Council Directive 2003/85/EC of 29 September 2003 on Community measures for the control of foot-and-mouth disease repealing Directive 85/511/EEC and Decisions 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC (Text with EEA relevance.)
Date: 2003-09-29
Institutions: Council of the European Union
Subjects: epidemiology, foot-and-mouth disease, vaccination, veterinary inspection

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I

(Acts whose publication is obligatory)

COUNCIL DIRECTIVE 2003/85/EC

of 29 September 2003

on Community measures for the control of foot-and-mouth disease repealing Directive 85/511/
EEC and Decisions 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

(3)

Having regard to the Treaty establishing the European Com-
munity, and in particular Article 37(3) thereof,

Having regard to the proposal from the Commission (1),

Having regard to the Opinion of the European Parliament (2),

Foot-and-mouth disease is a compulsorily notifiable
disease and outbreaks must be notified by the Member
State affected to the Commission and other Member
States, in accordance with Council Directive 82/894/
EEC of 21 December 1982, on the notification of animal
diseases within the Community (5).

Having regard to the Opinion of the European Economic and
Social Committee (3),

(4)

Having regard to the Opinion of the Committee of the
Regions (4),

Whereas:

The Community measures for the control of foot-and-
mouth disease are laid down in Council Directive 85/
511/EEC of 18 November 1985 introducing Community
measures for the control of foot-and-mouth disease (6).
That Directive has been significantly amended on many
occasions. Now that new amendments are being made
to the said Directive, it is desirable, in order to clarify
matters, that the provisions in question should be recast.

(1) One of the Community’s tasks in the veterinary field is
to improve the state of health of livestock, thereby
increasing the profitability of livestock farming and
facilitating trade in animals and animal products. At the
same time the Community is also a Community of
values, and its policies to combat animal diseases must
not be based purely on commercial interests but must
also take genuine account of ethical principles.

(2)

Foot-and-mouth disease is a highly contagious viral
disease of biungulates. Although foot-and-mouth disease
has no public health importance, due to its exceptional
economic importance, it is on the top of list A diseases
of the Office International des Epizooties (OIE).

(1) Proposal of 18 December 2002.
(2) Opinion delivered on 15 May 2003 (not yet published in the

Official Journal).

(3) Opinion delivered on 14 May 2003 (not yet published in the

Official Journal).

(5)

Following the adoption of Council Directive 90/423/
EEC of 26 June 1990 amending Directive 85/511/
EEC, Directive 64/432/EEC on animal health problems
affecting intra-Community trade in bovine animals and
swine and Directive 72/462/EEC on health and vet-
erinary inspection problems upon importation of bovine
animals and swine and fresh meat or meat products
from third countries (7), prophylactic vaccination against
foot-and-mouth disease was prohibited throughout the
Community as of 1 January 1992.

(5) 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).
(6) OJ L 315, 26.11.1985, p. 11. Directive as last amended by the

(4) Opinion delivered on 2 July 2003 (not yet published in the

Official Journal).

2003 Act of Accession.
(7) OJ L 224, 18.8.1990, p. 13.

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(6)

(7)

(8)

(9)

Preventive measures are necessary to avoid the incursion
of foot-and-mouth disease into the Community and into
Community livestock from neighbouring countries or
through the introduction into the Community of live
animals and products of animal origin. There is no
indication that any of the outbreaks of foot-and-mouth
disease reported since the prohibition of prophylactic
vaccination can be attributed to imports in accordance
with Community legislation and subject to veterinary
checks at border inspection posts, established in accord-
ance with Council Directive 91/496/EEC of 15 July 1991
laying down the principles governing the organisation of
veterinary checks on animals entering the Community
from third countries (1), and Council Directive 90/675/
EEC of 10 December 1990 laying down the principles
governing the organisation of veterinary checks on
from third
products
countries (2).

the Community

entering

Nevertheless, strict application of the Community rules
on imports of animal products aimed at reducing risks
should be strongly emphasised, if for no other reason
than the increase in trade and movement of persons
worldwide. The Member States should ensure that this
legislation is implemented in its entirety and make
enough personnel and resources available to provide
strict controls on the external borders.

In addition, the European Parliament’s Temporary Com-
mittee on Foot-and-Mouth Disease found that, in prac-
tice, border inspections are failing to prevent significant
quantities of meat and meat products from entering the
Community illegally.

Under the conditions of the single market and the overall
satisfactory health status of livestock herds, the exchange
of animals and animal products has increased substan-
tially and certain regions of the Community have densely
populated livestock areas.

(10) The foot-and-mouth disease epidemic in certain Member
States in 2001 demonstrated that due to intensive
movement of and trade in animals susceptible to foot-
and-mouth disease, an outbreak can quickly take on
epizootic proportions, causing disturbances on a scale
liable to reduce sharply the profitability of farming of
animals of susceptible species and other parts of the
rural economy and also requiring substantial financial
resources to compensate farmers and the application of
control measures.

reinforced

the Community

(11) During the 2001 foot-and-mouth disease crisis, the
Commission
control
measures for foot-and-mouth disease laid down in
Directive 85/511/EEC by adopting protective measures
in accordance with Council Directive 90/425/EEC of
26 June 1990 concerning veterinary and zootechnical
checks applicable in intra-Community trade in certain
live animals and products with a view to the completion
of the internal market (3), and Council Directive 89/662/
EEC of 11 December 1989 concerning veterinary checks
in intra-Community trade with a view to the completion
of the internal market (4).

(12)

In 2001, the Commission also adopted Decisions on the
conditions for the use of emergency vaccination in
accordance with Directive 85/511/EEC. Those con-
ditions were laid down taking account of the recommen-
dations contained in the report of the Scientific Com-
mittee on Animal Health and Animal Welfare on the
strategy for emergency vaccination against foot-and-
mouth disease of 1999.

(13) This Directive should take into account the report of
expert groups from Member States on a review of
Community legislation on foot-and-mouth disease of
1998, which reflects the experience gained by Member
States during the classical swine fever epidemic in 1997,
and the conclusions of the International Conference on
the Prevention and Control of Foot-and-Mouth Disease
held in Brussels in December 2001.

(14) The Resolution of 17 December 2002 of the European
Parliament on the foot-and-mouth disease epidemic in
2001 in the European Union (5), based on the con-
clusions of the Temporary Committee on Foot-and-
Mouth Disease of the European Parliament should be
taken into account in this Directive.

(15) The recommendations in the Report of the Thirtieth
Session of the European Commission for the Control of
Foot-and-Mouth Disease of the Food and Agriculture
Organisation on minimum standards for laboratories
working with foot-and-mouth virus in vitro and in vivo
of 1993, should be taken into account.

(16) This Directive should also take into account the changes
made in the Animal Health Code and the Manual of
Standards for Diagnostic Tests and Vaccines of the OIE
(OIE Manual).

(1) OJ L 268, 24.9.1991, p. 56. Directive as last amended by Directive

96/43/EC (OJ L 162, 1.7.1996, p. 1).

(3) OJ L 224, 18.8.1990, p. 29. Directive as last amended by Directive
2002/33/EC of the European Parliament and of the Council (OJ
L 315, 19.11.2002, p. 149).

(4) OJ L 395, 30.12.1989, p. 13. Directive as last amended by

(2) OJ L 373, 31.12.1990, p. 1. Directive as last amended by Directive

Directive 92/118/EEC (OJ L 62, 15.3.1993, p. 49).

96/43/EC (OJ L 162, 1.7.1996, p. 1).

(5) OJ C 21 E, 24.1.2002, p. 339.

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(17)

(18)

In order to ensure early detection of any possible
outbreak of foot-and-mouth disease, legal provisions are
necessary to oblige those in contact with animals of
susceptible species to notify any suspect case to the
competent authorities. Regular inspections should be
introduced in the Member States to ensure that farmers
are in fact familiar with and are applying the general
rules on disease control and biosecurity.

It is necessary that action be taken as soon as the
presence of the foot-and-mouth disease is suspected so
that immediate and effective control measures can be
implemented once its presence is confirmed. Such
measures should be modulated by the competent auth-
orities depending on the epidemiological situation in the
Member State concerned. However, the measures should
also be reinforced by specific protection measures
established in accordance with Community legislation.

(19) A rapid and detailed diagnosis of

the disease and
identification of the relevant virus should be carried out
under the auspices of a network of national laboratories
in the Member States. Where necessary, cooperation
between the national laboratories should be ensured by
a Community reference laboratory designated by the
Commission in accordance with the procedure of the
Standing Committee on the Food Chain and Animal
Health established by Regulation (EC) No 178/2002 of
the European Parliament and the Council of 28 January
2002 laying down the general principles and require-
ments of food law, establishing the European Food
Safety Authority and laying down procedures in matters
of food safety (1).

(20) With regard to the differential laboratory diagnosis for
foot-and-mouth disease, account should be taken of
Commission Decision 2000/428/EC of 4 July 2000
establishing diagnostic procedures, sampling methods
and criteria for the evaluation of the results of laboratory
tests for the confirmation and differential diagnosis of
swine vesicular disease (2).

(21) Community measures for the control of foot-and-mouth
disease should be based first of all on depopulation of the
infected herd. The killing of infected and contaminated
animals of susceptible species should be carried out
without delay in accordance with Council Directive 93/
119/EEC of 22 December 1993 on the protection of
animals at the time of slaughter or killing (3). Where
possible the processing of the carcasses of dead or killed
animals should be carried out
in accordance with
Regulation (EC) No 1774/2002 of the European Parlia-
ment and of the Council of 3 October 2002 laying down

(1) OJ L 31, 1.2.2002, p. 1.
(2) OJ L 167, 7.7.2000, p. 22.
(3) OJ L 340, 31.12.1993, p. 21.

health rules concerning animal by-products not intended
for human consumption (4).

(22)

It is necessary to integrate public health and environment
protection aspects in the event of a foot-and-mouth
disease outbreak,
in particular by establishing close
cooperation between the veterinary health and environ-
ment competent authorities. Council Directive 96/61/EC
of 24 September 1996 concerning integrated pollution
prevention and control (5)
requires an integrated
environmental permit for installations for the disposal
or recycling of animal carcasses and animal waste with
a specified treatment capacity. Unnecessary risks from
burning animal carcasses on pyres or burying them at
mass burial sites should be avoided.

(23)

It is necessary to prevent any spread of the disease as
soon as an outbreak occurs by carefully monitoring
movements of animals and the use of products liable to
be contaminated, and where appropriate, in particular
in densely populated livestock areas, by emergency
vaccination.

(24) The action taken to control the foot-and-mouth diesease
epidemics which struck certain Member States in 2001
has shown that international and Community rules and
the ensuing practices have not taken sufficient account
of the possibility offered by the use of emergency
vaccination and subsequent tests to detect infected
animals in a vaccinated population. Too much import-
ance was attached to the trade-policy aspects, with the
result that protective vaccination was not carried out
even when it had been authorised.

(25) Various strategies are available for controlling foot-and-
mouth disease. In the event of an epidemic, the choice
of strategy to control the disease should likewise take
account of which strategy causes the least possible
economic damage for non-agricultural sectors of the
economy.

(26) By means of emergency vaccination without subsequent
killing of the vaccinated animals the number of animals
to be killed for disease control purposes may be reduced
significantly. Appropriate testing should thereafter sub-
stantiate the absence of infection.

(27) Cleansing and disinfection should be an integral part of
the Community control policy for foot-and-mouth
disease. The use of disinfectants should be in compliance
with Directive 98/8/EC of the European Parliament and
of the Council of 16 February 1998 concerning the
placing of biocidal products on the market (6).

(4) OJ L 273, 10.10.2002, p. 1. Regulation as last amended by
Commission Regulation (EC) No 808/2003 (OJ L 117, 13.5.2003,
p. 1).

(5) OJ L 257, 10.10.1996, p. 26.
(6) OJ L 123, 24.4.1998, p. 1.

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(28) Semen, ova and embryos collected from animals of
susceptible species infected with the foot-and-mouth
disease virus may contribute to the spread of the disease
and should therefore be subject to restrictions in addition
to those animal health conditions laid down for intra-
Community trade in the following Directives:

(30) With regard to animal health, the conditions governing
placing on the market, trade and imports into the
Community of animal products intended for human
consumption are laid down in the following Directives:

— Council Directive 88/407/EEC of 14 June 1988
laying down the animal health requirements appli-
cable to intra-Community trade in and imports of
deep-frozen semen of domestic animals of the
bovine species (1);

— Council Directive 89/556/EEC of 25 September
1989 on animal health conditions governing intra-
Community trade in and importations from third
countries of embryos of domestic animals of the
bovine species (2);

— Council Directive 92/65/EEC of 13 July 1992
laying down animal health requirements governing
trade in and imports into the Community of
animals, semen, ova and embryos not subject to
animal health requirements laid down in specific
Community rules referred to in Annex A (I) to
Directive 90/425/EEC (3).

(29)

In the event of an outbreak it may be necessary to
apply control measures not only to infected animals of
susceptible species, but also to contaminated animals of
species not susceptible to the disease which may be
mechanical vectors for the virus. During the 2001
foot-and-mouth disease epidemic, restrictions were also
applied on the movement of equidae coming from
holdings keeping animals of susceptible species or
neighbouring such holdings and specific certification, in
addition to the requirements of Council Directive 90/
426/EEC of 26 June 1990 on animal health conditions
governing the movement and import
from third
countries of equidae (4), was required in order to control
trade in equidae from Member States affected by foot-
and-mouth disease.

— Council Directive 64/433/EEC of 26 June 1964 on
health problems affecting intra-Community trade
in fresh meat (5);

— Council Directive 77/99/EEC of 21 December 1976
on health problems affecting the intra-Community
trade of meat products origin (6);

— Council Directive 80/215/EEC of 22 January 1980
on animal health problems affecting intra-Com-
munity trade in meat products (7);

— Council Directive 91/495/EEC of 27 November
1990 concerning public health and animal health
problems affecting the production and placing on
the market of rabbit meat and farmed game
meat (8);

— Council Directive 94/65/EC of 14 December 1994
laying down the requirements for the production
and placing on the market of minced meat and
meat preparations (9),

— Council Directive 2002/99/EC of 16 December
2002 laying down the animal health rules govern-
ing the production, processing, distribution and
introduction of products of animal origin for
human consumption (10).

(31) Those Directives are now in the process of being
replaced. In order to ease reference, the treatment of
meat and meat products from animals of susceptible
species, required to ensure the destruction of possible
foot-and-mouth disease virus,
specified in the
Annexes VII to IX of this Directive which are based on
those Directives and comply with recommendations of
the OIE.

is

(5) OJ L 121, 29.7.1964, p. 2012/64. Directive as last amended by

Directive 95/23/EC (OJ L 243, 11.10.1995, p. 7).

(1) OJ L 194, 22.7.1988, p. 10. Directive as last amended by the

(6) OJ L 26, 31.1.1977, p. 85. Directive as last amended by Directive

2003 Act of Accession.

(2) OJ L 302, 19.10.1989, p. 1. Directive as last amended by
Commission Decision 94/113/EC (OJ L 53, 24.2.1994, p. 23).
(3) OJ L 268, 14.9.1992, p. 54. Directive as last amended by
Commission Regulation (EC) No 1282/2002 (OJ L 187,
16.7.2002, p. 13).

(4) OJ L 224, 18.8.1990, p. 42. Directive as last amended by
Commission Decision 2002/160/EC (OJ L 53, 23.2.2002, p. 37).

97/76/EC (OJ L 10, 16.1.1998, p. 25).

(7) OJ L 47, 21.2.1980, p. 4. Directive as last amended by the 2003

Act of Accession.

(8) OJ L 268, 24.9.1991, p. 41. Directive as last amended by

Directive 94/65/EC (OJ L 368, 31.12.1994, p. 10).

(9) OJ L 368, 31.12.1994, p. 10.
(10) OJ L 18, 23.1.2003, p. 11. Directive as last amended by the

2003 Act of Accession.

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(32) The animal health rules governing the production,
processing, distribution and introduction of products of
animal origin for human consumption are laid down in
Council Directive 2002/99/EC of 16 December 2002 (1).

(33) Council Directive 92/46/EEC of 16 June 1992 laying
down the health rules for the production and placing on
the market of raw milk, heat-treated milk and milk-
based products (2) provides for the treatment of milk
from animals kept within the perimeters of surveillance
zones established in accordance with Community con-
trol measures for foot-and-mouth disease. The require-
ments of that Directive are not sufficient, as they do not
provide for treatment of milk from protection zones
and from vaccinated animals. In addition, the treatment
for milk for human consumption provided for in that
Directive exceeds the requirements of the code of the
OIE on destruction of foot-and-mouth disease virus in
milk and results in logistic problems in the disposal of
substantial quantities of milk refused by dairy plants.
More detailed provisions on the collection and transport
of milk from animals of susceptible species in areas
subject to control measures for foot-and-mouth disease
should be included in this Directive. The treatment of
milk and milk products specified in Annex IX of this
Directive complies with recommendations of the OIE
for the destruction of possible foot-and-mouth disease
virus in milk and milk products. Directive 92/46/EEC
should therefore be amended accordingly.

(34) With regard to products of animal origin account
should be taken of Council Directive 92/118/EEC of
17 December 1992 laying down animal health and
public health requirements governing trade in and
imports into the Community of products not subject to
the said requirements laid down in specific Community
rules referred to in Annex A (I) to Directive 89/662/EEC
and, as regards pathogens, to Directive 90/425/EEC (3).
Certain provisions of Directive 92/118/EEC have been
included in Regulation (EC) No 1774/2002.

(36) Directive 64/432/EEC provides for the definition of
regions. Commission Decision
2000/807/EC of
11 December 2000 laying down the codified form and
the codes for the notification of animal diseases pursuant
to Council Directive 82/894/EEC (4) specifies adminis-
trative areas in Member States related to disease control
measures and disease notification.

(37) To guard against emergencies, the Community has,
in accordance with Council Decision 91/666/EEC of
11 December 1991 establishing Community reserves of
foot-and-mouth disease vaccines (5), established reserves
of
inactivated foot-and-mouth disease virus antigen
stored at designated premises, and the Community
antigen and vaccine bank. Transparent and efficient
procedures should be established to guarantee access to
the antigen without undue delay. In addition, certain
Member States have established and maintain national
antigen and vaccine banks.

(38) Directive 2001/82/EC of the European Parliament and
of the Council of 6 November 2001 on the Community
code relating to veterinary medicinal products (6)
requires that, with only minor exceptions, all veterinary
medicinal products that are placed on the market within
the Community hold a marketing authorisation.
In
addition, that Directive lays down the criteria for the
granting of a marketing authorisation for veterinary
medicinal products, including immunological veterinary
medicinal products. That Directive authorises Member
States to permit release onto their market of a product
without a marketing authorisation in the event of a
serious epidemic under certain conditions. Foot-and-
mouth disease has the potential for a serious epidemic.
Given the rapid variation of antigen required to produce
an effective protection of animals of susceptible species
in case of emergency, vaccines against foot-and-mouth
disease qualify for the derogation provided for in that
Directive.

(35) The application of the principle of regionalisation should
allow the implementation of strict control measures,
including emergency vaccination, in a defined part of the
Community without endangering general Community
interests. Dairy and meat products from vaccinated
animals may be placed on the market in accordance with
the relevant Community legislation and this Directive in
particular.

(39) The Community Reference Laboratory should advise the
Commission and the Member States on the need for
vaccines and antigens, in particular where virus strains
are detected against which the vaccines produced on the
basis of those antigens stored in the Community antigen
and vaccine bank do not provide sufficient protection.

(1) OJ L 18, 23.1.2003, p. 11.
(2) OJ L 268, 14.9.1992, p. 1. Directive as last amended by Directive

94/71/EC (OJ L 368, 31.12.1994, p. 33).

(4) OJ L 326, 22.12.2000, p. 80. Decision as last amended by

Decision 2002/807/EC (OJ L 279, 17.10.2002, p. 50).

(5) OJ L 368, 21.12.1991, p. 21. Decision as last amended by

(3) OJ L 62, 15.3.1993, p. 49. Directive as last amended by
Commission Decision 2003/42/EC (OJ L 13, 18.1.2003, p. 24).

Decision 2001/181/EC (OJ L 66, 8.3.2001, p. 39).

(6) OJ L 311, 28.11.2001, p. 1.

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(40) As a matter of precaution, in relation to the risks of a
deliberate release of foot-and-mouth disease virus,
it
is appropriate to apply specific procedures to the
procurement of antigens for the Community antigen
and vaccine bank and to the publication of certain
details relating to disease control measures.

(44)

(41) The presence of an entirely non-immune population of
susceptible livestock in Member States requires perma-
nent disease-awareness and preparedness. The need for
detailed contingency plans has been proven once more
during the 2001 foot-and-mouth disease epidemic. At
present, all Member States have contingency plans
approved by Commission Decision 93/455/EEC of
23 July 1993 approving certain contingency plans for
the control of foot-and-mouth-disease (1). Such contin-
gency plans should be reviewed regularly, among other
things,
in the light of the results of real-time alert
exercises carried out in the Member States, the experi-
ence of the 2001 epidemic and in order to include
measures to protect the environment. Member States
should be encouraged to organise and carry out such
exercises in close cooperation and across borders. The
Commission should be encouraged, in cooperation with
the Member States, to make provision for the setting-up
of technical assistance which could be made available to
Member States affected by an epidemic.

(42)

In order to protect Community livestock and based on
risk assessment, provision should be made to assist
neighbouring third countries infected by or at risk of
foot-and-mouth disease,
in particular as regards the
emergency supply of antigen or vaccines. However, such
provisions should apply without prejudice to agreements
concluded between the third country concerned and the
Community on access to the Community antigen and
vaccine bank.

(43) Council Decision 90/424/EEC of 26 June 1990 on
expenditure in the veterinary field (2), applies in the
event of the occurrence of foot-and-mouth disease and
provides for Community aid to be granted to reference
laboratories and antigen and vaccine banks. Any Com-
munity compensation paid to Member States for finan-
cial expenditures relating to control measures in the case
of outbreaks of
foot-and-mouth disease, should be
subject to scrutiny regarding compliance with at least
the minimum requirements laid down in this Directive.

In order to ensure close cooperation between the
Member States and the Commission in controlling foot-
and-mouth disease and taking into account the nature
of the disease, the Commission should be empowered to
modify and adapt certain technical aspects of the control
measures. Where necessary, the Commission should
base any such modifications or adaptations on the
results of a veterinary inspection mission carried out in
accordance with Commission Decision 98/139/EC of
4 February 1998 laying down certain detailed rules
concerning on-the-spot checks carried out in the vet-
erinary field by Commission experts in the Member
States (3).

(45) The Member States should lay down rules on penalties
applicable to infringements of the provisions of this
Directive and ensure that they are implemented. Those
penalties must be effective, proportionate and dissuasive.

(46)

In accordance with the principle of proportionality, it is
necessary and appropriate for the achievement of the
basic objective of maintaining and, in the event of an
outbreak, of quick recovery of a foot-and-mouth disease
and infection-free status of all Member States, to lay
down rules on the measures to increase disease prepared-
ness and to control outbreaks as quickly as possible, if
necessary by emergency vaccination, and to limit the
adverse effects on the production of and trade in
livestock and products of animal origin. This Directive
does not go beyond what is necessary in order to achieve
the objectives pursued in accordance with the third
paragraph of Article 5 of the Treaty.

(47) The measures necessary for the implementation of this
Directive should be adopted in accordance with Council
Decision 1999/468/EC of 28 June 1999 laying down
the procedures for the exercise of implementing powers
conferred on the Commission (4),

HAS ADOPTED THIS DIRECTIVE:

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter and scope

1.

(a)

This Directive sets out:

the minimum control measures to be applied in the event
of an outbreak of foot-and-mouth disease of whatever
type of virus;

(1) OJ L 213, 24.8.1993, p. 20. Decision as last amended by Decision

2001/96/EC (OJ L 35, 6.2.2001, p. 52).

(2) OJ L 224, 18.8.1990, p. 19. Decision as last amended by Decision

2001/572/EC (OJ L 203, 28.7.2001, p. 16).

(3) OJ L 38, 12.2.1998, p. 10.
(4) OJ L 184, 17.7.1999, p. 23.

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(b)

certain preventative measures aimed at increasing aware-
ness and preparedness of the competent authorities and
the farming community for foot-and-mouth disease.

2. Member States shall remain free to take more stringent
action in the field covered by this Directive.

Article 2

Definitions

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

(a)

‘animal of a susceptible species’ means any domestic or
wild animal of the suborders Ruminantia, Suina, and
Tylopoda of the order Artiodactyla;

specific measures, notably

For
in application of
Article 1(2), Article 15 and Article 85(2), other animals,
such as for example of the order Rodentia or Proboscidae,
may be considered susceptible to foot-and-mouth disease
in accordance with scientific evidence.

(b)

‘holding’ means any agricultural or other premises, includ-
ing circuses, located in the national territory of a Member
State where animals of susceptible species are being bred
or kept on a permanent or temporary basis.

