4.

In support of its action under Article 169 of the EEC Treaty the Commission has submitted the following arguments: (a) The body of Community provisions laid down by the three directives is exhaustive and therefore leaves no room, other than on the conditions laid down therein, for unilateral action on the part of the Member States such as the German measures complained of. (b) In addition, the German rules impose restrictions which are contrary to the substantive and procedural rules severally laid down by the Community directives. (c) Finally, and in the alternative, the restrictions imposed by the German rules are contrary to Article 30 of the EEC Treaty and cannot be justified by reference to Article 36 thereof on the ground of the protection of animal and human health. Let us examine each of those three arguments which are all contested by the Federal Republic of Germany. (a) Exhaustive nature of the harmonized provisions of Community law The Commission does not maintain that the harmonization of national legislation concerning feedingstuffs is altogether complete. In particular, the provisions relating to pathogenic microorganisms still remain to be harmonized. However, since Directive 79/373 came into force on 1 January 1981 the substantive provisions resulting from the three directives constitute an exhaustive set of rules on the composition of compound feedingstuffs. The first two directives govern the use of substances which are really ‘problematical’ and fix content levels for those substances; they expressly exclude the introduction by the Member States of marketing restrictions other than those provided for in those directives, or at least adopted pursuant to the procedures specified therein. For its part the compound feedingstuffs directive, which is limited essentially to requirements regarding the packaging and labelling of feedingstuffs, manifests an intention on the part of the legislature to provide for the unrestricted marketing within the Community of all feedingstuffs which comply with the requirements laid down therein, leaving the manufacturer to choose the appropriate composition; in this field the directive merely prohibits the Member States from introducing any new restrictions regarding the presence or absence of ingredients and authorizes them to recommend types of compound feedingstuffs which meet certain analytical characteristics. Finally, the Commission claims, apart from authorized additives and prohibited undesirable substances, it follows from the compound feedingstuffs directive that, save as otherwise provided, the composition of such feedingstuffs is deliberately placed by the Community legislature outside the ambit of any national rules so that the contested German provision has the effect of hindering the free movement of all compositions of compound feedingstuffs. The counterpart to the manufacturer's freedom to determine the composition is the right given to the Member States on the basis of Article 3 of the directive to impose sanctions in respect of individual cases of abuse. That provision could not give the Member States general powers to adopt unilateral preventive measures without going back on the harmonization which has already been achieved. Contrary to the Commission, the Federal Republic of Germany takes the view that the three directives have not completely harmonized the rules relating to the composition of compound feedingstuffs, in particular those relating to the ‘constitutive elements’ of feedingstuffs, such as iron and sodium, which, in its opinion, cannot be regarded as additives or undesirable substances. That view is confirmed, it alleges, in particular by the wording of Directive 79/373 itself, Articles 8 and 15 of which show that in the absence of Community rules the Member States are authorized to maintain their own rules regarding ingredients. Despite the obligation contained in Article 15, the Commission has not yet proposed any amendments so that the harmonization of the rules relating to the ingredients of compound feedingstuffs is incomplete. The non-exhaustive nature of the directives from other provisions of Community law, in particular Directive 82/471 concerning bioproteins, which regulated for the first time the use of certain ingredients. In addition, the Court has held that directives are recognized as being exhaustive only if the harmonization effected by them is complete. In fact, the Federal Republic of Germany maintains, the three directives have only dealt in a fragmentary manner with the question of the composition of compound feedingstuffs. The Member States therefore retain the power to adopt any appropriate provisions, at least whenever measures are necessary for the protection of animal or human health. In that connection the defendant notes that, contrary to the other two directives, Directive 79/373 does not contain any special procedure enabling the Member State to meet such a need. To accept that the harmonization provisions are exhaustive would mean giving manufacturers a completely free hand and denying the Member States the possibility of adopting any urgent measures that may be needed in the field. That is certainly not the meaning of Article 3, the second sentence of which generally empowers the Member States to adopt any measure — that may be necessary for the protection of animal and human health against the dangers which may result from the absence or excessive concentration of certain analytical constituents, such as iron and sodium. Finally the defendant contends that the prohibition of additional marketing restrictions laid down by Article 9 of Directive 79/373 cannot limit the prerogatives of the Member States under the second sentence of Article 3 and Articles 8 and 15. (b) Applicability of the several directives In the Commission's opinion the German rules are in breach of the provisions of the additives directive and the undesirable substances directive as well as the compound feedingstuffs directives. The Commission considers that a manufacturer, who is free to choose how he will meet the minimum iron requirement will necessarily be prompted to have recourse to the iron additives referred to in Directive 70/524 rather than to choose ingredients which are rich in iron. If he used those ingredients in preference to additives he would to a considerable extent have to stop using the