Decree No. 380 / 2003 Coll.
Ordinance on animal health requirements governing trade in semen, ova and embryos and on animal health conditions governing their importation from third countries
Valid
Order
Effective from 01.05.2004
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380
DECLARATION
of 3 November 2003
concerning animal health requirements governing trade in and veterinary conditions for imports from third countries of semen, ova and embryos
The Ministry of Agriculture provides pursuant to Section 78 of Act No. 166 / 1999 Coll., on Veterinary Care and on the amendment of certain related laws (Veterinary Act), as amended by Act No. 131 / 2003 Coll., ("the Act ') for the implementation of Sections 28 (5), 31 (3) (a) and 34 (5) of the Act:
Preliminary provisions
Subject matter
(1) This decree implements the relevant provisions of the European Union1) and provides for
(a) the animal health requirements for trade in semen, ova and embryos (germ products) of bovine, porcine, ovine, caprine and equine animals with Member States of the European Union (Member State);
(b) animal health conditions for imports of germ products from countries which are not Member States ("third countries"),
(c) the conditions for issuing the health certificate accompanying germinal products.
(2) This decree does not apply to:
(a) the organisation of artificial insemination as a whole, in particular for the distribution of semen;
(b) embryos obtained from transfer of nuclei;
(c) semen of domestic animals of the bovine species collected and treated in a Member State before 1 January 1990.
Basic concepts
For the purposes of this decree:
(a) bovine animals of the bovine species (Bos) including buffalo species (Bison bison) and buffalo (Bubalus bubalis) kept or kept as farm animals,
(b) pigs - animals of the genus Sus reared or kept as farm animals,
(c) equidae - animals of horse and donkey species and their cross-breeds and animals of zebra species,
(d) semen of domestic animals of the bovine species, prepared or diluted,
(e) porcine semen ejaculate, fresh, prepared or diluted,
(f) embryo of bovine animals - the initial stage of development of bovine animals which may be transferred to the breeding animal (recipient),
(g) semen collection centre - approved and controlled undertaking or other establishment in the territory of the Member State or third country in which bovine semen intended for artificial insemination is produced;
(h) semen collection centre - approved and controlled undertaking or other establishment in the territory of the Member State or third country in which semen of other species of livestock is produced;
(i) a bank of semen - an approved and controlled undertaking or other establishment in the territory of the Member State or third country in which bovine semen for artificial insemination is stored;
(j) collection - the quantity of semen collected in one single animal,
(k) embryo collection team - an approved group of technicians under the supervision of a veterinarian who is competent to carry out the collection, processing and storage of embryos on the basis of compliance with the requirements laid down in this Decree;
(l) embryo production team - embryo collection team approved on the basis of compliance with the requirements laid down in this Decree also for in vitro fertilisation under the supervision of a veterinarian,
(m) consignment - consignment of semen for which one health certificate is issued; Where an embryo is involved, the consignment shall mean the quantity of embryos derived from one collection from one donor bearing one health certificate,
(n) country of collection - the Member State or third country where the semen is collected and dispatched to the Member State; if embryos are taken, the country of collection shall mean the Member State or third country where the embryos are produced, collected, processed, stored where appropriate and dispatched to the Member State;
(o) an approved laboratory - a laboratory located in the territory of a Member State or a third country approved by the competent veterinary authority for carrying out the tests provided for in this decree,
(p) semen storage centre - approved and controlled establishment or other establishment in the territory of the Member State or third country in which the semen of the ovine, caprine or equine species is stored.
Veterinary requirements for trade in semen of domestic animals of the bovine species
(1) Cattle semen may be traded if:
(a) has been collected and treated and, where appropriate, stored for the purposes of artificial insemination in an semen collection centre or bank approved from a veterinary point of view for trade with Member States (hereinafter referred to as "trade");
(b) has been collected from an animal of a bovine species whose health status complies with the requirements laid down in Annex 2 to this Regulation;
(c) has been collected, processed, stored and transported in accordance with the requirements set out in Annexes 1 and 3 to this Regulation;
(d) during transport to the Member State of destination, it shall be accompanied by the original of the health certificate drawn up by the official veterinarian of the Member State of collection in accordance with the model laid down in European Union rules.
(2) The semen of bulls that have been vaccinated against foot-and-mouth disease cannot be refused in trade.
