Community Acts, Rules 2009

L.N. 351 of 2009

MALTA VETERINARY SERVICES ACT

(CAP. 437 )

Animal Health Requirements Governing Trade and Imports

into the Community of Animals, Semen, Ova and Embryos not

Subject to Animal Health Requirements laid down in Specific

Community Acts, Rules 2009

IN EXERCISE of the powers conferred by article 10 of the

Veterinary Services Act, the Minister for Resources and Rural Affairs

after consultation with the Minister for Finance, the Economy and

Investment and after having consulted the Veterinary Services

Authority, has made the following rules:-

(1) The title of these rules is Animal Health Requirements

Governing Trade and Imports into the Community of Animals,

Semen, Ova and Embryos not Subject to Animal Health Requirements

laid down in Specific Community Acts, Rules 2009.

(2) The scope of these rules is to transpose Directive

92/65/EEC laying down animal health requirements governing

trade and imports into the community of animals, semen, ova and

embryos not subject to animal health requirements laid down in

specific community acts and shall apply without prejudice to the

provisions adopted pursuant to other regulations and community

rules which may apply in this regard and without prejudice to other

national rules governing pet animals.

(3) These rules are being made for the safeguarding of

the public interest and public safety. Any requirements and safeguard

measures contained therein including those relating to authorisations

are made for overriding reasons relating to public interest.

(4) These rules shall come into force on the 7th

December, 2009.

Regolamenti 2(2) u 13(1)

MARD NOTIFIKABBLI FIL-KUNTEST TA’ DAWN IR-REGOLI ( a )

Mard

Spei konentrata

Marda ta’ Newcastle, influwenza ta’

Gasafar

l-gasafar

Psittacosis

Psittacidae

Foulbrood Amerikana

Naal

Marda ta’ l-ilsien u d-dwiefer

Ruminanti

Bucellosis (Bucella ssp.)

Tuberculosis (Tuberkuloi)

Marda klassika tal-qieqe

Suidae

Marda Afrikana tal-qieqe

Marda ta’ l-ilsien u d-dwiefer

Marda tar-rabja ( b )

L-ispei kollha suxxettibbli

( a ) Mingajr preudizzju gall-mard notifikabbli li hemm provvediment dwaru

fl-Anness I tad-Direttiva 82/894/KEE.

( b ) Bi qbil ma’ l-Artikolu 2 tad-Direttiva 89/455/KEE.

(1) Unless otherwise provided in these rules, the

definitions prescribed in the Act shall continue to apply and the

definitions, other than those of approved centres and bodies,

contained in in any other law or regulation governing trade shall

mutatis mutandis apply, unless they are inconsistent with these

rules.

(2) For the purpose of these rules and unless the context

otherwise requires

B

“the Act” means the Veterinary Services Act;

“animals” means specimens of animal species and shall

not include such animals as referred to in other community

legislation concerning animal health conditions governing

intra-Community trade, and the movement and imports from

third countries of animals and products of animal origin,

animal health conditions governing the placing on the market

of aquaculture and non-aquaculture animals and products as

well as those referred to in legislation concerning animal health

conditions for the production and the placing on the market of

fishery products and live products;

“authorisation” means any authorisation granted under

these rules and in relation to authorised providers and services

means a permit, licence, warrant, appointment, concession

or any decision concerning access to a service activity or the

exercise thereof;

“authorised provider” means and includes any person

who is a trader or importer in terms of these rules and who

is in possession of an authorisation issued in his favour by

the Department of Trade to import and trade in animals and

products of animal origin subject to trade from a Member State

or third country to Malta;

“approved body, institute or centre” means any permanent,

geographically limited establishment, approved in accordance

with rule 13 of these rules, where one or more species of animal

are habitually kept or bred, whether or not for commercial ends,

and exclusively for one or more of the following purposes

(a)

display of the animals and education of the

public;

(b)

conservation of the species; and, or

(c) basic or applied scientific research or breeding

of animals for the purposes of such research;

“the Community” means the Community of the European

Union;

“competent Authority” means the Veterinary Services

Authority as established by the Act;

“final consumer” means means any natural or legal person

purchasing animals and animal products subject to trade for

her own use and not for resale or transfer purposes;

“health certificate or commercial document” means a

certificate properly issued by the competent Authority as an

appropriate means of guaranteeing and monitoring compliance

as regards animals and products of animal origin subject to trade

with animal health requirements and any other requirements

contained in these rules;

“importer” means a person who in terms of an authorisation

issued in his favour by the Department of Trade is authorised

to import in Malta animals and products of animal origin

transported from any third country or other Member State in

terms of these rules;

“Member State” means a State which is a member to the

European Union;

“monitoring program” means a control or monitoring

programme drawn up by the competent Authority for the

purpose of keeping of records of animals and products of

animal of origin subject to trade with regard to the outbreak of

notifiable diseases and of diseases referred to in Schedule B to

these rules;

“notifiable diseases” means the diseases listed in Schedule

A to these rules;

“official veterinarian” means a veterinarian of the

approved body, institute or centre of origin appointed and

approved by the competent Authority who, for the purpose

of these rules shall be responsible to guarantee the animals’

health;

“overriding reasons relating to public interest” means

reasons recognised as such in case law of the European

Courts of Justice and which reasons present a justification for

the issue of an authorisation and, or the issue of a condition

thereto and, or to any other policy decision taken in terms of

such authorisation, when such authorisation, and, or condition

and, or policy decision thereto could not have been issued or

taken under normal circumstances but for such overriding

reasons relating to public interest which include the following

grounds

(a) public policy, public security, public safety

and public health, provided that, these grounds shall be

interpreted within the meaning of Article 46 and Article

55 of the Treaty

(b) the maintenance of order in society;

(c) social policy objectives;

(d) the protection of the recipients of services;

(e) consumer protection;

(f) the prevention of fraud;

(g) the protection of the environment;

“placing on the market” shall have the same meaning

provided for in the Act;

“recipient” means any natural person who is a national

of a Member State, who benefits from rights conferred upon

him by community acts or any legal person established in

a Member State, who for professional or non-professional

purposes, uses, or wishes to use a service against non-economic

considerations;

“service activity” means any self-employed activity

performed for economic considerations;

“third country” means a country which is not a member

of the European Community;

“trade” means for the purpose of these rules, trade

between Member States in animals and products, a business

or occupation to make profit or gain, particularly in retail or

wholesale sales and includes dealings in a particular business

activity;

“the Treaty” means the treaty as established by the

European Community;

“undertaking” shall have the same meaning as provided

for under the Competition Act; and

“veterinary checks” means any physical check and, or

administrative formality, verification, control, monitoring,

organisation of checks and any follow-up thereto with regard

to animals and products of animal origin made by official

veterinarians, and which shall apply in particular, to checks

at the point of origin and checks carried out on arrival by the

Member State of destination to guarantee animals’ health and

to safeguard measures to be implemented in this regard, in

order to ensure conformity with animal health requirements

governing trade and which are intended for the protection,

direct or otherwise, of public and, or animal health.

