2001/279/EC: Commission Decision of 5 April 2001 amending Decision 2001/246/EC laying down the conditions for the control and eradication of foot-and-mouth disease in the Netherlands in application of Article 13 of Directive 85/511/EEC (Text with EEA relevance) (notified under document number C(2001) 1070)
Date: 2001-04-05
Institutions: European Commission
Subjects: Netherlands, foot-and-mouth disease, slaughter of animals, vaccination

6.4.2001

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Official Journal of the European Communities

L 96/19

COMMISSION

COMMISSION DECISION

of 5 April 2001

amending Decision 2001/246/EC laying down the conditions for the control and eradication of
foot-and-mouth disease in the Netherlands in application of Article 13 of Directive 85/511/EEC

(notified under document number C(2001) 1070)

(Text with EEA relevance)

(2001/279/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to 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 (1), as last
amended by Directive 92/118/EEC (2), and in particular Article
10 thereof,

Having regard to Council Directive 85/511/EEC of 18
November 1985 introducing Community measures for the
control of foot-and-mouth disease (3), as last amended by the
Act of Accession of Austria, Finland and Sweden, and in partic-
ular Article 13(3) thereof,

Whereas:

(1)

(2)

(3)

Based on a programme to employ suppressive vaccina-
tion submitted by the competent authorities of the Neth-
the Commission adopted Decision 2001/
erlands,
246/EC (4) laying down the conditions for the approval
and eradication of foot-and-mouth disease in the Nether-
lands in application of Article 13 of Directive 85/
511/EEC.

Based on a programme to employ protective vaccination
submitted by the competent authorities of the United
Kingdom,
the Commission adopted Decision 2001/
257/EC (5) laying down the conditions for the approval
and eradication of foot-and-mouth disease in the United
Kingdom in application of Article 13 of Directive 85/
511/EEC.

The competent authorities of the Netherlands have now
presented to the Commission a programme to employ
in addition to the measures laid down in Decision 2001/
246/EC protective vaccination as an additional
instru-
ment to control and eradicate foot-and-mouth disease,
taking into account the epidemiological situation and

(1) OJ L 224, 18.8.1990, p. 29.
(2) OJ L 62, 15.3.1993, p. 49.
(3) OJ L 315, 26.11.1985, p. 11.
(4) OJ L 88, 28.3.2001, p. 21.
(5) OJ L 91, 31.3.2001, p. 98.

the high density of susceptible animals in certain parts
of the territory.

The principles provided for in Article 13 of Directive
85/511/EEC require to balance the decision on resorting
to vaccination against basic Community interests which
must not be endangered.

Recourse to any kind of vaccination will inevitably jeop-
ardise the foot-and-mouth disease status in terms of
international trade not only for the Member State or part
of its territory where vaccination is carried out.

The Commission prior to taking a Decision on emer-
gency vaccination must ensure that the measures to be
taken include at least those provided for in Article 13(3)
first to sixth indent of Directive 85/511/EEC.

It is the purpose of this Decision to define the condi-
tions under which the Netherlands may apply emer-
gency vaccination without prejudice to Commission
Decision 2001/223/EC (6) as last amended.

The measures provided for in this Decision are in
accordance with the opinion of the Standing Veterinary
Committee,

(4)

(5)

(6)

(7)

(8)

HAS ADOPTED THIS DECISION:

Article 1

Decision 2001/246/EC is amended as follows:

1. A third paragraph is added to Article 1 as follows:

‘3. Protective vaccination shall mean emergency vaccination
of bovine animals in identified holdings situated in the
vaccination zone, which is carried out exclusively in
conjunction with pre-emptive killing of certain catego-
ries of other animals of susceptible species as defined in
paragraph 1 whether or not
in conjunction with
suppressive vaccination as defined in paragraph 2.

(6) OJ L 82, 22.3.2001, p. 29.

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It is aimed at an urgent reduction of the amount of virus
circulating and the risk of virus spreading beyond the
perimeters of the area, however it is carried out under
the condition that animals of susceptible species vacci-
nated under the conditions of protective vaccination are
not subject to pre-emptive killing.’

2. Article 2 is replaced by the following:

‘Article 2

1. Without prejudice to Council Directive 85/511/EEC,
and in particular Articles 4, 5 and 9 thereof, the competent
authorities of the Netherlands may decide on resorting to
emergency vaccination under the conditions set out in the
Annexes.

