RoHS exemptions

RoHS Annex IV exemption 45: Bis(2-ethylhexyl) phthalate (DEHP) in ion-selective electrodes applied in point of care analysis of ionic...

Source: Directive 2011/65/EU (RoHS), consolidated textRetrieved 2026-11-05Independent information site: we are not the authority and not the source of the data.

Annex IV 45 covers: Bis(2-ethylhexyl) phthalate (DEHP) in ion-selective electrodes applied in point of care analysis of ionic substances present in human body fluids and/or in dialysate fluids. The annex states an expiry date of 21 July 2028.

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Annex
Annex IV: Applications exempted from the restriction in Article 4(1) specific to medical devices and monitoring and control instruments
Entry
45
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) in ion-selective electrodes applied in point of care analysis of ionic substances present in human body fluids and/or in dialysate fluids

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.

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