C-97/83

JUDGMENT OF 6. 6. 1984 — CASE 97/83

organization of the market in milk meaning of Article 30 of the EEC products or through harmonization Treaty. of relevant national legislation, the 4. National legislation which Member States may prescribe the standards which products intended for (a) does not allow active coliform human consumption must satisfy in bacteria to be present in a pas- their own territories. However, the teurized milk product — the national provisions in question cannot presence of such bacteria con- be exempt from the application of stituting a direct indication that Article 30 et seq. of the Treaty. the product may be a source of real danger to human health — 3. The prohibition in Article 30 of and measures having equivalent effect (b) is intended to prevent such a applies to all trading rules enacted by product from containing at the the Member States which are capable time of its consumption non- of hindering, directly or indirectly, pathogenic micro-organisms in a actually or potentially, intra-Com- quantity which may present a risk munity trade. to the health of the most sensitive consumers and to that end fixes National legislation prohibiting the the maximum number of such marketing of goods lawfully produced micro-organisms that may be and marketed in the exporting present on the date of sale of the Member State on the ground that product on the basis of its deterio- they do not satisfy the microbiological ration in the time between its sale requirements laid down in the im- and consumption porting Member State constitutes a measure equivalent in effect to a complies with the requirements of quantitative restriction within the Article 36 of the EEC Treaty.

composed of: Lord M a c k e n z i e Stuart, President, Y. Galmot, President of C h a m b e r , O . D u e , U. Everling and C. Kakouris, Judges,

Advocate General : P . V e r L o r e n van T h e m a a t Registrar: H . A. Rühl, Principal Administrator

gives the following

JUDGMENT

Facts and Issues

The facts of the case, the course of Article 34 (2) of the Melkbesluit provides the procedure and the observations that the description "pasteurized" may submitted under Article 20 of the be used only if products: Protocol on the Statute of the Court of Justice of the EEC may be summarized "(a) have undergone anti-microbial heat as follows: treatment or other treatment having the same anti-microbial effect; and

whipping cream, in which case that The Netherlands supervisory authority number must not exceed 200 000; took samples in a number of areas of the product which Melkunie was holding for sale. Analyses carried out on five (c) no phosphatase must be present consignments between February and July unless the product has undergone, 1980 revealed that on or immediately instead of anti-microbial heat before the latest date for sale stated on treatment, other treatment having the packaging of the product in question the same anti-microbial effect." 9 000 000 active micro-organisms per millilitre were present in the first two consignments, 18 000 000 in the third, 90 000 000 in the fourth and 82 000 in Pasteurized products must bear the the fifth, and active coliform bacteria description "pasteurized" on their were present in the third and fourth packaging (Melkbesluit, Article 34 (6)) consignments. and must also be kept and carried by the vendors at a temperature not exceeding 10° C (Melkbesluit, Article 43 (1)). In view of the results of those analyses, Melkunie was prosecuted before the Requirements regarding the durability of Economische Politierechter [magistrate pasteurized products are contained in the dealing with commercial offences] for Algemeen Aanduidingenbesluit [General holding in stock goods unfit for human Description of Goods Order] (Waren­ consumption in contravention of the provisions of the Melkbesluit 1974 wet) of 10 September 1981 (Staatsblad (Staatsblad, 699). N o 621). Article 4 (3) (c) read together with Article 10 of that order provides that pre-packed foods and drinks must bear the words "Best before . . ." By a judgment of 16 April 1981, followed by the relevant date. If that Melkunie was acquitted of the charges. date depends on the goods' being kept in a particular way, this must be stated. On appeal by the Openbaar Ministerie [Public Prosecutor's Department], the Offences against those provisions are Gerechtshof [Regional Court of Appeal], punishable under the Wet op de Amsterdam, ordered ' Melkunie, by Economische Delicten [Law on Com­ judgment of 7 May 1982, to pay five mercial Offences] of 22 June 1950 HFL 4 000 fines for "five offences (Staatsblad N o 258). committed by a corporate body against a provision adopted pursuant to Article 16 of the Warenwet".

