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31971L0305

Council Directive 71/305/EEC of 26 July 1971 concerning the co-ordination of procedures for the award of public works contracts

Official Journal L 185 , 16/08/1971 P. 0005 - 0014 Danish special edition: Series I Chapter 1971(II) P. 0613  English special edition: Series I Chapter 1971(II) P. 0682  Greek special edition: Chapter 17 Volume 1 P. 0007  Spanish special edition: Chapter 17 Volume 3 P. 0009  Portuguese special edition Chapter 17 Volume 3 P. 0009

++++ ( 1 ) OJ N 2 , 15 . 1 . 1962 , P . 36/62 .   ( 2 ) OJ N 2 , 15 . 1 . 1962 , P . 32/62 .   ( 3 ) OJ N 62 , 13 . 4 . 1965 , P . 883/65 .   ( 4 ) OJ N 63 , 13 . 4 . 1965 , P . 929/65 .   ( 5 ) OJ N L 185 , 16 . 8 . 1971 , P . 1 .   ( 6 ) OJ N L 185 , 16 . 8 . 1971 , P . 15 .   ( 7 ) OJ N L 124 , 8 . 6 . 1971 , P . 1 .  COUNCIL DIRECTIVE  OF 26 JULY 1971  CONCERNING THE CO-ORDINATION OF PROCEDURES FOR THE AWARD OF PUBLIC WORKS CONTRACTS   ( 71/305/EEC )  THE COUNCIL OF THE EUROPEAN COMMUNITIES ,  HAVING REGARD TO THE TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY , AND IN PARTICULAR ARTICLES 57 ( 2 ) , 66 AND 100 THEREOF ;  HAVING REGARD TO THE GENERAL PROGRAMME FOR THE ABOLITION OF RESTRICTIONS ON FREEDOM OF ESTABLISHMENT , ( 1 ) AND IN PARTICULAR TITLE IV B 1 THEREOF ;  HAVING REGARD TO THE GENERAL PROGRAMME FOR THE ABOLITION OF RESTRICTIONS ON FREEDOM TO PROVIDE SERVICES , ( 2 ) AND IN PARTICULAR TITLE V C ( E ) 1 THEREOF ;  HAVING REGARD TO THE PROPOSAL FROM THE COMMISSION ;  HAVING REGARD TO THE OPINION OF THE EUROPEAN PARLIAMENT ( 3 ) ;  HAVING REGARD TO THE OPINION OF THE ECONOMIC AND SOCIAL COMMITTEE ( 4 ) ;  WHEREAS THE SIMULTANEOUS ATTAINMENT OF FREEDOM OF ESTABLISHMENT AND FREEDOM TO PROVIDE SERVICES IN RESPECT OF PUBLIC WORKS CONTRACTS AWARDED IN MEMBER STATES ON BEHALF OF THE STATE , OR REGIONAL OR LOCAL AUTHORITIES OR OTHER LEGAL PERSONS GOVERNED BY PUBLIC LAW ENTAILS NOT ONLY THE ABOLITION OF RESTRICTIONS BUT ALSO THE CO-ORDINATION OF NATIONAL PROCEDURES FOR THE AWARD OF PUBLIC WORKS CONTRACTS ;  WHEREAS SUCH CO-ORDINATION SHOULD TAKE INTO ACCOUNT AS FAR AS POSSIBLE THE PROCEDURES AND ADMINISTRATIVE PRACTICES IN FORCE IN EACH MEMBER STATE ;  WHEREAS THE COUNCIL , IN A STATEMENT CONCERNING THE AFOREMENTIONED GENERAL PROGRAMMES , HAS STRESSED THAT CO-ORDINATION SHOULD BE BASED ON THE FOLLOWING PRINCIPLES : PROHIBITION OF TECHNICAL SPECIFICATIONS THAT HAVE A DISCRIMINATORY EFFECT , ADEQUATE ADVERTISING OF CONTRACTS , THE FIXING OF OBJECTIVE CRITERIA FOR PARTICIPATION AND THE INTRODUCTION OF A PROCEDURE OF JOINT SUPERVISION TO ENSURE THE OBSERVATION OF THESE PRINCIPLES ;  WHEREAS SOME OF THE BODIES WHICH CURRENTLY ADMINISTER TRANSPORT SERVICES IN THE MEMBER STATES ARE GOVERNED BY PUBLIC LAW AND SOME BY PRIVATE LAW ; WHEREAS , IN ACCORDANCE WITH THE OBJECTIVES OF THE COMMON TRANSPORT POLICY , EQUALITY OF TREATMENT SHOULD BE ENSURED NOT ONLY BETWEEN SEPARATE UNDERTAKINGS CONCERNED WITH A SINGLE MODE OF TRANSPORT BUT ALSO BETWEEN SUCH UNDERTAKINGS AND UNDERTAKINGS CONCERNED WITH OTHER MODES OF TRANSPORT ;  WHEREAS , THEREFORE , PENDING THE ADOPTION OF PROVISIONS CONCERNING THE CO-ORDINATION OF PROCEDURES WHICH TAKE INTO ACCOUNT THE SPECIAL CIRCUMSTANCES DESCRIBED ABOVE , IT IS NECESSARY TO EXCLUDE FROM THE SCOPE OF THIS DIRECTIVE AUTHORITIES REFERRED TO ABOVE WHICH , BY REASON OF THEIR LEGAL STATUS , WOULD FALL WITHIN ITS SCOPE ;  WHEREAS IT IS NECESSARY TO AVOID THE SUBJECTION OF THE PRODUCTION , DISTRIBUTION AND TRANSMISSION OR TRANSPORTATION SERVICES FOR WATER AND ENERGY TO DIFFERENT SYSTEMS FOR THEIR WORKS CONTRACTS , DEPENDING ON WHETHER THEY COME UNDER THE STATE , REGIONAL OR LOCAL AUTHORITIES OR OTHER LEGAL PERSONS GOVERNED BY PUBLIC LAW OR WHETHER THEY HAVE SEPARATE LEGAL PERSONALITY ; WHEREAS IT IS THEREFORE NECESSARY TO EXCLUDE FROM THE SCOPE OF THIS DIRECTIVE THOSE SERVICES REFERRED TO ABOVE WHICH BY REASON OF THEIR LEGAL STATUS , WOULD FALL WITHIN ITS SCOPE UNTIL SUCH TIME AS A DEFINITIVE SOLUTION CAN BE ADOPTED IN THE LIGHT OF EXPERIENCE ;  WHEREAS PROVISION MUST BE MADE FOR EXCEPTIONAL CASES WHERE MEASURES CONCERNING THE CO-ORDINATION OF PROCEDURES MAY NOT NECESSARILY BE APPLIED , BUT SUCH CASES MUST BE EXPRESSLY LIMITED ;  WHEREAS WORKS CONTRACTS OF LESS THAN 1 000 000 UNITS OF ACCOUNT CAN , FOR THE MOMENT , BE EXEMPTED FROM COMPETITION AS PROVIDED FOR UNDER THIS DIRECTIVE , AND IT IS APPROPRIATE TO PROVIDE FOR THEIR EXEMPTION FROM CO-ORDINATION MEASURES ; WHEREAS , IN THE LIGHT OF EXPERIENCE , THE COMMISSION WILL AT A LATER DATE SUBMIT TO THE COUNCIL A NEW PROPOSAL FOR A DIRECTIVE WHOSE AIM IS TO LOWER THE THRESHOLD FOR THE APPLICATION OF CO-ORDINATION MEASURES TO PUBLIC WORKS CONTRACTS ;  WHEREAS TO ENSURE DEVELOPMENT OF EFFECTIVE COMPETITION IN THE FIELD OF PUBLIC CONTRACTS IT IS NECESSARY THAT CONTRACT NOTICES DRAWN UP BY THE AUTHORITIES OF MEMBER STATES AWARDING CONTRACTS BE ADVERTISED THROUGHOUT THE COMMUNITY ; WHEREAS THE INFORMATION CONTAINED IN THESE NOTICES MUST ENABLE CONTRACTORS ESTABLISHED IN THE COMMUNITY TO DETERMINE WHETHER THE PROPOSED CONTRACTS ARE OF INTEREST TO THEM ; WHEREAS , FOR THIS PURPOSE , IT IS APPROPRIATE TO GIVE THEM ADEQUATE INFORMATION ABOUT THE SERVICES TO BE PROVIDED AND THE CONDITIONS ATTACHED THERETO ; WHEREAS , MORE PARTICULARLY , IN RESTRICTED PROCEDURES ADVERTISEMENT IS INTENDED TO ENABLE CONTRACTORS OF MEMBER STATES TO EXPRESS THEIR INTEREST IN CONTRACTS BY SEEKING FROM THE AUTHORITIES AWARDING CONTRACTS INVITATIONS TO TENDER UNDER THE REQUIRED CONDITIONS ;  WHEREAS ADDITIONAL INFORMATION CONCERNING CONTRACTS MUST , AS IS CUSTOMARY IN MEMBER STATES , BE GIVEN IN THE CONTRACT DOCUMENTS FOR EACH CONTRACT OR ELSE IN AN EQUIVALENT DOCUMENT ;  HAS ADOPTED THIS DIRECTIVE :  TITLE I  GENERAL PROVISIONS  ARTICLE 1  FOR THE PURPOSES OF THIS DIRECTIVE :   ( A ) " PUBLIC WORKS CONTRACTS " ARE CONTRACTS FOR PECUNIARY CONSIDERATION CONCLUDED IN WRITING BETWEEN A CONTRACTOR ( A NATURAL OR LEGAL PERSON ) AND AN AUTHORITY AWARDING CONTRACTS AS DEFINED UNDER ( B ) , WHICH HAVE AS THEIR OBJECT ONE OF THE ACTIVITIES REFERRED TO IN ARTICLE 2 OF THE COUNCIL DIRECTIVE OF 26 JULY 1971 CONCERNING THE ABOLITION OF RESTRICTIONS ON FREEDOM TO PROVIDE SERVICES IN THE FIELD OF PUBLIC WORKS CONTRACTS AND ON THE AWARD OF PUBLIC WORKS CONTRACTS TO CONTRACTORS THROUGH ACTING AGENTS OR BRANCHES ( 5 ) ;   ( B ) THE STATE , REGIONAL OR LOCAL AUTHORITIES AND THE LEGAL PERSONS GOVERNED BY PUBLIC LAW SPECIFIED IN ANNEX I SHALL BE REGARDED AS " AUTHORITIES AWARDING CONTRACTS " ;   ( C ) A CONTRACTOR WHO HAS SUBMITTED A TENDER SHALL BE DESIGNATED BY THE TERM " TENDERER " , AND ONE WHO HAS SOUGHT AN INVITATION TO TAKE PART IN A RESTRICTED PROCEDURE BY THE TERM " CANDIDATE " .  ARTICLE 2  IN AWARDING PUBLIC WORKS CONTRACTS , THE AUTHORITIES AWARDING CONTRACTS SHALL APPLY THEIR NATIONAL PROCEDURES ADAPTED TO THE PROVISIONS OF THIS DIRECTIVE .  ARTICLE 3  1 . IN THE EVENT OF THE AUTHORITIES AWARDING CONTRACTS CONCLUDING A CONTRACT OF THE SAME TYPE AS THAT INDICATED IN ARTICLE 1 ( A ) EXCEPT FOR THE FACT THAT THE CONSIDERATION FOR THE WORKS TO BE CARRIED OUT CONSISTS EITHER SOLELY IN THE RIGHT TO EXPLOIT THE CONSTRUCTION OR IN THIS RIGHT TOGETHER WITH PAYMENT , THE PROVISIONS OF THIS DIRECTIVE SHALL NOT APPLY TO THIS SO CALLED " CONCESSION " CONTRACT . IN ALL OTHER CASES , APPLICATION OF THE PROCEDURES FOR THE AWARD OF PUBLIC CONTRACTS SHALL BE COMPULSORY .  2 . WHEN THE CONCESSIONAIRE IS HIMSELF ONE OF THE AUTHORITIES AWARDING CONTRACTS , HE MUST APPLY THE NATIONAL PROCEDURES FOR THE AWARD OF PUBLIC WORKS CONTRACTS ADAPTED TO THE PROVISIONS OF THIS DIRECTIVE FOR WORKS TO BE CARRIED OUT BY THIRD PARTIES .  