Judgment_paragraph 51 · Criminal proceedings against Giorgio Fidenato and Others (C-111/16)

51On this point, the Court held, in paragraphs 76 and 77 of its judgment of 8 September 2011, Monsanto and Others (C‑58/10 to C‑68/10, EU:C:2011:553), that the terms ‘evidently’ and ‘serious risk’ within the meaning of Article 34 of Regulation No 1829/2003 must be understood as referring to a significant risk which clearly jeopardises human health, animal health or the environment. That risk must be established on the basis of new evidence based on reliable scientific data. Protective measures adopted under Article 34 of Regulation No 1829/2003 cannot validly be explained on a purely hypothetical approach to the risk based on mere assumptions which have not yet been scientifically verified. On the contrary, such protective measures, notwithstanding their temporary nature and even if they are preventive in nature, may be adopted only if they are based on a risk assessment which is as complete as possible in the particular circumstances of the individual case, which indicate that those measures are necessary.