Regolamenti 2(2), 4(b) u 13(1)

LISTA TA’ MARD LI DWARU L-PROGRAMMI NAZZJONALI JISTGU

JKUNU RIKONOXXUTI PERMEZZ TA’ DAWN IR-REGOLI

Enterite virali

Mard Alewzjan

Foulbrood Ewropew

Varroasus u acariasis

Xadini u felidi

Tuberkuloi

Ruminanti

Tuberkuloi

Logomorfi

Myxomatosis

Mard emoraiku virali

Tularaemia

B

(1) The competent Authority shall ensure that the trade

referred to in rule 1(2) hereof, is not prohibited or restricted for

animal health reasons other than those arising from the application

of these rules or from national legislation, and in particular any

safeguard measures taken in this regard.

(2) The competent Authority shall ensure that the

veterinary checks carried out on products of animal origin, which

are intended for trade, are no longer carried out at frontiers but are

carried out in accordance with Directive 89/662/EEC concerning

veterinary checks in intra-Community trade with a view to the

completion of the internal market, which shall apply in particular to

checks at the place of origin, to the organisation of and follow-up to

the checks to be carried out by the Member State of destination, and

to the protective measures to be implemented in this regard.

(3) The provisions applicable to trade, shall in particular

be applied by the competent Authority to

(a) ensure that the placing on the market of such animals

and their products constitute a considerable source of income

for part of the farming population;

(b) ensure the rational development in this sector and

increase productivity, as well as to ensure that animal health

rules for the animals and their products are laid down at

national law level;

(c) ensure that animal health rules are adopted for the

placing on the market of animals and products of animal origin

which are not covered by other community rules which are

already into force;

(d) ensure that with regard to the organisation of checks

and the follow-up thereto, as well as the safeguard measures

to be implemented, reference is made to the general rules

concerning veterinary checks applicable to national trade in

certain live animals and products with a view to the completion

of the internal market;

(e) ensure, unless otherwise provided in these rules, that

trade in animals and products of animal origin are liberalised,

without prejudice to recourse to any possible safeguard

measures;

(f) ensure, taking into account the significant risk of the

spread of diseases to which animals are exposed, that for certain

animals and products of animal origin, specific requirements

are imposed when such animals and products of animal origin

are placed on the market for the purposes of trade, particularly

when intended for regions with a high health status;

(g) ensure that a health certificate is properly issued

which is the most appropriate means of guaranteeing and

monitoring compliance with the requirements of these rules;

and

(h) ensure that provision is made for a procedure

establishing close co-operation and mutual assistance with

other authorities established in other Member States.

(4) The competent Authority shall establish and

apply all such necessary administrative measures according to the

requirements of these rules to ensure that there is no breach of

these rules and also to reduce the risk for final consumers and any

additional risk to animals and to the environment. The measures

established in these rules shall conform with and be in accordance

with the requirements of the food chain and animal health.

(5) These measures shall include the direct confiscation

of the product, the suspension of the activities carried out by the

authorised provider when these are creating a risk to final consumers

and to the environment, and the application of an administrative

penalty in terms of article 61 of the Act.

Regolament 13 (1) and (4)

KUNDIZZJONIJIET LI JIRREGOLAW APPROVAZZJONI TA’ KORPI,

ISTITUTI JEW ENTRI

1. Sabiex tkun mogtija l-approvazzjoni uffijali permezz tar-regola 13(2) ta’ dawn

ir-regoli, korp, istituti jew entru kif imfisser fir-regola 2(1)() gandu

(a) ikun kjarament demarkat u separat mill-ambjent ta’ madwaru;

(b) ikun jinstab f’distanza rajonevoli minn stabbilimenti agrikoli li l-istatus tas-

saa taghom jistgu jkunu mfixkla bil-preenza ta’ korp, istitut jew entru

approvat;

() ikun tat il-kontroll ta’ veterinarju ( 1 ) li jagmel monitora ta’ l-annimali, li

gandu jkun jista’ jinqabad, jinqafel u li jitqieged f’gaa f’kull in;

(d) li jkollu failitajiet adegwati ta’ kwarantina;

(e) ikollu wieed jew aktar bini fejn ikun jista’ jipprattika l-eami ta’ post-mortem;

(f) ikun ieles mill-mard imniel fi Skeda A u, f’dak li jirrigwarda l-mard kopert fil-

pajji ikkonernat bi programm, tal-mard imniel fi Skeda B;

(g) iomm aornati r-reistri li jindikaw

- in-numri ta’ annimali gal kull spei preenti fl-istabbiliment, b’informazzjoni dwar

l-etajiet taghom,

- in-numru ta’ annimali li jaslu fl-istabbiliment jew li jitilqu minnu, flimkien ma’

informazzjoni dwar it-trasport taghom u s-saa ta’ l-annimali,

- osservazzjonijiet magmula waqt il-perjodu ta’ kwarantina,

- ir-riultati ta’ eamijiet regolari ta’ l-eskrementi,

- ir-riultati tat-testijiet tad-demm jew xi proeduri dianjostii ora,

- kaijiet ta’ mard u, fejn xieraq, it-trattament mogti,

(1)

Responsabbli gal konformità minn urnata gal ora mal-tiiet ta’ dawn ir-regoli rigward is-saa

ta’ l-annimali.

B

- ir-riultati tad-dissezzjoni ta’ xi annimali li jmutu fl-istabbiliment, inklui dawk l-

annimali li jitwieldu mejtin;

(h) li jkollhom failitajiet gat-tneija xierqa ta’ l-isma ta’ annimali li jmutu minn

xi marda;

(i) ikunu tat monitora ta’ veterinarju uffijali li gandu jwettaq mill-anqas ew

verifiki tas-saa kull sena.

Verifiki tas-saa gandhom jinkludu mill-anqas

- ispezzjoni wada ta’ l-annimali kollha fl-istabbiliment,

- kampjuni rappreentattivi meuda mill-ispei kollha suxxettibbli gall-mard li

hemm referenza galihom fi Skedi A u B ( 2 ) jew is-sejba ta’ dan il-mard b’metodi

ora. Dawn il-kampjuni gandhom ikunu analizzati minn laboratorju approvat li

gandu jivverifika jekk ikollhom aenti tal-mard gal kull spei fi Skeda A.

Kampjuni jistgu jittiedu matul is-sena.

Ir-riultati tat-testijiet tal-laboratorju fuq il-kampjuni meuda matul il-verifiki tas-

saa jridu ma jkunu wrew l-ebda evidenza tal-patoeni f’dak il-ka;

- ir-reistri ta’ l-eami li gandhom jinammu.

2. Approvazzjoni gandha tinamm meta dawn il-tiijet ikunu miluqa

(a) l-annimali mijuba fl-istabbiliment iridu jkunu ejjin minn entru, istitut jew korp

approvat ieor;

(b) jekk annimali koperti bid-Direttiva 64/432/KEE jkunu mimuma f’entru, istitut

jew korp approvat, dawn jistgu jallu l-istabbiliment biss permezz ta’ kontroll

uffijali;

() verifiki tas-saa fi-entru, istitut jew korp approvat gandhom ikunu mwettqa

darbtejn fis-sena, bi qbil ma’ punt 1 (h) ta’ din l-Iskeda.

