# RoHS compliance for electronics brands
Directive 2011/65/EU (RoHS) restricts hazardous substances in electrical and electronic equipment placed on the EU market, including lead, mercury, cadmium, hexavalent chromium, PBB and PBDE flame retardants and four phthalates, each with permitted thresholds. Brands must track the time-limited exemptions in Annexes III and IV, collect supplier declarations through the whole supply chain, and keep technical documentation that justifies the EU Declaration of Conformity.
Key facts
- RoHS is Directive 2011/65/EU; it applies to electrical and electronic equipment (EEE) in eleven categories listed in its Annex I.
- Ten substances are restricted: lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP and DIBP at a maximum of 0.1% by weight in homogeneous materials, and cadmium at 0.01%.
- The four phthalates were added by Directive (EU) 2015/863, applying from 22 July 2019 for most EEE and from 22 July 2021 for medical devices and monitoring and control instruments.
- A "homogeneous material" means a material of uniform composition throughout that cannot be mechanically separated into different materials: the threshold applies at that level, not to the whole product.
- Annex III (general exemptions) and Annex IV (medical, monitoring and control instruments) list time-limited exemptions where substitution is technically or scientifically impracticable; exemptions expire and are reviewed.
- RoHS is CE-marking legislation: compliant EEE carries the CE marking supported by an EU Declaration of Conformity and technical documentation.
- Non-EU manufacturers act through an EU importer or authorised representative, who shares responsibility for compliance.
1. What RoHS covers
Directive 2011/65/EU restricts hazardous substances in electrical and electronic equipment (EEE) placed on the EU market: the familiar list led by lead, mercury, cadmium, hexavalent chromium, PBB/PBDE flame retardants and certain phthalates, each with permitted thresholds. EEE means equipment dependent on electric currents or electromagnetic fields to fulfil at least one intended function, which covers far more than obvious electronics, from cables and plugs to large appliances. Since 22 July 2019 the directive has applied under "open scope" to all EEE falling within its eleven Annex I categories unless expressly excluded, so check the exclusions in the legal text rather than assuming your product is out of scope.
2. The restricted substances and thresholds
The maximum concentration values apply by weight in homogeneous materials: 0.1% for lead, mercury, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP), and 0.01% for cadmium. Homogeneous material is the critical concept: it means one material of uniform composition throughout that cannot be mechanically disjointed into different materials, so a plastic housing, its coating and the solder inside are assessed separately. The table below summarises the list; confirm exact values in the consolidated directive text.
| Substance | Maximum concentration in homogeneous material |
|---|---|
| Lead | 0.1% |
| Mercury | 0.1% |
| Cadmium | 0.01% |
| Hexavalent chromium | 0.1% |
| Polybrominated biphenyls (PBB) | 0.1% |
| Polybrominated diphenyl ethers (PBDE) | 0.1% |
| DEHP | 0.1% |
| BBP | 0.1% |
| DBP | 0.1% |
| DIBP | 0.1% |
3. Know your exemptions
Annexes III and IV list time-limited exemptions for specific applications where substitution is technically impracticable. Exemptions expire and are reviewed: each carries an expiry date and may be renewed, amended or allowed to lapse following Commission review. Calendar every exemption you rely on, with the review timeline, and track renewal applications in the Official Journal. An expired exemption relied on after its end date is a non-compliance, not a grace period. Where no exemption covers your use, substitution or redesign is the only compliant path.
4. Supplier declarations, not assumptions
Compliance is demonstrated through the supply chain: material declarations, test reports (for example XRF screening plus wet chemistry where needed), and supplier contracts that require notification of changes. A component swap can silently break compliance, which is why change-notification clauses matter more than one-off certificates. Collect declarations at the homogeneous-material level where possible, prioritise high-risk components such as solders, coatings, PVC parts and flame-retarded plastics, and treat any supplier that cannot provide substance data as a risk to be managed, not a detail to ignore.
