(Regulation (EEC) No 2377/90 · Application to include a recombinant bovine somatotrophin (BST) in the list of substances not subject to a maximum residue limit · Rejection by the Commission · Action for annulment ·Admissibility)
On 26 June 1990, the Council adopted Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (hereinafter 'Regulation No 2377/90'). Under that regulation, the Commission is to establish the maximum residue limit ('MRL') resulting from the use of a veterinary medicinal product which may be accepted by the Community to be legally permitted or recognised as acceptable 'in or on a food'.
Article 6(1) of Regulation No 2377/90 provides:
'In order to obtain the inclusion in Annex I, II, or III of a new pharmacologically active substance: the person responsible for marketing shall submit an application to the Commission ...'
Article 6(2) provides that, after verifying within a period of 30 days that the application is submitted in correct form, the Commission is 'forthwith' to submit the application for examination by the Committee for Veterinary Medicinal Products ('CVMP').
Monsanto Company has invented and developed a veterinary medicinal product called 'Somatech', the pharmacologically active substance of which is 'Sometribove', a growth hormone intended for administration to dairy cows to increase milk yield. Monsanto Europe SA/NV, a company incorporated under Belgian law ('Monsanto Europe') is a wholly-owned subsidiary of Monsanto Company. It is responsible for certain aspects of the commercial exploitation of Sometribove in the Community, under the auspices of Monsanto Company, which is the worldwide coordinator of that exploitation.
In 1987, at the request of Monsanto Europe, the competent authorities of the French Republic referred to the CVMP for an opinion on Sometribove. The CVMP gave its opinion on 27 January 1993. Whereas, since one of the conditions to be fulfilled in order to apply for inclusion in the annexes to Regulation No 2377/90 has not been met, and the applicant has no interest in obtaining such inclusion, the Commission has adopted on 14 January 1997 its decision, Article 1 of which provides: The application to include Sometribove (bovine somatotrophin) in Annex II to Council Regulation No 2377/90 is rejected.
By application lodged at the Registry of the Court of First Instance, Monsanto Company brought the present action. By a document lodged at the Registry of the Court of First Instance, the French Republic requested leave to intervene in support of the form of order sought by the Commission. That leave was granted by order of the President of the Third Chamber.
The applicant claims that the Court should: annul the contested decision.
On 25 June 1998, the Court of First Instance delivered its judgment in Case T-120/96 Lilly Industries v Commission ('Lilly').
At point 1 of the operative part of that judgment the Court of First Instance (Third Chamber)
'[Annulled] the Commission decision of 22 May 1996 rejecting the request for the inclusion of Somidobove, a recombinant bovine somatotrophin (BST), in Annex II to Council Regulation (EEC) No 2377/90 ...'
Since the Commission has not appealed against the judgment in Lilly within the period prescribed by law, that judgment has the force of res judicata.
Admissibility
Monsanto Company invented and developed Somatech. It is the parent company of Monsanto Europe and the worldwide coordinator of the commercial exploitation of Somatech. In those capacities, it has an obvious economic interest in one of the conditions necessary for the marketing of Somatech by Monsanto Europe in the Community being fulfilled. Monsanto Europe must be regarded as the addressee of the contested decision. It is therefore necessary to determine whether the applicant, while not being the addressee of the contested decision, is directly and individually concerned by it within the meaning of the fourth paragraph of Article 173 of the Treaty.
By rejecting Monsanto Europe's application for the inclusion of Sometribove in Annex II, the contested decision had as its direct consequence that a MRL for Sometribove was not established. It should be borne in mind in that regard that the establishment of a MRL for Sometribove in accordance with Regulation No 2377/90 constitutes a sine qua non for the issuing of a marketing authorisation for Somatech, pursuant to Article 31(3)(b) of Regulation No 2309/93. The refusal to fix such a MRL entails, for its part, the refusal by the Community of a marketing authorisation for Somatech, which in turn constitutes a prohibition on placing Somatech on the market anywhere in the Community, pursuant to Article 34(2) of the same regulation.
The direct effect of the contested decision is that, in the event of the other conditions for marketing being satisfied, and, in particular, of the moratorium on BST being lifted, Somatech cannot be marketed in the Community.
The applicant must therefore be regarded as directly concerned by the contested decision. It has been consistently held that natural or legal persons are to be regarded as individually concerned by a Community measure only if that decision affects them by reason of certain attributes which are peculiar to them, or by reason of factual circumstances which differentiate them from all other persons and thereby distinguish them individually in the same way as the person addressed.
In this case, it is sufficient to note that the applicant holds all the shares in Monsanto Europe and is thus the sole owner of that undertaking. That status differentiates the applicant, in relation to the contested decision, from all other persons and, in particular, from all other operators in the market in question. The applicant must therefore be regarded as individually concerned by the contested decision. Since the applicant is directly and individually concerned by the contested decision, the action is admissible.
Substance
It is common ground between the parties that the contested decision must be annulled for the same reasons that led the Court to annul the contested decision in Lilly.
The Court:
'1. Annuls Commission Decision C(97) 148 final of 14 January 1997, rejecting the application by Monsanto Europe SA/NV for the inclusion of Sometribove in Annex II to Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin.
2. Orders the Commission to bear its own costs and to pay those incurred by the applicant;
3. Orders the French Republic to bear its own costs.'