Language of document : ECLI:EU:T:1999:83


22 April 1999 (1)

(Regulation (EEC) No 2377/90 — Application to include a recombinant bovinesomatotrophin (BST) in the list of substances not subject to a maximum residuelimit — Rejection by the Commission — Action for annulment — Admissibility)

In Case T-112/97,

Monsanto Company, a company duly organised and existing under the laws of theState of Delaware (USA), with its seat in Saint-Louis, Missouri (USA), representedinitially by Clive Stanbrook QC and Robert MacLean, Solicitor, and subsequentlyby Mr Stanbrook and by Debra Holland, Barrister, with an address for service inLuxembourg at the Chambers of Arsène Kronshagen, 22 Rue Marie-Adélaïde,



Commission of the European Communities, represented initially by RichardWainwright, Principal Legal Adviser, and Fernando Castillo de la Torre, of itsLegal Service, acting as Agents, and subsequently by Richard Wainwright alone,with an address for service in Luxembourg at the office of Carlos Gómez de laCruz, of the Commission's Legal Service, Wagner Centre, Kirchberg,


supported by

French Republic, represented initially by Kareen Rispal-Bellanger, Head ofSubdirectorate in the Legal Affairs Directorate at the Ministry of Foreign Affairs,Frédéric Pascal, central administrative attaché, and Régine Loosli-Surrans, Chargéede Mission, and subsequently by Ms Rispal-Bellanger, Ms Loosli-Surrans andChristina Vasak, Assistant Secretary at the same ministry, acting as Agents, with anaddress for service in Luxembourg at the French Embassy, 8B Boulevard JosephII,


APPLICATION for the annulment of Commission Decision C(97) 148 final of 14January 1997, rejecting the application by Monsanto Europe SA/NV for theinclusion of Sometribove, a recombinant bovine somatotrophin (BST), in Annex IIto Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down aCommunity procedure for the establishment of maximum residue limits ofveterinary medicinal products in foodstuffs of animal origin (OJ 1990 L 224, p. 1).



composed of: A. Potocki, President, C.W. Bellamy and A.W.H. Meij, Judges,

Registrar: A. Mair, Administrator,

having regard to the written procedure and further to the hearing on 16 December1998,

gives the following


    Legislative background

    On 26 June 1990, the Council adopted Regulation (EEC) No 2377/90 of 26 June1990 laying down a Community procedure for the establishment of maximumresidue limits of veterinary medicinal products in foodstuffs of animal origin (OJ1990 L 224, p. 1; 'Regulation No 2377/90‘).

    Under that regulation, the Commission is to establish the maximum residue limit('MRL‘). Article 1(1)(b) of the regulation defines the MRL as the maximumconcentration of residue resulting from the use of a veterinary medicinal productwhich may be accepted by the Community to be legally permitted or recognised asacceptable 'in or on a food‘.

    Regulation No 2377/90 provides for the drawing up of four annexes in which apharmacologically active substance intended for use in veterinary medicinalproducts to be administered to 'food-producing animals‘ may be included:

—    Annex I, reserved for substances in respect of which a MRL may beestablished after assessment of the risks which that substance poses forhuman health;

—    Annex II, reserved for substances which are not subject to a MRL;

—    Annex III, reserved for substances in respect of which it is not possibledefinitively to establish a MRL, but which, without compromising humanhealth, may be given a provisional MRL for a given duration linked to thetime necessary to complete the appropriate scientific studies, such durationbeing capable of being extended only once;

—    Annex IV, reserved for substances in respect of which no MRL can beestablished because they constitute a risk to consumer health whatever thequantity.

    Article 6(1) of Regulation No 2377/90 provides:

'In order to obtain the inclusion in Annex I, II, or III of a new pharmacologicallyactive substance which is:

—    intended for use in veterinary medicinal products for administration tofood-producing animals,


—    intended to be placed on the market of one or more Member States whichhave not previously authorised the use of the substance concerned infood-producing animals,

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 theapplication is submitted in correct form, the Commission is 'forthwith‘ to submit

the application for examination by the Committee for Veterinary MedicinalProducts ('CVMP‘).

