Semen of Domestic Animals of the Bovine Species, Rules 2010

L.N. 554 of 2010

VETERINARY SERVICES ACT

(CAP. 437)

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

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 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.

(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.

(4) These rules shall come into force on the 24th

December, 2010.

(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 2009

and those contained under the Animal Health Problems Affecting

Intra-Community Trade in Bovine Animals and Swine Regulations,

2004. 2004 shall continue to apply.

(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 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 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 2009;

“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 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;

“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” 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 2009;

“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 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, 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 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) 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 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 sub-

rule (2) of rule 2 of these rules.

(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 measures conforming to the requirements of 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 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 addition to the application of

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

The Competent Authority ensures that only semen Measures to be

meeting the following general conditions is sent from Malta to adopted

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 sub-

rule (1) of rule 6 hereof;

(b) it shall have been collected from domestic animals

of the bovine 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 7 hereof.

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

part of its territory, contain only animals giving a negative reaction carried

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.

(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) 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 also ensures 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 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 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 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 to these rules.

(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

of these rules has not been observed;

(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 paragraphs (a) or (b) of

sub-rule (3) hereof 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 paragraphs (a) and (b) of sub-

rule (3) hereof and the Member State of collection does not

within 30 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) hereof, 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 of these rules 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) of this rule shall be made subject to the provisions laid

down in sub-article (10) of article 15 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 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) 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 Conditions relating to

imports of semen dispatched from a semen collection or storage storage centres.

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

referred to in rule 9 of these rules, 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 to these

rules;

(ii) relating to the supervision of such centres set

out in Chapter II thereof;

(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 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” or “the Committee” 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 9 of these rules.

(2) Without prejudice to sub-rule (1) of rule 9 hereof

and sub-rule (1) of this rule, 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 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 in accordance with sub-rule (2) hereof 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,

2004. (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 sub-rule (2) of rule 2 of

these rules, on a case-by-case basis, to waive these conditions

where the third country concerned provides similar animal

health guarantees. In such case, animal health conditions at

least equivalent to those in Schedule A to the Animal Health

Problems Affecting Intra-Community Trade in Bovine

Animals and Swine Regulations, 2004 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

of these rules shall mutatis mutandis apply.

(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

13 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 laid down in the

definition “Standing Committee on the Food Chain and Animal

Health or the Committee” provided under sub-rule (2) of rule 2 of

these rules.

The provisions laid down in the Principles Governing Veterinary checks

the Organisation of Veterinary Checks on Products Entering the carried

Territory of Malta from Third Countries Regulations, 2003 shall L.N. 356 of 2003.

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 such 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 hereof 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 of these rules.

If pursuant to rule 13 hereof, 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 in Malta covered by paragraph (a) of sub-rule (1) hereof, and

of the measures which it has taken to control that disease. It shall

also notify them immediately of the disappearance of the disease.

(3) Without prejudice to rules 9, 10 and 11 hereof, 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) hereof 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 sub-rule (2) of rule

2 of these rules, 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) hereof 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) hereof,

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

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

(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

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

(1) Veterinary experts from the Commission may, Veterinary experts.

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

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

be 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 sub-

rules (4) and (5) of rule 3 hereof, 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.

B

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 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 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 to these rules,

- 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

B

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

Schedule II

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 30 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 30 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 30 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, 2004;

(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, 2004 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);

B

(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, 2004;

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

rhinotracheitis/infectious pustular vulvo-vaginitis;

( v ) a v i r u s i s o l a t i o n t e s t ( fl u o r e s c e n t a n t i b o d y t e s t o r

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 30-day isolation period laid down in paragraph (e);

(e) 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) 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 14 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.

B

2. All tests shall 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 movements, both in and out, shall

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 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 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 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, 2004.

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

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 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, 2004.

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

B

Problems Affecting Intra-Community Trade in Bovine Animals and Swine

Regulations, 2004, 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,

2004, 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, 2004, 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

Authority.

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.

Schedule III

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 12 months;

(c) have not been vaccinated against foot-and-mouth disease within 30

days immediately prior to collection;

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

continuous period of at least 30 days immediately prior to collection of the

(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 30 days after collection, 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;

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

commencing 30 days prior to collection and ending 30 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, 2004.

B

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 45 minutes.

3. Semen for intra-Community trade shall

(i) be stored in approved conditions for a minimum period of 30 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.

Schedule IV

ANIMAL HEALTH CERTIFICATE NO

Country of collection

Competent Authority

I. Identification of semen

Number of doses

Date(s) of collection

Identification of donor animal

Breed

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)

Stamp

€2.42