EUR-Lex -  61982CJ0174 - EN - Judgment of the Court (Fifth Chamber) of 14 July 1983. - Criminal proceedings against Sandoz BV. - Reference for a preliminary ruling: Arrondissementsrechtbank 's-Hertogenbosch - Netherlands. - Free movement of goods - Restrictions justified on grounds of the protection of health. - Case 174/82.
Karar Dilini Çevir:

Summary
Parties
Subject of the case
Grounds
Decision on costs
Operative part
Keywords

1 . FREE MOVEMENT OF GOODS - QUANTITATIVE RESTRICTIONS - MEASURES HAVING EQUIVALENT EFFECT - CONCEPT - NATIONAL RULES PROHIBITING WITHOUT PRIOR AUTHORIZATION THE MARKETING OF FOODSTUFFS TO WHICH VITAMINS HAVE BEEN ADDED - RULES COVERED BY THAT CONCEPT

( EEC TREATY , ARTICLE 30 )

2 . FREE MOVEMENT OF GOODS - DEROGATIONS - PROTECTION OF HUMAN HEALTH - NATIONAL RULES PROHIBITING WITHOUT PRIOR AUTHORIZATION THE MARKETING OF FOODSTUFFS TO WHICH VITAMINS HAVE BEEN ADDED - JUSTIFICATION - LIMITS - ADDITION OF VITAMINS MEETING A REAL TECHNICAL OR NUTRITIONAL NEED

( EEC TREATY , ARTICLE 36 )

3 . FREE MOVEMENT OF GOODS - DEROGATIONS - PROTECTION OF HUMAN HEALTH - NATIONAL RULES PROHIBITING WITHOUT PRIOR AUTHORIZATION THE MARKETING OF FOODSTUFFS TO WHICH VITAMINS HAVE BEEN ADDED - AUTHORIZATION SUBJECT TO PROOF BY THE IMPORTER OF THE HARMLESSNESS OF THE PRODUCT - JUSTIFICATION - NONE

( EEC TREATY , ARTICLE 36 )

4 . FREE MOVEMENT OF GOODS - QUANTITATIVE RESTRICTIONS - MEASURES HAVING EQUIVALENT EFFECT - NATIONAL RULES PROHIBITING WITHOUT PRIOR AUTHORIZATION THE MARKETING OF FOODSTUFFS TO WHICH VITAMINS HAVE BEEN ADDED - AUTHORIZATION SUBJECT TO PROOF BY THE IMPORTER OF A MARKET DEMAND FOR THE PRODUCT - JUSTIFICATION - NONE

( EEC TREATY , ARTICLES 30 AND 36 )

Summary

1 . ALL COMMERCIAL RULES OF THE MEMBER STATES LIKELY TO IMPEDE DIRECTLY OR INDIRECTLY , ACTUALLY OR POTENTIALLY , INTRA-COMMUNITY TRADE ARE TO BE REGARDED AS MEASURES HAVING AN EFFECT EQUIVALENT TO QUANTITATIVE RESTRICTIONS .

SUCH IS THE CASE OF NATIONAL RULES WHICH PROHIBIT WITHOUT PRIOR AUTHORIZATION THE MARKETING OF FOODSTUFFS LAWFULLY MARKETED IN ANOTHER MEMBER STATE TO WHICH VITAMINS HAVE BEEN ADDED .

2 . IN VIEW OF THE UNCERTAINTIES INHERENT IN THE SCIENTIFIC ASSESSMENT OF THE HARMFULNESS OF VITAMINS , 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 .

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 .

ALTHOUGH IN VIEW OF THE PRESENT STAGE OF HARMONIZATION OF NATIONAL LAWS AT 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 .

3 . COMMUNITY LAW DOES NOT PERMIT NATIONAL RULES WHICH SUBJECT AUTHORIZATION TO MARKET FOODSTUFFS LAWFULLY MARKETED IN ANOTHER MEMBER STATE TO WHICH VITAMINS HAVE BEEN ADDED TO PROOF BY THE IMPORTER THAT THE PRODUCT IN QUESTION IS NOT HARMFUL TO HEALTH , WITHOUT PREJUDICE TO THE RIGHT OF THE NATIONAL AUTHORITIES TO ASK THE IMPORTER TO SUBMIT ALL THE INFORMATION IN HIS POSSESSION NEEDED TO ASSESS THE FACTS .

