Monsanto SAS and Others v Ministre de l'Agriculture et de la Pêche.
Date: 2011-09-08
40. Under Article 16(1) of Directive 2002/53, Member States are required to ensure that, with effect from their inclusion in the common catalogue of varieties of agricultural plant species, provided for in Article 17 thereof, seeds of varieties accepted in accordance with that directive or in accordance with principles corresponding to those of that directive are not made subject to any marketing restrictions relating to variety, save as provided for in Articles 16(2) or 18 of Directive 2002/53 (see, to that effect, Case C‑165/08 Commission  v Poland  [2009] ECR I‑6843, paragraph 62).
66. In that regard, it must be held that, as is evidenced by the wording of Article 34 of Regulation No 1829/2003, that provision, first, lays down the substantive conditions under which a product authorised by that regulation or in accordance therewith may be the subject of emergency measures and, second, refers, as regards the conditions for adopting those measures, to the ‘procedures provided for in Articles 53 and 54 of Regulation [No 178/2002]’.
67. Thus, Article 34 of Regulation No 1829/2003 does not make the adoption of emergency measures subject to the substantive conditions provided for in Article 53 of Regulation No 178/2002.
68. It should also be noted that Article 53 of Regulation No 178/2002 concerns emergency measures which may be taken by the Commission, with the adoption of such measures by the Member States coming under Article 54 of that regulation.
69. Consequently, a Member State wishing to adopt emergency measures pursuant to Article 34 of Regulation No 1829/2003 must comply, not only with the substantive conditions laid down in that article, but also with the procedural conditions provided for in Article 54 of Regulation No 178/2002.
71. Those conditions must be interpreted not only in the light of the wording of that provision, but also in the light of the purpose of Regulation No 1829/2003 and the precautionary principle, in order to ensure a high level of protection of human life and health, whilst taking care to ensure the free movement of safe and wholesome food and feed, which is an essential aspect of the internal market (see, by analogy, Case C‑6/99 Greenpeace France and Others  [2000] ECR I‑1651, paragraph 44, and Case C‑236/01 Monsanto Agricoltura Italia and Others [2003] ECR I‑8105, paragraph 110).
73. Accordingly, in the light of the urgent nature of the intervention of the Member State concerned and the objective of public-health protection pursued by Regulation No 1829/2003, Article 54(1) of Regulation No 178/2002 must be interpreted as requiring, in the same way as, moreover, under Article 23 of Directive 2001/18, that, in the event of an emergency, the Commission be informed no later than the time at which the emergency measures are adopted by the Member State concerned.
77. Protective measures adopted under Article 34 of Regulation No 1829/2003 cannot validly be based on a purely hypothetical approach to the risk, founded on mere assumptions which have not yet been scientifically verified. On the contrary, such protective measures, notwithstanding their temporary character 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 an individual case, which indicate that those measures are necessary (see, to that effect, Monsanto Agricoltura Italia and Others , cited above, paragraphs 106 and 107).
79. It follows that, at the stage of adoption and implementation by the Member States of the emergency measures referred to in Article 34 of Regulation No 1829/2003, as long as no decision has been adopted in that regard at European Union level, the national courts before which actions have been brought to test the lawfulness of such measures have jurisdiction to assess the lawfulness of those measures having regard to the substantive conditions provided for in Article 34 of Regulation No 1829/2003 and the procedural conditions laid down in Article 54 of Regulation No 178/2002, whilst the uniformity of European Union law may be ensured by the Court of Justice under the preliminary-ruling procedure since, if a national court has doubts as to the interpretation of a provision of European Union law, it may, or must, in accordance with the second and third paragraphs of Article 267 TFEU, refer a question to the Court of Justice for a preliminary ruling (see, by analogy, Case C‑375/07 Heuschen & Schrouff Oriëntal Foods Trading  [2008] ECR I‑8691, paragraphs 63 and 67).
80. However, where, in one case, the Commission has referred a matter to the Standing Committee on the Food Chain and Animal Health and a decision has been adopted at European Union level, the factual and legal assessments relating to that case and contained in such a decision are binding on all bodies of the Member State which is the addressee of such a decision, in accordance with Article 288 TFEU, including its courts which are called on to assess the lawfulness of measures adopted at national level (see, by analogy, Heuschen & Schrouff Oriëntal Foods Trading , cited above, paragraph 64).