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Document 32013R0139

Commission Implementing Regulation (EU) No 139/2013 of 7 January 2013 laying down animal health conditions for imports of certain birds into the Union and the quarantine conditions thereof (codification) (Text with EEA relevance)

OJ L 47, 20.2.2013, p. 1–17 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
Special edition in Croatian: Chapter 03 Volume 062 P. 318 - 334

Legal status of the document No longer in force, Date of end of validity: 20/04/2021; Repealed by 32020R0692

ELI: http://data.europa.eu/eli/reg_impl/2013/139/oj

20.2.2013   

EN

Official Journal of the European Union

L 47/1

COMMISSION IMPLEMENTING REGULATION (EU) No 139/2013

of 7 January 2013

laying down animal health conditions for imports of certain birds into the Union and the quarantine conditions thereof

(codification)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

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 (1), and in particular the second subparagraph of Article 10(3) and point (b) of second subparagraph of Article 10(4) thereof,

Having regard to Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(I) to Directive 90/425/EEC (2), and in particular Article 17(2)(b) and Article 17(3) and the first and fourth indents of Article 18(1) thereof,

Whereas:

(1)

Commission Regulation (EC) No 318/2007 of 23 March 2007 laying down animal health conditions for imports of certain birds into the Community and the quarantine conditions thereof (3) has been substantially amended several times (4). In the interests of clarity and rationality the said Regulation should be codified.

(2)

Following the outbreaks of highly pathogenic avian influenza of the Asian lineage in South-East Asia in 2004, the Commission adopted several Decisions banning amongst other commodities the import of birds, other than poultry, from affected third countries.

(3)

In order to draw up an inventory of the risks posed by the import of captive birds, the Commission on 13 April 2005 requested the European Food Safety Authority (EFSA) to provide a scientific opinion on the risks posed by imports of birds caught in the wild and captive bred birds from third countries.

(4)

Following that request, the EFSA Panel on animal health and welfare adopted, during their meeting of 26 and 27 October 2006, a Scientific Opinion on the Animal Health and Welfare risks associated with the import of wild birds, other than poultry, into the Union. That Scientific Opinion identifies possible tools and options which can reduce any identified animal health risk related to imports of birds other than poultry.

(5)

One of the recommendations of the EFSA Scientific Opinion relates to controls carried out in the third countries exporting birds, other than poultry, to the Union. Improvements at the point of export should have most impact in reducing the probability that infected birds are presented for entry into the Union. For that reason, import conditions should be laid down in this Regulation in such a way that only imports from third countries authorised for imports into the Union of such birds are allowed.

(6)

Another EFSA recommendation relates to imports of birds caught in the wild. The Scientific Opinion identifies the risk caused by those birds that may be infected due to lateral spread from other infected wild birds and from the contaminated environment, as well as overspill from infected poultry. Taking into account the role played by wild migratory birds in the spread of avian influenza from Asia to Europe in 2005 and 2006, it is appropriate to limit imports of birds, other than poultry, only to birds bred in captivity.

(7)

It is seldom possible to distinguish with certainty between birds that have been caught in the wild and captive bred birds. Methods of marking can be applied to both types of birds without it being possible to distinguish between them. It is therefore appropriate to limit imports of birds, other than poultry, to breeding establishments that are approved by the competent authority of the third country of export, and to lay down certain minimum conditions for such approval.

(8)

The imported birds should be transported directly to an approved quarantine facility or centre in a Member State, where they should remain until infection with avian influenza or Newcastle disease virus is ruled out.

(9)

In case avian influenza or Newcastle disease is suspected in an approved quarantine facility or in a unit of an approved quarantine centre, it is appropriate to wait until the suspicion is confirmed to rule out any other cause of disease symptoms before commencing to kill and destroy the birds in the affected premises.

(10)

Council Directive 2005/94/EC of 20 December 2005 on Community measures for the control of avian influenza and repealing Directive 92/40/EEC (5) was adopted to take account of the experience gained in the control of avian influenza. Based on that Directive, Commission Decision 2006/437/EC of 4 August 2006 approving a Diagnostic Manual for avian influenza as provided for in Council Directive 2005/94/EC (6) (the diagnostic manual) was adopted laying down at Union level diagnostic procedures, sampling methods and criteria for the evaluation of the results of laboratory tests for the confirmation of an outbreak of avian influenza. Account should be taken of that Decision as regards the testing regimes for avian influenza in approved quarantine facilities and centres.

(11)

It is appropriate to lay down further import procedures relating to the transfer from the border inspection post to the approved quarantine facilities or centres upon entry into the Union in order to ensure that imported birds arrive at the designated approved quarantine facility or centre within a reasonable time period.

