RoHS Directive 2011/65/EU: Restriction of Hazardous Substances in Electrical Equipment
RoHS Directive 2011/65/EU restricts 10 hazardous substances — including lead, mercury, cadmium and four phthalates — in electrical and electronic equipment. IgeraIndustria answers every RoHS compliance question: substance limits, exemption applicability, supplier material declarations and technical file content. Your team gets the exact article in seconds.
RoHS 2011/65/EU: 10 restricted substances, MCV limits and EEE categories for compliance
RoHS compliance requires knowing the maximum concentration value (MCV) for each substance, identifying whether any exemptions apply, obtaining material declarations from the entire supply chain, and maintaining a technical file. Non-compliance means market withdrawal and fines up to €300,000 in some EU Member States.
10 restricted substances
Lead, mercury, cadmium, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP and DIBP. Each has a maximum concentration value (MCV) measured in homogeneous materials. Cadmium has the strictest MCV at 0.01%.
0.1% maximum (Cd: 0.01%)
The MCV for 9 of the 10 substances is 0.1% by weight in homogeneous material. Cadmium (Cd) has a stricter MCV of 0.01%. «Homogeneous material» means a material that cannot be mechanically disjointed into different materials.
Fine up to €300,000
Non-compliance with RoHS in some EU Member States carries fines up to €300,000 per infringement. Repeat violations can lead to criminal liability. Market surveillance authorities actively test EEE sold in the EU.
The most common compliance gaps are: applying exemptions that have expired or do not cover the specific application, accepting supplier material declarations without verifying their scope, and failing to update the technical file when the BOM changes. IgeraIndustria identifies these risks in seconds so the compliance team can address them before market surveillance does.
Instant RoHS compliance query by requirement
IgeraIndustria locates the exact RoHS 2011/65/EU requirement for each question and responds with the applicable MCV limit, exemption status and technical file requirement.
RoHS substance MCV verification
IgeraIndustria identifies the MCV for each of the 10 restricted substances and clarifies the «homogeneous material» concept. It explains how XRF screening and ICP-OES wet chemical analysis are used to verify substance levels against the applicable MCV.
RoHS exemption applicability check
RoHS Annex III and IV contain over 40 exemptions for specific applications where substitution is not technically or scientifically feasible. IgeraIndustria checks whether a specific exemption applies to your application and its current expiry date, since expired exemptions are no longer valid.
EEE category scope determination
IgeraIndustria determines which of the 11 EEE categories applies to your product and when the restriction entered into force (some categories had delayed application dates). It identifies products in the «open scope» (Category 11) that became subject to RoHS from July 2019.
Supplier material declaration management
RoHS compliance depends on the entire supply chain. IgeraIndustria explains how to request and validate supplier material declarations (IPC-1752A Class D or equivalent), which components require testing rather than declarations, and how to handle suppliers who cannot provide compliant declarations.
RoHS and REACH interaction
RoHS restricts specific substances in EEE. REACH restricts substances of very high concern (SVHC) across all products. Some substances appear in both (e.g. phthalates DEHP, BBP, DBP, DIBP under both RoHS and REACH). IgeraIndustria identifies the interaction and the stricter obligation for each substance.
RoHS technical file and DoC content
The RoHS technical file must enable verification of conformity and must include: product description, BOM with homogeneous material breakdown, material declarations, test reports, and the DoC. IgeraIndustria details the mandatory content and how the RoHS DoC relates to the CE marking DoC for other applicable directives.
Complete RoHS 2011/65/EU compliance support
From BOM analysis through supplier qualification, test strategy and technical file preparation, IgeraIndustria supports the compliance team at every stage of RoHS conformity demonstration.
Homogeneous material identification
IgeraIndustria explains which materials qualify as «homogeneous» under RoHS and how to break down complex components (e.g. a PCB with solder, laminate, copper tracks and surface finish) into their homogeneous material constituents for MCV assessment.
Lead-free solder and exemption 6(a)
Exemption 6(a) covers lead in solder for servers, storage and network infrastructure. It has been renewed but has specific application scope and conditions. IgeraIndustria checks whether your product qualifies for 6(a) or must use lead-free solder, and what the renewable exemption schedule means for your next product generation.
Phthalate compliance for cables and gaskets
DEHP, BBP, DBP and DIBP — added to RoHS from July 2019 — are commonly found in PVC cables, gaskets, coatings and adhesives. IgeraIndustria identifies which components in your product are at risk and what alternative plasticisers are available for compliant formulations.
