Report for the Hearing in Case C-344/90

I — Facts and legal background

A — The national rules in question

The milk used in the manufacture of cheese contains bacteria. Some of them, clustridia tyrobutyrica, disturb the maturing process of cheeses by making them swell abnormally. They also give rise to undesirable odours. There are various methods for getting rid of the bacteria, including the addition of nitrate to the cheese during its manufacture.

The addition of nitrate to cheese is banned in France.

The ban is the result of two decrees adopted pursuant to the Law of 1 August 1905 on fraud and misrepresentation in relation to products or services (Journal Officiel de la Republic Française, 5 August 1905, p. 4813) — the rules.

The Law imposes a penalty of three months to two years imprisonment and/or a fine of FF 1000 to FF 250000 for adulterating foodstuffs intended for human or animal consumption or for marketing adulterated, spoilt or toxic foodstuffs.

Making that rule more specific, two decrees ban the use in the manufacture of foodstuffs of any additive which has not previously been authorized by ministerial order. The decrees in question are the Decree of 15 April 1912 on the rules of public administration implementing the Law of 1 August 1905 {Journal Officiel de L République Française, 29 June 1912, p. 5710) and Decree No 674 of 18 September 1989 on additives which may be used in foodstuffs intended for human consumption (Journal Officiel de L République Française, 19 September 1989, p. 11811).

From the documents before the Court it appears that there has been no order so far in implementation of those decrees authorizing the use of nitrate in the manufacture of cheese. Such use must therefore be regarded as prohibited.

B — Pre-litigation procedure

By letter dated 8 February 1988 the Commission informed the French Government that in its view the French rules were contrary to Article 30. It considers that the ban on the use of nitrate is likely to create an obstacle to the importation into France of cheeses lawfully manufactured in other Member States.

Furthermore, the Commission states that the rules cannot be justified by the need to protect public health, having regard to Article 36 of the EEC Treaty. In its view the addition of nitrate to cheese, within certain limits (50 mg per kg), is harmless. That has been established by the Committee responsible, in the Food and Agricultural Organization and the World Health Organization, for drawing up the Codex Alimentarius containing standards for the manufacture of foodstuffs. Thus it has thus been shown that a person consuming on a daily basis 50 g of cheese to which nitrate has been added within the abovementioned proportion would consume only 2.5 mg of the substance per day. That, in the Commission's view is a very small quantity in relation to the maximum amount of nitrate which a person may consume without risk — acceptable daily intake — fixed at 300 mg for a person weighing 60 kg.

In its reply of 25 May 1988 the French Government denies that its rules are likely to obstruct intra-Community trade. As proof, it points out that imports into France of cheeses from the Netherlands increased in 1987 from 5.9% in relation to the previous year and in 1990 amounted to 50061 tonnes as against 19000 tonnes in 1980. Furthermore it states that the contested ban applies in practice only to cheeses containing an excessive amount of nitrate. Up to 15 mg per kg of nitrate would seem acceptable in so far as all cheese naturally contains a certain amount.

Alternatively, the French Government considers that the rules are lawful under Article 36. in its judgments in Case 304/84 Ministère Public v Müller [1986] ECR 1511 and Commission v Germany [1987] ECR 1227, the Court held that rules prohibiting the use of an additive are compatible with the Treaty only if the substance in question is dangerous to health and does not meet a genuine need especially from a technological point of view. The French Government considers that those two conditions are satisfied in the present case.

As regards the first condition, the French Government maintains that nitrate does present a danger to human health. It could give rise to carcinogenic substances in the alimentary canal. Furthermore the French Government maintains that the Commission's conclusions based on the Codex Alimentarius are mistaken on two grounds. First, the Codex Alimentarius does not authorize nitrate as an additive in cheese. It is a purely informative reference work describing manufacturing methods in use in certain States. In addition, the use of nitrate is not regarded by the Codex as a method to be used for all cheeses, as the Commission claims, but only for certain of them.

As regards the second condition laid down by the Court, namely the technological need for nitrate, the French Government observes that there are other methods for eliminating the bacteria responsible for the gas in cheeses: bactofugation, the addition of lysozyme or improvement in the quality of the milk used, by means of supervision of animal feed and milking hygiene. Those methods should be used in preference to nitrate in so far as they present no risk to the health of consumers.

On 25 November 1988 the Commission sent the French Government a letter of formal notice. In that letter it maintains, first, that nitrate presents no danger to health and secondly is necessary in the manufacture of certain cheeses.

On the first issue it denies that nitrate leads to the formation of carcinogenic substances.

Such substances have also been found in cheeses manufactured without the addition of nitrate.

On the second issue it states that, in assessing the need for nitrate, account must be taken not only of manufacturing techniques in France but also of those used in other Member States. Nitrate is necessary in certain areas of the Community where for climatic reasons cattle are fed for a long period of the year on silage. Such feed increases the number of bacteria in milk. Only nitrate is capable of destroying all such bacteria, as the Codex Alimentarius and Professor Walker, an expert whose report the Commission produces, recognize.

