C-95/89

COMMISSION v ITALY

OPINION OF ADVOCATE GENERAL GULMANN delivered on 8 April 1992 *

Mr President, The three Member States have contended Members of the Court, that the applications should be dismissed.

1. These three cases have been brought by 2. An account of the legislation in the three the Commission under Article 169 of the Member States is contained in the Reports EEC Treaty and concern the ban, in Italy, for the Hearing. It can be summarized as fol- Greece and France, on the importation and lows: marketing of cheeses to which nitrate has been added at the manufacturing stage.

— in all three Member States there is a pro- hibition against manufacturing foodstuffs with additives and marketing such food- In all three cases the Commission claims stuffs unless the additives in question are that, by prohibiting the importation of expressly authorized; cheeses lawfully produced and marketed in other Member States to which nitrates have been added during the manufacturing pro- cess within limits recognized by interna- tional scientific opinion as acceptable (50 mg — none of the three Member States has per kg), the Member States in question have authorized the use of nitrate in the man- failed to fulfil their obligations under Article ufacture of cheese and accordingly the 30 of the EEC Treaty. marketing of cheese to which nitrates have been added is prohibited in the three Member States;

The Kingdom of Spain intervened in the case — according to information from the Mem- against France in support of the Commis- ber States, that prohibition is only sion. applied to imported cheeses if the nitrate content exceeds a certain tolerance threshold corresponding to what the * Original language: Danish. Member States consider to be natural res-

'According to its preamble, the directive is merely the first stage in the approximation of national laws in that field. At this stage, therefore, Member States are not obliged to The harmonization directives on the subject authorize the use of all the substances listed in the annex to the directive. However, their freedom to determine their own rules con- cerning the addition of preservatives to food- stuffs may be exercised only subject to the twofold condition that no preservative not listed in the annex to the directive may be

. .' (paragraph 9). 4 tive 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 Let me say right away that the condition to substance in question but is not obliged to the effect that nitrate may not be completely do so. Most recently, in its judgment of prohibited does not give rise to difficulty in the present cases since the three Member States permit the addition of nitrate to meat

sis. The Commission indicated that it is possible t o check on preservatives. Complete harmonization in whether nitrate has been added to cheese by other methods and that the tolerance threshold must therefore be regarded this area has not yet been accomplished. The as applying to natural residues of nitrate. I do not think it necessary to enter any further into that Council has adopted Council Directive debate. The question to be decided by the Court in these 89/107/EEC of 21 December 1988 on the cases is whether the three Member States are entitled to refuse to allow the importation of cheeses to which up to approximation of the laws of the Member 50 mg of nitrate have been added in the manufacturing pro-

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States concerning food additives authorized Do the national rules constitute an obstacle for use in foodstuffs intended for human to trade within the meaning of Article 30? consumption, 5 but the directive is merely a framework directive which requires direc- tives to be drawn up with lists of the autho- rized additives, the foodstuffs in which those additives may be used and the conditions for their use. 5. The Commission has stated that eight other Member States permit nitrate to be added in the manufacture of certain cheeses. 7 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 The position is that until that harmonization per kg cheese is permitted. is achieved, the Member States are entitled to lay down their own rules as regards nitrate as an additive in foodstuffs.

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OPINION OF MR GULMANN — CASE C-95/89

other Member States. France further pointed 'It must be borne in mind that, as the Court out that imports from the Netherlands to has consistently held ... in so far as there are France increased even for cheeses which, uncertainties in the present state of scientific under Netherlands manufacturing rules, may research, it is for the Member States, in the be manufactured with added nitrate, and absence of harmonization, to decide what claimed that that shows that the prohibition degree of protection of the health and life of at issue does not constitute a barrier to trade. humans they intend to assure, having regard, The Court's case-law shows clearly that that however, for the requirements of the free circumstance cannot be regarded as rele- movement of goods within the Community. vant. 9

Are the national rules justified on public health grounds under Article 36? It is also clear from the Court's case-law ... that in those circumstances Community Uw does not preclude the adoption by the Mem- ber States of legisUtion whereby the use of additives is subjected to prior authorization granted by a measure of general application for specific additives, in respect of all prod- 7. The crucial question in these cases is ucts, for certain products only or for certain therefore whether the prohibitions against uses. Such legislation meets a genuine need of the marketing of cheese with added nitrate is health policy, namely that of restricting the justified with regard to the protection of uncontrolled consumption of food additives. human health under Article 36.

