1 BY AN APPLICATION LODGED AT THE COURT REGISTRY ON 3 MARCH 1987 PFIZER INTERNATIONAL INC . BROUGHT AN ACTION UNDER THE SECOND PARAGRAPH OF ARTICLE 173 AND ARTICLE 174 OF THE EEC TREATY FOR A DECLARATION THAT THE FOLLOWING CONDUCT OF THE COMMISSION IS VOID :
PROPOSING TO THE STANDING COMMITTEE FOR FEEDINGSTUFFS ( HEREINAFTER REFERRED TO AS "THE STANDING COMMITTEE ") AS LATE AS 17 NOVEMBER 1986, PURSUANT TO ARTICLE 23*(3 ) OF COUNCIL DIRECTIVE 70/524, THAT CARBADOX BE TRANSFERRED FROM ANNEX II TO ANNEX I OF THE DIRECTIVE, WITHOUT AT THE SAME TIME PROPOSING TO RENEW THE PERIOD OF AUTHORIZATION UNDER ANNEX II; SINCE THE PREVIOUS PERIOD EXPIRED ON 3 DECEMBER 1986 AS A RESULT OF COMMISSION DIRECTIVE 85/520 OF 11 NOVEMBER 1985 ( OFFICIAL JOURNAL 1985 L*323, P . 12 ) AMENDING COMMISSION DIRECTIVE 85/429 ( OFFICIAL JOURNAL 1985 L*245, P . 1 ), AMENDING THE ANNEXES TO COUNCIL DIRECTIVE 70/524, CARBADOX HAS CEASED TO BE AUTHORIZED UNDER ANNEX II DURING THE PERIOD BEFORE AUTHORIZATION IS GRANTED UNDER ANNEX I; AND
OMITTING, AFTER THE STANDING COMMITTEE HAD FAILED, ON 22 DECEMBER 1986, TO DELIVER AN OPINION ON THE COMMISSION' S PROPOSAL TO INCLUDE CARBADOX IN ANNEX I OF COUNCIL DIRECTIVE 70/524, TO SUBMIT WITHOUT DELAY TO THE COUNCIL, PURSUANT TO ARTICLE 23*(4 ) OF THAT DIRECTIVE, A PROPOSAL TO INCLUDE THE ADDITIVE IN ANNEX I .
2 BY AN APPLICATION LODGED AT THE COURT REGISTRY ON THE SAME DAY THE APPLICANT REQUESTED THE COURT, UNDER ARTICLE 186 OF THE EEC TREATY AND ARTICLE 83 OF THE RULES OF PROCEDURE, TO MAKE AN INTERIM ORDER THAT THE COMMISSION SHOULD, FIRST OF ALL, PROPOSE TO THE STANDING COMMITTEE, WITHIN TWO DAYS OF THE DELIVERY OF THE ORDER GRANTING THE APPLICATION, THAT CARBADOX BE AGAIN INCLUDED IN ANNEX II OF COUNCIL DIRECTIVE 70/524 AND, SECONDLY, INFORM THE COMPETENT AUTHORITIES OF THE MEMBER STATES OF THAT INTERIM ORDER WITHIN THE SAME PERIOD .
3 THE DEFENDANT SUBMITTED WRITTEN OBSERVATIONS ON 19 MARCH 1987 . THE PARTIES PRESENTED ORAL ARGUMENT ON 3 APRIL 1987 .
4 BEFORE CONSIDERING THE MERITS OF THIS APPLICATION FOR INTERIM MEASURES, IT MAY BE USEFUL TO SET OUT BRIEFLY THE LEGISLATIVE BACKGROUND TO THIS CASE AND THE EVENTS WHICH LED THE APPLICANT TO BRING THE AFORESAID ACTION FOR ANNULMENT .
