Directive 2011/65/EU: RoHS 2 Scope, Substances, and Obligations

The RoHS 2 Directive, formally Directive 2011/65/EU, restricts ten hazardous substances in electrical and electronic equipment sold in the European Union and requires manufacturers to prove compliance through a technical file, an EU Declaration of Conformity, and CE marking on the product.¹ Importers and distributors within the EU carry their own verification duties, and each member state enforces the rules through its own market surveillance authority.

Which Products Fall Under RoHS 2

RoHS 2 applies to any device that depends on electric currents or electromagnetic fields to work, along with the cables and spare parts used to repair or upgrade those devices.¹ The directive uses an “open scope”: everything electrical or electronic is covered unless it is specifically excluded.² Annex I organizes covered products into eleven categories: large and small household appliances, IT and telecommunications equipment, consumer electronics, lighting, electrical and electronic tools, toys, medical devices, monitoring and control instruments, automatic dispensers, and a catch-all for anything else electrical.

What Is Excluded

Several product classes sit outside RoHS entirely:²

Military and national security equipment, including weapons systems
Equipment designed for space, such as satellites and probes
Large-scale fixed installations like lifts and conveyor systems
Large-scale stationary industrial tools, including production lines and cranes
Means of transport: cars, aircraft, trains, and boats
Non-road mobile machinery such as excavators, forklifts, and harvesters
Active implantable medical devices, such as pacemakers
Photovoltaic panels
Research and development equipment supplied strictly business-to-business

Batteries and packaging are also outside RoHS scope because they are governed by their own EU directives.

The Ten Restricted Substances and Their Limits

Annex II of the directive lists ten substances that must not exceed the following maximum concentration values by weight in any homogeneous material:³

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 four phthalates (DEHP, BBP, DBP, DIBP) were added by the 2015/863 amendment; the other six have been restricted since the directive took effect.⁴ Cadmium has a limit ten times stricter than the others.

What “Homogeneous Material” Means

The thresholds apply per homogeneous material, not to the finished product as a whole. A homogeneous material is one that cannot be mechanically separated into distinct materials: a single layer of coating, a solder joint, the plastic housing of a connector. Every such material inside a finished product must independently stay within the limit. A device that averages under 0.1% lead across all its parts can still fail RoHS if one solder joint exceeds the threshold.

Exemptions From the Substance Restrictions

Some uses of a restricted substance are permitted because no workable substitute exists. Annex III lists general exemptions across product categories, and Annex IV holds exemptions reserved for medical devices and monitoring instruments. An exemption may be granted when eliminating the substance is technically impracticable, when no reliable substitute exists, or when the environmental and health costs of switching would outweigh the benefits.⁵ Common examples include lead in certain steel, aluminum, and copper alloys for machining, and lead in specific solders, glass, and ceramic applications.

Exemptions expire. For most product categories (1 through 7, 10, and 11) an exemption lasts up to five years; for medical devices and monitoring instruments (categories 8 and 9) it lasts up to seven years.⁵ A renewal application must be submitted at least 18 months before the exemption expires, and the Commission must decide at least 6 months before the expiry date. If an exemption is rejected or revoked, manufacturers get a transition period of 12 to 18 months before it actually ends.

What Manufacturers Have to Do

Before placing a product on the EU market, a manufacturer must compile a technical file demonstrating that the product meets the substance restrictions. The file describes the equipment, includes design drawings and manufacturing details, lists materials and components, and gathers supporting evidence such as test reports or supplier declarations showing compliance at the homogeneous-material level.

The harmonized standard for assembling this documentation is EN IEC 63000:2018, which replaced EN 50581:2012. Since June 2024, EN IEC 63000 is the only accepted standard for demonstrating RoHS compliance through documentation. It permits a tiered approach: supplier declarations, contractual agreements, industry-standard material declarations, and analytical testing where necessary. Reliable supplier data can reduce, though not always replace, lab testing.

