Domestic Animals of the Porcine Species) Rules, 2011.

L.N. 481 of 2011

VETERINARY SERVICES ACT

(CAP. 437)

Animal Health Conditions (Intra-Community Trade and

Imports from Third Countries of Deep-Frozen Semen of

Domestic Animals of the Porcine Species) Rules, 2011.

IN EXERCISE of the powers conferred by articles 9 and

10 of the Veterinary Services Act, the Minister for Resources and

Rural Affairs after consultation with the Minister for Health, the

Elderly and Community Care has made the following rules:-

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

Conditions (Intra-Community Trade and Imports from Third

Countries of Deep-Frozen Semen of Domestic Animals of the

Porcine Species) Rules, 2011.

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

90/429/EEC laying down animal health conditions applicable to

intra-Community trade and imports from third countries of deep-

frozen semen of domestic animals of the porcine species, and shall

apply without prejudice to the provisions adopted pursuant to other

regulations and community rules and other national legislation

regarding domestic animals which may apply in this regard.

(3) These rules are being made for the safeguarding

of the public interest and public safety. Any requirements and

safeguard measures contained therein including those relating to

authorisations are made for overriding reasons relating to public

interest.

(4)

These rules shall come into force on the XXXX,

2011.

(1) Unless stated otherwise in these rules, the

definitions in the Act, those contained under the Veterinary and

Zootechnical Checks applicable in Trade with Member States

in certain Live Animals and Products Regulations, 2003, those

contained under the Animal Health Problems Affecting Intra-

Community Trade in Bovine Animals and Swine Regulations,

2004, those contained under 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, and those contained under the 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 2010, shall apply as necessary.

(2) For the purposes of these rules and unless the

context otherwise requires the following definitions shall apply

“the Act” means the Veterinary Services Act;

“animals of the porcine species” means porcine animals

whose semen is subject to intra-Community trade and imports

from third countries to be produced for use in artificial

insemination;

“approved laboratory” means a laboratory situated

in Malta or a third country designated by the Competent

Authority to carry out the tests laid down in these rules;

“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” has the same meaning as that

provided under 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;

“centre veterinarian” means the veterinarian responsible

for day-to-day compliance in the centre with the requirements

laid down in these rules;

“checks at origin” means veterinary checks which are

carried out on semen of domestic animals of the porcine

species imported from third countries by the Member State

of collection prior to their dispatch to the Member State of

destination for the purpose of intra-Community trade;

“collection” means a quantity of semen taken from a

donor at any time;

“the Commission” means the European Commission;

“the Community” means the European Community as

established by the Treaty on the European Union as amended

by subsequent treaties;

“the Competent Authority” means the department of

veterinary services in Malta as established by article 3 of the

Act;

“consignment” means a quantity of semen covered by a

single certificate;

“country of collection” means the Member State or

third country in which semen is collected and from which it

is sent either directly from the third country of collection, or

indirectly through a Member State to the Member State of

destination;

“the Director” means the Director General of the

Competent Authority or any veterinarian officer nominated

by him;

“donor” means a domestic animal of the porcine species

whose semen is used for artificial insemination;

“final consumer” has the same meaning as that provided

for under 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;

“health certificate” means a certificate properly issued

by the Competent Authority in accordance with Schedule IV

to these rules, as a means of guaranteeing and monitoring

compliance with animal health requirements as regards

animals and products of animal origin subject to trade for the

purpose of these rules;

“importation” means the importation of animals and

their products from a third country into the Community for

the purpose of intra-Community trade;

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

European Union;

“Member State of destination” means such Member

State to which semen is transported either indirectly from the

Member State of collection where the semen collection centre

or establishment of origin is situated, or directly from a semen

collection centre or storage of a third country;

“official veterinarian” has the same meaning as

that provided for under 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;

“pathogenic organisms” means bacteria which causes

infectious diseases;

“the product” means any product of animal origin

subject to trade and trading purposes;

“quarantine” means the voluntary or compulsory

isolation of semen to contain the spread of hazardous or

dangerous diseases;

“semen” means the ejaculate of a domestic animal of the

porcine species, in the unaltered state or prepared or diluted;

