Judgment of the Court of First Instance (Third Chamber) of 11 September 2002. - Alpharma Inc. v Council of the European Union. - Transfer of resistance to antibiotics from animals to humans - Directive 70/524/EEC - Regulation withdrawing authorisation of an additive in feedingstuffs - Admissibility - Breach of essential procedural requirements - 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 - Rights of the defence. - Case T-70/99.



European Court reports 2002 Page II-03495



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 bacitracin zinc, within the Community - Admissibility

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

2. Acts of the institutions - Choice of legal basis - Criteria - Act of Accession

3. Community law - Principles - Legal certainty - Community rules - Requirements of clarity and foreseeability - Express indication of the legal basis - Limit

4. 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))

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

6. Agriculture - Common agricultural policy - Use of bacitracin zinc 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))

7. 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))

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

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

10. 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 committees - Exceptional nature

11. 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))

12. Agriculture - Common agricultural policy - Use of bacitracin zinc as a growth factor in feedingstuffs - Risk for human health - Discretion of the Community institutions - Manifest errors of assessment - None

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

13. Community law - Principles - Proportionality - Acts of the institutions - Proportional character - Criteria for assessment - Discretion of the 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))

14. 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 bacitracin zinc as an additive in feedingstuffs, and in the course of which it had the benefit of procedural guarantees, Regulation No 2821/98 providing for the withdrawal of the authorisation to market certain additives in feedingstuffs, including bacitracin zinc, 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 90-92, 96 )

2. In the context of the organisation of the powers of the Community the choice of a legal basis for a measure must rest on objective factors which are amenable to judicial review. Those factors include in particular the aim and the content of the measure.

A provision of an Act of Accession may serve as the legal basis on which to adopt legislative measures.

( see paras 106-107 )

3. The principle of legal certainty, which is a general principle of Community law, requires Community legislation to be clear and its application foreseeable for all interested parties. As a result of that requirement, the binding nature of any act intended to have legal effects must be derived from a provision of Community law which prescribes the legal form to be taken by that act and which must be expressly indicated therein as its legal basis. However, failure to refer to a precise provision of the Treaty need not necessarily constitute an infringement of essential procedural requirements when the legal basis for the measure may be determined from other parts of the measure. However, explicit reference is indispensable where, in its absence, the parties concerned and the Court are left uncertain as to the precise legal basis.

( see para. 112 )

4. 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. 135 )

5. 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. 140 )

6. 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 bacitracin zinc 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. Rather, 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 for human health and the seriousness of any such adverse effects.

( see paras 152-161 )

7. 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 at 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.

So, 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 164-176 )

8. 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 Community institutions of their discretion in that regard is vitiated by a manifest error or a misuse of powers or whether the Community institutions clearly exceeded the bounds of their discretion.

( see paras 177-180 )

9. 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 181-183 )

10. Even if, under the relevant legislation, the Community institutions are able to withdraw authorisation of an additive in feedingstuffs, without first having obtained an 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 matters.

( see paras 209, 213 )

11. 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 or should have been available to them at the time when the contested measure was adopted.

( see para. 248 )

12. The Community institutions did not make manifest errors of assessment in concluding, on the basis of the factual evidence available at the time of adoption of Regulation No 2821/98 providing for the withdrawal of authorisation to market certain additives in feedingstuffs, including bacitracin zinc, within the Community that the use of that additive as a growth promoter constituted a risk for human health. It is clear, on the contrary, that they could reasonably take the view that there were serious reasons concerning human health, within the meaning of Article 3a(e) of Directive 70/524 concerning additives in feedingstuffs, why bacitracin zinc, as an antibiotic with a dual use as an additive in feedingstuffs and at the same time as a medicinal product for human use, should be confined to medical use.