5. Conformity assessment, CE marking and the declaration
RoHS follows the New Legislative Framework: the manufacturer carries out internal production control, draws up technical documentation, issues the EU Declaration of Conformity and affixes the CE marking. The declaration must identify the product, the manufacturer, the legislation applied and the standards or technical specifications used. RoHS rarely requires a notified body; the burden is on the quality of your documentation and supply-chain evidence. Importers must verify the manufacturer did this work before placing the product on the market, and must keep a copy of the declaration.
6. Technical documentation
Keep the evidence that justifies your Declaration of Conformity: bills of materials, supplier declarations, test reports and exemption justifications. Authorities ask for this file, not for assurances. Organise it per product or product family so that a market surveillance request can be answered quickly: a dated bill of materials linked to declarations and test reports, a list of exemptions relied on with expiry dates, and a record of design or supplier changes with their compliance re-assessment. Retain the documentation for the period the legislation requires after the last unit is placed on the market.
7. Non-EU manufacturers
If you manufacture outside the EU, your importer or authorised representative shares responsibility for ensuring the product complies: align on who holds the evidence. The importer must be able to present the declaration and ensure technical documentation can be made available to authorities; an authorised representative holds the mandate defined in writing. Put this in the contract: who maintains the technical file, who pays for testing, who is notified of component changes, and how documentation transfers if you change partners. Gaps during a switch of importer or representative are your risk.
Compliance checklist
- [ ] Confirm your product is EEE in scope of Directive 2011/65/EU and check the exclusions.
- [ ] Map the bill of materials to homogeneous materials and identify high-risk substances per material.
- [ ] Collect written supplier declarations at material level, with change-notification clauses.
- [ ] Verify with targeted testing (XRF screening plus wet chemistry where needed), especially for new suppliers.
- [ ] Identify every Annex III or IV exemption relied on, with expiry and review dates calendared.
- [ ] Draw up the EU Declaration of Conformity and compile the technical documentation.
- [ ] Affix the CE marking per the graphic rules before placing on the market.
- [ ] Align with your EU importer or authorised representative on evidence custody and change control.
What this means for businesses
For businesses, RoHS compliance is a procurement and data discipline layered on top of design. The expensive failures are rarely laboratory surprises; they are expired exemptions nobody calendared, component swaps nobody flagged, and suppliers who cannot produce declarations when an inspector asks. Build substance data into supplier qualification, calendar every exemption review, and keep the technical file as a living document. However, note that RoHS is one of several substance regimes: REACH Annex XVII, the POPs Regulation and battery rules can restrict the same product independently, so assess the full substance picture, not RoHS alone.
How the EU compares with other markets
The EU restricts ten substances in EEE under RoHS with CE marking and per-material thresholds. China operates its own RoHS with different substance and labelling rules (including the China RoHS labelling and conformity assessment requirements). The United States has no federal RoHS equivalent; substance restrictions arrive through state laws and sector rules. The United Kingdom retains RoHS in UK law with UKCA marking. Test data and supplier declarations collected for EU RoHS can support other regimes but do not satisfy them automatically.
Does RoHS apply to every electronic product?
It applies to EEE within its eleven Annex I categories under open scope, subject to the exclusions in the directive. Check the exclusions in the legal text rather than assuming.
What is a homogeneous material?
A material of uniform composition throughout that cannot be mechanically separated into different materials. Thresholds apply at this level: a coating, a plastic part and solder are each assessed separately.
Can I rely on a supplier's declaration alone?
Declarations are the foundation, but verify high-risk materials and new suppliers with testing, and require contractual change notification. A declaration without change control goes stale.
What happens when an exemption expires?
Relying on an expired exemption is non-compliance. Track review timelines in the Official Journal and plan substitution or renewal applications well before expiry.
Do the phthalate restrictions apply to my product?
The four phthalates (DEHP, BBP, DBP, DIBP) have applied since 22 July 2019 for most EEE, and since 22 July 2021 for medical devices and monitoring and control instruments. Check which date covers your category.
Assumptions and limitations
- This guide summarises Directive 2011/65/EU as amended, including Directive (EU) 2015/863; exemption lists change through Commission decisions.
- Thresholds and exemptions must be confirmed in the consolidated directive text before design decisions.
- This guide does not cover REACH, POPs or battery substance rules, which may apply in parallel.
Official sources
Last verified: 2026-09-29.
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