandates how countries use standards and conformity assessment in regulation. Specifically, section 2.4 should be noted as this is one of the key linkages the agreement makes regarding how standards should be used in technical regulations.

2.4 Where technical regulations are required and relevant international standards exist or their completion is imminent, members shall use them, or the relevant parts of them, as a basis for their technical regulations except when such international standards or relevant parts would be an ineffective or inappropriate means for the fulfillment of the legitimate objectives pursued, for instance because of fundamental climatic or geographical factors or fundamental technological problems.
The U.S. federal government is the largest single creator and user of specifications and standards — current estimates point to more than 44,000 distinct statutes, technical regulations or purchasing specifications. Decisions about which standards are most appropriate for U.S. government use are left to the discretion of individual agencies, though recent trends indicate that voluntary consensus standards from both national and international sources are being increasingly referenced by U.S. agencies and regulatory bodies. Add the more than 50,000 standards estimated to come from the private sector in America and the nation’s total inventory of standards quickly approaches 100,000. These documents are produced and maintained by nearly 600 standards organizations in the United States, over 200 of which are accredited by ANSI as developers of American National Standards (ANSs). In addition, the full catalogues of ISO and IEC have the potential to be used or referenced in regulation by U.S. federal government agencies if deemed appropriate.

Standards usage

Government agencies can use externally developed standards in a wide variety of ways, including the following:

  • Adoption: An agency may adopt a voluntary standard without change by incorporating the standard in an agency’s regulation or by listing (or referencing) the standard by title. For example, the Occupational Safety and Health Administration (OSHA) adopted the National Electrical Code (NEC) by incorporating it into its regulations by reference.
  • Strong deference: An agency may grant strong deference to standards developed by a particular organization for a specific purpose. The agency will then use the standards in its regulatory programmer unless someone demonstrates to the agency why it should not.
  • Basis for rulemaking: This is the most common use of externally developed standards. The agency reviews a standard, makes appropriate changes, and then publishes the revision in the Federal Register as a proposed regulation. Comments received from the public during the rulemaking proceeding may result in changes to the proposed rule before it is instituted.
  • Regulatory guides: An agency may permit adherence to a specific standard as an acceptable, though not compulsory, way of complying with a regulation.
  • Guidelines: An agency may use standards as guidelines for complying with general requirements. The guidelines are advisory only; even if a firm complies with the applicable standards, the agency may conceivably still find that the general regulation has been violated.
  • Deference in lieu of developing a mandatory standard: An agency may decide that it does not need to issue a mandatory regulation because voluntary compliance with either an existing standard or one developed for the purpose will suffice for meeting the needs of the agency.

Where standards are referenced in regulations, regulatory policies emphasize that regulations (including any referenced standards) be cost- effective, consistent, sensible and understandable, and that the regulatory process should be open, transparent and fair to all interested parties. Government regulations may address health, product safety, operator/user safety, environmental effects, quarantine requirements, consumer protection, packaging and labelling, product characteristics, or other matters in the public interest.

Legislation

Federal policy regarding the use  of standards and conformity assessments is contained in certain key provisions of the National Technology Transfer and Advancement Act (NTTAA) (Public Law 104-113), signed  into law in early 1996.  The NTTAA requires that:

  • all Federal agencies and departments shall use technical standards that are developed or adopted by voluntary consensus standards bodies, using such  technical standards as a means to carry out policy objectives or activities determined by the agencies and departments except  where such  usage would be inconsistent with applicable law or otherwise impractical, and that
  • Federal agencies and departments shall consult with voluntary, private sector, consensus standards bodies and shall, when such participation is in the public interest and is compatible with agency  and departmental missions, authorities, priorities and budget resources, participate with such  bodies in the development of technical standards.

Office of Management and Budget (OMB) Circular A-119, Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities, provides federal agencies with guidance on how to implement these requirements in the NTTAA.

Other laws and policies that reinforce the strong public-private partnership approach to standards and conformity assessment in specific sectors or areas of interest include the following:

Standards Development Organization Advancement Act of 2004 (H.R. 1086)

HR 1086 provides qualified standards developers with an opportunity to file for, and obtain, a limited exclusion from antitrust liability for treble damages. This protection is identical to the protection which has been available to joint ventures under the National Cooperative Research and Production Act since 1993, which also remains available to those utilizing a consortium or other informal processes to develop standards.

The Consumer Product Safety Act

Under the Consumer Product Safety Act, the Consumer Product Safety Commission specifically relies upon voluntary consensus consumer product safety standards rather than promulgate its own standards. The relevant portion of the law is set forth below:
“...The Commission shall rely upon voluntary consumer product safety standards rather than promulgate a consumer product safety standard prescribing requirements described in Subsection (a) whenever compliance with such voluntary standards would eliminate or adequately reduce the risk of injury addressed and it is likely that there will be substantial compliance with such voluntary standards.” (Source: Section 7(b) (1) of the Consumer Product Safety Act (15 USC 2056; PL 92-573; 86 Stat.  1207, Oct. 27, 1972, as amended in 1981.)

The Health Insurance Portability and Accountability Act of 1995

This Act requires the Secretary of Health and Human Services to adopt standards developed by ANSI-accredited standards developers whenever possible.

The Telecommunications Act of 1996

The first major overhaul of U.S. telecommunications law in almost 62 years, the act contains several provisions that propel the Federal Communications Commission (FCC) toward reliance upon private sector standards. In particular, the FCC is seeking to ensure that the standards development process in the telecommunications area is open and consensus- based — the very things provided for by ANSI accreditation requirements.

