ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT (sl_437.98) | MT

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Preamble — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

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SUBSIDIARY LEGISLATION 437.98

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 *

12th June, 2015

LEGAL NOTICE 192 of 2015.

CHAPTER I

General provisions

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 1 Citation and scope. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

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

Requirements governing Trade in and Imports into the Community of

Animals, Semen, Ova and Embryos not subject to Animal Health

Requirements laid down in Specific Community Acts Rules.

(2) These rules lay down the animal health requirements

governing trade in and imports into the Community of animals,

semen, ova and embryos not subject to the animal health requirements

laid down in the specific Community acts referred to in Schedule F

which shall apply without prejudice to the provisions adopted

pursuant to other national rules and community rules which may

apply in this regard. These rules shall apply without prejudice to the

provisions adopted pursuant to Commission Regulation (EEC) No

3626/82.

These rules shall not affect national rules applicable to pet

animals, although their retention may not jeopardize the abolition of

veterinary checks at the frontiers between Member States. These rules

shall be read together with Council Regulation (EU) No. 576/2013 on

the non commercial movement of pet animals and repealing

Regulation (EC) No.998/2003 and Council Regulation (EU) No. 577/

2013 on the model identification documents for the non-commercial

movement of dogs, cats and ferrets, the establishment of lists of

territories and third countries and the format, layout and language

requirements of the declarations attesting compliance with certain

conditions provided for in Regulation (EU) No 576/2013 of the

European Parliament and of the Council.

(3) The scope of these rules is to transpose Directive 92/65/

EEC with all amendments, including Directive 2013/31/EU, thereto

and related Decisions.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Schedule A — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

Notifiable diseases in the context of Directive 92/65/EEC

Disease

Order/family/species primarily concerned

African horse sickness

Equidae

African swine fever

Suidae and Tayassuidae

Avian influenza

Aves

American foulbrood

Apis

Anthrax

Bovidae, Camelidae, Cervidae, Elephantidae, Equidae

and Hippopotamidae

Bluetongue

Antilocapridae, Bovidae, Cervidae, Giraffidae, and

Rhinocerotidae

Brucella abortus

Antilocapri dae, Bovidae, Camelidae, Cervidae,

Giraffidae, Hippopotamidae and Tragulidae

Brucella melitensis

Antilocapridae, B ovidae, Camelidae, Cervidae,

Giraffidae, Hippopotamidae and Tragulidae

Brucella ovis

Camelidae, Tragulidae, Cervidae, Giraffidae, Bovidae

and Antilocapridae

Brucella suis

Cervidae, Leporidae, Ovi bos moschatus, Suidae and

Tayassuidae

Classical swine fever

Suidae and Tayassuidae

Contagious bovine

Bovines (including zebu, buffalo, bison and yak)

pleuropneumonia

Ebola

Non-human primates

Foot-and-mouth disease

Artiodactyla and Asian elephants

Infectious haematopoeitic Salmonidae

necrosis

Lumpy skin disease

Bovidae and Giraffidae

Monkey pox

Rodentia and non-human primates

Mycobacterium bovis

Mammalia, in particular Antilocapridae, Bovidae,

Camelidae, Cervidae, Giraffidae, and Tragulidae

Newcastle disease

Aves

Peste des petits ruminants

Bovidae and Suidae

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Porcine enterovirus

Suidae

encephalomyelitis

Psitacosis

Psittaciformes

Rabies

Carnivora and Chiroptera

Rift valley fever

Bovidae, Camelus species and Rhinocerotidae

Rinderpest

Artiodactyla

Small hive beetle

Apis and Bombus

(Aethina tumida)

Sheep and goat pox

Bovidae

Swine vesicular disease

Suidae and Tayassuidae

Tropilaelaps mite

Apis

(Tropilaelaps spp.)

Vesicular stomatitis

Artiodactyla and Equidae

TSE

Bovidae, Cervidae, Felidae and Mustelidae

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 2 Interpretation. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

Unless otherwise provided in these Rules, the following

definitions shall apply and the definitions, other than those of

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

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approved centres and bodies, contained in any other law or rule

governing trade shall mutatis mutandis apply, unless they are

inconsistent with these rules

"Act" means the Veterinary Services Act;

"animals" means specimens of animal species other than those

animals referred to in other Community law, in Directives 64/432/

EEC, 90/426/EEC, 90/539/EEC, 91/67/EEC, 91/68/EEC, 91/492/

EEC and 91/493/EEC, which mean -

(a) Ungulates

(i)

bovine animals including specimens of the species

Bubalis bubalis;

(ii)

swine (with the exception of feral pigs);

(iii)

equidae including all wild or domesticated animals

of the equine (including zebras) or asinine species

or the offspring of crossings of those species;

(iv)

ovine or caprine animals;

(b) poultry including

(i)

fowl, turkeys, guinea fowl, ducks, geese, quails,

pigeons, pheasants, partridges and ratites (Ratitae)

reared or kept in captivity for breeding, the

production of meat or eggs for consumption, or

for re-stocking supplies of game;

(ii)

hatching eggs meaning eggs for incubation, laid

by poultry; and

(iii)

‘day-old chicks’ of all poultry which are less than

72 hours old, not yet fed; however, muscovy ducks

(Cairina moschata) or their crosses may be fed;

(c) imported aquaculture animals and products thereof

including consignments in transit;

(d) ‘bivalve molluscs’ which

means

filter-feeding

lamellibranch molluscs;

(e) animals as defined in Regulation (EU) No 576/2013 of

the European Parliament and of the Council. The term

‘animals’, shall not apply to

(a) ornamental aquatic animals reared in non-

commercial aquaria;

(b) wild aquatic animals harvested or caught for

direct entry into the food chain;

(c) aquatic animals caught for the purpose of

production of fishmeal, fish feed, fish oil and

similar products.

The term ‘animals’ applies to all animals listed in Schedule H, Parts

A and B, as well as all other animals not excluded by the previous

paragraphs;

"approved body, institute or centre" means any permanent,

geographically limited establishment, approved in accordance with

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rule 13, 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

-

display of the animals and education of the public

holding a zoo licence in terms of the Keeping of Wild

Animals in Zoos Regulations;

-

conservation of the species;

-

basic or applied scientific research or breeding of

animals for the purposes of such research holding an

authorisation or licence in terms of the Protection of

Animals for Scientific Purposes Regulations;

"aquaculture products" means all fishery products born and raised

in controlled conditions until placed on the market as a foodstuff

However seawater or freshwater fish or crustaceans caught in their

natural environment when juvenile and kept until they reach the

desired commercial size for human consumption are also considered

to be aquaculture products. Fish and crustaceans of commercial size

caught in their natural environment and kept alive to be sold at a later

date are not considered to be aquaculture products if they are merely

kept alive without any attempt being made to increase their size or

weight;

"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;

"commercial document" means a document that may or may not

have tax value, which contains specific reference to the consignment

together with means of identification of the consignment, which may

accompany the consignment and it shall be used by the competent

authorities together or not with the veterinary documentation, in order

to carry out either a documentary or an identity check of the

consignment, or both;

"the Community" means the Community of the European Union;

"competent authority" means the Veterinary Services in Malta, as

referred to in the Act;

"final consumer" means any natural or legal person purchasing

animals and animal products subject to trade for his own use and not

for resale or transfer purposes;

"fishery products" means all seawater or freshwater animals or

parts thereof, including their roes, excluding aquatic mammals, frogs

and aquatic animals covered by Community acts, other than Directive

92/65/EEC;

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"health certificate" means a certificate issued by the competent

authority of the country of origin or despatch 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 of the European

Union;

" m o n i to r i ng p r og r a m m e " m e a n s a c on t r ol o r m o n i to r i ng

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;

"notifiable diseases" means the diseases listed in Schedule A;

"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 and the same meaning given to trade in these rules;

"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;

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"registered dealer" means an importer, exporter, person responsible

for the load, brokers, middlemen and any legal person or entity

involved in trade;

"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" shall have the meaning as defined by Article 9(2) of the

Treaty as well as any transfer, movement or exchange between

holdings or sites and, or all classes of natural and legal persons

whether profitable or not;

"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, m onitoring,

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.

CHAPTER II

Provisions applicable to trade

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Schedule B — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

List of diseases for which national programmes may be recognized under Directive

92/65/EEC

Mink

Viral enteritis

Aleutian disease

Bees

European foulbrood

varroasis and acariasis

Apes and felids

Tuberculosis

Ruminants

Tuberculosis

Lagomorphs

Myxomatosis

Viral haemorrhagic disease

Tularaemia

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Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 3 Prohibitions of, or restrictions on, trade for animal health reasons. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

Trade, as referred to in rule 1(2), is not prohibited or

restricted for animal health reasons other than those arising from the

application of these rules or from other local and Community

legislation, and in particular any safeguard measures taken.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Schedule C — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

Conditions governing approval of bodies, institutes or centres

1. In order to be granted official approval under Article 13(2) of Directive 92/65/

EEC, a body, institute or centre as defined in Article 2(1)(c) must

(a) be clearly demarcated and separated from its surroundings or the animals

confined and located so as not to pose a health risk to agricultural holdings

whose health status might be jeopardised;

(b) have adequate means for catching, confining and isolating animals and,

have available adequate quarantine facilities and approved procedures for

animals coming from non-approved sources;

(c) be free of the diseases listed in Annex A and the diseases listed in Annex B

where the country concerned has a programme pursuant to Article 14. In

order that a body, institute or centre is declared free from these diseases,

the competent authority shall assess the records on the animal health

status kept for at least the previous three years and the results of the

clinical and laboratory tests carried out on the animals in the body, institute

or centre. However, by way of derogation from this requirement new

establishments shall be approved if the animals forming the collection are

derived from approved establishments;

(d) keep up to date records indicating

(i)

the number and identity (age, sex, species and individual

identification where practical) of the animals of each species present

in the establishment;

(ii)

the number and identity (age, sex, species and individual

identification where practical) of animals arriving in the

establishment or leaving it, together with information on their origin

or destination, the transport from or to the establishment and the

animals health status;

(iii)

the results of blood tests or any other diagnostic procedures;

(iv)

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

(v)

the results of the post-mortem examinations on animals that have

died in the establishment, including still-born animals;

(vi)

observations made during any isolation or quarantine period;

(e) either have an arrangement with a competent laboratory to perform post-

mortem examinations, or have one or more appropriate premises where

these examinations may be performed by a competent person under the

authority of the approved veterinarian;

(f)

either have suitable arrangements or on-site facilities for the appropriate

disposal of the bodies of animals which die of a disease or are euthanised;

(g) secure, by contract or legal instrument, the services of a veterinarian

approved by and under the control of the competent authority, who

(i)

shall comply mutatis mutandis with the requirements referred to in

Article 14(3)(B) of Directive 64/432/EEC,

(ii)

shall ensure that appropriate disease surveillance and control

measures in relation to the disease situation of the country

concerned are approved by the competent authority and applied in

the body, institute or centre. Such measures shall include

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-

an annual disease surveillance plan including appropriate

zoonoses control of the animals,

-

clinical, laboratory and post-mortem testing of animals

suspected to be affected by transmissible diseases,

-

vaccination of susceptible animals against infectious diseases

as appropriate, only in conformity with Community legislation;

(iii)

shall ensure that any suspect deaths or the presence of any other

symptom suggesting that animals have contracted one or more of the

diseases referred to in Annexes A and B is notified without delay to

the competent authority, if that particular disease is notifiable in the

Member State concerned;

(iv)

shall ensure that incoming animals have been isolated as

necessary, and in accordance with the requirements of Directive

92/65/EEC and the instructions, if any, given by the competent

authority;

(v)

shall be responsible for the day to day compliance with the animal

health requirements of Directive 92/65/EEC and of Community

legislation on welfare of animals during transport and disposal of

animal waste;

(h) if it keeps animals intended for laboratories carrying out experiments, in

conformity with the provisions of Article 5 of Directive 86/609/EEC.

