Proposal for a Council Directive amending Council Directive 88/407/EEC of 14 June 1988 laying down the animal health requirements applicable to intraCommunity trade in and imports of deep-frozen semen of domestic animals of the bovine species and extending it to cover fresh bovine semen
Date: 1992-11-12
Institutions: European Commission
Subjects: animal breeding, animal disease, cattle, health control, intra-EU trade, veterinary inspection

COMMISSION  OF  THE  EUROPEAN  COMVIUNITIES 

C0M(92) 462 final 

Brussels,  12 November  1992 

Report  from the Commission 

on 

the animal  health  rules to be applied  to bovine semen for 

intra-Community  trade and  imports from the third countries in 

accordance with Article 4 of Directive  88/407/EEC 

and 

proposa I 

for a 

Counc iI D i rect i ve 

amending Council  Directive 88/407/EEC of  14 June 1988 

laying down the animal  health 

requirements applicable  to  intraCommunity  trade  in and  imports 

of deep-frozen semen  of domestic  animals of  the bovine 

species and extending  it to cover  fresh bovine semen 

(presented by the Commission) 

-  A 

-

EXPLANATORY  MEMORANDUM 

Council  Directive 88/407/EEC  lays down the animal  health  requirements applicable 

to  intra-Community  trade  in and  imports of deep-frozen semen of domestic animals 

of  the bovine species. At  the time of adoption, the situation  in Member  States 

with respect  to the status of  infectious bovine rhinotracheitis/infectious 

pustular  vulvovaginitis (IBR/IPV) in semen collection centres varied 

considerably. Article 4 therefore required  the Commission  to report on the 

situation, with appropriate proposals. 

The general  IBR/IPV situation  in Member  States has not changed significantly 

: 

since the Directive was adopted. There  is still  a need  to allow collection of 

semen from bulls which are positive  to a blood  test  for  this disease, because of 

the  long term nature of breeding programmes  (typically  10 years).  It  is therefore 

proposed  to continue the use of bulls which were positive before vaccination 

until  the 10-year  cycle comes to an end  (1998), and  to allow vaccination to 

continue until  such  time as Member  States make progress  in eradication  in the 

national  herd. 

Additionally, proposals are made to 

- clarify  the situation with respect  to the brucellosis, enzootic bovine  leucosis 

(EBL) and tuberculosis status of  the bull on entry  to a collection centre, 

- discontinue virus  isolation  testing  for  foot and mouth disease  (FMD) for bulls 

vaccinated more than 12 months prior  to collection, and  to reduce the number of 

semen straws to be tested  from  10 to 5%, 

- discontinue  the treatment of bulls with streptomycin against  leptospirosis, 

-  remove the requirement  for a bull  to be on a collection centre  for  30 days 

before collection  for  trade purposes, 

- extend  the Directive to cover  fresh semen and 

- allow future amendments to the annexes by the Commission under  the Regulatory 

procedure. 

-  A (r^o 

Report  from  the Commission 

on 

the  animal  health  rules  to be applied  to bovine  semen for 

intra-Community  trade  and  imports  from  the third  countries  in 

accordance  with  Article  4 of Directive  88/407/EEC 

Introduct ion 

Council  Directive  88/407/EEC  laying  down  the animal  health  rules  applicable to 

intra-community  trade  in and  imports  from  third  countries  of deep-frozen  semen of 

domestic  animals  of the bovine  species was adopted  by Council  on 14 June 

1 9 8 8 d ).  It w as subsequently  amended  in particular  by Council  Directive 

9 0 / 1 2 0 / E E C *2) on 5 March  1990, with  respect  to rules  relating  to semen  derived 

from  bulls  which  were  serological I y  positive  for  I BR,  either  before  entry or 

following  vaccination  on the centre.  Special  rules  were  introduced  in Article  4 

to  allow  Member  States  to continue  trade  in semen  from  such  b u l l s,  for a 

transitional  period  until  31 December  1992.  These  rules  were  required  to be 

reviewed  by 1 January 1992. 

