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Last updated

RoHS 3 (EU 2015/863)

RoHS 3 (EU Directive 2015/863) adds Category 11 (catch-all) products and adds four new restricted substances - all phthalates. The four phthalates are mainly used as insulation plasticizers, and are on the REACH list of SVHC (Substances of Very High Concern).

Four Substances added

The expanded list for RoHS 3 is thus as follows:

Cadmium (0.01 %)
Lead (0.1 %)
Mercury (0.1 %)
Hexavalent chromium (0.1 %)
Polybrominated biphenyls (PBB) (0.1 %)
Polybrominated diphenyl ethers (PBDE) (0.1 %)

Bis(2-ethylhexyl) phthalate (DEHP) (0.1 %) (NEW)
Butyl benzyl phthalate (BBP) (0.1 %) (NEW)
Dibutyl phthalate (DBP) (0.1 %) (NEW)
Diisobutyl phthalate (DIBP) (0.1 %) (NEW)

Category 11 Added

Category 11 products include all other electronic and electrical equipment not covered under the other categories. Included are 2-wheeled vehicles, electronic nicotine delivery systems (ENDS) such as e-cigarettes, cannabis vaporizers and vape pens. Also included are electrical cables that are less than 250V working voltage.

Category 8 Medical Devices - Exemption Deadlines

Exemptions for Category 8 (medical devices and equipment) are detailed in Annex III and IV. These exemptions allow the use of restricted substances like lead, mercury, cadmium, and hexavalent chromium where substitutes are not yet technically or scientifically feasible. The deadlines for these exemptions have been extended over time through delegated acts, and for Category 8, the extensions are tailored to reflect the complexity of medical device manufacturing and patient safety considerations.

Category 8 covers "medical devices" and "in vitro diagnostic medical devices" (IVDs), with specific timelines established under Article 4 and Annex IV of the RoHS Directive. The key deadline extensions for exemptions relevant to medical devices and equipment under RoHS 3, as of March 15, 2025, are as follows:

1. General Exemptions in Annex III Applicable to Category 8

   • Many exemptions in Annex III (e.g., lead in solders, mercury in lamps) apply across multiple categories, including Category 8. These were initially set to expire on July 21, 2016, for Category 8 under the original RoHS 2 timeline but have been extended through delegated acts.
   • Current Extension: For Category 8 medical devices (excluding IVDs), the expiration date for most Annex III exemptions was extended to July 21, 2021, under Commission Delegated Directives issued between 2014 and 2016 (e.g., 2014/69/EU, 2014/76/EU). However, subsequent renewal applications have pushed this further:
   • Latest Extension: As per updates in 2020–2021 (e.g., Delegated Directive 2021/647), the deadline for many Annex III exemptions applicable to Category 8 medical devices is now July 21, 2026, unless otherwise specified or renewed again. This applies to exemptions like:
     • 7(a): Lead in high melting temperature solders.
     • 7(c)-I: Lead in glass or ceramic materials.
     • 15: Lead in solders for filters and transformers in transducers.
2. 
   

   Category-Specific Exemptions in Annex IV for Medical Devices

   • Annex IV provides exemptions unique to Categories 8 and 9 (industrial monitoring and control instruments). These are tailored to medical devices and IVDs, with extended deadlines reflecting their critical nature.
   • Medical Devices (Excluding IVDs):
     • Original deadline: July 22, 2014 (RoHS 2 entry into force for medical devices).
     • Extended deadline: July 21, 2021, established by Article 4(4)(a) and subsequent delegated acts.
     • Current Extension: Through a series of delegated directives (e.g., 2021/884, 2021/1978), the European Commission extended the validity of Annex IV exemptions for Category 8 medical devices to July 21, 2028. Examples include:
       • Annex IV, Exemption 1: Lead as an alloying element in steel, aluminum, and copper.
       • Annex IV, Exemption 3: Lead in solders for specific medical applications.
       • Annex IV, Exemption 18: Lead in shielding for ionizing radiation (e.g., X-ray equipment).
     • This July 21, 2028 deadline applies unless individual exemptions are revoked or further extended via renewal applications (submitted 18 months prior, i.e., by January 21, 2027).
   • In Vitro Diagnostic Medical Devices (IVDs):
     • Original deadline: July 22, 2016 (RoHS 2 scope expansion).
     • Extended deadline: July 21, 2021, aligned with other Category 8 exemptions.
     • Current Extension: Delegated acts (e.g., 2021/1979) extended Annex IV exemptions for IVDs to July 21, 2026. This shorter timeline compared to other medical devices reflects the phased integration of IVDs into RoHS compliance.

Key Details

• Scope: These extensions apply to both Annex III (general exemptions) and Annex IV (category-specific exemptions) unless an exemption specifies an earlier expiration. For instance, some mercury-related exemptions (e.g., Annex III, Entry 1 for lamps) may have shorter timelines (e.g., July 21, 2025) based on substitute availability.
• Renewal Process: Manufacturers can apply for renewals 18 months before expiration (e.g., by January 2025 for 2026 deadlines). The European Commission, often with input from consultants like the Öko-Institut, evaluates these requests, potentially extending deadlines into the 2030s if justified.
• As of March 15, 2025: No new delegated acts have altered the July 21, 2026 (IVDs) or July 21, 2028 (other medical devices) deadlines since the 2021 updates, but reviews are ongoing, and decisions expected in 2025–2026 could adjust these further.

Summary of Deadlines

• Medical Devices (excluding IVDs): Most Annex III and IV exemptions extended to July 21, 2028.
• In Vitro Diagnostic Medical Devices: Most Annex III and IV exemptions extended to July 21, 2026.

Implications

Manufacturers of Category 8 equipment must verify which exemptions their products rely on, as some may expire earlier (e.g., 2025 or 2026) or be renewed beyond 2028. Compliance requires monitoring EUR-Lex for new delegated acts and preparing for lead-free or alternative-material transitions where exemptions lapse.

For the most precise updates, consult the latest delegated directives published by the European Commission, as timelines may shift with new renewals or technological advancements.