1. By order of 24 May 2001, received at the Court on 23 July 2001, the Tribunale civile di Bologna (Civil District Court, Bologna) referred to the Court for a preliminary ruling under Article 234 EC a question on the interpretation of Council Directive 92/46/EEC of 16 June 1992 laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk-based products (OJ 1992 L 268, p. 1), as amended by Council Directive 94/71/EC of 13 December 1994 (OJ 1994 L 368, p. 33, " Directive 92/46" ), of Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (OJ 1979 L 33, p. 1), as amended by Directive 97/4/EC of the European Parliament and of the Council of 27 January 1997 (OJ 1997 L 43, p. 21, " Directive 79/112" ), and of Council Directive 89/396/EEC of 14 June 1989 on indications or marks identifying the lot to which a foodstuff belongs (OJ 1989 L 186, p. 21).
2. That question was raised in proceedings between Granarolo SpA ( " Granarolo" ), a company established in Bologna (Italy) and the Comune di Bologna (Municipality of Bologna) concerning the imposition by the latter of a fine on that company for failing to comply with the Italian legislation requiring a use-by date of four days for the conservation of high-temperature pasteurised milk. Legal background The Community legislation
3. Under Article 5 of Directive 92/46, the Member States are to ensure that heat-treated drinking milk is not placed on the market unless it meets certain conditions, set out inter alia in Annex C, Chapter I, to that directive.
4. Chapter I(A)(4)(a) of Annex C to Directive 92/46 provides: " Pasteurised milk must: ... (ii) show a negative reaction to the phosphatase test and a positive reaction to the peroxidase test. However, the production of pasteurised milk which shows a negative reaction to the peroxidase test is authorised, provided that the milk is labelled as " high-temperature pasteurised" " .
5. According to Chapter II(C), second indent, of Annex C to Directive 92/46, microbiological criteria applicable, under conditions managed and controlled by the operator or manager of the establishment, to the use-by date may be established where necessary in accordance with the procedure laid down in Article 31 of that directive.
6. Chapter IV(B)(3) and (4) of Annex C to Directive 92/46 lays down certain requirements as regards labelling of milk products. Without prejudice to the provisions of Directive 79/112/EEC, the labelling must clearly show for inspection purposes the nature of any heat treatment applied at the end of the manufacturing process, and, for milk-based products in which growth of micro-organisms can occur, the use-by or minimum durability date.
7. Under Article 3(1)(4) of Directive 79/112 indication of certain particulars is compulsory on the labelling of foodstuffs, inter alia the date of minimum durability, or, in the case of foodstuffs which are highly perishable from a microbiological point of view, the use-by date.
8. Article 9(1) to (4) provides that the date of minimum durability of a foodstuff is the date until which the foodstuff retains its specific properties when properly stored. That date must be preceded by the words " best before ..." or " best before end ..." . If need be, those particulars are to be followed by a description of the storage conditions which must be observed if the product is to keep for the specified period.
9. Article 9a, inserted by Council Directive 89/395/EEC of 14 June 1989 amending Directive 79/112/EEC (OJ 1989 L 186, p. 17), provides that, in the case of foodstuffs which, from the microbiological point of view, are highly perishable and are therefore likely after a short period to constitute an immediate danger to human health, the date of minimum durability is to be replaced by the use-by date. That date is to be preceded by the words " use by" . Those particulars are to be followed by a description of the storage conditions which must be observed. That date is to consist of the day, the month and, possibly, the year, in that order and in uncoded form.
10. Under Article 14 of Directive 79/112: " Member States shall refrain from laying down requirements more detailed than those already contained in Articles 3 to 11 concerning the manner in which the particulars provided for in Article 3 and Article 4(2) are to be shown."
11. Article 15 of Directive 79/112 provides: " 1. Member States may not forbid trade in foodstuffs which comply with the rules laid down in this directive by the application of non-harmonised national provisions governing the labelling and presentation of certain foodstuffs or of foodstuffs in general. 2. Paragraph 1 shall not apply to non-harmonised national provisions justified on grounds of: ─ protection of public health, ─ prevention of fraud, unless such provisions are liable to impede the application of the definitions and rules laid down by this directive, ─ protection of industrial and commercial property rights, indications of provenance, registered designations of origin and prevention of unfair competition. " The national legislation
12. Article 1 of Law 169 entitled " Disciplina del trattamento e della commercializzazione del latte alimentare vaccino" (law laying down rules on the treatment and marketing of cow ' s milk for human consumption), of 3 May 1989 (GURI No 180 of 11 May 1989, p. 1996, " Law 169/89" ), defines the properties of milk intended for direct human consumption. In particular, it must have undergone at least one permitted heat treatment or an authorised treatment with equivalent effect in a milk treatment establishment.
