CELEX: 
Language: en
Date: 2019-06-14
Title: COMMISSION DELEGATED REGULATION (EU) …/... supplementing Regulation (EU) 2016/429 of the European Parliament and of Council as regards rules for the entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin

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 Law')
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                lays down rules on transmissible animal diseases and, in particular, Chapter 1 of Part V thereof lays down the animal health requirements for the entry into the Union, and the movement and handling after the 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 the rules laid down in that Regulation.
            
            
               Thus, in the interest of coherency, 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 are largely replicating rules currently laid down in existing Union acts setting out the animal health requirements for the entry into the Union, and movement and handling after the entry of consignments of animals, germinal products and products of animal origin from third countries and territories, as they have proven effective in preventing the spread of listed diseases into and within the Union.
            
            
               However, this Regulation adopts a general and unique approach for laying down animal health requirements for the entry into the Union of those consignments, as it takes account of newly available scientific knowledge and the experience gained in the application of the 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 the entry into the Union of these consignments. 
            
            
               Accordingly, this Regulation lays down the rules for entry into the Union, and movement and handling after the entry into the Union from third countries and territories of consignments 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 wild game birds;
            
            
               (d)meat products obtained from fresh meat of ungulates, poultry and wild 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; 
            
            
               (i)general rules and derogations for transit through the Union and the re-entry into the Union of consignments of animals, germinal products and products of animal origin;
            
            
               (j)transitional measures to protect the acquired rights and legitimate expectations of stakeholders resulting from pre-existing Union acts.
            
            
               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. There were no comments received from the European Parliament and the Council. A number of meetings have been held with a range of stakeholders within the framework of Animal Health Advisory Committee where the main elements of the draft act were illustrated and discussed.
            
            
               The main elements of the draft act were presented in the WTO-SPS Committee meeting in 21 March 2019 before sending the draft Regulation for notification to that Committee by July 2019. WTO Member countries will have a period of time of 2 months 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 [xx month] 2019 and [xx month] 2019 [to be supplemented later on].
            
            
               3.LEGAL ELEMENTS OF THE DELEGATED ACT
            
            
               This Delegated Regulation is to be adopted within the framework of Regulation (EU) 2016/429, and in particular pursuant to Articles 234, 237 and 239 thereof.
            
            
               COMMISSION DELEGATED REGULATION (EU) …/...
            
            
               of XXX
            
            
               supplementing Regulation (EU) 2016/429 of the European Parliament and of Council as regards rules for the 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”)
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               , 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 Regulation (EU) 2016/429. That Regulation, which came into force on 20 April 2016, and applies from 21 April 2021, repealed and replaced around 50 basic acts. It also requires the adoption of many Commission Delegated and Implementing Regulations, in order to repeal and replace around 400 Commission acts that existed in the area of animal health law before the new legal framework established by Regulation (EU) 2016/429.
            
            
               (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 Regulation (EU) No 2016/429, and 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 in the Union that could jeopardise the Union health status as regards animal diseases, and could have a detrimental economic impact on the sectors involved. 
            
            
               (4)Article 234 of Regulation (EU) 2016/429 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 an evaluation of the risks involved, apply national rules, provided that those rules comply with certain requirements laid down in that Regulation. 
            
            
               (5)The existing animal health rules, laid down in previous Commission acts concerning the control of animals, germinal products and products of animal origin entering the Union 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, the new animal health framework laid down in Regulation (EU) No 2016/429, as well as newly available scientific knowledge, international standards and the experience in the application of previous Union acts. 
            
            
               (6)The animal health requirements for the 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, in order to avoid unnecessary trade disruptions.
            
            
               (7)Regulation (EU) 2016/429 lays down rules for the prevention and control of animal diseases which are transmissible to animals or to humans. In particular, Chapter 1 of Part V thereof, which lays down the animal health requirements for the 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 that Regulation. 
            
         
         
            
               (8)Article 229(1) of Regulation (EU) 2016/429 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, as regards 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, and the animal health certificate, declarations or other document that should accompany such consignments.
            
            
               (9)In addition, Article 234(1) of Regulation (EU) 2016/429 stipulates that the animal health requirements for 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 or zones thereof must be at least as stringent as those laid down in that Regulation, and in delegated acts adopted within the framework of that Regulation, applicable to the movements within the Union of those species and categories of those commodities, or must offer equivalent guarantees to the animal health requirements provided for in Part IV of that Regulation.
            
            
               (10)Article 234(2) of Regulation (EU) No 2016/429 provides for delegated acts to be adopted in order to supplement the rules laid down in that Regulation, as regards the animal health requirements for the 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 Regulation (EU) No 2016/429 provides that Member State 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 . Furthermore, Article 237(2) thereof stipulates that the animal health certificate must have been verified and signed by an official veterinarian in the third country or territory of origin. In this context, Article 237(4) of Regulation (EU) No 2016/429 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 those consignments of those to be accompanied by declarations or other documents.
            
            
               (12)Article 239(2) of Regulation (EU) No 2016/429 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 animals, germinal products and products of animal origin, and for derogations from the general animal health requirements laid down in Articles 229(1) and 237(1) of that Regulation, and 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 this Regulation pursuant to Articles 234(2) and 239(2) of Regulation (EU) 2016/429 are interrelated, Article 234(2) lays down the general requirements for the entry into the Union of consignments of animals, germinal products and products of animal origin, while Article 239(2) thereof lays 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 Regulation (EU) 2016/429 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)Regulation (EU) 2016/429 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) 853/2004
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               . However, for the purpose of laying down the animal health requirements for the 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’, ‘processed stomachs’, ‘bladders’, ‘intestines’, ‘rendered fats’, ‘meat extracts’ and ‘blood products’ laid down in Regulation (EC) 853/2004, as, from an animal health point of view, all of those commodities represent the same animal health risk and they should be subjected to the same risk mitigating measures.
            
            
               (18)The definition of ‘carcass’ laid down in Regulation (EC) 853/2004 should be adapted to define ‘carcass of ungulate’ in order to differentiate it from 'offal' as 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 be in line with the definition included in the glossary of the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE). This definition should clarify which products of animal origin must be considered as casings and therefore should undergo the specific risk mitigating treatments provided for in this Regulation.
            
            
               (20)Article 229(1) of Regulation (EU) 2016/429 provides that the entry into the Union of consignments of animals, germinal products and products of animal origin is only to be permitted if they come from third countries or territories listed for the 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 they comply with the specific animal health requirements as regards listed diseases. This Regulation should lay down the responsibility for the competent authority to verify that such consignments entering the Union comply with those general requirements.
            
            
               (21)Article 237(1) of Regulation (EU) No 2016/429 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 lay down the responsibility for 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 Regulation (EU) 2016/429 and the relevant requirements laid down in this Regulation. This Regulation should, therefore, lay down the obligations for operators responsible for the 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 period of validity of those certificates only in the case of animals and germinal products, as they pose a higher animal health risk than products of animal origin which may have undergone risk mitigating measures. However, as the transport by sea of live animals and of germinal products may take longer than 10 days, 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 the entry into the Union of consignments of animals, germinal products and products of animal origin are related to the diseases listed in Article 5 and in Annex II to Regulation (EU) 2016/429 and their categorisation into categories A, B, C, D and E, as provided for in Article 9(1) of that Regulation and in the Annex to Commission Implementing Regulation (EU) 2018/1882
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               . 
            
            
               (25)Chapter 1 of Part II of Regulation (EU) 2016/429 provides for the rules on disease notification and reporting to ensure an early detection and an effective disease control in the Union. This Regulation should provide for 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, live animals can transmit the diseases for which they are a listed species in Regulation (EU) 2018/1882, however, not all the 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 the 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, starting with the requirements for the third country or territory of origin or zone thereof, or also the compartment thereof in the case of aquaculture animals, the establishment of origin of the animals, and the animals and the establishment of origin of the products of animal origin or the centres 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 regarding traceability and animal health visits in the establishments of origin of the animals, germinal products and products of animal origin equivalent to those laid down in Regulation (EU) 2016/429, and in delegated and implementing acts adopted within the framework of that Regulation. 
            
         
         
            
               (28)Furthermore, where a certain type of establishments keeping animals or germinal products in a third country or territory pose a particular animal health risk, it should be subject to specific approval by the competent authority in the third country or territory, 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 the entry into the Union should not be considered as representing an animal health risk in their country or territory of origin and they should not be subject to national eradication programmes or any other national restrictions based on animal health concerns. 
            
            
               (30)The animal health requirements for the 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 animal health of animals within the Union. 
            
            
               (31)The disease freedom of the third country or territory or zone and in the case of aquaculture animals, the compartment of origin must be assessed by the Union 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 those provided for in Part II of Regulation (EU) 2016/429 and Commission Delegated Regulation (EU) 2019/…[C(2019)4057]
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               . Specific conditions for certain diseases and circumstances may be required as additional risk mitigating measures. 
            
            
               (32)The disease freedom 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)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 or territory of origin or zone thereof, this Regulation should provide for a minimum residency period for the animals in the third country or territory of origin or zone thereof, as well as in the 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. Moreover, horses intended for competitions, races and cultural events, because of their high level health status, should be exempted from a minimum residency period when those horses comply with additional guarantees. 
            
            
               (35)The health status of the animals, germinal products and products of animal origin intended for entry into the Union may be jeopardised during their 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 or territories with a lower health status than the country or territory of origin, therefore certain preventive measures should be applied in order to preserve their health status. 
            
            
               (36)Terrestrial animals, hatching eggs and aquatic animals intended for entry into the Union should only be transported through or unloaded in third countries or territories which are also listed for the entry into the Union of the same species and categories of animals and hatching eggs which therefore provide equivalent animal health guarantees as the third country or territory of origin. 
            
            
               (37)However, the transport of terrestrial animals and hatching eggs by means of aircraft or vessel could be subject to unforeseen events such as mechanical problems of 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, in order to allow the continuation of the transport of the terrestrial animals and hatching eggs to the Union, while at the same time ensuring the health status of those commodities and preventing additional animal health risks.
            
            
               (38)Assembly operations of animals in third countries or territories of origin may pose an additional risk to the animal health status of the animals intended for entry into the Union, as a result of coming mixing and getting into contact with animals of different origins. Therefore, the number, the duration of those operations and the species allowed to undergo such operations should be limited to the minimum and for those species with reliable traceability systems. 
            
            
               (39)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. 
            
            
               (40)Different species of ungulates, as defined in Regulation (EU) 2016/429, are listed as susceptible species for different listed diseases in Commission Implementing Regulation (EU) 2018/1882. Furthermore, listed diseases are 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.
            
            
               (41)In order to prevent the occurrence of 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 disease freedom. For those diseases for which the Union has a compulsory eradication programme, this Regulation should provide for risk mitigating measures where the third country or territory of origin is not completely free of such diseases.
            
            
               (42)Where consignments of ungulates are intended for the entry into Member States which are officially disease-free, or which have an approved programme for 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 those animals do not jeopardise the health status of those specific Member States as regards those diseases.
            
            
               (43)Special rules as regards the third country, territory or zone 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, taking 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, territory or zone of origin.
            
            
               (44)The confined establishment of origin could be located in a third country or territory which is not listed for the entry into the Union of the specific species of ungulates. However, the national legislation and the veterinary services of the third country or territory should have been assessed and listed for the entry into the Union of other commodities falling within the scope of this Regulation. In addition, the establishment of origin should comply with additional requirements as regards disease surveillance, veterinary supervision, record keeping and operations. In order to ensure that those guarantees can be provided, specific conditions for the approval of those confined establishments by the competent authority in the third country or territory should be laid down in this Regulation. A list of such confined establishments should be established by the Member State of destination, following a favourable assessment by the competent authority of that Member State of all relevant information provided by the establishment as regards the animal health risks involved.
            
            
               (45)Specific animal health requirements should apply for the entry into the Union of poultry and other 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 other captive birds, and provide effective protection against the spread into the Union of diseases of concern from third countries or territories. 
            
            
               (46)In order 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.
            
            
               (47)Taking into account the activities and the 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 countries, territories or zones of origin of the captive birds, and the captive birds should be quarantined upon their arrival in the Union in order to confirm the absence of any disease of concern. 
            
         
         
            
               (48)In addition, where consignments of birds and hatching eggs are intended for Member States with disease-free status from infection with Newcastle disease virus without vaccination, additional requirements should be complied with in order to ensure that those consignments do not jeopardise the health status for that disease of those specific Member States.
            
            
               (49)The small hive beetle (Aethina tumida) is one of the diseases of most concern for the bees. It is largely exotic to the Union but has spread globally in the last decades, thereby creating serious problems for the apiculture industry potentially affecting also bumbe bees. The Tropilaelaps mites (Tropilaelaps spp.) are potentially devastating pathogens of honeybees, exotic to the Union. Effective and 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 the agriculture and the environment which benefits from pollination services by kept and wild bees. 
            
            
               (50)In addition, American foulbrood occasionally occurs in the Union but is controlled for 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 and therefore such rules should be laid down in this Regulation.
            
            
               (51)Only queen bees without brood and accompanied by a small number of attendants in single queen bee 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.
            
            
               (52)Colonies of bumble bees bred and reared in environmentally isolated establishments are often traded for the horticultural industry. In view of 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 bred, reared and packaged solely under environmentally controlled conditions in establishments and which can be checked to be free of the small hive beetle.
            
            
               (53)Because its potential effects on humans and animals, rabies is the listed disease of most concern in the Union affecting dogs, cats and ferrets and therefore Member States are required to carry out a compulsory eradication programme against infection with that disease in accordance with Regulation (EU) 2019/… as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases [document C(2019)4056]. Taking into account the availability and effectiveness of the existing vaccines against this disease, vaccination should be required for all consignments of dogs, cats and ferrets entering the Union to prevent any possibility of the introduction of rabies into the Union.
            
            
               (54)Dogs intended for the entry into a Member State with disease-free status or an approved eradication programme for Echinococcus multilocularis should comply with additional requirements in order to ensure the protection of that status in those Member States. As this regard, a preventive treatment should be applied to those dogs before entering the Union. However, special rules as regards rabies and infestation with Echinococcus multilocularis and additional animal health requirements should apply where dogs, cats and ferrets are intended for a confined establishment in the Union taking into account the specificity of their activities and the specific conditions under which animals are kept in those establishments.
            
            
               (55)Germinal products, in particular semen, but also to a lesser extent oocytes and embryos may represent an important risk for the spread of animal diseases. They are collected or produced from a limited number of donors, but are used widely in the general animal population so they can, if not handled properly or not classified with the correct health status, be a source of diseases for a large number of animals. Such cases have occurred in the past and have caused substantial economic losses. Therefore, the animal health requirements for entry into the Union of germinal products of certain kept terrestrial animals shall be established.
            
            
               (56)The requirements for the entry into the Union of germinal products of ungulates should primarily consider the requirements for entry into the Union of live animals. 
            
            
               (57)Specific requirements for the germinal product establishments where germinal products of ungulates, eligible for entry into the Union, are collected, produced, processed and stored and the traceability and animal health requirements for germinal products should reflect those established for the movements within the Union. 
            
            
               (58)Due to the need to move germinal products from confined establishments located in third countries to confined establishments located in the Union, special traceability and animal health requirements for such entry into the Union should be laid down in this Regulation.
            
            
               (59)Animal health requirements for the entry into the Union of hatching eggs should address the risks posed for the introduction into the Union of listed diseases by the different categories of hatching eggs, therefore they should relate to those for the entry into the Union of the respective species or categories of birds.
            
            
               (60)Where hatching eggs of poultry are intended for the entry into Member States with status-free from infection with Newcastle disease virus without vaccination, they should comply with additional requirements to ensure that those eggs do not jeopardise the status of those specific Member States.
            
            
               (61)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 should be effective to mitigate the risk they pose depending on the species of origin of the product and the country or territory of origin. 
            
            
               (62)The risks linked to fresh meat entering the Union should be mitigated by way of requirements as regards the disease freedom of the third country or territory of origin and requirements regarding animal diseases for the live animals from which the meat is obtained, the dispatch of the kept animals to slaughter, the slaughter and killing operations, the handling and preparation operations. 
            
            
               (63)Fresh meat of terrestrial animals can be obtained from kept animals, including farmed game as defined in Regulation (EC) No 853/2004, and wild animals. However, in the Union some species are traditionally kept as production animals, in controlled environments, whereby specific health statuses for those species have been achieved. This applies, in particular, to terrestrial animals belonging to the species Bos taurus, Capra hirchus and Ovis aries. In order to safeguard their health status and provide adequate guarantees for these production species in the Union, it is appropriate to exclude those species from the possibility to be categorised as farmed game or wild animals, when the fresh meat intended to entry into the Union originate from those species. 
            
            
               (64)When an outbreak of a relevant animal health 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 establish the possible animal health risks associated with those animals and the products of animal origin thereof. 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 to entry fresh meat into the Union to the Union. 
            
            
               (65)The type of treatment to be applied to products of animal origin should be in line with the risk posed by the third country, territory or zone thereof manufacturing the meat product. Non-specific treatments should be assigned only to third countries or territories or zones thereof that provide all the guarantees as regards freedom of the relevant diseases. In the case of 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 when those products are subject to a specific treatment.
            
            
               (66)When the third country or territory or zone thereof is sourcing 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 order to mitigate all possible animal health risks the meat product shall always be subjected to the most severe specific treatment. 
            
            
               (67)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 shall be subjected to a treatment effective to mitigate the risk in the third country or territory or zone thereof listed for entry into the Union, to allow continuation of trade 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.
            
         
         
            
               (68)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. 
            
            
               (69)The treatments to mitigate the 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 EFSA Panel on Animal Health and Welfare
                  6
               .
            
            
               (70)Fresh meat and products of animal origin from equine animals do not pose an animal health risk in relation to listed diseases and therefore animal health requirements for fresh meat and products of animal origin from equine animals intended for entry into the Union should not be laid down in this Regulation.
            
            
               (71)The conditions for entry into the Union of raw milk, dairy products, colostrum and colostrum products are based on the animal health risks that the species of origin may pose, which are mainly related to foot and mouth disease and can be mitigated with the application of specific treatment. Therefore, dairy products of animal species other than Bos taurus, Ovis aries, Capra hircus, Bubalus bubalis and Camelus dromedaries should undergo the most severe risk mitigating treatment.
            
            
               (72)Treatments for products of animal origin should be carried out always in the third country or territory of origin or zone thereof listed for the entry of those products into the Union. The type of treatment to be applied to the products of animal origin should be in line with the animal health risk and therefore in line with the risk posed by the third country or territory of origin. 
            
