CELEX: 51979PC0509
Language: en
Date: 1979-10-02
Title: Proposal for a COUNCIL DIRECTIVE amending Directive 64/432/EEC as regards tuberculosis and brucellosis (submitted to the Council by the Commission)

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COM (79) 509
Vol. 1979/0173
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                                                COM(79 ) 509 final .
                                                                Brussels . 2 October 1979
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                             Proposai' rfôr^A^
                            COUNCIL DIRECTIVE
               amending Directive 64 / 432 / EEC as regards
                      tuberculosis and brucellosis
            ( submitted to the Council by the Commission )
 C0M(79 ) 509 final .
 ---pagebreak---                                EXPLANATORY NOTE
By virtue of Article 104 of the Treaty of Accession, Denmark,       Ireland and
the United Kingdom were authorized to maintain for an interim       period, until
the end of 1977, their national rules for declaring a herd of       cattle
officially free of tuberculosis or free of brucellosis, these       derogations
were subsequently prolonged until the end of 1979 .
On the same basis certain derogations from existing Community provisions
were granted , to allow for the maintenance of traditional exports of cattle
from Ireland and the United Kingdom .
The limiting factors to the dismantling of these derogations were technical
problems involving primarily tuberculins and castrates ; these technical
problems have now been solved thus allowing for harmonization to take
place .
The attached proposals allow for a reduction in the amount of routine
tuberculosis testing in those regions of the Community where the disease
has virtually disappeared, thus reducing the cost and easing trade in
bovine animals .
Derogations concerning bovine animals intended for meat production and
which are under 30 months of age that were allowed for in the original
Council Directive ( 64/ 432 / EEC Art . 7.I.C ), are prolonged for a further two
years , that is until the completion of the Community accelerated anti-
brucellosis campaign .
It is additionally proposed to suppress the requirement to test for bru­
cellosis animals intended for meat production and which are under 30 days
of age because the test below this age is insufficiently precise .
 ---pagebreak---                                         f?epeeal f©p g
                                       CounciL Directive
         amending Directive 64 / 432 / EEC as regards tuberculosis and brucellosis
THE COUNCIL OF 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 bovine tuberculosis has virtually disappeared from certain regions of the
Community and whereas it is necessary to reduce the cost of routine testing for
tuberculosis in those regions ;
Whereas , in order to reduce the time taken to reestablish the status of "officially
tuberculosi s-f ree " as regards those herds in which tuberculosis has been found,
the necessary methods of control must be adopted ;
Whereas under Article 104 ( 3 ) of the Act of Accession, Denmark, Ireland and the
United Kingdom were authorized to retain, until 31 December 1977, their national
provisions for declaring a herd of cattle officially free of tuberculosis or free
of brucellosis; whereas these authorizations were extended on three occasions ^ ^
in the case of tuberculosis or, in the case of Ireland and the United Kingdom , on
two occasions ^ ^ ^ relating to brucellosis freedom within the meaning of Article 2
of Council Directive 64 / 432 / EEC       , as last amended by
Whereas these derogations were instituted and extended , in view of the time
required to provide solutions to basic technical problems ;
Whereas , for the same reason and in order not to interrupt the traditional trade in           :
live animals between Ireland and the United Kingdom , it was necessary to prolong
for the same period certain special derogations granted in respect of such trade;
Whereas these basic technical problems have now been solved, thus allowing for
certain technical amendments to Directive 64 / 432 / EEC in order that the
abovementioned derogation will no longer be necessary;
Whereas, in order to facilitate certain trade in bovine animals and until such time
as the Community accelerated disease programme is completed, it is necessary to
amend and to prolong certain derogations relating to brucellosis which were
provided for in Directive 64 /432 / EEC Article 7<1)(C >;
HAS ADOPTED THIS DIRECTIVE :
 ( 1 ) 0J No L 15 , 19.01.1978, p . 32              (3 ) OJ No L 158 , 26.06.1979 , p . 17
 (2 ) 0J No L 29, 03.02.1979, p . 27                ( 4 ) 0J No 121 , 29.7.1964, p . 1977 / 64
                                                    ( 5 ) 0J No
 ---pagebreak---                                           - a -
                                        Article 1
Directive 64 / 432 / EEC is hereby amended as follows :
1.   The following paragraph shall be added to Article 3 :
" 14 .     By way of derogation from Annex A ( l)(b ) it may be decided , under the
           procedure laid down in Article 12 , that in a Member State or region
           thereof where at least 99.8% of the bovine herds have been declared
           officially tuberculosis free within the meaning of Article 2(d ) for
           at least 10 years , and where for at least 6 years bovine tuberculosis
           has not been recorded on an annual basis in more that 1 herd per
           10 000 herds in that Member State or region , it being understood that
           all bovine animals reacting to a tuberculin test and all bovine animals
           slaughtered within that Member State or region must have been submitted
           to a post mortem examination by an official veterinarian and if necessary
           a bacteriological examination , the inspections for determining whether
           this status is to be preserved may be carried out in a manner and in
           regions to be decided under the same procedure .
