C-121/00

HAHN

OPINION OF ADVOCATE GENERAL GEELHOED delivered on 13 December 2001 1

I — Introduction I I — Legal background

A — Community Imu

2. The Directive sets out the essential requirements for the hygienic handling of fresh and processed fishery products at all stages of production, storage and trans- port. 3 These essential requirements are in 1. In this reference for a preliminary ruling part laid down in some detail and in part the Court is asked to answer the question comprise general rules requiring further whether a national ban on the presence of a elaboration. pathogenic micro-organism — Listeria monocytogenes — in smoked fishery products for human consumption is com- patible with Community law. The Bezirks- gericht Innere Stadt Wien (Inner City of Vienna District Council) has requested an interpretation of Council Directive 91/493/EEC of 22 July 1991 laying down 3. According to Article 3(1 )(d) of the the health conditions for the production Directive, fishery products caught in their and the placing on the market of fishery natural environment may only be placed on products ('the Directive'). 2The response to the market if they have undergone a health this question requires an examination of check in accordance with Chapter V of the the compatibility of such 'zero tolerance' Annex. The second part of that chapter lays with Articles 28 and 30 EC regarding the down special conditions for, inter alia, free movement of goods. microbiological analyses. As regards these microbiological analyses, Chapter V, sec-

1 — Original language: Dutch. 2 —OJ 1991 L 268, p. 15. 3 — See the fourth recital in the preamble.

4. Article 6(1) of the Directive requires the Member States to ensure that persons responsible for establishments take all necessary measures to observe the health rules, in particular with regard to the identification of critical points and the establishment and implementation of methods for monitoring and checking such critical points. Under Article 6(3) of the Directive, rules for the application of those principles are to be established in accord- ance with the procedure laid down in Article 15 of the Directive. 7. Point 6 of Chapter I of the Annex provides for the establishment of a list of the hazards and risk control measures. Point 6(a) of Chapter I states that 'hazard' should be understood to mean 'a potential 5. On the basis in particular of Article 6(3) to cause harm to health and is anything of the Directive, the Commission adopted covered by the hygiene objectives of Direc- on 20 May 1994 Decision 94/356/EC lay- tive 91/493/EEC'. More specifically it can ing down detailed rules for the application concern 'unacceptable contamination' of a of Council Directive 91/493/EEC as regards biological nature, including by micro-or- own health checks on fishery products ('the ganisms, and 'unacceptable' survival or Decision'). 4 multiplication of pathogenic micro-organ- isms. According to point 6(b) of Chapter I the measures regarding risk control cover measures to prevent a hazard, to eliminate it or to reduce its impact or occurrence to an 'acceptable level'. Furthermore, one measure may be used to control a variety 6. Under Article 2(1) of the Decision a of risks. To illustrate this it is stated that 'critical point' within the meaning of 'pasteurisation or controlled heat treatment may provide sufficient assurance of reduc- tion of the level of both salmonella and 4 — OJ 1994 L 156, p. 50. listeria'.

10. Paragraph 8a of the LMG provides that foodstuffs and consumer products are 12. The court which referred the question harmful to health if they are capable of has described the facts and background of endangering or damaging health. the main action as follows.

5 — BGBl. No 86/1975, as amended. 6 — BGBl. No 260/1997.

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13. W. Hahn or the representatives of the examination. The foodstuffs were declared company Nordsee GmbH are suspected of unfit and criminal proceedings were insti- negligently placing on the market food- gated. stuffs harmful to human health. Between the end of 1998 and the beginning of 1999, in particular, a series of samples was taken at the headquarters and various branches of Nordsee GmbH, or in supermarkets to which the company had delivered fishery products. The samples were taken partly in routine checks by food inspectors and partly as a result of complaints from affected parties following symptoms of 15. The referring court explains that on food poisoning. The foodstuffs which were 9 February 1998 the competent Hygiene later rejected as unfit consisted of smoked Committee adopted a method for determin- fish products (choice smoked salmon, ing the presence of Listeria monocytogenes: smoked salmon from Denmark and the in a sample with a stable original weight of North Sea, both sliced and in rolls). 25 grams, of products which either had not been further treated but stabilised by other means — for instance, by smoking, the addition of salt or vacuum packaging — or which were uncooked and ready to eat or which had been heat-treated, a negative finding can only be expressed as 'not detectable in 25 g' (zero tolerance). When there is evidence of Listeria monocyto- genes, the food must be classified as harmful to health.

