INFORMATION TO BE SUBMITTED BY A THIRD COUNTRY VACCINATING AGAINST AVIAN INFLUENZA

1   2   3   4   5   6   7   8   9   10   11   12   13   14   15   16   17   18   19   20   21

Annex V

(as referred to in Article 11(a))

INFORMATION TO BE SUBMITTED BY A THIRD COUNTRY VACCINATING AGAINST AVIAN INFLUENZA <*>

———————————

<*> Please give as much detailed information as necessary to allow proper assessment of the programme.

 

  1. Requirements for vaccination plans carried out in a third country, territory, zone or compartment as referred to in Article 11
  2. Country, territory, zone or compartment (keep as appropriate)
  3. Disease history (previous outbreaks in poultry or cases in wild birds of HPAI/LPAI)
  4. Description of the reasons for the decision on the introduction of vaccination
  5. Risk assessment based on:

— Avian influenza outbreak within that third country, territory, zone or compartment (keep as appropriate)

— Avian influenza outbreak in a nearby country

— Other risk factors such as certain areas, type of poultry husbandry or categories of poultry or other captive birds

  1. Geographical area where vaccination is carried out
  2. Number of establishments in vaccination area
  3. Number of establishments where vaccination is carried out, if different from number in point 6
  4. Species and categories of poultry or other captive birds in vaccination territory, zone or compartment
  5. Approximate number of poultry or other captive birds in the establishments referred to in point 7
  6. Summary of the vaccine characteristics
  7. Authorisation, handling, manufacture, storage, supply, distribution and sale of avian influenza vaccines on national territory
  8. Implementation of a DIVA strategy
  9. Envisaged duration of vaccination campaign
  10. Provisions and restrictions on the movements of vaccinated poultry and poultry products derived from vaccinated poultry or vaccinated other captive birds
  11. Clinical and laboratory tests carried out in the establishments vaccinated and/or located in the vaccination area (e.g. efficacy and pre-movement testing etc.)
  12. Means of record keeping (e.g. for the detailed information referred to point 15) and registration of holdings where vaccination is carried out.

 

  1. Surveillance for third countries, territories, zones or compartments that carry out vaccination against avian influenza as referred to in Article 11

Where vaccination is carried out in a third country, territory, zone or compartment all commercial establishments that are vaccinated against avian influenza must be required to undergo laboratory testing and the following information, in addition to the information referred to in Part I.A to Annex IV, shall be submitted:

  1. Number of vaccinated establishments in area per category
  2. Number of vaccinated establishments to be sampled per poultry category
  3. Use of sentinel birds (indicate species and number of sentinel birds used per shed)
  4. Number of samples taken per establishment and/or shed
  5. Data on vaccine efficacy.

 

Annex VI

(as referred to in Article 12(1)(b), Article 12(2)(c)(ii) and Article 13(1)(a))

CRITERIA FOR RECOGNISED NEWCASTLE DISEASE VACCINES

  1. General criteria

 

  1. Vaccines must comply with the standards set out in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (OIE) in the Chapter on Newcastle disease.
  2. Vaccines must be registered by the competent authorities of the third country concerned before being allowed to be distributed and used. For such registration, the competent authorities of the third country concerned must rely on a complete file containing data on the efficacy and innocuity of the vaccine; for imported vaccines the competent authorities may rely on data checked by the competent authorities of the country where the vaccine is produced, as far as these checks have been carried out in conformity with OIE standards.
  3. In addition, imports or production and distribution of the vaccines must be controlled by the competent authorities of the third country concerned.
  4. Before distribution is allowed, each batch of vaccines must be tested on innocuity, in particular regarding attenuation or inactivation and absence of undesired contaminating agents, and on efficacy on behalf of the competent authorities.

 

  1. Specific criteria

 

Live attenuated Newcastle disease vaccines must be prepared from a Newcastle disease virus strain for which the master seed has been tested and shown to have an intracerebral pathogenicity index (ICPI) of:

(a) less than 0,4, if not less than 107 EID50 are administered to each bird in the ICPI test; or

(b) less than 0,5, if not less than 108 EID50 are administered to each bird in the ICPI test.

