- 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.
This guide helps 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 each , not by averaging across the finished EEE. A product, assembly, cable, connector, coating, solder joint, adhesive, or plastic part must therefore be split at the level that can or cannot be mechanically separated.
Directive 2011/65/EU defines a 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 applies the Annex II maximum concentration values by weight in homogeneous materials. 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. The test asks whether the materials can be disjointed by mechanical action, not whether separation is convenient, economical, or part of normal product use.
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. The 0.1% limit equals 1,000 mg/kg and the 0.01% cadmium limit equals 100 mg/kg, but keep the legal percentage in the conformity record and confirm that any laboratory unit conversion uses the same material basis.
A product can look compliant at total-product level while one material fails at homogeneous-material level. Build the RoHS evidence from the relevant material fractions: 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 a mechanically separable material or distinct coating. Record the sample boundary, preparation method, method capability, reporting limit, and which the result represents.
A reviewable 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 cited harmonised standard for technical documentation used to assess materials, components, and electrical and electronic equipment under Directive 2011/65/EU. Use it to organise supplier declarations, test reports, risk assessment, and conformity documentation, while keeping the product-specific material decisions and unresolved evidence gaps visible.
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"
"Exemptions are limited in time"
"homogeneous materials are adequately separated"