ANIMAL HEALTH PROBLEMS AFFECTING INTRA-COMMUNITY TRADE IN BOVINE ANIMALS AND SWINE REGULATIONS *

SUBSIDIARY LEGISLATION 437.48

ANIMAL HEALTH PROBLEMS AFFECTING

INTRA-COMMUNITY TRADE IN BOVINE

ANIMALS AND SWINE REGULATIONS *

10th December, 2004

LEGAL NOTICE 505 of 2004, as amended by Legal Notices 269 of 2010

and 9 of 2016 and 340 of 2020.

(1) The title of these regulations is the Animal Health

Problems affecting Intra-Community Trade in Bovine Animals and

Swine Regulations.

(2) The scope of these regulations is to implement the

regulations laid down under European Union Council Directive 64/

432/EEC on animal health problems affecting intra-Community

trade in bovine animals and swine

Provided that for the purposes of these regulations any

reference made under European Union Council Directive 64/432/

EEC to Annex F has now been harmonised under Commission

Regulation (EC) No 599/2004 of the 30th March 2004 concerning

the adoption of a harmonised model certificate and inspection

report linked to intra-Community trade in animals and products of

animal origin

Provided further the certificate found under Commission

Decision 599/2004 shall apply to these regulations.

(3) These regulations shall shall apply to intra-Community

trade in bovine animals and swine with the exception of feral pigs

as defined in Article 2(e) of the European Union Council Directive

80/217/EEC without prejudice to the provisions laid down in the

European Union Council Directives 80/215/EEC, 85/511/EEC, 88/

407/EEC, 89/608/EEC, 90/425/EEC, 90/429/EEC, 90/667/EEC, 91/

496/EEC, 91/628/EEC, 92/102/EEC, 92/119/EEC and Decision 90/

424/EEC.

(4) These regulations also transpose and implement Directive

2014/64/EU of the European Parliament and of the Council

amending Council Directive 64/432/EEC as regards computer

databases which are part of the surveillance networks in the

Member States.

Schedules A, B, C, D, E and F to the European Council Directive 64/432/EEC

(1)(a) The definitions given in article 2 of European Union

Council Directive 90/425/EEC relating to veterinary

checks applicable in trade in bovine and porcine

animals and in article 2 of European Union Council

Directive 91/628/EEC relating to animal welfare

during transport shall apply to these regulations.

(b) "Member States" means Member States of the

*These regulations have been repealed by Legal Notice 77 of 2025.

European Union;

"Third Countries'' means countries which are not

Member States within the European Union.

(2) In addition, the following definitions apply for the purposes

of these regulations -

"animals for breeding or production" means bovine animals

(including the species Bison bison and Bubalus bubalus) and swine

other than those referred to as animals for slaughter, including

those intended for breeding, milk or meat production, or draft

purposes, shows or exhibition with the exception of animals taking

part in cultural and sporting events;

"animal for slaughter'' means a bovine animal (including the

species Bison bison and Bubalus bubalus) or swine intended to be

taken to a slaughterhouse or assembly centre from which it may

only move to slaughter;

"approved veterinarian" means any veterinarian approved by the

Ve t e r i n a r y S e r v i c e s , i n a c c o r d a n c e w i t h t h e p r o v i s i o n s o f

regulation 14(3)(b);

"assembly centre" means holdings, collection centres and

markets, at which bovine animals or swine originating from

different holdings are grouped together to form consignments of

animals intended for trade. These assembly centres must be

approved for trading purposes and meet the requirements laid down

in regulation 11;

"brucellosis-free bovine herd" means a bovine herd which

satisfies the conditions laid down in Annex A. II, paragraphs 4, 5

and 6 to European Union Council Directive 64/432/EEC;

"competent authority'' means -

(i)

for Malta: the Veterinary Services as established under

article 2 of the Veterinary Services Act;

(ii) for a Member State: the central authority competent to

carry out veterinary checks in animal health or any

authority to which it has delegated that competence;

"compulsorily notifiable diseases" means the diseases listed in

Annex E (I) to European Union Council Directive 64/432/EEC;

"dealer" means any natural or legal person who buys and sells

animals commercially either directly or indirectly, who has a

regular turnover of these animals and who within a maximum of

thirty days of purchasing animals re-sells them or relocates them

from the first premises to other premises not within his ownership

and meets the conditions laid down in regulation 13;

"herd" means an animal or group of animals kept on a holding

(within the meaning of Article 2 (b) of Directive 92/102/EEC) 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;

"officially brucellosis-free bovine herd'' means a bovine herd

which satisfies the conditions laid down in Annex A. II, paragraphs

l, 2 and 3 to European Union Council Directive 64/432/EEC;

"officially brucellosis-free Member State'' means a Member State

which satisfies the conditions laid down in Annex A. II, paragraphs

10, 11 and 12 to European Union Council Directive 64/432/EEC;

"officially brucellosis-free region" means a region of a Member

State which satisfies the conditions laid down in Annex A. II,

paragraphs 7, 8 and 9 to European Union Council Directive 64/432/

EEC;

"officially enzootic-bovine-leukosis-free herd" means a herd

which satisfies the conditions laid down in Annex D, Chapter I,

Sections A and B, C and D to European Union Council Directive

64/432/EEC;

"officially enzootic-bovine-leukosis-free Member State or

r e g i o n " m e a n s a r e g i o n o r M e m b e r St a t e w h i c h m e e t s t h e

requirements laid down in Annex D, Chapter I, Sections E and F,

and G to European Union Council Directive 64/432/EEC;

"officially tuberculosis-free bovine herd" means a bovine herd

which satisfies the conditions laid down in Annex A. I, paragraphs

l, 2 and 3 to European Union Council Directive 64/432/EEC;

"officially tuberculosis-free Member State or region of a Member

State" means a Member State or part of a Member State which

satisfies the conditions laid down in Annex A. I, paragraphs 4, 5

and 6 to European Union Council Directive 64/432/EEC;

"official veterinarian" means the veterinarian appointed by the

competent authority of a Member State;

"region" means that part of a Member State’s territory which is

subject to inspection by the competent authorities

(i)

Belgium: province/provincie;

(ii)

Germany: Regierungsbezirk;

(iii)

Denmark: amt or island;

(iv)

France: department;

(v)

Italy: provincia;

(vi)

Luxemburg Netherlands: rrv,-kring;

(vii)

United Kingdom - England, Wales and Northern

Ireland: county;

(viii) Scotland: district or island area;

(ix) Ireland: county;

(x)

Greece: Nomos;

(xi)

Spain: provincia;

(xii)

Portugal: continente: distrito, and other parts of

Portugal’s territory: região autònoma;

(xiii) Austria: Bezirk;

(xiv) Sweden: län;

(xv) Finland: lääni/län.

Officially tuberculosis-free bovine herd

For the purposes of this section "bovine animals" means all bovine animals with

the exception of animals taking part in cultural or sporting events.

1. A bovine herd is officially tuberculosis-free if -

(a) all the animals are free from clinical signs of tuberculosis;

(b) all the bovine animals over six weeks old have reacted negatively to at

least two official intra-dermal tuberculin tests carried out in accordance

with Schedule B, the first six months after the elimination of any

infection from the herd and the second six months later or, where the

herd has been assembled solely from animals that originate in officially

tuberculosis-free herds, the first test shall be carried out at least sixty

days after assembly and the second shall not be required;

(c) following the completion of the first test referred to in (b), no bovine

animal over six weeks old has been introduced into the herd unless it

has reacted negatively to an intra-dermal tuberculin test performed and

assessed according to Schedule B and carried out either in the thirty

days prior to, or the thirty days after the date of its introduction into the

herd; in the latter case the animal(s) must be isolated physically from

the other animals of the herd in a way to avoid any direct or indirect

contact with the other animals until proven negative.

However, the competent authority may not require this test to be carried

out for movements of animals on its own territory if the animal is from

an officially tuberculosis-free herd, except in a Member State where, on

1 January 1998 and until the status of officially tuberculosis-free region

is obtained, the competent authority required such tests to be carried out

for animals moving between herds participating in a network system as

referred to in regulation 14.

2. A bovine herd will retain officially tuberculosis-free status if -

(a) the conditions detailed in 1(a) and (c) continue to apply;

(b) all animals entering the holding come from herds of officially

tuberculosis-free status;

(c) all animals on the holding, with the exception of calves under six weeks

old which were born in the holding, are subjected to routine tuberculin

testing in accordance with Schedule B at yearly intervals.

However, the competent authority of a Member State may, for the

Member State or part of the Member State where all the bovine herds

are subject to an official programme to combat tuberculosis, alter the

frequency of the routine tests as follows -

-

if the average - determined at 31 December of each year - of the

annual percentages of bovine herds confirmed as infected with

tuberculosis is not more than 1% of all herds within the defined

area during the two most recent annual supervisory periods, the

interval between routine herd tests may be increased to two years

and male animals for fattening within an isolated epidemiological

unit may be exempted from tuberculin testing provided that they

come from officially tuberculosis-free herds and that the

competent authority guarantees that the males for fattening will

not be used for breeding and will go direct for slaughter,

if the average - determined at 31 December of each year - of the

annual percentages of bovine herds confirmed as infected with

tuberculosis is not more than 0,2% of all herds within the defined

area during the two most recent biennial supervisory periods, the

interval between routine tests may be increased to three years

and/or the age at which animals have to undergo these tests may

be increased to twenty-four months,

if the average - determined at 31 December of each year - of the

annual percentages of bovine herds confirmed as infected with

tuberculosis is not more than 0,1% of all herds within the defined

area during the two most recent supervisory triennial periods, the

interval between routine tests may be increased to four years, or,

providing the following conditions are met, the competent

authority may dispense with tuberculin testing of the herds -

(1) before the introduction into the herd all the bovine animals

are subjected to an intra-dermal tuberculin test with negative

results; or

(2) all bovine animals slaughtered are examined for lesions of

tuberculosis and any such lesions are submitted to a

histopathological and bacteriological examination for

evidence of tuberculosis.

The competent authority may also, in respect of the Member State or a part

thereof, increase the frequency of tuberculin testing if the level of the disease has

3A. The officially tuberculosis-free status of a herd is to be suspended if -

(a) the conditions detailed in paragraph 2 are no longer fulfilled; or

(b) one or more animals are deemed to have given a positive reaction to a

tuberculin test, or a case oftuberculosis is suspected at post-mortem

examination.

When an animal is considered to be a positive reactor it will be removed

from the herd and slaughtered. Appropriate post-mortem, laboratory and

epidemiological examinations shall be carried out on the positive

reactor or the carcase of the suspect animal. The status of the herd will

remain suspended until such time as all laboratory examinations have

been completed. If the presence of tuberculosis is not confirmed, the

suspension of the officially tuberculosis-free status may be lifted

following a test of all animals over six weeks of age with negative

results at least forty-two days after the removal of the reactor

animal(s);or

(c) the herd contains animals of unresolved status as described in Schedule

B. In this case, the status of the herd is to remain suspended until the

animals’ status has been clarified. Such animals must be isolated from

the other animals of the herd until their status has been clarified, either

by a further test after forty-two days or by post-mortem and laboratory

examination;

(d) however, by way of derogation from the requirements of paragraph (c),

in a Member State where the competent authority carries out routine

herd testing using the comparative tuberculin test described in Schedule

B, and in the case of a herd where no confirmed reactor animals have

been disclosed for at least three years, the competent authority may

decide not to restrict the movement of other animals in the herd,

provided that the status of any inconclusive reactors is resolved by a

further test after forty-two days and that no animals from the holding

are allowed to enter into intra-Community trade until the status of any

inconclusive reactors has been resolved. If at this further test any animal

either gives a positive reaction or continues to give an inconclusive

reaction, then the conditions of paragraph (b) apply. If the presence of

disease is subsequently confirmed, all animals leaving the holding since

the time of the last clear herd test must be traced and tested.

3B. The officially tuberculosis-free status of the herd is to be withdrawn if the

presence of tuberculosis is confirmed by the isolation of M. bovis on laboratory

examination.

The competent authority may withdraw status if -

(a) the conditions detailed in point 2 are no longer fulfilled, or

(b) classical lesions of tuberculosis are seen at post-mortem examination, or

(c) an epidemiological enquiry establishes the likelihood of infection,

(d) or for any other reasons considered necessary for the purpose of

controlling bovine tuberculosis.

Tracing and checking is to be undertaken by the competent authority of any herd

considered to be epidemiologically related. The officially tuberculosis-free status of

a herd is to remain withdrawn until cleansing and disinfection of the premises and

utensils has been completed and all animals over six weeks of age have reacted

negatively to at least two consecutive tuberculin tests, the first no less than sixty

days and the second no less than four months and no more than twelve months after

the removal of the last positive reactor.

4. On the basis of information supplied in accordance with regulation 8, a

Member State or part of a Member State may be declared officially tuberculosis-free

according to the procedure laid down in Article 17 of the European Union Council

Directive 64/432/EEC if it meets the following conditions -

(a) the percentage of bovine herds confirmed as infected with tuberculosis

has not exceeded 0,1% per year of all herds for six consecutive years

and at least 99,9% of herds have achieved officially tuberculosis-free

status each year for six consecutive years, the calculation of this latter

percentage to take place on 31 December each calendar year;

(b) an identification system making it possible to identify the herds of

origin and transit for each bovine animal is in existence in accordance

with European Union Regulation (EC) No. 1760/2000;

(c) all bovine animals slaughtered are subjected to an official post-mortem

examination;

(d) the procedures for suspension and withdrawal of officially tuberculosis-

fiee status are complied with.

5. The Member State or part of a Member State will retain officially

tuberculosis-free status if the conditions 4(a) to (d) continue to be met. However, if

there is evidence of a significant change in the situation as regards tuberculosis in a

Member State or part of a Member State which has been recognised as officially

tuberculosis-free, the European Commission may, in accordance with the procedure

laid down in Article 17 of the European Union Council Directive 64/432/EEC, take a

Decision suspending or revoking the status until the requirements ofthe Decision

have been fulfilled.

Officially brucellosis-free and brucellosis-free bovine herds

For the purposes of this section "bovine animals" means all bovine animals with

the exception of males for fattening provided that they come from officially

brucellosis-free herds and that the competent authority guarantees that the males for

fattening will not be used for breeding and will go direct for slaughter.

1. A bovine herd is officially brucellosis-free if -

(a) it contains no bovine animals which have been vaccinated against

brucellosis, except females which have been vaccinated at least three

years previously;

(b) all the bovine animals have been free from clinical signs of brucellosis

for at least six months;

(c) all the bovine animals over twelve months old have been subjected to

one of the following test regimes with negative results in accordance

with Schedule C -

(i)

two serological tests specified in paragraph 10 at an interval of

more than three months and less than twelve months;

(ii) three tests on milk samples at three-monthly intervals followed at

least six weeks later by a serological test specified in paragraph

10;

(d) any bovine animal entering the herd comes from a herd of officially

brucellosis-free status and, in the case of bovine animals over twelve

months old, has shown a brucella titre of less than 30 IU of

agglutination per ml when given a serum agglutination test in

accordance with Schedule C or has reacted negatively to any other test

approved in accordance with the procedure at Article 17 during the

thirty days prior to or the thirty days after the date of its introduction

into the herd; in the latter case, the animal(s) must be isolated

physically from the other animals of the herd in such a way as to avoid

direct or indirect contact with the other animals until proven negative.