5 CARBADOX IS A SWINE GROWTH PROMOTER WHICH PFIZER HAS DEVELOPED AND SELLS TO THE WORLD ANIMAL FEED INDUSTRY . THE PARTICULAR FEATURE OF CARBADOX IS THAT IT NOT ONLY PROMOTES THE GROWTH OF PIGS RAISED FOR HUMAN CONSUMPTION BUT ALSO ALLOWS LIVESTOCK FARMERS TO USE FAR LESS FEED THAN WOULD OTHERWISE BE REQUIRED .
6 A COMMUNITY POLICY ON ADDITIVES WAS ESTABLISHED BY THE ADOPTION ON 23 NOVEMBER 1970 OF COUNCIL DIRECTIVE 70/524 CONCERNING ADDITIVES IN FEEDINGSTUFFS . THE COUNCIL ADOPTED THE APPROACH OF DRAWING UP TWO ANNEXES UPON A PROPOSAL FROM THE COMMISSION . THE PARTICULAR FEATURES OF THOSE ANNEXES ARE AS FOLLOWS :
ANNEX I CONTAINS A LIST OF ADDITIVES WHICH ARE, IN PRINCIPLE, THE ONLY ADDITIVES WHOSE MARKETING AND USE IN FEEDINGSTUFFS ARE TO BE AUTHORIZED BY THE MEMBER STATES; THE ONLY REQUIREMENT IS THAT THEY SHOULD COMPLY WITH THE CONDITIONS GOVERNING THEIR USE LAID DOWN BY THE DIRECTIVE .
ANNEX II CONTAINS ADDITIVES WHICH, PROVIDED THAT THEY SATISFY CERTAIN REQUIREMENTS LAID DOWN IN ARTICLE 6*(2 ) OF THE DIRECTIVE, MAY EXCEPTIONALLY, BY WAY OF DEROGATION FROM ANNEX I, BE AUTHORIZED TEMPORARILY BY THE MEMBER STATES UNTIL IT HAS BEEN DETERMINED, BY INVESTIGATION, WHETHER THEY MAY BE DEFINITIVELY AUTHORIZED, THAT IS TO SAY, BE INCLUDED IN ANNEX I ( AND HENCE DELETED FROM ANNEX II ).
UNDER ARTICLE 4*(1 ) OF THE DIRECTIVE, SUCH AUTHORIZATION COULD BE GRANTED FOR A PERIOD OF FIVE YEARS FROM 23 NOVEMBER 1970 .
7 CARBADOX WAS INCLUDED FOR THE FIRST TIME IN ANNEX II BY THE EIGHTH COMMISSION DIRECTIVE OF 1 JULY 1974 ( 74/378/EEC ) AMENDING THE ANNEXES OF DIRECTIVE 70/524 ( OFFICIAL JOURNAL 1974, L*199, P . 13 ).
8 ARTICLE 9 OF COUNCIL DIRECTIVE 75/296 OF 28 APRIL 1975 AMENDING DIRECTIVE 70/524 ( OFFICIAL JOURNAL 1975, L*124, P . 29 ) AMENDED ANNEX II BY ADDING A COLUMN ENTITLED "PERIOD OF AUTHORIZATION" WHICH EXTENDED UNTIL 30 JUNE 1976 THE PERIOD OF AUTHORIZATION FOR ALL ADDITIVES APPEARING IN THE ANNEX BEFORE 1 MAY 1975 . SUBSEQUENTLY, PURSUANT TO ARTICLE 16*(A ) OF DIRECTIVE 70/524 AND LATER ARTICLE 23, WHICH REPLACED ARTICLE 16*(A ) AS A RESULT OF COUNCIL DIRECTIVE 84/587 OF 29 NOVEMBER 1984 AMENDING DIRECTIVE 70/524 ( OFFICIAL JOURNAL 1984, L*319, P . 13 ), THE COMMISSION ADOPTED 12 DIRECTIVES EXTENDING THE PERIOD OF AUTHORIZATION FOR CARBADOX PROVIDED FOR IN ANNEX II ON THE GROUND THAT THE INVESTIGATIONS INTO THE PRODUCT HAD NOT YET BEEN COMPLETED . THE LAST OF THOSE DIRECTIVES, DIRECTIVE 85/520 OF 11 NOVEMBER 1985 AMENDING COMMISSION DIRECTIVE 85/429, AMENDING THE ANNEXES TO COUNCIL DIRECTIVE 70/524 ( OFFICIAL JOURNAL 1985, L*323, P . 12 ), EXTENDED THE PERIOD OF AUTHORIZATION FOR CARBADOX TO 3 DECEMBER 1986 .