Once the technical file is complete, the manufacturer drafts an EU Declaration of Conformity. Annex VI specifies its contents:⁶

A unique product identification number
The manufacturer’s name and address, or that of an authorized representative
A statement that the declaration is issued under the manufacturer’s sole responsibility
Identification of the equipment, including a photograph where appropriate
A statement confirming conformity with Directive 2011/65/EU
References to any harmonized standards used
Signature, date, and place of issue

The CE mark is then affixed to the finished product or its data plate. It must be visible, legible, and permanent, and since January 2, 2013, it is the sole marking that demonstrates a product meets RoHS requirements.² After placing the product on the market, the manufacturer must keep the technical file and the Declaration of Conformity available for ten years from the date the last unit was first placed on the market.⁷ Market surveillance authorities can request those records at any time during that window.

Duties for Importers and Distributors

Manufacturers outside the EU do not deal directly with EU authorities. Importers and distributors inside the supply chain carry that role, and each has a distinct set of duties.

Importers

Before placing equipment on the EU market, an importer must verify that the manufacturer has carried out the proper conformity assessment, prepared the technical documentation, and applied the CE marking.⁸ The importer must also place their own name, trade name, and contact address on the product, or on the packaging if the product is too small. If an importer suspects a product does not comply, they cannot place it on the market until the problem is resolved, and they must notify the manufacturer and the relevant surveillance authorities.

Importers keep a register of non-compliant products and recalls, keep distributors informed of compliance issues, and retain a copy of the EU Declaration of Conformity for ten years.⁸ When a product already on the market is found non-compliant, the importer must take immediate corrective action, whether that means bringing the product into conformity, withdrawing it, or issuing a recall, and inform the national authorities of the affected member states.

Distributors

Before making equipment available on the market, a distributor must confirm that the product bears the CE marking and is accompanied by the required documentation in a language consumers in that member state can understand.⁹ A distributor who has reason to believe a product is non-compliant must stop selling it, notify the manufacturer or importer, and inform surveillance authorities. Distributors also cooperate with authorities and produce documentation on request.

Authorized Representatives

A non-EU manufacturer may appoint an authorized representative established within the EU. Under Regulation (EU) 2019/1020 on market surveillance, this representative liaises with national authorities and is responsible for confirming that the technical file and Declaration of Conformity exist and are maintained. Appointing a representative does not relieve the manufacturer of their own obligations; it simply gives authorities a local point of contact.

Enforcement and Penalties

Each EU member state operates its own market surveillance authority. These authorities can inspect premises, test products, and take enforcement action against non-compliant goods. Typical measures include mandatory withdrawal from the distribution chain and, in more serious cases, recall from end users.

Article 23 of the directive requires member states to set their own penalty rules, so the financial consequences vary.¹⁰ Germany allows fines of up to €30,000 and imprisonment of up to one year for importers of non-compliant products. Denmark sets no maximum fine and permits imprisonment of up to two years depending on the severity. For most companies, the reputational damage and lost sales from a forced withdrawal or recall run higher than the fine itself.

National authorities can also invoke the broader EU Market Surveillance Regulation (2019/1020), which grants powers to enter premises, impose penalties, and take corrective measures at the expense of an economic operator that fails to act. Products sold online face the same enforcement regime as products sold through physical retail.

1
EUR-Lex. Directive 2011/65/EU of the European Parliament and of the Council
2
European Commission. RoHS 2 FAQ Guidance Document
3
EUR-Lex. Directive 2011/65/EU – Annex II
4
European Commission. Restriction of Hazardous Substances in Electrical and Electronic Equipment
5
EUR-Lex. Directive 2011/65/EU – Article 5
6
EUR-Lex. Directive 2011/65/EU – Annex VI
7
GOV.UK. Regulations: Restriction of Hazardous Substances
8
UK Legislation. Directive 2011/65/EU – Article 9
9
UK Legislation. Directive 2011/65/EU – Article 10
10
EUR-Lex. Directive 2011/65/EU – Article 23