Kemm –il darba wieed minn dan il-mard ikun notifikabbli f’Malta.

B

(d) ir-riultati tat-testijiet tal-laboratorju fuq il-kampjun m’gandhom juru l-ebda

traa ta’ aenti tal-mard li hemm referenza galihom fi Skedi A u B ( 1 ) ;

(e) xi mwiet issuspettati jew il-preenza ta' xi sintomi ora li jissuerixxu li l-

annimali jkunu ew ikkontaminati b'wieed jew aktar mill-mard li hemm referenza

galihom fi Skedi A u B ( 1 ) gandhom ikunu nnotifikati mingajr dewmien lejn l-

awtorità kompetenti.

3. Tista’ tkun sospia l-approvazzjoni, restawrata jew imneija f’dawn i-irkostanzi

li ejjin

(a) meta notifika tingata fit-tifsira ta’ 2 (d) ta’ din l-Iskeda, l-awtorità kompetenti

gandha temporanjament tissospendi l-approvazzjoni ta-entru, korp jew istitut

approvat;

(b) kampjun meud minn annimal issospettat jintbagat lejn il-laboratorju approvat

biex isir test dwar il-preenza tal-patoeni f’dak il-ka. Ir-riultati tat-testijiet

gandhom immedjatament jintbagtu lill-awtorità kompetenti;

() meta d-dipartiment uffijali jkun ie infurmat b’suspetti rigward il-preenza ta’

wieed mill-mardiet li hemm referenza galihom fi Skedi A u B 1 , gandi jireaixxi,

fir-rigward tat-testijiet tal-laboratorju, l-eami epiotoloika, il-miuri li gandhom

jittiedu kontra l-mard u t-tneija ta’ l-approvazzjoni, daqslikieku l-mard kienet ie

nnotifikata, bi qbil mad-Direttiva li tirregola miuri f’dan il-razzett li gandhom

jittiedu kontra l-mard u l-kummer fl-annimali;

(d) meta r-riultati tat-test ma juru l-ebda tal-patoeni kkonernati, l-uffijal tad-

dipartiment gandu jera jgati l-approvazzjoni;

(e) il-korp, istitut jew entru mill-did ikun approvat biss meta, wara eradikazzjoni

tas-sorsi ta’ infezzjoni, il-kundizzjonijiet metiea f’punt 1 ta’ din l-Iskeda, bl-

eezzjoni ta’ punt 1 (f), ikunu mwettqa mill-did;

(f) l-awtorità kompetenti gandha tinforma lill-Kummissjoni bis-sospenzjoni, restawr

jew tneija ta’ l-approvazzjoni.

Kemm –il darba wieed minn dan il-mard ikun notifikabbli f’Malta.

B

The competent Authority shall take all necessary measures Measures to be

to ensure that, the animals referred to in rules 5 to 10 of these adopted by the

rules may without prejudice to rule 13 hereof and to the particular

provision of rule 15 of these rules, be subject to trade only if they

satisfy the conditions laid down in rules 5 to 10 hereof and that such

animals come from the holdings or businesses referred to in rule 12

(1) and (3) of these rules, and which are duly registered with the

Department of Trade and which undertakings shall

(a) have the animals held examined regularly in

accordance with animal health rules;

(b) notify the competent Authority, apart from the

outbreak of notifiable diseases, of the outbreak of the diseases

referred to in Schedule B to these rules for which the Authority

has drawn up a control or monitoring programme in this

regard;

(c) comply with the specific national measures to control

a disease, and which measures are of particular importance

to the competent Authority and are covered by a programme

drawn up by the competent Authority;

(d) place on the market for the purposes of trade only

animals which show no signs of disease and which come from

holdings or areas not subject to any ban on animal health

grounds, and with respect to animals not accompanied by a

health certificate or a commercial document provided for in rules

5 to 11 hereof, only animals accompanied by self-certification

by the trader, operator or authorised provider stating that the

animals in question do not at the time of dispatch show any

obvious signs of disease and that his holding is not subject to

any animal health restrictions; and

(e) comply with the requirements ensuring the welfare

of the animals held in terms of the Animals Welfare Act.

Regolament 11 (2) (a)(b)(c) u (3) (a) (b)

KAPITOLU I

I. 1. Kundizzjonijiet li jirregolaw l-approvazzjoni ta’ entri gall-bir tas-semen

entri gal bir ta’ semen gandhom

1. ikunu mqiegda tat is-supervijoni ta’ ‘veterinarju ta-entru’;

2. ikollhom bini differenti u fiikament separat gal

- akkomodazzjoni u l-isolament ta’ annimali,

- il-bir tas-semen,

- tindif u d-disinfettazzjoni tat-tagmir,

- il-proessar tas-semen,

- il-ana tas-semen;

3. ikun mibni jew mimum separat b’tali mod hekk li ma jallix xi kuntatt ma’

annimali l-barra mi-entru;

4. ikollu bini kif deskritt fi 2 li jkun failment imnaddaf u ddisinfettat,

II. Kundizzjonijiet gas-supervijoni ta’ entri tal-bir ta’ semen

entri gal bir ta’ semen gandhom

1. ikunu sorveljati biex ikun assigurat li annimali biss li s-semen taghom sejjer

ikunu mibur jinammu hemmhekk. Ida, annimali domestii ora jistgu jibqgu

f’dawn i-entri sakemm dawn ikunu jilqu l-kundizzjonijiet enerali metiea hawn

tat,

2. ikun hemm monitora taghom biex ikun assigurat li reistru jinamm li juri

- l-identità ta’ l-annimali preenti fi-entru,

- kull moviment ta’ annimali (li jidlu u jooru),

- il-verifiki magmula dwar is-saa,

- l-istorja tas-saa,

- id-destinazzjoni tas-semen,

- il-ana tas-semen;

B

3. ikunu spezzjonati mill-anqas darbtejn fis-sena minn veterinarju uffijali biex

jassigura li l-kundizzjonijiet dwar approvazzjoni u supervijoni jkunu miluqa;

4. ikollhom impjegati kompetenti li jkunu revew tari adegwat dwar it-teknika tad-

disinfettazzjoni u iene li jippermettu li t-tixrid tal-mard ikun evitat;

5. isir monitora taghom biex ikun assigurat li

- il-bir, proessar u ana tas-semen jitwettaq biss fil-bini molli gal dawk l-

iskopijiet,

- l-utensili kollha li jiu f’kuntatt mas-semen jew ma’ l-annimal donatur matul il-bir

jew proessar ikunu ddisinfettati kif xieraq jew steriliati qabel kull uu,

- xi reipjent gal ana jew trasport ta’ semen ikunu disinfettat jew steriliat qabel

kull uu;

6. ikunu guri li juaw

- prodotti ta’ oriini minn annimali li jkunu uati fil-proessar tas-semen (adittivi jew

dilwenti) li ma jkunu jippreentaw l-ebda riskju ta’ saa jew li jkunu gaddew minn

proessar preedenti biex ma jallux riskji bal dawn,

- aent krioeniku li ma jkunx preedentament uat gal prodotti ora ta’ oriini

minn annimal;

7. jassiguraw li l-kwalità ta’ kull semen hija adegwatament identifikabbli b’tali mod li

d-data tal-bir, ir-razza u l-identità ta’ l-annimal donatur tistà tkun stabbilita kif ukoll

l-isem ta-entru approvat li jkun gamel il-bir.

