Avis juridique important

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31984L0537

Council Directive 84/537/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to the permissible sound power level of powered hand- held concrete-breakers and picks

Official Journal L 300 , 19/11/1984 P. 0156 - 0170 Spanish special edition: Chapter 15 Volume 5 P. 0099  Portuguese special edition Chapter 15 Volume 5 P. 0099  Finnish special edition: Chapter 13 Volume 14 P. 0116  Swedish special edition: Chapter 13 Volume 14 P. 0116

+++++( 1 ) OJ NO C 82 , 14 . 4 . 1976 , P . 91 .  ( 2 ) OJ NO C 76 , 7 . 4 . 1975 , P . 37 .  ( 3 ) OJ NO C 263 , 17 . 11 . 1975 , P . 42 .  ( 4 ) OJ NO C 112 , 20 . 12 . 1973 , P . 1 AND OJ NO C 139 , 13 . 6 . 1977 , P . 1 .  ( 5 ) SEE PAGE 111 OF THIS OFFICIAL JOURNAL .  ( 6 ) OJ NO L 33 , 8 . 2 . 1979 , P . 15 .  ( 7 ) OJ NO L 376 , 30 . 12 . 1981 , P . 49 .  ( 8 ) THIS DIRECTIVE WAS NOTIFIED TO THE MEMBER STATES ON 26 SEPTEMBER 1984 .  COUNCIL DIRECTIVE OF 17 SEPTEMBER 1984 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO THE PERMISSIBLE SOUND POWER LEVEL OF POWERED HAND-HELD CONCRETE-BREAKERS AND PICKS ( 84/537/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 THE 1973 AND 1977 ACTION PROGRAMME OF THE EUROPEAN COMMUNITIES ON THE ENVIRONMENT ( 4 ) REFLECT THE IMPORTANCE OF THE PROBLEM OF NOISE NUISANCE AND IN PARTICULAR THE NEED FOR ACTION TO REGULATE THE WORST NOISE SOURCES ;  WHEREAS DISPARITY BETWEEN THE MEASURES ALREADY APPLICABLE OR IN PREPARATION IN THE VARIOUS MEMBER STATES CONCERNING THE LIMITATION OF THE SOUND EMISSION LEVEL OF POWERED HAND-HELD CONCRETE-BREAKERS AND PICKS CREATES UNEQUAL CONDITIONS OF COMPETITION AND THEREBY DIRECTLY AFFECTS THE FUNCTIONING OF THE COMMON MARKET ; WHEREAS IT IS THEREFORE APPROPRIATE TO PROCEED IN THAT FIELD WITH THE APPROXIMATION OF LAWS FOR WHICH ARTICLE 100 OF THE TREATY PROVIDES ;  WHEREAS COUNCIL DIRECTIVE 84/532/EEC OF 17 SEPTEMBER 1984 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO COMMON PROVISIONS FOR CONSTRUCTION PLANT AND EQUIPMENT ( 5 ) HAS LAID DOWN , IN PARTICULAR , THE PROCEDURE FOR EEC TYPE-EXAMINATION ; WHEREAS IT IS NECESSARY , PURSUANT TO THAT DIRECTIVE , TO PRESCRIBE THE HARMONIZED REQUIREMENTS WHICH EACH CATEGORY OF EQUIPMENT MUST SATISFY ;  WHEREAS COUNCIL DIRECTIVE 79/113/EEC OF 19 DECEMBER 1978 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO THE MEASUREMENT OF THE SOUND LEVEL OF CONSTRUCTION PLANT AND EQUIPMENT ( 6 ) , AS AMENDED BY COUNCIL DIRECTIVE 81/1051/EEC ( 7 ) LAID DOWN THE METHOD WHICH SHOULD BE USED FOR ESTABLISHING THE ACOUSTIC CRITERIA FOR POWERED HAND-HELD CONCRETE-BREAKERS AND PICKS ;  WHEREAS OWING TO THE EFFECT OF THE NOISE EMITTED BY POWERED HAND-HELD CONCRETE-BREAKERS AND PICKS ON THE ENVIRONMENT AND , MORE PARTICULARLY , ON HUMAN WELL-BEING AND HEALTH , IT IS NECESSARY TO BRING ABOUT A PROGRESSIVE AND APPRECIABLE REDUCTION IN THE PERMISSIBLE SOUND POWER LEVEL OF POWERED HAND-HELD CONCRETE-BREAKERS AND PICKS ;  WHEREAS IT IS IMPORTANT TO BE ABLE TO REGULATE THE USE OF POWERED HAND-HELD CONCRETE-BREAKERS AND PICKS IN CERTAIN AREAS CONSIDERED TO BE PARTICULARLY SENSITIVE , SO AS TO LIMIT THE NUISANCE CAUSED BY THE AIRBORNE NOISE EMITTED BY SUCH POWERED HAND-HELD CONCRETE-BREAKERS AND PICKS ;  WHEREAS TECHNICAL PROVISIONS MUST BE ADAPTED RAPIDLY TO TECHNICAL ADVANCES ; WHEREAS IT IS NECESSARY TO THIS END TO PROVIDE FOR THE APPLICATION OF THE PROCEDURE SET OUT IN ARTICLE 5 OF DIRECTIVE 79/113/EEC ,  HAS ADOPTED THIS DIRECTIVE :  ARTICLE 1  1 . THIS DIRECTIVE APPLIES TO THE PERMISSIBLE SOUND POWER LEVEL FOR POWERED HAND-HELD CONCRETE-BREAKERS AND PICKS USED TO PERFORM WORK ON CIVIL ENGINEERING AND BUILDING SITES , ( HEREINAFTER REFERRED TO AS " APPLIANCES " ) .  2 . IT IS A SEPARATE DIRECTIVE WITHIN THE MEANING OF ARTICLE 3 ( 2 ) OF DIRECTIVE 84/532/EEC , HEREINAFTER REFERRED TO AS THE " FRAMEWORK DIRECTIVE " .  ARTICLE 2  1 . THE APPROVED BODIES SHALL ISSUE AN EEC TYPE-EXAMINATION CERTIFICATE FOR EACH TYPE OF APPLIANCE THE SOUND POWER LEVEL OF WHICH , MEASURED IN THE MANNER LAID DOWN IN ANNEX I TO DIRECTIVE 79/113/EEC , AS AMENDED BY ANNEX I TO THIS DIRECTIVE , DOES NOT EXCEED THE PERMISSIBLE SOUND POWER LEVEL GIVEN IN THE FOLLOWING TABLE :  * PERMISSIBLE SOUND POWER LEVEL IN DB ( A ) /1 PW AS FROM  * MASS OF APPLIANCE ( M ) * 18 MONTHS AFTER NOTIFICATION OF THE DIRECTIVE * 5 YEARS AFTER NOTIFICATION OF THE DIRECTIVE  M < 20 KG * 110 * 108  20 KG + M + 35 KG * 113 * 111  M > 35 KG * 116 * 114  AND APPLIANCES WITH AN INTERNAL-COMBUSTION ENGINE INCORPORATED  2 . ALL APPLICATIONS FOR AN EEC TYPE-EXAMINATION CERTIFICATE IN RESPECT OF THE PERMISSIBLE SOUND POWER LEVEL OF AN APPLIANCE SHALL BE ACCOMPANIED BY AN INFORMATION DOCUMENT CONFORMING TO THE MODEL SHOWN IN ANNEX II .  3 . FOR EACH TYPE OF APPLIANCE WHICH IT CERTIFIES , THE APPROVED BODY SHALL COMPLETE ALL THE SECTIONS OF THE EEC TYPE-EXAMINATION CERTIFICATE CONFORMING TO THE MODEL GIVEN IN ANNEX III TO THE FRAMEWORK DIRECTIVE .  4 . THE PERIOD OF VALIDITY OF TYPE-EXAMINATION CERTIFICATES SHALL BE LIMITED TO FIVE YEARS . THIS MAY BE EXTENDED BY FIVE YEARS PROVIDED THAT APPLICATION IS MADE NO MORE THAN 12 MONTHS BEFORE THE EXPIRY OF THE FIRST FIVE-YEAR PERIOD .  AT THE END OF A PERIOD OF FIVE YEARS FROM NOTIFICATION OF THE DIRECTIVE , HOWEVER , EEC TYPE-EXAMINATION CERTIFICATES SHALL CEASE TO BE VALID UNLESS THEY WERE ISSUED FOR APPLIANCES WHICH MEET THE STANDARDS ENTERING INTO FORCE ON THAT DATE .  5 . BY WAY OF DEROGATION FROM ARTICLE 19 ( 1 ) OF THE FRAMEWORK DIRECTIVE , THE ADVANTAGES PROVIDED FOR IN THIS ARTICLE SHALL , AFTER A PERIOD OF 5 1/2 YEARS FROM NOTIFICATION OF THE DIRECTIVE , NO LONGER BE AVAILABLE FOR APPLIANCES SUPPLIED WITH CERTIFICATES OF CONFORMITY DRAWN UP ON THE BASIS OF AN EEC TYPE-EXAMINATION CERTIFICATE FOR THE FIGURES IN THE FIRST PERIOD ; THE PERIOD OF VALIDITY SHALL ACCORDINGLY BE SHOWN ON THE CERTIFICATES OF CONFORMITY CONCERNED .  6 . FOR EVERY APPLIANCE BUILT IN CONFORMITY WITH THE TYPE CERTIFIED BY EEC TYPE-EXAMINATION , THE MANUFACTURER SHALL COMPLETE A CERTIFICATE OF CONFORMITY CONFORMING TO THE MODEL GIVEN IN ANNEX IV TO THE FRAMEWORK DIRECTIVE IN THE COLUMNS RELATING TO THE EEC TYPE-EXAMINATION CERTIFICATE .  7 . EACH APPLIANCE BUILT IN ACCORDANCE WITH THE TYPE CERTIFIED BY EEC TYPE-EXAMINATION SHALL BEAR A CLEAR AND PERMANENT MARK INDICATING THE SOUND POWER LEVEL IN DB ( A ) TO 1 PW GUARANTEED BY THE MANUFACTURER AND DETERMINED AS LAID DOWN IN ANNEX I TO DIRECTIVE 79/113/EEC , AS AMENDED BY ANNEX I TO THIS DIRECTIVE , AND THE SYMBOL * ( EPSILON ) . THE MODEL OF SUCH MARK IS SHOWN IN ANNEX III TO THIS DIRECTIVE .  ARTICLE 3  MEMBER STATES MAY TAKE MEASURES TO REGULATE THE USE OF APPLIANCES IN AREAS WHICH THEY CONSIDER SENSITIVE .  