Original Equipment Manufacturers (OEM’s) are constantly demanding full material disclosures on hazardous substances (FMDs), Declarations of Conformity (DoCs), Certificates of Conformity (CoCs) and/or test data that the part numbers meet the required RoHS or REACH requirements. This is the method by which most OEM’s declare compliance for their finished product.
Several countries globally are implementing Restriction of Hazardous Substances (RoHS) regulations and REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) regulations in order to restrict the use of harmful chemicals and toxins in their electrical and electronic products.
Regions that have stringent rules at this time include:
- European Union / RoHS Directive
- China / Administration of the Control and Electronic Information Products or commonly referred to as China RoHS
- Korea / Administration of the Control and Electronic Information Products
- California / (Electronic Waste Recycling Act of 2003)
- and more….
Products intended to be marketed or sold in Europe MUST
comply with REACH and RoHS regulations.
What is RoHS?
RoHS is the EU Directive that restricts the use of certain hazardous substances in electrical equipment and electronic products (EEE products), including components and/or sub-assemblies.
Who does RoHS affect?
Any business that uses any of the restricted materials and plans to sell its products in RoHS countries, through any sales channel (direct, distributor, integrator, reseller etc.), is affected by the RoHS Directive. Failure to comply with the RoHS regulations can result in severe fines and could result in immediate removal of product from the EU marketplace.
Since 2004, the EU legislation restricts the use of hazardous substances in electrical and electronic equipment (RoHS Directive 2002/95/EC) and promotes the collection and recycling of such equipment (WEEE Directive 2002/96/EC). Products placed on the EU market as of July 1, 2006 must pass the RoHS Compliance.
The objective of the legislation was also to increase the recycling and/or re-use of such products and restrict the use of heavy metals like lead, mercury, cadmium, and hexavalent chromium, as well as flame retardants such as polybrominated biphenyls (PBB) or polybrominated diphenyl ethers (PBDE).
In 2011, the EU amended the RoHS scope, also known as RoHS2. The recast European RoHS Directive (2011/65/EU), restricts the use of certain hazardous substances in electrical and electronic equipment. The recast directive repealed the Directive 2002/95/EC with effect from 1 July 2011. The EU has also released an exemptions update, allowing the use of some of the restricted chemicals for specific purposes. (Click here to read more)
RoHS II is also a CE Mark Directive, effective January 2, 2013 and the transition is expected to be complete in 2019. The directive applies to products that are “dependent on electric current or electromagnetic fields for at least one intended function”.
- Technical testing and accompanying documents
- A declaration of conformity
- CE marking affixed to the product.
Similar to the RoHS requirements, the EU REACH regulation is also mandatory for products being exported to Europe.
What is REACH?
Registration, Evaluation, Authorization and Restriction of Chemicals or REACH is considered to be the strictest law to date regulating the use of chemical substances. REACH is a European Community safety regulation that implies that "no data, no market" companies can only launch their products on the market or use them if these chemicals are properly registered. EU REACH started its 10 year, phased implementation on June 1, 2007. The current REACH regulation for “articles” includes 155 substances of very high concern (SVHC’s). For a complete list, please click here.
One of the major elements of the REACH regulation is the requirement to communicate information on chemicals throughout the supply chain. The REACH regulations affect manufacturers, importers, downstream users and companies established outside the EU. The end use of chemicals affect various industries from consumer goods to personal care to industrial use. Here is a short list of some other industries affected:
- Chemical Industry
- Petroleum Processing
- Plastics Processing
- Engine/Plant Production
- Fine Mechanics
- Sports Equipment
- Leather and Drapery
The European Chemicals Agency has set three major deadlines for registration of chemicals:
- December 1 2010 - 1000 tons/year
- June 1, 2013- 100 tons/year
- June 2, 2018 - 1 ton/year
Pre-registration is the process for potential EU registrants to inform the European Chemicals Agency (ECHA) of their intent to register phase-in chemical substances. The EU REACH Pre-Registration initially took place between June 1 and December 1, 2008, during which time about 143,000 chemical substances marketed in the European Union were pre-registered. The pre-registration was later extended to potential registrants who manufacture or import a phase-in substance in quantities of one ton per year or more to benefit from the extended deadlines. Click here to read our blog on this topic.