However, for the purpose of Article 10(l) this definition
include living areas for humans on such
does not
premises, unless animals of susceptible species, including
those referred to in Article 85(2), are kept on a permanent
or temporary basis therein, slaughterhouses, means of
transport, border inspection posts or fenced areas where
animals of susceptible species are kept and may be
hunted, if such fenced areas are of a size which makes the
measures provided for in Article 10 inapplicable;

(c)

(d)

(e)

‘herd’ means an animal or group of animals kept on a
holding as an epidemiological unit; if more than one herd
is kept on a holding, each of these herds shall form a
distinct unit and shall have the same health status;

‘owner’ means any person or persons, either natural or
legal, having ownership of an animal of a susceptible
species, or charged with keeping such animals, whether
or not for financial reward;

‘competent authority’ means the authority of a Member
State competent to carry out veterinary or zootechnical
checks or any authority to which it has delegated that
competence;

(f)

(g)

(h)

(i)

(j)

(k)

‘official veterinarian’ means the veterinarian designated
by the competent authority of the Member State;

‘authorisation’ means a written authorisation given by the
competent authorities, of which the necessary copies
must be available for subsequent inspections in accord-
ance with the appropriate legislation in the Member State
concerned;

‘incubation period’ means the length of the time between
infection and the occurrence of clinical signs of foot-and-
mouth disease. Namely, for the purposes of this Directive,
14 days for bovine and porcine animals, and 21 days for
ovine and caprine animals and any other animal of
susceptible species;

‘animal suspected of being infected’ means any animal of
a susceptible species exhibiting clinical symptoms or
showing post-mortem lesions or reactions to laboratory
tests which are such that the presence of foot-and-mouth
disease may reasonably be suspected;

‘animal suspected of being contaminated’ means any
animal of a susceptible species which, according to the
epidemiological information collected, may have been
directly or indirectly exposed to the foot-and-mouth
disease virus;

‘case of
infected
foot-and-mouth disease’ or ‘animal
with foot-and-mouth disease’ means any animal of a
susceptible species or carcass of such animal in which
foot-and-mouth disease has been officially confirmed,
taking into account the definitions in Annex I:

— either on clinical symptoms or post-mortem lesions
consistent with foot-and-mouth disease have been
officially confirmed, or

— as the result of a laboratory examination carried out

in accordance with Annex XIII;

(l)

‘outbreak of foot-and-mouth disease’ means a holding
where animals of susceptible species are kept, which
meets one or more of the criteria set out in Annex I;

(m)

‘primary outbreak’ means the outbreak within the mean-
ing of Article 2(d) of Directive 82/894/EEC;

(n)

(o)

(p)

‘killing’ means the killing of animals within the meaning
of Article 2(6) of Directive 93/119/EEC;

‘emergency slaughter’ means the slaughter in emergency
cases within the meaning of Article 2(7) of Directive 93/
119/EEC of animals which on the basis of epidemiological
data or clinical diagnosis or results of laboratory testing
are not considered infected or contaminated with foot-
and mouth disease virus, including slaughter for reasons
of animal welfare;

‘processing’ means one of the treatments for high risk
material laid down in Regulation (EC) No 1774/2002,
and any implementing legislation thereof, applied in such
a way as to avoid the risk of spread of foot-and-mouth
disease virus;

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(q)

(r)

(s)

(t)

‘regionalisation’ means the delimitation of a restricted
zone in which restrictions are applied on the movements
of or trade in certain animals or animal products as
provided for in Article 45 in order to prevent the spread
of foot-and-mouth disease into the free zone where no
restrictions are applied in accordance with this Directive;

‘region’ means an area as defined in Article 2(2) (p) of
Directive 64/432/EEC;

CHAPTER II

CONTROL OF OUTBREAKS OF FOOT-AND-MOUTH
DISEASE

SECTION 1

NOTIFICATION

Article 3

‘sub-region’ means an area specified in the Annex to
Decision 2000/807/EC;

Foot-and-mouth disease notification

‘Community antigen and vaccine bank’ means appropri-
ate premises designated in accordance with this Directive
for the storage of Community reserves of both concen-
trated inactivated antigen of the foot-and-mouth disease
virus for the production of
foot-and-mouth disease
vaccines and veterinary immunological products (vac-
cines) reconstituted from such antigens and authorised in
accordance with Directive 2001/82/EC of the European
Parliament and of the Council of 6 November 2001 on
the Community code relating to veterinary medicinal
products (1);

(u)

‘emergency vaccination’ means vaccination in accordance
with Article 50(1);

(v)

(w)

(x)

(y)

‘protective vaccination’ means emergency vaccination
carried out on holdings in a designated area in order to
protect animals of susceptible species within this area
against airborne spread or spread through fomites of
foot-and-mouth disease virus and where the animals are
intended to be kept alive following vaccination;

‘suppressive vaccination’ means emergency vaccination
which is carried out exclusively in conjunction with a
stamping-out policy in a holding or area where there is
an urgent need to reduce the amount of foot-and-mouth
disease virus circulating and to reduce the risk of it
spreading beyond the perimeters of the holding or the
area and where the animals are intended to be destroyed
following vaccination;

‘wild animal’ means an animal of a susceptible species
living outside holdings as defined in Article 2(b) or
premises referred to in Articles 15 and 16;

‘primary case of foot-and-mouth disease in wild animals’
means any case of
foot-and-mouth disease which is
detected in a wild animal in an area in which no measures
are in place in accordance with Article 85(3) or (4).

(1) OJ L 311, 28.11.2001, p. 1.

1. Member States shall ensure that:

(a)

(b)

(c)

foot-and-mouth disease is listed by the competent auth-
ority as a compulsorily notifiable disease;

and

any person attending

the owner
animals,
accompanying animals during transport or looking after
animals shall be obliged to notify without delay to the
competent authority or the official veterinarian the
presence or suspected presence of foot-and-mouth disease
and keep animals infected with foot-and-mouth disease
or animals suspected of being infected, away from places
where other animals of susceptible species are at risk of
being infected or contaminated with the foot-and-mouth
disease virus;

veterinary practitioners, official veterinarians, senior staff
of veterinary or other official or private laboratories and
any person with a occupational relation to animals of
susceptible species or products derived from such animals
shall be obliged to notify without delay to the competent
authority any knowledge of the presence or suspected
presence of foot-and-mouth disease they have obtained
prior to official intervention within the framework of this
Directive.

2. Without prejudice to existing Community legislation on
notification of outbreaks of animal disease, the Member State
on whose territory an outbreak of foot-and-mouth disease or
a primary case of foot-and-mouth disease in wild animals is
confirmed shall give notification of the disease and provide
information and written reports to the Commission and the
other Member States in accordance with Annex II.

SECTION 2

MEASURES IN CASE OF SUSPICION OF AN OUTBREAK OF
FOOT-AND-MOUTH DISEASE

Article 4

Measures in case of suspicion of an outbreak of foot-and-
mouth disease

1. Member States shall ensure that the measures provided
for in paragraphs 2 and 3 are carried out where a holding
contains one or more animals suspected of being infected or
contaminated.

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The competent authority shall

2.
immediately activate
official investigation arrangements under its supervision to
confirm or rule out the presence of the foot-and-mouth disease
and, in particular, have the necessary samples taken for the
laboratory examinations required to confirm an outbreak in
accordance with the definition of outbreak in Annex I.

(a) movement from the holding of meat or carcasses, meat
products, milk or milk products, semen, ova or embryos
of animals of susceptible species or of animal feed,
utensils, objects or other substance, such as wool, hides
and skins, bristles or animal waste, slurry, manure or
anything liable to transmit foot-and-mouth disease virus;

3.
The competent authority shall place the holding referred
to in paragraph 1 under official surveillance as soon as the
suspected infection is notified and shall in particular ensure
that:

(a)

(b)

(c)

a census is made of all categories of animals on the
holding and that, in respect of each category of animals
of susceptible species, the number of animals that are
already dead and the animals suspected of being infected
or of being contaminated, is recorded;

the census as referred to in point (a) is kept up to date to
take account of those animals of susceptible species born
or dying during the period of suspicion. Such information
is produced by the owner on request of the competent
authority and is checked by that authority at each visit;

all stocks of milk, milk products, meat, meat products,
carcasses, hides and skins, wool, semen, embryos, ova,
slurry, manure as well as animal feed and litter on the
holding are recorded and those records are maintained;

(d) no animals of susceptible species enter or leave the
holding, except in cases of holdings consisting of different
epidemiological production units referred to in Article 18,
and that all animals of susceptible species on the holding
are kept in their living quarters or another place where
they can be isolated;

(e)

(f)

(g)

appropriate means of disinfection are used at
the
entrances and exits of buildings or places housing animals
of susceptible species and of the holding itself;

an epidemiological inquiry is carried out in accordance
with Article 13;

to facilitate the epidemiological inquiry, the necessary
samples shall be taken for laboratory testing in accord-
ance with point 2.1.1.1 of Annex III.

(b) movement of animals of species not susceptible to foot-

and-mouth disease;

(c) movement of persons onto or out of the holding;

(d) movement of vehicles onto or out of the holding.

2.
By way of derogation from the prohibition in point (a)
of paragraph 1, the competent authority may in the event of
difficulties in storing the milk on the holding either order that
the milk shall be destroyed on the holding, or authorise the
milk to be transported under veterinary supervision and only
by means of transport suitably equipped to ensure no risk of
spreading foot-and-mouth disease virus from the holding to
the nearest possible place for disposal or treatment ensuring
destruction of the foot-and-mouth disease virus.

By way of derogation from the prohibitions provided for
3.
in points (b),
(c) and (d) of paragraph 1, the competent
authority may authorise such movements onto and off the
holding subject to all conditions necessary in order to avoid
the spread of foot-and-mouth disease virus.

Article 6

Extension of measures to other holdings

1.
The competent authority shall extend the measures
provided for in Articles 4 and 5 to other holdings where their
location, their construction and layout, or contacts with
animals from the holding referred to in Article 4, give reason
to suspect contamination.

2.
The competent authority shall apply at least the measures
provided for in Articles 4 and 5(1) to premises or means of
transport referred to in Article 16 should the presence of
animals of susceptible species give reason to suspect infection
or contamination with the foot-and-mouth disease virus.

Article 5

Article 7

Temporary control zone

Movements onto and off a holding in case of suspicion of
an outbreak of foot-and-mouth disease

1. Member States shall ensure that in addition to the
measures provided for in Article 4, all movement onto and off
a holding where there is a suspicion of an outbreak of foot-
and-mouth disease is prohibited. That prohibition shall apply
in particular to:

The competent authority may establish a temporary
1.
control zone, where required by the epidemiological-situation,
and in particular when that situation involves a high density
of animals of susceptible species,
intensive movement of
animals or persons in contact with animals of susceptible
species, delays in suspect status notifications, or insufficient
information on the possible origin and ways of introduction
of the foot-and-mouth disease virus.

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2.
At least the measures provided for in Article 4(2) and
(3)(a), (b) and (d) and in Article 5(1) shall be applied to holdings
in the temporary control zone where animals of susceptible
species are kept.

3.
The measures applied in the temporary control zone
may be supplemented by a temporary ban on movements of
all animals in a larger area or on the whole of the territory of
a Member State. However, the ban on movement of animals
of species not susceptible to foot-and-mouth disease shall not
exceed 72 hours, unless justified by exceptional circumstances.

Article 8

Preventive eradication programme

1.
The competent authority may, where epidemiological
information or other evidence indicates, implement a preven-
tive eradication programme, including preventive killing of
animals of susceptible species likely to be contaminated and, if
necessary, of animals from epidemiologically-linked pro-
duction units or adjoining holdings.

2.
In that event, the taking of samples and clinical examin-
ations of animals of susceptible species shall be carried out at
least in accordance with point 2.1.1.1 of Annex III.

3.
The competent authority shall notify the Commission
prior to the implementation of the measures provided for in
this Article.

Article 9

Maintenance of measures

Member States shall not withdraw the measures provided for
in Articles 4 to 7 until the suspicion of foot-and-mouth disease
has been officially ruled out.

SECTION 3

MEASURES IN CASE OF CONFIRMATION

Article 10

Measures in case of confirmation of an outbreak of foot-
and-mouth disease

1.
As soon as an outbreak of foot-and-mouth disease is
confirmed, Member States shall ensure that, in addition to the
measures provided for in Articles 4 to 6 the following measures
are also applied without delay on the holding:

(a) All animals of susceptible species shall be killed on-the-

spot.

In exceptional circumstances the animals of susceptible
species may be killed at the nearest suitable place for that
purpose under official supervision and in such a way as
to avoid the risk of spreading foot-and-mouth disease
virus during transport and killing. The Member State
concerned shall notify the Commission about the exist-
ence of such exceptional circumstances, and the action
taken.

(b) The official veterinarian shall ensure that before or during
the killing of the animals of susceptible species all
appropriate samples needed for the epidemiological
inquiry referred to in Article 13 have been taken in
accordance with point 2.1.1.1 of Annex III, and in
sufficient numbers.

The competent authority may decide that Article 4(2)
shall not apply in cases of appearance of a secondary
source which is epidemiologically linked with a primary
source for which samples have already been taken in
accordance to that Article, provided that appropriate and
sufficient numbers of samples needed for the epidemiolo-
gical inquiry referred to in Article 13 have been taken.

(c) The carcasses of animals of susceptible species which
have died on the holding and the carcasses of animals
which have been killed in accordance with point (a)
shall be processed without undue delay under official
supervision in such a way that there is no risk of
spreading foot-and-mouth disease virus. Where particular
circumstances require the carcasses to be buried or
burned, on site or off site, such operations shall be carried
out
in conformity with the instructions prepared in
advance in the framework of the contingency plans
referred to in Article 72.

(d) All products and substances referred to in Article 4(3)(c)
shall be isolated until contamination can be ruled out, or
treated in accordance with the instructions of the official
veterinarian in such a way as to ensure the destruction of
any foot-and-mouth disease virus, or processed.

After the killing and processing of

the animals of
2.
susceptible species and the completion of
the measures
provided for in paragraph 1(d), Member States shall ensure
that:

(a)

(b)

the buildings used for housing animals of susceptible
species, their surroundings and the vehicles used for
their transportation, as well as all other buildings and
equipment likely to be contaminated shall be cleaned and
disinfected in accordance with Article 11;

in addition, where there is a reasonable suspicion that the
living area for humans or the office area of the holding
are contaminated with the foot-and-mouth disease virus,
these areas shall also be disinfected by appropriate means;

(c)

restocking of animals is carried out in accordance with
Annex V.

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Article 11

Cleansing and disinfection

1. Member States shall ensure that cleansing and disin-
fection operations, as integral parts of the measures provided
for in this Directive, are adequately documented and are carried
out under official supervision and in accordance with the
instructions given by the official veterinarian, using disinfec-
tants and working concentrations of
such disinfectants
officially authorised and registered for placing on the market
by the competent authority as veterinary hygiene biocidal
products in accordance with Directive 98/8/EC, in order to
ensure destruction of the foot-and-mouth disease virus.

2. Member States shall ensure that cleansing and disin-
fection operations, which shall include appropriate pest con-
trol, are carried out in a way to reduce as much as possible any
that may arise from such
adverse environmental
operations.

impact

3. Member States shall endeavour to ensure that any
in addition to being able to disinfect
disinfectants used,
effectively, also have the lowest possible adverse impacts on
the environment and public health in accordance with best
available technology.

questionnaires, prepared within the framework of the contin-
gency plans provided for in Article 72, to ensure standardised,
speedy and targeted inquiries. Such inquiries shall deal at least
with:

(a)

(b)

(c)

(d)

the length of time during which the foot-and-mouth
disease may have been present on a holding before being
suspected or notified;

the possible origin of the foot-and-mouth disease virus
on a holding and the identification of other holdings
where there are animals suspected of being infected or
animals suspected of being contaminated from the same
source;

to which animals of susceptible
the possible extent
species other than bovine and porcine animals may have
been infected or contaminated;

the movement of animals, persons, vehicles and the
substances referred to in Article 4(3)(c) likely to have
carried the foot-and-mouth disease virus to or from the
holdings in question.

2. Member States shall inform and regularly update the
Commission and the other Member States about the epidemi-
ology and spread of the foot-and-mouth disease virus.

4. Member States shall ensure that cleansing and disin-
fection operations are carried out in accordance with Annex IV.

Article 14

Article 12

Additional measures in case of confirmation of outbreaks
of foot-and-mouth disease

Tracing and treatment of products and substances derived
from or having been in contact with animals of an
outbreak of foot-and-mouth disease

Member States shall ensure that the products and substances
referred to in Article 4(3)(c) of animals of susceptible species
collected from a holding where an outbreak of
foot-and-
mouth disease has been confirmed and semen, ova and
embryos collected from animals of susceptible species present
on that holding, during the period between the probable
introduction of the disease to the holding and the implemen-
tation of official measures, shall be traced and processed or, in
the case of substances other than semen, ova and embryos, be
treated under official supervision and in such a way as to
ensure destruction of foot-and-mouth disease virus and to
avoid any risk of it spreading further.

Article 13

Epidemiological inquiry

1. Member States shall ensure that epidemiological inquiries
in relation to outbreaks of foot-and-mouth disease are carried
out by specifically trained veterinarians on the basis of

The competent authority may order that, besides the
1.
animals of susceptible species, animals of species not suscep-
tible to foot-and-mouth disease on the holding where an
outbreak of foot-and-mouth disease has been confirmed shall
also be killed and processed of in such a way as to avoid any
risk of spreading the foot-and-mouth disease virus.

However, the first subparagraph shall not apply to animals of
species not susceptible to foot-and-mouth disease which may
be isolated, effectively cleansed and disinfected, and provided
that they are individually identified, in the case of equidae in
accordance with Community legislation, so as to allow the
control of their movement.

2.
The competent authority may apply the measures pro-
vided for in Article 10(1)(a) on epidemiologically-linked pro-
duction units or adjoining holdings, where epidemiological
information or other evidence give reason to suspect a possible
contamination of those holdings. The intention to make use
of those provisions shall be notified to the Commission, where
possible, prior to implementation. In this event, the measures
regarding taking of samples and clinical examinations of
animals shall be carried out at least as set out in point 2.1.1.1
of Annex III.

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3.
The competent authority shall, immediately upon confir-
mation of the first outbreak of foot-and-mouth disease prepare
all arrangements necessary for emergency vaccination in an
area of at least the size of the surveillance zone established in
accordance with Article 21.

The competent authority may apply the measures pro-

4.
vided for in Articles 7 and 8.

SECTION 4

MEASURES TO BE APPLIED IN SPECIAL CASES

Article 15

Measures to be applied in case of an outbreak of foot-and-
mouth disease in the vicinity or within certain specific
premises keeping on a temporary or regular basis animals
of susceptible species

1. Where an outbreak of foot-and-mouth disease threatens
to infect animals of susceptible species in a laboratory, zoo,
wildlife park, and fenced area or in bodies, institutes or centres
approved in accordance with Article 13(2) of Directive 92/65/
EEC and where animals are kept for scientific purposes or
purposes related to conservation of species or farm animal
genetic resources, the Member State concerned shall ensure
that all appropriate bio-security measures are taken to protect
such animals from infection. Those measures may include
restricting access to public institutions or making such access
subject to special conditions.

2. Where an outbreak of foot-and-mouth disease is con-
firmed in one of the premises referred to in paragraph 1,
the Member State concerned may decide to derogate from
Article 10(1)(a), provided that basic Community interests, and
in particular the animal health status of other Member States,
are not endangered and that all necessary measures are in place
to prevent any risk of spreading foot-and-mouth disease virus.

Article 16

Measures to be applied in slaughterhouses, border inspec-
tion posts and means of transportation

1. Where a case of foot-and-mouth disease is confirmed in
a slaughterhouse, a border inspection post established in
accordance with Directive 91/496/EEC or in a means of
transport, the competent authority shall ensure that the
following measures are carried out in relation to the affected
premises or means of transport:

(a)

(b)

(c)

all animals of susceptible species in such premises or
means of transport shall be killed without delay;

the carcasses of the animals referred to in paragraph (a)
shall be processed under official supervision in such a
way as to avoid the risk of foot-and-mouth disease virus
spreading;

other animal waste, including offal, of infected or suspect-
ed of being infected and contaminated animals shall be
processed under official supervision in such a way as to
avoid the risk of foot-and-mouth disease virus spreading;

(d) dung, manure and slurry shall be subject to disinfection
and shall only be removed for treatment in accordance
with point 5 of Section II in Part A of Chapter III of
Annex VIII to Regulation (EC) No 1774/2002;

(e)

cleansing and disinfection of buildings and equipment,
including vehicles or means of transport, shall take place
under the supervision of the official veterinarian in
accordance with Article 11 and with the instructions laid
down by the competent authority;

(f)

an epidemiological inquiry shall be carried out in accord-
ance with Article 13.

2. Member States shall ensure that the measures provided
for in Article 19 are applied in contact holdings.

3. Member States shall ensure that no animals are reintro-
duced for slaughter, inspection or transport in the premises or
means of transport referred to in paragraph 1 until at least
24 hours after completion of the cleansing and disinfection
operations referred to in paragraph 1(e).

3.
The decision referred to in paragraph 2 shall immediately
be notified to the Commission. In the case of farm animal
genetic resources, this notification shall include a reference to
the
established in accordance with
Article 77(2)(f), by which the competent authority has ident-
ified these premises in advance as breeding nucleus of animals
of susceptible species indispensable for the survival of a breed.

list of premises

in
4. Where required by the epidemiological situation,
particular where contamination of animals of susceptible
species in holdings adjacent to the premises ore means of
transport referred to in paragraph 1 must be suspected,
Member States shall ensure that by way of derogation from
Article 2(b), second sentence, an outbreak is declared on the
premises or means of transport referred to in paragraph 1, and
the measures provided for in Articles 10 and 21 are applied.

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Article 17

Review of measures

The Commission shall review the situation regarding the
special cases referred to in Article 15 in the Standing Com-
mittee on the Food Chain and Animal Health at the earliest
possible opportunity. The necessary measures to prevent the
spread of the foot-and-mouth disease virus, in particular in
relation to regionalisation in accordance with Article 45, and
to emergency vaccination in accordance with Article 52, shall
be adopted in accordance with the procedure referred to in
Article 89(3).

SECTION 5

HOLDINGS CONSISTING OF DIFFERENT EPIDEMIOLOGICAL
PRODUCTION UNITS AND CONTACT HOLDINGS

Article 18

Holdings consisting of different epidemiological pro-
duction units

1.
In the case of holdings which consist of two or more
separate production units, the competent authority may, in
exceptional cases and after considering the risks, derogate
from Article 10(1)(a) as regards production units of such
holdings not affected by foot-and-mouth disease.

2.
The derogation provided for in paragraph 1 shall only
be granted after the official veterinarian has confirmed at the
time of the official investigation referred to in Article 4(2), that
the following conditions to prevent the spread of foot-and-
mouth disease virus between the production units referred to
in paragraph 1, have been in place for at least two incubation
periods prior to the date the outbreak of foot-and-mouth
disease was identified on the holding:

(a)

(b)

(c)

the structure, including the administration, and size of
the premises allow a complete separation of housing and
keeping for the distinct herds of animals of susceptible
species, including separate air space;

the operations on the different production units, and
in particular stable and pasture management, feeding,
removal of dung or manure are completely separated and
carried out by different personnel;

the machinery, working animals of species not susceptible
installations,
to foot-and-mouth disease, equipment,
instruments and disinfection facilities used in the pro-
duction units are completely separate.

In relation to milk, a derogation from Article 10(1)(d)

3.
may be granted to a holding producing milk provided that:

(a)

such holding complies with the conditions set out in
paragraph 2, and

(b) milking in each unit is carried out separately, and

(c)

depending on the intended use, the milk is subject to at
least one of the treatments described in Part A or Part B
of Annex IX.

4. Where a derogation is granted in accordance with
paragraph 1, Member States shall lay down in advance detailed
rules for applying such derogation. The Member States shall
notify the Commission of the derogation and provide details
of the measures taken.

Article 19

Contact holdings

1.
Holdings shall be recognised as contact holdings where
the official veterinarian finds, or considers on the basis of
confirmed data, that the foot-and-mouth disease virus may
have been introduced as a result of the movement of persons,
animals, products of animal origin, vehicles or in any other
way either from other holdings onto a holding referred to in
Articles 4(1) or 10(1) or from a holding referred to in
Articles 4(1) or 10(1) to other holdings.

Contact holdings shall be subject

2.
to the measures
provided for in Articles 4(3) and 5 and these measures shall be
maintained until the suspected presence of foot-and-mouth
disease virus on these contact holdings has been officially ruled
out in accordance with the definition in Annex I and the
survey requirements provided for in point 2.1.1.1 of Annex III.

3.
The competent authority shall prohibit the removal of
all animals from contact holdings during a period correspond-
ing to the incubation period specified for the species concerned
in Article 2(h). However, the competent authority may, by way
of derogation from Article 4(3)(d), authorise the transport of
animals of susceptible species under official supervision
directly to the closest possible designated slaughterhouse for
emergency slaughter.

Prior to granting such derogation, the official veterinarian shall
at least carry out the clinical examinations provided for in
point 1 of Annex III.

4. Where the competent authority considers that the epide-
miological situation permits, it may limit the recognition as a
contact holding provided for in paragraph 1, to one identified
epidemiological production unit of the holding and to the
animals contained therein, provided that the epidemiological
production unit complies with Article 18.

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5. Where an epidemiological link between an outbreak of
foot-and-mouth disease and premises or means of transpor-
tation referred to in Articles 15 and 16 respectively cannot be
excluded, Member States shall ensure that
the measures
provided for in Article 4(2) and (3) and in Article 5 shall apply
to such premises or means of transportation. The competent
authority may decide to apply the measures provided for in
Article 8.

5. Member States shall without delay trace animals dispat-
ched from the zones during the period of at least 21 days
before the estimated date of earliest infection on a holding in
the protection zone and they shall
inform the competent
authorities in other Member States and the Commission about
their results from tracing of animals.

Article 20

Coordination of measures

The Commission may review the situation regarding the
holdings referred to in Articles 18 and 19 in the Standing
Committee on the Food Chain and Animal Health with a view
to the adoption, in accordance with the procedure referred to
in Article 89(3), of the necessary measures to ensure coordi-
nation of the measures implemented by the Member States
pursuant to Articles 18 and 19.

6. Member States shall collaborate in tracing fresh meat,
meat products, raw milk and raw milk products derived from
animals of susceptible species originating in the protection
zone and produced between the date of estimated introduction
of the foot-and-mouth disease virus until the date the measures
provided for in paragraph 2 come into force. Such fresh meat,
meat products, raw milk and raw milk products shall be
treated in accordance with Articles 25, 26 and 27 respectively
or detained until possible contamination with the foot-and-
mouth disease virus is officially ruled out.

Article 22

SECTION 6

PROTECTION AND SURVEILLANCE ZONES

Measures to be applied to holdings in the protection zone

Article 21

1. Member States shall ensure that at least the following
measures are applied in the protection zone without delay:

Establishment of protection and surveillance zones

1. Member States shall ensure that, without prejudice to
measures provided for in Article 7, at least the measures laid
down in paragraphs 2, 3 and 4 below are taken immediately
after an outbreak of foot-and-mouth disease is confirmed.

2.
The competent authority shall establish a protection
zone based on a minimum radius of 3 km and a surveillance
zone based on a minimum radius of 10 km centred on the
outbreak of foot-and-mouth disease referred to in paragraph 1.
The geographical delimitation of those zones shall take account
of administrative boundaries, natural barriers, supervision
facilities and technological progress which makes it possible
to predict the probable dispersion of the foot-and-mouth
disease virus by air or any other means. That delimitation shall
be reviewed, if necessary, in the light of such elements.

The competent authority shall ensure that the protection
3.
and surveillance zones are marked by posting signs of sufficient
size on roads entering the zones.

(a)

(b)

the registration of all holdings with animals of susceptible
species and the establishment of a census of all animals
present on these holdings shall be carried out as soon as
possible and kept up to date;

all holdings with animals of susceptible species shall
periodically undergo a veterinary inspection, carried out
in such a way as to avoid the spread of foot-and-mouth
disease virus possibly present on the holdings, which
shall include in particular the relevant documentation,
notably the records referred to in subparagraph (a) and
the measures applied to prevent the introduction or
escape of foot-and-mouth disease virus and which may
include clinical inspection as described in point 1 of
Annex III or taking of samples from animals of susceptible
species in accordance with point 2.1.1.1 of Annex III;

(c)

animals of susceptible species shall not be removed from
the holding on which they are kept.

4.
In order to ensure full coordination of all measures
necessary to eradicate foot-and-mouth disease as quickly as
possible, national and local disease control centres as referred
to in Articles 74 and 76 shall be established. For the purpose
of carrying out the epidemiological inquiry as provided for in
Article 13, those centres shall be assisted by an expert group
as provided for in Article 78.

By way of derogation from paragraph 1(c), animals
2.
of susceptible species may be transported under official
supervision for the purpose of emergency slaughter directly to
a slaughterhouse situated inside the same protection zone or,
if that zone has no slaughterhouse to a slaughterhouse outside
the zone designated by the competent authority in means of
transport cleansed and disinfected under official control after
each transport operation.

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The movement referred to in the first subparagraph shall only
be authorised if the competent authority is satisfied on the
basis of a clinical examination in accordance with point 1 of
Annex III by the official veterinarian of all the animals of
susceptible species present on the holding and after evaluation
of epidemiological circumstances that there is no reason to
suspect the presence of infected or contaminated animals on
the holding. The meat of such animals shall be subject to the
measures provided for in Article 25.

Article 23

Movement and transport of animals and their products in
the protection zone

Member States shall ensure that the following activities are
prohibited within the protection zone:

(a) movement between holdings and transport of animals of

susceptible species;

(b)

(c)

(d)

fairs, markets, shows and other gatherings of animals
including collection and dispersion of susceptible species;

itinerant service for breeding of animals of susceptible
species;

artificial
embryos from animals of susceptible species.

insemination of and collection of ova and

Article 24

(g)

transport of goods referred to in Article 33 to holdings
keeping animals of susceptible species.

