2001L0089 — EN — 01.05.2004 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCIL DIRECTIVE 2001/89/EC
of 23 October 2001
on Community measures for the control of classical swine fever
(Text with EEA relevance)
(OJ L 316, 1.12.2001, p. 5)
Amended by:
Official Journal
No page date
►A1 Act concerning the conditions of accession of the Czech Republic, the
Republic of Estonia, the Republic of Cyprus, the Republic of Latvia,
the Republic of Lithuania, the Republic of Hungary, the Republic ofMalta, the Republic of Poland, the Republic of Slovenia and the SlovakRepublic and the adjustments to the Treaties on which the EuropeanUnion is foundedL 236 33 23.9.2003
Corrected by:
►C1 Corrigendum, OJ L 168, 27.6.2002, p. 59 (2001/89/EC)
▼B
COUNCIL DIRECTIVE 2001/89/EC
of 23 October 2001
on Community measures for the control of classical swine fever
(Text with EEA relevance)
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and
in particular Article 37 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),
Having regard to the opinion of the Committee of the Regions (4),
Whereas:
(1) Council Directive 80/217/EEC of 22 January 1980 introducing
Community measures for the control of classical swine fever (5)
has been frequently and substantially amended. Now that it is tobe further amended, the Directive should, for the reasons ofclarity and rationalisation, be recast as a single text.
(2) Since live animals are listed in Annex I of the Treaty, one of theCommunity's tasks in the veterinary field is to improve the stateof health of pigs, thereby facilitating trade in pig and pigproducts to ensure the development of this sector.
(3) In the event of an outbreak of classical swine fever, it is neces-sary to establish at Community level control measures toeradicate the disease in order that the development of the pig
sector is ensured and so as to contribute to the protection of
animal health in the Community.
(4) An outbreak of classical swine fever can take on epizootic
proportions, causing mortality and disturbances on a scale which
threatens in particular the profitability of pig farming as a whole.
(5) Measures should be adopted as soon as the presence of thedisease is suspected so that immediate and effective action canbe taken as soon as its presence is confirmed, including depopu-lation of the infected holding.
(6) If an outbreak occurs it is also necessary to prevent any furtherspread of the disease by carefully monitoring movements ofanimals and the use of products liable to be contaminated,cleaning and disinfection of the infected premises, establishmentof surveillance and protection zones around the outbreak and, if
necessary, by vaccination.
(7) In case of infection, vaccinated pigs may become apparentlyhealthy virus carriers and further spread the disease. The use of
vaccines may therefore be authorised only in emergencies.
(8) In accordance with the opinion of the Scientific Committee,
marker vaccines capable of eliciting a protective immunity
distinguishable from the immune response elicited by naturalinfection with the wild virus by means of appropriate laboratorytests may become a useful additional tool in the control of clas-sical swine fever in areas with a high density of pigs, therebyavoiding massive slaughter of animals. It is therefore advisable2001L0089 — EN — 01.05.2004 — 001.001 — 2
(1) OJ C 29 E, 30.1.2001, p. 199.
(2) Opinion of the European Parliament of 14 June 2001 (not yet published in
the Official Journal).
(3) OJ C 123, 25.4.2001, p. 69.
(4) OJ C 148, 18.5.2001, p. 21.
(5) OJ L 47, 21.2.1980, p. 11. Directive as last amended by the 1994 Act of
Accession.
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to establish a Community procedure for approving such discrimi-
natory tests, once the remaining limitations of these tests havebeen overcome, and to authorise Member States to introduce
the use of marker vaccines when appropriate in an emergency.
(9) Special eradication measures should be applied in case of
disease in feral pigs.
(10) Provisions should be established to guarantee that harmonisedprocedures and methods are used for the diagnosis of classicalswine fever, including the establishment of a Community refer-ence laboratory as well as reference laboratories in the Member
States.
(11) Provisions should be established to ensure the necessary prepa-
redness to effectively tackle the emergency situations related to
one or more outbreaks of classical swine fever, in particular by
drawing up plans to combat them and setting up control centresand expert groups.
(12) Some of the measures so far adopted in the Community in the
event of an outbreak of classical swine fever in accordance
with Directive 80/217/EEC should be changed to take intoaccount scientific advances, development of new diagnostic toolsand vaccines and the experiences gained following the outbreaksof classical swine fever which recently occurred in the Commu-
nity.
(13) Experience shows that feeding catering waste to pigs can consti-
tute a risk of spreading the classical swine fever virus as a resultof lack of effectiveness of the treatment control measures.
Pending Community measures with regard to the treatment of
such waste, it is advisable to forbid from the present time itsuse for feeding to pigs. In addition, because of its particularlydangerous nature, catering waste from international means oftransport should continue to have to be destroyed.
(14) In order to ensure the continuity of the coordination of the diag-nostic work carried out under the auspices of the competentnational laboratories, the ‘Institut für Virologie der Tierärztli-chen Hochschule, Hannover’, designated by Council Decision
81/859/EEC (
1), should be confirmed as the Community refer-
ence laboratory and for reasons of legal certainty, that Decisionshould be repealed.
(15) Provision should be made for the possibility of amending, bymeans of swift procedures, this Directive and its Annexes totake account of developments in scientific and technical knowl-edge.
(16) The measures necessary for the implementation of this Directiveshould be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for theexercise of implementing powers conferred on the Commis-sion (
2).
(17) This Directive should not affect the obligations of the MemberStates concerning the deadlines for transposition of the Direc-tives set out in Part B of Annex VII,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Objectives
This Directive introduces the minimum Community measures for the
control of classical swine fever.2001L0089 — EN — 01.05.2004 — 001.001 — 3
(1) OJ L 319, 7.11.1981, p. 20. Decision as amended by Decision 87/65/EEC
(OJ L 34, 5.2.1987, p. 54).
(2) OJ L 184, 17.7.1999, p. 23.
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Article 2
Definitions
For the purposes of this Directive the following definitions shall apply:(a) ‘pig’ means any animal of the Suidae family, including feral pigs;
(b) ‘feral pig’ means a pig which is not kept or bred on a holding;
(c) ‘holding’ means any agricultural or other premises located in the
territory of a Member State, where pigs are being bred or kept ona permanent or temporary basis. This definition does not includeslaughterhouses, means of transport and fenced areas where feralpigs are kept and may be hunted; these fenced areas must be of a
size and structure that makes the measures laid down in Article
5(1) inapplicable;
(d) ‘diagnostic manual’ means the classical swine fever diagnostic
manual referred to in Article 17(3);
(e) ‘pig suspected of being infected with classical swine fever virus’
means any pig or pig carcase exhibiting clinical symptoms orshowing post-mortem lesions or reactions to laboratory testscarried out in accordance with the diagnostic manual indicatingthe possible presence of classical swine fever;
(f) ‘case of classical swine fever’ or ‘pig infected with classical swine
fever’ means any pig or pig carcase:
— in which clinical symptoms or post-mortem lesions of classical
swine fever have been officially confirmed, or
— in which the presence of the disease has been officially
confirmed as the result of a laboratory examination carried
out in accordance with the diagnostic manual;
(g) ‘outbreak of classical swine fever’ means the holding where one or
more cases of classical swine fever has or have been detected;
(h) ‘primary outbreak’ means the outbreak within the meaning of
Article 2(d) of Council Directive 82/894/EEC of 21 December
1982 on the notification of animal diseases within the Commu-nity (
1);
(i) ‘infected area’ means the area of a Member State where, following
the confirmation of one or more cases of classical swine fever in
feral pigs, disease eradication measures are in place in accordancewith Article 15 or 16;
(j) ‘primary case of classical swine fever in feral pigs’ means any
case of classical swine fever which is detected in feral pigs in an
area in which no measures are in place in accordance with Article
15 or 16;
(k) ‘meta-population of feral pigs’ means any group or subpopulation
of feral pigs with limited contacts with other groups or subpopula-tions;
(l) ‘susceptible feral pig population’ means that part of a feral pig
population which has not developed immunity against classicalswine fever virus;
(m) ‘owner’ means any person or persons, either natural or legal,
having ownership of the pigs, or charged with keeping the saidanimals, whether or not for financial reward;
(n) ‘competent authority’ means the competent authority within the
meaning of Article 2(6) of Council Directive 90/425/EEC of 26
June 1990 concerning veterinary and zootechnical checks applic-
able in intra-Community trade in certain live animals andproducts with a view to the completion of the internal market (
2);2001L0089 — EN — 01.05.2004 — 001.001 — 4
(1) OJ L 378, 31.12.1982, p. 58. Directive as last amended by Commission
Decision 2000/556/EC (OJ L 235, 19.9.2000, p. 27).
(2) OJ L 224, 18.8.1990, p. 29. Directive as last amended by Directive 92/118/
EEC (OJ L 62, 15.3.1993, p. 49).
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(o) ‘official veterinarian’ means the veterinarian designated by the
competent authority of the Member State;
(p) ‘processing’ means one of the treatments for high risk material
laid down in Article 3 of Council Directive 90/667/EEC (1),
applied in such a way as to avoid the risk of spread of classicalswine fever virus;
(q) ‘catering waste’ means any waste from food intended for human
consumption from restaurants, catering facilities or kitchens,
including industrial kitchens, and the households of the farmer or
of persons tending pigs;
(r) ‘marker vaccine’ means a vaccine that can elicit a protective
immunity distinguishable from the immune response elicited bythe natural infection with the wild type virus by means of labora-
tory tests carried out in accordance with the diagnostic manual;
(s) ‘killing’ means the killing of pigs within the meaning of Article
2(6) of Council Directive 93/119/EEC of 22 December 1993 onthe protection of animals at the time of slaughter or killing (
2);
(t) ‘slaughter’ means the slaughter of pigs within the meaning of
Article 2(7) of Directive 93/119/EEC;
(u) ‘area with a high density of pigs’ means any geographical area
with a radius of 10 km around a holding containing pigs suspectedto be or known to be infected with classical swine fever virus,where there is a pig density higher than 800 pigs per km
2; the
holding in question must be located either in a region, as defined
in Article 2(2)(p) of Council Directive 64/432/EEC (3), where there
is a density of pigs kept in holdings higher than 300 pigs per km2,
or at a distance of less than 20 km2from such a region;
(v) ‘contact holding’ means a holding where classical swine fever
could have been introduced, whether as a result of the location,movement of persons, pigs or vehicles or in any other way.
Article 3
Classical swine fever notification
1. Member States shall ensure that the presence and suspected
presence of classical swine fever are compulsorily and immediatelynotifiable to the competent authority.
