compliance by the confined establishment with the requirement to be approved by the competent authority of the third country or territory of origin laid down in Article 30;

the competent authority of the third country or territory of origin must have provided sufficient information to guarantee that the confined establishment complies with the requirements concerning the approval of confined establishments laid down in Article 30.

it must be clearly demarcated and the access of animals and humans to animal facilities must be controlled;

it must have adequate means for catching, confining and isolating animals, and have available and adequate quarantine facilities and approved standard operating procedures for new incoming animals;

the animal accommodation areas must be of a suitable standard and constructed in such a way that:

as regards disease surveillance and control measures:

it must keep, for a minimum period of 3 years, up-to-date records indicating:

it must ensure the disposal of the dead bodies of ungulates which die of a disease or are euthanised;

it must secure by contract or other legal instrument the services of an establishment veterinarian who shall be responsible for:

by way of derogation from Article 9(c), either has:

a prior application to the competent authority of the Member State of destination for a specific derogation as provided for in Article 31 was made by the owner, or a natural person representing that owner, and the Member State of destination granted that authorisation after having carried out a risk assessment that has indicated that the introduction of such a consignment of ungulates would not present an animal health risk for the Union;

the ungulates have been quarantined in the third country or territory of origin under the supervision of the competent authority for the necessary period of time required for them to comply with the specific animal health requirements laid down in Articles 33 and 34:

the ungulates must be quarantined in the confined establishment of destination for a period of at least 6 months from the date of entry into the Union, during which period the actions provided for in Article 138(2) of Regulation (EU) 2017/625 and in particular in its points 2(a), (d) and (k) may be taken by the competent authority of the Member State of destination.

as regards the confined establishment of origin of the ungulates, listed diseases referred to in the table set out in Part A of Annex XII have not been reported for the periods specified for those listed diseases in that table;

as regards the area in and around the confined establishment, listed diseases referred to in the table set out in Part B of Annex XII have been not reported for the periods specified for those listed diseases in that table.

they must comply with a residency period in the confined establishment of origin for a continuous period of 6 months or since birth if they are less than 6 months of age;

they must not have been in contact with animals of a lower health status during:

as regards the diseases referred to in the table set out in Part C of Annex XII, they must either:

they must not have been vaccinated as referred to in the table set out in Part E of Annex XII;

if they have been vaccinated against anthrax and rabies, information on the date of vaccination, the vaccine used and the possible test performed to show a protective immune response, must have been provided by the competent authority of the third country or territory of origin;

they must have been treated against internal and external parasites at least twice during the period of 40 days prior to date of dispatch to the Union.

queen honeybees;

bumble bees.

the packaging material and queen cages used to dispatch the honeybees and bumble bees into the Union must:

the feedingstuff accompanying the honeybees and bumble bees must be free from pathogens causing their diseases;

the packaging material and accompanying products must have undergone a visual examination prior to dispatch to the Union to ensure that they do not pose an animal health risk and do not contain:

of at least a 100 km radius, including where appropriate the territory of a neighbouring third country:

of at least 3 km radius, including where appropriate the territory of a neighbouring third country:

the honeybees of the consignment must originate from a third country or territory or zone thereof free from infestation with infestation with Varroa spp. (Varroosis);

in the third country or territory of origin or zone thereof, infestation with Varroa spp. (Varroosis) has not been reported for a period of 30 days prior to the date of loading for dispatch to the Union;

every precaution has been taken to avoid contamination of the consignment with Varroa spp. during loading and dispatch to the Union.

have been bred and kept in an environmentally isolated bumble bee production establishment which:

within the establishment referred to in point (a), the bumble bees must come from an epidemiological unit in which infestation with Aethina tumida (Small hive beetle) has not been detected.

supervise the transfer from the transport cage to the new cages referred to in Article 71(1);

ensure the submission by the operator of the materials referred to in Article 71(2);

ensure that the official laboratory referred to in Article 71(2) have arrangements in place to destroy the cages, attendants and the material after the laboratory examination provided for in that provision.

