EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/7068/2019 CIS 
(POOL/G2/2019/7068/7068 -EN 
CIS.docx)  
[…](2019) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
supplementing Regulation (EU) 2016/429 of the European Parliament and of Council as 
regards rules for the entry into the Union, and the movement and handling after entry 
of consignments of certain animals, germinal products and products of animal origin  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the C ommission.    
EN 1  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
supplementing Regulation (EU) 2016/429 of the European Parliament and of Council as 
regards rules for the entry into the Union, and the movement and handling after entry 
of consignments of certain animals, germinal products and products of animal origin  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 
9 March 2016 on transmissible animal diseases  and amending and repealing certain acts in the 
area of animal health (“Animal Health Law”)1, and in particular Article s 234(2), 237 (4) and 
239(2) thereof,  
Whereas:  
(1) Union legislation in the area of animal health was recently updated by the adoption of 
Regulation (EU) 2016/429 . That Regulation, which came into force on 20 April 2016 , 
and applies from 21 April 2021 , repealed and replaced around 50 basic acts . It also 
requires  the adoption of many Commission Delegated and Implementing Regulations , 
in order  to repeal and replace around 400 Commission acts that existed in the area of 
animal health law before the new legal framework established by Regulation (EU) 
2016/429.  
(2) Trading conditions have evolved s ince the adoption of the first animal health rules  at 
Union level,  with the volume of trade in animals, germinal products and products of 
animal origin increasing significantly , both within the Union and with third countries.  
During the same period , as a result of Union  animal health policies  and rules , certai n 
diseases have been eradicated in the Union  and other diseases have been prevented or 
controlled in many Member States. However, on several occasions, emerging diseases 
have posed new challenge s for the Union animal health status , trade  and the local 
econ omy in the areas affected by those diseases .  
(3) The rule s laid down in this act , supplement  those already laid down in Regulation 
(EU) No 2016/429 , and should provide the necessary guarantees to ensure that 
consignments of animals, germinal products and products of animal origin entering the 
Union do not present an animal health risk for kept and wild animals in the Union  that 
could jeopardise the Union health status as regards animal diseases , and could have a 
detrimental economic  impact on the  sectors involved .  
(4) Article 234 of Regulation (EU) 2016/429 provides that pending the adoption of 
delegated acts laying down animal health requirements as regards a particular species 
and category of animal, germinal product or product of animal origin, Member States 
may, following an evaluation of the risks involved, apply national rules, provided that 
those rules comply with certain requirements laid down in that Regulation.  
                                                 
1 OJ L 84, 31.03.2016, p. 1.   
EN 2  EN (5) The existing animal health r ules, laid down in previous Comm ission acts concerning 
the control of animals , germinal products  and products of animal origin entering the 
Union have proved to be effective , therefore the aim and substance of those existing 
rules should be  maintained in this Regulation, but updated to t ake account of the rules 
on better regulation, the new animal health framework laid down in Regulation (EU) 
No 2016/429, as well as newly available scientific knowledge, international standards 
and the experience  in the application of previous Union acts .  
(6) The animal health requirements for the entry into the Union of consignments falling 
within the scope of this Regulation should ensure a smooth transition from the 
requirements laid down in pre-existing Union acts, in order to avoid unnecessary  trade  
disru ptions . 
(7) Regulation (EU) 2016/429 lays down rules for the prevention and control of animal 
diseases which are transmissible to animals  or to humans . In particular, Chapter 1  of 
Part V thereof , which lays down the animal health requirements for the entry int o the 
Union of consignments of animals, germinal products and products of animal origin , 
provides for the Commission to adopt delegated acts to supplement the animal health 
requirements  already laid down in that Regulation .  
(8) Article 229(1) of Regulation (E U) 2016/429 lays down the requirements under which 
Member States are to permit the entry into the Union of consignments of animals, 
germinal products and products of animal origin , as regards conditions  concerning the 
third country or territory of origin, the establishment of origin, the animal health 
requirements that those consignments  are required to comply with, and the animal 
health certificate , declaration s or other document that should accompany such 
consignments . 
(9) In addition, Article 234(1) of Regulation (EU) 2016/429 stipulates that the animal 
health requirements for the entry into the Union of consignments of species and 
categories  of animals, germinal products and products of animal origin from third 
countries  or territories  or zones thereof  must be at least as stringent as th ose laid down 
in that Regulation , and in delegated acts adopted  within the framework of that 
Regulation,  applicable to the movements within the Union of th ose species and 
categories of those commodities , or must offer equivalent guarantees to the animal 
health requirements provided for in Part IV of that Regulation.  
(10) Article 234(2) of Regulation (EU) No 2016/429 provides for delegated acts to be 
adopted in order to supplement the rules laid down in that Re gulation, as regards the 
animal health requirements for the entry into the Union of species and categories of 
animals, germinal products and products of animal origin from third countries and 
territories, and for the movement within the Union and handling of those commodities 
after their entry into the Union, in order to mitigate the possible risks involved.  
(11) Article 237(1) of Regulation (EU) No 2016/429 provides  that Member State are only 
to permit the entry into the Union of consignments of animals, germi nal products and 
products of animal origin if such consignments are accompanied by the animal health 
certificate s and the declarations or other documents  required under that Regulation . 
Furthermore, Article 237(2) thereof stipulates that the animal health  certificate must 
have been verified and signed by an official veterinarian in the third country or 
territory of origin.  In this context,  Article 237(4) of Regulation (EU) No 2016/429 
provides for the Commission to adopt delegated acts concerning derogations from the 
animal health certificate requirements laid down in Article 237(1) and Article 237(2)  
EN 3  EN of that Regulation, and to lay down rules requiring those consignments of those to be 
accompanied by declarations or other documents.  
(12) Article 239(2) of Regulation (EU) No 2016/429 provides for the Commission to adopt 
delegated acts concerning special rules and additional requirements for certain specific 
types of entr y into the Union of consignments animals, germinal products and 
products of animal origin, and for derogations from the general animal health 
requirements laid down in Articles 229(1) and 237(1) of that Regulation, and the 
supplementing rules laid down in delegated acts adopted  pursuant to Articles 234(2) 
and 237(4) thereof . 
(13) The supplementing rules to be laid down this Regulation pursuant to Articles 234(2) 
and 239(2) of Regulation (EU) 2016/429 are interrelated , Article 234(2) lays down the 
general requirements for the entry int o the Union  of consignments of animals, 
germinal products and products of animal origin , while Article 239(2) thereof lays 
down the special rules and additional requirements for derogations from those  general 
requirements.  
(14) The animal health certificat e requirements provided for in Article 237 of Regulation 
(EU) 2016/429 a re part of the framework of rules relating to the entry into the Union 
of consignments of animals, germinal products and products of animal origin . The 
empowerment granted to the Commiss ion under Article 237(4) of that Regulation  to 
grant derogations from the animal health requirements is part of that general 
framework of rules.   
(15) Regulation (EU) 2016/429 already provides a number of definitions. In addition, this 
Regulation should also ha ve regard to the definitions laid down in other Union acts in 
the related areas of food hygiene and official controls, such as the definitions laid 
down in Regulation (EC) 853/20042. However, f or the purpose of laying down the 
animal health requirements fo r the entry into the Union of  animals, germinal products 
and products of animal origin it is appropriate to include  particular definitions , 
including definitions  for certain  categories of animals, germinal products and products  
of animal origin . These definitions are needed to clarify which categories of animals, 
germinal products and products of animal origin represent an animal health risk and 
are therefore subject to the animal health requirements for entry into the Union.   
(16) In the interests of consis tency of Union legislation, and based on the animal health risk 
they represent,  the definition for ‘fresh meat ’ for the purpose of this Regulation should 
incorporate the definitions for ‘fresh meat ’, ‘minced meat ’ and ‘meat preparations ’ 
laid down in Annex  I to Regulation (EC) 853/2004.  
(17) In addition , the definition for ‘meat products ’ for the purpose of this Regulation should 
incorporate the definitions for ‘meat products ’, ‘processed stomachs ’, ‘bladders ’, 
‘intestines ’, ‘rendered fats ’, ‘meat extracts ’ and ‘blood products ’ laid down in 
Regulation (EC) 853/2004, as, from an animal health point of view, all of those 
commodities represent the same animal health risk and they should be subjected to the 
same risk mitigating measures.  
(18) The definition of ‘carcass ’ laid down in Regulation (EC) 853/2004 should be adapted 
to define ‘carcass of ungulate’ in order to differentiate it  from  'offal' as those two 
commodities represent different animal health risks , with 'offal' representing a higher 
risk. 
                                                 
2 Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying 
down specific hygiene rules for food of animal origin  (OJ L 139, 30.4.2004, p. 55 ).  
EN 4  EN (19) ‘Casings ’ should be defined  in this Regulation and th at definition should be in line  
with the definition included in the glossary of the Terrestrial Animal Health Code  of 
the World Organisation for Animal Health (OIE). This definition should clarif y which 
products of animal origin must  be considered as casings and therefore should undergo  
the specific risk mitigating treatments  provided for in this Regulation . 
(20) Article 229(1) of Regulation (EU) 2016/429  provides  that the entry into the Union of 
consignments of animals, germina l products and products of animal origin is only to 
be permitted if they come from third countries or territories listed  for the entry in to the 
Union  of the particular species and category of animals , germinal products or products 
of animal origin,  in acco rdance with the criteria laid down in Article 230(1), and they 
comply with the specific animal health requirements as regards listed diseases. This 
Regulation should lay down the responsibility for the competent authority to verify 
that such consignments entering the Union comply with  those general requirements . 
(21) Article 237(1) of Regulation (EU) No 2016/429 provides that the entry into the Union 
of consignments of species and categories of animals, germinal products and products 
of animal origin from third countries or territories is only to be permitted where those 
consignments are accompanied either by an animal health certificate , issued by the 
competent authority of the third country or territory, or  by declarations or other 
documents, or by all of those  documents.  This Regulation should, therefore, clarify 
which documents are required in each case and should lay down the responsibility  for 
the competent authority to verify that  such consignments  entering the Union comply 
with that general requirement.  
(22) The information to be contained in the animal health certificates, declarations and 
other documents accompanying consignments of animals, germinal products and 
products of animal origin must accurately reflect whether or not those consignments  
comply with the general requirements provided for in Regulation (EU) 2016/429 and 
the relevant requirements laid down in this Regulation. This Regulation should, 
therefore, lay down the obligations for operators responsible for the entry into the 
Union of such consign ments and for the competent authorities of the Member State  of 
entry into the Union , as regards the validity of the documents accompanying the 
consignments and the eligibility of such consignments to enter the Union.  
(23) Taking into account animal health risks such as incubation periods for diseases , and in 
order to avoid the misuse of animal health certificates , it is necessary to establish a 
time limit for the period of validity of those certificates  only in the case of animals and 
germinal  products , as they pose a higher animal health risk than products of animal 
origin which may have undergone risk mitigating measures . However, as the transport 
by sea of live animals and of germinal products may take longer than 10 days , the 
validity  perio d of the certificate in this case should be extended provided that certain 
risk mitigating measures have been taken . 
(24) The animal health requirements that need to be complied with, and the guarantees to 
be provided by third countries and territories , for the entry into the Union of 
consignments of animals, germinal products and products of animal origin are related 
to the diseases listed  in Article 5 and in Annex I I to Regulation (EU) 2016/429  and 
their categorisation  into categories A, B, C, D and E , as p rovided for in Article 9(1) of  
EN 5  EN that Regulation and in the Annex to Commission Implementing Regulation (EU) 
2018/18823.  
(25) Chapter 1 of Part II  of Regulation (EU) 2016/429 provides for the rules on disease 
notification and reporting  to ensure an early detecti on and an effective disease control 
in the Union. This Regulation should provide for the details on the notification and 
reporting systems to be in place in the third countries or territories to guarantee  
equivalent systems to those implemented in the Unio n, including the diseases that 
should be notifiable and reportable. In this sense, live animals can transmit the 
diseases for which they are a listed species  in Regulation (EU) 2018/1882, h owever, 
not all the products of animal origin and germinal products  obtained from those 
animals can transmit all those diseases. T his Regulation should clarify which are the 
animal diseases of concern and therefore notifiable and reportable for each particular 
species and category of animals, germinal products and product s of animal origin  
intended for the entry into the Union.  
(26) The animal health requirements laid down  in this Regulation should be  based on 
different levels of protection from the animal health risks, starting with the 
requirements  for the third country  or territory of origin  or zone thereof , or also the 
compartment thereof  in the case of aquaculture animals, the  establishment of origin of 
the animals, and the animals and the establishment of origin of the products of animal 
origin or the centres for collection of germinal products.  
(27) Disease surveillance and traceability in the establishments are key elements of the 
disease control policy in the Union. T his Regulation should include certain basic 
requirements regarding traceability and animal health vis its in the establishments of 
origin of the animals, germinal products and products of animal origin equivalent  to 
those  laid down in Regulation (EU) 2016/429, and in delegated and implementing acts 
adopted within the framework of that Regulation .  
