Commission Delegated Regulation (EU) 2019/2035 of 28 June 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for establishments keeping terrestrial animals and hatcheries, and the traceability of certain kept terrestrial animals and hatching eggs (Text with EEA relevance)
Date: 2019-06-28
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal disease, disease prevention, epidemic, health risk, live animal, protection of animal life, traceability, transport of animals, veterinary inspection




L_2019314EN.01011501.xml










5.12.2019   


EN


Official Journal of the European Union


L 314/115








            COMMISSION DELEGATED REGULATION (EU) 2019/2035
of 28 June 2019
         
supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for establishments keeping terrestrial animals and hatcheries, and the traceability of certain kept terrestrial animals and hatching eggs
(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’) (1), and in particular Articles 3(5), 87(3), 94(3), 97(2), 101(3), 106(1), 118(1) and (2), 119(1) and 122(2), Articles 271(2) and 279(2) thereof,

Whereas:







(1)


Regulation (EU) 2016/429 lays down rules for the prevention and control of diseases which are transmissible to animals or humans, including, inter alia, rules for establishments keeping terrestrial animals and hatcheries, and for the traceability of certain kept terrestrial animals and hatching eggs within the Union. Regulation (EU) 2016/429 also empowers the Commission to adopt rules to supplement certain non-essential elements of that Regulation by means of delegated acts. It is therefore appropriate to adopt such supplementing rules in order to ensure the smooth functioning of the system in the new legal framework established by Regulation (EU) 2016/429.












(2)


More particularly, this Regulation should lay down rules supplementing those laid down in Chapter 1 and 2 of Title I of Part IV of Regulation (EU) 2016/429 as regards the registration obligation of transporters engaged in the transport of certain kept terrestrial animals other than ungulates, the approval of establishments keeping terrestrial animals posing a significant animal health risk and hatcheries, the registers of transporters and establishments of kept terrestrial animals and hatching eggs to be kept by competent authorities, the record keeping obligations of operators, and the traceability requirements for kept terrestrial animals and hatching eggs. In addition, Regulation (EU) 2016/429 empowers the Commission to lay down rules to ensure that Part IV thereof, is correctly applied to movements of pet animals, other than non-commercial movements. Therefore, this Regulation should also lay down rules regarding such movements.












(3)


‘Hatching eggs’ fall within the definition of ‘germinal products’ set out in point 28 of Article 4 of Regulation (EU) 2016/429, and accordingly are subject to the rules laid down in that Regulation for germinal products. At the same time, the animal health requirements laid down in this Regulation for poultry and captive birds should also apply to hatching eggs of those birds and therefore hatching eggs and the establishments supplying them should be included in the scope of this Regulation.












(4)


While the supplementing rules laid down in this Regulation should be applied to all kept terrestrial animals, there are certain horse populations kept under wild or semi-wild conditions in defined areas in the Union that do not entirely depend on human control for their survival and reproduction, and therefore the traceability requirements laid down in this Regulation cannot be fully applied to those animals. This Regulation should therefore clarify that while the animal health rules laid down in the framework of Regulation (EU) 2016/429 generally apply to these animals of domestic equine species, certain specific derogations are required as it is not possible for the identification requirements of kept terrestrial animals to be applied to horses that are living outside of human control.












(5)


In addition, the rules laid down in this Regulation should supplement the rules laid down in Part IX of Regulation (EU) 2016/429, as regards the transitional measures to protect the acquired rights and legitimate expectations of stakeholders resulting from pre-existing Union acts.












(6)


The rules laid down in this Regulation are substantively linked and apply to operators transporting or keeping terrestrial animals or hatching eggs. Therefore, in the interest of coherency, simplicity and for their effective application, and to avoid a duplication of rules, they should be laid down in a single act rather than dispersed in a number of separate acts containing many cross-references. This approach is also consistent with the one of principle objectives of Regulation (EU) 2016/429, which was to streamline Union animal health rules and thus make them more transparent and easier to apply.












(7)


Article 87(3) of Regulation (EU) 2016/429 empowers the Commission to specify the types of transporters other than those engaged in the transportation of kept ungulates between Member States or between a Member State and a third country, whose transport activity poses specific and significant risks for certain species of animals, and to lay down the information requirements that those transporters must comply with in order to be registered in accordance with Article 93 of Regulation (EU) 2016/429. Therefore, in order to allow the competent authority to efficiently carry out surveillance and prevent, control and eradicate transmissible animal diseases, it is appropriate to establish in this Regulation a list of the other types of transporters and to lay down rules for the information to be provided by them for registration purposes with the competent authority.












(8)


Article 94(1)(a) of Regulation (EU) 2016/429 provides that kept ungulates may only be moved to another Member State if those animals were assembled on establishments approved by the competent authority in accordance with that Regulation. Article 94(3)(a) of Regulation (EU) 2016/429 empowers the Commission to adopt delegated acts providing for derogations from the requirement to apply to the competent authority for approval for certain types of establishments, where those establishments pose an insignificant risk.












(9)


Given the specific situation of equine animals which are not always primarily kept for food producing purposes, but often for recreational and sporting purposes, and in most cases those animals are simply gathered on an establishment, in order to be moved to another Member State, for purposes such as participation in exhibitions, sporting, cultural or similar events, it is appropriate to provide for a derogation in this Regulation from the requirements for operators of those establishments to apply to the competent authority for approval as those establishments pose an insignificant animal health risk and no residency period is applicable in case of the listed diseases for equine animals.












(10)


Article 94(1)(c) of Regulation (EU) 2016/429 provides that hatching eggs may only be moved to another Member State if those eggs come from an establishment approved by the competent authority in accordance with that Regulation. Hatching eggs of poultry or other captive birds fall within the definition of hatching eggs laid down in Article 4 of Regulation (EU) 2016/429, and accordingly operators of establishments producing those eggs which are to be moved to another Member State are required to apply to the competent authority for approval of their establishment.












(11)


However, hatcheries of captive birds do not pose the same health risk for the spread of listed diseases as hatcheries of poultry. The importance and volume of production of hatchlings and hatching eggs of captive birds is much smaller than that of poultry for agricultural production. In addition, the commercial trade circuits of poultry production and captive birds, and in particular those of hatching eggs, are distinct from one another and have limited contact. Therefore, the risk for the spread of listed diseases to poultry via the movements of hatchlings and hatching eggs of captive birds is limited. Accordingly, this Regulation should provide for a derogation from the requirements to apply to the competent authority for approval for operators of hatcheries of captive birds.












(12)


Article 94(1) of Regulation (EU) 2016/429 provides that kept ungulates, poultry and hatching eggs may only be moved to another Member State if those animals or hatching eggs were assembled on or originating from establishments approved by the competent authority in accordance with that Regulation. In addition, Article 95 of Regulation (EU) 2016/429 provides that terrestrial animals kept on an establishment with a confined status may only be moved to or from their establishment if it has obtained an approval of that status from the competent authority in accordance with that Regulation. The competent authority may only approve those establishments if they comply with certain requirements, in relation to quarantine, isolation and other biosecurity measures, surveillance, facilities and equipment, personnel and veterinarians, as well as supervision by the competent authority. Article 97(2) of that Regulation provides for the Commission to adopt delegated acts laying down supplementing rules for the approval of establishments taking into account those requirements.












(13)


The requirements laid down in this Regulation for the approval of those establishments should take into account the experience gained in the application of the rules laid down in Council Directives 64/432/EEC (2), 92/65/EEC (3) and 2009/158/EC (4). Those Directives are repealed by Regulation (EU) 2016/429 as from 21 April 2021.












(14)


Article 94(3)(b) of Regulation (EU) 2016/429 provides for the Commission to adopt delegated acts establishing which other types of establishments for kept terrestrial animals are also required to be approved by the competent authority in accordance with Article 94(1) of that Regulation. An increasing number of dogs, cats and ferrets originating from different establishments or former stray, feral, lost, abandoned or confiscated dogs, cats and ferrets are assembled on establishments for the purpose of grouping them into a consignment before they are moved to another Member State. Directive 92/65/EEC already lays down animal health requirements applicable to the movement of those animals to another Member State. However, in order to carry out adequate surveillance and to apply preventive health measures based on compliance with certain requirements with respect to the animal health status of the Member State, this Regulation should provide for those establishments to apply to the competent authority for approval and also lay down requirements for granting such approval.












(15)


Council Regulation (EC) No 1255/97 (5) lays down animal health requirements to be complied with by operators of control posts applying to the competent authority for approval. Those requirements should be maintained, but updated in this Regulation as they have proven to be effective in preventing the spread of animal diseases within the Union.












(16)


In most cases, bumble bees are bred in environmentally isolated establishments subject to high-level biosecurity measures and subject to regular controls by the competent authority and checked for the presence of diseases. When those establishments are recognised by and supervised by the competent authority, they are unlikely to be affected by the presence of small hive beetle, in contrast with open air colonies. This Regulation should therefore provide for such establishments to be approved and supervised by the competent authority and lay down requirements for granting such approval.












(17)


Commission Implementing Regulation (EU) No 139/2013 (6) lays down the animal health conditions for imports of certain birds into the Union and the quarantine conditions for such imports. In particular it lays down conditions for the approval by the competent authority of the quarantine facilities and centres for such birds. In order to avoid a multiplication of rules for quarantine establishments for different species of terrestrial animals, this Regulation should maintain the main substance of those requirements, but adapt them so that they can be applied to multiple species of terrestrial animals.












(18)


Regulation (EC) No 1069/2009 of the European Parliament and of the Council (7) lays down public health and animal health rules for animal by-products and derived products, in order to prevent and minimise risks to public and animal health arising from those products, and in particular to protect the safety of the food and feed chain. In particular, it lays down the rules on the collection, transport, storage, handling, processing and use or disposal of animal by-products, including animals killed to eradicate epizootic diseases, to prevent them from presenting a risk to animal and public health. Regulation (EC) No 1069/2009 together with a number of implementing measures adopted pursuant to that Regulation, provide a general framework for the disposal of dead animals. When approving establishments in accordance with Articles 97 and 99 of Regulation (EU) 2016/429, the competent authority should ensure that applicants comply with rules laid down within the framework of Regulation (EC) No 1069/2009.












(19)


Article 101(1) of Regulation (EU) 2016/429 provides that the competent authorities are to establish and keep up-to-date registers of establishments and operators registered and approved by them, and that those registers are to be made available to the Commission and to the competent authorities of other Member States. In the interests of transparency, those registers should also be made publically available.












(20)


In addition, Article 101(3) of Regulation (EU) 2016/429 provides for the Commission to adopt delegated acts laying down the detailed information to be included in the registers kept by the competent authority and the public availability of the registers of the approved establishments. Therefore, this Regulation should set out the information obligations of the competent authority as regards those registers.












(21)


Articles 102 to 105 of Regulation (EU) 2016/429 lay down requirements concerning the minimum information to be recorded by operators of establishments and transporters registered or approved by the competent authority, and Article 106 thereof provides for the Commission to lay down rules supplementing those record-keeping obligations. Operators of establishments and transporters have first-hand knowledge of kept terrestrial animals under their care, and when animals are to be moved, they are obliged to provide certain information to the competent authority for the purposes of animal health certification or of their traceability, and consequently that information is easily accessible to the competent authority. Therefore, this Regulation should lay down rules on the information to be recorded by certain operators of establishments and transporters in addition to that already required under Regulation (EU) 2016/429.












(22)


Articles 112 to 115 of Regulation (EU) 2016/429 require operators keeping bovine, ovine, caprine, porcine and equine animals to identify each animal by a physical means of identification, and to ensure that those animals are accompanied by an identification or movement document when they are moved and to transmit information, as required into a computer database kept by the competent authority. In addition, Article 117 of Regulation (EU) 2016/429 requires operators keeping terrestrial animals other than bovine, ovine, caprine, porcine and equine animals to identify each animal by a physical means of identification and to ensure that those animals are accompanied by an identification or movement document when such rules have been adopted by the Commission pursuant to Article 118 thereof.












(23)


Article 118(1) of Regulation (EU) 2016/429 empowers the Commission to lay down detailed requirements for the means of identification of kept terrestrial animals and the rules for the identification and movement documents for those animals, as well as detailed rules for the computer databases provided for in that Regulation for kept bovine, ovine, caprine, porcine and equine animals, and rules on exchange of electronic data between computer databases of Member States for kept bovine animals. In addition, Article 118(2) of Regulation (EU) 2016/429 empowers the Commission to lay down requirements for alternative means of identification for kept terrestrial animals, as well as exemptions and special provisions for certain categories of those animals, and specific provisions for the identification and movement document for those animals, as well as rules on the identification and registration of kept terrestrial animals after their entry into the Union.












(24)


In addition, Article 119(1) of Regulation (EU) 2016/429 empowers the Commission to lay down rules concerning specific derogations for operators from certain identification and registration requirements laid down in that act. Article 122(2) of Regulation (EU) 2016/429 empowers the Commission to lay down traceability requirements for germinal products of kept terrestrial animals of species other that of the bovine, ovine, caprine, porcine and equine species.
Prior to the adoption of Regulation (EU) 2016/429, Union rules on the identification and registration of bovine, ovine, caprine, porcine and equine animals were laid down in Regulation (EC) No 1760/2000 of the European Parliament and of the Council (8), Council Regulation (EC) No 21/2004 (9), and Council Directives 2008/71/EC (10) and 2009/156/EC (11). Regulation (EU) 2016/429 repeals and replaces those four acts as from 21 April 2021. Those four acts laid down the rules on the means of identification, identification or movement documents and computer databases. They also provided the time periods for the application of the means of identification to those kept animals by operators. In addition, they also provided for a number of derogations and exemptions as regards the means of identification and movement documents without compromising the traceability of kept animals. The rules laid down in those acts have proven to be effective in ensuring the traceability of kept bovine, ovine, caprine, porcine and equine animals. Accordingly, the main substance of those rules should be maintained, but updated to take account of the practical experience gained in their application and current technical progress. The new time periods for the application of the means of identification to kept terrestrial animals by operators should be laid down by the Commission in an implementing act adopted in accordance with Article 120(2) of Regulation (EU) 2016/429.












(25)


To ensure that equine animals entering the Union are only identified in accordance with Union rules after their entry into the Union and where they remain in the Union, it is necessary to refer in this Regulation to the custom procedures laid down in Regulation (EU) No 952/2013 of the European Parliament and of the Council (12).












(26)


Prior to the adoption of Regulation (EU) 2016/429, Union rules on the traceability of kept dogs, cats and ferrets, and captive birds were laid down in Directive 92/65/EEC. The rules laid down in that Directive have proven to be effective in ensuring the traceability of those animals. Accordingly, the main substance of those rules should be maintained, but updated to take account of the practical experience gained in their application and current technical progress.












(27)


In addition, Directive 92/65/EEC lays down that in order to be the subject of trade, dogs, cats and ferrets should be accompanied by the same identification document as for non-commercial movement of pet animals provided for in Article 6(d) of Regulation (EU) No 576/2013 of the European Parliament and of the Council (13). Accordingly, this rule should be maintained in this Regulation.












(28)


Prior to the adoption of Regulation (EU) 2016/429, Union rules on the traceability of hatching eggs were laid down in Directive 2009/158/EC. The current system in relation to the marking of hatching eggs is well established. Accordingly, the main substance of those rules should be maintained in this Regulation but adapted to suit the framework of Regulation (EU) 2016/429.












(29)


Prior to the adoption of Regulation (EU) 2016/429, Union rules on the traceability of terrestrial animals kept in travelling circuses and animal acts were laid down in Commission Regulation (EC) No 1739/2005 (14). The rules laid down in that Regulation have also proven to be effective in ensuring the traceability of terrestrial animals kept in travelling circuses and animal acts. Accordingly, the main substance of those rules should be maintained, but updated to take account of the practical experience gained in their application.












(30)


Regulation (EU) 2016/429 provides that disease-specific rules for the prevention and control of diseases apply to the listed diseases referred to in Annex II to that Regulation, which include infection with Brucella abortus, B. melitensis and B. suis and infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis). Article 9 of Regulation (EU) 2016/429 provides for disease prevention and control rules to be applied to different categories of listed diseases. Commission Implementing Regulation (EU) 2018/1882 (15) provides that the disease prevention and control rules for listed diseases referred to in Article 9(1) of Regulation (EU) 2016/429 are to apply to the categories of listed diseases for the listed species and groups of listed species referred to in the Annex to that Implementing Regulation. Kept camelids and cervid animals are listed in the Annex to Implementing Regulation (EU) 2018/1882 as susceptible species for those infections. Therefore, this Regulation should establish harmonised rules on traceability for those animals.












