2008R0798 — EN — 23.05.2009 — 001.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

►B COMMISSION REGULATION (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (Text with EEA relevance) (OJ L 226, 23.8.2008, p.1)

Amended by:









▼B

COMMISSION REGULATION (EC) No 798/2008

of 8 August 2008

laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements

(Text with EEA relevance)







THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs ( 1 ), and in particular Article 21(1), Article 22(3) Article 23, Article 24(2) and Articles 26 and 27a thereof, Having regard to Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC ( 2 ), and in particular Articles 10 and 18 thereof, Having regard to Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC ( 3 ), and in particular the fourth subparagraph of Article 29(1), thereof, Having regard to Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries ( 4 ), and in particular Article 22(1) thereof, Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption ( 5 ), and in particular Article 8, Article 9(2)(b) and Article 9(4) thereof, Having regard to Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents ( 6 ), and in particular Article 10(2) thereof, Having regard to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin ( 7 ), and in particular Article 9 thereof, Having regard to Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption ( 8 ), and in particular Article 11(1) thereof, Whereas: (1) Directive 90/539/EEC lays down animal health conditions governing imports into the Community from third countries of poultry and hatching eggs. It provides that poultry and hatching eggs are to satisfy the conditions laid down therein and originate in a third country or part thereof included on a list drawn up in accordance with that Directive. (2) Directive 2002/99/EC lays down rules governing the introduction from third countries of products of animal origin and products obtained there from intended for human consumption. It provides that such products are only to be imported into the Community if they comply with the requirements applicable to all stages of the production, processing and distribution of those products in the Community or if they offer equivalent animal health guarantees. (3) Commission Decision 2006/696/EC of 28 August 2006 laying down a list of third countries from which poultry, hatching eggs, day-old chicks, meat of poultry, ratites and wild game-birds, eggs and egg products and specified pathogen-free eggs may be imported into and transit through the Community and the applicable veterinary certification conditions ( 9 ) sets out a list of third countries from which the commodities concerned may be imported into, and transit through, the Community and lays down the veterinary certification conditions. (4) Commission Decision 93/342/EEC of 12 May 1993 laying down the criteria for classifying third countries with regard to avian influenza and Newcastle disease in relation to imports of live poultry and hatching eggs ( 10 ) and Commission Decision 94/438/EC of 7 June 1994 laying down the criteria for classifying third countries and parts thereof with regard to avian influenza and Newcastle disease in relation to imports of fresh poultrymeat ( 11 ) lay down criteria for classifying third countries with regard to avian influenza and Newcastle disease in relation to imports of live poultry, hatching eggs and poultrymeat. (5) Community legislation for the control of avian influenza has recently been updated by Council Directive 2005/94/EC of 20 December 2005 on Community measures for the control of avian influenza ( 12 ), to take account of the most recent scientific knowledge and developments on the epidemiology of avian influenza in the Community and worldwide. The scope of the control measures to be applied in the event of an outbreak has been extended from highly pathogenic avian influenza (HPAI) to deal also with outbreaks of low pathogenic avian influenza (LPAI), and to introduce compulsory active surveillance for avian influenza and a wider use of vaccination against this disease. (6) Imports from third countries should therefore meet conditions equivalent to those applied within the Community and which are in line with the revised requirements for international trade in poultry and poultry products laid down by the standards of the Terrestrial Animal Health Code of the World Organisation for Animal health (OIE) ( 13 ) and the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals ( 14 ) of the OIE. (7) Argentina and Israel have submitted their avian influenza surveillance programmes to the Commission for evaluation. The Commission has examined these programmes and they conform to the relevant Community provisions and therefore a positive evaluation of these programmes should be indicated in the column 7 of part 1 of Annex I to this Regulation. (8) Article 21(2) of Directive 90/539/EEC sets out certain matters that are to be taken into account when deciding whether or not a third country or part thereof maybe included in the list of third countries from which poultry and hatching eggs may be imported into the Community, such as the state of health of poultry, the regularity and rapidity of the supply of information by a third country relating to the existence of certain contagious animal diseases, including avian influenza and Newcastle disease and the rules for animal disease prevention and control in the third country concerned. (9) Article 8 of Directive 2002/99/EC provides that when drawing up lists of third countries or regions of third countries thereof from which imports of specified products of animal origin are permitted into the Community, particular account is to be taken of certain matters, such as the health status of livestock, the regularity, speed and accuracy with which the third country supplies information on the existence of certain infectious or contagious animal diseases in its territory, in particular avian influenza and Newcastle disease and the general health situation in the third country concerned which might pose a risk to public or animal health in the Community. (10) In the interests of animal health, this Regulation should provide that commodities should only be imported into the Community from third countries, territories, zones or compartments which have in place avian influenza surveillance programmes and avian influenza vaccination plans, where such vaccination is carried out. (11) Pursuant to Regulation (EC) No 2160/2003, admission to or retention on the lists of third countries provided for in Community legislation from which Member States are authorised to import certain poultry commodities covered by that Regulation is subject to the submission to the Commission by the third country concerned of a programme equivalent to national control programmes for Salmonella to be established by the Member States, and its approval by the Commission. A positive evaluation of these programmes should be indicated in part 1 of Annex I to this Regulation. (12) The Community and certain third countries wish to permit trade in poultry and poultry products coming from approved compartments and therefore the principle of compartmentalisation for imports of poultry and poultry products should be further laid down in Community legislation. The compartmentalisation principle has been laid down recently by the OIE in order to facilitate world wide trade in poultry and poultry products and therefore it should be incorporated into Community legislation. (13) Currently Community legislation does not provide for certificates for the import into the Community of minced meat and mechanically separated meat of poultry, ratites and wild game-birds, for certain health reasons, in particular the traceability of meat used for its production. Accordingly, model veterinary certificates covering those commodities should be provided for in this Regulation following further scientific investigations. (14) In order to provide more flexibility in certain situations for the competent authorities for veterinary certificates purposes, and based on several requests from third countries exporting day-old chicks of poultry and ratites to the Community, this Regulation should provide that such commodities should be examined at the time of dispatch of the consignment instead of at the time of issue of the veterinary certificate. (15) In order to avoid any interruption in trade, imports into the Community of commodities that have been produced before the introduction of animal health restrictions, as set out in Part 1 of Annex I to this Regulation, should continue to be permitted for 90 days following the introduction of import restrictions for the commodity concerned. (16) Specific conditions for transit via the Community of consignments to and from Russia should be provided for owing to the geographical situation of Kaliningrad which affects only Latvia, Lithuania and Poland. (17) Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) ( 15 ) set out general Community health rules applicable to the import into, and transit through, the Community of the commodities covered by the Regulation. (18) In addition, Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products ( 16 ) lays down standards of certification which are necessary to ensure valid certification and to prevent fraud. It is, therefore, appropriate to ensure in this Regulation that the rules and principles applied by third country certifying officers provide guarantees that are equivalent to those laid down in that Directive and that the model veterinary certificates laid down in this Regulation reflect only such facts as may be attested at the time the certificate is issued. (19) In the interests of clarity and coherence of Community legislation, Decisions 93/342/EEC, 94/438/EC and 2006/696/EC should be repealed and replaced by this Regulation. (20) It is appropriate to provide for a transitional period to permit Member States and industry to take the necessary measures to comply with the applicable veterinary certification requirements laid down in this Regulation. (21) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Whereas: HAS ADOPTED THIS REGULATION:







CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter and scope

1. This Regulation lays down veterinary certification requirements for imports into and transit, including storage during transit, through the Community of the following commodities (the commodities):

(a) poultry, hatching eggs, day-old chicks and specified pathogen-free eggs;

(b) meat, minced meat and mechanically separated meat of poultry, including ratites and wild game-birds, eggs and egg products.

It lays down a list of third countries, territories, zones or compartments from which the commodities may be imported into the Community.

2. This Regulation shall not apply to poultry for exhibitions, shows or contests.

3. This Regulation shall apply without prejudice to specific certification requirements provided for in Community agreements with third countries.

Article 2

Definitions

For the purposes of this Regulation, the following definitions shall apply:

(1) ‘poultry’ means fowl, turkeys, guinea fowl, ducks, geese, quails, pigeons, pheasants, partridges and ratites (ratitae), reared or kept in captivity for breeding, the production of meat or eggs for consumption, or for restocking supplies of game;

(2) ‘hatching eggs’ means eggs for incubation, laid by poultry;

(3) ‘day-old chicks’ means all poultry less than 72 hours old, not yet fed and muscovy ducks (Cairina moschata) or their crosses, less than 72 hours old whether or not fed;

(4) ‘breeding poultry’ means poultry 72 hours old or more, intended for the production of hatching eggs;

(5) ‘productive poultry’ means poultry 72 hours old or more, reared for: (a) the production of meat and/or eggs for consumption; or (b) the restocking of supplies of game;

(6) ‘specified pathogen-free eggs’ means hatching eggs which are derived from ‘chicken flocks free from specified pathogens’, as described in the European Pharmacopoeia ( 17 ), and which are intended solely for diagnostic, research or pharmaceutical use;

(7) ‘meat’ means edible parts of the following animals: (a) poultry, which, when relating to meat, means farmed birds, including birds that are farmed as domestic animals without being considered as such, with the exception of ratites; (b) wild game-birds that are hunted for human consumption; (c) ratites;

(8) ‘mechanically separated meat’ means the product obtained by removing meat from flesh-bearing bones after boning or from poultry carcases, using mechanical means resulting in the loss or modification of the muscle fibre structure;

(9) ‘minced meat’ means de-boned meat that has been minced into fragments and contains less than 1 % salt;

(10) ‘zone’ means a clearly defined part of a third country containing an animal subpopulation with a distinct health status with respect to a specific disease for which the required surveillance, control and biosecurity measures have been applied for the purpose of imports under this Regulation;

(11) ‘compartment’ means one or more poultry establishments in a third country under a common biosecurity management system containing a poultry subpopulation with a distinct health status with respect to a specific disease or diseases for which the required surveillance, control and biosecurity measures have been applied for the purpose of imports under this Regulation;

(12) ‘establishment’ means a facility or part of a facility which occupies a single site and is devoted to one or more of the following activities: (a) pedigree breeding establishment: an establishment which produces hatching eggs for the production of breeding poultry; (b) breeding establishment: an establishment which produces hatching eggs for the production of productive poultry; (c) rearing establishment either: (i) a breeding poultry-rearing establishment which rears breeding poultry prior to the reproductive stage; or (ii) a productive poultry-rearing establishment which rears egg-laying productive poultry prior to the laying stage; (d) keeping of other productive poultry;

(13) ‘hatchery’ means an establishment which incubates and hatches eggs and supplies day-old chicks;

(14) ‘flock’ means all poultry of the same health status kept on the same facilities or in the same enclosure and constituting a single epidemiological unit; as regards housed poultry, this definition includes all birds sharing the same airspace;

(15) ‘avian influenza’ means an infection of poultry caused by any influenza A virus: (a) of the subtypes H5 or H7; (b) with an intravenous pathogenicity index (IVPI) in six-week old chickens greater than 1,2; or (c) causing at least 75 % mortality in four- to 8-week-old chickens infected intravenously;

(16) ‘highly pathogenic avian influenza’ (HPAI) means an infection of poultry caused by: (a) avian influenza viruses of the subtypes H5 or H7 with genome sequences codifying for multiple basic amino acids at the cleavage site of the haemagglutinin molecule similar to that observed for other HPAI viruses, indicating that the haemagglutinin molecule can be cleaved by a host ubiquitous protease; (b) avian influenza as defined in point 15(b) and (c);

(17) ‘low pathogenic avian influenza’ (LPAI) means an infection of poultry caused by avian influenza viruses of subtypes H5 or H7 other than HPAI;

