62002CC0286_EN
Opinion of the Advocate-General
Opinion of the Advocate-General
I – Introduction
1. In the present case the Tribunale di Treviso has raised questions concerning Community measures with regard to transmissible spongiform encephalopathies (2) and the feeding of animal protein. (3)
2. The case relates in particular to the interpretation of two technical Community decisions forming the framework for tackling cross-contamination through animal proteins used as feed, as part of the measures taken to combat against BSE.
3. It is clear from the recitals in the preamble to Decision 2000/766 that Community policy in this area was determined by the serious nature of BSE and the ease with which infection can be spread. The third recital, for example, refers to the risk of cross-contamination of cattle feed with feed intended for other animals and which contains animal proteins possibly contaminated by the BSE agent. Since that risk can no longer be excluded, a temporary prohibition was announced on the use of animal protein in animal feedstuffs.
4. The prohibition is laid down in Article 2 of the Decision, and does not apply to, among other things, the feeding of fishmeal to animals other than ruminants. Article 3 of the Decision requires the Member States to prohibit placing on the market, trade, importation from third countries and exportation to third countries, although here again the exception for fishmeal applies.
5. The exception for fishmeal referred to in the previous paragraph applies under the conditions set out in Annex I to Decision 2001/9, which implements Community directives in the field of veterinary checks. (4) The conditions are strict. Annex I provides, amongst other things, that before release for free circulation in Community territory, each consignment of imported fishmeal must be analysed in accordance with Commission Directive 98/88/EC, that the fishmeal must be produced in processing plants dedicated only to fishmeal production, that the fishmeal must be transported directly from the processing plants to the establishments manufacturing animal feed, by means of vehicles which at the same time do not transport other feed materials, and that the vehicle must be thoroughly cleaned and inspected before and after the transport of fishmeal. In short, the measures are designed to prevent any possibility that the fishmeal might contain mammalian bone tissue.
6. More particularly, the national court asks whether, where fishmeal is contaminated with a very small quantity of mammalian bone tissue, the application of those provisions requires zero tolerance, or whether they may allow a certain level of tolerance. It also questions the proportionality of the sanctions which the Italian authorities imposed once they had identified accidentally contaminated fishmeal. Finally, it asks two questions about secondary aspects of the steps taken by the national authorities, including in relation to the fact that the fishmeal in the main proceedings came from Norway.
II – Fact and questions referred
7. The applicant in the main proceedings, Società Bellio Fratelli, imported a consignment of fish flour from Norway in January 2000. The fish flour was subsequently purchased by Società Mangimificio S.A.P.A.S. of San Miniato to be used for the production of feedstuff for animals other than ruminants.
8. During an on-the-spot inspection at S.A.P.A.S. the competent authorities (officers of the Judicial Police of the Service for the Protection of Hygiene and Health) took samples of the fish flour which appeared to contain fragments of unidentified animal bone, with the result that the lot of fish flour supplied by the applicant was seized.
9. Independent analysis carried out on behalf of Società Bellio found the fish flour to contain mammalian bone tissue amounting to less than 0.1%. The review of the analysis carried out by the Board of Health on 27 September 2001 confirmed the presence of bone tissue.
10. The presence of mammalian bone tissue provided the basis for the administrative sanction imposed on Società Bellio ‘for having sold a non-compound feedstuff, namely fish flour, packaged and marketed in such a way as to mislead the purchaser as to the composition, type and nature of the product, and appearing from analysis not to conform to the declarations, indications and descriptions on the label and in the contract documentation accompanying the product’, in the form of an order for the confiscation and destruction of 36 sacks of the fish flour as identified in the seizure order, an order to pay a fine of EUR 18 597.27, and opposition to any other inherent and/or consequential application for relief, whether interlocutory or final.
11. Società Bellio is challenging the imposition of this administrative sanction. In the proceedings relating to this the national court (District Court, Treviso) has referred the following questions to the Court of Justice for a preliminary ruling:
‘1. Are the first indent of Article 2(2) of Decision 2000/766 and Article 1(1) of Decision 2001/9, read together with the other Community rules on which those provisions are based, to be interpreted as meaning that the accidental presence of an unforeseen or prohibited substance in fish flour used in the production of feedingstuffs for animals other than ruminants may be considered to be acceptable de jure or de facto and that, accordingly, traders are allowed a reasonable level of tolerance?
