1990L0429 — EN — 17.12.1999 — 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
of26June1990
layingdowntheanimalhealthrequirementsapplicabletointra-Communitytradeinandimports
ofsemenofdomesticanimalsoftheporcinespecies
(90/429/EEC
(OJ L 224, 18.8.1990, p. 62)
Amended by:
Official Journal
No page date
►M1Commission Decision 1999/608/EC of 10 September 1999 L 242 20 14.9.1999
►M2Commission Decision 2000/39/EC of 16 December 1999 L 13 21 19.1.2000
Amended by:
►A1Act of Accession of Austria, Sweden and Finland C241 21 29.8.1994
(adapted by Council Decision 95/1/EC, Euratom, ECSC) L 1 1 1.1.1995
▼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
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the European Parliament(2),
Having regard to the opinion of the Economic and Social
Committee(3),
Whereas provisions relating to animal health problems in intra-
Community trade in bovine animals and swine appear in Directive 64/
432/EEC(4), as last amended by 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 swinefrom third countries;
Whereas the abovementioned provisions have ensured, with regard to
intra-Community trade and imports into the Community of bovineanimals and swine from third countries, that the country of provenanceguarantees 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 the
case of trade in semen;
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
Community of semen of porcine 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 at
approved and supervised collection centres, has been obtained from
animals whose health status is such as to ensure that the risk of spreadof animal disease is eliminated, has been collected, processed, storedand transported in accordance with rules which preserve its healthstatus and is accompanied during transport to the country of destinationby an animal health certificate in order to ensure that this obligation
has been fulfilled;
Whereas the difference in the policies pursued within the Community
with regard to vaccination against certain diseases justifies the mainte-nance of derogations, limited in time, authorizing the requirement bythe Member States, in respect of certain diseases, of additional protec-
tion against those diseases;
Whereas for imports of semen into the Community from third countries
a list of third countries should be drawn uptaking into account animalhealth criteria; whereas independently of such a list the Member Statesshould authorize importation of semen only from semen collection1990L0429 — EN — 17.12.1999 — 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 153, 6. 6. 1989, p. 29.
(6) OJ No L 302, 31. 12. 1972, p. 28.
(7) OJ No L 93, 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, in order to verify compliance with these stan-
dards, it must be possible to carry out on-the-spot checks;
Whereas the rules and procedures for checks laid down in Council
Directive 89/662/EEC of 11 December 1989 concerning veterinary
checks in intra-Community trade with a view to the completion of the
internal market(
1) should be extended to cover this Directive;
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 a Member State should be permitted to take emergency
measures in the event of an outbreak of a contagious disease in anotherMember State or in a third country; whereas the dangers associated
with such diseases and the protective measures they necessitate should
be 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 betweenthe Commission and the Member States within the Standing VeterinaryCommittee;
Whereas this Directive does not affect trade in semen produced before
the date on which the Member States must comply with it,
HAS ADOPTED THIS DIRECTIVE:
CHAPTER I
General provisions
Article 1
This Directive lays down the animal health conditions applicable to
intra-Community trade in and imports from third countries of semenof domestic animals of the porcine species.
Article 2
For the purposes of this Directive, the definitions contained in Article 2
of Directives 64/432/EEC, 72/462/EEC, 80/407/EEC(
2) and 90/425/
EEC(3) shall apply as necessary.
Moreover, ‘semen’ means the ejaculate of a domestic animal of the
porcine species, in the unaltered state or prepared or diluted.
CHAPTER II
Intra-Communitytrade
Article 3
Each Member State shall ensure that only semen, meeting the
following general conditions, is intended for trade:
(a) it must have been collected and processed, for the purpose of arti-
fical insemination, in a collection centre approved from the point of1990L0429 — EN — 17.12.1999 — 003.001 — 3
(1) OJ No L 395, 31. 12. 1989, p. 13.
(2) OJ No L 194, 22. 7. 1988, p. 10.