“semen collection centre or centre” means an officially

approved and supervised establishment situated in Malta, a

member state or third country, in which semen is produced

for use in artificial insemination;

“Standing Committee on the Food Chain and Animal

Health” or “the Committee” means a Committee made up of

representatives of Member States named committee members,

who assist and consult the Commission by delivering an

Opinion regarding safety measures with respect to animal

health issues to be then formally adopted by the Commission

in accordance with the appropriate procedure. Such

committee procedure covers the entire food supply chain,

ranging from animal health issues on the farm to the product

which arrives to the final consumer, therefore significantly

enhancing its ability to target risks to health wherever they

arise in the production of food;

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

of the European Community;

“trade” means intra-Community trade between Member

States in animals and their products after being imported from

a third country, a business or occupation to make profit or

gain, particularly in wholesale or retail and includes dealings

in a particular business activity;

“the Treaty” means the Treaty on the European Union

establishing the European Community as amended by the

Lisbon Treaty of 2007;

“veterinary checks” means veterinary checks or import

controls carried out on semen imports from third countries

via border inspection posts in accordance with the procedure

laid down in terms of rule 15 of these rules, provided that

import controls between Member States shall be carried out in

conformity to the procedure determined for veterinary checks

in intra-Community trade as provided in sub-rule (2) of rule

3 of 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.

(1) These rules shall apply to

(a) the elimination, as far as possible, of the risk of

animal disease spreading in the case of trade in semen by

means of guarantees provided by third countries that animal

health criteria have been fulfilled;

(b) national animal health provisions governing intra-

Community trade in animals and animal products, in order to

create a harmonized system for intra-Community trade and

imports into the Community of semen of porcine animals;

(c) intra-Community trade in semen, whereby the

Competent Authority ensures that semen has been collected

and processed at approved and supervised semen collection

centres, and that it has been obtained from animals whose

health status is such as to ensure that the risk of spread of

animal diseases is eliminated;

(d) semen which has been collected, processed, stored

and transported in accordance with rules which preserve

its health status and is accompanied during transport to the

Member State of destination by an animal health certificate in

order to ensure that this obligation has been fulfilled;

(e) policies pursued within the Community with

regard to vaccination against certain diseases, authorising

the Competent Authority, in respect of certain diseases, to

impose the requirement of additional protection against those

diseases;

(f) imports of semen into the Community from third

countries whereby a list of third countries should be drawn up

taking into account animal health criteria;

(g) authorisation by the Competent Authority to the

importation of semen only from semen collection centres

which reach certain standards and which are officially

supervised without prejudice to the list mentioned in

paragraph (f) hereof;

(h) specific animal health conditions in respect of

countries on such list which should be laid down according to

circumstances;

(i) the verification of compliance with the standards

mentioned in paragraph (g) hereof, by means of on-spot

checks which may be carried out;

(j) rules and procedures concerning veterinary checks

in intra-Community trade with a view to the completion of

the internal market;

(k) prevent the transmission of certain contagious

diseases, whereby import controls should be carried out

when a consignment of semen arrives and is placed on the

market of the Community and the measures to be taken by

the Competent Authority or other competent authorities after

establishing such controls in the case of internal transit; and

(l) emergency measures which should be sought and

taken by the Competent Authority in the event of outbreaks of

contagious diseases in another Member State or third country.

(2) The Competent Authority shall apply all such

necessary administrative measures conforming to the requirements

of the Standing Committee on the Food Chain and Animal

Health according to the requirements of these rules, to ensure

that there is no breach of these rules and also to reduce the risk

for final consumers and any additional risk to animals and to the

environment.

(3) These measures include the direct confiscation

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

the authorised provider when these are creating a risk to final

consumers and to the environment, and the forfeiture of any

authorisation, licence or permit in terms of article 60 of the Act in

addition to the application of any other administrative penalty in

terms of article 61 of the Act.