(18) ‘Newcastle disease’ means an infection of poultry: (a) caused by any avian strain of the paramyxovirus 1 with an intracerebral pathogenicity index (ICPI) in day-old chicks greater than 0,7; or (b) multiple basic amino acids have been demonstrated in the virus (either directly or by deduction) at the C-terminus of the F2 protein and phenylalanine at residue 117, which is the N-terminus of the F1 protein; the term ‘multiple basic amino acids’ refers to at least three arginine or lysine residues between residues 113 and 116; failure to demonstrate the characteristic pattern of amino acid residues as described in this point requires characterisation of the isolated virus by an ICPI test; in this definition, amino acid residues are numbered from the N-terminus of the amino acid sequence deduced from the nucleotide sequence of the F0 gene, 113-116 corresponds to residues -4 to -1 from the cleavage site;

(19) ‘official veterinarian’ means the veterinarian designated by the competent authority;

(20) ‘differentiating infected from vaccinated animal (DIVA) strategy’ means a vaccination strategy which enables a differentiation to be made between vaccinated/infected and vaccinated/non-infected animals through the application of a diagnostic test designed to detect antibodies against the field virus and the use of non-vaccinated sentinel birds.







CHAPTER II

GENERAL CONDITIONS FOR IMPORTS AND TRANSIT

Article 3

Lists of third countries, territories, zones or compartments of origin from which commodities may be imported into and transit through the Community

The commodities shall only be imported into and transit through the Community from the third countries, territories, zones or compartments listed in columns 1 and 3 of the table in Part 1 of Annex I.

Article 4

Veterinary certification

1. Commodities imported into the Community shall be accompanied by a veterinary certificate, as referred to in column 4 of the table in Part 1 of Annex I, for the commodity concerned, completed in accordance with the notes and the model veterinary certificates set out in Part 2 of that Annex (the certificate).

2. A declaration by the master of the ship, as set out in Annex II, shall be attached to veterinary certificates for imports of poultry and day-old chicks, where the transport of those commodities includes transport by ship, even for part of the journey.

3. Poultry, hatching eggs and day-old chicks transiting through the Community shall be accompanied by:

(a) a veterinary certificate as referred to in paragraph 1 which shall bear the words ‘for transit through the EC’, and

(b) a certificate required by the third country of destination.

4. Specified pathogen-free eggs, meat, minced meat and mechanically separated meat of poultry, ratites and wild game-birds, eggs and egg products transiting through the Community shall be accompanied by a certificate drawn up in accordance with the model certificate set out in Annex XI and complying with the conditions set out therein.

5. For the purposes of this Regulation, transit may include storage during transit in accordance with Articles 12 and 13 of Directive 97/78/EC.

6. Electronic certification and other agreed systems harmonised at Community level may be used.

Article 5

Conditions for imports and transit

1. Commodities imported into and transiting through the Community shall comply with the conditions laid down in Articles 6 and 7 and in Chapter III.

2. Paragraph 1 shall not apply to single consignments of fewer than 20 units of poultry other than ratites, hatching eggs or day-old chicks thereof. However, such single consignments may only be imported from third countries, territories, zones or compartments thereof that are approved for such imports and they comply with the following conditions:

(a) third country, territory, zone or compartment is listed in columns 1 and 3 of the table in Part 1 of Annex I and column 4 of that table provides for a model veterinary certificate for the commodity concerned;

(b) they are not covered by an import ban for animal health reasons;

(c) the importation conditions include the requirement for post-import isolation or quarantine.

3. Commodities referred to in paragraph 1 shall comply with the following:

(a) the additional guarantees, as specified in column 5 of the table in Part 1 of Annex I;

(b) the specific conditions set out in column 6, and where appropriate, the closing dates set out in column 6A and the opening dates set out in column 6B, of the table in Part 1 of Annex I;

(c) the animal health additional guarantees, where required by the Member State of destination and referred to in the certificate;

(d) the restrictions in relation to the approval of a Salmonella control programme, shall only apply when indicated in the appropriate column of the table in Part 1 of Annex I.

Article 6

Examination, sampling and testing procedures

Where examination, sampling and testing for avian influenza, Mycoplasma, Newcastle disease, Salmonella, and other pathogens of animal or public health significance is required for imports of commodities into the Community in accordance with the certificates, such commodities shall only be imported into the Community where those examinations, sampling and testing have been carried out by the competent authority of the third country concerned or where appropriate by the competent authority of the Member State of destination in accordance with Annex III.

Article 7

Disease reporting requirements

Commodities shall only be imported into the Community from third countries, territories, zones or compartments, where the third country concerned:

▼M2

(a) informs the Commission of the disease situation within 24 hours of confirmation of any initial outbreaks of LPAI, HPAI or Newcastle disease;

(b) submits virus isolates from initial outbreaks of HPAI and Newcastle disease, without undue delay to the Community reference laboratory for avian influenza and Newcastle disease ( 18 ); such virus isolates shall not be required for imports of eggs, egg products and specified pathogen-free eggs from third countries, territories, zones or compartments from which the import of such commodities into the Community is authorised;

▼B

(c) submits to the Commission regular updates on the disease situation.







CHAPTER III

ANIMAL HEALTH STATUS OF THIRD COUNTRIES, TERRITORIES, ZONES OR COMPARTMENTS OF ORIGIN WITH REGARD TO AVIAN INFLUENZA AND NEWCASTLE DISEASE

Article 8

Avian influenza free third countries, territories, zones or compartments

1. For the purposes of this Regulation, a third country, territory, zone or compartment from which commodities are imported into the Community shall be considered as free from avian influenza where:

(a) avian influenza has not been present in the third country, territory, zone or compartment for a period of at least 12 months preceding the certification by the official veterinarian;

(b) an avian influenza surveillance programme, in accordance with Article 10 has been carried out during a period of at least six months preceding the certification referred to in point (a) of this paragraph where required in the certificate.

2. Where an outbreak of avian influenza occurs in a third country, territory, zone or compartment previously free of that disease, as referred to in paragraph 1, that third country, territory, zone or compartment shall again be considered as free from avian influenza provided the following conditions have been met:

(a) in the case of HPAI, a stamping out policy has been implemented to control the disease;

(b) in the case of LPAI, either a stamping out policy has been implemented or the poultry have been slaughtered to control the disease;

(c) adequate cleansing and disinfection has been carried out on all previously infected establishments;

(d) avian influenza surveillance has been carried out in accordance with Part II of Annex IV during a three-month period following completion of the cleansing and disinfection referred to in point (c) of this paragraph with negative results.