Hexavalent chromium in surface treatments
Cr(VI) is used in chromate conversion coatings for aluminium and zinc die-castings. RoHS restricts Cr(VI) above 0.1% in homogeneous materials. Exemption 6(b) covers chromate conversion coatings on non-electrical steel parts. IgeraIndustria identifies which surface treatments require substitution and which qualify for exemptions.
Mercury in lighting and displays
Mercury is used in certain lamps and backlit displays. RoHS Annex III Exemptions 1, 2, 3 and 4 series cover specific lamp types with defined mercury content limits. IgeraIndustria identifies which exemptions apply to your lighting or display product and their current expiry status.
RoHS re-use and spare parts obligations
Re-used EEE and spare parts do not need to comply with RoHS substance restrictions if they were originally placed on market before the restrictions applied, subject to conditions. IgeraIndustria clarifies the repair and re-use provisions and their documentation requirements.
The 4 key requirements of RoHS 2011/65/EU
These requirements define what manufacturers must demonstrate before affixing CE marking to electrical and electronic equipment placed on the EU market.
Substance restriction — 10 substances below MCV
All 10 restricted substances must be below their MCV in every homogeneous material of the product, unless a specific exemption in Annex III or IV applies. The MCV applies to homogeneous material, not to the component or the product as a whole. A component may contain multiple homogeneous materials, each of which must individually comply. Lead-free solder (Sn-Ag-Cu alloys) must contain <0.1% Pb.
Exemption application — Annex III and IV
Annex III lists exemptions for all EEE categories. Annex IV lists exemptions for medical devices and monitoring/control instruments. Exemptions are time-limited and must be renewed. If an exemption expires while your product is on market, the product must be reformulated or withdrawn. IgeraIndustria tracks expiry dates and renewal status for all active exemptions.
Technical documentation and DoC
Manufacturers must draw up technical documentation enabling RoHS conformity to be assessed, and keep it for 10 years after the last product is placed on market. The DoC must state that the product complies with RoHS 2011/65/EU. The CE marking on EEE implicitly covers RoHS — there is no separate RoHS mark. No Notified Body is required; the manufacturer self-declares.
Supply chain due diligence
RoHS Art. 4 requires that EEE placed on market does not contain the restricted substances above MCV. The manufacturer is responsible for the entire supply chain. In practice, this means obtaining material declarations from component suppliers, performing risk-based XRF screening of incoming materials, and conducting ICP-OES wet chemistry testing when XRF results are borderline.
How IgeraIndustria works for RoHS 2011/65/EU
Five steps from loading your EEE compliance documentation to receiving an answer with the exact RoHS article, MCV limit, and exemption status.
Index your EEE compliance documentation
Upload your material declarations, BOM, test reports, existing DoCs and supplier qualification records. IgeraIndustria processes them together with the full RoHS 2011/65/EU text, Annex III exemptions list and Directive 2015/863/EU phthalate amendment in under 24 hours.
Connect the assistant to your compliance team
Embed it in your compliance portal, Teams, Slack or as a standalone tool for the product compliance and supply chain team. One line of code. Compatible with any PLM or document management system.
Ask in plain language
«Does exemption 6(a) cover our server power supply lead solder?», «Our PCB XRF shows 0.08% Pb — is that compliant?», «Our cable supplier uses PVC with DEHP — what are our options?»
IgeraIndustria searches across 2 knowledge layers
First in your internal material declarations, test reports and BOM data, then in the indexed RoHS 2011/65/EU directive text including Annexes III and IV exemptions and the 2015/863/EU phthalate amendment.
Answer with directive reference, MCV limit and exemption status
The response cites the applicable RoHS article or annex, states the MCV for each substance, identifies whether any exemption applies and its current expiry date, and flags the most common non-conformities that market surveillance laboratories detect.
IgeraIndustria in action — RoHS 2011/65/EU phthalate compliance check
RoHS phthalate restriction applicability for PVC cable resolved in under 3 seconds with MCV limits and substitution guidance.
Product Compliance Manager
Our cable supplier declares DEHP content at 0.08% in the PVC insulation. Is this compliant with RoHS and does any exemption apply?
