RoHS compliance: the 10 restricted substances and the paperwork

RoHS compliance is both halves together: materials within the limits, and the paperwork that proves it. The version with ten substances is often called “RoHS 3”; in law it is the same Directive, with its Annex II replaced by Delegated Directive (EU) 2015/863Delegated Directive (EU) 2015/863, RoHS Annex II substance list (four phthalates added)The whole regulationClick opens the law on the EU Publications Office..

Which 10 substances RoHS restricts, and at what limits

Each limit is a maximum by weight in each homogeneous material, not in the whole product.

A homogeneous material is one of uniform composition throughout, or a combination of materials that cannot be separated by unscrewing, cutting, crushing, grinding or abrasion (Art. 3(20)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 3, paragraph 20Click opens the article on EUR-Lex.). A cable sheath, a plastic housing, a solder joint and the coating on a pin each count on their own. A product that is fine “on average” can still fail in one part.

The four phthalates (DEHP, BBP, DBP, DIBP) apply to products placed on the market from 22 July 2019, and to medical devices and monitoring and control instruments from 22 July 2021. A test report that covers only the first six substances misses the phthalates, whatever its date.

The six older substances were in Annex II of the 2011 text. Delegated Directive (EU) 2015/863 replaced Annex II with the ten-substance list (its Art. 1Delegated Directive (EU) 2015/863, RoHS Annex II substance list (four phthalates added)Article 1Click opens the article on EUR-Lex.), and EU countries applied it from 22 July 2019 (its Art. 2(1)Delegated Directive (EU) 2015/863, RoHS Annex II substance list (four phthalates added)Article 2, paragraph 1Click opens the article on EUR-Lex.). Annex II itself carries three notes on the phthalates: the 22 July 2021 date for medical devices, in vitro medical devices and monitoring and control instruments; no phthalate restriction for cables and spare parts for the repair, reuse, updating or upgrading of equipment placed on the market before 22 July 2019 (before 22 July 2021 for those device groups); and no DEHP, BBP or DBP restriction for toys, which already fall under entry 51 of Annex XVII to the REACH Regulation.

Which products are in scope

RoHS covers electrical and electronic equipment in the eleven categories of Annex I (Art. 2(1)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 2, paragraph 1Click opens the article on EUR-Lex.):

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, industrial ones included.
10. Automatic dispensers.
11. Other electrical and electronic equipment not covered by any category above.

Category 11 is the catch-all: since 22 July 2019 it pulls in everything that was outside the older RoHS Directive (Art. 4(3)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 4, paragraph 3Click opens the article on EUR-Lex.). So the real test is the definition, not the list. The product must depend on electric currents or electromagnetic fields to work properly, and “dependent” means needing them for at least one intended function (Art. 3(1)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 3, paragraph 1Click opens the article on EUR-Lex., Art. 3(2)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 3, paragraph 2Click opens the article on EUR-Lex.). A toy whose only electrical part is a light is in, because lighting up is one of its intended functions. Equipment that generates, transfers or measures those currents and fields is in as well.

Cables count when they have a rated voltage below 250 volts and connect equipment to a socket or to other equipment (Art. 3(5)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 3, paragraph 5Click opens the article on EUR-Lex.). Spare parts count too (Art. 3(27)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 3, paragraph 27Click opens the article on EUR-Lex., Art. 4(1)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 4, paragraph 1Click opens the article on EUR-Lex.). A cable or spare part sold for equipment placed on the market before the dates RoHS reached it (1 July 2006 for equipment the older RoHS Directive covered, later dates for medical devices, monitoring and control instruments and the rest) is not caught (Art. 4(4)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 4, paragraph 4Click opens the article on EUR-Lex.).

What is excluded

RoHS does not apply to (Art. 2(4)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 2, paragraph 4Click opens the article on EUR-Lex.):

• equipment needed to protect a country’s essential security interests, including arms, munitions and war material for military purposes;
• equipment designed to be sent into space;
• equipment designed only to be installed as part of another type of equipment that is itself excluded or out of scope, which works only as part of it and can be replaced only by the same specially designed equipment;
• large-scale stationary industrial tools;
• large-scale fixed installations;
• means of transport for persons or goods, except electric two-wheel vehicles that are not type-approved (so an electric scooter or bike without type approval is in scope);
• non-road mobile machinery made available only 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 designed solely for research and development and made available only business to business;
• pipe organs.

