Proposal for a Council Directive simplifying procedures of listing and publishing information in the veterinary and zootechnical fields and amending Directives 64/432/EEC, 77/504/EEC, 88/407/EEC, 88/661/EEC, 89/361/EEC, 89/556/EEC, 90/427/EEC, 90/428/EEC, 90/429/EEC, 90/539/EEC, 91/68/EEC, 92/35/EEC, 92/65/EEC, 92/66/EEC, 92/119/EEC, 94/28/EC, 2000/75/EC, Decision 2000/258/EC and Directives 2001/89/EC, 2002/60/EC, and 2005/94/EC
Date: 2008-02-29
Institutions: European Commission
Subjects: animal breeding, animal product, dissemination of information, health control, live animal, livestock farming, research body, trading operation, veterinary inspection, veterinary legislation

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 29.2.2008 
COM(2008) 120 final 

2008/0046 (CNS) 

Proposal for a 

COUNCIL DIRECTIVE 

simplifying procedures of listing and publishing information in the veterinary and 
zootechnical fields and amending Directives 64/432/EEC, 77/504/EEC, 88/407/EEC, 
88/661/EEC, 89/361/EEC, 89/556/EEC, 90/427/EEC, 90/428/EEC, 90/429/EEC, 
90/539/EEC, 91/68/EEC, 92/35/EEC, 92/65/EEC, 92/66/EEC, 92/119/EEC, 94/28/EC, 
2000/75/EC, Decision 2000/258/EC and Directives 2001/89/EC, 2002/60/EC, and 
2005/94/EC 

(presented by the Commission) 

EN 

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EXPLANATORY MEMORANDUM 

The general objective of the Commission’s proposal is to harmonise and simplify the current 
procedures for updating and publishing information in the veterinary and zootechnical fields, 
such as lists of approved animal health establishments and breeding organisations in Member 
States  and  Third  Countries  and  lists  of  certain  national  reference  laboratories  and  other 
approved laboratories. 

The  Commission’s  proposal  aims  at  amending  20  Directives  and  one  Decision  ,  ensuring  a 
simplified  approach,  which  will  lead  to  benefits  in  terms  of  reduced  workload  and 
administrative  burdens  to  the  competent  authorities  in  the  Member  States,  the  farming 
industry and trade operators and the Commission. 

▪▪▪▪▪▪▪▪▪ 

• 

Animal  health  establishments  approved  for  intra-Community  trade  in  live  animals 
and their products and information to be provided in the zootechnical field 

Community  legislation  in  the  veterinary  field  lays  down  that  assembly  centres  for 
bovine,  porcine,  caprine  and  ovine  animals,  dealers  of  those  animals,  poultry 
establishments,  semen  collection  or  storage  centres  and  embryo  collection  or 
production teams and certain bodies, institutes and centres are to comply with certain 
conditions  and  must be officially  approved by Member States  for intra-Community 
trade  of  certain  live  animals  and  their  products,  and  in  particular  animal  genetic 
materials such as semen, ova and embryos. 

Current  Community  legislation  provides  for  different  procedures  with  regard  to 
registration,  listing,  update,  transmission  and  publication  of  these  animal  health 
establishments. Differences in the procedure make the listing and the update however 
complicated and the practical use of these lists for the competent control services and 
the concerned operators very difficult. 

Therefore  the  procedures  should  be  harmonised  and  provide  for  more  systematic, 
coherent  and  uniform  rules  with  regard  to  the  five  key  elements  of  the  procedure, 
namely registration, listing, update, transmission and publication of the lists. 

In addition, since it is for the Member States to control the conditions that must be 
fulfilled  by  the  different  animal  health  establishments  in  order  to  be  listed,  the 
responsibility for the drawing up of the lists should lay with the Member States, and 
not the Commission.  

Member  States  should  therefore  draw-up  and  keep  up-to-date  lists  of  the  animal 
health establishments concerned and make them available to the other Member States 
and  to  the  public.  In  order  to  harmonise  the  model  of  those  lists  and  the  way  to 
achieve a simple access to up-to-date lists for the Community, common criteria need 
to be introduced under the comitology procedure. 

EN 

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In  the  interests  of  clarity  and  consistency  of  Community  rules,  this  new  procedure 
should  also  apply  in  the  zootechnical  field,  in  particular  to  breeding  associations 
approved  for  maintaining  or  establishing  herd  books,  flock  books  or  stud  books  in 
Member  States  and  to  information  to  be  provided  by  Member  States  regarding 
equine  competitions  in  accordance  with  Council  Directive  90/428/EEC  of  26  June 
1990 on trade in equidae intended for competitions and laying down the conditions 
for participation therein. 

• 

Animal  health  establishments  approved  in  third  countries  for  imports  of  animal 
products  into  the  Community  and  authorities  approved  in  third  countries  for  the 
purpose of keeping a herd book, a flock book or a studbook 

Similarly to the rules applied to intra Community trade, imports of semen, ova and 
embryos  are  regulated  in  such  a  way  that  the  establishments  of  origin  in  third 
countries  are  to  fulfil  certain  conditions  in  order  to  minimise  animal  health  risks. 
Accordingly,  imports  into  Community  of  such  genetic  materials  should  only  be 
authorised  from  semen  collection  or  storage  centres  and  embryo  collection  or 
production teams officially approved for export to the Community by the competent 
authorities  of  the  third  country  concerned  in  accordance  with  Community 
requirements  and  following  Community  veterinary  inspections,  where  appropriate. 
Depending on the type of genetic materials and on the species concerned, the current 
procedures for listing animal health establishments and updating the relevant lists are 
different,  ranging  from  decisions  adopted  under  a  comitology  procedure  in 
accordance  with  Council  Decision  1999/468/EC  of  28  June  1999  laying  down  the 
procedures for the exercise of implementing powers conferred on the Commission1 
to a simple consultation with Member States.  

The  co-existence  of  different  procedures  can  lead  to  confusion  and  uncertainty 
amongst  administrative  officials  in  third  countries,  the  farming  industry  and  trade 
operators. Since it is for the third countries to check on the conditions that must be 
fulfilled  by  the  different  animal  health  establishments  in  order  to  be  listed  as 
approved for export to the Community in accordance with Community requirements, 
the current legal framework for the authorisation of those  establishments should  be 
harmonised and simplified, so that the responsibility for drawing up and updating the 
lists  lies  with the third countries and not the Commission. It is  important to ensure 
that the level of animal health guarantees given by the third country concerned is not 
affected.  The  simplification  measures  are  without  prejudice  to  the  right  of  the 
Commission to take safeguard measures if necessary. 

