C-248/99

FRANCE v MONSANTO AND COMMISSION

OPINION OF ADVOCATE GENERAL ALBER delivered on 29 May 2001 1

Table of contents

I — Introduction I- 7 II •— Legal framework I- 7 A — The legal framework underlying the Commission decision at issue I- 7 ( 1 ) The marketing of a product I- 8 (a) Council Directive 81/851/EEC of 28 September 1981 on the approxi- mation of the laws of the Member States relating to veterinary medicinal products I- 8 (b) Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products I- 10 (2) 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 I- 10 (3)The moratorium on Somatotropin I- 13 B •— The Rules of Procedure of the Court of First Instance I- 14 III — Facts I- 15 IV — Procedure before the Court of First Instance I- 18 V — The judgment of the Court of First Instance I- 19 A — Findings in the case of Monsanto I- 19 B — The judgment in Lilly I- 20 C — The outcome of the Monsanto case I- 22 VI — The implementation to date of the judgments in Lilly and Monsanto by the Commission I- 23 VII— The appeal proceedings before the Court of Justice I- 23 VIII·—Legal assessment I- 24 A — Procedural objections I- 24 ( 1 ) Refusal to join the Lilly and Monsanto cases I- 25 (2) The absence of any request for information I- 26

(b)The entitlement of Monsanto to submit an application I- 34

Arguments of the parties I- 34

Assessment I- 35 (i) Interpretation of the first sentence of Article 6(1) of Regulation No 2377/90 I- 36 (ii) The moratorium I- 38 (iii) The saving of time I- 39 (iv) Conclusion I- 39 (c) The question whether the Commission was bound by the opinion of the Committee for Veterinary Medicinal Products I- 39 Arguments of the parties I- 39 I - Assessment 4 2 C — Adjudication on the appeal I- 44 IX — Costs I- I - 6— Proposed decision by the Court X I- 45

FRANCE v MONSANTO AND COMMISSION

I — Introduction time-limit. Second, it complains that the Court of First Instance based its judgment on the conclusion that Monsanto's case should be decided in exactly the same way as the case of Lilly.

4. It should be stated, as a preliminary observation, that a distinction must be 2. By its appeal, the French Republic com- drawn between the bringing into circu- plains, first, that certain procedural rules lation — that is to say, the marketing — have been infringed. Those infringements of a product (as in the case of Monsanto's concern, inter alia, the non-joinder of the original application in respect of its product case with Case T-l20/96 Lilly Industries v Somatech) and the inclusion (not initiated Commission, failure to gather information in the present case, from a chronological and a refusal to grant an extension of a standpoint, until after the submission of the

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application) in one of the annexes to unless a marketing authorisation has been Regulation No 2377/90 concerning maxi- issued by the competent authorities of that mum residue limits of a pharmacologically Member State in accordance with this active substance used in veterinary medici- Directive or a marketing authorisation has nal products (in this instance, Somatotro- been granted in accordance with Council pin, as in the case of Monsanto's tacitly Regulation (EEC) 2309/93 of 22 July 1993 reformulated, alternatively expanded, laying down Community procedures for application to the Commission). the authorisation and supervision of medicinal products for human and veterin- ary use and establishing an European Agency for the evaluation of medicinal products.

(1) The marketing of a product

(a) Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products 2 2. A Member State shall not authorise the placing on the market of a veterinary medicinal product intended for adminis- tration to food-producing animals whose 5. The material provisions for the purposes flesh or products are intended for human of the present case are the following: consumption, unless:

Articles 6 — 10 ... 3. — 5. ...

Article 11

Article 5

The authorisation provided for in Article 4 shall be withheld if examination of the documents and particulars listed in Article 5 establishes that: For the purpose of obtaining the auth- orisation for placing a product on the market provided for in Article 4, the person responsible for placing the product on the market shall lodge an application with the competent authority of the Member State. 1. — 2. ...

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7. Regulation No 2377/90 governs the procedure for inclusion of a substance in the annexes relating to maximum residue Without prejudice to other provisions of limits. Community law, the authorisation pro-

4 — OJ 1990 L 224, p. 1. The amendments subsequently made 3 — OJ 1993 L 214, p. 1. to this regulation are not applicable to the present case.

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8. Although the present case concerns only sumers, so that administering them to Annex II, the differences between the animals which are to be used for food various annexes are summarised below in production is likewise prohibited order to facilitate an understanding of the (Article 5 of the regulation). matter.

