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RoHS Chemicals & Substances 11 min Changing in the next 12 months

RoHS: RoHS Directive (Directive 2011/65/EU), explained

The RoHS Directive restricts lead, mercury, cadmium, hexavalent chromium, two brominated flame retardants and four phthalates in electrical and electronic equipment on the EU market, with manufacturers proving compliance through technical documentation, an EU declaration of conformity and CE marking. It has applied since 3 January 2013; from 13 August 2027 ECHA takes over assessing exemptions.

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Reviewed 5 October 2026 by Conphora compliance team · Next review 13 March 2027 · Not legal advice

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Who it applies to

Covered by the act

  • Electrical and electronic equipment that depends on electric currents or electromagnetic fields for at least one intended function, or that generates, transfers or measures such currents and fields, rated up to 1 000 V AC or 1 500 V DC
  • All eleven Annex I categories: large and small household appliances, IT and telecommunications equipment, consumer equipment, lighting, electrical and electronic tools, toys, leisure and sports equipment, medical devices, monitoring and control instruments including industrial ones, automatic dispensers, and all other equipment not covered by those categories
  • Cables with a rated voltage below 250 V that connect equipment to the outlet or to other equipment, and spare parts for repair, reuse, updating or upgrading of equipment
  • The ten restricted substances in Annex II: lead, mercury, cadmium, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP and DIBP, measured per homogeneous material
  • The economic operators in the chain: manufacturers, authorised representatives, importers and distributors

Derived and downstream products

  • The limits apply per homogeneous material, meaning a material of uniform composition or a combination that cannot be separated mechanically by unscrewing, cutting, crushing, grinding or abrasion, not per product (Art. 3(20) and Art. 4(2))
  • Equipment specifically designed to be installed as part of excluded or out-of-scope equipment, which can function only as part of it and can only be replaced by the same specifically designed equipment, is outside the directive (Art. 2(4)(c))
  • Applications listed in Annexes III and IV are exempt for as long as the exemption runs; renewal applications filed at least 18 months before expiry keep the exemption valid until the Commission decides (Art. 4(6), Art. 5(5) and Art. 5(6))
  • Cables and spare parts for equipment placed on the market before the relevant compliance date, and reused spare parts in auditable closed-loop business-to-business systems, are exempt until the dates in Article 4(4) and (5)
  • Where other Union legislation requires a conformity assessment at least as stringent, RoHS compliance may be demonstrated within that procedure with a single technical documentation (Art. 7(c) and Art. 13(2))

Roles under the act

Manufacturer (including brand owners)

Any natural or legal person who manufactures an EEE or who has an EEE designed or manufactured and markets it under his name or trademark; an importer or distributor that sells under its own brand or modifies equipment in a way that may affect compliance is treated as the manufacturer.

Source · Art. 3(6) and Art. 11
Authorised representative

Any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks; the mandate cannot cover the duty to design and manufacture to Article 4 or to draw up the technical documentation.

Source · Art. 3(7) and Art. 8(a)
Importer

Any natural or legal person established within the Union who places an EEE from a third country on the Union market.

Source · Art. 3(9)
Distributor (wholesaler or retailer)

Any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes an EEE available on the market.

Source · Art. 3(8)

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Does RoHS apply to your product?

Three questions, a first answer from the regulation’s own scope rules. No account needed.

