UNDERSTANDING GLOBAL CONFORMITY ASSESSMENT AND LOCAL APPROVAL FOR EEE

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1 Author Barbara Wert Regulatory Compliance Specialist

2 EXECUTIVE SUMMARY Before Electrical and Electronic Equipment (EEE) can be placed on any market, it must meet all applicable legislative requirements. These requirements often necessitate a local approval requirements. Conformity assessment schemes minimize the cost and time of product testing; however, knowing all of the many aspects to consider, such as proper documentation, product marking, language requirements and registration. Further, more countries are implementing multiple environmental regulations for IT equipment, and meeting these requirements may mean separate testing, documentation, application and/or registration, and product marking. This white paper will: assessment and conformity assessment schemes Explore regional and national approval requirements for IT equipment Look at the multiple aspects of environmental Suggest resources for meeting the challenges of Provide a snapshot look at current requirements for safety, EMC, and environmental compliance around the world INTRODUCTION Preparing a new product for global market access is a complex and challenging task. EEE is one of the areas most effected by what the World Trade Organization calls technical trade barriers, and the multi-tiered process of certifying a product to all relevant legislation in multiple markets almost always involves multiple assessment bodies and international regulatory resources. To avoid delays in market access, manufacturers should be aware of the requirements and procedures to achieve product approvals in desired locations, as well as the resources CONFORMITY ASSESSMENT Conformity Assessment. Conformity Assessment is the set of criteria (usually, technical standards ). Evaluation can focus on one or more regulated characteristics, depending on the product set. Regulated characteristics include electrical safety, consumer protection, electromagnetic compatibility, telecommunications, and environmental impact. Special evaluations are required for equipment intended for explosive or otherwise hazardous atmospheres. THE CRITERIA for a technical system, such as EEE. Standards include criteria for the engineering of a product, and required methods and measurements (metrology) for testing the product. Standards Organizations and Standards Bodies can be international, regional, or national in scope. ISO (International Organization for Standardization), IEC (International Electrotechnical Commission), and ITU (International Telecommunication Union) are among the most widely recognized international standards organizations. CENELEC (European Committee for Electrotechnical Standardization) is an example of a regional standards organization, and Bureau of Indian Standards (BIS) and Korean Agency for Technology and Standards (KATS) are among the many national standards developing organizations such as IEEE (Institute of Electrical and Electronics Engineers). THE BENEFITS The National Institute of Standards and Technology (NIST) recently published Special Publication ABC s of Conformity Assessment (1), which states that conformity assessment can assure that a particular product, service, or system meets a given level of quality or safety, and provide explicit information about its characteristics, the consistency of those characteristics, performance, and/or adherence to regulatory requirements. This involved in the manufacturing and distribution of a product.

3 consistent in quality and function when used as intended. CONFORMITY ASSESSMENT BODIES Manufacturers typically bring their products to test labs, formally referred to as Conformity Assessment Bodies In the USA, test labs may or may not be nationally recognized. Nationally Recognized Test Labs (NRTL s) are acknowledged by the Occupational Safety & Health Administration (OSHA) to provide safety evaluation, testing, and available at Test labs are regulated and audited by accreditation agencies, such as A2LA (American Association for Laboratory Accreditation), Industry Canada, and UKAS (United Kingdom Accreditation Services). Accreditation agencies use labs. INTERNATIONAL CONFORMITY ASSESSMENT SCHEMES Conformity assessment schemes (CAS) provide a single point of product evaluation, and, through mutual acceptance of one common set of standards ( harmonized standards ) and test reports, result in lessening technical trade barriers. With CAS, producers can see substantial savings in the cost and time of getting a product to multiple markets. Probably the most widely recognized international conformity scheme for the safety of EEE, the IECEE CB Scheme Another widely recognized CAS is CE (Conformité Européene). The European scheme encompasses product directives and standards that cover the areas of low voltage, EMC, radio equipment, restriction of hazardous chemicals, energy marking on applicable EEE. Conformity and EAC mark are required in Armenia, Belarus, Kazakhstan, Kyrgyzstan, and the Russian Federation. Gulf Technical Regulations for low voltage equipment and EMC include the requirement for the relatively new G Mark on equipment included in published scope documents. Gulf Member States include Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates (UAE). There are additional national requirements for several of the Gulf Member States.

4 LOCAL APPROVALS While CAS test reports validate a product s conformity to recognized international standards, most countries have unique approval systems. Along with the submission of the CAS test reports, there are usually additional steps needed to achieve the local approvals. THE REQUIREMENTS Applications and fees Equipment samples On-site factory audits Operator manuals and safety information and labelling in the local language Local licensed trade representative CERTIFICATION AND PRODUCT MARKING renewal on an annual or multi-annual basis. DOCUMENT AND APPLICATION SUBMISSION Many test labs will assist with global market access, including coordination to meet any national deviations from IEC requirements, and application submission to the appropriate regional or national regulatory authorities. Another method of application and document submission is through national web-based registration systems, such as Saudi Arabia s SABER and the UAE s ECAS product registration database, both of which are still works in progress. ON-SITE FACTORY AUDITS Countries such as India and China require factory authorization, including periodic on-site audits of the manufacturing LANGUAGE REQUIREMENTS Many regions and countries require product documentation and/or labelling be provided in the local language. for safety information and instructions to be provided in each EU member states local language. Additionally, upon reasoned request from a competent national authority (2) the local language. Other localities with language requirements include Argentina, China, the Gulf States, Hong Kong, Korea, Mexico, Peru, Russia, and Uruguay.