(12)

Approved quarantine facilities and centres, the list of which is to be published by Member States, should comply with certain minimum conditions.

(13)

Certain imports of birds are covered by other Union legislation. Therefore, they should be excluded from the scope of this Regulation.

(14)

The animal health risk posed by racing pigeons that are brought into the Union to be released again so that they may fly back to their origin is such that they should be excluded from the scope of this Regulation.

(15)

In addition, certain third countries have animal health conditions that are equivalent to those provided for in Union legislation. Therefore, imports of birds from those countries should be excluded from the scope of this Regulation.

(16)

Certain derogations should also be considered for those birds found to be infected with low pathogenic avian influenza and Newcastle disease in an approved quarantine facility or centre, in those cases where the occurrence of disease does not pose a risk to the animal health status of the Union.

(17)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter

This Regulation lays down the animal health conditions for imports of certain birds into the Union, from the third countries and parts thereof referred to in Annex I, and the quarantine conditions for such imports.

Article 2

Scope

This Regulation shall apply to animals of the avian species.

However, it shall not apply to:

(a)

poultry;

(b)

birds imported for conservation programmes approved by the competent authority in the Member State of destination;

(c)

pet animals referred to in the third paragraph of Article 1 of Directive 92/65/EEC, accompanying their owner;

(d)

birds intended for zoos, circuses, amusement parks or experiments;

(e)

birds destined for bodies, institutes or centres approved according to Article 13 of Directive 92/65/EEC;

(f)

racing pigeons which are introduced to the territory of the Union from a neighbouring third country where they are normally resident and then immediately released with the expectation that they will fly back to that third country;

(g)

birds imported from Andorra, Liechtenstein, Monaco, Norway, San Marino, Switzerland, and the Vatican City State.

Article 3

Definitions

For the purposes of this Regulation, the definitions of Directive 2005/94/EC shall apply except for the definition of poultry in point 4 of Article 2 of that Directive. For the purposes of this Regulation ‘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.

The following definitions shall also apply:

(a)

‘birds’ means animals of the avian species other than those referred to in the second paragraph of Article 2;

(b)

‘approved breeding establishment’ means:

(i)

an establishment used exclusively for the breeding of birds; and

(ii)

that has been inspected and approved by the competent authority of the exporting third country for compliance with the conditions provided for in Article 4 and Annex II;

(c)

‘captive bred birds’ means birds that have not been caught in the wild but have been born and bred in captivity from parents that mated or had gametes otherwise transferred in captivity;

(d)

‘seamlessly closed leg-ring’ means a ring or band in a continuous circle, without any break or join, which has not been tampered with in any way, of a size which cannot be removed from the bird when its leg is fully grown after having been applied in the first days of the bird’s life and which has been commercially manufactured for that purpose;

(e)

‘approved quarantine facility’ means premises, other than quarantine centres:

(i)

in which quarantine of imported birds is carried out;

(ii)

which has been inspected and approved by the competent authority for compliance with the minimum conditions provided for in Article 6 and Annex IV;

(f)

‘approved quarantine centre’ means premises:

(i)

in which quarantine of imported birds is carried out;

(ii)

containing a number of units, which are operationally and physically separated from each other and in which each unit contains only birds of the same consignment, with the same health status, and therefore comprises a single epidemiological unit;

(iii)

which has been inspected and approved by the competent authority for compliance with the minimum conditions provided for in Article 6 and Annex IV;

(g)

‘sentinel birds’ means poultry which are to be used as a diagnostic aid during quarantine;

(h)

‘diagnostic manual’ means the Diagnostic Manual for avian influenza set out in the Annex to Decision 2006/437/EC.

Article 4

Approved breeding establishments

Approved breeding establishments shall comply with the following conditions:

(a)

the breeding establishment must be approved by the competent authority in accordance with the conditions set out in Annex II, and assigned an approval number;

(b)

that approval number must have been communicated to the Commission by that authority;

(c)

the name and approval number of the breeding establishment must appear on a list of breeding establishments drawn up by the Commission;

(d)

the approval of the breeding establishment must be immediately withdrawn or suspended by the competent authority where it no longer complies with the conditions set out in Annex II and the Commission must be immediately informed thereof.

