C-393/01

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(c) materials which are destined for use in 6. The ban was extended until 1 February cosmetic or medicinal products or 2000 by Commission Decision 99/517/EC medical devices.' of 28 July 1999 amending Decision 98/653. 5The Portuguese Republic brought an action for annulment of that decision, which was dismissed by the Court. 6

4. Under Article 14 of that decision, the Portuguese Republic was required to send to the Commission every four weeks a report on the application of the protective measures taken against TSEs (transmissible spongiform encephalopathies) in accord- ance with Community and national provi- 7. The ban was then extended for an sions and on the results of the programmes indefinite period by Commission Decision referred to in Article 13. 2000/104ÆC of 31 January 2000 amend- ing Decision 98/653. 7

5. Article 15 provided:

8. The conditions for lifting the ban were 'The Commission shall carry out Commu- laid down by Commission Decision nity inspections on-the-spot in Portugal to: 2001/376/EC of 18 April 2001 concerning measures made necessary by the occurrence of bovine spongiform encephalopathy in Portugal and implementing a date-based export scheme. 8 (a) verify the application of the provisions of this Decision, in particular in relation to the implementation of offi- cial controls;

'(6) A mission carried out in Portugal by (10) Portugal presented its first request for the Food and Veterinary Office from a date-based export scheme with a 14 to 18 June 1999 concluded that the view to permitting, subject to certain recall of existing stocks was completed conditions, the dispatch of products and that the controls on the effective- from animals born after a certain date ness of the feed ban were applied to the Commission on 3 December properly. 1999. These technical proposals were subsequently amended and supple- mented on 18 February, 24 March, 27 July and 22 September. The amended and supplemented proposals provide a suitable framework for allowing the dispatch and export of products derived from bovine animals (7) A ban on the use of specified risk slaughtered in Portugal. materials in human food or animal feed was introduced in Portugal on 4 December 1998. The ban has been extended in accordance with Commis- sion Decision 2000/418/EC of 29 June 2000 regulating the use of material presenting risks as regards (11) The measures for implementation of transmissible spongiform encephalo- the export scheme and the offspring pathies, 9 as amended by Decision cull 11 will be examined by the Food 2001/2/EC. 10 and Veterinary Office of the Commis- sion before the dispatch of meat and meat products may commence. If that examination is satisfactory the Com- mission will set the date on which dispatch may commence.'

(8) According to the national BSE eradi- cation plan in place in Portugal, birth cohorts and offspring of BSE cases shall be slaughtered and destroyed. 10. Article 6 of Decision 2001/376 renews the ban on the export of deboned fresh

17. Article 21 of Decision 2001/376 states:

13. Article 11(1) to (4) of Decision 2001/376 lays down specific conditions relating to slaughterhouses, cutting plants, 'The Commission shall carry out Commu- storage and transport of meat. nity inspections on-the-spot:

14. Article 12 of Decision 2001/376 pro- (a) in Portugal to verify the implemen- vides that meat and products exported tation of official controls in respect of

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each of the products referred to in 18. Article 22(2) of Decision 2001/376 Articles 7 and 8 before the dispatch of reads as follows: these products may commence or re- commence;

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and 12 and Annex IV to Decision — order the Commission to pay the costs. 2001/376/EC, have shown that the conditions are complied with satisfac- torily.

23. The defendant contends that the Court should: (3) The Commission has presented the results of the inspections and the con- sequences it draws from them to the Member States convened in the Stand- ing Veterinary Committee. The Com- mission has received from Portugal guarantees on the full application and — dismiss the application as unfounded; effective enforcement of Community legislation on surveillance for and eradication of TSEs, in addition to those guarantees requested by the report of the Food and Veterinary Office'. — order the applicant to pay the costs.

III — Forms of order sought and inter- 24. By order of the President of the Court ventions of 1 March 2002, the Portuguese Republic was granted leave to intervene in the case in support of the Commission.