3 . WHEN THE STATE , A REGIONAL OR LOCAL AUTHORITY OR ONE OF THE LEGAL PERSONS GOVERNED BY PUBLIC LAW SPECIFIED IN ANNEX I GRANTS TO A CONCESSIONAIRE OTHER THAN AN AUTHORITY AWARDING CONTRACTS THE RIGHT TO HAVE PUBLIC WORKS CARRIED OUT AND TO EXPLOIT THEM , THE CONCESSION CONTRACT SHALL STIPULATE THAT SUCH CONCESSIONAIRE MUST OBSERVE THE PRINCIPLE OF NON-DISCRIMINATION ON GROUNDS OF NATIONALITY IN RESPECT OF CONTRACTS AWARDED TO THIRD PARTIES .  4 . PUBLIC WORKS CONTRACTS AWARDED BY BODIES WHICH ARE GOVERNED BY PUBLIC LAW AND WHICH ADMINISTER TRANSPORT SERVICES SHALL NOT BE SUBJECT TO THE PROVISIONS OF THIS DIRECTIVE .  5 . THE PROVISIONS OF THIS DIRECTIVE SHALL NOT APPLY TO PUBLIC WORKS CONTRACTS AWARDED BY THE PRODUCTION , DISTRIBUTION , TRANSMISSION OR TRANSPORTATION SERVICES FOR WATER AND ENERGY .  ARTICLE 4  THIS DIRECTIVE SHALL NOT APPLY TO PUBLIC CONTRACTS AWARDED BY A MEMBER STATE :   _ IN PURSUANCE OF AN INTERNATIONAL AGREEMENT CONCLUDED WITH A THIRD COUNTRY WHICH , IN RESPECT OF THE AWARD OF CONTRACTS , CONTAINS PROVISIONS WHICH DIFFER FROM THOSE OF THIS DIRECTIVE ;   _ TO UNDERTAKINGS OF THIRD COUNTRIES IN PURSUANCE OF AN INTERNATIONAL AGREEMENT WHICH EXCLUDES UNDERTAKINGS OF MEMBER STATES ;   _ IN ACCORDANCE WITH THE PARTICULAR PROCEDURE OF AN INTERNATIONAL ORGANISATION .  ARTICLE 5  1 . NATIONAL PROCEDURES WHEREBY ANY INTERESTED CONTRACTOR MAY TENDER SHALL BE SUBJECT TO THE PROVISIONS RELATING TO " OPEN PROCEDURES " WITHIN THE MEANING OF THIS DIRECTIVE ( ARTICLES 10 TO 13 , 16 , 20 AND 23 TO 29 ) .  2 . NATIONAL PROCEDURES WHEREBY CONTRACTORS MAY TENDER ONLY IF INVITED TO DO SO BY THE AUTHORITIES AWARDING CONTRACTS SHALL BE SUBJECT TO THE PROVISIONS RELATING TO " RESTRICTED PROCEDURES " WITHIN THE MEANING OF THIS DIRECTIVE ( ARTICLES 10 TO 12 , 14 , 15 , 17 , 18 , 20 TO 29 ) .  3 . CONTRACTS AWARDED IN THE CASES REFERRED TO IN ARTICLE 9 SHALL BE SUBJECT TO THE PROVISIONS OF ARTICLE 10 ONLY .  ARTICLE 6  IN THE CASE OF CONTRACTS RELATING TO THE DESIGN AND CONSTRUCTION OF A PUBLIC HOUSING SCHEME WHOSE SIZE AND COMPLEXITY , AND THE ESTIMATED DURATION OF THE WORK INVOLVED , REQUIRE THAT PLANNING BE BASED FROM THE OUTSET ON CLOSE COLLABORATION WITHIN A TEAM COMPRISING REPRESENTATIVES OF THE AUTHORITIES AWARDING CONTRACTS , EXPERTS AND THE CONTRACTOR TO BE RESPONSIBLE FOR CARRYING OUT THE WORKS , A SPECIAL AWARD PROCEDURE MAY BE ADOPTED FOR SELECTING THE CONTRACTOR MOST SUITABLE FOR INTEGRATION INTO THE TEAM .  IN PARTICULAR , AUTHORITIES AWARDING CONTRACTS SHALL INCLUDE IN THE CONTRACT NOTICE AS ACCURATE AS POSSIBLE A DESCRIPTION OF THE WORKS TO BE CARRIED OUT SO AS TO ENABLE INTERESTED CONTRACTORS TO FORM A VALID IDEA OF THE PROJECT . FURTHERMORE , AUTHORITIES AWARDING CONTRACTS SHALL , IN ACCORDANCE WITH THE PROVISIONS OF ARTICLES 23 TO 28 , SET OUT IN SUCH CONTRACT NOTICE THE PERSONAL , TECHNICAL AND FINANCIAL CONDITIONS TO BE FULFILLED BY CANDIDATES .  WHERE SUCH PROCEDURE IS ADOPTED , AUTHORITIES AWARDING CONTRACTS SHALL APPLY THE COMMON ADVERTISING RULES RELATING TO RESTRICTED PROCEDURE AND TO THE CRITERIA FOR QUALITATIVE SELECTION .  ARTICLE 7  1 . THE PROVISIONS OF TITLES II , III AND IV AND ARTICLE 9 SHALL APPLY , UNDER THE CONDITIONS LAID DOWN IN ARTICLE 5 , TO PUBLIC WORKS CONTRACTS WHOSE ESTIMATED VALUE IS NOT LESS THAN 1 000 000 UNITS OF ACCOUNT .  2 . NO CONTRACT MAY BE SPLIT UP WITH THE INTENTION OF AVOIDING THE APPLICATION OF THIS ARTICLE .  ARTICLE 8  WHEN CALCULATING THE AMOUNTS REFERRED TO IN ARTICLES 7 , 9 AND 29 ACCOUNT SHALL BE TAKEN NOT ONLY OF THE AMOUNT OF THE WORKS CONTRACTS BUT ALSO OF THE ESTIMATED VALUE OF THE SUPPLIES NEEDED TO CARRY OUT THE WORKS WHICH ARE MADE AVAILABLE TO THE CONTRACTOR BY THE AUTHORITIES AWARDING CONTRACTS .  ARTICLE 9  AUTHORITIES AWARDING CONTRACTS MAY AWARD THEIR WORKS CONTRACTS WITHOUT APPLYING THE PROVISIONS OF THIS DIRECTIVE , EXCEPT THOSE OF ARTICLE 10 , IN THE FOLLOWING CASES :   ( A ) IN THE ABSENCE OF TENDERS , OR IN THE EVENT OF IRREGULAR TENDERS FOLLOWING ADOPTION OF ONE OF THE PROCEDURES LAID DOWN IN THIS DIRECTIVE , OR IN THE EVENT OF TENDERS WHICH ARE UNACCEPTABLE UNDER NATIONAL PROVISIONS THAT ARE IN ACCORDANCE WITH THE PROVISIONS OF TITLE IV , IN SO FAR AS THE TERMS OF THE ORIGINAL CONTRACT ARE NOT SUBSTANTIALLY ALTERED ;   ( B ) WHEN , FOR TECHNICAL OR ARTISTIC REASONS OR FOR REASONS CONNECTED WITH THE PROTECTION OF EXCLUSIVE RIGHTS , THE WORKS MAY ONLY BE CARRIED OUT BY A PARTICULAR CONTRACTOR ;   ( C ) FOR WORKS CARRIED OUT PURELY FOR PURPOSES OF RESEARCH , EXPERIMENT , STUDY OR DEVELOPMENT ;   ( D ) IN SO FAR AS IS STRICTLY NECESSARY WHEN , FOR REASONS OF EXTREME URGENCY BROUGHT BY EVENTS UNFORESEEN BY THE AUTHORITIES AWARDING CONTRACTS , THE TIME LIMIT LAID DOWN IN OTHER PROCEDURES CANNOT BE KEPT ;   ( E ) WHEN WORKS ARE DECLARED SECRET OR WHEN THEIR EXECUTION MUST BE ACCOMPANIED BY SPECIAL SECURITY MEASURES IN ACCORDANCE WITH THE PROVISIONS LAID DOWN BY LAW , REGULATION OR ADMINISTRATIVE ACTION IN FORCE IN THE MEMBER STATE CONCERNED , OR WHEN THE PROTECTION OF THE BASIC INTERESTS OF THAT STATE'S SECURITY SO REQUIRES ;   ( F ) FOR ADDITIONAL WORKS NOT INCLUDED IN THE CONTRACT ORIGINALLY CONSIDERED OR IN THE CONTRACT FIRST CONCLUDED BUT WHICH HAVE , THROUGH UNFORESEEN CIRCUMSTANCES , BECOME NECESSARY FOR CARRYING OUT THE WORK DESCRIBED THEREIN , ON CONDITION THAT THE AWARD IS MADE TO THE CONTRACTOR CARRYING OUT SUCH WORK ;   _ WHEN SUCH WORKS CANNOT BE TECHNICALLY OR FINANCIALLY SEPARATED FROM THE MAIN CONTRACT WITHOUT GREAT INCONVENIENCE TO THE AUTHORITIES AWARDING CONTRACTS ;   _ OR WHEN SUCH WORKS , ALTHOUGH SEPARABLE FROM THE EXECUTION OF THE ORIGINAL CONTRACT , ARE STRICTLY NECESSARY TO ITS LATER STAGES ;  HOWEVER , THE AGGREGATE VALUE OF CONTRACTS AWARDED FOR ADDITIONAL WORKS MAY NOT EXCEED 50 % OF THE VALUE OF THE ORIGINAL CONTRACT ;   ( G ) FOR NEW WORKS CONSISTING OF THE REPETITION OF SIMILAR WORKS ENTRUSTED TO THE UNDERTAKING TO WHICH THE SAME AUTHORITIES AWARDING CONTRACTS AWARDED AN EARLIER CONTRACT , PROVIDED THAT SUCH WORKS CONFORM TO A BASIC PROJECT FOR WHICH A FIRST CONTRACT WAS AWARDED ACCORDING TO THE PROCEDURES REFERRED TO IN ARTICLE 5 ;  AS SOON AS THE FIRST PROJECT IS PUT UP FOR TENDER , NOTICE MUST BE GIVEN THAT THIS PROCEDURE MIGHT BE ADOPTED AND THE TOTAL ESTIMATED COST OF SUBSEQUENT WORKS SHALL BE TAKEN INTO CONSIDERATION BY THE AUTHORITIES AWARDING CONTRACTS WHEN THEY APPLY THE PROVISIONS OF ARTICLE 5 . THIS PROCEDURE MAY ONLY BE APPLIED DURING THE THREE YEARS FOLLOWING THE CONCLUSION OF THE ORIGINAL CONTRACT ;   ( H ) IN EXCEPTIONAL CASES , WHEN THE NATURE OF THE WORKS OR RISKS ATTACHED THERETO DO NOT PERMIT PRIOR OVERALL PRICING .  BEFORE THE END OF JUNE OF EACH YEAR , MEMBER STATES SHALL SEND THE COMMISSION A STATEMENT OF THE NUMBER AND TOTAL VALUE OF CONTRACTS AWARDED IN THE PRECEDING YEAR ON THE BASIS OF THE PRESENT ARTICLE , AT LEAST AS REGARDS CONTRACTS AWARDED BY STATES , LAENDER , REGIONS , PROVINCES OR DEPARTMENTS . MEMBER STATES SHALL , AS FAR AS POSSIBLE , CLASSIFY THE CONTRACTS AWARDED ACCORDING TO EACH OF THE CASES CITED IN THIS ARTICLE .  TITLE II  COMMON RULES IN THE TECHNICAL FIELD  ARTICLE 10  1 . THE TECHNICAL SPECIFICATIONS DEFINED IN ANNEX II AND THE DESCRIPTION OF TESTING , CHECKING , ACCEPTANCE AND CALCULATION METHODS SHALL FIGURE IN THE GENERAL DOCUMENTS OR IN THE CONTRACTUAL DOCUMENTS RELATING TO EACH CONTRACT . SUCH TECHNICAL SPECIFICATIONS MAY BE DEFINED BY REFERENCE TO NATIONAL STANDARDS .  2 . UNLESS SUCH SPECIFICATIONS ARE JUSTIFIED BY THE SUBJECT OF THE CONTRACT , MEMBER STATES SHALL PROHIBIT THE INTRODUCTION INTO THE CONTRACTUAL CLAUSES RELATING TO A GIVEN CONTRACT OF TECHNICAL SPECIFICATIONS WHICH MENTION PRODUCTS OF A SPECIFIC MAKE OR SOURCE OR OF A PARTICULAR PROCESS AND WHICH THEREFORE FAVOUR OR ELIMINATE CERTAIN UNDERTAKINGS . IN PARTICULAR , THE INDICATION OF TRADE MARKS , PATENTS , TYPES , OR OF A SPECIFIC ORIGIN OR PRODUCTION , SHALL BE PROHIBITED . HOWEVER , IF SUCH INDICATION IS ACCOMPANIED BY THE WORDS " OR EQUIVALENT " , IT SHALL BE AUTHORISED IN CASES WHERE THE AUTHORITIES AWARDING CONTRACTS ARE UNABLE TO GIVE A DESCRIPTION OF THE SUBJECT OF THE CONTRACT USING SPECIFICATIONS WHICH ARE SUFFICIENTLY PRECISE AND INTELLIGIBLE TO ALL PARTIES CONCERNED .  