C-157/96

1. This Opinion relates to two distinct cases: brain diseases characterized by the micro­ a reference for a preliminary ruling from the scopic appearance of sponge-like formations High Court of Justice, Queen's Bench Divi­ in brain tissue and by the presence in that sion (Case C-157/96) and an action brought tissue, and sometimes in other tissues, of an by the United Kingdom against the Com­ abnormal form of a protein — prion protein. mission (Case C-180/96). These diseases affect various animal species, in particular sheep (scrapie), cattle, domestic cats and farmed mink, but they also affect humans (for instance, kuru, in New Guinea, or Creutzfeldt-Jacob disease, which mainly afflicts older people). In both cases, doubts have been cast on the validity of Commission Decision 96/239/EC of 27 March 1996 on emergency measures to protect against bovine spongiform encephal­ opathy 1 (hereinafter 'the Decision'), which was notified to all the Member States on the same date. By that Decision, the Commis­ sion prohibited the United Kingdom from exporting to other Member States or third countries live bovine animals, meat of bovine animals and certain products obtained or derived therefrom. The exact nature of the infectious agents causing transmissible BSE is still unknown. According to the information currently available, BSE would appear to have its ori­ gin in the use, as cattle feed, of improperly Facts and legal background to the Decision treated sheep or bovine meat and bone-meal containing the infectious agent. The question whether the disease is transmitted by other pathways is under discussion. At present, vertical transmissibility, through the mother, or horizontal transmissibility, in particular 2. The first point to bear in mind is that by mere contact, has been established only in bovine spongiform encephalopathy (herein­ relation to certain types of transmissible after 'BSE'), better known as 'mad cow dis­ spongiform encephalopathies, such as ease', forms part of a family of degenerative scrapie. Moreover, experiments have enabled the transmissibility of some spongiform encephalopathies from one animal species to another in certain specific cases to be estab­ * Original language: Italian. 1 — OJ 1996 L 78, p. 47. lished.

3. The possibility that the agent responsible certain protection measures relating to for the bovine disease is transmissible to bovine spongiform encephalopathy and humans was considered only following iden­ repealing Decisions 89/469/EEC and 5 tification of the first case of BSE in the 90/200/EEC. By that decision the Commis­ United Kingdom, back in 1986. A number of sion imposed the following measures: a ban preventive measures were therefore intro­ on the exportation from the United King­ duced by that country. In particular, the dom to the other Member States of live cattle Ruminant Feed Ban, contained in the Bovine aged more than six months and of live cattle 2 Spongiform Encephalopathy Order 1988, which are the offspring of cows in which has since July 1988 prohibited the use of BSE is suspected or confirmed; a ban on the ruminant protein, suspected of being the exportation from the United Kingdom to the source of the contamination, in ruminant other Member States of fresh meat derived feed. Subsequent amendments of those rules from bovine animals unless it comes from have made it obligatory to notify any sus­ animals aged less than two and a half years at pected case and to slaughter any suspect slaughter or from animals which, while in cattle; moreover, they have imposed restric­ the United Kingdom, have resided only on tions on the movement of such cattle and holdings on which no case of BSE has been provided for controls on the destruction of confirmed during the previous six years or, their carcasses and an obligation to disinfect finally, unless it consists of freshly boned slaughter houses. In addition, the Bovine bovine meat in the form of muscle from 3 Offal (Prohibition) Regulations 1989 have which the adherent tissues, including obvi­ since November 1989 prohibited the sale or ous nervous and lymphatic tissues, have been use in foods intended for human consump­ removed; implementation of a proper identi­ tion of certain specified bovine offal (brains, fication system (freeze band or tattoo) and a spinal cord, spleen, thymus, tonsils and certification system guaranteeing conformity intestines) which may contain the infecting of animals with the abovementioned require­ agent. That prohibition was extended to the ments. head of bovine animals, except the tongue, by the Specified Bovine Material Order 4 1996.

