CELEX: 
Language: en
Date: 2020-01-30 00:00:00
Title: COMMISSION DELEGATED REGULATION (EU) …/... 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

EUROPEAN
                             COMMISSION
                                                      Brussels, 30.1.2020
                                                      C(2020) 416 final
                 COMMISSION DELEGATED REGULATION (EU) …/...
                                          of 30.1.2020
      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)
EN                                                                                        EN
 ---pagebreak---                               EXPLANATORY MEMORANDUM
   1.  CONTEXT OF THE DELEGATED ACT
       Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March
       2016 on transmissible animal diseases and amending and repealing certain acts in the
       area of animal health (‘Animal Health Law1’) lays down rules on transmissible
       animal diseases. In particular, Chapter 1 of Part V lays down the animal health
       requirements for entry into the Union, and the movement and handling after entry, of
       consignments of animals, germinal products and products of animal origin from third
       countries and territories.
       The Animal Health Law empowers the Commission to adopt delegated acts
       supplementing those rules.
       Thus, in the interests of consistency and transparency and to avoid duplications, it is
       important that these rules are laid down in the same delegated act as they are all
       interrelated, and in many cases are applied in tandem.
       The rules laid down in this Regulation largely replicate rules currently laid down in
       existing Union acts as they have proven effective in preventing the spread of listed
       diseases into and within the Union. As stated above, the focus of these rules is on
       setting out the animal health requirements for entry into the Union, and movement
       and handling after entry, of consignments of animals, germinal products and products
       of animal origin from third countries and territories.
       However, this Regulation adopts a general and unique approach to laying down
       animal health requirements for entry into the Union of such consignments, as it takes
       account of newly available scientific knowledge and the experience gained in
       applying existing Union rules in this domain. It also updates animal health rules in
       line with the new Union animal health policy framework and international standards.
       Thus, it offers more clarity, transparency and consistency in the requirements for
       entry into the Union of such consignments.
       More specifically, this Regulation lays down the rules for entry into the Union, and
       on movements and handling after entry of the following:
       (a)    kept ungulates, poultry, captive birds, dogs, cats, ferrets, honeybees and
              bumble bees;
       (b)    germinal products of certain species of ungulates and hatching eggs of poultry
              and captive birds;
       (c)    fresh meat of ungulates, poultry and game birds;
       (d)    meat products obtained from fresh meat of ungulates, poultry and game birds;
       (e)    milk, colostrum, dairy products and colostrum-based products from ungulates;
       (f)    products of animal origin contained in composite products;
       (g)    products of animal origin intended for personal use;
       (h)    certain species of aquatic animals at all life stages, including eggs, sperm and
              gametes, as well as their products of animal origin.
   1
      OJ L 84, 31.3.2016, p. 1.
EN                                            1                                                EN
 ---pagebreak---       It also lays down general rules and derogations for transit through the Union and re-
      entry into the Union of consignments of animals, germinal products and products of
      animal origin.
   2. CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT
      The Commission had several meetings and exchanges with the Expert Group on
      animal health (E00930). The draft delegated regulation was also made available to
      the European Parliament and the Council, with neither institution making any
      comments. A number of meetings were held with a range of stakeholders as part of
      the Animal Health Advisory Committee, in which the main elements of the draft act
      were illustrated and discussed.
      The main elements of the draft act were presented in the World Trade Organization –
      Sanitary and Phytosanitary Committee (WTO-SPS) meeting of 21 March 2019, and
      the draft regulation was sent to that Committee for notification in July 2019. WTO
      member countries had 2 months in which to send their comments.
      In addition, stakeholders’ comments on the draft delegated regulation were collected
      in the context of the Better Regulation feedback mechanism during the period
      between 17 June and 12 July 2019. 27 feedbacks were received in total, including
      opinions of the following stakeholders: European Live Poultry and Hatching Egg
      Association (ELPHA) and the European Poultry Breeders Association (EPB) (BE),
      Comité Interprofessionnel des Produits de l'Aquaculture (FR), Fédération Française
      d'Equitation (FR), Four associations representing the European Thoroughbred Racing
      & Breeding (EMSBLC) (IE), Dibevo (NL), British Equestrian Federation (UK),
      European Federation for Animal Health and Sanitary Security (FESASS) (BE),
      UECBV (European Livestock and Meat Trades Union) (BE), GDS FRANCE (FR),
      International Pet & Animal Transportation Association (IPATA) (US), European
      Association of Zoos and Aquaria (EAZA) (NL), National Pig Association (UK),
      British Poultry Council (UK), National Farmers' Union (NFU) (UK), World Horse
      Welfare (UK), NFU Scotland (UK), Ulster Farmers' Union (UK), Dogs Trust (UK),
      Stallion AI Services/ Cryogenetics Ltd, Federation of Veterinarians of Europe (BE),
      1 from an Academic/research institution (US), 3 public authorities (BE, AU and
      UK), 1 particular citizen and 4 from anonymous.
      The main requests submitted and points made were the following:
      –      the request to include certain definitions laid down in Regulation (EU)
             2016/429 and Regulation (EU) 2017/625 in order to ensure an identical
             understanding throughout the Union and trading partners. The definitions laid
             down in those Regulations apply by default as they are basic acts and only
             supplementary definitions must be included in the tertiary legislation.
      –      the request to reconsider the level of requirements in relation to the control of
             emerging diseases in third countries;
      –      the suggestion to add extra requirements regarding the compliance with other
             EU rules (i.e. rules on responsible use of medicines and on animal welfare).
             Those rules apply by default in addition to the Animal Health Law and the
             supplementing legislation;
      –      the request to include electronic identification for ungulates intended for
             confined establishments;
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 ---pagebreak---       –    the request to clarify the periodicity of the animal health visits in the
           establishment of origin of animals;
      –    the request to extend the period to perform the inspection of animals prior to
           their dispatch to the Union in certain species and categories of animals;
      –    the request for a derogation regarding visible, legible and indelible
           identification display for ungulates intended for confined establishments.
   3. LEGAL ELEMENTS OF THE DELEGATED ACT
      This Commission Delegated Regulation is to be adopted pursuant to Regulation (EU)
      2016/429, and in particular Articles 234, 237 and 239 thereof.
EN                                          3                                             EN
 ---pagebreak---                     COMMISSION DELEGATED REGULATION (EU) …/...
                                            of 30.1.2020
       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)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of
   9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the
   area of animal health (‘Animal Health Law’)2, and in particular Articles 234(2), 237(4) and
   239(2) thereof,
   Whereas:
   (1)    Union legislation in the area of animal health was recently updated by the adoption of
          the ‘Animal Health Law’. That Regulation, which came into force on 20 April 2016,
          and which applies from 21 April 2021, repealed and replaced around 40 basic acts. It
          also requires the adoption of many Commission delegated and implementing
          regulations to repeal and replace around 400 Commission acts that existed in the area
          of animal health before the new legal framework established by the ‘Animal Health
          Law’.
   (2)    Trading conditions have evolved since the adoption of the first animal health rules at
          Union level, with the volume of trade in animals, germinal products and products of
          animal origin increasing significantly, both within the Union and with third countries.
          During the same period, as a result of Union animal health policies and rules, certain
          diseases have been eradicated in the Union and other diseases have been prevented or
          controlled in many Member States. However, on several occasions, emerging diseases
          have posed new challenges for the Union animal health status, trade and the local
          economy in the areas affected by those diseases.
   (3)    The rules laid down in this act, supplement those already laid down in the ‘Animal
          Health Law’. They should provide the necessary guarantees to ensure that
          consignments of animals, germinal products and products of animal origin entering the
          Union do not present an animal health risk for kept and wild animals that could
          jeopardise the Union health status as regards animal diseases and have a detrimental
          economic impact on the sectors involved.
   (4)    Article 234 of the ‘Animal Health Law’ provides that pending the adoption of
          delegated acts laying down animal health requirements as regards a particular species
          and category of animal, germinal product or product of animal origin, Member States
          may, following evaluation of the risks involved, apply national rules if they comply
   2
          OJ L 84, 31.3.2016, p. 1.
EN                                                4                                               EN
 ---pagebreak---         with certain requirements laid down in that Regulation. Therefore, the entry into the
        Union of species and categories of animals, germinal products and products of animal
        origin not covered by this Regulation may be subject to such national rules applied by
        Member States.
   (5)  The existing animal health rules, laid down in previous Commission acts concerning
        the entry into the Union of animals, germinal products and products of animal origin
        have proved to be effective, therefore the aim and substance of those existing rules
        should be maintained in this Regulation, but updated to take account of the rules on
        better regulation, of the new animal health framework laid down in the ‘Animal Health
        Law’ and of newly available scientific knowledge, international standards and
        experience in applying previous Union acts.
   (6)  To avoid unnecessary trade disruptions, the animal health requirements for entry into
        the Union of consignments falling within the scope of this Regulation should ensure a
        smooth transition from the requirements laid down in pre-existing Union acts.
   (7)  The ‘Animal Health Law’ lays down rules for the prevention and control of animal
        diseases transmissible to animals or to humans. In particular, Chapter 1 of Part V of
        that Regulation, which lays down the animal health requirements for entry into the
        Union of consignments of animals, germinal products and products of animal origin,
        provides for the Commission to adopt delegated acts to supplement the animal health
        requirements already laid down in it.
   (8)  Article 229(1) of the ‘Animal Health Law’ lays down the requirements under which
        Member States are to permit the entry into the Union of consignments of animals,
        germinal products and products of animal origin. The requirements cover conditions
        concerning the third country or territory of origin, the establishment of origin, the
        animal health requirements that those consignments are required to comply with, as
        well as the animal health certificate, declarations or other document that should
        accompany such consignments.
   (9)  In addition, Article 234(1) of the ‘Animal Health Law’ stipulates that the animal
        health requirements for entry into the Union of consignments of species and categories
        of animals, germinal products and products of animal origin from third countries or
        territories or zones thereof must be at least as stringent as those laid down in that
        Regulation, and in delegated acts adopted pursuant to it, applicable to movements
        within the Union of those species and categories of those commodities. If the
        requirements are not as stringent as those in the Regulation, they must offer equivalent
        guarantees to the animal health requirements provided for in Part IV of that
        Regulation.
   (10) Article 234(2) of the ‘Animal Health Law’ provides for delegated acts to be adopted to
        supplement the rules laid down in that Regulation, as regards the animal health
        requirements for entry into the Union of species and categories of animals, germinal
        products and products of animal origin from third countries and territories, and for the
        movement within the Union and handling of those commodities after their entry into
        the Union, in order to mitigate the possible risks involved.
   (11) Article 237(1) of the ‘Animal Health Law’ provides that Member States are only to
        permit the entry into the Union of consignments of animals, germinal products and
        products of animal origin if such consignments are accompanied by the animal health
        certificates and the declarations or other documents required under that Regulation.
        Article 237(2) of that Regulation stipulates that the animal health certificate must have
EN                                              5                                                 EN
 ---pagebreak---         been verified and signed by an official veterinarian in the third country or territory of
        origin. In this context, Article 237(4) of the ‘Animal Health Law’ provides for the
        Commission to adopt delegated acts concerning derogations from the animal health
        certificate requirements laid down in Article 237(1) and Article 237(2) of that
        Regulation, and to lay down rules requiring such consignments to be accompanied by
        declarations or other documents.
   (12) Article 239(2) of the ‘Animal Health Law’ provides for the Commission to adopt
        delegated acts concerning special rules and additional requirements for certain specific
        types of entry into the Union of consignments of animals, germinal products and
        products of animal origin, and provides for derogations from the general animal health
        requirements laid down in Articles 229(1) and 237(1) of that Regulation, and in the
        supplementing rules laid down in delegated acts adopted pursuant to Articles 234(2)
        and 237(4) thereof.
   (13) The supplementing rules to be laid down in this Regulation pursuant to Articles 234(2)
        and 239(2) of the ‘Animal Health Law’ are interrelated. Article 234(2) provides for the
        Commission to lay down the general requirements for entry into the Union of
        consignments of animals, germinal products and products of animal origin, while
        Article 239(2) provides for the Commission to lay down the special rules and
        additional requirements for derogations from those general requirements.
   (14) The animal health certificate requirements provided for in Article 237 of the ‘Animal
        Health Law’ are part of the framework of rules relating to the entry into the Union of
        consignments of animals, germinal products and products of animal origin. The
        empowerment granted to the Commission under Article 237(4) of that Regulation to
        grant derogations from the animal health requirements is part of that general
        framework of rules.
   (15) The ‘Animal Health Law’ already provides a number of definitions. In addition, this
        Regulation should also have regard to the definitions laid down in other Union acts in
        the related areas of food hygiene and official controls, such as the definitions laid
        down in Regulation (EC) 853/20043. However, for the purpose of laying down the
        animal health requirements for entry into the Union of animals, germinal products and
        products of animal origin it is appropriate to include particular definitions, including
        definitions for certain categories of animals, germinal products and products of animal
        origin. These definitions are needed to clarify which categories of animals, germinal
        products and products of animal origin represent an animal health risk and are
        therefore subject to the animal health requirements for entry into the Union.
   (16) In the interests of consistency of Union legislation, and based on the animal health risk
        they represent, the definition for ‘fresh meat’ for the purpose of this Regulation should
        incorporate the definitions for ‘fresh meat’, ‘minced meat’ and ‘meat preparations’
        laid down in Annex I to Regulation (EC) 853/2004.
   (17) In addition, the definition for ‘meat products’ for the purpose of this Regulation should
        incorporate the definitions for ‘meat products’, ‘treated stomachs’, ‘bladders’,
        ‘intestines’, ‘rendered animal fats’ and ‘meat extracts’ laid down in Regulation (EC)
        853/2004. This is because from an animal health point of view, all of those
        commodities represent the same animal health risk and should be subjected to the
        same risk-mitigating measures.
   3
        Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying
        down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55).
EN                                                    6                                                   EN
 ---pagebreak---    (18) The definition for ‘carcase’ laid down in Regulation (EC) 853/2004 should be adapted
        to define ‘carcase of an ungulate’ in order to differentiate it from ‘offal’. This is
        because those two commodities represent different animal health risks, with 'offal'
        representing a higher risk.
   (19) ‘Casings’ should be defined in this Regulation and that definition should take into
        account the definition included in the glossary of the Terrestrial Animal Health Code
        of the World Organisation for Animal Health (OIE). The definition should clarify
        which products of animal origin must be considered as casings and therefore undergo
        the specific risk-mitigating treatments provided for in this Regulation.
   (20) Article 229(1) of the ‘Animal Health Law’ provides that consignments of animals,
        germinal products and products of animal origin are only to be permitted to enter into
        the Union if they come from third countries or territories listed for entry into the
        Union of the particular species and category of animals, germinal products or products
        of animal origin, in accordance with the criteria laid down in Article 230(1), and if the
        consignments comply with the animal health requirements provided for in Article 234
        and subsequent delegated acts. This Regulation should make it the responsibility of the
        competent authority to verify that such consignments entering the Union comply with
        those requirements.
   (21) Article 237(1) the ‘Animal Health Law’ provides that the entry into the Union of
        consignments of species and categories of animals, germinal products and products of
        animal origin from third countries or territories is only to be permitted where those
        consignments are accompanied either by an animal health certificate, issued by the
        competent authority of the third country or territory, or by declarations or other
        documents, or by all of those documents. This Regulation should, therefore, clarify
        which documents are required in each case and should make it the responsibility of the
        competent authority to verify that such consignments entering the Union comply with
        that general requirement.
   (22) The information to be contained in the animal health certificates, declarations and
        other documents accompanying consignments of animals, germinal products and
        products of animal origin must accurately reflect whether or not those consignments
        comply with the general requirements provided for in the ‘Animal Health Law’ and
        the relevant requirements laid down in this Regulation. This Regulation should,
        therefore, lay down the obligations for operators responsible for entry into the Union
        of such consignments and for the competent authorities of the Member State of entry
        into the Union, as regards the validity of the documents accompanying the
        consignments and the eligibility of such consignments to enter the Union.
   (23) Taking into account animal health risks such as incubation periods for diseases, and in
        order to avoid the misuse of animal health certificates, it is necessary to establish a
        time limit for the validity of those certificates only in the case of animals and hatching
        eggs. This is because these pose a higher animal health risk than products of animal
        origin, which may have undergone risk-mitigating measures, and germinal products
        which are transported frozen in closed and sealed containers. However, as the
        transport by sea of live animals and hatching eggs may take long time, the validity
        period of the certificate in this case should be extended provided that certain risk-
        mitigating measures have been taken.
   (24) The animal health requirements that need to be complied with, and the guarantees to
        be provided by third countries and territories, for entry into the Union of consignments
        of animals, germinal products and products of animal origin depend on the diseases
EN                                                7                                                EN
 ---pagebreak---         listed in Article 5 and in Annex II to the ‘Animal Health Law’ and their categorisation
        as provided for in Article 9(1) of that Regulation and in the Annex to Commission
        Implementing Regulation (EU) 2018/18824. That Regulation lays down the definitions
        of category A, B, C, D and E diseases and states that the disease prevention and
        control rules for the listed diseases referred to in Article 9(1) of Regulation (EU)
        2016/429 are to be applied to listed species and groups of listed species referred to in
        its Annex.
   (25) Chapter 1 of Part II of the ‘Animal Health Law’ lays down the rules on disease
        notification and reporting to ensure early detection and effective disease control in the
        Union. This Regulation should specify the details on the notification and reporting
        systems to be in place in the third countries or territories to guarantee equivalent
        systems to those implemented in the Union, including the diseases that should be
        notifiable and reportable. In this sense, while live animals can transmit the diseases for
        which they are a listed species in Commission Implementing Regulation (EU)
        2018/1882, not all products of animal origin and germinal products obtained from
        those animals can transmit all those diseases. This Regulation should clarify which are
        the animal diseases of concern and therefore notifiable and reportable for each
        particular species and category of animals, germinal products and products of animal
        origin intended for entry into the Union.
   (26) The animal health requirements laid down in this Regulation should be based on
        different levels of protection from the animal health risks. The different requirements
        vary depending on whether they relate to a third country of origin, to a territory of
        origin, to a zone within that third country or territory, to a compartment within that
        third country or territory in the case of aquaculture animals, to the establishment of
        origin of the animals or the products of animal origin, or to the establishment or centre
        for collection of germinal products.
   (27) Disease surveillance and traceability in the establishments are key elements of the
        disease control policy in the Union. This Regulation should include certain basic
        requirements on traceability and animal health visits in the establishments of origin of
        the animals intended for entry into the Union, and in the establishment of origin of the
        animals from which the germinal products and products of animal origin intended for
        entry into the Union were obtained. These requirements should be equivalent to those
        laid down in Regulation (EU) 2016/429, and in delegated and implementing acts
        adopted pursuant to that Regulation.
   (28) Furthermore, where a certain type of establishment keeping animals or germinal
        products in a third country or territory poses a particular animal health risk, it should
        obtain specific approval by the competent authority in the third country or territory in
        order to export to the Union, providing equivalent guarantees as those provided in
        Articles 92 to 100 of Regulation (EU) 2016/429 for certain establishments in the
        Union.
   (29) Consignments of animals, germinal products and products of animal origin intended
        for entry into the Union should not be considered as representing an animal health risk
        in their country or territory of origin and should not be subject to national eradication
        programmes or any other national restrictions based on animal health concerns.
   4
        Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of
        certain disease prevention and control rules to categories of listed diseases and establishing a list of
        species and groups of species posing a considerable risk for the spread of those listed diseases.
EN                                                    8                                                          EN
 ---pagebreak---    (30) The animal health requirements for entry into the Union of consignments of animals,
        germinal products and products of animal origin must provide effective protection
        against the introduction and spread of transmissible animal diseases in the Union. The
        entry into the Union of those consignments should not be permitted from third
        countries or territories or zones or in the case of aquaculture animals, compartments
        thereof, infected with certain listed diseases for which the Union has disease-free
        status, and which consequently present a serious risk for the health of animals within
        the Union.
   (31) It is for the Union to assess whether a third country, territory or zone or, in the case of
        aquaculture animals, compartment of origin is free from a specific disease. The
        Union’s assessment should be based on information related to disease surveillance
        provided by the competent authority of the third country or territory, and taking into
        account Union animal health rules as provided for in Part II of the ‘Animal Health
        Law’ and Commission Delegated Regulation (EU) 2019/… as regards rules for
        surveillance, eradication programmes, and disease-free status for certain listed and
        emerging diseases [C(2019)4056]5. Specific conditions for certain diseases and
        circumstances may be required as additional risk-mitigating measures.
   (32) The freedom from a particular disease of a third country or territory or zone thereof
        must be based on internationally recognised diagnostic tests and methods performed
        under the same standards and procedures as those applied within the Union.
   (33) It is necessary to ensure that the health status of animals, germinal products and
        products of animal origin intended for entry into the Union complies with the
        guarantees provided by the third country, territory or zone of origin. This Regulation
        should therefore provide for a minimum residency period for animals in the third
        country, territory, zone or establishment of origin, and a minimum period without
        contact with commodities of a lower health status, before being dispatched to the
        Union. The length of the minimum period of residency should take into account the
        incubation period of relevant diseases, and the intended destination and use of the
        animals, germinal products and products of animal origin.
   (34) In the case of dogs, cats and ferrets, the residency period is unnecessary as vaccination
        against rabies, the disease of greatest concern for those species, is required in all cases.
        Registered horses intended for competitions, races and equestrian cultural events
        should also be exempted from certain requirements as regards the residency period, if
        they comply with additional guarantees. This exemption is based on the expectation
        that such horses will have a high level of health.
   (35) The health status of animals, germinal products and products of animal origin intended
        for entry into the Union may be jeopardised during transport from the place of origin
        to the place of entry into the Union if they enter into contact with animals or products
        not complying with the same requirements or if they transit through third countries,
        territories or zones with a lower health status than the country or territory of origin or
        zone thereof. Therefore certain preventive measures should be applied in order to
        preserve their health status.
   (36) To ensure that only healthy animals are dispatched to the Union, animals in
        consignments should undergo an clinical inspection carried out by an official
   5
        Commission Delegated Regulation (EU) 2019/…as regards rules for surveillance, eradication
        programmes, and disease-free status for certain listed and emerging diseases [C(2019)4056].
EN                                                    9                                              EN
 ---pagebreak---         veterinarian before they are dispatched. The time frame for performing this inspection
        should be adapted for certain species and their inherent risk.
   (37) Terrestrial animals, hatching eggs and aquatic animals intended for entry into the
        Union should only be transported through, or unloaded in, third countries, territories or
        zones also listed for entry into the Union of the same species and categories of animals
        and hatching eggs. Those countries, territories or zones’ inclusion on the list indicates
        that they provide equivalent animal health guarantees as the third country or territory
        of origin or zone thereof.
   (38) The transport of terrestrial animals and hatching eggs by means of aircraft or vessel
        could encounter unforeseen events such as mechanical problems in the means of
        transport, strikes in airports and seaports or unforeseen delays. It is therefore
        appropriate to provide for derogations in those cases where guarantees can be given.
        This will allow the transport of the terrestrial animals and hatching eggs to the Union
        to continue, while ensuring the health status of those commodities and preventing
        additional animal health risks.
   (39) In the case of equine animals, as transhipments and stopovers in non-listed countries
        are part of the usual transport operations, they should be allowed under certain
        preventive measures.
   (40) Cleaning and disinfection of means of transport is a key activity to prevent the risk of
        spreading animal diseases. When transporting consignments of live animals destined
        for the Union, cleaning and disinfection of means of transport should be carried out
        immediately before the loading of the animals for their dispatch to the Union.
   (41) Assembly operations of animals in third countries or territories of origin may pose an
        additional risk to the health status of animals intended for entry into the Union, as a
        result of the animals mixing with and coming into contact with animals of different
        origins. Therefore, the number, duration of such operations and species allowed to
        undergo them should be limited to a minimum and to those species with reliable
        traceability systems.
   (42) In addition to general animal health requirements, it is necessary to provide specific
        requirements taking into account the animal health risks linked to the different species
        and categories of terrestrial animals falling within the scope of this Regulation.
   (43) Different species of ungulates, as defined in the ‘Animal Health Law’, are listed as
        susceptible species for different listed diseases in Commission Implementing
        Regulation (EU) 2018/1882. Listed diseases are also set out in different categories for
        different species of ungulates in the same Regulation. Therefore this Regulation
        should clearly establish the specific requirements and guarantees in relation to listed
        diseases for the different species and categories of ungulates.
   (44) To prevent the occurrence of category A diseases, from which the Union is considered
        free, the general requirement for the third country or territory of origin or zone thereof
        of ungulates should be an equivalent freedom from disease for a period of time that
        guarantees that the entry of animals from the third country, territory or zone does not
        jeopardise the Union’s disease freedom. For category B diseases, for which the Union
        has compulsory eradication programmes, this Regulation should provide for risk-
        mitigating measures where the third country or territory of origin is not completely
        free of such diseases.
   (45) Where consignments of ungulates are intended for entry into Member States which are
        officially disease-free, or which have an approved eradication programme for
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 ---pagebreak---         infectious bovine rhinotracheitis/infectious pustular vulvovaginitis, bovine viral
        diarrhoea or infection with Aujeszky’s disease virus, those consignments should
        comply with additional requirements to ensure that the animals do not jeopardise the
        health status of those specific Member States as regards those diseases.
   (46) Special rules as regards the third country or territory of origin and additional animal
        health requirements should apply where ungulates originate from a confined
        establishment and are intended for entry into a confined establishment in the Union.
        The special rules should take into account the specificity of those confined
        establishments and the specific conditions they comply with in order to be approved
        by the competent authority of the third country or territory of origin and by the
        competent authority of the Member States of destination.
   (47) The confined establishment of origin could be located in a third country or territory
        which is not listed for entry into the Union of the specific species of ungulates.
        However, the national legislation and the veterinary services of the third country or
        territory will need to have been assessed. In addition, the establishment of origin
        should comply with additional requirements as regards disease surveillance, veterinary
        supervision, record keeping and operations. To ensure that those guarantees can be
        provided, this Regulation should lay down specific conditions for the approval of
        those confined establishments by the competent authority in the third country or
        territory. A list of such confined establishments should be drawn up by the Member
        State of destination, following the favourable outcome of a risk assessment by the
        competent authority in that Member State of all relevant information provided by the
        establishment as regards the animal health risks involved.
   (48) Specific animal health requirements should apply for entry into the Union of poultry
        and captive birds to address the particular risks posed by the relevant listed diseases
        for those animals. These requirements should take account of the category, species and
        intended use of poultry and captive birds, and provide effective protection against the
        spread into the Union of diseases of concern from third countries or territories.
   (49) To facilitate the trade of consignments of small amounts of poultry, specific
        requirements and derogations should be established for consignments with less than 20
        heads of poultry other than ratites.
   (50) Taking into account the activities and animal health risks associated with captive
        birds, consignments of those animals should only be permitted to enter the Union if
        they come from establishments approved by the competent authorities in the third
        country or territory of origin of the captive birds or zone thereof. The captive birds
        should be quarantined upon their arrival in the Union in order to confirm the absence
        of any disease of concern.
   (51) In addition, where consignments of birds and hatching eggs are intended for Member
        States with status free from infection with Newcastle disease virus without
        vaccination, such consignments should comply with additional requirements to ensure
        that those consignments do not jeopardise the health status for that disease of those
        specific Member States.
   (52) The infestation with the small hive beetle (Aethina tumida) is one of the diseases of
        most concern for bees. It is largely exotic to the Union but has spread globally in
        recent decades, creating serious problems for the apiculture industry and potentially
        also affecting bumble bees. Tropilaelaps mites (Tropilaelaps spp.) are potentially
        devastating pathogens of honeybees. They are also exotic to the Union. Effective and
EN                                             11                                               EN
 ---pagebreak---         safe treatments against these diseases are at present not available. If these diseases
        entered the Union by entering consignments, they would pose a risk to the
        sustainability of the apiculture sector and beyond, potentially affecting agriculture and
        the environment which benefits from pollination services by kept and wild bees.
   (53) American foulbrood occasionally occurs in the Union but is controlled with regard to
        trade of honeybees, while certain areas in the Union have been recognised as free of
        Varroa mites and protected by additional trade guarantees to keep places of
        destination in the Union safe. Rules at Union level have been and remain essential to
        mitigate the risk of entry into the Union of the above pathogens as associated with
        consignments of honeybees and bumble bees. Therefore such rules should be laid
        down in this Regulation.
   (54) Only queen honeybees without a brood and accompanied by a small number of
        attendants in single queen cages can be easily checked for infestation with small hive
        beetle or with Tropilaelaps mites, therefore the entry into the Union of honeybees
        should be limited to such consignments.
   (55) Colonies of bumble bees bred and reared in environmentally isolated establishments
        are often traded for the horticultural industry. Given the commonly used facilities,
        procedures and closed containers used for the shipped colonies, the entry into the
        Union of bumble bees (Bombus spp.) should be permitted only for colonies that are
        bred, reared and packaged solely under environmentally controlled conditions in
        establishments and which can be checked to ensure that they are free of the small hive
        beetle.
   (56) Because of its potential effects on humans and animals, rabies is the listed disease of
        most concern in the Union affecting dogs, cats and ferrets. Member States are
        therefore required to carry out a compulsory eradication programme against rabies
        infection in accordance with Commission Delegated Regulation (EU) 2019/… as
        regards rules for surveillance, eradication programmes, and disease-free status for
        certain listed and emerging diseases [document C(2019)4056]. To prevent any
        possibility of rabies being introduced into the Union, vaccination should be required
        for all consignments of dogs, cats and ferrets entering it, taking into account the
        availability and effectiveness of existing vaccines against the disease.
   (57) Dogs intended for entry into a Member State with disease-free status or with an
        approved eradication programme for Echinococcus multilocularis should comply with
        additional requirements to ensure the protection of that status in those Member States.
        In this regard, a preventive treatment should be applied to such dogs before they enter
        the Union. However, where dogs, cats and ferrets are intended for a confined
        establishment in the Union, special rules as regards rabies and infestation with
        Echinococcus multilocularis and additional animal health requirements should apply,
        taking into account the specificity of such establishments’ activities and the specific
        conditions under which animals are kept in them.
   (58) Germinal products may pose a significant risk for the spread of animal diseases. This
        is particularly true for semen, but also to a less extent to oocytes and embryos. As
        germinal products are collected or produced from a limited number of donors but used
        widely in the general animal population they can, if not handled properly or not
        classified with the correct health status, be a source of diseases for many animals.
        Such cases have occurred in the past and have caused substantial economic losses.
        Therefore, animal health requirements need to be put in place for entry into the Union
        of germinal products of certain kept terrestrial animals.
EN                                               12                                               EN
 ---pagebreak---    (59) The requirements for entry into the Union of germinal products of ungulates should be
        based on the requirements for entry into the Union of live animals.
   (60) Specific requirements for germinal product establishments where germinal products of
        ungulates eligible for entry into the Union are collected, produced, processed and
        stored should reflect those established for the movements within the Union. The same
        approach applies to the traceability and animal health requirements for germinal
        products.
   (61) Due to the need to move germinal products from confined establishments located in
        third countries to confined establishments located in the Union, this Regulation should
        lay down special traceability and animal health requirements for such entry.
   (62) Animal health requirements for entry into the Union of hatching eggs should address
        the risks as regards listed diseases that the different categories of hatching eggs could
        introduce into the Union. Therefore such requirements should correspond to those for
        entry into the Union of the respective species or categories of birds.
   (63) Where hatching eggs of poultry are intended for entry into Member States with status-
        free from infection with Newcastle disease virus without vaccination, the eggs should
        comply with additional requirements to ensure that they do not jeopardise the status of
        those specific Member States.
   (64) Products of animal origin can transmit disease agents to animals and products. The
        animal health risk linked to fresh and raw products of animal origin is obviously
        higher that those that have been processed and treated. Therefore the animal health
        requirements for the third country or territory of origin of fresh meat, raw milk,
        colostrum and colostrum-based products should be stricter than those for meat
        products and dairy products. However, the treatment applied to those treated products
        needs to be effective in order to mitigate the risk they pose depending on the species of
        origin of the product and the country or territory of origin.
   (65) The risk-mitigating treatments applicable for products of animal origin originating in
        restricted zones established in the event of confirmation of category A diseases in the
        Union are laid down in Commission Delegated Regulation (EU) 2019/XXX
        [document C(2019)4057]6, based on the available scientific knowledge and experience
        gained in the application of previous legislation. Therefore, the same risk-mitigating
        treatments should apply to those products originating in third countries, territories or
        zones thereof posing an equivalent animal health risk.
   (66) The risks linked to fresh meat entering the Union should be mitigated by requirements
        on the freedom from diseases of the third country or territory of origin and by
        requirements on animal diseases for the live animals from which the meat is obtained,
        on the dispatch of the kept animals to slaughter, on slaughter and killing operations,
        and on handling and preparation operations.
   (67) Fresh meat of terrestrial animals can be obtained from kept animals, including farmed
        game as defined in Regulation (EC) No 853/2004, and from wild animals. However, in
        the Union, meat obtained from animals kept as production animals, particularly,
        animals belonging to the species Bos taurus, Capra hirchus, Ovis aries and Sus scrofa,
        must be obtained in a slaughterhouse. To provide adequate and equivalent guarantees,
        it is therefore appropriate to exclude those species from the possibility to be
   6
        Commission Delegated Regulation (EU) 2019/xxx of the European Parliament and the Council as
        regards rules for the prevention and control of certain diseases [document C(2019)4057]
EN                                                     13                                           EN
 ---pagebreak---         categorised as farmed game or wild animals when fresh meat intended for entry into
        the Union originates from them.
   (68) When an outbreak of a relevant animal disease occurs in a third country or territory,
        the date and location of slaughter of kept animals or the date of killing of wild animals
        or farmed game are key to establishing the possible animal health risks associated with
        those animals and products of animal origin obtained from them. Therefore, the date
        of slaughter or killing needs to be established, in order to verify that the animals have
        been slaughtered or killed in a period of time without outbreaks of disease and when
        the third country or territory was listed as being authorised to enter fresh meat into the
        Union.
   (69) The type of treatment to be applied to products of animal origin should be in line with
        the risk posed by the third country or territory or zone thereof manufacturing the
        product. Entry into the Union of processed products of animal origin which have
        undergone treatments whose effectiveness in eliminating the risks linked to the listed
        diseases of concern for the particular category of product of animal origin has not been
        proven, should only be authorised from third countries or territories or zones thereof
        that provide all guarantees of freedom from the relevant diseases. For third countries
        or territories or zones thereof that do not provide all those guarantees, the entry into
        the Union of products of animal origin should be permitted only if those products have
        undergone a specific treatment.
   (70) In some cases, a third country or territory or zone thereof will source raw meat to
        produce meat products from a third country or territory or zone thereof listed for entry
        into the Union of meat products of the relevant species subject to a specific treatment.
        In such cases, the meat product should always undergo the most severe specific
        treatment in order to mitigate all possible animal health risks.
   (71) Meat products containing poultry meat from a third country or territory or zone thereof
        where there has been an outbreak of highly pathogenic avian influenza or infection
        with Newcastle disease virus should undergo a treatment that is effective at mitigating
        the risk in the third country or territory or zone thereof listed for entry into the Union.
        In this way, trade can be allowed to continue before measures for control such as
        regionalisation are implemented. The immediate application of a risk-mitigating
        treatment after an outbreak decreases the animal health risks and at the same time
        reduces the impact on trade.
   (72) When meat products are manufactured from fresh meat from different species the
        treatment applied should eliminate any possible animal health risks. Therefore, if the
        treatment is applied before mixing, the different types of fresh meat should receive the
        relevant treatment assigned to the species of origin of the fresh meat. However, if the
        treatment is applied after mixing, the final meat product should undergo the treatment
        assigned to the fresh meat ingredient with the highest animal health risk.
   (73) Treatments to mitigate specific animal health risks linked to the entry of casings
        should be reviewed and updated taking into account the conclusions and
        recommendations of the latest scientific evidence assessed by the European Food
        Safety Authority (EFSA) Panel on Animal Health and Welfare7.
   7
        EFSA Panel on Animal Health and Welfare (AHAW); Scientific Opinion on animal health risk
        mitigation treatments as regards imports of animal casings. EFSA Journal 2012; 10(7):2820. [32pp.]
        doi:10.2903/j.efsa.2012.2820. Available online: www.efsa .europa.eu/efsajournal
EN                                                   14                                                    EN
 ---pagebreak---    (74) The conditions for entry into the Union of raw milk, dairy products, colostrum and
        colostrum-based products are based on the animal health risks represented by these
        products. Such risks are linked to the country or territory of origin or zone thereof and
        to the species of animals from which they were obtained. Foot and mouth disease and
        infection with rinderpest virus are the two diseases of concern in the case of milk and
        colostrum, therefore raw milk and colostrum should only enter from third countries or
        territories or zones thereof which are free from those diseases. Colostrum-based
        products should also only originate from those third countries, territories or zones as
        there are no scientific-based risk-mitigating treatments to ensure the destruction of the
        disease agent in that category of products.