( see para. 313 )

13. 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 324-325 )

14. 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 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. 388 )

Parties

In Case T-70/99,

Alpharma Inc., established in Fort Lee, New Jersey (United States of America), represented by G. Robert, Solicitor, and B. Van de Walle de Ghelcke, lawyer, with an address for service in Luxembourg,

applicant,

v

Council of the European Union, represented by J. Carbery, M. Sims, J. Monteiro 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

Republic of Finland, represented by H. Rotkirch, T. Pynnä and E. Bygglin, acting as Agents, 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,

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 3 July 2001,

gives the following

Judgment

Grounds

Legislative 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 the first subparagraph of point E1(4) of Title VII of Annex XV to 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. According to the second subparagraph of that provision, 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 25 to 27 and 29 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 Under the original rules, Article 7(1) of Directive 70/524, which was repealed by Directive 96/51, provided that [a]mendments to be made to Annexes on account of the growth of scientific and technical knowledge shall be adopted in accordance with the procedure laid down in Article 23. Furthermore, Article 7(2)(A) of that directive set out the conditions on which additives could be included in Annex I thereto. Article 7(2)(B) stated that [a]n additive shall be deleted from Annex I if any of the conditions listed under A is no longer satisfied.

18 Under the new rules, Article 9m of Directive 70/524, as amended by Directive 96/51, provides that the authorisation of an additive is to be withdrawn by means of a regulation, inter alia, if any of the conditions for the authorisation of the additive referred to in Article 3a are no longer met (second indent). Under the new Article 9r, [a]mendments to be made to the Annexes shall be adopted in accordance with the procedure laid down in Article 23.

19 Article 23 of Directive 70/524, as amended by Directive 84/587 and most recently by Annex I to the Act of Accession, provides:

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

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 on the draft within a time-limit which the chairman may lay down according to the urgency of the matter. 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 three months 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.

20 Furthermore, under Article 11 of Directive 70/524, as amended by Directive 84/587, 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.

3. The transitional rules

21 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.

22 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).

...

23 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.

24 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, SCAN and the Scientific Steering Committee

25 The Standing Committee for Feedingstuffs (the Standing Committee), which is referred to in Article 23 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.

26 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 ... .

27 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.

28 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.

29 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

30 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.

31 Certain antibiotics, including bacitracin zinc, 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.

32 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 by 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.

33 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.

34 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.

35 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.

36 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.

37 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/EEC concerning additives in feedingstuffs (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 ESC Opinion); 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.)

38 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 where, first, 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.

39 Bacitracin zinc is an antibiotic used as a growth promoter for livestock and also in the treatment of certain infections in human medicine.

40 The parties disagree as to whether and to what extent bacitracin zinc does or might play a role in human medicine, in particular for 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). However, the potential effectiveness of treatment of those infections with bacitracin zinc could be reduced or even eliminated by any transfer from animals to humans of resistance to that product.

41 It is common ground between the parties, and is apparent from the recitals 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 bacitracin zinc.

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

42 At the time when the contested regulation was adopted, Alpharma Inc. (Alpharma) was the only manufacturer and the largest supplier of bacitracin zinc in the European Economic Area. It marketed that product, which was manufactured in Norway, under the name Albac.

43 Bacitracin zinc was authorised as an additive in feedingstuffs for certain poultry, calves, lambs and kids, pigs and animals bred for fur when Directive 70/524 entered into force and was included in Annex I to that Directive. That authorisation was subsequently extended to other animals. Bacitracin zinc was also included, as an additive in the feedingstuffs of certain animals, in Annex II to that directive. In particular, a new use for bacitracin zinc for chickens for fattening and pigs was authorised and included in Annex II by Commission Directive 94/41/EC of 18 July 1994 amending Council Directive 70/524 (OJ 1994 L 209, p. 18). By Commission Regulation (EC) No 2786/98 of 22 December 1998 concerning the modification of the period of authorisations of additives referred to in Article 9i(1) of Directive 70/524 (OJ 1998 L 347, p. 25), the period of those authorisations was extended until 17 July 1999. In certain cases the authorisation of bacitracin zinc was granted 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 bacitracin zinc 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 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 bacitracin zinc (the Swedish report). At point B.10 (p. 244) of that report, the following conclusions were drawn as regards bacitracin zinc:

Bacitracin has a bactericidal effect mainly on gram-positive bacteria, by inhibiting the formation of bacterial cell wall peptidoglycan. It is used, albeit not to any large extent, in both human and animal therapy. Lately it has been increasingly used for the treatment of vancomycin-resistant enterococci in humans.

