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Decyzji w sprawie 2115/2007/FOR - Spór dotyczący przywozu wołowiny z Brazylii

Skarżący – organizacja z Wielkiej Brytanii i Irlandii reprezentująca rolników – zarzucił, że Komisja wstrzymała się od nałożenia zakazu na przywóz wołowiny do UE z Brazylii, mimo uzyskanych w marcu 2007 r. dowodów, że przywożone mięso stwarza ryzyko związane w szczególności z pryszczycą, na którą chorują takie zwierzęta jak bydło. W trakcie dochodzenia prowadzonego przez Rzecznika skarżący przedstawił dodatkowy zarzut, a mianowicie że po otrzymaniu sprawozdania z misji przeprowadzonej w listopadzie 2007 r. w Brazylii przez swoje Biuro ds. Żywności i Weterynarii Komisja nie podjęła racjonalnych i proporcjonalnych działań w związku z zagrożeniem dla zdrowia zwierząt i zdrowia publicznego, jakie stanowi wołowina przywożona z Brazylii.

Rzecznik zauważył, że Komisja może, zgodnie z mającym zastosowanie ustawodawstwem, podjąć decyzję o przyjęciu w przypadkach niezgodności ze strony Brazylii odpowiednich środków, obejmujących (i) wprowadzenie zakazu przywozu, (ii) ustanowienie szczegółowych warunków, (iii) określenie wymogów dotyczących odpowiednich kontroli. Komisja uznała, że mimo iż rzeczywiście podczas misji Biura ds. Żywności i Weterynarii w marcu 2007 r. stwierdzono pewne niedociągnięcia, nie mają one charakteru, którym można by uzasadnić wprowadzenie natychmiastowego zakazu. Zamiast zastosować taki środek, Komisja zdecydowała o przeprowadzeniu dodatkowych kontroli. Rzecznik, uwzględniając informacje udostępnione Komisji w odpowiednim czasie, nie uznał przyjętego przez nią stanowiska za rażąco niewłaściwe. Tym samym stwierdził, że nie miał miejsca przypadek niewłaściwego administrowania, jeżeli chodzi o ten aspekt zarzutu.

W odniesieniu do dodatkowego zarzutu Rzecznik zauważył, że „poważne uchybienia” zostały stwierdzone po misji przeprowadzonej w listopadzie 2007 r. w Brazylii. Nie spowodowało to wprowadzenia zakazu przywozu wołowiny z Brazylii, ale skłoniło Komisję do nałożenia „specjalnych warunków” dotyczących takiego przywozu. W ramach tych specjalnych warunków zasadniczo zobowiązano władze brazylijskie do wdrożenia systemu zatwierdzonych hodowli bydła, co pozwoliłoby stworzyć „zamknięty system” do celów wywozu do UE. Rzecznik nie uważa, że Komisja popełniła rażący błąd, nakładając takie szczegółowe warunki zamiast pełnego zakazu. Tym samym stwierdził, że nie miał miejsca przypadek niewłaściwego administrowania, jeżeli chodzi o ten aspekt zarzutu.

Rzecznik uznał jednak, że Komisja nie przedstawiła wystarczających powodów, dla których w okresie od dnia 1 lutego 2008 r. do dnia 15 marca 2008 r. zezwoliła na przywóz dostaw wołowiny z Brazylii do UE, mimo że w żadna hodowla, z której pochodziło mięso, nie została objęta audytami i inspekcjami, zgodnie z wymogami Komisji, których spełnienie uznano za konieczne w celu wyeliminowania ryzyka dla zdrowia zwierząt. W związku z powyższym Rzecznik wystosował uwagę krytyczną w odniesieniu do tego aspektu zarzutu. Rzecznik wystosował także dodatkową uwagę, że Komisja powinna kontynuować regularne misje w państwach trzecich w celu przeprowadzania systematycznych kontroli.

THE BACKGROUND TO THE COMPLAINT

1. Foot and mouth disease is a highly contagious viral disease affecting certain animals, in particular, cattle, sheep, pigs, goats and deer.[1] Different zones in Brazil have different foot and mouth disease statuses. The World Organisation for Animal Health[2] considers[3] that only one State[4] in Brazil is "foot and mouth disease-free 'without vaccination'". Certain zones in Brazil are "foot and mouth disease-free 'with vaccination'". All other zones in Brazil are "not foot and mouth disease-free". The EU is currently recognised by the World Organisation for Animal Health as being "foot and mouth disease-free 'without vaccination'".

THE SUBJECT-MATTER OF THE INQUIRY

2. The complainant, Fairness for Farmers in Europe (a federation of farm organisations based in the United Kingdom and Ireland), alleged that the European Commission failed to take action required of it under EU law when it refrained from banning beef imports into the EU from Brazil, notwithstanding evidence that such imports posed a risk to human and animal health. The Ombudsman understood the allegation to refer to the failure to take action by the date the complaint was submitted to the Ombudsman, namely, 6 July 2007.

3. The Ombudsman understood the complainant to claim, in summary, that the Commission should impose a ban on the importation of Brazilian beef.

4. During the course of the inquiry, the complainant made an additional allegation, namely, that the Commission, having received the Final Report from the Food and Veterinary Office[5] in relation to the Food and Veterinary Office's November 2007 mission to Brazil, failed to act reasonably and proportionately to deal with the threat to animal and public health.

THE INQUIRY

5. On 6 July 2007, the complainant submitted its complaint to the Ombudsman. On 20 July 2007, the Ombudsman opened an inquiry. On 10 December 2007, the Commission sent its opinion to the Ombudsman. On 31 January 2008, the complainant sent to the Ombudsman its observations in relation to the Commission's opinion.

6. On 16 April 2008, the complainant informed the Ombudsman's services that it wished to make additional observations in light of the publication of the Commission's Final Report relating to a mission to Brazil carried out by its Food and Veterinary Office from 6 to 9 November 2007. The mission had as its purpose the evaluation of the animal health controls in place in Brazil relating, in particular, to foot and mouth disease, public health control systems and certification processes. On the basis of the Final Report of the mission of 6 to 9 November 2007, the Commission, on 17 January 2008, took a decision imposing certain restrictions on the imports of fresh bovine meat from Brazil[6]. The Ombudsman agreed to the complainant's request to make additional observations.

7. On 30 May 2008, the complainant sent further observations.

8. On 12 September 2008, the Ombudsman undertook further inquiries by sending a letter to the Commission. In his letter, the Ombudsman noted that, in its further observations of 30 May 2008, the complainant had made an additional allegation, namely, that the Commission, having received the Final Report from the Food and Veterinary Office following its November 2007 mission to Brazil, failed to act reasonably and proportionately to deal with the threat to animal and public health. The Ombudsman also pointed out in his letter that the complainant had argued that Decision 2008/61/EC constituted an unreasonable and disproportionately small response to the threat to animal health identified in the Final Report.

9. On 10 December 2008, the Commission sent its further opinion to the Ombudsman. On 30 January 2009, the complainant sent its further observations in relation to the Commission's opinion.

THE OMBUDSMAN'S ANALYSIS AND CONCLUSIONS

A. The allegation that the European Commission failed, by the date of the submission of the complaint to the Ombudsman, to take action required of it under EU law when it refrained from banning beef imports into the European Union from Brazil, notwithstanding evidence that such imports posed a risk to human and animal health

Arguments presented to the Ombudsman

10. In its opinion to the Ombudsman, the Commission recognised that foot and mouth disease is indeed one of the most contagious animal diseases and that it can cause severe economic losses.

11. The Commission explained that the World Organisation for Animal Health has established detailed standards and requirements to prevent the spread of foot and mouth disease. The World Trade Organisation (WTO) has also put in place the Agreement of Sanitary and Phytosanitary measures ('the SPS Agreement'). The SPS Agreement states that restrictions on trade in the field of food safety and animal and plant health must be based solely on science. The Commission explained that the SPS Agreement allows countries to use different standards and different methods of inspecting products. It also includes provisions on control, inspection, approval procedures, and regionalisation.

12. The Commission then explained the EU beef import requirements. It outlined that the EU has had an effective importation policy in place for a number of years. It continuously adapts the importation policy to take into account the current disease situation in third countries as well as scientific developments. The Commission noted that the EU requirements for beef imports are fully in line with the principles of the SPS Agreement.

13. In accordance with Article 8 of Council Directive 2002/99/EC, imports of products of animal origin are only permitted from third countries, or parts thereof, which have been specifically authorised following an EU audit of the animal health situation within the country in question. The Commission explained that the aim of the EU audit is to demonstrate that the competent veterinary authorities provide adequate guarantees as regards compliance or equivalence with relevant EU animal health conditions. Such audits are carried out by the Commission's Food and Veterinary Office.

14. The Commission explained that the products of animal origin must comply with the requirements laid down in the appropriate import certificate, as established by Council Decision 79/542/EEC[7]. It noted that, for bovine meat, the certificate lays down requirements at several levels, including requirements relating to (a) the territory of origin, which must be free of foot and mouth disease (with or without vaccination); (b) the holding of origin; (c) the animals themselves; (d) the controls on animal movements; and (e) the conditions at slaughter and during meat production and storage.

15. The Commission recalled that, in accordance with Regulation 178/2002,[8] the European Food Safety Authority (EFSA) is the keystone of the EU risk assessment regarding food and feed safety. EFSA provides independent scientific advice and clear communications on existing and emerging risks. The Commission noted that the protective mechanisms developed by the EU to reduce the risk of the introduction of foot and mouth disease into the EU have been assessed by EFSA. In its opinion, EFSA recognised that the protective mechanisms developed by the EU are very effective in reducing the risk of foot and mouth disease entering the EU.

16. The Food and Veterinary Office is a Directorate of the Commission's Directorate-General for Health and Consumer Protection (the Directorate-General is known as DG SANCO). The Food and Veterinary Office's principal responsibilities are to evaluate compliance with (a) EU food and veterinary standards within the EU and (b) EU food and veterinary standards, or equivalence to such standards, in third countries that export food to the EU. In this context, it carries out on-the-spot inspections or audits in Member States and in third countries exporting to the EU, in order to verify the performance of their food and veterinary control systems.

17. When, in the course of an inspection in either a Member State or a third country, serious instances of non-compliance are detected, the risk posed by the non-compliance is technically assessed by experts in the Commission's services, including Food and Veterinary Office inspectors. Then, an appropriate "risk management" strategy is determined and a schedule for appropriate subsequent actions is laid down.

