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Royal Decree 855/1992 Of July 10, That Laying Down The Animal Health Requirements Applicable To Intra-Community Trade And Imports From Third Countries Of Embryos Of Domestic Animals Of The Species B...

Original Language Title: Real Decreto 855/1992, de 10 de julio, por el que se fijan las condiciones de policía sanitaria aplicables a los intercambios intracomunitarios y a las importaciones procedentes de terceros países de embriones de animales domésticos de la especie b...

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TEXT

The implementation of the Community provisions addressing the health problems affecting intra-Community trade in bovine animals and swine and those relating to the importation of bovine animals and swine animals from third countries have made it possible to ensure that the country of origin ensures compliance with the animal health criteria, which makes it possible to avoid the risks of spreading animal diseases.

there was, however, a certain risk of the spread of these diseases in the case of trade in embryos, and a harmonised regime for intra-Community trade and trade was therefore necessary. imports into the European Economic Community of bovine embryos.

This aspect has been considered by Council Directive 89 /556/EEC of 25 September laying down the animal health requirements applicable to intra-Community trade in and imports of embryos animals of the bovine species, which serves as a basis for this provision, and whose guidelines are intended to ensure that the country in which it is obtained must ensure that it comes and is treated in approved and controlled collection centres, in accordance with rules to preserve their correct health status and to be accompanied by a certificate health during their driving to the country of destination in order to ensure compliance with those rules.

Similarly, in the case of embryos from third countries, in order to prevent the transmission of certain contagious diseases, import controls must be carried out on arrival in the territory of the Community of a batch of embryos, except in the case of an external transit.

And, finally, as an additional guarantee, urgent action is expected to be taken when communicable diseases arise in another Member State or in a third country, although taking into account that the protection measures to be taken are appreciated in the same way throughout the Community.

Consequently, it is necessary to incorporate into Spanish legislation the animal health requirements set out in that Directive and this in accordance with the state competence contained in Article 149.1.10 and 16 of the Constitution.

By virtue of the proposal of the Ministry of Agriculture, Fisheries and Food and after deliberation by the Council of Ministers at its meeting on 10 July 1992,

DISPONGO:

Chapter I

General provisions

Article 1.

1. This provision lays down the animal health conditions applicable to intra-Community trade and imports from third countries of fresh and frozen embryos of domestic animals of the bovine species.

2. This Royal Decree shall not apply to embryos resulting from "in vitro" fertilisation, or embryos subjected to sexage, to bisection, to cloning or to any other manipulation affecting the integrity of the translucent zone.

Article 2.

For the purposes of this provision, the definitions set out in Article 2 of Royal Decree 434/1990 of 30 March 1990 laying down health conditions for intra-Community trade shall apply. for live animals of the bovine and porcine species and in Article 2 of Royal Decree 495/1990 of 20 April 1990 laying down the health conditions to be met by live bovine animals and swine imported from third countries Article 2 of Royal Decree 877/1990 of 6 July 1990 laying down the requirements of the animal health requirements for intra-Community trade and imports from third countries of frozen semen of bovine animals of the bovine species.

In addition, it is understood by:

(a) Embrion: The initial stage of development of a domestic animal of the bovine species during the time it is in a position to be transferred to a female recipient.

(b) Embryo Collection Team: A group of technicians or structures, officially approved and supervised by a team veterinarian, whose function consists in collecting, treating and storing the embryos in accordance with the provisions of the in Annex A.

(c) Veterinary equipment: The veterinarian responsible for supervising an embryo collection team in compliance with the provisions of Annex A.

d) Embryo Lot: A certain number of embryos from a single shot and from the same donor and covered by a single certificate.

(e) Country of collection: The Member State or third country in which the embryos are produced, collected, processed and, where appropriate, stored in the embryos and from which they are dispatched to a Member State.

(f) Approved diagnostic laboratory: Any laboratory located in the territory of one of the Member States or of a third country and approved by the competent veterinary authority to carry out the diagnostic tests provided for in this Royal Decree.

Chapter II

Rules for intra-Community trade

Article 3.

1. Only embryos which fulfil the following conditions may be issued to other Member States:

(a) They must have been obtained as a result of artificial insemination with semen coming from a donor in a semen collection centre as defined in Article 2 (b) of the Royal Decree 877/1990.

