1990L0429—EN—01.10.1999—002.001—1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE
of26June1990
layingdowntheanimalhealthrequirementsapplicabletointra-Communitytradeinandimports
ofsemenofdomesticanimalsoftheporcinespecies
(90/429/EEC
(OJL224,18.8.1990,p.62)
Amendedby:
OfficialJournal
No page date
►M1CommissionDecision1999/608/ECof10September1999 L242 20 14.9.1999
Amendedby:
►A1ActofAccessionofAustria,SwedenandFinland C241 21 29.8.1994
(adaptedbyCouncilDecision95/1/EC,Euratom,ECSC) L1 1 1.1.1995
▼B
COUNCILDIRECTIVE
of26June1990
laying down the animal health requirements applicable to intra-
Community trade in and imports of semen of domestic animals of
theporcinespecies
(90/429/EEC
THECOUNCILOFTHEEUROPEANCOMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community,andinparticularArticle43thereof,
HavingregardtotheproposalfromtheCommission(1),
HavingregardtotheopinionoftheEuropeanParliament(2),
Having regard to the opinion of the Economic and Social
Committee(3),
Whereas provisions relating to animal health problems in intra-
CommunitytradeinbovineanimalsandswineappearinDirective64/
432/EEC(4), as last amended by Directive 89/360/EEC(5); whereas in
addition, Directive 72/462/EEC(6), as last amended by Directive 89/
227/EEC(7) contains provisions relating to veterinary inspection
problems encountered upon importation of bovine animals and swinefromthirdcountries;
Whereas the abovementioned provisions have ensured, with regard to
intra-Community trade and imports into the Community of bovineanimalsandswinefromthirdcountries,thatthecountryofprovenanceguaranteesthatanimalhealthcriteriahavebeenfulfilledsothattheriskof animal disease spreading has been virtually eliminated; whereasthereisneverthelessacertainriskofthespreadofsuchdiseaseinthe
caseoftradeinsemen;
Whereas in the context of the Community policy of harmonizing
national animal health provisions governing intra-Community trade inanimals and animal products, it is now necessary to create a harmo-nized system for intra-Community trade and imports into the
Communityofsemenofporcineanimals;
Whereas, in the context of intra-Community trade in semen, the
MemberStatewherethesemeniscollectedshouldbeunderanobliga-tion to ensure that such semen has been collected and processed at
approved and supervised collection centres, has been obtained from
animalswhosehealthstatusissuchastoensurethattheriskofspreadof animal disease is eliminated, has been collected, processed, storedand transported in accordance with rules which preserve its healthstatusandisaccompaniedduringtransporttothecountryofdestinationby an animal health certificate in order to ensure that this obligation
hasbeenfulfilled;
Whereas the difference in the policies pursued within the Community
withregardtovaccinationagainstcertaindiseasesjustifiesthemainte-nance of derogations, limited in time, authorizing the requirement bytheMemberStates,inrespectofcertaindiseases,ofadditionalprotec-
tionagainstthosediseases;
WhereasforimportsofsemenintotheCommunityfromthirdcountries
alistofthirdcountriesshouldbedrawnuptakingintoaccountanimalhealthcriteria;whereasindependentlyofsuchalisttheMemberStatesshould authorize importation of semen only from semen collection1990L0429—EN—01.10.1999—002.001—2
(1) OJNoC267,6.10.1983,p.5.
(2) OJNoC342,19.12.1983,p.11.
(3) OJNoC140,28.5.1984,p.6.
(4) OJNo121,29.7.1964,p.1977/64.
(5) OJNoL153,6.6.1989,p.29.
(6) OJNoL302,31.12.1972,p.28.
(7) OJNoL93,6.4.1989,p.25.
