(Reference for a preliminary ruling from the Verwaltungsgericht Köln)

(Reference for a preliminary ruling – Validity of Regulation (EC) No 1873/2003 – Veterinary medicinal products – Regulation (EEC) No 2377/90 – Maximum residue limits of veterinary medicinal products in foodstuffs of animal origin – Progesterone – Restrictions on use – Directive 96/22/EC)

Summary of the Judgment

Agriculture – Uniform legislation – Maximum residue limits of veterinary medicinal products in foodstuffs of animal origin – Determination procedure – Regulation No 2377/90

(Council Regulation No 2377/90, Annex II; Commission Regulation No 1873/2003; Council Directive 96/22)

Having regard both to the extent of the Commission’s discretion and to all the factual circumstances in light of which Regulation No 1873/2003 amending Annex II to Regulation No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin was adopted, it does not appear that the approach followed by the Commission, by restricting inclusion of progesterone in Annex II to that regulation to a specific method of administration, taking account both of considerations of protection of human health and of requirements based on the principle of proportionality, disregarded the limits of the Commission’s discretion.

Although it is true that Article 3 of Regulation No 2377/90 does not expressly provide for the possibility of including a substance in Annex II thereto for only some of its methods of administration, that fact cannot prevent the Commission from nevertheless making such an inclusion. That approach may appear particularly appropriate where, on the one hand, the substance in question cannot be included in Annex I or III to that regulation, but where, on the other, certain limitations on the methods of administration of that substance can make it possible to ensure that the presence of residues in animal tissue does not constitute a risk for human health, so that a total prohibition on marketing that substance following its inclusion in Annex IV to that regulation would be disproportionate.

That conclusion is in no way called into question by the provisions of Directive 96/22 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of Beta-agonists, as amended by Directive 2003/74, which allow Member States to authorise the administration of progesterone by intramuscular injection. The conditions under which Article 4 of that directive allows Member States to authorise the administration of progesterone to farm animals include that of compliance with the requirements relating to placing on the market laid down in Directive 81/851, which was repealed subsequently by Directive 2001/82 on the Community code relating to veterinary medicinal products. That provision, read in conjunction with Article 6 of Directive 2001/82, permits Member States to authorise administration of progesterone to farm animals only if that substance is included in Annex I, II or III to Regulation No 2377/90 in accordance with the provisions thereof.

(see paras 31, 34, 42-43, 45)

17 July 2008 (*)

(Reference for a preliminary ruling – Validity of Regulation (EC) No 1873/2003 – Veterinary medicinal products – Regulation (EEC) No 2377/90 – Maximum residue limits of veterinary medicinal products in foodstuffs of animal origin – Progesterone – Restrictions on use – Directive 96/22/EC)

In Case C‑448/06,

REFERENCE for a preliminary ruling under Article 234 EC from the Verwaltungsgericht Köln (Germany), made by decision of 24 October 2006, received at the Court on 2 November 2006, in the proceedings

Bundesrepublik Deutschland,

THE COURT (First Chamber),

composed of P. Jann, President of the Chamber, A. Tizzano (Rapporteur), A. Borg Barthet, M. Ilešič and E. Levits, Judges,

Advocate General: J. Mazák,

Registrar: J. Swedenborg, Administrator,

having regard to the written procedure and further to the hearing on 18 October 2007,

after considering the observations submitted on behalf of:

–cp-Pharma Handels GmbH, by R. Köhne, Rechtsanwalt,

–the Greek Government, by S. Charitaki and S. Papaioannou, acting as Agents,

–the Polish Government, by E. Ośniecka-Tamecka, acting as Agent,

–the Commission of the European Communities, by B. Stromsky and B. Schima, acting as Agents,

after hearing the Opinion of the Advocate General at the sitting on 16 January 2008,

gives the following

1This reference for a preliminary ruling concerns the validity of Commission Regulation (EC) No 1873/2003 of 24 October 2003 amending Annex II to Council 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 (OJ 2003 L 275, p. 9).