9. Article 3 of the regulation states as follows with regard to Annex II, which is — Annex I lists the substances for which, at issue in the present case: following assessment of the risks which they pose to human health, a maximum residue level has been fixed (Article 2 of the regulation). 'Where, following an evaluation of a phar- macologically active substance used in veterinary medicinal products, it appears that it is not necessary for the protection of public health to establish a maximum — Annex II sets out the substances not residue limit, that substance shall be subject to a maximum residue level included in a list in Annex II, which shall (Article 3 — see, in this regard, point 9 be adopted in accordance with the pro- below). cedure laid down in Article 8. ...'

a substance in an annex is to be examined mation and particulars referred to in by a committee of scientific experts — the Annex V and shall comply with the prin- 'Committee for Veterinary Medicinal Prod- ciples laid down in Directive 81/852/EEC. ucts' set up by Article 16 of Directive 81/851. According to Article 52 of Regu- lation No 2309/93, that committee is to be composed of scientists who are able to give a wholly objective scientific opinion on the application. 2. After verifying within a period of 30 days that the application is submitted in correct form, the Commission shall forth- with submit the application for examin- ation by the Committee for Veterinary 12. Article 6 of Regulation No 2377/90 Medicinal Products set up under Article 16 provides, specifically, as follows: of Directive 81/851/EEC. The Committee shall appoint one of its members to act as rapporteur and to undertake an initial evaluation of the application.

'1. In order to obtain the inclusion in Annex I, II, or III of a new pharmacologi- cally active substance which is:

3. Within 120 days of referral of the application to the Committee for Veterin- ary Medicinal Products, and having regard — intended for use in veterinary medici- to the observations formulated by the nal products for administration to members of the Committee, the Commis- food-producing animals, and sion shall prepare a draft of the measures to be taken. If the information submitted by the person responsible for marketing is insufficient to enable such a draft to be prepared, that person will be requested to — intended to be placed on the market provide the Committee with additional [author's emphasis] of one or more information for examination. The rappor- Member States which have not pre- teur shall update the evaluation report to viously authorised the use of the sub- take account of the additional information stance concerned in food-producing received. animals,

13. That provision has been amended in 16. By Council Decision 1999/879/EC of the interim — that is to say, following 17 December 1999 — adopted after delivery of the judgment of the Court of delivery of the judgment of 22 April First Instance — by Regulation (EC) 1999 — concerning the placing on the No 1308/1999. 5The new version of Regu- market and administration of bovine soma- lation No 2377/90 no longer contains any totrophin (BST) and repealing Decision requirements regarding an application for 90/218/EEC, 7 the moratorium was the establishment of a maximum residue replaced by a permanent prohibition of level of a pharmacologically active sub- BST applying with effect from 1 January stance to be used in veterinary medicinal 2000. The recitals in the preamble to that products intended for administration to animals to be used for food production. 6 — Council Decision 90/218/EEC of 25 April 1990 concerning the administration of bovine somatotrophin (BST) (OJ 1990 L 116, p. 27), as extended on several occasions, most 5 — Council Regulation (EC) No 1308/1999 of 15 June 1999 recently by Council Decision 94/936/EC of 20 December amending Regulation (EC) No 2377/90 laying down a 1994 amending Decision 90/218/EEC concerning the plac- Community procedure for the establishment of maximum ing on the market and administration of bovine somatot- residue limits of veterinary medicinal products in foodstuffs rophin (BST) (OJ 1994 L 366, p. 19). of animal origin (OJ 1999 L 156, p. 1). 7 — OJ 1999 L 331, p. 71.

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(b) to determine the points on which the 4. Each party may, at any stage of the parties must present further argument procedure, propose the adoption or modi- or which call for measures of inquiry; fication of measures of organisation of procedure. ...

(c) - (d) ... 5. ...'

3. Measures of organisation of procedure may, in particular, consist of: 21. Article 103(1):

(a) putting questions to the parties; 'Any time-limit prescribed pursuant to these Rules may be extended by whoever prescribed it.'

21 That opinion stated: '18 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 to the CVMP [Com- mittee for Veterinary Medicinal Prod- "The Committee considers that it is not ucts] for an opinion on Sometribove. necessary for the protection of public health to establish MRLs [maximum residue limits] for Sometribove, the active ingredient in the product, and it therefore recommends that Some- 19 Following the entry into force of Regu- tribove should be included in the list of lation No 2377/90, the Commission substances not subject to maximum residue limits in Annex II ..."

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23 However, at a meeting with Commis- whereas, on 20 December 1994, the sion officials on 17 October 1995, the Council adopted Decision 94/936 of applicant was informed that the Com- 20 December 1994 amending Decision mission had "removed this draft from 90/218 of 25 April 1990 concerning the agenda" because of the existence of the administration of bovine somatot- the moratorium on BST. rophin (BST);

24 In those circumstances, one of the applicant's lawyers, by letter of 6 November 1996, formally called whereas Article 1 of the decision pro- upon the Commission, pursuant to vides: 'Member States shall ensure that, Article 175 of the EC Treaty, "to take until 31 December 1999, the placing the necessary steps to refer the matter on the market of bovine somatotrophin without further delay to the [Regula- for the purposes of its marketing and tory Committee] in accordance with the administration thereof on their Regulation No 2377/90". territory to dairy cows by any means whatsoever will not be authorised', and therefore bovine somatotrophin can be neither placed on the market nor administered in the Community, since it is administered only to dairy cows; 25 Following that formal notice, the Com- mission adopted on 14 January 1997 Decision C(97) 148 final ("the con- tested decision").