9 FOLLOWING TWO FAVOURABLE REPORTS FROM THE SCIENTIFIC COMMITTEE FOR ANIMAL NUTRITION CONCERNING THE USE OF CARBADOX DATED 6 JULY 1978 AND 7 JULY 1982, THE COMMISSION CONCLUDED THAT THE INVESTIGATIONS HAD PROVIDED SUFFICIENT EVIDENCE THAT THE SUBSTANCE WAS INNOCUOUS; CONSEQUENTLY, ON 19 NOVEMBER 1986 THE COMMISSION PROPOSED TO THE STANDING COMMITTEE, PURSUANT TO ARTICLE 23*(3 ) OF DIRECTIVE 70/524, THAT CARBADOX BE INCLUDED IN ANNEX I . ON 22 DECEMBER 1986 THE STANDING COMMITTEE EXAMINED THE COMMISSION' S PROPOSAL BUT WAS UNABLE TO DELIVER AN OPINION BECAUSE CERTAIN MEMBER STATES VOTED AGAINST THE PROPOSAL THUS PREVENTING THE REQUISITE MAJORITY FROM BEING ACHIEVED .
10 ON 12 MARCH 1987 THE COMMISSION SUBMITTED TO THE COUNCIL, PURSUANT TO ARTICLE 23*(4 ) OF DIRECTIVE 70/524, A PROPOSAL FOR A DIRECTIVE INCLUDING CARBADOX IN ANNEX I .
11 PURSUANT TO ARTICLE 186 OF THE EEC TREATY, THE COURT OF JUSTICE MAY IN CASES BEFORE IT PRESCRIBE ANY NECESSARY INTERIM MEASURES .
12 AS A CONDITION FOR THE GRANT OF A MEASURE SUCH AS THAT REQUESTED, ARTICLE 83*(2 ) OF THE RULES OF PROCEDURE PROVIDES THAT AN APPLICATION FOR INTERIM MEASURES MUST STATE THE CIRCUMSTANCES GIVING RISE TO URGENCY AND THE FACTUAL AND LEGAL GROUNDS ESTABLISHING A PRIMA-FACIE CASE FOR THE INTERIM MEASURES APPLIED FOR .
13 BEFORE EXAMINING THE ARGUMENTS PUT FORWARD BY THE APPLICANT TO SHOW THAT ITS APPLICATION SATISFIES THE CONDITIONS FOR THE GRANT OF INTERIM MEASURES, IT IS NECESSARY TO CONSIDER BRIEFLY A QUESTION RAISED BY THE DEFENDANT CONCERNING THE ADMISSIBILITY OF THE MAIN APPLICATION .
14 THE COMMISSION CONTENDS FIRSTLY THAT IT HAS NOT ADOPTED ANY ACT CAPABLE OF REVIEW BY THE COURT UNDER ARTICLE 173 OF THE EEC TREATY AND, SECONDLY, THAT THE APPLICANT' S COMPLAINT RELATES RATHER TO A FAILURE TO ACT WHICH MAY ONLY BE CHALLENGED UNDER ARTICLE 175 OF THE EEC TREATY . THE MAIN APPLICATION SHOULD THEREFORE BE DECLARED INADMISSIBLE OR, IN ANY EVENT, MANIFESTLY UNFOUNDED; AN ESSENTIAL CONDITION FOR THE GRANT OF INTERIM MEASURES, NAMELY THE EXISTENCE OF A PRIMA-FACIE CASE, IS THEREFORE NOT MET .