ARTICLE 11  WHEN PROJECTS ARE PUT UP FOR COMPETITION OR WHEN INVITATIONS TO TENDER PERMIT CONTRACTORS TO SUBMIT VARIATIONS ON A PROJECT OF THE ADMINISTRATION , THE AUTHORITIES AWARDING CONTRACTS MAY NOT REJECT A TENDER SOLELY ON THE GROUNDS THAT IT HAS BEEN DRAWN UP USING A METHOD FOR PRICING THE WORKS WHICH DIFFERS FORM THAT USED IN THE COUNTRY WHERE THE CONTRACT IS BEING AWARDED , PROVIDED THAT THE TENDER ACCORDS WITH THE TERMS AND CONDITIONS OF THE CONTRACT DOCUMENTS . THE TENDERER MUST INCLUDE WITH HIS TENDER ALL THE EVIDENCE NEEDED FOR EXAMINING THE PROJECT AND MUST SUPPLY ANY ADDITIONAL EXPLANATIONS WHICH THE AUTHORITIES AWARDING CONTRACTS CONSIDER NECESSARY .  TITLE III  COMMON ADVERTISING RULES  ARTICLE 12  AUTHORITIES AWARDING CONTRACTS WHO WISH TO AWARD A PUBLIC WORKS CONTRACT BY OPEN OR RESTRICTED PROCEDURE SHALL MAKE KNOWN THEIR INTENTION BY MEANS OF A NOTICE .  SUCH NOTICE SHALL BE SENT TO THE OFFICIAL PUBLICATIONS OFFICE OF THE EUROPEAN COMMUNITIES AND SHALL BE PUBLISHED IN FULL IN THE OFFICIAL JOURNAL OF THE EUROPEAN COMMUNITIES IN THE OFFICIAL LANGUAGES OF THE COMMUNITIES , THE ORIGINAL TEXT ALONE BEING AUTHENTIC .  UNDER THE ACCELERATED PROCEDURE PROVIDED FOR IN ARTICLE 15 ,THE NOTICE SHALL BE PUBLISHED IN ITS ORIGINAL LANGUAGE ONLY , IN THE FOUR EDITIONS OF THE OFFICIAL JOURNAL OF THE EUROPEAN COMMUNITIES .  THE NOTICE REFERRED TO IN THE PRECEDING PARAGRAPH SHALL BE PUBLISHED IN THE OFFICIAL JOURNAL OF THE EUROPEAN COMMUNITIES NOT LATER THAN NINE DAYS AFTER THE DATE OF DISPATCH AND , IN THE CASE OF THE ACCELERATED PROCEDURE PROVIDED FOR IN ARTICLE 15 , NOT LATER THAN FIVE DAYS AFTER THAT DATE .  THE NOTICE SHALL NOT BE PUBLISHED IN THE OFFICIAL JOURNALS OR IN THE SPECIALIST PRESS OF THE COUNTRY OF THE AUTHORITIES AWARDING CONTRACTS BEFORE THE DATE OF ITS DISPATCH , AND IT SHALL MENTION THIS DATE . IT SHALL NOT CONTAIN INFORMATION OTHER THAN THAT PUBLISHED IN THE OFFICIAL JOURNAL OF THE EUROPEAN COMMUNITIES .  THE AUTHORITIES AWARDING CONTRACTS MUST BE ABLE TO SUPPLY EVIDENCE OF THE DATE OF DISPATCH .  ARTICLE 13  IN OPEN PROCEDURES , THE TIME LIMIT FOR THE RECEIPT OF TENDERS SHALL BE FIXED BY THE AUTHORITIES AWARDING CONTRACTS AT NO LESS THAN THIRTY-SIX DAYS FROM THE DATE OF SENDING THE NOTICE . PROVIDED IT HAS BEEN REQUESTED IN GOOD TIME , ADDITIONAL INFORMATION RELATING TO THE CONTRACT DOCUMENTS SHALL BE SUPPLIED BY THE AUTHORITIES AWARDING CONTRACTS NOT LATER THAN SIX DAYS BEFORE THE FINAL DATE FIXED FOR RECEIPT OF TENDERS .  WHERE TENDERS CAN ONLY BE MADE AFTER A VISIT TO THE SITE OR AFTER INSPECTION OF THE DOCUMENTS SUPPORTING THE CONTRACT DOCUMENTS , THE TIME LIMITS LAID DOWN IN THE PRECEDING PARAGRAPH SHALL BE EXTENDED ACCORDINGLY .  ARTICLE 14  IN RESTRICTED PROCEDURES , THE TIME LIMIT FOR RECEIPT OF REQUESTS TO PARTICIPATE SHALL BE FIXED BY THE AUTHORITIES AWARDING CONTRACTS AT NOT LESS THAN TWENTY ONE DAYS FROM THE DATE OF SENDING THE NOTICE .  THE AUTHORITIES AWARDING CONTRACTS SHALL SIMULTANEOUSLY AND IN WRITING INVITE THE SELECTED CANDIDATES TO SUBMIT THEIR TENDERS .  THE TIME LIMIT FOR THE RECEIPT OF TENDERS SHALL BE FIXED BY THE AUTHORITIES AWARDING CONTRACTS AT NOT LESS THAN TWENTY-ONE DAYS FROM THE DATE OF SENDING THE WRITTEN INVITATION . PROVIDED IT HAS BEEN REQUESTED IN GOOD TIME , ADDITIONAL INFORMATION RELATING TO THE CONTRACT DOCUMENTS MUST BE SUPPLIED BY THE AUTHORITIES AWARDING CONTRACTS AT LEAST SIX DAYS BEFORE THE FINAL DATE FIXED FOR RECEIPT OF TENDERS .  WHEN TENDERS CAN ONLY BE MADE AFTER A VISIT TO THE SITE OR AFTER INSPECTION OF THE DOCUMENTS SUPPORTING THE CONTRACT DOCUMENTS , THE TIME LIMITS LAID DOWN IN THE PRECEDING PARAGRAPH SHALL BE EXTENDED ACCORDINGLY .  ARTICLE 15  IN CASES WHERE URGENCY TENDERS IMPRACTICABLE THE TIME LIMITS LAID DOWN IN THE PRECEDING ARTICLE , THE AUTHORITIES AWARDING CONTRACTS MAY APPLY THE SHORTER TIME LIMITS SPECIFIED BELOW :   _ A TIME LIMIT FOR THE RECEIPT OF REQUESTS TO PARTICIPATE WHICH SHALL BE NOT LESS THAN TWELVE DAYS FROM THE DATE OF SENDING THE NOTICE ;   _ A TIME LIMIT FOR THE RECEIPT OF TENDERS WHICH SHALL BE NOT LESS THAN TEN DAYS FROM THE DATE OF THE INVITATION TO TENDER .  PROVIDED IT HAS BEEN REQUESTED IN GOOD TIME , ADDITIONAL INFORMATION RELATING TO THE CONTRACT DOCUMENTS MUST BE SUPPLIED BY THE AUTHORITIES AWARDING CONTRACTS NOT LATER THAN FOUR DAYS BEFORE THE FINAL DATE FIXED FOR THE RECEIPT OF TENDERS .  REQUESTS FOR PARTICIPATION IN CONTRACTS AND INVITATIONS TO TENDER MAY BE MADE IN WRITING OR BY TELEGRAM , TELEX OR TELEPHONE . WHEN REQUESTS TO PARTICIPATE ARE MADE BY TELEGRAM , TELEX OR TELEPHONE , THEY MUST BE CONFIRMED IN WRITING .  ARTICLE 16  IN OPEN PROCEDURES , THE NOTICE SHALL INCLUDE AT LEAST THE FOLLOWING INFORMATION :   ( A ) THE DATE OF DISPATCH TO THE OFFICIAL PUBLICATIONS OFFICE OF THE EUROPEAN COMMUNITIES ;   ( B ) THE AWARD PROCEDURE CHOSEN ;   ( C ) THE SITE ; THE NATURE AND EXTENT OF THE SERVICES TO BE PROVIDED AND THE GENERAL NATURE OF THE WORK ; IF THE CONTRACT IS SUBDIVIDED INTO SEVERAL LOTS : THE ORDER OF SIZE OF THE DIFFERENT LOTS AND THE POSSIBILITY OF TENDERING FOR ONE , FOR SEVERAL , OR FOR ALL OF THE LOTS ; IF THE NOTICE CONCERNS A CONTRACT WHICH , APART FROM THE POSSIBLE CARRYING OUT OF WORKS , ENTAILS THE DRAWING UP OF A PROJECT , THEN ONLY THE INFORMATION NEEDED BY CONTRACTORS TO UNDERSTAND THE PURPOSE OF THE CONTRACT AND TO TENDER ACCORDINGLY ;   ( D ) ANY TIME LIMIT FOR THE COMPLETION OF THE WORKS ;   ( E ) THE ADDRESS OF THE SERVICE AWARDING THE CONTRACT ;   ( F ) THE ADDRESS OF THE SERVICE FROM WHICH THE CONTRACT DOCUMENTS AND ADDITIONAL DOCUMENTS MAY BE REQUESTED AND THE FINAL DATE FOR MAKING SUCH A REQUEST ; ALSO THE AMOUNT AND TERMS OF PAYMENT OF ANY SUM FOR SUCH DOCUMENTS ;   ( G ) THE FINAL DATE FOR RECEIPT OF TENDERS , THE ADDRESS TO WHICH THEY MUST BE SENT AND THE LANGUAGE OR LANGUAGES IN WHICH THEY MUST BE DRAWN UP ;   ( H ) THE PERSONS AUTHORISED TO BE PRESENT AT THE OPENING OF TENDERS AND THE DATE , TIME AND PLACE OF THIS OPENING ;   ( I ) INFORMATION ABOUT DEPOSITS AND ANY OTHER GUARANTEES , WHATEVER THEIR FORM , WHICH MAY BE REQUIRED BY THE AUTHORITIES AWARDING CONTRACTS ;   ( J ) THE MAIN TERMS CONCERNING FINANCING AND PAYMENT AND / OR REFERENCES TO THE PROVISIONS LAID DOWN BY LAW OR REGULATION IN WHICH THESE ARE CONTAINED ;   ( K ) THE SPECIFIC LEGAL FORM WHICH WILL , IF NECESSARY , BE ASSUMED BY THE GROUP OF CONTRACTORS TO WHOM THE CONTRACT IS AWARDED ;   ( L ) THE MINIMUM ECONOMIC AND TECHNICAL STANDARDS WHICH THE AUTHORITIES AWARDING CONTRACTS REQUIRE OF CONTRACTORS FOR THEIR SELECTION ; THESE REQUIREMENTS MAY NOT BE OTHER THAN THOSE SPECIFIED IN ARTICLES 25 AND 26 ;   ( M ) THE PERIOD DURING WHICH TENDERERS SHALL BE BOUND TO KEEP OPEN THEIR TENDERS .  ARTICLE 17  IN RESTRICTED PROCEDURES , THE NOTICE SHALL INCLUDE AT LEAST THE FOLLOWING INFORMATION :   ( A ) THE INFORMATION GIVEN IN ARTICLE 16 ( A ) , ( B ) , ( C ) , ( D ) , ( E ) AND ( K ) ;   ( B ) THE FINAL DATE FOR RECEIPT OF REQUESTS TO PARTICIPATE , THE ADDRESS TO WHICH THEY MUST BE SENT AND THE LANGUAGE OR LANGUAGES IN WHICH THEY MUST BE WRITTEN ;   ( C ) THE FINAL DATE FOR WHICH INVITATIONS TO TENDER SHALL BE ISSUED BY THE SERVICE AWARDING THE CONTRACT ;   ( D ) THE INFORMATION TO BE GIVEN IN THE REQUEST TO PARTICIPATE , IN THE FORM OF STATEMENTS WHICH CAN LATER BE CHECKED CONCERNING THE CONTRACTOR'S PERSONAL POSITION AND THE MINIMUM ECONOMIC AND TECHNICAL STANDARDS WHICH THE AUTHORITIES AWARDING CONTRACTS REQUIRE OF CONTRACTORS FOR THEIR SELECTION ; THESE REQUIREMENTS MAY NOT BE OTHER THAN THOSE SPECIFIED IN ARTICLES 25 AND 26 .  