CELEX: 61984CC0187
Language: en
Date: 1985-06-20
Title: Opinion of Mr Advocate General Darmon delivered on 20 June 1985. # Criminal proceedings against Giacomo Caldana. # Reference for a preliminary ruling: Pretura unificata di Torino - Italy. # Dangerous substances - Labelling. # Case 187/84.

OPINION OF MR ADVOCATE GENERAL
      DARMON
      delivered on 20 June 1985 (
            *1
         )
      
         Mr President,
      
      
         Members of the Court,
      
      
               1. 
            
            
               By order of 9 October 1984, the Pretore di Turino [Magistrates' Court, Turin] asks the Court to rule under Article 177 of the Treaty on the question:
               ‘Whether Directive 67/548/EEC, as amended by Directive 79/831/EEC, requires not only substances on their own but also substances in preparations to be labelled “in accordance with Articles 15 to 18 and with the criteria in Annex VI, and in accordance with the results of the tests provided for in Article 6”, save where “contrary requirements for dangerous preparations are specified in separate directives”.’
               Council Directive 67/548/EEC of 27 June 1967 (Official Journal, English Special Edition 1967, p. 234), which has already been amended six times, deals with the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances.
               The question is therefore whether the Community rules presently in force require labelling not merely of dangerous substances but also of preparations containing such substances.
            
         
               2. 
            
            
               The facts submitted to the national court are fairly simple. Fina Italiana SpA, whose legal representative is Mr Caldana, manufactures and distributes fuels and oils. In the course of an inspection, inspectors from the Italian Environmental Protection Service removed containers of mineral oil marketed by Fina Italiana for use in motor vehicles. Tests carried out on the oil showed that it contained polychlorinated byphenyls (hereinafter referred to as ‘PCB’) in percentages which did not exceed the legal maxima for the marketing of such products.
               However, Mr Caldana is charged with not having affixed to the containers labels indicating the presence of PCB in the oil, as required by the provisions of a decree of the Italian Minister of Health of 21 May 1981. Mr Caldana was charged under Article 10 of Italian Law No 256 of 29 May 1984, which provides as follows :
               ‘Any producer, importer or distributor who markets dangerous substances or preparations which do not comply with the provisions of this law is liable ... to a fine ...
               In more serious cases, offenders may be sentenced to a term of imprisonment of up to six months’.
            
         
               3. 
            
            
               The national court found that administrative and judicial practice in Italy vary in this matter.
               In circulars Nos 77 of 18 August 1978 and 23 of 19 April 1982, the Italian Minister of Health stated that the rules requiring labelling
               ‘are applicable only to the substances and special preparations expressly indicated in Annex I of the Ministerial Decree of17 December 1977 (subsequently replaced by the Ministerial Decree of 25 May 1981)’.
               Those decrees were adopted for the purpose of implementing Law No 256 of 29 May 1984 which was itself adopted in order to implement Directive 67/548/EEC.
               In contrast to that restrictive interpretation adopted by the administration, the criminal courts generally consider that the aforementioned rules apply not only to the substances and preparations expressly referred to in the legislation (Annex I of the Decree of 21 May 1981) but also to preparations containing such substances.
               In the Commission's view, the Italian laws and decrees applying to this matter constitute a correct implementation of the Community provisions. If that is the case, the reply that the Court should give will determine the outcome of the criminal proceedings in Italy.
            
         
               4. 
            
            
               Mr Caldana, the Commission and the Italian Government submitted observations which arrive at the same conclusion.
               Directive 67/548/EEC as amended only regulates the classification, packaging and labelling of dangerous substances marketed as such. It deals only exceptionally with preparations and only when a directive concerning a particular category of preparations — there are three at present — expressly refers to it. In the present state of Community legislation, labelling of packages is not mandatory for preparations other than those referred to in special directives.
               Mr Caldana and the Government of the Italian Republic consider that the rules concerning labelling of dangerous preparations merely indicate a general programme. The Commission, for its part, regards those rules as special rules. It considers that in the absence of a directive establishing a complete list of dangerous preparations, the Member States have a limited discretion with regard to the requirements of labelling. Any other attitude would be likely to give rise to differences between national legislations which would frustrate the harmonization which the Treaty seeks to achieve or to inconsistency caused by labelling short of, or going beyond, what is required to eliminate risks.
            
         
               5. 
            
            
               The Community rules were very extensively set out by the Commission. Let me refer to its observations for the purpose of providing an outline of those rules.
               
                        (1)
                     
                     
                        The marketing and use of certain dangerous substances and preparations are governed by Council Directive 76/769/EEC of 27 July 1976 (Official Journal L 262 of 27 September 1976, p. 201) on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing use of certain dangerous substances and preparations. It has been amended three times, most recently by Directive 82/828/EEC of 3 December 1982 (Official Journal L 350 of 10 December 1982, p. 34). The annex to that directive sets out a list of dangerous substances and preparations and lays down the conditions under which they may be marketed and used. According to that annex (first column, paragraph 1, third indent), preparations containing polychlorinated biphenyls may only be marketed if they contain no more than 0.1% by weight of those products or, if that percentage is exceeded, under the exceptional and restrictive conditions laid down in that part of the annex entitled ‘Conditions of restriction’.
                     
