What is the difference between RoHS 1 and RoHS 2?

Directive 2002/95/EC (RoHS 1) was a transposed directive whose scope tracked the WEEE directive (eight categories), which produced significant ambiguity for hybrid or mixed products. Directive 2011/65/EU (RoHS 2) is a recast aligned with the New Legislative Framework: CE marking conditional on RoHS compliance, EU declaration of conformity, an open category 11 covering all electrical and electronic equipment not addressed elsewhere, and obligations specific to economic operators (manufacturer, authorised representative, importer, distributor).

What are the ten restricted substances and their limits?

Annex II of Directive 2011/65/EU, as amended by Delegated Directive 2015/863/EU, restricts ten substances: lead (Pb), mercury (Hg), hexavalent chromium (Cr VI), polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), benzyl butyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) at 0.1 percent by mass per homogeneous material, and cadmium (Cd) at the stricter limit of 0.01 percent. The homogeneous material concept is understood at atomic level: any assembly that cannot be separated mechanically into parts of distinct chemistry.

What does Delegated Directive 2015/863 change on phthalates?

Directive 2015/863/EU adds the four phthalates DEHP, BBP, DBP and DIBP to Annex II. The application date is differentiated by category. Categories 1 through 7 and 10 (large and small household appliances, IT, consumer electronics, lighting, tools, toys, automatic dispensers) are covered from 22 July 2019. Categories 8 and 9 (medical devices, monitoring and control instruments) follow from 22 July 2021, the extra delay reflecting the long qualification cycles in those sectors.

What is the homogeneous material concept and why does it matter?

Annex II defines a homogeneous material as a material of uniform composition throughout, or a material that cannot be mechanically disjointed into different materials by actions such as unscrewing, cutting, crushing, grinding or abrasive processes. The 0.1 percent threshold (or 0.01 percent for cadmium) applies to each homogeneous material taken separately, not to the finished product or component. The solder on an SMD transistor, the coating on a screw, the core of a cable and its insulation each constitute a distinct homogeneous material. Reasoning at component or assembly level systematically underestimates non-compliance risk.

What exemptions are available and how do they work?

The directive distinguishes two sets of exemptions. Annex III lists general exemptions (for example lead in high-temperature solders, mercury in discharge lamps, cadmium in certain electrical contacts). Annex IV is reserved for medical devices and monitoring and control instruments. Each exemption has a maximum duration (seven years as a rule, five for category 11, seven for categories 8 and 9), reviewed periodically by the European Commission on the basis of consortium or industry-association applications. An expired exemption must be anticipated at design stage: loss of an exemption can render a product non-compliant within months.

How is RoHS compliance demonstrated in the CE technical file?

RoHS compliance is assessed under Module A (internal production control), integrated into the CE technical documentation specified in Annex II of Directive 2011/65/EU. Standard IEC 63000:2018 (formerly EN 50581:2012) sets the expected documentation: identification of components likely to contain restricted substances, evaluation of information collected from suppliers (declarations of conformity, material data sheets, test reports), verification strategy by sampling. The EU declaration of conformity referenced in Article 13 cites Directive 2011/65/EU and its amending directives.

Are there RoHS-equivalent regimes outside the European Union?

Yes. China operates its own regime, known as China RoHS (administered by the MIIT), which restricts the six historical substances (Pb, Hg, Cd, Cr VI, PBB, PBDE) without the phthalates added in 2015, and relies on product labelling (orange or green logo depending on status). The United Arab Emirates (ESMA), Saudi Arabia (SASO), Turkey, India (E-Waste Management Rules 2022) and several other jurisdictions have introduced equivalent regimes, sometimes stricter on specific products. The transposition is never automatic: thresholds, covered categories and assessment procedures differ.

What are the most common practical pitfalls?

Three pitfalls recur. The first is applying thresholds at component or finished-product level rather than at homogeneous material level, which masks local exceedances. The second is missing the phthalate transition for medical devices and measuring instruments effective from July 2021, sometimes still absent from legacy BOMs. The third is failure to track Annex III and Annex IV exemption expiry dates, given that the Commission can decide not to renew an exemption with notice shorter than a typical product cycle.

