RoHS Certification

Overview of RoHS Compliance Certification

RoHS stands for Restriction of Hazardous Substances. It restricts the usage of certain harmful substances used in electrical and electronic equipment. In India, there is a great demand for electronic products that use hazardous substances which harm the environment and human health.

RoHS Directives were formed to spread awareness among consumers and restrict the use of harmful substances in electrical and electronic equipment. Keeping all the dangerous effects of electronic waste in mind, The Ministry of Environment and Forest, and the Government of India are encouraging the Restriction of Hazardous Substances (RoHS) under E-waste Management.

Role of Agile Regulatory - RoHS Certification

Agile Regulatory can guide and assist in many ways:

• We arrange product testing with the help of accredited labs to check the restricted substances
• We evaluate the product’s current compliance with RoHS standards.
• We help to Identify restricted substances.
• We ensure the test reports align with RoHS directives
• We review all documentation and supplier declarations.
• We help in complying with the Technical Construction File which is required for RoHS compliance.
• We verify supplier declarations and material certificates
• Guide the customers in replacing hazardous components with compliant alternatives.
• Assist in drafting the EU Declaration of Conformity (DoC).
• Ensures CE marking requirements
• We regularly monitor updates and changes in RoHS legislation.

Agile Regulatory works by simplifying the RoHS certification process by reducing complexity and ensuring documentation accuracy with compliance approvals.

Importance of ROHS Certification

RoHS Compliance is important for manufacturers, importers, or exporters dealing in electrical and electronic equipment as:

• It is a legal requirement for any EEE Product to be sold in many countries like the European Union and the United Kingdom.
• In India, RoHS Compliance has been encouraged under E-Waste Management to use less harmful substances. In the future, it might be a legal requirement in India as well. Therefore, companies already in compliance with RoHS will have a competitive edge.
• Indian Consumers are becoming more aware of the environment and health safety. Therefore, a RoHS-compliant product influences their buying decision.

Who needs to Obtain ROHS Compliance?

• Companies that manufacture or import electrical and electronic components for Retail or Industrial use. (Some exemptions are mentioned below in the article).
• RoHS compliance is mandatory in countries like the EU, UK, etc. Businesses having any presence in these countries must comply with the RoHS Directive.

History and Background of RoHS

• The first RoHS directive (2002/95/EC) was adopted by the European Union on January 27, 2003, and took effect on July 1, 2006.
• In 2011, RoHS 2 replaced RoHS 1, adding CE marking, more product categories, and stricter measures.
• The RoHS 3, Directive 2015/863 was an amendment to RoHS 2 that added four additional restricted substances by making it a total of ten restricted substances.
• Later it was adopted by many other countries like China, India, Japan, South Korea, and the UAE.

Industries Affected by ROHS Compliance Requirements

Many industries are impacted by ROHS Compliance, such as:

• Automotive Industry: They include electronic vehicle components like infotainment systems, sensors, and battery management systems.
• Electronics & Electrical: It covers various consumer electronics, industrial equipment, medical devices, and more.
• Medical Device Industry: Various Medical Devices like imaging equipment, diagnostic tools, and electronic medical instruments.
• Aerospace & Defense : Multiple Military and aerospace applications are affected, though some exemptions exist.
• Lighting equipment: like LED, fluorescent, and electronic lighting products
• Telecom Industry: ​​​​​​​​​​​​​​It includes Networking equipment, mobile devices, and communication systems.

List of ROHS Restricted Substances and their allowable limits

Many harmful substances are restricted and their allowable limits as defined under RoHS guidelines are as follows:

• Mercury – 0.1% (1000 ppm)
• Lead – 0.1% (1000 ppm)
• Hexavalent Chromium – 0.1% (1000 ppm)
• Polybrominated Biphenyls – 0.1% (1000 ppm)
• Cadmium – 0.01% (1000 ppm)
• Polybrominated Diphenyl Ethers– 0.1% (1000 ppm)
• BisPhthalate  – 0.1% (1000 ppm)
• Benzyl Butyl Phthalate – 0.1% (1000 ppm)
• Dibutyl Phthalate – 0.1% (1000 ppm)
• Diisobutyl Phthalate – 0.1% (1000 ppm)

List of exempted products under RoHS

• Military equipment
• Aerospace equipment
• Most automotive equipment
• Products still under research & development
• A few medical devices
• Photovoltaic panels
• Large-scale stationary industrial tools and large-scale fixed installations