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

(a) the premises are under the control of an official veterinarian from the

competent authority, who

(i)

shall visit the premises of the body, institute or centre at least once

per year;

(ii)

shall audit the activity of the approved veterinarian and the

implementation of the annual disease surveillance plan;

(iii)

shall ensure that the provisions of Directive 92/65/EEC are met;

(b) only animals coming from another approved body, institute or centre, are

introduced into the establishment, in accordance with the provisions of

Directive 92/65/EEC;

(c) the official veterinarian verifies that

other provisions of Directive 92/65/EEC are fulfilled,

the results of the clinical, post-mortem and laboratory tests on the

animals have revealed no occurrence of the diseases referred to in

Annexes A and B;

(d) the body, institute or centre keeps the records referred to in point 1(d)

after approval, for a period of at least ten years.

3. By way of derogation from Article 5(1) of Directive 92/65/EEC and point 2(b) of

this Annex, animals including apes (simiae and prosimiae) having an origin other than

an approved body, institute or centre may be introduced in an approved body, institute or

centre, provided that these animals undergo a quarantine under official control and in

accordance with the instructions given by the competent authority before being added to

For apes (simiae and prosimiae) the quarantine requirements laid down in the OIE

International Health Code (Chapter 2.10.1 and Appendix 3.5.1) shall be respected.

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For other animals undergoing quarantine in accordance with point 2(b) of this

Annex, the quarantine period must be at least 30 days with respect to the diseases

listed in Annex A.

4. Animals held in an approved body, institute or centre, shall only leave this

establishment if destined to another approved body, institute or centre, in that Member

State or another Member State; however, if not destined to an approved body, institute or

centre, shall only leave in accordance with the requirements of the competent authority

to ensure no risk of possible spread of disease.

5. Where a Member State benefits from additional guarantees under Community

legislation it may request appropriate additional requirements and certification for the

susceptible species to be added to the approved body, institute or centre.

6. The procedures for partly or completely suspending, withdrawing or restoring

approval are the following

(a) where the competent authority finds that the requirements of point 2 have

not been fulfilled or there has been a change of usage which is no longer

covered by Article 2 of Directive 92/65/EEC the approval shall be

suspended or withdrawn;

(b) where notification is given of the suspicion of one of the diseases listed in

Annex A or B, the competent authority shall suspend approval of the body,

institute or centre, until the suspicion has been officially ruled out.

Depending on the disease involved and the risk of disease transmission, the

suspension may relate to the establishment as a whole or only to certain

categories of animals susceptible to the disease in question. The competent

authority shall ensure that the measures necessary to confirm or rule out

the suspicion and to avoid any spread of disease are taken, in accordance

with Community legislation governing measures to be taken against the

disease in question and on trade in animals;

(c) where the suspected disease is confirmed, the body, institute or centre shall

again be approved only when, after eradication of the disease and source of

infection in the premises, including suitable cleaning and disinfection, the

conditions laid down in point 1 of this Annex, with the exception of point

1(c), are again fulfilled;

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

withdrawal or restoration of approval of a body, institute or centre.

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Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 4 Trading or placing on the market of animals. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

(1) Animals cannot be traded or placed on the market

unless they are identified and registered in accordance with

Community rules and Maltese legislation. All animals and products

of animal origin originating therefrom intended for trade or placed on

the market shall have to be compliant with the national and

Community health and zootechnical requirements at all stages of

production and trade.

(2) The competent authority shall implement the following

inspection measures on arrival of animals also in transit in the

territory of Malta

(a) the competent authority may, at entry points, control

posts and, or at the places of destination of animals and

products thereof, establish by means of non-

discriminatory veterinary spot checks that animals and

products being traded are compliant with all the relevant

national and Community health and zootechnical

requirements; it may take samples at the same time.

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Furthermore, checks may also be carried out during the

transport of animals and products thereof in its territory

where the competent authority has information leading it

to suspect an infringement of the rules;

(b) furthermore, where the animals originating in another

State are intended -

(i)

for an approved market or assembly centre as

defined by Community rules, the operator thereof

shall be responsible for the admission of animals

not meeting the requirements of these rules. The

competent authority must check, by means of non-

discriminatory inspections of the certificates or

documents accompanying the animals, that the

animals meet the said requirements;

(ii)

for a slaughterhouse placed under the supervision

of an official veterinarian, the latter must ensure,

in particular on the basis of the certificate that only

animals that meet the requirements of this rule are

slaughtered. The operator of the slaughterhouse

shall be responsible for slaughtering animals

which do not meet the requirements of this rule;

(iii)

for a registered dealer who divides up the

consignments or for any establishment not subject

to permanent supervision, such dealer or

establishment shall be regarded by the competent

authority as the consignee of the animals and shall

be responsible for the movement and, or trade of

animals which do not meet the requirements of

this rule;

(iv)

for holdings, centres or organizations including,

where the consignment is partly unloaded during

transport, each animal or group of animals must be

accompanied by the original health certificate or

accompanying document until it reaches the

consignee mentioned therein.

(3)

The consignees referred to in sub-rule (2)(b)(iii) and (iv)

(a) be registered in an official register before starting to

trade;

(b) keep a record of all consignments and deliveries. before

any consignment is divided up or subsequently marketed,

and check that the identification marks, certificates or

documents are present;

(c) notify the competent authority of any irregularity or

anomaly and, in the latter case, isolate the animals in

question until the competent authority has taken a

decision regarding them;

(d) keep records of the subsequent destination of the animals

and products of the divided consignments.

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(4) The records referred to in sub-rule (3) shall be preserved for

a period of three years and the consignee shall make them available

on request by the competent authority. The competent authority shall

carry out random checks to verify compliance with these rules.

(5) All the consignees

appearing

on

the

certificates

or

accompanying document -

(a) shall, at the request of the competent authority and to

the extent necessary to carry out the checks referred to in

the this rule, report in advance the arrival of animals and

products thereof from another Member State and, in

particular, the nature of the consignment and the

anticipated arrival date. This limit is established as not

less than forty-eight hours in accordance with the

provisions of the Trading Regulations;

(b) shall keep, for a period of six months, the copies of the

original health certificates or accompanying documents

for presentation to the competent authority, on request, of

the animals or products thereof.

(6) Animals referred to in rules 5 to 10 may, without prejudice to

rule 13 and to the particular provisions to be adopted in

implementation of rule 24, be the subject of trade only if they satisfy

the conditions laid down in rules 5 to 10 and come from the holdings

or businesses, referred to in rule 12(1) and (3), which are registered

by the competent authority and which undertake to

(a) have the animals held examined regularly in accordance

with Community and Maltese legislation and animal

health programmes that are decided by the Director;

(b) notify the competent authority, aside from the outbreak

of notifiable diseases, of the outbreak of the diseases

referred to in Schedule B for which the competent

authority has drawn up a control or monitoring

programme;

(c) comply with the specific measures to control a disease

which is of particular importance to Malta and is covered

by a programme drawn up in accordance with rule 14 or a

decision under rule 15(2);

(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, only animals

accompanied by self-certification by the operator 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 accordance with Community and

Maltese legislation, or in line with national guidelines

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where such legislation is not available.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Schedule D — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

CHAPTER I

Conditions applicable to semen collection centres, semen storage centres, embryo

collection teams and embryo production teams

Conditions for the approval of semen collection and storage centres

1. In order to be given approval and the veterinary registration number referred to

in Article 11(4) each semen collection centre shall

1.1. be placed under the supervision of a centre veterinarian authorised by the

competent authority;

have at least

(a) lockable animal accommodation and if required for equidae an exercise

area which is physically separated from the collection facilities, the

processing and storage rooms;

(b) isolation facilities which have no direct communication with the normal

animal accommodation;

(c) semen collection facilities, that may be open air protected from adverse

weather effects, with slip-proof flooring which protects from dramatic

injury in case of fall, at and around the place of semen collection, without

prejudice to the requirements in point 1.4;

(d) a separate room for the cleansing and disinfection or sterilisation of

equipment;

(e) a semen processing room separated from the collection facilities and the

room for cleansing equipment referred to in point (d) which need not

necessarily be on the same site;

(f)

a semen storage room which need not necessarily be on the same site;

be so constructed or isolated that contact with outside livestock is prevented;

1.4. be so constructed that the entire semen collection centre except the office rooms

and, in the case of equidae the exercise area, can be readily cleansed and disinfected.

2. In order to be given approval each semen storage centre shall

(a) in the case the storage is not limited to semen of a single species collected

at semen collection centres approved in accordance with Directive 92/65/

EEC, or embryos are stored at the centre in compliance with Directive 92/

65/EEC, be given distinct veterinary registration numbers referred to in

Article 11(4) for each of the species the semen of which is stored at the

centre;

(b) be placed under the permanent supervision of a centre veterinarian

authorised by the competent authority;

(c) have a semen storage room furnished with the necessary installation to

store the semen and/or the embryos, which is so constructed that it protects

those products and the installation from adverse weather and environment

effects;

(d) be so constructed that contact with outside livestock or other animals is

prevented;

(e) be so constructed that the entire centre except the office rooms and, in

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the case of equidae the exercise area, can be readily cleansed and

disinfected;

(f)

be so constructed that unauthorised access of people is effectively

prevented.

Conditions for the supervision of semen collection and storage centres

1. Semen collection centres shall

be supervised to ensure that

(a) they contain only animals of the species whose semen is to be collected;

Other domestic animals may none the less also be admitted, provided that

they present no risk of infection to those species whose semen is to be

collected, and that they comply with the conditions laid down by the centre

veterinarian.

If in the case of equidae the semen collection centre shares a site with an

artificial insemination or service centre, then female equidae (mares) and

uncastrated male equidae (stallions) for teasing or natural service shall be

admitted provided that they meet the requirements of points 1.1, 1.2, 1.3

and 1.4 of Section I of Chapter II;

(b) the entry of unauthorised persons is prevented and that authorised visitors

are required to comply with the conditions laid down by the centre

veterinarian;

(c) only competent staff is employed who have received adequate training on

disinfection and hygiene techniques to prevent the spread of disease;

be monitored to ensure that

(a) records are kept which show

(i)

the species, breed, date of birth and identification of each animal

present in the centre;

(ii)

any movement of animals entering or leaving the centre;

(iii)

the health history and all diagnostic tests and the results thereof,

treatments and vaccinations carried out on animals kept;

(iv)

the date of collecting and processing semen;

(v)

the destination of semen;

(vi)

the storage of semen;

(b) none of the animals kept in the centre is used for natural breeding at least

30 days prior to the date of the first semen collection and during the

collection period;

(c) the collection, processing and storage of semen is carried out only in

premises set aside for these purposes;

(d) all instruments which come into contact with the semen or the donor

animal during collection and processing are properly disinfected or

sterilised prior to use, except for instruments which are new, disposable

and discarded after use (single-use instruments);

Where, in the case of equidae, the collection centre shares a site with an

artificial insemination centre or a service centre, there shall be a strict

separation between the semen and instruments and equipment for artificial

insemination or natural service and instruments and equipment coming into

contact with donor animals or other animals kept in the collection centre;

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(e) products of animal origin used in the processing of semen, including

diluents, additives or extenders, are obtained from sources which present

no animal health risk or are so treated prior to use that such risk is

prevented;

(f)

cryogenic agents used for the preservation or storage of semen have not

been previously used for other products of animal origin;

(g) storage containers and transport containers are either properly disinfected

or sterilised before the commencement of each filling operation, except for

containers which are new, disposable and discarded after use (single-use

containers);

(h) each individual dose of semen or each ejaculate of fresh semen intended

for further processing is clearly marked in such a way that the date of

collection of the semen, the species, the breed and identification of the

donor animal and the approval number of the semen collection centre can

be readily established;

1.3. be inspected by an official veterinarian during the breeding season at least

once every calendar year in the case of animals with seasonal breeding and twice every

calendar year in the case of a non-seasonal reproduction in order to consider and verify,

where necessary on the base of records, standard operating procedures and internal

audits, all matters relating to the conditions of approval, supervision and monitoring.