The Competent Authority shall ensure that only semen

meeting the following general conditions is intended for trade

(a) it shall have been collected and processed, for

the purpose of artificial insemination, in a semen collection

centre approved from an animal health point of view for the

purposes of intra-Community trade in accordance with sub-

rule (1) of rule 5 of these rules;

(b) it shall have been collected from domestic animals

of the porcine species whose health status complies with

Schedule II to these rules;

(c) it shall have been collected, processed, stored and

transported in accordance with Schedules I and III to these

rules; and

(d) it shall be accompanied, during transport to the

Member State of destination, by an animal health certificate

complying with sub-rule (1) of rule 6 of these rules.

(1) The Competent Authority shall ensure that, with Semen collection

regard to the semen collection centre, the approval provided for

in rule 4 (a) of these rules is granted only where the conditions set

out in Schedule I to these rules are observed and where the semen

collection centre is able to satisfy the other provisions contained in

these rules.

(2) The Competent Authority shall also ensure that the

official veterinarian supervises the observance of these rules and

shall withdraw its approval when one or more of the provisions

contained in these rules are no longer observed.

(3) All semen collection centres shall be registered,

each centre given a veterinary registration number. The

Competent Authority shall draw up and keep up to date a list of

semen collection or storage centres and their veterinary registration

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

public.

(4) The general rules for applying this rule shall

be adopted in accordance with the procedure referred to in the

definition “Standing Committee on the Food Chain and Animal

Health” under sub-rule (2) of rule 2 of these rules, where matters

relating to semen collection centres shall be referred without delay

to the Committee.

(1) The Competent Authority shall ensure that each

consignment of semen is accompanied by an animal health

certificate drawn up in accordance with the specimen in Schedule

IV to these rules by an official veterinarian of the Member State of

collection.

(2) This certificate shall

(a) be drawn up in at least one of the official languages

of the Member State of collection and one of those of the

Member State of destination;

(b) accompany the consignment to its destination in its

original form;

(c) be drawn up on a single sheet of paper; and

(d) be made out to a single consignee.

(3) In addition to measures provided for in regulation 8

of the Veterinary and Zootechnical Checks applicable in Trade with

Member States in certain Live Animals and Products Regulations,

2003 concerning checks carried out at the place of destination of a

consignment or during transport, the Competent Authority may

(a) where the presence of agents responsible for

a disease is established by the Competent Authority, or a

zoonosis or a disease, or any cause is likely to constitute a

serious hazard to animals or humans; or

(b) in the case of products coming from a region

contaminated by an epizootic disease, whereby the Competent

Authority shall order that the animal or consignment of

animals be put in quarantine at the nearest quarantine station

or slaughtered and, or destroyed;

take the necessary measures, including storage in quarantine,

provided this does not affect the viability of the semen, in order to

obtain definite proof in cases where semen is suspected of being

infected or contaminated by pathogenic organisms.

(1) The Competent Authority may authorise importation

of semen only from those third countries which appear on a list

drawn up in accordance with the procedure laid down in the

definition “Standing Committee on the Food Chain and Animal

Health” provided under sub-rule (2) of rule 2 of these rules, and

which list may also be amended in accordance with the same

procedure.

(2) In deciding whether a third country may appear on

the list referred to in sub-rule (1) hereof, particular account shall be

taken of

(a) the state of health of the livestock, other domestic

animals and wildlife in the third country, with particular

reference to exotic animal diseases, and of the environmental

health situation in that country, which might endanger animal

health in Malta;

(b) the regularity and rapidity of the information

supplied by the third country concerning the existence of

contagious animal diseases in its territory, in particular those

diseases mentioned in lists A and B of the International Office

of Epizootic Diseases;

(c) such country’s rules on animal disease prevention

and control;

(d) the structure of the veterinary services in the

country and their powers;

(e) the organization and implementation of measures

to prevent and control contagious animal diseases; and

(f) the guarantees which the third country can give

with regard to compliance with these rules.