▼B
centres which reach certain standards and which are officially super-
vised; whereas, in addition, in respect of countries on that list,specific animal health conditions should be laid down according to
circumstances; whereas,inordertoverifycompliance withthesestan-
dards,itmustbepossibletocarryouton-the-spotchecks;
Whereas the rules and procedures for checks laid down in Council
Directive 89/662/EEC of 11 December 1989 concerning veterinary
checksinintra-Community tradewithaviewtothecompletion ofthe
internalmarket(
1)shouldbeextendedtocoverthisDirective;
Whereas in order to prevent the transmission of certain contagious
diseases,importcontrolsshouldbecarriedoutwhenaconsignmentofsemenarrivesontheterritoryoftheCommunity,exceptinthecaseof
externaltransit;
Whereas a Member State should be permitted to take emergency
measuresintheeventofanoutbreakofacontagiousdiseaseinanotherMember State or in a third country; whereas the dangers associated
withsuchdiseasesandtheprotectivemeasurestheynecessitate should
be assessed in the same way throughout the Community; whereas tothat end,anemergency Community procedure underwhichthe neces-sary measures must be taken should be instituted within the StandingVeterinaryCommittee;
Whereas the Commission should be entrusted with taking certain
measuresforimplementingthisDirective;whereastothatend,aproce-dureshouldbeestablishedforcloseandeffectivecooperationbetweentheCommissionandtheMemberStateswithintheStandingVeterinaryCommittee;
WhereasthisDirectivedoesnotaffecttradeinsemenproducedbefore
thedateonwhichtheMemberStatesmustcomplywithit,
HASADOPTEDTHISDIRECTIVE:
CHAPTERI
General provisions
Article 1
This Directive lays down the animal health conditions applicable to
intra-Community trade in and imports from third countries of semenofdomesticanimalsoftheporcinespecies.
Article 2
ForthepurposesofthisDirective,thedefinitionscontainedinArticle2
of Directives 64/432/EEC, 72/462/EEC, 80/407/EEC(
2) and 90/425/
EEC(3)shallapplyasnecessary.
Moreover, ‘semen’ means the ejaculate of a domestic animal of the
porcinespecies,intheunalteredstateorpreparedordiluted.
CHAPTERII
Intra-Communitytrade
Article 3
Each Member State shall ensure that only semen, meeting the
followinggeneralconditions,isintendedfortrade:
(a) itmusthavebeencollected andprocessed,forthepurposeofarti-
ficalinsemination,inacollectioncentreapprovedfromthepointof1990L0429—EN—01.10.1999—002.001—3
(1) OJNoL395,31.12.1989,p.13.
(2) OJNoL194,22.7.1988,p.10.
(3) Seepage29ofthisOfficialJournal.
▼B
viewofanimalhealthforthepurposesofintra-Communitytradein
accordancewithArticle5(1);
(b) it must have been collected from domestic animals of the porcine
specieswhosehealthstatuscomplieswithAnnexB;
(c) it must have been collected, processed, stored and transported in
accordancewithAnnexesAandC.
Article 4
1. Until 31 December 1992, Member States in which all collection
centres contain only animals which have not been vaccinated againstAujeszky's disease giving a negative reaction to the serumneutraliza-tion test, or to the ELISA test for Aujeszky's disease, in accordancewiththeprovisionsofthisDirective:
— may refuse admission to their territory of semen from collection
centreswhichdonothavethatstatus,
— may not prohibit the admission of semen from boars which have
been vaccinated in the collection centre with the GI deletedvaccine,providedthat:
— such vaccination has only been carried out on boars that were
serum-negativewithregardtothevirusofAnjeszky'sdisease,
— serological examinations carried out at the earliest three weeks
after vaccination of such boars do not reveal the presence ofantibodiesinducedbythediseasevirus.
In this event a sample of semen from each daily collection
intended for trade may be subjected to a virus isolation test inanapprovedlaboratoryintheMemberStateofdestination.
Theprovisionsofthisparagraphshallnotcomeintoeffectuntil
suchtimeastheCommission,actinginaccordancewithArticle18, not later than 1 July 1991, has laid down the protocols fortheteststobeusedfortheseexaminationsfollowingtheopinion
oftheScientificVeterinaryCommittee, inparticularinconnec-
tion with the frequency of the tests to be carried out in thecentre, the virusisolation tests and the effectiveness and safetyoftheGIdeletedvaccine.
2. InaccordancewiththeprocedurereferredtoinArticle18,itmay
bedecidedtoextendtheprovisionsofparagraph1topartoftheterri-
tory of a Member State if all the collection centres in that part of the
territory contain only animals giving a negative reaction to the serumneutralizationtestortheELISAtestforAujeszky'sdisease.
3. TheCouncilshall,before31December1992,reviewthisArticle
on the basis of a report from the Commission, accompanied by anyproposals.
Article 5
1. TheMemberStateonwhoseterritorythesemencollectioncentre
issituatedshallensurethattheapprovalprovidedforinArticle3(a)is
granted only if it meets the conditions of Annex A and satisfies the
otherprovisionsofthisDirective.
TheMemberStateshallalsoensurethattheofficialveterinariansuper-
visestheobservanceofthoseprovisions.Theofficialveterinarianshallpropose that approval be withdrawn when one or more of the provi-sionsisnolongerobserved.
