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)

JUDGMENT OF THE GENERAL COURT (Third Chamber, Extended Composition)

9 September 2011 ( )

(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)

In Case T‑257/07,

French Republic, represented initially by E. Belliard, G. de Bergues, R. Loosli-Surrans and A.-L. During, and subsequently by E. Belliard, G. de Bergues, R. Loosli-Surrans and B. Cabouat, acting as Agents,

applicant,

v

European Commission, represented by M. Nolin, acting as Agent,

defendant,

supported by

United Kingdom of Great Britain and Northern Ireland, represented initially by I. Rao and C. Gibbs, subsequently by I. Rao and L. Seeboruth, and finally by L. Seeboruth and F. Penlington, acting as Agents, and by T. Ward, Barrister,

intervener,

APPLICATION for annulment of Commission Regulation (EC) No 746/2008 of 17 June 2008 amending Annex VII to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ 2008 L 202, p. 11), in that it authorises less restrictive measures of surveillance and eradication than those earlier prescribed for ovine and caprine flocks,

THE GENERAL COURT (Third Chamber, Extended Composition),

composed of J. Azizi (Rapporteur), President, E. Cremona, I. Labucka, S. Frimodt Nielsen and K. O’Higgins, Judges,

Registrar: C. Kristensen, Administrator,

having regard to the written procedure and further to the hearing on 6 July 2010,

gives the following

Judgment

Legal context

1. Regulation (EC) No 178/2002

1 Article 7 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 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 (OJ 2002 L 31, p. 1) provides:

‘1. In specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the Community may be adopted, pending further scientific information for a more comprehensive risk assessment.

2. Measures adopted on the basis of paragraph 1 shall be proportionate and no more restrictive of trade than is required to achieve the high level of health protection chosen in the Community, regard being had to technical and economic feasibility and other factors regarded as legitimate in the matter under consideration. The measures shall be reviewed within a reasonable period of time, depending on the nature of the risk to life or health identified and the type of scientific information needed to clarify the scientific uncertainty and to conduct a more comprehensive risk assessment.’

2. Regulation (EC) No 999/2001

2 Article 13(1) of Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ 2001 L 147, p. 1) provides:

‘When the presence of a TSE has been officially confirmed, the following measures shall be applied as soon as possible:

(a) all parts of the body of the animal shall be disposed of …;

(b) an inquiry shall be carried out to identify all animals at risk in accordance with Annex VII, point 1;

(c) all animals and products thereof at risk, as listed in Annex VII, point 2, [to] this Regulation, identified by the inquiry referred to in point (b) of this paragraph shall be killed and disposed of in accordance with Regulation (EC) No 1774/2002.’

3 Before the entry into force of Commission Regulation (EC) No 727/2007 of 26 June 2007 amending Annexes I, III, VII and X to Regulation (EC) No 999/2001 (OJ 2007 L 165, p. 8), Annex VII to Regulation No 999/2001, headed ‘Eradication of transmissible spongiform encephalopathy’, provided:

‘1. The inquiry referred to in Article 13(1)(b) must identify:

…

(b) in the case of ovine and caprine animals:

– all ruminants other than ovine and caprine animals on the holding of the animal in which the disease was confirmed,

– in so far as they are identifiable, the parents, and in the case of females all embryos, ova and the last progeny of the female animal in which the disease was confirmed,

– all other ovine and caprine animals on the holding of the animal in which the disease was confirmed in addition to those referred to in the second indent,

– the possible origin of the disease and the identification of other holdings on which there are animals, embryos or ova which may have become infected by the TSE agent or been exposed to the same feed or contamination source,

– the movement of potentially contaminated feedingstuffs, other material or any other means of transmission, which may have transmitted the TSE agent to or from the holding in question.

2. The measures laid down in Article 13(1)(c) shall comprise at least:

…

(b) in the case of confirmation of TSE in an ovine or caprine animal, from 1 October 2003, according to the decision of the competent authority:

(i) the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b) or

(ii) the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b), with the exception of:

– breeding rams of the ARR/ARR genotype,

– breeding ewes carrying at least one ARR allele and no VRQ allele and, where such breeding ewes are pregnant at the time of the inquiry, the lambs subsequently born, if their genotype meets the requirements of this subparagraph,

– sheep carrying at least one ARR allele which are intended solely for slaughter,

– if the competent authority so decides, sheep and goats less than two months old which are intended solely for slaughter;

(iii) if the infected animal has been introduced from another holding, a Member State may decide, based on the history of the case, to apply eradication measures in the holding of origin in addition to, or instead of, the holding in which the infection was confirmed; in the case of land used for common grazing by more than one flock, Member States may decide to limit the application of those measures to a single flock, based on a reasoned consideration of all the epidemiological factors; where more than one flock is kept on a single holding, Member States may decide to limit the application of the measures to the flock in which scrapie has been confirmed, provided it has been verified that the flocks have been kept isolated from each other and that the spread of infection between the flocks through either direct or indirect contact is unlikely.

(c) in the case of confirmation of BSE in an ovine or caprine animal, killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second to fifth indents of point 1(b).’

4 Article 23 of Regulation No 999/2001 provides:

‘After consultation of the appropriate scientific committee on any question which could have an impact on public health, the annexes shall be amended or supplemented and any appropriate transitional measures shall be adopted in accordance with the procedure referred to in Article 24(2) …’

5 Article 24a of Regulation No 999/2001 provides:

‘Decisions to be adopted in accordance with one of the procedures referred to in Article 24 shall 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 Community.’

Contested measures

6 In order to take account of the most recent scientific data, Annexes I, III, VII and X to Regulation No 999/2001 governing certain measures to control transmissible spongiform encephalopathies (TSEs) in ovine and caprine animals were amended by Regulation No 727/2007.

7 Annex VII to Regulation No 999/2001, which lays down inter alia eradication measures to be applied following confirmation of the existence of a case of TSE within a flock of ovine or caprine animals, was then the subject of a further amendment by Commission Regulation (EC) No 746/2008 of 17 June 2008 amending Annex VII to Regulation (EC) No 999/2001 (OJ 2008 L 202, p. 11; ‘the contested regulation’).

8 The contested regulation amended Annex VII to Regulation No 999/2001 by inserting a Chapter A, headed ‘Measures following confirmation of the presence of a TSE’, and replacing point 2(b) of Annex VII to Regulation No 999/2001 with the following:

‘2. The measures laid down in Article 13(1)(c) shall comprise at least:

…

2.3. In the case of confirmation of TSE in an ovine or caprine animal:

(a) if BSE cannot be excluded after the results of a ring trial carried out in accordance with the procedure set out in Annex X, Chapter C, point 3.2(c), the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second to fifth indents of point 1(b);

(b) if BSE is excluded in accordance with the procedure set out in Annex X, Chapter C, point 3.2(c), pursuant to the decision of the competent authority:

either

(i) the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b). The conditions set out in point 3 shall apply to the holding;

or

(ii) the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b), with the exception of:

– breeding rams of the ARR/ARR genotype,

– breeding ewes carrying at least one ARR allele and no VRQ allele and, where such breeding ewes are pregnant at the time of the inquiry, the lambs subsequently born, if their genotype meets the requirements of this subparagraph,

– sheep carrying at least one ARR allele which are intended solely for slaughter,

– if the competent authority so decides, sheep and goats less than three months old which are intended solely for slaughter.