Similar to RoHS, even if you don't do business in Europe, you are not off the hook. Following the EU regulation, countries such as China, Malaysia, Japan, and Turkey have already implemented REACH-like legislation. Several other countries are following suit including South Korea which will unveil its REACH regulation “K-REACH” in January 2015.
TÜV Rheinland’s Green Solutions Goes to Work for You
REACH and RoHS compliance poses a big challenge for most companies and requires extensive and specific technical competence and knowledge.
We want to be your partner in ensuring your materials and parts are in compliance. We will assist you with risk assessment of materials, identifying potential high risk materials requiring testing and/or help with validating DOCs and CoCs. Our test lab in North America is ISO 17025 approved through A2LA, accredited for many types of material and product testing and is located in Bentonville, Arkansas.
We employ RoHS, REACH, CPSC, WEEE and other legislation experts that can assist you with your educational needs as well as consult on compliance requirements and solutions. To learn more click here to download our complete brochure or our handy infographic!
Boston recently played host to an international crowd of innovators, public officials, patient groups, academics and entrepreneurs with a vested interest in Connected Health. They gathered at the 5th EU-US eHealth Business Marketplace & Conference held at the Boston State House on October 21-22.
The conference focused on innovations in e-Health, IT Health and Connected Health, a model for healthcare delivery that uses technology to provide healthcare remotely. The theme was “Transforming Care and Accelerating Economies.”
TÜV Rheinland’s Geoffrey Bock and OpenSky’s Mark Coderre attended the conference to learn from the international leaders in Connected Health and share their own expertise as part of the panel on “Medical Device Suite of Standards – to What Degree Does Regulation Help or Hinder Innovation?”
Coderre discussed the ever-increasing need for cybersecurity in embedded in the development lifecycle and final product for medical devices. He also reviewed and acknowledged the importance of the principles laid out in the FDA's guidance in the United States. Bock explained the need for risk assessments that help OEMs meet the standards applicable to the current EU Directives.
“Regulations, standards, risk assessments and due-diligence all help keep patients, doctors, clinics and insurance companies safe when they accept new and innovative devices that might pose high risk precisely because they are so groundbreaking,” summarized Bock.
The conference provided workshops, networking with IT Health professionals, and the chance to establish new business relationships in pre-arranged matchmaking sessions. The partnership between Ireland and the US is particularly promising and was highlighted through a direct “Sister City” relationship between Belfast, Ireland, and Boston.
“It was great to see how many countries were present at this show, and the relationship that Boston has with Belfast was clearly evident through the number of representatives,” said Bock. “It was a great message to other countries that working together across the Atlantic is not only possible but very rewarding.”
The “Shark Tank” session, which allowed innovators to present their ideas in search for funding, showcased some unique offerings, most of which, used phones, tablets and apps to provide the new product, confirming the trend toward using Wi-Fi, 3G/4G and Bluetooth technologies in medical innovations.
To learn more about testing of Connected Health devices, email TÜV Rheinland at info@ tuv.com.
On November 28, 2013, a list of Machinery Directive harmonized standards was published in the Official Journal of the European Union (OJ). These harmonized standards provide a presumption of conformity to the Machinery Directive 2006/42/EC and the new list of standards supersedes all previous versions. The list of standards was further divided into A-type, B-type and C-type standards.
Outdoor power equipment manufacturers, designers, distributors and retailers of lawnmowers doing business in international markets need to be aware of the changes in regulatory compliance requirements for lawnmowers and turf care equipment. EN ISO 5395-based standards replaces the EN 836-based standards on September 30, 2014, and are categorized under the C-type standards.
The three parts of EN 5395 standards are as follows:
- EN ISO 5395-1:2013 Garden equipment - Safety requirements for combustion-engine-powered lawnmowers - Part 1: Terminology and common tests (supersedes EN 836:1997+A4:2011)
- EN ISO 5395-2:2013 Garden equipment - Safety requirements for combustion-engine-powered lawnmowers - Part 2: Pedestrian-controlled lawnmowers (supersedes EN 836:1997+A4:2011)
- EN ISO 5395-3:2013 Garden equipment - Safety requirements for combustion-engine-powered lawnmowers - Part 3: Ride-on lawnmowers with seated operator (supersedes EN 836:1997+A4:2011)
EN 836 specified the requirements and verification means for pedestrian-controlled, ride-on and lawn/garden tractors with mowing attachments, including professional machines. It excluded lawn trimmers, scrub cutters and rotary mowers with non-metallic cutters with KE not greater than 10 Joules. According to the European Standards Commission, the EN 836 standard ceases to give a presumption of conformity on September 30 2014 and the EN ISO 5395-based standards (EN ISO 5395-1:2013; EN ISO 5395-2:2013, EN ISO 5395-3:2013) will be given the status of a national standard.
