1 BY AN ORDER OF 9 JULY 1984 , RECEIVED AT THE COURT ON 13 JULY 1984 , THE PRETORE DI TORINO ( MAGISTRATES ' COURT , TURIN ), REFERRED TO THE COURT FOR A PRELIMINARY RULING UNDER ARTICLE 177 OF THE EEC TREATY A QUESTION ON THE INTERPRETATION OF CERTAIN PROVISIONS OF COUNCIL DIRECTIVE 67/548/EEC OF 27 JUNE 1967 ON THE APPROXIMATION OF LAWS , REGULATIONS AND ADMINISTRATIVE PROVISIONS RELATING TO THE CLASSIFICATION , PACKAGING AND LABELLING OF DANGEROUS SUBSTANCES , AS AMENDED BY COUNCIL DIRECTIVE 79/831/EEC OF 18 SEPTEMBER 1979 .
2 THE QUESTION AROSE IN CRIMINAL PROCEEDINGS BROUGHT AGAINST MR CALDANA , THE LEGAL REPRESENTATIVE OF FINA ITALIANA SPA , AFTER INSPECTORS OF THE ITALIAN ENVIRONMENTAL PROTECTION SERVICE HAD DISCOVERED THAT MINERAL OILS FOR USE IN MOTOR VEHICLES OFFERED FOR SALE BY THE COMPANY IN QUESTION CONTAINED POLYCHLORINATED BYPHENYLS ( HEREINAFTER REFERRED TO AS ' PCB ' ) IN VARIOUS PERCENTAGES ( WHICH DID NOT , HOWEVER , EXCEED THE MAXIMUM LIMIT ABOVE WHICH THEY COULD NOT LEGALLY BE MARKETED ), WITHOUT THERE BEING AFFIXED TO THE CONTAINERS LABELS INDICATING IN PARTICULAR THE PRESENCE OF PCB IN THE OIL .
3 MR CALDANA WAS PROSECUTED UNDER ITALIAN LAW NO 256/74 OF 29 MAY 1974 ON THE CLASSIFICATION , PACKAGING AND LABELLING OF DANGEROUS SUBSTANCES ( GAZZETTA UFFICIALE DELLA REPPUBLICA ITALIANA OF 9 JULY 1974 , P . 4543 ).
4 IT APPEARS FROM THE DOCUMENTS BEFORE THE COURT THAT THAT ITALIAN LAW , WHICH WAS FOLLOWED BY SEVERAL IMPLEMENTING DECREES , WAS INTENDED TO TRANSPOSE INTO ITALIAN NATIONAL LAW DIRECTIVE 67/548/EEC , MENTIONED ABOVE , AS MOST RECENTLY AMENDED BY DIRECTIVE 79/831/EEC . THE ORDER FOR REFERENCE STATES THAT THAT LAW AND THE DECREES ADOPTED FOR THE PURPOSE OF IMPLEMENTING IT HAVE BEEN THE SUBJECT OF TWO CONFLICTING INTERPRETATIONS AND THE ACCUSED WOULD BE ACQUITTED OR CONVICTED ACCORDING TO THE INTERPRETATION ADOPTED . IN THE INTERPRETATION ADOPTED BY THE MINISTRY OF HEALTH , THE RULES REGARDING LABELLING OF PACKAGES APPLY ONLY TO DANGEROUS SUBSTANCES AND NOT TO PREPARATIONS CONTAINING ONE OR MORE DANGEROUS SUBSTANCES THE PRESENCE OF WHICH IS REQUIRED TO BE INDICATED ON THE LABEL . ACCORDING TO THE INTERPRETATION ADOPTED BY THE CRIMINAL COURTS , THE OBLIGATION TO LABEL APPLIES EQUALLY TO PREPARATIONS .