                  
                        (2)
                     
                     
                        The requirements regarding classification, packaging and labelling are governed by another series of directives which deal with the method rather than the conditions for marketing dangerous substances.
                        Council Directive 67/548/EEC was almost entirely restructured by Directive 79/831/EEC of 18 September 1979 (Official Journal L 259 of 15 October 1979, p. 10). I will refer later to the articles of this directive which are relevant to the present case. Its title refers only to the classification, packaging and labelling of dangerous substances.
                        
                        Directive 79/831/EEC also contains nine annexes. The first of these establishes a list of dangerous substances and the sixth establishes general classification and labelling requirements for such substances. The other annexes lay down requirements of a technical and methodological nature.
                        Articles 20 and 21 of Directive 79/831/EEC provide for a committee to adapt to technical progress the directives concerning the elimination of technical barriers to trade in dangerous substances and preparations and lays down a special procedure permitting the Commission to adopt adaptation measures.
                        With regard to preparations, the third recital in the preamble to Council Directive 73/173/EEC of 4 June 1973 on the approximation of Member States' laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous preparations (solvents), indicates very clearly that the matter can only be resolved progressively by category of preparation, ‘in view of the extent of this field and the many detailed measures which will be required for the approximation of all the provisions relating to dangerous preparations... ’.
                        At present, according to information supplied by the Commission which has not been contested, there are three special directives dealing with certain preparations regarded as dangerous: solvents (Council Directive 73/173/EEC, Official Journal L 189 of 11 July 1973, p. 7), paints, varnish, printing inks, adhesives and similar products (Council Directive 77/728/EEC of 7 November 1977, Official Journal L 303 of 28 November 1977, p. 23), and pesticides (Council Directive 78/631/EEC of 26 June 1978, Official Journal L 206 of 29 July 1978, p. 13).
                     
                  
                        (3)
                     
                     
                        The Commission also indicated that a directive is presently being prepared on dangerous preparations. It will likewise be a general directive, similar in scope to the one dealing with dangerous substances, and is intended to replace the abovementioned three directives dealing with certain preparations as well as covering other preparations which have not heretofore been regulated.
                     
                  
         
               6. 
            
            
               Mineral oils are undoubtedly preparations within the meaning of Article 2 (1) (b) of Directive 67/548/EEC, as amended by Directive 79/831/EEC (Art. 1), inasmuch as they are ‘mixtures or solutions composed of two or more substances’. It is not disputed that their polychlorinated biphenyl content does not exceed 0.1% and that consequently, in accordance with the provisions of the annex to Council Directive 76/769/EEC, they may be marketed. It remains to be determined by which method they may be marketed: in other words, whether the polychlorinated biphenyls which they contain must be mentioned on the labels affixed to the containers in which they are marketed.
               Even if the oils could be regarded as dangerous preparations, it does not appear that such preparations come within the scope of Directive 67/548/EEC as amended, for the following reasons:
               
                        (a)
                     
                     
                        The title of that directive refers only to the ‘classification, packaging and labelling of dangerous substances’. According to the fourth recital in the preamble to the 1967 text,
                        ‘in view of the preparatory work still to be carried out, the approximation of provisions relating to dangerous preparations will have to be dealt with in later directives; ...therefore the present directive must be restricted to the approximation of provisions relating to dangerous substances’.
                        Only the last recital in the preamble to Directive 79/831/EEC refers to toxic, harmful, corrosive or irritating substances and preparations, but it deals only with their classification by the use of general definitions.
                     
                  
                        (b)
                     
                     
                        Article 1 (1) of Directive 67/548/EEC, as amended, which defines the scope of the directive, refers only to substances. It is couched in the following terms:
                        
                                 ‘(1)
                              
                              
                                 The purpose of this directive is to approximate the laws, regulations and administrative provisions of the Member States on:
                                 
                                          (a)
                                       
                                       
                                          the notification of substances, and
                                       
                                    
                                          (b)
                                       
                                       
                                          the classification, packaging and labelling of substances dangerous to man and the environment,
                                       
                                    which are placed on the market in the Member States.’
                              
                           The three remaining paragraphs of Article 1 refer only to substances. The scope of Directive 67/548/EEC as amended appears therefore to be limited to substances.
                     
                  
                        (c)
                     
                     
                        According to Article 4 (2)
                        ‘The dangerous substances listed in Annex I shall, where appropriate, be given a rating enabling the health hazard of preparations to be assessed. The ratings shall be determined in accordance with the criteria established by a subsequent Council directive.’
                        That provision mentions the existence of preparations containing dangerous substances but expressly provides that the criteria for assessing the hazard that they might present are to be established by a subsequent directive. In principle, therefore, that provision excludes dangerous preparations from the scope of the directive which the Court is asked to interpret.
                     
                  
         
               7. 
            
            
               However, as the national court pointed out, certain articles of the directive in question refer to substances and preparations.
               
               Article 2 (1) (b) defines preparations. Article 2 (2) defines what is meant by ‘dangerous’ in regard to substances and preparations.
               
