Council Directive 2008/73/EC of 15 July 2008 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, 90/426/EEC, 90/427/EEC, 90/428/EEC, 90/429/EEC, 90/539/EEC, 91/68/EEC, 91/496/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)
Date: 2008-07-15
Institutions: Council of the European Union
Subjects: administrative formalities, agricultural holding, agricultural production, database, information system, livestock farming, veterinary inspection

L 219/40

EN

Official Journal of the European Union

14.8.2008

DIRECTIVES

COUNCIL DIRECTIVE 2008/73/EC

of 15 July 2008

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,
91/68/EEC,
90/428/EEC,
91/496/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

90/426/EEC,

90/427/EEC,

90/429/EEC,

90/539/EEC,

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

procedures, namely registration,
mission and publication of the lists.

listing, updating, trans­

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

establishing the European

Having regard to the proposal from the Commission,

Having regard to the Opinion of the European Parliament,

Having regard to the Opinion of the European Economic and
Social Committee,

Whereas:

(1)

(2)

Community legislation in the veterinary field provides
that assembly centres for bovine, porcine, caprine and
ovine animals, equine marshalling centres, dealers of
those animals, poultry establishments, semen collection
or storage centres and embryo collection or production
teams and certain bodies, institutes and centres (‘animal
health establishments’)
to comply with certain
are
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.

Community legislation provides for different procedures
with regard to the registration,
listing, updating, trans­
mission and publication of those animal health estab­
lishments. 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)

Therefore those procedures should be harmonised and
provide for more systematic, coherent and uniform
rules with regard to the five key elements of such

(4)

(5)

(6)

(7)

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 lie
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 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.

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
in
accordance with Council Directive 90/428/EEC of
26 June 1990 on trade in equidae intended for compe­
titions and laying down the conditions for participation
therein (1).

competitions

regarding

equine

States

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
officially
embryo
the
approved for
competent authorities of the third country concerned in
accordance with Community requirements and following
Community veterinary inspections, where appropriate.

to the Community by

production teams

collection

export

or

(1) OJ L 224, 18.8.1990, p. 60.

(8)

(9)

(10)

14.8.2008

EN

Official Journal of the European Union

L 219/41

the current procedures for

Depending on the type of genetic materials and on the
species concerned,
listing
animal health establishments and updating the relevant
lists are different, ranging from decisions adopted under a
in accordance with Council
comitology procedure
Decision 1999/468/EC of 28 June 1999 laying down
the procedures for the exercise of implementing powers
conferred on the Commission (1) to a simple consultation
with Member States.

from third countries (3) provides that in the case where
animals imported from third countries are placed in a
quarantine centre within Community territory, this quar­
antine centre must be approved and the list of quarantine
centres published in the Official Journal of the European
Union.
In the interests of clarity and consistency of
Community rules, a simplified procedure should also
apply to the updating of the list of quarantine centres
in the Member States.

amongst

The co-existence of different procedures can lead to
confusion
administrative
uncertainty
and
the farming industry and
officials in third countries,
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
to the Community in
listed as approved for export
accordance with Community requirements, the current
legal
framework for the authorisation of those estab­
lishments 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
are without
simplification measures
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 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
them
those
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
from third
countries (2).

Community

and make

entering

about

lists

the

(11)

For reasons of clarity and consistency of Community
legislation, that procedure should also apply to authori­
ties in third countries approved for
the purpose of
keeping herd books,
flock books or stud books in
accordance with Community zootechnical legislation.

(12)

Council Directive 91/496/EEC of 15 July 1991 laying
down the principles governing the organisation of
veterinary checks on animals entering the Community

(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).

(13)

(14)

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 Community legislation, amendments
to those lists are made,
from a
Member State and a decision adopted under a comi­
tology
accordance with Decision
1999/468/EC, or by the Council on a proposal from
the Commission.

following a request

procedure

in

(15) 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.

(16)

(17)

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.

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

(18) 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
available to the other Member States and the public. In
order to harmonise the model of those lists and the way
the
to achieve simple access to up-to-date lists for
Community, common criteria should be established
under the comitology procedure.

(2) OJ L 24, 30.1.1998, p. 9. Directive as last amended by Directive

(3) OJ L 268, 24.9.1991, p. 56. Directive as last amended by Directive

2006/104/EC (OJ L 363, 20.12.2006, p. 352).