usual basic products with an iron content of approximately 30 mg per kg (ppm) and in particular milk powder subsidized by the Community. With regard to iron additives the directive lays down only a maximum level and prohibits all marketing restrictions other than those contained therein so that, at least indirectly, the German rules infringe those provisions and are thereby in breach of Article 5 of the EEC Treaty. Sodium must, in the Commission's view, be regarded as an undesirable substance which is covered by Directive 74/63 alone since, above a certain concentration, it involves a health risk. Since the directive does not contain any provision concerning sodium, it follows that a restriction of the type established by the German rules is prohibited. Furthermore, the Commission alleges that the provisions at issue were deliberately adopted in a manner other than by the appropriate procedures prescribed by the said two directives either to deal with a threat to animal or human health or to take account of scientific or technical developments. Finally, if the provisions in question are to be regarded, as is maintained by the defendant, as not relating to the use of iron and sodium as additives or undesirable substances but as the analytical constituents of ingredients, the Commission maintains that Article 8 of Directive 79/373 prohibits the Member States, from 2 April 1979, from adopting, as the Federal Republic of Germany has done by the Verordnung at issue, any new rules prescribing or prohibiting the use of certain ingredients. It cannot justify such unlawful conduct by alleging that the Commission had not implemented the procedure provided for in Article 15 of Directive 79/373. For its part the German Government denies that the specialized directives are applicable. In its view Directive 70/524 applies only to iron in the form of additives, that is to say iron compounds such as those listed in the annex to that directive, which are intentionally added to feedingstuffs, and does not apply to iron in the form of analytical constituents naturally present in certain ingredients. The German rules in fact leave manufacturers free to choose ingredients which are rich in iron (for example fishmeal) in order to meet the minimum iron requirement for complete feedingstuffs intended for calves. The additives directive is not therefore applicable to the German rules. The German Government argues that Directive 74/63 prohibits only substances which are undesirable regardless of their concentration in feedingstuffs. Sodium, however, is a necessary substance in an animal's diet; its presence is desirable since it is an essential element in the nutritive value of feedingstuffs. Consequently, sodium is not to be classified as an undesirable substance merely on the ground that an excessive dose could prove to be dangerous. Finally, the German Government contends that the additives directive, which relates only to substances intentionally added to feedingstuffs, and the undesirable substances directive, which relates only to substances which are naturally harmful, cannot apply to the analytical constituents or ingredients of compound feedingstuffs which are present in the natural state and which give them their nutritive value. The Commission contests the extent of the distinction drawn by the German Government, maintaining that the borderline between constituents, undesirable substances and additives is blurred so that a substance cannot necessarily straightaway be classified in one or the other of those categories. The concept of constituents applies to all substances contained in feedingstuffs. Accordingly, depending on the particular case, the same substance may be present as an undesirable substance — when the concentration is excessive — or as an additive — if it is intentionally added — or as a mere constituent having no particular property. (c) Justification for animal or human health reasons According to the Commission the exhaustive nature of the harmonization effected in the field by the three directives means that it is no longer lawfully possible, according to the settled case law of the Court, to lay down by means of a derogation under Article 36 of the EEC Treaty a marketing restriction not expressly provided for by the directives. The adaptation procedures provided for by the additives directive and the undesirable substances directive cannot be relied upon by the defendant since in this case it deliberately placed itself outside their field of application. For its part, Article 3 of Directive 79/373 merely authorizes the Member States to adopt measures against individual abuses. The Commission contends that in any case the German rules cannot be justified by the desire to ensure the protection of animal and human health. In that connection it observes that the defendant has been unable to show that any danger actually existed or even that the alleged practices existed. It points out that, in view of the average iron content of feedingstuffs in the Community, namely approximately 30 mg/kg (ppm), a small level of iron in compound feedingstuffs for calves is not necessarily dangerous for the animals. Furthermore, it is not clear what commercial interest manufacturers might have in the excessive use of sodium. Finally, the Commission points out that Directive 79/373 offers the defendant less radical means of countering the alleged risks, namely by appropriate labelling or by exercising the right to make recommendations provided for by Article 14 (a). Moreover, it recalls that when, after receiving the reasoned opinion, the Federal Republic of Germany submitted a proposal for substantive amendments to the contested rules, the Standing Committee for Feedingstuffs rejected it on grounds which were based essentially on the same analysis as that put forward by the Commission. The Federal Republic of Germany maintains that the contested rules seem more appropriate to deal with the aforementioned malpractices than the measures suggested by the Commission and points out that the latter does not dispute the dangers which the German measures sought to counter. Consequently, the German Government was justified in adopting the contested measures, either on the basis of the second sentence of Article 3 of Directive 79/373 or on the basis of the derogations provided for by Article 36 of the EEC Treaty.