15 IN THAT REGARD IT SHOULD BE NOTED THAT THE COURT HAS REPEATEDLY STRESSED THAT THE ISSUE OF THE ADMISSIBILITY OF THE MAIN APPLICATION SHOULD NOT, IN PRINCIPLE, BE EXAMINED IN PROCEEDINGS RELATING TO AN APPLICATION FOR INTERIM MEASURES, BUT SHOULD BE RESERVED FOR THE EXAMINATION OF THE MAIN APPLICATION SO AS NOT TO PREJUDGE THAT APPLICATION ( SEE IN PARTICULAR CASE 75/72*R PERINCIOLO V COUNCIL (( 1972 )) ECR 1203; CASE 186/80*R SUSS V COMMISSION (( 1980 )) ECR 3501; CASE 351/85*R FABRIQUE DE FER DE CHARLEROI V COMMISSION (( 1986 )) ECR 1307; AND CASE 23/86*R UNITED KINGDOM V EUROPEAN PARLIAMENT (( 1986 )) ECR 1085 ). CONSEQUENTLY, THE QUESTION OF ADMISSIBILITY RAISED BY THE COMMISSION WILL NOT BE EXAMINED IN THESE INTERLOCUTORY PROCEEDINGS .
16 THE COURT HAS CONSISTENTLY HELD THAT THE URGENCY REQUIRED BY ARTICLE 83*(2 ) OF THE RULES OF PROCEDURE IN REGARD TO AN APPLICATION FOR INTERIM MEASURES MUST BE ASSESSED ON THE BASIS OF THE NEED TO ADOPT SUCH MEASURES IN ORDER TO AVOID SERIOUS AND IRREPARABLE DAMAGE TO THE PARTY SEEKING THOSE MEASURES .
17 IN THAT REGARD THE APPLICANT OBSERVES THAT AS A RESULT OF THE COMMISSION' S CONDUCT CARBADOX HAS BEEN DELETED FROM ANNEX II AS FROM 3 NOVEMBER 1986 WITHOUT BEING INCLUDED IN ANNEX I FROM THAT DATE; CONSEQUENTLY, FROM THAT DATE CARBADOX CAN NO LONGER BE LEGALLY MARKETED IN THE EEC, SINCE ARTICLE 3*(2 ) OF DIRECTIVE 70/524 REQUIRES MEMBER STATES TO PROHIBIT THE SALE AND MARKETING OF ANY ADDITIVE WHICH IS NOT INCLUDED IN ONE OF THE TWO ANNEXES .
18 THE APPLICANT CLAIMS THAT THIS SITUATION IS CAUSING IT SERIOUS AND IRREPARABLE DAMAGE . THE SERIOUSNESS OF THE DAMAGE ARISES FROM THE FACT THAT SINCE 22 DECEMBER 1986 WHEN THE VOTE WAS TAKEN WITHIN THE STANDING COMMITTEE A SHARP DECREASE IN ORDERS PLACED FOR CARBADOX HAS BEEN NOTED . SALES IN, FOR EXAMPLE, BELGIUM, FRANCE AND THE FEDERAL REPUBLIC OF GERMANY HAVE DECREASED BY 15, 39 AND 44% RESPECTIVELY, THUS CAUSING SEVERE FINANCIAL LOSS . THE DAMAGE IS, MOREOVER, IRREPARABLE SINCE THE LOST MARKET SHARES ARE BEING TAKEN OVER BY COMPETING PRODUCTS . IT WILL BE DIFFICULT, NOT TO SAY PRACTICALLY IMPOSSIBLE, FOR CARBADOX TO REGAIN A PLACE ON THE MARKET IN SWINE GROWTH PROMOTERS IF IT CONTINUES TO BE ABSENT FOR LONG . IN ADDITION, IN VIEW OF THE BENEFICIAL EFFECTS OF CARBADOX MENTIONED IN PARAGRAPH 5 OF THIS ORDER, DAMAGE WILL ALSO BE SUFFERED BY FARMERS AND BY MANUFACTURERS OF ANIMAL FEED .
