A — 

By this action, brought under Article 169 of the EEC Treaty, the Commission seeks a declaration that the Italian Republic has failed to fulfil its obligations under Article 30 of the EEC Treaty. It is charged with restricting the importation of foodstuffs which contain animal gelatin and which are lawfully manufactured and marketed in another Member State.

The contested Decreto Ministeriale [Ministerial Order] was adopted by the Italian Ministry of Health on 20 October 1978 (General supplement to the Gazzetta Ufficiale [Official Gazette] No 337 of 2. 12. 1978). It concerns permissible chemical additives in the manufacture and conservation of foodstuffs and provides that some foodstuffs may be manufactured and marketed in Italy only if their animal gelatin content does not exceed a certain percentage. In respect of preserved meat products (carni cotte) the maximum percentage laid down is 0.4% and in respect of ice-cream (gelati) and confectionery products (prodotti dolciari) it is 1%.

In the Commission's view, that order constitutes a prohibited measure having an effect equivalent to a quantitative restriction on imports within the meaning of Article 30 since it is not necessary on the grounds of consumer protection and is not justified on the grounds of public health. It therefore followed the preliminary procedure provided for by the first paragraph of Article 169 of the EEC Treaty, for the details of which I refer the Court to the Report for the Hearing. Referring to previous correspondence relating to restrictions on imports into Italy of jellied sweets, it objected in its letter of complaint primarily to the restriction which the contested order imposed on the gelatin content of confectionery products. In its reasoned opinion of 24 November 1982 it objected expressly to the whole of that order and required the Italian Republic to remove that obstacle to trade within two months.

During the preliminary procedure the Italian Government took the view that until the field in question had been definitively harmonized the Member States were not prevented from laying down the maximum proportion of gelatin additive; however, in its reply to the reasoned opinion it expressed its willingness to increase the maximum percentage in the case of jellied sweets. Thereupon the Commission brought an action for the aforementioned declaration on 29 March 1983. Only after the application had been lodged did the Italian Republic adopt the Decreto Ministeriale of 14 April 1983 (Gazzetta Ufficiale No 120 of 4. 5. 1983) in order to terminate the contested restriction on the use of animal gelatin in sweets and permit it to be added in accordance with “normal manufacturing processes”(secondo buona tecnica industriale).

The Italian Government contends that the Court should declare that it has removed the restriction on the use of animal gelatin in sweets and for the rest should dismiss the application.

B — 

My views on those claims are as follows :

(a)

The application is only admissible if the preliminary procedure has been properly followed. The purpose of that procedure is to give the Member States an opportunity to defend or alter their position in order to avoid legal proceedings. Consequently, according to a series of previous judgments of the Court, the subject-matter of the action and the subject-matter of the preliminary procedure must be the same. The mandatory requirement that the Member State concerned must be given an opportunity to submit its observations is satisfied only if the Member State is informed at the initial stage of the essence of all factual and legal complaints against it.

In this case the Commission referred expressly in its letter of complaint only to the restriction on the gelatin content of sweets and made no mention of the restriction on the gelatin content of preserved meat products and ice-cream. It is therefore necessary to consider whether the Italian Republic's right to defend itself was thereby curtailed. A proper examination of that question must, however, lead to a negative answer. It is clear, even from the letter of complaint, that the Commission considers the restriction on the gelatin content of specific foodstuffs and confectionery products contained in the Decreto Ministeriale to be an infringement of the Treaty. The Italian Republic's defence, as is shown not least by its letters sent in reply, has not been prejudiced by the fact that the other restrictions on the use of gelatin laid down in the contested Decreto Ministeriale were also the subject of complaint in the reasoned opinion and in the application to the Court. In the final analysis, as is clear from Case 45/64 (Commission v Italy ( 2 )), the letter of complaint and the reasoned opinion together determine the scope of the subject-matter of the application. Since, however, the reasoned opinion and the application are in any event based on the same grounds and contentions it is not possible to allege, as was finally accepted even by the Italian Government, that the preliminary procedure was in breach of the relevant rules.

(b)

Contrary to the Italian Government's contention it cannot be assumed that the Commission ceased to have a legal interest because, the defendant, after the application had been lodged, amended the original order relating to the gelatin content of sweets. Since, as I have already stated, the subject-matter of an action is determined in the final analysis by the Commission's reasoned opinion, in principle an action still has an object, according to previous decisions of the Court, if the default is only remedied after the period laid down under the second paragraph of Article 169 (See Case 39/72, Commission v Italy ( 3 )). A legal interest in securing a declaration that the Treaty has been infringed certainly continues to exist where, as in this case, the contested order is only repealed after the application has been lodged and even then only partially.

(a)

The Commission takes the view that the contested order constitutes a measure having an effect equivalent to a quantitative restriction within the meaning of Article 30 since it is likely to impede importation of products which have a higher gelatin content and which are lawfully manufactured and marketed in another Member State.