whereas, since one of the conditions to be fulfilled in order to apply for 26 The fourth, fifth, sixth and seventh inclusion in the annexes to Regulation recitals in the preamble to that No 2377/90 has not been met, and the decision, and its operative part, pro- applicant has no interest in obtaining vide: such inclusion, the Commission con- siders that it is not obliged to grant the request made on 6 November 1996, although without prejudice to a reas- sessment of the situation, should cir- "whereas, under Article 6 of Regu- cumstances change; lation No 2377/90, for a new phar- macologically active substance to be capable of inclusion in one of the lists in the regulation it must be intended to be used in a veterinary medicinal product and placed on the market of one or more Member States;

25. Thereafter, on 14 April 1997, Mon- 'The Court considers that the factual and santo brought an action for annulment legal context of that case is very similar to before the Court of First Instance. The French Republic intervened in those pro- ceedings in support of the form of order 9 — Case T-120/96 Lilly Industries v Commission [1998] ECR sought by the Commission. II-2571.

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the one in which you are party ... . You are tor of Legal Services was engaged abroad in therefore invited to present any observa- international negotiations and that time tions you may have on the consequences of was needed for inter-ministerial coor- that judgment for the present Case dination with a view to analysing the T-112/97. judgment once the French version thereof was to hand.

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mission's decision. That judgment was 64 Since the Court has not found anything based inter alia on the following grounds: in fact or law which would permit a different conclusion, reference must be made to the grounds of its judgment in Lilly and the contested decision must, as a result, be annulled.' 'Arguments of the parties

61 In its letter of 6 July 1998 ... the B — The judgment in Lilly applicant observed that because of the similarity between the present case and that which gave rise to the judgment in Lilly, this case should have an identical outcome, namely the annulment of the 34. In paragraphs 82 to 94 of its judgment contested decision. in Lilly, the Court of First Instance stated as follows:

62 In its letter of 3 July 1998 ... the Commission acknowledges that the '82 The Commission has only limited dis- factual and legal context of the two cretion in examining requests for the cases is "very similar". It concedes establishment of an MRL submitted that, in the event of the Court declaring pursuant to Regulation No 2377/90. the present action admissible, the con- Except in certain specific circumstances tested decision should be annulled for (see Case T-105/96 Pharos v Commis- the same reasons that led the Court to sion [1998] ECR II-285, paragraphs 69 annul the contested decision in Lilly. and 70), the institution must apply the procedure laid down by that regulation strictly.

Findings of the Court

84 In this case, instead of drawing up a draft regulation including somidobove in Annex II and submitting it to the Adaptation Committee, the Commis- sion rejected the applicant's request on the ground that the marketing of 87 In particular, in a case such as this, somidobove was banned because of where the marketing of a product is the moratorium on BST, with the result banned under a moratorium, which is that the conditions in Article 6(1) of by definition temporary, a request by a Regulation No 2377/90 were not met. trader for the inclusion of a pharmaco- logically active substance in one of the annexes to Regulation No 2377/90 satisfies the condition laid down by the second indent of Article 6(1) of the regulation if it is clear, as it is here, that the trader concerned intends to market 85 In that connection, it should be noted the product in question once the mora- that a request made on the basis of that torium has been lifted. article must be for the inclusion of a new pharmacologically active sub- stance which is both intended for use in veterinary medicinal products foi- administration to food-producing ani- mals (Article 6(1), first indent), and intended to be placed on the market of one or more Member States which have not previously authorised the use 88 Moreover, as regards more specifically of the substance concerned in food- the reference in the contested decision producing animals (Article 6(1), second to the marketing ban imposed by the indent). moratorium on BST, it should be noted, as the Commission itself con- cedes, that the procedure for the estab- lishment of an MRL under Regulation No 2377/90 is independent of and distinct from the procedures for the issue of marketing authorisations laid 86 However, as the applicant has rightly down in Directive 81/851 and Regu- pointed out, Article 6(1) of Regulation lation No 2309/93.

hereby:]

92 Consequently, in this case, the Com- 1. Annuls Commission Decision C(97) mission was not legally entitled to base 148 final of 14 January 1997, rejecting

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the application by Monsanto Europe voted (by 73 votes) against the proposal, SA/NV for the inclusion of Sometri- four Member States voted (by 13 votes) in bove in Annex II to Council Regulation favour and one Member State abstained (4 (EEC) No 2377/90 of 26 June 1990 votes). laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin.

VII — The appeal proceedings before the Court of Justice 2. — 3. ...'

OPINION OF MR ALBER — CASE C-248/99 P

grounds of Monsanto's application, objections to the judgment in Lilly are and order the latter to pay the costs. inadmissible, alternatively unfounded.

41. In its response to the appeal, the 44. Consequently, Monsanto contends that Commission maintains that the decision the Court should: of the Court of First Instance in Lilly infringes Community law, since that court wrongly found that the Commission was bound by the opinion of the Committee for Veterinary Medicinal Products and failed to take account of the fact that the — dismiss the French Republic's appeal; establishment of a maximum residue limit and is subject to the condition that the sub- stance concerned must be intended to be placed on the market. Since the judgment in Monsanto is based on those findings, it likewise infringes Community law. — order the French Republic to pay the costs.