2. Without prejudice to existing Community provisions on notifica-
tion of outbreaks of animal diseases, the Member State in whoseterritory classical swine fever is confirmed shall:
(a) give notification of the disease and provide information to the
Commission and the other Member States in accordance withAnnex I on:
— the outbreaks of classical swine fever which are confirmed in
holdings,
— the cases of classical swine fever which are confirmed in a
slaughterhouse or in means of transport,
— the primary cases of classical swine fever which are confirmed
in feral pigs,
— the results of the epidemiological enquiry carried out in accor-
dance with Article 8;2001L0089 — EN — 01.05.2004 — 001.001 — 5
(1) Council Directive 90/667/EEC of 27 November 1990 laying down the veter-
inary rules for the disposal and processing of animal waste, for its placing
on the market and for the prevention of pathogens in feedstuffs of animal
or fish origin and amending Directive 90/425/EEC (OJ L 363, 27.12.1990,
p. 51). Directive as last amended by the 1994 Act of Accession.
(2) OJ L 340, 31.12.1993, p. 21.
(3) Council Directive 64/432/EEC of 26 June 1964 on animal health problems
affecting intra-Community trade in bovine animals and swine (OJ L 121,
29.7.1964, p. 1977/64). Directive as last amended by Commission Decision
2001/298/EC (OJ L 102, 12.4.2001, p. 63).
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(b) provide information to the Commission and the other Member
States on the further cases confirmed in feral pigs in a classicalswine fever infected area in accordance with Article 16(3)(a) and
(4).
3. The provisions of Annex I may be supplemented or amended in
accordance with the procedure referred to in Article 26(2).
Article 4
Measures in case of suspicion of the presence of classical swine
fever in pigs on a holding
1. Where a holding contains one or more pigs suspected of being
infected with classical swine fever virus, Member States shall ensurethat the competent authority immediately sets in motion official meansof investigation to confirm or rule out the presence of the said diseasein accordance with the procedures laid down in the diagnostic manual.
When the holding is visited by an official veterinarian, a check of the
register and of the pig identification marks referred to in Articles 4 and5 of Council Directive 92/102/EEC of 27 November 1992 on the iden-tification and registration of animals (
1) shall also be carried out.
2. When the competent authority considers that the suspected
presence of classical swine fever in a holding cannot be ruled out, it
shall have the holding placed under official surveillance and shall inparticular order that:
(a) all the pigs in the various categories on the holding are to be
counted and a list compiled of the number of pigs already sick,
dead or likely to be infected in each category; the list shall be
updated to take account of pig births and deaths during the periodof suspicion; the information on the list shall be produced uponrequest and may be checked at each visit;
(b) all the pigs on the holding shall be restricted to their living quarters
or be confined in some other place where they can be isolated;
(c) no pigs may enter or leave the holding. The competent authority
may, if necessary, extend the ban on leaving the holding to cover
other species of animals and require the application of appropriatemeasures to destroy rodents or insects;
(d) no pig carcases may leave the holding without an authorisation
issued by the competent authority;
(e) no meat, pig products, semen, ova and embryos of pigs, animal
feed, utensils, materials or waste likely to transmit classical swine
fever may leave the holding without an authorisation issued by thecompetent authority; meat, pig products, semen, ova and embryosshall not be moved from the holding for intra-Community trade;
(f) the movement of persons to or from the holding shall be subject to
written authorisation by the competent authority;
(g) the movement of vehicles to or from the holding shall be subject to
written authorisation by the competent authority;
(h) appropriate means of disinfection shall be used at the entrances and
exits of buildings housing pigs and of the holding itself; any person
entering or leaving pig holdings shall fulfil appropriate hygienic
measures necessary to reduce the risk of spread of classical swinefever virus. Furthermore, all means of transport shall be carefullydisinfected before leaving the holding;
(i) an epidemiological enquiry shall be carried out in accordance with
Article 8.2001L0089 — EN — 01.05.2004 — 001.001 — 6
(1) OJ L 355, 5.12.1992, p. 32. Directive as amended by the 1994 Act of
Accession.
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3. Where required by the epidemiological situation and in particular
if the holding containing suspected pigs is located in an area with ahigh density of pigs, the competent authority:
(a) may apply the measures of Article 5(1) in the holding referred to in
paragraph 2 of this Article; however, the competent authority may,where it considers that conditions permit, limit the application of
these measures only to the pigs suspected of being infected or
contaminated with classical swine fever virus and the part of theholding where they were kept, provided that these pigs have beenhoused, kept and fed completely separately from the other pigs inthe holding. In any case, a sufficient number of samples shall be
taken from the pigs when they are killed in order that the presence
of classical swine fever virus can be confirmed or ruled out, inaccordance with the diagnostic manual;
(b) may establish a temporary control zone around the holding referred
to in paragraph 2; some or all the measures referred to in paragraph1 or 2 shall be applied in the pig holdings within this zone.
4. The measures provided for in paragraph 2 shall not be lifted until
the suspicion of classical swine fever has been officially ruled out.
Article 5
Measures in case of confirmation of the presence of classical swine
fever in pigs on a holding
1. In cases where the presence of classical swine fever is officially
confirmed in a holding, Member States shall ensure that, in addition tothe measures referred to in Article 4(2), the competent authorityprescribes that:
(a) all pigs on the holding are to be killed without delay under official
supervision and in such a way as to avoid the risk of spread ofclassical swine fever virus during transport or killing;
(b) a sufficient number of samples are to be taken, in accordance with
the diagnostic manual, from the pigs when they are killed in order
that the manner of introduction of classical swine fever virus into
the holding and the length of time during which it may haveexisted on the holding before the disease was notified may beestablished;
(c) the carcases of pigs which have died or have been killed are to be
processed under official supervision;
(d) meat of pigs slaughtered during the period between the probable
introduction of disease to the holding and the taking of official
measures shall wherever possible be traced and processed under
official supervision;
(e) semen, ova and embryos of pigs collected from the holding during
the period between the probable introduction of disease into theholding and the taking of official measures shall be traced anddestroyed under official supervision in such a way as to avoid the
risk of spread of classical swine fever virus;
(f) all substances and waste likely to be contaminated, such as
feedingstuff, must be subjected to a treatment ensuring the destruc-tion of classical swine fever virus; all single-use materials whichmay be contaminated, in particular those used for slaughter opera-tions, should be destroyed; these rules shall be applied inaccordance with the instructions of the official veterinarian;
(g) after the pigs have been disposed of, the buildings used for housing
the pigs, the vehicles used for transporting them or their carcases
and the equipment, bedding, manure and slurry likely to becontaminated shall be cleaned and disinfected or treated in accor-dance with Article 12;
(h) in the case of a primary outbreak of disease, the classical swine
fever virus isolate shall be subject to the laboratory procedure laiddown in the diagnostic manual to identify the genetic type;2001L0089 — EN — 01.05.2004 — 001.001 — 7
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(i) an epidemiological enquiry shall be carried out in accordance with
Article 8.
2. In cases where an outbreak has been confirmed in a laboratory, a
zoo, a wildlife park or a fenced area where pigs are kept for scientific
purposes or purposes related to conservation of species or conservationof rare breeds, the Member State concerned may decide to derogatefrom paragraph 1(a) and (e), provided that basic Community interestsare not endangered.
This decision shall immediately be notified to the Commission.
The Commission shall in all cases immediately review the situation
with the Member State concerned and in the Standing VeterinaryCommittee at the earliest possible opportunity. If necessary, measuresto prevent the spreading of the disease shall be adopted in accordancewith the procedure referred to in Article 27(2), which may includeemergency vaccination in accordance with the procedure laid down to
in Article 19.
Article 6
Measures in the event of confirmation of the presence of classical
swine fever in holdings consisting of different production units
1. In the case of confirmation of the presence of classical swine
fever in holdings which consist of two or more separate productionunits and in order that fattening of pigs may be completed, the compe-
tent authority may decide to derogate from the provisions of Article
5(1)(a) as regards healthy pig production units on a holding which isinfected provided that the official veterinarian has confirmed that thestructure, size and distance between these production units and theoperations carried out there are such that the production units provide
completely separate facilities for housing, keeping and feeding, so that
the virus cannot spread from one production unit to another.
2. If use is made of the derogation referred to in paragraph 1, the
Member States shall draw up detailed rules for applying it in the lightof the animal health guarantees which can be given.
3. Member States which make use of this derogation shall immedi-
ately notify the Commission thereof. The Commission shall in all cases
immediately review the situation with the Member State concerned and
in the Standing Veterinary Committee at the earliest possible opportu-nity. If necessary, measures to prevent the spreading of the diseaseshall be adopted in accordance with the procedure laid down in Article27(2).
Article 7
Measures in contact holdings
1. Holdings shall be recognised as contact holdings where the offi-
cial veterinarian finds, or considers on the basis of the epidemiologicalenquiry carried out in accordance with Article 8, that classical swinefever may have been introduced, either from other holdings to theholding referred to in Article 4 or Article 5, or from the holdingreferred to in Article 4 or Article 5 to other holdings.
The provisions of Article 4 shall be applied in such holdings until the
suspicion of classical swine fever has been officially ruled out.
2. The competent authority shall apply the measures provided for in
Article 5(1) in the contact holdings referred to in paragraph 1 of thisArticle if the epidemiological situation so requires.
A sufficient number of samples shall be taken in accordance with the
diagnostic manual from the pigs when they are killed in order that the
presence of classical swine fever virus in these holdings can beconfirmed or ruled out.
3. The main criteria and risk factors to be considered for the appli-
cation of the measures provided for in Article 5(1)(a) in contactholdings are laid down in Annex V. These criteria and risk factors2001L0089 — EN — 01.05.2004 — 001.001 — 8
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may subsequently be amended or supplemented to take account of
scientific developments and experiences, in accordance with the proce-dure referred to in Article 26(2).
Article 8
Epidemiological enquiry
Member States shall ensure that the epidemiological enquiry in relation
to suspected cases or outbreaks of classical swine fever is carried outon the basis of questionnaires, prepared within the framework of the
contingency plans referred to in Article 22.
Such enquiry shall deal at least with:(a) the length of time during which classical swine fever virus may
have existed on the holding before the disease was notified orsuspected;
(b) the possible origin of classical swine fever on the holding and the
identification of other holdings in which pigs may have becomeinfected or contaminated from the same source;
(c) the movement of persons, vehicles, pigs, carcases, semen, meat or
any material which could have transported the virus to or from theholdings in question.
If the results of this enquiry suggest that classical swine fever may
have spread from or to holdings located in other Member States, the
Commission and the Member States concerned shall be immediatelyinformed.
Article 9
Establishment of protection and surveillance zones
1. Immediately after the diagnosis of classical swine fever has been
officially confirmed in pigs on a holding, the competent authority shall
establish a protection zone with a radius of at least 3 kilometres aroundthe outbreak site, which shall itself be included in a surveillance zoneof a radius of at least 10 kilometres.
