ANIMAL HEALTH CONDITIONS GOVERNING INTRA-COMMUNITY TRADE AND IMPORTATION FROM THIRD COUNTRIES OF EMBRYOS OF

EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES

SUBSIDIARY LEGISLATION 437.100

ANIMAL HEALTH CONDITIONS GOVERNING

INTRA-COMMUNITY TRADE AND IMPORTATION

FROM THIRD COUNTRIES OF EMBRYOS OF

DOMESTIC ANIMALS OF THE BOVINE SPECIES

RULES RULES *

24th December, 2010 †

LEGAL NOTICE 555 of 2010.

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

Governing Intra-Community Trade and Importation from Third

Countries of Embryos of Domestic Animals of the Bovine Species

Rules.

(2) The scope of these rules is to transpose Directive 89/556/

EEC laying down animal health conditions governing intra-

Community trade and importation from third countries of embryos

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 or pet 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 an embryo collection team

In order to be given approval each embryo collection team shall fulfill the

following requirements

(a) the collection, processing and storage of embryos shall be carried out

either by a team veterinarian or under his responsibility by one or more

technicians who are competent and trained by the team veterinarian in

methods and techniques of hygiene;

(b) it shall be placed under the general supervision and authority of the

official veterinarian;

(c) it shall have at its disposal permanent or mobile laboratory facilities

where embryos can be examined, processed and packed, consisting of at

least a work surface, a microscope and cryogenic equipment;

(d) in the case of a permanently sited laboratory, it shall have at its

disposal

(i)

a room where embryos can be manipulated which is adjacent to

but physically separate from the area used to handle the donor

animals during collection,

(ii) a room or area equipped for cleansing and sterilizing instruments

and equipment used in embryo collection and manipulation;

(e) it shall have at its disposal, in the case of a mobile laboratory, a

specially equipped part of the vehicle consisting of two separate

sections

(i)

one for the examination and manipulation of embryos which shall

be a clean section; and

(ii) the other for accommodating equipment and materials used in

contact with the donor animals.

A mobile laboratory shall always have contact with a permanently sited

laboratory to ensure the sterilization of its equipment and the provision of fluids and

other products necessary for the collection and manipulation of embryos.

CHAPTER II

Conditions relating to the collection, processing, storage and transport of embryos

by the approved embryo collection team

1. Collection and processing

(a) Embryos shall be collected and processed by an approved collection

team, without coming into contact with any other consignment of

embryos not meeting the requirements of these rules.

(b) Embryos shall be collected in a place which is isolated from other parts

of the premises or holding and which shall be in good repair and easy to

cleanse and disinfect.

(c) Embryos shall be processed (examined, washed, treated and placed in

identified and sterile containers) in either a permanent laboratory

facility or a mobile laboratory facility, which is not situated in a zone

subject to prohibition or quarantine measures.

EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES

(d) All implements which come into contact with the embryos or the donor

animal during collection and processing shall be disposable or shall be

properly disinfected or sterilized prior to use.

(e) Products of animal origin used during collection of the embryos and in

the transport medium shall be obtained from sources which present no

animal health risk or are to be so treated prior to use so that such risk is

prevented.

(f)

Storage flasks and transport flasks shall be properly disinfected or

sterilized before the commencement of each filling operation.

(g) The cryogenic agent used shall not have been previously used for other

products of animal origin.

(h) Each embryo container and the containers in which they are stored and

transported shall be clearly code-marked in such a way that the date of

collection of the embryos and the breed and identification of the donor

sire and donor dam, as well as the registration number of the team can

be readily established. The characteristics and form of this code-

marking shall be established in accordance with the procedure laid

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

Animal Health or the Committee" in rule 2(2).

(i)

Each embryo shall be washed at least ten times in a special fluid for

embryos which shall be changed each time and which, unless decided

otherwise under paragraph (m), shall contain trypsin, in accordance

with internationally recognized procedures. Each wash shall be a 100-

fold dilution of the previous wash and a sterile micropipette shall be

used to transfer the embryo on each occasion.

(j)

After the last wash each embryo shall be subjected to microscopic

examination over its entire surface to determine that the zona pellucida

is intact and is free from any adherent material.

(k) Each consignment of embryos that has successfully undergone the

examination provided for in paragraph (j) shall be placed in a sterile

container marked in accordance with paragraph (h) and which shall be

sealed immediately.