The rules behind this check
  1. Equipment rated above 1 000 V AC or 1 500 V DC, or not dependent on electricity to function · any · any Not in scope Electrical and electronic equipment is defined as equipment dependent on electric currents or electromagnetic fields for at least one intended function, or generating, transferring or measuring them, and designed for use with a voltage rating not exceeding 1 000 V AC and 1 500 V DC; equipment outside that definition is not covered. Source · Art. 3(1) and Art. 3(2)
  2. Equipment for the essential security interests of Member States, arms, munitions, war material or equipment designed to be sent into space, Large-scale stationary industrial tool or large-scale fixed installation, Means of transport for persons or goods other than electric two-wheel vehicles that are not type-approved, or non-road mobile machinery made available exclusively for professional use, Active implantable medical device, professional photovoltaic panel, business-to-business research and development equipment or pipe organ · any · any Not in scope Article 2(4) excludes equipment for the essential security interests of Member States including arms, munitions and war material, equipment designed to be sent into space, equipment specifically designed as part of excluded equipment, large-scale stationary industrial tools, large-scale fixed installations, means of transport for persons or goods other than non-type-approved electric two-wheelers, non-road mobile machinery made available exclusively for professional use, active implantable medical devices, professionally installed photovoltaic panels, business-to-business research and development equipment and pipe organs. Source · Art. 2(4)
  3. Cables below 250 V and spare parts for repair, reuse, updating or upgrading · any · any It depends Cables and spare parts for repair, reuse, updating or upgrading must comply, except where the equipment they serve was placed on the market before the relevant compliance date (1 July 2006 for the original categories, 22 July 2014, 2016, 2017 and 2019 for the later ones) or benefited from an exemption that has since expired, and except reused spare parts moving in auditable closed-loop business-to-business systems within the Article 4(5) windows. Source · Art. 4(1), Art. 4(4) and Art. 4(5)
  4. Medical devices and in vitro diagnostic medical devices (category 8), Monitoring and control instruments, including industrial monitoring and control instruments (category 9) · Manufacturer (including brand owners), Importer, Distributor (wholesaler or retailer), Authorised representative · any In scope Medical devices and monitoring and control instruments placed on the market from 22 July 2014, in vitro diagnostic medical devices from 22 July 2016 and industrial monitoring and control instruments from 22 July 2017 must comply, with the phthalate restriction applying from 22 July 2021 and category-specific Annex IV exemptions with validity periods of up to seven years. Source · Art. 4(3), Art. 5(2), Annex II and Annex IV
  5. Household appliances, consumer electronics, lighting, tools, toys and other equipment in Annex I categories 1 to 7 and 10, IT and telecommunications equipment (category 3), Other electrical and electronic equipment not covered by categories 1 to 10 (category 11) · Manufacturer (including brand owners), Importer, Distributor (wholesaler or retailer), Authorised representative · any In scope Equipment in Annex I categories 1 to 7 and 10 has had to comply since the directive applied, and all other equipment (category 11) since 22 July 2019; the obligations fall on the manufacturer, authorised representative, importer and distributor and contain no company-size threshold, subject only to the Annex III exemptions. Source · Art. 2(1), Art. 4(1), Art. 4(3), Art. 4(6) and Annex I
  6. any · any · any It depends Whether the directive applies turns on whether the product meets the definition of electrical and electronic equipment, whether an Article 2(4) exclusion applies, and which role the operator holds. Source · Art. 2 and Art. 3

Key dates

  1. Directive 2011/65/EU adopted by the European Parliament and the Council as a recast of Directive 2002/95/EC Source · title and signature block after Art. 28
  2. Entry into force, the twentieth day after publication in OJ L 174 of 1 July 2011 Source · Art. 27
  3. Deadline for Member States to transpose the directive and to notify their penalty rules to the Commission Source · Art. 23 and Art. 25(1)
  4. Directive 2002/95/EC and its amending acts repealed; the recast directive applies through national law Source · Art. 26
  5. Substance restrictions apply to medical devices and monitoring and control instruments placed on the market from this date Source · Art. 4(3)
  6. Delegated Directive (EU) 2015/863 in force: the four phthalates DEHP, BBP, DBP and DIBP added to Annex II with a 0,1 % limit, applying from 22 July 2019 Source · Art. 1, Art. 2 and Art. 3
  7. Substance restrictions apply to in vitro diagnostic medical devices placed on the market from this date Source · Art. 4(3)
  8. Substance restrictions apply to industrial monitoring and control instruments placed on the market from this date Source · Art. 4(3)
  9. Directive (EU) 2017/2102 in force: pipe organs and non-road mobile machinery with a traction drive excluded, the secondary-market and spare-part rules for category 11 added; transposition by 12 June 2019 Source · Art. 1, Art. 2 and Art. 3
  10. Open scope: restrictions apply to all other electrical and electronic equipment that was outside Directive 2002/95/EC (category 11); the phthalate restriction applies to categories 1 to 7, 10 and 11 Source · Art. 4(3) and Annex II
  11. The phthalate restriction applies to medical devices, in vitro diagnostic medical devices and monitoring and control instruments, including industrial ones Source · Annex II
  12. Directive (EU) 2025/2456 in force: from 13 August 2027 the European Chemicals Agency handles exemption applications and prepares restriction dossiers Source · Art. 1, Art. 2 and Art. 3
  13. Delegated Directives (EU) 2025/1802, 2025/2363 and 2025/2364 apply: renewed and narrowed Annex III exemptions for lead in high-melting-temperature solders (7(a)), lead in glass and ceramic components (7(c)) and lead as an alloying element in steel, aluminium and copper (6(a) to 6(c)) Source · Art. 2Source · Art. 2Source · Art. 2
  14. Expiry of the general exemption 6(a) for lead in steel for machining and galvanised steel, and of 6(b)-I for lead in recycled aluminium for categories 1 to 7 and 10 Source · Annex, points 6(a) and 6(b)-I
  15. Expiry of the general exemption 6(b) for lead as an alloying element in aluminium up to 0,4 % by weight and of 6(b)-II for categories 1 to 7 and 10 Source · Annex, points 6(b) and 6(b)-II
  16. Expiry of exemptions 6(a)-I and 6(a)-II for lead in machining and hot-dip galvanised steel, 6(b)-I and 6(b)-II for aluminium in categories 9 industrial and 11, 6(b)-III for lead in aluminium casting alloys, 6(c) for copper alloys with up to 4 % lead, 7(a) for lead in high-melting-temperature solders and 7(c)-I for lead in glass or ceramic components Source · AnnexSource · Annex, point 7(a)Source · Annex, point 7(c)-I
  17. Directive (EU) 2025/2456 applies: exemption applications go to the European Chemicals Agency, its committees give opinions within 12 months, the Commission decides within 9 months of the opinions, and Annex II is reviewed at least every four years on the basis of restriction dossiers Source · Art. 1 and Art. 2
  18. Expiry of the narrowed solder exemptions 7(a)-I to 7(a)-VII and of the glass and ceramic exemptions 7(c)-II, 7(c)-V and 7(c)-VI Source · Annex, points 7(a)-I to 7(a)-VIISource · Annex, points 7(c)-II, 7(c)-V and 7(c)-VI
  19. End of the derogation for reused spare parts recovered from category 11 equipment placed on the market before 22 July 2019 and used in equipment placed on the market before this date Source · Art. 4(5)(e)