2. A bovine herd will retain officially brucellosis-free status if -

(a) one of the following test regimes is carried out annually with negative

results in accordance with Schedule C

(i)

three milk ring tests carried out at intervals of at least three

months;

(ii) three milk ELISAs carried out at intervals of at least three

months;

(iii) two milk ring tests carried out at an interval of at least three

months followed at least six weeks later by a serological test

referred to in paragraph 10;

(iv) two milk ELISAs carried out at an interval of at least three

months followed at least six weeks later by a serological test

referred to in paragraph 10;

(v) two serological tests carried out at an interval of at least three

months and not more than twelve months.

However, the competent authority of a Member State may, for the

Member State, or part of the Member State which is not officially

brucellosis-free but where all the bovine herds are subject to an official

programme to combat brucellosis, alter the frequency of the routine

tests as follows

-

where not more than 1% of bovine herds are infected, it may be

sufficient to carry out each year two milk ring tests or two milk

ELISAs at an interval of at least three months, or one serological

test,

-

where at least 99,8% of bovine herds have been recognised as

officially brucellosis-free for at least four years, the interval

between checks may be extended to two years if all animals over

twelve months of age are tested, or testing may be restricted to

animals over twenty-four months of age if herds continue to be

tested each year. The checks must be carried out using one of the

serological tests referred to in paragraph 10;

(b) all bovine animals entering the herd come from herds of officially

brucellosis-free status and, in the case of bovine animals over twelve

months old, have shown a brucella titre of less than 30 IU of

agglutination per ml when given a serum agglutination test in

accordance with Schedule C or have reacted negatively to any other test

approved in accordance with the procedure at Article 17 during the

thirty days prior to or the thirty days after the date of their introduction

into the herd; in the latter case, the animal(s) must be isolated

physically from the other animals of the herd in such a way as to avoid

direct or indirect contact with the other animals until proven negative.

However, the test described in point (b) need not be required in Member

States, or regions of Member States, where the percentage of bovine

herds infected with brucellosis has not exceeded 0,2% for at least two

years and where the animal comes from an officially brucellosis-free

bovine herd within that Member State or region and has not during

transportation come into contact with bovine animals of lesser status;

(c) notwithstanding point (b), bovine animals from a brucellosis-free

bovine herd may be introduced into an officially brucellosis-free herd if

they are at least eighteen months old and, if vaccinated against

brucellosis, the vaccination was carried out more than a year previously.

Such animals must have shown, in the thirty days prior to introduction,

a brucella titre lower than 30 IU of agglutination per ml and a negative

result when given a complement fixation test, or other test approved

under the procedure set out in Article 17 of the European Union Council

Directive 64/432/EEC.

If, however, a female bovine animal from a brucellosis-free herd is

introduced into an officially brucellosis-free herd, under the provisions

of the above paragraph, that herd shall be considered to be brucellosis-

free for two years from the date on which the last vaccinated animal was

introduced.

3A. The officially brucellosis-free status of a herd is to be suspended if -

(a) the conditions detailed in paragraphs 1 and 2 are no longer fulfilled; or

(b) as a result of laboratory tests or on clinical grounds one or more bovine

animals is suspected of having brucellosis and the suspect animals have

been slaughtered or isolated in a way to avoid any direct or indirect

contact with the other animals.

Where the animal has been slaughtered and is no longer available for testing, the

suspension may be lifted if two serum agglutination tests, carried out in accordance

with Schedule C on all bovine animals in the herd over twelve months old, show a

titre lower than 30 IU of agglutination per ml. The first test shall be carried out at

least thirty days after the removal of the animal and the second at least sixty days

later.

Where the animal has been isolated from the animals in the herd, it may be

reintroduced into the herd and the status of the herd may be restored following -

(a) a serum agglutination test which has shown a titre lower than 30 IU of

agglutination per ml and has given a negative result to a complement

fixation test, or

(b) a negative result to any other combination of tests approved for that

purpose under the procedure set out in Article 17 of the European Union

Council Directive 64/432/EEC.

3B. The officially brucellosis-free status of the herd is to be withdrawn if, as a

result of laboratory tests or epidemiological investigations, brucella infection has

been confirmed in the herd.

The status of the herd is not to be restored until either all bovine ammals present

in the herd at the time of the outbreak have been slaughtered, or the herd has been

subject to check testing and all animals over twelve months of age have given

negative results to two consecutive tests at sixty-day intervals, the first being carried

out not less than thirty days after removal of the positive animal(s).

In the case of bovine animals, which were pregnant at the time of the outbreak, the

final check must be carried out at least twenty-one days after the last animal

pregnant at the time of the outbreak has calved.

4. A bovine herd is brucellosis-free if it complies with the conditions in 1(b)

and (c) and when vaccination has been carried out as follows

(i)

female bovine animals have been vaccinated -

-

before the age of six months old with live strain 19 vaccine, or

-

before the age of fifteen months old with killed 45/20 adjuvant

vaccine which has been officially inspected and approved, or

-

with other vaccines approved under the procedure laid down in

Article 17 of the European Union Council Directive 64/432/EEC;

(ii) bovine animals under thirty months old which have been vaccinated

with live strain 19 vaccine may give a serum agglutination test result

greater than 30 IU but less than 80 IU of agglutination per millilitre

provided that, on the complement fixation test, they give a result less

than 30 EEC units in the case of females vaccinated less than twelve

months previously or less than 20 EEC units in all other cases.

5. A bovine herd will retain brucellosis-free status if -

(i)

it is subject to one of the testing regimes listed in 2(a);

(ii) bovine animals entering the herd comply with the requirements of 2(b);

or

-

come from herds of brucellosis-free status, and in the case of

bovine animals over twelve months old, have shown, in the thirty

days prior to or in isolation after introduction into the herd, less

than 30 IU of agglutination per ml when given a serum

agglutination test and a negative result to a complement fixation

test in accordance with Schedule C, or

-

come from herds of brucellosis-free status, are under thirty

months old and have been vaccinated with live strain 19 vaccine

if they give a serum agglutination test result greater than 30 IU

but less than 80 IU of agglutination per millilitre provided that,

on the complement fixation test, they give a result less than 30

EEC units in the case of females vaccinated less than twelve

months previously or less than 20 EEC units in all other cases.

6A. The brucellosis-free status of a herd is to be suspended if -

(a) the conditions detailed in paragraphs 4 and 5 have not been complied

with; or

(b) as a result of laboratory tests or on clinical grounds one or more bovine

animals over thirty months old is suspected of having brucellosis and

the animal(s) under suspicion have been slaughtered, or isolated in a

way to avoid any direct or indirect contact with other animals. Where

the animal has been isolated, it may be reintroduced into the herd and

the status of the herd may be restored, if it subsequently shows a serum

agglutination titre lower than 30 IU of agglutination per ml and has

given a negative result to a complement fixation test, or other test

approved under the procedure set out in Article 17 of the European

Union Council Directive 64/432/EEC.

Where the animals have been slaughtered and are no longer available for testing,

the suspension may be lifted if two serum agglutination tests, carried out in

accordance with Schedule C on all bovine animals in the holding over twelve months

old, show a titre lower than 30 IU of agglutination per ml. The first test is to be

carried out at least thirty days after the removal of the animal and the second at least

sixty days later.

If the animals to be tested in the previous two subparagraphs are under thirty

months old and have been vaccinated with live strain 19 vaccine they may be

considered to be negative if they give a serum agglutination test result greater than

30 IU but less than 80 IU of agglutination per millilitre provided that, on the

complement fixation test, they give a result less than 30 EEC units in the case of

females vaccinated less than twelve months previously or less than 20 EEC units in

all other cases.

6B. The brucellosis-free status of the herd is to be withdrawn if, as a result of

laboratory tests of epidemioloaical investigations, brucella infection has been

confirmed in a herd. The status of the herd is not to be restored until either all the

bovine animals present in the herd at the time of the outbreak have been slaughtered

or the herd has been subject to check testing and all unvaccinated animals over

twelve months of age have given negative results to two consecutive tests at sixty-

day intervals, the first being carried out not less than thirty days after removal of the

positive animal(s).

If all the animals to be tested referred to in the preceding paragraph are less than

thirty months old and have been vaccinated with live strain 19 vaccine, they may be

considered negative if they show a brucella titre of more than 30 IU but less than 80

IU of agglutination per ml, provided that in the complement fixation test they show a

titre of less than 30 EEC units in the case of females vaccinated less than twelve

months previously or a titre of less than 20 EEC units in all other cases.

In the case of bovine animals which were pregnant at the time of the outbreak, the

final check must have been carried out at least twenty-one days after the last animal

pregnant at the time of the outbreak has calved.

7. A Member State or a region of a Member State may be declared officially

brucellosis-free according to the procedure laid down in Article 17 of the European

Union Council Directive 64/432/EEC if it meets the following conditions

(a) no case of abortion due to brucella infection and no isolation of B.

abortus has been recorded for at least three years and at least 99,8% of

herds have achieved officially brucellosis-free status each year for five

consecutive years, the calculation of this percentage to take place on 31

December each calendar year. However, where the competent authority

adopts a policy of whole herd slaughter, isolated incidents shown by

epidemiological enquiry to be due to the introduction of animals from

outside the Member State or part of the Member State and herds whose

officially brucellosis-free status has been suspended or withdrawn for

reasons other than suspicion of disease, is to be disregarded for the

purpose of the above calculation provided that the central competent

authority of the Member State concerned by these incidents makes an

annual record and forwards them to the European Commission in

accordance with regulation 8(2), and

(b) an identification system making it possible to identify the herds of

origin and transit for each bovine animal is in existence in accordance

with European Union Regulation (EC) No. 820/97, and

(c) notification of cases of abortion is mandatory and they are investigated

by the competent authority.

8. Subject to paragraph 9, a Member State or a region of a Member State

declared officially brucellosis free is to retain this status if -

(a) the conditions imposed by paragraph 7(a) and (b) are still fulfilled and

notification of cases of abortion suspected of being due to brucellosis is

mandatory and are investigated by the competent authority;

(b) every year for the first five years after attaining status, all bovine

animals over twenty-four months of age in not less than 20% of herds

have been tested and have reacted negatively to a serological test

carried out in accordance with Schedule C or, in the case of dairy herds,

by examination of milk samples in accordance with Schedule C;

(c) every bovine animal suspected of being infected with brucellosis is

notified to the competent authority and undergoes official

epidemiological investigation for brucellosis comprising at least two

serological blood tests, including the complement fixation test, and a

microbioloþical examination of appropriate samples;

(d) during the period of suspicion, which is to continue until negative

results have been obtained from the tests provided for in (c), the

officially brucellosis-free status of the herd of origin or transit of the

suspected bovine animal and of the herds linked epidemiologically to it

is to be suspended;

(e) in the event of an outbreak of brucellosis that has spread, all bovine

animals have been slaughtered. Animals of the remaining susceptible

species will undergo appropriate tests and premises and equipment will

be cleaned and disinfected.

A Member State or a region of a Member State declared officially brucellosis-free

is to report the occurrence of all cases of brucellosis to the European Commission. If

there is evidence of a significant change in the situation as regards brucellosis in a

Member State or part of a Member State which has been recognised as officially

brucellosis-free, the European Commission may according to the procedure laid

down in Article 17 of the European Union Council Directive 64/432/EEC propose

that the status be suspended or revoked until the requirements of the Decision have

been fulfilled.

10. For the purposes of section II, a serological test means either a serum

agglutination test, buffered brucella antigen test, complement fixation test, plasma

agglutination test, plasma ring test, micro-agglutination test or individual blood

ELISA, as described in Schedule C. Any other diagnostic test approved under the

procedure laid down in in Article 17 of the European Union Council Directive 64/

432/EEC and described in Schedule C will also be accepted for the purposes of

section II. A milk test means a milk ring test or a milk ELISA in accordance with

Schedule C.

(1) Only animals that fulfil the relevant conditions laid

downin these regulations may be moved from the place of birth.

(2) Bovine animals and swine covered by these regulations

must -

(a) be subjected -

(i) to an identity check, and

(ii) to a clinical inspection within twenty-four hours

of departure by an official veterinarian and show

no clinical sign of disease;

(b) not have been obtained from a holding or an area

which for health reasons is subject to prohibition or

restriction affecting the species involved in accordance

with Community and or national legislation;

(c) be identified as provided for in European Union

Council Directive 92/102/EEC;

(d) not be animals which are to be slaughtered and not be

restricted under a contagious or infectious disease

eradication programme in Malta;

(e) comply with the provisions of regulations 4 and 5.

Amended by

L.N. 269 of 2010.

TUBERCULOSIS

IDENTIFICATION OF THE AGENT

The presence of Mycobacterium bovis (M. bovis), agent of bovine tuberculosis, in

clinical and post-mortem specimens may be demonstrated by examination of stained

smears or immunoperoxidase techniques and confirmed by cultivation of the

organism on primary isolation medium.

Pathological material for the confirmation of M. bovis should be taken from

abnormal lymph nodes and parenchymatous organs such as lungs, liver, spleen, etc.

In the cases where the animal does not present pathological lesions, samples from

the retropharyngeal, bronchial, mediastinal, supramammary, mandibular and some

mesenteric lymph nodes and liver should be collected for examination and culture.

Identification of isolates may be usually carried out by determining cultural and

biochemical properties. The polymerase chain reaction (PCR) may also be employed

for the detection of the M tuberculosis complex. DNA analysis techniques may prove

to be faster and more reliable than biochemical methods for the differentiation of M.

bovis from other members of the M. tuberculosis complex. Genetic fingerprinting

allows distinguishing between different strains of M bovis and will enable patterns of

origin, transmission and spread of M. bovis to be described.

The techniques and media used, their standardisation and the interpretation of

results must conform to that specified in the OIE Manual of Standards for Diagnostic

Tests and Vaccines, Fourth Edition, 2000, Chapter 2.3.3 (bovine tuberculosis).

2. THE TUBERCULIN SKIN TEST

Tuberculin PPD (Purified Protein Derivatives) that fulfil the standards laid down

in paragraph 2.1 shall be used for carryine out official tuberculin skin test following

the procedures referred to in paragraph 2.2.

2.1. Standards for tuberculin (bovine and avian)

2.1.1. Definition

Tuberculin purified protein derivative (tuberculin PPD, bovine or avian) is a

preparation obtained from the heat-treated products of growth and lysis of

Mycobacterium bovis or Mycobacterium avium (as appropiate) capable of revealing

a delayed hypersensitivity in an animal sensitised to microorganisms of the same

species.

2.1.2. Production

It is obtained from the water-soluble fractions prepared by heating in free-flowing

steam and subsequently filtering cultures of M. bovis or M. avium (as appropiate)

grown in a liquid synthetic medium. The active fraction of the filtrate, consisting

mainly of protein, is isolated by precipitation, washed and re-dissolved. An

antimicrobial preservative that does not give rise to false positive reactions, such as

phenol, may be added. The final sterile preparation, free from mycobacteria, is

distributed aseptically into sterile tamper-proof glass containers which are then

closed so as to prevent contamination. The preparation may be freeze-dried.

2.1.3. Identification of the product

Inject a range of graded doses intradermally at different sites into suitably

sensitised albino guinea-pigs, each weighing not less than 250 g. After 24 h to 28 h,

reactions appear in the form of oedematous swellings with erythema with or without

necrosis at the points of injection. The size and severity of the reactions vary

according to the dose. Unsensitised guinea-pigs show no reactions to similar

injections.

2.1.4. Tests

2.1.4.1. pH: The pH is 6.5 to 7.5.

2.1.4.2. Phenol: If the preparation to be examined contains phenol, its

concentration is not more than 5 g/1.