The  purpose  of  this  report  is to made  such  reviews, and also  to  identify  other 

problems  found  during  the implementation of the Directives,  in support of 

proposals  for suitable  amendments. 

I BR 

IBR  is a disease  of cattle  caused  by a Herpes  virus.  It can manifest  itself  in 

either  a  respiratory  form  or a urogenital  form.  It  is the respiratory  form  which 

is most  commonly  recognised  in the Community.  The disease may appear  in the acute 

or  sub acute  form, but no serological  differences  have  been  identified  between 

the  strains.  In the urogenital  form,  it causes  balanoposthitis  in the male and 

vulvovaginitis  in the female.  It may be the cause  of  infertility,  particularly  in 

the  female.  Vaccines may be used  to control  its effects.  However,  vaccines 

probably  do not prevent  infection  by  field  virus. 

(1) OJ No L 194 of  22.07.1988, p. 10 
(2) OJ No L  71 of  17.03.1990, p. 37 

-  2  -

The  presence  of  virus  in  the  semen  is  a  potential  means  of  spread.  This  is 

complicated  by  the  problem  of  latency.  This  means  that,  after  a  clinical  or 

subclinical  infection,  the  virus  may  remain  latent  for  the  life  of  the  animal.  It 

may  also  be  reactivated  and  shed  at  irregular  intervals,  particularly  if  the 

animal  is stressed  or  has  corticosteroids  administered  to  it.  Infected  bulls  must 

therefore  be  regarded  as  potential  lifelong  shedders  of  virus. 

Few  countries  have  attempted  to  eradicate  the  disease  in  their  national  herd. 

Denmark  has  a  national  programme,  and  Ireland  has  had  rules  in  the  past  designed 

to  prevent  the  introduction  of  virulent  forms  which,  it  was  claimed  were  absent 

from  the  island.  In  the  AI  industry,  as  a  general  rule,  attempts  are  made  to 

ensure  freedom  of  the  bulls  from  IBR,  in  view  of  its  importance  as  a  disease  of 

breeding.  This  is done  either  by  exclusion  of  any  seropositive  animal  from  the 

centres,  or  by  a  policy  of  vaccination  after  initial  testing  (with  negative 

results).  Some  countries  maintain  separate  IBR  positive  and  negative  studs.  In 

positive  centres,  semen  from  a  clinically  affected  animal  would  not  be  used. 

Furthermore,  there  are  still  some  centres  which  contain  bulls  which  were  not 

tested  prior  to  entry,  and  which  were  vaccinated,  before  the  Directive  was 

adopted.  Their  true  status  is,  therefore,  unknown.  Trade  in  semen  from  the  latter 

category  of  bulls  is permitted  until  31/12/92,  subject  to  a  negative  virus 

isolation  test  being  carried  out  on  the  semen  before  export.  Trade  in  semen  from 

bulls  which  were  seronegative  before  vaccination  is also  permitted,  without  virus 

isolation.  In both  cases,  Member  States  in which  all  centres  are  seronegative  may 

refuse  semen  from  centres  which  do  not  have  that  status. 

A major  problem  with  semen  is  its  long  storage  time  after  collection.  Because  of 

this,  and  the  length  of  cattle  breeding  programmes  (typically  5  years  to  prove  a 

dairy  bull  and  at  least  5  years  full  use  after  testing),  there  will  be  a  great 

deal  of  semen  in  stores  by  the  end  of  the  transitional  period.  A  limited  survey 

has  been  carried  out  in  some  Member  States.  This  survey  shows  that  an  abrupt 

cessation  of  trade  in semen  from  positive  bulls  at  the  end  of  1992  wiI  be  very 

costly  and  will  rob  the  industry  of  valuable  genetic  material.  (Table 1 ). 

