C-94/81
ECLI:EU:C:1982:74
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JUDGMENT OF THE COURT 2 MARCH 1982'
Commission of the European Communities v Italian Republic
(Failure of a State to fulfil its obligations — Cosmetic products)
Case 94/81
Member States — Obligations — Implementation of directives — Failure to comply — Justification — Not possible (EEC Treaty, Art. 169)
A Member State may not plead to comply wich obligations under provisions, practices or circumstances in Community directives. its internal legal system to justify failure
In Case 94/81 COMMISSION OF THE EUROPEAN COMMUNITIES, represented by G. Marenco, a member of its Legal Department, acting as Agent, with an address for service in Luxembourg at the office of O. Montako, a member of its Legal Department, Jean Monnet Building, Kirchberg, applicant, v ITALIAN REPUBLIC, in the person of its Agent, A. Squillante, Head of the Department for Contentious Diplomatic Legal Affairs, Treaties and Legislative Matters, represented and assisted by G. Fienga, Avvocato dello Stato, with an address for service in Luxembourg at the Italian Embassy, defendant, I — Language of the Case: Italian.
JUDGMENT OF 2. 3. 1982 - CASE »4/81
APPLICATION for a declaration that by not implementing Council Directive 76/768/EEC of 27 July 1976 on the a p p r o b a t i o n of the laws of the Member States relating to cosmetic products (Official Journal, 1976, L 262, p. 169) the Italian Republic has failed to fulfil its obligations under the EEC Treaty,
T H E COURT,
composed of: J. Menens de Wilmars President, G. Bosco and O. Due (Presidents of Chambers), A. O'Keeffe, T. Koopmans, A. Chloros and F. Grévisse, Judges,
Advocate General: P. VerLoren van Themaat Registrar: P. Heim
gives the following
JUDGMENT
Facts and Issues
The facts of the case, the course of products (Official Journal, L 262, the procedure and the conclusions, p. 169). submissions and arguments of the parties may be summarized as follows: 2. According to the directive, the Member States must ensure that cosmetic products are put on the market only if they conform to the provisions of the directive (Article 3) and they may not, I — Facts and procedure for reasons related to the requirements laid down in the directive, impede the marketing of products which comply 1. In this action the Commission is with the requirements of the directive asking the Court to declare that the (Article 7). The Member States must Italian Republic has failed to implement therefore prohibit the marketing of within the prescribed period Council cosmetic products containing the sub- Directive 76/768/EEC of 27 July 1976 stances listed in Annex II to the directive on the approximation of the laws of the (Article 4). Article 11 of the directive Member States relating to cosmetic provides for the establishment, at a
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second stage, by the Council, acting on a 1980 recalling the varying fortunes with proposal from the Commission, of lisu which the draft Law had met during the of permitted substances, the others life of the previous legislature and remaining prohibited. pointing out that it had been re- submitted to the Parliament and again approved by the Senate. After trans- 3. The directive provides (Article 14) mission to the Chamber of Deputies, it that within 18 months of its notification had been entrusted to the Health the Member States are to bring into Committee acting under, its legislative force the provisions needed in order to powers, so that its final approval might complv with it. That period expired on be expected very shonly. 30 January 1978.
