C-3/00

OPINION OF MR TIZZANO — CASE C-3/00

OPINION OF ADVOCATE GENERAL TIZZANO delivered on 30 May 2002 1

Table of contents

I — Legal background I - 2649

A — Community legislation I - 2649

(1) The Treaty I-2649

B — The Commission decision I - 2660

C — The application I - 2661

III — Legal assessment I - 2661

Introduction I - 2661

A — The alleged infringement of the principle of a fair hearing I - 2662

B — The complaints as to the substance of the decision I - 2667

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(b) The necessity and proportionality of the Danish measures I-2678 Arguments of the parties I - 2678 Assessment I-2682 (c) The question of the discriminatory nature of the Danish measures I - 2684 (d) Erroneous reference to Articles 4 and 7 of Directive 95/2 I - 2685 (e) Erroneous assessment of the facts in the part relating to sulphites I-2686 (f) Failure to adopt a position under Article 95(6) EC I - 2687 C — The complaint as to the statement of reasons for the decision I-2688 Final considerations I - 2688 Costs I-2689 IV — Conclusion I-2689

realisation of the common market was for a protection. Indeed, it required the Com- long time only Article 100 of the EC Treaty mission to base its proposals for such (marginally amended by the Treaty of matters on a high level of protection. Maastricht and now Article 94 EC), which However, as these were measures to be empowered the Council, acting unani- adopted by a qualified majority, and hence mously, to issue directives for the approxi- entailed the risk of sacrificing national mation of such laws, regulations or admin- needs worthy of protection, the same istrative provisions of the Member States as article gave Member States the possibility directly affect the establishment or func- of derogating from the measures in ques- tioning of the common market. However, tion in order to protect such needs. in order to facilitate the realisation of the internal market, provided for in Article 7a of the EC Treaty (now Article 14 EC), the Single European Act subsequently intro- duced a new provision, Article 100a, which in turn underwent various amendments as a 4. Paragraph 4 of Article 100a laid down result of subsequent Treaty revisions. that:

Commission or any Member State may 3. The Commission, in its proposals envis- bring the matter directly before the Court aged in paragraph 1 concerning health, of Justice if it considers that another safety, environmental protection and con- Member State is making improper use of sumer protection, will take as a base a high the powers provided for in this Article.' level of protection, taking account in par- ticular of any new development based on scientific facts. Within their respective powers, the European Parliament and the Council will also seek to achieve this objective. 5. The Treaty of Amsterdam made sub- stantive amendments to Article 100a of the EC Treaty, replacing paragraphs 3, 4 and 5 of that article with eight new paragraphs, numbered from 3 to 10. The Article, as amended and renumbered as Article 95 EC, now reads as follows: 4. If, after the adoption by the Council or by the Commission of a harmonisation measure, a Member State deems it necess- ary to maintain national provisions on grounds of major needs referred to in Article 30, or relating to the protection of ' 1 . By way of derogation from Article 94 the environment or the working environ- and save where otherwise provided in this ment, it shall notify the Commission of Treaty, the following provisions shall apply these provisions as well as the grounds for for the achievement of the objectives set out maintaining them. in Article 14. The Council shall, acting in accordance with the procedure referred to in Article 251 and after consulting the Economic and Social Committee, adopt the measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establish- 5. Moreover, without prejudice to ment and functioning of the internal mar- paragraph 4, if, after the adoption by the ket. Council or by the Commission of a har- monisation measure, a Member State deems it necessary to introduce national provisions based on new scientific evidence relating to the protection of the environ- ment or the working environment on grounds of a problem specific to that 2. Paragraph 1 shall not apply to fiscal Member State arising after the adoption provisions, to those relating to the free of the harmonisation measure, it shall movement of persons nor to those relating notify the Commission of the envisaged to the rights and interests of employed provisions as well as the grounds for intro- persons. ducing them.

7. When, pursuant to paragraph 6, a Member State is authorised to maintain or introduce national provisions derogating from a harmonisation measure, the Com- mission shall immediately examine whether (2) The harmonisation directives to propose an adaptation to that measure.

6. Directives 89/107/EEC and 95/2/EC are 8. When a Member State raises a specific of particular relevance to the question problem on public health in a field which under examination.

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(a) Directive 89/107/EEC 9. The directive also provides for the adop- tion of particular provisions 'in a compre- hensive directive, including existing specific directives on particular categories of addi- tives' (Article 3(1)). Such specific directives should lay down, in particular, for each category the individual substances auth- orised for use and the conditions under which they may be used (Article 3(2)). 7. Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concern- ing food additives authorised for use in foodstuffs intended for human consump- tion ('Directive 89/107' or the 'framework directive') 4 is a framework directive 10. Pursuant to Article 2(3) of the directive, adopted on the basis of Article 100a of the general criteria for the use of food the EC Treaty. additives are described in Annex II, the first paragraph of which provides that:

' 1 . Food additives can be approved only provided that:

15. Lastly, Article 4 introduces a safeguard clause, worded as follows:

12. To assess the possible harmful effects of a food additive or derivatives thereof, paragraph 3 of Annex II lays down that it must be subjected to 'appropriate toxico- logical testing and evaluation. The evalu- ' 1 . Where a Member State, as a result of ation should also take into account, for new information or of a re-assessment of example, any cumulative, synergistic or existing information made since this Direc- potentiating effect of its use and the tive, or the comprehensive directive phenomenon of human intolerance to sub- referred to in Article 3, was adopted, has stances foreign to the body.' detailed grounds for considering that the use of additives in food, although it complies with this Directive or any list drawn up under Article 3, endangers human health, that Member State may

5 — The ADI is the average quantity that a person may ingest 13. Under paragraph 6 of the same Annex, each day of their life without risk to health. approval for food additives must specify 6 — See also the sixth recital. The Scientific Committee for Food was set up by Commission Decision 74/234/EEC (OJ 1974 the foodstuffs to which these additives may L 136, p. 1).

