EU RoHS

Materials & Environmental

Restriction of Hazardous Substances in Electrical and Electronic Equipment (Directive 2011/65/EU)

240+ Exemptions. 10 Substances. Thousands of Parts. One Compliance Nightmare You Can Eliminate.

EU RoHS compliance requires you to prove that every electrical and electronic product you sell into Europe contains less than 0.1% (or 0.01% for cadmium) of 10 restricted substances—across every homogeneous material in every component. The catch? Exemptions expire constantly, suppliers send inconsistent declarations, and your customer just asked for proof by Friday. Certivo automates RoHS evidence collection from suppliers, validates declarations against current thresholds and exemptions, and generates audit-ready compliance packages in hours—not weeks.

Regulation Overview

Jurisdiction

European Union (+ UK RoHS post-Brexit)

Regulatory Body

European Commission, enforced by EU Member State authorities

Regulation Number

Directive 2011/65/EU (RoHS 2), amended by Directive 2015/863 (RoHS 3)

Effective Date

July 21, 2011 (RoHS 2); July 22, 2019 (4 phthalates added)

Official Source

EUR-Lex Directive 2011/65/EU

Key Threshold

0.1% (1000 ppm) for most substances; 0.01% (100 ppm) for cadmium

What is EU RoHS?

The Restriction of Hazardous Substances (RoHS) Directive is one of the foundational EU chemical regulations for electrical and electronic equipment. RoHS 2 (Directive 2011/65/EU) restricts 10 hazardous substances and requires CE marking, technical documentation, and EU Declarations of Conformity.

RoHS applies to nearly all EEE across 11 product categories. If your product uses electricity or electromagnetic fields and is sold in the EU, RoHS almost certainly applies.

The challenge: compliance must be demonstrated at the homogeneous material level—not the product level. A single PCB contains hundreds of homogeneous materials, each requiring validation against all 10 substances. With 240+ exemptions expiring on rolling schedules, hazardous substance tracking is a full-time job.

Key Components / Sub-Frameworks

• Obligation: Triggers substance threshold compliance for all EEE
• Annex II - Restricted Substances: Lists the 10 restricted substances and their maximum concentration values
• Obligation: Time-limited allowances requiring tracking and renewal
• Annex III - General Exemptions: Exemptions applicable to all EEE categories (lead solders, etc.)
• Obligation: Category-specific exemptions with separate expiration dates
• Annex IV - Medical/IMCI Exemptions: Exemptions specific to medical devices and monitoring/control instruments
• Obligation: Mandatory marking before placing product on market
• CE Marking Requirement: RoHS compliance must be declared as part of CE marking for EU market access
• Obligation: Prepare and sign EU DoC for each product type
• EU Declaration of Conformity: Required documentation declaring product compliance with RoHS
• Obligation: Compile and retain compliance evidence file
• Technical Documentation: Evidence file demonstrating compliance, available for 10 years

Critical Exemptions Expiring 2025-2027: Is Your Product Portfolio at Risk?

Multiple Annex III exemptions for lead in solders (7(a), 7(c)-I, 7(c)-II) and lead in alloys (6(a), 6(b), 6(c)) have been renewed with new expiry dates in June-December 2027. Some exemptions like 6(a) and 6(b) will NOT be renewed and expire 12-18 months after delegated directives enter into force. Renewal applications for exemptions expiring June 30, 2027 must be submitted by December 30, 2025. If your products rely on these exemptions, you need to know now—not when your shipment is held at the border.

Key Compliance Requirements

Who Must Comply

• Manufacturers of electrical and electronic equipment sold in the EU
• Importers bringing EEE into the EU market
• Distributors selling EEE in the EU (verification obligations)
• Authorized representatives acting on behalf of non-EU manufacturers
• Any company whose components are integrated into EEE products
• Retailers and online sellers placing EEE on the EU market

Key Thresholds

0.1% (1000 ppm)

Maximum concentration for 9 of 10 restricted substances

0.01% (100 ppm)

Maximum concentration for cadmium (Cd)

Homogeneous material

Level at which threshold applies—not product or component level

10 years

Technical documentation retention period

Core Obligations

1. Substance Compliance: All 10 substances below threshold in every homogeneous material
   • DEADLINE: Before placing on market
2. CE Marking: Affix CE mark indicating RoHS compliance
   • DEADLINE: Before placing on market
3. EU Declaration of Conformity: Prepare and sign EU DoC for each product type
   • DEADLINE: Before placing on market
4. Technical Documentation: Compile evidence file demonstrating compliance
   • DEADLINE: Retain for 10 years
5. Supply Chain Diligence: Collect supplier declarations for all components
   • DEADLINE: Ongoing

RoHS-Specific Pain Points

The Exemption Expiration Trap

Your product has been compliant for years because exemption 7(a) covers the lead solder in your power supply. But that exemption expires June 30, 2027—and the renewal timeline means you need to act by December 2025. Do you know which of your 3,000 components rely on which exemptions? One overlooked expiration means your CE marking is invalid.