The conditions set out in point 3 shall apply to the holding;

or

(iii) a Member State may decide not to kill and destroy the animals identified by the inquiry referred to in the second and third indents of point 1(b) where it is difficult to obtain replacement ovine animals of a known genotype or where the frequency of the ARR allele within the breed or holding is low, or where it is deemed necessary in order to avoid inbreeding, or based on a reasoned consideration of all the epidemiological factors. The conditions set out in point 4 shall apply to the holding.

…’

9 Point 4 of Chapter A of Annex VII to Regulation No 999/2001, inserted by the contested regulation, states:

‘Following the application on a holding of the measures set out in point 2.3(b)(iii) and for a period of two breeding years following the detection of the last TSE case:

(a) all ovine and caprine animals on the holding shall be identified;

(b) all ovine and caprine animals on the holding may be moved only within the territory of the concerned Member State for slaughter for human consumption or for the purposes of destruction; all animals over the age of 18 months slaughtered for human consumption shall be tested for the presence of TSE in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3.2(b);

…

(e) all ovine and caprine animals which are over the age of 18 months which have died or been killed on the holding shall be subject to TSE testing;

(f) only male sheep of the ARR/ARR genotype and female ovine animals from holdings where no TSE cases have been detected or from flocks fulfilling the conditions set out in point 3.4 may be introduced in the holding;

(g) only caprine animals from holdings where no TSE cases have been detected or from flocks fulfilling the conditions of point 3.4 may be introduced in the holding;

…’

10 In addition, point 2.3(d) of Chapter A of Annex VII to Regulation No 999/2001, as amended by the contested regulation, provides:

‘(d) Member States may decide:

(i) to replace the killing and complete destruction of all animals referred to in b(i) by slaughtering for human consumption;

(ii) to replace the killing and complete destruction of animals referred to in b(ii) by slaughtering for human consumption provided that:

– the animals are slaughtered within the territory of the concerned Member State;

– all animals which are over 18 months of age or have more than two permanent incisors erupted through the gum and are slaughtered for human consumption shall be tested for the presence of TSE in accordance with the laboratory methods set out in Annex X, Chapter C, point 3.2(b)’.

11 Finally, point 3.1 of Chapter A of Annex VII to Regulation No 999/2001, amended by the contested regulation, is identical to point 4 of the previous version of Annex VII to Regulation No 999/2001 and provides:

‘Only the following animals may be introduced to the holding(s):

(a) male sheep of the ARR/ARR genotype;

(b) female sheep carrying at least one ARR allele and no VRQ allele;

(c) caprine animals, provided that:

(i) no ovine animals for breeding other than those of the genotypes referred to in points (a) and (b) are present on the holding;

(ii) thorough cleaning and disinfection of all animal housing on the premises has been carried out following destocking.’

Facts

1. Transmissible spongiform encephalopathies

12 TSEs are neurodegenerative diseases with a slow rate of development and fatal outcome. They are characterised by particular lesions of the central nervous system (the brain and spinal cord) and affect both animals and humans.

13 TSEs are all caused by a non-conventional transmissible agent called a ‘prion’. This term refers to an infectious proteinaceous infectious particle, namely an abnormal form of the prion protein (PrP), which is a normal protein of the host.

14 Among the TSEs which can affect ovine, caprine or bovine animals, it is possible to distinguish the following pathologies: bovine spongiform encephalopathy (BSE), classical scrapie and atypical scrapie.

2. Bovine spongiform encephalopathy

15 BSE is a TSE which was identified for the first time in November 1986 in the United Kingdom. It affects bovine animals and is transmissible to humans, in whom it causes a new variant of Creutzfeldt-Jakob disease. It is also considered to be a disease capable of affecting ovine and caprine animals. On the basis of molecular and histopathological criteria, it is possible to distinguish classical BSE, L-type BSE and H-type BSE.

3. Scrapie

16 Scrapie is a TSE which affects ovine and caprine animals. It has been known in Europe since the early 18th century. It is transmitted mainly from the mother to her progeny immediately after birth or from the mother to other receptive newborns which are exposed to the foetal waters or to tissues from an infected animal. The frequency of transmission of scrapie to adult animals is much lower.

17 The term ‘classical scrapie’ refers to a group of varieties (strains) of TSE not classified to date but which have a number of characteristics considered representative. Those pathologies manifest themselves, from a molecular point of view, in wide dissemination of the prion within the organism, in contagion within flocks and between flocks and in genetic susceptibility or genetic resistance which varies according to the animal.

18 Sheep develop scrapie differently depending on the structure of the gene coding for PrP (‘the PrP gene’) and, more specifically, on the nature of the three amino-acids at positions 136, 145 and 171 in the PrP amino-acid sequence and which are designated by the upper-case letters ‘A’ for alanine, ‘R’ for arginine, ‘Q’ for glutamine and ‘V’ for valine, which serve to distinguish between the various forms of PrP. Four alleles of the PrP gene are known, namely the VRQ, ARQ, AHQ and ARR alleles. Sheep carrying the VRQ allele are hyper-susceptible to scrapie. They develop that disease rapidly and detectable traces of prion are found in many of the animal’s organs throughout the disease incubation period. Sheep carrying ARQ or AHQ alleles are relatively susceptible to scrapie. Finally, sheep carrying the ARR allele have a virtually absolute resistance to scrapie. Animals carrying at least one ARR allele are semi-resistant to scrapie. In those animals, multiplication of the prion is very slow. It is confined to the nervous system and the prion is not detectable before the appearance of the clinical signs of the disease.

19 The term ‘atypical scrapie’ seems to correspond to a single variety of TSE. That pathology has characteristics considered atypical in small ruminants, such as a concentration of the prion in the central nervous system, limited or non-existent contagion and the absence of confirmed genetic resistance. Animals of the ARR/ARR genotype are therefore susceptible to infection with that pathology. However, the concentration of the prion in the central nervous system renders the screening measures and the removal of risk materials at the slaughterhouse very effective.

4. Developments in Community policy for controlling TSEs in ovine and caprine animals

20 Given that there was a theoretical possibility that BSE could also infect ovine and caprine animals under natural conditions, measures for the prevention and eradication of TSEs in the ovine and caprine population were introduced into Community legislation (see, inter alia, recital 3 in the preamble to Commission Regulation (EC) No 1139/2003 of 27 June 2003 amending Regulation (EC) No 999/2001 as regards monitoring programmes and specified risk material (OJ 2003 L 160, p. 22)).