The measures referred to in Articles 10 and 11 shall be applied in the
respective zones.
2. When establishing zones, the competent authority must take
account of:
(a) the results of the epidemiological enquiry carried out in accordance
with Article 8;
(b) the geographical situation, particularly natural or artificial bound-
aries;
(c) the location and proximity of holdings;
(d) patterns of movements and trade in pigs and the availability of
slaughterhouses;
(e) the facilities and personnel available to control any movement of
pigs within the zones, in particular if the pigs to be killed have to
be moved away from their holding of origin.
3. If a zone includes parts of the territory of several Member States,
the competent authorities of the Member States concerned shall colla-borate to establish the zone.
4. The competent authority shall take all necessary measures,
including the use of prominent signs and warning notices and use of
media resources, such as the press and television, to ensure that all
persons in the protection and surveillance zones are fully aware of therestrictions in force in accordance with Articles 10 and 11, and shalltake such measures as they consider appropriate to ensure the adequateenforcement of these measures.2001L0089 — EN — 01.05.2004 — 001.001 — 9
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Article 10
Measures in the established protection zone
1. Member States shall ensure that the following measures are
applied in the protection zone:
(a) a census of all the holdings shall be made as soon as possible; after
the establishment of the protection zone these holdings shall be
visited by an official veterinarian within not more than seven daysfor a clinical examination of the pigs and for a check of the registerand of the pig identification marks referred to in Articles 4 and 5 ofDirective 92/102/EEC;
(b) the movement and transport of pigs on public or private roads,
excluding when necessary the service roads of holdings, shall be
prohibited unless approved by the competent authority to allowthe movements referred to in point (f). This prohibition need notbe applied to the transit of pigs by road or rail without unloadingor stopping. Furthermore, in accordance with the procedure referredto in Article 27(2), a derogation may be granted for slaughter pigs
coming from outside the protection zone and on their way to a
slaughterhouse situated in the said zone for immediate slaughter;
(c) trucks and other vehicles and equipment, which are used to trans-
port pigs or other livestock or material which may be contaminated(e.g. carcases, feedingstuff, manure, slurry, etc.) shall be cleaned,disinfected and treated as soon as possible after contamination, in
accordance with the provisions and procedures laid down in Article
12. No truck or vehicle, which has been used in the transport ofpigs may leave the zone without being cleaned and disinfectedand then inspected and authorised by the competent authority;
(d) no other domestic animal may enter or leave a holding without the
authorisation of the competent authority;
(e) all dead or diseased pigs on a holding shall be immediately notified
to the competent authority, which shall carry out appropriate inves-tigations in accordance with the procedures laid down in thediagnostic manual;
(f) pigs may not be removed from the holding in which they are kept
for at least 30 days after the completion of the preliminary cleaning
and disinfection of the infected holdings. After 30 days, subject to
the conditions set out in paragraph 3, the competent authority mayauthorise the removal of pigs from the said holding to be directlytransported to:
— a slaughterhouse designated by the competent authority, prefer-
ably within the protection or surveillance zone for the purposeof immediate slaughter,
— a processing plant or a suitable place where the pigs are imme-
diately killed and their carcases are processed under officialsupervision, or
— under exceptional circumstances, to other premises located
within the protection zone. Member States availing themselvesof this provision shall immediately inform the Commissionthereof in the Standing Veterinary Committee;
(g) semen, ova and embryos of pigs shall not leave the holdings situ-
ated within the protection zone;
(h) any person entering or leaving pig holdings shall observe appro-
priate hygienic measures necessary to reduce the risk of spread ofclassical swine fever virus.
2. Where the prohibitions provided for in paragraph 1 are main-
tained beyond 30 days because of further outbreaks of the disease andas a result animal welfare or other problems arise in keeping the pigs,subject to the conditions set out in paragraph 3, the competent authoritymay, following a reasoned application by the owner, authorise removal2001L0089 — EN — 01.05.2004 — 001.001 — 10
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of pigs from a holding within the protection zone, to be directly trans-
ported to:
(a) a slaughterhouse designated by the competent authority, preferably
within the protection or surveillance zone for the purpose ofimmediate slaughter;
(b) a processing plant or a suitable place where the pigs are immedi-
ately killed and their carcases are processed under official
supervision; or
(c) under exceptional circumstances, to other premises located within
the protection zone. Member States availing themselves of this
provision shall immediately inform the Commission thereof in theStanding Veterinary Committee.
3. When reference is made to this paragraph, the competent
authority may authorise removal of pigs from the holding concerned,on condition that:
(a) a clinical examination of the pigs in the holding and in particular
those to be moved, including the taking of the body temperatureof a proportion thereof, and a check of the register and the pigidentification marks referred to in Articles 4 and 5 of Directive92/102/EEC have been carried out by an official veterinarian;
(b) the checks and examinations above have shown no evidence of
classical swine fever and compliance with the provisions of Direc-tive 92/102/EEC;
(c) the pigs are transported in vehicles sealed by the competent
authority;
(d) the vehicle and equipment which have been involved in the trans-
port of the pigs are immediately cleaned and disinfected after thetransport in accordance with the provisions referred to in Article12;
(e) if the pigs are to be slaughtered or killed, a sufficient number of
samples shall be taken from the pigs in accordance with the diag-nostic manual in order that the presence of classical swine fevervirus in these holdings can be confirmed or ruled out;
(f) if the pigs are to be transported to a slaughterhouse:
— the competent authority responsible for the slaughterhouse shall
be informed of the intention to send pigs to it and notifies thedispatching competent authority of their arrival,
— on arrival at the slaughterhouse these pigs shall be kept and
slaughtered separately from other pigs,
— during ante and post-mortem inspection carried out at the desig-
nated slaughterhouse, the competent authority shall take intoaccount any signs relating to the presence of classical swine
fever,
— the fresh meat from these pigs shall be either processed or
marked with the special stamp referred to in Article 5a ofCouncil Directive 72/461/EEC (
1) and subsequently treated in
accordance with the rules laid down in Article 4(1) of CouncilDirective 80/215/EEC (
2). This shall be done at an establish-
ment designated by the competent authority. The meat shall be
sent to the said establishment on condition that the consignment
is sealed before departure and remains sealed throughout thetransport.2001L0089 — EN — 01.05.2004 — 001.001 — 11
(1) Council Directive 72/461/EEC of 12 December 1972 on health problems
affecting intra-Community trade in fresh meat (OJ L 302, 31.12.1972, p.
24). Directive as last amended by the 1994 Act of Accession.
(2) Council Directive 80/215/EEC of 22 January 1980 on animal health
problems affecting intra-Community trade in meat products (OJ L 47,
21.2.1980, p. 4). Directive as last amended by the 1994 Act of Accession.
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4. The measures in the protection zone shall continue to be applied
at least until:
(a) cleaning and disinfection in the infected holdings have been carried
out;
(b) pigs on all holdings have undergone clinical and laboratory exam-
inations carried out in accordance with the diagnostic manual inorder to detect the possible presence of classical swine fever virus.
The examinations referred to in point (b) shall not take place before 30
days have elapsed after the completion of preliminary cleaning anddisinfection measures on the infected holdings.
Article 11
Measures in the established surveillance zone
1. Member States shall ensure that the following measures are
applied in the surveillance zone:
(a) a census shall be taken of all pig holdings;
(b) the movement and transport of pigs on public or private roads,
excluding when necessary the service roads of holdings, shall beprohibited, unless approved by the competent authority. This prohi-bition need not be applied to the transit of pigs by road or rail,without unloading or stopping, and to slaughter pigs coming fromoutside the surveillance zone and on their way to a slaughterhouse
situated in the said zone for immediate slaughter;
(c) trucks and other vehicles and equipment which are used to trans-
port pigs or other livestock or material which may becontaminated (e.g. carcases, feedingstuff, manure, slurry, etc.) shallbe cleaned, disinfected and treated as soon as possible aftercontamination, in accordance with the provisions and procedureslaid down in Article 12. No truck or vehicle which has been used
in the transport of pigs may leave the zone without having been
cleaned and disinfected;
(d) no other domestic animal may enter or leave a holding during the
first seven days after establishment of the zone without the author-isation of the competent authority;
(e) all dead or diseased pigs on a holding shall be immediately notified
to the competent authority, which shall carry out appropriate inves-tigations in accordance with the procedures laid down in the
diagnostic manual;
(f) pigs may not be removed from the holding in which they are kept
for at least 21 days after the completion of the preliminary cleaningand disinfection of the infected holdings. After 21 days, subject tothe conditions set out in Article 10(3), the competent authority mayauthorise the removal of the pigs from the said holding to bedirectly transported to:
— a slaughterhouse designated by the competent authority, prefer-
ably within the protection or surveillance zone for the purpose
of immediate slaughter,
— a processing plant or a suitable place where the pigs are imme-
diately killed and their carcases are processed under official
supervision, or
— under exceptional circumstances, to other premises located
within the protection or surveillance zone. Member Statesavailing themselves of this provision shall immediately informthe Commission thereof in the Standing Veterinary Committee.
However, if the pigs are to be transported to a slaughterhouse, at
the request of a Member State, accompanied by appropriate justifi-
cation, and in accordance with the procedure referred to in Article27(2), derogations to the provisions laid down in Article 10(3)(e)and (f), fourth indent, may be authorised, in particular with respectto the marking of meat of these pigs and its subsequent use, and thedestination of the treated products;2001L0089 — EN — 01.05.2004 — 001.001 — 12
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(g) semen, ova and embryos of pigs shall not leave the holdings situ-
ated within the surveillance zone;
(h) any person entering or leaving pig holdings shall observe appro-
priate hygienic measures necessary to reduce the risk of spread of
classical swine fever virus.
2. Where the prohibitions provided for in paragraph 1 are main-
tained beyond 30 days because of further outbreaks of the disease and
where as a result animal welfare or other problems arise in keeping the
pigs, subject to the conditions set out in Article 10(3), the competentauthority may, following a reasoned application by the owner,authorise removal of pigs from a holding within the surveillance zoneto be directly transported to:
(a) a slaughterhouse designated by the competent authority, preferably
within the protection or surveillance zone for the purpose ofimmediate slaughter;
(b) a processing plant or a suitable place where the pigs are immedi-
ately killed and their carcases are processed under official
supervision; or
(c) under exceptional circumstances, to other premises located within
the protection or surveillance zone. Member States availing them-selves of this provision shall immediately inform the Commissionthereof in the Standing Veterinary Committee.
3. The measures in the surveillance zone shall continue to be
applied at least until:
(a) cleaning and disinfection in the infected holdings have been carried
out;
(b) pigs on all holdings have undergone clinical and, where necessary,
laboratory examinations as laid down in the diagnostic manual inorder to detect the possible presence of classical swine fever virus.