21. Since the French Republic took the view that the conditions for lifting the ban on Portuguese beef and veal were not met, it brought an action for annulment of the contested decision. 25. By order of the President of the Court of 8 March 2002, the United Kingdom of Great Britain and Northern Ireland was granted leave to intervene in the case in support of the Commission. However, in 22. It claims that the Court should: light of the pleadings lodged by the parties, the United Kingdom Government informed the Court that it had nothing to add to the arguments put forward by the Commission and that it waived the right to lodge a — annul the contested decision; pleading itself.

28. Suffice it to state in relation to those 30. In the French Government's sub- submissions that the French Government mission, the words 'taking account of the has devoted itself to proving, in the present inspections referred to in Article 21', which

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appear in Article 22(2) of Decision 33. According to the French Government, 2001/376, should be interpreted as making the final inspection report of the Food and removal of the ban dependent on the Veterinary Office ('the FVO') sent to it carrying out and the outcome of the before the contested decision was the report inspections listed in Article 21. of 25 to 27 June 2001 (Mission Report 3345/2001), which relates to the general conditions for export laid down under the DBES in particular the approval of estab- lishments, eligible herds, eligible animals, controls in slaughterhouses and cutting 31. The French Government considers that plants, certification and transport. It states the Commission adopted the contested that, on the other hand, the report does not decision without having carried out all the examine the incidence of the disease and inspections provided for in Article 21. enforcement of the relevant national meas- ures, and does not include a risk assessment demonstrating whether appropriate meas- ures to manage any risk had been taken.

32. Under Article 21, those inspections were required in order to:

— verify application of the provisions in Articles 11 and 12 of Decision 2001/376 and Annex IV thereto;

38. As regards the findings made by the Commission relating to Article 21(b) of Decision 2001/376, that is to say verifi- 35. In addition, the French Government's cation of the application of the provisions representative stated at the hearing that it is in Articles 11 and 12 of that decision and desirable in the present instance that con- Annex IV thereto, the French Government trol of the DBES go hand in hand with a points out the following matters in par- more general assessment of the situation, ticular: enabling in particular it to be determined whether in good faith a suspect animal would not have been able to qualify under the DBES.

— a letter sent on 11 June 2001 by the Commission to the Portuguese auth- orities clearly shows that the DBES was not yet applied as at that date and 36. In the French Government's view, reveals numerous weaknesses in the when the mission report was submitted, mechanism to ensure traceability the rules and the circular relating to the before and after slaughter and the DBES implementation manual were not in mechanism for keeping separate the force, certain FVO inspections were still channels for eligible and ineligible awaited and therefore Article 21(c) of products, and the absence of any alarm Decision 2001/376 had not been complied plan should an animal associated with with as regards 'the implementation of risk be identified; official controls'.

— the report of the FVO mission from 25 37. The French Government adds that the to 27 June 2001 simply recalls the period between adoption of the Portuguese conditions of the DBES which had to legislation and the lifting of the ban simply be formalised in the draft decree and did not leave businesses time to familiarise the DBES manual, without containing themselves with DBES practices and pro- anything to show that the points of cedures. The effectiveness of the procedure non-compliance noted in the letter of