21 On 22 May 2001, the Parliament and the Council adopted Regulation No 999/2001 which brings together within a single text all the provisions concerning control of TSEs which existed on that date. That regulation prohibits the feeding to ruminants of meal derived from animal protein, also known as meat and bone meal or ‘MBM’ (see Article 7(1) and Annex IV). It requires the disposal of the ‘specified risk material’, also known as ‘SRM’, that is to say, the tissues which are most susceptible to infection by a TSE (see Article 8 and Annex V). It lays down measures concerning animals suspected of having been infected with a TSE and measures to be followed in the case of confirmation of the presence of a TSE in animals. Those measures include the destruction of animals at risk as defined in Annex VII to Regulation No 999/2001 in its original version (see Articles 12 and 13 and Annex VII). Moreover, it requires each Member State to introduce an annual programme for monitoring TSEs. For ovine and caprine animals, that monitoring is to be carried out inter alia on the basis of screening using ‘rapid tests’ on samples of the ovine and caprine population (see Article 6 and Annex III). Finally, in order to take account of developments in scientific knowledge, Article 23 of that regulation provides that its annexes may be amended and supplemented subject to compliance with a comitology procedure including consultation of the Scientific Steering Committee.

22 In accordance with the latter provision, Regulation No 99/2001 was amended on several occasions between 2001 and 2007. Those amendments related inter alia to measures to control TSEs in ovine and caprine animals in the light of developments in scientific knowledge concerning TSEs.

23 Thus, on 14 February 2002, the Commission adopted Regulation (EC) No 270/2002 amending Regulation (EC) No 999/2001 as regards specified risk material and epidemio-surveillance for TSEs and amending Regulation (EC) No 1326/2001 as regards animal feeding and the placing on the market of ovine and caprine animals and products thereof (OJ 2002 L 45, p. 4). The purpose of that regulation is, inter alia, to revise the rules for the monitoring of TSEs in ovine and caprine animals to take account of the opinion of 18 and 19 October 2001 of the Scientific Steering Committee, which recommended that a survey of the incidence of TSEs should urgently be carried out with the available ‘rapid tests’ using a statistically sound sample design and size (see recital 2 in the preamble to Regulation No 270/2002). That regulation thus provides for the monitoring of ovine and caprine animals on the basis of ‘rapid tests’ carried out by the Member State on a sample of a minimum size significantly larger than that laid down in the previous version of Regulation No 999/2001. In addition, it provides that the prion genotype is to be determined for each positive TSE case in sheep (see Annex I to Regulation No 270/2002).

24 The ‘rapid tests’ referred to in Regulation No 999/2001 and its amended versions are tests which make it possible to detect TSEs in a short period of time on the basis of samples taken from the bodies of animals or from the carcasses of animals taken to slaughter. That screening by means of ‘rapid tests’ enables only the existence of a TSE to be identified, but not its type, that is BSE, classical scrapie or atypical scrapie. Where the results of those ‘rapid tests’ are positive, the brainstem is sent to a reference laboratory specified in Annex X to Regulation No 999/2001 (‘the reference laboratory’) to undergo confirmatory examinations. The confirmatory examinations consist of examinations by immunocytochemistry, examinations by immunoblotting, histopathological examinations of the cerebral tissues and/or the demonstration of characteristic fibrils by electron microscopy (taken together, ‘the confirmatory examinations’) (see Commission Regulation (EC) No 1248/2001 of 22 June 2001 amending Annexes III, X and XI to Regulation (EC) No 999/2001 (OJ 2001 L 173, p. 12)). Where, following those tests, BSE cannot be excluded, those tests are to be supplemented by biological tests, also known as ‘bioassays’ or ‘strain typing’. Those tests consist in inoculating tissues contaminated with TSE into the brain of a live mouse in order to determine the nature of the TSE in question, namely BSE or scrapie. When the mouse dies, a microscopic examination of its brain is carried out and the results of that examination make it possible to determine the exact nature of the TSE. Those biological tests make it possible to determine with accuracy whether or not the TSE is BSE only after several years. Tests to distinguish BSE from other TSEs are commonly referred to as ‘discriminatory tests’.

25 At the time of the adoption of Regulation No 270/2002, the only reliable discriminatory tests were biological tests. There were no reliable molecular discriminatory tests making it possible to distinguish between BSE and scrapie infection in ovine and caprine animals (see recital 3 in the preamble to Regulation No 1139/2003).

26 In June 2003, the Commission commissioned the reference laboratory to bring together a group of experts on strain typing of TSEs (‘STEG’) whose task was to develop and validate the use of tests to replace biological discriminatory tests for TSEs. STEG’s work led to the validation of ‘biochemical’ or ‘molecular’ tests capable of differentiating BSE from scrapie. Those molecular discriminatory tests make it possible to exclude the presence of BSE in tissues in the space of a few days or even a few weeks.

27 On 12 January 2005, following the development of the molecular discriminatory tests, the Commission adopted Regulation (EC) No 36/2005 amending Annexes III and X to Regulation (EC) No 999/2001 as regards epidemio-surveillance for TSEs in bovine, ovine and caprine animals (OJ 2005 L 10, p. 9), in order, inter alia, to permit the use of those molecular discriminatory tests in the monitoring system introduced by Regulation No 999/2001.

28 Thus, Regulation No 36/2005 provides that, if, in the context of monitoring flocks of caprine and ovine animals, the result of ‘rapid tests’ on a sample taken proves inconclusive or positive and if that result is confirmed during the confirmatory examinations, the animal is to be regarded as a ‘positive scrapie case’, also known as an ‘index case’. That case is to be subjected to primary molecular testing with discriminatory immunoblotting. Where the primary testing does not make it possible to exclude the presence of BSE, that case is then to be subjected to three further discriminatory molecular tests: a second test with immunoblotting, a test with immunocytochemistry and an enzyme-linked immunosorbent assay, also known as an ELISA. Only samples indicative for BSE and those inconclusive following those discriminatory molecular tests are to undergo mouse bioassays for final confirmation (see point 3.2 of Chapter C of Annex X to Regulation No 999/2001, as amended by Regulation No 36/2005). That regulation also requires TSE typing with discriminatory tests for all prion strains detected in small ruminants following a rapid test. Finally, the regulation requires testing of a large sample of all flocks containing an infected animal.

29 Under the regulations cited above, Member States had only the choice, when an animal was infected with a TSE, which was not BSE, in a flock of ovine or caprine animals, either to destroy all the animals in the flock to which the infected animal belonged or, where the infected animal was an ovine animal, only to destroy the genetically susceptible animals in the flock after the genotype of all the animals in the flock had been determined in order to distinguish susceptible animals from resistant animals. In addition, the Member State was free not to kill sheep and goats less than two months old which were intended solely for slaughter (see paragraph 3 above). By contrast, where an animal was infected with BSE, Member States were required to ensure that all sheep and goats, embryos, ova and all animals were killed and completely destroyed, and that the material and other means of transmission were disposed of.

30 Following the confirmation, on 28 January 2005, of the presence of BSE in a goat born in 2000 and slaughtered in France in 2002, a programme of increased monitoring of caprine animals was introduced. It was the first case of BSE in a small ruminant under natural conditions (see recitals 2 to 4 in the preamble and annex to Commission Regulation (EC) No 214/2005 of 9 February 2005 amending Annex III to Regulation (EC) No 999/2001 as regards monitoring of TSEs in caprine animals (OJ 2005 L 37, p. 9)).