What you must do

Obligations by role

Manufacturer (including brand owners)13
  • Design and manufacture equipment so that it, including its cables and spare parts, contains no more than 0,1 % by weight of lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP or DIBP and no more than 0,01 % cadmium in any homogeneous material, unless an Annex III or IV exemption covers the application. Art. 4(1), Art. 4(2), Art. 4(6), Art. 7(a) and Annex II
  • Draw up the technical documentation; where another Union act requires a conformity assessment at least as stringent, RoHS compliance may be shown within a single technical documentation. Art. 7(b) and Art. 13(2)
  • Carry out, or have carried out, the internal production control procedure of Module A of Annex II to Decision No 768/2008/EC. Art. 7(b)
  • Draw up the EU declaration of conformity per Annex VI, translated into the languages the Member State requires. Art. 7(c) and Art. 13
  • Affix the CE marking to the finished equipment or its data plate, or to the packaging and accompanying documents where the equipment does not allow it, before placing it on the market. Art. 7(c) and Art. 15
  • Keep the technical documentation and the EU declaration of conformity for 10 years after the equipment was placed on the market. Art. 7(d)
  • Keep procedures in place for series production to remain in conformity, taking account of changes in design, characteristics and the standards or specifications referenced. Art. 7(e)
  • Keep a register of non-conforming equipment and product recalls and keep distributors informed of it. Art. 7(f)
  • Mark the equipment with a type, batch or serial number or other identifier and with your name, registered trade name or trade mark and a single contact address, or where size or nature does not allow it, on the packaging or in an accompanying document; stricter marking rules in other Union acts prevail. Art. 7(g) and Art. 7(h)
  • Track the expiry dates of the Annex III and IV exemptions you use and apply for renewal at least 18 months before expiry, from 13 August 2027 to the European Chemicals Agency. Art. 5(5) and Annex VArt. 1 and Art. 2
  • If you consider or have reason to believe that equipment you placed on the market does not conform, immediately bring it into conformity, withdraw or recall it, and inform the competent authorities of the Member States where you made it available with details of the non-compliance and the corrective measures. Art. 7(i)
  • On a reasoned request, provide all information and documentation demonstrating conformity in a language the authority understands, and cooperate on action to bring the equipment into compliance. Art. 7(j)
  • Be able to identify the economic operators that supplied you and that you supplied, for 10 years after the equipment was placed on the market. Art. 12
Authorised representative3
  • Act under a written mandate that at least lets you keep the EU declaration of conformity and technical documentation at the disposal of the surveillance authorities for 10 years, provide conformity information and documentation on reasoned request, and cooperate with the authorities on compliance action. Art. 8(b)
  • Do not take over the manufacturer's duty to design and manufacture to Article 4 or to draw up the technical documentation; those cannot form part of the mandate. Art. 8(a)
  • Be able to identify the economic operators that supplied you and that you supplied for 10 years after placing the equipment on the market; you may also apply for exemptions on the manufacturer's behalf. Art. 12 and Annex V
Importer8
  • Place only compliant equipment on the market, and before doing so check that the manufacturer carried out the conformity assessment, drew up the technical documentation, affixed the CE marking, supplied the required documents and applied the identification and address markings; hold non-conforming equipment back and inform the manufacturer and the market surveillance authorities. Art. 9(a), Art. 9(b) and Art. 9(c)
  • Indicate your name, registered trade name or trade mark and a contact address on the equipment or, where not possible, on its packaging or in an accompanying document; stricter marking rules in other Union acts prevail. Art. 9(d)
  • Keep a register of non-compliant equipment and recalls and keep distributors informed of it. Art. 9(e)
  • If equipment you placed on the market does not conform, immediately take corrective measures, withdraw or recall it, and inform the competent authorities of the Member States concerned with details of the non-compliance and the measures taken. Art. 9(f)
  • Keep a copy of the EU declaration of conformity for 10 years after placing on the market and ensure the technical documentation can be made available on request. Art. 9(g)
  • On a reasoned request, provide all information and documentation demonstrating conformity in a language the authority understands, and cooperate on action to bring the equipment into compliance. Art. 9(h)
  • Be able to identify the economic operators that supplied you and that you supplied, for 10 years after the equipment was placed on the market. Art. 12
  • If you place equipment on the market under your own name or trade mark, or modify equipment in a way that may affect compliance, you carry the manufacturer's obligations under Article 7. Art. 11
Distributor (wholesaler or retailer)5
  • Act with due care and, before making equipment available, verify that it bears the CE marking, is accompanied by the required documents in a language consumers and end users in the Member State understand, and that the manufacturer and importer have applied their identification and address markings; hold non-conforming equipment back and inform the manufacturer or importer and the authorities. Art. 10(a) and Art. 10(b)
  • If equipment you made available does not conform, make sure corrective measures are taken to bring it into conformity, withdraw or recall it, and immediately inform the competent authorities of the Member States concerned. Art. 10(c)
  • On a reasoned request, provide all information and documentation demonstrating conformity in a language the authority understands, and cooperate on action to bring the equipment into compliance. Art. 10(d)
  • Be able to identify the economic operators that supplied you and that you supplied, for 10 years after the equipment was placed on the market. Art. 12
  • If you sell under your own name or trade mark or modify equipment in a way that may affect compliance, you take on the manufacturer's obligations. Art. 11