In-feed bacitracin affects the antimicrobial resistance of the intestinal microflora, mainly in E. faecium but possibly also in other species.

Data available on colonisation by enteric pathogens in animals fed bacitracin [are] too inconsistent and too scarce to form the basis of any firm conclusions about the effects of bacitracin.

Bacitracin administered at growth promoting concentrations has prophylactic and therapeutic effects on necrotic enteritis in poultry.

Allergic reactions to bacitracin are documented in humans undergoing bacitracin treatment. People who are exposed to the substance on a daily basis may be at risk of being sensitised.

Bacitracin is degraded in soil. The environmental degradation appears to be inversely related to soil temperature.

In conclusion, available information is too scarce for an assessment of the possible risks of bacitracin usage to human and animal health. Bacitracin usage does not appear to represent any substantial danger to the environment.

45 Following those requests for adaptation, the Standing Committee discussed the Swedish report on a number of occasions. Similarly, that report was included on the agenda of a number of SCAN meetings. At the meeting held on 16 and 17 April 1998, the SSC decided to set up a multidisciplinary working group to examine the problem of antibiotic resistance and to present a report on the subject towards the middle of 1999.

46 On 6 June 1998, Alpharma, pursuant to Articles 9g(2) and 9h(2) of Directive 70/524, lodged new applications for the authorisation of bacitracin zinc as an additive the authorisation of which is linked to a person responsible for putting it into circulation.

47 Following the request for adaptation of Directive 70/524 presented by the Swedish authorities and the setting-up of the Surveillance Programme (see paragraph 38 above), on 21 August 1998 Alpharma sent the United Kingdom of Great Britain and Northern Ireland, the Member State acting as rapporteur for the purposes of the application for authorisation of bacitracin zinc, information concerning the resistance to that product. At Alpharma's request, the United Kingdom forwarded that information to the Commission, the member States of the European Economic Area, the members of SCAN and the members of the Standing Committee.

48 On 5 November 1998, Alpharma was informed by the Fédération européenne des fabricants d'adjuvants pour la nutrition animale (Fefana) that the Commission had drawn up a draft proposal for a regulation including bacitracin zinc on the list of antibiotics banned as additives in feedingstuffs. That was confirmed to Alpharma on 6 November 1998 by the Belgian member of the Standing Committee. On 9 November 1998, Alpharma received a copy of the Commission's draft proposal from the same member of the Standing Committee.

49 Between 10 November and 13 December 1998, Alpharma sent a large number of letters, together with scientific opinions, to Mr Fischler, the Member of the Commission responsible for agriculture, to the authorities of the United Kingdom (the Member State acting as rapporteur), to the United Kingdom member of the Standing Committee, to certain other authorities of the Member States and to the Commission, expressing its concern about the proposal to ban bacitracin zinc and requesting a hearing by the Commission on the subject.

50 On 12 November 1998, a meeting was held between, in particular, Alpharma, the Commission services dealing with the matter and members of Mr Fischler's cabinet.

51 On 30 November 1998, the Commission services informed Alpharma that its observations would be taken into account when the draft regulation was being examined.

52 On 11 December 1998, a second meeting took place between Alpharma and the responsible services of the Commission.

III - The contested regulation

53 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:

- bacitracin zinc,

...

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.

....

54 Recital 22 to the contested regulation is worded as follows:

Whereas bacitracin zinc, a cyclic polypeptide, is also used in human medicine mainly for topical treatment of infections of the skin and mucosal surfaces; whereas publications show that it could possibly be used for the treatment of vancomycin resistant enterococci, which represent a clinical problem in human medicine; whereas selected resistances from the use of bacitracin zinc as a feed additive inevitably increase the reservoir of resistances to bacitracin zinc; whereas the percentage of [E. faecium] resistant to bacitracin zinc is higher in chickens which have received bacitracin zinc than in chickens which have not received it; whereas these resistances could be transferred from animals to humans and reduce the effectiveness of bacitracin zinc used as a human medicinal product; whereas the effectiveness of bacitracin zinc in human medicine should therefore be preserved.

Procedure

55 By application lodged at the Registry of the Court of First Instance on 11 March 1999, Alpharma brought the present action.

