61992C0359

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My Lords,

1. In this case, Germany challenges the validity of Article 9 of Council Directive 92/59/EEC of 29 June 1992 on general product safety (1) (hereafter "the Directive"). The Directive was adopted under Article 100a of the Treaty, as part of the Community' s programme to complete the internal market by 31 December 1992.

2. Article 100a provides that:

"1. ... The Council shall ... 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 establishment and functioning of the internal market.

...

3. The Commission, in its proposals envisaged in paragraph 1 concerning health, safety, environmental protection and consumer protection, will take as a base a high level of protection.

...

5. The harmonization measures referred to above shall, in appropriate cases, include a safeguard clause authorizing the Member States to take, for one or more of the non-economic reasons referred to in Article 36, provisional measures subject to a Community control procedure."

3. The German Government submits that in adopting Article 9 of the Directive the Council exceeded its powers under those provisions. Before considering in more detail the grounds of invalidity alleged by the German Government, however, I will first set out the relevant provisions of the Directive.

The Directive

4. The purpose of the Directive, as explained in its preamble, is to establish a general safety requirement applicable throughout the Community to all consumer products not covered by more specific safety provisions. If all Member States adopt such a requirement, disparities between national legislations which are liable to create barriers to trade and distortions of competition within the internal market will be prevented. A high level of protection of safety and health will also be ensured, as required by Article 100a(3) of the Treaty.

5. According to the preamble, Member States must ensure that they have the power to organize the withdrawal of dangerous products already placed on the market. The Commission must moreover be informed of any measure restricting the placing on the market of a product or requiring its withdrawal, except for measures with purely local effects.

6. Recitals 17 to 20 of the preamble relate specifically to the provision contested in these proceedings; they are in the following terms:

"... it is primarily for Member States, in compliance with the Treaty and in particular with Articles 30 to 36 thereof, to take appropriate measures with regard to dangerous products located within their territory;

... in such a situation the decision taken on a particular product could differ from one Member State to another; ... such a difference may entail unacceptable disparities in consumer protection and constitute a barrier to intra-Community trade;

... it may be necessary to cope with serious product-safety problems which affect or could affect, in the immediate future, all or a large part of the Community and which, in view of the nature of the safety problem posed by the product cannot be dealt with effectively in a manner commensurate with the urgency of the problem under the procedures laid down in the specific rules of Community law applicable to the products or category of products in question;

... it is therefore necessary to provide for an adequate mechanism allowing, in the last resort, for the adoption of measures applicable throughout the Community, in the form of a decision addressed to the Member States, in order to cope with emergency situations as mentioned above; ... such a decision is not of direct application to economic operators and must be incorporated into a national instrument; ... measures adopted under such a procedure can be no more than interim measures that have to be taken by the Commission assisted by a committee of representatives of the Member States; ... for reasons of cooperation with the Member States, it is appropriate to provide for a regulatory committee according to procedure III(b) of Decision 87/373/EEC. (2)"

7. Article 1(1) of the Directive states that:

"The purpose of the provisions of this Directive is to ensure that products placed on the market are safe."

Article 1(2) provides that the Directive applies in so far as there are no specific provisions of Community law governing the safety of the products concerned.

8. Articles 3 and 4 of the Directive impose a broad requirement on Member States to ensure that only safe products are placed on the market, and to require producers to supply relevant information about possible risks. By Articles 5 and 6, Member States are required to adopt appropriate measures to make producers and distributors comply with their safety obligations, and are required in particular to ensure that they themselves have the necessary powers, as specified in Article 6(1).

9. Article 7 requires a Member State to notify the Commission if it adopts a measure restricting or prohibiting the sale of a product. The Commission then consults with the parties concerned and, if it concludes that the measure is justified, informs all the Member States accordingly. If the Commission concludes that the measure is not justified it informs the Member State which adopted the measure in question.

10. Title V of the Directive (Articles 8 to 12) is entitled "Emergency situations and action at Community level". Article 8 requires Member States to notify the Commission of emergency measures being taken to prevent, restrict or impose conditions on the marketing or use of a product. The Commission in turn informs the other Member States, who inform the Commission of any measures adopted.