(31)


Given the unique situation of reindeer husbandry which is strongly connected to the cultural heritage of Sami people in Northern Europe, Member States should be able to maintain specific regimes for the means of identification established for reindeers kept in their territory. Accordingly, this Regulation should provide for a specific regime for the identification of those animals.












(32)


As regards equine animals, Article 114 of Regulation (EU) 2016/429 provides that operators are to ensure that equine animals are individually identified by a correctly completed single lifetime identification document. In addition, Article 120(2) of that Regulation provides for the Commission to adopt implementing acts regarding certain requirements for that document. While the rules relating to the single lifetime identification document are now laid down as part of the animal health rules of the legal framework of Regulation (EU) 2016/429, it is necessary to take account of the identification requirements for those animals laid down elsewhere in Union law. In particular, account should be taken of Directive 2001/82/EC of the European Parliament and of the Council (16), Commission Implementing Regulation (EU) 2015/262 (17)
, Regulation (EU) 2016/1012 of the European Parliament and of the Council (18), Commission Delegated Regulation (EU) 2017/1940 (19) and Regulation (EU) 2019/6 of the European Parliament and of the Council (20) in order to avoid a proliferation of rules and identification documents, which would unnecessarily increase administrative and financial burdens. This need to rationalise Union rules is particularly important for equine animals, as they are used for a wide range of purposes, including sporting events, as breeding animals and also food. In addition, their use can vary depending on their life stage, so it is important that the single lifetime identification document remains valid for a number of uses. In addition, the transitional provisions laid down in this Regulation need to take account of the periods of application of those five acts in order to ensure coordination of applicable Union rules.












(33)


With a view to the uniform application of Union legislation on traceability of kept terrestrial animals and to ensure that it is clear and transparent, Commission Regulation (EC) No 509/1999 (21), Commission Regulation (EC) No 2680/1999 (22), Commission Decision 2000/678/EC (23), Commission Decision 2001/672/EC (24), Commission Regulation (EC) No 911/2004 (25), Commission Decision 2004/764/EC (26), Commission Regulation (EC) No 644/2005 (27), Regulation (EC) No 1739/2005, Commission Decision 2006/28/EC (28), Commission Decision 2006/968/EC (29), Commission Decision 2009/712/EC (30) and Implementing Regulation (EU) 2015/262 should be repealed by this Regulation. However, in order to ensure a smooth transition to the new legal framework for operators of travelling circuses and animal acts, the movement and identification documents in a format in accordance with Regulation (EC) No 1739/2005 should remain applicable until a date to be determined by the Commission in an implementing act adopted pursuant to Article 120(2) of Regulation (EU) 2016/429 with regard to the format of movement and identification documents for kept terrestrial animals in travelling circuses and animal acts.












(34)


Directive 2001/82/EC lays down specific rules for equine animals relating to the treatment of food-producing equine animals with regard to veterinary medical products, provided that those equine animals are identified in accordance with Union legislation and specifically marked in their identification document as not intended for slaughter for human consumption. Those rules are now laid down in substance in Regulation (EU) 2019/6, which repeals and replaces Directive 2001/82/EC. Regulation (EU) 2019/6 applies from 28 January 2022 and therefore after the date of application of Regulation (EU) 2016/429. But those two acts are inter-related, as Article 109(1) of Regulation (EU) 2019/6 provides for the Commission to adopt delegated acts in order to supplement that Regulation as regards information to be contained in the single lifetime identification document provided for Regulation (EU) 2016/429, for the purposes of the record-keeping obligations laid down in Regulation (EU) 2019/6. In addition, Implementing Regulation (EU) 2015/262 lays down rules on the identification of equidae, including rules on the identification documents for those animals, and it provides that the Union system for the identification of equidae comprises of, inter alia, a single lifetime document. Finally, Regulation (EU) 2016/1012 also lays down rules on the identification of equidae. It provides that the Commission is to adopt implementing acts laying down model forms for the single lifetime identification document.












(35)


In order to avoid unnecessary administrative and financial burdens for operators of kept equine animals and competent authorities, the lifetime identification document of kept equine animals currently laid down in Implementing Regulation (EU) 2015/262 should remain applicable until a date to be determined by the Commission in an implementing act adopted pursuant to Article 120(2) of Regulation (EU) 2016/429 and Article 109(2) of Regulation (EU) 2019/6 with regard to the format of single lifetime identification document of kept equine animals.












(36)


Article 271 of Regulation (EU) 2016/429 provides the transitional period for the new legal framework, laid down in that act, for operators as regards the identification of kept bovine, ovine, caprine and porcine animals and empowers the Commission to shorten that transitional period.












(37)


In order to ensure a smooth transition to the new legal framework established by Regulation (EU) 2016/429 for operators keeping terrestrial animals as regards the identification and registration of those animals and to the new legal framework as regards the animal health rules for movement of those animals, the rules laid down in this Regulation should apply from the same date as those laid down in Regulation (EU) 2016/429.












(38)


In order to ensure a smooth transition to the new legal framework for operators of establishments keeping terrestrial animals registered or approved in accordance with Directives 64/432/EEC and 92/65/EEC, Regulations (EC) No 1760/2000, (EC) No 21/2004, Directives 2008/71/EC, 2009/156/EC and 2009/158/EC, they should be deemed to be registered or approved in accordance with this Regulation. Member States should ensure that those operators comply with all the rules provided for in this Regulation.












(39)


In order to ensure a smooth transition to the new legal framework, bovine, ovine, caprine, porcine, equine, camelid and cervid animals, and psittacidae identified and registered before the date of application of this Regulation, should be considered to have been identified and registered in accordance with this Regulation and eligible for movement within the Union.












(40)


This Regulation should be applicable from 21 April 2021 in accordance with the date of application of Regulation (EU) 2016/429,





HAS ADOPTED THIS REGULATION:



PART I


SUBJECT MATTER, SCOPE AND DEFINITIONS



Article 1

Subject matter and scope


1.   This Regulation supplements the rules laid down in Regulation (EU) 2016/429 as regards:






(a)


registered and approved establishments for kept terrestrial animals and hatching eggs;










(b)


traceability requirements for the following kept terrestrial animals:






(i)


bovine, ovine, caprine, porcine, equine, camelid and cervid animals (ungulates);










(ii)


dogs, cats and ferrets;










(iii)


captive birds;










(iv)


hatching eggs;










(v)


terrestrial animals kept in travelling circuses and animal acts.










2.   Chapter 1 of Title I of Part II lays down the requirements for the registration of transporters of kept dogs, cats and ferrets, and poultry engaged in the transportation of those animals between Member States or between a Member State and a third country.


3.   Chapter 2 of Title I of Part II provides for derogations for operators of establishments for assembly operations of certain equine animals and of hatcheries of captive birds, from the requirement to apply to the competent authority for approval.
That Chapter also lays down the requirements for the approval of the following types of establishments:






(a)


establishments for assembly operations of ungulates and poultry from which those animals are to be moved to another Member State or which receive those animals from another Member State;










(b)


hatcheries from which hatching eggs or day-old chicks are to be moved to another Member State;










(c)


establishments keeping poultry from which poultry intended for purposes other than slaughter or hatching eggs are to be moved to another Member State.




Those requirements concern isolation and other biosecurity measures, surveillance measures, facilities and equipment, personnel and supervision by the competent authority.


4.   Chapter 3 of Title I of Part II lays down the requirements for the approval of the following types of establishments:






(a)


assembly centres of dogs, cats and ferrets from which those animals are to be moved to another Member State;










(b)


animal shelters for dogs, cats and ferrets from which those animals are to be moved to another Member State;










(c)


control posts;










(d)


environmentally isolated production establishments for bumble bees from which those animals are to be moved to another Member State;










(e)


quarantine establishments for kept terrestrial animals other than primates from which those animals are to be moved within the same Member State or to another Member State.




Those requirements concern quarantine, isolation and other biosecurity measures, surveillance and control measures, facilities and equipment, and supervision by the veterinarian.


5.   Chapter 4 of Title I of Part II lays down the requirements for the approval of confined establishments from which kept terrestrial animals are to be moved within the same Member State or to another Member State in relation to quarantine, isolation and other biosecurity measures, surveillance and control measures, facilities and equipment and supervision by the veterinarian.


6.   Chapter 1 of Title II of Part II lays down the information obligations of the competent authority as regards its registers of:






(a)


establishments of kept terrestrial animals;










(b)


hatcheries;










(c)


transporters of kept ungulates, dogs, cats and ferrets, and poultry engaged in the transportation of those animals between Member States or between a Member State and a third country;










(d)


operators conducting assembly operations for kept ungulates and poultry independently of an establishment.






7.   Chapter 2 of Title II of Part II lays down the information obligation of the competent authority as regards registers of approved establishments referred to in Chapters 2, 3 and 4 of Title I of Part II.


8.   Chapter 1 of Title III of Part II lays down the record-keeping obligations of operators, in addition to those provided for in Article 102(1) of Regulation (EU) 2016/429, for the following types of registered or approved establishments:






(a)


all establishments keeping terrestrial animals;










(b)


establishments keeping:






(i)


bovine, ovine, caprine and porcine animals;










(ii)


equine animals;










(iii)


poultry and captive birds;










(iv)


dogs, cats and ferrets;










(v)


honeybees;














(c)


travelling circuses and animal acts;










(d)


animal shelters for dogs, cats and ferrets;










(e)


control posts;










(f)


quarantine establishments for kept terrestrial animals other than primates;










(g)


confined establishments.






9.   Chapter 2 of Title III of Part II lays down the record-keeping obligations of operators of registered or approved hatcheries, in addition to those provided for in Article 103(1) of Regulation (EU) 2016/429.


10.   Chapter 3 of Title III of Part II lays down the record-keeping obligations of registered transporters, in addition to those provided for in Article 104(1) of Regulation (EU) 2016/429.


11.   Chapter 4 of Title III of Part II lays down the record-keeping obligations of operators conducting assembly operations, in addition to those provided for in Article 105(1) of Regulation (EU) 2016/429, for






(a)


operators of registered or approved establishments for assembly operations of kept ungulates and poultry;










(b)


operators conducting assembly operations of kept ungulates and poultry independently from an establishment;










(c)


operators of assembly centres of dogs, cats and ferrets registered with the competent authority.






12.   Titles I to IV of Part III lay down traceability requirements for kept animals of the bovine, ovine and caprine, porcine and equine species, including the means of identification, documentation and computer databases.


13.   Chapter 1 of Title V of Part III lays down traceability requirements for kept dogs, cats and ferrets, including those for pet animals when they are moved to another Member State for other than non-commercial purposes.


14.   Chapter 2 of Title V of Part III lays down traceability requirements for kept camelid and cervid animals.


15.   Chapter 3 of Title V of Part III lays down traceability requirements for kept captive birds.


16.   Chapter 4 of Title V of Part III lays down traceability requirements for kept terrestrial animals in travelling circuses and animal acts.


17.   Title VI of Part III lays down traceability requirements for hatching eggs.


18.   Title VII of Part III lays down traceability requirements for kept bovine, ovine, caprine, porcine, equine, cervid and camelid animals after their entry into the Union.


19.   Part IV lays down certain transitional measures with regard to Directives 64/432/EEC and 92/65/EEC, Regulations (EC) No 1760/2000, (EC) No 21/2004 and (EC) No 1739/2005, Directives 2008/71/EC, 2009/156/EC and 2009/158/EC, and Implementing Regulation (EU) 2015/262 in relation to:






(a)


the registration and approval of establishments;










(b)


the identification of kept terrestrial animals;










(c)


the movement and identification documents for kept terrestrial animals in travelling circuses and animal acts;










(d)


the single lifetime identification document for kept equine animals.







Article 2

Definitions

For the purposes of this Regulation, the following definitions shall apply:






(1)


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










(2)


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










(3)


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










(4)


‘type of transport’ means the way transportation is carried out, such as by road, rail, air or water;










(5)


‘means of transport’ means road or rail vehicles, vessels and aircrafts;










(6)


‘day-old chicks’ means all poultry less than 72 hours old;










(7)


‘assembly centre of dogs, cats and ferrets’ means an establishment where those animals of the same health status are assembled from more than one establishment;










(8)


‘animal shelter’ means an establishment where former stray, feral, lost, abandoned or confiscated terrestrial animals are kept and whose health status might not be known for all of them at the time of entry into the establishment;










(9)


‘control posts’ means control posts as referred to in Regulation (EC) No 1255/97;










(10)


‘environmentally isolated production establishment’ means an establishment where its structures together with its strict biosecurity measures, ensure an effective isolation of the production of animals from the associated facilities and from the environment;










(11)


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










(12)


‘primates’ means animals of the species belonging to the order Primates excluding humans;










(13)


‘honeybees’ means animals of the Apis mellifera species;










(14)


‘establishment veterinarian’ means a veterinarian responsible for the activities carried out at the quarantine establishment for kept terrestrial animals other than primates or at confined establishment as laid down in this Regulation;










(15)


‘unique registration number’ means a number assigned by the competent authority to a registered establishment as referred to in Article 93 of Regulation (EU) 2016/429;










(16)


‘unique approval number’ means a number assigned by the competent authority to an establishment approved by it in accordance with Articles 97 and 99 of Regulation (EU) 2016/429;










(17)


‘unique code’ means the unique code whereby operators keeping kept animals of the equine species are required to ensure that those animals are individually identified as provided for in Article 114(1)(a) of Regulation (EU) 2016/429 and which is recorded in the computer database of the Member State provided for in Article 109(1) of that Regulation;










(18)


‘identification code of the animal’ means the individual code displayed by the means of identification applied to an animal and comprising:






(a)


the country code of the Member State where the means of identification was applied to the animal;










(b)


followed by the numeric individual identification number assigned to the animal not exceeding 12 digits;














(19)


‘bovine animal’ or ‘animal of the bovine species’ 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;










(20)


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










(21)


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










(22)


‘porcine animal’ or ‘animal of the porcine species’ means an animal of the species of ungulates of family Suidae listed in Annex III to Regulation (EU) 2016/429;










(23)


‘electronic identifier’ means a marker with radio frequency identification (‘RFID’);










(24)


‘animal of the equine species’ or ‘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;










(25)


‘computer database’ means a computer database of kept terrestrial animals as provided for in Article 109(1) of Regulation (EU) 2016/429;










(26)


‘supply chain’ means an integrated production chain of a common health status as regards listed diseases consisting of a collaborative network of specialised establishments approved by the competent authority for the purpose of Article 53, between which porcine animals are moved to complete the production cycle;










(27)


‘single lifetime identification document’ means the single lifetime document whereby operators keeping kept animals of the equine species are required to ensure that those animals are individually identified, as provided for in Article 114(1)(c) of Regulation (EU) 2016/429;










(28)


‘breed society’ means any breeders’ association, breeding organisation or public body, other than competent authorities, which is recognised by the competent authority of a Member State in accordance with Article 4(3) of Regulation (EU) 2016/1012 for the purpose of carrying out a breeding programme on purebred breeding animals entered in the breeding book(s) it maintains or establishes;










(29)


‘breeding body’ means any breeders’ association, breeding organisation, private undertaking, stock-rearing organisation or official service in a third country which, in respect of purebred breeding animals of the bovine, porcine, ovine, caprine or equine species or of hybrid breeding pigs, has been accepted by that third country in connection with the entry into the Union of breeding animals for breeding;










(30)


‘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 Articles 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’);














(31)


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










(32)


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










(33)


‘reindeer’ means an ungulate animal of the Rangifer
tarandus species listed in Annex III to Regulation (EU) 2016/429;










(34)


‘travelling circus’ means an exhibition or fair that includes animals or animal acts which is intended to move between Member States;










(35)


‘animal act’ any act featuring animals kept for the purpose of an exhibition or fair, and which may form part of a circus;










(36)


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










(37)


‘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.







PART II


REGISTRATION, APPROVAL, REGISTERS AND RECORD-KEEPING



TITLE I


REGISTRATION AND APPROVAL OF TRANSPORTERS AND OPERATORS OF ESTABLISHMENTS BY THE COMPETENT AUTHORITY




CHAPTER 1




Registration of transporters of kept terrestrial animals other than ungulates for transport between Member States and for transport to third countries




Article 3

Registration obligations of transporters of kept dogs, cats and ferrets, and poultry


1.   Transporters engaged in the transportation of kept dogs, cats and ferrets, and poultry between Member States or between a Member State and a third country shall, in order to be registered in accordance with Article 93 of Regulation (EU) 2016/429, before they commence such activities provide the competent authority with information on:






(a)


the name and address of the transporter concerned;










(b)


the species for which transportation is planned;










(c)


the type of transport;










(d)


the means of transport.