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temporarily suspend or restrict application of which is Directive 95/2, which I have of the provisions in question in its territory. already mentioned. 7 It shall immediately inform the other Member States and the Commission thereof and give reasons for its decision.

7 — The other two are European Parliament and Council 16. The lists of permitted food additives Directive 94/35/EC of 30 June 1994 on sweeteners for use were defined in three specific directives in foodstuffs (OJ 1994 L 237, p. 3) and European Parliament and Council Directive 94/36/EC of 30 June implementing the framework directive, one 1994 on colours for use in foodstuffs (OJ 1994 L 237, p. 13).

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on account of these characteristics they are the result that the quantity of the first two frequently used in wine, 8 beer, in the classes of substance decreases considerably preservation of shellfish, in vegetable and over time. Nitrosamines — the final prod- fruit-based prepared foods, jams, biscuits, uct of such degradation — are recognised dried fruit and numerous other foods. If as carcinogenic and genotoxic substances. ingested in large quantities, sulphites are harmful to health in that they can damage the digestive system; the greatest risk to human health, however, comes from the strong allergic reactions that may be induced in susceptible persons, particular asthmatics, even at low levels of absorp- tion.

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Committee indicated that although sul- mendations — that only the substances phites are not a danger to the health of listed in Annex III to that directive may the great majority of persons, they may be used in foodstuffs as preservatives and cause serious problems for asthma suf- antioxidants. Article 2(4) then laid down ferers. It therefore recommended that their that the additives listed in Annex III may be use be limited where possible to those foods used only in the foodstuffs referred to in where there is sound reason for their that Annex and under the conditions spec- inclusion in order that the number of ified therein. sulphite-containing foods does not increase, but in any case called for their presence to be indicated on the label.

11 — SCF reports, 26th series. 13 — As the table is to be found in paragraph 4 of the contested 12 — SCF reports, 38th series. decision, I do not consider it necessary to reproduce it here.

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mines both the indicative amount to be B — The Danish provisions used and the maximum residual quantity.

27. Before Directive 95/2 came into force, the Danish legislation in this regard, which 26. Pursuant to Article 9 of Directive 95/2: dated from 1973, laid down the conditions for the use of additives in foodstuffs, including nitrates, nitrites and sulphites, by defining a list of products in which such substances could be used and indicating the permitted quantities; the list was amended subsequently in view of developments in health requirements and technical needs. 'Member States shall bring into force the laws, regulations and administrative provi- sions necessary to comply with this Direc- tive not later than 25 September 1996 in order to:

In addition, the Danish Government remains firmly convinced that the Scientific II — Facts and procedure Committee for Food ought, in accordance with the declarations put forward by the Commission, to deliver an opinion on nitrites/nitrates and sulphites as soon as possible. The Government will welcome the conclusions of the Scientific Committee and reserves the right to maintain national A — The Danish reaction to Directive provisions needed to safeguard human life 95/2 a n d h e a l t h in a c c o r d a n c e w i t h Article 100a(4) of the Treaty.' 15

29. On 15 December 1994, at the time of adoption of Directive 95/2 by the Council, the Danish delegation made the following declaration to accompany its vote against 30. In accordance with that declaration, the directive: Denmark therefore decided to maintain the more restrictive national measures regard- ing nitrites, nitrates and sulphites that I mentioned above. Consequently, as required by Article 100a(4), it notified them to the Commission over the period 'The Danish delegation votes against the from July 1996 to May 1997. adoption of the European Parliament and Council Directive on food additives other than colours and sweeteners. With regard 15 — Council Document 11620/94 Add 1of 5 December 1994.

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B — The Commission decision

34. That reply, together with the statement of July 1996, complemented by the 37. While the procedure was in progress, exchange of correspondence, was con- the Treaty of Amsterdam, which as I have

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already mentioned amended inter alia applicable to nitrites, nitrates and sulphites. Article 100a of the EC Treaty, came into On the following 6 January, however, it force on 1 May 1999. By letter dated made the present application for annulment 29 July 1999, the Commission therefore of the Commission decision and for the informed the Danish authorities that their Commission to be ordered to pay the costs. notification on the use of sulphites, nitrites and nitrates in foodstuffs would now be considered within the framework of the new provision, now Article 95 EC.

40. By order of 4 October 2000 the Court granted the Kingdom of Norway and the Republic of Iceland to intervene in support of Denmark. A number of questions were put to the parties before the hearing. 38. It was on this legal authority that on 26 October 1999 the Commission based its refusal to authorise the Danish measures, holding that they did not meet the con- ditions laid down by that provision. In particular, it denied that the said measures were necessary and proportionate to the objective pursued or that they catered for a situation specific to Denmark; furthermore, I I I— Legal assessment it discerned discriminatory aspects in the measures.