 

Annex VII

(as referred to in Article 13)

ADDITIONAL HEALTH REQUIREMENTS

  1. For poultry, day-old chicks and hatching eggs coming from a third country, Territory, zone or compartment where vaccines used against Newcastle disease do not meet THE criteria of Annex VI

 

  1. Where the third country, territory, zone or compartment does not prohibit the use of Newcastle disease vaccines that do not meet the specific criteria set out in Annex VI the following additional health requirements shall apply to:

(a) poultry, including day-old chicks must not have been vaccinated with such vaccines for at least 12 months preceding the date of import to the Community;

(b) the flock or flocks must have undergone a virus isolation test for Newcastle disease not earlier than two weeks before the date of import into the Community or, in the case of hatching eggs, not earlier than two weeks before the date of collection of the eggs:

(i) carried out in an official laboratory;

(ii) on a random sample of cloacal swabs from at least 60 birds in each flock;

(iii) in which no avian paramyxoviruses with an Intracerebral Pathogenicity Index of more than 0,4 have been found.

(c) poultry must have been kept in isolation under official surveillance on the establishment of origin during the two-week period referred to in (b);

(d) poultry must not have been in contact with poultry not meeting the requirements set out in (a) and (b) during a period of 60 days before the date of import into the Community or, in the case of hatching eggs, during a period of 60 days before the date of collection of the eggs.

  1. Where day-old chicks are imported from a third country, territory, zone or compartment as referred to in point 1, the day-old chicks and the hatching eggs from which the day-old chicks are derived must not have been in contact in the hatchery or during transport with poultry or hatching eggs not meeting the requirements set out in point 1(a) to (d).

 

  1. For meat of poultry

 

Meat of poultry must come from slaughter poultry that:

(a) has not been vaccinated with live attenuated vaccines prepared from a Newcastle disease virus master seed showing a higher pathogenicity than lentogenic strains of the virus within the period of 30 days preceding slaughter;

(b) underwent a virus isolation test for Newcastle disease, carried out in an official laboratory at the time of slaughter on a random sample of cloacal swabs from at least 60 birds in each flock concerned and in which no avian paramyxoviruses with an Intracerebral Pathogenicity Index (ICPI) of more than 0,4 were found;

(c) has not been in contact in 30 days preceding the date of slaughter with poultry that does not fulfil the conditions set out in (a) and (b).

 

Annex VIII

(as referred to in Article 14(1)(a))

BREEDING AND PRODUCTIVE POULTRY OTHER THAN RATITES, HATCHING EGGS AND DAY-OLD CHICKS OTHER THAN OF RATITES

  1. Requirements applicable before import

 

  1. Breeding and productive poultry other than ratites, hatching eggs and day-old chicks other than of ratites for import into the Community shall only come from establishments which have been approved by the competent authority of the third country concerned in accordance with conditions that are at least as strict as those laid down in Annex II to Directive 2009/158/EC and where such approval has not been suspended or withdrawn.
  2. Where breeding and productive poultry other than ratites, hatching eggs and day-old chicks other than of ratites and/or their flocks of origin are to undergo testing to meet the requirements of the relevant veterinary certificates laid down in this Regulation, sampling for testing and the testing itself must be carried out in accordance with Annex III.
  3. Hatching eggs for import into the Community shall bear the name of the third country of origin and the word «hatching» that is more than 3 mm high in one of the official languages of the Community.
  4. Each package of hatching eggs as referred to in point 3 shall contain only eggs of a single species, category and type of poultry from the same third country, territory, zone or compartment of origin and consignor, and shall bear at least the following particulars:

(a) the information shown on the eggs as provided for in point 3;

(b) the species of poultry from which the eggs come;

(c) the consignor’s name or business name and address.

  1. Each box of imported day-old chicks shall contain only a single species, category and type of poultry from the same third country, territory, zone or compartment of origin, hatchery and consignor and shall bear at least the following particulars:

(a) the name of the third country, territory, zone or compartment of origin;

(b) the species of poultry to which the day-old chicks belong;

(c) the distinguishing number of the hatchery;

(d) the consignor’s name or business name and address.

 

  1. Requirements applicable after imports

 

  1. Imported breeding and productive poultry other than ratites and day-old chicks other than of ratites shall be kept on the establishment(s) of destination from their date of arrival:

(a) for a period of at least six weeks; or

(b) where the birds are slaughtered before the expiry of the period referred to in (a), until the day of slaughter.

However, the period provided for in (a) may be reduced to three weeks, provided that sampling and testing in accordance with Annex III have been carried out with favourable results.

  1. Breeding and productive poultry other than ratites which have been hatched from imported hatching eggs shall be kept for at least three weeks from the date of hatching in the hatchery or for at least three weeks on the establishment(s) to which the poultry has been sent after hatching.

Where day-old chicks are not reared in the Member State which imported the hatching eggs, they shall be transported directly to the final destination (as specified in points 1.10 and 1.11 of the health certificate, Model 2 in Annex IV to Directive 2009/158/EC) and kept there for at least three weeks from the date of hatching.