5. New information relating to BSE and the 24 March 1996, in which it stated that a pre­ possibility of transmission to humans was cise measure of the risk was impossible disclosed on 20 March 1996 in a statement because of a number of 'interacting uncer­ from the Spongiform Encephalopathy Advi­ tainties, including: the magnitude of the spe­ sory Committee (hereinafter 'the SEAC), an cies barrier between cattle and man; lack of independent scientific body which advises data on levels of infectivity in a range of the United Kingdom Government. In par­ important cattle tissues, which are below the ticular, the SEAC stated that 10 cases of a level of detectability by current assays; the strain of Creutzfeldt-Jacob disease had been uneven distribution of infectivity in any tis­ identified by the CJD Surveillance Unit in sue; the time course for the appearance of Edinburgh in persons aged under 42 exhibit­ infectivity over the duration of the incuba­ ing atypical clinical and neurological signs. tion period; whether there is a dose below According to the SEAC, 'although there is which there is no risk of infection.' It no direct evidence of a link, on current data repeated the recommendation concerning the and in the absence of any credible alterna­ prohibition on the use of mammalian meat tive, the most likely explanation at present is and bone-meal in feed and on its use as fer­ that these cases are linked to exposure to tilizer on land to which ruminants had BSE before the introduction of the specific access. bovine offal ban in 1989. This is cause for great concern.' The SEAC accordingly emphasized, whilst pointing out that it was too early to predict the number of cases likely to arise in the future, that it was imperative that the measures in force for protecting public health should be properly applied and it recommended constant super­ vision to ensure the complete removal of spi­ 6. Following the statement issued on the nal cord tissue. It further recommended that same date by the SEAC, the United King­ the carcasses of cattle aged more than 30 dom informed the Commission that addi­ months should be deboned in approved tional measures had been adopted providing, establishments monitored by the Meat first, for the deboning of bovine carcasses Hygiene Service and that trimmings should aged more than 30 months in approved be classified as specific bovine offal, together establishments and a ban on the sale or use with a prohibition on the use of mammalian of trimmings for human consumption, and meat and bone-meal in feed for all farm ani­ second, a ban on the use of mammalian meat mals. It concluded that if those recommenda­ and bone-meal in feed for all reared animals. tions were carried out, the risk from eating beef was likely to be extremely small.

7. On receiving that information, the Com­ mission, for its part, consulted the Scientific Veterinary Committee, which concluded that at that time there was no evidence that BSE was transmissible to man. However, recalling that the possibility of such transmissibility 'Pending an overall examination of the situa­ could not be ruled out, the Committee rec­ tion and Community provisions adopted to ognized the need to review the adequacy of protect against bovine spongiform encephal­ the current Community measures in the light opathy notwithstanding, the United King­ of the new information adding, in particular, dom shall not export from its territory to the that, having regard to the importance of the other Member States or third countries: disease, any measure taken by the Commu­ nity to address the incidence of disease and risk of transmission was to be welcomed. Attached to that opinion is a statement by Dr Ring, one of the members of the Com­ mittee, to the effect that 'we cannot be con­ — live bovine animals, their semen and fident indeed that muscle meat from cattle embryos, does not constitute a danger for transmission 7 of BSE infection'.

— meat of bovine animals slaughtered in the United Kingdom,

Those were the circumstances in which the Commission adopted the Decision which is the subject-matter of the two sets of pro­ — products obtained from bovine animals ceedings now before the Court. slaughtered in the United Kingdom which are liable to enter the animal feed or human food chain, and materials des­ tined for use in medicinal products, cos­ 7 — Opinion of the Scientific Veterinary Committee of 22 March 1996. metics or pharmaceutical products,