Before commencing suppressive and protective vacci-
2.
nation under
the conditions laid down respectively in
Annex I and Annex II, the Netherlands shall ensure that the
Member States and the Commission are officially informed
on the details concerning the geographical and adminis-
trative definition of the vaccination zone, the number of
holdings and animals by species affected and the time when
vaccination will be started and accomplished and the
circumstances motivating the decision to implement the
measures.

Subsequently the Netherlands shall ensure that the informa-
tion submitted in accordance with the first subparagraph is
completed without undue delay with the details concerning
the killing of vaccinated animals, in particular the number
of animals killed,
the number of holdings and animals
affected, the time the killing was completed, and the modifi-
cations of the restrictions applied in the areas concerned
with regard to suppressive vaccination carried out under the
conditions laid down in Annex I and the maintenance of
restrictions imposed on movement of
live animals and
certain of their products from animals which have been
subject
to protective vaccination carried out under the
condition laid own in Annex II.’

3. The Annex is replaced by the Annexes to this Decision.

This Decision is addressed to the Member States.

Article 2

Done at Brussels, 5 April 2001.

For the Commission

David BYRNE

Member of the Commission

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L 96/21

ANNEX I

Conditions for the use of suppressive vaccination in the control and eradication of foot-and-mouth disease in
application of Article 13(3) of Directive 85/511/EEC

1.

Extent of the geographical area in which suppressive
vaccination is to be carried out

The vaccination zone shall be within the area defined in Annex III(A).

The restrictions applicable in the vaccination zone shall be those in Annex I and
where applicable in Annex II of this Decision, without prejudice to the provisions in
Articles 4, 5 and 9 of Directive 85/511/EEC.

The vaccination zone must be situated in the parts of the territory of the Nether-
lands included in Annex I of Commission Decision 2001/223/EC as last amended.

2.

Species and age of the animals to be vaccinated

All animals of susceptible species independently of their sex, age and gestational or
productive status

3.

Duration of the vaccination campaign

The campaign must be completed within 48 hours on holdings situated within a
radius of up to 2 km around a holding placed under the restrictions laid down in
Articles 4 or 5 of Directive 85/511/EEC.

Specific standstill of vaccinated animals and products
of vaccinated animals

The measures laid down in Article 4 of Directive 85/511/EEC shall apply to
holdings on which suppressive vaccination is to be carried out until the animals
vaccinated under the terms of suppressive vaccination have been killed. Where
applicable such holdings will continue to be under the restrictions laid down in
Annex II with regard to bovine animals.

identification and special registration of the

Special
vaccinated animals

The measures laid down in Article 4 of Directive 85/511/EEC shall apply to
holdings on which suppressive vaccination is to be carried out.

An indelible mark must be applied to vaccinated animals at the time of vaccination.

Other matters appropriate to the suppressive vaccination

Adjustment of zones established in accordance with
Article 9 of Directive 85/511/EEC

A surveillance zone of at least 10 km around the vaccination zone referred to in
point 1.

4.

5.

6.

6.1.

6.2.

Period for which the measures applied in the zones
established in accordance with Article 9 of Directive
85/511/EEC are maintained

The measures applied in the protection zone referred to in point 6.1 must be
maintained for at least 15 days after the elimination of all animals of susceptible
species vaccinated under the terms of suppressive vaccination and the completion
of the preliminary cleansing and disinfection on the holding where suppressive
vaccination was carried out.

The measures applied in the surveillance zone must remain in force in the protec-
tion zone for at least another 15 days.

The measures applied in the surveillance zone must remain in force for at least 30
days after the elimination of all animals of susceptible species vaccinated under the
terms of suppressive vaccination and the completion of the preliminary cleansing
and disinfection on the holding where suppressive vaccination was carried out and
where applicable the surveillance zone shall be maintained in accordance with point
6.2. of Annex II.

Vaccination must be carried out by an official of the competent authorities. Neces-
sary measures must be in place to avoid possible spread of virus. Any residual
quantities of vaccine must be returned to the point of vaccine distribution with a
written record on number of animals vaccinated and the number of doses used.

6.3.

Execution of the vaccination campaign

6.4.

Vaccine to be used

The inactivated vaccine of at least 6 PD
to be used must be suitably formulated for
the species concerned and be effective against the virus type circulating. It shall be
used in accordance with the instructions of the manufacturer.

50

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6.5.

