RoHS Directive 2011/65/EU

Last reviewed: October 2026 · Sources listed at the end of this page.

Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment — the "RoHS Directive" or RoHS 2 — replaced Directive 2002/95/EC. It restricts ten substances in electrical and electronic equipment (EEE) above maximum concentration values and requires CE marking. Commission Delegated Directives regularly change the lists of exemptions in Annexes III and IV. Published as OJ L 174, 1.7.2011, p. 88.

Legal status and timeline

• Adoption: 8 June 2011.
• Transposition deadline: 2 January 2013 (Article 25). Directive 2002/95/EC was repealed with effect from 3 January 2013 (Article 26).
• Extended product dates (Article 4(3)): medical devices and monitoring and control instruments from 22 July 2014; in vitro diagnostic medical devices from 22 July 2016; industrial monitoring and control instruments from 22 July 2017; all other EEE newly in scope from 22 July 2019.
• Phthalates (DEHP, BBP, DBP, DIBP) added by Delegated Directive (EU) 2015/863: apply from 22 July 2019, and from 22 July 2021 for medical devices and monitoring and control instruments.
• Lead exemption restructuring: Delegated Directives (EU) 2025/1802, 2025/2363 and 2025/2364, reflected in the consolidated text of 1 July 2026.
• Status in October 2026: applies; no replacement act. Directive (EU) 2025/2456 amends it with effect from 13 August 2027.

Scope: products covered

EEE is equipment that depends on electric currents or electromagnetic fields to fulfil at least one intended function, or that generates, transfers or measures them, designed for use at up to 1000 V AC or 1500 V DC (Article 3). Article 2 applies the Directive to EEE in the eleven categories of Annex I:

1. Large household appliances;
2. Small household appliances;
3. IT and telecommunications equipment;
4. Consumer equipment;
5. Lighting equipment;
6. Electrical and electronic tools;
7. Toys, leisure and sports equipment;
8. Medical devices;
9. Monitoring and control instruments including industrial monitoring and control instruments;
10. Automatic dispensers;
11. Other EEE not covered by any of the above categories.

Category 11 is an "open scope" category making the Directive applicable to all EEE not specifically excluded. Article 4(1) also covers cables and spare parts for repair, reuse, updating or upgrading. Article 4(4) lifts this for cables and spare parts for older EEE, by reference to the date that EEE was placed on the market: before 1 July 2006 for EEE in scope of the earlier Directive, and later dates for the categories added afterwards.

Exclusions (Article 2(4))

• Equipment necessary for the protection of the essential security interests of Member States, including arms, munitions and war material for specifically military purposes;
• Equipment designed to be sent into space;
• Equipment specifically designed and installed as part of another type of equipment that is excluded or out of scope, which can fulfil its function only as part of that equipment and can be replaced only by the same specifically designed equipment;
• Large-scale stationary industrial tools;
• Large-scale fixed installations;
• Means of transport for persons or goods, excluding electric two-wheel vehicles which are not type-approved;
• Non-road mobile machinery made available exclusively for professional use;
• Active implantable medical devices;
• Photovoltaic panels for a system designed, assembled and installed by professionals for permanent use at a defined location;
• Equipment specifically designed solely for research and development, only made available business to business;
• Pipe organs.

Borderline cases

• Large-scale stationary industrial tools (Article 3(3)). The exclusion needs a large-scale assembly of machines, equipment or components working together, permanently installed and de-installed by professionals, and used and maintained by professionals in an industrial manufacturing or R&D facility. A standalone bench machine does not qualify.
• Large-scale fixed installations (Article 3(4)). The combination must be assembled, installed and de-installed by professionals and intended for permanent use at a dedicated location. Equipment sold separately for installation there is assessed on its own, subject to the third exclusion above.
• Non-road mobile machinery. Consumer-grade versions fall outside the exclusion, since it covers machinery made available exclusively for professional use.
• Non-electrical products with a minor electrical feature. If the product needs electricity for at least one intended function, it is dependent and therefore EEE (Article 3(2)).