5. The present application was lodged 4. By a letter dated 5 July 1979 at the Court Registry on 24 April 1981. addressed to the Ministry of Foreign Affairs of the Italian Republic, the The Italian Government has not lodged Commission, after noting that the period a rejoinder. for implementig the directive had expired and that it had received no communi- cation concerning the adoption of Upon hearing the repon of the Judge- implementing measures by the Italian Rapporteur and the views of the Republic, expressed the opinion that the ' Advocate General the Court decided to Italian Republic had failed to fulfil its open the oral procedure without any obligations and, in pursuance of Article preparator}' inquiry. 169 of the Treaty, it invited the Italian Government to submit its observations within a period of two months. II — C o n c l u s i o n s of the p a r t i e s The Italian authorities replied by a letter dated 11 July 1979, in which they A. In its application the Commission referred to an Italian note dated 12 April claims that the Court should: 1979 which had brought to the Commission's attention the fact that a draft law, submitted by the Italian (1) Declare that by omitting to adopt Government and already examined by within the prescribed period the the Senate, had lapsed because of the provisions needed to complv with premature dissolution of the Parliament. Directive 76/768/EEC of the The assurance was given that, once the Council of 27 July 1976 on the new government was constituted, it approximation of the laws of the would not fail to re-submit the draft Law Member States relating to to the Parliament. cosmetic products, the Italian Republic has failed to fulfil its obligations under the EEC On 19 May 1980 the Commission issued Treaty; a reasoned opinion in pursuance of Article 169 of the Treaty, and invited the Italian Government to comply with that (2) Order the defendant to pay the opinion within a period of two months. costs.
The response of the Italian authorities B. The ¡talian Government has not was contained in a letter dated 28 July presented any formal conclusions.
JUDGMENT OF 2. 3. 1982 — CASE 94/81
III — S u b m i s s i o n s and argu- Thus, quite apart from their extremely m e n t s of the p a r t i e s narrow scope, the measures in question do not even constitute, according to the Commission, an appropriate im- A — General observations plementation of the directive to which they refer. The directive requires for its implementation the creation of a legal 1. The Italian Government refers to the framework within which the rights and observations which it submitted prior to duties of traders are stipulated in a the Commission's application to the manner consistent with the requirements Court and contends in addition that, of clarity and certainty. within the limits permitted by the legislative provisions in force, it has taken care to adopt, at the administrative level, its own measures of surveillance B — Observations on the measures which are applied in the cosmetics sector adopted by Italy for the purpose of by the Ministry of Health, to the implementing the directive principles underlying the Community directive. 1. The Italian Government points out that where irregularities have been found Whilst admitting that the subject-matter to exist the manufacturers and distribu- of the dispute can only be eliminated by tors have been given formal notice to the adoption of a law implementing the make the packaging of their products directive, the Italian Government hopes comply with the provisions of the that the Court will as far as possible take directive. into account its administrative action. The Commission replies that it appears, although it is not certain, that the 2. The Commission observes that the measure adopted by the Italian provisions adopted by the Italian Government refers to Article 6 of the Government are incomplete and, even as directive. regards those points which they do cover, they do not appear to correspond faithfully to the requirements of the 2. The Italian Government also remarks directive. The aim of the directive, which that the elimination of dangerous or is to bring about complete harmonization pharmacologically active substances con- and, as a result, the elimination of tained in cosmetic products and listed in barriers to trade, is not achieved. The Annex II to the directive has been Commission also remarks that, leaving enforced by recourse to the procedures aside the incomplete nature of the of seizure or warning. provisions, as the Court stated in its judgment of 6 May 1980 in Case 102/79 According to the Commission, this Commission v Belgium [1980] ECR 1473, measure relates to the duty laid upon the Member States by Anicie 4 (a) of the "Mere administrative practices, which by directive. However, it is not clear their nature can be changed as and when whether the measure covers all or only the authorities please and which are not some of the 361 substances listed in publicized widely enough, cannot . . . be Annex II to the directive. regarded as a proper fulfilment of the obligation imposed by Article 189 on Member States to which the directives 3. The Italian Government stresses that are addressed". a ministerial order was expressly adopted