11 June 2001 resulted in specific cor- 42. It states in particular that the report of rective measures (in particular the rules the mission from 14 to 18 May 2001 on backwards and forwards traceabil- expressed criticism with regard to animal ity). meal and specified risk material and for- mulated recommendations. The report sets out undertakings in this regard on the part of the Portuguese authorities, but it is not apparent from any other document that measures were in fact taken to remedy the defects which had been pointed out. 39. The French Government also points out that the Commission did not send copies of the legislation adopted by the Portuguese authorities enabling the dates of publication and circulation to be checked. Nor was it possible, given that the Com- mission did not send any subsequent inspection report or any monthly report, 43. As for Article 21(d) of Decision to assess the knowledge of the rules pos- 2001/376, that is to say tests and epidemi- sessed by the Portuguese authorities ological monitoring, the French Govern- entrusted with the controls. ment states that the report of the mission from 14 to 18 May 2001 contained numer- ous criticisms in that regard. Nevertheless, the Commission did not check the action taken in response to the recommendations formulated by the experts, thus infringing Article 21(d). 40. The French Government maintains that the contested decision is also invalid inas- much as the Commission did not take into account whether or not traceability meas- ures existed in the other Member States before setting the date for the removal of the ban. 44. Furthermore, because of the small number of tests carried out and the lack of distance from the relevant procedures set up (strategy of eliminating the cohorts of animals affected by BSE and their direct issue, procedure for the removal/destruc- 41. When it examines the findings made by tion of animals over 30 months old), the the Commission relating to Article 21(c) of effectiveness of the cattle-testing pro- Decision 2001/376 and, in particular, the gramme in Portugal could not have been implementation of official controls, the verified before the contested decision was French Government points out the import- adopted and brought into force. The Com- ance of those controls given that the risks mission could not therefore have conducted can be eliminated only if the DBES is a risk assessment complying with strictly observed. Article 21(d) of Decision 2001/376, since

49. The Commission contends that the matters referred to in Article 21 of Decision 2001/376 had to be taken into account by it to varying degrees. It had to take account 47. The Commission observes that the of all the inspections carried out since various decisions are founded on Council Decision 98/653 and to check rigorously Directive 89/662/EEC of 11 December that the inspections referred to in 1989 concerning veterinary checks in intra- Article 21(b) had been carried out and Community trade with a view to the supported the conclusion that the Por- completion of the internal market 12 and tuguese Republic provided all the necessary Council Directive 90/425/EEC of 26 June safeguards. It considers that it had met 1990 concerning veterinary and zootech- those two requirements, which do not bind nical checks applicable in intra-Community it with the same force, when it decided to trade in certain live animals and products set a date for the recommencement of with a view to the completion of the dispatch under the DBES.

12 — OJ 1989 L 393, p. 13. 13 — OJ 1990 I. 224, p. 29.

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51. The Commission contends that the literal interpretation advanced by the French Government could well result in breach of the principle of proportionality because the three channels are separate. For example, it is not possible to justify a refusal in respect of the dispatch of risk material for the purpose of incineration in 54. Article 21(c) and (d) are couched in another Member State on the ground that very general terms and contain no specific there are shortcomings in the DBES chan- reference to the DBES; they are to be seen nel. It can easily be seen that the inspections in correlation with Article 4 of Directive referred to in Article 21(d) extend far 89/662 and Article 10(4) of Directive beyond the context of the recommencement 90/425, which require the Commission to of exports and must be carried out regard- monitor the situation in the context of the less of their recommencement. protective clause and to adapt the measures taken if appropriate. The wording of Article 21(c) and (d) repeats that of Article 15 of Decision 98/653 which intro- duced the ban, and there is continuity between Article 15 of Decision 98/653 and Article 21(c) and (d) of Decision 52. The Commission contests, finally, the 2001/376. The Commission infers there- French Government's use of the recitals in from that an inspection visit or an assess- the preamble to Decision 2001/376 to ment under Article 15 of Decision 98/653 is support the literal interpretation of equivalent to an inspection visit under Article 22(2). Those recitals come within Decision 2001/376, unless, of course, the the framework of Articles 11 and 12 and conclusions in question are overtaken by Annex IV, which are the provisions directly events.

(i) Observations of the Commission regard- ing the inspections required pursuant to 59. The letter of 11 June 2001 merely Article 21(b) of Decision 2001/376 pointed out certain residual problems. The mission in June confirms that, on the basis of that letter, the Portuguese authorities found solutions to each of the points raised. In particular, the Portuguese Government responded to the problems of traceability raised by the Commission and that 57. The Commission submits with regard response was assessed by the FVO well to Article 21(b) of Decision 2001/376 that before the date for the recommencement of it is apparent from point 6.1 of the con- exports was set. clusions in the report of the mission carried out from 25 to 27 June 2001 that imple- mentation of the DBES in Portugal was in accordance with the requirements of Decision 2001/376. The FVO mentioned only the absence of legal provisions and of 60. The Commission states that the report written instructions. The Decree-Law of of the FVO mission which took place from 31 July 2001 (the date of its publication) 25 to 27 June 2001 contains conclusions was approved by the Portuguese Council of favourable, as a whole, to the lifting of the Ministers on 12 July 2001, promulgated by ban, in particular so far as concerns the the President of the Republic on 29 July effectiveness of implementation of the pro- 2001 and countersigned by the Prime cedures.