2The reference was made in the course of proceedings between cp-Pharma Handels GmbH (‘cp-Pharma’) and Bundesrepublik Deutschland (Federal Republic of Germany) with regard to a decision of the competent German authority revoking the marketing authorisation for the medicinal product ‘progesterone for veterinary use’ in the form of a solution administered by intramuscular injection which had been granted to that company.

Legal context

Community legislation

Directive 2011/92

Recitals 7 to 9 of Directive 2011/92 state:

‘(7) Development consent for public and private projects which are likely to have significant effects on the environment should be granted only after an assessment of the likely significant environmental effects of those projects has been carried out. …

(8) Projects belonging to certain types have significant effects on the environment and those projects should, as a rule, be subject to a systematic assessment.

(9) Projects of other types may not have significant effects on the environment in every case and those projects should be assessed where the Member States consider that they are likely to have significant effects on the environment.’

Article 2(1) of that directive provides:

‘Member States shall adopt all measures necessary to ensure that, before development consent is given, projects likely to have significant effects on the environment by virtue, inter alia, of their nature, size or location are made subject to a requirement for development consent and an assessment with regard to their effects on the environment. Those projects are defined in Article 4.’

Under Article 3(1) of that directive:

‘The environmental impact assessment shall identify, describe and assess in an appropriate manner, in the light of each individual case, the direct and indirect significant effects of a project on the following factors:

…

(b) biodiversity, with particular attention to species and habitats protected under [Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ 1992 L 206, p. 7), as amended by Council Directive 2013/17/EU of 13 May 2013 (OJ 2013 L 158, p. 193) (“Directive 92/43”)] and Directive 2009/147/EC [of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ 2010 L 20, p. 7)];

…’

Article 4 of Directive 2011/92 provides:

‘1. Subject to Article 2(4), projects listed in Annex I shall be made subject to an assessment in accordance with Articles 5 to 10.

(a) a case-by-case examination;

(b) thresholds or criteria set by the Member State.

Member States may decide to apply both procedures referred to in points (a) and (b).

Where a case-by-case examination is carried out or thresholds or criteria are set for the purpose of paragraph 2, the relevant selection criteria set out in Annex III shall be taken into account. Member States may set thresholds or criteria to determine when projects need not undergo either the determination under paragraphs 4 and 5 or an environmental impact assessment, and/or thresholds or criteria to determine when projects shall in any case be made subject to an environmental impact assessment without undergoing a determination set out under paragraphs 4 and 5.

Where Member States decide to require a determination for projects listed in Annex II, the developer shall provide information on the characteristics of the project and its likely significant effects on the environment. The detailed list of information to be provided is specified in Annex IIA. The developer shall take into account, where relevant, the available results of other relevant assessments of the effects on the environment carried out pursuant to Union legislation other than this Directive. The developer may also provide a description of any features of the project and/or measures envisaged to avoid or prevent what might otherwise have been significant adverse effects on the environment.

The competent authority shall make its determination, on the basis of the information provided by the developer in accordance with paragraph 4 taking into account, where relevant, the results of preliminary verifications or assessments of the effects on the environment carried out pursuant to Union legislation other than this Directive. The determination shall made available to the public and:

(a) where it is decided that an environmental impact assessment is required, state the main reasons for requiring such assessment with reference to the relevant criteria listed in Annex III; or

(b) where it is decided that an environmental impact assessment is not required, state the main reasons for not requiring such assessment with reference to the relevant criteria listed in Annex III, and, where proposed by the developer, state any features of the project and/or measures envisaged to avoid or prevent what might otherwise have been significant adverse effects on the environment.

Member States shall ensure that the competent authority makes its determination as soon as possible and within a period of time not exceeding 90 days from the date on which the developer has submitted all the information required pursuant to paragraph 4. In exceptional cases, for instance relating to the nature, complexity, location or size of the project, the competent authority may extend that deadline to make its determination; in that event, the competent authority shall inform the developer in writing of the reasons justifying the extension and of the date when its determination is expected.’

Annex II.A of that directive contains the list of ‘information to be provided by the developer on the projects listed in Annex II’. That list reads as follows:

‘1. A description of the project, including in particular:

(a) a description of the physical characteristics of the whole project and, where relevant, of demolition works;

(b) a description of the location of the project, with particular regard to the environmental sensitivity of geographical areas likely to be affected.