(l)

Each embryo shall, where appropriate, be frozen as soon as possible and

stored in a place which is under the control of the team veterinarian and

which is subject to regular inspection by an official veterinarian.

(m) In accordance with the procedure laid down in the definition "Standing

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

in rule 2(2) concerning authorised flushing and washing fluids, washing

techniques and, where necessary, enzymatic treatments together with

authorized transportation media. Pending the adoption of a protocol on

enzymatic treatments, the national rules on the use of trypsin shall

continue to apply, in compliance with the general provisions of the

Treaty.

(n) Each collection team shall submit routine samples of flushing fluids,

washing fluids, disintegrated embryos, non-fertilized ova etc., resulting

from its activities for official examination for bacterial and viral

contamination. The procedure for collecting of samples, conducting

such examinations, together with the standards to be achieved shall be

decided in accordance with the procedure laid down in in the definition

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

Committee" in rule 2(2). If the standards laid down are not achieved the

competent authority which granted the official approval to the team

shall withdraw that approval.

(o) Each collection team shall keep a record of its activities in respect of

embryo collection during the twelve months before and twelve months

after storage including

(i) the breed, age and identification of the donor animals concerned,

(ii) the place of collection, processing and storage of embryos

collected by the team,

(iii) the identification of the embryos together with details of their

destination if known.

2. Storage

Each embryo collection team shall ensure that the embryos are stored at suitable

temperatures in premises approved for the purpose by the competent authority. In

order to be approved these premises shall

(i)

comprise at least one lockable room intended exclusively for embryo

storage;

(ii)

be easy to cleanse and disinfect;

(iii)

have permanent records of all incoming and outgoing movements of

embryos. The final destination of the embryos in particular shall be

specified in such records;

(iv)

be subject to inspection by the official veterinarian.

The competent authority may authorize the storage of semen that fulfils the

requirements of the Animal Health Conditions Applicable to Intra-Community Trade

and Imports from Third Countries of Deep-Frozen Semen of Domestic Animals of

the Bovine Species, Rules 2010 in the approved storage premises.

3. Transport

Embryos for trade shall be transported in satisfactory hygienic conditions in

sealed containers from the approved storage premises until their arrival at their

destination. The containers shall be marked in such a way that the number coincides

with the number on the animal health certificate.

(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

embryos are subject to intra-Community trade and imports from

third countries, after being removed from a female donor for the

purpose of being transmitted, transplanted or injected to the female

recipient;

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

†see rule 1(4) as originally promulgated.

"approved diagnostic laboratory" means a laboratory situated in

a Member State or third country approved by the competent

veterinary authority to carry out the diagnostic 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;

"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 of embryos" means a quantity of embryos removed

in one operation from a single female donor and covered by a

single certificate;

"country of collection" means the Member State or third country

in which embryos are produced, collected, processed and, where

necessary, stored, and from which they are sent to a Member State;

"the Director" means the Director responsible for veterinary

services or any veterinarian officer nominated by him;

"embryo" means the initial stage of development of a domestic

animal of the bovine species while it is capable of being transferred

to a recipient dam or a female parent of such species;

"embryo collection team" means an officially approved group of

t e c h ni c i a n s o r st r u c t u r e su p e r v i s e d b y a t e a m v e t e r i n a r ia n

competent to perform the collection, processing and storage of

embryos according to the conditions set out in Schedule A;

"embryo transfer (ET)" means the transfer of embryos from the

female donor to the female recipient, being a practiced method of

multiplying the genetic of animals of the bovine species for the

purpose of these rules. It is the process by which an embryo is

collected (flushed) from one female donor and transferred to

another female recipient to complete the gestation period;

"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;

"gestation period" means the time in which a fetus develops,

beginning with fertilization and ending at birth;

EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES

"health certificate" means a certificate properly issued by the

competent authority in accordance with Schedule C, 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 St ate" m eans a St ate which is a m ember to the

European Union;

"Member State of destination" means such Member State to

which embryos are transported from the embryo collection centre

or estab lish men t o f origi n si tuat ed in the Mem ber State of

collection or in 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;

"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;

"team veterinarian" means the veterinarian responsible for the

supervision of an embryo collection team in accordance with the

conditions laid down in Schedule A;

"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 Member States 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

Community;

"veterinary checks" means checks or import controls carried out

on embryos of domestic animals of the bovine species, either upon

importation from the Community or from a third country subject to

their respective procedures, as 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 for

veterinary checks carried out on imports into the Community, and

under the Principles Governing the Organisation of Veterinary

Checks on Products Entering the Territory of Malta from Third

Countries Regulations, for veterinary checks carried out via border

inspection posts on imports from third countries.