Furthermore, the Commission considers that the processes proposed by the French Government do not constitute a valid alternative to the use of nitrate. The first of those processes, bactofugation, is suitable only for certain cheeses. Some bacteria which need to be removed are resistant to the second process, the addition of lysozyme. As for the third, the use of better quality milk, that cannot be achieved in certain areas of the Community in so far as it would require a change in cattle feed.

In its reply of 20 February 1989 the French Government amplifies the argument it has already put forward in relation to the effects of nitrate on health, whether or not nitrate is needed as an additive and the possibility for an importer to obtain a authorization to market in France cheeses to which nitrate has been added.

With regard to the effect of nitrate on health, the French Government makes two observations. First, it refers to the fact that the Commission has submitted to the Council proposals for the protection of fresh water, coastal water and sea water from pollution by nitrates due to certain agricultural practices. In so doing it admitted that nitrate was toxic. Secondly, the French Government challenges the concept of acceptable daily intake; the concept is relevant only to persons weighing 60kg, the basis on which the intake was calculated, and it was established at a time when the carcinogenic effects of nitrate were not yet known. Since their discovery it is necessary to reassess the acceptable daily intake; the Scientific Committee for Food had begun research for that purpose. The French Government adds that Professor Walker's report is based on out-ofdate scientific data.

With regard to the technological need for nitrate the French Government observes that it does not appear to be the most appropriate means of eliminating claustridia tyrobutyrica. Its action is not specifically directed against those bacteria. In addition it is effective only for a limited period; accidents will occur in the maturing process of certain cheeses. On the other hand, lysozyme, which it suggests should be combined with the use of better quality milk, has both a more specific and prolonged action on the bacteria which need to be destroyed.

Finally, the French Government states that importers may apply to the designated authorities for authorization to market cheeses containing nitrate in France. Authorization will be granted if the use of the additive proves to be absolutely necessary.

On 25 January 1990 the Commission sent the French Government a reasoned opinion in which it maintained its position.

In addition to the arguments which it had already put forward on the harmlessness of nitrate it stated that nine Member States allowed the marketing in their territory of cheeses containing nitrate.

Furthermore, the Commission considers that the existence of alternative processes should not be taken into account in assessing the need for nitrate. The sole criterion is its capacity to destroy bacteria causing the swelling of certain cheeses.

In its reply of 29 March 1990 the French Government repeats the substance of the arguments already put forward. It adds that the Member States are entided to ban certain additives in their territory. The Court has, nevertheless, laid down two conditions that they must comply with: first, a procedure must be established for traders to apply to the national authorities for authorization to use the banned additive; secondly authorization must be granted where the substance in question meets a genuine need and presents no risk to public health. The French Government states that there is such a procedure in France that satisfies those requirements.

II — Procedure before the Court

The Commission's application was registered at the Court Registry on 22 November 1990.

The Commission claims that the Court should:

The French Government contends that the Court should:

By order of 24 April 1991 the Spanish Government was given leave to intervene in support of the Commission.

III — Arguments of the parties

The Commission, supported by the Spanish Government, considers that the rules are prohibited by Article 30 and are not justified under Article 36. The French Government denies the two claims.

Are the French rules prohibited by Article 30?

The Commission considers that Community law allows nitrate to be added to foodstuffs. Two principles apply.

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), as amended by Council Directive 67/427/EEC of 27 June 1967 on the use of certain preservatives for the surface treatment of citrus fruit and on the control measures to be used for the qualitative and quantitative analysis of preservatives in and on citrus fruits (OJ, English Special Edition 1967, p. 169), contains a list of additives which Member States may authorize. That list includes nitrate.

Secondly, Member States retain the right to prohibit the use of the additives on the list either in respect of certain foodstuffs or all foodstuffs where the additives are not necessary for their manufacture. Moreover, national legislation may not infringe Articles 30 and 36 of the Treaty. According to the Commission, the French rules infringe Article 30: they prevent the importation into France of certain cheeses made in other Member States.

The French Government denies that its rules constitute a restriction on trade prohibited by Article 30. It relies on the fact that imports into France of cheeses from the Netherlands have increased in recent years.

In support of the Commission, the Spanish Government argues that Member States may determine the foodstuffs to which the substances authorized by the directive may be added but they must not adversely affect free movement of goods. In the present case the French rules obstruct the importation of certain cheeses. That is prohibited by Article 30.

Are the French rules justified under Article 36f

In the Commission's view the French rules are unjustified. They would be lawful only if certain conditions were satisfied (Case 174/82 Sandoz [1983] ECR 2445; Case 247/84 Motte [1985] ECR 3887; Case 300/84 Muller, cited above, and Case 178/84 Commission v Germany cited above).

First, the addition of nitrate to cheese must present a risk to health. In addition to the arguments put forward at the pre-litigation stage, it makes four further points. First it observes that nitrate was authorized by the directive after numerous scientific tests. Secondly, it points out that in a recent report dated 19 October 1990 the Scientific Committee for Food confirmed that the addition of 50 mg of nitrate per kg of cheese presented no risk. The Commission also states that there is no risk to the health of children; the acceptable daily intake for them is not exceeded. Lastly, it states that nitrate disappears as the cheese matures.

