Proposal for a Council Directive on Community measures for the control of classical swine fever (COM(2000) 462 final — 2000/0214(CNS)) (Text with EEA relevance)
Date: 2001-01-30
Institutions: European Commission
Subjects: animal plague, health control, slaughter of animals, swine, vaccine, veterinary legislation

30.1.2001

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Proposal for a Council Directive on Community measures for the control of classical swine fever

(2001/C 531 E/06)

(Text with EEA relevance)

COM(2000) 462 final (cid:151) 2000/0214(CNS)

(Submitted by the Commission on 15 September 2000)

THE COUNCIL OF THE EUROPEAN UNION,

action can be taken as soon as its presence is confirmed,
including depopulation of the infected holding.

Having regard to the Treaty establishing the European
Community, and in particular Article 37 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament,

(6) If an outbreak occurs it is also necessary to prevent any
further spread of
the disease by carefully monitoring
movements of animals and the use of products liable to
be contaminated, cleaning and disinfection of the infected
premises, establishment of surveillance and protection
if necessary, by vacci-
zones around the outbreak and,
nation.

Having regard to the opinion of
Committee,

the Economic and Social

Having regard to the opinion of the Committee of the Regions,

(7) In case of

infection, vaccinated pigs may become
apparently healthy virus carriers and further spread the
disease; the use of vaccines may only be authorised in
emergencies.

Whereas:

(8) Special eradication measures should be applied in case of

disease in feral pigs.

(1) Council Directive 80/217/EEC of 22 January 1980 intro-
ducing Community measures for the control of classical
swine fever (1) has been frequently and substantially
amended; now that it is also to be further amended, the
Directive should, for reasons of clarity and rationality, be
recast as a single text.

(2) Since live animals are listed in Annex I of the Treaty, one
of the Community’s tasks in the veterinary field is to
improve the state of health of pigs, thereby facilitating
trade in pig and pig products to ensure the development
of this sector.

(3) In the event of an outbreak of classical swine fever, it is
necessary to establish at Community level
control
measures to eradicate the disease in order that the devel-
opment of the pig sector is ensured and to contribute to the
protection of animal health in the Community.

(9) Provisions

should be

established to guarantee

that
harmonised procedures and methods are used for the
diagnosis of classical swine fever,
including the estab-
lishment of a Community reference laboratory as well as
reference laboratories in the Member States.

(10) Provisions should be established to ensure the necessary
preparedness to effectively tackle the emergency situations
related to one or more outbreaks of classical swine fever.

(11) 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 into account scientific advances, development of
new diagnostic tools and vaccines and the experiences
gained following the outbreaks of classical swine fever
which recently occurred 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
the disease is suspected so that immediate and effective

(12) In order to ensure the continuity of the coordination of
the diagnostic work carried out under the auspices of the
competent national laboratories, the (cid:145)Institut f(cid:252)r Virologie
der Tier(cid:228)rztlichen Hochschule, Hanover(cid:146), designated by
Council Decision 81/859/EEC (2) should be confirmed as
the Community reference laboratory. For reasons of legal
certainty, Decision 81/859/EEC should be repealed.

(1) OJ L 47, 21.2.1980, p. 11; Directive as last amended by the Act of

(2) OJ L 319, 7.11.1981, p. 20; Decision as amended by Decision

Accession of Austria, Finland and Sweden.

87/65/EEC (OJ L 34, 5.2.1987, p. 54).

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(13) Since the measures necessary for the implementation of
this Directive are measures of general scope within the
meaning of Article 2 of Council Decision 1999/468/EC of
28 June 1999 laying down the procedures for the exercise
of implementing powers conferred on the Commission (1),
they should be adopted by use of the regulatory procedure
provided for in Article 5 of that Decision.

(cid:151) 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)

(cid:145)outbreak of classical swine fever(cid:146) means the holding where
one or more cases of classical swine fever has or have
been detected;

(14) This Directive should not affect the obligations of the
Member States concerning the deadlines for transposition
of the Directives set out in Part B of Annex VII,

(h)

(cid:145)primary outbreak(cid:146) means the outbreak within the meaning
of Article 2(d) of Council Directive 82/894/EEC (2);

HAS ADOPTED THIS DIRECTIVE:

Article 1

Objectives

This Directive introduces the minimum Community measures
for the control of classical swine fever.

Article 2

Definitions

For the purposes of this Directive the following definitions
shall apply:

(a)

(cid:145)pig(cid:146) means any animal of the Suidae family, including feral
pigs;

(b)

(cid:145)feral pig(cid:146) means a pig which is not kept or bred in a
holding;

(c)

(cid:145)holding(cid:146) means any agricultural or other premises located
in the national territory of a Member State where pigs are
being bred or kept on a permanent or temporary basis;
this definition does not include slaughterhouses or means
of transport;

(d)

(cid:145)Diagnostic Manual(cid:146) means the classical swine fever Diag-
nostic Manual referred to in Article 17(3);

(e)

(cid:145)pig suspected of being infected with classical swine fever
virus(cid:146) means any pig or pig carcass exhibiting clinical
symptoms or showing post-mortem lesions or reactions to
laboratory tests carried out in accordance with the Diag-
nostic Manual indicating the possible presence of classical
swine fever;

(f)

(cid:145)case of classical swine fever(cid:146) or (cid:145)pig infected with classical
swine fever(cid:146) means any pig or pig carcass:

(cid:151) in which clinical symptoms or post-mortem lesions of
classical swine fever have been officially confirmed, or

(1) OJ L 184, 17.7.1999, p. 23.

(i)

(j)

(k)

(l)

(cid:145)classical swine fever infected area(cid:146) 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 accordance
with Article 15 or 16;

(cid:145)primary case of classical swine fever in feral pigs(cid:146) 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 Articles 15 or 16;

(cid:145)meta-population of
subpopulation of
other groups or subpopulations;

feral pigs(cid:146) means any group or
feral pigs with limited contacts with

(cid:145)susceptible feral pig population(cid:146) means that part of a feral
pig population which has not developed immunity against
classical swine fever virus;

(m) (cid:145)owner(cid:146) means any person or persons, either natural or
legal, having ownership of
the pigs, or charged with
keeping the said animals, whether or not for financial
reward;

(n)

(cid:145)competent authority(cid:146) means
the competent authority
within the meaning of Article 2(6) of Council Directive
90/425/EEC (3);

(o)

(cid:145)official veterinarian(cid:146) means the veterinarian designated by
the competent authority of the Member State;

(p)

(q)

(cid:145)processing(cid:146) means the processing or disposal by burying
or burning of high risk material in accordance with Article
3 of Council Directive 90/667/EEC (4) in such a way as to
avoid the risk of spread of classical swine fever virus;

(cid:145)swill(cid:146) means waste from kitchens, restaurants, catering
farmer or persons
facilities,
attending susceptible animals or from industries using
meat fit for human consumption;

the household of

the

(2) OJ L 378, 31.12.1982, p. 58; Directive as

last amended by

Commission Decision 98/12/EC (OJ L 4, 8.1.1998, p. 63).

(3) 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).

(4) OJ L 363, 27.12.1990, p. 51; Directive as last amended by the Act

of Accession of Austria, Finland and Sweden.

