CELEX: 51987PC0594
Language: en
Date: 1987-11-27
Title: Proposal for a COUNCIL DIRECTIVE amending Directive 64/432/EEC and revoking Directive 80/1102/EEC as regards the arrangements in relation to enzootic bovine leukosis (submitted by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (87) 594
Vol. 1987/0288
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                                COM(87 ) 594 final
                                               Brussels , 27 November 1987
                                      Proposai for a
                                    COUNCIL DIRECTIVE
        amending Directive 64 / 432 / EEC and revoking Directive 80 / 1102 / EEC
      as regards the arrangements in relation to enzootic bovine leukosis
                          ( submitted b y the Commission )
                   ;o 1 n
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                                   /
C0M(87 ) 594 final
 ---pagebreak---                                                                             <?   - i7 H
                                 Explanatory Memorandum
Council Directive 80 / 1102 / EEC and 85 / 571 /EEC , which amends Council Directive
64 / 432 / EEC , lays down the health guarantees regarding enzootic bovine leukosis
( E.B.L. ) when bovine animals are entered into intra-Community trade . These
health measures have been in effect for nearly seven years and , in general the
risk of disease spreading has been greatly reduced and the measures themselves
do not cause too much difficulties in trade .         Some adjustments to these
measures have been made .      A new screening test has been added to the
legislation .
In order to clarify the rules applicable , it is necessary to consolidate the
dispositions in relation to E.B.L.       These dispositions will be applicable up
to 31 December 1991 .      It will be necessary , by this date to review the
situation taking account of the exingencies for establishing the internal
market .
 ---pagebreak---                                                   PROPOSAL
                                               for a
                                        Council Directive
                               amending Directive 64/432 / EEC
                               as regards the arrangements in
                            relation to enzootic bovine leukosis
THE COUNCIL OF THE EUROPEAN COMMUNITIES ,
Having regard to the Treaty establishing the European Economic Community , arwfc
in particular Articles 43 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 / EEC of 26 June 1964 , on animal health
measures affecting intra-Community trade in bovine animals and swine ^ as
                                               (2)
last amended by Directive 87 / 489 / EEC            lays down common health guarantees
as applicable to bovine animals intended for intra-Community trade ; whereas
                                                                      (3)
that Directive has been amended by Directives 80 / 1102 / EEC             and
                 (4)
85 / 571 / EEC        in respect of enzootic bovine leukosis ;
Whereas Article 8(2 ) of Directive 64 / 432 / EEC provides for the recognition of
Member States able to give adequate guarantees as regards enzootic bovine
leukosis ; whereas , by Commission Decision 85 / 445 / EEC of 31 July 1985
                                                                                    (5)
concerning certain animal health measures with regard to bovine leukosis
(1)   OJ   No     121 , 29.07.1964 , p.   1977 / 64
(2)   OJ   No L   280 , 3.10.1987 , p.28
(3)   OJ   No  L  325 , 01.12.1980 , p.   18
(4)   0J   No  L  372 , 31.12.1985 , p.   12
(5)   OJ   No  L  260 , 02.10.1985 , p.   18
 ---pagebreak---                                            - 2  -
certain Member States were so recognised ; whereas these Member States should
continue to be so recognised , but it is also necessary to establish the
conditions for the recognition of other Member States ;
Whereas it is necessary to consolidate the legislation applicable to trade and
to take cognizance of the favourable developing situation in relation to the
disease and to implement further rules designed to govern trade for a period
of four years ; whereas these rules must be reviewed, however,  in the light of the
measures necessary for the completion of the Internal market;
Whereas Directive 80 / 1102 /EEC required Member States to implement a minimal
eradication programme , where necessary ; whereas          the requirements laid down
therein form the basis of criteria necessary for the provision of guarantees
for intra-Community trade , which requirements should therefore form part of
Directive 64 / 432 /EEC ; whereas therefore Directive 80 / 1102 /EEC can be repealed ;
Whereas it is desirable that highly valuable pure-bred bovines , as defined in
Council Directive 77 / 504 / EEC    of 25 July 1977' concerning pure-bred bovine
                     ( С \
breeding animals           that are traded should originate in enzootic bovine
leukosis “free herds',
Whereas it is necessary that bovines for breeding or production that are
intended for combining with disease~free herds should also originate in one if
they are traded ,
Whereas special health guarantees should be applicable for certain categories
of bovines intended for breeding or production to reduce the risk of spread of
enzootic bovine leukosis when these animals are entered into intra-Community
trade ;       whereas a system has been set up , on a Member State or regional
basis , to dispense with individual animal and herd tests which are some of
these health guarantees , should the disease situation warrant it*,
Whereas it is necessary to include new tests in Community legislation ,
Whereas these rules will facilitate the free movement of bovine animals in the
Community , and therefore increase their value and productivity while reducing
the risk of spread of disease *,
 ( 6 ) OJ No L 206 , 12.08.1977 , P - 8
 ---pagebreak---                                                 J)
HAS ADOPTED THIS DIRECTIVE :
                                            Article 1
Directive 64 / 432 / EEC is hereby amended as follows :
1 . In Article 3 paragraph 2 , point ( j ) is deleted .