19. Written observations were submitted by Mr Hahn, the Staatsanwaltschaft Wien (Vienna Public Prosecutor's Office), the Republic of Austria and the Commission. 18. The national court considers the ques- On 23 October 2001 an oral hearing took tion of whether a legal provision may lay place, at which Mr Hahn and the Commis- down a policy of zero tolerance for Listeria sion explained their positions. monocytogenes, or whether in accordance with the Directive the risk must be reduced to an 'acceptable level', to be decisive in the criminal proceedings. Consequently, the Bezirksgericht Innere Stadt Wien made an order on 21 March 2000, which was received at the Registry of the Court of Justice on 30 March 2000, requesting a preliminary ruling on the following ques- tion: IV — Analysis

A — Introduction 'Is Council Directive 91/493/EEC of 22 July 1991 laying down the health con- ditions for the production and placing on the market of fishery products, which has been implemented in national law by the 20. The heart of the question posed by the Verordnung der Bundesministerin für Bezirksgericht is whether Community law Frauenangelegenheiten und Verbraucher- allows a Member State to maintain zero schutz über Hygienebestimmungen für das tolerance for Listeria monocytogenes in Inverkehrbringen von Fischerzeugnissen fishery products that have not been chemi- ("Fischhygieneverordnung", BGBl. cally preserved, in particular smoked No 260/1997), to be interpreted generally salmon.

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22. As will be made apparent below, I am in agreement with the views expressed by the Republic of Austria and the Commis- sion. In my opinion, the application of zero tolerance for Listeria monocytogenes in smoked fishery products at issue in these 24. By implication, therefore, the Staats- proceedings is within the scope of the anwaltschaft asks the Court to declare that Directive and complies with the Treaty it has no jurisdiction to rule, since the main rules regarding the free movement of proceedings do not concern a question of goods. law. In my view this argument fails. It is sufficient to point out that the Bezirks- gericht has stated that the question as to the legitimacy under Community law of zero tolerance for Listeria monocytogenes is a determining factor for the criminal pro- ceedings concerned, regardless of the legal character of the provision in question B — Admissibility according to national law. Should zero tolerance not be permissible under Com- munity law, the defendant cannot in this case be held criminally liable, according to the national court. Consequently, the inter- 23. First, however, we must consider the pretation of Community law requested is argument of the Staatsanwaltschaft Wien linked to the subject-matter of the main that Austrian law contains no rule 'on the proceedings and relates to a genuine dis- basis of which fishery products that have pute. The Court is therefore competent to not been chemically preserved (in particu- answer the question referred. 7 lar smoked salmon) are subject to zero tolerance in event of contamination of these foodstuffs with Listeria monocyto- 7 —See for instance Case C-340/99 TNT Traco [2001] genes'. According to the Staatsanwalt- ECR 1-4109, paragraphs 30 and 31).