The different existing procedures should therefore be replaced by a procedure under 
which the competent authorities of the third countries draw up, keep up-to-date the 
lists and communicate them to the Commission. The Commission should inform the 
Member  States  about  these  lists  and  makes  them  available  to  the  public  for 
information purposes. In the case of concerns with regard to the lists communicated 
by the third countries, adoption of safeguard measures is to be taken in accordance 
with Council Directive 97/78/EC. 

1 

OJ L 184, 17.7.1999, p. 23. Decision as last amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, 
p. 11). 

EN 

3 

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For reasons of clarity and consistency, that procedure should also apply to authorities 
in third countries approved for the purpose of keeping a herd book, a flock book or a 
studbook in accordance with Community zootechnical legislation. 

• 

Laboratories 

In  the  veterinary  field,  the  Commission  has  the  responsibility  for  setting  up  and 
updating  the  lists  of  approved  national  reference  laboratories  and  other  approved 
laboratories on the basis of information provided for by the Member States. 

In  accordance  with  existing  Community  legislation,  amendments  to  those  lists  are 
made,  following  a  request  from  a  Member  State  and  a  decision  adopted  under  a 
comitology  procedure  in  accordance  with  Decision  1999/468/EC  or  by  the  Council 
on a proposal from the Commission. 

However,  amendments  to  such  lists  are  often  of  purely  formal  nature,  such  as 
changes in the contact details of the laboratories in question. 

The  current  practice  has  been  to  make  only  periodic  updates  of  the  lists  of  those 
laboratories  to  reduce  the  number  of  Commission  decisions  to  be  taken.  However, 
this practice does not guarantee a rapid update of those lists. This could compromise 
the  legal  status  of  national  reference  laboratories  and  other  approved  laboratories. 
Since the Member States designate the national reference laboratories and provide all 
the  necessary  details  and  updates,  the  responsibility  for  the  drawing  up  of  the  lists 
should lay with the Member States and not the Commission. The same should apply 
to other approved laboratories in the Member States. 

Member  States  shall  therefore  draw-up  and  keep  up-to-date  the  lists  of  national 
reference  laboratories  and  other  approved  laboratories  concerned  and  make  them 
available to the other Member States and the public. In order to harmonise the model 
of  those  lists  and  the  way  to  achieve  a  simple  access  to  up-to-date  lists  for  the 
Community, common criteria need to be introduced under the comitology procedure.  

However,  where  the  lists  concern  approved  laboratories  situated  in  third  countries, 
the Commission should continue to be responsible for drawing up and publishing the 
lists of such laboratories. 

The purpose of this proposal is: 

– 

– 

– 

to harmonise and simplify the current procedures for updating and publishing lists of 
certain approved animal health establishments and breeding organisations in Member 
States  and  information  to  be  provided  by  Member  States  regarding  equine 
competition; 

to harmonise and simplify the current procedures for updating and publishing lists of 
certain  approved  animal  health  establishments  and  authorities  approved  for  the 
purpose of keeping a herd book, a flock book or a studbook in third countries; 

to  simplify  the  current  procedures  for  updating  and  publishing  lists  of  certain 
national reference laboratories and other approved laboratories. 

EN 

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Directives  64/432/EEC,  77/504/EEC,  88/407/EEC,  88/661/EEC,  89/361/EEC,  89/556/EEC, 
90/427/EEC,  90/428/EEC,  90/429/EEC,  90/539/EEC,  91/68/EEC,  92/35/EEC,  92/65/EEC, 
92/66/EEC, 92/119/EEC, 94/28/EC, 2000/75/EC, 2001/89/EC, 2002/60/EC, 2005/94/EC and 
Decision 2000/258/EC should be amended accordingly.  

EN 

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2008/0046 (CNS) 

Proposal for a 

COUNCIL DIRECTIVE 

simplifying procedures of listing and publishing information in the veterinary and 
zootechnical fields and amending Directives 64/432/EEC, 77/504/EEC, 88/407/EEC, 
88/661/EEC, 89/361/EEC, 89/556/EEC, 90/427/EEC, 90/428/EEC, 90/429/EEC, 
90/539/EEC, 91/68/EEC, 92/35/EEC, 92/65/EEC, 92/66/EEC, 92/119/EEC, 94/28/EC, 
2000/75/EC, Decision 2000/258/EC and Directives 2001/89/EC, 2002/60/EC, and 
2005/94/EC 

(Text with EEA relevance) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article 37 thereof, 

Having  regard  to  Council  Directive  92/65/EEC  of  13  July  1992  laying  down  animal  health 
requirements governing trade in and imports into the Community of animals, semen, ova and 
embryos  not  subject  to  animal  health  requirements  laid  down  in  specific  Community  rules 
referred to Annex A(I) to Directive 90/425/EEC2, and in particular Article 10(6) thereof, 

Having regard to the proposal from the Commission3, 

Having regard to the opinion of the European Parliament4, 

Having regard to the opinion of the European Economic and Social Committee5 

Whereas: 

(1) 

Community  legislation  in  the  veterinary  field  provides  that  assembly  centres  for 
bovine,  porcine,  caprine  and  ovine  animals,  dealers  of  those  animals,  poultry 
establishments,  semen  collection  or  storage  centres  and  embryo  collection  or 
production 
institutes  and  centres  ('animal  health 
establishments') are to comply with certain conditions and must be officially approved 
by  Member  States  for  intra-Community  trade  in  certain  live  animals  and  their 
products, and in particular animal genetic materials, such as semen, ova and embryos.  

teams  and  certain  bodies, 

(2) 

Current  Community  legislation  provides  for  different  procedures  with  regard  to  the 
registration,  listing,  updating,  transmission  and  publication  of  those  animal  health 

2 

3 
4 
5 

OJ  L  268,  14.9.1992,  p.  54.  Directive  as  last  amended  by  Commission  Decision  2007/265/EC  (OJ  L 
114, 1.5.2007, p. 17). 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 

EN 

6 

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establishments.  However,  differences  in  the  procedures  make  the  listing  and  the 
updating  complicated  and  the  practical  use  of  those  lists  for  the  competent  control 
services and the concerned operators very difficult. 

(3) 

(4) 

Therefore  those  procedures  should  be  harmonised  and  provide  for  more  systematic, 
coherent  and  uniform  rules  with  regard  to  the  five  key  elements  of  such  procedures, 
namely registration, listing, updating, transmission and publication of the lists. 

In  addition,  since  it  is  for  the  Member  States  to  control  the  conditions  that  must  be 
fulfilled  by  the  different  animal  health  establishments  in  order  to  be  listed,  the 
responsibility  for  the  drawing up  of  the  lists  should  lay  with  the  Member  States  and 
not the Commission.  

