Environmental sustainability and product safety are now fundamental elements for companies operating in the electrical and electronic equipment sector. In this context, the RoHS Directive (Restriction of Hazardous Substances) is a key regulation to ensure product safety and environmental protection.
What is the RoHS Directive and its objective?
The RoHS Directive 2011/65/EU, updated by Directive 2015/863/EU (RoHS III), imposes restrictions on the use of certain hazardous substances in electrical and electronic products. This directive is closely linked to the WEEE Directive (2012/19/EU), which was created to address the issue of obsolete electronic waste, posing a threat to the environment, public health, and wildlife.
The primary goal is to reduce the environmental impact of electronic waste by limiting the use of toxic substances in products.
Which substances are regulated by RoHS?
The RoHS Directive limits the presence of specific hazardous substances in products intended for the European market, with defined concentration limits:
Lead (Pb): 0.1%
Mercury (Hg): 0.1%
Cadmium (Cd): 0.01%
Hexavalent Chromium (Cr VI): 0.1%
Polybrominated Biphenyls (PBB): 0.1%
Polybrominated Diphenyl Ethers (PBDE): 0.1%
Phthalates (DEHP, BBP, DBP, DIBP): 0.1% each
These substances are often present in solders, plastic coatings, and printed circuit boards, and their uncontrolled use can cause severe environmental and health damage.
Who must comply with the RoHS Directive?
Compliance with RoHS is mandatory to obtain the CE marking, a prerequisite for marketing electrical and electronic products in the European Union. Since January 2013, all CE-marked products must also meet RoHS requirements.
Product categories involved:
Large household appliances: refrigerators, washing machines, ovens
Small household appliances: vacuum cleaners, toasters
IT and telecommunications equipment: computers, smartphones, routers
Consumer devices: TVs, radios, camcorders
Lighting equipment: LED lamps, neon lights, bulbs
Electrical and electronic tools: drills, electric saws
Toys and electronic sports devices
Vending machines
Medical devices (with some exceptions)
Industrial monitoring and control instruments
Exemptions from the directive:
Military and aerospace equipment
Large-scale stationary industrial machinery
Certain types of photovoltaic panels
Transport vehicles, except for non-approved two-wheeled electric vehicles
Equipment for research and development purposes
In practice, if a product uses an electrical power source to function, even at low voltage, it falls under the electrical and/or electronic equipment covered by the RoHS Directive unless specifically exempted.
What does placing on the European market mean?
Understanding the concept of placing on the European market is crucial for ensuring RoHS compliance.
Products manufactured in the EU: Placement occurs when the product is transferred to a distributor or the final customer.
Products imported from non-EU countries: Placement occurs when the product clears customs in Europe, meaning when it is transferred to the importer’s or distributor’s warehouse or directly to the end user.
In both cases, the product must comply with RoHS requirements before being placed on the market. The body responsible for compliance verification may request the manufacturer to provide the technical file proving regulatory compliance. Failure to provide this documentation can result in product withdrawal from the market. Manufacturers and importers play a key role in ensuring compliance: they must request validation of components and semi-finished products from their suppliers to ensure the final product meets RoHS requirements throughout the production chain.
What tests are required for RoHS compliance?
To achieve RoHS certification, products must undergo specific laboratory tests to verify the presence of prohibited substances.
Types of Tests:
XRF Analysis (X-ray Fluorescence): A rapid method to detect heavy metals
In-depth Chemical Testing: Laboratory analysis to confirm the presence of banned substances
Mass Spectrometry (GC-MS): Advanced analysis to identify and quantify phthalates and organic substances
If declarations of conformity for used components are unavailable, it is necessary to rely on accredited laboratories for material testing.
Technical documentation and reference standards
The European Commission has introduced the harmonized standard EN IEC 63000:2018, providing guidelines on the technical documentation required to demonstrate RoHS compliance.
How to Demonstrate Compliance:
Supplier and material declarations
Contractual agreements with suppliers
Laboratory analytical test results
A combination of the above methods
Although no prescriptive method exists, IEC 63000, IEC 62321-2 Annex B, and IEC TR 62476 standards are recognized as reliable references for conducting a complete compliance assessment and proper risk analysis.
How to obtain RoHS certification?
Material assessment: thorough analysis of components and materials to identify prohibited substances
Laboratory testing: accredited testing of products to verify compliance with imposed limits
Technical documentation: creation of the technical file, which includes:
Declaration of Conformity (DoC)
Laboratory test reports
Risk analysis
Certification issuance: release of the RoHS Declaration of Conformity, necessary for CE marking
Validity of RoHS compliance
Compliance is valid until the product undergoes modifications or until a new directive comes into force. The manufacturer must keep the technical file updated and ensure compliance throughout the supply chain.
Importers introducing a product to the European market for the first time are also responsible for RoHS compliance.
How we can support you:
Analytical Group offers comprehensive support to assist companies in obtaining RoHS certification:
Accredited testing with advanced equipment: we perform advanced chemical analyses and material/component testing to detect substances prohibited by the RoHS directive using state-of-the-art laboratory technologies to ensure accurate and reliable results.
Detailed material analysis: we offer a complete analysis of materials and components in your products to identify non-conformities and prevent risks related to hazardous substances.
Issuance of official certificates valid throughout the EU: after verification, we issue the RoHS Declaration of Conformity, essential for CE marking and legal product marketing.
Specialized technical consulting for every process stage.
Why choose Analytical Group?
Proven experience in managing RoHS certification processes
Accredited laboratories with cutting-edge equipment
Customized solutions for companies of all sizes and sectors
Complete support: from technical consultancy to certification issuance
By choosing Analytical Group, you have a reliable partner guiding you safely towards full RoHS Directive compliance.
Contact us today for personalized consulting or to request a quote.