Muller, and Case 178/84, Commission v Ger- the addition of nitrate within specifically many, ... the Court inferred from the princi- defined limits does not present a risk to ple of proportionality underlying the last sen- health. tence of Article 36 of the Treaty that prohibitions on the marketing of products containing additives authorized in the Mem- ber State of production but prohibited in the Member State of importation must be restricted to what is actually necessary to secure the protection of public health. The Court also concluded that the use of a spe- The three cases before the Court do not cific additive which is authorized in another therefore appear to give rise to much diffi- Member State must be authorized in the case culty at first sight. However, on closer exam- of a product imported from that Member ination it would appear that there are at least State where, in view, on the one hand, of the three issues in the cases which require con- findings of international scientific research, sideration by the Court because its previous and in particular of the work of the Commu- case-law contains no clear answers on these nity's Scientific Committee for Food, the points. Codex Alimentarius Committee of the Food and Agriculture Organization of the United Nations (FAO) and the World Health Orga- nization, and, on the other hand, of the eat- ing habits prevailing in the importing Mem- ber State, the additive in question does not present a risk to public health and meets a real need, especially a technological one.' Does nitrate meet a real need, especially a (emphasis added) (Paragraphs 11-14). technological one?

use silage for a large part of the year and technological need, it is not necessary to where cheeses of that type are manufac- examine whether there are alternative and tured. 12 less harmful methods, because the sole issue is whether the additive is suitable to meet the technological need in question. In the alter- native the Commission claims that the meth- ods to which the Member States refer are not sufficiently effective. 10. The defendant Member States have not contested the fact that there may be a tech- nological 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 11. The Court of Justice has not previously claimed that the use of nitrate is not techno- decided whether Member States can refuse to logically necessary because there are other, allow the marketing of a product by refer- less harmful, methods which can prevent ence to the fact that the additive used is not Mate blowing'. necessary to meet a technological need because the desired objective can be realized by other means.

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— in its case-law the Court has therefore Community law recognizes a general health concentrated on whether there existed a policy objective that the use of additives in real need which the additive in question foodstuffs should be limited, as far as possi- would meet, and did not give its attention ble. That is evident inter alia from the fact to whether it was possible to replace an that it is possible to introduce a general pro- additive by other methods; hibition on additives and to refuse to allow the importation of superfluous additives, even though they cannot properly be described as a health risk. It is consonant — the Court is prepared to go a consider- with that objective to promote the use of able way towards recognizing the desire alternative methods. Directive 89/107 thus to promote a certain quality in a given expressly recognizes that in assessing the product as a 'real need'. technological need for a particular additive regard must be had to possible alternative means. Annex II to the directive lays down the 'general criteria for the use of food addi- tives' to be applied when including additives It may, moreover, be noted that in no judg- in a list, see Article 2(3) of the directive. ment has the Court accepted a prohibition Paragraph 1 in the annex provides that 'food on importation on the sole ground that there additives can be approved provided that: — was no technological need and that, for obvi- there can be demonstrated a reasonable tech- ous reasons, in its judgments most emphasis nological need and the purpose cannot be is placed on the question of risks to health. achieved by other means which are econom- ically and technologically practicable'. u

On this point, therefore, I would suggest that the Court uphold the Commission in its principal claims, namely that it is sufficient If the said broad construction of the require- that it can be shown that in the production ment that a technological need be met is of certain cheeses there is a technological accepted, it is probable that in many cases need which the addition of nitrate is a suit- the Member States will seek to justify import able means of meeting. prohibitions by reference to the fact that in their view alternative means are available. It can hardly be doubted that an import prohi- bition on that basis will be met with protests from the Member State of production, which will contend that it has already carried out 15. Since the defendant Member States, as an examination of the adequacy of possible mentioned above, have not disputed that the alternative methods when it approved the addition of nitrate could meet the technolog- additive. The result will be a number of ical need that has been found to exist, in my actions in which the Court will be faced with view it should be held that the Member a choice between numerous possible meth- States' prohibition cannot be justified on the ods of production. In this connection it is basis that there is no technological need for significant that the question of alternative the addition of nitrate to certain specified methods is only significant where it has cheeses. already been decided that the additive in question is capable of meeting a specified technological need and does not present a risk to health, and it is important that typi- cally these will be cases concerning technically-involved questions where often 16. For the sake of completeness, I should, no solutions are to be found in international however, mention that from the information scientific research as regards which methods available in the cases, as far as I am able to should be considered, on the one hand, to assess it, there is no basis for considering that present the least risk to health and, on the the technological need demonstrated can be other, adequate in the light of the specific wholly met by the use of other additives or application. other production methods.

— better milk hygiene will never be able to 15 — See footnote 10. In paragraphs 51 and 52 the Court stated: 'It must be emphasized that mere reference to the fact that prevent completely the presence of bacte- beer can be manufactured without additives if it is made from only the raw materials prescribed in the Federal ria in milk. Republic of Germany does not suffice to preclude the pos- sibility 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 The Member States do not dispute that some light of the raw materials utilized and bearing in mind the bacteria are resistant to lysozyme, or that assessment made by the authorities of the Member State where the product was lawfully manufactured and mar- bactofugation is not per se an adequate alter- keted ..."

