- Binding source for adding DEHP, BBP, DBP, and DIBP to Annex II.
"amending Annex II to Directive 2011/65/EU"
EU RoHS concentration limits are checked by weight in each homogeneous material, not by averaging across the finished electrical or electronic product.
Use this guide to split assemblies into material decisions, apply the Annex II limits, and keep evidence that maps declarations or tests to the actual RoHS assessment level.
Structured answer sets in this page tree.
Cited legal and guidance references.
Under Directive 2011/65/EU, the RoHS restricted-substance limits are tolerated by weight in homogeneous materials. That means a finished product, assembly, cable, connector, coating, solder joint, adhesive, or plastic part has to be assessed at the material level that can or cannot be mechanically separated.
Directive 2011/65/EU defines a homogeneous material as one material of uniform composition throughout, or a material made from a combination of materials that cannot be separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding, or abrasive processes.
Article 4 then applies the Annex II maximum concentration values by weight in homogeneous materials. The practical consequence is simple: do not average a restricted substance across a whole product, populated board, cable, motor, display, or connector when a separable material is the relevant RoHS unit.
Annex II currently lists ten restricted substances and the maximum concentration values tolerated by weight in homogeneous materials. Cadmium has the lower limit; the other listed substances are set at 0.1% by weight.
For material reviews, record the exact substance and threshold that applies. A single RoHS pass statement is weaker than a material-level matrix showing which homogeneous material was assessed against which Annex II limit.
A product can look compliant at total-product level while one material fails at homogeneous-material level. That is why RoHS evidence should be built from the material fractions that matter: the solder in a joint, the copper or alloy conductor in a cable, the insulation compound, a surface coating, a connector plating, or the polymer body of a component.
Sampling and testing decisions should avoid dilution. If a mixed sample combines high-risk and low-risk materials, the result may not answer the RoHS question for the material that can be mechanically separated or that remains a distinct coating or layer.
The strongest RoHS file shows the chain from product scope to material split, Annex II threshold, supplier evidence, test evidence where needed, exemption rationale, and final declaration. The evidence should let a reviewer see why each material was accepted without rebuilding the engineering history.
EN IEC 63000:2018 is the harmonised standard referenced for technical documentation for assessing materials, components, and electrical and electronic equipment under Directive 2011/65/EU. Use it as the organizing frame for supplier declarations, test reports, risk assessment, and conformity documentation.
Map each product version to its separable materials, Annex II thresholds, supplier declarations, test reports, exemptions, and EN IEC 63000 technical documentation so reviewers can trace the RoHS decision without rebuilding the analysis.
"amending Annex II to Directive 2011/65/EU"
"EN IEC 63000:2018"
"Restricted substances referred to in Article 4(1)"
"cannot be disjointed or separated"
"draw up the required technical documentation"
"by weight in homogeneous materials"
"Exemptions are limited in time"
"homogeneous materials are adequately separated"
"Disassembly, disjointment and mechanical sample preparation"