2004D0410 — EN — 01.05.2004 — 000.002

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►B ▼C1 COMMISSION DECISION of 28 April 2004 concerning specific animal health conditions for importation of certain animals from Saint Pierre and Miquelon and amending Council Decision 79/542/EEC (notified under document number C(2004) 1548) (Text with EEA relevance) (2004/410/EC) ▼B (OJ L 151 30.4.2004, p. 29)





Corrected by:









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COMMISSION DECISION

of 28 April 2004

concerning specific animal health conditions for importation of certain animals from Saint Pierre and Miquelon and amending Council Decision 79/542/EEC

(notified under document number C(2004) 1548)

(Text with EEA relevance)

(2004/410/EC)







THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat from third countries ( 1 ), and in particular, Article 6(3) thereof, Having regard to Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(I) to Directive 90/425/EEC ( 2 ), and in particular Article 17 paragraph (3), 18(1) and 19 thereof, Whereas: (1) Council Directive 92/65/EEC establishes that the import of ungulate animals of species other than those referred to in Directives 64/432/EEC ( 3 ), 90/426/EEC ( 4 ) and 91/68/EEC ( 5 ) shall be allowed only from those third countries included in a list drawn up in accordance with its Article 17. (2) Council Decision 79/542/EEC ( 6 ) draws up a list of third countries from which the Member States authorise imports of certain live animals, lays down the specific animal and public health and veterinary certification conditions for the import of these animals, and provides for a residency period in the exporting country of more than six months. (3) Following a Commission veterinary inspection in Saint Pierre and Miquelon, the animal health situation appears to be under the satisfactory control of the official veterinary services and, in particular, the availability of a quarantine station allows the safe import into Saint Pierre and Miquelon of certain animals. (4) The facilities of the quarantine station in Saint Pierre and Miquelon allow for the residence of certain kind of ungulate animals of species other than those referred to in Directives 64/432/EEC, 90/426/EEC and 91/68/EEC. (5) Therefore it is appropriate to lay down the list of animal species and the specific animal health and certification conditions for imports of live animals in accordance with the animal health situation of Saint Pierre and Miquelon. (6) Decision 79/542/EEC should therefore be amended to allow imports of animals of species referred to in Directives 72/462/EEC and 92/65/EEC and in particular camelidae from Saint Pierre and Miquelon, and to lay down the necessary conditions. (7) On 1 May 2004 the 10 Acceding States are due to become full members of the European Community and Community rules will be applicable to them. Following their accession, these countries will than become part of the internal market and they should then be deleted from the list of third countries laid down in Decision 79/542/EEC (8) The restrictions for Bulgaria concerning the import into the Community of live bovine ovine and caprine animals in relation to bluetongue have been lifted by Commission Decision 2003/845/EC ( 7 ). (9) The list of third countries and regions laid down in Decision 79/542/EEC should be amended accordingly. (10) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health. Whereas: HAS ADOPTED THIS DECISION:







Article 1

Annex I to Decision 79/542/EEC is amended as follows:

1. the list of third countries in Part 1 is replaced by the list in Annex I to this Decision.

2. Part 2 is amended as follow: (a) in the list of ‘Models’, the following entry is added at the end: ‘CAM: Model of specific attestation for animals imported from St Pierre et Miquelon under the conditions provided for in Part 4 of Annex I.’ (b) The ‘Model RUM’ is replaced by the model in Annex II to this Decision. (c) The model of specific attestation in Annex III to this Decision is added after the model ‘SUI’.

3. the text in Annex IV to this Decision is inserted as Part 4.

Article 2

This Decision shall apply from 1 May 2004.

Article 3

This Decision is addressed to the Member States.