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61. The only recommendations addressed be approved before inspection by the to the Commission contained in that report FVO of the proposed arrangements.' were as follows:

such a visit, the Minister of Agriculture will and of the Council of 17 July 2000 decide on the approval.' establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820/97 14 and its implementing regulation, which have been applicable since 1 August 2000, that is to say before the Portuguese DBES was set up, ensure that there is a system for tracing beef 63. The Commission accepts that the FVO throughout the Community. did not observe how the DBES actually operated, but it points out that such verifi- cation was, in practice, impossible at a time when authorisation to recommence exports had not yet been granted and the system could not be at the stage of functioning correctly. 66. The Commission concludes therefrom that it has scrupulously observed the con- dition relating to the inspection required under Article 21(b) of Decision 2001/376.

64. As regards the monthly reports referred 67. It contests the French Government's to in Article 20 of Decision 2001/376, the argument that Portuguese officials did not Commission points out that it is not have time to familiarise themselves with obliged by that provision to forward them DBES procedures. It acknowledges that, in to the other Member States. the formal sense, the period was short, but points out that the DBES had been dis- cussed intensively with the Portuguese authorities, that Community inspections had enabled the approach to be refined and that the DBES was already known because of the United Kingdom precedent.

ceability, the Commission refers to the to in Article 21(c) and (d) were in fact report of the mission carried out by the carried out throughout the period of the FVO from 25 to 27 June 2001. It also ban and that they were certainly taken into observes that establishment of the DBES account when deciding the date for lifting was never conditional on the establishment the ban. of rapid tests. The latter constitute one of the instruments available under the system for monitoring TSEs. It adds that while the number of rapid tests in Portugal was on the low side, account had to be taken of the policy of systematic slaughter pursued by the authorities and of the fact that the 70. The Commission further submits that authorities had given guarantees concern- the French Government is wrong in its ing the carrying out of those tests. Finally, assertion that all those inspections and since DBES-eligible animals must be born assessments should necessarily have been after 1 July 1999, the date upon which the ban on animal meal in fact entered into carried out after Decision 2001/376 entered force, and given the very long incubation into force. period of the disease, it is highly improb- able that tests carried out on eligible animals, even infected animals, could have given positive results at the time when the ban was lifted.

71. The Commission refers to various points of the report of the FVO mission in June 2001 with regard to controls relating to product traceability. It explains that scrutiny of the DBES was not the only (ii) Observations of the Commission objective of the mission in May 2001, a fact regarding the inspections and assessments which explains why the report mentions required pursuant to Article 21(c) and (d) shortcomings in the implementation of of Decision 2001/376 (identical to those other Community decisions that are inde- required by Article 15 of Decision 98/653) pendent of implementation of the DBES. As regards the removal of specified risk material, the May report mentions only minor problems and concludes that its removal was, as a whole, satisfactory.

