C-331/88

OPINION OF MR MISCHO — CASE C-331/88

OPINION OF MR ADVOCATE GENERAL MISCHO 8 March 1990 *

Mr President, 4. Article 2 of Directive 88/146, on the Members of the Court, other hand, provides that Member States may no longer authorize any derogation from Article 2 of Directive 81/602. However, the administration for therapeutic purposes of oestradiol 17ß, testosterone and 1. In connection with an application for progesterone may be authorized. The use of judicial review of the regulations trans­ the five hormones for fattening purposes is posing into national law Council Directive thus prohibited. Trenbolone and zeranol 88/146/EEC of 7 March 1988 prohibiting may no longer be administered even for the use in livestock farming of certain therapeutic purposes. substances having a hormonal action, 1 the High Court of Justice has referred to the Court seven questions relating to the validity of that instrument. 5. The statement of the reasons on which Directive 88/146 is based is in the following terms. First of all, the Council made two findings, that: 2. Before examining these questions, which are fully reproduced in the Report for the Hearing, I should point out that Directive 88/146 is a successor to Directive 81/602/EEC of 31 July 1981. 2 (i) the administration to farm animals of certain substances having a hormonal action was regulated in different ways in the Member States because of differing 3. Whereas Article 2 of the latter directive assessments of their effect on human in principle prohibited the administering to health vary; a farm animal, by any means whatsoever, of substances having a thyrostatic action or substances having an oestrogenic, androgenic or gestagenic action, Article 5 authorized, until a decision had been taken (ii) this divergence distorted the conditions by the Council, the continuance in force of of competition in products that are the national regulations permitting the adminis­ subject of common market organizations tering of oestradiol 17Į3, progesterone, and was a serious barrier to intra- testosterone, trenbolone and zeranol for Community trade. fattening purposes.

'the use of hormonal substances for fattening purposes should therefore be 10. As the United Kingdom explained, the prohibited'. first question in fact seeks to ascertain whether a measure may be deemed to be valid if it is said to be based on the existence 7. I should also point out that the directive of varying assessments by the Member in issue is identical to Directive States and anxieties and expectations of 85/649/EEC, 3 which the Court declared consumers, but no scientific evidence has void in its judgment of 23 February 1988 been adduced in support of those because it had been adopted in breach of assessments and anxieties. In the opinion of the Council's Rules of Procedure. 4 Certain both the plaintiffs in the main proceedings of the questions raised by the national court and the United Kingdom, the reply to this relate to matters which were decided by the question must be in the negative. But in the Court in that judgment. Others, however, United Kingdom's opinion, the unlawfulness relate to points which were not then decided of the measure stems from an infringement by the Court. In the interest of clarity, I of the principle of protection of legitimate shall deal with the seven questions in expectations rather than a breach of the sequence, even though the first five are principle of legal certainty. The manufac- interrelated and certain arguments which turers, distributors and users of the are substantially the same are adduced substances covered by the contested several times. directive were, in the United Kingdom's view, entitled to expect that a prohibition on administering them for non-therapeutic purposes would not be introduced unless it Infringement of the principle of legal certainty was based on scientific evidence showing that they were insufficiently safe or of inadequate quality or efficacy (see points 9 to 11 of the United Kingdom's obser- 8. Strictly speaking, the concept of 'legal vations). What is one to make of this? certainty' conveys the notion that there must

'When the implementation by the Council of the agricultural policy of the Community 'Consequently, only the manifestly inappro- involves the need to evaluate a complex priate nature of a measure in this domain in economic situation, the discretion which it relation to the objective pursued by the has does not apply exclusively to the nature competent institution may affect its legality' and scope of the measures to be taken but (judgment in Case 265/87 [1989] ECR also to some extent to the finding of the 2237, paragraph 22). basic facts inasmuch as, in particular, it is open to the Council to rely if necessary on general findings. In reviewing the exercise of such a power the Court must confine itself to examining whether it contains a 14. In fact, the Council had to exercise its manifest error or constitutes a misuse of discretionary power and assume its political power or whether the authority in question responsibilities in the following situation. did not clearly exceed the bounds of its discretion.'

