Case T-257/07

French Republic

v

European Commission

(Health policy – Regulation (EC) No 999/2001 – Protection against transmissible spongiform encephalopathies – Sheep and goats – Regulation (EC) No 746/2008 – Adoption of less restrictive eradication measures than those earlier prescribed – Precautionary principle)

Summary of the Judgment

1.      Agriculture – Common agricultural policy – Implementation – Measures for protection of human health – Application of the precautionary principle

(Arts 3(p) EC, 6 EC, 152(1) EC, 153(1) and (2) EC and 174(1) and (2) EC; European Parliament and Council Regulation No 178/2002, Art. 7(1))

2.      Agriculture – Common agricultural policy – Implementation – Scientific evaluation of risks

(Art. 152(1) EC; European Parliament and Council Regulation No 178/2002, Art. 6(2))

3.      Agriculture – Common agricultural policy – Implementation – Evaluation of risks – Determination of level of risk

(Art. 152(1) EC)

4.      Agriculture – Common agricultural policy – Implementation – Taking into account requirements relating to protection of public health, safety and the environment – Application of the precautionary principle

(Art. 152(1) EC; European Parliament and Council Regulation No 178/2002, Art. 7(2))

5.      Agriculture – Common agricultural policy – Discretion of European Union institutions – Scope – Judicial review – Limits

6.      Plea of illegality – Subject-matter – Assessment of lawfulness – Criteria

(Art. 263 TFEU)

7.      Agriculture – Common agricultural policy – Application of the precautionary principle – Scope – Limits – Respect for guarantees conferred by the Community legal order in administrative procedures

(Art. 152(1) EC)

8.      Agriculture – Approximation of laws on animal health – Measures of protection against transmissible spongiform encephalopathies – Identification of animals at risk in an inquiry

(European Parliament and Council Regulation No 999/2001, Arts 13(1)(b) and (c), 23 and 24(2))

1.      The precautionary principle is a general principle of European Union law arising from Article 3(p) EC, Article 6 EC, Article 152(1) EC, Article 153(1) and (2) EC and Article 174(1) and (2) EC, requiring the authorities in question, in the particular context of the exercise of the powers conferred on them by the relevant rules, to take appropriate measures to prevent specific potential risks to public health, safety and the environment, by giving precedence to the requirements related to the protection of those interests over economic interests.

Moreover, as is made clear by Article 7(1) 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, in the context of food law, the precautionary principle allows the adoption of provisional risk management measures necessary to ensure a high level of health protection when, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists.

Thus, where there is scientific uncertainty as to the existence or extent of risks to human health, the precautionary principle allows the institutions to take protective measures without having to wait until the reality and seriousness of those risks become fully apparent or until the adverse health effects materialise.

Within the process leading to the adoption by an institution of appropriate measures to prevent specific potential risks to public health, safety and the environment by reason of the precautionary principle, three successive stages can be identified: firstly, identification of the potentially adverse effects arising from a phenomenon; secondly, assessment of the risks to public health, safety and the environment which are related to that phenomenon; thirdly, when the potential risks identified exceed the threshold of what is acceptable for society, risk management by the adoption of appropriate protective measures.

(see paras 66-69)

2.      Assessment of the risks to public health, safety and the environment consists, for the institution required to cope with potentially adverse effects arising from a phenomenon, in scientifically assessing those risks and in determining whether they exceed the level of risk deemed acceptable for society. Thus, in order for the European Union institutions to be able to carry out a risk assessment, it is important for them, firstly, to have a scientific assessment of the risks and, secondly, to determine what level of risk is deemed unacceptable for society.

In particular, a scientific risk assessment is a scientific process consisting, in so far as possible, in the identification and characterisation of a hazard, the assessment of exposure to that hazard and the characterisation of the risk. As a scientific process, the scientific risk assessment must be entrusted by the institution to scientific experts.

Moreover, in accordance with Article 6(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, the scientific risk assessment is to be based on the available scientific evidence and undertaken in an independent, objective and transparent manner. It is important to point out in that regard that the duty imposed on the institutions to ensure a high level of protection of public health, safety and the environment means that they must ensure that their decisions are taken in the light of the best scientific information available and that they are based on the most recent results of international research.

The scientific risk assessment is not required to provide the institutions with conclusive scientific evidence of the reality of the risk and the seriousness of the potential adverse effects were that risk to become a reality. A situation in which the precautionary principle is applied by definition coincides with a situation in which there is scientific uncertainty. However, a preventive measure cannot properly be based on a purely hypothetical approach to the risk, founded on mere conjecture which has not been scientifically verified.