(3) See page 29 of this Official Journal.
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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 porcine
species whose health status complies with Annex B;
(c) it must have been collected, processed, stored and transported in
accordance with Annexes A and C.
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 serum neutraliza-tion test, or to the ELISA test for Aujeszky's disease, in accordancewith the provisions of this Directive:
— may refuse admission to their territory of semen from collection
centres which do not have that status,
— may not prohibit the admission of semen from boars which have
been vaccinated in the collection centre with the GI deletedvaccine, provided that:
— such vaccination has only been carried out on boars that were
serum-negative with regard to the virus of Anjeszky's disease,
— serological examinations carried out at the earliest three weeks
after vaccination of such boars do not reveal the presence ofantibodies induced by the disease virus.
In this event a sample of semen from each daily collection
intended for trade may be subjected to a virus isolation test inan approved laboratory in the Member State of destination.
The provisions of this paragraph shall not come into effect until
such time as the Commission, acting in accordance with Article18, not later than 1 July 1991, has laid down the protocols forthe tests to be used for these examinations following the opinion
of the Scientific Veterinary Committee, in particular in connec-
tion with the frequency of the tests to be carried out in thecentre, the virus isolation tests and the effectiveness and safetyof the GI deleted vaccine.
2. In accordance with the procedure referred to in Article 18, it may
be decided to extend the provisions of paragraph 1 to part of the terri-
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 serumneutralization test or the ELISA test for Aujeszky's disease.
3. The Council shall, before 31 December 1992, review this Article
on the basis of a report from the Commission, accompanied by anyproposals.
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) is
granted only if it meets the conditions of Annex A and satisfies the
other provisions of this Directive.
The Member State shall also ensure that the official veterinarian super-
vises the observance of those provisions. The official veterinarian shallpropose that approval be withdrawn when one or more of the provi-sions is no longer observed.
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-sion and shall notify them of any withdrawal of approval.
3. The general rules for applying this Article shall be adopted in
accordance with the procedure laid down in Article 18.1990L0429 — EN — 17.12.1999 — 003.001 — 4
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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 theMember State of collection.
This certificate must:
(a) be drawn upin 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. The Member State of destination may, in addition to measures
provided for in Article 8 of Directive 90/425/EEC, take the necessary
measures, including storage in quarantine, provided this does not affect
the viability of the semen, in order to obtain definite proof in caseswhere semen is suspected of being infected or contamined by patho-genic organisms.
CHAPTER III
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
Article 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 that country, with particular reference to exotic animaldiseases, and of the environmental health situation in that country,which might endanger animal health in the Member States;
(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 diseasesmentioned in lists A and B of the International Office of Epizootic
Diseases;
(c) that country's rules on animal disease prevention and control;
(d) the structure of the veterinary services in that country and their
powers;
(e) the organization and implementation of measures to prevent and
control contagious animal diseases; and
(f) the guarantees which that country can give with regard to compli-
ance with this Directive.
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. Under the procedure laid down in Article 19, a list shall be drawn
upof semen collection centres from which Member States mayauthorize the importation of semen originating in third countries. The
list may be amended or supplemented according to the same 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 services and the supervision to whichsemen collection centres are subject.1990L0429 — EN — 17.12.1999 — 003.001 — 5
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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
7 (1);
(b) it fulfils the requirements of Chapters I and II of Annex A;
(c) it has been officially approved for exports to the Community by the
veterinary services of the third country concerned;
(d) it is placed under the supervision of a centre veterinarian of the
third country concerned; and
(e) it is subject to inspection by an official veterinarian of the third
country concerned at least twice a year.
Article 9
1. Semen must come from animals which, immediately prior to
collection of their semen, have remained for at least three months inthe territory of a third country on the list referred to in Article 7 (1).
2. Without prejudice to Article 7 (1) and paragraph 1 of this Article,
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, for imports of semen from that country.