In accordance with Article 20 of the (b) the maximum number of active Protocol on the Statute of the Court of micro-organisms must not ex- Justice, written observations were sub- ceed 50 000 per millilitre save in mitted by Melkunie, represented by the case of whipping cream, in R.A.A. Duk of the Hague Bar; the which case that number must not Netherlands Government, represented by exceed 200 000; I. Verkade, Secretary General at the Ministry of Foreign Affairs, acting as be regarded as measures having an Agent; the Danish Government, effect equivalent to quantitative represented by Laurids Mikaelsen, Legal restrictions on imports within the Adviser at the Ministry of Foreign meaning of Article 30 of the EEC Affairs, acting as Agent; and the Treaty if they are applied in Commission of the European Com- conjunction with the provisions munities, represented by its Legal referred to in part 6 of this judgment Adviser, R. Casper Fischer, acting as to goods imported from another Agent. Member State of the European Communities? Upon hearing the report of the Judge- Rapporteur and the views of the Advocate General, the Court decided, in 2. If Question 1 is answered in the accordance with Article 21 of the Statute affirmative, is the adoption of the and Article 45 of the Rules of Procedure, requirements referred to in that to conduct measures of inquiry. question and their application to goods imported from another Member State of the European By letter dated 15 December 1983, the Communities none the less justified Registrar of the Court asked the under Article 36 of the EEC Treaty Commission to communicate before 20 on one of the grounds mentioned in January 1984 the text of the German that article and in particular on legislation applicable to the products in grounds of the protection of the question. 'health of humans'?" On 19 January 1984 the Commission produced the text of that legislation. In part 6 of its judgment the Hoge Raad In the observations attached to the states that, although contravention of documents it produced, the Commission the requirements laid down by the states that it cannot say with any Melkbesluit 1974 is an economic offence certainty which requirements of the within the meaning of the Wet op de German legislation were applicable to Economische Delicten of 22 June 1950, the products in question. The reason for the prohibitions in question were made this is that there is insufficient evidence pursuant to the Keuringsverordening in the file concerning in particular the [Inspection Regulations] of the munici- composition of the products in question

In the Commission's view it is difficult to In Melkunie's view, it is clear from both distinguish between the qualitative re­ the Commission's official views, ex­ quirements and the health requirements pressed in the Cpmmunication concern­ laid down by the German legislation. ing the consequences of the judgment Considering, however, that, in view of given by the Court of Justice on 20 the evidence on file and the judgment February 1979 in Case 120/78 (Rewe- making the reference, the preliminary Zentral AG ν Bundesmonopolverwaltung questions concern only the protection of für Branntwein [1979] ECR 649, Official public health, the Commission confines Journal C 256, 3. 10. 1980), and from its commentary to the relevant that decision itself, confirmed by the requirements of the German legislation. judgments of 26 June 1980 in Case The extracts given to the Court are 788/79 (Gilli and Andres, [1980] ECR taken from Part . A of "Lebens­ 2071), of 16 December 1980 in Case mittelrecht" [Food Law], by Walter 27/80 (Fietje, [1980] ECR 3839) and of Zipfel. 19 February 1981 in Case 130/80 (Kelderman, [1981] ECR 527), that, even if the national legislation under which the prosecution is brought is a reasonable In accordance with Article 54 of the measure not immediately caught by the Rules of Procedure the date for the prohibition contained in Article 30 of the opening of the oral procedure was fixed Treaty, no criminal sanction should be for the end of the period in which the imposed if. the product in question questions asked by the Court were to be satisfies the conditions laid down by the answered. legislation of the country of its origin.

After stating that the purpose of pas- "Application of the provisions referred to teurizing milk and milk products is to in this question to products imported kill micro-organisms present in the from another Member State amounts to untreated product, Melkunie goes on to a measure having an effect equivalent to distinguish between pathogenic micro- a quantitative restriction on imports organisms, the very presence of which within the meaning of Article 30 of the makes the use of the products harmful to EEC Treaty if the products satisfy the health, and "ordinary" bacteria which do conditions applying to them in that other not make the product unfit for Member State and if those conditions are consumption unless their growth, which equivalent to the provisions in question. is dependent in particular on the If that is not the case, it must be temperature at which the product is kept, established that it was not possible to exceeds a specific limit fixed by Article take sufficient account of the interests 34 (3) of the Melkbesluit within a period protected by those provisions by other indicated by the latest date for sale. In less stringent measures, such as a the second case, it is necessary therefore provision requiring products to bear to distinguish between the inevitable, labels showing the differences between gradual change in the product, which has them and products complying with those no effect on human health, and its provisions." permanent deterioration.