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(cid:145)marker vaccine(cid:146) means a vaccine that can elicit a
protective immunity distinguishable from the immune
infection with the wild
response elicited by the natural
type virus by means of
laboratory tests carried out in
accordance with the Diagnostic Manual;

(cid:145)killing(cid:146) means the killing of pigs within the meaning of
Article 2(6) of Council Directive 93/119/EEC (1);

(cid:151) the results of the epidemiological enquiry carried out in

accordance with Article 8;

(b) provide information to the Commission and the other
Member States on the further cases confirmed in feral
pigs in a classical swine fever infected area in accordance
with the provisions laid down in Article 16(3)(a) and (4).

(cid:145)slaughter(cid:146) means the slaughter of pigs within the meaning
of Article 2(7) of Directive 93/119/EEC;

3.
The provisions of Annex I may be supplemented or
amended in accordance with the procedure referred to in
Article 25(2).

(r)

(s)

(t)

(u)

(cid:145)area with a high density of pigs(cid:146) means any geographical
area with a radius of 10 km around a holding containing
pigs suspected to be or known to be infected with classical
swine fever virus, where there is a pig density higher than
800 pigs per km2; the holding in question must be located
either in a region, as defined in accordance with point (p)
of Article 2 of Council Directive 64/432/EEC (2), where
there is a density of pigs kept in holdings higher than
300 pigs per km2, or at a distance of less than 20 km
from such a region;

(v)

(cid:145)contact holding(cid:146) 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

the presence and
shall ensure that
1. Member States
suspected presence of classical swine fever are compulsorily
and immediately notifiable to the competent authority.

2. Without prejudice to existing Community provisions on
notification of outbreaks of animal diseases, the Member State
in whose territory classical swine fever is confirmed shall:

(a) give notification of the disease and provide information to
in

the Commission and the other Member
accordance with Annex I on:

States

Article 4

Measures in case of suspicion 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 ensure that the competent authority immediately sets in
motion official means of investigation to confirm or rule out
the presence of
the said disease in 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 and 5 of Council Directive 92/102/EEC (3) shall also
be carried out.

competent

2. When the
suspected presence of classical
cannot be ruled out,
official surveillance and shall in particular order that:

the
that
in a holding
it shall have the holding placed under

authority considers
swine fever

(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 period of suspicion;
the
information on the list shall be produced upon request
and may be checked at each visit;

(cid:151) the outbreaks of classical
confirmed in holdings;

swine fever which are

(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;

(cid:151) the cases of classical swine fever which are confirmed in

a slaughterhouse or in means of transport;

(cid:151) the primary cases of classical swine fever which are

confirmed in feral pigs;

(1) OJ L 340, 31.12.1993, p. 21.
(2) OJ 121, 29.7.1964, p. 1977/64; Directive as last amended by
European Parliament and Council Directive 2000/20/EC (OJ L
163, 4.7.2000, p. 35).

(c) no pigs may enter or leave the holding. The competent
if necessary, extend the ban on leaving

authority may,
the holding to cover other species of animals;

(d) no pig carcases may leave the holding without an author-

isation issued by the competent authority;

(3) OJ L 355, 5.12.1992, p. 32; Directive as amended by the Act of

Accession of Austria, Finland and Sweden.

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(e) no meat, 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 the competent authority; meat, semen, ova and
embryos shall not be moved from the holding for intra-
Community trade;

(f)

the movement of persons to or from the holding shall be
competent
subject
authority;

to written authorisation by

the

(g) the movement of vehicles to or from the holding shall be
competent

to written authorisation by

the

subject
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 observe appropriate hygienic measures necessary to
reduce the risk of spread of classical swine fever virus;

(i) an epizootiological

enquiry shall be

carried out

in

accordance with Article 8.

3. Where required by the epidemiological situation and in
particular if the holding containing suspected pigs is located in
an area with a high density of pigs, the competent authority:

(a) may apply the measures of Article 5(1)

in the holding
referred to in (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 the holding where they
were kept, provided that these pigs have been housed, kept
and fed completely separately from the other pigs in the
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;

(b) may establish a suspect-protection zone around the holding
referred to in (2); some or all the measures referred to in (1)
or (2) shall be applied in the pig holdings within this zone.

4.
The measures provided for in (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 classical swine fever
in pigs in 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 to the measures referred to in Article 4(2), the
competent authority prescribes 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 of classical swine fever virus during transport or
killing;

(b) a sufficient number of samples are to taken from the pigs
when they are killed, in order that the manner of intro-
duction of classical swine fever virus into the holding and
the length of time during which it may have existed on the
holding before the disease was notified may be established;

(c)

the carcasses 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
taking of official
disease
measures shall be traced and destroyed under official super-
vision in such a way as to avoid the risk of spread of
classical swine fever virus;

into the holding and the

(f) all substances and waste likely to be contaminated, such as
feedingstuffs, must be subjected to a treatment ensuring the
destruction of classical swine fever virus; this treatment
shall be carried out in accordance with the instructions
of the official veterinarian;

(g) after the pigs have been eliminated, the buildings used for
housing the pigs, the vehicles used for transporting them
or their carcasses and the equipment, bedding, manure and
slurry likely to be contaminated shall be cleaned and disin-
fected or treated in accordance 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 laid down in the Diagnostic Manual to identify
the genetic type;

(i) an epizootiological

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 wild life park or a fenced area where
pigs are kept for scientific purposes or purposes related to
conservation of species or conservation of rare breeds, the
Member State concerned may decide to derogate from the
provisions laid down in (1)
(e), provided that
basic Community interests are not endangered.

(a) and (1)

This decision shall immediately be notified to the Commission.

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in all cases immediately review the
The Commission shall
situation with the Member State concerned and in the
Standing Veterinary Committee at the earliest possible oppor-
tunity. If necessary, measures to prevent the spreading of the
disease shall be adopted in accordance with the procedure
referred to in Article 26(2), which may include emergency
vaccination in accordance with the procedure laid down to
in Article 19.

Article 6

Measures in the event of confirmation of classical swine
fever in holdings consisting of different epidemiological
units

1.
In the case of holdings which consist of two or more
separate production units and in order that fattening of pigs
may be completed, the competent authority may decide to
derogate from the provisions of Article 5(1)(a) as regards
healthy pig production units on a holding which is infected
provided that the official veterinarian has confirmed that the
structure and size of these production units and the operations
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.

If use is made of the derogation referred to in (1), the
2.
Member States shall draw up detailed rules for applying it in
the light of the animal health guarantees which can be given.

3. Member States which make use of this derogation shall
immediately notify the Commission thereof. The Commission
shall
in all cases immediately review the situation with the
Member State concerned and in the Standing Veterinary
If necessary,
Committee at the earliest possible opportunity.
measures to prevent
the disease shall be
the spreading of
adopted in accordance with the procedure laid down in
Article 26(2).

Article 7

Measures in contact holdings

Holdings shall be considered contact holdings where the
1.
the
official veterinarian finds, or considers on the basis of
epidemiological
in accordance with
enquiry carried out
Article 8, that classical swine fever may have been introduced,
either from other holdings to the holding referred to in Article
4 or Article 5, or from the holding referred 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.

The

2.
competent authority shall apply the measures
provided for in Article 5(1) in the contact holdings referred
to in (1) of this Article if the epidemiological situation so
requires.

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 in these holdings can be confirmed or
ruled out.