           If one of the conditions provided for in the first subparagraph
           ceases to be fulfilled , the Commission - after assessing the circum­
           stances of the recrudescence of tuberculosis - shall adopt , under
           the same procedure ,. a decision to rescind the derogation decision
           taken in respect of that Member State or region of a Member State ."
 ---pagebreak---                                                    - 3 -
2 . ( a ) In Article 7(1)(C ) in the second sentence , the words " if over 30 days
          of age " shall be inserted between the words " animals " and " must ".
    ( b ) In Article 7(1 ) CC ), in the second paragraph the date " 31 December 1979 "
          shall be replaced by " 31 December 1982 ".
3 . The following paragraph shall be added to Annex A(I ):
          If in an officially tuberculosis free bovine herd an animal is deemed
          to have reacted positively to a routine maintenance tuberculin test or
          in which a clinical case of tuberculosis has been diagnosed at routine
          post-mortem examination and subsequently confirmed by laboratory exami­
          nation in an animal coming from an officially tuberculosis free herd
          then the status " officially tuberculosis-free " must be suspended until
          such time as all of the remaining animals over six weeks of age have
          reacted negatively to at least two official intradermal tuberculin tests
          in accordance with Annex B , the first one at least two months after
          complete elimination of the infection in the herd and the second one at
          least 42 days later .
4 . ( a ) In Annex A , ( II ) ,( A ) (1 ) ( c ) in the introductory sentence the words " and
          castrated males over 30 months of age" shall be inserted after the
          words " over 12 months old ".
    ( b ) In Annex A , ( II ) ( A ) ( 2 ) ( c ), in the first sentence the words " castrated
          males need not be subjected to testing ", shall be inserted after the
          word " however ".
          In Annex A ( II ) ( A ) ( 2 ) ( d ) the following sentence shall be added at the
          end of the first paragraph " Castrated males need not be subjected to
          premovement testing ".
    ( c)  In Annex A(II)(A ) ( 3)(c )          in the first sentence the words " and castrated
          males over 30 months of age " shall be inserted after the words " over
          12 months old ".
5 . Annex B shall be replaced by the Annex to this Directive .
Done at Brussels ,                                                  For the Council
                                                                    The President
 ---pagebreak---                                                                            ANNEX
                                  " ANNEX B ( 5 )
           STANDARDS FOR THE MANUFACTURE AND USE OF BOVINE AND AVIAN TUBERCULINS
1. Officially supervised tuberculin tests must be carried out with PPD or
   HCSM tuberculins .
2. Manufacturers' working standards for the control of bovine PPD
   and HCSM tuberculins must be calibrated in Community
   tuberculin units ( CTU) following biological assay against the
   appropriate EEC standard tuberculin in tuberculous cattle
   and in guinea-pigs .
3. Manufacturers' working standards for the control of avian
   tuberculins must be calibrated in international units following
   biological assay against the EEC standard for PPD of Avian Tuberculin .
4. The EEC standard for PPD of Bovine Tuberculin is that supplied by the
   Centraal Diergeneeskundig Instituut , Afdeling Rotterdam ,     Netherlands.
5. The EEC standard for Bovine HCSM Tuberculin is that supplied by the
   Institut Pasteur , Paris , France .
6. The EEC standard for Avian Tuberculin is that supplied by the Central
   Veterinary Laboratory , Weybridge , Surrey , England .
7. Bovine tuberculins must be prepared with one of the Mycobacterium bovis
   strains indicated below :
   (a ) AN5 ;
   (b ) Vallee ;
8. Avian tuberculins must be prepared with one of the Mycobacterium avium strains
   indicated below :
   (a)  D4ER ;
   (b ) TB56 .