— mammalian derived meat and bone-meal.' trade: the aim is to ensure that such checks are carried out at the place of dispatch only, which also involves harmonization of the basic requirements relating to the safeguard­ ing of public health and animal health. One of the requirements which it imposes on The decision also requires the United King­ Member States is to notify the Commission dom to send the Commission every two of any diseases likely to constitute a serious weeks a report on the application of the pro­ hazard to animals or to human health, and of tective measures taken against BSE (Article the measures taken (Article 9(1)). In those 3) and invites the United Kingdom to circumstances, the Commission is required present further proposals to control BSE to adopt any measures which may be neces­ within its territory (Article 4). sary, after the situation has been reviewed in the Standing Veterinary Committee at the earliest opportunity, in accordance with the procedure laid down in Article 17. The Commission is also required to monitor the situation and, by the same procedure under Article 17, to amend or repeal the decisions taken, depending on how the situation devel­ 9. The Decision is based on the Treaty, on ops (Article 9(4)). The Article 17 procedure Council Directive 89/662/EEC of 11 provides for consultation of the Standing December 1989 concerning veterinary checks Veterinary Committee, which delivers its in intra-Community trade with a view to the opinion by the majority laid down in Article 8 completion of the internal market and on 148(2) of the Treaty in the case of decisions Council Directive 90/425/EEC of 26 June adopted by the Council. The Commission is 1990 concerning veterinary and zootechnical to adopt the measures envisaged if they are checks applicable in intra-Community trade in accordance with the opinion of the Com­ in certain live animals and products with a mittee, otherwise it submits them to the view to the completion of the internal mar­ Council which adopts them by qualified 9 ket, as subsequently amended and supple­ majority or decides against them by a simple mented. majority. If the Council has taken no action within 15 days, the measures are adopted by the Commission.

11. The Decision therefore comes in the wake of several measures adopted in recent years to combat BSE, not only by the United Kingdom but also by the Commission (listed in the first recital), in particular with a view to safeguarding animal and human health in 'Whereas, under current circumstances, a the Community. The Decision was adopted definitive stance on the transmissibility of 'pending an overall examination of the situa­ BSE to humans is not possible; whereas a tion', in keeping with the obligation, laid risk of transmission cannot be excluded; down by the aforesaid directives, to moni­ whereas the resulting uncertainty has created tor the situation constantly and adjust the serious concern among consumers; whereas measures depending on how the situation under the circumstances and as an emer­ develops. gency measure, the transport of all bovine animals and all beef and veal or derived products from the United Kingdom to the other Member States should be temporarily banned; whereas the same prohibitions should also apply to exports to non-member countries so as to prevent deflections of trade;

That obligation led the Commission to adopt 10 Decision 96/362/EC of 11 June 1996 amending and relaxing the preventive mea­ sures imposed by the Decision, always 'pending an overall examination of the situa­ tion'. The Commission reached that conclu­ sion after consulting the Scientific Veterinary Committee, the Scientific Committee on whereas the Commission will carry out in Cosmetology, the Scientific Committee for the coming weeks a Community inspection Food and the Committee for Proprietary in the United Kingdom to evaluate the appli­ Medicinal Products. cation of the measures taken; whereas the significance of the new information and the measures to be taken must be subjected to detailed scientific study; 10 — OJ 1996 L 139, p. 17.