2. Semen storage centres shall

be supervised to ensure that

(a) the status of the donor animals whose semen is stored at the centre

complies with the requirements of Directive 92/65/EEC;

(b) the requirements laid down in points 1.1(b) and (c) are complied with;

(c) records are kept of all movement of semen entering and leaving the storage

centre;

be monitored that

(a) only semen collected in and coming from approved semen collection or

storage centres and transported in conditions offering every possible health

guarantee, having had no contact with semen not complying with Directive

92/65/EEC, is brought into an approved semen storage centre;

(b) storage of semen takes place only on the premises set aside for the purpose

and under strict conditions of hygiene;

(c) all instruments which come into contact with the semen are properly

disinfected or sterilised prior to use, except for single-use instruments;

(d) storage containers and transport containers are either properly disinfected

or sterilised before the commencement of each filling operation, except for

single-use containers;

(e) cryogenic agents used for preservation or storage of semen have not been

previously used for other products of animal origin;

(f)

each individual dose of semen is clearly marked in such a way that the

date of collection of the semen, the species, the breed and identification of

the donor animal, the approval number of the semen collection centre can

be readily established; each Member State shall communicate to the

Commission and other Member States the characteristics and form of the

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marking used in its territory;

2.3. by way of derogation from point 2.2(a), the storage of embryos in the approved

semen storage centre is authorised provided they meet the requirements of Directive

92/65/EEC and are stored in separate storage containers;

2.4. be inspected by an official veterinarian at least twice every calendar year in

order to consider and verify, where necessary based on records, standard operating

procedures and internal audits, all matters relating to the conditions of approval,

supervision and monitoring.

III. Conditions for the approval and the supervision of embryo collection teams and

embryo production teams

1. In order to be given approval each embryo collection team shall comply with

the following requirements

1.1. the collection, processing and storage of embryos shall be carried out either

by a team veterinarian or under his responsibility by one or more technicians who are

competent and trained by the team veterinarian in methods and techniques of hygiene

and in techniques and principles of disease control;

1.2. the team veterinarian shall be responsible for all team operations, including

amongst others

(a) verification of the identity and health status of the donor animal;

(b) sanitary handling and surgery of donor animals;

(c) disinfection and hygienic procedures;

(d) keeping records which show

(i)

the species, breed, date of birth and identification of each donor

animal;

(ii) the health history and all diagnostic tests and the results thereof,

treatments and vaccinations carried out on donor animals;

(iii) the place and date of collecting, processing and storing of oocytes,

ova and embryos;

(iv) the identification of embryos and details of their destination if

known;

1.3. the team shall be placed under the general supervision of the official

veterinarian, who shall inspect it at least once every calendar year to ensure, where

necessary based on records, standard operating procedures and internal audits,

compliance with the sanitary conditions regarding collection, processing and storage of

embryos and to verify all matters relating to the conditions of approval and supervision;

1.4. the team shall have at its disposal a permanently sited laboratory or a mobile

laboratory where embryos can be examined, processed and packed, consisting of at least

a work surface, an optical or stereo microscope and cryogenic equipment where

necessary;

1.5.

in the case of a permanently sited laboratory, it shall have

(a) a room where embryos can be processed which is physically separate from

the area used to handle the donor animals during collection;

(b) a room or area for cleansing and sterilising instruments, except when using

only single-use equipment;

(c) a room for storing embryos;

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1.6.

in the case of a mobile laboratory, it shall

(a) have a specially equipped part of the vehicle consisting of two separate

sections

(i)

one for the examination and processing of embryos which shall be a

clean section; and

(ii)

the other for accommodating equipment and materials used in

contact with the donor animals;

(b) use only single-use equipment, unless the sterilisation of its equipment

and the provision of fluids and other products necessary for the collection

and processing of embryos can be ensured by the contact with a

permanently sited laboratory;

1.7. the design and layout of buildings and laboratories shall be laid out and team

operations carried out so as to ensure that cross-contaminations of embryos are

prevented;

1.8.

the team shall have at its disposal storage premises which shall

(a) comprise at least one lockable room for the storage of ova and embryos;

(b) be easy to cleanse and disinfect;

(c) have permanent records of all incoming and outgoing ova or embryos;

(d) have storage containers for ova and embryos which are stored in a place

which is under the control of the team veterinarian and which is subject to

regular inspections by an official veterinarian;

1.9. the competent authority may authorise storage of semen in storage premises

referred to in point 1.8 provided that the semen

(a) meets the requirements of Directive 92/65/ EEC for either ovine and

caprine species or equine species, or of Council Directive 90/429/EEC of

26 June 1990 laying down the animal health requirements applicable to

intra-Community trade in and imports of semen of domestic animals of the

porcine species for porcine species;

(b) is stored for the operation of the team in separate storage containers in the

premises for storing approved embryos.

2. In order to be given approval each embryo production team shall also comply

with the following additional requirements

2.1. the team members have received adequate training on disease control and

laboratory techniques, particularly in procedures for working in sterile conditions;

2.2. the team shall have at its disposal a permanently sited laboratory which shall

(a) have adequate equipment and facilities, including separate rooms for

-

recovering oocytes from ovaries,

-

processing oocytes, ova and embryos,

-

storing embryos;

(b) have a laminar-flow or other suitable facilities where all technical

operations associated with specific sterile conditions (processing of ova,

embryos and semen) are conducted.

However, the centrifugation of semen may be carried out outside the

laminar-flow facility or other facility, as long as full hygienic precautions

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are taken;

2.3. where ova and other tissues are to be collected in a slaughterhouse, it shall

have at its disposal suitable equipment for the collection and transport of the ovaries

and other tissues to the processing laboratory in a hygienic and safe manner.

CHAPTER II

Conditions applicable to donor animals

I.

Conditions applicable to donor stallions

1. In order to be used for the collection of semen, the donor stallion shall, to the

satisfaction of the centre veterinarian, meet the following requirements

1.1. it shall not show any clinical sign of an infectious or contagious disease at

the time of admission and on the day the semen is collected;

1.2. it shall come from the territory or, in the case of regionalisation, from the part

of the territory of a Member State or a third country and from a holding under veterinary

supervision each of which satisfy the requirements of Directive 90/426/EEC;

1.3. it shall be kept for 30 days prior to the date of semen collection in holdings

where no equine has shown any clinical sign of equine viral arteritis or contagious

equine metritis during that period;

1.4. it shall not be used for natural mating during the 30 days prior to the first

semen collection and during the collection period;

1.5. it shall be subjected to the following tests, carried out and certified in a

laboratory which is recognised by the competent authority and has the tests referred to

hereinafter included in its accreditation in accordance with Article 12 of Regulation

(EC) No 882/2004 of the European Parliament and of the Council, according to the

programme provided for in point 1.6

(a) an agar-gel immuno-diffusion test (Coggins test) or an ELISA for equine

infectious anaemia with negative result;

(b) a test for the isolation of the equine arteritis virus or the detection of its

genome by polymerase chain reaction (PCR) or real-time PCR carried out

with negative result on an aliquot of the entire semen of the donor stallion,

unless the donor stallion has reacted with negative result at a serum

dilution of one in four in a serum neutralisation test for equine viral

arteritis;

(c) an agent identification test for contagious equine metritis, carried out

with negative result in each case on three specimens (swabs) taken from

the donor stallion on two occasions with an interval of not less than seven

days, and in no case earlier than seven days (systemic treatment) or 21

days (local treatment) after possible antimicrobial treatment of the donor

stallion, from at least the following sites

-

the penile sheath (prepuce),

-

the urethra,

-

the fossa glandis.

The specimens shall be placed in transport medium with activated charcoal, such as

Amies medium, before dispatch to the laboratory.

The specimens shall be subjected to at least one of the following tests

(i)

culture under microaerophilic conditions for at least 7 days for the

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isolation of Taylorella equigenitalis, set up within 24 hours after taking the

specimens from the donor animal, or 48 hours where the specimens are

kept cool during transport; or

(ii) polymerase chain reaction (PCR) or real-time PCR for the detection of

genome of Taylorella equigenitalis, carried out within 48 hours after

taking the specimens from the donor animal.

it shall be subjected to one of the following testing programmes

(a) if the donor stallion is continuously resident on the semen collection

centre for at least 30 days prior to the date of the first semen collection and

during the collection period, and no equidae on the semen collection centre

come into direct contact with equidae of lower health status than the donor

stallion, the tests required in point 1.5 shall be carried out on samples taken

from the donor stallion at least once a year at the beginning of the breeding

season or prior to the first collection of semen intended for trade in fresh,

chilled or frozen semen and not less than 14 days following the date of the

commencement of the residence period of at least 30 days prior to the date

of first semen collection;

(b) if the donor stallion is resident on the semen collection centre for at least

30 days prior to the date of the first semen collection and during the

collection period, but may leave the centre occasionally under the

responsibility of the centre veterinarian for a continuous period of less than

14 days, and/or other equidae on the collection centre come into direct

contact with equidae of lower health status, the tests required in point 1.5

shall be carried out as follows

(i)

at least once a year on samples taken from the donor stallion at

the beginning of the breeding season or prior to the first collection of

semen intended for trade in fresh, chilled or frozen semen and not

less than 14 days following the date of the commencement of the

residence period of at least 30 days prior to the date of first semen

collection; and

(ii)

during the period of collection of semen intended for trade in fresh,

chilled or frozen semen as follows

-

the test required in point 1.5(a) on samples taken not more than

90 days prior to the collection of semen for trade,

-

the test required in point 1.5(b) on samples taken not more than

30 days prior to the collection of semen for trade, unless the

non-shedder state of a donor stallion is confirmed by virus

isolation test, PCR or real-time PCR carried out on samples of

an aliquot of the entire semen taken not more than 6 months

prior to the collection of semen for trade and the donor stallion

has reacted with positive result at a serum dilution of at least

one in four in a serum neutralisation test for equine viral

arteritis,

-

the test required in point 1.5(c) on samples taken not more than

60 days prior to the collection of semen for trade, which in the

case of PCR or real-time PCR may be carried out on three

specimens (swabs) taken on a single occasion;

(c) if the donor stallion does not meet the conditions in points (a) and (b) and

the semen is collected for trade in frozen semen, the tests required in point

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1.5 shall be carried out on samples collected from the donor stallion as

follows

(i)

at least once a year at the beginning of the breeding season;

(ii)

during the storage period provided for in point 1.3(b) of Section I

of Chapter III and before the semen is removed from the centre or

used, on samples taken not earlier than 14 days and not later than 90

days following the date of collection of the semen.

