CELEX: 51990PC0492
Language: en
Date: 1990-11-09
Title: PROPOSAL FOR A COUNCIL DIRECTIVE AMENDING DIRECTIVE 64/432/EEC AS REGARDS THE DIAGNOSIS OF BOVINE BRUCELLOSIS AND ENZOOTIC BOVINE LEUKOSIS

IIP COMMISSION OF THE EUROPEAN COMMUNITIES
                                           COM(90)492  f inal
 mm
                                           Brussels, 9  November 1990
H I
                              Proposal for a
                            COUNCIL DIRECTIVE
        amending Directive 64/432/EEC as regards the diagnosis of
             bovine brucellosis and enzootic bovine leukosis
                      (presented by the Commission)
 ---pagebreak---                                     - 2 -
                           EXPLANATORY MEMORANDUM
Recent advances in Scientific knowledge have allowed for the development of
new tests (ELISA) for the diagnosis and control of bovine brucellosis and
for the adaptation of tests for the detection of enzootic bovine leukosis.
A scientific group (Brucellosis uniformity antigen group) have studied the
matter and have carried out a number of    international scientific trials,
resulting from which recommedations have been made to Incorporate the ELISA
as  an  alternative  for  milk  tests  for  the  maintenance of   officially
brucellosis free herds as well as individual blood samples.
The attached is designed to accomplish the abovementioned objectives.
There are no financial repercussions on the Community budget  involved.
 ---pagebreak---                                        - 3 -
                                  Proposal for a
                                COUNCIL DIRECTIVE
          amending Directive 64/432/EEC as regards the diagnosis of
               bovine brucellosis and enzootic bovine leukosis
THE COUNCIL Of THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community,
and in particular Article 43,
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/EEC  of  26 June  1964 on   animal health
problems affecting     Intra-Communlty  trade  In bovine animals and swine* 1 ),
as  last  amended   by  Directive  90/422/EEC* 2 ), lays down  the methods  for
maintaining the status of officially brucellosis free herds and enzootic
bovine leukosis free herds;
Whereas, due to new scientific knowledge and technical developments In the
diagnosis and control of bovine brucellosis and enzootic bovine leukosis,
an adjustment   of   existing Community    measures  In this  field  has proved
necessary;
(1)   OJ No 121, 29.7.1964, p. 1977/64
(2)   OJ No L 224, 18.8.1990, p. 9.
 ---pagebreak---                                     - 4 -
HAS ADOPTED THIS DIRECTIVE:
                                  Article 1
The Annexes to Directive 64/432/EEC are hereby amended in accordance with
the Annex to this Directive.
                                  Article 2
Member   States   shall  bring   into  force    the  laws,   regulations   and
administrative provisions necessary to comply with this Directive not later
than 1 January 1991. They shall forthwith inform the Commission thereof.
When Member States adopt these provisions, these shall contain a reference
to this Directive or shall be accompanied by such reference at the time of
their official   publication.  The procedure    for such  reference  shall  be
adopted by Member States.
                                  Article 3
This Directive is addressed to the Member States.
Done at Brussels,
                                            For the CounciI,
 ---pagebreak---                                          - 5-
                                         oHrifcÀ,
t. Annex A, 11.A.1.(c)(ii) is replaced by the following:
      (il)   are checked      annually    to establish      that   brucellosis    Is not
             present   by   three    ring    tests or milk      EL ISA carried   out  at
              intervals of at least three months or two ring tests or milk
             EL ISA  at   an    interval     of    at  least   three   months   and  one
             serological test (sero-agglutination test or buffered brucella
             antigen test or plasma agglutination test or plasma ring test
             or micro-agglutination test or individual blood ELISA) carried
             out at not less than six weeks after the second ring test or
             milk ELISA. If ring tests or milk ELISA are not carried out,
             two serological       tests    (sero-agglutiantIon      test  or   buffered
             brucella antigen test or plasma agglutination test or plasma
             ring   test   or   micro-agglutination        test  or   individual   blood
             ELISA) shall be carried out each year at Intervals of at least
             three months and not more than six months.
             Where,   in a Member       States or      region   thereof   in which   all
             bovine   herds    are subject        to official   operations    to  combat
             brucellosis, not more than 1% of bovine herds are Infected, it
             shall be sufficient to carry out each year two ring tests or
             two milk ELISA at an Interval of at least threee months, or
             one   serological     test    (sero-agglutination       test  or   buffered
             brucella antigen test or plasma-agglutination test or plasma-
             ring   test or micro-agglutination           tests or    individual   blood
             ELISA).
             Where ring tests are carried out on bulk tanks, the number of
             tests   referred    to   In the preceding        subparagraphs    shall  be
             doubled and the intervals between the tests shall be halved."
2. The following point shall be added to Annex C:
      "H.    The ELISA for brucellosis as described under Annex G"
 ---pagebreak---                                    - 6
3. In Annex G:
      a)     The following words shall be added to the title:
             "and brucellosls"
      b)     Point C is replaced by the following:
             "C.   Enzyme-linked immunosorbent assay (ELISA) for enzootic
                   bovine leukosis and bovine brucellosis.