2.1.4.3. Sensitising effect: Use a group of three guinea-pigs that have not

been treated with any material which will interfere with the test. On

three occasions at intervals of five days inject intradermally into

each guinea-pig a dose of the preparation to be examined equivalent

to 500 IU in 0,1 ml. Fifteen to twenty-one days after the third

injection inject the same dose (500 IU) intradermally into these

animals and into a control group of three guinea-pigs of the same

mass and which have not previously received injections of

tuberculin. 24 to 28 hours after the last injections, the reactions of

the two groups are not significantly different.

2.1.4.4. Toxicity: Use two guinea-pigs, each weighing not less than 250 g

and which have not previously been treated with any material which

will interfere with the test. Inject subcutaneously into each guinea-

pig 0,5 ml of the preparation to be examined. Observe the animals

for seven days. No abnormal effects occur during the observation

period.

2.1.4.5. Sterility: It complies with the test for sterility prescribed in the

monograph on Vaccines for veterinary use 4th Edition 2002 of the

European Pharmacopoeia.

2.1.5. Potency

The potency of tuberculin purified protein derivative (bovine and avian) is

determined by comparing the reactions produced in sensitised guinea-pigs by the

intradermal injection of a series of dilutions of the preparation to be examined with

those produced by known concentrations of a reference preparation of tuberculin

(bovine or avian, as appropiate) purified protein derivative calibrated in

international Units.

To test the potency, sensitise not fewer than nine albino guinea-pigs, each

weighing 400 g to 600 g, by the deep intramuscular injection of 0,0001 ms of wet

mass of living M. bovis of strain AN5 suspended in 0.5 ml of a 9 g/l solution of

sodium chloride R for bovine tuberculin, or a suitable dose of inactivated or live M.

avium for avian tuberculin. Not less than four weeks after the sensitisation of the

guinea-pigs, shave their flanks to provide space for not more than four injection sites

on each side. Prepare dilutions of the preparation to be examined and of the

reference preparation using isotonic phosphate-buffered saline (pH 6,5-7,5)

containing 0 005 g/1 of polysorbate 80 R. Use not fewer than three doses of the

reference preparation and not fewer than three doses of the preparation to be

examined. Choose the doses such that the lesions produced have a diameter of not

less than 8 mm and not more than 25 mm. Allocate the dilutions randomly to the

sites using a Latin square design. Inject each dose intradermally in a constant

volume of 0,1 ml or 0,2 ml. Measure the diameters of the lesions after 24 to 28 hours

and calculate the result of the test using the usual statistical methods and assuming

that the diameters of the lesions are directly proportional to the logarithm of the

concentration of the tuberculins.

The test is not valid unless the fiducial limits of error (P = 0,95) are not less than

50% and not more then 200% of the estimated potency. The estimated potency is not

less than 66% and not more than 150% of the stated potency for bovine tuberculin.

The estimated potency is not less than 75% and not more than 133% of the stated

potency for avian tuberculin. The stated potency is not less than 20 000 IU/ml for

both tuberculins (bovine and avian).

2.1.6. Storage

Store protected from light, at a temperature of 5 ± 3°C.

2.1.7. Labelling

The label states -

-

the potency in Intemational Units per millilitre,

-

the name and quantity of any added substance,

-

for freeze-dried preparations

(a) the name and volume ofthe reconstituting liquid to be added,

(b) that the product should be used immediately after reconstitution.

2.2. Test procedures

2.2.1. The following shall be recognised as official intra-dermal tuberculin tests -

-

the single intradermal test: this test requires a single injection of bovine

tuberculin,

-

the intradermal comparative test: this test requires one injection of

bovine tuberculin and one injection of avian tuberculin given

simultaneously.

2.2.2. The dose of tuberculin injected shall be -

-

not less than 2 000 IU of bovine tuberculin,

-

not less than 2 000 IU of avian tuberculin.

2.2.3. The volume of each injection dose shall not exceed 0,2 ml.

2.2.4. Tuberculin tests shall be carried out by injecting tuberculin(s) jnto the skin

of the neck. The injection sites shall be situated at the back of the anterior and

middle thirds of the neck. When both avian and bovine tuberculins are injected in the

same animal, the site for injection of avian tuberculins shall be about 10 cm from the

crest of the neck and the site for the injection of bovine tuberculin about 12,5 cm

lower on a line roughly parallel with the line of the shoulder or on different sides of

the neck; in young animals in which there is not room to separate the sites

sufficiently on one side of the neck, one injection shall be made on each side of the

neck at identical sites in the centre of the middle third of the neck.

2.2.5. The technique of tuberculin testing and interpretation of reactions shall be

2.2.5.1. Technique -

Injection sites shall be clipped and cleansed. A fold of skin within

each clipped area shall be taken between the forefinger and thumb

and measured with callipers and recorded. The dose of tuberculin

shall then be injected by a method that ensures that the tuberculin is

delivered intradermically. A short sterile needle, bevel edge

outwards, with graduated syringe charged with tuberculin, inserted

obliquely into the deeper layers of the skin may be used. A correct

injection shall be confirmed by palpating a small pea-like swelling

at each site of injection. The skin-fold thickness of each injection

site shall be remeasured seventy-two hours (± four hours) after

injection and recorded.

2.2.5.2. Interpretation of reactions

The interpretation of reactions shall be based on clinical

observations and the recorded increase(s) in skin-fold thickness at

the sites of injection seventy-two hours after injection of

tuberculin(s).

(a) Negative reaction: if only limited swelling is observed, with an

increase of not more than 2 mm in the thickness of the fold of

skin without clinical signs such as diffuse or extensive oedema,

exudation, necrosis, pain or inflammation of the lymphatic

ducts in that region or of the lymph nodes.

(b) Inconclusive reaction: if no clinical signs such as mentioned in

(a) are observed and if the increase in skin-fold thickness is

more than 2 mm and less than 4 mm.

(c) Positive reaction: if clinical signs such as mentioned in (a) are

observed or there is an increase of 4 mm or more in the

thickness of the fold of skin at the injection site.

2.2.5.3. The interpretation of official intradermal tuberculin tests shall be as

follows

2.2.5.3.1.

Single intradermal test -

(a) positive: a positive bovine reaction as defined in

paragraph 2.2.5.2(c);

(b) inconclusive: an inconclusive reaction as defined

in paragraph 2.2.5.2(b);

(c) negative: a negative bovine reaction as defined in

paragraph 2.2.5.2(a).

Animals inconclusive to the single intradermal test shall

be subjected to another test after a minimum of forty-

two days.

Animals which are not negative to this second test shall

be deemed to be positive to the test.

Animals positive to the single intradermal test may be

subjected to an intradermal comparative test if false

positive reaction or interference reaction is suspected.

2.2.5.3.2.

Intradermal comparative test for the establishment and

maintenance of officially tuberculosis-free herd status -

(a) positive: a positive bovine reaction which is more

than 4 mm greater than the avian reaction, or the

presence of clinical signs;

(b) inconclusive: a positive or inconclusive bovine

reaction which is from 1 to 4 mm greater than the

avian reaction, and the absence of clinical signs;

(c) negative: a negative bovine reaction, or a positive

or inconclusive bovine reaction but which is equal

to or less than a positive or inconclusive avian

reaction and the absence of clinical signs in both

cases.

Animals inconclusive to the intradermal comparative

test shall be subjected to another test after a minimum of

forty-two days. Animals, which are not negative to this

second test, shall be deemed to be positive to the test.

2.2.5.3.3.

Officially tuberculosis-free herd status may be

suspended and animals from the herd shall not be

allowed to enter intra-Community trade until such time

as the status of the following animals is resolved -

(a) animals which have been deemed to be

inconclusive to the single intradermal tuberculin

test;

(b) animals which haae been deemed to be positive to

the single intradermal tuberculin test but are

awaiting retest with an intradermal comparative

test;

(c) animals which have been deemed to be

inconclusive to the intradermal comparative test.

2.2.5.3.4.

Where animals are required by European Community

legislation to be subjected to an intradermal test prior to

movement, the test shall be interpreted so that no animal

which shows an increase in skin-fold thickness greater

than 2 mm or the presence of clinical signs is entered

into Intra-Community trade.

2.2.5.3.5.

To enable detection of the maximum number of infected

and diseased animals in a herd or in a region, Member

States may modify the criteria for the interpretation of

the test in to achieve improved test sensitivity

considering all inconclusive reactions referred in

2.2.5.3.1(b) and 2.2.5.3.2(b) as positive reactions.

SUPPLEMENTARY TESTING

To enable detection of the maximum number of infected and diseased animals in a

herd or in a region, Member States may authorise the employ of the gamma-

interferon assay referred in the OIE Manual of Standards for Diagnostic Tests and

Vaccines, 4th Edition. 2000, Chapter 2.3.3. (bovine tuberculosis), in addition to the

tuberculin test.

STATE INSTITUTES AND NATIONAL REFERENCE LABORATORIES

4.1. Tasks and responsibilities

Institutes, national reference laboratories or official institutes designated by the

competent authority in accordance with rule 6A shall be responsible for the official

testing of tuberculins or reagents referred to in paragraphs 2 and 3 respectively in

Malta to ensure that each of these tuberculins or reagents is adequate in relation to

the standards referred to in point 2.1 and paragraph 3 respectively.

(1) Bovine animals and swine covered by these regulations

must at no time between leaving the holding of origin and arriving

at destination come into contact with cloven-hoofed animals other

than animals that have the same health status.

(2) Bovine animals and swine covered by these regulations

must be transported by means of transport meeting the

requirements of European Union Council Directive 91/628/EEC

and in addition the requirements of regulation 12.

(3) Rules for the approval of sites where cleansing and

disinfection may be carried out shall be determined in accordance

with the procedure set out in Article 17 of the European Union

Council Directive 64/432/EEC.

Amended by

L.N. 269 of 2010.

BRUCELLOSIS

1. IDENTIFICATION OF THE AGENT

The demonstration by modified acid-fast or immunospecific staining of organisms

of Brucella morphology in abortion material, vaginal discharges or milk provides

presurnptive evidence of brucellosis, especially if supported by serological tests.

After isolation, the species and biovar should be identified by phage lysis and, or

oxidative metabolism tests, cultural, biochemical and serological criteria.

The techniques and media used, their standardisation and the interpretation of

results must conform to that specified in the CIE Manual of Standards for Diagnostic

Tests and Vaccines, Fourth Edition, 2000, Chapter 2.3.1 (bovine brucellosis),

C h a pt e r 2 . 4 . 2 ( c a pr i n e an d ov i n e b r u c e l l o s i s ) a n d C h a p t e r 2 . 6 . 2 ( p o r c i n e

brucellosis).

2. IMMUNOLOGICAL TESTS

2.1. Standards

2.1.1. The Brucella abortus biovar 1 Weybridge strain No 99 or USDA strain

1119-3 must be used for the preparation of all antigens used in the rose bengal test

(RBT), serum agglutination test (SAT), complement fixation test (CFT) and the milk

ring test (MRT).

2.1.2. The standard reference serum for the RBT, SAT, CFT and MRT is the OIE

international reference standard serum (OIEISS) formerly named WHO second

international anti-Brucella abortus Serum (ISAbS).

2.1.3. The standard reference sera for ELISAs are -

-

the OIEISS,

-

the weak positive OIE ELISA standard serum (OIEELISA WP SS),

-

the strong positive OIE ELISA standard serum (OIEELISA SP SS),

-

the negative OIE ELISA standard serum (OIEELISA N SS).

2.1.4. The above listed standard sera are available from the Veterinary

Laboratories Agency (VLA), Weybridge, United Kingdom.

2.1.5. The OIEISS, the OIEELISA H , P SS, the OIEELISA,,SS and the

OIEELISA N SS are international primary standards from which secondary reference

national standards ("working standards") must be established for each test in each

2.2. Enryme-linked immunosorbent assays (ELISAs) or other binding assays for

the detection of bovine brucellosis in serum or milk

2.2.1. Material and reagents

The technique used and the interpretation of results must have been validated in

accordance with the principles laid down in Chapter 1.1.3 of the CIE Manual of

Standards for Diagnostic Tests and Vaccines, Fourth Edition, 2000, and should at

least include laboratory and diagnostic studies.

2.2.2. Standardisation of the test

2.2.2.1. Standardisation of the test procedure for individual serum samples -

(a) a 1/150 pre-dilution ( * ) of the OIEISS or a 1/2 pre-dilution of

the OIEELISA, SS or a 1/16 pre-dilution of the OIEELISA,,SS

made up in a negative serum (or in a negative pool of sera)

should give a positive reaction;

(b) a 1/600 pre-dilution of the OIEISS or a 1/8 pre-dilution of the

OIEELISA,,SS or a 1/64 pre-dilution of the OIEELISA,,SS

made up in a negative serum (or in a negative pool of sera)

should give a negative reaction;

(c) the OIEELISA N SS should always give a negative reaction.

2.2.2.2. Standardisation of the test procedure for pooled serum samples -

(a) a 1/150 pre-dilution of the MISS or a 1/2 pre-dilution of the

OIEELISA Wp SS or a 1/16 pre-dilution of the OIEELISA sr SS

made up in a negative serum (or in a negative pool of sera) and

again diluted in negative sera by the number of samples making

up the pool should give a positive reaction;

(b) the OIEELISA N SS should always give a negative reaction;

(c) the test must be adequate to detect evidence of infection in a

single animal of the group of animals, of which samples of

serum have been pooled.

2.2.2.3. Standardisation of the test procedure for pooled milk or whey

samples -

(a) a 1/1000 pre-dilution of the OIEISS or a 1/16 pre-dilution of the

OIEELISA. SS or a 1/125 pre-dilution of the OIEELISAS SS

made up in a negative serum (or in a negative pool of sera) and

again diluted 1/10 in negative milk should give a positive

reaction;

(b) the OIEELISA N SS diluted 1/10 in negative milk should always

give a negative reaction;

(c) the test must be adequate to detect evidence of infection in a

single animal of the group of animals, of which samples of milk

or whey have been pooled.

2.2.3. Conditions for use of the ELISAs for diagnosis of bovine brucellosis -

*For the purpose of this Schedule, dilutions given for making up liquid reagents are expressed as, for

example, 1 150 shall mean a 1 in 150 dilution.

2.2.3.1. Using the abovementioned calibrating conditions for ELISAs on

serum samples, the diagnostic sensitivity of ELISA shall be equal or

greater than the RBT or CFT taking into account the

epidemiological situation under which it is employed.

2.2.3.2. Using the abovementioned calibrating conditions for ELISA on

pooled milk samples, the diagnostic sensitivity of ELISA shall be

equal or greater than the MRT taking into account not only the

epidemiological situation but also the average and expected extreme

husbandry systems.

2.2.3.3. Where ELISAs are used for certification purposes in accordance

with regulation 6(1) or for the establishment and maintenance of a

herd status in accordance with Schedule A(II)(10), pooling of

samples of serum must be carried out in such a way that the test

results can be undoubtedly related to the individual animal included

in the pool. Any confirmatory test must be carried out on samples of

serum taken from individual animals.

2.2.3.4. The ELISAs may be used on a sample of milk taken from the milk

collected from a farm with at least 30% of dairy cows in milk. If this

method is used, measures must be taken to ensure that the samples

taken for examination can be undoubtedly related to the individual

animals from which the milk derived. Any confirmatory test must

be carried out on samples of serum taken from individual animals.

2.3. Complement fixation test (CFT)

2.3.1. The antigen represents a bacterial suspension in phenol-saline (NaCI 0,85%

(m/v) and phenol at 0,5% (v/v)) or in a veronal buffer. Antigens may be delivered in

the concentrated state provided the dilution factor to be used is indicated on the

bottle label. The antigen must be stored at 4°C and not frozen.

2.3.2. Serums must be inactivated as follows

bovine serum: 56 to 60°C for 30 to 50 minutes,

porcine serum: 60°C for 30 to 50 minutes.

