Opinion of Advocate General Gulmann
Mr President,
Members of the Court,
1. These three cases have been brought by the Commission under Article 169 of the EEC Treaty and concern the ban, in Italy, Greece and France, on the importation and marketing of cheeses to which nitrate has been added at the manufacturing stage.
2. An account of the legislation in the three Member States is contained in the Reports for the Hearing. It can be summarized as follows:
The harmonization directives on the subject
3. Nitrate is referred to in the annex to Council Directive 64/54/EEC of 5 November 1963 on the approximation of the laws of the Member States concerning the preservatives authorised for use in foodstuffs intended for human consumption. The Court has had occasion to interpret Directive 64/54/EEC many times and has decided that if an additive is included in the list in the annex to the directive that indicates that the Member States may authorize the use of the substance in question but is not obliged to do so. Most recently, in its judgment of 13 December 1990 in the Bellon case, the Court stated:
4. However, it is also clear from the settled case-law of the Court that application of Article 30 of the Treaty is not excluded even where harmonization directives have been adopted and that the basis for applying Article 36 will only be removed when Community directives prescribe complete harmonization of all the measures necessary to ensure the protection of health and establish Community procedures for supervising compliance with those measures.
Do the national rules constitute an obstacle to trade within the meaning of Article 30?
5. The Commission has stated that eight other Member States permit nitrate to be added in the manufacture of certain cheeses. In most cases a maximum limit of 50 mg per kg of cheese is set, but in certain situations a nitrate content of up to 150 mg per kg cheese is permitted.
6. In this connection France and Greece have claimed that the existing tolerance thresholds make it possible for most cheeses to be imported. According to the consistent case-law of the Court such a circumstance is irrelevant when it can be established that rules in the importing State impede the importation of goods lawfully produced in other Member States. France further pointed out that imports from the Netherlands to France increased even for cheeses which, under Netherlands manufacturing rules, may be manufactured with added nitrate, and claimed that that shows that the prohibition at issue does not constitute a barrier to trade. The Court's case-law shows clearly that that circumstance cannot be regarded as relevant.
Are the national rules justified on public health grounds under Article 36?
7. The crucial question in these cases is therefore whether the prohibitions against the marketing of cheese with added nitrate is justified with regard to the protection of human health under Article 36.
8. It will be clear from what follows that there is a solid basis in the findings of international scientific research to support the view that nitrate does in fact meet a real need in the production of certain cheeses and that the addition of nitrate within specifically defined limits does not present a risk to health.
Does nitrate meet a real need, especially a technological one?
9. The Commission has claimed that the addition of nitrate is necessary in the manufacture of certain cheeses in order to prevent the growth of anaerobic organisms of the Clostridium tyrobutyricum type. Those bacteria disturb the maturing process and make the cheese blow, that is to say, there is a buildup of gas and a bad smell. The bacteria are to be found particularly in milk from cows which have been fed with silage. The problem arises in cheeses which take a medium to long time to mature, for example, Gouda, Edam, Tilsiter Samsø etc. There is therefore particular reason to use nitrate in Northern Europe where it is necessary to use silage for a large part of the year and where cheeses of that type are manufactured.
10. The defendant Member States have not contested the fact that there may be a technological need to kill the bacteria which cause late blowing or that nitrate is an appropriate means of achieving that end. On the other hand, the Member States have claimed that the use of nitrate is not technologically necessary because there are other, less harmful, methods which can prevent Mate blowing.
11. The Court of Justice has not previously decided whether Member States can refuse to allow the marketing of a product by reference to the fact that the additive used is not necessary to meet a technological need because the desired objective can be realized by other means.
12. The present cases raise the question whether the requirement that a technological need be met should be given a content different from and more extensive than that which can be inferred from the Court's case-law. Should the possibility offered in Article 36 for justifying a prohibition on importation on the ground of the risk to health presented by a product not merely cover the possibility of preventing the importation of additives that do not serve any purpose but also extend to the possibility of preventing the importation of additives which can be replaced by other substances which are presumed to be less harmful?