Article 9

HPAI free third countries, territories, zones and compartments

1. For the purposes of this Regulation, a third country, territory, zone or compartment from which commodities are imported into the Community shall be considered as free from HPAI where that disease has not been present in the third country, territory, zone or compartment for a period of at least 12 months preceding the certification by the official veterinarian.

2. Where an outbreak of HPAI occurs in a third country, territory, zone or compartment previously free of that disease as referred to in paragraph 1, that third country, territory, zone or compartment shall again be considered as free of HPAI, provided the following conditions are met:

(a) a stamping out policy has been implemented to control the disease, including adequate cleansing and disinfection carried out on all previously infected establishments;

(b) avian influenza surveillance has been carried out in accordance with Part II of Annex IV during a three-month period following completion of the stamping out policy and cleansing and disinfection referred to in point (a).

Article 10

Avian influenza surveillance programmes

Where an avian influenza surveillance programme is required in the certificate, commodities shall only be imported into Community from third countries, territories, zones or compartments where:

(a) the third country, territory, zone or compartment has had in place for a period of at least six months an avian influenza surveillance programme, which is indicated in column 7 of the table in Part 1 of Annex I, and that programme meets the requirements: (i) set out in Part I of Annex IV; or (ii) of the Terrestrial Animal Health Code of the OIE ( 19 );

(b) the third country informs the Commission of any changes to its avian influenza surveillance programme.

Article 11

Vaccination against avian influenza

Where vaccination against avian influenza is carried out in third countries, territories, zones or compartments, poultry or other commodities derived from vaccinated poultry shall only be imported into the Community, where:

(a) the third country carries out vaccination against avian influenza in accordance with a vaccination plan indicated in column 8 of the table in Part 1 of Annex I, and that plan meets the requirements set out in Annex V;

(b) the third country informs the Commission of any changes to its avian influenza vaccination plan.

Article 12

Newcastle disease free third countries, territories, zones and compartments

1. For the purposes of this Regulation, a third country, territory, zone or compartment from which commodities are imported into the Community shall be considered as free from Newcastle disease where the following conditions are met:

(a) no outbreaks of Newcastle disease have occurred in poultry in the third country, territory, zone or compartment for a period of at least 12 months preceding the certification by the official veterinarian;

(b) no vaccination against Newcastle disease using vaccines that do not comply with the criteria for recognised Newcastle disease vaccines set out in Annex VI has been carried out for at least the period referred to in point (a) of this paragraph.

2. Where an outbreak of Newcastle disease occurs in a third country, territory, zone or compartment previously free from that disease, as referred to in paragraph 1, that third country, territory, zone or compartment shall again be considered as free from that disease provided the following conditions are met:

(a) a stamping out policy has been implemented to control the disease;

(b) adequate cleansing and disinfection has been carried out on all previously infected establishments;

(c) during a period of at least three months following the completion of the stamping out policy and cleansing and disinfection referred to in points (a) and (b): (i) the competent authority of a the third country can demonstrate the absence of that disease in the third country, territory, zone or compartment by intensified investigations including laboratory testing in relation to the outbreak; (ii) no vaccination against Newcastle disease using vaccines that do not comply with the criteria for recognised Newcastle disease vaccines set out in Annex VI has been carried out.

Article 13

Derogations concerning the use of vaccines against Newcastle disease

1. For commodities referred to in Article 1(1)(a), and by way of derogation from Article 12(1)(b) and Article 12(2)(c)(ii), a third country, territory, zone or compartment shall be considered as free from Newcastle disease where the following conditions are met:

(a) the third country, territory, zone or compartment allows the use of vaccines which comply with the general criteria set out in Part I of Annex VI, but not with the specific criteria set out in Part II of that Annex;

(b) the additional health requirements set out in Part I of Annex VII are complied with.

2. For commodities referred to in Article 1(1)(b), and by way of derogation from Article 12(1)(b) and Article 12(2)(c)(ii), a third country, territory, zone or compartment from which imports of poultrymeat into the Community are authorised, shall be considered as free from Newcastle disease where the additional health requirements laid down in Part II of Annex VII are complied with.







CHAPTER IV

SPECIFIC CONDITIONS FOR IMPORTS

Article 14

Specific conditions for imports of poultry, hatching eggs and day-old chicks

1. In addition to the conditions laid down in Chapters II and III, the following specific conditions shall apply to imports of:

(a) breeding and productive poultry other than ratites, hatching eggs and day-old chicks other than of ratites, the requirements set out in Annex VIII;

(b) ratites for breeding and production, hatching eggs and day-old chicks thereof, the requirements set out in Annex IX.

2. The conditions provided for in paragraph 1 shall not apply to single consignments of less than 20 units of poultry other than, ratites, hatching eggs or day-old chicks thereof.

Article 15

Specific conditions for imports of specified pathogen-free eggs

In addition to the requirements provided for in Articles 3 to 6, specified pathogen-free eggs imported into the Community shall comply with the following requirements:

(a) they shall be marked with a stamp bearing the ISO code of the third country of origin and the approval number of the establishment of origin;

(b) each package of specified pathogen-free eggs must only contain eggs from the same third country of origin, establishment and consignor, and must bear at least the following particulars: (i) the information shown on the eggs as provided for in point (a); (ii) a clearly visible and legible indication that the consignment contains specified pathogen-free eggs; (iii) the consignor’s name or business name and address.

(c) specified pathogen-free eggs imported into the Community must be transported directly to their final destination after import controls have been completed satisfactorily.

Article 16

Specific conditions for transport of poultry and day-old chicks

Poultry and day-old chicks imported into the Community shall not be:

(a) loaded onto a means of transport carrying other poultry and day-old chicks of a lower health status;

(b) in the course of transport to the Community, shall not be moved through nor unloaded in a third country, territory, zone or compartment from which imports of such poultry and day-old chicks into the Community are not authorised.