   (75) For milk obtained from Bos taurus, Ovis aries, Capra hircus, Bubalus bubalis and
        Camelus dromedarius, the risk related to foot and mouth disease can be mitigated with
        the application of well-known specific risk-mitigating treatments. However, as the
        effectiveness of certain of those treatments for dairy products from animal species
        other than Bos taurus, Ovis aries, Capra hircus, Bubalus bubalis and Camelus
        dromedarius cannot be ensured, they should undergo the most severe risk-mitigating
        treatment.
   (76) Treatments for products of animal origin should always be carried out in the third
        country or territory of origin or zone thereof listed for entry of those products into the
        Union.
   (77) Aquatic animals of listed species are sometimes transported by sea in vessels,
        including well-boats which may exchange water during the journey. In such cases, in
        addition to a health certificate, the animals should also be accompanied by a
        declaration signed by the master of the vessel outlining details of the ports of origin
        and destination and of any other ports visited during the journey. This declaration
        should confirm that the animals of listed species on board the vessel have not been
        exposed to any conditions that could have altered their health status during the journey
        to their final destination.
   (78) Aquatic animals may enter the Union for many different purposes. Given the disease
        risk associated with the movement of live animals, such animals entering the Union
        for human consumption should be treated in the same way as if they were entering the
        Union for other purposes such as farming or release into the wild. Products of animal
        origin from aquatic animals other than live aquatic animals represent a lower risk than
        aquatic animals, and the measures to be taken in relation to such products entering the
        Union for further processing, are therefore, less rigorous than those which apply to
        live animals.
   (79) Releasing aquatic animals into the wild in natural waters is a high-risk activity if those
        animals are infected with a listed disease. For that reason, for category A and B
        diseases specifically, the third country or territory of origin or zone or compartment
        thereof should be free of those diseases when aquatic animals are intended for release
        into the wild in natural waters of the Union. In addition, aquatic animals brought into
        the Union to be released into the wild in natural waters should in all cases, originate
        from a third country or territory or zone or compartment declared free of a category C
        disease even when the Member State or zone or compartment of destination is not free
        from that disease.
   (80) In the case of aquatic diseases, Member States may take national measures under
        Article 226 of the ‘Animal Health Law’ designed to limit the impact of diseases other
        than listed diseases, within their own territory. In such cases, consignments of species
EN                                              15                                                 EN
 ---pagebreak---         susceptible to the diseases to which those national measures apply will also need to
        originate from third countries, territories, zones or compartments thereof, which are
        free of those diseases.
   (81) Article 226 of the ‘Animal Health Law’ reflects the same intent as Article 43 of
        Directive 2006/88/EC as it allows Member States to take national measures against
        diseases which are not listed. It is therefore appropriate, to continue to recognise the
        list of diseases and the relevant species for which those measures have been put in
        place. These details should be set out in this Regulation.
   (82) Certain rules apply within the Union in relation to the registration and approval of
        aquaculture establishments. The differentiation between whether an establishment can
        be registered or whether it should be approved depends upon the risk it presents of
        contracting or spreading disease. It is important therefore, that aquaculture animals
        which enter the Union from aquaculture establishments in a third country, territory,
        zone or compartment thereof, should originate from aquaculture establishments which
        are assessed in a similar way. In that context, such establishments should comply with
        registration or approval requirements which are at least as stringent as those laid down
        for such establishments within the Union.
   (83) It is not mandatory in all situations to apply the requirement that aquatic animals of
        listed species and products of animal origin from those animals originate from a third
        country or territory or zone or compartment thereof free from disease. Certain risk-
        mitigation measures can be taken to facilitate the entry into the Union of aquatic
        animals and certain products of animal origin thereof which do not have such an
        origin. Certain risk-mitigation measures are acceptable for aquatic animals of listed
        species and given the lower level of risk associated with such movements, different,
        less stringent risk-mitigation measures are acceptable for products of animal origin
        from aquatic animals other than live aquatic animals.
   (84) The mitigation measures that apply to aquatic animals include their being consigned to
        a disease control aquatic food establishment, a confined establishment or an approved
        quarantine establishment after entry into the Union. A number of other risk-mitigating
        measures apply to molluscs and crustaceans of listed species which enter the Union
        alive and in compliance with Regulation (EU) No 853/2004 but which represent an
        acceptable risk because of how they were treated or packaged before dispatch or
        because they are not intended for storage in the Union, prior to processing.
   (85) It is possible to derogate from the requirements that certain products of animal origin
        from aquatic animals other than live aquatic animals, have to originate in a third
        country or territory or zone or compartment thereof which is free from the relevant
        listed diseases. The risk-mitigation measures allowing such trade to occur may consist
        of consigning the products of animal origin to a disease control aquatic food
        establishment in the Union for further processing, or of ensuring that the products of
        animal origin consist of fish which were slaughtered and eviscerated before being
        dispatch to the Union. In either case, the risk posed by the products of animal origin is
        assessed as negligible.
   (86) Commission Implementing Regulation (EU) 2018/1882 establishes a list of aquatic
        species and groups of species that pose a considerable risk for the spread of the
        diseases listed in Article 5 and Annex II to the ‘Animal Health Law’. The list also
        includes a list of vector species, which is set out in column 4 of the table in the Annex
        to that Regulation. Many of those species do not, however, act as vectors in all
        circumstances. In relation to movements, details of the circumstances in which those
EN                                              16                                                EN
 ---pagebreak---         species are considered to be vectors of the listed diseases are set out in Annex XXX to
        this Regulation. In circumstances where aquatic animals of listed species do not fulfil
        the conditions to be vectors, they are not covered by the rules set out in this
        Regulation. In addition, given the lower level of risk posed by products of animal
        origin from aquatic animals other than live aquatic animals, the measures set out in
        this Regulation in relation to these products do not apply to the species listed in
        column 4 of the table in the Annex to Commission Implementing Regulation (EU)
        2018/1882.
   (87) All derogations and handling requirements provided for in this Regulation in relation
        to aquatic animals of listed species and to products of animal origin from those listed
        species other than live aquatic animals, should also apply to the species listed in
        column 4 of the table in the Annex to Commission Implementing Regulation (EU)
        2018/1882 for which Member States have taken national measures under Article 226
        of the ‘Animal Health Law’. Likewise, these derogations and handling requirements
        should also apply to certain susceptible species.
   (88) It is important that aquatic animals of listed species, and the water in which they are
        transported, are handled appropriately after entry into the Union to ensure that they do
        not pose a disease risk. Appropriate handling includes ensuring that the animals are
        transported directly to the place of destination and are not released or otherwise
        immersed in natural waters of the Union, where they could cause a potential disease
        risk.
   (89) In certain cases, however, the competent authority at the place of destination may
        allow authorisation for such animals to be released into natural waters. In all such
        cases, it should be for the competent authority to ensure that the release or immersion
        does not jeopardise the health status at the place of release. Furthermore, even if the
        receiving waters are not free of a specific category C disease, the animals to be
        released should be disease-free, in order to ensure the best overall health status is
        achieved for wild populations in natural waters of the Union.
   (90) In relation to the animal health risk involved, all transit movements through the Union
        should be considered as movements for entry into the Union as they imply the same
        level of risk. Transit movements should therefore comply with all the relevant
        requirements for entry into the Union. However, derogations and special rules for
        transit should be established under specific risk-mitigating conditions linked to the
        place of origin. Such derogations and special rules are intended to cover situations
        where the Union is not the final destination for the animals and products thereof and to
        take into account geographical constraints and geopolitical factors.
   (91) Derogations and special rules should also be established for the transit of
        consignments of animals and products thereof via a third country or territory between
        Member States. This is to cover situations where such type of entry into the Union is
        required by a Member State.
   (92) In some cases commodities originating in the Union are refused by the competent
        authorities of a third country or territory following controls carried out at their border.
        Special rules should be adopted under Article 239 of the ‘Animal Health Law’ to
        allow the return of those commodities on the grounds that they have been produced
        under the Union’s animal health legislation.
EN                                               17                                                 EN
 ---pagebreak---    (93) Special rules are also necessary for the return to the Union of registered horses after
        temporary export to third countries in order to participate in races, competitions and
        equestrian cultural events.
   (94) With a view to the uniform application of Union legislation on entry into the Union of
        animals, germinal products and products of animal origin and to ensure that the
        legislation is clear and transparent, this Regulation should repeal Commission
        Regulation (EU) No 206/20108, Commission Implementing Regulation (EU)
        139/20139, Commission Regulation (EU) No 605/201010, Commission Regulation
        (EC) No 798/200811, Commission Decision 2007/777/EC12, Commission Regulation
        (EC) No 119/200913, Commission Regulation (EU) No 28/201214 and Commission
        Implementing Regulation (EU) 2016/75915.
   (95) The rules contained in this regulation are linked and complement those of the ‘Animal
        Health Law’ that applies from 21 April 2021. For this reason and to facilitate the
        application of the new animal health legal framework this Regulation should also
        apply from 21 April 2021,
   HAS ADOPTED THIS REGULATION:
                                                    PART I
                                              General rules
                                                    TITLE 1
                      SUBJECT MATTER, SCOPE AND DEFINITIONS
   8
        Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries,
        territories or parts thereof authorised for the introduction into the European Union of certain animals
        and fresh meat and the veterinary certification requirements (OJ L 73, 20.3.2010, p.1)
   9
        Commission Implementing regulation (EU) No 139/2013 of 7 January 2013 laying down animal health
        conditions for imports of certain birds into the Union and the quarantine conditions thereof (OJ L 47,
        20.2.2013, p.1)
   10
        Commission Regulation (EU) No 605/2010 of 2 July 2010 laying down animal and public health and
        veterinary certification conditions for the introduction into the European Union of raw milk and dairy
        products intended for human consumption (OJ L 175, 10.7.2010, p.1)
   11
        Commission regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries,
        territories, zones or compartments from which poultry and poultry products may be imported into and
        transit through the Community and the veterinary certification requirements (OJ L 100, 14.4.2011, p.1)
   12
        Commission Decision 2007/777/EC of 29 November 2007 laying down the animal and public health
        conditions and model certificates for imports of certain meat products and treated stomachs, bladders
        and intestines for human consumption from third countries and repealing Decision 2005/432/EC (OJ L
        312, 30.11.2007, p.49)
   13
        Commission Regulation (EC) No 119/2009 of 9 February 2009laying down a list of third countries or
        parts thereof, for imports into, or transit through, the Community of meat of wild leporidae, of certain
        wild land mammals and of farmed rabbits and the veterinary certification requirements (OJ L 39,
        10.2.2009, p.12)
   14
        Commission Regulation (EU) No 28/2012 of 11 January 2012 laying down requirements for the
        certification for imports into and transit through the Union of certain composite products and amending
        Decision 2007/275/EC and Regulation (EC) No 1162/2009 (OJ L 12, 14.1.2012, p.1)
   15
        Commission Implementing Regulation (EU) 2016/759 of 28 April 2016 drawing up lists of third
        countries, parts of third countries and territories from which Member States are to authorise the
        introduction into the Union of certain products of animal origin intended for human consumption,
        laying down certificate requirements, amending Regulation (EC) No 2074/2005 and repealing Decision
        2003/812/EC (OJ L 126, 14.5.2016, p.13)
EN                                                       18                                                      EN
 ---pagebreak---                                            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:
EN                                             19                                            EN
 ---pagebreak---             (a)    kept and wild ungulates of listed species;
            (b)    poultry;
            (c)    game birds.
   6.       Part V lays down the animal health requirements for 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, other than wild aquatic animals and products of animal origin from
            those wild aquatic animals landed from fishing vessels for direct human
            consumption:
            (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.
   8.       Part VII lays down final provisions.
                                                Article 2
                                               Definitions
   For the purposes of this Regulation, the definitions laid down in Commission Implementing
   Regulation (EU) 2018/1882 and Annex I to Regulation (EC) 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;
EN                                                 20                                                  EN
 ---pagebreak---    (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;
   (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;
   (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;
EN                                              21                                                EN
 ---pagebreak---    (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
EN                                             22                                               EN
 ---pagebreak---           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;
   (48)   ‘well-boat’ means a vessel used by the aquaculture industry which has a well or tank
          for the storage and transport of live fish in water;
   (49)   ‘IMSOC’ means the information management system for official controls provided
          for in Article 131 of Regulation (EU) No 2017/625.
                                              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
EN                                                23                                               EN
 ---pagebreak---                                                 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:
           (i)    in the case of terrestrial animals, a listed third country or territory or zone
                  thereof for the particular species and category of animals, germinal products
                  and products of animal origin;
           (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
EN                                                 24                                                 EN
 ---pagebreak---            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
EN                                                 25                                               EN
 ---pagebreak---                   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:
EN                                                 26                                                EN
 ---pagebreak---             (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.
EN                                                   27                                              EN
 ---pagebreak---            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 Commission Delegated
                 Regulation (EU) 2019/… as regards rules for surveillance, eradication
                 programmes, and disease-free status for certain listed and emerging diseases
                 [document C(2019)4056] and Commission Delegated Regulation (EU) 2019/…
                 as regards animal health requirements for movements within the Union of
                 terrestrial animals and hatching eggs [document C(2019)4058];
           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) 2019/… as regards the
                 approval of germinal product establishments and the traceability and animal
                 health requirements for movements within the Union of germinal products of
                 certain kept terrestrial animals [document C(2019)4055];
           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 Commission Delegated Regulation (EU) 2019/… as regards
                 rules for surveillance, eradication programmes, and disease-free status for
                 certain listed and emerging diseases [document C(2019)4056];
EN                                                28                                               EN
 ---pagebreak---         or
        (b)   for diseases not falling within the scope of Commission Delegated Regulation
              (EU) 2019/… as regards rules for surveillance, eradication programmes, and
              disease-free status for certain listed and emerging diseases [document
              C(2019)4056], 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 Commission
                            Delegated Regulation (EU) 2019/… as regards rules for
                            surveillance, eradication programmes, and disease-free status for
                            certain listed and emerging diseases [document C(2019)4056].
              (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
EN                                               29                                              EN
 ---pagebreak---                                               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.
EN                                                 30                                                EN
 ---pagebreak---    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.
      In the case of poultry and captive birds, that inspection shall cover both the animals
      intended for dispatch to the Union and the flock of origin.
   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.
EN                                            31                                               EN
 ---pagebreak---                                                 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:
EN                                                  32                                                EN
 ---pagebreak---             (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 quick 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
EN                                                  33                                                 EN
 ---pagebreak---                    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:
EN                                                  34                                              EN
 ---pagebreak---          (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) 2019/166616.
   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) 2019/203517;
   16
       Commission Delegated Regulation (EU) 2019/1666 of 24 June 2019 supplementing Regulation (EU)
       2017/625 of European Parliament and the Council as regards conditions for monitoring the transport
       and arrival of consignments of certain goods from the border control post of arrival to the establishment
       at the place of destination in the Union (OJ L 255, 4.10.2019, p.1)
   17
       Commission Delegated Regulation (EU) 2019/2035 of 28 June 2019 supplementing Regulation (EU)
       2016/429 of the European Parliament and of the Council as regards rules for establishments keeping
EN                                                    35                                                         EN
 ---pagebreak---                  (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 Commission 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;
      terrestrial animals and hatcheries, and the traceability of certain kept terrestrial animals and hatching
      eggs (OJ L 314, 5.12.2019, p.115)
EN                                                   36                                                         EN
 ---pagebreak---              (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.
EN                                             37                                                 EN
 ---pagebreak---    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
EN                                            38                                                EN
 ---pagebreak---             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
EN                                            39                                              EN
 ---pagebreak---             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.
                                                Article 26
                 Movement and handling of ungulates after their entry into the Union
   Following their entry into the Union, ungulates, except horses entering for competition, races
   and cultural equestrian events, shall remain in their establishment of destination for a period
   of time of at least 30 days since their arrival to that establishment.
                                              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:
EN                                                   40                                            EN
 ---pagebreak---             (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.
EN                                                  41                                               EN
 ---pagebreak---    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
EN                                                    42                                             EN
 ---pagebreak---                  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.
EN                                                 43                                                EN
 ---pagebreak---                                                  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 .
EN                                                   44                                               EN
 ---pagebreak---                                               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.
EN                                                45                                                  EN
 ---pagebreak---                                               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
EN                                                 46                                               EN
 ---pagebreak---        (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;
EN                                             47                                                  EN
 ---pagebreak---            (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
EN                                                  48                                               EN
 ---pagebreak---       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 Commission 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 Commission
            Delegated Regulation (EU) 2019/2035; and
            (i)    the approval of which has not been suspended or withdrawn;
EN                                           49                                               EN
 ---pagebreak---                    (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 Commission 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;
EN                                                   50                                                 EN
 ---pagebreak---             (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).
EN                                           51                                                EN
 ---pagebreak---                                                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 Commission 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)), Salmonela Pullorum, Salmonella
                    Gallinarum, Mycoplasma meleagridis and Mycoplasma gallisepticum in case
                    of Meleagris gallopavo;
EN                                                   52                                               EN
 ---pagebreak---             (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:
EN                                                   53                                                EN
 ---pagebreak---             (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 Commission Delegated Regulation (EU)
EN                                                   54                                                EN
 ---pagebreak---             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:
EN                                                   55                                                EN
 ---pagebreak---    (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
   By way of derogation from Article 14(3), Article 17, Article 18, Article 40 and Article 41 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:
   (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 km radius of the establishment, 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 for a
                  period of at least 30 days prior to date of loading of the consignment for
                  dispatch to the Union;
   (b)      the poultry or, in the case of day-old chicks, the flock of origin of the day-old chicks,
            have been isolated on the establishment of origin for a period of at least 21 days prior
            to the date of loading of the consignment for dispatch to the Union;
   (c)      as regards vaccination against highly pathogenic avian influenza:
            (i)   the poultry not been vaccinated against highly pathogenic avian influenza;
            (ii)  where the parent flocks of the day-old chicks 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;
EN                                                 56                                                 EN
 ---pagebreak---    (d)      where the poultry or the parent flock of the day-old chicks 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 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;
   (e)      the poultry or, in the case of day-old chicks the flock of origin of the day-old chicks,
            were found not to be infected or showed any grounds for suspecting any infection by
            the following agents in tests performed in accordance with the requirements for
            testing of consignments of less than 20 heads of poultry other than ratites and less
            than 20 hatching eggs thereof prior to the entry into the union, set out in Annex
            XVII;
            (i)   Salmonella Pullorum, Salmonella Gallinarum and Mycoplasma gallisepticum
                  in case of Gallus gallus;
            (ii)  Salmonella arizonae (serogroup O:18(k)), Salmonela 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.
                                              SECTION 6
      SPECIFIC ANIMAL HEALTH REQUIREMENTS FOR MOVEMENT
        AND HANDLING OF POULTRY AFTER THE ENTRY INTO THE
                                                UNION
                                                Article 50
       Obligations on operators at the establishment of destination following the entry into the
                                   Union of consignments of poultry
   1.       Operators at the establishment of destination shall keep breeding poultry, productive
            poultry, except productive poultry for restocking supplies of game birds, and day-old
            chicks which have entered into the Union from a third country or territory or zone
            thereof on the establishments of destination from their date of arrival for a
            continuous period of at least:
            (a)   6 weeks;
            or
EN                                                  57                                               EN
 ---pagebreak---             (b)     until the day of slaughter, when the animals are slaughtered within 6 weeks of
                    the date of arrival.
   2.       In the case of poultry other than ratites, the 6 week period provided for in paragraph
            1(a), may be reduced to 3 weeks, provided that, at the request of the operator,
            sampling and testing in accordance with Article 51(b) have been carried out with
            favourable results.
   3.       Operators at the establishment of destination shall ensure that poultry referred to in
            paragraph 1, undergo a clinical inspection carried out by an official veterinarian on
            the establishment of destination no later than the date of expiry of the relevant
            periods provided for in that paragraph.
   4.       During the periods provided for in paragraph 1, operators shall keep poultry which
            have entered into the Union from a third country or territory or zone thereof, separate
            from other flocks of poultry.
   5.       Where poultry referred to in paragraph 1 are placed in the same flock as other poultry
            present at the establishment of destination, the periods referred to in paragraph 1(a)
            and (b) shall commence from the date of introduction of the last bird on the
            establishment of destination and no poultry present shall be moved from the flock
            before the expiry of those periods.
                                                 Article 51
    Obligation on the competent authorities as regards sampling and testing of consignments of
                                     poultry after entry into the Union
   The competent authority of the Member State of destination shall ensure that:
   (a)      during the periods provided for in Article 50(1), breeding poultry, productive
            poultry, except productive poultry for restocking supplies of game birds, and day-old
            chicks which have entered into the Union from a third country or territory or zone
            thereof, undergo a clinical inspection carried out by an official veterinarian on the
            establishment of destination no later than the date of expiry of the relevant periods
            provided for in that Article and, where necessary, sampled for testing to monitor their
            health status;
   (b)      in the case of poultry other than ratites and when it is requested by the operator as
            referred to in Article 50(2), sampling and testing of poultry other than ratites is
            carried out in accordance with Annex XVIII.
                                                 Article 52
    Obligation on the competent authorities as regards sampling and testing following the entry
   into the Union of consignments of ratites originating from a third country or territory or zone
                       thereof not free from infection with Newcastle disease virus
   The competent authority of the Member State of destination shall ensure that breeding ratites,
   productive ratites and day-old chicks of ratites that have entered into the Union from a third
   country or territory or zone thereof that is not free from infection with Newcastle disease
   virus, during the periods provided for in Article 50(1):
   (a)      they are subject to a virus detection test for infection with Newcastle disease virus
            carried out by the competent authority on a cloacal swab or faeces sample from each
            ratite;
EN                                                   58                                             EN
 ---pagebreak---    (b) in the case of consignments of ratites destined for a Member States with status free
       from infection with Newcastle disease virus without vaccination from a third country
       or territory or zone thereof not free from infection with Newcastle disease virus, in
       addition to the requirements referred to in point (a), they are subject to a serological
       test for infection with Newcastle disease virus carried out by the competent authority
       on each ratite;
   (c) all ratites shall have tested negative to the tests provided for in points (a) and (b)
       prior to their release from isolation.
EN                                            59                                                EN
 ---pagebreak---                                               Chapter 2
             Specific animal health requirements for captive birds
                                              SECTION 1
           ANIMAL HEALTH REQUIREMENTS FOR CAPTIVE BIRDS
                                                Article 53
                     Requirements concerning the identification of captive birds
   Consignments of captive birds shall only be permitted to enter the Union if the animals of the
   consignment are identified with an individual identification number by means of a unique
   marked closed leg-ring or an injectable transponder, which contains at least the following
   information:
   (a)      the code of the third country or territory of origin conforming with ISO Standard
            3166 in the format of two-letter;
   (b)      a unique serial number.
                                                Article 54
        Specific preventive measures for the containers in which captive birds are transported
   Consignments of captive birds shall only be permitted to enter the Union if such
   consignments have been transported in containers which, in addition to the requirements
   regarding containers laid down in 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 the possibility of any substitution
            of the contents;
   (b)      they bear the information for the particular species and category of birds set out in
            Annex XVI;
   (c)      they are used for the first time.
                                                Article 55
       Requirements concerning the establishment of origin of the consignment of captive birds
   Consignments of captive birds shall only be permitted to enter the Union if the animals of the
   consignment come from an establishment which complies with the following requirements:
   (a)      it has been approved by the competent authority of the third country or territory of
            origin as meeting the specific animal requirements laid down in Article 56, and that
            approval has not been suspended or withdrawn;
   (b)      it has been assigned a unique approval number by the competent authority of the
            third country or territory of origin, which has been communicated to the
            Commission;
   (c)      the name and approval number of the establishment of origin appears on a list of
            establishments drawn up and published by the Commission;
   (d)      within a 10 km radius of the establishment, including, where appropriate, the
            territory of any neighbouring country, there has been no outbreak of highly
EN                                                  60                                                 EN
 ---pagebreak---             pathogenic avian influenza or infection with Newcastle disease virus for a period of
            at least the preceding 30 days prior to the date of loading for dispatch to the Union;
   (e)      in the case of psittacidae, either:
            (i)    avian chlamydiosis has not been confirmed on the establishment for a period
                   of at least the 60 days prior to the date of loading for dispatch to the Union and
                   in case avian chlamydiosis has been confirmed on the establishment during the
                   last 6 months prior to the date of loading for dispatch to the Union, the
                   following measures have been applied:
                   –      infected birds and birds likely to be infected have received treatment;
                   –      following the completion of the treatment, they have been found negative
                          to laboratory testing for avian chlamydiosis;
                   –      after the completion of the treatment, the establishment has been cleaned
                          and disinfected;
                   –      at least 60 days have elapsed from the completion of the cleaning and
                          disinfection referred to in the third indent;
            or
            (ii)   the animals have been kept under veterinary supervision for the 45 days prior
                   to the date of loading for dispatch to the Union and were treated against avian
                   chlamydiosis.
                                                  Article 56
         Specific animal health requirements for the approval, maintenance of approval and
     suspension, withdrawal or re-granting of the approval of the establishments of origin of the
                                       consignment of captive birds
   1.       Consignments of captive birds 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 as referred to in Article 55, and
            that comply with the following requirements set out in Annex XIX:
            (a)    point 1, in relation to biosecurity measures;
            (b)    point 2, in relation to facilities and equipment;
            (c)    point 3, in relation to record keeping;
            (d)    point 4, in relation to personnel;
            (e)    point 5, in relation to health status.
   2.       Consignments of captive birds shall only be permitted to enter into the Union if the
            animals of the consignment come from establishments which are under the control of
            an official veterinarian of the competent authority of the third country or territory,
            who shall:
            (a)    ensure that the conditions set out in this Article are met;
            (b)    visit the premises of the establishment at least once per year;
            (c)    audit the activity of the veterinarian of the establishment and the
                   implementation of the annual disease surveillance programme;
EN                                                    61                                              EN
 ---pagebreak---            (d)   verify that the results of the clinical, post-mortem and laboratory tests on the
                 animals have revealed no occurrence of highly pathogenic avian influenza,
                 infection with Newcastle disease virus or avian chlamydiosis.
   3.      The approval of an establishment of captive birds shall be suspended or withdrawn
           where that establishment no longer complies with the conditions set out in
           paragraphs 1 and 2, or there has been a change of use so that it is no longer used
           exclusively for captive birds.
   4.      The approval of an establishment of captive birds shall be suspended when the
           competent authority of the third country or territory has received notification of the
           suspicion of highly pathogenic avian influenza, infection with Newcastle disease
           virus or avian chlamydiosis, and until the suspicion has been officially ruled out.
           Following the notification of suspicion, the necessary measures to confirm or rule out
           the suspicion and to avoid any spread of disease shall be taken, in accordance with
           the requirements of Commission Delegated Regulation (EU) 2019/… supplementing
           Regulation (EU) 2016/429 of the European Parliament and the Council, as regards
           rules for the prevention and control of certain transmissible animal listed
           diseases[document C(2019)4057].
   5.      When the approval of an establishment has been suspended or withdrawn, the
           establishment shall again be approved provided the following conditions are met:
           (a)   the disease and the source of infection has been eradicated;
           (b)   adequate cleaning and disinfection has been carried out on previously infected
                 establishments;
           (c)   the establishment fulfils the conditions laid down in paragraph 1.
   6.      Consignments of captive birds shall only be permitted to enter into the Union when
           the third country or territory of origin has undertaken to inform the Commission of
           the suspension, withdrawal or re-granting of approval of any establishment.
                                              Article 57
                     Specific animal health requirements for the captive birds
   Consignments of captive birds shall only be permitted to enter the Union if the animals of the
   consignment:
   (a)     have not been vaccinated against highly pathogenic avian influenza;
   (b)     have been vaccinated against infection with Newcastle disease virus and the
           competent authority of the third country or territory of origin has provided
           guarantees that the vaccines used comply with the general and specific criteria for
           vaccines against infection with Newcastle disease virus set out in point 1 of Annex
           XV;
   (c)     have been subjected to a virus detection test for highly pathogenic avian influenza
           and Newcastle disease with negative results, within a period of 7 to 14 days prior to
           the date of loading for dispatch to the Union.
EN                                                62                                              EN
 ---pagebreak---                                                 Article 58
    Requirements concerning the entry of consignments of captive birds into Member States with
              status free from infection with Newcastle disease virus without vaccination
   Consignments of captive birds of galliformes species intended for a Member State with status
   free from infection with Newcastle disease virus without vaccination, shall only be permitted
   to enter the Union if the animals of the consignment:
   (a)       have not be vaccinated against infection with Newcastle disease virus;
   (b)       have been kept in isolation for 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 in the third country or territory of origin under the
             supervision of an official veterinarian, where:
             (i)   no bird has been vaccinated against infection with Newcastle disease virus
                   during the period of 21 days preceding the date of dispatch of the consignment;
             (ii)  no bird which was not intended for the consignment has entered into the
                   establishment during that time;
             (iii) no vaccination has been carried out on the establishment;
   (c)       have tested negative, during the period of 14 days prior to the date of loading for
             dispatch to the Union, to serological tests to detect the presence of antibodies against
             Newcastle disease virus, performed on blood samples at a level which gives 95 %
             confidence of detecting infection at 5% prevalence.
                                             SECTION 2
      SPECIFIC ANIMAL HEALTH REQUIREMENTS FOR MOVEMENT
      AND HANDLING OF CAPTIVE BIRDS AFTER THEIR ENTRY INTO
                                            THE UNION
                                                Article 59
          Requirements concerning the movement of captive birds after entry into the Union
   Following their entry into the Union, consignments of captive birds shall be transported
   without delay directly to a quarantine establishment approved in accordance with Article 14
   of Commission Delegated Regulation (EU) 2019/2035, as follows:
   (a)       the total journey from the point of entry into the Union to the quarantine
             establishment must not exceed 9 hours;
   (b)       vehicles used for the transport of the consignment to the quarantine establishment
             must be sealed by the competent authority in such a way that prevents the possibility
             of any substitution of the contents.
                                                Article 60
    Obligation on operators at the quarantine establishment following the entry into the Union of
                                      consignments of captive birds
   Operators of the quarantine establishment for the captive birds referred to in Article 59 shall:
   (a)       keep captive birds quarantined for a period of at least 30 days;
   (b)       where sentinel birds are used for examination, sampling and testing procedures,
             ensure that:
EN                                                  63                                                 EN
 ---pagebreak---              (i)   a minimum number of 10 sentinel birds are used in each unit of the quarantine
                   establishment;
             (ii)  they are at least 3 weeks old and used only once for those purposes;
             (iii) they are either leg-banded for identification purposes or identified with another
                   non-removable means of identification;
             (iv) they are unvaccinated and have been found sero-negative for highly pathogenic
                   avian influenza and infection with Newcastle disease virus within a period of
                   14 days prior to the date of commencement of quarantine;
             (v)   they are placed in the approved quarantine establishment before the arrival of
                   the captive birds in the common air space and as close as possible to the
                   captive birds so that close contact between the sentinel birds and the
                   excrements of the captive birds in quarantine is ensured;
             (vi) release the captive birds from quarantine only on the written authorisation of an
                   official veterinarian.
                                                Article 61
   Obligation on the competent authorities following the entry into the Union of consignments of
                                              captive birds
   Following the arrival of the captive birds in the quarantine establishment referred to in Article
   59, the competent authority shall:
   (a)       inspect the conditions of quarantine, including an examination of the mortality
             records and a clinical inspection of the captive birds, at least at the beginning and the
             end of quarantine period;
   (b)       subject the captive birds to testing for highly pathogenic avian influenza and
             infection with Newcastle disease virus, in accordance with the examination,
             sampling and testing procedures set out in Annex XX.
                                             SECTION 3
       DEROGATIONS FROM THE ANIMAL HEALTH REQUIREMENTS
         FOR ENTRY INTO THE UNION OF CAPTIVE BIRDS AND FOR
        MOVEMENT AND HANDLING OF THOSE BIRDS AFTER THEIR
                                   ENTRY INTO THE UNION
                                                Article 62
    Derogation from animal health requirements for captive birds originating from certain third
                                          countries or territories
   By way of derogation from requirements laid down in Articles 3 to 10 of Part I, except point
   (a)(i) of Article 3, Articles 11 to 19 and Articles 53 to 61, consignments of captive birds
   which do not comply with those requirements shall be permitted to enter the Union if they
   originate from third countries or territories specifically listed for the entry into the Union of
   captive birds based on equivalent guarantees.
EN                                                  64                                                 EN
 ---pagebreak---                                                TITLE 4
     ANIMAL HEALTH REQUIREMENTS FOR HONEYBEES AND
                                         BUMBLE BEES
                                              Chapter 1
     General animal health requirements for honeybees and bumble
                                                  bees
                                                Article 63
                                    Authorised categories of bees
   Only consignments of the following categories of bees shall be permitted to enter the Union:
   (a)      queen honeybees;
   (b)      bumble bees.
                                                Article 64
                         Dispatch to the Union of honeybees and bumble bees
   Consignments of queen honeybees and bumble bees shall only be permitted to enter the
   Union if they comply with the following requirements:
   (a)      the packaging material and queen cages used to dispatch the honeybees and bumble
            bees into the Union must:
            (i)   be new;
            (ii)  not have been in contact with any bees and brood combs;
            (iii) have been subject to all precautions to prevent their contamination with
                  pathogens causing diseases of honeybees or bumble bees.
   (b)      the feedingstuff accompanying the honeybees and bumble bees must be free from
            pathogens causing their diseases;
   (c)      the packaging material and accompanying products must have undergone a visual
            examination prior to dispatch to the Union to ensure that they do not pose an animal
            health risk and do not contain:
            (i)   in the case of honeybees, Aethina tumida (Small hive beetle) and Tropilaelaps
                  mite in any of their life stages;
            (ii)  in the case of bumble bees, Aethina tumida (Small hive beetle), in any of their
                  life stages.
                                              Chapter 2
          Specific animal health requirements for queen honeybees
                                                Article 65
                               The apiary of origin of queen honeybees
   Consignments of queen honeybees shall only be permitted to enter the Union if the honeybees
   of the consignment originate from an apiary which is situated in an area:
EN                                                  65                                            EN
 ---pagebreak---    (a)       of at least a 100 km radius, including where appropriate the territory of a
             neighbouring third country:
             (i)   where infestation with Aethina tumida (Small hive beetle) or infestation with
                   Tropilaelaps spp. has not been reported;
             (ii)  there are no restrictions in place due to a suspicion, case or outbreak of the
                   diseases referred to in (i).
   (b)       of at least 3 km radius, including where appropriate the territory of a neighbouring
             third country:
             (i)   American foulbrood has not been reported for a period of at least 30 days prior
                   to the date of loading for dispatch to the Union;
             (ii)  there are no restrictions in place due to a suspicion or a confirmed case of
                   American foulbrood during the period referred to in point (i);
             (iii) where there had been a previous confirmed case of American foulbrood before
                   the period referred to in point (i), all hives were subsequently checked by the
                   competent authority in the third country or territory of origin and all infected
                   hives were treated and subsequently inspected with favourable results within a
                   period of 30 days from the date of last recorded case of that disease.
                                                 Article 66
                                  The hive of origin of queen honeybees
   Consignments of queen honeybees shall only be permitted to enter the Union if the
   honeybees of the consignment originate from hives from which samples of the comb have
   been tested for American foulbrood with negative results within the period of 30 days prior to
   the date of loading for dispatch to the Union.
                                                 Article 67
                                  The consignment of queen honeybees
   Consignments of queen honeybees shall only be permitted to enter the Union if such
   consignments are in closed cages, each containing one single queen honeybee with a
   maximum of 20 accompanying attendants.
                                                 Article 68
       Additional guarantees for queen honeybees destined to certain Member States or zone as
                          regards the infestation with Varroa spp. (Varroosis).
   Consignments of queen honeybees destined to a Member State or zone with disease-free
   status for infestation with Varroa spp. (Varroosis) shall only be permitted to enter the Union
   if such consignments comply with the following requirements:
   (a)       the honeybees of the consignment must originate from a third country or territory or
             zone thereof free from infestation with infestation with Varroa spp. (Varroosis);
   (b)       in the third country or territory of origin or zone thereof, infestation with Varroa spp.
             (Varroosis) has not been reported for a period of 30 days prior to the date of loading
             for dispatch to the Union;
   (c)       every precaution has been taken to avoid contamination of the consignment with
             Varroa spp. during loading and dispatch to the Union.
EN                                                   66                                                EN
 ---pagebreak---                                              Chapter 3
             Specific animal health requirements for bumble bees
                                               Article 69
                              The establishment of origin of bumble bees
   Consignments of bumble bees shall only be permitted to enter the Union if the bumble bees of
   the consignment:
   (a)      have been bred and kept in an environmentally isolated bumble bee production
            establishment which:
            (i)   has facilities which ensure that the production of bumble bees is carried out
                  inside of a flying insect-proof building;
            (ii)  has facilities and equipment which ensure that the bumble bees are further
                  isolated in separate epidemiological units and each colony in closed containers
                  within the building throughout the whole production;
            (iii) the storage and handling of pollen within the facilities is isolated from the
                  bumble bees throughout the whole production of bumble bees until it is fed to
                  them;
            (iv) has standard operating procedures to prevent the entry of small hive beetle into
                  the establishment and to regularly survey for the presence of small hive beetle
                  within the establishment;
   (b)      within the establishment referred to in point (a), the bumble bees must come from an
            epidemiological unit in which infestation with Aethina tumida (Small hive beetle)
            has not been detected.