Conditions applying to donor animals

1. For the purposes of embryo collection donor animals shall meet the

following requirements

(a) they shall have spent the previous six months within the Community or

in the third country of collection in at least one herd

(i) which is officially tuberculosis free; and

(ii) which is officially brucellosis free or brucellosis free;

(iii) which is enzootic bovine leucosis free or which, during the three

previous years, has shown no clinical signs of enzootic bovine

leucosis;

EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES

(iv)

which, during the previous year, has shown no clinical signs of

infectious bovine rhinotracheitis/infectious pustular vulvo-

vaginitis;

(b) during the six months preceding embryo collection, donor cows may

have spent successive periods in a maximum of two different herds

meeting the requirements set out above.

2. On the day of embryo collection the donor cow

(a) shall be resident in a holding which is not subject to veterinary

prohibition or quarantine measures;

(b) shall show no clinical signs of disease.

(1)

These rules shall apply to

(a) the use of embryos of domestic animals of the bovine

species as part of an efficient breeding policy which

leads to better productivity and increased margins in

this sector;

(b) the free movement of such embryos which encourage a

rational development, taking into account the use of

optimum production factors;

(c) the fulfilling of guarantees regarding animal health

criteria with regard to intra-Community trade and

imports into the Community of bovine animals from

third countries, so that the risk of animal disease

spreading is eliminated in the case of trade in

embryos;

(d) the harmonization of national animal health provisions

governing intra-Community trade in animals and

animal products, and the necessity to create a

harmonized system for intra-Community trade and

imports into the Community of embryos of domestic

animals of the bovine species;

(e) the obligations of the Member State of collection to

ensure that

(i)

such embryos have been collected and processed

by approved and supervised embryo collection

teams;

(ii) they have been obtained from animals whose

health status is such as to ensure that the risk of

spread of animal disease is eliminated;

(iii) they have been collected, processed, stored and

transported in accordance with the rules which

preserve their health status and are accompanied

during transport to the Member State of

destination by an animal health certificate in

order to ensure that such obligation has been

fulfilled;

(f)

vaccination against foot-and-mouth disease justifying

the maintenance, for fresh embryos, of derogations,

EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES

limited in time, authorizing additional protection by

Member States against that disease;

(g) a list of third countries which should be drawn up,

taking into account animal health criteria, from which

embryos may be imported into the Community,

provided that without prejudice to such a list, approval

or authorisation of imports of embryos may also be

suspended or withdrawn, if it is deemed appropriate to

Member States that animal health criteria and

standards have not been satisfied or fulfilled;

(h) on-the-spot checks which may be carried out in order

to verify compliance with animal health standards and

criteria;

(i)

the prevention against transmission of certain

contagious diseases, whereby import controls should

be carried out when a consignment of embryos 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) These rules shall not apply to embryos resulting from in

vitro fertilization nor to embryos subjected to sexing, splitting

(twinning), cloning or any manipulation which interferes with the

integrity of the zona pellucida.

(3) 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.

(4) 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.

ANIMAL HEALTH CERTIFICATE NO.

ORIGINAL

1. Consignor (name and full address)

2. Member State of collection

3. Consignee (name and full address)

NOTES

(a) A separate certificate shall be issued for each consignment of embryos.

(b) The original of this certificate shall accompany the consignment to the

place of destination.

4. Competent authority

5. Place of loading

6. Name and address of embryo collection team

7. Means of transport

8. Place and Member State of destination

9. Registration number of embryo collection team

10. Number and code-mark of embryo containers

11. Identification of consignment

(a) Number of embryos

(b) Date(s) of collection

(c) Breed

12. I, the undersigned official veterinarian, certify that

(a) the embryos described above were collected, processed and stored and

where consigned to Malta under conditions which comply with the

standards laid down in the Animal Health Conditions Governing Intra-

Community Trade and Importation from Third Countries of Embryos of

Domestic Animals of the Bovine Species Rules; and

(b) the embryos described above were sent to the place of loading in sealed

containers under conditions which comply with the provisions of the

Animal Health Conditions Applicable to Intra-Community Trade and

Importation from Third Countries of Embryos of Domestic Animals of

the Bovine Species Rules.