JUDGMENT OF 6. 6. 1984 — CASE 97/83

It also observed that the number of 1. The national legislation micro-organisms present in a product depends not on the effectiveness of the pasteurization process, which a con- siderable number of micro-organisms always survive so long as the product is After setting out the terms of Article 34 not sterilized, but on the conditions in (3) of the Melkbesluit, the Netherlands which it is kept. In Melkunie's view it Government observes that the purpose of follows from these points, first, that the the local regulations adopted pursuant to efficacy of the pasteurization process Article 6 of the "Warenwet, which are the itself offers no guarantee for human same in every municipality, is to health, and, secondly, that, if on the "exclude" from the market, and thus to latest date for sale the number of micro- prohibit the sale of, products which, if organisms exceeds the maximum per- used as intended, are harmful to human mitted by law, this will mainly be due to health, of poor quality or not in ac- the fact that the period between the date cordance with the conditions laid down of production and the date for sale was by law or regulation. too long and did not take into account the conditions (especially temperature) in which the product was or must be kept. The Netherlands Government points out first that, if the requirements laid down by those provisions are not met, the products are not immediately withdrawn Melkunie suggests that the answer to the from the market; the initial response of Hoge Raad's second question should be the authorities, especially where the as follows: product does not contain any

pathological micro-organisms and shows organisms specified in Article 34 (3) of no organoleptic deviation from the the Melkbesluit was fixed on the basis of norm, is merely to issue a warning or two criteria: serve a cautionary summons so that production conditions or the treatment of the product are improved. In the case in point, sale of the product was never prohibited; summonses were served only The first was the number of micro- after a warning had been given. organisms which may reasonably be expected to exist in a product which has been manufactured, carried and stored prudently and the threshold beyond The second observation of the which there is a risk that the product will Netherlands Government is that, if the become contaminated by pathogenic requirements laid down by Article 34 (3) micro-organisms. of the Melkbesluit are not met, this does not make the sale or consumption of the product in question impossible, but it represents a potential danger to human health and indicates that hygiene was The second was that after the latest date inadequate or not as good as it could be for sale has passed the consumer should during the making of the product or be allowed a reasonable period (about thereafter. The purpose of Article 34 (3) two days) to consume a product before of the Melkbesluit is to prevent the its organoleptic qualities deteriorate. As consumer from being offered products the rate at which micro-organisms which may be either a threat to his multiply when the product is kept in a health or not of the quality (as regards refrigerator is known, the number of colour, smell, taste) which he is entitled such organisms existing on the product's to expect of a food product. latest date for sale was fixed at 50 000, a figure which guarantees that the product will be in a reasonable state of conser- vation for the following two days. The decisive test in this regard is whether a product has been, or may very quickly become, contaminated by pathogenic bacteria, which will be indicated by the presence of coliform By requiring the product's latest date for bacteria. The deterioration of the sale to be shown it is possible to product depends on the number of determine not only the efficacy of the micro-organisms it contains and is due to pasteurization process but also whether the effect of the substances they secrete. carriage and storage has affected the product in such a way as to make it unacceptable.

According to the Netherlands Govern- ment, the point at issue in both of the questions submitted by the Hoge Raad is In the first place, the absence of simply whether the provisions in Community harmonization leaves Mem- question, which apply to domestic and ber States a wide discretion and entitles imported products alike, are compatible them to lay down standards which with Articles 30 and 36 of the EEC products intended for human Treaty. consumption must satisfy, subject to fines or a prohibition of sale for failure to comply. The freedom of action of the Member States is particularly justified Referring to the judgment of 11 July where, as may be seen in this case, 1974 in Case 8/74 (Dassonville [1974] scientific investigation does not make it ECR 837), the Netherlands Government possible to determine with sufficient states that, although the provisions in accuracy the bacteriological thresholds question may constitute obstacles to beyond which health may be endangered imports, such obstacles are permissible and consequently the strict rules of hy- first under Article 36 of the Treaty if giene which must be observed through- they are justified on grounds of, in out the production and marketing of a particular, the protection of public health product. and secondly by virtue of the "reason- ableness rule" implied in the Court's interpretation of Article 30 of the Treaty if the obstacles are justified by con- The Danish Government observes, siderations of public interest including, secondly, that, in view of Articles 30 and for example, the protection of con- 36 of the Treaty and the decisions of the sumers. Court, the Netherlands legislation in question can be justified on a number of grounds. Although in its written observations it concentrates mainly on the public health aspects, the Netherlands Government is not explicitly relying on one or the other As regards first Article 36 of the Treaty, possible grounds of justification afforded the Danish Government states that the by Articles 30 and 36 of the Treaty. exception concerning the protection of

Accordingly, the Danish Government submits that in view of the general The Commission considers that, in order interests of consumers it is legitimate that to ascertain whether the provisions in Member States should be able by question are compatible with Articles 30 legislation to exclude from the market and 36 of the Treaty, it is necessary to food products which do not merit that determine whether their purpose is solely description. In its view, provisions of that to ensure fair trading or whether they nature should apply both to domestic are partly or solely dictated by the and imported products in order to avoid interests of public health. a lowering of hygiene standards achieved after perhaps many years of effort by the authorities and the producers.