By way of derogation from point (ii) of the first sub-paragraph, post-

collection sampling and testing for equine viral arteritis as described in

1.5(b) is not required in case the non-shedder state of a seropositive donor

stallion is confirmed by virus isolation test, PCR or real-time PCR carried

out with negative result on samples of an aliquot of the entire semen of the

donor stallion taken twice a year at an interval of at least four months and

the donor stallion has reacted with positive result at a serum dilution of at

least one in four in a serum neutralisation test for equine viral arteritis.

1.7. if any of the tests provided for in point 1.5 is positive, the donor stallion shall

be isolated, and the semen collected from it since the date of the last negative test shall

not be subject for trade with the exception, for equine viral arteritis, of semen from

every ejaculate which has undergone the equine arteritis virus isolation test with

negative result.

Semen collected from all other stallions at the semen collection centre since the date

when the last sample was collected that gave a negative result in one of the tests

provided for in point 1.5. shall be kept in separate storage and shall not be subject for

trade until the health status of the semen collection centre has been restored and the

semen stored has undergone the appropriate official investigations to rule out the

presence in the semen of pathogens causing diseases mentioned in point 1.5;

1.8. semen collected from stallions at a semen collection centre subject to a

prohibition order in accordance with Article 4 or 5 of Directive 90/426/EEC shall be

kept in separate storage and shall not be subject for trade until the health status of the

semen collection centre has been restored by the official veterinarian in accordance with

Directive 90/426/ EEC and the semen stored has undergone the appropriate official

investigations to rule out the presence in the semen of pathogens causing diseases listed

in Annex A to Directive 90/426/EEC.

II.

Conditions applicable to male ovine and caprine donor animals

1. For all ovine and caprine animals admitted to a semen collection centre the

following requirements shall apply

1.1. they have been kept in quarantine for a period of at least 28 days in

accommodation specifically approved for the purpose by the competent authority, and

where only animals having at least the same health status are present (quarantine

accommodation);

1.2. prior to their stay in the quarantine accommodation, they have belonged to an

officially brucellosis-free ovine or caprine holding pursuant to Article 2 of Directive

91/68/EEC and they shall not be previously kept in a holding of a lower health status as

regards brucellosis;

1.3. they come from a holding where during the 60 days prior to their stay in the

quarantine accommodation they have undergone a serological test for contagious

epidydimitis (B. ovis) carried out in accordance with Annex D to Directive 91/ 68/

EEC or any other test with an equivalent documented sensitivity and specificity;

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1.4. they have undergone the following tests carried out on a blood sample collected

within the 28 days preceding the commencement of the period of quarantine specified

in point 1.1, with negative results in each case, except for the test for Border disease

referred to in point (c)(ii)

(a) for brucellosis (B. melitensis), a serological test carried out in

accordance with Annex C to Directive 91/68/EEC;

(b) for contagious epidydimitis (B. ovis), a serological test carried out in

accordance with Annex D to Directive 91/68/EEC, or any other test with

an equivalent documented sensitivity and specificity;

(c) for Border disease

(i)

a virus isolation test or a test for virus antigen; and

(ii)

a serological test to determine the presence or absence of antibodies

(antibody test).

The competent authority may authorise that the tests referred to in

this point are carried out on samples collected in the quarantine

accommodation. If such authorisation is granted, the period of

quarantine referred to in point 1.1 shall not commence before the

date of sampling. However, if any of the tests referred to in this point

prove positive, the animal concerned shall be immediately removed

from the quarantine accommodation. In the event of group isolation,

the quarantine period referred to in point 1.1 shall not commence for

the remaining animals until the animal which tested positive has

been removed;

1.5. they have undergone the following tests carried out on samples taken during

the period of quarantine specified in point 1.1, and at least 21 days after being admitted

to the quarantine accommodation, with negative results

(a) for brucellosis (B. melitensis), a serological test carried out in

accordance with Annex C to Directive 91/68/EEC;

(b) for contagious epidydimitis (B. ovis), a serological test carried out in

accordance with Annex D to Directive 91/68/EEC, or any other test with an

equivalent documented sensitivity and specificity;

1.6. they have undergone the tests for Border disease referred in points 1.4(c)(i) and

(ii) carried out on the blood samples taken during the period of quarantine specified in

point 1.1, and at least 21 days after being admitted to the quarantine accommodation.

Any animal (seronegative or seropositive) shall only be allowed entry to the semen

collection centre if no sero-conversion occurs in animals which tested seronegative

before the day of entry into the quarantine accommodation.

If sero-conversion occurs, all animals that remain seronegative shall be kept in

quarantine over a prolonged time, until there is no more sero-conversion in the group

for a period of three weeks from the day the sero-conversion occurred.

Serologically positive animals shall be allowed entry into the semen collection centre

subject to a negative result in a test referred in point 1.4(c)(i).

2. Animals shall only be admitted to the semen collection centre with the

express permission of the centre veterinarian. All movements into and out of the semen

collection centre shall be recorded.

3. No animals admitted to the semen collection centre shall show any clinical sign

of disease on the date of admission.

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All animals shall, without prejudice to point 4, have come from quarantine

accommodation, which on the day of dispatch of the animals to the semen collection

centre complies with the following conditions

(a) it is situated in an area in which there has been no outbreak of foot-and-

mouth disease for the past 30 days within a 10 kilometre radius;

(b) it has for the past three months been free from foot-and-mouth disease and

brucellosis;

(c) it has for the past 30 days been free from compulsory notifiable diseases as

defined in Article 2(b)(6) of Directive 91/68/EEC.

4. Provided, that the conditions set out in point 3 are complied with and the

routine tests referred to in point 5 have been carried out during 12 months prior to the

movement of the animals, animals may be moved from one approved semen collection

centre to another of equal health status, without isolation or testing if the transfer is

direct. The animal in question must not come into direct or indirect contact with cloven-

hoofed animals of a lower health status and the means of transport used shall be

disinfected before use. If an animal is moved from one semen collection centre to a

semen collection centre in another Member State that movement shall be carried out in

accordance with Directive 91/68/EEC.

5. All ovine and caprine animals kept at an approved semen collection centre

shall be subjected at least once every calendar year to the following tests, with negative

results

(a) for brucellosis (B. melitensis), a serological test carried out in accordance

with Annex C to Directive 91/68/ EEC;

(b) for contagious epidydimitis (B. ovis) a serological test carried out in

accordance with Annex D to Directive 91/68/ EEC, or any other test with

an equivalent documented sensitivity and specificity;

(c) for Border disease, the antibody test referred to in point 1.4(c)(ii) which

is applied only to seronegative animals.

6. All tests referred to in this section shall be carried out by an approved

laboratory.

7. If any of the tests described in point 5 is positive, the animal shall be

isolated and the semen collected from it since the date of the last negative test shall not

be subject for trade.

The animal referred to in the first paragraph shall be removed from the centre,

except in the case of Border disease, in which case the animal shall be subjected with

negative result to a test referred in point 1.4(c)(i).

Semen collected from all other animals at the semen collection centre since the date

when the last sample was collected that gave a negative result in one of the tests

described in point 5 shall be kept in separate storage and shall not be subject for trade

until the health status of the semen collection centre has been restored and the semen

stored has undergone the appropriate official investigations to rule out the presence in

the semen of pathogens causing diseases mentioned in point 5.

8. Semen shall be obtained from animals which

(a) show no clinical signs of disease on the date the semen was collected;

(b) during the 12 months prior to the date of the collection of the semen

(i)

either have not been vaccinated against foot-and-mouth disease; or

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(ii)

have been vaccinated against foot-and-mouth disease at least 30

days prior to the collection, in which case 5% (with a minimum of

five straws) of each semen collection shall be submitted to a virus

isolation test for foot-and-mouth disease with negative results;

(c) have been kept at an approved semen collection centre for a continuous

period of at least 30 days prior to the date of collection of the semen, in

the case of collection of fresh semen;

(d) meet the requirements laid down in Articles 4, 5 and 6 of Directive 91/

68/EEC;

(e) if kept on holdings referred to in the first indent of Article 11(2), had

undergone with negative results during the 30 days prior to the date of

collection of the semen

(i)

a serological test for brucellosis (B. melitensis) carried out in

accordance with Annex C to Directive 91/68/EEC;

(ii)

a serological test for contagious epididymitis (B. ovis) carried out in

accordance with Annex D to Directive 91/68/EEC, or any other test

with an equivalent documented sensitivity and specificity;

(iii)

a test for the Border disease virus;

(f)

shall not be used for natural breeding during at least 30 days prior to the

date of first semen collection and between the date of the first sample

referred to in points 1.5 and between the date of the first sample referred to

in points 1.5 and 1.6 or in point (e) and until the end of the collection

period.

9. Semen collected from male ovine and caprine donor animals at a semen

collection centre or holding referred to in first indent of Article 11(2) subject to a

prohibition on animal health grounds in accordance with Article 4 of Directive 91/68/

EEC shall be kept in separate storage and shall not be subject for trade until the health

status of the semen collection centre or the holding has been restored by the official

veterinarian in accordance with Directive 91/ 68/EEC and the semen stored has

undergone the appropriate official investigations to rule out the presence in the

semen of pathogens causing diseases listed in Annex B(I) to Directive 91/68/EEC.

CHAPTER III

Requirements applicable to semen, ova and embryos

I.

Conditions for the collection, processing, preservation, storage and transport of

semen

1.1. Where, without prejudice to Directive 2001/82/EC of the European Parliament

and of the Council, antibiotics or a mixture of antibiotics are added with a bactericidal

activity at least equivalent to that of the following mixtures in each ml of semen

gentamicin (250 icin tylosin (50 in (5lincomycin-spectinomycin (150/300 -

spectinomycin (150/300 ibiotics are added with alincomycin-spectinomycin (150/300-

spectinamikacin (75 cin (divekacin (25 acin (25 ctinomycin (150/300 ibiotics are added

with a bacteion shall be stated in the health certificate referred to in the fourth indent of

Article 11(2).

1.2. All instruments used for the collection, processing, preservation or freezing

of semen shall be either disinfected or sterilised as appropriate before use, except for

single-use instruments.

1.3.

Frozen semen shall

LAID DOWN IN SPECIFIC COMMUNITY ACTS

(a) be placed and stored in storage containers

(i)

which have been cleansed and disinfected or sterilised before use,

or are single-use containers;

(ii)

with a cryogenic agent; which shall not be previously used for

other products of animal origin;

(b)

prior to dispatch or use, be stored in approved conditions for a minimum

period of 30 days from the date of collection.

1.4.

Semen to be subject for trade shall

(a) be transported to the Member State of destination in transport

containers which have been cleansed and disinfected or sterilised

before use, or are single-use containers, and which have been

sealed and numbered prior to dispatch from the approved semen

collection or storage centres;

(b) be marked in such a way that the number on the straws or other

packages coincides with the number on the health certificate

referred to in the fourth indent of Article 11(2) and with the

container in which they are stored and transported.

II.