-  3 

Similarly,  there  are  bulls  of  great  genetic  value  in centres  in  some  third 

countries.  It  is  important  to  have  access  to  this  genetic  material  for  a  further 

limited  period.  Many  breeding  programmes  started  at  the  time  of  adoption  of  the 

Directive,  i.e.  1988,  and  the  bulls  in  these  programmes  will  be  used  at  least 

until  1998. 

It  is clear  that  Council  Directive  88/407/EEC  gave  impetus  to  the  objective  of 

finally  eradicating  this  disease  from  AI  centres. While  this  should  continue  to 

be  the  long-term  aim,  the  practicality  of  maintaining  a  bull  centre  free  from  IBR 

without  vaccination  in a  country  where  the  cattle  in  the  national  population  are 

infected  must  be  questioned.  The  airborne  route  of  infection  is not  normally 

considered  to be  a major  source  of  infection,  especially  over  long  distances. 

However,  this  route  cannot  be  excluded.  Therefore,  it  is essential  to  consider 

the  possible  action  to  be  taken  if  a  centre  becomes  infected. 

There  are  three  options: 

-  slaughter  of  all  stock, 

-  vaccination  of  all  stock, 

-  testing  with  removal  of  infected  animals  and  vaccination  of  the  remainder. 

The  first  option  is unacceptable,  in view  of  the  financial  and  genetic  value  of 

the  bulls.  The  second  option  would  leave  infected  bulls  on  the  centre;  this  would 

present  a  hazard  to  incoming  animals,  and  is not  consistent  with  the  long-term 

aim.  The  third  option  is best,  therefore. 

The  draft  proposal  attached  to  this  report  proposes  to maintain  the  trade  in 

semen  from  bulls  of  unknown  status  until  the  end  of  1998,  and  to  allow 

vaccination  of  seronegative  bulls  on  the  centres  where  desired  by  the  Member 

State  concerned.  The  virus  isolation  test  would  continue  to  be  required  for  all 

semen  from  seropositive  bulls  which  had  not  been  found  to  be  seronegative  prior 

to  vaccination  on  the  centre.  Seropositive  bulls  may  not  enter  a  centre  at  all. 

The  protocols  for  the  serological  and  virological  tests  and  the  number  of  straws 

to  be  tested  will  be  established  by  the  Commission. 

Foot  and  Mouth  Disease  (FMD) 

-  4  -

Article  4 of  the  Directive  also makes  provisions  for  virus  isolation  or  animal 

innoculation  tests  on  semen  from  bulls  vaccinated  against  FMD, when  going  to a 

non-vaccinating  country.  Council  Directive  90/423/EEC^3) banned  the  use  of  FMD 

vaccine  as  and  from  1/1/92,  and,  in practice,  all  Member  States  had  stopped  by 

August  1991. This  requirement  should  therefore  be  reviewed.  The  opinion  of  the 

Scientific  Veterinary  Committee  is that  semen  produced  from  bulls  vaccinated  more 

than  12 months  before  semen  collection  presents  only  a negligible  risk,  assuming 

that  the  centre  was  free  from  FMD  at  the  time  of  collection.  Therefore  it  is 

proposed  that  the  testing  should  apply  to  trade  in semen  between  all  Member 

States,  but  only  on  semen  collected  within  12 months  of  vaccination. 

Additionally,  the  Scientific  Veterinary  Committee  has  recommended  that  the  number 

of  straws  to be  tested  can  be  reduced  to  5%  from  10%. 

Furthermore,  under  a non-vaccination  policy,  there  is no  further  need  to  keep 

fresh  semen  out  of  the  scope  of  the  Directive. Virus  isolation  tests  would  limit 

the  practicality  of  trade  in fresh  semen,  but  are  not  needed  for  all  collections 

(see  preceding  paragraph).  This  applies  equally  to  IBR. 

Quarantine  of  bulls  and  semen 

Annex  C  requires 

-  i) 

that  the  bulls  are  kept  on  the  approved  centre  for  30 days  prior  to 

collect ion,  and 

-  ii)  that  the  semen  is stored  30 days  prior  to  dispatch. 