2006/104/EC.

L 219/42

EN

Official Journal of the European Union

14.8.2008

(19) 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.

(20)

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
vaccines (1),
transitional measures should be provided
for in this Directive.

for

that

bovine

animals

breeding

(21) Article 6(2)(a) of Council Directive 64/432/EEC of
26 June 1964 on animal health problems affecting
intra-Community trade in bovine animals and swine (2)
and
provides
production intended for intra-Community trade must
come from an officially tuberculosis-free herd and,
if
more than six weeks old, have reacted negatively to an
intradermal tuberculin test carried out during the 30 days
prior to leaving the herd of origin. Due to traditional
farming and trade practices, some Member States have
encountered difficulties
to comply with this pre-
movement testing. It is therefore necessary to provide
for
the intradermal
tuberculin test at a place other than the holding of
origin to be established under the comitology procedure.

the possibility of carrying out

(22) Moreover, certain Annexes

to Directive 64/432/EEC,
which are of purely technical nature such as those
relating to animal health tests, the list of compulsory
the animal health certificates,
notifiable diseases or
should be amended by means of
comitology
procedure to be able to rapidly take account of new
scientific developments. However,
the amendment of
Annexes laying down detailed conditions with regard
to the disease-free status, which may have an impact
on intra-Community trade, should be reserved for the
Council.

the

(23)

Technological and scientific developments have taken
place since the beginning of the 1990s in the collection
genetic materials. Council
and the production of
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 in

It

therefore appropriate

to Directive 90/425/EEC (3) has not been
Annex A(I)
updated to take account of this evolution and of the
new OIE standards.
to
is
amend the said Directive and to bring into its scope,
provisions in respect of trade in and imports of genetic
material derived from animals other than those of the
ovine, caprine, equine and porcine species. Further,
pending the establishment of detailed harmonised rules
in this field, Member States should be allowed to apply
national rules. Similarly, pending the establishment of
detailed harmonised rules
imports of
animals
covered by that Directive, Member States
should be allowed to apply national rules.

in respect of

The Council, in accordance with point 34 of the Inter­
institutional Agreement on better law-making (4), should
encourage the Member States to draw up, for themselves
and in the interest of the Community their own tables,
which will, as far as possible,
illustrate the correlation
between the Directive and the transposition measures
and to make them public.

Directives

64/432/EEC,

90/429/EEC (12),

88/661/EEC (7),
90/426/EEC (10),

77/504/EEC (5),
Council
89/361/EEC (8),
88/407/EEC (6),
90/427/EEC (11),
89/556/EEC (9),
90/539/EEC (13),
90/428/EEC,
91/68/EEC (14), 91/496/EEC, 92/35/EEC (15), 92/65/EEC,
94/28/EC (18),
92/119/EEC (17),
92/66/EEC (16),
2000/75/EC (19),
Council
Decision
2001/89/EC (20),
and
Directives
2005/94/EC (22)
amended
should
accordingly,

2002/60/EC (21),

2000/258/EC,

therefore

be

(24)

(25)

(3) 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).
(4) OJ C 321, 31.12.2003, p. 1. Corrected by OJ C 4, 8.1.2004, p. 7.
(5) 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).

(6) OJ L 194, 22.7.1988, p. 10. Directive as

last amended by
Commission Decision 2008/120/EC (OJ L 42, 16.2.2008, p. 63).
(7) OJ L 382, 31.12.1988, p. 36. Directive as last amended by Regu­

lation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

(8) OJ L 153, 6.6.1989, p. 30.
(9) 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).
(10) OJ L 224, 18.8.1990, p. 42. Directive as last amended by Directive

2006/104/EC.

(11) OJ L 224, 18.8.1990, p. 55.
(12) OJ L 224, 18.8.1990, p. 62. Directive as last amended by Regu­

lation (EC) No 806/2003.

(13) OJ L 303, 31.10.1990, p. 6. Directive as

last amended by
Commission Decision 2007/729/EC (OJ L 294, 13.11.2007, p. 26).
(14) OJ L 46, 19.2.1991, p. 19. Directive as last amended by Directive

2006/104/EC.

(15) OJ L 157, 10.6.1992, p. 19. Directive as

last amended by

Commission Decision 2007/729/EC.