ARTICLE 4  VERIFICATION OF THE CONFORMITY OF PRODUCTION MODELS WITH THE TYPE EXAMINED , AS PROVIDED FOR IN ARTICLE 12 OF THE FRAMEWORK DIRECTIVE , SHALL BE CARRIED OUT USING THE TECHNICAL PROCEDURE STIPULATED IN ANNEX IV .  ARTICLE 5  THE COUNCIL SHALL ACT UNANIMOUSLY , WITHIN 18 MONTHS , ON THE PROPOSAL FOR A REDUCTION IN THE NOISE LEVELS WHICH THE COMMISSION WILL PRESENT AS SOON AS POSSIBLE AND NO LATER THAN FIVE YEARS AFTER THE ADOPTION OF THIS DIRECTIVE .  ARTICLE 6  THE FOLLOWING SHALL BE ADOPTED IN ACCORDANCE WITH THE PROCEDURE LAID DOWN IN ARTICLE 5 OF DIRECTIVE 79/113/EEC ,  - THE TECHNICAL PROCEDURE IN ANNEX IV FOR THE CHECKING OF THE CONFORMITY OF PRODUCTION MODELS WITH THE TYPE EXAMINED ,  - THE AMENDMENTS NECESSARY TO ADAPT THE REQUIREMENTS OF THE ANNEXES TO TECHNICAL PROGRESS .  ARTICLE 7  MEMBER STATES SHALL TAKE ALL THE NECESSARY MEASURES TO ENSURE THAT APPLIANCES CANNOT BE PLACED ON THE MARKET UNLESS THEY SATISFY THE PROVISIONS OF THIS DIRECTIVE AND OF THE FRAMEWORK DIRECTIVE .  ARTICLE 8  1 . MEMBER STATES SHALL BRING INTO FORCE THE LAWS , REGULATIONS AND ADMINISTRATIVE PROVISIONS NECESSARY IN ORDER TO COMPLY WITH THIS DIRECTIVE ON THE EXPIRY OF A PERIOD OF 18 MONTHS AS OF ITS NOTIFICATION ( 8 ) AND SHALL FORTHWITH INFORM THE COMMISSION THEREOF .  2 . MEMBER STATES SHALL ENSURE THAT THE TEXTS OF THE PROVISIONS OF NATIONAL LAW WHICH THEY ADOPT IN THE FIELD COVERED BY THIS DIRECTIVE ARE COMMUNICATED TO THE COMMISSION .  ARTICLE 9  THIS DIRECTIVE IS ADDRESSED TO THE MEMBER STATES .  DONE AT BRUSSELS , 17 SEPTEMBER 1984 .  FOR THE COUNCIL  THE PRESIDENT  P . BARRY  ANNEX I  METHOD OF MEASURING AIRBORNE NOISE EMITTED BY POWERED HAND-HELD CONCRETE-BREAKERS AND PICKS  SCOPE  THIS MEASUREMENT METHOD IS APPLICABLE TO POWERED HAND-HELD CONCRETE-BREAKERS AND PICKS , HEREINAFTER REFERRED TO AS " APPLIANCES " . IT SPECIFIES THE TEST PROCEDURES FOR USE IN DETERMINING THE SOUND POWER LEVEL OF SUCH EQUIPMENT FOR THE PURPOSE OF EEC TYPE-EXAMINATION AND TESTING AS TO CONFORMITY .  THESE TECHNICAL PROCEDURES SHALL COMPLY WITH THE REQUIREMENTS OF ANNEX I TO DIRECTIVE 79/113/EEC .  ALL THE SECTIONS IN ANNEX I TO DIRECTIVE 79/113/EEC SHALL APPLY TO APPLIANCES , SUBJECT TO THE FOLLOWING AMENDMENTS :  4 . CRITERIA TO BE USED FOR EXPRESSING RESULTS  4.1 . THE ACOUSTIC CRITERION FOR THE ENVIRONMENT OF AN APPLIANCE SHALL BE EXPRESSED BY ITS SOUND POWER LEVEL .  6 . MEASURING CONDITIONS  6.1.1 . DETERMINING THE MASS OF AN APPLIANCE .  WHEN THE MASS IS BEING DETERMINED , THE APPLIANCE SHALL BE FITTED OUT AS FOR NORMAL USE , EXCEPT FOR THE TOOL , THE SUPPLY TUBE AND , WHERE APPROPRIATE , THE COUPLING .  6.1.2 . SUPPORTS OF THE APPLIANCE .  ( A ) TO ENSURE THAT THE TESTS ARE COMPLETELY REPRODUCIBLE , THE APPLIANCE SHALL BE COUPLED DURING THE TEST RUN TO A TOOL EMBEDDED IN A CUBE-SHAPED CONCRETE BLOCK PLACED IN A CONCRETED PIT SUNK INTO THE GROUND .  ( B ) AN INTERMEDIATE STEEL PIECE MAY BE INSERTED DURING TESTS BETWEEN THE APPLIANCE AND THE SUPPORT TOOL . THIS INTERMEDIATE PIECE SHALL FORM A STABLE STRUCTURE BETWEEN THE APPLIANCE AND THE SUPPORT TOOL . THE DIAGRAM IN FIGURE 2 INCORPORATES THESE REQUIREMENTS .  6.1.3 . BLOCK CHARACTERISTICS .  THE BLOCK SHALL BE IN THE SHAPE OF A CUBE , 0,60 M MORE OR LESS 2 MM LONG AT THE EDGE AND AS REGULAR AS POSSIBLE ; IT SHALL BE MADE OF REINFORCED CONCRETE AND THOROUGHLY VIBRATED IN LAYERS OF UP TO 0,20 M TO AVOID EXCESSIVE SEDIMENTATION .  THE DISTANCE BETWEEN THE EXTREMITY OF THE APPLIANCE ( WITHOUT THE TOOL ) AND THE SCREENING SLAB SHALL BE BETWEEN 0,10 AND 0,20 M .  6.1.4 . COMPOSITION OF THE CONCRETE .  FOR ONE 50-KILOGRAM SACK OF PURE PORTLAND CEMENT , CATEGORY 400 OR EQUIVALENT :  - 65 LITRES OF UNGRADED , NON-CALCAREOUS SAND WITH A GRAIN SIZE OF 0,1 MM TO 5 MM ,  - 115 LITRES OF NON-CALCAREOUS ALLUVIAL GRAVEL WITH A GRAIN SIZE OF 5 TO 25 MM ,  THE CUBE SHALL BE REINFORCED BY 8-MM-DIAMETER STEEL RODS WITHOUT TIES , EACH ROD BEING INDEPENDENT OF THE OTHERS ; THE DESIGN CONCEPT IS ILLUSTRATED IN FIGURE 1 .  6.1.5 . SUPPORTING TOOL .  THE TOOL SHALL BE SEALED INTO THE BLOCK AND SHALL CONSIST OF A RAMMER OF NO LESS THAN 178 MM OR NO MORE THAN 220 MM DIAMETER AND A TOOL CHUCK COMPONENT IDENTICAL TO THAT NORMALLY USED WITH THE APPLIANCES BEING TESTED AND COMPLYING WITH ISO RECOMMENDATIONS R 1180 AND R 1571 BUT SUFFICIENTLY LONG TO ENABLE THE PRACTICAL TEST TO BE CARRIED OUT .  SUITABLE TREATMENT SHALL BE CARRIED OUT TO INTEGRATE THE TWO COMPONENTS . THE TOOL SHALL BE FIXED IN THE BLOCK SO THAT THE BOTTOM OF THE RAMMER IS 0,30 M FROM THE UPPER FACE OF THE BLOCK ( SEE FIGURE 1 ) .  THE BLOCK SHALL REMAIN MECHANICALLY SOUND , PARTICULARLY AT THE POINT WHERE THE SUPPORTING TOOL AND THE CONCRETE MEET . BEFORE AND AFTER EACH TEST , IT SHALL BE ESTABLISHED THAT THE TOOL SEALED IN THE CONCRETE BLOCK IS INTEGRATED WITH IT .  6.1.6 . POSITIONING OF THE CUBE .  THE CUBE SHALL BE SET IN A PIT CEMENTED THROUGHOUT , COVERED BY A SCREENING SLAB OF AT LEAST 100 KG/M2 , AS INDICATED IN THE ATTACHED FIGURE 4 , SO THAT THE UPPER SURFACE OF THE SCREENING SLAB IS FLUSH WITH THE GROUND . TO AVOID ANY PARASITIC NOISE , THE BLOCK SHALL BE INSULATED AGAINST THE BOTTOM AND SIDES OF THE PIT BY ELASTIC BLOCKS , THE CUT-OFF FREQUENCY OF WHICH SHALL NOT BE MORE THAN HALF THE STRIKING RATE OF THE APPLIANCE TESTED , EXPRESSED AS STROKES PER SECOND .  THE OPENING IN THE SCREENING SLAB THROUGH WHICH THE TOOL CHUCK COMPONENT PASSES SHALL BE AS SMALL AS POSSIBLE AND SEALED BY A FLEXIBLE SOUND-PROOF JOINT .  6.2 . OPERATION OF THE SOUND SOURCE DURING MEASUREMENTS .  TO ENSURE THAT THE MEASUREMENTS MAY BE REPRODUCED , ALL APPLIANCES SHALL BE TESTED IN THE VERTICAL POSITION .  IN THE CASE OF PNEUMATIC APPLIANCES , THE AIR EXHAUST AXIS OF THE TEST APPLIANCE SHALL BE EQUIDISTANT FROM TWO MEASURING POINTS ( AIR EXHAUSTED DIRECTLY ON TO A MICROPHONE DISTORTS THE MEASUREMENT , WHICH CONSEQUENTLY HAS TO BE ABANDONED ) . THE MICROPHONE SHALL NOT BE PLACED BETWEEN THE APPLIANCE AND THE AIR RECEIVER ( SEE FIGURE 3 ) .  6.2.1 . NOT APPLICABLE .  6.2.2 . IN THE CASE OF PNEUMATIC APPLIANCES , THE OPERATION OF THE MACHINE SHALL HAVE THE SAME ACOUSTIC STABILITY AS IN NORMAL SERVICE AND SHALL SATISFY THE FOLLOWING REQUIREMENTS .  THE APPLIANCE SHALL OPERATE AT A WORKING PRESSURE OF 600 KPA .  IF THIS IS IMPOSSIBLE , THE PRESSURE USED AND THE REASONS WHY IT WAS IMPOSSIBLE TO USE THE STIPULATED PRESSURE SHALL BE INDICATED IN THE TEST REPORT .  DURING THE MEASUREMENTS , THE AIR PRESSURE SHALL BE MEASURED WHILE THE APPLIANCE IS IN OPERATION . THE APPLIANCE SHALL OPERATE NORMALLY ; ANY HINDRANCES TO THE AIR EXHAUST , SUCH AS ICING UP , SHALL BE AVOIDED . THE TYPE , QUALITY AND QUANTITY OF THE LUBRICATING OIL USED SHALL COMPLY WITH THE MANUFACTURER'S RECOMMENDATIONS .  