2. All approved semen collection centres shall be registered, each
centre being given a veterinary registration number. Each Member
State shall send a list of semen collection centres and their veterinaryregistration numbers to the other Member States and to the Commis-sionandshallnotifythemofanywithdrawalofapproval.
3. The general rules for applying this Article shall be adopted in
accordancewiththeprocedurelaiddowninArticle18.1990L0429—EN—01.10.1999—002.001—4
▼B
Article 6
1. Member States shall ensure that each consignment of semen is
accompanied by an animal health certificate drawn up in accordancewith the specimen in Annex D by an official veterinarian of theMemberStateofcollection.
Thiscertificatemust:
(a) bedrawnupinatleastoneoftheofficiallanguagesoftheMember
Stateofcollection andoneofthoseoftheMemberState ofdesti-nation;
(b) accompanytheconsignmenttoitsdestinationinitsoriginalform;
(c) bedrawnuponasinglesheetofpaper;
(d) bemadeouttoasingleconsignee.
2. The Member State of destination may, in addition to measures
provided for in Article 8 of Directive 90/425/EEC, take the necessary
measures,includingstorageinquarantine,providedthisdoesnotaffect
the viability of the semen, in order to obtain definite proof in caseswhere semen is suspected of being infected or contamined by patho-genicorganisms.
CHAPTERIII
Importsfromthirdcountries
Article 7
1. A Member State may authorize importation of semen only from
those third countries which appear on a list drawn up in accordancewith the procedure laid down in Article 19. That list may be supple-mented or amended in accordance with the procedure laid down in
Article18.
2. In deciding whether a third country may appear on the list
referredtoinparagraph1,particularaccountshallbetakenof:
(a) the state of health of the livestock, other domestic animals and
wildlife in that country, with particular reference to exotic animaldiseases,andoftheenvironmental health situationinthatcountry,whichmightendangeranimalhealthintheMemberStates;
(b) the regularity and rapidity of the information supplied by that
country concerning the existence of contagious animal diseases inits territory transmissible by semen, in particular those diseasesmentionedinlistsAandBoftheInternationalOfficeofEpizootic
Diseases;
(c) thatcountry'srulesonanimaldiseasepreventionandcontrol;
(d) the structure of the veterinary services in that country and their
powers;
(e) the organization and implementation of measures to prevent and
controlcontagiousanimaldiseases;and
(f) theguarantees whichthat country cangivewithregardtocompli-
ancewiththisDirective.
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 8
1. UndertheprocedurelaiddowninArticle19,alistshallbedrawn
up of semen collection centres from which Member States mayauthorize the importation of semen originating in third countries. The
listmaybeamendedorsupplementedaccordingtothesameprocedure.
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 services and the supervision to whichsemencollectioncentresaresubject.1990L0429—EN—01.10.1999—002.001—5
▼B
3. Asemencollectioncentremayappearonthelistprovidedforin
paragraph1onlyif:
(a) itissituatedinoneofthecountriesonthelistreferredtoinArticle
7(1);
(b) itfulfilstherequirementsofChaptersIandIIofAnnexA;
(c) ithasbeenofficiallyapprovedforexportstotheCommunitybythe
veterinaryservicesofthethirdcountryconcerned;
(d) it is placed under the supervision of a centre veterinarian of the
thirdcountryconcerned;and
(e) it is subject to inspection by an official veterinarian of the third
countryconcernedatleasttwiceayear.
Article 9
1. Semen must come from animals which, immediately prior to
collection of their semen, have remained for at least three months intheterritoryofathirdcountryonthelistreferredtoinArticle7(1).
2. WithoutprejudicetoArticle7(1)andparagraph1ofthisArticle,
Member States shall not authorize the importation of semen from athird country on the list unless the semen complies with the animalhealth requirements adopted under the procedure laid down in Article18,forimportsofsemenfromthatcountry.
In adopting the requirements referred to in the first subparagraph,
considerationshallbegivento:
(a) the health situation in the area surrounding the semen collection
centre, with particular reference to the diseases appearing on list
AoftheInternationalOfficeofEpizooticDiseases;
(b) the state of health of the herd in the semen collection centre and
testingrequirements;
(c) thestateofhealthofthedonoranimalandtestingrequirements;
(d) testingrequirementsinrelationtosemen.
3. The reference basis for fixing animal health conditions shall be
the standardslaid downinChapter IIandthe correspondingAnnexes.
It may be decided, in accordance with the procedure laid down inArticle 18, on a case-by-case basis, to waive these conditions wherethe thirdcountryconcerned providessimilar animal health guarantees,thatareatleastequivalent.