18. The findings of each inspection, together with the conclusions and the recommendations addressed to the competent authorities, are set out in a detailed inspection report. In respect of the recommendations contained in the report, the competent authority is requested to present an "action plan" to the Food and Veterinary Office on how it intends to address the recommendations. The Food and Veterinary Office, in conjunction with other Commission services, evaluates this action plan and systematically monitors its implementation through a number of follow-up activities. The Commission explained that the reports are subject to a series of quality and legal checks and the competent authority of the country visited is given the opportunity to comment on the reports at their draft stage. Reports, once finalised, are circulated to the competent authorities of the Member States, to the European Parliament, and published on the Food and Veterinary Office website.

19. The Commission noted that, from September 2005 to the date of its opinion, the Food and Veterinary Office carried out five missions to Brazil to evaluate the animal health controls in place, in particular for foot and mouth disease, and two missions to evaluate the control of residues and contaminants in live animals and animal product. This was a particularly high frequency of inspections for the Food and Veterinary Office. The Commission concluded that this rigorous series of inspections showed that it had kept the situation in Brazil under continuous review and was in a position to evaluate if the Brazilian authorities had given an appropriate follow-up to the shortcomings identified in previous missions. The Commission pointed out that, following each mission, it had assessed the findings and taken appropriate actions.

20. The Commission attached an annex to its opinion in which it listed the restrictive actions it took in relation to imports of products of animal origin from Brazil. It noted that in October 2005, following an outbreak of foot and mouth disease in the Brazilian state of Mato Grosso do Sul, the Commission suspended imports of meat from bovine animals coming from this state and from the neighbouring states of Paranࡡnd Sao Paulo. (It also noted that, in November 2005, it adopted an urgent decision to suspend the import of honey and farmed game meat due to residue problems.)

21. The Commission explained that the Food and Veterinary Office reports did not lead to similar actions in relation to imports of beef coming from approved states in Brazil. Certain shortcomings were identified during Food and Veterinary Office missions, but they were not of a nature that would justify any immediate further import restrictions. The Commission noted that it had asked the Brazilian authorities to provide, by the end of the year 2007, auditable evidence of the rectification of the remaining deficiencies. It was only after examining these data that the Commission would consider the issue of the authorisation of beef exports. Up to the date of writing its opinion[9], the Brazilian authorities had sent a number of documents in response to its request. In addition, the Food and Veterinary Office had scheduled a further mission to Brazil for November 2007 to ensure that those deficiencies had been correctly addressed by the Brazilian authorities.

22. The Commission received abundant correspondence from farmers associations, MEPs and national governments in relation to Brazilian beef imports. It stated that it had responded thoroughly to the written and oral Parliamentary Questions it received. The Commission also noted that, on 10 July 2006 and on 16 July 2007, its officials, including the Director of the Food and Veterinary Office, met with representatives of farmers associations, including the complainant's federation, and MEPs. The Commission finally recalled that, on 16 July 2007, it explained its import policy for beef from Brazil to the European Parliament's Committee on Agriculture and Rural Development.

23. The Commission added that it had prepared a detailed assessment of the claims made by one of the associations in the complainant's federation in a report on the practices of the Brazilian beef industry published by the association. This report allegedly showed serious shortcomings in the implementation of the EU import requirements for beef that should have induced the Commission to suspend the imports of Brazilian beef. The Commission noted that its assessment of the issues addressed in the association's report had been sent to all concerned MEPs and was presented to Member States at the meeting of the Committee on the Food Chain and Animal Health on 19 July 2007. No Member State expressed support for the association or asked for a change in the current import policy as regards Brazilian beef.

24. Furthermore, the Commission recalled that, on 9 October 2007, the Commissioner responsible for DG SANCO explained to the European Parliament's Committee on Agriculture and Rural Development why the Food and Veterinary Office's findings in Brazil did not justify an immediate change of EU policy vis-ஶis beef imports from Brazil. He also explained that, in light of certain cases of non-compliance identified during the Food and Veterinary Office's inspections, the Brazilian authorities were asked to provide auditable evidence of the rectification of these remaining shortcomings by the end of the year.

25. The Commission rejected any allegation of maladministration because it did not see a valid argument that would substantiate the allegation that the Commission failed to act in accordance with the rules or principles binding upon it.

26. The Commission explained that its decisions on the most appropriate measures to ensure that beef imported into the EU from Brazil is in compliance with EU legislation, were taken in accordance with applicable legislation and following a thorough consideration of the factual and scientific knowledge available.

27. The Commission recalled that Council Directive 2002/99/EC empowers it to establish the list of third countries (or parts thereof), from which imports of products of animal origin are permitted. The decision to include a third country on that list is a "risk management" action, the competence for which is given to the Commission.

28. The Commission also recalled that, in establishing this list, laid down in Council Decision 79/542/EEC, the Commission took particular account of the organisation of the competent veterinary authority in the third country and its inspection services, as well as of the assurances given by the competent veterinary authority regarding compliance or equivalence with relevant EU animal health conditions.

29. The Commission highlighted that it fully assessed the findings of the seven missions undertaken by the Food and Veterinary Office in Brazil. Appropriate action was taken following each of the inspections, in a transparent manner. The Food and Veterinary Office inspections in Brazil did not identify findings that would justify, up to the date of writing, the banning of Brazilian beef imports. The Commission believed its actions to have been proportionate and non-discriminatory.

The complainant's observations

30. The complainant first noted that, in January 2008, the Commission took a decision which began to rectify fundamental weaknesses in the procedures to eliminate the risk of foot and mouth disease in imported beef from Brazil. However, this decision did not affect the allegation made by the complainant (namely, that the Commission failed, by the date of the submission of the complaint to the Ombudsman, to ban imports of beef from Brazil).

31. The complainant stated that the European Commission both failed to ban and also delayed banning imports of beef from Brazil, notwithstanding evidence that such imports posed an immediate and substantial risk to animal health in the form of the introduction and spread of foot and mouth disease. Given the nature and the virulence of the foot and mouth virus, this failure to act, and/or the delay in acting, exposed farmers and the general rural community to an unwarranted high risk of substantial losses arising from this disease. In failing to act, or in its delay in acting in accordance with established and accepted standards and EU law, the European Commission behaved in a negligent, incompetent and discriminatory way.

32. The complainant stated that the acceptance by the Commission of arrangements in Brazil, which fundamentally breached the safeguards required by international and EU standards as well as by EU law, constituted maladministration. The complainant made, in particular, reference to the findings of the Food and Veterinary Office's report of its mission to Brazil from 14 to 27 March 2007.

33. The complainant stated that the provisions in EU law setting out the requirements for the lawful importation of beef into the EU do not justify the level of discretion and delay which the European Commission assumed it possessed in this case.

34. The complainant then referred to a statement made by Commissioner Kyprianou in response to questions raised on 9 October 2007 at the European Parliament's Committee on Agriculture and Rural Development. On that occasion, Mr Kyprianou stated that the EU's policy has been "assessed by the European Food Safety Authority (EFSA) and it has recognised that the measures in place are very effective to reduce the risk of introduction of foot and mouth disease into the EU." In reference to this statement, the complainant noted that the EFSA opinion referred to by the Commissioner was confined exclusively to the "risk assessment" and policy measures required in order to assess the risk of foot and mouth disease entering the EU. In other words, the complainant considered that EFSA opinion dealt with the "model" of measures "proposed" by the Brazilian authorities, not with the measures "actually put in place" in Brazil. The complainant concluded that EFSA never "recognised" that the measures actually put in place were very effective in reducing the risk of foot and mouth disease entering the EU.

35. The complainant also noted that, in its opinion, the Commission relied on EFSA's opinion, but disregarded the evidence provided by the Food and Veterinary Office reports according to which fundamental aspects of the sophisticated control system were either not operating satisfactorily or were completely missing in Brazil.

36. In its opinion, EFSA also warned against the risk of spreading foot and mouth disease through legal and illegal activities. The complainant stated that this warning could not justify the Commission's approach in relation to the serious shortcomings or non-existence of animal monitoring systems in Brazil.

37. The complainant then summarised the European measures in place which are applicable to imported beef. He noted that, although some European requirements, such as deboning, are stricter than international standards, these requirements are always meant to work in addition to, and not instead of, the international standards (such as identification and traceability of animals).

38. The complainant then discussed the report from the Veterinary Epidemiology and Economics Research Unit of the University of Reading, which the complainant's federation had commissioned. The report is primarily based on the Food and Veterinary Office reports drafted after the inspections in Brazil concerning foot and mouth disease. According to the report, major breaches of rules and standards existed in Brazil. The report assessed their impact from a veterinary risk analysis perspective and concluded that: "This study indicates that, in Brazil, the animal health and hygiene controls on cattle and beef production for the EU export market are inferior to those maintained within the EU. The risk analysis indicates that systems failures throughout the export chain are of a magnitude to indicate that there is a significant possibility that foot and mouth disease virus could enter the Community with imported Brazilian beef."

39. The complainant addressed the Commission's statement that, wherever serious non-compliance is detected in the course of an inspection, the non-compliance is assessed and the appropriate risk management strategy is established. It first expressed surprise at the fact that a finding of serious non-compliance (such as the failures in relation to the identification of cattle) does not automatically bring about a ban. It was of the opinion that, as argued in the report it attached to its observations, the manifest failures in the Brazilian system and practices give rise to a significant possibility that the foot and mouth disease virus could enter the EU with imported Brazilian beef. It stated that it was unacceptable and highly imprudent for the Commission to state that an appropriate risk management strategy could, in any meaningful way, compensate for serious non-compliance.

40. The complainant maintained its allegation that the Commission was not justified in concluding that the shortcomings identified during the Food and Veterinary Office missions were not of a nature that would require an immediate restriction or a complete ban.

41. The complainant also noted that the discretion granted to the Commission by Council Directive 2002/99/EC does not extend to allowing fundamental breaches of EU law and standards, the outcome of which is that the scientifically-based protection designed to prevent the import of foot and mouth disease is rendered meaningless.

42. In its further observations, the complainant stated that, when the Commission (eventually) imposed severe restrictions on imports of beef from Brazil in January 2008, it precisely described and acknowledged the "enormity of the longstanding risk" resulting from the importation of beef from Brazil.