In adopting the requirements referred to in the first subparagraph,
consideration shall be given to:
(a) the health situation in the area surrounding the semen collection
centre, with particular reference to the diseases appearing on list
A of the International Office of Epizootic Diseases;
(b) the state of health of the herd in the semen collection centre and
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 shall be
the standards laid down in Chapter II and the corresponding Annexes.
It may be decided, in accordance with the procedure laid down inArticle 18, on a case-by-case basis, to waive these conditions wherethe third country concerned provides similar animal health guarantees,that are at least equivalent.
4. Article 4 shall apply.
Article 10
1. Member States shall authorize the importation of semen only on
submission of an animal health certificate drawn upand signed by an
official veterinarian of the third country of collection.
This certificate must:
(a) be drawn upin at least one of the official languages of the Member
State of destination and one of those of the Member State where
the import control provided for in Article 11 is carried out;
(b) accompany the semen 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. The animal health certificate must correspond to a specimen
drawn upunder the p rocedure laid down in Article 19.
Article 11
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 customs1990L0429 — EN — 17.12.1999 — 003.001 — 6
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procedure and shall prohibit the introduction of the semen into the
Community if the import control made on arrival reveals that:
— the semen does not come from the territory of a third country on
the list drawn upin accordance with Article 7 (1),
— the semen does not come from a semen collection centre on the list
provided for in Article 8 (1),
— the semen comes from the territory of a third country from which
imports are prohibited in accordance with Article 15 (2),
— the animal health certificate which accompanies the semen is not in
conformity with the conditions laid down in Article 10 and fixedpursuant 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 through the territory of the Community.
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 bypathogenic organisms.
3. If the admission of semen has been prohibited on any of the
grounds set out in paragraphs 1 and 2 and the exporting third country
does not authorize the return of the semen within 30 days in the case ofdeep-frozen semen, or immediately in the case of fresh semen, thecompetent veterinary authority of the Member State of destinationmay order it to be destroyed.
Article 12
Each consignment of semen authorized for admission into the Commu-
nity by a Member State on the basis of the control referred to in Article11 (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
Article 11.
Article 13
If it is decided to take destruction measures pursuant to Article 11 (3),
any costs incurred shall be chargeable to the consignor, the consigneeor their agent, without compensation by the State.
CHAPTER IV
Precautionary andcontrolmeasures
Article 14
The rules set out in Directive 90/425/EEC shall apply in particular with
regard to checks at origin, the organization and the monitoring of the
checks to be carried out by the Member State of destination.
Article 15
1. The precautionary measures provided for in Article 10 of Direc-
tive 90/425/EEC shall apply to intra-Community trade.
2. Without prejudice to Articles 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 import ofthat semen, whether imported directly or indirectly through another1990L0429 — EN — 17.12.1999 — 003.001 — 7
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Member State, either from the whole of the third country or from part
of its territory.
Measures taken by the Member States on the basis of the first subpar-
agraph and the repeal of such measures must be communicatedimmediately to the other Member States and the Commission together
with the reasons for such measures.
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 with measures adopted by the other Member States, or that theymust be repealed.
If the situation envisaged in the first subparagraph arises and if it is
necessary that other Member States also apply the measures takenunder that subparagraph, amended where necessary in accordance withthe third subparagraph, appropriate steps shall be taken under the
procedure laid down in Article 18.
Resumption of imports from the third country concerned shall be
authorized under the procedure laid down in Article 18.
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
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 carrying
out their duties. The Commission shall inform the country of collectionconcerned of the results of the checks.
The country of collection concerned shall take any measures which
may prove necessary to take account of the results of this check. Ifthe country of collection does not take those measures, the Commissionmay, after the situation has been examined by the Standing VeterinaryCommittee, have recourse to the provisions of the third subparagraph
of Article 6 (2) and of Article 5.
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 laiddown under the procedure set out in Article 19.
