Judgment of the Court of First Instance (Third Chamber) of 11 September 2002. - Pfizer Animal Health SA v Council of the European Union. - Transfer of resistance to antibiotics from animals to humans - Directive 70/524/EEC - Regulation concerning the withdrawal of the authorisation of an additive in feedingstuffs - Admissibility - Article 11 of Directive 70/524/EEC - Manifest error of assessment - Precautionary principle - Risk assessment and risk management - Consultation of a scientific committee - Principle of proportionality - Legitimate expectations - Obligation to state reasons - Right to property - Misuse of powers. - Case T-13/99.



European Court reports 2002 Page II-03305



Summary

Parties

Grounds

Decision on costs

Operative part



Keywords

1. Actions for annulment - Natural or legal persons - Measures of direct and individual concern to them - Regulation providing for the withdrawal of authorisation to market certain additives in feedingstuffs, including virginiamycin, within the Community - Admissibility

(EC Treaty, Art. 173, fourth para. (now, after amendment, Art. 230, fourth para., EC); Council Regulation No 2821/98)

2. Agriculture - Common agricultural policy - Implementation - Requirements relating to protection of health to be taken into account - Application of the precautionary principle

(EC Treaty, Art. 130r(1) and (2) (now, after amendment, Art. 174(1) and (2) EC), and Art. 129(1), third para. (now, after amendment, Art. 152 EC))

3. Agriculture - Common agricultural policy - Discretion of the Community institutions - Possibility of adopting guidelines - Judicial review - Limits

4. Agriculture - Common agricultural policy - Use of virginiamycin as an additive in feedingstuffs - Scientific uncertainty as to the existence or extent of risks to human health - Application of the precautionary principle - Scope - Limits

(EC Treaty, Art. 130r(1) and (2) (now, after amendment, Art. 174(1) and (2) EC))

5. Agriculture - Common agricultural policy - Scientific risk assessment - Requirement for a high level of human health protection - Scope

(EC Treaty, Art. 129(1), first para. (now, after amendment, Art. 152 EC))

6. Agriculture - Common agricultural policy - Discretion of the Community institutions - Extent - Judicial review - Limits

7. Agriculture - Common agricultural policy - Application of the precautionary principle - Scope - Limits - Observance of guarantees afforded by the Community legal order in administrative proceedings

8. Community law - Procedural law - Procedure which must culminate in a decision or legislative measure - Procedural implications of an expert opinion - Consultation of a scientific committee - Respective roles of the scientific committee and the competent Community institution

9. Agriculture - Common agricultural policy - Power of the Community institutions - Ability to withdraw authorisation from an additive in feedingstuffs without first having obtained a scientific opinion from the competent scientific committee - Exceptional nature

10. Actions for annulment - Contested measure - Assessment of legality on the basis of the information available at the time when the measure was adopted

(EC Treaty, Art. 173 (now, after amendment, Art. 230 EC))

11. Agriculture - Common agricultural policy - Regulation providing for the withdrawal of authorisation to market certain additives in feedingstuffs, including virginiamycin, within the Community - Discretion of the Community institutions

(Council Regulation No 2821/98; Council Directive 70/524, Art. 3a(e))

12. Community law - Principles - Proportionality - Acts of the institutions - Proportional character - Criteria for assessment - Discretion of Community legislature in relation to the common agricultural policy - Judicial review - Limits

(EC Treaty, Arts 40 and 43 (now, after amendment, Arts 34 EC and 37 EC))

13. Agriculture - Common agricultural policy - Absence, at international level, of Community measures against the import of meat produced using virginiamycin as a growth promoter - Invalidity of ban on use of that product at Community level - Not invalid

14. Community law - Principles - Fundamental rights - Freedom to pursue a trade or profession - Restrictions introduced for the purposes of the protection of public health - Whether permissible

(Council Regulation No 2821/98)

15. Agriculture - Common agricultural policy - No action taken against the use of substances other than virginiamycin - Breach of the principle of non-discrimination - None

16. Community law - Principles - Rights of the defence - Observance of the rights of the defence in legislative procedures - Limits

Summary

$$1. A regulation is of individual concern to a person where, in the light of the specific circumstances of the case concerned, it adversely affects a particular right on which that person could rely.

Furthermore, by terminating or, at the least, suspending the procedure which had been opened, at the request of an economic operator, for the purposes of obtaining a new authorisation of virginiamycin as an additive in feedingstuffs, and in the course of which that operator had the benefit of procedural guarantees, Regulation No 2821/98 providing for the withdrawal of the authorisation to market certain additives in feedingstuffs, including virginiamycin, within the Community affects that operator by reason of a legal and factual situation which differentiates it from all other persons. That fact is also such as to distinguish it for the purposes of the fourth paragraph of Article 173 of the Treaty (now, after amendment, the fourth paragraph of Article 230 EC).

( see paras 98-100, 104 )

2. In accordance with Article 130r(2) of the Treaty (now, after amendment, Article 174(2) EC), the precautionary principle is one of the principles on which Community policy on the environment is based. The principle also applies where the Community institutions take, in the framework of the common agricultural policy, measures to protect human health. It is apparent from Article 130r(1) and (2) of the Treaty that Community policy on the environment is to pursue the objective inter alia of protecting human health, that the policy, which aims at a high level of protection, is based in particular on the precautionary principle and that the requirements of the policy must be integrated into the definition and implementation of other Community policies. Furthermore, as the third subparagraph of Article 129(1) of the Treaty (now, after amendment, Article 152 EC) provides, and in accordance with settled case-law, health protection requirements form a constituent part of the Community's other policies and must therefore be taken into account when the common agricultural policy is implemented by the Community institutions.

( see para. 114 )

3. The Community institutions may lay down for themselves guidelines for the exercise of their discretionary powers by way of measures not provided for in Article 189 of the Treaty (now Article 249 EC), in particular by communications, provided that they contain directions on the approach to be followed by the Community institutions and do not depart from the Treaty rules. In such circumstances, the Community judicature ascertains, applying the principle of equal treatment, whether the disputed measure is consistent with the guidelines that the institutions have laid down for themselves by adopting and publishing such communications.

( see para. 119 )

4. Where there is scientific uncertainty as to the existence or extent of risks to human health, the Community institutions may, by reason of the precautionary principle, take protective measures without having to wait until the reality and seriousness of those risks become fully apparent.

It follows, first, that as a result of the precautionary principle, as enshrined in Article 130r(2) of the Treaty (now, after amendment, Article 174(2) EC), the Community institutions were entitled to take a preventive measure regarding the use of virginiamycin as an additive in feedingstuffs, even though, owing to existing scientific uncertainty, the reality and the seriousness of the risks to human health associated with that use were not yet fully apparent. A fortiori, the Community institutions were not required, for the purpose of taking preventive action, to wait for the adverse effects of the use of the product as a growth promoter to materialise. Thus, in a situation in which the precautionary principle is applied, which by definition coincides with a situation in which there is scientific uncertainty, a risk assessment cannot be required to provide the Community 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.

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. It follows from the Community Courts' interpretation of the precautionary principle 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.

The taking of measures, even preventive ones, on the basis of a purely hypothetical risk is particularly inappropriate in the matter of additives in feedingstuffs. In such matters a zero risk does not exist, since it is not possible to prove scientifically that there is no current or future risk associated with the addition of antibiotics to feedingstuffs. Moreover, that approach is even less appropriate in a situation in which the legislation already makes provision, as one of the possible ways of giving effect to the precautionary principle, for a procedure for prior authorisation of the products concerned.

The precautionary principle can therefore apply only in situations in which there is a risk, notably to human health, which, although it is not founded on mere hypotheses that have not been scientifically confirmed, has not yet been fully demonstrated.

In such a situation, risk thus constitutes a function of the probability that use of a product or a procedure will adversely affect the interests safeguarded by the legal order.

Consequently, the purpose of a risk assessment is to assess the degree of probability of a certain product or procedure having adverse effects on human health and the seriousness of any such adverse effects.

( see paras 139-148 )

5. In the assessment of risk, it is for the Community institutions to determine the level of risk - i.e. the critical probability threshold for adverse effects on human health and for the seriousness of those possible effects - which in their judgment is no longer acceptable for society and above which it is necessary, in the interests of protecting human health, to take preventive measures in spite of any existing scientific uncertainty.

Although they may not take a purely hypothetical approach to risk and may not base their decisions on a zero-risk, the Community institutions must nevertheless take account of their obligation under the first subparagraph of Article 129(1) of the Treaty (now, after amendment, Article 152 EC) to ensure a high level of human health protection, which, to be compatible with that provision, does not necessarily have to be the highest that is technically possible.

The level of risk deemed unacceptable 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 human health 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.

In matters relating to additives in feedingstuffs the Community institutions are responsible for carrying out complex technical and scientific assessments. In such circumstances a scientific risk assessment must be carried out before any preventive measures are taken.

A scientific risk assessment is commonly defined, at both international level and Community level, as a scientific process consisting in the identification and characterisation of a hazard, the assessment of exposure to the hazard and the characterisation of the risk.

The competent public authority must, in compliance with the relevant provisions, entrust a scientific risk assessment to experts who, once the scientific process is completed, will provide it with scientific advice.

Scientific advice is of the utmost importance at all stages of the drawing up and implementation of new legislation and for the execution and management of existing legislation. The duty imposed on the Community institutions by the first subparagraph of Article 129(1) of the Treaty to ensure a high level of human health protection 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.

Thus, in order to fulfil its function, scientific advice on matters relating to consumer health must, in the interests of consumers and industry, be based on the principles of excellence, independence and transparency.