2.3.3. In to carry out the genuine reaction within the test procedure, a complement

dose higher than the minimum necessary for total haemolysis should be used.

2.3.4. In carrying out the complement fixation test, the following controls must be

made each time -

(a) control of the anti-complementary effect of the serum;

(b) control of the antigen;

(c) control of sensitised red blood cells;

(d) control of the complement;

(e) control using a positive serum of sensitivity at the start of the reaction;

(f)

control of the specificity of the reaction using a negative serum.

2.3.5. Calculation of results

The OIEISS contains 1 000 international CFT units (ICFTU) per ml. If the OIEISS

is tested in a given method the result is given as a titre ( TOIEISS ). The test result for

the test serum given as titre ( TTESTSERUM ) must be expressed in ICFTU per ml. In

order to convert the expression of a titre into ICFTU, the factor (F) necessary to

convert a titre of an unknown test serum ( TTESTSERUM ), tested by that method into

the ICFTLJ expression can be found from the formula -

F = 1 000 x 1 /T OIEISS

and the content of international CFT units per ml of test serum ( ICFTU, ESTSERUM )

from the formula -

ICFFU TESTSERU = F x T TESTSERUM

2.3.6. Interpretation of results

A serum containing 20 or more ICFTU per ml is considered to be positive.

2.4. Milk ring test (MRT)

2.4.1. The antigen represents a bacterial suspension in phenol-saline (NaCI 0,85%

(m/v) and phenol at 0,5% (v/v)) stained with haematoxylin. The antigen must be

stored at 4°C and not frozen.

2.4.2. The antigen sensitivity must be standardised in relation to the OIEISS in

such a way that the antigen produces a positive reaction with a 1/500 dilution of the

OIEISS in negative milk, while a 1/1 000 dilution should be negative.

2.4.3. The ring test must be made on samples representing the contents of each

milk chum or the content of each bulk tank from the farm.

2.4.4. The milk samples must not have been frozen, heated or subjected to violent

shaking.

2.4.5. The reaction must be carried out using one of the following methods -

-

on a column of milk of at least 25 mm height and on a volume of milk of

1 ml to which either 0,03 ml or 0,05 ml of one of the standardised

stained antigens has been added,

-

on a column of milk of at least 25 mm height and on a volume of milk of

2 ml to which 0,05 ml of one of the standardised stained antigens has

been added,

-

on a volume of milk of 8 ml to which 0,08 ml of one of the standardised

stained antigens has been added.

2.4.6. The mixture of milk and antigens must be incubated at 37°C for sixty

minutes, together with positive and negative working standards. A subsequent 16 to

24 hour incubation at 4°C increases the sensitivity of the test.

2.4.7. Interpretation of results -

(a) negative reaction: coloured milk, colourless cream;

(b) positive reaction -

-

identically coloured milk and cream, or

-

colourless milk and coloured cream.

2.5. Rose bengal plate Test (RBT)

2.5.1. The antigen represents a bacterial suspension in buffered Brucella antigen

diluent at a pH of 3,65 i 0 05, stained by the use of rose bengal dye. The antigen shall

be delivered ready for use and must be stored at 4°C and not frozen.

2.5.2. The antigen shall be prepared without reference to the cell concentration,

but its sensitivity must be standardised in relation to the OIEISS in such a way that

the antigen produces a positive reaction with a serum dilution of 1/45 and a negative

reaction with a dilution of 1/55.

2.5.3. The RBT shall be carried out in the following manner

(a) serum (20-30 pd) is mixed with an equal volume of antigen on a white

tile or enamel plate to produce a zone approximately 2 cm in diameter.

The mixture is rocked gently for 4 minutes at ambient temperature, and

then observed in a good light for agglutination;

(b) an automated method may be used but must be at least as sensitive and

accurate as the manual method.

2.5.4. Interpretation of results

Any visible reaction is considered to be positive, unless there has been excessive

drying round the edges. Positive and negative working standards should be included

in each series oftests.

2.6. Serum agglutination test (SAT)

2.6.1. The antigen represents a bacterial suspension in phenol-saline (NaC1 0,85%

(m/v) and phenol at 0,5% (v/v)). Formaldehyde must not be used.

Antigens may be delivered in the concentrated state provided the dilution factor to

be used is indicated on the bottle label.

EDTA may be added to the antigen suspension to 5 mM final test dilution to

reduce the level of false positives to the serum agglutination test. Subsequently the

pH of 7,2 must be readjusted in the antigen suspension.

2.6.2. The OIEISS contains 1 000 international units of agglutination.

2.6.3. The antigen shall be prepared without reference to the cell concentration,

but its sensitivity must be standardised in relation to the OIEISS in such a way that

the antigen produces either a 50% agglutination with a final serum dilution of 1/600

to 1/1 000 or a 75% agglutination with a final serum dilution of 1/500 to 1/750.

It may also be advisable to compare the reactivity of new and previously

standardised batches of antigen using a panel of defined sera.

2.6.4. The test is performed either in tubes or in microplates. The mixture of

antigen and serum dilutions should be incubated for 16 to 24 hours at 37°C.

At least three dilutions must be prepared for each serum. Dilutions of suspect

serum must be made in such a way that the reading of the reaction at the positivity

limit is made in the median tube (or well for the microplate method).

2.6.5. Interpretation of results

The degree of Brucella agglutination in a serum must be expressed in IU per ml. A

serum containing 30 or more IU per ml is considered to be positive.

3. COMPLEMENTARY TESTS

3.1. Brucellosis skin test (BST)

3.1.1. Conditions for the use of BST

(a) The brucellosis skin test shall not be used for the purpose of

certification for Intra-Community trade.

(b) The brucellosis skin test is one of the most specific tests for the

detection of brucellosis in unvaccinated animals, however diagnosis

should not be made on the basis of positive intradermal reactions alone.

(c) Bovine animals, tested with negative result in one of the serological

tests defined in this Annex and reacting positively to the BST shall be

regarded as infected.

(d) Bovine animals, tested with positive result in one of the serological tests

defined in this Annex may be subject to a BST in to support the

interpretation of the serological test results in particular where in

brucellosis free or officially free herds a cross-reaction with antibodies

against other bacteria cannot be excluded.

3.1.2. The test must be carried out by use of a standardised and defined brucellosis

allergen preparation that does not contain smooth lipopolysaccharide (LPS) antigen,

as this may provoke non-specific inflammatory reactions or interfere with

subsequent serological tests.

One of such preparation is Brucellin INRA prepared from a non-smooth strain of

B. melitensis. The requirements for its production are detailed in Section B2 of

Chapter 2.4.2. of the OIE Manual of Standards for Diagnostic Tests and Vaccines,

Fourth Edition, 2000.

3.1.3. Test procedure

3.1.3.1. A volume of 0,1 ml of brucellosis allergen is injected intradermally

into the caudal fold, the skin of the flank, or the side of the neck.

3.1.3.2. The test is read after 48-72 hours.

3.1.3.3. The skin thickness at the injection site is measured with vemier

callipers before injection and at re-examination.

3.1.3.4. Interpretation of results -

Strong reactions are easily recoþnised by local swelling and

induration.

Skin thickening of 1,5 to 2 mm shall be considered as positive

reaction to the BST.

3.2. Competitive enzyme-linked immunosorbent assay (cELISA)

3.2.1. Conditions fon the use of cELISA

(a) The cELISA shall not be used for the purpose of certification for intra-

Community trade.

(b) The cELISA has shown to have a higher specificity than for example the

indirect ELISA and may therefore be used in to support the

interpretation of the serological test results.

3.2.2. Test pnocedure

The test shall be carried out in accordance with the prescription in the CIE Manual

of Standards for Diagnostic Tests and Vaccines, Fourth Edition, 2000, Chapter 2.3.1

(2)(a).

4. NATIONAL REFERENCE LABORATORIES

4.1. Tasks and responsibilities

National Reference Laboratories designated by the competent authority in

accordance with rule 6A shall be responsible for

(a) the approval of the results of the validation studies demonstrating the

reliability of the test method used in the Member State;

(b) determination of the maximum number of samples to be pooled in

ELISA kits used;

(c) calibration of the standard secondary reference national standard sera

(''working standards'') against the primary international standard serum

referred to in paragraph 2.1;

(d) quality checks of all antigens and ELISA kits batches used in the

Member State;

(e) cooperation within the European Union Network of National Reference

Laboratories for Brucellosis.

(1) Bovine animals and swine covered by these regulations

must be accompanied during transportation to destination by a

health certificate conforming to the model 1 or 2 set out in Annex F

as appropriate. The certificate shall consist of a single sheet or,

where more than one page is required, shall be in such a form that

any two or more pages are part of an integrated who le and

indivisible and shall contain a serial number. It shall be drawn up

on the day of the health inspection, in one of the official languages

of the country of destination at least. The certificate shall be valid

for ten days from the date of the health examination.

(2) The health inspection for the issuing of the health

certificate (including additional guarantees) for a consignment of

animals may be carried out in the holding of origin or of an

assembly centre. For this purpose the Veterinary Services shall

ensure that any certificate is drawn up by the official veterinarian

a f t er i n s p e c t i o n s , v i s i t s a n d c o n t r o l s a s p r o v i d e d b y t h e s e

regulations. However as regards -

(a) animals coming from approved assembly centres such

certification shall be -

(i)

on the basis of an official document containing

the necessary information completed by the

official veterinarian for the holding of origin, or

(ii) in the form of the certificate according to either

model 1 or 2 in Annex F as appropriate with

Sections A and B duly completed and certified

by the official veterinarian for the holding of

origin;

(b) animals coming from an approved holding which is

participating in the surveillance network provided for

in regulation 14, such certification shall be -

(i)

on the basis of an official document containing

the necessary information completed by the

approved veterinarian for the holding of origin,

or

(ii) in the form of the certificate according to either

model 1 or 2 in Annex F as appropriate with

Sections A and B duly completed and certified

by the approved veterinarian for the holding of

origin. For this purpose, the official veterinarian

will ensure where appropriate that the additional

guarantees provided for in Community

legislation are fulfilled.

(3) The official veterinarian for the assembly centre shall carry

out all necessary checks on animals arriving there.

(4) The official veterinarian completing Section C of the

c e r t i f i c a t e a c c o r d i ng t o ei t h e r m o d e l 1 o r 2 i n A n n e x F a s

appropriate, shall ensure that the movement is registered on the

Animo system on the day the certificate is issued.

(5) The animals covered by these regulations may transit

through an assembly centre which is located in one other Member

State before being consigned to the Member State of destination. In

this case, the certificate according to either model 1 or 2 in Annex

F as appropriate (including Section C) must be completed by the

official veterinarian responsible in the Member states where the

animals originate. The official veterinary responsible for the

assembly centre of transit shall provide certification to the member

state of destination by completing a second certificate according to

either model 1 or 2 in Annex F as appropriate, endorsing it with the

serial number of the original attaching it to the original certificate

or to an officially endorsed copy thereof. In this case the combined

validity of the certificates shall not exceed that provided for in

subregulation (1).

Amended by

L.N. 269 of 2010.

CHAPTER I

OFFICIALLY ENZOOTIC-BOVINE-LEUKOSIS-FREE HERDS, MEMBER

STATES AND REGIONS

Officially enzootic-bovine-leukosis-free herd means a herd in which -

(i)

there is no evidence, either clinical or as a result of a laboratory test, of

any case of enzootic bovine leukosis in the herd and no such case has

been confirmed in the previous two years; and

(ii) all animals over twenty-four months of age have reacted negatively

during the preceding twelve months to two tests carried out in

accordance with this Annex, at an interval of at least four months; or

(iii) it meets the requirements of (i) above and is situated in an officially

enzootic-bovine-leukosis-free Member State or region.

A herd shall retain officially enzootic-bovine-leukosis-free status provided -

(i)

the condition in A(i) continues to be fulfilled;

(ii) any animals introduced into the herd come from an officially enzootic-

bovine-leukosis-free herd;

(iii) all animals over twenty-four months of age continue to react negatively

to a test carried out in accordance with Chapter II at intervals of three

years;

(iv) breeding animals introduced into a herd and originating from a third

country have been imported in accordance with European Union

Council Directive 72/462/EEC.

The officially leukosis-free status of a herd is to be suspended if the

conditions detailed in B are not fulfilled, or where as a result of laboratory tests or

on clinical grounds one or more bovine animals are suspected of having enzootic

bovine leukosis and the suspect animal(s) are immediately slaughtered.

The status is to remain suspended until the following requirements are

complied with -

1. If a single animal in an officially enzootic-bovine-leukosis-free herd has

reacted positively to one of the tests referred to in Chapter II, or where

infection is otherwise suspected in one animal in a herd -

(i)

the animal which has reacted positively, and, in the case of a cow,

any calf it may have produced, must have left the herd for

slaughter under the supervision of the veterinary authorities;

(ii) all animals in the herd more than twelve months old have reacted

negatively to two serological tests (at least four months and less

than twelve months apart) carried out in accordance with Chapter

II three months at least after removal of the positive animal and

any possible progeny thereof;

(iii) an epidemiological inquiry has been conducted with negative

results and the herds linked epidemiologically to the infected herd

have been subjected to the measures laid down in (ii). However,

the competent authority may grant a derogation from the

obligation to slaughter the calf of an infected cow where it was

separated from its mother immediately after calving. In this case,

the calf must be made subject to the requirements provided for in

2(iii).

2. Where more than one animal from an officially enzootic-bovine-leukosis-

free herd has reacted positively to one of the tests referred to in Chapter II, or where

infection has otherwise been suspected in more than one animal in a herd -

(i)

any animals which have reacted positively and, in the case of cows,

their calves, must be removed for slaughter under the supervision of the

veterinary authorities;

(ii) all animals in the herd aged over twelve months must react negatively to

two tests carried out in accordance with Chapter II at an interval of at

least four months and no more than twelve months;

(iii) all other animals in the herd must, after identification, remain on the

holding until they are aged over twenty-four months and have been

tested in accordance with Chapter II after reaching that age, except that

the competent authority may permit such animals to go directly for

slaughter under official supervision;

(iv) an epidemiological inquiry has been conducted with negative results

and any herd linked epidemiologically to the infected herd has been

subjected to the measures laid down in (ii). However, the competent

authority may grant a derogation from the obligation to slaughter the

calf of an infected cow where it was separated from its mother

immediately after calving. In this case, the calf must be made subject to

the requirements provided for in 2(iii).

In accordance with the procedure in Article 17 of the European Union

Council Directive 64/432/EEC and on the basis of information supplied in

accordance with regulation 8, a Member State or part of a Member State may be

considered officially enzootic-bovine leukosis-free if -

(a) all the conditions of paragraph A are fulfilled and at least 99,8% of the

bovine herds are officially enzootic-bovine-leukosis-free; or

(b) no case of enzootic bovine leukosis has been confirmed in the Member

State or the part of the Member State for the past three years, and the

presence of tumours suspected of being due to EBL is compulsorily

notifiable, with investigations of cause being carried out, and in the case

of a Member State, all animals aged over twenty-four months in at least

10% of the herds, selected randomly, have been tested with negative

results in accordance with Chapter II in the previous twenty-four

months, or in the case of a part of a Member State, all animals aged over

twenty-four months have undergone a test provided for in Chapter II

with negative results in accordance with Chapter II in the previous

twenty-four months; or

(c) any other method which demonstrates to a confidence rating of 99% that

less than 0,2% of herds were infected.

F.