The revised EN ISO 5395:2013 -1 safety standard series provides design requirements and test procedures required to achieve a valid presumption of conformity with the Essential Requirements of Directive 2006/42/EC and associated EFTA regulations.
Some of the major changes driven by the EN ISO 5395-:2013 standards include:
- Updates Technical Construction Files and Declaration of Conformity documents
- No mow in reverse
- Impact Test
- Parking and service brake actuation
- Test Equipment Requirements
- Cutting means transport
- Electromagnetic Immunity
- Operator Presence Control
- Artificial Weathering Test
For more information on the changes to these items, be sure to download our whitepaper: Are Your Mowers Up To Speed with EN 5395:2013 Requirements?
Product safety and regulatory compliance is a critical issue for manufacturers of home and garden products. Domestic and international distribution channels as well as end-users demand safety, reliability and rigorous compliance to existing and emerging standards. In addition to the EN 5395-based standards, TÜV Rheinland also provides certification in accordance with B71.4 and B71.1 standards.
B71.1 specifies the safety specifications of Consumer Turf Care Equipment – Pedestrian-Controlled Mowers and Ride-On Mowers. This standard applies to reel and rotary walk-behind power lawn mowers, reel and rotary ride-on power lawn mowers, ride-on power lawn tractors with mower attachments, ride-on power lawn and garden tractors with mower attachments, and lever steer ride-on mowers intended to apply to consumer products for personal use.
Safety specifications outlined in B71.4, US Commercial mower standard, apply to powered pedestrian-controlled, towed, and ride-on machines intended for marketing as commercial turf care equipment and that are customarily used by hired operators, and to all aftermarket parts, attachments and accessories provided by the original equipment manufacturer and others.
Call us today to see if your mowers comply with the changes driven by the new EN ISO 5395.
If you are attending the GIE+EXPO show October 23-24, 2014 in Kentucky, consider meeting with a TÜV Rheinland expert during the show. We can help you understand what you need to do be in compliance!
To what degree does regulation help/hinder innovation?
More than 250 attendees representing many facets of the healthcare industry will be attending the two day Connected Health Conference. These cutting edge workshops will include:
- Overcoming Barriers to Deployment of Health at Scale
- Building the Economic Bridge Through Connected Health Ecosystems
- Biosimilars, Cloud Computing Research and Risk Stratification
- Patient Portable Data
- Connected Health Simulations Rather Than Trials
- And more...
Chad Schieken, Regional Practice Leader, Security, OpenSky and Geoffrey Bock, Senior Business Development, Environmental Services, TUV Rheinland will be participating on a panel on the topic of Medical Device Suite of Standards – to what degree does regulation help/hinder innovation? This panel will be held at 2:45pm on Wednesday, October 22, 2014.
EU-US eHealth Marketplace and Conference
Massachusetts State House
Tues. October 21—Wed. October 22
||Geoffrey Bock is the Senior Business Development Manager for Green and Environmental Services at TUV Rheinland. He is currently involved in developing business for Green Services including RoHS, REACH, WEEE, Certification, and 3rd Party partnerships to provide a full range of Environmental Services to our clients. He recently joined the NSF 426 Environmental Leadership Standard for Servers and is the Task Group Leader for “Substances of Concern.” He often provides training and seminars for clients nationally and globally.
||Chad Schieken is a Regional Practice Leader/Security at OpenSky. is an innovative executive and experienced compliance professional managing and delivering services focused on information security, privacy, and internal control. Chad has deep knowledge of various legal, regulatory, and industry requirements and is highly effective in business development settings. He has over 20 years of professional experience in information security in a variety of settings. His primary areas of expertise include risk assessment and analysis, privacy, compliance, vulnerability management, merger and acquisition risk management, security policy, and security awareness training. Chad has in-depth experience with various audit standards, compliance requirements (PCI DSS, HIPAA, GLBA, and FISMA) and practical knowledge of various technologies.
