- Binding amendment adding DEHP, BBP, DBP, and DIBP to the RoHS restricted-substance list.
"amending Annex II to Directive 2011/65/EU"
Select RoHS evidence by first confirming EEE scope, homogeneous-material risk, restricted substances, exemptions, and economic-operator role before deciding whether supplier documentation is enough or analytical testing is needed.
Use EN IEC 63000 for the technical-documentation file and IEC 62321 parts for substance-specific sample preparation, screening, and analytical test methods.
Structured answer sets in this page tree.
Cited legal and guidance references.
A RoHS test plan should start with product scope, economic-operator role, homogeneous-material risk, Annex II limits, and any Annex III or IV exemption. Use to document the evidence decision, then select the relevant IEC 62321 sample-preparation, screening, or analytical method only when supplier data, prior evidence, or the unresolved risk makes testing necessary. The manufacturer still owns internal production control, the , CE marking, and the finished-EEE conclusion.
Confirm that the product is electrical or electronic equipment in one of the Annex I categories, including category 11 for other EEE not covered by earlier categories. Then map the bill of materials to homogeneous materials, because Annex II concentration limits are stated at homogeneous-material level rather than finished-product level.
Record the operator role before assigning evidence tasks. Manufacturers carry the core duty to draw up technical documentation, perform internal production control, issue the , and affix CE marking. Importers and distributors also have checks and escalation duties, and an importer or distributor can be treated as the manufacturer if it places EEE on the market under its own name or modifies EEE in a way that may affect compliance.
Do not test an out-of-scope conclusion into existence. First apply the EEE definition, 1,000 V AC and 1,500 V DC design limits, Annex I category, and Article 2 exclusions. Military or space equipment, qualifying transport, large-scale tools or fixed installations, certain non-road mobile machinery, active implantable medical devices, qualifying photovoltaic panels, and custom-built business-to-business research equipment require documented scope facts, not a lab result.
:2018 is the harmonised standard identified by Commission Implementing Decision (EU) 2020/659 for technical documentation supporting RoHS assessment. It is not itself a laboratory test method; it describes the technical-documentation approach used to assess materials, components, and EEE against restricted-substance requirements.
Use IEC 62321 parts when the selected evidence path calls for sample preparation, screening, or substance-specific analysis. IEC 62321-2 covers disassembly, disjointment, and mechanical sample preparation; IEC 62321-3-1:2026 covers that includes lead, mercury, cadmium, total chromium, and total bromine; IEC 62321-6 covers PBB and PBDE in polymers; IEC 62321-7-1 and 7-2 address hexavalent chromium in metal coatings and in polymers or electronics; IEC 62321-8 covers phthalates in polymers.
Treat XRF as screening for the elements it measures. A total-chromium result does not by itself establish the amount of hexavalent chromium, and total bromine does not identify PBB or PBDE. Define how an inconclusive or elevated screen will move to the substance-specific IEC 62321 method before sampling begins.
Write the decision rule before sending samples. Name the , regulated substance, applicable limit or exemption, sample-preparation method, screening or analytical method, laboratory, reporting units, measurement uncertainty, and pass, fail, or inconclusive branch. Do not turn a result close to a legal limit into a pass unless the chosen method and decision rule support that conclusion.
A useful RoHS test-plan decision leaves a reviewer with more than a list of lab tests. It should show why each material was cleared by supplier evidence, documented under , tested under an IEC 62321 method, covered by an exemption, or escalated because the evidence was not strong enough.
Keep the file usable for release gates and authority questions. Directive 2011/65/EU expects the to state that Article 4 requirements have been demonstrated, and the manufacturer assumes responsibility by drawing up that declaration.
Keep RoHS scope decisions, evidence, test methods, owners, and review triggers together for product, legal, quality, procurement, support, and engineering teams.
"amending Annex II to Directive 2011/65/EU"
"Compliance with a harmonised standard confers a presumption"
"The manufacturer is responsible for the conformity assessment"
"draw up an EU declaration of conformity"
"Disassembly, disjointment and mechanical sample preparation"
"Screening - Lead, mercury, cadmium, total chromium and total bromine"
"Cadmium, lead and chromium"
"Polybrominated biphenyls and polybrominated diphenyl ethers in polymers"
"corrosion-protected coatings on metals"
"measure hexavalent chromium"
"Phthalates in polymers by gas chromatography-mass spectrometry"
"specifies the technical documentation"