Elimination of all animals of susceptible species on
holdings where suppressive vaccination was carried out

the earliest possible moment when the
Without undue delay and at
conditions referred to in Article 1(2) third subparagraph, first and second indent do
no longer apply.

least at

Killing of animals may be carried out in designated premises outside the holding, if
at least 14 days have elapsed since the completion of vaccination of susceptible
animals on the holding concerned.

The authorities must ensure proper cleansing and disinfection of the premises after
each days operation.

6.6.

Information on implementation of this programme to
the Commission

A detailed report on the execution of the programme shall be provided to the
Commission and the Member States in the framework of a Standing Veterinary
Committee before the lifting of the restrictions referred to in points 6.1 and 6.2.

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Official Journal of the European Communities

L 96/23

Conditions for the use of protective vaccination in the control and eradication of foot-and-mouth disease in
application of Article 13(3) of Directive 85/511/EEC

ANNEX II

Extent of the geographical area in which protective
vaccination is to be carried out

The vaccination zone shall be within an area defined in Annex III(B).

The restrictions applicable in the vaccination zone shall be those in Annex IV of
this Decision, without prejudice to the provisions in Article 9 of Directive 85/
511/EEC.

Species and age of the animals to be vaccinated

All animals over 1 week of age independently of their sex and gestational or
productive status.

Duration of the vaccination campaign

The vaccination shall be completed within 7 days.

Specific standstill of vaccinated animals and products
of vaccinated animals

Measures laid down in Annex IV and the treatments of products derived from
vaccinated bovine animals as laid down in Annexes V, VI, VII-A and VII-B.

identification and special registration of the

Special
vaccinated animals

— Identification of all bovine animals in accordance with Regulation (EC) No

1760/2000 (OJ L 204, 11.8.2000, p. 1),

— on the spot ear-tagging of calves less than 20 days of age and application of an

indelible mark with subsequent issuing of passport,

— marking of vaccination status in the passport,

— entering vaccination details in the database established in accordance with

Regulation (EC) No 1760/2000.

Other matters appropriate to the protective vaccination

Adjustment of zones established in accordance with
Article 9 of Directive 85/511/EEC

A surveillance zone of at least 10 km around the vaccination zone referred to in
point 1.

Period for which the measures applied in the zones
established in accordance with Article 9 of Directive
85/511/EEC are maintained

Without prejudice to the provisions in Article 9 of Directive 85/511/EEC and of
Commission Decision 2001/223/EC the measures applied in the vaccination zone
must remain in force until the measures are lifted in accordance with point 6.6.

1.

2.

3.

4.

5.

6.

6.1.

6.2.

6.3.

Execution of the vaccination campaign

6.4.

Vaccine to be used

Vaccination must be carried out by an official of the competent authorities. Neces-
sary measures must be in place to avoid possible spread of virus. Any residual
quantities of vaccine must be returned to the point of vaccine distribution with a
written record on number of animals vaccinated and the number of doses used.

The inactivated vaccine of at least 6 PD
to be used must be suitably formulated for
the species concerned and be effective against the virus type circulating. It shall be
used in accordance with the instructions of the manufacturer.

50

6.5.

Information on implementation of this programme to
the Commission

A detailed report on the execution of the programme shall be provided to the
Commission and the Member States in the framework of a Standing Veterinary
Committee before the lifting of the restrictions referred to in points 6.1 and 6.2.

6.6.

Lifting of restrictions

In accordance with Article 16 and without prejudice to Article 9 of Directive
85/511/EEC and not earlier than

— 12 months after the completion of the measures in point 3 or 12 months after

the last outbreak in the vaccination zone, whichever is the latest, or

— 3 months after the slaughter of the last vaccinated animal.

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ANNEX III

(A) Suppressive vaccination zone:

Areas in the provinces of Gelderland, Overijssel, Noord-Brabant and Flevoland in the Netherlands as notified and
described in accordance with Article 2(2).

(B) Protective vaccination zone:

An area of about 25 km around Oene as notified and described in accordance with Article 2(2).

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Official Journal of the European Communities

L 96/25

MEASURES APPLICABLE IN THE VACCINATION ZONE WITH REGARD TO BOVINE ANIMALS
VACCINATED UNDER THE TERMS OF PROTECTIVE VACCINATION

ANNEX IV

1. The Netherlands shall ensure that the following measures are applied in the vaccination zone during the period from
the beginning of the vaccination until at least 30 days have elapsed following the completion of the vaccination:

(a) Movement of live vaccinated bovine animals is prohibited within and out of the vaccination zone.

