02020R0692 — EN — 25.09.2021 — 001.001

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►B COMMISSION DELEGATED REGULATION (EU) 2020/692 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin (Text with EEA relevance) (OJ L 174 3.6.2020, p. 379)

Amended by:









▼B

COMMISSION DELEGATED REGULATION (EU) 2020/692

of 30 January 2020

supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin

(Text with EEA relevance)







PART I

GENERAL RULES







TITLE 1

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter and scope

1. This Regulation lays down supplementing animal health rules concerning the entry into the Union of consignments of certain species and categories of animals, germinal products and products of animal origin from third countries or territories or zones thereof, or compartments in the case of aquaculture animals. It also lays down rules concerning the movement and handling of those consignments after their entry in the Union.

2. Part I lays down: (a) the obligations on the competent authority of Member States to permit the entry into the Union of consignments of animals, germinal products and products of animal origin of species and categories of animals covered by Parts II to VI (Articles 3 and 4); (b) the obligations on the operators regarding the entry into the Union, and the movement and handling after entry, of consignments of animals, germinal products and products of animal origin covered by Parts II to VI (Article 5); (c) the general animal health requirements for entry into the Union, and the movement and handling after the entry of the consignments referred to in points (a) and (b), and derogations from those general requirements, applicable to all the species and categories of animals, germinal products and products of animal origin covered by Parts II to VI (Articles 6 to 10).

3. Part II lays down the general animal health requirements for entry into the Union, as well as the movement and handling after the entry, and derogations from such requirements for certain terrestrial animals (Title 1).

In addition, it lays down specific animal health requirements that are also applicable to the each of those species and categories of terrestrial animals, in particular:

(a) kept ungulates of listed species (Title 2);

(b) poultry and captive birds, except captive birds imported for conservation programmes approved by the competent authority of the Member State of destination (Title 3);

(c) honeybees (Apis mellifera) and bumble bees (Bombus spp.) (Title 4);

(d) dogs, cats and ferrets (Title 5).

4. Part III lays down the general animal health requirements for entry into the Union, as well as the movement and handling after the entry, and derogations from such requirements for germinal products of the following species and categories of kept terrestrial animals: (a) bovine, porcine, ovine, caprine and equine animals (Title 1); (b) poultry and captive birds (Title 2); (c) animals other than those listed in points (a) and (b) (Title 3).

5. Part IV lays down the general animal health requirements for entry into the Union, as well as the movement and handling after the entry, and derogations from those requirements for products of animal origin of the following species and categories of terrestrial animals: (a) kept and wild ungulates of listed species; (b) poultry; (c) game birds.

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6. Part V lays down the animal health requirements for the entry into the Union, as well as the movement and handling after the entry, and derogations from those requirements for the following species of aquatic animals at all life stages as well as their products of animal origin, excluding products of animal origin other than live aquatic animals which are intended for direct human consumption and wild aquatic animals and products of animal origin from those wild aquatic animals landed from fishing vessels intended for direct human consumption: ▼B (a) fish of listed species belonging to the superclass Agnatha and to the classes Chondrichthyes, Sarcopterygii and Actinopterygii; (b) aquatic molluscs of listed species belonging to the phylum Mollusca; (c) aquatic crustaceans of listed species belonging to the subphylum Crustacea; (d) aquatic animals of species listed in Annex XXIX which are susceptible to the aquatic diseases for which certain Member States have national measures to limit the impact of diseases other than listed diseases, as provided for in Article 226 of Regulation (EU) 2016/429.

7. Part VI lays down the general rules, certain derogations and additional requirements for transit through the Union and for the return to the Union of certain species and categories of animals, germinal products and products of animal origin.

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8. Part VII lays down transitional and final provisions.

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Article 2

Definitions

For the purposes of this Regulation, the definitions laid down in Implementing Regulation (EU) 2018/1882 and Annex I to Regulation (EC) No 853/2004 shall apply, except where those definitions cover terms that are defined in the second paragraph of this Article.

In addition, the following definitions shall also apply:

(1) ‘listed third country, territory or zone thereof’ means a third country, territory or zone thereof included in a list of third countries, territories or zones thereof, or compartments in the case of aquaculture animals, from which the entry into the Union of a particular species and category of animals, germinal products and products of animal origin is permitted in accordance with implementing acts adopted pursuant to Article 230(1) of Regulation (EU) 2016/429;

(2) ‘the list’ means the list of third countries, territories or zones thereof, or compartments in the case of aquaculture animals, authorised for entry into the Union of consignments of a particular species and category of animals, germinal products or products of animal origin by implementing acts adopted pursuant to Article 230(1) of Regulation (EU) 2016/429;

(3) ‘means of transport’ means road or rail vehicle, vessels and aircrafts;

(4) ‘container’ means any crate, box, receptacle or other rigid structure used for the transport of animals, germinal products or products of animal origin which is not the means of transport;

(5) ‘bovine animal’ means an animal of the species of ungulates belonging to the genera Bison, Bos (including the subgenera Bos, Bibos, Novibos, Poephagus) and Bubalus (including the subgenus Anoa) and the offspring of crossings of those species;

(6) ‘ovine animal’ means an animal of the species of ungulates belonging to the genus Ovis and the offspring of crossings of those species;

(7) ‘caprine animal’ means an animal of the species of ungulates belonging to the genus Capra and the offspring of crossings of those species;

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(8) ‘porcine animal’ means an animal of the species of ungulates belonging to the family Suidae listed in Annex III to Regulation (EU) 2016/429 for the purpose of entry into the Union of an animal or an animal of the species Sus scrofa, for the purpose of entry into the Union of germinal products;

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(9) ‘equine animal’ means an animal of species of solipeds belonging to the genus Equus (including horses, asses, and zebras) and the offspring of crossings of those species;

(10) ‘camelid animal’ means an animal of the species of ungulates belonging to the family Camelidae listed in Annex III to Regulation (EU) 2016/429;

(11) ‘cervid animal’ means an animal of the species of ungulates belonging to the family Cervidae listed in Annex III to Regulation (EU) 2016/429;

(12) ‘registered equine animal’ means: (a) a purebred breeding animal of the species Equus caballus and Equus asinus entered or eligible for entry in the main section of a breeding book established by a breed society or breeding body recognised in accordance with Article 4 or 34 of Regulation (EU) 2016/1012; (b) a kept animal of the species Equus caballus registered with an international association or organisation, either directly or through its national federation or branches, which manages horses for competition or racing (‘registered horse’);

(13) ‘animals intended for slaughter’ means kept terrestrial animals to be transported, either directly or after undergoing an assembly operation, to a slaughterhouse;

(14) ‘disease has not been reported’ means that no animal or group of animals of relevant species kept on the establishment has been classified as a confirmed case of that disease and any suspect case of that disease has been ruled out;

(15) ‘sanitary group’ means a group of listed third countries in which common animal health risks as regards diseases listed for equine animals prevail that require specific risk-mitigating measures and health guarantees when equine animals enter into the Union;

(16) ‘flock’ means all poultry or captive birds of the same health status kept on the same premises or in the same enclosure and constituting a single epidemiological unit; in housed poultry, this includes all birds sharing the same airspace.

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

(18) ‘productive poultry’ means poultry 72 hours old or more, reared for the production of meat, eggs for consumption or other products or for restocking supplies of game birds;

(19) ‘day-old chicks’ means poultry less than 72 hours old;

(20) ‘honeybee’ means an animal of the Apis mellifera species;

(21) ‘bumble bee’ means an animal of the species belonging to the genus Bombus;

(22) ‘dog’ means a kept animal of the Canis lupus species;

(23) ‘cat’ means a kept animal of the Felis silvestris species;

(24) ‘ferret’ means a kept animal of the Mustela putorius furo species;

(25) ‘unique approval number’ means a number assigned by the competent authority;

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

(27) ‘consignment of semen, oocytes or embryos’ or ‘consignment of germinal products’ means a quantity of semen, oocytes, in vivo derived embryos or in vitro produced embryos dispatched from a single approved germinal product establishment covered by a single animal health certificate;

(28) ‘semen’ means the ejaculate of an animal or animals, either in the unaltered state or prepared or diluted;

(29) ‘oocytes’ means the haploid stages of the ootidogenesis including secondary oocytes and ova;

(30) ‘embryo’ means the initial stage of development of an animal while it is capable of being transferred to a recipient dam;

(31) ‘approved germinal product establishment’ means a semen collection centre, an embryo collection team, an embryo production team, a germinal product processing establishment or a germinal product storage centre;

(32) ‘centre veterinarian’ means the veterinarian responsible for the activities carried out at the semen collection centre, at the germinal product processing establishment or at the germinal product storage centre as provided for in this Regulation;

(33) ‘team veterinarian’ means the veterinarian responsible for the activities carried out by an embryo collection team or by an embryo production team as provided for in this Regulation;