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on 6 June 1980 in order to prohibit the distributors concerned have frequently use in cosmetic products of placenta, been called upon to prove, by way of oestrogens und progestogens. appropriate documents, statements relating to the specific effects of their In the Commission 's view, this is again products within the confines, however, a measure which concerns Annex II, of the types of hygienic and cosmetic in particular point 194 concerning pro- therapy for which the products provide. gestogens and point 260 concerning oestrogens, whilst placenta is not The Commission replies that this mentioned in the directive. provision may refer to Anicie 6 (2) of the directive. 4. According to the Italian Government another ministerial order of 15 February· 6. The Italian Government adds that 1980 set limits to the use and to the Ministry of Health Circular No 60 of 11 content, in cosmetic products, of boric August 1980 draws the attention of all acid and its salts and derivatives, in traders in this sector to the necessity for conformity with the provisions contained scrupulous compliance with the rules in Pan I of Annex III to the directive. governing cosmetic products in order, inter alia, to maintain an absolutely clear In the Commission's opinion, the Italian distinction between cosmetics and Government is referring to the duty laid medicaments. upon the Member States by Anicie 4 (b) of the directive. Pan I of Annex III lists 29 substances, of which only that mentioned under Reference No 1 is IV — O r a l p r o c e d u r e covered by the ministerial order. Further, the directive mentions "boric acid", At the sitting on 2 December 1981, the whereas the ministerial order also covers Government of the Italian Republic, its salts and derivatives. As the latter represented by G. Fienga, Avvocato dello substances are not prohibited by the Stato, and the Commission, represented directive the Member States may not by G. Marenco, a member of its Legal prohibit them. Depanment, presented oral argument. The Advocate General delivered his 5. The Italian Government observes, opinion at the sitting on 3 Februarv lastly, that the manufacturers and 1982.
Decision
1 By application lodged at the C o u r t Registry on 24 April 1981 the Commission of the European Communities brought an action pursuant to Article 169 of the E E C T r e a t y for a declaration that by not adopting within the prescribed period the provisions needed to comply with Council Directive
JUDGMENT OF 2. 3. 1982 — CASE 94/81
76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (Official Journal 1976, L 262, p. 169), the Italian Republic has failed to fulfil its obligations under the Treaty.
: By virtue of Anicie 14 of the directive the Member States were to bring into force the provisions needed to comply with the directive within 18 months of its notification. In this case that period expired on 30 January 1978.
The Italian Government has stated that the directive has already been the subject of measures which implement it in part. Nevertheless it does not deny that the Italian Republic has not fulfilled its obligation to implement the directive fully within the prescribed period.
J In sum, the Italian Government justifies its omission by the need to have recourse to the legislative procedure for the purpose of implementing the directive. It prepared an appropriate draft Law which, after being approved by the Cabinet on 22 December 1977, was laid before the Parliament and approved, in turn, by the Health Committee of the Senate which transmitted it to the Chamber of Deputies for final approval. In the meantime, however, the premature dissolution of Parliament caused the draft Law to lapse. The Italian Government therefore immediately re-submitted the same draft Law to the new legislature. The draft was approved by the Health Committee of the Senate on 14 May 1980 and transmitted for approval to the 14th Standing Health Committee of the Chamber of Deputies where it is now undergoing final examination.
5 Those circumstances do not expunge the failure of the Italian Republic to fulfil its obligations, of which the Commission complains. According to established case-law of the Court a Member State may not plead provisions, practices or circumstances in its internal legal system to justify a failure to comply with obligations under Community directives.
» It must therefore be recorded that by not adopting within the prescribed period the provisions needed to comply with Council Directive 76/768/EEC
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of 27 July 1976 the Italian Republic has failed to fulfil its obligations under the Treaty.
Costs
7 Anicie 69 (2) of the Rules of Procedure provides that the unsuccessful party is to be ordered to pay the costs. Since the defendant has been unsuccessful, it must be ordered to pay the costs.
On those grounds,
THE COURT
hereby:
1. Declares that by not adopting within the prescribed period the provisions needed to comply with Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products, the Italian Republic has failed to fulfil its obligations under the Treaty;
2. Orders the Italian Republic to pay the costs.
Menens de Wilmars Bosco Due
O'Keeffe Koopmans Chloros Grévisse
Delivered in open court in Luxembourg on 2 March 1982.
P. Heim J. Menens de Wilmars Registrar Presidem