43. The complainant went on to state that the Commission's action in January 2008 was "not due to an increased risk of exposure but rather a belated response by the Commission to a long-established risk which they were aware of or of which they ought to have been aware". In this respect, it argued that the November 2007 Mission Report, together with previous Mission Reports, and the knowledge the Commission would reasonably be expected to have available to it, demonstrated that non-compliance with EU law was ongoing, and that the situation was deteriorating. In sum, it argued that, without objective justification, and without regard to the principles of proportionality or legitimate expectations, the Commission had permitted flagrant and systemic breaches of EU law to occur over a number of years.

44. It also argued that the March 2008 Mission Report shows that the competent Brazilian authorities took strong, speedy and effective action on the basis of Commission Decision 2008/61/EC. Accordingly, had the Commission imposed such sanctions at an earlier point, the same result would have been achieved earlier, thus reducing significantly the risk taken by the Commission to animal and public health. This failure to act earlier can only be described as maladministration.

45. The complainant noted that the fact that no outbreak of Foot and Mouth Disease has, thus far, resulted from importation of beef from Brazil is no justification for non-compliance with the rules designed to deal with the risk of importing Foot and Mouth Disease. Furthermore, this fact cannot be used to justify a claim that the Commission's response was proportionate. In sum, the argument that Foot and Mouth Disease has never been caused by legally imported beef could never exonerate or justify the kind of lax approach adopted by the Commission in tolerating the situation in Brazil prior to January 2008. It argued that full identification, movement-control and other measures were essential for the effective operation of the import regime set out in EU law to prevent the spread of Foot and Mouth Disease. It argued that the threats from Foot and Mouth Disease has given rise to robust and internationally recognised regimes to prevent the spread of Foot and Mouth Disease. In the complainant's view, the Commission ignored these well-established principles of control.

46. In concluding, the complainant remained of the view that the complaint of maladministration was justified and fully supported by events and patterns prior to the complaint. Moreover, the complaint is additionally justified by the actions and statements of the Commission subsequent to the complaint. The complainant questioned why, if the Commission's behaviour prior to the complaint was in proper execution of its responsibilities, does it now accept the extent and unjustifiable nature of the risk it was taking with animal health within the EU.

The Ombudsman's assessment

47. The Ombudsman notes at the outset that the first allegation and the related claim concern the alleged failure of the Commission to take action by July 2007 (when the complaint concerning the importation of beef originating from Brazil was submitted to the Ombudsman). As a result, the Ombudsman, when reviewing this allegation, will only take into consideration the information available to the Commission by July 2007.

48. Article 11 of Regulation 178/2002, which lays down the general principles and requirements of EU food law, states that:

"Food and feed imported into the Community for placing on the market within the Community shall comply with the relevant requirements of food law or conditions recognised by the Community to be at least equivalent thereto or, where a specific agreement exists between the Community and the exporting country, with requirements contained therein."

49. Article 7 of Council Directive 2002/99/EC, which lays down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption, states that:

"Member States shall take measures to ensure that products of animal origin intended for human consumption are introduced from third countries only if they comply with the requirements of Chapter I applicable to all stages of the production, processing and distribution of such products in the Community or if they offer equivalent animal health guarantees."

50. The main requirements of Chapter I of Council Directive 2002/99/EC are as follows. Products of animal origin must be obtained from animals which do not come from a holding, establishment, territory or part of a territory subject to animal health restrictions[10]. Chapter I also states that if a "serious animal health risk" is identified during a Commission audit or inspection, "all measures necessary to safeguard animal health" shall immediately be taken. It is clear that such measures could, if it were deemed necessary, include a complete suspension of the sale of products of animal origin from the affected area. However, such measures could also include less onerous measures, provided such measures are sufficient to safeguard animal and public health.

51. Article 8 of Council Directive 2002/99/EC states that, in order to ensure compliance with the general obligation laid down in Article 7 of Council Directive 2002/99/EC, lists of third countries, or regions of third countries, from which imports of specified products of animal origin are permitted[11], shall be established. A third country can only appear on such lists if an EU audit of that country has taken place and demonstrates that the competent veterinary authority provides "appropriate guarantees" as regards compliance with EU legislation. The Ombudsman understands that "appropriate guarantees" refer to the need for the third country to demonstrate that it has taken all measures "necessary to safeguard animal health".

52. Article 10 of Council Directive 2002/99/EC reads as follows:

"1. Community inspections and/or audits at all stages covered by this Directive may be carried out in third countries by experts from the Commission in order to verify conformity with or equivalence to Community animal health rules. The experts from the Commission may be accompanied by experts from the Member States authorised by the Commission to carry out these inspections and/or audits.

2. The inspections and/or audits in third countries referred to in paragraph 1 shall be carried out on behalf of the Community, and the Commission shall meet the costs incurred.

3. The procedure for carrying out the inspections and/or audits in third countries referred to in paragraph 1 may be established or modified in accordance with the procedure referred to in Article 12(2).

4. If a serious animal health risk is identified during a Community inspection or audit, the Commission shall immediately take the measures necessary to safeguard animal health, in accordance with Article 22 of Directive 97/78/EC, and inform the Member States thereof."

53. Article 53 of Regulation 178/2002 also states that:

"Where it is evident that food or feed originating in the Community or imported from a third country is likely to constitute a serious risk to human health, animal health or the environment, and that such risk cannot be contained satisfactorily Ŭ the Commission Šshall immediately adopt one or more of the following measures, depending on the gravity of the situation: Š

(b) in the case of food or feed imported from a third country:

(i) suspension of imports of the food or feed in question from all or part of the third country concerned and, where applicable, from the third country of transit;

(ii) laying down special conditions for the food or feed in question from all or part of the third country concerned;

(iii) any other appropriate interim measure."

54. It is clear from the above that the nature and extent of measures adopted to deal with a specific, serious threat to animal or public health resulting from products of animal origin imported into the EU from third countries will depend on the "gravity of the situation" relating to animal health in the third country concerned. While the Commission is empowered to suspend the importation of animal products from all or part of a third country (that is, it can impose a temporal "ban" on such imports), it may also, if the risks to animal and human health are, even though "serious", deemed to be less intense, impose less onerous measures. These less onerous measures include setting "special conditions" in respect of imports of such products from the third country or drawing up "requirements for appropriate checks".

55. The Ombudsman also considers that, by ensuring that restrictions in the field of food safety and animal and plant health are based on the "gravity of the situation", the Commission will ensure that any measures it takes are in accordance with the EU's obligations under the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (the SPS Agreement). It is recalled that the SPS Agreement states that restrictions on trade in the field of food safety and animal and plant health must be based solely on science, must be proportionate and must be non-discriminatory[12].

56. The Ombudsman now considers it useful to draw a distinction between (1) findings of the Food and Veterinary Office relating to the presence of animal or human health threats in herds located in specific regions of Brazil and (2) findings of the Food and Veterinary Office which relate to deficiencies in sanitary controls, such as in animal traceability systems and in animal movement control systems.

57. As regards point (1), namely, findings of the Food and Veterinary Office which relate to the presence of animal or human health threats in herds located in specific regions of Brazil, the Ombudsman notes that the World Organisation for Animal Health divides Brazil into zones with different foot and mouth disease statuses. These statuses are: (i) "foot and mouth disease-free 'without vaccination'"; (ii) "foot and mouth disease-free 'with vaccination'"; and (iii) "not foot and mouth disease-free". The Commission prohibits all imports of beef from all those areas of Brazil which are infected by foot and mouth disease. As such, when, on 14 October 2005, Brazil confirmed to the World Organisation for Animal Health that an outbreak of foot and mouth disease had occurred in one of the "foot and mouth-free zones", namely, Mato Grosso do Sul, the Commission[13] suspended all imports of beef from that state and from the neighbouring states of Paranᡡnd Sao Paulo for animals slaughtered after 30 September 2005[14].

58. As such, the Ombudsman understands that, as regards the evaluation of the "gravity of the situation", it is the Commission's view that the risks associated with importing beef emanating from regions in which the foot and mouth virus is present, or areas adjacent to those regions, are sufficient to justify the prohibition of imports of products of animal origin from those areas.

59. As regards point (2), namely, findings of the Food and Veterinary Office which relate to deficiencies in sanitary controls, such as in animal traceability systems or in animal movement control systems, the Ombudsman first notes that sanitary controls mechanisms are important irrespective of the presence of animal pathologies in a particular area.

60. First, sanitary controls are important because they ensure that animals and meat from areas which are infected with foot and mouth disease are not mistakenly identified as being from areas which are not infected with foot and mouth disease. They also serve to ensure that animals from areas which are infected with foot and mouth disease do not come into contact with animals from areas which are not infected with foot and mouth disease (during the transit of animals).

61. Second, while sanitary controls are vital in relation to known public health threats and known sanitary threats (such as the threat from foot and mouth disease), sanitary controls are also vital because they ensure that the public authorities are capable dealing rapidly and effectively with any emerging or future public health or sanitary threats. In particular, comprehensive traceability systems[15] and animal movement control systems not only seek to control known sanitary and/or public health threats to the food chain, such as the current threat posed by foot and mouth disease. They also ensure that the authorities are capable of dealing rapidly and effectively with any emerging or future public health or sanitary threats, by pinpointing, as soon as possible after the identification of a risk, the origin of produce, and are capable of immediately taking the necessary measures for the purpose of eliminating the risk to animal or public health[16]. In particular, traceability, which allows the competent authorities to trace a risk backwards and forwards along the food chain, is necessary for the purposes of responding to potential risks that can arise in food and feed[17].

62. As such, deficiencies in sanitary controls can justify imposing restrictions even in relation to imports of beef from those areas of Brazil where the foot and mouth virus is currently not present[18].

63. The Ombudsman notes that a "risk assessment" carried out by EFSA in relation to Brazilian beef production indicated that the "model" of sanitary measures "proposed" by the Brazilian authorities, including the measures proposed in relation to traceability and animal movement controls, were adequate. However, the Ombudsman agrees with the complainant that it is vital, especially in a context in which animal and public health is at issue, that the Commission verify that the proposed measures are actually put in place. He also notes that such verifications are vital, since any restrictions on imports, if imposed, must be based on scientific evidence in order to be legal under the SPS Agreement[19]. In sum, the Ombudsman considers that it is consistent with principles of good administration for the Commission to take all necessary steps to obtain accurate and regular scientific evidence in relation to beef which may be imported into the EU from Brazil.

