C-301/98

KVS INTERNATIONAL

OPINION OF ADVOCATE GENERAL SAGGIO delivered o n 2 7 J a n u a r y 2 0 0 0 *

1. By order of 17 July 1998, the College 3. The fourth recital in its preamble reads van Beroep voor het Bedrijfsleven of the '(...) in the context of intra-Communily Netherlands referred to the Court for a trade in semen, the Member State where preliminary ruling four questions relating the semen is collected should be under an to Council Directive 8 8 / 4 0 7 / E E C of obligation to ensure that such semen has 14 June 1988 'laying down the animal been collected and processed at approved health requirements applicable to intra- and supervised semen collection centres, Community trade in and imports of deep- has been obtained from animals whose frozen semen of domestic animals of the health status is such as to ensure that the bovine species' 1 and Directive 93/60/EEC risk of spread of animal disease is elimi- of 30 June 1993 'amending Directive nated, has been collected, processed, stored 88/407/EEC'. 2 Those questions were sub- and transported in accordance with rules mitted by the Netherlands court in the which preserve its health status and is context of appeal proceedings brought by accompanied during transport to the coun- K.V.S. International BV (hereinafter 'KVS') try of destination by an animal health against the refusal by the Minister van certificate in order to ensure that this Landbouw, Natuurbeheer en Visserij (here- obligation has been fulfilled'. inafter the 'Netherlands Ministry of Agri- culture') to issue a certificate for the export to other Member States of deep-frozen semen from the bull If de Focant. 4. Article 3 provides that 'Each Member State shall ensure that only semen meeting the following general conditions is sent from its territory to the territory of another Member State:

(i) which are officially tuberculosis free; 8. In 1993, Directive 88/407 was amended by Directive 93/60/EEC. 3 In the fourth recital in its preamble it is stated that '(...) it is opportune to make further amendments to the (...) Directive [88/407/EEC] to clarify certain issues and to take account of (ii) which are officially brucellosis free technical progress, particularly in respect or brucellosis free. The animals of treatment of bulls against leptospirosis, may not previously have been kept and to align the rules with respect to in other herds of a lower status'. brucellosis, tuberculosis and leucosis on those laid down in Directive 64/432/EEC'. 4

3 — Cited above. 4 — Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine 6. Finally, Article 6.1 provides that 'Mem- animals and swine (OJ, English Special Edition 1963-1964, p. 164), last amended by Directive 92/102/EEC (OJ 1992 ber States shall make the admission of L 355, p. 32).

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5 — I feel it should he stated that Annex A to Directive 64/432/ EEC cited above defines, among other things, what is meant by a bovine holding 'officially free from brucellosis' and 'free front brucellosis'. According to paragraph 2 of that Annex, a bovine holding is to be regarded as 'officially free Relevant national provisions front brucellosis' if: '(a) it contains no bovine animals which have been vaccinated against brucellosis by use of a live vaccine; (b) all the bovine animals have been free from clinical signs of brucellosis for at least six months; (c) all the bovine animals over twelve months old: (aa) have shown a brucella count lower than 30 international units of agglu- tination per millilitre when given at six-monthly intervals two official sero-agglutination tests complying with Annex 11. The national legislation which is rele- C; the first sero-agglutination test may be replaced by three ring-tests carried out at three-monthly intervals provided, vant as far as the case under discussion however, that the second sero-agglutination test is carried today is concerned is essentially to be found out at least six weeks after the third ring-test; (bb) are checked annually, to establish that brucellosis is not present in three sources: the Netherlands Law on by means of three ring-tests carried out at intervals of at least three months or two ring-tests and one sero-agglutina-

test not more than thirty days before it was taken into the ten). From that legislation it may be seen herd and, in addition, that it is from an officially brucellosis- free bovine herd.' In accordance with paragraph 3 of that that bovine semen can be exported to Annex, a bovine holding is, on the other hand, to be regarded as 'free from brucellosis' in the following cases: 'A another Member State of the Community bovine herd is considered to be brucellosis-free if: (a) by way of derogation front paragraph 2 (a), it contains bovine only if it is accompanied by a certificate animals between five and eight months old which have been issued following an examination carried vaccinated only with live vaccine Buck 19; (b) all the bovine animals fulfil the conditions laid down m paragraph 2 (b), out on the initiative of the national autho- (c) and (d); bovine animals less than thirty months old may, however, show a brucella count equal to or higher than 30