Documents required for RoHS Compliance

To obtain RoHS Compliance, the following documents are required:

• Declaration of Conformity
• Bill of Materials having all the components, and materials.
• Product name, model, and specifications.
• RoHS Lab test reports
• Supplier declarations of RoHS compliance
• Certificate of Compliance from Component Manufacturer
• Design and technical drawings
• Material composition reports
• Quality control and production process documents
• RoHS Compliance Declaration

Steps by Step Process for ROHS Compliance Certificate

Following are the steps that should be followed to obtain RoHS Compliance:

• Step 1: Identify if the product falls under the RoHS directive and applicable exemptions.
• Step 2: Create a Bill of Material (BOM) declaring all the components and materials used in your product.
• Step 3: Request a supplier declaration for each listed item in your Bill of Material stating whether the components used comply with the RoHS Directive.
• Step 4: If unable to obtain the supplier declarations, the Company can also use laboratory testing from an NBL-accredited laboratory to verify their compliance with the Directive. (Details of the Lab Testing Process are mentioned below).
• Step 5: Prepare a technical File (TF) that covers:

                • Bill of Material (BOM)

                • Supplier Declaration

                • Product Description

                • Risk Assessments

                • Test Reports from Accredited Labs

                • Manufacturing Process Details

• Step 6: After Compiling all the documents, the company can demonstrate RoHS Compliance through self-declaration. Self-declaration is done by creating a Declaration of Conformity (DoC).

What is the Lab Testing Process for RoHS?

One has to follow the below steps for the Lab testing Process for ROHS:

Step 1: Collect all the representative samples of the product and its components. Separate the product into different materials like plastic, metal, and solder. Ensure the sample is uniform for accurate testing.

Step 2: Identification of RoHS-Regulated Substances should be done along with the restrictions on 10 hazardous substances:

• Lead (Pb) – 0.1% (1000 ppm)
• Mercury (Hg) – 0.1% (1000 ppm)
• Cadmium (Cd) – 0.01% (100 ppm)
• Hexavalent Chromium (Cr⁶⁺) – 0.1% (1000 ppm)
• Polybrominated Biphenyls (PBB) – 0.1% (1000 ppm)
• Polybrominated Diphenyl Ethers (PBDE) – 0.1% (1000 ppm)
• Bis(2-Ethylhexyl) Phthalate (DEHP) – 0.1% (1000 ppm)
• Butyl Benzyl Phthalate (BBP) – 0.1% (1000 ppm)
• Dibutyl Phthalate (DBP) – 0.1% (1000 ppm)
• Diisobutyl Phthalate (DIBP) – 0.1% (1000 ppm)

Step 3: There are mainly two methods for RoHS testing:

Screening Tests: It is a fast and cost-effective method but has limited accuracy for phthalates and Cr⁶⁺.

• X-Ray Fluorescence: Rapid, non-destructive method to detect elemental composition like lead, cadmium.

Analytical Chemical Tests: It is highly accurate and compliant with RoHS standard, but very time consuming and expensive.

• ICP-OES (Inductively Coupled Plasma Optical Emission Spectroscopy): It measures heavy metals like Pb, Cd, and Hg.
• GC-MS refers to Gas Chromatography-Mass Spectrometry: It identifies and quantifies organic compounds like PBB, PBDE, and phthalates.
• UV-Vis Spectroscopy: It analyzes hexavalent chromium with a colorimetric reaction.

Step 4: Compare measured concentrations with RoHS limits by Preparing a Compliance Report by various:

• Test methods and equipment used.
• Substance concentrations.
• Pass or Fail status for each material

Step 5: The documentation step is important during the lab testing process. If the reports complies with the RoHS Directive:

• It can serve as evidence to support the Declaration of Conformity.
• The Declaration of Conformity with all the technical documents will be valid to show RoHS Compliance for as long as the product stays RoHS Complaint.

If the product fails:

• Identify all the non-compliant components.
• The product should be modified and re-tested.

Step 6: Under Ongoing Compliance process:

• Periodic testing should be conducted for product updates.
• Maintain a RoHS compliance management system.

Cost to Obtain RoHS Compliance Certificate

Agile Regulatory can assist with RoHS compliance documents (including DOC with all other technical documents) in under INR 5,000 (excluding lab test price which is not always required).