KAPITOLU II

Kundizzjonijiet applikabbli f’entri ta’ bir

tiiet f’dak li jirrigwarda l-ammissjoni ta’ donatur maskili

A. WIEMEL TAR-RAZZA

Dawk i-wiemel tar-razza biss, li gas-sodisfazzjon tal-veterinarju uffijali, jilqu il-

tiiet segwenti jistgu jintuaw gall-bir ta’ semen

1. iridu jkunu ta’ saa tajba fil-waqt tal-bir

B

2. gandhom jissodisfaw il-tiiet tad-Direttiva 90/426/KEE u jkunu ejjin minn

oqsma li wkoll jissodisfaw dawk il-tiiet;

3. matul is-60 jum ta’ qabel l-ewwel bir dawn jkunu gaddew mit-testijiet segwenti

mingajr riultati negattivi

(a) li jintebu b’xi anemija infettiva ta-wiemel, test ta’ agar-gel immunodiffusion,

magruf bala l-'Coggins test'

(b) li jinteba b’artheritis virali, test ta’ sero-neutralization (dilution < 1/4)

issupplementat, fil-ka ta’ riultat posittiv, minn eami viroloiku tas-semen totali

b’riultat negattiv;

() li jinteba b’metrotis kontajua ta-wiemel bl-isolament tal-mikrobu

Taylorella equigenitalis, mill-anqas test ta’ kampjuni meuda mill-urethra u mill-

fluwidu ta’ qabel l-ejakulazzjoni.

Ir-riultat ta’ dawn it-testijiet gandu jkun iertifikat minn laboratorju rikonoxxut

mill-awtorità kompetenti.

Matul il-perjodu msemmi fl-ewwel paragrafu ta’ 3 hawn qabel, u matul il-perjodu tal-

bir, wiemel tar-razza ma jistgux jitallew li jservu naturalment.

B. NGA U MOGO

1. Dawk in-nga u mogo biss minn entri jew oqsma, li gas-sodisfazzjon tal-

veterinarju uffijali, jilqu l-tiiet segwenti jistgu jintuaw gall-bir ta’ semen

(a) ikunu f’saithom fil-jum meta s-semen ikun mibur;

(b) ikunu jilqu l-tiiet metiea fl-Artikoli 4, 5 u 6 tad-Direttiva 91/68/KEE dwar

il-kummer intra-Komunitarju.

B’ieda, annimali donaturi gandhom ikunu gaddew minn, matul it-tletin jum ta’

qabel il-bir, b’riultati negattivi

- test biex jintebu b’brucellosis (B. melitensis) bi qbil ma’ l-Anness  tad-Direttiva

91/68/KEE,

- test gal epididymitis (B. ovis) kontajua bi qbil ma’ l-Anness D tad-Direttiva

91/68/KEE,

B

- test gal virus tal-marda Border;

() ikunu gaddew mit-testijiet relevanti jew verifiki ddisinjati biex jiggarantixxu

konformità mal-tiiet metiea f’(a) u (b) hawn qabel.

2. It-testijiet li hemm referenza galihom f’1. gandhom jitwettqu minn laboratorju

approvat mill-Istat Membru.

C. Jekk xi wieed mit-testijiet li hemm referenza galihom f’A jew B jirriultaw

poittivi, l-annimal gandu jkun iolat u s-semen mibur minn sa mill-aar test

negattiv ma jkunx jista’ jitqieged fis-suq. L-istess japplika gal semen mibur minn

annimali ora fir-razzett jew f’entru ta’ bir sa mid-data li fiha t-test poittiv ikun

ie mwettaq. Kummer ma jistax jera jibda sa kemm l-istatus tas-saa ta-entru

jkun ie stabbilit mill-did.

KAPITOLU III

tiiet applikabbli gal semen, ova u embrijuni

Semen, ova u embrijuni jridu jkunu ew mibura, ipproessati, masula u

ippreservati bi prodott bioloiku ieles minn mikro-organimi ajjin bi qbil mal-

prinipji segwenti

(a) il-asil ta’ ova u embrijuni irid jitwettaq bi qbil mar-regola 11 (3) ta’ dawn ir-

regoli. I-ona pelluida taghom gandha tibqa’ ntatta qabel u wara l-asil. Ova u

embrijuni biss minn wieed u l-istess donatur jistgu jkunu masula fl-istess waqt.

Wara l-asil, i-ona pelluida ta’ kull ovum jew embrijuni gandha tkun eaminata

matul il-wi kollu tagha tat ingrandiment ta’ mill-anqas 50 u tkun iertifikata

bala li tkun intatta u ielsa minn xi materjal barrani li jkun imwaal magha;

(b) il-medja u s-soluzzjoni uata gal bir, iffriar u konservazzjoni ta’ ova u

embrijuni gandhom ikunu sterilizzati skond il-metodi approvati kif metiea fir-

regola 11 (3) u ttrattati b’tali mod li jibqgu sterili. Antibiotii gandhom ikunu

mijuda mal-medja ta’ bir, asil u konservazzjoni;

B

() il-materjali kollha uati gal bir, trattar, asil, iffriar u konservazzjoni ta’ ova u

embrijuni gandhom ikunu sterilizzati qabel l-uu;

(d) iridu jkunu ew suetti, bi qbil ma’ l-Artikolu 11 (2), gal testijiet addizzjonali,

partikolarment tal-likwidi tal-bir jew asil, hekk li jkun stabbilit li l-ebda patoeni

ma jkunu preenti;

(e) gandhom jinammu f’reipjenti sterili

- ikun fihom biss prodotti minn donatur wieed maskili jew femminili,

- ikunu ssiillati fil-waqt ta’ l-iffriar f’alkool jew nitroenu likwidu frisk, u

b’tikketta,

u jkunu mqiegda f’kontenituri steriliati b’nitroenu likwidu li ma jippreenta l-

ebda riskju ta’ kontaminazzjoni gall-prodotti;

(f) iridu jkunu mauna f’kundizzjonijiet approvati gal perjodu minimu ta’ 30 jum

qabel ma jkunu mibguta;

(g) gandhom ikunu ttrasportati f’vaetti li jkunu ew imnaddfa, disinfettati jew

sterilizzati qabel l-uu.

