Opinion of Advocate General Gulmann delivered on 8 April 1992

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.