The examinations referred to in point (b) shall not take place before 20
days have elapsed after the completion of preliminary cleaning anddisinfection measures on the infected holdings.
Article 12
Cleaning and disinfection
1. Member States shall ensure that:
(a) the disinfectants to be used and their concentrations are officially
approved by the competent authority;
(b) the cleaning and disinfection operations are carried out under offi-
cial supervision in accordance with:
— the instructions given by the official veterinarian, and
— the principles and procedures for cleaning, disinfecting and
treatment laid down in Annex II.
2. The principles and procedures for cleaning and disinfecting laid
down in Annex II may subsequently be amended or supplemented totake account of scientific developments and experiences, in accordance
with the procedure referred to in Article 26(2).
Article 13
Repopulation of pig holdings following disease outbreaks
1. The reintroduction of pigs to the holding referred to in Article 5
shall not take place until at least 30 days after completion of the
cleaning and disinfection operations in accordance with Article 12.
2. The reintroduction of pigs shall take account of the type of
farming practised on the holding concerned and must conform to the
following procedures:
(a) as regards open-air pig holdings, the reintroduction of pigs shall
start with the introduction of sentinel pigs which have been2001L0089 — EN — 01.05.2004 — 001.001 — 13
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checked and found negative for the presence of antibodies against
classical swine fever virus or come from holdings not subjected toany restrictions related to classical swine fever. The sentinel pigs
shall be placed, in accordance with the requirements of the compe-
tent authority, throughout the infected holding and be sampled 40days after having been placed on the holding, and tested for thepresence of antibodies, in accordance with the diagnostic manual.
If none of the pigs has developed antibodies against classical swine
fever virus, full repopulation may take place. No pig may leave theholding before the negative results of the serological examinationare available;
(b) as regards all other forms of rearing, the reintroduction of pigs
shall either take place in accordance with the measures providedfor in point (a) or shall be based on total repopulation, providedthat:
— all the pigs arrive within a period of 20 days and come from
holdings not subjected to any restrictions related to classicalswine fever,
— pigs in the repopulated herd are subjected to a serological
examination in accordance with the diagnostic manual.Sampling for that examination shall be carried out at the earliest
40 days after the arrival of the last pigs,
— no pig may leave the holding before the negative results of the
serological examination are available.
3. However, if more than six months have elapsed from the comple-
tion of the cleaning and disinfection operations in the holding, thecompetent authority may authorise a derogation from the provisionslaid down in paragraph 2 above, taking into account the epidemiolo-gical situation.
Article 14
Measures in case of suspicion and confirmation of the presence of
classical swine fever in pigs in a slaughterhouse or means of trans-
port
1. Where there is a suspicion of the presence of classical swine
fever in a slaughterhouse or means of transport, Member States shallensure that the competent authority immediately sets in motion officialmeans of investigation to confirm or rule out the presence of the said
disease in accordance with the procedures laid down in the diagnostic
manual.
2. Should a case of classical swine fever be detected in a slaughter-
house or means of transport, the competent authority shall ensure that:
(a) all susceptible animals in the slaughterhouse or in the means of
transport are killed without delay;
(b) the carcases, offal and animal waste of possibly infected and
contaminated animals are processed under official supervision;
(c) cleaning and disinfection of buildings and equipment, including
vehicles, takes place under the supervision of the official veteri-narian in accordance with Article 12;
(d) an epidemiological inquiry is carried out as provided in Article 8
mutatis mutandis ;
(e) the classical swine fever virus isolate is subject to the laboratory
procedure laid down in the diagnostic manual to identify thegenetic type of virus;
(f) the measures referred to in Article 7 are applied in the holding
where the infected pigs or carcases came from and in the othercontact holdings. Unless otherwise indicated by the epidemiologicalinquiry, the measures laid down in Article 5(1) shall be applied in
the holding of origin of the infected pigs or carcases;
(g) no animals are reintroduced for slaughter or transport until at least
24 hours after completion of the cleaning and disinfection opera-tions completed out in accordance with Article 12.2001L0089 — EN — 01.05.2004 — 001.001 — 14
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Article 15
Measures in case of suspicion and confirmation of the presence of
classical swine fever in feral pigs
1. Immediately after the competent authority of a Member State has
information that feral pigs are suspected of being infected, it shall takeall appropriate measures to confirm or rule out the presence of thedisease, by giving information to the owners of pigs and to hunters,and by investigations of all feral pigs shot or found dead, includinglaboratory testing.
2. As soon as confirmation of a primary case of classical swine
fever in feral pigs has taken place, in order to reduce the spread ofdisease the competent authority of a Member State shall immediately:
(a) establish an expert group including veterinarians, hunters, wildlife
biologists and epidemiologists. The expert group shall assist thecompetent authority in:
— studying the epidemiological situation and defining an infected
area, in accordance with the provisions laid down in Article
16(3)(b),
— establishing appropriate measures to be applied in the infected
area in addition to the ones referred to in points (b) and (c);
these measures may include suspension of hunting and a ban
in feeding feral pigs,
— drawing up the eradication plan to be submitted to the Commis-
sion in accordance with Article 16,
— carrying out audits to verify the effectiveness of the measures
adopted to eradicate classical swine fever from the infectedarea;
(b) immediately place under official surveillance pig holdings in the
defined infected area and shall in particular order that:
— an official census be carried out of all categories of pigs on all
holdings; the census shall be kept up to date by the owner. The
information in the census shall be produced on request and may
be checked at each inspection. However, as regards open-air pigholdings, the first census carried out may be done on the basisof an estimate,
— all pigs on the holding be kept in their living quarters or some
other place where they can be isolated from feral pigs. The feralpigs must not have access to any material which may subse-quently come in contact with the pigs on the holding,
— no pigs enter or leave the holding save where authorised by the
competent authority having regard to the epidemiological situa-
tion,
— appropriate means of disinfection be used at the entrance and
exits of buildings housing pigs and of the holding itself,
— appropriate hygienic measures be applied by all persons coming
in contact with feral pigs, to reduce the risk of spread of clas-sical swine fever virus, which measures may include atemporary ban on persons having been in contact with feral
pigs from entering a pig holding,
— all dead or diseased pigs with classical swine fever symptoms
on a holding be tested for the presence of classical swine fever,
— no part of any feral pig, whether shot or found dead, as well as
any material or equipment which could be contaminated withclassical swine fever virus shall be brought into a pig holding,
— pigs, their semen, embryos or ova shall not be moved from the
infected area for the purpose of intra-Community trade;2001L0089 — EN — 01.05.2004 — 001.001 — 15
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(c) arrange that all feral pigs shot or found dead in the defined infected
area are inspected by an official veterinarian and examined forclassical swine fever in accordance with the diagnostic manual.
Carcases of all animals found positive shall be processed under
official supervision. Where such testing proves negative as regardsclassical swine fever, Member States shall apply the measures laiddown in Article 11(2) of Council Directive 92/45/EEC (
1). Parts not
intended for human consumption shall be processed under official
supervision;
(d) ensure that the classical swine fever virus isolate is subject to the
laboratory procedure indicated in the diagnostic manual to identify
the genetic type of virus.
3. If a case of classical swine fever has occurred in feral pigs in an
area of a Member State close to the territory of another Member State,the Member States concerned shall collaborate in the establishment ofdisease control measures.
Article 16
Plans for the eradication of classical swine fever from a feral pig
population
1. Without prejudice to the measures laid down in Article 15,
Member States shall submit to the Commission within 90 days fromthe confirmation of the primary case of classical swine fever in feral
pigs a written plan of the measures taken to eradicate the disease in
the area defined as infected and of the measures applied on the hold-ings in that area.
The Commission shall examine the plan in order to determine whether
it permits the desired objective to be attained. The plan, if necessarywith amendments, shall be approved in accordance with the procedure
referred to in Article 27(2).
The plan may subsequently be amended or supplemented to take
account of developments in the situation.
If these amendments concern the redefinition of the infected area,
Member States shall ensure that the Commission and the other Member
States are informed of these amendments without delay.
If the amendments concern other provisions of the plan, Member States
shall submit the amended plan to the Commission for examination andpossible approval in accordance with the procedure referred to inArticle 27(2).
2. After the measures provided for in the plan mentioned in para-
graph 1 have been approved, they shall replace the initial measureslaid down in Article 15, on a date which shall be decided upon whenapproval is given.
3. The plan mentioned in paragraph 1 shall contain information on:
(a) the results of the epidemiological investigations and controls
carried out in accordance with Article 15 and the geographicaldistribution of the disease;
(b) a defined infected area within the territory of the Member State
concerned. When defining the infected area, the competentauthority shall take into account:
— the results of the epidemiological investigations carried out and
the geographical distribution of the disease,
— the feral pig population in the area,— the existence of major natural or artificial obstacles to move-
ments of feral pigs;2001L0089 — EN — 01.05.2004 — 001.001 — 16
(1) Council Directive 92/45/EEC of 16 June 1992 on public health and animal
health problems relating to the killing of wild game and the placing on the
market of wild-game meat (OJ L 268, 14.9.1992, p. 35). Directive as last
amended by Directive 97/79/EC (OJ L 24, 30.1.1998, p. 31).
▼B
(c) the organisation of close cooperation between biologists, hunters,
hunting organisations, the wildlife protection services and veter-inary services (animal health and public health);
(d) the information campaign to be enforced to increase hunters'
awareness of the measures they have to adopt in the frameworkof the eradication plan;
(e) specific efforts made to determine the number and location of feral
pig meta-populations in and around the infected area;
(f) the approximate number of meta-populations of feral pigs and
their size in and around the infected area;
(g) specific efforts made to determine the extent of the infection in the
feral pig population, by investigation of feral pigs shot by huntersor found dead, and by laboratory testing, including age-stratified
epidemiological investigations;
(h) the measures adopted to reduce spread of disease due to feral pig
movements and/or contact between meta-populations of feral pigs;these measures may include a prohibition of hunting;
(i) the measures adopted to reduce the susceptible feral pig population
and in particular young piglets;
(j) the requirements to be complied with by hunters in order to avoid
any spread of the disease;
(k) the method of removal of feral pigs found dead or shot, which
shall be based on:
— processing under official supervision, or
— inspection by an official veterinarian and laboratory tests as
provided for in the diagnostic manual. Carcases of all animals
found positive shall be processed under official supervision.