56 By separate document lodged at the Court Registry on 14 April 1999, the Council raised an objection of inadmissibility pursuant to Article 114(1) of the Rules of Procedure of the Court of First Instance. 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 Council, which the Council answered within the period allowed.

57 By separate document lodged at the Court Registry on 11 March 1999, Alpharma also applied, pursuant to Articles 185 and 186 of the EC Treaty (now Articles 242 EC and 243 EC), first, for suspension of operation of the contested regulation pending judgment in the main action and, second, for the adoption of any other measures deemed appropriate. By order of 30 June 1999 in Case T-70/99 R Alpharma v Council [1999] ECR II-2027, the President of the Court of First Instance dismissed the application for interim relief.

58 Upon application by them, the President of the Third Chamber of the Court of First Instance, by orders of 19 May and 11 October 1999, granted the Commission, the Republic of Finland, the Kingdom of Sweden and the United Kingdom 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 10 August 1999 (the Commission) and 30 November 1999 (the United Kingdom). By letter of 16 August 1999, the Republic of Finland stated that it did not intend to lodge observations as to admissibility. The Kingdom of Sweden did not lodge observations on admissibility within the period allowed. 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) and 25 July 2000 (the Commission).

59 The written procedure was closed by the lodging of the rejoinder on 10 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 January and on 20 and 27 June 2001, the Court called on the parties to reply to certain questions and to produce certain documents. The parties complied with those requests.

60 The parties were heard in oral argument and answered questions put to them by the Court at the hearing on 3 July 2001. At the hearing the Court asked the Council and the Commission to produce documents. Once they had complied with that request, Alpharma was requested to submit its observations on those documents. On 4 September 2001, the President of the Third Chamber of the Court of First Instance closed the oral procedure.

Forms of order sought

61 Alpharma claims that the Court should:

- annul Regulation No 2821/98 in its entirety or in so far as it concerns bacitracin zinc;

- order the Council to pay the costs.

62 The Council contends that the Court should:

- dismiss the action as manifestly inadmissible;

- in the alternative, dismiss the action as unfounded;

- order Alpharma to pay the costs.

63 The Commission, the Kingdom of Sweden, the Republic of Finland and the United Kingdom of Great Britain and Northern Ireland, interveners, support the form of order sought by the Council.

Admissibility

Arguments of the parties

64 The Council begins by observing that Alpharma, 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.

65 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.

66 In the alternative, the Council contends that the contested regulation is not of individual concern to Alpharma 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 bacitracin zinc, in particular, there is nothing to distinguish Alpharma 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.

67 Nor can the action be considered admissible on account of the contacts which Alpharma 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.

68 In particular, according to the Council, the fact that Alpharma participated in the procedure laid down by Articles 9g and 9h of Directive 70/524, as inserted by Directive 96/51, does not mean that Alpharma is individually concerned by the contested regulation. The re-evaluation procedure is undertaken between the Member State acting as rapporteur and the Commission. Referring to Case 38/64 Getreide-Import v Commission [1965] ECR 203, the Council adds that the fact that Alpharma was the only undertaking to apply for authorisation of bacitracin zinc with a view to its re-evaluation pursuant to Articles 9g and 9h does not alter that conclusion. There is a fundamental difference between the re-evaluation procedure and the procedure which led to the adoption of the contested regulation. Whereas the re-evaluation procedure would have led to the adoption of an act marking the conclusion of an individual procedure following the application for authorisation submitted by Alpharma itself, the contested regulation has a different legal basis and an entirely different objective. Furthermore, unlike the situation in Case T-120/96 Lilly Industries v Commission [1998] ECR II-2571, Alpharma played no part in the procedure.

69 Alpharma'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 Alpharma or by anyone else under a different name. Therefore Alpharma 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.

70 The Commission adds that, as regards the nature of the contested regulation, it is purely by chance that there was only one producer of bacitracin zinc in the European Economic Area. The fact that Alpharma was the only manufacturer of bacitracin zinc there did not mean that it had a manufacturing monopoly and there was nothing to prevent another undertaking from manufacturing the substance concerned.