(28) Furtherm ore, where a certain type of establishments keeping animals or germinal 
products in a third country or territory pose a particular animal health risk, it should be 
subject to specific approval by the competent authority in the third country or territory, 
providing equivalent guarantees as those provided in Articles 92 to 100 of Regulation 
(EU) 2016/429 for certain establishments in the Union.  
(29) Consignments of a nimals, germinal products and products of animal origin intended 
for the entry into the Union shou ld not be considered as representing an animal health 
risk in their country or territory of origin  and they should not be  subject to national 
eradication programmes or any other national restrictions based on animal health 
concerns .  
(30) The animal health requ irements for the entry into the Union of consignments of 
animals , germinal products and products of animal origin  must provide effective 
protection against the introduction  and spread of transmissible animal diseases in the 
Union . The entry into the Union of those consignments should not be permitted  from 
third countries  or territories  or zones  or in the case of aquaculture animals, 
compartments  thereof , infected with certain listed diseas es for which the Union has 
disease -free status, and which consequentl y present a serious risk for the animal health 
of animals within the Union.  
                                                 
3 Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of 
certain disease preventio n and control rules to categories of listed diseases and establishing a list of 
species and groups of species posing a considerable risk for the spread of those listed diseases.   
EN 6  EN (31) The disease freedom  of the third country or territory or zone and in the case of 
aquaculture animals, the compartment of origin must be assessed by the Union based 
on information related to disease surveillance provided by the competent authorit y of 
the third country or territory , and taking into account  Union animal health rules  as 
those provided for in Part II of R egulation (EU) 2016/429 and Commission Delegated 
Regulation (EU) 2019/…[ C(2019)4057]4. Specific conditions  for certain diseases and 
circumstances may be  required as additional risk mitigating measures .  
(32) The disease freedom of  a third country or territory or zone thereof must be based on 
internationally recogni sed diagnostic tests and methods performed under the same 
standards and procedures as those applied within the Union .  
(33) To ensure that the health status of animals , germinal products and products of animal 
origin  intended for entry into the Union complies with the guarantees provided by the 
third country  or territory of origin  or zone thereof , this Regulation should provide for a 
minimum residency period for the animals in the third country  or territory of origin  or 
zone thereof,  as well as in the establishment of origin, and a minimum period without 
contact with commodities of a lower health status, before being dispatched to the 
Union. The length of the minimum period of residency should take into account the 
incubati on period of relevant diseases, and the intended destination and use of the 
animals , germinal products and products of animal origin .  
(34) In the case of dogs, cats and ferrets , the residency period is un necessary as vaccination 
against rabies,  the disease of greatest concern for those species, is re quired  in all cases. 
Moreover,  horses intended for competitions , races  and cultural events, because of their 
high level health status , should be exempted from a minimum residency period when 
those horses comply with  additional guarantees.  
(35) The health status of the animals , germinal products and products of animal origin  
intended for entry into the Union may be  jeopardised during their transport from the 
place of origin to the place of entry into the Union  if they ent er into contact with 
animals or products not complying with the same requirements or if they transit 
through third countries or territories with a lower health status than the country or 
territory of origin , therefore certain preventive measures should be applied in order to 
preserve  their health status .  
(36) Terrestrial a nimals , hatching eggs and aquatic animals intended for entry into the 
Union should only be transported through or unloaded in third countries or territories 
which are also listed  for the entry  into the Union of the same species and categories of 
animals and hatching eggs which therefore provide equivalent animal health 
guarantees as the third country or territory of origin.   
(37) However, the transport of terrestrial animals and hatching eggs by mea ns of aircraft or 
vessel  could be subject to unforeseen events such as mechanical problems of the 
means of transport, strikes in airports and seaports or unforeseen delays. It is therefore 
appropriate  to provide for derogations in those cases where guarant ees can be given, in 
order to allow the continuation of the transport of the terrestrial animals  and hatching 
eggs to the Union , while at the same time ensuring the health status of t hose 
commodities and preventing additional  animal health risks . 
(38) Assembly operations of animals in third countr ies or territor ies of origin may pose an 
additional risk to the animal health status of the animals intended for entry into the 
Union , as a result of coming mixing and getting into contact with animals of different 
                                                 
4 Commission Delegated Regulation (EU) 2019/…[C(2019)4057][Part II of Regulati on (EU) 2016/429].   
EN 7  EN origins. Therefore, the number, the duration of  those operations and the species 
allowed  to undergo  such operations should be limited to the minimum and for those 
species with reliable traceability systems.  
(39) In addition  to general animal health requirements , it is necessary to provide specific 
requirements taking into account the animal health risks linked to the different species 
and categories of terrestrial animals falling within the scope of this Regulation.  
(40) Different species of ungulates, as defined in Re gulation (EU) 2016/429, are listed as 
susceptible species for different listed diseases  in Commission Implementing 
Regulation (EU) 2018/1882 . Furthermore, listed diseases are set out in different 
categories for different species of ungulates  in the same Re gulation . Therefore, this 
Regulation should clearly establish the specific requirements and guarantees in 
relation to listed diseases for the different species and categories of ungulates.  
(41) In order to prevent the occurrence of diseases  from which the Union  is considered free , 
the general requirement for the third country or territory of origin or zone thereof of 
ungulates should be an e quivalent disease freedom . For those diseases for which the 
Union has a compulsory eradication programme, this Regulation s hould provide for 
risk mitigating measures where the third country or territory of origin is not 
completely free  of such diseases . 
(42) Where consignments of ungulates are intended for the entry into Member States which 
are officially disease -free, or which have an approved programme for infectious 
bovine rhinotracheitis/infectious pustular vulvovaginitis, bovine viral diarrhoea or 
infection with Aujeszky’s disease virus, those consignments should comply with 
additional requirements to ensure that those  animals do not jeopardise the health status  
of those specific Member States  as regards those diseases . 
(43) Special rules as regards the third country , territory or zone  of origin and additional 
animal health requirements should  apply  where ungulates originate  from a c onfined 
establishment  and are intended for entry into a confined establishment in the Union , 
taking into account the specificity of th ose confined establishments  and the specific 
conditions they comply with in order to be approved  by the competent  authority of the 
third country, territory or zone of origin . 
(44) The confined establishment of origin could be located  in a third country or territory 
which is not listed for the entry into the Union of the specific species of ungulates. 
However, the national  legislation and the veterinary services of the third country or 
territory should  have been assessed and listed for the entry into the Union of other 
commodities falling within the scope of this Regulation. In addition , the establishment 
of origin should c omply with additional requirements as regards disease surveillance, 
veterinary supervision, record keeping and operations . In order to ensure that those 
guarantees can be provided , specific conditions for the approval of those confined 
establishments by th e competent authority in the third country or territory should  be 
laid down in this Regulation . A list of such confined establishments should be 
established by the Member State of destination, following a  favourable  assessment by 
the competent authority of  that Member State of all relevant information provided by 
the establishment  as regards the animal health risks involved . 
(45) Specific animal health requirements should apply for the entry into the Union of 
poultry and other captive birds  to address the partic ular risks posed by the relevant 
listed diseases  for those animals . These requirements should take account of the 
category , species  and intended use of poultry and other captive birds, and provide  
EN 8  EN effective protection against the spread into the Union of disease s of concern  from third 
countries  or territories .  
(46) In order to facilitate the trade of consignments of small amounts of poultry, specific 
requirements and derogations  should  be established for consignments with less than 20 
heads of poultry other th an ratites . 
(47) Taking into account the activities and the animal health risks associated with captive 
birds, consignments of those animals should  only be permitted to enter the Union if 
they come from establishments approved by the competent authorities in th e third 
countries, territories or zones of origin of the captive birds, and the captive birds 
should be quarantined upon their arrival in the Union in order to confirm the absence 
of any disease of concern.  
(48) In addition, w here consignments of birds and hat ching eggs are intended for Member 
States with disease -free status  from infection with Newcastle disease  virus without 
vaccination , additional requirements should be complied with in order to ensure that 
those consignments  do not jeopardise the health status for that disease of those specific 
Member States.  
(49) The small hive beetle ( Aethina tumida ) is one of the disease s of most concern for the 
bees. It  is largely  exotic to the Union but has spread global ly in the last decades, 
thereby creating serious problems for the apiculture industry  potentially affecting also 
bumbe bees . The Tropilaelaps  mites ( Tropilaelaps  spp.) are potentially devastating 
pathogens of honeybees, exotic to the Union. Effective and safe treatments against 
these diseases are at pres ent not available. If these diseases entered the Union  by 
entering consignments, they would pose a risk to the sustainability of the apiculture 
sector and beyond, potentially affecting the agriculture and the environment which 
benefits from pollination ser vices by kept and wild bees.  
(50) In addition, American foulbrood occasionally occurs in the Union  but is controlled for 
trade of honeybees, while certain areas in the Union have been recognised as free of 
Varroa  mites and protected by additional trade guarant ees to keep places of 
destination  in the Union  safe. Rules at Union level have been, and remain, essential to 
mitigate the risk of entry into the Union of the above pathogens as associated with 
consignments of honeybee s and bumble bee s and therefore such rules should be laid 
down in this Regulation.  
(51) Only queen bees without brood and accompanied by a small number of attendants in 
single queen bee cages can be easily checked for infestation with small hive beetle  or 
with Tropilaelaps  mites , therefore the entry into the Union of honeybees  should be 
limited to such consignments.  
(52) Colonies of bumble bees  bred and reared in environmentally isolated establishments 
are often traded for the horticultural industry. In view of commonly used facilities, 
procedures and closed containers used for the shipped colonies, the entry into the 
Union of bumble bees  (Bombu s spp.) should be permitted only for colonies bred, 
reared and packaged solely under environmentally  controlled conditions in 
establishments and which can be checked to be free of the small hive beetle.  
(53) Because its potential effects on humans and animals, rabies is the listed disease of 
most concern in the Union affecting  dogs, cats and ferrets  and therefore Member 
States are required to  carry out a compulsory eradication programme  against infection 
with that disease  in accordance with  Regulation (EU) 2019/…  as regards rules for 
surveillance, eradication programmes, and disease -free status for certain listed and  
EN 9  EN emerging diseases  [document C(2019)4056] . Taking into account the availability and 
effectiveness of the existing vaccines against this disease,  vaccination should be 
required  for all consignments of dogs, cats and ferrets  entering the Union to prevent 
any possibility of the introduction of rabies into the Union.  
(54) Dogs intended for the entry into a Member State with disease -free status or an 
approv ed eradication programme for Echinococcus multilocularis  should comply with 
additional requirements in order to ensure the protection of that status in those 
Member States. As this regard, a preventive treatment should be applied  to those dogs 
before enter ing the Union. However, special rules as regards rabies and infestation 
with Echinococcus multilocularis  and additional animal health requirements should 
apply  where dogs, cats and ferrets are intended for a confined establishment in the 
Union taking into account the specificity of their activities and the specific conditions  
under which animals are kept in those establishments . 
(55) Germinal products, in particular semen, but also to a lesser extent oocytes and 
embryos may represent an important risk  for the  spread of animal diseases. They are 
collected or produced from a limited number of donors , but are used widely in the 
general animal population so they can, if not handled properly  or not classified with 
the correct health status , be a source of diseases for  a large number of animals. Such 
cases have occurred in the past and have caused substantial  economic lo sses. 
Therefore, the animal health requirements for entry into the Union of germinal 
products of certain kept terrestrial animals shall be established.  
(56) The requirements for the entry into the Union of germinal products  of ungulates  
should primarily consider the requirements for entry into the Union of live animals.  
(57) Specific requirements for the germinal product establishments where germinal 
products of ungulates, eligible for entry into the Union, are collected, produced, 
processed and stored and the traceability and animal health requirements for germinal 
products s hould reflect those established for the movements within the Union.  
(58) Due to the need to move germinal products from confined establishments located in 
third countries to confined establishments located in the Union,  special traceability and 
animal health r equirements for such entry into the Union should be laid down in this 
Regulation.  
(59) Animal health requirements for the entry into the Union of hatching eggs should 
address the risks posed for the introduction into the Union of listed diseases by the 
differen t categories of hatching eggs, therefore they should relate to those for the entry 
into the  Union of the respective species or categories of birds.  
(60) Where hatching eggs of poultry are intended for the entry into  Member States with 
status -free from  infection  with Newcastle disease virus  without vaccination , they 
should comply with additional requirements to ensure that those eggs do not 
jeopardise the status of those specific Member States.  
(61) Products of animal origin  can transmit  disease agents to animals and products . The 
animal health risk linked to fresh and raw  products of animal origin is obviously 
higher that those that have been processed and treated . Therefore the animal health 
requirements for the third country or territory of origin of fresh meat, raw  milk, 
colostrum and colostrum -based products should be stricter than those for meat 
products  and dairy products. However, the treatment applied to those treated products 
should be effective to mitigate the risk they pose depending on the species of origin  of 
the product and the country or territory of origin.   
