Is Your Organization RoHS 3 Compliant for 2020?
RoHS stands for Restriction of Hazardous Substances, and impacts the entire electronics industry and many electrical products as well. The original RoHS, also known as Directive 2002/95/EC, originated in the European Union in 2002 and restricts the use of six hazardous materials found in electrical and electronic products. All applicable products in the EU market since July 1, 2006 must pass RoHS compliance.
Directive 2011/65/EU was published in 2011 by the EU, which is known as RoHS-Recast or RoHS 2. RoHS 2 includes a CE-marking directive, with RoHS compliance now being required for CE marking of products. RoHS 2 also added Categories 8 and 9, and has additional compliance recordkeeping requirements.
Directive 2015/863 is known as RoHS 3. RoHS 3 adds four additional restricted substances (phthalates) to the list of six. The RoHS 3 Deadline was 22 July 2019.
Any business that sells applicable electrical or electronic products, equipment, sub-assemblies, cables, components, or spare parts directly to RoHS-directed countries, or sells to resellers, distributors or integrators that in turn sell products to these countries, is impacted if they utilize any of the restricted 10 substances.
With the rapid spread of digitization, the world's production of electrical and electronic devices is exploding. Besides mobile devices, think about the coming wave of IoT, smart home assistants, robots, drones, 3D printers, and home medical devices to all corners of the planet....they are all regulated under RoHS.
EU RoHS specifies maximum levels for the following 10 restricted substances. The first six applied to the original RoHS while the last four were added under RoHS 3, which took effect July 22, 2019.
- Cadmium (Cd): < 100 ppm
- Lead (Pb): < 1000 ppm
- Mercury (Hg): < 1000 ppm
- Hexavalent Chromium: (Cr VI) < 1000 ppm
- Polybrominated Biphenyls (PBB): < 1000 ppm
- Polybrominated Diphenyl Ethers (PBDE): < 1000 ppm
- Bis(2-Ethylhexyl) phthalate (DEHP): < 1000 ppm
- Benzyl butyl phthalate (BBP): < 1000 ppm
- Dibutyl phthalate (DBP): < 1000 ppm
- Diisobutyl phthalate (DIBP): < 1000 ppm
RoHS-Impacted Product Categories
The RoHS Directive applies to products in Categories 1 thru 11 (as per Schedule 1 of the WEEE Directive). RoHS also applies to all wire, cables, and associated connectors, both internal and external.
The following product categories are impacted under the RoHS Directive:
Category 1: Large household appliances - refrigerators, washers, stoves, air conditioners
Category 2: Small household appliances - vacuum cleaners, hair dryers, coffee makers, irons
Category 3: Computing & communications equipment - computers, printers, copiers, phones, satellite TV, cell tower equipment, antennas
Category 4: Consumer electronics - TVs, DVD players, stereos, video cameras
Category 5: Lighting - lamps, lighting fixtures, light bulbs (some fluorescents are exempt)
Category 6: Power tools - drills, saws, nail guns, sprayers, lathes, trimmers, blowers
Category 7: Toys, leisure and sports equipment - videogames, treadmills, talking dolls, Fitbits
Category 8*: Medical devices and equipment - includes in-vitro diagnostic medical devices (IVDs)
Category 9*: Monitoring and control equipment - thermostats, smoke detectors, fire alarms, including industrial applications
Category 10: Automatic dispensers - vending machines, ATM machines
Category 11**: Catch-all - all other electronic and electrical equipment not covered under the other categories. Included are 2-wheeled electric vehicles; electronic nicotine delivery systems (ENDS) such as e-cigarettes, cannabis vaporizers and vape pens; electrical cables that are less than 250V working voltage.
* Compliance deadline for Category 8,9 products for RoHS 3 phthalate restriction is July 22, 2021
** Compliance deadline for Category 11 products is July 22, 2019
RoHS-Exempted Product Categories
The following product categories are currently exempted from RoHS compliance. Of note is that these exemptions are largely application or industry dependent:
Military - equipment used for defense or national security
Space - equipment sent into space such as satellites, telescopes, spacecraft
Transportation - vehicles used for transport (except 2-wheeled electric vehicles)
R&D - equipment used for professional research and development
Non-road mobile machinery (NRMM) - agricultural, railway, waterway, construction machinery
Large-scale fixed installations (LSFI) - electrical distribution, HVAC, robotic equipment and lines
Large-scale stationary industrial tools (LSSIT) - CNC, milling, metal-forming, testing machines; cranes
Fixed-location photovoltaic panel (PV) installations
Active Implantable Medical Devices (AIMDs) - pacemakers, implanted defibrillators, insulin pumps
Sub-equipment for out-of-scope equipment
Batteries - just the cells, not external wiring
Compact flourescent light bulbs/lamps
Spare parts for equipment in the market before RoHS took effect - applies to all except for Category 11 products
Steps to Certification
The following steps are involved for RoHS certification.
1. Testing: Either on-site or XRF testing and/or lab phthalate solvent extraction testing is done to determine values of the ten restricted RoHS substances.
2. Process Audit: Inspect all applicable manufacturing processes used towards RoHS compliance on-site.
3. Documentation Review: Review the Bill of Materials, Technical File, assembly drawings, materials declarations, test reports, and conformance/compliance certificates from all suppliers.
The Technical File must contain the following:
General product description and design structure information
Risk assessment of materials, parts and subassemblies
Conformity information on materials, parts, and subassemblies
Manufacturing documentation and records
Harmonized standards, specifications, and conformity procedures
4. Certification Statement: After a successful audit, a RoHS Certificate of Compliance (also known as a Certificate of Conformity or Declaration of Conformity) is issued.