71 The United Kingdom contends in particular that Alpharma is not differentiated from all other persons by reason of being the only one to have submitted an application for re-evaluation under Article 9g. Following the adoption of the contested regulation, neither Alpharma nor any other trader could submit an application for authorisation, whether it was based on Article 9g, in Alpharma's case, or on Article 4, in the case of any other trader. Nor is Alpharma individually concerned because it participated in the administrative procedure. In the present case, the applicable legislation contains no specific provision requiring the Community institutions to take Alpharma's specific situation into account.

72 Alpharma maintains that the contested regulation is in the nature of a decision addressed to it. In any event, Alpharma is directly and individually concerned by the measure.

Findings of the Court

73 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).

74 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).

75 In this instance the contested regulation provides for withdrawal of the authorisation to market certain additives in feedingstuffs, including bacitracin zinc, 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.

76 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, cited at paragraph 69 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).

77 In so far as the contested regulation concerns additives other than bacitracin zinc which are not manufactured by Alpharma, the Court finds that it does not have any effect on Alpharma'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 bacitracin zinc.

78 As regards the requirement that the contested regulation should be of direct concern in so far as it concerns bacitracin zinc, 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).

79 As the Council recognises, Alpharma is directly concerned by the contested regulation in so far as it withdraws the authorisation of bacitracin zinc 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 Alpharma's authorisation to market that substance.

80 As to whether Alpharma is individually concerned by the contested regulation in so far as it concerns bacitracin zinc, 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 69 above, paragraph 20; and Case T-12/93 CCE de Vittel and Others v Commission [1995] ECR II-1247, paragraph 36).

81 Contrary to Alpharma's submission, the fact that at the time when the contested regulation was adopted Alpharma was the only manufacturer and by far the largest supplier of bacitracin zinc in the European Economic Area is not, in itself, such as to distinguish Alpharma 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 (judgment in Case C-213/91 Albertal 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).

82 However, it is appropriate to analyse the provisions under which the contested regulation was adopted in so far as the latter concerns bacitracin zinc in order to ascertain whether Alpharma 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.

83 Although the withdrawal of the authorisation of bacitracin zinc was adopted on the basis of the procedure laid down in Article 23 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 22 to 24 above).

84 Bacitracin zinc 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 Alpharma has pointed out, competitors had material difficulties in producing and marketing bacitracin zinc, from a legal standpoint any natural or legal person who met the abovementioned criteria could market it.

85 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.

86 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.

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

88 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.

89 In the present case Alpharma, the only producer and largest supplier of bacitracin zinc in the European Economic Area, made applications on 6 June 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, Alpharma 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 bacitracin zinc 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 bacitracin zinc, as provided for in Article 2 of the contested regulation, that product had been authorised again, only Alpharma, following the re-opening of the re-evaluation procedure, would have been in a position to obtain a new authorisation of bacitracin zinc 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 bacitracin zinc into circulation, since the re-evaluation procedure laid down by Directive 96/51 was still continuing, Alpharma was already able to rely on an inchoate right in that regard.

90 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, Alpharma 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 69 above).

91 Therefore, under the broad scheme of Directive 70/524, as amended by Directive 96/51, manufacturers who, like Alpharma, 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, those manufacturers 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.

92 Consequently, even before the end of the transitional period, Alpharma was affected by withdrawal of the authorisation of bacitracin zinc 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.

93 As to Alpharma'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 23 of Directive 70/524 and that that provision does not entitle the traders concerned to take part in the procedure (see paragraph 17 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 76 above; and the order in Case T-585/93 Greenpeace and Others v Commission [1995] ECR II-2205, paragraphs 56 and 63).

94 Account must nevertheless be taken of the fact that, by making new applications for authorisation of bacitracin zinc in accordance with paragraphs (2) and (4) of Article 9g of Directive 70/524, as amended by Directive 96/51, Alpharma 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.

95 Although it is true, as the Council has pointed out, that the procedure in Article 23 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 Alpharma's application for a new authorisation.

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

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

98 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 bacitracin zinc as an additive in feedingstuffs.

Substance

99 Alpharma puts forward four pleas in law alleging, respectively, breach of essential procedural requirements (first plea), manifest errors of assessment (second plea), infringement of fundamental principles of Community law (third plea) and breach of the obligation to state reasons (fourth plea).