4. Article4shallapply.
Article 10
1. Member States shall authorize the importation of semen only on
submission of an animal health certificate drawn up and signed by an
officialveterinarianofthethirdcountryofcollection.
Thiscertificatemust:
(a) bedrawnupinatleastoneoftheofficiallanguagesoftheMember
State of destination and one of those of the Member State where
theimportcontrolprovidedforinArticle11iscarriedout;
(b) accompanythesementoitsdestinationinitsoriginalform;
(c) bedrawnuponasinglesheetofpaper;
(d) bemadeouttoasingleconsignee.
2. The animal health certificate must correspond to a specimen
drawnupundertheprocedurelaiddowninArticle19.
Article 11
1. Member States shall ensure that each consignment of semen
enteringthecustomsterritoryoftheCommunityissubjectedtocontrolbefore being released for free circulation or placed under a customs1990L0429—EN—01.10.1999—002.001—6
▼B
procedure and shall prohibit the introduction of the semen into the
Communityiftheimportcontrolmadeonarrivalrevealsthat:
— the semen does not come from the territory of a third country on
thelistdrawnupinaccordancewithArticle7(1),
— thesemendoesnotcomefromasemencollectioncentreonthelist
providedforinArticle8(1),
— the semen comes from the territory of a third country from which
importsareprohibitedinaccordancewithArticle15(2),
— theanimalhealthcertificatewhichaccompaniesthesemenisnotin
conformity with the conditions laid down in Article 10 and fixedpursuantthereto.
Thisparagraphshallnotapplytoconsignmentsofsemenwhicharrive
in the customs territory of the Community and are placed under a
customs transit procedure for consignment to a destination situated
outsidethesaidterritory.
However,itshallbeapplicablewherecustomstransitiswaivedduring
transportthroughtheterritoryoftheCommunity.
2. The Member State of destination may take the necessary
measures, including storage in quarantine provided that this does not
affect the viability of the semen, in order to obtain definite proof incases where semen is suspected of being infected or contamined bypathogenicorganisms.
3. If the admission of semen has been prohibited on any of the
groundsset outinparagraphs 1and2andthe exporting third country
doesnotauthorizethereturnofthesemenwithin30daysinthecaseofdeep-frozen semen, or immediately in the case of fresh semen, thecompetent veterinary authority of the Member State of destinationmayorderittobedestroyed.
Article 12
EachconsignmentofsemenauthorizedforadmissionintotheCommu-
nitybyaMemberStateonthebasisofthecontrolreferredtoinArticle11 (1) must, when sent to the territory of another Member State, beaccompanied by the original certificate or an authenticated copythereof, suitably endorsed, in either case, by the competent authority
which was responsible for the control carried out in accordance with
Article11.
Article 13
IfitisdecidedtotakedestructionmeasurespursuanttoArticle11(3),
any costs incurred shall be chargeable to the consignor, the consigneeortheiragent,withoutcompensationbytheState.
CHAPTERIV
Precautionary andcontrolmeasures
Article 14
TherulessetoutinDirective90/425/EECshallapplyinparticularwith
regard to checks at origin, the organization and the monitoring of the
checkstobecarriedoutbytheMemberStateofdestination.
Article 15
1. The precautionary measures provided for in Article 10 of Direc-
tive90/425/EECshallapplytointra-Communitytrade.
2. Without prejudice toArticles8,9and10,ifinathirdcountrya
contagiousanimaldiseasewhichcanbecarriedbysemenandisliable
toendangerthehealthofthelivestockinaMemberStatebreaksoutorspreadsorifanyotherreasonconnectedwithanimalhealthsojustifies,theMemberStateofdestinationconcernedshallprohibittheimportofthat semen, whether imported directly or indirectly through another1990L0429—EN—01.10.1999—002.001—7
▼B
MemberState,eitherfromthewholeofthethirdcountryorfrompart
ofitsterritory.
MeasurestakenbytheMemberStatesonthebasisofthefirstsubpar-
agraph and the repeal of such measures must be communicatedimmediately totheotherMemberStatesandtheCommissiontogether
withthereasonsforsuchmeasures.
Under the procedure laid down in Article 18, it may be decided that
those measures must be amended, in particular in order to coordinate
them withmeasures adopted bythe other Member States, orthat theymustberepealed.
If the situation envisaged in the first subparagraph arises and if it is
necessary that other Member States also apply the measures takenunderthatsubparagraph,amendedwherenecessaryinaccordancewiththe third subparagraph, appropriate steps shall be taken under the
procedurelaiddowninArticle18.
Resumption of imports from the third country concerned shall be
authorizedundertheprocedurelaiddowninArticle18.