Restricted substances (Annex II)

Annex II lists the ten restricted substances and their maximum concentration values (by weight in homogeneous materials):

• Lead (0.1%);
• Mercury (0.1%);
• Cadmium (0.01%);
• Hexavalent chromium (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 threshold applies per homogeneous material: one material of uniform composition throughout, or a combination of materials that cannot be separated by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes. It does not apply at product level. A limit of 0.1% is 1,000 ppm and 0.01% is 100 ppm.

Example. A cable has a PVC sheath of 100 g containing 200 mg of DEHP. That is 0.2% in the sheath, so it fails, even if the DEHP is only 0.05% of a 400 g product. Averaging across the product is not permitted.

The restriction of DEHP, BBP and DBP does not apply to toys already covered by entry 51 of Annex XVII to REACH (Annex II).

Exemptions (Annexes III and IV)

Annex III lists exempted applications generally; Annex IV lists those specific to medical devices and monitoring and control instruments. Exemptions have a validity period of up to 5 years for categories 1 to 7, 10 and 11 and up to 7 years for categories 8 and 9, and may be renewed (Article 5(2)). An exemption applies only to the exact application and limit described.

Lead and cadmium dates in the text of 1 July 2026

Entries 6(a)-I, 6(a)-II, 6(b)-I, 6(b)-II, 6(b)-III and 6(c) carry a footnote excluding EEE supplied to the general public that children may put in their mouths, unless a lead release limit is demonstrated. Conditions in the Annex text take precedence over this summary.

Most general-purpose mercury lamp entries have also expired: entries 1(a) to 1(e) for single-capped fluorescent lamps expired on 24 February 2023. A group of narrower lamp entries, for example 4(e) for metal halide lamps, expires on 24 February 2027.

What an expiry date means

• Check for a pending renewal. An application for renewal must be made at least 18 months before expiry, and the existing exemption remains valid until the Commission decides (Article 5(5)). A printed date can therefore be overtaken. Check the Commission's RoHS pages and the Official Journal.
• Rejection or revocation. The exemption expires at the earliest 12 months and at the latest 18 months after the decision (Article 5(6)).
• Products already on the market. EEE that benefited from an exemption and was placed on the market before it expired is not affected, as far as that exemption is concerned (Article 4(4)(f)). Each later unit placed on the market must meet the rules that apply on that date.
• In the pipeline. In July 2026 the Commission consulted on a draft delegated directive reported to cover Annex III entries including 5(b), 13(a), 18(b), 24(a), 29, 32 and 34, and several Annex IV entries. It had not been found in the Official Journal at this review.

Manufacturers relying on an exemption must record it in the technical documentation and check that it still applies when each batch is placed on the market.

Conformity assessment

Article 7(b) requires the manufacturer to draw up technical documentation and carry out internal production control in line with Module A of Annex II to Decision No 768/2008/EC. No Notified Body is involved. The manufacturer compiles the technical documentation, manufactures in conformity, draws up the EU Declaration of Conformity, and affixes the CE marking. If another act requires a procedure at least as stringent, compliance can be shown within that procedure (Article 7(c)). See conformity assessment modules.

Technical documentation

Article 7(e) requires the manufacturer to ensure that procedures are in place for series production to remain in conformity. EN IEC 63000:2018, cited by Implementing Decision (EU) 2020/659 in place of EN 50581:2012, is the harmonised standard for the technical documentation. Assessment under it supports the presumption in Article 16(2). It covers: assessment of materials, sub-assemblies, components against the restricted substance thresholds; documentation from suppliers (material declarations, test reports); reasoning where suppliers' documentation is treated as sufficient; sampling and analytical testing where suppliers' documentation is insufficient.

Retention: 10 years (Article 7(d)). See technical documentation.

EU Declaration of Conformity

Article 13 and Annex VI set the contents. A single Declaration covering RoHS together with the LVD, EMC Directive, RED, and other applicable acts is the normal approach. See EU Declaration of Conformity.

