EU - Amending Annex XIV to RoHS Directive Regarding the Use of DEHP in Ion-selective Electrodes

​Directive 2011/65/EU requires Member States to ensure that electrical and electronic equipment placed on the market does not contain the hazardous substances listed in Annex II to the Directive. That restriction does not apply to certain exempted applications listed in Annex IV to the Directive.

Pursuant to Commission Delegated Directive (EU) 2015/863, bis(2-ethylhexyl) phthalate (DEHP) is a restricted substance listed in Annex II to Directive 2011/65/EU and its use is to be prohibited, from July 22, 2021, in medical devices, including in-vitro medical devices above a maximum concentration value of 0,1% tolerated by weight in homogeneous materials.

On July 17, 2018, the Commission received an application made in accordance with Article 5(3) of Directive 2011/65/EU for an exemption to be listed in Annex IV to that Directive, for the use of DEHP in ion-selective electrodes for analyzing human body fluids and/or in dialysate fluids.

There are no reliable alternatives to DEHP sufficiently on the market and the substitution of DEHP in such applications would result in negative environmental and health impacts that outweigh its benefits. Furthermore, the exemption is consistent with REACH Regulation and thus does not weaken the environmental and health protection afforded by it.

Therefore, a new exemption entry (45) regarding the use of DEHP in ion-selective electrodes applied in point of care analysis of ionic substances present in human body fluids and/or in dialysate fluids is added to Annex XIV to RoHS Directive with an expiry date July 21, 2028.