Where such testing proves negative as regards classical swinefever, Member States shall apply the measures laid down inArticle 11(2) of Directive 92/45/EEC. Parts not intended forhuman consumption shall be processed under official supervi-sion;
(l) the epidemiological enquiry which is carried out on each feral pig,
whether shot or found dead. This enquiry must include thecompletion of a questionnaire which supplies information about:
— the geographical area where the animal was found dead or
shot,
— the date on which the animal was found dead or shot,— the person who found or shot the animal,
— the age and sex of the pig,
— if shot: symptoms before shooting,
— if found dead: the state of the carcase,
— laboratory findings;
(m) surveillance programmes and prevention measures applicable to
the holdings situated in the defined infected area, and if necessary,
in its surroundings, including the transport and movement of
animals within, from and to the area; these measures shall at leastinclude the ban of moving pigs, their semen, embryos or ova fromthe infected area for the purposes of intra-Community trade;
(n) other criteria to be applied for lifting the measures taken to eradi-
cate the disease in the defined area and the measures applied to
holdings in the area;
(o) the authority charged with supervising and coordinating the depart-
ments responsible for implementing the plan;
(p) the system established in order that the expert group appointed in
accordance with Article 15(2)(a) can review on a regular basis the
results of the eradication plan;
(q) the disease monitoring measures that shall be enforced after a
period of at least 12 months has elapsed from the last confirmedcase of classical swine fever in feral pigs in the defined infectedarea; these monitoring measures shall stay in place for at least 122001L0089 — EN — 01.05.2004 — 001.001 — 17
▼B
months and shall at least include the measures already enforced in
accordance with points (g), (k) and (l).
4. A report concerning the epidemiological situation in the defined
area and the results of the eradication plan shall be transmitted to theCommission and to the other Member States every 6 months.
More detailed rules relating to the information that is to be provided by
the Member States on this matter may be adopted in accordance with
the procedure referred to in Article 26(2).
Article 17
Diagnostic procedures and bio-safety requirements
1. Member States shall ensure that:(a) diagnostic procedures, sampling and laboratory testing to detect the
presence of classical swine fever are carried out in accordance with
the diagnostic manual;
(b) a national laboratory is responsible for coordinating standards and
methods of diagnosis in each Member State in accordance with
the provisions of Annex III.
2. The national laboratories referred to in paragraph 1(b) shall liaise
with the Community reference laboratory as mentioned in Annex IV.Without prejudice to the provisions of Decision 90/424/EEC, and in
particular Article 28 thereof, the powers and duties of the laboratory
shall be those appearing in the said Annex.
3. In order to ensure uniform procedures to diagnose classical swine
fever, within two months from the date when this Directive enters intoforce and in accordance with the procedure referred to in Article 26(2),
a classical swine fever diagnostic manual shall be approved, estab-
lishing at least:
(a) minimum bio-safety requirements and quality standards to be
observed by the classical swine fever diagnostic laboratories andfor the transport of samples;
(b) criteria and procedures to be followed when clinical or post-
mortem examinations are carried out to confirm or exclude thepresence of classical swine fever;
(c) criteria and procedures to be followed for collection of samples
from live pigs or their carcases, to confirm or exclude classicalswine fever by laboratory examinations, including sampling
methods for serological or virological screenings carried out in the
framework of the application of the measures provided for in thisDirective;
(d) laboratory tests to be used for the diagnosis of classical swine
fever, including:
— tests for the differential diagnosis between classical swine fever
virus and other pestiviruses
— if available and suitable, tests to distinguish the antibody pattern
elicited by a marker vaccine from the one elicited by the wildtype of classical swine fever virus,
— criteria for the evaluation of the results of the laboratory tests;
(e) laboratory techniques for the genetic typing of classical swine fever
virus isolates.
4. In order that appropriate bio-safety conditions are guaranteed to
protect animal health, the classical swine fever virus, its genome andantigens and vaccines for research, diagnosis or manufacture shall be
manipulated or used only in places, establishments or laboratories
approved by the competent authority.
The list of approved places, establishments or laboratories shall be
transmitted to the Commission ►
C1 before 1 May 2003 ◄and kept
updated hereafter.2001L0089 — EN — 01.05.2004 — 001.001 — 18
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5. The provisions of Annexes III and IV and the diagnostic manual
may be supplemented or amended in accordance with the procedurereferred to in Article 26(2).
Article 18
Use, manufacture and sale of classical swine fever vaccines
1. Member States shall ensure that:
(a) the use of classical swine fever vaccines is prohibited;
(b) the manipulation, manufacture, storage, supply, distribution and
sale of classical swine fever vaccines in the territory of theCommunity are carried out under official supervision.
2. If necessary, rules relating to the production, packaging, distribu-
tion and state of the stocks of classical swine fever vaccines in theCommunity may be adopted in accordance with the procedure referredto in Article 26(2).
Article 19
Emergency vaccination in pig holdings
1. Notwithstanding Article 18(1)(a), when classical swine fever has
been confirmed in pig holdings and the epidemiological data availablesuggest that it threatens to spread, emergency vaccination may be intro-duced in pig holdings in accordance with the procedures and provisionslaid down in paragraphs 2 to 9 of this Article.
2. Without prejudice to the provisions of Article 5(2), the main
criteria and risk factors to be considered for the application of emer-gency vaccination are laid down in Annex VI. These criteria and risk
factors may subsequently be amended or supplemented to take account
of scientific developments and experiences, in accordance with theprocedure referred to in Article 26(2).
3. Where a Member State intends to introduce vaccination, it shall
submit to the Commission an emergency vaccination plan, which shallat least include information on:
(a) the disease situation which has led to the request for emergency
vaccination;
(b) the extent of the geographical area in which emergency vaccination
is to be carried out and the number of pig holdings in this area;
(c) categories of pigs and the approximate number of pigs to be vacci-
nated;
(d) the vaccine to be used;(e) the duration of the vaccination campaign;(f) the identification and registration of the vaccinated animals;
(g) measures for the movement of pigs and their products;
(h) the criteria that will be considered to decide if vaccination or the
measures referred to in Article 7(2) will be applied in contact hold-ings;
(i) other matters appropriate to the emergency, including the clinical
and laboratory examinations to be carried out on samples taken in
the vaccinated holdings and in the other holdings located in the
vaccination area, in particular if a marker vaccine is to be used.
The Commission shall immediately examine the plan in collaboration
with the Member State concerned. In accordance with the procedurereferred to in Article 27(2), the emergency vaccination plan may beapproved or amendments and additions may be requested beforeapproval is given.
In accordance with the procedure referred to in Article 27(2), the emer-
gency vaccination plan may subsequently be amended or supplementedto take account of developments in the situation.2001L0089 — EN — 01.05.2004 — 001.001 — 19
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4. Without prejudice to Articles 10 and 11, any Member State which
carries out emergency vaccination shall ensure that during the vaccina-tion period:
(a) no live pigs leave the vaccination area, unless to be transported to a
slaughterhouse designated by the competent authority and situatedwithin the vaccination area or close to that area for immediateslaughter or to a rendering plant or to a suitable place where theyare immediately killed and their carcases are processed under offi-
cial supervision;
(b) all fresh pig meat produced from pigs vaccinated during the emer-
gency vaccination is either processed or marked and treated inaccordance with the provisions referred to in Article 10(3)(f),
fourth indent;
(c) semen, ova and embryos collected from the pigs to be vaccinated
during the 30 days prior to vaccination are traced and destroyed
under official supervision.
5. The provisions laid down in paragraph 4 shall apply for a
minimum of 6 months following completion of the vaccination opera-tions in the area in question.
6. In accordance with the procedure referred to in Article 27(2) and
before the end of the six-month period referred to in paragraph 5,
measures shall be taken to ban:
(a) seropositive pigs from leaving the holding where they are kept,
except for immediate slaughter;
(b) the collection of semen, embryos or ova from seropositive pigs;
(c) piglets of seropositive sows from leaving their holding of origin
unless being transported to:
— a slaughterhouse for immediate slaughter,
— a holding designated by the competent authority, from which
they are to be sent directly to the slaughterhouse,
— a holding after obtaining a negative result from a serological
test for antibodies against the classical swine fever virus.
7. By way of derogation from paragraph 3, the decision to introduce
emergency vaccination may be taken by a Member State provided thatCommunity interests are not jeopardised and that the following condi-
tions are met:
(a) an outline emergency vaccination plan must be drawn up in accor-
dance with Article 22. The specific plan and the decision to adoptemergency vaccination must be notified to the Commission beforethe start of the vaccination operations;
(b) in addition to the information referred to in paragraph 3, the plan
must prescribe that all the pigs in the holdings where the vaccineis to be used will be slaughtered or killed as quickly as possibleafter completion of the vaccination operations in accordance withparagraph 4(a), and the fresh meat produced from these pigs will
be either processed or marked and treated in accordance with the
provisions laid down in Article 10(3)(f), fourth indent.
When this decision is taken, the vaccination plan shall be immediately
reviewed in the Standing Veterinary Committee. In accordance with theprocedure referred to in Article 27(2), the plan may be approved or
amendments and additions may be requested before approval is given.
8. Notwithstanding the provisions laid down in paragraphs 5 and 6,
the measures provided for in paragraph 4 may be lifted after:
(a) all the pigs in the holdings where vaccine has been used have been
slaughtered or killed in accordance with paragraph 4(a), and thefresh meat produced from these pigs has been either processed or
marked and treated in accordance with Article 10(3)(f), fourth
indent;
(b) all the holdings where vaccinated pigs had been kept have been
cleansed and disinfected in accordance with Article 12.2001L0089 — EN — 01.05.2004 — 001.001 — 20
▼B
Where the measures provided for in paragraph 4 are lifted, Member
States shall also ensure that:
(a) reintroduction of pigs in the holdings above shall not take place
until at least 10 days after completion of the cleaning and disinfec-tion operations, and after all pigs in the holdings where vaccine hasbeen applied have been slaughtered or killed;
(b) after reintroduction, pigs on all holdings in the vaccination area
shall undergo clinical and laboratory examinations as laid down inthe diagnostic manual in order to detect the possible presence ofclassical swine fever virus. In case of pigs reintroduced in holdingswhere the vaccine had been applied, these examinations shall not
take place until at least 40 days have elapsed after the reintroduc-
tion, during which time pigs shall not be allowed to move from theholding.
9. In those cases where a marker vaccine has been used during the
vaccination campaign, derogations from the provisions referred to in
paragraphs 4, 5 and 6 may be authorised in accordance with the proce-
dure referred to in Article 27(2), in particular with respect to themarking of meat of the vaccinated pigs and its subsequent use, andthe destination of the treated products. Such authorisation shall besubject to the following conditions:
(a) the vaccination plan shall have been approved before the starting of
the vaccination operations in accordance with paragraph 3,
(b) a specific request shall have been submitted to the Commission by
the Member State concerned, accompanied by a comprehensive
report on the implementation of the vaccination campaign, itsresults and the overall epidemiological situation, and
(c) an on-the-spot check on the implementation of the vaccination
campaign shall have been carried out in accordance with the proce-dures referred to in Article 21.
