Proposal for a Council Directive amending Annexes A, D (Chapter I) and F of Directive 64/432/EEC on health problems affecting intra-Community trade in bovine animals and swine
Date: 1997-07-25
Institutions: European Commission
Subjects: EC Directive, cattle, health control, intra-EU trade, swine

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 25.07.1997 
COM(97) 404  final 

97/0209 (CNS) 

Proposal for a 

COUNCIL DIRECTIVE 

amending Annexes A, D (Chapter I) and F of Directive 64/43 2/EEC on health problems 

affecting  intra-Community. trade in bovine animals and swine 

(presented by the Commission) 

EXPLANATORY MEMORANDUM 

Council  Directive 64/432/EEC  of  26 June 1964  on  animal  health  problems  affecting 
intra-Community trade in bovine animals and swine1 has recently been amended, updated 
and consolidated by Directive 97/12/EC2. 

Article 16, 1(a) of the amended Directive requests the Commission to submit a proposal 
to the Council for the amendment of Annexes A, D (Chapter I) and F, in particular with 
regard to their adaption to technological and scientific  developments. The Council shall 
decide  on these proposals by  a qualified  majority  before  1  January 1998. The Member 
States  have  been  requested  for  their  observations  and  suggestions  to  amend  these 
Annexes and resulting from their replies appropriate  Commission proposals  have been 
formulated to amend these technical Annexes. 

Although not provided for, the Council is invited to consult the European Parliament on 
this proposal. 

1  OJNo  121, 29.7.1964, p.  1977/64. 

2  O J N oL  109, 25.4.1997, p, 1. 

A 

Proposal for a 

COUNCIL DIRECTIVE 

of 

amending Annexes A, D (Chapter I) and F of Directive 64/432/EEC on health problems 

affecting  intra-Community trade in bovine animals and swine 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard 

to  Council  Directive 64/432/EEC  on  health  problems  affecting 

intra-Community 
Directive 97/12/EC2 and in particular Article 16, 1(a) thereof, 

in  bovine  animals  and  swine1,  as 

trade 

last  amended  by 

Having regard to the proposal from the Commission3, 

Having regard to the opinion of the European Parliament4, 

Whereas  in  Article 16 of Directive 64/432/EEC  the  Commission  has  been  requested  to 

make  proposals  to  amend  Annexes A,  D  (Chapter  1)  and F  of  the  said  Directive,  in 

particular with regard to their adaption to technological developments; 

Whereas  in  the  same  Article  it  is  stipulated  that  the  Council  shall  decide  on  these 

proposals by a qualified majority before  1  January 1998; 

Whereas  in  recent  times  the  development  of  veterinary  administrative  procedures 

regarding  herd  management,  animal  movement  control,  animal  identification  and 

information  handling  in relation  to  disease  control  requires  amendments  to  be  made  to 

certain annexes of this Directive; 

HAS ADOPTED THIS DIRECTIVE: 

1  OJ No 121, 29.7.1964, p. 1977/64. 

2  OJNoL109, 2-5.4.1997, p. 1. 

3  OJNoC... 

4  OJNoC... 

1Uo 

Article 1 

Annexes A,  D  (Chapter I)  and F  of  Directive 64/432/EEC  are  hereby  replaced  by  the 

Annexes to this Directive. 

Article 2 

1.  Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative 

provisions  necessary  to  comply  with  this  Directive  not  later  than  1 January  1998. 

They shall forthwith  inform the Commission thereof. 

When  Member  States  adopt  these  measures,  they  shall  contain  a  reference  to  this 

Directive or shall be accompanied  by such reference  on the occasion of their  official 

publication.  The  methods  of  making  such  a  reference  shall  be  laid  down  by  the 

Member  States. 

2.  Member  States  shall  communicate  to  the  Commission  the  texts  of  the  main 

provisions of domestic law which they adopt in the field  governed by this Directive. 

Article  3 

This Directive shall enter into force on the day of its publication in the Official Journal  of 

the European  Communities. 

Article 4 

This Directive is addressed to the Member States. 

Done at Brussels, 

For the Council 

ANNEXA 

I.  Officially  tuberculosis-free  bovine herd 

1.  A bovine herd is officially  tuberculosis free if: 

(a)  all the animals are free from clinical signs of tuberculosis; 

(b)  all  the  animals  over  six  weeks  old  have  reacted  negatively  to  at  least  two 
official  intradermal  tuberculin  tests carried  out  in accordance  with  Annex B, 
the  first  six  months  after  the  elimination  of any  infection  from  the herd  and 
the  second  six  months  later  or,  where  the  herd  has  been  assembled  solely 
from  animals  that  originate  in officially  tuberculosis-free  herds, the  first  test 
shall be carried out at least 60 days after  assembly and the second shall not be 
required; 

(c)  following  the completion of the first  test referred  to  in (b), no  bovine  animal 
over  six  weeks  old  has  been  introduced  into  the  herd  unless  it  has  reacted 
negatively to an intradermal tuberculin test performed  and assessed  according 
to Annex B and carried out either in the 30 days prior to, or the 30 days  after 
the date of its introduction into the herd, in the latter case the animal(s)  must 
be isolated from the other animals of the herd until proven negative. 