11. Article 9, which it will be recalled is the provision contested in the present proceedings, provides as follows:

"If the Commission becomes aware, through notification given by the Member States or through information provided by them, in particular under Article 7 or Article 8, of the existence of a serious and immediate risk from a product to the health and safety of consumers in various Member States and if:

(a) one or more Member States have adopted measures entailing restrictions on the marketing of the product or requiring its withdrawal from the market, such as those provided for in Article 6(1)(d) to (h);

(b) Member States differ on the adoption of measures to deal with the risk in question;

(c) the risk cannot be dealt with, in view of the nature of the safety issue posed by the product and in a manner compatible with the urgency of the case, under the other procedures laid down by the specific Community legislation applicable to the product or category of products concerned; and

(d) the risk can be eliminated effectively only by adopting appropriate measures applicable at Community level, in order to ensure the protection of the health and safety of consumers and the proper functioning of the common market,

the Commission, after consulting the Member States and at the request of at least one of them, may adopt a decision, in accordance with the procedure laid down in Article 11, requiring Member States to take temporary measures from among those listed in Article 6(1)(d) to (h)."

The measures in Article 6(1)(d) to (h) referred to in that provision include measures restricting or prohibiting the sale of the product concerned, withdrawing or destroying the product, or issuing appropriate notices or warnings.

12. Contrary to the views expressed by both the German Government and the Council, it is doubtful whether Article 9 gives the Commission any power to require Member States to withdraw measures they have already taken. Similarly, where the Commission exercises its powers under Article 9, a Member State does not appear to be precluded from introducing or maintaining more stringent measures. In any event, however, it is clear that the measures taken must be compatible with the Member State' s obligations under the Treaty, and in particular Articles 30 and 36.

13. Article 10 of the Directive establishes a Committee on Product Safety Emergencies, and Article 11 lays down the procedure to be followed, involving that committee, for the adoption of the measures referred to in Article 9. By Article 11(2), the validity of any measures adopted is limited in the first instance to a maximum period of three months.

The grounds of annulment

14. The essence of the German Government' s case is that Article 100a of the Treaty provides no legal basis for a provision, such as Article 9, which gives the Commission the power to require the Member States to take certain forms of specific action. The German Government considers that, in view of the action which can be required by a decision under Article 9, that provision is contrary to the division of powers between the Community institutions and the Member States.

15. In support of its contention that Article 9 of the Directive is invalid, the German Government relies upon three grounds. In the first place, it submits that Article 9 does not come within the scope of the power, given by Article 100a(5) of the Treaty, to include a "safeguard clause" in measures adopted under Article 100a; that is to say, a clause authorizing Member States to take provisional measures subject to a Community control procedure. (3)

16. Alternatively, the German Government submits that the adoption of Article 9 does not fall within the scope of the Council' s general powers under Article 100a(1) of the Treaty, combined with its duty under Article 145 to confer implementing powers on the Commission. That submission is foreshadowed in the German Government' s application, but is more fully developed in its reply, in response to arguments put forward by the Council in its defence.

17. Finally, the German Government argues that Article 9 is in any event disproportionate to the aim pursued, inasmuch as that aim could equally well be achieved by means which are less restrictive of Member States' powers to regulate the sale of products on their territory.

18. I shall consider each of those submissions in turn.

(1) The scope of Article 100a(5)

19. Despite the prominence given to it in the German Government' s application, it seems to me that the submission based on Article 100a(5) is not of central importance to the present case. The Directive does not itself refer to Article 9 as a safeguard clause, or give any indication in its preamble that the provision was adopted pursuant to Article 100a(5). Moreover, the Council does not seek to rely upon Article 100a(5) in its defence.

20. The scope of Article 100a(5) has not hitherto been considered by the Court. But it seems clear that Article 100a(5) does not give the Council any powers additional to those already enjoyed under Article 100a(1). For in requiring the Council to include, in appropriate cases, a safeguard clause authorizing Member States to take provisional measures subject to a Community control procedure, Article 100a(5) does no more than give formal recognition to a long-standing practice of the Council in adopting harmonization measures under Article 100 of the Treaty. (4) Even though Article 100, unlike Article 100a, does not confer any express power to include safeguard clauses in harmonization measures, there does not appear to be any doubt that the Council enjoyed such a power even before Article 100a was inserted into the Treaty by the Single European Act. Such a power could of course only be used to permit Member States to take measures which are compatible with the Treaty.

