Community Acts Rules, 2015

L.N. 192 of 2015

VETERINARY SERVICES ACT

(CAP. 437)

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, 2015

IN exercise of the powers conferred by article 37(2) of the

Veterinary Services Act, the Minister for Sustainable Development,

the Environment and Climate Change has made the following rules:-

CHAPTER I

General provisions

(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, 2015.

(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.

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

Antilocapridae,

Bovidae,

Camelidae,

Cervidae, Giraffidae, Hippopotamidae and

Tragulidae

Brucella melitensis

Antilocapridae,

Bovidae,

Camelidae,

Cervidae, Giraffidae, Hippopotamidae and

Tragulidae

Brucella ovis

Camelidae,

Tragulidae,

Cervidae,

Giraffidae, Bovidae and Antilocapridae

Brucella suis

Cervidae, Leporidae, Ovibos moschatus,

Suidae and Tayassuidae

Classical swine fever

Suidae and Tayassuidae

Contagious

bovine Bovines (including zebu, buffalo, bison and

pleuropneumonia

yak)

Ebola

Non-human primates

Foot-and-mouth

Artiodactyla and Asian elephants

disease

Infectious

Salmonidae

haematopoeitic

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 Bovidae and Suidae

ruminants

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

Unless otherwise provided in these Rules, the following Interpretation.

definitions shall apply and the definitions, other than those of

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

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;

"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;

"monitoring programme" means a control or monitoring

programme drawn up by the competent authority for the purpose

of keeping of records of animals and products of animal of

origin subject to trade with regard to the outbreak of notifiable

diseases and of diseases referred to in Schedule B;

"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;

"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, monitoring,

organisation of checks and any follow-up thereto with regard to

animals and products of animal origin made by official

veterinarians, and which shall apply in particular, to checks at

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

Member State of destination to guarantee animals’ health and to

safeguard measures to be implemented in this regard, in order to

ensure conformity with animal health requirements governing

trade and which are intended for the protection, direct or

otherwise, of public and, or animal health.

CHAPTER II

Provisions applicable to trade

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

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

restricted for animal health reasons other than those arising from the or

on, trade for

application of these rules or from other local and Community animal

reasons.

legislation, and in particular any safeguard measures taken.

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

-

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 the collection.

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.

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.

(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. 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)

must

(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.

(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 where such

legislation is not available.

CHAPTER I

Conditions applicable to semen collection centres, semen storage

centres, embryo collection teams and embryo production teams

I.

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;

1.2. 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;

1.3. 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

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

(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 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.

II. Conditions for the supervision of semen collection and

storage centres

1. Semen collection centres shall

1.1. 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;

1.2. 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;

(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

2.1. 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;

2.2. 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 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;

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 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 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.

1.6. 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 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;

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.

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

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

(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

(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 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-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 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.

(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 completed

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.

Part 1 - Health Certificate for trade in animals from holdings

(ungulates, birds vaccinated against avian influenza, lagomorphs,

dogs, cats and ferrets) 92/65 EI

Part 2 - Health certificate for trade in bees and bumble

bees 92/65 EII

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

embryos from approved bodies, institutes or centres - 92/65 EIII

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

competent authority shall ensure that ungulates of species other than ungulates.

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 S.L. 437.50

Measures) Rules and the Foot-and-Mouth Disease (Control S.L. 437.81

Measures) Rules as well as regulation 4 of the Animal S.L. 437.48

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 S.L. 437.48

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- S.L.

and-Mouth Disease (Control Measures) Rules, the Foot- S.L. 437.79

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

(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;

(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.

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

The competent authority shall ensure that birds, other than Requirements in

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

subject to trade.

Trade and Imports from Third Countries of Poultry and Hatching S.L. 437.103

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 S.L. 437.103

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 S.L. 437.40

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;

(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.

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

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.

(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 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,

Falconiformesand 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 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.

€6.30

(1) The competent authority shall ensure that Requirements in

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

lagomorphs

following requirements

subject to trade.

(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 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.

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

have been in contact with animals from a holding on which rabies is and foxes.

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

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

trader or person responsible for the load.

(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- S.L. 437.102

Frozen Semen of Domestic Animals of the Porcine Species) Rules

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.

(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.

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

diseases listed in Schedule A or to the diseases listed in Schedule B, species

susceptible to

and trade in semen, ova or embryos of such animals consigned to and diseases.

from bodies, institutes or centres approved in accordance with

Schedule C shall be subject to 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.

(1) The competent authority may establish either Voluntary or

directly or through the breeders, a voluntary or compulsory control or compulsory

control or

monitoring programme for one of the diseases referred to in Schedule monitoring

programme.

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 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).

(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,

out,

(d)

the period over which the surveillance was carried

(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

withdrawn under the procedure laid down in Article 26 of Directive

92/65/EEC.

CHAPTER III

Provisions applicable to imports into the Community

(1) The conditions applicable to imports of animals, Imports of

semen, ova and embryos covered by rules 17, 18, 19 and 20 must be animals,

ova and

at least equivalent to those laid down in Chapter II.

embryos

covered by rules

17, 18, 19 and

(2) With respect to cats, dogs and ferrets, import conditions 20.

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.

(1) The following paragraphs shall apply for the

purposes of the uniform application of rule 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 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 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.

(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 S.L. 439.04

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 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.

The following shall be decided under the procedure laid Applicability of

procedure laid

down in Article 26 of Directive 92/65/EEC

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.

(1) The rules laid down in the Principles Governing the Applicability of

Organisation of Veterinary Checks on Products Entering the Territory the

Governing the

of Malta from Third Countries Regulations shall apply in particular to Organisation

Veterinary

the organisation of, and follow-up to the checks to be carried out by Checks on

the Member States and the safeguard measures to be applied in Products

Entering the

accordance with the procedure referred to in regulation 19 of the said Territory of

Malta from

regulations.

Third Countries

Regulations.

(2) Pending implementation of the decisions provided for in

regulation 8(6) of the Principles Governing the Organisation of S.L. 437.40

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

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.

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.

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.

The competent authority shall allow the entry into Malta of

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.

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.

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.

Under the procedure laid down in Article 26 of Directive Transitional

92/65/EEC, transitional measures may be adopted for a period of measures.

three years to facilitate the transition to the new arrangements

established by these rules.

(1) Any person who acts in contravention of these rules Offences and

and in contravention of Council Regulations 576/2013 and 577/2013 penalties.

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

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 antiparasitic 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.

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.

The Animal Health Requirements governing Trade and

Imports into the Community of Animals, Semen, Ova and Embryos,

not subject to Animal Health Requirements laid down in Specific

Community Acts, Rules, 2009, are hereby revoked.