RoHS Directive 2011/65/EU

Last reviewed: May 2026 · Legal status verified against EUR-Lex.

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 and has applied since 2 January 2013. It restricts ten substances in electrical and electronic equipment (EEE) at threshold concentrations and requires CE marking attesting to conformity. The Directive is repeatedly amended through Commission Delegated Directives that adjust the list 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.
• Date of application: 2 January 2013.
• Phthalates (DEHP, BBP, DBP, DIBP) added to restricted substances: applied from 22 July 2019 (and 22 July 2021 for medical devices and monitoring instruments).
• Status in May 2026: applies. The Commission's RoHS 3 review is in preparation but no replacement act has been adopted.

Scope: products covered

Article 2 applies to EEE falling within the eleven categories listed in 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. Cables, spare parts, and components for repair are within scope where they are EEE.

Exclusions (Article 2(4))

• Equipment necessary for the protection of essential security interests, weapons, munitions, military material;
• Equipment designed for sending to space;
• Equipment specifically designed and to be installed as part of equipment that is excluded;
• Large-scale stationary industrial tools;
• Large-scale fixed installations;
• Means of transport for persons or goods (other than electric two-wheel vehicles not type-approved);
• Non-road mobile machinery for professional use only;
• Active implantable medical devices (until further notice);
• Photovoltaic panels intended to be used in a system designed and assembled by professionals.

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 — defined as a material that cannot be mechanically disjointed into different materials. The threshold is not at the product level. A 0.1% threshold permits up to 1,000 ppm.

Exemptions (Annexes III and IV)

Annex III lists exemptions applicable to all categories of EEE. Annex IV lists exemptions specific to medical devices and monitoring and control instruments. Each exemption has a validity date (typically 5 to 7 years) after which it must be re-evaluated. The Commission adopts Delegated Directives extending, modifying, or removing exemptions. Notable examples:

• Lead in solder used in certain electronic components — multiple Annex III entries with category-specific validity;
• Cadmium in colour-converting LEDs — exempt for specific applications under Annex III Entry 39;
• Mercury in single-capped fluorescent lamps — exemption progressively narrowed since 2017.

Manufacturers relying on an exemption must document its application in the technical file and verify that the exemption remains in force at the time of placing each batch on the market.

Conformity assessment

Article 7(b) requires the manufacturer to carry out the internal production control procedure set out in Module A of Annex II of Decision No 768/2008/EC — i.e., self-declaration. 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. See conformity assessment modules.

Technical documentation

Article 7(c) requires the manufacturer to ensure that procedures are in place for series production to remain in conformity. EN IEC 63000:2018 (previously EN 50581) is the harmonised standard for technical documentation supporting compliance with RoHS. It specifies the content of the file: 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(c)). See technical documentation.

EU Declaration of Conformity

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

Marking and labelling

Article 7(g) requires the manufacturer to affix the CE marking. No additional symbol is required by RoHS; the CE mark itself indicates conformity with RoHS along with other applicable acts. See affixing the CE mark.

Recent and upcoming changes

• Commission Delegated Directives continually adjust Annex III and Annex IV exemptions. Major reviews of long-standing exemptions occurred in 2024–2025.
• The Commission's RoHS review (ongoing) is considering: revision of scope (especially Category 11); review of the restriction list and possible additions; alignment with REACH SVHC processes; consideration of bisphenol A and chlorinated paraffins.
• The interplay with the Battery Regulation 2023/1542, the Ecodesign Regulation 2024/1781, and the WEEE Directive 2012/19/EU is under active review.

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 exemptions. Annex III exemptions have validity dates. Continued reliance on an expired exemption is non-compliance regardless of the manufacturer's good-faith belief.
• Forgetting medical devices and monitoring instruments. Categories 8 and 9 are in scope; medical device manufacturers sometimes treat RoHS as inapplicable.
• Excluding cables, spare parts, and accessories. These are EEE in scope of the Directive where placed on the market separately as products.

Sources

• Directive 2011/65/EU (RoHS 2) — EUR-Lex consolidated text.
• European Commission — RoHS Directive (DG ENV).
• Commission Delegated Directives amending Annex III and Annex IV — published in the OJEU periodically.
• 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.