1988L0407 — EN — 11.06.2003 — 006.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE
of14June1988
layingdowntheanimalhealthrequirementsapplicabletointra-Communitytradeinandimports
of►M3 ◄semenofdomesticanimalsofthebovinespecies
(88/407/EEC)
(OJ L 194, 22.7.1988, p. 10)
Amended by:
Official Journal
No page date
►M1Council Directive 90/120/EEC of 5 March 1990 L 71 37 17.3.1990
►M2Council Directive 90/425/EEC of 26 June 1990 L 224 29 18.8.1990
►M3Council Directive 93/60/EEC of 30 June 1993 L 186 28 28.7.1993
►M4Council Regulation (EC) No 806/2003 of 14 April 2003 L 122 1 16.5.2003
►M5Council Directive 2003/43/EC of 26 May 2003 L 143 23 11.6.2003
Amended by:
►A1Act of Accession of Austria, Sweden and Finland C241 21 29.8.1994
(adapted by Council Decision 95/1/EC, Euratom, ECSC) L 1 1 1.1.1995
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COUNCILDIRECTIVE
of14June1988
laying down the animal health requirements applicable to intra-
Community trade in and imports of ►M3 ◄semen
ofdomesticanimalsofthebovinespecies
(88/407/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social
Committee (3),
Whereas provisions relating to animal health problems in intra-
Community trade in bovine animals and swine appear in Directive 64/432/EEC (
4), as last amended by Regulation (EEC) No 3768/85 (5);
whereas inaddition , Directive 72/462/EEC (6), as last amended by
Regulation (EEC) No 3768/85 contains provisions relating to veterinary
inspection problems upon importation of bovine animals and swinefrom third countries;
Whereas the abovementioned provisions have ensured, with regard to
intra-Community trade and imports into the Community of bovine
animals and swine from third countries, that the country of provenance
guarantees that animal health criteria have been fulfilled so that the riskof animal disease spreading has been virtually eliminated; whereasthere is nevertheless a certain risk of the spread of such disease in thecase of trade insemen ;
Whereas in the context of the Community policy of harmonizing
national animal health provisions governing intra-Community trade in
animals and animal products, it is now necessary to create a harmo-nized system for intra-Community trade and imports into theCommunity of semen of bovine animals;
Whereas, in the context of intra-Community trade in semen, the
Member State where the semenis collected should be un der anobliga-
tion to ensure that such semen has been collected and processed atapproved and supervised semen collection centres, has been obtainedfrom animals whose health status is such as to ensure that the risk ofspread of animal disease is eliminated, has been collected, processed,
stored and transported in accordance with rules which preserve its
health status and is accompanied during transport to the country ofdestination by an animal health certificate in order to ensure that thisobligationhas beenfulfilled;
Whereas the difference in the policies pursued within the Community
with regard to vaccination against certain diseases justifies the mainte-
nance of derogations, limited in time, authorizing the requirement by
the Member States, inrespect of certaindiseases, of addition al protec-tionagain st those diseases;
Whereas for imports of semen into the Community from third countries
a list of third countries should be drawn up taking into account animal
health criteria; whereas without prejudice to such a list the Member
States should authorize importationof semenon ly from semencollec-tion centres which reach certain standards and which are officially1988L0407 — EN — 11.06.2003 — 006.001 — 2
(1) OJ No C 267, 6. 10. 1983, p. 5.
(2) OJ No C 342, 19. 12. 1983, p. 11.
(3) OJ No C 140, 28. 5. 1984, p. 6.
(4) OJ No 121, 29. 7. 1964, p. 1977/64.
(5) OJ No L 362, 31. 12. 1985, p. 8.
(6) OJ No L 302, 31. 12. 1972, p. 28.