15. On the one hand, there were scientific opinions which prompted the Commission 13. In the Stoking judgment 6 the Court to state in the seventh recital of its initial stated, in connection with a difference of proposal 7 that: opinion concerning in particular the 'expediency and effectiveness' of a measure adopted by the Council that:

'on scientific grounds, it appears that the use of oestradiol 17ß, testosterone and 'if a measure is patently unsuited to the progesterone, and those derivatives which objective which the competent institution readily yield the parent compound on seeks to pursue this may affect its legality, hydrolysis after absorption from the site of but on the other hand the Council must be application, would not present any harmful recognized as having a discretionary power effects to the health of the consumer nor in this area which corresponds to the harm the consumer by altering the charac- teristics of meat when used under the 5 — Judgment in Case 138/79 Roquette Frères v Council [1980] appropriate conditions'. ECR 3333, at p. 3358, paragraph 25. 6 — Judgment in Case 138/78 Stö/ting v Hauptzollamt Hamburi Jonas [1979] ECR 713, at p. 722, paragraph 7. 7 - OJ 1984 C 170, p. 4.

16. On the other hand, a whole series of The applicants replied that the same arguments was adduced in favour or the consideration applies to any medicament. In prohibition of these five substances. my view, however, there is a very important difference between the use of a medicament for therapeutic purposes and its massive use (a) Most of the Member States, which had in order to accelerate the growth of animals. for a long time prohibited the use of all hormonal substances, were still not convinced that these substances were harmless. The Spanish and Italian (b) Moreover, at the time of the adoption Governments confirmed during the course of the directive in issue in this case, the of these proceedings that that was still their directive of 7 March 1988, the Council had point of view. The Commission itself made in its possession the Court's judgment of 23 its initial proposal to authorize the three February 1988 in the hormones case, substances (new Article 5) subject to very mentioned above. At paragraphs 34 and 35 specific conditions, namely that the Member of that judgment the Court made some States were to ensure that the substances in remarks about the scope of the 'report on question were: the experience acquired and scientific devel- opments, accompanied, if necessary, by proposals which take these developments (i) only administered to farm animals by into account' which the Commission was implantation which was located in a required to submit to the Council under part of the animal which must be Article 8 of Directive 81/602. The Court discarded at slaughter; held that:

that scientific report concluded that the) (d) The Council was thus referred to the were safe. opinion of consumer organizations. It is common ground that in many countries of the Community campaigns have been launched by those organizations, which In addition, the Commission amended its have even called for boycotts on hormone- initial proposal to provide for the treated meat. The Commission, moreover, prohibition of all hormonal substances. stated at the hearing that the consumption of meat had already gone down on two occasions as a result of such campaigns. In that situation the Council committed no manifest error when it found that meat (c) The Council had before it the viewpoint produced without the use of hormones of the European Parliament which took the corresponded in the best possible manner to opposite stance to the Commission's initial the anxieties and expectations of consumers, proposal. As will be seen further on, the and that such a course of action was bound Parliament's opinion, given on 11 to bring about an increase in meat November 1985, was to be regarded as still consumption. having validity in March 1988. The Parliament considered that:

I - 4046

FEDESA AND OTHERS

(e) Finally, the assessment made by the 19. The applicants submitted that the Council also dealt with the question barriers to intra-Community trade stemming whether authorization of the three ' n a t u r a l ' from divergent legislation could have been substances would be likely to eliminate the eliminated by the application of Anicle 30 clandestine use of substances whose harm- of the Treaty, which prohibits measures fulness is acknowledged by everyone, and having equivalent effect to quantitative should therefore be allowed as the 'lesser restrictions. However, this is not absolutely evil', or whether only prohibition of all the certain, since it is perfectly conceivable that substances could be effectively supervised. the Court, in proceedings under Articles 169 As I shall explain below, in connection with or 177 of the E E C T r e a t y , might have the alleged infringement of the principle of decided that the conditions for the proportionality, I consider that the Council application of Article 36 were satisfied. In did not commit a manifest error in taking such a case the barriers and distortions the view that, in regard also to the possi- would have continued to exist. Unlike the bility of supervision, a general prohibition method chosen by the Council, therefore, was the solution to be preferred. that suggested by the applicants would not definitely have solved the problem.

I - 4047

OPINION OF MR MISCHO —CASE C-331/88

'the harmless or harmful effects of the use fattening purposes. The Council did not of oestradiol 17ß, progesterone, testos- exceed its margin of appreciation in taking terone, trenbolone and zeranol still have to the view that authorizing the former did not be examined in detail' (fourth recital), oblige it at the same time to permit the latter.

producers and users of these substances therefore had a 'legitimate expectation' that the use of these substances for fattening 24. Secondly, although it is true that purposes would be permitted as soon as a Directive 81/602 may have aroused hope in scientific assessment had shown that they the circles concerned that, following further were harmless. The harmlessness of tren- studies, the use of the five substances for bolone and zeranol were demonstrated a fattening purposes would be permitted, that short time after the three other substances is merely a hope and not a legitimate expec- had been shown to be safe. tation.

