Exemption Requests

The objective of this contract is to provide a clear technical and scientific assessment for the following sixteen exemption requests of Annex IV to Directive 2011/65/EU (RoHS) in agreement with the Commission.

No. Exemption wording Request(s) Clarification Questionnaire(s) Consultation Questionnaire Consultation Responses
Equipment utilising or detecting ionising radiation
Expiry due to Art. 4(3) in combination with Art. 5(2)(b): maximum 7 year validity period will reach in 2021 for medical devices (cat. 8) other than in-vitro diagnostics and monitoring and control instruments (cat. 9) other than industrial monitoring and control instruments
1 Lead, cadmium and mercury in detectors for ionising radiation COCIR, JBCE COCIR, JBCE Download
2 Lead bearings in X-ray tubes. COCIR COCIR Download
3 Lead in electromagnetic radiation amplification devices: micro-channel plate and capillary plate. JBCE No clarification required Download Photonis
5 Lead in shielding for ionising radiation COCIR-JBCE-TMC, JBCE-TMC additional information, COCIR LCA assessment, COCIR LCA presentation COCIR-JBCE-TMC, JBCE Download
No. Exemption wording Request(s) Clarification Questionnaire(s) Consultation Questionnaire Consultation Responses
Sensors, detectors and electrodes
Expiry due to Art. 4(3) in combination with Art. 5(2)(b): maximum 7 year validity period will reach in 2021 for medical devices (cat. 8) other than in-vitro diagnostics and monitoring and control instruments (cat. 9) other than industrial monitoring and control instruments
1a Lead and cadmium in ion selective electrodes including glass of pH electrodes. JBCE, JBCE update JBCE Download
1b Lead anodes in electrochemical oxygen sensors. COCIR, JBCE COCIR, JBCE Download JBCE
1c Lead, cadmium and mercury in infra-red light detectors. COCIR, JBCE, LC, PE, PPTF COCIR, JBCE, LC, PE, PPTF Download Berghof, T&B Electronics, Dragerwerk, ffe, voestalpine, trinamix, JBCE, Siemens
No. Exemption wording Request(s) Clarification Questionnaire(s) Consultation Questionnaire Consultation Responses
Others
Expiry due to Art. 4(3) in combination with Art. 5(2)(b): maximum 7 year validity period will reach in 2021 for medical devices (cat. 8) other than in-vitro diagnostics and monitoring and control instruments (cat. 9) other than industrial monitoring and control instruments
11 Lead in alloys as a superconductor and thermal conductor in MRI. COCIR COCIR Download
13 Lead in counterweights. COCIR COCIR Download
14 Lead in single crystal piezoelectric materials for ultrasonic transducers. COCIR COCIR Download
15 Lead in solders for bonding to ultrasonic transducers. COCIR-JBCE COCIR-JBCE Download
17 Lead in solders in portable emergency defibrillators. COCIR, User Manual COCIR Download
No. Exemption wording Request(s) Clarification Questionnaire(s) Consultation Questionnaire Consultation Responses
Others
Expiry on 30 June 2021 for medical devices (cat. 8) other than in-vitro diagnostics and monitoring and control instruments (cat. 9) other than industrial monitoring and control instruments
26 Lead in the following applications that are used durably at a temperature below – 20 °C under normal operating and storage conditions:
  1. solders on printed circuit boards;
  2. termination coatings of electrical and electronic components and coatings of printed circuit boards;
  3. solders for connecting wires and cables;
  4. solders connecting transducers and sensors. Lead in solders of electrical connections to temperature measurement sensors in devices which are designed to be used periodically at temperatures below – 150 °C.
COCIR, Lakeshore COCIR Download
29 Lead in alloys, as a superconductor or thermal conductor, used in cryo-cooler cold heads and/or in cryo-cooled cold probes and/or in cryo-cooled equipotential bonding systems, in medical devices (category 8) and/or in industrial monitoring and control instruments. COCIR COCIR Download
No. Exemption wording Request(s) Clarification Questionnaire(s) Consultation Questionnaire Consultation Responses
Others
Expires on 21 July 2021 for the use in medical devices (cat. 8) other than in vitro diagnostic medical devices;
31a Lead, cadmium, hexavalent chromium, and polybrominated diphenyl ethers (PBDE) in spare parts recovered from and used for the repair or refurbishment of medical devices, including in vitro diagnostic medical devices, or electron microscopes and their accessories, provided that the reuse takes place in auditable closed-loop business-to-business return systems and that each reuse of parts is notified to the customer. COCIR, COCIR LCA assessment COCIR Download
No. Exemption wording Request(s) Clarification Questionnaire(s) Consultation Questionnaire Consultation Responses
Others
Expires on 21 July 2021 for medical devices (cat. 8) other than in vitro diagnostic medical devices and industrial monitoring and control instruments (cat. 9)
39 Lead in micro-channel plates (MCPs) used in equipment where at least one of the following properties is present:
  1. a compact size of the detector for electrons or ions, where the space for the detector is limited to a maximum of 3 mm/MCP (detector thickness + space for installation of the MCP), a maximum of 6 mm in total, and an alternative design yielding more space for the detector is scientifically and technically impracticable;
  2. a two-dimensional spatial resolution for detecting electrons or ions, where at least one of the following applies:
    1. a response time shorter than 25 ns;
    2. a sample detection area larger than 149 mm2;
    3. a multiplication factor larger than 1,3 × 103.
  3. a response time shorter than 5 ns for detecting electrons or ions;
  4. a sample detection area larger than 314 mm2 for detecting electrons or ions;
  5. a multiplication factor larger than 4,0 × 107.
JBCE No clarification required Download