Judgments nº T-13/99 of Court of First Instance of the European Communities, September 11, 2002

• Resolution Date: September 11, 2002
• Issuing Organization: Court of First Instance of the European Communities
• Decision Number: T-13/99

JUDGMENT OF THE COURT OF FIRST INSTANCE (Third Chamber)

11 September 2002 (1) (Transfer of resistance to antibiotics from animals to humans - Directive 70/524/EEC - Regulation concerning the withdrawal of the authorisation of an additive in feedingstuffs - Admissibility - Article 11 of Directive 70/524/EEC - Manifest error of assessment - Precautionary principle - Risk assessment and risk management - Consultation of a scientific committee - Principle of proportionality - Legitimate expectations - Obligation to state reasons - Right to property - Misuse of powers)

In Case T-13/99,

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

applicant,

supported by

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

and

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

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

and by

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

and

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

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

interveners,

v

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

defendant,

supported by

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

by

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

by

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

by

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

and by

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

interveners,

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

THE COURT OF FIRST INSTANCE

OF THE EUROPEAN COMMUNITIES (Third Chamber),

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

Registrar: F. Erlbacher, Legal Secretary,

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

gives the following

Judgment

Legal framework

I - The Act of Accession

1.

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

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

2.

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

II - The Community rules on additives in feedingstuffs

A - General description

3.

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

4.

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

5.

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

6.

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

B - Definition of additives in feedingstuffs

7.

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

8.

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

‘(a) “additives”: substances or preparations used in animal nutrition in order to:

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

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

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

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

(aa) “micro-organisms”: micro-organisms forming colonies;

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

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

9.

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

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

1. The rules on authorisation of additives

10.

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

11.

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

‘...

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

12.

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

13.

Article 9 of Directive 70/524, as amended by Directive 96/51, provides that[a]dditives as referred to in Article 2(aaa) which meet the conditions laid down in Article 3a shall be authorised and included in Chapter I of the list referred to in Article 9t(b). Chapter I includes additives whose authorisation is linked to a person responsible for putting them into circulation and is granted for a period of 10 years. Under the new...