This  double  quarantine  is considered  to be  unnecessary,  and  one  element  could  be 

deleted.  The  quarantine  on  semen  itself  gives  the  best  guarantee  that  the  health 

status  at  the  time  of  collection  was  satisfactory.  Furthermore,  the  bulls  are 

subjected  to  intensive  testing  before  entry  into  the  centre. 

(3) OJ  No  L  224 of  18.08.1990, p.  13 

-  5 -

It  is therefore  proposed  that  the  requirement  for  the  bull  to  be  in  the  centre 

for  30 days  prior  to  collection  can  be  revoked.  To  allow  trade  in  fresh  semen,  it 

is also  necessary  to  remove  the  quarantine  for  this  category;  this  can  be 

justified  on  the  basis of  the  very  low  volume  of  trade  in  fresh  compared  with 

frozen  semen. 

Other  problems 

Other  difficulties  have  been  highlighted  by  Member  States. Appropriate  amendments 

have  therefore  been  proposed. 

a)  The  double  requirement  to  treat  bulls  and  semen  with  antibiotics  against 

Leptospirosis  can  be  replaced  by  single  treatment  of  the  semen  with  suitable 

ant ibiot ics. 

b)  Currently,  a bull  must  either  come  from  a  herd  which  is free  from  enzootic 

bovine  leucosis or  its dam  must  be  tested  within  30 days  of movement  of  the 

bull  to  the  centre. This  is  illogical, as  it  is the  status of  the  dam  at  the 

time of  weaning  which  is most  relevant.  Therefore  it  is proposed  that  this 

test  on  the  dam  should  be  done  after  removal  of  the  bull  from  its dam.  Where 

the  bull  is born  as  a  result  of  embryo  transfer,  the  recipient  female  is 

regarded  as  the  dam. 

c)  The  current  requirement  in respect  of  brucellosis  status  is that  the  bull 

must  come  from  an officially  free  herd  and must  not  have  been  in any  other 

herd  of  lower  status. The  latter  requirement  is automatic,  given  the  rules 

for  movement  into officially  free  herds,.and  has  lead  to confusion  of 

interpretation.  It  is therefore  proposed  that  reference  is made  directly  to 

the  definition  of  an officially  free  herd  in Directive  64/432/EEC*4>. 

(4) 0J  No L  121 of  29.0».1964,  p.  2012/64 

- 6 -

TABLE 1 

IBR - Positive  and negative  bulls on centre  in 
Belgium  and the Netherlands 

Predicted  situation  on 1 January  1993 

Year  of  birth 

I BR  Pos 

I BR  Neg 

Total 

THE NETHERLANDS 

1981 
1982 
1983 
1984 
1985 
1986 
1987 
1988 
1989 
1990 
1991 

1 
3 
2 
7 
5 
5 
10 
61 
95 
-
-

0 
0 
0 
1 
5 
6 
22 
340 
440 
450 
450 

1 
3 
2 
8 
10 
11 
32 
401 
535 
450 
450 

TOTAL 

179 

1714 

1903 

BELGIUM 

1987 
1988 
1989 
1990 
1991 

TOTAL 

10 
89 
104 
96 
-

299 

1 
27 
28 
37 
128 

221 

11 
116 
132 
133 
128 

510 

- 3-

proposa I 

for a 

CounciI Directive 

amending CounciI Directive 88/407/EEC of  14 June 1988 

laying down the animal  health 

requirements applicable to  intraCommunity  trade  in and  imports 

of deep-frozen semen  of domestic  animals of the bovine 

species and extending  it to cover  fresh bovine semen 

THE COUNCIL OF THE EUROPEAN  COMMUNITIES 

Having  regard  to the Treaty establishing the European Economic Community, and in 

particular Article 43 thereof; 