64. In this respect, the Ombudsman notes that the Commission's Food and Veterinary Office has carried out regular audits of the Brazilian beef industry and produces reports in relation to such audits. The aim of the audits is to ascertain whether the competent veterinary authorities in Brazil actually apply the proposed measures. From 2005 until 2007, the Food and Veterinary Office carried out five missions to Brazil to evaluate the animal health controls in place, in particular for foot and mouth disease, and two missions to evaluate the control of residues and contaminants in live animals and animal product. This was a particularly high frequency of inspections for the Food and Veterinary Office. Given the vital importance of such missions for the protection of animal and human health in the EU, the Ombudsman considered it necessary to make a further remark below (see also paragraph 129 below).

65. The Ombudsman notes that the quantity and quality of the audits carried out by the Commission's Food and Veterinary Office have not been called into question in the context of the present inquiry. Rather, the nature of the complaint relates to the alleged failure of the Commission to take action, notwithstanding evidence obtained by the Food and Veterinary Office that such imports posed a risk to human and animal health.

66. The Ombudsman has carefully examined the report relating to the March 2007 mission. In order to produce its report, the Food and Veterinary Office assessed, in particular:

a. the Foot and Mouth Disease situation in Brazil, including regionalisation controls and other measures;

b. the implementation of the vaccination programme undertaken by the Brazilian authorities, including its coverage and efficacy;

c. the implementation of the sero-surveillance programme in all Foot and Mouth Disease susceptible species undertaken by the Brazilian authorities;

d. the certification of animals and meat in relation to the requirements of Council Directive 96/93/EEC;

e. the control and recording of animal movements, including those controls necessary for certification in accordance with the requirements of Council Decision 79/542/EEC; and

f. the controls in place over the production of fresh meat and casings.

67. The Ombudsman first notes that, while the report identified certain errors, there is no specific indication in the report itself that the errors identified in it and relating to the mission of March 2007 should be classified as "serious animal health risks" within the meaning of Article 10(4) of Council Directive 2002/99/EC.[20] In the report relating to the mission of March 2007, the Food and Veterinary Office concluded that:

"The public health control systems in place were generally satisfactory. Some remaining deficiencies were noted, e.g. in relation to actions taken in response to certain recommendations of previous reports which were incomplete ż/em>

While the certificates issued were generally well supported by national certificates and further supporting documentation, the database for certification is not completely secure against fraud.

The competent authority has started implementing a new system of approved cattle holdings which aims to create a closed system for exports to the EU from 2009 onwards. Although the concept allows for better controls, many problems were observed in the start-up phase and, regarding the transitional period, not all recommendations of the 2006 missions were satisfactorily addressed leading to doubts about the reliability of the system at present.

As regards animal health, the foot and mouth disease vaccination programme was generally implemented in a satisfactory way in the states visited. Some minor shortcomings remained in the design and supervision of the programme and the registration of vaccinated animals. No programme is foreseen for 2007 to control the efficacy of the foot and mouth disease vaccination programme, which is a matter of concern as it jeopardises future certification of beef.

During 2006/2007 targeted and general serological programmes were carried out to check for the absence of foot and mouth disease virus circulation. The (national authority) stated that results show that [the] virus is still circulating in parts of Mato Grosso do Sul. As a result, preventive slaughtering of all animals has been carried out in 2007 in farms with virus circulation.

Some shortcomings already detected in 2006 (e.g. pre-movement testing in animals moving out of the restricted area of MS to EU-approved States is not carried out, long delays between the 1st and 2nd serological control, long delays between the sampling and the laboratory results, etc) had not been adequately addressed."

These conclusions do not specifically state that the errors identified should be classified as "serious animal health risks" within the meaning of Article 10(4) of Council Directive 2002/99/EC.

68. As regards traceability, the report stated that:

"The traceability systems in place in all establishments visited were generally satisfactory[21] In one establishment visited, meat of an animal classified as non-EU eligible (for identification reasons) was exported to the EU. However, the meat of this animal was still subjected to maturation and deboning. Some official veterinarians were not familiar with the traceability system in place." (emphasis added)

These conclusions do not specifically state that the errors identified should be classified as "serious animal health risks" within the meaning of Article 10 (4) of Council Directive 2002/99/EC.

69. Concerns were raised as regards the ability of the Brazilian authorities to audit the entire Brazilian beef production system, and the consequences that such a failure would have for the system of traceability. The Ombudsman notes that the Food and Veterinary Office made the following conclusion as regards Brazil's ability to audit its entire system:

"The audits which were carried out in 2007 focussed only on the systems in place in the establishments audited by the CCA and consequently the complete chain of traceability has not been verified from establishment of export back to the holding of origin."[22] (emphasis added)

These conclusions do not specifically state that the errors identified should be classified as "serious animal health risks" within the meaning of Article 10 (4) of Council Directive 2002/99/EC.

70. As regards controls over animal movements, the report stated that:

"There is an inconsistency between the requirement for an official veterinarian to reject the whole consignment of animals for EU slaughter if a single animal in the batch does not meet the identification or residency requirements[23], and the requirement Što reject only the non-conforming animal, allowing [the official veterinarian] to accept the remainder of the batch.

The fact that not all relevant information is used prior to approval of some holdings and the requirements of NI 17/2006 by certain keepers of animals were incorrectly implemented calls into question the reliability of the 40 days residence of all cattle on those holdings and the 90 days residence in the EU approved area(s)."

These conclusions do not specifically state that the errors identified should be classified as "serious animal health risks" within the meaning of Article 10 (4) of Council Directive 2002/99/EC.

71. The Ombudsman, however, notes that Recital 2 of Commission Decision 2008/61/EC reads as follows:

"Since 2003, deficiencies with regards to Community import requirements for bovine meat have been identified during Commission missions to Brazil. Some of these deficiencies have been addressed by Brazil, but recent Commission missions have nonetheless identified serious instances of non-compliance with regard to holding registration, animal identification and movement control and a failure to respect their previous commitments to take the appropriate corrective measures." (emphasis added)

72. The wording of Recital 2 appears to indicate that the "serious instances of non-compliance" with regard to "holding registration, animal identification and movement control", which justified the imposition of restrictions on the importation of Brazilian beef, were identified in more than one mission of the Food and Veterinary Office. It is thus arguable that the deficiencies which were identified in the report on the mission of March 2007 were also sufficiently important as to be classified as "serious instances of non-compliance". However, even if this were the case, the Ombudsman again notes that Article 22 of Council Directive 97/78/EC, which lays down the principles governing the organisation of veterinary checks on products entering the EU from third countries, states that if any serious animal health or public health reason so warrants, the Commission shall adopt one of the following measures without delay, depending on the gravity of the situation:

(i) suspend imports from all or part of the third country concerned, and where appropriate from the third country of transit,

(ii) set special conditions in respect of products coming from all or part of the third country concerned,

(iii) draw up, on the basis of actual findings, requirements for appropriate checks, which may include specifically looking for risks to public or animal health and, depending on the result of those checks, increase the frequency of the physical checks.

As such, the applicable legislation does not oblige the Commission to suspend imports of beef automatically whenever there is a "serious" animal health or public health reason. Rather, the Commission can also choose, if the gravity of the situation so demands, to deal with the situation by setting special conditions or drawing up requirements for appropriate checks (see points (ii) and (iii) of Article 22 of Council Directive 97/78/EC).

73. The Commission states in its opinion that, on the basis of the March 2007 Food and Veterinary Office mission report, it asked the Brazilian authorities "to provide auditable evidence of the rectification of the remaining deficiencies by the end of the year 2007". It also stated that the Food and Veterinary Office had scheduled a further mission to Brazil for November 2007 "to ensure that those deficiencies were correctly addressed by the Brazilian authorities". It thus appears that the Commission took the third option set out in Article 22 of Council Directive 97/78/EC, namely, it drew up requirements for appropriate checks. The Ombudsman understands that the Commission took this option because it was of the view that the "gravity of the situation" was not such as to warrant the imposition of stricter measures, such as a suspension of beef imports from Brazil.

74. The Ombudsman has consistently stated that, whenever an institution is faced with a margin of discretion, he will only find maladministration if there is a manifest error of appreciation in relation to the exercise of that margin of discretion. In this respect, the Commission has explained, in its opinion to the Ombudsman, that certain shortcomings were indeed identified during the March 2007 Food and Veterinary Office mission, but that these shortcomings were not of a nature that would justify an immediate import restriction.

75. With respect to this position, the Ombudsman observes that, while inadequacies were certainly identified after the March 2007 mission, the Food and Veterinary Office stated the following in relation to that mission:

"The public health control systems in place were generally satisfactory"

"As regards animal health, the foot and mouth vaccination programme was generally implemented in a satisfactory way in the states visited."

"The traceability systems in place in all establishments visited were generally satisfactory."

The most serious errors identified after the March 2007 mission related to the inability of the Brazilian authorities to audit the entire Brazilian system of sanitary controls. The Ombudsman notes that to require the Brazilian authorities to carry out appropriate checks for the purposes of remedying those errors does not constitute a manifest error of assessment on the part of the Commission.

76. The Ombudsman also recalls that the first allegation is that the European Commission failed, by the date of the submission of the complaint to the Ombudsman, that is, 6 July 2007, to take action required of it under EU law when it refrained from banning beef imports into the European Union from Brazil, notwithstanding evidence that such imports posed a risk to human and animal health. As such, the fact that the Food and Veterinary Office found abundant evidence of serious deficiencies during its mission to Brazil in November 2007, which led it to impose limitation on imports of beef from Brazil[24], cannot be taken into consideration when evaluating the first allegation. This would also be the case even if it could be deduced, from evidence obtained in November 2007, that certain serious deficiencies were longstanding. Likewise, the fact that Commission Decision 2008/61/EC, which was taken in January 2008 in response to the report of the November 2007 mission to Brazil, led to immediate action by the competent Brazilian authorities, cannot imply that the Commission can be faulted for not having imposed restrictions on the importation of beef from Brazil earlier. This is because the Commission can only impose restrictions on the basis of evidence available to it at the time it imposes such restrictions.

77. In sum, having reviewed carefully the report relating to the March 2007 mission, the Ombudsman cannot identify any manifest error of appreciation in relation to the position taken by the Commission at that time.