(c) Arguments of the Portuguese Govern- broached at the FVO meeting. The mission ment from 25 to 27 June 2001 was thus carried out solely in order to evaluate the appli- cation of the DBES. The recommendations set out at the FVO meeting were taken into account. The DBES was assessed in full operation in the only slaughterhouse 73. The Portuguese Government points out selected and approved by the Portuguese that implementation of a date-based export authorities for its implementation. scheme has been studied since 1999. Exam- inations as to the eligibility of cattle under the DBES were carried out (BSE mission of March 2000). Subsequently, the principles for the selection of holdings and animals were harmonised. The Community mission in May 2001 was essentially intended to evaluate all the procedures governing the 76. The mission report concluded that the eligibility of holdings and animals under DBES procedures manual fulfilled the the DBES. Those procedures were con- requirements of Decision 2001/376 which sidered satisfactory and, in certain cases, is applicable here. It also concluded that the were improved. programme for the tracing and destruction of the offspring of BSE cases was effective. In order for the Commission to set the date for the lifting of the ban, however, the Portuguese authorities had to confirm in writing both that the final version of the 74. In this connection, the Portuguese procedures manual (which, at this stage, Government observes that the French Gov- took account of all the recommendations ernment's comments relating to the trace- made) had been issued and that the appli- ability problems pointed out in that report cable legislation had been published. The make no sense since those problems relate report in question also recommended that to animals born before 1998, whereas only no premises at which animals were slaught- cattle born after July 1999 are eligible ered and destroyed falling within the DBES under the DBES. should be approved by the Portuguese authorities without the FVO having checked the conditions under which exports could be permitted.

tuguese authorities, without the slightest regard to either compliance with the con- reaction on the part of the Member States. ditions of the DBES stricto sensu or proper The committee was not given the specific application of the various measures to date on which the decision was to take combat BSE that are separate from the effect since the Commission had not yet DBES but expressly covered or recalled by come to the end of the internal procedure Decision 2001/376. for adoption of the decision. However, after the committee's consent had been obtained, 1 August 2001 was the date initially given. The Portuguese Government states that all the required guarantees had been provided, both by its national official at the Permanent Representation and by the 80. The French Government submits that Portuguese Directorate-General for Vet- the Portuguese control mechanism was erinary Affairs, and that the data and the neither legally effective nor being imple- content of the documents required were mented in practice by the Portuguese auth- known to all the parties. The process which orities on the date when the Commission led to adoption of the contested decision adopted its decision. Accordingly, the Por- took place in close collaboration with the tuguese Government is all the more unable competent bodies, the Commission and the to assert that that mechanism was in force sole establishment authorised to apply the when the Standing Veterinary Committee DBES. met, that is to say on 11 July 2001.

78. The Portuguese Government states that it therefore does not understand the pos- ition adopted by the French Government. 81. It is therefore not possible to maintain In particular, the proposition that a copy of that at that meeting the FVO inspectors the legislation as published had to be presented in detail the measures adopted by produced is unfounded. the Portuguese authorities, when draft measures were in fact involved.

83. As the Portuguese decree-law was pub- of all the measures to combat BSE, in lished after the date of the Commission particular concerning the traceability of decision, it would have been appropriate animals and meat and measures governing for the Commission to satisfy itself rapidly, hygiene, slaughter and cutting. through a fresh FVO inspection, that the dispatch that had thus recommenced was in fact in conformity with the conditions laid down by the D BES. 86. As regards the period from September 2000 to July 2001 in particular, the French Government observes that the Portuguese Government acknowledges, as is apparent from its statement in intervention (para- graphs 18 and 19), that the actions render- ing the procedures compliant concerned 84. However, the first FVO inspection only the DBES, and that they occurred mission to Portugal subsequent to 25 July progressively and after the meeting of the 2001 did not take place until 28 January to Standing Veterinary Committee and the 8 February 2002. It related to 'the tracea- contested decision. bility of fresh meat and of bovine products from the farm to placing on the market' and Decision 2001/376 is not included in the list of legislation whose application was to be checked by that mission. 87. The French Government also analyses the 43 rd report drawn up by the Portuguese authorities in accordance with Decision 98/653. This report reveals the following in particular:

(a) The role of the inspections to which Articles 21 and 22 of Decision 2001/376 refer 88. The French Government concludes that those monthly reports show that all the rules to combat BSE should have been complied with by the Portuguese auth- orities before the contested decision was 90. According to Article 22(2), 'the dates adopted. on which the dispatch of material and products may commence or recommence pursuant to Articles 5, 7 and 11 shall be determined by the Commission taking account of the inspections referred to in Article 21 and after having informed the Member States'. 2. Appraisal

91. There can be no doubt, in my view, that the Commission cannot determine the 89. I will examine in turn: dates in question until all the conditions laid down by Decision 2001/376 for lifting the ban on a given category of products are met.

