Alpharma Inc. v Council of the European Union.

• Jurisdiction: European Union
• ECLI: ECLI:EU:T:2002:210
• Court: General Court (European Union)
• Date: 11 September 2002
• Docket Number: T-70/99
• Celex Number: 61999TJ0070
• Procedure Type: Recurso de anulación - infundado

Avis juridique important

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61999A0070

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...