4 . COMMUNITY LAW DOES NOT PERMIT NATIONAL RULES WHICH SUBJECT AUTHORIZATION TO MARKET FOODSTUFFS LAWFULLY MARKETED IN ANOTHER MEMBER STATE TO WHICH VITAMINS HAVE BEEN ADDED TO PROOF BY THE IMPORTER THAT THE MARKETING OF THE PRODUCT IN QUESTION MEETS A MARKET DEMAND .

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 .

Parties

IN CASE 174/82

REFERENCE TO THE COURT UNDER ARTICLE 177 OF THE EEC TREATY BY THE ARRONDISSEMENTSRECHTBANK ( DISTRICT COURT ), S ' HERTOGENBOSCH , FOR A PRELIMINARY RULING IN THE CRIMINAL PROCEEDINGS PENDING BEFORE THAT COURT AGAINST

SANDOZ BV , UDEN ,

Subject of the case

FOR A PRELIMINARY RULING ON THE INTERPRETATION OF THE PROVISIONS OF THE EEC TREATY ON THE FREE MOVEMENT OF GOODS WITHIN THE COMMUNITY AND IN PARTICULAR ARTICLE 36 OF THE TREATY ,

Grounds

1 BY JUDGMENT OF 3 MAY 1982 , RECEIVED AT THE COURT ON 28 JUNE 1982 , THE ECONOMISCHE POLITIERECHTER ( MAGISTRATE DEALING WITH COMMERCIAL OFFENCES ) FOR THE ARRONDISSEMENTSRECHTBANK ( DISTRICT COURT ), ' S-HERTOGENBOSCH , REFERRED TO THE COURT UNDER ARTICLE 177 OF THE EEC TREATY FOR A PRELIMINARY RULING THREE QUESTIONS ON THE INTERPRETATION OF PROVISIONS OF THE EEC TREATY IN RELATION TO FREE MOVEMENT OF GOODS WITHIN THE COMMUNITY AND IN PARTICULAR ARTICLE 36 THEREOF .

2 THE QUESTIONS WERE RAISED IN CRIMINAL PROCEEDINGS BROUGHT AGAINST SANDOZ BV , UDEN , FOR HAVING SOLD AND DELIVERED IN THE NETHERLANDS FOR COMMERCIAL PURPOSES AND FOR HUMAN CONSUMPTION , WITHOUT AN AUTHORIZATION FROM THE RESPONSIBLE MINISTER , FOOD AND BEVERAGES TO WHICH VITAMINS HAD BEEN ADDED .

3 ACCORDING TO ARTICLE 10 ( A ) ( 1 ) OF THE ALGEMEEN BESLUIT ( GENERAL DECREE ) OF 11 JULY 1949 ADOPTED IN IMPLEMENTATION OF ARTICLES 14 AND 15 OF THE WARENWET ( FOOD AND DRUGS LAW ) OF 1935 ' ' NO VITAMINS . . . MAY BE ADDED TO FOOD AND BEVERAGES WITHOUT AN AUTHORIZATION GRANTED BY THE MINISTER RESPONSIBLE FOR IMPLEMENTING THIS DECREE ' ' .

4 IN THE PRESENT CASE SANDOZ BV ( HEREINAFTER REFERRED TO AS ' ' SANDOZ ' ' ) SOLD IN THE NETHERLANDS MUESLI BARS , ' ' POWERBACK ' ' AND ANALEPTIC BEVERAGES TO WHICH CERTAIN VITAMINS , IN PARTICULAR VITAMINS A AND D , HAD BEEN ADDED . IT APPEARS FROM THE FILE THAT ALL THE PRODUCTS IN QUESTION ARE LAWFULLY MARKETED IN THE FEDERAL REPUBLIC OF GERMANY OR IN BELGIUM . BEFORE MARKETING THEM IN THE NETHERLANDS SANDOZ APPLIED FOR AUTHORIZATION PURSUANT TO THE AFORESAID LEGISLATION . THE RESPONSIBLE NETHERLANDS AUTHORITY REPLIED FIRST THAT AUTHORIZATION WOULD BE GRANTED ONLY IF THERE WAS A MARKET DEMAND FOR THE PRODUCTS IN QUESTION . THE APPLICATION FOR AUTHORIZATION WAS SUBSEQUENTLY REJECTED ON THE GROUND THAT THE VITAMINS A AND D IN THE PRODUCTS IN QUESTION REPRESENTED A DANGER TO PUBLIC HEALTH .