(34) ‘quarantine accommodation’ means a facility authorised by the competent authority for the purpose of the isolation of bovine, porcine, ovine or caprine animals for a period of at least 28 days before they are admitted to a semen collection centre;

(35) ‘semen collection centre’ means a germinal product establishment approved by the competent authority for the collection, processing, storage and transport of semen of bovine, porcine, ovine, caprine or equine animals intended for entry into the Union;

(36) ‘embryo collection team’ means a germinal product establishment comprised of a group of professionals or structure approved by the competent authority for the collection, processing, storage and transport of in vivo derived embryos intended for entry into the Union;

(37) ‘embryo production team’ means a germinal product establishment comprised of a group of professionals or structure approved by the competent authority for the collection, processing, storage and transport of oocytes, and the in vitro production, where applicable with stored semen, processing, storage and transport of embryos, both intended for entry into the Union;

(38) ‘germinal product processing establishment’ means a germinal product establishment approved by the competent authority for the processing, including semen sex-sorting where appropriate, and the storage of semen, oocytes or embryos of one or more species, or any combination of those types of germinal products or species, intended for entry into the Union;

(39) ‘germinal product storage centre’ means a germinal product establishment approved by the competent authority for the storage of semen, oocytes or embryos of one or more species, or any combination of those types of germinal products or species, intended for entry into the Union;

(40) ‘meat’ means all parts of ungulates, poultry and game birds which are suitable for human consumption, including blood;

(41) ‘fresh meat’ means meat, minced meat and meat preparations, including vacuum-wrapped or wrapped in a controlled atmosphere, which has not undergone any preserving process other than chilling, freezing or quick-freezing;

(42) ‘carcase of an ungulate’ means the whole body of a slaughtered or killed ungulate after: (a) bleeding, in the case of slaughtered animals; (b) evisceration; (c) removal of the limbs at the carpus and tarsus; (d) removal of the tail, the udder, the head and the skin, except in porcine animals.

(43) ‘offal’ means fresh meat other than that of a carcase of an ungulate even if it remains naturally connected to the carcase;

(44) ‘meat products’ means processed products, including treated stomachs, bladders, intestines, rendered animal fats and meat extracts, resulting from the processing of meat or from the further processing of such processed products, so that the cut surface shows that the product no longer has the characteristics of fresh meat;

(45) ‘casings’ means the bladders and intestines that after cleaning have been processed by tissue scraping, defatting and washing and have been treated with salt or dried;

(46) ‘colostrum’ means the fluid secreted by the mammary glands of kept animals up to 3 to 5 days post-parturition that is rich in antibodies and minerals, and precedes the production of raw milk;

(47) ‘colostrum-based products’ means processed products resulting from the processing of colostrum or from the further processing of such processed products;

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(48) ‘well-boat’ means a ‘well-boat’ as defined in Article 2, point 2, of Commission Delegated Regulation (EU) 2020/990 ( 1 );

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(49) ‘IMSOC’ means the information management system for official controls provided for in Article 131 of Regulation (EU) 2017/625 ( 2 ).







TITLE 2

GENERAL ANIMAL HEALTH REQUIREMENTS FOR ENTRY INTO THE UNION, AND MOVEMENT AND HANDLING AFTER THE ENTRY OF CONSIGNMENTS OF ANIMALS, GERMINAL PRODUCTS AND PRODUCTS OF ANIMAL ORIGIN

Article 3

Obligations of the competent authorities of Member States

The competent authority shall permit the entry into the Union of consignments of animals, germinal products and products of animal origin of species and categories covered by Parts II to VI, which are presented for the purpose of official controls as provided for in Article 47(1) of Regulation (EU) 2017/625, provided that:

(a) the consignments come from: ▼M2 (i) in the case of terrestrial animals, germinal products and products of animal origin, a listed third country or territory or zone thereof for the particular species and category of animals, germinal products and products of animal origin; ▼B (ii) in the case of aquatic animals, a listed third country or territory or zone thereof for the particular species and category of animals and products of animal origin, and in the case of aquaculture animals, a listed third country or territory or zone or compartment thereof listed for that purpose;

(b) the competent authority of the third country or territory of origin has certified that the consignments comply with: (i) the general animal health requirements for entry into the Union of animals, germinal products and products of animal origin laid down in this Article, Article 4 and Articles 6 to 10; (ii) the animal health requirements applicable to the particular species and category of animals, germinal products and products of animal origin and intended use, as laid down in Parts II to VI;

(c) the consignments are accompanied by the following documents whereby the competent authority of the third country or territory of origin has provided the necessary guarantees as regards compliance with the animal health requirements referred to in point (b): (i) an animal health certificate issued by an official veterinarian of the third country or territory of origin, specific for the particular species and category of animals, germinal products and products of animal origin and their intended use; (ii) a declaration and other documents, where required in this Regulation. In the case of consignments of animals and hatching eggs, the animal health certificate, referred to in point (c)(i) must have been issued within the period of 10 days prior to the date of arrival of the consignment at the border control post; however, in the case of transport by sea that period may be extended by an additional period corresponding to the duration of the journey by sea.

Article 4

The date of certification of consignments

1. Consignments of animals, germinal products and products of animal origin of species and categories falling within the scope of this Regulation shall only be permitted to enter the Union provided that such consignments were certified for dispatch to the Union not earlier than the date on which the third country or territory of origin or zone thereof, or compartment thereof in the case of aquaculture animals, was listed for entry into the Union of the particular species and category of animals, germinal products and products of animal origin.

2. Consignments of animals, hatching eggs and products of animal origin originating from a third country or territory or zone thereof, or compartment thereof in the case of aquaculture animals, shall not be permitted to enter the Union from the date on which it no longer complies with the animal health requirements for entry into the Union of the particular species and category of animals, hatching eggs or products of animal origin, unless specific conditions have been assigned by the Union in the list to the listed third country, territory or zone thereof and to the particular species and categories of animals, hatching eggs or products of animal origin.

Article 5

Obligations of operators

1. Operators responsible for entry into the Union of consignments of animals, germinal products and products of animal origin of the species and categories falling within the scope of this Regulation, shall present those consignments to the competent authority in the Union for the purpose of official controls, as provided for in Article 47(1) of Regulation (EU) 2017/625, and shall ensure that such consignments comply with the following requirements: (a) the general animal health requirements for entry into the Union of the animals, germinal products and products of animal origin laid down in Articles 3 and 4 and Articles 6 to 10; (b) the animal health requirements applicable to the particular species and category of the animals, germinal products and products of animal origin of the consignment and its intended use, as laid down in Parts II to VI.

2. Operators responsible for the movement of consignments of animals, germinal products and products of animal origin of the species and categories falling within the scope of this Regulation from the point of entry in the Union to their place of destination, and those responsible for the handling of such consignments after their entry into the Union shall ensure that the consignments: (a) are permitted to enter the Union by the competent authority in accordance with Article 3; (b) comply with the animal health requirements for the movement and handling of such consignments after the entry into the Union for the specific species and categories of animals, germinal products and products of animal origin laid down in Parts II to VI; (c) are not diverted for uses other than those for which they were certified by the competent authority of the third country or territory of origin for entry into the Union.

Article 6

National legislation and animal health systems of the third country or territory of origin

1. Consignments of animals, germinal products and products of animal origin shall only be permitted to enter the Union from a third country or territory where: (a) any suspicion and confirmed case of a listed disease referred to in Annex I, relevant for the listed species of animals in the consignment or for the listed species of animals of origin of the germinal products or products of animal origin in the consignment authorised to enter the Union, are required by law to be notified and reported to the competent authority; (b) there are systems in place to detect emerging diseases; (c) there are systems in place to ensure that swill feeding is not a source of the listed diseases referred to in Annex I for: (i) the animals intended for entry into the Union; or (ii) the animals from which the germinal products intended for entry into the Union are obtained; or (iii) the animals from which the products of animal origin intended for entry into the Union are obtained.

2. Consignments of animals, germinal products and products of animal origin intended for entry into the Union shall only be permitted to enter the Union from a third country or territory or zone thereof where such consignments may be lawfully placed on the market and traded in that third country or territory of origin or zone thereof.

Article 7

General requirements as regards the health status of the animals, germinal products and products of animal origin

1. Consignments of animals shall only be permitted to enter the Union if the animals of the consignment: (a) are not animals to be killed under a national programme carried out in the third country or territory of origin for the eradication of diseases, including the relevant listed diseases referred to in Annex I and emerging diseases; (b) did not show symptoms of transmissible diseases at the time of loading for the dispatch to the Union; (c) originate from an establishment which, at the time of their dispatch from that establishment to the Union, was not subject to national restriction measures: (i) for animal health reasons; (ii) in the case of aquaculture animals, for animal health reasons or due to the occurrence of abnormal mortalities with an undetermined cause.

2. Consignments of germinal products shall only be permitted to enter the Union if they were obtained from animals which at the time of collection: (a) did not show symptoms of transmissible diseases; (b) were kept on an establishment which was not subject to national restriction measures for animal health reasons, including restrictions related to the relevant listed diseases referred to in Annex I and emerging diseases.