            
               (73)Aquatic animals of listed species are sometimes transported by sea in vessels which may exchange water during the voyage. In such cases, in addition to a health certificate, the animals should also be accompanied by a declaration which is signed by the Master of the vessel and which outlines details of the ports of origin and destination as well as 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. 
            
            
               (74)Aquatic animals may enter the Union for many different purposes. Given the disease risk associated with the movement of live animals, such animals which enter 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 listed diseases represent a lower risk, and the measures to be taken in relation to these products which enter the Union for further processing, are therefore, less rigorous than those which apply to live animals. 
            
            
               (75)Releasing aquatic animals into the wild in natural waters is a high-risk activity if those animals are infected with a listed disease. Specifically in the case of category A and B diseases, the third country or territory of origin or zone or compartment thereof should be free of those diseases. In addition, aquatic animals which have entered the Union with the purpose of being released into the wild in natural waters should, in all cases, even when the Member State of destination or zone or compartment thereof is not free from a specific category C disease, originate from a third country or territory or zone or compartment thereof which has been declared free of that category C disease.
            
            
               (76)Member States may take national measures under Article 226 of Regulation (EU) 2016/429 which are designed to limit the impact of diseases other than listed diseases within their own territory. In such cases, consignments of species which are susceptible to the diseases to which those national measures apply shall also originate from third countries, territories, zones or compartments thereof, which are free of those diseases. 
            
            
               (77)Article 226 of Regulation (EU) 2016/429 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 appropriate therefore, to continue to recognise the list of Member States that have taken national measures under Directive 2006/88/EC and the list of diseases for which they have obtained those measures. These details are set out in Annex 29 of this Regulation. 
            
            
               (78)The requirement for aquatic animals of listed species and products of animal origin from those animals to originate from a disease- free third country or territory or zone or compartment thereof is not mandatory in all situations. Certain risk mitigation measures can be taken which facilitate the entry into the Union of aquatic animals and certain products of animal origin thereof which do not originate from a disease- free third country or territory or zone or compartment thereof. Certain risk mitigation measures are acceptable for aquatic animals of listed species and different mitigation measures are acceptable for products of animal origin from those species.
            
            
               (79)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 crustacea 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 the way they have been treated or packaged before dispatch or because they are not intended for storage in the Union, prior to processing.
            
            
               (80)Certain products of animal origin of listed species may also be derogated from the requirement to originate in a third country or territory or zone or compartment thereof which is free of relevant listed diseases. The risk mitigation measures which allow such trade to occur relate to the fact that the animals are consigned to a disease control aquatic food establishment in the Union for further processing, or to the fact that the products of animal origin consist of fish which were slaughtered and eviscerated prior to dispatch to the Union. In either case, the risk posed by the products of animal origin is assessed to be acceptable.
            
            
               (81)Commission Implementing Regulation (EU) 2018/1882 establishes a list of species and groups of species that pose a considerable risk for the spread of the diseases which are listed in Article 5 and Annex II to Regulation (EU) 2016/429. This list also includes a list of vector species. Many of these species do not however, act as vectors in all circumstances. Details of the circumstances in which these species are vectors of the listed diseases are set out in Annex 30 of this Regulation. In circumstances where aquatic animals of listed species do not fulfil the conditions to be vectors, they are not covered by the provisions of this Regulation.
            
            
               (82)All of the derogations and handling requirements which are set out in Part V of this Regulation in relation to aquatic animals of listed species and products of animal origin from those listed species, also apply to the diseases for which Member States have taken national measures under Article 226 of Regulation (EU) 2016/429 and to the relevant susceptible species set out in Annex 29.
            
            
               (83)It is important that aquatic animals of listed species, products of animal origin from those species, and water in which they are transported, are handled appropriately after entry into the Union. The objective is to ensure that they do not represent a disease risk after entry. Appropriate handling includes ensuring that the animals and products of animal origin 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. 
            
            
               (84)In certain cases and for reasons which are justifiable, the competent authority at the place of destination may however, allow authorisation for such animals to be released into natural waters. In all such cases, the competent authority ensures that the release or immersion does not jeopardise the health status at the place of release. Further than that, even if the receiving waters are not free of a specific Category C disease, the animals to be released should be free of that disease, in order to ensure the best overall health status is achieved for wild populations in natural waters of the Union.
            
            
               (85)Derogations and special rules for transit are established under specific conditions linked to the place of origin to cover situations where the Union is not the final destination for the animals and products thereof and to take into account geographical constrains and geopolitical factors. 
            
            
               (86)Derogations and special rules are also established to allow for the transit of consignments of animals and products thereof via a third country or territory between Member States to cover situations where such type of entry into the Union is required by a Member State.
            
            
               (87)Special rules under Article 239 of Regulation (EU) 2016/429 are laid down to allow the return of certain commodities that have been refused by the competent authorities of a border control post of a third country or territory taking into account that those commodities have been produced under the Union’s animal health legislation.
            
         
         
            
               (88)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 cultural events.
            
            
               (89)This Delegated Regulation should be applicable from 21 April 2021 in accordance with the date of application provided for in Regulation (EU) 2016/429,
            
            
               HAS ADOPTED THIS REGULATION:
            
            
               PART I
                  General rules
            
            
               Title 1
                  Subject matter, scope and definitions
            
            
               Article 1
                  Subject matter and scope
            
            
               1.This Regulation lays down the 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, territories, 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 falling with the scope of this Regulation (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 (Article 5); 
            
            
               (c)the general animal health requirements for the 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 (Articles 6 to 10).
            
            
               3.Part II lays down the general animal health requirements for the entry into the Union, as well as the movement and handling after the entry, and derogations from such requirements for terrestrial animals (Title 1).
            
            
               In addition, it lays down specific animal health requirements that are also applicable to the following species and categories of terrestrial animals:
            
            
               (a)ungulates (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 the 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).
            
            
               5.Part IV lays down the general animal health requirements for the entry into the Union, as well as the movement and handling after the entry, and derogations from those requirements for products of animal origin of the following species and categories of terrestrial animals:
            
            
               (a)kept and wild ungulates; 
            
            
               (b)poultry; 
            
            
               (c)wild game birds.
            
            
               6.Part V lays down the animal health requirements for the entry into the Union, as well as the movement and handling after the entry, and derogations from those requirements for the following species of aquatic animals at all life stages as well as their products of animal origin, 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 29 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 the transitional and final provisions.
            
            
               Article 2
                  Definitions
            
            
               For the purposes of this Regulation, the definitions laid down in 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 from which the entry into the Union of specific species and categories of animals, germinal products and products of animal origin is permitted in accordance with implementing acts adopted accordance with Article 230(1) of Regulation (EU) 2016/429;
            
            
               (2)‘the list’ means the list of third countries, territories or zones thereof authorised for the 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 in accordance with Article 230(1) of Regulation (EU) 2016/429;
            
            
               (3)‘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 mitigating measures and health guarantees when equine animals enter into the Union. 
            
            
               (4)'means of transport' means road or rail vehicle, vessels and aircrafts;
            
            
               (5)‘container’ means any crate, box, receptacle or other rigid structure used for the transport of animals or eggs which is not the means of transport;
            
         
         
            
               (6)'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;
            
            
               (7)'ovine animal' means an animal of the species of ungulates belonging to the genus Ovis and the offspring of crossings of those species;
            
            
               (8)'caprine animal' means an animal of the species of ungulates belonging to the genus Capra and the offspring of crossings of those species;
            
            
               (9)'porcine animal' means an animal of the species of ungulates belonging to the family Suidae;
            
            
               (10)'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;
            
            
               (11)'camelid animal' means an animal of the species of ungulates belonging to the family Camelidae;
            
            
               (12)'cervid animal' means an animal of the species of ungulates belonging to the family Cervidae;
            
            
               (13)'honeybee' means an animals of the Apis mellifera species;
            
            
               (14)'bumble bee' means an animal of the species belonging to the genus Bombus;
            
            
               (15)'dog' means a kept animal of the Canis lupus species;
            
            
               (16)'cat' means a kept animal of the Felis silvestris species;
            
            
               (17)'ferret' means a kept animal of the Mustela putorius furo species;
            
            
               (18)'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 includes all birds sharing the same airspace.
            
            
               (19)‘animals intended for slaughter’ means kept terrestrial animals to be transported, either directly or after undergoing an assembly operation, to a slaughterhouse;
            
            
               (20)'breeding poultry' means poultry 72 hours old or more, intended for the production of hatching eggs;
            
            
               (21)‘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;
            
            
               (22)'day-old chicks' means poultry less than 72 hours old;
            
            
               (23)‘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;
            
            
               (24)‘racing pigeon’ means any pigeon transported or intended for transport from its pigeon house to another Member State in order to be released to fly back to the Member State of origin;
            
            
               (25)'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’);
            
            
               (26)‘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;
            
            
               (27)‘semen’ means the ejaculate of an animal or animals, either in the unaltered state or prepared or diluted;
            
            
               (28)‘oocytes’ means the haploid stages of the ootidogenesis including secondary oocytes and ova;
            
            
               (29)‘embryo’ means the initial stage of development of an animal while it is capable of being transferred to a recipient dam;
            
            
               (30)‘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; 
            
            
               (31)'unique approval number' means a number assigned by the competent authority;
            
            
               (32)‘centre veterinarian’ means the veterinarian responsible for the activities carried out at the semen collection centre, at the germinal product processing establishment or at the germinal product storage centre as provided for in this Regulation;
            
            
               (33)‘team veterinarian’ means the veterinarian responsible for the activities carried out by an embryo collection team or by an embryo production team as provided for in this Regulation; 
            
            
               (34)‘quarantine accommodation’ means a facility authorised by the competent authority for the purpose of the isolation of bovine, porcine, ovine or caprine animals for a period of at least 28 days before they are admitted to a semen collection centre;
            
            
               (35)‘semen collection centre’ means a germinal product establishment approved by the competent authority for the collection, processing, storage and transport of semen of bovine, porcine, ovine, caprine or equine animals intended for entry into the Union;
            
            
               (36)‘embryo collection team’ means a germinal product establishment comprised of a group of professionals or structure approved by the competent authority for the collection, processing, storage and transport of in vivo derived embryos intended for entry into the Union;
            
            
               (37)‘embryo production team’ means a germinal product establishment comprised of a group of professionals or structure approved by the competent authority for the collection, processing, storage and transport of oocytes, and the in vitro production, where applicable with stored semen, processing, storage and transport of embryos, both intended for entry into the Union;
            
            
               (38)‘germinal product processing establishment’ means a germinal product establishment approved by the competent authority for the processing, including semen sex-sorting where appropriate, and the storage of semen, oocytes or embryos of one or more species, or any combination of those types of germinal products or species, intended for entry into the Union; 
            
            
               (39)‘germinal product storage center’ 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 wild game birds which are suitable for human consumption; 
            
            
               (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)'carcass 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 carcass of an ungulate even if it remains naturally connected to the carcass;
            
            
               (44)'meat products' means processed products, including stomachs, bladders, intestines, rendered fats, meat extracts and blood products, 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 three to five 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 136 of Regulation (EU) No 2017/625.
            
            
               Title 2
                  General animal health requirements for the entry into the Union, and movement and handling after the entry of consignments of animals, germinal products and products of animal origin
            
            
               Article 3
                  Obligations of the competent authorities of Member States
            
            
               1.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 falling within the scope of this Regulation, 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, germinal products and products of animal origin, and in the case of aquaculture animals, a compartment 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 the 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 germinal products, the animal health certificate, referred to in point (c)(i) must have been issued within the period of 10 days before the date of arrival of the consignment at the border control post; however, in the case of transport by sea that period may be extended by an additional period corresponding to the duration of the journey by sea.
            
            
               Article 4
                  The date of certification of consignments 
            
            
               1.Consignments of animals, germinal products and products of animal origin of species and categories falling within the scope of this Regulation shall only be permitted to enter the Union provided that such consignments were certified for dispatch to the Union not earlier than the date on which the third country or territory of origin or zone thereof, or compartment thereof in the case of aquaculture animals, was listed for the entry into the Union of the particular species and category of animals, germinal products and products of animal origin. 
            
            
               2.Consignments of animals and hatching eggs 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 the entry into the Union of the specific species and category of animals and hatching eggs. 
            
            
               Article 5
                  Obligations of operators
            
            
               1.Operators responsible for the 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) 2017/425, and shall ensure that such consignments comply with the following requirements: 
            
            
               (a)the general animal health requirements for the 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 species and categories falling within in the scope of this Regulation from the point of arrival 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)comply with the requirements of Article 3, so that the competent authority may permit the entry of the consignments into the Union; 
            
            
               (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 the 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 or case of a listed disease referred to in Annex 1, which are relevant for the listed species in the consignment or for the listed species of origin of the germinal products or products of animal origin 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, identify, control and eradicate 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 1 for:
            
            
               (i)the animals intended for entry into the Union; or
            
         
         
            
               (ii)the animals of origin of the germinal products or the products of animal origin intended for entry into the Union.
            
            
               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:
            
            
               (a)are not animals to be killed under a national programme 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 clinical signs 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 for dispatch to the Union, was not subject to national restriction measures:
            
            
               (i)for animal health reasons; or 
            
            
               (ii)due to the occurrence of increased mortality, including cases of listed diseases referred to in Annex 1 and emerging diseases. 
            
            
               2.Consignments of germinal products shall only be permitted to enter the Union if they were obtained from donor animals which at the time of collection:
            
            
               (a)did not show clinical signs 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 1 and emerging diseases. 
            
            
               3.Consignments of products of animal origin shall only be permitted to enter the Union if they were obtained from animals which:
            
            
               (a)in the case of terrestrial animals, did not show clinical signs 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 clinical signs of transmissible diseases at the time of:
            
            
               (i)slaughter for the production of products of animal origin; or
            
            
               (ii)the collection or packing of molluscs and live crustaceans intended for human consumption.
            
            
               (c)in the case of the animals referred to in points (a) and (b), 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 1 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 animals, or the establishment of origin of the 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; 
            
            
               (b)it must be approved, where required by this Regulation, by the competent authority of the third country or territory of origin; 
            
            
               (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 three 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 1 relevant for the particular species and category of animal, germinal product or product of animal origin and emerging diseases.
            
            
               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 Regulation (EU) 2019/… as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases [document C(2019)4056];
            
         
         
            
               (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 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, as defined in Regulation (EU) 2017/425.
            
            
               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 have been demonstrated by the competent authority of the third country or territory of origin:
            
            
               (a)in accordance with Regulation (EU) 2019/… as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases [document C(2019)4056]; or
            
            
               (b)for diseases not falling within the scope of 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 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 2;
            
            
               (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 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)they shall have been specifically assigned by the Union in the list, to the third country or territory or zone thereof listed for the entry into the Union of the specific species and category of animals, germinal products and products of animal origin.
            
            
               PART II
                  Animal health requirements for the entry into the Union of kept terrestrial animals as referred to in Articles 3 and 5
            
            
               TITLE 1
               GENERAL ANIMAL HEALTH REQUIREMENTS FOR KEPT TERRESTRIAL ANIMALS 
            
            
               Article 11
                  The residency period required for kept terrestrial animals
            
            
               Consignments of kept terrestrial animals other than dogs, cats and ferrets, shall only be permitted to enter the Union subject to compliance with the following requirements:
            
         
         
            
               (a)the animals complied with the relevant residency period set out in the following tables of Annex 3 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)during the residency periods referred to in point (a), the animals:
            
            
               (i)remained continuously in the third country or territory of origin or zone thereof; 
            
            
               (ii)remained continuously in the establishment of origin, and no animals were introduced into that establishment during that period; 
            
            
               (iii)had no contact with animals of a lower health status.
            
            
               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, registered horses for competition and races shall be regarded as complying with the residency period provided for in Table 1 of Annex 3, if they have been resident during the period indicated in Table 1 of Annex 3 prior to their dispatch in:
            
            
               (a)a Member State; or 
            
            
               (b)a listed third country, territory of intermediate residency, or zone thereof, from where the entry into the Union of registered horses is authorised for that purpose and provided that they were introduced into the third country or territory of origin, or zone thereof, in accordance with animal health requirements providing animal health guarantees at least as stringent as those applicable to the direct entry into the Union of registered horses for competition and races from that third country or territory of intermediate residence, or zone thereof.
            
            
               2.By way of derogation from point (b)(ii) of Article 11, registered horses for competition, races and cultural events shall be regarded as complying with the residency period provided for in Table 1 of Annex 3 if they were resident 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 1 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 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 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 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 1 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 dogs, cats and ferrets the inspection referred to therein may be carried out within the period of 48 hours prior to the time of loading for dispatch to the Union.
            
            
               Article 14
               General rules for the dispatch to the Union of terrestrial animals
            
            
               1.Consignments of terrestrial animals shall only be permitted to enter the Union if, from the time of loading at the establishment of origin for dispatch to the Union until the time of their arrival in the Union, the terrestrial animals have not been in contact with other terrestrial animals of:
            
            
               (a)the same species, not intended for the entry into the Union;
            
            
               (b)other species listed for the same diseases, not intended for the 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 the entry into the Union of the specific species and category of animals and intended use into 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)evidence 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 except 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, except 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, territory or zone thereof for the entry of the particular species and category of animals into the Union, only if the transhipment operation took place because of the occurrence of a technical problem or another unforeseen incident causing logistic problems during the transport of the animals to the Union by sea or by air, in order to complete the transport to the point of entry into Union, provided that:
            
            
               (a)the entry into the Union of the 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 a third country or territory throughout the operation to ensure that:
            
            
               (i)effective protection measures against vectors of relevant animal diseases were provided; 
            
         
         
            
               (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, territory or zone thereof for the 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 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, territory or zone thereof for the 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 were transported to the Union by sea or by air;
            
            
               (b)they 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 were provided and the equine animals did not come into contact with equine animals of a lower health status; 
            
            
               (ii)the equine animals were transferred directly and as quick as possible to the vessel or aircraft to be used for onward travel, which must have complied with requirements laid down in Article 17, without leaving the boundaries of the port or airport under the direct supervision of an official veterinarian. 
            
            
               (d)an official veterinarian must have certified that the consignment complied with the requirements laid down in point (a), (b) and (c). 
            
            
               Article 17 
                  General requirements regarding means of transport of terrestrial animals 
            
            
               1.Operators, including transporters, shall ensure that the means of transport used for transporting consignments of kept terrestrial animals intended for entry into the Union 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, immediately before every transportation of animals or any item representing an animal health risk, and, if necessary, disinfected again and in any case dried or allowed to dry before any new loading of animals.
            
