RoHS Compliance: A Practical Guide for Manufacturers

RoHS (Restriction of Hazardous Substances) is the EU law that restricts ten hazardous substances in electrical and electronic equipment (EEE) placed on the EU market. The current legal text is Directive 2011/65/EU, often called RoHS 2, as amended by Delegated Directive (EU) 2015/863, which added four phthalates and is sometimes called RoHS 3. Compliance is mandatory for manufacturers, importers, and distributors of in-scope products, and it sits inside the CE marking conformity assessment rather than alongside it.

The substance list itself has not been expanded since 2015, but lead exemptions, category-specific deadlines, and the overlap with REACH continue to evolve. RoHS is best treated as a living obligation, not a one-time check.

RoHS is the Restriction of Hazardous Substances Directive, an EU law that limits the use of ten specific hazardous substances in electrical and electronic equipment sold in the EU. Its purpose is to reduce the environmental and health impact of EEE, particularly when products reach end of life and become waste.

The directive has gone through three iterations:

• RoHS 1: Directive 2002/95/EC, the original 2003 directive that restricted six substances
• RoHS 2: Directive 2011/65/EU, the 2011 recast that expanded scope and integrated RoHS into the CE marking framework
• RoHS 3: Delegated Directive (EU) 2015/863, which added four phthalates to Annex II of RoHS 2

When people today say "the RoHS Directive" or "RoHS compliant," they almost always mean Directive 2011/65/EU as amended. RoHS 2 is the legal instrument; RoHS 3 is an amendment to its substance list, not a separate directive.

Who enforces RoHS?

RoHS is implemented and enforced at Member State level. Each EU country designates national market surveillance authorities that can request technical documentation, test products, and impose corrective measures. The European Commission oversees the directive itself, including the Annex III and Annex IV exemptions process that decides which substance-application pairs are technically impractical to substitute today.

The RoHS Directive restricts the following ten substances at the homogeneous material level. The maximum concentration values (MCVs) are set out in Annex II of Directive 2011/65/EU as amended by 2015/863.

A few details that matter in practice:

• Homogeneous material is the testing unit, not the product. A homogeneous material is one that cannot be mechanically disjointed into different materials, for example a single polymer layer or a single solder joint. A product that is RoHS-compliant overall can still fail testing if any one homogeneous material exceeds its MCV.
• The four phthalates (DEHP, BBP, DBP, DIBP) were added by Delegated Directive (EU) 2015/863 and applied to most EEE from 22 July 2019. For Category 8 (medical devices) and Category 9 (monitoring and control instruments), application was extended to 22 July 2021.
• Exemptions exist for specific applications where substitution is technically impractical. They are listed in Annex III (general exemptions) and Annex IV (medical and monitoring exemptions) of Directive 2011/65/EU. Each exemption has its own expiry date and renewal cycle.

RoHS applies to all electrical and electronic equipment placed on the EU market, with limited exclusions for military equipment, equipment designed for use in space, large-scale stationary industrial tools, large-scale fixed installations, and certain transport equipment, as set out in Article 2(4) of the directive.

Since 22 July 2019, RoHS has operated under "open scope": Category 11 ("Other EEE not covered by any of the categories above") was added, and any EEE not explicitly excluded is in scope. The eleven categories listed in Annex I are:

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)
10. Automatic dispensers
11. Other EEE not covered by any of the categories above

The categories are functional rather than enumerated: there is no fixed list of products that fall under "small household appliances," for example. Manufacturers determine which category applies based on the product's intended function.

The directive distinguishes three economic operators, each with a defined set of obligations:

• Manufacturers (Article 7): companies that design or manufacture EEE under their own name or trademark. They must ensure compliance, draw up technical documentation, complete the internal production control procedure, draw up the EU Declaration of Conformity, and affix the CE marking.
• Importers (Article 9): companies that place EEE from outside the EU on the EU market. Importers must verify that the manufacturer has met its obligations, that the technical documentation exists, that the DoC has been drawn up, and that the CE marking is affixed. They must also indicate their own name and contact address on the product or its packaging.
• Distributors (Article 10): companies that make EEE available on the market without altering it. Distributors must verify that the CE marking is affixed and that the product is accompanied by the required documents before placing it on the market.