KAPITOLU IV

Donaturi femminili

Femminili jistgu jkunu uati gal bir ta’ embrijuni jew ova biss jekk jilqu, gas-

sodisfazjon tal-veterinarju uffijali, il-tiiet tad-Direttivi relevanti dwar kummer

intra-Komunitarju f’annimali ajjin gat-tnissil u produzzjoni tar-razza kkonernata,

jiifieri Direttiva 64/432/KEE gal majjali, Direttiva 90/426/KEE gal ekwidi u

Direttiva 91/68/KEE gal annimali ovini u kaprini li jkunu ejjin minn merliet li

wkoll jilqu mill-imsemmija tiiet.

B

The competent Authority shall ensure that trade in apes

(simiae and prosimiae) is restricted solely to animals consigned

from and to an approved body, institute or centre approved by

the competent Authority in terms of rule 10 hereof, and that such

animals are accompanied by a veterinary certificate corresponding

to the specimen in Schedule E to these rules, the declaration in which

shall be completed by the official veterinarian of the approved body,

institute or centre of origin to guarantee the animals’ health.

Regolamenti 6 (1) (f) u 10 (2) (a) (v)

ERTIFIKAT

KOMUNITA’ EWROPEA

ERTIFIKAT TAS-SAA

1.Konsenjatur (isem w indirizz si)

ORIINALI ( a )

Nru

2. Stat Membru ta’ oriini

3.Min jirievi (isem u indirizz si)

4. AWTORITA’ KOMPETENTI

5.Indirizz

-

ta’ l-akkwist ta’ oriini jew ta’

korp, istitut jew entru ta’ oriini

uffijalment approvat ( b )

-

ta’ l-akkwist jew tan-negozjant ta’

destinazzjoni jew ta’ korp, istitut

jew entru ta’ destinazzjoni

uffijalment approvat ( b )

6. Lokalita’ tat-tagbija

7. Mezzi tat-trasport

B

8. Spei

9. Numru ta’ annimali/xehdiet/jew irejjen (b’attendants) ( b )

10. Identifikazzjoni tal-lott

11. ATTESTAZZJONI (  )

Magmula fi ……………… nhar il-………………

Firma

Isem f’ittri kapitali

Titolu u poizzjoni

( a ) ertifikat separat gandu jkun provdut gal kull konsenja u l-oriinali gandha

tintbagat flimkien mal-konsenja sad-destinazzjoni finali, li l-perjodu ta’ validita’

tagha huwa ta’ 10 jiem.

( b ) assar kif xieraq.

(  ) Imla skond l-Artikoli 5 sa 11 tad-Direttiva 92/65/KEE fl-24 siega qabel ma

l-annimali jkunu mgobbija.

B

Dikjarazzjoni biex timtela skond regola 6 (1) (f)

1. Jiena, li hawn tat iffirmajt (uffijal veterinarju) niertifika li r-ruminant/suida 1

apparti minn dak kopert bid-Direttiva 64/432/KEE

(a) li jappartjeni gall-ispei…;

(b) filwaqt ta’ l-eami, ma jurix xi sinjal kliniku ta’ xi mard li galiex huwa suxxettibbli;

() ej minn merla/razzett li uffijalment huwa ieles minn tuberkoloi, uffijalment

ieles mill-bruelloi jew minn merla/razzett li ma humiex suetti gar-restrizzjonijiet

tal-marda tal-nieer jew minn razzett fejn kien suett b’riultati negattivi gat-testijiet

metiea fir-regola 6 (1) (f) ta’ dawn ir-regoli.

assar kif ikun japplika.

Dikjarazzjoni biex timtela skond regola 10 (2) (a) (v)

Jiena, li hawn tat iffirmajt… niertifika li l-qtates/klieb 1 koperti b’dan i-ertifikat

jissodisfaw il-tiiet tar-regola 10 (2) (a) (v) ta’ dawn ir-regoli u li huma ejjin minn

razzett li fih l-ebda ka ta’ marda tar-rabja ma kien ie rreistrat matul dawn l-aar sitt

xhur.

assar kif ikun japplika.

(1) The competent Authority shall ensure that ungulates

of species are subject to trade only if generally

(a) they are identified in accordance with rules

established by Community law;

(b) they are not intended for slaughter under a

programme for the eradication of an infectious disease;

(c) they have not been vaccinated against foot-and-

mouth disease and satisfy the relevant health requirements of

other laws and regulations established by the Community;

(d) they come from a holding which is not the subject

of animal health measures, particularly those taken under such

regulations introducing Community measures for the control of

classical swine fever and have been kept therein permanently

since birth or for the last thirty days before dispatch;

(e) if imported, they come from a third country included

in a column entitled ‘other ungulates’ to be inserted in the list

provided in terms of such regulations on health and veterinary

inspection problems upon importation of bovine animals and

swine and fresh meat from third countries; and meet specific

animal health conditions, which are at least equivalent to the

requirements of this rule; and

(f) they are accompanied by a certificate corresponding

to the specimen given in terms of the declaration laid down in

Schedule E to these rules.

(2) The competent Authority shall ensure that ruminants

of species are subject to trade only if

(a) they come from an officially tuberculosis-free and

officially brucellosis-free herd in accordance with community

rules and satisfy, as regards animal health rules, the relevant

requirements laid down for the bovine species; and

(b) when they do not come from a herd meeting the

conditions laid down in paragraph (a), they come from a

holding in which no case of brucellosis or tubercolosis has

been recorded in the 42 days preceding loading of the animals

and in which the ruminants have, in the 30 days prior to their

dispatch, undergone with negative results

(i) a tuberculosis reaction test; and

(ii) a test designed to show the absence of

antibodies to brucellosis.

(3) The competent Authority shall ensure that suidae of

species are subject to trade only if

(a) they have not come from an area which is the

subject of prohibition measures associated with the presence

of African swine fever;

(b) they come from a holding which is not subject to

any restrictions as a result of classical swine fever;

(c) they come from a brucellosis-free holding and

satisfy the relevant animal health requirements in terms of

these rules; and

(d) when they do not come from a herd meeting the

conditions set out in paragraph (c), they have, in the 30 days

prior to their dispatch, undergone with negative results a test

designed to show the absence of antibodies to brucellosis.

(4) The testing requirements referred to in this rule and

their criteria shall be established in accordance with the procedure

concerning veterinary checks in terms of rule 3(2) of these rules.

Without prejudice to the aforementioned sub-rules, other provisions

shall continue to apply, particularly as regards tuberculosis.

(1) The competent Authority shall ensure that birds are

subject to trade only if generally

(a) they come from a holding in which avian influenza

has not been diagnosed in the 30 days preceeding the

dispatch;

(b) they come from a holding or an area not subject to

restrictions under measures to be applied to combat Newcastle

disease; and

(c) they have been quarantined, if they have been

imported from a third country, in the holding to which they

were taken after they entered the territory of the Community.

(2) Further to the provisions of sub-rule (1) hereof,

psittacidae shall

(a) not come from a holding nor have been in contact

with animals from a holding on which psittacosis (Chlamydia

psittaci) has been diagnosed. The period of prohibition since

the last recorded case and the period of treatment under

veterinary supervision in terms of these rules shall be of at

least two months;

(b) be identified in accordance with the methods for

identifying psittacidae, and in particular sick psittacidae, which

shall be established under the procedure concerning veterinary

checks in terms of these rules; and

(c) be accompanied by a commercial document signed

by the official veterinarian or by the veterinarian responsible

for the holding or business of origin and empowered for this

purpose by the competent authority.