Marking and labelling

Article 7(c) requires the manufacturer to affix the CE marking on the finished product. RoHS requires no additional symbol. EEE bearing the CE marking is presumed to comply unless there is evidence to the contrary (Article 16(1)). See affixing the CE mark.

Recent and upcoming changes

• Exemptions. Delegated Directives (EU) 2025/1802, 2025/2363 and 2025/2364 of 8 September 2025 restructured lead exemptions 7(a), 7(c) and 6(a) to 6(c). A further draft was consulted on in July and August 2026.
• Commission review. The Commission's page records that its review was finalised on 7 December 2023, with a targeted amendment proposed. That amendment became Directive (EU) 2025/2456.
• ECHA tasks. Directive (EU) 2025/2456 reattributes scientific and technical tasks to the European Chemicals Agency and applies from 13 August 2027. It also provides for the Commission to consider a review of the Annex II list at least every four years.
• Annex II. The list remains at ten substances. No new substance has been added since the four phthalates.

Related legislation

• REACH Regulation (EC) 1907/2006 — applies in parallel for chemical substances; RoHS restrictions are distinct from REACH Annex XVII restrictions and SVHC notifications.
• WEEE Directive 2012/19/EU — addresses end-of-life management of EEE; structurally linked to RoHS through the same EEE categories.
• Low Voltage Directive 2014/35/EU, EMC Directive 2014/30/EU, Radio Equipment Directive 2014/53/EU — apply in parallel.
• Battery Regulation 2023/1542 — applies to batteries integrated in EEE.
• Ecodesign Regulation 2024/1781 — applies in parallel for energy-related performance.

Common errors

• Assessing at product level rather than homogeneous material level. The threshold concentrations apply per homogeneous material; an overall product-level percentage masks compliant and non-compliant materials.
• Reliance on supplier statements without verification. EN IEC 63000 requires reasoned evaluation of supplier documentation. Generic "RoHS compliant" statements from suppliers without specifying which Annex III exemptions are relied on are insufficient.
• Expired or narrowed exemptions. Annex III exemptions have validity dates and are often split into narrower entries. Reliance on an expired one is non-compliance regardless of good faith. Re-check the entry, not just the number: 6(a), for example, now has separate successors with different limits.
• Forgetting medical devices and monitoring instruments. Categories 8 and 9 are in scope; medical device manufacturers sometimes treat RoHS as inapplicable.
• Forgetting cables and spare parts. Article 4(1) covers them, subject to the exceptions for older EEE in Article 4(4).

Frequently asked questions

Which substances does RoHS restrict?

Lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP and DIBP at 0.1%, and cadmium at 0.01%, by weight in homogeneous materials (Annex II).

Does RoHS need a Notified Body?

No. The manufacturer uses Module A internal production control, draws up the documentation and the EU Declaration of Conformity, and affixes the CE marking.

What happens when a RoHS exemption expires?

Products placed on the market after expiry can no longer rely on it, unless a renewal application made on time is pending, in which case the exemption stays valid until the Commission decides. EEE placed on the market before expiry is not affected.

Which RoHS exemptions expire on 11 December 2026?

In the text of 1 July 2026, entry 6(a) and entry 6(b)-I for categories 1 to 7 and 10. Successor entries 6(a)-I and 6(a)-II run to 30 June 2027, and 6(b)-I runs to that date for industrial monitoring and control instruments and category 11.

Is RoHS the same as REACH?

No. They apply in parallel. RoHS restricts listed substances in EEE; REACH covers chemicals more widely, including SVHC duties and Annex XVII restrictions. A product can comply with one and not the other.

Sources

• Directive 2011/65/EU (RoHS 2) — OJ text; consolidated text of 1 July 2026.
• European Commission — RoHS Directive (DG ENV).
• Commission Delegated Directives (EU) 2025/1802, 2025/2363 and 2025/2364.
• Directive (EU) 2025/2456 — EUR-Lex.
• Commission Implementing Decision (EU) 2020/659 — EUR-Lex.
• EN IEC 63000:2018 (technical documentation for the assessment of EEE with respect to restriction of hazardous substances).
• Commission Notice — Blue Guide 2022 — EUR-Lex.