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Facts and questions referred for a prelimin- Inspectorate sent a letter to the Netherlands ary ruling Meat and Livestock Inspectorate ( R W — Rijksdienst voor de Keuring van Vee en Vlees) in which it challenged that admis- sion, maintaining that the herd in which the bull in q u e s t i o n w a s b o r n a n d h a d 12. KVS, which is the plaintiff in the main remained had been a centre of brucellosis proceedings, manages an AI centre in the for a time. According to the Belgian Netherlands which was officially approved Inspectorate, If de Focant did not accord- by the European Union as a semen collec- ingly meet the conditions in Directive tion centre from 16 May 1992. Previously, 88/407 for admission to a semen collection it had only had national approval. centre officially approved by the European Union; this was because, in the Inspector- ate's view, paragraph 1(b) of Chapter I of Annex B to that Directive was construed as ruling out any health risk, particularly the potential risk posed by a breeding bull 13. In 1991, KVS imported the breeding which, for part of its life, had belonged to bull If de Focant from Belgium to bring it 'a non-qualified herd', in other words fail- into its centre. This bull came from the herd ing to meet the requirements of Community belonging to M r Eugène Detal, in which it provisions. had been born in 1988 and had remained continuously until it was transferred to the collection centre.

16. The Belgian veterinary authorities' 18. If de F o c a n twas slaughtered in Novem- response to this was to turn to the Eur- ber 1993 following a hip displacement. On opean Commission. In a letter dated 7 June 1996, KVS asked the Netherlands 23 November 1992, however, the Commis- [Meat and] Livestock Inspectorate for a sion in fact espoused the interpretation of certificate to export to Belgium and France Community law proposed by the Nether- deep-frozen semen from that bull which lands Government, maintaining that, in its had been collected before I July 1994, the view also, the conditions of Annex B to date of implementation of Directive 93/60. Directive 88/407 had been met. The Com- mission added that, in 1992, during the proceedings for the official approval of the collection centre, If de F o c a n thad been subjected to various checks for brucellosis, all of which proved negative. Accordingly, 19. By decision of 10 June 1996, the the conclusion had to be that the bull in abovementioncd Inspectorate refused KVS question posed no risk of transmitting this the requested certificate. According to the disease and that its admission to the centre grounds for this decision, If de F o c a n tdid was, accordingly, entirely lawful. not meet the conditions imposed by the version of Annex B to Directive 88/407, then in force, inasmuch as it had been born in, and been part of, a herd of a status lower than that of 'officially free from brucellosis'.

On 28 June 1993, two days before the adoption of Directive 93/60, the European Commission changed its mind. In a letter to the Belgian Permanent Representation in 20. KVS appealed against that decision to Brussels, it stated that the semen of a bull the Netherlands Ministry of Agriculture born in a centre of brucellosis could not be but the appeal was dismissed. KVS con- the subject of intra-Coinmunity trade. tested the measure dismissing the appeal before the College van Beroep voor het Bedrijfsleven.