2.

The competent authorities may authorise:

(a)

(b)

(c)

(d)

(e)

the transit of animals of all species through the protection
zone undertaken exclusively via major highways or
mainline railways;

the transport of animals of susceptible species which
have been certified by the official veterinarian as coming
from holdings outside the protection zone and transport-
ed on designated routes directly to designated slaughter-
houses for immediate slaughter, provided that the means
of transport are cleansed and disinfected after delivery
under official supervision at the slaughterhouse and such
decontamination of transport is recorded in the logbook
of the means of transport;

the artificial insemination of animals on a holding carried
out by the personnel of that holding by use of semen
collected from animals on that holding or semen stored
on that holding or semen delivered from a semen
collection centre to the outside perimeter of that holding;

the movement and transport of equidae taking into
account the conditions set out in Annex VI.

the transport, under certain conditions, of goods referred
to in Article 33 to holdings keeping animals of susceptible
species.

Additional measures and derogations

Article 25

The competent authority may extend the prohibitions in

1.
Article 23 to:

Measures in relation to fresh meat produced in the
protection zone

(a) movement or transport of animals of non-susceptible
species between holdings situated within the zone or out
of or into the protection zone;

(b)

(c)

(d)

transit of animals of all species through the protection
zone;

events with gatherings of people with possible contact
with animals of susceptible species, where there is a risk
of spreading the foot-and-mouth disease virus;

artificial insemination of or collection of ova and embryos
from animals of species not susceptible to foot-and-
mouth disease;

(e) movement of means of
transportation of animals;

transport designed for the

(f)

the slaughter on the holding of animals of susceptible
species for private consumption;

1. Member States shall ensure that the placing on the
market of fresh meat, minced meat and meat preparations,
derived from animals of susceptible species originating in the
protection zone shall be prohibited.

2. Member States shall ensure that the placing on the
market of fresh meat, minced meat and meat preparations
from animals of susceptible species produced in establishments
situated in the protection zone shall be prohibited.

3. Member States shall ensure that fresh meat, minced meat
and meat preparations as referred to in paragraph 1, shall
be marked in accordance with Directive 2002/99/EC and
subsequently transported in sealed containers to an establish-
ment designated by the competent authorities for transform-
ation into meat products treated in accordance with point 1 in
Part A of Annex VII of this Directive.

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4.
By way of derogation, the prohibition provided for in
paragraph 1 shall not apply to fresh meat, minced meat and
meat preparations which were produced on a date at least
21 days before the estimated date of earliest infection on a
holding in the protection zone and which since production
have been stored and transported separately from such meats
produced after that date. Such meats must be readily dis-
tinguished from meats not eligible for dispatch outside the
protection zone by means of clear mark established in
conformity with Community legislation.

5.
By way of derogation, the prohibition provided for in
paragraph 2, shall not apply to fresh meat, minced meat or
meat preparations obtained from establishments situated in
the protection zone under the following conditions:

(a)

the establishment shall be operated under strict veterinary
control;

(b) only fresh meat, minced meat or meat preparations as
described in paragraph 4, or fresh meat, minced meat or
meat preparations obtained from animals reared and
slaughtered outside the protection zone or from animals
transported to the establishment and slaughtered therein
in accordance with the provisions in Article 24(2)(b) shall
be processed in the establishment;

(c)

all such fresh meat, minced meat or meat preparations,
must bear the health mark in accordance with Chapter XI
of Annex I to Directive 64/433/EEC or in the case of
meat from other biungulates the health mark provided
for in Chapter III of Annex I to Directive 91/495/EEC, or
in the case of minced meat and meat preparations the
health mark as provided for in Chapter VI of Annex I to
Directive 94/65/EC;

(d) during the whole production process all such fresh meat,
minced meat or meat preparations must be clearly
identified, and transported and stored separately from
fresh meat, minced meat or meat preparations which are
not eligible for dispatch outside the protection zone in
accordance with this Directive.

Compliance with the conditions in paragraph 5 shall be
6.
certified by the competent authority for fresh meat, minced
meat and meat preparations intended for intra-Community
trade. The competent authority shall supervise the control of
compliance undertaken by the local veterinary authority and,
in the case of intra-Community trade, communicate to other
Member States and the Commission a list of those establish-
ments which it has approved for the purpose of such
certification.

7.
Derogation from the prohibition provided for in para-
graph 1 may be granted subject to specific conditions adopted
in accordance with the procedure referred to in Article 89(3),
in particular with regard to the health marking of meat
produced from animals of susceptible species originating in
protection zones maintained for more than 30 days.

Article 26

Measures in relation to meat products produced in the
protection zone

1. Member States shall ensure that the placing on the
market of meat products produced from meat derived from
animals of susceptible species originating in the protection
zone shall be prohibited.

2.
By way of derogation, the prohibition in paragraph 1
shall not apply to meat products which have either undergone
one of the treatments as set out in point 1 in Part A of
Annex VII or which have been produced from meats referred
to in Article 25(4).

Article 27

Measures in relation to milk and milk products produced
in the protection zone

1. Member States shall ensure that the placing on the
market of milk derived from animals of susceptible species
originating in the protection zone and of milk products
produced from such milk shall be prohibited.

2. Member States shall ensure that the placing on the
market of milk and milk products from animals of susceptible
species produced in an establishment situated in the protection
zone shall be prohibited.

3.
By way of derogation, the prohibition provided for in
paragraph 1 shall not apply to milk and milk products
derived from animals of susceptible species originating in the
protection zone which were produced on a date at least
21 days before the estimated date of earliest infection on a
holding in the protection zone and which since production
have been stored and transported separately from milk and
milk products produced after that date.

By way of derogation, the prohibition provided for in
4.
paragraph 1 shall not apply to milk derived from animals of
susceptible species originating in the protection zone and milk
products produced from such milk which have undergone one
of the treatments as set out in Parts A or B of Annex IX,
depending on the use of the milk or milk products. The
treatment shall be carried out under the conditions set out in
paragraph 6 in establishments referred to in paragraph 5 or, if
there is no establishment situated in the protection zone, in
establishments situated outside the protection zone under the
conditions set down in paragraph 8.

5.
By way of derogation, the prohibition provided for in
paragraph 2 shall not apply to milk and milk products which
have been prepared in establishments situated in the protection
zone under the conditions set out in paragraph 6.

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Establishments referred to in paragraphs 4 and 5 shall

6.
comply with the following conditions:

accordingly and may only be moved to another area after
cleansing and disinfection under official supervision.

(a)

(b)

(c)

(d)

the establishment shall be operated under permanent and
strict official control;

all milk used in the establishment shall either comply
with paragraphs 3 and 4 or the raw milk shall be obtained
from animals outside the protection zone;

during the whole production process the milk shall be
clearly identified and transported and stored separately
from raw milk and raw milk products which are not
destined for dispatch outside the protection zone;

transport of raw milk from holdings situated outside the
protection zone to the establishments shall be carried out
in vehicles which were cleaned and disinfected prior to the
transport operation, and which have had no subsequent
contact with holdings in the protection zone keeping
animals of susceptible species.

7.
Compliance with the conditions in paragraph 6 shall be
certified by the competent authority for milk intended for intra-
Community trade. The competent authority shall supervise the
control of compliance undertaken by the local veterinary
authority and, in the case of intra-Community trade, communi-
cate to other Member States and the Commission a list of
those establishments which it has approved for the purpose of
such certification.

8.
Transport of raw milk from holdings situated within
the protection zone to establishments situated outside the
protection zone and the processing of that milk shall be
subject to the following conditions:

(a) processing in establishments situated outside the protec-
tion zone of raw milk produced from animals of suscep-
tible species kept within the protection zone shall be
authorised by the competent authorities;

(b)

(c)

the authorisation shall include instructions on and desig-
nation of the transport route to the designated establish-
ment;

transport shall be carried out in vehicles which were
cleaned and disinfected prior to the transport operation,
which are constructed and maintained in such a way that
there is no leakage of milk during transport and which
are equipped to avoid aerosol dispersion during the
loading and unloading of the milk;

(d) before leaving the holding from where milk of animals of
susceptible species was collected the connection pipes,
tires, wheel cases, the lower parts of the vehicle and any
spillage of milk are cleansed and disinfected and after the
last disinfection and before leaving the protection zone
the vehicle had no subsequent contact with holdings
in the protection zone keeping animals of susceptible
species;

(e)

the means of transport are strictly assigned to a defined
geographical or administrative area, they are marked

9.
The collection and transport of samples of raw milk of
animals of susceptible species from holdings situated in the
protection zone to a laboratory other than a veterinary
foot-and-
diagnostic laboratory approved for diagnosis of
mouth disease and the processing of
the milk in such
laboratories shall be forbidden.

Article 28

Measures in relation to semen, ova and embryos collected
from animals of susceptible species in the protection zone

1. Member States shall ensure that the placing on the
market of semen, ova and embryos derived from animals of
susceptible species originating in the protection zone shall be
prohibited.

By way of derogation, the prohibition provided for in
2.
paragraph 1 shall not apply to frozen semen, ova and embryos
collected and stored at least 21 days before the estimated date
of earliest infection with the foot-and-mouth disease virus on
a holding in the zone.

3.
Frozen semen collected in accordance with Community
legislation after the date of infection referred to in paragraph 2,
shall be stored separately and shall only be released after:

(a)

(b)

(c)

all the measures relating to the outbreak of foot-and-
mouth disease have been removed in accordance with
Article 36, and

all animals accommodated in the semen collection centre
have undergone a clinical examination, and samples
taken in accordance with point 2.2 of Annex III have
been subjected to a serological test to substantiate the
absence of
infection in the semen collection centre
concerned, and

the donor animal has been subjected with negative result
to a serological test for the detection of antibodies against
the foot-and-mouth disease virus on a sample taken not
earlier than 28 days after the collection of the semen.

Article 29

Transport and distribution of dung and manure of animals
of susceptible species produced in the protection zone

1. Member States shall ensure that the transport and
distribution of dung or manure from holdings and premises
or means of transport referred to in Article 16 situated in the
protection zone where animals of susceptible species are kept,
shall be prohibited within the protection zone.

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2.
By way of derogation from the prohibition in para-
graph 1 the competent authority may authorise the removal
of manure of animals of susceptible species from a holding
situated in the protection zone to a designated plant for
treatment in accordance with point 5 of Section II in Part A of
Chapter III of Annex VIII to Regulation (EC) No 1774/2002 or
for intermediate storage.

3.
By way of derogation from the prohibition in para-
graph 1 the competent authority may authorise the removal
of manure of animals of susceptible species from holdings
situated in the protection zone which are not subject to the
measures provided for in Articles 4 or 10 for distribution on
designated fields under the following conditions:

(a)

the entire volume of manure has been produced at least
21 days before the estimated date of earliest infection on
a holding in the protection zone and the manure or dung
is distributed close to the ground and in sufficient distance
from holdings keeping animals of susceptible species and
immediately incorporated into the ground, or

(b)

in the case of manure from bovine animals or pigs:

(i)

(ii)

(iii)

an examination by an official veterinarian of all the
animals on the holding has ruled out the presence
of animals suspected of being infected with the foot-
and-mouth disease virus, and

the entire volume of manure has been produced at
least 4 days prior to the examination referred to in
point (i), and

the manure is incorporated into the ground on
designated fields close to the holding of origin and
in sufficient distance to other holdings keeping
animals of susceptible species in the protection
zone.

4. Member states shall ensure that any authorisation to
remove dung or manure from a holding keeping animals of
susceptible species is subject to stringent measures to avoid
spread of the foot-and-mouth disease virus, in particular by
ensuring cleansing and disinfection of the leak-proof transport
vehicles after loading and before leaving the holding.

Article 30

Measures in relation to hides and skins from animals of
susceptible species in the protection zone

1. Member States shall ensure that the placing on the
market of hides and skins of animals of susceptible species
originating in the protection zone shall be prohibited.

By way of derogation, the prohibition as provided for in

2.
paragraph 1 shall not apply to hides and skins which either:

(a) were produced at least 21 days before the estimated date
of infection on the holding referred to in Article 10(1),
and that have been stored separately from hides and skins
produced after that date; or

(b)

comply with the requirements laid down in point 2 in
Part A of Annex VII.

Article 31

Measures in relation to sheep wool, ruminant hair and pig
bristles produced in the protection zone

1. Member States shall ensure that the placing on the
market of sheep wool, ruminant hair and pig bristles originat-
ing in the protection zone shall be prohibited.

2.
By way of derogation, the prohibition as provided for in
paragraph 1 shall not apply to unprocessed wool, hair and
bristles which:

(a) were produced at least 21 days before the estimated date
of infection on the holding referred to in Article 10(1)
and have been stored separately from wool, hair and
bristles produced after that date; or

(b)

comply with the requirements laid down in point 3 in
Part A of Annex VII.

Article 32

Measures in relation to other animal products produced
in the protection zone

1. Member States shall ensure that the placing on the
market of animal products derived from animals of susceptible
species not referred to in Articles 25 to 31 shall be prohibited.

2.
By way of derogation, the prohibitions provided for in
paragraph 1 shall not apply to products referred to in
paragraph 1 which:

(a)

either have been produced at least 21 days before the
estimated date of infection on the holding referred to in
Article 10(1) and have been stored and transported
separately from products produced after that date, or

(b) have undergone the treatment in accordance with point 4

in Part A of Annex VII, or

(c)

(d)

for specific products, comply with the appropriate
requirements in points 5 to 9 in Part A of Annex VII, or

are composite products which are not subject to further
treatment containing products of animal origin which
either have undergone a treatment ensuring destruction
of possible foot-and-mouth disease virus or have been
obtained from animals not subject to restrictions under
the provisions of this Directive, or

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(e)

are packed products intended for use as in-vitro diagnostic
or laboratory reagents.

3.
Detailed rules for the implementation of the measures
provided for in paragraph 2 may be adopted in accordance
with the procedure referred to in Article 89(2).

Article 33

Article 35

Measures in relation to feed, forage, hay and straw
produced in the protection zone

Additional measures applied by Member States in the
protection zone

1. Member State shall ensure that the placing on the market
of feed, forage, hay and straw originating in the protection
zone shall be prohibited.

By way of derogation, the prohibition provided for in

2.
paragraph 1 shall not apply to feed, forage, hay and straw:

(a) produced at least 21 days before the estimated date of
infection on holdings referred to in Article 10(1), and
stored and transported separately from feed, forage, hay
and straw produced after that date; or

(b)

intended for use within the protection zone, subject to
authorisation by the competent authorities; or

(c) produced on premises not keeping animals of susceptible

species; or

(d) produced in establishments not keeping animals of
susceptible species and sourcing the raw material from
premises referred to in paragraph (c) or from premises
situated outside the protection zone.

3.
By way of derogation, the prohibition provided for in
paragraph 1 shall not apply to forage and straw produced on
holdings keeping animals of susceptible species which comply
with the requirements in point 1 in Part B of Annex VII.

Article 34

Granting of derogations and additional certification

1.
Any derogation from the prohibitions provided for in
Articles 24 to 33 shall be granted by a specific decision of the
competent authority only after it has satisfied itself that all
relevant requirements have been met for a sufficient period
before the products leave the protection zone, and that there
is no risk of spreading the foot-and-mouth disease virus.

In addition to the measures applicable in the protection zone
in accordance with this Directive, Member States may take
additional national measures which are deemed necessary and
proportionate to contain the foot-and-mouth disease virus
taking into account the particular epidemiological, animal
husbandry, commercial and social conditions prevailing in the
affected area. Member States shall inform the Commission and
the other Member States about such additional measures.

Article 36

Removal of measures in the protection zone

1. Member States shall ensure that the measures applied
in the protection zone are maintained until the following
requirements have been met:

(a)

at least 15 days have elapsed since the killing and safe
disposal of all the animals of susceptible species from the
holding referred to in Article 10(1) and the completion
of the preliminary cleansing and disinfection on that
holding, carried out in accordance with Article 11;

(b)

a survey has been concluded with negative results in all
holdings keeping animals of susceptible species and
situated within the protection zone.

After the removal of

2.
the measures specific to the
protection zone, the measures applied in the surveillance zone
as provided for in Articles 37 to 42, shall continue to apply
for at least 15 days until those measures are removed in
accordance with Article 44.

3.
The survey referred to in paragraph 1(b) shall be carried
out to substantiate the absence of infection and at least in
compliance with the criteria of point 1 of Annex III and shall
include the measures provided for in point 2.3 of Annex III
based on the criteria set out in points 2.1.1. and 2.1.3. of
Annex III.

Article 37

Measures to be applied to holdings in the surveillance
zone

Any derogation from the prohibitions provided for in
2.
Articles 25 to 33 requires, in the case of intra-Community
trade, additional certification by the competent authority.

1. Member States shall ensure that the measures provided
for in Article 22(1) are applied in the surveillance zone.

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2.
By way of derogation from the prohibition provided for
in Article 22(1)(c) and where there is no or insufficient
slaughter capacity available within the surveillance zone,
the competent authorities may authorise the removal from
holdings situated in the surveillance zone of animals of
susceptible species for transporting them directly and under
official supervision for slaughter to a slaughterhouse located
outside the surveillance zone, subject to the following con-
ditions:

(a)

(b)

(c)

the records referred to in Article 22(1) have been
subjected to official control, and the epidemiological
situation of the holding does not indicate any suspicion
of infection or contamination with the foot-and-mouth
disease virus, and

all the animals of susceptible species on the holding have
been subjected with negative result to an inspection by
the official veterinarian, and

a representative number of animals, taking into account
the statistical parameters in point 2.2 of Annex III, has
been subjected to thorough clinical examination to rule
out
the presence or suspicion of clinically infected
animals, and

(d)

the slaughterhouse is designated by the competent auth-
ority and located as near to the surveillance zone as
possible, and

(e)

the meat produced from such animals shall be subject to
the treatment specified in Article 39.

Article 38

Movement of animals of susceptible species within the
surveillance zone

1. Member States shall ensure that animals of susceptible
species shall not be removed from holdings within the
surveillance zone.

2.
By way of derogation, the prohibition provided for in
paragraph 1 shall not apply to movement of animals for one
of the following purposes:

(a)

for leading them without coming into contact with
animals of susceptible species of different holdings to
pasture situated within the surveillance zone not earlier
than 15 days after the last outbreak of foot-and-mouth
disease has been recorded in the protection zone;

(b)

for transporting them directly and under official super-
vision for the purpose of slaughter to a slaughterhouse
located inside the same zone;

(c)

for transporting them in accordance with Article 37(2);

(d)

for transporting them in accordance with Article 24(2)(a)
and (b).

3. Movements of animals provided for in paragraph 2(a)
shall be authorised by the competent authority only after an
examination by an official veterinarian of all the animals of
susceptible species on the holding, including testing of samples
taken in accordance with point 2.2 of Annex III, has ruled out
the presence of animals suspected of being infected or animals
suspected of being contaminated.

4. Movements of animals provided for in paragraph 2(b)
shall be authorised by the competent authority only after the
measures provided for in Article 37(2)(a) and (b) have been
completed with satisfactory results.

5. Member States shall without delay trace animals of
susceptible species dispatched from the surveillance zone
during a period of least 21 days before the estimated date of
earliest infection on a holding in the surveillance zone and
they shall inform the competent authorities in other Member
States about their results from tracing animals.

Article 39

Measures to be applied to fresh meat of animals of
susceptible species originating in the surveillance zone
and meat products produced from such meat

1. Member States shall ensure that the placing on the
market of fresh meat, minced meat and meat preparations
derived from animals of susceptible species originating in the
surveillance zone and of meat products produced from such
meats shall be prohibited.

2. Member States shall ensure that the placing on the
market of fresh meat, minced meat, meat preparations and
meat products from animals of susceptible species produced
in establishments situated in the surveillance zone shall be
prohibited.

3.
By way of derogation, the prohibition provided for in
paragraph 1 shall not apply to fresh meat, minced meat and
meat preparations which were produced on a date at least
21 days before the estimated date of earliest infection on a
holding in the corresponding protection zone and which since
production have been stored and transported separately from
such meats produced after that date. Such meats must be
readily distinguished from meats not eligible for dispatch
outside the surveillance zone by means of clear mark estab-
lished in conformity with Community legislation.

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4.
By way of derogation, the prohibition provided for in
paragraph 1 shall not apply to fresh meat, minced meat
and meat preparations which were produced from animals
transported to the slaughterhouse under conditions at least as
strict as provided for in Article 37(2)(a) to (e) under the
condition that the meat is subject to the measures provided
for in paragraph 5.

5.
By way of derogation, the prohibition provided for in
paragraph 2, shall not apply to fresh meat, minced meat or
meat preparations obtained from establishments situated in
the surveillance zone under the following conditions:

(a)

the establishment shall be operated under strict veterinary
control;

(b) only fresh meat, minced meat or meat preparations as
described in paragraph 4 and subject to the additional
conditions provided for in Part B of Annex VIII or
obtained from animals reared and slaughtered outside the
surveillance zone or obtained from animals transported
in accordance with the provisions in Article 24(2)(b) shall
be processed in the establishment;

(c)

all such fresh meat, minced meat or meat preparations
must bear the health mark in accordance with Chapter XI
of Annex I to Directive 64/433/EEC or in the case of
meat from other biungulates the health mark provided
for in Chapter III of Annex I to Directive 91/495/EEC, or
in the case of minced meat and meat preparations the
health mark as provided for in Chapter VI of Annex I to
Directive 95/65/EC;

(d) during the whole production process all such fresh meat,
minced meat or meat preparations must be clearly
identified, and transported and stored separately from
fresh meat, minced meat or meat preparations which are
not eligible for dispatch outside the surveillance zone in
accordance with this Directive.

6.
By way of derogation, the prohibition provided for in
paragraph 1, shall not apply to meat products produced from
fresh meat obtained from animals of susceptible species
originating in the surveillance zone which was marked with
the health mark provided for Directive 2002/99/EC and
transported under official supervision to a designated establish-
ment for treatment in accordance with point 1 in Part A of
Annex VII.

8.
Compliance with the conditions in paragraphs 5 and 7
shall be certified by the competent authority for fresh meat,
intra-
minced meat and meat preparations intended for
Community trade. The competent authority shall supervise the
control of compliance undertaken by the local veterinary
authority and in the case of intra-Community trade communi-
cate to other Member States and the Commission a list of
those establishments which it has approved for the purpose of
such certification.

Derogation from the prohibition provided for in para-
9.
graph 1 may be granted subject to specific conditions adopted
in accordance with the procedure referred to in Article 89(3),
in particular with regard to the health marking of meat
produced from animals of susceptible species originating in
surveillance zone maintained for more than 30 days.

Article 40

Measures to be applied to milk and milk products of
animals of susceptible species produced in the surveil-
lance zone

1. Member States shall ensure that placing on the market
of milk derived from animals of susceptible species originating
in the surveillance zone and of milk products produced from
such milk shall be prohibited.

2. Member States shall ensure that the placing on the
market of milk and milk products from animals of susceptible
species produced in the surveillance zone shall be prohibited.

3.
By way of derogation, the prohibition provided for in
paragraph 1 shall not apply to milk and milk products
derived from animals of susceptible species originating in the
surveillance zone which were produced on a date at least
21 days before the estimated date of earliest infection on a
holding in the corresponding protection zone and which since
production have been stored and transported separately from
milk and milk products produced after that date.

By way of derogation, the prohibition provided for in
4.
paragraph 1 shall not apply to milk derived from animals of
susceptible species originating in the surveillance zone and
milk products produced from such milk which have undergone
one of the treatments as set out in Parts A or B of Annex IX
depending on the use of the milk or milk products. The
treatment shall be carried out under the condition set out in
paragraph 6 in establishments referred to in paragraph 5 or, if
there is no establishment situated in the surveillance zone, in
establishments designated by the competent authorities and
situated outside the protection and surveillance zones.

7.
By way of derogation, the prohibition provided for in
paragraph 2, shall not apply to meat products produced in
establishments situated in the surveillance zone and either
complying with the provisions in paragraph 6, or produced
from meat complying with paragraph 5.

5.
By way of derogation, the prohibition provided for in
paragraph 2 shall not apply to milk and milk products
which have been prepared in establishments situated in the
surveillance zone under the conditions set out in paragraph 6.

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Establishments referred to in paragraphs 4 and 5 shall

6.
comply with the following conditions:

(e)

(a)

(b)

(c)

(d)

the establishment shall be operated under strict veterinary
control;

all milk used in the establishment shall either comply
with paragraph 4 or be obtained from animals outside
the surveillance and protection zone;

throughout the production process the milk shall be
clearly identified and transported and stored separately
from milk and milk products which are not destined for
dispatch outside the surveillance zone;

transport of raw milk from holdings situated outside the
protection and surveillance zone to the establishments
shall be carried out in vehicles which were cleaned and
disinfected prior to the transport operation, and which
have had no subsequent contact with holdings in the
protection and surveillance zones keeping animals of
susceptible species.

Compliance with the conditions in paragraph 6 shall be
7.
certified by the competent authority for milk intended for intra-
Community trade. The competent authority shall supervise the
control of compliance undertaken by the local veterinary
authority and, in the case of intra-Community trade, communi-
cate to other Member States and the Commission a list of
those establishments which it has approved for the purpose of
such certification.

8.
Transport of raw milk from holdings situated within
the surveillance zone to establishments situated outside the
protection and surveillance zones and the processing of that
milk shall be subject to the following conditions:

(a) processing in establishments situated outside the protec-
tion and surveillance zones of raw milk produced from
animals of susceptible species kept within the surveillance
zone shall be authorised by the competent authorities;

(b)

(c)

the authorisation shall include instructions on and desig-
nation of the transport route to the designated establish-
ment;

transport shall be carried out in vehicles which were
cleaned and disinfected prior to the transport operation,
which are constructed and maintained in such a way that
there is no leakage of milk during transport and which
are equipped to avoid aerosol dispersion during the
loading and unloading of the milk;

(d) before leaving the holding from where milk of animals of
susceptible species was collected, the connection pipes,
tires, wheel cases, the lower parts of the vehicle and any
spillage of milk are cleansed and disinfected and after the
last disinfection and before leaving the surveillance zone
the vehicle had no subsequent contact with holdings in
the protection and surveillance zones keeping animals of
susceptible species;

the means of transport are strictly assigned to a defined
geographical or administrative area, they are marked
accordingly and may only be moved to another area after
cleansing and disinfection under official supervision.

9.
The collection and transport of samples of raw milk of
animals of susceptible species from holdings situated in the
surveillance zone to a laboratory other than a veterinary
diagnostic laboratory approved for diagnosis of
foot-and-
mouth disease and the processing of
the milk in such
laboratories shall be subject to official authorisation and
measures to avoid any spread of possible foot-and-mouth
disease virus.

Article 41

Transport and distribution of dung and manure of animals
of susceptible species produced in the surveillance zone

1. Member States shall ensure that the transport and
distribution of dung or manure from holdings and other
premises such as those mentioned in Article 16 situated in the
surveillance zone where animals of susceptible species are kept
shall be prohibited within and outside that zone.