Article 5

Import conditions

Imports of birds shall be authorised only if the birds comply with the following conditions:

(a)

the birds are captive bred birds;

(b)

the birds must originate from third countries or parts thereof referred to in Annex I;

(c)

the birds come from approved breeding establishments that comply with the conditions laid down in Article 4;

(d)

the birds were subjected to a laboratory virus detection test 7 to 14 days prior to shipment with negative results for any avian influenza and Newcastle disease virus;

(e)

the birds have not been vaccinated against avian influenza;

(f)

the birds are accompanied by an animal health certificate in accordance with the model set out in Annex III (the animal health certificate);

(g)

the birds are identified with an individual identification number by means of a uniquely marked seamlessly closed leg-ring or a microchip in accordance with Article 66(2) of Commission Regulation (EC) No 865/2006 (7);

(h)

the individual identification number of leg-rings or microchips provided for in point (g) must contain at least the following:

—

the ISO code of the exporting third country performing the identification,

—

a unique serial number;

(i)

the individual identification number provided for in point (g) must be registered on the animal health certificate;

(j)

the birds are transported in new containers which are individually identified externally with an identification number that must correspond with the identification number indicated on the animal health certificate.

Article 6

Approved quarantine facilities and centres

Approved quarantine facilities and centres shall comply with the minimum conditions set out in Annex IV.

Each Member State shall draw up and keep up to date a list of approved quarantine facilities and centres and their approval numbers and make it available to the Commission, to the other Member States and to the public.

Article 7

Direct transport of birds to approved quarantine facilities or centres

Birds shall be transported directly from the border inspection post to an approved quarantine facility or centre in cages or crates.

The total journey time from that post to that quarantine facility or centre must not normally exceed nine hours.

When vehicles are used for this journey they shall be sealed by the competent authorities with a tamper proof seal.

Article 8

Attestation

Importers or their agents shall provide a written attestation, in an official language of the Member State of entry, and signed by the person responsible for the quarantine facility or centre certifying that the birds will be accepted for quarantine.

That attestation shall:

(a)

clearly indicate the name and address and approval number of the quarantine facility or centre;

(b)

reach the border inspection post via e-mail or fax prior to time of arrival of the consignment at that post or shall be presented by the importer or his agent before the birds are released from the border inspection post.

Article 9

Transit of birds in the Union

Where birds are introduced into the Union via a Member State other than that of destination, all measures shall be taken to ensure that the consignment reaches the intended Member State of destination.

Article 10

Monitoring of the transport of birds

1.   Where Union legislation provides for the monitoring of birds from the border inspection post to the approved quarantine facility or centre at the place of destination, the following exchanges of information shall be provided:

(a)

the official veterinarian responsible for the border inspection post shall notify the competent authority responsible for the approved quarantine facility or centre at the place of destination of the consignment, of the place of origin and the place of destination of the birds via the Traces network;

(b)

the person responsible for the approved quarantine facility or centre of destination shall notify by e-mail or fax, within one working day of the date of arrival of the consignment at the quarantine facility or centre, the official veterinarian responsible for the approved quarantine facility or centre at the place of destination of the arrival of the consignment at its destination;

(c)

the official veterinarian responsible for the approved quarantine facility or centre at the place of destination of the consignment shall notify via the Traces network, within three working days of the date of arrival of the consignment at the quarantine facility or centre, the official veterinarian responsible for the border inspection post who notified him of the shipment of the consignment of the arrival of the consignment at its destination.

2.   If confirmation is provided to the competent authority responsible for the border inspection post, that the birds declared as being intended for an approved quarantine facility or centre have not arrived at their destination within three working days of the estimated date of arrival of the consignment at the quarantine facility or centre, the competent authority shall take appropriate measures vis-à-vis the person responsible for the consignment.

Article 11

Quarantine provisions

1.   The birds shall be quarantined for at least 30 days in an approved quarantine facility or centre (‘the quarantine’).

2.   At least at the beginning and the end of quarantine of each consignment, the official veterinarian shall inspect the conditions of quarantine, including an examination of the mortality records and a clinical inspection of the birds in the approved quarantine facility or in each unit of the approved quarantine centre.

However, the official veterinarian shall carry out inspections more frequently if required by the disease situation.

Article 12

Examination, sampling and testing to be carried out in relation to a consignment during quarantine

1.   The examination, sampling and testing procedures for avian influenza and Newcastle disease, set out in Annex V, shall be carried out following the arrival of the birds in quarantine.

2.   When sentinel birds are used a minimum of 10 sentinel birds shall be used in the approved quarantine facility or in each unit of the approved quarantine centre.

3.   Sentinel birds used for examination, sampling and testing procedures shall be:

(a)

at least three weeks old and used only once for those purposes;

(b)

leg-banded for identification purposes or identified with another non-removable identification;

(c)

unvaccinated and have been found sero-negative for avian influenza and Newcastle disease within a period of 14 days before the date of commencement of quarantine;

(d)

placed in the approved quarantine facility or in a unit of the approved quarantine centre before the arrival of the birds in the common airspace and as close as possible to the birds in such a way that close contact between the sentinel birds and the excrements of the birds in quarantine is ensured.

