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!