Article 17

Specific conditions for imports of meat of ratites

Only meat derived from ratites which have undergone the protective measures in relation to Crimean-Congo haemorrhagic fever, laid down in Part II of Annex X, may be imported into the Community.







CHAPTER V

SPECIFIC CONDITIONS FOR TRANSIT

Article 18

Derogation for transit through Latvia, Lithuania and Poland

1. By way of derogation from Article 4(4), transit by road or by rail shall be authorised between the border inspection posts in Latvia, Lithuania and Poland listed in the Annex to Commission Decision 2001/881/EC ( 20 ), of consignments of meat, minced meat and mechanically separated meat of poultry including ratites and wild game-birds, eggs and egg products and specified pathogen-free eggs coming from and bound for Russia, directly or via another third country, where the following conditions are met:

(a) the consignment is sealed with a serially numbered seal by the official veterinarian at the border inspection post of entry;

(b) the documents accompanying the consignment, as provided for in Article 7 of Directive 97/78/EC, are stamped with the words ‘Only for transit to Russia via the EC’ on each page by the official veterinarian at the border inspection post of entry;

(c) the procedural requirements provided for in Article 11 of Directive 97/78/EC are complied with;

(d) the consignment is certified as acceptable for transit on the common veterinary entry document issued by the official veterinarian at the border inspection post of entry.

2. The consignments, as referred to in paragraph 1, may not be unloaded or put into storage, as referred to in Article 12(4) or in Article 13 of Directive 97/78/EC, within the Community.

3. Regular audits shall be conducted by the competent authority to ensure that the number of consignments, as referred to in paragraph 1, and the corresponding quantities of products leaving the Community correspond with the number and quantities entering the Community.







CHAPTER VI

TRANSITIONAL AND FINAL PROVISIONS

Article 19

Repeals

Decisions 93/342/EEC, 94/438/EC and 2006/696/EC are repealed.

References to the repealed Decisions shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex XII.

Article 20

Transitional provisions

Commodities in respect of which the relevant veterinary certificates have been issued in accordance with Decisions 93/342/EEC, 94/438/EC and 2006/696/EC may be imported into or transit through the Community until 15 February 2009.

Article 21

Entry into force

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

It shall apply from 1 January 2009.

This Regulation shall be binding in its entirety and directly applicable in all Member States.









ANNEX I

POULTRY, HATCHING EGGS, DAY-OLD CHICKS, SPECIFIED PATHOGEN-FREE EGGS, MEAT, MINCED MEAT, MECHANICALLY SEPARATED MEAT, EGGS AND EGG PRODUCTS

▼M1

PART 1

List of third countries, territories, zones or compartments







ISO code and name of third country or territory Code of third country, territory, zone or compartment Description of third country, territory, zone or compartment Veterinary certificate Specific conditions Specific conditions Avian influenza surveillance status Avian influenza vaccination status Salmonella control status Model(s) Additional guarantees Closing date (1) Opening date (2) 1 2 3 4 5 6 6A 6B 7 8 9 AL — Albania AL-0 Whole country EP, E S4 AR — Argentina AR-0 Whole country SPF POU, RAT, EP, E A S4 WGM VIII AU — Australia AU-0 Whole country SPF EP, E S4 BPP, DOC, HEP, SRP S0 BPR I DOR II HER III POU VI RAT VII BR — Brazil BR-0 Whole country SPF BR-1 States of: Rio Grande do Sul, Santa Catarina, Paraná, São Paulo and Mato Grosso do Sul RAT, BPR, DOR, HER, SRA A BR-2 States of: Mato Grosso, Paraná, Rio Grande do Sul, Santa Catarina and São Paulo BPP, DOC, HEP, SRP S0 BR-3 Distrito Federal and States of: Goiás, Minas Gerais, Mato Grosso, Mato Grosso do Sul, Paraná, Rio Grande do Sul, Santa Catarina and São Paulo WGM VIII EP, E, POU S4 BW — Botswana BW-0 Whole country SPF EP, E S4 BPR I DOR II HER III RAT VII CA — Canada CA-0 Whole country SPF EP, E S4 BPR, BPP, DOC, DOR, HEP, HER, SRA, SRP A S1 WGM VIII POU, RAT CH — Switzerland CH-0 Whole country (3) A (3) CL — Chile CL-0 Whole country SPF EP, E S4 BPR, BPP, DOC, DOR, HEP, HER, SRA, SRP A S0 WGM VIII POU, RAT CN — China CN-0 Whole country EP CN-1 Province of Shandong POU, E VI P2 6.2.2004 — S4 GL — Greenland GL-0 Whole country SPF EP, WGM HK — Hong Kong HK-0 The whole territory of the Hong Kong Special Administrative Region EP HR — Croatia HR-0 Whole country SPF BPR, BPP, DOR, DOC, HEP, HER, SRA, SRP A S2 EP, E, POU, RAT, WGM IL — Israel IL-0 Whole country SPF BPR, BPP, DOC, DOR, HEP, HER, SRP A S1 WGM VIII EP, E, POU, RAT S4 IN — India IN-0 Whole country EP IS — Iceland IS-0 Whole country SPF EP, E S4 KR — Republic of Korea KR-0 Whole country EP, E S4 ME — Montenegro ME-O Whole country EP MG — Madagascar MG-0 Whole country SPF EP, E, WGM S4 MY – Malaysia MY-0 — — MY-1 Western Peninsular EP E P2 6.2.2004 S4 MK — former Yugoslav Republic of Macedonia (4) MK-0 (4) Whole country EP MX — Mexico MX-0 Whole country SPF EP NA — Namibia NA-0 Whole country SPF BPR I DOR II HER III RAT, EP, E VII S4 NC — New Caledonia NC-0 Whole country EP NZ — New Zealand NZ-0 Whole country SPF BPR, BPP, DOC, DOR, HEP, HER, SRA, SRP S0 WGM VIII EP, E, POU, RAT S4 PM — Saint Pierre and Miquelon PM-0 Whole territory SPF RS – Serbia (5) RS-0 (5) Whole country EP RU — Russian Federation RU-0 Whole country EP SG — Singapore SG-0 Whole country EP TH — Thailand TH-0 Whole country SPF, EP WGM VIII P2 23.1.2004 E, POU, RAT P2 23.1.2004 S4 TN — Tunisia TN-0 Whole country SPF DOR, BPR, BPP, HER S1 WGM VIII EP, E, POU, RAT S4 TR — Turkey TR-0 Whole country SPF E, EP S4 US — United States US-0 Whole country SPF BPR, BPP, DOC, DOR, HEP, HER, SRA, SRP A S3 WGM VIII EP, E, POU, RAT S4 UY — Uruguay UY-0 Whole country SPF EP, E, RAT S4 ZA — South Africa ZA-0 Whole country SPF EP, E S4 BPR I A DOR II HER III RAT VII ZW — Zimbabwe ZW-0 Whole country RAT VII EP, E S4 (1) Commodities, including those transported on the high seas, produced before this date may be imported into the Community during a period of 90 days from this date. (2) Only commodities produced after this date may be imported into the Community. (3) In accordance with the agreement between the European Community and the Swiss Confederation on trade in agricultural products (OJ L 114, 30.4.2002, p. 132). (4) The former Yugoslav Republic of Macedonia; provisional code that does not prejudge in any way the definitive nomenclature for this country, which will be agreed following the conclusion of negotiations currently taking place on this subject in the United Nations. (5) Not including Kosovo, as defined by United Nations Security Council Resolution 1244 of 10 June 1999.