13. Valid reasons may be adduced for an affirmative reply to that question.
14. The crucial question is, however, whether the Member State of importation should be able to ensure that the Member State of production only approves additives which cannot be replaced by other methods.
15. Since the defendant Member States, as mentioned above, have not disputed that the addition of nitrate could meet the technological need that has been found to exist, in my view it should be held that the Member States' prohibition cannot be justified on the basis that there is no technological need for the addition of nitrate to certain specified cheeses.
16. For the sake of completeness, I should, however, mention that from the information available in the cases, as far as I am able to assess it, there is no basis for considering that the technological need demonstrated can be wholly met by the use of other additives or other production methods.
17. The three defendant Member States have contended that late blowing can be controlled by (1) the addition of lysozyme, which is an enzyme extracted from albumen; (2) bactofugation, that is to say the centrifugádon of milk; (3) improvement of cattle nutrition, that is to say either by not using silage as fodder or the use of better quality silage; and (4) an improvement in milk hygiene.
18. In my view the Court's judgment in the Beer case can be used to support a rejection of the submission that cheese should be manufactured on the basis of a raw material other than that utilized, that is to say, from milk from cows that have either not been fed with silage or have been fed with better quality silage.
Does nitrate present a risk to public health?
19. Comprehensive material has been submitted to the Court containing research and evaluation of the possible harmful effects on health of nitrate, including various scientific reports, extracts from the literature on the subject etc. I do not believe it necessary to review all those documents. As is clear from the above-cited judgment in the Bellon case, in its case-law the Court has established that the question of health risks must be judged on the basis of international scientific research and in addition has specified that particular weight should be given to the conclusions drawn by the Community's Scientific Committee for Food and the Codex Alimentarius Committee of the FAO and the WHO.
20. The findings of the report may be summarized as follows:
21. The defendant Member States have disputed the proposition that in assessing the risk to health presented by nitrate the starting point to be taken should be a generally established ADI, because no account is thereby taken of specially sensitive groups of persons such as old people, pregnant women and children. Especially as far as infants are concerned, the Member States have claimed that as a result of the higher PH content of their stomachs nitrate is to a large extent reduced to nitrite.
22. To summarize, the question whether nitrate, judged on the basis of international scientific research, presents a risk to public health can accordingly be answered as follows:
23. As is clear from the above-cited judgment in the Bellon case, in assessing the risk to health of an additive account must also be taken of eating habits prevailing in the importing Member State.
24. The arguments put forward by the Member States in that respect concentrate mainly on showing that the established ADI is exceeded as a result of their respective population's eating habits in respect of all foodstuffs, including water, containing nitrate.
25. The Commission contests the accuracy of much of that information but otherwise employs a different approach in its arguments on this point from that of the Member States. The Commission thus takes cheese-eating habits as its basis. In the Commission's view it is crucial that even where it is assumed that all cheese contains the maximum authorized quantities of nitrate, that is to say 50 mg per kg, cheese consumption can only result in an insignificant rise, namely of 2.1 mg, corresponding to less than 1%, in daily nitrate intake. Since by no means all cheese has added nitrate and the residual nitrate concentration in cheese to which nitrate is added is, as a rule, well under 50 mg per kg, the Commission states that to allow nitrate to be added to cheese will probably result in a rise of only 0.5 mg in daily intake.
26. In my opinion the Commission is right in that view. Where international scientific research has established that the use of a specific additive in a specific product in a specified quantity cannot be regarded as a risk to health, the condition that the eating habits in the importing Member State must be taken into consideration means that an assessment must be made as to whether particular eating habits in respect of the product in question in the importing Member State can create special health problems in that Member State. That must in any event apply where international scientific research (see above) has laid down that the potential nitrate intake from that source is insignificant in relation to the established ADI.
27. The Member States have not produced any information casting doubt on the fact that, on the basis of the cheese-eating habits in the three Member States, it can be concluded that the daily quantity of nitrate originating from that source is insignificant. It must therefore be assumed that the addition of nitrate to cheese does not present a risk to health in the three Member States.
