Keywords

Summary



Keywords

1 Agriculture - Approximation of laws - Prohibition on the marketing of beta-agonists for administering to production livestock - Directive 96/22 - Whether in breach of the principles of proportionality, protection of legitimate expectations and sound administration - Whether in breach of the requirement that the European Parliament be consulted - No such breach

(EC Treaty, Art. 43 (now, after amendment, Art. 37 EC); Council Directive 96/22)

2 Actions for annulment - Interest in bringing proceedings - Natural or legal persons - Measures of direct and individual concern to them - Regulation restricting the validity of maximum residue limits for a veterinary medicinal product to certain therapeutic uses - Action brought by a pharmaceutical undertaking which was involved in the procedure for establishing such limits and whose marketing authorisations in respect of the product were subsequently withdrawn - Admissible

(Commission Regulation No 1312/96)

3 Procedure - Intervention - Leave sought on the basis of arguments which are new but do not alter the context of the dispute and which are intended to support the form of order sought by one of the parties - Whether admissible - To be determined on a case-by-case basis

(EC Statute of the Court of Justice, Art. 37, third para.; Rules of Procedure of the Court of First Instance, Art. 116(3))

4 Agriculture - Uniform legislation - Maximum residue limits of veterinary medicinal products in foodstuffs of animal origin - Procedure for establishing limits - Regulation No 2377/90 - Restricted purpose - Whether a ban on the use of the product may be taken into account - Not permissible - Where the validity of maximum residue limits is limited on the basis of such a ban - Ultra vires

(Council Regulations Nos 2377/90 and 2309/93; Commission Regulation No 1312/96; Council Directive 81/851)

Summary

1 Directive 96/22 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists neither breaches the principles of proportionality, the protection of legitimate expectations or sound administration nor infringes Article 43 of the Treaty (now, after amendment, Article 37 EC) in providing that Member States are to prohibit the placing on the market of beta-agonists for administering to animals the flesh and products of which are intended for human consumption and in drawing no distinction between the use of beta-agonists for unlawful purposes - fattening cattle - and their use for (hitherto) lawful therapeutic purposes.

As regards the principle of proportionality, the Council - in the light of the dual objective pursued, that is to say, the protection of public health and the attainment of the aims of the common agricultural policy - did not make a manifest error of assessment either in holding that the general prohibition constituted the preferable solution from the point of view of protecting public health or in considering that only a general prohibition was capable of restoring consumer confidence. Nor do the restrictions imposed on the economic exploitation of veterinary medicinal products developed by certain pharmaceutical undertakings in the past, and no longer protected by a patent, amount to a disproportionate or intolerable sacrifice in relation to the aforementioned objectives pursued in the public interest.

As regards the principles of protection of legitimate expectations and of sound administration, the Council was entitled, given the absence of specific assurances concerning the criteria for refusing marketing authorisation, to impose a prohibition such as the one at issue for the future and to decide that a ban was the most appropriate means of protecting human health and allaying consumer anxieties.

So far as concerns due consultation of the European Parliament, required under Article 43 of the Treaty, the amendments made after the proposal for the measure had been submitted to the Parliament - namely, adoption of a directive instead of a regulation and introduction of a minor derogation - do not constitute material amendments requiring fresh consultation.

2 An action brought by a pharmaceutical undertaking which manufactures and markets, under marketing authorisations issued in several Member States, veterinary medicinal products containing clenbuterol for annulment of Regulation No 1312/96 amending Annex III to Regulation No 2377/90 and establishing maximum residue limits for clenbuterol, but exclusively for certain, very specific, therapeutic purposes, cannot be held inadmissible on the ground that the applicant lacks a right of action or on the ground that it is neither individually nor directly concerned by that measure.

First, in so far as the amendment restricts the validity of clenbuterol maximum residue limits to certain precise therapeutic indications, it is equivalent to a prohibition on the use of that product for any other therapeutic indication, and thus to a partial withdrawal of the marketing authorisations which that applicant holds in a number of Member States. The Regulation thus produces binding legal effects such as to affect the interests of an applicant by bringing about a distinct change in his legal position.

Secondly, in so far as the Regulation was adopted after a formal request by the applicant that a maximum residue limit be fixed for clenbuterol, and in so far as that measure expressly provides that the applicant - being the undertaking responsible for the marketing of the veterinary medicinal products concerned - should be involved in the procedure for establishing such limits, the applicant is affected by that measure by reason of certain attributes peculiar to it and thus finds itself in factual circumstances which differentiate it, as far as that regulation is concerned, from all other persons. The applicant is therefore individually concerned by the Regulation. Moreover, in so far as the Regulation does not require any measures for its transposition into national law and directly affects all the traders concerned, the applicant is also directly concerned by that measure.

3 The third paragraph of Article 37 of the Statute of the Court of Justice (under which submissions made in an application to intervene must be limited to supporting the submissions of one of the parties) and Article 116(3) of the Rules of Procedure of the Court of First Instance (under which the intervener must accept the case as he finds it at the time of his intervention) do not preclude the intervener from advancing arguments which are new or which differ from those of the party he supports, provided that those arguments do not alter the context of the dispute and that the intervention is always intended to support the form of order sought by the latter.

The context of a dispute as delimited in an application for annulment is not altered by a line of argument, introduced for the first time by the intervener, to the effect that the defendant exceeded its powers, where the applicant has maintained that the exercise of its property rights and its freedom to pursue trade and professional activities had been unlawfully interfered with. If the misuse of power alleged is established, it would necessarily follow that there has been unlawful interference in the exercise of those rights.

4 The procedure for establishing maximum residue limits of veterinary medicinal products in foodstuffs of animal origin, set out in Regulation No 2377/90, is limited to the determination of the threshold below which residues of a given product, present in or on foodstuffs, may be regarded as posing no danger to human health. If the institutions nevertheless consider that they have other reasons for prohibiting the marketing of the product in question - such as the protection of human health against the unlawful use of a particular substance or the restoration of consumer confidence in that regard, they are under a duty to act by the appropriate means, such as the adoption of legislation prohibiting the placing of that product on the market.

Although Directive 81/851 and Regulation No 2309/93, which respectively govern the issue of national and Community marketing authorisations for veterinary medicinal products, expressly provide for the refusal of such authorisation where the use of the product is banned under other provisions of Community law, the procedure for establishing a maximum residue limit under Regulation No 2377/90 is independent of, and distinct from, the procedures for the issue of the marketing authorisations and that Regulation does not contain any provision permitting a marketing ban to be taken into account in order to refuse to establish a maximum residue limit.

It follows that, in Regulation No 1312/96, by limiting - on the basis of a prohibition of use laid down in a Council directive - the validity of the maximum residue limits established for clenbuterol to certain specified therapeutic indications for bovines and equidae, the Commission exceeded its powers under Regulation No 2377/90.