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

ANIMALS OF THE BOVINE SPECIES

SUBSIDIARY LEGISLATION 437.99

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 *

24th December, 2010 †

LEGAL NOTICE 554 of 2010.

(1) The title of these rules is 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.

(2) The scope of these rules is to transpose Directive 88/407/

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 bovine 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 at 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 animals of the species whose

semen is to be collected. Other domestic animals which are strictly

necessary for the normal operation of the collection centre may

nonetheless also be admitted, provided that they present no risk of

infection to those species whose semen is to be collected and they fulfill

the conditions laid down by the centre veterinarian;

(b) be so supervised that a record is kept of all bovine animals at the centre,

giving details of the breed, date of birth and identification of each of the

animals, and also a 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 standing checks on the conditions of approval and

supervision shall be carried out;

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

Furthermore, authorised visitors shall 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

ANIMALS OF THE BOVINE SPECIES

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. However, semen not collected in an

approved centre may be processed in approved collection centres

provided that

- such semen is produced from bovine animals which fulfill

the conditions laid down in Chapter I, 1(d)(i), (ii), (iii) and

(v) of Schedule II,

- processing is carried out with separate equipment or at a

different time from semen intended for intra-Community

trade, the equipment in the latter case being cleaned and

sterilized after use,

- such semen may not be the subject of intra-Community trade

and cannot at any time come into contact with or be stored

with semen intended for intra-Community trade,

- such semen is identifiable by a marking different from that

provided for in point (vii);

(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 a diluent - 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

sterilized before the commencement of each filling operation;

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

products of animal origin;

(vii) each individual dose of semen 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 of the

centre, possibly in code, can be readily established; the

characteristics and form of this marking will be established in

accordance with the procedure laid down in the definition

"Standing Committee on the Food Chain and Animal Health" or

"the Committee" provided under rule 2(2).

ANIMALS OF THE BOVINE SPECIES

(1) Unless stated otherwise in these rules, the definitions

in the Act, 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 Problems Affecting Intra-

Community Trade in Bovine Animals and Swine Regulations shall

continue to apply.

(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 bovine species" means bovine animals whose

semen is subject to intra-Community trade and imports from third

countries to be produced for use in artificial insemination;

"Appeals Board" shall have the same meaning as that provided

under the Services (Internal Market) Act, designated in accordance

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

†see rule 1(4) as originally promulgated.

ANIMALS OF THE BOVINE SPECIES

with article 12(f) thereof;

"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" shall have 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;

"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 of the European Union;

"the competent authority" means the Department responsible for

veterinary services in Malta as established by 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 or indirectly to another Member State;

"the Director" means the Director responsible for veterinary

services or any veterinarian officer nominated by him;

"donor" means a domestic animal of the bovine species whose

semen is used for artificial insemination;

"final consumer" shall have 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

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;

"M embe r Sta te" m ea ns a State which i s a member t o the

European Union;

"Member State of destination" means such Member State to

ANIMALS OF THE BOVINE SPECIES

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" shall have 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;

"the product" means any product of animal origin subject to trade

and trading purposes;

"semen" means the prepared or diluted ejaculate of a domestic

animal of the bovine species;

"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 Member States’

representatives 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, for the purpose of these rules, trade between

Member States or between a Member State and a third country in

animals and their products, 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 as established by the European

Union;

"veterinary checks" means for the purpose of these rules,

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 13, 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 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 MOVEMENT OF ANIMALS

INTO APPROVED SEMEN COLLECTION CENTRES

1. All bovine animals admitted to a semen collection centre shall

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

accommodation specifically approved for such purpose by the

competent authority, and where only other cloven-hoofed animals

having at least the same health status are present;

(b) prior to their stay in the isolation accommodation described in

paragraph (a) have belonged to herds

(i) which are officially tuberculosis free;

(ii) which are officially brucellosis free. The animals may not

previously have been kept in other herds of a lower status;

(c) have come from a herd free of enzootic bovine leukosis or have been

produced by a cow which has been subjected to a serological test for

enzootic bovine leukosis with a negative result, not more than thirty

days before the animal’s admission to the centre. If this requirement

cannot be fulfilled, the semen may not be the subject of trade until the

donor has reached the age of two years and has been tested in

accordance with Chapter II, 1(iii) with a negative result;

