🧭 1) Confirm scope (EEE, categories, exclusions)

What counts as EEE?

EEE is equipment that depends on electric currents/electromagnetic fields to work (or to generate/transfer/measure them), designed for use up to 1000V AC / 1500V DC.

Categorise your product (Annex I)

RoHS groups EEE into 11 categories (including a broad “other EEE” category). Assign the category at SKU/family level and store the decision.

Check exclusions early

RoHS contains defined exclusions (e.g., specific large-scale installations/tools and other special cases). If you rely on an exclusion, keep a short, evidence-based scope memo in the technical file.

🧱 2) Apply the correct compliance unit: “homogeneous material”

RoHS concentration limits apply by weight in each homogeneous material, not the finished product overall. “Homogeneous material” means a material of uniform composition, or a material that cannot be separated into different materials by mechanical actions (e.g., unscrewing, cutting, crushing, grinding, abrasive processes).

Practical impact: Your assessment must go beyond the top-level BOM into solders, coatings, platings, polymers, cable insulation, inks, adhesives, and other relevant material layers.

🧪 3) Restricted substances & maximum concentration limits (Annex II)

RoHS currently restricts 10 substances with maximum concentration values by weight in homogeneous materials:

• Cadmium (Cd): 0.01%
• All others: 0.1% (Lead, Mercury, Hexavalent Chromium, PBB, PBDE, plus four phthalates)

Phthalates (“RoHS 3”) applicability you must apply correctly

Directive (EU) 2015/863 added DEHP, BBP, DBP, DIBP to Annex II. Restrictions apply generally from 22 July 2019, and for medical devices and monitoring & control instruments (including industrial) from 22 July 2021 (with specific spare-part/cable conditions).

🧩 4) Exemptions (Annex III & Annex IV): controlled, specific, expiring

RoHS exemptions are application-specific, listed in Annex III (general EEE) and Annex IV (medical devices & monitoring/control), and are time-limited with defined renewal rules.

What your exemption governance must include

• Map exemptions to specific parts + specific use case (never “whole product”).
• Track expiry dates and affected SKUs; block shipments if an exemption lapses.
• Store technical justification and evidence supporting the exemption use.

✅ What a company must do to comply

🏷️ Step 1 — Assign your legal role(s)

RoHS sets obligations for manufacturers, authorised representatives, importers, and distributors. If you place EEE on the market under your name/trademark (or modify it in a way that can affect compliance), you take manufacturer-level responsibilities.

📄 Step 2 — Build RoHS technical documentation (the technical file)

Manufacturers must be able to demonstrate conformity through documented evidence and controls. Your technical file should be structured, versioned, and complete for each product family/SKU.

Use EN IEC 63000 as your documentation backbone

The EU adopted EN IEC 63000 as the harmonised standard for RoHS technical documentation via Commission Implementing Decision (EU) 2020/659.

What a strong RoHS technical file typically contains

• Product identification (model/SKU, variants, category, intended use)
• Product structure: BOM + evidence mapping down to homogeneous material where needed
• Restricted substance assessment results (Annex II limits) with rationale and supporting evidence
• Supplier declarations and supporting files (material/part declarations, compliance statements, reports)
• Exemptions register (Annex III/IV): mapping, justification, validity period, affected SKUs
• Change control logs (design/material/supplier/process changes) with re-assessment outcomes
• Document control: owners, approvals, revision history, retention location

🧾 Step 3 — Issue the EU Declaration of Conformity (DoC)

Prepare and control the RoHS EU DoC so it stays consistent with the product configuration on the market and is updated when products change.

✅ Step 4 — Affix CE marking (when applicable) and control release

RoHS is part of the EU conformity framework that relies on documentation and conformity declaration; keep CE/DoC supporting documentation kept up to date and retained for the required period after placing products on the market.

🔁 Step 5 — Maintain conformity in series production (not just at launch)

RoHS compliance must remain valid across:

• supplier substitutions
• alternate materials
• manufacturing process changes
• product revisions and new variants

Minimum operational controls

• “No evidence, no release” gate in NPI and ongoing production
• ECO triggers that force RoHS re-check on any BOM/material/supplier change
• Approved parts/materials list with compliant alternates
• Periodic risk reviews for high-risk commodities (solders, PVC, plated metals, FR plastics)

🕵️ Step 6 — Be market-surveillance ready: retention + fast retrieval

Authorities can request documentation. Keep your evidence and documentation controlled, searchable, and retrievable for the required retention period. General EU guidance for CE/compliance documentation highlights 10-year retention expectations (unless legislation specifies otherwise).

📦 What this RoHS compliance service delivers

🧭 Scope & applicability package

• EEE scope confirmation + category assignment (Annex I)
• Exclusion assessment memo (if applicable) with defensible rationale

🧪 Substance & exemptions compliance pack

• Annex II restricted substances checks (homogeneous-material approach)
• Exemptions register (Annex III/IV) with mapping, expiry tracking, and justification library

🗂️ EN IEC 63000-aligned technical file

• Evidence plan (supplier data + risk-based verification)
• Controlled technical file structure aligned to EN IEC 63000 documentation expectations

✅ DoC + release governance

• DoC drafting and controlled approvals
• Change-control triggers so documentation stays accurate across revisions

🧰 How a material compliance management platform supports RoHS (clean, scalable)

• 🧩 Product → part → material structure to support homogeneous-material logic
• 📥 Supplier evidence collection with version control (declarations, attachments, validity windows)
• 🚦 Automated checks against Annex II thresholds and rule-based risk flags
• 🗓️ Exemption expiry calendar with SKU impact mapping
• 📄 Technical file assembly aligned to EN IEC 63000 documentation expectations
• ✅ Controlled DoC/release workflows with traceable approvals and retrieval-ready history

⭐ Why ComplyMarket is the best-ever solution for RoHS compliance

ComplyMarket’s Material Compliance management and reporting platform is purpose-built for RoHS: it centralizes restricted-substance evidence, enforces consistent workflows, and keeps documentation continuously ready for customer requests and market surveillance.

• RoHS-ready product data model: manage products → parts → materials so homogeneous-material compliance becomes operational, not theoretical.
• Supplier collaboration that closes: structured requests, reminders, revision control, and one source of truth for declarations and supporting files.
• Always-current compliance visibility: dashboards for missing evidence, high-risk parts, and SKUs impacted by exemption expiry or supplier changes.
• EN IEC 63000-aligned documentation packs: assemble and maintain technical files that stay accurate across revisions.
• Governed approvals & traceability: controlled DoC/release workflows with searchable history for fast, confident responses.

If you want a single integrated system to run RoHS Directive requirements end-to-end—reliably, at scale—ComplyMarket is the most complete and effective material compliance solution to achieve and sustain RoHS compliance across your portfolio.