Furthermore, the adoption of a preventive measure, or, conversely, its withdrawal or relaxation, cannot be made subject to proof of the lack of any risk, in so far as such proof is generally impossible to give in scientific terms since zero risk does not exist in practice. It follows that a preventive measure may be taken only if the risk, although the reality and extent thereof have not been ‘fully’ demonstrated by conclusive scientific evidence, appears nevertheless to be adequately backed up by the scientific data available at the time when the measure was taken. In such a situation, ‘risk’ thus corresponds to the degree of probability that the acceptance of certain measures or practices will adversely affect the interests safeguarded by the legal order.

Finally, it may prove impossible to carry out a full scientific risk assessment because of the inadequate nature of the available scientific data. However, that does not prevent the competent public authority from taking preventive measures in accordance with the precautionary principle. It is important, in such a situation, that scientific experts carry out a scientific risk assessment notwithstanding the existing scientific uncertainty, so that the competent public authority has available to it sufficiently reliable and cogent information to allow it to understand the ramifications of the scientific question raised and decide upon a policy in full knowledge of the facts.

It follows that the necessity or otherwise of certain evaluations made by scientists participating in the scientific assessment of the risks to human health arising from the adoption of provisions relaxing the provisional measures adopted pursuant to the precautionary principle is assessed in the light, inter alia, of the available data.

(see paras 70-71, 73-77, 178-179)

3.      As regards the evaluation of risks, the responsibility for determining the level of risk which is deemed unacceptable for society lies, provided that the applicable rules are observed, with the institutions responsible for the political choice of determining an appropriate level of protection for society. It is for those institutions to determine the critical probability threshold for adverse effects on public health, safety and the environment and for the seriousness of those possible effects which, in their judgement, is no longer acceptable for society and above which it is necessary, in the interests of protecting public health, safety and the environment, to take preventive measures in spite of any existing scientific uncertainty.

In determining the level of risk deemed unacceptable for society, the institutions are bound by their obligation to ensure a high level of protection of public health, safety and the environment. That high level of protection does not necessarily, in order to be compatible with that provision, have to be the highest that is technically possible. Moreover, those institutions may not take a purely hypothetical approach to risk and may not base their decisions on a ‘zero risk’.

The level of risk deemed unacceptable for society will depend on the assessment made by the competent public authority of the particular circumstances of each individual case. In that regard, the authority may take account, inter alia, of the severity of the impact on public health, safety and the environment were the risk to occur, including the extent of possible adverse effects, the persistency or reversibility of those effects and the possibility of delayed effects as well as of the more or less concrete perception of the risk based on available scientific knowledge.

(see paras 78-80)

4.      In the application of the precautionary principle, risk management corresponds to the body of actions taken by an institution faced with a risk in order to reduce it to a level deemed acceptable for society having regard to its obligation to ensure a high level of protection of public health, safety and the environment. Where that risk exceeds the level of risk deemed acceptable for society, the institution is bound, by reason of the precautionary principle, to adopt provisional risk management measures necessary to ensure a high level of protection.

In accordance with 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, the provisional measures in question must be proportionate, non-discriminatory, transparent, and consistent with similar measures already taken.

Finally, it is for the competent authority to review the provisional measures in question within a reasonable period. When new elements change the perception of a risk or show that that risk can be contained by measures less restrictive than the existing measures, it is for the institutions, and in particular the Commission, which has the power of initiative, to bring about an amendment to the rules in the light of the new information. In any event, the relaxation of preventive measures adopted previously must be justified by new elements changing the assessment of the risk in question.

When those new elements, such as new knowledge or new scientific discoveries, justify a relaxation of a preventive measure, they change the specific content of the obligation for the public authorities to maintain consistently a high level of protection of human health. Indeed, those new elements may change the perception of the risk and the level of risk which are deemed acceptable by society. The legality of the adoption of a less restrictive preventive measure is not assessed on the basis of the level of risk deemed acceptable which was taken into account for the adoption of the initial preventive measures. Indeed, the adoption of initial preventive measures in order to reduce the risk to a level deemed acceptable takes place on the basis of a risk assessment and, in particular, of the determination of the level of risk deemed acceptable for society. If new elements change that risk assessment, the legality of the adoption of less restrictive preventive measures must be assessed in the light of those new elements and not in the light of the elements which determined the risk assessment in the context of the adoption of the initial preventive measures. It is only when that new level of risk exceeds the level of risk deemed acceptable for society that a breach of the precautionary principle must be found by the Court.