31 On 15 July 2005, the Commission adopted a communication entitled ‘TSE Road Map’ (COM(2005) 322 final; ‘the TSE Road Map’), in which it announced its intention to propose measures designed to relax the eradication measures in force for small ruminants taking into account the new diagnostic tools available while ensuring the current level of consumer protection. In particular, it stated that the molecular discriminatory testing in force since January 2005 made it possible to exclude the presence of BSE within a few weeks in most TSE cases. Furthermore, it took the view that, when BSE was excluded, a public health risk was no longer present and total herd culling might be considered disproportionate on public health grounds. It then presented a table showing, in percentages ranging from 0.3 to 3.5, the number of sheep and goats declared ‘positive’ within infected herds for the period from 2002 to 2004. It also stated that it wished to propose a relaxation of the policy of culling sheep and goats for all cases where BSE was excluded, with an increased testing regime within the infected herds and the slaughter for human consumption of all animals of all ages in infected herds if the results of ‘rapid testing’ were negative. Finally, it stated that conditions for herd certification should also be considered as an additional way of eradicating TSEs (see points 2.5.1 and 2.5.2 of the TSE Road Map).

32 On 21 September 2005, the French authorities referred the matter to the Agence française de sécurité sanitaire des aliments (French Food Safety Authority; ‘AFSSA’) so that it could examine, firstly, the health risks entailed by the measures proposed by the Commission in the TSE Road Map with regard to ovine and caprine animals and, secondly, the reliability of discriminatory tests.

33 On 26 October 2005, the European Food Safety Authority (EFSA) adopted an opinion on classification of atypical TSE cases in small ruminants. In that opinion, it concluded that an operational definition of atypical scrapie was possible. In addition, it recommended that monitoring programmes use appropriate combinations of tests and sampling to ensure that atypical scrapie cases continue to be identified.

34 Between December 2005 and February 2006, the monitoring programmes for TSEs implemented in the European Community made it possible to detect two sheep from France and one sheep from Cyprus suspected of being infected with BSE. In an opinion of 8 March 2006, a panel of experts on TSEs chaired by the reference laboratory considered that, even though the samples from those three sheep were not consistent with the data contained in the database for ‘experimental ovine BSE’, there was not sufficient evidence to eliminate the presence of BSE categorically. Consequently, some biological tests were undertaken by inoculating mice with the three suspect samples. Following the detection of those three suspect cases, the Commission introduced increased monitoring of TSEs in ovine animals in all the Member States (see, inter alia, recitals 2 and 5 in the preamble and annex to Commission Regulation (EC) No 1041/2006 of 7 July 2006 amending Annex III to Regulation (EC) No 999/2001 as regards monitoring of TSEs in ovine animals (OJ 2006 L 187, p. 10)).

35 On 15 May 2006, AFSSA delivered an opinion on the developments in Community legislation proposed by the TSE Road Map. In that opinion, it opposed the Commission’s proposal to relax the culling policy in order to allow the release for human consumption of meat from animals from herds of small ruminants infected with scrapie. It expressed the view that ‘rapid tests’ for prion strain typing, namely molecular discriminatory tests, did not make it possible to exclude the presence of BSE in a flock and that it was not possible to conclude that, with the exception of BSE, all TSE strains potentially present in small ruminants, including atypical forms, did not pose any health risk for humans.

36 The proposals contained in the TSE Road Map were submitted to the Standing Committee on the Food Chain and Animal Health, which is the competent committee referred to in Article 23 of Regulation No 999/2001.

37 On 22 June and 6 December 2006, the French authorities again referred the matter to AFSSA so that it could assess in detail the measures proposed by the Commission concerning classical scrapie and atypical scrapie.

38 On 15 January 2007, AFSSA gave an opinion relating to the developments in health measures in herds of ovine and caprine animals where a classical or atypical scrapie case was detected after the referrals by the French authorities on 22 June and 6 December 2006. In that opinion, it considered that discriminatory tests did not make it possible to exclude the presence of BSE either in the animal tested or, a fortiori, in the flock to which that animal belonged and that the transmission to humans of TSEs other than BSE could not be excluded. Moreover, it stated that products obtained from ovine and caprine animals from herds infected with classical scrapie, which had been slaughtered under the conditions described in the TSE Road Map, represented an additional risk to public health as compared with products from only genetically resistant ovine animals. Finally, according to AFSSA, a quantitative evaluation of those risks was impossible due to the inadequacy of the data concerning the real prevalence of scrapie in all affected flocks and due to the inadequacy of the data concerning the real genetic structure of the ovine population in general. However, it considered, on the basis of a rough estimate, that the relative risk represented by an animal from an affected flock as compared with an animal from the general population was 20 to 600 times greater. That additional risk would be still further increased if only animals of susceptible genotype from affected flocks were taken into account. Consequently, it recommended retention of the legislation in force concerning classical scrapie.

39 Following the AFSSA opinion of 15 January 2007, the Commission referred the matter to EFSA so that the latter could give an opinion on the two scientific assumptions on which its proposals were based, namely the reliability of discriminatory tests and the non-transmissibility to humans of TSE agents other than BSE.

40 On 25 January 2007, EFSA gave an opinion on the ‘quantitative risk assessment on the residual BSE risk in sheep meat and meat products’. In that opinion, it estimated that, on the basis of the results of the increased monitoring of TSEs, that BSE in sheep concerned, at the most, a few cases, or even a few hundred cases, per million sheep taken to slaughter. It also considered that the most likely prevalence of BSE in sheep is zero. The position statement of 21 December 2006 by the Spongiform Encephalopathy Advisory Committee (SEAC), which provides the Government of the United Kingdom of Great Britain and Northern Ireland with independent scientific advice on TSEs, had already indicated that the most likely scenario was that there was no sheep meat infected with BSE agents in the food chain in the United Kingdom.

41 On 8 March 2007, EFSA gave an opinion on certain aspects related to the risk of TSEs in ovine and caprine animals. In that opinion, it considered that there was no evidence for an epidemiological or molecular link between classical or atypical scrapie and TSEs in humans. It stated that the BSE agent was the only TSE agent which had been identified as zoonotic. However, in view of their diversity, it is not possible to exclude transmissibility to humans of animal TSE agents other than BSE. In addition, it considered that the discriminatory tests as described in the Community legislation appeared, up to then, to be reliable for the differentiation of BSE from classical and atypical scrapie, even though neither their diagnostic sensitivity nor their specificity could be considered to be perfect.

42 On 24 April 2007, following EFSA’s opinion of 8 March 2007, the Commission submitted to the Standing Committee on the Food Chain and Animal Health for a vote a draft regulation amending Annexes I, III, VII and X to Regulation No 999/2001. The draft was adopted by a qualified majority. The Kingdom of Spain, the French Republic and the Italian Republic opposed it. The Republic of Slovenia abstained. The French Republic gave as the reason for its opposition its view that the regulation in question contravened the precautionary principle.

43 On 26 June 2007, the Commission adopted Regulation No 727/2007 against which the French Republic brought an action before the General Court as well as an application for interim measures.

44 On 24 January 2008, at the Commission’s request, EFSA gave an opinion entitled ‘Scientific and technical clarification in the interpretation and consideration of some facets of the conclusions of its Opinion of 8 March 2007 on certain aspects related to the risk of TSEs in ovine and caprine animals’. In that opinion, it clarified its position regarding questions of the transmission to humans of animal TSEs other than BSE and of the reliability of discriminatory tests.