The competent Authority shall ensure that bees (Apis

melifera) may be subject to trade only if

(a) they come from an area which is not the subject of

a prohibition order associated with an occurrence of American

foulbrood. The period of prohibition must continue for at least

30 days following the last recorded case and the date on which

all hives within a radius of three kilometres have been checked

by the competent authority and all infected hives burned or

treated and inspected to the satisfaction of the said competent

authority. In accordance with the procedure for veterinary

checks in terms of these rules, the requirements applied to bees

(Apis melifera) or equivalent requirements may be applied to

bumble bees; and

(b) they are accompanied by a health certificate

corresponding to the specimen in Schedule E to these rules,

the declaration in which shall be completed by the competent

authority to certify that the requirements laid down in paragraph

(a) are met.

The competent Authority shall ensure that lagomorphs

are subject to trade only if

(a) they do not come from or have been in contact

with animals from a holding in which rabies is present or is

suspected of having been present within the last month; and

(b) they come from a holding in which no animal shows

clinical signs of myxomatosis.

(1) The competent Authority shall ensure that there is a

prohibition on trade in ferrets, mink and foxes which come from or

have been in contact with animals from a holding in which rabies is

present or is suspected of having been present within the previous

six months, unless a systematic vaccination programme is applied.

(2) To be subject to trade, dogs and cats shall satisfy the

following requirements

(a) animals more than three months old shall

(i) show no sign of disease, and particularly of

contagious diseases of the species, on the day they are

dispatched from the holding;

(ii) be tattooed or have a micro-chip identification

system implanted in terms of specified rules which shall

be established by means of the procedure regarding

veterinary checks;

(iii) have after the age of three months, been

vaccinated against rabies with an annual booster injection

or, at intervals authorised by the competent Authority

for that vaccine, by injection of an inactivated vaccine

of at least one international antigenic unit (World Health

Organisation standard) measured in accordance with the

activity test by the method described by the European

Pharmacopoeia and recognised by means of the procedure

regarding veterinary checks in terms of these rules. The

vaccination shall be certified by an official veterinarian

or by the veterinarian responsible for the holding of

origin and empowered for this purpose by the competent

Authority. The vaccination certificate must bear the name

of the vaccine and its batch number (self-adhesive label

if possible);

(iv) in the case of dogs, have been vaccinated

against canine distemper; and

(v) be accompanied by an individual passport

allowing the animal to be clearly identified and showing

the dates of vaccination and, or a certificate corresponding

to the declaration laid down in the specimen shown in

Schedule E to these rules, and which declaration shall be

completed by an official veterinarian or by the veterinarian

responsible for the holding of origin and empowered for

this purpose by the competent authority; and

(b) animals less than three months old shall

(i) satisfy the requirements of the first and fifth

items of paragraph (a);

(ii) not come from a holding which is the subject

of restrictions on the movement of animals on animal

health grounds; and

(iii) have been born on the holding of origin and

have been maintained in captivity since birth.

(3) The competent Authority shall ensure that the costs

of applying the serological test are borne by the importers.

(1) The competent Authority shall ensure that only

semen, ova and embryos meeting the conditions laid down in sub-

rules (2) and (3) hereof are subject to trade.

(2) Semen of the ovine, caprine and equine species

shall, without prejudice to any criteria to be complied with for the

entry of equids in stud books for certain specific breeds

(a) have been collected and processed with a view to

artificial insemination in a centre approved from the health

point of view in accordance with Schedule D (I) to these

rules, or, in the case of ovine and caprine animals by way of

derogation from the above mentioned holding centre;

(b) have been collected from animals meeting the

conditions laid down in Schedule D (II) - (admission and

routine checks on animals);

(c) have been collected, processed and preserved in

accordance with Schedule D (III); and

(d) have been accompanied during transport to

another Member State by a health certificate corresponding

to a specimen which shall be determined according to the

procederure concerning veterinary checks established in rule

3(2) of these rules.

(3) Ova and embryos of the ovine or caprine and equine

species and of swine shall

(a) have been removed by a collection team approved

by the competent authority in Malta and processed in an

appropriate laboratory from donor females meeting the

conditions laid down in Schedule D (IV) to these rules;

(b) have been treated and stored in accordance with

Schedule D (III) to these rules; and

(c) be accompanied during transport to another Member

State by a health certificate in accordance with the procedure

concerning veterinary checks established in rule 3(2) of these

rules. Semen used for the insemination of donor females must

comply with the provisions of sub-rule (2) hereof in the case of

sheep, goats and equids and with the provisions for swine.

(1) The rules on checks shall continue to apply, in

particular as regards the organisation of and follow-up to the

checks to be carried out, to the animals, semen, ova and embryos

being referred to in these rules, which are accompanied by a health

certificate. Other animals shall come from holdings subject to the

principles regarding checks at the point of origin and at those carried

out by the Member State of destination.

(2) The communication of the place of destination shall,

with respect to animals, semen, ova or embryos accompanied by a

health certificate in accordance with these rules, take place using the

Animo system.

(3) For the purposes of trade, the general rules

applicable to veterinary checks shall extend to dealers who keep,

on a permanent or temporary basis, animals referred to in rules 7, 9

and 10 hereof.

(4) Without prejudice to the specific provisions of

these rules, the competent Authority shall, where it is suspected that

these rules have not been complied with or there is doubt as to the

health of the animals or the quality of the semen, ova and embryos

referred to in sub-rule (1) hereof, carry out any checks as it deems

appropriate.

(5) The competent Authority shall take the appropriate

administrative or penal measures to penalise any infringement of

these rules, in particular where it is found that the certificates or

documents drawn up do not correspond to the actual state of the

animals referred to in sub-rule (1) hereof, that the identification of the

animals or the marking of the semen, ova and embryos in question

does not comply with these rules or that the animals or products in

question have not undergone the necessary checks provided for in

these rules.

(1) Trade in animals of species susceptible to the

diseases listed in Schedule A or to the diseases listed in Schedule

B, where the Member State of destination applies the guarantee

provided by the control or monitoring program drawn up by the

competent Authority, and trade in semen, ova or embryos of such

animals consigned to and from bodies, institutes or centres approved

in accordance with Schedule C to these rules, shall be subject to

production of a transport document corresponding to the specimen in

Schedule E to these rules. Such document, which shall be completed

by the veterinarian responsible for the body, institute or centre

of origin, must specify that the animals, semen, ova or embryos

come from a body, institute or centre approved in accordance with

Schedule C and must accompany them during transport.

(2) To be approved, bodies, institutes or centres shall,

as regards notifiable diseases, submit to the competent Authority

all relevant supporting documents relating to the requirements

contained in Schedule C to these rules.

(3) After receiving the file relating to the request for

approval or for renewal of approval, the competent Authority shall

examine it in the light of the information it contains and, where

appropriate, of the results of the tests conducted on the spot.