EN 10  EN (62) The risks linked to fresh meat entering the Union  should be mitigated by way of  
requirements as regards the disease freedom of the third country or territory of origin 
and requirements regarding anim al disease s for the live animals from which the meat 
is obtained , the dispatch of the kept animals to slaughter, the slaughter and killing  
operations, the handling  and preparation  operations.  
(63) Fresh meat  of terrestrial animals can be obtained from kept ani mals, including farmed 
game as defined in Regulation (EC) No 853/2004, and wild animals . However , in the 
Union some  species are traditionally kept as production animals, in controlled 
environments, whereby specific health statuses for those species have be en achieved. 
This applies, i n particular, to terrestrial animals belonging to the species Bos taurus , 
Capra hirchus  and Ovis aries . In order to safeguard their health status and provide 
adequate guarantees for these production species in the Union, it is appropriate to 
exclude those species  from the possibility to be categorised as farmed game  or wild 
animals, when the fresh meat int ended to entry into the Union originate from those 
species.   
(64) When an outbreak of a relevant animal health disease occurs in a third country  or 
territory , the date and location of slaughter  of kept animals  or the date of killing of 
wild animals or farmed ga me are key to establish the possible animal health risks 
associated with those animals  and the products of animal origin  thereof . Therefore,  the 
date of slaughter or killing need s to be established , in order to verify that the animals 
have been slaughtered  or killed in a period of time without outbreaks of disease and 
when the third country or territory was listed to entry fresh meat into the Union  to the 
Union.  
(65) The type of treatment to be applied to products of animal origin s hould  be in line with 
the ris k posed by the third country, territory or zone thereof manufacturing the meat 
product. Non -specific treatments should be assigned only to  third countries or 
territories or zones thereof that provide all the guarantees  as regards freedom of the 
relevant di seases . In the case of third countries or territories or zones thereof that do 
not provide  all th ose guarantees, the entry into the Union of products of animal origin 
should be  permitted when those products are subject to a specific treatment.  
(66) When the thi rd country or territory or zone thereof is sourcing raw meat to produce 
meat products from a third country or territory  or zone thereof listed for entry into the 
Union of meat products of the relevant species subject to a specific treatment, in order 
to mi tigate all possible animal health risks the meat product shall always be subjected 
to the most severe specific treatment.  
(67) Meat products containing poultry meat from a third country or territory or zone thereof 
where there has been an outbreak of highly pa thogenic avian influenza or infection 
with Newcastle disease virus shall be subjected to a treatment effective to mitigate the 
risk in the third country or territory or zone thereof listed  for entry into the Union , to 
allow continuation of trade before measures for control such as regionalisation are 
implemented. The immediate application of a risk mitigating treatment after an 
outbreak decreases the animal health risks and at the same time reduces the impact on 
trade. 
(68) When meat products are manufactured from fresh meat from different species the 
treatment applied should eliminate any  possible animal health risks . Therefore, if the 
treatment is applied before mixing, the different types of fresh meat should receive t he 
relevant treatment assigned to  the species of origin of the fresh meat . However, if the  
EN 11  EN treatment is applied after mixing, the final meat product should undergo the treatment 
assigned to the fresh meat ingredient with the highest animal health risk.  
(69) The treatments to mitigate the specific animal health risks linked to the entry of  
casing s should be  reviewed and updated taking into account the conclusions and 
recommendations of the latest scientific evidence assessed by the EFSA Panel on 
Animal Health an d Welfare5. 
(70) Fresh meat and products of animal origin from equine animals do not pose an animal 
health risk in relation to listed diseases and therefore animal health requirements for 
fresh meat and products of animal origin from equine animals intended for  entry into 
the Union should  not be laid down in this Regulation . 
(71) The conditions for entry into the Union of raw milk, dairy products, colostrum and 
colostrum products are based on the animal health risks that the species of origin may 
pose, which are main ly related to foot and mouth disease  and can be mitigat ed with the 
application of specific  treatment. Therefore, dairy products of animal species other 
than Bos taurus, Ovis aries, Capra hircus, Bubalus bubalis and Camelus dromedaries  
should undergo the mo st severe risk mitigating treatment.  
(72) Treatments for products of animal origin should be carried out always in the third 
country or territory  of origin or  zone thereof listed  for the entry of  those products into 
the Union. The type of treatment to be applie d to the product s of animal origin should 
be in line with the animal health risk and therefore in line with the risk posed by the 
third country or territory of origin.  
(73) Aquatic animals of listed species are sometimes transported by sea in vessels which 
may exchange water during the voyage. In such cases, in addition to a health 
certificate, the animals should also be accompanied by a declaration which is signed 
by the Mas ter of the vessel and which outlines details of the ports of origin and 
destination as well as any other ports visited during the journey. This declaration 
should confirm that the animals of listed species on board the vessel have not been 
exposed to any c onditions that could have altered their health status during the journey 
to their final destination.  
(74) Aquatic animals may enter the Union for many different purposes. Given the disease 
risk associated with the movement of live animals, such animals which e nter the 
Union for human consumption should be treated in the same way as if they were 
entering the Union for other purposes such as farming or release into the wild. 
Products of animal origin from listed diseases represent a lower risk, and the measures 
to be taken in relation to these products which enter the Union for further processing, 
are therefore, less rigorous than those which apply to live animals.  
(75) Releasing aquatic animals into the wild in natural waters is a high -risk activity if those 
animals are infected with a listed disease. Specifically in the case of category A and B 
diseases, the third country or territory of origin or zone or compartment thereof should 
be free of those diseases. In addition, aquatic animals which have entered the Union 
with the purpose of being released into the wild in natural waters should, in all cases, 
even when the Member State of destination or zone or compartment thereof is not free 
from a specific category C disease, originate from a third country or territory or zone 
or compartment thereof which has been declared free of that category C disease.  
                                                 
5 EFSA Panel on Animal Health and Welfare (AHAW); Scientific Opinion on animal health mitigation 
treatments as regards imports of animal casings. EFSA Journal 2012; 10(7):2820. [32pp.] 
doi:10.2903/j.efsa.2012.2820. Available online: www. efsa .europa.eu/efsajournal   
EN 12  EN (76) Member States may take national measures under Article 226 of Regulation (EU) 
2016/429  which are designed to limit the impact of diseases other than listed diseases  
within  their own territory . In such cases, consignments of species which are 
susceptible to the diseases  to which those national measures apply  shall also originate 
from third countries, territories, zones or compartments thereof, which are free of 
those disease s.  
(77) Article 226 of Regulation (EU) 2016/429 reflects the same intent as Article 43 of 
Directive 2006/88/EC as it allows Member States to take national measures against 
diseases which are not listed. It is appropriate  therefore, to continue to recognise the  
list of Member States that have taken national measures under Directive 2006/88/EC 
and the list of diseases for which they have obtained those measures.  These details are 
set out in Annex 29 of this Regulation .  
(78) The requirement for aquatic animals of listed species and products of animal origin 
from those animals to originate from a disease - free third country or territory or zone 
or compartment thereof is not mandatory in all situations. Certain risk mitigation 
measures can be taken which facilitate the entry into the Union of aquatic animals and 
certain products of animal origin thereof which do not originate from a disease - free 
third country or territory or zone or compartment thereof. Certain risk mitigation 
measures are acceptable for aquatic animals of listed species and different mitigation 
measures are acceptable for products of animal origin from those species.  
(79) The mitigation measures that apply to aquatic animals include their being consigned to 
a disease  control aquatic food establishment, a confined establishment or an approved 
quarantine establishment after entry into the Union. A number of other risk mitigating 
measures apply to molluscs and crustacea of listed species which enter the Union alive 
and i n compliance with Regulation (EU) No.853/2004 but which represent an 
acceptable risk because of the way they have been treated or packaged before dispatch 
or because they are not intended for storage in the Union, prior to processing.  
(80) Certain products of a nimal origin of listed species may also be derogated from the 
requirement to originate in a third country or territory or zone or compartment thereof 
which is free of relevant listed diseases. The risk mitigation measures which allow 
such trade to occur relate to the  fact that the animals are consigned to a disease control 
aquatic food establishment in the Union for further processing , or to the fact that the 
products of animal origin consist of fish which were slaughtered and eviscerated prior 
to dispatch to the Union . In either case, the risk posed by the products of animal origin 
is assessed to be acceptable.  
(81) Commission Implementing Regulation (EU) 2018/1882 establishes a list of species 
and groups of species that pose a considerable risk for the spread o f the diseases which 
are listed in Article 5 and Annex II to Regulation (EU) 2016/429. This list also 
includes a list of vector species. Many of these species do not however, act as vectors 
in all circumstances. Details of the circumstances in which these species are vectors of 
the listed diseases are set out in Annex 30 of this Regulation. In circumstances where 
aquatic animals of listed species do not fulfil the conditions to be vectors, they are not 
covered by the provisions of this Regulation.  
(82) All of th e derogations and handling requirements which are set out in Part V of this 
Regulation in relation to aquatic animals of listed species and products of animal 
origin from those listed species, also apply to the diseases for which Member States 
have taken n ational measures under Article 226 of Regulation (EU) 2016/429 and to 
the relevant susceptible species set out in Annex 29.   
EN 13  EN (83) It is important that aquatic animals of listed species, products of animal origin from 
those species, and water in which they are tr ansported, are handled appropriately after 
entry into the Union. The objective is to ensure that they do not represent a disease 
risk after entry. Appropriate handling includes ensuring that the animals and products 
of animal origin are transported directl y to the place of destination and are not released 
or otherwise immersed in natural waters of the Union, where they could cause a 
potential disease risk.  
(84) In certain cases and for reasons which are justifiable, the competent authority at the 
place of desti nation may however, allow authorisation for such animals to be released 
into natural waters. In all such cases, the competent authority ensures that the release 
or immersion does not jeopardise the health status at the place of release. Further than 
that, even if the receiving waters are not free of a specific Category C disease, the 
animals to be released should be free of that disease, in order to ensure the best overall 
health status is achieved for wild populations in natural waters of the Union.  
(85) Deroga tions  and special rules for transit are established under specific conditions 
linked to the place of origin to cover situations where the Union is not the final 
destination for the animals and products thereof  and to take into account geographical 
constrai ns and geopolitical factors .  
(86) Derogations and special rules are also established to allow for the transit of 
consignments of animals and products thereof  via a third country or territory between 
Member States to cover situations where such type of entry in to the Union is required 
by a Member State.  
(87) Special rules under Article 239 of Regulation (EU) 2016/429 are laid down to allow 
the return of certain commodities that have been refused by the competent authorities 
of a border control post of a third country  or territory taking into account that those 
commodities have been produced under the Union’s animal health legislation.  
(88) Special rules are also necessary for the return to the Union of registered horses after 
temporary export to third countries in order to  participate in races, competitions and 
cultural events.  
(89) This Delegated Regulation should be applicable from 21 April 2021 in accordance 
with the date of application provided for in Regulation (EU) 2016/429,  
HAS ADOPTED THIS REGULATION:  
PART I  
General rules  
TITLE 1 
SUBJECT MATTER , SCOPE AND DEFINITION S 
Article 1  
Subject matter and scope  
1. This Regulation lays down the animal health rules concerning the entry into the 
Union of consignments of certain species and categories of animals, germinal 
products and products of animal  origin from third countries, territories, zones 
thereof , or compartments in the case of aquaculture animals . It also lays down rules 
concerning the movement and handling of those consignments after their entry in the 
Union.   
EN 14  EN 2. Part I  lays down : 
(a) the obligatio ns on the competent authority  of Member States  to permit the 
entry into the Union of consignments of animals, germinal products and 
products of animal origin of species and categories  of animals  falling with the 
scope of this Regulation  (Articles 3 and 4) ; 
(b) the obligations on the operators  regarding the entry into the Union, and the 
move ment  and handl ing after entry, of consignments of animals, germinal 
products and products of animal origin (Article 5) ;  
(c) the general animal heal th requirements for the entry into the Union, and the 
movement and handling after the entry  of the consignments referred to in 
points (a) and (b), and derogations from those general requirements , applicable 
to all the species and categories of animals (Articles 6 to 10) . 
3. Part II lays down the general animal health requirements  for the entry into the Union, 
as well as the movement and handling after the entry , and derogations from such 
requirements for terrestrial animals (Title  1). 
In addition, it lays down specific animal health requirements that are also applicable 
to the follo wing species and categories of terrestrial animals:  
(a) ungulates  (Title 2) ; 
(b) poultry and captive birds , except captive birds imported for conservation 
programmes  approved by the competent authority of the Member State of 
destination  (Title 3) ;  
(c) honeybees ( Apis mellifera ) and bumble bees  (Bombus spp.)  (Title 4) ; 
(d) dogs, cats and ferrets  (Title 5) . 
