Judgment of the Court of 2 March 1983. - Commission of the European Communities v Kingdom of Belgium. - Phyto-pharmaceutical products - Conditions for approval. - Case 155/82.



European Court reports 1983 Page 00531



Summary

Parties

Subject of the case

Grounds

Decision on costs

Operative part



Keywords

FREE MOVEMENT OF GOODS - EXCEPTIONS - PROTECTION OF HEALTH - COMPETENCE OF MEMBER STATES - LIMITS - LEGISLATION RESTRICTING THE GRANTING OF APPROVAL OF PESTICIDES AND PHYTO-PHARMACEUTICAL PRODUCTS TO PERSONS ESTABLISHED ON ITS TERRITORY - JUSTIFICATION - LACK

( EEC TREATY , ARTS 30 AND 36 )

Summary

EACH MEMBER STATE IS ENTITLED TO TAKE WITHIN ITS TERRITORY , IN PARTICULAR IN A SPHERE IN WHICH THE OBJECTIVE OF HARMONIZATION OF HEALTH CONTROL MEASURES HAS NOT YET BEEN ACHIEVED , APPROPRIATE MEASURES IN ORDER TO ENSURE THE PROTECTION OF PUBLIC HEALTH . MOREOVER , SUCH MEASURES ARE JUSTIFIED ONLY IF IT IS ESTABLISHED THAT THEY ARE NECESSARY IN ORDER TO ATTAIN THE OBJECTIVE OF PROTECTION REFERRED TO IN ARTICLE 36 AND THAT SUCH PROTECTION CANNOT BE ACHIEVED BY MEANS WHICH PLACE LESS OF A RESTRICTION ON THE FREE MOVEMENT OF GOODS WITHIN THE COMMUNITY .

THAT IS NOT THE CASE WHERE THE LEGISLATION OF A MEMBER STATE RESTRICTS THE RIGHT TO APPLY FOR APPROVAL OF PESTICIDES FOR NON-AGRICULTURAL USE AND PHYTO-PHARMACEUTICAL PRODUCTS TO PERSONS ESTABLISHED ON ITS TERRITORY SINCE THE REQUIREMENT THAT A REPRESENTATIVE OF THE UNDERTAKINGS OF THE OTHER MEMBER STATES BE ESTABLISHED ON NATIONAL TERRITORY IS NOT SUCH AS TO PROVIDE , WITH A VIEW TO THE ATTAINMENT OF THE OBJECTIVE OF THE PROTECTION OF PUBLIC HEALTH , SUFFICIENT ADDITIONAL SAFEGUARDS TO JUSTIFY AN EXCEPTION TO THE PROHIBITION CONTAINED IN ARTICLE 30 OF THE TREATY .

Parties

IN CASE 155/82

COMMISSION OF THE EUROPEAN COMMUNITIES , REPRESENTED BY ITS LEGAL ADVISER , ROLF WAGENBAUR , ACTING AS AGENT , WITH AN ADDRESS FOR SERVICE IN LUXEMBOURG AT THE OFFICE OF ORESTE MONTALTO , A MEMBER OF ITS LEGAL DEPARTMENT , JEAN MONNET BUILDING , KIRCHBERG ,

APPLICANT ,

V

KINGDOM OF BELGIUM , REPRESENTED BY ROBERT HOEBAER , A DIRECTOR IN THE MINISTRY OF FOREIGN AFFAIRS , FOREIGN TRADE AND COOPERATION WITH DEVELOPING COUNTRIES , ACTING AS AGENT , ASSISTED BY R . HUYSMAN , INSPECTOR-IN-CHIEF AT THE MINISTRY OF PUBLIC HEALTH , WITH AN ADDRESS FOR SERVICE IN LUXEMBOURG AT THE BELGIAN EMBASSY ,

DEFENDANT ,

Subject of the case

APPLICATION FOR A DECLARATION THAT , BY RESTRICTING THE RIGHT TO APPLY FOR AUTHORIZATION OR APPROVAL OF PESTICIDES FOR NON-AGRICULTURAL USE AND PHYTO-PHARMACEUTICAL PRODUCTS TO PERSONS ESTABLISHED IN BELGIUM , THE KINGDOM OF BELGIUM HAS FAILED TO FULFIL ITS OBLIGATIONS UNDER ARTICLE 30 ET SEQ . OF THE EEC TREATY ,

Grounds

1 BY APPLICATION LODGED AT THE COURT REGISTRY ON 17 MAY 1982 , THE COMMISSION OF THE EUROPEAN COMMUNITIES BROUGHT AN ACTION UNDER ARTICLE 169 OF THE EEC TREATY FOR A DECLARATION THAT , BY RESTRICTING THE RIGHT TO APPLY FOR AUTHORIZATION OR APPROVAL FOR PESTICIDES FOR NON-AGRICULTURAL USE AND PHYTO-PHARMACEUTICAL PRODUCTS TO PERSONS ESTABLISHED IN BELGIUM , THE KINGDOM OF BELGIUM HAS FAILED TO FULFIL ITS OBLIGATIONS UNDER ARTICLE 30 ET SEQ . OF THE EEC TREATY .