When the precautionary principle is applied, it may prove impossible to carry out a full risk assessment because of the inadequate nature of the available scientific data. A full risk assessment may require long and detailed scientific research. Unless the precautionary principle is to be rendered nugatory, the fact that it is impossible to carry out a full scientific risk assessment does not prevent the competent public authority from taking preventive measures, at very short notice if necessary, when such measures appear essential given the level of risk to human health which the authority has deemed unacceptable for society.

The competent public authority must therefore weigh up its obligations and decide either to wait until the results of more detailed scientific research become available or to act on the basis of the scientific information available. Where measures for the protection of human health are concerned, the outcome of that balancing exercise will depend, account being taken of the particular circumstances of each individual case, on the level of risk which the authority deems unacceptable for society.

Where experts carry out a scientific risk assessment, the competent public authority must be given 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. Consequently, if it is not to adopt arbitrary measures, which cannot in any circumstances be rendered legitimate by the precautionary principle, the competent public authority must ensure that any measures that it takes, even preventive measures, are based on as thorough a scientific risk assessment as possible, account being taken of the particular circumstances of the case at issue. Notwithstanding the existing scientific uncertainty, the scientific risk assessment must enable the competent public authority to ascertain, on the basis of the best available scientific data and the most recent results of international research, whether matters have gone beyond the level of risk that it deems acceptable for society. That is the basis on which the authority must decide whether preventive measures are called for and, should that be the case, which measures appear to it to be appropriate and necessary to prevent the risk from materialising.

( see paras 151-163 )

6. In matters concerning the common agricultural policy the Community institutions enjoy a broad discretion regarding definition of the objectives to be pursued and choice of the appropriate means of action. In that regard, review by the Community judicature of the substance of the relevant act must be confined to examining whether the exercise of such discretion is vitiated by a manifest error or a misuse of powers or whether the Community institutions clearly exceeded the bounds of their discretion.

The Community institutions enjoy a broad discretion, in particular when determining the level of risk deemed unacceptable for society.

Where a Community authority is required to make complex assessments in the performance of its duties, its discretion also applies, to some extent, to the establishment of the factual basis of its action.

It follows that judicial review of the Community institutions' performance of their duty must be limited. The Community judicature is not entitled to substitute its assessment of the facts for that of the Community institutions, on which the Treaty confers sole responsibility for that duty. Instead, it must confine itself to ascertaining whether the exercise by the institutions of their discretion in that regard is vitiated by a manifest error or a misuse of powers or whether the institutions clearly exceeded the bounds of their discretion.

( see paras 166-169 )

7. Under the precautionary principle the Community institutions are entitled, in the interests of human health to adopt, on the basis of as yet incomplete scientific knowledge, protective measures which may seriously harm legally protected positions, and they enjoy a broad discretion in that regard.

In such circumstances, the guarantees conferred by the Community legal order in administrative proceedings are of even more fundamental importance. Those guarantees include, in particular, the duty of the competent institution to examine carefully and impartially all the relevant aspects of the individual case.

It follows 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 paras 170-172 )

8. Against a legislative background in which the Community institution is not bound by the scientific opinion given by the competent scientific committee, the role played by a committee of experts, such as the Scientific Committee for Animal Nutrition, in a procedure designed to culminate in a decision or a legislative measure, is restricted, as regards the answer to the questions which the competent institution has asked it, to providing a reasoned analysis of the relevant facts of the case in the light of current knowledge about the subject, in order to provide the institution with the factual knowledge which will enable it to take an informed decision.

However, the competent Community institution must, first, prepare for the committee of experts the factual questions which need to be answered before it can adopt a decision and, second, assess the probative value of the opinion delivered by the committee. In that regard, the Community institution must ensure that the reasoning in the opinion is full, consistent and relevant.

To the extent to which the Community institution opts to disregard the opinion, it must provide specific reasons for its findings by comparison with those made in the opinion and its statement of reasons must explain why it is disregarding the latter. The statement of reasons must be of a scientific level at least commensurate with that of the opinion in question.

( see paras 197-199 )

9. Even if, under the relevant legislation, the Community institutions are able to withdraw authorisation from an additive without first having obtained a scientific opinion from the competent scientific committees, it must be held that it is only in exceptional circumstances and where there are adequate guarantees of scientific objectivity that the Community institutions may, when they are required to assess particularly complex facts of a technical or scientific nature, adopt a preventive measure withdrawing authorisation from an additive without obtaining an opinion from the scientific committee set up for that purpose at Community level on the relevant scientific material.

( see paras 265, 270 )

10. In an action for annulment under Article 173 of the Treaty (now, after amendment, Article 230 EC), the assessment made by the Community institutions can be challenged only if it appears incorrect in the light of the elements of fact and law which were available to them at the time when the contested measure was adopted.

( see para. 324 )

11. In an action for annulment of Regulation No 2821/98 providing for withdrawal of the authorisation to market certain additives in feedingstuffs, including virginiamycin, in the Community, it is not for the Community Courts to assess the merits of either of the scientific points of view argued before them and to substitute their assessment for that of the Community institutions, on which the Treaty confers sole responsibility in that regard. Since the Community institutions could reasonably take the view that they had a proper scientific basis for a link between the use of virginiamycin as an additive in feedingstuffs and the development of streptogramin resistance in humans, the mere fact that there were scientific indications to the contrary does not establish that they exceeded the bounds of their discretion in finding that there was a risk to human health.

It is clear, on the contrary, that the Community institutions could properly find that there were serious reasons concerning human health, within the meaning of Article 3a(e) of Directive 70/524 concerning additives in feedingstuffs, for restricting streptogramins to medical use.

( see paras 393, 402 )

12. The principle of proportionality, which is one of the general principles of Community law, requires that measures adopted by Community institutions should not exceed the limits of what is appropriate and necessary in order to attain the legitimate objectives pursued by the legislation in question, and where there is a choice between several appropriate measures, recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims pursued.

However, in matters concerning the common agricultural policy, the Community legislature has a discretionary power which corresponds to the political responsibilities given to it by Articles 40 and 43 of the Treaty (now, after amendment, Articles 34 EC and 37 EC). Consequently, the legality of a measure adopted in that sphere can be affected only if the measure is manifestly inappropriate, regard being had to the objective which the competent institution is seeking to pursue.

( see paras 411-412 )

13. The fact that the Community institutions have not adopted measures at international level against imports of meat produced using virginiamycin as a growth promoter cannot of itself affect the validity of the ban on the use of virginiamycin within the Community. It would rather have to be established that in the absence of any such action the contested regulation was in itself a manifestly inappropriate means of achieving the objective pursued.

( see para. 433 )

14. The importance of the objective pursued by Regulation No 2821/98 providing for withdrawal of the authorisation to market certain additives in feedingstuffs, including virginiamycin, within the Community, i.e. the protection of human health, may justify adverse economic consequences, and even substantial adverse consequences, for certain traders. The protection of public health, which the regulation is intended to guarantee, must take precedence over economic considerations.

Furthermore, although the freedom to pursue a trade or business forms part of the general principles of Community law, that principle does not amount to an unfettered prerogative but must be viewed in the light of its social function. Consequently, it may be restricted, provided that the restrictions imposed in fact correspond to objectives of general interest pursued by the Community and do not, in relation to the aim pursued, constitute a disproportionate and intolerable interference which would affect the very substance of the right so guaranteed.

( see paras 456-457 )

15. The principle of non-discrimination, which constitutes a fundamental principle of law, prohibits comparable situations from being treated differently or different situations from being treated in the same way, unless such difference in treatment is objectively justified. The lack of any action against the use of other substances, even if assumed to be unlawful, could not in itself affect the lawfulness of the ban on virginiamycin. Even if it were established that the authorisations of other products should also be withdrawn, it would not however be proved that the regulation was unlawful for breach of the principle of non-discrimination, in so far as there is no equality in illegality, since the principle of non-discrimination does not found an entitlement to the non-discriminatory application of unlawful treatment.

( see paras 478-479 )

16. The right to be heard in an administrative procedure taken against a specific person, which must be observed, even in the absence of any rules governing the procedure, cannot be transposed to a legislative procedure leading, as in the present case, to the adoption of a measure of general application. The fact that an economic operator is directly and individually concerned by the contested regulation does not alter that finding.

( see para. 487 )

Parties

In Case T-13/99,

Pfizer Animal Health SA, established in Louvain-la-Neuve (Belgium), represented by I.S. Forrester QC, M. Powell, Solicitor, E. Wright, Barrister, and W. van Lembergen, lawyer, instructed by S.J. Gale-Batten, Solicitor, with an address for service in Luxembourg,

applicant,

supported by

Asociación nacional de productores de ganado porcino (Anprogapor), having its registered office in Madrid (Spain),

and

Asociación española de criadores de vacuno de carne (Asovac), having its registered office in Barcelona (Spain),

represented by J. Folguera Crespo, A. Gutiérrez Hernández, J. Massaguer Fuentes and E. Navarro Varona, lawyers, with an address for service in Luxembourg,

and by

Fédération européenne de la santé animale (Fedesa), having its registered office in Brussels (Belgium),

and

Fédération européenne des fabricants d'adjuvants pour la nutrition animale (Fefana), having its registered office in Brussels (Belgium),

represented by D. Waelbroeck and D. Brinckman, lawyers, with an address for service in Luxembourg,

interveners,

v

Council of the European Union, represented by J. Carbery, M. Sims and F.P. Ruggeri Laderchi, acting as Agents,

defendant,

supported by

Commission of the European Communities, represented by P. Oliver, T. Christoforou and K. Fitch, acting as Agents, with an address for service in Luxembourg,

by

Kingdom of Denmark, represented by J. Molde, acting as Agent, N. Holst-Christensen and S. Ryom, with an address for service in Luxembourg,

by

Kingdom of Sweden, represented by A. Kruse and L. Nordling, acting as Agents, with an address for service in Luxembourg,

by

Republic of Finland, represented by H. Rotkirch, T. Pynnä and E. Bygglin, acting as Agents, with an address for service in Luxembourg,

and by

United Kingdom of Great Britain and Northern Ireland, represented by R. Magrill, acting as Agent, with M. Hoskins, Barrister, with an address for service in Luxembourg,

interveners,

APPLICATION for annulment of Council Regulation (EC) No 2821/98 of 17 December 1998 amending, as regards withdrawal of the authorisation of certain antibiotics, Directive 70/524/EEC concerning additives in feedingstuffs (OJ 1998 L 351, p. 4),

THE COURT OF FIRST INSTANCE OF THE EUROPEAN COMMUNITIES

(Third Chamber),

composed of: J. Azizi, President, K. Lenaerts and M. Jaeger, Judges,

Registrar: F. Erlbacher, Legal Secretary,

having regard to the written procedure and further to the hearing on 2 July 2001,

gives the following

Judgment

Grounds

Legal framework

I - The Act of Accession

1 Article 151(1) of the Act concerning the conditions of accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden and the adjustments to the Treaties on which the European Union is founded (OJ 1994 C 241, p. 21, `the Act of Accession') provides as follows:

`The acts listed in Annex XV to this Act shall apply in respect of the new Member States under the conditions laid down in that Annex.'

