Decree No. 381 / 2003 Coll.
Ordinance on animal health requirements for aquaculture animals and products thereof, fishery products and live bivalve molluscs and on animal health conditions governing their importation from third countries
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Order
Effective from 01.05.2004
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381
DECLARATION
of 3 November 2003
on animal health requirements for aquaculture animals and products thereof, fishery products and live bivalve molluscs and the animal health conditions governing their importation from third countries
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 5 (3), 8 (5), 10 (3), 22 (2), 24 (2), 27 (4), 28 (5), 31 (3), 34 (5), 37 (5), 38 (4) and 38b (2) of the Act:
Preliminary provisions
Subject matter
(1) This decree, in accordance with the law of the European Communities (1), regulates:
(a) the animal health requirements for the production and placing into circulation of aquaculture animals and products of aquaculture in the territory of the Member States of the European Union (hereinafter referred to as "the Member State");
(b) animal health conditions for imports of aquaculture animals and products thereof from countries which are not Member States ("third countries"),
(c) a list of diseases for which, and according to what aspects, a programme for the recovery of aquaculture animals can be drawn up as referred to in the recognition of holdings, zones or states as disease-free and in the context of which specific animal health guarantees apply to trade in aquaculture animals and aquaculture products with Member States (hereinafter referred to as "trade"),
(d) certain animal health conditions governing the transport of aquaculture animals and products;
(e) the period within which the veterinary certificate on the basis of which it is issued may be applied for and the period of validity of the certificate.
(2) This decree is without prejudice to the requirements laid down in specific legislation2) for the protection of individual species of animals referred to in paragraph 1.
(3) In the case of aquaculture animals and products thereof which are genetically modified organisms, this decree shall not affect the requirements laid down in specific legislation.3)
Definition of terms
For the purposes of this decree:
(a) aquaculture animals - live fish, crustaceans and molluscs, coming from holdings, including wild animals and intended for farming;
(b) fish, crustaceans and molluscs - any fish, crustaceans or molluscs at any stage of development;
(c) aquaculture products - products derived from aquaculture animals which are intended either for breeding - such as sex cells or for human consumption;
(d) approved (continental) zone (s) - zone (s) which satisfies the conditions of the part And Annex 2 to this Order,
(e) approved (continental) holdings - holdings which fulfil the conditions of Part B of Annex 2 to this Regulation,
(f) holdings - any undertaking or geographically defined establishment in which aquaculture animals are kept or kept for the purpose of putting them into circulation;
(g) an approved laboratory - the relevant national reference laboratory or the relevant reference laboratory, or a laboratory which has been issued for the relevant examination course of the accreditation certificate and which has been authorised by the State Veterinary Administration to carry out veterinary laboratory diagnostic activities;
(h) the competent authority - the central authority of the Member State authorised to carry out veterinary checks or another authority of the Member State to which that authority has been delegated.
Veterinary requirements for aquaculture animals and products intended for trade
Aquaculture animals and products
(1) Aquaculture animals may not enter into circulation in the territory of the Member States (hereinafter referred to as "Community territory"):
(a) show no clinical signs of disease on the day of loading,
(b) be intended for killing or slaughter in the context of exceptional veterinary measures laid down in accordance with the law and special legislation4) to control and combat one of the diseases listed in Annex 1 thereto;
(c) come from a holding which is subject to prohibited or restrictive animal health measures ordered or declared in accordance with the law and special legislation4) to control and control a disease, in particular fish diseases, or to come into contact with animals coming from such a holding.
(2) Aquaculture products may be put into circulation in the Community territory
(a) for breeding purposes (sex cells) if they come from animals which satisfy the requirements referred to in paragraph 1;
(b) for human consumption if they come from animals which comply with the requirement referred to in paragraph 1 (a).
(1) Aquaculture animals must be dispatched as quickly as possible to their destination by means of means of transport which have been cleaned in advance and disinfected, as appropriate, with disinfectants approved under law or specific legislation. 5)
(2) Where water is used for the transport of aquaculture animals by land, the means of transport shall be so designed that water cannot flow from it during transport.