12. On the basis of the additional infor­ tallow products and products derived from mation provided, 11 Decision 96/362/EC tallow have been exempted from the export lifted the export ban with regard to bovine ban. semen, which the Scientific Veterinary Com­ mittee had considered in its opinion of 26 April 1996 presented 'no risk of transmission of BSE'. As regards other products, such as gelatin, di-calcium phosphate, amino acids and peptides, tallow, tallow products and products derived from tallow, the decision made the lifting of the ban subject to appli­ The two sets of proceedings cation of certain manufacturing methods and implementation of official controls by the United Kingdom (Article 1(2)). Further­ more, the United Kingdom was banned from exporting meat or meat products or meat preparations either for human consumption or for domestic carnivores, obtained from bovine animals which were not slaughtered Case C-157/96 in the United Kingdom, unless they come from establishments in the United Kingdom under strict veterinary control (Article 1(a)). Finally, that decision requires the Commis­ sion to carry out Community inspections, in particular as regards implementation of those official controls and thus, after consulting the Member States in the framework of the Standing Veterinary Committee, to set the date on which dispatch of the products in question may recommence (Article 1(c)). 13. The applicants in the main proceedings are the National Farmers' Union, a trade association which represents the majority of farmers in England and Wales, and nine undertakings engaged in the raising for sale, feeding, lairage, transport and export of live­ stock, bovine semen and embryos and the processing and export of beef and beef- related products. They have applied to the Essentially, the scope of the Decision has High Court of Justice, Queen's Bench Divi­ been diminished, in that sperm and, subject sion, for judicial review of various national to certain conditions, gelatin, di-calcium measures adopted by the Ministry of Agri­ phosphate, amino acids and peptides, tallow, culture, Fisheries and Food and by the Com­ missioners of Customs and Excise pursuant to Article 1 of the Decision. In addition, 11 meat exporters and an association of sheep 11 — For a detailed account of the views sought before steps exporters have intervened in support of the were taken to amend the Decision, and of the overall deve­ lopment of the situation, see paragraphs 23 to 31 of the applicants in the proceedings before the order of 12 July 1996 in Case C-180/96 R United Kingdom v Commission [1996] ECR I-3903. national court.

Case C-180/96

14. Taking the view that the only point at issue in the national proceedings is the legal­ ity, in the light of Community law, of the prohibition referred to in Article 1 of the Decision, the High Court decided that, in order to resolve the dispute pending before 15. The Decision is also the subject of a direct action brought by the United King­ 13 dom under Article 173 of the Treaty. In its action the United Kingdom seeks the 12 — It is worth noting that the National Farmers' Union and certain other undertakings operating in the beef products sector also challenged the Decision by instituting proceed­ ings under Article 173 of the Treaty before the Court of First Instance (T-76/96), seeking suspension of the opera­ tion of that Decision pursuant to Article 185 of the Treaty. 13 — In the same case the United Kingdom sought suspension of That application was dismissed by the President of the the operation of the Decision pursuant to Article 185 of the Court of First Instance by order of 13 July 1996 in Case Treaty and/or the adoption of interim measures under T-76/96 R The National Farmers' Union and Others v Article 186 of the Treaty. That application was dismissed by Commission [1996] ECR II-815. order of 12 July 1996 (cited in footnote 11).

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14 — More specifically, the United Kingdom Government has referred to a statement made by the Member of the Com­ mission responsible for agriculture and to the proposal for the amendment of the Decision, which had not yet been adopted at the time when proceedings were instituted. The United Kingdom Government has pointed out, however, in its reply, that it had no interest in the annulment of the statements of position which led to the adoption of Decision 96/362.

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OPINION OF MR TESAURO — CASES C-157/96 AND C-180/96

18. As stated earlier, in this plea the United Kingdom (as well as the applicant undertak­ ings in Case C-157/96) claims that the adop­ tion of the Decision does not fall within the scope of the powers or within the margin of discretion of the Commission. More specifi­ 19. To begin with, let me say that the plea in cally, it argues that the directives which question is based essentially on the allegation

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20. Since, therefore, it is undisputed — and 17 — It is worth noting that, according to Article 129(1) of the Treaty, 'the Community shall contribute towards ensuring a cannot in any event be disputed ·— that the high level of human health protection by encouraging cooperation between Member States and, if necessary, lend­ Commission is competent on the basis of ing support to their action' (first subparagraph) and that Directives 90/425 and 89/662 to adopt mea­ 'health protection requirements shall form a constituent part of the Community's other policies' (third subpara­ sures aimed at dealing with outbreaks of graph).

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OPINION OF MR TESAURO — CASES C-157/96 AND C-180/96

18 — Order of 12 July 1996 (cited in footnote 11), paragraph 58. 19 — See, in particular, the SEAC report of 20 March 1996.