Secondly there must be no technological need for the nitrate. The Commission makes two observations in that respect. It states that the need for nitrate depends solely on its capacity to destroy the bacteria responsible for the swelling of cheese; in its view it is irrelevant that other processes may be used. Alternatively it claims that the methods proposed by the French Government do not appear acceptable. France ought not impose a process used in its territory: the need for an additive must be assessed with regard to the techniques practised in the country of exportation. Furthermore, the methods advocated by the French Government would be difficult to apply in certain areas of the Community.

Finally the Commission states that it is for the French Government to show that the two conditions mentioned above are satisfied: otherwise the rules cannot be justified. The burden of proof should not lie on the traders when, under the procedure to which the French Government refers, they seek authorization to use nitrate. In that respect the Commission states that in its opinion no authorization will ever be given at the conclusion of the procedure: the French authorities have an inviolable and absolute principleof opposition to the addition of nitrate in cheeses; therefore any request can meet only with a categorical refusal. Furthermore, in its letter of formal notice and reasoned opinion, the Commission requested the French Government to authorize the addition of nitrate in cheeses. That request was turned down.

In conclusion the Commission states that according to its information nine Member States accept the marketing in their territory of cheeses containing nitrate. That shows that in those States nitrate appears necessary and without danger.

The French Government considers that its rules are justified under Article 36. In the abovementioned case of Muller and Case C-42/90 Bellon [1990] ECR 4863, the Court recognized that Member States are entitled to prohibit the use of a substance authorized by Community law. The right was made subject to two conditions.

The first condition is that the Member State concerned should establish a procedure enabling traders to apply for authorization to use the banned product. The French Government confirms that there is such a procedure in France. It was established by the contested rules and by a circular of 8 August 1980 on applications for authorization to use substances intended to be added intentionally to foodstuffs (Journal Officiel de L République Française, 25 September 1980, p. 8544). The French Government observes that the authorities designated to consider applications have so far received none.

The second condition laid down by the Court is that at the conclusion of the procedure authorization must be granted to persons who have made application where the additive presents no risk to human health and meets a technological need. Those two matters must be proved by the persons concerned and are verified by two scientific bodies. The French Government repeats that neither the harmlessness nor the need for nitrate has so far been established.

As regards the first point, the French Government refers to the danger which nitrate represents to human health. It puts forward two arguments.

In the first place it reiterates that there is a risk that the acceptable daily intake will be exceeded if cheeses containing nitrate are marketed in France. To assess that risk account must be taken of two phenomena. First, France is the world's prime consumer of cheeses. Secondly, drinking water and green vegetables in France contain a high, indeed excessive, level of nitrate. In support of that statement, the French Government produces extracts from a report by the Directorate-General for Health. The health of children could be affected: their acceptable daily intake could be exceeded if nitrate used in the manufacture of cheese were added to the nitrate present in the water and vegetables which they consume in large quantities.

Secondly the French Government challenges the scope of the scientific reports on which the Commission relies. They do not bind the Member States. The Court approved that interpretation in the aforementioned Motte case. In addition, in its report of 19 October 1990, the Scientific Committee for Food confirmed the French Government's position by recognizing that the carcinogenic potential of nitrate could not at present be precisely assessed. For that reason the Committee recommended that other processes be substituted for nitrate, in particular the improvement of the manufacturing conditions for foodstuffs.

As regards the second matter on which proof has to be adduced by traders, namely the need for nitrate, the French Government maintains that it is free to ban nitrate on the ground that other less dangerous techniques are also effective. It suggests that better quality milk should be used and lysozyme added. In its view it is better to perfect production techniques than use a powerful but dangerous additive in order to remedy the failings of faulty raw materials.

The French Government concludes by observing that the Commission has initiated actions for failure to fulfil obligations against the three Member States which do not accept nitrate as an additive in cheese (France, Greece and Italy). It wonders whether the Commission is not attempting, by way of these actions, to obtain through the Court harmonization which, under the Treaty, should be negotiated in the Council.

The Spanish Government considers that the French rules are not justified under Article 36. It puts forward two considerations in that respect.

In the first place it states that the rules are not necessary to protect public health or to inform consumers. The addition of 50 mg of nitrate per kg of cheese presents no risk; health could be protected by less restrictive measures than a ban. Furthermore consumers could be informed without the free movement of goods being obstructed (for example, by appropriate labelling).

In the second place, in reliance on the aforementioned Bellon case, the Spanish Government states that to ban the use of an additive authorized by the directive is justified only on certain conditions. First, the substance in question must not meet a technological need. Secondly, it must present a risk to public health. Thirdly traders must be able to apply for authorization to use the banned additive. In the Spanish Government's view the French rules do not satisfy those requirements.

1 Language of the case: French.