19 THE APPLICANT HAS SUCCEEDED IN PUTTING FORWARD ARGUMENTS WHICH, AT FIRST SIGHT, INDICATE THAT IT WOULD SUFFER SERIOUS AND IRREPARABLE DAMAGE IF THE INTERIM MEASURE WHICH IT REQUESTS WERE NOT GRANTED .
20 WHILST THE REQUIREMENT OF URGENCY APPEARS TO BE SATISFIED, IT STILL REMAINS TO BE EXAMINED WHETHER THE APPLICANT HAS PUT FORWARD GROUNDS ESTABLISHING A PRIMA-FACIE CASE FOR THE INTERIM MEASURES APPLIED FOR . SUCH AN EXAMINATION SEEMS ALL THE MORE NECESSARY SINCE THE APPLICANT WILL CONTINUE TO SUFFER DAMAGE UNTIL AT LEAST 30 NOVEMBER 1987, IN VIEW OF THE FACT THAT, UNDER ARTICLE 2 OF THE PROPOSAL FOR A DIRECTIVE SUBMITTED BY THE COMMISSION TO THE COUNCIL ON 12 MARCH 1987 WITH A VIEW TO THE INCLUSION OF CARBADOX IN ANNEX I, THE MEMBER STATES ARE NOT REQUIRED TO BRING THEIR LEGISLATION INTO CONFORMITY WITH THE DIRECTIVE UNTIL THAT DATE .
21 IN THAT REGARD THE APPLICANT REFERS TO THE VARIOUS SUBMISSIONS WHICH IT HAS PUT FORWARD IN SUPPORT OF ITS MAIN APPLICATION . IN PARTICULAR IT ARGUES THAT THE DEFENDANT, BY FAILING TO TAKE THE NECESSARY MEASURES TO ENSURE THAT CARBADOX CONTINUED TO BE INCLUDED IN ANNEX II PENDING ITS INCLUSION IN ANNEX I AFTER PREVIOUSLY EXTENDING ITS INCLUSION IN ANNEX II 12 TIMES, INFRINGED THE GENERAL PRINCIPLES OF LEGAL CERTAINTY AND LEGITIMATE EXPECTATIONS . THAT OMISSION ALSO CAUSED CARBADOX TO BE DISCRIMINATED AGAINST VIS-A-VIS POSSIBLE SUBSTITUTE PRODUCTS LISTED IN ANNEX I OR IN ANNEX II .
22 FOR ITS PART, THE DEFENDANT MERELY CONTENDS THAT IT NO LONGER HAD THE POWER TO INCLUDE CARBADOX IN ANNEX II AGAIN AFTER 3 DECEMBER 1986 . IN SUPPORT OF THAT CONTENTION IT REFERS TO ARTICLE 7*(2)*C, SECOND SUBPARAGRAPH, OF DIRECTIVE 70/524, INSERTED BY COUNCIL DIRECTIVE 84/587 OF 29 NOVEMBER 1984 ( OFFICIAL JOURNAL 1984, L*319, P . 13 ). ACCORDING TO THAT PROVISION :
"THE LENGTH OF TIME FOR WHICH A NEW ADDITIVE OR NEW USE IS AUTHORIZED MUST NOT EXCEED FIVE YEARS FROM ITS BEING ENTERED IN THAT ANNEX ."