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OPINION OF MR TESAURO — CASES C-157/96 AND C-180/96

ensure the effectiveness of the ban and of the products prepared in non-member countries requirements relating to the protection of which do not export to the Community may health in a single market. enter the territory of the Community even after a considerable length of time. Effective control of the disease in question cannot be divorced from 'containment' of the infected geographical area and therefore from a total ban on exports. That is required, or at any rate permitted, by the need to give effect to 24. Nor, proceeding along the same lines, do the relevant provisions of the directives and I attach any significance to the fact — even if to the measures adopted on that basis. relevant for the purposes of the Commis­ sion's competence and not, as I am inclined to think, for the purposes of examining the proportionality of the measures adopted — that the Member States of the Community may import meat only from 45 non-member countries and subject to the strictest con­ trols. The controls on imports from the United Kingdom are equally strict and yet, 25. In view of the fact that the measures in according to the Commission, they were not force at the time of the adoption of the sufficient — at the time of adoption and in Decision had proved inadequate or, in any view of the information received on the risk 21 event, had not been properly implemented, of transmissibility to man — to ensure and that, as matters stand, the transmissibil­ adequate protection against risks to human ity of BSE and thus the possibility that it and animal health, in contrast to the view may constitute a serious hazard to health taken on other occasions in the past. More­ cannot be ruled out, it must follow that the over, events subsequent to the adoption of Commission remained within the scope of the Decision have merely confirmed that, the powers conferred on it by the two direc­ notwithstanding the total embargo, the con­ tives serving as a basis for the Decision. The trols imposed have proved to be inadequate first plea in law raised by the United King­ and capable of being circumvented by dom must therefore be rejected. exports both to other Member States and to non-member countries.

protection of human or animal health, then it clear in stating that its adoption was neces­ fails to give proper reasons. The Commission sary — under the circumstances and subject omitted, in breach of Article 190 of the to constant verification — since a definitive Treaty, to set out the reasons why it consid­ stance on the transmissibility of BSE to ered that the measures previously adopted humans is not possible and the existence of were inadequate. that risk cannot be excluded, and because the resulting uncertainty has created serious con­ cern among consumers. The objective of the Decision is therefore the prevention of risk to the health of humans and animals and the On that point, the Commission's rejoinder is attendant concern. Furthermore, the that the fifth recital in the preamble to the Decision makes it quite clear that the SEAC Decision constitutes a clear and adequate report of 20 March 1996 disclosed new infor­ statement of reasons. mation on BSE and that the United King­ dom itself considered it necessary to take additional measures in the light of that 25 report. It follows that the information on which the Commission relied is clearly set 27. Let me begin by recalling that, as the out so as to enable those concerned to chal­ Court has consistently held, the extent of the lenge its substance and the Court to exercise duty to state reasons, laid down by Article its review of legality, with the result that the 190 of the Treaty, depends on the nature of statement of reasons for the Decision is suf­ the act in question and on the context in 21 ficient. which it was adopted. In particular, 'it must disclose in a clear and unequivocal fashion the reasoning followed by the Com­ munity institution which adopted the meas­ ure in question in such a way as to make the persons concerned aware of the justification for the measure and enable the Court to Breach of the principle of proportionality 23 exercise its power of review'. This shows, should the need arise, that failure to state reasons, which is a formal defect, must be distinguished from any allegations as to the 24 cogency of the statement of reasons.