43. In order to adopt a position on this ground of challenge it is necessary first to rule on the nature of the procedure leading to the adoption of a decision within the A — The alleged infringement of the prin- meaning of Article 95(4) EC. According to ciple of a fair hearing the Commission, 'the principle that the procedure must be inter partes, which applies in all administrative proceedings initiated against a person which are liable to culminate in a measure adversely affect- ing that person, is a fundamental principle of Community law, but it does not apply in 42. The Danish Government, supported on the context of the legislative process'. 17 In this point by the Icelandic Government, the opinion of the Commission, that is the contends that the Commission decision is nature of the procedure provided for by vitiated by infringement of an essential Article 95(4) and (6) EC because it is no procedural requirement because it was more than a stage in the procedure pro- allegedly adopted without complying with vided for by that article, a procedure that is the principle of a fair hearing as defined in legislative in character in that it leads to the the case-law of the Court, primarily adoption of an act with general validity. because, despite regular contacts between According to the Commission, the pro- the Danish authorities and the Commission cedure for authorising the maintenance of from the outset, the Commission did not derogating national measures should thus give the government concerned the oppor- be recognised to be of the same nature, tunity to express its views on the content or given that it may lead to a partial amend- implications of the decision before its ment of the subjective and/or objective field adoption nor did it provide it with a precise of application of the directive, with effects and complete statement of the reasons on not only for the Member State to which it is which the decision was based. Moreover, directly addressed but also for the other the Danish Government maintains that it Member States. was not put in a position to know and comment on the opinions expressed by the other Member States on the national meas- 17 — Judgment in Case T-199/96 Bergaderm and Goupil v ures it had notified. According to the Commission [1998] ECR II-2805, paragraph 58; in sup- port of this, see the judgment in Case T-521/93 Atlanta Danish Government, this is all the more and Others v EC [1996] ECR II-1707, paragraph 70.

44. I cannot concur with that conclusion, orised 18 in application of the adminis- however. It is true, as the Commission trative principle of tacit consent. maintains, that the derogation from an act with general validity, even if adopted in consideration of individual needs, entails the modification, with effect erga omnes, of the field of application of the act from which it derogates because it also indirectly affects the legal situation in the other addressees of the act.

I recall in this European Parliament and to the Council. connection that the Court has had occasion The situation is different, however, in the to clarify that, on the basis of that prin- case of the authorisation procedure under ciple, the addressee of a decision liable to paragraph 4 et seq. of Article 95 EC, which seriously affect its interests must be able to is a formally distinct procedure with char- express its views during the administrative acteristics significantly different from those procedure and hence must also be placed in of the procedure leading to the adoption (or a position to know the documents used by amendment) of the harmonisation measure the Commission. 19 In other words, it must that is the subject of the derogation. One be afforded the opportunity during the need only consider that the procedure commences when the legislative process 18 — Advocate General Saggio reached the same conclusion in has been completed, so that the Commis- the Burstein case, when he observed that 'under sion decision may even be delivered after Article 100a(4), if, after the adoption of a harmonisation measure, a Member State deems it necessary to apply the legislation has come into force.

In a similar vein, see the Opinion of the same Advocate General ments typical of an administrative pro- in Case C-319/97 Kortas [1999] ECR I-3145, point 17). cedure, so that, for example, if the Com- 19 — See in particular the judgments in Case 40/85 Belgium v mission does not issue an opinion within a Commission [1986] ECR 2321, Joined Cases C-48/90 and C-66/90 Netherlands and Others v Commission (1992] certain time-limit, the derogating provi- ECR I-565, paragraph 44, Case C-135/92 Fiskano v Commission [1994] ECR I-2885, paragraph 39, and Case sions must be deemed to have been auth- C-32/95 P Commission v Lisrestal and Others [1996] ECR I-5373, paragraph 21.

administrative procedure 'to make known the Commission authorises the requesting its views on the truth and relevance of the State to maintain derogating national facts and circumstances alleged and, if provisions will inevitably also have effects necessary, on the documents used'. 20 on the other Member States. For this reason, although Article 95 EC does not lay down any obligation in this respect, the Commission follows the practice — cor- rectly, in my opinion — of informing the other Member States that it has received an application within the meaning of the fourth paragraph of the provision and giving each of them the opportunity to express their opinion on the procedure, 22

In the case of the procedure of interest here, it seems quite plain to me that the State requesting authorisation has a direct and specific interest in the procedure and must therefore be placed in a position effectively to make known its reasons during the administrative procedure before the Com- mission. But the other Member States have an equal interest in the outcome of the 47. That having been said, I note that the procedure in question, precisely because to Commission nevertheless claims to have authorise the maintenance of derogating complied, at least de facto, with the measures limits the scope of application of principle of audi alteram partem in that a general legislative provision. Hence, any Denmark had the opportunity to set out its decision by which under Article 95(4) EC reasons during various meetings and in the exchange of correspondence which I have described in the narration of the facts. 23 In 20—Judgment in Case C-69/89 Nakajima v Council [1991] particular, after lodging its request but ECR I-2069, paragraph 108. See also more recently, the judgment in Case C-288/96 Germany v Commission before the adoption of the contested [2000] ECR I-8237, paragraph 99 et seq., in which the Court confirmed that Observance of the rights of the defence is, in all procedures initiated against a person which are liable to culminate in a measure adversely affecting that person, a fundamental principle of Commu- 22 — In its rejoinder the Commission points out that a similar nity law which must be guaranteed even in the absence of practice was followed for the Decision of 14 September any rules governing the procedure in question'. See also the 1994 concerning the prohibition of PCP notified by the judgments in Cases 85/76 Hoffmann-La Roche v Com- Federal Republic of Germany (OJ 1994 L 316, p. 43), for mission [1979| ECR 461 for a procedure involving the Decision of 26 February 1996 concerning the prohib- competition, 264/82 Timex v Council and Commission ition of pentachlorophenol (PCP) notified by Denmark [1985] ECR 849 for anti-dumping procedures and 234/84 (OJ 1996 L 68, p. 32) and, again, for the Decision of

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' decision, the Danish Government had sub- Government had knowledge of them; des- mitted its observations in the course of a pite this, the Danish Government had meeting held on 19 November 1997. More- neither requested copies nor asked to com- over, the Commission points out that it ment on them. Furthermore, according to responded to Denmark's request by insti- the Commission, the Danish Government tuting the procedure on the basis of the was already in possession of the draft information provided by the Danish auth- decision and had even given its opinion orities and in the light of the available on it in a letter dated 22 October 1999 scientific data (the SCF reports), which in addressed to Commissioners Byrne and any case were in the public domain. Liikanen.