(a) the expected residues and emissions and the production of waste, where relevant;

(b) the use of natural resources, in particular soil, land, water and biodiversity.

Annex III to that directive sets out the ‘criteria to determine whether the projects listed in Annex II should be subject to an environmental impact assessment’.

Directive 2014/52

Recitals 11 and 29 of Directive 2014/52 state:

‘(11) The measures taken to avoid, prevent, reduce and, if possible, offset significant adverse effects on the environment, in particular on species and habitats protected under [Directive 92/43] and Directive 2009/147 …, should contribute to avoiding any deterioration in the quality of the environment and any net loss of biodiversity, in accordance with the [European] Union’s commitments in the context of the [United Nations Convention on Biological Diversity, signed in Rio de Janeiro on 5 June 1992,] and the objectives and actions of the Union Biodiversity Strategy up to 2020 laid down in the [Communication from the Commission to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions] of 3 May 2011 entitled ‘Our life insurance, our natural capital: an EU biodiversity strategy to 2020’ [(COM(2011) 244 final)]’

…

(29) When determining whether significant effects on the environment are likely to be caused by a project, the competent authorities should identify the most relevant criteria to be considered and should take into account information that could be available following other assessments required by Union legislation in order to apply the screening procedure effectively and transparently. In this regard, it is appropriate to specify the content of the screening determination, in particular where no environmental impact assessment is required. Moreover, taking into account unsolicited comments that might have been received from other sources, such as members of the public or public authorities, even though no formal consultation is required at the screening stage, constitutes good administrative practice.’

Directive 92/43

Article 6(3) of Directive 92/43 provides:

‘Any plan or project not directly connected with or necessary to the management of the site but likely to have a significant effect thereon, either individually or in combination with other plans or projects, shall be subject to appropriate assessment of its implications for the site in view of the site’s conservation objectives. In the light of the conclusions of the assessment of the implications for the site and subject to the provisions of paragraph 4, the competent national authorities shall agree to the plan or project only after having ascertained that it will not adversely affect the integrity of the site concerned and, if appropriate, after having obtained the opinion of the general public.’

Article 12(1) of that directive provides:

‘Member States shall take the requisite measures to establish a system of strict protection for the animal species listed in Annex IV(a) in their natural range, prohibiting:

(a) all forms of deliberate capture or killing of specimens of these species in the wild;

(b) deliberate disturbance of these species, particularly during the period of breeding, rearing, hibernation and migration;

(c) deliberate destruction or taking of eggs from the wild;

(d) deterioration or destruction of breeding sites or resting places.’

Point (a) of Annex IV to that directive mentions ‘all species’ of bats belonging to the suborder of ‘microchiroptera’.

Irish law

(10) The Commission considers that safeguards as to the possibility of misuse of veterinary medicinal products containing progesterone are necessary. Restricting the terms of the use of progesterone to administration only via the intravaginal route in female animals of bovine, ovine, caprine and equine species provides this additional safeguard needed to avoid misuse as the relevant veterinary medicinal products cannot, due to their specific presentation, be realistically used for prohibited purposes. It is therefore considered appropriate to include progesterone in Annex II to Regulation … No 2377/90 in accordance with the Annex to the present proposal for a Commission Regulation, which limits the use of progesterone to this specific purpose and product formulation.

The other relevant provisions

– Directive 96/22

13Directive 96/22, as amended by Directive 2003/74/EC of the European Parliament and of the Council of 22 September 2003 (OJ 2003 L 262, p. 17; ‘Directive 96/22’), which is the version relevant to the dispute in the main proceedings, provides that Member States are to prohibit the administration to a farm animal of hormonal substances having a gestagenic effect, which includes progesterone.

14By derogation and in a limited number of cases, Article 4(1) of Directive 96/22 states that Member States may authorise ‘the administering to farm animals, for therapeutic purposes, of …, testosterone and progesterone … Veterinary medicinal products used for therapeutic treatment must comply with the requirements for placing on the market laid down in [Council] Directive 81/851/EEC [of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (OJ 1981 L 317, p. 1)] and be administered only by a veterinarian, by injection or for the treatment of ovarian dysfunction in the form of vaginal spirals, but not by implant, to farm animals which have been clearly identified. …’.