    Under Article 6(3), the Commission is required to prepare a draft of the measuresto be taken within 120 days of referral of the application to the CVMP, taking theobservations of the members of that committee into account.

    Under Article 6(5), the Commission has to submit that draft to the Committee forAdaptation to Technical Progress of the Directives on Veterinary MedicinalProducts ('the Regulatory Committee‘), for the procedure laid down in Article 8of the regulation to be applied.

    Under Article 8(2), that committee is to deliver its opinion on the draft within atime-limit set by its chairman, having regard to the urgency of the matter.

    Article 8(3) describes the procedure whereby the Commission, or in some cases theCouncil, is to adopt the measures envisaged, taking the opinion of the RegulatoryCommittee into account.

    Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Communityprocedures for the authorisation and supervision of medicinal products for humanand veterinary use and establishing a European Agency for the Evaluation ofMedicinal Products (OJ 1993 L 214, p. 1; 'Regulation No 2309/93‘) lays down aprocedure for the issuing of a Community marketing authorisation for a veterinarymedicinal product.

    In the case of a veterinary medicinal product intended for administration tofood-producing animals, Article 31(3)(b) of Regulation No 2309/93 makes it acondition for the issuing of a marketing authorisation that a MRL be establishedfor its pharmacologically active substance in accordance with Regulation (EEC) No2377/90.

    Under Article 34(2) of Regulation No 2309/93, refusal of a Community marketingauthorisation constitutes a prohibition on placing the veterinary medicinal productconcerned on the market throughout the Community.

    Council Directive 87/22/EEC of 22 December 1986 on the approximation ofnational measures relating to the placing on the market of high-technologymedicinal products, particularly those derived from biotechnology (OJ 1987 L 15,p. 38) provides, in Article 2(1), that, as soon as the competent authorities of theMember States receive an application for marketing authorisation relating to a hightechnology medicinal product, they are required, at the request of the personresponsible for placing the product on the market, to bring the matter before eitherthe Committee for Proprietary Medicinal Products or the CVMP, in accordancewith their competence, for an opinion.

    By Council Decision 90/218/EEC of 25 April 1990 concerning the administrationof bovine somatotrophin (BST) (OJ 1990 L 116, p. 27), as last amended by CouncilDecision 94/936/EC of 20 December 1994 (OJ 1994 L 366, p. 19), a moratoriumwas introduced on the placing on the market of recombinant bovine somatotrophin('BST‘), a growth hormone.

    Under the first paragraph of Article 1 of Decision 90/218, as amended by Decision94/936, Member States are required to ensure that, until 31 December 1999, theplacing on the market of BST for the purposes of its marketing and theadministration thereof on their territory to dairy cows by any means whatsoever willnot be authorised.

Factual background

    Monsanto Company has invented and developed a veterinary medicinal productcalled 'Somatech‘, the pharmacologically active substance of which is'Sometribove‘, a BST intended for administration to dairy cows to increase milkyield.

    Monsanto Europe SA/NV, a company incorporated under Belgian law ('MonsantoEurope‘) is a wholly-owned subsidiary of Monsanto Company. It is responsible forcertain aspects of the commercial exploitation of Sometribove in the Community,under the auspices of Monsanto Company, which is the worldwide coordinator ofthat exploitation.

    In 1987, at the request of Monsanto Europe and in accordance with Article 2(1)of Directive 87/22, the competent authorities of the French Republic referred tothe CVMP for an opinion on Sometribove.

    Following the entry into force of Regulation No 2377/90, the Commission informedMonsanto Europe that it did not need to submit a second application for theinclusion of Sometribove in Annex II to Regulation No 2377/90 ('Annex II‘), giventhat a file had already been submitted to the CVMP in accordance with Directive87/22.

    The CVMP gave its opinion on 27 January 1993.