This  test  shall  not  be  necessary  in  Member  States  or  regions  of  a  Member 
State  where the percentage  of bovine herds infected  with tuberculosis  is  less 
than 0,2% or if the animal originates in an officially  tuberculosis-free  herd. 

2.  A bovine herd will retain officially  tuberculosis-free  status  if: 

(a)  the conditions detailed in  1(a) and (c) continue to apply; 

(b)  all  animals  entering 
tuberculosis-free  status; 

the  holding  come 

from  herds  of  officially 

(c)  all  animals  in the  holding, with the  exception  of  calves  under  six  weeks  old 
which were born  in the holding, are subjected  to routine tuberculin testing  in 
accordance with Annex B at yearly intervals. 

However,  the  Commission,  in  accordance  with  the  procedure  in  Article  17, 
may,  for  a  Member  State  or  part  of  a  Member  State  where  all  the  bovine 
herds  are  subject  to  official  operations  to  combat  tuberculosis,  alter  the 
frequency  of the routine tests as follows: 

- 

- 

if  the  percentage  of  bovine  herds  infected  with  tuberculosis  is  not  more 
than  1%  on  average  during  the  two  most  recent  annual  supervisory 
periods,  the  interval  between  routine  herd  tests  may  be  increased  to  two 
years; 

if  the  percentage  of  infected  bovine  herds  is  not  more  than  0,2%  on 
average  during  the  two  most  recent  biennial  supervisory  periods,  the 
interval between routine tests may be increased to three years, 

- 

if  the  percentage  of  infected  bovine  herds  is  not  more  than  0,1%  on 
average  during  the  two  most  recent  supervisory  triennial  periods,  the 
interval  between  routine  tests  may  be  increased  to  four  years  and/or  the 
age  at  which  animals  have  to  undergo  these  tests  may  be  increased  to 
24 months. 

The  Commission  may  also,  in  accordance  with  Article  17,  take  a  decision 
increasing  the  frequency  of  routine  tuberculin  testing  if the  level  of  disease 
appears to have increased. 

When  a Member  State operates a system of identification  and registration  of 
bovine  animals  which  provides  for  identification  of  herds  of  origin  and 
transit, if the percentage of infected herds is not greater than 0,1% on average 
during  the  two  most  recent  control periods, it  may  dispense  with  the  annual 
tuberculin test of the herds on condition that: 

(1)  before the introduction  into the herd all the bovine animals are  subjected 

to an intradermal tuberculin test with negative results; 

(2)  all  bovine  animals  slaughtered  are  examined  for  lesions  of  tuberculosis 
and  any  such  lesions  are  submitted  to  a bacteriological  examination  for 
evidence of tuberculosis bacteria. 

3.  The officially  tuberculosis-free  status of a herd shall be suspended  if: 

(a)  the conditions detailed in 2 have hot been complied with; 

(b)  an animal is deemed to have reacted positively to a routine tuberculin test, or 
tuberculosis  has  been  diagnosed  at  routine  post-mortem 

a  case  of 
examination. 

In  these  cases,  the  status  shall  remain  suspended  until  such  time  as  all  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  carried  out  at  least  two  months  after  elimination  of the  animal  from  the 
holding and the second one at least 42 days after  the first. Disinfection  of the 
premises and utensils must take place. 

However,  if  an  animal  reacts  positively  to  a  tuberculin  test  or  is  found  at 
slaughter  to  have  lesions  suspected  of  being  tuberculous,  the  officially 
tuberculosis-free  status of the herd of origin shall be suspended. Any  positive 
reactor  animal(s)  shall  be  removed  from  the  herd  and  slaughtered  and 
appropriate  post-mortem  tests  and  laboratory  examinations  shall  be  carried 
out. 