28. In view of the foregoing I believe that to refuse to authorize the importation of cheeses in respect of which there is a technological need for the addition of nitrate and which contain a residual nitrate concentration not exceeding that which international scientific research has declared to be acceptable from a health point of view is not justified on health grounds and such refusal is thus contrary to Article 30 of the Treaty.
Is the obligation of the Member States to give authorization conditional on submission of an application by a trader?
29. It is clear from the case-law of the Court that legislation which prohibits generally the use of additives unless positive authorization is given complies with Articles 30 and 36 of the Treaty. However, the Court has laid down a condition that the Member State should establish a procedure whereby the trader may request authorization to use additives. Authorization must be given if the material conditions described above are fulfilled. It is for the Member State to show that the conditions are not fulfilled and that a possible refusal on that ground is justified. In its judgment in the Bellon case the Court held:
30. France has claimed that a procedure exists in France whereby a trader may request authorization to import products manufactured with additives, but that the French authorities have never received any request for authorization to add nitrate to cheese. Since the general prohibition against the addition of nitrate to cheese does not per se constitute an infringement of Article 30, France claims that the action should be dismissed, on the basis that the Commission has not shown an infringement of the Treaty provisions in the form of an actual rejection of an application.
31. In my view France is undoubtedly right in the basic premise of its claim.
32. There are valid reasons for that legal position. Quite apart from the fact that it is in accordance with the basic principle of Community law concerning additives — a general prohibition qualified by specific authorization (the approved list system) — the authorities of the Member States must be in the best position to assess whether the material conditions for approval are satisfied where there is an application from a trader accompanied by the available information on the technological need for the additive in question and the possible linked risks to health. On the one hand the trader is most familiar with the product in question, on the other he has a specific interest in being able to market it.
33. The question is, however, whether the obligation to approve an additive should arise solely when there is an application from a trader, or whether that obligation, as the Commission maintains, can also arise if the Commission approaches the Member State in question with a view to prevailing upon the Member State to authorize an additive in the manufacture of a specific product.
34. There would be advantages in accepting the Commission's view of the law. That would give the Commission the opportunity, if it was thought necessary, to ensure that there were no obstacles to trade in products lawfully produced in some Member States where the material conditions for the legality of such obstacles to trade were not satisfied. The effectiveness of the Treaty rules, which aim to ensure free movement of goods, would thereby be reinforced. It may be thought that there is particular reason to accept that view of the law in a situation such as the present involving an everyday foodstuff and an additive which has been known and used for many years.
35. There is however a question as to whether it would be proper at this point to alter the principles that can be derived from the case-law of the Court. It should not be possible for the Commission, in any event, simply on the basis of a finding that a specific additive is authorized in a product in one Member State to approach a Member State which does not allow such use in order to force that State, in reliance on Article 30 of the Treaty, to prove that the material conditions for the validity of the prohibition have been shown to exist. Such a course would tend towards the achievement of harmonization of the rules of the Member States which it is the Commission's task to implement by issuing general legal measures at Community level.
36. It might perhaps seem less reasonable on the facts to dismiss the case against France. Both in the prior administrative procedure and in the procedure before the Court France has expressed the view that a prohibition of the use of nitrate is in accordance with the material conditions which result from the case-law of the Court. It might be wondered whether France might not be said to have made the possibility of applying for authorization illusory by clearly and categorically expressing its negative attitude to cheese manufactured with added nitrate. In my opinion that circumstance is not, however, by itself sufficient for a finding against France, not least because France has already, in connection with its defence to the application and again at the hearing, declared itself willing to make a specific assessment of a given application in the light of existing scientific opinion.
37. It should be mentioned that no evidence has been submitted in the case against Italy or Greece to show that the authorities in those Member States have refused specific applications for authorization. The Greek Government has not claimed that the Greek authorities have never received any application for authorization. Such a submission was made by the Italian Government, but only at the hearing. I therefore take the view that it should be dismissed as being put forward too late. It should, furthermore, be pointed out that according to the information produced in the cases the Commission brought proceedings for infringement of the Treaty against Italy and Greece after it had received complaints from traders.