Having regard to the proposal  from the Commission^1), 

Having regard  to the opinion of  the European Par Iiament^2), 

Having  regard to the opinion of  the Economic and Social  Committee*3^, 

Whereas Council  Directive 88/407/EEC^4^, as  last amended by 

Directive 90/425/EEC^5^  rays down the animal  health  requirements applicable to 

intra-Community trade  in and  imports of deep frozen semen of domestic animals of 

the bov i ne spec i es ; 

Whereas Article 4 of Directive 88/407/EEC defined provisional  measures  for trade 

in semen from bulIs which are seropositive for  Infectious Bovine Rhinotracheitis 

(IBR);  whereas these requirements should be reviewed, on  the basis of a report 

from the Commission;  whereas this report  indicates that  it  is necessary  to 

phase out bulls which were seropositive or of unknown status  prior to 

vaccination on the centre by 1998, and  to maintain  the possibility  to vaccinate 

on a centre  in the future;  whereas  it  is necessary  to amend Article 4  in this 

respect ; 

(1) OJ No C 
(2) OJ No C 
(3) OJ No C 
(4) OJ No L  194, 22.07.1988, p. 10 
(5) OJ No L 224, 18.08.1990, p. 29 

-2  -

Whereas routine foot and mouth disease vaccination has been discontinued  in the 

Community  as from August  1991;  whereas therefore  it  is necessary  to amend the 

provisions of  the Directive to take account of  this change  in policy;  whereas 

this change  in policy also permits trade  in fresh bovine semen to take place 

under harmonised rules; 

Whereas  it  is opportune  to make further  amendments to the Directive  to clarify 

certain  issues and to take account of changes  in technical  knowledge, 

particularly  in respect of  treatment of bulls against  leptospirosis, and  to align 

the rules with respect  to brucellosis, tuberculosis and  leucosis with  those laid 

down  in Council Directive 64/432/EEC^6^; 

Whereas  it  is appropriate to provide for amendments to the Annexes under a 

procedure establishing close coopérât ion between Member  States and the Commission 

within the Standing Veterinary Committee, 

HAS ADOPTED THIS DIRECTIVE: 

Article 1 

Directive 88/407/EEC  is hereby amended as follows : 

1.  In the title, the words "deep frozen" are deleted. 

2.  In Article  1, the words "deep frozen" are deleted. 

3.  In Article 3, the existing  text  is prefixed by the number  1, and the 

following paragraph  2  is added: 

"2. Member  States which  implement  an alternative control  system providing 

guarantees equivalent  to those  laid down  in this Directive as regards 

movements within their  territory of bovine semen,  in particular  with regard 

to the certificate, may grant one another  derogations from  the provisions of 

paragraph  1(d) and Article 6, on a reciprocal basis. 

They shall notify  the Commission thereof." 

(6) OJ No L 121, 29.09.1964, p. 2012/64 

- 3-

4.  Article  4 paragraph  1  is  replaced  by  the  following: 

"1.  Without  prejudice  to  paragraph  2, Member  States  shall  authorize  the 

admission  of  semen  from  bulls  giving  a negative  reaction  to  the  serum 

neutralization  test  or  the  Elisa  test  for  infectious  bovine  rhino-

tracheit is/infectious  pustular  vulvo-vaginitis  or  showing  a  positive  result 

after  vaccination  in accordance  with  this  Directive. 

Member  States  may,  until  31  December  1998,  authorize  the  admission  of  semen 

of  bulls  giving  a positive  reaction  to  the  serum  neutralization  test  or  the 

Elisa  test  for  infectious  bovine  rhino-tracheitis/infectious  pustular  vulvo 

vaginitis  and  not  having  been  vaccinated  in accordance  with  this  Directive. 

In  that  case,  each  consignment  must  pass  an  examination  by  inoculation  into a 

live  animal  and/or  a  virus  isolation  test. 