▼B

PART 2

Model veterinary certificates

Model(s):

‘BPP’ : Model veterinary certificate for breeding or productive poultry other than ratites

‘BPR’ : Model veterinary certificate for breeding or productive ratites

‘DOC’ : Model veterinary certificate for day-old chicks other than of ratites

‘DOR’ : Model veterinary certificate for day-old chicks of ratites

‘HEP’ : Model veterinary certificate for hatching eggs of poultry other than ratites

‘HER’ : Model veterinary certificate for hatching eggs of ratites

‘SPF’ : Model veterinary certificate for specified pathogen-free eggs

‘SRP’ : Model veterinary certificate for slaughter poultry and poultry for restocking game supplies other than ratites

‘SRA’ : Model veterinary certificate for slaughter ratites

‘POU’ : Model veterinary certificate for meat of poultry

‘POU-MI/MSM’ : Model veterinary certificate for minced meat and mechanically separated meat of poultry

‘RAT’ : Model veterinary certificate for meat of farmed ratites for human consumption

‘RAT-MI/MSM’ : Model veterinary certificate for minced meat and mechanically separated meat of farmed ratites for human consumption

‘WGM’ : Model veterinary certificate for wild game-bird meat

‘WGM-MI/MSM’ : Model veterinary certificate for wild game-bird minced meat and mechanically separated meat

‘E’ : Model veterinary certificate for eggs

‘EP’ : Model veterinary certificate for egg products

Additional guarantees (AG):

‘I’ : Guarantees for breeding and productive ratites coming from a third country, territory or zone not free from Newcastle disease, certified in accordance with model BPR

‘II’ : Guarantees for day-old chicks of ratites coming from a third country, territory or zone not free from Newcastle disease, certified in accordance with model DOR

‘III’ : Guarantees for hatching eggs of ratites coming from a third country, territory or zone not free from Newcastle disease certified in accordance with model HER

▼M1 —————

▼B

‘V’ : Guarantees for slaughter ratites coming from a third country, territory or zone not free from Newcastle disease, certified in accordance with model SRA

‘VI’ : additional guarantees covering poultrymeat certified in accordance with model POU

‘VII’ : additional guarantees covering meat of farmed ratites for human consumption certified in accordance with model RAT

‘VIII’ : additional guarantees for wild game-bird meat certified in accordance with model WGM

▼M1

Salmonella control programme:

‘S0’ Prohibition to export into the Community breeding or productive poultry (BPP) of Gallus gallus, day-old chicks (DOC) of Gallus gallus, slaughter poultry and poultry for restocking (SRP) of Gallus gallus and hatching eggs (HEP) of Gallus gallus because a relevant Salmonella control programme in accordance with Regulation (EC) No 2160/2003 has not been submitted to the Commission or approved by it.

‘S1’ Prohibition to export into the Community breeding or productive poultry (BPP) of Gallus gallus, day-old chicks (DOC) of Gallus gallus and slaughter poultry and poultry for restocking (SRP) of Gallus gallus for other purposes than breeding, because a relevant Salmonella control programme in accordance with Regulation (EC) No 2160/2003 has not been submitted to the Commission or approved by it.

‘S2’ Prohibition to export into the Community breeding or productive poultry (BPP) of Gallus gallus, day-old chicks (DOC) of Gallus gallus and slaughter poultry and poultry for restocking (SRP) of Gallus gallus for other purposes than breeding or laying, because a relevant Salmonella control programme in accordance with Regulation (EC) No 2160/2003 has not been submitted to the Commission or approved by it.

‘S3’ Prohibition to export into the Community breeding or productive poultry (BPP) of Gallus gallus and slaughter poultry and poultry for restocking (SRP) of Gallus gallus for other purposes than breeding, because a relevant Salmonella control programme in accordance with Regulation (EC) No 2160/2003 has not been submitted to the Commission or approved by it.

‘S4’ Prohibition to export into the Community eggs (E) of Gallus gallus others than eggs classed B in accordance with Regulation (EC) No 557/2007 because a relevant Salmonella control programme in accordance with Regulation (EC) No 2160/2003 has not been submitted to the Commission or approved by it.

▼B

Specific conditions:

‘P2’ : Prohibition to import into or transit through the Community due to restrictions related to a HPAI outbreak

‘P3’ : Prohibition to import into or transit through the Community due to restrictions related to a ND outbreak

Avian influenza surveillance programme and avian influenza vaccination plan:

‘A’ : Third country, territory, zone or compartment carries out an avian influenza surveillance programme in accordance with Regulation (EC) No 798/2008

‘B’ : Third country, territory, zone or compartment carries out vaccination against avian influenza in accordance with Regulation (EC) No 798/2008

Notes

General notes:

(a) Veterinary certificates based on the models in Part 2 of this Annex and following the layout of the model that corresponds to the commodity concerned shall be issued by the exporting country, territory, zone or compartment. They shall contain, in the order appearing in the model, the attestations that are required for any third country and, where applicable, those additional health requirements required for the exporting country, territory, zone or compartment. Where additional guarantees are required by the EU Member State of destination for the commodity concerned, these shall also be entered on the original of the veterinary certificate.