78. The Ombudsman therefore finds no maladministration in relation to the first allegation.

B. The allegation that the Commission, having received the Final Report from the Food and Veterinary Office regarding the Food and Veterinary Office's November 2007 mission to Brazil, failed to act reasonably and proportionately, in order to deal with the threat to animal and public health

Arguments presented to the Ombudsman

79. While the complainant welcomed the adoption of Decision 2008/61/EC of 17 January 2008, it noted that beef certified prior to 31 January 2008 would still be allowed to enter the EU until 15 March 2008. The complainant considered this an inexplicable facilitation of the Brazilian beef sector, despite the Commission's formal admission by the Commission that there were serious instances of non-compliance in Brazil. The complainant argued that this toleration by the Commission of a seriously deficient system in Brazil was similar to past failures of the Commission to ban the imports of Brazilian beef or to confine exports to herds that fully meet EU import requirements.

80. The complainant noted that, in its press release of 19 December 2007, the Commission admitted that the Food and Veterinary Office inspection in November 2007 had identified a number of serious and repeated deficiencies in Brazilӳ animal and traceability system. The complainant argued that, given the nature of foot and mouth disease, any prudent administration would have imposed a complete ban as a result of a finding of serious deficiencies.

81. The complainant noted that the Commission had also made the same admissions in Recital (2) of Commission Decision 2008/61/EC, namely: (i) deficiencies with regard to EU imports, which were known to the European Commission since 2003; (ii) recent serious incidences of non-compliance; and (iii) an admission that the Brazilian Authorities failed to respect their previous commitments to take appropriate action. The complainant noted that these statements were evidence of the Commissionӳ failure to act and avoid a delay in taking the action required by EU law. It argued that this admission was per se evidence of maladministration committed by the Commission.

82. It also argued that, if the Food and Veterinary Office mission of November 2007 found materially different and more serious deficiencies, distinct from a continuation of previously recorded deficiencies, this should in no way exonerate the Commission from a finding of maladministration for its delay in taking action.

83. The complainant highlighted that it is important that citizens and businesses of the European Union are assured that the Commission is implementing EU law and will be held accountable for its failures to act or delays in acting.

84. On 11 April 2008, the European Commission published the Final Report of a mission carried out in Brazil from 6 to 9 November 2007 in order to evaluate animal health controls in place, in particular, regarding foot and mouth disease and public health control systems and certification processes. As the report was directly related to arguments made in the complainant's observations of 31 January 2008, the latter informed the Ombudsman's services on 16 April 2008 that it wished to make additional observations in light of the recent publication of the Final Report. The Ombudsman agreed to this request.

85. On 30 May 2008, the complainant sent further observations. In its further observations, the complainant noted that the November 2007 report disclosed new findings and contained new information not provided in previous Food and Veterinary Office reports. These findings pointed to the Food and Veterinary Officeӳ concerns over serious structural problems concerning the way in which protection mechanisms were being implemented in Brazil.

86. The complainant provided a detailed summary of the Food and Veterinary Officeӳ concerns listed in the November 2007 report. These included the lack of documentation in the head office of the Brazilian veterinary authority, failures of the approval and supervision of holdings, concerns in terms of movement controls, breaches of EU rules in some slaughterhouses, poor management and auditing of the national cattle database, and failures in the certification procedures.

87. The complainant noted that the Food and Veterinary Officeӳ November 2007 report had concluded that the performance of the Brazilian Accredited Certifying Bodies was not effective. The complainant also noted that the Food and Veterinary Office had stated that sufficient concerns existed in respect of approval and supervision of holdings to the extent that there had been a fraudulent use of ear tags in order to circumvent the 90/40 days residence rule. Furthermore, the Food and Veterinary Office stated that "the current official control of movements does not serve to re-enforce the guarantee that animals from non-approved areas are excluded from slaughter for EU export and is not reliable for the 90/40 days residence rule." Referring to the national cattle database, the Food and Veterinary Office concluded that it "contains significant inaccuracies Š[which] undermine the guarantees supplied by (the database) to support EU certification requirements". Finally, the Food and Veterinary Office noted that the "audits carried out by the CCA failed to identify major problems of the system."

88. The complainant noted that, while the March 2007 report clearly identified shortcomings and inadequacies in the system, the November 2007 report disclosed new information in respect of the "structural weaknesses" in the mechanisms used in Brazil to comply with EU law. The complainant provided a detailed summary of the concerns listed in the November 2007 report. These included:

  • the lack of documentation, in the head office of the Brazilian Accredited Certifying Bodies, of the approval and supervision of farms;
  • concerns in relation to animal movement controls;
  • breaches of EU rules in some slaughterhouses;
  • poor management and auditing of the national cattle database[25]; and
  • failures in certification procedures.

89. The complainant specified that the November 2007 report concluded that the Brazilian Accredited Certifying Bodies were not effective. The report also indentified concerns in respect of the approval and supervision of farm holdings and of a fraudulent use of ear tags in order to circumvent the 90/40 days residence rule. Furthermore, the report stated that the current official control of movements does not serve to reinforce the guarantee that animals from non-approved areas are excluded from slaughter for EU export and is not reliable for the 90/40 days residence rule. In reference to the national cattle database, the Food and Veterinary Office concluded that it "contains significant inaccuracies Š[which] undermine the guarantees supplied Što support EU certification requirements." Finally, the Food and Veterinary Office noted that the audits carried out by the Brazilian authorities failed to identify major problems of the system.

90. The complainant concluded that the November 2007 report identified a significantly and materially worse situation than had been identified in the March 2007 report. The complainant then repeated its original allegation and put forward the following arguments.

a. The Food and Veterinary Office reports disclosed systemic failures in Brazil to such an extent that the Commission could not lawfully determine that the 90/40 residence rule was being applied. The admission of Brazilian beef into the EU was therefore unlawful.

b. In light of the Food and Veterinary Office reports, and in the absence of alternative evidence, the Commission wrongfully exercised its discretion.

c. The Commission failed to give reasons for the exercise of its discretion in admitting Brazilian beef into the EU market despite evidence contained in the Food and Veterinary Office reports.

d. Having received the Food and Veterinary Officeӳ reports, the Commission failed to act reasonably and proportionately in light of the threat to animal and public health; in addition, the Commissionӳ Decision 2008/61/EC constituted an unreasonable and disproportionately small response to the health threat identified by the Food and Veterinary Office reports.

e. In light of the Food and Veterinary Office reports, the Commission misused its powers or lacked the competence to introduce Brazilian beef in the list of Annex II of Council Decision 79/542/EC, as amended.

f. Alternatively, in light of the Food and Veterinary Office reports, the Commission delayed taking the necessary actions to protect animal and public health until its Decision 2008/61/EC.

91. The complainant noted that, while the March 2007 report clearly identified shortcomings and inadequacies in the system, the November 2007 report disclosed new information in respect of the structural weaknesses in the mechanisms used in Brazil to comply with EU law. Therefore, there was a significant difference in the analysis contained in the two Food and Veterinary Office reports. The complainant noted that the identification of items not "adequately addressed" in the March 2007 report was qualitatively different from the analytic conclusion of "systemic failures" identified in the November 2007 report.

92. In light of this conclusion, the complainant alleged that it was not clear whether the Commission took into account the findings of the November 2007 report in its Decision 2008/61/EC.

Further inquiries

93. On 12 September 2008, the Ombudsman made further inquiries. In his letter to the Commission, he noted that the complainant had, in its further observations of 30 May 2008, made an additional allegation, namely, that the Commission, having received the Final Report from the Food and Veterinary Office concerning the latter's November 2007 mission to Brazil, failed to act reasonably and proportionately to deal with the threat to animal and public health. In his letter, the Ombudsman noted that the complainant had argued that Decision 2008/61/EC constituted an unreasonable and disproportionately small response to the threat to animal health identified in the Final Report. He asked the Commission to confirm whether full reports of audits and inspections have been made available to it in relation to all holdings in Brazil authorised to export bovine meat to the EU.

94. In his letter to the Commission the Ombudsman asked the latter to confirm if it carried out, or planned to carry out, inspections to verify that the EU import requirements are being met in relation to the holdings authorised to export bovine meat to the EU.

Arguments presented to the Ombudsman: The Commission's opinion

95. The Commission noted that, in accordance with the principles of the SPS Agreement, the limits imposed on the importation of beef from Brazil must be science-based, proportionate and non-discriminatory. It also recalled that the Food and Veterinary Office verifies, through inspections, that the European Union import requirements are met. In November 2007, the Food and Veterinary Office identified "serious instances of non-compliance" with EU import requirements for bovine meat in Brazil with regard to (1) holding registration, (2) animal identification and (3) movement control, and a failure by Brazil to respect previous commitments to take the appropriate corrective measures. Following these findings, Commission Decision 2008/61/EC restricted imports of Brazilian beef to ensure the "effective control and surveillance" of holdings from which animals eligible for export to the EU could be sourced. In accordance with the Decision, Brazilian holdings able to export beef to the EU would have to meet a number of requirements, which included the identification and registration of all animals in the national Brazilian system for bovine animals, and their being placed under the effective control of the Brazilian veterinary services. In order to ensure compliance with those conditions, the Brazilian authorities were required to provide the Commission with a list of eligible holdings, as well as audit and inspection reports demonstrating that all EU requirements are being met. The Commission should then make the list of holdings publicly available. The Food and Veterinary Office was entitled to verify that the listed holdings met EU import requirements by carrying out inspections in Brazil.

96. Following the entry into force of the Decision, imports to the EU fell to very low levels. As of 9 October 2008, 412 Brazilian bovine holdings were listed as authorised for the export of bovine meat to the EU. Previously, an estimated 10,000 holdings were eligible for export to the EU. Full reports of audits and inspections have been made available to the Commission in relation to all these 412 holdings in Brazil currently authorised to export bovine meat to the EU. These measures have had a serious impact on trade. During the period from April to August 2008, a total of 3 294 tonnes of Brazilian beef was imported into the EU, whilst, during the same period of 2007, 102 470 tonnes were imported.

97. Between 27 February and 13 March 2008, the Food and Veterinary Office carried out an inspection of a selection of listed holdings to verify that all EU requirements were being met. The findings of this mission did not justify any further immediate action in relation to imports of beef from Brazil. The report of this mission was published on 24 September 2008. A further Food and Veterinary Office inspection to Brazil was scheduled to take place before the end of 2008, to verify the compliance of the listed Brazilian holdings with EU requirements.

98. During April 2008, at the request of the Brazilian authorities, officials from DG SANCO provided training in Brazil on traceability and on the auditing of holdings, in order to ensure a better understanding of EU requirements.

