We live in a fast-changing world, and companies selling products globally are subject to ever expanding regulations both at home and abroad. Staying abreast and assuring compliance is more challenging than ever for electronics distributors, manufacturers, and suppliers.
Most regulations affecting electronics restrict the use of harmful substances, and there have been significant global changes over the past 12 months:
* a new RoHS (recast) rule has taken effect in the European Union (EU) on January 2
* 68 new substances of very high concern were added to the EU REACH list in 2012
* a conflict minerals reporting rule was promulgated and took effect in the USA
* pressures on medical product producers in the USA and Canada to limit the use of BPA, DEHP, and latex in their products continued
* rules are soon be enacted requiring U.S. defense electronics suppliers to detect and prevent counterfeit parts use
* chemical substances are under review in Canada for possible restrictions under the Canadian Environmental Protection Act (CEPA)
* chemical substance restrictions are expected in the USA under the Toxic Substance Control Act and California’s Green Chemistry program
* new China RoHS rules were drafted
* India RoHS and WEEE rules took effect.
We will take a global tour of each one now. Please note that comprehensive information is continually updated and available at no charge at Newark’s element14 engineering community (www.element14.com/legislation), as well as guidance from a network of legislation specialists.
EU RoHS Recast (RoHS 2)
The EU’s original RoHS directive forever changed the electronics industry. It restricted the use of six hazardous substances and has resulted in safer electronic goods. This EU directive was so successful that China, Japan, South Korea, Taiwan, India, Norway and the State of California have followed the European Union's lead and enacted their own RoHS laws.
On January 2, 2013, a new upgraded RoHS directive with wider scope and more restrictions took effect. This version is known as RoHS recast (or RoHS 2). It expands coverage (over time) to all electrical and electronic equipment, requires CE marking of RoHS regulated “finished goods”, requires manufacturers to provide more compliance documentation, and increases penalties for non-compliance.
The original RoHS regulations covered only 8 of 10 defined categories of electronics (RoHS product categories 1 through 7 and 10). It also granted exemptions for a number of products.
The goal of the new RoHS 2 regulation is to address all categories of electronic equipment by 2019 or sooner. Exemptions will be phased out, the two categories not currently covered will be phased in, and a new category 11 will be added covering all remaining electronic products.
The timetable for covering additional products is as follows:
* July 2014 – Categories 8 (medical devices) and 9 (consumer monitoring/control instruments)
* July 2016 – In-vitro diagnostic medical devices.
* July 2017 – Industrial monitoring/control instruments.
* July 2019 – Category 11 (all other EEE not previously covered).
The following requirements affecting already covered products took effect on January 2:
* manufacturers must provide updated (RoHS 2) declarations of compliance;
* manufacturers must provide (on request) technical documentation of RoHS 2 compliance;
* finished goods manufacturers must also assure CE mark compliance;
* components, spare parts, and cables used in the manufacture, repair or upgrade of a covered product must be RoHS 2 compliant; and
* general purpose equipment (like semiconductor development kits) that simply plug into other equipment to make them work are considered finished goods and (unless currently exempt) must be both RoHS 2 and CE mark compliant.
The liability for RoHS non-compliance has increased. Violations of CE mark and technical file requirements can result in fines and product being withdrawn from sale.
There is a RoHS 2 provision that allows the EU to restrict additional hazardous substances in the future. Four new priority substances are to be considered in July 2014 (using the REACH methodology for substance restriction).
In summary, the requirements have gotten tougher. If a product isn't currently covered, RoHS 2 ensures it eventually will be. Non-compliance liability has increased so you can't afford to be non-compliant.
Under REACH, substances with one or more of the characteristics listed are routinely reviewed by an EU agency (ECHA) to determine if they require designation as a REACH substance of very high concern:
* carcinogenic, mutagenic or toxic to reproduction (CMRs);
* persistent, bio-accumulative and toxic (PBTs);
* very persistent and bio-accumulative (vPvBs);
* seriously and / or irreversibly damaging the environment or human health, as substances damaging the hormone system;
The number of substances of very high concern (SVHCs) covered under REACH has continued to increase. New substances are being reviewed and added every six months. There were 68 new SVHCs added in 2012. The total number on the REACH candidate list now totals 138.
Suppliers of products containing SVHCs are required to inform users of the presence of an SVHC at a concentration of greater than 0.1% by weight. The burden on manufacturers, suppliers, and distributors to collect data on new substances every six months (when new SVHCs are added) remains large.
The US Securities and Exchange Commission (SEC) issued their long awaited conflict minerals rule as required per Section 1502 of the Dodd Frank Financial Dodd-Frank Wall-Street (Financial) Reform and Consumer Protection Act. The aim of the rule is to stop companies from sourcing minerals from regions in the world where armed conflict and human rights abuses are occurring, and armed rebel groups perpetuating the conflict/abuses are profiting from it. The region specifically targeted in the rule is the Democratic Republic of Congo (DRC) and surrounding region.
The new rule requires SEC registered companies to annually determine if any tin, tantalum, tungsten, or gold (and their derivatives) was added to/used in their products. If so, they must conduct a reasonable country of origin inquiry (RCOI) to determine whether the mineral(s) used came from a conflict-free source (i.e. from outside the DRC region or from a conflict free smelter located in the DRC region). Affected companies must annually report the results of their RCOI to the SEC.
SEC registered companies must:
* audit their supply chains to verify the source of any tin, tantalum, tungsten, or gold (and their derivatives) in products supplied to them, and (if present)
* identify the smelters used and whether the minerals were sourced from the DRC region.