42. The Commission therefore claims that the Court of Justice should:

VIII— Legal assessment

— annul in its entirety the judgment of the Court of First Instance of 22 April 1999 in Case T-112/97; and A — Procedural objections

46. The French Government objects to the fact that the Court of First Instance omitted 49. At all events, none of the parties has the to mention, in the section of its judgment right under Article 50 of the Rules of dealing with the procedure, its decision not Procedure to require cases to be joined; to join the Lilly and Monsanto cases, consequently, in that regard also, the inter- despite the fact that an application to that ests of the French Republic cannot be said effect had been made by the applicants in to have been prejudiced. both those cases. It points out that it was not heard in relation to that procedural decision.

47. According to Article 51 of the EC 50. It follows that this complaint is Statute of the Court of Justice, an appeal unfounded.

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limited to supporting the submissions of the every case; it enjoys a discretion in that parties in support of whom they intervene. regard. The first sentence of Article 64(1) The Commission did not abandon its of the Rules of Procedure of the Court of application for the dismissal of the action. First Instance provides that the purpose of On the other hand, the mere fact that a measures of organisation of procedure is to party omits to put forward certain argu- ensure that cases are prepared for hearing, ments does not prevent an intervener from procedures carried out and disputes putting forward those arguments itself. 11 It resolved under the best possible conditions. is therefore necessary to examine whether Those aims also apply, mutatis mutandis, the refusal to extend the time-limit con- to decisions on the extension of time-limits. stituted a procedural irregularity prejudi- In this connection, the acceleration of the cial to the interests of the French Republic. procedure certainly constitutes a significant element.

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61. According to that case-law, the tion would not have delayed the proceed- grounds set out in an application for the ings in any way. On the contrary, it is extension of a time-limit do not in them- apparent from the further course taken by selves oblige the Court of First Instance to the proceedings, in which a hearing had grant that application. If the Director of the been fixed to take place on 16 December Legal Service was absent and inter-minis- 1998, that there was enough time to justify terial coordination was not possible within the grant to the French Republic of an the time-limit prescribed, it was in principle extension of time. Consequently, there up to the French Republic to take adequate existed no reasonable ground for refusing precautionary measures to deal with prob- the application for such an extension. lems of that kind. 15 By the same token, the absence of a French-language version of the judgment in Lilly does not appear to constitute an insuperable obstacle to the 63. It follows that there is a procedural submission of observations, 16 having irregularity in the present case.

[1984] ECR 2349, paragraph 14. The fact that requests for an extension of time were formulated by two legal the French Republic at the hearing which representatives of France in the Monsanto case shows that it would have been possible to submit at least brief took place on 16 December 1998 — an observations. opportunity of which, as it itself states, it 16 — See the judgment in Case 276/85 Cladakis v Commission [1987] ECR 495, paragraph 12. took advantage.

70. As to the arguments advanced by the French Republic, we do not know what arguments it put forward at the hearing. It 67. Monsanto concedes that, at the hear- is not possible, therefore, to judge whether, ing, France put forward arguments denying and to what extent, the Court of First that the cases of Lilly and Monsanto were Instance should have considered those comparable; however, it regards those arguments. However, it must be assumed arguments as irrelevant for the purposes that the arguments of the French Republic of determining the dispute and therefore on that point were covered in its pleadings considers that that plea is unfounded. in the present proceedings. As the following

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examination sets out to show, the question (1) The French Republic's plea concerning of the comparability of the Lilly and the comparability of the Monsanto and Monsanto cases is irrelevant for the pur- Lilly cases poses of determining the dispute. Con- sequently, the Court of First Instance was not obliged to consider it.

Arguments of the parties

B — Infringement of Community law 73. The French Republic lists a series of points intended to show that the Monsanto and Lilly cases are not comparable:

Lilly, spoke of them as being 'ex- parties involved in that case, considerations tremely similar'. Despite this, Mon- concerning the comparability of the two santo also stated at the time that the cases serve no direct purpose as regards the grounds of challenge in the two cases determination of the dispute. They can only were merely 'generally the same'. provide arguments concerning the question whether the facts of the present case should be subject to the same rules of law as those applied to the facts in Lilly and/or whether those rules are to be interpreted in the same way. 74. Further arguments put forward by France, contesting the comparability of the two cases, are directed in substance against the judgment in Lilly. They are considered elsewhere in this Opinion. 17 77. The indicators referred to above do not assist in resolving that question. For the purposes of assessing the facts or inter- preting the applicable rules, it is irrelevant whether the Court of First Instance or 75. Monsanto stresses that the joinder of Monsanto were to a greater or lesser extent two cases and the ordering of preparatory persuaded, at any given stage in the pro- inquiries — such as the putting of ques- ceedings, that the two cases are com- tions — are matters in the discretion of the parable. Court of First Instance. There was no need to repeat the questions which had been put in Lilly, apart from all else because, according to the Court of First Instance, it possessed all the information which it required and was in a position to use that 78. Moreover, those indicators, instead of information in the Monsanto case also. pointing to differences between the two cases, may equally well be seen as resulting from considerations of expediency on the part of the Court of First Instance and/or Monsanto, and cannot be objected to on that score. 18