(3) Transport must be carried out in such a way as to ensure the effective protection of the health and well-being of transported aquaculture animals, in particular by the exchange of water. This exchange shall be carried out in establishments approved by the Regional Veterinary Administration where, in order to avoid the risk of contamination of the environment at the place of destination, the water is either disinfected or under no circumstances released directly into the sea or into the waterways.
(4) The water used for the exchange referred to in paragraph 3 must have health characteristics such as to avoid endangering the health of the species of aquaculture animals transported, in particular with regard to the disease agents listed in column 1 of list II of Annex 1 to this Regulation.
(5) The State Veterinary Administration shall submit a list of approved places where the water exchange referred to in paragraph 3 is carried out to the Commission of the European Community (hereinafter referred to as the Commission).
(1) When assessing whether the animal health requirements for aquaculture animals and products of aquaculture animals traded are met, account should be taken of the conditions of their destination, in particular whether those animals or products are intended for an approved zone or an approved holding.
(2) In the application for the status of an approved (continental) zone with regard to one or more of the diseases listed in column 1 of List II of Annex 1 to this Regulation, submitted to the Commission, it is appropriate to specify:
(a) any grounds relating to compliance with the conditions laid down for that zone;
(b) legislation ensuring compliance with the conditions referred to in (a).
(3) In the application for the status of an approved (continental) holding in a non-approved zone with regard to one or more of the diseases listed in column 1 of list II of Annex 1 to this Regulation, submitted to the Commission, it is appropriate to indicate:
(a) any grounds relating to compliance with the conditions laid down for that holding;
(b) legislation ensuring compliance with the conditions referred to in (a).
(1) Live fish belonging to species susceptible to viral haemorrhagic septicaemia and infectious haematopoietic necrosis listed in column 2 of list II of Annex 1 to this Regulation and to their sex cells must be accompanied by a transport document issued by an official veterinarian on a form issued by the State Veterinary Administration in accordance with the model of this document provided for in these cases by the Commission (hereinafter referred to as "the form corresponding to the model laid down therein") certifying that they originate:
(a) from an approved zone or an approved holding if they are intended for an approved zone;
(b) from an approved zone or an approved holding having the same health status as the holding of destination, provided that it is intended for a holding which, although not in the approved zone, fulfils the conditions laid down for the approved holding.
(2) Live molluscs belonging to species susceptible to bonamiosis and marteiliosis listed in column 2 of list II of Annex No 1 to this Regulation must be accompanied by a transport document drawn up by an official veterinarian on a form conforming to a model established to certify that they originate in:
(a) from an approved coastal zone or from an approved farm in a non-approved coastal zone, where they are intended for relaying in an approved coastal zone;
(b) from an approved coastal zone or from a holding of the same health status as that of the holding of destination, if it is intended for relaying on a holding which, although not in an approved coastal zone, fulfils the conditions laid down for an approved holding.
(1) The placing into circulation in the approved zone of aquaculture animals and products thereof originating in a non-approved zone and intended for human consumption shall comply with the following requirements:
(a) fish susceptible to the diseases listed in column 1 of List II of Annex 1 to this Regulation shall be killed and eviscerated before dispatch; evisceration is not required if the fish come from an approved holding in a non-approved zone,
(b) live molluscs susceptible to the diseases listed in column 1 of list II of Annex 1 to this Regulation shall be supplied either directly for human consumption or for the preservation industry; they may be relayed only if they come from an approved farm in a non-approved coastal zone or are temporarily located in storage tanks or purification centres [§ 24 (1) (b)] which are specially equipped and approved by the Regional Veterinary Administration for this purpose and which have in particular adequate facilities for treatment and disinfection of waste water.
(1) Each consignment of aquaculture animals and products thereof must be:
(a) be accompanied to the place of destination by an original duly completed transport document drawn up on a form corresponding to the model laid down;
(b) marked in such a way that the holding of origin from which the animals and products originate can be traced at any time and that it can be verified that they correspond to the information contained in the transport document. The particulars relating to the marking of the consignment may also appear directly on the container or on the label attached to the container.
