1988L0407 — EN — 12.03.1990 — 001.001 — 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
ofdeep-frozensemenofdomesticanimalsofthebovinespecies
(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
▼B
COUNCILDIRECTIVE
of14June1988
laying down the animal health requirements applicable to intra-
Communitytradeinandimportsofdeep-frozensemenofdomestic
animalsofthebovinespecies
(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 — 12.03.1990 — 001.001 — 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.
▼B
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 ofa 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 ofthis Directive; whereas it must be possible to return such semen if this
is not contrary to considerations of animal health and if the consignor
or 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 of
semen 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 anotherMember State or in a third country; whereas the dangers associatedwith such diseases and the protective measures they necessitate should
be assessed in the same way throughout the Community; 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;
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 deep-
frozen 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 shall
apply 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 or
third 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 — 12.03.1990 — 001.001 — 3
▼B
(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 anotherMember 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-Community
trade 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, until 31
December 1992 authorize the admission of semen from bulls giving anegative reaction to the serum neutralization test or the Elisa test for
infectious bovine rhino-tracheitis/infectious pustular vulvo-vaginitis or
showing a positive result after vaccination in accordance with thisDirective.
Member States may, until 31 December 1992, authorize the admission
of semen of bulls giving a positive reaction to the serum neutralization
test or the Elisa test for infectious bovine rhino-tracheitis/infectious
pustular 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 a virus isolation test.
This requirement shall not apply in respect of the semen of animals
which, prior to their first vaccination at the insemination centre, reacted
negatively to the tests referred to in the first paragraph.
These examinations can, by bilateral agreement, be carried out either in
the country of collection or in the country of destination.
Before 1 January 1992, the Council shall review this paragraph on the
basis of a Commission report accompanied, if appropriate, by propo-
sals.
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 nothave that status.1988L0407 — EN — 12.03.1990 — 001.001 — 4
▼B
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 contain
only animalsgiving a negative reaction to the s erum neutralization
test or the Elisa test.
3. Without prejudice to other Community provisions, Member States
which do not practise vaccination against foot-and-mouth disease maynot oppose the admission of semen from animals vaccinated in accor-dance with thisDirective.
In that event, up to 10 % of the semen from each collection intended
for trade (with a minimum of five straws) may be subjected to a virus
isolation test for foot-and-mouth in a laboratory in the Member Statesof destination or in a laboratory specified by that Member State. If theresult is positive, admission of the semen may be refused.
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 wherethe 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.
When a Member State considers that the provisions governing approval
are not, or are no longer, observed in a semen collection centre inanother Member State, it shall inform the competent authority of theState. The latter shall then take all necessary measures and notify thecompetent authority of the other Member State of the decisions taken
and the reasons for them.
If that other Member State fears that the necessary measures have not
been taken or are inadequate, it shall so inform the Commission, which
shall seek the opinion of one or more veterinary experts. In the light ofthat opinion, Member Statesmay be authorized, in accordance with theprocedure laid down in Article 19, to prohibit temporarily the admis-sion of semen coming from the centre in question.
Such authorization may be withdrawn in accordance with the procedure
laid down in Article 19 in the light of a fresh opinion delivered by one
or more veterinary experts.
The veterinary expertsmus t be nationalsof a Member State other than
those involved in the dispute.
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;1988L0407 — EN — 12.03.1990 — 001.001 — 5
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(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.
(c) Decisions taken under (a) or (b) must, at the request of the
consignor or his representative, authorize the return of the
semen, 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 of
collection doesnot within 30 daysauthorize the return of the s emen,
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 his
representative, together with the reasons therefor.
Article 7
1. Avenuesof appeal provided for in current legis lation in the
Member States against decisions taken pursuant to this Directive by
the competent authority shall not be affected by this Directive.
These reasoned decisions must, on request, be communicated to the
consignor or his representative forthwith in writing, with an indication
of what avenuesof appeal agains t them are provided for in current
legislation and of the form and time limits in which proceedings mustbe initiated. The decisions must also be communicated to the compe-tent veterinary authority of the Member State of collection orprovenance.
2. Each Member State shall grant to consignors in respect of whose
consignments of semen such measures as are provided for in Article 6(2) have been taken, the right to obtain, before other measures aretaken by the competent authority, the opinion of a veterinary expert to
determine whether Article 6 (2) hasbeen complied with.
The veterinary expert must be a national of a Member State other than
the Member State of collection or of destination.
