1988L0407 — EN — 28.07.1993 — 003.001 — 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
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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),
Whereasprovis ionsrelating to animal health problemsin intra-
Community trade in bovine animalsand s wine appear in Directive 64/432/EEC(
4), aslas t amended by Regulation (EEC) No 3768/85(5);
whereasin addition, Directive 72/462/EEC(6), aslas t amended by
Regulation (EEC) No 3768/85 containsprovis ionsrelating 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 importsinto 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 in semen;
Whereasin 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 semen is collected should be under an obliga-
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 thisobligation hasbeen fulfilled;
Whereasthe difference in the policiespurs ued 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, in respect of certain diseases, of additional protec-tion against those diseases;
Whereasfor importsof s emen 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 importation of semen only from semen collec-tion centreswhich reach certain s tandardsand which are officially1988L0407 — EN — 28.07.1993 — 003.001 — 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, in addition, in respect of countries on that 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 between Member States as to whether approval of
a collection centre isjus tified;
Whereas the Member States may refuse a consignment of semen where
it has been established that it does not comply with the provisions of
this Directive; whereas it must be possible to return such semen if 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 orrestriction 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 ofsemen arrives on the territory of the Community, except in the case of
external transit;
Whereas after such control, in the case of internal transit, the measures
to be taken by Member Statesmus t be defined;
Whereasa Member State s hould be permitted to take emergency
measures in the event of an outbreak of a contagious disease in another
Member State or in a third country; whereas the dangers associated
with such diseases and the protective measures they necessitate shouldbe assessed in the same way throughout the Community; whereas tothat 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 Veterinary
Committee;
WhereasthisDirective doesnot affect trade in s emen produced before
the date on which the Member Statesmus t comply with it.
HAS ADOPTED THIS DIRECTIVE:
CHAPTER I
General provisions
Article 1
ThisDirective laysdown the animal health conditionsapplicable to
intra-Community trade in and importsfrom third countriesof►
M3 ◄semen of domestic animals of the bovine
species.
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 shallapply as necessary.
Moreover:
(a) ‘semen’ means the prepared or diluted ejaculate of a domestic
animal of the bovine species;
(b) ‘semen collection centre’ means an officially approved and super-
vised establishment situated in the territory of a Member State orthird country, in which semen is produced for use in artificial inse-mination;
(c) ‘official veterinarian’ meansthe veterinarian des ignated by the
competent central authority of a Member State or a third country;1988L0407 — EN — 28.07.1993 — 003.001 — 3
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(d) ‘centre veterinarian’ means the veterinarian responsible for day-to-
day compliance in the centre with the requirementslaid down inthisDirective;
(e) ‘consignment’ means a quantity of semen covered by a single certi-
ficate;
(f) ‘country of collection’ meansthe Member State or third country in
which semen is collected and from which it is sent to a MemberState;
(g) ‘approved laboratory’ meansa laboratory s ituated 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’ meansa quantity of s emen 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 conditionsiss ent from itsterritory to the territory of another
Member State;
(a) it must have been collected and processed, for the purpose of arti-
ficial insemination, in a semen collection centre approved from thepoint of view of animal health for the purposes of intra-Communitytrade in accordance with Article 5 (1);
(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 AnnexesA 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
1. Without prejudice to paragraph 2, Member Statess hall authorize
the admission of semen from bulls giving a negative reaction to theserum neutralization test or the Elisa test for infectious bovine rhinotra-cheitis/infectious pustular vulvo-vaginitis or showing a positive resultafter vaccination in accordance with thisDirective.
Member States may, until 31 December 1998, authorize the admission
of semen of bulls giving a positive reaction to the serum neutralizationtest or the Elisa test for infectious bovine rhinotracheitis/infectiouspustular vulvo-vaginitis and not having been vaccinated in accordancewith thisDirective.
In that case, each consignment must pass an examination by inocula-
tion into a live animal and/or virus isolation test.