ANNEX I









’ANNEX I

LIVE ANIMALS

Part 1







List of third countries or parts thereof (1) Country Code of Territory Description of territory Veterinary certificate Specific conditions Model(s) SG 1 2 3 4 5 6 BG- Bulgaria BG-0 Whole country - VI BG-1 The provinces of Varna, Dobrich, Silistra, Choumen, Targovitchte, Razgrad, Rousse, V.Tarnovo, Gabrovo, Pleven, Lovetch, Plovdic, Smolian, Pasardjik, Sofia distric, Sofia city, Pernik, Kustendil, Blagoevgrad, Sliven, Starazagora, Vratza, Montana and Vidin BOV-X, BOV-Y, RUM, OVI-X, OVI-Y A CA - Canada CA-0 Whole country POR-X IVb IX CA-1 Whole country except the Okanagan Valley region of British Columbia described as follows: — From a point on the Canada/United States border 120o 15' longitude, 49o latitude; — Northerly to a point 119o 35' longitude, 50o 30' latitude; — North-easterly to a point 119o longitude, 50o 45' latitude; Southerly to a point on the Canada/United States border 118o 15' longitude, 49o latitude BOV-X, OVI-X, OVI-Y A CH - Switzerland CH-0 Whole country BOV-X, BOV-Y, OVI-X, OVI-Y, RUM POR-X, POR-Y, SUI B CL - Chile CL-0 Whole country OVI-X, RUM POR-X, SUI B CY – Cyprus (2) CY- Whole country POR-X, POR-Y B CZ - Czech Republic (2) CZ-0 Whole country BOV-X, BOV-Y,RUM, OVI-X, OVI-Y POR-X, POR-Y IVa V EE - Estonia (2) EE-0 Whole country BOV-X, BOV-Y, RUM, OVI-Y GL - Greenland GL-0 Whole country OVI-X, RUM V HR - Croatia HR-0 Whole country BOV-X, BOV-Y, RUM, OVI-X, OVI-Y HU - Hungary (2) HU-0 Whole country BOV-X, BOV-Y, RUM, OVI-X, OVI-Y V POR-X, POR-Y B IS - Iceland IS-0 Whole country BOV-X, BOV-Y, RUM, OVI-X, OVI-Y I POR-X, POR-Y B LT - Lithuania (2) LT-0 Whole country BOV-X, BOV-Y, OVI-Y, RUM LV - Latvia (2) LV-0 Whole country BOV-X, BOV-Y, OVI-Y, RUM MT - Malta (2) MT-0 Whole country RUM, OVI-X, OVI-Y NZ - New Zealand NZ-0 Whole country BOV-X, BOV-Y, RUM, POR-X, POR-Y, OVI-X, OVI-Y I PL - Poland (2) PL-0 Whole country BOV-X, BOV-Y, RUM, OVI-X, OVI-Y PM - St Pierre Miquelon PM-0 Whole country BOV-X, BOV-Y, RUM, OVI-X, OVI-Y CAM RO - Romania RO-0 Whole country BOV-X, BOV-Y, RUM, OVI-X, OVI-Y V SI – Slovenia (2) SI-0 Whole country BOV-X, BOV-Y, RUM, OVI-Y SK – Slovakia (2) SK-0 Whole country BOV-X, BOV-Y, RUM, OVI-X, OVI-Y V (1) Without prejudice to specific certification requirements provided for by any relevant Community agreement with third countries. (2) Only applicable until this Acceding State becomes a Member State of the Community.’

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Specific conditions (see footnotes in each certificate):

‘I’ : territory where the presence of BSE in native cattle has been assessed as highly unlikely, for the purpose of exporting to the European Community animals certified according to the models of certificate BOV-X and BOV-Y.

‘II’ : territory recognised as having an official tuberculosis-free status for the purposes of exports to the European Community of animals certified according to the model of certificate BOV-X.

‘III’ : territory recognised as having an official brucelliosis-free status for the purposes of exports to the European Community of animals certified according to the model of certificate BOV-X.

‘IVa’ : territory recognised as having an official enzootic-bovine-leukosis (EBL) free status for the purposes of exports to the European Community of animals certified according to the model of certificate BOV-X.

‘IVb’ : territory with approved holdings recognised as having an official enzootic-bovine-leukosis (EBL) free status for the purposes of exports to the European Community of animals certified according to the model of certificate BOV-X.

‘V’ : territory recognised as having an official brucellosis-free status for the purposes of exports to the European Community of animals certified according to the model of certificate OVI-X.

‘VI’ : Geographical constraints:

‘VII’ : territory recognised as having an official tuberculosis-free status for the purposes of exports to the European Community of animals certified according to the model of certificate RUM.

‘VIII’ : territory recognised as having an official brucellosis-free status for the purposes of exports to the European Community of animals certified according to the model of certificate RUM.

‘IX’ : territory recognised as having an official Aujeszky’s disease-free status for the purposes of exports to the European Community of animals certified according to the model of certificate POR-X.