4. Part III lays down the general animal health requirements for the e ntry into the 
Union , as well as the movement and handling after the entry , and derogations from 
such requirements for germinal products  of the following species and categories of 
kept terrestrial animals:  
(a) bovine, porcine, ovine, caprine  and equine animals  (Title 1) ; 
(b) poultry and captive birds  (Title 2) ; 
(c) animals other than those listed in points (a) and (b).  
5. Part IV lays down the general animal health requirements for the entry into the 
Union, as well as the movement and handling after the entry , and derogations from 
those requirements for products of animal origin  of the following species and 
categories of  terrestrial animals:  
(a) kept and wild ungulates;  
(b) poultry;  
(c) wild game birds.  
6. Part V lays down the animal health requirements for the entry int o the Union, as well 
as the movement and handling after the entry , and derogations from those 
requirements for the following species of aquatic animals at all life stages as well as  
their products of animal origin , other than  wild aquatic animals and produ cts of 
animal origin from those wild aquatic animals landed from fishing vessels for direct 
human consumption :  
EN 15  EN (a) fish of listed species belonging to the superclass Agnatha  and to the classes 
Chondrichthyes, Sarcopterygii  and Actinopterygii ; 
(b) aquatic molluscs of listed species belonging to the phylum Mollusca ;  
(c) aquatic  crustaceans of listed species belonging to the subphylum Crustacea ;  
(d) aquatic animals of species listed in Annex 29  which are susceptible to the 
aquatic diseases for which certain Member States ha ve national measures to 
limit the impact of diseases other than listed diseases, as provided for in Article 
226 of  Regulation (EU) 2016/429.  
7. Part VI lays down the general rules, certain  derogations and additional requirements 
for transit through the Un ion and for the return to the Union of certain  species and 
categories of animals, germinal products and prod ucts of animal origin . 
8. Part VII lays down the transitional and final provisions.  
Article 2  
Definitions  
For the purposes of this Regulation, the definitions laid down in Regulation (EU) 2018/1882 
and Annex I to Regulation (EC) 853/2004  shall apply , except where those definitions cover 
terms that are defined in the second paragraph of this Article .  
In addition, the following definitions shall also apply:  
(1) ‘listed third country, territory or zone thereof’  means a third country, territory or 
zone thereof included in a list of third countries, territories or zones thereof from 
which the entry into the Union of specific species and categories of anim als, 
germinal products and products of animal origin is permitted in accordance with 
implementing acts adop ted accordance with Article 230 (1) of Regulation (EU) 
2016/429 ; 
(2) ‘the list’  means  the list of third countries, territories or zones thereof authorised  for 
the entry  into the Union of consignments of a particular species and  category of 
animals, germinal products or products of animal origin  by implementing acts 
adopted in accordance with Article 230 (1) of Regulation (EU) 2016/429 ; 
(3) ‘sanitary group’ means a group of listed third countries in which common animal 
health risks as regards diseases listed for equi ne animals prevail that require specific 
mitigating measures and health guarantees when equine animals enter into the Union.   
(4) 'means of transport' means road or rail vehicle, vessels and aircrafts;  
(5) ‘container’ means any crate, box, receptacle or other rigid structure used for the 
transport of animals or eggs which is not the means of transport;  
(6) 'bovine animal' means an animal of the species of ungulates belonging to the genera 
Bison , Bos (including the subgenera Bos, Bibos , Novibos , Poephagus ) and Bubalus  
(including the subgenus Anoa ) and the offspring of crossings of those species;  
(7) 'ovine animal' means an animal of the species of ung ulates belonging to the genus 
Ovis and the offspring of crossings of those species;  
(8) 'caprine animal' means an animal of the species of ungulates belonging to the genus 
Capra  and the offspring of crossings of those species;   
EN 16  EN (9) 'porcine animal' means an animal of the species of ungulates belonging to the family 
Suidae ; 
(10) 'equine animal' means an animal of species of solipeds belonging to the genus Equus  
(including horses, asses, and zebras) and the offspring of crossings of those species;  
(11) 'camelid animal' means an animal of the species of ungulates belonging to the family 
Camelidae ; 
(12) 'cervid animal' means an animal of the species of ungulates belonging to the family 
Cervidae ; 
(13) 'honeybee' means an animals of the Apis mellifera  species;  
(14) 'bumble  bee' means an animal of the species belonging to the genus Bombus ; 
(15) 'dog' means a kept animal of the Canis lupus  species;  
(16) 'cat' means a kept animal of the Felis silvestris  species;  
(17) 'ferret' means a kept animal of the Mustela putorius furo  species;  
(18) 'flock' means all poultry or captive birds of the same health status kept on the same 
premises or in the same enclosure and constituting a single epidemiological unit; in 
housed poultry includes all birds sharing the same airspace.  
(19) ‘animals intended for slaughter’  means kept terrestrial animals to be transported, 
either directly or after undergoing an assembly operation, to a slaughterhouse;  
(20) 'breeding poultry' means poultry 72 hours old or more, intended for the production of 
hatching eggs;  
(21) ‘productive poultry’ mea ns poultry 72 hours old or more, reared for the production of 
meat, eggs for consumption or other products or for restocking supplies of game 
birds;  
(22) 'day-old chicks' means poultry less than 72 hours old;  
(23) ‘specified pathogen -free eggs’ means hatching eggs d erived from ‘chicken flocks 
free from specified pathogens’, as described in the European Pharmacopoeia and 
which are intended solely for diagnostic, research or pharmaceutical use;  
(24) ‘racing pigeon’ means any pigeon transported or intended for transport from  its 
pigeon house to another Member State in order to be released to fly back to the 
Member State of origin;  
(25) 'registered equine animal’ means:  
(a) a purebred breeding animal of the species Equus  caballus  and Equus  asinus  
entered or eligible for entry in th e main section of a breeding book established 
by a breed society or breeding body recogn ised in accordance with Article  4 or 
34 of Regulation (EU) 2016/1012;  
(b) a kept animal of the species Equus  caballus  registered with an international 
association or organisation, either directly or through its national federation or 
branches, which manages horses for competition or racing  (‘registered horse’) ; 
(26) ‘consignment of semen, oocytes  or embryos ’ or ‘consignment o f germinal products ’ 
means a quantity of semen, oocytes , in vivo  derived embryos or in vitro  produced 
embryos dispatched from a single approved germinal product establishment covered 
by a single animal health certificate;   
EN 17  EN (27) ‘semen’ means the ejaculate of an animal or animals, either in the unaltered state or 
prepared or diluted;  
(28) ‘oocytes’ means  the haploid stages of the ootidogenesis including secondary oocytes 
and ova;  
(29) ‘embryo’ means the initial stage of development of an an imal while it is capable of 
being transferred to a recipient dam;  
(30) ‘approved germinal product establishment’ means a semen collection centre, an 
embryo collection team, an embryo production team, a germinal product processing 
establishment or a  germinal pro duct storage centre ;  
(31) 'unique approval number' means a number assign ed by the competent authority ; 
(32) ‘centre veterinarian’ means the veterinarian responsible for the activities carried out 
at the semen collection centre,  at the germinal product processing establishment or at 
the germinal product storage centre as provided for  in this Regulation;  
(33) ‘team veterinarian’ means the veterinarian responsible for the activities carried out 
by an embryo collection team or by an embryo produ ction team as provided for  in 
this Regulation;   
(34) ‘quarantine accommodation’ means a facility authorised by the competent authority 
for the purpose of the isolation of bovine, porcine, ovine or caprine animals for a 
period of at least 28 days before they are  admitted to a semen collection centre;  
(35) ‘semen collection centre’ means a germinal product establishment approved  by the 
competent authority for the collection, processing, storage and transport of semen of 
bovine, porcine, ovine, caprine or equine animals  intended for entry into the Union ; 
(36) ‘embryo collection team’ means a germinal product establishment comprised of a 
group of professionals or structure approved by the competent authority for the 
collection, processing, storage and transport of in vivo  derived embryos intended for 
entry into the Union;  
(37) ‘embryo production team’ means a germinal product establishment comprised of a 
group of professionals or structure approved by the competent authority for the 
collection, processing, storage and transport of o ocytes, and the in vitro  production, 
where applicable with stored semen, processing, storage and transport of embryos, 
both intended for entry into the Union;  
(38) ‘germinal product processing establishment’ means a germinal product establishment 
approved by the competent authority for the processing, including semen sex -sorting 
where appropriate, and the storage of semen, oocytes or embryos of one or more 
species, o r any combination of those types of germinal products or species, intended 
for entry into the Union;  
(39) ‘germinal product storage center ’ means a germinal product establishment approved 
by the competent authority for the storage of semen, oocytes or embryos of one or 
more species, or any combination of those types of germinal products  or species, 
intended for entry into the Union;  
(40) 'meat' means all parts of ungulates, poultry and wild game birds  which are suitable 
for human consumption;    
EN 18  EN (41) 'fresh meat' means mea t, minced meat and meat preparations, including vacuum -
wrapped or wrapped in a controlled atmosphere, which has not undergone any 
preserving process other than chilling, freezing or quick -freezing;  
(42) 'carcass of an ungulate' means the whole body of a slaught ered or killed ungulate  
after: 
(a) bleeding, in the case of slaughter ed animals ;  
(b) evisceration ;  
(c) removal of the  limbs at the carpus and tarsus ;  
(d) removal of  the tail, the udder , the head and the skin, except in porcine animals.   
(43) 'offal' means fr esh meat other than that of a carcass of an ungulate  even if it remains 
naturally connected to the carcass;  
(44) 'meat products' means processed products, including stomachs, bladders, intestines,  
rendered fats, meat extracts  and blood products, resulting from the processing of 
meat or from the further processing of such processed products, so that the cut 
surface shows that the product no longer has the characteristics of fresh meat;  
(45) 'casings' means the bladders and intestines that after cleaning have been proc essed by 
tissue scraping, defatting and washing and have been treated with salt or dried;  
(46) 'colostrum' means the fluid secreted by the mammary glands of kept animals up to 
three to five days post parturition that is rich in antibodies and minerals, and prec edes 
the production of raw milk ;  
(47) 'colostrum -based products' means processed products resulting from the processing 
of colostrum or from the further processing of such processed products;  
(48) ‘well -boat’ means a vessel used by the aquaculture industry which ha s a well or tank 
for the storage and transport of live fish in water ; 
(49) ‘IMSOC ’ means the information management system for official controls provided 
for in Article 136 of Regulation (EU) No 2017/625 . 
TITLE 2 
GENERAL ANIMAL HEALTH  REQUIREMENTS FOR THE ENTRY INTO THE 
UNION , AND MOVEMENT AND HANDLIN G AFTER THE ENTRY  OF 
CONSIGNMENTS  OF ANIMALS , GERMINAL PRODUCTS AN D PRODUCTS 
OF ANIMAL ORIGIN  
Article 3  
Obligations of the competent authorities  of Member States  
1. The competent authority shall permit the entry into the Union of consignments of 
animals, germinal products and products of animal origin of species and categories 
falling within the scope of  this Regulation, which are presented for the purpose of 
official  control s as provided for in Article 47( 1) of Regulation (EU) 2017/625,  
provided that :  
(a) the consignments come from:   
EN 19  EN (i) in the case of terrestrial animals, a listed third country  or territory or zone 
thereof for the particular species and category  of anima ls, germinal 
products and products of animal origin ;  
(ii) in the case of aquatic animals, a listed third country or territory or zone 
thereof for the particular species and  category of animals, germinal 
products and products of animal origin , and in the c ase of aqua culture  
animals, a compartment listed for  that purpose .  
(b) the competent authority of the third country or territory of origin has certified 
that the consignments comply with : 
(i) the general animal health requirements for the entry into the Union of 
animals, germinal products and products of animal origin laid down in 
this Article , Article  4 and Articles  6 to 10;  
(ii) the animal health requirements  applicable to the particular spe cies and  
category of animals, germinal products and products of animal origin  and 
intended use, as laid down in Parts II to VI ; 
(c) the consignments are accompanied by the following documents where by the 
competent authority of the third country or territory of  origin has provid ed the 
necessary guarantees as regards compliance with the animal health 
requirements referred to in point (b):  
(i) an animal health  certificate  issued by an official veterinarian of the third 
country or territory of origin , specific for the particular  species and 
category of animals, germinal products and products of animal origin  and 
their intended use;  
(ii) a declaration and other documents , where required  in this Regulation . 
In the case of consignments of animals and germinal products , the animal 
health certificate, referred to in point (c)(i) must have been issued  within the 
period of 10 days before the date of arrival  of the consignment at the border 
control post ; however, in the case of transport by sea that period may be 
extended by an additional period  corresponding to the duration of the journey 
by sea. 
Article 4 
The date of certification  of consignments  
1. Consignments of animals, germinal products and products of animal origin of species 
and categories falling within the scope  of this Regulation shall only be permitted to 
enter the Union provided that such consi gnments were  certified for dispatch  to the 
Union not earlier than the date on which the third country or  territory of origin or 
zone  thereof, or compartment thereof in the case of aquaculture  animals, was listed 
for the entry into the Union of the particular species and  category of animals, 
germinal products and products of animal origin .  
