CELEX: 51983PC0496
Language: en
Date: 1983-09-08
Title: PROPOSAL FOR A COUNCIL DIRECTIVE AMENDING DIRECTIVE 64/432/EEC AS REGARDS BRUCELLOSIS IN RESPECT OF THE BUFFERED BRUCELLA ANTIGEN TEST, THE MICRO-AGGLUTINATION TEST AND THE MILK RING TEST AS APPLIED TO SAMPLES OF MILK FROM BULK TANKS

23.9. 83                             Official Journal of the European Communities                            No C 255/3
                                                            II
                                                     (Preparatory Acts)
                                               COMMISSION
               Proposal for a Council Directive amending Directive 64/432/EEC as regards brucellosis
               in respect of the buffered brucella antigen test, the micro-agglutination test and the milk
                                 ring test as applied to samples of milk from bulk tanks
                           (Submitted by the Commission to the Council on 9 September 1983)
THE COUNCIL OF THE EUROPEAN                                      HAS ADOPTED THIS DIRECTIVE:
COMMUNITIES,
                                                                                          Article 1
Having regard to the Treaty establishing the
European Economic Community, and in particular
Article 43 thereof,                                              Directive 64/432/EEC is hereby amended as follows:
Having regard to the proposal from the Commission,               1. In Article 3 (3), subparagraph (c), the words
                                                                     'paragraph A' are added after the words 'Annex
Having regard to the opinion of the European                         C.
Parliament,
                                                                 2. In Article 3 (4), subparagraph (i), the words
Having regard to the opinion of the Economic and                     'paragraph A' are added after the words 'Annex
Social Committee,                                                    C\
Whereas Council Directive 64/432/EEC of 26 June                  3. In Article 3 (6), subparagraph (c), the words
1964 on animal health problems affecting intra-                      'paragraph A' are added after the words 'Annex
Community trade in bovine animals and swine ('), as                  C.
last amended by Directive 82/893/EEC (2), lays down
common standards on anti-brucellosis measures
applicable to animals intended for intra-Community               4. In Article 7 (1) C, the words 'paragraph A' are
trade;                                                               added after the words 'Annex C\
Whereas it is necessary to indicate precisely that the            5. In Article 7 (1) D, the words 'paragraph A' are
slow tube serum agglutination test is the test to be                  added after the words 'Annex C\
carried out on bovine animals and swine before they
 enter into intra-Community trade;
                                                                  6. In Annex A.ILA.l (c) (i):
Whereas, in order to assure continuous free trade
 within the Community of bovine animals, it is                        — in the first paragraph the words 'paragraph A'
 necessary to adapt the technical provisions of the                      are added after the words 'Annex C ,
 above Directive relating to brucellosis to take account
 of scientific progress;                                              — the second indent is replaced by the following:
 Whereas new scientific knowledge and technical                           '— the sero-agglutination tests referred to in
 developments in the diagnosis and control of bovine                         the first paragraph may be replaced by two
 brucellosis require adjustment of existing Community                         official buffered brucella antigen tests or
 measures in this field,                                                      two micro-agglutination tests carried out
                                                                              in accordance with Annex C (D) and (G).
                                                                              These tests shall also be carried out at
 O OJ No 121, 29. 7. 1964, p. 1977/64.                                        intervals of at least three months and at
  O OJ No L 378, 31. 12. 1982, p. 57.                                         most 12 months.'
 ---pagebreak--- No C 255/4                           Official Journal of the European Communities                              23. 9. 83
7. Annex A.II.A.1 (c) (ii) is replaced by the following:                 3. The antigen may be stained only with
                                                                            hematoxylin or tetrazolium; hema-
                                                                            toxylin should preferably be used.
   '(ii) are checked annually to establish that
         brucellosis is not present by three ring tests                  4. If no preservation is used then the
         carried out at intervals of at least three                         reaction test must be carried out
         months or two ring tests at an interval of at                      between 18 and 24 hours of taking the
         least three months and one serological test                        sample from the cow. If milk is to be
         (sero-agglutination test or buffered brucella                      tested later than 24 hours after sampling
         antigen test or plasma-agglutination test or                       then preservation must be used.
         plasma ring test or micro-agglutination test)                      Formalin or mercuric chloride may be
         carried out at not less than six weeks after the                   used as preservatives and if either of
         second ring test. If ring tests are not carried                    these are used the test must be carried
         out, two serological tests (sero-agglutination                     out within the following 14 days after
         test or buffered brucella antigen test or                          the day of sampling. Formalin may be
         plasma-agglutination test or plasma ring test                      added to give a final dilution in the milk
         or micro-agglutination test) shall be carried                      sample of 0,2 °/o and, in such cases, the
         out each year at intervals of at least three                       ratio between the amount of milk and
         months and not more than six months.                               the solution of formalin must be at least
                                                                            10 to 1. A solution of mercuric chloride
                                                                            may alternatively be added to give a
         Where, in a Member State or region thereof
                                                                            final dilution in the milk of 0,2 % and,
         in which all bovine herds are subject to
                                                                            in such cases, the ratio between the
         official operations to combat brucellosis, not
                                                                            amount of milk and the solution of
         more than 1 °/o of bovine herds are infected, it
                                                                            mercuric chloride must be 10 to 1.