               Article 3 provides that:
               ‘The general principles of the classification and labelling of substances and preparations shall be applied according to the criteria in Annex VI, save where contrary requirements for dangerous preparations are specified in separate Directives’ (the italics are mine).
               Finally, Article 5 (1) of Directive 67/548/EEC, as amended, provides that
               
                        ‘(1)
                     
                     
                        The Member States shall take all the measures necessary to ensure that without prejudice to Article 8 substances cannot be placed on the market on their own or in preparations unless the substances have been:
                        
                                 —
                              
                              
                                 notified to the competent authority of one of the Member States in accordance with this directive,
                              
                           
                                 —
                              
                              
                                 
                                    packaged and labelled in accordance with Articles 15 to 18 and with the criteria in Annex VI, and in accordance with the results of the tests provided for in Article 6’ (the italics are mine).
                              
                           
                  For the reasons set out above, it appears that those provisions do not extend the scope of the directive to preparations generally.
               
                        (a)
                     
                     
                        Article 5 (1), to which the national court specifically refers, can only concern new substances not yet marketed when the directive entered into force.
                        Besides the mention of marketing contained in the text itself, reference must also be made to the third recital in the preamble to Directive 79/831, which expressly refers to ‘new substances’ and the notification which must be given to the competent authorities that they are to be placed on the market.
                        By virtue of Article 1 (4) (a) of Directive 67/548/EEC as amended, Articles 5, 6 and 7 of the directive do not apply to substances listed in an inventory of substances on the Community market drawn up by the Commission under Article 13. That inventory was drawn up on 18 September 1981. Polychlorinated biphenyls, already mentioned in Council Directive 76/769/EEC (see sixth, seventh and eighth recitals of the preamble) cannot be regarded as new substances. Consequently, the provisions laid down in Article 5 (1) are not applicable to them.
                     
                  
                        (b)
                     
                     
                        Article 2 (1) merely makes it possible to distinguish substances from preparations. As I have already said, Article 4 (2) deals with the criteria for assessing the hazard presented by preparations containing dangerous substances, and, moreover, is merely in the nature of a general ‘programme’.
                     
                  
                        (c)
                     
                     
                        All that remains to be considered is Article 3 (3). That provision lays down general criteria for the classification and labelling of substances and preparations by referring to the criteria in Annex VI of the directive ‘save where contrary requirements for dangerous preparations are specified in separate directives’.
                        Part II (B) defining corrosion and irritation criteria and Part II (D) containing the ‘guide for the labelling of dangerous substances’ (the italics are mine) of Annex VI (the title of which refers solely to substances) were extensively revised by Commission Directive 83/467/EEC (Official Journal L 257 of 15 September 1983).
                        However, as the national court noted, Parts II (B) and II (D) lay down general criteria for the classification and labelling of both substances and preparations.
                        It should also be noted that Points 5.2 (a) and (c) of Part II (D) (Annex III of Directive 83/467/EEC) expressly refer to separate directives dealing with preparations.
                        However, as the Commission has clearly shown, there is a connection between Directive 67/548/EEC as amended and the three special directives which repeat many provisions contained in the former.
                        Having regard to the fact that the scope of Directive 67/548/EEC is restricted in regard to labelling to dangerous substances, it must be concluded that the rules laid down in Annex VI concerning the labelling of dangerous preparations will only be binding when a separate directive is adopted implementing the general provisions laid down in the general directive on substances.
                        If any doubt remains on the subject, it will be dispelled by recalling that a general directive is being prepared on the classification, packaging and labelling of preparations, which would only be justified if that area was not already regulated.
                     
                  
                        (d)
                     
                     
                        Finally, above and beyond the legal arguments, the Commission advanced a number of pertinent technical arguments. The most important appears to be that the physical and chemical properties of a dangerous substance and those of a preparation containing that substance are not necessarily the same since such a substance may no longer be dangerous when incorporated into a preparation. If the labelling measures laid down in Articles 15 to 18 of Directive 67/548/EEC as amended were applied to all preparations containing dangerous substances in spite of the fact that the criteria referred to in Article 4 (2) have not yet been laid down, it would be necessary to mention the presence of infinitely tiny impurities, which would give rise to results both absurd and contrary to the objective to be attained.
                     
                  
         
               8. 
            
            
               The Commission also addressed itself to the question of the freedom which the Member States, the manufacturer or the importer might have in labelling on their own initiative packages containing preparations which might be dangerous. I will not deal with that question since, on the one hand, it appears from the file that the Italian legislation contains no provision of that type and on the other, the national court did not ask the Court of Justice to rule on that point.
            
         
               9. 
            
            
               Consequently, I propose that the Court reply to the Pretore di Torino as follows :
               Directive 67/548/EEC, as amended by Directive 79/831/EEC, does not impose mandatory labelling conditions in respect of preparations containing one or more dangerous substances unless those preparations come within the scope of Directives 73/173/EEC, 77/728/EEC and 78/631/EEC on the classification, packaging and labelling of certain categories of preparations.
            
         (
            *1
         )	Translated from the French.