                                               Article 70
                                   The consignment of bumble bees
   Consignments of bumble bees shall only be permitted to enter the Union if such consignments
   have been dispatched to the Union in closed containers, each containing a colony of a
   maximum of 200 adult bumble bees, with or without a queen.
                                             Chapter 4
     Specific animal health requirements for handling after the entry
                         of queen honeybees and bumble bees
                                               Article 71
                    Handling after the entry of queen honeybees and bumble bees
   1.       Following their entry into the Union, queen honeybees must not be introduced in
            local colonies unless they are transferred from the transport cage to new cages in
            accordance with paragraph 2 with the permission and, as appropriate, under the
            direct supervision of the competent authority.
   2.       Following the transfer in new cages as referred to in paragraph 1, the transport cages,
            attendants, and other material that accompanied the queen honeybees from the third
            country of origin must be submitted to an official laboratory for examination to rule
EN                                                 67                                               EN
 ---pagebreak---           out the presence of Aethina Tumida (Small hive beetle), including eggs and larvae,
          and any signs of the Tropilaelaps mite.
   3.     Operators receiving bumble bees shall destroy the container and the packaging
          material that accompanied them from the third country or territory of origin but they
          may keep them in the container in which they entered into the Union until the end of
          the lifespan of the colony.
                                              Article 72
              Specific obligations for the competent authorities in the Member States
   The competent authority of the Member State of the place of destination of consignments of
   honeybees or bumble bees shall:
   (a)    supervise the transfer from the transport cage to the new cages referred to in Article
          71(1);
   (b)    ensure the submission by the operator of the materials referred to in Article 71(2);
   (c)    ensure that the official laboratory referred to in Article 71(2) have arrangements in
          place to destroy the cages, attendants and the material after the laboratory
          examination provided for in that provision.
                                             TITLE 5
      ANIMAL HEALTH REQUIREMENTS FOR ENTRY INTO THE
                     UNION OF DOGS, CATS AND FERRETS
                                              Article 73
                         Dispatch of the dogs, cats and ferrets to the Union
   1.     Consignments of dogs, cats and ferrets shall only be permitted to enter the Union if
          such consignments have been dispatched from their establishment of origin to the
          Union, without passing through any other establishment.
   2.     By way of derogation from paragraph 1, consignments of dogs, cats and ferrets
          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 assembly operation took place in an establishment:
                 (i)   approved for conducting assembly operations of dogs, cats and ferrets by
                       the competent authority in the third country or territory in accordance
                       with requirements at least as stringent as those laid down in Article 10 of
                       Commission Delegated Regulation (EU) 2019/2035;
                 (ii)  which has a unique approval number assigned by the competent authority
                       of the third country or territory;
                 (iii) 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 Commission Delegated Regulation (EU) 2019/2035;
                 (iv) where the following records are kept up-to-date for a period of at least 3
                       years:
EN                                                68                                               EN
 ---pagebreak---                         –     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 dogs, cats and
                              ferrets to and from that centre.
            (b)   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;
            (c)   the animals must have arrived in the Union within a period of 10 days from the
                  date of dispatch from the establishment of origin.
                                               Article 74
                                Identification of dogs, cats and ferrets
   1.       Consignments of dogs, cats and ferrets shall only be permitted to enter the Union if
            the animals of the consignment have been individually identified by means of an
            injectable transponder implanted by a veterinarian which fulfils the technical
            requirements for means of identification of animals laid down in implementing acts
            adopted by the Commission pursuant Article 120 of Regulation (EU) 2016/429.
   2.       Where the implanted injectable transponder referred to in paragraph 1 does not fulfil
            the technical specifications referred to in that paragraph, the operator responsible for
            entry into the Union of the consignment shall provide the reading device which
            enables the verification of the individual identification of the animal at any time.
                                               Article 75
           The third country or territory of origin or zone thereof of dogs, cats and ferrets
   Consignments of dogs, cats and ferrets 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
   rules on the prevention and control of infection with rabies virus are in force and implemented
   effectively to minimise the risk of infection of dogs, cats and ferrets, including rules on
   imports of those species from other third countries or territories.
                                               Article 76
                                       The dogs, cats and ferrets
   1.       Consignments of dogs, cats and ferrets shall only be permitted to enter the Union if
            the animals of the consignment comply with the following requirements:
            (a)   they have received a vaccination against infection with rabies virus that
                  complies with the following conditions:
                  (i)   the animals must be at least 12 weeks old at the time of vaccination;
EN                                                 69                                                EN
 ---pagebreak---                      (ii)   the vaccine must comply with the requirements set out in Annex III to
                            Regulation (EU) No 576/201318 of the European Parliament and of the
                            Council;
                     (iii) at the day of dispatch to the Union, at least 21 days must have elapsed
                            since the completion of the primary vaccination against infection with
                            rabies virus;
                     (iv) a certified copy of the vaccination details must be attached to the animal
                            health certificate referred to in Article 3(1)(c)(i).
             (b)     they must have undergone a valid rabies antibody titration test, in accordance
                     with point 1 of Annex XXI.
   2.        By way of derogation of paragraph 1(b), dogs, cats and ferrets originating in third
             countries or territories or zones thereof included in the list set out in Regulation (EU)
             No 577/201319 shall be permitted to enter the Union without being subjected to the
             rabies titration test.
   3.        Consignments of dogs shall be permitted to enter into a Member State with disease-
             free status for Echinococcus multilocularis or an approved eradication programme
             for infestation with that disease, if the animals of the consignment have been treated
             against this infestation in accordance with Part 2 of Annex XXI.
                                                    Article 77
      Derogation for dogs, cats and ferrets intended for a confined or a quarantine establishment
   By way of derogation from Article 76, consignments of dogs, cats and ferrets which do not
   comply with the requirements regarding vaccination against rabies and requirements
   regarding infestation with Echinococcus multilocularis shall be permitted to enter the Union
   provided that such consignments are intended for direct entry either to:
   (a)       a confined establishment;
   or
   (b)       an approved quarantine establishment in the Member State of destination.
                                                    Article 78
      Moving and handling after the entry into the Union of dogs, cats and ferrets intended for a
                                   confined or a quarantine establishment
   1.        Consignments of dogs, cats and ferrets intended to a confined establishment in the
             Union shall be maintained in the confined establishment of destination for a period of
             at least 60 days after the date of their entry into the Union.
   18
           Regulation (EU) No 576/2013 of the European Parliament and of the Council of 12 June 2013 on the
           non-commercial movement of pet animals and repealing Regulation (EC) No 998/2003 (OJ L 178,
           28.6.2013, p.1)
   19
           Commission Implementing Regulation (EU) No 577/2013 of 28 June 2013 on the model identification
           documents for the non-commercial movement of dogs, cats and ferrets, the establishment of lists of
           territories and third countries and the format, layout and language requirements of the declarations
           attesting compliance with certain conditions provided for in Regulation (EU) No 576/2013 of the
           European Parliament and of the Council (OJ 178, 28.6.2013, p.109)
EN                                                      70                                                      EN
 ---pagebreak---    2. Consignments of dogs, cats and ferrets intended for direct entry to an approved
      quarantine establishment as referred to in Article 77(b) shall be maintained in that
      establishment for a period of:
      (a)   not less than 6 months from the date of their arrival in the case of non-
            compliance with the requirements for vaccination against infection with rabies
            virus provided for in Article 76(1);
      or
      (b)   in the case of dogs not complying with the requirements for infestation with
            Echinococcus multilocularis provided for in Article 76(3), 24 hours following
            a treatment against infestation with Echinococcus multilocularis in accordance
            with point 2 of Annex XXI.
EN                                          71                                             EN
 ---pagebreak---                                                Part III
       Animal health requirements for entry into the Union of
         germinal products as referred to in Articles 3 and 5
                                               TITLE 1
          ANIMAL HEALTH REQUIREMENTS FOR GERMINAL
                             PRODUCTS OF UNGULATES
                                              Chapter 1
       General animal health requirements for germinal products of
                                              ungulates
                                                Article 79
                        The third country or territory of origin or zone thereof
   Consignments of semen, oocytes and embryos of bovine, porcine, ovine, caprine and equine
   animals shall only be permitted to enter the Union if they were collected from animals which
   come from third countries or territories which comply with the animal health requirements
   laid down in Article 22.
                                                Article 80
                                The residency period of donor animals
   Consignments of semen, oocytes and embryos of bovine, porcine, ovine, caprine and equine
   animals shall only be permitted to enter the Union if they were collected from animals which:
   (a)     remained for a period of at least 6 months prior to the date of collection in a third
           country or territory or zone thereof which is listed for entry into the Union of the
           particular species and category of germinal product;
   (b)     for a period of at least 30 days prior to the date of first collection of the germinal
           products and during the collection period:
           (i)    were kept on establishments not situated in a restricted zone established due to
                  the occurrence in bovine, porcine, ovine, caprine and equine animals of a
                  category A disease or of an emerging disease relevant for the bovine, porcine,
                  ovine, caprine or equine animals;
           (ii)   were kept on a single establishment on which no category D diseases relevant
                  for the bovine, porcine, ovine, caprine or equine animals were reported;
           (iii) were not in contact with animals from establishments, situated in a restricted
                  zone referred to in (i) or from establishments referred to in (ii);
           (iv) were not used for natural breeding.
EN                                                  72                                             EN
 ---pagebreak---                                                 Article 81
                                    Identification of donor animals
   Consignments of semen, oocytes and embryos of bovine, porcine, ovine, caprine and equine
   animals shall only be permitted to enter the Union if they were collected from animals which
   were identified in accordance with Article 21.
                                                Article 82
                                 The germinal product establishments
   1.      Consignments of semen, oocytes and embryos of bovine, porcine, ovine, caprine and
           equine animals shall only be permitted to enter the Union if they were dispatched
           from approved germinal product establishments which are listed by competent
           authorities of listed third countries or territories or zones thereof.
   2.      Consignments of germinal products shall only be permitted to enter the Union from
           approved germinal product establishments referred to in paragraph 1 that comply
           with the following requirements set out in Annex I to Commission Delegated
           Regulation (EU) 2019/… as regards the approval of germinal product
           establishments and the traceability and animal health requirements for movements
           within the Union of germinal products of certain kept terrestrial animals [document
           C(2019)4055]:
           (a)    Part 1 of that Annex, in respect of a semen collection centre;
           (b)    Part 2 of that Annex, in respect of an embryo collection team;
           (c)    Part 3 of that Annex, in respect of an embryo production team;
           (d)    Part 4 of that Annex, in respect of a germinal product processing
                  establishment;
           (e)    Part 5 of that Annex, in respect of a germinal product storage centre.
                                                Article 83
                                         The germinal products
   Consignments of semen, oocytes and embryos of animals of bovine, porcine, ovine, caprine
   and equine animals shall only be permitted to enter the Union if those germinal products
   comply with the following requirements:
   (a)     they are marked in such a way that the following information can be readily
           established:
           (i)    the date of collection or production of those germinal products;
           (ii)   the species and identification of the donor animal(s);
           (iii) the unique approval number, which shall include the ISO 3166-1 alpha-2 code
                  of the country in which the approval is granted;
           (iv) any other relevant information;
   (b)     they fulfil animal health requirements for the collection, production, processing and
           storage set out in Annex III to Commission Delegated Regulation (EU) 2019/… as
           regards the approval of germinal product establishments and the traceability and
           animal health requirements for movements within the Union of germinal products of
           certain kept terrestrial animals [document C(2019)4055].
EN                                                  73                                           EN
 ---pagebreak---                                                 Article 84
                                   The transport of germinal products
   1.       Consignments of semen, oocytes and embryos of animals of bovine, porcine, ovine,
            caprine and equine animals shall only be permitted to enter the Union if:
            (a)    they were placed in a container which complies with the following
                   requirements:
                   (i)   it was sealed and numbered prior to the dispatch from the approved
                         germinal product establishment under the responsibility of a centre or a
                         team veterinarian, or by an official veterinarian;
                   (ii)  it was cleaned and either disinfected or sterilised before use, or is single-
                         use container;
                   (iii) it was filled in with the cryogenic agent which was not previously used
                         for other products.
            (b)    only one type of germinal products of one species was placed in the container
                   referred to in point (a).
   2.       By the way of derogation from paragraph 1(b), operators may place in one container
            semen, oocytes and embryos of the same species provided that:
            (a)    straws or other packages in which germinal products are placed are securely
                   and hermetically sealed;
            (b)    the germinal products of different types are separated from each other by
                   physical compartments or by being placed in secondary protective bags.
   3.       By way of derogation from paragraph 1(b), operators may place in one container
            semen, oocytes and embryos of ovine and caprine animals.
                                                Article 85
                           Additional requirements for the transport of semen
   Consignments of semen bovine, porcine, ovine and caprine animals which has been collected
   from more than one donor animal and placed in a single straw or another package for the
   purposes of entry into the Union shall only be permitted to enter the Union if:
   (a)      that semen was collected and dispatched from a single semen collection centre where
            it was collected;
   (b)      there were procedures in place as regards processing of that semen in order to ensure
            that it complies with the marking requirements of point (a) of Article 83.
                                             Chapter 2
       Specific animal health requirements for germinal products of
                                           bovine animals
                                                Article 86
                          The establishment of origin of donor bovine animals
   Consignments of semen, oocytes and embryos of bovine animals shall only be permitted to
   enter the Union if they were collected from animals which came from establishments that
EN                                                  74                                                 EN
 ---pagebreak---    comply with the following requirements and those animals have never been kept previously in
   any establishment of a lower health status:
   (a)      comply with the requirements of Article 23;
   (b)      in the case of donor animals of semen prior to their admission to a quarantine
            accommodation, were free from the following diseases:
            (i)    infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and
                   M. tuberculosis);
            (ii)   infection with Brucella abortus, B. melitensis and Br. suis;
            (iii) enzootic bovine leukosis;
            (iv) infectious bovine rhinotracheitis/ infectious pustular vulvovaginitis.
                                                Article 87
     Derogations from the requirements for the establishment of origin of donor bovine animals
   1.       By the way of derogation from Article 86(b)(iii), consignments of semen of bovine
            animals shall be permitted to enter the Union if a donor animal comes from an
            establishment which is not free from enzootic bovine leukosis and:
            (a)    is younger than 2 years of age and which has been produced by a dam which
                   has been subjected, with negative results, to a serological test for enzootic
                   bovine leukosis after removal of the animal from the dam;
            or
            (b)    has reached the age of 2 years and has been subjected, with a negative result, to
                   a serological test for enzootic bovine leukosis.
   2.       By the way of derogation from Article 86(b)(iii), consignments of oocytes and
            embryos of bovine animals shall be permitted to enter the Union if a donor animal
            comes from an establishment which is not free from enzootic bovine leukosis and is
            less than 2 years of age, and provided that the official veterinarian responsible for the
            establishment of origin has certified that there has been no clinical case of enzootic
            bovine leukosis during a period of at least the preceding 3 years.
   3.       By the way of derogation from Article 86(b)(iv), consignments of semen, oocytes
            and embryos of bovine animals shall be permitted to enter the Union if a donor
            animal comes from an establishment which is not free from infectious bovine
            rhinotracheitis/infectious pustular vulvovaginitis, provided that:
            (a)    in the case of semen, the animal has been subjected, with a negative result, to a
                   test required in accordance with point 1(b)(iv) of Chapter I of Part 1 of Annex
                   II to Commission Delegated Regulation (EU) 2019/… as regards the approval
                   of germinal product establishments and the traceability and animal health
                   requirements for movements within the Union of germinal products of certain
                   kept terrestrial animals [document C(2019)4055];
            (b)    in the case of oocytes or embryos, the official veterinarian responsible for the
                   establishment of origin has certified that there has been no clinical case of
                   infectious bovine rhinotracheitis/infectious pustular vulvovaginitis during a
                   period of at least the preceding 12 months.
EN                                                  75                                                EN
 ---pagebreak---                                                  Article 88
                     Specific animal health requirements for donor bovine animals
   Consignments of semen, oocytes or embryos shall only be permitted to enter the Union if they
   were collected from donor bovine animals that comply with the animal health requirements
   laid down in Part 1 and Chapters I, II and III of Part 5 of Annex II to Commission Delegated
   Regulation (EU) 2019/… as regards the approval of germinal product establishments and the
   traceability and animal health requirements for movements within the Union of germinal
   products of certain kept terrestrial animals [document C(2019)4055].
                                               Chapter 3
       Specific animal health requirements for germinal products of
                                          porcine animals
                                                 Article 89
                         The establishment of origin of donor porcine animals
   1.       Consignments of semen, oocytes and embryos of porcine animals shall only be
            permitted to enter the Union if they were collected from animals which came from
            establishments:
            (a)    which comply with the requirements laid down in Article 23;
            (b)    in the case of donor animals of semen prior their admission to a quarantine
                   accommodation, in which no clinical, serological, virological or pathological
                   evidence of infection with Aujeszky’s disease virus had been detected during
                   the period of at least the preceding 12 months.
   2.       Consignments of semen of porcine animals shall only be permitted to enter the Union
            if they were collected from animals:
            (a)    prior to their admission to a quarantine accommodation, which came from
                   establishments which were free from infection with Brucella abortus, B.
                   melitensis and B. suis in accordance with requirements laid down in Chapter IV
                   of Part 5 of Annex II to Commission Delegated Regulation (EU) 2019/… as
                   regards the approval of germinal product establishments and the traceability
                   and animal health requirements for movements within the Union of germinal
                   products of certain kept terrestrial animals [document C(2019)4055];
            (b)    which were kept at a quarantine accommodation which on the date of
                   admission was free of infection with Brucella abortus, B. melitensis and B. suis
                   for a period of at least the 3 months preceding that date;
            (c)    which were kept in a semen collection centre in which no clinical, serological,
                   virological or pathological evidence of infection with Aujeszky’s disease virus
                   was reported for the period of at least 30 days prior to the date of admission
                   and of at least 30 days immediately prior to the date of collection;
            (d)    which were kept, since birth or for at least 3 months prior to the date of entry
                   into the quarantine accommodation, in an establishment in which no animals
                   were vaccinated against infection with porcine reproductive and respiratory
                   syndrome virus and no infection with porcine reproductive and respiratory
                   syndrome virus was detected within that period.
EN                                                   76                                             EN
 ---pagebreak---                                               Article 90
                   Specific animal health requirements for donor porcine animals
   Consignments of semen, oocytes or embryos shall only be permitted to enter the Union if they
   were collected from donor porcine animals that:
   (a)     comply with the specific animal health requirements laid down in Part 2 and
           Chapters I, II, III and IV of Part 5 of Annex II to Commission Delegated Regulation
           (EU) 2019/… as regards the approval of germinal product establishments and the
           traceability and animal health requirements for movements within the Union of
           germinal products of certain kept terrestrial animals [document C(2019)4055];
   (b)     were not vaccinated against infection with porcine reproductive and respiratory
           syndrome virus.
                                            Chapter 4
       Specific animal health requirements for germinal products of
                                 ovine and caprine animals
                                              Article 91
                  The establishment of origin of donor ovine and caprine animals
   Consignments of semen, oocytes and embryos of ovine and caprine animals shall only be
   permitted to enter the Union if they were collected from donor animals which:
   (a)     did not come from an establishment, nor been in contact with animals from an
           establishment, in the case of a kept donor animal of semen prior to its admission to a
           quarantine accommodation, which has been subjected to movement restrictions as
           regards infection with Brucella abortus, B. melitensis and B. suis. The movement
           restrictions concerning the establishment are lifted after the period comprising at
           least 42 days from the date of the slaughter and the disposal of the last animal
           infected or susceptible to that disease;
   (b)     come from an establishment, that was free from infection with B. abortus, B.
           melitensis and B. suis and has never been kept previously in any establishment of a
           lower status.
                                              Article 92
             Specific animal health requirements for donor ovine and caprine animals
   Consignments of semen, oocytes or embryos of ovine and caprine animal shall only be
   permitted to enter the Union if they were collected from donor animals that fulfil specific
   animal health requirements laid down in Part 3 and Chapters I, II and III of Part 5 of Annex II
   to Commission Delegated Regulation (EU) 2019/… as regards the approval of germinal
   product establishments and the traceability and animal health requirements for movements
   within the Union of germinal products of certain kept terrestrial animals [document
   C(2019)4055].
EN                                                77                                               EN
 ---pagebreak---                                             Chapter 5
       Specific animal health requirements for germinal products of
                                        equine animals
                                              Article 93
                         The establishment of origin of donor equine animals
   Consignments of semen, oocytes and embryos of equine animals shall only be permitted to
   enter the Union if they were collected from donor animals which come from establishments
   which comply with the requirements laid down in Article 23.
                                              Article 94
                    Specific animal health requirements for donor equine animals
   Consignments of semen, oocytes or embryos of equine animals shall only be permitted to
   enter the Union if the donor animals of those germinal products comply with the requirements
   laid down Article 24(1)(a)(ii) and (b)(ii) and Article 24(6) of this Regulation, and the
   additional specific animal health requirements laid down in Part 4 of Annex II to Commission
   Delegated Regulation (EU) 2019/… as regards the approval of germinal product
   establishments and the traceability and animal health requirements for movements within the
   Union of germinal products of certain kept terrestrial animals [document C(2019)4055].
                                            Chapter 6
       Special rules for germinal products of ungulates intended for
                                  confined establishments
                                              Article 95
                Germinal products intended for confined establishments in the Union
   Consignments of semen, oocytes and embryos of bovine, porcine, ovine, caprine and equine
   animals dispatched from confined establishments in third countries or territories listed in
   accordance with Article 29 shall only be permitted to enter the Union if they are dispatched to
   a confined establishment in the Union subject to compliance with the following requirements:
   (a)      an assessment was carried out by the competent authority of the Member State of
            destination of the risks associated with the entry into the Union of those germinal
            products;
   (b)      the donor animals of those germinal products originate from a confined
            establishment in the third country or territory of origin or zone thereof, which is
            included in a list established in accordance with Article 29 of confined
            establishments from which the entry of ungulates into the Union may be authorised;
   (c)      the germinal products are destined to a confined establishment in the Union, which is
            approved in accordance with Article 95 of Regulation (EU) 2016/429;
   (d)      the germinal products are transported directly to the confined establishment referred
            to in point (c).
EN                                                78                                               EN
 ---pagebreak---                                                 Article 96
        Specific animal health requirements for donor animals kept in confined establishment
   Consignments of the germinal products referred to in Article 95 shall be only permitted to
   enter the Union if they were collected from donor animals that comply with the following
   requirements:
   (a)       the donor animals did not come from an establishment, nor been in contact with
             animals from an establishment, situated in a restricted zone established due to the
             occurrence of a category A disease or of an emerging disease relevant for the bovine,
             porcine, ovine, caprine or equine animals;
   (b)       the donor animals come from an establishment where none of the category D
             diseases relevant for bovine, porcine, ovine, caprine or equine animals have been
             reported for a period of at least 30 days prior to the date of collection of the semen,
             oocytes or embryos;
   (c)       the donor animals remained in a single confined establishment of origin for a period
             of at least 30 days prior to the date of collection of semen, oocytes or embryos
             intended for entry into the Union and during the period of that collection;
   (d)       the donor animals were clinically examined by the establishment veterinarian
             responsible for the activities carried out at confined establishment, and showed no
             disease symptoms on the day the semen, oocytes or embryos were collected;
   (e)       as much as possible, the donor animals were not used for natural breeding during a
             period of at least 30 days prior to the date of first collection of semen, oocytes or
             embryos intended for entry into the Union and during the period of that collection;
   (f)       the donor animals are identified in accordance with Article 21.
                                                Article 97
             The requirements for germinal products obtained in confined establishments
   Consignments of germinal products referred to in Article 95 shall only be permitted to enter
   the Union if they are:
   (a)       marked in accordance with the information requirements provided for in point (a) of
             Article 83;
   (b)       transported in accordance with Articles 84 and 85.
                                               TITLE 2
      ANIMAL HEALTH REQUIREMENTS FOR HATCHING EGGS
                         OF POULTRY AND CAPTIVE BIRDS
                                             Chapter 1
                   Animal health requirements for hatching eggs
                                                Article 98
                                          The residency period
   Consignments of hatching eggs shall only be permitted to enter the Union if, immediately
   prior to the date of loading of the hatching eggs for dispatch to the Union the flock of origin
   of the hatching eggs has complied, for a continuous period of time, with the residency periods
   requirements set out in Annex XXII, and during that time the flock of origin has:
EN                                                  79                                               EN
 ---pagebreak---    (a)       remained in the third country or territory of origin or zone thereof;
   (b)       remained in the establishment of origin, and no animals have been introduced into
             that establishment during that period of time prior to loading;
   (c)       had no contact with poultry or hatching eggs of a lower health status, or with captive
             birds or wild birds.
                                                  Article 99
                        Handling of hatching eggs during transport to the Union
   Consignments of hatching eggs shall only be permitted to enter the Union if the germinal
   products of the consignment comply with the following requirements:
   (a)       the hatching eggs intended for entry into the Union must not have come into contact
             with poultry, captive birds or hatching eggs not intended for entry into the Union or
             of a lower health status from the time of loading at the establishment of origin for
             dispatch to the Union until the time of arrival in the Union;
   (b)       the hatching eggs must not have been transported, unloaded in, or moved to another
             means of transport when transported by road, by sea or by air through a third country
             or territory or zone thereof which is not listed for entry of the particular species and
             category of hatching eggs into the Union.
                                                 Article 100
       Derogation and additional requirements for transhipment of hatching eggs in case of an
                        incident in the means of transport by waterway or by air
   By way of derogation from point (b) of Article 99, consignments of hatching eggs which have
   been transhipped from the 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 listed for entry of
   hatching eggs into the Union, shall only be permitted to enter the Union if the transhipment
   took place because of the occurrence of a technical problem or another unforeseen incident
   causing logistic problems during the transport of the hatching eggs to the Union by sea or by
   air, in order to complete the transport to the point of entry into Union, and provided that:
   (a)       the entry into the Union of the hatching eggs is authorised by the competent authority
             of the Member State of destination and, where applicable, the Member States of
             passage until their arrival at their place of destination in the Union;
   (b)       the transhipment was supervised by an official veterinarian or the responsible
             customs officer and throughout the operation:
             (i)    effective measures were put in place to avoid any direct or indirect contact
                    between the hatching eggs intended for entry into the Union and any other
                    hatching eggs or animals;
             (ii)   the hatching eggs were transferred directly and as quick as possible to the
                    vessel or aircraft to be used for onward travel to the Union, which complies
                    with requirements laid down in Article 17, without leaving the premises of the
                    port or airport;
   (c)       the hatching eggs are accompanied by a declaration from the competent authority of
             the third country or territory where the transfer took place, providing the necessary
             information on the transfer operation and attesting that the relevant measures were
             put in place to comply with the requirements laid down in point (b).
EN                                                    80                                              EN
 ---pagebreak---                                                Article 101
                                 Transport by vessel of hatching eggs
   1.      Consignments of hatching eggs transported by ship, even for part of the journey,
           shall only be permitted to enter the Union if the germinal products of the
           consignment comply with the following requirements:
           (a)    hatching eggs:
                  (i)   have remained on board the vessel during the whole transport;
                  (ii)  have not been in contact with birds or other hatching eggs of a lower
                        health status while on board the vessel;
           (b)    hatching eggs transported in accordance with point (a) must be accompanied
                  by a declaration, providing the following information:
                  (i)   the port of departure in the third country or territory of origin or zone
                        thereof;
                  (ii)  the port of arrival in the Union;
                  (iii) where the vessel called at ports outside the third country or territory of
                        origin or zone thereof of the consignment, indicating the ports of call;
                  (iv) that the hatching eggs complied during the transport with the
                        requirements set out in point (a) and (i), (ii) and (iii) of this point.
   2.      The operator responsible for the consignment of hatching eggs shall ensure that the
           declaration provided for in paragraph 1, is attached to the animal health certificate
           and signed by the master of the vessel at the port of arrival on the day of arrival of
           the vessel.
                                               Article 102
        Preventive measures for the means of transport and the containers of hatching eggs
   Consignments of hatching eggs shall only be permitted to enter the Union if the germinal
   products of the consignment comply with the following requirements:
   (a)     the hatching eggs must have been transported in vehicles which:
           (i)    are constructed in such a way that hatching eggs cannot fall out;
           (ii)   have been designed to allow cleaning and disinfection;
           (iii) have been cleaned and disinfected with a disinfectant authorised by the
                  competent authority of the third country or territory of origin, and dried or
                  allowed to dry immediately before every loading of hatching eggs intented for
                  entry into the Union;
   (b)     the hatching eggs must have been transported in containers which comply with the
           following requirements:
           (i)    the requirements of point (a);
           (ii)   they contain only hatching eggs of the same species, category and type which
                  come from the same establishment;
           (iii) they were closed in accordance with the instructions of the competent authority
                  of the third country or territory of origin to avoid any possibility of substitution
                  of the content;
EN                                                 81                                                  EN
 ---pagebreak---              (iv) they were:
                    –      cleaned and disinfected before loading in accordance with the
                           instructions of the competent authority of the third country or territory of
                           origin;
                           or
                    –      they are disposable, clean and used for the first time;
             (v)    they bear the information for the particular species and category of hatching
                    eggs set out in Annex XVI.
                                                  Article 103
                         Movement and handling of hatching eggs after the entry
   Following their entry into the Union, operators, including transporters, shall ensure that
   consignments of hatching eggs are:
   (a)       transported directly from the point of entry to their place of destination in the Union;
   (b)       comply with the requirements for movement within the Union and handling
             following their entry into the Union as laid down for the particular species and
             category of hatching eggs in Chapters 5 and 7 of this Title.
                                                Chapter 2
     Specific animal health requirements for hatching eggs of poultry
                                                  Article 104
    Hatching eggs originating from poultry imported into the third country or territory of origin
                                                or zone thereof
   Consignments of hatching eggs of poultry, which originate from flocks which were imported
   into the third country, or territory of origin or zone thereof from another third country or
   territory or zone thereof, shall only be permitted to enter the Union if the competent authority
   of the third country or territory of origin of the hatching eggs has provided guarantees that:
   (a)       the flocks of origin of the hatching eggs were imported from a third country or
             territory or zone thereof, which is listed for entry into Union of such flocks;
   (b)       the import of the flocks of origin of the hatching eggs into that third country or
             territory or zone thereof took place in accordance with animal health requirements
             that are at least as stringent as if they were directly entered into the Union.
                                                  Article 105
              The third country or territory of origin or zone thereof of the hatching eggs
   Consignments of hatching eggs of poultry shall only be permitted to enter the Union if they
   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;
EN                                                    82                                                EN
 ---pagebreak---        or
       (ii)   the relevant Chapter of the Terrestrial Animal Health Code of the World
              Organisation for Animal Health (OIE);
   (b) which is considered to be free from highly pathogenic avian influenza in accordance
       with Article 38;
   (c) if it carries out vaccination against highly pathogenic avian influenza, the competent
       authority of the third country or territory of origin has provided guarantees that:
       (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 hatching eggs of poultry other than ratites, is considered to be
              free from infection with Newcastle disease virus in accordance with Article 39;
       (ii)   in the case of hatching eggs of ratites:
              –      it is considered to be free from infection with Newcastle disease virus in
                     accordance with Article 39;
                     or
              –      it is not considered to be 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) if 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:
EN                                               83                                                EN
 ---pagebreak---             (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 of the disease situation;
   (g)      which has undertaken to submit virus isolates from initial outbreaks of highly
            pathogenic avian influenza or infection with Newcastle disease virus to the European
            Union Reference Laboratory for Avian Influenza and Newcastle disease.
                                               Article 106
                           The establishment of origin of the hatching eggs
   Consignments of hatching eggs of poultry shall only be permitted to enter the Union if they
   originate from:
   (a)      hatcheries approved by the competent authority of the third country or territory of
            origin in accordance with requirements which are at least as stringent as those laid
            down in Article 7 of Commission Delegated Regulation (EU) 2019/2035; and
            (i)   the approval of which has not been suspended or withdrawn;
            (ii)  within a 10 km radius of those hatcheries, 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 for a
                  period of at least 30 days prior to the time of loading of the hatching eggs for
                  dispatch to the Union;
            (iii) which have been assigned a unique approval number by the competent
                  authority of the third country or territory of origin;
   (b)      flocks which have been kept in establishments approved by the competent authority
            of the third country or territory of origin in accordance with requirements which are
            at least equivalent to those laid down in Article 8 of Commission Delegated
            Regulation (EU) 2019/2035 and
            (i)   the approval of which has not been suspended or withdrawn;
            (ii)  within a 10 km radius of those establishments, 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 for a
                  period of at least 30 days prior to the date of collection of the hatching eggs for
                  dispatch to the Union;
            (iii) no confirmed case of infection with low pathogenic avian influenza viruses has
                  been reported in those establishments within a period of at least 21 days prior
                  to the date of collection of the eggs for dispatch to the Union.
                                               Article 107
                                The flock of origin of the hatching eggs
   Consignments of hatching eggs of poultry shall only be permitted to enter the Union if they
   originate from flocks which comply with the following requirements:
   (a)      where they have been vaccinated against highly pathogenic avian influenza,
            guarantees for compliance with the minimum requirements for vaccination
EN                                                  84                                                EN
 ---pagebreak---        programmes and additional surveillance set out in Annex XIII, have been provided
       by the third country or territory of origin;
   (b) where 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 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) they have undergone a disease surveillance programme that meets the requirement
       set out Annex II of Commission 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 Mycoplamsa 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) they were kept in establishments which, in case of confirmation of infection with
       Salmonella Pullorum, S. Gallinarum and S. arizonae during the last 12 months prior
       to date of collection of the eggs for dispatch to the Union have applied the following
       measures:
       (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) they were kept in establishments which in case of confirmation of avian
       mycoplasmosis (Mycoplasma gallisepticum and M. meleagridis) during the last 12
       months prior to date of collection of the eggs for dispatch to the Union have applied
       the following measures:
       either
EN                                              85                                                EN
 ---pagebreak---           (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);
   (f)    they have been subjected to a clinical inspection, carried out by an official
          veterinarian in the third country or territory of origin or zone thereof, within a period
          of 24 hours prior to the time of loading of the consignment of hatching eggs for
          dispatch to the Union for the purpose of the detection of signs indicative of the
          occurrence of diseases, including the relevant listed diseases referred to in Annex I
          and emerging diseases and they showed no disease symptoms or grounds for
          suspecting the presence of any of those diseases.
                                              Article 108
                                The hatching eggs of the consignment
   Consignments of hatching eggs of poultry shall only be permitted to enter the Union if they
   comply with the following requirements:
   (a)    if the hatching eggs have been vaccinated against highly pathogenic avian influenza,
          guarantees for compliance with the minimum requirements for vaccination
          programmes and additional surveillance set out in Annex XIII, have been provided
          by the third country or territory of origin;
   (b)    if the hatching eggs 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;
           (ii) the information set out in point 4 of Annex XV must be provided for the
                 consignment;
   (c)    the hatching eggs must be marked:
          (i)    using colour ink;
          (ii)   in the case of hatching eggs of poultry other than ratites, with a stamp
                 indicating the unique approval number of the establishment of origin referred
                 to in Article 106;
          (iii) in the case of hatching eggs of ratites, with a stamp indicating the ISO code of
                 the third country or territory of origin and the unique approval number of the
                 establishment of origin referred to in Article 106;
   (d)    the hatching eggs must have been disinfected in accordance with the instructions of
          the competent authority of the third country or territory of origin.
EN                                                86                                                EN
 ---pagebreak---                                                 Article 109
       Entry of hatching eggs into Member States with status free from infection with Newcastle
                                     disease virus without vaccination
   Consignments of hatching eggs intended for a Member State with status free from infection
   with Newcastle disease virus without vaccination, shall only be permitted to enter the Union
   if they:
   (a)       are not vaccinated against infection with Newcastle disease virus;
   (b)       originate from flocks which comply with the requirements set out in one of the
             following points:
             (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 within the period of 60 days prior to the date of
                    collection of the eggs.
                                               Chapter 3
    Specific animal health requirements for consignments of less than
                     20 hatching eggs of poultry other than ratites
                                                Article 110
       Derogations and special requirements for consignments of less than 20 hatching eggs of
                                         poultry other than ratites
   By way of derogation from Articles 101, 102, 106, 107 and 108, consignments of less than 20
   hatching eggs of poultry other than ratites shall be permitted to enter the Union if they comply
   with the following requirements:
   (a)       they come from establishments:
             (i)    registered by the competent authority of the third country or territory of origin;
             (ii)   where no confirmed case of infection with low pathogenic avian influenza
                    viruses was reported within the period of 21 days prior to the date of collection
                    of the hatching eggs;
             (iii) within a 10 km radius of the establishments, 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 for a
                    period of at least 30 days prior to the date of collection of the hatching eggs.
