Proposal for a Council Directive amending Directive 88/407/EEC laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the bovine species
Date: 2002-09-25
Institutions: European Commission
Subjects: artificial reproduction, cattle, health certificate, health control, import, intra-EU trade, storage, veterinary inspection

C 20 E/246

EN

Official Journal of the European Communities

28.1.2003

Proposal for a Council Directive amending Directive 88/407/EEC laying down the animal health
requirements applicable to intra-Community trade in and imports of semen of domestic animals of
the bovine species

(2003/C 20 E/22)

COM(2002) 527 final — 2002/0229(CNS)

(Submitted by the Commission on 25 September 2002)

EXPLANATORY MEMORANDUM

Council Directive 88/407/EEC lays down the animal health requirements applicable to intra-Community
trade in, and imports of semen of domestic animals of the bovine species.

This Directive needs to be amended.

The purpose of this proposal is:

— to allow the storage of semen at other premises than the Artificial Insemination centre where semen

was collected,

— to amend, in the light of the new scientific data available and the new provisions laid down in the
Office International des Epizooties (OIE), the animal health conditions applicable to entry of bulls into
AI centres,
in particular concerning infectious bovine rhinothracheitis (IBR/IPV) and bovine viral
diarrhoea (BVD/MD),

— to simplify, at the Community level, the procedure for the agreement and listing of AI centres in third
countries. These lists are frequently modified on the basis of the information sent by the competent
authorities of third countries (address, name, new establishment, etc.),

— to allow the Commission to amend, following the comitology procedure, the annexes of Directive
88/407/EEC as they cover technical points relating to approval of centres and conditions of admission
of bulls onto centres.

The proposal has no financial impact on Community budget.

THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament,

Having regard to the opinion of the Economic and Social
Committee,

Having regard to the opinion of the Committee of the Regions,

Whereas:

(1) Directive 88/407/EEC (1)

lays down the animal health
requirements applicable to intra-Community trade in and
imports of semen of domestic animals of
the bovine
species.

(1) OJ L 194, 22.7.1988, p. 10.

(2) In the light of

to amend

the new scientific data available,

is
conditions
necessary
applying to entry of bulls into artificial
insemination
centres, in particular concerning infectious bovine rhinot-
racheitis/infectious pustular vulvovaginitis (IBR/IPV) and
bovine viral diarrhoea/mucosal diarrhoea (BVD/MD).

animal health

the

it

(3) The procedure to establish the list of semen collection
centres in third countries from which the importation of
semen is authorised should be simplified.

(4) The same requirements for storage should apply to all
establishments whether or not they are associated with a
production unit.

(5) The necessary measures for the implementation of

this
Directive are of general scope within the meaning of
Article 2 of Council Decision 1999/468 of 28 June 1999
laying down the procedures for the exercise of implemen-
tation powers conferred on the Commission, they should
be adopted by use of the regulatory procedure provided for
in Article 5 of that Decision,

28.1.2003

EN

Official Journal of the European Communities

C 20 E/247

HAS ADOPTED THIS DIRECTIVE:

6. Article 17 shall be replaced by:

Article 1

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

1. Article 2(b) is replaced by the following:

‘(b)

collection

centre” means

“Semen
officially
approved and supervised establishment situated in
the territory of a Member State or third country, in
which semen is produced and stored for use in
artificial insemination;

an

“Semen storage centre” means an officially approved
and supervised establishment situated in the territory
of a Member State or third country in which semen is
stored for use in artificial insemination.’

2. Article 3(a) is replaced by the following:

‘(a)

it must have been collected, processed and/or stored
in a centre or centres approved in accordance with
Article 5(1).’

3. Articles 4(1) and 4(2) are deleted.

‘The Annexes
to this Directive shall be amended in
accordance with the procedure set out in Article 18, in
particular to adapt them to advances in technology.’

7. Article 18 is replaced by:

‘Article 18

1. Where the procedure referred to in this Article is to
be used the Commission shall be assisted by the Standing
Committee on the Food Chain and Animal Health set up
by Regulation 2002/178/EC shall act in accordance with
the procedure
laid down in Article 5 of Decision
1999/468/EC and in compliance with Article 7(3) thereof.

The period referred to in Article 5(6) of Decision

2.
1999/468/EC shall be three months.’

8. Article 19 is deleted.

9. In Articles 8, 9, 11 and 16, the words ‘the procedure laid
down in article 19’ are replaced by the words ‘the
procedure referred to in article 18’.

4. In Articles 5, 9(2) and 9(3), the words ‘semen collection
centre(s)’ are replaced by the words ‘semen collection or
storage centre(s)’.