Conditions for ova and embryos

1. Collection and processing of in vivo derived embryos

In vivo derived embryos shall be conceived as a result of artificial insemination with

semen meeting the requirements of this Directive and shall be collected, processed and

preserved in accordance with the following

1.1. Embryos shall be collected and processed by an approved embryo collection

team, without coming into contact with any other batch of embryos not complying with

the requirements of Directive 92/65/EEC.

1.2. Embryos shall be collected in a place, which is separated from other parts of

the premises or holding where the embryo is collected and which shall be in good repair

and constructed with materials which permit its effective and easy cleansing and

disinfection.

1.3. Embryos shall be processed (examined, washed, treated and placed in identified

and sterile straws, ampoules or other packages) in either a permanently sited laboratory

or a mobile laboratory, which, as regards susceptible species, is situated in an area in

which there has been no outbreak of foot-and-mouth disease for the past 30 days

within a 10 kilometre radius.

1.4. All equipment used to collect, handle, wash, freeze and store embryos shall

either be sterilised or properly cleansed and disinfected prior to use according to the

IETS Manual, or be single-use equipment.

1.5. Any biological product of animal origin used in the media and solutions for

collection, processing, washing or storage of embryos shall be free of pathogenic micro-

organisms. Media and solutions used in the collection, freezing and storage of embryos

shall be sterilised by approved methods according to the IETS Manual and handled in

such a manner as to ensure that sterility is maintained. Antibiotics might be added, when

appropriate, to collection, processing, washing and storage media according to the IETS

Manual.

1.6. The cryogenic agents used for preservation or storage of embryos shall not be

previously used for other products of animal origin.

1.7.

Each embryo straw, ampoule or other package shall be clearly identified by

LAID DOWN IN SPECIFIC COMMUNITY ACTS

labels according to the standardised system according to the IETS Manual.

1.8. The embryos shall be washed and have an intact zona pellucida, or the

embryonic capsule in case of equine embryos, before and immediately after washing. In

accordance with the IETS Manual, the standard washing procedure shall be modified to

include additional washes with the enzyme trypsin where recommended for the

inactivation or removal of certain pathogens.

1.9.

Embryos from different donor animals shall not be washed together.

1.10. The zona pellucida of each embryo, or the embryonic capsule in case of equine

embryos, shall be examined over its entire surface area at not less than 50 ×

magnification and certified to be intact and free of adherent material.

1.11. Embryos of a batch that has successfully undergone the examination set out in

point 1.10 shall be placed in a sterile straw, ampoule or other package marked in

accordance with point 1.7 which shall be sealed immediately.

1.12. Each embryo shall, where appropriate, be frozen as soon as possible and

stored in a place which is under the control of the team veterinarian.

1.13. Each embryo collection team shall submit for official examination for bacterial

and viral contamination routine samples of non-viable embryos or ova, flushing fluids

or washing fluids resulting from its activities according to the IETS Manual.

1.14. Each embryo collection team shall keep a record of its activities in respect of

embryo collection for a period of two years after the embryos have been the subject of

trade or import, including

(a) the breed, age and individual identification of the donor animals

concerned;

(b) the place of collection, processing and storage of embryos collected by the

team;

(c) the identification of the embryos together with details of the consignee of

the shipment.

2. Collection and processing of ova, ovaries and other tissues, with the aim of

producing in vitro derived embryos

The conditions set out in points 1.1 to 1.14 shall apply mutatis mutandis to the

collection and processing of ova, ovaries and other tissues for use in in vitro fertilisation

and/or in vitro culture. In addition, the following shall apply

2.1. The competent authority shall have knowledge of, and authority over, the

holding(s) of origin of the donor animals.

2.2. When ovaries and other tissues are collected at a slaughterhouse, either from

individual animals or from batches of donors (batch collection), the slaughterhouse

shall be officially approved in accordance with Regulation (EC) No 854/ 2004 of the

European Parliament and of the Council of 29 April 2004 laying down specific rules for

the organisation of official controls on products of animal origin intended for human

consumption and under the supervision of a veterinarian whose responsibility it is to

ensure that ante-mortem and post-mortem inspections of potential donor animals are

carried out and to certify them to be free of signs of the relevant contagious diseases

transmissible to animals. The slaughterhouse shall, as regards susceptible species, be

situated in an area in which there has been no outbreak of foot-and-mouth disease for

the past 30 days within a 10 kilometre radius.

2.3.

Batches of ovaries shall not be brought into the processing laboratory until post-

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mortem inspection of donor animals is completed.

2.4. Equipment for removal and transport of ovaries and other tissues shall be

cleansed and disinfected or sterilised before use and exclusively used for these

purposes.

3. Processing of in vitro derived embryos

The conditions laid down in points 1.1 to 1.14 shall apply mutatis mutandis to the

processing of in vitro derived embryos. In addition, the following shall apply

3.1. In vitro derived embryos shall be conceived as a result of in vitro

fertilisation with semen meeting the requirements of Directive 92/65/EEC.

3.2. After the in vitro culture period is completed but prior to freezing, storage

and transport of the embryos, they shall be washed and undergo the treatments

referred to in points 1.8, 1.10 and 1.11.

3.3. Embryos from different donor animals, in the case of individual animal

recovery, or from different batch collections shall not be washed together.

3.4. Embryos from different donor animals, in the case of individual animal

recovery, or from different batch collections shall not be stored in the same straw,

ampoule or other package.

4. Processing of micromanipulated embryos

Prior to any micromanipulation which compromises the integrity of the zona

pellucida, all embryos or ova shall be collected and processed according to the sanitary

conditions set out in points 1, 2 and 3. In addition, the following conditions shall apply

4.1. Where micromanipulation of the embryo which involves penetration of the

zona pellucida is carried out, this shall be done in suitable laboratory facilities under

supervision of an approved team veterinarian.

4.2. Each embryo collection team shall keep records of its activities according to

point 1.14, including details of micromanipulation techniques which involve penetration

of the zona pellucida and which have been performed on the embryos. In the case of

embryos derived by in vitro fertilisation, the identification of the embryos may be done

on the basis of a batch, but shall contain details of the date and place of collection of

ovaries and/or ova. It shall also be possible to identify the holding of origin of the donor

animals.

5. Storage of embryos

5.1. Each embryo collection and production teams shall ensure that the embryos are

stored at suitable temperatures in storage premises referred to in point 1.8 of Section III

of Chapter I.

5.2. Frozen embryos shall, prior to dispatch, be stored in approved conditions for a

minimum period of 30 days from the date of their collection or production.

6. Transport of embryos

6.1. Embryos to be subject for trade shall be transported to the Member State of

destination in containers which have been cleansed and disinfected or sterilised before

use, or are single-use containers, and which have been sealed and numbered prior to

dispatch from the approved storage premises.

6.2. The straws, ampoules or other packages shall be marked in such a way that the

number on the straws, ampoules or other packages coincides with the number on the

health certificate referred to in the third indent of Article 11(3) and with the container in

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which they are stored and transported.

CHAPTER IV

Requirements applicable to donor females

1. Donor females shall only be used for the collection of embryos or ova if they

and the holdings from which they originate meet, to the satisfaction of the official

veterinarian, the requirements of the relevant Directives on intra-Union trade in live

animals for breeding and production for the species concerned.

2. In addition to the requirements laid down in Directive 64/ 432/EEC, donor

females of porcine species shall, except in vivo derived embryos subject to a trypsin

treatment, comply with the requirements for Aujeszky’s disease laid down in

accordance with Article 9 or 10 of that Directive.

3. The provisions of Directive 91/68/EEC shall apply to donor females of ovine

and caprine species.

4. In addition to the requirements laid down in Directive 90/ 426/EEC, donor

mares shall

4.1. not be used for natural breeding during at least 30 days prior to the date of

collection of ova or embryos and between the date of the first sample referred to in

points 4.2 and 4.3 and the date of the collection of ova and embryos;

4.2. be subjected with negative result to an agar-gel immuno-diffusion test (Coggins

test) or an ELISA for equine infectious anaemia carried out on a blood sample taken not

less than 14 days following the date of the commencement of the period of at least 30

days referred to in point 4.1 and not more than 90 days prior to the collection of ova or

embryos for trade;

4.3. be subjected to an agent identification test for contagious equine metritis,

carried out with negative result in each case in a laboratory referred to in point 1.5

of Chapter (II)(I) on at least two specimens (swabs) taken from the donor mare in no

case earlier than seven days (systemic treatment) or 21 days (local treatment) after

possible antimicrobial treatment of the donor mare, from at least the following sites

-

the mucosal surfaces of the clitoral fossa,

-

the clitoral sinuses.

The specimens shall be taken during the period referred to in point 4.1 on two

occasions with an interval of not less than seven days in the case of the test referred to

in point (i), or on one occasion in the case of the test referred to in point (ii).

The specimens shall be placed in transport medium with activated charcoal, such as

Amies medium, before dispatch to the laboratory.

The specimens shall be subjected to at least one of the following tests

(i)

culture under microaerophilic conditions for at least seven days for the

isolation of Taylorella equigenitalis, set up within 24 hours after taking the

specimens from the donor animal, or 48 hours where the specimens are

kept cool during transport; or

(ii)

polymerase chain reaction (PCR) or real-time PCR for the detection of

genome of Taylorella equigenitalis, carried out within 48 hours after taking

the specimens from the donor animal.

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Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 5 Trade in apes. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

(1) The competent authority shall ensure that trade in apes

(simiae and prosimiae) is restricted solely to animals consigned from

and to a body, institute or centre approved by the competent authority

in accordance with rule 13 and that such animals are accompanied by

a veterinary certificate corresponding to the specimen in Schedule E,

the declaration in which must be comple ted by the official

veterinarian of the body, institute or centre of origin to guarantee the

animals’ health.