(1) The Competent Authority shall only authorise

imports of semen dispatched from a semen collection or storage

centre situated in one of the third countries appearing on the list

referred to in rule 7 of these rules, and for which the competent

authority of the third country concerned is able to give the

guarantees that the following conditions relating to a semen

collection or storage centre are met

(a) it meets the conditions

(i) for approval of semen collection centres or

storage centres set out in Chapter I of Schedule I to these

rules;

(ii) relating to the supervision of such centres set

out in Chapter II of Schedule I to these rules;

(b) it has been officially approved by the competent

authority of the third country for exports to the Community;

(c) it is placed under the supervision of a centre

veterinarian;

(d) it is subject to inspections by an official

veterinarian of the third country at least twice a year.

(2) The list of semen collection or storage centres

which the competent authority of the third country appearing

on the list referred to in rule 7 of these rules has approved, in

accordance with the conditions set out in sub-rule (1) hereof, and

from which semen may be dispatched to the Community, shall be

communicated to the Commission.

(3) The approval of a semen collection or storage

centre shall be immediately suspended or withdrawn by the

competent authority of the third country where it no longer

complies with the conditions set out in sub-rule (1) hereof and the

Commission shall be immediately informed thereof.

(4) Detailed rules for the uniform application of this

rule may be adopted in accordance with the procedure referred to in

the definition “Standing Committee on the Food Chain and Animal

Health” provided under sub-rule (2) of rule 2 of these rules, where

matters relating to such authorisation and approval mentioned in

this rule shall be referred without delay to the Committee.

(1) Semen shall come from animals which, immediately

prior to collection of their semen, have remained for at least six

months in the third country on the list drawn up in accordance with

sub-rule (1) of rule 7 of these rules.

(2) Without prejudice to sub-rule (1) of rule 7 of these

rules and sub-rule (1) hereof, the Competent Authority shall not

authorise the importation of semen from a third country on the list,

unless the semen complies with the animal health requirements

adopted for imports of semen from that country, in accordance with

the procedure laid down in the definition “Standing Committee on

the Food Chain and Animal Health” provided under sub-rule (2) of

rule 2 of these rules.

(3) In adopting the requirements referred to in the

preceding sub-rule, special account shall be given to

(a) the health situation in the area surrounding the

semen collection centre, with particular reference to the

diseases appearing on list A of the International Office of

Epizootic Diseases;

(b) the state of health of the herd in the semen

collection centre, including testing requirements;

(c) the state of health of the donor animal and testing

requirements; and

(d) the testing requirements in relation to semen.

(4) The reference basis for fixing animal health

conditions shall be the standards laid down in rules 4, 5 and 6 of

these rules and their corresponding Schedules. The Competent

Authority may, on a case-by-case basis, decide to waive these

conditions in accordance with the procedure and requirements

of the Standing Committee on Food Chain and Animal Health,

where the third country concerned provides similar animal health

guarantees which are at least equivalent.

(1) The Competent Authority shall authorise the Certification of semen

importation of semen only on submission of an animal health imported

certificate drawn up and signed by an official veterinarian of the

third country of collection.

(2) This certificate shall

(a) be drawn up in at least one of the official languages

of the Member State of destination and one of those of the

Member State where the import control provided for in rule

11 of these rules is carried out;

(b) accompany the semen in the original;

(c) be drawn up on a single sheet of paper; and

(d) be made out to a single consignee.

(3) The certificate shall correspond to a specimen

drawn up in accordance with the procedure provided in the

definition “Standing Committee on the Food Chain and Animal

Health” provided under sub-rule (2) of rule 2 of these rules.

(1) The Competent Authority shall ensure that each

consignment of semen entering the customs territory of the

Community is made subject to control before being released for

free circulation or placed under a customs procedure and shall

prohibit the introduction of the semen into the Community if the

import control made on arrival reveals that

(a) the semen does not come from the territory of a

third country on the list drawn up in accordance with rule 7

(1) of these rules;

(b) the semen does not come from a semen collection

centre on the list provided for in rule 8 (1) of these rules;

(c) the semen comes from the territory of a third

country from which imports are prohibited in accordance with

rule 15 of these rules; and

(d) the animal health certificate which accompanies

the semen is not in conformity with the conditions laid down

in rule 10 of these rules and fixed pursuant thereto.