This requirement shall not apply in respect of the semen of animals
which, prior to their first routine vaccination at the insemination centre,reacted negatively to the tests referred to in the first subparagraph.However, the semen of animals given emergency vaccinations
following an outbreak of IBR must pass a virus isolation test.
These examinations may, by bilateral agreement, be carried out either
in the country of collection or in the country of destination.
In that case, at least 10 % of each collection of semen (with a
minimum of five straws) must be treated.
Protocols for tests to be used in accordance with this Article shall be
laid down in accordance with the procedure in Article 18.1988L0407 — EN — 28.07.1993 — 003.001 — 4
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2. Member Statesin which all centrescontain only animalsgiving a
negative reaction to the serum neutralization test or the Elisa test mayrefuse admission to their territory of semen from centres which do not
have that status.
In accordance with the procedure referred to in Article 19, it may be
decided to extend the above provisions to part of the territory of aMember State if all the centresof that part of the territory containonly animalsgiving a negative reaction to the s erum neutralization
test or the Elisa test.
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 semen from each collection (with a minimum of fivestraws) intended for sending to another Member States shall besubjected, in a laboratory in the Member State of destination or in alaboratory designated by it, to a virus isolation test for foot-and-mouth
disease, with negative results.
Article 5
1. The Member State on whose territory the semen collection centre
is situated shall ensure that the approval provided for in Article 3 (a) isgranted only where the provisions of Annex A are observed and where
the semen collection centre 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 semen collection centres shall be registered, each
centre being given a veterinary registration number. Each MemberState shall send a list of semen collection centres and their veterinaryregistration numbers to the other Member States and to the Commis-sion and shall notify them of any withdrawal of approval.
The general rulesfor applying thisArticle s hall be adopted in accor-
dance with the procedure laid down in Article 18.
Article 6
1. Member States shall make the admission of semen conditional
upon submission of an animal health certificate drawn up by an officialveterinarian of the Member State of collection in accordance withAnnex D.
Thiscertificate mus t:
(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 drawn up on a single 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 hasnot 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 beinginfected or contaminated by pathogenic organisms.1988L0407 — EN — 28.07.1993 — 003.001 — 5
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(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 animal
health.
3. If the admission of semen has been prohibited on any of the
groundss et out in paragraph 2 (a) and (b) and the Member State ofcollection doesnot within 30 daysauthorize the return of the s emen,
the competent veterinary authority of the Member State of destination
may 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.
CHAPTER III
Importsfromthirdcountries
Article 8
1. A Member State may authorize importation of semen only from
those third countries which appear on a list drawn up in accordance
with the procedure laid down in Article 19. That list may be supple-mented or amended in accordance with the procedure laid down inArticle 18.
2. In deciding whether a third country may appear on the list
referred to in paragraph 1, particular account shall be taken of:
(a) the state of health of the livestock, other domestic animals and
wildlife in the third country, with particular reference to exoticanimal diseases, and of the environmental health situation in thatcountry, which might endanger animal health in the Member
States;
(b) the regularity and rapidity of the information supplied by the third
country concerning the existence of contagious animal diseases in
its territory, in particular those diseases mentioned in lists A andB 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 guaranteeswhich the third country can give with regard to
compliance with thisDirective.
3. The list referred to in paragraph 1 and all amendments thereto
shall be published in the Official Journal of the European Commu-
nities.
Article 9
1. In accordance with the procedure laid down in Article 19, a list
shall be drawn up of semen collection centres from which MemberStatesmay authorize the importation of s emen originating in thirdcountries. The list may be amended or supplemented according to thesame procedure.
2. In deciding whether a semen collection centre in a third country
may appear on the list referred to in paragraph 1, particular accountshall be taken of the veterinary supervision of semen productionsystems in the third country, the powers of the veterinary services andthe supervision to which semen collection centres are subject.1988L0407 — EN — 28.07.1993 — 003.001 — 6
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3. A semen collection centre may appear on the list provided for in
paragraph 1 only if:
(a) it is situated in one of the countries on the list referred to in Article
8 (1);
(b) it fulfilsthe requirementsof ChaptersI and II of Annex A;
(c) it hasbeen officially approved for exportsto the Community 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. Semen must come from animals which, immediately prior to
collection of their semen, have remained for at least six months in the
territory of a third country on the list drawn up in accordance with
Article 8 (1).