3. Consignments of products of animal origin shall only be permitted to enter the Union if they were obtained from animals which: (a) in the case of terrestrial animals, did not show symptoms of transmissible diseases at the time of: (i) killing or slaughter, for the production of fresh meat and meat products; or (ii) the collection of milk or eggs; (b) in the case of aquatic animals, did not show symptoms of transmissible diseases at the time of slaughter or collection for the production of products of animal origin. (c) were not killed, slaughtered or, in the case of molluscs and live crustaceans removed from the water, under a national programme for the eradication of diseases; (d) were kept on an establishment which was not subject to national restriction measures for animal health reasons, including where relevant, listed diseases referred to in Annex I and emerging diseases, at the time of: (i) the killing or slaughter of those animals for the production of fresh meat and meat products or products of animal origin from aquatic animals; or (ii) the collection of milk and eggs.

Article 8

General requirements as regards the establishment of origin of the animals

In addition to the specific requirements laid down in Parts II to V, consignments of animals, germinal products and products of animal origin shall only be permitted to enter the Union if the establishment of origin of the kept animals, or the establishment of origin of the kept animals from which the germinal products or products of animal origin were obtained, complies with the following requirements:

(a) it must be registered by the competent authority of the third country or territory of origin and assigned a unique registration number;

(b) it must be approved by the competent authority of the third country or territory of origin, where required by and under the conditions provided for in this Regulation, and assigned a unique approval number;

(c) it must be under the control of the competent authority of the third country or territory of origin;

(d) it must have a system in place to maintain and to keep, for a minimum period of 3 years, up-to-date records containing at least the following information: (i) the species, categories, number and where relevant, identification of animals on the establishment; (ii) movements of animals into and out of the establishment; (iii) mortality in the establishment.

(e) it must receive regular animal health visits from a veterinarian for the purpose of the detection of, and information on, signs indicative of the occurrence of diseases, including those listed diseases referred to in Annex I relevant for the particular species and category of animal, germinal product or product of animal origin and emerging diseases. Such animal health visits shall take place at frequencies that are proportionate to the risks posed by the establishment concerned.

Article 9

Sampling, laboratory tests and other tests

Consignments of animals, germinal products and products of animal origin shall only be permitted to enter the Union if sampling, laboratory tests and other tests required by this Regulation have been carried out:

(a) on samples taken by or under the control of the competent authority of: (i) the third country or territory of origin when sampling and testing are required prior to entry into the Union; or (ii) the Member State of destination when sampling and testing are required after the entry into the Union;

(b) in accordance with: (i) the relevant procedures and methods set out in Delegated Regulation (EU) 2020/689 and Delegated Regulation (EU) 2020/688 ( 3 ); or (ii) for the purpose of entry into the Union of germinal products of bovine, porcine, ovine, caprine and equine animals, the procedures and methods set out in Annex II to Commission Delegated Regulation (EU) 2020/686 ( 4 ); or (iii) the procedures described in this Regulation, where specifically required;

(c) in an official laboratory, designated in accordance with Article 37 of Regulation (EU) 2017/625.

Article 10

Disease freedom of the place of origin and specific conditions

1. Consignments of animals, germinal products and products of animal origin shall only be permitted to enter the Union if the freedom from particular diseases of the third country or territory of origin or zone thereof or of the establishment of origin of the animals, germinal products or products of animal origin, required by this Regulation has been demonstrated by the competent authority of the third country or territory of origin: (a) in accordance with Delegated Regulation (EU) 2020/689; or (b) for diseases not falling within the scope of Delegated Regulation (EU) 2020/689, in accordance with specific rules, where such rules are laid down in this Regulation, and the disease surveillance programme implemented by the third country or territory of origin, which must have been: (i) submitted to the Commission for assessment and contain at least the information referred to in Annex II; (ii) assessed by the Commission as providing the necessary guarantees as regards disease freedom based on: — the rules on disease surveillance laid down in Articles 24, 25, 26 and 27 of Regulation (EU) 2016/429, — the supplementing rules on surveillance design and the rules for disease confirmation and case definition laid down in Sections 1 and 2 and Article 10 of Chapter 1 of Part II of Delegated Regulation (EU) 2020/689; (iii) in place for a sufficient period of time for it to be fully implemented and properly supervised.

2. In the case of aquaculture animals and products of animal origin from aquaculture animals, where disease freedom from particular diseases is required for the compartment of origin, consignments of those commodities shall only be permitted to enter the Union if the competent authority of the third country of origin has demonstrated disease freedom in accordance with paragraph 1(a) and (b).

3. Where specific conditions related to the disease freedom from particular diseases of the third country or territory of origin, or zone thereof, are required in this Regulation: (a) the competent authority of the third country or territory of origin must have previously guaranteed its compliance; (b) those specific conditions shall have been specifically assigned by the Union in the list to the listed third country or territory, zone or compartment thereof and to the particular species and category of animals, germinal products and products of animal origin.







PART II

ANIMAL HEALTH REQUIREMENTS FOR ENTRY INTO THE UNION OF KEPT TERRESTRIAL ANIMALS AS REFERRED TO IN ARTICLES 3 AND 5







TITLE 1

GENERAL ANIMAL HEALTH REQUIREMENTS FOR KEPT TERRESTRIAL ANIMALS

Article 11

The residency period required for kept terrestrial animals

Consignments of kept terrestrial animals other than dogs, cats and ferrets, shall only be permitted to enter the Union subject to compliance with the following requirements:

(a) the animals complied with the relevant residency period set out in the following tables of Annex III for a continuous period of time immediately prior to the date of dispatch to the Union: (i) Table 1 in the case of ungulates, honeybees and bumble bees; (ii) Table 2 in the case of poultry and captive birds;

(b) the animals: (i) remained continuously in the third country or territory of origin or zone thereof during the period indicated in the second column of Table 1 in Annex III and the third column of Table 2 in Annex III; (ii) remained continuously in the establishment of origin, and no animals were introduced into that establishment during the period indicated in the third column of Table 1 in Annex III and the fourth column of Table 2 in Annex III; (iii) had no contact with animals of a lower health status during the period indicated in the fourth column of Table 1 in Annex III and the fifth column of Table 2 in Annex III.

Article 12

Derogations regarding the residency period for registered horses for competition, races and cultural events

1. By way of derogation of point (b)(i) of Article 11, equine animals other than equine animals intended for slaughter shall be regarded as complying with the residency period provided for in Table 1 of Annex III, if prior to their dispatch to the Union they have been resident during the period indicated in the second column of Table 1 of Annex III in addition to the third country or territory of origin or zone thereof also in: (a) a Member State; or (b) in case of registered horses, a listed third country or territory of intermediate residency, or zone thereof, from where the entry into the Union of registered horses is authorised for that purpose and provided that they were introduced into the third country or territory of origin, or zone thereof, in accordance with animal health requirements providing animal health guarantees at least as stringent as those applicable to the direct entry into the Union of registered horses for competition and races from that third country or territory of intermediate residence, or zone thereof.

2. By way of derogation from point (b)(ii) of Article 11, registered horses for competition, races and cultural equestrian events shall be regarded as complying with the residency requirements provided for in the third column of Table 1 of Annex III if they have been resident in the third country of origin or the third country of intermediate residence in establishments other than the establishment of origin provided that the other establishments: (a) have been under supervision of the official veterinarian in a third country or territory; (b) were not subject to national restriction measures for animal health reasons, including restrictions relating to the relevant diseases referred to in Annex I and relevant emerging diseases; (c) comply with the animal health requirements laid down in Article 23.

3. Also by way of derogation from point (b)(ii) of Article 11, registered horses for competition, races and cultural equestrian events that have had contact with equine animals which were entered into the third country, territory or zone thereof from another third country territory, or zone thereof, or from another zone in the third country or territory of origin shall be permitted to enter the Union provided that: (a) those equine animals were introduced into the third country or territory of origin or zone thereof in accordance with animal health requirements at least as stringent as those applicable to the direct entry into the Union of those equine animals; (b) the possibility of direct contact with other animals is limited to the period of the competition, races or cultural equestrian events and the related training, warm-up and pre-racing presentation.

Article 13

Inspection of terrestrial animals prior to dispatch to the Union

1. Consignments of terrestrial animals shall only be permitted to enter the Union if the animals of the consignment 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 the period of 24 hours prior to the time of loading 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.

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In the case of poultry, except day-old chicks, and captive birds, that inspection shall also cover the flock of origin of the animals intended for dispatch to the Union.

▼B

2. By way of derogation from the first subparagraph of paragraph 1, in the case of registered equine animals the inspection referred to therein may be carried out within 48 hours prior to the time of loading for dispatch to the Union or on the last working day prior to dispatch to the Union.