(d) before 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)

an intradermal tuberculin test carried out in accordance with the

procedure laid down in Schedule B to the Animal Health

Problems Affecting Intra-Community Trade in Bovine Animals

and Swine Regulations;

(ii) a serum agglutination test carried out in accordance 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 in the case of brucellosis

free herds a complement fixation test showing a brucella count

lower than 20 EEC units per millilitre (20 ICFT units);

(iii) a serological test for enzootic bovine leukosis carried out in

accordance with the procedure laid down in Schedule D to the

Animal Health Problems Affecting Intra-Community Trade in

Bovine Animals and Swine Regulations;

(iv) a serum neutralization test or an Elisa test for infectious bovine

rhinotracheitis/infectious pustular vulvo-vaginitis;

(v) a virus isolation test (fluorescent antibody test or

immunoperoxidase test) for bovine viral diarrhoea. In the case of

an animal less than six months of age the test shall be deferred

until that age is reached. The competent authority may give

authorisation for the tests referred to in paragraph (d) to be

carried out in the isolation accommodation, provided that the

results are known before the commencement of the thirty-day

ANIMALS OF THE BOVINE SPECIES

isolation period laid down in paragraph (e);

(e)

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) either an immunofluorescent antibody test or a culture test for

campylobacter foetus infection on a sample of preputial material

or artificial vaginal washings; in the case of female animals a

vaginal mucus agglutination test shall be carried out;

(iii) a microscopic examination and culture test for trichomonas foetus

on a sample of vaginal washings or preputial washings; in the

case of female animals a vaginal mucus agglutination test shall be

carried out;

(iv) a serum neutralization test or an Elisa test for infectious bovine

rhinotracheitis/infectious pustular vulvo-vaginitis; and have

treatment against leptospirosis comprising two injections of

streptomycin at an interval of fourteen days (25 mg per kilogram

of live body weight). If any of the above tests should prove

positive, the animal shall be removed forthwith from the isolation

accommodation. In the case of group isolation, the Competent

Authority shall take all necessary measures to re-establish the

eligibility of the remaining animals for entry into the collection

centre in accordance with this Schedule.

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

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

express permission of the centre veterinarian. All movements, both in and out, shall

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

sign of disease on the day of admission. All animals shall, 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 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 those bovine diseases which

are compulsorily notifiable in accordance with Schedule E (II) 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 have been carried out during the previous

ANIMALS OF THE BOVINE SPECIES

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 shall not come into direct or indirect contact with

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

have been disinfected before use. If the movement from one semen collection centre

to another takes place between Member States it shall take place in accordance with

the Animal Health Problems Affecting Intra-Community Trade in Bovine Animals

and Swine Regulations.

CHAPTER II

ROUTINE TESTS AND TREATMENT WHICH SHALL BE APPLIED TO ALL

BOVINE ANIMALS IN AN APPROVED SEMEN COLLECTION CENTRE

1. All bovine animals kept at an approved semen collection centre shall be

subjected at least once a year to the following tests and treatment

(i)

an intradermal tuberculin test for tuberculosis, carried out in accordance

with the procedure laid down in Schedule B to the Animal Health

Problems Affecting Intra-Community Trade in Bovine Animals and

Swine Regulations, with a negative result;

(ii)

a serum agglutination test for brucellosis, carried out in accordance with

the procedure laid down in Schedule C to the Animal Health Problems

Affecting Intra-Community Trade in Bovine Animals and Swine

Regulations, giving a count lower than 30 IU of agglutination per

millilitre;

(iii)

a serological test for enzootic bovine leukosis, carried out in accordance

with the procedure laid down in Schedule D to the Animal Health

Problems Affecting Intra-Community Trade in Bovine Animals and

Swine Regulations, with a negative result;

(iv)

for infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis,

a serum neutralization test or an Elisa test with a negative result;

(v)

either an immunofluorescent antibody test or a culture test for

campylobacter foetus infection on a sample of preputial material or

artificial vaginal washings; in the case of female animals a vaginal

mucus agglutination test shall be carried out.

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

3. If any of the above tests should prove positive, the animal shall 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.