45 On 30 April 2008, the reference laboratory published an updated opinion concerning the cases of TSE in small ruminants under examination. In that opinion, it stated that the two sheep from France and the one sheep from Cyprus (see paragraph 34 above) could not be classed as cases of BSE.

46 On 17 June 2008, the Commission adopted the contested regulation which amends Annex VII to Regulation No 999/2001 by conferring on the Member States a greater choice of measures to adopt when a flock of ovine or caprine animals is affected by a TSE where it has been possible to determine, following a discriminatory test, that it is not BSE. Where, within a herd of small ruminants, an animal is infected with scrapie, Member States may, in essence:

– destroy all the animals in the flock (point 2.3(b)(i) of Chapter A of Annex VII to the contested regulation), or

– in respect of ovine animals, determine the genotype of all the animals in the flock and destroy all genetically susceptible animals (point 2.3(b)(ii) of Chapter A of Annex VII to the contested regulation), or

– slaughter immediately for human consumption all the animals in the flock, although carcasses from animals over 18 months of age may be supplied for consumption only if they have previously been subjected to a rapid test to screen for TSEs which has given a negative result (point 2.3(d)(i) of Chapter A of Annex VII to the contested regulation and point 7.1 of Annex III to Regulation No 999/2001), or

– in respect of ovine animals, determine the genotype of all the animals in the flock, followed by immediate slaughter for human consumption of all susceptible animals, although carcasses from susceptible animals over 18 months of age may be supplied for human consumption only if they have previously been subjected to a rapid test to screen for TSEs which has given a negative result (point 2.3(d)(ii) of Chapter A of Annex VII to the contested regulation), or

– in the case of classical scrapie, keep the animals as they are on the holding with a prohibition on movements of animals to another holding for a period of two years following confirmation of the last case of TSE in the flock, on the understanding that, during that period, the animals may nevertheless be sent for slaughter and their carcasses may be supplied for human consumption if they have previously been subjected to a rapid test to screen for TSEs which has given a negative result (point 2.3(b)(iii) and point 4 of Chapter A of Annex VII to the contested regulation), or

– in the case of atypical scrapie, keep the animals as they are on the holding with a prohibition on exports to other Member States or third countries for a period of two years following confirmation of the last case of TSE in the flock, on the understanding that, during that period, the animals may nevertheless be sent for slaughter and their carcasses may be supplied for human consumption if they have previously been subjected to a rapid test to screen for TSEs which has given a negative result (point 2.3(c) and point 5 of Chapter A of Annex VII to the contested regulation).

Procedure

47 By application lodged at the Registry of the Court on 17 July 2007, the French Republic brought an action for the annulment of point 3 of the annex to Regulation No 727/2007 for breach of the precautionary principle, in so far as it inserts, in Annex VII to Regulation No 999/2001, points 2.3(b)(iii), 2.3(d) and 4 which relax the TSE eradication regime. In addition, it made an application for interim measures, seeking suspension of the operation of that regime.

48 By order of 28 September 2007 in Case T‑257/07 R France v Commission [2007] ECR II‑4153 (the first order in France v Commission), the judge of the General Court hearing applications for interim measures granted that application and suspended the application of those provisions until judgment has been given in the main action.

49 By separate document lodged at the Registry of the Court on 15 October 2007, the United Kingdom of Great Britain and Northern Ireland sought leave to intervene in support of the form of order sought by the Commission. By order of 30 November 2007, the President of the Third Chamber allowed that intervention.

50 On 17 June 2008, the Commission made an application for an order that there is no need to adjudicate in the main proceedings and waived its right to lodge a rejoinder. The reason for that application was the imminent adoption of the contested regulation.

51 On 28 July 2008, the French Republic lodged its observations on the Commission’s application for an order that there is no need to adjudicate. It requested that the current judicial proceedings be extended to the provisions of the contested regulation on the ground that they replace in identical form the contested provisions of Regulation No 727/2007, but state more reasons for them.

52 On 31 July 2008, the contested regulation was published in the Official Journal of the European Union. It entered into force on 29 September 2008.

53 On 28 August 2008, the Commission lodged at the Registry of the Court its observations on the French Republic’s request for extension of the current proceedings to the contested regulation. In those observations, the Commission submitted that that application was well founded.

54 By document lodged at the Registry of the Court on 19 September 2008, the French Republic made a new application for interim measures in which it claimed, in essence, that the President of the Court should order the suspension of operation of the contested regulation, in so far as it inserts, in Chapter A of Annex VII to Regulation No 999/2001, points 2.3(b)(iii), 2.3(d) and 4.

55 The United Kingdom did not lodge any observations on the request for extension of the current proceedings to the contested regulation by the time-limit of 25 September 2008 prescribed for that purpose.

56 By decision of 6 October 2008, the Court (Third Chamber) granted the French Republic’s application for the current proceedings to be extended to the provisions in issue, and allowed the lodging of additional submissions and pleas in law.

57 By order of 30 October 2008 in Case T‑257/07 R II France v Commission, not published in the ECR (the second order in France v Commission), the judge of the Court hearing applications for interim measures granted the French Republic’s second application for suspension of operation in this case and suspended the application of the regime in question until judgment has been given in the main action.

58 On 19 November 2008, the French Republic lodged its additional submissions at the Registry of the Court.

59 On 23 December 2008 and 16 January 2009, the Commission and the United Kingdom respectively submitted their observations on those additional submissions. In addition, on 23 December 2008, the Commission made an application to the Court for the present case to be decided under an expedited procedure in accordance with Article 76a of the Court’s Rules of Procedure.

60 On 21 January 2009, the French Republic submitted its observations on the Commission’s application for the case to be decided under an expedited procedure. The United Kingdom did not submit observations on the Commission’s application within the prescribed time.

61 By decision of 30 January 2009, the Court (Third Chamber) dismissed the Commission’s application for an expedited procedure but decided, in the special circumstances of this case, to give it priority in accordance with Article 55(2) of the Rules of Procedure. Pursuant to Article 14 of the Rules of Procedure and on the proposal of the Third Chamber, the Court decided, in accordance with Article 51 of those rules, to assign the case to a Chamber sitting in extended composition.

Forms of order sought by the parties

62 The French Republic claims that the Court should:

– annul the contested regulation in so far as it inserts in Chapter A of Annex VII to Regulation No 999/2001 points 2.3(b)(iii), 2.3(d), and 4;

– order the Commission to pay the costs.

63 The Commission, supported by the United Kingdom, contends that the Court should:

– dismiss the action as unfounded;

– order the French Republic to bear the costs.

Substance

1. Considerations of principle

Protection of human health

64 Article 152(1) EC provides that a high level of human health protection is to be ensured in the definition and implementation of all Community policies and activities. That 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, to that effect, order in Case C‑180/96 R United Kingdom v Commission [1996] ECR I‑3903, paragraph 93, and Case T‑158/03 Industrias Químicas del Vallés v Commission [2005] ECR II‑2425, paragraph 134).

65 Article 24a of Regulation No 999/2001 reflects the obligation contained in Article 152(1) EC by requiring that, when decisions are adopted in the context of that regulation, the level of protection of human health ensured in the Community is to be maintained, or if scientifically justified, increased.