This  requirement  shall  not  apply  in  respect  of  the  semen  of  animals  which, 

prior  to  their  first  vaccination  at  the  insemination  centre,  reacted 

negatively  to  the  tests  referred  to  in  the  first  paragraph. 

These  examinations  can,  by  bilateral  agreement,  be  carried  out  either  in  the 

country  of  collection  or  in  the  country  of  destination. 

Protocols  for  tests  to be  used  in accordance  with  this  Article,  and  the' 

number  of  straws  to  be  tested  for  each  collection,  shall  be  laid  down  in 

accordance  with  the  procedure  in Articie-18." 

5.  Article  4  paragraph  3  is replaced  by  the  following: 

"3.  Member  States  may  not  oppose  the  admission  of  semen  produced  from  bulls 

vaccinated  against  foot  and  mouth  disease.  However,  where  the  semen  was 

obtained  from  a  bull  which  had  been  vaccinated  against  foot  and  mouth  disease 

during  the  12 month  period  prior  to  collection,  5% of  each  collection  (with  a 

minimum  of  five  straws)  intended  for  sending  to  another  Member  State  shall  be 

subjected  to  a  virus  isolation  test  for  foot  and  mouth  disease,  with  negative 

results." 

6.  Article  12  is  replaced  by  the  following: 

"Article  12 

The  rules  laid  down  in Council  Directive  90/675/EEC  of  10 December  1990 

laying  down  the  principles  governing  the organization  of  veterinary  checks  on 

products  entering  the  Community  from  third  countries^7)  shall  apply  in 

particular  to  the organization  and  follow-up  of  checks  to be  carried  out  by 

the Member  States,  and  the  safeguard  measures  to  be  applied." 

7.  Articles  13  and  14 are  deleted. 

8.  Article  17  is replaced  by  the  following  : 

"Article  17 

Amendments  to  the  annexes  to  this  Directive,  in particular  to  adapt  them  to 

advances  in  technology,  shall  be  decided  in accordance  with  the  procedure 

laid  down  in Article  18." 

9.  In Article  18 at  the  end  of  the  4th  paragraph,  the  words  "save  where  the 

Council  has  decided  against  the  said  measure  by  a  simple  majority"  are 

deleted. 

10.  In Article  19 at  the  end  of  the  4th  paragraph,  the  words  "save  where  the 

Council  has  decided  against  the  said  measures  by  a  simple  majority"  are 

deleted. 

11.  In Annex  A,  chapter  ll,  the  following  subparagraph  is added  at  the  end  : 

"The  competent  authority  may  authorize  the  storage  in  the  approved  semen 

storage  premises  of  embryos  which  meet  the  requirements  of  Directive 

89/556/EEC  of  25  September  1989 on  animal  health  conditions  governing  intra-

Community  trade  in and  imports  from  third  countries  of  embryos  of  domestic 

animals  of  the  bovine  species*8^." 

(7) 0J  No  L  373 of  31.12.1990,  p.  1 
(8) 0J  No  L 3r2 of  19.10.1989,  p.  1 

- > M-

12.  In Annex  B,  Chapter  I, paragraph  1,  (b)  is  replaced  by  : 

"(b) prior  to  their  stay  in  isolation  accommodation  described  in  (a), have 

belonged  to  a  herd  which  is officially  tuberculosis  free  and  officially 

brucellosis  free,  as  defined  in Annex  A.11  of  Directive  64/432/EEC." 

13.  In Annex  B,  Chapter  I the  first  sub  paragraph  of  paragraph  1(c)  is  replaced 

by: 

"have  come  from  an  enzootic  bovine  leucosis  free  herd  as  defined  in 

Directive  64/432/EEC,  or  have  been  produced  by  dams  which  have  been  subjected 

to  an  Agar  Gel  Immunodiffusion  test,  carried  out  in accordance  with  Annex  G 

of  Directive  64/432/EEC,  after  removal  of  the  animals  from  their  dam.  In  the 

case  of  animals  derived  by  embryo  transfer,  "dam"  means  the  recipient  of  the 

embr yo." 