(3) Where the semen referred to in paragraph 2 originates from a bull vaccinated against foot-and-mouth disease during the 12 months prior to collection, 5% of the semen (at least 5 pellet) from each collection to another Member State shall be subjected to an approved laboratory of the Member State of destination or an approved laboratory tested for the isolation of the foot-and-mouth disease virus with negative results.
(1) The conditions for approval of a semen collection centre or bank from a veterinary point of view are set out in Annex 1 to this Regulation.
(2) If the conditions for approval of a semen collection centre or bank of semen are not complied with, the approval of the semen collection centre or bank may be suspended or withdrawn in accordance with Articles 49 (1) (h) (1) or 49 (1) (d) of the Act, as the case may be; In accordance with Article 48 (1) (o) (2) of the Act, the central veterinary administration shall inform the European Commission ("the Commission ') and the Member States of such measures.
(3) The Central Veterinary Administration shall, in accordance with Article 48 (1) (j) of the Act, maintain, publish on the website of the State Veterinary Administration and update the list of approved semen collection centres and semen banks with their veterinary approval numbers.
Where bovine semen is suspected of being infected or contaminated by pathogenic micro-organisms, the Regional Veterinary Administration shall take the necessary measures, in accordance with the law, including the storage of the semen in quarantine to confirm or exclude such suspicion.
Veterinary requirements for trade in porcine semen
Pigs semen may be traded if:
(a) has been collected and processed for artificial insemination at a semen collection centre approved from a veterinary point of view for trade;
(b) has been collected from an animal of a species of pig whose health status complies with the requirements laid down in Annex 5 to this Regulation;
(c) has been collected, processed, stored and transported in accordance with the requirements set out in Annexes 4 and 6 to this Regulation;
(d) during transport to the Member State of destination, it shall be accompanied by the original of the health certificate drawn up by the official veterinarian of the Member State of collection in accordance with the model laid down in European Union rules.
(1) The conditions for approval of the semen collection centre from a veterinary point of view are set out in Annex 4 to this Regulation.
(2) If the conditions for approval of the semen collection centre are not complied with, the approval of the semen collection centre may be suspended or withdrawn in accordance with Articles 49 (1) (h) (1) or 49 (1) (d) of the Act; The central veterinary administration shall inform the Commission and the Member States of such measures in accordance with Article 48 (1) (o) (2) of the Act.
(3) The Central Veterinary Administration shall, in accordance with Article 48 (1) (j) of the Act, maintain, publish on the website of the State Veterinary Administration and update the list of approved semen collection centres with their assigned veterinary approval numbers.
(1) Where pigs are suspected of being infected or contaminated with pathogenic micro-organisms, the Regional Veterinary Administration shall take the necessary measures, in accordance with the legislation, including the storage of semen in quarantine to confirm or exclude such suspicion.
(2) The storage of porcine semen in quarantine is possible only if this does not affect its viability.
Veterinary requirements for trade in bovine embryos
Bovine embryos may be traded if:
(a) have been conceived by artificial insemination or in vitro fertilisation of a bull from a semen collection centre or from a semen imported from a third country under the conditions laid down in this Regulation or, where appropriate, in the case of embryos of certain specific breeds, and if the Commission so decides - if the bulls of which the health status of the animals complies with the requirements laid down in Annex 2 thereto,
(b) have been collected from an animal of bovine species whose health status complies with the requirements set out in Annex 8 to this Regulation;
(c) have been collected, processed and stored by an approved embryo collection team in accordance with the requirements set out in Annex 7 to this Regulation;
(d) during transport to the Member State of destination, they shall be accompanied by the original of the health certificate drawn up by the official veterinarian of the Member State of collection in accordance with the model laid down in European Union rules.
(1) The conditions for approval of the embryo collection team and embryo production team from a veterinary point of view are set out in Annex 7 to this Regulation. the approval must be renewed after each exchange of the veterinarian of the embryo collection team and after any major change in its organisation or in the laboratory or establishment at its disposal.
(2) If the conditions for approval of the embryo collection team are not complied with, approval of the embryo collection team may be suspended or withdrawn in accordance with Articles 49 (1) (h) (1) or 49 (1) (d) of the Act; The central veterinary administration shall inform the Commission and the Member States of such measures in accordance with Article 48 (1) (o) (2) of the Act.
(3) The Central Veterinary Administration shall, in accordance with Article 48 (1) (j) of the Act, maintain, publish on the website of the State Veterinary Administration and update the list of approved embryo collection teams with their assigned veterinary approval numbers.
