CELEX: 62001CC0420
Language: en
Date: 2003-02-27
Title: Opinion of Mr Advocate General Mischo delivered on 27 February 2003. # Commission of the European Communities v Italian Republic. # Failure to fulfil obligations - Free movement of goods - Articles28EC and 30 EC - Prohibition on the marketing of energy drinks containing caffeine in excess of a certain limit - Public health - Retention of a national provision incompatible with Community law. # Case C-420/01.

OPINION OF ADVOCATE GENERALMISCHO delivered on 27 February 2003 (1)
         Case C-420/01 Commission of the European CommunitiesvItalian Republic
            ((Failure to fulfil obligations – Free movement of goods – Articles 28 EC and 30 EC – Prohibition on the marketing of energy drinks containing caffeine in excess of a certain limit – Public health – Retention of a national provision incompatible with Community law))
            
      
         
      1.  The Commission of the European Communities seeks a declaration from the Court that, by applying to drinks manufactured and
      marketed in other Member States rules prohibiting the marketing in Italy of energy drinks containing caffeine in excess of
      a certain limit, without showing how such a limit is necessary and proportionate for the protection of public health, the
      Italian Republic has failed to fulfil its obligations under Articles 28 EC and 30 EC.
       I ─ Legal background
      
      
      
      A ─
       Community legislation
      
      2.  There is no Community legislation which lays down the conditions governing the addition of nutrients to common foodstuffs.
      
      
      
      B ─
       National legislation
      
      3.  Article 15(3) of Presidential Decree No 719 of 18 May 1958 (GURI No 178 of 24 July 1958, p. 3081, hereinafter  
      PD No 719/58), entitled  
      Regulation laying down the general health provisions relating to the production and marketing of sparkling water, and sparkling
      or still non-alcoholic drinks produced in sealed containers, provides:The addition of substances other than those listed in this regulation, which have not received prior approval by the High
      Commissioner for Hygiene and Public Health, must, at the request of the health authority of the district in which the factory
      is established and following an opinion from the district health council, be duly authorised in each case by the High Commissioner.
       II ─ Facts and pre-litigation procedure
      
      4.  The Commission's attention was drawn to the existence of barriers to the import into and marketing in Italy of certain energy
      drinks lawfully produced and marketed in other Member States. These drinks, including the Red Bull, CULT and GUVI brands,
      are characterised by the fact that they contain caffeine in quantities which vary from 250 mg/l to 320 mg/l and often contain
      other substances such as taurine.
      
      5.  On the basis of Legislative Decree No 111 of 27 January 1992 and in accordance with the opinion of 13 December 1995 of the
      Consiglio Superiore della Sanità (the Board of Health, the  
      CSS), the Italian authorities initially prohibited the marketing of these drinks, in particular those containing taurine.
      
      6.  However, the Italian authorities subsequently altered their position and authorised the marketing in Italy of such drinks
      on condition that the caffeine content did not exceed 125 mg/l.
      
      7.  On the basis that this limit represented a measure having equivalent effect to a quantitative restriction on imports, contrary
      to Article 28 EC and not justified by Article 30 EC in the absence of scientific data demonstrating the extent to which exceeding
      that limit would be harmful to public health, the Commission addressed a letter of formal notice, dated 4 October 1996, to
      the Italian Government.
      
      8.  By letter of 8 January 1997 the Italian authorities responded, observing that following the decisions of the Minister for
      Health of 13 December 1995, there was no longer any barrier to the marketing in Italy of drinks of the type in question which
      were lawfully marketed in other Member States, provided that the caffeine content did not exceed 125 mg/l, a limit soon to
      be raised to 150 mg/l, in accordance with the Italian legislation in force, in particular PD No 719/58.
      
      9.  The Commission considered this response to be unsatisfactory and addressed a reasoned opinion to the Italian authorities on
      23 September 1997.
      
      10.  By letter of 11 December 1997, the Italian authorities stated that the Minister for Health had requested a new opinion from
      the CSS and asked that the Commission provisionally suspend the infringement procedure in order to await the reply of the
      CSS.
      
      11.  By letter of 6 March 1998, the Italian authorities informed the Commission that the CSS had determined that, according to
      current levels of knowledge, the drinks in question raised no public health concerns and that a circular (a copy of which
      was enclosed) had authorised that they be placed on the market for consumption and provided for the communication of certain
      information to the consumer by means of a label containing instructions and warnings.
      