10. Annexes A, B, C and D to Directive 88/407/EEC are
replaced by the text in the Annex to this Directive.

5. Article 9(1) is replaced by the following:

Article 2

The Commission shall establish the lists of semen
‘1.
collection and storage centres from which the Member
States may authorise the importation of semen originating
in third countries.

The Commission shall inform the Member States of the
modifications proposed by the third country concerned to
the lists of centres.

The Member States shall have ten working days,
receipt of
written comments to the Commission.

the proposed modifications,

from
to send any

Where no comments are received from Member States
within the time limit laid down in the third sub-paragraph,
the modifications to the lists shall be considered to have
been accepted by the Member States and imports shall be
authorised from such centres when the Commission
notifies the competent authorities of the Member states
and third country concerned that the modifications are
published on the website of the Commission.

Where written comments are made by at
least one
Member State, the Commission shall inform the Member
States and include the point on the next meeting of the
Standing Committee on the Food Chain and Animal
Health for decision in accordance with the procedure
referred to in Article 18.’

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by at
forthwith inform the
Commission thereof.

the latest. They shall

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. The
Member States shall adopt
the methods of making such
reference.

2. Member States shall inform the Commission of the text
of the essential provisions of national law, which they adopt in
the area governed by this Directive.

Article 3

This Directive shall enter into force on the . . . following that of
its publication in the Official Journal of the European Communities.
Intra-community trade in and imports of semen certified
according to the provisions and the model of certificate
formerly in force shall be accepted for a period of six
months after the date of publication of this Directive.

Article 4

This Directive is addressed to the Member States.

C 20 E/248

EN

Official Journal of the European Communities

28.1.2003

ANNEX

‘Annex A

CHAPTER I

CONDITIONS FOR THE APPROVAL OF CENTRES

1. Semen collection centres must:

(a) be placed under the permanent supervision of a centre veterinarian;

(b) have a least:

(i) animal housing including isolation facilities;

(ii) semen collection facilities including a separate room for the cleaning and disinfection or sterilisation of

equipment;

(iii) a semen processing room which need not necessarily be on the same site;

(iv) a semen storage room which need not necessarily be on the same site;

(c) be so constructed or isolated that contact with livestock outside is prevented;

(d) be so constructed that the animal housing and the semen collecting, processing and storage facilities can be

readily cleaned and disinfected;

(e) have isolation accommodation which shall have no direct communication with the normal animal accom-

modation;

(f) be so designed that the animal accommodation is physically separated from the semen processing room and both

are separated from the semen storage room.

2. Semen storage centres must:

(a) be placed under the permanent supervision of a centre veterinarian;

(b) be so constructed or isolated that contact with livestock outside is prevented;

(c) be so constructed that the storage facilities can be readily cleaned and disinfected;

CHAPTER II

CONDITIONS RELATING TO THE SUPERVISION OF CENTRES

1. The collection centres must:

(a) be so supervised that they contain only animals of the species whose semen is to be collected. Other domestic
animals which are strictly necessary for the normal operation of the collection centre may nonetheless also be
admitted, provided that they present no risk of infection to those species whose semen is to be collected, and that
they fulfil the conditions laid down by the centre veterinarian;

(b) be so supervised that a record is kept of all bovine animals at the centre, giving details of the breed, date of birth
and identification of each of the animals, and also a record of all checks for diseases and all vaccinations carried
out for each animal;

(c) be regularly inspected by an official veterinarian, at least twice a year, in the context of standing checks on the

conditions of approval and supervision;

(d) be so supervised that the entry of unauthorised persons is prevented. Furthermore, authorised visitors must be

required to comply with the conditions laid down by the centre veterinarian;

(e) employ technically competent staff suitably trained in disinfection procedures and hygiene techniques relevant to

the control of the spread of disease;

28.1.2003

EN

Official Journal of the European Communities

C 20 E/249

(f) be so supervised that:

(i) only semen collected at an approved centre is processed and stored in approved centres, without coming
into contact with any other consignment of semen. However, semen not collected in an approved centre
may be processed in approved collection centres provided that:

— such semen is produced from bovine animals which fulfil the conditions laid down in Chapter I. 1(d)(i),

(ii), (iii) and (v) of Annex B,

— processing is carried out with separate equipment or at a different time from semen intended for

intra-Community trade, the equipment in the latter case being cleaned and sterilised after use,

— such semen may not be the subject of intra-Community trade and cannot at any time come into

contact with, or be stored with, semen intended for intra-Community trade,

— such semen is identifiable by a marking different from that provided for in point (vii).

