RoHS, (Restriction of Hazardous Substances), is a regulation impacting the electronics industry and a broad range of electrical products. The original RoHS, formally known as Directive 2002/95/EC, was introduced by the European Union in 2002. This directive restricted the use of six hazardous materials in electrical and electronic products, ensuring that any applicable product sold in the EU market since July 1, 2006, must comply with these restrictions to be RoHS compliant. There have been significant amends to this regulation since 2002. Let's dive deep into the EU RoHS Directive to understand this regulation better.
Introduction: Enacted in 2002. Implementation: Enforced from July 1, 2006. Restricted Substances: Six hazardous materials:
Publication: 2011.
Key Changes:
Introduced a CE-marking directive, making RoHS compliance necessary for CE marking of products.
Added Categories 8 (medical devices) and 9 (monitoring and control instruments) to the scope.
Enhanced compliance recordkeeping requirements, ensuring better traceability and accountability.
Came into effect on January 2, 2013.
RoHS Directive 2015/863:
Key Changes:
Added four additional restricted substances, specifically phthalates, to the original list of six:
Key Changes:
Amendments to substance restrictions, exemption rules, and compliance procedures
Proposed Substances Addition:
The EU RoHS Directive applies to any company manufacturing or importing finished EEE products into the EU. To be considered EEE, products must be either dependent on electrical currents or electromagnetic fields to function properly or else must be equipment used for the generation, transfer and measurement of such currents and fields.
Products covered under the EU RoHS Directive
Products exempted under the EU RoHS directive
A group of specific applications and industries that are exempted from the restrictions on the use of certain hazardous substances under the EU RoHS Directive. The EU RoHS Exemption List currently contains over 100 exemptions, covering a wide range of applications and industries, such as medical devices, military equipment, and the aerospace industry.
EN IEC 63000: This standard guides the technical documentation for evaluating EEE products. It's the only active harmonized standard since EN 50581 was withdrawn.
Compliance with Article 4: Manufacturers and importers must adhere to the directive's requirements, ensuring EEE products don't contain restricted substances beyond specified limits.
Module A in Annex II: Manufacturers must conduct a conformity assessment without involving a notified body. This assessment covers:
To comply with RoHS directives, importers and manufacturers must ensure proper labeling on their products, packaging, and accompanying documents, including CE markings and product traceability information:
Information Required:
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Contact Acquis today to learn more about how their platform can support your RoHS compliance efforts.
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