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ANNEX II

►(1) C2

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ANNEX III









ANNEX IV

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‘Part 4

Animal species

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Taxon ORDER FAMILY GENUS AND SPECIES Artiodactila Camelidae Camelus ssp., Lama ssp., Vicugna ssp.

Animal species

Animal health conditions

Import and quarantine conditions for animals imported into St. Pierre and Miquelon within a period of less than six months prior to export to the European Community

Chapter 1

Residence and quarantine

1. Animals imported into St Pierre and Miquelon must reside in an authorised quarantine station for a minimum period of 60 days preceding export to the European Community. This period may be increased due to testing requirements for individual species. In addition the animals must comply with the following requirements: (a) Separate consignments may enter the quarantine station. However, upon entry in the quarantine station all animals of the same species should be considered as a single group, and referred to as such. The quarantine period would commence for the whole group at the point that the last animal entered the facility. (b) Within the quarantine station each specific group of animals must be maintained in isolation, with no direct or indirect contact with any other animals, including those from other consignments that may be present. Each consignment must be kept in the approved quarantine station and protected from vector insects. (c) If, during the period of quarantine, the isolation of a group of animals is not maintained and contact is made with other animals, the quarantine is considered null and void, and the group must begin a new period of quarantine of the same time period as initially prescribed on entry into the quarantine station. (d) animals to be exported to the European Community which pass through the quarantine station must be loaded and dispatched directly to the European Community: (i) without coming into contact with animals other than animals which fulfil the health conditions established for the importation of the relevant category of animal into the European Community; (ii) segregated into consignments so that no consignment can came in contact with animals not eligible for importation into the European Community; (iii) in transport vehicles or containers which have first been cleansed and disinfected with a disinfectant officially authorized in St. Pierre and Miquelon as effective in the control of the diseases mentioned in Chapter II below and which are so constructed that faeces, urine, litter or fodder cannot flow or fall out of the vehicle during transportation.

2. The quarantine premises must at least meet the minimum standards laid down in Annex B to Directive 91/496/EEC, and the following conditions: (a) they shall be supervised by an official veterinarian. (b) they shall be situated at the centre of an area 20 km in diameter in which, according to official findings, for at least 30 days prior to their use as quarantine station there has been no case of foot-and-mouth disease. (c) they shall, before being used as quarantine station, be cleansed and disinfected with a disinfectant officially authorized in St Pierre et Miquelon as effective in the control of the diseases mentioned in Chapter II. (d) they shall operate, taking into account their animal capacity: (i) a facility dedicated exclusively for this purpose, including adequate housing to a suitable standard for the animals; (ii) appropriate facilities, that — are easy to completely clean and disinfect, — include facilities for safe loading and unloading, — are able to fulfil all watering and feeding requirements for the animals, — allow any necessary veterinary treatment to be easily administered; (iii) appropriate facilities for inspection and isolation; (iv) appropriate equipment for cleaning and disinfecting rooms and transport vehicles; (v) an appropriate storage area for fodder, litter and manure; (vi) an appropriate system for collecting waste water; (vii) an office for the official veterinarian. (e) when operating, they shall have sufficient veterinarians to carry out all duties, (f) they shall only admit animals that are individually identified so as to guarantee traceability. To this end, when animals are admitted the owner or person in charge of the quarantine station shall ensure the animals are properly identified and accompanied by health documents or certificates for the species and categories involved. Moreover, this person shall record on a register or a data base, and retain for at least 3 years, the name of the owner, the origin, date of entry and exit, number and identification of the animals and their destination, (g) the competent authority shall determine the procedure for official supervision of the quarantine station and shall ensure that such supervision is carried out; this supervision shall include regular inspections in order to ascertain that the requirements for approval continue to be fulfilled. In case of failure and suspension, the approval may only be restored when the competent authority is satisfied that the quarantine premises are in full compliance with all the provisions mentioned above.

Chapter 2

Animal health tests

1. General requirements

The animals must be subjected to the following tests carried out on samples of blood taken, if not specified otherwise, not earlier than 21 days after the commencing of the isolation period. The laboratory tests must be carried out in an approved laboratory in the European Community and all laboratory test and their results, vaccinations and treatments must be enclosed with the health certificate. In order to keep animal interventions to a minimum, sampling, tests and any vaccinations must be grouped as far as is possible whilst respecting the minimum time intervals required by the testing protocols.

