EU - Amending Annex XIV to RoHS Directive Regarding DEHP Usage in Medical Device

​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.

Bis(2-ethylhexyl) phthalate (DEHP) is a restricted substance listed in Annex II to Directive 2011/65/EU, as amended by Commission Delegated Directive (EU) 2015/863. DEHP is not to be used, 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 September 12, 2018 and October 2, 2019, the Commission received applications 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 plastic components in magnetic resonance imaging (MRI) detector coils. There are no suitable alternatives to DEHP sufficiently available on the market and not granting the exemption is likely to result in total negative environmental, health and consumer safety impacts caused by substitution. 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 (46) regarding DEHP in plastic component in MRI detector coils is added to Annex XIV to RoHS Directive with an expiry date January 1, 2024.