RoHS in plain terms

The RoHS Directive, formally Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment, lays down rules on the restriction of hazardous substances in electrical and electronic equipment (EEE) to protect human health and the environment, including the environmentally sound recovery and disposal of waste EEE (Art. 1). Its single operative rule is that equipment placed on the market, including cables and spare parts for its repair, reuse, updating or upgrading, must not contain the Annex II substances above the maximum concentration in homogeneous materials (Art. 4(1) and (2)), unless an Annex III or IV exemption covers the application (Art. 4(6)).

The 2011 text is a recast of Directive 2002/95/EC aligned with the New Legislative Framework: it added CE marking, the EU declaration of conformity and the economic operator duties, and it opened the scope in stages to medical devices, monitoring and control instruments and finally, from 22 July 2019, to all other equipment. As a directive it works through national law, which Member States had to adopt by 2 January 2013 (Art. 25).

Official text Read the directive on EUR-Lex: Directive 2011/65/EU (CELEX 32011L0065), or the consolidated text of 1 July 2026 that incorporates the 88 amending acts, including the current Annex III and IV exemptions.

Scope

Electrical and electronic equipment is equipment that depends on electric currents or electromagnetic fields to fulfil at least one intended function, or that generates, transfers or measures such currents and fields, designed for use with a voltage rating not exceeding 1 000 V AC or 1 500 V DC (Art. 3(1) and (2)). Annex I sorts it into eleven categories: large and small household appliances, IT and telecommunications equipment, consumer equipment, lighting, tools, toys, leisure and sports equipment, medical devices, monitoring and control instruments including industrial ones, automatic dispensers and, since 22 July 2019, all other EEE not covered by the first ten (Annex I and Art. 4(3)). Cables below 250 V connecting equipment and spare parts are covered with the equipment they serve (Art. 3(5) and Art. 4(1)).

Article 2(4) excludes equipment for the essential security interests of Member States, equipment designed to be sent into space, equipment specifically designed to be installed as part of excluded or out-of-scope equipment, large-scale stationary industrial tools, large-scale fixed installations, means of transport other than non-type-approved electric two-wheelers, non-road mobile machinery for professional use, active implantable medical devices, professionally installed photovoltaic panels, business-to-business research and development equipment and pipe organs. The directive applies without prejudice to safety, health and chemicals legislation, in particular REACH, and to waste legislation (Art. 2(3)).

The duties fall on the economic operators: manufacturer, authorised representative, importer and distributor (Art. 3(10)). A manufacturer is whoever manufactures EEE or has it designed or manufactured and markets it under his own name or trademark (Art. 3(6)), and an importer or distributor that sells under its own brand or modifies equipment in a way that may affect compliance takes on the manufacturer’s obligations (Art. 11).

The 10 restricted substances and their limits

Annex II lists lead, mercury, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) at a maximum of 0,1 % by weight, and cadmium at 0,01 %, in each homogeneous material. A homogeneous material is one material of uniform composition throughout, or a combination of materials that cannot be disjointed or separated by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasion (Art. 3(20)), so a solder joint, a coating or a plastic housing is each assessed on its own. The four phthalates were added by Delegated Directive (EU) 2015/863 and apply from 22 July 2019, and from 22 July 2021 for medical devices and monitoring and control instruments; DEHP, BBP and DBP in toys remain regulated by REACH entry 51 (Annex II).