   (b)       in relation to vaccination against highly pathogenic avian influenza:
             (i)    the hatching eggs have not been vaccinated against highly pathogenic avian
                    influenza;
             (ii)   where the flocks of origin have been vaccinated against highly pathogenic
                    avian influenza, guarantees for compliance with the minimum requirements for
EN                                                   87                                                EN
 ---pagebreak---               vaccination programmes and additional surveillance set out in Annex XIII,
              have been provided by the third country or territory of origin;
   (c) in relation to vaccination against Newcastle disease virus, the hatching eggs have not
       been vaccinated against Newcastle disease virus and where the flock of origin has
       been vaccinated against infection with Newcastle disease virus:
       (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 hatching
                     eggs 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;
   (d) they come from flocks which have been subjected to a clinical inspection, carried out
       by an official veterinarian in the third country or territory or origin or zone thereof,
       within 24 hours prior to the time of loading of the consignments of hatching eggs for
       dispatch to the Union for the purpose of the detection of signs indicative of the
       occurrence of diseases, including the relevant listed diseases referred to in Annex I
       and emerging diseases and the flocks showed no disease symptoms or grounds for
       suspecting the presence of any of those diseases;
   (e) they come from flocks which:
       (i)    have been isolated on the establishment of origin for a period of at least 21
              days prior to the collection of the eggs;
       (ii)   were found not to be infected or showed any grounds for suspecting any
              infection by the following agents, in tests performed in accordance with the
              requirements for testing of consignments of less than 20 heads of poultry other
              than ratites and less than 20 hatching eggs thereof prior to the entry into the
              Union, set out in Annex XVII:
              –      Salmonella Pullorum, Salmonella Gallinarum               and   Mycoplasma
                     gallisepticum in case of Gallus gallus;
              –      Salmonella arizonae (serogroup O:18(k)), Salmonela Pullorum,
                     Salmonella Gallinarum, Mycoplasma meleagridis and Mycoplasma
                     gallisepticum in case of Meleagris gallopavo;
              –      Salmonella Pullorum and Salmonella Gallinarum in case of Numida
                     meleagris, Coturnix coturnix, Phasianus colchicus, Perdix perdix, Anas
                     spp.
EN                                              88                                               EN
 ---pagebreak---                                               Chapter 4
     Specific animal health requirements for specified pathogen-free
                                                  eggs
                                               Article 111
                 Derogation and special requirements for specified pathogen-free eggs
   By way of derogation from the residency period requirements of Article 98, the specific
   animal health requirements of Articles 105 to 110 and Articles 112 to 114, consignments of
   specified pathogen-free eggs which do not comply with the animal health requirements laid
   down in those provisions, shall be permitted to enter the Union if they comply instead with
   the following animal health requirements:
   (a)      they originate from flocks which:
            (i)    are free from specified pathogens as described in the European Pharmacopoeia
                   and the results of all tests and clinical examinations required for this specific
                   status have been favourable, including negative testing results for highly
                   pathogenic avian influenza, infection with Newcastle disease virus and
                   infection with low pathogenic avian influenza viruses carried out within the
                   period of 30 days prior to the date of collection of the eggs for dispatch to the
                   Union;
            (ii)   have been clinically examined at least once a week as described in the
                   European Pharmacopoeia and no disease symptoms or ground for suspecting
                   the presence of any disease were detected;
            (iii) have been kept for a period of at least 6 weeks prior to the date of collection of
                   the eggs for dispatch to the Union in establishments which comply with the
                   conditions described in the European Pharmacopoeia;
            (iv) have had no contact with poultry not meeting the requirements of this Article
                   or with wild birds for a period of at least 6 weeks prior to the date of collection
                   of the eggs for dispatch to the Union;
   (b)      they have been marked using colour ink with a stamp bearing the ISO code of the
            third country or territory of origin and the unique approval number of the
            establishment of origin;
   (c)      they have been disinfected in accordance with the instructions of the competent
            authority of the third country or territory of origin.
EN                                                  89                                                 EN
 ---pagebreak---                                             Chapter 5
    Specific animal health requirements for movement and handling
       of hatching eggs of poultry after entry into the Union and of
                           poultry hatched from those eggs
                                             Article 112
    Obligations on operators as regards handling of hatching eggs following their entry into the
                      Union and of poultry hatched from those hatching eggs
   1.      Operators at the establishment of destination shall place hatching eggs of poultry
           which have entered into the Union from a third country or territory or zone thereof
           either in:
           (a)   separate incubators, including separate hatchers, from other hatching eggs;
           or
           (b)   incubators, including hatchers, where other hatching eggs are already present.
   2.      Operators, as referred to in paragraph 1, shall ensure that breeding poultry and
           productive poultry which have been hatched from hatching eggs referred to in that
           paragraph, are kept for a continuous period of time:
           (a)   in the hatchery for a period of at least 3 weeks from the date of hatching;
           or
           (b)   on the establishments to which the poultry has been sent after hatching, either
                 in the same Member State or in another Member State, for a period of at least 3
                 weeks from the date of hatching.
   3.      During the periods provided for in paragraph 2, operators shall keep poultry, which
           have been hatched from hatching eggs that have entered into the Union, separate
           from other flocks of poultry.
   4.      Where breeding poultry and productive poultry, which have been hatched from
           hatching eggs that have entered into the Union from a third country or territory or
           zone thereof, were introduced into premises or enclosures where other poultry are
           present, the relevant periods provided for in paragraph 2 shall commence from the
           date of introduction of the last bird and no poultry shall be moved from the premises
           or enclosures before the end of those periods.
   5.      Where hatching eggs of poultry, which have entered into the Union from a third
           country or territory or zone thereof, were introduced in incubators, including
           hatchers, where other hatching eggs were already present:
           (a)   the provisions of paragraphs 2 to 4 shall apply to all poultry hatched from the
                 hatching eggs in the same incubator, including hatcher, as the hatching eggs
                 which have entered into the Union from a third country or territory or zone
                 thereof;
           (b)   the relevant periods referred to in paragraph 2 shall commence from the date of
                 hatching of the last hatching egg that has entered into the Union from a third
                 country or territory or zone thereof.
EN                                                90                                             EN
 ---pagebreak---                                                  Article 113
                         Sampling and testing following the entry into the Union
   The competent authority of the Member State of destination shall ensure that breeding poultry
   and productive poultry which have been hatched from hatching eggs that have entered into the
   Union from a third country or territory or zone thereof undergo a clinical examination carried
   out by an official veterinarian on the establishment of destination no later than the date of
   expiry of the relevant periods as provided for Article 112(2), and, where necessary, shall be
   sampled for testing to monitor their state of health.
                                                 Article 114
       Obligation on the competent authorities as regards sampling and testing of ratites from
       hatching eggs originating from a third country or territory or zone thereof not free from
                                   infection with Newcastle disease virus
   The competent authority of the Member State of destination shall ensure that ratites which
   have hatched from hatching eggs that have entered into the Union from a third country or
   territory or zone thereof that is not free from infection with Newcastle disease virus, during
   the periods provided for in Article 112(2):
   (a)       they undergo a virus detection test for infection with Newcastle disease virus carried
             out by the competent authority on a cloacal swab or faeces sample from each ratite;
   (b)       in the case of ratites destined for a Member State with status free from infection with
             Newcastle disease virus without vaccination, in addition to the requirements referred
             to in point (a), they are subjected to a serological test for infection with Newcastle
             disease virus carried out by the competent authority on each ratite;
   (c)       all ratites shall have tested negative to the tests provided for in points (a) and (b)
             prior to their release from isolation.
                                               Chapter 6
     Specific animal health requirements for hatching eggs of captive
                                                   birds
                                                 Article 115
                                   The hatching eggs of the consignment
   Consignments of hatching eggs of captive birds shall only be permitted to enter the Union if
   they were obtained from captive birds which comply with the requirements for entry into the
   Union set out in Articles 55 to 58.
                                               Chapter 7
     Specific animal health requirements for movement and handling
    of hatching eggs of captive birds after entry into the Union and of
                          captive birds hatched from those eggs
                                                 Article 116
    Handling of hatching eggs of captive birds following their entry into the Union and of captive
                                  birds hatched from those hatching eggs
   Operators at the establishment of destination shall:
EN                                                   91                                              EN
 ---pagebreak---    (a)      place the hatching eggs of captive birds which have entered into the Union from a
            third country or territory or zone thereof in separate incubators, including hatchers,
            from other hatching eggs;
   (b)      ensure that captive birds which are hatched from the hatching eggs of captive birds
            referred to in Article 115 are kept in an approved quarantine establishment in
            accordance with the requirements of Articles 59 to 61.
                                               TITLE 3
        ANIMAL HEALTH REQUIREMENTS FOR GERMINAL PRODUCTS OF
       ANIMALS OTHER THAN UNGULATES AND OTHER THAN HATCHING
       EGGS OF POULTRY AND CAPTIVE BIRDS INTENDED FOR CONFINED
                                        ESTABLISHMENTS
                                               Article 117
    Requirements for entry into the Union of consignments of germinal products of animals other
         than those referred to in point (a) and (b) of Article 1(4) dispatched from confined
                                             establishments
   Consignments of semen, oocytes and embryos of animals other than those referred to in point
   (a) and (b) of Article 1(4) dispatched from confined establishments listed in accordance with
   Article 29 shall only be permitted to enter the Union if they are dispatched to a confined
   establishment located in the Union and provided that:
   (a)      an assessment has been carried out by the competent authority of the Member State
            of destination of the risks that the entry of those germinal products may present for
            the Union;
   (b)      the donor animals of those germinal products originate from a third country, territory
            or zone authorised for entry into the Union of the particular species and category of
            animals;
   (c)      the donor animals of those germinal products originate from a confined
            establishment in the third country, territory or zone of origin, which is included in a
            list established in accordance with Article 29 of confined establishments from which
            the entry of animals of specific species into the Union may be authorised;
   (d)      the germinal products are destined to a confined establishment in the Union, which is
            approved in accordance with Article 95 of Regulation (EU) 2016/429;
   (e)      the germinal products are transported directly to the confined establishment referred
            to in point (d).
                                               Article 118
                         Specific animal health requirements for donor animals
   Consignments of semen, oocytes and embryos referred to in Article 117 shall only be
   permitted to enter the Union if they were collected from donor animals which comply with the
   following requirements:
   (a)      they do not come from an establishment, nor have been in contact with animals from
            an establishment, situated in a restricted zone established due to the occurrence of a
            category A disease or of an emerging disease relevant for the species of those kept
            terrestrial animals;
EN                                                 92                                               EN
 ---pagebreak---    (b)     they come from an establishment where no category D disease relevant for the
           species of those kept terrestrial animals has been reported for a period of at least the
           preceding 30 days;
   (c)     they have remained in a single confined establishment of origin for a period of at
           least 30 days prior to the collection of the semen, oocytes or embryos intended for
           entry into the Union;
   (d)     they have been clinically examined by the establishment veterinarian responsible for
           the activities of the confined establishment, and showed no disease symptoms on the
           day the semen, oocytes or embryos were collected;
   (e)     as much as possible, they were not used for natural breeding during a period of at
           least 30 days prior to the date of first collection and during the period of collection of
           semen, oocytes or embryos intended for entry into the Union;
   (f)     they are identified and registered in accordance with the rules of that confined
           establishment.
                                              Article 119
                               The requirements for germinal products
   Consignments of semen, oocytes and embryos referred to in Article 117 shall only be
   permitted to enter the Union if they comply with the following requirements:
   (a)     they are marked in such a way that the following information can be readily
           established:
           (i)    the date of collection or production of those germinal products;
           (ii)   the species, where necessary subspecies, and identification of the donor
                  animal(s);
           (iii) the unique approval number of the confined establishment, which shall include
                  the ISO 3166-1 alpha-2 code of the country in which the approval is granted;
           (iv) any other relevant information.
   (b)     they are transported in the container which:
           (i)    is sealed and numbered prior to the dispatch from the confined establishment
                  by the establishment veterinarian responsible for the activities of the confined
                  establishment;
           (ii)   has been cleaned and either disinfected or sterilised before use, or is single-use
                  container;
           (iii) has been filled in with the cryogenic agent which not have been previously
                  used for other products.
EN                                                 93                                                 EN
 ---pagebreak---                                               PART IV
    Animal health requirements for entry into the Union of products
                 of animal origin as referred to in Articles 3 and 5
                                               TITLE 1
      GENERAL ANIMAL HEALTH REQUIREMENTS FOR ENTRY
         INTO THE UNION OF PRODUCTS OF ANIMAL ORIGIN
                                                Article 120
                               Time constraints for the date of production
   1.       Consignments of products of animal origin shall only be permitted to enter the Union
            if the products of the consignment were not obtained during a period where:
            (a)    animal health restriction measures were adopted by the Union for entry of such
                   products from the third country or territory of origin or zone thereof;
            (b)    the authorisation for entry into the Union of such products from the third
                   country or territory of origin or zone thereof was suspended.
                                                Article 121
                         Treatment requirements for products of animal origin
   1.       Consignments of products of animal origin, other than fresh or raw, shall only be
            permitted to enter the Union if the products of the consignment have been treated in
            accordance with Titles 3 to 6 of this Part.
            The treatment referred to in the first subparagraph must have been:
            (a)    specifically assigned by the Union in the list, to the third country or territory of
                   origin or zone thereof and to the species of origin of the product of animal
                   origin;
            (b)    applied in a third country or territory or zone thereof listed for entry into the
                   Union of the particular species and category of products of animal origin;
            (c)    applied in accordance with requirements for:
                   (i)   risk-mitigating treatments for meat products set out in Annex XXVI;
                   (ii)  risk-mitigating treatments for dairy products set out in Annex XXVII;
                   (iii) risk-mitigating treatments for egg products set out in Annex XXVIII.
   2.       After the completion of the treatment provided for in paragraph 1, products of animal
            origin must be handled until packaged in a way to prevent any cross contamination
            that could introduce an animal health risk.
                                                Article 122
          Requirements concerning the means of transport of the products of animal origin
   Consignments of products of animal origin shall only be permitted to enter the Union if such
   consignments were transported in a means of transport designed, constructed and maintained
   in such a way that the health status of the products of animal origin was not jeopardised
   during the transport from their place of origin to the Union.
EN                                                  94                                                  EN
 ---pagebreak---                                                Article 123
                           Dispatch of products of animal origin to the Union
   Consignments of products of animal origin shall only be permitted to enter the Union if such
   consignments have been dispatched to their destination in the Union separated from animals
   and products of animal origin not complying with the relevant animal health requirements for
   entry into the Union provided for in this Regulation.
                                               TITLE 2
     ANIMAL HEALTH REQUIREMENTS FOR ENTRY INTO THE
                                 UNION OF FRESH MEAT
                                             Chapter 1
               General animal health requirements for fresh meat
                                               Article 124
                Dispatch of kept animals of origin of the fresh meat to a slaughterhouse
   Consignments of fresh meat of kept animals, except those kept as farmed game that have been
   killed on-the-spot, shall only be permitted to enter the Union if the fresh meat of the
   consignment has been obtained from kept animals which comply with the following
   requirements:
   (a)      the establishment of origin of the animals is located, either:
            (i)    in the same third country or territory or zone thereof as the slaughterhouse
                   where the fresh meat was obtained;
                   or
            (ii)   in a third country or territory or zone thereof which at the time of dispatch of
                   the animals to the slaughterhouse was authorised to enter fresh meat of the
                   relevant species of animals to the Union.
   (b)      the kept animals were dispatched directly from their establishment of origin to the
            slaughterhouse;
   (c)      during the transport to the slaughterhouse referred to in point (a), the kept animals:
            (i)    did not pass through a third country or territory or zone thereof not listed for
                   entry into the Union of the particular species and category of fresh meat;
            (ii)   did not come into contact with animals of a lower health status.
   (d)      the means of transport and containers used to transport the kept animals to the
            slaughterhouse referred to in point (a) comply with the requirements laid down in
            Articles 17 and 18.
                                               Article 125
       Dispatch of carcasses of wild animals or animals kept as farmed game killed on the spot
   Consignments of fresh meat of wild animals or animals kept as farmed game that have been
   killed on-the-spot shall only be permitted to enter the Union if the fresh meat of the
   consignment has been obtained from carcasses which comply with the following
   requirements:
EN                                                  95                                              EN
 ---pagebreak---    (a)      the carcasses were dispatched directly from the place of killing to a game handling
            establishment situated in the same listed third country or territory or zone;
   (b)      during the transport to the game handling establishment referred to in point (a), the
            carcasses:
            (i)    did not pass through a third country or territory or zone thereof not listed for
                   entry into the Union of the particular species and category of fresh meat;
            (ii)   did not come into contact with animals or carcasses of a lower health status.
   (c)      the carcasses were transported to the game handling establishment referred to in
            point (a) in means of transport and containers which comply with the following
            requirements:
            (i)    they were cleaned and disinfected, with a disinfectant authorised by the
                   competent authority of the third country or territory of origin, before the
                   loading of the carcasses for dispatch to the Union;
            (ii)   they were constructed in such a way that the health status of the carcasses was
                   not jeopardised during the transport.
                                               Article 126
                             The ante-mortem and post-mortem inspections
   Consignments of fresh meat of kept and wild animals shall only be permitted to enter the
   Union if the fresh meat of the consignment has been obtained from animals which have
   undergone the following inspections:
   (a)      in the case of kept animals:
            (i)    an ante-mortem inspection within the period of 24 hours prior to the time of
                   slaughter;
            (ii)   a post-mortem inspection carried out, without delay, after their killing or
                   slaughter.
   (b)      in the case of wild animals, a post-mortem inspection carried out, without delay, after
            their killing.
   The inspections referred to in the first paragraph must have been carried out by an official
   veterinarian in the third country or territory of origin or zone thereof in order to exclude the
   presence of the relevant diseases referred to in Annex I and of emerging diseases.
                                               Article 127
           Handling of the animals of origin of the fresh meat during killing or slaughter
   Consignments of fresh meat shall only be permitted to enter the Union if the fresh meat of the
   consignment originates from animals which had no contact with animals of a lower health
   status during their killing or slaughter.
                                               Article 128
       Handling and preparation of fresh meat in the establishment of origin of the fresh meat
   Consignments of fresh meat must be kept strictly segregated from fresh meat not complying
   with the relevant animal health requirements for entry into the Union of fresh meat, provided
   for in Articles 124 to 146, throughout the operations of slaughter, cutting and until either:
EN                                                 96                                               EN
 ---pagebreak---    (a)      it was packed for further storage or dispatch to the Union;
            or
   (b)      its arrival to the Union, in the case of unpacked fresh meat.
                                              Chapter 2
           Animal health requirements for fresh meat of ungulates
                                               SECTION 1
       GENERAL ANIMAL HEALTH REQUIREMENTS FOR FRESH MEAT OF KEPT AND
                                           WILD UNGULATES
                                                Article 129
                     The species of animals of origin of the fresh meat of ungulates
   Consignments of fresh meat from ungulates shall only be permitted to enter the Union if the
   fresh meat of the consignment originates from the following species:
   (a)      in the case of kept ungulates, from all species of ungulates;
   (b)      in the case of wild ungulates and ungulates kept as farmed game, from all species of
            ungulates except from bovine animals, ovine animals, caprine animals and domestic
            breeds of porcine animals
                                                Article 130
                             Prohibition as regards the entry of fresh blood
   Consignments of fresh blood of ungulates for human consumption shall not be permitted to
   enter the Union.
                                               SECTION 2
          SPECIFIC ANIMAL HEALTH REQUIREMENTS FOR FRESH MEAT OF KEPT
                                              UNGULATES
                                                Article 131
     The residency period prior to slaughter or killing of the kept ungulates of origin of the fresh
                                                   meat
   1.       The kept ungulates of origin of the fresh meat intended for entry into the Union shall
            not be required to comply with a residency period prior to the date of slaughter or
            killing provided that they were introduced into the third country or territory or zone
            thereof from:
            (a)    another third country or territory or zone which is listed for entry into the
                   Union of fresh meat from the same species of ungulates and the kept ungulates
                   remained there for at least 3 months prior to slaughter;
                   or
            (b)    a Member State.
   2.       The kept ungulates of origin of the fresh meat intended for entry into the Union other
            than those referred to in paragraph 1, must comply, immediately prior to the date of
EN                                                  97                                               EN
 ---pagebreak---             slaughter or killing, with a residency period for a continuous period of time in
            accordance with Annex XXIII where they:
            (a)    remained in the third country or territory of origin or zone thereof;
            (b)    remained in the establishment of origin;
            (c)    had no contact with ungulates of a lower health status.
                                               Article 132
         Derogation from direct dispatch of the kept animals of origin of the fresh meat to a
                                             slaughterhouse
   By way of derogation from Article 124(b), consignments of fresh meat of kept ungulates not
   complying with those requirements shall be permitted to enter the Union provided that the
   fresh meat of the consignment was obtained from bovine animals, ovine animals or caprine
   animals, and:
   (a)      the ungulates passed through one single establishment conducting assembly
            operations, which complies with the requirements laid down in Article 20(b), after
            leaving their establishment of origin and prior to their arrival at the slaughterhouse;
   (b)      the competent authority of the third country or territory of origin has provided
            additional guarantees to ensure the animal health status of the ungulates during their
            movement from their establishment of origin to their arrival at the slaughterhouse has
            not been jeopardised;
   (c)      the third country, territory or zone thereof referred to in point (b) is authorised in the
            list for such derogation.
                                               Article 133
      The third country or territory of origin or zone thereof of the fresh meat of kept ungulates
   1.       Consignments of fresh meat of kept ungulates shall only be permitted to enter the
            Union if the fresh meat of the consignment originates from a third country or
            territory or zone thereof which complies with the minimum periods of disease
            freedom set out in the table in Part A of Annex XXIV, for the referred listed
            diseases, for which the species of ungulates from which the fresh meat has been
            obtained are listed.
            The minimum periods referred to in the first subparagraph may be reduced for the
            diseases listed in Part B of Annex XXIV subject to compliance with the specific
            conditions provided for therein; these specific conditions must be specifically
            assigned by the Union in the list, to that third country or territory or zone thereof and
            to the particular species of origin of the fresh meat.
   2.       Consignments of fresh meat of ungulates shall only be permitted to enter the Union if
            the fresh meat of the consignment originates from a third country or territory or zone
            thereof in which vaccination against listed diseases referred to in paragraph 1 has not
            been carried out according to the table in Part A of Annex XXV.
   3.       By way of derogation of paragraph 2, vaccination against foot and mouth disease
            may have been carried out subject to compliance with the specific conditions to be
            provided by the competent authority set out in points 1(b) or 3.1(a) of Part B of
            Annex XXV which must be specifically assigned by the Union in the list, to that
EN                                                  98                                                 EN
 ---pagebreak---              third country or territory or zone thereof and to the particular species of origin of the
             fresh meat.
                                                Article 134
   The establishment of origin of the kept ungulates from which the fresh meat has been obtained
   1.        Consignments of fresh meat of kept ungulates shall only be permitted to enter the
             Union if the fresh meat of the consignment has been obtained from ungulates which
             come from an establishment:
             (a)   in and around which, including where appropriate the territory of a
                   neighbouring country, none of the listed diseases referred to in Part A of Annex
                   XXIV, for which the species of ungulates of origin of the fresh meat intended
                   for entry into the Union are listed, has been reported in an area of 10 km radius
                   and for a period of 30 days prior to the date of slaughter; or
             (b)   which complies with the specific conditions to be provided by the competent
                   authorities where vaccination against foot and mouth disease has been carried
                   out in the third country or territory or zone thereof less than 12 months prior to
                   the date of slaughter set out in points 1(b) or 3.1(a) of Part B of Annex XXV
                   which must have been specifically assigned by the Commission in the list to
                   the third country or territory or zone thereof authorised for entry into the Union
                   of fresh meat of ungulates and to the species of origin of the fresh meat.
   2.        Consignments of fresh meat of kept ungulates shall only be permitted to enter the
             Union if the fresh meat of the consignment has been obtained from ungulates which
             come from an establishment:
             (a)   where no animals have been vaccinated according to Part A of Annex XXV; or
             (b)   which is located in a third country, territory or zone thereof which complies
                   with the specific conditions set out in point 1 of Part B of Annex XXIV; these
                   conditions must have been specifically assigned by the Commission in the list
                   to the third country or territory or zone thereof listed for entry into the Union of
                   fresh meat of ungulates and to the species of origin of the fresh meat.
                                                Article 135
      Specific requirement for fresh meat obtained from kept ungulates of the species Sus scrofa
   Consignments of fresh meat of kept ungulates of the species Sus scrofa shall only be
   permitted to enter the Union if the fresh meat of the consignment originates from animals
   which have been kept separated from wild ungulates since birth.
                                                Article 136
                    The establishment of origin of the fresh meat of kept ungulates
   Consignments of fresh meat of kept ungulates shall only be permitted to enter the Union if the
   fresh meat of the consignment was obtained in a slaughterhouse, or in a game handling
   establishment, in and around which none of the listed diseases referred to in Part A of Annex
   XXIV has been reported in an area of 10 km radius, including, where appropriate, the territory
   of a neighbouring country, for a period of 30 days prior to the date of slaughter or to the date
   of killing.
EN                                                   99                                                 EN
 ---pagebreak---                                               SECTION 3
         SPECIFIC ANIMAL HEALTH REQUIREMENTS FOR FRESH MEAT OF WILD
                                              UNGULATES
                                               Article 137
        The country or territory of origin or zone thereof of the fresh meat of wild ungulates
   Consignments of fresh meat of wild ungulates shall only be permitted to enter the Union if the
   fresh meat of the consignment originates from a third country or territory or zone thereof
   which complies with the animal health requirements laid down in Article 133.
                                               Article 138
                             The wild ungulates of origin of the fresh meat
   Consignments of fresh meat of wild ungulates shall only be permitted to enter the Union if the
   fresh meat of the consignment was obtained from animals which comply with the following
   requirements:
   (a)      they were killed at a distance that exceeds 20 km from the border of any third
            country or territory or zone thereof which at that time was not listed for entry into the
            Union of fresh meat of the species of wild ungulates;
   (b)      they were killed in an area of 20 km radius, where, during the preceding 60 days, the
            diseases referred to in Part A of Annex XXIV have not been reported.
                                               Article 139
             The game handling establishment of origin of fresh meat of wild ungulates
   Consignments of fresh meat of wild ungulates shall only be permitted to enter the Union if the
   fresh meat of the consignment has been obtained in a game handling establishment in and
   around which none of the listed diseases referred to in Part A of Annex XXIV has been
   reported in an area of 10 km radius, including where appropriate the territory of a
   neighbouring country, for a period of 30 days prior to the date of killing.
                                              Chapter 3
     Animal health requirements for fresh meat of poultry and game
                                                 birds
                                              SECTION 1
       SPECIFIC ANIMAL HEALTH REQUIREMENTS FOR FRESH MEAT OF POULTRY
                                               Article 140
                                     The residency period of poultry
   Consignments of fresh meat of poultry shall only be permitted to enter the Union if the fresh
   meat of the consignment has been obtained from poultry which:
   (a)      have been kept since hatching and until the date of slaughter in the third country or
            territory of origin of the fresh meat or zone thereof;
            or
EN                                                 100                                                EN
 ---pagebreak---    (b)     were imported as day-old chicks, breeding poultry, productive poultry or poultry
           intended for slaughter from a third country or territory or zone thereof which is listed
           for entry into the Union for those commodities or from a Member State and the
           import took place in accordance with animal health requirements at least as stringent
           as the relevant requirements of this Regulation.
                                              Article 141
        The third country or territory of origin or zone thereof of the fresh meat of poultry
   Consignments of fresh meat of poultry shall only be permitted to enter the Union if the fresh
   meat of the consignment originates 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 carried 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 fresh meat of poultry other than ratites, it is considered to be free
                  from infection with Newcastle disease virus in accordance with Article 39;
           (ii)   in the case of fresh meat of ratites, is either:
                  –     considered to be free from infection with Newcastle disease virus in
                        accordance with Article 39;
                        or
                  –     not considered to be 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
EN                                                101                                                  EN
 ---pagebreak---                           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 from which the fresh meat has been obtained meet the animal health
                   requirements set out in point 3 of Annex XV for fresh meat of poultry
                   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 an 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 of 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 142
                                 The establishment of origin of the poultry
   Consignments of fresh meat of poultry shall only be permitted to enter the Union if the fresh
   meat of the consignment originates from poultry which come from an establishment:
   (a)      in which and within a 10 km radius of the establishment, 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 slaughter;
   (b)      which, in the case of fresh meat of ratites originating in a third country or territory or
            zone thereof not free from infection with Newcastle disease virus, complies with the
            animal health requirements for ratites, hatching eggs thereof and fresh meat of ratites
            originating in a third country or territory or zone thereof not free from infection with
            Newcastle disease virus, set out in points 3(b) and (c) of Annex XIV.
                                                 Article 143
                                  The poultry of origin of the fresh meat
   1.       Consignments of fresh meat of poultry shall only be permitted to enter the Union if
            the fresh meat of the consignment has been obtained from poultry which have not
            been vaccinated against highly pathogenic avian influenza or infection with
            Newcastle disease virus, or they comply with the following requirements:
EN                                                   102                                                EN
 ---pagebreak---             (a)    where they have been vaccinated against highly pathogenic avian influenza,
                   guarantees for compliance with the minimum requirements for vaccination
                   programmes and additional surveillance set out in Annex XIII, have been
                   provided by the third country or territory of origin;
            (b)    where 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 general criteria for recognised vaccines against infection with
                                Newcastle disease virus set out in point 1 of Annex XV and the
                                poultry from which the fresh meat has been obtained meet the
                                animal health requirements set out in point 3 of Annex XV for
                                fresh meat of poultry 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.
   2.       Consignments of fresh meat of poultry which is destined to a Member State or
            territory with status free from infection with Newcastle disease virus without
            vaccination, shall only be permitted to enter the Union if the fresh meat of the
            consignment originates from poultry which have not been vaccinated against
            Newcastle disease with a live vaccine during the period of 30 days prior to the date
            of slaughter.
                                                Article 144
                        The establishment of origin for the fresh meat of poultry
   Consignments of fresh meat of poultry shall only be permitted to enter the Union if the fresh
   meat of the consignment originates from a slaughterhouse which:
   (a)      at the time of slaughter, was not under restrictions due to an outbreak of highly
            pathogenic avian influenza or infection with Newcastle disease virus or under official
            restrictions under national legislation for animal health reasons;
   (b)      within a 10 km radius of the slaughterhouse, 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 slaughter.
EN                                                  103                                                EN
 ---pagebreak---                                               SECTION 2
     SPECIFIC ANIMAL HEALTH REQUIREMENTS FOR FRESH MEAT OF GAME BIRDS
                                               Article 145
       The third country or territory of origin or zone thereof of the fresh meat of game birds
   Consignments of fresh meat of game birds shall only be permitted to enter the Union if the
   fresh meat of the consignment originates 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 established 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)      where there have been no animal health restrictions due to an outbreak of highly
            pathogenic avian influenza or infection with Newcastle disease virus during the
            period of at least 30 days prior to the time of killing.
                                               Article 146
                      The establishment of origin of the fresh meat of game birds
   Consignments of fresh meat of game birds shall only be permitted to enter the Union if the
   fresh meat of the consignment originates from a game handling establishment:
   (a)      which, at the time of dressing, was not under restrictions due to an outbreak of highly
            pathogenic avian influenza or infection with Newcastle disease virus or under official
            restrictions for animal health reasons;
   (b)      within a 10 km radius of the game handling establishment, 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 the 30 days prior to the date of reception of the carcasses.
                                              TITLE 3
       ANIMAL HEALTH REQUIREMENTS FOR ENTRY INTO
           THE UNION OF MEAT PRODUCTS AND CASINGS
                                               Article 147
                                       Treatment of meat products
   Consignments of meat products shall only be permitted to enter the Union if the meat
   products of the consignment have been treated in accordance with Article 121 as required in
   Articles 148 or 149.
EN                                                 104                                              EN
 ---pagebreak---                                              Article 148
                      Meat products not subject to a risk-mitigating treatment
   Consignments of meat products shall only be permitted to enter the Union if the meat
   products of the consignment have not undergone a risk-mitigating treatment in accordance
   with Annex XXVI where:
   (a)     the third country or territory of origin or zone thereof is listed for entry into the
           Union of fresh meat of the relevant species, and specific conditions in accordance
           with Chapter 1 and 2 of Title 1, Part IV, are not required for entry into the Union of
           such fresh meat;
   (b)     the fresh meat used for the processing of the meat product complied with all the
           requirements for entry into the Union of fresh meat and therefore was eligible for
           entry into the Union and originated from;
           (i)   the third country or territory or zone thereof where the meat product was
                 processed;
           (ii)  a third country or territory or zone thereof which is listed for entry into the
                 Union of fresh meat of the relevant species;
           (iii) a Member State.
                                             Article 149
                        Meat products subject to a risk-mitigating treatment
   1.      Consignments of meat products that do not fulfil the requirements provided for in
           Article 148, shall only be permitted to enter the Union if they have undergone at least
           the risk-mitigating treatment set out in Annex XXVI specifically assigned by the
           Union in the list to the third country or territory or zone thereof of origin of the meat
           product in accordance with Article 121, where the fresh meat used for processing of
           the meat products originates from:
           (a)   the third country or territory or zone thereof where the meat product has been
                 processed;
           (b)   a listed third country or territory or zone thereof authorised for entry into the
                 Union of fresh meat of the relevant species;
           (c)   a Member State.
   2.      Consignments of meat products shall only be permitted to enter the Union if they
           have undergone at least the risk-mitigating treatment ‘B’, in accordance with Annex
           XXVI, where the fresh meat used for the processing of the meat products originates
           from a third country or territory or zone thereof:
           (a)   other than the third country or territory or zone thereof in which the meat
                 product is obtained;
           (b)   which is also listed for entry into the Union of meat products of the relevant
                 species, subject to a risk-mitigating treatment specifically assigned by the
                 Union in the list, to that third country or territory or zone thereof and to the
                 relevant species, in accordance with Article 121.
   3.      Consignments of meat products processed from fresh meat of poultry shall only be
           permitted to enter the Union if they have undergone at least the risk-mitigating
           treatment ‘D’, in accordance with Annex XXVI, where the fresh meat used for the
EN                                               105                                                 EN
 ---pagebreak---              processing of the meat products originates from a third country or territory or zone
             thereof:
             (a)   listed for entry into the Union of fresh meat of poultry;
             (b)   in which there has been a case or an outbreak of highly pathogenic avian
                   influenza or infection with Newcastle disease virus.
   4.        Consignments of meat products which have been processed from fresh meat of more
             than one species of animal from the third country or territory or zone thereof where
             the meat product was processed, shall only be permitted to enter the Union if they
             comply with the following requirements:
             (a)   the meat products must have undergone the most severe of the risk-mitigating
                   treatments assigned in the list to the third country or territory or zone thereof,
                   in accordance with Article 121, for the different species of animals of origin,
                   where the fresh meat is mixed before the final processing of the meat product
                   takes place; or
             (b)   the meat products must have undergone the risk-mitigating treatment assigned
                   in the list to the third country or territory or zone thereof, in accordance with
                   Article 121, for each different species of animals of origin, where the mixing of
                   the meat products have taken place after processing of each ingredient of the
                   meat product.
   5.        Consignments of meat products which have been processed from fresh meat of more
             than one species of animal originating from a third country or territory or zone
             thereof other than the third country or territory or zone thereof where the meat
             product has been processed, shall only be permitted to enter the Union if they have
             undergone a risk-mitigating treatment in accordance with paragraphs 1 or 2.
                                                Article 150
          The establishment of origin of the animals from which the fresh meat was obtained
   Consignments of meat products shall only be permitted to enter the Union if they that have
   been processed from fresh meat which originate from animals coming from an establishment,
   or, in the case of wild animals, from a place in and around which, in an area of 10 km radius,
   including where appropriate the territory of a neighbouring country, none of the listed
   diseases, relevant for the species of origin of the meat products in accordance with Annex I,
   has been reported during the period of 30 days prior to the date of dispatch of the consignment
   to the Union.
                                                Article 151
      The entry into Member States with status free from infection with Newcastle disease virus
                                            without vaccination
   Consignments of meat products of poultry intended for a Member State or territory thereof
   with a status free from infection with Newcastle disease virus without vaccination shall only
   be permitted to enter into the Union if they have obtained from poultry which have not been
   vaccinated with a live vaccine against infection with Newcastle disease virus, during the
   period of 30 days prior to the date of slaughter.
EN                                                  106                                               EN
 ---pagebreak---                                               Article 152
                       Specific requirements for entry into the Union of casings
   Consignments of casings that do not fulfil the requirements provided for in Article 148 shall
   only be permitted to enter the Union if they have undergone the following risk-mitigating
   treatments set out in Part 2 of Annex XXVI:
   (a)      treatments ‘Casing 1’ or ’ Casing 2’, where the bladders and intestines used for the
            processing of the casings originate from bovine animals, ovine animals, caprine
            animals or kept porcine animals;
   (b)      treatments ‘Casing 3’, ‘Casing 4’ or ‘Casing 5’ where the bladders and intestines
            used for the processing of the casings originate from animals of species other than
            those referred to in point (a).
