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On July 8, 2026, the European Commission published a draft Delegated Directive proposing amendments to Annexes III and IV of the Restriction of Hazardous Substances (RoHS) Directive (2011/65/EU). The draft outlines updated, time-limited exemptions for the use of lead and cadmium in certain electrical and electronic equipment (EEE). The Commission has opened a public feedback period for the draft act, which will run until August 5, 2026.
Regulatory Context
The RoHS Directive restricts the use of specific hazardous substances, including lead and cadmium electrical and electronic equipment. 10 substances are currently restricted and listed in Annex II to the RoHS Directive: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBBs), polybrominated diphenyl ethers (PBDEs), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP).
Annexes III and IV list the materials and components of EEE for specific applications exempted from the substance restriction in Article 4(1). Under Article 5, exemptions can be granted (or renew) if it does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 (the REACH Regulation), and if the elimination or substitution of these substances is scientifically or technically impracticable, or if the negative impacts of substitution outweigh the benefits.
Following numerous requests from industry stakeholders, the Commission conducted a series of technical and scientific assessments (evaluation packs 19 through 27) between 2020 and 2024 to determine whether existing exemptions should be renewed, modified, or revoked.
Proposed Changes
The proposed regulatory changes impact a wide array of EEE manufacturers, particularly those producing medical devices, industrial monitoring and control instruments (IMCI), and lighting. The categories of EEE covered by the Directive are as follows:
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 monitoring and control instruments.
10. Automatic dispensers.
11. Other EEE not covered by any of the categories above.
Key Amendments in Annex III
Optical and Filter Glass (Point 5b,13a,13b): The exemption for lead (not intentionally added) in soda lime glass used in the glass tube of fluorescent lamps for category 5 have been renewed for 30 months. New sub-points (13(b)-IV to 13(b)-V) include specific applications like infrared interference filters for category 9, with expiration dates set for 30 months after entry into force.
Lamps and Phosphors (Point 18b): Exemptions for lead as an activator in fluorescent powders (e.g., in sun tanning lamps or medical phototherapy equipment, including extracorporeal photopheresis lamps ) have been renewed. Depending on the category, these exemptions will expire in 12 to 54 months.
Soldering and Capacitors (Point 24): Point 24 has been updated to specify lead content in solders for ceramic multilayer capacitors. It differentiates between mechanical mounting (max 50% lead) and high-melting-point processes (min 85% lead), with a general transition period of 18 to 54 months.
Other Components (Point 29, 32,34): Lead in crystal glass, glass frit for laser tubes, and cermet-based trimmer potentiometers also received updated expiration timelines, generally extending for 30 months.
Key Amendments in Annex IV (Medical & Industrial)
Oxygen Sensors (Point 1b): The updates provide detailed sub-points (1(b)-I to 1(b)-VI) for lead and cadmium anodes in various oxygen sensors (e.g., Hersch cells, galvanic sensors). Critical medical consumables and specialized industrial sensors are granted longer transition periods, some up to 78 months.
Lasers (Point 9): Cadmium in helium-cadmium lasers for specific applications, such as Raman spectrometers, is granted a 30-month extension, while general uses expire in 12 months.
Imaging and Superconductors (Point 11): Exemptions for lead in superconducting circuits and thermal conductors used in MRI, NMR are now explicitly set with expiration dates of 12 months after the date of entry.
The complete text for th draft delegated act and its Annex can be accessed here.
