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News > EU RoHS Directives and Regulations > EU RoHS Annex IV adds 3 new plasticizer exclusions

EU RoHS Annex IV adds 3 new plasticizer exclusions

2025-07-14

On November 15, 2021, the European Union officially issued Commission Delegated Directive (EU) 2021/1978, (EU) 2021/1979, and (EU) 2021/1980, adding exclusion clauses 45, 46, and 47 to Annex IV of the RoHS Directive (2011/65/EU), stipulating the exemption of plasticizers in medical devices. This addition will take effect from the date of the announcement.

On November 15, 2021, the European Union officially issued Commission Delegated Directives (EU) 2021/1978, (EU) 2021/1979, and (EU) 2021/1980, adding new exclusion clauses 45, 46, and 47 to Annex IV of the RoHS Directive, which exempt phthalates from use in medical devices. This new addition will take effect from the date of the announcement. EU member states must adjust and announce the relevant laws and regulations by April 30, 2022, and the new regulations will be officially implemented on July 21, 2021. The new additions are as follows:

Exemptions		Scope of application and expiration date
45	DEHP in ion-selective electrodes for the analysis of the presence of ionic species in human body fluids and/or dialysate.	Expiration date: July 21, 2028
46	DEHP in plastic components of magnetic resonance imaging (MRI) detector coils.	Expiration date: January 1, 2024
47	DEHP, BBP, DBP, and DIBP in parts recovered from medical devices (including in vitro diagnostic medical devices and their accessories) and used for repair or refurbishment. Used in an auditable, business-to-business, closed-loop system, with consumers informed of the recycled parts.	Expiration date: July 21, 2028

Sources:(EU) 2021/1978, (EU) 2021/1979, (EU) 2021/1980(Please refer to the original text for details)

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