(5)  Member States should therefore draw up and keep up-to-date lists of the animal health 
establishments concerned and make them available to the other Member States and to 
the public. In order to harmonise the model forms of those lists and the way to achieve 
simple  access  to  up-to-date  lists  for  the  Community,  common  criteria  need  to  be 
established under a comitology procedure. 

(6) 

(7) 

(8) 

(9) 

6 
7 

In  the  interests  of  clarity  and  consistency  of  Community  rules,  this  new  procedure 
should  also  apply  in  the  zootechnical  field,  in  particular  to  breeding  associations 
approved  for  maintaining  or  establishing  herd  books  in  Member  States  and  to 
information  to  be  provided  by  Member  States  regarding  equine  competitions  in 
accordance with Council Directive 90/428/EEC of 26 June 1990 on trade in equidae 
intended for competitions and laying down the conditions for participation therein6.  

Similarly  to  the  rules  applied  to  intra-Community  trade,  imports  of  semen,  ova  and 
embryos are regulated in such a way that the animal health establishments of origin in 
third countries are to fulfil certain conditions in order to minimise animal health risks. 
Accordingly,  imports  into  the  Community  of  such  genetic  materials  should  only  be 
authorised  from  semen  collection  or  storage  centres  and  embryo  collection  or 
production  teams  officially  approved  for  export  to  the  Community  by  the  competent 
authorities  of 
in  accordance  with  Community 
requirements and following Community veterinary inspections, where appropriate.  

third  country  concerned 

the 

Depending on the type of genetic materials and on the species concerned, the current 
procedures for listing animal health establishments and updating the relevant lists are 
different, ranging from decisions adopted under a comitology procedure in accordance 
with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for 
the  exercise  of  implementing  powers  conferred  on  the  Commission7  to  a  simple 
consultation with Member States. 

The  co-existence  of  different  procedures  can  lead  to  confusion  and  uncertainty 
amongst  administrative  officials  in  third  countries,  the  farming  industry  and  trade 
operators.  Since  it  is  for  the  third  countries  to  check  on  the  conditions  that  must  be 
fulfilled by the different animal health establishments in order to be listed as approved 
for export to the Community in accordance with Community requirements, the current 

OJ L 224, 18.8.1990, p. 60. 
OJ L 184, 17.7.1999, p. 23. Decision as last amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, 
p. 11). 

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7 

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legal  framework  for  the  authorisation  of  those  establishments  should  be  harmonised 
and simplified, so that the responsibility for drawing up and updating the lists lies with 
the third countries and not the Commission. It is important to ensure that the level of 
animal  health  guarantees  given  by  the  third  country  concerned  is  not  affected.  The 
simplification measures are without prejudice to the right of the Commission to take 
safeguard measures if necessary. 

(10)  The  different  existing  procedures  should  therefore  be  replaced  by  a  procedure  under 
which  imports  into  the  Community  should  only  be  permitted  from  third  countries  in 
which  competent  authorities  draw  up  and  keep  up-to-date  the  lists  and  communicate 
them  to  the  Commission.  The  Commission  should  inform  the  Member  States  about 
those lists and make them available to the public for information purposes. In the case 
of  concerns  with  regard  to  the  lists  communicated  by  the  third  countries,  safeguard 
measures  are  to  be  adopted  in  accordance  with  Council  Directive  97/78/EC  of  18 
December  1997  laying  down  the  principles  governing  the  organisation  of  veterinary 
checks on products entering the Community from third countries8. 

(11)  For reasons of clarity and consistency of Community legislation, that procedure should 
also  apply  to  authorities  in  third  countries  approved  for  the  purpose  of  keeping  herd 
books,  flock  books  or  studbooks  in  accordance  with  Community  zootechnical 
legislation. 

(12) 

(13) 

In the veterinary field, the Commission is responsible for setting up and updating the 
lists of approved national reference laboratories and other approved laboratories on the 
basis of information provided by the Member States.  

In  accordance  with  existing  Community  legislation,  amendments  to  those  lists  are 
made,  following  a  request  from  a  Member  State  and  a  decision  adopted  under  a 
comitology procedure in accordance with Decision 1999/468/EC, or by the Council on 
a proposal from the Commission.  

(14)  However,  amendments  to  such  lists  are  often  of  a  purely  formal  nature,  such  as 
changes  in  the  contact  details  of  the  national  reference  laboratories  or  the  other 
approved laboratories in question. 

(15)  The  current  practice  has  been  to  make  only  periodic  updates  of  the  lists  of  those 
laboratories to reduce the number of Commission decisions to be taken. However, that 
practice does not guarantee a rapid update of those lists.  This could compromise the 
legal status of national reference laboratories and other approved laboratories. 

(16)  Since the Member States designate the national reference laboratories and provide all 
the necessary details and updates, the responsibility for the drawing up of the lists of 
such  laboratories  should  lay  with  the  Member  States  and  not  the  Commission. 
Similarly, the responsibility for drawing up lists of other approved laboratories should 
lay with the Member States. 

(17)  Member States should therefore draw up and keep up-to-date the lists of the national 
reference  laboratories  and  other  approved  laboratories  concerned  and  make  them 

8 

OJ L 24, 30.1.1998, p. 9. Directive as last amended by Directive 2006/104/EC (OJ L 363, 20.12.2006, 
p. 352). 

EN 

8 

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available to the other Member States and the public. In order to harmonise the model 
of  those  lists  and  the  way  to  achieve  simple  access  to  up-to-date  lists  for  the 
Community, common criteria should be established under the comitology procedure. 

(18)  However, where the lists concern approved laboratories situated in third countries, the 
Commission should continue to be responsible for drawing up and publishing the lists 
of such laboratories. 

(19) 

In  order  to  avoid  any  disruption  concerning  applications  for  approval  of  laboratories 
submitted by Member States pursuant to Council Decision 2000/258/EC of 20 March 
2000 designating a specific institute responsible for establishing the criteria necessary 
for standardising the serological tests to monitor the effectiveness of rabies vaccines9, 
transitional measures should be provided for in this Directive. 