RoHS 2011/65/EU: restricted hazardous substances in EEE

Author Hugues Orgitello Last updated 27 May 2026 ~13 min read

Guide · RoHS

Adopted on 8 June 2011 and published in the Official Journal on 1 July 2011, Directive 2011/65/EU recasts the first-generation Directive 2002/95/EC by restructuring the scope, aligning the regime with the New Legislative Framework, and making CE marking of electrical and electronic equipment conditional on RoHS compliance. Two main delegated directives have since extended the text: Directive 2015/863/EU, which added four phthalates to the list of restricted substances, and Directive 2017/2102/EU, which clarified several provisions on spare parts, second-hand equipment and the secondary market. This guide presents the list of ten restricted substances with their limits, the eleven product categories, the Annex III and Annex IV exemption mechanism, the application of the homogeneous material concept, the IEC 63000 methodology for the technical file, and the RoHS-equivalent regimes outside the European Union.

From RoHS 1 to RoHS 2: why the 2011 recast

Directive 2002/95/EC, the first generation of the RoHS regime, was adopted in parallel with the WEEE Directive 2002/96/EC and inherited its scope. It restricted six substances (Pb, Hg, Cd, Cr VI, PBB, PBDE) across eight categories of equipment. Several weaknesses became apparent quickly.

The first was scope ambiguity. The breakdown into eight categories left whole families of products out of scope (laboratory instrumentation, medical equipment, certain industrial equipment), and the boundary between categories was often contested. Surveillance authorities and manufacturers did not converge on the classification of the same product.

The second was the lack of integration with the New Legislative Framework. RoHS 1 worked through national transposition, without explicit articulation with CE marking, the EU declaration of conformity, and the assessment modules of Decision 768/2008/EC. Proof of compliance rested on heterogeneous national regimes.

The third was the absence of a dynamic revision mechanism. The list of substances was fixed in the base text, with no fast procedure for additions. Scientific and regulatory pressure on new substance families (phthalates, alternative flame retardants) was rising without a legislative tool to respond.

Directive 2011/65/EU (RoHS 2) introduces three structural changes. It integrates the regime into the New Legislative Framework: RoHS compliance explicitly conditions CE marking, and the EU declaration of conformity cites Directive 2011/65/EU alongside the other applicable directives (EMC, Low Voltage, RED). It introduces an open category 11, named "other EEE not covered by categories 1 to 10", which closes the historical scope gaps. It provides a procedure for revising restricted substances by delegated act, faster than amending the base text.

For the relationship between RoHS and generic CE marking, see the CE marking guide and the detail of the CE scope.

The eleven equipment categories (Annex I)

Annex I of Directive 2011/65/EU lists the categories of equipment covered. Category 11, in force since 22 July 2019, captures all EEE not addressed by categories 1 to 10 and closes most historical ambiguities.

Category	Definition	Examples
1	Large household appliances	Refrigerator, washing machine, oven, fixed air conditioner
2	Small household appliances	Vacuum cleaner, kettle, iron, food processor
3	IT and telecommunications equipment	Computer, printer, landline telephone, modem, router
4	Consumer equipment	Television, radio, amplified musical instrument
5	Lighting equipment	Luminaire, LED lamp, ballast, fluorescent bulb
6	Electrical and electronic tools	Drill, saw, hedge trimmer, portable machine
7	Toys, leisure and sports equipment	Electronic toy, console, electric sports equipment
8	Medical devices (active implants, MD, IVD)	Ultrasound scanner, glucometer, infusion pump, MRI
9	Monitoring and control instruments	Oscilloscope, multimeter, industrial controller, connected sensor
10	Automatic dispensers	Vending machine, automatic ticket machine
11	Other EEE not covered above	Any EEE not falling within categories 1 to 10

Category 11 entered into force on 22 July 2019. Before that date, a product not classifiable in categories 1 to 10 was out of scope, leaving interpretation latitude favourable to manufacturers. Since then, the principle is reversed: an EEE is presumed in scope unless an explicit exclusion is demonstrated (defence, vehicles of category M/N/L, certain specific photovoltaic panels, certain large-scale fixed installations). The boundary with category 8 (medical) and category 9 (instrumentation) remains sensitive for hybrid products.

The ten restricted substances and their limits (Annex II)

Annex II of Directive 2011/65/EU, as amended by Delegated Directive 2015/863/EU, sets the list of restricted substances. The threshold is expressed as a percentage by mass of the homogeneous material.