In exceptional circumstances, the competent authority of the Autonomous Communities, in accordance with Community rules, may authorise the exchange of embryos for certain particular breeds conceived by cover (

) a natural person who is a member of the public health insurance scheme or a person who is a member of the public health insurance scheme;

(b) They must have been collected from domestic animals of the bovine species whose health status complies with the provisions of Annex B to this Royal Decree.

(c) They must have been collected, processed and stored by an embryo collection team approved in accordance with the provisions of Article 5 (1).

(d) They must have been collected, processed and stored by the collection team, in accordance with the provisions of Annex A to this Royal Decree.

(e) During transport to the Member State of destination they must be accompanied by a health certificate in accordance with Article 6 (1).

2. Shipments to Spain from other Member States shall comply with the requirements set out in the previous paragraph.

Article 4.

Consignments of fresh embryos from other Member States that practice vaccination against foot-and-mouth disease are prohibited until they cease to practice the vaccination.

In the case of frozen embryos, donors must come from a holding in which no animal has been vaccinated against foot-and-mouth disease in the 30 days preceding the collection and shall not be the subject of a measure of prohibition or quarantine in application of Royal Decree 434/1990, and in addition the embryos must have been stored in the approved conditions for a minimum period of 30 days prior to the issue.

Article 5.

1. The competent authority of the Autonomous Communities shall give recognition to the embryo collection team provided for in Article 3 (1) (c) and grant the authorization where the provisions of Chapter I are complied with. Annex A and that embryo collection team are in a position to comply with the other provisions of this Royal Decree.

Any change in the organisation of the equipment must be communicated to the competent body of the Autonomous Communities.

The authorization of the equipment shall be renewed whenever the team veterinarian is replaced or important changes are made to his or her organization or to the laboratories or equipment at his disposal.

The official veterinarian will monitor compliance with the above provisions.

The authorization will be removed when one or more of those provisions are no longer satisfied.

2. All approved embryo collection teams shall be entered in the Register of Embryo Collection Teams, set up for this purpose by the competent authority of the Autonomous Communities, each receiving a registration number. veterinarian.

3. The Autonomous Communities shall communicate to the Ministry of Agriculture, Fisheries and Food the names of the veterinarians of the collection centres and their respective territories.

Article 6.

1. Consignments of embryos shall be accompanied by a health certificate issued in accordance with the model in Annex C by an official veterinarian of the Member State of collection.

A separate certificate will be issued for each batch.

2. The health certificate shall:

(a) Constar of a single sheet and at least be drawn up in the official languages of the Member State of destination. Where Spain is a country of collection or destination, it shall be drawn up, at least, in the official Spanish language of the State.

b) Expected for a single recipient.

c) accompany the batch of embryos to their destination in their original copy.

Chapter III

Third country imports

Article 7.

1. Only the importation of embryos from third countries or parts thereof, listed in a list drawn up by the Commission of the European Communities and published, as well as subsequent amendments thereto, shall be authorised. 'Official Journal' of the European Communities.

2. Without prejudice to the above paragraph, the list referred to therein, and subsequent amendments thereto, shall be published in the 'Official Gazette of the State', on the initiative of the Ministry of Agriculture, Fisheries and Food, for a better understanding of stakeholders.

Article 8.

Only the importation of embryos of collection, treatment or storage equipment from third countries, referred to in the list approved by the Commission of the European Communities, shall be authorised.

Article 9.

The Ministry of Agriculture, Fisheries and Food shall authorise the importation of embryos from the territory of a third country, or part thereof, on the list established in accordance with Article 7 (1) only if the embryos come from donor females which, immediately prior to their collection, have remained for at least six months in the territory of the third country concerned and, at most, have remained in two gangries which satisfy at least the conditions (a) health police with regard to tuberculosis, bovine brucellosis and enzootic bovine leucosis established in Royal Decree 434/1990.

Article 10.

The Ministry of Agriculture, Fisheries and Food shall only authorise the importation of embryos if a health certificate issued and signed by an official veterinarian of the third country of collection is presented.

This certificate must:

(a) Be drafted, at least, in the official Spanish language of the State and in one of the official languages of the Member State of destination, if this is not Spain.

b) To accompany the embryos with an original copy.

c) Expected for a single recipient.