(2) Sub-rule (1) hereof shall not apply to consignments

of semen which arrive in the Community and are placed under a

customs transit procedure for consignment to a destination situated

outside the Community

Provided that it shall be applicable where customs transit

procedure is waived during transport through the Community.

(3) The Competent Authority may take the necessary

measures, including storage in quarantine provided that this does

not affect the viability of the semen, in order to obtain definite

proof in cases where semen is suspected of being infected or

contaminated by pathogenic organisms.

(4) If the admission of semen has been prohibited on

any of the grounds set out in sub-rules (1) and (2) hereof and the

exporting third country does not authorize the return of the semen

within 30 days in the case of deep-frozen semen, or immediately in

the case of fresh semen, the Competent Authority may order it to

be destroyed.

Each consignment of semen authorised for introduction Authorised

into the Community by the Member State of destination on the semen entering the

basis of the import control referred to in rule 11 (1) of these rules Community.

shall, when sent to another Member State, be accompanied by

the original certificate or an authenticated copy thereof, suitably

endorsed, in either case, by the Competent Authority responsible

for controls carried out in accordance with rule 11 of these rules.

If pursuant to rule 11 (4) of these rules, it is decided that Costs

destruction measures should be taken by the Competent Authority, measures.

any costs incurred shall be chargeable to the consignor or its

agent or representitive, without any compensation thereto by the

Competent Authority.

The rules set out under the Veterinary and Zootechnical

Checks applicable in Trade with Member States in certain Live

Animals and Products Regulations, 2003 shall apply to intra-

Community trade, in particular with regard to checks at origin, the

organisation and the monitoring of the checks to be carried out by

the Member State of destination. The precautionary measures set

out in regulation 11 thereof shall apply to intra-Community trade.

The provisions laid down in the Principles Governing Precautionary

the Organisation of Veterinary Checks on Products Entering the veterinary checks

Territory of Malta from Third Countries Regulations, 2003 shall carried

apply, in particular to the organisation of, and follow-up to the for importation from

checks to be carried out by the Competent Authority, when Malta is third countries.

the Member State of destination, and the safeguard measures to be L.N. 356 of 2003.

applied in accordance with the procedure referred to in regulation

19 thereof, regarding a disease or any other phenomenon or

circumstance liable to present a serious threat to animal or public

health which manifests itself or spreads.

(1) Veterinary experts from the Commission may,

in cooperation with the Competent Authority and competent

authorities of third countries, make on-the-spot checks in so far

as that is indispensable for ensuring uniform application of these

rules.

(2) The country of collection within whose territory a

check is being carried out shall give all necessary assistance to the

experts in carrying out their duties and shall be informed with the

results of the checks.

(3) The country of collection concerned shall take any

measures which may prove necessary to take account of the results

of such check. Failure by the country of collection to take such

measures, may lead the Competent Authority, after the situation

has been examined by the Committee, to have recourse to the

provisions of rule 5 and to sub-rule (2) of rule 6 of these rules.

(4) The general provisions for implementing this rule,

especially as regards the frequency and method of carrying out

the checks referred to in sub-rule (1) hereof shall be laid down in

accordance with the procedure set out in the definition “Standing

Committee on the Food Chain and Animal Health” provided under

sub-rule (2) of rule 2 of these rules.

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

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

measures of sub-rules (2) and (3) of rule 3 of these rules shall

apply to it.

(2) Any right given to the Competent Authority

under these rules to apply all such necessary measures prescribed

in sub-rules (2) and (3) of rule 3 of these rules, shall be given to

the Authority without prejudice to other criminal procedures

which may be taken under the Act or any other law when a person

commits an offence by failing to abide by these rules.

Schedule I

CHAPTER I

Conditions for the approval of semen collection centres

Semen collection centres shall

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

(b) have a least

(i) animal housing including isolation facilities;

(ii) semen collection facilities including a separate room for the cleaning

and disinfection or sterilization of equipment;

(iii) a semen processing room which need not necessarily be on the same

site;

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

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

(d) be so constructed that the animal housing and the semen collecting,

processing and storage facilities can be readily cleaned and disinfected;

(e) have isolation accommodation which shall have no direct communication

with the normal animal accomodation;

(f) be so designed that the animal accommodation is physically separated from

the semen processing room and both are separated from the semen storage

room.