The main criteria to be considered for the application of
3.
the measures provided for in Article 5(1)(a) in contact holdings
are laid down in Annex V. These criteria may subsequently be
amended or supplemented to take account of scientific devel-
in accordance with the procedure
opments and experiences,
referred to in Article 25(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 out on 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 or suspected;

(b) the possible origin of classical swine fever on the holding
and the identification of other holdings in which pigs may
have become infected or contaminated from the same
source;

(c) the movement of persons, vehicles, pigs, carcases, semen,
meat or any material likely to have transported the virus to
or from the holdings 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 immediately informed.

Article 9

Establishment of protection and surveillance zones

Immediately after the diagnosis of classical swine fever
1.
has been officially confirmed in pigs on a holding,
the
competent authority shall establish a protection zone with a
radius of at least three kilometres around the outbreak site,
which shall
itself be included in a surveillance zone of a
radius of at least ten 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 boundaries;

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(c) the location and proximity of holdings;

fected and then inspected and authorised by the competent
authority;

(d) patterns of trade in breeding and slaughter pigs and the

availability of slaughterhouses;

(d) no other species of animal may enter or leave a holding
without the authorisation of the competent authority;

(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.

If a zone includes parts of the territory of several Member
the Member States

3.
the competent authorities of
States,
concerned shall collaborate to establish the zone.

The

take

shall

authority

competent

all necessary
4.
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 the restrictions in force
in accordance with Articles 10 and 11, and shall take such
measures as they consider appropriate to ensure the adequate
enforcement of these measures.

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 days for a clinical examination
of the pigs and for a check of the register and of the pig
identification marks referred to in Articles 4 and 5 of
Directive 92/102/EEC;

(b) the movement and transport of pigs on public or private
roads, excluding the service roads of holdings, shall be
prohibited unless approved by the competent authority to
allow the movements referred to in (f). This prohibition
shall not apply to the transit of pigs by road or rail
in accordance
without unloading or stopping. However,
with the procedure referred to in Article 26(2), a dero-
gation may be granted for slaughter pigs coming from
outside the protection zone and on their way to a slaugh-
terhouse situated in the said zone;

(c) trucks and other vehicles and equipment, which are used to
transport pigs or other livestock or material which may be
contaminated (e.g. carcasses, 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 of
pigs may leave the zone without being cleaned and disin-

(e) all dead or diseased pigs on a holding shall be immediately
notified to the competent authority, which shall carry out
appropriate investigations 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 30 days after the completion of the
preliminary cleaning and disinfection of
infected
holdings. After 30 days, subject to the conditions set out
in (3), the competent authority may authorise the removal
of pigs from the said holding to be directly transported to:

the

(cid:151) a slaughterhouse designated by the competent authority,
preferably within the protection or surveillance zone for
the purpose of immediate slaughter;

(cid:151) a rendering plant or a suitable place where the pigs are
immediately killed and their carcasses are processed
under official supervision; or

(cid:151) under exceptional circumstances,
located within the protection zone;

to other premises

(g) semen, ova and embryos of pigs shall not
holdings situated within the protection zone;

leave the

(h) any person entering or leaving pig holdings shall observe
appropriate hygienic measures necessary to reduce the risk
of spread of classical swine fever virus.

2. Where the prohibitions provided for in paragraph 1 are
maintained beyond 30 days because of further outbreaks of the
disease and as a result animal welfare or other problems that
arise in keeping the pigs, subject to the conditions set out in
(3),
following a reasoned
application by the owner, authorise removal of pigs from a
holding within the protection zone, to be directly transported
to:

the competent authority may,

(a) a slaughterhouse designated by the competent authority,
preferably within the protection or surveillance zone for
the purpose of immediate slaughter;

(b) a rendering plant or a suitable place where the pigs are
immediately killed and their carcasses are processed under
official supervision; or

(c) under exceptional circumstances, to other premises located

within the protection zone.

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3. When reference is made to this paragraph, the competent
authority may authorise removal of pigs from the holding
concerned, on condition that:

The measures in the protection zone shall continue to be

4.
applied at least until:

(a) a clinical examination of the pigs in the holding and in
particular those to be moved, including the taking of the
body temperature of a proportion thereof, and a check of
the register and the pig identification marks referred to in
Articles 4 and 5 of Directive 92/102/EEC, have been carried
out by an official veterinarian;

(a) cleaning and disinfection in the infected holdings have been

carried out;

(b) pigs on all holdings have undergone clinical and laboratory
examinations carried out in accordance with the Diagnostic
Manual in order to detect the possible presence of classical
swine fever virus.

(b) the checks and examinations above have shown no
evidence of classical swine fever and compliance with the
provisions of Directive 92/102/EEC;

The examinations referred to in (b) shall not take place before
30 days have elapsed after the completion of preliminary
cleaning and disinfection measures on the infected holdings.

(c) the pigs are transported in vehicles sealed by the competent

authority;

Article 11

(d) the vehicle and equipment which have been involved in the
transport of the pigs are immediately cleaned and disin-
fected after the transport in accordance with the provisions
referred to in Article 12;

(e) if

the pigs are to be slaughtered or killed, a sufficient
number of samples shall be taken from the pigs in order
that the presence of classical swine fever virus in these
holdings can be confirmed or ruled out;

(f)

if the pigs are to be transported to a slaughterhouse:

(cid:151) the competent authority responsible for the slaugh-
the intention to send
the dispatching competent

terhouse shall be informed of
pigs
to it and notifies
authority of their arrival;

(cid:151) on arrival at the slaughterhouse these pigs shall be kept

and slaughtered separately from other pigs;

(cid:151) during ante and post-mortem inspection carried out at
competent
slaughterhouse,
the
authority shall take into account any signs relating to
the presence of classical swine fever;

designated

the

(cid:151) the fresh meat from these pigs shall be either processed
or marked with the special stamp referred to in Article
5a of Council Directive 72/461/EEC (1) and subsequently
treated in accordance with the rules laid down in
Article 4(1) of Council Directive 80/215/EEC (2). This
shall be done at an establishment designated by the
competent authority. The meat shall be sent
to the
said establishment on condition that the consignment
is
sealed
throughout the transport.

departure

remains

before

sealed

and

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 the service roads of holdings, shall be
prohibited, unless approved by the competent authority.
This prohibition shall not apply to the transit of pigs by
road or rail, without unloading or stopping;

(c) trucks and other vehicles and equipment, which are used to
transport pigs or other livestock or material which may be
contaminated (e.g. carcasses, 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 of
pigs may leave the zone without having been cleaned and
disinfected;

(d) no other species of animal may enter or leave a holding
during the first seven days after establishment of the zone
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
the
appropriate
procedures laid down in the Diagnostic Manual;

accordance with

investigations

in

(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 cleaning and disinfection of
infected
holdings. After 21 days, subject to the conditions set out
in Article 10(3), the competent authority may authorise the
removal of the pigs from the said holding to be directly
transported to:

the

(1) OJ L 302, 31.12.1972, p. 24; Directive as last amended by the Act

of Accession of Austria, Finland and Sweden.

(2) OJ L 47, 21.2.1980, p. 4; Directive as last amended by the Act of

Accession of Austria, Finland and Sweden.