            
               2.Paragraph 1 shall not apply to the transport of consignments of honeybees and bumble bees intended for the entry into the Union. See comment at Article 19.
            
            
               Article 18
                  Requirements regarding containers in which terrestrial animals are transported to the Union
            
            
               Operators shall ensure that containers in which kept terrestrial animals are transported to the Union in the means of transport:
            
            
               (a)comply with the requirements in Article II.1.1-1(a) of 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];
            
            
               (b)contain only animals of the same species and category coming from the same establishment;
            
            
               (c)are either:
            
            
               (i)single use purpose-designed disposable containers to be destroyed after first use; or
            
            
               (ii)cleaned and disinfected after each use and dried before subsequent use.
            
            
               Article 19
                  Movement and handling after the entry of terrestrial animals
            
            
               1.Following their entry into the Union, consignments of terrestrial animals shall be transported directly without delay to:
            
            
               (a)their establishment of destination in the Union, where they shall remain at least for the period of time required in the relevant specific articles in Parts II to V; 
            
            
               (b)the slaughterhouse of destination in the Union, if they are intended for slaughter, and they must be slaughtered within a period of five 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, 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/… reference to SANTE/7146/2018.
            
            
               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 directly from the establishment of origin to the border control post of first arrival in the Union.
            
            
               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 they 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, 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 Article 5 of Regulation (EU) 2019/… as regards rules for establishments keeping terrestrial animals and hatcheries, and the traceability of certain kept terrestrial animals and hatching eggs [document SANTE 7016/2018];. 
            
            
               (ii)which has an 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 Regulation (EU) 2019/… as regards rules for establishments keeping terrestrial animals and hatcheries, and the traceability of certain kept terrestrial animals and hatching eggs [document SANTE 7016/2018];
            
            
               (iv)where the following records are kept up-to-date for a period of at least three years: 
            
            
               –the origin of the animals; 
            
            
               –the dates of arrival and dispatch to and from the assembly centre; 
            
            
               –the identification number 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.
            
            
               (v)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, which shall be taken into account when sampling for testing before dispatch to the Union 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 ungulates were individually identified before 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 conformance 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 those animals are individually identified by:
            
         
         
            
               (d)an injectable transponder or an alternative method of identification which ensures an unequivocal link between the animal and its accompanying entry documentation; 
            
            
               (e)an identification document, issued at the latest at the time of certification for entry into the Union, which describes and depicts the animal so as to link it to the certificate, and contains information on the individual code emitted by the implanted transponder or the alternative method of identification referred to in point (a). 
            
            
               3.Where ungulates are identified with an electronic identifier which does not comply with ISO Standards 11784 and 11785 the operator responsible for the 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 those animals 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 4, and for the period referred to in that table.
            
            
               2.Consignments of equine animals shall only be permitted to enter the Union if those animals 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 4, and 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 4 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 4 under the relevant specific conditions referred therein. 
            
            
               4.Consignments of ungulates shall only be permitted to enter the Union if those animals originate from a third country or territory or zone thereof where vaccination against the category A diseases referred to in Part C of Annex 4 has not been carried out in accordance with the details set out in: 
            
            
               (a)point 1 of that Annex in the case of ungulates, other than equine animals; 
            
            
               (b)point 2 of that Annex in the case of equine animals.
            
            
               5.As regards infections with Mycobacterium tuberculosis complex (M. bovis, M. caprae, M. tuberculosis), 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 without vaccination; or 
            
            
               (b)comply with the requirements set out in point 1 of Annex 5.
            
            
               6.As regards infections with Brucella abortus, B. melitensis and B.suis, consignments of bovine, ovine and caprine 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 without vaccination; or 
            
            
               (b)comply with the requirements set out in point 2 of Part A of Annex 5.
            
            
               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 those animals originate either:
            
            
               (a)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 6.
            
            
               8.As regards enzootic bovine leukosis, consignments of ungulates 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 6.
            
            
               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 7, for which the species of ungulates are listed, shall only be permitted to enter the Union if those animals: 
            
            
               (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 those animals:
            
            
               (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 8, for which the species of ungulates intended for the entry into the Union are listed, has been reported in an area and for a period set out in the tables in:
            
            
               (i)points 1 and 2 of that Annex for ungulates other than equine animals; or
            
            
               (ii)points 3 and 4 of that Annex for equine animals.
            
            
               (b)during the period referred to in point (a) 1, 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, caprine, camelid and cervid animals shall only be permitted to enter the Union if the establishment of origin of those animals complies with the relevant requirements set out in point 1 of Annex 9. 
            
            
               3.As regards infection with Brucella (B. 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 those animals complies with the relevant requirements set out in point 2 of Annex 9. 
            
            
               Article 24
               The ungulates of the consignment
            
            
               1.Consignments of ungulates shall only be permitted to enter the Union if those animals 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 4 in the case of ungulates other than equine animals; or
            
            
               (ii)point 2 of Part C of Annex 4 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 8 in the case of ungulates other than equine animals; or
            
            
               (ii)points 3 and 4 of Annex 8 in the case of equine animals.
            
            
               2.As regards infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae, M. tuberculosis) and infection with Brucella (B. abortus, B. melitensis and B.suis) consignments of listed species of ungulates shall only be permitted to enter the Union if the animals 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 have not been vaccinated with a live vaccine against infection with BTV in the last 60 days before 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 7, for which the species of ungulates are listed, shall only be permitted to enter the Union if those animals have not been vaccinated against those diseases. 
            
            
               5.In addition to requirements laid down in paragraph 1, consignments of uncastrated males of ovine animals, porcine animals and ungulates of the family Tayassuidae shall only be permitted to enter the Union if those animals comply with the relevant specific requirements as regards infection with Brucella laid down in Annex 10.
            
            
               6.In addition to requirements laid down in paragraph 1, consignments of equine animals shall only be permitted to enter the Union if those animals comply with the specific conditions set out in point 2 of Annex 11, depending on the sanitary group, as determined in accordance with point 1 of Annex 11, to which the third country or territory or zone thereof has been assigned in the list. 
            
            
               Article 25
                  Derogations and additional requirements for the 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 those animals 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 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 the entry into the Union of kept ungulates intended for confined establishments 
            
            
               Article 27
                  Derogations from certain animal health requirements for ungulates intended for confined establishments
            
            
               By way of derogation from Articles 11, 22, 23, 24 and 26, consignments of ungulates intended for confined establishments shall only be permitted to enter the Union provided that those animals:
            
            
               (a)originate from a confined establishment in a third country or territory and are intended for a confined establishment in the Union;
            
            
               (b)comply with the additional requirements set out in Articles 28 to 35.
            
            
               The derogation provided for in the first subparagraph shall not apply to equine animals except zebras.
            
            
               Article 28
                  Additional animal health requirements for ungulates intended for confined establishments
            
            
               1.Consignments of ungulates intended for confined establishments only be permitted to enter the Union if those ungulates comply with the following requirements:
            
         
         
            
               (a)they must originate 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 the entry of each consignment of ungulates, referred to in paragraph 1, after carrying out 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 the ungulates destined to a confined establishment in the Union 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 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 consignment 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 arrival in the Union of the ungulates, of the authorisations granted pursuant to paragraph 1 and 2, prior to 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, after carrying out an assessment based on the following: 
            
            
               (a)compliance by the confined establishment with the requirement to be approved by the competent authority of the third country or territory of origin laid down in Article 30; 
            
            
               (b)the competent authority of the third country or territory of origin must have provided sufficient information to guarantee that the confined establishment complies with the requirements concerning the approval of confined establishments laid down in Article 30.
            
            
               3.Member States shall keep the lists of confined establishments provided for in paragraph 1 up-to-date, taking into account in particular any suspension or withdrawal of the approval granted by the competent authority of a third country or territory of origin as referred to in Article 30, or by the competent authority of another Member State.
            
            
               4.Member States shall make the lists provided for in paragraph 1 publicly available on their websites.
            
            
               Article 30
                   Conditions for confined establishments of origin of ungulates in third countries or territories for the purpose of Article 29
            
            
               Member States shall only include a confined establishment located in a third country or territory on the list of confined establishments provided for in Article 29, if the confined establishment is approved by the competent authority of the third country or territory and complies with the following conditions: 
            
            
               (a)it must have an approval number assigned by the competent authority of the third country or territory;
            
            
               (b)it must be clearly demarcated and the acces of animals and humans to animal facilities must be controlled;
            
            
               (c)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;
            
         
         
            
               (d)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;
            
            
               (e)as regards disease surveillance and control measures:
            
            
               (i)it must implement an appropriate disease surveillance plan 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, laboratory or post-mortem testing ungulates suspected of being infected or contaminated by agents of listed diseases or emerging disease;
            
            
               (iii)it must carry out, as appropriate, the vaccination and treatment of susceptible ungulates against transmissible diseases; 
            
            
               (f)it must keep, for a minimum period of three 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 where appropriate) of ungulates arriving or leaving the confined establishment, together with information on the establishment of origin or destination of such animals, the means of transport and the health status of those animals;
            
            
               (iii)details of the implementation and results of the disease surveillance and control plan provided for in point e(i);
            
            
               (iv)the results of clinical and laboratory tests and of post-mortem examinations provided for in point e(ii); 
            
            
               (v)details of the vaccination and treatment provided for in point e(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.
            
            
               (g)it must ensure the disposal of the carcasses of ungulates which die of a disease or are euthanised; and
            
            
               (h)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 plan referred to in point e(i) at least annually.
            
            
               (i)by way of derogation of point (c) of Article 9, either have:
            
            
               (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 approved veterinarian.
            
            
               Article 31
                  Derogation from the requirement of listing of the confined establishment of origin of ungulates 
            
            
               1.By way of derogation from the requirements laid down Article 3 and Article 28(1)(a), 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 arrival in the Union of the ungulates, of the authorisations granted pursuant to paragraph 1 and 2, prior to possible movement through other Member States and prior to the arrival of such ungulates into their territory.
            
            
               Article 32
                   Additional requirements to be fulfiled 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 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 six months from the date of entry into the Union, during which period the actions provided for in Article 138 of Regulation (EU) 2017/625 and in particular in its point (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, no cases or outbreaks of listed diseases referred to in the table set out in Part A of Annex 12 have been reported for the periods specified for those listed diseases in that table; 
            
            
               (b)as regards the area in and around the confined establishment, no cases or outbreaks of listed diseases referred to in the table set out in Part B of Annex 12 have been reported for the periods specified for those listed diseases in that table .
            
            
               Article 34
               Animal health requirements for 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 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 regarding the diseases referred to in the table set out in Part C of Annex 12, 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 specific guarantees set out in Part 12 of Annex 12.
            
            
               (d)they must not have been vaccinated as referred to in the table set out in Part E of Annex 12;
            
            
               (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, this facility must comply with the requirements set out in Part F of Annex 12.
            
            
               Article 35
                  Movement and handling of ungulates intended to confined establishments after the entry
            
            
               Following their entry into the Union, consignments of ungulates originating in a third country or territory, as referred to in Article 27, must remain in the confined establishment of destination for a period of at least 6 months prior to the date of movement to another confined establishment in the Union, unless they are exported from the Union or moved for slaughter.
            
            
               TITLE 3
                  ANIMAL HEALTH REQUIREMENTS FOR POULTRY AND CAPTIVE BIRDS 
            
            
               Chapter 1
                  Specific animal health requirements for poultry 
            
            
               SECTION 1 
                  ANIMAL HEALTH REQUIREMENTS FOR ALL SPECIES AND CATEGORIES OF POULTRY 
            
            
               Article 36 
                  Poultry imported into the third country or territory of origin or zone thereof prior to entry into Union
            
            
               1.The following consignments shall only be permitted to enter the Union where the competent authority of the third country or territory of origin has provided guarantees in accordance with paragraph 2 for:
            
            
               (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.The competent authority at the border inspection post as referred to in paragraph I shall verify that 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 the 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 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 six 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 2 to this Regulation; 
            
            
               or
            
            
               (ii)relevant Chapter of the Terrestrial Animal Health Code of the World Animal Health Organisation (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 13;
            
            
               (ii)the surveillance programme referred to in point (a) of this Article, in addition to the requirements set out in Annex 2, complies with the requirements set out in Part 2 of Annex 13;
            
            
               (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 14;
            
            
               (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 Part 1 of Annex 15; or
            
            
               (ii)the vaccines used comply with the general criteria for vaccines against infection with Newcastle disease virus set out in Part 1 of Annex 15 and the poultry meet the 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 Part 1 of Annex 15, set out in Part 2 of Annex 15;
            
            
               (f)it has undertaken that following any outbreak of highly pathogenic avian influenza or an outbreak of infection with Newcastle disease virus, to submit the following information to the Commission:
            
            
               (i)information on the disease situation within 24 hours of confirmation of any initial outbreak of highly pathogenic avian influenza or infection with Newcastle disease virus;
            
            
               (ii)regular updates on the disease situation; 
            
            
               (g)which has undertaken to submit virus isolates from initial outbreaks of highly pathogenic avian influenza and infection with Newcastle disease virus to the European Union Reference Laboratory for Avian Influenza and Newcastle disease.
            
            
               Article 38
                  Freedom from highly pathogenic avian influenza of the third country or territory of origin or zone thereof
            
            
               1.A third country or territory or zone thereof shall be considered as being free from highly pathogenic avian influenza when it has provided the following guarantees to the Commission:
            
            
               (a)a surveillance programme for highly pathogenic avian influenza, in accordance with Article 37(a) has been carried out during a period of at least 6 months preceding the date of certification of the consignment by the official veterinarian for dispatch to the Union; 
            
            
               (b)highly pathogenic avian influenza has not been present in the 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 of 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 three months following the completion of the stamping out policy and cleaning and disinfection referred to in points (a) and (b), the competent authority of the third country or territory has carried out a surveillance programme, providing at least the confidence by a randomised representative sample of the populations at risk to demonstrate the absence of infection taking into account the specific epidemiological circumstances in relation to the occurred outbreak(s), with negative results. 
            
            
               Article 39
                  Freedom from infection with Newcastle disease virus of the third country or territory of origin or zone thereof
            
            
               1.A third country or territory or zone thereof shall be considered free from infection with Newcastle disease virus when no outbreak of infection with Newcastle disease virus has occurred in poultry in that third country or territory or zone thereof for a period of at least 12 months preceding the date of certification of the consignment by the official veterinarian for dispatch to the Union; 
            
            
               2.When an outbreak of infection with Newcastle disease virus occurs in a third country or territory or zone thereof previously free from that disease, as referred to in paragraph 1, that third country or territory or zone thereof shall again be considered as free from that disease 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 three 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 they 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 Regulation (EU) 2019/… [reference to DA on registration of establishments and identification of animals], 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 they 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 they:
            
            
               (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 Regulation (EU) 2019/… as regards rules for establishments keeping terrestrial animals and hatcheries, and the traceability of certain kept terrestrial animals and hatching eggs [document SANTE 7016/2018]; and
            
            
               (i)the approval of which has not been suspended or withdrawn;
            
            
               (ii)within a 10 km radius of which, including, where appropriate, the territory of a neighbouring country, there has been no outbreak of highly pathogenic avian influenza or infection with Newcastle disease virus during the period of at least 30 days prior to the date of dispatch to the Union;
            
            
               (b)come from flocks which have been kept in establishments approved by the competent authority of the third country or territory of origin in accordance with requirements which are at least as stringent as to those laid down in Article 8 of Regulation (EU) 2019/… as regards rules for establishments keeping terrestrial animals and hatcheries, and the traceability of certain kept terrestrial animals and hatching eggs [document SANTE 7016/2018], and 
            
            
               (i)the approval 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 time 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 they 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 16;
            
            
               (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 they comply with the following requirements:
            
            
               (a)they not been vaccinated against infection with Newcastle disease virus;
            
            
               (b)they have been kept in isolation during a period of at least 14 days prior to the date of loading of the consignment for dispatch to the Union in the establishment of origin or quarantine establishment under the supervision of an official veterinarian, where:
            
            
               (i)no poultry has been vaccinated against infection with Newcastle disease virus during a period of at least 21 days prior to the date of loading of the consignment;
            
            
               (ii)no bird which does not form part of the consignment has entered into the establishment during period referred to in point (i); 
            
            
               (iii)no vaccination has been carried out.
            
            
               (c)they have tested negative, during the period of at least 14 days prior to the date of loading for dispatch to the Union, to serological tests to detect antibodies against Newcastle disease virus, performed on blood samples at a level which gives 95% confidence of detecting infection at 5% prevalence.
            
            
               2.Consignments of poultry intended for slaughter intended for a Member State with status-free from infection with Newcastle disease virus without vaccination, shall only be permitted to enter into the Union if they 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 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 they: 
            
            
               (a)have not been vaccinated against infection with Newcastle disease virus; 
            
            
               (b)come from hatching eggs coming from flocks which comply with one of the following: 
            
            
               (i)they have not been vaccinated against infection with Newcastle disease virus; or
            
            
               (ii)they have been vaccinated against infection with Newcastle disease virus using an inactivated vaccine; or
            
            
               (iii)they have been vaccinated against infection with Newcastle disease virus using a live vaccine at the latest 60 days prior to the date the eggs were collected.
            
            
               (c)come from a hatchery where working practices ensure that the eggs of day-old chicks intended for entry into the Union are incubated at completely separate times and locations from eggs not satisfying the requirements laid down in point (b).
            
            
               SECTION 2 
                  SPECIFIC ANIMAL HEALTH REQUIREMENTS FOR BREEDING AND PRODUCTIVE POULTRY 
            
            
               Article 43 
                  Identification of breeding ratites and production ratites 
            
         
         
            
               Consignments of breeding ratites and production ratites shall only be permitted to enter into the Union if they are individually identified by neck-tags or microchips:
            
            
               (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 they originate from flocks which comply with the following requirements:
            
            
               (a)the flocks have not been vaccinated against highly pathogenic avian influenza;
            
            
               (b)where 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 Part 1 of Annex 15;
            
            
               or
            
            
               –the general criteria for vaccines against infection with Newcastle disease virus set out in Part 1 of Annex 15, and the poultry meet the 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 Part 1 of Annex 15, set out in Part 2 of Annex 15;
            
            
               (ii)the information set out in Part 4 of Annex 15 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 Regulation (EU) 2019/… [reference to DA on registration of establishments and identification of animals], 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; and
            
            
               (iii)Salmonella Pullorum and Salmonella Gallinarum in case of Numida meleagris, Coturnix coturnix, Phasianus colchicus, Perdix perdix, Anas spp.
            