100 In the context of the plea alleging manifest errors of assessment, Alpharma relies essentially on errors, first, in the risk assessment and, second, in the application of the precautionary principle. By the plea alleging infringement of essential principles of Community law, it claims that the contested regulation breaches the principles of proportionality and protection of legitimate expectations and that it breaches the rights of the defence. A number of the arguments raised in relation to those pleas overlap.

101 The Court considers it appropriate to deal with those pleas in a different order and will begin by examining the plea alleging breach of essential procedural requirements (I). It will then analyse the plea alleging manifest errors of assessment in so far as it concerns the claim that the Community institutions did not properly assess the risks associated with the use of bacitracin zinc as an additive in feedingstuffs. In doing so, the Court will take account of a number of the arguments put forward in the second part of that plea (II). Then, taking into account the remaining arguments put forward in the context of the second part of the second plea, relating to errors in the application of the precautionary principle, the Court will consider whether the contested regulation is vitiated by a breach of the principle of proportionality (III) and the principle of protection of legitimate expectations (IV) and whether it was adopted in breach of Alpharma's rights of defence (V). Last, it will consider whether the contested regulation breaches the obligation to state reasons (VI).

I - Breach of essential procedural requirements

102 This plea consists of two parts. First, Alpharma alleges that the contested regulation has no clear legal basis. Second, it maintains that the contested regulation has an illegal combination of legal bases.

A - The absence of a clear legal basis

103 First, Alpharma maintains that in the present case Article 151 of the Act of Accession cannot as such constitute the appropriate legal basis of the contested regulation. It submits that that provision merely authorises the Kingdom of Sweden to maintain in force for a transitional period its national legislation banning the use of antibiotics as growth promoters and does not confer power on the Council to impose such a ban at Community level.

104 The Court finds that it follows from the preamble thereto that the contested regulation was adopted on the basis of Article 151 of the Act of Accession in conjunction with point E1(4) of Title VII of Annex XV to the Act of Accession, and of Article 11(3) of Directive 70/524. As regards bacitracin zinc, it is common ground between the parties that, since no safeguard measures had been taken in respect of that product, the contested regulation cannot have been adopted on the basis of Article 11(3) of Directive 70/524.

105 It is necessary to consider, therefore, whether Article 151 of the Act of Accession, in conjunction with point E1(4) of Title VII of Annex XV thereto, could constitute an appropriate legal basis for the adoption of the contested regulation in so far as it relates to bacitracin zinc.

106 In the context of the organisation of the powers of the Community the choice of a legal basis for a measure must rest on objective factors which are amenable to judicial review. Those factors include in particular the aim and the content of the measure (Case C-36/98 Spain v Council [2001] ECR I-779, paragraph 58; Case C-269/97 Commission v Council [2000] ECR I-2257, paragraph 43; Case C-300/89 Commission v Council [1991] ECR I-2867, paragraph 10; and Case T-106/96 Wirtschaftsvereinigung Stahl v Commission [1999] ECR II-2155, paragraph 109).

107 A provision of an Act of Accession may serve as the legal basis on which to adopt legislative measures (see, to that effect, Case C-259/95 Parliament v Council [1997] ECR I-5303, concerning the legality of a Council Decision adopted on the basis of an Act of Accession).

108 It follows from the first subparagraph of point E1(4) of Title VII of Annex XV to the Act of Accession (see paragraph 2 above) that the first subparagraph, together with Article 151 of that Act (see paragraph 1 above), constitutes the legal basis on which the Kingdom of Sweden may, during a transitional period, derogate from the provisions of Directive 70/524. On the other hand, the second subparagraph of point E1(4) of Title VII of Annex XV to the Act of Accession, in conjunction with Article 151 of the Act of Accession, constitutes a specific legal basis on which the Community institutions may adopt appropriate measures for the purpose of ensuring the uniform application of Directive 70/524 in all Member States at the end of the transitional period, i.e. after 31 December 1998. It is not disputed that in the present case both the aim and the terms of the contested regulation were consistent with that purpose.

109 It follows that Article 151 of the Act of Accession, in conjunction with point E1(4) of Title VII of Annex XV thereto, could serve as the legal basis for the adoption of the contested regulation.