The Italian Government admits that in relation to imports of jellied sweets obstacles to trade had arisen in certain cases but disputes that the importation or marketing of preserved meat products and ice-cream have in fact been prejudiced. In its opinion, it is only possible to establish an infringement of the Treaty by means of proceedings under Article 169 of the EEC Treaty if it can be shown that intra-Community trade has actually been hindered.

However, having regard to previous decisions of the Court, the view of the law taken by the Italian Government cannot be accepted. According to the basic rule first formulated in Case 8/74 (Procureur du Roi v Dassonville ( 4 )) and constantly repeated since then, all national measures “which are capable of hindering, directly or indirectly, actually or potentially, intra-Community trade” are to be regarded as measures having an effect equivalent to quantitative restrictions. That very wide definition encompasses all measures which are likely, when examined objectively, to have a negative effect on imports. In particular, it is not necessary that intra-Community trade is actually hindered or that the effect on trade is capable of quantification. As the Court made clear in its judgment in the Cassis de Dijon case (Case 120/78 ( 5 )), a measure having an effect equivalent to a quantitative restriction is to be presumed where goods capable of being marketed in one Member State cannot be marketed in another Member State because of provisions of domestic law in the latter State. That the contested order is capable of impairing trade in goods which have a higher gelatin content and which come from another Member State requires no further proof.

Contrary to the opinion of the Italian Government, the Commission established that with sufficient clarity during the preliminary procedure. Finally, it is clear from the Commission's statement made in response to a question put by the Court that, for example, the addition of gelatin to preserved meat products is not subject to any statutory regulation in the Federal Republic of Germany or in the Netherlands. In France and Belgium there are no restrictions in respect of some products and in other cases the permissible level of gelatin additive is considerably higher than the maximum of 0.4% allowed in Italy.

With regard to the gelatin content of confectionery products, the statement shows that, in contrast to the position in Italy, no restrictions are imposed in that respect in the four Member States investigated by the Commission. With regard to ice-cream, France and Belgium limit the gelatin content to the same extent as Italy; in the Federal Republic of Germany the permissible level is even lower, whilst in the Netherlands no limit is imposed at all. It is thus established that ice-cream with a gelatin content higher than 1% which has been lawfully manufactured or marketed in the Netherlands cannot be marketed in the Italian Republic as a result of the Decreto Ministeriale of 20 October 1978.

(b)

According to the Cassis de Dijon judgment, ( 6 ) which resulted in the definition given in the Dassonville judgment ( 7 ) being reformulated more narrowly, a measure is not to be regarded as a prohibited measure having an effect equivalent to a quantitative restriction within the meaning of Article 30 of the EEC Treaty if, first, it applies to all products without distinction and, secondly, if it is “necessary in order to satisfy mandatory requirements relating in particular to ... the fairness of commercial transactions and the defence of the consumer.”

The Italian Government seeks to infer from the existence of Council Directive 74/329/EEC of 18 June 1974 on the approximation of the laws of the Member States relating to emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs (Official Journal 1974, L 189, p. 1) that until the harmonization, envisaged in Article 4 of the directive, of the conditions under which gelling agents may be added to foodstuffs has been effected the Member States are free to lay down those conditions themselves. In its opinion, the Community legislature expressly recognized in the third recital in the preamble to the directive that the protection of the consumer must be taken into particular account in relation to the products covered by the directive. Fair trading and consumer protection are of particular importance in relation to the rules governing the use of gelatin since it is possible, with the help of gelatin, to include a large quantity of water especially in the case of preserved meat products and ice-cream.

However, that argument cannot be accepted for several reasons. The defendant's basic premise that there are no Community rules governing the permissible gelatin content of foodstuffs and that therefore, in principle, it is for the Member States to regulate that matter, is correct. It is not however necessary to decide whether, as the Italian Government contends, gelatin is to be regarded as a thickening or gelling agent within the meaning of Article 1 of the directive and therefore in principle within the scope thereof. The decisive factor is that gelatin is not included in the substances listed in Annex I to the directive, which, according to Article 2 thereof, are the only substances whose use as emulsifiers, stabilizers, thickeners or gelling agents may be authorized by the Member State. The provisions of Articles 5 to 8 of the contested directive relating to the protection of public health and the protection of the consumer against adulteration only apply to the products referred to in Annex I thereto. If gelatin were regarded as a thickening or gelling agent within the meaning of Article 1 of the directive it would follow that its use as an additive in foodstuffs would in any event be prohibited under Article 2 because it is not referred to in Annex I. Article 9 of the directive provides that Article 2 is not to apply inter alia to edible gelatin. It must therefore be presumed that the directive does not prohibit the Member States from authorizing the use of gelatin as an additive to foodstuffs in addition to those substances referred to in Annex I thereto. Therefore, since the matter is not dealt with in the Community legislation, it is for the Member States, as the Court has stated inter alia in the Gilli case, ( 8 ) to regulate all matters relating to production, distribution and consumption on their territory, subject however to the condition that rules adopted do not infringe Article 30 of the EEC Treaty.