'(1) Must Article 3(b) of Directive 88/407/ EEC be construed as meaning that semen from a bull which was admitted to an approved semen collection centre before the adoption of amending Direc- (3) Is Directive 93/60/EEC invalid as being tive 93/60/EEC on the ground that it contrary to general principles of law, in satisfied the admission requirements in particular the principle of the protec- force at that time does not (any longer) tion of legitimate expectations and the satisfy the condition set out in Arti- principle of proportionality, in so far as cle 3(b) of the directive if the animal in that directive does not provide for question fails, at the time when certi- transitional measures to counter obsta- fication of the semen is applied for, to cles to intra-Community trade in the satisfy the amended requirement gov- semen of bulls which had already, in erning admission to a semen collection accordance with the provisions then in centre as laid down in paragraph 1(b) force, been admitted to an approved of Chapter I of Annex B to Directive semen collection centre before Direc- 88/407/EEC? tive 93/60 was adopted? I - 3590

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24. By means of that question, the national court is asking this Court whether Directive 93/60 has, by replacing the sentence '|T]hc 23. By means of the first question, the animals may not previously have been kept national court is asking the Court of Justice in other herds of a lower status' by another, whether the provisions which have to be namely '[T]he animals may not previously applied in order to establish whether the have been kept in one or more herds of a semen of If de Focant can be the subject of lower status', made a substantive amend- intra-Community trade are those in force at ment to the criteria laid down for the

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29. I consider that this point of view is the 27. KVS and the Netherlands Government one to be supported. It is well known that maintains that this equivalence does not when the literal wording of a provision I - 3592

KVS INTERNATIONAL

lends itself to various interpretations, the As the Commission and the Council point choice between them should be made out in their observations, this disease is taking account of the context of that particularly serious and contagious and it provision and 'the objects of the rules of can entail grave risks to human health which it is part'. 6 The case-law is in fact inasmuch as it is transmissible to man, orientated towards favouring the interpre- either by direct contact or via the con- tation most consistent with the aims pur- sumption of milk or products derived from sued by the provision in question. 7 milk.

34. Having regard to the objectives which 6 — Case 292/82 Merck [1983] ECR 3 7 8 1 , paragraph 12. See also Case 187/87 Saarland amd Others [1988] ECR 5013, the directive pursues, the interpretation of paragraph 19 and Case C-355/95 P TWD v Commission the expression 'other herds' cannot mani- [1997] ECR I-2549, paragraph 21. 7 — In particular, see again the Merck ease cited, paragraph 12. festly be related only to herds other than See also Case 9/70 Grad [1970] ECR 825, paragraphs 12 the one to which the animal in question and 13; Case 23/70 Haselhorst [1970] ECR 881, para- graphs 13 and 14, Case 20/70 Transports Lesage [1970] belongs, bearing in mind that the risk of ECR 8 6 1 , paragraphs 13 and 14 and Case 67/79 Fellinger [1980] ECR 535, paragraphs 6 and 7. spreading the disease which is taken into 8 — See, on this point, point 4 or this Opinion. account by the directive stems from the fact

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37. In the result, therefore, I consider that the answer to the national court's fourth question must be that the amendment made 35. I therefore consider that the expression in 1993 to the text of paragraph 1(b) of 'other herds' contained in paragraph 1(b) Chapter I of Annex B to Directive 88/704 of Chapter I of Annex B to Directive constitutes merely a statement in more 88/407 must be interpreted as meaning precise terms of the original text of the that it refers to any herds to which the bull Directive. belonged prior to its admission to the semen collection centre. Accordingly, Arti- cle 1(8) of Directive 93/60, by affirming a concept which is already to be found in preceding legislation, has not in reality entailed any substantive change in the rules governing the criteria for the admission of bovine animals to semen collection centres. 38. Should the Court agree with my pro- posed reply, it would be unnecessary for it to rule on the other questions formulated by the national court. If the original version of Directive 88/407 is held to have provi- ded that a bovine animal should not have ever remained in any herd having a health 36. It is worth adding that further confir- status lower than that of Officially free mation of the conclusions I have just from brucellosis' to be admitted to a semen reached is afforded by the fourth recital in collection centre then it must be concluded the preamble to Directive 93/60. In that that If de Focant was not lawfully admitted recital it is stated that the reasons which to the Netherlands collection centre and made it necessary to amend the original text of the Directive include that of provid- 9 — See Commission document COM(92) 462 final of ing clarifications regarding certain aspects 12 November 1992.