9. The pH of tuberculins must be between 6.5 and 7.5 .
 ---pagebreak---                                          - § -
10 . Antimicrobial preservatives or other substances that may be added to
     a tuberculin shall have been shown , to the satisfaction of the state
     institute responsible for the official testing of the tuberculin , not
     to impair the safety and effectiveness of the product .
     The following are the maximum permitted concentrations for phenol and
     glycerol :
     (a )   phenol    - 0.5% M/v
     (b )   glycerol - 10% v/v
11 . Provided the tuberculins are stored at a temperature between 2°C and
     8°C , protected from light , they may be used up to the end of the
     following periods subsequent to the last satisfactory potency test :
     (a )   liquid PPD tuberculins : two years
            lyophilized PPD tuberculins : eight years
     (b )   HCSM tuberculins
            diluted : two years
12 . The state institutes listed below must be made responsible for the
     official testing of tuberculins in their respective countries :
     (a)    Germany :   Paul -Ehrlich- Institut , Frankfurt/Main ;
     (b )   Belgium :   Instituut voor Hygiëne en Epidemiologie , J. Wytsman-
                        straat 14 , B 1050 Brussels ;
      (c)   France :    Laboratoire National des Médicaments Vétérinaires ,
                        Fougères ;
      (d)   Grand Duchy of Luxembourg : Institute of the supplying country ;
      (e )  Italy :     Istituto Superiore di Sanità , Rome ;
      (f)   Netherlands : Centraal Diergeneeskundig Instituut , Afdeling
                             Rotterdam ;
      ( g ) Denmark : Statens Veterinaere Serumlaboratorium , Copenhagen V ;
      (h ) Ireland : Institute of the supplying country ;
      ( i ) United Kingdom : The Central Veterinary Laboratory , Weybridge ,
                                Surrey , England .
13 . Official testing must be carried out on each batch of bottled
     tuberculins ready for use .
 ---pagebreak---                                      - 6 -
14 . Tuberculins shall be tested by biological and chemical methods .
15 - Tuberculins must be sterile . Tests for sterility shall be carried out
     according to the specifications of the European Pharmacopoeia .
16 . A test for the absence of toxic or irritant properties shall be
     carried out according to the specifications of the European Pharma­
     copoeia .
17 . Tuberculins must be chemically analysed to determine the concentration
     of glycerol and/ or phenol and also the concentration of any other
     preservative which may have been added .
18 . A test of non-sensitization to tuberculin must be carried out
     according to the specifications of the European Pharmacopoeia .
19 . The potency of tuberculins must be estimated by biological methods .
     These methods must be used for HCSM and PPD tuberculins ; they are
     based on the comparison with standard tuberculins of the tuberculins
     to be tested .
 ---pagebreak---                                        - 7 -
20 . The protein content of PPD tuberculin must be estimated by the
     Kjeldahl method . The nitrogen is converted into tuberculo-protein
     content by multiplying by a factor of 6.25 .
21 . The EEC standard for Bovine HCSM has a potency of 65,000
     community tuberculin units ( CTU) per ml .  and is dispensed in
     ampoules containing 5 ml of tuberculin .
22 . The EEC standard for Bovine PPD has a potency of 50,000 Community
     tuberculin Units ( CTU) per mg . of PPD and is dispensed in the lyophilized
     state in ampoules containing 1.8 mg of PPD , i.e. 0.00002 mg PPD contains
     one community tuberculin unit of activity .
23 . The EEC standard for PPD of Avian Tuberculin has a potency of 50,000
     International Units ( IU) per mg . of the dried material of the purified
     protein derivative and is dispensed in the lyophilized state in ampoules
     containing 10 mg of PPD plus 26.3 mg of salts , i.e. 0.0000726 mg of the
     standard contains one international unit of activity .
24 . Tuberculins submitted by manufacturers for testing by the state
     institutes listed in paragraph 12 must have been tested for potency by
     biological assay against the appropriate standards as listed in
     paragraphs 2 and 3 .
25 .  (a ) Potency testing on guinea pigs
           Albino guinea-pigs weighing between 400 and 600 g must be used .
           These guinea pigs must be in good health at the time of the
           tuberculin inoculation . Not less than eight guinea-pigs shall be
           used for each assay . The assay should be made not less than one
           month after sensitization .
