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RoHS or EU 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.

In 2011, the EU published the RoHS 2 Directive 2011/65/EU, and it includes the CE marking directive with RoHS compliance now being required for CE marking of products.

The original RoHS and the RoHS 2 covers 6 substances. Maximum concentration values tolerated by weight in homogeneous materials (every material in the device) are below:

Four heavy metals and their compounds:

  1. Lead (Pb): < 1000 ppm (=0.1%)
  2. Mercury (Hg): < 1000 ppm
  3. Cadmium (Cd): < 100 ppm (=0.01%)
  4. Hexavalent Chromium (Cr VI): < 1000 ppm

And two brominated families:

  1. Polybrominated Biphenyls (PBB): < 1000 ppm
  2. Polybrominated Diphenyl Ethers (PBDE): < 1000 ppm

On July 22, 2019, the EU published Directive 2015/863, known as RoHS 3 which adds four additional restricted substances (phthalates) to the list of six.

  1. Bis(2-Ethylhexyl) phthalate (DEHP): < 1000 ppm
  2. Benzyl butyl phthalate (BBP): < 1000 ppm
  3. Dibutyl phthalate (DBP): < 1000 ppm
  4. Diisobutyl phthalate (DIBP): < 1000 ppm

Phthalates are a family of chemicals used in various consumer products and industries have been using phthalates about 50-60 years ago. Phthalates make the plastics soft specifically vinyl plastic which is made from PVC. They sometimes known as everyday chemicals.

RoHS covers following 11 categories of EEE published in Directive 2011/65/EU Annex 1:

  1. Large household appliances.
  2. Small household appliances.
  3. IT and telecommunications equipment.
  4. Consumer equipment.
  5. Lighting equipment.
  6. Electrical and electronic tools.
  7. Toys, leisure, and sports equipment.
  8. Medical devices.
  9. Monitoring and control instruments including industrial monitoring and control instruments.
  10. Automatic dispensers.
  11. Other EEE not covered by any of the categories above.

Below is a list of exempted product categories from RoHS found in Article 2 of Directive 2011/65/EU:

  1. Equipment intended for military purposes.
  2. Equipment designated to be sent into space.
  3. Large-scale stationary industrial tools such CNC machine, cranes, etc.
  4. Large-scale fixed installations such as electrical distribution
  5. Fixed photovoltaic panels that produce energy from solar light for public, commercial, industrial, and residential applications.
  6. Non-road mobile machinery such as railway, waterway, construction machines.
  7. Transportation vehicles, excluding electric two-wheeled vehicles.
  8. Active implantable medical devices like pacemakers, defibrillators.
  9. Equipment designed solely for the purposes of research and development.

You can find a RoHS list of exemptions in Annex III of Directive 2011/65/EU. Manufacturers, distributors, and importers all need to comply with current RoHS exemption list.

RoHS Testing

There are two options: either you do the test yourself, or you benefit from tests that stakeholder in your supply chain has already conducted. Then you use the gathered information to make your technical file. In essence, you would either perform RoHS analytical tests or prepare a documentary assessment.

  1. Analytical Approach:

X-ray fluorescence spectroscopy (XRF) has been established as a quick screening method as the fastest and most convenient method. (XRF)/RoHS Analyzer can be used to accurately to test the corresponding standard samples of the five elements of lead (Pb), mercury (Hg), cadmium (Cd), chromium (Cr), and bromine (Br).

Chromatography for RoHS Testing

Chromatography consists of chemically separating the elements of a dissolved mixture.

As result, chromatography allows us to identify and quantify these elements.

Gas chromatography enables to detection of the presence of PBB, PBDEs, or phthalates and

find out their concentration in each material.

The standard for analytical testing is IEC 62321 (Determination of certain substances in electrotechnical products) and gives out guidelines for testing.