2.   Transporters of kept dogs, cats and ferrets, as referred to in paragraph 1, shall inform the competent authority of the numbers of animals for which transportation is planned.


3.   Transporters of poultry, as referred to in paragraph 1, shall inform the competent authority of the categories of poultry for which transportation is planned.


4.   Transporters as referred to in paragraph 1 shall inform the competent authority of any:






(a)


change concerning the matters referred to in paragraphs 1, 2 and 3;










(b)


cessation of the transport activity.









CHAPTER 2




Approval of establishments for assembly operations of ungulates and poultry, hatcheries and establishments keeping poultry




Article 4

Derogations from the requirement to apply to the competent authority for approval for operators of establishments for assembly operations of certain equine animals and of hatcheries of captive birds

Operators of the following establishments shall not apply to the competent authority for approval of their establishments in accordance with Article 96(1) of Regulation (EU) 2016/429:






(a)


establishments for assembly operations of equine animals where those animals are gathered for the purposes of competitions, races, shows, training, collective leisure or work activities or in the context of breeding activities;










(b)


hatcheries of captive birds.






Article 5

Requirements for granting approval of establishments for assembly operations of ungulates

When granting approval of establishments for assembly operations of ungulates, from which those animals are to be moved to another Member State or which receive those animals from another Member State, the competent authority shall ensure that such establishments comply with the following requirements set out in Part 1 of Annex I hereto:






(a)


point 1, in relation to isolation and other biosecurity measures;










(b)


point 2, in relation to facilities and equipment;










(c)


point 3, in relation to personnel;










(d)


point 4, in relation to supervision by the competent authority.






Article 6

Requirements for granting approval of establishments for assembly operations of poultry

When granting approval of establishments for assembly operations of poultry from which those animals are to be moved to another Member State or which receive those animals from another Member State, the competent authority shall ensure that such establishments comply with the following requirements set out in Part 2 of Annex I hereto:






(a)


point 1, in relation to isolation and other biosecurity measures;










(b)


point 2, in relation to facilities and equipment;










(c)


point 3, in relation to personnel;










(d)


point 4, in relation to supervision by the competent authority.






Article 7

Requirements for granting approval of hatcheries

When granting approval of hatcheries from which hatching eggs of poultry or day-old chicks are to be moved to another Member State, the competent authority shall ensure that such establishments comply with the following requirements set out in:






(a)


point 1 of Part 3 of Annex I, in relation to biosecurity measures;










(b)


point 2 of Part 3 of Annex I and Parts 1 and 2 of Annex II, in relation to surveillance;










(c)


point 3 of Part 3 of Annex I, in relation to facilities and equipment;










(d)


point 4 of Part 3 of Annex I, in relation to personnel;










(e)


point 5 of Part 3 of Annex I, in relation to supervision by the competent authority.






Article 8

Requirements for granting approval of establishments keeping poultry

When granting approval of establishments keeping poultry from which poultry intended for purposes other than slaughter or hatching eggs are to be moved to another Member State, the competent authority shall ensure that such establishments comply with the following requirements set out in:






(a)


point 1 of Part 4 of Annex I, in relation to biosecurity measures;










(b)


point 2 of Part 4 of Annex I and Part 2 of Annex II, in relation to surveillance;










(c)


point 3 of Part 4 of Annex I, in relation to facilities and equipment.








CHAPTER 3




Approval of establishments keeping terrestrial animals




Article 9

Obligation on operators of certain type of establishments keeping terrestrial animals to apply to the competent authority for approval

Operators of the following types of establishments shall apply to the competent authority for approval in accordance with Article 96(1) of Regulation (EU) 2016/429 and shall not commence their activities until their establishment has been approved:






(a)


assembly centres of dogs, cats and ferrets from which those animals are moved to another Member State;










(b)


animal shelters of dogs, cats and ferrets from which those animals are moved to another Member State;










(c)


control posts;










(d)


environmentally isolated production establishments for bumble bees from which those animals are moved to another Member State;










(e)


quarantine establishments for kept terrestrial animals other than primates from which those animals are moved within the same Member State or to another Member State.






Article 10

Requirements for granting approval of assembly centres of dogs, cats and ferrets

When granting approval of assembly centres of dogs, cats and ferrets from which those animals are to be moved to another Member State, the competent authority shall ensure that such establishments comply with the following requirements set out in Part 5 of Annex I hereto:






(a)


point 1, in relation to isolation and other biosecurity measures;










(b)


point 3, in relation to facilities and equipment.






Article 11

Requirements for granting approval of animal shelters of dogs, cats and ferrets

When granting approval of animal shelters from which dogs, cats and ferrets are to be moved to another Member State, the competent authority shall ensure that such establishments comply with the following requirements set out in Part 5 of Annex I hereto:






(a)


point 2, in relation to isolation and other biosecurity measures;










(b)


point 3, in relation to facilities and equipment.






Article 12

Requirements for granting approval of control posts

When granting approval of control posts, the competent authority shall ensure that such control posts comply with the following requirements set out in Part 6 of Annex I hereto:






(a)


point 1, in relation to isolation and other biosecurity measures;










(b)


point 2, in relation to facilities and equipment.






Article 13

Requirements for granting approval of environmentally isolated production establishments for bumble bees

When granting approval for environmentally isolated production establishments for bumble bees from which bumble bees are to be moved to another Member State, the competent authority shall ensure that such establishments comply with the following requirements set out in Part 7 of Annex I hereto:






(a)


point 1, in relation to biosecurity and surveillance measures;










(b)


point 2, in relation to facilities and equipment.






Article 14

Requirements for granting approval of quarantine establishments for kept terrestrial animals other than primates

When granting approval for quarantine establishments for kept terrestrial animals other than primates from which those animals are to be moved within the same Member State or to another Member State, the competent authority shall ensure that such establishment comply with the following requirements set out in Part 8 of Annex I hereto:






(a)


point 1, in relation to quarantine, isolation and other biosecurity measures;










(b)


point 2, in relation to surveillance and control measures;










(c)


point 3, in relation to facilities and equipment.






Article 15

Obligations on operators of quarantine establishments for kept terrestrial animals other than primates

Operators of quarantine establishments for kept terrestrial animals other than primates referred to in Article 14 shall:






(a)


put in place the necessary arrangements to perform veterinary post-mortem inspections in appropriate facilities in the establishment or in a laboratory;










(b)


secure by contract or by means of another legal instrument the services of an establishment veterinarian who shall be responsible for:






(i)


supervising the activities of the establishment and compliance with the requirements for approval laid down in Article 14;










(ii)


reviewing the disease surveillance plan referred to in point 2(a) of Part 8 of Annex I whenever required and at least annually.












CHAPTER 4




Approval of confined establishments from which terrestrial animals are to be moved within a Member State or to another Member State




Article 16

Requirements for granting approval of status of confined establishments for terrestrial animals

When granting approval of a confined establishment for terrestrial animals which are to be moved within the same Member State or to another Member State, the competent authority shall ensure that such establishments comply with the following requirements set out in Part 9 of Annex I hereto:






(a)


point 1, in relation to quarantine, isolation and other biosecurity measures;










(b)


point 2, in relation to surveillance and control measures;










(c)


point 3, in relation to facilities and equipment.






Article 17

Obligations on operators of confined establishments for terrestrial animals

Operators of confined establishments for terrestrial animals referred to in Article 16 shall:






(a)


put in place the necessary arrangements to perform veterinary post-mortem inspections in appropriate facilities in the establishment or in a laboratory;










(b)


secure by contract or by means of another legal instrument the services of an establishment veterinarian who shall be responsible for:






(i)


supervising of the activities of the establishment and compliance with the requirements for approval laid down in Article 16;










(ii)


reviewing of the disease surveillance plan referred to in point 2(a) of Part 9 of Annex I whenever required and at least annually.












TITLE II


REGISTERS TO BE KEPT BY THE COMPETENT AUTHORITY OF REGISTERED AND APPROVED TRANSPORTERS AND OPERATORS OF ESTABLISHMENTS




CHAPTER 1




Registers of establishments, transporters and operators registered with the competent authority




Article 18

Information obligation of the competent authority as regards registers of establishments of kept terrestrial animals and hatcheries

The competent authority shall include in its register of establishments of kept terrestrial animals and of hatcheries registered with it the following information for each establishment:






(a)


the unique registration number assigned to it;










(b)


the date of registration with the competent authority;










(c)


the name and address of the operator of the establishment;










(d)


the address and geographical coordinates (latitude and longitude) of the location of the establishment;










(e)


a description of its facilities;










(f)


the type of establishment;










(g)


the species, categories and numbers of terrestrial animals or hatching eggs which are kept on the establishment;










(h)


the period during which animals or hatching eggs are kept on the establishment if it is not continuously occupied, including seasonal occupation or occupation during particular events;










(i)


the health status of the establishment where one has been assigned to it by the competent authority;










(j)


the restrictions on movements of animals, hatching eggs or products to and from the establishment, where such restrictions are applied by the competent authority;










(k)


the date of any cessation of activity when the operator has informed the competent authority thereof.






Article 19

Information obligation of the competent authority as regards registers of transporters of kept ungulates, dogs, cats and ferrets, and poultry


1.   The competent authority shall include, in its register of transporters engaged in the transportation between Member States or between a Member State and a third country of kept ungulates, dogs cats and ferrets, and poultry, registered with it, the following information for each transporter:






(a)


the unique registration number assigned to it;










(b)


the date of registration with the competent authority;










(c)


the name and address of the operator;










(d)


the species for which transportation is planned;










(e)


the type of transport;










(f)


the means of transport;










(g)


the date of any cessation of activity when the operator has informed the competent authority thereof.






2.   For each transporter of kept ungulates, dogs cats and ferrets, as referred to in paragraph 1, the competent authority shall include information in its register of transporters on the number of animals for which transportation is planned.


3.   For each transporter of poultry as referred to in paragraph 1, the competent authority shall include information in its register of transporters on the categories of poultry for which transportation is planned.



Article 20

Information obligation of the competent authority as regards registers of operators conducting assembly operations for kept ungulates and poultry independently of an establishment

The competent authority shall include in its register of operators conducting assembly operations for kept ungulates and poultry registered with it, independently of an establishment, including those who buy and sell those animals, the following information for each operator:






(a)


the unique registration number assigned to it;










(b)


the date of registration with the competent authority;










(c)


the name and address of the operator;










(d)


the species and categories of kept ungulates and poultry to be assembled;










(e)


the date of any cessation of activity when the operator has informed the competent authority thereof.








CHAPTER 2




Registers of establishments approved by the competent authority




Article 21

Information obligation of the competent authority as regards registers of approved establishments

The competent authority shall include in its register of approved establishments referred to in Chapters 2, 3 and 4 of Title I of Part II, the following information for each establishment:






(a)


the unique approval number assigned by the competent authority;










(b)


the date of approval granted by the competent authority or of any suspension or withdrawal of such approval;










(c)


the name and address of the operator;










(d)


the address and geographical coordinates (latitude and longitude) of the location of the establishment;










(e)


a description of its facilities;










(f)


the type of establishment;










(g)


the species, categories and numbers of terrestrial animals or hatching eggs or day-old chicks kept on the establishment;










(h)


the period during which animals are kept on the establishment if it is not continuously occupied, including seasonal occupation or occupation during particular events;










(i)


the health status assigned to the establishment if one is assigned by the competent authority;










(j)


the restrictions imposed on movements of animals or germinal products to and from the establishment by the competent authority, where such restrictions are imposed;










(k)


the date of any cessation of activity when the operator has informed the competent authority thereof.








TITLE III


RECORD-KEEPING OBLIGATIONS OF OPERATORS IN ADDITION TO THOSE PROVIDED FOR IN REGULATION (EU) 2016/429




CHAPTER 1




Operators of establishments registered or approved with the competent authority




Article 22

Record-keeping obligations of operators of all establishments keeping terrestrial animals

Operators of all registered or approved establishments keeping terrestrial animals shall record the following information:






(a)


the identification code of each identified animal as displayed by means of identification, where applied, kept on the establishment;










(b)


the unique registration or approval number of the establishment of origin of the animals, where they originate in another establishment;










(c)


the unique registration or approval number of the establishment of destination of the animals, where they are destined for another establishment.






Article 23

Record-keeping obligations of operators of establishments keeping bovine, ovine, caprine and porcine animals


1.   Operators of registered establishments keeping bovine, ovine, caprine and porcine animals shall record the following information concerning those animals:






(a)


the date of birth of each animal kept on the establishment;










(b)


the date of natural death, slaughter or loss of each animal on the establishment;










(c)


the type of electronic identifier or tattoo and its location, if applied to the animal;










(d)


the initial identification code of each identified animal, where such code has been changed and the reason for that change.






2.   Operators of establishments keeping ovine and caprine animals, shall record the information referred to in paragraph 1(a) in a format of the year of the birth of each such animal kept on the establishment.


3.   Operators of establishments keeping porcine animals shall be exempted from recording the information referred to in paragraph 1(a).


4.   Where ovine, caprine or porcine animals kept on the establishment are only identified by the unique identification number of their establishment of birth, the operators of establishments shall record the information referred to in paragraph 1 for each group of animals having the same unique identification number of their establishment of birth and the total number of animals in that group.


5.   Where porcine animals kept on the establishment are not identified in accordance with Article 53, the operators of establishments shall:






(a)


not be required to record the information referred to in paragraph 1;










(b)


record for each group of animals moved from their establishment, the information referred to in Article 102(1)(b) of Regulation (EU) 2016/429 and the total number of animals in that group.







Article 24

Record-keeping obligations of operators of establishments keeping equine animals

Operators of registered establishments keeping equine animals shall record the following information for each kept equine animal:






(a)


the unique code;










(b)


the date of birth on the establishment;










(c)


the date of natural death, loss or slaughter on the establishment.






Article 25

Record-keeping obligations of operators of establishments keeping poultry and captive birds

Operators of registered or approved establishments keeping poultry and operators of establishments keeping captive birds shall record the following information:






(a)


the production performances for poultry;










(b)


the morbidity rate for the poultry and captive birds on the establishment together with information concerning the cause.






Article 26

Record-keeping obligations of operators of establishments keeping dogs, cats and ferrets

Operators of registered establishments keeping dogs, cats and ferrets shall record the following information for each such animal:






(a)


the date of birth;










(b)


the date of death or loss on the establishment.






Article 27

Record-keeping obligations of operators of establishments keeping honeybees

Operators of registered establishments keeping honeybees shall record for each apiary the details of temporary transhumance, if any, of the kept beehives, comprising information covering at least the place of each transhumance, its date of start and finish, and the number of the beehives moved.


Article 28

Record-keeping obligations of operators of travelling circuses and animal acts

Operators of registered travelling circuses and animal acts shall record the following information for each animal:






(a)


the date of death or loss of the animal on the establishment;










(b)


the name and address of the operator having responsibility for the animals or the pet owner;










(c)


details on the movements of travelling circuses and animal acts.






Article 29

Record-keeping obligations of operators of animal shelters for dogs, cats and ferrets

Operators of approved animal shelters for dogs, cats and ferrets shall record the following information for each such animal:






(a)


the estimated age and sex, breed or colour of coat;










(b)


the date of application or the date of reading of the injectable transponder;










(c)


the observations made on incoming animals during the isolation period;










(d)


the date of death or loss on the establishment.






Article 30

Record-keeping obligations of operators of control posts

Operators of approved control posts shall record the licence plate number or registration number of the means of transport unloading animals and the unique registration number of the transporter where available.


Article 31

Record-keeping obligations of operators of quarantine establishments for kept terrestrial animals other than primates

Operators of approved quarantine establishments for kept terrestrial animals other than primates shall record the following information:






(a)


the estimated age and sex of animals kept on the establishment;










(b)


the licence plate number or registration number of the means of transport unloading and loading animals and the unique registration number of the transporter where available;










(c)


details of the implementation and results of the disease surveillance plan provided for in point 2(a) of Part 8 of Annex I;










(d)


the results of clinical and laboratory tests and of post-mortem testing provided for in point 2(b) of Part 8 of Annex I;










(e)


details of the vaccination and treatment of susceptible animals provided for in point 2(c) of Part 8 of Annex I;










(f)


instructions, if any, of the competent authority as regards observations made during any isolation or quarantine period.