  1. During the relevant periods, as referred to in points 1 and 2, imported breeding and productive poultry and day-old chicks and breeding and productive poultry other than ratites which have hatched from imported hatching eggs shall be kept in isolation in poultry houses where no other flocks are present.

However, they may be introduced into poultry houses where breeding and productive poultry and day-old chicks are already present.

In that case, the relevant periods referred to in points 1 and 2 shall commence from the date of introduction of the last imported bird and no poultry present shall be moved from the poultry houses before the end of those periods.

  1. Imported hatching eggs shall be hatched in separate incubators and hatchers.

However, imported hatching eggs may be introduced into incubators and hatchers where other hatching eggs are already present.

In that case, the periods referred to in points 1 and 2 shall commence from the date of introduction of the last imported hatching egg.

  1. No later than the date of expiry of the relevant periods as provided for in point 1 or 2, imported breeding and productive poultry and day-old chicks shall undergo a clinical examination carried out by the official veterinarian and, where necessary, samples shall be taken to monitor their state of health.

Annex IX

(as referred to in Article 14(1)(b))

RATITES FOR BREEDING AND PRODUCTION, HATCHING EGGS AND DAY-OLD CHICKS THEREOF

  1. Requirements applicable before import

 

  1. Imported ratites for breeding and production (ratites) shall be identified by neck-tags and/or microchips bearing the ISO code of the third country of origin. Such microchips must comply with ISO standards.
  2. Imported hatching eggs of ratites shall be marked with a stamp indicating the ISO code of the third country of origin and the approval number of the establishment of origin.
  3. Each package of hatching eggs as referred to in point 2 shall contain only eggs of ratites from the same third country, territory, zone or compartment of origin and consignor, and shall bear at least the following particulars:

(a) the information shown on the eggs as provided for in point 2;

(b) a clearly visible and legible indication that the consignment contains hatching eggs of ratites;

(c) the consignor’s name or business name and address.

  1. Each box of imported day-old chicks of ratites for breeding and production shall contain only ratites from the same third country, territory, zone or compartment of origin, establishment and consignor, and shall bear at least the following particulars:

(a) the ISO code of the third country of origin and the approval number of the establishment of origin;

(b) a clearly visible and legible indication that the consignment contains day-old chicks of ratites;

(c) the consignor’s name or business name and address.

 

  1. Requirements applicable after import

 

  1. After the import controls have been carried out in accordance with Directive 91/496/EEC, consignments of ratites and hatching eggs and day-old chicks thereof shall be transported directly to the final destination.
  2. Imported ratites and day-old chicks thereof shall be kept on the establishment(s) of destination from their date of arrival:

(a) for a period at least six weeks; or

(b) where the birds are slaughtered before the expiry of the period referred to in (a), until the day of slaughter.

  1. Ratites which have hatched from imported hatching eggs shall be kept for a period of at least three weeks from the date of hatching in the hatchery or for at least three weeks on the establishment(s) to which they have been sent after hatching.

Where day-old chicks of ratites are not reared in the Member State which imported the hatching eggs, they shall be transported directly to the final destination (as specified in points I.10 and I.11 of the health certificate, Model 2, in Annex IV to Council Directive 2009/158/EC <*>) and kept there for at least three weeks from the date of hatching.

———————————

<*> OJ L 343, 22.12.2009, p. 74.

 

  1. During the relevant periods as referred to in points 2 and 3, imported ratites and ratites which have hatched from imported hatching eggs shall be kept in isolation in poultry houses where no other ratites or poultry are present.

However, they may be introduced into poultry houses where other ratites or poultry are already present. In that case, the periods referred to in points 2 and 3 shall commence from the date of introduction of the last imported ratite and no ratites or poultry present shall be moved from the poultry housing before the end of those periods.

  1. Imported hatching eggs shall be hatched in separate incubators and hatchers.

However, imported hatching eggs may be introduced into incubators and hatchers where other hatching eggs are already present. In that case, the periods referred to in points 2 and 3 shall commence from the date of introduction of the last imported hatching egg and the measures as provided for in those points shall apply.

  1. No later than the date of expiry of the relevant periods as referred to in point 2 or 3, imported ratites and day-old chicks thereof shall undergo a clinical examination carried out by an official veterinarian and, where necessary, samples shall be taken to monitor their state of health.