                                              TITLE 4
      ANIMAL HEALTH REQUIREMENTS FOR ENTRY INTO THE
        UNION OF MILK, DAIRY PRODUCTS, COLOSTRUM AND
                          COLOSTRUM-BASED PRODUCTS
                                             Chapter 1
    Specific animal health requirements for raw milk, colostrum and
                                  colostrum based products
                                              Article 153
           The country of origin of the raw milk, colostrum and colostrum-based products
   Consignments of raw milk, colostrum or colostrum-based products shall only be permitted to
   enter the Union if the raw milk, colostrum and colostrum-based products of the consignment
   originate from a third country or territory or zone thereof which has been free from foot and
   mouth disease and infection with rinderpest virus for a period of at least 12 months prior to
   the date of milking and, during that period, no vaccination against those diseases has been
   carried out.
                                              Article 154
           The animals of origin of the raw milk, colostrum and colostrum-based products
   1.       Consignments of raw milk, colostrum or colostrum based products shall only be
            permitted to enter the Union if the raw milk, colostrum or colostrum-based products
            of the consignment were obtained from animals of the species Bos taurus, Ovis aries,
            Capra hircus, Bubalus bubalis or Camelus dromedarius.
   2.       Consignments of raw milk, colostrum or colostrum based products shall only be
            permitted to enter the Union if the raw milk, colostrum or colostrum based products
            of the consignment were obtained from animals that complied with a continuous
            residency period of at least 3 months prior to the date of milking in the third country
            or territory of milking or zone thereof.
EN                                                107                                               EN
 ---pagebreak---                                              Chapter 2
          Specific animal health requirements for dairy products
                                              Article 155
                                     Treatment of dairy products
   Consignments of dairy products shall only be permitted to enter the Union if the dairy
   products of the consignment have been treated in accordance with Article 156 or 157.
                                              Article 156
                       Dairy products not subject to a risk-mitigating treatment
   Consignments of dairy products originating from a third country or territory or zone thereof
   which is listed for entry into the Union of raw milk shall be permitted to enter the Union
   without having undergone a specific risk-mitigating treatment if the dairy products of the
   consignment comply with following requirements:
   (a)     the raw milk from which they were processed was obtained from animals of the
           species Bos taurus, Ovis aries, Capra hircus, Bubalus bubalis and Camelus
           dromedarius;
   (b)     the raw milk used for the processing of the dairy products complied with the relevant
           general requirements for entry into the Union laid down in Articles 3 to 10 and the
           specific requirements for entry into the Union of raw milk provided for in Article
           153 and Article 154, and therefore was eligible for entry into the Union and it
           originates from one of the following:
           (i)    the listed third country or territory or zone where the dairy products were
                  processed;
           (ii)   a third country or territory or zone thereof other than listed third country or
                  territory or zone thereof where the dairy products were processed and which is
                  authorised for entry into the Union of raw milk; or
           (iii) a Member State.
                                              Article 157
                         Dairy products subject to a risk-mitigating treatment
   1.      Consignments of dairy products not complying with the requirements set out in
           Article 156 shall only be permitted to enter the Union if the dairy products of the
           consignment have undergone at least one of the risk-mitigating treatments provided
           for in column A of Annex XXVII, where:
           (a)    they were processed from milk obtained from the species Bos Taurus, Ovis
                  aries, Capra hircus, Bubalus bubalis or Camelus dromedarius;
           (b)    the third country or territory of origin or zone thereof has not been free from
                  foot and mouth disease and infection with rinderpest virus for a period of at
                  least 12 months prior to the date of milking, or if during that period vaccination
                  against those diseases has been carried out.
   2.      Consignments of dairy products shall only be permitted to enter the Union if the
           dairy products of the consignment have undergone at least one of the risk-mitigating
           treatments provided for in column B of Annex XXVII where they were processed
EN                                                108                                                EN
 ---pagebreak---             from milk obtained from species of animals other than those referred to in paragraph
            1(a).
   3.       Consignments of dairy products that have been processed from raw milk or from
            dairy products obtained from more than one species of animal shall only be permitted
            to enter the Union if those dairy products have undergone either:
            (a)    at least the most severe of the risk-mitigating treatments assigned to the each
                   species of animals of origin, where the mixing of raw milk or dairy products
                   takes place before the final processing of the product; or
            (b)    the risk-mitigating treatment assigned to each species of animals of origin,
                   where the mixing of the products takes place after processing of each
                   ingredient of the dairy product.
                                              TITLE 5
      ANIMAL HEALTH REQUIREMENTS FOR ENTRY INTO THE
                      UNION OF EGGS AND EGG PRODUCTS
                                             Chapter 1
                    Specific animal health requirements for eggs
                                               Article 158
                  The third country or territory of origin or zone thereof of the eggs
   Consignments of eggs shall only be permitted to enter the Union if the eggs of the
   consignment originate from a third country or territory or zone thereof which applies a disease
   surveillance programme for highly pathogenic avian influenza that complies with the
   requirements established in either:
   (a)      Annex II to this Regulation;
            or
   (b)      the relevant Chapter of the Terrestrial Animal Health Code of the World
            Organisation for Animal Health (OIE).
                                               Article 159
                                 The establishment of origin of the eggs
   Consignments of eggs shall only be permitted to enter the Union if the eggs of the
   consignment originate from an establishment that complies with the following requirements:
   (a)      during the period of 30 days prior to the date of collection of the eggs and until the
            date of issue of the certificate for entry into the Union, no outbreak of highly
            pathogenic avian influenza or infection with Newcastle disease virus occurred; and
   (b)      within a 10 km radius of the establishment, including, where appropriate, the
            territory of a neighbouring country there was no outbreak of highly pathogenic avian
            influenza or infection with Newcastle disease virus for a period of at least 30 days
            prior to the date of collection of eggs and until the date of issue of the certificate for
            entry into the Union.
EN                                                 109                                                 EN
 ---pagebreak---                                               Chapter 2
             Specific animal health requirements for egg products
                                                Article 160
              The third country or territory of origin or zone thereof of the egg products
   Consignments of egg products shall only be permitted to enter the Union if the egg products
   of the consignment originate from a third country or territory or zone thereof which applies a
   disease surveillance programme for highly pathogenic avian influenza that complies with the
   requirements established in either:
   (a)      Annex II to this Regulation;
            or
   (b)      the relevant Chapter of the Terrestrial Animal Health Code of the World
            Organisation for Animal Health (OIE).
                                                Article 161
                                 The establishment of origin of the eggs
   Consignments of egg products shall only be permitted to enter the Union if the egg products
   of the consignment have been processed from eggs that originated in an establishment:
   (a)      in which, during the period of 30 days prior to the date of collection of the eggs, no
            outbreak of highly pathogenic avian influenza and infection with Newcastle disease
            virus has occurred;
   (b)      within a 10 km radius of the establishment, including, where appropriate, the
            territory of a neighbouring country, there has either been:
            (i)    no outbreak of highly pathogenic avian influenza for a period of at least 30
                   days prior to the date of collection of eggs; or
            (ii)   an outbreak of highly pathogenic avian influenza within the period of 30 days
                   prior to the date of collection of eggs and the egg product has undergone one of
                   the risk-mitigating treatments for egg products set out in point 1 of Annex
                   XXVIII.
   (c)      within a 10 km radius of the establishments, including, where appropriate, the
            territory of a neighbouring country, there has either been:
            (i)    no outbreak of infection with Newcastle disease virus for a period of at least 30
                   days prior to the date of collection of eggs; or
            (ii)   an outbreak of infection with Newcastle disease virus within the period of 30
                   days prior to the date of collection of eggs and the egg product, has undergone
                   one of the risk-mitigating treatments for egg products set out in point 2 of
                   Annex XXVIII.
EN                                                  110                                              EN
 ---pagebreak---                                               TITLE 6
      ANIMAL HEALTH REQUIREMENTS FOR ENTRY INTO THE
       UNION OF PROCESSED PRODUCTS OF ANIMAL ORIGIN
                    CONTAINED IN COMPOSITE PRODUCTS
                                              Article 162
       Composite products containing meat products and non-shelf stable composite products
                                 containing dairy and/or egg products
   1.      Consignments of the following composite products shall only be permitted to enter
           the Union if the composite products of the consignment come from a third country or
           territory or zone thereof listed for entry into the Union of the specific product of
           animal origin contained in those composite products:
           (a)    composite products containing meat products;
           (b)    composite products containing dairy products or egg products which have not
                  been processed to become shelf stable.
   2.      Consignments of composite products shall only be permitted to enter the Union if the
           processed products of animal origin contained in the composite products referred to
           in paragraph 1:
           (a)    comply with:
                  (i)   the relevant general animal health requirements for entry into the Union
                        of products of animal origin laid down in Part 1 of this Regulation;
                  (ii)  the animal health requirements for entry into the Union of the specific
                        product of animal origin, as laid down in Titles 3 to 5 of this Part.
           (b)    they have been obtained either:
                  (i)   in the same listed third country or territory of origin or zone thereof of
                        the composite product;
                  (ii)  in the Union; or
                  (iii) in a third country or territory or zone thereof listed for entry into the
                        Union of those products without undergoing a specific risk-mitigating
                        treatment, in accordance with Articles 148 and 156, if the third country
                        or territory or zone thereof where the composite product is produced is
                        also listed for entry into the Union of those products without the
                        obligation to apply a specific risk-mitigating treatment.
                                              Article 163
               Shelf stable composite products containing dairy and/or egg products
   Consignments of composite products containing only dairy or egg products shall only be
   permitted to enter the Union if the dairy products and the egg products contained in the
   composite products have been treated to become shelf stable at ambient temperature and they:
   (a)     have been subjected to a treatment, at least equivalent to the following treatments:
           (i)    risk-mitigating treatments for dairy products as set out in column B in Annex
                  XXVII;
EN                                                111                                              EN
 ---pagebreak---             (ii)   risk-mitigating treatments for egg products set out in Annex XXVIII;
   (b)      by way of derogation of point 1(c)(i) of Article 3, are accompanied by a declaration
            of the operator of the third country or territory of origin of the composite products,
            attesting that the dairy products and egg products contained in the composite
            products have undergone at least the risk-mitigating treatment provided for in point
            (a).
                                               TITLE 7
           SPECIAL RULES FOR ENTRY INTO THE UNION OF
    PRODUCTS OF ANIMAL ORIGIN INTENDED FOR PERSONAL
                                                  USE
                                               Article 164
    Derogation from animal health requirements and additional requirements for entry of infant
                      milk, infant food and special foods intended for personal use
   By way of derogation from the requirements laid down in Articles 3 to 10 of Part I and
   Articles 120 to 163, consignments of powdered infant milk, infant food and special foods
   required for medical reasons, containing products of animal origin which do not comply with
   those requirements shall be permitted to enter the Union if those products:
   (a)      are intended for personal use;
   (b)      do not exceed a combined quantity of 2 kilogramme per person;
   (c)      do not require refrigeration before opening;
   (d)      are packaged proprietary brand products for direct sale to the final consumer;
   (e)      maintain the packaging unbroken, unless in current use.
                                               Article 165
       Derogation from animal health requirements for products of animal origin intended for
         personal use originating from certain third countries or territories or zones thereof
   1.       By way of derogation from requirements laid down in Articles 3 to 10 of Part I,
            except point (a)(i) of Article 3, and Articles 120 to 163, consignments of products of
            animal origin which do not comply with those requirements shall be permitted to
            enter the Union if those products are intended for personal use and originate from
            third countries or territories listed for entry into the Union of specific quantities of
            products of animal origin intended for personal use based on specific agreements
            with the Union on trade in agricultural products.
   2.       The combined specific quantity allowed to enter the Union accompanying a person
            shall not exceed the maximum specified for the third country or territory in the list.
                                               PART V
     Animal health requirements for entry into the Union as referred
    to in Articles 3 and 5 of aquatic animals of listed species and their
     products of animal origin, and for their movement and handling
                                          after the entry
EN                                                 112                                               EN
 ---pagebreak---                                                  TITLE 1
     GENERAL ANIMAL HEALTH REQUIREMENTS FOR ENTRY
      INTO THE UNION OF THE AQUATIC ANIMALS REFERRED
                   TO IN ARTICLE 1(6) AND THEIR PRODUCTS
                                                  Article 166
                              Inspection of aquatic animals prior to dispatch
   Consignments of aquatic animals other than those referred to in points (d), (e) and (f) of
   Article 172 shall only be permitted to enter the Union if those aquatic animals have been
   subjected to a clinical inspection by an official veterinarian in the exporting third country or
   territory, zone or compartment thereof within a period of 72 hours prior to the time of loading
   for dispatch of the consignment to the Union for the purpose of detection of symptoms of
   disease and abnormal mortalities.
                                                  Article 167
                                 Dispatch to the Union of aquatic animals
   Consignments of aquatic animals shall only be permitted to enter the Union if the aquatic
   animals of the consignment comply with the following requirements:
   (a)       they were dispatched directly from their establishment of origin to the Union;
   (b)       they were not unloaded, moved to another means of transport or unloaded from their
             container when transported by air, sea, railway or by road, and the water in which
             they are transported was not changed, in a third country or territory, zone or
             compartment which is not listed for entry of the particular species and category of
             aquatic animals into the Union;
   (c)       they have not been transported under conditions that have jeopardised their health
             status, in particular:
             (i)    where relevant, they must have been loaded and transported in water which did
                    not alter their health status;
             (ii)   the means of transport and the containers must have been constructed in such a
                    way that the health status of the aquatic animals was not jeopardised during the
                    transport;
             (iii) the container or well boat must have been cleaned and disinfected, in
                    accordance with a protocol and with products approved by the competent
                    authority of the third country or territory of origin, prior to loading for dispatch
                    to the Union, which ensure that the health status of the aquatic animals is not
                    jeopardised during transport;
   (d)       from the time of loading at the establishment of origin until the time of arrival to the
             Union, they must not have been transported in the same water or container or well-
             boat together with aquatic animals which were of a lower health status or which were
             not intended for entry into the Union;
   (e)       where a water exchange is necessary in a third country, territory, zone or
             compartment which is listed for entry of the particular species and category of
             aquatic animals into the Union, it must not have jeopardised the health status of the
             animals being transported and it must have only occurred:
EN                                                    113                                                EN
 ---pagebreak---             (i)    in the case of transport on land, at water exchange points approved by the
                   competent authority of the third country or territory where the water exchange
                   takes place;
            (ii)   in the case of transport by well-boat, at a distance which is at least 10 km from
                   any aquaculture establishments which are located en-route from the place of
                   origin to the place of destination in the Union.
                                                 Article 168
                                 Transport by vessel of aquatic animals
   When dispatch to the Union of consignments of aquatic animals, includes transport by vessel
   or well-boat even for part of the journey, those consignments of aquatic animals transported in
   accordance with Article 167 shall only be permitted to enter the Union if the aquatic animals
   of the consignment are accompanied by a declaration, attached to the animal health certificate
   and signed by the master of the vessel on the day of arrival of the vessel at its port of
   destination, providing the following information:
   (a)      the port of departure in the third country or territory;
   (b)      the port of arrival in the Union;
   (c)      the ports of call, in the case the vessel called at ports outside the third country or
            territory of origin or zone thereof;
   (d)      confirmation of compliance of the consignment of aquatic animals with the relevant
            requirements set out in Article 167 throughout the journey from the port of departure
            in the third country or territory to the port of arrival in the Union.
                                                 Article 169
                              Specific transport and labelling requirements
   1.       Consignments of aquatic animals shall only be permitted to enter the Union if the
            aquatic animals of the consignment are identified by a legible label on the exterior of
            the container, or when transported by well-boat, an entry in the vessel's manifest
            which refers to the animal health certificate that has been issued for that
            consignment.
   2.       The legible label referred to in paragraph 1 shall also contain at least the following
            information:
            (a)    the number of containers in the consignment;
            (b)    the name of the species present in each container;
            (c)    the number of animals in each container for each of the species present;
            (d)    the purpose for which they are intended;
   3.       Products of animal origin from aquatic animals other than live aquatic animals,
            intended for entry into the Union shall comply with the following requirements:
            (a)    they must be identified by a legible label on the exterior of the container, which
                   refers to the certificate that has been issued for that consignment;
            (b)    the legible label referred to in point (a) must also contain the following
                   statements, as relevant:
                   (i)   fish intended for human consumption in the European Union;
EN                                                   114                                              EN
 ---pagebreak---                  (ii)   molluscs intended for human consumption in the European Union;
                 (iii) crustaceans intended for human consumption in the European Union.
                                               Article 170
      Requirements regarding the third country or territory of origin or zone or compartment
                                thereof and the establishment of origin
   1.      Consignments of aquatic animals and products of animal origin from aquatic animals
           other than live aquatic animals shall only be permitted to enter the Union if the
           aquatic animals and products of animal origin of the consignment come from a third
           country or territory or zone or compartment thereof which complies with the
           following requirements:
           (a)   it must be free from the following listed diseases:
                 (i)    category A diseases and category B diseases of aquatic animals;
                 (ii)   relevant category C diseases when the aquatic animals or products of
                        animal origin are destined for Member States, zones or compartments
                        which have disease-free status or an approved eradication programme for
                        the specific diseases;
                 (iii) category C diseases in all cases when the aquatic animals are intended for
                        release into the wild;
                 (iv) where Member States of destination have taken national measures
                        referred to in Article 176 of this Regulation, aquatic animals of the
                        species listed in Annex XXIX must also originate from third countries,
                        territories, zones or compartments that are free from the diseases referred
                        to in that Annex;
           (b)   all the entries of aquatic animals of listed species into the third country or
                 territory, zone or compartment exporting to the Union must originate from a
                 different third country or territory or zone or compartment thereof which is free
                 from the diseases referred to in point (a);
           (c)   vaccination of aquatic animals of listed species against category A diseases,
                 category B or where relevant category C diseases, has not been carried out in
                 the third country or territory of origin.
   2.      Consignments of aquaculture animals and products of animal origin from
           aquaculture animals other than live aquaculture animals, shall only be permitted to
           enter the Union if the aquaculture animals and products of animal origin of the
           consignment come from an establishment which is:
           (a)   registered in accordance with requirements which are at least as stringent as to
                 those laid down in Section 1 of Chapter 1, Title II of Part IV of Regulation
                 (EU) 2016/429;
                 or
           (b)   approved in accordance with requirements which are at least as stringent as to
                 those laid down in Section 2 of Chapter 1, Title II of Part IV of Regulation
                 (EU) 2016/429 and Title I of Part II of Commission Delegated Regulation (EU)
                 2019/xxx as regards rules for aquaculture establishments and transporters of
                 aquatic animals [SANTE/7208/2019].
EN                                                 115                                              EN
 ---pagebreak---                                                Article 171
                                              Vector species
   1.       Aquatic animals of the species listed in column 4 of the table in the Annex to
            Commission Implementing Regulation (EU) 2018/1882, shall only be regarded as
            vectors of those diseases under the conditions set out in Annex XXX.
   2.       Products of animal origin from aquatic animals other than live aquatic animals of the
            species listed in column 4 of the table in the Annex to Commission Implementing
            Regulation (EU) 2018/1882, shall not be regarded as vectors of the diseases listed in
            that Annex when they enter the Union.
                                               Article 172
                 Derogations for certain categories of aquatic animals of listed species
   By way of derogation from Article 170, the requirements laid down in that Article shall not
   apply to the following categories of aquatic animals:
   (a)      aquatic animals which are destined for a disease control aquatic food establishment
            where they are to be processed for human consumption;
   (b)      aquatic animals intended for research purposes which are destined for confined
            establishments which have been approved for that purpose by the competent
            authority of the Member State of destination;
   (c)      wild aquatic animals other than those referred to in point (b) of this Article provided
            that they have been subject to quarantine in a quarantine establishment which has
            been approved for that purpose by the competent authority in:
            (i)    the third country of origin; or
            (ii)   the Union;
   (d)      molluscs or crustacea which are packed and labelled for human consumption in
            accordance with Regulation (EC) No. 853/2004 and which are no longer able to
            survive as living animals if returned to the aquatic environment;
   (e)      molluscs or crustacea which are packaged and labelled for human consumption in
            accordance with Regulation (EC) No. 853/2004 and which are intended for further
            processing without temporary storage at the place of processing;
   (f)      live bivalve molluscs or crustacea which are intended for human consumption
            without further processing, provided that they are packaged for retail sale in
            compliance with the provisions of Regulation (EC) No 853/2004.
                                               Article 173
       Derogations for certain products of animal origin from aquatic animals other than live
                                             aquatic animals
   By way of derogation from Article 170(1), the requirements laid down in that Article shall not
   apply to the following products of animal origin from aquatic animals, other than live aquatic
   animals:
   (a)      products of animal origin from aquatic animals, other than live aquatic animals,
            which are destined for a disease control aquatic food establishment where they are to
            be processed for human consumption;
EN                                                 116                                              EN
 ---pagebreak---    (b)      fish intended for human consumption which were slaughtered and eviscerated prior
            to dispatch to the Union.
                                               Article 174
    Handling of aquatic animals and products of animal origin from aquatic animals other than
                            live aquatic animals after entry into the Union
   1.       After their entry into the Union, consignments of aquatic animals and products of
            animal origin from aquatic animals other than live aquatic animals must be:
            (a)    transported directly to the place of destination in the Union;
            (b)    handled appropriately to ensure that natural waters are not contaminated.
   2.       Aquatic animals and products of animal origin from aquatic animals other than live
            aquatic animals which have entered the Union shall not be released by the operator
            or otherwise immersed in natural waters within the Union, unless authorised by the
            competent authority of the Member State in which that release or immersion takes
            place.
   3.       The competent authority of the Member State may only grant the authorisation
            referred to in paragraph 2 of this Article where the release or immersion in natural
            waters does not jeopardise the health status of the aquatic animals at the place of
            release and in all cases, release into the wild shall comply with Article 170(a)(iii).
   4.       Transport water from consignments of aquatic animals shall be handled appropriately
            by the operator to prevent contamination of natural waters in the Union.
                                                TITLE 2
    ANIMAL HEALTH REQUIREMENTS TO LIMIT THE IMPACT OF CERTAIN
                                     NON-LISTED DISEASES
                                               Article 175
      Additional animal health requirements to limit the impact of non-listed diseases for which
                                Member States have national measures
   1.       The competent authority of Member States that have taken national measures against
            diseases other than listed diseases as provided for in Article 226 of Regulation (EU)
            2016/429, shall take measures to prevent the introduction of those non-listed diseases
            through the application of additional animal health requirements for entry of the
            aquatic animals and products of animal origin from aquatic animals other than live
            aquatic animals into those Member States, zones or compartments of the Union.
   2.       The competent authority referred to in paragraph 1 shall only permit the entry into
            their Member State of consignments of aquatic animals of species which are
            susceptible to the diseases referred to in paragraph 1 when vaccination against those
            diseases has not been carried out in the third country or territory of origin.
   3.       The competent authority referred to in paragraph 1 shall ensure that aquatic animals
            of the species referred to in paragraph 2 which are introduced into a third country or
            territory of origin or zone or compartment thereof shall originate from another third
            country, zone or compartment which is also free of the relevant disease.
   4.       The derogations provided for in Articles 172 and 173 shall apply to those aquatic
            animals and products of animal origin from aquatic animals which are referred to in
EN                                                  117                                            EN
 ---pagebreak---           paragraph 2 and which are destined for Member States which have national measures
          against the diseases referred to in paragraph 1 of this Article .
   5.     Handling after entry into the Union of the aquatic animals referred to in paragraph 2
          of this Article and products from those animals, shall comply with the conditions set
          out in Article 174.
                                              Part VI
      Special rules for entry of certain commodities as referred to in
      Articles 3 and 5 for which the Union is not the final destination
        and for entry of certain commodities originating from and
                                    returning to the Union
                                              Article 176
                             Requirements for transit through the Union
   1.     Consignments of animals, germinal products and products of animal origin falling
          within the scope of this Regulation not originating from but transiting through the
          Union and intended for a destination outside the Union shall only be permitted to
          transit through the Union if, either:
          (a)    they comply with all the relevant requirements for entry into the Union of the
                 particular species and category of animals, germinal products or products of
                 animal origin in question laid down in Parts I to V; or
          (b)    they fall within the scope of specific conditions, specifically assigned by the
                 Union in the list to the listed third country or territory or zone of origin and to
                 the particular species and category of animals, germinal products and products
                 of animal origin, to mitigate any potential animal health risk involved in such
                 movements.
   2.     Consignments of animals, germinal products and products of animal origin falling
          within the scope of this Regulation originating and returning to the Union after
          transiting through a third country or territory or zone thereof shall only be permitted
          to re-enter the Union if they comply with all the relevant requirements for the
          particular category of animals, germinal products or products of animal origin in
          question for entry into the Union laid down in Parts I to V, unless they fall within the
          scope of either:
          (a)    the additional requirements laid down in Articles 177 to 182;
                 or
          (b)    specific conditions, specifically assigned by the Union in the list to the listed
                 third country or territory or zone of transit and to the particular species and
                 category of animals, germinal products and products of animal origin, to
                 mitigate any potential animal health risk involved in such movements.
   3.     The specific conditions referred to in paragraph 1(b) and paragraph 2(b) shall be set
          out and assigned to the third country or territory of or zone thereof based on a risk
          assessment and taking into account the following:
          (a)    the criteria laid down in Article 230 of Regulation (EU) 2016/429;
EN                                                118                                                EN
 ---pagebreak---             (b)   the particular species and category of animals, germinal products and products
                  of animal origin intended for transit and the related animal health risks;
            (c)   geographical constraints;
            (d)   established trade routes;
            (e)   other relevant factors.
                                               Article 177
    Additional requirements for entry of registered horses originating from, and returning to the
    Union after temporary export to a third country or territory or zone thereof to participate in
                           competitions, races or equestrian cultural events
   1.       Consignments of registered horses temporarily exported from a Member State to
            third countries or territories or zones thereof listed for entry of equine animals into
            the Union shall be permitted to enter the Union provided they comply with the
            following additional requirements:
            (a)   they have been outside the Union for a period specified by the Commission for
                  the different purposes, not exceeding 90 days;;
            (b)   they have been kept in isolation in the third country or territory or zone thereof
                  except during races, competitions or cultural events, and the related activities
                  (including training, warm-up and presentation);
            (c)   they have been kept only in third countries or territories or zones thereof
                  belonging to the same sanitary group to which the third country or territory of
                  dispatch to the Union is assigned, in accordance with the specific requirements
                  of Part B of Annex XI, and they were moved into the third country or territory
                  or directly into the zone of dispatch under conditions at least as strict as if they
                  were moved directly to the Union.
   2.       By way of derogation from paragraph 1(c), the entry into the Union of registered
            horses after temporary export to third countries or territories or zones thereof
            belonging to more than one sanitary group shall be authorised for registered horses
            which have participated exclusively in specified high level competitions or races.
                                               Article 178
     Special requirements for entry of ungulates, poultry and aquatic animals originating from,
              and returning to the Union following a refusal of entry by a third country
   1.       Consignments of ungulates, poultry and aquatic animals originating from and
            returning to the Union following a refusal of entry by the competent authority of a
            third country or territory shall only be permitted to re-enter the Union if the
            following requirements are fulfilled:
            (a)   the refusing third country or territory is a third country or territory or zone
                  thereof listed for entry into the Union of the species and category of animals
                  which are returning;
            (b)   the animals referred to in point (a) did not transit through a third country or
                  territory or zone thereof other than those referred to in point (a);
            (c)   the animals are accompanied by the following documents:
EN                                                 119                                                 EN
 ---pagebreak---                   (i)   the original animal health certificate issued by the competent authority of
                        the Member State, or its electronic equivalents submitted in IMSOC, or
                        an authenticated copy of the official animal health certificate provided by
                        the competent authority of the Member State of origin;
                  (ii)  one of the following:
                        –      an official declaration of the competent authority or other public
                               authority of the third country or territory, indicating the reason for
                               the refusal and if applicable, confirming that the requirements of
                               point (d) have been complied with;
                               or
                        –      in the case of sealed consignments with an intact original seal, a
                               declaration by the operator responsible for the consignment
                               confirming that transport has taken place in accordance with point
                               d(ii) and where required point d(iii).
                  (iii) a declaration from the competent authority of the Member State of origin
                        that it agrees to accept the consignment and indicating the place of
                        destination for its return.
            (d)   where they have been unloaded in the third country or territory or zone thereof,
                  the competent authority of the third country or territory shall certify the
                  following:
                  (i)   it authorised and supervised the unloading of the animals directly to
                        facilities suitable for their isolation and temporary handling within the
                        premises of the border control post of the third country or territory;
                  (ii)  effective measures were put in place to avoid direct and indirect contact
                        between the animals of the consignment and any other animals;
                  (iii) where necessary, effective protection from vectors of relevant animal
                        diseases were provided for.
   2.       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.
                                               Article 179
    Special requirements for entry of animals other than ungulates, poultry and aquatic animals
   originating from, and returning to the Union following a refusal of entry by a third country or
                                                territory
   1.       Consignments of animals other than ungulates, poultry and aquatic animals
            originating from and returning to the Union following a refusal of entry by the
            competent authority of a third country or territory shall only be permitted to re-enter
            the Union if the animals of the consignment are accompanied by the following
            documents:
            (a)   the original animal health certificate issued by the competent authority of the
                  Member State of origin, or its electronic equivalents submitted in IMSOC, or
                  an authenticated copy of the official animal health certificate provided by the
                  competent authority of the Member State of origin;
            (b)   one of the following:
EN                                                  120                                               EN
 ---pagebreak---                   (i)    an official declaration of the competent authority or other public
                         authority of the third country or territory, indicating the reason for
                         refusal;
                         or
                  (ii)   in the case of sealed consignments or unopened containers, a declaration
                         by the operator responsible for the consignment indicating the reason for
                         refusal.
            (c)   a declaration from the competent authority of the Member State of origin that it
                  agrees to accept the consignment and indicating the place of destination for its
                  return.
   2.       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.
                                                Article 180
   Special requirements for entry of germinal products and packaged products of animal origin,
   originating from, and returning to the Union following a refusal of entry by a third country or
                                                 territory
   1.       Consignments of germinal products and packaged products of animal origin,
            originating from and returning to the Union following a refusal of entry by the
            competent authority of a third country or territory shall only be permitted to re-enter
            the Union if the following requirements are fulfilled:
            (a)   if the germinal products remain in the original container and the packaging of
                  the products of animal origin is intact;
            (b)   the germinal products and the products of animal origin are accompanied by:
                  (i)    the original animal health certificate issued by the competent authority of
                         the Member State of the place of origin , or its electronic equivalent
                         submitted in IMSOC, or an authenticated copy of the official animal
                         health certificate provided by the competent authority of the Member
                         State of origin;
                  (ii)   one of the following documents indicating the reason for refusal and if
                         applicable the place and date of unloading, storage and re-loading in the
                         third country or territory thereof and confirming that the requirements of
                         point (c) have been complied with:
                         –      a declaration of the competent authority or other public authority of
                                the third country or territory; or
                         –      in the case of containers with an intact original seal, a declaration
                                by the operator responsible for the consignment;
                  (iii) a declaration from the competent authority of a Member State that it
                         agrees to accept the consignment and indicating the place of destination
                         for its return;
            (c)   where the germinal products or products of animal origin referred to in points
                  (a) and (b) have been unloaded in the third country or territory thereof, the
                  competent authority of the third country or territory shall certify the following:
EN                                                  121                                               EN
 ---pagebreak---                    (i)   the germinal products or products of animal origin did not undergo any
                         other handling except unloading, storage and re-loading;
                   (ii)  effective measures were put in place to avoid the contamination of the
                         container where the germinal products are placed or the packaging of
                         products of animal origin with pathogens of listed diseases during the
                         unloading, storage and re-loading;
   2.       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.
                                               Article 181
         Special requirements for entry of unpackaged or in bulk products of animal origin,
      originating from, and returning to the Union following a refusal of entry by a listed third
                                           country or territory
   1.       Consignments of unpackaged or in bulk products of animal origin originating from
            and returning to the Union following a refusal of entry by the competent authority of
            a listed third country or territory shall only be permitted to re-enter the Union if the
            following requirements are fulfilled:
            (a)    the refusing third country or territory is listed for the entry into the Union of
                   the particular species and category of products of animal origin which are
                   being returned to the Union;
            (b)    the products of animal origin are accompanied by:
                   (i)   the original animal health certificate issued by the competent authority of
                         the Member State of origin, or its electronic equivalents submitted in
                         IMSOC, or an authenticated copy of the official certificate provided by
                         the competent authority of the Member State of origin;
                   (ii)  one of the following:
                         –      an official declaration of the competent authority or other public
                                authority of the third country or territory, indicating the reason for
                                refusal and confirming that the seal on the vehicle or container of
                                the consignment was only opened for official purposes and the
                                products were handled only to the smallest extent necessary for
                                those purposes and in particular without unloading them and the
                                vehicle or container was immediately re-sealed afterwards; or
                         –      in the case of sealed consignments, a declaration by the operator
                                responsible for the consignment indicating the reason for refusal;
                   (iii) a declaration from the competent authority of a Member State that it
                         agrees to accept the consignment and indicating the place of destination
                         for its return.
   2.       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.
                                               Article 182
         Special requirements for entry of unpackaged or in bulk products of animal origin,
EN                                                 122                                                 EN
 ---pagebreak---    originating from, and returning to, the Union following a refusal of entry by a non-listed third
                                                  country
   1.       Consignments of unpackaged or in bulk products of animal origin originating from
            and returning to the Union following a refusal of entry by the competent authority of
            a third country or territory which is not listed for entry into the Union of the
            particular species and category of products of animal origin which are being
            returned, shall only be permitted to re-enter the Union if the following requirements
            are fulfilled:
            (a)   the consignment is sealed with an intact original seal;
            (b)   the products of animal origin are accompanied by:
                  (i)    the original animal health certificate issued by the competent authority of
                         the Member State of origin, or its electronic equivalents submitted in
                         IMSOC, or an authenticated copy of the official animal health certificate
                         provided by the competent authority of the Member State of origin;
                  (ii)   one of the following:
                         –      an official declaration of the competent authority or other public
                                authority of the third country or territory, indicating the reason for
                                refusal; or
                         –      a declaration by the operator responsible for the consignment
                                indicating the reason for refusal;
                  (iii) a declaration from the competent authority of a Member State that they
                         agree to accept the consignment and indicating the place of destination
                         for its return.
   2.       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.
                                               Part VII
                                          Final provisions
                                                Article 183
                                                 Repeals
   The following acts are repealed as from 21 April 2021:
   –        Commission Regulation (EU) No 206/2010;
   –        Commission Implementing Regulation (EU) No 139/2013;
   –        Commission Regulation (EU) No 605/2010;
   –        Commission Regulation (EC) No 798/2008;
   –        Commission Decision 2007/777/EC;
   –        Commission Regulation (EC) No 119/2009;
   –        Commission Regulation (EU) No 28/2012;
   –        Commission Implementing Regulation (EU) 2016/759.
EN                                                  123                                                EN
 ---pagebreak---                                               Article 184
   This Regulation shall enter into force on the day following that of its publication in the
   Official Journal of the European Union.
   It shall apply from 21 April 2021.
   This Regulation shall be binding in its entirety and directly applicable in all Member States.
   Done at Brussels, 30.1.2020
                                                 For the Commission
                                                 The President
                                                 Ursula von der LEYEN
EN                                                124                                             EN
 ---documentbreak---                              EUROPEAN
                             COMMISSION
                                                     Brussels, 30.1.2020
                                                     C(2020) 416 final
                                                     ANNEXES 1 to 30
                                          ANNEXES
                                             to the
                  COMMISSION DELEGATED REGULATION (EU) .../...
      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 for animal
                                             origin
EN                                                                                        EN
 ---pagebreak---                                              ANNEX I
      LIST OF DISEASES REQUIRED TO BE NOTIFIED AND REPORTED IN THE
                     EXPORTING THIRD COUNTRY OR TERRITORY
   1.     TERRESTRIAL ANIMALS
          All the listed diseases referred to in Article 5 of Regulation (EU) 2016/429 and listed
          in Annex II thereto for the listed species of terrestrial animals in the Annex to
          Commission Implementing Regulation (EU) 2018/1882.
   2.     GERMINAL PRODUCTS
   2.1.   From ungulates
          –     Foot and mouth disease
          –     Infection with Brucella abortus, B. melitensis and B. suis
          –     Infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and
                M. tuberculosis)
          –     Infection with bluetongue virus (serotypes 1-24)
          –     Infection with epizootic haemorrhagic disease virus
          –     Infectious bovine rhinotracheitis / infectious pustular vulvovaginitis
          –     Bovine viral diarrhoea
          –     Bovine genital campylobacteriosis
          –     Trichomonosis
          –     Enzootic bovine leukosis
          –     Ovine epididymitis (Brucella ovis)
          –     Infection with equine arteritis virus
          –     Equine infectious anemia
          –     Contagious equine metritis
          –     Classical swine fever
          –     Infection with Aujeszky’s disease virus
          –     Infection with porcine reproductive and respiratory syndrome virus.