The restriction reached medical devices and monitoring and control instruments on 22 July 2014, in vitro diagnostic devices on 22 July 2016, industrial monitoring and control instruments on 22 July 2017 and all other equipment on 22 July 2019 (Art. 4(3)). Cables and spare parts for equipment placed on the market before those dates, or before an exemption it relied on expired, stay exempt (Art. 4(4)), and reused spare parts recovered from such equipment may circulate in auditable closed-loop business-to-business return systems, with the reuse notified to the consumer, within the windows of Article 4(5), the last of which closes on 22 July 2029. The Commission must consider reviewing Annex II periodically, using the criteria of Article 6, and from 13 August 2027 at least every four years on the basis of restriction dossiers prepared by the European Chemicals Agency or a Member State (Art. 6 as amended by Directive (EU) 2025/2456).

Exemptions

Annex III lists exemptions for all categories and Annex IV exemptions specific to medical devices and monitoring and control instruments. The Commission adds or deletes entries by delegated act where elimination or substitution through design or material changes is scientifically or technically impracticable, the reliability of substitutes is not ensured, or the total negative impacts of substitution are likely to outweigh the benefits, taking account of the availability of substitutes, socioeconomic impact and innovation (Art. 5(1)). Exemptions are valid for up to five years for categories 1 to 7, 10 and 11 and up to seven years for categories 8 and 9, and may be renewed; an application for renewal made at least 18 months before expiry keeps the exemption valid until the Commission decides, and a rejected renewal or revocation takes effect 12 to 18 months after the decision (Art. 5(2), (5) and (6)). Applications follow Annex V and may be made by a manufacturer, its authorised representative or any economic operator in the supply chain.

The consolidated text of 1 July 2026 incorporates 88 amending acts, all but Directive (EU) 2017/2102 being Commission delegated directives adjusting the annexes. The most recent, Delegated Directives (EU) 2025/1802, 2025/2363 and 2025/2364 of 8 September 2025, renewed the lead exemptions for high-melting-temperature solders (point 7(a)), glass or ceramic components (point 7(c)) and lead as an alloying element in steel, aluminium and copper (points 6(a) to 6(c)) in narrowed sub-entries that apply from 1 July 2026 and expire between 11 December 2026 and 31 December 2027. From 13 August 2027, Directive (EU) 2025/2456 moves the handling of applications to the European Chemicals Agency: it checks completeness, consults the public and obtains opinions from its Committee for Socioeconomic Analysis and, where relevant, its Committee for Risk Assessment within 12 months, after which the Commission decides within 9 months.

How RoHS compliance is demonstrated

No notified body is involved. The manufacturer designs and manufactures to Article 4, draws up the technical documentation and carries out internal production control in line with Module A of Annex II to Decision No 768/2008/EC, then draws up the EU declaration of conformity per Annex VI and affixes the CE marking to the finished equipment (Art. 7(a) to (c), Art. 13 and Art. 15). Where other Union legislation requires a conformity assessment at least as stringent, RoHS compliance may be demonstrated within that procedure with a single technical documentation (Art. 7(c) and Art. 13(2)). Equipment bearing the CE marking is presumed compliant in the absence of evidence to the contrary, and materials, components and equipment tested or assessed in accordance with harmonised standards published in the Official Journal are presumed to comply (Art. 16). Documentation and the declaration are kept for 10 years (Art. 7(d)).

Manufacturers also keep series production in conformity, keep a register of non-conforming equipment and recalls and inform distributors, mark the equipment with an identifier and their name and address, take corrective action and inform the authorities when equipment does not conform, and cooperate on request (Art. 7(e) to (j)). Authorised representatives act under a mandate that must at least cover keeping the documents and cooperating with authorities (Art. 8). Importers place only compliant equipment on the market, verify the manufacturer’s work, add their own name and address, keep a register of non-compliant equipment and recalls, take corrective action and keep the declaration for 10 years (Art. 9). Distributors verify the CE marking, documents and markings before making equipment available and see that corrective action is taken (Art. 10). Every operator identifies its suppliers and customers for 10 years (Art. 12).

How RoHS relates to REACH and WEEE

RoHS applies without prejudice to REACH, Regulation (EC) No 1907/2006, and the review of Annex II must stay coherent with REACH and take account of its Annexes XIV and XVII (Art. 2(3) and Art. 6(1)). The two regimes overlap where the same substance is restricted under both, which is why the phthalate restriction for toys is left to REACH entry 51 (Annex II). The directive complements the WEEE rules on the collection and treatment of waste equipment by keeping the restricted substances out of the products in the first place, and applications for exemptions must address the preparation for reuse and recycling of waste EEE (Art. 1 and Annex V, point (e)).

Enforcement and consequences

Market surveillance follows Regulation (EU) 2019/1020, which replaced the Articles 15 to 29 of Regulation (EC) No 765/2008 that Article 18 of the directive cites, including controls on equipment entering the Union market. Manufacturers, importers and distributors that consider or have reason to believe that equipment does not conform must immediately bring it into conformity, withdraw or recall it and inform the competent authorities of the Member States concerned (Art. 7(i), Art. 9(f) and Art. 10(c)). Member States lay down effective, proportionate and dissuasive penalties for infringements of their transposing provisions, notified to the Commission by 2 January 2013 (Art. 23), and must penalise improper use of the CE marking, with criminal sanctions possible for serious infringements (Art. 15(3)). In Denmark, the directive is implemented by the RoHS executive order, Miljøstyrelsen’s chemicals inspection supervises the rules, and importing or selling non-compliant equipment is prohibited.