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to be established, as the Commission has of the procedure, the decision could not noted, whether infringement of the prin- have been substantively different. In those ciple in question had an impact in the case circumstances the mere fact that the Com- in point. According to settled case-law of mission mentioned those comments in its the Court, an infringement of the rights of decision without having afforded the defence does not result in annulment of the Member State concerned an opportunity decision if it had no influence on the to comment on them does not justify a outcome of the procedure. 2 4 declaration that the decision is void.' 25

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B — The complaints as to the substance of are truly necessary to ensure the higher the decision level of protection it wants and do not exceed that purpose. It goes without saying that this is subject to compliance with the conditions for which Article 95(6) provides for verification by the Commission.

Introduction

58. Consequently, Denmark rejects the Commission's objections based on the 56. With regard to the substance, as I have absence of a situation specific to that indicated, Denmark raises various claims as country that would justify the derogation to the unlawfulness of the decision, setting at issue and goes on to dispute the assess- them in a highly diverse and complex set of ments as to the absence of the requirements arguments which it is not easy to describe of need and proportionality in the national in the order followed in the application provisions in question and their alleged without the risk of losing sight of the discriminatory nature. Lastly, Denmark essence of the dispute, the terms of which also criticises, together with some minor became clearer in the course of the case. aspects of the disputed decision, the failure Hence, in order to highlight above all the to take Article 95(6) EC into consideration. substance of the debate, I shall not slavishly follow the order used in the application but will try first and foremost to unravel the logical thread.

59. I shall follow the same chain of logic in my examination of the complaints as to substance.

namely whether or not authorisation of the 62. Hence, precisely because from the out- derogation must be subject to the existence set it represented a break with the principle of a situation specific to the Member State applied until that time with regard to requesting it. To tell the truth, the pro- harmonisation, Article 100a of the Treaty cedural debate on this question was rather could not, according to the Danish Govern- muted at first, but it became more lively in ment, be subject to the restrictive criteria the course of proceedings as the respective usually applicable to derogating provisions. positions became clearer. Instead, it has to be interpreted in the light of the political compromise of which it is an expression, and hence in the sense that it leaves the Member State concerned ample freedom to weigh the interests at stake, possibly with a different emphasis from that made by the Community legislature.

Arguments of the parties

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66. It is patently obvious, even from this brief description, that the provision in question is aimed at catering for two 67. Moving on to examine the question at distinct needs that are not always easy to issue more closely, I must first and fore- reconcile: first, to give impetus to the establishment of the common market, and secondly to ensure high standards of pro- 27 — See, among many others, the judgments in Case 222/84 Johnston v Chief Constable of the Royal Ulster Con- tection of health, safety, environmental stabulary [1986] ECR 1651, Joined Cases C-267/95 and protection and consumer protection. For C-268/95 Merck and Beecham v Europharm [1996] ECR I-6285 and Case C-285/98 Kreil v Bundesrepublik the latter, in particular, Article 95 EC Deutschland [2000] ECR I-69.

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for the purposes of a correct interpretation absence of that condition in the former. I of the provisions in question, for a series of observe, however, that such an objection reasons which I shall now attempt to would in turn rest on a premiss that is not illustrate. demonstrated and which in my opinion is debatable, namely the premiss that the silence of Article 100a (4) as to the con- ditions for authorising the derogation implies that the Member State is at com- plete liberty to assess the need for the derogation. It seems to me, by contrast, for 7 1 . First, I would p o i n t out that reasons I shall expound shortly, that in fact Article 100a(4) was not limited to the this illogical conclusion cannot be deduced hypothesis of 'maintaining' national provi- from the article's silence but that, on the sions in derogation from a harmonisation contrary, the preconditions for applying the measure; on the contrary, it referred more derogation, although not spelt out in the generally to the situation where a Member provision (which is, I repeat, less evolved State intended to 'apply' such provisions than the subsequent Article 95), must even and hence it served to cover both the then have been capable of being derived hypotheses in question, in other words from the system and that they undoubtedly both the maintenance of existing provisions included the condition as to the specific and the introduction of new ones. 28 In the nature of the situation relied upon as a subsequent Article 95 the two hypotheses basis for the derogating national measures. were explicitly separated and the general term 'apply' became the more specific terms 'maintain' and 'introduce', which in my opinion indirectly confirms that in reality Article 100a previously covered them both.

[the Member State concerned]' 29 than where those differences really lie and what those provided for in a harmonisation consequences they entail. In my opinion, directive. It is also worth recalling the they cannot but relate to the factor which reference made by Advocate General Sag- plainly distinguishes the two situations in gio, precisely in connection with question from one another, that is to say Article 100a(4), to the established principle the fact that the fifth paragraph refers to that any derogation from the principles of the introduction of derogating measures uniform application of Community law after the adoption of the Community and the unity of the market must be measure and justified by new scientific interpreted strictly. Hence, as it deals with evidence. It follows that within the frame- just such a derogation, this article cannot work of the more precise and developed but be 'narrowly construed, and its oper- derogation regime provided for in ation must be subject to stringent con- Article 95 EC the fifth paragraph of the ditions both with respect to the scope of the provision is in turn even more 'special', so justifications provided for, and to the to speak, than the preceding paragraph (as procedure for administering this safeguard to some extent is confirmed by the para- clause'. 30 graph itself when it gives precedence to that paragraph) and hence makes the hypothesis for which it provides subject to even stricter criteria than those laid down by the fourth paragraph, both as regards the 'major needs' considered — given that in this case it is possible to introduce a safeguard measure only for 'protection of the environ- ment or the working environment' — and above all as regards the conditions for operation of the provision. As I have said, the national measure must be based on 'new scientific evidence' and justified by a problem specific to the Member State 74. The fact remains, however, that concerned arising after the adoption of whereas Article 95(5) now explicitly lays the directive. down the conditions for applying the derogation for the purposes of the situation it envisages, it must be deduced from this that such conditions are not required in the situation provided for by the fourth para- graph of the same provision (as they were not for the corresponding paragraph of Article 100a). There is no doubt that paragraphs 4 and 5 of Article 95 lay down different rules, as they refer to different situations; however, it is necessary to agree