3. By way of derogation from the first subparagraph of paragraph 1, in the case of dogs, cats and ferrets the inspection referred to therein may be carried out within the period of 48 hours prior to the time of loading for dispatch to the Union.

Article 14

General rules for the dispatch to the Union of terrestrial animals

1. Consignments of terrestrial animals shall only be permitted to enter the Union if, from the time of loading at the establishment of origin for dispatch to the Union until the time of their arrival in the Union, the animals of the consignment have not been in contact with other terrestrial animals of: (a) the same species, not intended for entry into the Union; (b) other species listed for the same diseases, not intended for entry into the Union; (c) a lower health status.

2. When transported by air, sea, railway, road or on foot, the consignments referred to in paragraph 1 shall only be permitted to enter the Union if they have not been transported through, unloaded or transhipped in a third country or territory or zone thereof which is not listed for entry into the Union of the specific species and category of animals and their intended use in the Union.

3. When transported by sea, even for part of the journey, the consignments referred to in paragraph 1 shall only be permitted to enter the Union if they arrive to the Union accompanied by a declaration, attached to the animal health certificate accompanying the animals and signed by the master of the vessel, providing the following information: (a) the port of departure in the third country or territory of origin or zone thereof; (b) the port of arrival in the Union; (c) the ports of call, where the vessel called at ports outside the third country or territory of origin or zone thereof of the animals; (d) confirmation of compliance with the following requirements during the journey to the Union: (i) the animals have remained on board; (ii) the animals have not been into contact with animals of a lower health status while on board.

Article 15

Derogation for the transhipment of terrestrial animals other than equine animals in non-listed third countries or territories in the event of a technical problem or another unforeseen incident

1. By way of derogation from Article 14(2), the competent authority shall authorise the entry into the Union of consignments of terrestrial animals, other than equine animals, which have been transhipped from the original means of transport of dispatch into another means of transport for onward travel in a third country or territory or zone thereof which is not a listed third country or territory or zone thereof for entry of the particular species and category of animals into the Union, only if the transhipment operation took place because of the occurrence of a technical problem or another unforeseen incident causing logistic problems during the transport of the animals to the Union by sea or by air, in order to complete the transport to the point of entry into Union, provided that: (a) the entry into the Union of the consignment of animals is authorised by the competent authority of the Member State of destination and, where applicable, any Member States of passage until their arrival at their place of destination in the Union; (b) the transhipment was supervised by an official veterinarian in the third country or territory throughout the operation to ensure that: (i) effective protection measures against vectors of relevant animal diseases were put in place; (ii) effective measures were put in place to avoid direct and indirect contact between the animals intended for entry into the Union and any other animals; (iii) no feed, water or bedding, originating from a third country or territory or zone thereof which is not a listed third country or territory or zone thereof for entry of the particular species and category of animals into the Union, has been added in the means of transport for onward travel to the Union; (iv) the animals of the consignment were transferred directly and as quick as possible to a vessel or aircraft for onward travel to the Union, which complies with requirements laid down in Article 17, without leaving the boundaries of the port or airport; (c) the consignment of animals is accompanied by a declaration from the competent authority of the third country or territory where the transfer took place, providing information on the transfer operation and attesting that relevant measures were put in place to comply with the requirements laid down in point (b).

2. The derogation provided for in paragraph 1 shall not apply to consignments of honeybees and bumble bees.

Article 16

Derogation for the transhipment of equine animals in non-listed third countries or territories

By way of derogation from Article 14(2), where consignments of equine animals have been transhipped to another means of transport during the transport of the animals to the Union in a third country or territory or zone thereof which is not a listed third country or territory or zone thereof for entry of the particular category of equine animals, those consignments shall only be permitted to enter the Union if they comply with the following requirements:

(a) the animals of the consignment were transported to the Union by sea or by air;

(b) the animals of the consignment were transhipped directly from the original means of transport of dispatch into the other means of transport for onward travel;

(c) during the transhipment operation: (i) effective protection against vectors of relevant animal diseases was provided and the equine animals did not come into contact with equine animals of a lower health status; (ii) the animals of the consignment were transferred directly and as quickly as possible to the vessel or aircraft to be used for onward travel, which must have complied with the requirements laid down in Article 17, without leaving the boundaries of the port or airport under the direct supervision of an official veterinarian;

(d) an official veterinarian must have certified that the consignment complied with the requirements laid down in point (a), (b) and (c).

Article 17

General requirements regarding means of transport of terrestrial animals

1. Consignments of kept terrestrial animals shall only be permitted to enter the Union if the means of transport used for their transport are: (a) constructed in such a way that: (i) the animals cannot escape or fall out; (ii) visual inspection of the space where animals are kept is possible; (iii) the escape of animal excrements, litter or feed is prevented or minimised; (iv) in the case of poultry and captive birds, the escape of feathers is prevented or minimised; (b) cleaned and disinfected, with a disinfectant authorised by the competent authority of the third country or territory of dispatch, and dried or allowed to dry immediately before every loading of animals intended for entry into the Union.

2. Paragraph 1 shall not apply to the transport of consignments of honeybees and bumble bees intended for entry into the Union.

Article 18

Requirements regarding containers in which terrestrial animals are transported to the Union

Consignments of kept terrestrial animals shall only be permitted to enter the Union if the containers in which kept terrestrial animals are transported to the Union in the means of transport:

(a) comply with the requirements in Article 17(1)(a);

(b) contain only animals of the same species and category coming from the same establishment;

(c) are either: (i) unused and purpose-designed disposable containers to be destroyed after first use; or (ii) cleaned and disinfected and dried or allowed to dry before loading of animals intended for entry into the Union.

Article 19

Movement and handling after entry of terrestrial animals

1. Following their entry into the Union, consignments of terrestrial animals shall be transported directly without delay to: (a) their establishment of destination in the Union, where they shall remain at least for the period of time required in the relevant specific articles in Parts II to V; (b) the slaughterhouse of destination in the Union, if they are intended for slaughter, where they must be slaughtered within a period of 5 days from the date of their arrival in the Union.

2. Where the destination of the consignments of terrestrial animals entered from a third country or territory or zone thereof is a slaughterhouse, an approved quarantine establishment or a confined establishment in the Union, the transport to and arrival at the place of the destination of the consignment shall be monitored in accordance with Article 2 and 3 of Commission Delegated Regulation (EU) 2019/1666 ( 5 ).

3. Paragraphs 1 and 2 shall not apply to the entry into the Union of registered equine animals from third countries and to the re-entry after temporary export of registered horses.







TITLE 2

ANIMAL HEALTH REQUIREMENTS FOR UNGULATES







CHAPTER 1

Specific animal health requirements for ungulates

Article 20

Dispatch of ungulates to the Union

1. Consignments of ungulates shall only be permitted to enter the Union if such consignments have been dispatched from the establishment of origin to the Union without passing through any other establishment.

2. By way of derogation of paragraph 1, consignments of ungulates coming from more than one establishment of origin may be permitted to enter the Union if the animals of the consignment have undergone a single assembly operation in the third country or territory of origin or zone thereof subject to compliance with the following conditions: (a) the ungulates belong to one of the following species and categories: (i) Bos taurus, Ovis aries, Capra hircus or Sus scrofa; or (ii) Equidae intended for slaughter; (b) the assembly operation took place in an establishment: (i) approved for conducting assembly operations of ungulates by the competent authority in the third country or territory in accordance with requirements which are at least as stringent as to those laid down with Article 5 of Commission Delegated Regulation (EU) 2019/2035 ( 6 ); (ii) listed for that purpose by the competent authority of the third country or territory of dispatch, including the information provided for in Article 21 of Delegated Regulation (EU) 2019/2035; (iii) where the following records are maintained up-to-date and kept for a period of at least 3 years: — the origin of the animals, — the dates of arrival and dispatch to and from the assembly centre, — the identification code of the animals, — the registration number of the establishment of origin of the animals, — the registration number of the transporters and the means of transport delivering or collecting the consignment of ungulates to and from that centre; (iv) which complies with the requirements provided for in Article 8 and Article 23(1); (c) the assembly operation in the assembly centre took no longer than 6 days; this period shall be considered as part of the timeframe for sampling for testing prior to dispatch to the Union, where such sampling is required by this Regulation; (d) the ungulates must have arrived in the Union within a period of 10 days from the date of dispatch from the establishment of origin.

Article 21

Identification of ungulates

1. Consignments of ungulates, other than equine animals, shall only be permitted to enter the Union if the animals of the consignment were individually identified prior to being dispatched from the establishment of origin, by a physical means of identification with a visible, legible and indelible display of: (a) the identification code of the animal which establishes an unequivocal link between the animal and the accompanying animal health certificate; (b) the code of the exporting country in accordance with ISO Standard 3166 in the format of two-letter code.