If  the  presence  of  tuberculosis  is  confirmed,  the  officially  tuberculosis-free 
status of the herd of origin shall remain suspended until the procedures  in (b) 
above have been complied with. Tracing and checking of any herd considered 
necessary by the competent authority shall be undertaken. 

tuberculosis 

the  presence  of 

the  officially 
If 
tuberculosis-free  status of the herd of origin may be restored  following  a test 
with  negative  results,  no  less  than  60 days  after  the  removal  of  the  reactor 
animal(s), of all animals over six weeks of age. 

is  not  confirmed, 

(c)  the  herd  contains  animals  of  unresolved  status  as  described  in  Annex B, 
point 32. In this case the  status of the herd  shall  remain  suspended  until  the 
animals'  status  has  been  clarified.  Such  animals  must  be  isolated  from  the 
other animals of the-herd until their status has been  clarified. 

4.  A Member State or part of a Member State may be declared  officially  tuberculosis 
free  according  to  the procedure  laid down  in Article  17 if  it  meets  the  following 
conditions: 

(a)  the percentage of infected  bovine herds has not been more than 0,01% for  six 
consecutive  years  and  at  least  99,9%  of  the  herds  have  been  declared 
officially  tuberculosis free for 6 years; 

(b)  an identification  system making it possible to identify  the herds of origin and 

transit for each bovine animal is in existence; 

(c)  all  bovine  animals  slaughtered  must  be  subjected 

to  a  post-mortem 

examination by an official  veterinarian; 

(d)  while  such  examinations  take place; the  officially  tuberculosis  free  status  of 
the herd of origin shall be suspended. All animals which reacted positively  to 
the  test,  and  any  animals  which,  in  the  opinion  of  the  competent  authority, 
have  been  exposed  to  the  possibility  of  infection,  shall  be  slaughtered.  If 
clinical  or 
the  presence  of  bovine 
tuberculosis  the  Officially  Tuberculosis  Free  status  of  any  other  herd  which 
may  have  been  exposed  to  infection  should  be  similarly  suspended  pending 
investigation by the competent authority. 

laboratory  examinations  confirm 

5.  The  Member  state  or  part  of  a  Member  State  will 

retain  officially 

tuberculosis-free  status if: 

(a)  the conditions 4(a) to (d) continue to apply; 

(b)  when  a  case  of  tuberculosis  is  confirmed,  the  officially 

tuberculosis-free 

*_ 

status oftheherdof  origin and transit is withdrawn; 

(c)  the  officially  tuberculosis-free  status  of  herds  where  tuberculosis  has  been 

confirmed  remains withdrawn until: 

-  all  the  animals  that  have  been  deemed  to  be  infected  have  been 

slaughtered, 

-  disinfection  of the premises and utensils has taken place, 

-  all  the  remaining  bovine  animals  over  six  weeks  of  age  have  reacted 
negatively  to  at  least  two  official  intradermal  tests  in  accordance  with 
Annex B,  the- first at  least  six  months  after  the  removal  of  the  infected 
animals, the second six months after the first. 

6.  If there is evidence of a significant  change in the situation as regards  tuberculosis 
in  a  Member  State  or  part  of  a  Member  State  which  has  been  recognized  as 
tuberculosis  free,  the  Commission  may  in  accordance  with  the 
officially 
procedure  laid  down  fn  Article  17  take  a  decision  suspending  or  revoking  the 
status  and  requiring routine  tuberculin  tests  to be  carried  out  in  accordance  with 
one of the schedules in 2(c). 

II.  Officially  brucellosis-free  and brucellosis-free bovine herds 

For the purposes  of this Section  'bovine animals'  means all bovine animals with the 
exception of males castrated before the age of four months. 

1.  A bovine herd is officially  brucellosis free  if: 

(a)  it contains no bovine animals which have been vaccinated against brucellosis, 
except females which have been vaccinated at least three years previously; 

(b)  all the bovine animals have been free  from  clinical  signs of brucellosis  for  at 

least six months; 

(c)  all the bovine  animals over  12 months old have been  subjected  to  one  of the 
following  test regimes with negative results in accordance with Annex C: 

(i) 

two  serum  agglutination  tests  at  an  interval  of  more  than  three  months 
and less than  12 months; 

(ii)  three  ring  tests  at  three-monthly  intervals  followed  at  least  six  weeks 

later by a serum agglutination test; 

(iii) two  buffered  brucella  antigen  tests  at  an  interval  of  more  than  three 

months and less than  12 months; 

(iv) two  micro-agglutination  tests  at  an  interval  of  more  than  three  months 

and less than  12 months. 

2." A bovine herd will retain officially  brucellosis-free  status  if: 

(a)  one  of  the  following  test regimes  is carried  out annually  with  negative  result 

in accordance with Annex C: 

(i) 

three ring tests carried out at intervals of at least three months; 

(ii)  three milk Elisas carried out at intervals of at least three months; 

(iii) two ring tests carried  out at an interval  of at least three months  followed 
in 

later  by  a  serological 

least  six  weeks 

test  referred 

to 

at 
paragraph  13(a); 

(iv) two  milk  Elisas  carried  out  at  an  interval  of  at  least  three  months 
followed  at  least  six  weeks  later  by  a  serological  test  referred  to  in 
paragraph  13(a); 

(v)  two  serological  tests  carried  out  at  an  interval  of  at  least  three  months 

and not more than six months. 