IgeraIndustria
RoHS 2011/65/EU — DEHP Phthalate Compliance Result
DEHP MCV = 0.1% | Declared level = 0.08% → BELOW MCV
- • DEHP at 0.08% in PVC insulation (homogeneous material): compliant — below 0.1% MCV
- • Added by Directive 2015/863/EU; applies to EEE placed on market from 22 July 2019
- • No specific exemption needed — substance is below MCV
Recommended action:
- • Request IPC-1752A Class D declaration from supplier confirming DEHP < 0.1%
- • If cable has multiple insulation layers, each is a separate homogeneous material — verify all layers
⚠️ Verify also BBP, DBP and DIBP in the same PVC compound — all four phthalates must be below 0.1% individually
✓ RoHS 2011/65/EU Annex II + Directive 2015/863/EU · Confidence: 99.4%
200
employees, industrial electronics manufacturer
-80%
time resolving exemption applicability questions
0
RoHS enforcement actions since implementation
We manufacture industrial control panels with hundreds of components sourced globally. Managing RoHS compliance across the supply chain — including the 2019 phthalate additions — was consuming our compliance team. IgeraIndustria answers exemption and MCV questions instantly with the exact directive article. We have had zero RoHS enforcement actions since implementing it.
*Representative testimonial based on results from real customers
Frequently asked questions — RoHS 2011/65/EU
Which 10 substances are restricted by RoHS 2011/65/EU?
The 10 restricted substances and their maximum concentration values (MCV) in homogeneous materials are: Lead (Pb) 0.1%, Mercury (Hg) 0.1%, Cadmium (Cd) 0.01%, Hexavalent chromium (Cr VI) 0.1%, Polybrominated biphenyls (PBB) 0.1%, Polybrominated diphenyl ethers (PBDE) 0.1%, Bis(2-ethylhexyl) phthalate (DEHP) 0.1%, Butyl benzyl phthalate (BBP) 0.1%, Dibutyl phthalate (DBP) 0.1%, Diisobutyl phthalate (DIBP) 0.1%. The four phthalates were added by the RoHS recast (Directive 2015/863/EU) and apply to EEE placed on the market from 22 July 2019.
Which categories of electrical and electronic equipment (EEE) must comply with RoHS?
RoHS 2011/65/EU applies to all 11 categories of EEE: large household appliances, small household appliances, IT and telecommunications equipment, consumer equipment, lighting equipment, electrical and electronic tools, toys, leisure and sports equipment, medical devices (from July 2014 for IVD, July 2016 for active implantable), monitoring and control instruments (from July 2016/2017), automatic dispensers, and any other EEE not covered in categories 1–10 (from July 2019, the open scope). Military equipment and large-scale stationary industrial tools are excluded.
How does a manufacturer demonstrate RoHS compliance?
RoHS compliance is demonstrated through the technical documentation included in the Technical File: material declarations from suppliers (IPC-1752A or similar), test reports from accredited laboratories showing restricted substances are below MCV (ICP-OES or XRF screening followed by wet chemical analysis), BOM (Bill of Materials) with homogeneous material breakdown, and a written EU Declaration of Conformity. The CE marking on EEE implicitly covers RoHS compliance. No Notified Body is required — the manufacturer self-declares through the DoC.
IgeraIndustria RoHS 2011/65/EU Plans
No lock-in. Cancel whenever you want.
Starter
For EEE manufacturers that need to verify RoHS substance limits, check exemption applicability and prepare compliant technical files without months of regulatory research.
- RoHS 2011/65/EU pre-indexed
- 10 substances MCV checker
- Annex III exemption status tool
- 1,000 queries/month
- Widget for the compliance team
- Email support
Professional
For companies with complex supply chains that need ongoing RoHS compliance support including phthalate management and exemption renewal tracking.
- RoHS + internal material declarations indexed
- Supplier declaration gap analysis
- Exemption expiry tracking
- 5,000 queries/month
- Directive update alerts
- Priority support
Enterprise
For industrial groups with multiple EEE product lines requiring integrated RoHS, REACH and WEEE compliance management.
- Multi-directive (RoHS + REACH + WEEE)
- Multi-product line management
- Market surveillance response kit
- Unlimited queries
- 99.9% uptime SLA
- Dedicated customer success
Comply with RoHS 2011/65/EU. No more substance surprises before CE marking.
- Free 14-day trial — no credit card required
- Full RoHS 2011/65/EU text, Annex III exemptions and 2015/863/EU phthalate amendment pre-indexed from day 1
- Upload your material declarations, BOM and test reports
- 10 substances MCV checker and exemption expiry tracker