ARTICLE 18  AN INVITATION TO TENDER UNDER RESTRICTED PROCEDURES SHALL INCLUDE AT LEAST THE FOLLOWING INFORMATION :   ( A ) THE INFORMATION GIVEN IN ARTICLE 16 ( F ) , ( G ) , ( I ) AND ( J ) ;   ( B ) A REFERENCE TO THE NOTICE MENTIONED IN ARTICLE 17 ;   ( C ) AN INDICATION OF ANY DOCUMENTS TO BE ANNEXED , EITHER TO SUPPORT THE VERIFIABLE STATEMENTS FURNISHED BY THE CANDIDATE IN ACCORDANCE WITH ARTICLE 17 ( D ) , OR TO SUPPLEMENT THE INFORMATION PROVIDED FOR IN THAT ARTICLE UNDER THE SAME CONDITIONS AS THOSE LAID DOWN IN ARTICLES 25 AND 26 ;   ( D ) THE CRITERIA FOR THE AWARD OF THE CONTRACT IF THESE ARE NOT GIVEN IN THE NOTICE .  ARTICLE 19  THE AUTHORITIES AWARDING CONTRACTS MAY PUBLISH IN THE OFFICIAL JOURNAL OF THE EUROPEAN COMMUNITIES NOTICES OF PUBLIC WORKS CONTRACTS WHICH ARE NOT SUBJECT TO THE COMPULSORY ADVERTISING MEASURES PROVIDED FOR IN THIS DIRECTIVE , WHERE THE VALUE OF SUCH CONTRACT IS NOT LESS THAN 500 000 UNITS OF ACCOUNT .  TITLE IV  COMMON RULES ON PARTICIPATION  ARTICLE 20  CONTRACTS SHALL BE AWARDED ON THE BASIS OF THE CRITERIA LAID DOWN IN CHAPTER 2 OF THIS TITLE , AFTER THE SUITABILITY OF CONTRACTORS NOT EXCLUDED UNDER THE PROVISIONS OF ARTICLE 23 HAS BEEN CHECKED BY THE AUTHORITIES AWARDING CONTRACTS IN ACCORDANCE WITH THE CRITERIA OF ECONOMIC AND FINANCIAL STANDING AND OF TECHNICAL KNOWLEDGE OR ABILITY REFERRED TO IN ARTICLES 25 TO 28 .  ARTICLE 21  TENDERS MAY BE SUBMITTED BY GROUPS OF CONTRACTORS . THESE GROUPS MAY NOT BE REQUIRED TO ASSUME A SPECIFIC LEGAL FORM IN ORDER TO SUBMIT THE TENDER ; HOWEVER , THE GROUP SELECTED MAY BE REQUIRED TO DO SO WHEN IT HAS BEEN AWARDED THE CONTRACT .  ARTICLE 22  IN RESTRICTED PROCEDURES , WITHIN THE MEANING OF ARTICLE 5 ( 2 ) , THE AUTHORITIES AWARDING CONTRACTS SHALL ON THE BASIS OF THE INFORMATION GIVEN IN ACCORDANCE WITH THE PROVISIONS OF ARTICLE 17 ( D ) SELECT WHICH CANDIDATES THEY SHALL INVITE TO TENDER .  EACH MEMBER STATE SHALL ENSURE THAT AUTHORITIES AWARDING CONTRACTS ISSUE INVITATIONS TO THOSE NATIONALS OF OTHER MEMBER STATES WHO SATISFY THE NECESSARY REQUIREMENTS , UNDER THE SAME CONDITIONS AS TO ITS OWN NATIONALS .  CHAPTER I  CRITERIA FOR QUALITATIVE SELECTION  ARTICLE 23  ANY CONTRACTOR MAY BE EXCLUDED FROM PARTICIPATION IN THE CONTRACT WHO :   ( A ) IS BANKRUPT OR IS BEING WOUND UP , WHOSE AFFAIRS ARE BEING ADMINISTERED BY THE COURT , WHO HAS ENTERED INTO AN ARRANGEMENT WITH CREDITORS , WHO HAS SUSPENDED BUSINESS ACTIVITIES OR WHO IS IN ANY ANALOGOUS SITUATION ARISING FROM A SIMILAR PROCEDURE UNDER NATIONAL LAWS AND REGULATIONS ;   ( B ) IS THE SUBJECT OF PROCEEDINGS FOR A DECLARATION OF BANKRUPTCY , FOR AN ORDER FOR COMPULSORY WINDING UP OR ADMINISTRATION BY THE COURT OR FOR AN ARRANGEMENT WITH CREDITORS OR OF ANY OTHER SIMILAR PROCEEDINGS UNDER NATIONAL LAWS OR REGULATIONS ;   ( C ) HAS BEEN CONVICTED OF AN OFFENCE CONCERNING HIS PROFESSIONAL CONDUCT BY A JUDGMENT WHICH HAS THE FORCE OF RES JUDICATA ;   ( D ) WHO HAS BEEN GUILTY OF GRAVE PROFESSIONAL MISCONDUCT PROVEN BY ANY MEANS WHICH THE AUTHORITIES AWARDING CONTRACTS CAN JUSTIFY ;   ( E ) HAS NOT FULFILLED OBLIGATIONS RELATING TO THE PAYMENT OF SOCIAL SECURITY CONTRIBUTIONS IN ACCORDANCE WITH THE LEGAL PROVISIONS OF THE COUNTRY IN WHICH HE IS ESTABLISHED OR WITH THOSE OF THE COUNTRY OF THE AUTHORITY AWARDING CONTRACTS ;   ( F ) HAS NOT FULFILLED OBLIGATIONS RELATING TO THE PAYMENT OF TAXES IN ACCORDANCE WITH THE LEGAL PROVISIONS OF THE COUNTRY OF THE AUTHORITY AWARDING CONTRACTS ;   ( G ) IS GUILTY OF SERIOUS MISREPRESENTATION IN SUPPLYING THE INFORMATION REQUIRED UNDER THIS CHAPTER .  WHERE THE AUTHORITY AWARDING CONTRACTS REQUIRES OF THE CONTRACTOR PROOF THAT NONE OF THE CASES QUOTED IN ( A ) , ( B ) , ( C ) , ( E ) OR ( F ) APPLIES TO HIM , IT SHALL ACCEPT AS SUFFICIENT EVIDENCE :   _ FOR ( A ) , ( B ) OR ( C ) , THE PRODUCTION OF AN EXTRACT FROM THE " JUDICIAL RECORD " OR , FAILING THIS , OF AN EQUIVALENT DOCUMENT ISSUED BY A COMPETENT JUDICIAL OR ADMINISTRATIVE AUTHORITY IN THE COUNTRY OF ORIGIN OR IN THE COUNTRY WHENCE THAT PERSON COMES SHOWING THAT THESE REQUIREMENTS HAVE BEEN MET ;   _ FOR ( E ) OR ( F ) , A CERTIFICATE ISSUED BY THE COMPETENT AUTHORITY IN THE MEMBER STATE CONCERNED .  WHERE THE COUNTRY CONCERNED DOES NOT ISSUE SUCH DOCUMENTS OR CERTIFICATES , THEY MAY BE REPLACED BY A DECLARATION ON OATH MADE BY THE PERSON CONCERNED BEFORE A JUDICIAL OR ADMINISTRATIVE AUTHORITY , A NOTARY OR A COMPETENT PROFESSIONAL OR TRADE BODY , IN THE COUNTRY OF ORIGIN OR IN THE COUNTRY WHENCE THAT PERSON COMES .  MEMBER STATES SHALL , WITHIN THE TIME LIMIT LAID DOWN IN ARTICLE 32 , DESIGNATE THE AUTHORITIES AND BODIES COMPETENT TO ISSUE THESE DOCUMENTS AND SHALL FORTHWITH INFORM THE OTHER MEMBER STATES AND THE COMMISSION THEREOF .  ARTICLE 24  ANY CONTRACTOR WISHING TO TAKE PART IN A PUBLIC WORKS CONTRACT MAY BE REQUESTED TO PROVE HIS ENROLMENT IN THE PROFESSIONAL OR TRADE REGISTER UNDER THE CONDITIONS LAID DOWN BY THE LAWS OF THE COMMUNITY COUNTRY IN WHICH HE IS ESTABLISHED : IN BELGIUM , THE REGISTRE DU COMMERCE _ HANDELSREGISTER ; IN GERMANY , THE HANDELSREGISTER AND THE HANDWERKSROLLE ; IN FRANCE , THE REGISTRE DU COMMERCE AND THE REPERTOIRE DES METIERS ; IN ITALY , THE REGISTRO DELLA CAMERA DI COMMERCIO , INDUSTRIA , AGRICOLTURA E ARTIGIANATO AND THE REGISTRO DELLE COMMISSIONI PROVINCIALI PER L'ARTIGIANATO ; IN LUXEMBOURG , THE REGISTRE AUX FIRMES AND THE ROLE DE LA CHAMBRE DES METIERS ; IN THE NETHERLANDS , THE HANDELSREGISTER .  ARTICLE 25  PROOF OF THE CONTRACTOR'S FINANCIAL AND ECONOMIC STANDING MAY , AS A GENERAL RULE , BE FURNISHED BY ONE OR MORE OF THE FOLLOWING REFERENCES :   ( A ) APPROPRIATE STATEMENTS FROM BANKERS ;   ( B ) THE PRESENTATION OF THE FIRM'S BALANCE SHEETS OR EXTRACTS FROM THE BALANCE SHEETS , WHERE PUBLICATION OF THE BALANCE SHEET IS REQUIRED UNDER COMPANY LAW IN THE COUNTRY IN WHICH THE CONTRACTOR IS ESTABLISHED ;   ( C ) A STATEMENT OF THE FIRM'S OVERALL TURNOVER AND THE TURNOVER ON CONSTRUCTION WORKS FOR THE THREE PREVIOUS FINANCIAL YEARS .  THE AUTHORITIES AWARDING CONTRACTS SHALL SPECIFY IN THE NOTICE OR IN THE INVITATION TO TENDER WHICH REFERENCE OR REFERENCES THEY HAVE CHOSEN AND WHAT REFERENCES OTHER THAN THOSE MENTIONED UNDER ( A ) , ( B ) OR ( C ) ARE TO BE PRODUCED .  IF , FOR ANY VALID REASON , THE CONTRACTOR IS UNABLE TO SUPPLY THE REFERENCES REQUESTED BY THE AUTHORITIES AWARDING CONTRACTS , HE MAY PROVE HIS ECONOMIC AND FINANCIAL STANDING BY ANY OTHER DOCUMENT WHICH THE AUTHORITIES AWARDING CONTRACTS CONSIDER APPROPRIATE .  ARTICLE 26  PROOF OF THE CONTRACTOR'S TECHNICAL KNOWLEDGE OR ABILITY MAY BE FURNISHED BY :   ( A ) THE CONTRACTOR'S EDUCATIONAL AND PROFESSIONAL QUALIFICATIONS AND / OR THOSE OF THE FIRM'S MANAGERIAL STAFF , AND , IN PARTICULAR , THOSE OF THE PERSON OR PERSONS RESPONSIBLE FOR CARRYING OUT THE WORKS ;   ( B ) A LIST OF THE WORKS CARRIED OUT OVER THE PAST FIVE YEARS , ACCOMPANIED BY CERTIFICATES OF SATISFACTORY EXECUTION FOR THE MOST IMPORTANT WORKS . THESE CERTIFICATES SHALL INDICATE THE VALUE , DATE AND SITE OF THE WORKS AND SHALL SPECIFY WHETHER THEY WERE CARRIED OUT ACCORDING TO THE RULES OF THE TRADE AND PROPERLY COMPLETED . WHERE NECESSARY , THE COMPETENT AUTHORITY SHALL SUBMIT THESE CERTIFICATES TO THE AUTHORITY AWARDING CONTRACTS DIRECT ;   ( C ) A STATEMENT OF THE TOOLS , PLANT AND TECHNICAL EQUIPMENT AVAILABLE TO THE CONTRACTOR FOR CARRYING OUT THE WORK ;   ( D ) A STATEMENT OF THE FIRM'S AVERAGE ANNUAL MANPOWER AND THE NUMBER OF MANAGERIAL STAFF FOR THE LAST THREE YEARS ;   ( E ) A STATEMENT OF THE TECHNICIANS OR TECHNICAL DIVISIONS WHICH THE CONTRACTOR CAN CALL UPON FOR CARRYING OUT THE WORK , WHETHER OR NOT THEY BELONG TO THE FIRM .  THE AUTHORITIES AWARDING CONTRACTS SHALL SPECIFY IN THE NOTICE OR IN THE INVITATION TO TENDER WHICH OF THESE REFERENCES ARE TO BE PRODUCED .  