Click here to register for the conference.
The average wait time for Testing of Gas Detectors in the U.S. can take from anywhere from 4 to 6 months. This means a significant delay in time to market and even delayed revenue for North American manufacturers.
In an effort to help North American gas detector manufacturers dramatically reduce their time to market, TUV Rheinland of North America will now offer IEC 60079-29-1 certification services.
The IEC 60079-29-1 standard specifies the general requirements for construction, testing and performance, and describes the test methods that apply to portable, transportable and fixed apparatus for the detection and measurement of flammable gas or vapor concentrations with air.
In collaboration with our labs in Cologne, we can now start your test within a two-to-four-week period. Our expanded facility in Cologne is equipped with state of the art equipment. Our experts are knowledgeable with all the regulations and directives you need including IEC/EN 60079-29-1, to get your products to market.
Click here to read the press release on this new service.
TÜV Rheinland provides IECEx Certification, ATEX and HazLoc Testing, EMC Testing, Functional Safety and Machinery Safety.
Contact us today for lab availability, or other ways we can help you meet your testing needs!
Contact TÜV Rheinland
(888) 743-4652 |email@example.com
Image Courtesy: Image used with permission from Honeywell
Revised OSHA Rule Requires Employers to Report All Serious Injuries within 24 Hours and Fatalities within 8 Hours
Occupational Safety and Health Administration (OSHA) released a new rule on September 11, 2014 which updates the Occupational Injury and Illness Recording and Reporting Requirements, as well as list of employers partially exempt from OSHA recordkeeping requirements. The newly updated rules will go into effect on Jan. 1, 2015, for workplaces under federal OSHA jurisdiction.
Employers must notify the agency when an employee is killed on the job or suffers a work-related hospitalization, amputation or loss of an eye. Under the revised rule, employers will be required to notify OSHA of work-related fatalities within eight hours, and work-related in-patient hospitalizations, amputations or loss of an eye within 24 hours. Under the prior rules, an employer was required to notify OSHA, if a worker is killed on the job, or if three or more workers were hospitalized. Reporting single hospitalizations, amputations or loss of an eye was not previously required.
State plan states will set the implementation dates for their employers, but OSHA Administrator David Michaels encouraged those states to implement the new provisions on Jan. 1 2015. Please click here to review the OSHA fact sheet.
Federal Annual Monitoring and Evaluation (FAME) OSHA Reports
In accordance with the Occupational Safety and Health Act of 1970 (the Act), OSHA conducts an evaluation of the 27 approved State Plans each fiscal year. Section 18 of the Act encourages States to develop and operate their own job safety and health programs and OSHA approves and monitors them.
There are currently 22 States and jurisdictions operating complete State plans while 5 states cover public employees only. Federal OSHA has recently released its FY 2013 Comprehensive Federal Annual Monitoring Evaluation (FAME) Reports.
Employers in these 27 State OSHA programs are forewarned as Federal OSHA continues to pressure the State plans to increase their enforcement activities, issue more citations, and increase penalties. State OSHA programs must be “at least as effective” as Federal OSHA, or Federal OSHA may take over. According to federal OSHA’s Reports, the current penalties proposed by state workplace safety and health regulators continue to lag behind penalties proposed by the federal OSHA. Independent analysis shows that only a handful of states cited violations at par with OSHA.
Some of the other findings include:
- California is understaffed and experiences a long period between an inspection and issuance of a citation. California has nine findings and recommendations remaining from the last year’s (FY 2012) FAME report, including a recommendation to improve targeted programmed inspections in light of a “significantly lower” percentage of inspections with serious, willful or repeat violations being issued.
- Hawaii, which is sharing jurisdiction with federal OSHA while working to improve its program, has made progress but still experiences program management and enforcement issues.
- In a turnabout after receiving sharp criticism several years ago for a number of construction fatalities, Nevada’s program is considered “effective,” albeit with a need to improve staff retention and supervisory oversight. The employee turnover rate in Nevada – 53 percent – is the highest among the programs and is seen as an “ongoing challenge.”
- Washington is the first state in the nation to adopt a rule designed to protect health care workers from exposure to chemotherapy drugs and other hazardous drugs.
Do you know how your states performed? Click here to download your States FAME report.