(2) The transport document shall certify the origin of aquaculture animals or products of aquaculture animals and compliance with the requirements laid down in this Decree and, where appropriate, the specific animal health guarantees which may be required at the place of destination.
(3) The transport document shall be issued by the official veterinarian at the place of origin no more than 48 hours before loading on the basis of an inspection of aquaculture animals or products of aquaculture, in at least one of the official languages of the place of destination. The transport document shall be drawn up on a single sheet, intended for one consignee and stamped and signed by an official veterinarian in a colour different from that of the other text. The transport document shall be valid for 10 days.
(1) Where a programme is drawn up by the State Veterinary Administration to enable the procedure referred to in Article 5 (2) or (3) to be initiated, it shall be indicated:
(a) the zone and holdings concerned by the programme;
(b) the measures to be taken by the veterinary authorities to ensure the implementation of the programme;
(c) the approved laboratories, their number, location and testing procedures (methods) governing them;
(d) the prevailing diseases listed in column 1 of lists I and II of Annex No 1 thereto;
(e) the measures taken in the event of such diseases.
(2) In accordance with Section 48 (1) (o) (2) of the Act, the State Veterinary Administration shall submit a programme drawn up for approval to the Commission.
(3) Paragraphs 1 and 2 shall apply mutatis mutandis for the amendment or addition of an approved programme.
(1) Where the grounds for recognition of the territory of the Czech Republic or a part thereof are given as being free from one of the diseases listed in column 1 of list III of Annex 1 to this Regulation, the State Veterinary Administration shall, in accordance with Section 48 (1) (o) (2) of the Act, request the Commission to define such a territory as free of disease and animal species considered susceptible to that disease as well as to establish specific animal health guarantees which may be required for the introduction of aquaculture animals and products thereof.
(2) The application referred to in paragraph 1 shall state:
(a) the identification of the disease and its previous occurrence in the Czech Republic;
(b) the results of an epidemiological inquiry based on serological, virological, microbiological, pathological, anatomical or parasitological investigations and on the fact that the disease is subject to reporting within a system of veterinary authorities;
(c) the period during which the investigation was carried out;
(d) a system of veterinary checks verifying that the relevant territory remains free of disease.
(3) The State Veterinary Administration shall inform the Commission of any change in the particulars referred to in paragraph 2.
(4) Live fish, aquatic crustaceans and bivalve molluscs and, where appropriate, their sex cells must be accompanied by a transport document drawn up on a form corresponding to the model laid down when entering a territory recognised as disease-free; the transport document certifies compliance with the specific animal health guarantees referred to in paragraph 1.
(1) Where a programme is adopted for the recovery of aquaculture animals from one of the diseases listed in column 1 of list III of Annex No 1 to this Regulation, on the basis of which specific animal health guarantees for the entry of aquaculture animals and products of aquaculture into veterinary controlled zones and holdings may be required, the State Veterinary Administration shall, in accordance with Article 48 (1) (o) (2) of the Act, request the Commission to approve and establish those guarantees.
(2) The application referred to in paragraph 1 shall state:
(a) the spread of the disease in the Czech Republic;
(b) the justification of the programme, taking into account the importance of the disease, its expected benefit and the likely cost of its implementation;
(c) the geographical area in which the programme will be implemented;
(d) establishing the status of the holding and the standards to be complied with by the holding in each category, including methods of investigation;
(e) the conditions for the entry into those holdings of animals of lower health status;
(f) measures in cases where the holding loses its status for any reason;
(g) means of monitoring the implementation of the programme.
(3) Paragraphs 1 and 2 shall apply mutatis mutandis for the amendment or addition of an approved programme.
(1) Live breeding fish not belonging to species susceptible to the diseases listed in column 2 of list II of Annex 1 to this Regulation and their sex cells may be put into circulation
(a) to an approved zone, provided that they are accompanied by a transport document certifying that they come from a zone with the same health status, from an approved holding situated outside the approved zone, or from a holding situated outside the approved zone, provided that there are no fish on that holding belonging to susceptible species listed in column 2 of list II of Annex No 1 to this Regulation and that that holding is not associated with water flow, coastal waters or water mouth;
(b) a holding which, even if situated in a non-approved zone, complies with the conditions laid down in Part B of Annex 2 to this Regulation for the approval of a holding in a non-approved zone, provided that it is accompanied by a transport document certifying that it comes from an approved zone, from a holding with the same health status or from a holding situated outside the approved zone, provided that there are no fish on that holding belonging to the susceptible species listed in column 2 of list II of Annex 1 to this Regulation and that that that holding is not associated with water flow, coastal waters or water estuary.