            
               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 they originate from flocks which comply with the following requirements:
            
            
               (a)they have not been vaccinated against highly pathogenic avian influenza; 
            
         
         
            
               (b)if they have been vaccinated against infection with Newcastle disease virus:
            
            
               (i)guarantees have been provided by the competent authority of the third country or territory of origin that:
            
            
               –the vaccines used comply with the general and the specific criteria for vaccines against infection with Newcastle disease virus set out in Part 1 of Annex 15; 
            
            
               or
            
            
               –the vaccines used comply with the general criteria for vaccines against infection with Newcastle disease virus set out in Part 1 of Annex 15 and the poultry meet the 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 Part 1 of Annex 15, set out in Part 2 of Annex 15;
            
            
               (ii)the information set out in Part 4 of Annex 15 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 they 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 13, 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 Part 1 of Annex 15; or
            
            
               –the general criteria for recognised vaccines against infection with Newcastle disease virus set out in Part 1 of Annex 15 and the poultry and hatching eggs from which the day-old chicks originated meet the 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 Part 1 of Annex 15, set out in Part 2 of Annex 15;
            
            
               (ii)the information set out in Part 4 of Annex 15 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 Regulation (EU) 2019/… [reference to DA on registration of establishments and identification of animals] 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.
            
            
               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 they originate from hatching eggs which:
            
            
               (a)comply with the animal health requirements for entry into the Union laid down in Title 2 of Part III;
            
            
               (b)prior to being dispatched to the hatchery, the hatching eggs had been marked in accordance with the instruction of the competent authority;
            
            
               (c)had been disinfected in accordance with the instructions of the competent authority;
            
            
               (d)have had no contact with poultry or hatching eggs of a lower health status, captive birds or wild birds, either during transport to the hatchery or in the hatchery.
            
            
               Article 48
                  Specific animal health requirements for the day-old chicks
            
            
               Consignments of day-old chicks shall only be permitted to enter into the Union if they 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 derogation from Article 14(3), Articles 17, 18, 40 and 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 they 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 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 13 have been provided by the third country or territory of origin;
            
            
               (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 Part 1 of Annex 15; or
            
         
         
            
               –the general criteria for vaccines against infection with Newcastle disease virus set out in Part 1 of Annex 15 and the poultry meet the 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 Part 1 of Annex 15, set out in Part 2 of Annex 15;
            
            
               (ii)the information set out in Part 4 of Annex 15 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 of 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 before the entry into the union, set out in Annex 17;
            
            
               (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; and
            
            
               (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, production poultry, except production 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 
            
            
               (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, production poultry, except production 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 at 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 18. 
            
         
         
            
               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, production 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;
            
            
               (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.
            
            
               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 they are identified with an individual identification number by means of a unique marked closed leg-ring or a microchip, 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 they are to be 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 16; 
            
            
               (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 they 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 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 been diagnosed 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 point (iii); 
            
            
               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 regranting 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 they 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 19:
            
            
               (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 they 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 plan; 
            
            
               (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 are taken, in accordance with the requirements of [C(2019)4057, (EU) 2019/… of … 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] shall be implemented.
            
            
               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 they:
            
            
               (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 Part 1 of Annex 15;
            
            
               (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.
            
            
               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 Regulation (EU 2019/… as regards animal health requirements for movements within the Union of terrestrial animals and hatching eggs [document C(2019)4058], as follows:
            
            
               (a)the total journey from the point of entry into the Union to the quarantine establishment must not exceed nine 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: 
            
            
               (i)a minimum number of 10 sentinel birds are used in each unit of the approved quarantine centre; 
            
            
               (ii)they are at least three 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.
            
            
               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 20. 
            
         
         
            
               Article 62
                  Release of the captive birds from quarantine 
            
            
               The operator of the quarantine establishment referred to in Article 59 shall only release the captive birds from quarantine on the written authorisation an official veterinarian.
            
            
               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 honey bees shall be permitted to enter the Union:
            
            
               (a)queens of honeybees; 
            
            
               (b)bumble bees.
            
            
               Article 64
                  Dispatch to the Union of honeybees and bumble bees
            
            
               Consignments of queens of 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 feed products 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 before 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, small hive beetle and Tropilaelaps mite in any of their life stages; and
            
            
               (ii)in the case of bumble bees, small hive beetle, in any of their life stages.
            
            
               Chapter 2
                  Specific animal health requirements for honeybees
            
            
               Article 65
                  The apiary of origin of honeybees
            
         
         
            
               Consignments of queen bees of honeybees shall only be permitted to enter the Union if they originate from an apiary which is situated in an area: 
            
            
               (a)of at least a 100 km radius, including where appropriate the territory of a neighbouring third country:
            
            
               (i)where no case or outbreak of small hive beetle or of Tropilaelaps mite has 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)no case or outbreak of American foulbrood has 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, case or outbreak of American foulbrood disease during the period referred to in point (i); 
            
            
               (iii)where there had been a previous outbreak 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 honeybees
            
            
               Consignments of queens of honeybees shall only be permitted to enter the Union if they 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 honeybees
            
            
               Consignments of queens of honeybees shall only be permitted to enter the Union if they are in closed cages, each containing one single queen bee with a maximum of 20 accompanying attendants.
            
            
               Article 68
                  Additional guarantees for honeybees destined to certain Member States or zone as regards the infestation with the varroa spp.
            
            
               Consignments of queen bees of honeybees destined to a Member State or zone with disease-free status for varroa spp. shall only be permitted to enter the Union if they comply with the following requirements: 
            
            
               (a)the animals must originate from a third country or territory or zone thereof free of infestation with varroa spp.;
            
            
               (b)in the third country or territory of origin or zone thereof, no case of infestation with varroa spp. has 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 infestation with varroa spp. during loading and dispatch to the Union.
            
            
               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 they:
            
         
         
            
               (a)have been bred and kept in an environmentally isolated bumblebee 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;
            
            
               (iii)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 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 they 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 honeybees and bumble bees
            
            
               Article 71
               Handling after the entry of honeybees and bumble bees
            
            
               1.Following their entry into the Union, queens of 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 for the presence of the small hive beetle, including eggs and larvae, and any signs of the Tropilaelaps mite.
            
            
               3.Operators receiving bumble bees shall destroy their 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 the consignment of honeybees or bumble bees referred to in Article 64 shall:
            
            
               (a)supervise the transfer from the transport cage to new cages referred Article 71(1);
            
            
               (b)ensure the submission by the operator of the materials referred to in Article 71(2); 
            
            
               (c)have arrangements in place which ensure that the official laboratory referred to in Article 71(2) destroys the cages, attendants and the material after the laboratory examination provided for in that provision.
            
            
               TITLE 5
                  ANIMAL HEALTH REQUIREMENTS FOR THE ENTRY INTO THE UNION OF DOGS, CATS AND FERRETS 
            
            
               Article 73
                  Dispatch of the dogs, cats and ferrets to the Union
            
         
         
            
               Consignments of dogs, cats and ferrets shall only be permitted to enter the Union if they have been dispatched directly from their establishment of origin to the Union, or if they transited through a third country or territory or zone thereof which is listed for the entry of dogs, cats and ferrets into the Union.
            
            
               Article 74
                  Identification of dogs, cats and ferrets
            
            
               1.Consignments of dogs, cats and ferrets shall only be permitted to enter the Union if they 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 Regulation (EU) 2019/… [reference to Implementing Regulation on identification].
            
            
               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 the 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 they originate from a third country or territory or zone thereof where rules on the prevention and control of rabies 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 they comply with the following requirements: 
            
            
               (a)they have received a rabies vaccination that complies with the following conditions:
            
            
               (i)the animals must be at least 12 weeks old at the time of vaccination;
            
            
               (ii)the vaccine must comply with the requirements set out in Annex III to Regulation (EU) No 576/2013 of the European Parliament and of the Council;
            
            
               (iii)at the day of dispatch to the Union, 21 days must have elapsed since the completion of the primary rabies vaccination;
            
            
               (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 21.
            
            
               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 577/2013 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 they have been treated against this infestation in accordance with Part 2 of Annex 21.
            
            
               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 they 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. 
            
            
               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 six months from the date of their arrival in the case of non-compliance with the requirements for rabies vaccination 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(2), 24 hours following a treatment against infestation with Echinococcus multilocularis in accordance with point 2 of Annex 21. 
            
            
               Part III
                  Animal health requirements for the 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 the 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.
            
            
               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 products 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 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 center; 
            
            
               (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 center.
            
            
               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 aplha-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 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].
            
            
               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 transport 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 transport container referred to in point (a).
            
            
               2.By the way of derogation from paragraph 1(b), operators may place in one transport 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 transport 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 if they were collected from animals shall only be permitted to enter the Union if they come from establishments:
            
            
               (a)which comply with the requirements of Article 23;
            
            
               (b)in the case of donor animals of semen prior to their admission to a quarantine accommodation, which were free from the following diseases and have never been kept previously in any establishment of a lower health status:
            
            
               (i)infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis);
            
            
               (ii)infection with Brucella abortus, Brucella melitensis and Brucella suis;
            
            
               (iii)enzootic bovine leukosis;
            
            
               (iv)infectious bovine rhinotracheitis/ infectious pustular vulvovaginitis.
            
         
         
            
               Article 87
                  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 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].
            
            
               Article 88
                  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 less 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 and provided that 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.
            
            
               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, Brucella melitensis and Brucella suis in accordance with requirements laid down in Chapter IV of Part 5 of Annex II to 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, Brucella melitensis and Brucella suis for a period of at least the three 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 three 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.
            
            
               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 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 be 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, Brucella melitensis and Brucella 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 Brucella abortus, Brucella melitensis and Brucella 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 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 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(3), and the additional specific animal health requirements laid down in Part 4 of Annex II to 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).
            
            
               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 symptoms suggesting the presence of any of the diseases referred to in point (b) or disease symptoms of such diseases, 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 22, and during that time the flock of origin has:
            
            
               (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 before 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 they 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 the 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 the 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; 
            
            
               (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, which must comply 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 points (a) and (b). 
            
            
               Article 101
               Transport by vessel of hatching eggs
            
            
               1.Consignments of hatching eggs shall only be permitted to enter the Union if they comply with the following requirements: 
            
            
               (a)hatching eggs which were transported by ship, even for part of the journey, to the Union must:
            
            
               (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 of department 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 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, immediately before every transport of, hatching eggs or any item representing an animal health risk, and, if necessary, disinfected again and in any case dried or allowed to dry before any new loading of hatching eggs.
            
            
               (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;
            
            
               (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 16.
            
            
               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 arrival 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 origin 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 the 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 which the following requirements: 
            
            
               (a)it has a disease surveillance programme for highly pathogenic avian influenza in place for a period of at least six 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 2 to this Regulation; 
            
            
               or
            
            
               (ii)relevant Chapter of the Terrestrial Animal Health Code of the World Animal Health Organisation (OIE); 
            
            
               (b)which is considered to be free from highly pathogenic avian influenza in accordance with Article 38;
            
            
               (c)where it carries 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 13; 
            
            
               (ii)the surveillance programme referred to in point (a) of this Article, in addition to the requirements set out in Annex 2, complies with the requirements set out in Part 2 of Annex 13;
            
            
               (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 14;
            
            
               (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 Part 1 of Annex 15; 
            
            
               or
            
            
               (ii)the vaccines used comply with the general criteria for vaccines against infection with Newcastle disease virus set out in Part 1 of Annex 15 and the poultry meet the 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 Part 1 of Annex 15, set out in Part 2 of Annex 15;
            
            
               (f)it has undertaken that following any outbreak of highly pathogenic avian influenza or an outbreak of infection with Newcastle disease virus, to submit the following information to the Commission:
            
            
               (i)information on the disease situation within 24 hours of confirmation of any initial outbreak of highly pathogenic avian influenza or infection with Newcastle disease virus;
            
            
               (ii)regular updates 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 Regulation (EU) 2019/… [reference to DA on registration of establishments and identification of animals]; 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 Regulation (EU) 2019/… [reference to DA on registration of establishments and identification of animals] 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 time 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 time of collection of the eggs for dispatch to the Union;
            
         
         
            
               (iv)which have been assigned a unique approval number by the competent authority of the third country or territory of origin.
            
            
               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 programmes and additional surveillance set out in Annex 13, 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 Part 1 of Annex 15; or
            
            
               –the general criteria for recognised vaccines against infection with Newcastle disease virus set out in Part 1 of Annex 15 and the poultry and hatching eggs from which the day-old chicks originated meet the 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 Part 1 of Annex 15 set out in Part 2 of Annex 15;
            
            
               (ii)the information set out in Part 4 of Annex 15 must be provided for each consignment;
            
            
               (c)they have undergone a disease surveillance programme that meets the requirement set out Annex II of Regulation (EU) 2019/… [reference to DA on registration of establishments and identification of animals] 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 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 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 1 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 13, 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 either with: 
            
            
               –the general and the specific criteria for vaccines against infection with Newcastle disease virus set out in Part 1 of Annex 15;
            
         
         
            
               or
            
            
               –the general criteria for vaccines against infection with Newcastle disease virus set out in Part 1 of Annex 15 and the hatching eggs meet the 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 Part 1 of Annex 15 set out in Part 2 of Annex 15;
            
            
               (ii)the information set out in Part 4 of Annex 15 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;
            
            
               (ii)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.
            
            
               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 originate from flocks which comply with the requirements set out in one of the following points:
            
            
               (a)they have not been vaccinated against infection with Newcastle disease virus; 
            
            
               or
            
            
               (b)they have been vaccinated against infection with Newcastle disease virus using an inactivated vaccine; 
            
            
               or
            
            
               (c)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 time 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 time 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 time 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 vaccination programmes and additional surveillance set out in Annex 13, have been provided by the third country or territory of origin;
            
            
               (c)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 Part 1 of Annex 15; or
            
            
               –the general criteria for recognised vaccines against infection with Newcastle disease virus set out in Part 1 of Annex 15 and the hatching eggs meet the 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 Part 1 of Annex 15, set out in Part 2 of Annex 15;
            
            
               (ii)the information set out in Part 4 of Annex 15 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 shipment 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 1 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 before the entry into the union, set out in Annex 17:
            
            
               –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; and
            
            
               –Salmonella Pullorum and Salmonella Gallinarum in case of Numida meleagris, Coturnix coturnix, Phasianus colchicus, Perdix perdix, Anas spp.
            
            
               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 time 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 time 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 time 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 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.
            
            
               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 and hatchers from other hatching eggs; 
            
            
               or
            
            
               (b)incubators and 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 and 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 or 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.
            
            
               Article 113
                  Sampling and testing following the entry into the Union 
            
            
               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 must 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 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 shall be 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.
            
            
               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 poultry 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:
            
            
               (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 and 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 62.
            
            
               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 the entry into the Union of consignments of germinal products of animals other than those referred to in point (g) of Article 1(5) dispatched from confined establishments
            
            
               Consignments of semen, oocytes and embryos of animals other than those referred to in point (g) of Article 1(5) 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;
            
            
               (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 the 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 symptoms suggesting the presence of any of the diseases referred to in point (b) or clinical signs of such diseases, 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 aplha-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.
            
            
               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 constrains for the date of production 
            
            
               1.Consignments of products of animal origin shall only be permitted to enter the Union if they were not obtained during a period where:
            
            
               (a)animal health restriction measures were adopted by the Union for the entry of such products from the third country or territory of origin or zone thereof;
            
            
               (b)the authorisation for the 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 they 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 the 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 26;
            
            
               (ii)risk mitigating treatments for dairy products set out in Annex 27;
            
            
               (iii)risk mitigating treatments for egg products set out in Annex 28.
            
            
               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 they 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 origin to the Union.
            
            
               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 they 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 the entry into the Union provided for in this Regulation.
            
            
               TITLE 2
                  ANIMAL HEALTH REQUIREMENTS FOR THE 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 they have been obtained from kept animals which comply with the following requirements:
            
            
               (a)the kept animals were dispatched directly from their establishment of origin to a slaughterhouse situated in the same listed third country or territory or zone; 
            
            
               (b)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 the 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. 
            
            
               (c)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 they have been obtained from carcasses which comply with the following requirements:
            
            
               (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 the 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 they have 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 1 and the absence 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 they originate from animals which had no contact with animals of a lower animal 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 the entry into the Union of fresh meat, provided for in Articles 124 to 146, throughout the operations of slaughter, cutting and until either:
            
            
               (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 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 Bos taurus, Ovis aries, Capra hircus and Equus caballus, not including Equus caballus hippotigris (zebras).
            
            
               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 before slaughter or killing of the kept of the kept ungulates of origin of the fresh meat
            
            
               1.The kept ungulates of origin of the fresh meat intended for the 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 the entry into the Union of fresh meat from the same species of ungulates and the kept ungulates remained there for at least three months prior to slaughter; or
            
            
               (b)a Member State.
            
            
               2.The kept ungulates of origin of the fresh meat intended for the entry into the Union other than those referred to in paragraph 1, must comply, immediately prior to the date of slaughter or killing, with a residency period for a continuous period of time in accordance with Annex 23 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(a), consignments of fresh meat of kept ungulates not complying with those requirements shall be permitted to enter the Union provided that the fresh meat was obtained from ungulates of the species Bos taurus, Ovis aries, Capra hircus and Equus caballus, not including Equus caballus hippotigris (zebras), 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 before 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 they originate 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 24, 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 24 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 they originate 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 25.
            
            
               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 provided for in points 1.1(b) or 3.1.1(a) in Part B of Annex 25 which 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.
            
            
               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 they have been obtained from ungulates which come from an establishment: 
            
            
               (a)in and around which, including where appropriate the territory of a neighbouring country, no case or outbreak of the listed diseases referred to in Part A of Annex 24, for which the species of ungulates of origin of the fresh meat intended for the 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 before the date of slaughter set out in points 1.1(b) or 3.1.1(a) of Part B of Annex 25 which must have been specifically assigned by the Commission in the list to the third country or territory or zone thereof authorised for the 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 they have been obtained from ungulates which come from an establishment: 
            
            
               (a)where no animals have been vaccinated according to Part A of Annex 25; or
            
            
               (b)the third country or territory of origin or zone thereof complies with the specific conditions to be provided by the competent authority where the third country or territory or zone thereof has been free of disease for less than 12 months before the date of slaughter, set out in point 1 of Part B of Annex 24, which must have been specifically assigned by the Commission in the list to the third country or territory or zone thereof listed for the 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 they originate 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 they were obtained in a slaughterhouse, or in a game handling establishment, in and around which there has been no case or outbreak of the listed diseases referred to in Part A of Annex 24 in an area of 10 kilometres, 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.
            