However,  the  Commission,  in  accordance  with  the  procedure  laid  down  in 
Article  17, may, for  a Member  State or part  of a Member  State  which  is  not 
officially  brucellosis free but where all the bovine herds are subject  to  official 
operations  to  combat  brucellosis,  alter  the  frequency  of  the  routine  tests  as 
follows: 

where  not  more  than  1%  of  bovine  herds  are  infected,  it  may  be 
sufficient  to  carry  out  each  year  two  ring  tests  or two  milk  Elisas  at  an 
interval of at least three months, or one serological test, 

where  at least  99,8% of bovine herds have been recognized  as  officially 
brucellosis  free  for  at  least  four  years, the  interval  between  checks  may 
be extended to two years and the checks must be carried out using one of 
the serological tests referred  to in paragraph  13(a); 

(b)  all  bovine  animals  entering  the  herd  come  from  herds  of  officially 
brucellosis-free  status and, in the case of bovine animals over  12 months  old, 
have  shown a brucella  count of less than  30 IU of agglutination per ml when 
given  a  serum  agglutination  test  in  accordance  with  Annex C  during  the 
30 days prior to introduction into the herd. 

However,  the  serum  agglutination  test  described  in  point (b)  need  not  be 
required  in  Member  States,  or  regions  of  Member  States,  where  the 
percentage  of  bovine  herds  infected  with  brucellosis  has  not  exceeded  0,2% 
for  at  least  two  years  and  where  the  animal  comes  from  an  official 
brucellosis-free  bovine  herd  within  that  Member  State  or region  and  has  not 
during transportation come into contact with bovine animals of lesser status; 

(c)  notwithstanding point (b), bovine animals from  a brucellosis-free  bovine herd 
may  be  introduced  into  an officially  brucellosis-free  herd  if they  are  at  least 
18 months  old  and,  if  vaccinated  against  brucellosis,  the  vaccination  was 
carried out more than a year previously. 

Such  animals  must  have  shown,  in  the  30 days  prior  to  introduction,  a 
brucella count lower than 30 IU of agglutination per ml and  a negative  result 
when given a complement fixation test, both in accordance with Annex C. 

If,  however,  a  bovine  animal  from  a  brucellosis-free  herd  is  introduced  into 
an  officially  brucellosis-free  herd,  under  these  provisions,  that  herd  shall  be 
considered  to  be  brucellosis  free  for  two  years  from  the  date  on  which  the 
animal was introduced. 

3.  The officially  brucellosis-free  status of a herd may be suspended or withdrawn  if: 

(a)  the conditions detailed in paragraph  1  and 2 have not been complied with; or 

(b)  as  a  result  of  laboratory  tests  or  on  clinical  grounds  one  or  more  bovine 

animals are suspected of having brucellosis. 

If  one  or  more  bovine  animals  in  an  officially  brucellosis-free  herd  are 
suspected  of  having  brucellosis,  the  status  of  the  herd  may  be  suspended, 
rather than withdrawn,  if the animal or animals are immediately  destroyed  or 
isolated. 

Where  the  animal  has  been  destroyed,  the  suspension  may  be  lifted  if  two 
• serum  agglutination  tests,  carried  out  in  accordance  with  Annex C  on  all 
bovine  animals  in  the  herd  over  12 months  old,  show  a  count  lower  than 
30 IU  of  agglutination  per  ml.  The  first  test  shall  be  carried  out  at  least 
30 days after the removal of the animal and the second at least 60 days later. 

Where the animal has been isolated,  it may be reintroduced  into the herd  and 
the  status  of  the  herd  may  be  restored,  if  it  subsequently  shows  a  serum 
agglutination  count lower than 30 IU of agglutination per ml and has given a 
negative  result to a complement  fixation  test, these tests being  carried  out  in 
accordance with Annex C. 

Where,  as  a  result  of  laboratory  tests  or  epidemiological  investigations, 
brucella  infection  has been confirmed  in the herd, the status of the herd  shall 
not  be  restored  until  either  all bovine  animals  present  in the herd  at the  time 
of the outbreak have been slaughtered, or the herd has been subject to  30-day 
check  testing  and  all  animals  over  12 months  of  age  have  given  negative 
results  to  two  consecutive  tests.  In  the  case  of  bovine  animals  which  were 
pregnant  at  the  time  of  the  outbreak,  the  final  check  must  be  carried  out  at 
least  21 days  after  the  last  animal  pregnant  at  the  time  of  the  outbreak  has 
calved. 