110 Second, Alpharma submits that, even if Article 151 of the Act of Accession, in conjunction with point E1(4) of Title VII of Annex XV thereto, could serve as the legal basis for the contested regulation, that legal basis was not sufficiently precise as regards the procedure to be followed in adopting that regulation. It states that the second subparagraph of point E1(4) of Title VII of Annex XV to the Act of Accession refers to Article 7 of Directive 70/524/EEC, which at the time when the contested regulation was adopted had already been repealed by Directive 96/51 and replaced by other provisions, notably Article 9m. In referring to Article 2 of Directive 96/51 (see paragraph 6 above), Alpharma observes that when the contested regulation was adopted Article 9m was not yet in force. It further states that that provision is not referred to in the contested regulation.

111 In those circumstances, according to Alpharma, the contested regulation must be annulled in so far as the Council failed to meet its obligation to state clearly the legal basis of the contested regulation (Case C-325/91 France v Commission [1993] ECR I-3283, paragraph 26). In the absence of such a clear indication of the legal basis for withdrawing the authorisation of bacitracin zinc, Alpharma maintains that it is left uncertain as to the legal basis of the regulation (Case 45/86 Commission v Council [1987] ECR 1493, paragraph 9). In particular, it submits, with reference to Case C-143/93 Van Es Douane Agenten [1996] ECR I-431, paragraphs 27 to 32, that, in essence, in a situation such as this, where certain provisions of a measure to which reference is made in other measures are amended, the Community institutions are required at the same time to make all the necessary consequential amendments to those other measures, in order to ensure a sufficient degree of legal certainty as to the applicable conditions for the parties concerned.

112 The Court recalls, first of all, that the principle of legal certainty, which is a general principle of Community law, requires Community legislation to be clear and its application foreseeable for all interested parties. As a result of that requirement, the binding nature of any act intended to have legal effects must be derived from a provision of Community law which prescribes the legal form to be taken by that act and which must be expressly indicated therein as its legal basis (France v Commission, cited above, paragraph 26). However, the Court of Justice has also held that failure to refer to a precise provision of the Treaty need not necessarily constitute an infringement of essential procedural requirements when the legal basis for the measure may be determined from other parts of the measure. However, explicit reference is indispensable where, in its absence, the parties concerned and the Court are left uncertain as to the precise legal basis (Commission v Council, cited in the preceding paragraph, paragraph 9).

113 In the present case, the second subparagraph of point E1(4) of Title VII of Annex XV to the Act of Accession provides that a decision on a request for adaptation of the Community legislation presented by the Swedish authorities is to be taken in accordance with the procedure laid down in Article 7 of Directive 70/524/EEC. Article 7 of that directive, which was repealed by Article 1(4) of Directive 96/51, provided in paragraph 1 that [a]mendments to be made to Annexes ... shall be adopted in accordance with the procedure laid down in Article 23. Article 7(2) of Directive 70/524 set out the conditions on which the annexes to that directive could be amended (see paragraphs 17 and 18 above).

114 It is quite clear from the second subparagraph of point E1(4) of Title VII of Annex XV to the Act of Accession that the reference to the former Article 7 of Directive 70/524 concerned only the procedure to be followed when requests for adaptation of the Community legislation were presented by the Swedish authorities. In that regard, the reference to the former Article 7(1) of Directive 70/524 in reality constituted only an indirect reference to Article 23 of that directive, cited at paragraph 17 above, which lays down the procedure to be followed when one of the annexes to that directive is to be amended and which was not amended by Directive 96/51.

115 It follows from recital 35 to the contested regulation, when read in context, that when withdrawing the authorisation of bacitracin zinc the Community authorities applied the procedure laid down in Article 23 of Directive 70/524.

116 Furthermore, contrary to what Alpharma appears to be arguing, Article 9m of Directive 70/524, as inserted by Directive 96/51, defines the circumstances in which authorisation of an additive is to be withdrawn under the new rules. It is not concerned with the procedure to be followed when authorisation is withdrawn. That procedural aspect is governed by the new Article 9r of Directive 70/524, which in that regard is identical to the former Article 7(1) of that directive, in so far as it states that [a]mendments to be made to the Annexes shall be adopted in accordance with the procedure laid down in Article 23.