      12.  By letter of 2 April 1998, the Commission replied, amongst other things, that while a circular is an appropriate means of
      guaranteeing immediate compliance with Community provisions on free movement of goods, the Italian authorities nevertheless
      remained under the obligation to amend the legislation in question as soon as possible definitively and by the usual procedure.
      
      13.  By letter of 18 June 1998, the Minister for Health notified the Commission of the publication of Circular No 5 of 3 April
      1998 (GURI No 101, General series, 4 May 1998, p.72), entitled  
      Drinks of Community origin characterised by high levels of caffeine and taurine, stating that the observations of the Commission had been taken into account in the application of the circular.
      
      14.  In the meantime, the Commission had contacted the complainants, who confirmed that, in practice, the free movement in Italy
      of drinks originating in other Member States was being ensured as a result of Circular No 5 of 3 April 1998.
      
      15.  However, by fax of 14 April 1999, the Commission reminded the Italian authorities of their undertaking to adopt an appropriate
      measure, in the form of a legislative amendment, to govern the matter.
      
      16.  The Italian authorities forwarded to the Commission a draft regulation drawn up by the Minister for Industry, Trade and Crafts
      relating to  
      rules for the manufacturing and marketing of bottled water and non-alcoholic drinks.
      
      17.  While the Commission was of the opinion that the draft regulation called for a number of observations regarding the scope
      of the mutual recognition clause, it noted, by letter of 22 November 1999, that the proposal, once adopted, would result in
      the infringement procedure being closed. 
      
      18.  Following further reminders by the Commission to the Italian authorities as to the need for a legislative amendment of the
      provision in question, the authorities notified the Commission, on 13 November 2000, of a draft regulation containing the
      text of PD No 719/58 in an annex; this proposal was intended to update the legislation on the production and sale of non-alcoholic
      drinks generally, including those containing caffeine, and included in Article 9 a mutual recognition clause excluding from
      its scope non-alcoholic drinks lawfully produced and marketed in other Member States or in countries signatories to the European
      Economic Area Agreement.
      
      19.  The Commission reminded the Italian authorities of the observation it had made in its letter of 22 November 1999, that the
      mutual recognition clause needed to be altered in some respects in order to eliminate all ambiguity. Having received no response
      from the Italian Republic, the Commission, by letter of 9 April 2001 and referring back to its letter of 22 November 1999,
      asked the Italian authorities whether they had received the observations on the draft and when the Italian Government expected
      to adopt the regulation.
      
      20.  Given that the original text of PD No 719/58 was still in force and that no amendment had been made in order to bring the
      matter of recognition of non-alcoholic drinks produced and marketed in other Member States into line with Community law, the
      Commission brought the present proceedings.
       III ─ Forms of order sought
      
      21.  In its application, lodged at the Court Registry on 23 October 2001, the Commission claims that the Court should:
      
      
      ─
         declare that, by applying to drinks produced and marketed in other Member States a rule prohibiting the marketing in Italy
         of energy drinks containing caffeine in excess of a certain limit, without showing that that limit is necessary and proportionate
         for the protection of public health, the Italian Republic has failed to fulfil its obligations under Articles 28 EC and 30 EC;
         and 
      
      
      
      ─
         order the Italian Republic to pay the costs. 
      
      
      
      22.  The Italian Republic contends that the Court should dismiss the case as unfounded.
       IV ─ Analysis
      
      
      
      A ─
       Arguments of the parties
      
      23.  The Commission asserts that, while it may not be possible to identify clearly the legal basis for the prohibition on importing
      into and marketing in Italy non-alcoholic drinks with a caffeine content in excess of 125 mg/l, it is indisputable that such
      a prohibition exists. That is confirmed by the complaints addressed to the Commission by a number of Community manufacturers
      of non-alcoholic energy drinks, by the wording of Article 15(3) of PD No 719/58, and by the fact that the Italian authorities
      have (as evidenced by the adoption of Circular No 5 of 3 April 1998 and the draft regulation notified to the Commission) themselves
      recognised the necessity, if not the obligation, to amend and/or repeal certain provisions of the legislation currently in
      force in the non-alcoholic drinks sector.
      
      24.  The Commission considers that in view of the case-law of the Court in relation to Articles 28 EC and 30 EC, and in particular
      the judgment in  
       Commission  v  
       Germany , known as the  
       Beer Purity Law  judgment, 
      
         			(2)
         		 the merits of the case are not in dispute.
      
      25.  As regards a possible justification based on the protection of human health and life, the Commission argues that in any event
      it is difficult to see how the Italian authorities can assert on the one hand that drinks with a high caffeine content pose
      a risk to health and, on the other hand, authorise their distribution, as the Italian Republic did by means of Circular No
      5 of 3 April 1998.
      