IN THE CASE OF APPLIANCES POWERED OTHER THAN BY COMPRESSED AIR , THE OPERATING CONDITIONS SHALL BE THOSE CORRESPONDING TO THE MAXIMUM SPEED AT WHICH THE APPLIANCE CAN OPERATE CONTINUOUSLY , ACCORDING TO THE MANUFACTURER'S STATEMENT .  TEST SET-UP .  THE APPLIANCES SHALL RUN UNATTENDED BY AN OPERATOR IN THE MANNER DESCRIBED BELOW :  ( A ) THE APPLIANCE SHALL OPERATE IN AN UPRIGHT POSITION ON THE DEVICE DESCRIBED IN 6.1.5 , WHICH SHALL BE PROVIDED WITH A TOOL SHANK OF THE CORRECT SIZE FOR ATTACHMENT TO THE APPLIANCE ;  ( B ) THE APPLIANCE SHALL BE FIRMLY HELD DOWN BY A FLEXIBLE DEVICE IN ORDER TO GIVE THE SAME STABILITY AS THAT EXISTING UNDER NORMAL OPERATING CONDITIONS , WHEN THE TOOL IS EMBEDDED IN THE MATERIAL TO BE BROKEN UP BEFORE THE LATTER FRACTURES ; THE FLEXIBLE DEVICE MAY TAKE THE FORM OF CALIBRATED SPRINGS OR PNEUMATIC JACKS , FOR EXAMPLE .  PRESSURE CONTROL IN THE CASE OF APPLIANCES .  SINCE THE APPLIANCE HAS TO OPERATE AT 600 KPA OR AT ITS NOMINAL PRESSURE IF THIS IS DIFFERENT , THE PRESSURE SHALL BE CHECKED AT THE AIR INLET COUPLING TO THE APPLIANCE ( SEE FIGURE 3 ) .  THE PRESSURE MAY BE CHECKED BY MEANS OF A DIAL PRESSURE GAUGE BUT , IN VIEW OF THE PULSATION OF THE APPLIANCE , IT IS PREFERABLE TO USE AN ARRANGEMENT CONSISTING OF AN AIR RECEIVER OF 50 TO 100 LITRES CAPACITY SUPPLIED BY A 20-M-LONG 19-MM-DIAMETER TUBE . THE APPLIANCE SHALL BE SUPPLIED FROM THIS RECEIVER THROUGH A 25 - TO 30-MM-DIAMETER 4,5-M-LONG TUBE , CONNECTED TO THE COUPLING . THE AIR RECEIVER SHALL BE PLACED AS FAR AWAY AS POSSIBLE FROM THE APPLIANCE . THE PRESSURE INSIDE THE AIR RECEIVER SHALL BE MEASURED THROUGH A CONNECTION ON THE LATTER .  THE PRESSURE MAY BE ADJUSTED EITHER THROUGH THE OUTLET VALVE ON THE COMPRESSOR OR BY LEAKING PRESSURE FROM THE AIR RECEIVER THROUGH AN ADJUSTABLE SILENCER .  THIS DEVICE IS ILLUSTRATED SCHEMATICALLY IN FIGURE 3 .  6.3 . THE TEST AREA SHALL BE A MINIMUM OF 4 M IN RADIUS .  6.4.1 . MEASURING SURFACE .  THE MEASURING SURFACE TO BE USED FOR TESTING SHALL BE A HEMISPHERE . THE CENTRE OF THE HEMISPHERE SHALL BE THE VERTICAL PROJECTION ON TO THE REFLECTING PLANE OF THE GEOMETRIC CENTRE OF THE APPLIANCE . THE RADIUS IS GIVEN IN THE FOLLOWING TABLE :  MASS OF THE APPLIANCE AS NORMALLY USED * RADIUS OF THE HEMISPHERE * VALUE OF Z FOR POINTS 1 TO 8  LESS THAN 10 KG * 2 M * 0,75 M  10 KG OR MORE * 4 M * 1,50 M  6.4.2.2 . MEASURING POINTS .  FOR EACH APPLIANCE , THERE SHALL BE 12 MEASURING POINTS WITH THE VARIATIONS IN THE VALUE OF Z OF POINTS 1 TO 8 AS SHOWN IN THE PREVIOUS TABLE .  7 . MEASUREMENTS  7.1.1 . ONLY THE BACKGROUND NOISE SHALL BE TAKEN INTO ACCOUNT FOR THE PURPOSE OF CORRECTIONS .  8 . USE OF RESULTS  8.2 . NOT APPLICABLE .  8.6.2 . SINCE THE GROUND SURFACE OF THE TEST AREA IS MADE OF CONCRETE OR NON-POROUS ASPHALT , 8.6.2 IS NOT APPLICABLE AND C = 0 .  8.6.3 . THE ICING-UP WHICH IS CHARACTERISTIC OF THE OPERATION OF PNEUMATIC APPLIANCES SHALL BE AVOIDED DURING THE MEASUREMENTS .  9 . DATA TO BE RECORDED  A MODEL REPORT IS GIVEN IN THE APPENDIX .  TEST BLOCK  CUBE 0,60 M ALONG THE EDGE , FULLY VIBRATED  COMPOSITION : 1 SACK PURE PORTLAND CEMENT , CATEGORY 400 OR EQUIVALENT  65 LITRES NON-CALCAREOUS SAND , UNGRADED , GRAIN SIZE 0,1 TO 5 MM  115 LITRES NON-CALCAREOUS GRAVEL , GRAIN SIZE 5 TO 25 MM  SCHEMATIC DIAGRAM  INTERMEDIATE PIECE REFERRED TO IN 6.1.2  DIAGRAM OF DEVICE FOR SUPPLYING COMPRESSED AIR  APPENDIX  MODEL REPORT  TEST REPORT FOR POWERED PICKS AND CONCRETE-BREAKERS  1 . TEST ARTICLE  MANUFACTURER  MODEL SERIAL NO  PRINCIPAL DIMENSIONS  DESCRIPTION MASS  TYPE : COMPRESSED AIR , HYDRAULIC , ELECTRIC , PETROL ( 1 )  2 . OPERATING CONDITIONS  2.1 . PNEUMATIC  OPERATING PRESSURE PASCALS  AIR INTAKE M3/SEC  STRIKING RATE STROKES/SEC  SOUNDPROOFING DEVICE  2.2 . HYDRAULIC  HYDRAULIC FLUID PRESSURE PASCALS  STRIKING RATE STROKES/SEC  2.3 . ELECTRIC  OPERATING VOLTAGE VOLTS  STRIKING RATE STROKES/SEC  2.4 . PETROL  ENGINE SPEED RPM  MAKE AND TYPE OF SILENCER USED ( OR FITTED )  STRIKING RATE STROKES/SEC  SOUNDPROOFING DEVICE  3 . TEST CONDITIONS  BAROMETRIC PRESSURE AMBIENT TEMPERATURE  COMPOSITION AND DIMENSIONS OF REFLECTING SURFACE  REMARKS  4 . EQUIPMENT  MICROPHONE SERIAL NO  SOUND-LEVEL METER SERIAL NO  OCTAVE-BAND ANALYZER SERIAL NO  CALIBRATING EQUIPMENT SERIAL NO  MISCELLANEOUS ( E . G . WIND SHIELD OR RECORDER )  SERIAL NO  5 . DIAGRAM SHOWING MICROPHONE LOCATIONS AND , IF APPLICABLE , THE DIRECTION OF THE EXHAUST AND THE POSITION OF ANY LARGE OBJECTS SITUATED LESS THAN 25 M FROM THE APPLIANCE UNDER TEST  6 . ACOUSTIC DATA :  - AREA S IN M2 OF MEASURING SURFACE AND VALUE OF 10 LOG10 * ;  - SOUND-PRESSURE LEVELS MEASURED AT MEASURING POINTS ;  - AVERAGE SOUND-PRESSURE LEVEL OVER MEASURING SURFACE ;  - ANY CORRECTIONS IN DECIBELS ;  - SURFACE SOUND-PRESSURE LEVEL LPAM ;  - SOUND-POWER LEVEL ;  - DIRECTIVITY INDEX AND NUMBER OF THE MEASURING POINT AT WHICH LPAMAX WAS RECORDED ;  - NATURE OF NOISE :  ( AUDIBLE DISCRETE TONES , IMPULSE , TIME-RELATED CHARACTERISTICS , ETC . ) ;  - DATE AND TIME OF MEASUREMENTS .  ( 1 ) DELETE AS APPROPRIATE .  ANNEX II  MODEL INFORMATION DOCUMENT FOR A TYPE OF POWERED HAND-HELD CONCRETE-BREAKER OR PICK TO BE SUBMITTED FOR ITS EEC TYPE-EXAMINATION  1 . GENERAL  1.1 . NAME AND ADDRESS OF MANUFACTURER  1.2 . NAME AND ADDRESS OF MANUFACTURER'S AUTHORIZED REPRESENTATIVE ( IF ANY )  1.3 . MAKE ( NAME OF UNDERTAKING )  1.4 . TRADE NAME ( MENTION ANY VARIATIONS )  1.5 . TYPE  1.6 . LOCATION OF STATUTORY PLATES AND INSCRIPTIONS AND METHOD OF FIXING  2 . MASS  2.1 . MASS KG  3 . OPERATION  3.1 . PNEUMATIC  3.1.1 . OPERATING PRESSURE PASCALS  3.1.2 . AIR INTAKE M3/SEC  3.1.3 . STRIKING RATE STROKES/SEC  3.1.4 . SOUNDPROOFING DEVICE : FITTED , REMOVABLE ( 1 ) ( MAKE AND TYPE )  3.2 . HYDRAULIC  3.2.1 . HYDRAULIC FLUID PRESSURE  3.2.2 . STRIKING RATE STROKES/SEC  3.2.3 . SOUNDPROOFING DEVICE : FITTED , REMOVABLE ( 1 ) ( MAKE AND TYPE )  3.2.4 . INERTIAL MASS  3.2.5 . MASS UNDER MOVEMENT  3.2.6 . ENERGY CONSUMPTION PER MINUTE  3.3 . ELECTRIC  3.3.1 . OPERATING VOLTAGE V  3.3.2 . STRIKING RATE STROKES/SEC  3.3.3 . SOUNDPROOFING DEVICE : FITTED , REMOVABLE ( 1 ) ( MAKE AND TYPE )  3.3.4 . INERTIAL MASS  3.3.5 . MASS UNDER MOVEMENT  3.3.6 . ENERGY CONSUMPTION  3.4 . PETROL  3.4.1 . ENGINE SPEED RPM  3.4.2 . STRIKING RATE STROKES/SEC  3.4.3 . MAKE AND TYPE OF SILENCER USED  3.4.4 . SOUNDPROOFING DEVICE : FITTED , REMOVABLE ( 1 ) ( MAKE AND TYPE )  4 . ADDITIONAL DATA  4.1 . OUTLINE ( SHOWING SCALE ) OR PHOTOGRAPH OF THE APPLIANCE  4.2 . ADDRESS FROM WHICH FURTHER NECESSARY DATA MAY BE OBTAINED  5 . ATTACH DESCRIPTIVE TRADE LEAFLET , IF ANY .  ( 1 ) DELETE AS APPROPRIATE .  ANNEX III  MODEL FOR MARK FOR SOUND POWER LEVEL  ANNEX IV  TECHNICAL PROCEDURE FOR CHECKING THE CONFORMITY OF PRODUCTION MODELS WITH THE APPROVED TYPE  THE CONFORMITY OF PRODUCTION MODELS WITH THE APPROVED TYPE SHALL , IF POSSIBLE , BE VERIFIED BY SPOT CHECKS .