   2.2.   From poultry and captive birds
          All the listed diseases referred to in Article 5 of Regulation (EU) 2016/429 and listed
          in Annex II thereto that are relevant for the listed species of poultry and captive birds
          in the Annex to Commission Implementing Regulation (EU) 2018/1882, from which
          germinal products authorised to enter the Union are obtained.
EN                                                1                                                 EN
 ---pagebreak---    3.   PRODUCTS OF ANIMAL ORIGIN FROM UNGULATES, POULTRY AND WILD GAME BIRDS
   3.1. Fresh meat from ungulates
        –    Foot and mouth disease
        –    Infection with rinderpest virus
        –    Infection with Rift Valley fever virus
        –    Sheep pox and goat pox
        –    Peste des petits ruminants
        –    Classical swine fever
        –    African swine fever
   3.2. Fresh meat from poultry and wild game birds
        –    Highly pathogenic avian influenza
        –    Infection with Newcastle disease virus
   3.3. Meat products from ungulates
        –    Foot and mouth disease
        –    Infection with rinderpest virus
        –    Classical swine fever
        –    African swine fever
   3.4. Meat products from poultry and wild game birds
        –    Highly pathogenic avian influenza
        –    Infection with Newcastle disease virus
   3.5. Milk, colostrum, dairy products and colostrum-based products
        –    Foot and mouth disease
        –    Infection with rinderpest virus
   4.   AQUATIC ANIMALS AND PRODUCTS OF ANIMAL ORIGIN FROM AQUATIC ANIMALS
        –    Epizootic haematopoietic necrosis
        –    Viral haemorrhagic septicaemia
        –    Infectious haematopoietic necrosis
        –    Infection with highly polymorphic region (HPR) deleted infectious salmon
             anaemia virus
        –    Koi herpes virus
        –    Infection with Mikrocytos mackini
        –    Infection with Perkinsus marinus
        –    Infection with Bonamia ostreae
        –    Infection with Bonamia exitiosa
        –    Infection with Marteilia refringens
EN                                           2                                        EN
 ---pagebreak---    – Infection with Taura syndrome virus
   – Infection with yellow head virus
   – Infection with white spot syndrome virus.
EN                                   3         EN
 ---pagebreak---                                               ANNEX II
       MINIMUM INFORMATION FOR DISEASE SURVEILLANCE PROGRAMMES
                                     (referred to in Article 10)
   The submission of a disease surveillance programme must include at least the following
   information:
   (a)     a description of the epidemiological situation of the disease before the date the
           surveillance programme began to be implemented, and data on the epidemiological
           evolution of the disease;
   (b)     the targeted animal population, epidemiological units and zones of the surveillance
           programme;
   (c)     a description of:
           (i)    the organisation of the competent authority;
           (ii)   how the implementation of the surveillance programme is supervised;
           (iii) the official controls to be applied during the implementation of the programme;
           (iv) the role of all relevant operators, animal health professionals, veterinarians,
                  animal health laboratories and other natural or legal person concerned;
   (d)     a description and demarcation of the geographical and administrative areas in which
           the surveillance programme is to be implemented;
   (e)     the indicators to measure the progress of the programme;
   (f)     the diagnostic methods to be used, the number of samples to be tested, and the
           frequency of testing and sampling patterns;
   (g)     the risk factors to be considered for the design of risk-based targeted surveillance.
EN                                                 4                                             EN
 ---pagebreak---                                                                     ANNEX III
     Table 1. Requirements as regards the residency periods for ungulates, honeybees and bumblebees before their entry into the Union
                                   Minimum residency period in the                                             Minimum period without contact
                                                                         Minimum residency period in the
                                  third country or territory of origin                                          with animals of a lower health
  Species and category of animals                                       establishment of origin, as referred
                                     or zone thereof, as referred to                                            status as referred to in Article
                                                                                 to in Article 11(b)(ii)
                                            Article 11(b)(i)                                                               11(b)(iii)
                                     6 months or since birth, if the                                             30 days, or since birth, if the
     Bovine, ovine, caprine and                                        40 days, or since birth, if the animals
                                   animals are less than 6 months of                                           animals are less than 30 days of
           porcine animals                                                   are less than 40 days of age
                                                  age                                                                         age
     Bovine, ovine, caprine and      3 months, or since birth if the                                             30 days, or since birth, if the
                                                                       40 days, or since birth, if the animals
    porcine animals intended for   animals are less than 3 months of                                           animals are less than 30 days of
                                                                             are less than 40 days of age
              slaughter                           age                                                                         age
                                                                       30 days or since birth, if the animals
                                     3 months, or since birth if the
     Equine animals other than                                          are less than 30 days of age except
                                   animals are less than 3 months of                                                        15 days
     registered equine animals                                         for African horse sickness risk areas
                                                  age
                                                                         where the period shall be 40 days
                                                                       30 days or since birth, if the animals
                                      40 days or since birth if the          are less than 30 days of age,
     Registered equine animals      animals are less than 40 days of     except for African horse sickness                  15 days
                                                  age                   risk areas where the period shall be
                                                                                        40 days
                                             up to 30 days
   Registered horses re-entering
                                                   or
     after temporary export for                                                                                   During the entire period of
                                    up to 90 days in case of specific               Not established
   competition, races or cultural                                                                                      temporary export
          equestrian events          competitions, races or cultural
                                           equestrian events
EN                                                                         5                                                                     EN
 ---pagebreak---    Ungulates other than bovine,   6 months or since birth, if the                                           6 months or since birth, if the
                                                                  40 days, or since birth, if the animals
   ovine, caprine, porcine and  animals are less than 6 months of                                         animals are less than 6 months of
                                                                       are less than 40 days of age
         equine animals                        age                                                                       age
   Honeybees and bumblebees              Since hatching                       Since hatching                       Since hatching
EN                                                                   6                                                                      EN
 ---pagebreak---                 Table 2. Requirements as regards the residency periods of poultry and captive birds before their entry into the Union
                                   The     Minimum residency period in the Minimum residency period in         Minimum period without contact
                                residency third country or territory of origin the establishment of origin, as  with animals of a lower health
        Category of birds         period     or zone thereof, as referred to     referred to Article 11(b)(ii)  status as referred to in Article
                                 applies            Article 11(b)(i)                                                       11(b)(iii)
                                    to
                                           3 months or since hatching, if the   6 weeks, or since hatching, if 6 weeks, or since hatching, if the
        Breeding poultry           AC      animals are less than 3 months of     the animals are less than 6   animals are less than 6 weeks of
                                                           age                          weeks of age                          age
   Productive poultry for the              3 months, or since hatching, if the  6 weeks, or since hatching, if 6 week, or since hatching, if the
     production of meat and        AC      animals are less than 3 months of     the animals are less than 6   animals are less than 6 weeks of
      eggs for consumption                                 age                          weeks of age                          age
                                           6 weeks, or since hatching, if the
      Productive poultry for                animals are less than 6 weeks of                                      30 days, or since hatching
  restocking supplies of game      AC                      age                    30 days, or since hatching
              birds
                                           6 weeks, or since hatching, if the                                     30 days, or since hatching
       Poultry intended for                 animals are less than 6 weeks of
                                   AC                      age                    30 days, or since hatching
            slaughter
                                   AC               Since hatching                     Since hatching                   Since hatching
         Day-old chicks
                                   FO                  3 months                            6 weeks                             -
      Less than 20 breeding
                                           3 months, or since hatching, if the  3 weeks, or since hatching, if 3 weeks, or since hatching, if the
   poultry, productive poultry
                                   AC      animals are less than 3 months of     the animals are less than 3   animals are less than 3 weeks of
     and poulry intended for
                                                           age                          weeks of age                          age
   slaughter other than ratites
  Less than 20 day-old chicks      AC               Since hatching                     Since hatching                   Since hatching
EN                                                                           7                                                                    EN
 ---pagebreak---        other than ratites                                                    3 weeks prior to the date of
                                                                          collection of the eggs from which
                                  FO 3 months           3 weeks
                                                                            the day-old chicks have been
                                                                                        hatched
                                                                          3 weeks, or since hatching, if the
         Captive birds            AC   NA       3 weeks or since hatching  animals are less than 3 weeks of
                                                                                          age
  AC = Animals of the consignment
  FO = Flock of origin
  NA = not applicable
EN                                            8                                                              EN
 ---pagebreak---                                                                                ANNEX IV
  PART A
  1.     Minimum periods of disease freedom of the third country or territory of origin or zone thereof, as provided for in Article 22(1) for
         ungulates other than equine animals:
                                                                                                                                                             7. Ungulates other than
                                                  1.Bovine          2. Ovine        3. Caprine         4. Porcine         5. Camelid         6. Cervid
                                                                                                                                                                those referred to in
                                                   animals          animals           animals           animals             animals           animals
                                                                                                                                                               columns 1,2,3,4,5,6,*
              Foot and mouth disease            24 months**       24 months**      24 months**       24 months**         24 months**       24 months**             24 months**
           Infection with rinderpest virus       12 months         12 months         12 months         12 months           12 months         12 months              12 months
          Infection with Rift Valley fever
                                                 12 months         12 months         12 months             NA              12 months         12 months              12 months
                        virus
            Infection with Mycoplasma
           mycoides subsp. mycoides SC
                                                 12 months             NA               NA                 NA                 NA                 NA                 12 months
                (Contagious bovine
                 pleuropneumonia)
           Infection with peste des petits
                                                     NA            12 months         12 months             NA              12 months         12 months                  NA
                   ruminants virus
              Sheep pox and goat pox                 NA            12 months         12 months             NA                 NA                 NA                     NA
                 Contagious caprine
                                                     NA            12 months         12 months             NA                 NA                 NA                 12 months
                  pleuropneumonia
                African swine fever                  NA                NA               NA             12 months              NA                 NA                     NA
               Classical swine fever                 NA                NA               NA           12 months**              NA                 NA                 12 months
             Infection with lumpy skin
                                                 12 months             NA               NA                 NA                 NA                 NA                     NA
                    disease virus
         *       only applicable for listed species in accordance with the Annex to Commission Implementing Regulation (EU) 2018/1882
         **      or specific conditions are provided by the competent authority of the third country or territory in accordance with Part B as provided for in Article 22(3)
         NA = not applicable
EN                                                                                         9                                                                                         EN
 ---pagebreak---   2. Minimum periods of disease freedom of the third country or territory of origin or zone thereof in accordance with Article 22(2)(a) for
     equine animals:
      African horse sickness                         24 months
  3. Minimum periods during which disease has not been reported in the third country or territory of origin or zone thereof in accordance
     with Article 22(2)(b) for equine animals:
      Venezuelan equine encephalomyelitis           24 months
      Infection with Burkholderia mallei
                                                    36 months**
      (Glanders)
      Dourine                                       24 months**
      Surra (Trypanosoma evansi)                    24 months**
     ** or specific conditions are provided by the competent authority of the third country or territory in accordance with Part B as provided for in Article
            22(3)
EN                                                                           10                                                                               EN
 ---pagebreak---   PART B
  Specific conditions to be provided by the competent authority of the third country or territory where the third country or territory or zone thereof
  has been free from certain diseases for less than the period set out in the table in Part A of this Annex as referred to in Article 22(3):
                              Supplementary information to determine the date from which the third country or territory or zone thereof is
   Foot and mouth disease
                              considered to be free from foot and mouth disease.
                              (a) supplementary information to determine the date from which the third country or territory or zone thereof is
                              considered to be free from classical swine fever;
    Classical swine fever
                              (b) the animals intended for entry into the Union have reacted negatively to a test for the detection of classical swine
                              fever, carried out within a period of 30 days prior to the date of dispatch to the Union.
                              (a) the disease not reported in the establishment of origin during a period of at least 6 months prior to the date of
       Infection with         dispatch to the Union;
    Burkholderia mallei
         (Glanders)            (b) the Commission has recognised the surveillance programme carried out in breeding equine animals in the
                              establishment of origin to demonstrate absence of infection during that period of 6 months.
                              (a) the disease not reported in the establishment of origin for a period at least 6 months prior to the date of dispatch to
                              the Union;
          Dourine
                               (b) the Commission has recognised the surveillance programme carried out to demonstrate the absence of infection
                              in the establishment of origin during that period of 6 months.
                              (a) the disease has not been reported in the establishment of origin for a period of at least the 6 months prior to the
    Surra (Trypanosoma        date of dispatch to the Union;
           evansi)             (b) the Commission has recognised the surveillance programme carried out to demonstrate the absence of infection
                              in the establishment of origin during that period of 6 months.
EN                                                                              11                                                                        EN
 ---pagebreak---   PART C
  1.     Requirements as regards the absence of vaccination for the third country or territory of origin or zone thereof and for the ungulates other
         than equine animals as referred to in Article 22(4)(a):
                                                                                                                                                 7. Ungulates others
                                                1.Bovine       2. Ovine         3. Caprine     4. Porcine      5. Camelid        6. Cervid      than those referred to
                                                animals         animals          animals        animals          animals          animals            in columns
                                                                                                                                                     1,2,3,4,5,6*
               Foot and mouth disease          NV/ NVA        NV/ NVA           NV/ NVA        NV/ NVA         NV/ NVA           NV/ NVA              NV/ NVA
           Infection with rinderpest virus     NV/ NVA        NV/ NVA           NV/ NVA        NV/ NVA         NV/ NVA           NV/ NVA              NV/ NVA
                Rift Valley fever virus        NV/ NVA        NV/ NVA           NV/ NVA            NA          NV/ NVA           NV/ NVA              NV/ NVA
             Infection with Mycoplasma
            mycoides subsp. mycoides SC
                                               NV/ NVA            NA                NA             NA              NA               NA                NV/ NVA
                 (Contagious bovine
                  pleuropneumonia)
            Infection with peste des petits
                                                   NA         NV/ NVA           NV/ NVA            NA          NV/ NVA           NV/ NVA                 NA
                    ruminants virus
               Sheep pox and goat pox              NA         NV/ NVA           NV/ NVA            NA              NA               NA                   NA
                 Contagious caprine
                                                   NA         NV/ NVA           NV/ NVA            NA              NA               NA                NV/ NVA
                   pleuropneumonia
                Classical swine fever              NA             NA                NA         NV/ NVA             NA               NA                   NA
              Infection with lumpy skin
                                                  NVA             NA                NA             NA              NA               NA                   NA
                     disease virus
         NV = for a period of at least 12 months prior to the date of dispatch to the Union, no vaccination has been carried out in the third country, territory or zone
         and no vaccinated animals entered into the third country territory or zone
         NVA = the animals intended for the entry into the Union have not been vaccinated
         NA = not applicable
         * only applicable for listed species in accordance with the Annex to Commission Implementing Regulation (EU) 2018/1882
EN                                                                                 12                                                                                  EN
 ---pagebreak---   2. Requirements as regards the absence of vaccination for the third country or territory of origin or zone thereof and for the equine animals as
     referred to in Article 22(4)(b):
                                                                   - No systematic vaccination has been carried out in in the third country
                                                                      or territory of origin or zone thereof during a period of at least 12
                          African horse sickness                      months prior to the date of dispatch to the Union and the equine
                                                                      animals have not been vaccinated at least in the last 40 days prior to
                                                                      dispatch to the Union
                                                                   - The equine animals have not been vaccinated at least in the last 60 days
                  Venezuelan equine encephalomyelitis
                                                                      prior to dispatch to the Union
EN                                                                   13                                                                          EN
 ---pagebreak---                                             ANNEX V
         REQUIREMENTS FOR ENTRY INTO THE UNION AS REGARDS THE DISEASE
   FREEDOM OF THE THIRD COUNTRY OR TERRITORY OF ORIGIN OR ZONE THEREOF
      FROM INFECTION WITH MYCOBACTERIUM TUBERCULOSIS COMPLEX (M. BOVIS,
        M.CAPRAE, M. TUBERCULOSIS) AND INFECTION WITH BRUCELLA ABORTUS, B.
                                     MELITENSIS AND B. SUIS
   1.      INFECTION WITH MYCOBACTERIUM TUBERCULOSIS COMPLEX (M.                          BOVIS,
           M.CAPRAE AND M. TUBERCULOSIS)(AS REFERRED TO IN ARTICLE 22(5))
   1.1.    Bovine animals
           Where bovine animals do not originate from a third country or territory or zone
           thereof free of Mycobacterium tuberculosis complex (M. bovis, M.caprae, M.
           tuberculosis) as regards bovine animals, they must comply with one of the following
           requirements:
           (a)   they have been tested using one of the diagnostic methods provided for in Part
                 2 of Annex I to Commission Delegated Regulation (EU) 2019/… as regards
                 animal health requirements for movements within the Union of terrestrial
                 animals and hatching eggs [document C(2019)4058] for infection with
                 Mycobacterium tuberculosis complex (M. bovis, M. caprae and M.
                 tuberculosis), with negative results, during the period of 30 days prior to the
                 date of dispatch to the Union; or
           (b)   they are less than 6 weeks old.
   2.      INFECTION WITH BRUCELLA ABORTUS, B. MELITENSIS AND B. SUIS (AS REFERRED TO
           IN ARTICLE 22(6))
   2.1.    Bovine animals
           Where bovine animals do not originate from a third country or territory or zone
           thereof free of Brucella abortus, B. melitensis and B. suis without vaccination as
           regards bovine animals, they must comply with one of the following requirements:
           (a)   they have been tested using one of the diagnostic methods provided for in Part
                 1 of Annex I to Commission Delegated Regulation (EU) 2019/… as regards
                 animal health requirements for movements within the Union of terrestrial
                 animals and hatching eggs [document C(2019)4058] for infection with
                 Brucella abortus, B. melitensis and B. suis, with negative results, on a sample
                 taken during the period of 30 days prior to the date of dispatch to the Union
                 and, in the case of post-parturient females, the test has been carried out on a
                 sample taken at least 30 days after parturition; or
           (b)   they are less than 12 months old; or
           (c)   they are castrated.
   2.2.    Ovine and caprine animals
           Where ovine and caprine animals do not originate from a third country or territory or
           zone thereof free of Brucella abortus, B. melitensis and B. suis without vaccination
           as regards ovine and caprine animals, they must comply with one of the following
           requirements:
EN                                               14                                              EN
 ---pagebreak---    (a) they have been tested using one of the diagnostic methods provided for in Part
       1 of Annex I to Commission Delegated Regulation (EU) 2019/… as regards
       animal health requirements for movements within the Union of terrestrial
       animals and hatching eggs [document C(2019)4058] for infection with
       Brucella abortus, B. melitensis and B. suis, with negative results, on a sample
       taken during the period of 30 days prior to the date of dispatch to the Union
       and, in the case of post-parturient females, the test has been carried out on a
       sample taken at least 30 days after parturition; or
   (b) they are less than 6 months old; or
   (c) they are castrated.
EN                                     15                                              EN
 ---pagebreak---                                                ANNEX VI
                                                 PART A
                  SPECIFIC CONDITIONS FOR THE ENTRY INTO THE UNION OF UNGULATES AS
                 REGARDS THE DISEASE FREEDOM OF THE THIRD COUNTRY OR TERRITORY OF
                    ORIGIN OR ZONE THEREOF FROM INFECTION WITH BLUETONGUE VIRUS
                                  (SEROTYPES 1-24) FOR A PERIOD OF 2 YEARS
                                        (AS REFERRED TO IN ARTICLE 22(7))
   Where ungulates of listed species do not originate from a third country or territory or zone
   thereof free from infection with bluetongue virus (serotypes 1-24), they must originate from a
   third country or territory or zone thereof which complies with at least one of the following
   requirements:
   (a)      the animals have been kept in a third country or territory or zone thereof seasonally
            free from infection with bluetongue virus (serotypes 1-24) as defined in Commission
            Delegated Regulation (EU) 2019/… as regards rules for surveillance, eradication
            programmes, and disease-free status for certain listed and emerging diseases
            [document C(2019)4056]:
            (i)    for a period of at least 60 days prior to the date of dispatch to the Union; or
            (ii)   for a period of at least 28 days prior to the date of dispatch to the Union, and
                   have undergone a serological test, with negative results, carried out on samples
                   collected at least 28 days following the date of the animal’s entry into the third
                   country or territory or zone thereof seasonally free from infection with
                   bluetongue virus (serotypes 1-24); or
            (iii) for a period of at least 14 days prior to the date of dispatch to the Union, and
                   have undergone a polymerase chain reaction (PCR) test, with negative results,
                   carried out on samples collected at least 14 days following the date of the
                   animal’s entry into the third country or territory or zone thereof that is
                   seasonally free of BTV.
   (b)      the animals originate from a third country, territory or zone thereof with a
            surveillance system in place designed and implemented in accordance with Sections
            1 and 2 of Chapter 1, Part II of Annex to Commission Delegated Regulation (EU)
            2019/… as regards rules for surveillance, eradication programmes, and disease-free
            status for certain listed and emerging diseases [document C(2019)4056] and have
            been vaccinated against all the serotypes (1 to 24) of bluetongue virus reported
            during the preceding 2 years in that third country, territory or zone thereof, and the
            animals are still within the immunity period of time guaranteed in the specifications
            of the vaccine, and the animals comply with at least one of the following
            requirements:
            (i)    they have been vaccinated more than 60 days prior to the date of dispatch to
                   the Union; or
            (ii)   they have been vaccinated with an inactivated vaccine and have undergone a
                   PCR test, with negative results on samples collected at least 14 days after the
                   onset of the immunity protection set in the specifications of the vaccine.
   (c)      the animals originate from a third country, territory or zone thereof with a
            surveillance system in place designed and implemented in accordance with Sections
            1 and 2 of Chapter 1, Part II of Annex to Commission Delegated Regulation (EU)
EN                                                  16                                                EN
 ---pagebreak---            2019/… as regards rules for surveillance, eradication programmes, and disease-free
           status for certain listed and emerging diseases [document C(2019)4056] and the
           animals have undergone, with positive results, a serological test able to detect
           specific antibodies against all serotypes (1-24) bluetongue virus reported during the
           preceding 2 years in that third country or territory or zone thereof, and:
           (i)    the serological test must have been carried out on samples collected at least 60
                  days prior to the date of movement;
                  or
           (ii)   the serological test must have been carried out on samples collected at least 30
                  days prior to the date of movement and the animals were subjected to a PCR
                  test, with negative results, carried out on samples collected not earlier than 14
                  days prior to the date of dispatch to the Union.
                                                PART B
               SPECIFIC CONDITIONS FOR THE ENTRY INTO THE UNION OF CONSIGNMENTS OF
            BOVINE ANIMALS AS REGARDS THE DISEASE FREEDOM OF THE THIRD COUNTRY OR
                TERRITORY OF ORIGIN OR ZONE THEREOF FOR ENZOOTIC BOVINE LEUKOSIS
                                      (AS REFERRED TO IN ARTICLE 22(8))
   Where bovine animals do not originate from a third country or territory or zone thereof free of
   enzootic bovine leukosis, they must come from an establishment where that disease has not
   been reported during the period of 24 months prior to the date of dispatch to the Union, and:
   (a)     if the animals are over the age of 24 months, they have been subjected to a laboratory
           examination for enzootic bovine leukosis using one of the diagnostic methods
           provided for in Part 4 of Annex I to Commission Delegated Regulation (EU)
           2019/…as regards animal health requirements for movements within the Union of
           terrestrial animals and hatching eggs [document C(2019)4058], carried out, with
           negative results either:
           (a)    on samples taken on two occasions at an interval of at least 4 months while the
                  animals were kept in isolation from the other bovine animals of the same
                  establishment; or
           (b)    on a sample taken during the last 30 days prior to their dispatch to the Union,
                  and all bovine animals over 24 months kept in the establishment have been
                  subjected to a laboratory examination for enzootic bovine leucosis with one of
                  the diagnostic methods provided for in Part 4 of Annex I to Commission
                  Delegated Regulation (EU) 2019/…as regards animal health requirements for
                  movements within the Union of terrestrial animals and hatching eggs
                  [document C(2019)4058], carried out, with negative results, on samples taken
                  on two occasions at an interval of not less than 4 months during the last 12
                  months prior to the date of dispatch to the Union;
   (b)     if the animals are less than 24 months of age, they were born to dams, which have
           been subjected to a laboratory examination for enzootic bovine leukosis using one of
           the diagnostic methods provided for in Part 4 of Annex I to Commission Delegated
           Regulation (EU) 2019/… as regards animal health requirements for movements
           within the Union of terrestrial animals and hatching eggs [document C(2019)4058],
           carried out, with negative results, on samples taken on two occasions at an interval of
           not less than 4 months during the period of 12 months prior to the date of dispatch to
           the Union.
EN                                                 17                                               EN
 ---pagebreak---                                             ANNEX VII
        ADDITIONAL REQUIREMENTS FOR THE ENTRY INTO THE UNION OF UNGULATES AS
                                REGARDS CERTAIN CATEGORY C DISEASES
                                     (AS REFERRED TO IN ARTICLE 22(9))
   1.      INFECTIOUS BOVINE RHINOTRACHEITIS / INFECTIOUS PUSTULAR VULVOVAGINITIS
   1.1.    Bovine animals
           The animals must have not been vaccinated and they must have been kept in
           quarantine for a period of at least 30 days prior to the date of dispatch to the Union
           and have undergone a serological test for the detection of antibodies against whole
           BoHV-1. One of the diagnostic methods provided for in Part 5 of Annex I to
           Commission Delegated Regulation (EU) 2019/… as regards animal health
           requirements for movements within the Union of terrestrial animals and hatching
           eggs [document C(2019)4058] must have been used, and a negative result obtained.
           In addition, the test must have been carried out on a sample collected in the
           establishment of origin within the period of 15 days prior to the date of dispatch for
           the Union.
   1.2.    Camelid and cervid animals
           Camelid and cervid animals intended for entry into a Member State or zone thereof
           with disease-free status or with an approved eradication programme regarding
           infectious bovine rhinotracheitis / infectious pustular vulvovaginitis in bovine
           animals, must come from an establishment in which infectious bovine rhinotracheitis
           / infectious pustular vulvovaginitis has not been reported on animals of the same
           species as the animals of the consignment during the last 30 days prior to dispatch to
           the Union.
   2.      BOVINE VIRAL DIARRHOEA
           The animals have not been vaccinated against bovine viral diarrhoea and must have
           been tested for bovine viral diarrhoea virus antigen or genome using one of the
           diagnostic methods provided for in Part 6 of Annex I to Commission Delegated
           Regulation (EU) 2019/… as regards animal health requirements for movements
           within the Union of terrestrial animals and hatching eggs [document C(2019)4058],
           with negative results, and either:
           (a)   the animals have been kept in an approved quarantine establishment for a
                 period of at least 21 days prior to their departure and, in the case of pregnant
                 dams, they have been subjected to a serological test for the detection of
                 antibodies against bovine viral diarrhoea virus using one of the diagnostic
                 methods provided for in Part 6 of Annex I to Commission Delegated
                 Regulation (EU) 2019/… as regards animal health requirements for
                 movements within the Union of terrestrial animals and hatching eggs
                 [document C(2019)4058], with negative results, carried out on samples taken
                 not less than 21 days after commencement of the quarantine; or
           (b)   the animals have been subjected to a serological test for the detection of
                 antibodies against bovine viral diarrhoea virus using one of the diagnostic
                 methods provided for in Part 6 of Annex I to Commission Delegated
                 Regulation (EU) 2019/… as regards animal health requirements for
EN                                               18                                               EN
 ---pagebreak---             movements within the Union of terrestrial animals and hatching eggs
            [document C(2019)4058], with positive results, carried out on samples taken
            either prior to departure or, in the case of pregnant dams, before insemination
            preceding the current gestation.
   3. INFECTION WITH AUJESZKY’S DISEASE VIRUS
      The animals have not been vaccinated against infection with Aujeszky’s disease
      virus and must have been:
      (a)   kept in an approved quarantine establishment for a period of at least 30 days;
            and
      (b)   subjected to a serological test for the detection of antibodies against whole
            Aujeszky’s disease virus with the diagnostic method provided for in Part 7 of
            Annex I to Commission Delegated Regulation (EU) 2019/… as regards animal
            health requirements for movements within the Union of terrestrial animals and
            hatching eggs [document C(2019)4058], with a negative result, carried out on
            samples taken on two occasions at an interval of not less than 30 days, the last
            sample taken during the period of 15 days prior to the date of dispatch to the
            Union.
EN                                           19                                              EN
 ---pagebreak---                                                                                              ANNEX VIII
                   ANIMAL HEALTH REQUIREMENTS AS REGARDS THE ESTABLISHMENT OF ORIGIN OF UNGULATES
  1.           Minimum areas (radius) and periods (prior to dispatch to the Union) without reported disease in the area in and around the establishment of origin of
               the ungulates other than equine animals, as referred to in Article 23(1)(a)(i):
                                                                                                                                                                                  7. Ungulates others than
                                                                                                                     4. Porcine            5. Camelid
                                               1. Bovine animals      2. Ovine animals     3. Caprine animals                                              6. Cervid animals         those referred to in
                                                                                                                       animals               animals
                                                                                                                                                                                    columns 1,2,3,4,5,6*
          Foot and mouth disease              10 km /30 days           10 km /30 days        10 km /30 days        10 km /30 days        10 km /30 days      10 km /30 days            10 km /30 days
      Infection with rinderpest virus           10 km /30 days         10 km /30 days        10 km /30 days        10 km /30 days        10 km /30 days      10 km /30 days            10 km /30 days
  Infection with Rift Valley fever virus        10 km /30 days         10 km /30 days        10 km /30 days              NA              10 km /30 days      10 km /30 days            10 km /30 days
  Infection with Mycoplasma mycoides
     subsp. mycoides SC (Contagious             10 km /30 days               NA                    NA                    NA                    NA                  NA                  10 km / 30 days
         bovine pleuropneumonia)
      Infection with peste des petits
                                                      NA               10 km /30 days        10 km /30 days              NA              10 km /30 days     10 km / 30 days                  NA
              ruminants virus
          Sheep pox and goat pox                      NA               10 km /30 days        10 km /30 days              NA                    NA                  NA                        NA
  Contagious caprine pleuropneumonia                  NA               10 km /30 days        10 km /30 days              NA                    NA                  NA                  10 km /30 days
            African swine fever                       NA                     NA                    NA              10 km /30 days              NA                  NA                        NA
           Classical swine fever                      NA                     NA                    NA              10 km /30 days              NA                  NA                        NA
    Infection with lumpy skin disease
                                                10 km /30 days               NA                    NA                    NA                    NA                  NA                        NA
                    virus
          Infection with epizootic                                         150 km/               150 km/                                     150 km/             150 km/                   150 km/
                                              150 km/ 2 years**                                                          NA
        haemorrhagic disease virus                                        2 years**             2 years**                                   2 years**           2 years**                 2 years**
  *            only applicable for listed species in accordance with the Annex to Commission Implementing Regulation (EU) 2018/1882
  **           not applicable if the animals originate from a third country, territory or zone thereof seasonally free of the disease in accordance with the relevant Chapter of the Terrestrial Animal
               Health Code of the World Animal Health Organisation (OIE)
EN                                                                                                       20                                                                                                EN
 ---pagebreak---   NA = not applicable
  2.        Minimum periods without reported disease in the establishment of origin for ungulates other than equine animals as referred to in Article
            23(1)(a)(i):
                                                                                                                                                   7. Ungulates
                                                                                                                                                others than those
                                      1. Bovine         2. Ovine        3. Caprine      4. Porcine                                6. Cervid
                                                                                                        5. Camelid animals                        referred to in
                                       animals          animals           animals         animals                                  animals
                                                                                                                                                      columns
                                                                                                                                                   1,2,3,4,5,6*
       Burkholderia mallei                                                                                Same as equine
                                                   NA                    6 months           NA                                                NA
            (Glanders)                                                                                   animals (point 4)
               Rabies                                                                         30 days
  Surra (Trypanosoma evansi)          30 days**        30 days**        30 days**           NA               30 days**           30 days**          30 days**
              Anthrax                                                                         15 days
    Infection with Aujeszky’s
                                                           NA                             30 days                                   NA
           disease virus
  *          only applicable for listed species in accordance with the Annex to Commission Implementing Regulation (EU) 2018/1882
  **         if the disease was reported in the establishment of origin during the period of 2 years prior to the date of dispatch to the Union, following the last
             outbreak the affected establishment must have remained under restriction until:
            (a)     the infected animals were removed from the establishment;
            (b)     the remaining animals on the establishment underwent, with negative result, a test for surra (Trypanosoma evansi) as described in
                    Part 3 of Annex I to Commission Delegated Regulation (EU) 2019/… as regards animal health requirements for movements
                    within the Union of terrestrial animals and hatching eggs [document C(2019)4058] carried out on samples taken at least 6 months
                    after the infected animals were removed from the establishment.
  NA = not applicable
EN                                                                                  21                                                                              EN
 ---pagebreak---    3.         Minimum areas (radius) and periods without a reported case or outbreak of equine
              infectious anaemia in the area in and around the establishment of origin of equine
              animals as referred to in Article 23(1)(a)(ii):
                                               Requirements to be complied with where there has been an
                      Area     Period
                                                               outbreak in the establishment
                                            All the equine animals were isolated until they were subjected a
        Equine
                                      1      serological test for equine infectious anaemia carried out with
      infectious     200 m   3 months
                                             negative results on two samples taken after the slaughter of the
       anaemia
                                                            infected animal and 3 months apart
   4.         Minimum periods without a reported case or outbreak of certain diseases in the
              establishment of origin for equine animals as referred to in Article 23(1)(a)(ii):
                                                 Requirements to be complied with where there has been a
                             Period
                                                          previous outbreak in the establishment
                                          Where an infection was reported in the establishment during the
                                          period of 3 years prior to the date of dispatch to the Union,
                                          following the last outbreak the establishment remained under
                                          movement restrictions by the competent authority until:
       Infection with                     –          the infected animals have been killed and destroyed; and
        Burkholderia        6 months      –          the remaining animals were subjected to a test carried
    mallei (Glanders)                                out as described in point 3.1 of Chapter 2.5.11 of the
                                                     OIE Terrestrial Manual (Version adopted 2015) with
                                                     negative results on samples taken at least 6 months after
                                                     the date on which the infected animals were killed and
                                                     destroyed and the establishment cleaned and disinfected
                                          If they come from an establishment situated in a third country,
                                          territory or zone thereof in which Venezuelan equine
                                          encephalomyelitis has been reported during the last 2 years prior
                                          to the date of dispatch to the Union, they comply with the
                                          conditions in point (i) and the conditions in either of points (ii) or
                                          (iii):
                                                     (i)     during the period of at least 21 days prior to
                                                     departure they have remained clinically healthy and any
                                                     animal referred to in point (ii) or (iii) which showed a
                                                     rise in body temperature, taken daily, have been
                                                     subjected to a diagnostic test for Venezuelan equine
   Venezuelan equine                                 encephalomyelitis with the diagnostic method provided
                            6 months
    encephalomyelitis                                for in point (a) of Part 10(1) of Annex I of [document
                                                     C(2019)4058], with negative results; and
                                                     (ii) the animals were kept in quarantine for a period
                                                     of at least 21 days protected from attacks by insect
                                                     vector, and either
                                                            –      have been vaccinated against Venezuelan
                                                                   equine encephalomyelitis with a complete
                                                                   primary course and revaccinated according
                                                                   to manufacturer's recommendations not less
                                                                   than 60 days and not more than 12 months
                                                                   prior to the date of dispatch; or
EN                                                    22                                                      EN
 ---pagebreak---                                          –      have been subjected to a test for
                                                Venezuelan equine encephalomyelitis with
                                                the diagnostic method provided for in point
                                                (b) of Part 10(1) of Annex I of [document
                                                C(2019)4058], with negative results,
                                                carried out on a sample taken not less than
                                                14 days after the date of entry into
                                                quarantine;
                                  (iii)  the animals have been subjected to
                                         –      a      test   for      Venezuelan      equine
                                                encephalomyelitis with the diagnostic
                                                method provided for in point (b) of Part
                                                10(1) of Annex I of [document
                                                C(2019)4058], without an increase in
                                                antibody titre, carried out on paired samples
                                                taken on two occasions with an interval of
                                                21 days, the second of which was taken
                                                during a period of 10 days prior to the date
                                                of departure; and
                                         –      a test for the detection of Venezuelan
                                                equine encephalomyelitis virus genome
                                                with the diagnostic method provided for in
                                                Part 10(2) of Annex I [document
                                                C(2019)4058], with negative result, carried
                                                out on a sample taken within 48 hours prior
                                                to departure, and the animals have been
                                                protected from attacks by insect vectors
                                                after sampling until departure.
                         Where an infection was reported in the establishment during the
                         period of 2 years prior to the date of dispatch to the Union,
                         following the last outbreak the establishment remained under
                         movement restriction by the competent authority until:
                         –        the infected animals have been killed and destroyed or
                                  slaughtered, or the infected entire male equine animals
                                  have been castrated; and
      Dourine   6 months –        the remaining equine animals in the establishment, with
                                  the exception of the castrated male equine animals
                                  referred to in first indent kept apart from female equine
                                  animals, were subjected to a test for dourine with the
                                  diagnostic method provided for in Part 8 of Annex I of
                                  [document C(2019)4058] with negative results, carried
                                  out on samples taken at least 6 months after the
                                  measures described in the first indent have been
                                  completed.
