178However, it should be borne in mind that it is for the applicant to prove that the conditions of approval are met in order to obtain the approval of an active substance, and not for the Commission to prove that the conditions of approval are not met in order to be able to refuse it (see, to that effect and by analogy, judgment of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraphs 86 and 88). In view of that allocation of the burden of proof, where an applicant considers that new data or studies, submitted after his or her dossier has been validated, should have been taken into account for the evaluation of the substance at issue, it is for that applicant to demonstrate that such data or studies could not be submitted before his or her dossier was validated, that they are necessary and that they manifestly call into question the outcome of the evaluation procedure.
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