4 1 . According to the Council and the 39. If, on the other hand, the Court were to Commission, this question should be reach the conclusion that Directive 93/60 answered in the light of the principle of changed the rules previously in force by the non-retroactive nature of Community introducing more restrictive conditions for acts. In this connection, both institutions admission, the other questions for a pre- refer to the Salumi judgement, 11 according liminary ruling would become relevant to to which 'although procedural rules (...) the settlement of the dispute in the main apply to all proceedings pending at the time proceedings. I accordingly consider it when they enter into force, this is not the appropriate to answer also the other three case with substantive rules'. This is because questions put by the national court. '(...) the latter are usually interpreted as applying to situations existing before their entry into force only in so far as it clearly follows from their terms, objectives or general scheme that such an effect must be given to them' and because '(...) the 40. The first of these, as I have already had principle of legal certainty precludes a occasion to anticipate, 10 asks whether Community measure from taking effect semen belonging to a bull lawfully admit- from a point in time before its publication.' ted to a collection centre (inasmuch as it According to the Court of Justice 'it may be satisfies the conditions of Community law otherwise only exceptionally, where the in force at the time of admission) can be purpose to be achieved so demands and regarded as non-marketable in a Commu- where the legitimate expectations of those nity context on account of the fact that it concerned are duly respected.' 12 Referring no longer satisfies the abovemcntioned to this case-law, both institutions submit conditions at the time of the application that neither the text nor the objectives of for an export certificate since those condi- Directive 93/60 reveal an intention on the tions have changed in the meantime. In part of the legislature to attribute retro- other words, the Court is asked whether, spective effect to the amendments made to where there has been a substantive amend- the provisions relating to the conditions ment of the rules relating to the admission governing the admission of bulls to semen of bulls to collection centres in the period collection centres. Accordingly, the Direc- between the semen production stage and tive is not applicable to semen collected the marketing stage, the issue of export

prior to its implementation. They therefore question of ascertaining whether, and conclude that the legislation to which within what limits, the rule which has reference should be made in the present supervened is to apply. According to the case for the purpose of issuing the export case-law of this Court which has been certificate is that in force at the time If de cited, such a situation has to be distin- Focant entered the semen collection centre, guished from true and proper retroactivity. namely Directive 88/407 in its original Whereas that retroactivity means that pro- version. vision may have an impact on situations which have already arisen before it first came into existence, the application of a provision to developing situations relates to a different hypothesis — one in which a situation, albeit already developing when the new provision comes into force, has not

43. This principle should be read with 50 years, creating situations in some cases reference to the specific nature of the case in which recordings which had fallen into now before us, in which the application of the public domain under preceding legisla- a rule to a developing situation comes into tion had become newly protected as a result consideration. 14 In cases of this type, it is a of the entry into force of the new legisla- tion. In interpreting the above directive, the Court stated that '(.

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sidered to have retroactive effect. Its appli- 47. In such circumstances, I do not think cation to the future consequences of situa- there can be any doubting the fact that the tions which are not definitively settled admission of animals to collection centres means, on the other hand, that it has an and the marketing of semen represent two effect on a third party's rights to continue moments in one and the same situation, the exploitation of a sound recording where separated by a period of time correspond- the copies already manufactured have not ing to that during which the semen pro- yet been marketed and sold on that date.' 17 duced remains stored at the centre. Of these two moments, the former represents exclu- sively a condition for the application of the latter, which gives rise to the facts to which the Directive applies.