13. Article 2 of Law 169/89 provides that the types of heat treatment permitted for milk intended for direct human consumption are: " (a) pasteurisation: heat treatment in continuous flow for at least 15 seconds at a temperature lower than boiling point but higher than 72 degrees centigrade or for a time and at a temperature ensuring an equivalent amount of heat, so as to ensure the destruction of all pathogenic micro-organisms and a significant proportion of the saprophyte microbial flora, with limited alteration of chemical, physical and organoleptic properties; (b) sterilisation: heat treatment which guarantees the destruction of all micro-organisms present in milk or definitively prevents their proliferation. "
14. Under Article 2 of Law 169/89, other treatments may be authorised by decree of the Minister for Health by agreement with the Minister for Agriculture and Forestry, in line with, inter alia, technological development or Community legislation.
15. Article 3 of Law 169/89 defines the term " pasteurised milk" as follows: " Milk treated by pasteurisation which shows, on consumption, (a) a negative reaction to the alkaline phosphatase test; (b) an undenatured soluble protein serum content of less than 11% of total protein. "
16. The definition of " fresh pasteurised milk" is set out in Article 4 of Law 169/89, according to which: " " Fresh pasteurised milk" means milk which arrives in a raw state at the treatment plant and undergoes a single heat treatment within 48 hours of milking and shows, on consumption (a) a negative reaction to the alkaline phosphatase test, (b) an undenaturated soluble protein serum content of not less than 14% of total protein, and (c) a positive reaction to the peroxidase test. "
17. Under Article 4 of Law 169/89, fresh pasteurised milk can be defined as " high quality fresh pasteurised milk" if it shows, on consumption, an undenaturated soluble protein serum content of not less than 15.5% of total protein, and if it was obtained from stables or collection centres (cooperatives and milk consortiums) and meets certain health standards and content requirements set by an ad hoc ministerial decree.
18. The third paragraph of Article 5 of Law 169/89, headed " General provisions on milk treated by pasteurisation" , provides: " The name of the type of milk, as defined in Articles 3 and 4, must appear in full and be visible on the same part of the packaging as that on which the durability date is given indicated by the words " use by" followed by the date expressed in terms of day, month and year. The durability date may not exceed four days after treatment. "
19. The provisions of Article 5 of the Decreto del Presidente della Repubblica No 54, Regolamento recante attuazione delle direttive 92/46/EEC e 92/47/EEC in materia di produzione e immissione sul mercato di latte e di prodotti a base di latte (Regulation implementing Directives 92/46/EEC and 92/47/EEC concerning the production and placing on the market of milk and milk-based products) of 14 January 1997 (ordinary supplement to GURI No 59, of 12 March 1997, p. 1200, " Decree 54/97" ), concerning the production, processing, labelling, storage and transport of heat-treated milk, are comparable in content to those of Article 5 of Directive 92/46. That decree reproduces in Annex C the provisions of Chapter I(A)(4)(a) to (d) of Annex C to Directive 92/46 and those of Chapter IV(B) of that Annex.
20. Decreto legislativo No 109, Attuazione delle direttive 89/395/EEC e 89/396/EEC concernenti l ' etichettatura, la presentazione e la pubblicità dei prodotti alimentari (legislative decree implementing Directives 89/395/EEC and 89/396/EEC relating to labelling, presentation and advertising of foodstuffs), of 27 January 1992 (ordinary supplement to GURI No 39, of 17 February 1992, p. 501, " legislative decree 109/92" ), implements Directives 89/395 and 89/396 in Italian law.
21. Article 3(1)(d) of legislative decree 109/92 reproduces Article 3(1)(4) of Directive 79/112 verbatim.
22. Article 10 of legislative decree 109/92, which implements Articles 9 and 9a of Directive 79/112, provides: " 1. The date of minimum durability of a foodstuff shall be the date until which the foodstuff retains its specific properties when properly stored; it shall be preceded by the words " best before" followed by the date or a reference to where on the packaging it is to be found. 2. The use-by date of a foodstuff shall be the date until which the foodstuff may be consumed; it shall be indicated by the words " use by" followed by the date or a reference to where on the packaging it is to be found. 3. The date shall consist of the day, the month and the year, in that order and in uncoded form. " The main proceedings and the question referred
23. In 1999 Granarolo marketed in Italy high-temperature pasteurised milk produced in Germany.
24. The Comune di Bologna imposed an administrative fine of ITL 2 167 000 on Granarolo for marking on the packaging of that milk a use-by date of more than the four days after the date of treatment required by Article 5 of Law 169/89.
25. Granarolo appealed against that fine before the Tribunale civile di Bologna. In that appeal it submitted that Article 5 of Law 169/89 was contrary to Community law and, in particular, to Directives 92/46, 89/395 and 89/396.