Veterinary requirements for trade in semen of ovine, caprine and equine animals
The semen of ovine, caprine and equine animals may be traded if:
(a) has been collected, processed and stored in relation to the need for artificial insemination in a semen collection centre or in a semen storage centre approved for trade from a veterinary point of view, or, if ovine and caprine animals, on a holding which complies with the requirements laid down in a specific legislation, 2)
(b) has been collected from animals meeting the requirements set out in Part B of Annex 9 to this Regulation;
(c) has been collected, processed, stored, stored and transported in accordance with the requirements set out in Part C of Annex 9 to this Regulation;
(d) during transport to the Member State of destination, it shall be accompanied by the original of the health certificate drawn up by the official veterinarian of the Member State of collection in accordance with the model laid down in European Union rules.
(1) The conditions for approval of the semen collection centre and the semen storage centre from a veterinary point of view are set out in Part A of Annex 9 to this Regulation.
(2) Where the conditions for the approval of a semen collection centre or semen storage centre are not complied with, approval may be suspended or withdrawn in accordance with Articles 49 (1) (h) (1) or 49 (1) (d) of the Act, as the case may be; The central veterinary administration shall inform the Commission and the Member States of such measures in accordance with Article 48 (1) (o) (2) of the Act.
(3) The Central Veterinary Administration shall, in accordance with Article 48 (1) (j) of the Act, maintain, publish on the website of the State Veterinary Administration and update the list of approved semen collection centres and semen storage centres with their assigned veterinary approval numbers.
Veterinary requirements for trade in egg cells and embryos of ovine, caprine, porcine and equine animals
(1) Egg cells and embryos of the ovine, caprine, porcine and equine species may be traded if:
(a) have been collected by an approved embryo collection team or produced by an approved embryo production team; the conditions for approval of the embryo collection team and embryo production team are set out in Part A of Annex 9 to this Regulation,
(b) have been collected from animals meeting the requirements set out in Part D of Annex 9 to this Regulation;
(c) have been collected, treated, stored in an appropriate laboratory, stored and transported in accordance with Part C of Annex 9 to this Decree;
(d) during transport to the Member State of destination, they shall be accompanied by the original of the health certificate drawn up by the official veterinarian of the Member State of collection in accordance with the model laid down in European Union rules.
(2) The semen used to inseminate donors must comply with the requirements laid down in Section 6, if it is for pigs or in Section 12, if it is for sheep, goats and equidae.
Animal health conditions for imports of bovine semen from third countries
(1) The importation from a third country of semen of domestic animals of the bovine species which:
(a) it comes from a third country or part thereof, as the case may be, on a list of third countries drawn up and published by the Commission from which bovine semen may be imported into the territory of the Member States (hereinafter referred to as "the territory of the European Union"),
(b) comes from a semen collection centre or bank in a third country approved by the competent authority of a third country for the export of semen to the European Union and listed in the semen collection centres and banks established and published by the Commission from which bovine semen may be dispatched to the European Union.
(2) Cattle semen must:
(a) come from animals which have been kept for at least 6 months immediately prior to collection in the territory of a third country listed in paragraph 1 (a);
(b) comply with the requirements laid down by the Commission for imports of semen of domestic animals of the bovine species from the third country concerned, in particular taking into account the requirements in respect of tuberculosis and bovine brucellosis laid down in a separate legislation, (3) where appropriate, where the Commission so decides in a particular case, the animal health guarantees provided by the third country concerned which are at least equivalent to those requirements,
(c) be accompanied, during transport, by the original of a correctly completed health certificate drawn up by an official veterinarian of the third country in which the semen was collected in accordance with the model laid down in European Union legislation.
(3) Paragraph 3 (2) and (3) shall apply mutatis mutandis to imports of bovine semen from a third country.
Animal health conditions for imports of porcine semen from third countries
(1) Porcine semen may be imported from a third country which:
(a) comes from a third country or part thereof, as the case may be, on a list of third countries drawn up and published by the Commission from which pig semen may be imported into the territory of the European Union;
(b) come from a semen collection centre in a third country approved by the competent authority of a third country for the export of semen to the European Union and included in the list of semen collection centres established and published by the Commission from which porcine semen may be dispatched to the European Union.