there is a major difference between the use paragraphs 34 and 35 of the 'hormones' of a substance for therapeutic purposes and judgment of 23 February 1988, cited above, the Court held that the Council was not its use, on a much greater scale, for bound by the conclusions of the scientific 10 — Council Directive of 28 September 1981 on the approxi- report provided for in Article 8 of mation of the laws of the Member States relating to Directive 81/602. veterinary medicinal products (OJ 1981 L 317, p. 1). 1 1 — Council Directive of 28 September 1981 on the approxi- mation of the laws of the Member States relating to 12 — P. Pescatore: 'Les principes généraux du droit en tant que analytical, pharmaco-toxicological and clinica! standards source du droit communautaire' in: Rapports du 12e and protocols in respect of the testing of veterinary congrès de la Fédération internationale pour le droit européen, medicinal products (OJ 1981 L 317, p. 16). Paris, 1986, Vol. 1, p. 35.

I-4048

FEDESA AND OTHERS

27. For all these reasons, I propose that the 31. The effect of the prohibition, they say, Court should find that Directive 88/146 is is that the beef produced is higher in fat not incompatible with the principles of legal content than that treated with h o r m o n e s , certainty and the protection of legitimate with all the ill consequences which that expectations. entails for public health. It has also caused a considerable expansion of a black market in dangerous substitute substances, which previously existed only in Member States where the prohibition was already in force. Infringement of the principle of propor- tionality

29. First of all, they emphasize that this prohibition in no way assists in achieving its stated objectives, in particular because it is 33. The measure adopted is certainly not impossible to apply in practice. Moreover, manifestly unsuitable 13 for achieving the since the danger to health is non-existent, objective pursued. Only a total prohibition less restrictive measures, such as information of all substances having a hormonal action, campaigns and labelling requirements, of whatever kind, was capable of truly would have been sufficient to allay the allaying the anxieties, whether justified or anxieties of consumers. not, of consumers. It is true that such a total prohibition does not preclude the formation of a black market and the clandestine administration of hormones. But, as the Commission emphasizes, the authorization 30. Not only does the measure adopted of only so-called 'natural' hormones would have no positive effect but, on the contrary, not have prevented the creation of a black it causes a number of disadvantages. It market for other substances which are unde- causes economic loss which is sustained first niably dangerous but cheaper. of all by the pharmaceutical companies which are no longer able to sell certain preparations, then by farmers who are denied the savings in costs and gains in productivity made possible by the use of 34. The applicants reply, however, that if it these substances, and finally by veterinarians were permitted at least to administer who are denied clinical freedom to administer the hormones and the income 13 — Sec the aforementioned Slotting judgment and the judgment in Case 59/83 Biovilac [1984) ECR 4057, they would have earned from doing so. paragraph 17.

oestradiol, testosterone and progesterone, 37. By comparing the quantities produced farmers would be less tempted to use or sold with those which, on average, are stilbenes and thyrostatic substances needed for therapeutic treatments, it is (prohibited since 1981) or mixtures of possible to detect whether the prohibition various kinds. That is possible, but it was has been infringed. for the Council to exercise its discretionary power and to weigh the advantages and drawbacks of the two possibilities available to it: a total prohibition, with the risk of a black market, or the authorization of these 38. Moreover, Article 3 of Directive 85/358 three substances, with the certainty of provides for random controls on animals on arousing fresh calls for boycotts, without, their farms of origin, particularly in order to however, eliminating the black market. detect traces of implants, together with an official control for the presence of substances the use of which is prohibited on farms. Once all the substances are prohibited it is no longer necessary to analyse the precise nature of products, and 35. Furthermore, supervision of the rules is in particular of mixtures. easier if all the substances are prohibited because then it is no longer necessary to check whether the substances used come within the category of prohibited products. 39. As regards the possibility of achieving the objective pursued by means of a less restrictive measure, the applicants claim, first of all, that it would have been possible to allay the fears of consumers by dissemi- 36. Even if the applicants are correct in nating information on the harmlessness of maintaining that it is not possible to detect the five substances and the advantages of the use of the five hormonal substances in leaner meat. But this argument presupposes question by tests on the livestock or the the solution of the precise problem on meat, owing to the presence of natural which opinions differ, namely whether the hormones, other control measures are available scientific reports demonstrate in a available to the competent authorities. It definitive and irrefutable manner that the should not be forgotten that, under Article substances in question are totally innocuous. 1 of Council Directive 85/358/EEC of 16 July 1985 supplementing Directive 81/602/EEC: 1 4

