Intertek solutions for compliance with EU RoHS 2 Directive (2011/65/EU and 2015/863) requirements.

The EU RoHS Directive (2011/65/EU amended by 2015/863), also known as RoHS 2,  has CE marking and declaration of conformity requirements.  Before placing electrical and electronic equipment (EEE) on the market, a manufacturer / importer / distributor must ensure that the appropriate conformity assessment procedure has been carried out and is in line with IEC63000.  They must also ensure they have affixed the CE marking on the finished product.  

The RoHS Directive restricts the use of Lead (Pb), Mercury (Hg), Cadmium (Cd), Hexavalent chromium (Cr6+), Polybrominated biphenyls (PBB), and Polybrominated diphenyl ether (PBDE) in manufacturing of electrical and electronic equipment sold in the European Union. As of July 2019, the Directive restricts 4 phthalates – DBP, DEHP, DIBP & BBP in a number of product categories.  The inclusion of the phthalates for the remaining product categories will come into force July 22, 2021.  

The RoHS Directive scope extends to all electrical and electronic equipment (EEE), including medical devices, monitoring and control instruments and other commercial products.

In order for your CE Technical file to comply with IEC 63000 it should address the following areas: 

  • Restricted Substance Control Program – A Quality Management System type process that addresses design for compliance, supplier qualification as well as Manufacturing processes and how these helps mitigate risk of non-compliance.
  • Due Diligence – Compliance information gathered and generated by your suppliers that address your components' and materials' compliance status.  This information can be Certificates of Compliance (CoC), Test Reports, or Material Declarations. 
  • Conformity Assessment – Documentation justifying that all components and materials are considered low-risk of non-compliance through typical composition, the due diligence gathered or through risk mitigation strategies (such as testing or auditing a contract manufacture)

There are 11 Categories that EEE can fall within scope of the EU RoHS Directive:

 Large-Household-Appliance 1. Large Household Appliances
(Washing Machines, Ovens,
Refrigerators, AC)
     Toys-Leisure-and-Sports-Equipment 7. Toys, Leisure and Sports Equipment
(Video Games, Console, Treadmill, 
Slot Machine) 
 Small-Household-Appliances 2. Small Household Appliances
(Vacuum Cleaners, Toasters,
Coffee Machine)
    Medical-Devices 8. Medical Devices
(Cardiology, IVD, Dialysis,
Blood Analyzers)
 IT-and-Telecommunications 3. IT and Telecommunications
(Computers, Servers, Cell Phones,
   Monitoring-and-Control-Instruments 9. Monitoring & Controlling Instruments
(Flow Meters, Thermostats,
Smoke Detector, Alarms)
 Consumer-Equipment 4. Consumer Equipment
(TV, Guitar, Video Camera)
    Automatic-Dispensers 10. Automatic Dispensers
(ATM, Beverage Dispensers)
 Lighting-Equipment 5. Lighting Equipment
(Lamps, Portable Stadium Lighting, 
11. Other EEE Not Covered By Other

(Cables, Other Grey Area Products)
 Electrical-and-Electronic-Tools 6. Electrical and Electronic Tools
(Drills, Sewing Machine, Saws,
     * Includes Industrial Monitoring & Control

EU RoHS 2 Recast Directive (2011/65/EU, 2015/863) Services

Intertek provides a single-source solution for RoHS compliance, supported by RoHS experts, enabling Intertek to help companies successfully facilitate their RoHS compliance.  Intertek services can be provided as a turn-key solution or individually to support specific key steps in the compliance process:

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