      26.  The Commission also draws attention to the fact that the CSS opinion of 13 December 1995, to which the Italian authorities
      refer, has been superseded, the CSS itself having rendered a subsequent opinion which states that the drinks in question pose
      no health risks. The Commission contends that this latter opinion is, moreover, confirmed by the opinion issued by the Scientific
      Committee for Food on 21 January 1999.
      
      27.  It is the opinion of the Commission that the disputed issue relates rather to the measure adopted by the Italian Republic
      in order to bring its legislation into line with the principles of Community law, once it had been found to be incompatible
      with Community law. Given that a Member State cannot discharge its obligations under a directive by means of a mere circular
      which can be amended by the administration at will, the Commission considers that in the light of the judgment in  
       Commission  v  
       Germany  
      
         			(3)
         		 Circular No 5 of 3 April 1998 is not sufficient to amend the contested provisions in Article 15 of PD No 719/58.
      
      28.  The Italian Government states in its defence that the fixing of an upper limit for caffeine content is justified in particular
      by the evaluations undertaken by the relevant health authorities. It contends that the whole matter must be resolved from
      the point of view of the lawfulness of the scientific position adopted by the Italian health authorities. Any other solution
      would, according to the Italian Government, deprive Article 30 EC of its content by replacing the non-arbitrary discretion
      of the Member State with the subjective opinion of the health authorities of another Member State, which although legitimate
      cannot, by its very nature, be considered as indisputable.
      
      29.  The Italian Government considers that it is for the Commission to produce scientific evidence that, given the prevailing environmental
      conditions in Italy, the fixing of a maximum authorised caffeine level, which is considered in the majority of cases not to
      be harmful to the consumer, does not satisfy the criteria of a proper balancing of the interests in question.
      
      30.  The Italian Government adds, however, that it still intends to formalise its position as regards the maximum acceptable level
      of caffeine in alcoholic drinks and the introduction of rules governing the composition of non-alcoholic drinks. However,
      it stresses that this intention is not the result of either a legal obligation or an absolute necessity inasmuch as technical
      rules, such as the one envisaged, inevitably reflect current scientific knowledge and take no account of any possible interaction
      with ingredients of specified alcoholic drinks, whether cited in the relevant provisions or not. Reserving the right to issue
      a specific authorisation for the use of ingredients other than those envisaged serves rather to evaluate that interaction
      and, as a result, to protect the life and health of consumers, which should not be subject to considerations relating to profit
      or to abstract interpretations of the EC Treaty.
      
      31.  The Italian Government also notes that the rule which applies to drinks imported from other Member States applies equally
      to drinks produced in Italy.
      
      32.  In its rejoinder, the Italian Government affirms once again that a legislative text amending the provisions which were considered
      not to have been brought into line with the approach taken by the health authorities of other Member States had been drawn
      up and was submitted in April 2002 for examination by the authority representing all relevant local bodies. Moreover, the
      Italian Government contends that Circular No 5 of 3 April 1998 permitted the marketing in Italy of products with a higher
      caffeine content than that authorised by the relevant rules in force in this sector.
      
      
      
      B ─
       Assessment
      
      33.  The documents in the file show that at the end of the period laid down in the reasoned opinion, which according to settled
      case-law 
      
         			(4)
         		 is the date at which the existence of a failure to fulfil obligations must be assessed and which in this case is the end
      of November 1997, 
      
         			(5)
         		 there existed a prohibition on the marketing in Italy of energy drinks lawfully for sale in other Member States but having
      a caffeine content in excess of 125 mg/l.
      
      34.  Despite the fact that, even after a written question on the matter put by the Court, some doubt remains as to the basis in
      national law for this prohibition (Article 15(3) of PD No 719/58 does not, in fact, contain any such prohibition), the Italian
      Government has never sought to deny the existence thereof as at the date mentioned above. On the contrary, it specifically
      recognised it in its response of 8 January 1997 to the letter of formal notice.
      
      35.  Nevertheless, even if the prohibition was simply in the form of an administrative practice it may still constitute a failure
      to fulfil obligations. 
      
         			(6)
         		
      36.  Given that this prohibition on marketing, in so far as it applies to imported products, constitutes a measure having equivalent
      effect to a quantitative restriction on imports contrary to Article 28 EC, the question arises as to whether this prohibition
      is justified by one of the interests laid down in Article 30 EC and in particular that of the protection of human health and
      life.
      
