C-286/02

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OPINION OF M R GEELHOED — CASE C-286/02

directives in the field of veterinary checks. 4 nated with a very small quantity of The conditions are strict. Annex I provides, mammalian bone tissue, the application of amongst other things, that before release those provisions requires zero tolerance, or for free circulation in Community territory, whether they may allow a certain level of each consignment of imported fishmeal tolerance. It also questions the proportion- must be analysed in accordance with ality of the sanctions which the Italian Commission Directive 98/8 8/EC, that the authorities imposed once they had identi- fishmeal must be produced in processing fied accidentally contaminated fishmeal. plants dedicated only to fishmeal produc- Finally, it asks two questions about sec- tion, that the fishmeal must be transported ondary aspects of the steps taken by the directly from the processing plants to the national authorities, including in relation to establishments manufacturing animal feed, the fact that the fishmeal in the main by means of vehicles which at the same time proceedings came from Norway. 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.

I I— Fact and questions referred

7. The applicant in the main proceedings, Società Bellio Fratelli, imported a consign- ment 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. 6. More particularly, the national court asks whether, where fishmeal is contami-

10. The presence of mammalian bone tissue provided the basis for the adminis- trative 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 2. If so, in the light of the principle of to conform to the declarations, indications proportionality and the precautionary and descriptions on the label and in the principle, and in consideration of the contract documentation accompanying the Community provisions applicable in product', in the form of an order for the the domains in which reference is made confiscation and destruction of 36 sacks of to accidental contamination of food- the fish flour as identified in the seizure industry products and indications are order, an order to pay a fine of EUR given of relevant levels of tolerance, 18 597.27, and opposition to any other does an accidental contamination of inherent and/or consequential application 0 . 1 % , and in any case of not more for relief, whether interlocutory or final. than 0 . 5 % , of fragments of mamma-

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lian bone in fish flour intended for the meaning that a Member State may not production of feedingstuffs for animals require zero tolerance in a situation other than ruminants w a r r a n t the such as that described in Questions 1 adoption of a drastic sanction such as and 2 above?' the complete destruction of that fish flour?

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 percen- tage was not disputed during the proceed- 3. Does the exclusion of any tolerance in ings, and it is therefore possible that the relation to the presence of the sub- contamination was entirely accidental. stances mentioned in the preceding Accordingly, it may be possible to apply questions amount to the introduction the general principle, upheld in various of a technical standard within the domains of Community law, of allowing a meaning of Directive 83/189/EEC (as reasonable level of tolerance. amended) 5which would have to have been notified in advance to the Eur- opean Commission?

14. The Community system for preventing implementation of all Community policies, cross-contamination by transmissible spon- taking due account of the precautionary giform encephalopathies is very strict. The principle. 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 neces- sary safeguards have been put in place to ensure that the fishmeal is not contami- nated. 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. 7There are two types of risk: the 15. The measures are designed to prevent possible link between BSE and variant fishmeal from coming into contact at any Creutzfeldt-Jakob disease in humans, and stage of production, processing or transport the real danger that the BSE prion, which is with other processed animal protein that highly persistent, may be transferred might be contaminated with spongiform through animal meal. 8 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 fish- meal to ruminants is itself completely prohibited.

18. The measures to prevent cross-contam- ination 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 16. The Court has consistently held that 2000/766 too must be seen. As the Com- the protection of the health and life of mission explained at the hearing, earlier humans ranks foremost among the interests such measures taken independently by the protected in Article 30 EC. 6Article 152(1) United Kingdom Government appeared to EC also provides that a high level of human be highly effective and formed the basis for health protection must be ensured in the

the present Community decision. The 20. The applicant's argument cannot be exception for fishmeal not intended for accepted. As various interveners in the ruminants is therefore limited, and applies present proceedings have pointed out, only •—· as is spelled out in the second recital Regulation N o 49/2000 indicates precisely in the p r e a m b l e t o R e g u l a t i o n N o the opposite. Because there is no general 1234/2003 9 — to fishmeal the use of which principle in Community law that allows does not present a risk of TSEs and does not occurrences of adventitious contamination, hamper checks for the presence of proteins it was necessary to make specific provision which may pose a risk of TSEs. for this in Regulation N o 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 recom- mendations in this field in the judgment in Eurostock. 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 spread- ing the disease because they are difficult to 19. A great deal of attention has been given detect. 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 quan- tity of transmissible spongiform encephalo- pathies. It argues that Community law in general allows for adventitious contamina- tion, and it refers by way of example to the Community rules on genetically modified organisms. Regulation N o 49/2000 lays down a maximum tolerance of 1% for the adventitious presence in food ingredients of material from certain genetically modified plants. 10 2 1 . 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 9 — Commission Regulation (EC) No 1234/2003 of 10 July of fishmeal intended as animal feed, which 2003 amending Annexes I, IV and XI to Regulation (EC) No 999/2001 of the European Parliament and of the Council must not be allowed to come into contact and Regulation (EC) No 1326/2001 as regards transmissible spongiform encephalopathies and animal feeding, OJ 2003 with other animal feedstuffs. The general L 173, p. 6. prohibition on feeding fishmeal to rumi- 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.

23. That brings me to the measures to be taken, to which the national court's second 26. There is therefore no doubt that a question relates. The problem is that even Member State must take the measures where an importer such as the applicant in necessary to give the public the best possible the main proceedings has taken the neces- protection against the risks of BSE. That sary measures as prescribed in Community means that if the authorities of the Member legislation, the fish flour may be found by State discover contaminated material, they the competent authorities to have been must impose sanctions on those responsi- contaminated. As the national court states, ble, even if the imposition of (certain) it is even possible that the fish flour has sanctions is not specifically provided for in been contaminated accidentally. In such a Community legislation. All of this flows case is a Member State authorised or even obliged under Community law to impose a sanction? 12 — Cited in footbnote 11, paragraph 6 3 .

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from the criteria developed in case-law for 29. I therefore propose that the Court give the enforcement of Community law, which the following answer to the national court's must be effective, proportionate and dis- second question: in a case where fish flour suasive, among other things. 13 intended for the production of feed-stuffs for animals other than ruminants is con- taminated by fragments of mammalian bone tissue, the destruction of the contami- nated lot of fish flour is a measure which is consistent with the principle of proportion- ality, even if the contamination is minor and accidental.

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BELLIO F.LLI

32. As regards Question 4, what is unusual sanction imposed on the applicant in the about this case is that it concerns fish flour main proceedings — is permitted by inter- imported from Norway to Italy. Conse- nal Community law, there is no need to quently the national court's application also consider to what extent the trade in fish relates to the interpretation of the European flour is covered by the European Economic Economic Area Agreement, in particular Area Agreement. It can never follow from Articles 13 and 20 of the Agreement and that Agreement that a restrictive measure Article 2(5) of the Protocol on trade in fish which is required — or at least permitted — and other marine products. 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 33. However, since a requirement of zero Article 13 of the European Economic Area tolerance applies in internal trade and the Agreement, which is equivalent to Article restrictive measure at issue — including the 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