'follow' the meat of each animal from the 45. It is, however, interesting to note that slaughterhouse to the butcher or to the amongst the countries mentioned only the supermarket, and to label separately each of United Kingdom seems to have voted the numerous pieces of meat, as well as against the directive. In the observations cold-meat preparations such as sausages. In which it submitted, the Spanish Government most Member States such labelling would, expressly denies that the directive is moreover, be counter-productive, since meat discriminatory. It submits that 'that labelled in that way would be refused. argument cannot be accepted inasmuch as the very rationale for the directive is the existence of disparate rules in the various Member States. If the situation were identical in all the Member States, no 42. As regards proportionality in the harmonizing legislation would be narrow sense, that is to say the weighing of required . . . . Furthermore, no discrimi- damage caused to individual rights against nation can arise when the Community the benefits accruing to the general interest, provisions apply in the same manner in all it should be stated that the maintenance of the Member States. They contain no special public health must take precedence over any derogation in respect of any one Member other consideration. Once the Council had State which places it at an advantage over taken the view, in the context of its discre- the others' (Section III, pp. 5 and 6 of the tionary power, that it could not ignore the Spanish Government's observations). I doubts felt by many Member States, and a subscribe to these arguments, and to those large proportion of public opinion, as to the submitted to the same effect by Italy, the harmlessness of these substances, it was Council and the Commission. The entitled to impose financial sacrifices on the judgments cited by the applicants in support persons concerned. of their argument relate to situations of such a different nature that they cannot serve as precedents in this case.

adduced in connection with the preceding Inadequate statement of reasons questions and deduce from those arguments that since the measure adopted affords no benefit, it cannot contribute to the achievement of the objectives of Article 39 52. On this point the applicants in the main of the Treaty and is, consequently, in fact proceedings present argument which is intended to achieve a different objective, closely linked to the preceding question. not admitted by the Council, namely a They maintain that since the directive was reduction in beef surpluses, to be made dictated not by the reasons appearing in its possible by the decrease in production due statement of reasons but by the desire to to the fall in productivity caused by the tackle meat surpluses, this consideration measure adopted. ought to have appeared in the statement of the reasons underlying the directive, which is therefore void for failure to state 48. The applicants have produced witness adequately the reasons on which it is based. statements seeking to show that the Parliament was very exercised by the surpluses at the time when it held its debate 53. Having already established that the on the Commission's proposal, and other applicant's arguments as to the real reasons statements which are said to show that this for the directive cannot be accepted, for preoccupation was also shared by the want of adequate evidence, I am led to the Commission. conclusion that this argument must neces- sarily also be rejected. Moreover, I would recall that the Court has already held, at 49. But in the Court's judgment in Case paragraph 28 of the aforementioned 63/83 Lux v Court of Auditors [1984] ECR judgment in Case 68/86, that the preamble 2447, at p. 2465, it is stated that: to the directive gives a sufficiently clear statement of the objectives pursued. 'As the Court has repeatedly held . . . , a decision may amount to a misuse of powers only if it appears, on the basis of objective, 54. It follows that my proposed reply to the relevant and consistent [facts], to have been fifth question is also in the negative. taken for purposes other than those stated.'

obtained prior to the 'adoption' of the 60. The applicants in the main proceedings directive, are of no effect. also place reliance on the fact that the composition of the Parliament and the Commission has changed since 1984/85 57. Like the Commission and the Council, I following the accession of Spain and consider, however, that the annulment of Portugal. This consideration is of no the earlier directive by the Court, on relevance, as the Parliament and the account of a purely procedural defect Commission always act as institutions, occurring at the last stage of adoption, whatever may be their composition. could not have any effect on the validity of the procedure completed prior to the unlawful use by the Council of the written 61. Finally, the United Kingdom further procedure. Consequently, both the maintains that even in 1985 the Parliament Commission's proposal and the Parliament's should in any event have been consulted opinion remained valid in spite of the again, since the proposal was considerably annulment of Directive 85/649. amended after it had given its opinion. However, it cannot be denied that that amendment followed the direction indicated 58. As regards the Commission's proposal, by the Parliament in its opinion, which it should also be pointed out that the third favoured the total prohibition of the five paragraph of Article 149 of the EEC Treaty substances and was finally agreed to by the provides that 'as long as the Council has not Council, whereas the proposal submitted to acted, the Commission may alter its original it provided only for the prohibition of p r o p o s a l . . . '. It follows that a proposal zeranol and trenbolone. A fresh consul- 'stays on the table' until the Council has tation of the Parliament was therefore not acted (unless, of course, it has been formally necessary. withdrawn). Now, as Directive 85/649 was declared void on account of a formal defect, the Council had not acted validly on the Commission's proposal and it remained 62. It follows from all the foregoing that capable of being taken up. there has been no infringement of essential procedural requirements.