prior to the date of collection, remained in a third country or territory or zone thereof which is listed for the entry into the Union of the particular species and category of germinal product:

for a period of at least 30 days prior to the date of first collection of the germinal products and during the collection period:

they are marked in such a way that the following information can be readily established:

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they fulfil animal health requirements for the collection, production, processing and storage set out in Annex III to Delegated Regulation (EU) 2020/686.

that semen was collected and dispatched from a single semen collection centre where it was collected;

there were procedures in place as regards processing of that semen in order to ensure that it complies with the marking requirements of point (a) of Article 83.

a visual examination of the transport container in order to verify compliance with the requirements laid down in Article 84;

a documentary check of the data submitted by the centre or team veterinarian to ensure that:

comply with the requirements of Article 23;

in the case of donor animals of semen prior to their admission to a quarantine accommodation, were free from the following diseases:

comply with the specific animal health requirements laid down in Part 2 and Chapters I, II, III and IV of Part 5 of Annex II to Delegated Regulation (EU) 2020/686;

were not vaccinated against infection with porcine reproductive and respiratory syndrome virus.

an assessment was carried out by the competent authority of the Member State of destination of the risks associated with the entry into the Union of those germinal products;

the donor animals of those germinal products originate from a confined establishment in the third country or territory of origin or zone thereof, which is included in a list established in accordance with Article 29 of confined establishments from which the entry of ungulates into the Union may be authorised;

the germinal products are destined to a confined establishment in the Union, which is approved in accordance with Article 95 of Regulation (EU) 2016/429;

the germinal products are transported directly to the confined establishment referred to in point (c).

the donor animals did not come from an establishment, nor been in contact with animals from an establishment, situated in a restricted zone established due to the occurrence of a category A disease or of an emerging disease relevant for the bovine, porcine, ovine, caprine or equine animals;

the donor animals come from an establishment where none of the category D diseases relevant for bovine, porcine, ovine, caprine or equine animals have been reported for a period of at least 30 days prior to the date of collection of the semen, oocytes or embryos;

the donor animals remained in a single confined establishment of origin for a period of at least 30 days prior to the date of collection of semen, oocytes or embryos intended for entry into the Union and during the period of that collection;

the donor animals were clinically examined by the establishment veterinarian responsible for the activities carried out at confined establishment, and showed no disease symptoms on the day the semen, oocytes or embryos were collected;

as much as possible, the donor animals were not used for natural breeding during a period of at least 30 days prior to the date of first collection of semen, oocytes or embryos intended for entry into the Union and during the period of that collection;

the donor animals are identified in accordance with Article 21.

marked in accordance with the information requirements provided for in point (a) of Article 83;

transported in accordance with Articles 84 and 85.

remained in the third country or territory of origin or zone thereof;

remained in the establishment of origin, and no animals have been introduced into that establishment during that period of time prior to loading;

had no contact with poultry or hatching eggs of a lower health status, or with captive birds or wild birds.

the hatching eggs intended for entry into the Union must not have come into contact with poultry, captive birds or hatching eggs not intended for entry into the Union or of a lower health status from the time of loading at the establishment of origin for dispatch to the Union until the time of arrival in the Union;

the hatching eggs must not have been transported, unloaded in, or moved to another means of transport when transported by road, by sea or by air through a third country or territory or zone thereof which is not listed for entry of the particular species and category of hatching eggs into the Union.

the entry into the Union of the hatching eggs is authorised by the competent authority of the Member State of destination and, where applicable, the Member States of passage until their arrival at their place of destination in the Union;

the transhipment was supervised by an official veterinarian or the responsible customs officer and throughout the operation:

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the hatching eggs are accompanied by a declaration from the competent authority of the third country or territory where the transfer took place, providing the necessary information on the transfer operation and attesting that the relevant measures were put in place to comply with the requirements laid down in point (b).