The adoption of derogations from the provisions referred to in para-
graphs 4, 5 and 6 shall be based on the risk that classical swine fever
virus is spread by movements or trade of the vaccinated pigs, their
offspring or their products.
Article 20
Emergency vaccination of feral pigs
1. Notwithstanding Article 18(1)(a), when classical swine fever has
been confirmed in feral pigs and the epidemiological data available
suggest that it threatens to spread, emergency vaccination of feral pigsmay be introduced in accordance with the procedures and provisionslaid down in paragraphs 2 and 3.
2. Where a Member State intends to introduce vaccination, it shall
submit to the Commission an emergency vaccination plan, which shall
include information on:
(a) the disease situation which has led to the request for emergency
vaccination;
(b) the extent of the geographical area in which emergency vaccination
is to be carried out. In any case, this area shall be part of theinfected area defined in accordance with Article 16(3)(b);
(c) the type of vaccine to be used and the procedure of vaccination;(d) the special efforts to be carried out to vaccinate the young;
(e) the expected duration of the vaccination campaign;
(f) the approximate number of feral pigs to be vaccinated;
(g) the measures adopted to avoid a high turn-over of the feral pig
population;
(h) the measures adopted to avoid any spread of vaccine virus to pigs
kept in holdings, if applicable;2001L0089 — EN — 01.05.2004 — 001.001 — 21
▼B
(i) the expected results of the vaccination campaign and the para-
meters that will be considered to verify its effectiveness;
(j) the authority charged with supervising and coordinating the depart-
ments responsible for implementing the plan;
(k) the system established in order that the expert group appointed in
accordance with Article 15(2)(a) can review on regular basis theresults of the vaccination campaign;
(l) other matters appropriate to the emergency.
The Commission shall immediately examine the plan in collaboration
with the Member State concerned, in particular to ensure its consis-
tency with the measures applied in accordance with the eradicationplan provided for in Article 16(1).
If the vaccination area is close to the territory of another Member State
where measures to eradicate classical swine fever from feral pigs arealso in place, consistency between the vaccination plan and themeasures applied in such other Member State shall also be ensured.
In accordance with the procedure referred to in Article 27(2), the emer-
gency vaccination plan may be approved or amendments and additions
may be requested before approval is given.
In accordance with the procedure above, the emergency vaccination
plan may subsequently be amended or supplemented to take account
of developments in the situation.
3. A report concerning the results of the vaccination campaign shall
be transmitted by the Member State concerned to the Commission andthe other Member States every 6 months, together with the reportreferred to in Article 16(4).
Article 21
Community controls
Experts from the Commission may make on-the-spot checks in coop-
eration with the competent authorities of the Member States, in so far
as it is necessary to ensure uniform application of this Directive. TheMember State on whose territory checks are made shall provide theexperts with all the assistance necessary for carrying out their duties.The Commission shall inform the competent authority of the results of
the checks made.
The rules of application of this Article and in particular those
governing the procedure for cooperation with the national authorities
shall be adopted in accordance with the procedure referred to in Article26(2).
Article 22
Contingency plans
1. Each Member State shall draw up a contingency plan specifying
the national measures to be implemented in the event of an outbreak of
classical swine fever.
This plan shall allow access to facilities, equipment, personnel and all
other appropriate materials necessary for the rapid and efficient eradi-
cation of the outbreak. It shall give a precise indication of:
(a) the vaccine requirements which each Member State concerned
considers it needs in the event of emergency vaccination;
(b) the regions where areas with a high density of pigs may be found
in each Member State, in order that in these regions a higher levelof disease awareness and preparedness is ensured.
2. The criteria and requirements to be applied for drawing up the
contingency plan shall be those laid down in Annex VII.
In accordance with the procedure referred to in Article 26(2), those
criteria and requirements may be amended or supplemented taking2001L0089 — EN — 01.05.2004 — 001.001 — 22
▼B
into account the specific nature of classical swine fever and progress
made in the development of disease control measures.
3. The Commission shall examine the plans in order to determine
whether they permit the desired objective to be attained and shall
suggest to the Member State concerned any amendments required, inparticular to ensure that they are compatible with those of the otherMember States.
The plans, if necessary amended, shall be approved in accordance with
the procedure referred to in Article 26(2).
The plans may subsequently be amended or supplemented, in accor-
dance with the procedure referred to in Article 26(2), to take into
account developments in the situation. In any case, every five yearseach Member State shall update the plan and submit it to the Commis-sion for approval in accordance with the procedure referred to inArticle 26(2).
Article 23
Disease control centres and expert groups
1. Member States shall ensure that a fully functional national disease
control centre can be immediately established in the event of classical
swine fever outbreaks.
2. The national disease control centre shall direct and monitor the
operations of the local disease control centres referred to in paragraph3. It shall be responsible for, inter alia :
(a) defining the necessary control measures;
(b) ensuring the prompt and efficient implementation of the measures
referred to above by the local disease control centres;
(c) deploying staff and other resources to local disease control centres;
(d) providing information to the Commission, to other Member States,
the national veterinary organisations, national authorities and theagricultural and trading bodies;
(e) when indicated, organising an emergency vaccination and defining
vaccination zones;
(f) liaising with diagnostic laboratories;(g) liaising with the press and other media;
(h) liaising with the police authorities to ensure specific legal
measures.
3. Member States shall ensure that fully functional local disease
control centres can be established immediately in the event of classicalswine fever outbreaks.
4. Certain functions of the national disease control centre may,
however, be delegated to the local disease control centre interveningat the administrative level provided for in Article 2(2)(p) of Directive64/432/EEC or at a higher level, provided that that does not compro-mise the objectives of the national disease control centre.
5. Member States shall create a permanently operational expert
group to maintain expertise in order to assist the competent authority
in ensuring disease preparedness.
In case of an outbreak the expert group shall assist the competent
authority at least in:
(a) the epidemiological enquiry;
(b) sampling, testing and interpretation of results of laboratory tests;
(c) establishment of disease control measures.
6. Member States shall ensure that the national and local disease
control centres and the expert group have staff, facilities and equipmentincluding communication systems as necessary, and a clear and effec-tive chain of command and management to ensure the prompt2001L0089 — EN — 01.05.2004 — 001.001 — 23
▼B
implementation of the disease control measures laid down in this
Directive.
Details about staff, facilities, equipment, chain of command and
management of the national and local disease control centres and ofthe expert group shall be laid down in the contingency plans referredto in Article 22.
7. Further criteria and requirements about the function and duties of
the national disease control centres, local disease control centres and
expert groups may be laid down in accordance with the procedureprovided for in Article 26(2).
Article 24
Use of catering waste
1. The Member States shall ensure that:
(a) the feeding of catering waste to pigs is prohibited;
(b) catering waste from international means of transport such as ships,
land vehicles and aircraft is collected and destroyed under officialsupervision;
(c) the information on the application of the provisions of points (a)
and (b) and the relevant checks carried out by Member States istransmitted to the Commission by 31 October each year at thelatest, and for the first time in 2003. The Commission shall submitthis information to the Standing Veterinary Committee set up by
Council Decision 68/361/EEC (
1).
2. Detailed rules for the control measures to be applied and the
information to be supplied by Member States in this connection, inparticular as regards the provisions of paragraph 1(c) may be adoptedin accordance with the procedure laid down in Article 26(2).
3. The provisions laid down in paragraphs 1 and 2 shall apply until
the date of application of Community legislation on the use of cateringwaste for feeding to pigs in the framework of the rules on animal by-products not intended for human consumption or on animal nutrition.
Article 25
Procedures for amending this Directive and its Annexes and for the
adoption of further detailed rules for the implementation of this
Directive
1. This Directive may if necessary be amended by the Council,
acting by a qualified majority on a proposal from the Commission, to
take account of developments in scientific and technical knowledge.
2. However, the Annexes to this Directive shall be amended in
accordance with the procedure laid down in Article 26(2).
3. Any detailed rules necessary for the implementation of this Direc-
tive may be adopted in accordance with the procedure laid down in
Article 26(2).
Article 26
Normal regulatory procedure
1. The Commission shall be assisted by the Standing Veterinary
Committee established by Decision 68/361/EEC.
2. Where reference is made to this paragraph, Articles 5 and 7 of
Decision 1999/468/EC shall apply.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be
set at three months.2001L0089 — EN — 01.05.2004 — 001.001 — 24
(1) OJ L 255, 18.10.1968, p. 23.
▼B
Article 27
Accelerated regulatory procedure
1. The Commission shall be assisted by the Standing Veterinary
Committee established by Decision 68/361/EEC.
2. Where reference is made to this paragraph, Articles 5 and 7 of
Decision 1999/468/EC shall apply.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be
set at 15 days.
Article 28
Repeals
1. Directive 80/217/EEC, as amended by the acts ►C1 listed in
Annex VIII, Part A, are hereby repealed as from 1 November2002, ◄subject to the transitional provisions laid down in Article 29
and without prejudice to the obligation of the Member Statesconcerning the deadlines for transposition of the said Directives set
out in ►
C1 Annex VIII, Part B. ◄
References to the repealed Directive 80/217/EEC shall be construed as
references to this Directive and shall be read in accordance with
►C1 the correlation table set out in Annex IX. ◄
2. Decision 81/859/EEC is hereby repealed.
Article 29
Transitional provisions
1. By way of derogation from the first subparagraph of Article
28(1), Annexes I and IV to Directive 80/217/EEC shall continue to
apply for the purposes of this Directive pending the entry into forceof the Decision approving the diagnostic manual referred to in Article17(3) of this Directive.
2. Plans to eradicate classical swine fever from feral pigs, approved
in accordance with Article 6a of Directive 80/217/EEC and in place atthe date of entry into force of this Directive, shall continue to apply forthe purposes of this Directive.
However, Member States shall, ►
C1 before 1 February 2003, ◄
submit to the Commission amendments to these plans, taking into
account the provisions of Article 16(3).
The plans, amended as necessary, shall be approved in accordance with
the procedure referred to in Article 27(2).
3. Contingency plans for the control of classical swine fever,
approved in accordance with Article 14b of Directive 80/217/EEC and
in place at the date of entry into force of this Directive, shall continue
to apply for the purposes of this Directive.
However, Member States shall, ►C1 before 1 May 2003, ◄ submit
to the Commission amendments to these plans, taking into account the
provisions laid down in Article 22.
The plans, amended as necessary, shall be approved in accordance with
the procedure referred to in Article 26(2).
4. Pending the application of this Directive, further transitional
provisions on the control of classical swine fever may be adopted in
accordance with Article 26(2).
Article 30
Transposition into national legislation and application
Member States shall bring into force the laws, regulations and admin-
istrative provisions necessary to comply with this Directive by 31October 2002 at the latest. They shall forthwith inform the Commissionthereof.2001L0089 — EN — 01.05.2004 — 001.001 — 25
▼B
They shall apply these provisions from 1 November 2002.