The fact that the Hoge Raad cites only Article 16 of the Warenwet as the legal basis of the Melkbesluit seems to indicate The Danish Government observes sec- that, like the Gerechtshof and the ondly that, in view of the requirements Openbaar Ministerie, the Hoge Raad which the national legislation in question considers that the sole purpose of the satisfies, rules requiring no more than Melkbesluit is to protect public health.

JUDGMENT OF 6. 6. 1984 — CASE 97/83

On the same point, the Commission "The application by a Member State to notes that, in the judgment referred to goods lawfully produced and marketed the Hoge Raad, the Gerechtshof held in another Member State of legislation that "the fact that other EEC countries providing that certain milk products may may set lower requirements . . . does not not be marketed unless they are pas- alter matters . . . consumer habits, par- teurized and meet specific microb- ticularly as regards the quantity in which iological standards constitutes a measure the product is consumed, are relevant to having an effect equivalent to a the requirements to be imposed as quantitative restriction on imports within regards the number of micro-organisms the meaning of Article 30 of the EEC present, and those habits may vary from Treaty." country to country".

Although this argument has quite rightly The second question been accepted by the Court as regards the incorporation into food products of certain additives such as preservatives The Commission's first observation ís and vitamins (judgment of 5 February that the microbiological aspects of the 1981 in Case 53/80 Kaasfabriek Eyssen, production and marketing of milk and cited above, and of 14 July 1983 in Case milk products have not been regulated by 174/82 Sandoz [1983] ECR 2445), it is the Community legislature either within untenable in this case once it is accepted, the market organization for milk as the Gerechtshof does, that the number

MELKUNIE

JUDGMENT OF 6. 6. 1984 — CASE 97/83

without at the same time analysing the protection of public health in the product so as to determine its micro- importing Member State, and biologial condition and the danger it presented to public health.

(ii) That it was not possible to protect In the Commission's view, the testing that interest sufficiently by other method adopted shows, if not that the measures less restrictive to imports latest date for sale is inappropriate, at of the products in question, in least that the method fails to take particular by appropriate co- account of the fact that the micro- operation between the competent biological condition of a pasteurized authorities of the Member States milk product, properly kept and carried, concerned. inevitably deteriorates with the passage of time and much more quickly than sterilized products in which, because they are heated to 100° C, all the micro- organisms are killed. That is why Whether and the extent to which it has legislation in some countries requires been shown that the microbiological pasteurized products to meet the pres- standards applicable to the marketing of cribed microbiological standards at the pasteurized milk products and referred end of the pasteurization process. to in the first question are justified on grounds of the protection of public health and that their application to The application of such a measure in its imported products accords with the entirety to imported products cannot be principles set out above is in this case for removed from the ambit of Article 30 of the national court to decide." the Treaty by invoking Article 36. The Commission therefore suggests that the second question should be answered as follows :

3 Article 34 (3) of the Melkbesluit provides that on the latest date for sale pasteurized milk products must satisfy inter alia the following requirements:

"(a) active coliform bacteria must not be detectable in one millilitre;

(b) the number of active micro-organisms must not exceed 50 000 per millilitre save in the case of whipping cream, in which case that number must not exceed 200 000; . . . " .

4 Analyses carried out by the Netherlands supervisory authority of five consignments imported from the Federal Republic of Germany for marketing in the Netherlands revealed that on or immediately before the latest date for sale stated on the packaging of the product in question 9 000 000 active micro-organisms per millilitre were present in the first two consignments,

JUDGMENT OF 6. 6. 1984 — CASE 97/83

18 000 000 in the third, 90 000 000 in the fourth and 82 000 in the fifth, and active coliform bacteria were present in the third and fourth consignments.

7 Although the Court has no jurisdiction in proceedings under Article 177 of the EEC Treaty to rule on the question whether provisions of national

MELKUNIE

legislation are compatible with the Treaty, it may provide the national court with all such criteria for the interpretation of Community law which may enable it to answer that question.

8 Accordingly, it must be assumed that the Hoge Raad wishes to know:

whether national legislation prohibiting the marketing of pasteurized products lawfully produced and marketed in the exporting Member State on the ground that they do not satisfy the microbiological requirements of the importing Member State constitutes a measure having an effect equivalent to a quantitative restriction on imports within the meaning of Article 30 and, if so,

in what circumstances does Article 36 of the Treaty allow such a restriction on imports on the grounds of the protection of health and life of humans.