CHAPTER V
Finalprovisions
Article 17
The Annexes to this Directive shall be ameneded in accordance with
the procedure set out in Article 18 to adapt them to advances in tech-
nology.
Article 18
1. Where the procedure laid down in this Article is to be 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
upby Decision 68/361/EEC(
1).
2. The representative of the Commission shall submit to the
Committee a draft of the measures to be taken. The Committee shalldeliver its opinion on the draft within a time limit which the Chairmanmay lay down according to the urgency of the matter. The opinionshall be delivered by the majority laid down in Article 148 (2) of the1990L0429 — EN — 17.12.1999 — 003.001 — 8
(1) OJ No L 255, 18. 10. 1968, p. 23.▼A1
▼A1
Treaty in the case of decisions which the Council is required to adopt
on a proposal from the Commission. The votes of the representatives ofthe Member States within the Committee shall be weighted in the
manner set out in that Article. The Chairman shall not vote.
►
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 or in the absence of any opinion, the Commission shall forth-
with 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 months from 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 measures
by a simple majority.
Article 19
1. Where the procedure laid down in this Article is to be 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 its opinion within two days. The opinion shall be delivered by
the majority laid down in Article 148 (2) of the Treaty in the case of
decisions which the Council is required to adopt on a proposal from theCommission. The votes of the representatives of the Member Stateswithin the Committee shall be weighted in the manner set out in thatArticle. The Chairman shall not vote.
►
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, or in the absence of any opinion, the Commission shall forth-with submit to the Council a proposal relating to the measures to betaken. The Council shall adopt the measures by a qualified majority.
If, on the expiry of 15 days from 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 31 December 1991.
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
than those resulting from application of Chapter II.
Article 21
Member States shall bring into force the laws, regulations and admin-
istrative provisions necessary to comply with this Directive by 31December 1991 at the latest. They shall forthwith inform the Commis-sion thereof.
Article 22
This Directive is addressed to the Member States.1990L0429 — EN — 17.12.1999 — 003.001 — 9
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ANNEX A
CHAPTER I
Conditionsfortheapprovalofsemencollection centres
Semen collection centres must:1. be placed under the permanent supervision of a centre veterinarian;
2. have at least:
(a) animal housing including facilities for the isolation of animals which
have failed tests described in Annex B, Chapter II, or which show clin-
ical signs of disease,
(b) semen collection facilities including a separate room for the cleaning and
disinfection or sterilisation of equipment,
(c) a semen processing room which need not necessary be on the same site,
(d) a semen storage room which need not necessarily be on the same site;
3. be so constructed or isolated that contact with livestock outside is prevented;4. be so constructed that the animal housing and semen collection, processing
and storage facilities can be readily cleaned and disinfected;
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.
CHAPTER II
Conditionsrelatingtothesupervisionofsemencollection centres
The collection centres must:1. be so supervised that they contain only animals of the species whose semen
is to be collected;
2. be so supervised that a record, file or computer record is kept of all porcine
animals at the centre, giving details of the breed, date of birth and identifica-
tion of each of the animals, and also a record, file or computer record of all
checks for diseases and all vaccinations carried out, giving also information
from the disease/health file of each animal;
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
carried out;
4. be so supervised that the entry of unauthorised persons is prevented. Further-
more, authorised visitors must be required to comply with the conditions laid
down by the centre veterinarian;
5. employ technically competent staff suitably trained in disinfection procedures
and hygiene techniques relevant to the control of the spread of disease;
6. be so supervised that:
(a) 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;
(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 during collection and processing are properly disinfected or ster-
ilised prior to use;
(d) 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;
(e) storage flasks and transport flasks are properly disinfected or sterilised
before the beginning of each filling operation;
(f) the cryogenic agent used has not been previously used for other products
of animal origin;
(g) each collection of semen, whether or not it is separated into individual
doses, 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 and the registration number of the centre, preceded by the
name of the country of origin, where appropriate, in the form of a code,1990L0429 — EN — 17.12.1999 — 003.001 — 10
▼M1
can be readily established; the characteristics and form of this marking
will be established under the procedure laid down in Article 19.1990L0429 — EN — 17.12.1999 — 003.001 — 11
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ANNEX B
CHAPTER I
Conditions applying to the admissionof animals to approved semen collec-
tioncentres
1. All animals admitted to a semen collection centre must:
(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
the same health status are present;
(b) prior to their entering the quarantine accommodation described in (a)
have been chosen from herds or holdings:
— which are free of brucellosis in accordance with the Article 3.5.2.l of
the International Animal Health Code,
— in which no animal vaccinated against foot and-mouth disease has
been present in the preceding 12 months,
— in which no clinical, serological or virological evidence of Aujeszky's
disease has been detected in the preceding 12 months,
— which are not situated in a restricted area defined under the provi-
sions of the Community legislation due to the emergence of a
disease in domestic pigs.
