RoHS
The ten restricted substances and their limits, why homogeneous material is the unit that matters, and what a market surveillance authority asks a manufacturer to produce.
RoHS is Directive 2011/65/EU, restricting ten substances in electrical and electronic equipment placed on the EU market. Lead, mercury, hexavalent chromium, PBB, PBDE and four phthalates are limited to 0.1% by weight in each homogeneous material, and cadmium to 0.01%. Conformity is self-declared through CE marking, an EU declaration of conformity and technical documentation.
Restricts lead, mercury, cadmium, hexavalent chromium, and several flame retardants and phthalates in electrical and electronic equipment.
European Union
Equipment dependent on electric currents or electromagnetic fields, across the categories in Annex I, which since the open category took effect covers essentially all electrical and electronic equipment not specifically excluded. Importers and distributors carry their own obligations, so a US manufacturer's EU importer is on the hook whether or not it was involved in the design.
There is no third-party certification and no notified body. The manufacturer performs internal production control, draws up technical documentation, issues an EU declaration of conformity and affixes the CE marking on its own authority. The declaration and the technical documentation must be kept for ten years after the equipment is placed on the market.
Anyone placing electrical or electronic equipment on the European market, and the suppliers who provide components into it.
| Requirement | Module | What It Does |
|---|---|---|
| Supplier declarations stored against the part | Inventory | A RoHS file is built almost entirely out of supplier statements, test reports and material declarations for purchased components. Those documents attach to the item and to the receiving lot they arrived with, so the evidence you held for a given part number at a given date is on the record that bought it. WorkCell keeps the paper you collected and makes it findable. That is the half of a RoHS file that most often goes missing, because the declaration arrives as an email attachment two years before anyone needs it to defend a declaration of conformity. |
| Which components are in which product revision | Engineering | Bills of material are versioned and effective-dated, and a revision supersedes rather than overwrites, so a unit built before a component change resolves to the parts it actually contained. RoHS declarations are made per product and have to match the build, which is where an undocumented part substitution does the damage. WorkCell answers which revision shipped when, and rolls the declarations held against each component up through the bill that build actually used, so you can tell whether a declaration signed in March covers the units that left in September. |
| Lot and serial genealogy for a recall decision | Inventory | Article 7 requires a manufacturer whose equipment is non-compliant to take corrective measures, and where appropriate to withdraw or recall it. That decision needs a scope. Lot and serial genealogy holds through issues, completions and shipments, so a bad reel of connectors resolves to the units it went into and the customers who received them rather than to a guess at date ranges. |
| Receiving inspection against the declared part | Quality | Inspection templates and AQL sampling plans define what gets checked at receipt and the results are recorded against the lot. Where a programme includes XRF screening of incoming material, the result can be recorded as an inspection result on the lot, and the REST API brings readings in from the analyser itself so the screening record lands against the lot it tested rather than in a separate spreadsheet. |
| Nonconformance when a declaration turns out wrong | Quality | A supplier change notice or a failed screen is a quality event against specific lots. Severity-classified nonconformances record it with the disposition, and an 8-D corrective action carries containment, root cause and verification of effectiveness. What the directive then asks for, notification of the authorities of the member states where the equipment was made available, is a regulatory action the record supports rather than performs. |
| Supplier of record for each component | Purchasing | A supplier catalog holds what each vendor is approved to supply and purchase orders are written against it, with receipts tied back to the lot. Most RoHS failures trace to a second-source part that nobody re-declared, so knowing which approved source actually supplied a given lot is the useful record. Chasing declarations from unresponsive suppliers remains a process you run outside the system. |
A signed declaration naming the product, the manufacturer, the directive, the harmonised standard applied for the technical documentation, and the person who signed for the manufacturer. It is a one-page legal statement, and the authority reads it against the product in front of it. The declaration and the technical documentation behind it attach to the item and the revision they cover, so the statement you signed and the evidence that supports it resolve to the same product.
The documentation behind the declaration: product description, design and manufacturing data, the compliance assessment per component or material, and the supplier evidence. It has to be retained ten years after the equipment was placed on the market, which is longer than most product lifecycles. WorkCell retains transactional and document history; the technical file itself is maintained in your own system.
The limits apply to each material of uniform composition that cannot be separated by mechanical means, so a plating, a solder, an insulation and a wire core are each assessed separately. A declaration for a whole component is not evidence by itself. The authority follows the data down to that level, and the substance analysis behind it does not come from WorkCell.
Annex III lists general exemptions and Annex IV covers medical devices and monitoring and control instruments, each written narrowly and each with an expiry date that renewal applications may or may not extend. If you rely on one, expect to show the exact wording, why your use falls inside it, and that it was still valid. The exemption you claimed and its expiry attach to the item that relies on it, so the claim and the units it covers sit on one record.
Article 7 requires equipment to bear a type, batch or serial number so a non-compliant unit can be identified, with the manufacturer's name and address on the product or its packaging. Serial assignment at completion in WorkCell supports the record side. Getting the marking onto the physical product and the address onto the label is a manufacturing and labelling control you own.
What are the ten RoHS restricted substances and their limits?
Lead, mercury, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers, and the four phthalates DEHP, BBP, DBP and DIBP are each limited to 0.1% by weight in homogeneous material. Cadmium is limited to 0.01%. Those values are the maximum concentrations tolerated, set out in Annex II of the directive.
What counts as a homogeneous material?
One material of uniform composition throughout, or a combination of materials that cannot be separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding or abrasion. A plating, a solder joint and a cable insulation are each separate homogeneous materials, and each is assessed against the limit on its own.
Does RoHS require third-party testing or certification?
No. RoHS has no notified body and issues no certificate. The manufacturer self-declares through internal production control, drawing up technical documentation, issuing an EU declaration of conformity and affixing CE marking. Testing is one way to support the file, not a legal requirement in itself.
Does WorkCell screen a bill of material for RoHS compliance?
WorkCell stores supplier declarations and test reports against the item and the receiving lot they arrived with, versions the bill of material the product was actually built to, rolls those declarations up through that build, holds the exemption claimed on the item that relies on it, and resolves genealogy forward to the units a suspect lot went into.
How long do we keep RoHS documentation?
Ten years after the equipment is placed on the market, for both the EU declaration of conformity and the technical documentation behind it. That obligation outlives most product programmes, so decide where the file lives before the engineer who built it moves on, and keep the supplier evidence with it.
Keep the records as the work happens.
Tell us how your team keeps supplier declarations tied to the parts they cover and we will tell you straight which of that WorkCell holds and where you still need a substance tool.