When Member States adopt these measures, they shall contain a refer-
ence to this Directive or be accompanied by such reference on the
occasion of their official publication. The methods of making such a
reference shall be laid down by the Member States.
Article 31
Entry into force
This Directive shall enter into force on the day of its publication in the
Official Journal of the European Communities .
Article 32
Addressees
This Directive is addressed to the Member States.2001L0089 — EN — 01.05.2004 — 001.001 — 26
▼B
ANNEX I
Notification of disease and further epidemiological information to be
provided by the Member State where classical swine fever has been
confirmed
1. Within 24 hours from the confirmation of each primary outbreak, primary
case in feral pigs or case in a slaughterhouse or means of transport, the
Member State concerned must notify by means of the Animal Disease Noti-
fication System established in accordance with Article 5 of Council Directive
82/894/EEC:
(a) the date of dispatch;
(b) the time of dispatch;
(c) the name of the Member State;
(d) the name of the disease;(e) the number of outbreaks or cases;(f) the date on which classical swine fever was suspected;
(g) the date of confirmation;
(h) the methods used for confirmation;(i) whether the presence of the disease has been confirmed in feral pigs or in
pigs in a holding, slaughterhouse or means of transport;
(j) the geographical location where the outbreak or the case of classical
swine fever has been confirmed;
(k) the disease control measures applied.
2. In case of primary outbreaks or cases in slaughterhouses or means of trans-
port, in addition to the data referred to in point 1, the Member State
concerned must also forward the following information:
(a) the number of susceptible pigs in the outbreak, slaughterhouse or means
of transport;
(b) the number of dead pigs of each category on the holding, slaughterhouse
or means of transport;
(c) for each category, the morbidity of the disease and the number of pigs in
which classical swine fever has been confirmed;
(d) the number of pigs killed in the outbreak, slaughterhouse or means of
transport;
(e) the number of carcases processed;
(f) in case of an outbreak, its distance from the nearest pig holding;
(g) if classical swine fever was confirmed in a slaughterhouse or means of
transport, the location of the holding or holdings of origin of the infected
pigs or carcases.
3. In case of secondary outbreaks, the information referred to in points 1 and 2
must be forwarded within the time limit laid down in Article 4 of Council
Directive 82/894/EEC.
4. The Member State concerned shall ensure that the information to be provided
in relation to any outbreak or case of classical swine fever in a holding,
slaughterhouse or means of transport in accordance with points 1, 2 and 3 is
followed as soon as possible by a written report to the Commission and the
other Member States including at least:
(a) the date on which the pigs on the holding, slaughterhouse or means of
transport were killed and their carcases processed;
(b) the results of the tests carried out on samples taken when pigs were
killed;
(c) where the derogation provided for in Article 6(1) has been applied, the
number of pigs killed and processed and the number of pigs which are
to be slaughtered at a later date and the time limit laid down for their
slaughter;
(d) any information relating to the possible origin of the disease or the origin
of the disease if this has been ascertained;
(e) in the case of a primary outbreak or a case of classical swine fever in a
slaughterhouse or means of transport, the genetic type of virus respon-
sible for the outbreak or the case;2001L0089 — EN — 01.05.2004 — 001.001 — 27
▼B
(f) in cases where pigs have been killed in contact holdings or in holdings
containing pigs suspected of being infected with classical swine fever
virus, information on:
— the date of killing and the number of pigs of each category killed in
each holding,
— the epidemiological link between the outbreak or case of classical
swine fever and each contact holding or the reasons that have
induced suspicion of classical swine fever in each suspected holding,
— the results of the laboratory tests carried out on the samples taken
from the pigs in the holdings and when they were killed.
In cases where pigs in contact holdings were not killed, information must
be provided on the reasons for this decision.2001L0089 — EN — 01.05.2004 — 001.001 — 28
▼B
ANNEX II
Principles and procedures for cleansing and disinfection
1. General principles and procedures:
(a) the cleansing and disinfection operations and where necessary the
measures to destroy rodents and insects are carried out under official
supervision and in accordance with the instructions given by the official
veterinarian;
(b) the disinfectants to be used and their concentrations are officially
approved by the competent authority to ensure destruction of classical
swine fever virus;
(c) the activity of disinfectants is to be checked before use, as activity of
certain disinfectants is diminished by prolonged storage;
(d) the choice of disinfectants and of procedures for disinfection is to be
made taking into account the nature of the premises, vehicles and objects
which are to be treated;
(e) the conditions under which degreasing agents and disinfectants are used
must ensure that their efficacy is not impaired. In particular technical
parameters provided by the manufacturer, such as pressure, minimum
temperature and required contact time, are to be observed;
(f) irrespective of the disinfectant used, the following general rules are to
apply:
— thorough soaking of bedding and litter as well as faecal matter with
the disinfectant,
— washing and cleaning by careful brushing and scrubbing of the
ground, floors, ramps and walls after the removal or dismantling,
where possible, of equipment or installations so as to avoid impairing
the cleansing and disinfection procedures,
— then, further application of disinfectant for a minimum contact time
as stipulated in the manufacturer's recommendations,
— the water used for cleaning operations is to be disposed of in such a
way as to avoid any risk of spreading the virus and in accordance
with the instructions of the official veterinarian;
(g) where washing is carried out with liquids applied under pressure, re-
contamination of the previously cleansed parts is to be avoided;
(h) washing, disinfecting or destroying of equipment, installations, articles or
compartments likely to be contaminated is to be carried out;
(i) following the disinfection procedures, re-contamination is to be avoided;(j) cleansing and disinfection required in the framework of this Directive is
to be documented in the holding or vehicle register and, where official
approval is required, be certified by the supervising official veterinarian.
2. Special provisions on cleansing and disinfection of infected holdings:
(a) preliminary cleansing and disinfection:
— during the killing of the animals all necessary measures are to be
taken to avoid or minimise the dispersion of classical swine fever
virus. This is to include inter alia the installation of temporary disin-
fection equipment, supply of protective clothing, showers,
decontamination of used equipment, instruments and facilities and
the interruption of power supply to the ventilation,
— carcases of killed animals are to be sprayed with disinfectant,
— if the carcases must be removed from the holding for processing,
covered and leak proof containers are to be used,
— as soon as the carcases of the pigs have been removed for processing,
those parts of the holding in which these animals were housed and
any parts of other buildings, yards, etc. contaminated during killing,
slaughter or post-mortem examination are to be sprayed with disin-
fectants approved for use in accordance with Article 12,
— any tissue or blood which may have been spilled during slaughter or
post-mortem or gross contamination of buildings, yards, utensils, etc.,
is to be carefully collected and processed with the carcases,
— the disinfectant used is to remain on the treated surface for at least 24
hours;
(b) final cleansing and disinfection:
— manure and used bedding are to be removed and treated in accor-
dance with point (3)(a),2001L0089 — EN — 01.05.2004 — 001.001 — 29
▼B
— grease and dirt are to be removed from all surfaces by the application
of a degreasing agent and the surfaces washed with water,
— after washing with water, further spraying with disinfectant is to be
carried out,
— after seven days the premises are to be treated with a degreasing
agent, rinsed with water, sprayed with disinfectant and rinsed again
with water.
3. Disinfection of contaminated bedding, manure and slurry:
(a) manure and used bedding are to be stacked to heat, sprayed with disin-
fectant and left for at least 42 days or destroyed by burning or burying;
(b) slurry is to be stored for at least 42 days after the last addition of infec-
tive material, unless the competent authorities authorise a reduced
storage period for slurry which was actually treated in accordance with
the instructions given by the official veterinarian so as to ensure the
destruction of the virus.
4. However, by way of derogation from points 1 and 2, in case of open-air
holdings, the competent authority may establish specific procedures for
cleaning and disinfection, taking into account the type of holding and the
climatic conditions.2001L0089 — EN — 01.05.2004 — 001.001 — 30
▼B
ANNEX III
List and duties of national classical swine fever laboratories
1. The national classical swine fever laboratories are as follows:
Belgium
Centre d'etude et de recherche vétérinaires et agrochimiques, 1180 Bruxelles
Czech Republic
Státní veterinární ústav Jihlava, Rantí řovská 93, 586 05 Jihlava
Denmark
Statens Veterinære Institut for Virusforskning, Lindholm, 4771 Kalvehave
Germany
Bundesforschungsanstalt für Viruskrankheiten der Tiere, 17498 Insel Riems
Estonia
Veterinaar- ja Toidulaboratoorium, Kreutzwaldi 30, 51006 Tartu
Greece
Veterinary Institute of Infectious and Parasitic Diseases, 15310 Ag. Paraskevi
Spain
Centro de Investigación en Sanidad Animal, 28130 Valdeolmos (Madrid)
France
AFSSA-Ploufragan, Zoopole des Côtes d'Armor, 22440 Ploufragan
Ireland
Veterinary Research Laboratory, Abbotstown, Castleknock, Dublin 15
Italy
Istituto Zooprofilattico Sperimentale dell'Umbria e delle Marche, 06100
Perugia
Cyprus
Institut für Virologie, Tierarztschule Hannover, Bunteweg 17, D-30559
Hannover
Latvia
Valsts veterin ārmedic īnas diagnostikas centrs, Lejupes iela 3, LV-1076 R īga
Lithuania
Nacionalin ėveterinarijos laboratorija, J. Kairi ūkščio g. 10, LT-2021 Vilnius
Luxembourg
Laboratoire de Médicine Vétérinare de l'Etat, 1020 Luxembourg
Hungary
Országos Állategészségügyi Intézet (OÁI), Pf. 2., Tábornok u. 2., HU-1581
Budapest
Malta
Veterinary Laboratory Agency, Weybridge, United Kingdom
The Netherlands
Instituut voor Veehouderij en Diergezondheid (ID-Lelystad), 8200 AB
Lelystad
Austria
Bundesanstalt für Vet. Med. Untersuchungen in Modling, Robert Koch-Gasse
17, 2340 Modling2001L0089 — EN — 01.05.2004 — 001.001 — 31
▼A1
▼B
▼A1
▼B
▼A1
▼B
▼A1
▼B
▼A1
Poland
Laboratorium Zakładu Chorób ŚwińPaństwowego Instytutu Weterynaryj-
nego, Al. Partyzantów 57, PL-24-100 Puławy
Portugal
Laboratório Nacional de Investigação Veterinária, 1500 Lisboa
Slovenia
Nacionalni veterinarski inštitut, Gerbi čeva 60, SI-1000 Ljubljana
Slovakia
Štátny veterinary ústav, Pod dráhami 918, SK-960 86 Zvolen
Finland
Eläinlääkintä—ja elintarviketutkimuslaitos, 00231 Helsinki/Anstalten för
veterinärmedicin och livsmedel, 00231 Helsingfors
Sweden
Statens veterinärmedicinska anstalt, 75189 Uppsala
United Kingdom
Veterinary Laboratories Agency, New Haw, Weybridge, Surrey KT153NB
2. The national classical swine fever laboratories are responsible for ensuring
that in each Member State the laboratory testing to detect the presence of
classical swine fever and the identification of the genetic type of virus
isolates are carried out in accordance with the diagnostic manual. To this
end they may make special agreements with the Community reference
laboratory or with other national laboratories.