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
30 days, have been subjected to the following tests, performed in accor-
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 (from 1 January 2001, the buffered brucella
antigen test will be the only authorised test),
— a serum neutralisation 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 vaccinated with a G1 deleted vaccine,
— an ELISA test or a serum neutralisation test for the presence of clas-
sical swine fever.
With regard to brucellosis, if animals should prove positive, animals with
negative results in the same holding are admitted in the quarantine
accommodation after the confirmation of the brucellosis free status of
the herds or holdings of origin of the positive reactors.
The competent authority may give authorisation for the tests referred to
in this paragraph to be carried out in the quarantine accommodation,
provided that the results are known before the beginning of the 30 days
quarantine period laid down in (a);
(d) during the last 15 days of the period of quarantine of at least 30 days
specified in (a), have been subjected to the following tests with negative
results;
— in respect of brucellosis, a complement fixation test or a buffered
brucella antigen test (from the l January 2001 the buffered brucella
antigen test will be the only authorised test),
— a serum neutralisation 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
vaccinated with a G1 deleted vaccine.
Without prejudice to the provisions applicable in cases where foot-and-
mouth disease or other list A diseases are diagnosed, if any of the above-
mentioned tests should prove positive, the animal must be removed
forthwith from the quarantine accommodation. In the case of groupquar-
antine, the competent authority must take all necessary measures to
ensure that the remaining animals have a satisfactory health status before
being admitted to the collection centre in accordance with this Annex.
However, with regard to brucellosis when animals are positive, the
following protocol is implemented:
(i) the positive sera are subjected to a sero-agglutination test as well as
the test mentioned at the first indent above which has not been
carried out,1990L0429 — EN — 17.12.1999 — 003.001 — 12
▼M1
(ii) an epidemiological survey is carried out on the holdings of origin of
the reacting animals,
(iii) on the positive animals, a second series of tests (buffered brucella
antigen test, sero-agglutination, complement fixation) is carried out
on samples collected more than seven days after the first collection.
The suspicion of brucellosis will be confirmed or ruled out in the light of
the results of the survey carried out on the holdings of origin and the
comparison of the results of the two series of tests.
When the suspicion of brucellosis is ruled out, the animals negative to
the first brucellosis test can be introduced into the centre. Animals posi-
tive to one test may be accepted if they answer negatively to two series
of tests (buffered brucella antigen test, sero-agglutination, complement
fixation) carried out with an interval of at least seven days.
2. All tests must be carried out in a laboratory approved by the Member State.3. Animals may only be admitted to the semen collection centre with the
express permission of the centre veterinarian. All animal 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 directly from quarantine accommodation as
referred to in paragraph 1(a) which, on the day of consignment, officially
fulfils the following conditions:
(a) it is not situated in a restricted area defined under the provisions of the
Community legislation due to the emergence of a disease in domestic
pigs;
(b)►
M2no clinical, pathological or serological evidence of Aujeszkys
disease has been recorded for the past 30 days ◄;
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
testing if transfer is direct. The animal in question must not come into direct
or indirect contact with cloven-hoofed animals of a lower health status and
the means of transport used must have been disinfected before use.