(2) The provisions of paragraph 1 shall be without prejudice to the requirements relating to the diseases listed in column 1 of Part III of Annex 1 to this Regulation, established in accordance with Sections 10 and 11.
(3) For farmed molluscs not belonging to susceptible species listed in column 2 of List II of Annex 1 to this Regulation, the provisions of paragraph 1 shall apply mutatis mutandis.
(1) Wild fish, crustaceans and molluscs and sex cells may be put into circulation
(a) to an approved zone if they are accompanied by a transport document certifying that they come from a zone with the same health status;
(b) to a holding which, even if situated in a non-approved zone, satisfies the conditions laid down in Part B of Annex 2 to this Regulation for the approval of a holding in a non-approved zone, provided that it is accompanied by a transport document certifying that it comes from an approved zone.
(2) The provisions of paragraph 1 shall be without prejudice to the requirements relating to the diseases listed in column 1 of List III of Annex 1 to this Decree, established in accordance with Sections 10 and 11.
(3) Where the animals referred to in paragraph 1 are caught in the high seas and intended for breeding in approved zones and in approved holdings, they shall be placed under national veterinary supervision in quarantine in appropriate establishments and under appropriate conditions.
(1) The requirements set out in Sections 12 and 13 shall not apply if, on the basis of experience or knowledge of science, it has been demonstrated that the movement of aquaculture animals not belonging to the susceptible species listed in column 2 of List II of Annex 1 to this Regulation, as well as their sex cells, from the non-approved zone to the approved zone does not involve passive transmission of the disease. The list of aquaculture animals covered by this provision is set out in Annex 3 to this Regulation.
(2) Paragraph 1 does not apply to ornamental tropical fish kept in aquariums.
(1) Consignments of live fish of aquaculture origin and their sex cells must be in trade:
(a) between zones not approved for the diseases listed in column 2 of list II of Annex 1 to this Regulation, accompanied by a health certificate drawn up on a form corresponding to the model laid down,
(b) other holdings infected with the same disease shall be accompanied by a health certificate drawn up on a form corresponding to the model laid down.
(2) The health certificates referred to in paragraph 1 must be:
(a) issued in at least one of the official languages of the Member State of destination;
(b) made out on a single sheet,
(c) intended for one beneficiary;
(d) attached to the consignment in the original.
(1) Live fish, crustaceans and molluscs not belonging to susceptible species listed in column 2 of List II of Annex 1 to this Regulation, as well as their sex cells, intended for the market, breeding, breeding, further growth, fattening or re-introduction into approved zones and approved farms, must be accompanied by the transport document referred to in Annex 4 to this Regulation until their destination.
(2) The transport document referred to in paragraph 1 shall be drawn up by the official veterinarian on the day of loading in at least one of the official languages of the Member State of destination on a single sheet. However, if this is not possible and if the transport document is made out on multiple sheets, these sheets shall be suitably joined and marked to form an integral whole (for example, by the following numbering of the pages: page number of the total number of pages).
(3) The transport document referred to in paragraph 1 shall bear the serial number and the stamp and signature of the official veterinarian in a colour different from that of the other text. The period of validity of the transport document shall be 10 days from the date of issue; in the case of ship transport, this period is extended by the time spent on the ship.
(4) Aquaculture animals and their sex cells are not transported together with other aquaculture animals and their sex cells, which have a lower health status, or under other conditions which could undermine their health status.
(1) The requirements for drawing up sampling plans and diagnostic procedures for the detection and confirmation of viral haemorrhagic septicaemia (VHS) and infectious haematopoietic necrosis (IHN) are set out in Annex 5 to this Regulation.
(2) Sampling plans must take into account the presence of wild fish, crustaceans and molluscs in the aquatic environment.