(2) Swine semen must:
(a) come from animals which have been kept for at least 3 months immediately prior to collection in the territory of a third country listed in paragraph 1 (a);
(b) comply with the requirements laid down by the Commission for the importation of semen of domestic animals of the porcine species from the third country concerned, in particular taking into account the requirements set out in Article 6 et seq. and Annexes 4 to 6 thereto, or, if the Commission so decides in a particular case, the animal health guarantees provided by the third country concerned which are at least equivalent to those requirements;
(c) be accompanied, during transport, by the original of a correctly completed health certificate drawn up by an official veterinarian of the third country in which the semen was collected in accordance with the model laid down in European Union legislation.
(3) Paragraph 8 shall apply mutatis mutandis to imports of porcine semen from a third country and to the storage of porcine semen in quarantine.
Animal health conditions for imports of bovine embryos from third countries
(1) Embryos of bovine animals may be imported from a third country which:
(a) they come from a third country or part thereof, as the case may be, on a list of third countries drawn up and published by the Commission from which bovine embryos may be imported into the territory of the European Union;
(b) have been collected by an embryo collection team authorised in a third country to collect, process or store embryos intended for Member States and listed by the Commission.
(2) Bovine embryos must:
(a) be collected from animals which:
1. immediately prior to collection of the embryos have been kept for at least 6 months in the territory of a third country listed in paragraph 1 (a) in no more than two herds meeting the requirements relating to tuberculosis, bovine brucellosis and enzootic bovine leukosis and listed in the Annexes to the specific legislation. 3) Where the Commission so decides in a particular case, it is sufficient that bovine embryos comply with the animal health guarantees provided by the third country concerned, provided that such guarantees are similar and at least equivalent to those requirements,
2. come from a holding in which no animal has been vaccinated against foot-and-mouth disease within the 30 days prior to collection of the embryos and which is not subject to any prohibited emergency veterinary measure or quarantine measure;
(b) comply with the requirements laid down by the Commission for imports of embryos from the third country concerned;
(c) be accompanied, during transport, by the original of a correctly completed health certificate drawn up by an official veterinarian of the third country in which the embryos were collected in accordance with the model laid down in European Union rules.
(1) Only frozen embryos may be imported from third countries where vaccination against foot-and-mouth disease is carried out.
(2) Before dispatch, the frozen embryos referred to in paragraph 1 shall be stored under the approved conditions set out in Annex 7 to this Regulation for at least 30 days.
Animal health conditions for imports of germ products of pigs, sheep, goats and equidae from third countries
(1) Imports from a third country may be made of germ products of pigs, sheep, goats and equidae which:
(a) they come from a third country or part thereof, as the case may be, on a list of third countries drawn up and published by the Commission from which germinal products may be imported into the territory of the European Union;
(b) meet or be at least equivalent to the requirements laid down for trade therein;
(c) they are accompanied, during transport, by the original of the health certificate drawn up by the official veterinarian of the third country in which the germinal products were collected in accordance with the model laid down in European Union rules.
(2) The health certificate referred to in paragraph 1 (c) must certify that the germinal products comply with the requirements referred to in paragraph 1 (b) and come from approved semen collection centres or semen storage centres, embryo collection teams or embryo production teams providing the required guarantees.
Conditions for issuing veterinary certificates accompanying germinal products
(1) The health certificate accompanying germ products intended for trade must be:
(a) drawn up in at least one of the official languages of the Member State of collection and one of the official languages of the Member State of destination;
(b) on a single sheet of paper; where this is not possible and the health certificate is made out on several sheets, those sheets shall be suitably joined and labelled to form an integral whole;
(c) intended for one consignee;
(d) bear the stamp and signature of the official veterinarian in a colour different from that of the other text and the serial number.
(2) The health certificate accompanying germ products intended for trade must accompany the consignment to its destination.
(3) Unless otherwise specified, the period of validity of the health certificate accompanying germinal products intended for trade shall be 10 days from the date of issue.
(1) The health certificate accompanying germ products imported from a third country must:
(a) be drawn up in at least one of the official languages of the Member State of destination and in one of the official languages of the Member State where the veterinary inspection is carried out under a specific legislation; 4)
(b) satisfy the requirements set out in § 20 (1) (b) to (d).
(2) The health certificate accompanying germ products imported from a third country must accompany the consignment to its destination.
Common provisions
Conditions for the approval of a semen collection centre or bank from a veterinary point of view, for the approval of a semen collection centre from a veterinary point of view, for the approval of an embryo collection team and of an embryo production team from a veterinary point of view shall also apply if the germ products put into circulation in the Czech Republic.