2. Consignments of animals  and hatching eggs  originating from a third country  or 
territory or zone  thereof , or compartment thereof in the case of aquaculture animals , 
shall not be permitted to enter the Union  from the date on which it no longer 
complies with the animal health requirements for the entry into the Union of the 
specific species and category of animals  and hatching eggs .   
EN 20  EN Article 5 
Obligations of operators  
1. Operators responsible for the entry into the Union of consignments of animals, 
germinal products and products of animal origin of the species and catego ries falling 
within the scope of  this Regulation, shall present those  consignments to the 
competent authority in the Union  for the purpose of official control s, as provided for 
in Article 47(1) of Regulation (EU) 2017/425 , and shall ensure that such 
consignments comply with the following  requirements :  
(a) the general animal health requirements for the entry into the Union of the 
animals, germinal products and products of animal origin laid down in Article s 
3 and 4 and Articles 6 to 10;  
(b) the animal health requirements applicable to the particular species and category 
of the animals, germinal products and products of animal origin  of the  
consignment and its intended use, as laid down in Parts II to VI . 
2. Operators responsible for the movement of consignments of animals,  germinal 
products and products of animal origin of species and categories falling within in the 
scope of this Regulation  from the point of  arrival in the Union to their place of 
destination , and those responsible f or the handling of such consignment s after their 
entry into the Union shall ensure that  the consignments : 
(a) comply with the requirements of Article 3, so that the competent authority may 
permit the entry of the consignments into the Union;   
(b) comply with the animal health requirements for the mov ement and handling  of 
such consignments after the entry into the Union for the specific species and 
categories of animals, germinal products and products of animal ori gin laid 
down in Parts II to VI ;  
(c) are not diverted for uses  other than those for which th ey were certified  by the 
competent authority of the third country or territory of origin for the entry into 
the Union . 
Article 6 
National legislation and animal health systems of the third country or territory  of origin  
1. Consignments of a nimals, germinal products and products of animal origin shall only 
be permitted to enter the Union from a third country or territory where:  
(a) any suspicion  or case of a listed disease  referred to in Annex 1, which are 
relevant for the listed species in the consignment or for the listed species of 
origin of the germinal products or products of animal origin authorised to enter 
the Union, are required by law to be notified and reported to the competent 
authority ;  
(b) there are systems in place to detect, identify , control an d eradicate emerging 
diseases;  
(c) there are systems in place to ensure that swill feeding  is not a source of the 
listed diseases referred to in Annex 1 for : 
(i) the animals intended for entry into the Union ; or 
(ii) the animals of origin of the g erminal products or the products of animal 
origin intended for entry into the Union.   
EN 21  EN 2. Consignments of a nimals, germinal products and products of animal origin intended 
for entry into the Union shall only be permitted  to enter the Union from a third 
country or territory  or zone thereof  where such consignment s may be lawfully placed 
on the market and traded in that third country or territory of origin  or zone thereof . 
Article 7 
General requirements as regards the health status of the animals, germinal products and 
products of animal origin  
1. Consignments of a nimals  shall only be permitted to enter the Union if the animals : 
(a) are not animals to be killed under a national programme  in the third country or 
territory of origin  for the eradication of dis eases, including the relevant listed 
diseases referred to in Annex I and emerging diseases ; 
(b) did not show clinical signs of transmissible diseases at the time of loading for 
the dispatch  to the Union;  
(c) originate from an establishment which, at the t ime of their dispatch from that 
establishment for dispatch  to the Union, was not subject to national restriction 
measures : 
(i) for animal health reasons ; or  
(ii) due to the occurrence of increased mortality, including cases of listed 
diseases referred to in Annex 1 and emerging diseases.  
2. Consignments of g erminal products shall  only be permitted to enter the Union if they 
were obtained from donor animals which at the time of collection:  
(a) did not show clinical signs of transmissible diseases;  
(b) were kept on an establishment which was not subject to national restriction 
measures for animal health reasons, including restrictions related to the 
relevant listed diseases referred to in Annex 1 and emerging diseases.   
3. Consignments of products of ani mal origin shall only be permitted to enter the Union 
if they were obtained from animals which:  
(a) in the case of terrestrial animals, did not show clinical signs of transmissible 
diseases at the time of:  
(i) killing or slaughter, for the production of fresh meat and meat products; 
or 
(ii) the collection of milk or eggs.  
(b) in the case of aquatic animals, did not show clinical signs of transmissible 
diseases at the time of:  
(i) slaughter for the production of products  of animal origin ; or 
(ii) the collection or p acking of molluscs  and live crustaceans  intended for 
human consumption.  
(c) in the case of the animals referred to in  points (a) and (b), were not killed, 
slaughtered or, in the case of molluscs and live crustaceans removed from the 
water, under a national pro gramme for the eradication of diseases;   
EN 22  EN (d) were kept on an establishment which was not subject to national restriction 
measures for animal health reasons, including where relevant , listed diseases 
referred to in Annex 1 and emerging diseases, at the time of:  
(i) the killing or slaughter of those animals for the production of fresh meat 
and meat products or products of animal origin from aquatic animals ; or  
(ii) the collection of milk and eggs.  
Article 8 
General requirements as regards t he establishment of o rigin of the animals  
In addition to the specific requirements laid down  in Parts II to V , consignments of animals, 
germinal products and products of animal origin shall only be permitted to enter the Union if 
the establishment of origin of the animals , or the establishment of origin of the animals from 
which the germinal products or products of animal origin were obtained , complies with the 
following requirements : 
(a) it must be registered by the competent authority of the third country or territory of 
origin;  
(b) it must be approved, where required  by this Regulation , by the competent authority 
of the third country or territory of origin;  
(c) it must be under the control of the competent authority of the third country or 
territory of origin;  
(d) it must have a system in place to maintain and to keep, for a minimum period of 
three years, up -to-date records containing at least the following information:  
(i) the species, categor ies, number and where relevant, identification of animals on 
the establishment;  
(ii) movements of animals into and out of the establishment;  
(iii) mortality in the establishment.  
(e) it must receive regular animal health visits from a veterinarian for th e purpose of the 
detection of, and information on, signs indicative of the occurrence of diseases, 
including those listed diseases referred to in Annex 1 relevant  for the particular 
species and category of animal, germinal product or product of animal orig in and 
emerging diseases.  
Article 9 
Sampling, laboratory tests and other tests  
Consignments of animals, germinal products and products of animal origin shall only be 
permitted to enter the Union if s ampling, laboratory tests and other tests required by this 
Regulation have been carried out:   
(a) on samples taken by or under the control of the competent authority  of: 
(i) the third country or territory of origin when sampling and testing are required 
prior to entry into the Union; or 
(ii) the Member State of destination when sampling and testing  are required after 
the entry into the Union;  
(b) in accordance with:   
EN 23  EN (i) the relevant procedures and methods set out in Regulation (EU) 2019/…  as 
regards rules for surveillance, eradication programmes, and disease -free 
status for certain listed and emerging diseases  [document  C(2019)4056 ]; 
(ii) for the purpose of entry into the Union of germinal products of bovine, porcine, 
ovine, caprine and eq uine animals, the procedures and methods set out in 
Annex II to Regulation (EU) 2019/…  as regards the approval of germinal 
product establishments and the traceability and animal health requirements for 
movements within the Union of germinal products of cer tain kept terrestrial 
animals  [document C(2019)4055 ]; or 
(iii) the procedures described in this Regulation, where specifically required . 
(c) in an official laboratory , as defined in Regulation (EU) 2017/425 . 
Article 10 
Disease  freedom  of the place of origi n and specific conditions  
1. Consignments of animals, germinal products and products of animal origin shall only 
be permitted to enter the Union if the freedom  from particular diseases  of the third 
country  or territory  of origin or  zone thereof or of the establishment of origin of the 
animals, germinal products or products of animal origin , required by this Regulation 
have been  demonstrated by the competent authority of the third country or territory 
of origin:  
(a) in accordance with Regulation (EU) 2019/…  as regards rules for surveillance, 
eradication programmes, and disease -free status for certain listed and 
emerging diseases  [document  C(2019)4056] ; or 
(b) for diseases not falling within the scope of  Regulation (EU) 2019/…  as regards 
rules for surveillance, e radication programmes, and disease -free status for 
certain listed and emerging diseases  [document C(2019)4056] , in accordance 
with the disease surveillance programme implemented by the third country or 
territory of origin, which must have been : 
(i) submitt ed to the Commission for assessment and contain at least the 
information referred to in Annex 2;  
(ii) assessed by the Commission  as providing the necessary guarantees as 
regards disease  freedom  based on:  
– the rules on disease surveillance laid down in Artic les 24, 25, 26 
and 27 of Regulation (EU) 2016/429;  
– the supplementing rules on surveillance design and the rules for 
disease confirmation and case definition laid down in Section s 1 
and 2 and Article 10 of Chapter 1  of Part II of Regulation (EU) 
2019/…  as regards rules for surveillance, eradication 
programmes, and disease -free status for certain listed and 
emerging diseases  [document C(2019)4056] . 
(iii) in place  for a sufficient period of time for it to be fully implemented and 
properly supervised . 
2. In th e case of aquaculture animals and products of animal origin from aquaculture 
animals, where disease  freedom  from particular diseases is required for the 
compartment of origin , consignments of those commodities shall only be permitted  
EN 24  EN to enter the Union if the competent authority of the third country of origin  has 
demonstrated disease  freedom  in accordance wit h paragraph  1(a) and (b).  
3. Where specific conditions related to the disease freedom from particular diseases of 
the third country or territory of or igin, or zone thereof,  are required in this 
Regulation:  
(a) the competent authority of the third country or territory of origin  must have  
previously  guaranteed its compliance ;  
(b) they shall have been specifi cally assigned by the Union  in the list,  to the third 
country or territory or zone thereof listed  for the entry into the Union of the 
specific species and category of animals, germinal products and products of 
animal origin . 
PART II  
ANIMAL HEALTH REQUIR EMENTS FOR THE ENTRY  
INTO THE UNION OF KE PT TER RESTRIAL ANIMALS  AS 
REFERRED TO IN ARTIC LES 3 AND 5  
TITLE  1 
GENERAL  ANIMAL  HEALTH  REQUIREMENTS  FOR  KEPT  
TERRESTRIAL  ANIMALS   
Article 11 
The residency period required for kept terrestrial animals  
Consignments of kept terrestrial animals  other than  dogs, cats and ferrets,  shall only be 
permitted to  enter the Union subject to compliance with the following requirements : 
(a) the animals complied with the relevant residency period set out in the following 
tables of Annex 3 for a continuous period of time  immed iately prior to the date of 
dispatch to the Union:  
(i) Table 1 in the case of ungulates, honeybees and bumble bees ;  
(ii) Table 2 in the case of poultry and captive birds.  
(b) during the residency period s referred to in point (a) , the animals:  
(i) remaine d continuously in the third country or territory of origin or zone 
thereof;  
(ii) remained continuously in the establishment of origin, and no animals were 
introduced into that establishment during that period;  
(iii) had no contact with animals of a lower  health status.  
Article 1 2 
Derogations regarding the residency period for registered  horses for competition, races and 
cultural events  
1. By way of derogation of point ( b)(i) of Article 11, registered horses for competition  
and races shall be regarded as c omplying with the residency period provided for in 
Table 1 of Annex 3, if they have been  resident during the period indicated in Table 1 
of Annex 3 prior to their dispatch  in:  
EN 25  EN (a) a Member State;  or  
(b) a listed third countr y, territor y of intermediate residency, or zone thereof, from 
where the entry into the Union of registered horses is authorised for that 
purpose and provided that they were introduced into the third country or 
territory of origin, or zone thereof, in accordance with animal health 
requirements providing animal health guarantees at least as stringent as those 
applicable to the direct entry into the Union of registered horses for 
competition and races from that third country or territory of intermediate 
residence, or zone thereof . 
2. By w ay of derogation from  point (b) (ii) of Article 11, registered horses for 
competition, races and cultural events shall  be regarded as  comply ing with  the 
residency period provided for in Table 1 of Annex 3 if they were resident in 
establishments other than t he establishment of origin provided that the other  
establishment s:  
(a) have been under supervision of the official veterinarian in a third country or 
territory ; 
(b) were not subject to national restriction measures for animal health reasons, 
including restrictions relating to the relevant diseases referred to in Annex 1 
and relevant emerging diseases ;  
(c) compl y with the animal health requirements laid down in Article 2 3. 
3. Also b y way of derogation from  point (b)(ii) of Article 11 , registered horses for 
competition, races and cultural events  that have had contact with equine animals  
which were entered into the third country, territory  or zone thereof  from another third 
country territory, or zone thereof, or from another zone in the third country or 
territ ory of origin shall be permitted to enter the Union provided that : 
(a) those equine animals  were introduced into the third country or territory of 
origin or zone thereof in accordance with animal health requirements  at least as 
stringent  as those applicable to  the direct entry into the Union of those equine 
animals;  
(b) the possibility of direct contact with other animals is limited to the period of 
the competition,  races or cultural events  and the related training, warm -up and  
pre-racing  presentation.  