2 Under Annex XV, Title VII, point E1(4) of the Act of Accession, the Kingdom of Sweden may maintain in force until 31 December 1998 its pre-accession legislation with regard to the restriction on, or prohibition of, the use in feedingstuffs of additives belonging to the group of antibiotics. Before that date, `a decision shall be taken in accordance with the procedure laid down in Article 7 of Directive 70/524/EEC on requests for adaptation presented by the Kingdom of Sweden; those requests shall be accompanied by a detailed scientific statement of reasons.'

II - The Community rules on additives in feedingstuffs

A - General description

3 On 23 November 1970 the Council adopted Directive 70/524/EEC concerning additives in feedingstuffs (OJ, English Special Edition 1970 (III), p. 840). This Directive laid down the Community rules applying to the authorisation, and withdrawal of authorisation, of additives for incorporation in feedingstuffs.

4 Directive 70/524 has been amended and supplemented on several occasions. In particular, it was heavily amended by Council Directive 84/587/EEC of 29 November 1984 (OJ 1984 L 319, p. 13) and by Council Directive 96/51/EC of 23 July 1996 (OJ 1996 L 235, p. 39). It was supplemented inter alia by the decisions cited at paragraphs 24 to 26 and 28 below.

5 Directive 96/51 introduced new rules for authorisation, and withdrawal of authorisation, of additives in feedingstuffs (`the new rules') in place of the rules which had applied until then (`the original rules').

6 To bring about the transition from the original rules to the new rules, which took effect on 1 October 1999, Directive 96/51 introduced a number of rules applicable from 1 April 1998 to certain additives authorised under the original rules, including antibiotics (`the transitional rules'). For this purpose, Article 2(1)(a) of Directive 96/51 provided that the Member States were to bring into force the laws, regulations and administrative provisions necessary to comply with certain provisions of the directive by 1 April 1998.

B - Definition of additives in feedingstuffs

7 Under the original rules additives were defined in Article 2 of Directive 70/524, as amended by Directive 84/587, as `substances ... which, when incorporated in feedingstuffs, are likely to affect their characteristics or livestock production'.

8 According to recital 3 of the preamble to Directive 96/51, it was considered necessary, under the new rules, to draw a distinction between `additives which are widely used and present no particular dangers for the manufacture of feedingstuffs' and `high technology additives with a very specific composition for which the person responsible for putting them into circulation must receive authorisation, in order to avoid copies which might not be in conformity and might therefore be unsafe'. Effect is given to that distinction by Article 2 of Directive 70/524, as amended by Article 1(3)(i) of Directive 96/51. Article 2, as amended, contains the following definitions:

`(a) "additives": substances or preparations used in animal nutrition in order to:

- affect favourably the characteristics of feed materials or of compound feedingstuffs or of animal products; or

- satisfy the nutritional needs of animals or improve animal production, in particular by affecting the gastro-intestinal flora or the digestibility of feedingstuffs; or

- introduce into nutrition elements conducive to attaining particular nutritional objectives or to meeting the specific nutritional needs of animals at a particular time; or

- prevent or reduce the harmful effects caused by animal excretions or improve the animal environment;

(aa) "micro-organisms": micro-organisms forming colonies;

(aaa) "additives subject to authorisation linked to the person responsible for putting them into circulation": the additives listed in Part I of Annex C;

(aaaa) "other additives": additives not subject to authorisation linked to the person responsible for putting them into circulation and referred to in Part II of Annex C.'

9 It is apparent from Annex C to Directive 70/524, as inserted by Article 1(20) of Directive 96/51, that all additives belonging to the group of antibiotics or the group of growth promoters fall within the class of additives covered by Article 2(aaa) and are therefore subject to authorisation linked to the person responsible for putting them into circulation.

C - The rules on authorisation and withdrawal of authorisation of antibiotics used as additives in feedingstuffs

1. The rules on authorisation of additives

10 Under the original rules, Article 3(1) of Directive 70/524, which was repealed by Directive 96/51, provided that `Member States shall provide that, as regards feedingstuffs, only those additives listed in Annex I which comply with this Directive may be marketed and that they may be incorporated in feedingstuffs only subject to the requirements set out in that Annex ...'. However, under Article 4(1)(a) of Directive 70/524, repealed by Directive 96/51, the Member States could, by way of derogation from Article 3(1) and subject to certain conditions set out in Directive 70/524, authorise the marketing and use, within their own territory, of additives listed in Annex II to that Directive.

11 Under the new rules (Article 3 of Directive 70/524 as amended by Directive 96/51), only additives which have a Community authorisation granted under a Commission regulation may be put into circulation. Under the new Article 3a of Directive 70/524, authorisation of an additive is given inter alia if:

`...

(e) for serious reasons concerning human or animal health its use must not be restricted to medical or veterinary purposes.'

12 Article 4 of Directive 70/524, as amended by Directive 96/51, lays down the procedure for obtaining Community authorisation of an additive under both the new rules and the transitional rules.

13 Article 9 of Directive 70/524, as amended by Directive 96/51, provides that `[a]dditives as referred to in Article 2(aaa) which meet the conditions laid down in Article 3a shall be authorised and included in Chapter I of the list referred to in Article 9t(b)'. Chapter I includes additives whose authorisation is linked to a person responsible for putting them into circulation and is granted for a period of 10 years. Under the new Article 9b, authorisation is to be renewable for 10-year periods.

14 Furthermore, Article 2(k) of Directive 70/524, as amended by Directive 96/51, defines `putting into circulation' and `circulation' as:

`the holding of products for the purposes of sale, including offering for sale, or any other form of transfer, whether free or not, to third parties, and the sale and other forms of transfer themselves'.

15 Article 2(1) of Directive 70/524, as amended by Directive 96/51, defines `person responsible for putting into circulation' as:

`the natural or legal person who has responsibility for the conformity of the additive which has been granted Community authorisation and for putting it into circulation'.

16 Under the new Article 9c(1) of Directive 70/524, `the scientific data and other information in the initial dossier submitted for the purpose of the first authorisation may not be used for the benefit of other applicants for a period of 10 years'. The reasons for that restriction are given as follows in recital 14 of the preamble to Directive 96/51: `[w]hereas the search for new additives [referred to in Article 2(aaa)] requires costly investment; whereas protection for a period fixed at 10 years should therefore be afforded to scientific data or information included in the dossier on the basis of which the first authorisation is granted'.

2. The withdrawal of authorisation of an additive

17 The procedure for withdrawing the authorisation of an additive is the same under the new rules as under the old ones and is laid down in Article 23 of Directive 70/524. However, under Article 11 of Directive 70/524, Member States may take safeguard measures in respect of an additive. In that case, the procedure for withdrawing the authorisation of an additive affected by such a safeguard measure is laid down in Article 24 of Directive 70/524.

18 Article 11 of Directive 70/524, as amended by Article 1(1) of Directive 84/587 and Article 1(7) of Directive 96/51, provides that:

`1. Where a Member State, as a result of new information or of a reassessment of existing information made since the provisions in question were adopted, has detailed grounds for establishing that the use of one of the additives authorised or its use in conditions which may be specified constitutes a danger to animal or human health or the environment although it complies with the provisions of this Directive, that Member State may temporarily suspend or restrict application of the provisions in question in its territory. It shall immediately inform the other Member States and the Commission thereof, giving reasons for its decision.

2. The Commission shall, as soon as possible, examine the grounds cited by the Member State concerned and consult the Member States within the Standing Committee for Feedingstuffs; it shall then deliver its opinion without delay and take the appropriate measures.

3. Should the Commission consider that amendments to the Directive are necessary in order to mitigate the difficulties mentioned in paragraph 1 and to ensure the protection of animal or human health or the environment, it shall initiate the procedure laid down in Article 24 with a view to adopting these amendments; the Member State which has adopted safeguard measures may in that event retain them until the amendments enter into force.'

19 Article 24 of Directive 70/524, as inserted by Article 1(1) of Directive 84/587 and most recently amended by Annex I to the Act of Accession, provides as follows;

`1. Where the procedure laid down in this Article is to be followed, matters shall be referred to the [Standing] Committee [for Feedingstuffs] without delay by the chairman, either on his own initiative or at the request of a Member State.

