- Binding source for DEHP, BBP, DBP, and DIBP additions to the RoHS restricted-substance list.
"amending Annex II to Directive 2011/65/EU"
RoHS supplier evidence helps manufacturers, importers, and distributors check restricted-substance compliance, but it does not supersede the manufacturer's technical documentation, EU declaration of conformity, or CE marking responsibilities.
This page helps decide what to request from suppliers, when to verify it with standards or testing, and how to keep the evidence useful for release reviews and authority requests.
Structured answer sets in this page tree.
Cited legal and guidance references.
A under EU RoHS is supporting evidence, not a shortcut to conformity. First confirm that the product is electrical and electronic equipment (EEE) within Directive 2011/65/EU and is not covered by an Article 2 exclusion. Then link each declaration to the exact material, component, assembly, supplier, Annex II substance, Annex III or IV exemption, test or assessment method, and economic-operator duty it supports.
A can help document whether materials, components, or assemblies are represented as meeting RoHS substance restrictions. It is strongest when it identifies the supplied item, applicable restricted substances, any claimed exemption, revision or date, supplier contact, and the evidence basis behind the declaration.
Do not treat that declaration as the manufacturer's EU declaration of conformity. Under Directive 2011/65/EU, manufacturers must design and manufacture EEE according to Article 4, draw up technical documentation, use the internal production control procedure, issue the EU declaration of conformity when compliance is demonstrated, and affix CE marking to the finished product.
Scope comes first. EEE depends on electric currents or electromagnetic fields for at least one intended function and is designed for no more than 1,000 V AC or 1,500 V DC. Article 2 excludes specified equipment, including equipment for military or space use, means of transport other than non-type-approved electric two-wheel vehicles, large-scale stationary industrial tools, large-scale fixed installations, certain non-road mobile machinery, active implantable medical devices, qualifying photovoltaic panels, and custom-built business-to-business research equipment. Record the exact basis before asking a supplier to declare RoHS status.
Start with the finished EEE and work downward into the BOM. The RoHS restriction applies at homogeneous-material level, so declarations should be granular enough to support the materials, components, and assemblies that make up the product, not just a broad product-family promise.
For each supplier input, record whether it is a material declaration, test report, exemption statement, certificate-like statement, or contractual representation. Then decide whether the evidence is enough for the product's risk profile or whether the item needs additional review against harmonised standards, technical specifications, or targeted testing.
Apply the concentration values to each homogeneous material: 0.01% by weight for cadmium and 0.1% for lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP, and DIBP. Do not average a high-substance coating, solder, or plastic against the rest of an assembly. A matching Annex III or IV exemption changes the conclusion only for the substance, application, category, wording, and validity conditions it covers.
Keep supplier declarations, material evidence, exemption checks, technical documentation, EU DoC responsibilities, and role-specific reviews connected.
Verification is a documented judgment about evidence quality. RoHS does not prescribe one evidence type for every BOM line. A manufacturer may rely on current, item-specific supplier and material information where it resolves the relevant substance and exemption questions; gaps, contradictions, or higher-risk materials may call for test reports, disassembly or screening, supplier corrective action, or substitution review.
EN IEC 63000 is the harmonised RoHS technical-documentation standard referenced by the Commission. It supports an assessment approach for materials, components, and EEE; it should not be reduced to a request for a one-page supplier letter.
Testing also needs a defined question. XRF screening can identify total chromium or total bromine, but those elemental results do not by themselves establish hexavalent chromium, PBB, or PBDE concentrations. Use the relevant substance-specific IEC 62321 method when screening cannot resolve the regulated form.
Supplier verification should answer a practical question: what does this evidence let our company responsibly conclude for our role? The answer is different for a component buyer, finished-product manufacturer, importer, distributor, authorised representative, or private-label seller.
Importers must check that the manufacturer has carried out the conformity assessment, drawn up technical documentation, applied CE marking, and supplied required documents before placing EEE on the Union market. Distributors must act with due care, including verifying CE marking and required accompanying documents. If an importer or distributor places EEE on the market under its own name or modifies it in a way that may affect compliance, manufacturer obligations apply.
A is not evergreen just because the part number has not changed. RoHS technical documentation must account for changes in product design, characteristics, harmonised standards, and technical specifications used to declare conformity.
Refresh the evidence when the supplier changes materials, finishes, manufacturing site, sub-supplier, formulation, exemption claim, test method, or declaration format. Also reopen the file when RoHS restricted substances, exemptions, harmonised-standard references, or market-surveillance questions change.
Set the next review from the evidence, not from an arbitrary annual cycle alone. Review before an exemption deadline, after a timely renewal application or Commission decision, when an old form omits the four phthalates that applied from 22 July 2019 for most EEE and from 22 July 2021 for medical devices and monitoring and control instruments, or whenever the supplied configuration no longer matches the accepted declaration.
"amending Annex II to Directive 2011/65/EU"
"EN IEC 63000:2018"
"series production to remain in conformity"
"renewal of exemptions"
"Restriction of the use of certain hazardous substances"
"total chromium and total bromine"
"Polybrominated biphenyls and polybrominated diphenyl ethers in polymers"
"measure hexavalent chromium"
"Technical documentation for the assessment"