Article 13

Action in case of a suspected disease in an approved quarantine facility or centre

1.   If during quarantine in an approved quarantine facility, it is suspected that one or more birds and/or sentinel birds are infected with avian influenza or Newcastle disease, the following measures shall be taken:

(a)

the competent authority shall place the approved quarantine facility under official supervision;

(b)

samples for virological examination as set out in point 2 of Annex V shall be taken from those birds and sentinel birds and shall be analysed accordingly;

(c)

no birds shall enter or leave the approved quarantine facility until the suspicion is ruled out.

2.   If the suspicion of avian influenza or Newcastle disease in the affected approved quarantine facility as referred to in paragraph 1 is confirmed, the following measures shall be taken:

(a)

all birds and sentinel birds in the approved quarantine facility shall be killed and destroyed;

(b)

the approved quarantine facility shall be cleaned and disinfected;

(c)

no birds shall enter the approved quarantine facility until 21 days following the final cleaning and disinfection.

3.   If during quarantine in an approved quarantine centre, it is suspected that one or more birds and/or sentinel birds in a unit of the quarantine centre are infected with avian influenza or Newcastle disease, the following measures shall be taken:

(a)

the competent authority shall place the approved quarantine centre under official supervision;

(b)

samples for virological examination as set out in point 2 of Annex V shall be taken from those birds and sentinel birds and shall be analysed accordingly;

(c)

no birds shall enter or leave the approved quarantine centre until the suspicion is ruled out.

4.   If the suspicion of avian influenza or Newcastle disease in the affected unit of the approved quarantine centre as referred to in paragraph 3 is confirmed, the following measures shall be taken:

(a)

all birds and sentinel birds in the affected unit of the approved quarantine centre shall be killed and destroyed;

(b)

the unit concerned shall be cleaned and disinfected;

(c)

the following samples shall be taken:

(i)

where sentinel birds are used, not earlier than 21 days following the final cleaning and disinfection of the unit concerned, samples for serological examination as set out in Annex V must be taken from sentinel birds in the other quarantine units; or

(ii)

where no sentinel birds are used, during 7 to 15 days following the final cleaning and disinfection, samples for virological examination as set out in point 2 of Annex V must be taken from birds in the other quarantine units;

(d)

no birds shall leave the approved quarantine centre until the results of the sampling provided for in point (c) have been confirmed as negative.

5.   Member States shall inform the Commission of any measures taken under this Article.

Article 14

Derogations relating to a positive finding of low pathogenic avian influenza or Newcastle disease in an approved quarantine facility or centre

1.   Where during quarantine one or more birds and/or sentinel birds are found to be infected with low pathogenic avian influenza (LPAI) or Newcastle disease, the competent authority may, based on a risk assessment, grant derogations from the measures provided for in Article 13(2)(a) and (4)(a), provided that such derogations do not endanger disease control (the derogation).

Member States shall immediately inform the Commission of any such derogations.

2.   When an official veterinarian inspects an approved quarantine facility or centre that has been granted a derogation, and one or more of the birds and/or sentinel birds are found to be infected with LPAI or Newcastle disease, the measures set out in paragraphs 3 to 7 shall be complied with.

Member States shall immediately inform the Commission of any such measures.

3.   In the case of a positive finding of LPAI, instead of the standard samples as provided for in the diagnostic manual, the following samples shall be taken for laboratory testing, 21 days following the date of the last positive finding of LPAI in the approved quarantine facility or from each unit in the approved quarantine centre and at intervals of 21 days:

(a)

samples of any dead sentinel birds or other birds present at the time of sampling;

(b)

tracheal/oropharyngeal and cloacal swabs from at least 60 birds or from all birds where there are less than 60 present at the approved quarantine facility or the unit concerned of the approved quarantine centre; or if the birds are small, exotic and not used to being handled or handling them would be dangerous for people, samples of fresh faeces must be collected; the sampling and laboratory testing of such samples must continue until two consecutive negative laboratory results are obtained which must be at least at an interval of 21 days.

However, the competent authority may grant derogations from the sample size provided for in this paragraph, based on the outcome of a risk assessment.

4.   In the case of a positive finding of Newcastle disease, the competent authority may only grant a derogation provided that in the 30 days following the death or clinical recovery of the last case of that disease, sampling in accordance with points 1 and 2 of Annex V, not taking account of the reference to the time period specified, has been carried out with negative results.

5.   Birds shall not be released from quarantine until at least the laboratory testing period provided for in paragraph 3 has elapsed.