•— the role to be played in the Commis- sion decision to lift the ban by the 92. In addition to the written guarantees inspections prescribed in Article 21 of which appear to have been provided to the Decision 2001/376; Commission by the Portuguese Republic

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(see the third recital in the preamble to the (d) ... to examine the development of the contested decision), the Commission must incidence of the disease, the effective therefore take its decision 'taking account enforcement of the relevant national of the inspections'. measures...;

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99. It should, however, be noted at this they do not relate to a specific category of point that the contested decision concerns products. only the products referred to in Article 11 of Decision 2001/376, that is to say fresh meat, minced meat and meat preparations, meat products, and food which is destined for domestic carnivores. We need not (b) Was the inspection prescribed in therefore examine whether inspections Article 21(b) of Decision 2001/376 carried under Article 21(a), which concern amino out properly? acids, peptides, tallow, products containing tallow and products derived from tallow, or those referred to in Article 21(e), which concern meat meal, bone meal, meat-and- bone meal and so forth dispatched to another Member State for the purpose of 103. The question which arises is whether incineration, were performed correctly and the Commission in fact 'verified the appli- whether their results were convincing. cation' of the provisions in Articles 11 and 12 of Decision 2001/376 and in Annex IV thereto before permitting the dispatch of beef and veal to recommence.

100. My examination will relate solely to the results of the inspection of type (b) which was carried out and which concerns 104. This can be taken to be extremely fresh meat, minced meat, meat prepara- unlikely given that the domestic rules tions and meat products. intended to oblige or help all the bodies and all the persons concerned to comply with the provisions of the DBES were finalised, with the aid of the FVO experts, only in the course of the inspection mission which took place from 25 to 27 June 2001, that is to say one month before the Com- 101. There is thus no risk of creating, mission decision to lift the ban. between the three channels, the confusion of which the Commission has warned.

106. However, the decree-law incorporat- 109. If I have understood the Commission ing those rules was not published until correctly, this therefore means that it denies 31 July 2001, that is to say after the the very possibility of 'verifying the appli- contested decision and on the eve of the cation' of the provisions constituting the lifting of the ban. The 'manual' does seem DBES before exports recommenced. to have been approved by the Portuguese Secretary of State and the authorities in the Ministry of Agriculture on 13 July 2001, but we have no information regarding when it was actually distributed. Even 110. However, that interpretation is contrary to the wording of Article 21(b) 16 — Emphasis added. of Decision 2001/376.

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111. Moreover, it would, in my view, have ment points out, businesses simply did not been possible to have the system operating have the time to familiarise themselves with without any exports, that is to say by the final version of the DBES procedures. selling the meat on the Portuguese market for the time being.

115. I am unable to agree with the Por- tuguese Government when it states that 'the DBES was assessed in full operation in 112. I consider, therefore, that the afore- the slaughterhouse approved'. mentioned statement by the Commission would in itself be sufficient to find that the Commission infringed Articles 21 and 22 of Decision 2001/376 and consequently to justify annulment of the contested decision.

116. The mission in June 2001 admittedly included a visit to the slaughterhouse and cutting plant which were candidates for approval under the DBES.

121. It follows that that final inspection before the ban was lifted could not truly have achieved its objective which, accord- ing to point 2 of the report, was 'to evaluate the implementation of the DBES, in particular the implementation of official controls related to the scheme in the framework of Article 11 of the Commission Decision 2001/376/EC'. 17 After approval, the holding will be subject to further on-farm inspections once every four months.'

122. The inevitable conclusion is, there- fore, that the inspection carried out pur- suant to Article 21(b) of Decision 2001/376

Point 5.1.4.3. '... animals on the list will be 17 — This footnote is not relevant to the English translation of subject to a set of pre-slaughter checks'. the Opinion.