(cid:151) a slaughterhouse designated by the competent authority,
preferably within the protection or surveillance zone for
the purpose of immediate slaughter,

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(cid:151) a rendering plant or a suitable place where the pigs are
immediately killed and their carcasses are processed
under official supervision; or

Article 12

Disinfection

(cid:151) under exceptional circumstances,

to other premises

located within the protection or surveillance zone.

(a) the disinfectants to be used and their concentrations are

officially approved by the competent authority;

1. Member States shall ensure that:

However,
if the pigs are to be transported to a slaugh-
terhouse, at the request of a Member State, accompanied
by appropriate justification, and in accordance with the
procedure referred to in Article 26(2), derogations to the
provisions laid down in Article 10(3)(e) and (f),
fourth
in particular with respect to
indent, may be authorised,
the marking of meat of these pigs and its subsequent use,
and the destination of the processed products;

(g) semen, ova and embryos of pigs shall not
holdings situated within the surveillance zone;

leave the

(h) any person entering or leaving pig holdings shall observe
appropriate hygienic measures necessary to reduce the risk
of spread of classical swine fever virus.

2. Where the prohibitions provided for in paragraph 1 are
maintained 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),
following a
the competent authority may,
reasoned application by the owner, authorise removal of pigs
from a holding within the surveillance zone to be directly
transported to:

(a) a slaughterhouse designated by the competent authority,
preferably within the protection or surveillance zone for
the purpose of immediate slaughter;

(b) a rendering plant or a suitable place where the pigs are
immediately killed and their carcasses are processed under
official supervision; or

(c) under exceptional circumstances, to other premises located

within the protection or surveillance zone.

The measures in the surveillance zone shall continue to

3.
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
laboratory examinations as laid down in the
eventual

necessary,
Diagnostic Manual
presence of classical swine fever virus.

to detect

in order

the

The examinations referred to in (b) shall not take place before
20 days have elapsed after the completion of preliminary
cleaning and disinfection measures on the infected holdings.

(b) the cleaning and disinfection operations are carried out

under official supervision in accordance with:

(cid:151) the instructions given by the official veterinarian; and

(cid:151) the principles and procedures for cleaning, disinfecting

and treatment laid down in Annex II.

2.
The principles and procedures for cleaning and disin-
fecting laid down in Annex II may subsequently be amended
or supplemented to take account of scientific developments and
experiences, in accordance with the procedure referred to in
Article 25(2).

Article 13

Repopulation of pig holdings following disease outbreaks

The reintroduction of pigs to the holding referred to in
least 30 days after
the cleaning and disinfection operations in

1.
Article 5 shall not
completion of
accordance with Article 12.

take place until at

The reintroduction of pigs shall take account of the type
farming practised on the holding concerned and must

2.
of
conform to one of the following procedures:

(a) as regards open-air pig holdings, the reintroduction of pigs
shall start with the introduction of sentinel pigs which have
been checked and found negative for
the presence of
antibodies against classical swine fever virus or come
from holdings situated outside the restriction zone. The
sentinel pigs
in accordance with the
requirements of the competent authority, throughout the
infected holding and be sampled 40 days after having
been placed on the holding, and tested for the presence
of antibodies, in accordance with the Diagnostic Manual.

shall be placed,

If none of
the pigs has developed antibodies against
classical swine fever virus, full repopulation may take place;

(b) as regards all other forms of rearing, the reintroduction of
pigs shall either take place in accordance with the measures
provided for in (a) or shall be based on total repopulation,
provided that:

(cid:151) all the pigs arrive within a period of twenty days and
come from holdings situated outside the restriction
zone;

(cid:151) pigs in the repopulated herd are subjected to a sero-
logical 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;

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(cid:151) no pig may leave the holding before the negative results

(cid:151) studying the epidemiological situation and defining an

of the serological examination are available.

infected area;

Article 14

Measures in case of classical swine fever in pigs in a
slaughterhouse or means of transport

Should a case of classical swine fever be detected in a slaugh-
terhouse or means of transport, the competent authority shall
ensure that:

(cid:151) establishing appropriate measures to be applied in the
infected area in addition to the ones referred to in (b)
and (c);
these measures may include suspension of
hunting and a ban in feeding feral pigs;

(cid:151) drawing up the eradication plan to be submitted to the

Commission in accordance with Article 16;

(a) all susceptible animals in the slaughterhouse or in the

means of transport are killed without delay;

(cid:151) carrying out audits to verify the effectiveness of the
measures adopted to eradicate classical swine fever
from the infected area;

(b) the carcasses, offal and animal waste of possibly infected
and contaminated animals are processed under official
supervision;

(c) cleaning and disinfection of buildings and equipment,
takes place under the supervision of

including vehicles,
the official veterinarian 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 the genetic type of virus;

(f)

the measures referred to in Article 7 are applied in the
holding where the infected pigs or carcasses came from
and in the other contact holdings;

(g) no animals are reintroduced for slaughter or transport until
the cleaning and
completed in accordance with

at least 24 hours after completion of
disinfection operations
Article 12.

Article 15

Measures to be adopted in case of suspicion and confir-
mation of classical swine fever in feral pigs

Immediately after the competent authority of a Member
1.
State has information that feral pigs are suspected of being
infected, it shall take all appropriate measures to confirm or
rule out the presence of the disease, by giving information to
the owners of pigs and to hunters, and by investigations of all
feral pigs shot or found dead, including laboratory testing.

As soon as confirmation of a primary case of classical
the competent

2.
swine fever
authority of a Member State shall immediately:

in feral pigs has taken place,

(b) place under official surveillance pig holdings in the defined

infected area and shall in particular order that:

(cid:151) 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 pig holdings,
the first census carried out may be done on the basis of
an estimate;

(cid:151) all pigs on the holding be kept in their living quarters
or some other place where they can be isolated from
feral pigs. The feral pigs must not have access to any
material which may subsequently come in contact with
the pigs on the holding;

(cid:151) no pigs enter or leave the holding save where auth-
orised by the competent authority having regard to
the epidemiological situation;

(cid:151) appropriate means of disinfection be used at

the
entrance and exits of buildings housing pigs and of
the holding itself;

(cid:151) appropriate hygienic measures be applied by all persons
coming in contact with feral pigs, to reduce the risk of
spread of classical swine fever virus;

(cid:151) all dead or diseased pigs with classical swine fever
symptoms on a holding be tested for the presence of
classical swine fever;

(cid:151) no part of any feral pig, whether shot or found dead, as
well as any material or equipment which could be
contaminated with classical swine fever virus shall be
brought into a pig holding;

(a) establish an expert group including veterinarians, hunters,
wild life biologists and epidemiologists. The expert group
shall assist the competent authority in:

(cid:151) pigs, their semen, embryos or ova shall not be moved

from the area for intra-Community trade;

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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 for classical swine fever in accordance with the
Diagnostic Manual. Carcasses of all animals found positive
shall be processed under official supervision. Where such
testing proves negative as regards classical swine fever,
Member States shall apply the measures laid down 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 of disease 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 from the 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 holdings 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 necessary with amendments, shall be approved in
accordance with the procedure referred to in Article 26(2).

The plan may subsequently be amended or supplemented to
take account of developments in the situation.