14.  In Annex  B,  Chapter  I, paragraph  1(e), in  the  last  sentence  the  words  "and 

have  treatment  against  leptospirosis  comprising  two  injections  of 

streptomycin  at  an  interval  of  14 days  (25mg  per  kilogram  of  live  body 

weight)."  are  deleted. 

15.  In Annex  B,  Chapter  II, paragraph  1,  (iii)  is replaced  by: 

"(iii) a serological  test  for  enzootic  bovine  leucosis,  carried  out  in 

accordance  with  Annex  C  to  Directive  64/432/EEC,  with  a  negative  result." 

16.  In Annex  B,  Chapter  II, paragraph  1(iv)  the  words  "until  31  December  1992" 

are  deleted. 

17.  In Annex  B,  Chapter  II,  paragraph  3  the  words  "until  31  December  1992"  and, 

at  the  end,  the  words  "under  Article  4(1)  second,  third  and  fifth 

subparagraphs"  are  deleted. 

18.  In Annex  C  paragraph  1,  (b)  is  replaced  by  the  following: 

"b)  (i) were  not  vaccinated  against  foot  and  mouth  disease  during  the 

12 months  prior  to  collection 

or 

(ii) were  vaccinated  against  foot  and  mouth  disease  during  the  12  months 

prior  to  collection,  in which  case  5%  (with  a minimum  of  five  straws)  of  the 

collection  shall  be  submitted  to  a  virus  isolation/animal  inoculation  test 

for  foot  and  mouth  disease  with  negative  results," 

19.  In Annex  C,  sub-paragraph  1(d)  is deleted  and  the  remaining  sub-paragraphs 

are  accordingly  renumbered. 

20.  In Annex  C  paragraph  3,  (i)  is  replaced  by  the  following: 

"be  stored  in approved  conditions  for  a minimum  period  of  30  days  prior  to 

dispatch.  This  requirement  shall  not  apply  to  fresh  semen." 

21.  In Annex  D  IV,  paragraph  4  (iii),  the  word  "consignment"  is  replaced  by  the 

word  "collect ion". 

22.  In Annex  D  IV,  paragraph  5  is  replaced  by: 

"5.  The  semen  described  above  was  collected  from  bulls  : 

(i) which  have  not  been  vaccinated  against  foot  and  mouth  disease  within 

12 months  prior  to  collection(1); 

or 

(ii) which  have  been  vaccinated  against  foot  and  mouth  disease  within 

12 months  prior  to  collection,  in which  case  the  semen  comes  from  a 

collection  in which  5%  of  each  collection  intended  for  trade  (with  a 

minimum  of  5  straws)  has  been  subjected,  with  negative  results,  to a 

virus  isolation  test  for  foot  and  mouth  disease  in 

laboratory(2)."  . 

23.  In Annex  D  IV  the  following  is  added: 

"6.  the  semen  was  stored  in approved  conditions  for  a minimum  period  of 

30  days  prior  to  dispatch(3)." 

-  A 2,  -

24.  In Annex  D,  in footnote  (2), the words  "the  second  subparagraph  of 

Article  4(1)" are  replaced  by  "Article  4". 

25.  In Annex  D,  the  following  footnote  (3)  is added  : 

"(3) may  be  deleted  for  fresh  semen." 

Article  2 

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

provisions  necessary  to comply  with  this  Directive  by  1 April  1993. They 

shall  inform  the Commission  thereof. 

2. When  Member  States  adopt  the measures  referred  to  in paragraph  1,  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  reference  shall  be  laid  down  by  the Member  States. 

This  Directive  is addressed  to  the Member  States. 

Art icle 3 

Done  at 

For  the Council 

-4  11-

ISSN 0254-1475 

COM(92) 462 final 

DOCUMENTS 

EN 

03 

Catalogue number : CB-CO-92-486-EN-C 

ISBN 92-77-49019-5 

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