Avis juridique important

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31979L1073

Commission Directive 79/1073/EEC of 22 November 1979 adapting to technical progress Council Directive 74/347/EEC on the approximation of the laws of the Member States relating to the field of vision and windscreen wipers of wheeled agricultural of forestry tractors

Official Journal L 331 , 27/12/1979 P. 0020 - 0023 Finnish special edition: Chapter 13 Volume 10 P. 0174  Greek special edition: Chapter 13 Volume 9 P. 0083  Swedish special edition: Chapter 13 Volume 10 P. 0174  Spanish special edition: Chapter 13 Volume 10 P. 0288  Portuguese special edition Chapter 13 Volume 10 P. 0288

COMMISSION DIRECTIVE  of 22 November 1979  adapting to technical progress Council Directive 74/347/EEC on the approximation of the laws of the Member States relating to the field of vision and windscreen wipers of wheeled agricultural or forestry tractors  (79/1073/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors (1), as last amended by Directive 79/694/EEC (2), and in particular Articles 11, 12 and 13 thereof,  Having regard to Council Directive 74/347/EEC of 25 June 1974 on the approximation of the laws of the Member States relating to the field of vision and windscreen wipers of wheeled agricultural or forestry tractors (3),  Having regard to Council Directive 77/536/EEC of 28 June 1977 on the approximation of the laws of the Member States relating to the roll-over protection structures of wheeled agricultural or forestry tractors (4),  Whereas, in view of experience gained and the provisions adopted concerning roll-over protection structures which affect the configuration of those parts of the tractor superstructure which are of great importance for the field of vision, it is now possible to adapt to technical progress the provisions relating to the field of vision;  Whereas traffic safety requirements in respect of wheeled agricultural or forestry tractors have become more stringent;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of Directives for the Removal of Technical Barrieres to Trade in Agricultural and Forestry Tractors,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Directive 74/347/EEC is hereby amended as follows:    1. The words "the field of vision or" are deleted from Articles 2 and 3.       2. After Article 3, the following new Article 3a is inserted:  "Article 3a  1. With effect from 1 May 1980 no Member State may, on grounds relating to the field of vision of tractors:        - refuse, in respect of a type of tractor, to grant EEC type-approval, to issue the document referred to in the last indent of Article 10 (1) of Directive 74/150/EEC, or to grant national type-approval,               - or prohibit the entry into service of tractors,                 if the field of vision of this type of tractor or of these tractors complies with the provisions of this Directive.  2. With effect from 1 October 1980 Member States:        - may no longer issue the document referred to in the last indent of Article 10 (1) of Directive 74/150/EEC in respect of a type of tractor in which the field of vision does not comply with the provisions of this Directive,  (1)OJ No L 84, 28.3.1974, p. 10. (2)OJ No L 205, 13.8.1979, p. 17. (3)OJ No L 191, 15.7.1974, p. 5. (4)OJ No L 220, 29.8.1977, p. 1.                - may refuse to grant national type-approval in respect of a type of tractor whose field of vision does not comply with the provisions of this Directive.                 3. With effect from 1 January 1983, Member States may prohibit the entry into service of any tractor whose field of vision does not comply with the provisions of this Directive."   3. The Annex is amended in accordance with the Annex to this Directive.          Article 2 Member States shall bring into force the provisions required in order to comply with the Directive not later than 30 April 1980 and shall forthwith inform the Commission thereof.   Article 3 This Directive is addressed to the Member States.     Done at Brussels, 22 November 1979.  For the Commission  Étienne DAVIGNON  Member of the Commission     ANNEX 1.4 to read as follows:  Masking effect  "Masking effect" means the chords of the sectors of the semi-circle of vision which cannot be seen owing to structural components such as roof-pillars, air intakes or exhaust stacks and the frame of the windscreen.  2.2.1.1 to read as follows:  The tractor must be placed on a horizontal surface as shown in Figure 2. On a horizontal support level with the reference point, there must be mounted two point sources of light, e.g. 2 × 150 W, 12 V, 65 mm apart and symmetrically located with respect to the reference point. The support must be rotatable at its centre point about a vertical axis passing through the reference point. For the purpose of measuring the masking effects, the support must be so aligned that the line joining the two light sources is perpendicular to the line joining the masking component and the reference point.  The silhouette (deepest shadow) overlaps projected on to the semi-circle of vision by the masking component when the light sources are switched on simultaneously or alternately must be measured in accordance with 1.4 (Figure 3).  2.2.1.2 to read as follows:  Masking effects must not exceed 700 mm.  2.2.1.3 to read as follows:  Masking effects due to adjacent structural components over 80 mm in width must be so configured that there is an interval of not less than 2 200 mm - measured as a chord of the semi-circle of vision - between the centres of two masking effects.  2.2.1.5 to read as follows:  Outside the sector of vision, masking effects exceeding 700 mm but not exceeding 1 500 mm are, however, permissible if the components causing them cannot be redesigned or relocated : on each side there may be a total of either two such masking effects, one not exceeding 700 mm and the other not exceeding 1 500 mm, or two such masking effects, neither exceeding 1 200 mm.  2.2.2.1 to read as follow:  As an alternative to the procedure set out in 2.2.1, the acceptability of individual masking effects can be determined mathematically. The requirements of 2.2.1.2, 2.2.1.3, 2.2.1.4, 2.2.1.5 and 2.2.1.6 shall apply in respect of the size, distribution and number of the masking effects.  2.5 to read as follows:  For the purpose of determining the masking effects in the sector of vision, the masking effects due to the frame of the windscreen and to any other obstacle may, in accordance with the provisions of 2.2.1.4, be considered as a single effect, provided that the distance between the outermost points of this masking effect does not exceed 700 mm.   For Figure 2, the drawing is replaced by the following drawing: >PIC FILE= "T0015652">


title: Commission Directive 2008/113/EC of 8 December 2008 amending Council Directive 91/414/EEC to include several micro-organisms as active substances (Text with EEA relevance)

text:
               9.12.2008

               EN

               Official Journal of the European Union

               L 330/6

      COMMISSION DIRECTIVE 2008/113/EC
   of 8 December 2008
   amending Council Directive 91/414/EEC to include several micro-organisms as active substances
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               Commission Regulations (EC) No 1112/2002 (2) and (EC) No 2229/2004 (3) lay down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes the active substances listed in the Annex to this Directive.

               (2)

               By Commission Regulation (EC) No 1095/2007 (4) a new Article 24b was inserted into Regulation (EC) No 2229/2004 to allow active substances for which there are clear indications that it may be expected that they do not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, to be included in Annex I to Directive 91/414/EEC without detailed scientific advice from the European Food Safety Authority (EFSA) having been sought.