even if lawful — could have been attained by on which to assess the adequacy or other­ measures less liable to restrict trade. On that wise of the measure at the time when it was point, the Government submits that 'the dis- decided upon, I would emphasize first of all proportionality and unlawfulness of the con­ that the Commission has a sufficiently wide tested decision are particularly obvious in measure of discretion in exercising the pow­ relation to exports to third countries, the ers conferred on it by the basic directives meat of animals from non-BSE herds, bovine and thus in determining itself, with the assis­ animals born after 1 May 1996, semen, tance of the technical bodies expressly desig­ embryos, tallow and gelatin'. In the case of nated which, in this case, were in fact con­ live animals, beef and derived products sulted, the adequacy or otherwise of the 2b exempted from the export ban imposed by measures to be adopted. However, as the Decision 94/474, as amended by Decision Court reaffirmed recently in relation to vet­ 95/287, it is abundantly clear that, as the erinary inspections imposed in the interests United Kingdom has expressly stated, the of health protection by a directive on intra- Decision is not justified by the appearance of Community trade in fresh meat, 'the Com­ a new risk connected to BSE, with the result munity institutions must, when exercising that the previous national and Community their powers, take account of the require­ measures, in so far as they were adequate and ments relating to the public interest such as appropriate, were sufficient to ensure the the protection of consumers or the protec­ protection of health. tion of the health and life of humans and ani­ mals' and that 'by virtue of that principle, 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 competent institution 27 intends to pursue'. I have had occasion to point out that this argument is contradicted by the factual cir­ cumstances which gave rise to the Decision and, in particular, by the information set out in the SEAC's report of 20 March 1996, which induced the United Kingdom itself to take additional measures. Furthermore, since that argument is based on the assumption that the Decision is inappropriate for the attainment of aims other than that of allaying Regard being had to those general consider­ concern among consumers, a concern which ations, therefore, it is necessary to examine is purportedly without foundation, it calls whether the individual measures laid down into question, albeit from a different angle, by the Decision are in breach of the principle the problem of scientific uncertainty in this of proportionality, as the United Kingdom area. and the applicants in Case C-157/96 main­ tain. The answer, let me say this at once,

30. In the first place, once it has been estab­ 31. Secondly, I do not believe it is possible lished that the Commission is competent, on to argue that the measure in question is dis­ the basis of Directives 90/425 and 89/662, to proportionate in that, unlike Decision adopt measures also in relation to trade with 94/474, it also prohibits exports of meat non-member countries, it must follow, to my derived from bovine animals which have mind, that the comprehensive ban on exports resided on holdings not contaminated with to all non-member countries is lawful, pre­ BSE, particularly in view of the difficulties cisely because it is aimed at ensuring the connected with the marking of cattle and effectiveness of the other measures imposed, controls on their movements from one herd 30 in particular the complete eradication of to another. BSE, and ultimately therefore the attainment of the priority objective of health protection. Nor is the problem altered by the fact that the Community does not import from all non-member countries, since, as pointed out earlier, the possibility cannot be ruled out of reimportation through those non-member countries from which imports into the Com­ 29 munity are allowed. A ban only on exports of bovine animals — as well as of fresh meat obtained from such animals and products derived therefrom — 28 — On this point, it should be borne in mind that the ban on the use in cattle feed of meat and bone-meal, which was which have resided on holdings in which deemed sufficient by the United Kingdom to eliminate haz­ ards to health in that it concerns the factor responsible for cases of BSE have occurred would indeed be BSE, dates back to Julv 1988. As at 31 December 1995, adequate, but only, I need scarcely add, if however, 23 148 cases of BSE had been recorded in animals born after the imposition of the ban. Admittedly, that may coupled with a reliable system of marking mean that the ban has not been adhered to, as evidenced by the inadequacy of the controls, which the United Kingdom the animals and controlling their move- itself has acknowledged, but it may also mean, and in any event it does not rule out the possibility, that contamination occurs by other means as well. In any event, it confirms the need for further, more drastic measures. 29 — Sec point 24 above. 30 — Sec the Conclusions of the Council of 29 and 30 April 1996.