If a company determines any minerals used were sourced from the DRC region, they must submit to the SEC a Conflict Minerals Report (CMR) detailing the methods, extent and results of their inquiry. The CMR report must be audited by an independent private sector auditor.
Companies must submit their first annual disclosure report to the SEC on May 31, 2014. It must cover conflict minerals usage in 2013. If a CMR is required, it must be submitted as well.
Companies are allowed a two-year phase-in period to deal with any suppliers unable to provide needed information. During this time companies may report “DRC conflict undeterminable”.
Medical product producers in the USA and Canada continue to be pressured to limit the use of BPA, DEHP, and latex in their products. Producers are increasingly being asked to identify if these substances are present (and to eliminate these substances if present) in products sold in the U.S. and Canada.
Both DEHP and BPA are EU REACH SVHCs. Allergic reactions to latex are the reason medical product producers in the USA and Canada are also being asked to restrict latex use.
Canada’s Bill C-307 required Health Canada to produce a list identifying all medical devices sold in Canada containing ? 0.1% w/w of DEHP or any BPA in any concentration. All Canadian manufacturers of licensed Class II, III and IV medical devices are required to inform Health Canada as to whether their devices contain more than or equal to 0.1% by mass of DEHP or are manufactured from raw materials containing or derived from BPA. That is the reason Canadian medical product producers and suppliers have been asked declare whether these substances are present in their products.
The U.S. Food & Drug Administration (FDA) last summer agreed to ban DEHP and BPA from baby bottles and children’s drinking cups but stopped short of a broader ban covering all plastic bottles and food packaging. Still, the pressure is on producers and suppliers to identify the presence and discontinue use of these controversial substances.
Counterfeit parts are appearing in electronic products at an alarming rate. Counterfeiters are taking scrap components (like semiconductors and transistors), sanding off part numbers and other identifying marks and recoating the parts to hide the sanding marks. The parts are then being relabeled and sold as new parts. These parts typically have short life spans and fail in service.
The U.S. defense industry is particularly vulnerable as they often rely on military and commercial-grade “obsolete parts” to maintain long-life military equipment. A military part may be manufactured for only a couple years, while the equipment it is used in may remain in service for 20 years or more.
An amendment to the 2012 National Defense Authorization Act addressed the problem. Defense contractors will soon be required to establish systems for detecting and avoiding the use of counterfeit parts. Contractors who fail to do so will be required to absorb the costs of fixing problems caused by counterfeit parts. In addition, the Department of Defense was told to adopt policies and procedures for detecting/avoiding counterfeit parts. Federal regulations governing counterfeit parts were expected in 2012 but have been delayed until early in 2013.
Chemical substances under review in Canada for possible restrictions
On December 8, 2006, Canada established a Chemicals Management Program (under the Canadian Environmental Protection Act or CEPA). The goal is to regulate chemicals potentially harmful to human health or the environment. A key element in the Chemicals Management Program is to collect mandatory information from industrial producers on the properties and uses of approximately 200 chemical substances that have been identified as high priorities for action. The government has been working on the list sequentially and requests have been being sent out every 3 months. They are still sending out requests and collecting information.
The information collected is used to make decisions regarding the best approach to protect human health and the environment from any risks these high priority substances pose. This initiative is known as the "Challenge".
Substances of concern to the electrical and electronics sector that are currently being reviewed include: PBDEs, PFOS (perfluorooctane sulfonate), BPA and mercury (Hg). Industrial producers preparing responses to requests for information often in turn send requests for information to their suppliers.
Chemical substance restrictions are expected in the USA under the Toxic Substance Control Act and California’s Green Chemistry program
The USA Toxic Substances Control Act was not amended in 2012 as expected, probably because it was a Presidential election year and controversial changes of this year are typically delayed until a new Congress is elected. We can expect legislation to be introduced in 2013.
California’s green chemistry program update
California adopted its’ Green Chemistry law in 2008 because consumers wanted assurances of safety, and industry wanted a science-based and predictable process for examining chemical ingredients. It is an EU REACH type law that allows California to study and restrict hazardous substances in consumer products.
Proposed regulations were issued in July and the comment period just closed. No word yet on what changes will be made before final regulations are issued.
Using a world-wide recognized list of “chemicals of concern” the proposed regulation would create a process by which manufacturers who are using one of those listed chemicals must identify and examine the viability of safer ingredients. If an alternative is not feasible, the California Department of Toxic Substances Control (DTSC) will identify steps the manufacturer must take to ensure the product is safely used, disposed of, or phased out. The regulation also provides consumers with enhanced information about product ingredients. For more information on the proposal visit: www.dtsc.ca.gov/SCPRegulations.cfm.
Asia - China RoHS
China RoHS made some headway in 2012. On June 7 the Chinese Ministry of Industry and Information Technology (MIIT) published draft Measures for Administration of the Pollution Control of Electronic and Electrical Products (referred to as new China RoHS). The old measures issued in 2006 will be revoked once the new measures enter into force.
As for the changes, hazardous substance restrictions in electrical and electronic equipments and their packaging materials remain the same. However, there are changes (a change of product scope, new labeling requirements and a flexible certification mechanism) that companies will need to comply with before placing electronic and electrical products on the Chinese market.
India RoHS and WEEE
The Indian Government in 2011 published legislation on the disposal of waste electrical and electronic equipment, and what is referred to as “reduction in the use of hazardous substances.” The India “e-waste (Management and Handling) Rules 2011” took effect on May 1, 2012.
Whew. That was a whirlwind tour, but we hope you now have a better sense of what your responsibilities are before you distribute, supply or manufacture an electronics-based product at home or abroad.