                         Where infection was reported in the establishment during the
       Surra             period of 2 years prior to the date of dispatch to the Union, the
   (Trypanosoma 6 months establishment remained under movement restriction by the
      evansi)            competent authority until:
                         –        the infected animals have been removed from the
EN                                 23                                                       EN
 ---pagebreak---                                       establishment; and
                             –        the remaining animals have undergone a test for surra
                                      (Trypanosoma evansi) using one of the diagnostic
                                      methods provided for in [Part 3 of Annex I of document
                                      C(2019)4058] with negative results, carried out on
                                      samples taken at least 6 months after the last infected
                                      animal has been removed from the establishment.
                             Where an infection was reported in the establishment during the
                             period of 12 months prior to the date of dispatch to the Union,
                             following the last outbreak the establishment remained under
                             movement restriction by the competent authority until:
                             –        the infected animals have been killed and destroyed or
                                      slaughtered; and
   Equine infectious
                     90 days –        the remaining animals in the establishment have been
       anemia                         subjected to a test for equine infectious anemia with the
                                      diagnostic method provided for in Part 9 of Annex I of
                                      [document C(2019)4058] with negative results, carried
                                      out on samples taken on two occasions with a minimum
                                      interval of 3 months after the measures described in the
                                      first indent have been completed and the establishment
                                      was cleaned and disinfected.
        Rabies       30 days                                  -
       Anthrax       15 days                                  -
EN                                     24                                                     EN
 ---pagebreak---                                              ANNEX IX
   1.       INFECTION WITH MYCOBACTERIUM TUBERCULOSIS COMPLEX (M.                              BOVIS,
            M.CAPRAE AND M. TUBERCULOSIS)(AS REFERRED TO IN ARTICLE 23(2))
        Species                    Requirements as regards the establishment of origin
    Bovine animals                             Free as regards bovine animals
                    In the establsihment, infection with Mycobacterium tuberculosis complex (M.
     Ovine animals  bovis, M. caprae and M. tuberculosis) has not been reported during the last 42
                    days prior to dispatch to the Union
                    In the establsihment, surveillance for infection with Mycobacterium tuberculosis
    Caprine animals complex (M. bovis, M. caprae and M. tuberculosis) has been carried out on
                    animals of the same species as the animals of the consignment kept on the
                    establishments in accordance with the procedures provided for in point 1 and 2 of
   Camelid animals  Part 1 of Annex II to Commission Delegated Regulation (EU) 2019/… document
                    C(2019)4058] during at least the last 12 months prior to dispatch to the Union and
                    during this period:
                    (a)       only animals of the same species as the animals of the
                              consignment from establishments applying the measures provided
                              in the paragraph have been introduced in the establishment;
                    (b)       in case infection with Mycobacterium tuberculosis complex (M.
    Cervid animals
                              bovis, M. caprae and M. tuberculosis) has been reported in
                              animals of the same species as the animals of the consignment
                              kept on the establishment, measures were taken in accordance
                              with Part 1(3) of Annex II to Commission Delegated Regulation
                              (EU) 2019/… document C(2019)4058].
   2.       INFECTION WITH BRUCELLA ABORTUS, B. MELITENSIS AND B. SUIS (AS REFERRED TO
            IN ARTICLE 23(3))
        Species                    Requirements as regards the establishment of origin
    Bovine animals   The establsihment is free without vaccination as regards bovine animals
                     The establsihment is free without vaccination as regards ovine and caprine
     Ovine animals
                     animals
                     The establsihment is free without vaccination as regards ovine and caprine
   Caprine animals
                     animals
                     In the establishment, infection with Brucella abortus, B. melitensis and B. suis
                     has not been reported during the last 42 days prior to dispatch to the Union and
                     during the last 12 months prior to dispatch to the Union:
    Porcine animals  (a)       biosecurity and risk mitigating measures, including housing
                               conditions and feeding systems, have been applied in the
                               establishment as necessary to prevent transmission of infection
                               with Brucella abortus, B. melitensis and B. suis from wild animals
                               of listed species to porcine animals kept on the establishment and
EN                                                 25                                                  EN
 ---pagebreak---                              only porcine animals from establishments applying equivalent
                             biosecurity measures have been introduced; or
                   (b)       surveillance for infection with Brucella abortus, B. melitensis and
                             B. suis has been carried out on the porcine animals kept on the
                             establishment in accordance with Annex III to Commission
                             Delegated Regulation (EU) 2019/… document C(2019)4058, and
                             during the same period:
                             –      only porcine animals from establishments applying the
                                    biosecurity measures or the surveillance measures provided for in
                                    points (a) or (b) have been introduced in the establishment; and
                             –      in case infection with Brucella abortus, B. melitensis and B. suis
                                    has been reported in porcine animals kept on the establishment,
                                    measures were taken in accordance with [Part 1(3) of Annex II to
                                    Commission Delegated Regulation (EU) 2019/… document
                                    C(2019)4058]
                   Infection with Brucella abortus, B. melitensis and B. suis in camelid animals has
                   not been reported during the last 42 days prior to dispatch to the Union, and they
                   have been subjected to a test for the detection of infection with Brucella abortus,
                   B. melitensis and B. suis with one of the diagnostic methods provided for in Part 1
   Camelid animals
                   of Annex I to Commission Delegated Regulation (EU) 2019/… document
                   C(2019)4058, with negative results, carried out on a sample taken during the last
                   30 days prior to dispatch to the Union, and in the case of post-parturient females,
                   taken at least 30 days after parturition
                   Infection with Brucella abortus, B. melitensis and B. suis in cervid animals has
   Cervid animals
                   not been reported during the last 42 days prior to ddispatch to the Union
EN                                                26                                                   EN
 ---pagebreak---                                             ANNEX X
      SPECIFIC REQUIREMENTS FOR ENTRY INTO THE UNION OF CERTAIN
    SPECIES AND CATEGORIES OF UNGULATES AS REGARDS INFECTION WITH
                    BRUCELLA AS REFERRED TO IN ARTICLE 24(5)
   1.     OVINE ANIMALS:
          Uncastrated males of ovine animals, others than those intended for slaughter in the
          Union, must comply with the following requirements:
          (a)   they have remained for a continuous period of at least 60 days in an
                establishment where infection with Brucella ovis (contagious epididymitis) has
                not been reported during the period of 12 months prior to the date of dispatch
                to the Union;
          (b)   they have undergone a serological test for the detection of Brucella ovis
                (contagious epididymitis), with negative results, during the 30 days prior to the
                date of dispatch to the Union.
   2.     UNGULATES OF THE FAMILY TAYASSUIDAE
          Ungulates of the family Tayassuidae must have undergone a test for the detection of
          Brucella suis using one of the diagnostic methods provided for in point 2 of Part 1 of
          Annex I of document C(2019)4058], with negative results, during the period of 30
          days prior to the date of dispatch to the Union.
EN                                               27                                               EN
 ---pagebreak---                                                ANNEX XI
       SPECIFIC REQUIREMENTS FOR EQUINE ANIMALS AS REFERRED TO IN
                                            ARTICLE 24(6)
   1.       SANITARY GROUPS TO WHICH THIRD COUNTRIES, TERRITORIES OR ZONES THEREOF
            ARE ASSIGNED
   Sanitary
                               Diseases for which specific requirements are required
     group
        A      equine infectious anaemia
        B      equine infectious anaemia, glanders, dourine
        C      equine infectious anaemia, Venezuelan equine encephalomyelitis
        D      equine infectious anaemia, glanders, dourine, Venezuelan equine encephalomyelitis, surra
        E      equine infectious anaemia, glanders, dourine, African horse sickness, surra
        F      equine infectious anaemia, dourine, African horse sickness
       G       equine infectious anaemia, glanders, dourine, surra
   2.       SPECIFIC REQUIREMENTS
   2.1.     Specific requirements for African horse sickness:
            Equine animals must comply with the set of requirements laid down in one of the
            points set out below.
            (a)   the animals have been kept in isolation in vector-protected facilities for a
                  period of at least 30 days prior to dispatch to the Union and a serological and
                  an agent identification test for African horse sickness were carried out with
                  negative result in each case on a blood sample taken not less than 28 days after
                  the date of introduction into the vector-protected facilities and within a period
                  of 10 days prior to the date of dispatch;
            (b)   the animals have been kept in isolation in vector-protected facilities for a
                  period of at least 40 days prior to the date of dispatch to the Union and
                  serological tests to detect antibodies against African horse sickness -virus were
                  carried out with no significant increase in antibody titre on blood samples
                  collected on two occasions, with an interval of not less than 21 days, the first
                  sample being collected at least 7 days after introduction into the vector-
                  protected facilities;
            (c)   the animals have been kept in isolation in vector-protected facilities for a
                  period of at least 14 days prior to dispatch and an agent identification test for
                  African horse sickness virus was carried out with negative result on a blood
                  sample taken not less than 14 days after the date of introduction into the vector-
                  protected facilities and not more than 72 hours before the time of dispatch;
            (d)   there is documented evidence that the animals have been vaccinated against
                  African horse sickness with a complete primary course, and revaccinated
                  according to manufacturer’s instructions, with a licensed vaccine against all
                  serotypes of the African horse sickness virus present in the source population at
                  least 40 days prior to entry into the vector-protected facilities, and the animals
EN                                                  28                                                  EN
 ---pagebreak---              have been kept in isolation in vector-protected facilities for a period of at least
             40 days;
        (e)  the animals have been kept in isolation in vector-protected facilities for a
             period of at least 30 days prior to the date of dispatch to the Union and
             underwent a serological test for the detection of antibodies against the African
             horse sickness virus, carried out by the same laboratory, on the same day, on
             blood samples taken during the isolation period in vector-protected facilities on
             two occasions with an interval of between 21 and 30 days. The second of these
             must have been taken within a period of 10 days prior to the date of dispatch,
             with negative results in each case or with a negative result in an agent
             identification test for African horse sickness virus on the second sample.
   2.2. Specific requirements for Venezuelan equine encephalomyelitis
        Equine animals must comply with at least one of the following requirements:
        (a)  the animals have been vaccinated against Venezuelan equine encephalomyelitis
             with a complete primary course and revaccinated in accordance with the
             manufacturer’s recommendations during a period of not less than 60 days and
             not more than 12 months prior to the date of dispatch to the Union and have
             been kept in vector-protected quarantine for a period of at least 21 days prior to
             the date of dispatch to the Union, and during that period they have remained
             clinically healthy, and their body temperature, taken daily, has remained within
             the normal physiological range.
             Any other equine animal on the same establishment which showed a rise in
             body temperature, taken daily, was subjected to a blood test for virus isolation
             for Venezuelan equine encephalomyelitis with negative results.
         (b) the animals have not been vaccinated against Venezuelan equine
             encephalomyelitis and have been and were kept in vector-protected quarantine
             for a period of at least 21 days, and during that period they have remained
             clinically healthy, and their body temperature, taken daily, has remained within
             the normal physiological range. During quarantine the animals were subjected
             to a diagnostic test for Venezuelan equine encephalomyelitis, with negative
             results, conducted on a sample taken not less than 14 days after the date of
             entry of the animals into the vector-protected quarantine; the animals remained
             protected from vector insects until dispatch.
             Any other equine animal on the same establishment that showed a rise in body
             temperature, taken daily, was subjected to a blood test for virus isolation for
             Venezuelan equine encephalomyelitis with negative results.
         (c) the animals have been subjected to a haemagglutination inhibition test for
             Venezuelan equine encephalomyelitis carried out by the same laboratory on the
             same day on samples taken on two occasions with an interval of 21 days, the
             second of which was taken during a period of 10 days prior to the date of
             dispatch, without an increase in antibody titre, and a RT-PCR (reverse
             transcription polymerase chain reaction) test for the detection of Venezuelan
             equine encephalomyelitis virus genome, carried out with negative result on a
             sample taken within 48 hours prior to dispatch, and have been protected from
             vector attacks from the moment of the RT-PCR sampling until loading for
             dispatch, by combined use of approved insect repellents and insecticides on the
EN                                            29                                                 EN
 ---pagebreak---               animals and disinsection of the stable and the means in which they are
              transported.
   2.3. Specific requirements for infection with Burkholderia mallei (Glanders)
        Equine animals must have undergone a complement fixation test for glanders, as
        described in point 3.1 of Chapter 2.5.11 of the OIE Terrestrial Manual (Version
        adopted 2015). The test must have been carried out, with negative results, at a serum
        dilution of 1 in 5 on a blood sample taken within a period of 30 days prior to the date
        of dispatch to the Union.
   2.4. Specific requirements for dourine
        Equine animals must have undergone a complement fixation test for dourine, as
        described in point 3.1 of Chapter 2.5.3 of the OIE Terrestrial Manual (Version
        adopted 2013). The test must have been carried out, with negative results, at a serum
        dilution of 1 in 5 on a blood sample taken within a period of 30 days prior to the date
        of dispatch to the Union. In addition, the tested animals must not have been used for
        breeding during the period of at least 30 days prior to and after the date the sample
        was taken.
   2.5. Specific conditions for surra (Trypanosoma evansi)
        Equine animals must have undergone a card agglutination test for trypanosomiasis
        (CATT), as described in point 2.3 of Chapter 2.1.21 of the OIE Terrestrial Manual
        (Version adopted 2012). The test must have been carried out, with negative results, at
        a serum dilution of 1 in 4 on a blood sample taken within a period of 30 days prior to
        the date of dispatch to the Union.
   2.6. Specific conditions for equine infectious anaemia
        Equine animals must have undergone an agar gel immunodiffusion test (AGID test)
        or to an enzyme-linked immunoassay (ELISA) for equine infectious anaemia, as
        described in points 2.1 and 2.2 of Chapter 2.5.6 of the OIE Terrestrial Manual
        (Version adopted 2013). The test must have been carried out, with negative results,
        on a blood sample taken within a period not exceeding 90 days prior to the date of
        dispatch to the Union.
EN                                            30                                                EN
 ---pagebreak---                                                                         ANNEX XII
                                                  UNGULATES INTENDED FOR CONFINED ESTABLISHMENTS
  PART A: Minimum periods without reported disease in the confined establishment of origin of the ungulates intended for confined establishments in the
  Union:
                                                                                                                                     7. Ungulates others
                                                     1.Bovine  2. Ovine   3. Caprine     4. Porcine     5. Camelid      6. Cervid    than those referred
                                                      animals   animals     animals        animals        animals        animals        to in columns
                                                                                                                                         1,2,3,4,5,6*
  Foot and mouth disease                             6 months  6 months    6 months       6 months       6 months       6 months          6 months
  Infection with Rift Valley fever virus             6 months  6 months    6 months          NA          6 months       6 months          6 months
  Infection with Mycoplamsma mycoides subsp.
  Mycoides SC (Contagious bovine                     6 months     NA          NA             NA             NA             NA             6 months
  pleuropneumonia)
  Infection with peste des petits ruminants virus       NA     6 months    6 months          NA          6 months       6 months              NA
  Sheep pox and goat pox                                NA     6 months    6 months          NA             NA             NA                 NA
  Contagious caprine pleuropneumonia                    NA     6 months    6 months          NA             NA             NA             6 months
  African swine fever                                   NA        NA          NA             6m             NA             NA                 NA
  Classical swine fever                                 NA        NA          NA             6m             NA             NA                 NA
  Infection with lumpy skin disease virus               6m        NA          NA             NA             NA             NA                 NA
  Infection with Burkholderia mallei (Glanders)         NA        NA       6 months          NA          6 months          NA                 NA
  Infection with Brucella abortus, B. melitensis
  and B. suis
                                                     6 months  6 months    6 months       6 months       6 months       6 months          6 months
  Infection with Mycobacterium tuberculosis
  complex (M. bovis, M. caprae, M. tuberculosis)
                                                     6 months  6 months    6 months       6 months       6 months       6 months          6 months
  Rabies                                             6 months  6 months    6 months       6 months       6 months       6 months          6 months
  Surra (Trypanosoma evansi)                          30 days   30 days     30 days          NA          180 days        30 days           30 days
  Anthrax                                             30 days   30 days     30 days        30 days        30 days        30 days           30 days
EN                                                                             31                                                                        EN
 ---pagebreak---   Infection with bluetongue virus (Serotypes 1-24)  6 months       6 months       6 months        NA         6 months       6 months 6 months
  Infection with Aujeszky’s disease virus             NA              NA            NA         12 months         NA            NA      NA
  *           only applicable for listed species in accordance with the Annex to Commission Implementing Regulation (EU) 2018/1882
  NA = not applicable
EN                                                                                   32                                                       EN
 ---pagebreak---   PART B: Minimum areas (radius) and periods without reported disease in the area around the confined establishment of origin of the ungulates
  intended for confined establishments in the Union:
                                                                                                                                                       7. Ungulates others
                                                           2. Ovine                                                 5. Camelid
                                      1.Bovine animals                  3. Caprine animals   4. Porcine animals                    6. Cervid animals than those referred to
                                                           animals                                                   animals
                                                                                                                                                     in column 1,2,3,4,5,6*
  Foot and mouth disease            10 km /30 days      10 km /30 days    10 km /30 days       10 km /30 days     10 km /30 days    10 km /30 days       10 km /30 days
  Infection with Rift Valley fever                       150 km / 30
                                      150 km / 30 days                   150 km / 30 days           NA           150 km / 30 days  150 km / 30 days     150 km / 30 days
  virus                                                      days
  Infection with Mycoplamsma
  mycoides subsp. Mycoides SC
                                       10 km /30 days         NA               NA                   NA                  NA                NA             10 km /30 days
  (Contagious bovine
  pleuropneumonia)
  Infection with Peste des petits
                                            NA          10 km /30 days    10 km /30 days            NA            10 km /30 days    10 km /30 days            NA
  ruminants virus
  Sheep pox and goat pox                    NA          10 km /30 days    10 km /30 days            NA                  NA                NA                  NA
  Contagious caprine
                                            NA          10 km /30 days    10 km /30 days            NA                  NA                NA             10 km /30 days
  pleuropneumonia
  African swine fever                       NA                NA               NA             10 km /12 months          NA                NA                  NA
  Classical swine fever                     NA                NA               NA             10 km /12 months          NA                NA                  NA
  Infection with lumpy skin disease
                                      150 km / 30 days        NA               NA                   NA                  NA                NA                  NA
  virus
  Infection with bluetongue virus     150 km / 30 days   150 km / 30     150 km / 30 days           NA           150 km / 30 days  150 km / 30 days     150 km / 30 days
  (Serotypes 1-24)                                           days
  Infection with epizootic                               150 km / 30
                                      150 km / 30 days                   150 km / 30 days           NA           150 km / 30 days  150 km / 30 days     150 km / 30 days
  haemorrhagic disease virus                                 days
  Infection with Aujeszky’s disease
                                            NA                NA               NA            5 km /12 months **         NA                NA                  NA
  virus
  *           only applicable for listed species in accordance with the Annex to Commission Implementing Regulation (EU) 2018/1882
  **          in addition, a virology and serology test must be carried out to rule out the presence of the disease 30 days prior to dispatch to the Union
EN                                                                                        33                                                                                EN
 ---pagebreak---   NA = not applicable
EN                    34 EN
 ---pagebreak---   PART C
  Minimum periods of disease freedom of the third country or territory or zone thereof where the confined establishemnt of origin is located for
  ungulates intended for confined establishments in the Union:
                                                                                                                                          7. Ungulates others than
                                      1.Bovine         2. Ovine       3. Caprine       4. Porcine       5. Camelid         6. Cervid
                                                                                                                                        those referred to in columns
                                      animals          animals          animals         animals          animals            animals
                                                                                                                                                 1,2,3,4,5,6*
  Foot and mouth disease            12 months**      12 months**     12 months**        12 m**         12 months**       12 months**            12 months**
  Infection with rinderpest virus    12 months        12 months       12 months        12 months        12 months         12 months               12 months
  Infection with Rift Valley
                                    48 months**      48 months**     48 months**           NA          48 months**       48 months**            48 months**
  fever virus
  African swine fever                   NA                NA              NA         12 months**            NA                NA                     NA
  Classical swine fever                 NA                NA              NA         12 months**            NA                NA                     NA
  Infection with Brucella
  abortus, B. melitensis and B.    12 months **     12 months **     12 months **    12 months **     12 months **      12 months **            12 months **
  suis
  Infection with bluetongue
  virus (Serotypes 1-24)            24 months**      24 months**     24 months**           NA          24 months**       24 months**            24 months**
  Infection with epizootic
  haemorrhagic disease virus        24 months**      24 months**     24 months**           NA          24 months**       24months**             24 months**
  *        only applicable for listed species in accordance with the Annex to Commission Implementing Regulation (EU) 2018/1882
  **       or alternative guarantees are provided by the competent authority of the third country or territory according to Part DNA = not applicable
EN                                                                                    35                                                                             EN
 ---pagebreak---   PART D
  Alternative guarantees to be provided by the competent authority of the third country or territory as regards certain listed diseases
  Foot and mouth         (a)   the animals must have undergone a serological test for evidence of foot and mouth disease virus infection carried out in accordance with one of
  disease                      the prescribed tests for international trade laid down in the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (OIE Terrestrial
                               Manual), with negative results, on samples taken within a period of 10 days prior to the date of dispatch to the Union; and
                         (b) for Bovidae, Cervidae and Elephas spp.: a probang test for evidence of foot and mouth disease virus infection carried out in accordance with the
                               procedures laid down in the OIE Terrestrial Manual, with negative results. The test must have been carried out:
                                    (i) 10 days prior to the date of dispatch to the Union, for species other than African buffalo (Syncerus caffer);
                                    (ii) on two occasions 15 days at least apart, the second of which must have been taken during the period of 10 days prior to the date of
                                          dispatch to the Union, for African buffalo (Syncerus caffer).
  Infection with Rift    (a) the animals must:
  Valley fever virus                (i) have been kept in quarantine in a vector-protected facility in the approved confined establishment for a period of at least 30 days prior to
                                          the date of dispatch to the Union;
                                    (ii) have showed no disease symptoms of infection with Rift valley fever virus for a period of at least 30 days prior to the date of dispatch to
                                          the Union;
                                    (iii) have been protected from vectors when transported between the vector-protected facility referred to in point (i) and loading for dispatch
                                          to the Union; and
                         (b) the animals have undergone a virus neutralisation test with negative results for evidence of infection with Rift valley fever virus in accordance
                               with the OIE Terrestrial Manual, carried out firstly on samples taken at the date of commencement of the quarantine period and secondly on
                               samples taken at least 42 days from that that date and and during a period of 10 days prior to the dispatch to the Union.
  African swine fever    The animals have undergone a virology and serology test for the detection of African swine fever and classical swine fever in accordance with the
                         test prescribed for international trade in the OIE Terrestrial Manual, carried out on samples taken during the period of 30 days prior to the date of
  Classical swine fever  dispatch to the Union.
  Infection with         The animals:
  Brucella abortus, B.   (a) have undergone a test as laid down and prescribed for international trade by the OIE Terrestrial Manual, on samples taken during the period of the
                               30 days prior to the date of dispatch to the Union, or
  melitensis and B. suis
                         (b) they are castrated males of any age.
  Infection with         The       animals        must      comply        with     the      requirements      set    out      in      one      of     the     following       points:
  bluetongue virus       (a)        they have been kept in quarantine in a vector-protected facility in the confined establishment for a period of at least 30 days prior to the date
  (Serotypes 1-24)       of dispatch to the Union and have undergone a serology test for infection with bluetongue virus (1-24) and infection with epizootic haemorrhagic
                         disease virus carried out in accordance with the OIE Terrestrial Manual with negative results, carried out at least 28 days after the introduction of the
  Infections with        animals into the confined establishment;
  epizootic              (b)        they have been kept in quarantine in a vector-protected facility in the approved confined establishment for a period of at least 30 days prior to
  haemorrhagic           the date of dispatch to the Union and have undergone a PCR test for infection with bluetongue virus (1-24) and infection with epizootic haemorrhagic
  disease virus          disease virus in accordance with the OIE Terrestrial Manual, with negative results, carried out at least 14 days after the introduction into the confined
                         establishment;
                         (c)        they come from a seasonally disease-free area and have undergone during that disease-free period a serology test for infection with
                         bluetongue virus (1-24) and infection with epizootic haemorrhagic disease virus according to the OIE Terrestrial Manual, with negative results, carried
EN                                                                                                  36                                                                                EN
 ---pagebreak---    out on samples taken at least 28 days after introduction of the animals into the confined establishment;
   (d)        they come from a seasonally free area and have undergone during that period a PCR test for infection with bluetongue virus (1-24) and
   infection with epizootic haemorrhagic disease virus in accordance with the OIE Terrestrial Manual, with negative results, carried out on samples taken
   at least 14 days after the introduction of the animals into the approved confined establishment.
EN                                                                            37                                                                          EN
 ---pagebreak---   PART E
  Requirements as regards the absence of vaccination against certain diseases for the third country or territory of origin or zone thereof and for the
  ungulates intended for confined establishments:
                                                                                                                                     7. Ungulates
                                                                                                                                      others than
                                     1. Bovine        2. Ovine     3. Caprine     4. Porcine       5. Camelid        6. Cervid
                                                                                                                                   those referred to
                                      animals         animals       animals         animals         animals           animals         in columns
                                                                                                                                     1,2,3,4,5,6*
  Foot and mouth disease                NVA             NVA           NVA            NVA              NVA               NVA              NVA
  Infection with Rift Valley
  fever virus
                                      NVA**           NVA**         NVA**             NA            NVA**             NVA**            NVA**
  Classical swine fever                 NA               NA            NA            NVA               NA               NA                NA
  Infection with Brucella
  abortus, B. melitensis and B.       NVA**           NVA**         NVA**           NVA**           NVA**             NVA**            NVA**
  suis
  Infection with Aujeszky’s
  disease virus
                                        NA               NA            NA            NVA               NA               NA                NA
  NVA = the ungulates intended to the Union have not been vaccinated
  NA = not applicable
  *          only applicable for listed species in accordance with Commission Implementing Regulation (EU) 2018/1882
  **         or alternative guarantees are provided by the competent authority of the third country or territory according to Part D of this Annex
EN                                                                                   38                                                                EN
 ---pagebreak---    PART F
   Requirements for the vector-protected            facility in confined establishments in third
   countries
   Where required in Part D of this Annex, the vector-protected facility in the confined
   establishments in third countries or territories must comply with the following requirements:
   (a)      has appropriate physical barriers at entry and exit points;
   (b)      the openings of the vector-protected facility must be vector-screened with mesh of
            appropriate gauge, impregnated regularly with an approved insecticide according to
            the instructions of the manufacturer;
   (c)      vector surveillance and control must be carried out within and around the vector-
            protected facility;
   (d)      measures must be taken to limit or eliminate breeding sites for vectors in the vicinity
            of the vector-protected facility;
   (e)      standard operating procedures must be in place, including descriptions of back-up
            and alarm systems, for the operation of the vector-protected facility and for the
            transport of the animals from that structure to the place of loading for dispatch to the
            Union.
EN                                                  39                                               EN
 ---pagebreak---                                            ANNEX XIII
       MINIMUM REQUIREMENTS FOR VACCINATION PROGRAMMES AND
      ADDITIONAL SURVEILLANCE CARRIED OUT IN A THIRD COUNTRY OR
        TERRITORY OR ZONE THEREOF VACCINATING AGAINST HIGHLY
                             PATHOGENIC AVIAN INFLUENZA
   1.    Minimum requirements for vaccination programmes carried out in a third
         country or territory or zone thereof
         Vaccination programmes against highly pathogenic avian influenza submitted by a
         third country or territory must include at least the following information:
         (1)   objectives of the vaccination strategy, selected bird population(s) and area;
         (2)   data on the epidemiological evolution of the disease, including previous
               outbreaks in poultry or wild birds;
         (3)   description of the reasons for the decision to introduce the vaccination;
         (4)   risk assessment based on:
               –      highly pathogenic avian influenza outbreaks within that third country or
                      territory or zone thereof;
               –      highly pathogenic avian influenza outbreak in a neighbouring country;
               –      other risk factors such as certain areas, type of poultry husbandry or
                      categories of poultry or captive birds;
         (5)   geographical area where vaccination is carried out;
         (6)   number of establishments in vaccination area;
         (7)   number of establishments where vaccination is carried out, if different from the
               number in point 6;
         (8)   species and categories of poultry or captive birds in the geographical area
               where vaccination is carried out;
         (9)   approximate number of poultry or captive birds in the establishments referred
               to in point 7;
         (10) summary of the vaccine characteristics, authorisation and quality control;
         (11) handling, storage, supply, distribution and sale of avian influenza vaccines on
               the national territory;
         (12) implementation of a Differentiating Infected from Vaccinated Animals (DIVA)
               strategy;
         (13) envisaged duration of vaccination campaign;
         (14) provisions and restrictions on movements of vaccinated poultry and poultry
               products derived from vaccinated poultry or vaccinated captive birds;
         (15) clinical and laboratory tests, such as efficacy and pre-movement testing, carried
               out in the establishments vaccinated or located in the vaccination area;
         (16) means of record keeping.
EN                                               40                                             EN
 ---pagebreak---    2. Additional surveillance in third countries or territories or zones thereof that
      carry out vaccination against highly pathogenic avian influenza
      Where vaccination is carried out in a third country or territory or zone thereof, all
      establishments where vaccination against highly pathogenic avian influenza is
      carried out must be required to undergo laboratory testing and the following
      information must be submitted to the Commission, in addition to the information
      referred to in Annex II:
      (1)   number of vaccinated establishments in the area per category;
      (2)   number of vaccinated establishments to be sampled per poultry category;
      (3)   use of sentinel birds (namely, the species and number of sentinel birds used per
            epidemiological unit);
      (4)   number of samples taken per establishment and/or epidemiological unit;
      (5)   data on vaccine efficacy.
EN                                          41                                               EN
 ---pagebreak---                                           ANNEX XIV
      ANIMAL HEALTH REQUIREMENTS FOR RATITES, HATCHING EGGS
      THEREOF AND FRESH MEAT OF RATITES ORIGINATING IN A THIRD
   COUNTRY OR TERRITORY OR ZONE THEREOF NOT FREE FROM INFECTION
                           WITH NEWCASTLE DISEASE VIRUS
   1.   Breeding ratites, productive ratites and ratites intended for slaughter originating in a
        third country or territory or zone thereof not free from infection with Newcastle
        disease virus must:
        (a)    have been placed under official surveillance for a period of at least 21 days
               prior to the date of dispatch of the consignment for entry into the Union;
        (b)    have been kept in complete isolation during the period referred to in point (a),
               away from direct or indirect contact with other birds, in facilities approved by
               the competent authority of the third country or territory of origin for this
               purpose;
        (c)    have undergone a virus detection test for infection with Newcastle disease
               virus;
        (d)    come from flocks in which surveillance for infection with Newcastle disease
               virus was carried out under a statistically-based sampling plan which produced
               negative results for a period of at least 6 months immediately prior to the date
               of dispatch of the consignment for entry into the Union.
   2.   Day-old chicks of ratites and hatching eggs of ratites originating in a third country or
        territory or zone thereof not free from infection with Newcastle disease virus, must
        come from flocks:
        (a)    which were placed in isolation under official surveillance for a period of at
               least 30 days prior to the date of laying of the hatching eggs intended for entry
               into the Union or of the hatching eggs from which the day-old chicks destined
               for entry into the Union are derived;
        (b)    which underwent a virus detection test for infection with Newcastle disease
               virus;
        (c)    where surveillance for infection with Newcastle disease virus was carried out
               under a statistically-based sampling plan which produced negative results for a
               period of at least 6 months immediately prior to the date of dispatch of the
               consignment for entry to the Union;
        (d)    which were not in contact with poultry which do not fulfil the guarantees under
               points (a), (b) and (c) during the period of 30 days prior to the date of laying
               and during the laying of the hatching eggs intended for entry into the Union or
               of the hatching eggs from which the day-old chicks destined for entry into the
               Union are derived.
   3.   Fresh meat of ratites originating in a third country or territory or zone thereof not free
        from infection with Newcastle disease virus must:
        (a)    be de-boned and skinned;
        (b)    come from ratites which for a period of at least 3 months prior to the date of
               slaughter were kept on establishments:
EN                                               42                                                EN
 ---pagebreak---             (i)    on which there was no outbreak of infection with Newcastle disease virus
                   or highly pathogenic avian influenza during the 6 months prior to the
                   date of slaughter;
            (ii)   around which there were no outbreaks of highly pathogenic avian
                   influenza or infection with Newcastle disease virus for a period of at
                   least 3 months prior to the date of slaughter within 10 km of the
                   perimeter of the part of the establishment containing the ratites,
                   including, where appropriate, the territory of a neighbouring Member
                   State or third country;
            (iii) on which surveillance for infection with Newcastle disease virus was
                   carried out under a statistically-based sampling plan, which produced
                   negative results for a period of at least 6 months prior to the date of
                   slaughter.
      (c)   have undergone surveillance as referred to in point (b)(iii):
            (i)    by serology, in the case of ratites not vaccinated against infection with
                   Newcastle disease virus;
            (ii)   by tracheal swabs of ratites, in the case of ratites vaccinated against
                   infection with Newcastle disease virus;
      (d)   come from ratites which, if vaccinated against infection with Newcastle disease
            virus, were not vaccinated with vaccines that did not meet the specific criteria
            set out in Part 1 of Annex XV during the period of 30 days prior to the date of
            slaughter.
   4. The virus detection testing provided for in paragraphs 1(c) and 2(b) must have been
      carried out:
      (a)   within 7 to 10 days of the date the ratites entered isolation;
      (b)   on cloacal swabs or faeces samples from each bird.
   5. The virus detection testing provided for in paragraphs 1(c) and 2(b) must have shown
      that no avian paramyxovirus type 1 isolates with an Intracerebral Pathogenicity Index
      (ICPI) of more than 0.4 were found. In addition, favourable results must have been
      available from all birds in the consignment before:
      (a)   breeding ratites, productive ratites or ratites intended for slaughter left the
            facilities referred in 1(b) for dispatch to the Union;
      (b)   day-old chicks left the hatchery for dispatch to the Union;
      (c)   hatching eggs were loaded for dispatch to the Union.
EN                                             43                                            EN
 ---pagebreak---                                             ANNEX XV
         CRITERIA FOR VACCINES AGAINST INFECTION WITH NEWCASTLE
     DISEASE VIRUS AND REQUIREMENTS FOR CONSIGNMENTS OF POULTRY,
      HATCHING EGGS AND FRESH MEAT OF POULTRY ORIGINATING FROM A
        THIRD COUNTRY OR TERRITORY OR ZONE THEREOF VACCINATING
               AGAINST INFECTION WITH NEWCASTLE DISEASE VIRUS
   1.      Criteria for vaccines against infection with Newcastle disease virus
   1.1.    General criteria
           (a)   Vaccines must comply with the standards set out in the chapter on Newcastle
                 disease in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals
                 of the World Organisation for Animal Health (OIE).
           (b)   Vaccines must be registered by the competent authorities of the third country
                 or territory of origin concerned before being allowed to be distributed and
                 used. For such registration, the competent authorities of the third country or
                 territory of origin concerned must rely on a complete file submitted by the
                 applicant containing data on the efficacy and innocuity of the vaccine. In the
                 case of imported vaccines, the competent authorities of the third country or
                 territory of origin may rely on data checked by the competent authorities of the
                 country where the vaccine is produced, insofar as these checks have been
                 carried out in conformity with OIE standards.
           (c)   In addition to the requirements set out in points (a) and (b), imports or the
                 production and distribution of the vaccines must be controlled by the
                 competent authorities of the third country or territory of origin concerned.
           (d)   Before distribution of the vaccines is allowed, each batch of vaccines must be
                 tested on innocuity, in particular regarding attenuation or inactivation and
                 freedom from extraneous agents, and on efficacy. The testing is performed
                 under the control of the competent authorities of the third country or territory
                 of origin.
   1.2.    Specific criteria
           Live attenuated vaccines against infection with Newcastle disease virus must be
           prepared from a Newcastle disease virus strain for which the master seed has been
           tested and shown to have an ICPI of either:
           (a)   less than 0,4, if not less than 107 EID50 are administered to each bird in the
                 ICPI test;
                 or
           (b)   less than 0,5, if not less than 108 EID50 are administered to each bird in the
                 ICPI test.