If these amendments concern the re-definition of the infected
area, Member States shall ensure that the Commission and the
other Member States are informed of
these amendments
without delay.

the amendments concern other provisions of
submit

If
Member States
Commission for
approval
accordance with the procedure referred to in Article 26(2).

the plan,
amended plan to the
in

the
examination and eventual

shall

2.
After the measures provided for in the plan mentioned in
paragraph 1 have been approved, they shall replace the initial
measures laid down in Article 15, on a date which shall be
decided upon when approval is given.

The plan mentioned in paragraph 1 shall contain

3.
information on:

(a)

the results of
investigations and
controls carried out in accordance with Article 15 and
the geographical distribution of the disease;

the epidemiological

(1) 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) a defined infected area within the territory of the Member
State concerned. When defining the infected area,
the
competent authority shall take into account:

(cid:151) the results of the epidemiological investigations carried
out and the geographical distribution of the disease;

(cid:151) the feral pig population in the area;

(cid:151) the existence of major natural or man-made obstacles

to movements of feral pigs;

the organisation of close cooperation between biologists,
hunters, hunting organisations, the wildlife services and
veterinary services (animal health and public health);

the information campaign to be enforced to increase
hunters’ awareness of the measures they have to adopt
in the framework of the eradication plan;

specific efforts made to determine the number and
location of feral pig meta-populations in and around the
infected area;

(c)

(d)

(e)

(f)

the approximate number of meta-populations of feral pigs
and their size in and around the infected area;

(g)

(h)

(i)

(j)

specific efforts made to determine the extent of
the
infection in the feral pig population, by investigation of
feral pigs
found dead, and by
laboratory testing, including age-stratified epidemiological
investigations;

shot by hunters or

the measures adopted to reduce spread of disease due to
feral pig movements and/or contact between meta-popu-
lations of
these measures may include a
feral pigs;
prohibition of hunting;

the measures adopted to reduce the susceptible feral pig
population and in particular young piglets;

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:

(cid:151) processing under official supervision; or

(cid:151) inspection by an official veterinarian and laboratory
in the Diagnostic Manual.
tests as provided for
found positive shall be
Carcasses of all animals
such
supervision. Where
processed under official
testing proves negative as
swine
regards classical
fever, Member States shall apply the measures laid
down in Article 11(2) of Directive 92/45/EEC. Parts
not
intended for human consumption shall be
processed under official supervision;

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(l)

the epidemiological enquiry which is carried out on each
feral pig, whether shot or found dead. This enquiry must
include the completion of a questionnaire which supplies
information about:

Article 17

Diagnostic procedures and bio-safety requirements

1. Member States shall ensure that:

(cid:151) the geographical area where the animal was found

dead or shot;

(cid:151) the date on which the animal was found dead or shot;

(cid:151) the person who found or shot the animal;

(cid:151) the age and sex of the pig;

(cid:151) if shot: symptoms before shooting;

(cid:151) if found dead: the state of the carcass;

(cid:151) laboratory findings;

(m) surveillance

and

programmes

prevention measures
applicable to the holdings situated in the defined infected
including the transport and movement of animals
area,
these measures shall at
within,
least
semen,
embryos or ova from the area for intra-Community trade;

include the ban of moving pigs,

from and to the area;

their

(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

coordinating
standards and methods of diagnosis in each Member State
in accordance with the provisions of Annex III.

responsible

for

2.
The national laboratories referred to in (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.

In order

3.
to diagnose
to ensure uniform procedures
classical swine fever, within two months from the date when
this Directive enters into force and in accordance with the
procedure referred to in Article 25(2), a classical swine fever
Diagnostic Manual shall be approved, establishing at least:

(a) minimum bio-safety requirements and quality standards to
be observed by the classical swine fever diagnostic labora-
tories and for the transport of samples;

(n) other criteria to be applied for lifting the measures taken
to eradicate the disease in the defined area and the
measures applied to holdings in the area;

(b) criteria and procedures to be followed when clinical or
to confirm or

post-mortem examinations are carried out
exclude the presence of classical swine fever;

(o)

the authority charged with supervising and coordinating
the departments responsible for implementing the plan;

(p)

(q)

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;

least

the disease monitoring measures that shall be enforced
after a period of at
twelve months has elapsed
from the last confirmed case of classical swine fever in
feral pigs in the defined infected area; these monitoring
measures shall stay in place for at least twelve months and
shall at least
include the measures already enforced in
accordance with (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 the Commission and to the other Member States
every six months.

(c) criteria and procedures to be followed for collection of
samples from live pigs or their carcasses, to confirm or
exclude classical swine 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 this Directive;

(d) laboratory tests to be used for the diagnosis of classical

swine fever, including:

(cid:151) tests for

the differential diagnosis between classical

swine fever virus and other Pestiviruses, and

(cid:151) if available and suitable, tests to distinguish the antibody
pattern elicited by a marker vaccine from the one
elicited by the wild type of classical swine fever virus;

(cid:151) criteria for

the
laboratory tests;

evaluation of

the

results of

the

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 25(2).

(e) laboratory techniques for the genetic typing of classical

swine fever virus isolates.

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In order

that appropriate bio-safety conditions are
4.
guaranteed to protect animal health, the classical swine fever
virus,
its genome and antigens and vaccines for research,
diagnosis or manufacture shall be manipulated or used out
only in places, establishments or laboratories approved by
the competent authority.

(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 vaccinated;

The list of approved places, establishments or laboratories shall
be transmitted to the Commission within six months from the
date laid down in Article 29, second subparagraph and kept
updated hereafter.

(d)

the vaccine to be used;

(e) the duration of the vaccination campaign;

The provisions of Annexes III and IV and the Diagnostic
5.
Manual may be supplemented or amended in accordance with
the procedure referred to in Article 25(2).

(f)

the identification and registration of the vaccinated animals;

(g) measures for the movement of pigs and their products;

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
the Community are carried out under official control.

2.
If necessary, rules relating to the production, packaging,
distribution and state of the stocks of classical swine fever
vaccines in the Community may be adopted in accordance
with the procedure referred to in Article 25(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 epidemio-
logical data available suggest
to spread,
emergency vaccination may be introduced in pig holdings in
accordance with the procedures and provisions laid down in
paragraphs 2 to 9 of this Article.

threatens

that

it

2. Without prejudice to the provisions of Article 5(2), the
main criteria to be considered for the application of emergency
vaccination are laid down in Annex VI. These criteria may
subsequently be amended or supplemented to take account of
scientific developments and experiences, in accordance with the
procedure referred to in Article 25(2).

3. Where a Member State intends to introduce vaccination,
it shall submit to the Commission an emergency vaccination
plan, which shall at least include information on:

(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 holdings;

(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 colla-
boration with the Member State concerned. In accordance with
the procedure referred to in Article 26(2), the emergency vacci-
nation plan may be approved or amendments and additions
may be requested before approval is given.

In accordance with the procedure referred to in Article 26(2),
the emergency vaccination plan may subsequently be amended
or supplemented to take account of developments in the
situation.

Any Member State which carries out emergency vacci-

4.
nation shall ensure that during the vaccination period:

(a) no live pigs leave the vaccination area, unless to be trans-
ported to a slaughterhouse designated by the competent
authority and situated within the vaccination area or
close to that area for
to a
rendering plant or to a suitable place where they are
immediately killed and their carcasses are processed under
official supervision;

immediate slaughter or

(b) all fresh pig meat produced from pigs vaccinated during the
emergency vaccination is either processed or marked and
treated in accordance 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 thirty days prior to vaccination are
traced and destroyed under official supervision.

