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Document Ares(2023)324550
RoHS exemption for lead in polyvinyl chloride for sensors used in diagnostic medical devices
COMMISSION DELEGATED DIRECTIVE (EU) .../… amending Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabilizer in polyvinyl chloride used as base material in sensors used in in-vitro diagnostic medical devices
- Legal basis:
- 32011L0065 - A05P1PTA)
- Initiative summary:
- Certain hazardous substances are restricted in electrical and electronic equipment (EEE) under the RoHS Directive. Specific, time-limited exemptions can be granted upon request from economic operators if the necessary criteria are met. This exemption under assessment concerns lead in polyvinyl chloride (PVC) used as base material in sensors which are used in in-vitro diagnostic medical devices.
- EuroVoc thesaurus:
- EU environmental policy; market approval; marketing standard; medical device; dangerous substance; electronic equipment; physical process; lead; plastics
- See the lifecycle of this act on the Interinstitutional register of delegated acts
-
- Leading service:
- Directorate-General for Environment
- Expert group:
- E02810
- Planned adoption period:
- 01/10/2022 - 31/12/2022
- Check the status of this initiative on the Better Regulation Portal
-
- Documents:
- Ares(2023)324550 (Draft delegated directive)
- Legal basis:
- 32011L0065 - A05P1PTA)
- Leading service:
- Directorate-General for Environment
- Expert group:
- E02810
- Check the status of this initiative on the Better Regulation Portal
-
- Consultation type:
- Stakeholder feedback
- Consultation duration (weeks):
- 4
-
- Documents:
- C/2023/3138 final (Delegated directive)
- Leading service:
- Directorate-General for Environment
-
- Foreseen end of objection period:
- 16/07/2023
-
- Documents:
- 32023L1526 (Delegated directive)
- Date of publication:
- 24/07/2023