83. The Commission submits that its pro- posal to include BST in Annex II to Regulation No 2377/90 merely follows the judgments delivered in Monsanto and Lilly. According to the Commission, the (2) The pleas put forward in the appeal press release simplifies the facts; it is proceedings by the Commission — exam- apparent from the recitals in the preamble ination of the case of Lilly to the proposal, however, that the Com- mission still had certain doubts. Moreover, the proposal has yet to be accepted. How- ever, within the Committee for the Adap- tation to Technical Progress of the Direc- 80. The Commission raises pleas directly tives on the Removal of Technical Barriers criticising the reasoning on which the Court to Trade in the Veterinary Medicinal of First instance based its judgment in Lilly. Products Sector, a clear majority of the Monsanto regards those pleas as inadmiss- Member States voted against the proposal. ible or, alternatively, unfounded. Lastly, for the purposes of gauging the admissibility of an appeal, it is exclusively the state of affairs prevailing at the date of its lodgment which is decisive. Moreover, in the context of an appeal, the Court of Justice may adjudicate only on points of law. (a) Admissibility

Arguments of the parties Assessment

81. Monsanto takes the view that this 84. First of all, it should be borne in mind argument constitutes an impermissible plea that the judgment in Lilly has binding legal directed against the judgment in Lilly. force only as between the parties to those Moreover, the Commission itself proceedings. On the other hand, the renounced its interest in bringing proceed- grounds on which the judgment in Lilly ings when it announced the inclusion of are based fall to be examined in the present BST in Annex II. case in so far as they have any bearing on

the judgment of the Court of First Instance may be prompted to doubt, on other in Monsanto and have been made the grounds, the admissibility of objections subject-matter of the appeal. raised against the reasoning of the Court of First Instance in its judgment in Lilly. It is settled case-law that an appeal must, pursuant to Article 112(1)(c) of the Rules of Procedure, 'indicate precisely which 85. As regards the Commission's proposal elements of the contested judgment it to include BST in Annex II to Regulation challenges, and also the legal arguments No 2377/90, this could conceivably dispose which specifically support the appeal'. 21 of the present case. According to The French Republic does not criticise any Article 92(2) of its Rules of Procedure, the part of the judgment in Lilly; instead, it Court of Justice may at any time decide of expressly declines to engage in any examin- its own motion that a case has become ation of that judgment. Were the Commis- devoid of purpose. sion restricted merely to supporting the pleas put forward by the French Republic, its objections to the judgment in Lilly might conceivably fall to be regarded as inadmiss- ible. 86. Whilst it is true that a party's interest in bringing proceedings ceases to exist where his opponent has in the interim acknowl- edged the validity of his assertions as to the position in law, 19 the fact that the oppo- nent — reserving his position pending the adoption of a final decision — merely complies temporarily with a decision which has not yet acquired legal force is not enough to constitute such an acknowledge- 89. However, in the present proceedings ment. 20 the Commission is not simply an inter- vener; by reason of its participation in the litigation, it is an 'other party to the proceedings'. The Court of Justice has even gone so far as to hold that a party inter- vening in proceedings must be able, when 87. Consequently, the present dispute has submitting a response to an appeal, to raise not yet been definitively determined. independent pleas relating to any point of law on which the contested judgment is based. 22 If that is the position as regards interveners in proceedings before the Court of First Instance, then it must a fortiori be 88. However, upon examining in isolation the position in relation to the defendant in the plea raised by the French Republic, one the proceedings.

(b) The entitlement of Monsanto to submit orisation, that may necessitate a twofold an application scientific examination. In addition, the fixing of a maximum residue limit must be conducive to the adoption of a decision to grant the marketing authorisation, and the former cannot take place independently 90. The parties are in dispute concerning of the latter. Consequently, the Commis- the connection between the fixing of a sion maintains, it is more coherent, from a maximum residue limit and the grant of scientific and legal standpoint, to apply authorisation to place a substance on the both sets of rules in a uniform manner. market (hereinafter 'marketing authori- However, a marketing authorisation may sation'). The connecting point is to be not be granted where it is prohibited found in the first sentence of Article 6(1) pursuant to certain particular provi- of Regulation No 2377/90, according to sions — such as those imposing the mora- which maximum residue limits are to be torium. It follows that the criteria laid fixed in respect of new substances upon the down by the first sentence of Article 6(1) of submission of an application by 'the person Regulation No 2377/90 are not fulfilled responsible for marketing', where the sub- where, on account of rules such as those stance is 'intended for use in veterinary providing for the moratorium, it is not medicinal products for administration to legally possible to market the substance. food-producing animals' and 'intended to be placed on the market of one or more Member States which have not previously authorised the use of the substance con- cerned in food-producing animals'. 92. The French Government considers that Regulation No 2377/90 must be applied within the general framework of the rules governing veterinary medicinal products. In that connection, reasonable regard must be had, in particular, to the precautionary principle, which has been recognised by the Arguments of the parties Court of Justice. 23