have emerged. If reference had been made in unison with the Commission, that to the only to the first condition, it would have extent that it creates 'an exception to the been possible to find an argument in favour principles of uniform application of Com- of the position criticised here, but the munity law and unity of the market', provision also demands new evidence; it is Article 95(4) EC must, like all provisions precisely for this reason that the fifth which allow derogations, 'be strictly inter- paragraph, but not the fourth, makes preted, so as to ensure that it is not express reference also to the specific nature extended to cases other than those specifi- of the problem. As the evidence in question cally provided for in it'. 31 By contrast, the could be relevant to all or many other Danish proposition, unlike that set out Member States, it became necessary here here, effects just such an extension. In any (but not in the fourth paragraph) to set out case, to me it seems very difficult to as clearly as possible a condition specific to reconcile with that interpretative principle the requesting State that is linked to the the claim of a Member State to rely on the new evidence and justifies in a special way inadequacy of the standard of protection a derogation for that State from the har- guaranteed by the Community legislature monisation measure. If this reconstruction as grounds for requesting, on the basis of a failed to convince, it would have to be unilateral assessment of the need for raising explained for what mysterious reason a that standard, authorisation to maintain or Member State must rely on a problem introduce a derogation from the provision specific to itself if it wishes to introduce and hence from the principle of unity of the derogating measures after the adoption of market. On the contrary, it seems to me the directive but not if it wants to maintain that to allow such a claim would mean existing ones, particularly if one considers transforming Article 95(4) EC into a veri- that it has also had an opportunity to table permanent opt-out clause from any defend its reasons for the latter during the harmonisation directive, in stark contrast preparation of the directive. with the principles and purposes of the system and with the logic which, in the protection of the general interest, inspires the division of powers between the Com- munity and the Member States.

conditions are necessary for the derogation may also be requested where the directive to be legitimately requested, and these was adopted unanimously and why it is cannot but consist in a problem specific to therefore not confined to States 'placed in a the State concerned for which the general minority' but can even be invoked by a measures contained in the directive are not State that has approved the directive. This able to cater. If it were a problem common means that the derogation is not necessarily to all or the majority of Member States, it linked to an adverse assessment of the would presumably already have been directive, because a Member State could resolved by the directive, but if that were consider that in general terms the level of not so, it would be necessary to verify protection guaranteed by the Community whether the conditions for challenging the legislature is adequate and for that reason directive directly were met, given that the approves it, while knowing that it has a directive must already ensure not just specific problem in this regard and there- general protection but a 'high level' of fore reserves the right to request a deroga- protection; in any case, the problem would tion. From the viewpoint of the opposite be of a general nature and it is not therefore proposition, however, a request for a possible to understand why it should be derogation from a State that approved the resolved only for the fortunate citizens of a directive would be difficult to explain, single more meticulous Member State, to given that the point of departure of that the detriment of the uniform application of proposition should be the State's negative the harmonised rules and hence of the assessment of the level of protection laid functioning of the common market. If, on down in the directive. the other hand, the level of protection were considered adequate, it is still not possible to understand why one Member State should be allowed the liberty to raise it unilaterally, even with the laudable inten- tion of ensuring an even higher level of protection for its own citizens, again to the detriment of the unity of the market, unless this State can demonstrate the existence of a situation specific to itself that justifies such consequences.

that I have no difficulty recognising the insistence on the 'context' and the 'political existence of that 'context' and of the compromise' of which Article 100a(4), and climate of concern that surrounded the subsequently Article 95(4), are supposedly negotiations on the Single European Act an expression, and which allegedly justify with regard to Article 100a. I could even the applicant's claim. I repeat in this regard cite for that purpose the declaration made that I have no difficulty recognising, by Denmark at the close of the negoti- together with Advocate General Tesauro, ations, which expresses well the intention that the possibility afforded to a Member of some Member States, in particular State to maintain national provisions after Denmark, to reserve the possibility of the adoption of a Community measure making a choice different from that of the harmonising a given matter 'is intended to Community. 32 But I do not wish to enter ensure "reinforced" protection of certain into a detailed discussion of that declar- particularly important interests and, above ation here, all the more so since it has not all, to answer the preoccupations expressed even been mentioned by the applicant by a number of countries during the

osition. All the more so if one considers that the provisions under examination already take ample account of these needs, given that for this very reason they expressly introduce a substantial deroga- tion from the established principle that where Community harmonisation has taken place in a given matter the Member States may no longer adopt unilateral 80. I feel it is more useful to say a few measures justified by the protection of the words about the Danish Government's needs referred to in Article 30 EC (see point 63 above). In the case under examin- ation, provided the conditions are met, 32 — I refer to the declaration by the Government of the such measures can be authorised, and this Kingdom of Denmark (declaration No 18 annexed to the in my opinion is already in itself a signifi- Single European Act) on Article 100a of the Treaty establishing the European Community: 'The Danish Gov- cant reinforcement of the guarantees ernment notes that in cases where a Member State is of the sought. To go further, and to translate opinion that measures adopted under Article 100a do not safeguard higher requirements concerning the working environment, the protection of the environment or the those conditions into a possibility of dero- needs referred to in Article 36, the provisions of Article 100a(4) guarantee that the Member State in question can apply national provisions.