5 THE ECONOMISCHE POLITIERECHTER TOOK THE VIEW THAT HIS DECISION ON THE MATTER DEPENDED ON WHETHER THE AFORESAID NETHERLANDS LEGISLATION WAS COMPATIBLE WITH ARTICLE 30 ET SEQ . OF THE TREATY AND THEREFORE AN INTERPRETATION OF THOSE PROVISIONS WAS NECESSARY FOR HIM TO GIVE JUDGMENT ; THE PROCEEDINGS WERE THEREUPON STAYED AND THE FOLLOWING QUESTIONS REFERRED TO THE COURT FOR A PRELIMINARY RULING :

' ' 1 . WHERE :

( A ) FOOD OR BEVERAGES , OR BOTH , TO WHICH VITAMINS HAVE BEEN ADDED , HAVE BEEN MARKETED IN ONE OR MORE MEMBER STATES LAWFULLY , THAT IS TO SAY IN ACCORDANCE WITH THE LEGISLATION IN FORCE LOCALLY , AND

( B)AN IMPORTER OF FOOD OR BEVERAGES , OR BOTH , ESTABLISHED IN ANOTHER MEMBER STATE IMPORTS LAWFULLY MARKETED FOOD OR BEVERAGES , OR BOTH , TO WHICH VITAMINS HAVE BEEN ADDED , FROM ONE OF THE MEMBER STATES REFERRED TO UNDER ( A ) ABOVE INTO THE MEMBER STATE IN WHICH HE IS ESTABLISHED ,

DO THE PROVISIONS DEROGATING FROM THE RULES CONCERNING THE FREE MOVEMENT OF GOODS WITHIN THE COMMUNITY , IN PARTICULAR ARTICLE 36 OF THE EEC TREATY IN SO FAR AS IT RELATES TO THE PROTECTION OF THE HEALTH OF HUMANS , JUSTIFY THE GOVERNMENT OF THE MEMBER STATE OF IMPORTATION IN PROHIBITING THE MARKETING OF SUCH FOOD OR BEVERAGES , OR BOTH , IN THAT STATE WITHOUT MINISTERIAL AUTHORIZATION?

2.MUST THE PREVIOUS QUESTION BE ANSWERED DIFFERENTLY IF THE GENERAL PROHIBITION ON THE SALE OF FOOD AND BEVERAGES TO WHICH VITAMINS HAVE BEEN ADDED , UNLESS AUTHORIZED BY A MINISTERIAL DECISION , HAS THE RESULT THAT THE IMPORTER REFERRED TO UNDER 1 ( B ) ABOVE BEARS THE ONUS OF PROVING THAT THE FOOD AND BEVERAGES CONCERNED ARE NOT A DANGER TO PUBLIC HEALTH AND MUST THEREFORE BE AUTHORIZED?

3.MUST THE QUESTION BE ANSWERED DIFFERENTLY IF THE APPLICATION OF THE GENERAL PROHIBITION OF THE SALE OF FOOD AND BEVERAGES TO WHICH VITAMINS HAVE BEEN ADDED , UNLESS AUTHORIZED BY A MINISTERIAL DECISION , HAS THE RESULT THAT THE NATIONAL AUTHORITIES OF A MEMBER STATE PROHIBIT THE SALE OF SUCH FOOD AND BEVERAGES WHICH HAVE BEEN LAWFULLY PRODUCED AND MARKETED IN ANOTHER MEMBER STATE , UNLESS THE PRODUCER OR SELLER SHOWS NOT ONLY THAT SUCH PRODUCTS ARE NOT A DANGER TO HEALTH BUT ALSO THAT IT IS DESIRABLE TO MARKET THEM AND THAT THERE IS A NEED FOR VITAMINS TO BE ADDED?

' ' .

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