99. As regards, specifically, the allegation that, having received the Final Report, the Commission failed to act reasonably and proportionately in light of the perceived threat to animal and public health, the Commission did not agree that there was a valid argument that would substantiate the allegation that the Commission failed to act in accordance with the rules or principles binding upon it. It noted that the Food and Veterinary Office inspection in Brazil in November 2007 did not identify findings that would justify the "complete banning" of Brazilian beef imports. The measures adopted in Commission Decision 2008/61/EC were considered necessary to ensure that EU import requirements were being met, whilst allowing compliant trade to remain open, in line with WTO rules. These measures have had a serious impact on trade, but the Commission believes the actions it took were proportionate and non-discriminatory.

100. To conclude, the Commission believed that, in considering and managing the potential risks associated with the import of beef from Brazil, it acted in accordance with the rules and principles which are binding upon it and, in addition, followed technically sound scientific principles in accordance with international standards. Moreover, the Commission imposed severe restrictions on imports of beef from Brazil in January 2008, and these measures have had a serious impact on trade.

101. In addition, it stated that, since the establishment of the EU import policy in the animal health area in 1972, foot and mouth disease has never been caused by legally introduced consignments allowing deboned and matured bovine meat from countries where vaccination against foot and mouth disease has been carried out. In fact, it stated that the last outbreak was as a result of a leak from a UK laboratory handling the foot and mouth disease virus.

Arguments presented to the Ombudsman: The complainant's observations

102. The complainant recalled its statement that the November 2007 Food and Veterinary Office Mission Report set out "serious structural concerns" in respect of animal movement, approval and supervision of holdings, the national cattle database and certification procedures. It expressed the view that the "systemic failures" identified in the November 2007 report represented a deteriorated situation from the March 2007 report. The Food and Veterinary Office conclusions confirmed the concerns the complainant had previously expressed in its own reports. It noted that Commission Decision 2008/61/EC did not identify how the measures undertaken propose specifically to address the systemic failures identified by the Food and Veterinary Office. It expressed the view that the structural weaknesses in the necessary protection mechanisms for compliance with EU law were such that no action short of a (full) ban could fully protect animal and public health in the EU. It concluded that, in light of the Food and Veterinary Office evidence of "systemic failures", the Commission cannot lawfully determine that the 90/40 residence rule is being applied, and that, as a consequence, the admission of Brazilian beef into the EU is itself unlawful. The complainant stated that, in the absence of any alternative evidence, the Commission has wrongfully exercised its discretion in permitting the entry of Brazilian beef onto the EU market through Commission Decision 2008/61/EC. It argued that the Commission failed to give reasons for not imposing the ban in the context of overwhelming evidence supporting a ban. In its opinion, this must lead to the conclusion that issues which should be irrelevant to animal and public health were taken into consideration. It also stated that the Commission failed to take into account the Food and Veterinary Office Mission Report's conclusions, and therefore breached the complainant's legitimate expectations and misused its powers.

103. Finally, and alternatively, it concluded that, given the strong evidence in the previous Food and Veterinary Office Mission Reports, the Commission unreasonably and unnecessarily delayed taking the necessary action to protect animal and human health, which it belatedly took in Commission Decision 2008/61/EC. It argued that the Commission effectively permitted ֠for an egregious period until Commission Decision 2008/61/EC was adopted ֠the circulation of substandard and illegal Brazilian beef within the EU. The integrity of the beef supply to the EU market has therefore not yet been ensured. Accordingly, it cannot be established that Commission Decision 2008/61/EC was an "appropriate and proportionate" legal response to the November 2007 Food and Veterinary Office report.

104. The complainant submits that it is a duty of good administration to give reasons, and that, accordingly and in the first place, the onus is on the Commission to justify the actions taken in Commission Decision 2008/61/EC and the reasons why a ban would be inappropriate. It argues that the Commission continues to fail to give reasons why a ban would be inappropriate in circumstances where the facts identified by its own authorities manifestly require the strongest remedial action.

105. Moreover, in light of the strength of the findings in the November 2007 report, and in particular of the ongoing failings detected in the March 2008 report, the complainant submitted that no action short of an outright ban could ensure fully compliant trade with the EU. In the complainant's view, no WTO rules would be infringed by such a ban.

The Ombudsman's assessment

106. The Ombudsman notes that the Food and Veterinary Office report on the mission of November 2007 categorises certain deficiencies in the Brazilian system of sanitary controls as "serious". The complainant itself argues that the Food and Veterinary Office mission of November 2007 found deficiencies that were materially different and more serious than the deficiencies previously recorded.

107. The Ombudsman notes that, as regards traceability, the November 2007 report of the Food and Veterinary Office mission concluded that:

"In 2 establishments visited (by the Food and Veterinary Office inspectors) serious failures in the traceability system were detected, which had not been identified by the (Brazilian authorities). These establishments were de-listed during the mission at the request of the mission team."

108. The November 2007 report of the Food and Veterinary Office mission also identified systemic failures. It noted that:

"The performance of the Accredited Certifying Bodies is not effective. Accredited Certifying Bodies failed to identify major shortcomings in animal identification and animal movement, and failed to up-date the SISBOV database."

"The checks carried out by Accredited Certifying Bodies prior to approval or re-inspections are inadequate to detect discrepancies or to confirm the reliability of the data. Consequently, data available in the SISBOV system do not reflect the actual number of the cattle present on the Šholdings in a significant number of cases. Moreover, serious deficiencies were identified on 3 out of the 10 Šholdings visited. These deficiencies would allow the fraudulent use of SISBOV ear tags in order to circumvent the 90/40 days residence rule."

"The current official control of movements does not serve to re-enforce the guarantee that animals from non-approved areas are excluded from slaughter for EU export and is not reliable for the 90/40 days residence rule."

"In one slaughterhouse visited however, batches were incorrectly declared as EU eligible in some cases."

"The new SISBOV database functions efficiently as an IT system but the database already contains significant inaccuracies because of the deficiencies Šas well as the poor quality of data supplied by Accredited Certifying Bodies and the lack of plausibility tests. These inaccuracies undermine the guarantees supplied by SISBOV to support EU certification requirements."

"Although criteria to identify participants to be audited have been established, these did not take into account the most critical points of the SISBOV system. The audits carried out Šfailed to identify major problems of the system."

109. It concluded, in relation to all of the above, that:

"Systemic failures were identified in relation to holding registration, animal identification and movement controls. The situation in relation to holding registration, animal identification and movement control is such that the Brazilian authorities cannot provide the guarantees in respect of residency in approved areas and on approved holdings required by the European Union."

110. The Ombudsman again recalls that a third country can only appear on the list of countries entitled to export meat to the EU if an EU audit of that country has taken place and demonstrates that the competent veterinary authority provides "appropriate guarantees" as regards compliance with EU legislation. The Ombudsman understands that "appropriate guarantees" refer to the need for the third country to demonstrate that it has taken all measures "necessary to safeguard animal health". He again recalls that Article 10 of Council Directive 2002/99/EC states that if a "serious animal health risk" is identified during an EU inspection or audit, the Commission shall immediately take "the measures necessary to safeguard animal health". He also again recalls that Article 53 of Regulation 178/2002 states that:

"Where it is evident that food or feed originating in the Community or imported from a third country is likely to constitute a serious risk to human health, animal health or the environment, and that such risk cannot be contained satisfactorily Ŭ the Commission Šshall immediately adopt one or more of the following measures, depending on the gravity of the situation: ż/em>

(b) in the case of food or feed imported from a third country:

(i) suspension of imports of the food or feed in question from all or part of the third country concerned and, where applicable, from the third country of transit;

(ii) laying down special conditions for the food or feed in question from all or part of the third country concerned;

(iii) any other appropriate interim measure."

It is clear from the above that the nature and extent of measures adopted to deal with a specific serious threat to animal or public health resulting from products of animal origin imported into the EU from third countries will depend on the "gravity of the situation" relating to animal health in the third country concerned. In sum, while the Commission is empowered to suspend the importation of animal products from all or part of a third country, it may also, if the risks to animal and human health are deemed to be less intense, impose less onerous measures. These less onerous measures include setting "special conditions" in respect of products from the third country or drawing up "requirements for appropriate checks".

111. The "serious inadequacies" identified after the November 2007 mission to Brazil did not give rise to a ban on beef imports from Brazil, but rather led the Commission to impose "special conditions" as regards the importation of beef from Brazil. The special conditions essentially require the Brazilian competent authorities to implement a system of approved cattle holdings which would create a closed system of holding authorised to export to the EU. The Ombudsman notes that these conditions essentially brought forward in time a project which had already been put forward for the Brazilian beef industry[26].

112. The Ombudsman notes the complainant's argument that there is an onus on the Commission to justify why a ban would be inappropriate (in sum, the Ombudsman understands the complainant to argue, the Commission should impose a ban unless it can show that the ban would be inappropriate). The Ombudsman disagrees. Rather than having an onus to justify why a ban would be inappropriate, the Commission is legally required, if it is to impose a ban, to justify why a ban would be appropriate. In sum, the burden of proof is on the Commission whenever it imposes restrictions on imports. In this context, he notes that, in accordance with the principles of the SPS Agreement, restrictions imposed on importation must be science-based, proportionate and non-discriminatory.

First branch of the SPS test - restrictions must be science-based

113. As regards the first branch of the test, namely the requirement that any restrictions be science-based, the Ombudsman notes that EFSA provided the Commission with independent scientific advice on the protective mechanisms developed by the EU to reduce the risk of the introduction of foot and mouth disease into the EU. The Ombudsman understands that EFSA took the view that the protective mechanisms developed by the EU were necessary to reduce the risk of foot and mouth disease entering the EU.

Second branch of the SPS test - restrictions must be proportionate

114. As regards the second branch of the test, namely, the requirement that any restrictions be proportionate, the Ombudsman notes that the concept of proportionality implies that a measure must, cumulatively, be:

a. suitable;

b. necessary; and

c. proportionate (in the strict sense).

115. The first criterion within the proportionality test, namely the "suitability" criterion, requires that there be a causal relationship between the measure imposed and the results of taking that measure.[27] Measures which do not achieve the objective that they propose to achieve will not meet this test.

116. It is clear that a ban on imports of beef from Brazil would meet the "suitability" criterion, insofar as a ban would certainly eliminate any animal or public health risks resulting from the importation of Brazilian beef.