(16) OJ L 260, 5.9.1992, p. 1. Directive as last amended by Directive

2006/104/EC.

(17) 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).

(18) OJ L 178, 12.7.1994, p. 66.
(19) OJ L 327, 22.12.2000, p. 74. Directive as last amended by

Commission Decision 2007/729/EC.

(20) OJ L 316, 1.12.2001, p. 5. Directive as

last amended by

(1) OJ L 79, 30.3.2000, p. 40. Decision as last amended by Commission

Commission Decision 2007/729/EC.

Decision 2003/60/EC (OJ L 23, 28.1.2003, p. 30).

(21) OJ L 192, 20.7.2002, p. 27. Directive as

last amended by

(2) OJ 121, 29.7.1964, p. 1977/64. Directive as last amended by
Commission Decision 2007/729/EC (OJ L 294, 13.11.2007, p. 26).

Commission Decision 2007/729/EC.

(22) OJ L 10, 14.1.2006, p. 16.

14.8.2008

EN

Official Journal of the European Union

L 219/43

HAS ADOPTED THIS DIRECTIVE:

Article 1

Amendments to Directive 64/432/EEC

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

1.

in Article 6, the first subparagraph of paragraph 2(a) shall be
replaced by:

‘come from an officially tuberculosis-free bovine herd, and in
the case of animals more than six weeks old, have reacted
negatively to an intradermal tuberculin test carried out in
accordance with the provisions of point 2.2 of Annex B
either during the 30 days prior to leaving the herd of
origin or in a place and under conditions to be defined in
accordance with the procedure referred to in Article 17.’;

2. the following Article shall be inserted:

‘Article 6a

shall designate State institutes, national
Member States
institutes responsible for
reference laboratories or official
and methods of diagnosis
coordinating the
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.

standards

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 paragraph
6.
5 may be adopted in accordance with the procedure referred
to in Article 17(2).’;

5. Article 16 shall be replaced by the following:

‘Article 16

Annexes A and D (Chapter I) shall be amended by the
Council, acting by a qualified majority on a Commission
proposal,
in particular with regard to their adaptation to
technological and scientific developments.

Annexes B, C, D (Chapter II), E and F shall be amended by
the Commission in accordance with the procedure referred
to in Article 17.’;

6. Annex B shall be amended as follows:

(a) point 4.1 shall be replaced by the following:

‘4.1. Tasks and responsibilities

in

institutes

designated

The State institutes, national reference laboratories or
official
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.’;

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

(b) point 4.2 shall be deleted;

7. Annex C shall be amended as follows:

3.

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

The competent authority shall

‘3.
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.’;

4.

in Article 13, the following paragraphs 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.

(a)

in point 4.1, the introductory sentence shall be replaced
by the following:

‘National reference laboratories designated in accordance
with Article 6a shall be responsible for:’;

(b) point 4.2 shall be deleted;

8.

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

in

institutes

‘2. The State institutes, national reference laboratories or
official
accordance with
designated
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.

L 219/44

EN

Official Journal of the European Union

14.8.2008

reference

3. The standard antigens used in the laboratory must be
submitted at least once a year to the State institutes,
national
institutes
for testing
designated in accordance with Article 6a,
from
the official EC standard serum. Apart
against
such standardisation, the antigen in use may be cali­
brated in accordance with the method described in B.’.

laboratories or official

(ii) relating to the supervision of such centres set out in

Chapter II thereof;

(b) it has been officially approved by the

the third country for exports

competent
to the

authority of
Community;

Article 2

(c)

it is placed under the supervision of a centre veterinarian;

Amendments to Directive 77/504/EEC

The following Article shall be inserted in Directive 77/504/EEC:

‘Article 4a

1. Member States shall draw up and keep up to date a list
of bodies as referred to in Article 1(b), first indent, which are
officially recognised for the purpose of maintaining or estab­
lishing herd books and make it available to the other Member
States and to the public.

2.
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:

(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
in paragraph 1 and the
set out
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.

All

storage centres

semen collection or

‘2.
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.