2. Without prejudice to Article 8 (1) and paragraph 1 of thisArticle,
the Member States shall not authorize the importation of semen from athird country on the list unless the semen complies with the animalhealth requirementsadopted, in accordance with the procedure laiddown in Article 18, for importsof s emen from that country.
In adopting the requirementsreferred to in the preceding s ubparagraph,
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 in the semen collection centre,
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 be
the standards laid down in Annex A to Directive 64/432/EEC. It may
be decided, in accordance with the procedure laid down in Article 18,on a case-by-case basis, to waive these conditions where the thirdcountry concerned provides similar animal health guarantees; in thatcase, animal health conditions at least equivalent to those in Annex Ato that Directive shall be laid down in accordance with the same proce-
dure in order to permit the entry of such animals into semen collection
centres.
4. Article 4 shall apply mutatis mutandis .
Article 11
1. Member States shall authorize the importation of semen only on
submission of an animal health certificate drawn up and signed by anofficial veterinarian of the third country of collection.
Thiscertificate mus t:
(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 iscarried out;
(b) accompany the semen in the original;
(c) be drawn up on a single 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 the procedure laid down in Article 19.1988L0407 — EN — 28.07.1993 — 003.001 — 7
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Article 12
The ruleslaid down in Council Directive 90/675/EEC of 10 December
1990 laying down the principlesgoverning the organization of veter-
inary checkson productsentering the Community from thirdcountries(
1) shall apply in particular to the organization and follow-up
of checksto be carried out by the Member Statesand the s afeguardmeasures to be applied.
CHAPTER IV
Safeguardandcontrolmeasures
Article 15
The ruleslaid down in Council Directive 90/425/EEC of 26 June 1990
concerning veterinary and zootechnical checksin intra-Communitytrade in certain live animalsand productswith a view to the comple-
tion of the internal market(
2), shall apply in particular to checks at
origin, to the organization of, and follow-up to, the checksto 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 authoritiesof the Member Statesand third coun-tries, make on-the-spot checks in so far as that is indispensable for
ensuring 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 carryingout their duties. The Commission shall inform the country of collectionconcerned 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-sion may, after the situation has been examined by the StandingVeterinary 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
asregardsthe frequency and method of carrying out the checksreferred to in the first subparagraph of paragraph 1, shall be laiddown in accordance with the procedure set out in Article 19.
CHAPTER V
Finalprovisions
Article 17
Amendmentsto the Annexesto thisDirective, in particular to adapt
them to advancesin technology, s hall be decided by the Council actingby a qualified majority on a proposal from the Commission.1988L0407 — EN — 28.07.1993 — 003.001 — 8
(1) OJ No L 373, 31. 12. 1990, p. 1. Directive aslas t 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.▼B
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Article 18
1. Where the procedure laid down in thisArticle isto be followed,
matterss hall without delay be referred by the chairman, either on hisown initiative or at the request of a Member State, to the StandingVeterinary Committee (hereinafter called ‘the committee’) set up bythe Council Decision of 15 October 1968.
2. Within the committee the votesof the Member Statess hall be
weighted asprovided for in Article 148 (2) of the Treaty. The chairmanshall not vote.
3. The representative of the Commission shall submit a draft of the
measures to be adopted. The committee shall deliver its opinion onsuch measures within two days. Opinions shall be delivered by amajority of 54 votes.
4. The Commission shall adopt the measures and apply them imme-
diately where they are in accordance with the committee'sopinion.Where they are not in accordance with the committee'sopinion or inthe absence of any opinion, the Commission shall forthwith submit to
the Council a proposal relating to the measures to be taken. The
Council shall adopt the measures by a qualified majority.