Article 1 3 
Inspection of terrestrial animals prior to dispatch  to the Union  
1. Consignments of t errestrial animals shall only be permitted to enter the Union if the 
animals have been subjected to a clinical inspection, carried out by an official 
veterinarian in the t hird country or territory of origin or zone thereof within the 
period of 24 hours prior to the time of loading for dispatch to the Union for the 
purpose of the detection of signs indicative of the occurrence of diseases, including 
the relevant listed disea ses referred to  in Annex 1 and emerging diseases.  
In the case of poultry and captive birds, th at inspection shall cover both the animals 
intended for dispatch to the Union and the flock  of origin.   
EN 26  EN 2. By way of derogation from  the first subparagraph of paragraph 1, in the case of dogs, 
cats and ferrets the inspection referred to there in may be carried out within the period 
of 48 hours prior to the time of loading for dispatch to the Union . 
Article 1 4 
General rules for the dispatch to the Union of terrestrial  animals  
1. Consignments of t errestrial animals shall only be permitted to enter the Union  if, 
from the time of loading at the establishment of origin for dispatch to the Union until 
the time of their arrival in the Union, the terrestrial animals have not been in contact 
with other terrestrial animals  of: 
(a) the same species, not intended for the entry into the Union ; 
(b) other species listed for the same diseases , not intended for the entry into the 
Union ;  
(c) a lower health status.  
2. When transported by air, sea, railway, road  or on foot, the consignments referred to 
in paragraph 1 shall only be permitted to enter the Union if they have  not been 
transported through, unloaded or transhipped in a third country or territory or zone 
thereof which is not listed for the entry into the Union of the specific species  and 
category of animals and intended use into the Union.  
3. When transported by sea, even for part of the journey, the consignments referred to 
in paragraph 1 shall only be permitted to enter the U nion if they arrive to the Union 
accompanied by a declaration, attached to the animal health certificate accompanying 
the animals and signed by the master of the vessel , providing the following 
information:  
(a) the port of departure in the third country  or territory of origin or zone  thereof ; 
(b) the port of arrival in the Union;  
(c) the ports of call, where the vessel called at ports outside the third country  or 
territory of origin or zone thereof of the animals;  
(d) evidence of compliance with the followi ng requirements  during the journey to 
the Union :  
(i) the animals have remained on board;  
(ii) the animals have not been into contact with animals of a lower health 
status while on board.  
Article 1 5 
Derogation for  the transhipment of terrestrial animals  except equine animals  in non -listed  
third countries or territories in the event of a technical problem or another unforeseen 
incident   
1. By way of derogation from Article 14 (2), the competent authority shall  authorise the 
entry into the Union of consignmen ts of terrestrial animals , except equine animals , 
which have been transhipped from the original means of transport of dispatch into 
another means of transport for onward travel in a third country or territory or zone 
thereof which is not a listed third country, territory or zone thereof for the entry of 
the particular species and  category of animals into the Union, only if the  
EN 27  EN transhipment operation took place because of the occurrence of a technical problem 
or another unforeseen incident causing l ogistic problems during the transport of the 
animals to the Union by sea or by air, in order to complete the transport to the point 
of entry into Union, provided that:  
(a) the entry into the Union of the animals is authorised by the competent authority 
of the Member State of destination and, where applicable , any Member States 
of passage  until their arrival at their place of destination  in the Union ; 
(b) the transhipment was supervised by an official veterinarian in a third country or 
territory throughout the opera tion to ensure that : 
(i) effective protection measures against  vectors of relevant animal diseases 
were provided;  
(ii) effective measures were put in place to avoid direct and indirect contact 
between the animals intended for entry into the Union and any other 
animals;  
(iii) no feed, water or bedding, originating from a third country or territory or 
zone thereof which is not a listed  third country, territory or zone thereof 
for the entry of the particular species and  category of animals into the 
Union, has  been added in the means of transport for onward travel  to the 
Union ; 
(iv) the animals were transferred directly and as quick as possible to a vessel 
or aircraft for onward travel  to the Union , which complies with 
requirements laid down in Article 17 , without leaving the boundaries  of 
the port or airport ;  
(c) the consignment of animals is accompanied by a declaration from the 
competent authority of the third country o r territory where the transfer took 
place , providing information on the transfer operati on and attesting th at 
relevant measures were put in place to comply with the requirements laid down 
in point (b) .  
2. The d erogation provided for in paragraph 1 shall not apply to consignments of 
honeybees and bumble bees . 
Article 1 6 
Derogation for  the transhipment of equine animals in non -listed  third countries or territories  
By way of derogation from Article 1 4(2), where  consignments of equine animals have been 
transhipped to another means of transport during the transport of the animals  to the Union  in a 
third country or territory or zone thereof which is not a listed  third country, territory or zone 
thereof for the entry of the particular category of equine animals , those consignments shall 
only be permitted to enter the Union  if they comply with the following requirements :  
(a) the animals were transported to the Union by sea or by air ; 
(b) they were  transhipped directly from the original means of transport of dispatch  into 
the other means of transport for onward travel ; 
(c) during the transhipment op eration:  
(i) effective protection against vectors of relevant animal diseases were provided 
and the equine animals did not come into contact with equine animals of a 
lower health status;    
EN 28  EN (ii) the equine animals were transferred directly and as quick as p ossible to the 
vessel or aircraft to be used for onward travel, which must have complie d with 
requirements laid down in Article 17 , without leaving the boundaries  of the 
port or airport under the direct supervision of an official veterinarian .  
(d) an offi cial veterinarian must have certified  that the consignment complied with the 
requirements laid down in point (a) , (b) and (c) .  
Article 1 7  
General requirements regarding means of transport of terrestrial animals  
1. Operators , including  transporters , shall ensure that the means of transport used for 
transporting consignments of kept terrestrial animals intended for entry into the 
Unio n are: 
(a) constructed in such a way that:  
(i) the animals cannot escape or fall out;  
(ii) visual inspection of the spa ce where animals are kept is possible;  
(iii) the escape of animal excrements, litter  or feed is prevented or minimi sed; 
(iv) in the case of poultry and captive birds, the escape of feathers is 
prevented or minimi sed. 
(b) cleaned and disinfected, with a dis infectant authorised by the competent 
authority of the third country or territory of dispatch, immediately  before  every 
transport ation  of animals or any item representing an animal health risk, and, if 
necessary, disinfected again and in any case dried or allowed to dry before any 
new loading of animals.  
2. Paragraph 1 shall not apply to the transport of consignments of honeybees and 
bumble bees  intended for the entry into the Union. See comment at Article 19 . 
Article 1 8 
Requirements regarding containers in  which terrestrial animals are transported  to the Union  
Operators shall ensure that containers in which kept terrestrial animals are transported to the 
Union  in the means of transport:  
(a) comply with the requirements in Article II.1.1 -1(a) of Commission D elegated 
Regulation (EU) 2019/…  as regards animal health requirements for movements 
within the Union of terrestrial animals and hatching eggs  [document C(2019)4058 ]; 
(b) contain only animals of the same species  and category coming from the same 
establishme nt; 
(c) are either : 
(i) single use  purpose -designed disposable containers to be destroyed after first 
use; or 
(ii) cleaned and disinfected after each use and dried before subsequent use.   
EN 29  EN Article 19 
Movement and handling after the  entry of terrestrial anima ls 
1. Following their entry into the Union, consignments of terrestrial animals  shall  be 
transported directly without delay to:  
(a) their establishment of destination  in the Union , where  they shall remain at least 
for the period of time required in the relevant specific articles in Parts II to V;  
(b) the slaughterhouse of destination  in the Union , if they are intended for 
slaughter, and they must be slaughtered within  a period of  five da ys from the 
date of their arrival in the Union.  
2. Where the destination of the consignments of terrestrial animals entered from a third 
country, territory or zone thereof  is a slaughterhouse, an approved quarantine 
establishment  or a confined establishmen t in the Union , the transport to and arrival at 
the place of the destination of the consignment shall be monitored  in accordance with 
Article 2 and 3 of Commission Delegated Regulation (EU) 2019 /… reference to 
SANTE/7146/2018 . 
TITLE  2 
ANIMAL  HEALTH  REQUIREMENTS  FOR  UNGULATES  
Chapter 1  
Specific animal health requirements for ungulates  
Article 20 
Dispatch of ungulates to the Union  
1. Consignments of ungulates shall only be permitted to enter the Union if such 
consignments have been  dispatched directly  from the establishment of origin to the 
border control post of first arrival in the Union.  
2. By way of derogation of paragraph 1, consignments of ungulates coming from more 
than one establishment of origin may be permitted to enter the Union if they have  
undergone a single assembly operation in the third country  or territory of origin or 
zone thereof subject to compliance with the following conditions : 
(a) the ungulates belong to one of the following species and categories:  
(i) Bos taurus , Ovis aries , Capra hircus , Sus scrofa ; or  
(ii) Equidae intended for slaughter;  
(b) the assembly operation took place in an establishment:  
(i) approved for conducting assembly operations of ungulates by the 
competent authority in the third country or territory in accordance with 
Article 5 of Regulation (EU) 2019/…  as regards rules for establishments 
keeping terrestrial animals and hatcheries, and the traceability of certain 
kept terrestrial animals and hatching eggs  [document SANTE 
7016/2018 ];.  
(ii) which has  an approval number assigned by the competent authority of the 
third country or territory;   
EN 30  EN (iii) listed for that purpose by the competent authority of the third country or 
territory of dispatch , including the information provided  for in Article 21 
of Regul ation (EU) 2019/…  as regards rules for establishments keeping 
terrestrial animals and hatcheries, and the traceability of certain kept 
terrestrial animals and hatching eggs  [document SANTE 7016/2018 ]; 
(iv) where the following records are kept up -to-date fo r a period of at least 
three years:  
– the origin of the animals;  
– the dates of arrival and dispatch to and from the assembly centre;  
– the identification number of the animals;  
– the registration number of the establishment of origin of the 
animals;  
– the regi stration number of the transporters and the means of 
transport delivering or collecting the consignment of ungulates to 
and from that centre.  
(v) which complies with the requirements provided for in Article 8 and 
Article 2 3(1). 
(c) the assembly operation in the assembly centre took no longer than 6 days, 
which shall be taken into account when sampling for testing before dispatch to 
the Union is required  by this Regulation ; 
(d) the ungulates must have arrive d in the Union within a period of 10 days from 
the date of dispatch from  the establishment of origin.  
Article 21 
Identification of ungulates  
1. Consignments of ungulates , other than equine animals , shall only be permitted to 
enter the Union if the ungulates were  individually identified before being dispatc hed 
from the establishment  of origin, by  a physical means of identification  with a visible, 
legible and indelible display of : 
(a) the identification code of the animal which establishes an unequivocal link 
between the animal and the accompanying animal hea lth certificate ;  
(b) the code of the exporting country conformance  with ISO Standard 3166 in the 
format of two -letter code.  
2. Consignments of e quine animals  shall only be permitted to enter the Union if those 
animals are individually identified  by: 
(d) an in jectable transponder or an alternative method of identification which 
ensures an unequivocal link between the animal and its accompanying entry 
documentation;  
(e) an identification document, issued at the latest at the time of certification for 
entry into the  Union, which describes and depicts the animal so as to link it to 
the certificate, and contains information on the individual code emitted by the 
implanted transponder or the alternative method of identification referred to in 
point (a).    
EN 31  EN 3. Where ungulat es are identified with an electronic identifier which does not comply 
with ISO Standards 11784 and 11785  the operator responsible for the entry into the 
Union of the consignments of ungulates shall provide the reading device which 
enables at any time the verification of the identification of the animal.  
Article 22  
The third country  or territory of origin of ungulates or zone  thereof   
1. Consignments of u ngulates , other than equine animals , shall only be permitted to 
enter the Un ion if those  animals origin ate from a third country  or territory or zone 
thereof free from the category A  diseases referred to in the table set out in point 1 of 
Part A of Annex 4 , and for the period referred to in that table . 
2. Consignments of e quine animals  shall only be permi tted to enter the Union if  those 
animals originate from a third country  or territory or zone thereof:  
(a) free from the listed diseases referred in the table set out in point 2 of Part A of 
Annex 4 , and for the period referred to in that table ;  
(b) where none of  the listed diseases referred to  in the table set out in point 3 of 
Part A of Annex 4 has been reported  during the referred period .  
3. The periods referred to in paragraph 1 and 2 may be reduced for diseases included in 
Part B of Annex 4 under the  relevant specific conditions  referred therein.   
4. Consignments of u ngulates shall only be permitted to enter the Union if those 
animals originate from a third country  or territory or zone thereof  where  vaccination 
against the category A  diseases referred to in Part C of Annex 4 has not been carried 
out in accordance with the details set out  in:  
(a) point 1 of that Annex in the case of ungulates , other than equine animals;  
(b) point 2 of that Annex in the case of  equine animals . 