(a) the disease situation which has led to the request

for

emergency vaccination;

The provisions

5.
shall apply for a
laid down in (4)
minimum of six months following completion of the vacci-
nation operations in the affected area.

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In accordance with the procedure referred to in Article
6.
26(2) and before the end of the six-month period referred to in
(5), measures shall be taken to ban:

(a) sero-positive pigs from leaving the holding where they are

kept, except for immediate slaughter;

(b) the collection of semen, embryos or ova from sero-positive

pigs;

(c) piglets of sero-positive sows from leaving their holding of

origin unless being transported to:

(cid:151) a slaughterhouse for immediate slaughter;

(cid:151) a holding designated by the competent authority, from
which they are to be sent directly to the slaughterhouse;

(cid:151) a holding after obtaining a negative result from a sero-
for antibodies against the classical swine

logical
test
fever virus.

holdings where vaccine has been applied have been
slaughtered or killed;

(b) after reintroduction, pigs on all holdings in the vaccination
area shall undergo clinical and, where necessary, laboratory
examinations as laid down in the Diagnostic Manual
in
the possible presence of classical swine
order to detect
fever virus.
In case of pigs re-introduced in holdings
where the vaccine had been applied, these examinations
shall not take place until at least 40 days have elapsed
after the reintroduction, during which time pigs shall not
be allowed to move from the holding.

9.
In those cases where a marker vaccine has been used
from the
during the vaccination campaign, derogations
provisions referred to in (4), (5) and (6) may be authorised
in accordance with the procedure referred to in Article 26(2),
in particular with respect
the
vaccinated pigs and its subsequent use, and the destination of
the processed products. Such authorisation shall be subject to
the following conditions:

to the marking of meat of

7.
By way of derogation from the provisions laid down in
(3), the decision to introduce emergency vaccination may be
taken by a Member State if the following conditions are met:

(a) the vaccination plan shall have been approved before the
starting of the vaccination operations in accordance with
the provisions referred to in (3);

(a) the emergency vaccination plan must be submitted and the
decision to adopt vaccination must be notified to the
vaccination
Commission before
operations;

starting of

the

the

(b) in addition to the information referred to in (3), the plan
must prescribe that all the pigs in the holdings where the
vaccine is to be used will be slaughtered or killed as quickly
as possible after completion of the vaccination operations
in accordance with the provisions laid down in 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 the procedure referred to in Article 26(2),
the plan may be approved or amendments and additions may
be requested before approval is given.

Notwithstanding the provisions laid down in (5) and (6), the

8.
measures provided for in (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 the
(a), and the fresh meat
provisions
produced from these pigs has been either processed or
marked and treated in accordance with the provisions laid
down in Article 10(3)(f), fourth indent;

laid down in (4)

(b) all the holdings where vaccinated pigs had been kept have
been cleansed and disinfected in accordance with Article
12.

Where the measures provided for in (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
in the
and disinfection operations, and after all pigs

(b) a specific request shall have been submitted by the Member
State concerned, accompanied by a comprehensive report
on the implementation of the vaccination campaign,
its
results and the overall epidemiological situation; and

(c) an on-the-spot check on the implementation of the vacci-
nation campaign shall have been carried out in accordance
with the procedures referred to in Article 21.

The adoption of
the derogations referred to in the first
paragraph 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 pigs may be introduced in accordance
with the procedures and provisions laid 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
this area
vaccination is to be carried out.
shall be part of the infected area defined in accordance
with Article 16(3)(b);

In any case,

(c) the type of vaccine to be used and the procedure of vacci-

nation;

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(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;

(i)

(j)

the expected results of the vaccination campaign and the
parameters that will be considered to verify its effectiveness;

the authority charged with supervising and coordinating
the departments 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 the results of the vaccination campaign;

(l) other matters appropriate to the emergency.

The Commission shall immediately examine the plan in colla-
in particular to
boration with the Member State concerned,
ensure its consistency with the measures applied in accordance
with the eradication plan provided for in Article 16(1).

the vaccination area is close to the territory of another
If
Member State where measures to eradicate classical swine
fever from feral pigs are also in place, consistency between
the vaccination plan and the measures applied in such other
Member State shall also be ensured.

emergency

In accordance with the procedure referred to in Article 26(2),
the
approved or
vaccination plan may be
amendments and additions may be requested before approval
is given.

In accordance with the procedure above, the emergency vacci-
nation plan may subsequently be amended or supplemented to
take account of developments in the situation.

A report concerning the results of

the vaccination
3.
campaign shall
State
concerned to the Commission and the other Member States
together with the report referred to in
every six months,
Article 16(4).

the Member

transmitted

by

be

Article 21

On-the-spot checks

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 eradication of the outbreak.
It shall give a precise
indication of the vaccine requirements which each Member
State concerned considers it needs in the event of emergency
vaccination.

The criteria and requirements

2.
to be applied mutatis
mutandis for drawing up the contingency plan shall be those
laid down in Community legislation laying down the criteria
and requirements to be applied when drawing up contingency
plans for the control of foot-and-mouth disease.

In accordance with the procedure referred to in Article 25(2),
those criteria and requirements may be amended or supple-
mented taking into account
the specific nature of classical
swine fever and progress made in the development of disease
control measures.

The Commission shall examine the plans in order to
the desired objective to be
to the Member State concerned
in particular to ensure that they

3.
determine whether they permit
attained and shall suggest
any amendments required,
are compatible with those of the other Member States.

The plans,
accordance with the procedure referred to in Article 25(2).

if necessary amended,

shall be approved in

The plans may subsequently be amended or supplemented, in
accordance with the procedure referred to in Article 25(2), to
take into account developments in the situation. In any case,
every five years each Member State shall update the plan and
submit it to the Commission for approval in accordance with
the procedure referred to in Article 25(2).

Article 23

Disease control centres

In order to provide full coordination of all measures necessary
for a quick eradication of classical swine fever, Member States
shall ensure that with regard to the establishment, function,
responsibilities and duties of disease control centres and
expert groups, the provisions referred to in Community legis-
lation for the control of foot-and-mouth disease shall apply
mutatis mutandis.

Veterinary experts from the Commission may, in collaboration
with the authorities of the Member State concerned and, in so
far as it is necessary to ensure uniform application of this
Directive, make on-the-spot checks in accordance with the
procedures laid down in Commission Decision 98/139/EC (1).

(1) OJ L 38, 12.2.1998, p. 10.

Article 24

Control of swill feeding

Member States shall ensure that with regard to swill feeding the
provisions referred to in Community legislation for the control
of foot-and-mouth disease shall apply mutatis mutandis.

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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, within 90 days of the date laid
to the
down in Article 29, second subparagraph, submit
Commission amendments to these plans, taking into account
the provisions laid down in Article 16(3).

The plans, amended as necessary,
accordance with the procedure referred to in Article 26(2).

shall be approved in

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.

4.
However, Member States shall, within six months of the
date laid down in Article 29, second subparagraph, submit to
the Commission amendments
taking into
to these plans,
account the provisions laid down in Article 22.

The plans, amended as necessary,
accordance with the procedure referred to in Article 25(2).

shall be approved in

Article 29

Transposition into national legislation and application

Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this
Directive by 31 March 2001 at
the latest. They shall
forthwith inform the Commission thereof.