2. Consignments of equine animals shall only be permitted to enter the Union if the animals of the consignment were individually identified prior to being dispatched from the establishment of origin at least by one of the following methods: (a) an injectable transponder or ear tag, with a visible, legible and indelible display of: (i) the identification code of the animal which establishes an unequivocal link between the animal and the accompanying animal health certificate; (ii) the ISO-3166 two-digit alpha or three-digit numeric country code of the exporting country; (b) in the case of equine animals other than those intended for slaughter, an identification document, issued at the latest at the time of certification for entry into the Union, which: (i) describes and depicts the animal, including the alternative methods of identification, so as to establish an unequivocal link between the animal and the accompanying identification document; (ii) contains information on the individual code emitted by an implanted injectable transponder in the case where this code does not comply with the specifications in point (a).

3. By way of derogation from paragraph 1, consignments of ungulates intended for confined establishments may be permitted to enter the Union if those animals are individually identified by an injectable transponder or an alternative method of identification which ensures an unequivocal link between the animal and its accompanying entry documentation.

4. Where ungulates are identified with an electronic identifier which does not comply with ISO Standards 11784 and 11785 the operator responsible for entry into the Union of the consignments of ungulates shall provide the reading device which enables at any time the verification of the identification of the animal.

Article 22

The third country or territory of origin of ungulates or zone thereof

1. Consignments of ungulates, other than equine animals, shall only be permitted to enter the Union if the animals of the consignment originate from a third country or territory or zone thereof free from the category A diseases referred to in the table set out in point 1 of Part A of Annex IV for the period referred to in that table.

2. Consignments of equine animals shall only be permitted to enter the Union if the animals of the consignment originate from a third country or territory or zone thereof: (a) free from the listed diseases referred in the table set out in point 2 of Part A of Annex IV for the period referred to in that table; (b) where none of the listed diseases referred to in the table set out in point 3 of Part A of Annex IV has been reported during the referred period.

3. The periods referred to in paragraph 1 and 2 may be reduced for diseases included in Part B of Annex IV under the relevant specific conditions referred therein.

4. Consignments of ungulates shall only be permitted to enter the Union if the animals of the consignment originate from a third country or territory or zone thereof where vaccination against the category A diseases referred to in Part C of Annex IV has not been carried out in accordance with the details set out in: (a) point 1 of that Annex in the case of ungulates, other than equine animals; (b) point 2 of that Annex in the case of equine animals.

5. As regards infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae, M. tuberculosis), consignments of bovine animals shall only be permitted to enter the Union if the animals of the consignment either: (a) originate from a third country or territory or zone thereof free from that disease without vaccination; or (b) comply with the requirements set out in point 1 of Annex V.

6. As regards infection with Brucella abortus, B. melitensis and B. suis, consignments of bovine, ovine and caprine animals shall only be permitted to enter the Union if the animals of the consignment either: (a) originate from a third country or territory or zone thereof free from that disease without vaccination; or (b) comply with the requirements set out in point 2 of Annex V.

7. As regards infection with bluetongue virus (serotypes 1-24), consignments of ungulates of listed species shall only be permitted to enter the Union if the animals of the consignment either: (a) originate from a third country or territory or zone thereof free from that disease for a period of 2 years prior to the date of dispatch to the Union; or (b) comply with one of the specific conditions set out in of Part A of Annex VI.

8. As regards enzootic bovine leukosis, consignments of bovine animals shall only be permitted to enter the Union if those animals either: (a) originate from a third country or territory or zone thereof free from that disease; or (b) comply with the specific conditions set out in Part B of Annex VI.

9. Consignments of ungulates intended for entry into Member States or zones thereof with disease-free status or with an approved eradication programme for the category C diseases referred to in Annex VII, for which the species of ungulates are listed, shall only be permitted to enter the Union if the animals of the consignment: (a) originate from third country or territory or zone thereof free from those diseases for the relevant species; or (b) comply with the relevant additional requirements set out in that Annex.

Article 23

The establishment of origin of ungulates

1. Consignments of ungulates shall only be permitted to enter the Union if the animals of the consignment: (a) come from an establishment in and around which, including where appropriate the territory of a neighbouring country, none of the listed diseases referred to in Annex VIII, for which the species of ungulates intended for entry into the Union are listed, has been reported in an area and for a period set out in the tables in: (i) points 1 and 2 of that Annex for ungulates other than equine animals; or (ii) points 3 and 4 of that Annex for equine animals; (b) during the period referred to in point (a), the ungulates have not come into contact with animals with a lower health status.

2. As regards infection with Mycobacterium tuberculosis complex ( M. bovis , M. caprae, M. tuberculosis ), consignments of bovine, ovine, caprine, camelid and cervid animals shall only be permitted to enter the Union if the establishment of origin of the animals of the consignment complies with the relevant requirements set out in point 1 of Annex IX.

3. As regards infection with Brucella abortus, B. melitensis and B. suis , consignments of bovine, ovine, caprine, porcine, camelid and cervid animals shall only be permitted to enter the Union if the establishment of origin of the animals of the consignment complies with the relevant requirements set out in point 2 of Annex IX.

Article 24

The ungulates of the consignment

1. Consignments of ungulates shall only be permitted to enter the Union if the animals of the consignment comply with the following requirements: (a) they have not been vaccinated against the category A diseases referred to in the tables set out either in: (i) point 1 of Part C of Annex IV in the case of ungulates other than equine animals; or (ii) point 2 of Part C of Annex IV in the case of equine animals; (b) during the period of time from when they were dispatched from their establishment of origin until their arrival to the Union, they must not have been unloaded in any place which does not comply with the requirements laid down in the tables set out either in: (i) points 1 and 2 of Annex VIII in the case of ungulates other than equine animals; or (ii) points 3 and 4 of Annex VIII in the case of equine animals.

2. As regards infection with Mycobacterium tuberculosis complex ( M. bovis , M. caprae, M. tuberculosis ) and infection with Brucella abortus, B. melitensis and B. suis consignments of listed species of ungulates shall only be permitted to enter the Union if the animals of the consignment have not been vaccinated against those diseases.

3. As regards infection with bluetongue virus (serotypes 1-24), consignments of listed species of ungulates shall only be permitted to enter the Union if the animals of the consignment have not been vaccinated with a live vaccine against this disease in the last 60 days prior to the date of movement.

4. Consignments of ungulates intended for entry into Member States or zones thereof with disease-free status or with an approved eradication programme for the category C diseases referred to in Annex VII, for which the species of ungulates are listed, shall only be permitted to enter the Union if the animals of the consignment have not been vaccinated against those diseases.

5. In addition to requirements laid down in paragraph 1, consignments of uncastrated males of ovine animals and ungulates of the family Tayassuidae shall only be permitted to enter the Union if the animals of the consignment comply with the relevant specific requirements as regards infection with Brucella laid down in Annex X.

6. In addition to requirements laid down in paragraph 1, consignments of equine animals shall only be permitted to enter the Union if the animals of the consignment comply with the specific conditions set out in point 2 of Annex XI, depending on the sanitary group, as determined in accordance with point 1 of Annex XI, to which the third country or territory or zone thereof has been assigned in the list.

Article 25

Derogations and additional requirements for entry into the Union of ungulates for slaughter

By way of derogation from the requirements laid down in Article 22(5) and (6), consignments of ungulates of the species referred to in those paragraphs which do not comply with those requirements shall be permitted to enter the Union provided that the animals of the consignment are only intended for slaughter.

▼M2

Article 26

Movement and handling of ungulates after their entry into the Union

Following their entry into the Union, ungulates, except equine animals, shall remain in their establishment of destination for a period of at least 30 days from the date of their arrival in that establishment, unless they are moved for slaughter.

▼B







CHAPTER 2

Special rules for entry into the Union of kept ungulates intended for confined establishments

Article 27

Animal health requirements not applicable to ungulates intended for confined establishments

Articles 11, 22, 23, 24 and 26 shall not apply to consignments of ungulates, excluding equine animals, entering the Union under the conditions laid down in Articles 28 to 34.

Article 28

Specific rules for entry of ungulates intended for confined establishments

1. Consignments of ungulates intended for confined establishments shall only be permitted to enter the Union if the animals of the consignment comply with the following requirements: (a) they must come from a confined establishment which is included in a list of confined establishments from which the entry of ungulates into the Union is permitted, drawn up in accordance with Article 29; (b) they must have been dispatched directly from the confined establishment of origin to a confined establishment in the Union.

2. The competent authority of the Member State of destination shall grant a specific authorisation for entry of each consignment of ungulates referred to in paragraph 1, following the favourable outcome of an assessment of the potential risks that the entry of such consignment may present for the Union.

3. The entry into the Union and the movement of each consignment of ungulates referred to in paragraph 1 through Member States other than the Member State of destination shall be only permitted subject to the authorisation of the competent authorities of those Member States of passage.

That authorisation shall be granted only on the basis of the favourable outcome of a risk assessment carried out by the competent authority of those Member States of passage, based on the information submitted to them by the Member State of the place of destination in the Union.