ARTICLE 27  THE AUTHORITY AWARDING CONTRACTS MAY , WITHIN THE LIMITS OF ARTICLES 23 TO 26 , INVITE THE CONTRACTOR TO SUPPLEMENT THE CERTIFICATES AND DOCUMENTS SUBMITTED OR TO CLARIFY THEM .  ARTICLE 28  1 . MEMBER STATES WHO HAVE OFFICIAL LISTS OF RECOGNISED CONTRACTORS MUST , WHEN THIS DIRECTIVE ENTERS INTO FORCE , ADAPT THEM TO THE PROVISIONS OF ARTICLE 23 ( A ) TO ( D ) AND ( G ) AND OF ARTICLES 24 TO 26 .  2 . CONTRACTORS REGISTERED IN THESE LISTS MAY , FOR EACH CONTRACT , SUBMIT TO THE AUTHORITY AWARDING CONTRACTS A CERTIFICATE OF REGISTRATION ISSUED BY THE COMPETENT AUTHORITY . THIS CERTIFICATE SHALL STATE THE REFERENCES WHICH ENABLED THEM TO BE REGISTERED IN THE LIST AND THE CLASSIFICATION GIVEN IN THIS LIST .  3 . CERTIFIED REGISTRATION IN SUCH LISTS BY THE COMPETENT BODIES SHALL , FOR THE AUTHORITIES OF OTHER MEMBER STATES AWARDING CONTRACTS , CONSTITUTE A PRESUMPTION OF SUITABILITY FOR WORKS CORRESPONDING TO THE CONTRACTOR'S CLASSIFICATION ONLY AS REGARDS ARTICLES 23 ( A ) TO ( D ) AND ( G ) , 24 , 25 ( B ) AND ( C ) AND 26 ( B ) AND ( D ) AND NOT AS REGARDS ARTICLES 25 ( A ) AND 26 ( A ) , ( C ) AND ( E ) .  INFORMATION WHICH CAN BE DEDUCED FROM REGISTRATION IN OFFICIAL LISTS MAY NOT BE QUESTIONED . HOWEVER , WITH REGARD TO THE PAYMENT OF SOCIAL SECURITY CONTRIBUTIONS , AN ADDITIONAL CERTIFICATE MAY BE REQUIRED OF ANY REGISTERED CONTRACTOR WHENEVER A CONTRACT IS OFFERED .  THE AUTHORITIES OF OTHER MEMBER STATES AWARDING CONTRACTS SHALL APPLY THE ABOVE PROVISIONS ONLY IN FAVOUR OF CONTRACTORS WHO ARE ESTABLISHED IN THE COUNTRY HOLDING THE OFFICIAL LIST .  4 . FOR THE REGISTRATION OF CONTRACTORS OF OTHER MEMBER STATES IN SUCH A LIST , NO FURTHER PROOFS AND STATEMENTS MAY BE REQUIRED OTHER THAN THOSE REQUESTED OF NATIONALS AND , IN ANY EVENT , ONLY THOSE PROVIDED FOR UNDER ARTICLES 23 TO 26 .  5 . MEMBER STATES HOLDING AN OFFICIAL LIST SHALL COMMUNICATE TO OTHER MEMBER STATES THE ADDRESS OF THE BODY TO WHICH REQUESTS FOR REGISTRATION MAY BE MADE .  CHAPTER II  CRITERIA FOR THE AWARD OF CONTRACTS  1 . THE CRITERIA ON WHICH THE AUTHORITIES AWARDING CONTRACTS SHALL BASE THE AWARD OF CONTRACTS SHALL BE :   _ EITHER THE LOWEST PRICE ONLY ;   _ OR , WHEN THE AWARD IS MADE TO THE MOST ECONOMICALLY ADVANTAGEOUS TENDER , VARIOUS CRITERIA ACCORDING TO THE CONTRACT : E.G . PRICE , PERIOD FOR COMPLETION , RUNNING COSTS , PROFITABILITY , TECHNICAL MERIT .  2 . IN THE LATTER INSTANCE , THE AUTHORITIES AWARDING CONTRACTS SHALL STATE IN THE CONTRACT DOCUMENTS OR IN THE CONTRACT NOTICE ALL THE CRITERIA THEY INTEND TO APPLY TO THE AWARD , WHERE POSSIBLE IN DESCENDING ORDER OF IMPORTANCE .  3 . THE PRICE CRITERION AS CALCULATED IN ACCORDANCE WITH CURRENT NATIONAL REGULATIONS ( ITALIAN " ANONYMOUS ENVELOPE " PROCEDURE ) MAY BE RETAINED FOR A PERIOD OF THREE YEARS FOLLOWING EXPIRY OF THE TIME LIMIT LAID DOWN IN ARTICLE 32 FOR CONTRACTS WHOSE ESTIMATED VALUE DOES NOT EXCEED 10 000 000 UNITS OF ACCOUNT , AND FOR SEVEN YEARS FROM THE SAME DATE FOR CONTRACTS WHOSE ESTIMATED VALUE IS BETWEEN 1 000 000 AND 2 000 000 UNITS OF ACCOUNT .  4 . THE PROVISIONS OF PARAGRAPH 1 SHALL NOT APPLY WHEN A MEMBER STATE BASES THE AWARD OF CONTRACTS ON OTHER CRITERIA , WITHIN THE FRAMEWORK OF RULES WHOSE AIM IS TO GIVE PREFERENCE TO CERTAIN TENDERERS BY WAY OF AID , ON CONDITION THAT THE RULES INVOKED ARE IN CONFORMITY WITH THE TREATY , IN PARTICULAR ARTICLES 92 ET SEQ .  5 . IF , FOR A GIVEN CONTRACT , TENDERS ARE OBVIOUSLY ABNORMALLY LOW IN RELATION TO THE TRANSACTION , THE AUTHORITY AWARDING CONTRACTS SHALL EXAMINE THE DETAILS OF THE TENDERS BEFORE DECIDING TO WHOM IT WILL AWARD THE CONTRACT . THE RESULT OF THIS EXAMINATION SHALL BE TAKEN INTO ACCOUNT .  FOR THIS PURPOSE IT SHALL REQUEST THE TENDERER TO FURNISH THE NECESSARY EXPLANATIONS AND , WHERE APPROPRIATE , IT SHALL INDICATE WHICH PARTS IT FINDS UNACCEPTABLE .  IF THE DOCUMENTS RELATING TO THE CONTRACT PROVIDE FOR ITS AWARD AT THE LOWEST PRICE TENDERED , THE AUTHORITY AWARDING CONTRACTS MUST JUSTIFY TO THE ADVISORY COMMITTEE SET UP BY THE COUNCIL DECISION OF 26 JULY 1971 ( 6 ) THE REJECTION OF TENDERS WHICH IT CONSIDERS TO BE TOO LOW .  TITLE V  FINAL PROVISIONS  ARTICLE 30  THE CALCULATION OF THE TIME LIMIT FOR RECEIPT OF TENDERS OR REQUESTS TO PARTICIPATE SHALL BE MADE IN ACCORDANCE WITH COUNCIL REGULATION ( EEC , EURATOM ) N 1182/71 OF 3 JUNE 1971 DETERMINING THE RULES APPLICABLE TO PERIODS , DATES AND TIME LIMITS ( 7 ) .  ARTICLE 31  THE COST OF PUBLICATION IN THE OFFICIAL JOURNAL OF THE EUROPEAN COMMUNITIES OF THE NOTICES PROVIDED FOR UNDER ARTICLES 12 AND 19 SHALL BE DEFRAYED BY THE COMMUNITIES IN ACCORDANCE WITH THE PROCEDURE AND CONDITIONS PUBLISHED IN THE OFFICIAL JOURNAL .  ARTICLE 32  MEMBER STATES SHALL ADOPT THE MEASURES NECESSARY TO COMPLY WITH THIS DIRECTIVE WITHIN TWELVE MONTHS OF ITS NOTIFICATION AND SHALL FORTHWITH INFORM THE COMMISSION THEREOF .  ARTICLE 33  MEMBER STATES SHALL ENSURE THAT THE TEXT OF THE MAIN PROVISIONS OF NATIONAL LAW WHICH THEY ADOPT IN THE FIELD COVERED BY THIS DIRECTIVE IS COMMUNICATED TO THE COMMISSION .  ARTICLE 34  THIS DIRECTIVE IS ADDRESSED TO THE MEMBER STATES .  DONE AT BRUSSELS , 26 JULY 1971 .  FOR THE COUNCIL  THE PRESIDENT  A . MORO  ANNEX I  LIST OF CORPORATE BODIES GOVERNED BY PUBLIC LAW REFERRED TO IN ARTICLE 1 ( B )  I . IN ALL MEMBER STATES :  ASSOCIATIONS GOVERNED BY PUBLIC LAW FORMED BY REGIONAL OR LOCAL AUTHORITIES , E.G . , ASSOCIATIONS DE COMMUNES , SYNDICATS DE COMMUNES , GEMEINDEVERBAENDE ETC .  II . IN BELGIUM :   _ LE FONDS DES ROUTES _ HET WEGENFONDS   _ LA REGIE DES VOIES AERIENNES _ DE REGIE DER LUCHTWEGEN   _ PUBLIC ASSISTANCE COMMISSIONS   _ STRUCTURES OF THE CHURCH   _ L'OFFICE REGULATEUR DE LA NAVIGATION INTERIEURE _ DE DIENST VOOR REGELING VAN DE BINNENVAART   _ LA REGIE DES SERVICES FRIGORIFIQUES DE L'ETAT BELGE _ DE REGIE DER BELGISCHE RIJKSKOEL EN VRIESDIENSTEN  III . IN GERMANY :  THE BUNDESUNMITTELBARE KOERPERSCHAFTEN , ANSTALTEN UND STIFTUNGEN DES OEFFENTLICHEN RECHTS  IV . IN FRANCE :  OTHER ADMINISTRATIVE PUBLIC BODIES AT NATIONAL , DEPARTMENTAL AND LOCAL LEVELS  V . IN ITALY :   _ STATE UNIVERSITIES , STATE UNIVERSITY INSTITUTES , CONSORTIA FOR UNIVERSITY DEVELOPMENT WORKS ,   _ HIGHER SCIENTIFIC AND CULTURAL INSTITUTES , ASTRONOMICAL , ASTROPHYSICAL , GEOPHYSICAL AND VULCANOLOGICAL OBSERVATORIES   _ THE ENTI DI RIFORMA FONDIARIA   _ RELIEF AND CHARITY ORGANISATIONS  VI . IN LUXEMBOURG :   _ SOCIAL INSURANCE OFFICES   _ OTHER PUBLIC ADMINISTRATIVE BODIES  VII . IN THE NETHERLANDS :   _ THE WATERSCHAPPEN   _ THE RIJKSUNIVERSITEITEN , THE ACADEMISCHE ZIEKENHUIZEN , THE GEMEENTELIJKE UNIVERSITEIT VAN AMSTERDAM , THE ROOMS-KATHOLIEKE UNIVERSITEIT VAN NIJMEGEN , THE VRIJE UNIVERSITEIT VAN AMSTERDAM , THE TECHNISCHE HOGESCHOLEN  THE NEDERLANDSE CENTRALE ORGANISATIE VOOR TOEGEPASTE NATUURWETENSCHAPPELIJK ONDERZOEK ( TNO ) AND ITS DEPENDENT ORGANISATIONS  ANNEX II  TECHNICAL SPECIFICATIONS WITHIN THE MEANING OF THIS DIRECTIVE  WITHIN THE MEANING OF THIS DIRECTIVE , TECHNICAL SPECIFICATIONS IN THE FIELD OF PUBLIC WORKS CONTRACTS SHALL COMPRISE ALL THE TECHNICAL REQUIREMENTS GIVEN IN THE CONTRACT DOCUMENTS WHICH PERMIT AN OBJECTIVE DESCRIPTION OF A JOB , MATERIAL , PRODUCT OR SUPPLY ( ESPECIALLY QUALITY , PERFORMANCE ) SO THAT THAT JOB , MATERIAL , PRODUCT OR SUPPLY FULFILS THE PURPOSE FOR WHICH IT IS REQUIRED BY THE AUTHORITY AWARDING CONTRACTS .  THESE TECHNICAL SPECIFICATIONS SHALL INCLUDE ALL THE MECHANICAL , PHYSICAL AND CHEMICAL PROPERTIES , THE CLASSIFICATIONS AND STANDARDS , AND THE TEST , CHECKING , AND ACCEPTANCE CONDITIONS FOR WORKS AND FOR THE MATERIALS AND PARTS WHICH THEY INVOLVE . THEY SHALL ALSO INCLUDE METHODS OR TECHNIQUES OF CONSTRUCTION AND ALL THE OTHER TECHNICAL CONDITIONS WHICH THE AUTHORITY AWARDING CONTRACTS IS IN A POSITION TO PRESCRIBE , UNDER GENERAL OR SPECIFIC REGULATIONS , IN RELATION TO THE FINISHED WORKS AND TO THE MATERIALS OR PARTS WHICH THEY INVOLVE .