                   1.    For the ELISA method, the materials and reagents
                         to be used are as follows:
                         (a)   solid  phase microplates, cuvettes       or  any
                               other sol id phase;
                         (b)   the antigen Is fixed to the solid phase with
                               or   without   the   aid  of   polyclonal     or
                               monoclonal catching antibodies,      if antigen
                               is coated directly to the solid phase all
                               test samples giving positive reactions have
                               to be retested against control       antigen in
                               the case of     E.B.L.. The   control    antigen
                               should be identical    to the antigen except
                               for   the   B.L.V.   antigens.    If    catching
                               antibodies are coated to the solid phase the
                               antibodies must not react to other antigens
                               other than B.L.V. or brucellosis antigens;
                         (c)   the biological fluid to be tested;
                         (d)   a   corresponding    positive   and     negative
                               control ;
                         (e)   conjugate;
 ---pagebreak---               - 7-
   (f)   a substrate adapted to the enzyme used;
   (g)   a stopping solution, if necessary;
   (h)   solutions    for   the    dilution     of   the   test
         samples for preparations of the reagents and
         for washing;
   (1)   a    reading    system      appropriate      to    the
         substrate used.
2. Standardization and sensitivity of test:
   (a)   For enzootic bovine leukosis the sensitivity
         of the EL I SA assay must be of such a level
         that   E4   serum     is   scored     positive    when
         diluted   10   times     (serum   samples)    or   250
         times (milk samples) more than the dilution
         obtained of     individual     samples when      these
         are included in pools.
         In assays where samples (serum and milk) are
         tested Individually E4 serum diluted 1 to 10
         (In negative serum) or 1 to 250 (in negative
         milk) must be scored positive when tested in
         the same assay       dilution as used        for   the
         individual test samples.
         The   E4   serum    will    be   supplied     by   the
         National Veterinary Laboratory, Copenhagen.
   (b)   (i)    For brucellosis, bulk milk samples are
                classified     negative     if   they  give a
                reaction    less than     fifty percent of
                that given by a 1 in 10 000 dilution
 ---pagebreak---                - 8 -
                 of       the       second         International
                 Brucellosis Standard serum made up in
                 negatIve milk;
          (II)   for     brucellosis         individual       serum
                 samples     are   classified       negative     if
                 they   give    a   reaction     less    than   ten
                 percent of that given by a 1               in 200
                 dilution of      the   second     International
                 Brucellosis Standard serum made up in
                 sal I ne so I ut ion.
                 The brucellosis ELISA standards shall
                 be as specified       in Annex C, A 1 and 2
                 (to be used at the dilutions indicated
                 on the label).
3. Conditions for use of the ELISA test for E.B.L.
   The ELISA method may be used on a sample of milk
   or whey taken from the ml Ik collected from a farm
   with at least 30% of dairy cows in milk.
   If use    is made    of   one   of   these    abovement ioned
   possibilities, measures must           be   taken    to ensure
   that the samples taken can be identified with the
   animals from which the milk or sera examined were
   taken.
   If one of    the samples scores positive,             the herd
   must  remain    under   official     supervision       until   a
   negative result has been recorded for at least two
   individual    tests     carried     out,     at    a    minimum
   Interval of four months, on all cattle aged more
   than    six    months,      In    accordance       with      the
   abovementioned provisions and In a laboratory that
   is directly    supervised by a        laboratory     mentioned
   in point A."
 ---pagebreak---                                                                              T»*k * o r c e PME
              XOMMTITIVENgSS AND EMPLOYMENT IMPACT STATEMENT
                      Ii iI —              •
                                           • ••
                                              ——y y— — « •«••
                                                           •     i i— — —— ^ ^ —— ««
I.    what ic the sj'.n reason fur Introducing the measure ?
       Tu use advanced technology to diaonose ch" *•»***
II.   Features nf i.K« businesses in Question. Ill particular :
      <*> »rt there many SMEs ?
                                      NO
     •<b) Are Uiey cnnt.irnirated in region* which at >• -.
           i. eligible tor regional airl in the Member atotcs ?
           H . eligible under ihp €*0F ?
III.   Whet direct obligations does this neesure t«pos« on business** 1
      -NONE
IV.    What indirect obligation* are locel authorities LikvLy to Impott                         , • '!";1
       on businesses ?
                                         NONb
                                                                                                      n
V.     Arr Tti«r« any special Measures in rrKpeec of SiMEs 7 Please specify. • -
                                          WO                                                     •"'"';.
Vi„    What is th* ;.ik»ly effect on :
        (a) the competitiveness of businesses ?
                                           NONE
        (b> «mployment 7
                                       •. none
VII.    Have both sides of industry been consulted 1
        Pl*<*i» indicate ir>e"»r opinions.           m 0 t necessary
 ---pagebreak---  ---pagebreak---                                                                                 ISSN 0254-1475
                                                                 COM(90) 492 final
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