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gations ad libitum, would not be a com- problem at issue but only to transfer it, promise but an abuse. given that even if it were shown to exist it would still be necessary to demonstrate why, in the absence of a specific need for the Member State requesting the deroga- tion, the new information should work in favour of that State and not in that of all (or most) of the other States. The fifth paragraph of Article 95 gives an unequivo- 81. Before concluding on this point, I must cal reply in this regard by demanding that also devote a few words to the debatable there also be a problem specific to the position adopted by the Commission in the requesting State; the Commission's prop- present case. After having given to under- osition, in contrast, does not give such a stand that it too considered that a factor reply or at least does not give it clearly and specific to the State requesting the deroga- unequivocally. I must also add, more tion was a necessary condition, raising it in specifically, that I find it extremely difficult the contested decision and basing one of to imagine that a directive negotiated over the main grounds for refusing authorisation a period of years can have overlooked on the absence of such a factor, in its information so crucial as to justify the submissions the Commission downgraded derogation we are discussing, and above all that condition almost to a subordinate or, that this information (or even new scientific at any event, alternative ground by evidence) can then emerge in the extremely comparison with other conditions. In its short period of time between approval of opinion, in short, the Member State invok- the directive and the request to maintain ing Article 95(4) can also confine itself to national provisions, as the case in point adducing new scientific evidence or factors demonstrates. What in fact appears normal that should have been taken into consider- in the hypothesis for which Article 95(5) ation in the Community legislation at issue caters, and thus justifies its particular if they were likely to prove that the latter wording, frankly appears rather unlikely does not ensure adequate protection. in the case we are now discussing.

provided by the Community directive, hence the need to maintain higher levels of because it is clear that that requirement is protection. These arguments are contested closely linked to the condition that there be by the Commission, which in addition a specific problem, in the sense that the detects discriminatory elements in the derogation can be authorised only if it is derogating national measures. In examin- demonstrated, as stated in Article 95(5), ing this difference of opinion, I shall seek as that protection is inadequate in relation to far as possible not to allude further to the a specific problem encountered by the State condition that a specific problem exist, concerned. In a certain sense therefore the which I have examined at length above, existence of the problem is the preliminary although this issue resurfaces several times condition for the State to be entitled to and blends with the arguments raised by request the derogation; the inadequacy of the parties on the questions now under protection is the substantive condition for discussion. granting the derogation.

84. In the light of the foregoing, I therefore consider that the Danish measures regard- Arguments of the parties ing sulphites, nitrates and nitrites should be justified by reason of a situation specific to Denmark; since such justification has not been provided, and not even relied upon, this complaint should, in my opinion, be rejected. 86. The applicant government disputes the conclusions reached by the Commission in the contested decision and defends the necessity and proportionality of its meas- ures, relying in general on the precaution- ary principle, which according to the applicant permits Member States to raise the level of protection to prevent risks to human health. (b) The necessity and proportionality of the Danish measures

88. In particular, Denmark first refers to the danger of serious allergic reactions in susceptible persons, which cannot be remedied by the incomplete Community legislation on labelling; secondly, it cites the risk of exceeding the acceptable daily intake (ADI), set in the SCF opinion of 25 February 1994 at 45-50 mg, despite the 90. The applicant government objects first fact that neither the quantity of additive that the contested decision commits a nor the list of products in which the use of manifest error where it maintains that the such quantities is permitted under the measures are not necessary in relation to directive are justified by a sufficient tech- the claimed exceeding of the ADI of nitrites nological need. Furthermore, the decision and nitrates, in that Denmark has never enunciated in the Danish measures at issue claimed that that was the justification for to reduce the population's exposure to its measures, having linked them instead to sulphites was, according to the Danish the risk arising from the degradation of Government, necessitated by the impossi- nitrites and nitrates into nitrosamines. bility of acting against the use of sulphites in wine, given that the regulation in this regard does not permit the adoption of national safeguard measures; there was therefore no other solution than to limit the use of sulphites in other products.

91. In the view of the applicant govern- ment, the directive disregards the clear 89. As to nitrites and nitrates, Denmark recommendations of the SCF, permitting responds above all to the assertions in the an excessive use of nitrites and nitrates and contested decision that the measures in the consequent formation of nitrosamines, question were neither necessary nor substances with well-known carcinogenic

94. The Commission, for its part, objects in general terms that the Danish authorities, without having produced any new data, wish to maintain the national provisions at issue on the sole basis of a different inter- pretation of the very information available 92. With regard to the reasonableness of its to the Council when Directive 95/2 was decisions, the applicant government rejects adopted. As I have stated repeatedly above, the accusations made in the contested the Commission maintains that such a decision that the measures in question are claim is not admissible unless the Member inconsistent because, in the context of a State can prove that the level of protection general reduction in the quantity of addi- laid down in the directive is manifestly tives, they permit different and higher insufficient or can cite new evidence or amounts for certain products. Denmark demonstrate the existence of factors over- points out that technological needs vary looked by the Community legislature. This from one product to another and thus did not occur in the case before the Court. depend, as the SCF emphasises, on many parameters, such as the temperature of storage and the composition of the product itself. According to the applicant govern- ment, the Danish measures simply adapted the dosage of nitrites and nitrates to the needs of the various products, which the applicant government is at pains to describe analytically. The Commission was there- 95. As to the substance, the Commission fore wrong to take the different levels of disputes the Danish accusation that it failed nitrates laid down in the Danish list for to consider that the existence of a tech- different products as a basis for accusing it nological need is the necessary precondition of inconsistency. for authorising an additive. In reality, I - 2680