ANIMALS OF THE BOVINE SPECIES

(1)

These rules shall apply to

ANIMALS OF THE BOVINE SPECIES

(a) 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 bovine animals;

(b) 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;

(c) 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 country or member state of destination by an

animal health certificate in order to ensure that this

obligation has been fulfilled;

(d) 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;

(e) 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;

(f)

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 (e);

(g) specific animal health conditions in respect of

countries on such list which should be laid down

according to circumstances;

(h) the verification of compliance with the standards

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

checks which may be carried out;

(i)

the procedure which should be provided for the

purpose of settling of disputes which may arise

between Member States as to whether approval of a

collection centre is justified; and

(j)

the prevention of 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 Member States after such controls have

been defined, in case of internal transit.

(2) The competent authority shall take emergency measures in

the event of an outbreak of a contagious disease in another Member

State or in a third country, which in case of internal transit such

ANIMALS OF THE BOVINE SPECIES

measures which shall be defined, and shall assess the dangers

associated with such diseases and the protective measures required

in this regard, in conformity with the procedure mentioned in the

definition "Standing Committee on the Food Chain and Animal

Health" or "the Committee" defined under rule 2(2).

(3) The competent authority may refuse a consignment of

semen where it has been established that it does not comply with

the provisions of these rules, and return such semen, if this is not

contrary to considerations of animal health, and if the consignor or

his representative so requests, it shall give a reasoned opinion to

such consignor or his representative for such prohibition or

restriction and the consignor or his representative shall be allowed

to obtain the opinion of an expert.

(4) The Director shall apply all such necessary administrative

m e a s u r e s c o n f o r m i n g t o t h e r e q u i r e m e n t s o f t h e St a n d i n g

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.

(5) These measures shall 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 addition to the application of any

other administrative penalty in terms of article 61 of the Act.

CONDITIONS WHICH SEMEN COLLECTED AT APPROVED CENTRES SHALL

SATISFY FOR THE PURPOSES OF INTRA-COMMUNITY TRADE

1. Semen shall be obtained from animals which

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

(b)

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

(ii) come from a centre where all the animals have been fully

protected against types A, O and C;

- and are thus either animals which, before entering the centre,

were not previously vaccinated against foot-and-mouth

disease and shall, therefore, have received two doses of

inactivated virus vaccine approved and controlled by the

competent authority of the exporting Member State at an

interval of not less than six weeks and not more than eight

months,

- or animals which, before entering the centre, were vaccinated

on at least three occasions at intervals of not more than one

year. When vaccination is practised, all animals shall receive

repeat vaccinations at intervals of not more than twelve

months;

(c) have not been vaccinated against foot-and-mouth disease within thirty

days immediately prior to collection;

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

period of at least thirty days immediately prior to collection of the

semen;

(e) are not allowed to serve naturally;

(f)

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

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

semen and thirty days after collection, and are situated in the centre of

an area of ten kilometres radius in which for at least thirty days there

has been no case of foot-and-mouth disease;

(g) have been kept in semen collection centres which, during the period

commencing thirty days prior to collection and ending thirty days after

collection of the semen, have been free from those bovine diseases

which are compulsorily notifiable in accordance with Schedule E (II) to

the Animal Health Problems Affecting Intra-Community Trade in

Bovine Animals and Swine Regulations.

2. Antibiotics as listed below shall be added to produce these concentrations in

the final diluted semen

not less than: 500 IU per ml streptomycin,

500 IU per ml penicillin,

150 mg per ml lincomycin,

300 mg per ml spectinomycin. An alternative combination of antibiotics with

an equivalent effect against campylobacters, leptospires and mycoplasmas

may be used. Immediately after their addition the diluted semen shall be kept

at a temperature of at least 5°C for a period of not less than forty-five

ANIMALS OF THE BOVINE SPECIES

minutes.

3. Semen for intra-Community trade shall

(i)

be stored in approved conditions for a minimum period of thirty days

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 ensures that only semen meeting

the following general conditions is sent from Malta to another

Member State

(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 6(1);

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

the bovine species whose health status complies with

Schedule II;

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

transported in accordance with Schedules I and III;

and

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

Member State of destination, by an animal health

certificate complying with rule 7(1).