95. The Commission has stated that there is no control in respect of residues of BST in milk or milk products, and that the estab- Assessment lishment of a maximum residue limit is therefore of no relevance in the case of imports of such products. 98. In its judgment in Lilly, the Court of First Instance held, first, that the intention to place a substance on the market is sufficient to found an entitlement to submit an application pursuant to the first sentence of Article 6(1) of Regulation No 2377/90 96. France gives a detailed account of the and, second, that the establishment of rules of Community law concerning guide- maximum residue limits is totally indepen- lines and inspections in respect of milk and dent of, and distinct from, the procedure milk products coming from third countries. for the grant of a marketing authorisation. After referring to the exportation of BST It ruled that only the procedures for the permitted by Council Decision 1999/879/EC, grant of marketing authorisation provide France has concluded that the establish- for a refusal of such authorisation on the ment of a maximum residue limit is irrel- basis of rules such as those ordering the evant as regards imports, inasmuch as the moratorium. 26

2 4 — J u d g m e n t in Case T-125/96 Boehringer v Council and 25 — Published in OJ 1994 L 336, p. 40. Commission [ 1999] ECR II-3427, paragraph 194. 26 — Reproduced in point 5 et seq. above.

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100. The Court of Justice has repeatedly held that the legality of a contested measure must be assessed on the basis of the elements of fact and of law existing at the time when the measure was adopted. 27 102. However, according to Directive Consequently, neither the decision concern- 81/851 and Regulation No 2309/93, vet- ing the prohibition of BST for an unlimited erinary medicinal products may only be period nor the amendment of Regulation placed on the market if an authorisation No 2377/90 by Regulation No 1308/1999 — has been issued. Consequently, it is scarcely both of which were published after the conceivable that a substance should be judgment of the Court of First Instance had intended to be placed on the market where been delivered — can be taken into no marketing authorisation may be granted account for the purposes of assessing in respect of that substance. It was precisely Monsanto's entitlement to submit an appli- that refusal of a marketing authorisation cation at the time of adoption of the which was brought about by the moratoria Commission's decision. However, it is in respect of BST. necessary to examine whether the tempor- ary moratoria provisionally ordered by the Council prior to the adoption of the Com- mission's decision preclude the right to submit an application. 103. Support for such an interlinking of the right to submit an application pursuant to 27 — See the judgments in Joined Cases 15/76 and 16/76 France v Commission [1979] ECR 321, paragraph 7, and in Case Regulation No 2377/90 and the possible 114/83 Société d'Initiatives et de Coopération Agricoles and Another v Commission [1984] ECR 2589, paragraph grant of a marketing authorisation is to be 22. See also the judgment of the Court of First Instance in Case T-251/97 T. Port v Commission [2000] ECR II-1775, found not only in the wording of the first paragraph 38. sentence of Article 6(1) of Regulation

106. Only the objectives of Regulation No 2377/90 appear to militate against such 104. By contrast, the conclusion drawn a restriction on the right to submit an from Article 15 of Regulation No 2377/90 application. The recitals in the preamble by the Court of First Instance in its judg- show that the establishment of limits is ment in Boehringer is not compelling. That intended to promote public health, the provision merely states that that regulation marketing of foodstuffs of animal origin does not affect certain measures taken by and the cross-border movement of such the Community and by the Member States; foodstuffs. None of those objectives it does not state that those measures do not imperatively requires such a substance to affect the application of the regulation. be placed on the market within the Com- munity. Corresponding residues may also be contained in imported foodstuffs. It therefore appears logical, for the purposes of guaranteeing a uniform level of health protection in the internal market, to confer a right to submit applications also on 105. By the same token, the genesis of the persons wishing to place veterinary medici- first sentence of Article 6(1) of Regulation nal products on the market in countries No 2377/90 tends rather to indicate that an from which foodstuffs are imported into application may not be submitted where no the Community. marketing authorisation can be granted in respect of the substance. The corresponding Article 7(1) of the Commission's proposal merely provided that the person responsible for marketing is to apply for the establish- ment of a tolerance.28 Neither the Parlia- 107. However, it is apparent from ment or the Economic and Social Com- Article 15 of Regulation No 2377/90, mittee addressed that point of the proposal. referred to above, that, in any event, the Similarly, the published amendment to the inclusion of substances in Annex II to that Commission's proposal is silent in that regulation, as sought in the present case, regard. 29 It was not until the stage of the offers only limited legal certainty, since the final deliberations that the additional con- regulation does not totally preclude meas- dition for the submission of applications ures taken by the Member States. was inserted, requiring that the substance must be intended to be placed on the market of one or more Member States. Consequently, that restriction on the right