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 for
ensuringuniformapplicationofthisDirective.
The country of collection within whose territory a check is being
carriedoutshallgiveallnecessaryassistancetotheexpertsincarrying
outtheirduties.TheCommissionshallinformthecountryofcollectionconcernedoftheresultsofthechecks.
The country of collection concerned shall take any measures which
may prove necessary to take account of the results of this check. Ifthecountryofcollectiondoesnottakethosemeasures,theCommissionmay,afterthesituationhasbeenexaminedbytheStandingVeterinaryCommittee, have recourse to the provisions of the third subparagraph
ofArticle6(2)andofArticle5.
2. The general provisions for implementing this Article, especially
as regards the frequency and method of carrying out the checks
referred to in the first subparagraph of paragraph 1, shall be laiddownundertheproceduresetoutinArticle19.
CHAPTERV
Finalprovisions
Article 17
The Annexes to this Directive shall be ameneded in accordance with
theprocedure setoutinArticle 18toadaptthemtoadvances intech-
nology.
Article 18
1. Where the procedure laid downinthisArticle istobe followed,
matters shall without delay be referred by the chairman, either on hisown initiative or at the request of a Member State, to the Standing
Veterinary Committee (hereinafter referred to as ‘the Committee’) set
upbyDecision68/361/EEC(
1).
2. The representative of the Commission shall submit to the
Committee a draft of the measures to be taken. The Committee shalldeliveritsopiniononthedraftwithinatimelimitwhichtheChairmanmay lay down according to the urgency of the matter. The opinionshall be delivered bythe majority laid down in Article 148 (2) of the1990L0429—EN—01.10.1999—002.001—8
(1) OJNoL255,18.10.1968,p.23.▼A1
▼A1
Treaty inthecaseofdecisionswhichtheCouncil isrequired toadopt
onaproposalfromtheCommission.Thevotesoftherepresentativesofthe Member States within the Committee shall be weighted in the
mannersetoutinthatArticle.TheChairmanshallnotvote.
►
A13.◄The Commission shall adopt the measures and apply
them immediately where they are in accordance with the Committee'sopinion. Where they are not in accordance with the Committee'sopinionorinthe absence ofanyopinion,theCommission shallforth-
with submit to the Council a proposal relating to the measures to be
taken.TheCouncilshalladoptthemeasuresbyaqualifiedmajority.
If, on the expiry of three months from the date on which the matter
was referred to it, the Council has not adopted any measures, theCommissionshalladopttheproposedmeasuresandapplythemimme-diately, savewhere the Council hasdecided against the saidmeasures
byasimplemajority.
Article 19
1. Where the procedure laid downinthisArticle istobe followed,
matters shall without delay be referred to the Committee by the
chairman, either on his own initiative or at the request of a MemberState.
2. The representative of the Commission shall submit to the
Committee a draft of the measures to be taken. The Committee shalldeliver itsopinionwithintwodays.Theopinionshallbedelivered by
the majority laid downin Article 148 (2) of the Treaty in the case of
decisionswhichtheCouncilisrequiredtoadoptonaproposalfromtheCommission. The votes of the representatives of the Member Stateswithin the Committee shall be weighted in the manner set out in thatArticle.TheChairmanshallnotvote.
►
A13.◄The Commission shall adopt the measures and apply
them immediately where they are in accordance with the Committee'sopinion. Where they are not in accordance with the Committee'sopinion,orintheabsenceofanyopinion,theCommissionshallforth-with submit to the Council a proposal relating to the measures to betaken.TheCouncilshalladoptthemeasuresbyaqualifiedmajority.
If, on the expiry of 15 days fromthe date on which the m atter was
referredtoit,theCouncilhasnotadoptedanymeasures,theCommis-
sion shall adopt the proposed measures and apply them immediately,save where the Council has decided against the said measures by asimplemajority.
Article 20
1. This Directive shall not be applicable to semen collected and
processedinaMemberStatebefore31December1991.
2. Until the date of entry into force of the decisions adopted
pursuant to Article 8, 9 and 10, Member States shall not apply to
imports of semen from third countries more favourable conditions
thanthoseresultingfromapplicationofChapterII.
Article 21
Member States shall bringinto force the laws,regulations andadmin-
istrative provisions necessary to comply with this Directive by 31December1991atthelatest.TheyshallforthwithinformtheCommis-sionthereof.