5 IN THOSE CIRCUMSTANCES , THE PRETORE DI TORINO , CONSIDERING THAT AN INTERPRETATION OF THE ABOVEMENTIONED DIRECTIVE WAS NECESSARY IN ORDER TO INTERPRET NATIONAL LAW , STAYED THE PROCEEDINGS AND , BY AN ORDER OF 9 JULY 1984 , REFERRED TO THE COURT OF JUSTICE FOR A PRELIMINARY RULING 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 ' ' . '
6 ALL THE OBSERVATIONS SUBMITTED TO THE COURT ARRIVE AT THE SAME CONCLUSION , NAMELY THAT THE REPLY TO THE QUESTION SHOULD BE IN THE NEGATIVE .
7 THE DEFENDANT IN THE MAIN PROCEEDINGS CLAIMS , PRINCIPALLY , THAT MINERAL OILS FOR VEHICLES CONTAINING PCB ARE NOT ' PREPARATIONS ' WITHIN THE MEANING OF ARTICLE 2 ( 1 ) ( B ) OF COUNCIL DIRECTIVE 67/548/EEC , AS AMENDED BY DIRECTIVE 79/831/EEC OF 18 SEPTEMBER 1979 AND , IN THE ALTERNATIVE , THAT IN ANY EVENT , THE MERE FACT THAT A SUBSTANCE IS TO BE FOUND IN A PREPARATION , REGARDLESS OF THE PROPORTION OF THE MIXTURE WHICH IT REPRESENTS , IS NOT SUFFICIENT TO RENDER THAT PREPARATION ' DANGEROUS ' .
8 THE ITALIAN GOVERNMENT SUBMITS THAT ARTICLE 2 ( 2 ) OF DIRECTIVE 67/548/EEC DOES NOT PERMIT A PREPARATION TO BE CLASSIFIED AS DANGEROUS MERELY BECAUSE IT CONTAINS A DANGEROUS SUBSTANCE AND THAT , ACCORDING TO ARTICLE 4 ( 2 ) OF THE SAME DIRECTIVE , A SYSTEM OF RATINGS ENABLING THE HAZARD OF PREPARATIONS TO BE ASSESSED IS TO BE ESTABLISHED BY A SUBSEQUENT DIRECTIVE WHICH HAS NEVER BEEN ADOPTED , SO THAT THE PRESENT DIRECTIVE MERELY CONSTITUTES A STATEMENT OF INTENTION IN THAT REGARD . CONSEQUENTLY , ARTICLE 5 OF THAT DIRECTIVE MUST , ACCORDING TO THE ITALIAN GOVERNMENT , BE INTERPRETED , IN CONJUNCTION WITH ARTICLES 2 AND 4 , AS MEANING THAT THE ' SUBSTANCES ON THEIR OWN OR IN PREPARATIONS ' THEREIN REFERRED TO ARE THOSE ACTUALLY INDICATED IN THE DETAILED LIST AND PLACED ON THE MARKET AS SUCH . WITH REGARD TO ' DANGEROUS PREPARATIONS ' , THE DIRECTIVE MERELY LAYS DOWN SEVERAL PRINCIPLES WHICH CAN ONLY BE IMPLEMENTED AFTER THOSE ' PREPARATIONS ' HAVE BEEN DETERMINED .
9 THE COMMISSION SUBMITS THAT DIRECTIVE 67/548/EEC APPLIES AS A GENERAL RULE ONLY TO SUBSTANCES PLACED ON THE MARKET AS SUCH , AND THE PROVISIONS ALSO MENTIONING PREPARATIONS MUST BE REGARDED AS EXCEPTIONS . ALTHOUGH SOME PROVISIONS OF THE DIRECTIVE ALSO APPLY TO CERTAIN PREPARATIONS SUCH AS SOLVENTS , PESTICIDES , PAINTS , VARNISHES , PRINTING INKS , ADHESIVES AND SIMILAR PRODUCTS , THAT IS ONLY BY VIRTUE OF THE PROVISIONS OF THREE SPECIAL DIRECTIVES GOVERNING THOSE PREPARATIONS , WHICH EXPRESSLY REFER TO DIRECTIVE 67/548/EEC . THERE ARE THUS NO COMMUNITY RULES CONCERNING THE PACKAGING AND LABELLING OF MINERAL OILS FOR VEHICLES , NOR FOR PREPARATIONS OTHER THAN THOSE GOVERNED BY THE THREE SPECIAL DIRECTIVES .