(b) A separate, single certificate must be presented for each consignment of the commodity concerned, exported to the same destination from a territory appearing in columns 2 and 3 of Part 1 of this Annex and transported in the same railway wagon, lorry, aircraft or ship.

(c) The original of certificates shall consist of a single page printed on both sides or, where more text is required, such that all the pages form a whole and cannot be separated.

(d) The certificate shall be drawn up in at least one official language of the EU Member State where the border inspection takes place and in one official language of the EU Member State of destination. However, those Member States may allow another Community language instead of their own, accompanied, if necessary, by an official translation.

(e) Where additional pages are attached to the certificate for the purposes of identifying the items making up the consignment, such additional pages shall also be considered to form part of the original of the certificate, provided the signature and stamp of the certifying official veterinarian appear on each page.

(f) Where the certificate, including any additional pages as provided for in (e), comprises more than one page, each page shall be numbered ‘–x(page number) of y(total number of pages)–’ on the bottom and shall bear the code number of the certificate allocated by the competent authority on the top.

(g) The original of the certificate must be completed and signed by an official veterinarian not more than 24 hours prior to loading of the consignment for imports to the Community, unless otherwise stated. To that end, the competent authorities of the exporting country shall ensure that principles of certification equivalent to those laid down in Directive 96/93/EC are followed. The colour of the signature shall be different from that of the printing. The same rule shall apply to stamps other than embossed stamps or watermarks.

(h) The original of the certificate must accompany the consignment as far as the EU border inspection post.

Additional notes for poultry and day-old chicks:

(i) The certificate shall be valid for 10 days from the date of issue, unless otherwise stated. In the case of transport by ship, the term of validity shall be extended by the time taken by the voyage. To that end, the original of a declaration by the ship's master, drawn up in accordance with Annex II, shall be attached to the veterinary certificate.

(j) Poultry and day-old chicks shall not be transported with other poultry and day-old chicks that are either not intended for the European Community or of a lower health status.

(k) Poultry and day-old chicks shall not in the course of transport to the Community be moved through nor unloaded in a third country, territory, zone or compartment from which imports of such poultry and day-old chicks into the Community are not authorised.

Model veterinary certificate for breeding or productive poultry other than ratites (BPP)

Model veterinary certificate for breeding or productive ratites (BPR)

▼M2

Model veterinary certificate for day-old chicks other than of ratites (DOC)

▼B

Model veterinary certificate for day-old chicks of ratites (DOR)

▼M2

Model veterinary certificate for hatching eggs of poultry other than ratites (HEP)

▼B

Model veterinary certificate for hatching eggs of ratites (HER)

Model veterinary certificate for specified pathogen-free eggs (SPF)

▼M1

Model veterinary certificate for slaughter poultry and poultry for restocking game supplies other than ratites (SRP)

▼B

Model veterinary certificate for slaughter ratites (SRA)

Model veterinary certificate for meat of poultry (POU)

Model veterinary certificate for minced meat and mechanically separated meat of poultry (POU-MI/MSM)

(Not yet established)

Model veterinary certificate for meat of farmed ratites for human consumption (RAT)

Model veterinary certificate for minced meat and mechanically separated meat of farmed ratites for human consumption (RAT-MI/MSM)

(Not yet established)

Model veterinary certificate for wild game-bird meat (WGM)

Model veterinary certificate for wild game-bird minced meat and mechanically separated meat (WGM-MI/MSM)

(Not yet established)

Model veterinary certificate for eggs (E)

▼M2

Model veterinary certificate for egg products (EP)

▼B









ANNEX II

(as referred to in Article 4)

(To be completed and attached to the veterinary certificate where transport of poultry and day-old chicks to the European Community border includes transport by ship, even for part of the journey.)









ANNEX III

COMMUNITY ACTS, INTERNATIONAL STANDARDS AND PROCEDURES FOR EXAMINATION, SAMPLING AND TESTING AS REFERRED TO IN ARTICLE 6

I. Before import into the Community

Methods for standardisation of materials and procedures for examination, sampling and testing for:

1. Avian influenza — Diagnostic manual for avian influenza as laid down in Commission Decision 2006/437/EC ( 21 ); or — Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for animal Health (OIE) ( 22 ).

2. Newcastle disease — Annex III to Council Directive 92/66/EEC ( 23 ); or — Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for animal Health (OIE); — Where Article 12 of Directive 90/539/EEC applies, the sampling and testing methods must comply with the methods described in Annexes to Commission Decision 92/340/EEC ( 24 ).

3. Salmonella pullorum and Salmonella gallinarum — Chapter III of Annex II to Directive 90/539/EEC; or — Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for animal Health (OIE).

▼M2

4. Salmonella arizonae — Chapter III of Annex II to Directive 90/539/EEC; or — Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for animal Health (OIE).

▼B

5. Mycoplasma gallisepticum — Chapter III of Annex II to Directive 90/539/EEC; or — Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for animal Health (OIE).

6. Mycoplasma meleagridis Chapter III of Annex II to Directive 90/539/EEC.

7. Salmonella of public health significance The detection method recommended by the Community reference laboratory (CRL) for Salmonella in Bilthoven, the Netherlands, or an equivalent method shall be used. That method is described in the current version of draft Annex D of ISO 6579 (2002): ‘Detection of Salmonella spp. in animal faeces and in samples of the primary production stage’. In that detection method, a semi-solid medium (modified semi-solid Rappaport-Vassiladis medium, MSRV) is used as the single selective enrichment medium. Serotyping shall be carried out following the Kauffmann-White scheme or an equivalent method.