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supervised; whereas, inaddition , inrespect of coun tries onthat list,
specific animal health conditions should be laid down according tocircumstances; whereas, in order to verify compliance with these stan-
dards, on-the-spot checks may be carried out;
Whereas a procedure should be provided for the purpose of settling any
disputes which arise betweenMember States as to whether approval ofa collectioncen tre is justified;
Whereas the Member States may refuse a consignment of semen where
it has been established that it does not comply with the provisions ofthis Directive; whereas it must be possible to returnsuch semenif thisis not contrary to considerations of animal health and if the consignoror his representative so requests; whereas the consignor or his represen-
tative should be allowed to know the reasons for a prohibition or
restriction and to obtain the opinion of an expert;
Whereas in order to prevent the transmission of certain contagious
diseases, import controls should be carried out when a consignment of
semenarrives onthe territory of the Commun ity, except inthe case of
external transit;
Whereas after such control, in the case of internal transit, the measures
to be takenby Member States must be defin ed;
Whereas a Member State should be permitted to take emergency
measures in the event of an outbreak of a contagious disease in anotherMember State or in a third country; whereas the dangers associatedwith such diseases and the protective measures they necessitate shouldbe assessed inthe same way throughout the Commun ity; whereas to
that end, an emergency Community procedure under which the neces-
sary measures must be taken should be instituted within the StandingVeterinary Committee;
Whereas the Commission should be entrusted with taking certain
measures for implementing this Directive; whereas to that end, a proce-
dure should be established for close and effective cooperation between
the Commission and the Member States within the Standing VeterinaryCommittee;
Whereas this Directive does not affect trade in semen produced before
the date onwhich the Member States must comply with it.
HAS ADOPTED THIS DIRECTIVE:
CHAPTER I
General provisions
Article 1
This Directive lays down the animal health conditions applicable to
intra-Community trade in and imports from third countries of
►M3 ◄semen of domestic animals of the bovine
species.
This Directive shall not affect Community and/or national zootechnical
provisions governing the organisation of artificial insemination ingeneral and the distribution of semen in particular.
Article 2
For the purposes of this Directive, the definitions contained in Article 2
of Directive 64/432/EEC and Article 2 of Directive 72/462/EEC shall
apply as necessary.
Moreover:
(a) ‘semen’ means the prepared or diluted ejaculate of a domestic
animal of the bovine species;1988L0407 — EN — 11.06.2003 — 006.001 — 3
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(b) — ‘semen collection centre’ means an officially approved and offi-
cially supervised establishment situated in the territory of aMember State or third country, in which semen is produced
for use in artificial insemination;
— ‘semen storage centre’ means an officially approved and offi-
cially supervised establishment situated in the territory of a
Member State or third country in which semen is stored foruse in artificial insemination;
(c) ‘official veterinarian’ means the veterinarian designated by the
competent central authority of a Member State or a third country;
(d) ‘centre veterinarian’ means the veterinarian responsible for day-to-
day compliance in the centre with the requirements laid down in
this Directive;
(e) ‘consignment’ means a quantity of semen covered by a single certi-
ficate;
(f) ‘country of collection’ means the Member State or third country in
which semen is collected and from which it is sent to a MemberState;
(g) ‘approved laboratory’ means a laboratory situated in the territory of
a Member State or third country designated by the competent veter-
inary authority to carry out the tests laid down in this Directive;
(h) ‘collection’ means a quantity of semen taken from a donor at any
time.
CHAPTER II
Intra-Communitytrade
Article 3
Each Member State shall ensure that only semen meeting the following
general conditions is sent from its territory to the territory of anotherMember State;
(a) it must have been collected and processed and/or stored if need be
in a collection or storage centre or centres approved for the purposein accordance with Article 5(1), with a view to artificial insemina-
tion and for the purposes of intra-Community trade;
(b) it must have been collected from domestic animals of the bovine
species whose health status complies with Annex B;
(c) it must have been collected, processed, stored and transported in
accordance with Annexes A and C;
(d) it must be accompanied, during transport to the country of destina-
tion, by an animal health certificate complying with Article 6 (1).
