RoHS Annex IV exemption 47: Bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl...
Annex IV 47 covers: Bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical... The annex states an expiry date of 21 July 2028.
- Annex
- Annex IV: Applications exempted from the restriction in Article 4(1) specific to medical devices and monitoring and control instruments
- Entry
- 47
- Section of the annex
- Others
- Expiry in the annex
- Expiry date stated in the annex: 21 July 2028
- Version
- Consolidated version of 1 July 2026
- Official source
- Directive 2011/65/EU (RoHS), consolidated text
Entry (official wording)
Bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices, including in vitro diagnostic medical devices, 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.
Expires on 21 July 2028.
Date wording in the entry
Expires on 21 July 2028.
Validity and renewal
Article 5(5) of the directive: "An application for renewal of an exemption shall be made no later than 18 months before the exemption expires. The existing exemption shall remain valid until a decision on the renewal application is taken by the Commission." This site does not show whether a renewal application for this entry is pending or decided.
Article 5 of the directive sets validity periods and the renewal procedure for exemptions in Annexes III and IV. Its wording is quoted on the Sources and method page. This page repeats only what the annex says about this entry.
Neighbouring entries in Annex IV
- Annex IV 44: Cadmium in radiation tolerant video camera tubes designed for cameras with a...
- Annex IV 45: Bis(2-ethylhexyl) phthalate (DEHP) in ion-selective electrodes applied in...
- Annex IV 46: Bis(2-ethylhexyl) phthalate (DEHP) in plastic components in MRI detector coils.
- Annex IV 48: Lead in bismuth strontium calcium copper oxide (BSCCO) superconductor cables...
- Annex IV 49: Mercury in melt pressure transducers for capillary rheometers at...
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