(see paras 81-83, 212-213)

5.      In matters concerning the common agricultural policy, the European Union institutions enjoy a broad discretion regarding definition of the objectives to be pursued and choice of the appropriate means of action. In addition, in the context of their risk assessment, they must carry out complex assessments in order to determine, in the light of the technical and scientific information which is provided to them by experts in the context of the scientific risk assessment, whether the risks to public health, safety and the environment exceed the level of risk deemed acceptable for society.

That broad discretion and those complex assessments imply a limited power of review on the part of the Courts of the European Union. That discretion and those assessments have 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.

As regards the assessment by the Courts of the European Union as to whether an act of an institution is vitiated by a manifest error of assessment, it must be stated that, in order to establish that that institution committed a manifest error in assessing complex facts such 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.

The limits to the review by the Courts of the European Union do not, however, 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.

Moreover, where an institution has a wide discretion, the review of observance of guarantees conferred by the European Union legal order in administrative procedures is of fundamental importance. Those guarantees include, in particular for the competent institution, the obligations to examine carefully and impartially all the relevant elements of the individual case and to give an adequate statement of the reasons for its decision.

Thus, a scientific risk assessment carried out as thoroughly as possible on the basis of scientific advice founded on the principles of excellence, transparency and independence is an important procedural guarantee whose purpose is to ensure the scientific objectivity of the measures adopted and preclude any arbitrary measures.

(see paras 84-89, 214)

6.      The legality of a European Union measure is assessed on the basis of the elements of fact and of law existing at the time when the measure was adopted. It follows that elements post-dating the adoption of the European Union measure cannot be taken into account in assessing the legality of that measure.

(see para. 172)

7.      The European Union institutions enjoy a wide discretion as to the choice of the appropriate means of action in matters concerning the common agricultural policy. Moreover, although those institutions are obliged to ensure a high level of protection of human health, they also enjoy a wide discretion as to the choice of appropriate means of action in order to comply with that obligation. That wide discretion enjoyed by the institutions means that the review of observance of guarantees conferred by the European Union legal order in administrative procedures is of fundamental importance.

One of those guarantees consists in requiring the authorities to have available to them all the relevant information for that purpose when they adopt provisional measures pursuant to the precautionary principle in order to ensure a high level of protection of human health. It is therefore important for them to have available to them a scientific risk assessment founded on the principles of excellence, transparency and independence. That requirement constitutes an important guarantee designed to ensure the scientific objectivity of the measures adopted and preclude any arbitrary measures.

Another of those guarantees consists in requiring the authorities to have available to them a scientific assessment of the risks to human health to which the adoption of such provisions gives rise when they adopt provisions relaxing provisional measures adopted pursuant to the precautionary principle in order to ensure a high level of protection of human health. Such a scientific assessment of the risks to human health includes, in principle, a comprehensive evaluation, by scientific experts, of the probability of exposure of humans to harmful effects of the measures for their health. Consequently, it includes, in principle, a quantitative evaluation of the risks in question.

(see paras 174-177)

8.      Under Article 13(1)(b) of Regulation No 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies, an inquiry is to be carried out to identify all animals at risk in accordance with Annex VII, point 1. In addition, under Article 13(1)(c) of that regulation, all animals and products thereof at risk, as listed in Annex VII, point 2, to that regulation, identified by the inquiry referred to in point (b) of paragraph 1 of Article 13 are to be killed and disposed of in accordance with Regulation (EC) No 1774/2002. Thus, according to that provision, the animals which must be killed and disposed of are those which are identified by the inquiry to be carried out in accordance with point 1 of Annex VII to Regulation No 999/2001 and which, in addition, fulfil the criteria in point 2 of that annex.

According to Article 23 of Regulation No 999/2001, the Commission may amend the annexes to that regulation, in accordance with the comitology procedure referred to in Article 24(2) thereof, after consultation of the appropriate scientific committee on any question which could have an impact on public health. Thus, the legislature has delegated to the Commission the power to amend the annexes to Regulation No 999/2001.

In the light of the scope of Article 13(1)(c) and Article 23 of Regulation No 999/2001, the Commission has the power to limit, by regulation adopted in accordance with the comitology procedure referred to in Article 24(2) of Regulation No 999/2001, the animals identified by the inquiry which must be killed and disposed of. Indeed, since Article 13(1)(c) of Regulation No 999/2001 defines the animals to be killed and disposed of by referring to the criteria in point 2 of Annex VII, the Commission has the power, under Article 23 of Regulation No 999/2001, to adopt provisions limiting the animals to be killed and disposed of which have been identified by the abovementioned inquiry.

(see paras 206-208)