(3)Pursuant to Commission Delegated Directive (EU) 2015/863note, 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 22 July 2021, in medical devices, including in vitro medical devices above a maximum concentration value of 0,1% tolerated by weight in homogeneous materials.