2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion within two days. The opinion shall be delivered by the majority laid down in Article 148(2) of the [EC] Treaty [(now Article 205(2) EC)] in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that article. The Chairman shall not vote.

3. The Commission shall adopt the measures and implement them forthwith where they are in accordance with the opinion of the Committee. Where they are not in accordance with the opinion of the Committee or if no opinion is delivered, the Commission shall without delay propose to the Council the measures to be adopted. The Council shall adopt the measures by a qualified majority.

If the Council has not adopted any measures within 15 days of the proposal being submitted to it, the Commission shall adopt the proposed measures and implement them forthwith, except where the Council has voted by a simple majority against such measures.'

3. The transitional rules

20 For additives such as antibiotics, which were authorised under the original rules and whose authorisation Directive 96/51 thereafter linked to the person responsible for putting them into circulation, Articles 9g, 9h and 9i of Directive 70/524, introduced by Directive 96/51, provide for a transitional period during which those additives remain provisionally authorised but must be the subject of a new authorisation under the new rules.

21 Article 9g of Directive 70/524 provides that:

`1. Additives as referred to in Article 2(aaaa) included in Annex I before 1 January 1988 shall be provisionally authorised as from 1 April 1998 and transferred to Chapter I of Annex B with a view to their re-evaluation as additives linked to a person responsible for putting them into circulation.

2. With a view to their re-evaluation, the additives as referred to in paragraph 1 must, before 1 October 1998, be the subject of new applications for authorisation; such applications, accompanied by the monographs and the identification notes provided for in Articles 9n and 9o respectively, shall be addressed by the person responsible for the dossier on the basis of which the former authorisation was granted or by his successor or successors, via the Member State acting as rapporteur, to the Commission, sending copies to the other Member States, which shall acknowledge receipt thereof.

3. In accordance with the procedure laid down in Article 23, provisional authorisation of the additives shall be withdrawn through the adoption of a Regulation and they shall be deleted from the list in Chapter I of Annex B before 1 October 1999:

(a) if the documents prescribed in paragraph 2 are not submitted within the time allowed or

(b) if, after scrutiny of the documents, it is established that the monographs and identification notes are not in accordance with the data in the dossier on the basis of which the original authorisation was given.

4. Member States shall ensure that the person responsible for putting an additive as referred to in paragraph 1 into circulation submits, as provided for in Article 4 and not later than 30 September 2000, the dossier referred to in Article 4 with a view to re-evaluation. Where he fails to do so, the authorisation of the additive in question shall be withdrawn through the adoption of a regulation in accordance with the procedure laid down in Article 23 and it shall be deleted from the list in Chapter I of Annex B.

5. The Commission shall take all necessary measures to ensure that re-evaluation of the dossiers referred to in paragraph 4 is completed no later than three years after the dossier is submitted.

In accordance with the procedure laid down in Article 23, authorisations of the additives referred to in Article 1:

(a) shall be withdrawn and they shall be deleted from the list in Chapter I of Annex B through the adoption of a regulation, or

(b) shall be replaced by authorisations linked to the person responsible for putting them into circulation for a period of 10 years through the adoption of a regulation taking effect no later than 1 October 2003 and included in Chapter I of the list referred to in Article 9t(b).

...'

22 Article 9h contains provisions similar to those of Article 9g for additives included in Annex I to Directive 70/524 after 31 December 1987. These products are to be transferred to Chapter II of Annex B to the Directive, as amended by Directive 96/51. However, unlike the additives transferred to Chapter I of Annex B pursuant to Article 9g, which are subject to re-evaluation and in respect of which authorisation linked to the person responsible for putting them into circulation may be granted no later than 1 October 2003, the additives included in Chapter II of Annex B to Directive 96/51 pursuant to Article 9h must be authorised - or, where appropriate, prohibited - no later than 1 October 1999, without prior re-evaluation. Where authorisation is given, those additives are included for a period of 10 years in Chapter I of the list referred to in Article 9t(b), which was mentioned above.

23 For additives included in Annex II to Directive 70/524 before 1 April 1998, Article 9i contains provisions similar to those of Article 9h. Those additives are to be transferred to Chapter III of Annex B to the Directive, as amended by Directive 96/51. The period of provisional authorisation of those additives may not, however, exceed five years, account being taken of the period of inclusion in Annex II.

D - The `Standing Committee', the Scientific Committee for Animal Nutrition and the Scientific Steering Committee

24 The Standing Committee for Feedingstuffs (`the Standing Committee'), which is referred to in Article 24 of Directive 70/524 cited at paragraph 19 above, was established by Council Decision 70/372/EEC of 20 July 1970 setting up a Standing Committee for Feedingstuffs (OJ, English Special Edition 1970 (II), p. 534). It consists of representatives of the Member States with a representative of the Commission as chairman.

25 By Decision 76/791/EEC of 24 September 1976 establishing a Scientific Committee for Animal Nutrition (OJ 1976 L 279, p. 35), replaced by Commission Decision 97/579/EC of 23 July 1997 setting up Scientific Committees in the field of consumer health and food safety (OJ 1997 L 237, p. 18), the Commission appointed a Scientific Committee for Animal Nutrition (`SCAN'). Article 2(1) and (3) of Decision 97/579 provides as follows:

`1. The Scientific Committees shall be consulted in the cases laid down by Community legislation. The Commission may also decide to consult them on other questions of particular relevance to consumer health and food safety.

...

3. At the Commission's request, the Scientific Committees shall provide scientific advice on matters relating to consumer health and food safety ... .'

26 The Annex to Decision 97/579 defines the field of competence of SCAN as `[s]cientific and technical questions concerning animal nutrition, its effect on animal health, on the quality and health of products of animal origin, and concerning the technologies applied to animal nutrition'.

27 In addition, Article 8(1) of Directive 70/524, as amended by Directive 96/51, provides as follows:

`The Scientific Committee for Animal Nutrition established by [Decision 76/791] shall be responsible for assisting the Commission, at the latter's request, on all scientific questions relating to the use of additives in animal nutrition.'

28 Finally, by Decision 97/404/EC of 10 June 1997 establishing a Scientific Steering Committee (OJ 1997 L 169, p. 85; `the SSC'), the Commission appointed such a Committee.

Background to the proceedings

I - Scientific background to the case as at the time when the contested regulation, Regulation (EC) No 2821/98, was adopted

29 Defined in general terms, an antibiotic is a substance of biological or synthetic origin, specifically acting at an essential stage of the metabolism of bacteria (antibacterial agents) or fungi (antifungal agents). Antibiotics, which may be grouped into several classes, are used both in humans and animals to treat various bacterial infections and to prevent such infections.

30 Certain antibiotics, including virginiamycin, are also used as additives in feedingstuffs as growth promoters for animals. They are added in very low concentrations to the feedingstuffs of growing poultry, pigs and calves. This results in improved growth and improved weight gain, so that an animal needs less time and less food to attain its required weight for slaughter. The practice is also said to have beneficial side effects, in particular the prevention of diseases in animals and reduced production of waste in livestock-farming.

31 Certain bacteria are naturally resistant to certain antibiotics. Nevertheless, in humans and in animals bacteria which are, as a general rule, sensitive to certain antibiotics may develop the capacity to resist those antibiotics. The development of resistance of that kind enables a bacterium to live in the presence of an antibiotic which would, in normal circumstances, kill it or prevent its reproduction. Where a bacterium has developed resistance to an antibiotic, treatment of the patient concerned with that antibiotic becomes totally or partly ineffective. In addition, a bacterium resistant to one member of a class of antibiotics may also become resistant to other antibiotics of the same class. This process is called `cross-resistance'.

32 The phenomenon of resistance to antibiotics in humans was discovered shortly after the first antibiotics were developed. However, generally speaking, resistance to antibiotics in humans has increased in recent years. At the same time, although the pharmaceutical industry continues to research and develop new products, there has been a relative decline in the development and marketing of effective new antimicrobial chemotherapeutic agents designed to combat certain pathogens.

33 The recommendations made in the report on a European-Union conference held in Copenhagen in September 1998 on the subject of the microbial threat (`the Copenhagen Recommendations') state that `resistance to antimicrobial agents is a major public health problem in Europe'. Antibiotic resistance in humans can result in a substantial rise in the number of complications in the treatment of certain diseases and even an increased mortality risk arising from those diseases.

34 The reasons for the development of resistance to antibiotics in humans have not yet been entirely clarified. It appears from the documents before the Court that there is a broad consensus among experts that this phenomenon is primarily caused by the excessive and inappropriate use of antibiotics in human medicine.

35 Nevertheless, the existence of a link between the use of antibiotics as growth promoters in animals and the development of resistance to those products in humans is, to a large extent, recognised by the scientific community. It is presumed that the antibiotic resistance which has developed in animals can be transferred to humans.

36 The possibility and the probability of such transfer and the risk which it may entail for public health continue to give rise to argument in scientific circles (see the parties' submissions on this point, particularly in connection with the plea concerning breach of the precautionary principle). However, on the basis of the available results of research, numerous international, Community and national bodies adopted various recommendations on the subject over the years preceding the adoption of Council Regulation (EC) No 2821/98 of 17 December 1998 amending, as regards withdrawal of the authorisation of certain antibiotics, Directive 70/524 (OJ 1998 L 351, p. 4; `the contested regulation'). (See in that regard the report of a World Health Organisation Meeting (`WHO') in Berlin in October 1997, `The Medical Impact of the Use of Antimicrobials in Food Animals', (`the WHO report'); the Resolution of the European Parliament of 15 May 1998 on the use of antibiotics in feedingstuffs (OJ 1998 C 167, p. 306); the Opinion of the Economic and Social Committee of 9 September 1998 on the subject: `Resistance to antibiotics: a threat to public health' (OJ 1998 C 407, p. 7); the Copenhagen Recommendations; the House of Lords Science and Technology Committee (United Kingdom), Seventh Report, March 1998, `the House of Lords report'; the document from the Centre for Science in the Public Interest (Washington D.C., United States of America) entitled `Protecting the Crown Jewels of Medicine', May 1998; the document from the United Kingdom Ministry of Agriculture, Fisheries and Food, `A Review of Antimicrobial Resistance on the Food Chain', July 1998, `the United Kingdom report'; the document from the Health Council of the Netherlands, `Antimicrobial Growth Promoters', August 1998, `the Netherlands report'.)