Substance	Primary CAS	Limit (% by mass, homogeneous material)	Applicable from
Lead (Pb)	7439-92-1	0.1%	1 July 2006 (RoHS 1)
Mercury (Hg)	7439-97-6	0.1%	1 July 2006 (RoHS 1)
Cadmium (Cd)	7440-43-9	0.01%	1 July 2006 (RoHS 1)
Hexavalent chromium (Cr VI)	18540-29-9	0.1%	1 July 2006 (RoHS 1)
Polybrominated biphenyls (PBB)	59536-65-1 (decaPBB)	0.1%	1 July 2006 (RoHS 1)
Polybrominated diphenyl ethers (PBDE)	1163-19-5 (decaBDE)	0.1%	1 July 2006 (RoHS 1)
Bis(2-ethylhexyl) phthalate (DEHP)	117-81-7	0.1%	22 July 2019 (cat. 1-7, 10) / 22 July 2021 (cat. 8, 9)
Benzyl butyl phthalate (BBP)	85-68-7	0.1%	22 July 2019 (cat. 1-7, 10) / 22 July 2021 (cat. 8, 9)
Dibutyl phthalate (DBP)	84-74-2	0.1%	22 July 2019 (cat. 1-7, 10) / 22 July 2021 (cat. 8, 9)
Diisobutyl phthalate (DIBP)	84-69-5	0.1%	22 July 2019 (cat. 1-7, 10) / 22 July 2021 (cat. 8, 9)

Cadmium is the only substance whose threshold is ten times stricter (0.01% instead of 0.1%), reflecting its toxicological profile. Hexavalent chromium targets specifically the +VI oxidation state; trivalent chromium (Cr III), found for example in modern passivation finishes, is not restricted. This distinction is critical for qualifying anti-corrosion surface treatments.

The four phthalates added by Directive 2015/863/EU belong to the plasticiser family. They were historically used in cable sheaths, flexible enclosures, gaskets, and internal wire coatings. The transition to substitute plasticisers (DINP, DIDP, bio-based plasticisers) was already well underway on the consumer side; it extended to medical devices and measuring instruments from 22 July 2021, with the extra delay accommodating the lengthy regulatory qualification cycles in those sectors.

The homogeneous material concept

Annex II defines a homogeneous material as a material of uniform composition throughout, or a material that cannot be mechanically disjointed into different materials by actions such as unscrewing, cutting, crushing, grinding or abrasive processes. The threshold applies to each homogeneous material taken separately, not to the component or finished product.

In practice, a typical electronic component decomposes into several dozen homogeneous materials: the tin alloy of the solder, the base metal of the lead, the nickel plating, the gold plating, the encapsulation epoxy, the silicon of the die, the bonding wires, the laser or screen-printed marking, and so on. Each must satisfy the RoHS threshold independently of the others. Reasoning at component or assembly level by weighted average is non-compliant with Annex II.

For a cable, at minimum the following are distinct: the conductor core, the insulation, the braided shield, the outer jacket, the marking. For a treated screw: the steel body, the zinc plating, the passivation, the topcoat. Each layer separable mechanically is a distinct homogeneous material.

This granularity explains why RoHS compliance cannot be demonstrated by a single global chemical test on the finished product: a global test dilutes local concentrations and masks exceedances. Proof of compliance proceeds through upstream documentation (supplier declarations per material or per qualified component) and targeted testing on at-risk materials (solder alloys, pigmented plastics, surface treatments, insulation sheaths).

Exemptions: Annex III and Annex IV

The European legislator anticipated that, in 2011, some technical applications had no viable alternative to the restricted substances. The directive therefore provides an exemption mechanism, structured in two annexes.

Annex III: general exemptions

Annex III lists exemptions applicable to all categories. It covers narrowly delimited technical situations where substitution is not feasible in the short term or would generate higher health or environmental risks. A few emblematic families:

Lead in high-temperature solders (melting point above 85% of the lead-free reflow window), used in certain aerospace or military assemblies under national contracts.
Lead in the glass of cathode-ray tubes, fluorescent screens, and certain electronic components.
Mercury in fluorescent and vapour discharge lamps (quantity limits per lamp).
Cadmium in the electrical contacts of circuit breakers and power relays for critical applications.
Lead as an alloying element in machining steel, aluminium and copper, within low concentration limits.