64. In this connection, regard should bt measures only in order to comply with the had first of all to the important difference directive. In some of these countries the which exists between a classic case of retro- measures in question were probably adopted activity, that is, a situation where new legis- in pursuance of the usual legislative or regu- lation suddenly becomes applicable to latory competences, as if it were a question factual situations which have already of a purely national decision. There again, occurred, and the present case, where: the annulment of the directive would not have called in question provisions of internal law and no problem of retroactivity can (i) the persons concerned were given two therefore arise. years notice that with effect from 1 January 1988 certain practices would be forbidden (Directive 85/649 was in fact 68. In the United Kingdom, on the other published in the Official Journal on 31 hand, Directive 85/649 seems to have December 1985); constituted the one and only legal basis for the provisions adopted in national law, namely the Medicines (hormone growth (ii) the practices in question were in fact promoters) (prohibition of use) Regulations prohibited in all the Member States with 1986, SI 1986 No 1876, which entered into the exception of one from 1 January force on 1 December 1986. If these regu- 1988 until the date of the Court's lations in fact became invalid by reason of judgment, namely 23 February 1988. the annulment of Directive 85/649 there was, at that time, no provision of national law prohibiting the administering to animals of the five hormonal substances, and the 65. Secondly, it should be observed, as the administering thereof was therefore not a Italian Government and the Council have punishable offence. done, that it is in principle the national implementing measures which produce effects for individuals and not the directives themselves. The directive in question, 69. As to Directive 88/146, it was moreover, contains no provision of a penal implemented by national regulations having nature. the same title (SI 1988 No 705), which entered into force only on 13 April 1988. The Council is therefore probably right to draw attention to the fact that the applicants 66. Thirdly, the annulment of a directive in the main proceedings do not seem, at any does not necessarily create a legal vacuum time, to have been subject to a provision of in all the Member States. That depends on domestic law having retroactive effect. The the nature of the measures adopted at question whether the United Kingdom has national level. failed to fulfil its obligations under the directive by not making the provisions of its national regulations retroactive need not be 67. In the case before the Court, eight examined here. Member States had already prohibited the five hormonal substances, by way of inde- pendent decisions, well before the adoption 70. These reflections do not however of the directive in 1985. The national relieve me from examining whether measures in question certainly did not Directive 88/146 must be deemed to be become invalid after the annulment of the invalid on account of the retroactive effect directive. Other Member States took such which it provides for.

74. It may be observed firt of all that the Council was evidently of the opinion that since the directive had been annulled simply 77. I consider that retroactive effect was on account of a procedural defect, it was justified by these objectives and that it was appropriate to adopt it afresh as rapidly as not necessary to state grounds, which would possible in unchanged form. That explains have required an alteration of the preamble why one finds the formula, which in the to the directive. meantime had become unrealistic, whereby

15 — See the judgment of the Court in Case 63/83 Regina v Kent Kirk [1984] ECR 2689, and also the judgment of the 78. It also seems clear to me that between Court in Case 80/86 Kolpinghuis Nijmegen [1987] ECR 3969, where the Court included lhe principle that 23 February and 7 March 1988 the persons provisions may not have retroactive effect amongst 'the general principles of law forming p a r tof Community law'. concerned, including the applicants in the 16 — See in particular the judgments in Case 99/78 Decker v main proceedings, could not 'have acquired Hauptzollamt Landau [1979] ECR 101 and, most recently, a legitimate expectation that the substances in Case C-337/88 Società agricola fattoria alimentare SpA [1990] ECR I-1 in question would be made legal' (see the

I-4055

OPINION OF MR MISCHO —CASE C-331/88

Conclusion

82. I propose that the C o u r t should reply to the H i g h Court as follows:

‘Consideration of the questions raised has disclosed no factor of such a kind as to affect the validity of Directive 88/146/EEC of 7 March 1988 prohibiting the use in livestock farming of certain substances having a hormonal action, it being understood that Article 10 thereof must be interpreted as meaning that it does not require Member States to impose penalties on individuals in respect of facts which occurred prior to the date when the provision of domestic law implementing the directive became applicable to them.'

I - 4056