2 . In Article 3 paragraph 3 , point ( d ) is deleted .
3 . The following Article 4c is inserted :
    " Article 4c
    A. 1 . As regards guarantees which are to be required in respect of enzootic
           bovine leukosis for certain categories of bovine animals intended Pd?-
           intra-Community trade , the following rules shall apply :
           ( a ) Bovine animals intended for breeding and production must
                 (i)     where they are over 12 months of age , have reacted
                         negatively to a serological test carried out in accordance
                         with Annex G during the 30 days before they are loaded ,
                 ( ii )  come from a herd in which no facts have been brought to the
                         notice of the official veterinarian which would lead him to
                         conclude that a case of enzootic bovine leukosis has
                         occurred within the three preceding years , and
                 ( iii ) come from a herd , the owner of which has declared that he
                         has no knowledge of such facts and has further declared in
                         writing that the animal or animals intended for
                         intra-Community trade have either been born and reared in
                         the said herd or have remained an integral part of it for
                         the previous 12 months ;
           ( b ) Pure-bred breeding bovine animals , as defined in Article 1 of
                 Directive 77 / 504 / EEC , which are intended solely for reproductive
                 purposes and are highly valuable , must satisfy the conditions of
                 paragraph ( a ) above , and must also have been born and reared in a
                 herd in which all the animals more than 24 months of age at the
                 date of the test have in the previous 24 months reacted
                 negatively to a serological test carried out in accordance with
                 Annex G ;
 ---pagebreak---                                           4
    ( c ) The additional guarantee mentioned in paragraph ( b ) above may also
          be required for bovine animals for breeding and production by
          Member States which are applying a compulsory programme for the
          eradication of enzootic bovine leukosis , providing that the said
          bovines are intended for combining with bovine herds all of whose
          animals above 24 months of age have undergone at least one
          serological test in accordance with Annex G in the preceding 24
          months .
2 . The individual animal test provided for in paragraph l(a)(i ) above shall
    not be required if the bovine animals themselves :
    ( a ) come from a herd which fulfils the guarantees mentioned in
          paragraphs 1(a ) ( ii ) and ( iii ) which has been tested in accordance
          with 1(b ) above , or
    ( b ) are male bovine animals or bullocks less than 30 months of age
          intended for meat production , provided that such animals are
          identified by a special mark when they are loaded and that the
          Member State of destination takes all measures to prevent
          contamination of indigenous herds .
3 - Countries of destination may grant to one or more exporting countries
    general authorization or authorizations restricted to specific cases
    for the introduction into their territory of female bovine animals less
    than 30 months of age intended for meat production which have not been
    subject to a serological test , provided that such animals are
    identified by a special mark when they are loaded and that             Member
    States of destination take all measures to prevent contamination of
    indigenous herds .
4 . The requirement to carry out serological testing on individual bovines
    that are intended for intra-Community trade and on their herds of
    origin , as required by paragraph 1(a ) ( i ) and 1(b ), in an exporting
    Member State or region of a Member State will be dispensed with
    provided it is justified on the basis of demonstrating an absence of
    enzootic bovine leukosis or that the prevalence of this disease is
    insignificant . Justification shall be based on the following :
 ---pagebreak---                                       _  5 _
    ( a ) over a period of 2 years a random sample of at Least 20% of the
          bovines in the national herd over 2 years of age must have
          reacted negatively to a test carried out in accordance with
          Annex G ;
    ( b ) a tumour notification identification and classification systeia.
