Judgment_paragraph 65 · TestBioTech eV and Others v European Commission (C-82/17 P)

65The first part of the second ground of appeal relates to paragraphs 67, 83 and 88 of the judgment under appeal, which are worded as follows:67 In order to state the grounds for conducting the review in the manner required, a party requesting the internal review of an administrative act under environmental law is required to put forward any facts or legal arguments raising serious doubts about the assessment made in that act by the EU institution or body. As acknowledged by the Commission in its rejoinder and at the hearing, a third party challenging a marketing authorisation must adduce substantial evidence liable to raise serious doubts as to the lawfulness of the grant of that authorisation (see, to that effect, and by analogy, judgment of 21 May 2015, Schräder v CPVO, C‑546/12 P, EU:C:2015:332, paragraph 57)....83 As held in paragraph 67 above, in order to state the grounds for conducting the review in the manner required, a party requesting the internal review of an administrative act under environmental law is required to put forward any facts or legal arguments raising serious doubts about the assessment made in that act by the EU institution or body. As acknowledged by the Commission in its rejoinder and at the hearing, a third party challenging a marketing authorisation must adduce substantial evidence liable to raise serious doubts as to the lawfulness of the grant of that authorisation....88 Therefore, and contrary to the Commission’s assertions in the … decision [at issue], the first applicant cannot be required “[to] prove that the [authorisation] decision is in breach of Regulation (EC) No 1829/2003”; rather, it must provide a set of material raising serious doubts as to the lawfulness of the authorisation decision.’