4*.-A bovine  herd  is  brucellosis  free  if  it  complies  with  the  conditions  in  1(a),  (b) 

and (c), except that: 

(i)  female  bovine animals may be vaccinated: 

before  the  age  of  six  months  old  with  live  strain  19  vaccine  or  other 
vaccines approved under the procedure laid down in Article  17, or 

before  the  age  of  15 months  old  with  killed  45/20 adjuvant  vaccine 
which has been officially  inspected and recognized; 

(ii)  bovine  animals  under  30 months  old  which  have  been  vaccinated  with  live 
strain  19  vaccine  may  give  a  serum  agglutination  test  result  greater  than 
30 IU but  less than  80 IU of agglutination per millilitre provided  that,  on the 
complement fixation test, they give a result less than 30 EEC units in the case 
of  females  vaccinated  less  than  12 months  previously  or  less  than  20 EEC 
units in all other cases; 

(iii) in addition to those tests listed in  1(c), the following  test regimes will also be 

approved in order to attain brucellosis-free  status; 

(a)  two buffered  brucella antigen tests carried out at an interval  of more than 

three months and less than  12 months; 

(b)  two micro-agglutination tests carried out at an interval of more than three 
months  and  less  than  12 months  in  accordance  with  the  provisions  of 
AnnexC. 

5.  A bovine herd will retain brucellosis-free  status  if: 

(i) 

it is subject to one of the testing regimes listed in 2(a); 

(ii)  bovine animals entering the herd comply with the requirements of 2(b); or 

come  from  herds  of  brucellosis-free  status,  and  in  the  case  of  bovine 
animals  over  12 months  old,  have  shown,  in  the  30 days  prior  to 
introduction  into the herd,  less than  30 IU  of  agglutination  per  ml  when 
given  a  serum  agglutination  test  and  a  negative  result  to  a  complement 
fixation test in accordance with Annex C, or 

come  from  herds  of brucellosis-free  status, are  under  30 months  old  and 
have  been  vaccinated  with  live  strain  19  vaccine  may  give  a  serum 
agglutination  test  result  greater  than  30 IU  but  less  than  80 IU  of 
agglutination  per  millilitre  provided  that,  on  the  complement  fixation 
test,  they  give  a  result  less  than  30 EEC  units  in  the  case  of  females 
vaccinated  less  than  12 months  previously  or  less  than  20 EEC  units  in 
all other cases. 

6.  The brucellosis-free  status of a herd shall be suspended or withdrawn  if: 

- _(a)  the conditions detailed in paragraphs 4 and 5 have not been complied with; or 

(b)  as  a  result  of  laboratory  tests  or  on  clinical  grounds  one  or  more  bovine 

animals over 30 months old are suspected of having brucellosis. 

If one or more bovine  animals, over  30 months old,  in a brucellosis-free  herd  are 
suspected  of  having  brucellosis,  the  status  of  the  herd  may  be  suspended,  rather 
than withdrawn, if the animal or animals are immediately destroyed or isolated. 

Where the animal  has been destroyed,  the suspension  may  be lifted  if two  serum 
agglutination tests, carried out in accordance with Annex C on all bovine  animals 
in  the  holding  over  12 months  old,#  show  a  count  lower  than  30 IU  of 
agglutination  per  ml.  The  first  test  shall  be  carried  out  at  least  30 days  after  the 
removal of the animal and the second at least 60 days later. 

v 

Where the  animal  has been isolated,  it may be reintroduced  into the herd  and  the 
status of the herd may be restored, if it subsequently  shows a serum  agglutination 
count lower than 30 IUof agglutination per ml and has given a negative result to a 
complement  fixation  test,  these  tests  being  carried  out  in  accordance  with 
Annex C. 

, 

Where,  as  a  result  of -laboratory  tests  or  epidemiological  investigations,  brucella 
infection  has been confirmed  in a herd, the status of that herd shall not be restored 
until all bovine animals that were pregnant at the time of the outbreak  have  given 
negative  results to the  above tests, the final test having  being  carried  out  at  least 
21 days after  calving, 

7.  A region of a Member  State may be declared officially  brucellosis  free  according 

to the procedure laid down in Article  17 if it meets the following  conditions: 

(a)  no  case  of  abortion  due  to  brucella  infection  has  been  recorded  for  at  least 
three  years  and  at  least  99,8%  of  the  herd  have  been  declared  officially 
brucellosis free  for  10 years; 

(b)  an identification  system making it possible to identify  the herds of origin and 

transit for each bovine animal is in existence. 