Article 4
3. Member States may not oppose the admission of semen from
bulls vaccinated against foot-and-mouth disease. However, where thesemen was obtained from a bull which had been vaccinated against
foot-and-mouth disease during the 12 month period prior to collection,
5 % of the semenfrom each collection(with a min imum of fivestraws) intended for sending to another Member States shall besubjected, ina laboratory inthe Member State of destin ationor inalaboratory designated by it, to a virus isolation test for foot-and-mouthdisease, with negative results.1988L0407 — EN — 11.06.2003 — 006.001 — 4
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Article 5
1. The Member State onwhose territory the ►M5semencollection
or storage centre ◄is situated shall ensure that the approval provided
for in Article 3 (a) is granted only where the provisions of Annex A are
observed and where the ►M5semencollectionor storage cen tre ◄is
able to satisfy the other provisions of this Directive.
The Member State shall also ensure that the official veterinarian super-
vises the observance of those provisions and shall withdraw approvalwhen one or more of the provisions is no longer observed.
2. All approved ►
M5semencollectionor storage cen tres ◄shall
be registered, each centre being given a veterinary registration number.Each Member State shall send a list of ►
M5semencollectionor
storage centres ◄and their veterinary registration numbers to the
other Member States and to the Commission and shall notify them ofany withdrawal of approval.
The general rules for applying this Article shall be adopted in accor-
dance with ►M5the procedure referred to inArticle 18(2) ◄.
Article 6
1. Member States shall make the admission of semen conditional
uponsubmissionof anan imal health certificate drawnup by anofficial
veterinarian of the Member State of collection in accordance withAnnex D.
This certificate must:
(a) be drawn up in at least one of the official languages of the Member
State of collection and one of those of the Member State of desti-nation;
(b) accompany the consignment to its destination in its original form;
(c) be drawnup ona sin gle sheet of paper;
(d) be made out to a single consignee.
2. (a) The Member State of destination may prohibit the admission of
consignments if a documentary check reveals that Article 3 has
not been observed.
(b) The Member State of destination may take the necessary
measures, including storage in quarantine, in order to obtaindefinite proof in cases where semen is suspected of being
infected or contaminated by pathogenic organisms.
(c) Decisions taken under (a) or (b) must, at the request of the
consignor or his representative, authorize the return of thesemen, provided this is not contrary to considerations of animalhealth.
3. If the admissionof semenhas beenprohibited onan y of the
grounds set out in paragraph 2 (a) and (b) and the Member State of
collection does not within 30 days authorize the return of the semen,the competent veterinary authority of the Member State of destinationmay order it to be destroyed.
4. The decisions taken by the competent veterinary authority under
paragraphs 2 and 3 must be communicated to the consignor or hisrepresentative, together with the reasons therefor.1988L0407 — EN — 11.06.2003 — 006.001 — 5
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CHAPTER III
Importsfromthirdcountries
Article 8
1. A Member State may authorize importationof semenon ly from
those third countries which appear on a list drawn up in accordancewith►
M5the procedure referred to inArticle 18(2) ◄. That list
may be supplemented or amended in accordance with ►M5the proce-
dure referred to inArticle 18(2) ◄.
2. In deciding whether a third country may appear on the list
referred to inparagraph 1, particular accoun t shall be takenof:
(a) the state of health of the livestock, other domestic animals and
wildlife in the third country, with particular reference to exotic
animal diseases, and of the environmental health situation in that
country, which might endanger animal health in the MemberStates;
(b) the regularity and rapidity of the information supplied by the third
country concerning the existence of contagious animal diseases inits territory, in particular those diseases mentioned in lists A and
B of the International Office of Epizootic Diseases;
(c) that country's rules on animal disease prevention and control;
(d) the structure of the veterinary services in the country and their
powers;
(e) the organization and implementation of measures to prevent and
control contagious animal diseases; and
(f) the guarantees which the third country can give with regard to
compliance with this Directive.
3. The list referred to in paragraph 1 and all amendments thereto
shall be published inthe Official Journal of the European Commu-
nities.