2 BY THE ROYAL DECREE OF 5 JUNE 1975 ON THE STORAGE , MARKETING AND USE OF PESTICIDES AND PHYTO-PHARMACEUTICAL PRODUCTS ( MONITEUR BELGE , P . 13864 ), BELGIUM MADE THE MARKETING ON ITS TERRITORY OF PESTICIDES FOR NON-AGRICULTURAL USE AND PHYTO-PHARMACEUTICAL PRODUCTS , MORE FULLY DEFINED IN THE ABOVE-MENTIONED ROYAL DECREE , SUBJECT TO GOVERNMENTAL AUTHORIZATION . ARTICLE 12 OF THE DECREE PROVIDES THAT AUTHORIZATION MAY BE OBTAINED ONLY BY A PERSON ESTABLISHED IN BELGIUM WHO HAS RESPONSIBILITY FOR THE MARKETING OF ONE OF THOSE PRODUCTS AS A PRODUCER , IMPORTER , PROPRIETOR OR CONCESSIONNAIRE .

3 THE COMMISSION CONSIDERS THAT THE PROVISION , BY MAKING THE ADMISSION OF SUCH PRODUCTS CONDITIONAL ON THE REQUIREMENT OF HAVING A REPRESENTATIVE IN BELGIUM , HAS THE EFFECT OF PLACING NON-BELGIAN PRODUCERS AT A DISADVANTAGE AND , CONSEQUENTLY , CONSTITUTES AN OBSTACLE TO INTRA-COMMUNITY TRADE WHICH IS INCOMPATIBLE WITH ARTICLE 30 OF THE TREATY . IT POINTS OUT IN PARTICULAR THAT , ACCORDING TO ARTICLE 2 ( 3 ) ( G ) OF COMMISSION DIRECTIVE 70/50/EEC OF 22 DECEMBER 1969 , BASED ON THE PROVISIONS OF ARTICLE 33 ( 7 ), ON THE ABOLITION OF MEASURES WHICH HAVE AN EFFECT EQUIVALENT TO QUANTITATIVE RESTRICTIONS ON IMPORTS AND ARE NOT COVERED BY OTHER PROVISIONS ADOPTED IN PURSUANCE OF THE EEC TREATY ( OFFICIAL JOURNAL , ENGLISH SPECIAL EDITION 1970 ( I ), P . 17 ), MEASURES WHICH ' ' MAKE ACCESS OF IMPORTED PRODUCTS TO THE DOMESTIC MARKET CONDITIONAL UPON HAVING AN AGENT OR REPRESENTATIVE IN THE TERRITORY OF THE IMPORTING MEMBER STATE ' ' ARE TO BE CONSIDERED MEASURES HAVING AN EQUIVALENT EFFECT TO QUANTITATIVE RESTRICTIONS .

4 CONSEQUENTLY , THE COMMISSION COMMENCED THE PROCEDURE UNDER ARTICLE 169 OF THE TREATY AND , ON 23 OCTOBER 1981 , ISSUED A REASONED OPINION IN WHICH IT REQUESTED THE KINGDOM OF BELGIUM TO REMOVE FROM ITS LEGISLATION THE REQUIREMENT THAT THE RECIPIENT OF THE AUTHORIZATION TO MARKET ONE OF THE PRODUCTS IN QUESTION BE ESTABLISHED ON NATIONAL TERRITORY .

5 IN ITS STATEMENT OF 18 FEBRUARY 1982 , THE BELGIAN GOVERNMENT DECLARED THAT IT CONSIDERED THE DISPUTED MEASURE TO BE JUSTIFIED , IN VIEW OF THE DANGEROUS NATURE OF THE PRODUCTS CONCERNED , ON THE GROUND OF THE PROTECTION OF PUBLIC HEALTH .

6 FOLLOWING THAT STATEMENT , ON 17 MAY THE COMMISSION BROUGHT AN ACTION UNDER ARTICLE 169 .

7 IT IS NOT DISPUTED THAT THE REQUIREMENT IMPOSED BY THE BELGIAN LEGISLATION CONSTITUTES AN OBSTACLE TO THE IMPORTATION OF THE PRODUCTS CONCERNED INTO BELGIUM , INASMUCH AS IT COMPELS UNDERTAKINGS ESTABLISHED IN OTHER MEMBER STATES TO INCUR THE COST OF ESTABLISHING A REPRESENTATIVE IN BELGIUM , AND THAT IT MAY , AS A RESULT , MAKE IT DIFFICULT , IF NOT IMPOSSIBLE , FOR CERTAIN UNDERTAKINGS , IN PARTICULAR SMALL OR MEDIUM-SIZED UNDERTAKINGS TO ENTER THE BELGIAN MARKET .