8.  Subject  to  point 9,  a  region  declared  officially  brucellosis  free  shall  retain  this 
status  if  all  bovine  animals  over  24 months  old  are  subjected  to  either  two  ring 
tests  , two  milk  Elisa tests  or  one  serological  test  referred  to  in  paragraph  13(a), 
every  three  years. In the  event  of a positive  result  the provisions  of  point 6  shall 
apply. 

9.  A region declared officially  brucellosis free shall report the occurrence of all cases 
of  brucellosis  to  the  Commission.  The  Commission  may  according  to  the 
procedure  laid down in Article  17 propose that the status be suspended or revoked 
and  require  that  routine  brucellosis  testing  be  carried  out  in  accordance  with  one 
of the schedules in paragraph 2. 

10.  A  Member  State  may  be  declared  officially  brucellosis  free  according  to  the 

procedure  laid down in Article  17 if it meets the following  conditions: 

(a)  no  case  of  abortion  due to brucella  infection  has  been  recorded  for  at  least 
three years  and at least 99,8% of the holdings have been declared  officially 
brucellosis free  for  10 years; 

(b)  an  identification  system  making  it  possible  to  identify  the  herds  of  origin 

and transit for each bovine animal is in existence. 

10 

11.  A Member State declared officially  brucellosis free shall retain this status if: 

every bovine animal suspected of being infected with brucellosis is notified 
investigation  for 
to  the  competent  authority  and  undergoes  official 
brucellosis  comprising  at  least  two  serological  blood  tests,  including  the 
complement fixation test, and a microbiological examination of appropriate 
samples taken in the case of an abortion, 

during  the period of suspicion, which  shall continue until  negative  results 
have  been  obtained  from  the  tests  provided  for  in  the  first  indent,  the 
officially  brucellosis-free  status  of  the  herd  of  origin  or  transit  of  the 
suspected bovine shall be suspended. 

in the event of a positive result, if all of the breeding bovines have not been 
destroyed,  the  remaining  animals  must  be  subjected  to  requalification 
following the procedures referred to in paragraph 1. 

12.  A Member  State declared officially  brucellosis  free  shall report the occurrence 
of all cases of brucellosis to the Commission. The Commission may, according 
to the procedure laid down in Article 17, propose that the status be suspended or 
revoked and require that routine brucellosis testing be carried out in accordance 
with one of the schedules in paragraph 2. 

» 

13.  (a)  For the purposes of Section II, a serological tests shall mean either a serum 
agglutination  test, buffered  brucella antigen test, complement  fixation  test, 
plasma  agglutination  test,  plasma  ring  test,  micro-agglutination  test  or 
individual blood Elisa, as described in Annex C. 

(b)  Where  ring  tests  are  carried  out  on bulk  tanks, the  number  of  those tests 
referred to in this Annex shall be doubled and the intervals between the tests 
shall be halved. 

H 

ANNEXD 

CHAPTER I 

OFFICIALLY ENZOOTIC-BOVINE-LEUKOSIS-FREE  HERDS, MEMBER 
STATES AND REGIONS 

A.  Officially  enzootic-bovine-leukosis-free  herd means a herd in which: 

(i) 

there is no evidence, either clinical or as a result of a laboratory test, of any case 
of enzootic  bovine leukosis  in the herd and no such case has been confirmed  in 
the previous two years; and 

(ii)  all animals  over 24 months  of age have reacted  negatively  during the  preceding 
24 months to two tests carried  out in accordance with this Annex, at an  interval 
of at least four months; or 

(iii) it  meets  the  requirements  of  (i)  above  and  is  situated  in  an  officially 

enzootic-bovine-leukosis-free  Member State or region. 

B.  An  individual  herd  shall  retain  officially  enzootic-bovine-leukosis-free  status 

provided: 

(i) 

the condition in A(i) continues to be  fulfilled; 

(ii)  any  animals  introduced  into  the  herd  come  from  an  officially  enzootic-bovine-

leukosis-free  herd; 

(iii) all  animals  over  24 months  of age continue  to  react  negatively  to  a test  carried 

out in accordance with Chapter II at intervals of three years. 

C.  The  officially  leukosis-free  status  of  a  herd  shall  be  suspended  if  the  conditions 

detailed in B are not  fulfilled. 

