(5)Commission Regulation (EU) No 143/2011note exempted from the authorisation requirement the use of DEHP, BBP and DBP in the immediate packaging of medicinal products covered by Regulation (EC) No 726/2004 of the European Parliament and of the Councilnote, Directive 2001/82/EC of the European Parliament and of the Councilnote and/or Directive 2001/83/EC of the European Parliament and of the Councilnote. The judgment of the Court of Justice of 13 July 2017 in Case C-651/15 P, VECCO and Others v. Commissionnote, provided clarifications on certain aspects of Article 58(2) of Regulation (EC) No 1907/2006 for granting an exemption from the authorisation requirement. The Commission has re-assessed the exemption set out in Annex XIV to that Regulation and has concluded that it does not meet the conditions in Article 58(2). In particular, in the light of that judgement, Regulation (EC) No 726/2004, and Directives 2001/82/EC and 2001/83/EC do not constitute existing specific Union legislation imposing minimum requirements relating to the protection of human health or the environment for the use of DEHP, BBP and DBP in immediate packaging of medicinal products within the meaning of Article 58(2) of Regulation No 1907/2006 since they do not contain provisions specific to those substances imposing such requirements. Furthermore, Regulation (EC) No 726/2004 and Directives 2001/82/EC and 2001/83/EC lay down requirements related to the protection of human health only, while, as regards DEHP, intrinsic properties relating to hazards for the environment have been included in the entry for that substance in Annex XIV to Regulation (EC) No 1907/2006. Those exemptions are therefore not justified and should be deleted.
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