         shall be sufficient to carry out each year two
         ring tests at an interval of at least three                     5. The reaction must be carried out using
         months, or one serological test (sero-aggluti-                     one of the following methods:
         nation test or buffered brucella antigen test or
         plasma-agglutination test or plasma ring test                      — on a column      of milk at least 25 mm
         or micro-agglutination test).'                                          high and on   a volume of milk of 1
                                                                                 ml to which   0,03 ml of one of the
                                                                                 standardized   stained antigens has
   In Annex A.II.A.2 (c), the last paragraph is                                  been added,
   replaced by the following:
                                                                            — on a column      of milk at least 25 mm
                                                                                 high and on   a volume of milk of 1
    'The sero-agglutination tests referred to in                                 ml to which   0,05 ml of one of the
    1 (c) (i), first indent, may be replaced by buffered                         standardized   stained antigens has
    brucella antigen tests carried out in accordance                             been added,
   with Annex C (D), or micro-agglutination tests
    carried out in accordance with Annex C (G).'                            — on a volume of milk of 8 ml to
                                                                                 which 0,08 ml of one of the stan-
                                                                                 dardized stained antigens has been
9. In Annex C:                                                                   added.
                                                                         6. The mixture of milk and antigens must
        paragraph C is replaced by the following:
                                                                            be incubated at 37 ° C for not less than
                                                                             45 minutes and not more than 60
        'C. Ring test                                                        minutes. The test must be assessed
                                                                             within 15 minutes of removal from the
                                                                             incubator.
              1. The ring test must be made on the
                 contents of each milk churn or on the                   7. The reaction must be assessed according
                 contents of each bulk tank from the                         to the following criteria:
                 farm.
                                                                             (a) negative reaction: coloured       milk,
                                                                                                     colourless cream;
             2. The standard antigen to be used must
                 come from one of the institutes listed in                   (b) positive reaction: milk and cream
                 paragraph A.9 (a) to (j). It is                                                     identically colour-
                 recommended that the antigens should                                                 ed or colourless
                 be standardized according to the                                                     milk and colour-
                 WHO/FAO recommendations.                                                             ed cream.'
 ---pagebreak--- 23.9.83                               Official Journal of the European Communities                            N o C 255/5
         a new paragraph G is added:                                            at least three dilutions must be prepared
                                                                                for each serum. Dilutions of suspect
         'G. Micro-agglutination test
                                                                                serum must be made in such a way that
             1. Diluents are made up of 0,85 %                                  the reading of the reaction at the
                physiological saline solution phenolized                        infection limit is made in the median
                at 0,5 % phenol and the antigen itself is                       well by comparison with positive and
                stained with safranin 0.                                        negative controls. If there is a positive
                                                                                reaction in the median well, the suspect
             2. The antigen shall be prepared as                                serum contains at least 30 IU of aggluti-
                described under points 6, 7 and 8 of                            nation per ml.'
                Annex C (A) and shall be titrated as
                described under point 5 of Annex C (A).                                    Article 2
             3. The standard serum is the same as that           Member States shall bring into force the laws, regu-
                under point 1 of Annex C (A).                    lations and administrative provisions necessary to
                                                                 comply with this Directive by 1 July 1984. They shall
             4. The standard serum must be supplied by           forthwith inform the Commission thereof.
                the Bundesgesundheitsamt, Berlin.
             5. The micro-agglutination test shall be                                      Article 3
                carried out on plates bearing wells and          This Directive is addressed to the Member States.
               Recommendation for a Council Regulation on the conclusion of a Protocol on financial
               and technical cooperation between the European Economic Community and the Republic
                                                         of Cyprus
                           (Submitted by the Commission to the Council on 8 September 1983)
THE COUNCIL OF THE EUROPEAN                                      Republic of Cyprus is hereby approved on behalf of
COMMUNITIES,                                                     the Community.
Having regard to the Treaty establishing the                     The text of the Protocol is attached to this Regu-
European Economic Community, and in particular                   lation.
Article 238 thereof,
Having regard to the recommendation from                the
Commission,                                                                                Article 2
Having regard to the opinion of the              European        The President of the Council shall give the
Parliament,                                                      notification provided for in Article 21 (1) of the
                                                                 Protocol.
Whereas the Protocol on financial and technical
cooperation between the European                 Economic
Community and the Republic of Cyprus, signed on                                            Article 3
. . . , should be approved,
                                                                  This Regulation shall enter into force on the day
HAS ADOPTED THIS REGULATION:                                      following its publication in the Official Journal of the
                                                                  European Communities.
                          Article 1
The Protocol on financial and technical cooperation               This Regulation shall be binding in its entirety and
between the European Economic Community and the                   directly applicable in all Member States.