Domestic Animals of the Bovine Species, Rules 2010

L.N. 555 of 2010

VETERINARY SERVICES ACT

(CAP. 437)

Animal Health Conditions Governing Intra-Community

Trade and Importation from Third Countries of Embryos 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 and after having consulted the Veterinary

Services Authority, has made the following rules:-

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

Governing Intra-Community Trade and Importation from Third

Countries of Embryos of Domestic Animals of the Bovine Species,

Rules 2010.

(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.

(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 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 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;

“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 2009;

“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 technicians or structure supervised by a team

veterinarian competent to perform the collection, processing

and storage of embryos according to the conditions set out in

Schedule A to these rules;

“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 2009;

“gestation period” means the time in which a fetus

develops, beginning with fertilization and ending at birth;

“health certificate” means a certificate properly issued

by the Competent Authority in accordance with Schedule C

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 embryos are transported from the embryo

collection centre or establishment of origin situated in the

Member 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 2009;

“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 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;

“team veterinarian” means the veterinarian responsible

for the supervision of an embryo collection team in

accordance with the conditions laid down in Schedule A to

these rules;

“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 2009 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, 2003 for veterinary checks L.N. 356 of 2003.

carried out via border inspection posts on imports from third

countries.

(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,

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) T h e s e m e a s u r e s s h a l l i n c l u d e t h e d i r e c t

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 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 sub-rule (2) of rule 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 2010;

(b) they shall have been collected from domestic

animals of the bovine species whose health status complies

with Schedule B to these rules;

(c) they shall have been collected, processed and

stored by an embryo collection team approved in accordance

with sub-rule (1) of rule 6 hereof;

(d) they shall have been collected, processed and

stored by the embryo collection team in accordance with

Schedule A to these rules; and

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

Member State of destination, by an animal health certificate

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

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

for in paragraph (c) of rule 4 hereof shall be granted only where the an

provisions of Chapter I of Schedule A to these rules 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 veterinarian of the Member State of collection on a form

conforming to the specimen in Schedule C to these rules 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 accordance with the procedure laid down in the definition

“Standing Committee on the Food Chain and Animal Health” or

“the Committee” in sub-rule (2) of rule 2 of these rules. Such list

may be supplemented or amended in accordance with the same

procedure.

(2) In deciding whether a third country or parts thereof

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) 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 Conditions relating to

imports of embryos dispatched from an embryo collection or embryo

production team situated in one of the third countries appearing on teams.

the list referred to in sub-rule (1) of rule 7 hereof, 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 to these rules;

(ii) relating to the collection, processing, storage

and transport of embryos by such teams set out in

Chapter II of that Schedule to these rules;

(b) it has been officially approved by the competent

authority of the third country for exports to the Community;

(c) it is 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 sub-rule (1) of rule 7 of these rules has approved

in accordance with the conditions set out in sub-rule (1) hereof, 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) hereof, 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 sub-rule (2) of rule 2 of these rules.

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

thereof on the list drawn up in accordance with sub-rule (1) of rule

7 of these rules 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) hereof; 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 sub-rule (2) of rule 2

of these rules for imports of embryos from that country.

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

(1) hereof, 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) hereof 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, 2004.

(4) Under the procedure laid down in “Standing

Committee on the Food Chain and Animal Health” or “the

Committee” in sub-rule (2) of rule 2 of these rules, and on a case-

by-case basis, derogations from such provisions contained in sub-

rules (1) and (2) hereof, may be decided upon where an interested

third country provides similar and at least equivalent guarantees

with reference to animal health. Rule 4 of these rules shall mutatis

mutandis apply.

(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 of these rules

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 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 by

Territory of Malta from Third Countries Regulations, 2003 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 those 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 of these rules 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 of these rules.

Any costs arising from implementation of measures

pursuant to rule 11 hereof, 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, 2004

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

rules, 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) hereof

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

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 Competent Authority or the 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 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) hereof, 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) hereof, 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 sub-rule (2) of rule 2 of these rules.

Amendments made to the Schedules to these rules,

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

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

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

measures of sub-rules (3) and (4) of rule 3 of these rules shall apply

to it.

(2) Any right given to the Competent Authority under

these rules to apply all such necessary measures prescribed in sub-

rules (3) and (4) 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 A

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.

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

(i)

Each embryo shall be washed at least 10 times in a special fluid

B

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

rules. 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 12 months before and 12 months after storage

including

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

concerned,

B

(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.

B

Schedule B

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;

(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.

Schedule C

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 2010; 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

B

Bovine Species, Rules 2010.

Done at

Signature

Name and qualification (in block letters)

Stamp

B

€2.05