CELEX: 51977PC0287
Language: en
Date: 1977-06-23
Title: Proposal for a COUNCIL DIRECTIVE amending Directive 64/432/EEC on, as regards brucellosis, the buffered brucella antigen test, 45/20 vaccine and the inconclusive range to the serum agglutination test (submitted to the Council by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (77) 287
Vol. 1977/0099
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 ---pagebreak---        COMMISSION OF THE EUROPEAN COMMUNITIES
                                                             COM(77 ) 287 final .
                                          \
                                                             Brussels . 23 June 1977
                                                                                  \
                                          Proposal for a
                                        COUNCIL  DIRECTIVE
               amending Directive 64/432/EEC on , as regards brucellosis ,
               the "buffered "brucella antigen test , 45/20 vaccine and the
                  inconclusive range to the serum agglutination test
                      ^              ■■
                                                           ,  : )
                    ,   ( submitted to the Council by the Commission)
                                   /
                                                                              •\
C04(77) 287 final
 ---pagebreak---                            Explanatory Note
                                                     0
Sinoe the Council Directive 64/ 432/ EEC was adopted , progress in the
field of control of bovine "brucellosis has been achieved in many a.reas ,
both in the field of prophylaxis and in diagnosis .    Member States have
consequently introduced modernised methods in their national brucellosis
control programmes .    This means that there is now a discrepancy between
the methods used in relation to intra-Community trade , as compared with
the control of national herds .
                                                                           »
As Community provisions aim at full harmonisation of control procedures ,
it is intended to delete these discrepancies by the introduction of the
diagnostic procedures (buffered brucella antigen test ), the new vaccine
 ( 45/20 ) and an improved evaluation procedure for the serum agglutination
test .
 ---pagebreak---                          COUNCIL DIRECTIVE
                            of
             amending          Directive 64/432/EEC on , as
             regards brucellosis , the buffered brucella
             antigen test , 45/ 20 vaccine and the
             inconclusive range to the serum agglutination
                                 test
 THE COUNCIL OP THE EUROPEAN COMMUNITIES ,
 Having regard to the Treaty establishing the European Economic Community
 and in particular Articles 43 and 100 thereof ,
 Having regard to the proposal from the Commission ,          ,
 Having regard to the Opinion of the European Parliament ,
 Having regard to the Opinion of the Economic and Social Committee ,
 Whereas Council Directive 64/432/feBC of 26 June 1964 on animal health problems
 affecting intra-Community trade in bovine animals and swine^ , as last amended
 by Directive 77/98/EEC jf 21 Dtjember 1976 , 1.3ys down common standards on
 anti-brucellosis measures applicable to.- animals -.intended for intra-Community
 trade :
       »
                  •                   «
 Whereas equivalent measures for the diagnosis and control of bovine brucellosis
 are , by w&y of derogation , 'still applicable in the new Member States ; whereas
 in order to assure the continuous free tradt within the Community       of bovines
 and swine , it is necessary to adapt the technical provisions of the      above
 Directive relating to brucellosis to take account of this situation ;
 Whereas , due to new scientific knowledge and technical developments . in the.
 diagnosis and control of bovine brucellosis , an adjustment of existing Community
 measures in this field has proved necessary , .
 HAS ADOPTED THIS DIRECTIVE :
OJ No 121 o-f 25.7.1964 P. 1977/ 64
OJ L 26 of 21.1.1977 P.8 !
 ---pagebreak---                                       . Article 1
 In Annex A. Chapter II under A1 , of Directive 64/432/EEXJ
   _ in (c ) . the following new subheading ( iii ) shall "be included :
                                             <A
"(iii ) Hovevor , ari officially ^rucellosis-free herd need not necesBPrily lose -
         its status , if it contains animal 3 with less thai^ 60 International Units
         to the serum agglutination test , providing that the titre of these animals
         does not exceed 10 EEC units in two complement fixation tests , carried
         out at intervals of at least sixty days * These animals Bust not be used
         in intra - Community trade .
                                      . Article 2
 In Annex A. II . A. 1.(c)(i ) the follov/ing shall be inserted at the endj
 "at the discretion of the Member Stite involved , either of the two officii 1
  sero-cgglutinttion test3 , mentioned in the first indent of this ps.rigrcph f
  m*y be replaced by a buffered brucella antigen test complying v.'ith Annex
  C , D ; the time interval between the two official tests must be rt least
  three months aid at most 12 months'*.
                                      Article 3
 In Annex         n , At 1 (cnii ) the following ^ shall replace the existing text :
 (ii ) are checked annually to establish that brucellosis is riot present by three
       ring-tests carried out at - intervals of at least three months or two ring-
       tests c.t ijn interV&l 'o'f. &t least thrfee months and one serological test
        (serum agglutination t«3t or buffered brucella antigen test )c?.rried out
       not less than six weeks softer the second ring-testi •        If ring tests are
       not carried out , two serological te3ts (serum t^glutination test or
       buffered brucella Rntigern teat ) shall be carried out eech year st rn
        interval of ajj least thr^e months and not more then six months .