26. Granarolo submitted that high-temperature pasteurised milk was produced by a special method of pasteurisation called the Falling Stream Heater system (a steam infusion procedure) which was more powerful than traditional pasteurisation and results in milk with a longer shelf-life but with organoleptic and nutritional qualities comparable to those of fresh pasteurised milk.
27. Granarolo stated that the concept of high-temperature pasteurised milk was introduced in Italy by Decree 54/97 which implemented Directive 92/46. It argued that the application to this type of milk of the short date provided for by the third paragraph of Article 5 of Law 169/89 undermined the effect of Decree 54/97 and, as a result, of Directive 92/46. It submitted that the use-by date should be fixed by the producer according to the actual length of time the product keeps on the basis of Article 10 of legislative decree 109/92. That decree implemented Directives 89/395 and 89/396 in Italian law.
28. Taking the view that the fine imposed on Granarolo by the Municipality of Bologna would have to be cancelled if Directives 92/46, 89/395 and 89/396 were interpreted as Granarolo argued, the Tribunale civile di Bologna decided to stay proceedings and refer the following question to the Court of Justice for a preliminary ruling: " Is application of the combined provisions of Council Directive 92/46/EEC of 16 June 1992 laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk-based products (implemented in Italy by Decree 54/97 of 14 January 1997) and Directives 89/395/EEC and 89/396/EEC, which concern the labelling, presentation and advertising of foodstuffs (implemented in Italy by legislative decree 109/92 of 27 January 1992) limited by the content of a piece of national legislation (in particular Article 5(3), in relation to Article 3, of Law 169/89 of 3 May 1989), with the result that (according to the interpretation which has been given thereto in the present case) a " best before" date of four days after preparation would apply to milk pasteurised at high temperature (a type of milk contemplated and governed solely by Directive 92/46 and Decree 54/97)? " Preliminary observation
29. The Italian Government submits that the interpretation of national law in the order for reference is incorrect on certain points. According to that government Law 169/89 is not applicable to high-temperature pasteurised milk.
30. It is to be remembered in this regard that it is not for the Court of Justice to rule on the interpretation and applicability of provisions of national law or to establish the relevant facts for the settlement of the dispute in the main proceedings.
31. It is for the Court to take account, under the division of jurisdiction between the Community courts and the national courts, of the factual and legislative context, as described in the order for reference, in which the question put to it is set (Case C-475/99 Ambulanz Glöckner [2001] ECR I-8089, paragraph 10).
32. The question referred for a preliminary ruling must therefore be considered in the legislative context defined and interpreted by the Tribunale civile di Bologna in its order for reference. The question referred for a preliminary ruling
33. By its question the referring court seeks essentially to know whether Community law and, in particular, the provisions of Directives 92/46, 79/112 and 89/396 preclude a national provision such as Article 5 of Law 169/89 which lays down a use-by date of four days after preparation for milk pasteurised at high temperature.
34. The Court has consistently held that, in interpreting a provision of Community law, it is necessary to consider not only its wording but also the context in which it occurs and the objects of the rules of which it forms part (Case C-223/98 Adidas [1999] ECR I-7081, paragraph 23; Case C-301/98 KVS International [2000] ECR I-3583, paragraph 21; Case C-156/98 Germany v Commission [2000] ECR I-6857, paragraph 50; Case C-191/99 Kvaerner [2001] ECR I-4447, paragraph 30, and Case C-491/01 British American Tobacco and Imperial Tobacco (Investments) [2002] ECR I-11453, paragraph 203).
35. Directive 89/396 lays down, as its title suggests, rules on indications or marks identifying the lot to which a foodstuff belongs. Under Article 5 of that directive, when the date of minimum durability or use-by date appears on the label, no indication identifying the lot need appear on the foodstuff. That provision is not in any way intended to fix the use-by date of a foodstuff. Moreover, the directive contains no other provision concerning, directly or indirectly, the establishment of such a date for milk products.
36. Directive 79/112, according to Article 1 thereof, concerns the labelling of foodstuffs to be delivered as such to the ultimate consumer and certain aspects relating to the presentation and advertising thereof. That directive lays down methods of labelling, the list of compulsory particulars and, where appropriate, the way in which those particulars must be worded.
37. As the Advocate General pointed out in point 42 of his Opinion, Directive 79/112 lays down rules of a procedural nature concerning the compulsory indications to be given on the labelling of foodstuffs and lays down no substantive rules on the content of such indications. Although Article 3(1) of that directive provides that the labelling must include the date of minimum durability of those foodstuffs or, in the case of highly perishable foodstuffs, the use-by date and the wording which must be used to indicate it, it contains no rule whereby the date of minimum durability or the use-by date of such foodstuffs may be directly or indirectly determined.