Article 22
ThisDirectiveisaddressedtotheMemberStates.1990L0429—EN—01.10.1999—002.001—9
▼B
▼A1
▼B
▼M1
ANNEX A
CHAPTERI
Conditionsfortheapprovalofsemencollection centres
Semencollectioncentresmust:1. beplacedunderthepermanentsupervisionofacentreveterinarian;
2. haveatleast:
(a) animal housing including facilities for the isolation of animals which
have failed testsdescribed inAnnexB,Chapter II,orwhichshowclin-
icalsignsofdisease,
(b) semencollectionfacilitiesincludingaseparateroomforthecleaningand
disinfectionorsterilisationofequipment,
(c) asemenprocessingroomwhichneednotnecessarybeonthesamesite,
(d) asemenstorageroomwhichneednotnecessarilybeonthesamesite;
3. besoconstructedorisolatedthatcontactwithlivestockoutsideisprevented;4. be so constructed that the animal housing and semen collection, processing
andstoragefacilitiescanbereadilycleanedanddisinfected;
5. 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
Conditionsrelatingtothesupervisionofsemencollection centres
Thecollectioncentresmust:1. besosupervisedthattheycontainonlyanimalsofthespecieswhosesemen
istobecollected;
2. besosupervisedthatarecord,fileorcomputerrecordiskeptofallporcine
animalsatthecentre,givingdetailsofthebreed,dateofbirthandidentifica-
tionofeachoftheanimals,andalsoarecord,fileorcomputerrecordofall
checks for diseasesand all vaccinations carried out, givingalso information
fromthedisease/healthfileofeachanimal;
3. be regularly inspected by an official veterinarian, at least twice a year, at
which time checks on the conditions of approval and supervision shall be
carriedout;
4. besosupervisedthattheentryofunauthorisedpersonsisprevented.Further-
more,authorisedvisitorsmustberequiredtocomplywiththeconditionslaid
downbythecentreveterinarian;
5. employtechnicallycompetentstaffsuitablytrainedindisinfectionprocedures
andhygienetechniquesrelevanttothecontrolofthespreadofdisease;
6. besosupervisedthat:
(a) only semen collected at an approved centre is processed and stored in
approved centres, without coming into contact with any other consign-
mentofsemen;
(b) collection, processing and storage of semen takes place only on the
premises set aside for the purpose and under conditions of the strictest
hygiene;
(c) all implements which come into contact with the semen or the donor
animal duringcollection andprocessingareproperlydisinfected orster-
ilisedpriortouse;
(d) products of animal origin used in the processing of semen — including
additives or a diluent — are obtained fromsources which present no
animal health risk or are so treated prior to use that such risk is
prevented;
(e) storage flasks and transport flasks are properly disinfected or sterilised
beforethebeginningofeachfillingoperation;
(f) thecryogenicagentusedhasnotbeenpreviouslyusedforotherproducts
ofanimalorigin;
(g) each collection of semen, whether or not it is separated into individual
doses,isclearly markedinsuchawaythatthedateofcollection ofthe
semen and the breed and identification of the donor animal, as well as
the name and the registration number of the centre, preceded by the
nameofthecountryoforigin,whereappropriate,intheformofacode,1990L0429—EN—01.10.1999—002.001—10
▼M1
can be readily established; the characteristics and formof this m arking
willbeestablishedundertheprocedurelaiddowninArticle19.1990L0429—EN—01.10.1999—002.001—11
▼M1
ANNEX B
CHAPTERI
Conditions applying to the admissionof animals to approved semen collec-
tioncentres
1. Allanimalsadmittedtoasemencollectioncentremust:
(a) have been subjected to a period of quarantine of at least 30 days in
accommodation specifically approved for the purpose by the competent
authority of the Member State, and where only animals having at least
thesamehealthstatusarepresent;
(b) prior to their entering the quarantine accommodation described in (a)
havebeenchosenfromherdsorholdings:
— whicharefreeofbrucellosisinaccordancewiththeArticle3.5.2.lof
theInternationalAnimalHealthCode,
— in which no animal vaccinated against foot and-mouth disease has
beenpresentinthepreceding12months,
— inwhichnoclinical,serologicalorvirologicalevidenceofAujeszky's
diseasehasbeendetectedinthepreceding12months,
— which are not situated in a restricted area defined under the provi-
sions of the Community legislation due to the emergence of a
diseaseindomesticpigs.
The animals may not previously have been kept in any herd of a lower
status
(c) before the period of quarantine specified in (a) and within the previous
30days,havebeensubjectedtothefollowingtests,performedinaccor-
dance with standards laid down in relevant Directives, with negative
results:
— a complement fixation test or a buffered brucella antigen test in
respect of brucellosis (from1 January 2001, the buffered brucella
antigentestwillbetheonlyauthorisedtest),
— a serumneutralisation or an ELISA test using all the Aujeszky's
diseaseviralantigensinthecaseofnon-vaccinatedpigs,
— or an ELISA test for Aujeszky's disease G1 antigens in the case of
pigsvaccinatedwithaG1deletedvaccine,
— anELISAtestoraserumneutralisationtestforthepresenceofclas-
sicalswinefever.