Derogating from the prohibition above and after clinical inspection of the animals in question and of the herds of
origin or dispatch, the competent authorities may authorise the direct transport of live bovine animals for
immediate slaughter in a slaughterhouse designated by the competent authority and situated within the vaccination
zone or in exceptional circumstances to be authorised on a case by case basis by the competent authorities
preferably close to that zone.

(b) Fresh meat produced from vaccinated animals slaughtered during the period referred to in this paragraph shall bear
the stamp provided for in Article 5a of Directive 72/461/EEC, shall be stored and transported separately from meat
not bearing the said stamp, and shall subsequently be transported in sealed containers to an establishment
designated by the competent authorities for treatment in accordance with Annex V.

(c) Milk and milk products produced from vaccinated animals during the period referred to in this paragraph may be
placed on the market within or out of the vaccination zone, provided that at least one of the treatments referred to
in Annexes VII-A and VII-B has been applied in an establishment located in the vaccination zone or, in exceptional
circumstances to be authorised on a case by case basis by the competent authorities outside that zone. This
treatment shall be certified by the competent veterinary authorities.

(d) The collection of semen for artificial insemination from male bovine animals kept in centres situated within the

vaccination zone shall be suspended.

Derogating from the prohibition above, the competent authorities may authorise the collection at semen collection
centres within the vaccination zone of semen from male bovine animals for the production of frozen semen to be
used within the vaccination zone, if it is ensured that the semen collected during that period is stored separately for
at least 30 days and is dispatched only after the following measures have been taken:

1. the donor males have been vaccinated following a negative test for antibodies against foot-and-mouth disease

virus, and

2. a negative result has been achieved in all susceptible animals present at the time on the semen collection centre,
in a virus isolation test or in an approved test for antibody against non-structural proteins carried out at end of
the quarantine period for the semen.

(e) Collection of ova and embryos from donor female bovines shall be prohibited.

2. The Netherlands shall ensure that the following measures are applied in the vaccination zone after the completion of

the measures laid down in paragraph 1 and until the restrictions on the vaccination zone are lifted:

(a) Intra-Community trade in bovine animals vaccinated against foot-and-mouth disease is prohibited.

(b) Intra-Community trade in semen, ova and embryos of bovine animals vaccinated against foot-and-mouth disease is

prohibited.

(c) Collection of ova shall be prohibited.

(d) Movement of bovine animals may only take place under the following conditions:

1. Movement out of the vaccination zone of non-vaccinated bovine animals other than those referred to in point
(3) below may be authorised not earlier than 3 months after completion of all vaccination and in accordance
with Directive 85/511/EEC.

Derogating from the provisions in the first subparagraph above, the Netherlands may authorise the transport of
non-vaccinated bovine animals to a slaughterhouse outside the vaccination zone for immediate slaughter,
provided that the meat shall be subjected to the treatment in Annex VI.

2. Movement out of the vaccination zone of vaccinated bovine animals shall be prohibited, unless 12 months have
elapsed after the completion of the measures referred to in paragraph 1 or 12 months after the last outbreak in
the zone, whichever is the latest.

Derogating from the provisions in the first subparagraph, the Netherlands may authorise the transport of
vaccinated bovine animals to a designated slaughterhouse outside the vaccination zone for direct slaughter,
provided that the meat shall be subjected to the treatment in Annex VI.

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3. Non-vaccinated offspring of vaccinated dams, shall be prohibited from leaving the holding of origin unless

being transported to:
(i) either a slaughterhouse for immediate slaughter, the meat being subject to the treatment in Annex VI, or
(ii) to another holding within the vaccination zone, or
(iii) any holding after obtaining a negative result in a serological test for the detection of antibody against the

foot-and-mouth disease virus.

(e) The restrictions applied to fresh meat produced from vaccinated bovine animals as laid down in Annex VI, and to
meat products as laid down in Annex V, shall continue to apply until the restrictions on movements of vaccinated
bovine animals have been lifted in accordance with Article 16 of Directive 85/511/EEC, and in any case not earlier
than 12 months after the completion of vaccination or 12 months after the last outbreak in the vaccination zone
whichever is the latest, or until 3 months have elapsed after the slaughter of the last vaccinated bovine animal.