4. The Member State of the place of destination of the consignments referred to in paragraph 1 shall notify the Commission and the other Member States within the framework of the Standing Committee on Plants, Animals, Food and Feed and notify directly the point of entry in the Union of the ungulates, of the authorisations granted pursuant to paragraph 1 and 2, prior to any possible movement through other Member States and prior to the arrival of such ungulates into their territory.

Article 29

Listing of confined establishments of origin of ungulates in third countries or territories

1. Member States may draw up a list of confined establishments in third countries and territories, from which the entry of ungulates into their territory shall be permitted.

That list shall specify the species of ungulates permitted to enter the territory of the Member State from each confined establishment in the third country or territory.

2. Member States may include in their list of confined establishments provided for in paragraph 1, confined establishments that are already included in such lists of other Member States.

Except as provided for in the first subparagraph, Member States shall only include a confined establishment in a third country or territory in the list of confined establishments provided for in paragraph 1, following the favourable outcome of a complete assessment based on the following:

(a) 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;

(b) 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.

3. Member States shall keep the lists of confined establishments provided for in paragraph 1 up-to-date, taking into account in particular any suspension or withdrawal of the approval granted by the competent authority of a third country or territory of origin as referred to in Article 30, or by the competent authority of another Member State.

4. Member States shall make the lists provided for in paragraph 1 publicly available on their websites.

Article 30

Conditions for confined establishments of origin of ungulates in third countries or territories for the purpose of Article 29

Member States shall only include a confined establishment located in a third country or territory on the list of confined establishments provided for in Article 29, if the confined establishment is approved by the competent authority of the third country or territory and complies with the following conditions:

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

(b) 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;

(c) the animal accommodation areas must be of a suitable standard and constructed in such a way that: (i) contact with animals outside the confined establishment is prevented and inspections and any necessary treatment can be easily carried out; (ii) the floors, walls and all other material or equipment can be cleaned and disinfected easily;

(d) as regards disease surveillance and control measures: (i) it must implement an appropriate disease surveillance programme which must include control measures against zoonosis, and update it according to the number and species of the animals present in the confined establishment and to the epidemiological situation in and around the confined establishment as regards listed diseases and emerging diseases; (ii) it must subject to clinical examinations, laboratory testing or post-mortem examinations those ungulates suspected of being infected or contaminated by disease agents of listed diseases or emerging diseases; (iii) it must carry out, as appropriate, the vaccination and treatment of susceptible ungulates against transmissible diseases;

(e) it must keep, for a minimum period of 3 years, up-to-date records indicating: (i) the number and identity (namely, the estimated age, sex, species and individual identification, where appropriate) of the ungulates of each species present on the confined establishment; (ii) the number and identity (namely, the estimated age, sex, species and individual identification code where appropriate) of ungulates arriving or leaving the confined establishment, together with information on the establishment of origin or destination of such animals, the means of transport and the health status of those animals; (iii) details of the implementation and results of the disease surveillance and control programme provided for in point (d)(i); (iv) the results of clinical examinations, laboratory tests and of post-mortem examinations provided for in point (d)(ii); (v) details of the vaccination and treatment provided for in point (d)(iii); (vi) instructions, if any, of the competent authority of the third country or territory of origin as regards observations made during any period of isolation or quarantine;

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

(g) it must secure by contract or other legal instrument the services of an establishment veterinarian who shall be responsible for: (i) the supervision of the activities of the establishment and compliance with the conditions for approval laid down in of this Article; (ii) the review of the disease surveillance programme referred to in point (d)(i) at least annually;

(h) by way of derogation from Article 9(c), either has: (i) an arrangement with a laboratory approved by the competent authority of the third country or territory to perform post-mortem examinations; or (ii) one or more appropriate premises where post-mortem examinations may be performed under the authority of the establishment veterinarian.

Article 31

Derogation from the requirement of listing of the third country or territory and the listing of the confined establishment of origin of ungulates

1. By way of derogation from the requirements laid down Article 3(1) and Article 28(1), consignments of ungulates from establishments in third countries or territories which do not comply with those requirements shall be permitted to enter the Union if they are intended for a confined establishment and provided that: (a) exceptional unforeseen circumstances render compliance with those requirements impossible; (b) those consignments comply with the conditions laid down in Article 32.

2. The Member State of the place of destination of the consignment referred to in paragraph 1 shall notify the Commission and the Member States within the framework of the Standing Committee on Plants, Animals, Food and Feed and notify directly the point of entry in the Union of the ungulates, of the authorisations granted pursuant to paragraph 1, prior to any possible movement through other Member States and prior to the arrival of such ungulates into their territory.

Article 32

Additional requirements to be fulfilled by establishments of origin of ungulates intended for a confined establishment pursuant to the derogation laid down in Article 31

The competent authority of a Member State of destination shall only authorise derogations, as provided for in Article 31, for consignments of ungulates that comply with the following additional conditions:

(a) 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;

(b) 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: (i) at a place approved by the competent authority of the third country or territory of origin of the ungulates; (ii) in accordance with the arrangements specified in the authorisation referred to in point (a) that must provide at least the same guarantees as those provided for by Article 28(2) to (4) and by Articles 33 and 34;

(c) 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.

Article 33

Animal health requirements for the confined establishment of origin of ungulates as regards listed diseases

Consignments of ungulates intended for a confined establishment located in the Union shall only be permitted to enter the Union if the confined establishment of origin complies with the following requirements as regards listed diseases:

(a) 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;

(b) 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.

Article 34

Animal health requirements for the ungulates of the consignment as regards listed diseases

Consignments of ungulates intended for a confined establishment located in the Union shall only be permitted to enter the Union if the animals of the consignment comply with the following additional animal health requirements:

(a) 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;

(b) they must not have been in contact with animals of a lower health status during: (i) the period of 30 days prior to the date of dispatch to the Union, or since birth if the animals are less than 30 days of age; (ii) their transport from the approved confined establishment of origin to the place of dispatch to the Union;

(c) as regards the diseases referred to in the table set out in Part C of Annex XII, they must either: (i) originate from a third country or territory or zone thereof which complies with the disease freedom periods for the relevant diseases set out in that table; or (ii) comply with the relevant additional requirements set out in Part D of Annex XII;

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

(e) 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;

(f) 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.

Where the specific guarantees referred to in point (c)(ii) include a quarantine period in a vector-protected facility in the confined establishment, this facility must comply with the requirements set out in Part F of Annex XII.

Article 35

Movement and handling of ungulates intended to confined establishments after the entry

Following their entry into the Union, ungulates originating from a confined establishment in a third country or territory, as referred to in Article 27, must remain in the confined establishment of destination for a period of at least 6 months prior to the date of movement to another confined establishment in the Union, unless they are exported from the Union or moved for slaughter.







TITLE 3

ANIMAL HEALTH REQUIREMENTS FOR POULTRY AND CAPTIVE BIRDS







CHAPTER 1

Specific animal health requirements for poultry







SECTION 1

ANIMAL HEALTH REQUIREMENTS FOR ALL SPECIES AND CATEGORIES OF POULTRY

Article 36

Poultry imported into the third country or territory of origin or zone thereof prior to entry into Union

1. The following consignments shall only be permitted to enter the Union where the competent authority of the third country or territory of origin has provided guarantees in accordance with paragraph 2: (a) poultry imported into the third country or territory of origin or zone thereof from another third country or territory or zone thereof; (b) day-old chicks from parent flocks that were imported into the third country or territory of origin or zone thereof from another third country or territory or zone thereof.

2. Consignments of animals referred to in paragraph 1 shall only be permitted to enter the Union if the competent authority of the third country or territory of origin of the poultry has provided guarantees that: (a) those poultry and parent flocks referred to in that paragraph were imported from a third country or territory or zone thereof, which is listed for entry into Union of such consignments; (b) the import of the poultry and parent flocks referred to paragraph 1 into that third country or territory or zone thereof took place in accordance with animal health requirements that are at least as stringent as those applicable to consignments of those animals entering directly into the Union.