Article 32

Record-keeping obligations of operators of confined establishments

Operators of approved confined establishments shall record the following additional information:






(a)


the estimated age and sex of animals kept on the establishment;










(b)


the licence plate number or registration number of the means of transport unloading and loading animals and the unique registration number of the transporter where available;










(c)


details of the implementation and results of the disease surveillance plan provided for in point 2(a) of Part 9 of Annex I;










(d)


the results of clinical, laboratory tests and post-mortem testing provided for in point 2(b) of Part 9 of Annex I;










(e)


details of the vaccination and treatment of susceptible animals provided for in point 2(c) of Part 9 of Annex I;










(f)


details of isolation or quarantine of incoming animals, instructions, if any, of the competent authority as regards isolation and quarantine and observations made during any isolation or quarantine period.








CHAPTER 2




Hatcheries




Article 33

Record-keeping obligations of operators of hatcheries

Operators of registered or approved hatcheries shall record the following information for each flock:






(a)


the species and number of day-old chicks or hatchlings of other species or hatching eggs kept at the hatchery;










(b)


movements of day-old chicks, hatchlings of other species and hatching eggs into and out of their establishments, stating as appropriate:






(i)


their place of origin or intended destination, including the unique registration or approval number of the establishment as appropriate;










(ii)


the dates of such movements;














(c)


the number of incubated eggs which have not hatched and their intended destination, including the unique registration or approval number of the establishment as appropriate;










(d)


hatching yields;










(e)


details of any vaccination programmes.








CHAPTER 3




Transporters registered with the competent authority




Article 34

Record-keeping obligations of registered transporters of kept terrestrial animals

Registered transporters shall record the following additional information for each means of transport used for the transport of kept terrestrial animals:






(a)


the licence plate number or registration number;










(b)


the dates and times of loading of the animals at the establishment of origin;










(c)


the name, address and unique registration or approval number of each establishment visited;










(d)


the dates and times of unloading of animals at the establishment of destination;










(e)


the dates and the places of cleaning, disinfection and disinfestation of the means of transport;










(f)


the reference numbers of the documents accompanying the animals.








CHAPTER 4




Operators conducting assembly operations




Article 35

Record-keeping obligations of operators of establishments of assembly operations of kept ungulates and poultry

Operators of registered or approved establishments for assembly operations of kept ungulates and poultry shall record the following information:






(a)


the date of death and loss of animals on the establishment;










(b)


the licence plate number or registration number of the means of transport loading or unloading the animals and the unique registration number of the transporter of those animals where available;










(c)


the reference numbers of the documents required to accompany animals.






Article 36

Record-keeping obligations of operators conducting assembly operations of kept ungulates and poultry independently of an establishment

Registered operators conducting assembly operations for kept ungulates and poultry independently of an establishment shall record the following information for each animal subject to purchase:






(a)


the unique approval or registration number of the establishment for assembly operations through which the animal has passed after leaving the establishment of origin and prior to its purchase, where available;










(b)


the date of purchase;










(c)


the name and address of the purchaser of the animal;










(d)


the licence plate or registration number of the means of transport loading or unloading the animals and the unique registration number of the transporter, where available;










(e)


the reference numbers of the documents required to accompany the animals.






Article 37

Record-keeping obligations of operators of assembly centres of dogs, cats and ferrets

Operators of approved assembly centres of dogs, cats and ferrets shall record the licence plate number or registration number of the means of transport loading or unloading the animals and the unique registration number of the transporter, where available.





PART III


TRACEABILITY OF KEPT TERRESTRIAL ANIMALS AND HATCHING EGGS



TITLE I


TRACEABILITY OF KEPT BOVINE ANIMALS




CHAPTER 1




Means and methods of identification




Article 38

Obligations on operators keeping bovine animals as regards the means and methods of identification of kept bovine animals, their application and use


1.   Operators keeping bovine animals shall ensure that bovine animals are individually identified by means of a conventional ear tag as referred to in point (a) of Annex III which must:






(a)


be attached to each ear flap of the animal with a visible, legible and indelible display of the identification code of the animal on the means of identification;










(b)


be applied to bovine animals on the establishment of birth;










(c)


not be removed, modified or replaced without the permission of the competent authority of the Member State where the bovine animals are kept.






2.   Operators keeping bovine animals may replace:






(a)


one of a conventional ear tag referred to in paragraph 1 by an electronic identifier approved by the competent authority of the Member State where the bovine animals are kept;










(b)


both conventional ear tags referred to in paragraph 1 by an electronic identifier approved by the competent authority of the Member State where the bovine animals are kept in accordance with the exemptions provided for in Article 39(1).







Article 39

Exemptions granted by the competent authority for operators of confined establishments and for operators to identify bovine animals kept for cultural, historical, recreational, scientific or sporting purposes


1.   The competent authority may exempt operators of confined establishments and operators keeping bovine animals for cultural, historical, recreational, scientific or sporting purposes from the identification requirements for bovine animals provided for in Article 38(1)(a).


2.   When granting exemptions as provided in paragraph 1, the competent authority shall ensure that at least one of the means of identification listed in points (d) and (e) of Annex III is approved by the competent authority for the application of the means of identification of bovine animals kept by operators exempted in accordance with paragraph 1 of this Article.
The competent authority shall establish procedures for application by operators when requesting such an exemption as provided in paragraph 1 of this Article.



Article 40

Special provisions for the identification of bovine animals of breeds reared specifically for traditional cultural and sporting events

The competent authority may authorise operators keeping bovine animals of breeds reared specifically for traditional cultural and sporting events to identify those animals individually by an alternative means of identification authorised by the competent authority after the removal of conventional ear tag referred to in Article 38(1)(a) provided that an unequivocal link between the identified animal and its identification code is maintained.


Article 41

Replacement of the conventional ear tag for kept bovine animals as referred to in Article 38(1)


1.   Member States may authorise one of the conventional ear tags referred to in Article 38(1)(a) to be replaced by one of the means of identification listed in points (c), (d) and (e) of Annex III for all or specific categories of bovine animals kept in their territory.


2.   Member States shall ensure that the means of identification listed in points (a), (c), (d) and (e) of Annex III comply with the following requirements:






(a)


they display the identification code of the animal;










(b)


they are approved by the competent authority of the Member State where the bovine animals are kept.






3.   Member States shall establish procedures for the following:






(a)


application by manufacturers for approval of means of identification for bovine animals kept in their territory;










(b)


application by operators keeping bovine animals for the means of identification to be allocated to their establishment.






4.   Member State shall establish and make available to the public of the list of breeds of bovine animals reared specifically for traditional cultural and sporting events kept in its territory.





CHAPTER 2




Computer database




Article 42

Rules for information in computer database of kept bovine animals

The competent authority shall store the information referred to in Article 109(1)(a) of Regulation (EU) 2016/429 for each kept bovine animal in a computer database in accordance with the following rules:






(a)


the identification code of the animal must be recorded;










(b)


the type of electronic identifier, if applied to the bovine animal, must be recorded as listed in points (c), (d) and (e) of Annex III;










(c)


the following information must be recorded for establishments keeping bovine animals:






(i)


the unique registration number assigned to it;










(ii)


the name and address of the operator of establishment;














(d)


the following information must be recorded for each movement of bovine animal into and from the establishment:






(i)


the unique registration number of the establishments of origin and destination;










(ii)


the date of arrival;










(iii)


the date of departure;














(e)


the date of natural death, loss or slaughter of bovine animal on the establishment must be recorded.






Article 43

Rules on the exchange of electronic data between computer databases of Member States in respect of bovine animals


1.   Member States shall ensure that their computer databases in respect of bovine animals complies with the following requirements:






(a)


they are secured in accordance with applicable national law;










(b)


they contain at least the up-to-date information provided for in Article 42.






2.   Member States shall ensure that their computer databases is managed by an information system capable of applying and managing qualified electronic signatures for data exchange messages to guarantee non-repudiation concerning:






(a)


the authenticity of exchanged messages so that guarantees are provided on the origin of the message;










(b)


the integrity of exchanged messages so that guarantees are provided that the message has not been altered or corrupted;










(c)


the temporal information of exchanged messages so that guarantee are provided that they were sent at a specific time.






3.   Member State shall, without any undue delay but in any event within a period of 24 hours of becoming aware of it, notify the Member State with whom electronic data exchange has been established, of any breach of security or loss of integrity that has a significant impact on the data validity or on the personal data maintained therein.





CHAPTER 3




Identification document




Article 44

Identification document of kept bovine animals

Identification document of kept bovine animals provided for in Article 112(b) of Regulation (EU) 2016/429 shall contain the following information:






(a)


the information provided for in Article 42(a) to (d);










(b)


the date of birth of each animal;










(c)


the name of issuing competent authority, or the issuing body to which the task was assigned;










(d)


the date of issuance.








TITLE II


TRACEABILITY OF KEPT OVINE AND CAPRINE ANIMALS




CHAPTER 1




Means and methods of identification




Article 45

Obligations on operators of kept ovine and caprine animals as regards the means and methods of identification of those animals, their application and use


1.   Operators keeping ovine and caprine animals intended to be moved directly to a slaughterhouse before the age of 12 months shall ensure that each such animal is identified by at least a conventional ear tag attached to an ear flap of the animal or a conventional pastern band as listed in point (a) or (b) of Annex III with a visible, legible and indelible display of, either:






(a)


the unique registration number of the establishment of birth of animal;




or






(b)


the identification code of the animal.






2.   Operators keeping ovine and caprine animals not intended to be moved directly to slaughterhouse before the age of 12 months shall ensure that each such animal is individually identified as follows:






(a)


by a conventional ear tag as listed in point (a) of Annex III with a visible, legible and indelible display of the identification code of the animal;




and






(b)


by one of the means of identification listed in points (c) to (f) of Annex III approved by the competent authority of the Member State where the ovine and caprine animals are kept with legible and indelible display of the identification code of the animal.






3.   Operators keeping ovine and caprine animals shall ensure that:






(a)


the means of identification are applied to ovine and caprine animals on the establishment of birth;










(b)


no means of identification are removed, modified or replaced without the permission of the competent authority.






4.   Operators keeping ovine and caprine animals may replace:






(a)


one of the approved means of identification referred to in paragraph 2 in accordance with the derogations provided for in Article 46(1), (2), (3) and (4);










(b)


both means of identification referred to in paragraph 2 of this Article by an electronic identifier approved by the competent authority of the Member State where the ovine and caprine animals are kept in accordance with the exemptions provided for in Article 47(1).







Article 46

Derogations from the requirements laid down in Article 45 as regards the means and methods of identification of kept ovine and caprine animals, their application and use


1.   By way of derogation from the requirement laid down in Article 45(2)(a), operators keeping ovine and caprine animals belonging to a population of animals that are born with ears that are too small to attach a conventional ear tag as listed in point (a) of Annex III, shall ensure that such animals are individually identified by a conventional pastern band as listed in point (b) of that Annex with a visible, legible and indelible display of the identification code of the animal.


2.   By way of derogation from the requirement laid down in Article 45(2)(a), operators keeping ovine and caprine animals not intended to be moved to another Member State may replace the a conventional ear tag as listed in point (a) of Annex III by a tattoo listed in point (g) of that Annex with a visible, legible and indelible display of the identification code of the animal provided that the competent authority has authorised the use of a ruminal bolus as listed in point (d) of that Annex.


3.   By way of derogation from Article 45(2)(b), operators keeping ovine and caprine animals not intended to be moved to another Member State and the operators keeping ovine or caprine animals exempted from the application of an electronic identifier in accordance with Article 48, may replace the electronic identifier by a tattoo as listed in point (g) of Annex III with visible, legible and indelible display of the identification code of the animal.


4.   By way of derogation from Article 45(2), operators keeping ovine and caprine animals intended to be transported to the slaughterhouse either after undergoing an assembly operation or after undergoing a fattening operation in another establishment may identify each animal at least by an electronic ear tag as listed in point (c) of Annex III attached to an ear flap of the animal with visible, legible and indelible display of the unique registration number of the establishment of birth of animal and with legible and indelible display of the identification code of that animal provided that those animals:






(a)


are not intended to be moved to another Member State;




and






(b)


are slaughtered before the age of 12 months.







Article 47

Exemptions from the requirements of Article 45(2) for operators of confined establishments and those keeping animals for cultural, recreational or scientific purposes


1.   The competent authority may exempt operators of confined establishments and operators keeping ovine and caprine animals for cultural, recreational or scientific purposes from identification requirements of Article 45(2) subject the conditions laid down in paragraph 2 of this Article.


2.   The competent authority shall ensure that either a ruminal bolus as listed in points (d) of Annex III, or an injectable transponder as listed in point (e) of that Annex III, has been authorised by it for the identification of the ovine and caprine animals referred to in paragraph 1, and that such authorised means of identification complies with the requirements laid down in Article 48(3).
The competent authority shall establish procedures for application by operators when requesting such an exemption as provided in paragraph 1 of this Article.



Article 48

Derogation by the Member States from the requirements of Article 45(2) and obligations of the Member States regarding the means of identification


1.   By way of derogation from Article 45(2)(b), Member States may authorise operators keeping ovine or caprine animals to replace the means of identification listed in points (c) to (f) of Annex III, by a conventional ear tag or a conventional pastern band as listed in points (a) or (b) of that Annex subject to compliance with the following conditions:






(a)


the total number of ovine and caprine animals kept within its territory does not exceed 600 000 as recorded in a computer database;




and






(b)


the kept ovine and caprine animals are not intended to be moved to another Member State.






2.   By way of derogation from Article 45(2)(b), Member States may authorise operators keeping caprine animals to replace the means of identification listed in points (c) to (f) of Annex III, by a conventional ear tag or a conventional pastern band as listed in in points (a) or (b) of that Annex subject to compliance with the following conditions:






(a)


the total number of caprine animals kept within its territory does not exceed 160 000 as recorded in a computer database;




and






(b)


the kept caprine animals are not intended to be moved to another Member State.






3.   Member State shall ensure that the means of identification listed in points (a) to (f) of Annex III comply with the following requirements:






(a)


they display the identification code of the animal;










(b)


they are approved by the competent authority of the Member State where the ovine or caprine animals are kept.






4.   Member States shall establish procedures for application by:






(a)


manufacturers for approval of means of identification for ovine and caprine animals kept in their territory;










(b)


operators for the means of identification for ovine and caprine animals to be allocated to their establishment.









CHAPTER 2




Computer database




Article 49

Rules for information in computer database of kept ovine and caprine animals

The competent authority shall store the information referred to in Article 109(1)(b) of Regulation (EU) 2016/429 in respect of kept ovine and caprine animals in a computer database in accordance with the following rules:






(a)


the following information must be recorded for establishments keeping those animals:






(i)


the unique registration number assigned to it;










(ii)


the name and address of the operator of establishment;














(b)


the following information must be recorded for each movement of those animals into and from the establishment:






(i)


the total number of animals;










(ii)


the unique registration number of their establishments of origin and destination;










(iii)


the date of arrival;










(iv)


the date of departure.












CHAPTER 3




Movement document




Article 50

Movement document of kept ovine and caprine animals to be moved within the territory of a Member State

Movement document, as provided for in Article 113(1)(b) of Regulation (EU) 2016/429, for kept ovine and caprine animals to be moved within the territory of single Member State shall contain the following information:






(a)


the individual identification code of the animal or the unique registration number of the establishment of birth of the animal as displayed by the means of identification;










(b)


the type of electronic identifier, listed out in points (c) to (f) of Annex III, and its location, if applied to the animal;










(c)


the information provided for in Article 49(a)(i) and Article 49(b)(i), (ii) and (iv);










(d)


the unique registration number of the transporter;










(e)


the licence plate number or registration number of the means of transport.






Article 51

Derogation from certain requirements of Article 50 for movement document of kept ovine and caprine animals intended to be assembled within the territory of a Member State

The competent authority may grant derogations from the requirements in Article 50(a) for operators of establishments from which kept ovine and caprine animals are to be moved to an establishment where they are intended to be assembled, provided the following conditions are fulfilled:






(a)


the operators must not transport the kept ovine and caprine animals in the same means of transport as animals from other establishments, unless the batches of those animals are kept physically separated from each other in the means of transport;










(b)


the operators of establishments where the animals are to be assembled shall, subject to a permission by the competent authority, record the individual identification code of each animal as referred to in Article 50(a) on behalf of the operator of establishment from where ovine and caprine animals are received and such records are kept by that operator;










(c)


the competent authority must have granted access to the computer database referred to in Article 49 to the operators of establishments where assembly operations are to be conducted for the ovine and caprine animals;










(d)


the operators of establishments where the animals are to be assembled must have in place procedures to ensure that the information referred to in point (b) is recorded in the computer database referred to in Article 49.