    That opinion stated:

'The Committee considers that it is not necessary for the protection of publichealth to establish MRLs for Sometribove, the active ingredient in the product, andit therefore recommends that Sometribove should be included in the list ofsubstances not subject to maximum residue limits in Annex II ...‘

    By letter of 20 April 1995, the Veterinary Medicines Directorate in the UnitedKingdom informed Monsanto Europe that the Commission had prepared a draftregulation which included Sometribove as an Annex II substance. That draft wasthen to be submitted to the Regulatory Committee in accordance with Articles 6(5)and 8 of Regulation No 2377/90.

    However, at a meeting with Commission officials on 17 October 1995, the applicantwas informed that the Commission had 'removed this draft from the agenda‘because of the existence of the moratorium on BST.

    In those circumstances, one of the applicant's lawyers, by letter of 6 November1996, formally called upon the Commission, pursuant to Article 175 of the ECTreaty, 'to take the necessary steps to refer the matter without further delay to the[Regulatory Committee] in accordance with Regulation No 2377/90‘.

    Following that formal notice, the Commission adopted on 14 January 1997 Decision C(97) 148 final ('the contested decision‘).

    The fourth, fifth, sixth and seventh recitals in the preamble to that decision, and itsoperative part, provide:

'whereas, under Article 6 of Regulation No 2377/90, for a new pharmacologicallyactive substance to be capable of inclusion in one of the lists in the regulation itmust be intended to be used in a veterinary medicinal product and placed on themarket of one or more Member States;

whereas, on 20 December 1994, the Council adopted Decision 94/936 of 20December 1994 amending Decision 90/218 of 25 April 1990 concerning theadministration of bovine somatotrophin (BST);

    whereas Article 1 of the decision provides: ”Member States shall ensure that, until31 December 1999, the placing on the market of bovine somatotrophin for thepurposes of its marketing and the administration thereof on their territory to dairycows by any means whatsoever will not be authorised”, and therefore bovinesomatotrophin can be neither placed on the market nor administered in theCommunity, since it is administered only to dairy cows;

whereas, since one of the conditions to be fulfilled in order to apply for inclusionin the annexes to Regulation No 2377/90 has not been met, and the applicant hasno interest in obtaining such inclusion, the Commission considers that it is notobliged to grant the request made on 6 November 1996, although without prejudiceto a reassessment of the situation, should circumstances change;

[the Commission] has adopted the following decision:

Article 1

The application to include Sometribove (bovine somatotrophin) in Annex II toCouncil Regulation No 2377/90 is rejected.

Article 2

The Monsanto Company, Avenue de Tervuren 270-272, 1040 Brussels, Belgium, isthe addressee of this decision.‘

    On 23 January 1997, the contested decision was notified to Monsanto Europe inBrussels.

Procedure and forms of order sought

    By application lodged at the Registry of the Court of First Instance on 14 April1997, Monsanto Company brought the present action.

    By a document registered at the Registry of the Court of First Instance on 12August 1997, the French Republic requested leave to intervene in support of theform of order sought by the Commission. That leave was granted by order of thePresident of the Third Chamber of 29 September 1997.

    The applicant claims that the Court should:

—    annul the contested decision;

—    order the Commission to pay the costs.

    The Commission contends that the Court should:

—    dismiss the action as inadmissible;

—    in the alternative, dismiss it as unfounded;

—    order the applicant to pay the costs.

    The French Republic supports the form of order sought by the Commission.

Facts occurring after the action was brought, and the course of the procedure

    On 25 June 1998, the Court of First Instance (Third Chamber) delivered itsjudgment in Case T-120/96 Lilly Industries v Commission [1998] ECR II-2571('Lilly‘).

    At point 1 of the operative part of that judgment the Court of First Instance (ThirdChamber)

'[Annuled] the Commission decision of 22 May 1996 rejecting the request for theinclusion of Somidobove, a recombinant bovine somatotrophin (BST), in Annex IIto Council Regulation (EEC) No 2377/90 ...‘

    Since the Commission has not appealed against the judgment in Lilly within theperiod prescribed by law, that judgment has the force of res judicata.