(f) The restrictions applied to fresh milk produced from vaccinated bovine animals and to milk products produced
from such milk as laid down in Annexes VII-A and VII-B shall continue to apply until the restrictions on
movements of vaccinated bovine animals have been lifted in accordance with Article 16 of Directive 85/511/EEC,
and in any case not earlier than 12 months after the completion of vaccination and 12 months after the last
outbreak in the vaccination zone whichever is the latest, or until 3 months have elapsed after the slaughter of the
last vaccinated bovine animal.

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ANNEX V

TREATMENT OF MEAT TO ENSURE DESTRUCTION OF FOOT-AND-MOUTH DISEASE VIRUS

Treatment

Foot-and-mouth disease

(a) Heat treatment in a hermetically sealed container with an F
0

value of 3,00 or more

(b) Heat

treatment at a minimum temperature of 70 °C, which must be reached

throughout the meat

(c) Heat treatment in a hermetically sealed container to at least 60 °C for a minimum of
4 hours, during which time the core temperature must be at least 70 °C for 30
minutes

(d) Natural fermentation and maturation of not less than 9 months for boneless meat,
resulting in the following characteristics: aw value of not more than 0,93 and a pH
value of not more than 6,0

(e) As (d) above but meat may contain bone. All the necessary measures must be taken

to avoid cross contamination

(f) Heat treatment ensuring a core temperature of at least 65 °C is reached for the time
necessary to achieve a pasteurisation value (pv) equal to or more than 40

‘+’: Effectiveness recognised

+

+

+

+

+

+

ANNEX VI

TREATMENT OF FRESH MEAT

1. De-boned fresh meat:

Meat as described in Article 2(a) of Council 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)(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.

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ANNEX VII-A

TREATMENT OF MILK TO ENSURE DESTRUCTION OF FOOT-AND-MOUTH VIRUS IN MILK FOR HUMAN
CONSUMPTION

Treatment of milk must be carried out in accordance with paragraph 1 below and in any case 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 for human consumption must be subject to at least one of the following treatments:

1.1.

1.2.

1.3.

1.4.

1.5.

sterilisation at a level of at least F

03,

single UHT (1) treatment,

double HTST (2) treatment of milk with a pH above 7,0,

single HTST treatment of milk with a pH less than 7,0,

single HTST combined with another physical treatment by:

1.5.1. either a second heat treatment resulting in a negative reaction to the peroxidase test,

1.5.2. or lowering the pH < 6 for at least one hour,

1.5.3. or additional heating to 72 °C or more, combined with desiccation.

2.

Milk based products must be produced from milk after the treatment referred to in paragraph 1.

(1) UHT = Ultra High Temperature treatment at 130 °C for 2–3 sec.
(2) HTST = High Temperature Short Time pasteurisation at 72 °C for 15–17 sec or equivalent pasteurisation effect achieving a negative

reaction to a phosphatase test.

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ANNEX VII-B

TREATMENT OF MILK TO ENSURE DESTRUCTION OF FOOT-AND-MOUTH VIRUS IN MILK NOT
INTENDED FOR HUMAN CONSUMPTION AND IN MILK FOR ANIMAL CONSUMPTION

Treatment of milk and milk-based products must be carried out in accordance with paragraphs 1 to 3 below depending
on the intended use of the milk or milk-based products, and in any case necessary precautions must be taken to avoid
contact of the milk or milk based products with any potential source of foot-and-mouth virus after processing.

1.

1.1.

1.2.

1.3.

1.4.

Milk not intended for human consumption and milk intended for animal consumption must be subject to at least
one of the following treatments:

sterilisation at a level of at least F

03,

single UHT (1) combined with another physical treatment referred to in either paragraph 1.4.1. or 1.4.2.

double HTST (2),

single HTST combined with another physical treatment by:

1.4.1. either lowering the pH < 6 for at least one hour,

1.4.2. or additional heating to 72 °C or more, combined with desiccation.

2.

3.

4.

Milk-based products not intended for human consumption must be produced from milk after the treatments
referred to in paragraph 1.

Milk-based products intended for animal consumption must be produced from milk after one of the treatments
referred to in paragraph 1.1., 1.2. and 1.4.

Whey to be fed to pigs 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 130 °C for 2–3 sec.
(2) HTST = High Temperature Short Time pasteurisation at 72 °C for 15–17 sec or equivalent pasteurisation effect achieving a negative

reaction to a phosphatase test.