If, on the expiry of three monthsfrom the date on which the matter
was referred to it, the Council has not adopted any measures, the
Commission shall adopt the proposed measures and apply them imme-
diately, save where the Council has decided against the said measuresby a simple majority.
Article 19
1. Where the procedure laid down in thisArticle isto be followed,
matterss hall without delay be referred to the committee by thechairman, either on hisown initiative or at the reques t of a MemberState.
2. Within the committee the votesof the Member Statess hall be
weighted asprovided for in Article 148 (2) of the Treaty. The chairmanshall not vote.
3. The representative of the Commission shall submit to the
committee a draft of the measures to be adopted. The committee shalldeliver itsopinion on the draft within a time limit which the chairmanmay lay down according to the urgency of the matter. The opinion
shall be delivered by a majority of 54 votes.
4. The Commission shall adopt the measures and apply them imme-
diately where they are in accordance with the committee'sopinion.Where they are not in accordance with the committee'sopinion, or in
the absence of any opinion, the Commission shall forthwith submit to
the Council a proposal relating to the measures to be taken. TheCouncil shall adopt the measures by a qualified majority.
If, on the expiry of 15 daysfrom the date on which the matter was
referred to it, the Council has not adopted any measures, the Commis-sion shall adopt the proposed measures and apply them immediately,save where the Council has decided against the said measures by asimple majority.
Article 20
1. This Directive shall not be applicable to semen collected and
processed in a Member State before 1 January 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 toimportsof s emen from third countriesmore favourable conditionsthanthose resulting from application of Chapter II.1988L0407 — EN — 28.07.1993 — 003.001 — 9
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Article 21
The Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Directive by 1
January 1990 at the latest. They shall forthwith inform the Commission
thereof.
Article 22
This Directive is addressed to the Member States.1988L0407 — EN — 28.07.1993 — 003.001 — 10
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ANNEX A
CHAPTERI
CONDITIONS FOR THE APPROVAL OF SEMEN COLLECTION
CENTRES
Semen collection centresmus t:
(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 sterilization 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, proces-
sing and storage facilities can be readily cleaned and disinfected;
(e) have isolation accommodation which shall have no direct communication
with the normal animal accomodation;
(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.
CHAPTERII
CONDITIONS RELATING TO THE SUPERVISION OF SEMEN
COLLECTIONCENTRES
The collection centresmus t:
(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 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 detailsof 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, giving also information from the disease/health file of each
animal;
(c) be regularly inspected by an official veterinarian, at least twice a year, at
which time standing checks on the conditions of approval and supervision
shall be carried out;
(d) be so supervised that the entry of unauthorized persons is prevented.
Furthermore, authorized visitors must be required to comply with the condi-
tionslaid down by the centre veterinarian;
(e) employ technically competent staff suitably trained in disinfection proce-
duresand hygiene techniquesrelevant to the control of the s pread 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 consign-
ment 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
conditionslaid 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 equip-
ment in the latter case being cleaned and sterilized 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);1988L0407 — EN — 28.07.1993 — 003.001 — 11
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deep-frozen embryos may also be stored in approved centres provide that:
— such storage is authorized by the competent authority,
— the embryosmeet the requirementsof Council Directive 89/556/
EEC of 25 September 1989 on animal health conditionsgoverning
intra-Community trade in and importation from third countriesof
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 conditions of the strictest
hygiene;
(iii) all implementswhich come into contact with the s emen or the donor
animal during collection and processing are properly disinfected or
sterilized 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 properly disinfected or sterilized
before the commencement of each filling operation;
(vi) the cryogenic agent used has not been previously used for other
productsof 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, the name of the centre and the serological status of the
donor animal in respect of infectious bovine rhinotracheitis and infec-