ANIMAL HEALTH CERTIFICATE NO

Country of collection

Competent Authority

I. Identification of semen

Number of doses

Date(s) of collection

Identification of donor animal

Date of birth

II. Origin of semen

Address of semen collection centre(s)

Approval number of semen collection centre(s)

III. Destination of semen

The semen will be sent from: (name of consignor)

The semen will be sent from: (place of loading)

The semen will be sent to: (country and place of destination)

The semen will be sent by: (means of transport)

Name and address of consignee

IV. I, the undersigned official veterinarian, certify that

1. the semen described above was collected, processed and stored under

conditions which comply with the standards laid down in these rules;

2. the semen described above was sent to the place of loading in a sealed

container under conditions which comply with these rules.

Done at ............................................ on ........................................... .

Signature

Name and qualification (in block letters)

(1) In the case where all collection centres in Malta or part

of its territory, contain only animals giving a negative reaction to

the serum neutralization test or the Elisa test for infectious bovine

rhino-tracheitis or infectious pustular vulvo-vaginitis or showing a

positive result after vaccination in accordance with these rules, the

Competent Authority may refuse admission of semen from centres

which do not have such status.

ANIMALS OF THE BOVINE SPECIES

(2) Without prejudice to other Community laws and

regulations, a Member State of destination which do not practise

vaccination against foot-and-mouth disease may not oppose the

admission of semen from animals vaccinated in accordance with

these rules. In such event, up to 10% of the semen from each

collection intended for trade, may be subjected to a virus isolation

test for foot-and-mouth in a laboratory in the Member State of

destination or in a laboratory specified by such Member State. If

the result is positive, admission of the semen may be refused.

(1) The competent authority ensures 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 also ensures 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 approved semen collection or storage 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) 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" or "the Committee" under rule 2(2), where matters relating

to semen collection centres shall be referred without delay to the

Committee.

(1) The competent authority shall make the admission of

semen from other Member States subject to an animal health

certificate drawn up by the official veterinarian in such Member

State in accordance with Schedule IV.

(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) The competent authority, where Malta is the Member State

of destination may

(a) prohibit the admission of consignments if a

documentary check or health certificate reveals that

rule 4 has not been observed;

ANIMALS OF THE BOVINE SPECIES

(b) take the necessary measures, including storage in

quarantine, in order to obtain definite proof in cases

where semen is suspected of being infected or

contaminated by pathogenic organisms.

(4) Decisions taken under sub-rule (3)(a) or (b) shall, at the

request of the consignor or his representative, authorise the return

of the semen, provided this is not contrary to considerations of

animal health.

(5) If the admission of semen has been prohibited on any of the

grounds set out in sub-rule (3)(a) and (b) and the Member State of

collection does not within thirty days authorise the return of the

semen, the competent authority may order it to be destroyed.

(6) Except in the case of the granting of an authorisation, a

decision taken by the competent authority under sub-rules (3) and

(5), including refusal or destruction of semen, shall be

communicated to the consignor or his representative, and shall be

fully reasoned and be open to challenge before the Appeals Board.

(1) The reasoned decisions taken pursuant to rule 7 shall,

on request, be communicated to the consignor or his representative

in writing, with a reference to what rights of appeal are provided

for in the current national legislation, and of the form and time

limits in which proceedings shall be initiated by the Member State

of collection against whom such decisions were taken. The

decisions shall also be communicated to the competent veterinary

authority of the Member State of collection.

(2) The competent authority shall grant to consignors in respect

of whose consignments of semen such measures as are provided for

in rule 7(3) have been taken, the right to obtain, before other

measures are taken by the competent authority, the opinion of a

veterinary expert to determine whether rule 7(3) has been complied

with. The veterinary expert shall be a national of a third party

Member State, other than Malta or the Member State of collection.

(3) The rights of appeal and the set-up of proceedings initiated

by the Member State of collection as referred to in sub-rule (1)

shall be made subject to the provisions laid down article 15(10) of

the Arbitration Act.

(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 or the

Committee" 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,

ANIMALS OF THE BOVINE SPECIES

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) that 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 9, and for which the competent authority of the third

country concerned is able to give the guarantees that the following

conditions 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 9 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

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definition "Standing Committee on the Food Chain and Animal

Health" or "the Committee" 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 9(1).