 

III. Requirements for ratites for breeding and production and day-old chicks thereof from Asia and Africa applicable on their import into the Community

 

The protective measures for Crimean-Congo haemorrhagic fever set out in Part I of Annex X shall apply to ratites for breeding and production and day-old chicks thereof coming from third countries, territories, zones or compartments in Asia and Africa.

All ratites testing positive to the competitive ELISA test for antibodies to Crimean Congo haemorrhagic fever provided for therein shall be destroyed.

All birds of the same consignment shall be retested by the competitive ELISA test 21 days after the date of the original sampling. Where any bird tests positive all birds in the same consignment shall be destroyed.

 

  1. Requirements for ratites for breeding and production from a third country, territory or zone considered to be infected with Newcastle disease

 

The following rules shall apply to ratites and hatching eggs thereof coming from a third country, territory or zone considered as infected with Newcastle disease and to day-old chicks that have hatched from such eggs:

(a) before the date the isolation period begins, the competent authority shall check the isolation facilities as referred to in point 4 of Part II of this Annex to verify whether they are satisfactory;

(b) during the relevant periods as referred to in points 2 and 3 of Part II of this Annex a virus isolation test for Newcastle disease shall be carried out on a cloacal swab or faeces sample from each ratite;

(c) where ratites are to be sent to a Member State, the status of which has been established in accordance with Article 12(2) of Directive 2009/158/EC, a serological test shall be carried out on each ratite, in addition to the virus isolation test provided for in point (b) of this Part;

(d) negative results of the tests provided for in points (b) and (c) shall be available before any bird is released from isolation.

 

Annex X

(as referred to in Article 17)

PROTECTIVE MEASURES IN RELATION TO CRIMEAN-CONGO HAEMORRHAGIC FEVER

  1. For ratites

 

The competent authority shall ensure that the ratites are isolated in rodent-proof, tick-free surroundings for at least 21 days prior to the date of import into the Community.

Before moving to the tick-free surroundings, the ratites shall be treated to ensure that all ectoparasites on them are destroyed. After 14 days in tick-free surroundings, the ratites shall undergo the competitive ELISA test for anti-bodies to Crimean-Congo haemorrhagic fever. Every animal put into isolation must test negative to the test. On the ratites’ arrival in the Community, the treatment for ectoparasites and the serological test shall be repeated.

 

  1. For ratites from which meat for import is derived

 

The competent authority shall ensure that the ratites are isolated in rodent-proof, tick-free surroundings for at least 14 days prior to the date of slaughter.

Before moving to the tick-free surroundings, the ratites shall either be examined to verify that they are tick-free or treated to ensure that all ticks on them are destroyed. The treatment used must be specified on the import certificate. Any treatment used shall not result in any detectable residues in the ratite meat.

Each batch of ratites shall be examined for ticks prior to slaughter. If any ticks are detected, the entire batch shall again be put into pre-slaughter isolation.

 

Annex XI

(as referred to in Article 18(2))

MODEL VETERINARY CERTIFICATE FOR TRANSIT/STORAGE OF SPECIFIED PATHOGEN-FREE EGGS, MEAT, MINCED MEAT AND MECHANICALLY SEPARATED MEAT OF POULTRY, RATITES AND WILD GAME-BIRDS, EGGS AND EGG PRODUCTS

COUNTRY Veterinary certificate to EU
Part I: Details of dispatched consignment I.1. Consignor

Name

 

Address

 

Tel. No

I.2. Certificate reference number I.2.a.
I.3. Central Competent Authority
I.4. Local Competent authority
I.5. Consignee

Name

 

Address

Postal code

Tel. No

I.6. Person responsible for the load in EU

Name

 

Address

Postal code

Tel. No

I.7. Country of origin ISO code I.8. Region of origin Code I.9. Country of destination ISO code I.10. Region of destination Code
I.11. Place of origin I.12. Place of destination
Name

Address

 

 

Approval number Custom warehouse

 

Name

Address

 

Postal code

Ship supplier

 

Approval number

I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU
Aeroplane Ship Railway wagon
Road vehicle

Identification:

Other I.17.
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20. Quantity
I.21. Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24. Type of packaging
I.25. Commodities certified for:
Human consumption
I.26. For transit through EU to 3rd Country I.27.
3rd country ISO code
I.28. Identification of the commodities

Aporoval number of establishments

Species

(Scientific name)

 

 