The Food and Drug Administration (FDA) Modernization Act of 1997

This act contains provisions which allow the FDA in some instances to accept manufacturers’ declarations of compliance to certain standards during the evaluation of pre-market submissions for electrical medical devices. This is expected to result in a substantial reduction of time-to-market for some medical devices while still ensuring that fundamental regulatory health and safety responsibilities are met.

Procurement reform

In addition, the U.S. Government has increased its reliance on private sector standards in its procurement activities. In 1994, Secretary of Defense, William Perry, announced that one of the Department of Defense’s (DoD’s) top priorities would be to move away from military-unique specifications and standards (milspecs) and toward  reliance upon private sector  standards to ensure  that DoD continued to meet  its military, economic and policy objectives in the future in a cost-effective manner.

Summary

The United States considers standards to be a fundamental factor in the nation’s economy and vital to world commerce. Within the United States, standards are developed through a complex but effective system administered by the private sector, with the participation of industry, academia, consumers and government. The U.S. system has evolved over the last 100 years to meet the needs of U.S. industry and society in general. Rooted in the private sector, it has successfully met domestic marketplace needs on a sector-by-sector basis. Responsibility for coordination of the U.S. private sector standards system rests with the American National Standards Institute (ANSI). ANSI is also the U.S. member body within ISO and IEC. Organizations that are accredited by ANSI to develop American National Standards (ANSs) or to serve as U.S. Technical Advisory Groups (U.S. TAGs) to the International Organization for Standardization (ISO), or organizations that are approved by ANSI’s U.S. National Committee (USNC) of the International Electrotechnical Commission (IEC) to serve as U.S. TAGs to IEC committees, are required to adhere to a set of essential requirements that are aligned with the WTO principles. These principles include transparency, openness, impartiality, effectiveness and relevance, consensus, performance-based coherence, due process, and the provision of technical assistance where appropriate. The U.S. system, both domestically and internationally, benefits from strong  industry support and participation of both government and private sector  technical experts  as equals at all levels in the process.

U.S.A. Policy / Regulation Reference to standard/s

47 CFR 15.109
Federal Communications
Commission

Part 15_Radio frequency devices
Subpart b Unintentional radiators

Sec.  15.109 Radiated emission limits.

g) As an alternative to the radiated emission limits shown  in paragraphs (a) and (b) of this section, digital devices may be shown to comply with the standards contained in the Third Edition of the International Special Committee on Radio Interference (CISPR),
Pub.  22,“Information Technology Equipment — Radio Disturbance

Characteristics — Limits and Methods of Measurement”.

10 CFR 73.26
Nuclear Regulatory Commission

Part 73_Physical Protection of
Plants And Materials

Sec.  73.26 Transportation of physical protection systems, subsystems, components, and procedures.

(l) Shipment by sea.  (1) Shipments shall be made only on container-ships.

The ANSI Standard MH5.1 (1971) and the (ISO) 1496 (1978) have been approved for incorporation by reference by the Director of the Federal Register. A copy of each of these standards is available for inspection at the NRC Library, 11545 Rockville Pike, and Rockville, Maryland 20852-2738.

 

 46 CFR 111.105-11 Title 46 — Shipping Chapter  I — Coast  Guard,  Department Of Homeland Security

Part 111_Electric Systems — General Requirements
Subpart 111.105_Hazardous Locations
Sec.  111.105-11 Intrinsically safe systems.

 

Sec.  111.105-11 Intrinsically safe systems.

(a) Each system required under this subpart to be intrinsically safe must use approved components meeting UL 913 or IEC 79-11.

 

47 CFR 15.109(g)

As an alternative to the radiated emission limits shown in paragraphs (a) and (b) of this section, digital devices may be shown to comply with the standards contained in Third Edition of the International Special Committee on Radio Interference (CISPR), Pub.  22, “Information Technology Equipment — Radio Disturbance Characteristics — Limits and Methods of Measurement” (incorporated by reference, see §15.38). In addition:

(1) The test procedure and other requirements specified in this part shall continue to apply to digital devices.

(2) If, in accordance with §15.33 of this part, measurements must  be performed above  1000  MHz, compliance above  1000  MHz shall be demonstrated with the emission limit in paragraph (a) or (b) of this section, as appropriate. Measurements above  1000  MHz may be performed at the distance specified in the CISPR 22 publications for measurements below 1000  MHz provided the limits in paragraphs (a) and (b) of this section are extrapolated to the new measurement distance using an inverse linear distance extrapolation factor
(20 dB/decade), e.g. the radiated limit above  1000  MHz for a
Class B digital device is 150 up/m, as measured at a distance of
10 meters.

(3) The measurement distances shown in CISPR Pub.  22, including measurements made  in accordance with this paragraph above
1000 MHz, are considered, for the purpose of §15.31(f) (4) of this part, to be the measurement distances specified in this part.

(4) If the radiated emissions are measured to demonstrate compliance with the alternative standards in this paragraph, compliance must also be demonstrated with the conducted limits shown in §15.107(e).

Note: CISPR is a Committee within the IEC.
47 CFR 15.31(a)(3)

Other intentional and unintentional radiators are to be measured for compliance using the following procedure excluding
Sections 4.1.5.2, 5.7, 9 and 14: ANSI C63.4-2003: “Methods of Measurement of Radio-Noise Emissions from Low — Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz” (incorporated by reference, see §15.38). This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.

Note to paragraph(a)(3): Digital devices tested to show  compliance with the provisions of §§15.107(e) and 15.109(g) must  be tested following the ANSI C63.4  procedure described in paragraph (a)(3) of this section.