C — Consideration of zero tolerance in does not provide for complete harmon- the light of secondary Community law isation with regard to limit values to combat the contamination of smoked fishery products with Listeria monocyto- genes. That is shown by the absence of such specific values in the Community legis- lation and by the wording and scheme of the Directive. 25. Mr Hahn argues that the position of the Austrian authorities that the presence of Listeria monocytogenes in 25 grams would automatically endanger health is in contra- diction with the wording of the Directive and the provisions implementing the Decision. If Listeria monocytogenes should not be present at all in fishery products, that would undoubtedly have been expressed by incorporating zero tolerance in those rules. The two standards adopted 27. The Directive itself contains no by the European legislature however, microbiological criteria, but provides in according to Mr Hahn, are on the one Chapter V, part II, point 4, that the hand an 'unacceptable' degree and on the Community legislature is competent to other hand (particularly in connection with establish microbiological criteria in accord- Listeria monocytogenes) reduction to an ance with the comitology procedure laid 'acceptable level'. 8 It can thus be con- down in Article 15. To date this procedure cluded that the mere presence of Listeria has only been used to adopt microbiologi- monocytogenes cannot lead to the with- cal criteria for cooked crustaceans and drawal from the market of certain fishery molluscan shellfish. 9Point 1 (pathogens) products. Furthermore, the Austrian meas- of the Annex to Decision 93/51 provides ure is based on a fiction in terms of that the limit for 'salmonella spp.' is that it foodstuffs law, the presence of Listeria is to be 'absent in 25 g'. In addition, point 1 monocytogenes in 25 grams being equated states that 'pathogens and toxins thereof with danger to public health. which are to be sought according to the risk evaluation must not be present in quantities such as to affect the health of consumers'. The Commission has stated in this regard that Listeria monocytogenes undoubtedly belongs to these two groups. However, these criteria apply only to the relatively restricted group of cooked crustaceans and molluscan shellfish and not to smoked 26. I consider rather that the Commission salmon or other smoked fishery products. and the Austrian Government are correct in observing that secondary Community law 9 — Commission Decision 93/51/EEC of 15 December 1992 on the microbiological criteria applicable to the production of cooked crustaceans and molluscan shellfish (OJ 1993 L 13, 8 — See in particular point 6(a) and (b) of Chapter I of the p. 11). This decision is based on Chapter IV, section IV, Annex to the Decision, as cited in point 7 of this Opinion. point 7(c) of the Annex to the Directive.

28. Moreover, the Community legislature 30. Furthermore, Mr Hahn's argument has to date laid down specific microbi- that 'acceptable' for the purposes of ological limits only for Listeria monocyto- point 6(a) and (b) of Chapter I of the genes in certain milk-based products. For Annex to the Decision can in no way be cheese and hard cheese the criterion is interpreted as covering zero tolerance is in 'absent in 25 g', for other milk products my view manifestly unsustainable. On the 'absent in 1 g'. 10 basis of these provisions the Member States may require establishments to limit hazards and risks to 'acceptable' levels by estab- lishing microbiological criteria. The degree to which contamination, infection or haz- ard might be acceptable is related to the maximum amount permissible, beyond which the product is no longer considered fit to eat. The provisions cited do not in fact provide for standardisation on the basis of a minimum value. The Decision does not therefore preclude Member States from 29. The Community legislature is thus considering only zero tolerance to be competent to establish specific limits, acceptable for certain risks. including zero tolerance, relating to the presence of Listeria monocytogenes, but for smoked fishery products such specific implementing measures have not yet been adopted. This is also apparent from the fact that in a recent recommendation relating to foodstuffs controls the Commission expressly stated that specific microbiologi- cal standards for smoked fish are still lacking at Community level. 1 1The Com- mission has also let it be known in its written observations that in the meantime, on the basis of the 23 September 1999 Opinion of the Scientific Committee on Veterinary Measures Relating to Public Health on Listeria monocytogenes which I shall discuss presently, it is preparing a 31. In the absence of exhaustive Commu- draft decision that is partly based on the nity rules the Member States may continue Directive and in which specific microbi- to apply national law, although in doing so ological standards for smoked fish will be they must comply with the general provi- considered. sions of the EC Treaty. A regulation such as that concerned in the main proceedings must therefore also be examined in the light 10 —Annex C, Chapter II(A)(1), to Council Directive 92/46/EEC of 16 June 1992 laying down the health rules of Articles 28 and 30 EC. 12 for the production and placing on the market of raw milk, heat-treated milk and milk-based products (OJ 1992 L 268, p. 1). 11 — See point 6.1 of the Commission Recommendation of 12 — See for example to that effect Case 304/84 Claude Muller 18 April 2001 concerning a coordinated programme for and Others [1986] ECR 1511, paragraph 14, and more the official control of foodstuffs for 2001 (OJ 2001 L 120, recently Case C-67/97 Bluhme [1998] ECR I-8033, p. 41). paragraphs 11 to 13.