How Conphora helps

Conphora monitors the RoHS Directive and every delegated directive that adds, renews or closes an exemption, maps your products and their homogeneous materials against the Annex II limits and the exemptions you rely on, and flags expiring exemptions in time for substitution or a renewal application. The platform helps you build and keep the technical documentation, the EU declaration of conformity and the 10-year records, and alerts you when a substance review or the hand-over to the European Chemicals Agency changes what you must do.

See how Conphora works · See plans and pricing

Sources

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

Penalties

Enforced by National market surveillance authorities enforce the national laws transposing the directive with the powers of Regulation (EU) 2019/1020, which since 16 July 2021 replaces the market-surveillance chapter of Regulation (EC) No 765/2008 that the directive cites; in Denmark, Miljøstyrelsen's chemicals inspection (Kemikalieinspektionen) supervises the Danish RoHS executive order, and importing or selling non-compliant equipment in Denmark is prohibited. The toolkit is corrective action, withdrawal or recall, market surveillance controls including on equipment entering the Union, and national penalties that must be effective, proportionate and dissuasive, with criminal sanctions possible for serious misuse of the CE marking.

Member States lay down the rules on penalties for infringements of their national transposing provisions; the penalties must be effective, proportionate and dissuasive and had to be notified to the Commission by 2 January 2013. Member States must also provide penalties for improper use of the CE marking, which may include criminal sanctions for serious infringements and must be proportionate to the seriousness of the offence. Market surveillance follows Regulation (EU) 2019/1020, which replaced the Articles 15 to 29 of Regulation (EC) No 765/2008 that Article 18 of the directive cites, including controls on equipment entering the Union market, and manufacturers, importers and distributors must bring non-conforming equipment into conformity, withdraw or recall it and inform the authorities. In Denmark, the directive is implemented by the RoHS executive order, Miljøstyrelsen's chemicals inspection supervises the rules, and importing or selling non-compliant equipment is prohibited.

Source · Art. 23, Art. 15(3), Art. 18, Art. 7(i), Art. 9(f) and Art. 10(c)Source

What changed

Entry into force, amendments and Compliance Radar entries for RoHS, newest first.

  1. Amendment

    European Chemicals Agency takes over RoHS exemptions and restrictions

    Directive (EU) 2025/2456 applies from this date: exemption applications under Article 5 are made to the European Chemicals Agency, whose Committee for Socioeconomic Analysis and, where relevant, Committee for Risk Assessment give opinions within 12 months before the Commission decides within 9 months; the list of restricted substances in Annex II is reviewed at least every four years on the basis of restriction dossiers prepared by the Agency or a Member State under the new Articles 6a to 6c and Annex Va.

    Source · Art. 1 and Art. 2
  2. Guidance

    Applicability check: the e-bike carve-back added to the transport category

    The category for means of transport now states the Article 2(4)(f) carve-back: electric two-wheel vehicles that are not type-approved, such as most e-bikes and e-scooters, are not excluded and remain within the directive; the rule note already said so.

    Source · Art. 2(4)(f)
  3. Applies

    Renewed and narrowed lead exemptions apply

    Member States apply the measures transposing Delegated Directives (EU) 2025/1802, 2025/2363 and 2025/2364: the Annex III exemptions for lead in high-melting-temperature solders (7(a)), lead in glass or ceramic components (7(c)) and lead as an alloying element in steel, aluminium and copper (6(a) to 6(c)) continue in narrowed sub-entries with expiries between 11 December 2026 and 31 December 2027.

    Source · Art. 2 and AnnexSource · Art. 2 and AnnexSource · Art. 2 and Annex
  4. Radar

    EU JACOP 2025 campaign: over half of tested electronics breach RoHS hazardous-substance limits

    A DG GROW-coordinated JACOP 2025 market surveillance campaign tested 173 cheap electric and electronic gadgets and found 53% non-compliant \or marking issues \u2013 mostly excess lead/cadmium in solder points and phthalates in soft-PVC cabling, plus missing or illegible CE marking and absent EU contact details. Non-compliant goods were withdrawn, banned and reported on Safety Gate, with online purchases failing more often, signalling intensified RoHS enforcement on low-cost and online products.

    European Commission \u2013 DG GROW (Single Market)
  5. Amendment

    Directive (EU) 2025/2456 in force

    The directive of 26 November 2025 reattributing the scientific and technical tasks of the RoHS Directive to the European Chemicals Agency was published in the Official Journal on 12 December 2025 and entered into force on the twentieth day after publication; its provisions apply from 13 August 2027.