2. The health certificate shall conform to the model established by the Community authorities.

Article 11.

1. Each batch of embryos arriving in Spanish customs territory shall be subject to a check by the official veterinary services of the Customs and dependent Customs of the Ministry of Agriculture, Fisheries and Food before being released for free circulation. or to be admitted under a customs procedure and for the purpose of preventing their entry into or movement in the national territory, where the import control reveals any of the circumstances specified below, shall communicate them to the competent authorities of the Customs:

(a) that the embryos do not come from the territory of any third country or part thereof listed in accordance with Article 7 (1).

(b) The embryos have not been collected, processed or stored by any of the embryo collection teams listed in the list provided for in Article 8 (1).

(c) The embryos come from the territory of a third country or part thereof, where the importation of the embryos is prohibited in accordance with Article 14 (1).

(d) that the health certificate accompanying the embryos does not comply with the requirements laid down in Article 10 and set out in applications thereof.

This paragraph shall not apply to consignments of embryos arriving in the Spanish customs territory subject to a customs transit procedure for dispatch to a place of destination situated outside the Community territory.

However, it will be applicable in case of waiver of customs transit in the course of transport through the Spanish territory.

2. The Ministry of Agriculture, Fisheries and Food may take the necessary measures, including quarantine, to obtain safe testing of the embryos of which they suspect are contaminated by pathogenic germs.

3. If the importation of the embryos has been prohibited for any of the reasons set out in paragraphs 1 and 2 and the exporting third country does not authorize the re-dispatch of the embryos within 30 days, the Ministry of Agriculture, Fisheries and Power may order its destruction.

Article 12.

The entry into, or movement into, the territory of the State of each consignment of embryos whose importation into the Community has been authorised by another Member State, on the basis of the check referred to in Article 11 (1), require that it be accompanied by the original of the health certificate or an authenticated copy thereof, duly endorsed by the competent authority responsible for that control.

When from Spain they are sent to the territory of another Member State, these documents, which must accompany each batch of embryos, must be duly endorsed by the Ministry of Agriculture, Fisheries and Food.

Article 13.

The costs incurred in applying the measures adopted pursuant to Article 11 (2) and (3) shall be borne by the sender, the consignee or their respective representatives, without the right to compensation. from the State.

Chapter IV

Safeguarding and control measures

Article 14.

1. Where there is a risk of disease spreading among animals, the following shall be adopted by the Ministry of Agriculture, Fisheries and Food on entry into the territory of Spain of embryos from another Member State. measures:

(a) to prohibit or temporarily restrict the entry of embryos from the parts of the territory of the Member State where an epizootic disease has been declared.

(b) to prohibit or temporarily restrict the entry of embryos from the whole of the territory of the other Member State in the event that an epizootic disease shows signs of extension or if another disease is manifested of animals, severe or contagious.

The Ministry of Agriculture, Fisheries and Food shall, through the competent authority, inform the other Member States and the Commission without delay of the manifestations in Spanish territory of any disease. epizootic and the measures taken to combat the disease. It will also give you an account without delay of the disappearance of the disease.

Subject to the provisions of Articles 8 and 9, and if a contagious disease of animals which may spread by embryos and which may affect the health situation in a third country is manifested or extended in a third country. If Spain is the country of entry, it will ban the importation of embryos, whether it is a matter of the origin of the animal, or the fact that it is the country of entry, the Ministry of Agriculture, Fisheries and Food. direct importation as in the case of indirect importation carried out through another Member State, being indifferent to such an effect that the embryos come from the third country as a whole or only from a part of the territory of the third country.

2. The measures taken by the Ministry of Agriculture, Fisheries and Food on the basis of the above paragraph, as well as their repeal, shall be communicated to the other Member States and to the Commission, with the following reasons: justify.

3. Consignments of embryos from Spain to other Member States, either directly or indirectly, may be subject to the measures provided for in paragraph 1 of this Article, if the same circumstances apply.

4. The resumption of imports from third countries shall be authorised, where appropriate, following the Community decision.

Additional disposition first.

This provision is made under Article 149.1.10 and 16 of the Constitution.

Additional provision second.

1. The Autonomous Communities shall draw up the list of approved embryo collection teams, with their veterinary registration numbers, and notify it to the Ministry of Agriculture, Fisheries and Food, in order to arrange for them to be sent to the Commission. European Communities and the other Member States.