10 IN ORDER TO REPLY TO THE QUESTION , A DISTINCTION MUST BE MADE BETWEEN , ON THE ONE HAND , THE MARKETING AND USE OF DANGEROUS SUBSTANCES AND PREPARATIONS AND , ON THE OTHER , THEIR PACKAGING AND LABELLING .
11 THE MARKETING AND USE OF DANGEROUS SUBSTANCES AND PREPARATIONS ARE GOVERNED BY COUNCIL DIRECTIVE 76/769 OF 27 JULY 1976 ON THE APPROXIMATION OF THE LAWS , REGULATIONS AND ADMINISTRATIVE PROVISIONS OF THE MEMBER STATES RELATING TO RESTRICTIONS ON THE MARKETING AND USE OF CERTAIN DANGEROUS SUBSTANCES AND PREPARATIONS ( OFFICIAL JOURNAL L 262 , P . 201 ), MOST RECENTLY AMENDED BY DIRECTIVE 82/828/EEC OF 10 DECEMBER 1982 ( OFFICIAL JOURNAL 1982 , L 350 , P . 34 ). THE LIST OF SUBSTANCES AND PREPARATIONS , AS WELL AS THE CONDITIONS UNDER WHICH THEY MAY BE MARKETED AND USED , IS CONTAINED IN THE ANNEX REFERRED TO IN ARTICLE 1 OF THAT DIRECTIVE . ACCORDING TO THE THIRD INDENT OF POINT 1 OF THAT ANNEX , PREPARATIONS CONTAINING PCB MAY , SUBJECT TO CERTAIN EXCEPTIONS , BE MARKETED ONLY IF THAT SUBSTANCE CONSTITUTES NO MORE THAN 0.1% OF THE WEIGHT OF THE PREPARATION . THE PROVISIONS OF THAT DIRECTIVE ARE NOT THE SUBJECT OF THE QUESTION SUBMITTED BY THE NATIONAL COURT .
12 WITH REGARD TO PACKAGING AND LABELLING , A DISTINCTION MUST BE DRAWN BETWEEN DANGEROUS SUBSTANCES AND DANGEROUS PREPARATIONS . WITH REGARD TO DANGEROUS SUBSTANCES , IT IS NOT DISPUTED THAT DIRECTIVE 67/548/EEC AS AMENDED CONTAINS PROVISIONS REGARDING THEIR PACKAGING , AND THE INFORMATION WHICH MUST BE ON THE PACKAGING OR ON LABELS AFFIXED THERETO . THE RELEVANT PROVISIONS ARE , IN PARTICULAR , THOSE CONTAINED IN ARTICLES 15 TO 18 . THE QUESTION SUBMITTED BY THE NATIONAL COURT SEEKS TO ASCERTAIN WHETHER THOSE PROVISIONS ALSO APPLY TO DANGEROUS PREPARATIONS . THE QUESTION AROSE BECAUSE VARIOUS PROVISIONS OF THAT DIRECTIVE ALSO MENTION PREPARATIONS ; IN PARTICULAR , ARTICLE 5 ( 1 ) STATES THAT ' THE MEMBER STATES SHALL TAKE ALL THE MEASURES NECESSARY TO ENSURE THAT . . . SUBSTANCES CANNOT BE PLACED ON THE MARKET ON THEIR OWN OR IN PREPARATIONS UNLESS THE SUBSTANCES HAVE BEEN : . . . 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 ' .