8 THE BELGIAN GOVERNMENT ACKNOWLEDGES THAT THE REQUIREMENT CONSTITUTES AN IMPEDIMENT TO TRADE WITHIN THE COMMUNITY , BUT ARGUES THAT IT IS JUSTIFIED ON THE GROUND OF THE PROTECTION OF PUBLIC HEALTH , AS RECOGNIZED BY ARTICLE 36 OF THE TREATY .

9 IT POINTS OUT THAT THERE IS , AS YET , NO HARMONIZED SYSTEM OF APPROVAL AT COMMUNITY LEVEL IN THE SPHERE IN QUESTION , SO THAT EACH MEMBER STATE LAYS DOWN THE RULES FOR APPROVAL FOR ITS OWN TERRITORY . THE REQUIREMENT OF HAVING A REPRESENTATIVE ON NATIONAL TERRITORY IS , IN THAT RESPECT , ONLY ONE ELEMENT OF THE SYSTEM OF NATIONAL APPROVAL , TAKEN AS A WHOLE .

10 IT MAINTAINS THAT , IN VIEW OF THE CONSIDERABLE INCREASE IN THE USE OF THE PRODUCTS CONCERNED AND OF THE HIGH DEGREE OF TOXICITY OF CERTAIN OF THEM , STRICT MEASURES ARE NECESSARY FOR THEIR CONTROL AND FOR THE IMPOSITION OF LIABILITY . IN THAT RESPECT , THE REQUIREMENT THAT ANY PRODUCER WISHING TO MARKET A SPECIFIED PRODUCT MUST HAVE A REPRESENTATIVE ON BELGIAN TERRITORY WHO IS RESPONSIBLE FOR THE PRODUCT IS JUSTIFIED BY A NUMBER OF CONSIDERATIONS RELATING TO :

THE NEED TO ENSURE THE PROPER COMPLETION OF THE APPROVAL FORMALITIES , WHICH FOR CERTAIN PRODUCTS ARE PARTICULARLY COMPLICATED AND , AS A RESULT , REQUIRE DIRECT CONTACT BETWEEN THE APPLICANT AND THE ADMINISTRATION ;

THE ENFORCEMENT OF THE RULES CONCERNING THE LABELLING OF PRODUCTS ;

THE NEED TO CHECK THE CONFORMITY OF THE PRODUCT MARKETED WITH THE PRODUCT FOR WHICH THE APPROVAL WAS ISSUED ; AND

THE NECESSITY OF HAVING ON THE TERRITORY A PERSON WHO MAY BE CONTACTED EASILY AND QUICKLY IN THE EVENT OF AN ACCIDENT OR IN THE EVENT OF COMPLAINTS FROM USERS .

11 IN ADDITION , THE BELGIAN GOVERNMENT CLAIMS THAT ONLY THE ESTABLISHMENT ON NATIONAL TERRITORY OF A PERSON WITH RESPONSIBILITY FOR THE PRODUCT ENSURES THE EFFECTIVENESS OF PROSECUTIONS FOR INFRINGEMENTS OF PUBLIC HEALTH LEGISLATION .

12 THE PRINCIPLE BEHIND THE ARGUMENTS PUT FORWARD BY THE BELGIAN GOVERNMENT CAN NOT BE DISPUTED , INASMUCH AS EACH MEMBER STATE IS ENTITLED TO TAKE WITHIN ITS TERRITORY , IN PARTICULAR IN A SPHERE IN WHICH THE OBJECTIVE OF THE HARMONIZATION OF HEALTH CONTROL MEASURES HAS NOT YET BEEN ACHIEVED , APPROPRIATE MEASURES IN ORDER TO ENSURE THE PROTECTION OF PUBLIC HEALTH . HOWEVER , SUCH MEASURES ARE JUSTIFIED ONLY IF IT IS ESTABLISHED THAT THEY ARE NECESSARY IN ORDER TO ATTAIN THE OBJECTIVE OF PROTECTION REFERRED TO IN ARTICLE 36 AND THAT SUCH PROTECTION CANNOT BE ACHIEVED BY MEANS WHICH PLACE LESS OF A RESTRICTION ON THE FREE MOVEMENT OF GOODS WITHIN THE COMMUNITY .