(3) In justified cases, the laboratory may modify the tests referred to in Annex 5 to this Regulation or use different tests if equivalent sensitivity and specificity can be demonstrated.
(4) Sampling plans and diagnostic procedures for the detection and confirmation of Bonamia ostreae and Marteilia refringens, applied in the event of exceptional shellfish mortality and for the examination of approved zones and holdings, are governed by the "Diagnostic Manual of Aquatic Animal Diseases" of the International Office of Animal Disease (OIE), third edition 2000, Part 3 - mollusc disease.
Animal health conditions for imports from third countries of aquaculture animals and products
(1) Aquaculture animals and products may be imported
(a) from third countries or parts thereof appearing on the list of third countries and parts thereof drawn up, published and published by the Commission;
(b) under the conditions laid down for each third country by the Commission and, where import conditions have not been so established, under conditions at least equivalent to those applicable to the production and marketing of aquaculture animals and products in the Community.
(2) The conditions referred to in paragraph 1 (b) may, depending on the disease situation of the third country concerned, relate in particular to restrictions on imports from a third country or part thereof, restrictions on imports of certain types of aquaculture animals and aquaculture products at any stage of development, treatment or use of such animals or products, or measures to be taken after importation of such animals or products (quarantine, disinfection, etc.).
Veterinary certificate for export of aquaculture animals and products
The issue of a veterinary certificate for the export of aquaculture animals and products thereof shall be requested to the competent authority within a period of at least the following time limits:
(a) 2 working days before the date of their intended dispatch, if the animals and products for which health tests have been carried out in the last month before the date of their intended dispatch are necessary for the issue of this certificate, in particular due to the import conditions of the third country of destination,
(b) 14 days before the date of their intended dispatch in other cases.
(1) The animal health certificate for export of aquaculture animals and products of aquaculture shall be issued by the official veterinarian, taking into account the import conditions of the third country of destination and following an inspection (s) of the animals. This certificate must be drawn up in the Czech language and in at least one of the languages of the third country of destination on a single sheet; However, if this is not possible and the certificate is made out on several sheets, these sheets shall be suitably joined and labelled to form an integral whole. The health certificate shall be for one consignee.
(2) The health certificate referred to in paragraph 1 shall bear the stamp and signature of the official veterinarian in a colour different from that of the other text and the serial number.
(3) Unless the Regional Veterinary Administration provides otherwise in accordance with Article 49 (1) (l) of the Act, taking into account in particular the type of aquaculture animals and products of aquaculture, the method and duration of their transport shall be 10 days from the date of issue. If the Regional Veterinary Administration determines a different period of validity of the veterinary certificate, it shall indicate it in that certificate.
Common and final provisions
The organisation and method of carrying out veterinary checks on aquaculture animals and products thereof which are the subject of trade or imports from third countries, as well as the measures resulting from the results of those checks, shall be governed by specific legislation. 7)
(1) If the Commission carries out on-the-spot investigations by its experts in the Czech Republic, the State Veterinary Administration provides it with the necessary synergies and assistance in carrying out this task in accordance with Section 48 (1) (o) (2) of the Act.
(2) Where the Commission carries out on-the-spot veterinary checks by its experts in a third country in order to verify compliance with the rules of the European Communities on the importation of aquaculture animals and products from those countries, the State Veterinary Administration shall, in accordance with Article 48 (1) (o) (2) of the Act, provide it with the necessary synergies, in particular through the participation of veterinary experts of the Czech Republic in these inspections.
Efficacy
This decree shall take effect on the date of the entry into force of the Treaty of Accession of the Czech Republic to the European Union.
Minister:
Ing. Palas v. r.
Příloha č. 1
Annex No 1 to Decree No 381 / 2003 Coll.