6.   The approved quarantine facility or the unit concerned of the approved quarantine centre shall be cleaned and disinfected after it has been emptied. Any matter or waste likely to have been contaminated as well as all the waste that has accumulated during the laboratory testing period provided for in paragraph 3 shall be removed in such a way that ensures that the pathogen is not spread, and destroyed in such a way that guarantees the destruction of the virus of LPAI or Newcastle disease present.

7.   The repopulation of the approved quarantine facility or centre shall not take place for a period of 21 days following the date of completion of the final cleansing and disinfection as provided for in paragraph 6.

Article 15

Action in case of suspected Chlamydiosis

If during quarantine in an approved quarantine facility or centre, it is suspected or confirmed that psittaciformes are infected with Chlamydophila psittaci all birds of the consignment shall be treated by a method approved by the competent authority and the quarantine shall be prolonged for at least two months following the date of the last recorded case.

Article 16

Release from quarantine

Birds shall only be released from quarantine in an approved quarantine facility or centre on written authorisation by an official veterinarian.

Article 17

Notification and reporting requirements

1.   Member States shall communicate to the Commission within 24 hours any case of avian influenza or Newcastle disease detected in an approved quarantine facility or centre.

2.   Member States shall communicate to the Commission the following information on an annual basis:

(a)

the number of birds imported via approved quarantine facilities and centres per species and per approved breeding establishment of origin;

(b)

information regarding the mortality rate for imported birds from the animal health certification procedure in the country of origin to the end of the quarantine period;

(c)

the number of cases of positive findings of avian influenza, Newcastle disease and Chlamydophila psittaci in approved quarantine facilities or centres.

Article 18

Cost relating to quarantine

All quarantine costs incurred by the application of this Regulation shall be borne by the importer.

Article 19

Repeal

Regulation (EC) No 318/2007 is repealed.

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

Article 20

Entry into force

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

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

Done at Brussels, 7 January 2013.

For the Commission

The President

José Manuel BARROSO

(1)  OJ L 268, 24.9.1991, p. 56.

(2)  OJ L 268, 14.9.1992, p. 54.

(3)  OJ L 84, 24.3.2007, p. 7.

(4)  See Annex VI.

(5)  OJ L 10, 14.1.2006, p. 16.

(6)  OJ L 237, 31.8.2006, p. 1.

(7)  OJ L 166, 19.6.2006, p. 1.

ANNEX I

List of third countries from which imports of captive bred birds are authorised

1.

Third countries or parts thereof listed in columns 1 and 3 of the table in Part 1 of Annex I to Commission Regulation (EC) No 798/2008 (1), where column 4 of that table provides for a model veterinary certificate for breeding or productive poultry other than ratites (BPP);

2.

Argentina;

3.

Philippines: National Capital Region.

(1)  OJ L 226, 23.8.2008, p. 1.

ANNEX II

Conditions governing approval of breeding establishments in the third country of origin as provided for in Article 4

CHAPTER 1

Approval of breeding establishments

In order to be granted approval as provided for in Article 4, a breeding establishment shall comply with the conditions set out in this Chapter.

(1)

The breeding establishment must be clearly demarcated and separated from its surroundings or the animals confined and located so as not to pose a health risk to animal holdings whose health status might be jeopardised.

(2)

It must have adequate means for catching, confining and isolating animals and have available adequate approved quarantine facilities and approved procedures for animals coming from establishments that have not been approved.

(3)

The person responsible for the breeding establishment must have adequate experience in the breeding of birds.

(4)

The breeding establishment must be free of avian influenza, Newcastle disease and Chlamydophila psittaci; in order for it to be declared free from those diseases, the competent authority shall assess the records on the animal health status kept for at least the previous three years before the date of the application for approval and the results of the clinical and laboratory tests carried out on the animals therein. However, new breeding establishments shall only be approved on the results of the clinical and laboratory tests carried out on the animals in such establishments.

(5)

It must keep up-to-date records indicating:

(a)

the number and identity (age, sex, species and individual identification number where practical) of the animals of each species present in the breeding establishment;

(b)

the number and identity (age, sex, species and individual identification number where practical) of animals arriving in the breeding establishment or leaving it, together with information on their origin or destination, the transport from or to the breeding establishment and the animals health status;

(c)

the results of blood tests or any other diagnostic procedures;

(d)

cases of disease and, where appropriate, the treatment administered;

(e)

the results of the post-mortem examinations on animals that have died in the breeding establishment, including still-born animals;

(f)

observations made during any isolation or quarantine period.

(6)

The breeding establishment must either have an arrangement with a competent laboratory to perform post-mortem examinations, or have one or more appropriate premises where such examinations may be performed by a competent person under the authority of the approved veterinarian.