13 IN THAT CONNECTION TWO OBSERVATIONS SHOULD BE MADE CONCERNING THE ARGUMENTS PUT FORWARD BY THE BELGIAN GOVERNMENT .

14 ON THE ONE HAND , IT SEEMS THAT THE OBJECTIVES PURSUED BY THE BELGIAN GOVERNMENT WITH REGARD TO THE COMPLETION OF THE APPROVAL FORMALITIES , THE RULES ON LABELLING , THE VERIFICATION OF THE CONFORMITY OF THE PRODUCT MARKETED WITH THE PRODUCT APPROVED AND THE AVAILABILITY OF INFORMATION IN THE EVENT OF AN ACCIDENT OR A COMPLAINT MAY BE FULLY SATISFIED BY APPROPRIATE ADMINISTRATIVE MEASURES TAKEN WHEN THE APPLICATION IS EXAMINED AND THE APPROVAL IS ISSUED , WITHOUT ITS BEING NECESSARY TO REQUIRE THE ESTABLISHMENT OF A REPRESENTATIVE ON NATIONAL TERRITORY .

15 ON THE OTHER HAND , QUESTIONS OF CRIMINAL LIABILITY ARE RELEVANT TO THE OBJECTIVE OF ARTICLE 36 ONLY IN SO FAR AS THE APPLICATION OF CRIMINAL PROVISIONS MAY HAVE A PREVENTIVE EFFECT . IN THAT RESPECT IT IS CLEAR THAT , AS FAR AS EFFECTIVE PREVENTION IS CONCERNED , ONLY THE PRELIMINARY FORMALITIES CONNECTED WITH THE ISSUE OF THE APPROVAL AND THE CHECKS CARRIED OUT AT THAT STAGE AND , POSSIBLY , AT THE MOMENT WHEN THE GOODS ARE PLACED ON THE MARKET CAN PROVIDE AN ADEQUATE SAFEGUARD FOR THE ATTAINMENT OF THE OBJECTIVE PURSUED BY ARTICLE 36 . EVEN THOUGH CRIMINAL PENALTIES MAY HAVE A DETERRENT EFFECT AS REGARDS THE CONDUCT WHICH THEY SANCTION , THAT EFFECT IS NOT GUARANTEED AND , IN ANY EVENT , IS NOT STRENGTHENED , IN THE CASE OF A MANUFACTURER IN ANOTHER MEMBER STATE WHO HAS BEEN ISSUED WITH AN APPROVAL , SOLELY BY THE PRESENCE ON NATIONAL TERRITORY OF A PERSON WHO MAY LEGALLY REPRESENT THE MANUFACTURER .

16 THE REQUIREMENT THAT A REPRESENTATIVE BE ESTABLISHED ON NATIONAL TERRITORY IS NOT THEREFORE SUCH AS TO PROVIDE , WITH A VIEW TO THE ATTAINMENT OF THE OBJECTIVE OF THE PROTECTION OF PUBLIC HEALTH , SUFFICIENT ADDITIONAL SAFEGUARDS TO JUSTIFY AN EXCEPTION TO THE PROHIBITION CONTAINED IN ARTICLE 30 .

17 IT MUST THEREFORE BE CONCLUDED THAT THE REQUIREMENT IMPOSED BY THE BELGIAN LEGISLATION , ACCORDING TO WHICH THE RIGHT TO APPLY FOR APPROVAL FOR PESTICIDES FOR NON-AGRICULTURAL USE AND PHYTO-PHARMACEUTICAL PRODUCTS IS RESTRICTED TO PERSONS ESTABLISHED IN BELGIUM , IS NOT JUSTIFIED UNDER ARTICLE 36 AND THEREFORE CONSTITUTES A RESTRICTION ON INTRA-COMMUNITY TRADE WHICH IS INCOMPATIBLE WITH ARTICLE 30 OF THE TREATY .

Decision on costs

COSTS

18 UNDER ARTICLE 69 ( 2 ) OF THE RULES OF PROCEDURE , THE UNSUCCESSFUL PARTY IS TO BE ORDERED TO PAY THE COSTS . SINCE THE DEFENDANT HAS FAILED IN ITS SUBMISSIONS IT MUST BE ORDERED TO PAY THE COSTS .

Operative part

ON THOSE GROUNDS ,

THE COURT

HEREBY :

1 . DECLARES THAT , BY RESTRICTING THE RIGHT TO APPLY FOR AUTHORIZATION OR APPROVAL FOR PESTICIDES FOR NON-AGRICULTURAL USE AND PHYTO-PHARMACEUTICAL PRODUCTS TO PERSONS ESTABLISHED IN BELGIUM , THE KINGDOM OF BELGIUM HAS FAILED TO FULFIL ITS OBLIGATIONS UNDER ARTICLE 30 ET SEQ . OF THE EEC TREATY ;

2 . ORDERS THE DEFENDANT TO PAY THE COSTS .