(2) The competent authority may, by way of derogation from sub-

rule (1), authorize the acquisition by an approved body, institute or

centre of apes belonging to an individual.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Schedule E — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

Part 1 - Health Certificate for trade in animals from holdings (ungulates, birds

vaccinated against avian influenza, lagomorphs, dogs, cats and ferrets) 92/65 EI

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Part 2 - Health certificate for trade in bees and bumble bees 92/65 EII

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Part 3 - Health certificate for trade in animals, semen, ova and embryos from

approved bodies, institutes or centres - 92/65 EIII

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Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 6 Trade in ungulates. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

Without prejudice to the provisions of rules 14 and 15, the

competent authority shall ensure that ungulates of species other than

those referred to in paragraph (a) of the definition ‘animals’ in rule 2,

may be the subject of trade only if they meet the following

requirements

(a) in general they -

(i) must be identified in accordance with Community

rules and Maltese legislation to ensure

traceability;

(ii) must not be intended for slaughter under a

programme for the eradication of an infectious

disease;

(iii) must not have been vaccinated against foot-and-

mouth disease and must satisfy the relevant

requirements of the Foot-and-Mouth Disease

(Control Measures) Rules and the Foot-and-Mouth

Disease (Control Measures) Rules as well as

regulation 4 of the Animal Health Problems

affecting Intra-Community Trade in Bovine

Animals and Swine Regulations;

(iv)

must come from a holding, referred to in

regulation 3(2)(b) and (c) of the Animal Health

Problems affecting Intra-Community Trade in

Bovine Animals and Swine Regulations, which is

not the subject of animal health measures,

particularly those taken under the Foot-and-Mouth

Disease (Control Measures) Rules, the Foot-and-

Mouth Disease (Control Measures) Rules and the

Health Conditions governing Intra-Community

Trade in Ovine and Caprine Animals Rules, as

well as Directive 80/217/EEC, and have been

kept therein permanently since birth or for the

last thirty days before dispatch;

(v)

must be accompanied by a certificate

corresponding to the specimen in Part I of

Schedule E, bearing the declaration in Schedule;

(b) in the case of ruminants

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(i)

they must come from an officially tuberculosis-

free and officially brucellosis-free herd in

accordance with the Animal Health Problems

affecting Intra-Community Trade in Bovine

Animals and Swine Regulations or the Health

Conditions governing Intra-Community Trade in

Ovine and Caprine Animals Rules and satisfy, as

regards animal health rules, the relevant

requirements laid down for the bovine species in

regulation 3(2)(c), (d), (f), (g) and (h) of Directive

64/42/ EEC or rule 3 of Health Conditions

governing Intra-Community Trade in Ovine and

Caprine Animals Rules;

(ii)

where they do not come from a herd meeting the

conditions laid down in paragraph (i), they must

come from a holding in which no case of

brucellosis or tuberculosis has been recorded in the

forty-two days preceding loading of the animals

and in which the ruminants have in the thirty days

prior to dispatch undergone with negative results

a test for brucellosis and tuberculosis;

(iii)

in accordance with the procedure laid down in

Article 26 of Directive 92/65/EEC, provisions may

be adopted regarding leucosis;

(c) in the case of suidae

(i) they must not have come from an area which is

the subject of prohibition measures associated

with the presence of African swine fever in

accordance with regulation 9 of the Animal Health

Problems affecting Intra-Community Trade in

Bovine Animals and Swine Regulations;

(ii) they must come from a holding which is not

subject to any of the restrictions laid down in

Directive 80/217/EEC as a result of classical

swine fever;

(iii) they must come from a brucellosis-free holding in

accordance with the Animal Health Problems

affecting Intra-Community Trade in Bovine

Animals and Swine Regulations and satisfy the

relevant animal health requirements laid down for

swine in the said regulations;

(iv) where they do not come from a herd meeting the

conditions set out in the previous sub-paragraph,

they must, in the thirty days prior to their dispatch,

have undergone with negative results a test

designed to show the absence of antibodies to

brucellosis;

(d) the testing requirements referred to in this rule and their

criteria shall be established in accordance with the

procedure laid down in Article 26 of Directive 92/65/

EEC;

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(e) under the procedure laid down in rule 12, the health

certificates, specimens of which are reproduced in

Schedule F, may be amended or supplemented, in

particular in order to take account of the requirements of

this rule;

(f)

the trader, owner, the keeper, the dealer, the importer, the

consignee, the carrier, the retailer or any other person

authorised under the Act to dispose of live animals shall

be responsible for the animals being traded and shall

abide by all the provisions of these rules and of article

37(1) of the Act at all times.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Schedule F — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

CD64/432 as transposed into SL437.48, Council Directive 64/432/EEC of 26 June

1964 on animal health problems affecting intra-Community trade in bovine animals

and swine

Animal Health Problems affecting Intra-Community Trade in Bovine Animals and

Swine Regulations

CD88/407 as transposed into SL437.99, Council Directive 88/407/EEC of 14 June

1988 laying down the animal health requirements applicable to intra-Community

trade in and imports of deep-frozen semen of domestic animals of the bovine species

Animal Health Conditions Applicable to Intra-Community Trade and Imports from

Third Countries of Deep-Frozen Semen of Domestic Animals of the Bovine Species

Rules

CD89/556 as transposed into SL437.100, Council Directive 89/556/EEC of 25

September 1989 on animal health conditions governing intra-Community trade in

and importation from third countries of embryos of domestic animals of the bovine

species

Animal Health Conditions Governing Intra-Community Trade and Importation from

Third Countries of Embryos of Domestic Animals of the Bovine Species Rules

CD90/426 as transposed into SL.437.60, Council Directive 90/426/EEC of 26 June

1990 on animal health conditions governing the movement and import from third

countries of Equidae

Animal Health Conditions governing the Movement and Import from Third

Countries of Equidae Rules

CD90/429 as transposed into SL437.102, Council Directive 90/429/EEC of 26

June 1990 laying down the animal health requirements applicable to intra-

Community trade in and imports of semen of domestic animals of the porcine species

Animal Health Conditions (Intra-Community Trade and Imports from Third

Countries of Deep-Frozen Semen of Domestic Animals of the Porcine Species) Rules

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Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 7 Requirements in the case of birds subject to trade. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

The competent authority shall ensure that birds, other than

those referred to in the Animal Health Conditions (Intra-Community

Trade and Imports from Third Countries of Poultry and Hatching

Eggs) Rules, may be the subject of trade only if they meet the

following requirements

(a) in general they must

(i)

come from a holding in which avian influenza has

not been diagnosed in the thirty days preceding

the dispatch;

(ii)

come from a holding or an area not subject to

restrictions under measures to be applied to

combat Newcastle disease.

Pending the implementation of the Community

measures referred to in the Animal Health

Conditions (Intra-Community Trade and Imports

from Third Countries of Poultry and Hatching

Eggs) Rules, national requirements for combating

Newcastle disease shall continue to apply, in

compliance with the general provisions of the

Treaty;

(iii)

have, in accordance with rule 10(1) of the

Principles Governing the Organisation of

Veterinary Checks on Animals Entering the

Community from Third Countries via Border

Inspection Posts of the Territory of Malta

Regulations, been quarantined, if they have been

imported from a third country, in the quarantine of

the competent authority or approved quarantine or

in the holding to which they were taken after they

entered the territory of the Community;

(b) in addition, psittacidae must

(i)

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 recognized under the procedure

provided for in Article 26 of Directive 92/65/EEC

must be at least two months;

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(ii)

be identified in accordance with rule 3(1)(c) of

the Veterinary and Zootechnical Checks applicable

in Trade with Member States in certain Live

Animals and Products Regulations.

The methods for identifying psittacidae, and in

particular sick psittacidae, shall be established

under the procedure provided for in Article 26 of

Directive 92/65/ EEC;

(iii)

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.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Schedule G — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

Declaration

I, the undersigned (official veterinarian), certify that the ruminant(s)( 1 )/suida(e)( 1 )

other than that ( 1 )/those( 1 ) covered by Directive 64/432/EEC

............................................... belong/belongs( 1 ) to the (species) At the time of

examination, do( 1 )/does not( 1 ) show any clinical sign of any disease to which it( 1 )/

they( 1 ) is( 1 )/are( 1 ) susceptible;

Come(s) from an officially tubercolosis-free( 1 )/officially brucellosis-free( 1 ) or

brucellosis-free herd( 1 )/ holding( 1 ) not subject to swine fever restrictions or from a

holding where it( 1 )/ they( 1 ) was( 1 )/ were( 1 ) subjected with negative results to the

test(s) laid down in Article 6(2)(b) of Directive 92/65/EEC.

( 1 ) Delete where inapplicable;

Signature of Official veterinarian.

Competent authority

Date

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 8 Requirements in the case of bees subject to trade. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

The competent authority shall ensure that bees (Apis

melifera) may be the subject of trade only if they meet the following

requirements

(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 thirty

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 laid down in Article

26 of Directive 92/65/EEC, and after consulting the

Scientific Veterinary Committee, the requirements

applied to bees (Apis melifera) or equivalent

requirements may be applied to bumble bees;

(b)

they are accompanied by a health certificate

corresponding to the specimen in Schedule E, the

declaration in which is completed by the competent

authority to certify that the requirements laid down in

paragraph (a) are met.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Schedule H — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

(Part A)

All species of the order Scorpiones (scorpions) except those belonging to the

species Euscorpius sicanus.

Spiders belonging to the order Solifugae (camel spider), the species Atrax

robustus (funnel web spider) and others that may be poisonous to the extent

of killing a human being with their poison.

All

species

of

the

orders

Scutigeromorpha,

Lithobiomorpha,

Craterostigmomorpha, Scolopen-romorpha and Geophilomorpha (centipedes)

that may be poisonous to the extent of killing a human being with their poison

except those belonging to the native species occurring in the Maltese natural

habitat.

All species of poisonous reptiles with specific reference to the Crotalids,

Cobras, Mambas and Aspids.

All species of the order Crocodilia (crocodiles and alligators) and Varanus

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komodensis (komodo dragon).

All species of poisonous amphibians.

All species of the order Dasyuro morphia (marsupial carnivores as the

dasyurids, the tasmanian devil, thylacine, numbat, et. al.).

All species of the order Pera mele morphia (bandicoots et. al.).

All species of the family Nandiniidae (the African palm civet et. al.).

All species of the family Felidae (felines) except those belonging to Felis

catus domesticus.

All species of the family Viverridae (civets et. al.) including all subspecies of

the subfamily Prinonodontidae (the Asiatic linsangs et. al.).

All species of the family Hyaenidae (hyenas et. al.).

All species of the family Eupleridae (Malagasy carnivores et. al.).

All species of the family Herpestidae (mongooses et. al.).

All species of the family Canidae (dogs and wolves) except those belonging to

Canis lupus familiaris but not the Dingo.

All species of the family Ursidae (bears et. al.).

All species of the family Ailuridae (red panda et. al.).

All species of the family Odobenidae (walruses et. al.).

All species of the family Otariidae (sea lions et. al.).

All species of the family Phocidae (seals et. al.).

All species of the family Rhinocerotidae (rhinos).

All species of the family Hippopotamidae (hippos).

All species of the family Proboscinae (elephants).

All species of the order Cetacea (cetaceans).

All species of the family Hylobatidae (gibbons et. al.).

All species of the family Hominidae or Ponginae, (great apes including

gorillas, chimpanzees and orangutangs et. al.) except those belonging to Homo

sapiens.

All species of the genus Popio (baboons et. al.).

All species of the genus Mandrillus (mandrills et. al.).

(Part B)

All members of the Order Squamata not included in Schedule A and not part of

the local fauna.

All members of the Order Testudines.

All the members of Amphibians not included in Schedule A and not part of

the local fauna.

Members of the class Aves, of the Orders Accipitriformes, Falconiformes and

the Order Psittaciformes except budgerigars, cockatiels and lovebirds.

Members of the Order Artiodactyla not mentioned in Schedule A and not

normally domesticated. This excludes bovines, ovines, caprines and pigs

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normally kept in farming practice. Dwarf and exotic breeds of these farming

animals accepted by the Director will be registered under these rules. The

carcasses of these animals will not enter the food chain.

The members of the Order Perissodactyla except domestic equines.

All the members of the Order Primates not included in Schedule A and not

including Homo sapiens.

All the members of the Orders Chiroptera, Dermoptera, Didelphimorphia,

Diprotodontia, Hyracoidea, Insectivora, Macroscelidea, Microbiotheria,

Monotremata, Notoryctemorphia, Puacituberculata, Pholidota, Scandentia,

Sirenia, Tubulidentata, Xenarthra and not part of the local fauna.

All members of the Families Mephitidae, Procyonidae, Erethinzontidae,

Hystricidae, Aplodontiidae and Hydrochoeridae.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 9 Requirements in the case of lagomorphs subject to trade. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

(1) The competent authority shall ensure that lagomorphs

may be the subject of trade only if they meet the following

requirements

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

animals from a holding on which rabies is present or is

suspected of having been present within the last month;

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

shows clinical signs of myxomatosis.