Member States shall apply the provisions of this Directive as
from 1 April 2001.

When Member States adopt the provisions referred to in the
first paragraph, they shall contain a reference to this Directive
or be accompanied by such a reference on the occasion of their
official publication. Member States shall determine how such
reference is to be made.

Article 30

Entry into force

This Directive shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
European Communities.

Article 31

Addressees

This Directive is addressed to the Member States.

Article 25

Normal regulatory procedure

The Commission shall be assisted by the Standing
by Council Decision

established

1.
Veterinary Committee
68/361/EEC (1).

2. Where reference is made to this paragraph, the regulatory
procedure laid down in Article 5 of Decision 1999/468/EC
shall apply, in compliance with Article 7 thereof.

The period referred to in Article 5(6) of Decision 1999/468/EC
shall be three months.

Article 26

Accelerated regulatory procedure

The Commission shall be assisted by the Standing

1.
Veterinary Committee established by Decision 68/361/EEC.

2. Where reference is made to this paragraph, the regulatory
procedure laid down in Article 5 of Decision 1999/468/EC
shall apply, in compliance with Article 7 thereof.

The period referred to in Article 5(6) of Decision 1999/468/EC
shall be 15 days.

Article 27

Repeals

Directive 80/217/EEC, as amended by the acts listed in
1.
Annex VII, Part A are hereby repealed as from the date laid
down in Article 29, second subparagraph, without prejudice to
the obligation of the Member States concerning the deadlines
for transposition of the said Directives set out in Annex VII,
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 the correlation table set out in Annex VIII.

2.

Directive 81/859/EEC is hereby repealed.

Article 28

Transitional provisions

1.
By way of derogation from the first subparagraph of
Article 27(1), Annexes I and IV to Directive 80/217/EEC shall
continue to apply for the purposes of this Directive pending
the entry into force of the Decision approving the Diagnostic
Manual referred to in Article 17(3) of this Directive.

2.
Plans to eradicate classical swine fever from feral pigs,
approved in accordance with Article 6a of Directive

(1) OJ L 255, 18.10.1968, p. 23.

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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 slaugh-
terhouse or means of transport, the Member State concerned must notify by means of the Animal Disease Notifi-
cation 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 Member State;

(d) the name of disease;

(e) the number of the outbreak or case;

(f)

the date on which classical swine fever was suspected;

(g) the date of confirmation;

(h) the methods used for confirmation;

(i) whether 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 transport, in addition to the data referred to in

(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 carcasses processed;

(f)

in case of an outbreak, its distance from the nearest pig farm;

(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 carcasses.

3. In case of secondary outbreaks, the information referred to in (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 (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 carcasses

processed;

(b) the results of the tests carried out on samples taken when pigs were killed;

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(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 case of a primary outbreak or a case of classical swine fever in a slaughterhouse or means of transport, the

genetic type of virus responsible for the outbreak or the case;

(f)

in case pigs have been killed in contact holdings or in holdings containing pigs suspected of being infected with
classical swine fever virus, information on:

(cid:151) the date of killing and the number of pigs of each category killed in each holding;

(cid:151) the epidemiological link between the outbreak or case of classical swine fever and each contact holding or the

reasons that have induced to suspect classical swine fever in each suspected holding;

(cid:151) the results of the laboratory tests carried out on the samples taken from the pigs in the holdings and when

they were killed.

In case pigs in contact holdings were not killed, information must be provided on the reasons for this decision.

ANNEX II

Principles and procedures for cleansing and disinfection

1. General principles and procedures:

(a) the cleansing and disinfection operations 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 should be checked before use, as activity of certain disinfectants is diminished by

prolonged storage;

(d) the choice of disinfectants and of procedures for disinfection should 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
technical parameters provided by the manufacturer, such as pressure, minimum

impaired.
temperature and required contact time must be observed;

In particular

(f)

irrespective of the disinfectant used, the following general rules should apply:

(cid:151) thorough soaking of bedding and litter as well as faecal matter with the disinfectant;

(cid:151) 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 otherwise impairing the effective
cleansing and disinfection procedures;

(cid:151) then, further application of disinfectant for a minimum contact time as stipulated in the manufacturers

recommendations;

(g) where washing is carried out with liquids applied under pressure re-contamination of the previously cleansed

parts must be avoided;

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(h) washing, disinfecting or destroying of equipment, installations, articles or compartments likely to be contaminated

should be included;

(i)

following the disinfection procedures re-contamination must be avoided;

(j) cleansing and disinfection required in the framework of this directive must 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:

(cid:151) during the killing of the animals all necessary measures shall be taken to avoid or minimise the dispersion of
classical swine fever virus. This shall include inter alia the installation of temporary disinfection equipment,
supply of protective clothing, showers, decontamination of used equipment, instruments and facilities and the
interruption of power supply to the ventilation;

(cid:151) carcasses of killed animals must be sprayed with disinfectant and removed from the holding for destruction in

covered and leak-proof containers;

(cid:151) as soon as the carcasses of the pigs have been removed for disposal, 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 should be sprayed with disinfectants approved for use in accordance with Article
12;

(cid:151) any tissue or blood which may have been spilled during slaughter or post-mortem or gross contamination of

buildings, yards, utensils, etc. should be carefully collected and disposed of with the carcasses;

(cid:151) the used disinfectant shall remain on the surface for at least 24 hours;

(b) final cleansing and disinfection:

(cid:151) grease and dirt should be removed from all surfaces by the application of a degreasing agent and the surfaces

washed with cold water,

(cid:151) after washing with cold water, further spraying with disinfectant should be applied,

(cid:151) after seven days the premises should be treated with a degreasing agent, rinsed with cold water, sprayed with

disinfectant and rinsed again with cold water.

3. Disinfection of contaminated bedding, manure and slurry:

(a) manure and used bedding should be stacked to heat, sprayed with disinfectant and left for at least 42 days;

(b) slurry should be stored for at least 42 days after the last addition of infective material, unless the competent
authorities authorise a reduced storage period for slurry which was effectively treated in accordance with the
instructions given by the official veterinarian so as to ensure the destruction of the virus.

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ANNEX III

List and duties of national classical swine fever laboratories

1. The national classical swine fever laboratories are as follows:

Belgium

Institut National de recherches vØtØrinaires, 1180 Bruxelles

Denmark

Statens veterin(cid:230)re Institut for Virusforsknig, Lindholm, 4771 Kalvehave

Germany

Bundesforschungsanstalt f(cid:252)r Viruskrankheiten der Tiere, 17498 Insel Riems

Greece

Veterinary Institute of Infectious and parasitic diseases, 15310 Ag. Paraskevi

Spain

Centro de Investigaci(cid:243)n en Sanidad Animal, 28130 Valdeolmos (Madrid)

France

AFSSA-Ploufragan, Zoopole des C(cid:244)tes d’Armor, 22440 Ploufragan

Ireland

Veterinary Research Laboratory, Abbotstown, Castleknock, Dublin 15

Italy

Istituto Zooprofilattico Sperimentale dell’Umbria e delle Marche, 06100 Perugia

Luxembourg

Laboratoire de Medicine Veterinare de l’(cid:201)tat, 1020 Luxembourg

The Netherlands

Instituut voor Veehouderij en Diergezondheid (ID-DLO), 8200 AB Lelystad

Austria

Bundesanstalt f(cid:252)r Virusseuchenbek(cid:228)mpfung bei Haustieren, 1233 Vienna

Portugal

Laborat(cid:243)rio Nacional de Investiga(cid:231)ªo VeterinÆria, 1500 Lisboa

Finland

El(cid:228)inl(cid:228)(cid:228)kint(cid:228) ja elintarvikelaitos, 00231 Helsinki

Sweden

Statens veterin(cid:228)rmedicinska anstalt, 75189 Uppsala

United Kingdom

Central Veterinary Laboratory, New Haw, Weybridge, Surrey KT15 3NB

2. The national classical swine fever laboratories shall be 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 shall be responsible 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 shall control the quality of all diagnostic reagents used in that Member State;

(c) they shall arrange comparative tests periodically;

(d) they shall hold isolates of classical swine fever virus from cases and outbreaks confirmed in that Member State.