Detailed rules for

3.
this
Article may be adopted in accordance with the procedure
referred to in Article 18(2).’;

the uniform application of

2. Article 9 shall be replaced by the following:

Detailed rules for

this
3.
Article may be adopted in accordance with the procedure
referred to in Article 18(2).’;

the uniform application of

3. Article 12 shall be replaced by the following:

‘Article 12

in
The rules laid down in Directive 97/78/EC shall apply,
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 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:

Article 4

Amendments to Directive 88/661/EEC

Directive 88/661/EEC is hereby amended as follows:

1. the following Article shall be inserted:

(a)

it meets the conditions:

‘Article 4a

(i) for approval of semen collection centres or storage

centres set out in Chapter I of Annex A;

Member States shall draw up and keep up to date a list of
bodies as referred to in Article 1(c), first indent, and make it
available to the other Member States and to the public.

14.8.2008

EN

Official Journal of the European Union

L 219/45

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

2. Article 8 shall be replaced by the following:

2. the following Article shall be inserted:

‘Article 7a

Member States shall draw up and keep up to date a list of
bodies as referred to in Article 1(d), first indent, and make it
available to the other Member States and to the public.

‘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:

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

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

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
bodies as referred to in Article 2(b), first indent, which are
officially approved for the purpose of maintaining or estab­
lishing 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:

The

competent authority of

‘2.
each Member State
concerned shall register embryo collection teams and give
a veterinary registration number to each team.

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

(b) it has been officially approved by the

the third country for exports

competent
to the

authority of
Community;

(c)

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

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.

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.’;

Detailed rules for

3.
this
Article may be adopted in accordance with the procedure
referred to in Article 18(2).’;

the uniform application of

L 219/46

EN

Official Journal of the European Union

14.8.2008

3. Article 11 shall be replaced by the following:

‘Article 11

in
The rules laid down in Directive 97/78/EC shall apply,
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 90/426/EEC

In Article 7 of Directive 90/426/EEC, paragraph 1 shall be
replaced by the following:

‘1.
The equidae must be transported, as soon as possible,
from the holding of origin either directly or via an approved
market or marshalling centre as defined as “assembly centre”
in Article 2(2)(o) of Directive 64/432/EEC to the place of
destination in vehicles or containers which have been
regularly cleansed and disinfected with a disinfectant at
intervals to be fixed by the Member State of dispatch. The
vehicles must be designed in such a way that equidae
droppings,
litter or fodder cannot escape from the vehicle
during transportation. Transportation must be effected in
such a way that the health and well-being of the equidae
can be protected effectively.’.

Article 8

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
bodies maintaining or establishing studbooks as referred to in
Article 2(c), first indent, 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.

(a) competitions reserved for equidae registered in a
specific stud book for the purpose of permitting the
improvement of the breed;

(b) regional
equidae;

competitions with a view to selecting

(c) historic or traditional events.

Member States intending to avail
these
possibilities shall make this intention and the justifi­
cations thereof available to the other Member States
and to the public beforehand;

themselves of

— for each competition or type of competition Member
States shall be authorised to reserve, through the bodies
officially approved or recognised for that purpose, a
certain percentage of
the prize money or profits
referred to in paragraph 1(c) for the safeguard, develop­
ment 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 10

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:

All semen collection centres shall be registered, each

‘2.
centre being given a veterinary registration number.

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

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.’;

Article 9

Amendments to Directive 90/428/EEC

2. Article 8 shall be replaced by the following:

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

‘Article 8

‘2.

However,

— the obligations referred to in Article 3 shall not affect the

organisation of:

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:

14.8.2008

EN

Official Journal of the European Union

L 219/47

(a)

it meets the conditions:

1. Article 4 shall be replaced by the following:

(i) for the approval of semen collection centres set out

‘Article 4

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

the third country for exports

competent
to the

authority of
Community;

(c)

it is placed under the supervision of a centre veterinarian;

reference
Each Member State shall designate a national
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).’;

(d) it is subject to inspections by an official veterinarian of

the third country concerned at least twice a year.

2. the following Article shall be inserted:

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.

‘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.

The approval of a semen collection centre must be imme­
diately 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.

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:

Detailed rules for

this
3.
Article may be adopted in accordance with the procedure
referred to in Article 18(2).’;

the uniform application of

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 11

Amendments to Directive 90/539/EEC

‘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
in this
Directive. To this end:

for

(a)

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

(b) they shall monitor the quality of reagents used by
the laboratories approved for the purpose of
carrying out the diagnostic tests provided for in
this Directive;

Directive 90/539/EEC is hereby amended as follows:

(c)

they shall organise periodic comparative tests.’.