Why exemptions are something else

An exemption does not take a product out of RoHS. It allows one named substance in one named use, for a limited time. Annex III lists exemptions for all categories; Annex IV adds some for medical devices and monitoring and control instruments (Art. 4(6)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 4, paragraph 6Click opens the article on EUR-Lex.). Two examples: lead in copper alloy up to 4% by weight (exemption 6(c)), and lead in high-melting-temperature solders of 85% lead or more (exemption 7(a)). Both show an expiry of 30 June 2027 in the consolidated text of 1 July 2026. A product can rely on an exemption until it expires, and past that date only while a renewal applied for in time is still waiting for the Commission’s decision (Art. 5(5)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 5, paragraph 5Click opens the article on EUR-Lex.).

Exemptions run for 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 (Art. 5(2)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 5, paragraph 2Click opens the article on EUR-Lex.). A renewal application is due at least 18 months before expiry, and the existing exemption stays valid until the Commission decides on it (Art. 5(5)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 5, paragraph 5Click opens the article on EUR-Lex.). If renewal is refused, the exemption ends between 12 and 18 months after that decision (Art. 5(6)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 5, paragraph 6Click opens the article on EUR-Lex.).

Why there is no RoHS certificate

The Directive creates no certificate and gives no role to a notified body. Conformity is shown by the manufacturer itself, through internal production control: module A of Annex II to Decision No 768/2008/EC (Art. 7(b)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 7, point (b)Click opens the article on EUR-Lex.). The manufacturer writes the technical documentation, signs the declaration and affixes the CE marking. By signing, it takes responsibility for the product’s compliance (Art. 13(3)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 13, paragraph 3Click opens the article on EUR-Lex.).

A laboratory test report is useful evidence inside that file. It is not a certificate and it does not replace the declaration. A “RoHS certificate” sold to you by a third party is, at most, a test report under another name. The same holds for GPSR. The declaration of conformity guide explains which laws ask for a declaration and which do not.

What the EU declaration of conformity under RoHS contains

The declaration states that the substance limits of Art. 4Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 4Click opens the article on EUR-Lex. have been met (Art. 13(1)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 13, paragraph 1Click opens the article on EUR-Lex.). Its content is fixed by Annex VI (Art. 13(2)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 13, paragraph 2Click opens the article on EUR-Lex.):

1. A unique identification number for the product.
2. The name and address of the manufacturer or its authorised representative.
3. A statement that it is issued under the sole responsibility of the manufacturer (or installer).
4. The object of the declaration, identified so it can be traced, with a photograph where appropriate.
5. A statement that the object conforms to Directive 2011/65/EUDirective 2011/65/EU, Restriction of Hazardous Substances (RoHS)The whole regulationClick opens the law on the EU Publications Office..
6. Where applicable, the harmonised standards or technical specifications used.
7. Additional information.

Then: signed for and on behalf of whom, place and date of issue, name, function and signature.

The declaration is kept up to date and translated into the language or languages of the EU country where the product is placed or made available; each EU country sets which. The manufacturer keeps it for 10 years after the product is placed on the market (Art. 7(d)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 7, point (d)Click opens the article on EUR-Lex.).

Equipment rated between 50 and 1,000 volts AC or 75 and 1,500 volts DC also falls under the Low Voltage Directive (its Art. 1Directive 2014/35/EU, Low Voltage Directive (consolidated text of 30 May 2026)Article 1Click opens the article on EUR-Lex.). Where such equipment is under more than one EU act that requires a declaration, the low-voltage Directive requires one single declaration naming all of them (Directive 2014/35/EU, Art. 15(3)Directive 2014/35/EU, Low Voltage Directive (consolidated text of 30 May 2026)Article 15, paragraph 3Click opens the article on EUR-Lex.). So one declaration for a mains lamp can name RoHS, low-voltage and electromagnetic compatibility together; the second of those laws is the EMC Directive.