89/556/EEC15, 

(20)  Council  Directives  64/432/EEC10,  77/504/EEC11,  88/407/EEC12,  88/661/EEC13, 
89/361/EEC14, 
90/429/EEC18, 
90/427/EEC16, 
90/539/EEC19,  91/68/EEC20,  92/35/EEC21,  92/65/EEC,  92/66/EEC22,  92/119/EEC23 
and  94/28/EC24,  2000/75/EC25,  Council  Decision  2000/258/EC,  Council  Directives 
2001/89/EC26,  2002/60/EC27,  and  2005/94/EC28  should  therefore  be  amended 
accordingly,  

90/428/EEC17, 

9 

10 
11 

12 

13 

14 
15 

16 
17 
18 
19 
20 
21 
22 
23 

24 
25 
26 
27 
28 

OJ L 79, 30.3.2000, p. 40. Decision as last amended by Commission Decision 2003/60/EC (OJ L 23, 
28.1.2003, p. 30). 
OJ 121, 29.7.1964, p. 1977/64. Directive as last amended by Directive 2006/104/EC.. 
OJ  L  206,  12.8.1977,  p.  8.  Directive  as  last  amended  by  Regulation  (EC)  No  807/2003  (OJ  L  122, 
16.5.2003, p. 36). 
OJ L 194, 22.7.1988, p. 10. Directive as last amended by Commission Decision 2006/16/EC (OJ L 11, 
7.1.2006, p. 21). 
OJ L 382, 31.12.1988, p. 36. Directive as last amended by Regulation (EC) No 806/2003 (OJ L 122, 
16.5.2003, p. 1). 
OJ L 153, 6.6.1989, p. 30. 
OJ L 302, 19.10.1989, p. 1. Directive as last amended by Commission Decision 2006/60/EC (OJ L 31, 
3.2.2006, p. 24). 
OJ L 224, 18.8.1990, p. 55. 
OJ L 224, 18.8.1990, p. 60. 
OJ L 224, 18.8.1990, p. 62. Directive as last amended by Regulation (EC) No 806/2003. 
OJ L 303, 31.10.1990, p. 6. Directive as last amended by Directive 2006/104/EC. 
OJ L 46, 19.2.1991, p. 19. Directive as last amended by Directive 2006/104/EC. 
OJ L 157, 10.6.1992, p. 19. Directive as last amended by Directive 2006/104/EC. 
OJ L 260, 5.9.1992, p. 1. Directive as last amended by Directive 2006/104/EC. 
OJ L 62, 15.3.1993, p. 69. Directive as last amended by Commission Directive 2007/10/EC (OJ L 63, 
1.3.2007, p. 24). 
OJ L 178, 12.7.1994, p. 66. 
OJ L 327, 22.12.2000, p. 74. Directive as last amended by Directive 2006/104/EC. 
OJ L 316, 1.12.2001, p. 5. Directive as last amended by Directive 2006/104/EC. 
OJ L 192, 20.7.2002, p. 27. Directive as last amended by Directive 2006/104/EC. 
OJ L 10, 14.1.2005, p. 16. 

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HAS ADOPTED THIS DIRECTIVE: 

Article 1 
Amendments to Directive 64/432/EEC 

Directive 64/432/EEC is hereby amended as follows: 

(1) 

The following Article 6a shall be inserted: 

"Article 6a 

Member  States  shall  designate  State  Institutes,  National  Reference  Laboratories  or 
Official  Institutes  responsible  for  coordinating  the  standards  and  methods  of 
diagnosis referred to in Annexes A to D. They shall maintain up-to-date lists thereof 
and make them available to the other Member States and to the public. 

The  tasks  and  responsibilities  of  those  State  Institutes,  National  Reference 
Laboratories and Official Institutes are set out in Annexes B and C and Chapter II of 
Annex D.  

Detailed  rules  for  the  uniform  application  of  this  Article  may  be  adopted  in 
accordance with the procedure referred to in Article 17(2)." 

(2) 

In Article 11, paragraph 3 shall be replaced by the following: 

"3.  The  competent  authority  shall  issue  an  approval  number  to  each  approved 
assembly centre. Approvals of assembly centres may be limited to a particular 
species or to animals for breeding and production or to animals for slaughter.  

The competent authority shall draw up and keep up-to-date a list of approved 
assembly centres and their approval numbers and make it available to the other 
Member States and to the public." 

(3) 

In Article 13, the following paragraphs 5 and 6 shall be added: 

"5.  Member States shall draw up and keep up-to-date a list of approved dealers and 
registered premises used by dealers in connection with their business and their 
approval numbers and make that list available to the other Member States and 
to the public.  

6.  Detailed  rules  for  the  uniform  application  of  paragraph  5  may  be  adopted  in 

accordance with the procedure referred to in Article 17(2)." 

(4) 

Annex B shall be amended as follows: 

(a) 

point 4.1 shall be replaced by the following: 

"4.1.  Tasks and responsibilities 

EN 

10 

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The  State  Institutes,  National  Reference  Laboratories  or  Official 
Institutes  designated  in  accordance  with  Article  6a  shall  be  responsible 
for the official testing of tuberculins or reagents referred to in paragraphs 
2 and 3 respectively in their respective Member States to ensure that each 
of  these  tuberculins  or  reagents  is  adequate  in  relation  to  the  standards 
referred to in point 2.1 and paragraph 3 respectively." 

(5) 

(6) 

(b)  point 4.2 shall be deleted.  

In Annex C, point 4.2 shall be deleted. 

In Annex D, Chapter II.A, points 2 and 3 shall be replaced by the following: 

"2.  The  State  Institutes,  National  Reference  Laboratories  or  Official  Institutes 
designated  in  accordance  with  Article  6a  for  coordinating  standards  and 
methods  of  diagnosis  of  the  tests  for  enzootic  bovine  leucosis  must  be  made 
responsible  for  calibrating  the  standard  working  antigen  of  the  laboratory 
against  the  official  EC  standard  serum  (EI  serum)  provided  by  the  National 
Veterinary Institute, Technical University of Denmark. 

3. 

The standard antigens used in the laboratory must be submitted at least once a 
year  to  the  State  Institutes,  National  Reference  Laboratories  or  Official 
Institutes  designated  in  accordance  with  Article  6a,  for  testing  against  the 
official EC standard serum. Apart from such standardisation, the antigen in use 
may be calibrated in accordance with the method described in B." 

Article 2 
Amendments to Directive 77/504/EEC 

The following Article 4a shall be inserted: 

"Article 4a 

1. 

2. 

Member States shall draw up and keep up-to-date a list of breeders' organisations and 
associations  which  are  officially  recognised  for  the  purpose  of  maintaining  or 
establishing herd-books and make it available to the other Member States and to the 
public.  

Detailed  rules  for  the  uniform  application  of  this  Article  may  be  adopted  in 
accordance with the procedure referred to in Article 8(2)." 

Article 3 
Amendments to Directive 88/407/EEC 

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

(1) 

In Article 5, paragraph 2 shall be replaced by the following: 

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"2.  All  semen  collection  or  storage  centres  shall  be  registered,  each  centre  being 
given a veterinary registration number. Each Member State shall draw up and 
keep up-to-date a list of semen collection or storage centres and their veterinary 
registration numbers and make it available to the other Member States and to 
the public. 

3.  Detailed  rules  for  the  uniform  application  of  this  Article  may  be  adopted  in 

accordance with the procedure referred to in Article 18(2)." 