L 219/48

EN

Official Journal of the European Union

14.8.2008

Article 12

Amendments to Directive 91/68/EEC

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

Detailed rules for the uniform application of this sub­
paragraph may be adopted in accordance with the
procedure referred to in Article 22.’.

1.

in Article 8a, paragraph 3 shall be replaced by the following:

The competent authority shall

‘3.
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.’;

2.

in Article 8b, the following paragraph 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.

Article 14

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

2.
laboratories
designated in accordance with paragraph 1 are set out in
Annex I.

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

The national laboratories designated in accordance with
liaise with the Community reference

3.
paragraph 1 shall
laboratory referred to in Article 15.’;

Article 13

2.

in Annex I, Section A shall be deleted.

Amendments to Directive 91/496/EEC

In Article 10 of Directive 91/496/EEC, paragraph 4 shall be
replaced by the following:

‘4. (a) The procedure laid down in Article 22 must be followed
for the approval and subsequent updating of the list of
quarantine centres referred to in the first
indent of
paragraph 1. The Commission shall publish the list of
these quarantine centres and any subsequent updates in
the Official Journal of the European Union.

(b) Quarantine centres referred to in the second indent of
paragraph 1 and the first indent of paragraph 2 that
fulfil
the conditions laid down in Annex B shall be
approved by the Member States, each centre being
given an approval number. Each Member State shall
draw up and keep up to date a list of approved quar­
antine centres and their approval numbers and make it
available to the other Member States and to the public.
Quarantine centres shall be subject to the inspection
provided for in Article 19.

Article 15

Amendments to Directive 92/65/EEC

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

1. Article 11 shall be replaced by the following:

‘Article 11

The Member States shall ensure that, without prejudice
1.
to the decisions to be taken in implementation of Articles 21
and 23, only semen, ova and embryos meeting the
conditions laid down in paragraphs 2, 3, 4 and 5 are the
subject of trade.

2.
Semen of the ovine, caprine and equine species must,
without prejudice to any criteria to be complied with for the
entry of equids in stud books for certain specific breeds:

14.8.2008

EN

Official Journal of the European Union

L 219/49

— have been collected, processed and stored with a view to
artificial
insemination in a centre approved from the
health point of view in accordance with Annex D(I),
or, in the case of ovine and caprine animals by way of
in a holding satisfying the
derogation from the above,
requirements of Directive 91/68/EEC,

— have been collected from animals meeting the conditions

laid down in Annex D(II),

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

5.
The animal health requirements and the specimen
health certificates applicable to semen, ova and embryos of
species not mentioned in paragraphs 2 and 3 shall be estab­
lished in accordance with the procedure referred to in
Article 26.

— have been collected, processed, preserved, stored and

transported in accordance with Annex D(III),

Pending the establishment of animal health requirements and
specimen health certificates for trade in such semen, ova and
embryos, national rules shall continue to apply.’;

— have been accompanied during transport

to another
Member State by a health certificate corresponding to a
specimen to be determined in accordance with the
procedure referred to in Article 26.

Ova and embryos of the ovine, caprine, equine and

3.
porcine species must:

— have been removed from donor females meeting the
conditions laid down in Annex D(IV) by a collection
team or have been produced by a production team
approved by the competent authority of the Member
State and satisfying the conditions to be established in
Annex D(I) in accordance with the procedure referred to
in Article 26,

— have been collected, processed and preserved in an
in

transported

stored

and

appropriate
accordance with Annex D(III),

laboratory,

— be accompanied during transport

to another Member
State by
to a
corresponding
specimen to be determined in accordance with the
procedure referred to in Article 26.

a health certificate

Semen used for the insemination of donor females must
comply with the provisions of paragraph 2 in the case of
sheep, goats and equids and with the provisions of Directive
90/429/EEC for swine.

Any additional guarantees may be determined in accordance
with the procedure referred to in Article 26.

The approved centres referred to in the first indent of
4.
paragraph 2 and the approved 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.