Done at

Signature

Name and qualification (in block letters)

The competent authority shall ensure that embryos shall

not be sent from Malta to another Member State unless they meet

the following conditions

(a) they shall have been conceived as a result of artificial

insemination with semen from a donor sire or male

parent of the bovine species standing at a semen

collection centre as defined in rule 2(2) of 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;

(b) they shall have been collected from domestic animals

of the bovine species whose health status complies

with Schedule B;

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

by an embryo collection team approved in accordance

with rule 6(1);

(d) they shall have been collected, processed and stored

by the embryo collection team in accordance with

Schedule A; and

(e) they shall be accompanied, during transport to the

Member State of destination, by an animal health

certificate complying with rule 7(1).

(1) Approval of an embryo collection team as provided for

in rule 4(c) shall be granted only where the provisions of Chapter I

of Schedule A are observed and where the embryo collection team

is able to satisfy the other provisions of these rules. Any major

change in the organisation of the team shall be notified to the

competent authority.

(2) The approval of the team shall be renewed whenever the

team veterinarian is replaced or whenever any major changes are

made in its organization or the laboratories or equipment at its

disposal.

(3) The official veterinarian shall supervise observance of the

provisions outlined above. Approval shall be withdrawn where one

or more of the provisions is no longer observed.

(4) The competent authority shall register embryo collection

teams and give a veterinary registration number to each team. The

competent authority shall draw up and keep up to date a list of

embryo collection teams and their veterinary registration numbers

and make it available to the other Member States and to the public.

(1) An animal health certificate drawn up by an official

v e t e r i n a r i a n o f t h e M e m b e r St a t e o f c o l l e c t i o n o n a f o r m

conforming to the specimen in Schedule C shall accompany each

consignment of embryos. A separate certificate shall be issued for

each consignment.

(2)

The animal health certificate shall

(a) consist of a single form and be drawn up in at least the

official language(s) of the Member State of

destination;

(b) be made out to a single consignee; and

(c) accompany the consignment of embryos to its

destination in its original form.

(1) Embryos shall be imported only from those third

countries or parts thereof which appear on a list 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" in rule 2(2). Such list may be supplemented or

amended in accordance with the same procedure.

(2)

In deciding whether a third country or parts thereof may

EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES

appear on the list referred to in sub-rule (1), particular account

shall be taken of

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

animals and wildlife in the third country, with

particular reference to exotic animal diseases, and of

the environmental health situation in that country,

which might endanger animal health in Malta;

(b) the regularity and rapidity of the information supplied

by the third country concerning the existence of

contagious animal diseases in its territory, in particular

those diseases mentioned in lists A and B of the

International Office of Epizootic Diseases;

(c) the rules of the third country on animal disease

prevention and control;

(d) the structure of the veterinary services in the third

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 embryos dispatched from an embryo collection or production

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

referred to in rule 7(1), and for which the competent authority of

the third country concerned is able to give the guarantees that the

following conditions relating to embryo collection and production

team are met

(a) it meets the conditions

(i)

for the approval of embryo collection and

embryo production teams set out in Chapter I of

Schedule A;

(ii) relating to the collection, processing, storage

and transport of embryos by such teams set out

in Chapter II of that Schedule;

(b) it has been officially approved by the competent

authority of the third country for exports to the

Community; and

(c) it is subject to inspections by an official veterinarian

of the third country at least twice a year.

(2) The list of embryo collection or production teams that the

competent authority of the third country appearing on the list

referred to in rule 7(1) has approved in accordance with the

conditions set out in sub-rule (1), and from which embryos may be

dispatched to the Community shall be communicated to the

Commission.

(3) The approval of an embryo collection or production team

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. 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" in rule 2(2).

(1) Importation of embryos from a third country or part

thereof on the list drawn up in accordance with rule 7(1) shall take

place only if the embryos

(a) come from donor animals which, immediately prior to

the collection of their embryos, have remained for at

least six months in the third country concerned, and in

a maximum of two herds complying with at least the

requirements set out in sub-rule (2); and

(b) comply with the animal health requirements adopted in

accordance with the procedure laid down in the

defintion "Standing Committee on the Food Chain and

Animal Health" or "the Committee" in rule 2(2) for

imports of embryos from that country.