D.  The  status  shall  remain  suspended  until  the  following  requirements  are  complied 

with: 

1.  If  a  single  animal  in  an  officially  enzootic-bovine-leukosis-free  herd  has  reacted 

positively to one of the tests referred  to in Chapter II: 

-(i) 

the animal which has reacted positively, and, in the case of a cow, any calf it 
may  have  produced,  must  have  left  the  herd  for  slaughter  under  the 
supervision of the veterinary  authorities; 

(ii)  the  remaining  animals  have  reacted  negatively  to  two  serological  tests  (at 
least 4 months  and  less than  12 months  apart) carried  out in accordance  with 
Chapter II three months  at least after  removal  of the positive  animal  and  any 
possible progeny thereof; 

12 

(iii) an  epidemiological  inquiry  must  be  conducted  and  the  herds  linked 
epidemiologically to the infected herd must be subjected to the measures laid 
down in (ii). 

However, the competent authority may grant a derogation from the obligation to 
slaughter  the  calf  of  an  infected  cow  where  it  was  separated  from  its  mother 
immediately  after  calving.  In  this  case,  the  calf  must  be  made  subject  to  the 
requirements provided for in  2(iii). 

2.  Where  more  than  one  animal  from  an  officially  enzootic-bovine-leukosis-free 
herd has reacted positively or where infection has otherwise been confirmed  in a 
herd: 

(i)  the  animals  which  have  reacted  positively  and,  in  the  case  of  cows,  their 
calves, must be removed for slaughter under the supervision of the veterinary 
authorities; 

(ii)  all animals in the herd aged over 24 months must react negatively to two tests 
carried out in accordance with Chapter II at an interval of at least four months 
and no more than 12 months; 

(iii) all other animals in the herd must, after  identification,  remain on the holding 
until they are aged over 24 months and have satisfied  the tests referred  to in 
(ii); 

(iv) an  epidemiological 

linked 
epidemiologically to the infected herd must be subjected to the measures laid 
down in (ii). 

inquiry  must  be  conducted,  any  herd 

However, the competent authority may grant a derogation from  the obligation to 
slaughter  the  calf  of  an  infected  cow  where  it  was  separated  from  its  mother 
immediately  after  calving.  In  this  case,  the  calf  must  be  made  subject  to  the 
requirements provided for in 2(iii). 

3.  Where  the  officially  enzootic-bovine-leukosis-free  status  of  a  herd  has  been 
suspended for any other reason, all animals in the herd aged over 24 months must 
give  a  negative  reaction  to  a  serological  test  carried  out  in  accordance  with 
Chapter II. 

E.  In-accordance with the procedure in Article 17, the Commission may propose that a 
Member State or region of a Member State may become officially  enzootic-bovine-
leukosis-free  if: 

(a)  at least  99,8% of the bovine herds  are officially  enzootic  bovine  leukosis  free 

herds within the meaning of A; 

or 

(b)  no case of enzootic bovine leukosis has been confirmed  in the Member State or 

region for the past three years and 

13 

in the case of a Member State, all animals aged over 24 months in at least  10% 
of  the  herds,  selected  randomly,  have  been  tested  with  negative  results  in 
accordance with Chapter II in the prevjpus 24 months or 

in the case of a region or a Member State, all animals aged over 24 months have 
undergone a test provided for  in Chapter II with negative results in accordance 
with Chapter II in the previous 24 months; 

or 

(c)  any  other  method  which demonstrates  to a confidence  rating  of  99% that  less 

than 0,2%) of herds were infected. 

, 

F.  A  Member  State  or  a  region  of  a  Member  State  shall  retain  officially 

enzootic-bovine-leukosis-free  status if: 

(i)  every  year  either  a  random  sample  with  a  confidence  rating  of  99%  has 
established that less than 0,2% of the herds were infected or not less than 20% of 
bovine  animals  over  two  years  of  age  have  been  tested  and  have  reacted 
negatively to a test carried out in accordance with Chapter II; 

or 

(ii)  where  no  case  of  enzootic  bovine  leukosis  has  been  recorded  in  the  Member 
State or region in a proportion of one herd out of 10 000 for at least three years, 
a  decision  may  be  taken  in  accordance  with  Article 17  to  cease  routine 
serological testing provided that: 

-  all cattle slaughtered within the territory of that Member  State or region are 
submitted to a post-mortem examination by an official  veterinarian who must 
issue notification of all tumours with a view to laboratory examination, and 

-  the Member State shall report the occurrence of all cases of enzootic bovine 
leukosis  in  the  region  affected  by  the  decision  to  the  Commission.  The 
Commission may, in accordance with the procedure laid down in Article 17, 
propose that the decision to cease routine serological testing be suspended or 
revoked, and 

-  any cattle which react positively to an immune-diffusion  test are slaughtered 
and the herd remains subject to restrictions until re-establishment of its status 
pursuant to Chapter D.2 of this Annex. 

G.  (i)  The officially  enzootic-bovine-leukosis-free  status of a Member State or region 
of  a  Member  State  shall  be  suspended,  in  accordance  with  the  procedure  in 
Article 17, if enzootic bovine  leukosis  is detected  and confirmed  in more than 
0,2% of holdings in the region or Member State. 