There is one important catch. Article 11 of Directive 2011/65/EU ("Cases in which obligations of manufacturers apply to importers and distributors") provides that an importer or distributor "is considered a manufacturer for the purposes of this Directive" and is subject to the manufacturer obligations under Article 7 where it places EEE on the market under its own name or trademark, or modifies EEE already on the market in a way that may affect compliance. This is the rule that catches many private-label retailers off guard.

Does RoHS apply to imported products?

Yes. Importers placing EEE from outside the EU on the EU market must verify that the product meets RoHS requirements, that the manufacturer has prepared the technical documentation, and that the CE mark is affixed. If an importer places the product under its own name or trademark, or modifies it in a way that affects compliance, the importer is treated as a manufacturer under Article 11 and takes on the full manufacturer obligations of Article 7.

If you sell EEE in the EU, RoHS compliance is part of the CE marking conformity assessment, not a separate exercise. Article 7(b) of Directive 2011/65/EU requires manufacturers to carry out the internal production control procedure set out in Module A of Annex II to Decision No 768/2008/EC, the standard self-declaration procedure used across most CE-marking directives.

In practice this means:

1. You compile the technical documentation that demonstrates RoHS compliance.
2. You draw up an EU Declaration of Conformity covering RoHS and any other applicable directives (EMC, Low Voltage, Radio Equipment, and so on).
3. You affix the CE mark to the product.
4. You retain the documentation for ten years after the product is last placed on the market.

The CE mark on an in-scope EEE product implicitly declares RoHS compliance. There is no separate "RoHS mark" required by EU law. A product cannot be CE-marked if it falls within RoHS scope and fails to meet RoHS substance limits.

Is RoHS certification mandatory?

RoHS compliance is mandatory for in-scope EEE sold in the EU, but there is no government-issued RoHS certificate. Compliance is self-declared by the manufacturer through technical documentation and the EU Declaration of Conformity. What people commonly call a "RoHS certificate" is a self-declaration document, typically issued at the supplier or manufacturer level. The legal instrument of conformity under EU law is the EU Declaration of Conformity drawn up per Annex VI of Directive 2011/65/EU.

There is no government-issued "RoHS certificate." RoHS is a self-declaration regime: you certify your own product based on a documented assessment, and you retain that documentation in case a market surveillance authority asks for it.

Three documents matter.

1. The technical file (per EN IEC 63000:2018)

EN IEC 63000:2018 is the current harmonised standard for RoHS technical documentation. It replaced EN 50581:2012, which was withdrawn. Following EN IEC 63000:2018 gives you a presumption of conformity with the documentation requirements of the directive.

A RoHS technical file typically contains a general description of the product, a bill of materials at homogeneous-material granularity, and supporting evidence for each material: supplier declarations, full material declarations, test reports, or analytical data. It also documents the product's overall conformity assessment and the rationale linking the evidence to that conclusion.

2. The EU Declaration of Conformity (per Annex VI)

Annex VI of Directive 2011/65/EU sets out the required content of the EU DoC for RoHS. It includes the manufacturer's identification, the product identification, a statement that the product conforms to the directive, references to the harmonised standards used, and the place and date of issue with the signature of the responsible person.

The DoC for RoHS is usually combined with the DoC for the other directives the product complies with, producing a single combined EU DoC for the CE marking. This is permitted and is generally recommended over separate per-directive declarations.

3. Supplier evidence

You can only declare what your suppliers can prove. Most manufacturers collect a combination of supplier RoHS declarations, full material disclosures (often in IPC-1752A or IEC 62474 format), and analytical test reports for higher-risk components. Whatever you collect, the evidence has to be specific enough that an auditor can trace any homogeneous material in the product back to a supporting document.

A common confusion point: when buyers ask suppliers for a "RoHS CoC" or "RoHS certificate," what they're usually asking for is a supplier declaration of RoHS conformity, not a third-party certificate. The terminology is sloppy across the industry, but the underlying document is a written statement from the supplier that their part meets the RoHS substance limits.