    Source · Art. 2 and Art. 3
  6. Amendment

    Three delegated directives renew the lead exemptions in Annex III

    Commission Delegated Directives (EU) 2025/1802, 2025/2363 and 2025/2364 of 8 September 2025, published on 21 November 2025, entered into force on the twentieth day after publication; they replace Annex III points 7(a), 7(c)-I and 7(c)-II and 6(a) to 6(c) and add points 7(c)-V and 7(c)-VI, with transposition by 30 June 2026 and application from 1 July 2026. The consolidated text of 1 July 2026 incorporates 88 amending acts in total, all but Directive (EU) 2017/2102 being Commission delegated directives adjusting Annexes II, III and IV.

    Source · Art. 1 to Art. 3Source · list of amending acts
  7. Applies

    Phthalate restriction applies to medical devices and monitoring and control instruments

    From this date the restriction of DEHP, BBP, DBP and DIBP applies to medical devices, including in vitro diagnostic devices, and to monitoring and control instruments, including industrial ones; cables and spare parts for such equipment placed on the market before 22 July 2021 remain exempt.

    Source · Annex II
  8. Applies

    Open scope and phthalate restriction apply

    All other electrical and electronic equipment that was outside Directive 2002/95/EC (category 11) placed on the market from this date must comply, and the four phthalates added by Delegated Directive (EU) 2015/863 are restricted in categories 1 to 7, 10 and 11; Member States had also to transpose Directive (EU) 2017/2102 by 12 June 2019.

    Source · Art. 4(3) and Annex IISource · Art. 2
  9. Amendment

    Directive (EU) 2017/2102 in force: scope and spare-part amendments

    The amending directive of 15 November 2017 excludes pipe organs and redefines non-road mobile machinery, removes the bar on secondary-market operations for category 11 equipment, adds cable and spare-part derogations for category 11, allows reused spare parts in closed-loop systems until 2029 and fixes the validity periods of the Annex III exemptions.

    Source · Art. 1 and Art. 3
  10. Amendment

    Delegated Directive (EU) 2015/863 adds four phthalates to Annex II

    The Commission's delegated directive of 31 March 2015 replaced Annex II to add DEHP, BBP, DBP and DIBP at 0,1 % by weight in homogeneous materials, with application from 22 July 2019 and from 22 July 2021 for medical devices and monitoring and control instruments.

    Source · Art. 1, Art. 2, Art. 3 and Annex
  11. Applies

    Directive 2011/65/EU applies; Directive 2002/95/EC repealed

    Member States had to transpose the recast directive and notify their penalty rules by 2 January 2013, and Directive 2002/95/EC with its amending decisions is repealed from 3 January 2013.

    Source · Art. 23, Art. 25 and Art. 26
  12. In force

    Directive 2011/65/EU enters into force

    Adopted on 8 June 2011 as a recast of Directive 2002/95/EC aligned with the New Legislative Framework and published in OJ L 174 on 1 July 2011, the directive entered into force on the twentieth day after publication; Member States had until 2 January 2013 to transpose it.

    Source · Art. 25 and Art. 27

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Questions people ask about RoHS

Which substances does RoHS restrict and at what limits?

Annex II restricts ten substances, measured by weight in each homogeneous material: lead, mercury, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) at 0,1 %, and cadmium at 0,01 %. The four phthalates were added by Delegated Directive (EU) 2015/863 and apply from 22 July 2019, and from 22 July 2021 for medical devices and monitoring and control instruments; DEHP, BBP and DBP in toys are left to REACH entry 51.

Source · Art. 4(1), Art. 4(2) and Annex II
When did RoHS start to apply?

Directive 2011/65/EU entered into force on 21 July 2011, Member States had to transpose it by 2 January 2013 and Directive 2002/95/EC was repealed from 3 January 2013. The scope then widened in steps: medical devices and monitoring and control instruments from 22 July 2014, in vitro diagnostic devices from 22 July 2016, industrial monitoring and control instruments from 22 July 2017 and all other equipment from 22 July 2019.

Source · Art. 4(3), Art. 25, Art. 26 and Art. 27
What is a homogeneous material?

One material of uniform composition throughout, or a material consisting of a combination of materials that cannot be disjointed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes. The maximum concentration values are tolerated per homogeneous material, not per component or product, so a solder joint, a plating layer or a plastic housing is each assessed on its own.

Source · Art. 3(20) and Art. 4(2)
How do RoHS exemptions work and when do they expire?

Annex III lists exemptions for all categories and Annex IV exemptions specific to medical devices and monitoring and control instruments; the Commission adds or deletes entries by delegated act where elimination or substitution is scientifically or technically impracticable, substitutes are unreliable or substitution would do more harm than good. Exemptions run for up to five years for categories 1 to 7, 10 and 11 and up to seven years for categories 8 and 9, and stay valid while a renewal application filed at least 18 months before expiry is pending. The delegated directives of 8 September 2025 renewed the lead exemptions for steel, aluminium and copper alloys, high-melting-temperature solders and glass or ceramic components in narrowed form, with expiries between 11 December 2026 and 31 December 2027. From 13 August 2027 applications go to the European Chemicals Agency.