14 

(ii)  The  officially  enzootic-bovine-leukosis-free 
accordance with the procedure in Article  17, if: 

status  may  be  restored 

in 

(a)  in  addition to  the  measures  provided  for  in paragraphs D.l  and 2,  at  least 
20% of the other herds, selected  randomly,  in the region or Member  State 
have, within a  12-months period, undergone  one  of the tests referred  to  in 
Chapter II; 

(b)  the  results  of  this  testing  establish,  with  a  confidence  rating  of  99%, that 

less than 0,2% herds are infected* 

15 

BOVINE SPECIES/SWINE FOR SLAUGHTER/BREEDING/PRODUCTION1 

ANNEXF 

Species: 

Member State of origin: 

- 

Region of origin: 

Certificate No: 

SECTION A 

Name and address of consignor: 

Name and address of holding of origin: 

Dealer's registration number: 

Health data concerning bovine animals 

I  certify  that  the  animals  listed  below  are  from  a  herd  or  herds  which  is  officially 
tuberculosis, brucellosis and leukosis free and that3: 

the herd of origin is situated in a Member State or part of the territory of a Member 
State which is recognized as being: 

1. officially  tuberculosis free: 

yes/no 

Commission Decision ...A../...1 

2.  officially  brucellosis free: 

yes/no 

Commission Decision 

.J.J..} 

3.  officially  leukosis free: 

yes/no 

Commission Decision.../.../... 

the  Member  State  or  part  of  the  territory  of  a  Member  applies  a  system  of 
surveillance networks: 

Commission Decision.../.../... 

1  Delete if not applicable. 

2  Not applicable where animals are from several holdings. 

3  Does not apply in the case of a derogation granted to Spain for animals for slaughter. 

16 

the  animals  listed  below  have  been  tested  with  negative  results  during  the  30 days 
prior 
in  accordance  with  Article  6(2)  of 
to  departure  from 
Directive 64/432/EEC, as follows: 

the  holding 

Date of test 

Tuberculin test (animals of over six weeks): 

yes/not required: 

Serum agglutionation test for brucellosis (except 
castrated animals or those under 12 months of age): 

yes/not required: 

Test for leukosis (animals over 12 months of age): 

yes/not required: 

are animals for  slaughter 

are animals for  slaughter from herds which are not officially  tuberculosis, brucellosis 
and  leukosis  free,  originating  from  a  holding  in  Spain1  4;  the  animals listed  below 
have been tested  with negative  results during  the  30 days before  departure  from  the 
holding of origin, as follows: 

Date of test 

Tuberculin test: 

Serum agglutination test for brucellosis: 

Test for leukosis: 

SECTION B 

l 

l 

ï 

Identification  of the animal 

Total number of animals: 

Race: 

Type: 

Age: 

Official  identification: 

Date of departure: 

Section A and B  certification 

Official  stamp 

Signature of the official  veterinarian: 

of  the  holding  of  origin,  or  in  the  case  of  a  Member  State 
which has introduced  a surveillance network  system,  signature 
of the approved veterinarian of the holding of origin  : 

Name (in capitals): 

Date: 

4 

Subject to agreement from the country of destination. 

17 

SECTION C 

Approved assembly centre1 

Name of centre: 
Address: 
Registration number: 
Arrival date: 
Departure date: 

Signature/stamp of official  veterinarian 

SECTION D 

Destination of animals : 
Name and address of consignor: 

Name and address of destination holding: 

Name and address of transit centre : 

Means of transport : 

Approval number: ....r 

: 

After inspection as required by regulations, I certify that: 

1.  on 

(date)  the  animals  in  question  had  been 
inspected  during  the  24 hours  before  departure  and  had  shown  no  clinical  signs  of 
infectious or contagious disease; 

2.  all applicable provisions in Council Directive 64/432/EEC have been  fulfilled; 

3.  the movement proposed has been registered by the Animo system on the day of issue; 

4.  the above animal(s) meet(s) the additional guarantees for 

disease(s) for 

(species/type) intended for 

(Commission Decision .../.../EC). 

Official  stamp 

Signature of the official  veterinarian: 
Name (in capitals): 
Official  title: 
Address: 

This  certificate  remains  valid  for  10 days  following  the  date  of  the  health  inspection 
referred to in Section D. 

18 

ISSN 0254-1475 

COM(97) 404 final 

DOCUMENTS 

EN 

03  15  10 

Catalogue  number  :  CB-CO-97-407-EN-C 

ISBN  92-78-23557-1 

Office  for Official  Publications of the European Communities 

L-2985 Luxembourg