Article 37

Requirements concerning the third country or territory of origin of poultry or zone thereof

Consignments of poultry shall only be permitted to enter the Union if such consignments originate from a third country or territory or zone thereof which complies with the following requirements:

(a) 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: (i) Annex II to this Regulation; or (ii) the relevant Chapter of the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE);

(b) it is considered to be free from highly pathogenic avian influenza in accordance with Article 38;

(c) where it carries out vaccination against highly pathogenic avian influenza, the competent authority of the third country or territory of origin has provided guarantees that: (i) the vaccination programme complies with the requirements set out in Annex XIII; (ii) the surveillance programme referred to in point (a) of this Article, in addition to the requirements set out in Annex II, complies with the requirements set out in point 2 of Annex XIII; (iii) it has undertaken to inform the Commission of any change to the vaccination programme in the third country or territory or zone thereof;

(d) which: (i) in the case of poultry other than ratites, it is considered free from infection with Newcastle disease virus in accordance with Article 39; (ii) in the case of ratites: — it is considered free from infection with Newcastle disease virus in accordance with Article 39, or — it is not considered free from infection with Newcastle disease virus in accordance with Article 39, but the competent authority of the third country or territory of origin has provided guarantees regarding compliance with the requirements for infection with Newcastle disease virus in relation to isolation, surveillance and testing, as set out in Annex XIV;

(e) where vaccination against infection with Newcastle disease virus is carried out, the competent authority of the third country or territory has provided guarantees that: (i) the vaccines used comply with the general and the specific criteria for vaccines against infection with Newcastle disease virus set out in point 1 of Annex XV; or (ii) the vaccines used comply with the general criteria for vaccines against infection with Newcastle disease virus set out in point 1 of Annex XV and the poultry meet the animal health requirements set out in point 2 of Annex XV for poultry and hatching eggs originating from a third country or territory or zone thereof where vaccines used against infection with Newcastle disease virus do not meet the specific criteria set out in point 1 of Annex XV;

(f) 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: (i) information on the disease situation within 24 hours of confirmation of any initial outbreak of highly pathogenic avian influenza or infection with Newcastle disease virus; (ii) regular updates on the disease situation;

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

Article 38

Freedom from highly pathogenic avian influenza of the third country or territory of origin or zone thereof

1. A third country or territory or zone thereof shall be considered as being free from highly pathogenic avian influenza when it has provided the following guarantees to the Commission: (a) a surveillance programme for highly pathogenic avian influenza, in accordance with Article 37(a) has been carried out during a period of at least 6 months preceding the date of certification of the consignment by the official veterinarian for dispatch to the Union; (b) no outbreak of highly pathogenic avian influenza has occurred in poultry in that third country or territory or zone thereof for a period of at least 12 months preceding the date of certification of the consignment by the official veterinarian for dispatch to the Union.

2. Following an outbreak of highly pathogenic avian influenza in a third country or territory or zone thereof previously considered as free of that disease, as referred to in paragraph 1, that third country or territory or zone thereof shall again be considered as free from highly pathogenic avian influenza, subject to compliance with the following conditions: (a) a stamping out policy has been implemented to control highly pathogenic avian influenza; (b) adequate cleaning and disinfection has been carried out on all previously infected establishments; (c) during a period of at least 3 months following the completion of the stamping out policy and cleaning and disinfection referred to in points (a) and (b), the competent authority of the third country or territory has carried out a surveillance programme, providing 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), with negative results.

Article 39

Freedom from infection with Newcastle disease virus of the third country or territory of origin or zone thereof

1. A third country or territory or zone thereof shall be considered free from infection with Newcastle disease virus when no outbreak of infection with Newcastle disease virus has occurred in poultry in that third country or territory or zone thereof for a period of at least 12 months preceding the date of certification of the consignment by the official veterinarian for dispatch to the Union.

2. When an outbreak of infection with Newcastle disease virus occurs in a third country or territory or zone thereof previously free from that disease, as referred to in paragraph 1, that third country or territory or zone thereof shall again be considered as free from that infection with Newcastle disease virus subject to compliance with the following conditions: (a) a stamping out policy has been implemented to control the disease; (b) adequate cleaning and disinfection has been carried out on all previously infected establishments; (c) during a period of at least 3 months following the completion of the stamping out policy and cleaning and disinfection referred to in points (a) and (b), the competent authority of the third country or territory has demonstrated the absence of that disease in the third country or territory or zone thereof by intensified investigations including laboratory testing in relation to the outbreak.

Article 40

The establishment of origin of poultry

1. Consignments of breeding poultry and productive poultry shall only be permitted to enter into the Union if the animals of the consignment come from establishments approved by the competent authority of the third country or territory of origin in accordance with requirements which are at least as stringent as to those laid down in Article 8 of Delegated Regulation (EU) 2019/2035, and: (a) the approval of which has not been suspended or withdrawn; (b) within a 10 km radius of which, including, where appropriate, the territory of a neighbouring country, there has been no outbreak of highly pathogenic avian influenza or infection with Newcastle disease virus during the period of at least 30 days prior to the date of loading for dispatch to the Union; (c) in which no confirmed case of infection with low pathogenic avian influenza viruses has been reported during the period of at least 21 days prior to the date of loading for dispatch to the Union.

2. Consignments of poultry intended for slaughter shall only be permitted to enter into the Union if the animals of the consignment come from establishments: (a) within a 10 km radius of which, including, where appropriate, the territory of a neighbouring country, there has been no outbreak of highly pathogenic avian influenza or infection with Newcastle disease virus during the period of at least 30 days prior to the date of loading for dispatch to the Union; (b) in which no confirmed case of infection with low pathogenic avian influenza viruses has been reported during the period of at least 21 days prior to the date of loading for dispatch to the Union.

3. Consignments of day-old chicks shall only be permitted to enter into the Union if the animals of the consignment: (a) have been hatched in establishments approved by the competent authority of the third country or territory of origin in accordance with requirements which are at least as stringent as to those laid down in Article 7 of Delegated Regulation (EU) 2019/2035; and (i) the approval of which has not been suspended or withdrawn; (ii) within a 10 km radius of which, including, where appropriate, the territory of a neighbouring country, there has been no outbreak of highly pathogenic avian influenza or infection with Newcastle disease virus during the period of at least 30 days prior to the date of dispatch to the Union; (b) come from 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 as stringent as to those laid down in Article 8 of Delegated Regulation (EU) 2019/2035, and (i) the approval of which had not been suspended or withdrawn at the time the hatching eggs, from which the day-old chick were hatched, were sent to the hatchery; (ii) in which no confirmed case of infection with low pathogenic avian influenza viruses has been reported during the period of at least 21 days prior to the date of collection of the hatching eggs from which the day-old chicks were hatched.

Article 41

Specific preventive measures for the containers in which poultry are transported

Consignments of poultry shall only be permitted to enter into the Union if such consignments have been transported in containers which, in addition to the requirements of Article 18, comply with the following requirements:

(a) they are closed in accordance with the instructions of the competent authority of the third country or territory of origin in order to avoid any possibility of substitution of the contents;

(b) they bear the information for the particular species and category of poultry set out in Annex XVI;

(c) in the case of day-old chicks, they are disposable, clean and used for the first time.

Article 42

Entry of poultry into Member States with status free from infection with Newcastle disease virus without vaccination

1. Consignments of breeding poultry and productive poultry intended for a Member State with status free from infection with Newcastle disease virus without vaccination shall only be permitted to enter into the Union if the animals of the consignment comply with the following requirements: (a) they have not been vaccinated against infection with Newcastle disease virus; (b) they have been kept in isolation during a period of at least 14 days prior to the date of loading of the consignment for dispatch to the Union in the establishment of origin or quarantine establishment under the supervision of an official veterinarian, where: (i) no poultry has been vaccinated against infection with Newcastle disease virus during a period of at least 21 days prior to the date of loading of the consignment; (ii) no bird which does not form part of the consignment has entered into the establishment during period referred to in point (i); (iii) no vaccination has been carried out; (c) they have tested negative, during the period of at least 14 days prior to the date of loading for dispatch to the Union, to serological tests to detect antibodies against Newcastle disease virus, performed on blood samples at a level which gives 95 % confidence of detecting infection at 5 % prevalence.

2. Consignments of poultry intended for slaughter intended for a Member State with status free from infection with Newcastle disease virus without vaccination, shall only be permitted to enter into the Union if the animals of the consignment come from flocks which: (a) have not been vaccinated against infection with Newcastle disease virus and have tested negative, during a period of at least 14 days prior to the date of loading of the consignment for dispatch to the Union, to serological tests to detect antibodies against Newcastle disease virus performed on blood samples at a level which gives 95 % confidence of detecting infection at 5 % prevalence; or (b) have been vaccinated against infection with Newcastle disease virus but not with a live vaccine during the period of at least 30 days prior to the date of loading of the consignment for dispatch to the Union and underwent a virus isolation test for infection with Newcastle disease virus in the 14 days prior to that date on a random sample of cloacal swabs or faeces samples taken from at least 60 birds and tested negative.

3. Consignments of day-old chicks intended for a Member State with status free from infection with Newcastle disease virus without vaccination shall only be permitted to enter into the Union if the animals of the consignment: (a) have not been vaccinated against infection with Newcastle disease virus; (b) come from hatching eggs coming from flocks which comply with one of the following: (i) they have not been vaccinated against infection with Newcastle disease virus; or (ii) they have been vaccinated against infection with Newcastle disease virus using an inactivated vaccine; or (iii) they have been vaccinated against infection with Newcastle disease virus using a live vaccine at the latest 60 days prior to the date the eggs were collected; (c) come from a hatchery where working practices ensure that the eggs of day-old chicks intended for entry into the Union are incubated at completely separate times and locations from eggs not satisfying the requirements laid down in point (b).