2. If so, in the light of the principle of proportionality and the precautionary principle, and in consideration of the Community provisions applicable in the domains in which reference is made to accidental contamination of food-industry products and indications are given of relevant levels of tolerance, does an accidental contamination of 0.1%, and in any case of not more than 0.5%, of fragments of mammalian bone in fish flour intended for the production of feedingstuffs for animals other than ruminants warrant the adoption of a drastic sanction such as the complete destruction of that fish flour?
3. Does the exclusion of any tolerance in relation to the presence of the substances mentioned in the preceding questions amount to the introduction of a technical standard within the meaning of Directive 83/189/EEC (as amended) (5) which would have to have been notified in advance to the European Commission?
4. Are the provisions of Articles 28 and 30 EC on the free movement of goods, applicable to Norway on the basis of Articles 8 to 16 of the European Economic Area Agreement (EEA Agreement), to be interpreted, with reference to the provisions contained in Decision 2000/766/EC and Decision 2001/9 cited in Question 1 above, as meaning that a Member State may not require zero tolerance in a situation such as that described in Questions 1 and 2 above?’
12. In the order for reference the national court also makes the point that the fish flour seized contained less than 0.1% of mammalian bone fragments, which percentage was not disputed during the proceedings, and it is therefore possible that the contamination was entirely accidental. Accordingly, it may be possible to apply the general principle, upheld in various domains of Community law, of allowing a reasonable level of tolerance.
III – Assessment
A –
Questions 1 and 2
13. The central issue in this case is to be found in Questions 1 and 2. Question 1 concerns the interpretation, and to a certain extent also the validity, of Decisions 2000/766 and 2001/9, as applied by the national authorities. Question 2 concerns the proportionality of that application.
14. The Community system for preventing cross-contamination by transmissible spongiform encephalopathies is very strict. The use of animal protein in feedstuffs is completely prohibited in principle. The only exception is for fishmeal, which cannot itself contain transmissible spongiform encephalopathies, provided that the necessary safeguards have been put in place to ensure that the fishmeal is not contaminated.
15. The measures are designed to prevent fishmeal from coming into contact at any stage of production, processing or transport with other processed animal protein that might be contaminated with spongiform encephalopathies. The measures also go a step further: in order to provide the most effective possible protection against the spread of the disease, the feeding of fishmeal to ruminants is itself completely prohibited.
16. The Court has consistently held that the protection of the health and life of humans ranks foremost among the interests protected in Article 30 EC. (6) Article 152(1) EC also provides that a high level of human health protection must be ensured in the implementation of all Community policies, taking due account of the precautionary principle.
17. On several occasions the Court has had occasion to draw attention to the reality and the seriousness of the risks associated with BSE, and the appropriateness of protective measures justified on the ground of protection of human health in the light of that disease, in respect of measures adopted by either the Commission or a Member State. (7) There are two types of risk: the possible link between BSE and variant Creutzfeldt-Jakob disease in humans, and the real danger that the BSE prion, which is highly persistent, may be transferred through animal meal. (8)
18. The measures to prevent cross-contamination through the presence of animal protein in feedstuffs for ruminants are becoming ever more important in the Community system for combating BSE, and it is in that light that Decision 2000/766 too must be seen. As the Commission explained at the hearing, earlier such measures taken independently by the United Kingdom Government appeared to be highly effective and formed the basis for the present Community decision. The exception for fishmeal not intended for ruminants is therefore limited, and applies only – as is spelled out in the second recital in the preamble to Regulation No 1234/2003 (9) – to fishmeal the use of which does not present a risk of TSEs and does not hamper checks for the presence of proteins which may pose a risk of TSEs.