5. As regards infection s with Myco bacterium tuberculosis complex  (M. bovis, M. 
caprae, M. tuberculosis ), consignments of  bovine animals shall  only be permitted to 
enter the Union if those animals either : 
(a) originate from a third country or territory or zone thereof free from that disease 
without vaccination; or  
(b) comply with the requirements  set out in point 1 of Annex 5.  
6. As regards infection s with Brucella  abortus, B. melitensis and B.suis , consignments 
of bovine, ovine and caprine animals shall  only be permitted to enter the Union if 
those animals either : 
(a) originate from a third country or territory or zone thereof free from that disease 
without vaccination; or  
(b) comply with the requirements  set out in point 2 of Part A of Annex 5. 
7. As regards infection with bluetongue virus ( serotypes 1 -24), consignments of 
ungulates of listed species shall  only be permitted to enter the Union if those animals 
originate either : 
(a) from a third country or territory or zone thereof free from that disease for a 
period  of 2 years prior to the date of dispatch to the Union ; or  
(b) comply with one of the specific conditions set out in of Part A of Annex 6 .  
EN 32  EN 8. As regards enzootic bovine leukosis , consignments of ungulates shall  only be 
permitted to enter the Union if those an imals either : 
(a) originate from a third country or territory or zone thereof free from that 
disease; or  
(b) comply with the specific conditions set out in Part B of Annex 6. 
9. Consignments of u ngulates intende d for entry into Member States or zones thereof 
with disease -free status  or with an approved eradication program me for the category 
C diseases referred to in Annex 7, for which the species of ungulates are listed, shall  
only be permitted to enter the Union if those animals :  
(a) originate from third country or territory or zone thereof  free from those 
diseases for the relevant  species ; or 
(b) comply with the relevant additional requirements set out in that Annex.  
Article 23 
The establishment of origin of ungulates  
1. Consignments of u ngulates shall only be permitted  to enter the Union if those 
animals:  
(a) come from an establishment in and around which, including where appropriate 
the territory of a neighbouring country, none of the listed diseases referred to in 
Annex 8, for which the species of ungulates intended for t he entry into the 
Union are listed, has been reported in an area and for a period set out in the 
tables in:  
(i) points 1 and 2 of that Annex for ungulates other than equine animals; or  
(ii) points 3 and 4 of that Annex for equine animals.  
(b) during the pe riod referred to in point (a)  1, the ungulates have not come into 
contact with animals with a lower health status.  
2. As regards  infection  with Mycobacterium tuberculosis complex  (M. bovis , M. 
caprae, M. tuberculosis ), consignments of bovine, caprine, camelid and cervid 
animals shall only be permitted to enter the Union if the establishment of origin of 
those animals complies  with the relevant requirements set out in point 1 of Annex 9.  
3. As regards infection with Brucella  (B. abortus , B. melitensis and B.suis ), 
consignments of bovine, ovine, caprine, porcine, camelid and cervid animals shall 
only be permitted to enter the Union if the establishment of origin of those animals 
complies  with the relevant requirements set out in point 2 of Annex 9.  
Article 24 
The ungulates of the consignment  
1. Consignments of u ngulates shall only be permitted to enter the Union if those 
animals comply with the following requirements:   
EN 33  EN (a) they have not been vaccinated against the category A  diseases referred to in the 
tables  set out either in: 
(i) point 1 of Part C of Annex 4 in the case of ungulates other than equine 
animals; or  
(ii) point 2 of Part C of Annex 4 in the case of equine animals.  
(b) during the period of time from when they were dispatched from their  
establishment of origin until their arrival to the Union, they must not have been 
unloaded in any place which do es not comply with the requirements laid down 
in the tables  set out either  in:  
(i) points 1 and 2 of Annex 8 in the case of ungulates other th an equine 
animals; or  
(ii) points 3 and 4 of Annex 8 in the case of equine animals.  
2. As regards infection with Mycobacterium tuberculosis complex  (M. bovis , M. 
caprae, M. tuberculosis ) and infection with Brucella  (B. abortus, B. melitensis and 
B.suis ) consignments of listed species of ungulates shall only be permitted to enter 
the Union if the animals  have not been vaccinated  against those diseases.  
3. As regards infection with bluetongue virus (serotypes 1 -24), consignments of listed 
species of ungulat es shall only be permitted to enter the Union if the animals  have 
not been vaccinated with a live vaccine against infection with BTV in the last 60 
days before the date of movement.  
4. Consignments of u ngulates intende d for entry into Member States or zone s thereof 
with disease -free status  or with an approved eradication program me for the category 
C diseases referred to in Annex 7, for which the species of ungulates are listed, shall  
only be permitted to enter the Union if those animals  have not been vaccin ated 
against those diseases.   
5. In addition to requirements laid down in paragraph 1, consignments of uncastrated 
males of ovine animals, porcine animals and ungulates of the family Tayassuidae  
shall only be permitted to enter the Union if those animals  comply with the relevant 
specific requirements  as regards infection with Brucella  laid down in Annex 10 . 
6. In addition to requirements laid down in paragraph 1, consignments of equine 
animals shall only be permitted to enter the Union if those animals  comply with the 
specific conditions  set out in point 2 of Annex 11 , depending on the sanitary group , 
as determined in accordance with point 1 of Annex 11,  to which the third country or 
territory or zone thereof  has been assigned  in the list.  
Article 25 
Derogations and additional requirements for  the entry into the Union of ungulates for 
slaughter  
By way of derogation from the requirements laid down in Article 2 2(5) and (6) , consignments 
of ungulates of the species referred to in those  paragraph s which do not comply with those 
requirements  shall be permitted to enter the Union provided that those animals are only 
intended for slaughter.   
EN 34  EN Article 26 
Movement and handling of ungulates after the ir entry into the Union  
Following their entry into the Union, u ngulates, except horses entering for competition,  races 
and cultural events  shall remain in their establishment of destination for a period of time of at 
least 30 days  since their arrival  to that establishment.   
Chapter 2  
Special rules for the entry into the Union of kept ungulates 
intended for confined establishments  
Article 27 
Derogations from certain animal health requirements for ungulates intended for confined 
establishments  
By way of derogation from Articles 11, 2 2, 23, 24 and 2 6, consign ments of ungulates 
intended for confined establishments shall only be permitted to enter the Union provided that  
those animals:  
(a) originate from a confined establishment in a third country or territory and are 
intended for a confined establishment in the  Union ; 
(b) comply with the additional requirements set out in Articles 28 to 35. 
The derogation provided for in the first subparagraph shall not apply to equine animals except  
zebras.  
Article 28 
Additional animal health requirements for ungulates intended  for confined establishments  
1. Consignments of ungulates intended for confined establishments only be permitted to 
enter the Union if those u ngulates  comply with the following requirements : 
(a) they must originate from a confined establishment which is included in a list of 
confined establishments from which the entry of ungulates into the Union is 
permitted , drawn up in accordance with Article 29; 
(b) they must have been dispatched  directly from the confined establishment of 
origin to a confined establishment in the Union .  
2. The competent authority of the Member State of destination  shall grant a specific 
authorisation for the entry of each consignment of ungulates , referred to in paragraph 
1, after carrying  out an assessment of the potential risks that the entry of such 
consignment may present for the Union.  
3. The entry into the Union and the movement of the ungulates destined to a confined 
establishment in the Union through Member States other than the Mem ber State of 
destination  shall be only permitted subject to the authorisation of the competent 
authorities of those Member States  of passage .  
That authorisation shall be granted only on the basis of a risk assessment carried out 
by the competent authority  of those Member States  of passage , based on the 
information submitted to them by the Member State of the place of destination  in the 
Union .  
EN 35  EN 4. The Member State of the place of destination of the consignment referred to in 
paragraph 1 shall notify the Comm ission  and the other Member States within the 
framework of the Standing Committee on Plants, Animals, Food and Feed and notify 
directly the point of arrival in the Union of the ungulates, of the authorisations 
granted pursuant to paragraph 1 and 2, prior to possible movement through other 
Member States and prior to the arrival of such ungulates into their territory.  
Article 29 
Listing of confined establishments of origin of ungulates in third countries or territories  
1. Member States may draw up a list of confined establishments in third countries and 
territories, from which the entry of ungulates into their territory shall be permitted .  
That list shall specify the species of ungulates permitted to enter  the territory of the 
Member State from each confined  establishment in the third country or territory.  
2. Member States may include in their list of confined establishments provided for in 
paragraph 1, confined establishments that are already included in such lists of other 
Member States . 
Except as provided for in the first subparagraph, Member States shall only  include a 
confined establishment in a third country or territory in the list  of confined 
establishments  provided for  in paragraph 1, after carrying out an assessment based on 
the fo llowing:  
(a) compliance by the confined establishment with the requirement to be approved 
by the competent authority of the third country or territory of origin laid down  
in Article 3 0;  
(b) the competent authority of the third country or territory of origin must  have 
provided sufficient information to guarantee that the confined establishment 
complies with the requirements concerning the approval of confined 
establishments laid down  in Article 3 0. 
3. Member States shall keep the lists of confined establishments provided for  in 
paragraph 1 up -to-date, taking into account in particular any suspension or 
withdrawal of the approval granted by the competent authority of a third country or 
territory of origin as referred to in Article 3 0, or by the competent authority of 
another Member State.  
4. Member States shall make the lists provided for  in paragraph 1 publicly available on 
their websites.  
Article 30 
 Conditions for confined establishments of origin of ungulates in third countries or territo ries 
for the purpose of Article 29 
Member States shall only  include a confined establishment located in a third country or 
territory on the list of confined establishments provided for in Article 29, if the confined 
establishment is approved by the compete nt authority of the third country or territory and 
complies with the following conditions:  
(a) it must have an approval number assigned by the competent authority of the third 
country or territory;   
EN 36  EN (b) it must be clearly demarcated and the acces of animal s and humans to animal 
facilities must be controlled;  
(c) it must have adequate means for catching, confining and isolating animals, and have 
available and adequate quarantine facilities and approved standard operating 
procedures for new incom ing animals;  
(d) the animal accommodation areas must  be of a suitable standard and constructed in 
such a way that: 
(i) contact with animals outside the confined establishment is prevented and 
inspection s and any necessary  treatment can be easily carried out;  
(ii) the floors , walls and all other material or equipment can be cleaned and 
disinfected  easily;  
(e) as regards disease surveillance and control measures:  
(i) it must implement an appropriate disease surveillance plan which must include 
control measures against zoonosis, and update it according to the number and 
species of the animals  present in the confined establishment and to the 
epidemiological situation in and around the confined establishment as regards 
listed diseases and emerging diseases;  
(ii) it must subje ct to clinical, laboratory or post -mortem testing ungulates 
suspected of being infected or contaminated by agents of listed diseases or 
emerging disease;  
(iii) it must carry out , as appropriate , the vaccination and treatment of susceptible 
ungulates  against transmissible diseases;  
(f) it must keep, for a minimum period of three years, up -to-date records indicating:  
(i) the number and identity ( namely, the estimated age, sex, species and individual 
identification, where appropriate) of the ungulates  of each species present on 
the confined establishment ; 
(ii) the number and identity ( namely, the estimated age, sex, species and individual 
identification where appropriate) of ungulates arriving or leaving  the confined 
establishment , together with informa tion on the establishment of origin or 
destination  of such animals , the means of transport and the health status of 
those animals;  
(iii) details of the implementation and results of the disease surveillance and control 
plan provided for in point e(i); 
(iv) the results of clinical and laboratory tests and of post -mortem examinations 
provided for in point e(ii);  
(v) details of the vaccination and treatment provided for in point e(iii) ;  
(vi) instructions, if any, of the competent authority of the third count ry or territory 
of origin  as regards observations made during any  period of  isolation or 
quarantine.  
(g) it must ensure the disposal of the carcasses of ungulates which die of a disease or are 
euthanised; and  
(h) it must secure by contract or other legal instrument the services of an establishment 
veterinarian who shall be responsible for:   
EN 37  EN (i) the supervision of the activities of the establishment and compliance with the 
conditions for approval laid down in  of this Article ; 
(ii) the review of the disease surveillance plan  referred to in point e(i) at least 
annually.  
(i) by way of derogation of point (c) of Article 9, either have : 
(i) an arrangement with a laboratory approved by the competent authority  of the 
third country or territory to perform post -morte m examinations ; or 
(ii) one or more appropriate premises where post-mortem examinations may be 
performed under the authority of the approved veterinarian . 
Article 31 
Derogation from the requirement of listing of the confined establishment of origin of 
ungu lates   
1. By way of derogation from the requirement s laid down Article 3 and Article 
28(1)(a), consignments of ungulates  from establishments in third countries or 
territories  which do not comply with those requirements  shall be permitted to enter 
the Union if they are  intended for a confined establishment  and , provided that:  
(a) exceptional unforeseen circumstances render compliance with those 
requirements impossible;  
(b) those consignments comply with the conditions  laid down  in Article 3 2.  
