Report for the Hearing in Case C-95/89

I — Facts and legal background

Article 5 of Italian Law No 283 of 30 April 1962 {Gazzetta Ufficiale detta Repubblica Italiana No 139 of 4 June 1962) governing the health aspects of the production and sale of food and drink is worded as follows:

It appears from the Ministerial Order of 31 March 1965 {Supplemento ordinario, Gazzetta Ufficiale della Repubblica Italiana No 101 of 22 April 1965) as subsequently updated, that nitrates may be used in Italy only for the manufacture of prepared or processed meat. In consequence the marketing of cheeses containing nitrates is prohibited.

Since it considered that this was an unjustified obstacle to intra-Community trade, on 6 July 1984 the Commission requested the Italian Government to submit its observations.

On 11 September 1984 the Italian Government replied that it was entitled to ban the marketing of cheese containing nitrate additive in its territory. Council Directive 64/54/EEC of 5 November 1963 on the approximation of the laws of the Member States concerning the preservatives authorized for use in foodstuffs intended for human consumption (OJ, English Special Edition 1963-1964, p. 99) allowed Member States to ban the use of certain additives, including nitrate, when their use was not technologically justified.

Article 2 of that directive, as amended by Council Directive 67/427/EEC of 27 June 1967 (OJ, English Special Edition 1967, p. 169), is worded as follows:

Since it considered that the explanations of the Italian Government were not convincing, on 19 March 1986 the Commission issued a first reasoned opinion according to which, by prohibiting the importation of cheeses containing more than 2 mg of nitrates per kg and lactosérum containing more than 50 mg of nitrates per kg lawfully produced and marketed in other Member States and within the limits of nitrate content internationally recognized as acceptable for the protection of health, the Italian Republic had failed to fulfil its obligations under Article 30.

On 16 February 1987 the Italian Government challenged that point of view. In its opinion the ban was justified on the basis of considerations relating to the protection of health. The average daily intake of nitrate by the Italian population was 312.75 mg, which was higher than the acceptable daily intake of 300 mg laid down by the Food and Agriculture Organization of the United Nations and the World Health Organization Expert Committee. There was no technological need for the addition of nitrates. Only the fraudulent use of skimmed-milk powder for animal feed could explain the presence of the additive in cheese. The ban did not infringe the principle of proportionality implicit in Article 36 of the Treaty. The maximum amount of nitrate authorized for the treatment of prepared meat could not be reduced since if a lesser amount were used it would not be effective against botulism. Furthermore the natural presence of nitrate in water and in food of vegetable origin could hardly be reduced.

In view of the Italian Government's answer the Commission instructed an expert, Professor Walker, to make a study of the risk to human health which the addition of nitrates to cheese might entail in view of the dietary situation in Italy.

The expert's conclusions may, essentially, be summarized as follows:

In view of those considerations, on 21 October 1988 the Commission issued a second reasoned opinion in which it took the view that in banning the importation of cheeses lawfully produced and marketed in other Member States, to which nitrate had been added during the production process within the limits permitted by international scientific opinion (50 mg/kg), the Italian Republic had failed to fulfil its obligations under Article 30 of the Treaty.

On 11 and 23 January 1989 the Italian Government requested the Commission to inform it of the legislative position in other Member States which allowed the addition of nitrates in the manufacture of cheeses.

On 2 February 1989 the Commission forwarded the information. It asked the Italian Government to state within a period of one month whether it intended to comply with the reasoned opinion.

There was no reply to that request.

II — Procedure

The Commission's application was registered at the Court Registry on 20 March 1989.

The written procedure followed the normal course. Upon hearing the report of the Judge-Rapporteur and the views of the Advocate General the Court decided to open the oral procedure without any preparatory inquiry. It did, however, decide to put one question to the Italian Government. The reply to that question is set out under heading IV of this Report.

The Commission claims that the Court should:

The Italian Government contends that the Court should:

III — Arguments of the parties

The Commission states that, according to the case-law of the Court, Member States may, by a measure of general scope, authorize on their territory the use of specific additives either for all products, a limited range of products, or for certain uses.

The use of an additive must however be authorized if, in view of the results of international scientific research and the eating habits in the importing Member State, it meets a genuine technological need and presents no danger to public health.

In its opinion, technological need must be assessed on the basis not only of the manufacturing methods of domestic producers but also of those of other Member States. In the present case the addition of nitrates is justified by the need to inhibit certain anaerobic organisms, in particular Clostridia, which give rise to the formation of gas. Similarly the addition of nitrates is useful in the manufacture of cheeses of medium or slow maturation where cattle have been fed on silage. There is special need for such use in Northern Europe where those cheeses are produced and where it is necessary to use such fodder for a longer period of the year than in Italy.

Furthermore, States which ban the use of nitrates authorize the use of other additives for similar technological reasons. Thus, Italy allows the addition of formaldehyde in the manufacture of Grana Padano and hexamethylene tetramine in the manufacture of Provolone.