               (3)

               For the active substances listed in the Annex to this Directive the Commission examined in accordance with Article 24a of Regulation (EC) No 2229/2004 the effects on human, animal health, groundwater and the environment for a range of uses proposed by the notifiers, with the conclusion that those active substances satisfy the requirements of Article 24b of Regulation (EC) No 2229/2004.

               (4)

               In accordance with Article 25(1) of Regulation (EC) No 2229/2004 the Commission has submitted draft review reports for the active substances listed in the Annex to this Directive to the Standing Committee on the Food Chain and Animal Health, for examination. Those reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 11 July 2008 in the format of the Commission review reports. In accordance with Article 25a of Regulation (EC) No 2229/2004 the Commission is to request the EFSA to deliver its view on the draft review reports by 31 December 2010 at the latest.

               (5)

               It has appeared from the various examinations made that plant protection products containing the active substances listed in the Annex to this Directive may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report. It is therefore appropriate to include in Annex I to that Directive the active substances listed in the Annex to this Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.

               (6)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

               (7)

               Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing the active substances listed in the Annex to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

               (8)

               The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (5) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives that have been adopted until now amending Annex I.

               (9)

               It is therefore appropriate to amend Directive 91/414/EEC accordingly.

               (10)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 31 October 2009 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 November 2009.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing the active substances listed in the Annex as active substances by 31 October 2009.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to the active substances listed in the Annex are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holders of the authorisations have, or have access to, dossiers satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing one of the active substances listed in the Annex as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 April 2009 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning the active substances listed in the Annex. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing one of the active substances listed in the Annex as the only active substance, where necessary, amend or withdraw the authorisation by 30 April 2014 at the latest; or

               (b)

               in the case of a product containing one of the active substances listed in the Annex as one of several active substances, where necessary, amend or withdraw the authorisation by 30 April 2014 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

         Article 4
   This Directive shall enter into force on 1 May 2009.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 8 December 2008.

            For the Commission

         Androulla VASSILIOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 168, 27.6.2002, p. 14.

      (3)  OJ L 379, 24.12.2004, p. 13.

      (4)  OJ L 246, 21.9.2007, p. 19.

      (5)  OJ L 366, 15.12.1992, p. 10.

      ANNEX
      The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:

                     No

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘199

                        Bacillus thuringiensis subsp. aizawai

                     STRAIN: ABTS-1857
                     Culture collection: No SD-1372,
                     STRAIN: GC-91
                     Culture collection: No NCTC 11821

                     Not applicable

                     No relevant impurities

                     1 May 2009

                     30 April 2019

                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Bacillus thuringiensis subsp. Aizawai ABTS-1857 (SANCO/1539/2008) and GC-91 (SANCO/1538/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     200

                        Bacillus thuringiensis subsp. israeliensis (serotype H-14)

                     STRAIN: AM65-52
                     Culture collection: No ATCC-1276

                     Not applicable

                     No relevant impurities

                     1 May 2009

                     30 April 2019

                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Bacillus thuringiensis subsp. israeliensis (serotype H-14) AM65-52 (SANCO/1540/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     201

                        Bacillus thuringiensis subsp. kurstaki

                     STRAIN: ABTS 351
                     Culture collection: No ATCC SD-1275
                     STRAIN: PB 54
                     Culture collection: No CECT 7209
                     STRAIN: SA 11
                     Culture collection: No NRRL B-30790
                     STRAIN: SA 12
                     Culture collection: No NRRL B-30791
                     STRAIN: EG 2348
                     Culture collection: No NRRL B-18208

                     Not applicable

                     No relevant impurities

                     1 May 2009

                     30 April 2019

                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Bacillus thuringiensis subsp. kurstaki ABTS 351 (SANCO/1541/2008), PB 54 (SANCO/1542/2008), SA 11, SA 12 and EG 2348 (SANCO/1543/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     202

                        Bacillus thuringiensis subsp. Tenebrionis

                     STRAIN: NB 176 (TM 14 1)
                     Culture collection: No SD-5428

                     Not applicable

                     No relevant impurities

                     1 May 2009

                     30 April 2019

                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Bacillus thuringiensis subsp. tenebrionis NB 176 (SANCO/1545/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     203

                        Beauveria bassiana

                     STRAIN: ATCC 74040
                     Culture collection: No ATCC 74040
                     STRAIN: GHA
                     Culture collection: No ATCC 74250

                     Not applicable

                     Max level of beauvericin: 5 mg/kg

                     1 May 2009

                     30 April 2019

                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Beauveria bassiana ATCC 74040 (SANCO/1546/2008) and GHA (SANCO/1547/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     204

                        Cydia pomonella Granulovirus (CpGV)

                     Not applicable

                     Contaminating micro-organisms (Bacillus cereus) < 1 × 106 CFU/g

                     1 May 2009

                     30 April 2019

                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Cydia pomonella Granulovirus (CpGV) (SANCO/1548/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     205

                        Lecanicillium muscarium

                     (formerly Verticilium lecanii)
                     STRAIN: Ve 6
                     Culture collection: No CABI (=IMI) 268317, CBS 102071, ARSEF 5128

                     Not applicable

                     No relevant impurities

                     1 May 2009

                     30 April 2019

                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Lecanicillium muscarium (formerly Verticilium lecanii) Ve 6 (SANCO/1861/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     206

                        Metarhizium anisopliae var. anisopliae

                     (formerly Metarhizium anisopliae)
                     STRAIN: BIPESCO 5/F52
                     Culture collection: No M.a. 43; No 275-86 (acronyms V275 or KVL 275); No KVL 99-112 (Ma 275 or V 275); No DSM 3884; No ATCC 90448; No ARSEF 1095

                     Not applicable

                     No relevant impurities

                     1 May 2009

                     30 April 2019

                     PART A
                     Only uses as insecticide and acaricide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Metarhizium anisopliae var. anisopliae (formerly Metarhizium anisopliae) BIPESCO 5 and F52 (SANCO/1862/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     207

                        Phlebiopsis gigantea

                     STRAIN: VRA 1835
                     Culture collection: No ATCC 90304
                     STRAIN: VRA 1984
                     Culture collection: No DSM16201
                     STRAIN: VRA 1985
                     Culture collection: No DSM 16202
                     STRAIN: VRA 1986
                     Culture collection: No DSM 16203
                     STRAIN: FOC PG B20/5
                     Culture collection: No IMI 390096
                     STRAIN: FOC PG SP log 6
                     Culture collection: No IMI 390097
                     STRAIN: FOC PG SP log 5
                     Culture collection: No IMI390098
                     STRAIN: FOC PG BU 3
                     Culture collection: No IMI 390099
                     STRAIN: FOC PG BU 4
                     Culture collection: No IMI 390100
                     STRAIN: FOC PG 410.3
                     Culture collection: No IMI 390101
                     STRAIN: FOC PG97/1062/116/1.1
                     Culture collection: No IMI 390102
                     STRAIN: FOC PG B22/SP1287/3.1
                     Culture collection: No IMI 390103
                     STRAIN: FOC PG SH 1
                     Culture collection: No IMI 390104
                     STRAIN: FOC PG B22/SP1190/3.2
                     Culture collection: No IMI 390105

                     Not applicable

                     No relevant impurities

                     1 May 2009

                     30 April 2019

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Phlebiopsis gigantea (SANCO/1863/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     208

                        Pythium oligandrum

                     STRAINS: M1
                     Culture collection No ATCC 38472

                     Not applicable

                     No relevant impurities

                     1 May 2009

                     30 April 2019

                     PART A
                     Only uses as fungicide may be authorised
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Pythium oligandrum M1 (SANCO/1864/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     209

                        Streptomyces K61 (formerly S. griseoviridis)
                     STRAIN: K61
                     Culture collection: No DSM 7206

                     Not applicable

                     No relevant impurities

                     1 May 2009

                     30 April 2019

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Streptomyces (formerly Streptomyces griseoviridis) K61 (SANCO/1865/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     210

                        Trichoderma atroviride

                     (formerly T. harzianum)
                     STRAIN: IMI 206040
                     Culture collection No IMI 206040, ATCC 20476;
                     STRAIN: T11
                     Culture collection: No
                     Spanish type culture collection CECT 20498, identical with IMI 352941

                     Not applicable

                     No relevant impurities

                     1 May 2009

                     30 April 2019

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review reports on Trichoderma atroviride (formerly T. harzianum) IMI 206040 (SANCO/1866/2008) and T-11 (SANCO/1841/2008) respectively, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     211

                        Trichoderma polysporum

                     STRAIN: Trichoderma polysporum IMI 206039
                     Culture collection No IMI 206039, ATCC 20475

                     Not applicable

                     No relevant impurities

                     1 May 2009

                     30 April 2019

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Trichoderma polysporum IMI 206039 (SANCO/1867/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     212

                        Trichoderma harzianum Rifai
                     STRAIN:

                        Trichoderma harzianum T-22;
                     Culture collection No ATCC 20847
                     STRAIN: Trichoderma harzianum ITEM 908;
                     Culture collection No CBS 118749

                     Not applicable

                     No relevant impurities

                     1 May 2009

                     30 April 2019

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review reports on Trichoderma harzianum T-22 (SANCO/1839/2008) and ITEM 908 (SANCO/1840/208) respectively and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     213

                        Trichoderma asperellum

                     (formerly T. harzianum)
                     STRAIN: ICC012
                     Culture collection No CABI CC IMI 392716
                     STRAIN: Trichoderma asperellum

                     (formerly T. viride T25) T11
                     Culture collection No CECT 20178
                     STRAIN: Trichoderma asperellum

                     (formerly T. viride TV1) TV1
                     Culture collection No MUCL 43093

                     Not applicable

                     No relevant impurities

                     1 May 2009

                     30 April 2019

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review reports on Trichoderma asperellum (formerly T. harzianum) ICC012 (SANCO/1842/2008) and Trichoderma asperellum (formerly T. viride T25 and TV1) T11 and TV1 (SANCO/1868/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     214

                        Trichoderma gamsii (formerly T. viride)
                     STRAINS:
                     ICC080
                     Culture collection No IMI CC number 392151 CABI

                     Not applicable

                     No relevant impurities

                     1 May 2009

                     30 April 2019

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Trichoderma viride (SANCO/1868/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     215

                        Verticillium albo-atrum

                     (formerly Verticillium dahliae)
                     STRAIN: Verticillium albo-atrum isolate WCS850
                     Culture collection No CBS 276.92

                     Not applicable

                     No relevant impurities

                     1 May 2009

                     30 April 2019

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Verticillium albo-atrum (formerly Verticillium dahliae) WCS850 (SANCO/1870/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.’