Withregardtobrucellosis,ifanimalsshouldprovepositive,animalswith
negative results in the same holding are admitted in the quarantine
accommodation after the confirmation of the brucellosis free status of
theherdsorholdingsoforiginofthepositivereactors.
The competent authority may give authorisation for the testsreferred to
in this paragraph to be carried out in the quarantine accommodation,
providedthattheresultsareknownbeforethebeginningofthe30days
quarantineperiodlaiddownin(a);
(d) during the last 15 days of the period of quarantine of at least 30 days
specifiedin(a),havebeensubjectedtothefollowingtestswithnegative
results;
— in respect of brucellosis, a complement fixation test or a buffered
brucella antigen test (fromthe l January 2001 the buffered brucella
antigentestwillbetheonlyauthorisedtest),
— a serumneutralisation or an ELISA test using all the Aujeszky's
disease viral antigens in the case of non-vaccinated pigs, or an
ELISA test for Aujeszky's disease G1 antigens in the case of pigs
vaccinatedwithaG1deletedvaccine.
Without prejudice to the provisions applicable in cases where foot-and-
mouthdiseaseorotherlistAdiseasesarediagnosed,ifanyoftheabove-
mentioned tests should prove positive, the animal must be removed
forthwithfromthequarantineaccommodation.Inthecaseofgroupquar-
antine, the competent authority must take all necessary measures to
ensurethattheremaininganimalshaveasatisfactoryhealthstatusbefore
beingadmittedtothecollectioncentreinaccordancewiththisAnnex.
However, with regard to brucellosis when animals are positive, the
followingprotocolisimplemented:
(i) thepositiveseraaresubjectedtoasero-agglutinationtestaswellas
the test mentioned at the first indent above which has not been
carriedout,1990L0429—EN—01.10.1999—002.001—12
▼M1
(ii) anepidemiologicalsurveyiscarriedoutontheholdingsoforiginof
thereactinganimals,
(iii) on the positive animals, a second series of tests (buffered brucella
antigen test, sero-agglutination, complement fixation) is carried out
onsamplescollectedmorethansevendaysafterthefirstcollection.
Thesuspicionofbrucellosiswillbeconfirmedorruledoutinthelightof
the results of the survey carried out on the holdings of origin and the
comparisonoftheresultsofthetwoseriesoftests.
When the suspicion of brucellosis is ruled out, the animals negative to
thefirstbrucellosistestcanbeintroducedintothecentre.Animalsposi-
tivetoonetestmaybeaccepted iftheyanswernegatively totwoseries
of tests (buffered brucella antigen test, sero-agglutination, complement
fixation)carriedoutwithanintervalofatleastsevendays.
2. AlltestsmustbecarriedoutinalaboratoryapprovedbytheMemberState.3. Animals may only be admitted to the semen collection centre with the
express permission of the centre veterinarian. All animal movements, both
inandout,mustberecorded.
4. No animal admitted to the semen collection centre may show any clinical
signofdiseaseonthedayofadmission;allanimalsmust,withoutprejudice
to paragraph 5, have come directly from quarantine accommodation as
referred to in paragraph 1(a) which, on the day of consignment, officially
fulfilsthefollowingconditions:
(a) it is not situated in a restricted area defined under the provisionsof the
Community legislation due to the emergence of a disease in domestic
pigs;
(b) no clinical, pathological or serological evidence of Aujeszky's disease
hasbeenrecordedforthepast12months;
5. Provided that 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 quarantine or
testingiftransferisdirect.Theanimalinquestionmustnotcomeintodirect
or indirect contact with cloven-hoofed animals of a lower health status and
themeansoftransportusedmusthavebeendisinfectedbeforeuse.
6. IncaseoftradebetweenMemberStates,animalswillbeaccompaniedbyan
animalhealthcertificateinconformitywiththemodel2inAnnexFtoDirec-
tive64/432/EEC,thedisinfectionofthemeanoftransportbeingcertified in
section C, point 4, as one of the following additional guarantee, corre-
spondingtotheirstatus:
— animals come directly from a semen collection centre complying with
Directive90/429/EEC;
— animals come directly from a quarantine accommodation and comply
withthe seen collection centre admission conditions provided in chapter
1ofAnnexBtoDirective90/429/EEC;
— animals come directly from a holding where they were undergoing the
pre-quarantineadmissionprotocolandcomplywiththequarantineadmis-
sionconditionsprovidedinChapterIpoints(1)(b)(c)and(2)ofAnnexB
toDirective90/429/EEC.