the hatching eggs must have been transported in means of transport which:

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the hatching eggs must have been transported in containers which comply with the following requirements:

transported directly from the point of entry to their place of destination in the Union;

comply with the requirements for movement within the Union and handling following their entry into the Union as laid down for the particular species and category of hatching eggs in Chapters 5 and 7 of this Title.

the flocks of origin of the hatching eggs were imported from a third country or territory or zone thereof, which is listed for entry into Union of such flocks;

the import of the flocks of origin of the hatching eggs into that third country or territory or zone thereof took place in accordance with animal health requirements that are at least as stringent as if they were directly entered into the Union.

it has a disease surveillance programme for highly pathogenic avian influenza in place for a period of at least 6 months prior to the date of dispatch of the consignment to the Union and that surveillance programme complies with the requirements laid down in either:

which is considered to be free from highly pathogenic avian influenza in accordance with Article 38;

if it carries out vaccination against highly pathogenic avian influenza, the competent authority of the third country or territory of origin has provided guarantees that:

which:

if vaccination against infection with Newcastle disease virus is carried out, the competent authority of the third country or territory has provided guarantees that:

it has undertaken that following any outbreak of highly pathogenic avian influenza or an outbreak of infection with Newcastle disease virus, to submit the following information to the Commission:

which has undertaken to submit virus isolates from initial outbreaks of highly pathogenic avian influenza or infection with Newcastle disease virus to the European Union Reference Laboratory for Avian Influenza and Newcastle disease.

hatcheries approved by the competent authority of the third country or territory of origin in accordance with requirements which are at least as stringent as those laid down in Article 7 of Delegated Regulation (EU) 2019/2035; and

flocks which have been kept in establishments approved by the competent authority of the third country or territory of origin in accordance with requirements which are at least equivalent to those laid down in Article 8 of Delegated Regulation (EU) 2019/2035 and

where they have been vaccinated against highly pathogenic avian influenza, guarantees for compliance with the minimum requirements for vaccination programmes and additional surveillance set out in Annex XIII, have been provided by the third country or territory of origin;

where they have been vaccinated against infection with Newcastle disease virus:

they have undergone a disease surveillance programme that meets the requirement set out Annex II of Delegated Regulation (EU) 2019/2035 and were found not to be infected or showed any grounds for suspecting any infection by the following agents:

they were kept in establishments which, in case of confirmation of infection with Salmonella Pullorum, S. Gallinarum and S. arizonae during the last 12 months prior to date of collection of the eggs for dispatch to the Union have applied the following measures:

they were kept in establishments which in case of confirmation of avian mycoplasmosis (Mycoplasma gallisepticum and M. meleagridis) during the last 12 months prior to date of collection of the eggs for dispatch to the Union have applied the following measures:

either

they have either:

if the hatching eggs have been vaccinated against highly pathogenic avian influenza, guarantees for compliance with the minimum requirements for vaccination programmes and additional surveillance set out in Annex XIII, have been provided by the third country or territory of origin;

if the hatching eggs have been vaccinated against infection with Newcastle disease virus:

the hatching eggs must be marked:

the hatching eggs must have been disinfected in accordance with the instructions of the competent authority of the third country or territory of origin.

are not vaccinated against infection with Newcastle disease virus;

originate from flocks which comply with the requirements set out in one of the following points:

they come from establishments:

in relation to vaccination against highly pathogenic avian influenza:

in relation to vaccination against Newcastle disease virus, the hatching eggs have not been vaccinated against Newcastle disease virus and where the flock of origin has been vaccinated against infection with Newcastle disease virus:

they come from flocks which have been subjected to a clinical inspection, carried out by an official veterinarian in the third country or territory of origin or zone thereof, within a period of 24 hours prior to the time of loading of the consignments of hatching eggs for dispatch to the Union for the purpose of the detection of signs indicative of the occurrence of diseases, including the relevant listed diseases referred to in Annex I and emerging diseases, and the flocks showed no disease symptoms or grounds for suspecting the presence of any of those diseases;

they come from flocks which:

the hatching eggs must have been disinfected in accordance with the instructions of the competent authority of the third country or territory of origin.