Article 9
1. The lists of semen collection and storage centres from which
Member States shall authorise the importation of semen originating inthird countries shall be prepared and updated in accordance with thisArticle.
An establishment may be placed on such a list only if the competent
authority of the third country of origin guarantees that the conditionsreferred to inparagraphs 2 an d 3(b) to (e) are met.
The competent authorities of the third countries appearing on lists
drawn up and updated in accordance with Article 8 shall guaranteethat lists of semen collection and storage centres from which the semen
may be dispatched to the Community are drawn up, kept up-to-date
and communicated to the Commission.
The Commission shall provide the contact points designated by
Member States with regular notifications concerning new or updated
lists that it has received from the competent authorities of the thirdcountries concerned in accordance with subparagraph 3.
If no Member State objects to the new or updated list within 20
working days of the Commission's notification, imports shall beauthorised from establishments appearing on the list 10 working daysafter the day onwhich the Commissionmakes it available to thepublic.
Where written comments are made by at least one Member State or
whenever it considers that amendments to a list are necessary in thelight of relevant information such as Community inspection reports or1988L0407 — EN — 11.06.2003 — 006.001 — 6
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the results of the controls carried out under Article 12, the Commission
shall inform all Member States and include the matter on the agendafor the relevant sector at the next meeting of the Standing Committee
on the Food Chain and Animal Health for decision in accordance with
the procedure referred to inArticle 18(2).
The Commission shall arrange for up-to-date versions of all lists to be
made available to the public.
2. Indecidin g whether a ►
M5semencollectionor storage
centre◄ina third coun try may appear onthe list referred to inpara-
graph 1, particular account shall be taken of the veterinary supervisionof semenproductionsystems inthe third coun try, the powers of theveterinary services and the supervision to which ►
M5semencollec-
tionor storage cen tres ◄are subject.
3. A►M5semencollectionor storage cen tre ◄may appear on
the list provided for inparagraph 1 on ly if:
(a) it is situated in one of the countries on the list referred to in Article
8 (1);
(b) it fulfils the requirements of Chapters I and II of Annex A;
(c) it has beenofficially approved for exports to the Commun ity by the
veterinary services of the third country concerned;
(d) it is under the supervision of a centre veterinarian of the third
country concerned; and
(e) it is subject to regular inspection by an official veterinarian of the
third country concerned at least twice a year.
Article 10
1. Semenmust come from an imals which, immediately prior to
collection of their semen, have remained for at least six months in theterritory of a third country on the list drawn up in accordance withArticle 8 (1).
2. Without prejudice to Article 8 (1) and paragraph 1 of this Article,
the Member States shall not authorize the importation of semen from athird country on the list unless the semen complies with the animal
health requirements adopted, in accordance with ►
M5the procedure
referred to inArticle 18(2) ◄, for imports of semenfrom that coun try.
In adopting the requirements referred to in the preceding subparagraph,
consideration shall be given to:
(a) the health situation in the area surrounding the semen collection
centre, with particular reference to the diseases appearing on listA of the International Office of Epizootic Diseases;
(b) the state of health of the herd inthe semencollectioncen tre,
including testing requirements;
(c) the state of health of the donor animal and testing requirements;
(d) testing requirements in relation to semen.
3. The reference basis for fixing animal health conditions in accor-
dance with paragraph 2 for bovine tuberculosis and brucellosis shall bethe standards laid down in Annex A to Directive 64/432/EEC. It maybe decided, inaccordan ce with ►
M5the procedure referred to in
Article 18(2) ◄, on a case-by-case basis, to waive these conditions
where the third country concerned provides similar animal health guar-antees; in that case, animal health conditions at least equivalent tothose in Annex A to that Directive shall be laid down in accordancewith the same procedure in order to permit the entry of such animalsinto semen collection centres.1988L0407 — EN — 11.06.2003 — 006.001 — 7
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4. Article 4 shall apply mutatis mutandis .