37 In particular, the abovementioned bodies have almost unanimously recommended increasing research efforts in this field. For example, in 1997 the Commission, jointly with the Member States and the pharmaceutical industry, set up a research programme (`Surveillance Programme'), the first results of which were to be published in 2000. In addition, some of those bodies recommend the systematic replacement of all antibiotics used as growth promoters by safer alternatives. Furthermore, several bodies, including the WHO, have recommended the immediate or gradual discontinuance of the use of antibiotics as growth promoters in animals. Some of the abovementioned reports suggest prohibiting the practice, first, where the antibiotics concerned are used in human medicine or their use in humans is envisaged and, second, where they are known to `select' cross-resistance to antibiotics used as medicinal products for humans.

38 Virginiamycin is an antibiotic belonging to the streptogramin class. It has been used exclusively as a growth promoter for animals for more than 30 years. A certain level of resistance to virginiamycin has been observed in animals which have been treated with that product.

39 Other antibiotics belonging to the same class are used in human medicine, namely pristinamycin, used for 30 years in certain Member States, particularly France, and Synercid, which is a mixture of the antibiotics dalfopristin and quinupristin and has recently been developed and authorised in the United States but which, at the date of adoption of the contested regulation, had not yet been authorised in the Community.

40 Although at present dalfropristin and quinupristin are relatively little used in human medicine, they could play an important part in the Community in the treatment of infections caused in patients by bacteria which have developed resistance to other antibiotics, namely the bacteria Enterococcus faecium (`E. faecium') and Staphylococcus aureus. These bacteria may cause dangerous infections, particularly in hospital patients who already have a deficient immune system. Hitherto patients infected by these bacteria have been treated with an antibiotic belonging to another class, vancomycin. However, it has been found that these bacteria are becoming increasingly resistant to vancomycin. Experts refer to `vancomycin-resistant E. faecium' (VRE) and `methicillin-resistant Staphylococcus aureus' (MRSA), which has also become resistant to vancomycin (`vancomycin-resistant MRSA'). In those circumstances, the administration of streptogramins, particularly Synercid, could be the treatment of last resort against infections caused by those bacteria, at least until other antibiotics capable of combating those infections have been developed and placed on the market. However, the effectiveness of such treatment could be reduced or even eliminated by any transfer of resistance to virginiamycin from animals to humans and by the development of cross-resistance in humans to the other members of the streptogramin class.

41 It is common ground between the parties and is apparent from the preamble to the contested regulation that, at the time when the measure was adopted, the transfer and development of such resistance had not yet been scientifically established in respect of streptogramins.

II - The procedure leading to the adoption of the contested regulation

42 When the contested regulation was adopted, Pfizer Animal Health SA (`Pfizer') was the only producer in the world of virginiamycin, which was made in its factory in Rixensart, Belgium. The product was marketed under the trade name `Stafac'.

43 Virginiamycin was authorised as an additive in feedingstuffs for certain poultry and pigs when Directive 70/524 entered into force and was included in Annex I to that Directive. That authorisation was subsequently extended to other animals. In certain cases the authorisation was without limitation as to time, while in others it was for a specific period. After Directive 96/51 entered into force, and for the purpose of granting a further authorisation under the new rules, the various authorisations of virginiamycin were transferred to Chapter I, II or III of Annex B to Directive 70/524 in accordance with Articles 9g, 9h and 9i of that directive.

44 In reliance on the safeguard clause provided for in Article 11 of Directive 70/524, the Kingdom of Denmark, by letters of 13 January 1998, informed the Commission and the competent authorities of the Member States of the European Economic Area (`EEA') of its decision to ban the use in its territory of virginiamycin in feedingstuffs with effect from 16 January 1998. In doing so, it relied on a report from the National Veterinary Laboratory dated 7 January 1998 (`the Status Report'), which contains the following conclusions:

`It is strongly indicated that the use of virginiamycin as a growth promoter for pigs and broilers selects for virginiamycin-resistant E. faecium (selection). Virginiamycin-resistant E. faecium are simultaneously resistant to other streptogramins, such as pristinamycin and Synercid, potentially useful for treatment of human enterococcal infections (cross-resistance). In some of the virginiamycin-resistant E. faecium from animals, the sat A gene which confers streptogramin resistance was detected. This gene has also been found to occur in streptogramin-resistant E. faecium causing infection in human hospital patients in France. It is very probable that virginiamycin-resistant E. faecium can be transmitted from animals to human beings, and furthermore, it cannot be excluded that the sat A gene may be transferred from E. faecium animals to E. faecium in humans.

At present streptogramins are not in use for treatment of human infections in Denmark. Therefore an acute threat to public health does not exist. However, it cannot be ruled out that streptogramins will be used for treating human infections in the future. If that happens, the use of virginiamycin as a growth promoter will increase that risk of adverse resistance development.'

45 On 22 January 1998 the Kingdom of Belgium, the Member State acting as rapporteur for the purposes of Article 4 of Directive 70/524 on the dossier concerning virginiamycin, forwarded the Status Report to Pfizer and requested it to submit its observations.

46 On 2 February 1998 the Kingdom of Sweden, with a view to a decision being taken by 31 December 1998 and in accordance with Annex XV to the Act of Accession (see paragraph 2 above), submitted a request for the adaptation of Directive 70/524, together with a detailed scientific statement of reasons, seeking withdrawal of the authorisation, inter alia, of antibiotics used as growth promoters, including virginiamycin (`the Swedish report').

47 On 25 February 1998 the Kingdom of Denmark wrote to the Commission and the other Member States to notify them that at a later date it would send them a supplementary scientific report setting out its reasons for applying the safeguard clause in relation to virginiamycin.

48 On 12 and 13 March 1998 the Danish authorities sent the Commission and the Member States of the EEA two new scientific publications concerning the transfer of antimicrobial resistance from animals to humans.

49 On 16 and 23 March 1998 discussions took place between Pfizer and Commission officers dealing with the matter.

50 On 31 March 1998 Pfizer submitted its observations on the Status Report, together with scientific reports and literature, to the Commission, the Member States and the members of SCAN. In its observations Pfizer submits that examination of the reports and scientific literature annexed to them shows that scientific knowledge relating to the possible transfer of resistance to virginiamycin from animals to human beings is either totally absent or inadequate. It concludes:

`The issue of antibiotic resistance is without question an important public health issue. It is also clear that the current body of scientific data - including the Danish studies - do not provide the scientific evidence necessary to conduct a detailed evaluation of any potential risk associated with the use of virginiamycin as a feed additive antibiotic. Aside from the methodological weakness or preliminary nature of the studies cited in the Status Report, new and relevant streptogramin susceptibility surveillance data from human clinical isolates stand in direct contradistinction to the risks hypothesised.'

51 On 1 April 1998 the Kingdom of Denmark sent the Commission and SCAN the supplementary report of the National Veterinary Laboratory, as it had said it would in the letter of 25 February 1998 (`the supplementary report from the Danish Veterinary Laboratory'). The report sets out the results of scientific research by the National Veterinary Laboratory, which are based on 10 conclusions and led the Danish authorities to adopt the safeguard measure.

52 On 13 May 1998 Pfizer submitted its observations on the Supplementary Report from the Danish Veterinary Laboratory to the Commission, the EEA Member States and the members of SCAN.

53 On 10 July 1998 SCAN published, at the Commission's request, a scientific opinion on the immediate and longer-term risk to the value of streptogramins in human medicine posed by the use of virginiamycin as an animal growth promoter (`the SCAN opinion'). In that opinion, SCAN analysed the conclusions in the Supplementary Report from the Danish Veterinary Laboratory and added a comment in respect of each of those conclusions. Lastly, SCAN drew the following general conclusions:

`I. Having considered the evidence provided by the Danish Government in support of their action taken under the safeguard clause against virginiamycin, the SCAN concludes that:

1. No new evidence has been provided to substantiate the transfer of a streptogramin or vancomycin resistance from organisms of animal origin to those resident in the human digestive tract and so compromise the future use of therapeutics in human medicine.

2. The development of vancomycin resistance amongst E. faecium and methicillin-resistant strains of Staphylococcus aureus, which the SCAN recognises are increasingly responsible for nosocomial infections worldwide, are evidently a cause for concern. However, the data provided in the supplementary report from the Danish Veterinary Laboratory do not justify the immediate action taken by Denmark to preserve streptogramins as therapeutic agents of last resort in humans.

3. As survey data provided under the aegis of DANMAP and included in the supplementary report from the Danish Veterinary Laboratory failed to detect a single case of VRE, as Denmark has amongst the lowest incidence of MRSA in Europe and North America, and as coagulase-negative staphylococci remain sensitive to vancomycin, there are no clinical reasons to require the introduction of streptogramins as human therapeutics in Denmark now or in the immediate future. Furthermore, as the Commission has elected to take the precautionary action of removing avoparcin from the antibiotics permitted for use as growth promoters to help preserve the efficacy of vancomycin in human therapy, any future need for streptogramins might be delayed further in Denmark.