(4) The competent Authority shall withdraw approval

in accordance with point 3 of Schedule C to these rules.

The conditions applicable to imports into the Community Conditions applicable

of animals, semen, ova and embryos covered by these rules shall to

be at least equivalent to those laid down in the aforementioned animals.

provisions.

The competent Authority shall have the power to make Powers of the

the entry into the Maltese territory of animals, including cage birds, Authority.

semen, ova and embryos referred to in these rules, which have passed

through the territory of a third country, subject to the production of

a health certificate certifying compliance with the requirements of

these rules.

(1) Any person who fails to abide by these rules shall Offences and

be guilty of an offence in terms of the Act and the provisions and penalties.

measures of rule 3 (4) and (5) shall apply to it.

(2) Any right given to the competent Authority under

these rules to apply all such necessary measures prescribed in sub-

rules (4) and (5) of rule 3 hereof, shall be given to the Authority

without prejudice to other criminal procedures which may be taken

under the Act or any other law when a person commits an offence by

failing to abide by these rules.

B

Schedule A

Regulations 2(2) and 13(1)

NOTIFIABLE DISEASES IN THE CONTEXT OF THESE RULES (a)

Diseases

Species concerned

Newcastle disease, avian influenza

Birds

Psittacosis

Psittacidae

American foulbrood

Bees

Foot-and-mouth disease

Ruminants

Brucellosis (Brucella ssp.)

Tuberculosis

Classical swine fever

Suidae

African swine fever

Foot-and-mouth disease

Rabies (b)

All susceptible species

(a)

Without prejudice to the notifiable diseases provided for in Annex I to Directive

82/894/EEC.

(b)

In accordance with Article 2 of Directive 89/455/EEC.

B

Schedule B

Regulations 2(2), 4(b) and 13(1)

LIST OF DISEASES FOR WHICH NATIONAL PROGRAMMES MAY BE

RECOGNIZED UNDER THESE RULES

Mink

Viral enteritis

Aleutian disease

Bees

European foulbrood

varroasis and acariasis

Apes and felids

Tuberculosis

Ruminants

Tuberculosis

Lagomorphs

Myxomatosis

Viral haemorrhagic disease

Tularaemia

B

Schedule C

Regulation 13 (1) and (4)

CONDITIONS GOVERNING APPROVAL OF BODIES, INSTITUTES OR

CENTRES

1. In order to be granted official approval under rule 13 (2) of these rules, a body,

institute or centre as defined in rule 2 (2) hereof must

(a) be clearly demarcated and separated from its surroundings;

(b) be situated at a reasonable distance from agricultural establishments whose

health status might be jeopardized by the presence of the approved body, institute or

centre;

(c) be under the control of a veterinarian (¹) who monitors the animals, which it

must be possible to catch, confine and cage at any time;

(d) have adequate quarantine facilities;

(e) have one or more appropriate premises to practise post-mortem examination;

(f) be free of the diseases listed in Schedule A and, as regards the diseases covered

in the country concerned by a monitoring programme, the diseases listed in

Schedule B;

(g) keep up-to-date records indicating

- the number of animals of each species present in the establishment, with

information as to their ages,

- the number of animals arriving in the establishment or leaving it, together with

information on their transport and the animals' health,

- observations made during the quarantine period,

- the results of regular examinations of excreta,

- the results of blood tests or any other diagnostic procedures,

(¹) Responsible for day-to-day compliance with the animal health requirements of these rules.

B

- cases of disease and, where appropriate, the treatment administered,

- the results of the dissection of any animals that die in the establishment, including

still-born animals;

(h) have facilities for appropriate disposal of the bodies of animals which die of a

disease;

(i) be monitored by an official veterinarian who must carry out at least two health

checks per year.

Health checks must include at least

- one inspection of all the animals in the establishment,

- representative samples taken from all the species susceptible to the diseases

referred to in Schedules A and B (²) or detection of these diseases by other methods.

These samples must be analysed by an approved laboratory to check whether they

contain agents of the diseases for each species in Schedule A. Samples may be

taken throughout the year.

The results of the laboratory tests on the samples taken during the health checks

must reveal no evidence of the pathogens in question;

- examination of the records which must be kept.

2. Approval shall be retained where the following requirements are met

(a) the animals brought into the establishment must come from another approved

centre, institute or body;

(b) if animals covered by Directive 64/432/EEC are held in an approved centre,

institute or body, they may leave the establishment only under official control;

(c) health checks in the approved centre, institute or body must be carried out twice

a year, in accordance with point 1 (h) of this Schedule.

(d) the results of the laboratory tests on the samples must reveal no trace of agents

of the diseases referred to in Schedules A and B (²);

(²) Inasmuch as one of these diseases is notifiable in the Malta.

B

(e) any suspect deaths or the presence of any other symptom suggesting that

animals have contracted one or more of the diseases referred to in Schedules A and

B (¹) must be notified without delay to the competent authority.

3. Approval may be suspended, restored or withdrawn in the following

circumstances

(a) where notification is given within the meaning of 2 (d) of this Schedule, the

competent authority shall temporarily suspend approval of the approved centre,

body or institute;

(b) a sample taken from a suspect animal is forwarded to the approved laboratory to

test for the presence of the pathogens in question. The test results shall immediately

be forwarded to the competent authority;

(c) where the official department has been informed of suspicions as to the presence

of one of the diseases referred to in Schedules A and B (¹), it shall reacts, as regards

the laboratory tests, the epizootiological examination, the measures to be taken

against the disease and the withdrawal of approval, as if the disease had been

notified, in accordance with these rules’ governing measures in this field to be taken

against the diseases and trade in animals;

(d) where the test results show no signs of the pathogens concerned, the official

department shall reinstate approval;

(e) the body, institute or centre shall again be approved only where, after

eradication of the sources of infection, the conditions laid down in point 1 of this

Schedule, with the exception of point 1 (f), are again fulfilled;

(f) the competent authority shall inform the Commission of the suspension,

restoration or withdrawal of approval.

(¹) Inasmuch as one of these diseases is notifiable in the Malta.

B

Schedule D

Regulation 11 (2) (a)(b)(c) and (3) (a) (b)

CHAPTER I

I. Conditions governing the approval of semen collection centres

Semen collection centres must

1. be placed under the supervision of a 'centre veterinarian';

2. have different and physically separate premises for

- accommodating and isolating animals,

- collecting semen,

- cleaning and disinfecting equipment,

- processing semen,

- storing semen;

3. be built or kept separate in such a way as to prevent any contact with animals

outside the centre;

4. have premises such as described at 2 which are easily cleaned and disinfected,

II. Conditions for the supervision of semen collection centres

Semen collection centres must

1. be monitored to ensure that only animals whose semen is to be collected are kept

there. However, other domestic animals may stay in these centres provided they

meet the general conditions set out below.