tious pustular vulvo-vaginitis, possibly in code, can be readily
established; the characteristics and form of this marking will be estab-
lished in accordance with the procedure laid down in Article 19.1988L0407 — EN — 28.07.1993 — 003.001 — 12
(*) OJ No L 302, 19. 10. 1989, p. 1. Directive asamended by Directive 90/425/EEC (OJ
No L 224, 18. 8. 1990, pl. 29).▼B
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ANNEX B
CHAPTERI
CONDITIONS APPLYING TO THE MOVEMENT OF ANIMALS INTO
APPROVEDSEMENCOLLECTIONCENTRES
1. All bovine animals admitted to a semen collection centre must:
(a) have been subjected to a period of isolation of at least 30 days in accom-
modation 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 isolation accommodation described in (a), have
belonged to a herd which isofficially tuberculos isfree and officially
brucellosis free in accordance with Directive 64/432/EEC. The animals
may not previously have been kept in one or more herds of a lower
status;
(c)►M3have come from a herd free of enzootic bovine leucosis as
defined in Directive 64/432/EEC, or have been produced by damswhich
have been subjected, with negative results, to an Agar Gel immunodiffu-
sion test, carried out in accordance with Annex G of Directive 64/432/
EEC, after removal of the animalsfrom their ‘dam’ In the cas e of
animalsderived by embryo tans fer, ‘dam’ meansthe recipient of the
embryo. ◄
If this requirement cannot be fulfilled, the semen may not be the subject
of trade until the donor hasreached the age of two yearsand hasbeen
tested in accordance with Chapter II. 1 (iii) with a negative result;
(d) before the period of isolation specified in (a), and within the previous 30
days, have been subjected to the following tests with negative results:
(i) an intradermal tuberculin test carried out in accordance with the
procedure laid down in Annex B to Directive 64/432/EEC;
(ii) a serum agglutination test carried out in accordance with the proce-
dure described in Annex C to Directive 64/432/EEC and showing abrucella count lower than 30 IU of agglutination per millilitre, or a
complement fixation test showing a brucella count lower than 20
EEC unitsper millilitre (20 ICFT units );
(iii) a serological test for enzootic bovine leukosis carried out in accor-
dance with the procedure laid down in Annex G to Directive 64/
432/EEC;
(iv) a serum neutralization test or an Elisa test for infectious bovine
rhinotracheitis/infectious pustular vulvo-vaginitis;
(v) a virus isolation test (fluorescent antibody test or immunoperoxidase
test) for bovine viral diarrhoea. In the case of an animal less than
six months of age the test must be deferred until that age is reached.
The competent authority may give authorization for the tests referred to
in (d) to be carried out in the isolation accommodation, provided that the
results are known before the commencement of the 30-day isolation
period laid down in (e);
(e) during the period of isolation of at least 30 days specified in (a), have
been subjected to the following tests with negative results:
(i) a serum agglutination test complying with the procedure described
in Annex C to Directive 64/432/EEC and showing a brucella count
lower than 30 IU of agglutination per millilitre, or a complement
fixation test showing a brucella count lower than 20 EEC units per
millilitre (20 ICFT units);
(ii) either an immunofluorescent antibody test or a culture test for
campylobacter foetusinfection on a s ample of preputial material or
artificial vaginal washings; in the case of female animals a vaginal
mucus agglutination test shall be carried out;
(iii) a microscopic examination and culture test for trichomonas foetus
on a sample of vaginal washings or preputial washings; in the case
of female animals a vaginal mucus agglutination test shall be carried
out;
(iv) a serum neutralization test or an Elisa test for infectious bovine
rhinotracheitis/infectious pustular vulvo-vaginitis.1988L0407 — EN — 28.07.1993 — 003.001 — 13
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If any of the above tests should prove 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 thisAnnex.
2. All tests must be carried out in a laboratory approved by the Member State.
3. Animalsmay only be admitted to the s emen 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) iss ituated in the centre of an area of 10 kilometresradiusin 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 animalsof a lower health s tatusand 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 Statesit mus t take place in accordance with Directive 64/432/EEC.
6. However, until 1 July 1995 the Member Statesmay admit to approved s emen
collection centresanimalsof the bovine s peciesoriginating in herdswhich
are free of brucellosis. In that case, the animals must, during the aforemen-
tioned period, be subjected to a complement fixation test showing a brucella
count lower than 20 EEC unitsper millilitre (20 ICFT units ) asprovided for
in (d) (ii) and (e) (i).