            
               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 they originate 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 if they were obtained from animals which comply with the following requirements: 
            
            
               (a)they were killed at a distance that exceeds 20 kilometres from the border of any third country or territory or zone thereof which at that time was not listed for the entry into the Union of fresh meat of the species of wild ungulates; 
            
            
               (b)they were killed in an area of 20 kilometres radius, where, during the preceding 60 days, there were no restrictions due to a case or outbreak of the diseases referred to in Part A of Annex 24.
            
         
         
            
               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 they have obtained in a game handling establishment in and around which there has been no case or outbreak of the listed diseases referred to in Part A of Annex 24 in an area of 10 kilometres, 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 wild 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 they have been obtained from poultry which:
            
            
               (a)has 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
            
            
               (b)was 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 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 six 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)set out in Annex 2 to this Regulation; 
            
            
               or
            
            
               (ii)relevant Chapter of the Terrestrial Animal Health Code of the World Animal Health Organisation (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, 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 13;
            
            
               (ii)the surveillance programme referred to in point (a) of this Article, in addition to the requirements set out in Annex 2, complies with the requirements set out in Part 2 of Annex 13;
            
            
               (iii)it has undertaken to inform the Commission of any change to the vaccination plan 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;
            
            
               (i)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 virus in relation to isolation, surveillance and testing, as set out in Annex 14;
            
            
               (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 Part 1 of Annex 15; or
            
            
               (ii)the vaccines used comply with the general criteria for vaccines against infection with Newcastle disease virus set out in Part 1 of Annex 15 and the poultry meet the 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 Part 2 of Annex 15;
            
            
               (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 they originate from poultry which come from an establishment:
            
            
               (a)in which and within a 10 kilometres 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 14.
            
            
               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 they have been obtained from poultry which has not been vaccinated against highly pathogenic avian influenza or infection with Newcastle disease virus, or they 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 programmes and additional surveillance set out in Annex 13, 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 Part 1 of Annex 15; or
            
            
               –the general criteria for recognised vaccines against infection with Newcastle disease virus set out in Part 1 of Annex 15 and the poultry and hatching eggs from which the day-old chicks originated meet the animal health requirements in relation to vaccination, isolation, testing and contact with other poultry set out in Part 2 of Annex 15;
            
            
               (ii)the information set out in Part 5 of Annex 15 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 it originates from poultry which has 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 they originate 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; 
            
            
               (a)within a 10 kilometre 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.
            
            
               Section 3
                  Specific animal health requirements for fresh meat of wild game birds
            
            
               Article 145
                  The third country or territory of origin or zone thereof of the fresh meat of wild game birds
            
            
               Consignments of fresh meat of wild game birds 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 six 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 2 to this Regulation; 
                  or
            
            
               (ii)in the relevant Chapter of the Terrestrial Animal Health Code of the World Animal Health Organisation (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 wild game birds
            
            
               Consignments of fresh meat of wild game birds shall only be permitted to enter the Union if they come 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 kilometres 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 they have been treated in accordance with Article 121 as required in Articles 148 or 149.
            
            
               Article 148
                  Meat products not subject to a risk mitigating treatment
            
            
               Consignments of meat products shall only be permitted to enter the Union if they have not undergone a risk mitigating treatment in accordance with Annex 26 where: 
            
            
               (a)the third country or territory of origin or zone thereof is listed for the 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 the 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 the entry into the Union of fresh meat and therefore was eligible for the entry into the Union and originated from; 
            
            
               (i)the third country or territory or zone thereof where the meat product was processed; 
            
            
               (ii)a listed third country or territory or zone thereof which is listed for the 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 26 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 26, 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 the 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 26, where the fresh meat used for the processing of the meat products originates from a third country or territory or zone thereof:
            
         
         
            
               (a)listed for the 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 kilometres radius, including where appropriate the territory of a neighbouring country, there has been no case or outbreak of a listed disease, relevant for the species of origin of the meat products in accordance with Annex 1, 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.
            
            
               Article 152
                  Specific requirements for the entry into the Union of casings
            
            
               Consignments of casings shall only be permitted to enter the Union if they have undergone the following risk mitigating treatments set out in Part 2 of Annex 26:
            
            
               (a)treatments ‘Casing 1’ or ’ Casing 2’, where the bladders and intestines used for the processing of the casings originate from animals of the species Bos taurus, Ovis aries, Capra hircus or kept Sus scrofa; 
            
            
               (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 THE 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 and colostrum 
            
            
               Consignments of raw milk, colostrum and colostrum based products shall only be permitted to enter the Union if they originate from a third country or territory or zone thereof which has been free from:
            
            
               (a)foot and mouth disease for a period of at least 12 months prior to the date of milking, and during that period of time no vaccination against that disease has been carried out; 
            
            
               (b)rinderpest for a period of 12 months prior to the date of milking.
            
         
         
            
               Article 154
                  The animals of origin of the raw milk and colostrum 
            
            
               Consignments of raw milk, colostrum and colostrum based products shall only be permitted to enter the Union if they were obtained from animals of the species Bos taurus, Ovis aries, Capra hircus, Bubalus bubalis or Camelus dromedarius that complied with a residency period of at least 3 months, prior to the date of milking, in the third country, territory or zone thereof of milking. 
            
            
               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 they have been treated as required in Article 156 or 157.
            
            
               Article 156
                  Dairy products not subject to a risk mitigating treatment
            
            
               Consignments of dairy products which have not undergone a risk mitigating treatment of those set out in Annex 27 shall only be permitted to enter the Union if they comply with following requirements:
            
            
               (a)they were obtained from animals of the species Bos taurus, Ovis aries, Capra hircus, Bubalus bubalis and Camelus dromedarius; 
            
            
               (b)the third country or territory of origin or zone thereof is listed for the entry into the union of raw milk and colostrum of the relevant species; and
            
            
               (c)the raw milk used for the processing of the dairy products complied with all the requirements for the entry into the Union of raw milk laid down in this Regulation, and therefore was eligible for the 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 the 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 shall only be permitted to enter the Union if they have undergone at least one of the risk mitigating treatments provided for in column A of Annex 27, 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 for the period of 12 months preceding the date of dispatch of the consignment to the Union or where in the same period vaccination against foot and mouth disease has been practised. 
            
            
               2.Consignments of dairy products shall only be permitted to enter the Union if they have undergone at least one of the risk mitigating treatments provided for in column B of Annex 27 where they were processed 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 they have undergone either:
            
            
               (a)at least the most severe of the risk mitigating treatments assigned in the list to the different 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 by the Union in the list 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 they 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 lestablished in either:
            
            
               (a)Annex 2 to this Regulation; 
            
            
               or
            
            
               (b)the relevant Chapter of the Terrestrial Animal Health Code of the World Animal Health Organisation (OIE).
            
            
               Article 159
                  The establishment of origin of the eggs
            
            
               Consignments of eggs shall only be permitted to enter the Union if they 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 the 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 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 the entry into the Union.
            
            
               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 they 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 2 to this Regulation; 
            
            
               or
            
            
               (b)relevant Chapter of the Terrestrial Animal Health Code of the World Animal Health Organisation (OIE).
            
            
               Article 161
                  The establishment of origin of the eggs
            
            
               Consignments of egg products shall only be permitted to enter the Union if they 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 Part 1 of Annex 28.
            
            
               (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 Part 2 of Annex 28.
            
            
               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 they come from a third country or territory or zone thereof listed for the 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 the entry into the Union of products of animal origin laid down in Part 1 of this Regulation;
            
            
               (ii)the animal health requirements for the entry into the Union of the specific product of animal origin, as laid down in Titles 1 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 the 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 the 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 27;
            
            
               (ii)risk mitigating treatments for egg products set out in in Annex 28;
            
            
               (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 THE ENTRY INTO THE UNION OF PRODUCTS OF ANIMAL ORIGIN INTENDED FOR PERSONAL USE
            
            
               Article 164
                  Derogation from animal health requirements and additional requirements for the 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 they: 
            
            
               (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 they are intended for personal use and originate from neighbouring third countries or territories listed for the 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 the 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 
            
            
               TITLE 1
                  GENERAL ANIMAL HEALTH REQUIREMENTS FOR the 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 shall only be permitted to enter the Union if they 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 including aquatic animals intended for human consumption and products of animal origin from aquatic animals other than live aquatic animals 
            
            
               Consignments of aquatic animals including aquatic animals intended for human consumption and products of animal origin from aquatic animals other than live aquatic animals, shall only be permitted to enter the Union if they 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 the entry of the particular species and category of aquatic animals into the Union; 
            
            
               (c)they have not have 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 transport 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 :
            
            
               (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 kilometres 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 including those intended for human consumption, 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 they 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 including those intended for human consumption shall only be permitted to enter the Union if they 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 boxes in the consignment;
            
            
               (b)the name of the species present in each box;
            
            
               (c)the number of animals in each box 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, or when transported by sea, an entry in the vessel's manifest, 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;
            
            
               (ii)bi-valve molluscs intended for human consumption in the European Union;
            
            
               (iii)crustaceans intended for human consumption in the European Union.
            
            
               Article 170
                  Animal health status of the third country or territory of origin or zone or compartment thereof 
            
            
               Consignments of aquatic animals including those intended for human consumption and products of animal origin from aquatic animals other than live aquatic animals shall only be permitted to enter the Union if they 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 29 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.
            
            
               Article 171
                  Vector species
            
            
               Aquatic animals listed in column 4 of 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 30. 
            
            
               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, 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 aer to be processed fopr human consumption;
            
            
               (b)fish intended for human consumption which were slaughtered and eviscerated before dispatch to the Union.
            
            
               Article 174
                  Handling of aquatic animals and products of animal origin from 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 and products of animal origin from aquatic animals other than live 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 the entry of the aquatic animals and products of animal origin from 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 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 the entry of certain commodities as referred to in Articles 3 and 5 for which the Union is not the final destination and for the 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 the 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 set out in the list, specifically assigned 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 the 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 set out in the list, specifically assigned 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 and paragraph 2(b) shall be 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;
            
            
               (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 constrains; 
            
            
               (d)
                     established trade routes; 
            
            
               (e)
                     other relevant factors.
            
            
               Article 177
                  Additional requirements for the entry of 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 cultural events 
            
            
               1.Consignments of registered horses temporarily exported from a Member State to third countries or territories or zones thereof listed for the 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 not exceeding 90 days and specified for the different purposes by the Commission;
            
            
               (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 11, 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 the 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 the 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:
            
            
               (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) …/… reference to SANTE/7146/2018.
            
            
               Article 179
               Special requirements for the 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
            
            
               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 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: 
            
            
               (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 transport boxes, 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) …/…  reference to SANTE/7146/2018.
            
            
               Article 180
                  Special requirements for the 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 products of animal origin which are packaged, 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:
            
            
               (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 packaging of the germinal products or 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) …/…  reference to SANTE/7146/2018.
            
            
               Article 181
                  Special requirements for the 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
            
            
               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 country is a listed country for 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 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) …/…  reference to SANTE/7146/2018.
            
            
               Article 182
                   Special requirements for the entry of unpackaged or in bulk products of animal origin, 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 the 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) …/…  reference to SANTE/7146/2018.
            
            
               Part VII
                  Transitional and final provisions
            
            
               Article 183
                  Repeals
            
            
               The following acts are repealed as from 21 April 2021:
            
            
               –Regulation (EU) No 206/2010;
            
            
               –Implementing Regulation (EU) No 139/2013; 
            
            
               –Regulation (EU) No 605/2010; 
            
            
               –Regulation (EC) No 798/2008; 
            
            
               –Decision No 2007/777/EC; 
            
            
               –Regulation (EC) No 119/2009; 
            
            
               –Regulation (EC) No 206/2009; 
            
            
               –Regulation (EU) No 28/2012; 
            
            
               –Regulation (EU) No 2016/759.
            
            
               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,
            
            
               
                     For the Commission
               
               
                     The President
               
               
                     Jean-Claude JUNCKER
               
            
         
         
      
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               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 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 haemorragic 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, relevant for the listed species of poultry and captive birds in the Annex to Regulation (EU) 2018/1882, from which germinal products authorised to enter the Union are obtained.
            
            
               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 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
            
         
         
            
               –Infection with Taura syndrome virus
            
            
               –Infection with yellow head virus
            
            
               –Infection with white spot syndrome virus
            
            
               ANNEX II
            
            
               MINIMUM INFORMATION FOR DISEASE SURVEILLANCE PROGRAMMES 
            
            
               (referred to in Article 10)
            
            
               The submission of a disease surveillance programme should include at least the following information:
            
            
               (a)a description of the epidemiological situation of the disease before the date of beginning of the implementation of the surveillance programme, and data on the epidemiological evolution of the disease;
            
            
               (b)the targeted animal population, epidemiological units and zones of the surveillance programme;
            
            
               (c)the organisation of the competent authority, supervision of the implementation of the surveillance programme and official controls to be applied during the implementation of the programme and 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.
            
            
               ANNEX III
            
            
               Table 1. Requirements as regards the residency periods for ungulates, bees and bumblebees before their entry into the Union 
            
            
                     
                        Species and category of animals
                     
                  
                  
                     
                        Minimum residency period in the third country or territory of origin or zone thereof, as referred to Article 11(2)(a)
                     
                  
                  
                     
                        Minimum residency period in the establishment of origin, as referred to in Article 11(2)(b)
                     
                  
                  
                     
                        Minimum period without contact with animals of a lower health status as referred to in Article 11(2)(c)
                     
                  
               
                     
                        Bovine, ovine, caprine and porcine animals
                     
                  
                  
                     
                        6 months or since birth, if the animals are less than 6 months of age
                     
                  
                  
                     
                        40 days, or since birth, if the animals are less than 40 days of age
                     
                  
                  
                     
                        30 days, or since birth, if the animals are less than 30 days of age
                     
                  
               
                     
                        Bovine, ovine, caprine and porcine animals intended for slaughter
                     
                  
                  
                     
                        3 months, or since birth if the animals are less than 3 months of age
                     
                  
                  
                     
                        40 days, or since birth, if the animals are less than 40 days of age
                     
                  
                  
                     
                        30 days, or since birth, if the animals are less than 30 days of age
                     
                  
               
                     
                        Equine animals other than registered horses intended for competition, races or invited 
                     
                     
                        for specific cultural events
                     
                  
                  
                     
                        3 months, or since birth if the animals are less than 3 months of age 
                     
                  
                  
                     
                        30 days or since birth, if the animals are less than 30 days of age
                     
                  
                  
                     
                        15 days
                     
                  
               
                     
                        Registered horses intended for competition, races or invited 
                     
                     
                        for specific cultural events
                     
                  
                  
                     
                        40 days
                     
                  
                  
                     
                        40 days
                     
                  
                  
                     
                        40 days
                     
                  
               
                     
                        Ungulates other than bovine, ovine, caprine, porcine and equine animals
                     
                  
                  
                     
                        6 months or since birth, if the animals are less than 6 months of age
                     
                  
                  
                     
                        40 days, or since birth, if the animals are less than 40 days of age
                     
                  
                  
                     
                        6 months or since birth, if the animals are less than 6 months of age
                     
                  
               
                     
                        Honeybees and bumblebees
                     
                  
                  
                     
                        Since hatching
                     
                  
                  
                     
                        Since hatching
                     
                  
                  
                     
                        Since hatching
                     
                  
               
               Table 2. Requirements as regards the residency periods of poultry and captive birds before their entry into the Union
            
            
                     
                        Category of birds
                     
                  
                  
                     
                        The residency period applies to
                     
                  
                  
                     
                        Minimum residency period in the third country or territory of origin or zone thereof, as referred to Article 11(2)(a)
                     
                  
                  
                     
                        Minimum residency period in the establishment of origin, as referred to Article 11(2)(b)
                     
                  
                  
                     
                        Minimum period without contact with animals of a lower health status as referred to in Article 11(2)(c)
                     
                  
               
                     
                        Breeding poultry
                     
                  
                  
                     
                        AC
                     
                  
                  
                     
                        3 months or since hatching, if the animals are less than 3 months of age
                     
                  
                  
                     
                        6 weeks, or since hatching, if the animals are less than 6 weeks of age
                     
                  
                  
                     
                        6 weeks, or since hatching, if the animals are less than 6 weeks of age
                     
                  
               
                     
                        Productive poultry for the production of meat and eggs for consumption
                     
                  
                  
                     
                        AC
                     
                  
                  
                     
                        3 months, or since hatching, if the animals are less than 3 months of age
                     
                  
                  
                     
                        6 weeks, or since hatching, if the animals are less than 6 weeks of age
                     
                  
                  
                     
                        6 week, or since hatching, if the animals are less than 6 weeks of age
                     
                  
               
                     
                        Productive poultry for restocking supplies of game birds
                     
                  
                  
                     
                        AC
                     
                  
                  
                     
                        6 weeks, or since hatching, if the animals are less than 6 weeks of age
                     
                     
                  
                  
                     
                        30 days, or since hatching
                     
                  
                  
                     
                        30 days, or since hatching 
                     
                     
                  
               
                     
                        Poultry intended for slaughter
                     
                  
                  
                     
                        AC
                     
                  
                  
                     
                        6 weeks, or since hatching, if the animals are less than 6 weeks of age
                     
                     
                  
                  
                     
                        30 days, or since hatching 
                     
                  
                  
                     
                        30 days, or since hatching
                     
                     
                     
                  
               
                     
                        Day-old chicks
                     
                  
                  
                     
                        AC
                     
                  
                  
                     
                        Since hatching
                     
                  
                  
                     
                        Since hatching
                     
                  
                  
                     
                        Since hatching
                     
                  
               
                     
                  
                  
                     
                        FO
                     
                  
                  
                     
                        3 months
                     
                  
                  
                     
                        6 weeks
                     
                  
                  
                     
                        -
                     
                  
               
                     
                        Less than 20 breeding poultry, productive poultry and poulry intended for slaughter other than ratites
                     
                  
                  
                     
                        AC
                     
                  
                  
                     
                        l3 months, or since hatching, if the animals are less than 3 months of age
                     
                  
                  
                     
                        3 weeks, or since hatching, if the animals are less than 3 weeks of age
                     
                  
                  
                     
                        3 weeks, or since hatching, if the animals are less than 3 weeks of age
                     
                  
               
                     
                        Less than 20 day-old chicks other than ratites
                     
                  
                  
                     
                        AC
                     
                  
                  
                     
                        Since hatching
                     
                  
                  
                     
                        Since hatching
                     
                  
                  
                     
                        Since hatching
                     
                  
               
                     
                  
                  
                     
                        FO
                     
                  
                  
                     
                        3 months
                     
                  
                  