CHAPTER II

Conditions relating to the supervision of semen collection centres

The collection centres shall

(a) be so supervised that they contain only male animals of the species whose

semen is to be collected;

(b) be so supervised that a record, file or computer record is kept of all porcine

animals at the centre, giving details of the breed, date of birth and identification of

each of the animals, and also a record, file or computer record of all checks for

diseases and all vaccinations carried out, giving also information from the

disease/health file of each animal;

(c) be regularly inspected by an official veterinarian, at least twice a year, at

which time checks on the conditions of approval and supervision shall be carried

out;

(d) be so supervised that the entry of unauthorized persons is prevented.

Furthermore, authorized visitors must be required to comply with the conditions

laid down by the centre veterinarian;

(e) employ technically competent staff suitably trained in disinfection procedures

and hygiene techniques relevant to the control of the spread of disease;

(f) be so supervised that

(i) only semen collected at an approved centre is processed and stored in

approved centres, without coming into contact with any other consignment

of semen;

(ii) collection, processing and storage of semen takes place only on the

premises set aside for the purpose and under conditions of the strictest

hygiene;

(iii) all implements which come into contact with the semen or the donor

animal during collection and processing are properly disinfected or

sterilized prior to use;

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

additives or diluents) are obtained from sources which present no animal

health risk or are so treated prior to use that such risk is prevented;

(v) storage flasks and transport flasks are properly disinfected or sterilised

before the beginning of each filling operation;

(vi) the cryogenic agent used has not been previously used for other

products of animal origin;

(vii)

each collection of semen, whether or not it is separated into

individual doses, is clearly marked in such a way that the date of collection

of the semen and the breed and identification of the donor animal, as well

as the name and the registration number of the centre, preceded by the

name of the country of origin, where appropriate, in the form of a code,

can be readily established;

(viii) the characteristics and form of this marking will be established under

the procedure set out in the definition “Standing Committee on the Food

Chain and Animal Health” provided under sub-rule (2) of rule 2 of these

rules.

Schedule II

CHAPTER I

Conditions applying to the admission of animals to approved semen collection

centres

1. All boars admitted to a semen collection centre must

(a) have been subjected to a period of isolation of at least 30 days in

accommodation specifically approved for the purpose by the Competent

Authority and where only boars having at least the same health status are

present;

(b)

prior to their entering the isolation accommodation described in

paragraph (a) have been chosen from herds or holdings

(i) which are officially free of classical swine fever;

(ii) which are free of brucellosis;

(iii) in which no animal vaccinated against foot-and-mouth disease has

been present in the preceding 12 months;

(iv) in which no clinical, serological or virological sign of Aujeszky's

disease has been detected in the preceding 12 months;

(v) which are not covered by any prohibition in accordance with the

requirements of the Animal Health Problems affecting Intra-Community

Trade in Bovine Animals and Swine Regulations, 2004 with regard to

African swine fever, swine vesicular disease, Teschen's disease and foot-

and-mouth disease. The animals may not previously have been kept in

other herds of a lower status;

(c) during the period of isolation specified in paragraph (a), and within the

previous 30 days, have been subjected to the following tests with negative results

(i) a complement fixation test carried out in accordance with the provisions

of Schedule C to the Animal Health Problems affecting Intra-Community

Trade in Bovine Animals and Swine Regulations, 2004 in respect of

brucellosis;

(ii)

a serum neutralization or an ELISA test using all the viral antigens in

the case of non-vaccinated pigs;

(iii) an ELISA test for GI antigens in the case of pigs vaccinated with a

GI deleted vaccine;

(iv) pending the introduction of a Community policy to combat foot-and-

mouth disease, an ELISA test for the presence of foot-and-mouth disease;

(v) an ELISA test or a serum neutralization test for the presence of

classical swine fever. The Competent Authority may give authorization

for the tests referred to in paragraph (c) to be carried out in the isolation

accommodation, provided that the results are known before the beginning

of the 30-day isolation period laid down in paragraph (d);