19. A great deal of attention has been given in the present proceedings to the possibility of there being a permitted tolerance. The applicant’s position is essentially that fish flour intended for animals other than ruminants may contain a negligible quantity of transmissible spongiform encephalopathies. It argues that Community law in general allows for adventitious contamination, and it refers by way of example to the Community rules on genetically modified organisms. Regulation No 49/2000 lays down a maximum tolerance of 1% for the adventitious presence in food ingredients of material from certain genetically modified plants. (10)
20. The applicant’s argument cannot be accepted. As various interveners in the present proceedings have pointed out, Regulation No 49/2000 indicates precisely the opposite. Because there is no general principle in Community law that allows occurrences of adventitious contamination, it was necessary to make specific provision for this in Regulation No 49/2000. What is even more important, in my view, is that it is entirely likely that the presence of transmissible spongiform encephalopathies, even in very low concentrations, presents a risk of the spread of BSE. The Court has already drawn attention to scientific recommendations in this field in the judgment in Eurostock. (11) The BSE prion is persistent and can survive even in low concentrations. In the present case the Irish Government rightly pointed out that low concentrations can present an even greater risk of spreading the disease because they are difficult to detect.
21. It is in that light that the content of Decisions 2000/766 and 2001/9 must be considered. The conditions applicable to fishmeal are to prevent the contamination of fishmeal intended as animal feed, which must not be allowed to come into contact with other animal feedstuffs. The general prohibition on feeding fishmeal to ruminants is linked to this. Where it is not entirely certain that fishmeal, even if it meets the conditions set out in Annex I to Decision 2001/9, is free of contamination, it must not be fed to ruminants.
22. I therefore propose that the Court give the following answer to Question 1: the Community measures to combat BSE, in particular Decision 2000/766 and Decision 2001/9, dictate that fishmeal used as feed for animals other than ruminants must not contain any mammalian bone tissue whatsoever. There is no permitted tolerance under Community law.
23. That brings me to the measures to be taken, to which the national court’s second question relates. The problem is that even where an importer such as the applicant in the main proceedings has taken the necessary measures as prescribed in Community legislation, the fish flour may be found by the competent authorities to have been contaminated. As the national court states, it is even possible that the fish flour has been contaminated accidentally. In such a case is a Member State authorised or even obliged under Community law to impose a sanction?
24. That question must be answered in the light of the principle of proportionality, according to which the seriousness of possible contamination and the risks to public health must be weighed up against the obstacles to freedom of movement and, in connection with that, the requirement of legal certainty for the importer.
25. As the Court has already stated in Eurostock, (12) countries must not permit tissues that are likely to contain the bovine spongiform encephalopathy agent to enter any food chain. The measures taken by Member States must be such as to make absolutely sure that contaminated material does not enter the food chain. Destruction then often becomes the most, and perhaps also the only, appropriate measure.
26. There is therefore no doubt that a Member State must take the measures necessary to give the public the best possible protection against the risks of BSE. That means that if the authorities of the Member State discover contaminated material, they must impose sanctions on those responsible, even if the imposition of (certain) sanctions is not specifically provided for in Community legislation. All of this flows from the criteria developed in case-law for the enforcement of Community law, which must be effective, proportionate and dissuasive, among other things. (13)
27. Because of the major risk of BSE contamination the measure taken was without any doubt, in my view, proportionate.
28. I would add the following point. It is the responsibility of a dealer in fishmeal to do everything he can to prevent the fishmeal from becoming contaminated. At the same time he knows, or ought to know, that even if he has taken all reasonable and necessary steps, there is still no certainty that the fishmeal is not contaminated. And he knows, or ought to know, that from the health protection point of view the destruction of contaminated material is often, as I stated earlier, the only appropriate measure. Trading in fishmeal is thus an activity which entails a certain risk for the operator concerned. The harm which he suffers if there has been contamination through no fault of his own is, in my view, one of the normal business risks of a dealer in fishmeal, for which he can obtain cover in advance.
29. I therefore propose that the Court give the following answer to the national court’s second question: in a case where fish flour intended for the production of feed-stuffs for animals other than ruminants is contaminated by fragments of mammalian bone tissue, the destruction of the contaminated lot of fish flour is a measure which is consistent with the principle of proportionality, even if the contamination is minor and accidental.
B –
Questions 3 and 4
30. In the light of the foregoing I take the view that Questions 3 and 4 do not need to be answered.
31. As regards Question 3, under Article 10 of Directive 98/34 the obligation to notify does not apply to the laws, regulations and administrative provisions of the Member States or voluntary agreements by means of which Member States comply with binding Community acts which result in the adoption of technical specifications. Since the national measure applicable here is designed to implement Decisions 2000/766 and 2001/9 and therefore falls within the scope of those decisions, Question 3 is irrelevant.