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19. Comprehensive material has been sub- mitted to the Court containing research and Nitrate does not present a direct risk to evaluation of the possible harmful effects on health of any appreciable significance. The health of nitrate, including various scientific possible risk to health linked to nitrate reports, extracts from the literature on the intake is due to its reduction to nitrite either subject etc. I do not believe it necessary to before ingestion or in vivo. Nitrite in certain 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 16 — The Scientific Committee for Food was set up by the Com- the question of health risks must be judged mission's Decision of 16 April 1974, OJ 1974 L 136, p. 1. 17 — Under Article 9 of the Commission Decision relating to the on the basis of international scientific institution of a Scientific Committee for Food (see footnote research and in addition has specified that 16), where the members of the Committee are in unani- mous agreement common conclusions are established. In particular weight should be given to the con- the absence of unanimous agreement, however, the various positions are to be entered in a report drawn up under the clusions drawn by the Community's Scien- responsibility of the representative of the Commission.

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quantities does involve a direct risk to health. The use of nitrate as a food additive contrib- Further, there may be a possible connection utes a relatively small amount to total intake between added nitrate quantities and the for- because the predominant proportion origi- mation of volatile nitrosamines, which are nates from the 'natural nitrate content' in cancer-forming. vegetables and drinking water. Nitrate is used as an additive in meat products, cheese, milk and fish products. As far as the addition of nitrate to cheese is concerned the Com- mittee concludes in Paragraph 3.1.2 of the The main scientific problem is to establish an Report that: 'acceptable daily intake' (hereinafter 'ADI'), that is to say the quantity that may be ingested daily without harm to the human organism.

The Committee did not receive information concerning the nitrate intake for the whole of the Community, but regards it as clear Although a correlation between the addition that nitrate intake in all the areas investigated of nitrate and the formation of volatile is 'generally well within the ADIs, except in N-nitroso compounds in cheese has not been areas where levels of nitrate in vegetables are demonstrated, recent studies suggest a possi- high and levels in drinking water exceed ble correlation between nitrate and the con- Community standards'. tent of apparent total N-nitroso compounds. ... For this reason the Committee recom- mends that the use of nitrate should be 18 — The ADI for nitrate was thus, in earlier investigations, restricted to 150 mg in milk for cheese man- including the investigations carried out by the Codex Ali- ufacture until the toxicological significance mentarius Committee, set at 5 mg per kg bodyweight. Here, however, on the basis of earlier research, a so-called of these results can be clarified. For control no-effect level of 500 mg per kg bodyweight was operated with a safety factor of 100. purposes it is also recommended that a max-

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imum limit for residual nitrate is fixed at should not be used as an additive in infant 50 mg per kg in the finished cheese.' (empha- foods.' 1 9 sis added)

21. The defendant Member States have dis- puted the proposition that in assessing the risk to health presented by nitrate the start- 22. To summarize, the question whether ing point to be taken should be a generally nitrate, judged on the basis of international established ADI, because no account is scientific research, presents a risk to public thereby taken of specially sensitive groups of health can accordingly be answered as fol- persons such as old people, pregnant women lows: and children. Especially as far as infants are concerned, the Member States have claimed that as a result of the higher P H content of their stomachs nitrate is to a large extent reduced to nitrite. — a daily intake of up to 5 mg of nitrate per kg bodyweight does not present a risk to health; and

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23. As is clear from the above-cited judg- 25. The Commission contests the accuracy ment in the Bellon case, in assessing the risk of much of that information but otherwise to health of an additive account must also be employs a different approach in its argu- taken of eating habits prevailing in the ments on this point from that of the Member importing Member State. States. The Commission thus takes cheese- eating habits as its basis. In the Commis- sion's view it is crucial that even where it is assumed that all cheese contains the maxi- mum 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 24. The arguments put forward by the nitrate concentration in cheese to which Member States in that respect concentrate nitrate is added is, as a rule, well under mainly on showing that the established ADI 50 mg per kg, the Commission states that to is exceeded as a result of their respective allow nitrate to be added to cheese will population's eating habits in respect of all probably result in a rise of only 0.5 mg in foodstuffs, including water, containing daily intake. nitrate.

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The significance of other sources of nitrate 28. In view of the foregoing I believe that to intake must primarily be taken into account refuse to authorize the importation of when the acceptable maximum quantities for cheeses in respect of which there is a techno- individual products are being laid down. logical need for the addition of nitrate and That the Scientific Committee for Food in which contain a residual nitrate concentra- fact made its evaluation bearing that in mind tion not exceeding that which international is clear from the above-cited remarks in the scientific research has declared to be accept- report to the effect that a nitrate content of able from a health point of view is not justi- up to 50 mg per kg of cheese is regarded as fied on health grounds and such refusal is acceptable from a toxicological point of view thus contrary to Article 30 of the Treaty. because 'potential nitrate intake from that source ¿5 regarded as insignificant in relation to the established A D I ' (emphasis added).