Source · Art. 4(6), Art. 5 and Annex VSource · AnnexSource · Art. 1 and Art. 2
Which products are outside RoHS?

Article 2(4) excludes equipment for the essential security interests of Member States including arms, munitions and war material, equipment designed to be sent into space, equipment specifically designed to be installed as part of excluded or out-of-scope equipment, large-scale stationary industrial tools, large-scale fixed installations, means of transport for persons or goods other than non-type-approved electric two-wheelers, non-road mobile machinery made available exclusively for professional use, active implantable medical devices, professionally installed photovoltaic panels, business-to-business research and development equipment and pipe organs. Equipment rated above 1 000 V AC or 1 500 V DC is outside the definition of electrical and electronic equipment.

Source · Art. 2(4) and Art. 3(1)
How do I prove RoHS compliance and do I need a notified body?

No notified body is involved. The manufacturer carries out internal production control under Module A of Annex II to Decision No 768/2008/EC, draws up technical documentation, issues the Annex VI EU declaration of conformity and affixes the CE marking to the finished equipment; equipment bearing the CE marking is presumed compliant in the absence of evidence to the contrary, and tests and assessments made in accordance with harmonised standards published in the Official Journal are presumed to demonstrate compliance. Where another Union act requires an equally stringent conformity assessment, RoHS compliance may be shown within that procedure with a single technical documentation.

Source · Art. 7(b), Art. 7(c), Art. 13, Art. 15 and Art. 16
Do spare parts and cables have to comply?

Yes, cables and spare parts for repair, reuse, updating of functionalities or upgrading of capacity must meet the substance limits, with two families of exceptions. Cables and spare parts for equipment placed on the market before the relevant compliance date, 1 July 2006 for the original categories and 22 July 2014, 2016, 2017 or 2019 for the later ones, or for equipment that benefited from a since-expired exemption, are exempt. Reused spare parts recovered from equipment placed on the market before those dates may be used in auditable closed-loop business-to-business return systems, with the reuse notified to the consumer, in equipment placed on the market before 1 July 2016, 22 July 2024, 2026, 2027 or 2029 depending on the category.

Source · Art. 4(1), Art. 4(4) and Art. 4(5)
How long must I keep the technical documentation and traceability records?

Manufacturers keep the technical documentation and the EU declaration of conformity for 10 years after the equipment was placed on the market, authorised representatives keep both at the disposal of the authorities for the same period, and importers keep a copy of the declaration for 10 years and ensure the documentation can be produced. All economic operators must be able to identify who supplied them and whom they supplied for 10 years following the placing on the market, and manufacturers and importers keep a register of non-conforming equipment and recalls.

Source · Art. 7(d), Art. 7(f), Art. 8(b), Art. 9(e), Art. 9(g) and Art. 12

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Related

Related regulations

DetRPOPsREACH

Sources

  1. Directive 2011/65/EU on the restriction of hazardous substances in electrical and electronic equipment, consolidated text of 1 July 2026 (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02011L0065-20260701
  2. Directive 2011/65/EU as published in OJ L 174, 1 July 2011 (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32011L0065
  3. Document information, dates and relationships for CELEX 32011L0065 (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32011L0065
  4. Commission Delegated Directive (EU) 2015/863 adding four phthalates to Annex II (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32015L0863
  5. Directive (EU) 2017/2102 amending Directive 2011/65/EU on scope, spare parts and exemption periods (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017L2102
  6. Commission Delegated Directive (EU) 2025/1802 on lead in high melting temperature solders (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025L1802
  7. Commission Delegated Directive (EU) 2025/2363 on lead in glass or ceramic components (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025L2363
  8. Commission Delegated Directive (EU) 2025/2364 on lead as an alloying element in steel, aluminium and copper (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025L2364
  9. Directive (EU) 2025/2456 reattributing scientific and technical tasks to the European Chemicals Agency (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025L2456
  10. Regulation (EC) No 765/2008 on accreditation and market surveillance (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008R0765
  11. RoHS Directive (European Commission, DG Environment) https://environment.ec.europa.eu/topics/waste-and-recycling/rohs-directive_en
  12. Faktaark: Elektrisk og elektronisk udstyr, RoHS-bekendtgørelsen (Miljøstyrelsen) https://mst.dk/erhverv/sikker-kemi/kemikalier/regler-og-handlingsplaner/faktaark-om-kemikaliereglerne/faktaark-elektrisk-og-elektronisk-udstyr-rohs-bekendtgoerelsen

About this guide

Reviewed by
Conphora compliance team, Compliance editors, Conphora
Reviewed
5 October 2026
Next review
13 March 2027

Written from the official text on EUR-Lex and the Commission’s guidance, with a source for every fact. It is not legal advice.

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Cite this page 
Conphora (2026). RoHS: RoHS Directive (Directive 2011/65/EU), explained. Retrieved 13 October 2026 from https://www.conphora.com/regulations/rohs/
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