38. Finally, Directive 92/46, according to Article 1 thereof, lays down health rules for the production and placing on the market of raw milk, heat-treated drinking milk, milk for the manufacture of milk-based products and milk-based products intended for human consumption.
39. It is also clear from the second and fifth recitals in the preamble to Directive 92/46 that those rules were laid down at Community level in order to ensure the rational development of the milk sector and to create the conditions for the gradual establishment of the internal market.
40. Under Chapter II of Directive 92/46, headed " Rules governing Community production" , the products covered by that directive, in other words, raw milk, heat-treated milk and milk -based products, must meet the conditions laid down in Annexes A to C thereto in order to be used in the manufacture of other products and, in the case of heat-treated milk, in order to be placed on the market.
41. Thus, Annex A to Directive 92/46 lays down requirements relating to the acceptance of raw milk at milk treatment and/or processing establishments. The provisions of Annex B to that directive lay down general conditions for approval of such treatment establishments and processing establishments and hygiene standards for premises, equipment and staff of such establishments. Annex C, Chapter I, lays down requirements for the manufacture of heat-treated milk and milk-based products. In that connection, it must be pointed out that Chapter I(A)(4)(a)(ii) of Annex C to Directive 92/46 authorises the production of high-temperature pasteurised milk. Chapter II of Annex C sets out the microbiological criteria for milk-based products and drinking milk. Chapters III and IV of that Annex lay down rules on packaging, wrapping and labelling of the products covered by Directive 92/46. Chapter V of that Annex sets out storage and transport requirements for those products. Finally, under Chapter VI of Annex C, the establishments concerned are subject to health checks carried out by the competent authority.
42. As the Advocate General observed in point 36 of his Opinion, Directive 92/46 governs all the stages in the milk production process, from animal health to the transport of products to various sales outlets.
43. It must be held that, although it lays down very detailed rules as regards the different stages of the production and marketing of milk, Directive 92/46 is not intended to fix the date of minimum durability or the use-by date of the products it covers. Apart from a provision contained in Chapter II(C) of Annex C to that directive, according to which microbiological criteria applicable to the use-by date may be adopted at Community level, the directive contains no provision on that subject. Nor can it be inferred from the directive that it is for the producers to fix those dates.
44. Against that background, it must be concluded that, in the absence of provisions adopted at Community level, the determination of the use-by date for milk products is generally the responsibility of each Member State acting in accordance with the rules set out in Articles 9 and 9a of Directive 79/112.
45. Although the Member States are generally responsible for fixing the use-by date of products covered by Directive 92/46, they must refrain from taking any measures liable seriously to compromise achievement of the result prescribed by the directive.
46. As is clear from the preamble to and the general structure of the provisions of Directive 92/46, it is intended inter alia to facilitate the marketing and free movement of milk products covered by it.
47. Achievement of the result prescribed by Directive 92/46 might be seriously compromised if a Member State fixed a use-by date for one of those milk products which was liable to constitute a serious obstacle to the marketing of that product in that State.
48. In fact, Article 5 of Law 169/89 fixed the same use-by date for high-temperature pasteurised milk as for fresh pasteurised milk, namely four days after preparation of the product. However, the advantage of marketing high-temperature pasteurised milk is that it has a long shelf-life, longer than the four days after preparation of the product provided for by Article 5 of Law 169/89 and significantly longer than that of fresh pasteurised milk.
49. Fixing such a use-by date appears liable to constitute a serious obstacle to the marketing and free movement of that type of milk in Italy and thus seriously compromise achievement of the result prescribed by Directive 92/46.
50. It must therefore be held that Directive 92/46 precludes national legislation such as that at issue in the main proceedings which fixes the use-by date for high-temperature pasteurised milk in such a way that it cannot be longer than four days after preparation of the product in question.
51. In any event, national legislation such as that at issue in the main proceedings constitutes a restriction on the free movement of goods within the meaning of Article 28 EC.
52. Although it is true that the determination of the use-by date for milk falls within the remit of the Member States ' health policy, the Italian Government put forward no argument to establish that the use-by date fixed by the national legislation was necessary to ensure the protection of public health or safeguard some other public interest.
53. The use-by date of four days laid down by Law 169/89 appears in any event to be disproportionate to the objective of protecting public health as it has not been established on the basis of objective evidence that high-temperature pasteurised milk has as short a shelf-life as fresh pasteurised milk.
54. Accordingly, the answer to the question referred must be that Directive 92/46 and Articles 28 EC and 30 EC preclude national legislation such as that at issue in the main proceedings, which requires a use-by date of four days after preparation for high-temperature pasteurised milk.