Is the obligation of the Member States to give authorization conditional on submis- sion of an application by a trader?

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. . has been added. However, in the The case-law of the Court can only be Member State of importation, the marketing understood as meaning that a Member State of that foodstuff must be authorized under a is not bound automatically to put an additive procedure which is readily accessible to man- on its approved list simply because it fulfils a ufacturers and traders and which can be technological need and is not a risk to completed within a reasonable period, where health. 23 Any infringement of Article 30 of the addition of the substance in question the Treaty will only occur in connection meets a genuine need — in particular a tech- with an actual decision on an application nological need — and represents no danger submitted for authorization to use an addi- to public health. It is for the competent tive. national authorities to show in each case, in the light of national eating habits and with due regard to the results of international sci- entific research, that their rules are necessary in order to give effective protection to the interests referred to in Article 36 of the Trea- ty.' (emphasis added)

Since the general prohibition against been prosecuted for having imported pastry products con- taining an additive without previously applying for autho- the addition of nitrate to cheese does not per rization. Advocate General Mischo stated in his Opinion inter alia as follows: se constitute an infringement of Article 30, 'It is therefore clear that, if there is no authorization to use France claims that the action should be dis- sorbic acid in "panettoni", the French courts are entitled to apply the general prohibition laid down in French legisla- missed, on the basis that the Commission has tion and convict a defendant who has infringed that prohi- bition.' (paragraph 24) not shown an infringement of the Treaty The operative part of the Court's judgment does not con- provisions in the form of an actual rejection tain an express formulation of the problem, but the above- cited conclusion in the judgment can, in my view, be inter- of an application. preted as supporting this view.

33. The question is, however, whether the 35. There is however a question as to obligation to approve an additive should whether it would be proper at this point to arise solely when there is an application from alter the principles that can be derived from a trader, or whether that obligation, as the the case-law of the Court. It should not be Commission maintains, can also arise if the possible for the Commission, in any event, Commission approaches the Member State simply on the basis of a finding that a spe- in question with a view to prevailing upon cific additive is authorized in a product in the Member State to authorize an additive in one Member State to approach a Member the manufacture of a specific product. 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 'har- monization' of the rules of the Member 34. There would be advantages in accepting States which it is the Commission's task to the Commission's view of the law. That implement by issuing general legal measures would give the Commission the opportunity, at Community level. 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 Nor is there ground for thinking that the aim to ensure free movement of goods, effectiveness of the rules in the Treaty on free would thereby be reinforced. It may be movement of goods cannot be sufficiently thought that there is particular reason to ensured by the trader's being able to apply accept that view of the law in a situation for authorization and by the possibilities such as the present involving an everyday which, under the case-law of the Court, foodstuff and an additive which has been must be available for judicial review of known and used for many years. refusal of a request. It is clear that in this connection the Commission will have impor- tant responsibilities, within the framework of its usual powers under Article 169 of the Treaty, to ensure that the Member States administer the authorization system in accor- That a Member State, in a case where an dance with the requirements which follow approach comes from the Commission and from the case-law of the Court.

I therefore take the view that the necessary and logical consequence of the legal princi- ples applicable in practice laid down by the Court is that the case against France must be dismissed, and I shall therefore suggest to the Court that it should find against the Com- Accordingly I consider that the Court mission. should adhere to its view that a general pro- hibition is compatible with Community law, whereas a rejection of a specific application by a trader would be in breach thereof if the material conditions for the legality of a rejec- tion were not fulfilled. 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 applica- tion for authorization. Such a submission was made by the Italian Government, but 36. It might perhaps seem less reasonable on only at the hearing. I therefore take the view the facts to dismiss the case against France. that it should be dismissed as being put for- Both in the prior administrative procedure ward too late. It should, furthermore, be and in the procedure before the Court pointed out that according to the informa- France has expressed the view that a prohibi- tion produced in the cases the Commission tion of the use of nitrate is in accordance brought proceedings for infringement of the with the material conditions which result Treaty against Italy and Greece after it had from the case-law of the Court. It might be received complaints from traders. wondered whether France might not be said to have made the possibility of applying for authorization illusory by clearly and categor- ically expressing its negative attitude to cheese manufactured with added nitrate. In my opinion that circumstance is not, how- ever, by itself sufficient for a finding against I shall therefore suggest to the Court that it France, not least because France has already, should find against Italy and Greece in in connection with its defence to the applica- accordance with the Commission's claims.

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