By way of derogation from the prohibition provided for
2.
in paragraph 1 the competent authorities may in exceptional
circumstances authorise the transport of dung or manure in
means of transport thoroughly cleansed and disinfected prior
to and after use for distribution in designated areas within the
surveillance zone and at sufficient distance to holdings where
animals of susceptible species are kept under the following
alternative conditions:

(a)

either an examination by an official veterinarian of all the
animals of susceptible species on the holding has ruled
out the presence of animals suspected of being infected
with the foot-and-mouth disease virus and the manure or
dung is distributed close to the ground to avoid the
generation of aerosols and immediately ploughed into
the ground, or

(b)

a clinical inspection by an official veterinarian of all the
animals of susceptible species on the holding has been
carried out with negative result and the manure is injected
into ground, or;

(c) manure is subject to the provision of Article 29(2).

Article 42

Measures in relation to other animal products produced
in the surveillance zone

Member State shall ensure that the placing on the market of
products of animal origin other than those referred to in
Articles 39 to 41 shall be subject to the conditions provided
for in Articles 28 and 30 to 32.

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Article 43

Additional measures applied by Member States in the
surveillance zone

In addition to the measures provided for in Articles 37 to 42,
Member States may take additional national measures which
are deemed necessary and proportionate to contain foot-
and-mouth disease virus taking into account the particular
epidemiological, animal husbandry, commercial and social
conditions prevailing in the affected area. Where specific
measures to restrict the movement of equidae are considered
necessary, such measures shall take into account those pro-
vided for in Annex VI.

2. Member States shall notify to the Commission without
delay the details of the measures implemented in the restricted
zone and the Commission shall review, where necessary
amend, and endorse the measures in accordance with the
procedure referred to in Article 89(3).

3. Without prejudice to the obligation of Member States to
regionalise referred to in paragraph 1, regionalisation, and the
measures to be applied within the restricted zone, may be
decided in accordance with the procedure referred to in
Article 89(3). This decision may extent its effects to neighbour-
ing Member States not infected at the time the measures are
taken.

Article 44

Removal of measures in the surveillance zone

1. Member states shall ensure that the measures applied in
the surveillance zone are maintained until
the following
requirements have been met:

(a)

at least 30 days have elapsed since the killing and safe
disposal of all animals of susceptible species from the
holding referred to in Article 10(1) and the completion
of the preliminary cleansing and disinfection on that
holding, carried out in accordance with Article 11;

(b)

the requirements provided for in Article 36 have been
met in the protection zone;

(c)

a survey has been concluded with negative results.

The survey referred to in paragraph 1(c) shall be carried
2.
out to substantiate the absence of infection in the surveillance
zone in compliance with the criteria of point 1 of Annex III
and shall include the measures provided for in point 2.4 of
Annex III based on the criteria of point 2.1 of Annex III.

SECTION 7

REGIONALISATION, MOVEMENT CONTROL AND IDENTIFI-
CATION

Article 45

Regionalisation

1. Without prejudice to Directive 90/425/EC, and in par-
ticular Article 10 thereof, where the foot-and-mouth disease
virus appears to be spreading despite the measures taken in
accordance with this Directive and the epizootic becomes
extensive and in any case when emergency vaccination is
implemented, Member States shall ensure that their territory is
regionalised into one or more restricted and free zones.

Prior to the delimitation of

4.
the restricted zone, a
thorough epidemiological assessment of the situation shall be
carried out, especially with respect to the possible time and
probable location of introduction, the possible spread and the
probable period of time necessary to eradicate the foot-and-
mouth disease virus.

The restricted zone shall as far as possible be delimited
5.
on the basis of administrative boundaries or geographical
barriers. Regionalisation shall take as its starting point larger
administrative units rather than regions. The restricted zone
may be reduced in the light of the results of the epidemiological
inquiry provided for in Article 13, to an area of the size not
less than a sub-region, and where necessary the surrounding
sub-regions. In the event of the foot-and-mouth disease virus
spreading, the restricted zone shall be enlarged by including
additional regions or sub-regions.

Article 46

Measures applied in a restricted zone of a member state

1. Where regionalisation is applied, Member States shall
ensure that at least the following measures are taken:

(a)

(b)

(c)

transport and
control within the restricted zone of
movement of animals of susceptible species, animal
products and goods and of the movement of means of
transport as potential carriers of foot-and-mouth disease
virus;

tracing and marking in accordance with Community
legislation of fresh meat and raw milk and as far as
possible other products in stock not eligible for dispatch
outside the restricted zone;

specific certification of animals of susceptible species and
products derived from such animals and health marking,
in accordance with Community legislation, of products
for human consumption intended and eligible for dis-
patch outside the restricted zone.

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2. Where regionalisation is applied, Member States shall
ensure that at least the animals of susceptible species dispat-
ched from the restricted zone to other Member States during
the time between the date of estimated introduction of the
foot-and-mouth disease virus until the date regionalisation is
implemented shall be traced, and such animals shall be isolated
under official veterinary control until possible infection or
contamination is officially ruled out.

3. Member States shall collaborate in tracing fresh meat
and raw milk and raw milk products derived from animals of
susceptible species produced in the restricted zone between
the date of estimated introduction of the foot-and-mouth
disease virus until the date regionalisation is implemented.
Such fresh meat shall be treated in accordance with point 1 in
Part A of Annex VII, and raw milk and milk products shall be
treated in accordance with Part A or B of Annex IX depending
on the use, or detained until possible contamination with the
foot-and-mouth disease virus is officially ruled out.

Specific measures,

4.
in particular in relation to health
marking of products derived from animals of susceptible
species originating in the restricted zone and not intended for
placing on the market outside the restricted zone may be
adopted in accordance with Article 4(3) of Directive 2002/99/
EC.

Article 47

Identification of animals of susceptible species

1. Without prejudice to Community legislation on identifi-
cation of domestic bovine, ovine and caprine animals and
swine, Member States shall ensure that in the event of an
outbreak of foot-and-mouth disease on their territory animals
of susceptible species shall only leave the holding on which
they are kept, if they are identified in such a way as to enable
the competent authorities to trace rapidly their movements
and their holding of origin, or any holding from which
they have come. However, for special cases referred to in
Article 15(1) and Article 16(1), the competent authority may,
in certain circumstances and having regard to the health
situation, authorise other ways of rapidly tracing the move-
ment of those animals and of their holding of origin, or of any
holding from which they have come. The arrangements for
identifying such animals or for tracing their holdings of origin
shall be determined by the competent authority and notified
to the Commission.

2.
The measures taken by Member States on additional,
permanent and indelible marking of animals for the particular
purpose of control of the foot-and-mouth disease, and in
particular in case of vaccination carried out in accordance with
Articles 52 and 53, may be modified in accordance with the
procedure referred to in Article 89(3).

Article 48

Movement control in case of an outbreak of foot-and-
mouth disease

1. Member States shall ensure that in the event of an
outbreak of foot-and-mouth disease on their territory the
following measures to control movement of animals of
susceptible species are applied in the restricted zone established
in accordance with Article 45:

(a) owners shall supply the competent authority, on request
of that authority, with appropriate information concern-
ing animals entering or leaving their holding. That
information shall, in relation to all animals of susceptible
species, include at least the details required by Article 14
of Directive 64/432/EEC;

(b) persons engaged in the transport or marketing of animals
of susceptible species shall supply the competent auth-
ority, on request of that authority, with appropriate
information concerning the movements of such animals
which they have transported or marketed. That infor-
mation shall
include at least the details required by
Articles 12(2) and 13(1)(b) of Directive 64/432/EEC.

2. Member States may extend some or all the measures
provided for in paragraph 1 to a part or the entire free zone.

SECTION 8

VACCINATION

Article 49

Use, manufacture, sales and controls of foot-and-mouth
disease vaccines

Member States shall ensure that:

(a)

(b)

(c)

(d)

the use of
foot-and-mouth disease vaccines and the
administration of hyperimmune sera against foot-and-
mouth disease are prohibited on their territory except as
provided for in this Directive;

the production, storage, supply, distribution and sale of
foot-and-mouth disease vaccines on their territory are
carried out under official control;

the marketing of foot-and-mouth disease vaccines is
under the supervision of the competent authorities in
accordance with Community legislation;

the use of foot-and-mouth disease vaccines for purposes
other than to induce active immunity in animals of
susceptible species, notably laboratory investigations,
scientific research or testing of vaccines, is authorised
by the competent authorities and carried out under
appropriate bio-security conditions.

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Article 50

Article 51

Decision on introducing emergency vaccination

Conditions for emergency vaccination

It may be decided to introduce emergency vaccination

1.
where at least one of the following conditions applies:

(a) outbreaks of foot-and-mouth disease have been con-
firmed and threaten to become widespread in the Member
State where such outbreaks have been confirmed;

(b) other Member States are at risk due to the geographical
situation of or the prevailing meteorological conditions
in relation to reported outbreaks of
foot-and-mouth
disease in a Member State;

(c)

other Member States are at risk due to epidemiologically
relevant contacts between holdings on their territories
and holdings keeping animals of susceptible species in a
Member State where there are outbreaks of foot-and-
mouth disease;

(d) Member States are at risk due to the geographical
situation or the prevailing meteorological conditions in a
neighbouring third country where there are outbreaks of
foot-and-mouth disease.

2. When deciding on the introduction of emergency vacci-
nation, consideration shall be given to the measures provided
for in Article 15 and to the criteria listed in Annex X.

3.
The decision to introduce emergency vaccination shall
be adopted in accordance with the procedure referred to in
Article 89(3).

4.
The decision referred to in paragraph 3 to introduce
emergency vaccination on its own territory may be requested:

(a)

either by the Member State referred to in paragraph 1(a),
or

(b) by a Member State referred to in paragraph 1(b), (c) or

(d).

5.
By way of derogation from paragraph 3, the decision to
introduce emergency vaccination may be taken by the Member
State concerned and implemented in accordance with this
Directive, after a written notification to the Commission which
shall include the specifications provided for in Article 51.

If a Member State introduces emergency vaccination in
6.
accordance with paragraph 5, that decision shall be immedi-
ately reviewed in the Standing Committee on the Food Chain
and Animal Health and Community measures shall be adopted
in accordance with the procedure referred to in Article 89(3).

7.
By way of derogation from paragraph 4, a decision to
introduce emergency vaccination in a Member State referred
to in paragraph (1)(a) may be adopted in concertation with the
affected Member State in accordance with the procedure
referred to in Article 89(3) on the Commission’s own initiative,
if the condition in paragraph (1)(a) and paragraph (1)(b) apply.

1.
The decision to introduce emergency vaccination in
accordance with Article 50(3) and (4) shall specify the
conditions under which such vaccination shall be carried out
and these conditions must specify at least:

(a)

the delimitation in accordance with Article 45 of the
geographical area in which emergency vaccination is to
be carried out;

(b)

the species and the age of the animals to be vaccinated;

(c)

the duration of the vaccination campaign;

(d)

(e)

a specific prohibition on movements of vaccinated and
non-vaccinated animals of susceptible species and their
products;

the special additional and permanent identification and
special registration of the vaccinated animals pursuant to
Article 47(2);

(f)

other matters appropriate to the emergency situation.

2.
The conditions for emergency vaccination as provided
for in paragraph 1, shall ensure that such vaccination is carried
out in accordance with Article 52, irrespective of whether the
vaccinated animals are subsequently slaughtered or stay alive.

3. Member States shall ensure that an information pro-
gramme shall be put in place to inform the public about the
safety of meat, milk and dairy products from vaccinated
animals for human consumption.

Article 52

Protective vaccination

1. Member States applying protective vaccination shall
ensure that:

(a)

(b)

(c)

the vaccination zone shall be regionalised in accordance
with Article 45, where necessary in close cooperation
with neighbouring Member States;

vaccination shall be carried out swiftly and in conformity
with the rules of hygiene and bio-security so as to avoid
the spread of foot-and-mouth disease virus;

all measures applied in the vaccination zone shall be
carried out without prejudice to the measures provided
for in Section 7;

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(d) where the vaccination zone includes parts of or the entire

Article 54

protection or surveillance zone:

(i)

(ii)

the measures applicable for the protection zone or
surveillance zone in accordance with this Directive
shall be maintained within that part of the vacci-
nation zone until such measures have been removed
in accordance with Article 36 or Article 44;

after the measures applied in the protection zone
the
and surveillance zone have been removed,
measures applicable for the vaccination zone as
provided for in Articles 54 to 58 shall continue to
apply.

2. Member States applying protective vaccination shall
ensure that the vaccination zone is surrounded by a surveil-
lance area (surveillance zone as defined by OIE) of at least
10 km width from the perimeters of the vaccination zone:

(a)

in which vaccination is prohibited;

(b)

in which intensified surveillance is carried out;

(c)

in which the movement of animals of susceptible species
is subject to controls by the competent authorities;

(d) which remains in place until the foot-and-mouth disease
and infection free status is recovered in accordance with
Article 61.

Article 53

Suppressive vaccination

1. Member States shall notify the Commission if they decide
in accordance with Article 50 and taking into account all
relevant circumstances, to introduce suppressive vaccination
and shall provide details of the control measures to be taken
which shall include at least those provided for in Article 21.

2. Member States shall ensure that suppressive vaccination
is carried out:

(a) only within a protection zone;

(b) only on clearly identified holdings subject to the measures
provided for in Article 10(1) and in particular subpara-
graph (a) thereof.

However, for logistical reasons and by way of derogation from
Article 10(1)(a), the killing of all animals on such holdings
may be delayed as long as necessary to comply with Directive
93/119/EEC and the provisions of Article 10(1)(c) of this
Directive.

Measures applicable in the vaccination zone during the
period from the beginning of emergency vaccination until
at least 30 days have elapsed following the completion of
such vaccination (Phase 1)

1. Member States shall ensure that the measures provided
for in paragraphs 2 to 6 are applied in the vaccination zone
during the period from the beginning of the emergency
vaccination until at least 30 days have elapsed following the
completion of such vaccination.

2. Movement of live animals of susceptible species shall be
prohibited between holdings within and out of the vaccination
zone.

By way of derogation from the prohibition provided for in the
first subparagraph, and after clinical inspection of such live
animals and the herds of origin or dispatch of those animals,
the competent authorities may authorise their direct transport
for immediate slaughter in a slaughterhouse designated by the
competent authority and situated within the vaccination zone
or in exceptional cases close to that zone.

Fresh meat produced from vaccinated animals slaught-

3.
ered during the period referred to in paragraph 1 shall:

(a)

bear the mark provided for in Directive 2002/99/EC;

(b) be stored and transported separately from meat not
bearing the mark referred to in point (a), and shall
subsequently be transported in sealed containers to an
establishment designated by the competent authorities
for treatment in accordance with point 1 in Part A of
Annex VII.

4. Milk and milk products produced from vaccinated
animals may be placed on the market within or outside the
vaccination zone, provided that, depending on the final use
for either human consumption or non-human consumption,
it has undergone at least one of the treatments referred to in
Parts A and B of Annex IX. The treatment shall be carried out
under the conditions set out in paragraph 5 in establishments
situated in the vaccination zone or, if there is no establishment
in that zone, in establishments situated outside the vaccination
zone to which the raw milk is transported under the conditions
set down in paragraph 7.

Establishments referred to in paragraphs 4 shall comply

5.
with the following conditions:

(a)

(b)

the establishment shall be operated under permanent and
strict official control;

all milk used in the establishment shall either comply
with paragraph 4 or the raw milk shall be obtained from
animals outside the vaccination zone;

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during the whole production process the milk shall be
clearly identified and transported and stored separately
from raw milk and raw milk products which are not
destined for dispatch outside the vaccination zone;

9.
The collection of semen for artificial insemination from
donor animals of susceptible species kept in semen collection
centres situated within the vaccination zone shall be sus-
pended.

(c)

(d)

transport of raw milk from holdings situated outside the
vaccination zone to the establishments shall be carried
out in vehicles which were cleaned and disinfected prior
to the transport operation, and which have had no
subsequent contact with holdings in a restricted zone
keeping animals of susceptible species.

6.
Compliance with the conditions in paragraph 5 shall be
certified by the competent authority for milk intended for intra-
Community trade. The competent authority shall supervise the
control of compliance undertaken by the local veterinary
authority and in the case of intra-Community trade communi-
cate to other Member States and the Commission a list of
those establishments which it has approved for the purpose of
such certification.

7.
Transport of raw milk from holdings situated within
the vaccination zone to establishments situated outside the
vaccination zone and the processing of that milk shall be
subject to the following conditions:

(a) processing in establishments situated outside the vacci-
nation zone of raw milk produced from animals of
susceptible species kept within the vaccination zone shall
be authorised by the competent authorities;

(b)

(c)

the authorisation shall include instructions on and desig-
nation of the transport route to the designated establish-
ment;

transport shall be carried out in vehicles which were
cleaned and disinfected prior to the transport operation,
which are constructed and maintained in such a way that
there is no leakage of milk during transport and which
are equipped to avoid aerosol dispersion during the
loading and unloading of the milk;

(d) before leaving the holding from where milk of animals of
susceptible species was collected, the connection pipes,
tires, wheel cases, the lower parts of the vehicle and any
spillage of milk are cleansed and disinfected and after the
last disinfection and before leaving the vaccination zone
the vehicle had no subsequent contact with holdings in
the vaccination zone keeping animals of susceptible
species;

(e)

the means of transport are strictly assigned to a defined
geographical or administrative area, they are marked
accordingly and may only be moved to another area after
cleansing and disinfection under official supervision.

By way of derogation from the prohibition provided for in the
first subparagraph, the competent authorities may authorise
the collection of semen at semen collection centres within the
vaccination zone for the production of frozen semen, subject
to the following conditions:

(a)

it is ensured that the semen collected during the period
referred to in paragraph 1 is stored separately for at least
30 days, and

(b) prior to dispatch of the semen:

(1)

(2)

either the donor animal has not been vaccinated and
the conditions of Article 28(3)(b) and (c) apply, or

the donor animal has been vaccinated following a
negative test for antibodies against foot-and-mouth
disease virus carried out prior to vaccination; and

(i)

a negative result has been achieved in a test for
the detection of either virus or viral genome or
an approved test for the detection of antibody
against non-structural proteins, carried out at
the end of
the quarantine period for the
semen on samples taken from all animals of
susceptible species present at that time on the
semen collection centre, and

(ii)

the semen complies with the conditions of
Article 4(3) of Chapter II of Directive 88/407/
EEC.

Collection of ova and embryos from donor animals

10.
shall be prohibited.

11.
The placing on the market of products of animal origin
other than those referred to in paragraphs 9 and 10 shall be
subject to the conditions provided for in Articles 30, 31, 32
and 41.

Article 55

Measures applicable in the vaccination zone during the
period from emergency vaccination until the survey and
the classification of holdings are completed (Phase 2)

8.
The collection and transport of samples of raw milk of
animals of susceptible species from holdings situated in the
vaccination zone to a laboratory other than a veterinary
foot-and-
diagnostic laboratory approved for diagnosis of
mouth disease and the processing of
the milk in such
laboratories shall be forbidden.

1. Member States shall ensure that the measures provided
for in paragraphs 2 to 5 are applied in the vaccination zone
during a period starting not earlier than 30 days from the date
of completion of emergency vaccination and terminating with
the completion of the measures provided for in Articles 56
and 57.

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2. Movement of animals of susceptible species between
holdings within and out of the vaccination zone shall be
prohibited.

3.
By way of derogation from the prohibition provided for
in paragraph 2, the competent authorities may authorise direct
transport for immediate slaughter of animals of susceptible
species from holdings referred to in Article 57(5)
to a
slaughterhouse situated within or out of the vaccination zone
on the following conditions:

(a)

(b)

(c)

(d)

during transport and in the slaughterhouse those animals
shall not come into contact with other animals of
susceptible species;

the animals shall be accompanied by an official document
certifying that all animals of susceptible species on the
holding of origin or dispatch have undergone a survey
provided for in Article 56(2);

the transport vehicles shall be cleansed and disinfected
before loading and after the animals have been delivered,
with the date and time of the cleaning and disinfection
being recorded in the logbook of the means of transport;

the animals shall have passed the ante-mortem health
inspection at the slaughterhouse during the 24 hours
before slaughter and have in particular undergone exam-
ination for mouth and feet disease and not shown signs
of that disease.

5.
Compliance with the conditions in paragraph 4 shall be
certified by the competent authority for fresh meat intended
for intra-Community trade. The competent authority shall
supervise the control of compliance undertaken by the local
veterinary authorities and, in the case of intra-Community
trade, communicate to other Member States and the Com-
mission a list of those establishments which it has approved
for the purpose of such certification.

6.
Fresh meat produced from vaccinated porcine animals
slaughtered during the period referred to in paragraph 1 shall
bear the health mark provided for in Directive 2002/99/EC
and shall be stored and transported separately from meat not
bearing that mark and subsequently be transported in sealed
containers to an establishment designated by the competent
authorities for treatment in accordance with point 1 in Part A
of Annex VII.

7. Milk and milk products produced from vaccinated
animals may be placed on the market within or outside the
vaccination zone, provided that depending on the final use for
either human consumption or non-human consumption it has
undergone at least one of the treatments referred to in Parts A
and B of Annex IX. Such treatment shall have been undergone
in an establishment located within or outside the vaccination
zone in accordance with the provisions in Article 54(4) to (8).

8.
For the collection of semen, ova and embryos from
animals of susceptible species, the measures provided for in
Article 54(9) and (10) shall continue to apply.

4.
Fresh meat, excluding offal, produced from vaccinated
large and small ruminants during the period referred to in
paragraph 1, may be placed on the market within and outside
the vaccination zone under the following conditions:

9.
The placing on the market of products of animal origin
other than those referred to in paragraphs 4, 6, 7 and 8 shall
be subject to the conditions provided for in Articles 30, 31,
32 and 41.

(a)

the establishment shall be operated under strict veterinary
control;

Article 56

(b) only fresh meat, excluding offal, which was subjected to
the treatment described in points 1, 3 and 4 in Part A of
Annex VIII or fresh meat obtained from animals reared
and slaughtered outside the vaccination zone shall be
processed in the establishment;

(c)

the health mark in
all such fresh meat shall bear
accordance with Chapter XI of Annex I to Directive 64/
433/EEC or, in the case of meat from other biungulates,
the health mark provided for in Chapter III of Annex I of
Directive 91/495/EEC, or, in the case of minced meat and
the health mark provided for in
meat preparations,
Chapter VI of Annex I of Directive 94/65/EC;

(d)

throughout the production process the fresh meat shall
be clearly identified, and transported and stored separately
from meat of different animal health status in accordance
with this Directive.

Clinical and serological survey in the vaccination zone
(Phase 2-A)

1. Member States shall ensure that the measures provided
for in paragraphs 2 and 3 are applied in the vaccination zone
during a period starting not earlier than 30 days from the date
of completion of emergency vaccination and terminating with
the completion of a clinical and serological survey.

2.
A survey shall be carried out with the aim to identify
herds of animals of susceptible species that had contact with
the foot-and-mouth disease virus without showing overt
clinical signs of the foot-and-mouth disease. That survey shall
inspection of all animals of susceptible
include a clinical
species in all herds in the vaccination zone, and laboratory
testing in accordance with paragraph 3.

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3.
Laboratory testing shall be carried out by use of tests
complying with the criteria for diagnostic tests as set out in
Annex XIII and approved in accordance with the procedure
referred to in Article 89(2), and shall comply with one of the
following conditions:

(a)

(b)

testing for infection with the foot-and-mouth disease
virus, either by an assay for antibodies against non-
structural proteins of the foot-and-mouth disease virus,
or by another approved method, shall meet criteria for
sampling on holdings set out in point 2.2 of Annex III.
Where the competent authorities use in addition sentinel
animals, the conditions for restocking of infected holdings
in Annex V shall be taken into account;

testing for antibodies against non-structural proteins of
the foot-and-mouth disease virus shall be carried out on
samples taken from all vaccinated animals of susceptible
species and their non-vaccinated offspring in all herds in
the vaccination zone.

Article 57

Classification of herds in the vaccination zone
(Phase 2-B)

1. Member States shall ensure that the holdings containing
animals of susceptible species:

(a)

are classified according to the outcome of the survey
referred to in Article 56(2) and the criteria set out in
Annex I;

(b)

comply with the measures set out in paragraphs 2 to 4.

(ii)

the remaining animals of susceptible species
on the holding shall be slaughtered under
conditions authorised by the competent auth-
orities;

(b)

cleansing and disinfection of the holdings in accordance
with Article 11;

(c)

restocking of animals in accordance with Annex V.

4. Member States shall ensure that the following measures
are applied to products derived from animals of susceptible
species and produced during the period referred to in
Article 56(1):

(a)

fresh meat produced from the animals referred to in
paragraph 3(2)(ii) shall be subject to Article 55(4), for
meat from ruminants, and (6), for meat from porcine
animals, respectively;

(b) milk and milk products produced from the animals
referred to in paragraph 3(2)(ii) shall undergo at least one
of the treatments specified in Parts A and B of Annex IX
depending on the intended use and in compliance with
the provisions in Article 54(4) to (8).

5.
Animals of susceptible species on holdings where the
presence of previous or present infection with the foot-and-
mouth disease virus has been officially ruled out in accordance
with Article 56(3) may be subject to the measures provided
for in Article 58.

Article 58

2.
Holdings containing at least one animal suspected of
being infected and where the presence of foot-and-mouth
disease virus is confirmed in accordance with the criteria laid
down in Annex I shall be subject to the measures provided for
in Articles 10 and 21.

Measures applicable in the vaccination zone after the
completion of the survey and the classification of holdings
until the foot-and-mouth disease and infection free status
is recovered (Phase 3)

3.
Holdings containing at least one animal of susceptible
species suspected of being infected through previous contact
with the foot-and-mouth disease virus but where further
testing including all animals of susceptible species present on
the holding confirmed the absence of circulating foot-and-
mouth disease virus shall be subject to at least the following
measures:

(a)

animals of susceptible species on the holding shall:

(1)

either be killed and the carcasses processed, or

(2)

the animals shall be classified and

(i)

the animals positive to at least one of the
approved tests referred to in Article 56(3) shall
be killed and their carcasses processed, and

1. Member States shall ensure that the measures provided
for in paragraphs 2 to 6 are applied in the vaccination zone
after the completion of the measures laid down in Article 57
and until the foot-and-mouth disease and infection-free status
has been recovered in accordance with Article 59.

2. Member States shall ensure that movement of animals of
susceptible species between holdings situated in the vacci-
nation zone is subject to authorisation.

3. Movement of animals of susceptible species out of the
vaccination zone shall be prohibited. By way of derogation
from this prohibition, direct transport to a slaughterhouse for
immediate slaughter of animals of susceptible species may be
authorised under the conditions provided for in Article 55(3).

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4.
By way of derogation from the prohibition in para-
graph 2, the competent authorities may authorise the transport
of unvaccinated animals of susceptible species in accordance
with the following provisions:

(a) within 24 hours of loading, all animals of susceptible
species on the holding have been subjected to clinical
examination and have not shown clinical signs of foot-
and-mouth disease, and

(b)

(c)

(d)

the animals have completed a standstill on the holding of
origin of at least 30 days during which no animal of
susceptible species has been introduced onto the holding,
and

the holding of origin is not situated in a protection or
surveillance zone, and

the animals intended for transport were either individu-
ally subjected with negative results to tests for the
detection of antibodies against the foot-and-mouth dis-
ease virus at
the end of the isolation period, or a
serological survey was completed on that holding in
accordance with point 2.2 of Annex III irrespective of the
species concerned;

(e)

the animals were not exposed to any source of infection
during their transportation from the holding of origin to
the place of destination.

