Criminal proceedings against Sandoz BV.
Date: 1983-07-14
11 IT APPEARS FROM THE FILE THAT VITAMINS ARE NOT IN THEMSELVES HARMFUL SUBSTANCES BUT ON THE CONTRARY ARE RECOGNIZED BY MODERN SCIENCE AS NECESSARY FOR THE HUMAN ORGANISM . NEVERTHELESS EXCESSIVE CONSUMPTION OF THEM OVER A PROLONGED PERIOD MAY HAVE HARMFUL EFFECTS , THE EXTENT OF WHICH VARIES ACCORDING TO THE TYPE OF VITAMIN : THERE IS GENERALLY A GREATER RISK WITH VITAMINS SOLUBLE IN FAT THAN WITH THOSE SOLUBLE IN WATER . ACCORDING TO THE OBSERVATIONS SUBMITTED TO THE COURT , HOWEVER , SCIENTIFIC RESEARCH DOES NOT APPEAR TO BE SUFFICIENTLY ADVANCED TO BE ABLE TO DETERMINE WITH CERTAINTY THE CRITICAL QUANTITIES AND THE PRECISE EFFECTS .
16 AS THE COURT FOUND IN ITS JUDGMENT OF 17 DECEMBER 1981 IN CASE 272/80 ( FRANS-NEDERLANDSE MAATSCHAPPIJ VOOR BIOLOGISCHE PRODUCTEN ( 1981 ) ECR 3277 ), IN SO FAR AS THERE ARE UNCERTAINTIES AT THE PRESENT STATE OF SCIENTIFIC RESEARCH IT IS FOR THE MEMBER STATES , IN THE ABSENCE OF HARMONIZATION , TO DECIDE WHAT DEGREE OF PROTECTION OF THE HEALTH AND LIFE OF HUMANS THEY INTEND TO ASSURE , HAVING REGARD HOWEVER FOR THE REQUIREMENTS OF THE FREE MOVEMENT OF GOODS WITHIN THE COMMUNITY .
17 THOSE PRINCIPLES ALSO APPLY TO SUBSTANCES SUCH AS VITAMINS WHICH ARE NOT AS A GENERAL RULE HARMFUL IN THEMSELVES BUT MAY HAVE SPECIAL HARMFUL EFFECTS SOLELY IF TAKEN TO EXCESS AS PART OF THE GENERAL NUTRITION , THE COMPOSITION OF WHICH IS UNFORESEEABLE AND CANNOT BE MONITORED . IN VIEW OF THE UNCERTAINTIES INHERENT IN THE SCIENTIFIC ASSESSMENT , NATIONAL RULES PROHIBITING , WITHOUT PRIOR AUTHORIZATION , THE MARKETING OF FOODSTUFFS TO WHICH VITAMINS HAVE BEEN ADDED ARE JUSTIFIED ON PRINCIPLE WITHIN THE MEANING OF ARTICLE 36 OF THE TREATY ON GROUNDS OF THE PROTECTION OF HUMAN HEALTH .
18 NEVERTHELESS THE PRINCIPLE OF PROPORTIONALITY WHICH UNDERLIES THE LAST SENTENCE OF ARTICLE 36 OF THE TREATY REQUIRES THAT THE POWER OF THE MEMBER STATES TO PROHIBIT IMPORTS OF THE PRODUCTS IN QUESTION FROM OTHER MEMBER STATES SHOULD BE RESTRICTED TO WHAT IS NECESSARY TO ATTAIN THE LEGITIMATE AIM OF PROTECTING HEALTH . ACCORDINGLY , NATIONAL RULES PROVIDING FOR SUCH A PROHIBITION ARE JUSTIFIED ONLY IF AUTHORIZATIONS TO MARKET ARE GRANTED WHEN THEY ARE COMPATIBLE WITH THE NEED TO PROTECT HEALTH .
19 SUCH AN ASSESSMENT IS , HOWEVER , DIFFICULT TO MAKE IN RELATION TO ADDITIVES SUCH AS VITAMINS THE ABOVEMENTIONED CHARACTERISTICS OF WHICH EXCLUDE THE POSSIBILITY OF FORESEEING OR MONITORING THE QUANTITIES CONSUMED AS PART OF THE GENERAL NUTRITION AND THE DEGREE OF HARMFULNESS OF WHICH CANNOT BE DETERMINED WITH SUFFICIENT CERTAINTY . NEVERTHELESS , ALTHOUGH IN VIEW OF THE PRESENT STAGE OF HARMONIZATION OF NATIONAL LAWS AT THE COMMUNITY LEVEL A     WIDE DISCRETION MUST BE LEFT TO THE MEMBER STATES , THEY MUST , IN ORDER TO OBSERVE THE PRINCIPLE OF PROPORTIONALITY , AUTHORIZE MARKETING WHEN THE ADDITION OF VITAMINS TO FOODSTUFFS MEETS A REAL NEED , ESPECIALLY A TECHNICAL OR NUTRITIONAL ONE .
20 THE FIRST QUESTION MUST THEREFORE BE ANSWERED TO THE EFFECT THAT COMMUNITY LAW PERMITS NATIONAL RULES PROHIBITING WITHOUT PRIOR AUTHORIZATION THE MARKETING OF FOODSTUFFS LAWFULLY MARKETED IN ANOTHER MEMBER STATE TO WHICH VITAMINS HAVE BEEN ADDED , PROVIDED THAT THE MARKETING IS AUTHORIZED WHEN THE ADDITION OF VITAMINS MEETS A REAL NEED , ESPECIALLY A TECHNICAL OR NUTRITIONAL ONE .

SECOND QUESTION
22 INASMUCH AS THE QUESTION ARISES AS TO WHERE THE ONUS OF PROOF LIES WHEN THERE IS A REQUEST FOR AUTHORIZATION , IN VIEW OF THE ANSWER TO THE FIRST QUESTION , IT MUST BE REMEMBERED THAT ARTICLE 36 OF THE TREATY CREATES AN EXCEPTION , WHICH MUST BE STRICTLY INTERPRETED , TO THE RULE OF FREE MOVEMENT OF GOODS WITHIN THE COMMUNITY WHICH IS ONE OF THE FUNDAMENTAL PRINCIPLES OF THE COMMON MARKET . IT IS THEREFORE FOR THE NATIONAL AUTHORITIES WHO RELY ON THAT  PROVISION IN ORDER TO ADOPT A MEASURE RESTRICTING INTRA-COMMUNITY TRADE TO CHECK IN EACH INSTANCE THAT THE MEASURE CONTEMPLATED SATISFIES THE CRITERIA OF THAT PROVISION .
26 AS REGARDS THE REQUIREMENT OF A MARKET DEMAND IT MUST BE EMPHASIZED THAT THE SOLE FACT OF IMPOSING SUCH A CONDITION CONSTITUTES IN ITSELF A MEASURE HAVING AN EQUIVALENT EFFECT TO A QUANTITATIVE RESTRICTION PROHIBITED BY ARTICLE 30 WHICH CANNOT BE COVERED BY THE EXCEPTION IN ARTICLE 36 . THE OBJECTIVE PURSUED BY THE PRINCIPLE OF FREE MOVEMENT OF GOODS IS PRECISELY TO ENSURE FOR PRODUCTS FROM THE VARIOUS MEMBER STATES ACCESS TO MARKETS ON WHICH THEY WERE NOT PREVIOUSLY REPRESENTED .