2. Specific requirements

2.1. Camelids

2.1.1. Tuberculosis

(a) Test to be used: comparative intradermal reaction test using Bovine PPD and Avian PPD conforming to the standards for the manufacture of bovine and avian tuberculins as described in Annex B of Council Directive 64/432/EEC. The test has to be executed in the area behind the shoulder (axillary region) following the technique described in Annex B of Council Directive 64/432/EEC.

(b) Timing: the animals have to be tested within two days from their arrival in the quarantine station and after 42 days from the first test.

(c) Interpretation of tests: the reaction has to be considered: — negative if the increased skin thickness is less than 2 mm, — positive if the increased skin thickness is more than 4 mm, — inconclusive if the increased skin thickness to the bovine PPD is between 2mm and 4 mm, or more than 4 mm but less then the reaction to the avian PPD.

(d) Options for action following testing: If an animal presents a positive result to the intradermal-reaction to the bovine PPD, this animal shall be excluded from the group and the other animals have to be re-tested starting at least 42 days after the first positive test was administered: this has to be considered as the first test described in b). If more than one animal of the group presents a positive result, the whole group shall to be rejected for exportation to the EC. If one or more animals of the same group present an inconclusive reaction, the whole group will be re-tested after 42 days considering it as the first test described in b).

2.1.2. Brucellosis.

(a) Test to be used: — B. Abortus: SAT and RBT as described respectively in point 2.6 and (2.5) in Annex C to Directive 64/432/EEC. In case of positive result, a Complement fixation test has to be performed for confirmation. — B. Melitensis: SAT and RBT as described respectively in point 2.6 and 2.5 in Annex C to Directive 64/432/EEC. In case of positive result, a Complement fixation test following the method described in Annex C to Directive 91/68/EC has to be performed for confirmation. — B. Ovis: Complement fixation test as described in Annex D to Directive 91/68/EC

(b) Timing: the animals have to be tested within two days from their arrival in the quarantine station and after 42 days from the first test.

(c) Interpretation of tests: A positive reaction to the tests will be as defined in Annex C to Directive 64/432/EEC.

(d) Options for action following testing: Animals tested positive to one of the tests shall be excluded from the group and the other animals have to be re-tested starting at least 42 days after the first positive test was performed: this has to be considered as the first test described in (b). Only the animals that tested negative to two consecutive tests performed as described in (b) shall be allowed for exportation to the EC.

2.1.3. Bluetongue and epizootic haemorrhagic disease (EHD).

(a) Test to be used: AGID test as described in Part 3 (C) of Annex I to Council Decision 79/542/EEC. In case of positive reaction the animals have to be tested with Competitive ELISA test as described in Part 3(C) of Annex I to Council Decision 79/542/EEC to discriminate between the two diseases.

(b) Timing: The animals have to be tested with negative result to two tests: the first within two days from their arrival in the quarantine station and the second after at least 21 days from the first test.

(c) Options for action following testing: (i) Bluetongue If one or more animals tested positive to the ELISA as described in Part 3 (C) of Annex I to Decision 79/542/EEC, the positive animal/animals shall be excluded from the group, and the whole remaining group will be quarantined for 100 days starting from the date in which the samples for the positive test were collected. The group can only be considered free of disease if regular checks by official veterinarians through the duration of the quarantine period fail to reveal clinical symptoms of disease, and the quarantine station remains free of Blue Tongue vectors (Culicoides). If a further animal presents clinical symptoms of disease during the quarantine period as described above, the whole group shall be rejected for exportation to the EC. (ii) Epizootic haemorrhagic disease (EHD). If one or more animals tested positive reveals presence of antibodies to the EHD virus during confirmatory ELISA testing, the animal(s) shall be considered positive and shall be excluded from the group, and the whole group must be subject to repeat testing beginning at least 21 days after the initial positive diagnosis and again at least 21 days subsequently, both with negative results. If any additional animals are tested positive during repeat testing, the whole group shall be rejected for exportation to the EC.

2.1.4. Foot-and-mouth disease (FMD)

(a) Test to be used: Diagnostic tests (probang and serology) using ELISA and NV techniques under the protocols described in Part 3 (C) of Annex I to Decision 79/542/EEC.

(b) Timing: the animals have to be tested with negative results to two tests: the first within two days from their arrival in the quarantine station and the second after at least 42 days from the first test.

