Case C-601/11 P

French Republic

v

European Commission

‛Appeal — Action for annulment — Protection against transmissible spongiform encephalopathies — Regulation (EC) No 746/2008 — Regulation authorising less restrictive measures of surveillance and eradication than those previously laid down — Precautionary principle — Level of protection of human health — New elements capable of altering the perception of the risk — Failure to state reasons — Distortion of the facts — Error of law’

Summary — Judgment of the Court (Fourth Chamber), 11 July 2013

1. Appeals — Grounds — Mere repetition of the pleas and arguments put forward before the General Court— Inadmissibility — Challenge to the interpretation or application of Community law made by the General Court — Admissibility

   (Art. 256(1), second para., TFEU; Statute of the Court of Justice, Art. 58)

2. Appeals — Grounds — Inadequate statement of reasons — Reliance by the General Court on implied reasoning — Lawfulness — Conditions

   (Art. 256(1), second para., TFEU; Statute of the Court of Justice, Arts 36 and 53, first para.; Rules of Procedure of the General Court, Art. 81)

3. Acts of the institutions — Proportionate nature — Criteria for assessment —Assessment of the elements available when the measure was adopted — Legislation for the protection of public health — Application of the precautionary principle and the principle that preventive action should be taken — New elements coming to light — Obligation to adapt that legislation

4. Appeals — Grounds — Review by the Court of the legal classification of the facts — Lawfulness

   (Art. 256 TFEU)

5. Agriculture — Approximation of laws on animal health —Protection measures with regard to transmissible spongiform encephalopathies — Adoption on the basis of a scientific assessment of the risks — Relaxation of earlier preventative measures — Lawfulness — Condition — Maintenance of the level of protection of human health

   (European Parliament and Council Regulations No 999/2001, Arts 24 and 24(a), No 178/2002, Art. 7(2) and No 1923/2006)

6. Agriculture — Common agricultural policy — Implementation — Scientific assessment of the risks — Determination of the level of risk — Discretion of the Commission — Judicial review — Limits

   (Art. 168(1) TFEU)

7. Appeals — Grounds — Plea submitted for the first time in the context of the appeal — Inadmissibility

   (Art. 256(1), second para., TFEU; Statute of the Court of Justice, Art. 58)

1.  See the text of the decision.

   (see paras 70-72, 141)

2.  See the text of the decision.

   (see paras 82, 83)

3.  See the text of the decision.

   (see para. 110)

4.  See the text of the decision.

   (see para. 119)

5.  When adopting protection measures with regard to transmissible spongiform encephalopathies under Regulation No 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies, according to Article 24a of that regulation, which was inserted by Regulation No 1923/2006, the decisions to be adopted in accordance with one of the procedures referred to in Article 24 of Regulation No 999/2001 are to be based on an appropriate assessment of the possible risks for human and animal health and shall, taking into account existing scientific evidence, maintain, or if scientifically justified increase, the level of protection of human and animal health ensured in the Union.

   In that regard, even though the recitals of the preamble to Regulation No 1923/2006 do not contain any explanation as to the purpose of the proposal concerned, it is clear from those travaux préparatoires that Article 24a of Regulation No 999/2001 was envisaged as a guarantee aimed at preventing measures which lower the level of protection of human and animal health in the European Union from being adopted under the comitology procedure. It does not, however, follow that Article 24a of Regulation No 999/2001 excludes any relaxation of the earlier preventive measures. First of all, Article 24a of Regulation No 999/2001 does not lay down as a yardstick the fact that the comparison must be carried out with respect to the level of protection resulting from the earlier preventive measures adopted in the same field, but refers in general to the level of health assured in the Union. Second, it follows from both Article 7(2) of Regulation No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety and the Court’s case-law that the provisional risk management measures, which are adopted in the context of scientific uncertainty, must be re-examined within a reasonable amount of time in order to ensure that they are proportionate and no more restrictive of trade than is required to achieve the high level of health protection chosen by the Union.

   Therefore, the level of protection of human health is tightly correlated to the level of risk deemed acceptable for society, which depends, in turn, on the scientific knowledge available at a given moment. It cannot be ruled out that, in the light of scientific progress, the same level of protection may be ensured by less restrictive measures.

   (see paras 131-136)

6.  As regards the assessment of the risks to human health, since the determination of the level of risk deemed acceptable falls within the sphere in which the Commission is called on to undertake complex assessments and enjoys broad discretion, judicial review of the exercise of its powers must be limited to examining whether it is vitiated by a manifest error of assessment or whether the legislature has manifestly exceeded the limits of its discretion.