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did not provide sufficient justification for is not directly concerned with establishing lifting the ban. the DBES, their results do not bind it with the same force when it decides to set the date for the recommencement of exports. The Commission adds that those checks were in fact carried out throughout the period of the ban and that they were taken into account when deciding to lift it. 123. It remains for me to examine now the French Government's argument that the inspections prescribed in Article 21(c) and (d) of Decision 2001/376 were not duly carried out.

(a) amino acids, peptides and tallow pro- duced in establishments under official veterinary supervision which have been 132. The fact that the controls of a more shown to be operating in accordance general type which were already included with the conditions set out in the in Decision 98/653 were retained in annex; Decision 2001/376, while at the same time more specific inspections 'before the rec- ommencement of dispatch' were intro- duced, suggests that all those inspections must take place alongside one another. (b) tallow products and products derived from tallow by saponification, trans- esterification or hydrolysis.

133. It follows that deficiencies recorded when carrying out the more general checks 129. Decision 2001/376 instructs the Com- under Article 21(c) and (d) of Decision mission, in Article 21(a), to 'verify the 2001/376 must be taken into consideration implementation of official controls in by the Commission at the same time as the respect of each of the products referred to findings made in carrying out the specific in Articles 7 and 8 before the dispatch of inspections under Article 21(a) and (b). these products may commence or recom- mence'.

130. Articles 7 and 8 refer to more or less 134. It is true that the rules which apply in the same products as those just mentioned. the context of the inspections of type (b), that is to say principally those set out in Annex IV to Decision 2001/376, are so exacting as regards slaughter of the off- spring of diseased animals, the monitoring of herds and the identification and tracea- 131. Dispatch of those products thus seems bility of animals intended for export that not to have commenced following Decision all the shortcomings in the systems should 98/653. Articles 7, 8 and 21(a) of Decision normally be discovered in the course of 2001/376 and Annex II thereto made their those inspections.

136. Thus, point 13 of Annex IV requires traceability both forwards and backwards. 138. On the other hand, on an inspection What does backwards traceability mean if which took place from 28 January to not maximum certainty, or at least an 8 February 2002 and was devoted not to entirely reasonable degree of certainty, on analysing the operation of the DBES but to the basis of scientific guarantees resulting evaluating implementation of all the Com- from a reliable livestock-control system, munity regulations and directives relating that there is no suspicion as regards an to the identification and registration of animal's being diseased? General controls cattle and to intra-Community trade in admittedly do not interest us here in so far animals and meat, the inspectors stated as as they concern products outside the DBES follows in their summary of the final or abattoirs and cutting plants outside the report: DBES, but they interest us in so far as they concern the state of the livestock popu- lation from which an animal entering the DBES-approved slaughterhouse comes. At that point the national databases will be checked. Previous inspections (in particular those of May 2001) revealed that the level of reliability of those databases was, to say 'Depending on which part of the produc- the least, poor and the June inspections tion chain was involved, the controls provided no positive evidence to the established by the competent authority contrary. gave a contrasting picture: the measures in place for registering holdings, identifying animals and controlling their movement were not satisfactory, either qualitatively or quantitatively, mainly because all the risk factors were not properly taken into account and also because, in several cases, 137. It is also to be noted that, in contrast there was insufficient manpower to carry to the position when the date for lifting the out adequate controls. As far as slaughter- ban on United Kingdom meat was set (see houses were concerned, the situation was the second recital in the preamble to generally satisfactory, except for one Commission Decision 1999/514/EC of 23 July 1999 setting the date on which dispatch from the United Kingdom of 18 — OJ 1999 L 195, p. 42.

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144. In the alternative, the Commission determine the level of health protection denies that there has been any infringement that it considered appropriate. of the precautionary principle.

