Annex IIThresholds

EU RoHS Directive (2011/65/EU) Restricted Substances and Thresholds

10 substances, 2 key thresholds, and the BOM reality behind them.

Output: a restricted-substances risk map + evidence rules you can enforce on suppliers.

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Sorena AI

Published

Feb 21, 2026

Updated

Feb 21, 2026

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Publication metadata

Sorena AI

Published Feb 21, 2026

Updated Feb 21, 2026

Overview

RoHS compliance is measured at the homogeneous material level. That means a product-level compliant claim is never enough; you need a repeatable way to prove that each high-risk homogeneous material in your BOM meets the thresholds or is covered by a valid exemption.

Section 1

The RoHS thresholds (homogeneous material is the unit of control)

Directive 2011/65/EU restricts substances in EEE when the concentration exceeds the maximum tolerated value in homogeneous materials.

In practice, you need a design rule: define homogeneous materials in your BOM model (not just part numbers) and attach evidence at that level.

General threshold: 0.1% by weight in homogeneous material
Cadmium threshold: 0.01% by weight in homogeneous material
Homogeneous material means one material of uniform composition or a material that cannot be separated into different materials by mechanical actions
Evidence approach: supplier declarations + risk-based testing + technical documentation aligned to EN IEC 63000

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Section 2

The 10 restricted substances (Annex II)

RoHS currently restricts six classic substances and four phthalates added by (EU) 2015/863.

Treat this list as a procurement control: every supplier should be able to answer where these substances can appear in their materials.

Lead (Pb) - 0.1%
Mercury (Hg) - 0.1%
Cadmium (Cd) - 0.01%
Hexavalent chromium (Cr(VI)) - 0.1%
PBB - 0.1%
PBDE - 0.1%
DEHP - 0.1%
BBP - 0.1%
DBP - 0.1%
DIBP - 0.1%

Section 3

Where these substances hide in real BOMs (high-risk hotspots)

Most RoHS failures come from predictable hotspots: solders, platings, cables, pigments, soft plastics, and legacy components.

Use this list to prioritise evidence depth and decide where testing is worth the cost.

Solders and terminations: lead in solders; legacy components and rework
Platings and coatings: hexavalent chromium processes and surface treatments
Cables and wire insulation: plasticisers (phthalates) and pigments
Plastics and elastomers: phthalates as plasticisers; brominated flame retardants in legacy polymers
Displays and lamps: mercury historically (validate supplier controls for any relevant components)

Section 4

Phthalates: the implementation reality (EU) 2015/863

The phthalates restriction applies from 22 July 2019 for most EEE and from 22 July 2021 for medical devices and monitoring/control instruments (including industrial).

Your program should separate: (1) phthalate exposure mapping and (2) spare parts/cables carve-outs for repair/reuse of older equipment.

Applies from 22 Jul 2019 (most EEE): DEHP, BBP, DBP, DIBP
Applies from 22 Jul 2021 (medical devices and monitoring/control): same four phthalates
Carve-out: cables/spare parts for repair/reuse/updating of equipment placed on the market before the applicable dates

Section 5

Evidence strategy: declarations, testing, and EN IEC 63000 documentation

Declarations alone can be sufficient for low-risk materials and stable suppliers, but you need verification triggers for high-risk cases.

EN IEC 63000 is the harmonised standard for RoHS technical documentation; use it to structure your file and avoid ad-hoc evidence formats.

Supplier declarations: substances list + homogeneous material coverage + change-notification duty
Risk-based testing: trigger tests for high-risk materials, supplier changes, or inconsistent declarations (use IEC 62321 methods as appropriate)
Technical documentation: maintain an EN IEC 63000-aligned evidence pack per product family and variant

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