A Member State or a region of a Member State is to retain officially

enzootic-bovine-leukosis-free status if -

(a) all animals slaughtered within the territory of that Member State or

region are submitted to official post-mortem examinations at which all

tumours which could be due to the EBL virus are sent for laboratory

examination,

(b) the Member State reports to the European Commission all cases of

enzootic bovine leukosis that occur in the region,

(c) all animals which react positively to any of the tests provided for in

Chapter II are slaughtered and their herds remain subject to restrictions

until re-establishment of their status in accordance with Section D, and

(d) all animals more than two years old have been tested, either once in the

first five years after the status is granted under Chapter II or during the

first five years after the grant of the status under any other procedure

demonstrating with a certainty level of 99% that less than 0,2% of herds

have been infected.

However, where no case of enzootic bovine leukosis has been recorded in a

Member State or in a region of a Member State in a proportion of one herd out of

10,000 for at least three years, a decision may be taken in accordance with the

procedure laid down in Article 17 of the European Union Council Directive 64/432/

EEC that routine serological tests may be reduced provided that all bovine animals

more than twelve months old in at least 1% of herds, selected at random each year,

have been subjected to a test carried out in accordance with Chapter II.

G.

The officially enzootic-bovine-leukosis-free status of a Member State or part

of a Member State is to be suspended, in accordance with the procedure in Article 17

of the European Union Council Directive 64/432/EEC if, as a result of investigations

carried out in accordance with paragraph F above, there is evidence of a significant

change in the situation as regards enzootic bovine leukosis in a Member State or part

of a Member State which has been recognised as officially enzootic-bovine-leukosis-

free.

The officially enzootic-bovine-leukosis-free status may be restored in accordance

with the procedure in regulation 17 when the criteria laid down by the same

procedure are fulfilled.

CHAPTER II

TESTS FOR ENZOOTIC BOVINE LEUKOSIS

Tests for enzootic bovine leukosis shall be carried out by the immunediffusion test

under the conditions described in A and B or by the enzymelinked immunosorbent

assay (ELISA) under the conditions described in C. The immune diffusion method

may only be used for individual tests. If test results are the subject of a duly

substantiated challenge, an additional check shall be carried out by means of the

immunediffusion test.

A.

Agar gel immunediffusion test for enzootic bovine leukosis

1. The antigen to be used in the test must contain bovine leukosis virus

glycoproteins. The antigen must be standardized against a standard serum (EI serum)

supplied by the State Veterinary Serum Laboratory, Copenhagen.

2. National reference laboratories designated by the competent authority in

accordance with rules 6 for coordinating standards and methods of diagnosis of the

tests for enzootic bovine leucosis shall be made responsible for calibrating the

standard working antigen of the laboratory against the official EC standard serum

(EI serum) provided by the National Veterinary Institute, Technical University of

Denmark.

3. The standard antigens used in the laboratory shall be submitted at least once

a year to the national reference laboratories designated by the competent authority in

accordance with rule 6A, for testing against the official EC standard serum. Apart

from such standardisation, the antigen in use may be calibrated in accordance with

the method described under paragraph B (Method for antigen standardization).

4. The reagents for the test shall consist of -

(a) antigen: the antigen must contain specific glycoproteins of enzootic

bovine leukosis virus which has been standardized against the official

EEC serum;

(b) the test serum;

(c) known positive control serum;

(d) agar gel

0,8% agar, 8,5% NaCI, 0,05 M Trisbuffer pH 7,2; 15 ml of this agar

must be introduced into a petri dish of 85 mm diameter, resulting in a

depth of 2,6 mm of agar.

5. A test pattern of seven moisture free wells must be cut in the agar to the

bottom of the plate; the pattern must consist of one central well and six wells in a

circle around it.

Diameter of central well: 4 mm

Diameter of peripheral wells: 6 mm

Distance between central and peripheral wells: 3 mm

6. The central well must be filled with the standard antigen. Peripheral wells 1

and 4 (see diagram below) are filled with the known positive serum, wells 2, 3, 5 and

6 with the test sera. The wells must be filled until the meniscus disappears.

7. This results in the following quantities being obtained -

antigen: 32 µl

control serum: 73 µl

test serum: 73 µl.

8. Incubation must be for 72 hours at room temperature (20 to 27°C) in a

closed humid chamber.

9. The test may be read at 24 and 48 hours but a final result may not be

obtained before 72 hours

(a) a test serum is positive if it forms a specific precipitin line with the BLV

antigen and forms a complete line of identity with the control serum;

(b) a test serum is negative if it does not form a specific precipitin line with

the BLV antigen and if it does not bend the line of the control serum;

(c) the reaction cannot be considered conclusive if it -

(i)

bends the line ofthe control serum towards the BLV antigen well

without forming a visible precipitin line with the antigen; or

(ii) if it cannot be read either as negative or as positive. In

inconclusive reactions the test may be repeated and concentrated

serum utilized.

10. Any other well configuration or pattern may be utilized provided that the E4

serum diluted 1:10 in negative serum can be detected as positive.

Method for antigen standardization

Solutions and materials required

1. 40 ml of 1,6% agarose in 0,05 M Tris/HCl buffer, pH 7,2 with 8,5% NaCI;.

2. 15 ml of a bovine leukosis serum, having antibody only to bovine leukosis

virus glycoproteins, diluted 1:10 in 0,05 M Tris/HCl buffer, pH 7,2 with 8,5% NaCI;

3. 15 ml of a bovine leukosis serum, having antibody only to bovine leukosis

virus glycoproteins, diluted 1:5 in 0,05 M Tris/HCl buffer, pH 7,2 with 8,5% NaCI;

4. four plastic petri dishes with a diameter of 85 mm;

5. a punch with a diameter of 4 to 6 mm;

6. a reference antigen;

7. the antigen which is to be standardized;

8. a water bath (56°C).

Procedure

Dissolve the agarose (1,6%) in the Tris/HCI buffer by carefully heating to 100°C.

Place in WC water bath for approximately one hour. Also, place the bovine leukosis

serum dilutions in a WC water bath.

Now mix 15 ml of the 56°C agarose solution with the 15 ml bovine leukosis serum

(1:10), quickly shake and pour 15 ml into each of two petri dishes. Repeat this

procedure with the bovine leukosis serum diluted 1:5.

When the agarose has hardened, holes are made in it as follows -

Addition of antigen

(i)

Petri dishes 1 and 3

well A undiluted reference antigen;

well B 1:2 diluted reference antigen;

wells C and E reference antigen;

well D undiluted test antigen.

(ii) Petri dishes 2 and 4

well A undiluted test antigen;

well B 1:2 diluted test antigen;

well C 1:4 diluted test antigen;

well D 1:8 diluted test antigen.

Additional instructions

1. The experiment shall be carried out with two serum dilutions (1:5 and 1:10)

in to achieve optimal precipitation.

2. If the precipitation diameter is too small with both dilutions, then the serum

must be further diluted.

3. If the precipitation diameter in both dilutions is too large and faint, then a

lower serum must be chosen.

4. The final concentration of the agarose must be 0,8%; that of the sera 5 and

10% respectively.

5. Plot the measured diameters in the following co-ordinate system. The

dilution of the antigen to be tested with the same diameter as the reference antigen is

the working dilution.

C.

Enzymelinked immunosorbent assay (ELISA) for detecting enzootic bovine

leukosis

1. The material and reagents to be used are as follows -

(a) solid phase microplates, cuvettes or any other solid phase;

(b) the antigen is fixed to the solid phase with or without the aid of

polyclonal or monoclonal catching antibodies. If antigen is coated

directly to the solid phase, all test samples giving positive reactions

have to be retested against control antigen in the case of EBL. The

control antigen should be identical to the antigen except for the BLV

antigens. If catching antibodies are coated to the solid phase, the

antibodies must not react to antigens other than BLV antigens;

(c) the biological fluid to be tested;

(d) a corresponding positive and negative control;

(e) conjugate;

(f)

a substrate adapted to the enzyme used;

(g) a stopping solution, if necessary;

(h) solutions for the dilution of the test samples for preparations of the

reagents and for washing;

(i)

a reading system appropriate to the substrate used.

2. Standardization and sensitivity of test. The sensitivity of the ELISA assay

must be of such a level that E4 serum is scored positive when diluted 10 times

(serum samples) or 250 times (milk samples) more than the dilution obtained of

individual samples when these are included in pools. In assays where samples

(serum and milk) are tested individually E4 serum diluted 1 to 10 (in negative

serum) or 1 to 250 (in negative milk) must be scored positive when tested in the

same assay dilution as used for the individual test samples. The official institutes

listed in A.2 will be responsible for checking the quality of the ELISA method, and

in particular for determining, for each production batch, the number of samples to be

pooled on the basis the count obtained for the E4 serum.

T h e E 4 s e r u m w i l l b e s u p p l i e d b y t h e N a t i o n a l Ve t e r i n a r y L a b o r a t o r y,

Copenhagen.

3. Conditions for use of the ELISA test for EBL. The Elisa method may be

used on a sample of milk or whey taken from the milk collected from a farm with at

least 30% of dairy cows in milk.

If this method is used, measures must be taken to ensure that the samples taken

can be identified with the animals from which the milk or sera examined were taken.

(1) Animals for breeding or production must, in addition to

the requirements of regulations 3, 4 and 5 -

(a) have remained in a single holding of origin for a

period of thirty days prior to loading, or since birth in

the holding of origin where the animals are less than

ANIMAL HEALTH PROBLEMS AFFECTING INTRA-

COMMUNITY TRADE IN BOVINE ANIMALS AND SWINE

thirty days old. The official veterinarian must, on the

basis of the official identification provided for in

regulation 3(2)(c) and official records, be satisfied that

the animals have complied with this condition and

furthermore that the animals have originated in Malta

or in the European Community or have been imported

from a third country in compliance with European

Community animal health legislation

Provided that in the case of animals transiting through

an approved assembly centre in Malta or in the

Member State of origin, the period during which the

assembly of these animals takes place outside the

holding of origin shall not exceed six days;

(b) with regard to animals imported from a third country

into the territory of Malta which is not the ultimate

destination, be transported to the Member State of

destination as quickly as practicable under cover of a

certificate issued under Article 7 of European Union

Council Directive 91/496/EEC;

(c) with regard to animals imported from a third country

upon arrival in the territory of Malta and before any

further movements, satisfy the requirements of these

regulations, and in particular the residency

requirement in subregulation (1)(a), and may not be

brought into the herd until the veterinarian responsible

for that holding has ascertained that the animals in

question are not likely to jeopardise the health status

of the holding

Provided that if an animal from a third country is

introduced into a holding no animal from the holding

may be traded for thirty days following introduction

unless the imported animal is isolated from all other

animals on the holding.

(2) Bovine animals for breeding and production must, in

addition to the requirements in regulation 3, 4 and 5 -

(a) come from an officially tuberculosis-free bovine herd,

and in the case of animals more than six weeks old,

have reacted negatively to an intradermal tuberculin

test carried out in accordance with the provisions of

point 2.2 of Schedule B either during the thirty days

prior to leaving the herd of origin or in a place and

under conditions to be defined in accordance with the

procedure referred to in regulation 17

Provided that this intradermal tuberculin test is not

required if the animals originate in a Member State or

part of a Member State recognised as officially

tuberculosis free or in a Member State or part of a

Member State with an approved surveillance network;

(b) in the case of uncastrated animals which come from an

officially brucellosis free bovine herd and more than

twelve months old, have shown a brucella count lower

that thirty international units (IU) of agglutination per

millilitre when given a serum agglutination test (or any

test approved by Standing Veterinary Committee

(SVC) procedure following the adoption of the

relevant protocols) carried out during the thirty days

prior the leaving the herd of origin and complying with

the provisions of Annex C Section 2.2.2.1.(a)

Provided that this serurn agglutination test (or any test

approved by SVC procedure following the adoption of

the relevant protocols) is not required if the animals

originate in a Member State or part of a Member State

recognized as officially bruceliosis free or in a

Member State or part of a Member State with an

approved surveillance network;

(c) come from an officially enzootic-bovine-leukosis-free

herd and, if more than twelve months old, have reacted

negatively to an individual test carried out during the

thirty days prior to leaving the herd of origin and

complying with the provisions of Schedule D

Provided that the test is not required if the animals

originate in a Member State or part of a Member State

recognised as officially enzootic-bovine-leukosis free

or in a Member State or part of a Member State with an

approved surveillance network;

(d) at no time between leaving the holding of origin and

arriving at destination come into contact with bovine

animals which meet only the requirements in

subregulation (3);

(e) until 31 December 2000, not be subject to the test

requirements laid down in paragraph (a) or (b) in the

case of bovine animals aged less than thirty months

intended for meat production which -

(i)

come from a beef holding officially

tuberculosis-free and officially brucellosis-free;

(ii) are accompanied by an animal health certificate

with paragraph 7 in Section A of Annex F Model

1 duly completed;

(iii) remain under supervision until their slaughter;

(iv) have not come into contact during transport with

bovine animals not coming from herds officially

free from those diseases.

and provided that -

(i)

these arrangements are restricted to trade

between Member States or regions of Member

States with the same health status with regard to

tuberculosis or brucellosis;

(ii) the Member State of destination takes all

necessary measures to avoid any contamination

of indigenous herds;

(iii) the Member States put in place a proper system

of random sampling, inspections and controls

designed to ensure the efficient implementation

of these regulations;

(iv)

the Commission monitors the proper operation

of the Directive so as to ensure that Member

States comply fully with the regulations.

(3) Bovine animals for slaughter must, in addition to the

requirements in regulations 3, 4 and 5, come from herds that are

officially tuberculosis free, officially enzootic-bovine-leukosis free

and in the case of uncastrated bovines, from herds that are

officially brucellosis free.

The competent authority shall designate institutes, national

reference labo ratori es o r official institu tes resp onsible f or

coordinating the standards and methods of diagnosis referred to in

Schedules A to D. It shall maintain updated lists thereof and make

them available to other Member States and to the public. The tasks

and responsibilities of such institutes, national reference

laboratories and official institutes are set out in Schedules B and C

and in Chapter II of Schedule D. Detailed rules for the uniform

application of this rule may be adopted in accordance with the

procedure referred to in rule 17.

(a)

Bovine diseases

-

Foot-and-mouth disease

-

Rabies

-

Tuberculosis

-

Brucellosis

-

Contagious bovine pleuropneumonia

-

Enzootic bovine leukosis

-

Anthrax

(b)

Swine diseases

-

Rabies

-

Brucellosis

-

Classical swine fever African swine fever

-

Foot-and-mouth disease

-

Swine vesicular disease

-

Anthrax

Animals for slaughter which have been taken on arrival in

the territory of Malta -

(a) to a slaughterhouse, must be slaughtered there as soon

as possible but at least within seventy-two hours of

arrival,

in

accordance

with

animal

health

requirements, or

(b) to an approved assembly centre, must be removed

directly to a slaughterhouse to be slaughtered as soon

as possible but at the latest within three working days

of arrival at the assembly centre, in accordance with

animal health requirements. At no time, between their

arrival at the assembly centre and their arrival at the

slaughterhouse, may they come into contact with

cloven-hoofed animals other than animals that fulfil

the conditions laid down in these regulations.

-

Aujeszky’s disease

-

Infectious bovine rhinotracheitis

-

Brucella suis infection

-

Transmissible gastroenteritis.

The suspected presence of any of the diseases referred to in

Schedule E (I) is compulsorily and immediately notifiable to the

competent authority.

The competent authority shall forward to the European

Commission by 31 May each year, and for the first time in 2004,

details of the occurrence of diseases listed in Schedule E (I) and of

any other diseases covered by the additional guarantees provided

for by European Community legislation in the territory of Malta in

the previous calendar year including details of the monitoring and

eradication programmes in operation. This information shall be

based on uniform criteria established by European Commission.