      37.  In this respect it is important to recall the settled case-law to the effect that it is for the competent national authorities
      to show, in each case, that their rules are necessary to properly protect the interests referred to in Article 30 EC and,
      in particular, that the marketing of the product in question poses a risk for public health. 
      
         			(7)
         		
      38.  However, I agree with the Commission that the Italian Government has not proved that the prohibition which was in force at
      the end of November 1997 was justified by a need to protect human life and health.
      
      39.  In fact, the only piece of evidence advanced by the Italian Government is the opinion rendered by the CSS on 13 December 1995.
      
      40.  However, independently of the fact that, as stated in the letter of the Italian authorities of 6 March 1998, the CSS itself
      subsequently overruled this opinion, a reading of that original opinion reveals that in any event it related to drinks containing
      a high level of caffeine  
       and  taurine as well as a caffeine content as high as 320 mg/l, more than double the limit of 125 mg/l.
      
      41.  It therefore cannot be concluded from that CSS opinion that a prohibition on the marketing in Italy of energy drinks lawfully
      sold in other Member States but having a caffeine content in excess of 125 mg/l was in fact necessary to protect human health
      and life.
      
      42.  In response to a written question by the Court, the Italian Government contended once again that the issue which formed the
      basis of the action for failure to fulfil obligations had been resolved by the adoption of Circular No 5 of 3 April 1998.
      
      43.  This fact does not, however, lead to the conclusion that the action for failure to fulfil obligations is unfounded. As already
      noted above, it is  
      settled case-law that the question whether a Member State has failed to fulfil its obligations must be determined by reference
      to the situation prevailing in the Member State at the end of the period laid down in the reasoned opinion, and that  
       the Court cannot take account of any subsequent changes   .... 
      
         			(8)
         		
      44.  On the other hand, it is not possible to agree with the argument presented by the Commission in its application, according
      to which the disputed issue relates principally to the measure adopted by the Italian State in order to bring its legislation
      into line with the principles of Community law after it was found to be incompatible with Community law, and therefore to
      the question of whether by adopting Circular No 5 of 3 April 1998 the Italian Government has remedied the incompatibility.
      
      45.  I am of the opinion that that question is not relevant to the case in hand.
      
      46.  It is appropriate in this respect to refer to the judgment in  
       Commission  v  
       Italy , 
      
         			(9)
         		 which dealt with facts similar to those in the present case.
      
      47.  In that case, the Commission had brought an action before the Court against the Italian Republic for failure to fulfil obligations
      as a result of a system of turnover tax which it considered constituted an infringement of Article 95 of the EEC Treaty (now,
      after amendment, Article 90 EC).
      
      48.  The Italian Republic, in its defence, observed that a Decree-Law which had amended the tax system in dispute was, in its opinion,
      of such a nature as to justify the withdrawal of the application. The Commission disagreed, and a debate ensued between the
      parties relating to the impact and effects of the tax system introduced by the Decree-Law in question to the point where they
      asked the Court to consider the resulting situation as a whole.
      
      49.  In response to this request, the Court declared, at paragraph 4 of the  judgment, that  
      ... in so doing the applicant has thus amended the subject-matter of its application so that it is no longer concerned only
      with the question whether at the time when the application was lodged there was a failure on the part of the Italian Republic
      to fulfil its obligations under Article 95, but principally with the question whether this failure still continues after the
      coming into force of the Decree-Law ....
      
      50.  The Court continued, at paragraphs 5 and 6 of that judgment, in the following terms: 
      
      5
         
       ... the Court cannot give judgment in the present case on the failure to fulfil an obligation occurring after legislation
      has been amended during the course of the proceedings without thereby adversely affecting the rights of the Member State to
      put forward its arguments in defence based on complaints formulated according to the procedure laid down by Article 169. 
      
      
      6
         
       In such circumstances  
       it is for the Commission to commence new proceedings under Article 169 with regard to the effects of Decree-Law No 319, and
         if necessary to refer to the Court the specific shortcoming upon which it desires the Court to pronounce   ...
      . 
      
         			(10)
         		
      51.  This judgment represents the precursor to what has since become settled case-law, to the effect that the application introduced
      under Article 226 EC must be based on the same grounds and pleas as the reasoned opinion. 
      
         			(11)
         		
      52.  However, in the case at hand, the allegation by the Commission that the Italian Republic has failed to fulfil its obligations
      under Articles 28 EC and 30 EC by lifting a prohibition on marketing which was contrary to the Treaty by means of the adoption
      of a circular amounts to a different ground of failure to that made against the same Member State for having failed to fulfil
      the same obligations by reason of the very existence of that prohibition.
      