                     
                        3 weeks
                     
                  
                  
                     
                        3 weeks prior to the date of collection of the eggs from which the day-old chicks have been hatched
                     
                  
               
                     
                        Captive birds
                     
                  
                  
                     
                        AC
                     
                  
                  
                     
                        -
                     
                  
                  
                     
                        3 weeks or since hatching 
                     
                  
                  
                     
                        3 weeks, or since hatching, if the animals are less than 3 weeks of age
                     
                  
               
               AC = Animals of the consignment
            
         
         
            
               FO = Flock of origin
            
            
               ANNEX IV
            
            
               PART A
            
            
               1.Minimum periods in months 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 :
            
            
                     
                  
                  
                     
                        1.Bovine animals
                     
                  
                  
                     
                        2. Ovine animals
                     
                  
                  
                     
                        3. Caprine animals
                     
                  
                  
                     
                        4. Porcine animals
                     
                  
                  
                     
                        5. Camelid animals
                     
                  
                  
                     
                        6. Cervid animals
                     
                  
                  
                     
                        7. Ungulates other than those referred to in columns 1,2,3,4,5,6,*
                     
                  
               
                     
                        Foot and mouth disease
                     
                  
                  
                     
                        24 m**
                     
                  
                  
                     
                        24 m**
                     
                  
                  
                     
                        24 m**
                     
                  
                  
                     
                        24 m**
                     
                  
                  
                     
                        24 m**
                     
                  
                  
                     
                        24 m**
                     
                  
                  
                     
                        24 m**
                     
                  
               
                     
                        Infection with rinderpest virus
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
               
                     
                        Rift Valley fever virus
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
               
                     
                        Contagious bovine pleuropneumonia
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        12 m
                     
                  
               
                     
                        Peste des petits ruminants
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        NA
                     
                  
               
                     
                        Sheep pox and goat pox
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
               
                     
                        Contagious caprine pleuropneumonia
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        12 m
                     
                  
               
                     
                        African swine fever
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
               
                     
                        Classical swine fever
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        12 m**
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        12 m
                     
                  
               
                     
                        Lumpy skin disease
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
               
               *only applicable for listed species in accordance with the Annex to 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
            
            
               2.Minimum periods in months 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 m
                     
                  
               
               3.Minimum periods in months without a case or outbreak of disease 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 m
                     
                  
               
                     
                        Infection with Burkholderia mallei (Glanders)**
                     
                  
                  
                     
                        36 m
                     
                  
               
                     
                        Dourine**
                     
                  
                  
                     
                        24 m
                     
                  
               
                     
                        Surra (Trypanosoma evansi)**
                     
                  
                  
                     
                        24 m
                     
                  
               
            
               ** 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)
            
            
               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):
            
            
                     
                        Foot and mouth disease
                     
                  
                  
                     
                        Supplementary information to determine the date from which the third country or territory or zone thereof is considered to be free from foot and mouth disease.
                     
                  
               
                     
                        Classical swine fever
                     
                  
                  
                     
                        (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; 
                     
                     
                        (b) the animals intended for entry into the Union have reacted negatively to tests for classical swine fever, carried out within a period of 30 days prior to the date of dispatch to the Union.
                     
                  
               
                     
                        Infection with Burkholderia mallei (Glanders)
                     
                  
                  
                     
                        (a) no case or outbreak has been reported in the establishment of origin during a period of at least 6 months prior to the date of dispatch to the Union; 
                     
                     
                        (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. 
                     
                  
               
                     
                        Dourine
                     
                  
                  
                     
                        (a) there has been no case or outbreak of the disease in the establishment of origin for a period at least 6 months prior to the date of dispatch to the Union; 
                     
                     
                        (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.
                     
                  
               
                     
                        Surra (Trypanosoma evansi)
                     
                  
                  
                     
                        (a) there has been no case or outbreak of surra (Trypanosoma evansi) in the establishment of origin for a period of at least the 6 months prior to the date of dispatch to the Union; 
                     
                     
                        (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.
                     
                  
               
               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):
            
            
                     
                  
                  
                     
                        1.Bovine animals
                     
                  
                  
                     
                        2. Ovine animals
                     
                  
                  
                     
                        3. Caprine animals
                     
                  
                  
                     
                        4. Porcine animals
                     
                  
                  
                     
                        5. Camelid animals
                     
                  
                  
                     
                        6. Cervid animals
                     
                  
                  
                     
                        7. Ungulates others than those referred to 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
                     
                  
               
                     
                        Rift Valley fever virus
                     
                  
                  
                     
                        NV/ NVA
                     
                  
                  
                     
                        NV/ NVA
                     
                  
                  
                     
                        NV/ NVA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NV/ NVA
                     
                  
                  
                     
                        NV/ NVA
                     
                  
                  
                     
                        NV/ NVA
                     
                  
               
                     
                        Contagious bovine pleuropneumonia
                     
                  
                  
                     
                        NV/ NVA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NV/ NVA
                     
                  
               
                     
                        Peste des petits ruminants
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NV/ NVA
                     
                  
                  
                     
                        NV/ NVA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NV/ NVA
                     
                  
                  
                     
                        NV/ NVA
                     
                  
                  
                     
                        NA
                     
                  
               
                     
                        Sheep pox and goat pox
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NV/ NVA
                     
                  
                  
                     
                        NV/ NVA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
               
                     
                        Contagious caprine pleuropneumonia
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NV/ NVA
                     
                  
                  
                     
                        NV/ NVA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NV/ NVA
                     
                  
               
                     
                        Classical swine fever
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NV/ NVA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
               
                     
                        Lumpy skin disease
                     
                  
                  
                     
                        NVA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        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, 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 Regulation (EU) 2018/1882 
            
            
               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):
            
            
                     
                        African horse sickness
                     
                  
                  
                     
                        -
                              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 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
                     
                  
               
                     
                        Venezuelan equine encephalomyelitis
                     
                  
                  
                     
                        -
                              The equine animals have not been vaccinated at least in the last 60 days prior to dispatch to the Union 
                     
                  
               
               ANNEX V
            
            
               REQUIREMENTS FOR THE 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 with one of the diagnostic methods provided for in Part 2 of Annex 1 to 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 six 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 with one of the diagnostic methods provided for in Part 1 of Annex I to 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 (B.abortus, B. melitensis and B. suis) without vaccination as regards ovine and caprine animals, they must comply with one of the following requirements: 
            
            
               (a)they have been tested with one of the diagnostic methods provided for in Part 1 of Annex I to 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.
            
            
               ANNEX VI
            
            
               
                     Part ASpecific 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 for infection with bluetongue virus (serotype 1-24) (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 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; 
            
            
               (ii)for a period of at least 28 days prior to the date of dispatch to the Union, and were subjected to a serological test, with negative results, carried out on samples collected at least 28 days following the date of the entry of the animal into the seasonally free from infection with bluetongue virus (serotypes 1-24) free third country or territory or zone thereof; or
            
            
               (iii)for a period of at least 14 days prior to the date of dispatch to the Union, and were subjected to a polymerase chain reaction (PCR) test, with negative results, carried out on samples collected at least 14 days following the date of entry of the animal into the seasonally BTV free third country or territory or zone thereof.
            
            
               (a)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 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 two 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 were subjected to 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.
            
            
               (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 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 the animals were subjected with positive results to a serological test able to detect specific antibodies against all serotypes (1-24) bluetongue virus reported during the preceding two 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 the 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 BSpecific 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 a third country or territory or zone thereof where that disease has not been reported during the period of 24 months prior to the date of loading for dispatch to the Union, and:
            
            
               (a)animals over the age of 24 months have been subjected to a laboratory examination for enzootic bovine leukosis with one of the diagnostic methods provided for in Part 4 of Annex I to 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 on two occasions at an interval of at least four months while kept in isolation from the other bovine animals of the same establishment, during the period of 12 months prior to date of dispatch to the Union; or
            
         
         
            
               (b)animals less than 24 months of age, originate from 'uterine' mothers (dams), which have been subjected to a laboratory examination for enzootic bovine leukosis with one of the diagnostic methods provided for in Part 4 of Annex I to 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 during the period of 12 months prior to the date of dispatch to the Union on two occasions at an interval of not less than four months.
            
            
               ANNEX VII
            
            
               
               ADDITIONAL REQUIREMENTS FOR THE ENTRY INTO THE UNION OF UNGULATES AS REGARDS THE DISEASE OF THE THIRD COUNTRY OR TERRITORY OF ORIGIN OR ZONE THEREOF 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 been subject to quarantine for a period of at least 30 days prior to the date of dispatch to the Union and have been subjected to a serological test for the detection of antibodies against whole BoHV-1 or, in case of DIVA-vaccinated animals, antibodies against BoHV-1-gE, with one of the diagnostic methods provided for in Part 5 of Annex I to 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, 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
            
            
               In case that camelid and cervid animals are 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, they must come from an establishment in which no infectious bovine rhinotracheitis/infectious pustular vulvovaginitis has been reported on cervid animals the last 30 days prior to departure.
            
            
               2.Bovine viral diarrhoea
            
            
               The animals must have been tested for bovine viral diarrhoea virus antigen or genome with one of the diagnostic methods provided for in Part 6 of Annex I to 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 case of pregnant dams, they have been subjected to a serological test for the detection of antibodies against bovine viral diarrhoea virus with one of the diagnostic methods provided for in Part 6 of Annex I, 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 with one of the diagnostic methods provided for in Part 6 of Annex I to Regulation (EU) 2019/… as regards animal health requirements for 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 case of pregnant dams, before insemination preceding the current gestation.
            
            
               3.Infection with Aujeszky disease virus
            
            
               1.The animals must have been subjected to a serological test for the detection of antibodies against all Aujeszky’s disease virus with one of the diagnostic methods provided for in Part 7 of Annex 1 to 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, on a sample collected in the establishment of origin during the period of 15 days prior to the date of their dispatch to the Union. 
            
            
               2.For porcine animals less than 4 months of age descending from DIVA-vaccinated mothers, the serological test for the detection of antibodies against Aujeszky’s disease virus gE protein provided for in Section 6 of Annex Y of Regulation (EU) 2019/… as regards animal health requirements for movements within the Union of terrestrial animals and hatching eggs [document C(2019)4058] may be used instead of the serological test referred to in point 1. 
            
            
               3.The number of porcine animals sampled for the serological tests referred to in points 1 and 2 must allow at least for the detection of 10% seroprevalence of the consignment with a 95% confidence.
            
            
               ANNEX VIII
            
            
               ANIMAL HEALTH REQUIREMENTS AS REGARDS THE ESTABLISHMENT OF ORIGIN OF UNGULATES
            
            
               1.Minimum areas (in radius) and periods (in days) without a reported case or outbreak of certain diseases 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):
            
            
                     
                  
                  
                     
                        1. Bovine animals
                     
                  
                  
                     
                        2. Ovine animals
                     
                  
                  
                     
                        3. Caprine animals
                     
                  
                  
                     
                        4. Porcine animals
                     
                  
                  
                     
                        5. Camelid animals
                     
                  
                  
                     
                        6. Cervid animals
                     
                  
                  
                     
                        7. Ungulates others than those referred to in 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
                     
                  
               
                     
                        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
                     
                  
               
                     
                        Contagious bovine pleuropneumonia
                     
                  
                  
                     
                        10 km /
                     
                     
                        30 days
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        10 km / 30 days
                     
                  
               
                     
                        Peste des petits ruminants
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        10 km /
                     
                     
                        30 days
                     
                  
                  
                     
                        10 km /
                     
                     
                        30 days
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        10 km /
                     
                     
                        30 days
                     
                  
                  
                     
                        10 km / 30 days
                     
                  
                  
                     
                        NA
                     
                  
               
                     
                        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
                     
                  
               
                     
                        Lumpy skin disease
                     
                  
                  
                     
                        10 km /
                     
                     
                        30 days
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
               
                     
                        Infection with epizootic haemorrhagic disease virus
                     
                  
                  
                     
                        150 km/ 
                     
                     
                        2 years**
                     
                  
                  
                     
                        150 km/ 
                     
                     
                        2 years**
                     
                  
                  
                     
                        150 km/ 
                     
                     
                        2 years**
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        150 km/ 
                     
                     
                        2 years**
                     
                  
                  
                     
                        150 km/ 
                     
                     
                        2 years**
                     
                  
                  
                     
                        150 km/ 
                     
                     
                        2 years**
                     
                  
               
         
            
               *only applicable for listed species in accordance with the Annex to 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)
            
            
               2.Minimum periods without a reported case or outbreak of certain diseases in the establishment of origin for ungulates other than equine animals as referred to in Article 23(1)(a)(i):
            
            
                     
                  
                  
                     
                        1. Bovine animals
                     
                  
                  
                     
                        2. Ovine animals
                     
                  
                  
                     
                        3. Caprine animals
                     
                  
                  
                     
                        4. Porcine animals
                     
                  
                  
                     
                        5. Camelid animals
                     
                  
                  
                     
                        6. Cervid animals
                     
                  
                  
                     
                        7. Ungulates others than those referred to in columns 1,2,3,4,5,6*
                     
                  
               
                     
                        Burkholderia mallei (Glanders)
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        6 months
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        Same as equine animals (point 4)
                     
                  
                  
                     
                        NA
                     
                  
               
                     
                        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 disease virus
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        30 days
                     
                  
                  
                     
                        NA
                     
                  
               
               *only applicable for listed species in accordance with the Annex to Regulation (EU) 2018/1882 
            
            
               **if a case or outbreak 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 were subjected with negative result to a test for surra (Trypanosoma evansi) as described in [Part 3 of Annex I to 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.
            
            
                     
                  
                  
                     
                        Area
                     
                  
                  
                     
                        Period
                     
                  
                  
                     
                        Requirements to be complied with where there has been a case or outbreak in the establishment
                     
                  
               
                     
                        Equine infectious anaemia 
                     
                  
                  
                     
                        200 m
                     
                  
                  
                     
                        3 m1
                     
                  
                  
                     
                        All the equine animals were isolated until they were subjected a serological test for equine infectious anaemia carried out with negative results on 2 samples taken after the slaughter of the infected animal and 3 months apart
                     
                  
               
               3.Minimum areas (in radius) and periods (in months) 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):
            
            
               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):
            
            
                     
                  
                  
                     
                        Period
                     
                  
                  
                     
                        Requirements to be complied with where there has been a previous reported case or outbreak in the establishment
                     
                  
               
                     
                        Infection with Burkholderia mallei (Glanders)
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        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: 
                     
                     
                        –the infected animals have been killed and destroyed; and
                     
                     
                        –the remaining animals were subjected to a test carried out as described in point 1 of Annex XI of [document C(2019)4058] 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
                     
                  
               
                     
                        Venezuelan equine encephalomyelitis
                     
                  
                  
                     
                        6m
                     
                  
                  
                     
                        In case 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 encephalomyelitis with the diagnostic method provided 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
                     
                     
                        –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.
                     
                     
                  
               
                     
                        Dourine
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        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
                     
                     
                        –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.
                     
                  
               
                     
                        Surra
                           (Trypanosoma evansi)
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        Where infection was reported in the establishment during the period of 2 years prior to the date of dispatch to the Union, the establishment remained under movement restriction by the competent authority until: 
                     
                     
                        –the infected animals have been removed from the establishment; and 
                     
                     
                        –the remaining animals have been subjected to a test for surra (Trypanosoma evansi) with 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.
                     
                  
               
                     
                        Equine infectious anemia
                     
                  
                  
                     
                        90 d
                     
                  
                  
                     
                        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
                     
                     
                        –the remaining animals in the establishment have been subjected to a test foe 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 d
                     
                  
                  
                     
                        -
                     
                  
               
                     
                        Anthrax
                     
                  
                  
                     
                        15 d
                     
                  
                  
                     
                        -
                     
                  
               
                  
            
            
               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
                     
                  
               
                     
                        Caprine animals
                     
                  
                  
                     
                        Subjected to a surveillance programme to detect infection in accordance with the procedures in [part 1 of Annex II of 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)no infection has been reported in animals of the same species on the establishment during the period of 42 days prior to the date of dispatch to the Union; 
                     
                     
                        (b)no animals which do not fulfil the requirement set out in point (a) have been introduced into the establishment during the period of 12 months prior to the date of dispatch to the Union.
                     
                  
               
                     
                        Camelid animals
                     
                  
                  
                     
                  
               
                     
                        Cervid animals
                     
                  
                  
                     
                  
               
               2.Infection with Brucella B. abortus, B. melitensis and B. suis (as referred to in Article 23(3))
            
            
                     
                        Species
                     
                  
                  
                     
                        Requirements as regards the establishment of origin
                     
                  
               
                     
                        Bovine animals
                     
                  
                  
                     
                        Free without vaccination as regards bovine animals
                     
                  
               
                     
                        Ovine animals
                     
                  
                  
                     
                        Free without vaccination as regards ovine and caprine animals
                     
                  
               
                     
                        Caprine animals
                     
                  
                  
                     
                        Free without vaccination as regards ovine and caprine animals
                     
                  
               
                     
                        Porcine animals
                     
                  
                  
                     
                        Biosecurity and risk mitigating measures are in place to prevent the transmission of infection from wild animals of listed species likely to be infected 
                     
                  
               
                     
                  
                  
                     
                        Subjected to a surveillance programme to detect infection in accordance with the procedures in [Part 1 of Annex I of Regulation (EU) 2019/… document C(2019)4058] and compliance with the following requirements:
                     
                     
                        (a)only animals from establishments in which a surveillance for infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis) has been carried out on the animals kept on the establishment in accordance with [point 1 and 2 of Part 1 of Annex II Regulation (EU) 2019/… document C(2019)4058] for at least the last 12 months prior to departure, can be introduced. During this period only caprine animals from establishments applying the measures provided for in this paragraph can be introduced in the establishments mentioned in this indent. 
                     
                     
                        (b)(ii)
                              in case infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis) has been reported on the establishment, measures were taken in accordance with [part 1(3) of Annex II of Regulation (EU) 2019/… document C(2019)4058].
                     
                  
               
                     
                        Camelid animals
                     
                  
                  
                     
                  
               
                     
                        Cervid animals
                     
                  
                  
                     
                  
               
               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 must comply with the following requirements: 
            
            
               (a)they have remained for a continuous period of at least 60 days in an establishment where no case or outbreak of infection with Brucella ovis (contagious epididymitis) has been reported during the period of 12 months prior to the date of dispatch to the Union; 
            
            
               (b)they have been subjected to a serological test for contagious epididymitis during the period of 30 days prior to the date of dispatch to the Union.
            