Article 11
1. Member States shall authorize the importationof semenon ly on
submission of an animal health certificate drawn up and signed by anofficial veterinarian of the third country of collection.
This certificate must:
(a) be drawn up in at least one of the official languages of the Member
State of destination and one of those of the Member State wherethe import control provided for in Article 12 is carried out;
(b) accompany the semen in the original;
(c) be drawnup ona sin gle sheet of paper;
(d) be made out to a single consignee.
2. The certificate must correspond to a specimen drawn up in accor-
dance with ►
M5the procedure referred to inArticle 18(2) ◄.
Article 12
The rules laid downinCoun cil Directive 90/675/EEC of 10 December
1990 laying down the principles governing the organization of veter-inary checks on products entering the Community from thirdcountries (
1) shall apply in particular to the organization and follow-up
of checks to be carried out by the Member States and the safeguardmeasures to be applied.
CHAPTER IV
Safeguardandcontrolmeasures
Article 15
The rules laid down in Council Directive 90/425/EEC of 26 June 1990
concerning veterinary and zootechnical checks in intra-Community
trade in certain live animals and products with a view to the comple-
tion of the internal market (2), shall apply inparticular to checks at
origin, to the organization of, and follow-up to, the checks to be carriedout by the Member State of destination, and follow up to, the checks tobe carried out by the Member State of destination, and to the safeguardmeasures to be implemented.
Article 16
1. Veterinary experts from the Commission may, in cooperation
with the competent authorities of the Member States and third coun-
tries, make on-the-spot checks in so far as that is indispensable forensuring uniform application of this Directive.
The country of collection within whose territory a check is being
carried out shall give all necessary assistance to the experts in carrying
out their duties. The Commission shall inform the country of collection
concerned of the results of the investigation.
The country of collection concerned shall take any measures which
may prove necessary to take account of the results of the investigation.If the country of collection does not take those measures, the Commis-1988L0407 — EN — 11.06.2003 — 006.001 — 8
(1) OJ No L 373, 31. 12. 1990, p. 1. Directive as last amended by Regulation
(EEC) No 1601/92 (OJ No L 173, 27. 6. 1992, p. 13.
(2) OJ No L 224, 18. 8. 1990, p. 29.▼M3
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sion may, after the situation has been examined by the Standing Veter-
inary Committee, have recourse to the provisions of the fourthsubparagraph of Article 5 (2) and 9 (1).
2. The general provisions for implementing this Article, especially
as regards the frequency and method of carrying out the checksreferred to inthe first subparagraph of paragraph 1, shall be laiddowninaccordan ce with ►
M5the procedure referred to inArticle
18(2)◄.
CHAPTER V
Finalprovisions
Article 17
Annex A shall be amended by the Council, acting by qualified majority
ona proposal from the Commission , inparticular to adapt it to
advances in technology.
Annexes B, C and D shall be amended in accordance with the proce-
dure laid downinArticle 18(2).
Article 18
1. The Commission shall be assisted by the Standing Committee on
the Food Chain and Animal Health set up by Regulation (EC) No 178/2002 (
1).
2. Where reference is made to this paragraph, Articles 5 and 7 of
Decision1999/468/EC (2) shall apply.
The period referred to inArticle 5(6) of Decision1999/468/EC shall be
set at three months.
3. The Committee shall adopt its rules of procedure.
Article 20
1. This Directive shall not be applicable to semen collected and
processed ina Member State before 1 Jan uary 1990.
2. Until the date of entry into force of the decisions adopted
pursuant to Articles 8, 9 and 10, the Member States shall not apply to
imports of semen from third countries more favourable conditions than
those resulting from application of Chapter II.
Article 21
The Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Directive by 1January 1990 at the latest. They shall forthwith inform the Commissionthereof.
Article 22
This Directive is addressed to the Member States.1988L0407 — EN — 11.06.2003 — 006.001 — 9
(1) OJ L 31, 1.2.2002, p. 1.