THE DEFENDANT ARGUES THAT, SINCE UNDER ARTICLE 2 OF DIRECTIVE 84/587 THAT PROVISION WAS TO BE IMPLEMENTED NO LATER THAN 3 DECEMBER 1986 AND SINCE CARBADOX HAD BEEN INCLUDED IN ANNEX II SINCE 1974 BY DIRECTIVE 74/378, ANY FURTHER INCLUSION OF THE ADDITIVE BEYOND THAT DATE WAS PROHIBITED BY ARTICLE 7*(2)*C, SECOND SUBPARAGRAPH .
23 AT THE HEARING THE COMMISSION WAS ASKED TO EXPLAIN HOW IT COULD CONSIDER CARBADOX TO BE A "NEW ADDITIVE" WITHIN THE MEANING OF ARTICLE 7*(2)*C, SECOND SUBPARAGRAPH, WHEN IT HAS BEEN INCLUDED IN ANNEX II SINCE 1 JANUARY 1975 AND ITS USE IN FEEDINGSTUFFS HAS BEEN AUTHORIZED ON THAT BASIS SINCE THAT DATE . THE COMMISSION STATED THAT THE TERM "NEW ADDITIVE" INCLUDED ALL ADDITIVES WHICH, LIKE CARBADOX, DID NOT APPEAR IN THE ORIGINAL ANNEXES TO DIRECTIVE 70/524 .
24 IT IS CLEAR FROM THE FOREGOING THAT THE APPLICANT IS CONFRONTED WITH A SITUATION IN WHICH CARBADOX APPEARS NEITHER IN ANNEX I NOR IN ANNEX II, IN SPITE OF THE FACT THAT THE COMMISSION PROPOSED TO THE COUNCIL ON 12 MARCH 1987 THAT CARBADOX BE INCLUDED IN ANNEX I ON THE GROUND THAT INVESTIGATIONS HAD PROVIDED SUFFICIENT EVIDENCE THAT ITS USE IN FEEDINGSTUFFS WAS NOT HARMFUL .
25 IT THEREFORE SEEMS ESSENTIAL, IN THE INTERESTS OF THE PROPER ADMINISTRATION OF JUSTICE, TO RESTORE THE STATUS QUO ANTE, WITHOUT PREJUDICE TO THE INTERPRETATION WHICH THE COURT WILL GIVE TO THE TERM "NEW ADDITIVE" IN ARTICLE 7*(2)*C, SECOND PARAGRAPH, WHEN IT CONSIDERS THE MAIN APPLICATION .
26 FOR THAT PURPOSE IT IS ESSENTIAL THAT MEASURES SHOULD BE TAKEN TO ENSURE THAT CARBADOX HAS THE STATUS OF A PRODUCT LISTED IN ANNEX II PENDING THE COMPLETION OF THE PROCEDURE FOR INCLUDING IT IN ANNEX I COMMENCED BY THE COMMISSION ON 12 MARCH 1987 OR PENDING THE COURT' S JUDGMENT ON THE MAIN APPLICATION .
ON THOSE GROUNDS,
THE PRESIDENT
BY WAY OF INTERIM DECISION,
HEREBY ORDERS AS FOLLOWS :
( 1 ) THE COMMISSION OF THE EUROPEAN COMMUNITIES SHALL :
WITHIN SEVEN DAYS OF THE SERVICE OF THIS ORDER, PROPOSE TO THE STANDING COMMITTEE FOR FEEDINGSTUFFS THAT THE SWINE GROWTH PROMOTER KNOWN AS CARBADOX, INVENTED, PRODUCED AND DISTRIBUTED BY PFIZER, SHOULD AGAIN BE INCLUDED IN ANNEX II OF COUNCIL DIRECTIVE 70/524 OF 23 NOVEMBER 1970;
INFORM, WITHIN THE SAME PERIOD, THE COMPETENT AUTHORITIES OF THE MEMBER STATES OF THE CONTENTS OF THIS ORDER .
( 2 ) COSTS ARE RESERVED .
LUXEMBOURG, 8 APRIL 1987 .