2. Where the Autonomous Communities consider that the provisions governing the authorisation are not observed by an embryo collection team from another Member State, they shall notify the Ministry of Agriculture, Fisheries and Food for the purposes of inform the competent authority of that Member State, of which it shall seek the decisions taken in this respect and the reasons for its use.

Also, if the Autonomous Communities estimate that the necessary measures have not been taken or are inadequate, they shall notify the Ministry of Agriculture, Fisheries and Food for their report to the Commission of the European Communities.

3. The Ministry of Agriculture, Fisheries and Food shall be responsible for the communication to the Commission of the European Communities of the Spanish laboratories recognised by the Autonomous Communities for carrying out the examinations.

Additional provision third.

This provision shall not apply to embryos collected, processed and stored in the Member States before 1 January 1991.

Additional provision fourth.

Until the date of entry into force of the decisions taken pursuant to Articles 8 and 9, they shall not apply to imports of embryos from third countries which are more favourable than those resulting from the Chapter II, concerning intra-Community trade.

Additional provision fifth.

1. Article 2.15 of Royal Decree 434/1990 of 30 March 1990 laying down the health conditions for intra-Community trade in live animals of the bovine and porcine species shall read as follows:

" Article 2.15. Official veterinarian: The veterinarian designated by the Autonomous Communities for the purposes of applying this Royal Decree. "

2. Article 2 (c) of Royal Decree 877/1990 of 6 July 1990 laying down the animal health requirements applicable to intra-Community trade in and imports of frozen semen of domestic animals of the bovine species shall be the subject of the following wording:

" Article 2.c). Official veterinarian: The veterinarian appointed by the competent authority of a Member State or a third country. In Spain, the 'official veterinarian' shall be designated by the Ministry of Agriculture, Fisheries and Food for imports from third countries and by the Autonomous Communities for intra-Community trade. '

First disposition first.

The Minister of Agriculture, Fisheries and Food is empowered to lay down the provisions necessary for the implementation and application of the provisions of this Royal Decree and, in particular, to amend the Annexes to the This provision, in order to adapt them to Community provisions.

Final disposition second.

This Royal Decree shall enter into force on the day following that of its publication in the "Official Gazette of the State".

Given in Madrid to July 10, 1992.

JOHN CARLOS R.

The Minister of Agriculture, Fisheries and Food,

PEDRO SOLBES MIRA

ANNEX A

Chapter I

Conditions for the authorization of embryo collection teams

In order to be authorised, each embryo collection team must meet the following requirements:

A) The collection, treatment and storage of embryos shall be carried out by a team veterinarian or, under his responsibility, by one or more competent technicians and trained in the hygiene methods and techniques.

B) Act under the general control of the official veterinarian and under his authority.

C) shall have at its disposal, for the examination, treatment and packaging of embryos, permanent or mobile laboratory facilities, composed of at least one working surface, a microscope and a team cryogenic,

D) You will have at your disposal, if the lab has a permanent site:

(a) A local for the handling of attached embryos, but physically separated from the area in which the donor animals are handled during collection.

(b) A local or area equipped for the cleaning and sterilisation of the instruments and equipment used for the collection and handling of embryos.

E) shall have at its disposal, in the case of a mobile laboratory, a part of the specially equipped vehicle, consisting of two separate sections:

a) A clean area, intended for the examination and manipulation of embryos, and

b) An area intended to house equipment and materials that come into contact with donor animals.

Every mobile laboratory will always be in contact with a permanent site laboratory, with a view to the sterilization of its equipment and to the supply of fluids and other products needed for collection and handling. of embryos.

Chapter II

Conditions relating to collection activities carried out by authorised embryo collection teams

1. Collection and treatment.

A) The embryos shall be collected and processed by authorised collection teams, without coming into contact with other batches of embryos which do not comply with the requirements of this Royal Decree.

B) Embryos shall be collected in a place that is isolated from other parts of the enclosure or establishment and is in good conservation status and is easy to clean and disinfect.

C) Embryos shall be treated (examined, washed, handled and placed in sterile identified containers), either in a permanent laboratory or in a mobile laboratory located in an area which is the subject of prohibition or quarantine.