(7)

The breeding establishment must either have suitable arrangements or on-site facilities for the appropriate disposal of the bodies of animals which die of a disease or are euthanised.

(8)

The breeding establishment must secure, by contract or legal instrument, the services of a veterinarian approved by and under the control of the competent authority of the exporting third country, who:

(a)

shall ensure that appropriate disease surveillance and control measures in relation to the disease situation of the country concerned are approved by the competent authority and applied in the breeding establishment. Such measures shall include:

(i)

an annual disease surveillance plan including appropriate zoonoses control of the animals;

(ii)

clinical, laboratory and post-mortem testing of animals suspected to be affected by transmissible diseases;

(iii)

vaccination of susceptible animals against infectious diseases as appropriate, in conformity with the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (OIE);

(b)

shall ensure that any suspect deaths or the presence of any other symptoms suggesting that animals have contracted avian influenza, Newcastle disease or Chlamydophila psittaci is notified without delay to the competent authority of the third country;

(c)

shall ensure that animals entering the breeding establishment have been isolated as necessary, and in accordance with the requirements of this Regulation and the instructions, if any, given by the competent authority;

(d)

shall be responsible for the day to day compliance with the animal health requirements of this Regulation and of Union legislation on welfare of animals during transport.

(9)

If the breeding establishment breeds animals intended for laboratories carrying out experiments, the general care and accommodation of such animals must be in conformity with the requirements of Article 33 of Directive 2010/63/EU of the European Parliament and of the Council (1).

CHAPTER 2

Maintaining the approval of breeding establishments

Breeding establishments shall only remain approved as such if they comply with the conditions set out in this Chapter.

(1)

The premises are under the control of an official veterinarian from the competent authority, who shall:

(a)

ensure that the conditions set out in this Regulation are met;

(b)

visit the premises of the breeding establishment at least once per year;

(c)

audit the activity of the approved veterinarian and the implementation of the annual disease surveillance plan;

(d)

verify that the results of the clinical, post-mortem and laboratory tests on the animals have revealed no occurrence of avian influenza, Newcastle disease or Chlamydophila psittaci.

(2)

Only animals coming from another approved breeding establishment are introduced into the breeding establishment, in accordance with the conditions set out in this Regulation.

(3)

The breeding establishment shall keep the records referred to in point 5 of Chapter 1 following the date of approval, for a period of at least 10 years.

CHAPTER 3

Quarantine of birds introduced from other sources than approved breeding establishments

By way of derogation from point 2 of Chapter 2, birds introduced from sources other than approved breeding establishments, may be introduced in a breeding establishment after approval for such an introduction is given by the competent authority, provided that such animals undergo quarantine in accordance with the instructions given by the competent authority before being added to the collection. The quarantine period must be at least 30 days.

CHAPTER 4

Suspending, withdrawing or regranting approval of breeding establishments

The procedures for partly or completely suspending, withdrawing or regranting approval of breeding establishments shall comply with the conditions set out in this Chapter.

(1)

Where the competent authority finds that a breeding establishment no longer complies with the conditions set out in Chapters 1 and 2, or there has been a change of use so that it is no longer used exclusively for the breeding of birds, it shall suspend or withdraw the approval of such establishment.

(2)

Where the competent authority has received notification of the suspicion of avian influenza, Newcastle disease or Chlamydophila psittaci, it shall suspend the approval of the breeding establishment, until the suspicion has been officially ruled out. It shall ensure that the measures necessary to confirm or rule out the suspicion and to avoid any spread of disease are taken, in accordance with the requirements of Union legislation governing measures to be taken against the disease in question and on trade in animals.

(3)

Where the suspected disease is confirmed, the competent authority may only approve the breeding establishment again in accordance with Chapter 1 following:

(a)

the eradication of the disease and the source of infection in the breeding establishment;

(b)

the suitable cleaning and disinfection of the breeding establishment;

(c)

the fulfilling of the conditions laid down in Chapter 1, with the exception of point 4.

(4)

The competent authority shall immediately inform the Commission of the suspension, withdrawal or regranting of approval of any breeding establishment.

(1)  OJ L 276, 20.10.2010, p. 33.

ANNEX III

Animal health certificate as referred to in point (f) of article 5 for imports of certain birds other than poultry intended for dispatch to the Union

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ANNEX IV

Minimum conditions for approved quarantine facilities and centres for birds as referred to in article 6

Approved quarantine facilities and centres shall comply with the conditions set out in Chapters 1 and 2.

CHAPTER 1

Construction and equipment of quarantine facilities or centres

(1)

 The quarantine facility or centre must be a separate building or buildings which are separated from other poultry holdings and other bird holdings by a distance specified by the competent authority based on a risk assessment which takes into account the epidemiology of avian influenza and Newcastle disease. Entry/exit doors must be lockable with signs indicating: ‘QUARANTINE — No admission for unauthorised persons’.