Precautionary principle

Definition

66 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 (see Joined Cases T‑74/00, T‑76/00, T‑83/00 to T‑85/00, T‑132/00, T‑137/00 and T‑141/00 Artegodan and Others v Commission [2002] ECR II‑4945, paragraphs 183 and 184, and Case T‑392/02 Solvay Pharmaceuticals v Council [2003] ECR II‑4555, paragraph 121 and the case-law cited).

67 Moreover, as is made clear by Article 7(1) of Regulation No 178/2002, 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.

68 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 (see, to that effect, Case C‑180/96 United Kingdom v Commission [1998] ECR I‑2265, paragraph 99; Case C‑236/01 Monsanto Agricoltura Italia and Others [2003] ECR I‑8105, paragraph 111; Case C‑504/04 Agrarproduktion Staebelow [2006] ECR I‑679, paragraph 39; and Case T‑177/02 Malagutti-Vezinhet v Commission [2004] ECR II‑827, paragraph 54) or until the adverse health effects materialise (see, to that effect, Case T‑13/99 Pfizer Animal Health v Council [2002] ECR II‑3305, paragraphs 139 and 141, and Case T‑70/99 Alpharma v Council [2002] ECR II‑3495, paragraphs 152 and 154).

69 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. Although the first of those stages does not require further explanation, the two subsequent stages call for clarification.

Risk assessment

– Introduction

70 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 (see, to that effect, Pfizer Animal Health v Council, cited in paragraph 68 above, paragraph 149, and Alpharma v Council, cited in paragraph 68 above, paragraph 162).

– Scientific risk assessment

71 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 (Pfizer Animal Health v Council, cited in paragraph 68 above, paragraph 156, and Alpharma v Council, cited in paragraph 68 above, paragraph 169).

72 In its communication of 2 February 2000 on the precautionary principle (COM(2000) 1), the Commission defined those four components of a scientific risk assessment as follows (see Annex III):

‘Hazard identification means identifying the biological, chemical or physical agents that may have adverse effects …

Hazard characterisation consists of determining, in quantitative and/or qualitative terms, the nature and severity of the adverse effects associated with the causal agents or activity …

Appraisal of exposure consists of quantitatively or qualitatively evaluating the probability of exposure to the agent under study …

Risk characterisation corresponds to the qualitative and/or quantitative estimation, taking account of inherent uncertainties, of the probability, of the frequency and of the severity of the known or potential adverse environmental or health effects liable to occur. It is established on the basis of the three preceding [components] and closely depends on the uncertainties, variations, working hypotheses and conjectures made at each stage of the process.’

73 As a scientific process, the scientific risk assessment must be entrusted by the institution to scientific experts (Pfizer Animal Health v Council, cited in paragraph 68 above, paragraph 157, and Alpharma v Council, cited in paragraph 68 above, paragraph 170).

74 Moreover, in accordance with Article 6(2) of Regulation No 178/2002, 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 (see, to that effect, Pfizer Animal Health v Council, cited in paragraph 68 above, paragraph 158, and Alpharma v Council, cited in paragraph 68 above, paragraph 171).

75 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 (Pfizer Animal Health v Council, cited in paragraph 68 above, paragraphs 142 and 143; see also, to that effect, Case T‑229/04 Sweden v Commission [2007] ECR II‑2437, paragraph 161).

76 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 (see, to that effect, Solvay Pharmaceuticals v Council, cited in paragraph 66 above, paragraph 130). 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 (Pfizer Animal Health v Council, cited in paragraph 68 above, paragraphs 144 and 146). 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 (see, to that effect, Pfizer Animal Health v Council, cited in paragraph 68 above, paragraph 147).

77 Finally, it must be noted that 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 (see, to that effect, Pfizer Animal Health v Council, cited in paragraph 68 above, paragraphs 160 to 163, and Alpharma v Council, cited in paragraph 68 above, paragraphs 173 to 176).

– Determination of the level of risk

78 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 (see, to that effect, Case C‑473/98 Toolex [2000] ECR I‑5681, paragraph 45, and Pfizer Animal Health v Council, cited in paragraph 68 above, paragraphs 150 and 151).

79 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 (see, to that effect, Case C‑284/95 Safety Hi-Tech [1998] ECR I‑4301, paragraph 49). Moreover, those institutions may not take a purely hypothetical approach to risk and may not base their decisions on a ‘zero risk’ (Pfizer Animal Health v Council, cited in paragraph 68 above, paragraph 152).

80 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, to that effect, Pfizer Animal Health v Council, cited in paragraph 68 above, paragraph 153).

Risk management

81 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.

82 In accordance with Article 7(2) of Regulation No 178/2002, the provisional measures in question must be proportionate, non-discriminatory, transparent, and consistent with similar measures already taken (see, to that effect, Case C‑286/02 Bellio F.lli [2004] ECR I‑3465, paragraph 59).

83 Finally, it is for the competent authority to review the provisional measures in question within a reasonable period. It has been held that, 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 legislative initiative, to bring about an amendment to the rules in the light of the new information (Agrarproduktion Staebelow, cited in paragraph 68 above, paragraph 40).

Scope of judicial review

84 In matters concerning the common agricultural policy, the institutions enjoy a broad discretion regarding definition of the objectives to be pursued and choice of the appropriate means of action (see Pfizer Animal Health v Council, cited in paragraph 68 above, paragraph 166 and the case-law cited). 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.

85 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 (see Monsanto Agricoltura Italia and Others, cited in paragraph 68 above, paragraph 135; Case C‑425/08 Enviro Tech (Europe) [2009] ECR I‑10035, paragraph 47; and Pfizer Animal Health v Council, cited in paragraph 68 above, paragraph 166 and the case-law cited).

86 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 (see, to that effect, Case T‑380/94 AIUFFASS and AKT v Commission [1996] ECR II‑2169, paragraph 59, and Case T‑308/00 Salzgitter v Commission [2004] ECR II‑1933, paragraph 138). 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 (Enviro Tech, cited in paragraph 85 above, paragraph 47, and Case T‑289/03 BUPA and Others v Commission [2008] ECR II‑81, paragraph 221).

87 The abovementioned 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 (Case C‑525/04 P Spain v Lenzing [2007] ECR I‑9947, paragraph 57, and Case C‑405/07 P Netherlands v Commission [2008] ECR I‑8301, paragraph 55).

88 Moreover, it must be recalled that, 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. The Court of Justice has had occasion to specify that 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 (Case C‑269/90 Technische Universität München [1991] ECR I‑5469, paragraph 14; Joined Cases C‑258/90 and C‑259/90 Pesquerias De Bermeo and Naviera Laida v Commission [1992] ECR I‑2901, paragraph 26; Spain v Lenzing, cited in paragraph 87 above, paragraph 58; and Netherlands v Commission, cited in paragraph 87 above, paragraph 56).

89 Thus, it has already been held that 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 Pfizer Animal Health v Council, cited in paragraph 68 above, paragraph 172).

2. The sole plea in law, alleging breach of the precautionary principle

90 The French Republic raises a single plea, alleging breach of the precautionary principle by the Commission on account of the adoption of points 2.3(b)(iii), 2.3(d) and 4 of Chapter A of Annex VII to Regulation No 999/2001, as contained in the contested regulation (‘the contested measures’).