they originate from flocks which:

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they have been marked using colour ink with a stamp bearing the ISO code of the third country or territory of origin and the unique approval number of the establishment of origin;

they have been disinfected in accordance with the instructions of the competent authority of the third country or territory of origin.

they undergo a virus detection test for infection with Newcastle disease virus carried out by the competent authority on a cloacal swab or faeces sample from each ratite;

in the case of ratites destined for a Member State with status free from infection with Newcastle disease virus without vaccination, in addition to the requirements referred to in point (a), they are subjected to a serological test for infection with Newcastle disease virus carried out by the competent authority on each ratite;

all ratites shall have tested negative to the tests provided for in points (a) and (b) prior to their release from isolation.

place the hatching eggs of captive birds which have entered into the Union from a third country or territory or zone thereof in separate incubators, including hatchers, from other hatching eggs;

ensure that captive birds which are hatched from the hatching eggs of captive birds referred to in Article 115 are kept in an approved quarantine establishment in accordance with the requirements of Articles 59 to 61.

the establishment of origin of the animals is located, either:

the kept animals were dispatched directly from their establishment of origin to the slaughterhouse;

during the transport to the slaughterhouse referred to in point (a), the kept animals:

the means of transport and containers used to transport the kept animals to the slaughterhouse referred to in point (a) comply with the requirements laid down in Articles 17 and 18;

By way of derogation of point (c)(i), during their transport to the slaughterhouse, consignments of poultry may pass through a zone of a third country or territory not listed for entry into the Union of fresh meat of poultry other than ratites, subject to the following conditions:

If no suitable alternatives are possible and provided that all the conditions listed in (i) to (vi) of this point are complied with, poultry transported to the slaughterhouse may pass through more than one zone referred to in this point.

the carcasses were dispatched directly from the place of killing to a game handling establishment situated in the same listed third country or territory or zone;

during the transport to the game handling establishment referred to in point (a), the carcasses:

the carcasses were transported to the game handling establishment referred to in point (a) in means of transport and containers which comply with the following requirements:

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in the case of kept animals:

in the case of wild animals, a post-mortem inspection carried out, without delay, after their killing.

it was packed for further storage or dispatch to the Union;

or

its arrival to the Union, in the case of unpacked fresh meat.

the raw milk or dairy product therefrom, from which they were processed, were obtained from animals of the species Bos taurus, Ovis aries, Capra hircus, Bubalus bubalis and Camelus dromedarius;

the raw milk or dairy product therefrom, used for the processing of the dairy products complied with the relevant general animal health requirements for the entry into the Union of products of animal origin laid down in Articles 3 to 10 and the specific animal health requirements for the entry into the Union of raw milk laid down in Articles 153 and 154, and therefore was eligible for entry into the Union and it originates from one of the following:

Annex II to this Regulation;

or

the relevant Chapter of the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE).

during the period of 30 days prior to the date of collection of the eggs and until the date of issue of the certificate for entry into the Union, no outbreak of highly pathogenic avian influenza or infection with Newcastle disease virus occurred; and

within a 10 km radius of the establishment, including, where appropriate, the territory of a neighbouring country there was no outbreak of highly pathogenic avian influenza or infection with Newcastle disease virus for a period of at least 30 days prior to the date of collection of eggs and until the date of issue of the certificate for entry into the Union.

Annex II to this Regulation;

or

the relevant Chapter of the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE).

in which, during the period of 30 days prior to the date of collection of the eggs, no outbreak of highly pathogenic avian influenza and infection with Newcastle disease virus has occurred;

within a 10 km radius of the establishment, including, where appropriate, the territory of a neighbouring country, there has either been:

within a 10 km radius of the establishments, including, where appropriate, the territory of a neighbouring country, there has either been: