The RoHS Directive (2011/65/EU)—short for Restriction of Hazardous Substances—is a critical piece of EU legislation aimed at protecting human health and the environment by restricting the use of certain hazardous substances in electrical and electronic equipment (EEE). The directive is part of the EU’s broader strategy for sustainable production and waste reduction, complementing the WEEE and EcoDesign directives.
What is the RoHS Directive?
The RoHS Directive restricts the use of specific hazardous materials found in electrical and electronic equipment. First adopted in 2003 and revised in Directive 2011/65/EU (RoHS 2), with amendments including Directive (EU) 2015/863 (RoHS 3), the regulation requires that manufacturers ensure their products do not exceed maximum concentration values of restricted substances before placing them on the EU market.
RoHS applies to a broad range of electrical and electronic equipment (EEE), including household appliances, IT equipment, consumer electronics, lighting, power tools, toys, and medical devices.
Restricted Substances Under RoHS
Currently, the RoHS Directive restricts the following 10 substances, with maximum concentration values of 0.1% (1000 ppm) by weight in homogeneous materials (except cadmium, which is limited to 0.01%):
- Lead (Pb)
- Mercury (Hg)
- Cadmium (Cd)
- Hexavalent chromium (Cr⁶⁺)
- Polybrominated biphenyls (PBB)
- Polybrominated diphenyl ethers (PBDE)
- Bis(2-ethylhexyl) phthalate (DEHP)
- Butyl benzyl phthalate (BBP)
- Dibutyl phthalate (DBP)
- Diisobutyl phthalate (DIBP)
These substances are commonly used in flame retardants, plastics, solders, paints, and coatings. Their restriction helps to reduce occupational exposure, environmental contamination, and health risks throughout the product lifecycle.
Scope and Categories of Equipment
RoHS applies to eleven categories of EEE, including:
- Large and small household appliances
- IT and telecommunications equipment
- Consumer equipment
- Lighting equipment
- Electrical and electronic tools
- Toys, leisure, and sports equipment
- Medical devices
- Monitoring and control instruments
- Automatic dispensers
- Industrial monitoring and control instruments
- Other EEE not covered above (open scope)
CE Marking and Compliance
Manufacturers must ensure that their EEE products comply with the RoHS restrictions before affixing the CE mark. Compliance involves:
- Performing a conformity assessment
- Preparing technical documentation that demonstrates compliance with the RoHS limits
- Drafting an EU Declaration of Conformity
- Affixing the CE marking
While RoHS does not mandate third-party certification, manufacturers are responsible for ensuring ongoing compliance through material declarations, supplier audits, and testing.
Exemptions and Updates
The directive allows certain exemptions, particularly where no suitable alternatives exist or where safety would be compromised. Common exemptions apply to:
- Certain applications of lead in high-temperature soldering
- Mercury in fluorescent lamps
- Cadmium in electrical contacts
These exemptions are time-limited and subject to review. Stakeholders must monitor the EU Commission’s updates and decisions related to exemption renewals and substance proposals.
Responsibilities of Economic Operators
- Manufacturers: Must ensure product design and materials comply with RoHS, maintain documentation, and apply CE marking.
- Importers: Must verify that non-EU products meet RoHS before placing them on the EU market.
- Distributors: Must ensure the product is CE marked, RoHS-compliant, and accompanied by required documentation.
All parties must be prepared to cooperate with market surveillance authorities and respond to non-compliance incidents.
Contact Us
RoHS compliance is not just a regulatory requirement—it's an essential step in reducing environmental impact and building consumer trust. From material analysis and supplier declarations to technical file preparation and internal audits, our experts can guide you through every stage of the compliance process.
Contact us today for tailored assistance in ensuring your products meet RoHS requirements and maintain full access to the European market.