117. As regards whether the requirement that beef can only be imported from "approved holdings" also meets this "suitability" criterion, the Ombudsman notes that the authorised holdings were only accepted by the Commission after it received full reports of audits and inspections in relation to all the approved holdings[28]. He also notes that the Food and Veterinary Office evaluated the effectiveness of the approval and inspection procedures relating to these holdings by inspecting a sample of 27 of the listed holdings in 5 different Brazilian States. The Brazilian authorities nominated and trained auditors to carry out audits in "approved holdings". It was also concluded at the end of the Food and Veterinary Office mission in February-March 2008 that the EU requirements were being met in the audited and approved holdings[29]. A further Food and Veterinary Office inspection to Brazil was scheduled to take place before the end of 2008, to verify the compliance of the listed Brazilian holdings with EU requirements[30]. It is thus clear that the special conditions imposed also met the "suitability" criterion.

118. The second criterion within the proportionality test, namely, the "necessity" criterion, precludes the imposition of a measure when there is an alternative, less restrictive measure that also achieves the same objective (which is to protect animal and public health). As the three criteria of the proportionality test are cumulative, the criterion must also be met before the EU is permitted to impose a measure restricting trade. The imposition of special conditions, which prohibit beef imports unless the cattle come from "approved holdings", achieves the same objective as a complete ban on imports of beef from Brazil (see paragraph 117 above). The special conditions are clearly less onerous than a complete ban. Faced with a choice between two options, namely, a ban or the imposition of special conditions, both of which are "suitable" to achieve the stated objective (which is to protect animal and public health), the Commission was legally obliged to choose the less onerous measure.

119. The Ombudsman again underlines that the three criteria of the proportionality test are cumulative; that is, all three criteria must be met by a measure if it is to comply with the test. As such, a complete ban on imports of beef from Brazil would not meet the proportionality test given that it would fail to meet the second criterion of that test.

120. Given that the three aspects of the proportionality test are cumulative, and given that a complete ban would not meet the second part of this test, there is no need to examine in detail, at this stage,[31] the third part of the proportionality test (which is the criterion that a measure must be proportionate in the strict sense). It suffices to note that proportionality, in the strict sense, requires an analysis of whether a measure is excessive in relation to the various interests concerned.

Third branch of the SPS test - restrictions must be non-discriminatory

121. The requirement that any measures restricting trade in animal products be non-discriminatory implies that the Commission cannot treat imports of animal products more restrictively than it treats trade in animal products within the EU. In this respect, the Ombudsman notes that not every shortcoming in systems of control within the EU gives rise, automatically, to a ban on the trade in products from the area concerned[32]. When the Food and Veterinary Office identifies shortcomings within the EU, the Commission has, in addition to the option of imposing a ban, the option to require that appropriate measures be taken to deal with the shortcomings or the option to impose special conditions. The choice as regards which specific remedy to impose must always be based on the gravity of the situation. It is not discriminatory, in the Ombudsman's view, for the Commission to act in an identical manner as regards imports from third countries.

122. The Ombudsman also notes that agricultural holdings within the EU can be prohibited from trading in animal products unless they meet EU sanitary requirements. In this context, the Ombudsman is of the view that it is not discriminatory, under the SPS Agreement and the applicable EU rules, to ban imports of animal products into the EU when these products come from non-approved holdings. As such the measures which were imposed through Commission Decision 2008/61/EC were not discriminatory. However, the same conclusion may not hold true if a ban had also been imposed in relation to imports of animal products into the EU, when these products come from fully audited and approved holdings located in areas which, after scientific analysis, are deemed to be foot and mouth free (with or without vaccination).

123. The Ombudsman again underlines his consistent view that, whenever an institution is faced with a decision allowing it to exercise a margin of discretion, he will only find maladministration if there is a manifest error of appreciation in relation to the exercise of that margin of discretion. In light of the above findings, the Ombudsman does not consider that there was a manifest error by the Commission when, in response the serious deficiencies identified in the report on the mission of November 2007, it imposed specific conditions as regards the importation of beef from Brazil, rather than a full suspension of imports of beef from Brazil. As such, he finds that there was no maladministration as regards this aspect of the allegation.

124. The complainant has also argued that the Commission erred by delaying the adoption of restrictions relating to the importation of beef from Brazil.

125. First, the Ombudsman observes that, given the nature of the serious deficiencies identified by the Food and Veterinary Office inspections of November 2007 (namely, lack of traceability, lack of animal movement controls ũ, it cannot, in any way, be excluded that the serious deficiencies identified may have existed even prior to November 2007. Such an understanding would be reinforced by the fact that, once the Brazilian authorities were requested to provide full reports of audits and inspections with a view to establishing a list of "approved holdings" in January 2008, the Brazilian authorities were only able to identify 412 holdings (out of the approximately 10,000 holdings that were previously authorised for export to the EU). However, as noted above, the Commission was, in accordance with the legal rules binding upon it, only permitted to impose restriction measures, such as the imposition of specific conditions, once it had the necessary evidence which would justify the imposition of such restrictions. The Commission only obtained that evidence as a result of the inspection of November 2007. As such, the Commission cannot be faulted for delaying to impose the restrictions prior to its analysis of the report of the Food and Veterinary Office following its inspections of November 2007. As such, he finds that there was no maladministration as regards this aspect of the allegation.

126. However, the Ombudsman notes that the Commission did not immediately impose the special conditions as regards all imports of beef from Brazil once it had analysed the report of the November 2007 mission. Rather, it allowed consignments of meat, for which veterinary certificates were issued prior to 31 January 2008 and which were "en route" to the EU at that date, to be imported into the EU until 15 March 2008. He notes that its decision states that the purpose of the exception was to "avoid disruption of trade".[33]

127. The Ombudsman surmises that the reason that such an exception was allowed as regards beef en route to the EU by 31 January 2008 was because the Commission sought to balance conflicting interests. These interests were 1) the interest in putting in place measures to deal with the risks associated with the serious deficiencies (now identified) in relation to the Brazilian beef production system, and 2) the interest in avoiding costs that would be incurred by refusing entry into the EU of consignments of meat that were already en route to the EU. Such a balancing of interests would structurally fall within the analysis of proportionality in the strict sense[34]. It is recalled that proportionality in the strict sense requires that a restriction should not be excessive in relation to the interests concerned[35].

128. The Ombudsman considers, however, that when the Commission balances conflicting interests (and the only explanation for permitting, until 15 March 2008, certain imports of beef from outside the approved holding was that such a balancing exercise was, in fact, carried out), that balancing exercise should be properly reasoned and not simply announced. The Ombudsman notes that the Commission has not, in any way evident to the Ombudsman, quantified the costs in question, namely, the costs of disrupting trade and the costs associated with incurring the (now verified) risks associated with the importation of beef emanating from outside the approved holdings. It did not explain how the costs of disrupting trade might outweigh the (now verified) risks associated with the importation of beef emanating from outside the approved holdings.[36] In this context, the Ombudsman will make a critical remark as regards this aspect of the allegation.

129. The Ombudsman is fully aware of the need to provide the highest possible level of protection for human and animal health in the EU. He is also fully cognisant of the dangers posed by sanitary threats, such as foot and mouth disease. Given that the applicable legal rules only entitle the EU to impose restrictions on imports into the EU, for the purposes of protecting human and animal health and when there is science-based evidence to justify such restrictions, it is clearly important that the Commission continues to conduct regular and thorough systematic checks to ensure that third countries not only propose, but also adopt and keep in place adequate sanitary controls. Adequate sanitary controls should provide at least an equivalent level of protection as is provided within the EU. In this context, the Ombudsman will make a further remark below.

C. The claim that the Commission should impose a ban on the importation of Brazilian beef

130. The complaint was submitted prior to the adoption of Commission Decision 2008/61/EC in which the Commission imposed special conditions in relation to the importation of beef produced in Brazil into the EU. Notwithstanding the delay in applying such special conditions to beef produced in Brazil (see paragraph 128 above), these special conditions were fully applied after 15 March 2008. Furthermore, in light of the conclusions reached in paragraph 78 concerning the first allegation and paragraphs 123 to 125 concerning the second allegation, the claim cannot be sustained.

D. Conclusions

As regards the allegation that the European Commission failed, by the date the complaint was submitted to the Ombudsman, to take action required of it under EU law, when it refrained from banning beef imports into the European Union from Brazil, notwithstanding evidence that such imports posed a risk to human and animal health, there was no maladministration by the Commission.

As regards the allegation that the Commission, having received the Final Report from the Food and Veterinary Office in relation to the Food and Veterinary Office's November 2007 mission in Brazil, failed to act reasonably and proportionately to deal with the threat to animal and public health, the Ombudsman concludes that there was no maladministration by the Commission when, rather than imposing a complete ban on imports of all Brazilian beef, it imposed special conditions, whereby beef could only be imported from approved holdings.

However, as regards beef in transit from 1 February 2008 until 15 March 2008, the Ombudsman makes the following critical remark:

The Commission failed to justify adequately why it permitted, between 1 February 2008 and 15 March 2008, imports of consignments of beef from Brazil into the EU.

As regards the claim that the Commission should impose a ban on the importation of Brazilian beef, the claim cannot be sustained.

The complainant and the Commission will be informed of this decision.

FURTHER REMARK

The Commission should continue to conduct regular missions to third countries for the purposes of carrying out systematic checks to ensure that such countries not only propose, but also adopt and keep in place adequate sanitary controls. Adequate sanitary controls should provide at least an equivalent level of protection as is provided within the EU.

 

P. Nikiforos DIAMANDOUROS

Done in Strasbourg on 12 July 2010


[1] The World Organisation for Animal Health has categorised foot and mouth disease as a "list A" disease. List A diseases are defined by the World Organisation for Animal Health as transmissible diseases which:

- have the potential for very serious and rapid spread, irrespective of national borders;

- are of serious socio-economic or public health consequence;

- are of major importance in the international trade of animals and animal products.

[2] Data updated on 20 February 2009.

[3] Namely, Santa Catarina.

[4] Brazil is a federation composed of twenty-six States and one federal district (which contains the capital, Brasa).

[5] The Food and Veterinary Office is a Directorate of the Commission's Directorate-General for Health and Consumer Protection (known as DG SANCO).

[6] The European Commission published the Final Report on 11 April 2008.

[7] Council Decision of 21 December 1976 drawing up a list of third countries from which the Member States authorize imports of bovine animals, swine and fresh meat (Official Journal L 146, 14 June 1979, pages 15ֱ7).

[8] Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (Official Journal.. L 31, February 2002, pages 1-24).