Non-vaccinated offspring of vaccinated dams shall be
5.
prohibited from leaving the holding of origin unless being
transported to:

(a)

a holding within the vaccination zone of the same health
status as the holding of origin;

(b)

a slaughterhouse for immediate slaughter;

(c)

(d)

a holding designated by the competent authority, from
which the offspring are to be sent directly to the
slaughterhouse;

any holding, after having obtained a negative result in a
serological test for the detection of antibody against the
foot-and-mouth disease virus carried out on a sample of
blood taken prior to dispatch from the holding of origin.

(b)

the establishment shall be operated under strict veterinary
control;

(c)

(d)

only fresh meat produced from animals referred to in
point
(a) or from animals reared and/or slaughtered
outside the vaccination zone or fresh meat referred to in
paragraph 8 shall be processed in the establishment;

all such fresh meat shall bear the health mark in
accordance with Chapter XI of Annex I to Directive 64/
433/EEC or in the case of meat from other biungulates,
the health mark provided for in Chapter III of Annex I of
Directive 91/495/EEC, or in the case of minced meat and
meat preparations the health mark provided for in
Chapter VI of Annex I of Directive 94/65/EC;

(e)

throughout the production process the fresh meat shall
be clearly identified, and transported and stored separately
from meat of different animal health status in accordance
with this Directive.

7.
Fresh meat produced from vaccinated animals of suscep-
tible species or from non-vaccinated seropositive offspring of
vaccinated dams slaughtered during the period referred to in
paragraph 1 shall bear the health mark provided for in
Directive 2002/99/EC and shall be stored and transported
separately from meat not bearing that stamp and subsequently
be transported in sealed containers to an establishment
designated by the competent authorities for treatment in
accordance with point 1 in Part A of Annex VII.

8.
By way of derogation from paragraph 7, fresh meat and
trimmed offal produced from vaccinated large and small
ruminants or their non-vaccinated seropositive offspring may
be placed on the market within and outside the vaccination
zone under the following conditions:

(a)

the establishment shall be operated under strict veterinary
control;

(b) only fresh meat excluding offal, which was subjected to
the treatment described in point 1, 3 and 4 in Part A of
Annex VIII or fresh meat referred to in paragraph 6 or
produced from animals reared and/or slaughtered outside
the vaccination zone are processed in the establishment;

6.
Fresh meat produced from unvaccinated animals of
susceptible species may be placed on the market inside and
outside the vaccination zone under the following conditions:

(c)

(a)

either the measures provided for in Article 57(3) have
been completed in the entire vaccination zone or the
animals are transported to the slaughterhouse under the
conditions provided for in paragraph 3 or 4(d), and;

all such fresh meat shall bear the health mark in
accordance with Chapter XI of Annex I to Directive 64/
433/EEC or in the case of meat from other biungulates
the health mark provided for in Chapter III of Annex I to
Directive 91/495/EEC, or in the case of minced meat and
meat preparations the health mark provided for in
Chapter VI of Annex I to Directive 94/65/EC;

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(d)

throughout the production process the fresh meat shall
be clearly identified, and transported and stored separately
from meat which is of different animal health status in
accordance with this Directive.

9.
By way of derogation from paragraph 7, fresh meat
from vaccinated porcine animals and their non-vaccinated
seropositive offspring, produced during the period from the
beginning of the survey until the measures provided for in
Article 57 have been completed in the entire vaccination zone
and until at least 3 months have elapsed after the last outbreak
recorded in that zone, may only be placed on the national
market of the Member State of origin within and outside the
vaccination zone under the following conditions:

(a)

the establishment shall be operated under strict veterinary
control;

(b) only fresh meat from animals originating in holdings
complying with the conditions in Article 57(5) or fresh
meat obtained from animals reared and slaughtered
outside the vaccination zone are processed in the estab-
lishment;

(c)

all such fresh meat shall bear a health mark to be decided
in accordance with Article 4(3) of Directive 2002/99/EC;

(d)

throughout the production process the fresh meat shall
be clearly identified, and transported and stored separately
from meat of different animal health status in accordance
with this Directive.

10.
A Member State other than the Member State referred
to in paragraph 9 may request a decision in accordance with
the procedure provided for in Article 89(3) to extend the
marketing of the meat referred to in paragraph 9 to its territory
or part of its territory under conditions to be laid down under
the same procedure.

11.
The rules for dispatch from the vaccination zone of
fresh meat from vaccinated porcine animals produced after the
period referred to in paragraph 9 until free status has been
regained in accordance with Article 61, shall be decided in
accordance with the procedure provided for in Article 89(3).

12.
Compliance with the conditions provided for in para-
graph 6, paragraph 8 and where applicable under the pro-
visions of paragraph 10, shall be certified by the competent
authority for fresh meat intended for intra-Community trade.
The competent authority shall supervise the control of com-
pliance undertaken by the local veterinary authorities and shall
in the case of intra-Community trade communicate to other

Member States and the Commission a list of those establish-
ments which they have approved for such certification.

13.
By way of derogation from paragraph 8 a special health
mark which cannot be confused with the health mark referred
to in paragraphs 8(c) and 9(c), may be decided in accordance
with the procedure referred to in Article 89(3) for fresh meat
of ruminants not subjected to the treatment in accordance
with Part A of Annex VIII, and minced meat and meat
preparations produced from such meat, which are intended
for placing on the market in the a specific region of the
Member State of origin.

14. Milk and milk products produced from vaccinated
animals may be placed on the market within and outside the
vaccination zone, provided that depending on the final use for
either human consumption or non-human consumption it has
undergone at least one of the treatments referred to in Parts A
and B of Annex IX. Such treatment shall have been undergone
in an establishment located in the vaccination zone or in
accordance with the provisions in Article 54(4) to (7).

15.
The collection and transport of samples of raw milk of
animals of susceptible species, from holdings situated in the
surveillance zone to a laboratory other than a veterinary
diagnostic laboratory approved for diagnosis of
foot-and-
mouth disease, and the processing of the milk in such
laboratories, shall be subject to official authorisation and to
appropriate measures to avoid any possible spread of foot-
and-mouth disease virus.

16.
The placing on the market of products of animal origin
other than those referred to in paragraphs 6 to 11 and 13 to
15 shall be subject to the conditions provided for in Articles 30,
31, 32 and 42.

SECTION 9

RECOVERY OF THE FOOT-AND-MOUTH DISEASE AND
INFECTION FREE STATUS

Article 59

Recovery of the foot-and-mouth disease and infection
free status

The foot-and-mouth disease and infection free status of a
Member State or a region thereof shall be recovered in
accordance with the procedure referred to in Article 89(3),
taking into account the conditions referred to in Articles 60
and 61.

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Article 60

Recovery of status following eradication of foot-and-
mouth disease without emergency vaccination

A Member State or region of a Member State regionalised
1.
in accordance with Article 45 shall recover its previous foot-
and-mouth disease and infection free status following the
control and eradication of one or more outbreaks of foot-
and-mouth disease without vaccination under the following
conditions:

(a)

all the measures provided for in Articles 36 and 44 have
been completed, and

(b)

at least one of the following conditions applies:

(i)

(ii)

the relevant recommendations in the foot-and-
mouth disease Chapter, as last amended, of the
Animal Health Code of the OIE are met;

at least three months have elapsed after the last
recorded outbreak of foot-and-mouth disease and
clinical and laboratory surveillance carried out in
accordance with Annex III has confirmed the
absence of infection with the foot-and-mouth dis-
ease virus in the Member State or region concerned.

2.
Decisions on recovering a foot-and-mouth disease and
infection-free status shall be adopted in accordance with the
procedure referred to Article 89(3).

Article 61

Recovery of status following eradication of foot-and-
mouth disease with vaccination

A Member State or region of a Member State regionalised
1.
in accordance with Article 45 shall recover its previous foot-
and-mouth disease and infection free status following the
control and eradication of one or more outbreaks of foot-
and-mouth disease with vaccination under the following
conditions:

(a)

all the measures provided for in Articles 36, 44, 54, 55,
56 and 57 have been completed, and

(b)

at least one of the following conditions applies:

(iii) at

least six months have elapsed since the last
outbreak of foot-and-mouth disease or the com-
pletion of emergency vaccination, what ever event
occurred later, and in accordance with the guidelines
established in accordance with Article 70(3), a
serological survey based on the detection of anti-
bodies against non-structural proteins of the foot-
and-mouth disease virus has demonstrated the
absence of infection in vaccinated animals.

Decisions on recovering a foot-and-mouth and infection-
2.
free status shall be adopted in accordance with the procedure
referred to Article 89(3).

Article 62

Modifications of measures to recover the foot-and-mouth
disease and infection-free status

1.
By way of derogation from Article 60 it may be decided
in accordance with the procedure referred to in Article 89(3),
to withdraw the restrictions applied in accordance with this
Directive after the requirements provided for in Articles 36
and 44 have been met and the clinical and serological survey
has been completed and confirmed the absence of foot-and-
mouth disease virus infection.

2.
By way of derogation from Article 61 it may be decided
in accordance with the procedure referred to in Article 89(3),
to withdraw the restrictions applied in accordance with this
Directive after the clinical and serological survey provided for
in Article 56 and the measures provided for in Article 57 have
been completed and confirmed the absence of foot-and-mouth
disease virus infection.

3. Without prejudice to paragraphs 1 and 2 it may be
decided in accordance with the procedure referred to in
Article 89(3) that no animals of a susceptible species shall be
removed from the territory or region of the Member State
where the outbreak of foot-and-mouth disease has occurred to
another Member State until the foot-and-mouth disease and
infection free status is recovered in accordance with the
conditions of the Animal Health Code of the OIE, unless such
animals:

(i)

(ii)

the relevant recommendations in the foot-and-
mouth disease Chapter, as last amended, of the
Animal Health Code of the OIE are met;

(a) have not been vaccinated and are consigned directly to a

slaughter house for immediate slaughter; or

at least three months have elapsed since the slaughter
of the last vaccinated animal and serological surveil-
lance has been carried out in accordance with the
guidelines
accordance with
Article 70(3);

established

in

(b) have been isolated for at least 30 days immediately prior
to loading and have undergone a serological test for the
detection of antibody against foot-and-mouth disease
virus structural proteins, carried out with negative results
on samples taken during the 10 days prior to loading.

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4. Without prejudice to paragraph 2 it may be decided in
accordance with the procedure referred to in Article 89(3) that
until the foot-and-mouth disease and infection free status is
recovered in accordance with the conditions of the Animal
Health Code of the OIE the radius of the surveillance area
around the vaccination zone referred to in Article 52(2) shall
be reduced after the completion with satisfactory results of the
measures provided for in Article 57.

Article 63

Certification of animals of susceptible species and prod-
ucts derived from such animals for intra-Community
trade

Member States shall ensure that additional certification for
intra-Community trade in animals of susceptible species or
products derived from such animals required in accordance
with this Directive shall be continued until the foot-and-mouth
disease and infection free status of the Member State or part of
the territory of a Member State has been recovered in
accordance with Articles 60 and 61.

(a)

(b)

(c)

laboratories and establishments in which live foot-and-
mouth disease virus,
its genome, antigens or vaccines
produced from such antigens are handled for research,
diagnosis or manufacture are strictly controlled by the
competent authorities;

the handling of live foot-and-mouth disease virus for
research and diagnosis is carried out only in approved
laboratories listed in Part A of Annex XI;

the handling of live foot-and-mouth disease virus for the
manufacturing of either inactivated antigens for the
production of vaccines or vaccines and related research is
carried out only in the approved establishments and
laboratories listed in Part B of Annex XI;

(d)

the laboratories and establishments referred to in points
(b) and (c) are operated at least according to the bio-
security standards set out in Annex XII.

Article 66

Article 64

Checks of laboratories and establishments handling live
foot-and-mouth disease virus

Movement of vaccinated animals of susceptible species
after the recovery of the foot-and-mouth disease and
infection-free status

1.
The dispatch from one Member State to another Member
State of animals of susceptible species vaccinated against foot-
and-mouth disease shall be prohibited.

2.
By way of derogation from the prohibition in para-
graph 1, it may be decided in accordance with the procedure
referred to in Article 89(2) to adopt specific measures with
regard to vaccinated animals of susceptible species kept in
zoos and included in a programme for wildlife conservation
or kept on premises for farm animal resources that have been
listed by the competent authorities as breeding nucleus of
animals indispensable for the survival of the breed, subject to
appropriate provisions in the Animal Health Code of the OIE.

CHAPTER III

PREVENTATIVE MEASURES

SECTION 10

Veterinary experts from the Commission,
in collaboration
with the competent authorities of the Member States, shall
carry out spot-checks to ascertain whether the security systems
applied in the establishments and laboratories referred to in
Parts A and B of Annex XI comply with the bio-security
standards set out in Annex XII.

Article 67

Modification of the list of approved laboratories and
establishments handling live foot-and-mouth disease virus

1.
The list of establishments and laboratories in Part A and
B of Annex XI may be amended in accordance with the
procedure referred to in Article 89(3), in the light of the spot-
checks provided for in Article 66.

The list of establishments and laboratories in Part A and
2.
B of Annex XI shall be regularly updated based on written
information submitted by the Member States, in accordance
with the procedure referred to in Article 89(2).

LABORATORIES AND ESTABLISHMENTS HANDLING FOOT-
AND-MOUTH DISEASE VIRUS

Article 65

Article 68

National Laboratories

Laboratories and establishments handling live foot-and-
mouth disease virus

Member States shall ensure that:

1. Member States shall ensure that:

(a)

laboratory testing for foot-and-mouth disease is carried
out in laboratories authorised for such testing by the
competent authorities;

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(b)

(c)

(d)

(e)

laboratory testing to confirm the presence of foot-and-
mouth disease virus or other vesicular disease viruses is
carried out in accordance with Article 71 by one of the
laboratories listed in Part A of Annex XI;

one of the laboratories listed in Part A of Annex XI shall
be designated as the national reference laboratory for the
Member State on whose territory it is situated, and it shall
be responsible for coordinating standards and methods
of diagnosis in that Member State;

the national reference laboratory carries out at least the
functions and duties set out in Annex XV;

the national reference laboratory referred to in point (c)
liases with the Community Reference Laboratory pro-
vided for in Article 69 and in particular ensures the
sending of appropriate samples to the Community Refer-
ence Laboratory.

2.
The national reference laboratory referred to in para-
graph 1(c) of one Member State may provide the services of a
national reference laboratory to one or more other Member
States. Member States which have no national reference
laboratory situated on their territory may use the services of
the national reference laboratory in one or more other Member
States.

That cooperation shall be formalised in a mutual agreement
between the competent authorities of the Member States
concerned, which shall be notified to the Commission. Such
cooperation shall be listed in the special column in the table in
Part A of Annex XI.

3. Member States shall ensure that laboratory investigations
provided for in this Directive are first of all carried out to
confirm or rule out foot-and-mouth disease and to exclude
other vesicular diseases.

Where an outbreak of
foot-and-mouth disease has been
confirmed and the serotype of the virus was identified, that
virus shall be antigenically characterised in relation to the
reference vaccine strains, where necessary with the assistance
of the Community Reference Laboratory.

Samples from domestic livestock showing signs of vesicular
disease which are negative for foot-and-mouth disease virus
and, where relevant, Swine Vesicular Disease virus shall be
sent to the Community Reference Laboratory for further
investigation.

Article 69

Community Reference Laboratory

1.
The Community Reference Laboratory shall be desig-
nated in agreement with the laboratory concerned and in
accordance with the procedure referred to in Article 89(2), for
a period to be determined under that procedure.

2. When designating a Community Reference Laboratory,
the technical and scientific competence of the laboratory as
well as the expertise and excellence of the scientific and
technical staff employed shall firstly be taken into account.

3.
The Commission shall review the designation of the
Community Reference Laboratory by the end of the designated
period of operation or earlier in the light of its compliance
with the functions and duties of the Community Reference
Laboratory specified in Annex XVI.

Article 70

Security standards and guidelines for surveillance, code
of conduct for approved laboratories and establishments
handling live foot-and-mouth disease virus

1.
An Operational Manual for Minimum Standards for
Laboratories working with the foot-and-mouth disease virus
in vitro and in vivo may be adopted in accordance with the
procedure referred to in Article 89(2).

2.
Guidelines for the surveillance required to recover the
foot-and-mouth disease and infection free status may be
adopted in accordance with the procedure referred to in
Article 89(2).

A uniform code of good conduct for the security systems
3.
applied in the establishments and laboratories listed in Parts A
and B of Annex XI may be adopted in accordance with the
procedure referred to in Article 89(2).

SECTION 11

DIAGNOSIS OF FOOT-AND-MOUTH DISEASE

Article 71

4. Member States shall ensure that the national reference
laboratory on their territory is adequately equipped and staffed
with the appropriate numbers of trained personnel to carry
out the laboratory investigations required in accordance with
this Directive.

Standards and tests for the diagnosis of foot-and-mouth
disease and for the differential diagnosis of other vesicular
diseases

1. Member States shall ensure that the national laboratories
use the tests and standards for diagnosis set out in Annex XIII.

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A decision regarding the suitable arrangements for the
2.
purchase, storage and supply to national
laboratories of
sufficient quantities of specific reagents or diagnostic tests in
case of an emergency, in particular with regard to the measures
provided for in Article 56(3) may be adopted in accordance
with the procedure referred to in Article 89(2).

5.
The criteria and requirements for drawing up the contin-
gency plan shall be those set out in Annex XVII. Those criteria
and requirements may be amended taking into account the
specific nature of foot-and-mouth disease and progress made
in the development of disease control and environmental
protection measures in accordance with the procedure referred
to in Article 89(2).

3.
An Operational Manual for the diagnosis of foot-and-
mouth disease and the differential diagnosis of vesicular
diseases other than swine vesicular disease may be adopted in
accordance with the procedure referred to in Article 89(2).

6.
The Commission shall examine the contingency plans in
order to determine whether they permit the objective provided
to
for in paragraph 1 to be attained and shall suggest
the Member State concerned any amendments required, in
particular to ensure that such plans are compatible with those
of the other Member States.

SECTION 12

The contingency plans shall be approved in accordance

7.
with the procedure referred to in Article 89(2).

CONTINGENCY PLANS AND REAL TIME ALERT EXERCISES

Article 72

Contingency plans

1. Member States shall draw up a contingency plan specify-
ing the national measures required to maintain a high level of
foot-and-mouth disease awareness and preparedness, and
environmental protection and to be implemented in the event
of an outbreak of foot-and-mouth disease.

equipment, personnel

The contingency plan shall provide for the access to all
2.
facilities,
appropriate
materials necessary for the rapid and efficient eradication
of an outbreak of foot-and-mouth disease,
it shall ensure
coordination with neighbouring Member States and encourage
cooperation with neighbouring third countries.

and other

8. Member States shall ensure that significant modifications
in their approved contingency plans are notified to the
Commission without delay.

9.
The revised contingency plans may subsequently be
approved in accordance with the procedure referred to in
to take into account developments in the
Article 89(2),
situation.

10.
In any case, every five years each Member State shall
update its contingency plan in particular in the light of real-
time alert exercises referred to in Article 73, and submit it to
the Commission for approval in accordance with the procedure
referred to in Article 89(2).

3.
The contingency plan shall provide for measures to be
implemented in the event of a worst case scenario as referred
to in point 12 of Annex XVII and shall give indications of:

Article 73

Real-time alert exercises

the vaccine requirements considered necessary in the
event of emergency vaccination, and

1. Member States shall ensure that real-time alert exercises
are carried out in accordance with their approved contingency
plan and Annex XVII.

the regions containing densely populated livestock areas,
taking into account the criteria set down in Annex X.

4.
The contingency plan shall ensure that all necessary
arrangements are made to prevent any avoidable damage to
the environment in the event of an outbreak, while ensuring
at the same time the highest disease control level, and minimise
any damage caused as a result of an outbreak, in particular if it
is necessary to bury or burn the carcasses of dead or killed
animals on site.

2. Member States shall ensure that, where possible and
practical, real-time alert exercises are carried out in close
collaboration with the competent authorities of neighbouring
Member States or third countries.

3. Member States shall inform the Commission about the
main results of real-time alert exercises. That information shall
be submitted to the Commission as part of the information
required in Article 8 of Directive 64/432/EEC.

(a)

(b)

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SECTION 13

Article 75

CONTROL CENTRES AND EXPERT GROUPS

National/Central disease control centres — Technical
requirements

Article 74

National/Central disease control centres — Functions and
duties

1. Member States shall ensure that a fully functional
national/central disease control centre may be immediately
established in the event of foot-and-mouth disease outbreaks.

2.
The national/central disease control centre shall first of
all direct and monitor the operations of local disease control
centres as provided for in Article 76. Certain functions
originally attributed to the national/central disease control
centre may subsequently be transferred to the local disease
control centre operated at the administrative level provided
for in Article 2(2)(p) of Directive 64/432/EEC or higher
provided that the tasks of the national disease control centre
are not compromised.

The national/central disease control centre shall be at

3.
least responsible for:

(a)

designing the necessary control measures;

(b)

(c)

ensuring the prompt and efficient implementation of
those measures by the local disease control centres;

deploying staff and other resources to local disease
control centres;

(d) providing information to the Commission, to the com-
petent authorities of other Member States and other
national authorities including competent environmental
authorities and bodies, as well as veterinary, agricultural
and trading organisations and bodies;

(e)

organising an emergency vaccination campaign and also
the delimitation of vaccination zones;

(f)

liasing with diagnostic laboratories;

(g)

liasing with competent environmental authorities to
coordinate the actions on veterinary and environmental
safety;

(h)

liasing with the media;

(i)

liasing with the enforcement bodies to ensure adequate
implementation of specific legal measures.

1. Member States shall ensure that the national/central
disease control centres have all the necessary means including
staff, facilities and equipment, to manage an efficient eradi-
cation campaign.

The means referred to in paragraph 1 shall include at

2.
least the following:

(a)

(b)

(c)

a herd identifier and animal location system, preferably
computerised;

all suitable means of communication including tele-
phones, fax and if possible facilities for communication
with the media;

a communication system allowing exchange of infor-
mation with the local disease control centres, the labora-
tories and other relevant organisations, preferably com-
puterised;

(d) maps and other sources of information that can be used

in directing control measures;

(e)

(f)

(g)

a shared daily journal which shall be maintained to record
in chronological order all the events associated with
an outbreak of foot-and-mouth disease and allowing
different activities to be linked and coordinated;

lists of national and international organisations and
laboratories that are interested in an outbreak of foot-
and-mouth and shall be contacted in such an event;

lists of staff and other persons who may be called upon
immediately to serve at local disease control centres or in
expert groups provided for in Article 78 in the event of
an outbreak of foot-and-mouth disease;

(h)

lists of competent environmental protection authorities
and bodies to contact in the event of an outbreak of foot-
and-mouth disease;

(i) maps identifying appropriate processing site areas;

(j)

(k)

lists of treatment and processing undertakings authorised
to treat or process animal carcasses and animal waste that
could be commissioned in the event of an outbreak of
indicating their
foot-and-mouth disease,
capacity, address and other contact details;

in particular,

lists of measures to monitor and control disinfectant run-
off as well as body tissue and fluid displacement into
the surrounding environment as a result of carcass
decomposition, particularly into surface waters and
groundwaters.

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Article 76

Local disease control centres — set-up, functions and
duties

1. Member States shall ensure that fully functional local
disease control centres may be established immediately in the
event of outbreaks of foot-and-mouth disease.

2. Member States shall ensure that within the framework of
their contingency plans provisions are made for likely locations
of
their organisation, staff,
accommodation, facilities and equipment, management sys-
tems, communication lines as well as information channels.

local disease control centres,

3. Member States shall ensure the local disease control
centres act in close coordination and cooperation with the
national/central disease control centre, in particular in relation
to the measures provided for in Article 74(3)(b).

4. Member States shall ensure that local disease control
centres have the necessary organisation to ensure the prompt
implementation of the measures provided for in this Directive
to be applied in the event of an outbreak of foot-and-mouth
disease.

Article 77

Local disease control centres — Technical requirements

1. Member States shall ensure that the local disease control
centres have staff, facilities and equipment as required, and a
clear management structure and effective management
to
ensure the prompt implementation of the measures relating
inquiry, environmental protection,
to the epidemiological
processing of carcasses from infected herds, official surveil-
lance of the zones, tracing, welfare and emergency slaughter,
cleansing and disinfection and others measures of sanitation,
emergency vaccination, and all other policy decisions.

(d)

(e)

(f)

a shared daily journal which shall be maintained to record
in chronological order all the events associated with
an outbreak of foot-and-mouth and allowing different
activities to be linked and coordinated;

up-to-date lists of persons, including private veterinarians,
and local organisations in each region who shall be
contacted and may be involved in the event of an
outbreak of foot-and-mouth disease;

up-to-date lists of holdings to which the provisions of
Article 15 and 18 may be applied in the case of an
outbreak of foot-and-mouth disease;

(g) up-to-date inventories of possible burning or burial places
for animals killed in accordance with this Directive and
to be processed in accordance with Community and
national legislation on the protection of the environment;

(h) up-to-date list of competent environmental authorities in
each region, as well as other environmental bodies who
must be contacted and are to be involved in the event of
an outbreak of foot-and-mouth disease;

(i) maps identifying suitable disposal sites for burial of
carcasses that will not present a risk of harm to the
environment, in particular to surface waters or groundwa-
ters;

(j)

(k)

list of treatment and disposal undertakings authorised to
treat or dispose of animal carcasses and animal waste;

list of measures to monitor and control disinfectant run-
off as well as body tissue and fluid displacement into
the surrounding environment as a result of carcass
decomposition, particularly into surface waters and
groundwaters.

Article 78

Expert Group

2.

The local disease control centres shall have at least:

(a) one telephone line reserved for communication with the
national disease control centre accessible phone lines
where farmers and other rural residents can obtain recent,
accurate information about the measures taken;

1. Member States shall create a permanently operational
expert group, which is composed of epidemiologists, vet-
erinary scientists and virologists in a balanced way, to maintain
expertise in order to assist the competent authority in ensuring
preparedness against an outbreak of foot-and-mouth disease.

(b)

(c)

field staff equipped with necessary tools for communi-
cation and effective management of all necessary data;

a record system, preferably computer-based, connected
to the national disease control centre and to all necessary
databases, laboratories and other organisations;

By way of derogation from the first subparagraph, Member
States with a limited number of animals of susceptible species
may arrange a formalised agreement with other Member States
on mutual assistance in regard of the expert group. These
arrangements shall be detailed in the contingency plans
referred to in Article 72.

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In case of a suspicion of an outbreak of foot-and-mouth

2.
disease the expert group shall at least:

(a)

(b)

evaluate the clinical picture and the epidemiological
situation;

give advice regarding the sampling and analyses needed
for diagnosing the foot-and-mouth disease together with
the additional actions and measures to be taken.

2. Member States may retain establishments for the packag-
ing and storage of vaccines in the case of emergency vacci-
nation.

3. Member States shall ensure that the antigen and formu-
lated vaccine in the national antigen and vaccine banks comply
with the minimum standards laid down for the Community
antigen and vaccines bank with respect to safety, sterility and
content of non-structural proteins.