21. An example is provided by Article 5 of Council Directive 74/63/EEC, (5) which harmonizes the maximum permitted levels of certain substances and products in feedingstuffs. Article 5(1) of Directive 74/63 permits a Member State provisionally to impose maximum levels not specified in the directive, where it considers that there is a danger to health; it must however immediately inform the Commission and the other Member States. By Article 5(2), a decision may then be taken to amend the directive in accordance with a committee procedure.

22. That provision was considered by the Court in Tedeschi v Denkavit. (6) As the Court explained:

"Where, in application of Article 100 of the Treaty, Community directives provide for the harmonization of the measures necessary to ensure the protection of animal and human health and establish Community procedures to check that they are observed, recourse to Article 36 is no longer justified and the appropriate checks must be carried out and the measures of protection adopted within the framework outlined by the harmonizing directive.

...

Within the context of the harmonization which has been brought about, Article 5 [of Directive 74/63] however permits Member States provisionally to prevent the marketing on their territory of feeding-stuffs which contain substances which may be undesirable for animal or human health although they are not mentioned in the annexes to the directive.

Although Articles 6 and 9 of the directive provide that, following a Community procedure, it will be possible to amend the list of undesirable substances on the basis of the development of scientific or technical knowledge, it was however justified in also providing for the means of remedying a lacuna in the harmonized legislation when a danger requiring immediate action arises." (7)

23. Clearly, a clause permitting Member States to take provisional measures in derogation from the rules laid down by a directive will often be appropriate where the directive harmonizes provisions connected with health or safety. For, in the absence of such a clause, the ability of a Member State to respond to emergency situations would be seriously impaired. Such a clause will be particularly appropriate where the directive aims at a high level of protection, as in the case of measures adopted under Article 100a. (8)

24. Thus it appears that the purpose of Article 100a(5) is to ensure that the Council continues to follow the practice of inserting appropriate safeguard clauses in harmonization measures. (9) Although safeguard clauses may take a variety of forms, such clauses typically consist of two linked provisions: a provision which authorizes Member States to take provisional measures in derogation from the harmonized requirements of the directive, subject to immediate notification of the Commission, and a provision which permits the Commission to apply the measures at the Community level by means of a committee procedure. (10) In other cases, Member States are not only permitted to withdraw a product from the market, but in some circumstances are required to do so even where the product conforms to the harmonized standards which will normally entitle it to circulate freely; a procedure is then provided for the revision of the harmonized standards where they have been shown to be inadequate. (11)

25. However, the provision contested in the present proceedings does not resemble any of the safeguard clauses discussed above. The reason for that is clear. Unlike the usual kind of harmonization measure, the Directive does not create any presumption that products conforming to the requirements of the Directive must be able to circulate freely within the Community. The aim of the Directive is not to ensure that products placed on the market conform to particular requirements, but simply to ensure that such products "are safe" (see Article 1(1)), that is to say that they conform to the "general safety requirement" laid down by Articles 3 and 4. That requirement, in turn, is to be assessed in terms of specific rules of national law, or, in the absence of such rules, in terms of such matters as voluntary national standards giving effect to a European standard, and Community technical specifications.

26. Unlike other directives which impose obligations in relation to specific products, the Directive does not lay down any presumption that products conforming to a particular set of harmonized standards are safe. (12) There is accordingly no need for a clause enabling Member States to take provisional measures, on grounds of health or safety, in derogation from the requirements of the Directive. The aim of the Directive is on the contrary to ensure that Member States set up an appropriate system of supervision and control which will enable them to prevent unsafe products being placed on the market, and to respond if necessary to emergency situations. Article 9 enables the Commission to require the Member States to so respond.

27. It follows from the above that Article 9 is not a safeguard measure based on Article 100a(5) of the Treaty. The question then is whether the Council was able to adopt it under the general powers given by Article 100a(1) of the Treaty.

(2) The scope of Article 100a(1)

28. The German Government submits that the Council would have no power, under Article 100a(1), itself to adopt a decision of the kind specified in Article 9 of the Directive. It submits that the contested provision is accordingly invalid, in that it purports to delegate to the Commission a power which the Council does not itself enjoy.