6. In case of trade between Member States, animals will be accompanied by an
animal health certificate in conformity with the model 2 in Annex F to Direc-
tive 64/432/EEC, the disinfection of the mean of transport being certified in
section C, point 4, as one of the following additional guarantee, corre-
sponding to their status:
— animals come directly from a semen collection centre complying with
Directive 90/429/EEC;
— animals come directly from a quarantine accommodation and comply
with the seen collection centre admission conditions provided in chapter
1 of Annex B to Directive 90/429/EEC;
— animals come directly from a holding where they were undergoing the
pre-quarantine admission protocol and comply with the quarantine admis-
sion conditions provided in Chapter I points (1)(b)(c) and (2) of Annex B
to Directive 90/429/EEC.
CHAPTER II
Compulsoryroutinetestsforanimalskeptatanapprovedsemencollection
centre
1. All animals kept at an approved semen collection centre must be subjected to
the following tests with negative results:
(a) a serum neutralisation 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 vaccinated with a G 1
deleted vaccine;
(b) in respect of brucellosis, a complement fixation test or a buffered
brucella antigen test (from the 1 January 2001 the buffered brucella
antigen test will be the only authorised test);
(c) an ELISA test or a serum neutralisation test for the presence of antibo-
dies of classical swine fever.
These tests shall be carried out either:
on all animals when leaving the centre, but not later than l2 months after
admission where they have not left the centre before this time. The sampling
may be carried out in the abattoir;1990L0429 — EN — 17.12.1999 — 003.001 — 13
▼M1
or
on 25 % of the animals in the centre are tested every three months.In this case, the centre veterinarian shall ensure that the samples taken are
representative of the total population of the centre, in particular with respect
to age groupand boar accommodation. Furthermore, the centre veterinarian
shall also ensure that all animals are tested at least once during their stay at
the centre and at least every 12 months if their stay exceeds a year.
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 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
the subject of intra-Community trade until the health status of the centre has
been re-established.1990L0429 — EN — 17.12.1999 — 003.001 — 14
▼M1
ANNEX C
Conditions which semen collected at approved centres must satisfy for the
purposesofintra-Communitytrade
1. Semen must be obtained from animals which:
(a) show no clinical signs of disease on the day the semen is collected;
(b) have not been vaccinated against foot-and-mouth disease;
(c) satisfy the requirements of Annex B, Chapter I;
(d) are not allowed to serve naturally;
(e) are kept in semen collection centres which must not be situated in a
restricted area designated under the provisions of the Community legisla-
tion relating to contagious diseases in domestic pigs;
(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. An effective combination of antibiotics, in particular against leptospires and
mycoplasmas, must be added to the semen after final dilution or to the
diluant. In case of frozen semen, antibiotics must be added before the semen
is frozen.
This combination must produce an effect.at least equivalent to the following
dilutions:
not less than: 500 µg streptomycin per ml final dilution
500 IU penicillin per ml final dilution150µg lincomycin per ml final dilution
300µg spectinomycin per ml final dilution.
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. Semen for intra-Community trade must:
(a) be stored as laid down in Chapters I and II of Annex A prior to dispatch;
(b) be transported to the Member State of destination in flasks which have
been cleaned and disinfected or sterilised before use and which have
been sealed prior to dispatch from the approved storage facilities.
4. Member States may refuse admission of semen from collection centers where
boars vaccinated against Aujeszky's disease are admitted, to their territory or
to a region of their territory, when it has been recognised as free of
Aujeszky's disease in accordance of Article 10 of Directive 64/432/EEC.1990L0429 — EN — 17.12.1999 — 003.001 — 15
▼B
ANNEX D
1990L0429 — EN — 17.12.1999 — 003.001 — 16