Chemicals & Substances 10 min

RoHS - Directive 2011/65/EU

Guide to RoHS - what it restricts, who it applies to, the 10 substances and limits, and how to prove compliance with CE marking.

Official text on EUR-Lex ↗

What RoHS is and why it matters

RoHS is the EU rulebook that keeps a defined set of hazardous substances out of the electrical and electronic equipment you place on the European market. Short for “Restriction of Hazardous Substances”, it is set out in Directive 2011/65/EU (commonly called RoHS 2) and exists for two connected reasons: to protect human health from toxic materials during manufacturing, use and recycling, and to make end-of-life electronics safer and easier to process. Lead in solder, cadmium in coatings or mercury in lamps do not stay locked inside a product forever - they leach into landfill, escape during shredding, and accumulate in workers and the environment. By restricting these substances at the design and sourcing stage, RoHS removes the problem before it is built into millions of devices.

For anyone selling electronics in the EU, RoHS is not optional and it is not a label you can add afterwards. It is a precondition for CE marking. If a product cannot demonstrate RoHS compliance, it cannot legally carry the CE mark, and without the CE mark it cannot be sold. That makes RoHS one of the most fundamental pieces of compliance for the entire electronics supply chain.

Official text The authoritative version of RoHS is published on EUR-Lex. Always rely on it rather than summaries: Directive 2011/65/EU on EUR-Lex (English)

Who and what RoHS applies to

RoHS applies to electrical and electronic equipment (EEE) - broadly, anything that depends on electric currents or electromagnetic fields to do its primary job, plus equipment that generates, transfers or measures those currents and fields, rated for up to 1000 V AC or 1500 V DC.

The directive organises EEE into categories, and RoHS 2 made the scope “open” - covering eleven categories including large and small household appliances, IT and telecommunications equipment, consumer electronics, lighting, electrical and electronic tools, toys and leisure equipment, medical devices, monitoring and control instruments, automatic dispensers, and a catch-all category for any other EEE not covered elsewhere. In practice, if a product needs electricity to function, you should assume RoHS applies unless a specific exclusion (such as certain large-scale fixed installations, certain military equipment, or means of transport beyond two-wheel vehicles) removes it.

The obligations fall on different economic operators:

Crucially, an importer or distributor who sells a product under their own name, or modifies a product already on the market, takes on the full responsibilities of a manufacturer.

The 10 restricted substances and their limits

RoHS originally restricted six substances. Delegated Directive (EU) 2015/863 added four phthalates, bringing the total to ten:

The maximum tolerated concentration is 0.1% by weight for each substance, with the stricter limit of 0.01% by weight for cadmium.

The detail that trips people up is that these limits apply per homogeneous material, not per product or per component. A “homogeneous material” is a material that cannot be mechanically separated into different materials - for example, the plastic housing, a single layer of plating, the solder on a joint, or the insulation on a wire. You cannot dilute a non-compliant solder by pointing to the total mass of the finished device. Each individual material must independently meet the threshold, which is why compliance has to be built and verified at the bill-of-materials level, supplier by supplier.

How RoHS compliance is demonstrated

RoHS is a self-declaration regime - there is no government pre-approval. The manufacturer assesses conformity (the internal production control route) and then stands behind it with documentation:

Exemptions exist where a restricted substance is technically unavoidable or its removal would do more harm than good. These are listed in Annex III (general applications) and Annex IV (medical devices and monitoring/control instruments). Each exemption is time-limited and reviewed periodically, so it can expire or be renewed - relying on one means tracking its validity date, because an expired exemption instantly makes a previously compliant product non-compliant.

Testing typically follows two stages. XRF (X-ray fluorescence) screening gives a fast, non-destructive read on elemental content (lead, cadmium, mercury, total chromium and bromine) and is ideal for triaging incoming materials. Where XRF flags a borderline result, or where speciation matters (hexavalent chromium, specific phthalates, PBB/PBDE), wet-chemistry laboratory analysis to standards such as the IEC 62321 series confirms the actual concentrations.

How RoHS relates to REACH and WEEE

RoHS does not stand alone. It works alongside two other major regimes, and confusing them is a common source of compliance gaps:

See the related guides below for REACH and WEEE, POPs and the Detergents Regulation.

Enforcement and consequences

RoHS is enforced through national market surveillance. In Denmark the competent authority is the Sikkerhedsstyrelsen (Danish Safety Technology Authority), which can request technical documentation, sample and test products on the market, and act against non-compliant equipment.

The consequences are qualitative but serious: an order to bring the product into conformity, withdrawal or recall from the market, sales bans, and in serious cases fines. Beyond the legal penalties, a RoHS failure usually means the CE marking is invalid, which can cascade into removed product listings, rejected shipments at the border, and loss of customer and retailer trust. Because the obligation runs across the supply chain, a single non-compliant homogeneous material from one supplier can render an entire product line non-compliant.

Getting compliant: a checklist

How Conphora helps

Conphora automatically monitors RoHS and matches your products against the relevant substance restrictions, exemptions and documentation requirements. The platform flags gaps at the bill-of-materials level, generates the declarations you need, and alerts you when an exemption expires or the directive changes - so compliance stays current instead of going stale.

See how Conphora works

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Sources

This guide is for general information and is not legal advice.

Last updated: 12 June 2026

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