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31984L0539

Council Directive 84/539/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to electro-medical equipment used in human or veterinary medicine

Official Journal L 300 , 19/11/1984 P. 0179 - 0187 Finnish special edition: Chapter 13 Volume 14 P. 0131  Spanish special edition: Chapter 13 Volume 18 P. 0133  Swedish special edition: Chapter 13 Volume 14 P. 0131  Portuguese special edition Chapter 13 Volume 18 P. 0133

COUNCIL DIRECTIVE of 17 September 1984 on the approximation of the laws of the Member States relating to electro-medical equipment used in human or veterinary medicine (84/539/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas, in each Member State, electro-medical equipment used in human or veterinary medicine must meet a high and clearly-defined degree of safety both for the users of such equipment and for those receiving treatment by means of the equipment;  Whereas several Member States have sought to ensure that degree of safety by mandatory specifications relating both to the technical safety regulations and the inspection procedures ; whereas those specifications differ from one Member State to another;  Whereas these obstacles to the establishment and operation of the common market can be reduced or even eliminated if the same specifications are adopted by all the Member States, either in addition to or in place of their present legislation;  Whereas it is advisable in the first instance to harmonize at Community level one section of the equipment in question ; whereas the most adequate form of harmonization is by reference to the standards drawn up by the European Committee for Electrotechnical Standardization (Cenelec);  Whereas, in order to ensure that the equipment complies with the harmonized standards, the manufacturer acknowledges his responsibility by a mark or declaration of conformity;  Whereas technical progress requires prompt adaptation of the technical specifications laid down by the Directives with respect to electro-medical equipment ; whereas, in order to facilitate the implementation of the measures required, provision should be made for a procedure establishing dose cooperation between the Member States and the Commission within the Committee on the Adaptation to Technical Progress of the Directives for Removing Technical Barriers to Trade in Electro-medical Equipment;  Whereas electro-medical equipment, although conforming to the requirements of this Directive, might endanger public safety and health ; whereas a procedure should therefore be laid down to obviate this risk,  HAS ADOPTED THIS DIRECTIVE:    Article 1 This Directive shall apply to the electro-medical equipment listed in Annex II (hereinafter called "equipment") which is intended, by its nature, for use in human or veterinary medicine.   Article 2 1. Member States may not, on grounds of safety relating to its manufacture, refuse, prohibit or restrict the sale, free movement or use for its intended purpose of the equipment referred to in Article 1 of this Directive where it conforms with the requirements of this Directive.  Annex I contains the technical requirements to which the equipment must conform.  (1) OJ No C 33, 12.2.1975, p. 5. (2) OJ No C 76, 14.3.1975, p. 37. (3) OJ No C 233, 17.11.1975, p. 39.   2. The conformity of equipment to the requirements of this Directive shall be attested by the manufacturer or by the importer, under the latter's responsibility, by the affixing of a mark which conforms to the specimen shown in Annex III or by a declaration which conforms to the specimen shown in Annex IV.   Article 3 Member States shall ensure that the services provided with the help of equipment meeting the requirements of this Directive are reimbursed on the same terms as the services provided with the help of equipment meeting the criteria required under the provisions in force within their territory- as regards the authorized applications and minimum requirements for the equipment.   Article 4 The following shall be adopted in accordance with the procedure laid down in Article 6:    - any amendments to Annex I made necessary by the adaptation to technical progress of the harmonized standards by the relevant standards organization,       - any amendments to Annex I which are desirable because of adaptation to technical progress where the relevant standards organization has not made the corresponding amendments to the harmonized standard.         In the latter case, the amendments shall be notified to the competent standards organization.   Article 5 1. A Committee on the Adaptation to Technical Progress of the Directives for Removing Technical Barriers to Trade in Electro-medical Equipment (hereinafter called "the Committee") is hereby set up ; it shall consist of representatives of the Member States and shall be chaired by a Commission representative.  2. The Committee shall draw up its own rules of procedure.   Article 6 1. Where reference is made to the procedure laid down in this Article, the matter shall be referred to the Committee by its chairman, either on his own initiative or at the request of a representative of a Member State.  2. The Commission representative shall submit to the Committee a draft of the measures to be taken. The Committee shall give its opinion on that draft within a time limit set by the chairman having regard to the urgency of the matter. Opinions shall be delivered by a majority of 45 votes, the votes of the Member States being weighted as provided for in Article 148 (2) of the Treaty. The chairman shall not vote.  3.    (a) Where the proposed measures are in accordance with the opinion of the Committee the Commission shall adopt them.       (b) Where the proposed measures are not in accordance with the opinion of the Committee or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal on the measures to be taken. The Council shall act by a qualified majority.       (c) If, within three months of the proposal being submitted to it, the Council has not acted, the proposed measures shall be adopted by the Commission.          Article 7 1. If a Member State determines, on the basis of a substantiated justification, that one or more appliances, although complying with the requirements of this Directive, represent a hazard to safety, it may provisionally prohibit the sale, free movement or use of the appliance or appliances on its territory or make it subject to special conditions. It shall immediately inform the other Member States and the Commission thereof, stating the grounds for its decision.  2. The Commission shall, within six weeks, consult the Member States concerned, following which it shall deliver its opinion without delay and take the appropriate steps.  3. If the Commission is of the opinion that technical adaptations to the Directive are necessary, such adaptations shall be adopted by either the Commission or the Council in accordance with the procedure laid down in Article 6. In that case, the Member State which has adopted the safeguard measures may maintain them until the entry into force of the adaptations.   Article 8 1. Member States shall take all appropriate measures to ensure that the marks and declaration of conformity referred to in Article 2 are issued by the manufacturer  or the importer only under the conditions laid down in the Directive.  2. Member States shall make all necessary arrangements to ensure adequate surveillance of the manufacture of the equipment.   Article 9 Member States shall take all appropriate measures to prevent the use on equipment of marks or markings which might be confused with the EEC mark described in Annex III.   Article 10 1. Member States shall bring into force the measures necessary to comply with this Directive within 24 months of its notification and shall forthwith inform the Commission thereof (1).  2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive.   Article 11 This Directive is addressed to the Member States.     Done at Brussels, 17 September 1984.  For the Council  The President  P. BARRY  (1) This Directive was notified to the Member States on 26 September 1984.     ANNEX I The technical requirements to which the equipment referred to in Article 1 must conform are the following:  Harmonization document of the European Committee for Electrotechnical Standardization (Cenelec) HD 395-1 : General Requirements (1979 edition - document based on IEC No 601-1 of the International Electrotechnical Commission) ; this standard being applicable subject to the following amendments:  In the case of the equipment referred to in 2.2.1.1 of Annex II, the requirements of HD 395-1 are amended as follows:  Sub-clause 14.6 (b) : The equipment shall be minimally of type BF;  Sub-clause 19.3 : Patient Auxiliary Current:  Normal condition - 1 mA  Single fault condition - 5 mA.    ANNEX II  LIST OF EQUIPMENT REFERRED TO IN ARTICLE 1    1. DIAGNOSTIC EQUIPMENT  (excluding equipment subject to defibrillator discharge protection)      1.1. Equipment for the procurement of information from a living being without the influence of an external source.        1.1.1. Equipment for the procurement of biopotentials.          1. Equipment and corresponding accessories for diagnostic or monitoring purposes to study or monitor electrical activity or electrical characteristics of living beings:            - electroencephalographs and electrocorticographs,                       - electromyographs,                       - electroretinographs,                       - electronystagmographs.                                          2. Equipment and corresponding accessories.                                  1.1.2. Equipment for the procurement of other parameters.          1. Equipment and corresponding accessories to study the infra-red radiation produced by living organisms for diagnostic purposes:            - thermoscanners,                       - thermographs,                       - radiation thermometers.                                          2. Equipment and corresponding accessories to study acoustic activity or sensitivity of living beings:            - electronic stethoscopes,                       - phonocardioscopes and phonocardiographs only where not intended for cardiovascular interventions,                       - audiometers,                       - audiophones.                                          3. Equipment and corresponding accessories:            - ballistocardiographs,                       - electronic thermometers only where intended for cardiovascular interventions.                                                                    1.2. Equipment for the procurement of information from a living being under the influence of an external source.        1.2.1. Equipment using an electronic source.  Equipment and corresponding accessories which apply directly electrical currents to living organisms:          - equipment for the measurement of skin resistance,                   - equipment for pulmonary or vascular impedance rheography.                                   1.2.2. Equipment using another source.          1. Equipment and corresponding accessories for ophthalmological diagnosis:            - equipment for illumination of the eye : slit lamps, eye mirrors, spectral light sources, ophthalmoscopes,                       - equipment for viewing, imaging and measurement of the eye : ophthalmometers, refractometers, tonometers, photometers, retinoscopes, cornea-microscopes,                       - ophthalmological diagnostic units consisting of ophthalmological equipment as mentioned above combined with necessary auxiliary devices : stands, columns, chairs.                                          2. Equipment and corresponding accessories intended to support visibility by monocular or binocular enlargement for diagnostic purposes and to be used for viewing surgical procedures (excluding high-frequency surgical equipment):            - surgical microscopes,                       - colposcopes,                       - otoscopes,                       - dermatoscopes.                                          3. Equipment and corresponding accessories intended for local illumination of areas to be examined or treated:            - head-lamps,                       - illuminated head-mirrors,                       - fluorescent hand-lamps,                       - mouth-lamps.                                                                           2. THERAPEUTIC EQUIPMENT      2.1. Specific therapeutic equipment.        2.1.1. Equipment using electric energy.  1. Equipment and corresponding accessories which produce electrically charged or ionized air, vapours or mists ; charging or ionization may be achieved by:          - high voltage,                   - electron emission from hot metal.                                  2.1.2. Equipment applying other forms of energy.          1. Equipment and corresponding accessories which produce certain mechanical effects in medicine:            - vibrators,                       - equipment for pressurized water-massage,                       - equipment for extracorporal cardiac massage.                                          2. Equipment and corresponding accessories which produce hot air, steam or vapours for medical therapeutic purposes:            - equipment in which solid or liquid material is evaporated by heating or mechanical means for inhalation purposes,                       - hot-air baths.                         This section does not include ultrasonic equipment.                                              2.2. Electro-surgical equipment.        2.2.1. Equipment using electric energy.  1. Equipment and corresponding accessories using low-frequency electric energy to produce heat for electrocautery:          - equipment for electrocautery,                   - parts of combined medical electrical equipment intended for electrocautery.                                  2.2.2. Equipment using other forms of energy.          1. Equipment and corresponding accessories for ophthalmological therapeutic purposes:            - equipment for treatment of the eye,                       - eye magnets.                                          2. Equipment and corresponding accessories.                   3. Equipment and corresponding accessories which produce certain mechanical effects in medicine:            - drilling, sawing and polishing equipment for dentistry or surgery,                       - water-driven equipment.                                                                    2.3. Equipment for the support or replacement of body functions  (excluding implanted cardiac stimulators and other implanted devices).        2.3.1. Equipment for support or replacement by other means.          1. Equipment and corresponding accessories intended to support or replace certain body functions:            - artificial limbs,                       - aids for the paralyzed,                       - artificial speech equipment.                                          2. Equipment and corresponding accessories intended to assist human sensors:  - aids for the blind.                                                    3. OTHER EQUIPMENT  Equipment and accessories for handling and positioning of the patient for surgical or dental purposes:      - operating tables,           - operating chairs,           - operating units,           - dental chairs,           - dental units.                     ANNEX III  SPECIMEN MARK OF CONFORMITY AFFIXED BY THE MANUFACTURER >PIC FILE= "T0026447">     ANNEX IV SPECIMEN DECLARATION OF CONFORMITY   Application of Council Directive 84/539/EEC of 17 September 1984 >PIC FILE= "T0026448">


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31989L0662

Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market

Official Journal L 395 , 30/12/1989 P. 0013 - 0022 Finnish special edition: Chapter 3 Volume 31 P. 0216  Swedish special edition: Chapter 3 Volume 31 P. 0216