31 — I would remind the Court that Commission Decision 89/469/EEC of 28 July 1989 concerning certain protection measures relating to bovine spongiform encephalopathy in the United Kingdom (OJ 1989 L 225, p. 51, as amended by Decision 90/261/EEC (OJ 1990 L 146, p. 29) required the United Kingdom to 'make full use of computer records to guarantee identification of animals' (Article 1(3)). Except in Northern Ireland, however — which makes it likely, according to recent press reports, that the export ban will be relaxed in relation to cattle from certain herds in the area concerned — that computerized system has not been intro­ duced. In its Report on alleged contraventions or malad­ ministration in the implementation of Community law in relation to BSE, without prejudice to the jurisdiction of the Community and national courts, the European Parliament's I need scarcely add, also in relation to the temporary committee of inquiry into BSE has highlighted and criticized the situation which has thus arisen. In par­ bans referred to above, that the lack of mark­ ticular, the Report states: 'Shortcomings in the British reg­ ing of animals and of controls on their istration system led to the appearance of "cesspool" farms (a question debated in the UK Parliament). These farms, movements makes it impossible to establish which already had a high incidence of BSE, bought animals in the first stages of the disease and received compensation with certainty whether a particular animal, for the slaughter of the diseased cattle. The farms which sold the sick animals eluded the restrictions by concealing their true health situation. This undermined the reliability of statistics on the disease and made it difficult to study and control it. In addition, it reduced the effectiveness of the 33 — Order of 12 July 1996 (cited in footnote 11), paragraph 70. Community regulations, subjecting consumers to a risk that could have been avoided. The failure to apply the rules on 34 — As stated earlier, such transmissibility has, however, been branding, registration and control raises doubts as the demonstrated in relation to scrapie, which renders heredi­ validity of any selection cull programme of the kind envis­ tary transmission plausible in the case of BSE as well. aged at the Florence summit' (Doc. PE 220.544/fin/A, 35 — As at 31 December 1995, 933 cases of BSE were found in Results of the inquiry, p. 11). animals which were the offspring of infected mothers but which were born after the entry into force of the ban ín 32 — The information furnished by the Commission, to the effect question. In such cases, therefore, it is difficult to ascertain that it was impossible to identify the herd of origin in as whether transmission of the disease was hereditary or the many as 11 000 cases of animals with BSE, has not been result of failure to comply with the ban in question, and chalfengcd. consequently the result of eating contaminated feed.

34. Finally, and for the sake of completeness, I would point out that the alternative mea­ 33. Fourthly, there remains to be considered sures less liable to restrict trade, advocated the need for the ban on exports of sperm and by the United Kingdom and considered by it certain derived products such as gelatin and to be as least as effective as those under dis­ tallow. The ban has meanwhile been lifted, cussion here, are too vague to be seriously by Decision 96/362, both in relation to taken into consideration. The United King­ 3 sperm — inasmuch as additional information dom Government refers 8to a consumer permitted the conclusion to be drawn that information programme, whose impact on this product does not present any risk of the eradication of BSE I am, however, unable transmissibility — and in relation to tallow to gauge, to measures similar to those and gelatin, provided they arc obtained by already adopted unilaterally by the United specified manufacturing methods and subject Kingdom itself, but whose effectiveness has 37 39 to strict controls. But that fact, I need proved questionable, and to stricter mea­ hardly point out, is neither decisive nor rel­ sures, of the kind in fact adopted by the evant for the purposes of this case, in that Commission and challenged by the United the lifting of the ban cannot be considered Kingdom. per se to point to the conclusion that there was no need for it in the first place with the result that the principle of proportionality was infringed. Breach of the principle of non-discrimination and incompatibility with Article 39(1) of the Treaty

40(3) of the Treaty, in terms of discrimi­ view to the completion of the internal mar­ nation either between producers in the ket and therefore affects trade between United Kingdom and producers in other Member States. However, it cannot be Member States of the Community or denied that a marketing ban of that kind, between consumers in the United Kingdom unless accompanied by drastic measures, and consumers in other Member States. With such as the slaughter of all the heads of cattle regard to the first aspect, suffice it to note within the national territory (a measure that 97.9% of the cases of BSE in Europe which would indeed be disproportionate), were recorded in the United Kingdom, with would have been very expensive to monitor the result that breeders in that country are and its effectiveness would not have been certainly not in the same position as those guaranteed. Containment of the geographical operating in other Member States. In par­ area in which the disease developed, in order ticular, the pockets of BSE existing in other to bring it under control, was therefore the Member States are so small that it would be only appropriate means of preventing the absurd to take the view that the same mea­ free movement of the products in question sures must also be applied there. On that from causing serious injury to animals and point, it is worth recalling that, as the Court human health. has consistently held, the principle of non­ discrimination between producers or con­ sumers within the Community, which is a specific enunciation of the general principle of equality, requires that 'similar situations must not be treated differently unless differ­ 40 entiation is objectively justified'.