Nature of commodity Treatment type Abattoir Manufacturing plant Cold store Number of packages Net weight
COUNTRY Transit/storage of specified pathogen-free eggs, meat, minced meat and mechanically separated meat of poultry, ratites and wild game-birds, eggs and egg products
Part II: Certification II. Health information II.a. Certificate reference number II.b.
II.1. Health attestation
I, the undersigned official veterinarian, hereby certify that specified pathogen-free eggs, the meat, minced meat and mechanically separated meat of poultry, ratites and wild game-birds, eggs and egg products <1> described in this certificate:
II.1.1 come from a third country, territory, zone or compartment appearing in Part 1 of Annex I to Regulation (EC) No 798/2008, and
<2> II.1.2 complies (comply) with the relevant animal health conditions laid down in the animal health attestation in the model certificates in Annex I to Regulation (EC) No 798/2008.
Notes
Part I:
— Box I.8: provide the code for the zone or the compartment of origin, if necessary, as defined under code of column 2 of Part 1 of Annex I to Regulation (EC) No 798/2008.
— Box I.11: Name, address and approval number of the establishment of dispatch.
— Box I.15: Indicate the registration number(s) of railway wagons and lorries, the names of ships and, if known, the flight numbers of aircraft. In the case of transport in containers or boxes, the total number of these and their registration and where there is a serial number of the seal it has to be indicated in box I.23.
— Box I.19: use the appropriate Harmonised System (HS) code of the World Customs Organisation: 02.07; 02.08.90; 04.07; 04.08 or 21.06.10
Part II
<1> Specified pathogen-free eggs, meat, minced meat and mechanically separated meat of poultry, ratites and wild game-birds, eggs and egg products as laid down in Part 1 of Annex I to Regulation (EC) No 798/2008.
<2> In the case of specified pathogen-free eggs [SPF], meat of poultry [POU], meat of ratites [RAT], wild game-bird meat [WGM], minced meat and mechanically separated meat of poultry [POU-MI/MSM], minced meat and mechanically separated meat of ratites [RAT-MI/MSM], wild game-bird minced meat and mechanically separated meat [WGM-MI/MSM], eggs [E] or egg products [EP].
Official veterinarian
Name (in capital letters): Qualification and title:
Date: Signature:
Stamp:

 

Annex XII

(as referred to in Article 20)

CORRELATION TABLE

This Regulation Decision 2006/696/EC Decision 94/438/EC Decision 93/342/EEC
Article 1(1) first subparagraph Article 1 first subparagraph
Article 1(1) second subparagraph Article 5
Article 1(2) Article 1 second subparagraph
Article 1(3) Annex I and II (part1)
Article 2 (1 — 5) Article 2 (a — e)
Article 2 (6) Article 2 (m)
Article 2 (7) Article 2 (j)
Article 2 (8) Article 2 (k)
Article 2 (9) Article 2 (l)
Article 2 (10)
Article 2 (11)
Article 2 (12) (a — c) Article 2 (g)
Article 2 (12) (d)
Article 2 (13) Article 2 (h)
Article 2 (14) Article 2 (f)
Article 2 (15)
Article 2 (16)
Article 2 (17)
Article 2 (18)
Article 2 (19)
Article 2 (20)
Article 3 Article 5
Article 4 first subparagraph Article 5 and 3
Article 4 second subparagraph Annex I part 3
Article 4 third subparagraph Article 3 second subparagraph
Article 5 Article 4
Article 6
Article 7 (a) Article 2 (h)
Article 7 (b) Article 2 (g)
Article 7 (c) Article 2 (i)
Article 8
Article 9
Article 10
Article 11
Article 12 Article 4 (1) (2) Article 4 (1) (2)
Article 13 Article 4 (3) Article 4 (4)
Article 14 (1) (a) Article 9
Article 14 (1) (b) Article 11
Article 14 (2)
Article 15 Article 18
Article 16 Article 8
Article 17 Article 16 (2)
Article 18 (1)
Article 18 (2) Article 19 (b)
Article 18 (3) Article 19
Article 19 Article 20
Article 20
Article 21
Article 22
Annex I Annex I and II
Annex II Annex I part 3
Annex III (I) (1 — 6) Annex I part 4 (A)
Annex III (I) (7)
Annex III (II), (III) Annex I part 4 (B)
Annex IV
Annex V
Annex VI Annex B
Annex VII (I) Article 7
Annex VII (II) Annex
Annex VIII (I) Article 9
Annex VIII (II) Article 10
Annex IX (I) Article 11
Annex IX (II) Article 12
Annex IX (III) Article 13
Annex IX (IV) Article 14
Annex X Annex V
Annex XI Annex IV
Annex XII

1   2   3   4   5   6   7   8   9   10   11   12   13   14   15   16   17   18   19   20   21

Добавить комментарий

Ваш e-mail не будет опубликован.

*

code