TITLE III


TRACEABILITY OF KEPT PORCINE ANIMALS




CHAPTER 1




Means and methods of identification




Article 52

Obligations on operators keeping porcine animals as regards the means and methods of identification of kept porcine animals, their application and use


1.   Operators of establishments keeping porcine animals shall ensure that each porcine animal is identified by the following means of identification:






(a)


a conventional ear tag as listed in point (a) of Annex III or an electronic ear tag as listed in point (c) of Annex III, attached to an ear flap of the animal with a visible, legible and indelible display of the unique registration number of






(i)


the establishment of birth of animal;




or






(ii)


the last establishment of the supply chain referred to in Article 53 when those animals are moved to an establishment outside of that supply chain;








or






(b)


a tattoo as listed in point (g) of Annex III applied to an animal with indelible display of the unique registration number of






(i)


the establishment of birth of animal;




or






(ii)


the last establishment of the supply chain referred to in Article 53 when those animals are moved to an establishment outside of that supply chain.










2.   Operators of establishments keeping porcine animals shall ensure that:






(a)


the means of identifications are applied to porcine animals on:






(i)


the establishment of birth;




or






(ii)


the last establishment of the supply chain referred to in Article 53 when those animals are moved to an establishment outside of that supply chain;














b)


no means of identification are removed, modified or replaced without the permission of the competent authority.






3.   Operators of establishments keeping porcine animals may replace the means of identification referred to in paragraph 1 of this Article by an electronic identifier approved by the competent authority of the Member State where the porcine animals are kept in accordance with the exemptions provided for in Article 54(1).



Article 53

Derogations from the requirements of Article 52 as regards the means and methods of identification of kept porcine animals of the supply chain

By way of derogation from Article 52, the competent authority may allow the operators of establishments of the supply chain to derogate from the obligation to identify porcine animals when those animals are intended to be moved within that supply chain within its Member State territory provided that the practical application of traceability measures in that Member State ensures the full traceability of those animals.


Article 54

Exemptions granted by the competent authority for operators of confined establishments and for operators to identify porcine animals kept for cultural, recreational or scientific purposes


1.   The competent authority may exempt operators of confined establishments and operators keeping porcine animals for cultural, recreational or scientific purposes from the identification requirements for porcine animals provided for in Article 52(1).


2.   When granting exemptions as provided for in paragraph 1 of this Article, the competent authority shall ensure that an injectable transponder as listed in point (e) of Annex III, has been authorised by it for the identifications of porcine animals referred to in paragraph 1 of this Article, and that such authorised means of identification complies with the requirements of Article 55(1).


3.   The competent authority shall establish procedures for application by operators when requesting such an exemption as provided in paragraph 1 of this Article.



Article 55

Member States obligations as regards the means and methods of identification of kept porcine animals, their application and use


1.   Member States shall ensure that the means of identification listed in points (a), (c), (e) and (g) of Annex III comply with the following requirements:






(a)


they display either:






(i)


the unique registration number of the establishment of birth of the animal;




or






(ii)


in the case of animals that are to be moved from the establishment of a supply chain referred to in Article 53 to another establishment outside of that supply chain, the unique registration number of the last establishment of a supply chain;














(b)


they are approved by the competent authority of the Member State where porcine animals are kept.






2.   Member States shall establish procedures for application by:






(a)


manufacturers for approval of the means of identification for porcine animals kept in their territory;










(b)


operators for the means of identification for porcine animals to be allocated to their establishment.






3.   Member States shall establish and make available to the public of the list of establishments of the supply chain referred to in Article 53 in their territory.





CHAPTER 2




Computer database




Article 56

Rules for information in computer database of kept porcine animals

The competent authority shall store the information referred to in Article 109(1)(c) of Regulation (EU) 2016/429 in respect of kept porcine animals in a computer database in accordance with the following rules:






(a)


the following information must be recorded for establishments keeping those animals:






(i)


the unique registration number assigned it;










(ii)


the name and address of the operator of establishment;














(b)


the following information must be recorded for each movement of those animals into and from the establishment:






(i)


the total number of animals;










(ii)


the unique registration number of their establishments of origin and destination;










(iii)


the date of arrival;










(iv)


the date of departure.












CHAPTER 3




Movement document




Article 57

Movement documents of kept porcine animals to be moved within its Member State territory

Movement documents as provided for in Article 115(b) of Regulation (EU) 2016/429 for kept animals of the porcine species to be moved within the territory of a single Member State shall contain the following information:






(a)


the information to be kept in the computer database as referred to in Article 56(a)(i) and Article 56(b)(i), (ii) and (iv);










(b)


the unique registration number of the transporter;










(c)


the licence plate number or registration number of the means of transport.








TITLE IV


TRACEABILITY OF KEPT EQUINE ANIMALS




CHAPTER 1




Means and methods of identification




Article 58

Obligations on operators keeping equine animals as regards the means and methods of identification of those animals, their application and use


1.   Operators of kept equine animals shall ensure that each animal is individually identified by the following means of identification:






(a)


an injectable transponder as listed in point (e) of Annex III;










(b)


a single lifetime identification document.






2.   Operators of kept equine animals shall ensure that:






(a)


equine animals are identified within the time periods provided for in Article 12(1) and (2) of Regulation (EU) 2015/262;










(b)


no means of identification referred to in paragraph 1 are removed, modified or replaced without the permission of the competent authority of the establishment where those animals are habitually kept.






3.   Operators of kept equine animals, and if such operators are not the owner of the animals, acting on behalf of and in agreement with the owner of the animal, shall submit an application for the issuing of a single lifetime identification document, referred to in Article 65 or 66, to the competent authority of the establishment where the animals are habitually kept, and shall provide the competent authority with the necessary information to complete that identification document and the records in the database referred to in Article 64.



Article 59

Member States obligations for means and methods of identification of kept equine animals, their application and use


1.   Member States may authorise the injectable transponder referred to in Article 58(1)(a) to be replaced by:






(a)


a single conventional ear tag as listed in point (a) of Annex III applied to equine animals kept for meat production, provided that those animals were either born in that Member State or imported into that Member State without bearing a physical means of identification prior to entry into the Union;










(b)


an alternative method authorised by the competent authority in accordance with Article 62, which establishes an unequivocal link between the equine animal and the single lifetime identification document referred to in Article 58(1)(b).






2.   Member States shall ensure that the means of identification referred to in Article 58(1)(a) and in paragraph 1(a) of this Article comply with the following requirements:






(a)


they display the identification code of the animal;










(b)


they are approved by the competent authority of the Member State where the equine animals are identified in accordance with Article 58(2)(a).






3.   Member States shall:






(a)


establish procedures for application by manufacturers for approval of means of identification for kept equine animals identified in their territory;










(b)


establish deadlines for submission of the applications for the issuing of identification document provided for in Article 58(1)(b).







Article 60

Derogations for the identification of kept equine animals living under semi-wild conditions


1.   By way of derogation from Article 58(2)(a), Member States may specify populations of kept equine animals living under semi-wild conditions in certain areas of their territory, which shall only be required to be identified in accordance with Article 58(1) when they are:






(a)


removed from such populations, excluding their transfer under official supervision from one specified population to another;




or






(b)


brought into captivity for domestic use.






2.   Prior to making use of the derogation provided for in paragraph 1, Member States shall notify the Commission of the populations of equine animals and the areas where those animals live under semi-wild conditions.


3.   By way of derogation from Article 58(1), Member States may authorise the application of an injectable transponder as listed in point (e) of Annex III more than 12 months prior to the issuing of an identification document in accordance with paragraph 1 of this Article, provided that the identification code of the animal displayed on the injectable transponder is recorded by the operator at the time of implantation of the injectable transponder and transmitted to the competent authority.



Article 61

Derogations for the identification of kept equine animals moved to a slaughterhouse or accompanied by a temporary identification document


1.   By way of derogation from Article 58(2)(a), the competent authority may authorise the use of a simplified method of identification of equine animals intended to be moved to the slaughterhouse for which no single lifetime identification document was issued in accordance with Article 67(1), provided that






(a)


the equine animals are less than 12 months old;










(b)


there is an uninterrupted line of traceability of the animals from the establishment of birth to the slaughterhouse situated in the same Member State.




The equine animals must be transported directly to the slaughterhouse and during that transport they must be individually identified by injectable transponder, conventional or electronic ear tag, or conventional or electronic pastern band as listed in points (a), (b), (c), (e) or (f) of Annex III respectively.


2.   By way of derogation from Article 58(2)(a), the competent authority shall, on request by the operator of the equine animal, issue a temporary identification document for the period of time when the identification document issued in accordance with Article 67(1) is surrendered to that competent authority in order to update identification details in that document.



Article 62

Authorisation of alternative methods of identification of kept equine animals


1.   Member States may authorise suitable alternative methods of identification of kept equine animals, including the recording of marks, which ensure an unequivocal link between the equine animal and the single lifetime identification document and show that the equine animal has undergone the process of identification.


2.   Member States authorising alternative methods of identification as provided for in paragraph 1shall ensure that:






(a)


the alternative methods of identification are only used in exceptional cases for the identification of equine animals entered in specific breeding books or are used for specific purposes, or in case of equine animals which cannot be identified by an injectable transponder for medical or animal welfare reasons;










(b)


any authorised alternative method of identification or any combination of those methods provide at least the same guarantees as the injectable transponder;










(c)


the format of the information on the alternative method of identification applied to an equine animal must be suitable for entry in a searchable database.







Article 63

Obligation on operators using the alternative methods of identification


1.   Operators making use of an authorised alternative method of identification, as provided for in Article 62(1), shall provide to the competent authority and where necessary to other operators the means of accessing that identification information or have the onus of verifying the identity of the equine animal by those authorities or operators.


2.   Where alternative methods of identification are based on characteristics of the equine animal which may change over time, the operator shall provide the necessary information to the competent authority for them to update the identification document referred to in Article 62 and the database referred to in Article 64.


3.   Breed societies and international associations or organisations which manage horses for competition or races may require that equine animals which were identified by use of an alternative method of identification provided for in Article 62 are to be identified by implantation of an injectable transponder for the purpose of the entry or registration of purebred breeding animals of the equine species in breeding books or the registration of horses for competition or race purposes.





CHAPTER 2




Computer database




Article 64

Rules for information in computer database of kept equine animals

The competent authority shall store the information referred to in Article 109(1)(d) of Regulation (EU) 2016/429 in respect of kept equine animals in a computer database in accordance with the following rules:






(a)


for the establishment where those equine animals are habitually kept must be recorded:






(i)


the unique registration number assigned to it;










(ii)


the name and address of the operator of establishment;














(b)


for each equine animal habitually kept on the establishment must be recorded:






(i)


the unique code;










(ii)


where available, the identification code of the animal displayed by a physical means of identification;










(iii)


where the injected transponder has not been approved by the competent authority of the Member State where the equine animal was identified in accordance with Article 58(2), the reading system of that injected transponder;










(iv)


any information concerning new, duplicate or replacement identification documents issued for the animal;










(v)


the species of the animal;










(vi)


the sex of the animals, with a possibility to enter the date of gelding;










(vii)


the date and country of birth as declared by the operator of the kept equine animal;










(viii)


the date of natural death on the establishment or loss as declared by the operator of the kept equine animal, or the date of slaughter of that animal;










(ix)


the name and address of the competent authority, or the issuing body to which the task was assigned, which has issued the identification document;










(x)


the date of issuance of the identification document.














(c)


for each equine animal kept on the establishment for a period exceeding 30 days, the unique code shall be recorded; however, except in the following cases:






(i)


for equine animals participating in competitions, races, shows, training and hauling for a period not exceeding 90 days;










(ii)


for male equine animals for breeding kept during the breeding season;










(iii)


for female equine animals for breeding kept for a period not exceeding 90 days.












CHAPTER 3




Identification document




Article 65

Single lifetime identification document of kept equine animals


1.   The single lifetime identification document shall contain at least the following information:






(a)


the identification code of the animal displayed by the injectable transponder or ear tag;










(b)


the unique code assigned to the animal for its lifetime which encodes






(i)


the computer database in which the competent authority or issuing body recorded the information necessary to issue the first single lifetime identification document referred to in Article 58(1)(b), and where necessary a replacement single lifetime identification document referred to in Article 69(2)(b);










(ii)


the numerical identification code of the individual equine animal in that database;














(c)


the species of the animal;










(d)


the sex of the animal, with the possibility to enter the date of gelding;










(e)


the date and country of birth as declared by the operator of the kept equine animal;










(f)


the name and address of the issuing competent authority, or the issuing body to which the task was assigned;










(g)


the date of issue of the single lifetime identification document;










(h)


where applicable, information on the replacement of the physical means of identification and the identification code of the animal displayed by that replaced physical means of identification;










(i)


where applicable,






(i)


the validation mark issued and included in the single lifetime identification document by the competent authority, or by the body to which this activity was delegated, for a period not exceeding 4 years, which documents that the animal is habitually resident in an establishment recognised by the competent authority as an establishment with a low health risk due to frequent animal health visits, additional identity checks and health testing and the absence of natural breeding on the establishment, except in dedicated and separated premises, with the possibility of renewal of the validity period of issued valditation mark;




or






(ii)


the licence issued and included in the single lifetime identification document for a period not exceeding 4 years for participation in equestrian competitions by the national federation of the Federation Equestre Internationale or for participation in races by the competent racing authority and which documents at least two visits per year by a veterinarian, including those necessary to carry out regular equine influenza vaccination and examinations required for movements to other Member States or third countries, with the possibility of renewal of the validity period of issued licence.










2.   Single lifetime identification documents for registered equine animals and for equidae identified in accordance with Article 62 shall, in addition to the information referred to in paragraph 1 of this Article, contain at least the following information:






(a)


a pictorial and a verbal description of the animal, including the possibility to update this information;










(b)


where applicable, detailed information on alternative methods of identification;










(c)


where applicable, information on the breed in accordance with Annex of Delegated Regulation (EU) 2017/1940;










(d)


where applicable, information necessary for the use of the single lifetime identification document for sporting purposes in accordance with the requirements of the relevant organisations managing horses for competition or races, including information on tests for and vaccinations against listed or not-listed diseases as required for access to competitions and races and to obtain the licence referred to in paragraph 1(i)(ii).







Article 66

Obligations on operators of kept equine animals as regards the single lifetime identification documents


1.   Operators of kept equine animals shall ensure that those animals are at all times accompanied by their single lifetime identification document.


2.   By way of derogation from paragraph 1, operators shall not be required to ensure that kept equine animals are accompanied by their single lifetime identification document when those animals are:






(a)


stabled or on pasture, and the single lifetime identification document can be presented without delay by the operator of the kept equine animal or the operator of the establishment on which the animal is kept;










(b)


temporarily ridden, driven, led or taken either:






(i)


in the vicinity of the establishment on which the animal is kept within a Member State;




or






(ii)


during transhumance of animals to and from registered summer grazing grounds provided that the single lifetime identification documents can be presented at the establishment of departure;














(c)


unweaned equine animals and accompanying their dam or foster mare;










(d)


participating in a training or test of an equestrian competition, race or event which requires them to leave temporarily the establishement on which the training, competition, race or event takes place;










(e)


moved or transported in an emergency situation relating to the animals themselves or to the establishment where they are kept.






3.   Operators of kept equine animals shall not move an equine animal accompanied by the temporary document referred to in Article 61(2) to the slaughterhouse.


4.   Operators of kept equine animals shall return the single lifetime identification document to the issuing competent authority, or the issuing body to which the task was delegated, as decoded from the unique code after the death or loss of the equine animal.



Article 67

Obligations on the competent authority as regards the issue of duplicate and replacement single lifetime identification documents


1.   On application by the operator, the competent authority, or the issuing body to which the task was assigned shall issue a duplicate single lifetime identification document where the identity of the kept equine animal can be established and the operator either






(a)


declared the loss of the single lifetime identification document issued in respect of the animal;




or






(b)


failed to identify the animal within the time periods provided for in Article 58(2)(a).






2.   On application by the operator or on its own initiative, the competent authority shall issue a replacement single identification document where the identity of the animal cannot be established and the operator either






(a)


declared the loss of the single lifetime identification document issued in respect of the animal;




or






(b)


failed to comply with the identification requirements of Article 58(2)(b).