(2) 

Article 9 shall be replaced by the following: 

"Article 9 

1.  Member States shall only authorise imports of semen dispatched from a semen 
collection or storage centre situated in one of the third countries appearing on 
the  list  referred  to  in  Article  8  and  for  which  the  competent  authority  of  the 
third  country  concerned  is  able  to  give  the  guarantees  that  the  following 
conditions are met: 

(a) 

it meets the conditions: 

(i) 

for approval of semen collection centres or storage centres set out 
in Chapter I of Annex A;  

(ii) 

relating  to  the  supervision  of  such  centres  set  out  in  Chapter  II 
thereof; 

(b) 

it  has  been  officially  approved  by  the  competent  authority  of  the  third 
country for exports to the Community; 

(c) 

it is placed under the supervision of a centre veterinarian; 

(d) 

it is subject to inspections by an official veterinarian of the third country 
at least twice a year. 

2. 

The list of semen collection or storages centres that the competent authority of 
the third country appearing on the list referred to in Article 8 has approved in 
accordance with the conditions set out in paragraph 1 of this Article and from 
which semen may be dispatched to the Community shall be communicated to 
the Commission. 

The  approval  of  a  semen  collection  or  storage  centre  must  be  immediately 
suspended or withdrawn by the competent authority of the third country where 
it  no  longer  complies  with  the  conditions  set  out  in  paragraph  1  and  the 
Commission must be immediately informed thereof. 

The Commission shall provide the Member States with any new and updated 
lists  that  it  receives  from  the  competent  authority  of  the  third  country  in 
accordance with this paragraph and shall make them available to the public for 
information purposes. 

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3.  Detailed  rules  for  the  uniform  application  of  this  Article  may  be  adopted  in 

accordance with the procedure referred to in Article 18(2)." 

(3) 

Article 12 shall be replaced by the following: 

"Article 12 

The  rules  laid  down  in  Directive  97/78/EC  shall  apply,  in  particular  to  the 
organisation of, and follow-up to, the checks to be carried out by the Member States 
and the safeguard measures to be applied in accordance with the procedure referred 
to in Article 22 of that Directive." 

Article 4 
Amendments to Directive 88/661/EEC 

The following Article 4a shall be inserted: 

"Article 4a 

Member  States  shall  draw  up  and  keep  up-to-date  a  list  of  breeders'  associations  and/or 
breeding organizations as referred to in Article 1(c) and make it available to the other Member 
States and to the public.  

Detailed rules for the uniform application of this Article may be adopted in accordance with 
the procedure referred to in Article 11(2)." 

Article 5 
Amendments to Directive 89/361/EEC 

Article 5 of Directive 89/361/EEC shall be replaced by the following: 

"Article 5 

Member  States  shall  draw  up  and  keep  up-to-date  a  list  of  breeders’  organisations  and 
associations which are officially approved for the purpose of maintaining or establishing flock 
books and which meet the criteria determined in accordance with the first indent of Article 4 
and make it available to the other Member States and to the public.  

Detailed rules for the uniform application of this Article may be adopted in accordance with 
the procedure referred to in Article 8." 

Article 6 
Amendments to Directive 89/556/EEC  

Directive 89/556/EEC is hereby amended as follows: 

(1) 

In Article 5(2), the first subparagraph, shall be replaced by the following: 

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"2.  The  competent  authority  of  each  Member  State  concerned  shall  register 
embryo  collection  teams  and  give  a  veterinary  registration  number  to  each 
team.  

Each  Member  State  shall  draw  up  and  keep  up-to-date  a  list  of  embryo 
collection teams and their veterinary registration numbers and make it available 
to the other Member States and to the public." 

(2) 

Article 8 shall be replaced by the following: 

"Article 8 

1.  Member  States  shall  only  authorise  imports  of  embryos  dispatched  from  an 
embryo  collection  or  production  team  situated  in  one  of  the  third  countries 
appearing  on  the  list  referred  to  in  Article  7  and  for  which  the  competent 
authority of the third country concerned is able to give the guarantees that the 
following conditions are met: 

(a) 

it meets the conditions: 

(i) 

for the approval of embryo collection and embryo production teams 
set out in Chapter I of Annex A;  

(ii) 

relating  to  the  collection,  processing,  storage  and  transport  of 
embryos by such teams set out in Chapter II of that Annex; 

it  has  been  officially  approved  by  the  competent  authority  of  the  third 
country for exports to the Community; 

it is subject to inspections by an official veterinarian of the third country 
at least twice a year. 

(b) 

(c) 

2. 

The list of embryo collection or production teams that the competent authority 
of the third country appearing on the list referred to in Article 7 has approved 
in  accordance  with  the  conditions  set  out  in  paragraph  1  of  this  Article  and 
from  which  embryos  may  be  dispatched  to  the  Community  shall  be 
communicated to the Commission. 

The approval of an embryo collection or production team must be immediately 
suspended or withdrawn by the competent authority of the third country where 
it  no  longer  complies  with  the  conditions  set  out  in  paragraph  1  and  the 
Commission must be immediately informed thereof. 

The Commission shall provide the Member States with any new and updated 
lists  that  it  receives  from  the  competent  authority  of  the  third  country 
concerned in accordance with this paragraph and shall make them available to 
the public for information purposes. 

3.  Detailed  rules  for  the  uniform  application  of  this  Article  may  be  adopted  in 

accordance with the procedure referred to in Article 18(2)." 

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(3) 

Article 11 is replaced by the following: 

"Article 11 

The  rules  laid  down  in  Directive  97/78/EC  shall  apply,  in  particular  to  the 
organisation of, and follow-up to, the checks to be carried out by the Member States 
and the safeguard measures to be applied in accordance with the procedure referred 
to in Article 22 of that Directive." 

Article 7 
Amendments to Directive 90/427/EEC 

Article 5 of Directive 90/427/EEC shall be replaced by the following: 

"Article 5 

Member  States  shall  draw  up  and  keep  up-to-date  the  list  of  organisations  and  associations 
maintaining or establishing studbooks, which are approved or recognised on the basis of the 
criteria  determined  in  accordance  with  Article  4(2)(a)  and  make  it  available  to  the  other 
Member States and to the public. 

Detailed rules for the uniform application of this Article may be adopted in accordance with 
the procedure referred to in Article 10." 

Article 8 
Amendments to Directive 90/428/EEC 

In Article 4 of Directive 90/428/EEC, paragraph 2 shall be replaced by the following: 

"2. 

However, 

– 

the obligations referred to in Article 3 shall not affect the organization of: 

(a) 

competitions  reserved  for  equidae  registered  in  a  specific  studbook  for 
the purpose of permitting the improvement of the breed; 

(b) 

regional competitions with a view to selecting equidae; 

(c) 

historic or traditional events. 