CHAPTERII
Compulsoryroutinetestsforanimalskeptatanapprovedsemencollection
centre
1. Allanimalskeptatanapprovedsemencollectioncentremustbesubjectedto
thefollowingtestswithnegativeresults:
(a) aserumneutralisation oranELISAtestusingalltheAujeszky'sdisease
viral antigens in the case of non-vaccinated pigs,or an ELISA test for
Aujeszky'sdiseaseG1antigensinthecaseofpigsvaccinatedwithaG1
deletedvaccine;
(b) in respect of brucellosis, a complement fixation test or a buffered
brucella antigen test (fromthe 1 January 2001 the buffered brucella
antigentestwillbetheonlyauthorisedtest);
(c) an ELISA test or a serumneutralisation test for the presence of antibo-
diesofclassicalswinefever.
Thesetestsshallbecarriedouteither:
on all animals when leaving the centre, but not later than l2 months after
admissionwheretheyhavenotleftthecentrebeforethistime.Thesampling
maybecarriedoutintheabattoir;1990L0429—EN—01.10.1999—002.001—13
▼M1
or
on25%oftheanimalsinthecentrearetestedeverythreemonths.In this case, the centre veterinarian shall ensure that the samples taken are
representativeofthetotalpopulationofthecentre,inparticularwithrespect
to age group and boar accommodation. Furthermore, the centre veterinarian
shallalsoensurethatallanimalsaretestedatleastonceduringtheirstayat
thecentreandatleastevery12monthsiftheirstayexceedsayear.
2. AlltestsmustbecarriedoutinalaboratoryapprovedbytheMemberState.
3. If any of the above testsshouldprove positive, the animal mustbe isolated
and the semen collected from it since the last negative test may not be the
subjectofintra-Communitytrade.
Semen collected from each animal at the centre since the date of that
animal's last negative test shall be held in separate storage and may not be
thesubjectofintra-Communitytradeuntilthehealthstatusofthecentrehas
beenre-established.1990L0429—EN—01.10.1999—002.001—14
▼M1
ANNEX C
Conditions which semen collected at approved centres must satisfy for the
purposesofintra-Communitytrade
1. Semenmustbeobtainedfromanimalswhich:
(a) shownoclinicalsignsofdiseaseonthedaythesemeniscollected;
(b) havenotbeenvaccinatedagainstfoot-and-mouthdisease;
(c) satisfytherequirementsofAnnexB,ChapterI;
(d) arenotallowedtoservenaturally;
(e) are kept in semen collection centres which must not be situated in a
restrictedareadesignatedundertheprovisionsoftheCommunitylegisla-
tionrelatingtocontagiousdiseasesindomesticpigs;
(f) have been kept in semen collection centres which, during the 30-day
period immediately prior to collection, have been free from Aujeszky's
disease.
2. Aneffective combination ofantibiotics, inparticular against leptospires and
mycoplasmas, must be added to the semen after final dilution or to the
diluant.Incaseoffrozensemen,antibioticsmustbeaddedbeforethesemen
isfrozen.
Thiscombinationmustproduceaneffect.atleastequivalenttothefollowing
dilutions:
notlessthan: 500 µgstreptomycinpermlfinaldilution
500IUpenicillinpermlfinaldilution150µglincomycinpermlfinaldilution
300µgspectinomycinpermlfinaldilution.
Immediately after the addition of the antibiotics the diluted semen must be
kept at a temperature of at least 15 ºC for a period of not less than 45
minutes.
3. Semenforintra-Communitytrademust:
(a) bestoredaslaiddowninChaptersIandIIofAnnexApriortodispatch;
(b) be transported to the Member State of destination in flasks which have
been cleaned and disinfected or sterilised before use and which have
beensealedpriortodispatchfromtheapprovedstoragefacilities.
4. MemberStatesmayrefuseadmissionofsemenfromcollectioncenterswhere
boarsvaccinatedagainstAujeszky'sdiseaseareadmitted,totheirterritoryor
to a region of their territory, when it has been recognised as free of
Aujeszky'sdiseaseinaccordanceofArticle10ofDirective64/432/EEC.1990L0429—EN—01.10.1999—002.001—15
▼B
ANNEX D
1990L0429—EN—01.10.1999—002.001—16