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Conformi/Knowledge Base/Electronics/RoHS
📱For electronics manufacturers

Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS 2 Directive)

Analysis from 7 June 20260 sourcesConsolidated version of 1 January 2025EUR-Lex Original

Do my electronic products still comply with EU substance restrictions after the 2025 exemption renewals and the upcoming ECHA procedural shift?

Any EEE placed on the EU market must stay below 10 restricted-substance thresholds in every homogeneous material — non-compliance triggers Member State penalties that must be effective and dissuasive [Art. 23], and from 13 August 2027 all exemption and restriction applications route through ECHA instead of the Commission directly [Directive (EU) 2025/2456].

Short Answer

Directive 2011/65/EU (RoHS 2) bans lead, mercury, cadmium, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP and DIBP above defined concentration limits in EEE across all 11 Annex I categories [Art. 4(1), Annex II]. Exemptions in Annexes III and IV are time-limited (5 years for categories 1–7, 10, 11; 7 years for categories 8 and 9) and must be renewed 18 months before expiry [Art. 5(2), Art. 5(5)]. Recent delegated directives (EU) 2023/1526, (EU) 2024/0232, (EU) 2024/1416, (EU) 2025/1802, (EU) 2025/2363, and (EU) 2025/2364 have added or renewed specific Annex III/IV exemptions through to 2028. Directive (EU) 2025/2456 fundamentally restructures Articles 5 and 6 by reattributing scientific evaluation tasks to ECHA and its RAC/SEAC committees, applicable from 13 August 2027.

Who is affected

All manufacturers, importers and distributors placing EEE on the EU/EEA market across all 11 categories of Annex I — including medical devices (cat. 8), monitoring and control instruments (cat. 9), and the catch-all category 11. Exclusions are narrow: military equipment, spacecraft, large-scale fixed installations, means of transport, pipe organs, and a few other specifically listed items [Art. 2(4)].

Deadline

Ongoing permanent obligation for every product placed on the market. Next structural change: 13 August 2027 (application date of Directive (EU) 2025/2456 — exemption and restriction processes shift to ECHA). Individual Annex III/IV exemptions carry case-specific expiry dates, many cluster around 2025–2028.

Risk

Penalties are set by Member States and must be effective, proportionate and dissuasive; they may include criminal sanctions for serious infringements [Art. 23, Art. 15(3)]. Non-compliant EEE must be withdrawn or recalled. In practice, market surveillance authorities (e.g. Germany's Marktüberwachungsbehörden) impose sales bans and fines typically in the range of EUR 10 000–100 000 per product line depending on jurisdiction.

Proof

Legal status

  • • In force
  • • as of 2026-06-07
  • • Consolidated version of 1 January 2025

Primary sources

    What to do now

    Legal / DPO

    • •Audit all current Annex III/IV exemptions your product lines rely on — verify each exemption's expiry date against the latest delegated directives (2023/1526, 2024/0232, 2024/1416, 2025/1802, 2025/2363, 2025/2364) and file renewal applications at least 18 months before expiry [Art. 5(5)].
    • •Prepare for the ECHA procedural shift effective 13 August 2027: future exemption applications must be submitted to ECHA (not the Commission) and will be evaluated by RAC/SEAC committees [Art. 5(3) as amended by Directive (EU) 2025/2456].
    • •Maintain the EU Declaration of Conformity and technical documentation for 10 years after placing on the market, and ensure the internal production control procedure demonstrates substance compliance [Art. 7(c), Art. 13].

    Compliance

    • •Implement a homogeneous-material testing regime covering all 10 restricted substances at Annex II thresholds (0.1% for most; 0.01% for cadmium) across every product variant, including cables and spare parts [Art. 4(1), Annex II].
    • •Track category-specific phase-in dates for the four phthalates (DEHP, BBP, DBP, DIBP): restriction applies to medical devices and monitoring/control instruments from 22 July 2021, with spare-part derogation for equipment placed on market before that date [Annex II].
    • •Register non-conforming EEE, maintain a recall register, and ensure distributors are informed of any non-conformity detected post-market [Art. 7(f), Art. 9(e)].

    IT / Security

    • •Ensure traceability data (type, batch, serial number) is embedded in or accompanies every EEE unit to support market surveillance requests within the 10-year retention window [Art. 7(g), Art. 12].
    • •Integrate substance-compliance documentation into your product lifecycle management system so that material declarations per homogeneous material are retrievable on authority request [Art. 7(i)].
    • •Assess whether any industrial monitoring and control instruments (category 9) in your IT infrastructure rely on expiring Annex IV exemptions — particularly mercury-containing pressure transducers (exemption 49, expires 31 December 2025 per Directive (EU) 2023/1437) [Annex IV].