– Directive 2001/82/EC

15Article 6 of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ 2001 L 311, p. 1) provides:

‘In order that a veterinary medicinal product may be the subject of a marketing authorisation for the purpose of administering it to food-producing animals, the active substances which it contains must be shown in Annex I, II or III of Regulation … No 2377/90.’

16Article 96 of Directive 2001/82 provides:

‘[Directives] 81/851/EEC, 81/852/EEC, 90/677/EEC and 92/74/EEC … are repealed …’

The reference made to the said Repealed Directives shall be construed as references to this Directive …’

National legislation

17The first sentence of Paragraph 30(1) of the German Law on medicinal products (Arzneimittelgesetz), in the version published on 11 December 1998 (BGBl. 1998 I, p. 3586; ‘the AMG’), provides:

‘An authorisation … must be revoked where one of the grounds for refusal under Paragraph 25(2)(3),(5),(5a), (6) or (7) subsequently arises.’

18Paragraph 25(2)(7) of the AMG provides:

‘The competent higher federal authority may refuse to grant an authorisation only if

…

The dispute in the main proceedings and the question referred for a preliminary ruling

19On 16 February 1999, cp-Pharma obtained an extension of the marketing authorisation for the veterinary medicinal product ‘progesterone ad us. vet’ for a period of five years. That authorisation concerned a solution for intramuscular injection, the active substance of which is progesterone, to be administered in cases of follicle cysts and ‘nymphomania caused by follicle cysts’.

20By decision of 22 January 2004, the competent authority revoked the marketing authorisation on the ground that progesterone was listed in Annex II to Regulation No 2377/90 for administration only via the intravaginal route. According to that authority, since no MRL has been established for other applications, the prohibition set out in Article 14 of that regulation applied to that medicinal product and therefore the authorisation had to be revoked.

21Following the rejection of its objection to that decision to revoke the authorisation, cp-Pharma brought an action before the referring court seeking annulment of that decision on the ground that the Commission had disregarded the recommendation of the CVMP, which asked it to include progesterone in Annex II to Regulation No 2377/90 without limiting its use to intravaginal administration.

22In the decision for reference, the Verwaltungsgericht Köln (Administrative Court, Cologne) takes the view that Regulation No 2377/90, in the event of the listing of a substance in Annex II thereto, does not empower the Commission to impose restrictions as to the methods of administration of that substance. Moreover, such a possibility appears, mutatis mutandis, to have been excluded by the Court in Case C‑32/00 P Commission v Boehringer [2002] ECR I‑1917, paragraph 55, in which it held that, where the substance in question is entered in Annex III to that regulation, the only limitation on the validity of an MRL envisaged by that regulation concerns the indication of the limited duration of its validity.

23The referring court observes, in addition, that the CVMP had proposed that progesterone be entered in Annex II to Regulation No 2377/90 without any restrictions, as the risks to health through progesterone residues were estimated to be minimal.

24Finally, that court notes that the provisions of Directive 96/22, establishing measures to avoid any misuse in the administration of progesterone as a veterinary medicinal product, provide expressly that that substance may be administered by injection.

Having regard to the foregoing, the Verwaltungsgericht Köln decided to stay the proceedings and to refer the following question to the Court for a preliminary ruling:

‘Is … Regulation … No 1873/2003 … partially void on account of a breach of higher-ranking Community law (Articles 1(1) and 3 of … Regulation … No 2377/90 in conjunction with Article 4(1) of … Directive 96/22 …), in so far as application of an injection solution as a pharmaceutical form is excluded by virtue of the note marked (*) against the listing of progesterone in Annex II to … Regulation … No 2377/90?’

The question referred

26Cp-Pharma and the Polish Government take the view, contrary to that of the Greek Government and the Commission, that Regulation No 1873/2003 is invalid in that Regulation No 2377/90 does not expressly authorise the Commission to establish an MRL solely for certain methods of administration of progesterone and Directive 96/22 permits Member States to authorise marketing of that substance in injectable form. Cp-Pharma adds that, in any event, the Commission could not adopt a measure concerning the MRL for progesterone which contradicts the opinion of the CVMP, while the Polish Government submits that Regulation No 1873/2003 is insufficiently reasoned with regard to the grounds on which the Commission decided not to follow that opinion.