[9] The Ombudsman notes that the opinion was sent to him on 10 December 2007. However, given the statements made in the opinion, he understands that the opinion was drafted sometime prior to the November 2007 mission to Brazil.

[10] However, while products can never be authorised if they come from a holding which is infected or suspected of being infected, the production, processing and distribution of products of animal origin may come from a territory or part of a territory subject to animal health restrictions provided that:

(i) The products undergo treatment enabling the animal health problem concerned to be eliminated;

(ii) The treatment is applied at an establishment approved for that purpose by the Member State in which the animal health problem occurred;

(iii) The products which are to undergo treatment are clearly identified; and

(iv) Before being subjected to the treatment referred to above, the products have been obtained, handled, transported and stored separately, or at different times, from products fulfilling all the animal health conditions, and the conditions for transport out of the territory subject to animal health restrictions have been approved by the competent authority.

[11] When drawing up or updating those lists, particular account shall be taken of:

(a) The legislation of the third country;

(b) The organisation of the competent veterinary authority and its inspection services in the third country, the powers of these services, the supervision to which they are subject, and the means at their disposal, including staff capacity, to apply their legislation effectively;

(c) The actual animal health requirements applying to the production, manufacture, handling, storage and dispatch of products of animal origin intended for the EU;

(d) The assurances which the competent veterinary authority of the third country can give regarding compliance or equivalence with the relevant animal health conditions;

(e) Any experience of marketing the product from the third country and the results of any import controls carried out;

(f) The results of EU inspections and/or audits carried out in the third country, in particular, the results of the assessment of the competent authorities or, where the Commission so requests, the report submitted by the competent authorities of the third country on the inspections which they have carried out;

(g)The health status of livestock, other domestic animals and wildlife in the third country, with particular regard to exotic animal diseases and any aspects of the general health situation in the country which might pose a risk to public or animal health in the EU;

(h) The regularity, speed and accuracy with which the third country supplies information on the existence of infectious or contagious animal diseases in its territory, particularly the notifiable diseases listed by the World Organisation for Animal Health;

(i) The rules on the prevention and control of infectious or contagious animal diseases in force in the third country and their implementation, including rules on imports from other countries.

[12] The Ombudsman understands that a measure which is based solely on science will, by its very nature, be proportionate. As regards the requirement that a measure be non-discriminatory, the Ombudsman understands that this requirement implies that the restrictions imposed on imports from third countries can be no stricter than the restrictions imposed as regards trade in products within the EU. It should also avoid discrimination between third countries.

[13] See Food and Veterinary Office report 2006-8301 relating to a mission to Brazil in January-February 2006 and published in December 2006. The mission was undertaken in response to 34 outbreaks of Foot and Mouth Disease notified in Mato Grosso do Sul and Paranᡳince October 2005.

[14] Imports of deboned meat were permitted from the remaining foot and mouth-free zones of Brazil. On 29 July 2008, the Scientific Commission of the World Organisation for Animal Health recognised that the State of Mato Grosso do Sul should regain its status of "foot and mouth disease free 'with vaccination'".

[15] As regards the scope of traceability requirements, the Ombudsman notes that Article 18 of Regulation 178/2002 states that: "The traceability of food, feed, food-producing animals, and any other substance intended to be, or expected to be, incorporated into a food or feed shall be established at all stages of production, processing and distribution." Further, Recital 29 of Regulation 178/2002 also states that: "It is necessary to ensure that a food or feed business including an importer can identify at least the business from which the food, feed, animal or substance that maybe incorporated into a food or feed has been supplied, to ensure that on investigation, traceability can be assured at all stages."

[16] Indeed, the decision to ban all imports of beef from the state of Mato Grosso do Sul, and from the neighbouring states of Paranࡡnd Sao Paulo, following the foot and mouth outbreak in October 2005, could only have been achieved if the adequate traceability mechanism were already in place before the outbreak. Indeed, the Ombudsman notes that while the outbreak was only confirmed on 15 October 2005, the Commission banned imports of beef from all animals from those zones slaughtered after 30 September 2005.

[17] Recital 28 of Regulation 178/2002 states that "[e]xperience has shown that the functioning of the internal market in food or feed can be jeopardised where it is impossible to trace food and feed. It is therefore necessary to establish a comprehensive system of traceability within food and feed businesses so that targeted and accurate withdrawals can be undertaken or information given to consumers or control officials, thereby avoiding the potential for unnecessary wider disruption in the event of food safety problems."

[18] The Ombudsman notes that the justifiable lack of public confidence in beef which would result from a failure to ensure that necessary guarantees are in place in relation to beef imported into the EU could also have serious negative effects on all EU producers of beef, due to a fall of general public confidence in the food chain and even though such EU producers do comply with strict EU requirements as regards the production of beef.

[19] As regards beef imports into the EU, the SPS Agreement reads, in Article 2, as follows:

"1.Members have the right to take sanitary and phytosanitary measures necessary for the protection of human, animal or plant life or health, provided that such measures are not inconsistent with the provisions of this Agreement.

2.Members shall ensure that any sanitary or sanitary measure is applied only to the extent necessary to protect human, animal or plant life or health, is based on scientific principles and is not maintained without sufficient scientific evidence, except as provided for in paragraph 7 of Article 5.

3. Members shall ensure that their sanitary and sanitary measures do not arbitrarily or unjustifiably discriminate between Members where identical or similar conditions prevail, including between their own territory and that of other Members. Sanitary and sanitary measures shall not be applied in a manner which would constitute a disguised restriction on international trade ż/em>" (emphasis added)

As such, "sufficient scientific evidence" must be invoked in order to impose restrictions on beef imports into the EU. The Ombudsman notes that, in the absence Article 5, paragraph 7 of the SPS Agreement states that, in cases where relevant "scientific evidence" is not available, a Member of the SPS Agreement may provisionally adopt sanitary or sanitary measures on the basis of "available pertinent information".

[20] See paragraph 53 above.

[21] The specific statements included in the report included the following:

"Traceability systems were in place in all establishments visited for meat intended to be exported to the EU.

Documentation to establish the link between the different production steps was well established in most establishments visited. Some minor deficiencies were identified ż/em>"

[22] In sum, it would appear that while the Food and Veterinary Office found no specific instances of lack of traceability in March 2007, it could not, because the Brazilian system of audits was inadequate, give a guarantee that the entire Brazilian system of traceability was of the requisite standard.

"No co-ordination has been established with the animal health department and representatives of SISBOV from the secretary of rural development in order to audit the complete chain back to the holding of origin."

"(Border Posts) visited between the States were properly equipped and staffed. A manual of procedures, instructions and legislation was available at the posts visited.

The work carried out at the posts was properly documented, including actions taken in case of non-compliance."

"2 Accredited Certifying Bodies (ACBs) visited did not keep the database up-to-date regarding registered animals on holdings."

"None of the ACBs visited had defined control procedures in place regarding own check controls, and audit plans for 2007 were not established."

"Controls were carried out in a limited area, near the head office only."

[23] This is, the Ombudsman understands, the standard which is required in order to ensure food safety.

[24] Special conditions were imposed which required that beef could only be imported into the EU from identified authorised holdings in relation to which sufficient and auditable guarantees could be provided.

[25] SISBOV is the Brazilian Identification and Certification System of Bovine and Bubaline Origin. It is run by the Brazilian Ministry of Agriculture.

[26] The Ombudsman notes that such a closed system is already referred to in the report relating to the March 2007 mission to Brazil. That report stated that the Brazilian authorities aimed to put in place a closed system of authorised holdings by 2009. The report agreed that the concept of a closed system of holdings allows for better controls. The Ombudsman noted, in the report relating to the March 2007 mission, that problems were observed in the start-up phase and the transitional period. It also noted that not all recommendations of the 2006 missions were satisfactorily addressed, leading to doubts about the reliability of the system at the time of writing (which was early 2007).

[27] For an example of the suitability test, as used in EU law, see Case C-240/95 Criminal proceedings against Rꮹ Schmit [1996] ECR I-3179, paragraph 25.

[28] The Brazilian authorities originally suggested, on 28 January 2008, that 2681 holdings be put on the list. However, as no audit or inspection reports were submitted in relation to all these holdings, this suggested list was not accepted by the Commission.

[29] The mission also identified continuing deficiencies elsewhere in the Brazilian beef production system, and recommended measures to deal with these continuing deficiencies.

[30] The Ombudsman understands that the mission was carried out from 20 January to 2 February 2009.

[31] The issue of balancing interests will be examined in more detail in paragraph 129 below.

[32] See, for example, Report DG(SANCO)/7044/2004 ֠MR Final (Final Report of a mission carried out in the United Kingdom from 26 April to 7 May 2004 concerning a general review as regards protective measures against bovine spongiform encephalopathy). The "shortcomings" identified in Report DG(SANCO)/7044/2004 ֠MR Final were not such as to warrant special conditions or a ban. Rather, they gave rise to a requirement that corrective measures be taken.

[33] See Recital 8, which reads as follows:

"In order to avoid disruption of trade, consignments of fresh de-boned and matured bovine meat certified and dispatched before the entry into force of this Decision should be allowed for import into the Community for a specified period."

[34] See paragraph 120 above.

[35] The Ombudsman notes that as a consequence of the outbreaks of foot and mouth disease in Mato Grosso do Sul in October 2005, the Commission suspended all imports of beef from the state of Mato Grosso do Sul, and from the neighbouring states of Paranࡡnd Sao Paulo for animals slaughtered after 30 September 2005. As such, the Ombudsman understands that it is feasible, if the situation so demands, immediately to impose restrictions on the importation of beef.

[36] As regards the balancing exercise, the Ombudsman notes that foot and mouth disease is, according to the Commission itself, one of the most contagious animal diseases. An outbreak of foot and mouth disease can cause very severe economic losses (a joint report by the UK Department for Environment, Food and Rural Affairs and the Department for Culture, Media and Sport put the cost of the 2001 foot and mouth outbreak in the UK at Sterling 3 billion for the UK agricultural/food industry ("Economic Cost of Foot and Mouth Disease in the UK: a Joint Working Paper")). Furthermore, the Ombudsman notes that one of the objectives of Decision 2008/61/EC was to ensure that any meat imported from Brazil is traceable. The Ombudsman recalls that traceability allows public authorities to react rapidly and effectively to any emerging public health or sanitary threats by pinpointing, as soon as possible, after the identification of an outbreak, the origin of meat. Traceability thus allows public authorities to take immediate measures for the purpose of eliminating risks to animal or public health.