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

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.’;

3.

in Article 17, paragraph 2 and 3 shall be replaced by the
following:

‘2.
Only animals, semen, ova and embryos referred to in
Article 1 which satisfy the following requirements may be
imported into the Community:

(a)

they must come from a third country on a list to be
drawn up in accordance with paragraph 3(a);

(b) they must be accompanied by the health certificate corre­
sponding to a specimen to be drawn up in accordance
with the procedure referred to in Article 26, signed by
the competent authority of the exporting country and
certifying that,

(i) the animals

— meet

the additional conditions or offer
the
equivalent guarantees referred to in paragraph
4, and

— come from approved centres, bodies,

institutes
offering guarantees at least equivalent to those
in Annex C;

L 219/50

EN

Official Journal of the European Union

14.8.2008

(ii) semen, ova and embryos come from approved
collection and storage centres or collection and
production teams offering
least
equivalent to those to be established in Annex D(I)
in accordance with the procedure referred to in
Article 26.

guarantees

at

lists of

establishment of

Pending the
third countries,
approved establishments listed in point (b), animal health
requirements and specimen health certificates as referred to
in paragraphs (a) and (b), national rules shall continue to
apply provided they are not more favourable than those
laid down in Chapter II.

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 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.’.

3.

The following shall be established:

Article 16

(a)

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

equivalent

II

(b) in accordance with this point, a list of approved centres
or 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 guar­
antees provided for in Article 11(2) and (3).

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

The approval of centres or teams 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.

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

(c)

referred to in
in accordance with the procedure
Article 26, 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.

Amendments to Directive 92/66/EEC

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

1. Article 14 shall be 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
to in
paragraph 1 and make them available to the other
Member States and to the public.

laboratories or

institutes

referred

for

this
Detailed rules
paragraph may be adopted in accordance with the
procedure referred to in Article 25(2).’;

the uniform application of

2. Annex IV shall be deleted.

14.8.2008

EN

Official Journal of the European Union

L 219/51

Article 17

Article 19

Amendments to Directive 92/119/EEC

Amendments to Directive 2000/75/EC

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

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

1.

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

1. Article 15 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 18

Amendments to Directive 94/28/EC

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

1. Article 3 shall be amended as follows:

(a) paragraph 1 shall be replaced by the following:

A list of bodies in respect of the species and/or
the
this

‘1.
races concerned that
the competent authority of
third country has approved for the purpose of
Directive shall be communicated to the Commission.

The approval of a body 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
information
make them available to the public for
purposes.’;

(b) in paragraph 2, point (a) shall be deleted;

(c) paragraph 3 shall be deleted;

2.

in Article 10, the following paragraph shall be added:

infringement

to the provisions

‘Where any serious
in
in particular in the light of
Article 3(2)(b) so warrants,
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 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

2.
accordance with paragraph 1 are listed in Annex I.

laboratories designated in

3.
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.

in Annex I, Section A shall be deleted.

Article 20

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
the
may authorise the applicant
serological
rabies
to monitor
tests
vaccines.

laboratory to carry out
the effectiveness of

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.

L 219/52

EN

Official Journal of the European Union

14.8.2008

Detailed rules for

this
3.
Article may be adopted in accordance with the procedure
referred to in Article 5(2).’;

the uniform application of

‘(b) a national

laboratory is responsible for coordinating
in each Member

standards and diagnostic methods
State in accordance with Annex IV.

2. the following Article shall be inserted:

‘Article 5a

Applications for approval of laboratories submitted by the
Member States prior to 1 January 2010, in accordance with
Article 3 and Annex II, shall continue to be governed by this
Decision, in its version before 3 September 2008.’;

3. Annexes I and II shall be replaced by the text in the Annex

to this Directive.

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’;

Article 21

Amendments to Directive 2001/89/EC

(b) point 1 shall be deleted.

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 22

Amendments to Directive 2002/60/EC

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

Article 23

Amendments to Directive 2005/94/EC

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

‘2. Member States shall designate a national
reference
thereof, and any
laboratory and shall make the details
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 24

Transposition

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 1 January 2010 at
latest. They shall
forthwith communicate to the Commission the text of those
provisions.

the

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.

1.

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

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.

14.8.2008

EN

Official Journal of the European Union

L 219/53

Article 25

Entry into force
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the
European Union.

This Directive is addressed to the Member States.

Article 26

Addressees

Done at Brussels, 15 July 2008.

For the Council
The President

M. BARNIER

L 219/54

EN

Official Journal of the European Union

14.8.2008

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

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,
vaccinated against rabies,

improvement and standardisation of methods of serological titration on carnivores

— 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.’