LIST OF FISH, MOLLUSCS AND CERTAIN DISEASES
| 1 | 2 |
|---|---|
| nákaza (patogenní agens) | vnímavé druhy |
| seznam I | |
| ryby: infekční anémie lososů (ISA) | losos obecný (Salmo salar) |
| seznam II | |
| ryby: virová hemoragická septikémie (VHS) | lososovití lipan podhomí (Thymallus thymallus) síh (Coregonus sp.) štika obecná (Esox lucius) kambala (Scophtalmus maximus) |
| infekční nekróza krvetvorné tkáně(IHN) | lososovití štika obecná (Esox lucius) |
měkkýši: bonamióza (Bonamia ostreae) marteilióza (Marteilla refringens) | ústřice jedlá (Ostrea edulis) ústřice jedlá (Ostrea edulis) |
| seznam III | |
| ryby: infekční nekróza pankreatu (INP) jarní virémie kaprů (SVC) renibakterióza – BKD (Renibacterium salmonidarum) furunkulóza (Aeromonas salmonicida) yersinióza – ERM (Yersinia ruckeri) gyrodaktylóza (Gyrodactylus salaris) | Podle směrnice Rady 93/54/EHS bude upřesněno podle čl. 12 a 13. |
korýši: mor raků (Aphanomyces astaci) |
Příloha č. 2
Annex No 2 to Decree No. 381 / 2003 Coll.
FISH FISH AND FARMS APPROVED (CONTROL)
A
Continental zones for fish
(Annex No 1, column 2, list II)
(1) The Continental Zone (hereinafter referred to as "the Zone") consists of:
(a) parts of the territory which cover the whole water catchment area from the sources of the waterways to the mouth of the river, or more than one water catchment area where the fish are kept, held or hunted; or
(b) parts of the water catchment area from the sources of the waterways to the natural or artificial dam which prevent the migration of fish from the lower stream.
The size and geographical location of the zone shall be such that the possibility of recontamination, e.g. by migrating fish, is minimised. Compliance with this requirement may require the establishment of a buffer band in which monitoring programmes (monitoring) will be implemented and which will not itself have the status of an approved zone.
2. The zone may be approved if:
(a) no fish in it has for at least 4 years shown clinical or other signs of one or more of the diseases listed in Annex 1 (column 1, list II) to this decree;
(b) all holdings in the zone are under national veterinary supervision and have carried out 2 veterinary checks per year during the last 2 years. These checks shall be carried out at annual periods where the water temperature has a positive effect on the development of those diseases and shall include at least:
(aa) inspection of fish showing anomalies;
(bb) sampling according to a plan established by the Commission, the samples being sent without delay to an approved laboratory for pathogen testing that is applicable.
The zones in which, according to the records, the diseases referred to in point (a) are not present may be approved if their geographical location does not allow for the ease of introduction of the disease and where the long-term veterinary disease control system has been in operation for at least 10 years during which:
- all holdings have been monitored,
- the compulsory disease notification system has been applied and no case of disease has been reported,
- only the sex cells of fish from the disease of an unaffected zone or holding which offer equivalent animal health guarantees and are under national veterinary supervision may enter the zone.
A period of 10 years may be reduced to 5 years if the results of the examination justify this and if, in addition to meeting the above requirements, at least 2 veterinary checks have been carried out annually in the context of the monitoring of the holding, including inspection of fish showing anomalies and sampling of at least 30 fish at each control visit,
(c) where there is no holding to be approved in the zone, veterinary checks shall be carried out annually for a period of 4 years, in accordance with point (b), by fish from the downstream part of the river basin;
(d) laboratory testing of samples of fish taken during veterinary checks has ended with negative results in terms of pathogens that are considered.
If the river basin (s), starting in a neighbouring State or in a common country, are approved, both States shall apply for approval.
(3) The approval of the zone shall continue if:
(a) fish entering the zone come from another approved zone or from an approved holding;
(b) each holding passes in accordance with point 2 (b). (b) 2 veterinary checks per year with the exception of holdings without breeding animals which are checked once a year. Samples shall be taken each year alternately in 50% of all holdings in the zone,
(c) the results of laboratory analyses of samples of fish taken during veterinary checks are negative in relation to the disease agents listed in Annex 1 (column 1, list II) to this Regulation;
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Regulation Information
| Citation | Decree No 381 / 2003 Coll., on animal health requirements for aquaculture animals and products thereof, fishery products and live bivalve molluscs 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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