   (see paras 142, 143)

7.  See the text of the decision.

   (see para. 149)

Case C-601/11 P

French Republic

v

European Commission

‛Appeal — Action for annulment — Protection against transmissible spongiform encephalopathies — Regulation (EC) No 746/2008 — Regulation authorising less restrictive measures of surveillance and eradication than those previously laid down — Precautionary principle — Level of protection of human health — New elements capable of altering the perception of the risk — Failure to state reasons — Distortion of the facts — Error of law’

Summary — Judgment of the Court (Fourth Chamber), 11 July 2013

1. Appeals — Grounds — Mere repetition of the pleas and arguments put forward before the General Court— Inadmissibility — Challenge to the interpretation or application of Community law made by the General Court — Admissibility

   (Art. 256(1), second para., TFEU; Statute of the Court of Justice, Art. 58)

2. Appeals — Grounds — Inadequate statement of reasons — Reliance by the General Court on implied reasoning — Lawfulness — Conditions

   (Art. 256(1), second para., TFEU; Statute of the Court of Justice, Arts 36 and 53, first para.; Rules of Procedure of the General Court, Art. 81)

3. Acts of the institutions — Proportionate nature — Criteria for assessment —Assessment of the elements available when the measure was adopted — Legislation for the protection of public health — Application of the precautionary principle and the principle that preventive action should be taken — New elements coming to light — Obligation to adapt that legislation

4. Appeals — Grounds — Review by the Court of the legal classification of the facts — Lawfulness

   (Art. 256 TFEU)

5. Agriculture — Approximation of laws on animal health —Protection measures with regard to transmissible spongiform encephalopathies — Adoption on the basis of a scientific assessment of the risks — Relaxation of earlier preventative measures — Lawfulness — Condition — Maintenance of the level of protection of human health

   (European Parliament and Council Regulations No 999/2001, Arts 24 and 24(a), No 178/2002, Art. 7(2) and No 1923/2006)

6. Agriculture — Common agricultural policy — Implementation — Scientific assessment of the risks — Determination of the level of risk — Discretion of the Commission — Judicial review — Limits

   (Art. 168(1) TFEU)

7. Appeals — Grounds — Plea submitted for the first time in the context of the appeal — Inadmissibility

   (Art. 256(1), second para., TFEU; Statute of the Court of Justice, Art. 58)

1.  See the text of the decision.

   (see paras 70-72, 141)

2.  See the text of the decision.

   (see paras 82, 83)

3.  See the text of the decision.

   (see para. 110)

4.  See the text of the decision.

   (see para. 119)

5.  When adopting protection measures with regard to transmissible spongiform encephalopathies under Regulation No 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies, according to Article 24a of that regulation, which was inserted by Regulation No 1923/2006, the decisions to be adopted in accordance with one of the procedures referred to in Article 24 of Regulation No 999/2001 are to be based on an appropriate assessment of the possible risks for human and animal health and shall, taking into account existing scientific evidence, maintain, or if scientifically justified increase, the level of protection of human and animal health ensured in the Union.

   In that regard, even though the recitals of the preamble to Regulation No 1923/2006 do not contain any explanation as to the purpose of the proposal concerned, it is clear from those travaux préparatoires that Article 24a of Regulation No 999/2001 was envisaged as a guarantee aimed at preventing measures which lower the level of protection of human and animal health in the European Union from being adopted under the comitology procedure. It does not, however, follow that Article 24a of Regulation No 999/2001 excludes any relaxation of the earlier preventive measures. First of all, Article 24a of Regulation No 999/2001 does not lay down as a yardstick the fact that the comparison must be carried out with respect to the level of protection resulting from the earlier preventive measures adopted in the same field, but refers in general to the level of health assured in the Union. Second, it follows from both Article 7(2) of Regulation No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety and the Court’s case-law that the provisional risk management measures, which are adopted in the context of scientific uncertainty, must be re-examined within a reasonable amount of time in order to ensure that they are proportionate and no more restrictive of trade than is required to achieve the high level of health protection chosen by the Union.

   Therefore, the level of protection of human health is tightly correlated to the level of risk deemed acceptable for society, which depends, in turn, on the scientific knowledge available at a given moment. It cannot be ruled out that, in the light of scientific progress, the same level of protection may be ensured by less restrictive measures.

   (see paras 131-136)

6.  As regards the assessment of the risks to human health, since the determination of the level of risk deemed acceptable falls within the sphere in which the Commission is called on to undertake complex assessments and enjoys broad discretion, judicial review of the exercise of its powers must be limited to examining whether it is vitiated by a manifest error of assessment or whether the legislature has manifestly exceeded the limits of its discretion.

   (see paras 142, 143)

7.  See the text of the decision.

   (see para. 149)