Also deep-frozen embryos may be stored in approved centres provided that:

— such storage is authorised by the competent authority,

— the embryos meet the requirements of Council Directive 89/556/EEC of 25 September 1989 on animal
health conditions governing intra-Community trade in and importation from third countries of embryos
of domestic animals of the bovine species,

— the embryos are stored in separate storage flasks in the premises for storing approved semen;

(ii) collection, processing and storage of semen takes place only on the premises set aside for the purpose and

under the strictest conditions of hygiene;

(iii) all implements(?) which come into contact with the semen or the donor animal during collection and

processing are properly disinfected or sterilised prior to use;

(iv) products of animal origin used in the processing of semen — including additives or a diluent — are
obtained from sources which present no animal health risk or are so treated prior to use that such risk is
prevented;

(v) storage flasks and transport flasks are either properly disinfected or sterilised before the commencement of

each filling operation, except for disposable containers;

(vi) the cryogenic agent used has not been previously used for other products of animal origin;

(vii) each individual dose of semen is clearly marked in such a way that the date of collection of the semen, the
breed and identification of the donor animal, and the approval number of the centre, can be readily
established; each Member State shall communicate to the Commission and other Member States the
characteristics and form of the marking implemented on its territory;

(viii) the storage unit must comply with specific conditions relating to the supervision of semen storage centres

provided in the following paragraph.

2. The storage centres must:

(a) be so supervised that a record is kept of all movement of semen (in and out the centre) and of the status of the
donor bulls whose semen is stored there, and which must comply with the requirements of Directive
88/407/EEC;

(b) be regularly inspected by an official veterinarian, at least twice a year, in the context of the standing checks on

the conditions of approval and supervision;

(c) be so supervised that the entry of unauthorised persons is prevented. Furthermore, authorised visitors must be

required to comply with the conditions laid down by the centre veterinarian;

C 20 E/250

EN

Official Journal of the European Communities

28.1.2003

(d) employ technically competent staff suitably trained in disinfection procedures and hygiene techniques relevant to

the control of the spread of disease;

(e) be so supervised that:

(i) only semen collected at collection centres approved in accordance with Directive 88/407/EEC is stored in

approved storage centres, without coming into contact with any other semen.

Also deep-frozen embryos may be stored in approved centres provided that:

— such storage is authorised by the competent authority,

— the embryos meet the requirements of Council Directive 89/556/EEC of 25 September 1989 on animal
health conditions governing intra-Community trade in and importation from third countries of embryos
of domestic animals of the bovine species,

— the embryos are stored in separate storage flasks in the premises for storing approved semen;

(ii) storage of semen takes place only on the premises set aside for the purpose and under the strictest conditions

of hygiene;

(iii) all implements which come into contact with the semen are properly disinfected or sterilised prior to use;

(iv) storage flasks and transport flasks are either properly disinfected or sterilised before the commencement of

each filling operation, except for disposable containers;

(v) the cryogenic agent used has not been previously used for other products of animal origin;

(vi) each individual dose of semen is clearly marked in such a way that the date of collection of the semen, the
breed and identification of the donor animal, and the approval number of the centre, can be readily
established; each Member State shall communicate to the Commission and other Member States the charac-
teristics and form of the marking implemented on its territory.

Annex B

CHAPTER I

CONDITIONS APPLYING TO THE MOVEMENT OF ANIMALS INTO APPROVED SEMEN COLLECTION
CENTRES

1. For all bovine animals admitted to a semen collection centre the following requirements apply:

(a) they have been subjected to a period of quarantine of at least 28 days in accommodation specifically approved
for the purpose by the competent authority of the Member State, and where only other cloven-hoofed animals
having at least the same health status are present;

(b) prior to their stay in the quarantine accommodation described in (a), they have belonged to a herd which is
officially tuberculosis free and officially brucellosis free in accordance with Directive 64/432/EEC. The animals
shall not previously have been kept in one herds of a lower status;

(c) they have come from a herd officially free of enzootic bovine leucosis as defined in Directive 64/432/EEC, or
have been produced by dams which have been subjected, with negative results, to a test carried out in accordance
with Annex D (Chapter II) of Directive 64/432/EEC, after removal of the animals from their dam. In the case of
animals derived by embryo transfer, “dam” means the recipient of the embryo.