(d) during the period of isolation of at least 30 days specified in paragraph (a),

have been subjected to the following tests with negative results

(i) a serum agglutination test complying with the procedure laid down in

Schedule C to the Animal Health Problems affecting Intra-Community Trade

in Bovine Animals and Swine Regulations, 2004 and showing a brucella

count lower than 30 IU of agglutination per millilitre and a complement

fixation test showing a brucella count lower than 20 EEC units per millilitre

(20 ICFT units) in the case of animals coming from brucellosis-free herds;

(ii) a serum neutralization or an ELISA test using all the viral antigens in the

case of non-vaccinated pigs;

(iii) an ELISA test for GI antigens in the case of pigs vaccinated with a GI

deleted vaccine;

(iv) until the introduction of a Community policy on combating foot-and-

mouth disease, an ELISA test for the presence of foot-and-mouth disease;

(v) a microscopic agglutination test for the presence of leptospirosis (sero-

vars pomona, grippotyphosa, tarassovi, hardjo, bratislava and ballum serum

viruses), or have been treated for leptospirosis with two injections of

streptomycin at an interval of 14 days (25 mg per kg of live body weight).

Without prejudice to the provisions applicable in cases where foot-and-

mouth disease and swine fever is found, if any of the above tests should

prove positive, the animal must be removed forthwith from the isolation

accommodation. In the case of group isolation, the Competent Authority

must take all necessary measures to allow the remaining animals to be

admitted to the collection centre in accordance with this Schedule.

2. All tests must be carried out in a laboratory approved by the Competent

Authority.

3. Animals may only be admitted to the semen collection centre with the express

permission of the centre veterinarian. All animal movements, both in and out, must

be recorded.

4. No animal admitted to the semen collection centre may show any clinical sign

of disease on the day of admission.

All animals must, without prejudice to

paragraph 5, have come from isolation accommodation as referred to in paragraph

1 (a) which, on the day of consignment, officially fulfils the following conditions

(a) is situated in the centre of an area of 10 kilometres radius in which there

has been no case of foot-and-mouth disease or swine fever for at least 30

days;

(b) has for at least three months been free from foot-and-mouth disease and

brucellosis;

(c) has for at least 30 days been free from Aujeszky's disease and from those

porcine diseases which are compulsorily notifiable in accordance with

Schedule E to the Animal Health Problems affecting Intra-Community Trade

in Bovine Animals and Swine Regulations, 2004.

5. Provided that the conditions laid down in paragraph 4 are satisfied and the

routine tests referred to in Chapter II of this Schedule have been carried out during

the previous 12 months, animals may be transferred from one approved semen

collection centre to another of equal health status without isolation or testing if

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 must have been disinfected before use. If the movement from one

semen collection centre to another takes place between Member States, it must

take place in accordance with the Animal Health Problems affecting Intra-

Community Trade in Bovine Animals and Swine Regulations, 2004.

CHAPTER II

Compulsory routine tests for boars kept at an approved semen collection

centre

1. All boars kept at an approved semen collection centre must be subjected when

leaving the centre to the following tests with negative results

(i)

a serum neutralization or an ELISA test using all the viral antigens in

the case of non-vaccinated pigs;

(ii)

an ELISA test for GI antigens in the case of pigs vaccinated with a GI

deleted vaccine;

(iii) until the introduction of a Community policy on combating foot-and-

mouth disease, an ELISA test for the presence of foot-and-mouth disease;

(iv) a complement fixation test conducted in accordance with Schedule C to

the Animal Health Problems affecting Intra-Community Trade in Bovine

Animals and Swine Regulations, 2004 regarding brucellosis;

(v)

an ELISA test or serum neutralization test for the presence of classical

swine fever.

In addition, boars kept more than 12 months at the collection centre must be

subjected to the tests referred to in points (i) and (iii) not later than 18 months after

their admission.

2. All tests must be carried out in a laboratory approved by the Competent

Authority.