The Commission shall present this information to the Member

States in the framework of the SVC and in particular may utilize it

in relation to the decisions referred to in Schedules A and D.

Where in these regulations reference is made to Schedule F of these regulations or

Annex F of the European Union Council Directive 64/432/EEC reference should be

made to the European Union Commission Regulation (EC) No 599/2004 concerning

the adoption of a harmonised model certificate and inspection report linked to intra-

Community trade in animals and products of animal origin.

(1) On the basis of a Veterinary Services proposal, the

Minister in charge of Agriculture may define, by virtue of an

implementing regulation a compulsory national control programme

for one of the contagious diseases listed in Annex E (II) to

Directive 64/432/EEC for all of the territory of Malta. The said

programme shall be submitted to the European Commission and

outlined in particular

(a) the distribution of the disease in the Member State,

(b) the reasons for the programme, taking into

consideration the importance of the disease and the

programme’s likely benefit in relation to its cost,

(c) the geographical area in which the programme will be

implemented,

(d) the status categories to be applied to the animal

establishments, the standards which must be attained

in each category, and the test procedures to be used,

(e) the programme monitoring procedures, the results of

which must be supplied at least annually to the

Commission,

(f)

the action to be taken if, for any reason, an

establishment loses its status,

(g) the measures to be taken if the results of the tests

carried out in accordance with the provisions of the

programme are positive.

(2) The Commission shall examine the programmes presented

by the Member States. Programmes as referred to in subregulation

(1) may be approved in compliance with the criteria laid down in

paragraph I in accordance with the procedure provided for in

Article 17 of the European Union Council Directive 64/432/EEC.

According to the same procedure, the additional guarantees,

general or limited, which may be required in intra-Community

trade, shall be defined at the same time or at the latest three months

after approval of the programmes. Such guarantees must not exceed

those which the Member State implements nationally.

(3) Programmes submitted by Member States may be amended

or supplemented in accordance with the procedure laid down in

Article l7 of the European Union Council Directive 64/432/EEC.

Amendments or additions to programmes which have already been

approved or to guarantees which have been defined in accordance

with subregulation (2) may be approved under the same procedure.

(4) The dispatching of pigs intended for breeding or production

destined for the Member States or regions free of Aujeszky’s

disease listed in Annex I of Commission Decision 2001/618/EC

and coming from the territory of Malta or region not listed in that

Annex is authorised subject to the following conditions

(a) Aujeszky’s disease must be compulsorily notifiable in

Malta or regioro of origin;

(b) a plan for the control and eradication of Aujeszky’s

disease, fulfilling the criteria laid down in the first

paragraph of this regulation, must be in place in Malta

or regions of origin under the supervision of the

Veterinary Services. Appropriate measures on pig

transport and movements must be in place according to

this plan for preventing a spread of disease between

holdings of a different status;

(c) with regard to the holding of origin of the pigs

(i)

no clinical, pathological or serological evidence

of Aujeszky’s disease has been recorded in the

previous twelve months in the holding in

question;

(ii) no clinical, pathological or serological evidence

of Aujeszky’s disease has been recorded in the

previous twelve months in the holdings located

in an area of 5 km surrounding the holding of

origin of the pigs; however, this provision shall

not apply if, in these latter holdings, disease

monitoring and eradication measures have been

regularly applied under the supervision of the

Veterinary Services and in accordance with the

eradication plan referred to in paragraph (b), and

these measures have effectively prevented any

spread of disease to the holding in question;

(iii) vaccination against Aujeszky's disease has not

been carried out for at least twelve months;

(iv) the pigs have been subjected on at least two

occasions at a distance of at least four months to

a serological survey for the presence of ADV-gE

or ADV-gB or ADV-gD antibody or to the whole

Aujeszky's disease virus. This survey must have

shown the absence of Aujeszky’s disease and

that vaccinated pigs have been free from gE

antibodies;

(v) no pigs have been introduced from holdings of a

lower animal health status as regards Aujeszky’s

disease in the previous twelve months, unless

they have been tested for Aujeszky’s disease

with negative results;

(d) the pigs to be moved

(i) have not been vaccinated;

(ii) have been kept isolated in accommodation

approved bv the Veterinary Services, during the

thirty days prior to movement, and in such a way

that any risk of spreading Aujeszky’s disease to

these pigs is prevented;

(iii) must have lived in the holding of origin or in a

holding of an equivalent status since birth, and

have remained in the holding of origin for at

least

- thirty days, in the case of pigs intended for

production;

-

ninety days, in the case of pigs intended for

breeding,

have been subjected with negative results to at least

two serological tests for ADV-gB or ADV-gD or the

whole Aujeszky’s disease virus, at a distance of at

least thirty days between each test. However, in case of

pigs less than four months old, the serological test for

ADV-gE may also be used. Sampling for the last test

must be performed within fifteen days prior to

shipment. The number of pigs tested in the isolation

unit must be sufficient to detect

(i)

2% seroprevalence with 95% confidence in the

isolation unit in case of pigs intended for

production;

(ii) 0,1% seroprevalence with 95% confidence in the

isolation unit in case of pigs intended for

breeding.

However, the first of the two tests shall not be

necessary if

(i)

in the framework of the plan referred to in

paragraph (b), a serological survey has been

carried out in the holding of origin between

forty-five and seventeen days prior to shipment,

demonstrating the absence of Aujeszky’s disease

antibodies and that vaccinated pigs have been

free from gE antibodies;

(ii) the pigs to be moved have lived in the holding of

origin since birth;

(iii) no pigs have moved on to the holding of origin

while the pigs to be moved have been kept in

isolation.

(5) The dispatching of pigs intended for slaughter destined for

the Member States or regions free of Aujeszky’s disease listed in

Annex I of Commission Decision 2001/618/EC and coming from

Malta or region not listed in that Annex, is authorised subject to the

following conditions

(a) Aujeszky’s disease must be compulsorily notifiable in

Malta or region of origin;

(b) a plan for the control and eradication of Aujeszky’s

disease is in place in Malta or regions of origin of the

pigs, fulfilling the criteria laid down under European

Union Law;

(c) all the pigs in question must be transported directly to

the slaughterhouse of destination and either

(i)

they come from a holding which fulfils the

conditions required by European Union Law, or

(ii) they have been vaccinated against Aujeszky’s

disease at least fifteen days prior to their

shipment and come from a holding of origin

where

-

in the framework of the plan referred to in

paragraph

(b),

Aujeszky’s

disease

monitoring and eradication measures have

been regularly applied under the supervision

of the Veterinary Services for the previous

twelve months;

-

they had remained for at least thirty days

before dispatch and where no clinical or

pathological evidence of this disease has

been detected at the moment of completion

of the health certificate referred to in

regulation 5, or

-

they have not been vaccinated and they

proceed from a holding where

1. in the framework of the plan referred to

in paragraph (b), Aujeszky’s disease

monitoring and eradication measures

have been regularly applied under the

supervision of the Veterinary Services in

the previous twelve months and no

clinical, pathological or serological

evidence of Aujeszky’s disease has been

recorded in the previous six months;

2. vaccination against Aujeszky’s disease

and introduction of vaccinated pigs have

been forbidden by the Veterinary

Services, since the holding is in the

process of reaching the highest status as

regards

Aujeszky’s

disease

in

accordance to the plan referred to in

paragraph (b);

3. they have lived for at least ninety days

before dispatch.

(6) Pigs intended for breeding destined for the Member States

or regions listed in Annex II of Commission Decision 2001/618/

EC, where approved Aujeszky’s disease eradication programmes

are in place, must either

(a) come from Member States or regions listed in Annex I

of Commission Decision 2001/618/EC, or

(b) come from

(i) Member States or regions listed in Annex II, and

(ii) a holding which fulfils the requirements of

subregulation (4)(c); or

(c) fulfil the following conditions

(i)

Aujeszky’s disease must be compulsorily

notifiable in Malta or region where pigs are

originating,

(ii) a plan for the control and eradication of

Aujeszky’s disease is in place in Malta or region

of origin, which fulfils the criteria laid down in

subregulation (4)(b),

(iii) no clinical, pathological or serological evidence

of Aujeszky’s disease has been recorded in the

previous twelve months in the holding of origin

of the pigs in question,

(iv) the pigs must have been isolated in

accommodation approved by the Veterinary

Services for the thirty days immediately prior to

movement and kept isolated in such a way that

any risk of spreading of Aujeszky’s disease is

prevented,

(v) the pigs must have been subjected, with negative

results, to a serological test for the presence of

gE antibodies. Sampling for the last test must be

performed within fifteen days prior to shipment.

The number of pigs tested must be sufficient to

detect 2% seroprevalence with 95% confidence

in these pigs,

(vi) the pigs must lave lived in the holding of origin

or in a holding of an equivalent status since

birth, and have remained in the holding of origin

for at least ninety days.

(7) Pigs intended for production destined for the Member

States or regions listed in Annex II of Commission Decision 2001/

6 1 8 / E C , w h e r e a p p r o v e d A u j e s z k y ’s d i s e a s e e r a d i c a t i o n

programmes are in place, must either

(a) come from Member States or regions listed in Annex 1

of Commission Decision 2001/618/EC, or

(b) come from

(i)

Member States or regions listed in Annex II

Commission Decision 2001/618/EC, and

(ii) a holding which fulfils the requirements of

subregulation (4)(c), or

(c) fulfil the following conditions

(i)

Aujeszky’s disease must be compulsorily

notifiable in Malta or region of origin;

(ii) a plan for the control and eradication of

Aujeszky’s disease is in place in Malta or region

of origin, which fulfils the criteria laid down in

subregulation (4)(b);

(iii) no clinical, pathological or serological evidence

of Aujeszky’s disease has been recorded in the

previous twelve months in the holding of origin

of the pigs in question;

(iv) a serological survey for Aujeszky’s disease,

demonstrating its absence and that vaccinated

pigs have been free from gE antibodies, has been

carried out in the holding of origin and between

forty-five and one hundred and seventy days

prior to shipment;

(v)

the pigs must either have lived in the holding of

origin since birth or have remained in such

holdings for at least thirty days after

introduction from a holding of an equivalent

status, where a serological survey equivalent to

the one referred to in sub-paragraph (iv) has

been carried out.

(8) The serological tests carried out to monitor or detect

Aujeszky’s disease in pigs in accordance with these regulations

must meet the standards laid down in Annex III to the European

Union Commission Decision 2001/618/EC.

(9) Without prejudice to Article 10(3) of Directive 64/432/

EEC, infor mation of the occurrence of Aujeszky’s disease,

including details of the monitoring and eradication programmes in

operation in Malta where monitoring and eradication programmes

wi ll b e in pl ace, m ust be provid ed at least annu ally b y the

Veterinary Services in accordance with the uniform criteria laid

down in Annex IV to Commission Decision 2001/618/EC.

(10) Without prejudice to the provisions laid down in

Community legislation concerning health certificates, before the

completion, for animals of the porcine species destined for Member

States or regions listed in Annex I or II to Commission Decision

2001/618/EC, of section C of the health certificate required by

Directive 64/432/EC, the official veterinarian shall ascertain

(a) the status of the holding and of the Member State or

region of origin of the pigs in question as regards

Aujeszky’s disease;

(b) in case the pigs are not originating from a Member

State or a region free of the disease, the status of the

holding and of the Member State or regions of

destination for the pigs in question as regards

Aujeszky’s disease;

(c) the compliance of the pigs in question with the

conditions laid down in Commission Decision 2001/

618/EC.

(11) For animals of the porcine species destined for Member

St a t e s o r r e g i o n s l i s t e d i n A n n e x I o r I I , E u r o p e a n U n i o n

Commission Decision 2001/618/EC, the certification under

subregulation (10) shall be completed and supplemented as

follows

(a) in the first indent, after the word "disease:" the word

"Aujeszky" must be added;

(b) in the second indent, reference shall be made to

Commission Decision 2001/618/EC. In the same line,

the number of the Article of Commission Decision

2001/618/EC, which is relevant for the pigs in

question, shall be quoted between brackets.

(12) The Veterinary Services must ensure that when pigs

destined for Member States or regions listed in Annex I or II to

Commission Decision 2001/618/EC are transported, they shall not

come in contact with pigs of different or unknown status, as regards

Aujeszky’s disease, during transport or transit.

(1) Where the competent authority considers that the

Maltese territory is free from one of the diseases listed in Annex E

(II), they shall present to the European Commission appropriate

supporting documentation, setting out in particular -

(a) the nature of the disease and the history of its

occurrence in its territory;

(b) the results of surveillance testing based on serological,

microbiological, pathological or epidemiological

investigation and on the fact that the disease must by

law be notified to the competent authorities;

(c) the period over which the surveillance was carried out;

(d) where applicable, the period during which vaccination

against the disease has been prohibited and the

geographical area concerned by the prohibition;

(e) the arrangements for verifying the absence of the

disease.

(2) The documentation submitted by the competent authority

shall be examined by the European Commission. The additional

guarantees, general or specific, which may be required in Intra-

Community trade may be defined in accordance with Article 17 of

the European Union Council Directive 64/432/EEC. Such

guarantees must not exceed those which are implemented

nationally.

(3) The competent authority shall notify the European

Commission of any change in the details specified in subregulation

(1) which relate to the disease, in particular regarding any new

outbreaks of the disease. The guarantees defined in accordance

with subregulation (2) may, in the light of such notification, be

amended or withdrawn in accordance with the procedure laid down

in Article 17 of the European Union Council Directive 64/432/

EEC.

(1) To be approved by the competent authority, assembly

centres meet the following conditions at least. They must -

(a) be under the control of an official veterinarian who

shall ensure that, in particular, the provisions of

regulation 4(1) and (2) are complied with;

(b) be located in an area which is not subject to

prohibition or restrictions in accordance with relevant

European Community legislation and, or Maltese

regulations on animal diseases;

(c) be cleaned and disinfected before use, as required by

the official veterinarian;

(d) they must have, taking into account the animal

capacity of the assemblv centre -

(i)

a facility dedicated exclusively for this purpose

when used as an assembly centre;

(ii) appropriate facilities for loading, unloading and

adequate housing of a suitable standard for the

animals, for watering and feeding them, and for

giving them any necessary treatment; these

facilities must be easy to clean and disinfect;

(iii) appropriate inspection facilities;

(iv) appropriate isolation facilities;

(v) appropriate equipment for cleaning and

disinfecting rooms and trucks;

(vi) an appropriate storage area for fodder, litter and

manure;

(vii)

an appropriate system for collecting waste

water;

(viii) the use of an office for the official veterinarian;

(e) admit only animals that are identified and come from

herds that are officially free of tuberculosis,

brucellosis and leukosis or slaughter animals meeting

the conditions set out in the present regulations and in

particular regulation 6(3). To this end, when animals

are admitted the owner or person in charge of the

centre shall ensure they are properly identified and

accompanied by health documents or appropriate

certificates for the species and categories involved;

(f)

be regularly inspected to ascertain that the

requirements for approval continue to be fulfilled.

(2) The owner or person in charge of the assembly centre shall

be required, on the basis either of the accompanying documents for

the animals or of the identification numbers or marks of the

animals, to record on a register or a database and retain for a

minimum period of three years the following information

(a) the name of the owner, the origin, date of entry and

exit, number and identification of the bovine animals

or the registration number of the holding of origin or

of the herd of origin of the pigs entering the centre and

their proposed destination,

(b) the registration number of the transporter and the

licence number of the lorry delivering or collecting

animals from the centre.