          must have demonstrated that no lymphatic tumour was caused by
          infection with Bovine Leukaemia virus during the previous 12 _
          months ( sampling procedures must be carried out on at least 1
          lymphatic tumour per 300 000 head of live cattle in the Member
          State or region ) ; if , during the course of such testing , an anima-l
          is found to be affected with a leukotic tumour and the diagnosis,
          of enzootic bovine leukosis is confirmed , the infected animals'
          must be removed for slaughter under the supervision of the
          veterinary authorities .      The herd must remain under official
          control until such time as it has shown a negative reaction to at
          least three tests carried out at six-monthly intervals on all
          cattle over 24 months of age and in accordance with the
          requirements of Annex G in a laboratory directly supervised by a
          laboratory mentioned in Annex C ,
5 . Member States availing themselves of the possibility to dispense with
    individual animal and herd tests as provided for in paragraph ( 4 )
    above , shall submit to the Commission full details of the results
    which form the basis of such justification .
    Furthermore , not later than the 30 June , the Member State       shall
    provide evidence to the Commission on an annual basis that :
    ( a ) during the preceeding 12 months , a random sample of at least 10 ?
          of the bovines in the national herd over 2 years of age have
          reacted negatively to a test carried out in accordance with Annex
          0;
    ( b ) the conditions of paragraph ( 4)(b ) continue to be fulfilled .
6 . The Commission shall inform the other Member States when it considers
    that a Member State . has fulfilled the requirements of paragraph 4 or
    5 above .
 ---pagebreak---                                               - 6 _
    B. This Article shall apply until 31 December 1991 .
         The Commission shall submit to the Council before 31 December 1990
         proposals concerning the definitive arrangements for the completion of
         the internal market in respect of enzootic bovine leukosis .
         The Council shall take a decision on these proposals before 1 July 1991 ."
4 . In Article 7                 ( 1 ), point G is deleted .
5 . In Article 8                 ( 2 ), the last subparagraph is deleted .
6 . Article 8a is deleted .
7 . In Model I of Annex F
    a ) in the third indent of paragraph V(c ), the figure " 12 " is replaced by
         the figure " 24 ".
    b ) footnote 12 is replaced as follows :
    " 12 . These conditions are only required in the case of pure-bred breeding
         animals which are intended solely for reproduction purposes and which
         are highly valuable , or where the animals themselves are intended for
         combining with bovine herds all of whose animals above 24 months of age
         have undergone at least one serological test in a Member State applying
         a compulsory eradication programme ."
8 . The following shall be added to Annex G :
    "C. Enzyme-linked immunosorbent assay ( ELISA ) for enzootic bovine leukosis
           1 . For the ELISA method , the materials and reagents to be used are as
               follows :
               a ) solid phase microplates , cuvettes or any other solid phase
               b ) the antigen is fixed to the solid phase with or without the aid
                   of polyclonal or monoclonal catching antibodies . If antigen is
 ---pagebreak---                                    7
        coated directly to the solid phase all test samples giving
        positive reactions have to be retested against control antigen .
        The control antigen should be identical to the antigen except tor
        the BLV antigens . If catching antibodies are coated to the solict
        phase the antibodies must not react to other antigens other thsrr
        BLV antigens .
    c ) the biological fluid to be tested ( serum or milk )
    d ) a positive and negative control .
    e ) conjugate - an antibovine immunoglobulin biotinylated or enzyme
        conjugated or an anti-BLV immunoglobulin biotinylated or enzyme
        conjugated .
    f ) avidin - enzyme for assays using biotynilated immunoglobulin
        preparations .
    g ) a substrate adapted to the enzyme used
    h ) a stopping solution
    i ) buffered solutions for the dilution of the test samples for
        preparations of the reagents and for washing .
    j ) a reading system with appropriate filters corresponding to the
        substrate used .
2 . Standardisation and sensitivity of test
    The sensitivity of the ELISA assay used 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 .
 ---pagebreak---                                        _  8 _
                                     Artide 2
Directive 80 / 1102 /EEC is hereby repealed .
                                     Article 3
Member States shall bring into force the laws , regulations and administrative
provisions necessary to comply with this Directive not later than 1 January
1988 . They shall forthwith inform the Commission thereof .
                                     Artide 4
This Directive is addressed to the Member States .
Done at Brussels ,
                                                   For the Council
                                                    The President