TÜV Rheinland of North America can help identify and work with your team to eliminate and minimize risks. We provide EHS consulting and compliance assistance, Industrial hygiene (IH) services, OSHA consulting, field labeling, training and more. Click here to learn about our EHS Services!
Contact TÜV Rheinland
(888) 743-4652 | firstname.lastname@example.org
Manufacturers and importers of scientific, test and measurement equipment sold in the European Union will need to upgrade to the new requirements of EN 61326‐1:2013, the standard guiding EMC emissions and immunity requirements. The latest version is a technical update to the 2006 edition and must be complied with by August 14, 2015.
Along with the updated basic standards references, the 2013 version has the following new requirements:
- Technical changes were made for the equipment under the “basic environment” requirements in table 1.
- The air discharge ESD test level has been increased from 4KV to 8KV.
- A requirement for immunity to magnetic fields according to IEC 61000‐4‐8 has been added but only for susceptible devices.
- Additional details were added to the performance criteria for the immunity testing.
- New section 9 adds requirements for the user manual.
Even though the compliance deadline is about a year from now, manufacturers can make a smooth and stress-free transition by getting ready in advance. TÜV Rheinland can review your declaration of conformity and EMC reports and provide the testing services and guidance required to comply with this update. For further information, contact Bruce Fagley, EMC Technical Manager, TÜV Rheinland, at email@example.com or at (203) 558‐2703.
Effrective July I, 2014, Construction Products regulation mandates the CE marking of fabricated steel and aluminum structures in accordance with the EN 1090 standard, titled Execution of Steel Structures and Aluminum Structures Parts 1 and 2.
||The regulation makes CE marking of structures mandatory in accordance with Harmonized Standards for the following:
A failure to meet the new Construction Products Regulation requirements will disqualify a product from carrying a CE mark, and penalties may include suspension and prohibition notices and fines.
- Components for construction market (steel, aluminum, beams, bolts and similar)
- Fabricated elements and systems made from CE marked products.
US exporters of construction products including steel sections, structural bolts, welding consumables, and fabricated steel components used in buildings, bridges, highways, and other civil engineering structures, will have to comply with the Construction Products Regulation if their product is to be accepted on the European market.
TÜV Rheinland can now help construction professionals with CE marking of products and also achieve the mandatory EN 1090 certification, a pre-requisite for the CE mark.
Click here to read our detailed press release and learn about the three-mandatory steps to demonstrate compliance.
Contact Mark Forbes or Steve Norris if you want more information.
Attend our complimentary seminar on PV components, connectors, & energy storage solutions!
TUV Rheinland tests relate to individual components of the system as a whole, but are aimed at the safe and reliable interaction of all components in the overall system.
What you will learn from attending the seminar:
- Which standards are needed for testing and certification of PV components?
- Which technical standards are under current development and what is their current status?
- What is the technical content of the standards (brief explanation only)?
- Practical tips how to avoid failure and how to recognize those in the PV Field (interoperability of PV connector)
- Which standards have to be applied in order to design safe Energy Storage Systems?
Details: (prior to SPI in Las Vegas)
When: Sunday, Oct. 19, 2014
Where: Las Vegas Marriott, 325 Convention Center Drive, Las Vegas, Nevada
Includes refreshments and beverages
Inverter manufacturers must test products effectively to meet safety, grid connection, and certification requirements. It's important that inverter manufacturers have an understanding of the safety and grid connection requirements from the beginning. If an inverter is designed without compliance in mind, then changes to the design may be required late in the development process.
The utility grid is a complex interconnection of generating sources and loads. In this webinar a brief overview of the utility grid will be presented, along with some of the requirements of how distributed generating systems must connect to it.
- The Utility Grid
- Power Flow
- Voltage Regulation
- Overcurrent Protection
- Point of Common Coupling
- Requirements of the inverter connecting to the grid
Wednesday, September 10th
2:00pm ET or 11:00am PT
Presenter: Paul Morton
|Mr. Morton is an Engineer in the Solar and Fuel Cell Division of TUV Rheinland and is a Professional Engineer in the Province of Ontario, with over 25 years of experience in product safety and evaluation. He is an active member on CSA Committees on standards related to inverters. He has extensive experience in the testing and evaluation of switch mode power supplies and inverters.