110. The interpretation of the first sentence 113. Particular weight attaches to Decision of Article 6(1) of Regulation No 2377/90 is 94/936. 34 That decision extended the moratorium by a period of over five years, whereas all the previous decisions had 30 — Council Directive 92/46/EEC of 16 June 1992 laying down provided for extensions lasting merely a the health rules for the production and placing on the market of raw milk, heat-treated milk and milk-based products (OJ 1992 L 268, p. 1). few months, and in no case more than two 31 — See in that regard the judgment in Case C-106/97 DADI and Douane-Agenten [1999] ECR 1-5983, paragraph 30 et seq. 32 — Council Directive 96/23/EC of 29 April 1996 on measures 33 — Council Decision 92/98/EEC of 10 February 1992 amend- to monitor certain substances and residues thereof in live ing Decision 90/218/EEC concerning the placing on the animals and animal products and repealing Directives market and administration of Bovine Somatotrophin (BST) 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC (OJ 1992 L 39, p. 41). and 91/664/EEC (OJ 1996 L 125, p. 10). 34 — Cited in footnote 6.

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years. Consequently, whilst it was legit- (iv) Conclusion imate to assume, at the beginning of the moratoria, that they would cause only a temporary obstacle to the grant of market- ing authorisations, one could no longer expect, following the repeated extensions 115. Consequently, the Commission was and in particular the last extension occur- entitled to reject Monsanto's application on ring in 1994, that a marketing authori- the ground that the latter was not entitled sation would soon be granted. to submit an application. In that regard, the Court of First Instance misapplied Com- munity law. Its judgment should accord- ingly be set aside.

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Article 6(3) of Regulation No 2377/90 tection necessitates the weighing-up of merely requires the Commission, having scientific opinions together with other regard to the observations formulated by factors, such as scientific uncertainty, the the members of that committee, to prepare concerns of consumers, ethical consider- a draft of the measures to be taken. It ations and the precautionary principle. This argues that the content of those measures is has been recognised by the Court of not prescribed in the regulation and that, Justice. 35 according to the ordinary meaning of the wording in question, the term 'having regard to' cannot be equated to an obli- gation to adopt a position. Moreover, the provision clearly confers on the Commis- sion the power to exercise its discretion in 121. France maintains that Decision the event that diverging views are expressed 1999/879 36 was adopted in order to pro- by the members of the committee. tect public, human and animal health. The Parliament's report on that measure expressly emphasises the protection of health and of consumers.

118. Article 6(3) of Regulation No 2377/90 merely requires the Commission to prepare a draft; it does not specify what the contents of that draft should be. The 122. According to the French Republic, it is procedure to be followed in accordance apparent from the judgment in Pharos 37 with that regulation is precisely specified that the Commission enjoys a discretion in only as regards the time-limits to be relation to proposals put forward in the observed; it does not relate to the decision context of comitology procedures. to be taken by the Commission.

127. Moreover, in its judgment in Boehr- 124. Monsanto considers that, for that inger, 42 the Court of First Instance reason, regard should be had only to expressly confirmed the judgment in Lilly scientific considerations and that, con- and held that it was not open to the sequently, it was not open to the Commis- institutions to implement a prohibition on sion to depart, on account of other con- the placing of certain substances on the siderations, from the opinion of the scien- market on the ground of having refused to tific committee. establish limits pursuant to Regulation No 2377/90.

125. Monsanto refers in particular to the Opinion of Advocate General Mischo in 128. Monsanto maintains that this is not Pharos, 40 which expressly concurs with the contradicted by the other legal acts cited by findings of the Court of First Instance in the Commission; on the contrary, those Lilly. acts provide for similarly regulated pro- cedures in which the Commission's discre- tion is subject to constraints.

126. According to Monsanto, it is not until the second stage of the authorisation pro- cedure under Regulation No 2377/90 — following the delivery of a possibly 129. By contrast, the unilateral rejection of negative opinion by the Committee for the an application is, according to Monsanto, Adaptation to Technical Progress of the contrary to Regulation No 2377/90. Directives on the Removal of Technical

38 — Monsanto refers to the English-language version, which reads 'the Commission shall prepare' and 'the Commission shall submit'. 39 — English-language version of the sixth recital in the 130. Furthermore, the Commission is preamble, to which the French version corresponds. The wrongly seeking to create the impression German version reads: 'Daher muss ein Verfahren fur die gemeinschaftliche Festsetzung von Hochstmengen fur Tie- rarzncimittelruckstande geschaffen werden, das einheitlich die bestmögliche Unbedenkhchkeitsprütung heinhaltet.' 4 0 — O p i n i o n of 20 May 1999 i n Case C-151/98 P, [1999] 41 — Cited in footnote 37, paragraph 31 et seq. ECR 1-8157, point 69. 42 — Cited in footnote 24.