Member States intending to avail themselves of these possibilities shall make 
this intention and the justifications thereof available to the other Member States 
and to the public beforehand. 

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– 

for each competition or type of competition Member States shall be authorized 
to  reserve,  through  the  bodies  officially  approved  or  recognized  for  that 
purpose,  a  certain  percentage  of  the  prize  money  or  profits  referred  to  in 
paragraph 1(c) for the safeguard, development and improvement of breeding.  

The percentage may not exceed 20 % from 1993. 

The criteria for the distribution of these funds in the Member State concerned 
shall be made available to the other Member States and to the public." 

Article 9 
Amendments to Directive 90/429/EEC  

Directive 90/429/EEC is hereby amended as follows: 

(1) 

In Article 5, paragraph 2 shall be replaced by the following: 

"2.  All  semen  collection  centres  shall  be  registered,  each  centre  being  given  a 

veterinary registration number.  

Each  Member  State  shall  draw  up  and  keep  up-to-date  a  list  of  semen 
collection  centres  and  their  veterinary  registration  numbers  and  make  it 
available to the other Member States and to the public." 

(2) 

Article 8 shall be replaced by the following: 

"Article 8 

1.  Member States shall only authorise imports of semen dispatched from a semen 
collection  centre  situated  in  one  of  the  third  countries  appearing  on  the  list 
referred  to  in  Article  7  and  for  which  the  competent  authority  of  the  third 
country concerned is able to give the guarantees that the following conditions 
are met: 

(a) 

it meets the conditions: 

(i) 

for the approval of semen collection centres set out in Chapter I of 
Annex A;  

(ii) 

relating  to  the  supervision  of  such  centres  set  out  in  Chapter  II 
thereof; 

(b) 

it  has  been  officially  approved  by  the  competent  authority  of  the  third 
country for exports to the Community; 

(c) 

it is placed under the supervision of a centre veterinarian; 

(d) 

it is subject to inspections by an official veterinarian of the third country 
concerned at least twice a year. 

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2. 

The  list  of  semen  collection  centres  that  the  competent  authority  of  the  third 
country  appearing  on  the  list  referred  to  in  Article  7  has  approved  in 
accordance with the conditions set out in paragraph 1 of this Article and from 
which semen may be dispatched to the Community shall be communicated to 
the Commission. 

The approval of a semen collection centre must be immediately suspended or 
withdrawn by the competent authority of the third country where it no longer 
complies with the conditions set out in paragraph 1 and the Commission must 
be immediately informed thereof. 

The Commission shall provide the Member States with any new and updated 
lists  that  it  receives  from  the  competent  authority  of  the  third  country 
concerned in accordance with this paragraph and shall make them available to 
the public for information purposes. 

3.  Detailed  rules  for  the  uniform  application  of  this  Article  may  be  adopted  in 

accordance with the procedure referred to in Article 18(2)." 

(3) 

In Article 15, paragraph 2 shall be replaced by the following: 

"2.  The  rules  laid  down  in  Directive  97/78/EC  shall  apply,  in  particular  to  the 
organisation of, and follow-up to, the checks to be carried out by the Member 
States  and  the  safeguard  measures  to  be  applied  in  accordance  with  the 
procedure referred to in Article 22 of that Directive." 

Article 10 
Amendments to Directive 90/539/EEC  

Directive 90/539/EEC is hereby amended as follows 

(1) 

Article 4 shall be replaced by the following: 

"Article 4 

Each Member State shall designate a national reference laboratory to be responsible 
for coordinating the diagnostic methods provided for in this Directive and their use 
by the approved laboratories located in its territory. 

Each  Member  State  shall  make  the  details  of  its  national  reference  laboratory,  and 
any subsequent changes, available to the other Member States and to the public. 

Detailed  rules  for  the  uniform  application  of  this  Article  may  be  adopted  in 
accordance with the procedure referred to in Article 32(2)." 

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(2) 

The following Article 6a shall be inserted:  

"Article 6a 

Each  Member  State  shall  draw  up  and  keep  up-to-date  a  list  of  establishments 
approved in accordance with point 1(a) of Article 6 and their distinguishing numbers, 
and shall make it available to the other Member States and to the public. 

Detailed  rules  for  the  uniform  application  of  this  article  may  be  adopted  in 
accordance with the procedure referred to in Article 32." 

(3) 

Annex I shall be amended as follows: 

(i) 

point 1 shall be deleted. 

(ii)  point 2 shall be replaced by the following: 

"2.  The  national  reference  laboratories  for  avian  diseases  designated  in 
accordance with Article 4 shall be responsible in each Member State for 
coordinating  the  diagnostic  methods  provided  for  in  this  Directive.  To 
this end: 

(a) 

(b) 

they may supply approved laboratories with the reagents needed for 
diagnostic testing; 

they  shall  monitor  the  quality  of  all  the  reagents  used  by  the 
approved laboratories; 

(c) 

they shall organize periodic comparative tests." 

Article 11 
Amendments to Directive 91/68/EEC 

Directive 91/68/EEC is hereby amended as follows: 

(1) 

In Article 8a, paragraph (3) shall be replaced by the following: 

"(3)  The  competent  authority  shall  issue  an  approval  number  to  each  approved 
assembly centre. Approvals may be limited to one or more species covered by 
this  Directive  or  to  animals  for  breeding  or  fattening,  or  to  animals  for 
slaughter.  

The competent authority shall draw up and keep up-to-date a list of approved 
assembly centres and their unique approval numbers and make it available to 
the other Member States and to the public." 

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(2) 

In Article 8b, the following paragraph 5 shall be added: 

"(5)  Member States shall draw up and keep up-to-date a list of approved dealers and 
registered premises used by dealers in connection with their business and their 
approval numbers and shall make it available to the other Member States and 
to the public.  

Detailed rules for the uniform application of this paragraph may be adopted in 
accordance with the procedure referred to in Article 15(2)." 

Article 12 
Amendments to Directive 92/35/EEC  

Directive 92/35/EEC is hereby amended as follows 

(1) 

Article 14 shall be replaced by the following: 

"Article 14 

1.  Member States shall designate a national laboratory to carry out the laboratory 
examinations provided for in this Directive, and shall make the details of that 
laboratory, and any subsequent changes, available to the other Member States 
and to the public. 

Detailed rules for the uniform application of this paragraph may be adopted in 
accordance with the procedure referred to in Article 19. 

The functions and duties of the national laboratories designated in accordance 
with paragraph 1 are set out in Annex I.  

The national laboratories designated in accordance with paragraph 1 shall liaise 
with the Community reference laboratory referred to in Article 15." 

2. 

3. 