         (1)  Further details on identity and specification of active substance are provided in the review report.


Avis juridique important

|

32000L0054

Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC)

Official Journal L 262 , 17/10/2000 P. 0021 - 0045

Directive 2000/54/EC of the European Parliament and of the Councilof 18 September 2000on the protection of workers from risks related to exposure to biological agents at work(seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC)THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 137(2) thereof,Having regard to the proposal from the Commission,Having regard to the opinion of the Economic and Social Committee(1),After consulting the Committee of the Regions,Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),Whereas:(1) Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work (seventh individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(3) has been substantially amended on a number of occasions(4). For the sake of clarity and rationality Directive 90/679/EEC should be codified.(2) Compliance with the minimum requirements designed to guarantee a better standard of safety and health as regards the protection of workers from the risks related to exposure to biological agents at work is essential to ensure the safety and health of workers.(3) This Directive is an individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work(5). The provisions of that Directive are therefore fully applicable to the exposure of workers to biological agents, without prejudice to more stringent and/or specific provisions contained in this Directive.(4) More precise knowledge of the risks involved in exposure to biological agents can be obtained through the keeping of records.(5) The list and classification of the biological agents must be examined regularly and revised on the basis of new scientific data.(6) For a number of biological agents details additional to their classification should be given.(7) Employers must keep abreast of new developments in technology with a view to improving the protection of workers' health and safety.(8) Preventive measures should be taken for the protection of the health and safety of workers exposed to biological agent.(9) This Directive constitutes a practical aspect of the realisation of the social dimension of the internal market.(10) Pursuant to Council Decision 74/325/EEC(6) the Advisory Committee on Safety, Hygiene and Health Protection at Work should be consulted by the Commission with a view to the formulation of proposals in this field. It was so consulted over the formulation of proposals for the Council directives embodied in this Directive.(11) This Directive is without prejudice to the obligations of the Member States concerning the deadlines for transposition as set out in Annex VIII, Part B,HAVE ADOPTED THIS DIRECTIVE:CHAPTER IGENERAL PROVISIONSArticle 1Objective1. This Directive has as its aim the protection of workers against risks to their health and safety, including the prevention of such risks, arising or likely to arise from exposure to biological agents at work.It lays down particular minimum provisions in this area.2. Directive 89/391/EEC shall apply fully to the whole area referred to in paragraph 1, without prejudice to more stringent and/or specific provisions contained in this Directive.3. This Directive shall apply without prejudice to the provisions of Council Directive 90/219/EEC(7) and of Council Directive 90/220/EEC(8).Article 2DefinitionsFor the purpose of this Directive:(a) "biological agents" shall mean micro-organisms, including those which have been genetically modified, cell cultures and human endoparasites, which may be able to provoke any infection, allergy or toxicity;(b) "micro-organism" shall mean a microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material;(c) "cell culture" shall mean the in-vitro growth of cells derived from multicellular organisms."Biological agents" shall be classified into four risk groups, according to their level of risk of infection:1. group 1 biological agent means one that is unlikely to cause human disease:2. group 2 biological agent means one that can cause human disease and might be a hazard to workers; it is unlikely to spread to the community; there is usually effective prophylaxis or treatment available;3. group 3 biological agent means one that can cause severe human disease and present a serious hazard to workers; it may present a risk of spreading to the community, but there is usually effective prophylaxis or treatment available;4. group 4 biological agent means one that causes severe human disease and is a serious hazard to workers; it may present a high risk of spreading to the community; there is usually no effective prophylaxis or treatment available.Article 3Scope - Determination and assessment of risks1. This Directive shall apply to activities in which workers are or are potentially exposed to biological agents as a result of their work.2. In the case of any activity likely to involve a risk of exposure to biological agents, the nature, degree and duration of workers' exposure must be determined in order to make it possible to assess any risk to the workers' health or safety and to lay down the measures to be taken.In the case of activities involving exposure to several groups of biological agents, the risk shall be assessed on the basis of the danger presented by all hazardous biological agents present.The assessment must be renewed regularly and in any event when any change occurs in the conditions which may affect workers' exposure to biological agents.The employer must supply the competent authorities, at their request, with the information used for making the assessment.3. The assessment referred to in paragraph 2 shall be conducted on the basis of all available information including:(a) classification of biological agents which are or may be a hazard to human health, as referred to in Article 18;(b) recommendations from a competent authority which indicate that the biological agent should be controlled in order to protect workers' health when workers are or may be exposed to such a biological agent as a result of their work;(c) information on diseases which may be contracted as a result of the work of the workers;(d) potential allergenic or toxigenic effects as a result of the work of the workers;(e) knowledge of a disease from which a worker is found to be suffering and which has a direct connection with his work.Article 4Application of the various Articles in relation to assessment of risks1. If the results of the assessment referred to in Article 3 show that the exposure and/or potential exposure is to a group 1 biological agent, with no identifiable health risk to workers, Articles 5 to 17 and Article 19 shall not apply.However, point 1 of Annex VI should be observed.2. If the results of the assessment referred to in Article 3 show that the activity does not involve a deliberate intention to work with or use a biological agent but may result in the workers' being exposed to a biological agent, as in the course of the activities for which an indicative list is given in Annex I, Articles 5, 7, 8, 10, 11, 12, 13 and 14 shall apply unless the results of the assessment referred to in Article 3 show them to be unnecessary.CHAPTER IIEMPLOYERS' OBLIGATIONSArticle 5ReplacementThe employer shall avoid the use of a harmful biological agent if the nature of the activity so permits, by replacing it with a biological agent which, under its conditions of use, is not dangerous or is less dangerous to workers' health, as the case may be, in the present state of knowledge.Article 6Reduction of risks1. Where the results of the assessment referred to in Article 3 reveal a risk to workers' health or safety, workers' exposure must be prevented.2. Where this is not technically practicable, having regard to the activity and the risk assessment referred to in Article 3, the risk of exposure must be reduced to as low a level as necessary in order to protect adequately the health and safety of the workers concerned, in particular by the following measures which are to be applied in the light of the results of the assessment referred to in Article 3:(a) keeping as low as possible the number of workers exposed or likely to be exposed;(b) design of work processes and engineering control measures so as to avoid or minimise the release of biological agents into the place of work;(c) collective protection measures and/or, where exposure cannot be avoided by other means, individual protection measures;(d) hygiene measures compatible with the aim of the prevention or reduction of the accidental transfer or release of a biological agent from the workplace;(e) use of the biohazard sign depicted in Annex II and other relevant warning signs;(f) drawing up plans to deal with accidents involving biological agents;(g) testing, where it is necessary and technically possible, for the presence, outside the primary physical confinement, of biological agents used at work;(h) means for safe collection, storage and disposal of waste by workers including the use of secure and identifiable containers, after suitable treatment where appropriate;(i) arrangements for the safe handling and transport of biological agents within the workplace.Article 7Information for the competent authority1. Where the results of the assessment referred to in Article 3 reveal risk to workers' health or safety, employers shall, when requested, make available to the competent authority appropriate information on:(a) the results of the assessment;(b) the activities in which workers have been exposed or may have been exposed to biological agents;(c) the number of workers exposed;(d) the name and capabilities of the person responsible for safety and health at work;(e) the protective and preventive measures taken, including working procedures and methods;(f) an emergency plan for the protection of workers from exposure to group 3 or a group 4 biological agent which might result from a loss of physical containment.2. Employers shall inform forthwith the competent authority of any accident or incident which may have resulted in the release of a biological agent and which could cause severe human infection and/or illness.3. The list referred to in Article 11 and the medical record referred to in Article 14 shall be made available to the competent authority in cases where the undertaking ceases activity, in accordance with national laws and/or practice.Article 8Hygiene and individual protection1. Employers shall be obliged, in the case of all activities for which there is a risk to the health or safety of workers due to work with biological agents, to take appropriate measures to ensure that:(a) workers do not eat or drink in working areas where there is a risk of contamination by biological agents;(b) workers are provided with appropriate protective clothing or other appropriate special clothing;(c) workers are provided with appropriate and adequate washing and toilet facilities, which may include eye washes and/or skin antiseptics;(d) any necessary protective equipment is:- properly stored in a well-defined place,- checked and cleaned if possible before, and in any case after, each use,- is repaired, where defective, or is replaced before further use;(e) procedures are specified for taking, handling and processing samples of human or animal origin.2. Working clothes and protective equipment, including protective clothing referred to in paragraph 1, which may be contaminated by biological agents, must be removed on leaving the working area and, before taking the measures referred to in the second subparagraph, kept separately from other clothing.The employer must ensure that such clothing and protective equipment is decontaminated and cleaned or, if necessary, destroyed.3. Workers may not be charged for the cost of the measures referred to in paragraphs 1 and 2.Article 9Information and training of workers1. Appropriate measures shall be taken by the employer to ensure that workers and/or any workers' representatives in the undertaking or establishment receive sufficient and appropriate training, on the basis of all available information, in particular in the form of information and instructions, concerning:(a) potential risks to health;(b) precautions to be taken to prevent exposure;(c) hygiene requirements;(d) wearing and use of protective equipment and clothing;(e) steps to be taken by workers in the case of incidents and to prevent incidents.2. The training shall be:(a) given at the beginning of work involving contact with biological agents,(b) adapted to take account of new or changed risks, and(c) repeated periodically if necessary.Article 10Worker information in particular cases1. Employers shall provide written instructions at the workplace and, if appropriate, display notices which shall, as a minimum, include the procedure to be followed in the case of:(a) a serious accident or incident involving the handling of a biological agent;(b) handling a group 4 biological agent.2. Workers shall immediately report any accident or incident involving the handling of a biological agent to the person in charge, or to the person responsible for safety and health at work.3. Employers shall inform forthwith the workers and/or any workers' representatives of any accident or incident which may have resulted in the release of a biological agent and which could cause severe human infection and/or illness.In addition, employers shall inform the workers and/or any workers' representatives in the undertaking or establishment as quickly as possible when a serious accident or incident occurs, of the causes thereof and of the measures taken or to be taken to rectify the situation.4. Each worker shall have access to the information on the list referred to in Article 11 which relates to him personally.5. Workers and/or any workers' representatives in the undertaking or establishment shall have access to anonymous collective information.6. Employers shall provide workers and/or their representatives, at their requst, with the information provided for in Article 7(1).Article 11List of exposed workers1. Employers shall keep a list of workers exposed to group 3 and/or group 4 biological agents, indicating the type of work done and, whenever possible, the biological agent to which they have been exposed, as well as records of exposures, accidents and incidents, as appropriate.2. The list referred to in paragraph 1 shall be kept for at least 10 years following the end of exposure, in accordance with national laws and/or practice.In the case of those exposures which may result in infections:(a) with biological agents known to be capable of establishing persistent or latent infections;(b) that, in the light of present knowledge, are undiagnosable until illness develops many years later;(c) that have particularly long incubation periods before illness develops;(d) that result in illnesses which recrudesce at times over a long period despite treatment, or(e) that may have serious long-term sequelae,the list shall be kept for an appropriately longer time up to 40 years following the last known exposure.3. The doctor referred to in Article 14 and/or the competent authority for health and safety at work, and any other person responsible for health and safety at work, shall have access to the list referred to in paragraph 1.Article 12Consultation and participation of workersConsultation and participation of workers and/or their representatives in connection with matters covered by this Directive shall take place in accordance with Article 11 of Directive 89/391/EEC.Article 13Notification to the competent authority1. Prior notification shall be made to the competent authority of the use for the first time of:(a) group 2 biological agents;(b) group 3 biological agents;(c) group 4 biological agents.The notification shall be made at least 30 days before the commencement of the work.Subject to paragraph 2, prior notification shall also be made of the use for the first time of each subsequent group 4 biological agent and of any subsequent new group 3 biological agent where the employer himself provisionally classifies that biological agent.2. Laboratories providing a diagnostic service in relation to group 4 biological agents shall be required only to make an initial notification of their intention.3. Renotification must take place in any case where there are substantial changes of importance to safety or health at work to processes and/or procedures which render the notification out of date.4. The notification referred to in paragraphs 1, 2 and 3 shall include:(a) the name and address of the undertaking and/or establishment;(b) the name and capabilities of the person responsible for safety and health at work;(c) the results of the assessment