29. The German Government concedes that powers of the kind given by Article 9 may be useful in the context of the internal market. As the Council points out, one consequence of the abolition of border controls is that it has become more difficult for Member States, acting individually, to prevent the circulation of unsafe products on their territory. Thus a product which is for instance prohibited in one Member State may be freely imported from another Member State in which it is subject to no such restriction. The powers given by Article 9 permit serious and immediate risks to the health and safety of consumers to be confronted, where necessary, at a Community level, thereby ensuring that the completion of the internal market does not have an adverse effect on the level of protection.

30. There therefore can be no doubt that, as regards the objective pursued, Article 9 of the Directive lies within the scope of Article 100a, which as we have seen provides for the adoption of measures which have as their object the establishment and functioning of the internal market. The German Government argues however that a decision taken under Article 9 cannot properly be described as a measure of harmonization; such a decision would accordingly lie outside the scope of Article 100a.

31. In developing that submission, the German Government relies upon a distinction between harmonization measures, on the one hand, and measures of application, on the other. (13) The German Government suggests that Article 100a can only be used to harmonize normative provisions; it cannot be used to ensure the uniform application of such provisions to individual cases. In its view, a decision taken under Article 9 of the Directive has the latter function, since it may for instance require Member States to withdraw a particular product or product batch; such decisions accordingly lie outside the scope of the Council' s harmonization powers. Thus the Council cannot delegate such a power to the Commission in a measure adopted under Article 100a.

32. That argument cannot be accepted. In the first place, it is clear that Article 100a, as the German Government accepts, is not limited to the harmonization of legislative provisions. Like Article 100, Article 100a refers expressly to the harmonization of administrative provisions as well as those laid down by law or regulation. Thus harmonization measures can include requirements that administrative authorities take certain forms of action, for instance the issuing of warnings or the withdrawal of certain kinds of product.

33. Furthermore, there can be little doubt that Article 100a may be used to harmonize provisions, whether legislative or administrative, which prevent particular products from being placed on the market. Indeed, the harmonization of such provisions forms an important part of the internal market programme. Thus it may, for example, be necessary to draw up lists of products or substances which cannot be contained in food flavourings, (14) or in additives or extraction solvents, (15) or in cosmetics. (16) It will then frequently be necessary to delegate to the Commission powers to adapt such provisions in the light of the latest technical knowledge. (17) In some cases, however, the Commission may be given a power to adapt the directive only where emergency measures have previously been taken by a Member State. (18)

34. Of course, the fact that the Council has previously included such provisions in measures adopted under Article 100a of the Treaty does not in itself show that the Council has such a power. Such examples do however demonstrate the extent to which the effectiveness of Article 100a would be impaired if the German Government' s interpretation of Article 100a were to be accepted.

35. The German Government attempts to distinguish provisions of the kind just mentioned from the provision at issue in the present case. It points out that, unlike the former kind of provision, Article 9 does not enable the Commission to amend the terms of the Directive in order to adapt it to technical progress. Rather, the German Government suggests, the exercise of the powers given by Article 9 involves an application of the general safety requirement laid down by Article 3 to a specific case: for instance, the prohibition of a particular product. Thus it is significant, in its view, that the Directive does not itself contain a list of prohibited products. It seems to me, however, that the distinction relied upon by the German Government is a purely formal one, and cannot possibly affect the validity of the contested provision. There can be no difference in substance between a power to amend a list of products prohibited by a directive, and a power to adopt a separate decision addressed to the Member States having precisely the same effect.

36. On the other hand, it seems to me that the German Government is correct to draw a distinction between harmonization measures, on the one hand, and measures of application, on the other. It is one thing to lay down rules which must be uniformly applied in all Member States, another to take the decisions which apply the rules to individual cases. It is clear that, under certain provisions of the Treaty, the Council may delegate to the Commission both the power to lay down rules and the power to take individual decisions. (19) Article 100a, in contrast, is concerned exclusively with the harmonization of national provisions. It follows that Article 100a may be used only to adopt measures which lay down uniform rules; the application of those rules to individual cases is then a matter for the national authorities.

37. As the Council points out, however, decisions adopted under Article 9 of the Directive are indeed measures which require application by national authorities. The decisions may of course be highly specific, in that they may require the withdrawal of a particular product or product batch which has been found to be unsafe. None the less, it seems to me that they are accurately described as measures of harmonization. For the effect of a decision under Article 9 is to require each Member State to ensure that all instances of the product in question are withdrawn from the market. Thus a decision under Article 9 lays down a uniform rule which is to be applied by the authorities of the Member States. That, in my view, is sufficient to refute the German Government' s principal contention.