   2.      Animal health requirements 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
           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 1.2 must meet the requirements set out
           below:
EN                                               44                                               EN
 ---pagebreak---       (a)   poultry and the flocks of origin of hatching eggs must not have been vaccinated
            with such vaccines for a period of at least 12 months prior to the date the
            consignment is loaded for dispatch to the Union;
      (b)   the flocks of origin of poultry and of hatching eggs must have undergone a
            virus isolation test for infection with Newcastle disease virus not earlier than 2
            weeks prior to the date of loading of the consignment for dispatch to the Union
            or, in the case of hatching eggs, not earlier than 2 weeks prior to the date the
            eggs were collected. The test must have been carried out in an official
            laboratory on a random sample of cloacal swabs taken from at least 60 birds in
            each flock, and no avian paramyxoviruses with an ICPI of more than 0.4 have
            been found;
      (c)   poultry and the flocks of origin of hatching eggs must have been kept in
            isolation under official surveillance on the establishment of origin during the
            two-week period referred to in point (b);
      (d)   poultry and the flocks of origin of hatching eggs must not have been in contact
            with poultry not meeting the requirements set out in points (a) and (b):
            (i)    in the case of poultry, during the period of 60 days prior to the date the
                   consignment was loaded for dispatch to the Union;
            (ii)   in the case of hatching eggs, during the period of 60 days prior to the date
                   the eggs were collected;
      (e)   day-old chicks and the hatching eggs from which the day-old chicks are
            derived must not have been in contact in the hatchery or during transport to the
            Union with poultry or hatching eggs not meeting the requirements set out in
            points (a) to (d).
   3. Animal health requirements for fresh meat of poultry 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
      Fresh meat of poultry 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 1.2 must originate from poultry that meet the
      following health requirements:
      (a)   the poultry have not been vaccinated with live attenuated vaccines prepared
            from an infection with Newcastle disease virus master seed showing a higher
            pathogenicity than lentogenic strains of the virus within the period of 30 days
            prior to the date of slaughter;
      (b)   the poultry underwent a virus isolation test for infection with Newcastle
            disease virus, carried out in an official laboratory at the time of slaughter on a
            random sample of cloacal swabs from at least 60 birds in each flock concerned,
            and in which no avian paramyxoviruses with an ICPI of more than 0,4 were
            found;
      (c)   the poultry have not been in contact during the period of 30 days prior to the
            date of slaughter with poultry that does not fulfil the conditions set out in
            points (a) and (b).
EN                                            45                                                EN
 ---pagebreak---    4. Information to be provided when flocks of origin of poultry, flocks of origin of
      hatching eggs and hatching eggs are vaccinated against infection with Newcastle
      disease virus
      Where the flocks of origin of poultry, the flocks of origin of hatching eggs or
      hatching eggs are vaccinated against infection with Newcastle disease virus, the
      following information must be provided for the consignment:
      (a)   identification of the flock;
      (b)   age of the birds;
      (c)   date of vaccination;
      (d)   name and type of virus strain used;
      (e)   batch number of the vaccine;
      (f)   name of the vaccine;
      (g)   manufacturer of the vaccine.
EN                                         46                                          EN
 ---pagebreak---                                            ANNEX XVI
     REQUIREMENTS AS REGARDS THE INFORMATION TO BE MENTIONED ON
      THE CONTAINERS OF POULTRY, CAPTIVE BIRDS AND HATCHING EGGS
   1.     Breeding poultry and productive poultry must be transported in containers which
          bear the following indications:
          (a)   the name and ISO code of the third country or territory of origin;
          (b)   the species of poultry concerned;
          (c)   the number of animals;
          (d)   the category and type of production for which they are intended;
          (e)   the name, address and approval number of the establishment of origin;
          (f)   the name of the Member State of destination.
   2.     Poultry intended for slaughter must be transported in containers which bear the
          following indications:
          (a)   the name and ISO code of the third country or territory of origin;
          (b)   the species of poultry concerned;
          (c)   the number of animals;
          (d)   the category and type of production for which they are intended;
          (e)   the name, address and registration number of the establishment of origin;
          (f)   the name of the Member State of destination.
   3.     Day-old chicks must be transported in containers which bear the following
          indications:
          (a)   the name and ISO code of the third country or territory of origin;
          (b)   the species of poultry concerned;
          (c)   the number of animals;
          (d)   the category and type of production for which they are intended;
          (e)   the name, address and approval number of the establishment of origin of the
                day-old chicks;
          (f)   the approval number of the establishment of origin of the flock of origin;
          (g)   the name of the Member State of destination.
   4.     Captive birds must be transported in containers which bear the following indications:
          (a)   the name and ISO code of the third country or territory of origin;
          (b)   the number of animals;
          (c)   the name, address and approval number of the establishment of origin;
          (d)   the specific identification number of the container;
          (e)   the name of the Member State of destination.
   5.     Hatching eggs of poultry must be transported in containers which bear the following
          indications:
EN                                              47                                              EN
 ---pagebreak---       (a)   the word ‘hatching’;
      (b)   the name and ISO code of the third country or territory of origin;
      (c)   the species of poultry concerned;
      (d)   the number of eggs;
      (e)   the category and type of production for which they are intended;
      (f)   the name, address and approval number of the establishment of origin of the
            eggs;
      (g)   the approval number of the establishment of origin of the flock of origin, if
            different from point (f);
      (h)   the name of the Member State of destination.
   6. Specified pathogen-free eggs must be transported in containers which bear the
      following indications:
      (a)   the wording ‘SPF eggs for diagnostic, research or pharmaceutical use only’;
      (b)   the name and ISO code of the third country or territory of origin;
      (c)   the number of eggs;
      (d)   the name, address and approval number of the establishment of origin;
      (e)   the name of the Member State of destination.
   7. Hatching eggs of captive birds must be transported in containers which bear the
      following indications:
      (a)   the name and ISO code of the third country or territory of origin;
      (b)   the number of eggs;
      (c)   the name, address and approval number of the establishment of origin;
      (d)   the specific identification number of the container;
      (e)   the name of the Member State of destination.
EN                                          48                                            EN
 ---pagebreak---                                               ANNEX XVII
       REQUIREMENTS FOR TESTING OF CONSIGNMENTS OF LESS THAN 20
    HEADS OF POULTRY OTHER THAN RATITES AND LESS THAN 20 HATCHING
                 EGGS THEREOF BEFORE THEIR ENTRY INTO THE UNION
   Consignments of less than 20 heads of poultry other than ratites or less than 20 hatching eggs
   of poultry other than ratites must have been tested negative for the diseases referred to in
   point (e) of Article 49 and point (e)(ii) of Article 110 as follows:
   (a)       in the case of breeding poultry, productive poultry and poultry intended for slaughter
             other than ratites, the animals must have been tested negative in serological and/or
             bacteriological tests within the period of 30 days prior to the date of loading of the
             consignment for dispatch to the Union;
   (b)       in the case of hatching eggs of poultry other than ratites and day-old chicks other
             than ratites, the flock of origin must have tested negative in serological tests and/or
             bacteriological tests within the period of 90 days prior to the date of loading of the
             consignment for dispatch to the Union at a level which gives 95% confidence of
             detecting infection at 5% prevalence;
   (c)       where the animals have been vaccinated against infection with any serotype of
             Salmonella or Mycoplasma, only bacteriological testing must be used, but the
             confirmation method must be capable of differentiating live vaccinal strains from
             field strains.
EN                                                  49                                               EN
 ---pagebreak---                                         ANNEX XVIII
    SAMPLING AND TESTING OF POULTRY OTHER THAN RATITES AFTER THE
                                ENTRY INTO THE UNION
   1.   The official veterinarian shall take samples for virological examination from
        breeding poultry other than ratites, productive poultry other than ratites and day-old
        chicks other than ratites which have entered into the Union from a third country or
        territory or zone thereof. The samples must be collected as follows:
        (a)    between the seventh and the fifteenth day following the date when the animals
               were placed in the establishments of destination in the Union, cloacal swabs
               must be taken at a level which gives a 95% confidence of detecting infection at
               5% prevalence;
        (b)    testing of samples must be carried out for:
               (i)   highly pathogenic avian influenza;
               (ii)  infection with Newcastle disease virus.
   2.   Samples may be pooled to a maximum of five samples from individual birds in each
        pool.
EN                                            50                                               EN
 ---pagebreak---                                            ANNEX XIX
      ANIMAL HEALTH REQUIREMENTS FOR GRANTING APPROVAL OF THE
                   ESTABLISHMENT OF ORIGIN OF CAPTIVE BIRDS
   1.    The animal health requirements in relation to biosecurity measures, as referred to in
         Article 56, are as follows:
         (a)   only animals coming from other approved establishments may be introduced
               into the establishment;
         (b)   birds may be introduced into the establishment from sources other than
               approved establishments after approval for such introduction is given by the
               competent authority of the third country or territory, provided that such animals
               are isolated for at least 30 days from the date they were introduced into the
               establishment, in accordance with the instructions given by the competent
               authority of the third country or territory, before being added to the collection
               of birds in the establishment.
   2.    The animal health requirements in relation to the facilities and equipment on the
         establishment, as referred to in Article 56, are as follows:
         (a)   the establishment must be clearly demarcated and separated from its
               surroundings;
         (b)   the establishment must have adequate means for catching, confining and
               isolating animals and have available adequate approved quarantine facilities
               and approved procedures for animals coming from establishments that have not
               been approved;
         (c)   the establishment must either have suitable arrangements or on-site facilities
               and equipment for the appropriate disposal of the bodies of animals which die
               of a disease or are euthanised.
   3.    The animal health requirements in relation to record keeping, as referred to in Article
         56, are as follows:
         (a)   the operator responsible for the establishment must keep up-to-date records
               indicating:
               (i)    the number and identity (namely the age, sex, species and individual
                      identification number where practical) of the animals of each species
                      present in the establishment;
               (ii)   the number and identity (namely the age, sex, species and individual
                      identification number where practical) of animals arriving in the
                      establishment or leaving it, together with information on their origin or
                      destination, the transport from or to the establishment and the animal
                      health status;
               (iii) the results of blood tests or any other diagnostic procedures;
               (iv) cases of disease and, where appropriate, the treatment administered;
               (v)    the results of the post-mortem examinations on animals that have died in
                      the establishment, including still-born animals;
               (vi) observations made during any isolation or quarantine period.
EN                                              51                                               EN
 ---pagebreak---       (b)   the operator responsible for the establishment must keep the records referred to
            in point (a) following the date of approval, for a period of at least 10 years.
   4. The animal health requirements in relation to personnel, as referred to in Article 56,
      are as follows:
      (a)   the person responsible for the establishment must have adequate ability and
            knowledge;
      (b)   the operator responsible for the establishment must secure, by contract or other
            legal instrument, the services of a veterinarian approved by and under the
            control of the competent authority of the third country or territory, who:
            (i)    ensures that appropriate disease surveillance and control measures in
                   relation to the disease situation of the third country or territory concerned
                   are approved by the competent authority and applied in the
                   establishment; such measures must include the following:
                   –      an annual disease surveillance programme including appropriate
                          zoonoses control of the animals;
                   –      clinical, laboratory and post-mortem testing of animals suspected to
                          be affected by diseases;
                   –      vaccination of susceptible animals against diseases as appropriate,
                          in conformity with the Terrestrial Animal Health Code and the
                          Manual of Diagnostic Tests and Vaccines for Terrestrial Animals
                          of the OIE;
            (ii)   ensures that any suspect deaths or the presence of any other symptoms
                   indicative of highly pathogenic avian influenza, infection with Newcastle
                   disease virus or avian chlamydiosis is notified without delay to the
                   competent authority of the third country or territory;
            (iii) ensures that animals entering the establishment have been isolated as
                   necessary and in accordance with the requirements of paragraph 1(b) and
                   with the instructions, if any, given by the competent authority of the third
                   country or territory;
   5. The animal health requirements in relation to health status, as referred to in Article
      56, are as follows:
      (a)   the establishment must be free from highly pathogenic avian influenza,
            infection with Newcastle disease virus and avian chlamydiosis; in order for the
            establishment to be declared free from those diseases, the competent authority
            of the third country or territory shall assess the records on the animal health
            status kept for a period of at least three years prior to the date of the application
            for approval and the results of the clinical and laboratory tests carried out on
            the animals therein. However, new establishments must only be approved
            based on the results of the clinical and laboratory tests carried out on the
            animals in such establishments;
      (b)   the operator responsible for the establishment must either have an arrangement
            with a laboratory to perform post-mortem examinations, or have one or more
            appropriate premises where such examinations may be performed by a
            competent person under the authority of a veterinarian approved for that
            purpose by the competent authority of the third country or territory.
EN                                             52                                                 EN
 ---pagebreak---                                            ANNEX XX
    EXAMINATION, SAMPLING AND TESTING PROCEDURES OF CAPTIVE BIRDS
    FOR HIGHLY PATHOGENIC AVIAN INFLUENZA AND NEWCASTLE DISEASE
   1.    During quarantine either the sentinel birds, or if sentinel birds are not used, the
         captive birds, shall must undergo the following procedures:
         (a)   cases involving the use of sentinel birds:
               (i)   blood samples for serological examination must be taken from all
                     sentinel birds within a period of not less than 21 days following the date
                     of their entry into the quarantine and within a period of at least 3 days
                     prior to the date of the end of the quarantine;
               (ii)  if sentinel birds show positive or inconclusive serological results for the
                     samples referred to in point (i):
                     –      the imported birds must undergo a virological examination;
                     –      cloacal swabs (or faeces) and tracheal or oropharyngeal swabs must
                            be taken from at least 60 birds, or from all birds if the consignment
                            is less than 60 birds;
         (b)   cases not involving the use of sentinel birds:
               –     imported birds must be examined virologically (i.e. serological testing is
                     not appropriate);
               –     tracheal or oropharyngeal or cloacal swabs (or faeces) must be taken
                     from at least 60 birds, or from all birds if the consignment is less than 60
                     birds, during the period of the first 7 to 15 days of the quarantine.
   2.    In addition to the testing set out in point 1, the following samples must be taken for
         virological examination:
         (a)   cloacal swabs (or faeces) and tracheal or oropharyngeal swabs, if possible,
               from clinically ill birds or ill sentinel birds;
         (b)   from the intestinal contents, brain, trachea, lungs, liver, spleen, kidneys and
               other obviously affected organs as soon as possible following death, from:
               (i)   dead sentinel birds and all birds dead on arrival in quarantine and those
                     which die during quarantine; or
               (ii)  in the case of high mortality in large consignments made of small birds,
                     from at least 10% of the dead birds.
   3.    For virological examination, pooling of samples up to a maximum of five samples of
         individual birds in one pool is allowed.
         Faecal material must be pooled separately from other organ and tissue samples.
EN                                                53                                              EN
 ---pagebreak---                                          ANNEX XXI
      SPECIFIC REQUIREMENTS AS REGARDS DOGS, CATS AND FERRETS
                       INTENDED FOR ENTRY INTO THE UNION
   1.   ANTIBODY RABIES TITRATION TEST REQUIREMENTS:
        (a)   must be carried out on a sample collected by a veterinarian authorised by the
              competent authority during the period commencing at least 30 days after the
              date of the primary vaccination, within a current valid vaccination series, and
              ending 3 months before the date of issue of the certificate;
        (b)   must measure a titre of neutralising antibody to rabies virus equal to or greater
              than 0,5 IU/ml;
        (c)   must be certified by an official report from the official laboratory as regards the
              result, and a copy of this report must be attached to the animal health certificate
              accompanying the animals to the Union;
        (d)   does not have to be renewed on an animal which, following the antibody rabies
              titration test with satisfactory results, has been revaccinated against rabies
              within the period of validity of the primary vaccination referred to in point (a)
              and all subsequent valid vaccinations in the series.
   2.   TREATMENT            AGAINST         INFESTATION           WITH        ECHINOCCOCUS
        MULTILOCULARIS
        Prior to entry into the Union, dogs must be treated against infestation with
        Echinococcus multilocularis, as follows:
        (a)   the treatment must consist of an approved veterinary medicinal product which
              contains the appropriate dose of praziquantel or pharmacologically active
              substances which alone or in combination have proven to reduce the burden of
              mature and immature intestinal forms of Echinococcus multilocularis in the
              host species concerned;
        (b)   the product must be administered by a veterinarian within a period
              commencing not more than 48 hours and ending not less than 24 hours before
              the time of arrival in the Union;
        (c)   the following details of the treatment must be certified by the administering
              veterinarian in the animal health certificate referred to in Article 3(1)(c)(i):
              (i)    the transponder or tattoo alphanumeric code of the dog, cat or ferret;
              (ii)   the name of the product against infestation with Echinococcus
                     multilocularis;
              (iii) the name of the manufacturer of the product;
              (iv) the date and time of treatment;
              (v)    the name, stamp and signature of the administering veterinarian.
EN                                             54                                                 EN
 ---pagebreak---                                        ANNEX XXII
     REQUIREMENTS AS REGARDS THE RESIDENCY PERIODS OF HATCHING
                    EGGS BEFORE THE ENTRY INTO THE UNION
                                                                          Minimum period
                                 Minimum                                  without contact
                            residency period in  Minimum residency         with poultry or
                 Minimum
                             the third country        period in the       hatching eggs of
    Category of  residency
                               or territory of     establishment of     lower health status,
   hatching eggs   period
                               origin or zone    origin, as referred to   captive birds or
                 applies to
                            thereof, as referred    in Article 98(b)        wild birds as
                              in Article 98(a)                             referred to in
                                                                            Article 98(c)
     Hatching
                  Flock of
      eggs of                    3 months               6 weeks               6 weeks
                   origin
      poultry
   Consignments
    of less than
    20 hatching   Flock of
                                 3 months               3 weeks                3 week
      eggs of      origin
   poultry other
    than ratites
EN                                            55                                             EN
 ---pagebreak---                                            ANNEX XXIII
         REQUIREMENTS AS REGARDS THE RESIDENCY PERIOD BEFORE
      SLAUGHTER OR KILLING OF THE KEPT UNGULATES OF ORIGIN OF THE
                                          FRESH MEAT
   1.     The period during which the ungulates must have remained in the third country or
          territory of origin or zone thereof before the date of slaughter or killing, as referred to
          in Article 131(2)(a), must be either:
          (a)    at least 3 months prior that date; or
          (b)    less than 3 months prior to that date, if the ungulates are less than 3 months of
                 age.
   2.     Kept ungulates must have remained in their establishment of origin without having
          come into contact with ungulates of a lower health status, as referred to in Article
          131(2)(b) and (c), for at least the 40 days prior to the date of slaughter or killing,
          where such animals:
          (a)    originate from a third country, territory or zone thereof which applies one or
                 more of the specific conditions set out in Part B of Annex XXIV;
          (b)    are covered by the derogation provided for in Article 132.
EN                                                56                                                  EN
 ---pagebreak---                                                                             ANNEX XXIV
         DISEASE FREEDOM IN THE THIRD COUNTRY OR TERRITORY OF ORIGIN OF THE PRODUCTS OF ANIMAL ORIGIN
  Part A
  Minimum periods (in months) of disease freedom of the third country or territory of origin or zone thereof in accordance with Article 133(1).
                                                                                                                                                7. Ungulates other
                                         1. Bovine         2. Ovine       3. Caprine      4. Porcine        5. Camelid          6. Cervid       than those referred
                                          animals           animals        animals          animals           animals            animals           to in columns
                                                                                                                                                    1,2,3,4,5,6*
  Foot and mouth disease                  12 m**            12 m**          12 m**          12 m**             12 m**            12 m**               12 m**
  Infection with rinderpest virus          12 m              12 m            12 m            12 m               12 m              12 m                  12 m
  African swine fever                       NA                NA              NA             12 m                NA                NA                    NA
  Classical swine fever                     NA                NA              NA            12 m**               NA                NA                    NA
  *         only applicable to listed species in accordance with Annex to Commission Implementing Regulation (EU) 2018/1882
  **        this period may be reduced where specific conditions, in accordance with Part B, are provided by the competent authority of the third country or territory
  NA = not applicable
  Part B
  Specific conditions to be provided by the competent authority where the third country or territory or zone thereof has been free of the disease for a period of less than
  12 months as provided for in the derogation laid down in Article 133(1):
    Foot and mouth disease
                                   Supplementary information to guarantee the determination of a date from which the third country or territory or zone thereof is
                                                                                considered free from the disease
     Classical swine fever
EN                                                                                 57                                                                                     EN
 ---pagebreak---                                                                             ANNEX XXV
                VACCINATION IN THE THIRD COUNTRY OR TERRITORY OF ORIGIN OR ZONE THEREOF AND IN THE
                     ESTABLISHMENT OF ORIGIN OF THE ANIMALS FROM WHICH THE FRESH MEAT IS OBTAINED
  Part A
  Animal health requirements regarding the absence of vaccination in the third country or territory of origin or zone thereof and in the
  establishment of origin of the ungulates from which the fresh meat is obtained:
                                                                                                                                     7. Ungulates
                                                                                                                                   other than those
                                     1. Bovine        2. Ovine       3. Caprine     4. Porcine     5. Camelid       6. Cervid
                                                                                                                                     referred to in
                                      animals         animals         animals        animals        animals          animals            columns
                                                                                                                                      1,2,3,4,5,6*
      Foot and mouth disease        NV/NVE**        NV/NVE**        NV/NVE**        NV/NVE        NV/NVE**         NV/NVE**          NV/NVE**
   Infection with rinderpest virus  NV/NVE**        NV/NVE**        NV/NVE**        NV/NVE        NV/NVE**         NV/NVE**          NV/NVE**
        African swine fever              NA              NA              NA         NV/NVE             NA              NA                 NA
        Classical swine fever            NA              NA              NA         NV/NVE             NA              NA                 NA
  NV = for a period of at least 12 months prior to the date of dispatch to the Union: no vaccination has been carried out in the third country or territory or zone
  thereof and there have been no entries of vaccinated animals in the third country territory or zone
  NVE = no vaccinated animals in the establishment of origin of the ungulates from which the fresh meat is obtained
  NA = not applicable
  *          only applicable for listed species in accordance with Annex to Commission Implementing Regulation (EU) 2018/1882
  **         or specific conditions, in accordance with Part B, are provided by the competent authority of the third country or territory
EN                                                                                    58                                                                            EN
 ---pagebreak---    Part B
   Specific conditions to be provided by the competent authorities where vaccination
   against foot and mouth disease has been carried out in the third country or territory or
   zone thereof for a period of less than 12 months as referred to in Article 133(3)
   1.       FROM     A THIRD COUNTRY, TERRITORY OR ZONE THEREOF WHICH IS FREE FROM
            FOOT AND MOUTH DISEASE AND WHERE VACCINATION AGAINST FOOT AND MOUTH
            DISEASE STRAINS A, O OR C IS PRACTISED
            The competent authority of the third country or territory of origin must provide
            supplementary information to guarantee the absence of foot and mouth disease virus
            in fresh meat and compliance with the following requirements:
            (a)    a vaccination programme against foot and mouth disease is carried out in kept
                   bovine animals and controlled by the competent authority of the third country
                   or territory of origin;
            (b)    the fresh meat is obtained from either:
                   (i)    bovine, ovine and caprine animals that originate from establishments in
                          and around which, in an area with a 25 kilometres radius, foot and mouth
                          disease or rinderpest have not been reported during the 60 days prior to
                          the date of dispatch to the slaughterhouse;
                   or
                   (ii)   kept ungulates of listed species other than bovine, ovine, caprine and
                          porcine that originate from establishments in and around which in an area
                          of 50 kilometres radius, foot and mouth disease or rinderpest have not
                          been reported during the 90 days prior to the date of dispatch to the
                          slaughterhouse;
                   or
                   (iii) wild ungulates that comply with the requirements laid down in Article
                          138;
            (c)    the meat is de-boned fresh meat other than offal that was obtained from
                   carcasses:
                   (i)    in which the main accessible lymph nodes have been removed;
                   (ii)   which have been submitted to maturation at a temperature above +2°C
                          for at least 24 hours before the bones were removed;
                   (iii) in which the pH value of the meat was below 6,0 when tested
                          electronically in the middle of the longissimus-dorsi muscle after
                          maturation and before de-boning.
   2.       FROM     A THIRD COUNTRY, TERRITORY OR ZONE THEREOF WHICH IS FREE FROM
            FOOT AND MOUTH DISEASE AND WHERE VACCINATION AGAINST FOOT AND MOUTH
            DISEASE STRAINS A, O OR C IS PRACTISED AND IS SUBJECT TO ADDITIONAL
            SPECIFIC CONDITIONS
            In addition to the requirements set out in point 1, the competent authority of the third
            country or territory must comply with additional specific conditions in relation to the
EN                                                   59                                              EN
 ---pagebreak---         vaccination programme which support the absence of foot and mouth disease virus in
        fresh meat from the zone.
   3.   FOOT AND MOUTH DISEASE-FREE ZONES WHERE VACCINATION IS NOT PRACTISED
   3.1. Foot and mouth disease strains SAT or ASIA 1
        Where fresh meat originates from a foot and mouth disease-free zone where
        vaccination is not practised, but that zone is in a third country or territory in which
        vaccination against foot and mouth disease (FMD) strains SAT or ASIA 1 is
        practised in other zones or where those strains are endemic in part(s) of the third
        country or territory or in the neighbouring Member State or third countries, the
        competent authorities of a third country or territory of origin of such meat must
        provide the necessary supplementary information to guarantee the absence of the foot
        and mouth disease virus in the fresh meat and to guarantee compliance with the
        following animal health requirements:
        (a)   the fresh meat is obtained from either:
              (i)    kept animals of listed species that originate from establishments in and
                     around which, in an area of 10 kilometres radius, foot and mouth disease
                     or rinderpest have not been reported during the period of 12 months prior
                     to the date of slaughter;
              or
              (ii)   wild ungulates that comply with the requirements laid down in Article
                     138;
        (b)   the meat is not authorised for export to the Union until 21 days have elapsed
              following the date of slaughter;
        (c)   the meat is de-boned fresh meat other than offal, obtained from carcasses:
              (i)    in which the main accessible lymphnodes have been removed;
              (ii)   which have been submitted to maturation at a temperature above +2°C
                     for a period of at least 24 hours before the bones were removed.
   3.2. Foot and mouth disease strains A, O or C
        Where fresh meat originates in a foot and mouth free zone where vaccination against
        foot and mouth disease is not practised, but that zone is in a third country or territory
        in which vaccination against foot and mouth disease strains A, O or C is practised,
        and where the competent authorities of the third country or territory have provided
        additional guarantees on conditions specific for the third country or territory or zone
        and which support the absence of foot and mouth disease virus in the fresh meat from
        the zone, the competent authorities of the third country or territory of origin must
        provide the following supplementary information:
        (a)   guarantees that the surveillance programme for foot and mouth disease
              applicable for the free zone, demonstrating the absence of foot and mouth
              disease, is carried out and controlled by the competent authorities of the third
              country or territory of origin;
        (b)   guarantees on the application of the animal health requirements set out in
              points (b) and (c) of Point 1.
EN                                              60                                                EN
 ---pagebreak---                                           ANNEX XXVI
            RISK MITIGATING TREATMENTS FOR MEAT PRODUCTS
   1.   RISK    MITIGATING TREATMENTS FOR MEAT PRODUCTS LISTED IN DESCENDING
        ORDER OF SEVERITY:
   B  =    Treatment in a hermetically sealed container to a Fo value of three or more.
   C  =    A minimum temperature of 80°C, which must be reached throughout the meat product
           during its processing.
   D  =    A minimum temperature of 70°C, which must be reached throughout the meat or
           stomachs, bladders and intestines during the processing of meat products and treated
           stomachs, bladders and intestines, or for raw ham, a treatment consisting of natural
           fermentation and maturation of not less than nine months and resulting in the following
           characteristics:
           — Aw value of not more than 0,93;
           — pH value of not more than 6,0.
   D1 =    Thorough the cooking of meat, previously de-boned and defatted, subjected to heating so
           that an internal temperature of 70°C or greater is maintained for a minimum period of 30
           minutes.
   E  =    In the case of ‘biltong’-type products, a treatment to achieve:
           — Aw value of not more than 0,93;
           — pH value of not more than 6,0.
   F  =    A heat treatment ensuring that a core temperature of at least 65°C is reached for a period
           of time as necessary to achieve a pasteurisation value (Pv) equal to or above 40.
   2.   RISK MITIGATING TREATMENTS FOR CASINGS:
        Casing 1 = Salting with sodium chloride (NaCl), either dry or as saturated brine
        (aw < 0,80), for a continuous period of 30 days or longer, at a temperature of 20°C or
        above.
        Casing 2 = Salting with phosphate supplemented salt containing 86,5 % NaCl, 10,7
        % Na2HPO4 and 2,8% Na3PO4 (weight/weight/weight), either dry or as saturated
        brine (aw < 0.80), for a continuous period of 30 days or longer, at a temperature of
        20°C or above.
        Casing 3 = Salting with NaCl for 30 days
        Casing 4 = Bleaching
        Casing 5 = Drying after scraping.
EN                                               61                                                   EN
 ---pagebreak---                                          ANNEX XXVII
    RISK MITIGATING TREATMENTS FOR MILK AND DAIRY PRODUCTS
                                                               A                B
                                                      Bos Taurus, Ovis   Other than Bos
                                                         aries, Capra   Taurus, Ovis aries,
     Species of origin of the milk and the dairy       hircus, Bubalus    Capra hircus,
                        products                         bubalis and     Bubalus bubalis
                                                           Camelus        and Camelus
                                                        dromedarius       dromedarius
                                                     1. Third
                                                        countries not
                                                        officially free
                                                        of foot and
                                                        mouth (FMD)
                                                        for the
                                                        preceding 12
     Animal health status of the third country          months                Any
                                                     2. Third
                                                        countries
                                                        where
                                                        vaccination
                                                        against FMD is
                                                        practised
   Sterilisation process, to achieve an Fo value
                                                             Yes               Yes
   equal to or greater than 3
   Ultra-high temperature (UHT) treatment at not
   less than 135°C in combination with a suitable            Yes               Yes
   holding time
   High temperature short time pasteurisation
   treatment (HTST) at 72°C for 15 seconds
   applied twice to milk with a pH equal to or
   greater than 7,0 achieving, where applicable, a           Yes               No
   negative reaction to a alkaline phosphatase
   test, applied immediately after the heat
   treatment
   HTST treatment of milk with a pH below 7,0
                                                             Yes               No
   HTST treatment combined with another
   physical treatment by either:
    (i) lowering the pH below 6 for one hour, or             Yes               No
    (ii) additional heating equal to or greater than
         72 °C, combined with desiccation
    No: treatment not permitted
    Yes: acceptable treatment
EN                                                62                                        EN
 ---pagebreak---                                      ANNEX XXVIII
           RISK MITIGATION TREATMENTS FOR EGG PRODUCTS
   1. TREATMENTS OF EGG PRODUCTS FOR THE INACTIVATION OF HIGHLY PATHOGENIC
      AVIAN INFLUENZA
      The following treatments are suitable for the inactivation of highly pathogenic avian
      influenza in the following egg products:
        Egg product                                          Treatment
                                      Core temperature                   Duration of treatment
                                   (in degrees Celsius (oC))         (in seconds (s) or hours (hr))
        Liquid egg white                    55,6 oC                              870 s
                                            56,7 oC                              232 s
        10% salted yolk                     62,2 oC                              138 s
        Dried egg white                      67 oC                               20 hr
                                            54,4 oC                             513 hr
        Whole eggs                           60 oC                               188 s
                                                          completely cooked
        Whole egg blends                     60 oC                               188 s
                                            61,1 oC                               94 s
                                                          completely cooked
   2. TREATMENTS OF EGG PRODUCTS              FOR THE INACTIVATION OF INFECTION WITH
      NEWCASTLE DISEASE VIRUS
      The following treatments are suitable for the inactivation of infection with Newcastle
      disease virus in the following egg products:
        Egg product                                          Treatment
                                      Core temperature                   Duration of treatment
                                                        o
                                   (in degrees Celsius ( C))         (in seconds (s) or hours (hr))
        Liquid egg white                     55 oC                              2 278 s
                                             57 oC                               986 s
                                             59 oC                               301 s
        10% salted yolk                      55 oC                               176 s
        Dried egg white                      57 oC                              50,4 hr
EN                                            63                                                    EN
 ---pagebreak---    Whole eggs 55 oC                   2 521 s
              57 oC                   1 596 s
              59 oC                    674 s
                    completely cooked
EN             64                             EN
 ---pagebreak---                                                                   ANNEX XXIX
           LIST OF SPECIES SUSCEPTIBLE TO DISEASES FOR WHICH MEMBER STATES HAVE NATIONAL MEASURES IN
                                      ACCORDANCE WITH ARTICLE 226 OF REGULATION (EU) 2016/429
                    Disease                                                          Susceptible species
  Spring viraemia of carp (SVC)             Bighead carp (Aristichthys nobilis), goldfish (Carassius auratus), crucian carp (Carassius
                                            carassius), grass carp (Ctenopharyngodon idellus), common carp and koi carp (Cyprinus carpio),
                                            silver carp (Hypophthalmichthys molitrix), sheatfish (Silurus glanis), tench (Tinca tinca), Orfe
                                            (Leuciscus idus)
  Bacterial kidney disease (BKD)            Family: Salmonidae
  Infectious pancreatic necrosis (IPN)      Brook trout (Salvelinus fontinalis), brown trout (Salmo trutta), Atlantic salmon (Salmo salar),
                                            (Oncorhynchus spp.) whitefish (Coregonus lavaretus)
  Infection with salmonid alphavirus (SAV)  Atlantic salmon (Salmo salar), rainbow trout (Oncorhynchus mykiss), brown trout (Salmo trutta)
  Infection with Gyrodactylus salaris (GS)  Atlantic salmon (Salmo salar), rainbow trout (Oncorhynchus mykiss), Arctic char (Salvelinus
                                            alpinus), North American brook trout (Salvelinus fontinalis), grayling (Thymallus thymallus),
                                            North American lake trout (Salvelinus namaycush), brown trout (Salmo trutta)
                                            Any species which have been in contact with a susceptible species are also regarded as susceptible
  Ostreid herpesvirus 1 µvar (OsHV-1 µVar)  Pacific oyster (Crassostrea gigas)
EN                                                                      65                                                                     EN
 ---pagebreak---                                                                   ANNEX XXX
           CONDITIONS UNDER WHICH SPECIES LISTED IN COLUMN 4 OF THE TABLE IN THE ANNEX TO COMMISSION
                             IMPLEMENTING REGULATION (EU) 2018/1882 ARE REGARDED AS VECTORS
                                               Conditions under which the species of aquatic animals listed in column 4 of the table in the Annex
     List of diseases          Vectors
                                                       to Commission Implementing Regulation (EU) 2018/1882 are regarded as vectors
  Epizootic
  haematopoietic                              Regarded as vectors of Epizootic haematopoietic necrosis under all conditions.
  necrosis
  Viral haemorrhagic                          Regarded as vectors of Viral haemorrhagic septicaemia when in contact with species listed in
  septicaemia                                 column 3 of the table in the Annex to Commission Implementing Regulation (EU) 2018/1882
                                              through co-habitation or through water supply.
  Infectious                                  Regarded as vectors of Infectious haematopoietic necrosis when in contact with species listed in
  haematopoietic                              column 3 of the table in the Annex to Commission Implementing Regulation (EU) 2018/1882
  necrosis                                    through co-habitation or through water supply.
                        As listed in column 4
  Infection with highly of the table in the
  polymorphic region    Annex              to No vector species listed for infection with highly polymorphic region (HPR) deleted infectious
  (HPR) deleted         Commission            salmon anaemia virus.
  infectious salmon     Implementing
  anaemia virus         Regulation       (EU)
  Infection with        2018/1882
  Mikrocytos mackini                          No vector species listed for infection with Mikrocytos mackini.
  Infection with                              Regarded as vectors of Perkinsus marinus when in contact with species listed in column 3 of the
  Perkinsus marinus                           table in the Annex to Commission Implementing Regulation (EU) 2018/1882 through co-
                                              habitation or through water supply.
  Infection with                              Regarded as vectors of Bonamia ostreae when in contact with species listed in column 3 of the
  Bonamia ostreae                             table in the Annex to Commission Implementing Regulation (EU) 2018/1882 through co-
                                              habitation or through water supply.
EN                                                                       66                                                                       EN
 ---pagebreak---                                  Conditions under which the species of aquatic animals listed in column 4 of the table in the Annex
     List of diseases   Vectors
                                         to Commission Implementing Regulation (EU) 2018/1882 are regarded as vectors
  Infection with                Regarded as vectors of Bonamia exitiosa when in contact with species listed in column 3 of the
  Bonamia exitiosa              table in the Annex to Commission Implementing Regulation (EU) 2018/1882 through co-
                                habitation or through water supply.
  Infection with                Regarded as vectors of Marteilia refringens when in contact with species listed in column 3 of the
  Marteilia refringens          table in the Annex to Commission Implementing Regulation (EU) 2018/1882 through co-
                                habitation or through water supply.
  Infection with Taura          Regarded as vectors of Taura syndrome virus when in contact with species listed in column 3 of
  syndrome virus                the table in the Annex to Commission Implementing Regulation (EU) 2018/1882 through co-
                                habitation or through water supply.
  Infection with yellow         Regarded as vectors of yellow head virus when in contact with species listed in column 3 of the
  head virus                    table in the Annex to Commission Implementing Regulation (EU) 2018/1882 through co-
                                habitation or through water supply.
  Infection with white          Regarded as vectors of white spot syndrome virus when in contact with species listed in column 3
  spot syndrome virus           of the table in the Annex to Commission Implementing Regulation (EU) 2018/1882 through co-
                                habitation or through water supply.
EN                                                        67                                                                        EN