        'ilhere , in a timber State? :.ll of v/hose bovine herdty are subject to offioirl
        operations to coribat brucellosis , the percentage of bovine herds infected
        is not more than i%9 it vill bQ sufficient to ccriy out each ye*r two
        ring-testa at an interval of at least three months , or one serologics.!
        test (ea agijlut in&'t ion test , or one buffered brucella mtigen testy.
 ---pagebreak---              '*  . •                 Artici® A               .
   In Annex A. XI . A. 2 (b ). between "the words "vaccine " and "or" the :
         following shall be inserted :
   •» "or With killed 45/20 adjuvant added vaccine used ®.o©®'jpdia^ ■io &
        method officially .approved in the Member Stata ."           ~
                                     Article 5
  In Annex A. IT.A.2(c ) in the second line between the words wsmimel®w
  tnd "which", the following shall be inserted ;                       -.
  "which have been vaccinate^ with live Buck 1 9 vaccine sndwe
         Annex A , II,A , 2(^2^ 8econd - paraffruph . in the first, line , between the words
  "vaccinated * end "and ** the following shell b® inserted s ' -
  "with live Buck 19 vaccine'*.
                                   • Article 7
* In Annex C the following shall be added :
  "D. The buffered brucella antigen teat .
          The buffered brucella antigen test ®ay be oarriad out uslag . on® of tiis
           following methods I        .
  (â) Manual test
     1 , The standard serum ahall be the second International Standard Anti–
          brucella abortus serum which is supplied by the Central Veterinary
           Laboratory, Waybridge , Surrey, Engl and »
" . 2. Th« antigen will be prepared without reference to the o$lX
          concentration but its sensitivity must be standardise! in relation
          to the second international i-nti-brucelle r-.bortus et»nd«,rd serum , in
          such a way that the antigen produces a positive reaction with ?
          serum dilution of 1 * 47.5 &nd ® negative reect ion with *. dilution of
     ■ ' 1,55' 'ί           "■ ""                  τ' '
  3.      The antigen shc.ll be suspended in buffered brucella antii^en diluent
       • at a pH of 3.65 - 0.05 £Jid mty hr.ve been stained by the use of Rose
          Bengal dye . The cntigejn U3ed may be mtjnufactured according to the
          instructions given in Annex A to the working paper of 20 February
          1974 (Doc . No 503/VI/74 ).
              *.
  4.      Weybridge Strein No 99 or USDA 1119 or any other strrin of equivalent
          sensitivity must be uaed for preparing the antigen .
 5.       The culture media, used for keeping the strc.in in the 1 - bor-*.tory - nd
          for producing the antigen must be such thr.t they do not encour - ge
         bacterial dissociation (3 minus R ); potato agM* medium or continuous
      ' culture methods should be used .
 ---pagebreak---                                            -4-
                 ,                         V
     6. The tintigen eh*ll J>e tested hg&inst 8 freeze-4ried known positive
          . and negative e^rt . ■ ...               *              -                          .
     7„. ®ie supervision and official control of stand,pri serum tnd antigen                    %
            shall be ct rried ovit by the official institutes listed in
            Annex C , A , 9 oP« this Directive .
     8.     The tnti gen shall be delivered reedy for use .
     9.     Ihe buffered brucella antigen test must be carried out in the *
        • following manner :
            ( a ) Place one drop ( 0.03 ml ) of antigen alongside one drop (0.03 ml )
                     of the sérum on a white plt.te .
         : (b ) Mix with an applicator stick , first in a straight line tud then •'
          ' '        in a circle of about 10-12 mm di-jneter.'       ■
            (c ) Hie plate will then be rocked with a backwards and forwards motion
                     for four minutes ( about thirty per minute ).                "         •
            (d.) Ihe test must be read in a good light ; no evidence of agglutination
                   • will be regarded as negative ; eny degree of egglutin? tion will
              * ' ■ be' regarded &s positive , unless there was obvious evidence of excess- •
               . ... ive drying round the edges .
                     Under the provisions outlined in Article 12 , the procedures for
                     carrying out the interpretp.tion of the buffered brucella tntigen
                     test may be r-.utomated.'*
   . (B ) Automated test             '
           The method must be oapable of prodttoing a result which is at least as
            sensitive and accurate as the . manual method .
                                       Article 8
Eae Member States shall bring into lorce the laws , regulations and
administrative provisions necessary to comply with this Directive on
1 January 1978 and shall forthwith inform the Commission thereof.
                                       Article 9
This Directive is addressed to the Member States .
                                                • ■                                  .
            '                                            ••
Done at Brussels                                      ' ' For the Counoil
                                                          „ The President