Even if the Italian Government's argument that gelatin constitutes a thickening or gelling agent within the meaning of Article 1 of the directive is accepted the conclusion will be the same. Article 4 of the directive, which provides that the Council is to harmonize as soon as possible the conditions under which the substances in question may be used, may certainly not, as a provision of secondary Community law, be interpreted as meaning that as long as harmonization has not been effected the Member States are empowered to adopt measures which are not consistent with the provisions of Articles 30 and 36 of the EEC Treaty.

According to previous judgments of the Court, an obstacle to trade is only to be regarded as other than a measure having an effect equivalent to a quantitative restriction if it is necessary in order to satisfy the imperative requirements of fair trading and consumer protection. Accordingly it is necessary, in each individual case, to weigh the requirements of the free movement of goods in the common market against any legitimate interests in protection. In that respect the principle of proportionality requires, as the Court has consistently held, that if a Member State has a choice between various measures to attain the same objective “it should choose the means which least restricts the free movement of goods” (Case 261/81, Walter Rau Lebensmittelwerke v De Smedt PvbA ( 9 )). In particular, the Court has held on many occasions (judgments in Cases 120/78, 788/79, 27/80, 130/80, 220/81 and 261/81 ( 10 )) that an absolute prohibition on imports cannot be justified on the ground of consumer protection where confusion on the part of the consumer can be prevented by appropriate labelling. In this case, as the Commission has rightly contended, confusion on the part of the consumer may be prevented by providing that notice of the gelatin content of the products in question must be given. In the case of packed products the information may be provided without difficulty on the packaging, whilst in the case of unpacked products information regarding their contents may be required to be given in some other sufficiently clear manner.

In that connection it is not possible to uphold the Italian Government's objection that the labelling required by Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer (Official Journal 1979, L 33, p. 1), according to which the ingredients of foodstuffs are simply to be recorded in descending order of weight, constitutes insufficient protection for the consumer in this case. The general, socalled “horizontal” Community rules contained in that directive, which apply to all foodstuffs, do not, in anyevent, as the Commission has correctly observed, preclude the adoption of special rules applicable only to specific foodstuffs.

In particular, according to Article 4 (2) of the Directive 79/112 Community law may provide that in addition other particulars must appear on the labelling. In the absence of such Community provisions the Member States may, according to the second subparagraph of Article 4 (2), make provision for such particulars in accordance with the procedure laid down in Article 16 of the directive.

It must therefore be concluded that the provision in the contested Decreto Ministeriale of 20 October 1978 laying down the maximum gelatin content constitutes a measure having an effect equivalent to a quantitative restriction within the meaning of Article 30.

(c)

It remains to examine whether, as the Italian Government contends, the measure is justified under Article 36 of the EEC Treaty on the ground of the protection of health.

It is not possible to infer from Directive 74/329, which was relied upon by the Italian Government, that the Community legislator thereby recognized in principle the danger of adding animal gelatin to foodstuffs. As has been shown, the directive permits the use of edible gelatin without restriction.

The Italian Government, with particular reference to the judgment of the Court in Case 174/82 (Sandoz ( 11 )), regards the limitation of the gelatin content of foodstuffs as justified since gelatin may be manufactured from tanned animal hides and may, to that extent, contain substances such as bromine and chlorine which constitute a danger to health.

However, the Sandoz judgment is not relevant to this case. The Sandoz case concerned the use of vitamins, which are not as a general rule harmful in themselves but may have harmful effects on a person's health if taken in excess. In view of the uncertainty concerning the scientific determination of the critical quantities and precise effects the Court has recognized that it is for the Member States, in the absence of harmonization, to decide what degree of protection of the health and life of humans they intend to assure, having regard however to the requirements of the free movement of goods within the Community.

However, in contrast to the position relating to vitamins, it appears that, according to scientific research, the consumption of animal gelatin, even in large quantities, does not as such endanger the health of the consumer. At any rate the defendant's representative gave no reply to a question on that point. Such an assumption, which is confirmed according to the Commission by investigations conducted by the World Health Organization and by the United Nations Food and Agricultural Organization, is supported not least by the fact that the use of gelatin is not restricted either by Community law or by the laws of certain Member States. If the Italian Government's contention that the consumption in large quantities of gelatin containing chemical impurities might lead to health dangers is accepted, as it must be, the dangers result not from the use of gelatin as an additive but from the aforementioned chemical substances, which should, if possible, be eliminated from foodstuffs. In order to avoid the danger alluded to by the Italian Government it is sufficient if the use of gelatin containing chemical impurities is prohibited. In any event, such a measure would hinder the free movement of goods guaranteed by the Treaty to a lesser extent than the contested provisions laying down the maximum gelatin content.

C —

In conclusion, I therefore advise the Court to declare that the Italian Republic has, by restricting the importation., of foodstuffs which contain animal gelatin and which have been lawfully manufactured and marketed in. another Member State, failed to fulfil its obligations under Article 30 of the EEC Treaty.

The Court should also order the parties to bear their own costs.