The second question

12 According to a consistent line of decisions of the Court, it follows from Article 36 that a national measure which has, or may have, a restrictive effect on trade is compatible with the Treaty only in so far as it is necessary for the purpose of effectively protecting human life and health. The proviso in Article 36 cannot therefore apply where human life and health can be protected just as effectively by measures less restrictive of intra-Community trade.

1 3 In this connection, Melkunie points out, first, that the product in question complied with the requirements of the legislation of the exporting Member State and that that legislation provides the same safeguards as the legislation of the importing Member States. Consequently, the requisite cooperation between Member State ought to induce the importing Member State to require no more than that the imported products should comply with the standards of the exporting Member State. Secondly, it contends that legislation of the Netherlands type cannot be justified under Article 36 since it goes beyond what is required by a strict concern to safeguard public health.

1 4 As far as Melkunie's first argument is concerned, it should be pointed out that, whilst it is true, as the Court has held many times, for example in its judgment of 8 February 1983 in Case 124/81, Commission of the European Communities ν United Kingdom, [1983] ECR 203, that cooperation between the authorities of the Member States makes it possible to facilitate and simplify frontier checks whilst not precluding the authorities of the importing Member State from satisfying themselves that the goods imported comply with the requirements of that State's health legislation, none the less such cooperation cannot impair the right of each individual Member State to enact and apply its own legislation to protect public health. Such legislation

16 As regards the second requirement, laying down the maximum permissible number of active non-pathogenic micro-organisms, Melkunie and the Commission first point out that, in the present state of scientific knowledge, it is not possible to establish the maximum quantity of such micro-organisms that man may absorb every day without serious risk. They go on to state that it is only where the concentration of such micro-organisms reaches one or two million per millilitre of the product in question — much higher than the maximum level of 50 000 stipulated by the Melkbesluit — that there is possibly a risk to human health. Finally, they consider that to stipulate the maximum number of non-pathogenic micro-organisms that may be present on the latest date for sale of a pasteurized product is excessively strict and that it would be sufficient to apply a requirement of that kind at the end of the pasteurization process.

17 It must first be noted that, according to the documents before the Court, the Member States which lay down a maximum limit for non-pathogenic micro- organisms stipulate levels of the same order of magnitude as the figure of 50 000 laid down by the Melkbesluit, even though that requirement is applied at different marketing stages.

JUDGMENT OF 6. 6. 1984 — CASE 97/83

18 Secondly, the data available at the present stage of scientific research do not make it possible to determine with certainty the precise number of non- pathogenic micro-organisms above which a pasteurized milk product becomes a source of danger to human health. In the absence of harmon- ization in this field, it is for the. Member States to determine, with due regard to the requirements of the free movement of goods, the level at which they wish to ensure that human life and health are protected. In those circumstances, national legislation seeking to ensure that at the time of consumption the milk product in question does not contain micro-organisms in a quantity which may constitute a risk merely to the health of some, particularly sensitive consumers, must be considered compatible with the requirements of Article 36.

complies with the requirements of Article 36 of the EEC Treaty.

Costs

21 The costs incurred by the Danish Government, the Netherlands Government and the Commission of the European Communities, which have submitted observations to the Court, are not recoverable. As these proceedings are, in so far as the parties to the main proceedings are concerned, in the nature of a step in the proceedings pending before the national court, the decision on costs is a matter for that court.

On those grounds,

T H E C O U R T (Fifth Chamber),

in answer to the questions referred to it by the Hoge Raad by judgment of 10 May 1983, hereby rules:

Delivered in open court in L u x e m b o u r g on 6 J u n e 1984.

For the Registrar H . A. Rühl Y. G a l m o t Principal Administrator President of the Fifth Chamber

OPINION OF MR ADVOCATE GENERAL VERLOREN VAN THEMAAT D E L I V E R E D O N 11 A P R I L 1984 1

Mr President, Netherlands legislation applicable to milk Members of the Court, and milk products which is at issue in this case. With this reference for a preliminary ruling made by the Hoge Raad [Supreme Court] in the criminal proceedings brought against the firm to which I shall 1. T h e r e l e v a n t l e g i s l a t i o n on refer as Melkunie the Court is once milk a n d milk p r o d u c t s again confronted with the question how far provisions of Netherlands food legislation may conflict with Articles 30 Netherlands food legislation is mainly and 36 of the EEC Treaty. Before based on the Warenwet [Law on Goods] discussing the facts I shall first review the of 28 December 1935 laying down

1 — Translated from the Dutch.