If this requirement cannot be fulfilled, the semen shall not be the subject of trade until the donor has reached the
age of two years and has been tested in accordance with Chapter II. 1(c) with a negative result;

(d) within the 28 days preceding the period of quarantine specified in (a), they have been subjected to the following

tests with negative results in each case, except for BVD/MD antibody test mentioned in (v):

(i) for bovine tuberculosis, an intradermal tuberculin test carried out in accordance with the procedure laid

down in Annex B to Directive 64/432/EEC;

(ii) for bovine brucellosis, a serological test carried out in accordance with the procedure described in Annex C

to Directive 64/432/EEC;

28.1.2003

EN

Official Journal of the European Communities

C 20 E/251

(iii) for enzootic bovine leukosis, a serological test carried out in accordance with the procedure laid down in

Annex D (Chapter II) to Directive 64/432/EEC;

(iv) for IBR/IPV, a serological test (whole virus) on a blood sample if the animals don't come from an IBR/IPV

free herd as defined in Article 2.3.5.3 of the International Animal Health Code;

(v) for BVD/MD,

— a virus isolation test or a test for virus antigen, and

— a serological test to determine the presence or absence of antibodies.

The competent authority may give authorisation for the tests referred to in (d) to be carried out on samples
collected in the quarantine accommodation, provided that the results are known before the commencement of
the quarantine period laid down in (a);

(e) during the quarantine period specified in (a), they have been subjected after at least 21 days of quarantine to the
following tests with negative results, except in the case of for BVD/MD antibody serological testing (see (iii)
below):

(i) for bovine brucellosis, a serological test carried out in accordance with the procedure described in Annex C

to Directive 64/432/EEC;

(ii) for IBR/IPV, a serological test (whole virus) on a blood sample;

if any animals test positive, these animals shall be removed immediately from the quarantine station and the
other animals of the same group shall remain in quarantine and be retested, with negative results, not less
than 21 days after removal of the positive animal(s);

(iii) for BVD/MD,

— a virus isolation test or a test for virus antigen, and

— a serological test to determine the presence or absence of antibodies.

Only if no sero-conversion occurs in the animals, which tested seronegative before entry into the quarantine
station, may any animal (seronegative or seropositive) be allowed entry to the semen collection facilities.

If sero-conversion occurs, all the animals that remain seronegative shall be kept in quarantine over a
prolonged time, until there is no more sero-conversion in the group for a period of three weeks. Sero-
logically positive animals may be allowed entry into the semen collection facilities;

(iv) for campylobacter fetus subsp venerealis:

— in the case of animals less than six months old or kept since that age in a single sex group prior to

quarantine, a single test on a sample of artificial vagina washings or preputial specimen;

— in the case of animals aged six months or older that could have had contact with females prior to
quarantine, a test three times at weekly intervals on a sample of artificial vagina washings or preputial
specimen;

(v) for trichomonas foetus:

— in the case of animals less than six months old or kept since that age in a single sex group prior to

quarantine, a test once on a sample of preputial specimen;

— in the case of animals aged six months or older that could have had contact with females prior to

quarantine, a test three times at weekly intervals on a sample of preputial specimen;

if any of the above tests is positive, the animal must be removed forthwith from the isolation accommodation. In
the case of group isolation, the competent authority must take all necessary measures to re-establish the eligibility
of the remaining animals for entry into the collection centre in accordance with the Annex;

C 20 E/252

EN

Official Journal of the European Communities

28.1.2003

(f) prior to the initial dispatch of semen from BVD/MD serologically positive bulls, a semen sample from each
animal shall be subjected to a virus isolation or virus antigen ELISA test for BVD/MD. In the event of a positive
result, the bull shall be removed from the centre and all of its semen destroyed.

2. All tests must be carried out in a laboratory approved by the Member State.

3. Animals may only be admitted to the semen collection centre with the express permission of the centre veterinarian.

All movements, both in and out, must be recorded.

4. No animal admitted to the semen collection centre may show any clinical sign of disease on the day of admission. All
animals must, without prejudice to paragraph 5, have come from isolation accommodation as referred to in
paragraph 1(a), which on the day of consignment, officially fulfils the following conditions:

(a)

is situated in the centre of an area of 10 kilometres radius in which there has been no case of foot-and-mouth
disease for at least 30 days;

(b) has for at least three months been free from foot-and-mouth disease and brucellosis;

(c) has for at least 30 days been free from those bovine diseases which are compulsorily notifiable in accordance

with Annex E to Directive 64/432/EEC.

5. Provided that the conditions laid down in paragraph 4 are satisfied and the routine tests referred to in Chapter II
have been carried out during the previous 12 months, animals may be transferred from one approved semen
collection centre to another of equal health status, without isolation or testing if transfer is direct. The animal in
question must not come into direct or indirect contact with cloven-hoofed animals of a lower health status and the
means of transport used must have been disinfected before use. If the movement from one semen collection centre to
another takes place between Member States it must take place in accordance with Directive 64/432/EEC.