91 In support of that plea, the French Republic puts forward, firstly, arguments seeking to challenge the Commission’s risk assessment and, secondly, arguments seeking to challenge the Commission’s risk management.

3. Risk assessment

Introduction

92 As regards the Commission’s risk assessment, the French Republic claims, firstly, that the Commission did not take account of the scientific uncertainties surrounding the risk of transmissibility to humans of TSEs other than BSE, secondly, that the Commission did not have the reliability of ‘rapid tests’ scientifically evaluated, thirdly, that the Commission disregarded the scientific uncertainties as to the reliability of discriminatory tests and, fourthly, that the Commission did not have the risks arising from the contested measures assessed in good time.

The complaints alleging failure to take into account and misinterpretation of the scientific uncertainties surrounding the transmissibility to humans of TSEs other than BSE

93 The French Republic submits that the Commission failed to have regard to the precautionary principle at the risk assessment stage by disregarding or interpreting in a biased way the scientific uncertainties persisting with regard to the risk of transmissibility to humans of TSEs other than BSE.

94 The Commission asserts that there is a consensus among the scientific community and the international institutions on the lack of evidence capable of demonstrating that scrapie is transmissible to humans. There is no proof of an epidemiological or molecular link between the scrapie agent and TSEs affecting humans. The only TSE which is zoonotic is BSE.

95 The United Kingdom maintains, in essence, that the French Republic’s disagreement with the Commission’s assessment as to the transmissibility to humans of TSEs in ovine and caprine animals is not sufficient to demonstrate an error in that regard and that the Commission was not obliged to wait and see whether the scientific models in question would be almost perfectly representative and would correspond in the more or less near future. According to the United Kingdom, the EFSA opinions provided an entirely sufficient basis to act, as the Commission did.

96 In this case, in recitals 10 to 12 and 18 in the preamble to the contested regulation, the Commission set out its assessment regarding the risk of transmissibility to humans of TSEs affecting caprine or ovine animals other than BSE. In particular, taking as a basis EFSA’s opinion of 24 January 2008, it considered as follows:

‘It appears from EFSA’s clarifications that the biodiversity of the disease agents in ovine and caprine animals is an important element which does not make it possible to exclude transmissibility to humans and that that diversity increases the likelihood of one of the TSE agents being transmissible. However, EFSA acknowledges that there is no scientific evidence of any direct link between TSE in ovine and caprine animals, other than BSE, and TSE in humans. The EFSA viewpoint that transmissibility to humans of TSE agents in ovine or caprine animals cannot be excluded is based on experimental studies on human species barrier and animal models (primates and mice). Those models, however, do not take into account genetic characteristics of humans which have a major influence on relative susceptibility to prion diseases. They also have limitations when extrapolating results to natural conditions, in particular regarding how well they represent the human species barrier and the uncertainty of how well the experimental inoculation route employed represents exposure under natural conditions. On that basis, it may be considered that although a risk of transmissibility to humans of TSE agents in ovine or caprine animals cannot be excluded, that risk would be extremely low, taking into account the fact that the evidence of transmissibility is based on experimental models which do not represent the natural conditions related to the real human species barrier and the real routes of infection.’ (See recital 12 in the preamble to the contested regulation.)

97 It is thus apparent from recital 12 in the preamble to the contested regulation that the Commission expressly acknowledged that it was impossible to exclude any transmissibility to humans of TSEs affecting ovine and caprine animals, other than BSE, in the light of the biodiversity of the disease agents and of the results of experimental models. It follows that the French Republic is wrong in maintaining that the Commission overlooked the scientific uncertainties which persist as regards the risk of transmissibility to humans of those TSEs in the risk assessment which preceded the adoption of the contested measures.

98 However, the French Republic also maintains that the Commission interpreted the scientific opinions available to it in a biased way by considering that the risk of transmission to humans of an animal TSE other than BSE was extremely low.

99 In that regard, it is important to point out that, in the light of the Commission’s broad discretion in matters concerning the common agricultural policy and of the complex assessments which it is required to carry out in the context of its risk assessment, the review by the Courts of the European Union is limited in this case. It consists in establishing whether the Commission made a manifest error in assessing the scientific opinions available to it. Such an error presupposes that the evidence which must be adduced by the party alleging it is sufficient to make the factual assessments used in the contested regulation implausible (see paragraph 86 above).

100 In this case, the Commission inferred from EFSA’s opinions of 8 March 2007 and 24 January 2008 that the risk of transmissibility to humans of ovine or caprine TSEs other than BSE was extremely low.

101 In that regard, it must be pointed out that it is apparent from EFSA’s opinion of 8 March 2007 and that it is not disputed by the parties that there was no proof of an epidemiological or molecular link between classical or atypical scrapie and TSEs in humans.

102 Moreover, in its opinion of 24 January 2008, EFSA stated that it was, however, not possible to exclude transmissibility to humans of an ovine or caprine TSE other than BSE. In that regard, it stated that the lack of evidence of an epidemiological link did not necessarily demonstrate a lack of correlation between TSEs in animals and TSEs in humans, since this was in part due to the lack of data and to the lack of understanding of the biodiversity of animal and human TSEs. Thus, according to EFSA, the assumed lack of association between TSEs in humans and those in animals might be biased by, firstly, the lack of data on the historical real prevalence and distribution of small ruminant TSEs, at a time when only passive surveillance was performed, secondly, the lack of understanding of the true biodiversity of TSEs in small ruminants in terms of both classical and atypical scrapie agents, thirdly, the lack of understanding of the diversity of TSEs in humans due to the limited molecular and bioassay characterisation of those TSEs and to the number and spectrum of neurodegenerative diseases affecting humans and, fourthly, the predicted phenotype of disease that might arise if an animal TSE were transmitted to humans (see EFSA opinion of 24 January 2008, p. 4).

103 Furthermore, it is apparent from EFSA’s opinions of 8 March 2007 and 24 January 2008 that experimental studies did not make it possible to exclude transmissibility to humans of animal TSEs.

104 According to EFSA, in vitro transmissibility tests have demonstrated that the inherent ability of BSE and scrapie agents to affect humans following equivalent exposure is low (see EFSA opinion of 24 January 2008, p. 5). Moreover, laboratory tests with animal models have demonstrated the transmissibility of ovine and caprine TSEs other than classical BSE (see EFSA opinions of 8 March 2007, p. 6, and 24 January 2008, p. 4). EFSA referred inter alia to the transmission by the oral route of a classical scrapie agent in a hamster to a squirrel monkey, the transmission by the intra-cerebral route of classical scrapie from two distinct ovine sources to a macaque and a marmoset and the transmission of a TSE agent other than classical BSE to a mouse used as a model for the human M129 PRP gene.

105 However, the Commission was entitled to consider, without committing any manifest error of assessment, that those experimental models were imperfect. In its opinion of 24 January 2008, EFSA stated that those models did not allow the human gene PRNP polymorphism to be taken into account. However, that gene plays a major role in assessing susceptibility towards TSEs and it is conceivable that other genes may be influential in determining overall susceptibility to TSEs. Moreover, in its opinion of 8 March 2007, EFSA had found that route of exposure, dose, and cumulative exposures were considered to influence the ability of TSE agents to cross the human species barrier. However, the influence of those factors on the representativeness of the experimental models is not expressly indicated in EFSA’s opinions.