 ---pagebreak---                              - θ -
(aa ) For the assay of bovine tuberculins , guinea-pigs shall be
       sensitized by one of the following methods :
       (1)   the injection of heat killed Mycobacterium bovis strain
             AN5 in oil adjuvant
       (2)   the injection of living Mycobacterium bovis strain AN5
             in physiological saline
       (3)   the injection of B.C.G. vaccine .
(bb ) For the assay of avian tuberculins , guinea-pigs shall be
       sensitized by injection of 2 mg of heat-killed avian type
       tubercle bacilli suspended in 0.5 ml of sterile liquid
       paraffin or by the injection of live avian type tubercle
       bacilli in physiological saline .
       The avian type strain D4 must be used for this purpose .
( cc ) Each tuberculin under test shall be assayed against the
       appropriate standard tuberculin by an intradermal assay
       using groups of guinea-pigs suitably sensitized .
       The hair shall be clipped from both sides of each guinea-pig .
       The assay shall be carried out by comparing the reactions
       induced by a series of intracutaneous injections of doses of
       0.2 ml of dilutions of the standard tuberculin in isotonic
       buffered saline solution containing Tween 80 , 0.0005 per
       cent , with a corresponding series of injections of the
       tuberculin under test . Dilutions shall be arranged in
       geometric series , and injected into guinea-pigs according to
       a randomised Latin square design ( four sites on each side of
       an eight-point assay is used ) . The diameters of the
       reactions at each site should be measured and recorded after
       24 to 28 hours . '
 ---pagebreak---                                      - 9 -
               For each sample of tuberculin under test , an estimate of
               relative potency against the appropriate standard and its
               fiducial limits shall be made by statistical methods , using
               the diameters of the reactions and the logarithms of the
               doses as metameters .  The bovine tuberculin under test is of
               acceptable potency if its estimated potency guarantees per
               bovine dose 2000 C.T.U. 's (+ 25%) in cattle . The potency
               of each tuberculin under test shall be expressed as
               appropriate in Community tuberculin units or International Units
               per m.l .
     (b ) Potency testing on bovine animals
          Periodic potency testing of bovine tuberculins must be carried
          out on naturally or artificially infected tuberculous cattle .
          These potency tests , in groups of tuberculous cattle shall be
          carried out by intradermal four or six-point assay of the
          tuberculin under test against the appropriate standard and the
          potency of the tuberculin estimated by statsticial methods as in
          the guinea-pig assay .
26 . The following requirements shall apply to the labelling of tuberculin
     containers and packages :
     The label on the containers and the label on the package shall state :
          the name of the preparation
          for liquid preparations , the total volume in the container
          the number of Community or International Units per
          ml or per mg .
          the manufacturers name
          the batch number
          the nature and quantity of the reconstituting liquid for the
          freeze-dried preparation
 ---pagebreak---                                       - 10 -
     The label on the container or the label on the package shall state :
           the expiry date
           the conditions of storage
           the name and proportions of any added substance
           the species or the bacillus from which the tuberculin has been
          made .
27 . Community laboratories will be established for the periodic examina­
     tion of routine issue field tuberculins used in the Member States to
     ensure that the potency of each of these tuberculins is adequate in
     relation to the appropriate community standard tuberculin . These
     examinations must be carried out , in tuberculous bovines , in suitably
     sensitized guinea-pigs and by appropriate chemical tests .
     The Council acting on a proposal from the Commission shall designate
     the community laboratories before January 1 , 1984 .
     Under the procedure laid down in Article 12 , the Standing Veterinary
     Committee will nominate the tuberculins to be tested and the examina­
     tions to be carried out and may amend the list of laboratories where
                                                 t
     these examinations are to be effected .
28 . The following shall be recognized as official intradermal tuberculin
     tests  :
     (a )  The Single Intradermal Test - this test requires a single
           injection of bovine tuberculin .
     (b )  The Intradermal Comparative Test - this test requires one
           injection of bovine tuberculin and one injection of avian
           tuberculin given simultaneously .
29 . The dose of tuberculin injected shall be :
     (1)   not less than 2000 C.T.U. 's of bovine tuberculin
     (2 )  not less than 2000 I.U. 's of avian tuberculin .
     The volume of each injection dose shall not exceed 0.2 ml .