II. After import into the Community

Sampling and testing procedures for avian influenza and Newcastle disease:

During the period referred to in point II.1 of Annex VIII, the official veterinarian shall take samples from the imported poultry for virological examination, to be tested as follows:

— Between the seventh and the fifteenth day following the date of commencement of the isolation period, cloacal swabs must be taken from all birds where the consignment contains less than 60 birds, and from at least 60 birds where consignments contain more than 60 birds;

— Testing of samples must be carried out in official laboratories designated by the competent authority, using diagnostic procedures for: — (i) avian influenza as laid down in the diagnostic manual in Commission Decision 2006/437/EC; (ii) Newcastle disease as laid down in Annex III to Council Directive 92/66/EEC.

III. General requirements

— Samples may be pooled, subject to a maximum of five samples from individual birds in each pool.

— Virus isolates must be sent without delay to the national reference laboratory.









ANNEX IV

(as referred to in Article 8(2)(d), Article 9(2)(b) and Article 10

REQUIREMENTS FOR AVIAN INFLUENZA SURVEILLANCE PROGRAMMES AND INFORMATION TO BE SUBMITTED ( 25 )

I. Requirements for avian influenza surveillance in poultry carried out in third countries, territories, zones or compartments as referred to in Article 10.

A. surveillance for avian influenza in poultry:

1. Description of objectives

2. Third country, territory, zone or compartment (keep as appropriate):

3. Type of surveillance: — Serological surveillance — Virological surveillance — Targeted avian influenza subtypes

4. Sampling criteria: — Targeted species (for example, turkeys, chicken, partridges) — Targeted categories (for example, breeders, layers) — Targeted husbandry systems (for example, commercial establishments, backyard flocks)

5. Statistical basis for number of establishments sampled: — Number of establishments in area — Number of establishments per category — Number of establishments to be sampled per poultry category

6. Frequency of sampling

7. Number of samples taken per establishment/shed

8. Time period for sampling

9. Type of samples taken (tissue, faeces, cloacal/oropharyngeal/tracheal swabs)

10. Laboratory tests used (for example, AGID, PCR, HI, Virus isolation.)

11. Indication of laboratories carrying out testing at central, regional or local level (keep as appropriate) Indication of reference laboratory carrying out confirmatory testing (avian influenza national reference laboratory, OIE or Community reference laboratory for avian influenza)

12. Reporting system/protocol used for avian influenza surveillance results (include results where available)

13. Follow-up investigations of positive results for subtypes H5 and H7.

B. where available information on surveillance for avian influenza in wild birds to assess risk factors for avian influenza introduction into poultry:

1. Type of surveillance: — Serological surveillance — Virological surveillance — Targeted avian influenza subtypes

2. Sampling criteria

3. Targeting of wild bird species (indicate species names in Latin)

4. Targeting of selected areas

5. Information referred to in point 6 and points 8 to 12 of Part I.A.

II. Avian influenza surveillance to be carried out following the occurrence of an outbreak of that disease in a third country, territory, zone or compartment previously free from that disease, as referred to in Articles 8(2)(d) and 9(2)(b)

Surveillance for avian influenza must provide at least the confidence by a randomised representative sample of the populations at risk to demonstrate the absence of infection taking into account the specific epidemiological circumstances in relation to the occurred outbreak(s).









ANNEX V

(as referred to in Article 11(a))

INFORMATION TO BE SUBMITTED BY A THIRD COUNTRY VACCINATING AGAINST AVIAN INFLUENZA ( 26 )

I. Requirements for vaccination plans carried out in a third country, territory, zone or compartment as referred to in Article 11

1. Country, territory, zone or compartment (keep as appropriate)

2. Disease history (previous outbreaks in poultry or cases in wild birds of HPAI/LPAI)

3. Description of the reasons for the decision on the introduction of vaccination

4. 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

5. Geographical area where vaccination is carried out

6. Number of establishments in vaccination area

7. Number of establishments where vaccination is carried out, if different from number in point 6

8. Species and categories of poultry or other captive birds in vaccination territory, zone or compartment

9. Approximate number of poultry or other captive birds in the establishments referred to in point 7

10. Summary of the vaccine characteristics

11. Authorisation, handling, manufacture, storage, supply, distribution and sale of avian influenza vaccines on national territory

12. Implementation of a DIVA strategy

13. Envisaged duration of vaccination campaign

14. Provisions and restrictions on the movements of vaccinated poultry and poultry products derived from vaccinated poultry or vaccinated other captive birds

15. 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.)

16. Means of record keeping (e.g. for the detailed information referred to point 15) and registration of holdings where vaccination is carried out.

II. 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) and (2)(c)(ii) and Article 13(1)(a))

CRITERIA FOR RECOGNISED NEWCASTLE DISEASE VACCINES

I. General criteria

1. 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 must rely on a complete file containing data about efficacy and innocuity; 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 internationally accepted standards.

2. In addition, imports or production and distribution of the vaccines must be controlled by the competent authorities of the third country concerned.

3. 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.

II. Specific criteria

1. Live Newcastle disease vaccines shall 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 either: (i) less than 0,4, if not less than 107 EID50 are administered to each bird in the ICPI test; or (ii) less than 0,5, if not less than 108 EID50 are administered to each bird in the ICPI test.

2. Inactivated Newcastle disease vaccines shall be prepared from a Newcastle disease virus strain with an intracerebral pathogenicity index (ICPI) in one-day-old chicks of less than 0,7, 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

I. 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.

2. 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).

II. For meat of poultry

Meat of poultry must come from slaughter poultry that:

(a) has not been vaccinated with vaccines prepared from a Newcastle disease virus master seed showing a higher pathogenicity than lentogenic strains of the virus within 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

I. 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 90/539/EEC 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 3mm 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.

5. 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.

II. 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.

2. 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 90/539/EEC) and kept there for at least three weeks from the date of hatching.

3. 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.

4. 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.

5. 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

I. 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.

4. 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.

II. 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.

3. 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.

4. 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.

5. 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.

6. 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.

IV. 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 90/539/EEC, 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

I. 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 antibodies 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.

II. 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.

▼M2









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

▼B









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