(2) OJ L 184, 17.7.1999, p. 23.▼M5
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ANNEX A
CHAPTER I
CONDITIONSFORTHEOFFICIALAPPROVALOFCENTRES
1. Semencollectioncen tres must:
(a) be placed under the permanent supervision of a centre veterinarian
authorised by the competent authority;
(b) have at 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 has no direct communication with
the normal animal accommodation;
(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. Semenstorage cen tres must:
(a) be placed under the permanent supervision of a centre veterinarian
authorised by the competent authority;
(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 OFFICIAL SUPERVISION OF
CENTRES
1. Collectioncen tres must:
(a) be so supervised that they contain only animals of the species whose
semenis to be collected. Other domestic an imals which are strictly
necessary for the normal operation of the collection centre may nonethe-
less also be admitted, provided that they present no risk of infection to
those species whose semenis to be collected, an d 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 super-
vision;
(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 proce-
dures and hygiene techniques relevant to the control of the spread of
disease;
(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) of Annex B,1988L0407 — EN — 11.06.2003 — 006.001 — 10
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— 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 inpoin t (vii);
Deep-frozenembryos may also be stored inapproved cen tres
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 (1),
— the embryos are stored in separate storage containers 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 instruments which come into contact with the semen or the
donor animal during collection and processing are properly disin-
fected or sterilised prior to use, except for single-use instruments;
(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 suchrisk is prevented;
(v) storage containers and transport containers are either properly
disinfected or sterilised before the commencement of each filling
operation, except for single-use 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 used in its territory;
(viii) the storage unit must comply with specific conditions relating to
the supervision of semen storage centres provided for in point 2.
2. 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 this Directive;
(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;
(d) employ technically competent staff suitably trained in disinfection proce-
dures 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 this Directive is stored inapproved storage cen tres, without
coming into contact with any other semen.
In addition, only semen coming from an approved collection or
storage centre and transported in conditions offering every possible
health guarantee, having had no contact with any other semen, may
be brought into an approved storage centre.1988L0407 — EN — 11.06.2003 — 006.001 — 11
(1) OJ L 302, 19.10.1989, p. 1. Directive as last amended by Commission Decision 94/113/
EC (OJ L 53, 24.2.1994, p. 23).
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Deep-frozenembryos may also be stored inapproved cen tres
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 containers in the
premises for storing approved semen;
(ii) storage of sementakes place on ly onthe premises set aside for the
purpose and under the strictest conditions of hygiene;
(iii) all instruments which come into contact with the semen are properly
disinfected or sterilised prior to use, except for single-use instru-
ments;
(iv) storage containers and transport containers are either properly disin-
fected or sterilised before the commencement of each filling
operation, except for single-use 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 collection centre
canbe readily established; each Member State shall commun icate
to the Commission and other Member States the characteristics and
form of the marking used in its territory.1988L0407 — EN — 11.06.2003 — 006.001 — 12
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ANNEX B
CHAPTER I
CONDITIONS APPLYING TO THE MOVEMENT OF ANIMALS INTO
APPROVEDSEMENCOLLECTIONCENTRES
1. For all bovine animals admitted to a semen collection centre the following
requirements shall apply:
(a) they must have been subjected to a period of quarantine of at least 28
days inaccommodationspecifically 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
must have belonged to a herd which is officially tuberculosis free and
officially brucellosis free inaccordan ce with Directive 64/432/EEC. The
animals shall not previously have been kept in a herd of a lower status;
(c) they must come from a herd officially free of enzootic bovine leukosis as
defin ed inDirective 64/432/EEC, or have beenproduced by dams which
have beensubjected, with n egative results, to a test carried out inaccor-
dance with Annex D (Chapter II) to 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 the 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;
(iii) for enzootic bovine leukosis, a serological test carried out in accor-
dance with the procedure laid down in Annex D (Chapter II) to
Directive 64/432/EEC;
(iv) for IBR/IPV, a serological test (whole virus) ona blood sample if
the animals do not 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 antibo-
dies.