2. be monitored to ensure that a register is kept showing

- the identity of the animals present in the centre,

- any movements of animas (entering and leaving),

- the health checks made,

B

- the health history,

- the destination of the semen,

- the storage of the semen;

3. be inspected at least twice a year by an official veterinarian to ensure that the

approval and supervision conditions are met;

4. employ competent staff who have received adequate training on disinfection and

hygiene techniques to allow the spread of disease to be avoided;

5. be monitored to ensure that

- the collection, processing and storage of semen is carried out only in premises set

aside for these purposes,

- all utensils coming into contact with the semen or the donor animal during

collection or processing are properly disinfected or sterilized before each use,

- any recipient for the storage or transport of semen is disinfected or sterilized

before use;

6. be sure to use

- products of animal origin used in the processing of the semen (additive or diluent)

which present no health risks or which have undergone prior processing to preclude

such risks,

- a cryogenic agent which has not previously been used for other products of animal

origin;

7. ensure that each quantity of semen is adequately identified in such a way that the

date of collection, the breed and the identity of the donor animal may be established

as well as the name of the approved centre which made the collection.

CHAPTER II

Conditions applicable in collection centres

Requirements as regards the admission of donor males

B

A. STALLIONS

Only stallions which, to the satisfaction of the official veterinarian, meet the

following requirements may be used for the collection of semen

1. they must be in good health at the time of collection;

2. they must satisfy the requirements of Directive 90/426/EEC and come from

holdings which also satisfy those requirements;

3. during the 60 days before the first collection they must have undergone with

negative results the following tests

(a) to detect equine infectious anaemia, an agar-gel immunodiffusion test, known as

the 'Coggins test'

(b) to detect viral artheritis, a sero-neutralization test (dilution < ¹/4) supplemented,

in the event of a positive result, by virological examination of total semen with a

negative result;

(c) to detect contagious equine metritis by isolating the Taylorella equigenitalis

germ, at least a test of samples taken from the urethra and the pre-ejaculatory fluid.

The result of these tests must be certified by a laboratory recognized by the

competent authority.

During the period mentioned in the first paragraph of 3 above, and during the

collection period, stallions may not be allowed do serve naturally.

B. SHEEP AND GOATS

1. Only sheep and goats from centres or holdings which, to the satisfaction of the

official veterinarian, meet the following requirements may be used for the

collection of semen

(a) they are in good health on the day the semen is collected;

(b) they meet the requirements laid down in Articles 4, 5 and 6 of Directive

91/68/EEC on intra-Community trade.

B

In addition, donor animals must undergo, during the thirty days before the

collection, with negative results

- a test to detect brucellosis (B. melitensis) in accordance with Annex C to Directive

91/68/EEC,

- a test for contagious epididymitis (B. ovis) in accordance with Annex D to

Directive 91/68/EEC,

- a test for the Border disease virus;

(c) they have undergone the relevant tests or checks designed to guarantee

compliance with the requirements set out in (a) and (b) above.

2. The tests referred to in 1. must be carried out by a laboratory approved in Malta.

C. If any of the tests referred to in A or B proves positive, the animal must be

isolated and the semen collected from it since the last negative test may not be

placed on the market. The same applies to semen collected from the other animals

at the holding or collection centre since the date on which the positive test was

carried out. Trade may not resume until the health status of the centre has been re-

established.

CHAPTER III

Requirements applicable to semen, ova and embryos

Semen, ova and embryos must have been collected, processed, washed and

preserved with a biological product free of living micro-organisms in accordance

with the following principles

(a) the washing of ova and embryos must be carried out in accordance with rule 11

(3) of these rules. Their pellucid zone must remain intact before and after washing.

Only ova and embryos from one and the same donor may be washed at any one

time. After washing, the pellucid zone of each ovum or embryo must be examined

over its entire surface area under a magnification of at least 50 and be certified as

being intact and free of any foreign body adhering to it;

B

(b) the medium and solutions used for the collection, freezing and conservation of

ova and embryos must be sterilized in accordance with approved methods as laid

down in rule 11 (3) and handled in such a way that they remain sterile. Antibiotics

must be added to the collection, washing and conservation mediums;

(c) all materials used for the collection, handling, washing, freezing and

conservation of ova or embryos must be sterilized before use;

(d) they must have been subjected, in accordance with rule 11 (2), to additional

tests, in particular of the collection or washing liquids, so as to establish that no

pathogens are present;

(e) they must be kept in sterile recipients

- containing only products from one male or female donor,

- sealed at the time of freezing in alcohol or fresh liquid nitrogen, and labelled,

and be placed in sterilized liquid nitrogen containers which present no risk of

contamination to the products;

(f) they must be stored in approved conditions for a minimum period of 30 days

prior to dispatch;

(g) they must be transported in flasks which have been cleaned, disinfected or

sterilized before use.

CHAPTER IV

Donor females

Females may be used for the collection of embryos or ova only if they meet, to the

satisfaction of the official veterinarian, the requirements of the relevant Directives

on intra-Community trade in live animals for breeding and production for the breed

concerned, viz. Directive 64/432/EEC for swine, Directive 90/426/EEC for equids

and Directive 91/68/EEC for ovine and caprine animals and come from herds which

also meet the said requirements.

B

Schedule E

Regulations 6 (1) (f) and 10 (2) (a) (v)

CERTIFICATE

EUROPEAN COMMUNITY

HEALTH CERTIFICATE

1. Name and address of the consignor

ORIGINAL ( a )

No

2. MEMBER STATE OF ORIGIN

3. Name and address of the consignee

4. COMPETENT AUTHORITY

5. Address

-

of holding of origin or of an

officially approved body, institute

or centre of origin ( b )

-

of holding or business of

destination or of an officially

approved body, institute or centre

of origin ( b )

6. Place of loading

7. Means of transport

B

8. Species

9. Number of animals/hives/queens (with attendants)) ( b )

10. Batch Identification

11. ATTESTATION ( c )

Made in ……………… on the ………………

Signature

Name in capital letters

Title and position

( a ) A separate certificate shall be provided for every delivery and the original shall be sent together with

the delivery to the final destination, which validity period is of 10 days.

( ) Delete as applicable.

b

( c ) Complete according to Articles 5 to 11 of Directive 92/65/EEC within 24 hours prior to the loading of

animals.

B

Declaration to be filled as per rule 6 (1) (f)

I, the undersigned (official veterinarian) certify that the ruminant/suida 1 other than

that covered by Directive 64/432/EEC

(a) belongs to the . . . . . . species;

(b) at the time of examination, does not show any clinical sign of any disease to

which it is susceptible;

(c) comes from an officially tuberculosis-free/officially brucellosis-free or

brucellosis-free herd/a holding not subject to swine-fever restrictions (a) or from a

holding where it was subjected with negative results to the tests laid down in rule 6

(f) of these rules.

Delete as appropriate.

Declaration to be filled as per rule 10 (2) (a) (v)

I, the undersigned . . . . . . . . . . certify that the cats/dogs 1 covered by this certificate

satisfy the requirements of rule 10 (2) (a) (v) of these rules and come from a

holding in which no case of rabies has been recorded in the last six months.

Delete as appropriate.

€2.61