    Product / Engineering

    • •Design out restricted substances at BOM level — target lead-free soldering, halogen-free flame retardants, and phthalate-free plasticisers to avoid reliance on time-limited exemptions that may not be renewed [Art. 4(1), Art. 5(1)(a)].
    • •For category 11 products using recovered PVC: comply with the new Annex III entry 46 conditions — from 28 May 2026, recovered rigid PVC from EE windows/doors may only be reused for articles under REACH Annex XVII entry 63, points 18(a)–(d) [Directive (EU) 2024/232].
    • •Affix CE marking only after completing the internal production control procedure (Module A of Decision 768/2008/EC) and verifying all Annex II substance limits are met in the finished product [Art. 7(b), Art. 7(c), Art. 14].

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    Key Terms

    EEE (Electrical and Electronic Equipment)
    Equipment dependent on electric currents or electromagnetic fields to work properly, or equipment for generation, transfer and measurement of such currents/fields, rated up to 1 000 V AC / 1 500 V DC [Art. 3(1)].
    Homogeneous material
    A material that cannot be mechanically disjointed into different materials — the unit of measurement for substance concentration limits under Annex II.
    Maximum concentration value
    The highest permissible weight percentage of a restricted substance in any single homogeneous material (e.g. 0.1% for lead, 0.01% for cadmium) [Art. 4(2), Annex II].
    Delegated act (delegated directive)
    A legislative instrument adopted by the Commission under powers conferred by the co-legislators to amend non-essential elements of a directive, such as updating Annex III/IV exemptions [Art. 20].
    CE marking
    The conformity marking affixed to EEE after the manufacturer demonstrates compliance with Art. 4 requirements via internal production control (Module A), subject to the general principles of Regulation (EC) No 765/2008 [Art. 14, Art. 15].
    ECHA (European Chemicals Agency)
    The EU agency that, from 13 August 2027, will evaluate exemption applications and prepare restriction dossiers under the amended Arts. 5 and 6 of Directive 2011/65/EU [Directive (EU) 2025/2456].
    Restriction dossier
    A formal document prepared by ECHA (at Commission request) or by a Member State to propose adding a substance to the restricted list in Annex II, subject to RAC/SEAC committee opinions [Art. 6(2) as amended by Directive (EU) 2025/2456].
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    Frequently Asked Questions

    Which substances are restricted under RoHS 2 and at what concentration limits?
    Annex II restricts 10 substances: lead (0.1%), mercury (0.1%), cadmium (0.01%), hexavalent chromium (0.1%), PBB (0.1%), PBDE (0.1%), DEHP (0.1%), BBP (0.1%), DBP (0.1%), and DIBP (0.1%) — all measured by weight in homogeneous materials [Art. 4(1), Annex II].
    What EEE categories fall within scope?
    All 11 categories of Annex I: large and small household appliances, IT/telecom equipment, consumer equipment, lighting, electrical tools, toys/leisure/sports, medical devices, monitoring and control instruments (incl. industrial), automatic dispensers, and all other EEE not covered above [Art. 2(1), Annex I].
    How do exemptions work and how long are they valid?
    Exemptions are granted via delegated acts when substitution is scientifically or technically impracticable, or when the substitute's reliability is unproven, or when total negative environmental impacts of substitution outweigh the benefits. Validity: up to 5 years for categories 1–7, 10 and 11; up to 7 years for categories 8 and 9. Renewal must be applied for at least 18 months before expiry [Art. 5(1)(a), Art. 5(2), Art. 5(5)].
    What changes does Directive (EU) 2025/2456 bring?
    From 13 August 2027, exemption applications under Art. 5 must be submitted to ECHA rather than the Commission. ECHA's Committee for Socioeconomic Analysis (and where appropriate, Committee for Risk Assessment) will evaluate applications. The substance restriction process under Art. 6 is similarly reattributed to ECHA, with a new formal restriction dossier procedure (new Art. 6a, 6b) and mandatory periodic review at least every 4 years [Directive (EU) 2025/2456, Art. 1].
    What are the penalties for non-compliance?
    Member States set penalties, which must be effective, proportionate and dissuasive, and may include criminal sanctions for serious infringements such as improper use of the CE marking [Art. 23, Art. 15(3)]. In addition, non-compliant products face market withdrawal and recall obligations [Art. 7(h), Art. 9(f)].
    Does RoHS 2 apply to spare parts and cables?
    Yes. Art. 4(1) explicitly covers cables and spare parts for repair, reuse, updating of functionalities, or upgrading of capacity. However, spare parts for EEE placed on the market before the phthalate restriction dates benefit from a time-limited derogation [Art. 4(1), Annex II].
    What documentation must manufacturers maintain?
    Manufacturers must draw up technical documentation demonstrating conformity with Art. 4 substance requirements, issue an EU Declaration of Conformity, affix CE marking, and retain all documentation for 10 years after placing EEE on the market [Art. 7(b), Art. 7(c), Art. 7(d)].
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