(2) Rabbits travelling to Malta shall be accompanied by a health

certificate corresponding to the specimen in Schedule E,

supplemented by the following declaration

‘I the undersigned, ................................... certify that the

above consignment satisfies the requirements of Article

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9 of Directive 92/65/EEC and that the animals showed

no clinical sign of disease on examination.’.

This certificate must be issued by the official veterinarian or

by the veterinarian responsible for the holding of origin and

empowered for this purpose by the competent authority and for

industrial breeding, by the official veterinarian.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 10 Trade in mink and foxes. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

(1) All trade in mink and foxes which come from or have

been in contact with animals from a holding on which rabies is present

or is suspected of having been present within the previous six months,

inasmuch as no systematic vaccination programme is applied, is

prohibited.

(2)

To be the subject of trade, dogs, cats and ferrets shall

(a) satisfy the conditions set out in Article 6 and, where

applicable, in Article 7 of Regulation (EU) No 576/2013

of the European Parliament and of the Council of 12

June 2013 on the non-commercial movement of pet

animals;

(b) undergo a clinical examination carried out within forty-

eight hours prior to the time of dispatch of the animals

by a veterinarian authorised by the competent authority;

and

(c) be accompanied during transport to the place of

destination by a health certificate which

(i)

corresponds to the specimen in Part 1 of Schedule

E; and

(ii)

is signed by an official veterinarian who shall

attest that the veterinarian authorised by the

relative competent authority of the Member State

or country of despatch, has documented in the

relevant section of the identification document in

the format provided for in Article 21(1) of

Regulation (EU) No 576/2013 the clinical

examination carried out in accordance with

paragraph (b) showing, at the time of the clinical

examination, that the animals are fit to be

transported for the intended journey in accordance

with Council Regulation (EC) No 1/2005 of 22

December 2004 on the protection of animals

during transport and related operations.

(3) Without prejudice to sub-rules (1) and (2), the regulations on

quarantine for all carnivores, with the exception of the species

referred to in sub-rule (2), as well as quarantine primates, bats and

other animals susceptible to rabies covered by these rules which

cannot be shown to have been born on the holding of origin and kept

in captivity since birth, although the retention of those regulations

may not jeopardize the abolition of veterinary checks at the frontiers

between Member States.

(4)

The competent authority shall ensure that the costs of

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applying the serological test are borne by the owner or the importer,

trader or person responsible for the load.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 11 Semen, ova and embryos which are the subject of trade. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

(1) The competent authority shall ensure that, without

prejudice to the decisions to be taken in implementation of rules 21

and 23, only semen, ova and embryos meeting the conditions laid

down in sub-rules (2), (3), (4) and (5) are the subject of trade.

(2) Semen of the ovine, caprine and equine species must, 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, processed and stored with a view

to artificial insemination in a centre approved from the

health point of view in accordance with Schedule D

(CHAPTER I), or, in the case of ovine and caprine

animals by way of derogation from the above, in a

holding satisfying the requirements of the Health

Conditions governing Intra-Community Trade in Ovine

and Caprine Animals Rules;

(b)

have been collected from animals meeting the conditions

laid down in Schedule D (CHAPTER II);

(c) have been collected, processed, preserved, stored and

transported in accordance with Schedule D (CHAPTER

III);

(d) have been accompanied during transport to another

Member State by a health certificate corresponding to a

specimen to be determined in accordance with the

procedure referred to in Article 26 of Directive 92/65/

EEC.

(3) Ova and embryos of the ovine, caprine, equine and porcine

species must

(a) have been removed from donor females meeting the

conditions laid down in Schedule D (CHAPTER I) by a

collection team or have been produced by a production

team approved by the competent authority of the

Member State and satisfying the conditions to be

established in Schedule D (CHAPTER I) in accordance

with the procedure referred to in Article 26 of Directive

92/65/EEC;

(b) have been collected, processed and preserved in an

appropriate laboratory, stored and transported in

accordance with Schedule D (CHAPTER III);

(c) be accompanied during transport to another Member

State by a health certificate corresponding to a specimen

to be determined in accordance with the procedure

referred to in Article 26 of Directive 92/65/EEC.

Semen used for the insemination of donor females must

comply with the provisions of sub-rule (2) in the case of sheep, goats

and equids and with the provisions of the Animal Health Conditions

(Intra-Community Trade and Imports from Third Countries of Deep-

Frozen Semen of Domestic Animals of the Porcine Species) Rules

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for swine.

Any additional guarantees may be determined in accordance

with the procedures referred to in Article 26 of Directive 92/65/EEC.

(4) The approved centres referred to in sub-rule (2)(a) and the

approved teams referred to in sub-rule (3)(a) shall be registered by the

competent authority of the Member State concerned, each centre and

team being given a veterinary registration number.

The competent authority shall draw up and keep up to date a

list of the approved centres and teams and their veterinary registration

numbers within the territory of Malta and shall make this list

available to the other Member States and to the public.

Detailed rules for the uniform application of this paragraph

may be adopted in accordance with the procedures referred to in

Article 26 of Directive 92/65/EEC.

(5) The animal health requirements and the specimen health

certificates applicable to semen, ova and embryos of species not

mentioned in sub-rules (2) and (3) shall be established in accordance

with the procedure referred to in Article 26 of Directive 92/65/EEC.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 12 Organization of, and follow-up to, the checks to be carried out. S.L. 437.38 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

(1) The rules on checks established by the Veterinary and

Zootechnical Checks applicable in Trade with Member States in

certain Live Animals and Products Regulations shall apply, in

particular as regards the organization of, and follow-up to, the checks

to be carried out, to the animals, semen, ova and embryos covered by

these rules which are accompanied by a health certificate. Other

animals must come from holdings subject to the principles of the

Veterinary and Zootechnical Checks applicable in Trade with Member

States in certain Live Animals and Products Regulations as regards

checks on origin and destination.

(2) Regulation 10 of the Veterinary and Zootechnical Checks

applicable in Trade with Member States in certain Live Animals and

Products Regulations shall apply to animals, semen, ova and embryos

covered by these rules.

(3) For the purpose of trade, regulation 13 of the Veterinary and

Zootechnical Checks applicable in Trade with Member States in

certain Live Animals and Products Regulations shall extend to dealers

who keep, on a permanent or occasional basis, animals referred to in

rules 7, 9 and 10.

(4) The communication of the place of destination as provided for

in regulation 4(2) of the Veterinary and Zootechnical Checks

applicable in Trade with Member States in certain Live Animals and

Products Regulations shall, in respect of animals, semen, ova or

embryos accompanied by a health certificate in accordance with these

rules, take place using the TRACES system.

(5) 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

these rules, carry out any checks it deems appropriate.

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Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 13 Animals of species susceptible to diseases. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

(1) Trade in animals of species susceptible to the diseases

listed in Schedule A or to the diseases listed in Schedule B, and trade

in semen, ova or embryos of such animals consigned to and from

bodies, institutes or centres approved in accordance with Schedule C

shall be subject t o the production of a transport document

corresponding to the specimen in Schedule E. This document, which

must 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)

(a) To be approved, bodies, institutes or centres shall, as

regards notifiable diseases, submit to the competent

authority of the Member State where they are established

all relevant supporting documents relating to the

requirements contained in Schedule C.

(b) 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.

(c) The competent authority shall withdraw an approval in

accordance with point 3 of Schedule C.

(d) All approved bodies, institutes and centres shall be

registered and issued with an approval number

established by the competent authority.

(3) The competent authority shall draw up and keep up to date a

list of approved bodies, institutes and centres and their approval

numbers and shall make it available to the other Member States and to

the public.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 14 Voluntary or compulsory control or monitoring programme. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

(1) The competent authority may establish either directly or

through the breeders, a voluntary or compulsory control or monitoring

programme for one of the diseases referred to in Schedule B. It may

present the programme to the Commission outlining in particular

(a) the distribution of the disease in its territory,

(b) whether the disease is notifiable,

(c) the reasons for undertaking the programme, taking

account of its cost-effectiveness and the significance of

the disease,

(d) the geographical area in which the programme is to be

implemented,

(e) the status categories to be applied to establishments, the

requirements for each species when being introduced

into a holding and the test procedures to be used,

(f)

the programme monitoring procedures, including the

extent of the breeders’ involvement in implementing the

control or monitoring programme,

(g) the action to be taken if, for any reason, a holding loses

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its status,

(h) the measures to be taken if the results of the tests

carried out under the programme are positive,

(i)

the non-discriminatory nature of trade within the territory

of Malta with respect to intra-Community trade.

(2) Programmes referred to in sub-rule (1) shall be examined by

the Commission, and may be approved under the procedure provided

for in Article 26 of Directive 92/65/EEC. Under the same procedure,

the additional guarantees, general or limited, which may be required

in trade, and which shall not exceed the guarantees implemented

nationally, shall be defined at the same time or at the latest three

months after presentation of the programmes.

(3) The programmes submitted to the Commission may be

amended or supplemented under the procedure laid down in Article

26 of Directive 92/65/EEC. Under the same procedure, amendments

may be made to the guarantees referred to in sub-rule (2).

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 15 Where territory of Malta or part thereof is free from one of the diseases listed in Schedule B. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

(1) Where the competent authority considers that the

territory of Malta or part thereof is free from one of the diseases listed

in Schedule B to which the animals covered by these rules are

susceptible, it shall present to the 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,

(c) the period during which this disease was notifiable to the

competent authorities,

(d) the period over which the surveillance was carried out,

(e) where applicable, the period during which vaccination

against the disease has been prohibited and the

geographical area concerned by the prohibition,

(f)

the arrangements for verifying the absence of the

disease.

(2) The documentation referred to in sub-rule (1) shall be

examined by the Commission which shall submit to the Standing

Veterinary Committee a decision approving or rejecting the plan. If

the plan is accepted, the additional guarantees, general or specific,

which may be required in trade and which shall not exceed the

guarantees implemented nationally, shall be defined under the

procedure laid down in Article 26 of Directive 92/65/EEC.

Pending a decision, the relevant requirements needed in order

to maintain the then current status may be maintained in trade

dealings.

(3) The Commission shall be notified of any change in the

particulars specified in sub-rule (1). The guarantees defined in sub-

rule (2) may, in the light of such notification, be amended or

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withdrawn under the procedure laid down in Article 26 of Directive

92/65/EEC.

CHAPTER III

Provisions applicable to imports into the Community

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 16 Imports of animals, semen, ova and embryos covered by rules 17, 18, 19 and 20. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

(1) The conditions applicable to imports of animals,

semen, ova and embryos covered by rules 17, 18, 19 and 20 must be

at least equivalent to those laid down in Chapter II.

(2) With respect to cats, dogs and ferrets, import conditions

must be at least equivalent to those provided for in points (a) to (d) of

Article 10(1) and point (a) of Article 12 of Regulation (EU) No 576/

2013. (3) In addition to the conditions referred to in sub-rule (2),

dogs, cats and ferrets shall, during transport to the place of

destination, be accompanied by a health certificate, which is

completed and signed by an official veterinarian who shall attest that

a clinical examination was carried out within forty-eight hours prior

to the time of dispatch of the animals by a veterinarian authorised by

the competent authority who has verified that at the time of the

clinical examination, the animals were fit to be transported for the

intended journey.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 17 Uniform application of rule — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

(1) The following paragraphs shall apply for the purposes of

the uniform application of rule 16.