On that basis I suggest that the Court hold that:
1 Original language: Danish.
2 Greece maintains that the limit is in practice 15 mg. The Commission claims that Greece may not contend that a limit set by an express provision is departed from in pracúce. I see no reason to enter any further into that debate. In particular in the Greek case there was discussion over how far a tolerance threshold applies only to the natural occurrence of nitrate in cheese or also to added nitrate. The Greek Government claimed that it applies regardless of the fact that the provisions in question expressly state that the tolerance threshold only applies to substances that are naturally present. The Greek Government's argument is that it is not possible to determine the substance's origin by analysis. The Commission indicated that it is possible to check whether nitrate has been added to cheese by other methods and that the tolerance threshold must therefore be regarded as applying to natural residues of nitrate. I do not think it necessary to enter any further into that debate. The question to be decided by the Court in these cases is whether the three Member States are entitled to refuse to allow the importation of cheeses to which up to 50 mg of nitrate have been added in the manufacturing process. In this connection it is only of secondary importance whether the Member States allow, in principle, the importation of cheese to which certain lower quantities of nitrate have been added or completely prohibit the import of cheese to which nitrate has been added.
3 OJ, English Special Edition 1963-1964, p. 99.
4 Case C-42/90 Bellon [1990] ECR I-4863.
5 See also the judgments in Cases 88/79 Crunert [1980] ECR 1827 and 108/80 Kugdmann [1981] ECR 433.
6 OJ 1989 L 40, p. 27
7 See the judgments in Case 247/84 Motte [1985] ECR 3887, at paragraph 16, in Case 304/84 Muller [1986] ECR 1511, at paragraph 14, and Case C-42/90 Bellon, at paragraph 10, see footnote 3 above.
8 Luxembourg prohibits the use of nitrate in the manufacture of cheese in Luxembourg, but allows the markeung of cheese lawfully manufactured in other Member States using nitrate.
9 See the judgment in Case 8/74 Danonville [1974] ECR 837.
10 See, for example, Case 12/74 Commission v Germany [1975] ECR 181, at paragraph 14.
11 Judgments in Case 174/82 Sandoz [1983] ECR 2445, Case 247/84 Motte (see footnote 6), Case 304/84 Muller (see footnote 6); Case 178/84 Commission v Germany [1987] ECR 1227 (hereinafter Beer judgment, and Case C-42/90 Bellon (see footnote 3)).
12 See footnote 3.
13 In support of the need to add nitrate to certain cheeses the Commission referred to the fact that the Codex Alimentarius Committee of the FAO and WHO, which lays down standards for the manufacture of foodstuffs, recognizes the need for added nitrate in certain cheeses Ín quantities corresponding to 50 mg per kg of cheese. It appears from the documents that the addition of nitrate is required in the production of 15 out of a total of 34 cheeses for which standards have been laid down. The Commission also relied on a report, Review of the Italian position with respect to the ban on importation of cheeses prepared with the addition of nitrate drawn up at the request of the Commission by Professor R. Walker, Head of Division of Nutrition and Food Science, Department of Biochemistry, University of Surrey, England. In his report Professor Walker concludes that the use of nitrates is necessary from the technological point of view in order to prevent some cheeses being spoilt by anaerobic organisms. Finally the Commission submitted a report on nitrate and nitrite dated 19 October 1990 prepared by the Scientific Committee for Food. Paragraph 3.1.2 of that report states as follows:The Committee was informed that even under hygienic conditions some microbial contamination of milk cannot be totally avoided. If the cows have been fed silage, which is a major feed in some areas, this contamination includes bacteria such as Clostridium tyrobutyricum. Although of no health concern, these bacteria prevent the manufacturing of certain cheeses and some kind of measure is necessary to control the growth during the matūrinę of these cheeses. The information available to the Committee indicated that the addition of 150 mg nitrate (expressed as sodium salt) per litre of cheese milk is sufficient for this use and it will result in a content in the final product not exceeding 50 mg nitrate/kg.