CHAPTER II

ROUTINE TESTS WHICH MUST BE APPLIED TO ALL BOVINE ANIMALS IN AN APPROVED SEMEN
COLLECTION CENTRE

1. All bovine animals kept at an approved semen collection centre must be subjected at least once a year to the

following tests, with negative results:

(a)

for bovine tuberculosis, an intradermal tuberculin test, carried out in accordance with the procedure laid down in
Annex B to Directive 64/432/EEC;

(b) for bovine brucellosis, a serological test carried out in accordance with the procedure described in Annex C to

Directive 64/432/EEC;

(c)

for enzootic bovine leucosis, a serological test carried out in accordance with the procedure described in Annex
D (Chapter II) to Directive 64/432/EEC;

(d) for IBR/IPV, a serological test (whole virus) on a blood sample;

(e)

for BVD/MD, a serological antibody which is applied only to seronegative animals.

Should an animal become serologically positive, every ejaculate of that animal collected since the last negative
test shall be either discarded or tested for virus with negative results;

(f)

for campylobacter fetus subsp venerealis, a test on a sample of preputial specimen. Only bulls on semen production
or having contact with bulls on semen production need to be tested. Bulls returning to collection after a lay off of
more than six months shall be tested not more than 30 days prior to resuming production;

(g) for trichomonas foetus, a test on a sample of preputial specimen. Only bulls on semen production or having
contact with bulls on semen production need to be tested. Bulls returning to collection after a lay off of more
than six months shall be tested not more than 30 days prior to resuming production.

2. All tests must be carried out in a laboratory approved by the Member State.

28.1.2003

EN

Official Journal of the European Communities

C 20 E/253

3. If any of the above tests is positive, the animal must be isolated and the semen collected from it since the last
negative test may not be the subject of intra-Community trade with the exception, for BVD/MD, of semen from every
ejaculate which has been tested BVD/MD virus negative.

Semen collected from all other animals at the centre since the date when the positive test was carried out shall be
held in separate storage and may not be the subject of intra-Community trade until the health status of the centre has
been restored.

CONDITIONS WHICH SEMEN MUST SATISFY FOR THE PURPOSES OF INTRA-COMMUNITY TRADE

Annex C

1. Semen must be obtained from animals which:

(a) show no clinical signs of disease on the day the semen is collected;

(b)

(i) have not been vaccinated against foot-and-mouth disease during the 12 months prior to collection, or

(ii) have been vaccinated against foot-and-mouth disease during the 12 months prior to collection, in which case
5 % (with a minimum of five straws) of each collection shall be submitted to virus isolation test for
foot-and-mouth disease with negative results;

(c) have not been vaccinated against foot-and-mouth disease within 30 days immediately prior to collection;

(d) have been kept at an approved semen collection centre for a continuous period of at least 30 days immediately

prior to the collection of the semen in the case of collections of fresh semen;

(e) are not allowed to serve naturally;

(f) are kept in semen collection centres which have been free from foot-and-mouth disease for at least three months
prior to collection of the semen and 30 days after collection or, in the case of fresh semen, until the date of
dispatch, and which are situated in the centre of an area of 10 kilometres radius in which for at least 30 days
there has been no case of foot-and-mouth disease;

(g) have been kept in semen collection centres which, during the period commencing 30 days prior to collection and
ending 30 days after collection of the semen or, in the case of fresh semen, until the date of dispatch, have been
free from those bovine diseases which are compulsorily notifiable in accordance with Annex E(I) to Directive
64/432/EEC.

2. Antibiotics as listed below must be added to produce these concentrations in the final diluted semen:

not less than:

— 500 µg streptomycin per ml final dilution,

— 500 IU penicillin per ml final dilution,

— 150 µg lincomycin per ml final dilution,

— 300 µg spectinomycin per ml final dilution.

An alternative combination of antibiotics with an equivalent effect against campylobacters, leptospires and myco-
plasmas may be used.

Immediately after their addition the diluted semen must be kept at a temperature of at least 5 °C for a period of not
less than 45 minutes.

3. Semen for intra-Community trade must:

(a) be stored in approved conditions for a minimum period of 30 days prior to dispatch. This requirement shall not

apply to fresh semen;

(b) be transported to the Member State of destination in flasks which have been cleaned and disinfected or sterilised
before use and which have been sealed and numbered prior to dispatch from the approved storage facilities.

C 20 E/254

EN

Official Journal of the European Communities

28.1.2003

Annex D