45. From all the foregoing considerations it follows that when there is a separation in 48. I therefore consider that, on the basis of the time between the coming into existence the considerations set out above, the of a legally relevant situation and the point answer to the first question for a prelimin- at which its consequences are taken into ary ruling must be that the relevant provi- account, the amendments to the rules made sions for establishing whether the certifica- after the situation in question arose but tion needed for the admission to intra- before it produced its effects must be Community trade of the semen of If de immediately applied. Focant can be issued arc those of Directive 88/407, in the version amended by Direc- tive 93/60.

50. The answer to this question should be bearing in mind the observations made in the negative. The preconditions for an earlier concerning the first question, that analogous application such as that envi- the Court has on several occasions affirmed saged by the national court are entirely that '(...) while the principle of the protec- lacking. It must be considered that recourse tion of legitimate expectations is one of the to application by analogy presupposes fundamental principles of the Community, some lacuna in the legislative provision it is settled case-law that this principle and is aimed at remedying this by applying cannot be extended to the point of gener- provisions relating to similar cases. The ally preventing new rules from applying to requirement for recourse to application by the future consequences of situations which analogy is therefore a lacuna in the system. arose under the earlier rules'. 19

In the present case, however, there was no lacuna. The absence of any transitional 53. This should be understood as meaning provisions in Directive 93/60 correspond- that there is no legitimate expectation to ing to those contained in Directive 88/407 safeguard in such circumstances because constitutes a choice on the part of the the situation regulated is still developing legislature aimed at enabling the more and thus has not yet given rise to subjective recent legislation to produce its effects situations deserving of protection. 20 immediately and thus to ensure a more effective protection of human health.

been born in a herd which, from the health- power which corresponds to the political status point of view, was at the limit of responsibilities given to it by Articles 39 legality and that, accordingly, even a mini- and 40 of the Treaty [which respectively mal restrictive amendment to the provi- became Article 33 EC and, after amend- sions would certainly have made its semen ment, Article 34 EC]' and that 'conse- no longer marketable. quently, the legality of a measure adopted in that sphere can be affected only if the measure is manifestly inappropriate having regard to the objective which the compe- tent institution is seeking to pursue (.

'(. . .) the principle of proportionality, which question we are dealing with. The most is one of the general principles of Commu- interesting point to emerge from that nity law, requires that measures adopted by judgment is the fact that scientific uncer- Community institutions do not exceed the tainty, combined with the existence of a limits of what is appropriate and necessary serious risk to human health, is acknowl- in order to attain the objectives legitimately edged to be of decisive importance as a pursued by the legislation in question; justification for particularly drastic legisla- when there is a choice between several tive intervention. 24 appropriate measures, recourse must be had to the least onerous, and the disadvan- tages caused must not be disproportionate to the aims pursued (.

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uncertainty surrounds the campaign of those amendments, which is to protect against brucellosis, particularly as regards human health. the means whereby infected animals are to be identified. Bearing in mind, then, the risks associated with the possible transmis- sion of the disease to man, the legislature's choice not to provide for a transitional 58. As regards the third question, I there- regime in Directive 93/60 — thereby mak- fore consider that the absence of transi- ing the new and more restrictive conditions tional measures in Directive 93/60/EEC governing the admission of bulls into semen does not render that directive invalid for collection centres immediately and gener- infringement of the principle of the protec- ally operative — cannot be regarded as tion of legitimate expectations or the disproportionate in relation to the objective principle of proportionality.

Conclusion

59. In light of the foregoing considerations, I suggest that the Court answer the fourth question from the College van Beroep voor het Bedrijfsleven as follows:

(1) Article 1(8) of Directive 93/60/EEC which amended the second sentence of paragraph 1(b) of Chapter I of Annex B to Directive 88/407/EEC ('The animals may not previously have been kept in other herds of a lower status') to read 'The animals may not previously have been kept in one or more herds

(4) Directive 93/60/EEC is valid inasmuch as it is not incompatible with the general principles of law, in particular the principle of the protection of legitimate expectations and the principle of proportionality.

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