How long must I keep RoHS documentation?

Manufacturers and importers must keep the technical documentation and EU Declaration of Conformity for ten years after the product was last placed on the EU market. The same retention rule applies to the supporting supplier evidence cited in the technical file. National market surveillance authorities can demand the file during that window and expect it to be made available promptly in a language the authority can understand.

RoHS and REACH are often confused because both restrict hazardous substances in products sold in the EU. They are different laws with different scopes.

RoHS restricts ten specific substances in electrical and electronic equipment, at the homogeneous material level, with hard concentration limits. Scope is narrow (EEE only); the restrictions are absolute, subject to specific exemptions.

REACH (Regulation (EC) No 1907/2006) covers chemical substances generally. It works through a different set of mechanisms: registration of substances manufactured or imported above one tonne per year per company, communication of substances of very high concern (SVHCs) in articles, SCIP notification, and restrictions and authorisations on specific uses. REACH applies to almost any product sold in the EU, not just EEE.

In practice, an EEE manufacturer typically has to comply with both. RoHS sets a hard ceiling on the ten restricted substances in your EEE; REACH adds obligations around SVHC communication, SCIP database submission, and substance restrictions under Annex XVII. The two regimes overlap on substances like lead and certain phthalates but use different thresholds, scope rules, and reporting mechanisms.

For a single SKU, RoHS is manageable on a spreadsheet. For hundreds of SKUs across dozens of markets, it isn't. The work that breaks teams isn't the first compliance assessment; it's keeping every SKU's documentation current as suppliers change, materials change, exemptions expire, and you launch into new markets. For a sense of what compliance at retail scale looks like, see how Flying Tiger Copenhagen handles compliance across 500 new products a month and 44 markets.

A repeatable RoHS process tends to follow five steps.

This last step is where compliance most often fails, not because teams don't care, but because the manual workload makes continuous monitoring impossible. The fix is to structure the underlying product data well enough that re-assessment is automatic when something changes.

RoHS is one of the more stable regulatory regimes you'll deal with: the substance list has been unchanged since 2015, and the documentation requirements are well-defined. The risk in RoHS isn't the law changing; it's keeping your product portfolio's documentation current as suppliers, materials, and markets shift around it.

Three things to take away:

• RoHS compliance is self-declared, but the burden of proof sits with you. The technical file has to be defensible at homogeneous-material granularity, not just a top-level supplier statement.
• RoHS doesn't sit alone. It is part of the CE marking conformity assessment for EEE, and it overlaps with REACH on hazardous substances. Treating these regulations in isolation creates duplicate work and gaps.
• The teams that stay compliant at portfolio scale don't do it by working harder on each SKU. They do it by structuring product data once, then automating mapping, documentation generation, and change monitoring on top of that data.

If your team is rebuilding RoHS technical files in spreadsheets every time a supplier changes, or chasing supplier declarations across email threads, the bottleneck isn't your team; it's the workflow. Complir automates the product-to-regulation mapping, generates the technical file and EU Declaration of Conformity from structured product data, and continuously flags SKUs affected by exemption renewals or supplier changes. See how Complir handles RoHS documentation across a multi-market product portfolio.

Sources & References

• 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 (recast): consolidated text, EUR-Lex
• Commission Delegated Directive (EU) 2015/863 amending Annex II to Directive 2011/65/EU as regards the list of restricted substances: EUR-Lex (OJ L 137, 4.6.2015)
• Decision No 768/2008/EC on a common framework for the marketing of products: EUR-Lex (OJ L 218, 13.8.2008)
• Regulation (EC) No 1907/2006 (REACH): EUR-Lex, current consolidated version
• European Commission: RoHS Directive overview
• European Commission: RoHS FAQ key guidance document (PDF)
• EN IEC 63000:2018: technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances (CENELEC harmonised standard)

This article is for informational purposes only and does not constitute legal advice. Regulatory requirements may vary by product category, market, and specific circumstances. Consult with a qualified legal professional for compliance guidance specific to your situation.