What is the Scope of EU RoHS Compliance?

By Deepa Shetty | Wed Dec 04 2024 | 2 min read

The Restriction of Hazardous Substances Directive — commonly known as RoHS — is one of the most significant product compliance regulations affecting global electronics. Introduced in the EU as Directive 2011/65/EU, RoHS restricts the use of hazardous materials such as lead, mercury, cadmium, and certain flame retardants in electrical and electronic equipment (EEE).

For manufacturers, suppliers, and importers, RoHS is more than a checkbox: it’s a market access requirement. Without compliance, products cannot be legally sold in the European Union and many other jurisdictions that have adopted similar laws.

This guide provides a comprehensive overview of RoHS, including its scope, restricted substances, exemptions, documentation standards, enforcement practices, global equivalents, and how Acquis Compliance helps companies stay audit-ready and competitive.

See how Acquis automates RoHS compliance →

What is EU RoHS?

EU RoHS (Directive 2011/65/EU, often called “RoHS 2”) restricts the use of specific hazardous substances in EEE. It applies to a wide range of products, from household appliances to IT and telecom equipment.

Restricted substances under RoHS include:

Lead (Pb) — 0.1% threshold
Mercury (Hg) — 0.1% threshold
Cadmium (Cd) — 0.01% threshold
Hexavalent chromium (Cr⁶⁺) — 0.1% threshold
Polybrominated biphenyls (PBB) — 0.1% threshold
Polybrominated diphenyl ethers (PBDE) — 0.1% threshold
Phthalates: DEHP, BBP, DBP, DIBP — 0.1% threshold each

The thresholds apply at the homogeneous material level, meaning every distinct material in a component must comply.

Why RoHS Matters for the Electronics Industry

RoHS transformed how products are designed and manufactured. By restricting harmful substances, it reduced risks to human health and environmental safety. But the regulation also created challenges for industry:

Product redesign costs when restricted substances must be removed.
Supplier management challenges when materials change unexpectedly.
Market surveillance risks where non-compliance leads to fines or product withdrawal.

For global manufacturers, RoHS compliance is both a legal requirement and a competitive advantage. Customers, retailers, and investors increasingly expect documented proof of compliance.

Technical Documentation Requirements (EN IEC 63000:2018)

Compliance isn’t just about substance thresholds — it’s also about demonstrating due diligence through technical documentation.

The harmonized standard EN IEC 63000:2018 defines requirements for compiling documentation that shows compliance with RoHS. It requires companies to:

Identify applicable substances.
Collect supplier declarations and test reports.
Maintain a risk assessment of compliance evidence.
Update files as products or suppliers change.

This standard ensures manufacturers follow a consistent, verifiable process — reducing risks during audits or inspections.

RoHS Exemptions

RoHS includes specific exemptions for applications where no technically feasible substitutes exist. Common examples include:

Exemption 6(a): Lead as an alloying element in steel.
Exemption 7(a): Lead in high melting temperature type solders.

Exemptions are:

Time-limited — most expire after a set period.
Product-specific — applying only to certain categories.
Renewable — companies must monitor renewal decisions by the European Commission.

Tracking exemption expiry is critical. Failure to adjust designs when exemptions expire can lead to sudden non-compliance.

Deadlines & Amendments

RoHS has evolved since its first version (2002/95/EC). Key milestones include:

2011: Adoption of RoHS 2 (Directive 2011/65/EU).
2015: Addition of four phthalates.
2019–2021: Enforcement of updated scope (medical, monitoring, and industrial equipment).

Upcoming reviews continue to evaluate new substances and exemption renewals. Companies must maintain visibility into regulatory timelines to stay ahead.

Global RoHS Variants

The influence of EU RoHS extends globally. Many jurisdictions have adopted similar laws with local variations:

Brazil RoHS (Draft) — expected to align closely with EU rules.
Ukraine RoHS — follows EU thresholds with phased adoption.
EAEU RoHS (Eurasian Economic Union) — harmonized standard across member states.
California RoHS — part of U.S. state-level regulations impacting EEE.
India RoHS — aligned with EU substance restrictions, enforced under E-Waste Rules.

For global manufacturers, this means RoHS compliance is not optional — it’s a global passport.

RoHS vs REACH vs Prop 65

While often mentioned together, these regulations serve different purposes:

RoHS — restricts hazardous substances in electronics.
REACH — regulates chemicals broadly across industries, with authorization/restriction pathways.
Prop 65 (California) — requires consumer warnings for listed substances.

Understanding overlaps is essential, as suppliers may need to comply with multiple regimes simultaneously.

Compliance Strategy & Trends

The compliance landscape is dynamic. Recent trends include:

Moving beyond exemptions and redesigning products to eliminate risky materials.
Automating supplier declarations and BoM (Bill of Materials) analysis.
Integrating compliance monitoring into design and procurement processes.

Automating RoHS with Acquis

Manual tracking of exemptions, supplier documents, and deadlines creates bottlenecks. The Acquis RoHS Module provides:

What is the Scope of EU RoHS Compliance

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