(D) The material which is in contact with the embryos or the donor animal in the collection and treatment stages shall be disposable or subjected to adequate disinfection and sterilisation before reusing it.

E) The products of animal origin used during the collection of embryos and in the means of transport shall be from sources which do not pose a risk to the animal health status of the animals or receive prior treatment to the animals. use to remove that risk.

F) The storage and transport containers will be properly disinfected or sterilized before each filling operation begins.

G) The cryogenic agent used has not previously been used for other products of animal origin.

H) Each embryo container, as well as the container in which embryos are stored and transported, shall be clearly marked by code so that the date of collection of the embryos can be easily determined. The breed and identification of male and female donors and the team's registration number. The form and characteristics of this code shall be determined in accordance with the procedure laid down by the Community authorities.

I) The embryo shall be washed at least ten times in a special liquid, which shall be renewed each time and which, unless otherwise decided in application of (M), shall contain the trypsin, in accordance with the internationally recognised procedures. Each wash shall consist of a centesimal dissolution of the preceding washing, using a sterile macropipette to transfer the embryo each time.

J) After the last washing, each of the embryos will be examined microscopically on its entire surface, to check that the transparent zone is intact and no substances are attached to it.

K) Each batch of embryos that

successfully passed the test set out in point (J) shall be deposited in a sterile container, which shall be marked in accordance with the letter H) and shall be sealed immediately thereafter.

L) If necessary, each embryo shall be frozen as soon as possible and stored in a local subject to the control of the team veterinarian and regularly inspected by the official veterinarian.

(M) In accordance with the provisions laid down by the Community authorities, the competent Animal Health Services of the Autonomous Communities shall draw up a protocol on rinsing and washing liquids. authorised, the washing techniques and, if necessary, the enzyme treatments, as well as the means of conservation authorised for the transport.

Until the adoption of a protocol on enzyme treatments, national rules on the use of trypsin will continue to apply.

N) Each collection team shall take routine samples of the products resulting from the official examination of the equipment, such as rinsing and washing liquids, disintegrated embryos, unfertilised eggs, etc., for detection of possible bacterial and viral contamination. The procedure for the collection of samples, the criteria for the examinations and the levels to be achieved shall be those laid down by Community legislation, in accordance with the procedure laid down in Article 18 of the Directive. 89 /556/EEC.

O) Each collection team must keep track of the embryo collection activities carried out in the last 12 months before and after storage. Such registration shall include:

a) The race, age and identification of the corresponding donor animals.

b) The place of collection, treatment and storage of the embryos collected by the team.

c) The identification of the embryos with details of their destination, if known.

2. Storage.

The embryo collection teams shall ensure that the embryo collection teams are stored, at appropriate temperatures, in premises approved for that purpose by the official veterinarian.

To be authorized, those locales must:

(a) Contar at least one local that can be locked and used exclusively for the storage of embryos.

b) Be easy to clean and disinfect.

(c) Dispose of records in which all entries and exits of embryos are to be permanently entered. These records shall specify in particular the final destination of the embryos.

d) Be inspected by the official veterinarian.

The competent authority of the Autonomous Communities may authorise the storage of semen complying with the provisions of Royal Decree 877/1990.

3. Transport.

Embryos intended for trade shall be transported, under satisfactory hygiene conditions, in sealed containers from authorised storage premises until their arrival at the place of destination.

The containers will be marked in such a way as to match the number listed in the health certificate.

ANNEX B

Conditions for donor animals to be required

1. With a view to the collection of embryos, donor animals must satisfy the following conditions:

A) During the preceding six months, they shall have remained in the territory of the European Economic Community or in the third country of collection in at least one herd:

a) Officially tuberculosis-free.

b) Officially free from brucellosis or brucellosis-free.

(c) Indemne of enzootic bovine leukosis or who have not, for the last three years, presented any clinical sign of enzootic bovine leukosis.

d) In which no clinical sign of infectious bovine rhinotracheitis/infectious purulent vulvovagitis has been detected in the previous year.

B) During the six months prior to the collection of embryos, the donor females shall have spent successive periods in two different flocks, at most, meeting the conditions set out above.

2. At the time of collection, the donor females:

(a) They shall be located in an establishment which is not subject to prohibition or veterinary quarantine measures.

b) They must not show any clinical signs of disease.

ANNEX C

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