Case T‑240/10

Hungary

v

European Commission

(Approximation of laws — Deliberate release of GMOs into the environment — Marketing authorisation procedure — Scientific opinions of EFSA — Comitology — Regulatory procedure — Infringement of essential procedural requirements — Finding of the Court of its own motion)

Summary — Judgment of the General Court (First Chamber, Extended Composition), 13 December 2013

1.      Actions for annulment — Grounds — Infringement of essential procedural requirements — Lack of competence of the institution which adopted the contested measure — To be considered of the Court’s own motion — Condition — Compliance with the principle that the parties should be heard

(Art. 263 TFEU)

2.      Actions for annulment — Grounds — Infringement of essential procedural requirements — Scope — Infringement of procedural rules — Procedure for authorising the marketing of genetically modified organisms — Commission failing to submit amended drafts of authorisation decisions to the competent regulatory committees — Included — Consequence — Invalidity of those authorisation decisions

(Arts 263, second para., TFEU and 264, first para., TFEU; European Parliament and Council Regulation No 1829/2003; European Parliament and Council Directive 2001/18; Council Decision 1999/468, Art. 5)

3.      EU law — Interpretation — Acts of the institutions — Statement of reasons — To be taken into consideration — Decisions based on the opinion of a scientific authority — Incorporation of those opinions into the statement of reasons for such decisions

1.      Infringement of essential procedural requirements within the meaning of Article 263 TFEU constitutes a ground said to be of ‘public policy’, which must be raised by the judicature of the European Union of its own motion. The same goes for lack of competence, within the meaning of that article. In addition, the requirement that the European Union judicature should raise of its own motion a ground involving a question of public policy must be complied with in the light of the rule that the parties should be heard.

(see paras 70, 71)

2.      Non­compliance with a procedural rule constitutes, inter alia, a breach of essential procedural requirements where, if the rule had not been breached, the outcome of the procedure or the content of the adopted act could have been substantially different.

Where the result of an authorisation procedure for marketing genetically modified organisms, or the content of authorisation decisions adopted, could have been substantially different if the Commission had complied with the procedure under Article 5 of Decision 1999/468, the Commission, when it adopts decisions authorising marketing without submitting the amended drafts of those authorisation decisions to the competent regulatory committees for authorisation, infringes its procedural obligations under Article 5 of Decision 1999/468, the provisions of Directive 2001/18 on the deliberate release into the environment of genetically modified organisms and repealing Directive 90/220, and the provisions of Regulation No 1829/2003 on genetically modified food and feed, which refer thereto, and thereby infringes the essential procedural requirements within the meaning of the second paragraph of Article 263 TFEU, which infringement the Court is required to raise of its own motion. Accordingly, such decisions are, in accordance with the first paragraph of Article 264 TFEU, null and void in their entirety.

(see paras 80, 84, 85, 87)

3.      The enacting terms of a measure must be read in the light of the grounds which led to its adoption and with which it is inextricably linked, the measure forming a whole. The institution, in relying in its decisions on the opinions of a scientific authority, incorporates the wording of those opinions in the assessment that underlies the adoption of those decisions and in the statement of reasons on which those decisions were based.

(see paras 90, 91)