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ANNEX IV

Community reference laboratory for classical swine fever

1. The Community reference laboratory for classical swine fever is: Institut f(cid:252)r Virologie, der Tier(cid:228)rztlichen Hochschule

Hanover, B(cid:252)nteweg 17, 30559 Hanover, Germany.

2. The functions and duties of the Community reference laboratory for classical swine fever shall be:

(a) To coordinate, in consultation with the Commission, the methods employed in the Member States for diagnosing

classical swine fever, specifically by:

(cid:151) storing and supplying cell cultures for use in diagnosis;

(cid:151) typing, storing and supplying strains of classical swine fever virus for serological tests and the preparation of

anti-sera;

(cid:151) 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;

(cid:151) building up and holding a classical swine fever virus collection;

(cid:151) organising periodic comparative tests of diagnostic procedures at Community level;

(cid:151) collecting and collating data and information on the methods of diagnosis used and the results of tests carried

out;

(cid:151) characterising isolates of the virus by the most up-to-date methods available to allow greater understanding of

the epizootiology of classical swine fever;

(cid:151) keeping abreast of developments

in classical

swine fever

surveillance, epizootiology and prevention

throughout the world;

(cid:151) retaining expertise on the virus causing classical swine fever and other pertinent viruses to enable rapid

differential diagnosis;

(cid:151) 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.

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Main criteria to be considered for the decision to kill pigs in contact holdings

ANNEX V

Criteria

Decision

For killing

Against killing

Clinical signs suggesting classical swine fever in the
contact holdings

Movements of pigs
from the outbreak to contact
holdings after the likely time of introduction of virus
in the infected holding

Location of contact holdings in an area with a high
density of pigs

Yes

Yes

Yes

No

No

No

Likely shedding of virus from the outbreak before
application of eradication measures

Massive/unknown

Limited

Location of contact holdings within 500 meters (1)
from the outbreak

Proximity of contact holdings
outbreak

to more than one

Number of pigs in the outbreak and/or in contact
holdings

Yes

Yes

High

(1) In case of areas with a very high density of pigs, a longer distance must be considered.

No

No

Low

Main criteria to be considered for the decision to apply emergency vaccination in pig holdings

ANNEX VI

Criteria

Decision

For vaccination

Against vaccination

Number/incidence slope of outbreaks in the previous
10-20 days

High/rising rapidly

Low/shallow or slow rise

Location of holdings where vaccination might be
applied in an area with a high density of pigs

Yes

No

Likelihood of further outbreaks in the area for the next
two months or more

Highly likely

Not likely

Shortage of rendering capacity

Yes

No

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ANNEX VII

PART A

Directive 80/217/EEC and its successive amending acts

(referred to in Article 27)

only Article 2

only concerning the references made in Articles 1 and 2 to the
provisions of Directive 80/217/EEC

only concerning the references made in Article 5 to the
provisions of Directive 80/217/EEC

Directive 80/1101/EEC (1)

Directive 80/1274/EEC (2)

Directive 81/476/EEC (3)

Directive 84/645/EEC (4)

Directive 85/586/EEC (5)

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.

PART B

Deadlines for transposition into National law

Directive

80/217/EEC

80/1101/EEC

80/1274/EEC

81/476/EEC

84/645/EEC

85/586/EEC

87/486/EEC

91/685/EEC

Deadline for transposition

1 July 1981

1 July 1981

31 March 1985

1 January 1986

31 December 1987

1 July 1992

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ANNEX VIII

Correlation table

This Directive

Directive 80/217/EEC

Article 1

Article 1

Article 2(a), (b), (e), (f), (m), (n), (o), (q)

Article 2(a), (e), (g), (h), (I), (j), (k), (m)

Article 2(c), (d), (g), (h), (i), (j), (k), (l), (p), (r), (s), (t), (u),
(v), (w)

(cid:151)

Article 3(1)

Article 3(2) and (3)

Article 4(1) and (2)

Article 4(3)

Article 4(4)

Article 3

Article 12

Article 4(1)

(cid:151)

Article 4(2)

Article 5(1), (a), (c), (d), (f), (g), (i)

Article 5(1), except the seventh indent

Article 5(1) (b), (e), (h) and (2)

Article 6

(cid:151)

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 second sentence in the
second subparagraph (b)

(cid:151)

(cid:151)

Article 8, except the subparagraph and sentence above

Article 7

Article 9(1) except (g) and (h)

Article 9(1) (g) and (h)

Article 9(2), (3) and (4)

Article 9(1)

(cid:151)

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 11(1) and (2)

Article 11(3)

Article 12(1)

Article 12(2)

(cid:151)

Article 9(5)

Article 9(6)

Article 9(7)

Article 12

(cid:151)

Article 13, except (1)(b)

Article 5(1), seventh indent

Article 13(1)(b)

Article 14

Article 15(1)

(cid:151)

(cid:151)

Article 6a(1)

Article 15(2)(a) and (b), fifth and eighth indents

(cid:151)

Article 15(2)(b), except the fifth and eighth indents

Article 6a(2)

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This Directive

Directive 80/217/EEC

Article 15(2)(c)

Article 15(2)(d) and (3)

Article 6a(2a)

(cid:151)

Article 16(1), except the fourth subparagraph, and (2)

Article 6a(3) and (4)

Article 16(3)(b), (c), (g), (j), (k), (l), (n)

Article 6a(5)

Article 16(1), fourth subparagraph, (3) (a), (d), (e), (f), (h),
(i), (o), (p), (q) and (4)

(cid:151)

Article 17(1), (2)

Article 17(3), (4) and (5)

Article 18

Article 11

(cid:151)

Article 14(1)(a), 1(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), (7), (8) and (9)

Article 20

Article 21

(cid:151)

(cid:151)

Article 14(a)

Article 22(1), (2) and (3)

Article 14(b)(1), (2), (4)

Article 23

Article 24

Article 25

Article 26

Article 27

Article 28

Article 29

Article 30

Article 31

Annex I

Annex II, point 1, point 2, first and second indents, and
point 3(b)

(cid:151)

(cid:151)

Article 16

Article 16(a)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

Article 20

(cid:151)

(cid:151)

Annex II, points 2, except the first and second indents and
3(b)

Annex V

Annex III, points 1 and 3

Annex III, point 2

Annex IV

Annex V

Annex VI

Annex VII

Annex II

(cid:151)

Annex VI

(cid:151)

(cid:151)

(cid:151)