The competent authority may give authorisation for the tests referred to
in (d) to be carried out on samples collected in the quarantine station. In
this case, the period of quarantine referred to in (a) may not commence
before the date of sampling. However, should any of the tests listed in (a)
prove positive, the animal concerned shall be immediately removed from
the isolation unit. In the event of group isolation, the quarantine period
referred to in (a) may not commence for the remaining animals until the
animal which tested positive has been removed.
(e) within the period of quarantine specified in (a), and at least 21 days after
being admitted to quarantine (at least seven days after being admitted to
quarantine to search for Campylobacter fetus ssp.venerealis andTricho-
monas foetus ), they have beensubjected to the followin g tests with
negative results in each case, except for the BVD/MD antibody test (see
point (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) ona blood sample;
If any animals test positive, these animals shall be removed imme-
diately 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 antibo-
dies.1988L0407 — EN — 11.06.2003 — 006.001 — 13
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Any animal (seronegative or seropositive) may only be allowed
entry to the semen collection facilities if no sero-conversion occurs
in animals which tested seronegative before entry into the quaran-
tine station.
If sero-conversion occurs, all 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. Serologi-
cally positive animals may be allowed entry into the semen
collectionfacilities;
(iv) forCampylobacter fetus ssp.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) forTrichomonas 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 single test 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 forth-
with 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.
(f) prior to the initial dispatch of semen from BVD/MD serologically posi-
tive bulls, a semensample from each an imal 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
semendestroyed.
2. All tests must be carried out ina 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 isolationaccommodation , as referred to in
paragraph 1(a), which on the day of consignment officially fulfils the
following conditions:
(a) is situated inthe cen tre of anarea of 10 kilometres radius inwhich 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 beenfree from those bovin e 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 move-
ment from one semen collection centre to another takes place between
Member States it must take place inaccordan ce with Directive 64/432/EEC.
CHAPTER II
ROUTINE TESTS WHICH MUST BE APPLIEDTO ALL BOVINE
ANIMALSINANAPPROVEDSEMENCOLLECTIONCENTRE
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;1988L0407 — EN — 11.06.2003 — 006.001 — 14
▼M5
(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 leukosis, a serological test carried out in accor-
dance with the procedure described in Annex D (Chapter II) to
Directive 64/432/EEC;
(d) for IBR/IPV, a serological test (whole virus) ona blood sample;
(e) for BVD/MD, a serological antibody which is applied only to serone-
gative animals;
Should anan imal 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) forCampylobacter fetus ssp.venerealis , a test ona sample of prepu-
tial specimen. Only bulls on semen production or having contact with
bulls on semen production need to be tested. Bulls returning to collec-
tion after a lay-off of more than six months shall be tested not more
than 30 days prior to resuming production;
(g) forTrichomonas foetus , a test ona 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 ina laboratory approved by the Member
State.
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 beentested BVD/MD virus n egative.
Semen collected from all other animals at the centre since the date when
the positive test was carried out shall be held inseparate storage an d may
not be the subject of intra-Community trade until the health status of the
centre has been restored.1988L0407 — EN — 11.06.2003 — 006.001 — 15
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ANNEX C
CONDITIONSWHICHSEMENFORINTRA-COMMUNITYTRADEOR
IMPORTEDINTOTHECOMMUNITYMUSTSATISFY
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 collectionshall be submitted to a 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 collectionof 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 kilo-
metres radius in which there has been no case of foot-and-mouth
disease for at least 30 days;
(g) have been kept in semen collection centres which, during the period
commencing 30 days prior to collection and ending 30 days after collec-
tion of the semen or, in the case of fresh semen, until the date of
dispatch, have beenfree from those bovin e diseases which are compulso-
rily 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 mycoplasmas may be used.
Immediately after their additionthe diluted semenmust be kept at a tempera-
ture of at least 5 ºC 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 containers 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.1988L0407 — EN — 11.06.2003 — 006.001 — 16
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ANNEX D
1988L0407 — EN — 11.06.2003 — 006.001 — 17