106 Thus, it is apparent from EFSA’s opinions that the scientific knowledge regarding transmissibility to humans of animal TSEs other than BSE was limited, since, at the time of the adoption of the contested measures, the only data to corroborate the ability of TSE agents other than BSE to infect humans were experimental models. However, those models did not reliably represent the human species barrier and exposure under natural conditions of humans to animal TSEs other than BSE. Those ways in which the experimental models lacked representativeness significantly affected their suitability for demonstrating possible damage to human health from an animal TSE other than BSE. The interaction between an animal TSE and the human species barrier, on the one hand, and the routes of exposure of humans to animal TSEs other than BSE, on the other, are important factors in assessing the risk of transmission to humans of animal TSEs other than BSE.

107 Moreover, although, in its Statement on the Potential Human Health Risk from Changes to Classical Scrapie Controls of February 2008, SEAC confirmed that a link between classical scrapie and human TSEs could not be ruled out, it nevertheless considered that that risk must be very low. According to it, the very low and relatively constant incidence of human TSE cases worldwide showed that there must be at least a substantial, if not complete, barrier to transmission of classical scrapie to humans.

108 In view of the limited and unrepresentative nature of the scientific evidence to support transmissibility of an ovine or caprine TSE other than BSE to humans at the time of adoption of the contested measures, the Commission was entitled to consider, without committing a manifest error of assessment, that the likelihood of an ovine or caprine TSE other than BSE being transmissible to humans was extremely low. Consequently, the conclusion, contained in recital 12 in the preamble to the contested regulation, that the risk of transmission to humans of such a TSE was extremely low is not vitiated by a manifest error of assessment.

109 The French Republic does not put forward any argument or submit any evidence to render implausible the Commission’s assessment that the risk of transmission to humans of animal TSEs other than BSE is extremely low. In particular, in so far as it considers that the limitations of the experimental models used for scrapie are the same as those of the models used for BSE, it must be observed that it stated at the hearing that the latter models were not sufficient on their own to establish transmissibility to humans of BSE. Without the molecular and epidemiological data for BSE, that transmissibility could therefore not have been established. Consequently, even though the experimental models used to assess the risk of transmissibility to humans of animal TSEs other than BSE were identical to those used to assess the risk of transmissibility to humans of BSE, that fact is not sufficient to characterise the extent of the risk. As the French Republic stated, that identity of the experimental models does not prove that the risk was low. On the other hand, the fact that, in this case, mere experimental models indicate that transmissibility to humans of animal TSEs other than BSE could not be excluded can be regarded as an indicator, on the basis of the knowledge existing at the time of the adoption of the contested measures, of the low degree of likelihood of transmissibility to humans of animal TSEs other than BSE.

The complaint alleging failure to consult scientific experts on the reliability of ‘rapid tests’

Preliminary considerations

110 The French Republic submits that the Commission breached the precautionary principle by failing to consult EFSA on the reliability of ‘rapid tests’. The Commission and the United Kingdom submit, in essence, that the Commission was sufficiently informed concerning the reliability of ‘rapid tests’ thanks to EFSA’s opinions of 17 May and 26 September 2005.

111 First of all, it must be recalled that the objective of ‘rapid tests’ is to detect the existence of a TSE, but not its type, namely BSE, classical scrapie or atypical scrapie, in small ruminants on the basis of tissue samples taken from dead animals.

112 Secondly, it must be observed that Regulation No 999/2001 provides that the prevention, control and eradication of TSEs are to take place, inter alia, within the framework of an annual programme for monitoring BSE and scrapie, which includes detection procedures using ‘rapid tests’. That monitoring involves subjecting to those tests a sample representative of dead animals for each region and season (see Annex I to Regulation No 270/2002). Those tests are listed in Annex X to Regulation No 999/2001 after being approved (see Article 6 of Regulation No 999/2001).

113 The purpose of EFSA’s opinions of 17 May and 26 September 2005 is to evaluate the performance of nine post-mortem ‘rapid tests’ on tissues from ovine and caprine animals, taking into account the opinion of AFSSA, and to give recommendations on the approval of those tests.

114 In its opinions of 17 May and 26 September 2005, EFSA evaluated inter alia the various ‘rapid tests’ in question in terms of their ‘diagnostic sensitivity’ (that is to say, the ability correctly to identify infected tissues of positive samples), their ‘diagnostic specificity’ (that is to say, the ability correctly to identify non-infected tissues) and their ‘analytical sensitivity’ (that is to say, the ability to identify a low concentration of prion in a dilution series). Eight of the nine ‘rapid tests’ in question achieved a satisfactory result as regards their application to tissues from the brainstem, also known as the ‘obex’. They achieved a percentage between 99.6 and 100 for ‘diagnostic sensitivity’ and ‘diagnostic specificity’. EFSA therefore recommended those eight tests to assess the prevalence of classical scrapie and BSE in sheep on the basis of brainstem samples. Finally, on the basis of limited scientific knowledge, it recommended that, in terms of ‘rapid tests’, goats should be treated in the same way as sheep.

115 Following those opinions, the eight ‘rapid tests’ recommended were set out in point 4 of Chapter C of Annex X to Regulation No 999/2001.

Use of ‘rapid tests’ for purposes other than epidemiological purposes

116 The French Republic complains, in essence, that the Commission considered that the evaluation of the reliability of ‘rapid tests’, set out in EFSA’s opinions of 17 May and 26 September 2005 and which had been carried out in the context of measures for the epidemiological monitoring of TSEs in small ruminants, was also valid in the context of the contested measures allowing the release for human consumption of meat from small ruminants in cases where the result of those tests was negative. At the hearing, it pointed out that the reliability requirement for a test to assess the prevalence of a disease within flocks of ovine and caprine animals could not be the same as that laid down for the purpose of deciding whether meat from ovine or caprine animals should be released for human consumption.

117 In that regard, it should be noted that EFSA had considered, in its opinion of 7 June 2007, that, although the sole objective of the ‘rapid testing’ programme at that time was epidemio-surveillance, it would have been possible to consider other uses for those tests in the future, such as certification of TSE-free flocks. Thus, EFSA expressly considered that ‘rapid tests’ could be used in contexts other than that of surveillance. Furthermore, if, as stated by EFSA, ‘rapid tests’ may be used to certify that the flock of small ruminants is not infected by a TSE, the Commission was entitled to infer from that, without committing a manifest error of assessment, that such certification would also be valid for meat originating from that flock intended for human consumption.

118 Moreover, it must be observed that effective epidemio-surveillance for TSEs in animals presupposes that TSE cases can be correctly identified. The effectiveness of that surveillance depends, inter alia, on the reliability of ‘rapid tests’.

119 In the opinions of 17 May and 26 September 2005, EFSA considered, for each of the ‘rapid tests’ that it was recommending, that they obtained satisfactory results in terms of ‘diagnostic sensitivity’ and ‘diagnostic specificity’ when applied to brainstem tissues from clinical, confirmed cases of cla