In case of an outbreak of foot-and-mouth the expert

3.
group shall at least:

(a)

conduct at least in the index case and if necessary on the
spot, an evaluation of the clinical picture and an analysis
of the epidemiological inquiry in order to collect the
necessary data for determining:

(i)

the origin of the infection;

(ii)

the date of introduction of the infectious agent;

(iii)

the possible spread of the disease;

(b)

(c)

report to the Chief Veterinary Officer and the national
disease control centre;

give advice on screening, sampling,
test procedures,
control and the other measures to be applied and on the
strategy to be implemented,
including advice on bio-
security measures on holdings or on premises referred to
in Article 16, and in relation to emergency vaccination;

(d)

follow up and guide the epidemiological inquiry;

(e)

(f)

(g)

supplement the epidemiological data with geographical,
meteorological and other necessary information;

analyse the epidemiological data and perform risk assess-
ments at regular intervals;

assist in ensuring that the processing of animal carcasses
and animal waste is done with a minimum of detrimental
effect on the environment.

SECTION 14

ANTIGEN AND VACCINE BANKS

Article 79

National antigen and vaccine banks

4. Member States maintaining a national antigen and
vaccine bank shall inform the Commission about the antigen
and vaccine stocks kept. Such information shall be submitted
to the Commission every 12 months as part of the information
required by Article 8 of Directive 64/432/EEC. The information
on quantities and subtypes of antigens or authorised vaccines
stored in the national antigen and vaccine bank shall be
treated as classified information and in particular shall not be
published.

Article 80

Community antigen and vaccine bank

1.
A Community antigen and vaccine bank shall be estab-
lished in accordance with the procedure referred to in
Article 89(2).

2.
The Commission shall ensure that Community reserves
of concentrated inactivated antigens for the production of foot-
and-mouth disease vaccines are maintained on the premises of
the Community antigen and vaccine bank. For that purpose,
the number of doses and the diversity of strains and subtypes
of antigen of foot-and-mouth disease virus and, if necessary, of
authorised in accordance with Directive 2001/82/EC vaccines
stored in the Community antigen and vaccine bank shall be
decided in accordance with the procedure referred to in
Article 89(2), taking into account the needs as estimated in the
context of the contingency plans provided for in Article 72
and the epidemiological situation, where appropriate after
consultation with the Community Reference Laboratory.

3.
The information on quantities and subtypes of antigens
or authorised vaccines stored in the Community antigen and
vaccine bank shall be treated as classified information and in
particular shall not be published.

The conditions for the establishment and maintenance
4.
of Community reserves of antigen and authorised vaccines
at the premises of preferably at least two manufacturing
establishments shall be laid down in contracts concluded
between the Commission and the manufacturing establish-
ments. Such contracts shall include at least:

1. Member States may within the framework of the contin-
gency plan establish or maintain national antigen and vaccine
banks for the storage of reserves for emergency vaccination of
antigens or vaccines authorised in accordance with Directive
2001/82/EC.

(a)

(b)

conditions for supply of quantities and subtypes of
concentrated inactivated antigen;

conditions for secure storage of antigen and authorised
vaccines;

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(c)

guarantees and conditions of rapid formulation, pro-
duction, bottling, labelling and distribution of vaccines.

5.
The conditions and guarantees referred to in para-
graph 4(a) to (c) may be amended in accordance with the
procedure referred to in Article 89(3).

Article 81

Supply and storage of concentrated inactivated antigen

The Commission shall ensure that the contracted manufacturer
of the concentrated inactivated antigen supplied to the Com-
munity antigen and vaccine bank, guaranties conditions for
the supply and storage of concentrated inactivated antigen of
the foot-and-mouth disease virus at least equivalent to those
laid down in point 1 of Annex XIV.

Article 82

Formulation, production, bottling, labelling and distri-
bution of vaccine

1.
The Commission shall ensure that the contracted manu-
facturer of the concentrated inactivated antigen supplied to the
Community antigen and vaccine bank guaranties conditions
for the formulation, finishing, bottling, labelling and delivery
of vaccines reconstituted from antigens referred to in Article 81
at least equivalent to those laid down in point 2 of Annex XIV.

2.
In case of emergency and with due regard to the
epidemiological situation, the Commission shall be authorised
to arrange for the immediate production, bottling, labelling,
temporary storage and distribution of necessary quantities of
vaccines reconstituted from any suitable antigen.

Article 83

Access to the Community antigen and vaccine bank

1. Member States shall have access to the Community
antigen and vaccine bank following a request to the Com-
mission.

The Commission shall, within the limits of the Community
reserves of antigens and vaccines, immediately arrange for the
formulation, production, bottling, labelling and distribution of
the required quantities and subtypes of vaccines, in particular
in application of Article 51.

2. Member States that maintain a national antigen and
vaccine bank or Member States that are associated to an
international antigen and vaccine bank shall have the same
rights and obligations to the Community antigen and vaccine
bank as other Member States without such reserves.

3. Where it is in the interest of the Community, the
Commission may supply or lend to third countries antigens
from the Community reserves or vaccines reconstituted from
such antigens.

Without prejudice to agreements concluded between the
Community and third countries, access of third countries to
the Community antigen and vaccine bank shall be authorised
in accordance with the procedure referred to in Article 89(2),
subject to detailed arrangements between the Commission and
the third country concerned on the financial and technical
cooperation to be adopted under that procedure.

4.
Following the use of the antigen or formulated vaccine
from the Community reserves, the Commission shall ensure
that the used antigen or vaccine is replaced as soon as possible
and according to the epidemiological situation.

Article 84

Testing of foot-and-mouth disease vaccines

1.
The Commission shall be responsible for arranging
independent testing for potency and innocuity of vaccines
reconstituted from antigen stored in the Community antigen
and vaccine bank, and of vaccines reconstituted from other
antigens and intended for use within the framework of
Community assistance to control measures against
foot-
and-mouth disease in third countries in accordance with
Articles 82(2) and 83(3).

2.
For the purpose of the testing referred to in paragraph 1
the Commission may employ the services of an independent
Community Coordinating Institute.

If necessary, the Community Coordinating Institute shall be
designated, and detailed rules on its functions, responsibilities
and Community financial contributions shall be adopted, in
accordance with the procedure referred to in Article 89(2).

3. Without prejudice to the standards for potency, safety
and production procedures provided for in Community legis-
lation, vaccines reconstituted from antigen stored within the
Community antigen and vaccine bank shall meet at least
the minimum standards for potency, safety and production
procedures laid down in the European Pharmacopoeia and the
relevant provisions of the OIE Manual.

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SECTION 15

FOOT-AND-MOUTH DISEASE IN OTHER SPECIES

Member States shall notify those provisions to the Commission
by the date specified in Article 93(1) at the latest and shall
notify it without delay of any subsequent amendment affecting
them.

Article 85

Article 87

Additional measures to prevent and control foot-and-
mouth disease

Procedures for implementing specific articles, for the
adoption of further detailed rules for the implementation
of this Directive and for amending the Annexes

1. Without prejudice to Regulation (EC) No 1774/2002,
and any implementing legislation, Member States shall ensure
that the prohibition on swill feeding in accordance with
Community and national legislation is applicable to all animals
irrespective of their use or the place inhabited by these animals.
Detailed rules for the control measures to be applied by
Member States may be adopted in accordance with the
procedure referred to in Article 89(2).

1.
Detailed rules for the implementation of Articles 75(2)
and 77(2) may be adopted in accordance with the procedure
referred to in Article 89(2).

2.
Further detailed rules for the implementation of this
Directive may be adopted in accordance with the procedure
referred to in Article 89(2).

2.
Detailed rules for the control of foot-and-mouth disease
in animals referred to in Article 2(a) second sentence may be
adopted in accordance with the procedure referred to in
Article 89(2).

3.
The Annexes to this Directive may be amended in
accordance with the procedure referred to in Article 89(2) or,
in the case of Annex XI, in accordance with the procedure
referred to in Article 89(3).

3.
Immediately after the competent authority of a Member
State has information that wild animals are suspected of
being infected with foot-and-mouth disease, it shall take all
appropriate measures to confirm or rule out the presence of
the disease by investigations of all wild animals of susceptible
species shot or found dead, including laboratory testing. It
shall inform owners of animals of susceptible species and
hunters on the suspicion.

it shall

4.
As soon as the competent authority of a Member State
has confirmation of a primary case of foot-and-mouth disease
in wild animals,
immediately apply the measures
provided for in Part A of Annex XVIII in order to reduce the
spread of disease, and shall draw up a plan for the eradication
foot-and-mouth disease in accordance with Part B of
of
Annex XVIII. It shall inform owners of animals of susceptible
species and hunters of the confirmed case.

CHAPTER IV

IMPLEMENTING MEASURES

Article 86

Penalties

The Member States shall
lay down the rules on penalties
applicable to infringements of the national provisions adopted
pursuant to this Directive and shall take all measures necessary
to ensure that they are implemented. The penalties provided
for must be effective, proportionate and dissuasive. The

Article 88

Procedure for the adoption of ad hoc epidemiological
measures

Where, in implementing the measures provided for by this
Directive, a Member State determines that a measure is not
adapted to the epidemiological situation, or where the foot-
and-mouth disease virus appears to be spreading despite the
measures taken in accordance with this Directive, a Decision
may be adopted on an ad hoc basis in accordance with the
procedure referred to in Article 89(3) to authorise that Member
State to implement alternative measures with equivalent
epidemiological effect for a limited period of time appropriate
to the epidemiological situation.

Article 89

Committee procedure

1.
The Commission shall be assisted by the Standing
Committee on the Food Chain and Animal Health established
by Regulation (EC) No 178/2002.

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.

3. Where reference is made to this paragraph, Articles 5
and 7 of Decision 1999/468/EC shall apply,

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Τhe period laid down in Article 5(6) of that Decision shall be
set at 15 days.

4.

The Committee shall adopt its Rules of Procedure.

The Commission shall examine those contingency plans
against the objectives of this Directive and shall suggest to the
Member States concerned any amendments it deems necessary,
in particular to ensure that the plans are compatible with those
of the other Member States.

CHAPTER V

Those amended contingency plans shall be approved in
accordance with the procedure referred to in Article 89(2).

TRANSITIONAL AND FINAL PROVISIONS

Article 90

Amendment to Directive 92/46/EEC

In point 4(b) of Chapter I of Annex A to Council Directive 92/
46/EEC, the second subparagraph is deleted.

Article 91

Repeals

1.
Directive 85/511/EEC, without prejudice to the obli-
gations of the Member States concerning the time-limits for
transposition and application set out in Annex XIX, and
Decisions 89/531/EEC of 25 September 1989 designating a
reference laboratory for the identification of foot-and-mouth
diseasevirus and determining the functions of that labora-
tory (1) and 91/665/EEC of 11 December 1991 designating a
Community Coordinating Institute for foot-and-mouth disease
functions (2), adopted in
vaccines and laying down its
implementation thereof, are hereby repealed as from the date
referred to in Article 93.

Article 93

Transposition

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 30 June 2004 at the latest. They shall forthwith
inform the Commission thereof.

They shall apply these provisions as from 1 July 2004.

When Member States adopt those measures, they shall contain
a reference to this Directive or shall be accompanied by such a
reference on the occasion of their official publication. The
methods of making such reference shall be laid down by
Member States.

2. Member States shall communicate to the Commission
the text of the main provisions of national law which they
adopt in the field covered by this Directive.

Article 94

Entry into force

2.
References made to the repealed Directive 85/511/EEC
shall be construed as being made to this Directive and should
be read in accordance with the correlation table in Annex XX.

This Directive shall enter into force on the day of its publication
in the Official Journal of the European Union.

Article 92

Transitional provisions

Article 95

Addressees

1.
Transitional provisions may be adopted in accordance
with the procedure referred to in Article 89(2) for a period of
five years from the date of entry into force of this Directive.

This Directive is addressed to the Member States.

Done at Brussels, 29 September 2003.

2. Within six months after the date referred to in Article 94,
Member States shall submit to the Commission amended
contingency plans to take into account the provisions of
Article 72.

For the Council

G. ALEMANNO

The President

(1) OJ L 279, 28.9.1989, p. 32.
(2) OJ L 368, 31.12.1991, p. 19.

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ANNEX I

DEFINITION OF OUTBREAK

An outbreak shall be declared where a holding meets one or more of the following criteria:

1.

2.

3.

4.

Foot-and-mouth disease virus has been isolated from an animal, any product derived from that animal, or its
environment.

Clinical signs consistent with foot-and-mouth disease are observed in an animal of a susceptible species, and
the viral antigen or viral ribonucleic acid (RNA) specific to one or more of the serotypes of foot-and-mouth
disease virus has been detected and identified in samples collected from the animal or animals of the same
epidemiological group.

Clinical signs consistent with foot-and-mouth disease are observed in an animal of a susceptible species and the
animal or its cohorts are positive for antibody to foot-and-mouth disease virus structural or non-structural
proteins, provided that previous vaccination, residual maternal antibodies or non-specific reactions can be
excluded as possible causes of seropositivity.

Viral antigen or viral RNA specific to one or more of the serotypes of foot-and-mouth disease virus has been
detected and identified in samples collected from animals of susceptible species and the animals are positive for
antibody to foot-and-mouth disease virus structural or non-structural proteins, provided that in the case of
antibodies to structural proteins previous vaccination, residual maternal antibodies or non-specific reactions
can be excluded as possible causes of seropositivity.

5.

An epidemiological link has been established to a confirmed foot-and-mouth disease outbreak and at least one
of the following conditions applies:

(a)

(b)

(c)

one or more animals are positive for antibody to foot-and-mouth disease virus structural or non-structural
proteins, provided that previous vaccination, residual maternal antibodies or non-specific reactions can
be excluded as possible causes of seropositivity;

viral antigen or viral RNA specific to one or more of the serotypes of foot-and-mouth disease virus has
been detected and identified in samples collected from one or more animals of susceptible species;

serological evidence of active infection with foot-and-mouth disease by detection of seroconversion from
negative to positive for antibody to foot-and-mouth disease virus structural or non-structural proteins
has been established in one or more animals of susceptible species, and previous vaccination, residual
maternal antibodies or non-specific reactions can be excluded as possible causes of seropositivity.

Where a previously seronegative status cannot be reasonably expected, this detection of seroconversion
is to be carried out in paired samples collected from the same animals on two or more occasions at least
5 days apart, in the case of structural proteins, and at least 21 days apart, in the case of non-structural
proteins.

(d)

Clinical signs consistent with foot-and-mouth disease are observed in an animal of a susceptible species

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ANNEX II

NOTIFICATION OF DISEASE AND FURTHER EPIDEMIOLOGICAL INFORMATION TO BE PROVIDED
BY THE MEMBER STATE WHERE FOOT-AND-MOUTH DISEASE HAS BEEN CONFIRMED

1. Within 24 hours from the confirmation of each primary outbreak or case in premises or means of transport
referred to in Article 16, the Member State concerned must notify by means of the Animal Disease Notification
System established in accordance with Article 5 of Directive 82/894/EEC:

(a)

date of dispatch;

(b)

time of dispatch;

(c)

country of origin;

(d)

name of disease and type of virus, where appropriate;

(e)

serial number of outbreak;

(f)

type of outbreak;

(g)

reference number of outbreak linked to this outbreak;

(h)

region and geographical location of the holding;

(i)

(j)

other region affected by restrictions;

date of confirmation and method used for confirmation;

(k)

date of suspicion;

(l)

date of estimation of first infection;

(m) origin of disease, as far as can be indicated;

(n)

disease control measures taken.

2.

In case of primary outbreaks or cases in premises or means of transport referred to in Article 16, in addition to
the data referred to in point 1, the Member State concerned must also forward the following information:

(a)

(b)

(c)

the number of animals of each susceptible species in the outbreak, or premises and means of transport
referred to in Article 16;

for each species and type (breeding, fattening, slaughter, etc.), the number of dead animals of susceptible
species on the holding, slaughterhouse or means of transport;

for each type (breeding, fattening, slaughter, etc.), the morbidity of the disease and the number of animals
of susceptible species in which foot-and-mouth disease has been confirmed;

(d)

the number of animals of susceptible species killed in the outbreak, slaughterhouse or means of transport;

(e)

the number of carcasses processed and disposed of;

(f)

the distance of the outbreak from the nearest holding on which animals of susceptible species are kept;

(g)

if foot-and-mouth disease was confirmed in a slaughterhouse or means of transport, the location of the
holding or holdings of origin of the infected animals or carcasses.

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 Directive 82/894/EEC.

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4.

The Member State concerned shall ensure that the information to be provided in relation to any outbreak or
case of foot-and-mouth disease 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 animals of susceptible species 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 animals of susceptible species were killed;

(c) where the derogation provided for in Article 18 has been applied, the number of animals of susceptible
animals killed and processed and where applicable the number of animals of susceptible species which
are to be slaughtered at a later date and the time limit laid down for their slaughter;

(d)

(e)

(f)

any information relating to the possible origin of the disease or the origin of the disease if this has been
ascertained;

in the case of a primary outbreak or a case of foot-and-mouth disease in a slaughterhouse or means of
transport, the genetic type of virus responsible for the outbreak or the case;

in cases where animals of susceptible species have been killed in contact holdings or in holdings
containing animals of susceptible species suspected of being infected with foot-and-mouth disease virus,
information on:

(i)

(ii)

the date of killing and the number of animals of susceptible species of each category killed in each
holding and in cases where animals of susceptible species in contact holdings were not killed,
information must be provided on the reasons for this decision,

the epidemiological link between the outbreak or case of foot-and-mouth disease and each contact
holding or the reasons that have induced suspicion of foot-and-mouth disease in each suspected
holding,

(iii)

the results of the laboratory tests carried out on the samples taken from the animals of susceptible
species in the holdings and when they were killed.

5. Where the Animal Disease Notification System is for whatever reason temporarily not operational, other means

of communication shall be employed.

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ANNEX III

SURVEY

1.

Clinical examination

1.1.

1.2.

1.3.

1.4.

Holdings must undergo clinical examinations of all animals of susceptible species for signs or symptoms
of foot-and-mouth disease.

Special emphasis must be laid on animals which may have been exposed to foot-and-mouth disease
virus with a high probability, notably transport from holdings at risk or close contact to persons or
equipment that had close contact to holdings at risk.

The clinical examination must take into account the transmission of foot-and-mouth disease, including
the incubation period referred to in Article 2(h) and the way in which animals of susceptible species
are kept.

Relevant records kept on the holding must be examined in detail with particular regard to data required
for animal health purposes by Community legislation and, where available, on morbidity, mortality
and abortion, clinical observations, changes in productivity and feed intake, purchase or sale of animals,
visits of persons likely to be contaminated and other anamnestically important information.

2.

Procedures for sampling

2.1.

General provisions

2.1.1.

Serological sampling shall be carried out:

2.1.1.1.

according to the recommendations of the epidemiological team established within the expert group
referred to in Article 78, and

2.1.1.2.

in support of tracing and the provision of evidence, taking also into account the definition in Annex I,
for the absence of previous infection.

2.1.2.

2.1.3.

Where sampling is carried out in the framework of disease surveillance after an outbreak, actions shall
not commence before at least 21 days have elapsed since the elimination of susceptible animals on the
infected holding(s) and the carrying out of preliminary cleansing and disinfection, unless otherwise
provided for in this Annex.

Sampling of animals of susceptible species shall be carried out in accordance with the provisions of this
Annex in each case where sheep and goats or other susceptible animals not displaying clear clinical
signs are involved in the outbreak, and in particular where such animals have been isolated from bovine
and porcine animals.

2.2.

Sampling on holdings

In holdings where the presence of foot-and-mouth disease is suspected but in the absence of clinical
signs, sheep and goats, and on recommendation of the epidemiological team other susceptible species,
should be examined pursuant to a sampling protocol suitable to detect 5 % prevalence with at least
95 % level of confidence.

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2.3.

Sampling in protection zones

In order to seek the repeal in accordance with Article 36 of the measures provided for in Articles 21 to
35, all holdings within the perimeters of the protection zone where sheep and goats have not been in
direct and close contact with bovine animals during a period of at least 21 days prior to taking the
samples shall be examined pursuant to a sampling protocol suitable to detect 5 % prevalence of disease
with at least 95 % level of confidence.

However, the competent authorities may decide where epidemiological circumstances allow and in
particular in application of the measures provided for in Article 36(1)(b), that samples are taken not
earlier than 14 days after the elimination of susceptible animals on the infected holding(s) and the
carrying out of preliminary cleansing and disinfection, under the condition that the sampling is carried
out in accordance with point 2.3 using statistical parameters suitable to detect 2 % prevalence of disease
within the herd with at least 95 % level of confidence.

2.4.

Sampling in surveillance zones

In order to seek the repeal in accordance with Article 44 of the measures provided for in Articles 37 to
43, holdings within the perimeters of the surveillance zone where the presence of foot-and-mouth
disease in the absence of clinical signs must be suspected, notably where sheep and goats are kept, shall
be examined. For the purpose of this survey the model of a multistage sampling shall be sufficient,
provided that samples are taken:

2.4.1.

2.4.2.

2.4.3.

from holdings in all administrative units within the perimeter of the zone where sheep and goats have
not been in direct and close contact with bovine animals during a period of at least 30 days prior to
taking the samples, and

from as many holdings referred to above as necessary to detect with at least 95 % level of confidence at
least 1 infected holding if the estimated prevalence of the disease was 2 % equally distributed throughout
the zone, and

from as many sheep and goats per holding as necessary to detect 5 % prevalence of disease within the
herd with at least 95 % level of confidence, and from all sheep and goats if there are less than 15 sheep
and goats on the holding.

2.5.

Sampling for monitoring

2.5.1.

For monitoring the areas outside the zones established in accordance with the provisions of Article 21,
and in particular to substantiate the absence of infection in the sheep and goat population which is not
in close and direct contact with non-vaccinated bovine or porcine animals, a sampling protocol
recommended for monitoring purposes by the OIE or a sampling protocol as provided for in
paragraph 2.4 shall be applied with the difference compared to paragraph 2.4.2 that the estimated herd
prevalence shall be set at 1 %.

3.

The number of samples calculated in accordance with requirements in paragraphs 2.2, 2.3 and 2.4.3
shall be increased in order to take into account the established diagnostic sensitivity of the test
employed.

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ANNEX IV

PRINCIPLES AND PROCEDURES FOR CLEANSING AND DISINFECTION

1.

1.1.

1.2.

1.3.

1.4.

1.5.

General principles and procedures

Cleansing and disinfection operations as provided for in Article 11 shall be carried out under official
supervision and in accordance with the instructions given by the official veterinarian.

The disinfectants to be used and their concentrations shall be officially recognised by the competent
authority to ensure destruction of foot-and-mouth virus.

The activity of disinfectants must not be impaired by prolonged storage.

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.

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 must be observed. The activity of the disinfectant
must not be compromised by interaction with other substances, such as degreasing agents.

1.6.

Independently of the disinfectant used, the following general rules shall apply:

1.6.1.

thorough soaking of bedding and litter as well as faecal matter with the disinfectant,

1.6.2.

1.6.3.

1.6.4.

1.7.

1.8.

1.9.

washing and cleaning by careful brushing and scrubbing of all surfaces possibly contaminated and in
particular 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,

then further application of disinfectant for a minimum contact time as stipulated in the manufacturers
recommendations;

the water used for cleaning operations is to be disposed of in such a way as to avoid any risk of
spreading the foot-and-mouth disease virus and in accordance with the instructions of the official
veterinarian.

Where washing is carried out with liquids applied under pressure and following the disinfection, re-
contamination of the previously cleansed or disinfected parts must be avoided.

Washing, disinfecting or destroying of equipment, installations, articles or compartments likely to be
contaminated should be included.

Cleansing and disinfection operations required in the framework of this Directive must be documented
in the holding register or, in the case of vehicles, in the log-book and where official approval is required
be certified by the supervising official veterinarian.

2.

Special provisions on cleansing and disinfection of infected holdings

2.1.

Preliminary cleansing and disinfection

2.1.1.

During the killing of the animals all necessary measures shall be taken to avoid or minimise the
dispersion of foot-and-mouth virus. This shall include among other things 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.

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2.1.2.

2.1.3.

2.1.4.

Carcasses of killed animals must be sprayed with disinfectant and removed from the holding in covered
and leak-proof containers for processing and disposal.

As soon as the carcasses of the animals of susceptible species have been removed for processing and
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 this purpose.

Any tissue or blood which may have been spilled during slaughter or post-mortem examination and
any gross contamination of buildings, yards, utensils, etc. should be carefully collected and disposed of
with the carcasses.

2.1.5.

The used disinfectant shall remain on the surface for at least 24 hours.

2.2.

Final cleansing and disinfection

2.2.1.

Grease and dirt should be removed from all surfaces by the application of a degreasing agent and
washed with cold water.

2.2.2.

After washing with cold water further spraying with disinfectant should be applied.

2.2.3.

After seven days the premises should be treated again with a degreasing agent, rinsed with cold water,
sprayed with disinfectant and rinsed again with cold water.

3.

3.1.

3.2.

4.

4.1.

4.2.

4.3.

Disinfection of contaminated bedding, manure and slurry

The solid phase of manure and used bedding should be stacked to heat, preferably by adding 100 kg
granulated quick lime on 1 m3 manure, ensuring a temperature of at least 70 °C throughout the stack,
sprayed with disinfectant and left for at least 42 days, during which the stack should be either covered
or re-stacked to ensure thermic treatment of all layers.

The liquid phase of manure and slurry should be stored for at least 42 days after the last addition of
infective material. This period may be extended if the slurry has been heavily contaminated or during
adverse weather conditions. This period may be shortened if disinfectant has been added so as to alter
the pH sufficiently throughout the substance to destroy the foot-and-mouth disease virus.

Special cases

Where for technical or security reasons the cleansing and disinfection procedures cannot be completed
in accordance with this Directive, the buildings or premises must be cleansed and disinfected as much
as possible to avoid spread of the foot-and-mouth disease virus and must remain unoccupied by
animals of susceptible species for at least 1 year.

By way of derogation from points 2.1 and 2.2, 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.

By way of derogation from point 3, the competent authority may establish specific procedures for the
disinfection of dung and manure in accordance with scientific evidence that the procedure ensure
effective destruction of the foot-and-mouth disease virus.

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ANNEX V

RESTOCKING OF HOLDINGS

1.

General principles

1.1.

Restocking should not commence until 21 days after completion of the final disinfection of the holding.

1.2.

Animals for restocking can only be introduced under the following conditions:

1.2.1.

1.2.2.

the animals shall not come from areas subject to animal health restrictions in relation to foot-and-
mouth disease;

the competent authorities must be satisfied that any possible residual foot-and-mouth disease virus can
be detected in the animals intended for restocking either on the base of clinical signs, in the case of
bovine or porcine animals, or though laboratory investigations in the case of other species susceptible
to foot-and-mouth disease, carried out at the end of the observation period specified in paragraph 1.3;

1.2.3.

in order to ensure an adequate immune response referred to in paragraph 1.2.2 in the animals intend
for restocking, the animals must:

1.2.3.1.

either originate in and come from a holding situated in an area of at least 10 km radius centred on that
holding where there was no outbreak of foot-and-mouth disease for at least 30 days, or

1.2.3.2.

the animals have been tested with negative results in an assay as described in Annex XIII for the
detection of antibodies against the foot-and-mouth disease virus carried out on samples taken prior to
introduction onto the holding.

1.3.

Irrespective of the type of farming practised on the holding, re-introduction must conform with the following
procedures:

1.3.1.

animals must be introduced in all units and buildings of the holding involved;

1.3.2.

in the case of a holding consisting of more than one unit or building, re-introduction is not necessary
for every unit or building at the same time;

However no animals of species susceptible to foot-and-mouth disease may leave the holding until all
the re-introduced animals in all units and buildings have fulfilled all restocking procedures.

animals must be subjected to clinical inspection every three days for the first 14 days following the
introduction;

during the period from 15 to 28 days after re-introduction, animals are to be subjected to clinical
inspection once every week;

not earlier than 28 days after the last re-introduction, all animals must be clinically examined and
samples for testing for the presence of antibody against foot-and-mouth disease virus shall be taken in
accordance with the requirements of point 2.2 of Annex III;

1.3.3.