145. It observes that the precautionary 148. In its submission, Decisions 98/653 principle is not an absolute objective that and 2001/376 were founded on precaution- would exclude any possibility of appraisal ary logic. Decision 98/653 imposing the on the part of the competent authority ban was never conceived of as a definitive which must implement the policy. Both measure. Once the appropriate measures Article 174 EC, which is cited by the had been taken by the Portuguese Republic applicant and relates to the environment, and duly evaluated and checked by the and Article 152 EC, which relates to public Commission, that transitional measure was health, in fact seek a high level of pro- to be repealed. tection. The Commission refers to Com- munication COM(2000) 0001 final which it has adopted on the precautionary prin- ciple, in which it has endeavoured to establish a number of criteria, and to the Court's case-law. 149. The Commission contends, finally, that the precautionary principle is a rea- soned approach founded not on the pursuit of absolutely no risk, which would paralyse trade completely, but on the constant 146. According to the Commission, the pursuit of proportionality. In this context, precautionary principle does not have the it recalls that it has a discretion under effect of obliging it to follow every scien- Article 9(4) of Directive 89/662 and tific opinion without any power of apprai- Article 10(4) of Directive 90/425 and that sal. The same is true of the opinion of a judicial review is limited to ascertaining national agency such as the Agence fran- whether it has manifestly erred in the çaise de sécurité sanitaire des aliments exercise of that discretion. (French Food Safety Agency), which, the Commission observes, is subsequent to the contested decision.

tributing to those objectives. A measure 153. The French Government recalls the seeking to protect health must be taken into uncertainty as to the risks and the fact that account, but it must not exceed what is the DBES is founded on scientific assump- necessary in order to attain that objective tions. without endangering the other objectives of the common agricultural policy. After the Portuguese Republic had provided the requisite guarantees, it was normal, given the high level of protection ensured, to replace the regime imposing a ban with a 154. It submits that the contested decision regime, laying down a framework and infringes the precautionary principle providing for monitoring, that was less because it was adopted without any guar- restrictive as regards the principle of the antee as to the results of the checks regard- free movement of goods. ing application of the Portuguese DBES mechanism and the related traceability rules, and in the absence of results for controls in respect of the other measures to combat BSE (meal, specified risk material, tests and so forth) that were supposed to be put in place in Portugal. 151. The Commission observes that, while the precautionary principle entails an approach to assessment in terms of benefits and burdens, it is impossible to arrive at a level of risk equal to zero. It stresses, in this connection, that the decisions adopted 155. In its statement in intervention, the followed the opinions of the various scien- Portuguese Government submits that the tific committees and that it attentively precautionary principle has been fully monitors developments in scientific observed. It acknowledges that the prin- research. ciple applies in fields such as human, animal or plant health and points out that the conditions for its application include perception or identification of a potential risk and the carrying out of a scientific study whose results are uncertain or doubt- ful. 152. In its reply, the French Government contests the proposition set out by the Commission as its main claim and contends that the plea relating to the precautionary principle is an independent plea. By its 156. It points out that it was in response to adoption of the contested decision without new scientific data that the possibility was checking compliance with the conditions envisaged of authorising exports under laid down by Decision 2001/376, the certain conditions enabling a high level of Commission is not ensuring the level of health protection to continue to be main- public health protection that it is supposed tained. It recalls the collaboration of the to and is infringing the precautionary Portuguese authorities with the experts and principle. the efforts made since 2000.

159. The French Government contests, in the present instance, the effectiveness of the control measures prescribed and disputes therefore that they comply with the pre- cautionary principle from the point of view of risk management. It refers in this regard 162. Accordingly, as the French Govern- to the final FVO report received, relating to ment has not demonstrated the existence of a mission carried out in Portugal between an infringement of the precautionary prin- 28 January and 2 February 2002. It is ciple independent of an infringement of apparent from this report that identifica- Decision 2001/376, this second plea must tion of animals and the following of their be regarded as immaterial. movements and traceability of meat were not guaranteed, whereas the entire DBES mechanism rests on those matters. 19 — See above, point 151.

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FRANCE v COMMISSION

V — Conclusion

163. For all the reasons set out above, I propose that the Court should:

— annul Commission Decision 2001/577/EC of 25 July 2001 setting the date on which dispatch from Portugal of bovine products under the Date-Based Export Scheme may commence by virtue of Article 22(2) of Decision 2001/376/EC;