            
               2.Porcine animals and ungulates of the family Tayassuidae 
            
            
               Porcine animals and ungulates of the family Tayassuidae must have been subjected during the period of 30 days prior to date of dispatch to the Union to a buffered Brucella antigen test for the detection of Brucella suis with negative results.
            
            
               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 Group
                     
                  
                  
                     
                        Diseases for which specific requirements are required
                     
                  
               
                     
                        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 following points:
            
            
               (a)the animals have been kept in isolation in vector protected premises for a period of at least 40 days prior to the date of dispatch to the Union; 
            
            
               (b)the animals have been kept in isolation in vector protected premises for a period of at least 30 days prior to the date of dispatch to the Union and have been subjected to a serological test, carried out by the same laboratory on the same day on blood samples taken during the isolation period in vector protected premises on two occasions with an interval of between 21 and 30 days, the second of which must have been taken within a period of 10 days prior to the date of dispatch, with negative results in each case or with negative result in an agent identification test on the second sample;
            
            
               (c)the animals have been kept in isolation in vector protected premises for a period of at least 30 days prior to dispatch to the Union and prior to the date of a serological and an agent identification test for African horse sickness, 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 quarantine and within a period of 10 days prior to the date of dispatch; 
            
            
               (d)the animals have been kept in isolation in vector protected premises for a period of at least 14 days prior to dispatch and prior to an agent identification test for African horse sickness, carried out with negative result on a blood sample taken not less than 14 days after the date of introduction into the vector-proof quarantine and not more than 72 hours before the time of dispatch.
            
            
               2.2.Specific requirements for Venezuelan equine encephalomyelitis
            
            
               Equine animals must comply with the set of requirements laid down in one of the following points:
            
            
               (a)the animals:
            
         
         
            
               (i)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;
            
            
               (ii)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;
            
            
               (iii)any equine animal on the same holding 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; 
            
            
               or
            
            
               (b)the animals:
            
            
               (i)have not been vaccinated against Venezuelan equine encephalomyelitis;
            
            
               (ii)have been and was 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;
            
            
               (iii)any equine animal on the same holding 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; 
            
            
               (iv)the animals to be dispatched to the Union 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 and the animals have remained protected from vector insects until dispatch; 
            
            
               or
            
            
               (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 has 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 animal and disinsection of the stable and the means in which it is transported.
            
            
               2.3.Specific requirements for glanders
            
            
               Equine animals must have been subjected to 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) 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 been subjected to 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) 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, and 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
            
            
               Equine animals must have been subjected to 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) 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 been subjected with negative results to an agar gel immunodiffusion test (AGID or Coggins test) or to an ELISA for equine infectious anaemia as described in point 2.1. or 2.2. of Chapter 2.5.6 of the OIE Terrestrial Manual (Version adopted 2013) carried out on a blood sample taken within a period not exceeding 90 days prior to the date of dispatch to the Union.
            
            
               ANNEX XII
            
         
         
            
               UNGULATES INTENDED FOR CONFINED ESTABLISHMENTS
            
            
               PART A: Minimum periods (in months) without a reported case or outbreak of disease in the confined establishment of origin of the ungulates intended for confined establishments in the Union:
            
            
                     
                  
                  
                     
                        1.Bovine animals
                     
                  
                  
                     
                        2. Ovine animals
                     
                  
                  
                     
                        3. Caprine animals
                     
                  
                  
                     
                        4. Porcine animals
                     
                  
                  
                     
                        5. Camelid animals
                     
                  
                  
                     
                        6. Cervid animals
                     
                  
                  
                     
                        7. Ungulates others than those referred to in columns 1,2,3,4,5,6,7*
                     
                  
               
                     
                        Foot and mouth disease
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
               
                     
                        Rift Valley fever virus
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
               
                     
                        Contagious bovine pleuropn.
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        6 m
                     
                  
               
                     
                        Peste des petits ruminants
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        NA
                     
                  
               
                     
                        Sheep pox and goat pox
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
               
                     
                        Contagious caprine pleuropn.
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        6 m
                     
                  
               
                     
                        African swine fever
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
               
                     
                        Classical swine fever
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
               
                     
                        Lumpy skin disease
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
               
                     
                        Burkholderia mallei (Glanders)
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
               
                     
                        Brucella (B. abortus, B. melitensis and B. suis)
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
               
                     
                        Mycobacterium tuberculosis complex (M. bovis, M. caprae, M. tuberculosis)
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
               
                     
                        Rabies
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
               
                     
                        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
                     
                  
               
                     
                        Infection with bluetongue virus (Serotypes 1-24)
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
                  
                     
                        6 m
                     
                  
               
                     
                        Aujeszky's disease virus
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
               
               *only applicable for listed species in accordance with the Annex to Regulation (EU) 2018/1882
            
            
               PART B: Minimum areas (in radius) and periods without a reported case or outbreak of certain diseases in the area around the confined establishment of origin of the ungulates intended for confined establishments in the Union:
            
            
                     
                  
                  
                     
                        1.Bovine animals
                     
                  
                  
                     
                        2. Ovine animals
                     
                  
                  
                     
                        3. Caprine animals
                     
                  
                  
                     
                        4. Porcine animals
                     
                  
                  
                     
                        5. Camelid animals
                     
                  
                  
                     
                        6. Cervid animals
                     
                  
                  
                     
                        7. Ungulates others than those referred to in column 1,2,3,4,5,6,7*
                     
                  
               
                     
                        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
                     
                  
               
                     
                        Rift Valley fever virus
                     
                  
                  
                     
                        150 km / 
                     
                     
                        30 days
                     
                  
                  
                     
                        150 km / 
                     
                     
                        30 days
                     
                  
                  
                     
                        150 km / 
                     
                     
                        30 days
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        150 km / 
                     
                     
                        30 days
                     
                  
                  
                     
                        150 km / 
                     
                     
                        30 days
                     
                  
                  
                     
                        150 km / 
                     
                     
                        30 days
                     
                  
               
                     
                        Contagious bovine pleuropneumonia
                     
                  
                  
                     
                        10 km /
                     
                     
                        30 days
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        10 km /
                     
                     
                        30 days
                     
                  
               
                     
                        Peste des petits ruminants
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        10 km /
                     
                     
                        30 days
                     
                  
                  
                     
                        10 km /
                     
                     
                        30 days
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        10 km /
                     
                     
                        30 days
                     
                  
                  
                     
                        10 km /
                     
                     
                        30 days
                     
                  
                  
                     
                        NA
                     
                  
               
                     
                        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 /
                     
                     
                        12 m
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
               
                     
                        Classical swine fever
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        10 km /
                     
                     
                        12 m
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
               
                     
                        Lumpy skin disease
                     
                  
                  
                     
                        150 km / 
                     
                     
                        30 days
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
               
                     
                        Infection with bluetongue virus (Serotypes 1-24)
                     
                  
                  
                     
                        150 km / 
                     
                     
                        30 days
                     
                  
                  
                     
                        150 km / 
                     
                     
                        30 days
                     
                  
                  
                     
                        150 km / 
                     
                     
                        30 days
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        150 km / 
                     
                     
                        30 days
                     
                  
                  
                     
                        150 km / 
                     
                     
                        30 days
                     
                  
                  
                     
                        150 km / 
                     
                     
                        30 days
                     
                  
               
                     
                        Epizootic haemorrhagic disease
                     
                  
                  
                     
                        150 km / 
                     
                     
                        30 days
                     
                  
                  
                     
                        150 km / 
                     
                     
                        30 days
                     
                  
                  
                     
                        150 km / 
                     
                     
                        30 days
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        150 km / 
                     
                     
                        30 days
                     
                  
                  
                     
                        150 km / 
                     
                     
                        30 days
                     
                  
                  
                     
                        150 km / 
                     
                     
                        30 days
                     
                  
               
                     
                        Aujeszky's disease virus
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        5 km /12 m **
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
               
               *only applicable for listed species in accordance with the Annex to Regulation (EU) 2018
            
            
               **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
            
            
               PART C
            
            
               Minimum periods of disease freedom (in months) 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:
            
            
                     
                  
                  
                     
                        1.Bovine animals
                     
                  
                  
                     
                        2. Ovine animals
                     
                  
                  
                     
                        3. Caprine animals
                     
                  
                  
                     
                        4. Porcine animals
                     
                  
                  
                     
                        5. Camelid animals
                     
                  
                  
                     
                        6. Cervid animals
                     
                  
                  
                     
                        7. Ungulates others than those referred to in columns 1,2,3,4,5,6,7*
                     
                  
               
                     
                        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
                     
                  
               
                     
                        Rift Valley fever virus
                     
                  
                  
                     
                        48 m**
                     
                  
                  
                     
                        48 m**
                     
                  
                  
                     
                        48 m**
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        48 m**
                     
                  
                  
                     
                        48 m**
                     
                  
                  
                     
                        48 m**
                     
                  
               
                     
                        Epizootic haemorrhagic disease
                     
                  
                  
                     
                        24m**
                     
                  
                  
                     
                        24m**
                     
                  
                  
                     
                        24m**
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        24m**
                     
                  
                  
                     
                        24m**
                     
                  
                  
                     
                        24m**
                     
                  
               
                     
                        African swine fever
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        12 m*
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
               
                     
                        Classical swine fever
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        12 m*
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
               
                     
                        Brucella (B. abortus, B. melitensis and B. suis)
                     
                  
                  
                     
                        12 m **
                     
                  
                  
                     
                        12 m **
                     
                  
                  
                     
                        12 m **
                     
                  
                  
                     
                        12 m **
                     
                  
                  
                     
                        12 m **
                     
                  
                  
                     
                        12 m **
                     
                  
                  
                     
                        12 m **
                     
                  
               
                     
                        Infection with bluetongue virus (Serotypes 1-24)
                     
                  
                  
                     
                        24m**
                     
                  
                  
                     
                        24m**
                     
                  
                  
                     
                        24m**
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        24m**
                     
                  
                  
                     
                        24m**
                     
                  
                  
                     
                        24m**
                     
                  
               
               *only applicable for listed species in accordance with the Annex to Regulation (EU) 2018
            
            
               **or supplementary guarantees are provided by the competent authority of the third country or territory according to Part B
            
            
               PART D
            
            
               Supplementary guarantees to be provided by the competent authority of the third country or territory as regards certain listed diseases
            
            
                     
                        Foot and mouth disease
                     
                  
                  
                     
                        (a)the animals have been subjected to a serological test for evidence of foot and mouth disease virus infection carried out in accordance with one of 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, 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 taken: 
                     
                     
                        (I)10 days prior to the date of dispatch to the Union, for species other than African buffalo (Synercus 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 (Synercus caffer).
                     
                  
               
                     
                        Rift Valley fever virus
                     
                  
                  
                     
                        (a)the animals must:
                     
                     
                        (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 clinical signs 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.
                     
                     
                        (b)the animals have been subjected to a virus neutralisation test with negative results for evidence of infection with Rift valley fever virus in accordance with the OIE Terrestrial Manual, taken firstly at the date of commencement of the quarantine period and secondly 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 been subjected to 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, taken during the period of 30 days prior to the date of dispatch to the Union. 
                     
                  
               
                     
                        Classical swine fever
                     
                  
                  
                     
                  
               
                     
                        Brucella (B. abortus, B. melitensis and B. suis)
                     
                  
                  
                     
                        (a)the animals have been subjected to a test as laid down and prescribed for international trade by the OIE Terrestrial Manual, during the period of the 30 days prior to the date of dispatch to the Union, or
                     
                     
                        (b)they are castrated males of any age
                     
                  
               
                     
                        Infection with bluetongue virus (Serotypes 1-24)
                     
                  
                  
                     
                        The animals must comply with the requirements set out in one of the following points:
                        (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 of dispatch to the Union and have been subjected to 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 animals into the confined establishment; 
                     
                     
                        (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 the date of dispatch to the Union and have been subjected to 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 at least 14 days after the introduction into the confined establishment; 
                     
                     
                        (c)
                              they come from a seasonally disease-free area and have been subjected during that disease-free period to 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 out at least 28 days after introduction of the animals into the confined establishment; 
                     
                     
                        (d)
                              they come from a seasonally free area and have been subjected during that period to 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 at least 14 days after the introduction of the animals into the approved confined establishment.
                     
                  
               
                     
                        Infections with epizootic haemorrhagic 
                     
                     
                        Disease virus
                     
                  
                  
                     
                  
               
               PART E
            
            
               Requirements as regards the absence of vaccination for certain diseases for the third country or territory of origin or zone thereof and for the ungulates intended for confined establishments:
            
            
                     
                  
                  
                     
                        1. Bovine animals
                     
                  
                  
                     
                        2. Ovine animals
                     
                  
                  
                     
                        3. Caprine animals
                     
                  
                  
                     
                        4. Porcine animals
                     
                  
                  
                     
                        5. Camelid animals
                     
                  
                  
                     
                        6. Cervid animals
                     
                  
                  
                     
                        7. Ungulates others than those referred to in columns 1,2,3,4,5,6*
                     
                  
               
                     
                        Foot and mouth disease
                     
                  
                  
                     
                        NVA
                     
                  
                  
                     
                        NVA
                     
                  
                  
                     
                        NVA
                     
                  
                  
                     
                        NVA
                     
                  
                  
                     
                        NVA
                     
                  
                  
                     
                        NVA
                     
                  
                  
                     
                        NVA
                     
                  
               
                     
                        Rift Valley fever virus
                     
                  
                  
                     
                        NVA**
                     
                  
                  
                     
                        NVA**
                     
                  
                  
                     
                        NVA**
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NVA**
                     
                  
                  
                     
                        NVA**
                     
                  
                  
                     
                        NVA**
                     
                  
               
                     
                        Classical swine fever
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NVA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
                  
                     
                        NA
                     
                  
               
                     
                        Brucella (B. abortus, B.melitensis and B.suis)
                     
                  
                  
                     
                        NVA**
                     
                  
                  
                     
                        NVA**
                     
                  
                  
                     
                        NVA**
                     
                  
                  
                     
                        NVA**
                     
                  
                  
                     
                        NVA**
                     
                  
                  
                     
                        NVA**
                     
                  
                  
                     
                        NVA**
                     
                  
               
                     
                        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 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
            
            
               PART F
            
            
               Requirements for the vector-protected structure required in confined establishments in third countries 
            
            
               Where required in Part D of this Annex, the vector-protected structure in the confined establishments in third countries or territories must comply with the following requirements:
            
            
               (a)have appropriate physical barriers at entry and exit points;
            
            
               (b)the openings of the vector-protected structure 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 structure;
            
            
               (d)measures must be taken to limit or eliminate breeding sites for vectors in the vicinity of the vector-protected structure; 
            
            
               (e)standard operating procedures must be in place, including descriptions of back-up and alarm systems, for the operation of the vector-protected structure and for the transport of the animals from that structure to the place of loading for dispatch to the Union.
            
            
               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 on the introduction of 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 other captive birds.
            
            
               (5)Geographical area where vaccination is carried out.
            
            
               (6)Number of establishments in vaccination area.
            
            
               (7)Number of establishments where vaccination is carried out, if different from number in point 6.
            
            
               (8)Species and categories of poultry or 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 the movements of vaccinated poultry and poultry products derived from vaccinated poultry or vaccinated captive birds.
            
            
               (15)Clinical and laboratory tests carried out in the establishments vaccinated or located in the vaccination area, such as efficacy and pre-movement testing.
            
            
               (16)Means of record keeping. 
            
            
               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 avian influenza is carried out must be required to undergo laboratory testing and the following information, in addition to the information referred to in Annex 2, shall be submitted to the Commission:
            
            
               (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 epidemiological unit 
            
         
         
            
               (4)Number of samples taken per establishment and/or epidemiological unit
            
            
               (5)Data on vaccine efficacy.
            
            
               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)during the period referred to in point (a), they must have been kept in complete isolation 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 six 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 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 six months immediately prior to the date of dispatch of the consignment for entry to the Union;
            
            
               (d)which during the period of 30 days prior to the date of and during the laying of the hatching eggs intended for entry into the Union or from which the day-old chicks destined for entry into the Union are derived, were not in contact with poultry which do not fulfil the guarantees under points (a), (b) and (c).
            
            
               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 were kept for a period of at least three months prior to the date of slaughter on establishments:
            
            
               (i)on which there was no outbreak of infection with Newcastle disease virus or highly pathogenic avian influenza during the period of six months prior to the date of slaughter; 
            
            
               (ii)around which no outbreaks of highly pathogenic avian influenza or infection with Newcastle disease virus occurred for a period of at least three months prior to the date of slaughter, with a distance of 10 kilometres from the perimeter of that part of the establishment which contains 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 six months prior to the date of slaughter .
            
         
         
            
               (c)surveillance as referred to in point (b)(iii) must have been carried out:
            
            
               (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 they were vaccinated against infection with Newcastle disease virus, they were not vaccinated with vaccines that did not meet the specific criteria set out in Part 1 of Annex 15 in 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 the period of 7 to 10 days after the date of the entry of the ratites in 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 was found and favourable results must have been available from all birds in the consignment before:
            
            
               (a)breeding ratites, productive ratites or ratites intended for slaughter have left the facilities referred in 1(b) for dispatch to the Union;
            
            
               (b)day-old chicks have left the hatchery for dispatch to the Union;
            
            
               (c)hatching eggs have been loaded for dispatch to the Union.
            
            
               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, as far 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 absence of undesired contaminating agents, and on efficacy on behalf 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 intracerebral pathogenicity index (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 Part 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 of Part 1, must meet the following requirements: 
            
            
               (a)poultry and the flocks of hatching eggs must not have been vaccinated with such vaccines for a period of at least 12 months prior to the date of loading of the consignment for dispatch to the Union; 
            
            
               (b)the flocks of origin of poultry and hatching eggs must have undergone a virus isolation test for infection with Newcastle disease virus not earlier than two 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 two weeks prior to the date of collection of the eggs: 
            
            
               (i)carried out in an official laboratory; 
            
            
               (ii)on a random sample of cloacal swabs taken from at least 60 birds in each flock; 
            
            
               (iii) in which no avian paramyxoviruses with an Intracerebral Pathogenicity Index of more than 0.4 have been found. 
            
            
               (c)poultry 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 of loading of the consignment for dispatch to the Union; 
            
            
               (ii)in the case of hatching eggs, during the period of 60 days prior to the date of collection of the eggs. 
            
            
               (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 Part 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 of Part 1, 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 Intracerebral Pathogenicity Index (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).
            