COUNCIL DIRECTIVE of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market (89/662/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas the Community is to adopt measures designed to establish the internal market progressively over a period expiring on 31 December 1992;  Whereas the harmonious operation of the common organization of the market in livestock products and products of animal origin implies the dismantling of veterinary barriers to the development of intra-Community trade in the products concerned; whereas  in this respect the free movement of agricultural products is a fundamental feature of the common organization of markets and should facilitate the rational development of agricultural production and the optimum use of the factors of production.  Whereas in the veterinary field frontiers are currently being used for carrying out checks aimed at safeguarding public health and animal health;   Whereas the ultimate aim is to ensure that veterinary checks are carried out at the place of dispatch only; whereas the attainment of this objective implies the harmonization of the basic requirements relating to the safeguarding of public health and  animal health;  Whereas with a view to the completion of the internal market, pending the attainment of this objective, the emphasis should be placed on the checks to be carried out at the place of dispatch and in organizing those that could be carried out at the place  of destination; whereas such a solution would entail the suspension of veterinary checks at the Community's internal frontiers;  Whereas this solution implies increased confidence in the veterinary checks carried out by the State of dispatch; whereas the latter must ensure that such veterinary checks are carried out in an appropriate manner;  Whereas in the State of destination spot veterinary checks could be carried out at the place of destination; whereas, however, in the event of a serious presumption of irregularity, the veterinary check could be carried out while the goods are in  transit;  Whereas it is for the Member States to specify in a plan to be submitted the manner in which they intend to carry out the checks and whereas these plans should be the subject of Community approval;  Whereas provision must be made for the action to be taken where a veterinary check discloses that the consignment is irregular; whereas in such a situation three possible solutions may be singled out: the aim of the first would be to provide for the  regularization of incorrect documents, that of the second to avert any danger where it is found that there has been an outbreak of an epizootic disease, any new serious and contagious disease or other cause likely to constitute a serious hazard to animals or to human health, while the third would arise where the goods do not satisfy the requirements laid down for reasons other than those referred to above;  Whereas provision should be made for a procedure for resolving conflicts which could arise concerning consignments from an establishment, production centre or undertaking;  Whereas provision must be made for protective measures; whereas in this area, especially for reasons of effectiveness, responsibility must rest firstly with the Member State of dispatch; whereas the Commission must be able to act speedily, in particular  by way of on-the-spot visits and adopting measures appropriate to the situation.  Whereas in order to be effective, the rules laid down by this Directive must cover all goods that are subject in the case of intra-Community trade to veterinary requirements;  Whereas, however, with regard to certain epizootic diseases, different health situations still prevail in the Member States and whereas, pending a Community approach on the methods to combat these diseases, the question of checking intra-Community trade  in livestock should for the time being be left to one side and a documentary check should be permitted during transport; whereas, in view of the current state of harmonization and pending Community rules, goods that are not the subject of harmonized  rules should comply with the requirements of the State of destination provided that the latter are in conformity with Article 36 of the Treaty;  Whereas the provisions of existing Directives should be adapted to the new rules laid down in this Directive;  Whereas these rules should be re-examined before the end of 1993;  Whereas the Commission should be entrusted with the task of adopting measures for applying this Directive; whereas, to that end, provision should be made for procedures establishing close and effective cooperation between the Commission and the Member  States within the Standing Veterinary Committee,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Member States shall ensure that the veterinary checks to be carried out on products of animal origin which are covered by the Directives listed in Annex A or by Article 14 and which are intended for trade are no longer carried out, without  prejudice to Article 6, at frontiers but are carried out in accordance with this Directive.  Article 2 For the purposes of this Directive:  1.  'Veterinary check' means any physical check and/or administrative formality which applies to the products referred to in Article 1 and which is intended for the protection, direct or otherwise, of public or animal health;  2.  'trade' means trade between Member States in goods within the meaning of Article 9 (2) of the Treaty;  3.  'establishment' means any undertaking which produces, stores or processes the products referred to in Article 1;  4.  'competent authority' means the central authority of a Member State competent to carry out veterinary checks or any authority to which it has delegated that competence;  5.  'official veterinarian' means the veterinarian appointed by the competent central authority of the Member State.   CHAPTER I Checks at origin Article 3 1.  Member States shall ensure that the only products intended for trade are those referred to in Article 1 which have been obtained, checked, marked and labelled in accordance with Community rules for the destination in question and which are  accompanied to the final consignee mentioned therein by a health certificate, animal-health certificate or by any other document provided for by Community veterinary rules.  The establishments of origin shall ensure, by constant self-supervision, that such products satisfy the requirements of the first subparagraph.  Without prejudice to the monitoring duties assigned to the official veterinarian under Community legislation, the competent authority shall carry out regular checks on establishments in order to satisfy itself that products intended for trade comply  with Community requirements or, in the cases referred to in paragraph 3 of this Article and Article 14, with the requirements of the Member State of destination.  Where there are grounds for suspecting that requirements are not being met, the competent authority shall carry out the necessary checks and, if the suspicion is confirmed, take the appropriate measures, which may include withdrawing approval.  2.  Where the transport operation involves several places of destination, products must be grouped together in as many batches as there are places of destination. Each batch must be accompanied by the aforementioned certificate or document.  Where the products referred to in Article 1 are intended for export to a third country, the transport operation must remain under customs supervision up to the point of exit from Community territory.  3.  Member States which make optional imports from certain third countries shall inform the Commission and the other Member States of the existence of such imports.  Where products are brought into Community territory by a Member State other than those referred to above, that Member State shall carry out a documentary check on the origin and destination of the goods in accordance with Article 6 (1).  Member States of destination shall prohibit the products concerned from being sent on from their territory unless they are bound for another Member State using the same option.  Article 4 1.  Member States of dispatch shall take the necessary measures to ensure that operators comply with veterinary requirements at all stages of the production, storage, marketing and transport of the products referred to in Article 1. In  particular, they shall ensure that:  - the products obtained in accordance with the directives referred to in Annex A are checked in the same way, from a veterinary viewpoint, whether they are intended for intra-Community trade or for the national market,  - the products covered by Annex B are not dispatched to the territory of another Member State, if they cannot be marketed on their own territory for reasons justified by Article 36 of the Treaty.  2.  Member States of dispatch shall take the appropriate administrative, legal or penal measures to penalize any infringement of veterinary legislation by natural or legal persons where it is found that Community rules have been infringed, in particular  where it is found that the certificates or documents drawn up do not correspond to the actual state of the products or that public health stamps have been affixed to products which do not comply with those rules.   CHAPTER II Checks on arrival at the destination Article 5 1.  Member States of destination shall implement the following measures:  (a)  The competent authority may, at the places of destination of goods, check by means of non-discriminatory veterinary spot-checks that the requirements of Article 3 have been complied with; it may take samples at the same time.  Furthermore, where the competent authority of the Member State of transit or of the Member State of destination has information leading it to suspect an infringement, checks may also be carried out during the transport of goods in its territory,  including checks on compliance as regards the means of transport;  (b)  where the products referred to in Article 1 originating in another Member State are intended:  - for an establishment placed under the responsibility of an official veterinarian, the latter must ensure that only products that meet the requirements of Article 3 (1) with respect to marking and accompanying documents or, in the case of the products  referred to in Annex B, are accompanied by the document stipulated by the rules of the country of destination, are admitted to that establishment,  - for an approved intermediary who divides up the batches or for a commercial undertaking with many branches, or any establishment not subject to permanent supervision, the latter must check, before the batch is divided up or marketed, that the said  marks, certificate, or documents referred to in the first indent are present and notify the competent authority of any irregularity or anomaly,  - for other consignees, particularly where the batch is partially unloaded during transport, the batch must be accompanied, in accordance with Article 3 (1), by the original of the certificate referred to in the first indent.  The guarantees which must be furnished by the consignees referred to in the second and third indents shall be specified in an agreement with the competent authority to be signed at the time of the prior registration provided for in paragraph 3. The  competent authority shall carry out random checks to verify compliance with those guarantees.  2.  Without prejudice to Article 4, where the Community standards laid down by Community rules have not been set and in the case provided for in Article 14, the Member State of destination may require, with due regard for the general provisions of the  Treaty, that the establishment of origin must apply the standards in force under the national rules of that Member State. The Member State of origin shall ensure that the product in question comply with those requirements.  3.  Operators who have products delivered to them from another Member State or who completely divide up a batch of such products:  (a)  shall be subject, if so requested by the competent authority, to prior registration;  (b)  shall keep a register in which such deliveries are recorded;  (c)  must, if so requested by the competent authority, report the arrival of products from another Member State, to the extent necessary to carry out the checks referred to in paragraph 1;  (d)  keep for a period of not less than six months to be specified by the competent authority, the health certificates or documents referred to in Article 3 for presentation to the competent authority should the latter so request.  4.  The detailed rules for implementing this Article shall be adopted in accordance with the procedure laid down in Article 18.  5.  The Council, acting on the basis of a Commission report accompanied by any proposals for amendments, shall re-examine this Article within a period of three years from the implementation of this Directive.  Article 6 1.  Member States shall ensure that during the checks carried out at the places where products from a third country may be brought into Community territory, such as ports, airports and frontier posts with third countries, the following  measures are taken:  (a)  a documentary check is made on the products' origin;  (b)  where products are imported from third countries, they must be sent, under customs supervision, to inspection posts in order that veterinary checks may be carried out.  The products referred to in Annex A may not be given customs clearance unless those checks have shown that they comply with Community rules.  The products referred to in Annex B and those which are the subject of optional imports in accordance with Article 3 (3) which, after having been brought into Community territory, are to be sent to the territory of another Member State, must:  - either undergo veterinary checks to show that they comply with the rules of the Member State of destination,  - or, after a solely visual check to establish that the documents and the products tally, be sent under customs supervision to the place of destination where veterinary checks must be carried out;  (c)  products of Community origin shall be subject to the rules of inspection laid down in Article 5.  2.  However, as from 1 January 1993 and by way of derogation from paragraph 1, all products transported by regular, direct means of transport linking two geographical points of the Community shall be subject to the rules of inspection laid down in  Article 5.  Article 7 1.  If, during a check carried out at the place of destination of a consignment or during transport, the competent authorities of a Member State establish:  (a)  the presence of agents responsible for a disease named in Directive 82/894/EEC (4), as last amended by Commission Decision 89/162/EEC (5), a zoonosis or disease, or any cause likely to constitute a serious hazard to animals or humans, or that the  products come from an area infected by an epizootic disease, they shall, except as regards animal-health aspects, in the case of products subject to one of the treatments referred to in Article 4 of Directive 80/215/EEC (6), as last amended by Directive  88/660/EEC (7), order the batch to be destroyed or used in any other way laid down by Community rules.  Costs relating to the destruction of the batch shall be borne by the consignor or his representative.  The competent authorities of the Member State of destination shall immediately notify the competent authorities of the other Member States and the Commission by telex of the findings arrived at, the decisions taken and the reasons for such decisions.  The protective measures provided for in Article 9 may be applied.  In addition, at the request of a Member State and in accordance with the procedure laid down in Article 17, the Commission may, in order to deal with situations not provided for by Community legislaton, adopt any measure necessary to arrive at a  concerted approach by the Member States;  (b)  that the goods do not meet the conditions laid down by Community directives, or, in the absence of decisions on the Community standards provided for by the directives, by national standards, they may, provided that health and animal-health  considerations so permit, give the consignor or his representative the choice of:  - destroying the goods, or - using the goods for other purposes, including returning them with the authorization of the competent authority of the country of the establishment of origin.   b)  - However, if the certificate or the documents are found to contain irregularities, the consignor must be granted a period of grace before recourse is had to this last possibility.  2.  In accordance with the procedure laid down in Article 18, the Commission shall draw up a list of the agents and diseases referred to in paragraph 1, and detailed rules for the application of this Article.  Article 8 1.  In the cases provided for in Article 7, the competent authority of the Member State of destination shall contact the competent authorities of the Member State of dispatch without delay. The latter authorities shall take all necessary  measures and notify the competent authority of the first Member State of the nature of the checks carried out, the decisions taken and the reasons for such decisions.  If the authority of the first Member State fears that such measures are inadequate, the competent authorities of the two Member States shall together seek ways and means of remedying the situation; if appropriate this may involve an on-the-spot  inspection.  Where the checks provided for in Article 7 show repeated irregularities, the competent authority of the Member State of destination shall inform the Commission and the veterinary departments of the other Member States.  The Commission, at the request of the competent authority of the Member State of destination or on its own initiative, and taking into account the nature of the infringements established, may:  - send a mission of inspection to the establishment concerned, or - instruct an official veterinarian, whose name shall be on a list to be prepared by the Commission at the suggestion of the Member States, and who is acceptable to the various parties concerned, to check the facts in the establishment concerned,  - request the competent authority to intensify its sampling of the products of the establishment concerned.  It shall inform the Member States of its findings.  Where these measures are taken to deal with repeated irregularities on the part of an establishment, the Commission shall charge any expenses occasioned by the application of the indents of the foregoing subparagraph to the establishment involved.  Pending the Commission's findings, the Member State of dispatch must, at the request of the Member State of destination, intensify checks on products coming from the establishment in question, and if there are serious animal health or public health  grounds, suspend approval.  The Member State of destination may, for its part, intensify checks on products coming from the same establishment.  At the request of one of the two Member States concerned - where the irregularities are confirmed by the expert's opinion - the Commission must, in accordance with the procedure laid down in Article 17, take the appropriate measures, which may go as far  as authorizing the Member States to prohibit provisionally the bringing into their territory of products coming from that establishment. These measures must be confirmed or reviewed as soon as possible in accordance with the procedure laid down in  Article 17.  The general rules for the application of this Article shall be adopted in accordance with the procedure set out in Article 18.  2.  Rights of appeal existing under the laws in force in the Member States against decisions by the competent authorities shall not be affected by this Directive.  