For these reasons the SCAN concludes that the use of virginiamycin as a growth promoter does not constitute an immediate risk to public health in Denmark.

II. The SCAN is sympathetic to the general concern highlighted by the Danish action about the hazard that a reservoir of resistance genes within the animal population poses for humans. However, it is of the opinion that a full risk assessment cannot be made until quantitative evidence of the extent of transfer of antimicrobial resistance from livestock sources is obtained and the significance of this within the overall use of antimicrobials for clinical and non-clinical purposes evaluated. The SCAN is also of the opinion that this is best approached by considering the totality of antimicrobial use within the countries of the European Union rather than on a case by case basis. The Scientific Steering Committee has established a multidisciplinary working group with this remit.

The SCAN also notes that in countries that permit the use of streptogramins in both animal production and human medicine, notably France and the USA, the use of pristinamycin has not been compromised by the use of virginiamycin as growth promoter.

The SCAN is therefore firmly of the opinion that any risk that might be posed in the future by the use of virginiamycin as a growth promoter will not materialise in the time required to make such an evaluation and most probably not for some years afterwards. In the meantime monitoring initiated by the Danish Government and the EU will be able to detect any significant increases in glycopeptide and streptogramin resistance in enterococci and staphylococci should that occur.'

54 At the Standing Committee meeting of 16 and 17 July 1998, the Danish member of the Committee informed the other members that a new scientific study of live laboratory rats, carried out in Denmark after the adoption of the safeguard measure (B. Jacobsen and others, `In vivo Transfer of the Sat A gene between isogenic strains of Enterococcus faecium in the Mammalian Gastrointestinal Tract': `the new study on live rats') provided new relevant evidence that resistance to streptogramins could be transferred from animals to humans under normal conditions. A copy of it was distributed informally to all members of the Standing Committee. At the request of the Commission, on 27 August 1998 Denmark sent the study to Pfizer, the Commission and the EEA Member States.

55 On 15 September 1998 Pfizer, pursuant to Articles 9g(2) and 9h(2) of Directive 70/524, lodged new applications for the authorisation of virginiamycin as an additive linked to a person responsible for putting it into circulation.

56 On 5 October 1998 the Kingdom of Denmark sent Pfizer, the Commission, the EEA Member States and the members of SCAN its observations on the SCAN Opinion. Denmark requested the Commission and SCAN to re-examine the question posed in the light of the new study on live rats.

57 At the plenary session of 5 November 1998, SCAN made the following statement concerning the new study on live rats, which appears in the minutes of the meeting as approved at the meeting of 25 January 1999:

`The Committee considered the document submitted by Denmark on virginiamycin and stated that it does not bring new information on the subject.'

58 On 10 November 1998 a meeting took place between Pfizer and members of the cabinet of Mr Fischler, the Member of the Commission responsible for agriculture.

III - The contested regulation

59 On 17 December 1998 the Council adopted the contested regulation, which was published in the Official Journal of the European Communities on 29 December 1998. The operative part of the contested regulation reads as follows:

`Article 1

The entries in Annex B to Directive 70/524/EEC for the following antibiotics shall be deleted:

...

- virginiamycin,

...

Article 2

The Commission shall re-examine the provisions of this regulation before 31 December 2000 on the basis of the results given by:

- the different investigations concerning the induction of resistances by the use of the antibiotics concerned, and

- the surveillance programme of microbial resistance in animals which have received antibiotics, to be carried out in particular by the persons responsible for putting the additives concerned into circulation.

Article 3

This Regulation shall enter into force on the day of its publication in the Official Journal of the European Communities.

It shall apply from 1 January 1999.

However, where, on the date on which this Regulation enters into force, a Member State has not banned, in accordance with Community law, one or more of the antibiotics referred to in Article 1 of this Regulation, such antibiotic or antibiotics shall remain authorised in that Member State until 30 June 1999.

...'.

Procedure

60 By application lodged at the Registry of the Court of First Instance on 18 January 1999, Pfizer brought the present action.

61 By separate document lodged at the Court Registry on 10 March 1999, the Council raised an objection of inadmissibility pursuant to Article 114(1) of the Rules of Procedure. By order of 7 March 2000, the Court (Third Chamber) reserved its decision on the objection of inadmissibility for the final judgment pursuant to Article 114(4) of the Rules of Procedure. In addition, by way of measures of organisation of procedure, the Court, on 13 March 2000, sent a number of written questions to the parties, who replied within the period allowed.

62 By separate document lodged at the Court Registry on 15 February 1999, Pfizer also applied, pursuant to Articles 185 and 186 of the EC Treaty (now Articles 242 EC and 243 EC), first, for suspension, either wholly or in part, of operation of the contested regulation pending judgment in the main action or until a date to be fixed, and, second, for the adoption of such other measures as justice might require. By order of 30 June 1999 in Case T-13/99 R Pfizer Animal Health v Council [1999] ECR II-1961, the President of the Court of First Instance dismissed the application for interim relief. Pfizer appealed against that order and its appeal was dismissed by order of the President of the Court of Justice of 18 November 1999 (Case C-329/99 P(R) Pfizer Animal Health v Council [1999] ECR I-8343).

63 Upon application by them, the President of the Third Chamber, by order of 25 June 1999, granted the following parties leave to intervene in support of Pfizer: Asociación nacional de productores de ganado porcino (`Anprogapor'), Asociación española de criadores de vacuno de carne (`Asovac'), Fédération européenne de la santé animale (`Fedesa'), Fédération européenne des fabricants d'adjuvants pour la nutrition animale (`Fefana'), and Mr Kerckhove and Mr Lambert. By the same order, the President dismissed the applications to intervene submitted by the Asociación española de productores de huevos and The Pig Veterinary Society. As a result of the withdrawal of Mr Kerckhove and Mr Lambert as interveners, the President of the Third Chamber removed their names from the list of interveners by order of 26 September 2000.

64 The interveners supporting Pfizer lodged their written observations, initially limited to the admissibility of the action, on 6 September 1999 (Anprogapor and Asovac) and 7 September 1999 (Fedesa and Fefana), and subsequently on the substance of the case, on 30 June 2000 (Anprogapor and Asovac) and 13 July 2000 (Fedesa and Fefana).

65 Also upon application by them, the President of the Third Chamber, by orders of 25 March, 19 May and 6 September 1999, granted the Commission, the Kingdom of Denmark, the Kingdom of Sweden, the Republic of Finland and the United Kingdom of Great Britain and Northern Ireland leave to intervene in support of the form of order sought by the Council. The interveners lodged their written observations, initially limited to the admissibility of the action, on 31 May 1999 (the Commission) and 11 August 1999 (the Kingdom of Denmark). By letter of 25 October 1999, the United Kingdom of Great Britain and Northern Ireland stated that it did not intend to lodge observations as to admissibility. The Republic of Finland and the Kingdom of Sweden did not lodge observations on admissibility. Subsequently, the interveners lodged written observations on the substance of the case, on 30 June 2000 (the Republic of Finland and the Kingdom of Sweden), 17 July 2000 (the United Kingdom of Great Britain and Northern Ireland) and 25 July 2000 (the Commission).

66 By separate document of 30 July 2000, Pfizer requested, first, that the case be given priority under Article 55(2) of the Rules of Procedure and, second, that a number of measures of organisation of procedure be adopted pursuant to Article 64 of the Rules of Procedure. The Council lodged written observations on these requests on 9 September 1999. The interveners lodged their observations on 6 September 1999 (Fedesa and Fefana), 7 September 1999 (the Commission), 9 September 1999 (the Republic and Finland and the Kingdom of Sweden) and 13 September 1999 (Anprogapor and Asovac).

67 The written procedure was closed by the lodging of the rejoinder on 12 October 2000. Upon hearing the report of the Judge Rapporteur, the Court (Third Chamber) decided to open the oral procedure. By way of measures of organisation of procedure, on 18 December 2000 and 20 June 2001, the Court called on the parties to reply to certain questions and to produce certain documents. The parties complied with those requests. Furthermore, the Court had regard, as far as possible given the volume of the pleadings and of the documentation produced, to the request that the case be given priority.

68 The parties were heard in oral argument and answered questions put to them by the Court at the hearing on 2 July 2001. At the hearing the Court asked the Council and the Commission to produce documents. Once they had complied with that request, Pfizer was requested to submit its observations on those documents. On 3 September 2001, the President of the Third Chamber of the Court of First Instance closed the oral procedure.

Forms of order sought

69 Pfizer claims that the Court should:

- annul the contested regulation in its entirety or as regards virginiamycin;

- take such other measures as it deems appropriate;

- order the Council to pay the costs.

70 The Council contends that the Court should:

- dismiss the action as manifestly inadmissible;

- in the alternative, dismiss the action as unfounded;

- order Pfizer to pay the costs.

71 Anprogapor, Asovac, Fedesa and Fefana intervene in support of the form of order sought by Pfizer.

72 The Commission, the Kingdom of Denmark, the Kingdom of Sweden, the Republic of Finland and the United Kingdom of Great Britain and Northern Ireland intervene in support of the form of order sought by the Council.

Admissibility

I - Arguments of the parties

73 The Council begins by observing that Pfizer, which seeks annulment of the contested regulation in its entirety, has adduced no arguments whatsoever with regard to additives which are not produced and marketed by it. Its action is in any event manifestly exorbitant in that respect.

74 In addition, according to the Council, the contested regulation is an act of general application which applies to objectively determined situations and produces legal effects on categories of persons viewed abstractly and in their entirety.