referred to in Article 3;(d) the species of the biological agent;(e) the protection and preventive measures that are envisaged.CHAPTER IIIMISCELLANEOUS PROVISIONSArticle 14Health surveillance1. The Member States shall establish, in accordance with national laws and practice, arrangements for carrying out relevant health surveillance of workers for whom the results of the assessment referred to in Article 3 reveal a risk to health or safety.2. The arrangements referred to in paragraph 1 shall be such that each worker shall be able to undergo, if appropriate, relevant health surveillance:(a) prior to exposure;(b) at regular intervals thereafter.Those arrangements shall be such that it is directly possible to implement individual and occupational hygiene measures.3. The assessment referred to in Article 3 should identify those workers for whom special protective measures may be required.When necessary, effective vaccines should be made available for those workers who are not already immune to the biological agent to which they are exposed or are likely to be exposed.When employers make vaccines available, they should take account of the recommended code of practice set out in Annex VII.If a worker is found to be suffering from an infection and/or illness which is suspected to be the result of exposure, the doctor or authority responsible for health surveillance of workers shall offer such surveillance to other workers who have been similarly exposed.In that event, a reassessment of the risk of exposure shall be carried out in accordance with Article 3.4. In cases where health surveillance is carried out, an individual medical record shall be kept for at least 10 years following the end of exposure, in accordance with national laws and practice.In the special cases referred to in Article 11(2) second subparagraph, an individual medical record shall be kept for an appropriately longer time up to 40 years following the last known exposure.5. The doctor or authority responsible for health surveillance shall propose any protective or preventive measures to be taken in respect of any individual worker.6. Information and advice must be given to workers regarding any health surveillance which they may undergo following the end of exposure.7. In accordance with national laws and/or practice:(a) workers shall have access to the results of the health surveillance which concern them, and(b) the workers concerned or the employer may request a review of the results of the health surveillance.8. Practical recommendations for the health surveillance of workers are given in Annex IV.9. All cases of diseases or death identified in accordance with national laws and/or practice as resulting from occupational exposure to biological agents shall be notified to the competent authority.Article 15Health and veterinary care facilities other than diagnostic laboratories1. For the purpose of the assessment referred to in Article 3, particular attention should be paid to:(a) uncertainties about the presence of biological agents in human patients or animals and the materials and speciments taken from them;(b) the hazard represented by biological agents known or suspected to be present in human patients or animals and materials and specimens taken from them;(c) the risks posed by the nature of the work.2. Appropriate measures shall be taken in health and veterinary care facilities in order to protect the health and safety of the workers concerned.The measures to be taken shall include in particular:(a) specifying appropriate decontamination and disinfection procedures, and(b) implementing procedures enabling contaminated waste to be handled and disposed of without risk.3. In isolation facilities where there are human patients or animals who are, or who are suspected of being, infected with group 3 or group 4 biological agents, containment measures shall be selected from those in Annex V column A, in order to minimise the risk of infection.Article 16Special measures for industrial processes, laboratories and animal rooms1. The following measures must be taken in laboratories, including diagnostic laboratories, and in rooms for laboratory animals which have been deliberately infected with group 2, 3 or 4 biological agents or which are or are suspected to be carriers of such agents.(a) Laboratories carrying out work which involves the handling of group 2, 3 or 4 biological agents for research, development, teaching or diagnostic purposes shall determine the containment measures in accordance with Annex V, in order to minimise the risk of infection.(b) Following the assessment referred to in Article 3, measures shall be determined in accordance with Annex V, after fixing the physical containment level required for the biological agents according to the degree of risk.Activities involving the handling of a biological agent must be carried out:- only in working areas corresponding to at least containment level 2, for a group 2 biological agent,- only in working areas corresponding to at least containment level 3, for a group 3 biological agent,- only in working areas corresponding to at least containment level 4, for a group 4 biological agent.(c) Laboratories handling materials in respect of which there exist uncertainties about the presence of biological agents which may cause human disease but which do not have as their aim working with biological agents as such (i.e. cultivating or concentrating them) should adopt containment level 2 at least. Containment levels 3 or 4 must be used, when appropriate, where it is known or it is suspected that they are necessary, except where guidelines provided by the competent national authorities show that, in certain cases, a lower containment level is appropriate.2. The following measures concerning industrial processes using group 2, 3 or 4 biological agents must be taken:(a) The containment principles set out in the second subparagraph of paragraph 1(b) should also apply to industrial processes on the basis of the practical measures and appropriate procedures given in Annex VI.(b) In accordance with the assessment of the risk linked to the use of group 2, 3 or 4 biological agents, the competent authorities may decide on appropriate measures which must be applied to the industrial use of such biological agents.3. For all activities covered by paragraphs 1 and 2 where it has not been possible to carry out a conclusive assessment of a biological agent but concerning which it appears that the use envisaged might involve a serious health risk for workers, activities may only be carried out in workplaces where the containment level corresponds at least to level 3.Article 17Use of dataThe Commission shall have access to the use made by the competent national authorities of the information referred to in Article 14(9).Article 18Classification of biological agents1. Community classification shall be on the basis of the definitions in the second paragraph of Article 2, points 2 to 4 (groups 2 to 4).2. Pending Community classification Member States shall classify biologial agents that are or may be a hazard to human health on the basis of the definition in the second paragraph of Article 2, points 2 to 4 (groups 2 to 4).3. If the biological agent tobe assessed cannot be classified clearly in one of the groups defined in the second paragraph of Article 2, it must be classified in the highest risk group among the alternatives.Article 19AnnexesPurely technical adjustments to the Annexes in the light of technical progress, changes in international regulations or specifications and new findings in the field of biological agents shall be adopted in accordance with the procedure laid down in Article 17 of Directive 89/391/EEC.Article 20Notifying the CommissionMember States shall communicate to the Commission the provisions of national law which they adopt in the field governed by this Directive.Article 21RepealDirective 90/679/EEC, amended by the Directives referred to in Annex VIII, part A is repealed, without prejudice to the obligations of the Member States in respect of the deadlines for transposition laid down in Annex VIII, part B.References to the repealed Directive shall be construed as references to this Directive and shall be correlated in accordance with the correlation table set out in Annex IX.Article 22Entry into forceThis Directive enters into force on the twentieth day following its publication in the Official Journal of the European Communities.Article 23AddressesThis Directive is addressed to the Member States.Done at Brussels, 18 September 2000.For the European ParliamentThe PresidentN. FontaineFor the CouncilThe PresidentH. Védrine(1) OJ C 75, 15.3.2000, p. 15.(2) Opinion of the European Parliament of 13 June 2000 (not yet published in the Official Journal) and Council Decision of 17 July 2000.(3) OJ L 374, 31.12.1990, p. 1. Directive as last amended by Commission Directive 97/65/EC (OJ L 335, 6.12.1997, p. 17).(4) See Annex VIII, part A.(5) OJ L 183, 29.6.1989, p. 1.(6) OJ L 185, 9.7.1974, p. 15; Decision as last amended by the 1994 Act of Accession.(7) Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms (OJ L 117, 8.5.1990, p. 1). Directive as last amended by Directive 98/81/EC (OJ L 330, 5.12.1998, p. 13).(8) Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (OJ L 117, 8.5.1990, p. 15). Directive as last amended by Directive 97/35/EC (OJ L 169, 27.6.1997, p. 72).ANNEX IINDICATIVE LIST OF ACTIVITIES(Article 4(2))1. Work in food production plants.2. Work in agriculture.3. Work activities where there is contact with animals and/or products of animal origin.4. Work in healthcare, including isolation and post-mortem units.5. Work in clinical, veterinary and diagnostic laboratories, excluding diagnostic microbiological laboratories.6. Work in refuse disposal plants.7. Work in sewage purification installations.ANNEX IIBIOHAZARD SIGN(Article 6(2)(e))>PIC FILE= "L_2000262EN.002803.EPS">ANNEX IIICOMMUNITY CLASSIFICATIONArticle 2, second paragraph, and Article 18INTRODUCTORY NOTES1. In line with the scope of the Directive, only agents which are known to infect humans are to be included in the classified list.Where appropriate, indicators are given of the toxic and allergic potential of these agents.Animal and plant pathogens which are known not to affect man are excluded.In drawing up this list of classified biological agents consideration has not been given to genetically modified micro-organisms.2. The list of classified agents is based on the effect of those agents on healthy workers.No specific account is taken of particular effects on those whose susceptibility may be affected for one or other reason such as pre-existing disease, medication, compromised immunity, pregnancy or breast feeding.Additional risk to such workers should be considered as part of the risk assessment required by the Directive.In certain industrial processes, certain laboratory work or certain work with animals involving actual or potential exposure to biological agents of groups 3 or 4, any technical precautions taken must comply with Article 16 of the Directive.3. Biological agents which have not been classified for inclusion in groups 2 to 4 of the list are not implicitly classified in group 1.For agents where more than one species is known to be pathogenic to man, the list will include those species which are known to be the most frequently responsible for diseases, together with a more general reference to the fact that other species of the same genus may affect health.When a whole genus is mentioned in the classified list of biological agents, it is implicit that the species and strains known to be non-pathogenic are excluded.4. Where a strain is attenuated or has lost known virulence genes, then the containment required by the classification of its parent strain need not necessarily apply, subject to assessment appropriate for risk in the workplace.This is the case, for example, when such a strain is to be used as a product or part of a product for prophylactic or therapeutic purposes.5. The nomenclature of classified agents used to establish this list reflects and is in conformity with the latest international agreements of the taxonomy and nomenclature of agents at the time the list was prepared.6. The list of classified biological agents reflects the state of knowledge at the time that it was devised.It will be updated as soon as it no longer reflects the latest state of knowledge.7. Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.8. Certain biological agents classified in group 3 which are indicated in the appended list by two asterisks (**), may present a limited risk of infection for workers because they are not normally infectious by the airborne route.Member States shall assess the containment measures to be applied to such agents, taking account of the nature of specific activities in question and of the quantity of the agent involved, with a view to determining whether, in particular circumstances, some of these measures may be dispensed with.9. The requirements as to containment consequent on the classification of parasites apply only to stages in the life cycle of the parasite in which it is liable to be infectious to humans at the workplace.10. This list also gives a separate indication in cases where the biological agents are likely to cause allergic or toxic reactions, where an effective vaccine is available, or wher it is advisable to keep a list of exposed workers for more than 10 years.These indications are shown by the following letters:A: Possible allergic effectsD: List of workers exposed to this biological agent to be kept for more than 10 years after the end of last known exposureT: Toxin productionV: Effective vaccine availableThe application of preventive vaccination should take account of the code of practice given in Annex VII.BACTERIAand similar organismsNB:For biological agents appearing on this list, "spp." refers to other species which are known pathogens in humans.>TABLE>VIRUSES>TABLE>PARASITES>TABLE>FUNGI>TABLE>ANNEX IVPRACTICAL RECOMMENDATIONS FOR THE HEALTH SURVEILLANCE OF WORKERS(Article 14(8))1. The doctor and/or the authority responsible for the health surveillance of workers exposed to biological agents must be familiar with the exposure conditions or circumstances of each worker.2. Health surveillance of workers must be carried out in accordance with the principles and practices of occupational medicine: it must include at least the following measures:- keeping records of a worker's medical and occupational history,- a personalised assessment of the worker's state of health.- where appropriate, biological monitoring, as well as detection of early and reversible effects.Further tests may be decided on for each worker when he is the subject of health surveillance, in the light of the most recent knowledge available to occupational medicine.ANNEX VINDICATIONS CONCERNING CONTAINMENT MEASURES AND CONTAINMENT LEVELS(Articles 15(3) and 16(1)(a) and (b))Preliminary noteThe measures contained in this Annex shall be applied according to the nature of the activities, the assessment of risk to workers, and the nature of the biological agent concerned.>TABLE>ANNEX VICONTAINMENT FOR INDUSTRIAL PROCESSES(Article 4(1) and Article 16(2)(a))Group 1 biological agentsFor work with group 1 biological agents including life attenuated vaccines, the principles of good occupational safety and hygiene should be observed.Groups 2, 3 and 4 biological agentsIt may be appropriate to select and combine containment requirements from different categories below on the basis of a risk assessment related to any particular process or part of a process.>TABLE>ANNEX VIIRECOMMENDED CODE OF PRACTICE ON VACCINATION(Article 14(3))1. If the assessment referred to in Article 3(2) reveals that there is a risk to the health and safety of workers due to their exposure to biological agents for which effective vaccines exist, their employers should offer them vaccination.2. Vaccination should be carried out in accordance with national law and/or practice.Workers should be informed of the benefits and drawbacks of both vaccination and non-vaccination.3. Vaccination must be offered free of charge to workers.4. A vaccination certificate may be drawn up which should be made available to the worker concerned and, on request, to the competent authorities.ANNEX VIIIPART ARepealed Directive with its successive amendments(referred to in Article 21)Council Directive 90/679/EEC (OJ L 374, 31.12.1990, p. 1)Council Directive 93/88/EEC (OJ L 268, 29.10.1993, p. 71)Commission Directive 95/30/EC (OJ L 155, 6.7.1995, p. 41)Commission Directive 97/59/EC (OJ L 282, 15.10.1997, p. 33)Commission Directive 97/65/EC (OJ L 335, 6.12.1997, p. 17)PART BDeadlines for transposition into national law(referred to in Article 21)>TABLE>ANNEX IXCORRELATION TABLE>TABLE>