    Finding that the factual and legal context of the two cases was similar, the Courtof First Instance (Third Chamber) invited the parties to submit any observationsthey might have concerning the consequences of that judgment for the presentproceedings.

    The Commission and the applicant replied to that invitation by letters of 3 and 6July 1998 respectively. The French Government did not submit any observationswithin the time allowed.

    The composition of the Chambers of the Court of First Instance having beenchanged as from the commencement of the new judicial year, the Judge-Rapporteur was assigned to the Second Chamber, to which this case was itselfaccordingly assigned.

    Upon hearing the report of the Judge-Rapporteur, the Court of First Instance(Second Chamber) decided to open the oral procedure without any preparatorymeasures of inquiry. The hearing in open court, at which the parties presented oralargument and replied to the questions of the Court, took place on 16 December1998.


    During the oral procedure, the applicant confirmed, in reply to a question from theCourt, that it brought the present action on its own account and not on behalf ofMonsanto Europe.

Arguments of the parties

    The Commission, supported by the French Republic, argues that, although in somecircumstances, in competition law for example, it might not be necessary to drawa distinction between a parent company and its subsidiary, that does not apply tothis case, in the area of veterinary medicines, in which Monsanto Company andMonsanto Europe occupy very different positions in terms of rights and obligations.

    In particular, procedural rights under Directive 87/22 and Regulations Nos 2377/90and 2309/93 are granted only to Monsanto Europe, since it was that company whichsubmitted applications under the administrative procedures laid down by thosemeasures. The fact that Monsanto Europe is a subsidiary of Monsanto Companyis in this respect entirely irrelevant, since that fact does not grant MonsantoCompany any right or create any obligation.

    In those circumstances, only Monsanto Europe, the addressee of the contesteddecision, is concerned by it. That company alone might be entitled to bring anadmissible action for its annulment.

    Monsanto Company, by contrast, could not bring an admissible action for theannulment of the contested decision, being neither its addressee nor directly andindividually concerned by it.

    As regards more particularly the question whether Monsanto Company is directlyaffected, the Commission argues that, unlike Monsanto Europe, MonsantoCompany does not have the right to obtain the inclusion of Sometribove in AnnexII and thus, a fortiori, cannot be the potential holder of a marketing authorisation.

    In the light of all the foregoing considerations, the Commission maintains that theaction must be declared inadmissible.

    The applicant does not accept the Commission's argument.

Findings of the Court

    As as a preliminary point, it should be observed that Monsanto Company inventedand developed Somatech. It is the parent company of Monsanto Europe and theworldwide coordinator of the commercial exploitation of Somatech. In thosecapacities, it has an obvious economic interest in one of the conditions necessaryfor the marketing of Somatech by Monsanto Europe in the Community beingfulfilled.

    Next, whilst the contested decision indicates 'la compagnie Monsanto‘ as itsaddressee, the decision was none the less sent to the registered office of MonsantoEurope in Brussels. Moreover, by that decision, the Commission ruled on theapplication by Monsanto Europe for the inclusion of Sometribove in Annex II. Inthose circumstances, Monsanto Europe must be regarded as the addressee of thecontested decision.

    In examining the admissibility of this application it is therefore necessary todetermine whether the applicant, while not being the addressee of the contested

decision, is directly and individually concerned by it within the meaning of thefourth paragraph of Article 173 of the Treaty.

    As regards, first, the question whether the applicant is directly concerned by thecontested decision, it should be observed at the outset that that decision does notleave any discretion to any authority concerning its implementation.

    Second, by rejecting Monsanto Europe's application for the inclusion ofSometribove in Annex II, the contested decision had as its direct consequence thata MRL for Sometribove was not established.