75 In the alternative, the Council contends that the contested regulation is not of individual concern to Pfizer for the purposes of the fourth paragraph of Article 173 of the EC Treaty (now, after amendment, the fourth paragraph of Article 230 EC). With regard to virginiamycin in particular, there is nothing to distinguish Pfizer from all other producers or potential producers of that product in the Community or in other parts of the world, who are subject to the same restrictions and are hence affected by the contested regulation in the same way. Furthermore, the Council considers that the ban on the use of the additive in question also affects farmers, who will no longer enjoy the economic benefits deriving from its use, as well as producers and distributors of feedingstuffs.

76 Nor can the action be considered admissible on account of the contacts which Pfizer had with the Commission prior to the adoption of the contested regulation, since the provisions of Directive 70/524 governing the withdrawal of authorisation of additives do not confer any procedural guarantee on the traders concerned.

77 Pfizer's situation in this case also differs from that of the applicant in Case C-309/89 Codorniu v Council [1994] ECR I-1853. The contested regulation does not concern the use of intellectual property rights, as was the case in Codorniu. It merely bans a particular use of the substances in question, whether they are marketed by Pfizer or by anyone else under a different name. Therefore Pfizer is not in a situation comparable to that of an undertaking such as Codorniu, which exploited a trade mark for sparkling wines, but rather in a situation comparable to that of champagne producers.

78 The Commission adds that, as regards the nature of the contested regulation, it is purely by chance that there was only one producer of virginiamycin in the world. That fact was in no way relevant to the adoption of the regulation. The fact that Pfizer was the only manufacturer of virginiamycin in the world did not mean that it had a manufacturing monopoly and there was nothing to prevent another undertaking from manufacturing the substance concerned.

79 The Kingdom of Denmark observes in particular that a case such as this should be dealt with exclusively by the national courts, which may make a reference to the Court of Justice for a preliminary ruling. It adds that there was nothing to prevent Pfizer from bringing an action before a national court and that it had in fact done so. Furthermore, with regard to the requirement that the applicant be individually concerned by the contested regulation, the Kingdom of Denmark observes that neither the product name, `Stafac', nor Pfizer's name appears in the contested regulation. The Kingdom of Denmark adds that, were virginiamycin to be authorised again in the Community, there would be no legal obstacle to prevent other producers from obtaining authorisation to market it, provided that they applied for such authorisation. Consequently Pfizer has never had, and could never obtain, the exclusive right to produce and market virginiamycin.

80 Pfizer and the interveners supporting it maintain that the contested regulation is in the nature of a decision addressed to Pfizer. In any event, Pfizer is directly and individually concerned by the measure.

II - Findings of the Court

81 The fourth paragraph of Article 173 of the Treaty gives individuals the right to challenge inter alia any decision which, albeit in the form of a regulation, is of direct and individual concern to them. The particular objective of that provision is to prevent the Community institutions from being able, merely by choosing the form of a regulation, to preclude an individual from bringing an action against a decision which concerns him directly and individually and thus to make it clear that the nature of a measure cannot be changed by the form chosen (see, inter alia, Joined Cases 789/79 and 790/79 Calpak and Società Emiliana Lavorazione Frutta v Commission [1980] ECR 1949, paragraph 7, and Case T-298/94 Roquette Frères v Council [1996] ECR II-1531, paragraph 35).

82 The criterion distinguishing a regulation from a decision must be sought in the general application, or otherwise, of the measure in question (see, in particular, the order in Case C-168/93 Gibraltar and Gibraltar Development v Council [1993] ECR I-4009, paragraph 11, and the order in Case T-107/94 Kik v Council and Commission [1995] ECR II-1717, paragraph 35). A measure is of general application if it applies to objectively determined situations and produces its legal effects with respect to categories of persons viewed generally and in the abstract (see, for example, Case 307/81 Alusuisse v Council and Commission [1982] ECR 3463, paragraph 9, and the order in Kik v Council and Commission, cited above, paragraph 35).

83 In this instance the contested regulation provides for withdrawal of the authorisation to market certain additives in feedingstuffs, including virginiamycin, in the Community. That measure applies not only to all the existing or potential manufacturers of that product but also to other traders, such as livestock farmers and producers and distributors of feedingstuffs. It thus applies to objectively determined situations and has legal effects with respect to categories of persons viewed generally and in the abstract. It is therefore general in nature.

84 However, the fact that the contested regulation is of general application does not preclude it from being of direct and individual concern to certain natural and legal persons (see, to that effect, Codorniu v Council, cited at paragraph 77 above, paragraph 19, and the order in Case T-11/99 Van Parys and Others v Commission [1999] ECR II-2653, paragraph 40). In those circumstances, a Community measure can be of a general nature and, at the same time, vis-à-vis some of the traders concerned, in the nature of a decision (Joined Cases T-481/93 and T-484/93 Exporteurs in Levende Varkens and Others v Commission [1995] ECR II-2941, paragraph 50, and the order in Van Parys and Others v Commission, paragraph 40).

85 In so far as the contested regulation concerns additives other than virginiamycin which are not manufactured by Pfizer, the Court finds that it does not have any effect on Pfizer's legal situation. Consequently, the application must be dismissed as inadmissible to the extent to which it seeks annulment of the contested regulation in so far as it concerns additives other than virginiamycin.

86 As regards the requirement that the contested regulation should be of direct concern in so far as it concerns virginiamycin, it is appropriate to observe that, in order to meet that requirement, the measure at issue must directly affect the legal situation of the individual and leave no discretion to the addressees of that measure who are entrusted with the task of implementing it, such implementation being purely automatic and resulting from Community rules without the application of other intermediate rules (see, in particular, Case C-354/87 Weddel v Commission [1990] ECR I-3847, paragraph 19; Case C-404/96 P Glencore Grain v Commission [1998] ECR I-2435, paragraph 41; and Case C-386/96 P Dreyfus v Commission [1998] ECR I-2309, paragraph 43).

87 As the Council recognises, Pfizer is directly concerned by the contested regulation in so far as it withdraws the authorisation of virginiamycin as an additive in feedingstuffs. The effect of the measure, which applies directly to all the traders concerned without any need for intermediate rules to be adopted, is to remove Pfizer's authorisation to market that substance.

88 As to whether Pfizer is individually concerned by the contested regulation in so far as it concerns virginiamycin, the Court observes that natural or legal persons may claim that a measure of general application is of individual concern to them only if they are affected by reason of certain attributes which are peculiar to them or by reason of circumstances in which they are differentiated from all other persons (Case 25/62 Plaumann v Commission [1963] ECR 95, at 107; Codorniu v Council, cited at paragraph 77 above, paragraph 20; and Case T-12/93 CCE de Vittel and Others v Commission [1995] ECR II-1247, paragraph 36).

89 Contrary to Pfizer's submission, the fact that at the time when the contested regulation was adopted Pfizer was the only manufacturer of virginiamycin in the world and the only undertaking to market that substance in the Community is not, in itself, such as to distinguish Pfizer from all the other traders concerned. It must be borne in mind that the fact that it is possible to determine the number or even the identity of the persons to whom a measure applies at a given moment with a greater or lesser degree of precision does not mean that those persons must be considered to be individually concerned by it, as long as it is established that the measure is applied by virtue of an objective legal or factual situation defined by it (Case C-213/91 Abertal and Others v Council [1993] ECR I-3177, paragraph 17; and the order of 30 September 1997 in Case T-122/96 Federolio v Commission [1997] ECR II-1559, paragraph 55).

90 However, it is appropriate to analyse the provisions under which the contested regulation was adopted in so far as the latter concerns virginiamycin in order to ascertain whether Pfizer was affected by the adoption of the measure by reason of certain attributes which are peculiar to it or by reason of circumstances in which it is differentiated from all other persons.

91 Although the withdrawal of the authorisation of virginiamycin was adopted under Articles 11 and 24 of Directive 70/524, it is nevertheless appropriate to take into account that the authorisation was withdrawn in the course of the procedure for re-evaluating the authorisation of that substance prescribed by the transitional rules laid down by Articles 9g, 9h and 9i of Directive 70/524, which were inserted by Directive 96/51 (see paragraphs 20 to 23 above).

92 Virginiamycin was authorised as an additive in feedingstuffs under the relevant provisions of the original rules, namely under Directive 70/524 prior to the entry into force of Directive 96/51. Under the original rules authorisation to market those substances as additives was not linked to specific manufacturers. Article 13 of Directive 70/524, as amended by Directive 84/587, merely provided, as regards manufacturers, that antibiotics could be put on the market as additives in feedingstuffs only if they had been produced by manufacturers found by at least one Member State to have fulfilled certain minimum conditions and whose names had been published by the Member State concerned and forwarded to the other Member States and to the Commission. Consequently, although, as Pfizer has pointed out, competitors had material difficulties in producing and marketing virginiamycin, from a legal standpoint any natural or legal person who met the abovementioned criteria could market it.

93 One of the major changes that Directive 96/51 made to the original rules was to link the authorisation of additives such as antibiotics to the person or, where appropriate, the persons responsible for putting the product into circulation, who are the only persons authorised to put the additives in question into circulation. The `person responsible for putting [an additive] into circulation' was defined in Article 2(1) of Directive 70/524, as amended by Directive 96/51, as the natural or legal person who has responsibility for the conformity of the additive which has been granted Community authorisation and for putting it into circulation. Under the new rules, authorisations to market antibiotics as additives in feedingstuffs are thus granted by way of a Commission or Council regulation, in accordance with the procedure referred to in Article 4 of Directive 70/524, as amended by Directive 96/51, to specific producers whose names are published each year in the Official Journal in accordance with Article 9t of the Directive.

94 As is apparent from recital 2 of the preamble to Directive 96/51, the link between the authorisation of an additive, such as an antibiotic, and a specific producer was introduced in order to prevent poor copies of additives from being put into circulation in the Community.

