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 |
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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 |
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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 |
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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 |
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1a | Lead and cadmium in ion selective electrodes including glass of pH electrodes. | JBCE, JBCE update | JBCE | Download | JBCE |
1b | Lead anodes in electrochemical oxygen sensors. | COCIR, JBCE | COCIR, JBCE | Download | JBCE, ITG |
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 |
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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:
|
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 |
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Others
Expires on 21 July 2021 for the use in medical devices (cat. 8) other than in vitro diagnostic medical devices; |
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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 |
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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:
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JBCE | No clarification required | Download |