1.3.4.

1.3.5.

1.4.

The restocking procedure shall be considered completed when the measures provided for in point 1.3.5
have been completed with negative results.

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2.

Extension of measures and derogations

2.1.

The competent authority may impose:

2.1.1.

the use of sentinel animals, in particular in holdings difficult to clean and disinfect and notably open-
air holdings. Detailed provision on the use of sentinels may be laid down in accordance with the
procedure referred to in Article 89(2).

2.1.2.

Additional safeguard and control measures within the framework of restocking.

2.2.

3.

3.1.

3.2.

3.2.1.

The competent authorities may derogate from the measures provided for in points 1.3.2 to 1.3.4 of
this Annex where restocking is carried out after 3 months have elapsed following the last outbreak in
an area of 10 km radius centred on the holding subject to the restocking operation.

Restocking in connection with emergency vaccination

Restocking in a vaccination zone established in accordance with Article 52 shall be carried out either
in accordance with paragraphs 1 and 2 of this Annex or in accordance with Article 58(2) or (4)(a), (c)
and (d).

The competent authorities may authorise the restocking of holdings situated outside the vaccination zone with
vaccinated animals after the completion of the measures provided for in Article 61 and under the following
conditions:

the proportion of vaccinated animals used for restocking exceeds 75 % in which case, not earlier than
28 days after the last re-introduction of animals of susceptible species, the vaccinated animals are tested
for the detection of antibodies against non-structural proteins, randomly, the sampling using the
statistical parameters provided for in point 2.2 of Annex III and for the non-vaccinated animals the
provisions of paragraph 1 shall apply, or

3.2.2.

The proportion of vaccinated animals does not exceed 75 % in which case the non-vaccinated animals
shall be considered sentinels and provisions of paragraph 1 shall apply.

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ANNEX VI

RESTRICTIONS ON THE MOVEMENT OF EQUIDAE

1.

Minimum measures

Where at least one outbreak of foot-and-mouth disease has been confirmed in accordance with
Article 10, Member States shall ensure that equidae are not dispatched to other Member States, unless
accompanied in addition to the identification document provided for in Decisions 93/623/EEC or
2000/68/EC by an animal health certificate provided for in Annex C of Directive 90/426/EEC.

2.

Recommended additional measures

2.1.

Measures during the stand-still

In the case where the competent authorities apply a complete stand-still as provided for in Article 7(3),
transport of equidae from holdings under restrictions laid down in Articles 4 and 10 may be authorised
for equidae which need special veterinary treatment in premises without animals of susceptible species,
if the following conditions are met:

2.1.1.

the emergency must be documented by the veterinary surgeon on call 24 hours per day, 7 days per
week;

2.1.2.

the agreement of the clinic of destination must be producible;

2.1.3.

2.1.4.

the transport operation must be authorised by the competent authorities who must be reachable
24 hours per day, 7 days per week;

equidae must be accompanied during the transport by an identification document in accordance with
Decisions 93/623/EEC or 2000/68/EC;

2.1.5.

the on-call official veterinarian must be informed about the route prior to departure;

2.1.6.

equidae must be groomed and treated with an effective disinfectant;

2.1.7.

equidae must travel in dedicated equine transport which is recognisable as such and cleansed and
disinfected prior to and after use.

2.2.

Controls on equidae in relation to protection and surveillance zones

2.2.1.

2.2.2.

2.2.2.1.

Movement of equidae outside the protection and surveillance zones is not subject to conditions in
excess of those resulting from Directive 90/426/EEC.

Movement of equidae within the protection and surveillance zones established in accordance with
Article 21 is subject to the following conditions:

the use of equidae kept on holdings in the protection and surveillance zone not keeping animals of
susceptible animals may be authorised in the protection zone, subject to appropriate cleansing and
disinfection measures, and may not be restricted on premises situated in the surveillance zone;

2.2.2.2.

equidae may be transported without restrictions in dedicated equine transport to a holding not keeping
animals of susceptible species;

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2.2.2.3.

the competent authorities may in exceptional cases authorise the transport of equidae in dedicated or
registered equine transport from a holding not keeping animals of susceptible species to another
holding keeping animals of susceptible species situated in the protection zone, subject to cleansing and
disinfection of the transport prior to loading of the animals and before leaving the holding of
destination;

2.2.2.4.

movement of equidae may be allowed on public roads, on pastures belonging to holdings not keeping
animals of susceptible species and exercise premises.

2.2.3.

2.2.4.

The collection of equine semen, ova and embryos from donor animals on holdings not keeping animals
of susceptible species in the protection and surveillance zone and the transport of equine semen, ova
and embryos to recipient equine animals on holdings not keeping animals of susceptible species shall
not be restricted.

Visits from owners of equidae, the veterinary surgeon, the inseminator and the farrier on holdings
keeping animals of susceptible species in the surveillance zones but not subject to the restrictions
provided for in Articles 4 and 10 shall be subject to the following conditions:

2.2.4.1.

equidae are kept separated from animals of susceptible species and access of the persons referred to
above to animals of susceptible species is effectively prevented;

2.2.4.2.

all visitors must be registered;

2.2.4.3.

cleansing and disinfecting of means of transportation and of the boots of visitors.

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TREATMENT OF PRODUCTS TO ENSURE THE DESTRUCTION OF FOOT-AND-MOUTH DISEASE VIRUS

ANNEX VII

PART A

Products of animal origin

1. Meat products that have undergone at least one of the treatments provided for in the first column in Table 1 of

Annex III of Directive 2002/99/EC.

2.

3.

Hides and skins complying with the requirements in Article 20 and points A(2)(c) or (d) of Chapter VI of
Annex VIII to Regulation (EC) No 1774/2002.

Sheep wool, ruminant hair and pig bristles complying with the requirements in Article 20 and point A(1) of
Chapter VI of Annex VIII to Regulation (EC) No 1774/2002.

4.

Products derived from animals of susceptible species which have undergone:

(a)

either a heat treatment in a hermetically sealed container with an Fo value of 3,00 or more; or

(b)

a heat treatment in which the centre temperature is raised to at least 70 °C for at least 60 minutes.

5.

6.

7.

8.

9.

including
Blood and blood products of animals of susceptible species used for technical purposes,
pharmaceuticals, in vitro diagnostics and laboratory reagents which have undergone at least one of the
treatments referred to in point B(3) (e) (ii) of Chapter IV of Annex VIII to Regulation (EC) No 1774/2002.

Lard and rendered fats which have undergone the heat treatment referred to in point B(2) (d) (iv) of Chapter IV
of Annex VII to Regulation (EC) No 1774/2002.

Petfood and dogchews which comply with the requirements of points B(2), (3) or (4) of Chapter II of Annex VIII
to Regulation (EC) No 1774/2002.

Game trophies of ungulates which comply with the requirements of points A(1), (3) or (4) of Chapter VII of
Annex VIII to Regulation (EC) No 1774/2002.

Animal casings which in accordance with Chapter 2 of Annex I to Directive 92/118/EEC have been cleaned,
scraped and either salted with sodium-chloride for 30 days or bleached or dried after scraping and were
protected from re-contamination after treatment.

PART B

Products not of animal origin

1.

Straw and forage which

(a)

either has undergone the action of

(i)

(ii)

steam in a closed chamber for at least 10 minutes and at a minimum temperature of 80 °C, or

formalin fumes (formaldehyde gas) produced in a chamber kept closed for at least 8 hours and at a
minimum temperature of 19 °C, using commercial-type solutions at 35-40 % concentration, or

(b)

has been stored in package or bales under shelter at premises situated not closer than 2 km to the nearest
outbreak of foot-and-mouth disease and is not released from the premises before at least three months
have elapsed following the completion of cleansing and disinfection measures provided for in Article 11
and in any case not before the end of the restrictions in the protection zone.

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ANNEX VIII

PART A

Treatment of fresh meat

1.

De-boned fresh meat:

Meat as described in Article 2(a) of Directive 64/433/EEC together with diaphragms but excluding offal, from
which the bone and the main accessible lymphatic glands have been removed.

2.

Trimmed offal:

— heart from which lymphatic glands, connective tissue and adhering fat have been completely removed;

— liver from which lymphatic glands, adhering connective tissue and fat have been completely removed;

— whole masseter muscles,

incised in accordance with paragraph 41(a) of Chapter VIII of Annex I to
Directive 64/433/EEC, from which lymphatic glands, connective tissue and adhering fat have been
completely removed;

— tongues with epithelium and without bone, cartilage and tonsils;

— lungs from which the trachea and main bronchi and the mediastinal and bronchial lymphatic glands have

been removed;

— other offal without bone or cartilage from which lymphatic glands, connective tissue, adhering fat and

mucous membrane have been completely removed.

3. Maturation:

— maturation of carcasses at a temperature of more than + 2 °C for at least 24 hours;

— pH value in the middle of Longissimus dorsi muscle recorded as less than 6,0.

4.

Effective measures must be applied to avoid cross-contamination.

PART B

Additional measures applicable to the production of fresh meat from animals of susceptible species
originating in the surveillance zone

1.

Fresh meat, excluding heads, viscera and offals, intended for placing on the market outside the protection and
surveillance zone shall be produced according to at least one of the following additional conditions:

(a)

in the case of ruminants:

(i)

the animals have been subjected to the controls provided for in Article 24(2), and

(ii)

the meat is subject to the treatment provided for in points 1, 3 and 4 of Part A;

(b)

in the case of all animals of susceptible species:

(i)

the animals have been resident on the holding for at least 21 days and are identified so as to allow
the tracing of the holding of origin, and

(ii)

the animals have been subjected to the controls provided for in Article 24(2), and

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(iii)

the meat is clearly identified and detained under official supervision for at least 7 days and is not
released until any suspicion of infection with the foot-and-mouth disease virus on the holding of
origin has been officially ruled out at the end of the detention period;

(c)

in the case of all animals of susceptible species:

(i)

(ii)

(iii)

(iv)

the animals have completed a 21-day standstill on the holding of origin during which no animal of
a species susceptible to foot-and-mouth disease has been introduced onto the holding, and

the animals have been subjected to the controls provided for in Article 24(2) within 24 hours of
loading, and

samples taken in accordance with the statistical requirements provided for in point 2.2 of Annex III
within 48 hours of loading have been tested with negative result in an assay for the detection of
antibodies against the foot-and-mouth disease virus, and

the meat is detained under official control for 24 hours and not released before a repeat inspection
of the animals in the holding of origin has ruled out on clinical inspection the presence of infected
or suspected of being infected animals.

2.

Trimmed offal shall be marked with the health mark provided for in Directive 2002/99/EC and shall be subject
to one of the treatments provided for in point 1 in Part A of Annex VII of this Directive.

3.

Other products shall be subjected to the treatment provided for in Article 32.

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ANNEX IX

TREATMENT OF MILK TO ENSURE DESTRUCTION OF FOOT-AND-MOUTH VIRUS

PART A

Milk and milk products intended for human consumption

The following treatments are recognised to provide sufficient guaranties with regard to the destruction of the foot-
and-mouth disease virus in milk and milk products for human consumption. Necessary precautions must be taken
to avoid contact of the milk or milk products with any potential source of foot-and-mouth virus after processing.

1.

Milk intended for human consumption must be subject to at least one of the following treatments:

1.1.

sterilisation at a level of at least F03;

1.2.

UHT (1) treatment;

1.3.

HTST (2) treatment applied twice to milk with a pH equal to or above 7,0;

1.4.

HTST treatment of milk with a pH below 7,0;

1.5.

HTST combined with another physical treatment by:

1.5.1.

either lowering the pH below 6 for at least one hour, or

1.5.2.

additional heating to 72 °C or more, combined with desiccation.

2.

3.

Milk products must either undergo one of the above treatments or be produced from milk treated in
accordance with paragraph 1.

Any other treatment shall be decided in accordance with the procedure referred to in Article 89(2), in
particular in relation to raw milk products undergoing an extended period of ripening including a lowering
of the pH below 6.

PART B

Milk and milk products not intended for human consumption and milk and milk products for animal
consumption

The following treatments are recognised to provide sufficient guaranties with regard to the destruction of the foot-
and-mouth disease virus in milk and milk products not intended for human consumption or intended for animal
consumption. Necessary precautions must be taken to avoid contact of the milk or milk products with any potential
source of foot-and-mouth virus after processing.

1.

Milk not intended for human consumption and milk intended for animal consumption must be subject to
at least one of the following treatments:

1.1.

sterilisation at a level of at least F03;

(1) UHT = Ultra-High Temperature treatment at 132 °C for at least one second.
(2) HTST = High Temperature Short Time pasteurisation at 72 °C for at least 15 seconds or equivalent pasteurisation effect

achieving a negative reaction to a phosphatase test.

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1.2.

1.3.

1.4.

UHT (1) combined with another physical treatment referred to in either paragraph 1.4.1 or 1.4.2;

HTST (2) applied twice;

HTST combined with another physical treatment by:

1.4.1.

either lowering the pH below 6 for at least one hour, or

1.4.2.

additional heating to 72 °C or more, combined with desiccation.

2.

3.

Milk products must either undergo one of the above treatments or be produced from milk treated in
accordance with paragraph 1.

Whey to be fed to animals of susceptible species and produced from milk treated as described in
paragraph 1 must be collected at least 16 hours after milk clotting and its pH must be recorded as <6.0
before transport to pig holdings.

(1) UHT = Ultra High Temperature treatment at 132 °C for at least one second.
(2) HTST = High Temperature Short Time pasteurisation at 72 °C for at least 15 seconds or equivalent pasteurisation effect

achieving a negative reaction to a phosphatase test.

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ANNEX X

CRITERIA FOR THE DECISION TO APPLY PROTECTIVE VACCINATION AND GUIDELINES FOR THE
EMERGENCY VACCINATION PROGRAMMES

1.

Criteria for the decision to apply protective vaccination (*)

Criteria

Decision

For vaccination

Against vaccination

Population density of susceptible animals

Predominant species clinically affected

High

pigs

Movement of potentially infected animals or products
out of the protection zone

Evidence

Predicted airborne spread of virus from infected High
holdings

Low

ruminants

No evidence

Low or absent

Suitable vaccine

Available

Not available

Origin of outbreaks (traceability)

Unknown

Known

Incidence slope of outbreaks

Rising rapidly

Shallow or slow rise

Distribution of outbreaks

Widespread

Restricted

Public reaction to total stamping out policy

Strong

Acceptance of regionalisation after vaccination

Yes

Weak

No

2.

Additional criteria for the decision to introduce emergency vaccination

Criteria

Decision

For vaccination

Against vaccination

Acceptance of regionalisation by third coun-
tries

known

unknown

Economic assessment of competing control
strategies

is foreseeable that a
strategy without

If
it
If it is foreseeable that a con-
control
trol strategy with emergency
vaccination vaccination would lead to sig-
emergency
would lead to significantly nificantly higher economic
higher economic losses in losses in the agricultural and
the agricultural and non- non-agricultural sectors
agricultural sectors

(*) in accordance with the report of the Scientific Committee on Animal Health 1999

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Criteria

Decision

For vaccination

Against vaccination

It is foreseeable that
cannot be implemented effectively for two
consecutive days (1)

the 24/48 hours rule Yes

Significant social and psychological impact of Yes
total stamping out policy

Existence of large holdings of intensive live- Yes
stock production in a non-densely populated
livestock area

No

No

No

(1) 24/48 hours rule means:

(a)

infected herds on holdings referred to in Article 10 cannot be stamped out within 24 hours after the confirmation
of the disease, and

(b) the pre-emptive killing of animals likely to be infected or contaminated cannot be safely carried out within less than

48 hours.

3.

Definition of Densely Populated Livestock Areas (DPLAs)

3.1. When deciding about the measures to be taken in application of this Directive, and in particular the measures
provided for in Article 52(2), Member States shall in addition to a thorough epidemiological assessment
consider the definitions of DPLAs as provided for in point 3.2. or where applicable as provided for in
Article 2(u) of Directive 2001/89/EC and use the definition which is the more stringent.

The definition may be modified in the light of new scientific evidence in accordance with the procedure
referred to in Article 89(2).

3.2. Animals of susceptible species

In the case of animals of susceptible species a DPLA shall be a geographical area, with a radius of 10 km
around a holding containing animals of susceptible species suspected of or infected with foot-and-mouth
disease, where there is a density of animals of susceptible species higher than 1 000 head per km2. The holding
in question must be situated either in a sub-region as defined in Article 2(s) where there is a density of animals
of susceptible species higher than 450 head per km2 or at a distance of less than 20 km from such a sub-
region.

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ANNEX XI

PART A

National laboratories authorised to handle live foot-and-mouth disease virus

Member State where
Laboratory is situated

Laboratory

Member States using the
services of laboratory

Belgium

Denmark

Veterinary and Agrochemical Research Centre CODA-
CERVA-VAR, Uccle

Belgium
Luxembourg

Danish Veterinary Institute, Department of Virology, Lind- Denmark
holm

Finland
Sweden

Germany

Bundesforschungsanstalt der Tiere für Viruskrankheiten,

Germany

— Anstalsteil Tübingen

— Anstaltsteil Friedrich-Loeffler-Institut, Insel Riems

Greece

Ινστιτούτο αφθώδους πυρετού, Αγία Παρασκευή Αττικής

Greece

Spain

France

Laboratorio Central de Veterinaria Algete, Madrid

Spain

Agence française de sécurité sanitaire des aliments (AFSSA)

France

— Laboratoire d’études et de recherches en pathologie

bovine et hygiène des viandes, Lyon

— Laboratoire d’études et de recherches en pathologie

animale et zoonoses, Maison-Alfort

Italy

Istituto zooprofilattico sperimentale della Lombardia e
dell’Emilia Romagna, Brescia

Italy

Netherlands

CIDC-Lelystad, Central Institute for Animal Disease Con- Netherlands
trol, Lelystad

Austria

Österreichische Agentur für Gesundheit und Ernährungs- Austria
sicherheit
Veterinärmedizinische Untersuchungen Mödling

United Kingdom

Institute for Animal Health, Pirbright

United Kingdom
Ireland
Sweden
Finland

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Laboratories authorised to handle live foot-and-mouth virus for vaccine production

PART B

Member state

Manufacturer

Germany

France

Bayer AG, Köln

Merial, S.A.S., Laboratoire IFFA, Lyon

Netherlands

CIDC-Lelystad, Central Institute for Animal Disease Control, Lelystad

United Kingdom

Merial, S.A.S., Pirbright Laboratory, Pirbright

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ANNEX XII

BIOSECURITY STANDARDS FOR LABORATORIES AND ESTABLISHMENTS HANDLING LIVE
FOOT-AND-MOUTH DISEASE VIRUS

1.

2.

The laboratories and establishments handling live foot-and-mouth disease virus must meet or exceed the
minimum requirements laid down in the ‘Minimum standards for Laboratories working with foot-and-mouth
virus in vitro and in vivo’ established by the European Commission for the control of foot-and-mouth disease,
26th session, Rome, April 1985, as modified in 1993.

The laboratories and establishments handling live foot-and-mouth disease virus must be subject to at least two
inspections within five years, with one of the inspections being carried out unannounced.

3.

The inspection team shall comprise at least of

— one expert from the Commission,

— one expert in foot-and-mouth disease,

— one independent expert for questions of bio-security in laboratories working with microbiological

hazards.

4.

The inspection team shall submit a report to the Commission and the Member States in accordance with
Decision 98/139/EC.

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ANNEX XIII

DIAGNOSTIC TESTS AND STANDARDS FOR FOOT-AND-MOUTH DISEASE AND FOR THE DIFFEREN-
TIAL DIAGNOSIS OF OTHER VESICULAR VIRUS DISEASES

In the context of this Annex, a ‘test’ refers to a laboratory diagnostic procedure and a ‘standard’ to a reference reagent
that has become an internationally accepted standard following a procedure of comparative testing carried out in
several different laboratories.

PART A

Diagnostic tests

1.

Recommended procedures

Diagnostic tests described in the OIE Manual, hereinafter the ‘OIE Manual’, as the ‘Prescribed Tests’ for
international trade, constitute the reference tests for vesicular disease diagnosis within the Community.
National Laboratories must adopt standards and tests at least as stringent as those defined in the OIE
Manual.

The Commission may, in accordance with the procedure referred to in Article 89(2) decide to adopt more
stringent testing procedures than those defined in the OIE Manual.

2.

Alternative procedures

The use of tests defined in the OIE Manual as ‘Alternative Tests’, or other tests not included in the OIE
Manual, is permitted provided that the performance of the test has been shown to match or exceed the
sensitivity and specificity parameters laid down in the OIE Manual or in the annexes to Community
legislation, whichever is the more stringent.

National Laboratories generating results for the purposes of national, intra-Community or international
trade must generate and store the necessary records demonstrating compliance of their testing procedures
with the relevant OIE or Community requirements.

3.

Standards and quality control

National Laboratories shall participate in periodic standardisation and external quality assurance exercises
organised by the Community Reference Laboratory.

In the framework of such exercises, the Community Reference Laboratory may take account of the results
achieved by a National Laboratory which has within a reasonable timespan participated in a quality
assurance exercise organised by one of the international organisations responsible for external quality
assurance of vesicular virus disease diagnosis, such as OIE, the Food and Agriculture Organisation (FAO)
of the United Nations or the International Atomic Energy Agency.

National Laboratories shall operate internal quality assurance programmes. The specification of such
programmes may be laid down in accordance with the procedure referred to in Article 89(2). Pending the
adoption of detailed provisions, the specifications in the OIE Guidelines for Laboratory Quality Evaluation
shall apply (OIE Standards Commission, September 1995).

As part of quality assurance, National Laboratories shall demonstrate compliance of the tests in routine
use with the requirements for sensitivity and specificity defined in the OIE Manual, or in Annexe XIV of
this Directive, whichever is more stringent.

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4.

Procedures for adoption and review of tests and standards for vesicular virus disease diagnosis.

Tests and standards for vesicular virus disease diagnosis shall be adopted in accordance with the procedure
referred to in Article 89(2).

The Commission may consider the scientific advice produced by the meetings of the National Laboratories
to be organised by the Community Reference Laboratory.

5.

Compliance procedure

Data from standardisation and external quality assurance exercises organised by the Community Reference
Laboratory shall be assessed at the annual meetings of the National Laboratories and communicated to the
Commission for review of the list of National Laboratories as laid down in Part A of Annex XI.

Those laboratories whose tests do not meet the prescribed requirements for sensitivity and specificity shall
be required by the Commission to adapt their procedures within an appropriate period of time to ensure
that these requirements are met. Failure to demonstrate the required level of proficiency within the time
limit required shall result in loss of recognition within the Community of all testing performed after that
deadline.

6.

Selection and transportation of samples

An aliquot of field material should be sent to one of the laboratories listed in Part A of Annex XI. However,
where such samples are not available or not suitable for transport, animal passage material, obtained from
the same host species, or low passage cell culture material is acceptable.

The history of animal or cell passage material should be provided.

Samples for vesicular virus diagnosis can be transported at 4 °C if the anticipated transport time to the
recipient laboratory is less than 24 hours.

For oesophageal-pharyngeal (probang) samples, transportation above solid carbon dioxide or liquid
nitrogen is recommended, especially if delays at airports cannot be excluded.

Special precautions are required for the safe packaging of material from suspect cases of foot-and-mouth
disease both within and between countries. These regulations are mainly designed to prevent breakage or
leakage of containers and the risk of contamination, but are also important to ensure that specimens arrive
in a satisfactory state. Ice-packs are preferred to wet ice to prevent the possibility of escape of water from
the package.

Prior notice of arrival, and agreement for receipt, must be arranged with the receiving laboratory before
despatch of samples.

Compliance with the import and export regulations of the Member States involved must be ensured.

PART B

Standards

The protocols specified in the OIE Manual provide reference procedures for virus isolation, antigen detection and
antibody detection for vesicular diseases.

1.

Foot-and-mouth disease

1.1.

A n t i g e n d e t e c t i o n

The standards for detecting foot-and-mouth disease virus antigen shall be established in accordance with
the procedure referred to in Article 89(2) after consultation of the Community Reference Laboratory.

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Standardised, inactivated antigens of all seven serotypes are available from the OIE/FAO World Reference
Laboratory for foot-and-mouth disease (WRL).

National Laboratories should ensure that their antigen detection system complies with these minimum
standards. They shall where necessary receive advice from the Community Reference Laboratory on the
dilutions of these antigens to be used as strong and weak positive controls.

1.2.

V i r u s i s o l a t i o n

The standards for foot-and-mouth disease virus detection shall be established in accordance with the
procedure referred to in Article 89(2) after consultation of the Community Reference Laboratory.

Isolates of foot-and-mouth disease virus are available from the WRL.

National Laboratories shall ensure that the tissue culture systems in use for foot-and-mouth virus isolation
are sensitive to the full range of serotypes and strains for which the laboratory maintains a diagnostic
capacity.

1.3.

N u c l e i c a c i d d e t e c t i o n m e t h o d s

The standards for the detection of foot-and-mouth disease viral RNA shall be established in accordance
with the procedure referred to in Article 89(2) after consultation of the Community Reference Laboratory.

The Commission may arrange that for future standardisation, comparative testing of the sensitivity of RNA
detection methods is carried out between National Laboratories.

The Commission may arrange that, taking into account the practical difficulties of storing nucleic acids for
prolonged periods of time, standardised quality assurance reagents for the detection of foot-and-mouth
viral RNA will become available from the Community Reference Laboratory.

1.4.

A n t i b o d y d e t e c t i o n ( s t r u c t u r a l p r o t e i n s )

The standards for the detection of antibody to foot-and-mouth disease virus shall be established in
accordance with the procedure referred to in Article 89(2) after consultation of the Community Reference
Laboratory.

Standardised antisera for foot-and-mouth disease virus types O1-Manisa, A22-Iraq and C-Noville have
been defined by the ‘FAO Phase XV Standardisation Exercise in foot-and-mouth disease antibody detection’
in 1998.

The Commission may arrange that standardised reference sera for all the main antigenic variants of foot-
and-mouth disease virus are adopted as a result of standardisation exercises between the Community
Reference Laboratory and the National Laboratories. These reference sera will be adopted as the standards
for use by National Laboratories within the Community.

1.5.

A n t i b o d y d e t e c t i o n ( n o n - s t r u c t u r a l p r o t e i n s )

The standards for the detection of antibody to foot-and-mouth disease virus shall be established in
accordance with the procedure referred to in Article 89(2) after consultation of the Community Reference
Laboratory.

The Commission may arrange that standardised reference sera are adopted as a result of standardisation
exercises between the Community Reference Laboratory and the National Laboratories. These reference
sera will be adopted as the standards for use by National Laboratories within the Community.

2.

Swine vesicular disease (SVD)

Diagnosis of SVD must be carried out in accordance with Decision 2000/428/EC.

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3.

Other vesicular diseases

Where necessary, the Commission may arrange that standards for the laboratory diagnosis of vesicular
stomatitis or vesicular exanthema of swine are established in accordance with the procedure referred to in
Article 89(2).

Member States may maintain the laboratory capacity to diagnose the vesicular virus diseases other than
foot-and-mouth disease and SVD, i.e. vesicular stomatitis and vesicular exanthema of swine.