Article 68

Obligations on the competent authority as regards the issue of new single lifetime documents for registered equine animal

Where an identified equine animal becomes a registered equine animal and the single lifetime identification document issued in respect of that animal cannot be adapted to meet the requirements laid down in Article 65(2), the competent authority, or the issuing body to which the task was assigned, on application of the operator of the equine animal, shall issue a new single lifetime identification document to replace the former one containing the information required in accordance with Article 65(1) and (2).


Article 69

Obligations on the competent authority as regards the concerning duplicate, replacement and new identification documents


1.   The competent authority, or the issuing body to which the task was assigned shall enter information concerning the issuing of a duplicate or replacement identification document in accordance with Article 67 or the issuing of a new identification document in accordance with Article 68 in the computer database referred to in Article 64.


2.   The competent authority, or the issuing body to which the task was assigned shall enter






(a)


in the duplicate single lifetime identification document and in the new single lifetime identification document, the unique code assigned to the animal in accordance with Article 65(1)(b) on the occasion of the issue of the first single lifetime identification document;




or






(b)


in the replacement single lifetime identification document, the unique code assigned to the equine animal on the occasion of its issue.









TITLE V


TRACEABILITY OF KEPT DOGS, CATS AND FERRETS, CAMELID AND CERVID ANIMALS, CAPTIVE BIRDS AND TERRESTRIAL ANIMALS IN TRAVELLING CIRCUSES AND ANIMAL ACTS




CHAPTER 1




Traceability of kept dogs, cats and ferrets





Section 1




Means of identification




Article 70

Obligations on operators keeping dogs, cats and ferrets as regards the means and methods of identification of those animals, their application and use

Operators keeping dogs, cats and ferrets shall ensure that:






(a)


those animals are individually identified by an injectable transponder as listed in point (e) of Annex III when they are moved to another Member State;










(b)


the injectable transponder intended for implantation in the animal is approved by the competent authority;










(c)


they provide to the competent authority and where necessary to other operators the reading device which enables at any time the verification of the individual identification of the animal where the implanted injectable transponder has not been approved by the competent authority.








Section 2




Identification document




Article 71

Identification document of kept dog, cats and ferrets

Operators keeping dogs, cats and ferrets shall ensure that each of those animals where it is moved to another Member State is accompanied by an identification document referred to in Article 6(d) of Regulation (EU) No 576/2013, duly completed and issued in accordance with Article 22 of that Regulation.




Section 3




Traceability of pet animals




Article 72

Traceability requirements for other than non-commercial movements of pet animals

Operators shall ensure that pet animals moved to another Member State for purposes other than non-commercial movement comply with the rules laid down in Articles 70 and 71.





CHAPTER 2




Traceability of kept camelid and cervid animals




Article 73

Obligations on operators keeping camelid and cervid animals as regards the means and methods of identification of those animals, their application and use


1.   Operators keeping camelid animals shall ensure that those animals are individually identified by either:






(a)


a conventional ear tag as listed in point (a) of Annex III attached to each ear flap of the animals with visible, legible and indelible display of the identification code of the animal;




or






(b)


an injectable transponder as listed in point (e) of Annex III with legible and indelible display of the identification code of the animal.






2.   Operators keeping cervid animals shall ensure that those animals are individually identified by one of the following means of identification:






(a)


a conventional ear tag as listed in point (a) of Annex III attached to each ear flap of the animals with visible, legible and indelible display of the identification code of the animal;




or






(b)


an injectable transponder as listed in point (e) of Annex III with legible and indelible display of the identification code of the animal;




or






(c)


a tattoo as listed in point (g) of Annex III applied to an animal with indelible display of the identification code of the animal.






3.   Operators of establishments keeping camelid and cervid animals shall ensure that:






(a)


the means of identification are applied to those animals on the establishment of birth;










(b)


no means of identification are removed, modified or replaced without the permission of the competent authority;










(c)


they provide to the competent authority and where necessary to other operators the reading device which enables at any time the verification of the individual identification of the animal where the implanted injectable transponder has not been approved by the competent authority.







Article 74

Exemption for operators keeping reindeer

By way of exemption from the requirements of Article 73(2), operators keeping reindeer shall ensure that those animals kept on their establishments are each identified by an alternative method authorised by the competent authority of Member State.


Article 75

Member States’ obligations for the means of identification of kept camelid and cervid animals


1.   Member States shall ensure that the means of identification listed in points (a), (e) and (g) of Annex III comply with the following requirements:






(a)


they display the identification code of the animal;










(b)


they are approved by the competent authority of the Member State where the camelid and cervid animals are kept.






2.   Member States shall establish procedures for the following:






(a)


application for approval by manufacturers of means of identification for camelid and cervid animals kept in their territory;










(b)


application by operators keeping camelid and cervid animals for the means of identification to be allocated to their establishment.









CHAPTER 3




Traceability of captive birds




Article 76

Obligations on operators keeping psittacidae as regards the means and methods of identification of those animals, their application and use


1.   Operators keeping psittacidae shall ensure that those animals are individually identified where they are moved to another Member State by one of the following means of identification:






(a)


a leg ring as listed in point (h) of Annex III attached at least to one leg of the animal with a visible, legible and indelible display of the identification code of the animal;




or






(b)


an injectable transponder as listed in point (e) of Annex III with legible and indelible display of the identification code of the animal;




or






(c)


a tattoo as listed in point (g) of Annex III applied to an animal with a visible and indelible display of the identification code of the animal.






2.   Operators keeping psittacidae shall:






(a)


ensure that the means of identification referred to in paragraph 1(b) is approved by the competent authority;










(b)


provide to the competent authority and where necessary to other operators the reading device which enables at any time the verification of the individual identification of the animal in case the means of identification referred to in paragraph 1(b) has not been approved by the competent authority.









CHAPTER 4




Traceability of kept terrestrial animals in travelling circuses and animal acts





Section 1




Movement and identification documents of kept terrestrial animals in travelling circuses and animal acts




Article 77

Obligations on competent authority as regards the movement document of kept terrestrial animals in travelling circuses and animal acts


1.   The competent authority shall issue a movement document as provided for in Article 117(b) of Regulation (EU) 2016/429 for all kept terrestrial animals in travelling circuses or animal acts intended to be moved to another Member State, except lagomorphs, rodents, honeybees and bumble bees.


2.   The competent authority shall ensure that the movement document provided for in paragraph 1 contains at least the following information:






(a)


the commercial name of the travelling circus or animal act;










(b)


the unique registration number of the travelling circus or animal act assigned by the competent authority;










(c)


the name and address of the operator of the travelling circus or animal act;










(d)


the species and quantity;










(e)


for each animal for which the operator of the travelling circus or animal act is not responsible, the name and address of the operator responsible for the animal or pet owner;










(f)


the identification code of the animal displayed by the means of identification provided for in Articles 38, 39, 45, 47, 52, 54, 58, 70, 73, 74 and 76;










(g)


the type of electronic identifier and its location, if applied to the animal as referred to in point (f);










(h)


the identification mark, means of identification and its location if applicable, for animals other than those referred to in point (f) applied by the operator;










(i)


the date of movement of each animal into and from the travelling circus or animal act;










(j)


the name, address and signature of the official veterinarian issuing the identification document;










(k)


the date of issue of the movement document.







Article 78

Obligations on the competent authority as regards the identification document of kept terrestrial animals in travelling circuses and animal acts


1.   The competent authority shall issue an identification document as provided for in Article 117(b) of Regulation (EU) 2016/429 for each kept terrestrial animal in travelling circuses or animal acts intended to be moved to another Member State, except for animals of the equine species, birds, dogs, cats and ferrets, lagomorphs and rodents.


2.   The competent authority shall ensure that the identification document provided for in paragraph 1 contains the following information:






(a)


the name, address and contact information of the operator responsible for the animal;










(b)


species, sex, colour, and any notable or discernible features or characteristics of the animal;










(c)


the identification code of the animal identified by the means of identification provided for in Articles 38, 39, 45, 47, 52, 54, 58, 70, 73, 74 and 76;










(d)


the type of electronic identifier and its location, if applied to the animal referred to in point (c);










(e)


the identification mark, means of identification and its location if applicable, for other animals than those referred to in point (c) applied by the operator;










(f)


details of the vaccination of the animal, if applicable;










(g)


details of the treatments of the animal, if applicable;










(h)


details of diagnostic tests;










(i)


the name and address of the competent authority issuing the identification document;










(j)


the date of issue of the identification document.







Article 79

Obligations on the competent authority as regards the identification document of kept birds in travelling circuses and animal acts


1.   The competent authority shall issue an identification document as provided for in Article 117(b) of Regulation (EU) 2016/429 for group of kept birds in travelling circuses or animal acts intended to be moved to another Member State.


2.   The competent authority shall ensure that the identification document provided for in paragraph 1 contains the following information:






(a)


the name, address and contact information of the operator responsible for the birds;










(b)


the species of the birds;










(c)


the identification code, the means of identification and its location if applied to the birds;










(d)


details of the vaccination of the birds, if applicable;










(e)


details of the treatments of the birds, if applicable;










(f)


details of diagnostic tests;










(g)


the name and address of the competent authority issuing the identification document;










(h)


the date of issue of the identification document.










TITLE VI


TRACEABILITY OF HATCHING EGGS



Article 80

Obligation on operators as regards the traceability of hatching eggs

Operators of establishments keeping poultry and operators of hatcheries shall ensure that each hatching egg is marked with the unique approval number of the establishment of origin of the hatching eggs.



TITLE VII


TRACEABILITY OF KEPT TERRESTRIAL ANIMALS AFTER THEIR ENTRY INTO UNION



Article 81

Obligations on operators as regards the means and methods of identification of kept bovine, ovine, caprine, porcine, cervid or camelid animals after their entry into the Union


1.   In case the means of identification have been applied to kept bovine, ovine, caprine, porcine, cervid or camelid animals in third countries or territories, after their entry into the Union and where they remain in the Union, operators of the establishments of the first arrival of those animals shall ensure that the animals are identified by the means of identification provided for in Articles 38, 39, 45, 47, 52, 54, 73 and 74, as appropriate.


2.   In case of kept bovine, ovine, caprine, porcine, cervid or camelid animals originating from Member States and identified in accordance with the Union rules, after their entry from third countries or territories into the Union and where they remain in the Union, operators of the establishments of the first arrival of those animals shall ensure that animals are identified by the means of identification provided for in 38, 39, 45, 47, 52, 54, 73 and 74, as appropriate.


3.   Operators shall not apply the rules referred to in paragraphs 1 and 2 to kept bovine, ovine, caprine, porcine, cervid or camelid animals intended to move to a slaughterhouse situated in a Member State, provided the animals are slaughtered within 5 days after their entry into Union.



Article 82

Member States’ obligations as regards the means and methods of identification of kept bovine, ovine, caprine, porcine, cervid or camelid animals after their entry into Union

Member States shall establish procedures for operators of establishments keeping animals referred to in Article 81(2) to follow when requesting the means of identification to be allocated to their establishment.


Article 83

Obligations on operators as regards the means and methods of identification of kept animals of the equine species after their entry into Union

Operators of kept animals of the equine species shall ensure that after the entry of equine animals into the Union and where they remain in the Union, they are identified in accordance with Article 58 after the date of completion of the customs procedure, as defined in Article 5(16)(a) of Regulation (EU) No 952/2013.




PART IV


TRANSITIONAL AND FINAL PROVISIONS



Article 84

Repeal

The following acts are repealed as from 21 April 2021:






—


Regulation (EC) No 509/1999,










—


Regulation (EC) No 2680/1999,










—


Decision 2000/678/EC,










—


Decision 2001/672/EC,










—


Regulation (EC) No 911/2004,










—


Decision 2004/764/EC,










—


Regulation (EC) No 644/2005,










—


Regulation (EC) No 1739/2005,










—


Decision 2006/28/EC,










—


Decision 2006/968/EC,










—


Decision 2009/712/EC,










—


Regulation (EU) 2015/262.




References to the repealed acts shall be construed as references to this Regulation.


Article 85

Transitional measures related to the repeal of Regulation (EC) No 1739/2005

Notwithstanding Article 84 of this Regulation, Article 5 and Article 7(1) and (2) of Regulation (EC) No 1739/2005 concerning the register of animals and animal passports and Annexes I, III and IV thereto shall remain applicable until a date to be determined by the Commission in an implementing act adopted in accordance with Article 120(2) of Regulation (EU) 2016/429.


Article 86

Transitional measures related to the repeal of Regulation (EU) 2015/262

Notwithstanding Article 84 of this Regulation:






(a)


the deadlines for the identification of equidae born in the Union provided for in Article 12(1) and (2) of Regulation (EU) 2015/262 shall remain applicable until a date to be determined by the Commission in an implementing act adopted in accordance with Article 120(2) of Regulation (EU) 2016/429;










(b)


the rules on equidae intended for slaughter for human consumption and medication records provided for in Article 37 of Regulation (EU) 2015/262 shall remain applicable until a date to be determined by the Commission in a delegated act adopted in accordance with Article 109(1) of Regulation (EU) 2019/6;










(c)


the rules on the format and content of identification documents issued for equidae born in the Union provided for in Annex I to Regulation (EU) 2015/262 shall remain applicable until a date to be determined by the Commission in an implementing act adopted in accordance with Article 120(2) of Regulation (EU) 2016/429.






Article 87

Transitional measures regarding identification of kept terrestrial animals


1.   Articles 1 to 10 of Regulation (EC) No 1760/2000, Regulation (EC) No 21/2004, and Directive 2008/71/EC, as well as the acts adopted on the basis thereof, shall continue to apply until 21 April 2021.


2.   Kept bovine, ovine, caprine and porcine animals that have been identified before 21 April 2021 in accordance with Regulation (EC) No 1760/2000, Regulation (EC) No 21/2004 and Directive 2008/71/EC, as well as the acts adopted on the basis thereof, shall be considered to have been identified in accordance with this Regulation.


3.   Kept equine animals that have been identified before 21 April 2021 in accordance with Implementing Regulation (EU) 2015/262 shall be considered to have been identified in accordance with this Regulation.


4.   Kept camelid and cervid animals that have been identified before 21 April 2021 in accordance with applicable national law shall be considered to have been identified in accordance with this Regulation.


5.   Kept psittacidae that have been identified before 21 April 2021 in accordance with Directive 92/65/EEC shall be considered to have been identified in accordance with this Regulation.



Article 88

Transitional measures regarding the information in the registers kept by competent authorities

Member States shall ensure that information referred to in Articles 18 to 21 of this Regulation for existing establishments and operators referred to in Article 279(1) of Regulation (EU) 2016/429 has been included for each establishment and operator in the registers for them kept by competent authorities by 21 April 2021.


Article 89

Entry into force and application

This Regulation shall enter into force on the twentieth 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, 28 June 2019.


For the Commission


The President

Jean-Claude JUNCKER
            





(1)  
            OJ L 84, 31.3.2016, p. 1.

(2)  Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (OJ 121, 29.7.1964, p. 1977/64).

(3)  Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC (OJ L 268, 14.9.1992, p. 54).

(4)  Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (OJ L 343, 22.12.2009, p. 74).

(5)  Council Regulation (EC) No 1255/97 of 25 June 1997 concerning Community criteria for control posts and amending the route plan referred to in the Annex to Directive 91/628/EEC (OJ L 174, 2.7.1997, p. 1).

(6)  Commission Implementing Regulation (EU) No 139/2013 of 7 January 2013 laying down animal health conditions for imports of certain birds into the Union and the quarantine conditions thereof (OJ L 47, 20.2.2013, p. 1).

(7)  Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300, 14.11.2009, p. 1).

(8)  Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820/97 (OJ L 204, 11.8.2000, p. 1).

(9)  Council Regulation (EC) No 21/2004 of 17 December 2003 establishing a system for the identification and registration of ovine and caprine animals and amending Regulation (EC) No 1782/2003 and Directives 92/102/EEC and 64/432/EEC (OJ L 5, 9.1.2004, p. 8).

(10)  Council Directive 2008/71/EC of 15 July 2008 on the identification and registration of pigs (OJ L 213, 8.8.2008, p. 31).

(11)  Council Directive 2009/156/EC of 30 November 2009 on animal health conditions governing the movement and importation from third countries of equidae (OJ L 192, 23.7.2010, p. 1).

(12)  Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, p. 1).

(13)  Regulation (EU) No 576/2013 of the European Parliament and of the Council of 12 June 2013 on the non-commercial movement of pet animals and repealing Regulation (EC) No 998/2003 (OJ L 178, 28.6.2013, p. 1).

(14)  Commission Regulation (EC) No 1739/2005 of 21 October 2005 laying down animal health requirements for the movement of circus animals between Member States (OJ L 279, 22.10.2005, p. 47).