117 It follows that neither Alpharma nor the Court is left uncertain as to the procedure to be followed in order to withdraw the authorisation of bacitracin zinc. That conclusion is also confirmed by Alpharma's own arguments, in particular those relating to the allegedly illegal combination of legal bases in so far as, in that context, Alpharma seeks to establish that the Community institutions did not properly follow the procedure laid down in Article 23 of Directive 70/524 (see paragraphs 123 to 130 below).

118 Alpharma further submits that Article 9m of Directive 70/524, as amended by Directive 96/51, is not mentioned in the preamble to the contested regulation.

119 In that regard, the Court observes, first of all, that Article 9m of Directive 70/524, cited by Alpharma, and also Article 9r of that directive constitute legal bases for the adoption of the contested regulation (see the case-law cited at paragraph 111 above). Next, contrary to Alpharma's argument that the new Article 9m of Directive 70/524, as regards the decision adopted by the Community institutions, became fully effective only from 1 April 1998, Articles 9m and 9r of that directive entered into force on 7 October 1996, in accordance with Article 191(2) of the EC Treaty (now Article 254(2) EC), i.e. well before the contested regulation was adopted (see paragraph 5 above). Article 2(1)(a) of Directive 96/51, cited by Alpharma in support of that argument, concerns not the entry into force of that directive but the date on which, in derogation from Article 2(1)(b) thereof, Member States were required to comply with certain provisions of the directive (see paragraph 6 above).

120 None the less, it is apparent that the absence of any express reference to those two provisions in the preamble to the contested regulation as the legal bases for its adoption cannot constitute a substantive defect. As regards Article 9m of Directive 70/524, as amended by Directive 96/51, it follows from recital 5 to the contested regulation that the Community institutions took the view that one of the conditions laid down in Article 3a of that directive for the authorisation of the antibiotics concerned, including bacitracin zinc, was no longer met. It follows, by implication but necessarily, that the Community institutions relied on the second indent of the first subparagraph of Article 9m of Directive 70/524, which provides that a regulation is to be adopted to withdraw the authorisation of an additive if any of the conditions for the authorisation of the additive referred to in Article 3a are no longer met.

121 So far as Article 9r of Directive 70/524, as amended by Directive 96/51, is concerned, the Court has already held at paragraph 117 above that the fact that that provision forms the legal basis of the contested regulation as regards the procedure to be followed is borne out by other aspects of the regulation, namely the express reference to Article 23 of Directive 70/524 in recital 35 to the contested regulation.

122 The first part of this plea in law is therefore unfounded.

B - The combination of legal bases

123 In the alternative, Alpharma submits that, in order to adopt the contested regulation, the Community institutions had to apply two different procedures. First, it was necessary, in the case of additives other than bacitracin zinc, to follow the procedure laid down in Article 24 of Directive 70/524 in order to withdraw an additive in respect of which a safeguard measure had been taken by a Member State. Second, in the case of bacitracin zinc, the Community institutions had to apply the procedure laid down in Article 23 of that directive, since no safeguard measure had been taken in respect of that product. Alpharma submits that the essential difference between those two procedures is that under the procedure laid down in Article 24 of Directive 70/524 the periods within which the merits of the measure taken by the Member State are to be examined are much shorter than those prescribed by Article 23 of that directive.

124 Alpharma maintains that in the present case the Community institutions in reality followed the procedure laid down in Article 24 of Directive 70/524 in respect of all the products concerned by the contested regulation, including bacitracin zinc, and thus deprived Alpharma of the advantages of the procedure laid down in Article 23 of that directive. If the Community institutions had not accelerated the procedure in order to comply with time-limits laid down in Article 24 of Directive 70/524, when they were required to apply Article 23 of that directive in respect of bacitracin zinc, the authorisation of bacitracin zinc would probably not have been withdrawn. Alpharma maintains, first, that if the period of three months, as prescribed in Article 23(3) of Directive 70/524, within which the Council must adopt the measure proposed by the Commission, had been applied rather than the period of 15 days prescribed in Article 24(3) of that directive, the Council and the Standing Committee would have been able to examine the Commission's proposal thoroughly and