 ---pagebreak---                                        - 11 -
30 . Tuberculin tests shall be carried out by injecting tuberculin(s ) into
     the skin of the neck . The injection sites shall be situated at the
     border of the anterior and middle thirds of the neck .      When both avian
     and bovine tuberculins are injected in the same animal , the site for
     injection of avian tuberculins shall be about 10 cm from the crest of
     the neck and the site for the injection of bovine tuberculin about
     12.5 cm lower on a line roughly parallel with the line of the shoulder
     or on different sides of the neck particularly in young animals in
     which there is not room to separate the sites sufficiently on one side
     of the neck , one injection shall be made on each side of the neck at
     identical sites in the centre of the middle third of the neck .
31 . The technique of tuberculin testing and interpretation of reactions
     shall be as follows :
     (a )  Technique :
           Injection sites shall be clipped and cleansed . A fold of skin
           within each clipped area shall be taken between the forefinger
           and thumb and measured with a calipers and recorded . A short sterile
           needle , bevel edge outwards , with graduated syringe charged with
           tuberculin attached , shall be inserted obliquely into the deeper
           layers of the skin . The dose of tuberculin shall then be injected .
           A correct injection shall be confirmed by palpating a small pea-
           like swelling at each site of injection . The skin-fold thickness
           of each injection site shall be remeasured 72 hrs after
           injection and recorded .
      (b ) Interpretation of reactions :
           The interpretation of reactions shall be based on clinical observations
           and the recorded increase(s ) in skin-fold thickness at the sites of
           injection 72 hrs after injection of tuberculin(s ) .
           (ba ) Negative reaction : If only limited swelling is observed ,
                 with an increase of not more than 2 mm in the thickness of
                 the fold of skin without clinical signs such as diffuse or
                 extensive oedema , exudation , necrosis ; pain or inflammation
                 of the lymphatic ducts in that region or of the lymph nodes .
 ---pagebreak---                                         - 12 -
           ( bb ) Inconclusive reaction - if no clinical signs such as
                  mentioned in (ba ) are observed and if the increase in skin-
                  fold thickness is more than 2 mm and less than 4 mm then
                  this reaction may be considered as being inconclusive .
           (be ) Positive reaction : If clinical signs such as mentioned in
                  (ba ) are observed or there is an increase of 4 mm or more in
                  the thickness of the fold of skin at the injection site .
32 . The Interpretation of official intradermal tuberculin tests shall be
     as follows :
     (a)   Single Intradermal Test
           Positive :        A positive bovine reaction as defined in paragraph
                             31 (bc )
           Inconclusive : An inconclusive reaction as defined in paragraph
                             31 (bb )
           Negative :        A negative bovine reaction as defined in paragraph
                             31 (ba )
           ( aa ) Animals inconclusive to the single intradermal test
                  shall be subjected to another test after an interval of 42
                  days . Animals which are not negative to this second test
                  shall be deemed to be positive to the test .
                  Animals positive to the single intradermal test may be
                  subjected to an intradermal comparative test .
      (b ) Intradermal Comparative Test
            (ba ) For the establishment and maintenance of officially
                  tuberculosis free herds the interpretation of the test shall
                  be as follows :
                  Positive :      A positive bovine reaction and more than
                                  4 mm greater than the avian reaction or the
                                  presence of clinical signs .
                   Inconclusive : A positive bovine reaction and from 1 to 4 mm
                                  greater than the avian reaction and the absence
                                  of clinical signs
                  Negative :      A negative bovine reaction
                                            or
                                  a positive bovine reaction but equal to or
                                  less than a positive avian reaction and the absence
                                  of clinical signs in both cases .
 ---pagebreak---                                    - 13 -
            Animals inconclusive to the intradermal comparative test
            shall be subjected to another test after an interval of 42
            days . Animals which are not negative to this second test
            shall be deemed to be positive to the test .
      (bb ) Animals destined for intra-community trade must be subjected
            to a single intradermal test within 30 days prior to
            movement , any animal which shows an increase in skin-fold
            thickness greater than 2 mm or the presence of clinical signs
            must not be entered into intra-community trade .
( c ) The qualification of official tuberculosis herd freedom must be
      suspended until such time as the status of the following animals
      is resolved :
      (1)   Animals which have been deemed to be inconclusive to the
            single intradermal tuberculin test .
      (2)   Animals which have been deemed to be positive to the single
            intradermal tuberculin test but are awaiting retest with
            an intradermal comparative test .
      (3)   Animals which have been deemed to be inconclusive to the
            intradermal comparative test .