    It should be borne in mind in that regard that the establishment of a MRL forSometribove in accordance with Regulation No 2377/90 constitutes a sine qua nonfor the issuing of a marketing authorisation for Somatech, pursuant to Article31(3)(b) of Regulation No 2309/93.

    Whilst it is true that the mere establishment of a MRL does not automaticallymean that Somatech may legally be placed on the market (Lilly, paragraphs 88 to90), the refusal to fix such a limit entails, for its part, the refusal by the Communityof a marketing authorisation for Somatech, which in turn constitutes a prohibitionon placing Somatech on the market anywhere in the Community, pursuant toArticle 34(2) of the same regulation.

    In those circumstances, the direct effect of the contested decision is that, in theevent of the other conditions for marketing being satisfied, and, in particular, of themoratorium on BST being lifted (Lilly, paragraphs 65 to 67), Somatech cannot bemarketed in the Community.

    The applicant must therefore be regarded as directly concerned by the contesteddecision.

    As regards, second, the question whether the applicant is individually concerned bythe contested decision, it has been consistently held that natural or legal personsare to be regarded as individually concerned by a Community measure only if thatdecision affects them by reason of certain attributes which are peculiar to them, orby reason of factual circumstances which differentiate them from all other personsand thereby distinguish them individually in the same way as the person addressed(see, for example, the order of 9 August 1995 in Case T-585/93 Greenpeace andOthers v Commission [1995] ECR II-2205, paragraph 48, confirmed on appeal bythe judgment of the Court of Justice in Case C-321/95 P Greenpeace Council andOthers v Commission [1998] ECR I-1651).

    In this case, it is sufficient to note that the applicant holds all the shares inMonsanto Europe and is thus the sole owner of that undertaking. That statusdifferentiates the applicant, in relation to the contested decision, from all otherpersons and, in particular, from all other operators in the market in question.

    The applicant must therefore be regarded as individually concerned by thecontested decision.

    Since the applicant is directly and individually concerned by the contested decision,the action is admissible.


Arguments of the parties

    In its letter of 6 July 1998 (see paragraph 37 above), the applicant observed thatbecause of the similarity between the present case and that which gave rise to thejudgment in Lilly, this case should have an identical outcome, namely theannulment of the contested decision.

    In its letter of 3 July 1998 (see paragraph 37 above), the Commission acknowledgesthat the factual and legal context of the two cases is 'very similar‘. It concedesthat, in the event of the Court declaring the present action admissible, thecontested decision should be annulled for the same reasons that led the Court toannul the contested decision in Lilly.

Findings of the Court

    It is common ground between the parties that the contested decision must beannulled for the same reasons that led the Court to annul the contested decisionin Lilly.

    Since the Court has not found anything in fact or law which would permit adifferent conclusion, reference must be made to the grounds of its judgment in Lillyand the contested decision must, as a result, be annulled.


    Under Article 87(2) of the Rules of Procedure, the unsuccessful party is to beordered to pay the costs if they have been applied for in the successful party'spleadings. Under Article 87(4) of those rules, however, Member States whichintervene in the proceedings before the Court of First Instance are to bear theirown costs.

    Accordingly, since the Commission has been unsuccessful, and having regard to theform of order sought by the applicant, the Commission must be ordered to bear itsown costs and to pay those incurred by the applicant.

    The French Republic, which has intervened in the proceedings, must bear its owncosts.

On those grounds,



1.    Annuls Commission Decision C(97) 148 final of 14 January 1997, rejectingthe application by Monsanto Europe SA/NV for the inclusion ofSometribove in Annex II to Council Regulation (EEC) No 2377/90 of 26June 1990 laying down a Community procedure for the establishment ofmaximum residue limits of veterinary medicinal products in foodstuffs ofanimal origin.

2.    Orders the Commission to bear its own costs and to pay those incurred bythe applicant;

3.    Orders the French Republic to bear its own costs.



Delivered in open court in Luxembourg on 22 April 1999.

H. Jung

A. Potocki



1: Language of the case: English.