(2) Without prejudice to sub-rule (1) and rule 9(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" or "the Committee" 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 in

accordance with sub-rule (2) for bovine tuberculosis and

brucellosis shall be the standards laid down in Schedule A to the

Animal Health Problems Affecting Intra- Community Trade in

Bovine Animals and Swine Regulations.

(5) The competent authority may decide, in accordance with

the procedure laid down in the definition "Standing Committee on

the Food Chain and Animal Health or the Committee" provided

under rule 2(2), on a case-by-case basis, to waive these conditions

where the third country concerned provides similar animal health

guarant ees. In such case, ani mal h ealth con di tio ns at least

equivalent to those in Schedule A to the Animal Health Problems

Affecting Intra-Community Trade in Bovine Animals and Swine

Regulations shall be laid down in accordance with the same

procedure in order to permit the entry of such animals into semen

collection centres. Rule 4 shall mutatis mutandis apply.

(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

ANIMALS OF THE BOVINE SPECIES

(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 13 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

a c c o r d a n c e wi t h th e p r o c e d u r e l a id d o w n i n t h e d e f i n i t i o n

"Standing Committee on the Food Chain and Animal Health or the

Committee" provided under rule 2(2).

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 of the

said regulations, 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.

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 13 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 13.

If, pursuant to rule 13, 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.

(1) The competent authority may take the following

measures if there is a danger of an animal disease spreading as a

result of the introduction of semen in Malta from another Member

State

(a) in the event of an outbreak of an epizootic disease in

the other Member State, it may temporarily prohibit or

restrict the introduction of semen from the areas of

that Member State where the disease has occurred;

(b) if an epizootic disease becomes widespread, or if there

is an outbreak of a further contagious animal disease

of a serious nature, it may temporarily prohibit or

restrict the introduction of semen from the whole of

the territory of that Member State.

(2) The competent authority shall immediately inform the other

Member States and the Commission of the outbreak of any disease

ANIMALS OF THE BOVINE SPECIES

in Malta covered by sub-rule (1)(a), and of the measures which it

ha s t a k e n t o c o nt r o l th a t d i s e a s e . I t s ha l l a ls o n o t if y t h e m

immediately of the disappearance of the disease.

(3) Without prejudice to rules 9, 10 and 11, if in a third country

a contagious animal disease which can be carried by semen and is

liable to endanger the health of the livestock in Malta breaks out or

spreads or if any other reason connected with animal health so

justifies, the competent authority shall prohibit the importation of

that semen, whether imported indirectly through another Member

State, or directly from a third country as a whole or from only part

thereof.

(4) Measures taken by the competent authority on the basis of

sub-rules (1) and (2) and the repeal of such measures shall be

communicated immediately to the other Member States and the

Commission together with the reasons for taking such measures.

(5) In accordance with the procedure laid down in the

definition "Standing Committee on the Food Chain and Animal

Health" or "the Committee" provided under rule 2(2), it may be

decided that those measures shall be amended, in particular in order

to coordinate them with measures adopted by the other Member

States, or that they shall be repealed.

(6) If the situation envisaged in sub-rules (1) and (2) arises,

and if it is necessary that other Member States also apply the

measures taken under such sub-rules as amended where necessary

in accordance with sub-rules (4) and (5), appropriate steps shall be

taken in accordance with the procedure laid down in the definition

"Standing Committee on the Food Chain and Animal Health" or

"the Committee" provided under rule 2(2).

(7) Resumption of importation from the third country

concerned shall be authorised in accordance with the procedure laid

down in the definition "Standing Committee on the Food Chain and

Animal Health" or "the Committee" provided under rule 2(2).

(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. The country of collection concerned

shall take any measures which may prove necessary to take account

of the results of the investigation.

(3) 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 in the definition "Standing Committee

on the Food Chain and Animal Health" or "the Committee"

provided under rule 2(2).

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

ANIMALS OF THE BOVINE SPECIES

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

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

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

rules to apply all such necessary measures prescribed in rule 3(4)

and (5), 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.

ANIMALS OF THE BOVINE SPECIES