32. As regards Question 4, what is unusual about this case is that it concerns fish flour imported from Norway to Italy. Consequently the national court’s application also relates to the interpretation of the European Economic Area Agreement, in particular Articles 13 and 20 of the Agreement and Article 2(5) of the Protocol on trade in fish and other marine products.
33. However, since a requirement of zero tolerance applies in internal trade and the restrictive measure at issue – including the sanction imposed on the applicant in the main proceedings – is permitted by internal Community law, there is no need to consider to what extent the trade in fish flour is covered by the European Economic Area Agreement. It can never follow from that Agreement that a restrictive measure which is required – or at least permitted – in internal trade is not permitted under subordinate Community legislation for the import of a product from a country which is not a Member State, but is a party to the said Agreement. In a case where the relevant Community rules are not binding for imports from such a country, the trade barrier is justified by the provisions of Article 13 of the European Economic Area Agreement, which is equivalent to Article 30 EC.
IV – Conclusion
34. In the light of the foregoing I propose that the Court give the following answer to the questions referred by the Tribunale di Treviso:
– Question 1: The Community measures to combat BSE, in particular Council Decision 2000/766/EC of 4 December 2000 concerning certain protection measures with regard to transmissible spongiform encephalopathies and the feeding of animal protein and Commission Decision 2001/9 of 29 December 2000 concerning control measures required for the implementation of Council Decision 2000/766/EC, dictate that fish flour used as feed for animals other than ruminants must not contain any fragments of mammalian bone tissue. There is no permitted tolerance under Community law.
– Question 2: in a case where fish flour intended for the production of feed-stuffs for animals other than ruminants is contaminated by fragments of mammalian bone tissue, the destruction of the contaminated lot of fish flour is a measure which is consistent with the principle of proportionality, even if the contamination is minor and accidental.
– Questions 3 and 4: these questions do not need to be answered.
(1) .
(2)
–	Also referred to, including in this Opinion, as TSEs.
(3)
–	In particular Council Decision 2000/766/EC of 4 December 2000 concerning certain protection measures with regard to transmissible spongiform encephalopathies and the feeding of animal protein (OJ 2000 L 306, p. 32, hereinafter referred to as Decision 2000/766) and Commission Decision 2001/9 of 29 December 2000 concerning control measures required for the implementation of Council Decision 2000/766/EC (OJ 2001 L 2, p. 32, hereinafter referred to as Decision 2001/9).
(4)
–	Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market (OJ 1989 L 395, p. 13), in particular Article 9(4), Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (OJ 1990 L 224, p. 29), in particular Article 10(4), and Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (OJ 1998 L 24, p. 9), in particular Article 22.
(5)
– Directive 83/189/EEC, the notification directive, was replaced in August 1998 by Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations (OJ 1998 L 204, p. 37). It is this latter directive that is referred to, strictly speaking.
(6)
–	See, for example, the judgment in Case C-121/00 Hahn
[2002] ECR I-9193, paragraph 38.
(7)
–	See, among others, the judgment in Case C-393/01 France
v Commission
[2003] ECR I-5456, paragraph 42.
(8)
–	See also, in this connection, the judgment in Case C-220/01 Lennox
[2003] ECR I-7091.
(9)
–	Commission Regulation (EC) No 1234/2003 of 10 July 2003 amending Annexes I, IV and XI to Regulation (EC) No 999/2001 of the European Parliament and of the Council and Regulation (EC) No 1326/2001 as regards transmissible spongiform encephalopathies and animal feeding, OJ 2003 L 173, p. 6.
(10)
–	Commission Regulation (EC) No 49/2000 of 10 January 2000 amending Council Regulation (EC) No 1139/98 concerning the compulsory indication on the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 79/112/EEC, OJ 2000 L 6, p. 13.
(11)
–	Case C-477/98 [2000] ECR I-10695, paragraphs 63 to 66.
(12)
–	Cited in footnote 11, paragraph 63.
(13)
–	See, for example, Case 68/88 Commission
v Greece
[1989] ECR 2965.