(c) Options for action following testing: If any animal tests positive for FMD virus, then all animals present in the quarantine station are not considered eligible for entry into the EC. Note: Any detection of antibodies to structural or not structural proteins of FMD virus will be considered as a result of previous infection of FMD irrespective of the vaccination status.

2.1.5. Rinderpest

(a) Test to be used: The competitive ELISA test as described in the OIE manual is the prescribed test for international trade and is test of choice. Serum neutralisation test, or other recognised tests in accordance with the protocols described in relevant sections of the OIE manual can also be used.

(b) Timing: the animals have to be tested twice: the first within two days from their arrival in the quarantine station and the second after at least 42 days from the first test.

(c) Options for action following testing: If any animal tests positive for Rinderpest virus, then all animals present in the quarantine station are not considered eligible for entry into the EC.

2.1.6. Vesicular stomatitis

(a) Test to be used: ELISA, virus neutralisation test, or other recognised test in accordance with the protocols described in relevant sections of the OIE manual.

(b) Timing: the animals have to be tested twice: the first within two days from their arrival in the quarantine station and the second after at least 42 days from the first test.

(c) Options for action following testing: If any animal tests positive for Vesicular Stomatitis virus, then all animals present in the quarantine station are not considered eligible for entry into the EC.

2.1.7. Rift Valley Fever

(a) Test to be used: ELISA, virus neutralisation test, or other recognised test in accordance with the protocols described in relevant sections of the OIE manual.

(b) Timing: the animals have to be tested twice: the first within two days from their arrival in the quarantine station and the second after at least 42 days from the first test.

(c) Options for action following testing: If any animal displays evidence of exposure to Rift Valley Fever agent, then all animals present in the quarantine station are not considered eligible for entry into the EC.

2.1.8. Lumpy skin disease

(a) Test to be used: Serology using ELISA, virus neutralisation test, or other recognised test in accordance with the protocols described in relevant sections of the OIE manual.

(b) Timing: the animals have to be tested twice: the first within two days from their arrival in the quarantine station and the second after at least 42 days from the first test.

(c) Options for action following testing: If any animal displays evidence of exposure to Lumpy Skin Disease, the whole group shall be rejected for exportation to the EC.

2.1.9 Crimean Congo haemorrhagic fever

(a) Test to be used: ELISA, virus neutralisation test, Immunofluorescence test or other recognised test.

(b) Timing: the animals have to be tested twice: the first within two days from their arrival in the quarantine station and the second after at least 42 days from the first test.

(c) Options for action following testing: If any animal displays evidence of exposure to Crimean Congo Haemorrhagic fever agent, then that animal shall be excluded from the group.

2.1.10. Surra (Trypanosoma evansi)

(a) Test to be used: The parasitic agent can be identified in concentrated blood samples in accordance with the protocols described in relevant sections of the OIE manual.

(b) Timing: the animals have to be tested twice: the first within two days from their arrival in the quarantine station and the second after at least 42 days from the first test.

(c) Options for action following testing: If T. evansi is detected in any animal, then that animal shall be excluded from the group. The remaining group should then undergo internal and external antiparasitic treatment using suitable agents that are effective against T. evansi.

2.1.11. Malignant catarrhal fever

(a) Test to be used: Detection of viral DNA is the preferred method, based on identification by immunofluorescence or immunocytochemistry using the protocols described in relevant sections of the OIE manual.

(b) Timing: the animals have to be tested twice: the first within two days from their arrival in the quarantine station and the second after at least 42 days from the first test.

(c) Options for action following testing: If any animal displays evidence of exposure to MCF, then the whole group shall be rejected for exportation to the EC.

2.1.12. Rabies

Vaccination: Rabies vaccination may be carried out in certain cases and the animal should be blood sampled and a serum neutralisation test for antibodies carried out.

2.1.13. Bovine leucosis. (only in the case the animals are destined to a free region)

(a) Test to be used: AGID or blocking ELISA, in accordance with the protocols described in the OIE manual.

(b) Timing: the animals have to be tested twice: the first within two days from their arrival in the quarantine station and the second after at least 42 days from the first test.

(c) Options for action following testing: animals tested positive to the test shall be excluded from the group and the other animals have to be re-tested starting at least 21 days after the first positive test was performed: this has to be considered as the first test described in (b).

Only the animals that tested negative to two consecutive tests performed as described in (b) shall be allowed for exportation to the EC.’