131. The question to be examined is 133. In contrast to that precise definition of whether, following receipt of the opinion the temporal framework — which has, of the Committee for Veterinary Medicinal however, already been relaxed by the Court Products, the Commission continues to of Justice in its judgment in Pharos as enjoy any discretion of its own permitting regards the stage at which the matter is to it to depart from the opinion expressed by be referred to the Committee for the that committee. If so, the further question Adaptation to Technical Progress of the arises as to the grounds on which the Directives on the Removal of Technical Commission may found such a decision. Barriers to Trade in the Veterinary Medici- nal Products Sector —, 45 Articles 6 and 8 of Regulation No 2377/90, in the version thereof applicable in the present case, contained scarcely any particulars as to 132. Article 6 of Regulation No 2377/90, the content of the measures proposed. The in the version applicable in the present case, only rule prescribed in that regard was namely that which remained in force until contained in the first sentence of 1999, laid down a strict temporal frame- Article 6(3), according to which the draft work in relation to the procedure for the was to be prepared 'having regard to the inclusion of a new pharmacologically observations formulated by the members of active substance in Annex I, II or III to that regulation. 43 The Commission was required, within 30 days after carrying out 44 — The hitherto unamended second sentence of Article 8(2) of a purely formal verification of the appli- Regulation No 2377/90 confers on that second commit- tee — a body composed of specialist officials designated cation, to submit it to the Committee for by, and bound by instructions from, the Member States — freedom itself to set the time-limit for delivery of its Veterinary Medicinal Products, and within opinion. Thereafter, depending on the view expressed in that opinion, the Commission is required either to adopt the measure in question or to refer the matter to the Council, which likewise has three months in which to reach its decision, in the absence of which the Commission 43 — See point 12 above. The version of Regulation No 2377/90 may in turn adopt the measure. resulting from the amendment made by Regulation No 1308/1999 no longer contains the time-limits pre- 45 — Cited in footnote 37; see in particular paragraphs 18 et viously binding on the Commission. seq. and 31 et seq.

136. Accordingly, the objective pursued by the establishment of maximum limits is 134. The fact that the Commission is solely the protection of public health. It bound, albeit in the relaxed manner follows that the Commission, when adopt- described, by the opinion of the scientific ing a decision which diverges from the committee is also apparent from certain opinion of the Committee for Veterinary basic considerations concerning the demo- Medicinal Products, may not base that cratic legitimation of the Commission and decision just on any objectives of its own of the scientific committee. Whilst the choosing, but solely on the protection of exercise of sovereign powers by the Com- public health. mission is legitimised in accordance with Article 155 of the EC Treaty (now Article 211 EC) and by the political control exercised by the European Parliament, the members of the Committee for Veterinary 137. It should further be noted, for the Medicinal Products are able to invoke only purposes of determining the scope of the a technical legitimation. That, on its own, Commission's discretion, that the recitals in is not enough to justify the exercise of the preamble also specify the method to be sovereign powers. followed in ascertaining the level to be established. This requires a risk assessment to be carried out in a manner which accords with generally recognised prin- ciples and is also uniform and of the 135. This does not mean, however, that, in highest possible quality. Consequently, it the context of the decision on its draft is not open to the Commission to depart at proposals pursuant to Article 6(4) and (5) will from the risk-assessment procedure of Regulation No 2377/90, the Commis- followed by the Committee for Veterinary sion enjoys a wide discretion. The recitals Medicinal Products; instead, it is required in the preamble to the regulation indicate in principle to raise, in the course of that the grounds on which the Commission may procedure, any reservations which it may base its decision and the procedure which it have, so that the committee can for its part must follow in that regard. The third recital take those reservations into account in its states that, 'in order to protect public opinion. Only if the committee does not health, maximum residue limits must be refute the Commission's reservations con- established in accordance with generally cerning public-health protection but never- recognised principles of safety assess- theless arrives at a different result is it ment ...'. According to the sixth recital, 'it permissible for the Commission to diverge is therefore necessary to lay down a pro- from the committee's opinion.

143. Under Article 122 of its Rules of Procedure, the Court of Justice is to make a decision as to costs where the appeal is 140. It follows that if, contrary to the view well founded and the Court of Justice itself expressed in this Opinion, the Court of gives final judgment in the case. Justice were to conclude that Monsanto was entitled to submit an application in the procedure under Article 6 of Regulation No 2377/90, the judgment of the Court of First Instance in the present dispute should not be set aside. 144. Under Article 69(2) of the Rules of Procedure, which is applicable, pursuant to Article 118, to appeal proceedings, the applicant, if unsuccessful, is to be ordered to pay the costs — that is to say, the costs of the proceedings at first instance and of the appeal — if they have been applied for C — Adjudication on the appeal in the successful party's pleadings. The Commission and France have applied for a costs order. Consequently, Monsanto, as the unsuccessful party, should be ordered 141. However, the solution advocated in not only to bear its own costs but also to this Opinion is such that the judgment of pay all the costs of the Commission and the the Court of First Instance should be set costs of the French Republic as appellant in aside. the present proceedings.

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145. However, under the first sentence of their own costs. Consequently, the French Article 69(4) of the Rules of Procedure, the Republic must bear its own costs in the Member States and institutions which proceedings before the Court of First intervene in the proceedings are to bear Instance.

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