95 It is true that, as the Council and the interveners supporting it have pointed out, at the time when the contested regulation was adopted, Pfizer had not acquired the status of person responsible for putting virginiamycin into circulation. At that time, the re-evaluation procedure prescribed by the transitional rules had not yet been completed.

96 However, under Articles 9g, 9h and 9i of Directive 70/524, as amended by Directive 96/51, which lay down the procedures for re-evaluation and new authorisation of the additives concerned, only the person or persons responsible for the dossier on the basis of which the former authorisation was granted, or their successor or successors, were in a position to make a new application, before 1 October 1998, for authorisation of the additive concerned; similarly, following that application, only that person or those persons could, on the basis of those provisions and by means of a regulation to be adopted no later than 1 October 2003, obtain a new authorisation as the person responsible for first putting the product concerned into circulation, for a period of 10 years or 5 years as appropriate.

97 In the present case Pfizer, the only producer of virginiamycin in the world, made applications on 15 September 1998 under Articles 9g and 9h for re-evaluation of that substance as an additive in the feedingstuffs of certain animals. Consequently, under those provisions, Pfizer was the only person who, at the time when the contested regulation was adopted, was in a legal position which would have enabled it to obtain, under those particular procedural provisions and through a Commission or Council regulation, authorisation to market virginiamycin as the person first responsible for putting it into circulation and thereby to be entered on the list provided for in Article 9t of Directive 70/524. Furthermore, if, following re-examination of the withdrawal of the authorisation of virginiamycin, as provided for in Article 2 of the contested regulation, that product had been authorised again, only Pfizer, following the re-opening of the re-evaluation procedure, would have been in a position to obtain a new authorisation of virginiamycin as an additive linked to a person responsible for putting it into circulation. Consequently, although, at the time when the contested regulation was adopted, it had not acquired the status of person first responsible for putting virginiamycin into circulation, since the re-evaluation procedure laid down by Directive 96/51 was still continuing, Pfizer was already able to rely on an inchoate right in that regard.

98 Although it is also true that the status of person first responsible for putting an additive into circulation for the purposes of Articles 9g, 9h and 9i does not confer on that person an exclusive right to market the additive, it is none the less the case that, by virtue of having made an application for a further authorisation, Pfizer had obtained a position in respect of which Directive 70/524 offered legal safeguards. In particular, under Article 9c(1) of Directive 70/524, `the scientific data and other information in the initial dossier submitted for the purpose of the first authorisation may not be used for the benefit of other applicants for a period of 10 years' from the date of the first authorisation by means of regulation. The reason for that provision is stated in recital 14 of the preamble to Directive 96/51 to be the fact that `the search for new additives belonging to the group of substances for which authorisation is linked to those persons responsible for putting them into circulation requires costly investment'. In the particular circumstances of the present case, certain elements of that provision closely resemble a specific right comparable to the right on which the applicant undertaking could rely in Codorniu v Council (cited at paragraph 77 above).

99 Therefore, under the broad scheme of Directive 70/524, as amended by Directive 96/51, manufacturers who, like Pfizer, submit a new application for authorisation under Articles 9g, 9h and 9i of the Directive enjoy a particular legal situation. In accordance with those provisions, manufacturers such as Pfizer have taken all the steps necessary to acquire the status of person first responsible for putting the additive concerned into circulation, to take responsibility in the future for ensuring that the product complies with its Community authorisation and to gain protection for the scientific data and other information provided by them in the dossier submitted with a view to obtaining for their product the first authorisation as an additive linked to a person responsible for putting it into circulation.

100 Consequently, even before the end of the transitional period, Pfizer was affected by withdrawal of the authorisation of virginiamycin following on the adoption of the contested regulation by reason of certain attributes which were peculiar to it and which differentiated it from all other persons.

101 As to Pfizer's participation in the procedure culminating in the adoption of the contested regulation, the Court observes that the regulation was adopted under the procedure laid down in Article 24 of Directive 70/524 and that that provision does not entitle the traders concerned to take part in the procedure (see paragraph 19 above). In that context, the Council rightly points out that, in accordance with settled case-law, the fact that a person is involved in some way or other in the procedure leading to the adoption of a Community measure is capable of distinguishing that person individually in relation to the measure in question only if the applicable Community legislation grants him certain procedural guarantees (see, to that effect, paragraph 55 of the judgment in Exporteurs in Levende Varkens and Others v Commission, cited at paragraph 84 above; and the order in Case T-585/93 Greenpeace and Others v Commission [1995] ECR II-2205, paragraphs 56 and 63).

102 Account must nevertheless be taken of the fact that, by making new applications for authorisation of virginiamycin in accordance with paragraphs (2) and (4) of Article 9g of Directive 70/524, as amended by Directive 96/51, Pfizer was in a position to be able to submit, in accordance with the procedure laid down in Article 4 of that directive and no later than 30 September 2000, a scientific dossier with a view to re-evaluation of the additive concerned. However, the procedure laid down in Article 4 is not only instigated on the application of the operator concerned but also confers on that person procedural guarantees. The operator concerned must be notified, throughout the various stages of that procedure, if the application does not comply with the relevant provisions, if it is rejected or even if processing of it is merely postponed.

103 Although it is true, as the Council has pointed out, that the procedure in Article 24 of Directive 70/524, as applied in this instance, is different from the procedure under Articles 9g and 4 thereof, it is nevertheless the case that adoption of the contested regulation terminated or, at the least, suspended the procedure under Articles 9g and 4, which had been instigated by Pfizer's application for a new authorisation. That fact is borne out by a letter of 8 November 1999, in which the competent officials at the Commission indicated to Pfizer, following its specific question, that `as a consequence of the [contested] regulation, virginiamycin is not subject any more to Articles 9g, 9h and 9i ... Thus, although Pfizer has submitted before 1 October 1998 identification notes and monographs in accordance with Article 9g, 9h and 9i(2), the above articles do not apply any longer to virginiamycin. As long as virginiamycin is not covered by the said provisions, it is not possible to submit or evaluate a dossier under the procedure they provide for.'

104 In such a context, by terminating or, at the least, suspending the procedure which had been opened, at Pfizer's request, for the purposes of obtaining a new authorisation of virginiamycin as an additive in feedingstuffs, and in the course of which Pfizer had the benefit of procedural guarantees, the contested regulation affects Pfizer by reason of a legal and factual situation which differentiates it from all other persons. That fact is also such as to distinguish Pfizer for the purposes of the fourth paragraph of Article 173 of the Treaty.

105 It follows that, so far as Pfizer is concerned, a series of factors exists, constituting a particular situation which differentiates Pfizer, as regards the measure in question, from all other traders concerned by the regulation. Pfizer must therefore be regarded as individually concerned by the contested regulation in so far as it concerns withdrawal of the authorisation of virginiamycin.

106 Therefore the application is admissible to the extent to which it seeks annulment of the contested regulation in so far as the latter withdraws the authorisation of virginiamycin as an additive in feedingstuffs.

Substance

107 Pfizer puts forward eight pleas in law alleging infringement of Article 11 of Directive 70/524 (first plea), manifest errors of assessment (second plea), breach of the precautionary principle (third plea), breach of the principle of proportionality (fourth plea), breach of the principle of legitimate expectations (fifth plea), breach of the obligation to state reasons (sixth plea), infringement of the right to property (seventh plea) and misuse of powers (eighth plea).

108 In the context of the first four pleas and the seventh and eighth pleas, Pfizer submits, in essence, that the contested regulation should be annulled, since the Community institutions have made errors in their analysis, by which is meant the assessment and management, of any risks to human health associated with the use of virginiamycin as a growth promoter, as well as in their application of the precautionary principle. The Court deems it appropriate to examine those pleas together.

I - The pleas alleging errors of risk assessment and management and misapplication of the precautionary principle

109 The preamble to the contested regulation shows that the Council, in adopting the measure, took the view that the use of virginiamycin as an additive in feedingstuffs involved a risk to human health and that accordingly it was necessary to withdraw the authorisations relating to the use of the product.

110 Following some preliminary remarks (A), the Court will start by examining whether, as Pfizer submits, the Council was wrong, on conclusion of a risk assessment that was not properly conducted, to find that the use of virginiamycin as a growth promoter constituted a risk to human health (B). It will then assess whether the Council, in adopting the contested regulation, made errors in its management of the risk (C).

A - Preliminary considerations

111 By the contested regulation, which was adopted on a proposal from the Commission, the Council withdrew Community authorisation from four antibiotics, including virginiamycin, as additives in feedingstuffs. The regulation was adopted on the basis of Directive 70/524, which, in turn, is founded on Article 43 of the EC Treaty (now, after amendment, Article 37 EC). Thus it forms part of the framework of the common agricultural policy.

112 More specifically, as regards virginiamycin, the contested regulation was adopted on the basis of Article 11(3) of Directive 70/524, which inter alia permits the Commission to initiate under Article 24 a procedure amending the lists of authorised antibiotics where it considers such amendments necessary in order to mitigate the difficulties mentioned by a Member State in connection with a safeguard measure and to ensure the protection of human or animal health or the environment. In addition, it is apparent from recital 5 to the contested regulation that the Council took as its basis Article 3a(e) of Directive 70/524, which provides that Community authorisation of an additive in feedingstuffs is to be given only if `for serious reasons concerning human or animal health its use must not be restricted to medical or veterinary purposes'. Finally, as the preamble, in particular recital 21 thereof, to the contested regulation shows, the Council took the view that, so far as virginiamycin was concerned, there was a `serious reason', for the purposes of the abovementioned provision, justifying withdrawal of the authorisation of virginiamycin as an additive in feedingstuffs, namely the risk that the effectiveness of certain human medicinal p