As regards public health, the Commission alleges that consumption of nitrates in Italy is far from reaching the acceptable daily intake fixed by the FAO at 300 mg. Recent research estimates consumption to be 245 mg/day. In any event, the consumption of cheeses containing nitrates would lead to a negligible increase (less than 1%) in the daily consumption of nitrates.

The Commission considers more particularly the position of the elderly, pregnant women and young children.

As regards the elderly and pregnant women, it points out that the acceptable daily intake was established on the basis of scientific studies which took account of the variable nature of human sensitivity and special circumstances such as gestation.

The acceptable daily intake does not concern children of less than 12 weeks since they do not have solid food. After 12 weeks the normal gastric function is working so that there is no contraindication to their consuming cheeses containing nitrates within the limits recognized. Assuming that they eat only cheese containing the maximum authorized concentration of 50 mg/kg, they would have to consume one-tenth of their weight per day to reach the acceptable daily intake. If the nitrate intake of some children exceeds the authorized limit, the cause must be sought in other components of their diet.

Finally, the low quantities of nitrites which are formed from the consumption of cheese containing nitrate is of no toxicological significance. Furthermore nitrates do not involve an increase in the frequency of carcinogenic nitrosamines.

The import ban is thus a completely disproportionate and unjustified obstacle to trade from the point of view of Article 36 of the Treaty. In the absence of any effective measure to reduce the natural absorption of nitrates, in particular those originating from fruit and vegetables in the production of which fertilizers have been used, the ban is also arbitrary discrimination prohibited by the second sentence of Article 36.

The Italian Government contends that its rules on additives comply with the Community rules. Directive 64/54 preserved the power of Member States to ban the use of certain additives in the manufacture of foodstuffs.

That power is also recognized by Council Directive 89/107 of 21 December 1988 — designed to replace Directive 64/54 — on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption (OJ 1989 L 40, p. 27). It is stipulated in Annex II to that directive that food additives can be approved only provided that: there can be demonstrated a reasonable technological need and the purpose cannot be achieved by other means which are economically and technologically practicable.

It is therefore for the Commission to show that there is a technological need for nitrates, which it has not done, and, even assuming that there is a need, that the purpose cannot be achieved by other means.

Such a need does not exist. The use of nitrates is indispensable only where the cheese is made from milk which does not have the requisite microbial quality and, more particularly, when it comes from cows fed with silage of mediocre quality. The manufacturing process of the Parmiggiano Reggiano shows that it is possible to produce quality cheese without additives.

The Italian Government states that the use of milk of doubtful quality is unacceptable in a dairy market which has structural surpluses. Such a process is furthermore contrary to the objective of Directive 89/107, according to which additives should not be used to disguise the effects of the use of faulty raw materials or of undesirable (including unhygienic) practices (see Annex II to the directive).

The protection of health also justifies the marketing ban on such cheeses. In such an area it is necessary to tread carefully, especially as in Italy the acceptable daily intake (300 mg) is exceeded, average intake amounting to 312 mg. In those circumstances there is no reason to increase by however little that already very dangerous level.

On the authority of an opinion from the Experimental Institute for Milk and Cheese, Lodi, the Italian Government challenges the Commission's arguments that there is no risk to human health. In the case of infants, because of the high PH level in their stomachs, nitrates are converted into nitrites. Such nitrites can lead to the formation of carcinogenic compounds. Large quantities of cheese consumed by children would lead to a consumption of nitrates well in excess of 5 mg per kg of bodyweight. Furthermore the consumption of that additive leads to greater amounts of nitrites forming than Professor Walker estimates. Moreover the Commission minimizes the danger of the appearance of carcinogenic nitrosamines.

Finally it is necessary to take account of the natural presence of nitrates in certain foods, such as fruits and vegetables, the consumption of which is greater in Italy than in the other Member States. Since it is impossible to reduce the consumption of nitrates from that origin it is necessary to limit their use to what is strictly necessary and to ban them when there is a clanger that the tolerance levels will be exceeded.

IV — Question put by the Court and the Italian Government's reply

The Court requested the Italian Government to give particulars of the procedures for and terms under which the authorization orders, referred to in Articles 5(g) and 22 of the Law No 283 of 30 April 1962, are adopted and updated and to state whether and on what basis individuals have access to or may take part in such procedures.

The Italian Government replied that authorization orders for the use of additives are adopted by the Minister for Health after an opinion has been given by the Health Council. The same procedures apply to the amendment or withdrawal of authorizations which have already been granted.

Authorization of new additives or new cases, together with the permitted dosage of additives already authorized, is granted upon application by the undertakings or trade associations concerned.

In that respect applicants must state reasons, especially for the technological need for the use requested.

The Ministry of Health considers the application in conjunction with its technical department (the Institute of Health) and if it considers the application justified it drafts a report for the Health Council.

In the event of a favourable opinion from the Health Council and after obtaining the opinion of the Council of State pursuant to Article 17 of Law No 400/1988, the Minister for Health adopts the authorization order which is then published in the Gazzetta Ufficiale della Repubblica italiana.

1 Language of the case: Italian.