(2) 

In Annex I, Section A shall be deleted. 

Article 13 
Amendments to Directive 92/65/EEC 

Directive 92/65/EEC is hereby amended as follows: 

(1) 

In Article 11, the following paragraph 5 shall be added: 

"5.  The  approved  centres  referred  to  in  the  first  indent  of  paragraph  2  and  the 
approved collection teams referred to in the first indent of paragraph 3 shall be 
registered  by  the  competent  authority  of  the  Member  State  concerned,  each 
centre and team being given a veterinary registration number. 

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Each Member State shall draw up and keep up-to-date a list of those approved 
centres and approved collection teams and their veterinary registration numbers 
and shall make it available to the other Member States and to the public.  

Detailed rules for the uniform application of this paragraph may be adopted in 
accordance with the procedure referred to in Article 26(2)." 

(2) 

In Article 13(2), point (d) shall be replaced by the following: 

"(d)  All approved bodies, institutes and centres shall be registered and issued with 

an approval number by the competent authority.  

Each  Member  State  shall  draw  up  and  keep  up-to-date  a  list  of  approved 
bodies,  institutes  and  centres  and  their  approval  numbers  and  shall  make  it 
available to the other Member States and to the public. 

Detailed  rules  for  the  uniform  application  of  this  point  may  be  adopted  in 
accordance with the procedure referred to in Article 26(2)." 

(3) 

In Article 17, paragraph 3 shall be replaced by the following: 

"3.  The following shall be established: 

(a) 

(b) 

in  accordance  with  the  procedure  referred  to  in  Article  26(2),  a  list  of 
third countries or parts of third countries able to provide Member States 
and the Commission with guarantees equivalent to those provided for in 
Chapter II in relation to animals, semen, ova and embryos; 

in  accordance  with  this  point,  a  list  of  approved  centres  or  collection 
teams as referred to in the first indent  of  paragraph  2  of  Article  11  and 
the first indent of paragraph 3 of that article situated in one of the third 
countries  appearing  on  the  list  referred  to  in  point  (a)  of  this  paragraph 
and  for  which  the  competent  authority  is  able  to  give  the  guarantees 
provided for in Article 11(2) and (3). 

The list of approved centres and collection teams referred to in the first 
subparagraph  and 
their  veterinary  registration  numbers  shall  be 
communicated to the Commission.  

The  approval  of  a  collection  centre  or  team  must  be  immediately 
suspended or withdrawn by the competent authority of the third country 
where  it  no  longer  complies  with  the  conditions  referred  to  in  Article 
11(2)  and  (3)  and  the  Commission  must  be  immediately  informed 
thereof. 

The  Commission  shall  provide  the  Member  States  with  any  new  and 
updated  lists  that  it  receives  from  the  competent  authority  of  the  third 
country in accordance with the second and third subparagraphs and shall 
make them available to the public for information purposes.  

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Detailed rules for the uniform application of this point may be adopted in 
accordance with the procedure referred to in Article 26(2). 

(c) 

in accordance with the procedure referred to in Article 26(2), the specific 
animal  health  requirements,  in  particular  for  the  protection  of  the 
Community  from  certain  exotic  diseases,  or  guarantees  equivalent  to 
those provided for in this Directive. 

The specific requirements and equivalent guarantees established for third 
countries  may  not  be  more  favourable  than  those  provided  for  in 
Chapter II." 

(4) 

In Article 20, the first paragraph shall be replaced by the following: 

"The  rules  laid  down  in  Directive97/78/EC  shall  apply  in  particular  to  the 
organisation of, and follow-up to, the checks to be carried out by the Member States 
and the safeguard measures to be applied in accordance with the procedure referred 
to in Article 22 of that Directive." 

Article 14 
Amendments to Directive 92/66/EEC 

Directive 92/66/EEC is hereby amended as follows: 

(1) 

Article 14 is amended as follows: 

(a)  Paragraph 2 shall be replaced by the following: 

"2.  The national laboratories referred to in paragraph 1 shall be responsible 
for coordinating standards and methods of diagnosis, use of reagents and 
testing of vaccines." 

(b) 

In paragraph 3, the introductory phrase shall be replaced by the following: 

"3.  The national laboratories referred to in paragraph 1 shall be responsible 
for coordinating the standards and diagnostic methods laid down in each 
Newcastle-disease  diagnostic  laboratory  within  the  Member  State.  To 
this end:" 

(c)  Paragraph 4 shall be replaced by the following: 

"4.  The national laboratories referred to in paragraph 1 shall liaise with the 

Community reference laboratory referred to in Article 15. 

5.  Member States shall maintain up-to-date lists of the national laboratories 
or  institutes  referred  to  in  paragraph  1  and  make  them  available  to  the 
other Member States and to the public.  

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Detailed  rules  for  the  uniform  application  of  this  paragraph  may  be 
adopted in accordance with the procedure referred to in Article 25(2)." 

(2) 

Annex IV shall be deleted. 

Article 15 
Amendments to Directive 92/119/EEC 

Directive 92/119/EEC is hereby amended as follows: 

(1) 

In Article 17, paragraph 5 shall be replaced by the following: 

"5.  Member  States  shall  maintain  up-to-date  lists  of  the  national  laboratories 
referred to in paragraph 1 and make them available to the other Member States 
and to the public." 

(2) 

In Annex II, point 5 shall be deleted. 

Article 16 
Amendments to Directive 94/28/EC 

Directive 94/28/EC is hereby amended as follows: 

(1) 

In Article 3, paragraph 1 shall be replaced by the following:  

"1.  A  list  of  authorities  in  respect  of  the  species  and/or  races  concerned  that  the 
competent authority  of the third  country has approved for the purpose of this 
Directive shall be communicated to the Commission.  

The approval of an authority must be immediately suspended or withdrawn by 
the competent authority of the third country where it no longer complies with 
the  conditions  referred  to  in  Article  3(2)(b)  and  the  Commission  must  be 
immediately informed thereof. 

The Commission shall provide the Member States with  any  new and updated 
lists  that  it  receives  from  the  competent  authority  of  the  third  country 
concerned  in  accordance  with  the  second  subparagraph  and  shall  make  them 
available to the public for information purposes." 

(2) 

Article 3 shall be amended as follows: 

(a) 

In paragraph 2, point (a) shall be deleted; 

(b)  Paragraph 3 shall be deleted. 

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(3) 

In Article 10, the following paragraph shall be added: 

"Where any serious infringement to the provisions in Article 3(2)(b) so warrants, in 
particular in the light of findings in relation to on-the-spot checks referred to in the 
first  paragraph  of  this  Article,  measures  may  be  adopted  to  suspend  the  import  of 
animals, semen, ova and embryos referred to in Article 1(1) in accordance with the 
procedure referred to in Article 12." 