The Declaration Chaos

You've requested RoHS declarations from 200 suppliers. 40% haven't responded. 30% sent PDFs that don't match your part numbers. 15% sent declarations referencing the old 6-substance RoHS. 10% sent expired certificates. Your compliance engineer spends 80% of their time chasing documents and 20% actually validating compliance.

The Homogeneous Material Problem

RoHS compliance isn't at the product level—it's at the homogeneous material level. The solder on pin 47 of a 256-pin BGA is a separate compliance unit from the lead frame inside the same component. Your supplier's declaration says "RoHS compliant" but doesn't tell you actual substance concentrations or which exemptions they're claiming. When your customer asks for evidence, "trust us" isn't going to cut it.

The Multi-Jurisdiction Multiplier

Your customer in Germany needs RoHS evidence. UK needs UK RoHS. China needs China RoHS. Korea needs Korea RoHS. Same 10 substances, different documentation requirements, different formats, different languages—and they all want it this week.

Certivo In Action

RoHS Workflow

GET EVIDENCE IN

Collect RoHS Supplier Declarations from Every Supplier—Without the Chase
CORA launches automated, multilingual campaigns that achieve 95% supplier response rates, compared to the industry average of 20-30%.

• Launch RoHS declaration campaigns to hundreds of suppliers with one click
• CORA follows up automatically in suppliers' native languages until they respond
• Accept declarations in any format—PDFs, Excel, IPC-1752, custom templates
• Auto-crawl supplier websites to retrieve existing declarations without asking

MAKE SENSE OF IT

Know Instantly When Products Exceed RoHS Thresholds CORA-driven compliance intelligence extracts substance data, validates against RoHS limits, and flags issues before they become problems.

• CORA parses supplier declarations to extract substance concentrations to CAS number level
• Validates every material against all 10 RoHS substance thresholds automatically
• Tracks exemption dependencies and alerts you before exemptions expire
• Flags inconsistent, incomplete, or expired declarations for human review

PROVE COMPLIANCE OUT

Respond to Customer Requests in Hours, Not Weeks Generate audit-ready RoHS packages and EU Declarations of Conformity instantly from validated supplier data.

• One-click generation of customer-specific RoHS evidence packages
• Include EU Declarations of Conformity, supplier declarations, and test reports
• Export in any format—PDF bundles, Excel summaries, or direct system integrations
• Complete audit trail documents every validation step for regulatory defense

One Declaration. Ten Substances. 240+ Exemptions. Complete Visibility.

Certivo doesn't just collect declarations—it understands them. CORA-powered regulatory intelligence parses supplier documents to substance level, validates against current RoHS thresholds, tracks exemption dependencies, and alerts you before compliance gaps appear. When your customer needs proof, you generate audit-ready packages instantly—not after weeks of digging through email archives.

• 10-Substance Validation
• Exemption Expiry Tracking
• Multi-Jurisdiction Support
• Homogeneous Material Mapping
• One-Click Audit Packs

Features Tabs

• Declaration Collection: Certivo's automated campaigns achieve 95% response rates vs. 20-30% with manual outreach.
• Substance Extraction: Every substance. Every concentration. Every exemption. Extracted automatically from any document format.
• Threshold Monitoring: Always validated against current thresholds and exemption status—not your last audit.
• Exemption Tracking: Know which exemptions your products depend on—and when they expire—before compliance gaps appear.
• Customer Response: Generate RoHS evidence packages in hours instead of 4-6 weeks.

Related Regulations

• REACH (SVHC): Overlapping substance concerns; some RoHS substances are also SVHCs
• WEEE Directive: Sister directive for waste management; linked scope definitions
• UK RoHS: Post-Brexit mirror regulation with separate enforcement
• China RoHS: Similar substance restrictions with different labeling/marking
• California Prop 65: Overlapping lead and cadmium concerns
• PFAS Regulations: Emerging restrictions may affect EEE components

Managing RoHS alongside related regulations eliminates duplicate supplier requests. Certivo validates one submission against multiple frameworks.

Industries Most Impacted

Electronics Manufacturing: Your Pain Point
Thousands of components per product, each with multiple homogeneous materials

Industrial & Heavy Equipment: Your Pain Point
Long product lifecycles mean tracking exemption changes over decades

Medical Devices & Equipment: Your Pain Point
Category 8 has specific exemption rules (Annex IV)

Automotive Manufacturing: Your Pain Point
Tier 1 suppliers face OEM RoHS requirements stricter than regulation

Aerospace & Defense: Your Pain Point
High-reliability applications often depend on lead solder exemptions

Consumer Goods: Your Pain Point
High SKU counts and fast product cycles

Monitoring & Control Instruments: Your Pain Point
Category 9 IMCI products have specific rules and exemptions

Energy & Infrastructure: Your Pain Point
New EU Battery Regulation overlaps with RoHS