National Laboratories wishing to maintain a diagnostic capacity for these viruses can obtain reference
reagents from the WRL, Pirbright or from the relevant OIE Reference Laboratory.

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ANNEX XIV

COMMUNITY ANTIGEN AND VACCINE BANK

1.

Conditions for the supply and storage of the concentrated inactivated antigen supplied to the Community
antigen and vaccine bank:

(a)

(b)

(c)

(d)

(e)

each antigen consists of a single homogeneous batch;

each batch is split in order to permit it to be stored at two separate geographical sites under the
responsibility of the designated premises of the Community antigen and vaccine bank;

the antigen meets at least the requirements of the European Pharmacopoeia and the relevant provisions
of the OIE Manual;

the principles of Good Manufacturing Practise are maintained throughout the production process and
this shall include the storage and finishing of the vaccine reconstituted from the antigens in store;

if not otherwise specified in the texts referred to in point (c), the antigen is purified to remove non-
structural proteins of the foot-and-mouth disease virus. The purification shall at least ensure that the
residual content of non-structural proteins in vaccines reconstituted from such antigen does not induce
detectable levels of antibody against non-structural proteins in animals which had received one initial and
one subsequent booster vaccination.

2.

Conditions for the formulation, finishing, bottling,
concentrated inactivated antigen supplied to the Community antigen and vaccine bank:

labelling and delivery of vaccines reconstituted from

(a)

(b)

rapid formulation into vaccine of the antigen referred to in Article 81;

production of a safe, sterile and efficient vaccine with a potency of at least 6 PD50 in accordance with the
tests prescribed by the European Pharmacopoeia, and suitable for use in case of emergency vaccination of
ruminants and pigs;

(c)

a capacity to formulate from concentrated inactivated antigen in stock:

(i)

up to one million doses of vaccine within four days of instruction from the Commission;

(ii)

additionally, up to four million doses of vaccine within 10 days of instruction from the Commission;

(d)

rapid bottling, labelling and distribution of the vaccine according to the specific needs of the area where
vaccination is to be carried out.

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ANNEX XV

FUNCTIONS AND DUTIES OF NATIONAL LABORATORIES

The functions and duties of National Laboratories referred to in Article 68 for foot-and-mouth and other vesicular
diseases shall be as follows:

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

All National Laboratories handling live foot-and-mouth disease virus must operate under high security
conditions laid down in ‘Minimum Standards for Laboratories working with foot-and-mouth disease virus
in vitro and in vivo’, European Commission for the Control of Foot-and-Mouth Disease — 26th Session,
Rome, 1985, as amended by Appendix 6 (ii) of the Report of the 30th Session, Rome, 1993.

National Laboratories must provide an uninterrupted service for diagnosing vesicular viral diseases and
must be equipped and skilled for providing a rapid initial diagnosis.

National Laboratories must keep inactivated reference strains of all serotypes of foot-and-mouth disease
virus, and immune sera against the viruses, as well as all other reagents necessary for a rapid diagnosis.
Appropriate cell cultures should be in constant readiness for confirming a negative diagnosis.

National Laboratories must be equipped and skilled for large-scale serological surveillance.

In all suspected primary outbreaks appropriate samples must be collected and quickly transported,
according to a set protocol, to a National Laboratory. In anticipation of a suspicion of foot-and-mouth
disease, the National Authority shall ensure that the necessary equipment and materials for sample
collection and transportation to a National Laboratory are stored in readiness at local sites.

Antigenic typing and genomic characterisation must be carried out on all viruses responsible for new
incursions into the Community. This can be performed by the National Laboratory, if facilities exist.
Otherwise, at the earliest possible occasion, the National Laboratory must send a sample of virus from the
primary case to the Community Reference Laboratory for confirmation and further characterisation,
including advice on the antigenic relationship of the field strain to vaccine strains in the Community
antigen and vaccine banks. The same procedure should be followed for viruses received by National
Laboratories from third countries in situations where characterisation of the virus is likely to be of benefit
to the Community.

National Laboratories should provide disease data to their State Veterinary Service, which shall provide
these data to the Community Reference Laboratory.

National Laboratories should collaborate with the Community Reference Laboratory in ensuring that
members of the field section of State Veterinary Services have the opportunity of seeing clinical cases of
foot-and-mouth disease in National Laboratories as part of their training.

National Laboratories shall collaborate with the Community Reference Laboratory and other National
Laboratories to develop improved diagnostic methods and exchange relevant materials and information.

National Laboratories shall participate in external quality assurance and standardisation exercises organised
by the Community Reference Laboratory.

National Laboratories shall use tests and standards that meet or exceed the criteria laid down in Annex XIII.
National Laboratories shall provide the Commission on request with data proving that the tests in use
meet or exceed the requirements.

National Laboratories should have the competence to identify all vesicular disease viruses and encephalomy-
ocarditis virus in order to avoid delays in diagnosis and consequently in implementing control measures
by the competent authorities.

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13.

National Laboratories shall cooperate with other laboratories designated by the competent authorities for
performing tests, for example serological tests, that do not involve handling of live foot-and-mouth disease
virus. These laboratories shall not carry out virus detection in samples taken from suspect cases of vesicular
diseases. Such laboratories need not comply with the bio-security standards referred to in Annex XII,
point 1, but must have established procedures which ensure that the possible spread of foot-and-mouth
disease virus is effectively prevented.

Samples giving inconclusive results in tests must be transmitted to the National Reference Laboratory for
carrying out confirmatory tests.

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ANNEX XVI

FUNCTIONS AND DUTIES OF A COMMUNITY REFERENCE LABORATORY FOR FOOT-AND-MOUTH
DISEASE

The functions and duties of the Community Reference Laboratory referred to in Article 69 for foot-and-mouth
disease shall be as follows:

1.

1.1.

To ensure liaison between the national laboratories of the Member States and to provide optimal methods for the
diagnosis of foot-and-mouth disease in livestock, and differential diagnosis of other vesicular viral diseases, where
necessary, for each Member State specifically by:

regularly receiving field samples from Member States and countries geographically or commercially linked
to the European Union in terms of trade in animals of susceptible species or products derived from such
animals with a view to monitoring the disease situation globally and regionally, to estimating and where
possible predicting the risk evolving from emerging virus strains and particular epidemiological situations
and determining the identity of the virus, where necessary in close collaboration with OIE designated
regional reference laboratory and the WRL;

1.2.

typing and full antigenic and genomic characterisation of vesicular viruses from the samples referred to in
point 1.1 and communicating the results of such investigations without delay to the Commission, the
Member State, and the National Laboratory concerned;

1.3.

building up and maintaining an up-to-date collection of vesicular virus strains;

1.4.

building up and maintaining an up-to-date collection of specific sera against vesicular virus strains;

1.5.

advising the Commission on all aspects related to foot-and-mouth disease vaccine strain selection and use.

2.

To support the functions of National Laboratories, in particular by:

2.1.

2.2.

2.3.

2.4.

storing and supplying National Laboratories with reagents and materials for use in diagnosis of foot-and-
mouth disease such as virus and/or inactivated antigens, standardised sera, cell lines and other reference
reagents;

retaining expertise on foot-and-mouth disease virus and other pertinent viruses to enable rapid differential
diagnosis;

promoting harmonisation of diagnosis and ensuring proficiency of testing within the Community by
organising and operating periodic comparative trials and external quality assurance exercises on foot-and-
mouth disease diagnosis at Community level and the periodic transmission of the results of such trials to
the Commission, the Member States, and National Laboratories;

carrying out research studies with the objective of developing improved methods of disease control in
collaboration with National Laboratories and as agreed in the annual work plan of the Community
Reference Laboratory.

3.

To provide information and carry out further training, in particular by:

3.1.

gathering data and information on the methods of diagnosis and differential diagnosis used in National
Laboratories and the distribution of such information to the Commission and the Member States;

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3.2.

making and implementing the necessary arrangements for the further training of experts in laboratory
diagnosis with a view to harmonising diagnostic techniques;

3.3.

keeping abreast of developments in foot-and-mouth disease epidemiology;

3.4.

organising an annual meeting where representatives of the National Laboratories may review diagnostic
techniques and the progress of coordination.

4.

5.

6.

7.

8.

To perform experiments and field trials in consultation with the Commission directed towards an improved
control of foot-and-mouth disease.

To review at the annual meeting of National Reference Laboratories the contents of Annex XIII defining
the tests and standards for foot-and-mouth disease diagnosis within the European Union.

To cooperate with the national reference laboratories of candidate countries in accordance with this Annex.

The Community Reference Laboratory shall operate according to recognised conditions of strict disease
security as indicated in ‘Minimum Standards for Laboratories working with foot-and-mouth disease virus
in vitro and in vivo’, European Commission for the control of foot-and-mouth disease — 26th Session,
Rome, April 1985, as amended by Appendix 6 (ii) of the report to the 30th Session of the European
Commission for the control of foot-and-mouth disease 1993, referred to in Annex XII to this Directive.

The Community Reference Laboratory shall provide assistance to the Commission as required on the
disease security measures to be taken by the National Laboratories in matters of foot-and-mouth disease
diagnosis.

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ANNEX XVII

CRITERIA AND REQUIREMENTS FOR CONTINGENCY PLANS

Member States shall ensure that contingency plans meet at least the following requirements:

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

Provision shall be made to ensure the legal powers necessary for the implementation of contingency
plans and allow for a rapid and successful eradication campaign.

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 a foot-and-mouth disease epizootic.

A chain of command shall be established guaranteeing a rapid and effective decision-making process
for dealing with foot-and-mouth disease epizootics. A central decision-making unit shall be in charge
of the overall direction of control strategies and the chief veterinary officer shall be a member of this
unit.

Each Member State must be prepared to immediately establish a functional national disease control
centre in the event of an outbreak, which shall coordinate the implementation of all decisions taken in
the central decision-making unit. A permanently operational coordinator shall be appointed to
guarantee the prompt establishment of the centre.

Detailed plans shall be available to enable a Member State to be prepared for the immediate
establishment of local disease control centres in the event of foot-and-mouth disease outbreaks in order
to implement disease control and environment protection measures at a local level.

Member States shall ensure the cooperation between the national disease control centre, the local
disease control centres and environmental competent authorities and bodies in order to ensure that
actions on veterinary and environmental safety issues are appropriately coordinated.

A permanently operational expert group shall be created, where necessary in collaboration with other
Member States, to maintain expertise and assist the relevant authority in qualitative disease preparedness.

Provision must be made for adequate resources to ensure a rapid and effective campaign, including
personnel, equipment and laboratory capacity.

An up-to-date operations manual shall be available. It shall describe in detail and in a comprehensive
and practical way all the actions procedures, instructions and control measures to be employed in
handling an outbreak of foot-and-mouth disease.

Detailed plans shall be available for emergency vaccination.

Staff shall be regularly involved in:

11.1.

training in clinical signs, epidemiological enquiry and control of epizootic diseases;

11.2.

real-time alert exercises, conducted as follows:

11.2.1.

11.2.2.

11.2.3.

two times within a five years period, the first of which should not have started later than 3 years after
the approval of the plan, or

during the five years period after an outbreak of a major epizootic disease has been effectively controlled
and eradicated, or

one of the two exercises referred to in paragraph 11.2.1 is replaced by a real-time exercise required
within the framework of contingency plans for other major epidemic diseases affecting terrestrial
animals, or

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11.2.4.

11.3.

12.

13.

14.

15.

by way of derogation from paragraph 11.2.1 and subject to appropriate provisions in the contingency
plan, Member States with a limited population of animals of susceptible species arrange for the
participation in and contribution to real-time exercises carried out in a neighbouring Member States
and alarm-drills are carried out as provided for in paragraph (g) (ii) of Annex VII of Directive 2001/89/
EC in relation to all animals of species susceptible to foot-and-mouth disease.

Training in communication skills to provide ongoing disease awareness campaigns for authorities,
farmers and veterinarians.

Contingency Plans shall be prepared taking into account the resources needed to control a large number
of outbreaks occurring within a short time and caused by several antigenically distinct serotypes or
strains as it may be necessary amongst others in the case of deliberate release of foot-and-mouth disease
virus.

Without prejudice to veterinary requirements, contingency plans shall be prepared with a view to
ensuring that in the event of an outbreak of foot-and-mouth disease, any mass disposal of animal
carcasses and animal waste is done without endangering human health and without using processes or
methods which prevent any avoidable damage to the environment and in particular:

(i)

with a minimum risk to soil, air, surface and groundwater, to plants and animals,

(ii) with a minimum nuisance through noise or odours,

(iii) with a minimum adverse effect to the countryside or places of special interest.

Such plans shall include the identification of appropriate sites and undertakings for the treatment or
disposal of animal carcasses and animal waste in the event of an outbreak.

Member State shall ensure that farmers, the rural populace and the population in general are kept
informed. Direct and accessible contact shall be provided for the inhabitants of affected areas (inter alia
via helplines), as well as information through the national and regional media.

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ANNEX XVIII

PART A

Measures in case of confirmation of the presence of foot-and-mouth disease in wild animals

1.

As soon as confirmation of a primary case of foot-and-mouth disease in wild animals of susceptible species has
taken place, in order to reduce the spread of disease, the competent authority of a Member State shall
immediately:

(a)

notify the primary case in accordance with Annex II;

(b)

epidemiologists. The expert group shall assist the competent authority in:

(i)

(ii)

studying the epidemiological situation and defining an infected area,
provisions laid down in point 4(b) of Part B,

in accordance with the

establishing appropriate measures to be applied in the infected area in addition to the ones referred
to in points (c) and (d); these measures may include suspension of hunting and a ban in feeding wild
animals,

(iii)

drawing up the eradication plan to be submitted to the Commission in accordance with Part B,

(iv)

carrying out audits to verify the effectiveness of the measures adopted to eradicate foot-and-mouth
disease from the infected area;

(c)

immediately place under official surveillance holdings keeping animals of susceptible species in the
defined infected area and shall in particular order that:

(i)

(ii)

an official census be carried out of all species and categories of animals of susceptible species 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 holdings,
the first census carried out may be done on the basis of an estimate,

all animals of susceptible species on the holdings situated in the infected area be kept in their living
quarters or some other place where they can be isolated from wild animals. Wild animals must not
have access to any material which may subsequently come in contact with animals of susceptible
species on the holdings,

(iii) no animal of a susceptible species enter or leave the holding save where authorised by the competent

authority having regard to the epidemiological situation,

(iv)

appropriate means of disinfection be used at the entrance and exits of buildings housing animals of
susceptible species and of the holding itself,

(v)

appropriate hygiene measures be applied by all persons coming in contact with wild animals, to
reduce the risk of spread of foot-and-mouth disease virus, which may include a temporary ban on
persons having been in contact with wild animals from entering a holding keeping animals of
susceptible species,

(vi)

all dead or diseased animals of susceptible species with foot-and-mouth disease symptoms on a
holding be tested for the presence of foot-and-mouth disease,

(vii) no part of any wild animals, whether shot or found dead, as well as any material or equipment
which could be contaminated with foot-and-mouth disease virus shall be brought into a holding
keeping animals of susceptible species,

(viii) animals of susceptible species, their semen, embryos or ova shall not be moved from the infected

area for the purpose of intra-Community trade;

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(d)

arrange that all wild animals shot or found dead in the defined infected area are inspected by an official
veterinarian and examined for foot-and-mouth disease to officially rule out or confirm foot-and-mouth
disease in accordance with the definition for an outbreak in Annex I. Carcasses of all wild animals found
positive as regards foot-and-mouth disease shall be processed under official supervision. Where such
testing proves negative as regards foot-and-mouth disease, 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;

(e)

ensure that the foot-and-mouth disease virus isolate is subject to the laboratory procedure required to
identify the genetic type of virus and its antigenic characteristic in relation to existing vaccines strains.

2.

3.

If a case of foot-and-mouth disease has occurred in wild animals 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.

By way of derogation to the provisions in point 1 specific measures may be adopted in accordance with the
procedure referred to in Article 89(3), if a case of foot-and-mouth disease has occurred in wild animals in an
area of a Member State where extensive keeping of domestic animals of susceptible species makes certain
provisions in paragraph 1 inapplicable.

PART B

Plans for the eradication of foot-and-mouth disease in wild animals

1. Without prejudice to the measures laid down in Part A, Member States shall submit to the Commission within
90 days from the confirmation of the primary case of foot-and-mouth disease in wild animals 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.

2.

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 89(3). 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 and possible approval
in accordance with the procedure referred to in
Article 89(3).

3.

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

4.

The plan mentioned in paragraph 1 shall contain information on:

(a)

the results of the epidemiological investigations and controls carried out in accordance with Part A and
the geographical distribution of the disease;

(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:

(i)

the results of the epidemiological investigations carried out and the geographical distribution of the
disease,

(ii)

the wild animal population in the area,

(iii)

the existence of major natural or artificial obstacles to movements of wild animals;

(c)

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

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(d)

(e)

(f)

(g)

(h)

(i)

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 groups of wild animals with limited
contacts to other groups of wild animals in and around the infected area;

the approximate number of groups of wild animals referred to in paragraph (e) and their size in and
around the infected area;

specific efforts made to determine the extent of the infection in wild animals, by investigation of wild
animals shot by hunters or found dead, and by laboratory testing, including age-stratified epidemiological
investigations;

the measures adopted to reduce spread of disease due to movements of wild animals and/or contact
between groups of wild animals; these measures may include a prohibition of hunting;

the measures adopted to reduce the population of wild animals and in particular young animals of
susceptible species in the wild animal population;

(j)

the requirements to be complied with by hunters in order to avoid any spread of the disease;

(k)

the method of removal of wild animals found dead or shot, which shall be based on:

(i)

processing under official supervision, or

(ii)

inspection by an official veterinarian and laboratory tests as provided for in Annex XIII. Carcasses
of all wild animals found positive as regards foot-and-mouth disease shall be processed under
official supervision. Where such testing proves negative as regards foot-and-mouth disease, 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;

(l)

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

(i)

the geographical area where the animal was found dead or shot,

(ii)

the date on which the animal was found dead or shot,

(iii)

the person who found or shot the animal,

(iv)

the age and sex of the animal,

(v)

if shot: symptoms before shooting,

(vi)

if found dead: the state of the carcass,

(vii)

laboratory findings;

(m)

(n)

(o)

(p)

surveillance programmes and prevention measures applicable to the holdings keeping animals of
susceptible species situated in the defined infected area, and if necessary, in its surroundings, including
the transport and movement of animals of susceptible species within, from and to the area; these measures
shall at least include the ban of moving animals of susceptible species, their semen, embryos or ova from
the infected area for the purposes of intra-Community trade;

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;

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

the system established in order that the expert group appointed in accordance with point 1(b) in Part A
can review on a regular basis the results of the eradication plan;

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(q)

the disease monitoring measures that shall be enforced after a period of at least 12 months has elapsed
from the last confirmed case of foot-and-mouth disease in wild animals in the defined infected area; these
monitoring measures shall stay in place for at least 12 months and shall at least include the measures
already enforced in accordance with points (g), (k) and (l).

5.

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 6 months.

6. More detailed rules relating to the establishment of plans for the eradication of foot-and-mouth disease in wild

animals may be adopted in accordance with the procedure referred to in Article 89(3).

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ANNEX XIX

DEADLINES FOR TRANSPOSITION INTO NATIONAL LAW

Directive

85/511/EEC

90/423/EEC

Deadline for transposition

1 January 1987

1 January 1992

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ANNEX XX

CORRELATION TABLE

This Directive

Directive 85/511/EEC

Article 1, paragraph 1 (a)

Article 1

Article 1, paragraph 1 (b)

Article 1, paragraph 2

—

—

Article 2 (a)

Article 2 (a)

Article 2 (b) to (h) and (l) to (y)

—

Article 2 (i)

Article 2 (j)

Article 2 (k)

Article 3 (1) (a)

Article 3 (1) (b) and (c)

Article 3 (2)

Article 4 (1)

Article 4 (2)

Article 2 (d)

Article 2 (e)

Article 2 (c)

Article 3

—

—

—

Article 4 (1), first subparagraph

Article 4 (3) first sentence

Article 4 (1) second subparagraph

Article 4 (3) (a)

Article 4 (3) (b)

Article 4 (3) (c)

Article 4 (3) (d)

Article 4 (3) (e)

Article 4 (3) (f)

Article 4 (3) (g)

Article 5 (1) (a)

Article 4 (1) second subparagraph first indent, first part
of sentence

Article 4 (1) second subparagraph first indent, second
part of sentence

—

Article 4 (1) second subparagraph second and third
indent

Article 4 (1) second subparagraph ninth indent

Article 4 (1) second subparagraph tenth indent

—

Article 4 (1) second subparagraph fifth indent

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This Directive

Directive 85/511/EEC

Article 5 (1) (b)

Article 5 (1) (c)

Article 5 (1) (d)

Article 5 (2)

Article 5 (3)

Article 6 (1)

Article 6 (2)

Article 7

Article 8

Article 9

Article 4 (1) second subparagraph fourth indent

Article 4 (1) second subparagraph seventh indent

Article 4 (1) second subparagraph eighth indent

Article 4 (1) second subparagraph sixth indent

—

Article 4 (2)

—

—

—

Article 4 (3)

Article 10 (1) (a) first sentence

Article 5 (2) first indent

Article 10 (1) (a) second sentence

—

Article 10 (1) (b) first subparagraph

Article 5 (1)

Article 10 (1) (b) second subparagraph

Article 5 (3)

Article 10 (1) (c) first sentence

Article 5 (2) second and fourth indent

Article 10 (1) (c) second and third sentences

—

Article 10 (1) (d)

Article 10 (2) (a)

Article 10 (2) (b)

Article 10 (2) (c)

Article 11 (1)

Article 11 (2)

Article 11 (3)

Article 11 (4)

Article 5 (2) fifth and sixth indent

Article 5 (2) seventh indent

—

Article 5 (2) eighth indent

Article 10

—

—

—

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This Directive

Directive 85/511/EEC

Article 12 (relating to meat)

Article 5 (2) third indent

Article 12 (relating to other substances)

—

Article 13 (1)

Article 13 (2)

Article 14

Article 15

Article 16

Article 17

Article 18 (1)

Article 18 (2)

Article 18 (3)

Article 18 (4)

Article 19 (1) to (4)

Article 19 (5)

Article 20

Article 21 (1)

Article 21 (2)

Article 21 (3)

Article 21 (4) to (6)

Article 22 (1) (a)

Article 22 (1) (b)

Article 22 (1) (c)

Article 22 (2)

Article 23 (a)

Article 5 (2) ninth indent and Article 7

—

—

—

—

—

Article 6

Decision 88/397/EEC

Article 6 (1) second subparagraph

—

Article 8

—

Article 6 (3)

—

Article 9 (1)

—

—

Article 9 (2) (a) first indent

Article 9 (2) (a) second indent

Article 9 (2) (a) third indent first part of sentence

Article 9 (2) (a) third indent second part of sentence

Article 9 (2) (a) fifth to sixth indent

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This Directive

Directive 85/511/EEC

Article 23 (b)

Article 23 (c)

Article 23 (d)

Article 24 (1) (a)

Article 24 (1) (b) to (f)

Article 24 (2) (a)

Article 24 (2) (b)

Article 24 (2) (c)

Article 24 (2) (d)

Article 25

Article 26

Article 27

Article 28

Article 29

Article 30

Article 31

Article 32

Article 33

Article 34

Article 35

Article 36 (1) (a)

Article 36 (1) (b)

Article 36 (2)

Article 36 (3)

Article 37 (1)

—

—

—

—

—

Article 9 (2) (a) seventh indent last part of sentence

—

Article 9 (2) (a) fourth indent

—

—

—

—

—

—

—

—

—

—

—

—

Article 9 (2) (b) first sentence

—

Article 9 (2) (b) second sentence

—

—

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This Directive

Directive 85/511/EEC

Article 37 (2)

Article 38 (1)

Article 9 (3) (a)

Article 9 (3) (a) second indent first part

Article 38 (2) (a)

Article 9 (3) (a) second indent last part

Article 38 (2) (b) to (d)

Article 38 (3)

Article 38 (4)

Article 38 (5)

Article 39

Article 40

Article 41

Article 42

Article 43

—

—

—

—

—

—

—

—

—

Article 44 (1) (a)

Article 9 (3) (b)

Article 44 (1) (b) and (c)

Article 44 (2)

Article 45

Article 46

Article 47 (1)

Article 47 (2)

Article 48

Article 49 (a)

Article 49 (b)

—

—

—

—

Article 12, first indent

—

Article 12, second and third indent

Article 13 (1) first indent

Article 13 (1) third indent

Article 49 (c) and (d)

—

Article 50 (1) (a)

Article 13 (3) first subparagraph first sentence

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Directive 85/511/EEC

Article 50 (1) (b), (c) and (d)

Article 50 (2)

Article 50 (3)

—

—

Article 13 (3) second subparagraph

Article 50 (4) and (5)

Article 13 (3) third subparagraph

Article 50 (6)

Article 51 (1)

Article 51 (2)

Article 52

Article 53

Article 54

Article 55

Article 56

Article 57

Article 58

Article 59

Article 60

Article 61

Article 62

Article 63

Article 64

—

Article 13 (3) first subparagraph first to sixth indent

—

—

—

—

—

—

—

—

—

—

—

—

—

—

Article 65 (a), (b) and (c)

Article 13 (1) second indent

Article 65 (d)

Article 66

Article 67

Article 13 (1) fourth indent

Article 13 (2) first and second subparagraph

Article 13 (2) second subparagraph

Article 68(1) (a) and (b)

Article 11 (1) first indent

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This Directive

Directive 85/511/EEC

Article 68 (1) (c) and (e)

Article 11 (1) second and third indent

Article 68 (1) (d)

Article 68 (2), (3) and (4)

—

—

Article 69

Article 70 (1)

Article 70 (2)

Article 71

Article 72

Article 73

Article 74

Article 75

Article 76

Article 77

Article 78

Article 79 (1)

Article 79 (2)

Article 79 (3)

Article 79 (4)

Article 80

Article 81

Article 82

Article 83

Article 84

Article 85

Council Decision 89/531/EEC

—

Article 13 (2) third subparagraph

—

Article 5 of Directive 90/423/EEC

—

—

—

—

—

—

Article 14 (1) first subparagraph second half sentence

Article 14 (1) third subparagraph second half sentence

—

—

Decision 91/666/EEC

—

—

—

Decision 91/665/EEC

—

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This Directive

Directive 85/511/EEC

Article 86

Article 87

Article 88

Article 89

Article 90

Article 91

—

—

—

Articles 16 and 17

—

—

Article 92 (1)

Article 6 of Directive 90/423/EEC

Article 92 (2) first subparagraph

—

Article 92 (2) second and third subparagraphs

Article 5(4) of Directive 90/423/EEC

Article 93

Article 94

Article 95

Annex I

Annex II

Annex III

Annex IV

Annex V

Annex VI

Annex VII

Annex VIII

Annex IX Part A

Annex IX Part B

Annex X

Annex XI Part A

Annex XI Part B

Article 19

—

Article 20

—

—

—

—

—

—

—

—

—

—

—

Annex B

Annex A

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This Directive

Directive 85/511/EEC

Annex XII

Annex XIII

Annex XIV

Annex XV

Annex XVI

Annex XVII

Annex XVIII

Annex XIX

Annex XX

Financial Statement

—

—

Decision 91/666/EEC

—

Decision 89/531/EEC

Decision 91/42/EEC

—

—

—

—