5 ENVIRONMENTAL SCHEMES There has been a widespread increase in regulating the environmental impact of EEE on the global market. Legislation and electronic waste disposal has resulted in environmental assessments such as RoHS and REACH, and additional producer responsibilities for energy and waste management. ROHS RoHS around the world has been a major focus for many regulators and manufacturers as of late. RoHS is the Restriction of Hazardous Substances which concerns minimizing the use of certain substances in IT equipment. Currently there are six regulated substances: RoHS legislation is also in place in China, EAEU, India, Korea, UAE, Singapore, Taiwan, Thailand, Turkey and Vietnam, with pending legislation in Brazil and the GCC. While the same substances are regulated in each of these regions, there may be variances in scope, exemptions, and reporting requirements. Some of the newer RoHS legislation, such as Taiwan and UAE, requires product marking and/or in-country REACH Cadmium Hexavalent chromium Lead Mercury Polybrominated biphenyls (PBB) additional phthalates will be restricted as well: Butylbenzyl phthalate (BBP) The Registration, Evaluation and Authorization of Chemicals (REACh) regulates a much larger number of chemicals. The on the list. The SVHC list is updated, often multiple times during a year, and each update necessitates action for the providers to ensure continued compliance. South Korea s K-REACH involves the registration of new chemicals and reporting requirements based on tonnage

6 ECO DESIGN AND ENERGY EFFICIENCY for annual total energy consumption, mandate sleep mode, and mandate energy consumption in stand-by and off modes. Energy labelling is also required in many areas. Some programs, such as Australia s GEMS (Greenhouse and Energy Minimum Standards), impose fees for products in scope of registration with the local environmental agency. WEEE Electronic waste (e-waste) is one of the fastest-growing global waste streams. E-Waste regulations are being adopted waste is not properly managed it can cause environmental and health concerns. interchangeably to refer to other e-waste regulations. Many WEEE programs include elements of Extended ucer Responsibility, or, EPR. The EPR scheme requires manufacturers to be responsible for the environmental protection standards throughout the product lifecycle. Responsibilities can include registering with the region s environmental protection agency, paying annual fees for EEE placed on the region s market, and recycling or takeback of EEE when it reaches end of life. BATTERY MANAGEMENT markets, such as the composition, transport, and disposal requirements for the particular type of battery in the product. Some legislation places limits on mercury alone, while others place limits on mercury, cadmium, and/or lead. Some locations require documentation such as the safety data sheet for the battery, while other programs, such as India s ewaste Management and Handling Rules, mandate registration by the producer or importer of certain types of batteries. uct marking is required in several countries, including Japan and Taiwan, to indicate the need to recycle KNOW THE LANDSCAPE Achieving global market access necessitates knowledge of the comprehensive set of requirements needed for each market, and coordination of the various services and resources needed to meet each set of requirements. Below are top-level snapshots of requirements for market access to a handful of regions: EUROPEAN UNION: Low Voltage Directive EMC Directive RED Directive RoHS 2 Directive, and REACH Eco-Design Directive WEEE Directive EU Battery Directive

7 EUROPEAN UNION: Factory Language Requirements Local Rep Certificate(s) Regis. sample marking audit No No CE, WEEE No Safety information and manual in local language. DoC in local language upon reasonable request from authority No EU Declaration of Conformity (self-declaration based on product testing to CE Directives and Standards) REACH Declaration Battery Declaration CANADA: Accredited CB listing ICES-003 ISED Telecom Act Mercury Ban EnerGuide labelling (VI) Per province Call2Recycle (rechargeable batteries) Regis. sample marking No No NRTL ICES-003 Language Requirements Local Rep Certificate(s) Factory audit No English or dual English/French No NRTL ICES SOUTH KOREA: KATS (Use CB Scheme) Regis. KATS (Use CE test reports) sample marking RRA Korean RoHS KEMCO "e-standby" and MEPS Act on the Promotion of Saving and Recycling of Resources (2008) Factory audit Yes No KC No Certain manuals required in Korean language RUSSIA: Language Requirements Local Rep Certificate(s) No KCC, KC, e-standby, Korean RoHS K62133 EAC (Use CB scheme) EAC (Use CE EMC test reports) RF Law EAEU RoHS (3/1/2020) Resolution No. 2491/2015 Regis. sample marking Factory audit Language Requirements Local Rep Certificate(s) Yes Yes EAC Yes Russian or dual English/Russian Yes EAC, FSTEC for products with crypto features, Russia Telecom

8 UNITED ARAB EMIRATES: ECAS (Use CB scheme) / GSO TR GSO TR TRA Registration / Approval UAE RoHS None for EEE ewaste regulations are in development Regis. sample marking Factory audit Language Requirements Local Rep Certificate(s) Yes Yes "G", ECAS No Dual Arabic/English Yes SDoC Quality mark (voluntary) also provide material testing and other services related to environmental compliance; however, many do not. Reaching out to regional regulatory and environmental agencies is perhaps the most reliable way to clarify requirements for importing EEE. For example, in the European Union, one can reach out to the European Commission, CENELEC, or ECHA (European Chemicals Agency); in Canada, one can reach out to Environment and Climate Change a matrix of regulatory and environmental agency contacts for each targeted market can save time and effort when CONCLUSION that, From a global conformity assessment service provider s perspective there is a need for global solutions that will reduce inconsistencies from one region to another. The summary further states, The concern for this issue of course goes well beyond the conformity assessment service providers and impacts the product manufacturers and suppliers and ultimately the consumers themselves. The more the EEE manufacturer knows about the complicated process of meeting all conformity assessment and local access, putting in the time and effort to chart the requirements for the different regions can produce an invaluable resource. REFERENCES (1) (2)

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