33. Since Community harmonisation of limit values for Listeria monocytogenes in 35. The Court has clarified this basic fishery products is not yet complete, the principle, in particular when reviewing question arises as to whether such a national legislation on additives. This case- measure is justified under Article 30 EC law has been extensively referred to by the on the ground of protection of human parties in their written observations and in health. the oral procedure. 17 The Austrian Gov-

13 — Case 8/74 Dassonwille |1974| ECR 837, paragraph 5. Sec 15 —See for example Case C-347/89 Eurim-Pharm [1991] also Case 97/83 Melkunie [1984] ECR 2367, paragraph 11. ECR I-1747, paragraphs 26 and 27, and Case C-205/89 Commission v Greece [1991] ECR I-1361, paragraph 8. 14 — It is not known whether the imported products were lawfully marketed in another Member State. As far as can 16 — Case 174/82 Sandoz [1983] ECR 2445, paragraph 18. be deduced from the order for reference the issue did not 17 — For example Joined Cases C-13/91 and C-113/91 Debus arise in the main proceedings. [1992] ECR I-3617, paragraphs 13 to 18.

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absorbed by the consumer, in particular in is contained in the documents before the the form of residues in foodstuffs, can Court. The referring court states that neither be predicted nor controlled the Listeria monocytogenes is a pathogen that Court decided that 'strict measures to causes infection in humans and animals reduce the risks faced by the consumer leading to listeriosis. This disease affects were justified'. Thus Member States may predominantly children, older people and adopt regulations that vary from one immunocompromised individuals. It fre­ country to another according to the quently develops into septicaemia (blood- national conditions, and they may permit poisoning), or meningitis (an acute inflam­ different levels of the same pesticide in mation of the tissue covering the brain and different foodstuffs.22 spinal cord also known as cerebro-spinal meningitis). In pregnant women, it can lead to premature labour and miscarriage.

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consequences for certain susceptible with Listeria monocytogenes in order to groups, is confirmed in a joint report that protect public health is therefore beyond was drawn up in July 2000 at the request of question. However, the parties differ in the FAO and the World Health Organi- their opinions with regard to the compet- sation. 25 ence of a Member State to totally exclude the presence of Listeria monocytogenes in the foodstuffs in question.

45. Mr Hahn does not deny that the pre- 43. The need for measures to prevent the cautionary principle is gaining importance contamination of smoked fishery products within the Community, but he considers that it is clear that Listeria monocytogenes represents a danger to health only for a 25 — See the Report of the Joint FAO/WHO Expert Consul- limited section of the population, and that tation on Risk Assessment of Microbiological Hazards in even for this group there are doubts as Foods, report of ad hoc expert consultations which took place in Rome from 17 to 21 July 2000 regards the existence of risk below the level (http://ww.fao.org/WAICENT/FAOINFO/ECONOMIC/ ESN/pagerisk/riskpage.htm; http://www.who.int/fsf/ of 100 Listeria monocytogenes per gram. mbriskassess/index.ntm). Whilst these susceptible groups need to be 26 — See the Recommendation of the Commission of 18 April 2001 (cited in footnote 11), paragraph 6.1. aware of their higher sensitivity to certain

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47. In my opinion the proportionality prin- ciple is not a static concept, but should rather be considered in the light of the 49. Moreover, considered objectively, the intended objective. I conclude from the Austrian measure is not impracticable. written observations of the Austrian Gov- ernment and the Commission that the measure at issue aims primarily to protect 2 7 — See paragraph 3 7 of this Opinion.

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V — Conclusion

54. Accordingly I propose that the Court reply to the question referred by the Bezirksgericht Innere Stadt Wien as follows:

(1) As currently implemented Council Directive 91/493/EEC of 22 July 1991 laying down the health conditions for the production and the placing on the market of fishery products is not incompatible with the application of provisions of national law which, in respect of fishery products not chemically preserved (in particular, smoked salmon), lay down a policy of zero tolerance of contamination of such foods with Listeria monocytogenes.

(2) These provisions of national law also comply with the requirements of Article 30 EC.