Each exemption is identified by a number (for example 6(c) for lead as an alloying element in copper), a technical description, a content limit where applicable, and an expiry date. The maximum duration is seven years as a rule, reduced to five years for category 11 and seven years for categories 8 and 9.

Annex IV: medical and instrumentation exemptions

Annex IV is reserved for medical devices (category 8) and monitoring and control instruments (category 9). It compiles exemptions specific to these sectors, whose regulatory qualification cycles (MDR, IVDR, metrological standards) impose longer substitution timelines.

A few examples: lead in microchannel electron multipliers in spectrometry instruments, mercury in pressure sensors for specific industrial applications, cadmium in certain photovoltaic components of analytical instruments.

Renewal procedure

Every exemption is reviewed periodically by the European Commission, based on applications filed by industry associations or industrial consortia. The review follows its own regulatory schedule, but in practice the process lasts between twelve and twenty-four months from filing to publication of the renewing or withdrawing delegated act.

An exemption not renewed lapses on its expiry date. The product that depended on it then becomes non-compliant if it continues to use the substance concerned. For an industrial operator, tracking expiry dates and active monitoring of ongoing reviews are essential: loss of a critical exemption can force a BOM redesign within months, with supply-chain disruption risk.

Technical documentation and IEC 63000

The directive sets out, in its Annex II, the documentary obligations associated with the demonstration of compliance. The applicable assessment module is Module A (internal production control) of Decision 768/2008/EC: self-declaration without notified-body intervention, but with a complete technical file kept for ten years and made available to surveillance authorities.

The IEC 63000:2018 standard (which superseded EN 50581:2012 at European level) sets out the expected structure and content of this documentation. It organises the demonstration in three layers.

The first layer is the identification of at-risk components and materials. For each item in the BOM, the manufacturer assesses the likelihood of containing a restricted substance. This assessment relies on engineering knowledge (for example, traditional solder alloys contain lead, flexible PVC sheaths may contain phthalates, some anti-corrosion treatments use Cr VI).

The second layer is collection of information from suppliers. Three sources are admissible:

Material Declaration or supplier RoHS declaration of conformity, indicating the restricted substances present and their content per homogeneous material. The usual format is IPC-1752A for electronics, or a contractually equivalent format.
Safety Data Sheet (SDS) for the chemical substances entering the composition.
Analytical test report in case of doubt or absence of supplier data.

The third layer is the verification strategy by sampling. The standard provides that the manufacturer is not required to test every material of every component: a sampling plan proportionate to risk is established, based on material criticality, supplier history, and confidence level of the declarations. Analytical techniques commonly used are X-ray fluorescence spectrometry (XRF) for rapid screening, and mass spectrometry (ICP-MS) or chromatography (GC-MS) for quantitative analysis.

XRF screening detects heavy metals (Pb, Hg, Cd, Cr, Br as a proxy for PBB and PBDE) with a typical sensitivity of a few hundred ppm and a measurement time of seconds per spot. It is well suited to a first pass on a finished product or a series of components, but it does not distinguish Cr VI from Cr III, and it does not detect phthalates. For Cr VI speciation, a wet chemistry test according to IEC 62321-7 is required. For phthalates, GC-MS or pyrolyser-GC-MS after solvent extraction per IEC 62321-8 is the reference method. A consistent sampling strategy combines XRF for rapid coverage, targeted wet chemistry for Cr VI on suspect surface treatments, and GC-MS on flexible plastic parts where phthalates are plausible.

For the relationship between the RoHS technical file and the CE technical file, see the CE technical file guide. The EU declaration of conformity generated according to the Annex VI template of Directive 2011/65/EU is generally consolidated with the declarations of the other applicable directives (RED, EMC, Low Voltage) into a single document. AESTECHNO does not perform chemical lab analysis; this work is subcontracted to an ISO/IEC 17025 accredited laboratory (Eurofins, SGS, Bureau Veritas, Intertek, TUV, and others).