How CE marking works under RoHS

The CE marking goes on the finished product or its data plate, visibly, legibly and indelibly. Only where that is impossible or unwarranted does it go on the packaging and the accompanying documents instead. It is affixed before the product is placed on the market (Art. 15(1)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 15, paragraph 1Click opens the article on EUR-Lex., Art. 15(2)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 15, paragraph 2Click opens the article on EUR-Lex.). The general rules for the mark are those of Art. 30Regulation (EC) No 765/2008, accreditation and market surveillance (CE marking)Article 30Click opens the article on EUR-Lex. of Regulation (EC) No 765/2008Regulation (EC) No 765/2008, accreditation and market surveillance (CE marking)The whole regulationClick opens the law on the EU Publications Office. (Art. 14Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 14Click opens the article on EUR-Lex.). How the mark is drawn, sized and applied across all product laws is CE marking.

A product bearing the CE marking is presumed to comply with RoHS unless there is evidence to the contrary (Art. 16(1)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 16, paragraph 1Click opens the article on EUR-Lex.). That presumption is why a distributor’s check can stop at the mark and the documents, and why a false mark is punished on its own (Art. 15(3)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 15, paragraph 3Click opens the article on EUR-Lex.).

What the technical documentation holds

The whole file across the CE laws is in CE technical file; this is the RoHS part.

The manufacturer draws up the technical documentation (Art. 7(b)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 7, point (b)Click opens the article on EUR-Lex.). Under module A it must make it possible to assess the product’s conformity and include an adequate analysis and assessment of the risks. Where applicable it holds at least:

• a general description of the product;
• design and manufacturing drawings and schemes of components, sub-assemblies and circuits, with the explanations needed to read them;
• the list of harmonised standards or other technical specifications applied;
• results of design calculations and examinations;
• test reports.

The harmonised standard for RoHS technical documentation is EN IEC 63000:2018, published by Commission Implementing Decision (EU) 2020/659, Annex I. It replaced EN 50581:2012, whose reference was withdrawn from 18 November 2021 (Annex II of that Decision). Materials, components and products assessed in line with a harmonised standard are presumed to comply (Art. 16(2)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 16, paragraph 2Click opens the article on EUR-Lex.).

Where another EU law already requires a conformity assessment at least as strict, RoHS compliance can be shown inside that procedure, with one set of technical documentation (Art. 7(c)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 7, point (c)Click opens the article on EUR-Lex., Art. 13(2)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 13, paragraph 2Click opens the article on EUR-Lex.).

The manufacturer keeps the file for 10 years after placing the product on the market (Art. 7(d)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 7, point (d)Click opens the article on EUR-Lex.). An importer does not have to hold it, but must make sure it can be made available to authorities on request (Art. 9(g)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 9, point (g)Click opens the article on EUR-Lex.).

What each role owes

In short: the manufacturer produces the proof, the importer makes sure it exists before the product enters the EU, and the distributor checks what is visible. Put your own brand on a product and you are the manufacturer, whoever made it (Art. 11Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 11Click opens the article on EUR-Lex.).

What changes when you sell online from outside the EU

An online offer targeted at end users in the EU counts as making the product available on the EU market (Art. 6Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 6Click opens the article on EUR-Lex. of Regulation (EU) 2019/1020). RoHS defines an importer as someone based in the EU (Art. 3(9)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 3, paragraph 9Click opens the article on EUR-Lex.), so a seller outside the EU shipping straight to EU buyers has no importer standing behind it.

RoHS is one of the laws listed in Art. 4(5)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 5Click opens the article on EUR-Lex. of Regulation (EU) 2019/1020Regulation (EU) 2019/1020, Market Surveillance RegulationThe whole regulationClick opens the law on the EU Publications Office.. A product under it may be placed on the market only if an economic operator based in the EU is responsible for it (Art. 4(1)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 1Click opens the article on EUR-Lex.). That operator is any of these: an EU manufacturer; the importer, where the manufacturer is outside the EU; an authorised representative with a written mandate; or, only where none of those is established in the EU, an EU fulfilment service provider for the products it handles (Art. 4(2)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 2Click opens the article on EUR-Lex.). It keeps the declaration of conformity available, makes sure the technical documentation can be produced, and cooperates with authorities (Art. 4(3)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 3Click opens the article on EUR-Lex.). Its name and contact details, postal address included, go on the product, its packaging, the parcel or an accompanying document (Art. 4(4)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 4Click opens the article on EUR-Lex.). Who can hold that role and what it costs is the EU Responsible Person; how it differs from an authorised representative is EU responsible person vs authorised representative.