13 IT IS CLEAR FROM THE VERY TERMS OF ALL THE PROVISIONS CONTAINED IN ARTICLES 15 TO 18 , ARTICLE 6 AND ANNEX VI OF THE DIRECTIVE THAT THOSE PROVISIONS REFER ONLY TO SUBSTANCES AND NOT TO PREPARATIONS . THE QUESTION IS THEREFORE CONFINED TO WHETHER THEY ARE NONE THE LESS ALSO APPLICABLE TO PREPARATIONS BY VIRTUE OF THE WORDS ' OR IN PREPARATIONS ' IN ARTICLE 5 .
14 THE REPLY TO THAT QUESTION MUST BE IN THE NEGATIVE FOR SEVERAL REASONS .
15 IT SHOULD BE NOTED THAT , AS THE VERY TITLE OF THE DIRECTIVE SUGGESTS , THE MEASURES LAID DOWN THEREIN ARE APPLICABLE AS A GENERAL RULE ONLY TO DANGEROUS SUBSTANCES . ACCORDING TO ARTICLE 1 , AS AMENDED BY ARTICLE 1 OF DIRECTIVE 79/831/EEC , ' THE PURPOSE OF ( THE ) 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 ' .
16 FURTHERMORE , IN THE FOURTH RECITAL IN THE PREAMBLE TO THAT DIRECTIVE , THE COMMUNITY LEGISLATURE INDICATED ITS INTENTION IN THE FOLLOWING TERMS : ' 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 ' .
17 AS THE COMMISSION EXPLAINED IN ITS OBSERVATIONS , SPECIAL PROVISIONS WERE NECESSARY BECAUSE A PREPARATION IS NOT DANGEROUS MERELY BECAUSE IT CONTAINS A DANGEROUS SUBSTANCE . THE PROPORTION IN WHICH THAT SUBSTANCE IS PRESENT AND THE CHEMICAL EFFECTS OF SUCH PRESENCE MUST BE CONSIDERED . THE COUNCIL HAS ADOPTED ONLY THREE SPECIAL DIRECTIVES DEALING WITH CERTAIN PREPARATIONS SO FAR : SOLVENTS ( DIRECTIVE 73/173/EEC , OFFICIAL JOURNAL , L 189 OF 11 SEPTEMBER 1973 , P . 7 ), PAINTS , VARNISHES , PRINTING INKS , ADHESIVES AND SIMILAR PRODUCTS ( DIRECTIVE 77/728/EEC , OFFICIAL JOURNAL , L 303 OF 28 NOVEMBER 1977 , P . 23 ) AND PESTICIDES ( DIRECTIVE 78/631/EEC , OFFICIAL JOURNAL , L 206 OF 29 JULY 1978 , P . 13 ), WHICH REFER TO CERTAIN PROVISIONS OF DIRECTIVE 67/548/EEC AS REGARDS CLASSIFICATION , PACKAGING AND LABELLING OF SUCH PREPARATIONS .
18 FINALLY , IT MUST BE OBSERVED THAT THE REFERENCE TO DANGEROUS PREPARATIONS IN CERTAIN PROVISIONS OF DIRECTIVE 67/548/EEC IS SPECIFIC AND CANNOT GIVE RISE TO ANOTHER INTERPRETATION .
19 IN THOSE CIRCUMSTANCES , IT MUST BE HELD THAT IN COMMUNITY LAW THERE ARE AS YET NO COMMON OR HARMONIZED GENERAL RULES ON THE CLASSIFICATION , PACKAGING AND LABELLING OF DANGEROUS PREPARATIONS IN GENERAL AND THE MEMBER STATES ARE THUS ENTITLED TO ADOPT THE MEASURES THEY CONSIDER NECESSARY IN THAT REGARD . DIRECTIVE 67/548/EEC AS AMENDED BY DIRECTIVE 79/831/EEC THEREFORE REQUIRES LABELLING ONLY OF DANGEROUS SUBSTANCES AS SUCH AND NOT OF PREPARATIONS CONTAINING ONE OR MORE OF THOSE SUBSTANCES .