CHAPTERII
ROUTINETESTSANDTREATMENT WHICH MUST BE APPLIEDTO
ALL BOVINE ANIMALS IN AN APPROVEDSEMEN COLLECTION
CENTRE
1. All bovine animalskept at an approved s emen collection centre mut be
subjected at least once a year to the following tests and treatment:
(i) an intradermal tuberculin test for tuberculosis, carried out in accordance
with the procedure laid down in Annex B to Directive 64/432/EEC, with
a negative result;
(ii) a serum agglutination test for brucellosis, carried out in accordance with
the procedure described in Annex C to Directive 64/432/EEC, giving a
count lower than 30 IU of agglutination per millilitre, or a complement
fixation test showing a brucella count lower than 20 EEC units per
millilitre (20 ICFT units);
(iii) a screening test for enzootic bovine leucosis, carried out in accordance
with the procedure described in Annex G to Directive 64/432/EEC, with
a negative result;
(iv) for infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis, a
serum neutralization test or an ELISA test with a negative result.
However ►M3 ◄:
— it is not necessary to carry out these tests on bulls which have
already been subjected to such tests and have given a positive result
to the serological test carried out in accordance with this Directive,1988L0407 — EN — 28.07.1993 — 003.001 — 14
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— vaccination against these diseases may be practised on sero-negative
bulls, either with one dose of a temperature-sensitive live vaccine
administered intranasally or two doses of an inactivated vaccine
separated by an interval of not less than three weeks and not more
than four weeks; the vaccination must be repeated subsequently at
intervals of not more than six months;
(v) either an immunofluorescent antibody test or a culture test for campylo-
bacter foetusinfection on a s ample of preputial material or artificial
vaginal washings; in the case of female animals a vaginal mucus agglu-
tination test must be carried out. ►M1However, bullswhich are not
used for the production of semen may be exempt from the antibody
test or a culture test for campylobacter foetus infection, with the proviso
that such bulls may not be re-admitted to semen production until they
have been subjected to such a test or culture and given a negative
result.◄
2. All tests must be carried out in a laboratory approved by the Member State.
3. If any of the above tests should prove 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.
Semen collected from all other animalsat the centre s ince 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 re-established.
These provisions shall not apply to sero-positive bulls which, prior to their
first vaccination in accordance with this Directive at the insemination centre,
gave a negative reaction to the serum neutralization test or the ELISA test for
infectiousbovine rhinotracheitisor infectiouspus tular vulvo-vaginitis .
Sero-positive bulls referred to in the second subparagraph of Article 4 (1)
must be isolated since their semen may be the subject of intra-Community
trade in accordance with the provisions for trade in semen from such bulls.1988L0407 — EN — 28.07.1993 — 003.001 — 15
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ANNEX C
CONDITIONS WHICH SEMEN COLLECTED AT APPROVED
CENTRESMUSTSATISFYFORTHEPURPOSESOFINTRA-COMMU-
NITYTRADE
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 monthsprior to collection, or
(ii) have been vaccinated against foot-and-mouth disease during the 12
monthsprior to collection, in which cas e 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 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 daysprior to collection and ending 30 daysafter collec-
tion of the semen or, in the case of fresh semen, until the date of
dispatch, have been free from those bovine diseases which are compulso-
rily notifiable in accordance with Annex E 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 IU per ml streptomycin,
500 IU per ml penicillin,
150 µg per ml lincomycin,300 µg per ml spectinomycin.
An alternative combination of antibioticswith an equivalent effect agains t
campylobacters, leptospires and mycoplasmas may be used.
Immediately after their addition the diluted semen must 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:
(i) be stored in approved conditions for a minimum period of 30 days prior
to dispatch. This requirement shall not apply to fresh semen;
(ii) be transported to the Member State of destination in flasks which have
been cleaned and disinfected or sterilized before use ►
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have been sealed and numbered prior to dispatch from the approved
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ANNEX D
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