(15)  Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and groups of species posing a considerable risk for the spread of those listed diseases (OJ L 308, 4.12.2018, p. 21).

(16)  Directive 2001/82/EC of the European Parliament and of Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).

(17)  Commission Implementing Regulation (EU) 2015/262 of 17 February 2015 laying down rules pursuant to Council Directives 90/427/EEC and 2009/156/EC as regards the methods for the identification of equidae (Equine Passport Regulation) (OJ L 59, 3.3.2015, p. 1).

(18)  Regulation (EU) 2016/1012 of the European Parliament and of the Council of 8 June 2016 on zootechnical and genealogical conditions for the breeding, trade in and entry into the Union of purebred breeding animals, hybrid breeding pigs and the germinal products thereof and amending Regulation (EU) No 652/2014, Council Directives 89/608/EEC and 90/425/EEC and repealing certain acts in the area of animal breeding (‘Animal Breeding Regulation’) (OJ L 171, 29.6.2016, p. 66).

(19)  Commission Delegated Regulation (EU) 2017/1940 of 13 July 2017 supplementing Regulation (EU) 2016/1012 of the European Parliament and of the Council as regards the content and format of zootechnical certificates issued for purebred breeding animals of the equine species contained in a single lifetime identification document for equidae (OJ L 275, 25.10.2017, p. 1).

(20)  Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43).

(21)  Commission Regulation (EC) No 509/1999 of 8 March 1999 concerning an extension of the maximum period laid down for the application of ear-tags to bison (Bison bison spp.) (OJ L 60, 9.3.1999, p. 53).

(22)  Commission Regulation (EC) No 2680/1999 of 17 December 1999 approving a system of identification for bulls intended for cultural and sporting events (OJ L 326, 18.12.1999, p. 16).

(23)  Commission Decision 2000/678/EC of 23 October 2000 laying down detailed rules for registration of holdings in national databases for porcine animals as foreseen by Council Directive 64/432/EEC (OJ L 281, 7.11.2000, p. 16).

(24)  Commission Decision 2001/672/EC of 20 August 2001 laying down special rules applicable to movements of bovine animals when put out to summer grazing in mountain areas (OJ L 235, 4.9.2001, p. 23).

(25)  Commission Regulation (EC) No 911/2004 of 29 April 2004 implementing Regulation (EC) No 1760/2000 of the European Parliament and of the Council as regards eartags, passports and holding registers (OJ L 163, 30.4.2004, p. 65).

(26)  Commission Decision 2004/764/EC of 22 October 2004 concerning an extension of the maximum period laid down for the application of eartags to certain bovine animals kept in nature reserves in the Netherlands (OJ L 339, 16.11.2004, p. 9).

(27)  Commission Regulation (EC) No 644/2005 of 27 April 2005 authorising a special identification system for bovine animals kept for cultural and historical purposes on approved premises as provided for in Regulation (EC) No 1760/2000 of the European Parliament and of the Council (OJ L 107, 28.4.2005, p. 18).

(28)  Commission Decision 2006/28/EC of 18 January 2006 on extension of the maximum period for applying eartags to certain bovine animals (OJ L 19, 24.1.2006, p. 32).

(29)  Commission Decision 2006/968/EC of 15 December 2006 implementing Council Regulation (EC) No 21/2004 as regards guidelines and procedures for the electronic identification of ovine and caprine animals (OJ L 401, 30.12.2006, p. 41).

(30)  Commission Decision 2009/712/EC of 18 September 2009 implementing Council Directive 2008/73/EC as regards internet-based information pages containing lists of establishments and laboratories approved by Member States in accordance with Community veterinary and zootechnical legislation (OJ L 247, 19.9.2009, p. 13).




ANNEX I

REQUIREMENTS FOR GRANTING APPROVAL OF ESTABLISHMENTS AS REFERRED TO IN CHAPTERS 2, 3 AND 4 OF TITLE I OF PART II

PART 1

Requirements for granting approval of establishments for assembly operations of ungulates referred to in Article 5









1.


The requirements in relation to isolation and biosecurity measures of establishments for assembly operations of ungulates, as referred to in Article 5, shall be the following:






(a)


appropriate isolation facilities for the ungulates must be available;










(b)


at any given time, the establishment must only accommodate the same category of ungulates of the same species and health status;










(c)


an appropriate system must be in place to ensure the collection of waste water;










(d)


the areas where the ungulates are kept and any passageways, and material and equipment that comes into contact with them must be cleaned and disinfected after the removal of each batch of ungulates, and where necessary before the introduction of any new batch of ungulates, in accordance with established operational procedures;










(e)


appropriate sanitary breaks must be taken after the cleaning and disinfecting operations and prior to the arrival of any new batch of ungulates in the facilities where ungulates are kept.
















2.


The requirements in relation to facilities and equipment of establishments for assembly operations of ungulates, as referred to in Article 5, shall be the following:






(a)


suitable equipment and facilities must be available for the purpose of loading and unloading ungulates;










(b)


adequate housing of a suitable standard for the ungulates must be available and constructed in such a way that contact with livestock outside and direct communication with isolation accommodation are prevented, and that inspection and any necessary treatment can be easily carried out;










(c)


an appropriate storage area must be available for bedding material, fodder, litter and manure;










(d)


the areas where those animals are kept and the passageways, floors, walls, ramps and all other material or equipment that comes into contact with them can be readily cleaned and disinfected;










(e)


appropriate equipment must be available for the cleaning and disinfection of facilities, equipment and means of transport used for the ungulates.
















3.


The requirements in relation to the personnel of establishments for assembly operations of ungulates, as referred to in Article 5, shall be the following:






(a)


they must possess the appropriate ability and knowledge, and have received specific training, or have acquired the equivalent practical experience in:






(i)


the handling of, and if necessary the administration of appropriate care to, the ungulates kept on the establishment;










(ii)


the disinfection and hygiene techniques needed to prevent the spread of transmissible diseases.




















4.


The requirements in relation to the supervision by the competent authority of establishments for assembly operations of ungulates, as referred to in Article 5, shall be the following:






(a)


the operator must provide the official veterinarian with the possibility to use an office for






(i)


supervising the assembly operations of ungulates;










(ii)


inspecting the establishment for compliance with the requirements laid down in points 1, 2 and 3;










(iii)


providing animal health certification of ungulates;














(b)


the operator must ensure that assistance is provided on request from the official veterinarian to carry out the supervision duties referred to in 4(a)(i).








PART 2

Requirements for granting approval of establishments for assembly operations of poultry referred to in Article 6









1.


The requirements in relation to the isolation and other biosecurity measures of establishments for assembly operations of poultry, as referred to in Article 6, shall be the following:






(a)


appropriate isolation facilities for the poultry must be available;










(b)


at any given time the establishment must only accommodate the same category of poultry of the same species and health status;










(c)


an appropriate system must be in place to ensure the collection of waste water;










(d)


the areas where the poultry are kept and any passageways, and the material and equipment that comes into contact with them must be cleaned and disinfected after the removal of each batch of poultry, and where necessary before the introduction of any new batch of poultry, in accordance with established operational procedures;










(e)


appropriate sanitary breaks must be taken after the cleaning and disinfecting operations and prior to the arrival of any new batch of poultry in the facilities where poultry are kept;










(f)


visitors must wear protective clothing and the personnel must wear appropriate working clothing and act in accordance with the hygiene rules drawn up by the operator.
















2.


The requirements in relation to facilities and equipment of establishments for assembly operations of poultry, as referred to in Article 6, shall be the following:






(a)


the establishment must only house poultry;










(b)


an appropriate storage area must be available for bedding material, feed, litter and manure;










(c)


the poultry must not come into contact with rodents and with birds coming from outside the establishment;










(d)


the areas where those animals are kept and the passageways, floors, walls, ramps and all other material or equipment that comes into contact with them must be readily cleaned and disinfected;










(e)


appropriate equipment must be available for the cleaning and disinfection of facilities, equipment and means of transport used for the poultry;










(f)


the establishment must have good conditions of hygiene and allow health monitoring to be carried out.
















3.


The requirements in relation to the personnel of establishments for assembly operations of poultry, as referred to in Article 6, shall be the following:






(a)


they possess the appropriate ability and knowledge, and have received specific training, or have acquired the equivalent practical experience in:






(i)


the handling of, and if necessary the administration of appropriate care to, the poultry kept on the establishment;










(ii)


the disinfection and hygiene techniques needed to prevent the spread of transmissible diseases.




















4.


The requirements in relation to supervision by the competent authority of establishments for assembly operations of poultry, as referred to in Article 6, shall be the following:






(a)


the operator must provide the official veterinarian with the possibility to use an office for:






(i)


supervising the assembly operations of poultry;










(ii)


inspecting the establishment for compliance with the requirements laid down in points 1, 2 and 3;










(iii)


providing animal health certification of poultry;














(b)


the operator must ensure that assistance is provided on request from the official veterinarian to carry out the supervision duties referred to in 4(a)(i).








PART 3

Requirements for granting approval of hatcheries referred to in Article 7









1.


The requirements in relation to biosecurity measures of hatcheries, as referred to in Article 7, shall be the following:






(a)


hatching eggs of poultry must come either from approved establishments keeping breeding poultry or from other approved hatcheries of poultry;










(b)


eggs must be cleaned and disinfected, between the time of their arrival at the hatchery and the incubation process or at the time of their dispatch unless they have been previously disinfected on the establishment of origin;










(c)


the following must be cleaned and disinfected:






(i)


the incubators and equipment after hatching;










(ii)


the packaging materials after each use, unless they are disposable to be destroyed after first use;














(d)


an appropriate system must be in place to ensure the collection of waste water;










(e)


protective clothing is provided for visitors working;










(f)


appropriate working clothing and the code of conduct with hygiene rules must be provided to personnel.
















2.


The requirements in relation to the surveillance of hatcheries, as referred to in Article 7, shall be the following:






(a)


the operator must implement a microbiological quality control programme in accordance with Part 1 of Annex II;










(b)


the operator of the hatchery must ensure that arrangements are in place with the operator of the establishment keeping the poultry, where the hatching eggs are originating for sampling to be carried in the hatchery for testing for the disease agents referred to in the disease surveillance programme referred to in Part 2 of Annex II, in order to complete that programme.
















3.


The requirements in relation to the facilities and equipment of hatcheries, as referred to in Article 7, shall be the following:






(a)


hatcheries must be physically and operationally separated from facilities keeping poultry or any other birds;










(b)


the following functional units and equipment must be kept separate:






(i)


egg storage and grading;










(ii)


egg disinfection;










(iii)


pre-incubation;










(iv)


incubation for hatching;










(v)


sexing and vaccination of day-old chicks;










(vi)


packaging of hatching eggs and day-old chicks for dispatch;














(c)


day-old chicks or hatching eggs kept at the hatchery must not come into contact with rodents and with birds outside the hatchery;










(d)


operations must be based on a one-way circuit for hatching eggs, mobile equipment and personnel;










(e)


appropriate natural or artificial lighting, air flow and temperature systems must be available;










(f)


it must be possibly to readily clean and disinfect the floors, walls and all other material or equipment at the hatchery;










(g)


appropriate equipment must be available for the cleaning and disinfection of facilities, equipment and means of transport used for the day-old chicks and hatching eggs.
















4.


The requirements in relation to the personnel in contact with hatching eggs and day-old chicks, as referred to in Article 7, shall be the following:






(a)


the personnel must possess the appropriate ability and knowledge, and have for that purpose received specific training, or have acquired the equivalent practical experience in the disinfection and hygiene techniques needed to prevent the spread of transmissible diseases.
















5.


The requirements in relation to supervision by the competent authority of hatcheries, as referred to in Article 7, shall be the following:






(a)


the operator must provide the official veterinarian with the possibility to use an office for






(i)


inspecting the hatchery for compliance with the requirements laid down in points 1 to 4;










(ii)


providing animal health certification of hatching eggs and day-old chicks;














(b)


the operator must ensure that assistance is provided on request from the official veterinarian to carry out the supervision duties referred to in 5(a)(i).








PART 4

Requirements for granting approval of establishments keeping poultry referred to in Article 8









1.


The requirements in relation to biosecurity measures of establishments keeping poultry, as referred to in Article 8, shall be the following:






(a)


the hatching eggs must be:






(i)


collected at frequent intervals, at least daily and as soon as possible after laying;










(ii)


cleaned and disinfected as soon as possible, unless disinfection takes place at a hatchery in the same Member State;










(iii)


placed either in new or in cleaned and disinfected packaging material;














(b)


if an establishment houses poultry species of the orders Galliformes and Anseriformes at the same time, a clear separation must be made between them;










(c)


appropriate sanitary breaks must be taken after the cleaning and disinfecting operations and prior to the arrival of any new flock of poultry in the facilities where poultry is kept;










(d)


visitors must wear protective clothing and the personnel must wear appropriate working clothing and act in accordance with the hygiene rules drawn up by the operator;










(e)


an appropriate system must be in place to ensure the collection of waste water.
















2.


The requirements in relation to surveillance of establishments keeping poultry, as referred to in Article 8, shall be the following:






(a)


the operator must apply and adhere to a disease surveillance programme referred to in Part 2 of Annex II;










(b)


the operator of the establishment must ensure that arrangements are in place with the operator of the hatchery where the hatching eggs are destined for sampling to be carried in the hatchery for testing for the disease agents referred to in the disease surveillance programme referred to in Part 2 of Annex II, in order to complete of that programme.
















3.


The requirements in relation to the facilities and equipment of establishments keeping poultry, as referred to in Article 8, shall be the following:






(a)


the setting and layout must be compatible with the type of production pursued;










(b)


the establishment must house only poultry:






(i)


from the establishment itself;




or






(ii)


from other approved establishments keeping poultry;




or






(iii)


from approved hatcheries of poultry;




or






(iv)


which entered into the Union from authorised third countries and territories;














(c)


the poultry must be prevented from coming into contact with rodents and with birds coming from outside;










(d)


the facilities must provide good conditions of hygiene and allow health monitoring to be carried out;










(e)


it must be possibly to readily clean and disinfect the floors, walls and all other material or equipment at the establishment;










(f)


the establishment must have appropriate equipment, compatible with the type of production pursued, which is available for the cleaning and disinfection of facilities, equipment and means of transport at the most suitable spot in the establishment.








PART 5

Requirements for granting approval of assembly centres of dogs, cats and ferrets and of animal shelters for those animals referred to respectively in Articles 10 and 11









1.


The requirements in relation to isolation and other biosecurity measures of assembly centres of dogs, cats and ferrets, as referred to in Article 10, shall be the following:






(a)


they must only admit dogs, cats and ferrets coming from registered establishments keeping those animals;










(b)


appropriate isolation facilities for the dogs, cats and ferrets must be available;










(c)


appropriate sanitary breaks must be taken after the cleaning and disinfecting operations and prior to the arrival of any new batch of dogs, cats and ferrets in the facilities keeping such animals;










(d)


appropriate system must be in place to ensure the collection of waste water.
















2.


The requirements in relation to isolation and other biosecurity measures of animal shelters for dogs, cats and ferrets, as referred to in Article 11, shall be the following:






(a)


appropriate isolation facilities for the dogs, cats and ferrets must be available;










(b)


the areas where the cats, dogs and ferrets are kept and any passageways, and material and equipment that comes into contact with them must be cleaned and disinfected after the removal of each batch of those animals, and where necessary before the introduction of any new batch of such animals, in accordance with established operational procedures;










(c)


appropriate sanitary breaks must be taken after the cleaning and disinfecting operations and prior to the arrival of any new batch of dogs, cats and ferrets in the facilities where those animals are kept;










(d)


appropriate system must be in place to ensure the collection of waste water.
















3.


The requirements in relation to facilities and equipment of assembly centres of dogs, cats and ferrets, and animal shelters for those animals, as referred to respectively in Articles 10 and 11, shall be the following:






(a)


adequate housing of a suitable standard for those animals must be available and must be constructed in such a way that contact with animals from the outside is prevented and there is no direct communication with the isolation accommodation, and inspections and any necessary treatments can be easily carried out;










(b)


the areas where those animals are kept and any passageways, floors, walls and all other material or equipment that comes into contact with them can be readily cleaned and disinfected;










(c)


appropriate storage areas must be available respectively for bedding material, litter, manure and petfood;










(d)


appropriate equipment must be available for the cleaning and disinfection of facilities, implements and means of transport.








PART 6

Requirements for granting approval of control posts referred to in Article 12









1.