(3) The competent Authority shall issue an approval number to

each approved assembly centre. Approvals of assembly centres

may be limited to a particular species or to animals for breeding

and production or to animals for slaughter. The competent authority

shall draw up and keep updated a list of approved assembly centres

and their approval numbers and make it available to other Member

States and to the public.

(4) The competent authority may suspend or withdraw approval

in the event of failure to comply with this regulation or other

appropriate provisions of these regulations or other regulations in

respect of health restrictions. Approval may be restored when the

competent authority is satisfied that that assembly centre is in full

compliance with all the appropriate provisions of these regulations.

(5) The competent authority shall ensure that, when operating,

assembly centres have sufficient approved veterinarians to carry

out all duties.

(6) Any detailed rules shall be adopted in accordance with the

requirements of the European Community and under the procedure

provided for in Article 17 of European Union Council Directive 64/

432/EEC.

(1) The transporters referred to in Article 5 of European

Union Council Directive 91/628/EEC meet the following additional

conditions -

(a) for the carriage of animals they must use means of

transport that are -

(i)

constructed in such a way that the animal faeces,

litter or feed cannot leak or fall out of the

vehicle;

(ii) cleaned and disinfected immediately after every

animal transport operation or that of any product

which could affect animal health and if

necessary before any new loading of animals,

using disinfectants officially authorised by

competent authority;

(b) they must either have appropriate cleaning and

disinfection facilities approved by the competent

authority, including facilities for storing litter and

dung, or they must provide documentary evidence that

these operations are performed by a third party

approved by the competent authority.

(2) The transporter must ensure that for each vehicle used for

the transport of animals a register is kept containing the following

information at least which shall be retained for a minimum period

of three years

(i)

places and dates of pickup, and the name or business

name and address of the holding of assembly centre

where the animals are picked up;

(ii) places and dates of delivery, and the name or business

name and address of the consignee(s);

(iii) species and number of animals carried;

(iv) date and place of disinfection;

(v) details of accompanying documentation, number,

(serial number, etc).

(3) Transporters shall ensure that the consignment or animals

do not at any time, between leaving the holdings or the assembly

centre of origin and arriving at their destination, come into contact

with animals of a lower health status.

(4)

Transporters shall give a written undertaking stating in

particular that -

(i)

all the measures necessary to comply with these

regulations shall be taken and in particular the

provisions laid down in this regulation and relating to

the appropriate documentation that must accompany

the animals,

(ii) the transport of animals is entrusted to staff who

possess the necessary ability, professional competence

and knowledge.

(5) In the event of failure to comply with the provisions of this

regulation the requirements of Article 18 of European Union

Council Directive 91/628/EEC shall apply mutatis mutandis

relating to animal health.

(1) In the territory of Malta all dealers are registered,

approved and issued with an approval number by the competent

authority and that they comply with the following conditions at

least -

(a) they must deal only in animals that are identified and

come from herds that are officially free of

tuberculosis, brucellosis and leukosis or slaughter

animals meeting the conditions set out in these

regulations and in particular regulation 6(3). To this

end, the dealer shall ensure that the animals are

properly identified and are accompanied by health

documents as appropriate for the species involved.

However, the competent authority may authorise the

marketing of identified animals originating from the

territory of Malta which do not fulfil the conditions

laid down in this paragraph, in so far as they are

brought direct to a slaughterhouse in the territory of

Malta without passing through their facilities, for

slaughter as soon as possible in order to prevent the

spreading of diseases. The necessary provisions should

be taken to ensure that such animals, when they reach

the abattoir, cannot come into contact with other

animals and that they are slaughtered apart from other

animals;

(b) the dealer shall be required, either on the basis of the

document accompanying the animals, or on the basis

of identification numbers or marks on the animals, to

keep a record or database and to store the following

data for at least three years

(i)

the name of the owner, origin, date of purchase,

categories, number and identification of bovine

anmals or registration number of the holding of

origin or of the herd of origin of pigs purchased,

(ii) the registration number of the transporter and, or

the licence number of the lorry delivering and

collecting animals,

(iii) the name and address of the purchaser and the

destination of the animal,

(iv)

copies of route plans and, or serial number of

health certificates as applicable;

(c) when the dealer keeps animals on his premises he shall

ensure that -

(i)

specific training is given to the staff in charge of

the animals in applying the requirements of

these regulations and in the care and welfare of

the animals,

(ii) controls and tests if necessary on the animals are

carried out regularly by the official veterinarian

and that all necessary steps are taken to prevent

the spread of disease.

(2) In the territory of Malta all premises used by a dealer in

connection with his business shall be registered and issued with an

approval number by the competent authority and that they comply

with the following conditions at least -

(a) they must be under the control of an official

veterinarian;

(b) they must be located in an area which is not subject to

prohibition or restrictions in accordance with relevant

European Community legislation or Maltese

legislation;

(c) they must have -

(i)

appropriate facilities of sufficient capacity and

in particular inspection facilities and isolation

facilities so that all animals can be isolated in

the event of an outbreak of a contagious disease,

(ii) appropriate facilities for unloading and where

necessary adequate housing of a suitable

standard for the animals, for watering and

feeding them, and for giving them any necessary

treatment; these facilities must be easy to clean

and disinfect,

(iii) an appropriate reception area for litter and

manure,

(iv) an appropriate system for collecting waste

water;

(d) be cleaned and disinfected before use, as required by

the official veterinarian.

(3) The competent authority may suspend or withdraw approval

in the event of failure to comply with this regulation or other

appropriate provisions of these regulations or other regulations in

respect of health restrictions. Approval may be restored when the

Veterinary Services is satisfied that the dealer is in full compliance

with all the appropriate provisions of these regulations.

(4) The competent authority must carry out regular inspections

to ascertain that the requirements of this regulation are fulfilled.

(5)

The competent authority shall draw up and keep updated a

list of approved dealers and registered premises used by dealers in

connection with their business and their approval numbers and

make that list available to other Member States and to the public.

Detailed rules for the uniform application of this sub-regulation

may be adopted in accordance with the procedure referred to in rule

(1) L-awtorità kompetenti tista’ tagħmel sistema ta’

network ta’ sorveljanza. Is-sistema ta’ network ta’ sorveljanza

għandha ssegwi ta’ l-anqas dawn l-elementi li ġejjin

(i)

il-merħliet,

(ii) is-sid jew kull persuna oħra naturali jew legali

responsabbli mir-razzett,

F’ANNIMALI BOVINI U MAJJALI

(iii) il-veterinarju approvat jew il-veterinarju uffiċjali

responsabbli mir-razzett,

(iv) l-awtorità kompetenti għat-territorju,

(v) il-veterinary diagnostic uffiċjali jew xi laboratorju

ieħor approvat mill-awtorità kompetenti,

(v) computer database.

Iżda l-veterinarji uffiċjali għall-biċċeriji u ċentri ta’ ġbir

approvati jkunu assoċjati mas-sistema ta’ network.

(2) L-għanjiet prinċipali tas-surveillance network system huma

li jagħmlu l-klassifikazzjoni uffiċjali ta’ l-irziezet, li jżommu din il-

klassifikazzjoni bi spezzjonijiet regolari, biex tinġabar l-

informazzjoni epidemioloġika u jagħmlu monitoraġġ tal-mard

sabiex jiżguraw konformità mad-disposizzjonijiet kollha ta’ dawn

ir-regolamenti u ta’ regolamenti oħra dwar ir-restrizzjonijiet tas-

saħħa

Iżda jekk ikun deċiż li titħaddem din is-sistema, dan is-

surveillance network għandu jkun mandatorju għall-irziezet kollha

fit-territorju ta’ Malta. Madankollu, l-awtorità kompeteni tista’

tawtorizza li tiġi stabbilita dik is-surveillance network system fuq

parti mit-territorju magħmul minn ħafna reġjuni adjaċenti. Fejn din

id-deroga tiġi akkordata, iċ-ċaqlieq ta’ dawn l-annimali lejn dik il-

parti tat-territorju minn reġuni oħra li ma humiex parti mis-

surveillance network system ser jiġu suġġetti għal dawn ir-

regolamenti

Iżda l-awtorità kompetenti għandha tistabbilixxi l-

obbligazzjonijiet u d-drittijiet li jimpinġu fuq il-veterinarji

approvati, il-persuni responsabbli mill-irziezet jew is-sidien

tagħhom u l-parteċipanti l-oħra fis-sistema inkluż il-persuni

responsabbli mill-ħruġ taċ-ċertifikati tas-saħħa.

(3) L-awtorità kompetenti għandha tiżgura li obbligazzjonijiet

imsemmija fis-subregolament (2) għandhom ta’ l-inqas jinkludu

dan li ġej

(a) Kull sid ta’ jew persuna responsabbli għar-razzett

irid -

(i)

jiżgura, b’kuntratt jew strument legali, is-

servizzi ta’ veterinarju approvat mill-awtorità

kompetenti;

(ii) isejjaħ immedjatament lill-veterinarju approvat

mir-razzett meta jissuspetta li jkun hemm marda

kontaġjuża jew xi marda li għandha tiġi

notifikata;

(iii) jinnotifika lill-veterinarju approvat bil-wasliet

kollha ta’ annimali fuq il-razzett tiegħu;

(iv) jiżola l-annimali qabel idaħħalhom fir-razzett

tiegħu sabiex iħalli lill-veterinarju approvat biex

jivverifika, fejn ikun adatt permezz tat-testijiet

meħtieġa, dwar jekk jistax jinżamm l-istatus tar-

razzett;

F’ANNIMALI BOVINI U MAJJALI

(b) Il-veterinarji approvati għandhom ikunu taħt il-

kontroll ta’ l-awtorità kompetenti u għandhom ikunu

konformi mal-ħtiġiet li ġejjin. Huma għandhom -

(i)

jilħqu l-kondizzjonijiet biex isegwu l-

professjoni veterinarja;

(ii) ma jkollhom l-ebda interess finanzjarju jew

rabtiet familjari mas-sid jew mal-persuna

responsabbli mir-razzett;

(iii) jippossjedu tagħrif partikolari fil-qasam tas-

saħħa ta’ l-annimali kif tapplika għall-annimali

ta’ l-ispeċi konċernati. Dan ifisser illi jridu -

- iġeddu regolarment it-tagħrif tagħhom

speċjalment dwar ir-regolamenti tas-saħħa

relevanti,

- jilħqu l-ħtiġiet imniżżla mill-awtorità

kompetenti biex jiżguraw l-funzjonament

tajjeb tan-network,

- jipprovdu

lis-sid

jew

lill-persuna

responsabbli għar-razzett it-tagħrif u l-

assistenza sabiex jittieħdu l-passi kollha biex

jiżguraw li jinżamm l-istatus tar-razzett,

partikolarment fuq il-bażi ta’ programmi

miftiehma ma’ l-awtorità kompetenti,

- jiżguraw konformità mal-ħtiġiet dwar -

1. l-identifikazzjoni u ċ-ċertifikazzjoni

tas-saħħa ta’ l-annimali tal-merhla, I-

annimali introdotti u dawk negozjati;

2. ir-rappurtar

obbligatorju

tal-mard

infettiv ta’ l-annimali u kull fattur ieħor

ta’ riskju għas-saħħa jew indukrar ta’ l-

annimali, u għas-saħħa tal-bniedem;

3. l-istabbilizzar mill-aktar fis possibbli

tal-kawża tal-mewt ta’ l-annimali u fejn

dawn għandhom jiġu konsenjati;

4. il-kondizzjonijiet iġeniċi tal-merħla u

tal-livestock production units

Iżda jekk il-funzjonament tajjeb tas-sistema jkun hekk

jitlob, kull Stat Membru jista’ jillimita r-

responsabbiltà tal-veterinarji għal għadd speċifiku ta’

rziezet jew għal żona ġeografika speċifika

Iżda wkoll l-awtorità kompetenti għandha tagħmel listi

ta’ veterinarji approvati u ta’ l-irziezet approvati li

jkunu qed jipparteċipaw fin-network. Jekk l-awtorità

kompeteni ssib illi parteċipant fin-network ma għadux

jilħaq il-kondizzjonijiet stabbiliti hawn qabel, huwa

għandu jissospendi jew jirtira l-approvazzjoni,

mingħajr preġudizzju għall-penalitajiet li jistgħu jiġu

applikati.

(ċ) Il-computer database irid ikollu ta’ l-inqas it-tagħrif li

F’ANNIMALI BOVINI U MAJJALI

ġej

(i)

għal kull annimal

- il-kodiċi uniku jew kodiċijiet uniċi ta’

identifikazzjoni,

fir-rigward

tal-każijiet

spjegati fl-Artikoli 4(1), 4b, 4ċ(1) u 4d tar-

Regolament (KE) Nru 1760/2000 tal-

Parlament u tal-Kunsill;

- id-data tat-twelid;

- is-sess;

- ir-razza jew il-kulur;

- il-kodiċi ta’ identifikazzjoni tal-omm jew,

fil-każ ta’ annimal impurtat minn pajjiż terz,

il-kodiċi uniku ta’ identifikazzjoni tal-mezz

individwali ta’ identifikazzjoni allokat lill-

annimal mill-Istat Membru tad-destinazzjoni

skont ir-Regolament (KE) Nru 1760/2000;

- in-numru

ta’

identifikazzjoni

tal-

istabbiliment fejn twieled;

- in-numri

ta’

identifikazzjoni

tal-

istabbilimenti kollha fejn inżamm l-annimal

u d-dati ta’ kull bidla ta’ stabbiliment;

- id-data tal-mewt jew tal-qtil;

- it-tip ta’ identifikatur elettroniku, jekk

applikat lill-annimal.

(ii) Għal kull razzett -

- in-numru ta’ identifikazzjoni li jikkonsisti

f’mhux aktar minn 12-il ċifra (apparti mill-

kodiċi tal-pajjiż);

- l-isem u l-indirizz tal-possessur.

(iii) Id-database għandha tkun kapaċi tissupplixxi

f’kull ħin dawn il-partikolaritajiet li ġejjin

- in-numru ta’ identifikazzjoni ta’ l-annimali

kollha ta’ l-ispeċi bovina preżenti fir-razzett,

jew fil-każ ta’ gruppi ta’ annimali ta’ l-ispeċi

porċina, in-numru ta’ reġistrazzjoni tar-

razzett ta’ oriġini jew tal-merħla ta’ oriġini u

fejn applikabbli n-numru taċ-ċertifikat tas-

saħħa,

- lista tal-bidliet kollha tar-razzett għal kull

annimal ta’ l-ispeċi bovina, mir-razzett tat-

twelid, jew ir-razzett ta’ l-importazzjoni fil-

każ ta’ annimali impurtati minn pajjiżi terzi;

u fil-każ ta’ gruppi ta’ majjali n-numru ta’

reġistrazzjoni ta’ l-aħħar razzett jew l-aħħar

merħla u għall-annimali impurtati minn

pajjiżi terzi, ir-razzett ta’ importazzjoni

Iżda l-partikolaritajiet jinżammu fuq id-

database għal tliet snin konsekuttivi mill-

mewt ta’ l-annimal bovin jew sakemm

F’ANNIMALI BOVINI U MAJJALI

jgħaddu tliet snin konsekuttivi minn meta

jkun sar ir-record fil-każ ta’ records ta’

majjali. Madanakollu, il-punti 2, 3 u 4 biss

għandhom japplikaw għall-majjali.

(iv)

Sabiex tkun żgurata l-operazzjoni ta’ computer

databases nazzjonali li jikkonċernaw il-majjali,

regoli xierqa għall-applikazzjoni, li jinkludu l-

informazzjoni li għandha tkun imniżżla fid-

databases nazzjonali, għandhom jkunu adottati

skond il-proċedura mfassla fl-Artikolu 17 tad-

Direttiva tal-Kunsill ta’ l-Unjoni Ewropea 64/

432/KEE.