according to the defendant, in the present relation between the quantity of additive case there is a technological need both for used and the formation of nitrosamines. In nitrites and nitrates and for sulphites, and particular, it repeated that the Community due account of this was taken by the legislature was fully apprised of the SCF Community directive, but not by the Dan- opinions when it adopted Directive 95/2 ish provisions. and that in reality the level of protection set by that directive accords with the con- clusions of the SCF opinion of 19 October 1990 and essentially confirmed by the subsequent opinion of 22 September 1995. The Commission recalls that in its first opinion the SCF had stated that the avail- able data on nitrosamines, which are 96. With regard to the substance of the known to be carcinogenic, indicated that Danish observations, the Commission 'aux niveaux auxquels elles ont été détec- observes first that the provisions of tées dans les aliments, les effets nocifs pour Directive 95/2 on sulphites are consistent la santé sont probablement faibles'; despite with the relevant opinions of the SCF and this, the Committee went on to recommend are therefore entirely adequate to the pro- that exposure to preformed nitrosamines in tection of public health. More specifically, food should be minimised by appropriate it objects that the issue of allergic reactions technological practices, such as lowering of has already been dealt with at Community the levels of nitrate and nitrite added to level by means of rules on the labelling of foods to the minimum required to achieve foodstuffs, so that no national intervention the necessary preservative effect and to is needed in that regard; if improvements ensure microbiological safety. However, are needed, they should be pursued when since the SCF did not indicate any par- the labelling regulations are amended, and ticular limit, either for the quantity to be certainly not by means of a derogation added or for residual quantities, the Com- from Directive 95/2. According to the mission continues, it is for the Community Commission, the same goes for the problem legislature to define the means of obtaining of sulphites in wines, which also requires, if the recommended results and setting the necessary, a specific measure in a different minimum level required, which must be 'le context. At any event, the Commission plus bas que l'on puisse atteindre'. Hence continues, by permitting the use of too low according to the Commission the Danish quantities of preservative, the Danish meas- Government's assertion that Directive 95/2 ures are not sufficient to meet the tech- does not accord with the SCF opinion and nological need addressed by sulphites. is therefore inadequate is manifestly unfounded.

inadequate, given that the maximum 100. Continuing from a general point of amounts for which they provide cannot view, I note that Denmark raised the ensure microbiological safety except in precautionary principle as a parameter for particularly safe hygiene conditions. In the the Commission's assessment of the necess- absence of the universal and complete ity and proportionality of the national adoption of appropriate prevention tech- provisions at issue. Indeed, there can be niques, such as the 'hazard analysis and no doubt but that the possibility of adopt- critical control points' (HACCP), such ing protective measures in consideration of conditions are not guaranteed in the Com- possible dangers to health derives from that munity, at least in the present state of principle; it must, however, be stated that Community law. as a rule such measures must be taken by the Community institutions, not unilat- erally by Member States, and certainly not in sectors in which a Community harmonisation measure has already been introduced. At most, in the name of that principle, the Member States can be auth- orised to adopt such measures in cases permitted by the Treaty, such as that under examination, but within (and only within) the limits permitted by the Treaty. In the present case this means that, where the Assessment safeguard clause provided for by Article 4 of Directive 89/107 does not apply, the maintenance of derogating national meas- ures requires that the conditions described in Article 95(4) be fulfilled. Obviously, if they are not fulfilled, there is no possibility of criticising the Commission decision on the grounds of infringement of the pre- 99. Turning to an assessment of the argu- cautionary principle in the context of the ments of the parties, I must first repeat, on said provision, save of course the possibility a general level, that the judgment of the of bringing separate actions for annulment necessity and proportionality of the deroga- if the conditions are met. ting national measures must be made, as the Commission notes, in the light of the standard of the harmonised legislation; that is to say, as Advocate General Tesauro observed in his Opinion in Case C-41/93, account must be taken of the fact that 'the control entrusted to the Community insti- tutions by Article 100a(4)... seems necess- arily to be inspired by more stringent criteria than those underlying the provi- sions of Article 36, in that there is no 101. Remaining on the level of principles, I possibility of not taking account of the must add one last point: contrary to the standards of protection already laid down surprising claims of the Danish Govern- by the harmonisation rules' (point 6). ment, and in contrast to the general prin- I - 2682

105. I therefore feel able to conclude that, as regards the national measures relating to nitrites and nitrates but not those relating to sulphites, Denmark has in fact demon- 103. I reach a quite different assessment, strated both that they are necessary and however, with regard to nitrates and that they are proportionate and reasonable. nitrites, in respect of which I feel able to For that reason the Danish criticism must endorse the Danish observations. therefore be held to be well founded.

34 — It is true that the SCF recommended, as it did five years previously, 'that exposure to preformed nitrosamines in food should be [reduced]... to the minimum required to achieve the necessary preservative effect and to ensure microbiological safety', but it also noted that 'the residual quantity of nitrites authorised by Directive 95/2/EC (Table I) is much higher than estimates based on the maximum 104. First, it seems to me that the Com- levels of added nitrites and nitrates which, according to the mission does not offer convincing argu- information obtained by the Committee at the time of the previous report, can be justified on technological grounds' ments for concluding that the harmonised (Opinion of 1995, pp. 3 and 22 et seq.).