SECTION 2

SPECIFIC ANIMAL HEALTH REQUIREMENTS FOR BREEDING AND PRODUCTIVE POULTRY

Article 43

Identification of breeding ratites and productive ratites

Consignments of breeding ratites and productive ratites shall only be permitted to enter into the Union if the animals of the consignment are individually identified by neck-tags or an injectable transponder:

(a) with the code of the third country or territory of origin conforming with ISO Standard 3166 in the format of two-letter;

(b) which comply with ISO standards 11784 and 11785.

Article 44

Specific animal health requirements for the flock of origin of consignments of breeding and productive poultry

Consignments of breeding poultry and productive poultry shall only be permitted to enter into the Union if the animals of the consignment originate from flocks which comply with the following requirements:

(a) the flocks have not been vaccinated against highly pathogenic avian influenza;

(b) if the flocks have been vaccinated against infection with Newcastle disease virus: (i) guarantees have been provided by the competent authorities of the third country or territory of origin that the vaccines used comply either with: — the general and the specific criteria for vaccines against infection with Newcastle disease virus set out in point 1 of Annex XV, or — the general criteria for vaccines against infection with Newcastle disease virus set out in point 1 of Annex XV, and the poultry meet the animal health requirements set out in point 2 of Annex XV for poultry and hatching eggs originating from a third country or territory or zone thereof where vaccines used against infection with Newcastle disease virus do not meet the specific criteria set out in point 1 of Annex XV; (ii) the information set out in point 4 of Annex XV must be provided for the consignment;

(c) the flocks have undergone a disease surveillance programme that meets the requirements set out in Annex II of Delegated Regulation (EU) 2019/2035, and were found not to be infected or showed any ground for suspecting any infection by the following agents: (i) Salmonella Pullorum, Salmonella Gallinarum and Mycoplasma gallisepticum in case of Gallus gallus; (ii) Salmonella arizonae (serogroup O:18(k)), Salmonella Pullorum, Salmonella Gallinarum, Mycoplasma meleagridis and Mycoplasma gallisepticum in case of Meleagris gallopavo; (iii) Salmonella Pullorum and Salmonella Gallinarum in case of Numida meleagris, Coturnix coturnix, Phasianus colchicus, Perdix perdix, Anas spp.;

(d) the flocks are 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 loading of the consignment for dispatch to the Union have applied the following measures: (i) the infected flock has been slaughtered or it has been killed and destroyed; (ii) following the slaughter or killing of the infected flock referred to in point (i), the establishment has been cleaned and disinfected; (iii) following the cleaning and disinfection referred to in point (ii), all flocks on the establishment tested negative for infection with Salmonella Pullorum, S. Gallinarum and S. arizonae in two tests performed with an interval of at least 21 days in accordance with the disease surveillance programme referred to in point (c);

(e) the flocks are 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 loading of the consignment for dispatch to the Union have applied the following measures: either (i) the infected flock tested negative for avian mycoplasmosis (Mycoplasma gallisepticum and M. meleagridis) in two tests performed in accordance with the disease surveillance programme referred to in point (c) on the entire flock with an interval of at least 60 days; or (ii) the infected flock has been slaughtered or it has been killed and destroyed, the establishment has been cleaned and disinfected and following the cleaning and disinfection all flocks on the establishment tested negative for avian mycoplasmosis (Mycoplasma gallisepticum and M. meleagridis) in two tests performed with an interval of at least 21 days in accordance with the disease surveillance programme referred to in point (c).







SECTION 3

SPECIFIC ANIMAL HEALTH REQUIREMENTS FOR POULTRY INTENDED FOR SLAUGHTER

Article 45

Specific animal health requirements for the flock of origin of consignments of poultry intended for slaughter

Consignments of poultry intended for slaughter shall only be permitted to enter into the Union if the animals of the consignment originate from flocks which comply with the following requirements:

(a) they have not been vaccinated against highly pathogenic avian influenza;

(b) if they have been vaccinated against infection with Newcastle disease virus: (i) guarantees have been provided by the competent authority of the third country or territory of origin that: — the vaccines used comply with the general and the specific criteria for vaccines against infection with Newcastle disease virus set out in point 1 of Annex XV, or — the vaccines used comply with the general criteria for vaccines against infection with Newcastle disease virus set out in point 1 of Annex XV and the poultry meet the animal health requirements set out in point 2 of Annex XV for poultry and hatching eggs originating from a third country or territory or zone thereof where vaccines used against infection with Newcastle disease virus do not meet the specific criteria set out in point 1 of Annex XV; (ii) the information set out in point 4 of Annex XV must be provided for each consignment.







SECTION 4

SPECIFIC ANIMAL HEALTH REQUIREMENTS FOR DAY-OLD CHICKS

Article 46

Specific animal health requirements for the flocks of origin of consignments of day-old chicks

Consignments of day-old chicks shall only be permitted to enter into the Union if the animals of the consignment originate from flocks which comply with the following requirements:

(a) if the flocks 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;

(b) if the flocks have been vaccinated against infection with Newcastle disease virus: (i) guarantees have been provided by the competent authority of the third country or territory of origin that the vaccines used comply either with: — the general and the specific criteria for vaccines against infection with Newcastle disease virus set out in point 1 of Annex XV, or — the general criteria for recognised vaccines against infection with Newcastle disease virus set out in point 1 of Annex XV and the poultry and hatching eggs from which the day-old chicks originated meet the animal health requirements set out in point 2 of Annex XV for poultry and hatching eggs originating from a third country or territory or zone thereof where vaccines used against infection with Newcastle disease virus do not meet the specific criteria set out in point 1 of Annex XV; (ii) the information set out in point 4 of Annex XV must be provided for each consignment;

(c) the flocks have undergone a disease surveillance programme that meets the requirements set out in 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: (i) Salmonella Pullorum, Salmonella Gallinarum and Mycoplasma gallisepticum in case of Gallus gallus; (ii) Salmonella arizonae (serogroup O:18(k)), Salmonella Pullorum, Salmonella Gallinarum, Mycoplasma meleagridis and Mycoplasma gallisepticum in case of Meleagris gallopavo; (iii) Salmonella Pullorum and Salmonella Gallinarum in case of Numida meleagris, Coturnix coturnix, Phasianus colchicus, Perdix perdix, Anas spp.;

(d) the flocks are 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 loading of the consignment for dispatch to the Union have applied the following measures: (i) the infected flock has been slaughtered or it has been killed and destroyed; (ii) following the slaughter or killing of the infected flock referred to in point (i), the establishment has been cleaned and disinfected; (iii) following the cleaning and disinfection referred to in point (ii), all flocks on the establishment tested negative for infection with Salmonella Pullorum, S. Gallinarum and S. arizonae in two tests performed with an interval of at least 21 days in accordance with the disease surveillance programme referred to in point (c);

(e) the flocks are 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 loading of the consignment for dispatch to the Union have applied the following measures: either (i) the infected flock tested negative for avian mycoplasmosis (Mycoplasma gallisepticum and M. meleagridis) in two tests performed in accordance with the disease surveillance programme referred to in point (c) on the entire flock with an interval of at least 60 days; or (ii) the infected flock has been slaughtered or it has been killed and destroyed, the establishment has been cleaned and disinfected and following the cleaning and disinfection all flocks on the establishment tested negative for avian mycoplasmosis (Mycoplasma gallisepticum and M. meleagridis) in two tests performed with an interval of at least 21 days in accordance with the disease surveillance programme referred to in point (c).

Article 47

Specific animal health requirements for the hatching eggs of origin of consignments of day-old chicks

Consignments of day-old chicks shall only be permitted to enter into the Union if the animals of the consignment originate from hatching eggs which:

(a) comply with the animal health requirements for entry into the Union laid down in Title 2 of Part III;

(b) prior to being dispatched to the hatchery, the hatching eggs had been marked in accordance with the instruction of the competent authority;

(c) had been disinfected in accordance with the instructions of the competent authority;

(d) have had no contact with poultry or hatching eggs of a lower health status, captive birds or wild birds, either during transport to the hatchery or in the hatchery.

Article 48

Specific animal health requirements for the day-old chicks

Consignments of day-old chicks shall only be permitted to enter into the Union if the animals of the consignment have not been vaccinated against avian influenza.







SECTION 5

SPECIFIC ANIMAL HEALTH REQUIREMENTS FOR LESS THAN 20 HEADS OF POULTRY

Article 49

Derogation and specific requirements for consignments of less than 20 heads of poultry, other than ratites

▼M2

By way of derogation from Article 14(3), Article 40 and Articles 43 to 48, consignments containing less than 20 heads of poultry other than ratites, shall be permitted to enter the Union provided that such consignments comply with the following requirements:

▼B

(a) the poultry come from establishments where: (i) no confirmed case of infection with low pathogenic avian influenza viruses has been reported during the period of at least 21 days prior to date of loading of the consignment for dispatch to the Union or the date of collection of the hatching eggs from which the day-old chicks were hatched; (ii) within a 10 k