RoHS applies at the homogeneous material level, so every component will have to be accessed for compliance. For example, in the case of a semiconductor, which contains multiple homogeneous materials such as plastic, molding material, tin electroplating coatings on the lead frame, the lead frame alloy, and gold-bonding wires, each of these materials would be subject to the Maximum Concentration Values (MCVs) as per RoHS regulations.

According to RoHS directives, a homogeneous material is defined as:

“A material that cannot be mechanically disjointed into different materials.”

In simpler terms, if you were to break down a product into its smallest parts, a homogeneous material would be one where each part has the same composition throughout and cannot be separated into different substances by mechanical means. This means that each component of the material must meet the requirements of RoHS independently.

This makes it very time consuming and costly when you are testing any electronic device that typically has hundreds of different homogeneous materials. In addition, it requires specialized equipment and trained personnel for testing. Hence this approach, may not be feasible for large-scale or continuous monitoring of compliance.

  1. Documentary Approach:

The documentary approach to RoHS compliance involves conducting a risk analysis based on the product bill of materials and utilizing information provided by suppliers to confirm compliance with RoHS regulations. This method is particularly useful when comprehensive analytical testing of every component is not feasible.

Here’s how you can implement the documentary approach:

  • Gather Bill of Materials (BOM): Collect detailed information about the materials and components used in your product. This includes information on suppliers, part numbers, specifications, and any available compliance documentation.
  • Supplier Information: Request compliance documentation from your suppliers, such as Certificates of Compliance (COCs) and harmonized Safety Data Sheets (SDSs). These documents should provide information on the RoHS status of the materials and any hazardous substances present.
  • Risk Analysis: Conduct a risk analysis based on the information gathered from the BOM and supplier documentation. Identify materials and components that are likely to contain restricted substances and prioritize them for further scrutiny.
  • Compliance Confirmation: Use the technical documentation and risk analysis to confirm compliance with RoHS requirements. This may involve conducting selective testing or verification of critical components if necessary.
  • Periodic Review: Regularly review and update your technical documentation to ensure ongoing compliance with RoHS regulations. Stay informed about any changes or updates to regulatory requirements and adjust your processes accordingly.

All of these is achieved by technical documentation: To help you build sufficient technical documentation, on 15 May 2020, the European Commission published the Commission Implementing Decision (EU) 2020/6591 to adopt EN IEC 63000:2018 as the new harmonized standard for assessing the technical documentation to support the compliance assessment of RoHS Directive 2011/65/EU. The previous standard EN 50581:2012 will be withdrawn by 18 November 2021.

Here is what the IEC 63000 Standard states in its introduction:

“For those restrictions that apply at the ‘homogeneous material’ level, it is impractical for manufacturers of complex products to undertake their (…) testing of all materials contained in the final assembled product.

 Instead, manufacturers work with their suppliers to manage compliance and compile technical documentation as evidence of compliance”.

Therefore, IEC 63000 promotes the technical documentation with a documentary review for complex products. Both industry and most enforcement authorities recognize this approach.

Along with IEC, CENELEC, as the European Committee for Electrotechnical Standardization, also supports and recommends the documentary approach for RoHS compliance. Recognizing the complexity of modern products and the challenges associated with comprehensive analytical testing, CENELEC advocates for a risk-based approach that emphasizes the importance of thorough documentation and supplier cooperation.

To update your technical file, you will only need to gather the missing information for the additional parts and according to the latest applicable regulatory changes.

Content of the Technical Documentation per IEC 63000 includes:

  1. Product compliance declaration
  2. Bill of Materials (BOM)
  3. Material Data Sheets
  4. Test Report
  5. Supplier Declarations
  6. Compliance Documentation
  7. Traceability Records
  8. Product Labeling Information
  9. Periodic Review and Updates

Clear 4C, recommends the documentary approach as it is generally, more cost-effective than analytical testing and it can be implemented quickly and efficiently. It also relies on supplier transparency and cooperation.

Contact us today or book a free consultation call through our calendar for all your RoHS compliance needs and we will strive to accommodate you to the best of our abilities.

Email: rahul.amin@clear4c.com

Phone: 203-715-7372