16. (2) Only animals and semen, ova and embryos referred to in

rule 11 which satisfy the following requirements may be imported

into the Community

(a) they must come from a third country on a list to be

drawn up in accordance with sub-rule (3)(a);

(b) they must be accompanied by the health certificate

corresponding to a specimen to be drawn up in

accordance with the procedure referred to in Article 26

of Directive 92/65/EEC, signed by the competent

authority of the exporting country and certifying that -

(i)

the animals -

-

meet the additional conditions or offer the

equivalent guarantees referred to in sub-rule

(4), and

-

come from approved centres, bodies,

institutes offering guarantees at least

equivalent to those in Schedule C;

(ii)

semen, ova and embryos come from approved

collection and storage centres or collection and

production teams offering guarantees at least

equivalent to those to be established in Schedule

D(I) in accordance with the procedure referred to

in Article 26 of Directive 92/65/EEC.

Pending the establishment of lists of third countries, approved

establishments listed in paragraph (b), animal health requirements

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and specimen health certificates as referred to in paragraphs (a) and

(b), the then current national rules shall continue to apply provided

they are not more favourable than those laid down in Chapter II.

(3) In accordance with the information received, there shall be

established

(a) in accordance with the procedure referred to in Article

26 of Directive 92/65/EEC, a list of third countries or

parts of third countries able to provide Member States

and the Commission with guarantees equivalent to those

provided for in Chapter II in relation to animals, semen,

ova and embryos; and

(b) a list of approved centres or teams as referred to in the

rule 11(2)(a) and (3)(a) situated in one of the third

countries appearing on the list referred to in paragraph

(a) above, and for which the competent authority is able

to give the guarantees provided for in rule 11(2) and (3).

The list of approved centres and teams referred to in this

paragraph and their veterinary registration numbers shall

be communicated to the Commission.

The approval of centres or teams must be immediately

suspended or withdrawn by the competent authority of

the third country where it no longer complies with the

conditions referred to in rule 11(2) and (3) and the

Commission must be immediately informed thereof;

(c) in accordance with the procedure referred to in Article

26 of Directive 92/65/EEC, the specific animal health

requirements, in particular for the protection of the

Community from certain exotic diseases, or guarantees

equivalent to those provided for in these rules.

The specific requirements and equivalent guarantees

established for third countries may not be more

favourable than those provided for in Chapter II.

(4) The list provided for in sub-rule (3) may include only third

countries or parts of third countries

(a) from which imports are not prohibited

(i)

as a result of the existence of one of the diseases

referred to in Schedule A or of any other disease

exotic to the Community,

(ii)

pursuant to Articles 6, 7 and 14 of Directive 72/

462/EEC and Article 17 of Directive 91/495/EEC

and of Directive 71/118/EEC as defined in

Schedule H or, in the case of the other animals

covered by these rules, under a decision taken in

accordance with the procedure laid down in

Article 26 of Directive 92/65/EEC, account being

taken of their state of health;

(b) which, in view of their legislation and the organization

of their veterinary services and inspection services, the

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powers of such services and the supervision to which

they are subject, have been recognized, in accordance

with Article 3(2) of Directive 72/462/EEC, as capable of

guaranteeing the implementation of their legislation in

force;

(c) the veterinary services of which are able to guarantee

that health requirements at least equivalent to those laid

down in Chapter II are being complied with.

(5) The competent authority of the third country shall allow

experts from the Commission and the Member States to carry out on-

the-spot inspections to verify whether the guarantees given by the

third country regarding the conditions of production and placing on

the market can be considered equivalent to those applied in the

Community. The experts from the Member States responsible for

these inspections shall be appointed by the Commission acting on a

proposal from the Member States. These inspections shall be made on

behalf of the Community, which shall bear the cost of any expenditure

in this connection.

(6) Pending the organization of the inspections referred to in

sub-rule (5), national rules applicable to inspection in third countries

shall continue to apply, subject to notification, through the Standing

Veterinary Committee, of any failure to comply with the guarantees

offered in accordance with sub-rule (3), found during these

inspections.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 18 Importation of animals, semen, ova and embryos into the Community. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

(1) The competent authority shall ensure that the animals,

semen, ova and embryos covered by these rules are imported into the

Community only if they

(a) are accompanied by a certificate to be drawn up by the

official veterinarian, the specimen certificate shall,

depending on the species, be drawn up under the

procedure laid down in Article 26 of Directive 92/65/

EEC;

(b) have satisfied the checks required by Directive 90/675/

EEC and the Principles Governing the Organisation of

Veterinary Checks on Animals Entering the Community

from Third Countries via Border Inspection Posts of the

Territory of Malta Regulations,

(c) have undergone, prior to shipment to Community

territory, a check by an official veterinarian to ensure that

the transport conditions specified in the Staging Posts

Regulations have been complied with, in particular as

regards watering and feeding,

(d) have, in the case of the animals referred to in rules 5 to

10, been quarantined before being placed on the market,

in accordance with detailed rules to be established under

the procedure laid down in Article 26 of Directive 92/65/

EEC.

(2) Pending the establishment of specific rules for this rule, the

national rules currently applicable to imports from third countries for

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which such requirements have not been adopted at Community level

shall continue to apply, provided they are not more favourable than

those laid down in Chapter II.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 19 Applicability of procedure laid down in Article 26 of Directive 92/65/ EEC. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

The following shall be decided under the procedure laid

down in Article 26 of Directive 92/65/EEC

(a) specific animal health requirements, for imports into the

Community, and the nature and content of accompanying

documents for animals intended for zoos, circuses,

amusement parks or experimental laboratories, according

to the species;

(b) additional guarantees to those provided for in respect of

the various animal species covered by these rules, to

protect the Community species concerned.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 20 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

(1) The rules laid down in the Principles Governing the

Organisation of Veterinary Checks on Products Entering the Territory

of Malta from Third Countries Regulations shall apply in particular to

the organisation of, and follow-up to the checks to be carried out by

the Member States and the safeguard measures to be applied in

accordance with the procedure referred to in regulation 19 of the said

regulations.

(2) Pending implementation of the decisions provided for in

regulation 8(6) of the Principles Governing the Organisation of

Veterinary Checks on Animals Entering the Community from Third

Countries via Border Inspection Posts of the Territory of Malta

Regulations, the relevant provisions of sub-regulations (1) and (2) of

the said regulation shall continue to apply, without prejudice to

compliance with the principles and rules referred to in sub-rule (1).

CHAPTER IV

Common final provisions

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 21 Specimens of certificates applicable to trade. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

All specimens of certificates applicable to trade and the

animal health conditions to be met in order for it to be possible to

trade in animals, semen, ova and embryos other than those covered by

rules 5 to 11 shall, where the need arises, be determined under the

procedure laid down in Article 26 of Directive 92/65/EEC. When

such modifications and amendments take place to the specimen

certificates, these amended versions shall be deemed to apply under

these rules in replacement of the present specimen certificates.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 22 Schedules. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

The Schedules to these rules are to be amended whenever the

relative annexes to Directive 92/65/EEC are amended under the

procedure laid down in Article 26 of the said Directive.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 23 Derogation from Chapter II. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

Under the procedure laid down in Article 26 of Directive

92/65/EEC, special requirements may be laid down, if appropriate, by

way of derogation from Chapter II, for the movement of circus and

fairground animals and for trade in animals, semen, ova and embryos

intended for zoos, without prejudice to the provisions relating to

circuses in the Animal Welfare Act.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 24 Health certificate. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

The competent authority shall allow the entry into Malta of

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the animals (including cage birds), 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, and the Commission

and the other Member States shall be informed accordingly.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 25 Non-applicability of derogation. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

The derogation to rule 10(2)(b) in terms of the powers

delegated to Member States by article 7 of Council Regulation 576/

2013 to authorise the non-commercial movement into their territory

from another Member State of pet animals of the species listed in Part

A of Annex I of the same Council Regulation relating to dogs, cats

and ferrets shall not be applied. The said rule 10(2)(b) shall be

applicable to the dogs, cats and ferrets originating in third countries,

and animals of these species younger than fifteen weeks shall not be

accepted on importation. The same rule shall also apply to all animals

listed in Part A of schedule H that are younger than fifteen weeks and

such animals shall not be allowed to travel.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 26 Reciprocal derogation from the provisions of Articles 6(A)(1)(f), 8(b) and 11(1)(d) of Directive 92/65/ EEC. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

The competent authority may grant another Member State a

derogation from the provisions of Articles 6(A)(1)(f), 8(b) and

11(1)(d) of Directive 92/65/EEC on a reciprocal basis if the recipient

Member State has implemented an alternative control system

providing guarantees equivalent to those laid down in these rules as

regards movements within their territory of the animals, semen, ova

and embryos.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 27 Transitional measures. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

Under the procedure laid down in Article 26 of Directive

92/65/EEC, transitional measures may be adopted for a period of

three years to facilitate the transition to the new arrangements

established by these rules.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 28 Offences and penalties. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

(1) Any person who acts in contravention of these rules and in

contravention of Council Regulations 576/2013 and 577/2013 shall

be guilty of an offence and shall, on conviction, be liable to a fine

(multa) of not more than twenty-three thousand and three hundred

(€23,300) or to imprisonment for not more than six months, or to

both such fine and imprisonment.

(2) Any person who acts in contravention of these rules and in

contravention of Council Regulations 576/2013 and 577/2013, which

infringement relates only to the drawing up of certificates or

documents which do not conform or are not compliant with the

requirements referred to rule 12(1), and with the requirements of

Council Regulations 576/2013 and 577/2013 shall, on conviction, be

liable to a fine (multa) of not more than three hundred euro (€300).

(3) Any person who commits an infringement of these rules

which involves the identification of the animals or the marking of the

semen, ova and embryos which do not conform or are not compliant

with the rules laid down in European Community law and national

legislation on the subject-matter shall, on conviction, be liable to a

fine (multa) of not more than twenty-three thousand and three

hundred (€23,300), or to imprisonment for not more than six months,

or to both such fine and imprisonment.

(4) Any person who commits any infringement of these rules

which involves the lack of checks of the animals or products in

LAID DOWN IN SPECIFIC COMMUNITY ACTS

question as required in rule 12, or Council Regulations 576/2013 and

577/2013, or by other relevant European Community law and national

legislation shall be liable to the same penalties laid down in sub-rule

(1).

(5) Any person who commits any infringement of the

requirements of Commission Regulation 1152/2011, as required by

Article 19 of Council Regulation 576/2013, which involves only the

lack of administration of antip arasitic agents as required by

legislation regulating the movement and importation of dogs shall be

liable on conviction to a fine (multa) of ninety euro (€90), together

with the charges for a period of twenty-four hours in quarantine, the

cost of the medication and any other cost incurred during the

quarantine period for every animal.

Laws of Malta — Subsidiary Legislation 437.98 — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Reg. 29 Applicability of certain provisions of the Act. — ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT Open official source

The provisions of articles 57(2), 58, 60 and 61 of the Act

shall apply to the infringements against these rules which are

punishable in accordance with rule 28.

LAID DOWN IN SPECIFIC COMMUNITY ACTS

ANIMAL HEALTH REQUIREMENTS GOVERNING TRADE AND IMPORTS INTO THE COMMUNITY OF ANIMALS, SEMEN, OVA AND EMBRYOS NOT

Table of Provisions (38)

Statutory Text (38 Articles)

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