(1) In the event of suspected non-compliance with the provisions of this Order, as well as in case of doubt as to animal health or the quality of semen, ova and embryos, the Regional Veterinary Administration shall carry out any checks for which it is legally entitled.
(2) Where the provisions of this Regulation or of European Union provisions have been found to be infringed, in particular if the germinal products do not comply with the requirements laid down, if the non-compliance of the veterinary certificate or other document with their actual status has been found, or if their designation does not correspond to that decree, if the germ products from a third country listed and published by the Commission or from a collection centre approved for the export of those products to the European Union do not come under the law.
(3) The acceptance of a consignment of germ products may be refused in accordance with Article 34 (1) of the Act if the verification of the documents accompanying the consignment shows that the trading requirements or the conditions for their importation have not been complied with.
(4) If the Regional Veterinary Administration decides to refuse the consignment of germ products and if the country of collection does not agree within 30 days, in the case of fresh germ products immediately, with the return of the consignment, the Regional Veterinary Administration
(a) order the destruction of germ products in accordance with Articles 49 (1) (d) and 54 (1) of the Act;
(b) inform the consignor or his representative of the measure and its reasons.
(1) Where a disease is present or spreads within the territory of a third country which may be transmitted by germinal products and could endanger animal health in the Czech Republic, or where any other reason relating to animal health so requires, the competent authority shall, in accordance with the law, take appropriate measures, in particular prohibit the importation of germ products from or part of the third country concerned. In accordance with Section 48 (1) (o) (2) of the Act, the Central Veterinary Administration shall inform the Commission and the Member States of these measures and of the reasons for their adoption.
(2) It shall be irrelevant for the procedure referred to in paragraph 1 whether germ products are imported from a third country into the Czech Republic directly or indirectly through another Member State.
The entry into the Czech Republic of germ products referred to in Section 14 which have passed through the territory of a third country may be subject to the presentation of a health certificate confirming their compliance with the requirements of this Decree. Application of this procedure requires the Central Veterinary Administration to inform the Commission and the Member States in advance.
(1) The organisation and method of carrying out veterinary checks on germ products intended for trade or import from third countries and the measures resulting from the results of such checks are governed by specific legislation. 5)
(2) Where the Commission carries out on-the-spot veterinary checks by its experts in the Czech Republic or in a third country in order to ensure uniform application of European Union rules on animal health requirements for trade in germ products and the animal health conditions for their importation from third countries, the State Veterinary Administration provides it with the necessary synergies, in particular through the necessary assistance and participation of veterinary experts of the Czech Republic in such inspections.
The trade in and imports from third countries of germ products intended for zoos is also subject to specific requirements laid down by Commission legal acts.
Efficacy
This decree shall take effect on the date of entry into force of the Treaty of Accession of the Czech Republic to the European Union, with the exception of Sections 4, 7, 10, 13 and 22, which shall take effect on the date of its publication.
Minister:
Ing. Palas v. r.
Příloha č. 1
Annex No 1 to Decree No 380 / 2003 Coll.
CONDITIONS FOR THE APPROVAL OF INSEMINATION STANDS AND BANKS OF SPERMAT FROM VETERINARY ASSETS AND SUPERVISORY INSURANCE IN THEM
A
Conditions for approval of semen collection centre and bank
The semen collection centre shall:
(a) be under the constant supervision of the veterinarian of the semen collection centre approved by the Regional Veterinary Administration;
(b) have at least:
(i) stables allowing housing and quarantine of animals;
(ii) semen collection facilities, including separate rooms intended for cleaning, disinfection or sterilisation of equipment;
(iii) semen treatment rooms which are not necessarily located in the same place;
(iv) semen storage rooms which are not necessarily located in the same place;
(c) be designed or isolated in such a way that there is no external contact with animals;
(d) be designed in such a way that the establishment and storage facilities for the collection, treatment and storage of semen are easy to clean and disinfect;
(e) have a quarantine stable which must not communicate directly with normal operations;
(f) be so designed that the establishment areas are physically separated from the semen treatment room and that both of those areas are separated from the semen storage room.
The semen bank must be:
(a) under the permanent supervision of the veterinarian of a bank of semen approved by the Regional Veterinary Administration;
(b) designed or isolated in such a way as to prevent contact with animals from the outside;
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Regulation Information
| Citation | Decree No 380 / 2003 Coll., on animal health requirements governing trade in semen, ova and embryos and on animal health conditions governing their importation from third countries |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 10.11.2003 |
|---|---|
| Effective from | 01.05.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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