What to get from your supplier

1. The EU declaration of conformity for the exact model you sell, with all seven Annex VI points, naming Directive 2011/65/EUDirective 2011/65/EU, Restriction of Hazardous Substances (RoHS)The whole regulationClick opens the law on the EU Publications Office., signed and dated. A declaration that also lists the low-voltage or radio equipment Directive is normal.
2. The technical documentation, or a written commitment that the manufacturer will hand it to an EU authority on request for 10 years after the product is placed on the market. As importer, you answer for that availability (Art. 9(g)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 9, point (g)Click opens the article on EUR-Lex.).
3. The evidence behind it: test reports on the homogeneous materials, or material declarations from the component suppliers, covering all ten substances. A report covering six substances misses the four phthalates restricted since 22 July 2019.
4. The exemptions relied on, if any, by Annex III or IV number, so you know when each one runs out.
5. The markings on the product: the CE marking, a type, batch or serial number, and the manufacturer’s name and contact address.
6. Who supplied what, kept on your side: the supplier’s details and your customers’ business details, for 10 years (Art. 12Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 12Click opens the article on EUR-Lex.).

What happens if you do nothing

An importer must make sure the declaration, the technical documentation, the CE marking and the addresses exist before placing the product on the market, and a distributor must check the mark, the documents and the addresses before selling (Art. 9(b)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 9, point (b)Click opens the article on EUR-Lex., Art. 10(a)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 10, point (a)Click opens the article on EUR-Lex.). Without them the product stays off the shelf. Once a product that does not conform is on the market, the manufacturer and importer must bring it into conformity, withdraw it or recall it, and inform the authorities of every EU country where it was sold (Art. 7(i)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 7, point (i)Click opens the article on EUR-Lex., Art. 9(f)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 9, point (f)Click opens the article on EUR-Lex., Art. 10(c)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 10, point (c)Click opens the article on EUR-Lex.). Penalties are set by each EU country, which must make them effective, proportionate and dissuasive (Art. 23Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 23Click opens the article on EUR-Lex.). For misuse of the CE marking, penalties may include criminal sanctions for serious infringements (Art. 15(3)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 15, paragraph 3Click opens the article on EUR-Lex.).

How RoHS sits next to REACH and GPSR

RoHS does not replace other EU law on chemicals, safety and health. A product that passes RoHS still has to meet the REACH Regulation and the EU waste rules (Art. 2(3)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 2, paragraph 3Click opens the article on EUR-Lex.). RoHS deals only with substances; electrical safety, electromagnetic compatibility and radio have their own laws (Radio Equipment Directive). RoHS is one of the EU’s product-specific laws, so it also changes which parts of GPSR reach the product: there is no GPSR certificate shows the split.

What the law leaves open

• How to measure against the limits. Art. 4(2)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 4, paragraph 2Click opens the article on EUR-Lex. lets the Commission adopt detailed rules for complying with the limits, surface coatings included. In its 2016 report on those powers it had not adopted any (COM(2016) 215, section 3.1), and its 2021 report records no change (COM(2021) 641, section 3.1). Until such rules exist, how a thin plating or a coating is sampled comes from the harmonised standard and the laboratory, not from the Directive.
• How much testing is enough. Module A asks for documentation that makes it possible to assess conformity and for test reports “wherever applicable”. It sets no number of tests and no duty to use an outside laboratory. How much evidence is enough rests on the manufacturer’s own risk assessment.
• Whether a listed expiry date is the real one. An exemption stays valid until the Commission decides on a renewal application filed in time (Art. 5(5)Directive 2011/65/EU, Restriction of Hazardous Substances (RoHS)Article 5, paragraph 5Click opens the article on EUR-Lex.), so a date already passed in Annex III can still be live. The Directive’s own text does not show which renewals are pending.

What you can skip