(2) In adopting the requirements referred to in sub-rule (1),

particular account shall be given to

(a) the health situation in the area surrounding the place of

embryo collection, 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 concerned in the embryo

collection, including testing requirements;

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

requirements; and

(d) collecting, processing and storing requirements in

relation to embryos.

(3) The reference basis for fixing animal health conditions in

accordance with sub-rules (1) and (2) for tuberculosis, bovine

brucellosis and enzootic bovine leucosis, shall be the standards laid

down in Schedules A and D to the Animal Health Problems

Affecting Intra-Community Trade in Bovine Animals and Swine

Regulations.

(4) Under the procedure laid down in "Standing Committee on

the Food Chain and Animal Health" or "the Committee" in rule

2(2), and on a case-by-case basis, derogations from such provisions

contained in sub-rules (1) and (2), may be decided upon where an

interested third country provides similar and at least equivalent

guarantees with reference to animal health. Rule 4 shall mutatis

mutandis apply.

EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES

(1) Importation of embryos shall only be authorised on

submission of an animal health certificate drawn up and signed by

an official veterinarian of the third country of collection. The

certificate shall

(a) be drawn up in at least the official language or

languages of the Member State of destination and the

official language or languages of the Member State of

collection where the import control provided for in

rule 12 has been carried out;

(b) be made out to a single consignee; and

(c) accompany the embryos in the original.

(2) The animal health certificate shall be on a form conforming

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" in 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 embryos authorised for importation

into the Community by a Member State of destination on the basis

of the control referred to in rule 11 shall, when sent to another

Member State, be accompanied by the original animal health

certificate or an authenticated copy thereof, suitably endorsed, in

either case, by the competent authority responsible for the control

carried out in accordance with rule 11.

Any costs arising from implementation of measures

pursuant to rule 11 shall be chargeable to the consignor or its agent

or representitive, without compensation thereto by the competent

authority.

(1) If a contagious animal disease which may be carried

by embryos breaks out or spreads, or if any other reason connected

with animal health which might endanger the health of the

livestock in Malta so justify

(a) the safeguard measures laid down in regulation 9 of

the Animal Health Problems Affecting Intra-

Community Trade in Bovine Animals and Swine

Regulations, regarding a compulsory national control

programme for contagious diseases may be applied;

and

(b) where all or part of a third country is concerned, the

Member State of destination shall prohibit the

importation of those embryos whether imported

directly or indirectly through another Member State,

either from the whole of the third country or from only

part only thereof.

(2) Measures taken by the competent authority pursuant to sub-

rule (1) and the repeal of such measures shall be communicated

immediately to the other Member States and the Commission

together with the reasons for taking or repealing such measures.

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

definition "Standing Committee on the Food Chain and Animal

Health" or "the Committee" in rule 2(2), it may be decided that

such measures shall be amended, in particular in order to

coordinate them with measures adopted by other Member States, or

that they shall be repealed.

(4) If the situation envisaged in sub-rule (1) arises, and it is

necessary that other Member States also apply the measures taken

under such sub-rule as amended where necessary in accordance

with sub-rule (3), appropriate steps shall be taken in accordance

w i t h t h e p r o c e d u r e l a i d d o w n i n t h e d e f i n i t i o n " St a n d i n g

C o m m i t t e e on t h e F oo d C h a i n a n d A n i m a l H e a l t h " o r "t h e

Committee" in rule 2(2). Resumption of importation from the third

country concerned shall be authorised in accordance with the same

procedure.

(1) Veterinary experts from the Commission may, in

cooperation with the com petent authority or the com petent

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 which 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) If the country of collection does not take such measures

referred to in sub-rule (2), the competent authority may refuse

importation of embryos collected, processed or stored by the

collection team in question or withdraw approval in the case of

third countries, provided it shall be authorised to do so by the

Commission acting in consultation with the Committee.

(4) The general provisions for implementing this rule,

especially as regards the frequency and method of carrying out the

checks referred to in sub-rule (1), shall be laid down in accordance

with the procedure set out in the definition "Standing Committee on

the Food Chain and Animal Health" or "the Committee" in rule

2(2).

Amendments made to the Schedules, in particular to adapt

them to advances in technology, shall be decided in accordance

with the procedure set out in the definition "Standing Committee on

the Food Chain and Animal Health" or "the Committee" in rule

EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES

2(2).

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

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

measures rule 3(3) and (4) 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(3)

and (4) 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.