The requirements in relation to isolation and other biosecurity measures of control posts, as referred to in Article 12, shall be the following:






(a)


control posts must be located, designed, constructed and operated in such a way as to ensure sufficient biosecurity to prevent the spread of listed or emerging diseases to other establishments and between consecutive consignments of animals passing through these premises;










(b)


control post must be constructed, equipped and operated in such a way as to ensure that cleaning and disinfection procedures can be readily carried out; a means of transport wash must be provided on-the-spot;










(c)


control posts must have suitable facilities for the separate isolation of animals suspected of being infected with an animal disease;










(d)


appropriate sanitary breaks must be taken between two consecutive consignments of animals and if appropriate adapted depending on whether the animals come from a similar region, zone or compartment with the same health status; in particular, there must be no animals present in the control posts for a period of at least 24 hours after a maximum period of 6 days’ use and after cleansing and disinfecting operations have been completed, and prior to the arrival of any new consignment of animals;










(e)


before accepting animals, operators of control posts must:






(i)


have started the cleansing and disinfection operations within a period of 24 hours following the departure of all animals previously held there;










(ii)


ensure that no animals enter the control posts until the cleansing and disinfection operations are completed to the satisfaction of the official veterinarian.




















2.


The requirements in relation to facilities and equipment of control posts, as referred to in Article 12, shall be the following:






(a)


they must be cleansed and disinfected before and after each use, as required by the official veterinarian;










(b)


equipment that comes into contact with the animals present on the control posts must be exclusively dedicated to the premises concerned unless it has been subject to a cleaning and disinfection procedure after coming in contact with the animals or their faeces or urine; in particular, the operator of the control post must provide clean equipment and protective clothes, which must be kept exclusively for the use of any persons entering the control post, and suitable equipment must be made available for cleansing and disinfecting those items;










(c)


litter must be removed when a consignment of animals is moved from an enclosure and, after the cleansing and disinfecting operations, must be replaced by fresh bedding;










(d)


fodder, litter, faeces and urine must not be collected from the premises unless they have been subject to an appropriate treatment in order to avoid the spread of animal diseases;










(e)


they must have suitable facilities for holding, inspecting, examining the animals, whenever necessary;










(f)


an appropriate storage area must be available for bedding material, feed, fodder, litter and manure;










(g)


an appropriate system must be in place to ensure the collection of waste water.








PART 7

Requirements for granting approval of environmentally isolated production establishments of bumble bees referred to in Article 13









1.


The requirements in relation to biosecurity and surveillance measures of environmentally isolated production establishments for bumble bees, as referred to in Article 13, shall be the following:






(a)


the operator must ensure, verify and record by internal controls that the entry into the establishment of small hive beetles is prevented and their presence within the establishment is detectable.
















2.


The requirements in relation to facilities and equipment of environmentally isolated production establishments for bumble bees, as referred to in Article 13, shall be the following:






(a)


the production of bumble bees must be isolated from all the associated activities of the establishment and must be conducted in flying insect-proof facilities;










(b)


the bumble bees must be kept isolated within that building throughout the whole production;










(c)


the storage and handling of pollen within facilities must be isolated from the bumble bees throughout the whole production of bumble bees until it is fed to them.








PART 8

Requirements for granting approval of quarantine establishments for kept terrestrial animals other than primates referred to in Article 14









1.


The requirements in relation to quarantine, isolation and other biosecurity measures of quarantine establishments for kept terrestrial animals other than primates, as referred to in Article 14, shall be the following:






(a)


each unit of the quarantine establishment must:






(i)


be located at a secure distance from surrounding establishments or other places where animals are kept to avoid transmission of contagious animal diseases between resident and quarantined animals;










(ii)


start the required quarantine period when the last animal of the batch is introduced into the quarantine establishment;










(iii)


be emptied of animals, cleaned and disinfected at the end of the quarantine period for the last batch and then be kept free of animals for a period of at least seven days before a batch of animals that has entered into the Union from third countries and territories is introduced into the quarantine establishment;














(b)


litter must be removed when a consignment of animals is moved from an enclosure, and it must be replaced by fresh bedding, after the cleansing and disinfecting operations have been completed;










(c)


fodder, litter, faeces and urine must not be collected from the premises unless they have been subject to an appropriate treatment in order to avoid the spread of animal diseases;










(d)


precautions must be taken to prevent cross-contamination between incoming and outgoing consignments of animals;










(e)


animals released from the quarantine establishment must comply with Union requirements for movements of kept terrestrial animals between Member States.
















2.


The requirements in relation to surveillance and control measures of quarantine establishments for kept terrestrial animals other than primates, as referred to in Article 14, shall be the following:






(a)


the disease surveillance plan must include appropriate zoonoses control of the animals, and must be implemented and updated according to the number and species of the animals present in the establishment and to the epidemiological situation in and around the establishment as regards listed and emerging diseases;










(b)


animals suspected of being infected or contaminated by listed or emerging disease agents must be subject to clinical, laboratory or post-mortem testing;










(c)


the vaccination and treatment of susceptible animals against transmissible animal diseases must carried out as appropriate;










(d)


where ordered by the competent authority, sentinel animals must be used for the early detection of possible disease.
















3.


The requirements in relation to facilities and equipment of quarantine establishments for kept terrestrial animals other than primates, as referred to in Article 14, shall be the following:






(a)


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










(b)


there must be sufficiently large premises at the disposal of the staff responsible for carrying out veterinary checks, including changing rooms, showers and toilets;










(c)


adequate means for catching, confining, where necessary restraining and isolating animals must be available;










(d)


equipment and facilities for cleaning and disinfecting must be available;










(e)


the part of the establishment where the animals are kept must be:






(i)


where ordered by the competent authority to address specific animal health risks, insect-proof with HEPA filter air inlet and outlet, internal vector control, double door access and operating procedures;










(ii)


in the case of captive birds, bird, fly and vermin proof;










(iii)


sealable so as to permit fumigation;










(iv)


of a suitable standard and so constructed that contact with animals outside is prevented and that inspections and any necessary treatment can be easily carried out;










(v)


constructed in such way that floors, walls and all other material or equipment can be readily cleaned and disinfected.












PART 9

Requirements for granting approval of confined establishments of kept terrestrial animals referred to in Article 16









1.


The requirements in relation to quarantine, isolation and biosecurity measures of confined establishments of kept terrestrial animals, as referred to in Article 16, shall be the following:






(a)


they must only admit kept terrestrial animals which have been subject to a quarantine period appropriate to diseases relevant to the species, where those animals coming from establishment other than a confined establishment;










(b)


they must only admit primates complying with the rules as strict as those referred to in Article 6.12.4 of the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE), Edition 2018;










(c)


where necessary, adequate facilities to quarantine kept terrestrial animals introduced from other establishments must be available.
















2.


The requirements in relation to surveillance and control measures of confined establishments of kept terrestrial animals, as referred to in Article 16, shall be the following:






(a)


the disease surveillance plan must include appropriate zoonoses control of the kept terrestrial animals, and must be implemented and updated according to the number and species of the kept terrestrial animals present in the establishment and to the epidemiological situation in and around the establishment as regards listed and emerging diseases;










(b)


kept terrestrial animals suspected of being infected or contaminated by listed or emerging disease agents must be subject to clinical, laboratory or post-mortem testing;










(c)


the vaccination and treatment of susceptible kept terrestrial animals against transmissible diseases must be carried out as appropriate.
















3.


The requirements in relation to facilities and equipment of confined establishments of kept terrestrial animals, as referred to in Article 16, shall be the following:






(a)


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










(b)


adequate means for catching, confining, where necessary restraining and isolating animals are available;










(c)


animal accommodation areas shall be of a suitable standard and constructed in such way that






(i)


contact with animals on the outside is prevented and that inspection and any necessary treatment can be easily carried out;










(ii)


floors, walls and all other material or equipment can be readily cleaned and disinfected.

















ANNEX II

MICROBIOLOGICAL CONTROL PROGRAMME IN HATCHERIES AND DISEASE SURVEILLANCE PROGRAMMES IN ESTABLISHMENTS KEEPING POULTRY AND IN HATCHERIES

PART 1

Microbiological control programme in hatcheries as referred to in Article 7

Microbiological control programme for purpose of hygienic controls shall include the following:






(a)


environmental samples must be collected and undergo a bacteriological examination;










(b)


samples must be taken at least every six weeks and each sampling must include 60 samples.




PART 2

Diseases surveillance programmes in hatcheries as referred to in Article 7 and in establishments keeping poultry as referred to in Article 8









1.


Objective of the diseases surveillance programmes
Demonstration that flocks kept on approved establishments keeping poultry are free from the disease agents listed in points 2 and 3.
The disease surveillance programmes shall, as a minimum, comprise of the disease agents and the listed kept species referred to in point 2.












2.


Disease surveillance for Salmonella serotypes of animal health relevance






2.1.


Identification of infection with the agents:






(a)



Salmonella Pullorum: covering Salmonella
enterica subspecies enterica serovar Gallinarum biochemical variant (biovar) Pullorum;










(b)



Salmonella Gallinarum: covering Salmonella enterica subspecies enterica serovar Gallinarum biochemical variant (biovar) Gallinarum;










(c)



Salmonella arizonae: covering Salmonella enterica subspecies arizonae serogroup K (O18) arizonae.














2.2.


Target poultry species:






(a)


for Salmonella Pullorum and Salmonella Gallinarum: Gallus gallus, Meleagris gallopavo, Numida meleagris, Coturnix coturnix, Phasianus colchicus, Perdix perdix, Anas spp.;










(b)


for Salmonella arizonae: Meleagris gallopavo.














2.3.


Examinations:




Each flock must be clinically examined during each laying or productive period at the best time for detecting the disease in question.






2.4.


Sampling matrix:






(a)


samples must be taken from each flock in the establishment keeping poultry, as appropriate:






(i)


for serological testing: blood;










(ii)


for bacteriological testing:






—


post mortem tissues, especially liver, spleen, ovary, oviduct and ileo-caecal junction,










—


environmental samples,










—


swabs from the cloaca of live birds, in particular from those that appear sick or that have been identified as highly sero-positive;


















(b)


samples to be taken in the hatchery for bacteriological testing:






(i)


chicks that fail to hatch (namely embryos dead-in-shell);










(ii)


second grade chicks;










(iii)


meconium of chicks;










(iv)


down or dust from hatchers and from the walls of the hatchery.


















2.5.


Sampling frame and frequency of sampling:






(a)


in the establishment keeping poultry:






(i)


sampling for Salmonella Pullorum and Salmonella Gallinarum:








Species


Time of sampling


Number of birds to be sampled/Number of environmental samples




Breeding poultry


Productive poultry





Gallus gallus, Meleagris gallopavo, Numida meleagris, Coturnix coturnix, Phasianus colchicus, Perdix perdix and Anas spp



At the point of lay


During production at least once a year


60














(ii)


sampling for Salmonella arizonae:









Species


Time of sampling


Number of birds to be sampled/Number of environmental samples




Breeding poultry


Productive poultry





Meleagris gallopavo



At the point of lay


During production at least once a year


60














(iii)


the number of birds to be sampled in accordance with points (i) and (ii) may be adapted by the competent authority to the known prevalence of infection in the specific Member State concerned and its past incidence in the establishment. In any case a statistically valid number of samples for serological/bacteriological testing to detect infection shall always be taken;














(b)


in the hatchery, samples shall be collected and examined at least once every 6 weeks. The testing shall include at least:






(i)


one pooled sample of down and meconium from chicks from each hatcher;




and






(ii)


sample of:






—


either 10 second grade chickens and 10 dead-in-shell chickens from every flock of origin present in a hatcher on the day of sample collection,




or






—


20 second grade chickens from every flock of origin present in a hatcher on the day of sample collection.






















2.6.


Processing of samples and testing methods:






(a)


samples collected must be subject to:






(i)


serological testing (1);










(ii)


bacteriological testing either as an alternative or in addition to serological testing referred to in point (i); however, samples for bacteriological testing must not be taken from poultry or eggs that have been treated with antimicrobial medicinal products during the two to three weeks prior to testing;














(b)


samples collected must be processed as follows:






(i)


direct enrichment in Selenite-cysteine broth for faecal/meconium and intestinal samples or other appropriate media suitable for samples where competing flora is expected;










(ii)


non-selective pre-enrichment followed by selective enrichment in soya based Rappaport-Vassiliadis (RVS) broth or Müller-Kauffmann Tetrathionate-Novobiocin broth (MKTTn) for samples (such as embryos dead-in-shell) where competing flora is expected to be minimal;










(iii)


direct plating of aseptically collected tissues on to a minimally selective agar, such as MacConkey agar;










(iv)



Salmonella Pullorum and Salmonella Gallinarum do not readily grow in the modified semi-solid Rappaport Vassiliadis (MSRV) medium that is used for monitoring of zoonotic Salmonella spp. in the Union, but it is suitable for Salmonella
arizonae;










(v)


detection techniques must be capable of differentiating serological responses to Salmonella Pullorum and Salmonella Gallinarum infection from serological responses due to the use of Salmonella Enteritidis vaccine, where this vaccine is used (2). Such vaccination must therefore not be used if serological monitoring is to be used. If vaccination has been used, bacteriological testing must be used, but the confirmation method used must be capable of differentiating live vaccinal strains from field strains.


















2.7.


Results:
A flock is considered positive when, following the positive results of the testing performed in accordance with points 2.3 to 2.6, a second test of an appropriate type confirms the infection by the disease agents.
















3.


Diseases surveillance for Mycoplasma spp. of relevance for poultry:






3.1.


Identification of infection with the following agents:






(a)



Mycoplasma
gallisepticum;










(b)



Mycoplasma meleagridis.















3.2.


Target species:






(a)



Mycoplasma gallisepticum: Gallus gallus, Meleagris gallopavo;











(b)



Mycoplasma meleagridis: Meleagris gallopavo.















3.3.


Examinations:
Each flock must be clinically examined during each laying or productive period at the best time for detecting the disease in question.










3.4.


Sampling matrix:
Samples to be taken from each flock in the establishment keeping poultry, as appropriate:






(a)


blood;










(b)


sperm;










(c)


swabs taken from the trachea, the choanae or the cloaca;










(d)


post mortem tissues, especially air sacs from day-old chicks with lesions;










(e)


in particular for the detection of Mycoplasma meleagridis, oviduct and penis of turkeys.














3.5.


Sampling frame and frequency of sampling:






(a)


sampling for Mycoplasma gallisepticum:









Species


Time of sampling


Number of birds to be sampled




Breeding poultry


Productive poultry





Gallus gallus









•


at 16 weeks of age










•


at the point of lay










•


and then every 90 days






During production every 90 days








•


60










•


60










•


60









Meleagris gallopavo









•


at 20 weeks of age










•


at the point of lay










•


and then every 90 days






During production every 90 days








•


60










•


60










•


60


















(b)


sampling for Mycoplasma meleagridis:









Species


Time of sampling


Number of birds to be sampled




Breeding poultry


Productive poultry





Meleagris gallopavo









•


at 20 weeks of age










•


at the point of lay










•


and then every 90 days






During production every 90 days








•


60










•


60










•


60


















(c)


the number of birds to be sampled according to points (a) and (b) may be adapted by the competent authority to the known prevalence of infection in the specific Member State concerned and its past incidence in the establishment. In any case a statistically valid numbers of samples for serological/bacteriological testing shall always be taken.














3.6.


Examinations, sampling and testing methods:
Testing for the presence of infection by serological, bacteriological and molecular tests must be carried out by validated methods recognised by the competent authority.










3.7.


Results:
A flock is considered positive when, following the positive results of the testing performed in accordance with points 3.3 to 3.6, a second test of an appropriate type confirms the infection by the disease agents.








PART 3

Additional information on diagnostic techniques

Laboratories that have been designated by the competent authority to carry out the testing as required in Parts 1 and 2 of this Annex may consult the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (OIE), Edition 2018 for further detailed description of the diagnostic techniques.


(1)  Occasionally in avian species other than Galliformes serological testing results in an unacceptable proportion of false-positive reactions.

(2)  There is currently no test that can differentiate between the response to Salmonella Pullorum and Salmonella Gallinarum infection and vaccination for this serotype.





ANNEX III

MEANS OF IDENTIFICATIONS OF KEPT TERRESTRIAL ANIMALS

The means of identification of kept terrestrial animals are as follows:






(a)


conventional ear tag;










(b)


conventional pastern band;










(c)


electronic ear tag;










(d)


ruminal bolus;










(e)


injectable transponder;










(f)


electronic pastern band;










(g)


tattoo;










(h)


leg-ring.