(4) Il-parteċipanti kollha fis-system surveillance network barra

minn dawk li hemm provdut dwarhom fis-subegolament (3)(a) u

(b) għandhom jkunu accountable lill-awtorità kompetenti. L-

awtorità kompetenti f ’kull pajjiż membru ser tkun responsabbli

biex jittwaqqaf in-network u għandhom jagħmlu kontrolli b’mod

regolari biex jiżguraw li jaħdmu b’mod tajjeb.

(5) Il-pajjiż membru li introduċa system surveillance network

kif imfassal fis-subregolament (3)(ċ), li kien jaħdem għall-inqas

għal tnax-il xahar, għandu japplika għand il-Kummissjoni biex tiġi

approvata taħt il-proċedura mfassla fl-artikolu 17 tad-Direttiva tal-

Kunsill ta’ l-Unjoni Ewropea 64/432/KEE

Iżda għal din ir-raġuni il-Kummissjoni Ewropea għandha

teżamina id-dokumentazzjoni mibgħuta mill-pajjiżi membri.

(6) Meta l-awtorità kompetenti tkun implimentat fil-

ġurisdizzjoni tagħha kollha system surveillance network hekk kif

imfassla f ’dan ir-regolament, għandhom jawtorizzaw biex ma

japplikawx id-disposizzjonijiet imsemmija fir-regolament 3(2)(a),

għall-annimali msemmija f’dawn ir-regoli fit-territorju tagħhom.

(7) Il-finazjament tas-system surveillance network għandu jiġi

kopert skond il-framework tar-revisjoni ta’ l-Iskeda B tad-Direttiva

tal-Kunsill ta’ l-Unjoni Ewropea 85/73/KEE u skond id-

disposizzjonijiet imfassla fl-Artikolu 8 tad-Direttiva tal-Kunsill ta’

l-Unjoni Ewropea 96/43/KE.

(1) Kull ksur ta’ dawn ir-regolamenti kemm jekk minn

persuna naturali jew ġuridika għandu jkun penalizzat bil-miżuri

speċifiċi adatti mniżżla fil-leġislazzjoni ta’ Malta.

(2) Jekk ikun konfermat li mal-wasla f’Malta ma jkunux qed

jiġu jew ma jkunux ġew segwiti d-disposizzjonijiet ta’ dawn ir-

regolamenti, l-awtorità kompetenti għandha tieħu l-miżuri kollha

xierqa biex tħares is-saħħa ta’ l-annimali u tipprevjeni t-tixrid tal-

marda. Skond iċ-ċirkostanzi, azzjoni bħal din mill-awtorità

kompetenti tista’ tikkonsisti fit-teħid ta’ miżuri meħtieġa biex -

(a) jirranġaw għall-vjaġġ biex ikun komplut jew l-

annimali jiġu ritornati lejn il-post minn fejn ikunu

telqu bir-rotta l-aktar diretta, kemm-il darba din l-

azzjoni ma tkomplix tipperikola s-saħħa u l-indukrar

F’ANNIMALI BOVINI U MAJJALI

ta’ l-annimali;

(b) jirranġaw biex l-annimali jinżammu f’akkomodazzjoni

xierqa b’kura xierqa fil-każ li l-vjaġġ ikun interrott;

(ċ) jirranġaw għall-qtil ta’ l-annimali. Id-destinazzjoni u

l-użu ta’ dawn l-annimali wara l-qtil għandu jkun

regolat -

(i)

skond id-disposizzjonijiet mniżżla taħt id-

Direttiva tal-Kunsill ta’ l-Unjoni Ewropea 64/

433/KEE dwar il-laħam frisk, jew

(ii) skond id-disposizzjonijiet mniżżla fid-Direttiva

ta’ l-Unjoni Ewropea 90/667/KEE fejn l-istatus

ta’ saħħa ta’ l-annimali ma tistax tiġi stabbilita

jew fejn ikun possibli li jkun hemm riskju għas-

saħħa ta’ l-annimali u għas-saħħa pubblika.

Madankollu, fejn d-disposizzjonijiet tad-

Direttiva ta’ l-Unjoni Ewropea 90/667/KEE

għandha tapplika, jista’ jingħata perjodu ta’

regolarizzazzjoni lis-sid jew lill-aġent tiegħu

qabel ma dik il-possibilità finali tiġi invokata.

F’dak

il-każ

għandhom

japplikaw

id-

disposizzjonijiet tas-subregolament (3).

(3) L-awtorità kompetenti għandha tinnotifika minnufih lill-

awtorità kompetenti ta’ l-Istat Membru ta’ oriġini dwar xi ksur ta’

dawn ir-regolamenti. Skond id-disposizzjonijiet stabbiliti fid-

Direttiva tal-Kunsill ta’ l-Unjoni Ewropea 89/608/KEE, l-awtorità

kompetenti għandha tipprovdi assistenza reċiproka lill-Istat

Membru l-ieħor fl-applikazzjoni ta’ dawn ir-regolamenti sabiex

ikun żgurat, b’mod partikolari, li d-disposizzjonijiet mniżżla taħt

dawn ir-regolamenti jkunu qegħdin jiġu segwiti.

(4) Dan ir-regolament m’għandux jolqot regolamenti oħra ta’

Malta li japplikaw għal sanzjonijiet penali.

Sakemm tkun pendenti l-introduzzjoni f’Malta ta’ sistema

ta’ network ta’ sorveljanza approvata, għandha titħaddem b’mod

komplut sa mhux aktar tard mill-31 ta’ Diċembru 2002, computer

database li tkun konformi mad-disposizzjonijiet imniżżla fir-

regolament 14

Iżda f’dak li jirrigwarda l-moviment ta’ meta jikkonċerna l-

majjali, għandu jkun hemm mdaħħal fid-database għal kull

movement ta’ majjali. Dan id-dħul fid-database għandu jkun fih

mill-anqas dan li ġej

(i)

l-għadd ta’ majjali li jkun qed jiġi mċaqlaq,

(ii) in-numru ta’ identifikazzjoni tar-razzett jew tal-merħla

li titlaq,

(iii) in-numru ta’ identifikazzjoni tar-razzett jew tal-merħla

li tasal,

(iv) id-dati tat-tluq u l-wasla.

L-awtorità kompetetni għandha tiżgura illi r-reġistrazzjoni

tal-movimenti tal-majjali għandha tkun kompletament operattiva

F’ANNIMALI BOVINI U MAJJALI

mhux aktar tard mill-31 ta’ Diċembru 2003.

14. (1) The competent authority may carry out a system of

surveillance network. The surveillance network system must

comprise at least the following elements

(i)

the herds;

(ii) the owner or any other natural or legal person

responsible for the holding;

(iii) the approved veterinarian or the official veterinarian

responsible for the holding;

(iv) the competent authority of Malta;

(v) the official veterinary diagnostic or any other

laboratory approved by the competent authority;

(vi) a computer database

P r o v i d e d t h a t o ff i c i a l v e t e r i n a r i a n s f o r t h e s l a u g h t e r i n g

establishments and approved assembly centres will be associated

with the network system.

(2) The main objectives of the surveillance network system are

to make the official classification of holdings, to maintain such

classification by regular inspection, to collect epidemiological data

and to carry out disease monitoring so as to ensure compliance with

all the provisions of these regulations and other regulations in

respect of health restrictions

Provided that this surveillance network system shall be

mandatory on all holdings operating such a system in the territory

of Malta. However, the competent authority may authorize the

establishment of such a network on part of the territory made up of

one or several adjacent regions. Where this derogation is accorded,

animal movements to that part of the territory from other regions

which are not part of the network system shall be subject to the

provisions of these regulations

Provided further that the competent authority shall lay

down the obligations and rights incumbent upon the approved

veterinarians, the persons responsible for the holdings or their

owners and any other participants in the system including the

persons responsible for issuing health certificates.

(3) The competent authority shall ensure that the obligations

referred to in subregulations (1) and (2) at least include the

following

(a) Every owner of or person responsible for a holding

must -

(i)

secure, by contract or legal instrument, the

services of a veterinarian approved by the

competent authority;

(ii) immediately call in the approved veterinarian for

the holding when he suspects the occurrence of

an infectious disease or of any notifiable

disease;

(iii) notify the approved veterinarian of all arrivals of

animals on his holding;

(iv) isolate the animals before introducing them into

his holding to enable the approved veterinarian

to check, where appropriate by means of the

required tests, whether the holding’s status may

be maintained.

(b) The approved veterinarians shall be under the control

of the competent authority and must comply with the

following requirements

(i)

meet the conditions for pursuing the veterinary

profession;

(ii) have no financial interest or family links with

the owner of or person responsible for the

holding;

(iii) possess particular knowledge in the field of

animal health as it applies to animals of the

species concerned. This means that they must -

- regularly update their knowledge, especially

as regards the relevant health regulations;

- meet the requirements laid down by the

competent authority to ensure the proper

functioning of the network

- provide the owner of or person responsible

for the holding with information and

assistance in order that all steps are taken to

ensure that the holding’s status is

maintained, particularly on the basis of

programmes agreed with the competent

authority,

- ensure compliance with the requirements

concerning -

1. the identification and health certification

of the animals of the herd, the animals

introduced and those traded;

2. compulsory reporting of infectious

animal diseases and any other risk factor

for animal health or welfare, and for

human health;

3. establishing as far as possible the cause

of death of animals and where they are

to be consigned;

4. the hygiene conditions of the herd and of

the livestock production units

Provided that if the proper functioning of the system

so requires, each Member State may limit the

veterinarians’ responsibility to a specific number of

holdings or to a specific geographical area

Provided further that the competent authority shall

draw up lists of approved veterinarians and of the

approved holdings participating in the network. If the

competent authority finds that a participant in the

network no longer fulfils the conditions set out above,

it shall suspend or withdraw approval, without

prejudice to any penalties that may be applied.

(c) The computer database must contain at least the

following information

(i)

for each animal

- the unique identification code or codes, as

regards the cases set out in Articles 4(1), 4b,

4c(1) and 4d of Regulation (EC) No 1760/

2000 of the European Parliament and of the

Council;

- date of birth;

- sex;

- breed or colour of coat;

- identification code of the mother or, in the

case of an animal imported from a third

country, the unique identification code of the

individual means of identification allocated

to the animal by the Member State of

destination in accordance with Regulation

(EC) No 1760/2000;

- identification number of the holding where

born;

- identification numbers of all holdings where

the animal has been kept and the dates of

each change of holding;

- date of death or slaughter;

- the type of electronic identifier, if applied to

the animal.

(ii) for each holding -

- an identification number consisting of not

more than 12 figures (apart from the country

code);

- name and address of the holder.

(iii) the database must be able to supply the

following particulars at any time -

- the identification number of all animals of

the bovine species present on a holding, or in

the case of groups of animals of the porcine

species, the registration number of the

holding of origin or herd of origin and the

number of the health certificate where

applicable,

-

a list of all changes of holding for each

animal of the bovine species starting from

the holding of birth, or the holding of

importation in the case of animals imported

from third countries; and for groups of pigs

the registration number of the last holding or

last herd and for imported animals from third

countries the holding of importation

Provided that these particulars will be held

on the database until three consecutive years

have elapsed since the death of the bovine

animal or until three consecutive years have

elapsed since the record was made in the

case of records for pigs. However, only

points 2, 3 and 4 shall be applicable to

porcine animals;

(iv)

in order to ensure the operation of the national

computer databases concerning porcine animals,

appropriate regulations of application, including

the information that the national databases must

contain, shall be adopted in accordance with the

procedure laid down in Article 17 of the

European Union Council Directive 64/432/EEC.

(4) All participants in the surveillance network other than those

provided for in subregulation (3)(a) and (b) shall be accountable to

the competent authority. The competent authority in each Member

State shall be responsible for setting up the network and shall carry

out regular checks to ensure that it operates properly.

(5) Member States which introduce a system of surveillance

networks as outlined in subregulation (3)(c), operational for a

period of at least twelve months, shall apply to the Commission to

have it approved under the procedure provided for in regulation 17

Provided that for this purpose the European Commission

shall examine documentation submitted by Member States.

(6) When the competent authority has implemented throughout

its jurisdiction a recognized surveillance network system as laid

down in this regulation it shall be authorized not to apply the

provision referred to in regulation 3(2)(a), second indent, to animal

movements referred to by this regulation within their own territory.

(7) The financing of the surveillance network system will be

covered within the framework of the revision of Annex B to

European Union Council Directive 85/73/EEC in accordance with

the provisions laid down in Article 8 of European Union Council

Directive 96/43/EC.

15. (1) Any infringement of these regulations whether by a

natural or a legal person shall be penalised by the appropriate

specific measures laid down in the Maltese legislation.

(2) If it is confirmed that at the arrival in Malta the provisions

of these regulations are not or have not been complied with, the

c om p e te nt a ut ho r it y s h a ll t a k e al l app r op r iat e m e a s u r e s t o

safeguard animal health and to prevent the spread of disease.

Depending on the circumstances, such action by the competent

authority may consist of taking the measures required to -

(a) arrange for the journey to be completed or the animals

returned to their place of departure by the most direct

route, providing this course of action would not further

jeopardise the health or welfare of the animals;

(b) arrange for the animals to be held in suitable

accommodation with appropriate care in the event of

interruption of the journey;

(c) arrange for the slaughter of the animals. The

destination and use of such animals after slaughter

shall be regulated -

(i)

in accordance with the provisions of European

Union Council Directive 64/433/EEC on fresh

meat; or

(ii) in accordance with the provisions of the

European Union Council Directive 90/667/EEC

where the health status of the animals cannot be

established or where they are liable to be a risk

to animal health or public health. However,

where the provisions of European Union Council

Directive 90/667/EEC should apply, a

regularization period may be accorded to the

owner or his agent before that final possibility is

invoked. In that case, the provisions of

subregulation (3) shall apply;

(3) The competent authority shall immediately notity the

c o m p e t e n t a u t h o r i t y o f t h e M e m b e r St a t e o f o r i g i n o n t h e

e sta bl i shm e nt of an y i nfri ng em e nt of th ese r e gu l ati o ns . In

accordance with the provisions established by European Union

Council Directive 89/608/EEC, the competent authority shall

provide mutual assistance to one another Member State in the

application of these regulations in order to ensure, in particular,

compliance with the provisions laid down in this regulation.

(4) This regulation shall not affect other national regulations

applicable to penal sanctions.

16. (1) Pending the introduction in Malta of an approved

surveillance network system a computer database complying with

the provisions laid down in regulation 14 shall be fully operational

for bovine animals on the 31 December 2002 at the latest

Provided that with regards to porcine animals, there shall

be an entry in the database for each separate movement of porcine

animals. The entry shall comprise at least the following

(i)

the number of porcine animals being moved,

(ii) the identification number of the holding or herd of

departure,

(iii) the identification number of the holding or herd of

arrival, and

(iv) the departure and arrivals dates.

The recording of all movements of porcine animals shall be

fully operational on the 31 December 2003 at the latest.

17. A contract may be established between the competent

authority of Malta and the laboratories or Institutes listed in the

Annex B, Annex C, Annex D, chapter II of European Union

Council Directive 64/432/EEC and Annex III of European Union

Commission Decision 2001/618/EC, for the purpose of the tasks

indicated in the relevant Annexes.

The competent authority shall ensure that the regulations

laid down in the European Union Council Directive 90/425/EEC

shall apply in particular to checks at origin, to the organization of,

and follow-up to, the checks to be carried out by the country of

destination, and to the safeguard measures to be implemented.