14 See in particular: Case 174/82 Sandoz, paragraph 19, see footnote 10, and Advocate General Mancini's Opinion in the case, at paragraph 7; Case 247/84 Motte, at paragraph 24, see footnote 6, and Advocate General Mancini's Opinion in the case, at paragraph 8; Case 304/84 Muller, at paragraph 24, see footnote 6, and Advocate General Mancini's Opinion in the case, at paragraphs 4 and 5; Case 178/84 Commission v Germany, the Beer judgment, at paragraph 52, see footnote 10, and Advocate General Sir Gordon Slynn's Opinion in the case, in particular at pp. 1254-1255.
15 It should, moreover, be noted that the directive appears to require the Member States to comply immediately with the directive's general criteria in their national approval system. Article 12(1) of the directive thus provides that Member States shall take all measures necessary to ensure that food additives ... may be marketed only if they conform to the definitions and rules laid down in this Directive and the Annexes thereto.
16 See footnote 10. In paragraphs 51 and 52 the Court stated:It must be emphasized that mere reference to the fact that beer can be manufactured without additives if it is made from only the raw materials prescribed in the Federal Republic of Germany does not suffice to preclude the possibility that some additives may meet a technological need. Such an interpretation of the concept of technological need, which results in favouring national production methods, constitutes a disguised means of restricting trade between Member States. The concept of technological need must be assessed in the light of the raw materials utilized and bearing in mind the assessment made by the authorities of the Member State where the product was lawfully manufactured and marketed ...
17 The Scientific Committee for Food was set up by the Commission's Decision of 16 April 1974, OJ 1974 L 136, p. 1.
18 Under Article 9 of the Commission Decision relating to the institution of a Scientific Committee for Food (see footnote 16), where the members of the Committee are in unanimous agreement common conclusions are established. In the absence of unanimous agreement, however, the various positions are to be entered in a report drawn up under the responsibility of the representative of the Commission.
19 The ADI for nitrate was thus, in earlier investigations, including the investigations carried out by the Codex Alimentarius Committee, set at 5 mg per kg bodyweight. Here, however, on the basis of earlier research, a so-called no-effect level of 500 mg per kg bodyweight was operated with a safety factor of 100.
20 These conclusions are also supported by the Report drawn up by Professor Walker and submitted by the Commission, see footnote 12. It states inter alia: Nitrate is non-mutagenic in in-vitro assays and reproduction studies have not shown any specific adverse effects on reproductive function ... so it does not present a particular hazard during pregnancy. Levels of nitrate secreted into breast milk do not normally exceed maternal plasma levels so that the suckling infant is not exposed to significant levels by this route. (p. 18) ... the extent of conversion to nitrite may be higher in the neonatal infant. ... It is for these reasons that the ADI for nitrate is not applicable to neonatal infants. Since neonatal infams would not be consumers of the types of cheeses manufactured using nitrate and since maternal ingestion of such cheeses would not lead to detectable changes in nitrate levels in breast milk, there is no additional hazard to the neonatal infant from the use of nitrate in cheese ... (p. 18-19).
21 See the paragraphs of the Bellori case cited in point 7.
22 The Commission has explained its interpretation of the requirements laid down by the Court for authorization procedures in the Communication on the free movement of foodstuffs within the Community, paragraphs 36-40 (OJ 1989 C 271, p. 3).
23 See footnote 3.
24 This view is indirectly supported by the Court's judgment in the Bellon case, which involved an importer who had been prosecuted for having imported pastry products containing an additive without previously applying for authorization. Advocate General Mischo stated in his Opinion inter alia as follows: It is therefore clear that, if there is no authorization to use sorbic acid in panettoni, the French courts are entitled to apply the general prohibition laid down in French legislation and convict a defendant who has infringed that prohibition. (paragraph 24) The operative part of the Court's judgment does not contain an express formulation of the problem, but the above-cited conclusion in the judgment can, in my view, be interpreted as supporting this view.