38. In its observations on the Commission' s intervention, the German Government puts forward a further argument in support of its thesis that a decision under Article 9 of the Directive cannot be regarded as a harmonization measure. It suggests that such a decision might be of "direct and individual concern" to the manufacturer or distributor of the product, within the meaning of Article 173 of the Treaty. The German Government argues that such a decision must accordingly be regarded as a measure of individual application rather than of harmonization. In my view, however, the fact that a decision might be of individual concern to a particular undertaking does not in itself prevent the decision from being a harmonization measure, as long as its function is to harmonize national provisions for the benefit of the internal market.

39. I cannot therefore accept that a decision taken under Article 9 would be the kind of measure which is inconsistent with the division of powers between the Community institutions and the Member States. The German Government suggested at the hearing that such a measure could not be taken by the German Federal authorities in relation to the Laender; but it seems to me that such an analogy with the division of powers under the German constitution is beside the point. The powers of the Community institutions are to be sought in the provisions of the Treaty. Those powers include the power to harmonize national provisions given by Article 100a. It is sufficient therefore that decisions taken under Article 9 of the Directive can be accurately described as harmonization measures.

40. It follows in my opinion that the German Government' s second ground of invalidity is equally to be rejected. I accordingly turn to the third ground, namely infringement of the principle of proportionality.

(3) Proportionality of the contested provision

41. The German Government submits that the contested provision violates the principle of proportionality, in that its aim could be attained by means less onerous for the Member States concerned. In particular, the German Government argues that it is unnecessary for the Commission to be given the power to take a binding decision. In its view, the aim pursued by the contested provision could equally well be achieved by the Commission issuing an opinion or a recommendation. The German Government suggests that, if the opinion or recommendation were not followed, the Commission could then bring proceedings under Article 169 of the Treaty. It adds that such a course of action would not result in undue delay, given the Court' s power to make an order for interim measures under Articles 185 or 186 of the Treaty.

42. In my view, those submissions are misconceived. In the first place, the whole point of Article 100a is to enable national provisions to be harmonized without the need for a multiplicity of infringement actions. In any event, it is difficult to see how the Commission would be able to bring Article 169 proceedings against a Member State which failed to follow an opinion or recommendation, which are of course expressly stated by Article 189 of the Treaty not to be binding. Thus the German Government does not explain how the Commission would be able to bring infringement proceedings against a Member State which had, for instance, refused to prohibit the sale of a particular product. As the Council points out, such a refusal could not be contrary to Article 30 of the Treaty. Rather, it is the prohibition of the product which would, if anything, require justification under the Treaty as a restriction on the free movement of goods.

43. Furthermore it is doubtful whether the Commission could in those circumstances bring proceedings against a Member State for breach of the general safety requirement laid down by the Directive. It is true that Articles 3 and 4 of the Directive require Member States to lay down a legislative framework within which producers and distributors can be required to take the appropriate measures. Similarly, Articles 5 and 6 require Member States to establish authorities with the appropriate powers and responsibilities, and Articles 7 and 8 impose certain information requirements on the Member States. Article 14 lays down various procedural requirements. However, it seems to me that the only provision under which specific obligations may arise in relation to a particular product is Article 9 itself.

44. None the less, in its reply the German Government suggests that the Commission could bring proceedings against a Member State which was in breach of its obligations under Articles 5 and 6 of the Directive. It is true that a Member State would be in breach of those obligations if it failed to adopt the necessary laws, regulations and administrative provisions, or to nominate the appropriate authorities to monitor compliance and impose suitable penalties (Article 5), or if it failed to ensure that it had the powers to adopt appropriate measures (Article 6). It is clear, however, that those provisions could not give rise to an obligation to withdraw a particular product from the market. In the absence of a decision taken under Article 9 of the Directive, it would be for the national authorities of each Member State to decide what measures should be taken to deal with a real or apparent risk.

45. It follows that, in the absence of Article 9, the Commission would not have the power to ensure that an unsafe product was subject to the same prohibitions or restrictions in every Member State. Contrary to the submission of the German Government, therefore, Article 9 cannot be regarded as unnecessary for its purpose.