3. The national classical swine fever laboratory in each Member State is respon-
sible for coordinating the standards and diagnostic methods in each classical
swine fever diagnostic laboratory within the Member State. To this end:
(a) they may provide diagnostic reagents to individual laboratories;
(b) they are to control the quality of all diagnostic reagents used in that
Member State;
(c) they are to arrange comparative tests periodically;
(d) they are to hold isolates of classical swine fever virus from cases and
outbreaks confirmed in that Member State.2001L0089 — EN — 01.05.2004 — 001.001 — 32
▼B
▼A1
▼B
▼B
ANNEX IV
Community reference laboratory for classical swine fever
1. The Community reference laboratory for classical swine fever is: Institut für
Virologie, der Tierärztlichen Hochschule Hannover, Bünteweg 17, D-30559
Hannover, Germany.
2. The functions and duties of the Community reference laboratory for classical
swine fever are:
(a) to coordinate, in consultation with the Commission, the methods
employed in the Member States for diagnosing classical swine fever,
specifically by:
— storing and supplying cell cultures for use in diagnosis,
— typing, storing and supplying strains of classical swine fever virus for
serological tests and the preparation of antisera,
— supplying standardised sera, conjugate sera and other reference
reagents to the national laboratories in order to standardise the tests
and reagents employed in the Member States,
— building up and holding a classical swine fever virus collection,— organising periodic comparative tests of diagnostic procedures at
Community level,
— collecting and collating data and information on the methods of diag-
nosis used and the results of tests carried out,
— characterising isolates of the virus by the most up-to-date methods
available to allow greater understanding of the epizootiology of clas-
sical swine fever,
— keeping abreast of developments in classical swine fever surveillance,
epizootiology and prevention throughout the world,
— retaining expertise on the virus causing classical swine fever and
other pertinent viruses to enable rapid differential diagnosis,
— acquiring a thorough knowledge of the preparation and use of the
products of veterinary immunology used to eradicate and control
classical swine fever;
(b) to make the necessary arrangements for training or re-training experts in
laboratory diagnosis with a view to harmonising diagnostic techniques;
(c) to have trained personnel available for emergency situations occurring
within the Community;
(d) to perform research activities and whenever possible coordinate research
activities directed towards an improved control of classical swine fever.2001L0089 — EN — 01.05.2004 — 001.001 — 33
▼B
ANNEX V
Main criteria and risk factors to be considered for the decision to kill pigs in contact holdings
CriteriaDecision
For killing Against killing
Clinical signs suggesting clas-
sical swine fever in the contact
holdingsYes No
Movements of pigs from the
outbreak to contact holdings
after the likely time of introduc-
tion of virus in the infected
holdingYes No
Location of contact holdings in
an area with a high density of
pigsYes No
Likely spreading of virus from
the outbreak before application
of eradication measuresMassive/unknown Limited
Location of contact holdings
within 500 metres (1) from the
outbreakYes No
Proximity of contact holdings to
more than one outbreakYes No
Number of pigs in the outbreak
and/or in contact holdingsHigh Low
(1) In case of areas with a very high density of pigs, a longer distance must be considered.2001L0089 — EN — 01.05.2004 — 001.001 — 34
▼B
ANNEX VI
Main criteria and risk factors to be considered for the decision to apply emergency vaccination
in pig holdings
CriteriaDecision
For vaccination Against vaccination
Number/incidence slope of
outbreaks in the previous 10-20
daysHigh/rising rapidly Low/shallow or slow rise
Location of holdings where
vaccination might be applied in
an area with a high density of
pigsYes No
Likelihood of further outbreaks
in the area for the next two
months or moreHighly likely Not likely
Shortage of processing capacity Yes No2001L0089 — EN — 01.05.2004 — 001.001 — 35
▼B
ANNEX VII
Criteria and requirements relating to contingency plans
The Member States are to ensure that contingency plans meet the following
criteria and requirements at least:
(a) provision must be made to ensure that the legal powers necessary for the
implementation of contingency plans exist and make it possible to carry
out a rapid and effective eradication campaign;
(b) provision must be made to ensure access to emergency funds, budgetary
means and financial resources in order to cover all aspects of the fight
against an epizootic of classical swine fever;
(c) a chain of command must be set up to ensure that the decision-taking proce-
dure for an epizootic is rapid and effective. If necessary, the chain of
command must be placed under the authority of a central decision-taking
unit responsible for directing all the strategies for the fight against an
epizootic. The director of the veterinary services must be a member of that
unit and effect the liaison between the central decision-taking unit and the
national disease control centre provided for in Article 23;
(d) provision must be made for appropriate resources to be available to ensure a
rapid and effective campaign, including laboratory staff, equipment and
infrastructure;
(e) an instruction manual must be provided. It must give a full, practical
description in detail of all the procedures, instructions and measures to be
employed in the event of an outbreak of classical swine fever;
(f) if necessary, detailed plans for emergency vaccination must be provided;(g) the staff must regularly take part in:
(i) training in the clinical signs, epidemiological enquiries and combating
classical swine fever;
(ii) alarm drills organised at least twice a year;(iii) training in communications techniques in order to organise information
campaigns concerning an epizootic in progress aimed at the authorities,
farmers and veterinarians.2001L0089 — EN — 01.05.2004 — 001.001 — 36
▼B
ANNEX VIII
Part A
Directive 80/217/EEC and its successive amending acts
(Referred to in Article 28)
Directive 80/1101/EEC (1)
Directive 80/1274/EEC (2) only Article 2
Directive 81/476/EEC (3) only concerning the references made in Articles 1 and 2 of
Directive 80/217/EEC
Directive 84/645/EEC (4)
Directive 85/586/EEC (5) only concerning the references made in Article 5 of Direc-
tive 80/217/EEC
Directive 87/486/EEC (6)
Directive 91/685/EEC (7)
Decision 93/384/EEC (8)
(1) OJ L 325, 1.12.1980, p. 17.
(2) OJ L 375, 31.12.1980, p. 75.
(3) OJ L 186, 8.7.1981, p. 20.
(4) OJ L 339, 27.12.1984, p. 33.
(5) OJ L 372, 31.12.1985, p. 44.
(6) OJ L 280, 3.10.1987, p. 21.
(7) OJ L 377, 31.12.1991, p. 1.
(8) OJ L 166, 8.7.1993, p. 34.2001L0089 — EN — 01.05.2004 — 001.001 — 37
▼B
Part B
Deadlines for transposition into national law
Directive Deadline for transposition
80/217/EEC 1 July 1981
80/1101/EEC
80/1274/EEC 1 July 1981
81/476/EEC84/645/EEC 31 March 198585/586/EEC 1 January 1986
87/486/EEC 31 December 1987
91/685/EEC 1 July 19922001L0089 — EN — 01.05.2004 — 001.001 — 38
▼B
ANNEX IX
Correlation table
This Directive Directive 80/217/EEC
Article 1 Article 1
Article 2(a), (b), (e), (f), (m), (n), (o) and (q) Article 2(a), (e), (g), (h), (i), (j), (k) and (m)
Article 2(c), (d), (g), (h), (i), (j), (k), (l), (p),
(r), (s), (t), (u), (v) and (w)—
Article 3(1) Article 3
Article 3(2) and (3) Article 12
Article 4(1) and (2) Article 4(1)
Article 4(3) —Article 4(4) Article 4(2)
Article 5(1), (a), (c), (d), (f), (g) and (i) Article 5(1), except the seventh indent
Article 5(1) (b), (e), (h) and (2) —
Article 6 Article 6
Article 7(1) and (2), first subparagraph Article 5(2), Article 10(1)
Article 7(2), second subparagraph and (3) —
Article 8, first subparagraph and point (b) of
the second subparagraph—
Article 8, except the abovementioned subpara-
graph and pointArticle 7
Article 9(1), first subparagraph Article 9(1)
Article 9(1), second subparagraph —
Article 9(2), (3) and (4) Article 9(2), (3) and (10)
Article 10(1) except (g) and (h), (2) and (3) Article 9(4)
Article 10(1)(g) and (h) —
Article 10(4) Article 9(5)
Article 11(1) and (2) Article 9(6)
Article 11(3) Article 9(7)Article 12(1) Article 12Article 12(2) —
Article 13, except (1)(b) Article 5(1), seventh indent
Article 13(2)(b) —
Article 14 —
Article 15(1) Article 6a(1)
Article 15(2)(a) and (b), fifth and eight indents —2001L0089 — EN — 01.05.2004 — 001.001 — 39
▼B
This Directive Directive 80/217/EEC
Article 15(2)(b), except the fifth and eight
indentsArticle 6a(2)
Article 15(2)(c) Article 6a(2a)
Article 15(2)(d) and (3) —
Article 16(1), except the fourth subparagraph,
and (2)Article 6a(3) and (4)
Article 16(3) (b), (c), (g), (j), (k), (l) and (n) Article 6a(5)
Article 16(1), fourth subparagraph, (3) (a), (d),
(e), (f), (h), (i), (m), (o), (p), (q) and (4)—
Article 17(1) and (2) Article 11
Article 17(3), (4) and (5) —
Article 18 Article 14(1)(a) and (c) and (5)
Article 19(1), (3), except (h) and (i), (4),
except (c), (5) and (6), except (b)Article 14(2),(3) and (4)
Article 19(2), (3) (h) and (i), (4) (c), (6) (b),
(7), (8) and (9)—
Article 20 —
Article 21 Article 14a
Article 22(1), (2) and (3) Article 14b (1), (2), (4)
Article 23 —Article 24 —Article 26 Article 16Article 27 Article 16a
Article 28 —
Article 29 —Article 30 —Article 31 —
Article 32 Article 20
Annex I —
Annex II, point 1, point 2, first and second
indents and point 3(b)—
Annex II, point 2, except the first and second
indents and point 3(b)Annex V
Annex III, points 1 and 3 Annex II
Annex III, point 2 —
Annex IV Annex VI
Annex V —2001L0089 — EN — 01.05.2004 — 001.001 — 40
▼B
This Directive Directive 80/217/EEC
Annex VI —
Annex VII —2001L0089 — EN — 01.05.2004 — 001.001 — 41