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RESTRICTION OF HAZARDOUS SUBSTANCES (RoHS)

Independent technical guidance related to RoHS requirements for electrical and electronic equipment.

Our services support manufacturers in preparing products for EU market access through identification of applicable RoHS requirements, assessment of technical documentation, and coordination of material evaluation and testing activities where required.

RoHS compliance ensures that electrical and electronic equipment does not contain restricted hazardous substances above permitted concentration limits.

our approach to Directive 2011/65/EU

Assessment is typically based on supplier declarations, material disclosures, technical documentation, and laboratory analysis where required.

Electrical and electronic devices

Control panels

Power supplies

Lighting equipment

Consumer and industrial electronics

Electrical assemblies

Directive 2011/65/EU including amendment (EU) 2015/863 (RoHS), as amended, establishes restrictions on the use of certain hazardous substances in electrical and electronic equipment placed on the European market.

The Directive defines requirements related to:

  • Restricted substances and concentration limits 
  • Applicable exemptions 
  • Material and component compliance 
  • Technical documentation and supply chain evidence 
  • CE marking obligations 

 

Assessment is typically based on supplier declarations, material disclosures, technical documentation, and laboratory analysis where required.

RoHS Conformity PROCESS

Scope definition & Readiness Review

Confirmation of applicability under Directive 2011/65/EU including amendment (EU) 2015/863, review of product category, materials, and applicable exemptions.

Documentation and Supply Chain Review

Evaluation of supplier declarations, material disclosures, and technical documentation to identify compliance gaps.

Testing Coordination

Coordination of laboratory analysis where required to support material compliance evidence.

Documentation and Market Readiness

Preparation of documentation suitable for CE technical file and EU market placement.

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WHY DANEM TEST & CERTIFICATE

  • Global Expertise
    International team supporting certification and compliance projects worldwide
  • Independent Assessment
    Transparent and impartial certification, testing, and audit processes
  • Prompt communication and fast response times. Faster certification and testing processes through responsive communication, streamlined workflows, and continuous project oversight
  • Structured Certification Pathways
    Clear project planning from assessment through approval
  • Technical & Regulatory Knowledge
    Support across certification, testing, regulatory requirements, and market access.

FAQ

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Supplier declarations can form an important part of the evidence used to demonstrate RoHS compliance. However, their adequacy depends on factors such as product complexity, supply chain transparency, material risks, and the reliability of the supporting documentation.

In many cases, manufacturers rely on supplier declarations, material declarations, and component compliance statements as part of their technical documentation. However, additional verification, including laboratory testing, may be necessary where documentation is incomplete, high-risk materials are present, or there is insufficient evidence to support compliance.

Manufacturers remain responsible for ensuring that their products comply with the requirements of the RoHS Directive (2011/65/EU) and for maintaining adequate technical documentation to demonstrate conformity.

In many cases, yes. The RoHS Directive (2011/65/EU) applies to a broad range of electrical and electronic equipment, including many types of industrial equipment, control panels, automation systems, monitoring devices, and electrical assemblies placed on the EU market.

Applicability depends on the product’s function, design, and classification under the Directive. While certain categories of equipment may benefit from specific exemptions or exclusions, manufacturers are generally required to ensure that restricted substances do not exceed the permitted concentration limits in homogeneous materials.

A product-specific assessment is recommended to determine whether the equipment falls within the scope of RoHS and to identify any applicable exemptions or compliance requirements.

RoHS exemptions permit the use of certain restricted substances in specific applications where their substitution is technically or scientifically impracticable, or where the environmental, health, or consumer safety impacts of substitution outweigh the benefits.

Exemptions are defined in the annexes of the RoHS Directive (2011/65/EU) and apply only to specific materials, components, or product categories under clearly defined conditions. Manufacturers relying on an exemption must demonstrate that their product meets the scope and requirements of the applicable exemption.

RoHS exemptions are subject to periodic review and may expire, be renewed, amended, or withdrawn. Therefore, manufacturers should regularly verify the validity of any exemptions used and maintain supporting documentation within the technical file.

RoHS compliance is typically supported by a combination of technical documentation and supply chain evidence. This may include supplier declarations, material declarations, certificates of conformity, laboratory test reports, bills of materials (BOMs), and technical specifications for components and materials used in the product.

The documentation should provide sufficient evidence that the restricted substances regulated under the RoHS Directive (2011/65/EU) do not exceed the applicable concentration limits, or that a valid exemption applies.

The exact documentation required depends on the product type, complexity of the supply chain, and the compliance strategy adopted by the manufacturer. All supporting evidence should be maintained as part of the technical documentation used to demonstrate conformity.

Yes, where the RoHS Directive (2011/65/EU) applies to a product, compliance with its requirements is necessary before CE marking can be affixed.

Manufacturers must ensure that the product does not contain restricted substances above the permitted concentration limits, unless a valid exemption applies. Compliance must be supported by appropriate technical documentation and incorporated into the overall conformity assessment process.

Once all applicable EU legislation has been satisfied, including RoHS where relevant, the manufacturer may issue the EU Declaration of Conformity and apply the CE marking to the product.

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