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Commission Directive 2001/31/EC of 8 May 2001 adapting to technical progress Council Directive 70/387/EEC relating to the doors of motor vehicles and their trailers (Text with EEA relevance)

Official Journal L 130 , 12/05/2001 P. 0033 - 0034

Commission Directive 2001/31/ECof 8 May 2001adapting to technical progress Council Directive 70/387/EEC relating to the doors of motor vehicles and their trailers(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to type-approval of motor vehicles and their trailers(1), as last amended by Directive 2000/40/EC of the European Parliament and of the Council(2), and in particular Article 13(2) thereof,Having regard to Council Directive 70/387/EEC of 27 July 1970 on the approximation of the laws of the Member States relating to the doors of motor vehicle and their trailers(3), as last amended by Commission Directive 98/90/EC(4), and in particular Article 3 thereof,Whereas:(1) Directive 70/387/EEC is one of the separate Directives of the EC type-approval procedure established by Directive 70/156/EEC. Consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to this Directive.(2) Directive 98/90/EC has introduced design requirements for the steps and handholds of cabs in order to improve the safety of persons entering and leaving the driver's compartment of certain heavy goods vehicles.(3) Certain cab designs already on the market cannot comply with the specific requirements introduced by Directive 98/90/EC, although their level of safety is considered equivalent. It is therefore necessary to further refine the technical requirements in order to allow such cab designs.(4) The measures provided for in this Directive are in accordance with the opinion of the Committee for the adaptation to technical progress established by Directive 70/156/EEC,HAS ADOPTED THIS DIRECTIVE:Article 1Annex III to Directive 70/387/EEC is amended in accordance with the Annex to this Directive.Article 21. With effect from 1 October 2001, Member States may not on grounds relating to vehicle doors:- refuse, in respect of a type of vehicle, to grant EC type-approval or national type-approval, or- prohibit the sale, registration, or entry into service of vehicles,if the vehicles comply with the requirements of Directive 70/387/EEC, as amended by this Directive.2. With effect from 1 December 2001, Member States:- shall no longer grant EC type-approval, and- may refuse to grant national type-approval,for a new type of vehicle on grounds relating to vehicle doors if the requirements of Directive 70/387/EEC, as amended by this Directive, are not fulfilled.Article 31. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 September 2001 at the latest. They shall forthwith inform the Commission thereof.When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.Article 4This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities.Article 5This Directive is addressed to the Member States.Done at Brussels, 8 May 2001.For the CommissionErkki LiikanenMember of the Commission(1) OJ L 42, 23.2.1970, p. 1.(2) OJ L 203, 10.8.2000, p. 9.(3) OJ L 176, 10.8.1970, p. 5.(4) OJ L 337, 12.12.1998, p. 29.ANNEXAnnex III to Directive 70/387/EEC is amended as follows: 1. The following sentence is added to item 1.2: "The last requirement shall not apply to the distance between the uppermost step and the cab floor."2. The seventh indent in item 1.3 is replaced by the following: "- Longitudinal overlap (J) between two subsequent steps in the same flight, or between the uppermost step and the cab floor ... 200 mm."3. The introductory phrase of item 2.2.3 is replaced by the following: "In addition, the minimum distance (P) of the upper edge of the handrail(s) or handholds or equivalent holding devices from the floor of the driver's compartment shall be: ..."