The Commission shall, on a proposal from the Member States, draw up
a list of veterinary experts who may be instructed to formulate suchopinions. The general rules for applying this Article, and in particularthe procedure to be followed in formulating these opinions, shall beadopted in accordance with the procedure laid down in Article 18.
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 that1988L0407 — EN — 12.03.1990 — 001.001 — 6
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country, 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 production
systems in the third country, the powers of the veterinary services and
the supervision to which semen collection centres are subject.
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 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 thisArticle,
the Member States shall not authorize the importation of semen from a
third country on the list unless the semen complies with the animal
health 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;1988L0407 — EN — 12.03.1990 — 001.001 — 7
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(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, 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 that
case, animal health conditions at least equivalent to those in Annex A
to that Directive shall be laid down in accordance with the same proce-dure in order to permit the entry of such animals into semen collectioncentres.
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 an
official 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.
Article 12
1. Member States shall ensure that each consignment of semen
entering the customs territory of the Community is subjected to controlbefore being released for free circulation or placed under a customsprocedure and shall prohibit the introduction of such semen into theCommunity if the import control made on arrival revealsthat:
— the semen does not come from the territory of a third country on
the list drawn up in accordance with Article 8 (1),
— the semen does not come from a semen collection centre on the list
provided for in Article 9 (1),
— the semen comes from the territory of a third country from which
importsare prohibited in accordance with Article 15 (2),
— the animal health certificate which accompaniesthe s emen isnot in
conformity with the conditionslaid down in Article 11 and fixed
pursuant thereto.
This paragraph shall not apply to consignments of semen which arrive
in the customs territory of the Community and are placed under a
customs transit procedure for consignment to a destination situated
outside the said territory.
However, it shall be applicable where customs transit is waived during
transport throught the territory of the Community.
2. The Member State of destination may take the necessary
measures, including storage in quarantine, in order to obtain definiteproof in cases where semen is suspected of being contaminated bypathogenic organisms.
3. If the introduction of semen has been prohibited on any of the
groundss et out in paragraphs1 and 2 and the exporting third countrydoesnot within 30 daysauthorize the return of the s emen, the compe-tent veterinary authority of the Member State of destination may orderit to be destroyed.1988L0407 — EN — 12.03.1990 — 001.001 — 8
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Article 13
Each consignment of semen authorized for introduction into the
Community by a Member State on the basis of the control referred to
in Article 12 (1) must, when sent to the territory of another Member
State, be accompanied by the original certificate or an authenticatedcopy thereof, suitably endorsed, in either case, by the competentauthority which was responsible for the examination carried out inaccordance with Article 12.
Article 14
If it is decided to take destruction measures pursuant to Article 12 (3),
any costs incurred shall be chargeable to the consignor, the consignee
or their agent, without compensation by the State.
CHAPTER IV
Safeguardandcontrolmeasures
Article 15
1. A Member State may take the following measures if there is a
danger of an animal disease spreading as a result of the introduction
of semen into its territory from another Member State:
(a) in the event of an outbreak of an epizootic disease in the other
Member State, it may temporarily prohibit or restrict the introduc-tion of semen from the areas of that Member State where thedisease has occurred;
(b) if an epizootic disease becomes widespread, or if there is an
outbreak of a further contagious animal disease of a serious nature,it may temporarily prohibit or restrict the introduction of semenfrom the whole of the territory of that Member State.
Each Member State shall immediately inform the other Member States
and the Commission of the outbreak on its territory of any diseasecovered by the first subparagraph and of the measures which it hastaken to control that disease. It shall also notify them immediately ofthe disappearance of the disease.
2. Without prejudice to Article 8, 9 and 10, if in a third country a
contagious animal disease which can be carried by semen and is liable
to endanger the health of the livestock in a Member State breaks out orspreads or if any other reason connected with animal health so justifies,the Member State of destination concerned shall prohibit the importa-tion of that semen, whether imported directly or indirectly through
another Member State, either from the whole of the third country or
from part of itsterritory.
3. Measures taken by the Member States on the basis of paragraphs
1 and 2 and the repeal of such measures must be communicated imme-diately to the other Member States and the Commission together withthe reasons for such measures.
In accordance with the procedure laid down in Article 18, it may be
decided that those measures must be amended, in particular in orderto coordinate them with measures adopted by the other Member States,or that they must be repealed.
4. If the situation envisaged in paragraphs 1 and 2 arises and if it is
necessary that other Member States also apply the measures taken
under those paragraphs, amended where necessary in accordance with
paragraph 3, appropriate steps shall be taken in accordance with theprocedure laid down in Article 18.
