ANIMAL HEALTH CONDITIONS (INTRA-COMMUNITY TRADE AND IMPORTS FROM THIRD COUNTRIES OF DEEP-FROZEN

SEMEN OF DOMESTIC ANIMALS OF THE PORCINE SPECIES)

SUBSIDIARY LEGISLATION 437.102

ANIMAL HEALTH CONDITIONS

(INTRA-COMMUNITY TRADE AND IMPORTS

FROM THIRD COUNTRIES OF DEEP-FROZEN

SEMEN OF DOMESTIC ANIMALS OF

THE PORCINE SPECIES) RULES *

16th December, 2011 †

LEGAL NOTICE 481 of 2011.

(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.

(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.

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

SEMEN OF DOMESTIC ANIMALS OF THE PORCINE SPECIES)

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 rule 2(2).

(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, those contained under the

Animal Health Problems Affecting Intra- Community Trade in

Bovine Animals and Swine Regulations, 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 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 shall apply as necessary.

(2) For the purpose 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

*These rules have been repealed by Legal Notice 77 of 2025.

†see rule 1(4) as originally promulgated.

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;

"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;

"health certificate" means a certificate properly issued by the

SEMEN OF DOMESTIC ANIMALS OF THE PORCINE SPECIES)

competent authority in accordance with Schedule IV, 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 St ate" m eans a St ate which is a m ember 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;

"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 Com mission 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

c o u n t r y, a b u s i n e s s o r o c c u p a t i o n t o m a k e p r o f i t o r g a i n ,

particularly in wholesale or retail and includes dealings in a

particular business activity;

" t h e Tr e a t y " m e a n s t h e Tr e a t y o n t h e E u r o p e a n U n i o n

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, provided that import controls between Member

St a t e s s h a l l b e c a r r i e d o u t i n c o n f o r m i t y t o t h e p r o c e d u r e

determined for veterinary checks in intra-Community trade as

provided in rule 3(2) 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.

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 thirty 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 twelve months;

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

disease has been detected in the preceding twelve 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,

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 thirty 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, 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 thirty-day isolation

period laid down in paragraph (d);

(d) during the period of isolation of at least thirty 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, 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

(serovars pomona, grippotyphosa, tarassovi, hardjo, bratislava

and ballum serum viruses), or have been treated for leptospirosis

with two injections of streptomycin at an interval of fourteen 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

SEMEN OF DOMESTIC ANIMALS OF THE PORCINE SPECIES)

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

thirty days;

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

brucellosis;

(c) has for at least thirty 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.

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 twelve 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.

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, regarding brucellosis;

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

swine fever.

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

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

after their admission.

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

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.

(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);

SEMEN OF DOMESTIC ANIMALS OF THE PORCINE SPECIES)

(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), 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

auth orised provi der wh en t hese are c reating 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.

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;

(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 thirty 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 thirty-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, 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;

SEMEN OF DOMESTIC ANIMALS OF THE PORCINE SPECIES)

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 forty-five 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.

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 rule 5(1);

(b) it shall have been collected from domestic animals of

the porcine species whose health status complies with

Schedule II;

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

transported in accordance with Schedules I and II; and

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

Member State of destination, by an animal health

certificate complying with rule 6(1).

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;

(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; *

(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.

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

Name and qualification (in block letters).

(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

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

(1) The competent authority shall ensure that, with regard

to the semen collection centre, the approval provided for in rule

4(a) is granted only where the conditions set out in Schedule I 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

w it h d r a w i t s ap p r ov a l w he n o n e o r m o r e o f t h e p r ov i s i o ns

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

rule 2(2), where matters relating to semen collection centres shall

be referred without delay to the Committee.

(1) The competent authority shall ensure that each

consignm ent of semen is accom panied by an anim al health

certificate drawn up in accordance with the specimen in Schedule

IV 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,

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

SEMEN OF DOMESTIC ANIMALS OF THE PORCINE SPECIES)

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 rule 2(2), 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), 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, 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;

(ii) relating to the supervision of such centres set out

in Chapter II of Schedule I;

(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 has approved, in accordance with the

conditions set out in sub-rule (1), 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) 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 rule 2(2), 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

rule 7(1).

(2) Without prejudice to sub-rule (1) and rule 7(1), 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 rule 2(2).

(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 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

SEMEN OF DOMESTIC ANIMALS OF THE PORCINE SPECIES)

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

importation of semen only on submission of an animal health

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 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

rule 2(2).

(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);

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

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

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

from which imports are prohibited in accordance with

rule 15; and

(d) the animal health certificate which accompanies the

semen is not in conformity with the conditions laid

down in rule 10 and fixed pursuant thereto.

(2) Sub-rule (1) 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) and the exporting third

country does not authorize the return of the semen within thirty

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

into the Community by the Member State of destination on the

basis of the import control referred to in rule 11(1) shall, when sent

t o a n o t h e r M e m b e r St a t e , b e a c c o m p a n i e d b y t h e o r i g i n a l

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.

If pursuant to rule 11(4), it is decided that destruction

measures should be taken by the Competent Authority, 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 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 the

Organisation of Veterinary Checks on Products Entering the

Territory of Malta from Third Countries Regulations shall apply, in

particular to the organisation of, and follow-up to the checks to be

carried out by the competent authority, when Malta is the Member

State of destination, and the safeguard measures to be 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

SEMEN OF DOMESTIC ANIMALS OF THE PORCINE SPECIES)

provisions of rule 5 and to rule 6(2).

(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) 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 rule 2(2).

(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 rule 3(2) and (3) shall apply to it.

(2) Any right given to the competent authority under these

rules to apply all such necessary measures prescribed in rule 3(2)

and (3) shall be given to the competent 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.