      53.  The reasoned opinion is founded exclusively on that second ground of failure. The first ground is therefore inadmissible.
      
      54.  In any event, I wonder whether there is sufficient information available to the Court to permit a useful examination of that
      first ground of failure in the absence of any pre-litigation procedure, the proper conduct of which, according to the Court,
       
      constitutes an essential guarantee required by the Treaty not only in order to protect the rights of the Member State concerned,
      but also so as to ensure that any contentious procedure will have a clearly defined dispute as its subject-matter (see Case
      C-1/00  
       Commission  v  
       France  [2001] ECR I-9989, paragraph 53). 
      
         			(12)
         		
      55.  It is appropriate to recall the lack of clarity as regards the legislative basis in Italian law for the disputed prohibition.
      Whilst the Commission considered that Circular No 5 of 3 April 1998 is not sufficient to amend Article 15 of PD No 719/58,
      it recognised in its response to a written question put by the Court that the disputed prohibition may not result in fact
      from that provision, but simply from administrative practice.
      
      56.  However, this question of the legislative basis for the disputed prohibition seems to me to be of fundamental importance to
      the assessment of the manner in which the Italian Republic must remedy its failure which has, in my opinion, been established
      and is based on the existence of the prohibition at the end of the period laid down in the reasoned opinion.
      
      57.  While a Member State may not  
      repeal a domestic legislative provision giving rise to a failure to fulfil obligations by means of a circular, I cannot see prima
      facie, on the other hand,  why a Member State may not (other than in the context of the implementation of a directive, which
      is not the case here) convert by means of a circular an administrative practice which breaches the Treaty into a practice
      which conforms to the Treaty.
        V ─ Conclusion
      
      58.  In the light of the foregoing, I propose that the Court:
      
      
      ─
         declare that, by applying to drinks produced and marketed in other Member States rules prohibiting the marketing in Italy
         of energy drinks containing caffeine in excess of a certain limit, without showing how such a limit is necessary and proportionate
         for the protection of human health, the Italian Republic has failed to fulfil its obligations under Articles 28 EC and 30
         EC; 
      
      
      
      ─
         order the Italian Republic to pay the costs. 
      
      
      
       1 –
         
           Original language: French.
      
      2 –
         
         Case 178/84 [1987] ECR 1227.
      
      3 –
         
         Case C-96/95 [1997] ECR I-1653.
      
      4 –
         
         See  
             inter alia  Case C-133/94  
             Commission  v  
             Belgium  [1996] ECR I-2323, paragraph 17, and Case C-122/02  
             Commission  v  
             Belgium  [2003] ECR I-833, paragraph 11.
         
      
      5 –
         
         In this case the reasoned opinion laid down a period of two months from its communication to the Italian Government for the
            latter to adopt the measures necessary to comply with its obligations under Community law. The reasoned opinion was communicated
            to the Italian Government in a letter of 23 September 1997. The end of the period laid down by the reasoned opinion is therefore
            at the end of November 1997.
         
      
      6 –
         
         See, for example, Case 21/84  
             Commission  v  
             France  [1985] ECR 1355, paragraph 12; Case C-187/96  
             Commission  v  
             Greece  [1998] ECR I-1095, paragraph 23; and Case C-185/96  
             Commission  v  
             Greece  [1998] ECR I-6601, paragraph 35.
         
      
      7 –
         
         See, in particular, Case 304/84  
             Minstère public  v  
             Muller and Others  [1986] ECR 1511, paragraph 25; the  
             Beer Purity Law  judgment, cited above; Case C-42/90  
             Bellon  [1990] ECR I-4863, paragraph 16; and Joined Cases C-13/91 and C-113/91  
             Debus  [1992] ECR I-3617, paragraphs 17 and 18.
         
      
      8 –
         
         Case C-122/02  
             Commission  v  
             Belgium , cited above, paragraph 11.
         
      
      9 –
         
         Case 7/69 [1970] ECR 111.
      
      10 –
         
         Emphasis added.
      
      11 –
         
         See, in particular, Case C-347/88  
             Commission  v  
             Greece  [1990] ECR I-4747, paragraph 16; Case C-439/99  
             Commission  v  
             Italy  [2002] ECR I-305, paragraph 11; and Case C-287/00  
             Commission  v  
             Germany  [2002] ECR I-5811, paragraph 18.
         
      
      12 –
         
         Case C-287/00  
             Commission  v  
             Germany , cited above, paragraph 17.