5. Resumption of importation from the third country concerned shall
be authorized in accordance with the procedure laid down in Article18.1988L0407 — EN — 12.03.1990 — 001.001 — 9
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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 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-
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 checks
referred 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.
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 by
the 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 tothe Council a proposal relating to the measures to be taken. TheCouncil 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, theCommission 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.1988L0407 — EN — 12.03.1990 — 001.001 — 10
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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 opinionshall 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 tothe 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.
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 Commissionthereof.
Article 22
This Directive is addressed to the Member States.1988L0407 — EN — 12.03.1990 — 001.001 — 11
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ANNEX A
CHAPTER I
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.
CHAPTER II
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 — 12.03.1990 — 001.001 — 12
▼B
(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 and the breed and identification of the
donor animal, as well as the name of the centre, possibly in code, can
be readily established; the characteristics and form of this marking will
be established in accordance with the procedure laid down in Article
19.1988L0407 — EN — 12.03.1990 — 001.001 — 13
▼B
ANNEX B
CHAPTER I
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 herds:
(i) which are officially tuberculosis free;
(ii) which are officially brucellosis free or brucellosis free.
The animalsmay not previous ly have been kept in other herdsof a lower
status;
(c) have come from a herd free of enzootic bovine leukosis or have been
produced by a cow which has been subjected to a serological test for
enzootic bovine leukosis with a negative result, not more than 30 days
before the animal's admission to the centre.
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 laid down in Annex C to Directive 64/432/EEC and showing a
brucella count lower than 30 IU of agglutination per millilitre and in
the case of brucellosis free herds a complement fixation test
showing a brucella count lower than 20 EEC units per 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 laid down
in Annex C to Directive 64/432/EEC and showing a brucella count
lower than 30 IU of agglutination per millilitre and a complement
fixation test showing a brucella count lower than 20 EEC units per
millilitre (20 ICFT units) in the case of animals coming from
brucellosis free herds;
(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;
and have treatment against leptospirosis comprising two injections of
streptomycin at an interval of 14 days (25 mg per kilogram of live body
weight).1988L0407 — EN — 12.03.1990 — 001.001 — 14
▼B
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.
CHAPTER II
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 laid down in Annex C to Directive 64/432/EEC, giving a
count lower than 30 IU of agglutination per millilitre;
(iii) a serological test for enzootic bovine leukosis, carried out in accordance
with the procedure laid down in Annex G to Directive 64/432/EEC, with
a negative result; ►M1however, until 30 June 1990 Member States
may disregard the results of the test provided that the semen has been
subjected, with a negative result, to a test for the presence of white
blood cells. Member States exercising this option shall take all the
necessary measures to ensure that such semen or embryos resulting
therefrom do not enter into intra-Community trade; ◄
(iv) for infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis, a
serum neutralization test or an ELISA test with a negative result.
However until 31 December 1992:
— 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,
— 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 antibody1988L0407 — EN — 12.03.1990 — 001.001 — 15
▼M1
▼B
▼B
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.
However, until 31 December 1992:
— 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 tes t for infectiousbovine rhinotracheitisor infectiouspus tular
vulvovaginitis;
— 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-Commu-
nity trade in accordance with the provisions for trade in semen from such
bulls under Article 4 (1) second, third, fourth and fifth subparagraphs.1988L0407 — EN — 12.03.1990 — 001.001 — 16
▼M1
▼B
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; or
(ii) come from a centre where all the animalshave been fully protected
against types A, O and C;
— and are thuseither animalswhich ►M1 ◄were
not previously vaccinated against foot-and-mouth disease and
must, therefore, have received two doses of inactivated virus
vaccine approved and controlled by the competent authority of
the exporting Member State at an interval of not less than six
weeksand not more than eight months ,
— or animalswhich ►M1 ◄were vaccinated on at
least three occasions at intervals of not more than one year.
When vaccination is practised, all animals must receive repeat vacci-
nationsat intervalsof not more than 12 months ;
(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 collection of the 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 daysafter collection, and are s ituated 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, have been free from those bovine diseases which are
compulsorily 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;
(ii) be transported to the Member State of destination in flasks which have
been cleaned and disinfected or sterilized before use ►
M1and which
have been sealed and numbered prior to dispatch from the approved
storage facilities ◄.1988L0407 — EN — 12.03.1990 — 001.001 — 17
▼B
ANNEX D
1988L0407 — EN — 12.03.1990 — 001.001 — 18
▼M1
1988L0407 — EN — 12.03.1990 — 001.001 — 19