         
         
            
               4.Information to be provided when flocks of poultry and hatching eggs are vaccinated against infection with Newcastle disease virus
            
            
               Where flocks of poultry and hatching eggs are vaccinated against infection with Newcastle disease virus, the following information shall 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 vaccine;
            
            
               (f)name of vaccine;
            
            
               (g)manufacturer of vaccine.
            
            
               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 shall 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;
            
            
               (a)the number of animals;
            
            
               (b)the category and type of production for which they are intended;
            
            
               (c)the name, address and approval number of the establishment of origin;
            
            
               (d)the name of the Member State of destination.
            
            
               2.Poultry intended for slaughter shall 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 shall be transported in containers which shall 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 shall 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 shall be transported in containers which bear the following indications:
            
         
         
            
               (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 shall 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 shall 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.
            
         
         
            
               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 THE 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 111 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 or 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 the 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.
            
            
               ANNEX XVIII
            
            
               SAMPLING AND TESTING OF POULTRY OTHER THAN RATITES AFTER THE ENTRY INTO THE UNION
            
            
               1.The official veterinarian shall take samples from breeding poultry other than ratites, productive poultry other than ratites and day-old chicks thereof which have entered into the Union from a third country or territory or zone thereof, for virological examination as follows: 
            
            
               (a)Between the seventh and the fifteenth day following the date when they were placed on 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, subject to a maximum of five samples from individual birds in each pool.
            
            
               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 57, shall be the following:
            
            
               (a)only animals coming from other approved establishments are introduced into the establishment;
            
            
               (b)were birds are introduced into the establishment from sources other than approved establishments, they may be introduced into the establishment after approval for such an introduction is given by the competent authority of the third country or territory, provided that such animals are isolated for a period of 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 on the establishment. 
            
            
               2.The animal health requirements in relation to the facilities and equipment on the establishment, as referred to in Article 57, shall be the following:
            
         
         
            
               (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 of the establishment in relation to record keeping, as referred to in Article 57, shall be the following:
            
            
               (a)it 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. 
            
            
               (b)the establishment shall 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 on the establishment, as referred to in Article 57, shall be the following:
            
            
               (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)shall ensure 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 plan 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 World Organisation for Animal Health (OIE); 
            
            
               (ii)shall ensure that any suspect deaths or the presence of any other symptoms suggesting that animals have contracted 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)shall ensure that animals entering the establishment have been isolated as necessary, and in accordance with the requirements of Articles … and the instructions, if any, given by the competent authority of the third country or territory;
            
            
               (iv)shall be responsible for the day to day compliance with the animal health requirements laid down in Article ...
            
            
               5.The animal health requirements of the establishment in relation to health status, as referred to in Article 57, shall be the following:
            
            
               (a)it 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 shall only be approved on the results of the clinical and laboratory tests carried out on the animals in such establishments; 
            
            
               (b)it 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.
            
            
               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 be subjected to the following procedures: 
            
            
               (a)with the use of sentinel birds: 
            
            
               (i)blood samples for serological examination must be taken from all sentinel birds within a period of not less then 21 days following the date of their entry into the quarantine and within a period of at least three 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 be subjected to 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)without the use of sentinel birds:
            
            
               –imported birds must be examined virologically (namely, serological testing not being 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 shall 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 the death from either: 
            
            
               (i)dead sentinel birds and all birds dead on arrival in the quarantine and those which die during quarantine; 
                  or 
            
         
         
            
               (ii)in the case of high mortality in small birds of large consignments, from at least 10 % of the dead birds. 
            
            
               3.For virological examination, pooling of samples up to a maximum of five samples of individual birds in one pool shall be allowed. 
            
            
               Faecal material must be pooled separately from other organ and tissue samples.
            
            
               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 vaccination 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 on 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 previous vaccination referred to in point (a).
            
            
               2.TREATMENT AGAINST INFESTATION WITH ECHINOCCOCUS MULTILOCULARIS
            
            
               Prior to the entry into the Union, dogs shall be treated against infestation with Echinococcus multilocularis, as follows:
            
            
               (a)the treatment must consist of an approved 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 treatment must be administered by a veterinarian within a period commencing not more than 120 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 document referred to in Article 76(1)(a)(iv):
            
            
               (i)transponder or tattoo alphanumeric code of the dog, cat or ferret;
            
            
               (ii)name of the product and manufacturer of the treatment against infestation with Echinococcus multilocularis;
            
            
               (iii)date and time of treatment;
            
            
               (iii)name, stamp and signature of the administering veterinarian.
            
            
               ANNEX XXII
            
         
         
            
               REQUIREMENTS AS REGARDS THE RESIDENCY PERIODS OF HATCHING EGGS BEFORE THE ENTRY INTO THE UNION
            
            
                     
                        Category of hatching eggs
                     
                  
                  
                     
                        Minimum residency period applies to
                     
                  
                  
                     
                        Minimum residency period in the third country or territory of origin or zone thereof, as referred in Article 98(a)
                     
                  
                  
                     
                        Minimum residency period in the establishment of origin, as referred to in Article 98(b)
                     
                  
                  
                     
                        Minimum period without contact with poultry or hatching eggs of lower health status, captive birds or wild birds as referred to in Article 98(c)
                     
                  
               
                     
                        Hatching eggs of poultry
                     
                  
                  
                     
                        Flock of origin
                     
                  
                  
                     
                        3 months
                     
                  
                  
                     
                        6 weeks
                     
                  
                  
                     
                        6 weeks
                     
                  
               
                     
                        Consignments of Less than 20 hatching eggs of poultry other than ratites
                     
                  
                  
                     
                        Flock of origin
                     
                  
                  
                     
                        3 months
                     
                  
                  
                     
                     
                        3 weeks
                     
                     
                  
                  
                     
                        3 week
                     
                  
               
               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), shall be either:
            
            
               (a)at least three months prior that date; or
            
            
               (b)less than three months prior to that date, if the ungulates are less than three months of age.
            
            
               2.The period for which the 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), shall be a period of at least 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 24;
            
            
               (b)are covered by derogation provided for in Article 132.
            
            
               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 131(1).
            
            
                     
                  
                  
                     
                        1. Bovine animals
                     
                  
                  
                     
                        2. Ovine animals
                     
                  
                  
                     
                        3. Caprine animals
                     
                  
                  
                     
                        4. Porcine animals
                     
                  
                  
                     
                        5. Camelid animals
                     
                  
                  
                     
                        6. Cervid animals
                     
                  
                  
                     
                        7. Ungulates other than those referred 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
                     
                  
               
                     
                        Rift Valley fever virus
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
               
                     
                        Peste des petits ruminants
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
                  
                     
                        12 m
                     
                  
               
                     
                        Sheep pox and goat pox
                     
                  
                  
                     
                        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 Regulation (EU) 1882/2018
            
            
               **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 
            
            
               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 131(2):
            
            
                     
                        Foot and mouth disease
                     
                  
                  
                     
                        Supplementary information to guarantee the determination of a date from which the third country or territory or zone thereof shall be considered to be free from the disease
                     
                  
               
                     
                        Classical swine fever
                     
                  
                  
                     
                  
               
         
            
               ANNEX XXV
            
            
               VACCINATION IN THE THIRD COUNTRY OR TERRITORY OF ORIGIN OR ZONE THEREOF AND IN THE ANIMALS OF ORIGIN AND OF THE PRODUCTS OF ANIMAL ORIGIN
            
            
               Part A
            
            
               Animal health Requirements as regards the absence of vaccination in the third country or territory of origin or zone thereof and for the establishment of origin of the ungulates from which the fresh meat is obtained:
            
            
                     
                  
                  
                     
                        1. Bovine animals
                     
                  
                  
                     
                        2. Ovine animals
                     
                  
                  
                     
                        3. Caprine animals
                     
                  
                  
                     
                        4. Porcine animals
                     
                  
                  
                     
                        5. Camelid animals
                     
                  
                  
                     
                        6. Cervid animals
                     
                  
                  
                     
                        7. Ungulates other than those referred to in 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**
                     
                  
               
                     
                        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 Regulation (EU) 2018/1882 
            
            
               **or specific conditions, in accordance with Part B, are provided by the competent authority of the third country or territory 
            
            
               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 131(4).
            
            
               1.From a third country, territory or zone thereof which is free from foot and mouth disease and where vaccination for foot and mouth disease strains A, O or C is practised 
            
            
               The competent authorities of the third country or territory of origin has provided 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 and controlled by the competent authority of the third country or territory of origin;
            
            
               (b)either:
            
            
               (i)in case of bovine, ovine and caprine animals, which originate from establishments, in and around which, in an area with a 25 kilometres radius, there has been no reported case or outbreak of foot and mouth disease or rinderpest during the period of 60 days prior to the date of dispatch to the Union;
            
            
               (ii)in case of kept ungulates other than bovine, ovine and caprine, porcine and equine animals, originate from establishments in and around which in an area of 50 kilometres radius, there has been no reported case or outbreak of foot and mouth disease or rinderpest, during the period of 90 days prior to the date of dispatch to the Union;
            
            
               (c)the meat is fresh meat other than offal, is de-boned meat and obtained from carcasses:
            
            
               (i)in which the main accessible lymphatic glands 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 for foot-and-mouth disease strains A, O or C is practised
            
            
               In addition to the requirements set out in point 1 the competent authority of the third country or territory has provided additional guarantees for conditions which are specific for the third country, territory or zone thereof and which support the absence of foot and mouth disease virus in the 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
            
            
               The competent authorities of a third country or territory of origin shall provide the necessary supplementary information to guarantee the absence of the foot and mouth disease virus in the fresh meat and compliance with the following animal health requirements; where the fresh meat originates from a foot and mouth freedom zone where vaccination is not practised, but which is in a third country or territory in which vaccination for FMD strains SAT or ASIA 1 is practiced 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:
            
            
               (a)the animals originate from establishments in and around which, in an area with a 10 kilometres radius, there has been no case or outbreak of foot and mouth disease [or rinderpest] during the period of 12 months prior to the date of…;
            
            
               (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 fresh meat other than offal, is de-boned meat and obtained from carcasses:
            
            
               (i)in which the main accessible lymphatic glands 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
            
            
               The competent authorities of the third country or territory of origin shall provide the following supplementary information, where the fresh meat originates in a foot and mouth disease-free zone where vaccination against foot and mouth disease is not practised, but which is in a third country or territory in which vaccination against foot and mouth disease strains A, O or C is practised, and the competent authorities of the third country or territory have provided additional guarantees on conditions which are 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: 
            
            
               (a)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 Part 1; 
            
            
               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 deboned 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 center temperature of at least 65°C is reached for a period of time as necessary to achieve a pasteurization 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.
            
            
               ANNEX XXVII
            
            
               RISK MITIGATING TREATMENTS FOR MILK AND DAIRY PRODUCTS 
            
            
                     
                  
                  
                     
                        A
                     
                  
                  
                     
                        B
                     
                  
               
                     
                        Species of origin of the milk and the dairy products
                     
                  
                  
                     
                        Bos Taurus, Ovis aries, Capra hircus, Bubalus bubalis and Camelus dromedarius
                     
                  
                  
                     
                        Other than Bos Taurus, Ovis aries, Capra hircus, Bubalus bubalis and Camelus dromedarius
                     
                  
               
                     
                        Animal health status of the third country
                     
                  
                  
                     
                        1.
                              Third countries not officially free of foot and mouth (FMD) for the preceding 12 months
                     
                     
                        2.
                              Third countries where vaccination against FMD is practiced
                     
                  
                  
                     
                        Any
                     
                  
               
                     
                        Sterilization process, to achieve an Fo value equal to or greater than 3
                     
                  
                  
                     
                        Yes
                     
                  
                  
                     
                        Yes
                     
                  
               
                     
                        Ultra-high temperature (UHT) treatment at not less than 135°C in combination with a suitable holding time
                     
                  
                  
                     
                        Yes
                     
                  
                  
                     
                        Yes
                     
                  
               
                     
                        High temperature short time pasteurization 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 negative reaction to a alkaline phosphatase test, applied immediately after the heat treatment
                     
                  
                  
                     
                        Yes
                     
                  
                  
                     
                        No
                     
                  
               
                     
                        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
                     
                     
                        (ii)
                              additional heating equal to or greater than 72 °C, combined with desiccation
                     
                  
                  
                     
                        Yes
                     
                  
                  
                     
                        No
                     
                  
               
               No: treatment not permitted
            
            
               Yes: required treatment
            
            
               ANNEX XXVIII
            
            
               RISK MITIGATION TREATMENTS FOR EGG PRODUCTS
            
            
               1.Treatments of egg products for the inactivation of highly pathogenic avian influenza viruses
            
            
               (c)Liquid egg white, either with 55,6oC for 870 seconds or with 56,7oC for 232 seconds.
            
            
               (d)10% salted yolk, with 62,2oC for 138 seconds.
            
            
               (e)Dried egg white, either with 67oC for 20 hours or with 54,4oC for 513 hours.
            
            
               (f)Whole eggs, either at least with 60oC for 188 seconds, or completely cooked.
            
            
               (g)Whole egg blends, either at least with 60oC for 188 seconds, at least with 61,1oC for 94 seconds, or completely cooked.
            
            
               2.Treatments of egg products for the inactivation of infection with Newcastle disease virus
            
         
         
            
               (a)Liquid egg white, either with 55oC for 2278 seconds, with 57oC for 986 seconds, or with 59oC for 301 seconds.
            
            
               (b)10% salted yolk, with 55oC for 176 seconds.
            
            
               (c)Dried egg white, with 57oC for 50,4 hours.
            
            
               (d)Whole eggs, either at least with 55oC for 2 521 seconds, with 57oC for 1 596 seconds, with 59oC for 674 seconds, or completely cooked.
            
            
               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), and tench (Tinca tinca), Orfe (Leuciscus idus)
                     
                  
               
                     
                        Bacterial kidney disease (BKD)
                     
                  
                  
                     
                        Family: Salmonidae
                     
                  
               
                     
                        Infectious pancreatic necrosis (IPN)
                     
                  
                  
                     
                        Rainbow trout (Oncorhynchus mykiss), brook trout (Salvelinus fontinalis), brown trout (Salmo trutta), Atlantic salmon (Salmo salar) and (Oncorhynchus spp.), whitefish (Coregonus lavaretus)
                     
                  
               
                     
                        Infection with Salmonid alphavirus (SAV)
                     
                  
                  
                     
                        Atlantic salmon (Salmo salar), rainbow trout (Oncorhynchus mykiss), brown trout (Salmo trutta)
                     
                  
               
                     
                        Infections 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) and brown trout (Salmo trutta)
                     
                     
                     
                        Any species which have been in contact with a susceptible species are also considered susceptible
                     
                  
               
                     
                        Ostreid herpervirus 1 µvar (OsHV-1 µVar)
                     
                  
                  
                     
                        Pacific oyster (Crassostrea gigas)
                     
                  
               
               ANNEX XXX
            
            
               CONDITIONS UNDER WHICH SPECIES LISTED IN COLUMN 4 OF COMMISSION IMPLEMENTING REGULATION (EU) 2018/1882 ARE REGARDED AS VECTORS
            
            
                     
                        List of diseases
                     
                  
                  
                     
                        Vectors
                     
                  
                  
                     
                        Conditions under which species of aquatic animals listed in column 4 of the Annex of Commission Implementing Regulation (EU) 2018/1882 are regarded as vectors 
                     
                  
               
                     
                        Epizootic haematopoietic necrosis (EHN)
                     
                  
                  
                     
                        As listed in the fourth column of the Annex of Commission Implementing Regulation (EU) 2018/1882 
                     
                  
                  
                     
                        Regarded as vectors of EHN under all conditions.
                     
                  
               
                     
                        Viral haemorrhagic septicaemia (VHS)
                     
                  
                  
                     
                  
                  
                     
                        Regarded as vectors of VHS when in contact with species listed in column 3 of the Annex of Commission Implementing Regulation (EU) 2018/1882 through co-habitation or through water supply. 
                     
                  
               
                     
                        Infectious haematopoietic necrosis (IHN)
                     
                  
                  
                     
                  
                  
                     
                        Regarded as vectors of IHN when in contact with species listed in column 3 of the Annex of Commission Implementing Regulation (EU) 2018/1882 through co-habitation or through water supply. 
                     
                  
               
                     
                        Infection with highly polymorphic region (HPR) deleted infectious salmon anaemia virus (HPR-deleted ISAV)
                     
                  
                  
                     
                  
                  
                     
                        No vector species listed for HPR-deleted ISAV.
                     
                  
               
                     
                        Infection with Mikrocytos mackini
                     
                  
                  
                     
                  
                  
                     
                        No vector species listed for Mikrocytos mackini.
                     
                  
               
                     
                        Infection with Perkinsus marinus
                     
                  
                  
                     
                  
                  
                     
                        Regarded as vectors of Perkinsus marinus when in contact with species listed in column 3 of the Annex of Commission Implementing Regulation (EU) 2018/1882 through co-habitation or through water supply. 
                     
                  
               
                     
                        Infection with Bonamia ostreae
                     
                  
                  
                     
                  
                  
                     
                        Regarded as vectors of Bonamia ostreae when in contact with species listed in column 3 of the Annex of Commission Implementing Regulation (EU) 2018/1882 through co-habitation or through water supply. 
                     
                  
               
                     
                        Infection with Bonamia exitiosa
                     
                  
                  
                     
                  
                  
                     
                        Regarded as vectors of Bonamia exitiosa when in contact with species listed in column 3 of the Annex of Commission Implementing Regulation (EU) 2018/1882 through co-habitation or through water supply. 
                     
                  
               
                     
                        Infection with Marteilia refringens
                     
                  
                  
                     
                  
                  
                     
                        Regarded as vectors of Marteilia refringens when in contact with species listed in column 3 of the Annex of Commission Implementing Regulation (EU) 2018/1882 through co-habitation or through water supply. 
                     
                  
               
                     
                        Infection with Taura syndrome virus
                     
                  
                  
                     
                  
                  
                     
                        Regarded as vectors of Taura syndrome virus when in contact with species listed in column 3 of the Annex of Commission Implementing Regulation (EU) 2018/1882 through co-habitation or through water supply. 
                     
                  
               
                     
                        Infection with yellow head virus
                     
                  
                  
                     
                  
                  
                     
                        Regarded as vectors of Taura syndrome virus when in contact with species listed in column 3 of the Annex of Commission Implementing Regulation (EU) 2018/1882 through co-habitation or through water supply. 
                     
                  
               
                     
                        Infection with white spot syndrome virus
                     
                  
                  
                     
                  
                  
                     
                        Regarded as vectors of Taura syndrome virus when in contact with species listed in column 3 of the Annex of Commission Implementing Regulation (EU) 2018/1882 through co-habitation or through water supply.