Conformity assessment and CE marking

RoHS compliance follows Module A: self-declaration by the manufacturer, without a notified body. The CE marking affixed to the product attests compliance with all applicable directives, including Directive 2011/65/EU. The EU declaration of conformity explicitly cites the reference 2011/65/EU and the amending directives 2015/863/EU and 2017/2102/EU.

For spare parts, Directive 2017/2102/EU introduced specific provisions. A spare part intended for repair, reuse, functionality update or capability upgrade of an EEE placed on the market before Directive 2011/65/EU entered into force may benefit from a continuity clause: it is admissible even if it does not comply with RoHS 2, provided it is equivalent to the original part. This clause aims to avoid forcing the scrapping of long-life industrial and medical equipment for lack of compliant replacement parts.

Market surveillance relies on Regulation (EU) 2019/1020 and on national authorities (in France, the DGCCRF). Confirmed non-compliances are notified to the RAPEX system (renamed Safety Gate since 2021) when they present a risk to health or the environment. Sanctions, set by each Member State, include administrative fines, market withdrawal, recall from end users, and publication of decisions.

For the RoHS application schedule cross-referenced with other regimes (REACH, EU Battery, CRA, ESPR), see the certification timeline guide. The broader chemical substances regime is addressed in the REACH and SVHC substances guide (companion page in preparation).

RoHS-equivalent regimes outside the European Union

Several jurisdictions have introduced regimes inspired by the European directive, with notable variants on thresholds, covered categories and procedural obligations. The transposition of a CE/RoHS file to these regimes is not automatic.

Jurisdiction	Text	Substances covered	Particularities
China	China RoHS 2 (MIIT, 2016)	The six of RoHS 1 (Pb, Hg, Cd, Cr VI, PBB, PBDE), not the 2015 phthalates	Orange logo (EFUP, Environment-Friendly Use Period) or green; self-declaration with mandatory content table
United Arab Emirates	ESMA RoHS UAE regulation	Aligned with EU RoHS 2	ESMA registration and ECAS marking required
Saudi Arabia	SASO IEC 62321	Aligned with EU RoHS 2	Compliance verified via SABER, SCoC certificate
Turkey	AEEE Yonetmeligi (2012, updated 2019)	Aligned with EU RoHS 2	Near-identical transposition of the EU text, surveillance by Turkish authority
India	E-Waste Management Rules 2022	Aligned with the six of RoHS 1 plus 2015 phthalates	CPCB registration, EPR (Extended Producer Responsibility) register
United Kingdom	UK RoHS Regulations 2012 (post-Brexit)	Aligned with 2011/65/EU and amendments	UKCA marking since 2021, partial return to CE marking accepted

Several other jurisdictions (Korea, Japan via the Act on the Promotion of Recycling, Vietnam, Singapore) operate labelling or hazardous-substance declaration regimes without copying EU RoHS strictly. A multi-market compliance matrix is generally established for products with a global reach.

For the general context of regional regimes and CE/FCC duality, see the CE vs FCC for EMC guide which details the geographic regime split. The spilma glossary groups the key terms (homogeneous material, Annex III exemption, IEC 63000, RAPEX, Safety Gate) with their reference definitions.

Watch-out points

Risk	Consequence	Action
Applying thresholds at component or finished-product level	Systematic underestimation of risk, masked non-compliance	Decompose the BOM by homogeneous material, request supplier declarations at the right granularity
Missing the phthalate transition for categories 8 and 9 from July 2021	Non-compliant medical devices and measuring instruments	Re-audit legacy BOMs, requalify sheaths, gaskets, soft plastics
Confusion between Cr VI and Cr III	Rejection of compliant Cr III passivations, or wrongful acceptance of Cr VI	Require oxidation-state specification from suppliers, attach XRF speciation reports if needed
Insufficient tracking of Annex III and IV exemptions	Unanticipated exemption loss, emergency BOM redesign	Maintain a register of exemptions in use, monitor the review schedule
Partial IEC 63000 technical file	Documentary gap during inspection, market suspension	Structure the documentation along the three layers: identification, supplier collection, sampling
Non-EU transposition without review	Refusal of China, ESMA, SABER registration	Map the CE/RoHS file to the specific requirements of each target regime

For industrial operators exporting in parallel to the EU, China and India, the marginal effort of aligning on the exhaustive list (six historical substances plus four phthalates) is generally preferable to maintaining several regional BOM versions.