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108. As to the other 45 categories, accord- ing to the applicant government their exclusion is a consequence of the limi- tations imposed by Article 95 EC. The 110. For my part, I consider that the Danish Government observes that legis- Commission is right to consider that the

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Danish measures are intrinsically discrimi- Commission to the applicant government natory, both as regards sulphites and as that traditional products which by their regards nitrites and nitrates. nature or method of production require higher levels of preservatives are to be found not only in Denmark but also in other Member States. One must therefore ask why such justifications should be valid for some and not for the others. If the method of manufacture and the conditions of production necessitate higher maximum 111. As regards the former, it appears to levels of preservative, this should apply not me that Denmark is relying for its defence only to Danish products but also to all on a distorted interpretation of the mech- traditional products of other European anism created by Article 95(4) EC. The fact regions where similar quantities of preserv- that this authorises only the maintenance of ative are added and for which there is a existing legislation obviously does not similar technological need. mean that when a Member State transposes the harmonisation directive it cannot, if necessary, partly amend the existing legis- lation in accordance with the directive but maintain the remainder. On the contrary, by providing for the possibility of authoris- ing the 'maintenance' of (even only) part of the existing legislation, Article 95 presup- 114. In the light of the foregoing consider- poses that that legislation must co-exist ations, I therefore feel able to conclude that with the compatible provisions of the both the Danish measures relating to sul- directive and with the related implementing phites and those relating to nitrites and laws. nitrates are discriminatory and entail a disguised restriction on trade between Member States.

having attributed, in paragraphs 28 and 43 out 'that the review of Directive 95/2/EC of the decision, a wrong meaning to could be initiated in several ways', includ- Article 4 of Directive 89/107 and Article 7 ing that described in Article 4 of of Directive 95/2, 35 which make it possible Directive 89/107, which may lead to to review the Community provisions in this amendment of the positive list, and that regard and to amend the positive list. provided for in Article 7 of Directive 95/2, According to the Danish Government, the which requires the Member States and the Commission was wrong to base the con- Commission to monitor the consumption tested negative decision on the presence of of additives so that the Commission may the safeguard clause and a procedure propose amendments where necessary. specifically foreseen for amending the har- monised measure, as these elements are not relevant to the assessment that the Com- mission has to make under Article 95(4). Moreover, the applicant government con- tends that the provision relating to the safeguard clause is not applicable in any 117. That complaint should therefore also way to the Danish case; whereas the be rejected. application of that clause presupposes new evidence or scientific data, the Danish request relating to Article 95(4) is based on existing SCF reports.

(e) Erroneous assessment of the facts in the part relating to sulphites

According to the Commission, on the other inadequate. It asserts that by not assessing hand, paragraph 23 of the contested explicitly whether the Danish provisions decision does not state that Directive 95/2 are a means of arbitrary discrimination or a is based on the 1994 opinion, but mentions disguised restriction on trade between it only indicatively. Member States nor whether they constitute an obstacle to the functioning of the inter- nal market, the Commission failed to meet an obligation imposed by the Treaty. Under Article 95(6) EC it should have stated its opinion on these specific aspects and could not base its decision only on the aspect 119. It seems to me that the literal tenor of concerning the protection of public health. the contested paragraph of the decision confirms the Commission's version. Even if that were not the case, however, I do not see how that circumstance could make the decision unlawful, given that any inaccur- acy is utterly marginal, particularly as the underlying directive does not necessarily require account to be taken of the ADI 36 and the ADI is merely precautionary, 37 so 121. In reality, from an examination of the that exceeding the amount would not entail decision it is clear that the Commission any actual risk. took the discrimination aspect into account; apart from that, I must none the less observe that the authorisation of national measures in derogation from a harmonisation directive adopted pursuant to Article 95(1) CE presupposes that both the positive conditions described in the fourth paragraph and the negative con- ditions set out in the sixth paragraph of (f) Failure to adopt a position under Article 95 are met. Logic therefore dictates Article 95(6) EC that where it is found that the former are not met, the preconditions for the Com- mission to reject the request are fulfilled, without it also being necessary to verify the absence of the latter. 120. Lastly, in a complaint that is, to say the least, surprising, the Danish Govern- ment contends that the position adopted by the Commission under Article 95(6) EC is

124. The Commission replies that the con- tested decision fully satisfies the obligation to provide a statement of reasons provided for in Article 235 CE, as interpreted by the 127. In summary, I feel able to conclude C o u r t of J u s t i c e , given t h a t in that the Commission had many reasons for paragraphs 20 to 34 with regard to sul- considering that the conditions for auth- phites and in paragraphs 37 and 38 and 41 orising the derogation requested by the to 44 with regard to nitrites and nitrates it Danish Government were not met. contains a reasoned exposition of the Although in justifying that conclusion the elements of fact and law which justify the contested decision does not follow a very decision. rigorous line of argument and in parts it is even open to criticism, I consider that the truly essential passages in the provision are correct and not vulnerable to the com- plaints made against it by Denmark. For that reason, I am of the opinion that the application must be dismissed in its enti- rety. 125. For my part, and leaving aside any other element, I have to observe that the complaint appears to be unfounded, 38 — See paragraphs 63, 85, 96, 106 and 109.

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Costs missions, the latter must be ordered to pay the costs.

128. Pursuant to Article 69(2) of the Rules 129. Article 69(4) of the Rules of Pro- of Procedure, the unsuccessful party shall cedure provides that the States which are be ordered to pay the costs if they have parties to the EEA Agreement shall bear been applied for in the successful party's their own costs if they intervene in the pleadings. As the Commission has applied proceedings. The Republic of Iceland and for the costs to be borne by the Kingdom of the Kingdom of Norway must therefore Denmark, which has failed in its sub- bear their own costs.