27In order to answer the question referred by the national court, it is appropriate to note that, as the Court has already held in paragraph 80 of the judgment in Case C‑198/03 P Commission v CEVA and Pfizer [2005] ECR I‑6357, the Commission must be given a discretion which is sufficient to allow it to determine, on a fully informed basis, the measures that are necessary and appropriate for the protection of public health.

28That is evidently all the more justified with regard to a file such as that concerning progesterone which, as the Court has already recognised, is particularly complex since it raises questions which are delicate and controversial from a scientific viewpoint (Commission v CEVA and Pfizer, paragraph 81).

29That complexity is due to the fact that progesterone, in addition to therapeutic treatment, is liable to be used unlawfully as a growth stimulate and, currently, there are no reliable methods of analysis permitting distinction between endogenous progesterone, produced naturally by the animals, and exogenous progesterone, resulting from the administration of medicinal products, and therefore monitoring of the abusive use of that substance. Furthermore, the Commission, when it adopted Regulation No 1873/2003, was faced with a situation of ongoing scientific uncertainty with regard to the possible harmful effects of progesterone, characterised by divergent scientific opinions adopted by the CVMP, on the one hand, and by the SCVPH and other international scientific bodies, on the other (see, to that effect, Commission v CEVA and Pfizer, paragraph 82).

30In such circumstances, it is necessary to ascertain whether the Commission has exceeded the limits of its discretion by providing for the inclusion of progesterone in Annex II to Regulation No 2377/90 only in respect of its intravaginal use.

31Although it is true that Article 3 of Regulation No 2377/90 does not expressly provide for the possibility of including a substance in Annex II thereto for only some of its methods of administration, that fact cannot, as the Advocate General observed in point 52 of his Opinion, prevent the Commission from nevertheless making such an inclusion. That approach may appear particularly appropriate where, as in the dispute in the main proceedings, the substance in question cannot be included in Annex I or III to that regulation, but where certain limitations on the methods of administration of that substance can make it possible to ensure that the presence of residues in animal tissue does not constitute a risk for human health, so that a total prohibition on marketing that substance following its inclusion in Annex IV to that regulation would be disproportionate.

32As is apparent from the sixth and eighth recitals in the preamble to Regulation No 1873/2003, the fact that endogenous progesterone cannot be distinguished from exogenous progesterone made it impossible to establish an MRL, for the purposes of inclusion of that substance in Annex I or III to Regulation No 2377/90, which would exclude the existence of a risk to consumer health.

33However, as the Commission has stated in its observations submitted to the Court and in its answers to the written questions put by the Court, without being contradicted on that point by the applicant in the main proceedings or by the governments which submitted observations to the Court, the inclusion of progesterone in Annex II to Regulation No 2377/90 exclusively in respect of intravaginal administration is likely to exclude risks to human health. As is apparent from those observations, in the case of administration by intravaginal spiral, the concentration of progesterone in the body of the animal increases significantly, then falls rapidly without leaving significant residues when the spiral is removed, whereas administration by injection leaves long-lasting residues potentially dangerous to human health.

34In those circumstances, having regard both to the extent of the Commission’s discretion and to all the factual circumstances in light of which Regulation No 1873/2003 was adopted, it does not appear that the approach followed by the Commission, taking account both of considerations of protection of human health and of requirements based on the principle of proportionality, disregarded the limits of the Commission’s discretion.

35Contrary to cp-Pharma’s submissions, the fact that the CVMP had recommended the inclusion of progesterone in Annex II to Regulation No 2377/90 without any restriction as to its method of administration is not such as to call that conclusion into question.

36In that regard, it is sufficient to note, firstly, that there is no provision of Regulation No 2377/90 which lays down that the opinions of the CVMP are binding and, secondly, that it follows expressly from the third recital in the preamble to that regulation that, in the course of establishing MRLs, the Commission must take account of any scientific assessment of the safety of the substances concerned which may have been undertaken by international organisations, in particular the Codex Alimentarius, or by other scientific committees established within the Community.

