Directive 2011/65/EU. RoHS Hazardous Substances, Limits & Exemptions.
Electrical equipment must comply with hazardous substance limits. IgeraIndustria provides guidance on substance restrictions, exemptions, documentation requirements, and compliance verification strategies.
RoHS Directive 2011/65/EU: substance compliance and exemption complexity
Manufacturers must demonstrate absence of six hazardous substances. Substance tracking, supplier documentation, and exemption interpretation are compliance challenges.
6 substances
Pb, Hg, Cd, Cr(VI), PBB, PBDE. Yet documentation across global supply chains is inconsistent.
1000 ppm
Threshold per homogeneous material. Determining "homogeneous material" requires expert judgment.
~30 exemptions
Annex III exemptions are time-limited and reviewed periodically. Using exemptions incorrectly is non-compliance.
3 years
Documentation retention minimum. Records must prove substance verification strategy.
Instant guidance on Directive 2011/65/EU compliance
IgeraIndustria locates exact Directive articles, substance limits, exemptions, and documentation requirements.
Scope and product categorization
Detailed guidance on Directive requirements.
Substance limits per homogeneous material
Detailed guidance on Directive requirements.
Annex III exemptions and application
Detailed guidance on Directive requirements.
Supplier verification strategies
Detailed guidance on Directive requirements.
Testing requirements determination
Detailed guidance on Directive requirements.
Declaration of Conformity structure
Detailed guidance on Directive requirements.
Critical articles of Directive 2011/65/EU
These articles define substance limits, exemptions, and compliance verification.
Articles 4 & 5 — Substance Limits
Six hazardous substances restricted to <1000 ppm per homogeneous material (except Hg, Cd, Cr(VI) at <100 ppm). "Homogeneous material" defined as material with uniform composition.
Annex III — Exemptions
~30 exemptions for specific applications (e.g., lead solder in aerospace/medical, mercury in lamps). Exemptions time-limited and reviewed. Manufacturers must document exemption eligibility.
Article 7 — Documentation
Declaration of Conformity required. Material composition documentation. Supplier certificates/declarations. Testing reports if substances present. Retained 3 years minimum.
Article 8 — Corrective Measures
Non-compliance discovered post-market triggers immediate notification, identification of affected units, corrective action, effectiveness verification.
How IgeraIndustria handles RoHS compliance questions
Five steps from compliance question to substance documentation strategy and exemption guidance.
Index your product portfolio and BOM
Upload product specifications, bill of materials, supplier declarations. IgeraIndustria processes them against Directive 2011/65/EU.
Connect your compliance team
Embed in quality systems, Teams, Slack, or WhatsApp.
Ask RoHS compliance questions
"Does my legacy PCB with lead solder qualify for exemption?", "How do I verify cadmium compliance across suppliers?"
IgeraIndustria searches in 2 layers
First in your documentation, then in indexed Directive articles and substance databases.
Response with substance limits and verification strategy
Answer cites substance limits, applicable exemptions, documentation requirements.
Frequently asked questions — Directive 2011/65/EU
What hazardous substances does Directive 2011/65/EU restrict?
Six substances: Lead (Pb) <1000 ppm, Mercury (Hg) <100 ppm, Cadmium (Cd) <100 ppm, Chromium VI (Cr(VI)) <1000 ppm, Polybrominated Biphenyls (PBB) <1000 ppm, Polybrominated Diphenyl Ethers (PBDE) <1000 ppm. Limits apply per homogeneous material. Exemptions exist for specific applications (aerospace, medical devices).
Which products fall under RoHS scope and which are excluded?
Scope: electrical/electronic equipment operating at <1000V AC or <1500V DC. Exclusions: used equipment, spare parts, certain industrial equipment, medical devices (some), monitoring/control instruments. Scope boundaries with industrial control and aerospace equipment are often unclear.
What technical documentation is required for RoHS compliance?
Declaration of Conformity confirming hazardous substance limits. Material composition documentation by supplier. Testing reports if substances are present. Supplier certificates/declarations. Documentation retained for minimum 3 years.
What are the RoHS exemptions and how are they applied?
Annex III lists ~30 exemptions (e.g., lead-based solder in aerospace, mercury in certain lamps). Exemptions are time-limited and reviewed periodically. Using exemptions without eligibility is non-compliance. Manufacturers must document why exemption is claimed.
How do manufacturers verify substance compliance without testing every component?
Risk-based approach: review supplier declarations, material data sheets, IMDS (International Material Data System). Testing required only if manufacturer cannot confirm compliance via documentation. Documentation strategy is key to cost management.
What corrective actions are required if RoHS non-compliance is discovered?
Manufacturer must immediately notify competent authorities, identify affected units, take corrective measures (redesign, recall, withdraw). Document all actions. For systematic non-compliance, penalties can include market access denial and financial liability.
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