46. Nor am I persuaded by the German Government' s suggestion that use could be made of the Court' s power to order interim measures. For it would be difficult to argue that the Court is the ideal forum in which to decide, as a matter of urgency, whether a particular product is safe. It seems to me that such questions are more appropriately dealt with, in the first instance, by the Committee on Product Safety Emergencies set up by Article 10 of the Directive. If it is considered that an opinion of the Committee is unjustified, it will of course always be possible to challenge the validity of the subsequent Commission decision.

47. Thus the German Government has in my opinion failed to demonstrate that the contested provision is disproportionate.

Conclusion

48. In my view, therefore, the German Government' s application is to be rejected. The German Government should accordingly be liable for the costs, in accordance with Article 69(2) of the Rules of Procedure. However, by Article 69(4) of those Rules, the Commission must, as intervener, bear its own costs.

49. I am accordingly of the opinion that the Court should:

(1) dismiss the application;

(2) order Germany to pay the costs of the Council; and

(3) order the Commission to bear its own costs.

(*) Original language: English.

(1) - OJ 1992 L 228, p. 24.

(2) - OJ 1987 L 197, p. 33.

(3) - See paragraph above.

(4) - See Pipkorn, in Groeben/Thiesing/Ehlermann Kommentar zum EWG-Vertrag (4th edition, Baden-Baden 1991), pp. 2867-2868; Ehlermann, The Internal Market following the Single European Act , Common Market Law Review 24 (1987) pp. 361-409, at pp. 398-399.

(5) - Council Directive 74/63/EEC of 17 December 1973 on the fixing of maximum permitted levels for undesirable substances and products in feedingstuffs (OJ 1974 L 38, p. 31), adopted under Articles 43 and 100 of the Treaty.

(6) - Case 5/77 [1977] ECR 1555.

(7) - See paragraphs 35 to 38 of the judgment.

(8) - See Article 100a(3), cited above in paragraph .

(9) - See, e.g., Article 5 of Council Directive 88/344/EEC of 13 June 1988 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (OJ 1988 L 157, p. 28); Article 7 of Council Directive 88/378/EEC of 3 May 1988 on the approximation of the laws of the Member States concerning the safety of toys (OJ 1988 L 187, p. 1); Article 21 of Council Directive 89/106/EEC of 21 December 1988 on the approximation of laws, regulations and administrative provisions of the Member States relating to construction products (OJ 1989 L 40, p. 12); Article 12 of Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (OJ 1989 L 186, p. 27); Article 16 of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (OJ 1990 L 117, p. 15).

(10) - See Ehlermann, cited above in note , at p. 398. An example is provided by Article 5 of Directive 88/344, cited above in note . Thus provisional measures can be taken under Article 5(1) and examined by the Commission under Article 5(2); the measures can then be incorporated into amendments of the directive under Article 5(3).

(11) - See Article 21 of Directive 89/106, and Article 7 of Directive 88/378, both cited in note .

(12) - Compare Articles 4 and 5(1) of Directive 88/378 and Articles 4(2) and 6(1) of Directive 89/106, cited above in note .

(13) - See Case 16/88 Commission v Council [1989] ECR 3457, paragraph 11 of the judgment.

(14) - See Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production (OJ 1988 L 184, p. 61), Article 4.

(15) - See Articles 2 and 3 of Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption (OJ 1989 L 40, p. 27); Article 2 of Directive 88/344, cited above in note .

(16) - See Article 4 of Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (OJ 1976 L 262, p. 169), adopted under Article 100 of the Treaty.

(17) - See for example Articles 8(2) and 12(3) of Directive 76/768, cited in note 16, and see the Twelfth Commission Directive 90/121/EEC of 20 February 1990 adapting to technical progress Annexes II, III, IV, V and VI to Council Directive 76/768/EEC (OJ 1990 L 71, p. 40), which was considered by the Court in Case C-212/91 Angelopharm, judgment given on 25 January 1994.

(18) - As in the case of Directive 88/344, cited above in note (see Article 5). In the case of Directive 76/768, cited in note , there is both a general power to adapt the directive to technical progress (Article 8(2)) and a power to do so in the light of safeguard measures taken by a Member State (Article 12(3)).

(19) - See Case 16/88 Commission v Council, cited above in note .