37In other words, in the course of exercising its discretion, the Commission was in no way required to take account only of the opinion of the CVMP, which favoured inclusion of progesterone in Annex II to that regulation, but could legitimately base its decision on other information and scientific assessments, including the opinions of the SCVPH, which had pointed out the risks to human health resulting from the presence of residues of that substance in foodstuffs of animal origin.

38Nor did the Commission, contrary to the submissions of the Polish Government, infringe the obligation to give reasons by not specifically mentioning the scientific data which led it not to follow the opinion of the CVMP and by not indicating the extent to which the data contradicted that opinion.

39It must be pointed out that the sixth recital in the preamble to Regulation No 1873/2003 refers expressly to the opinions of the SCVPH, differing from those of the CVMP, which had confirmed on several occasions both the risks arising from use of progesterone and the fact that it is impossible to establish MRLs for that substance. Furthermore, the eighth and tenth recitals in the preamble to that regulation state the reasons for which, according to the Commission, only intravaginal administration of progesterone can prevent the misuse of that substance.

Therefore, in accordance with the requirements of established case-law (see, inter alia, Case C‑367/95 P Commission v Sytraval and Brink’s France [1998] ECR I‑1719, paragraph 63; Joined Cases C‑346/03 and C‑529/03 Atzeni and Others [2006] ECR I‑1875, paragraph 73; and Case C‑266/05 P Sison v Council [2007] ECR I‑1233, paragraph 80), the reasoning given for Regulation No 1873/2003 shows in a clear and unequivocal fashion the reasoning followed by the Commission in such a way as to enable the persons concerned to ascertain the reasons for the measure and to enable the Court to exercise its power of review.

41With regard to the argument raised by the Polish Government that Regulation No 1873/2003 infringes the principle of proportionality because it is based on a purely hypothetical risk to human health which is not supported by the scientific data set out in its reasoning, it suffices to note that, as has been recalled in paragraph 39 of the present judgment, the existence of such a risk, confirmed by a number of scientific opinions, is clearly apparent from the reasoning of that regulation.

42It should also be noted that the conclusion, set out in paragraphs 31 and 34 of the present judgment, that the Commission may restrict the inclusion of the substance in Annex II to Regulation No 2377/90 according to its method of administration is in no way called into question by the argument of the Polish Government that Regulation No 1873/2003 is incompatible with the provisions of Directive 96/22 which permit the administration of progesterone by intramuscular injection.

43Firstly, it is appropriate to note that the conditions under which Article 4 of Directive 96/22 allows Member States to authorise the administration of progesterone to farm animals include that of compliance with the requirements relating to placing on the market laid down in Directive 81/851, which was repealed subsequently by Directive 2001/82.

44Secondly, Article 6 of Directive 2001/82 expressly provides that, in order for a veterinary medicinal product to receive marketing authorisation for administration to food-producing animals, the active substances which that medicinal product contains must appear in Annex I, II or III to Regulation No 2377/90.

45Accordingly, it is clear that Article 4 of Directive 96/22, read in conjunction with Article 6 of Directive 2001/82, permits Member States to authorise administration of progesterone to farm animals only if that substance is included in Annex I, II or III to Regulation No 2377/90 in accordance with the provisions thereof.

46On the grounds set out in paragraphs 31 to 33 of the present judgment, the Commission could legitimately restrict the inclusion of progesterone in Annex II to that regulation to a specific method of administration, that is to say intravaginally. In those circumstances, there is no incompatibility between the provisions of Regulation No 2377/90 and those of Article 4 of Directive 96/22.

47Having regard to all of the foregoing, the answer for the referring court must be that examination of the question referred has disclosed no factor of such a kind as to affect the validity of Regulation No 1873/2003.

Costs

48Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.

On those grounds, the Court (First Chamber) hereby rules:

Examination of the question referred has disclosed no factor of such a kind as to affect the validity of Commission Regulation (EC) No 1873/2003 of 24 October 2003 amending Annex II to Council 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.

[Signatures]

*

Language of the case: German.