Case T‑204/11

(publication by extracts)

Kingdom of Spain

v

European Commission

(Consumer protection — Regulation (EC) No 15/2011 — Lipophilic toxin detection methods in bivalve molluscs — Replacement of the mouse bioassay with a liquid chromatography-mass spectrometry (LC-MS/MS) method –Article 168 TFEU — Proportionality — Legitimate expectations)

Summary — Judgment of the General Court (Fourth Chamber), 11 February 2015

1.      Public health — Implementing measures — Discretion of the EU institutions — Commission regulation requiring a complex assessment — Judicial review — Limits — Manifest error of assessment or misuse of powers — Need to adduce evidence capable of rendering the assessments made in that measure implausible

(Commission Regulation No 15/2011)

2.      Actions for annulment — Commission regulation requiring a complex assessment — Judicial review — Limits — Assessment of legality by reference to the information available at the time the decision adopted

(Art. 263 TFEU)

3.      Public health — Assessment of risks — Assessment of the scientific methods for assessing various substances — Application of the principles of excellence, transparency and independence

(Commission Regulation No 15/2011)

4.      Public health — Implementing measures — Lipophilic toxin detection methods in bivalve molluscs — Regulation No 15/2011 — Protection of public health outweighing negative economic consequences, even if substantial

(Commission Regulation No 15/2011)

1.      The institutions of the European Union enjoy a wide discretion in the implementation of measures to be taken for the protection of public health, particularly as regards the definition of the objectives to be pursued and choice of the appropriate means of action. That wide discretion implies a limited power of review on the part of the EU judicature, with the effect that review by the Courts as to the substance is limited to verifying whether the exercise by the institutions of their powers is vitiated by a manifest error of appraisal, whether there has been a misuse of powers, or whether the institutions have manifestly exceeded the limits of their discretion.

In order to establish that an institution committed a manifest error in assessing complex facts so as to justify the annulment of that act, the evidence adduced by the applicant must be sufficient to make the factual assessments used in the act implausible. Subject to that review of plausibility, it is not the Court’s role to substitute its assessment of complex facts for that made by the institution which adopted the decision. However, the limits to review by the Courts of the European Union do not affect their duty to establish whether the evidence relied on is factually accurate, reliable and consistent, whether that evidence contains all the information which must be taken into account in order to assess a complex situation, and whether it is capable of substantiating the conclusions drawn from it.

(see paras 30-33)

2.      See the text of the decision.

(see para. 123)

3.      In the matter of the protection of public health, like in the case of compliance with the precautionary principle, scientific assessment of the methods used to analyse various substances must be made on the basis of scientific opinion based on the principles of excellence, transparency and independence. Those requirements constitute an important procedural safeguard with a view to assuring the scientific impartiality of measures and avoiding the use of those that are arbitrary.

(see para. 131)

4.      Protection of public health takes precedence over economic considerations and may therefore justify adverse economic consequences, even those which are substantial, for certain traders.

(see para. 141)