3. Without prejudice to the provisions applicable in cases where foot-and-mouth

disease or swine fever is found, if any of the above tests should prove positive, the

animal must be isolated and the semen collected from it since the last negative test

may not be the subject of intra-Community trade. Semen collected from all other

animals at the centre since the date when the positive test was carried out shall be

held in separate storage and may not be the subject of intra-Community trade until

the health status of the centre has been re-established.

Schedule III

Conditions which semen collected at approved centres must satisfy for the

purposes of intra-Community trade

1. Semen must be obtained from animals which

(a) show no clinical signs of disease on the day the semen is collected;

(b) have not been vaccinated against foot-and-mouth disease;

(c) satisfy the requirements of Chapter I of Schedule II to these rules;

(d) are not allowed to serve naturally;

(e) are kept in semen collection centres which have been free from foot-

and-mouth disease for at least three months prior to dispatching of the

semen, and are situated in the centre of an area of 10 kilometres radius in

which for at least 30 days there has been no case of foot-and-mouth

disease;

(f) are kept in collection centres which must not be situated in a restricted

area designated under the provisions of national legislations or any other

applicable Community law relating to contagious diseases of the porcine

species;

(g) have been kept in semen collection centres which, during the 30-day

period immediately prior to collection, have been free from those porcine

diseases which are compulsorily notifiable in accordance with Schedule

E to the Animal Health Problems affecting Intra-Community Trade in

Bovine Animals and Swine Regulations, 2004 and from Aujeszky's

disease.

2. An effective combination of antibiotics, in particular against leptospires and

mycoplasmas, must be added to the semen after final dilution. This combination

must produce an effect at least equivalent to the following dilutions

not less than

500 IU per ml streptomycin;

500 IU per ml penicillin;

150 mg per ml lincomycin;

300 mg per ml spectinomycin.

Immediately after the addition of the antibiotics the diluted semen must be kept at

a temperature of at least 15°C for a period of not less than 45 minutes.

3. Semen for intra-Community trade must

(i) be stored as laid down in Chapters I and II of Schedule I prior to dispatch;

(ii) be transported to the Member State of destination in flasks which have been

cleaned and disinfected or sterilized before use and which have been sealed prior

to dispatch from the approved storage facilities.

Schedule IV

ANIMAL HEALTH CERTIFICATE

No. ORIGINAL

1. Consignor (name and full address)

2. Member State of collection

3. Consignee (name and full address)

4. Competent authority of country of collection

5. Competent Authority of Malta

6. Place of loading

7. Name and address of semen collection centre

8. Means of transport

9. Place and Member State of destination

10. Registration number of semen collection centre

11. Number and code-mark of semen containers

12. Identification of semen:-

(a) Number of doses

(b) Date(s) of collection

(c) Breed

(d) Identification of donor animal

13. I, the undersigned official veterinarian, certify that

(a) the semen described above was collected, processed and stored under

conditions which comply with the standards laid down in the Animal Health

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

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

2011;

(b) the semen described above was collected from boars

(i) on a collection centre which only contains animals that have not been

vaccinated against Aujeszky's disease and which have reacted negatively to

the serum neutralization test or to the ELISA test for Aujeszky's disease, in

accordance with the provisions of these rules; or

(ii) on a centre in which some or all the boars have been vaccinated against

Aujeszky's disease using a GI deleted vaccine; such boars having been

sero-negative with regard to Aujeszky's disease before vaccination and

subjected three weeks later to a further serological examination which did

not reveal the presence of antibodies induced by the disease virus; and, in

that case, the semen of each batch has been subjected to a virus isolation

test for Aujeszky's disease in the laboratory .................., and gave a

negative reaction; 1

(c) the semen described above was sent to the place of loading in sealed

containers under conditions which comply with the provisions of the Animal

Health Conditions (Intra-Community Trade and Imports from Third

Countries of Deep-Frozen Semen of Domestic Animals of the Porcine

Species) Rules, 2011.

Done at ...........................

Signature

Name and qualification (in block letters).

1 Delete whichever of points (i) or (ii) does not apply.

Delete whichever of points (i) or (ii) does not apply.

Stamp

Notes

(a) A separate certificate must be issued for each consignment of semen

(b) The original of this certificate must accompany the consignment to the place of destination

€2.52