particular, an inescapable requirement also in latter require the Commission not only to relation to the aims pursued by the common adopt the measures necessary for the animals agricultural policy. Furthermore, the mea­ and products expressly referred to, but also sures aimed at guaranteeing health protection to adopt measures, 'if the situation so cannot fail to enhance consumer confidence requires, for the products derived from those in the quality of the products and thus lead animals' (Article 10(4) of Directive 90/425) to an increase in consumption and conse­ or 'for the originating products or products quently in trade and production, which can­ derived from those products' (Article 9(4) of not but contribute to the attainment of the Directive 89/662). It is also allegedly in objectives referred to in Article 39(1) of the breach of the duty to state reasons, since Treaty. In those circumstances, the allegation there is no link between the provision in made by the United Kingdom is entirely question and the relevant recital in the pre­ devoid of substance. amble, which merely refers to the expediency of banning the transport of all products derived from beef and veal from the United Kingdom. Finally, and in any event, the United Kingdom claims that the Commis­ sion had no power to impose the ban in rela­ tion to the export of certain products such as gelatin, di-calcium phosphate, amino acids Validity of Article 1, third indent, of the and peptides, which arc not included in Decision Annex II to the Treaty, the reason being that the directives serving as a basis for the Decision, which are in turn founded on Article 43 of the Treaty, can only be inter­ preted as applying solely to those agricul­ tural products listed in Annex II to the Treaty.

38. Given that Community legislation, like national legislation, must be sufficiently clear and its application foreseeable to those who 43 are subject to it, let me add that the Decision is addressed to the United King­ dom which, having regard to its detailed knowledge of the situation, monitored in close contact with the Commission, could not have been unaware, if only as a result of discussions within the Veterinary Commit­ tee, of the products covered by the Decision. 39. Finally, the United Kingdom submits Having said that, moreover, I do not con­ that if Directives 90/425 and 89/662 were sider that the United Kingdom is justified in interpreted as applying also to products fall­ claiming that the provision in question lacks ing outside Annex II to the Treaty, those an adequate statement of reasons and is directives would have to be considered therefore in breach of Article 190 of the invalid since Article 43 of the Treaty does 44 Treaty. not empower the Council to adopt directives which apply to products not listed in the annex in question. The Commission, on the other hand, contends that Article 43 consti­ tutes the correct legal basis also in the case of directives which cover products not listed in the annex, to the extent to which they are As for the fact that the Commission thus merely ancillary products. The Council has exercised powers not vested in it, I will con­ endorsed that argument, emphasizing above fine myself to the view, shared by the Com­ all that Annex II not only refers to live ani­ mission, that the expression 'derived prod­ mals and to the majority of products of ani­ ucts' used in the basic directives may (and mal origin but also contains a catch-all head­ must) be interpreted as covering all products ing which covers 'animal products not and materials obtained from bovine animals. elsewhere specified or included'. It has also It would be paradoxical if a product manu­ pointed out that the allegation in question factured from beef could not be classified as concerns products in respect of which the ban has already been lifted by Decision 96/362. 45 43 — See, amongst others, Case 70/83 Kloppenburg [1984] ECR 1075, paragraph 11, and Case C-325/91 France v Commis- sion [1993] ECR I-3283, paragraph 26. 44 — See, in particular, the observations set out in points 26 and 27 above. 45 — See, however, footnote 37.

Examination of the question raised has not disclosed any factor capable of calling in question the validity of Article 1 of Commission Decision 96 / 239 / EC of 27 March 1996 on emergency measures to protect against bovine spongiform encephalopathy.

46 — See Case C-11/88 Commission v Council [1989] ECR 3799 — summary publication.

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