(2)

 Each quarantine unit of the quarantine centre must occupy a separate airspace.

(3)

 The quarantine facility or centre must be bird, fly and vermin proof and sealable so as to permit fumigation.

(4)

 The approved quarantine facility and each unit of an approved quarantine centre must be equipped with hand washing facilities.

(5)

 Entry and exit doors to the approved quarantine facility and to each unit of an approved quarantine centre must be double door systems.

(6)

 Hygiene barriers must be installed at all entrances/exits to the approved quarantine facility and the different units of an approved quarantine centre.

(7)

 All equipment must be constructed in such a way that it can be cleaned and disinfected.

(8)

 The feed store must be bird and rodent proof and must be protected against insects.

(9)

 A container must be available to store litter and must be bird and rodent proof.

(10)

 A refrigerator and/or freezer must be provided for holding carcases.

CHAPTER 2

Management requirements

(1)

 Approved quarantine facilities and centres must:

(a)

have an efficient control system so as to ensure adequate surveillance of the animals;

(b)

be under the control and responsibility of the official veterinarian;

(c)

be cleaned and disinfected in accordance with a programme approved by the competent authority after which there shall be an appropriate resting period; the disinfectants used must be approved for that purpose by the competent authority.

(2)

 For each consignment of birds quarantined:

(a)

the approved quarantine facility or unit of an approved quarantine centre must be cleaned and disinfected and then be kept free of birds for at least seven days before the imported birds are introduced;

(b)

the consignment of birds must come from a single approved breeding establishment in the third country of origin and be introduced over a period of not more than 48 hours;

(c)

the quarantine period must start when the last bird is introduced;

(d)

the approved quarantine facility or unit of an approved quarantine centre must be emptied of birds, cleaned and disinfected at the end of the quarantine period.

(3)

 Precautions shall be taken to prevent cross-contamination between incoming and outgoing consignments.

(4)

 Unauthorised persons shall not enter the approved quarantine facility or centre.

(5)

 Persons entering the approved quarantine facility or centre must wear protective clothing including footwear.

(6)

 No contacts between personnel shall take place, which may cause contamination between approved quarantine facilities or units of approved quarantine centres.

(7)

 Appropriate equipment shall be available for cleaning and disinfection.

(8)

 If identification by microchipping is used, an appropriate microchip reader shall be available at the approved quarantine facility or centre.

(9)

 Cleaning and disinfection of the cages or crates used for the transport must be carried out at the approved quarantine facility or centre unless they are destroyed. If reused, they must be made of a material that allows effective cleaning and disinfection. The cages and crates must be destroyed in such a way so as to avoid spread of disease causing agents.

(10)

 Litter and waste material shall be collected regularly, stored in the litter container and subsequently treated in such a way as to avoid spread of disease-causing agents.

(11)

 Carcases of birds must be examined in an official laboratory designated by the competent authority.

(12)

 The necessary analyses and treatments of birds must be carried out in consultation with and under the control of the official veterinarian.

(13)

 The official veterinarian must be informed of diseases and death of birds and/or sentinel birds during the quarantine.

(14)

 The person in charge of the approved quarantine facility or centre must keep a record of:

(a)

the date, number and species of birds entering and leaving for each consignment;

(b)

copies of the animal health certificates and the Common Veterinary Entry Documents accompanying the imported birds;

(c)

individual identification numbers of the imported birds, and in case of identification by microchip the details of the type of microchip and the reader used shall be recorded;

(d)

if in the quarantine facility or centre sentinel birds are used, the number and placing of the sentinel birds in the quarantine facility or centre;

(e)

any significant observation: cases of illness and number of deaths on a daily basis;

(f)

dates and results of testing;

(g)

types and dates of treatment;

(h)

persons entering and leaving the quarantine facility or centre.

(15)

 The records referred to in point 14 shall to be kept for at least 10 years.

CHAPTER 3

Suspending, withdrawing or regranting approval of quarantine facilities and centres

The procedures for partly or completely suspending, withdrawing or regranting approval of quarantine facilities and centres shall comply with the conditions set out in this Chapter.

(1)

Where the competent authority finds that a quarantine facility or centre no longer complies with the conditions set out in Chapters 1 and 2, or there has been a change of use which is no longer covered by Article 3(e) and (f), it shall inform the Commission of this fact. Such quarantine facilities or centres shall not be used for imports in accordance with this Regulation.

(2)

Approval shall only be regranted to a quarantine facility or centre when the conditions laid down in Chapters 1 and 2 are again fulfilled.