Decisions taken by the competent authority of the State of destination and the reasons for such decisions shall be notified to the consignor or his representative and to the competent authority of the Member State of dispatch.  If the consignor or his representative so requests, the said decisions and reasons shall be forwarded to him in writing with details of the rights of appeal which are available to him under the law in force in the Member State of destination and of the  procedure and time limits applicable.  However, in the event of a dispute, and without prejudice to the aforementioned rights of appeal, the two parties concerned may, if they so agree, within a maximum period of one month, submit the dispute for the assessment of an expert whose name  appears on a list of Community experts to be drawn up by the Commission; the cost of consulting the expert shall be borne by the Community.  Such experts shall issue their opinions within not more than 72 hours. The parties shall abide by the expert's opinion, with due regard for Community veterinary legislation.  3.  The costs of returning the consignment, storing the goods, putting them to other uses or destroying them shall be borne by the consignee.   CHAPTER III Common provisions Article 9 1.  Each Member State shall immediately notify the other Member States and the Commission of any outbreak in its territory, other than an outbreak of diseases referred to in Directive 82/894/EEC, of any zoonoses, diseases or other cause likely to constitute a serious hazard to animals or to human health.  The Member State of origin shall immediately implement the control or precautionary measures provided for in Community rules, in particular the determination of the buffer zones provided for in those rules, or adopt any other measure which it deems  appropriate.  The Member State of destination or transit which, in the course of a check referred to in Article 5, has established the existence of one of the diseases or causes referred to in the first subparagraph may, if necessary, take the precautionary measures  provided for in Community rules.  Pending the measures to be taken in accordance with paragraph 4, the Member State of destination may, on serious public or animal-health grounds, take interim protective measures with regard to the establishments concerned or, in the case of an  epizootic disease, with regard to the area of protection provided for in Community rules.  The measures taken by Member States shall be notified to the Commission and to the other Member States without delay.  2.  At the request of the Member State referred to in the first subparagraph of paragraph 1 or on the initiative of the Commission, one or more Commission representatives may go at once to the place concerned to examine, in collaboration with the  competent authorities, what measures have been taken, and shall issue an opinion on those measures.  3.  If the Commission has not been informed of the measures taken, or if it considers the measures taken to be inadequate, it may, in collaboration with the Member State concerned and pending the meeting of the Standing Veterinary Committee, take  interim protective measures with regard to products from the region affected by the epizootic disease or from a given establishment. These measures shall be submitted to the Standing Veterinary Committee as soon as possible to be confirmed, amended or  cancelled in accordance with the procedure laid down in Article 17.  4.  The Commission shall in all cases review the situation in the Standing Veterinary Committee at the earliest opportunity. It shall adopt the necessary measures for the products referred to in Article 1 and, if the situation so requires, for the  originating products or products derived from those products in accordance with the procedure laid down in Article 17. The Commission shall monitor the situation and, by the same procedure, shall amend or repeal the decisions taken, depending on how the  situation develops.  5.  Detailed rules for the application of this Article, and in particular the list of zoonoses or causes likely to constitute a serious hazard to human health, shall be adopted in accordance with the procedure laid down in Article 18.  Article 10 Each Member State and the Commission shall appoint the veterinary department or departments responsible for carrying out the veterinary checks and collaborating with the other Member States' inspection departments.  Article 11 The Member States shall also ensure that the officials of their veterinary departments, if appropriate in collaboration with the officials of other departments empowered to that end, are able in particular to:  - carry out inspections of premises, offices, laboratories, installations, means of transport, plant and equipment, cleaning and maintenance products, procedures used for the production and processing of products and the marking and labelling and  presentation of those products,  - carry out checks on whether staff comply with the requirements laid down in the texts referred to in Annex A,  - take samples from products held with a view to being stored or sold, put on the market or transported;  - examine documentary or computer material relevant to the checks carried out further to the measures taken pursuant to Article 3 (1).  For this purpose, they must receive from the establishments being checked the cooperation necessary for the performance of their duties.  Article 12 1.  Article 8 (3) and Articles 10 and 11 of Directive 64/433/EEC (8), as last amended by Directive 88/657/EEC (9) are deleted.  2.  Article 5 (3) and (4), and Articles 9, 10 and 11 of Directive 71/118/EEC (10) as last amended by Directive 88/657/EEC are deleted.  3.  In Directive 74/461/EEC (11) as last amended by Directive 87/489/EEC (12):  i(i)  Articles 5 (2), (3), (4) and (5) and Articles 6 and 8 are deleted;  (ii)  in Article 8a, the references to Article 8 are replaced by a reference to Article 9 of Directive 89/662/EEC.   4.  Article 7 (3) and Articles 12 and 16 of Directive 77/99/EEC (13), as last amended by Directive 89/227/EEC (14), is deleted.  5.  In Directive 80/215/EEC:  i(i)  Article 5 (2), (3), (4) and (5) and Articles 6 and 7 are deleted;  (ii)  in Article 7a, the references to Article 7 is replaced by a reference to Article 9 of Directive 89/662/EEC.  6.  Article 5 (3) and (4), and Article 7, 8 and 12 of Directive 85/397/EEC (15), as amended by Regulation (EEC) No 3768/85 (16), are deleted.  7.  Article 10 (1) and (3) of Directive 88/657/EEC is deleted.  8.  Articles 8 and 9 of Directive 89/437/EEC (17) are deleted.  9.  In Annex B to Directive 72/462/EEC (18), the following shall be added to the certificate: 'Name and address of first consignee'.  Article 13 1.  The following Article is added to Directives 64/433/EEC and 71/118/EEC:  'Article 19 The Rules laid down in Directive 89/662/EEC (*) concerning veterinary checks applicable in intra-Community trade, with a view to the completion of the internal market, shall apply in particular to checks at origin, to the organization of and follow-up  to the checks to be carried out by the Member State of destination, and to the protective measures to be implemented.  (*) OJ No L 395, 30. 12. 1989, p. 13'.  2.  The following Article is added to Directives 72/461/EEC and 80/215/EEC:  'Article 15 The rules laid down in Directive 89/662/EEC (*) concerning veterinary checks applicable in intra-Community trade, with a view to the completion of the internal market, shall apply in particular to checks at  origin, to the origanization of and follow-up to the checks to be carried out by the Member State of destination, and to the protective measures to be implemented.  (*) OJ No L 395, 30. 12. 1989, p. 13.' 3.  The following Article is added to Directive 77/99/EEC:  'Article 24 The Rules laid down in Directive 89/662/EEC (*) concerning veterinary checks applicable in intra-Community trade, with a view to the completion of the internal market, shall apply in particular to checks at origin, to the organization of and follow-up  to the checks to be carried out by the Member State of destination, and to the protective measures to be implemented.  (*) OJ No L 395, 30. 12. 1989, p. 13.' 4.  The following Article shall be added to Directives 85/397/EEC and 88/657/EEC:  'Article 18 The Rules laid down in Directive 89/662/EEC (*) concerning veterinary checks applicable in intra-Community trade, with a view to the completion of the internal market, shall apply in particular to checks at origin, to the organization of and follow-up  to the checks to be carried out by the Member State of destination, and to the protective measures to be implemented.  (*) OJ No L 395, 30. 12. 1989, p. 13'.  5.  The following Article is added to Directive 88/437/EEC:  'Article 17 The Rules laid down in Directive 89/662/EEC (*) concerning veterinary checks applicable in intra-Community trade, with a view to the completion of the internal market, shall apply in particular to checks at origin, to the organization of and follow-up  to the checks to be carried out by the Member State of destination, and to the protective measures to be implemented.  (*) OJ No L 395, 30. 12. 1989, p. 13'.  Article 14 Until 31 December 1992, trade in the products listed in Annex B shall, pending the adoption of Community rules, be subject to the rules on control laid down by this Directive, in particular those laid down in Article 5 (2).  Member States shall communicate before the date laid down in Article 19 the conditions and procedures currently applicable to trade in the products referred to in the first subparagraph.  The Council, acting on a proposal from the Commission, shall determine the final arrangements applicable to trade in the products listed in Annex B before 31 December 1991.  Article 15 In Article 9 of Directive 64/432/EEC (19), the following point is inserted:  '2a.  One or more Commission representatives may, at the request of a Member State or at the initiative of the Commission itself, go at once to the place concerned to examine, in cooperation with the competent authorities, the measures taken and issue  an opinion on those measures.'.  Article 16 1.  Member States shall submit to the Commission no later than three months before the date laid down in Article 19 (1) a programme setting out the national measures to be taken to achieve the stated objective of this Directive, in particular  the frequency of checks.  2.  The Commission shall examine the programmes communicated by the Member States in accordance with paragraph 1.  3.  Each year and for the first time in 1991, the Commission shall address to the Member States a recommendation on a programme of checks for the following year; the Standing Veterinary Committee will have expressed its opinion on the recommendation in  advance. This recommendation may be subject to later adaptations.  Article 17 1.  Where the procedure laid down in this Article is to be used, matters shall without delay be referred by the Chairman, either on his own initiative or at the request of a Member State, to the Standing Veterinary Committee (hereinafter  called the 'Committee') set up by Decision 68/361/EEC (20).  2.  The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of  decisions which the Council is required to adopt on a  proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote.  3.  The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.  4.  If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken.  The Council shall act by a qualified majority.  If, on the expiry of a period of 15 days from the date of referral to the Council, the Council has not acted, the Commission shall adopt the proposed measures, save where the Council has decided against the said measures by a simple majority.  Article 18 1.  Where the procedure laid down in this Article is to be used, matters shall without delay be referred by the Chairman, either on his own initiative or at the request of a Member State, to the Standing Veterinary Committee (hereinafter  called 'the Committee') set up by Decision 68/361/EEC.  2.  The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter.  The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the  Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote.  3.  The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.  4.  If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken.  The Council shall act by a qualified majority.  If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the Commission shall adopt the proposed measures and implement them immediately, save where the Council has decided against the said  measures by a simple majority.  CHAPTER IV Transitional and Final Provisions Article 19 1.  Before 31 December 1990 the Council shall act by a qualified majority on the Commission proposal concerning veterinary checks in intra-Community trade in live animals.  Before the date referred to in the first subparagraph, the Council, acting by a qualified majority on a proposal from the Commission, shall decide on the rules and general principles applicable to checks on imports from third countries of products  covered by this Directive. In the same way, the check posts on the external frontiers, together with the requirements that these posts will have to satisfy, shall be fixed before that date.  2.  Before 31 December 1992 the Council shall review the provisions of this Directive on the basis of a report from the Commission on the experience gained, accompanied by any relevant proposals, on which it will decide by a qualified majority.  Article 20 Until 31 December 1992 and in order to permit the gradual implementation of the checking arrangements laid down by this Directive, Member States may, by way of derogation from Article 5 (1):  - maintain documentary checks during transport on meat and on products deriving therefrom, in order to ensure compliance with the specific requirements laid down by Community rules concerning foot and mouth disease and swine fever,  - operate documentary checks during transport on products imported from third countries intended for them.  Article 21 The Council, acting by a qualified majority on a proposal from the Commission, shall, before 1 October 1992, determine the arrangements applicable on the expiry of the transitional provisions laid down in Article 20.  Article 22 The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on a date to be fixed in the decision to be taken before 31 December 1990, in accordance with the second  subparagraph of Article 19 (1), but not later than 31 December 1991.  However, the Hellenic Republic shall have a further period of one year within which to comply therewith.  Article 23 This Directive is addressed to the Member States.   Done at Brussels, 11 December 1989.  For the Council The President H. NALLET  (1) OJ No C 225, 31. 8. 1988, p. 4. (2) OJ No C 326, 19. 12. 1988, p. 28. (3) OJ No L 56, 6. 3. 1989, p. 7.(4) OJ No L 378, 31. 12. 1987, p. 58. (5) OJ No L 61, 4. 3. 1989, p. 48. (6) OJ No L 47, 21. 2. 1980, p. 4. (7) OJ No L 382, 31. 12. 1988, p. 35.(8) OJ No 121, 29. 7. 1964, p. 2012/64. (9) OJ No L 382, 21. 12. 1988, p. 3. (10) OJ No L 55, 8. 3. 1971, p. 23. (11) OJ No L 302, 31. 12. 1972, p. 24. (12) OJ No L 280, 3. 10. 1987, p. 28.(13) OJ No L 26, 31. 1. 1977, p. 85. (14) OJ No L 93, 6. 4. 1989, p. 25. (15) OJ No L 226, 24. 8. 1985, p. 13. (16) OJ No L 362, 31. 12. 1985, p. 8. (17) OJ No L 212, 22. 7. 1989, p. 87. (18) OJ No L 302, 31. 12. 1972, p. 28.(19) OJ No 121, 29. 7. 1964, p. 1977/64. (20) OJ No L 255, 18. 10. 1968, p. 23.   ANNEX A   Veterinary legislation  - Council Directive 64/433/EEC of 26 June 1964 on health problems affecting intra-Community trade in fresh meat (OJ No 121, 29. 7. 1964, p. 2012/64), as last amended by Directive 88/657/EEC (OJ No L 382,  31. 12. 1988, p. 3),  - Council Directive 71/118/EEC of 15 February 1971 on health problems affecting trade in fresh poultrymeat (OJ No L 55, 8. 3. 1971, p. 23), as last amended by Directive 88/657/EEC (OJ No L 382, 31. 12. 1988, p. 3),  - Council Directive 72/461/EEC of 12 December 1972 on health problems affecting intra-Community trade in fresh meat (OJ No L 302, 31. 12. 1972, p. 24), as last amended by Directive 87/489/EEC (OJ No L 280,  3. 10. 1987, p. 28),  - Council Directive 77/99/EEC of 21 December 1976 on health problems affecting intra-Community trade in meat products (OJ No L 26, 31. 1. 1977, p. 85), as last amended by Directive 89/277/EEC (OJ No L 93,  6. 4. 1989, p. 25),  - Council Directive 80/215/EEC of 22 January 1980 on animal health problems affecting intra-Community trade in meat products (OJ No L 47, 21. 2. 1980, p 4), as last amended by Directive 88/660/EEC (OJ No L 382, 31. 12. 1988, p. 35),  - Council Directive 85/397/EEC of 5 August 1985 on health and animal health problems affecting intra-Community trade in heat-treated milk (OJ No L 226, 24. 8. 1985, p. 13), as last amended by Regulation (EEC) No 3768/85 of 20. 12. 1985 (OJ No L 362, 31.  12. 1985, p. 8),  - Council Directive 88/657/EEC of 14 December 1988 laying down the requirements for the production of,  and trade in, minced meat, meat in pieces of less than 100 grams and meat preparations (OJ No L 382,  31. 12. 1988, p. 3) (;),  - Council Directive 89/437/89 of 20 June 1989 on hygiene and health problems affecting the production and the placing on the market of egg products (OJ No L 212, 22. 7. 1989, p. 87) (;).    ANNEX B   Products not subject to Community harmonization, but trade in which would be subject to the checks provided for by this Directive  Products of animal origin covered by Annex II to the Treaty:  - rabbit and game meat,  - raw milk and milk products,  - aquaculture products intended for human consumption,  - fishery products intended for human consumption,  - live bivalve molluscs intended for human consumption,  - game and rabbit meat products,  - blood,  - offal of animal fats, greaves and by-products of rendering,  - honey,  - snails intended for human consumption,  - frogs' legs intended for human consumption.  (;) As from 1 January 1992.