Article 17 
Amendments to Directive 2000/75/EC 

Directive 2000/75/EC is hereby amended as follows: 

(1) 

Article 15 shall be replaced by the following: 

"Article 15 

1.  Member  States  shall  designate  a  national  laboratory  responsible  for  carrying 
out  the  laboratory  tests  provided  for  by  this  Directive,  and  shall  make  the 
details  of  that  laboratory,  and  any  subsequent  changes,  available  to  the  other 
Member States and to the public. 

Detailed rules for the uniform application of this paragraph may be adopted in 
accordance with the procedure referred to in Article 20(2). 

The tasks of the national laboratories designated in accordance with paragraph 
1 are listed in Annex I.  

The  national  laboratories  designated  in  accordance  with  paragraph  1  of  this 
Article  shall  liaise  with  the  Community  reference  laboratory  referred  to  in 
Article 16." 

2. 

3. 

(2) 

In Annex I, Section A shall be deleted. 

Article 18 
Amendments to Decision 2000/258/EC  

Decision 2000/258/EC is hereby amended as follows:  

(1) 

Article 3 shall be replaced by the following: 

"Article 3 

1.  On the basis of a favourable result of the appraisal of an applicant laboratory in 
a  Member  State,  documented  by  AFSSA,  Nancy,  the  competent  authority  of 
the  Member  State  may  authorise  the  applicant  laboratory  to  carry  out  the 
serological tests to monitor the effectiveness of rabies vaccines.  

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Member  States  shall  draw  up  and  keep  up-to-date  a  list  of  those  laboratories 
that  they  have  authorised  and  shall  make  it  available  to  the  other  Member 
States and to the public. 

2.  On the basis of a favourable result of the appraisal of an applicant laboratory in 
a  third  country  documented  by  AFSSA,  Nancy,  and  following  an  application 
for approval from the competent authority of the third country of origin of the 
applicant laboratory, such laboratory shall be authorised in accordance with the 
procedure referred to in Article 5(2) to carry out serological tests to monitor the 
effectiveness of rabies vaccines.  

3.  Detailed  rules  for  the  uniform  application  of  this  Article  may  be  adopted  in 

accordance with the procedure referred to in Article 5(2)." 

(2) 

Annexes I and II shall be replaced by the text in the Annex to this Directive. 

Article 19 
Amendments to Directive 2001/89/EC 

Directive 2001/89/EC is hereby amended as follows: 

(1) 

In Article 17(1), point (b) shall be replaced by the following: 

"(b)  a national laboratory is responsible for coordinating standards and methods of 
diagnosis  in  each  Member  State  in  accordance  with  the  provisions  of  Annex 
III. 

Member  States  shall  make  the  details  of  their  national  laboratory,  and  any 
subsequent changes, available to the other Member States and to the public in a 
manner that may be specified in accordance with the procedure referred to in 
Article 26(2)." 

(2) 

Annex III shall be amended as follows: 

(a) 

the title shall be replaced by the following: 

"Duties of national laboratories for classical swine fever" 

(b)  point 1 shall be deleted. 

Article 20 
Amendments to Directive 2002/60/EC 

Directive 2002/60/EC is hereby amended as follows: 

(1) 

In Article 18(1), point (b) shall be replaced by the following: 

"(b)  a  national  laboratory  is  responsible  for  coordinating  standards  and  diagnostic 

methods in each Member State in accordance with Annex IV.  

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Member  States  shall  make  the  details  of  their  national  laboratory,  and  any 
subsequent changes, available to the other Member States and to the public in a 
manner that may be specified in accordance with the procedure referred to in 
Article 23(2)." 

(2) 

Annex IV shall be amended as follows: 

(a) 

the title shall be replaced by the following: 

"Duties of national laboratories for African swine fever" 

(b)  Point 1 shall be deleted. 

Article 21 
Amendments to Directive 2005/94/EC 

In Article 51of Directive 2005/94/EC, paragraph 2 shall be replaced by the following: 

"2. 

1. 

Member  States  shall  designate  a  national  reference  laboratory  and  shall  make  the 
details thereof, and any subsequent changes, available to the other Member State and 
to  the  public  in  a  manner  that  may  be  specified  in  accordance  with  the  procedure 
referred to in Article 64(2)." 

Article 22 
Transposition  

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative 
provisions necessary to comply with this Directive by 1 July 2009 at the latest. They 
shall  forthwith  communicate  to  the  Commission  the  text  of  those  provisions  and  a 
correlation table between those provisions and this Directive. 

When  Member  States  adopt  those  provisions,  they  shall  contain  a  reference  to  this 
Directive or shall be accompanied by such reference on the occasion of their official 
publication. Member States shall determine how such reference is to be made. 

2. 

Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by the Directive. 

Article 23 
Transitional provisions  

Applications  for  approval  of  laboratories  submitted  by  the  Member  States  prior  to  1  July 
2009, in accordance with Article 3 of Decision 2000/258/EC and Annex II thereto, shall be 
governed by that Decision, as worded before the amendments made by this Directive. 

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Article 24 
Entry into force  

This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union.  

Article 25 
Addressees 

This Directive is addressed to the Member States. 

Done at Brussels, 

For the Council 
The President 

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ANNEX  

"ANNEX I 

AFSSA, Nancy 
Laboratoire d’études sur la rage et la pathologie des animaux sauvages 
Technopôle Agricole et Vétérinaire 
BP 40 009 
54220 Malzéville Cedex  
France 

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ANNEX II 

The specific institute responsible for establishing the criteria necessary for standardising the 
serological test to monitor the action of rabies vaccines shall: 

– 

– 

– 

– 

– 

– 

coordinate  the  establishment,  improvement  and  standardisation  of  methods  of 
serological titration on carnivores vaccinated against rabies; 

appraise those laboratories in Member States which have submitted an application to 
perform  the  serological  titrations  referred  to  in  the  first  indent;  the  result  of  this 
appraisal must be sent to the applicant laboratory and to the competent authorities of 
the Member State where the result is favourable for the purposes of approval; 

appraise those laboratories in third countries which have submitted an application to 
perform  the  serological  titrations  referred  to  in  the  first  indent;  the  result  of  this 
appraisal must be sent to the applicant laboratory and to the Commission where the 
result is favourable for the purpose of approval; 

provide any useful information on analysis methods and comparative trials to those 
laboratories and organise training sessions and further training courses for their staff; 

organise inter-laboratory aptitude tests (proficiency tests); 

provide  scientific  and  technical  assistance  to  the  Commission  and  the  competent 
authorities concerned on the matters referred to in this Annex, in particular in cases 
of disagreement on results of serological titrations." 

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