ANNEX V

Examination, sampling and testing procedures for avian influenza and Newcastle disease

(1)

 During quarantine either the sentinel birds, or if sentinel birds are not used, the imported birds, shall be subjected to the following procedures:

(a)

with use of sentinel birds:

(i)

blood samples for serological examination must be taken from all sentinel birds not less then 21 days following their entry into the quarantine and at least three days before the end of the quarantine;

(ii)

if sentinel birds show positive or inconclusive serological results for the samples referred to in point (i), the imported birds must be subjected to virological examination; cloacal swabs (or faeces) and tracheal/oropharyngeal swabs must be taken from at least 60 birds or from all birds if the consignment is less than 60 birds;

(b)

without use of sentinel birds, imported birds must be examined virologically (serological testing not being appropriate). Tracheal/oropharyngeal and/or cloacal swabs (or faeces) must be taken from at least 60 birds or from all birds if the consignment is less than 60 birds, during the first 7 to 15 days of the quarantine.

(2)

 In addition to the testing set out in point 1, the following samples shall be taken for virological examination:

(a)

cloacal swabs (or faeces) and tracheal/oropharyngeal swabs, if possible, from clinically ill birds or ill sentinel birds;

(b)

from the intestinal contents, brain, trachea, lungs, liver, spleen, kidneys and other obviously affected organs as soon as possible following the death from either:

(i)

dead sentinel birds and all birds dead on arrival and those which die during quarantine; or

(ii)

in the case of high mortality in small birds of large consignments from at least 10 % of the dead birds.

(3)

 All virological and serological testing of samples taken during quarantine must be carried out in official laboratories designated by the competent authority using diagnostic procedures in accordance with the diagnostic manual for avian influenza and the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the OIE for Newcastle disease. For virological examination pooling of samples up to a maximum of five samples of individual birds in one pool is allowed. Faecal material must be pooled separately from other organ and tissue samples.

(4)

 Virus isolates must be submitted to the national reference laboratory.

ANNEX VI

Repealed Regulation with list of its successive amendments

Commission Regulation (EC) No 318/2007

(OJ L 84, 24.3.2007, p. 7).

Commission Regulation (EC) No 1278/2007

(OJ L 284, 30.10.2007, p. 20).

Commission Regulation (EC) No 86/2008

(OJ L 27, 31.1.2008, p. 8).

Commission Regulation (EC) No 311/2008

(OJ L 93, 4.4.2008, p. 3).

Commission Regulation (EC) No 607/2008

(OJ L 166, 27.6.2008, p. 18).

Commission Regulation (EC) No 754/2008

(OJ L 205, 1.8.2008, p. 6).

Commission Regulation (EC) No 1219/2008

(OJ L 330, 9.12.2008, p. 4).

Commission Regulation (EC) No 1294/2008

(OJ L 340, 19.12.2008, p. 41).

Commission Regulation (EC) No 201/2009

(OJ L 71, 17.3.2009, p. 3).

Commission Regulation (EC) No 555/2009

(OJ L 164, 26.6.2009, p. 37).

Commission Regulation (EC) No 1118/2009

(OJ L 307, 21.11.2009, p. 3).

Commission Regulation (EU) No 239/2010

(OJ L 75, 23.3.2010, p. 18).

Commission Implementing Regulation (EU) No 66/2012

(OJ L 23, 26.1.2012, p. 1).

Commission Implementing Regulation (EU) No 390/2012

(OJ L 121, 8.5.2012, p. 18).

ANNEX VII

Correlation Table

Regulation (EC) No 318/2007

This Regulation

Articles 1 and 2

Articles 1 and 2

Article 3, first paragraph

Article 3, first paragraph

Article 3, second paragraph, points (a) to (h)

Article 3, second paragraph, points (a) to (h)

Article 3, second paragraph, point (i)

—

Article 4

Article 4

Article 5, introductory wording

Article 5, introductory wording

Article 5, point (a)

Article 5, point (a)

Article 5, point (b)

Article 5, point (b)

Article 5, point (ba)

Article 5, point (c)

Article 5, point (c)

Article 5, point (d)

Article 5, point (d)

Article 5, point (e)

Article 5, point (e)

Article 5, point (f)

Article 5, point (f)

Article 5, point (g)

Article 5, point (g)

Article 5, point (h)

Article 5, point (h)

Article 5, point (i)

Article 5, point (i)

Article 5, point (j)

Articles 6 to 18

Articles 6 to 18

Article 19

—

—

Article 19

Article 20, first paragraph

Article 20

Article 20, second paragraph

—

Annexes I to IV

Annexes I to IV

Annex VI

Annex V

—

Annex VI

—

Annex VII
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