2. The Member State of the place of destination of the consignment referred to in 
paragraph 1 shall notify the Commission and the Member States within the 
framework of the Standing Committee on Plants, Animals, Food and Feed and n otify 
directly the point  of arrival in the Union of the ungulates, of the authorisations 
granted pursuant to paragraph 1 and 2, prior to possible movement through other 
Member States and prior to the arrival of such ungulates into their territory.  
Article 32 
 Additional requirements to be fulfiled by establishments of origin of ungulates intended for a 
confined establishment pursuant to the derogation  laid down  in Article 31 
The competent authority of a Member State of destination shall only authorise derog ation s, as 
provided for in Article 31, for consignments of ungulates that comply with  the following 
additional conditions:  
(a) a prior application to the competent authority of the Member State of destination  for 
a specific  derogation as provided for in Article 3 1 was made by the owner, or a 
natural person representing that owner, and the Member State of destination granted 
that authorisation after having carried out a risk assessment that has indicated that the 
introduction  of such a consignment of ungulates would not present an animal health 
risk for the Union;  
(b) the ungulates have been quarantined in the third country or territory of origin under 
the supervision of the competent authority for the necessary period of time  required 
for them to  comply with  the specific animal health requirements laid down in 
Articles 33 and 34:  
EN 38  EN (i) at a place approved by the competent authority of the third country or territory 
of origin of the ungulates;  
(ii) in accordance with the arrange ments specified in the authorisation referred 
referred to in point (a) that must  provide at least the same guarantees as those 
provided for by  Article 2 8(2) to ( 4) and by Articles 3 3 and 3 4. 
(c) the ungulates must  be quarantined in the confined establishment of destination for a 
period of at least six months from the date of entry into the Union, during which 
period the actions provided for in Article 138 of Regulation (EU) 2017/625 and in 
particular in its point (a), (d) and (k) may be taken by the competent authorit y of the 
Member State of destination . 
Article 33 
Animal health requirements for the confined establishment of origin of ungulates  as regards 
listed diseases  
Consignments of u ngulates intended for a conf ined establishment located in the Union  shall 
only be permitted to enter the Union  if the confined establishment of origin complies with the 
following requirements  as regards listed diseases : 
(a) as regards the confined establishment of origin of the ungul ates, no case s or 
outbreak s of listed diseases referred to in the table set out in Part A of Annex 12 have 
been reported for the period s specified for those listed diseases in that table;  
(b) as regards the area in and around the confined establishment, no case s or outbreak s 
of listed diseases referred to in the table set out in Part B of Annex 12 have been 
reported for the period s specified for those listed diseases  in that table .  
Article 34 
Animal  health requirements for ungulates  of the consignment as  regards listed diseases  
Consignments of u ngulates intended for a confined establishment located in the Union  shall 
only be permitted to enter the Union  if the animals  of the consignment comply with the 
following additional animal health requirements:  
(a) they must  comply with a residency period in the confined establishment of origin for 
a continuous period of 6 months or since birth if they are less than 6 months of age;  
(b) they must  not have been in contact with animals of a lower health status during : 
(i) the period of 30 days prior to dispatch  to the Union , or since birth if the 
animals are less than 30 days of age ; 
(ii) their transport from the approved confined establishment of origin to the place 
of dispatch  to the Uni on;  
(c) as regarding the diseases referred to in the table set out in Part C of Annex 12 , they 
must either:  
(i) originate from a third country  or territory or zone thereof which complies with 
the disease  freedom periods for the relevant diseases  set out in that table ; or 
(ii) comply with the relevant specific guarantees set out in Part 12 of Annex 12 . 
(d) they must not have been vaccinated as referred to in the table set out in Part E of 
Annex 12;   
EN 39  EN (e) if they have been vaccinated against anthrax and rabies, informatio n on the date of 
vaccination, the vaccine used and the possible test performed to show a protective 
immune response, must have been provided b y the competent authority of the third 
country or territory of origin;  
(f) they must have been treated against in ternal and external parasites at least twice 
during the period of  40 days prior to date of dispatch to the Union.  
Where the specific guarantees referred to in point (c)(ii)  include a quarantine period in a 
vector protected -facility, this facility must comp ly with the requirements set out in Part F of 
Annex 12 . 
Article 35 
Movement and handling of ungulates intended to confined establishments after the entry  
Following their entry into the Union,  consignments of ungulates originating in a third country 
or territory, as referred to in Article 2 7, must  remain in the confined establishment of 
destination for a period of at least 6 months prior to the date of movement to  another confined 
establishment  in the Union, unless they are exported from the Union or moved for slaughter.   
EN 40  EN TITLE  3 
ANIMAL  HEALTH  REQUIREMENTS  FOR  POULTRY  AND  
CAPTIVE  BIRDS   
Chapter 1  
Specific animal health requirements for p oultry  
SECTION  1  
ANIMAL  HEALTH  REQUIREMENTS  FOR  ALL  SPECIES  AND  
CATEGORIES  OF POULTRY   
Article 36  
Poultry imported  into the third country  or territory of origin or zone  thereof  prior to  entry 
into Union  
1. The following consignments shall only be permitted to enter the Union  where the 
competent authority of the third country or territory of origin has p rovided  
guarantees in accordance with paragraph 2  for: 
(a) poultry imported into the third country or territory of origin or zone  thereof 
from anoth er third country or territory or zone thereof;  
(b) day-old chicks  from  parent flocks that were imported into the third country or 
territory of origin or zone thereof from another third country or territory or 
zone thereof.  
2. The competent authority  at the  border inspection post as referred to in paragraph I 
shall verify that the competent authority of the third country or territory of origin of 
the poultry  has provided guarantees that:  
(a) those poultry and parent flocks referred to in that paragraph were imported 
from a third country or territory or zone thereof, which is listed for the entry 
into Union of  such consignments ; 
(b) the import of the poultry and parent flocks referred to paragraph 1 into that 
third country or territory or zone thereof took place i n accordance with animal 
health requirements that are at least as stringent  as those applicable to 
consignments of those animals entering directly into the Union.  
Article 37 
Requirements concerning t he third country or territory of origin of poultry  or zon e thereof  
Consignments of p oultry shall only be permitted to enter the Union if they originate from a 
third country or territory or zone thereof  which complies with the following requirements :  
(a) it has a disease surveillance programme  for highly pathogenic avian influenza in 
place for a period of at least six months prior to the date of dispatch of the 
consignment to the Union and that surveillance programme complies with the 
requirements  laid down in either : 
(i) Annex 2  to this Regulation ;  
or  
EN 41  EN (ii) relevant  Chapter of the Terrestrial Animal Health Code of the World Animal 
Health Organisation ( OIE); 
(b) it is considered to be free from highly pathogenic avian influenza in accordance with 
Article 38;  
(c) where it carries out vaccination against highly pathogenic avian influenza , the 
competent authority of the third country or territory of origin has provided 
guarantees that:  
(i) the vaccination programme complies with the requirements set out in Annex 
13; 
(ii) the surveillance programme  referred to in point (a)  of this Article , in addition 
to the requirements set out in Annex 2 , complies with  the requirements set out 
in Part 2 of Annex 13 ; 
(iii) it has undertaken  to inform the Commission of any change to the vaccination 
programme  in the third country or territory or zone thereof ; 
(d) which:  
(i) in the case of poultry other than ratites, it is considered free from infection with 
Newcastle disease virus in accordance with Article 39;  
(ii) in the case of ratites:  
– it is considered free from infection with Newcastle disease virus in accordance 
with Article 39;  
or  
– it is not considered free from infection with Newcastle disease virus  in 
accordance with Article 39, but the competent authority of the third country or 
territory of origin has provided  guarantees  regarding  compliance with the 
requirements for infection with Newcastle disease virus  in relation to isolation, 
surveillance and testing, as set out in Annex 14 ; 
(e) where vaccination against infection with Newcastle disease virus is carried out , the 
competent authorit y of the third country or territory ha s provided guarantees that: 
(i) the vaccines used comply with the general and the specific criteria for vaccines 
against infection with Newcastle disease virus set out in Part 1 of Anne x 15; or 
(ii) the vaccines used comply with the general criteria for vaccines against 
infection with Newcastle disease virus set out in Part 1 of Annex 15 and the 
poultry meet the animal health requirements for poultry and hatching eggs 
originating from a third country or territory or zone thereof where vaccines 
used against infection with Newcastle disease virus do not meet the specific 
criteria set out in Part 1  of Annex 15, set out in Part 2 of Annex 15 ; 
(f) it has undertaken  that following  any outbreak  of highly pathogenic avian influenza or 
an outbreak  of infection with Newcastle disease virus , to submit the following 
information to the Commission:  
(i) information on the disease situation within 24 hours of confirmation of any 
initial outbreak of highly  pathogenic avian influenza  or infection with 
Newcastle disease virus ; 
(ii) regular updates on the disease situation;    
EN 42  EN (g) which has undertaken  to submit v irus isolates from initial outbreaks of highly 
pathogenic avian influenza and infection with Newcastle disease virus to the 
European Union Reference Laboratory for Avian Influenza and  Newcastle disease . 
Article 3 8 
Freedom from highly pathogenic avian influenza of the third country or territory of origin or 
zone thereof  
1. A third co untry or territory or zone thereof shall be considered as being free from 
highly  pathogenic avian influenza  when it has provided the following guarantees  to 
the Commission : 
(a) a surveillance program me for highly pathogenic avian influenza , in accordance 
with Article 37(a)  has been carried out during a period of at least 6 months 
preceding the date of certification of the consignment  by the official 
veterinarian for dispatch to the Union ;  
(b) highly pathogenic avian influenza has not  been present in the t hird country or 
territory or zone thereof for a period of at least 12 months preceding the date of 
certification of the consignment by the official veterinarian  for dispatch to the 
Union . 
2. Following an outbreak of highly pathogenic avian influenza in a third country or 
territory or zone thereof previously considered as free of that disease, as referred to 
in paragraph 1, that third country or territory or zone thereof shall again be 
consider ed as free of highly pathogenic avian influenza, subject to compliance with 
the following conditions:  
(a) a stamping out policy has been implemented to control highly pathogenic avian 
influe nza; 
(b) adequate cleaning and disinfection has been carried out o n all previously 
infected establishments;  
(c) during a period of at least three months following the completion of the 
stamping out policy and cleaning and disinfection referred to in points (a) and 
(b), the competent authority of the third country or terr itory has carried out a 
surveillance programme, providing at least the confidence by a randomised 
representative sample of the populations at risk to demonstrate the absence of 
infection taking into account the specific epidemiological circumstances in 
relation to the occurred outbreak(s), with negative results.   
Article 39 
Freedom from infection with Newcastle disease virus of the third country or territory of origin 
or zone thereof  
1. A third country or territory or zone thereof shall be considered free f rom infection 
with Newcastle disease virus  when no outbreak of infection with Newcastle disease 
virus has occurred in poultry in that third country or territory or zone thereof for a 
period of at least 12 months preceding the date of certification of the c onsignment by 
the official veterinarian for dispatch to the Union;   
2. When an outbreak of infection with Newcastle disease virus occurs in a third country 
or territory or zone thereof previously free from that disease, as referred to in  
EN 43  EN paragraph 1, that third country or territory or zone thereof shall again be considered 
as free from that disease  subject to compliance with the following conditions : 
(a) a stamping out policy has been implemented to control the disease;  
(b) adequate cleaning and disinfectio n has been carried out on all previously 
infected establishments;  
(c) during a period of at least three months following the completion of the 
stamping out policy and cleaning and disinfection referred to in points (a) and 
(b), the competent authority of t he third country or territory has demonstrated 
the absence of that disease in the third country or territory or zone thereof by 
intensified investigations including laboratory testing in relation to the 
outbreak.  
Article 40 
The establishment of origin of p oultry  
1. Consignments of b reeding poultry and productive poultry shall only be permitted to 
enter into the Union if they come  from establishments approved by the competent 
authority of the third country or territory of origin in accordance with requiremen ts 
which are at least as stringent as to those laid down in Article 8 of Regulation (EU) 
2019/… [ reference to DA on registration of establishments and identification of 
animals ], and: 
(a) the approval of which has not been suspended or withdrawn;  
(b) within a 10 km radius of which, including, where appropriate, the territory of a 
neighbouring country, there has been no outbreak  of highly pathogenic avian 
influenza or infection with Newcastle disease virus during the period of at least 
30 days  prior to the date of loading  for dispatch to the Union ; 
(c) in which no confirmed case of infection  with low pathogenic avian influenza 
viruses has  been reported  during the period of at least 21 days prior to the date 
of loading for dispatch to the Union . 
2. Consig nments of p oultry intended for slaughter shall only be permitted to enter into 
the Union if they  come from establishments : 
(a) within a 10 km radius of which, including, where appropriate, the territory of a 
neighbouring country, there has been no outbreak  of highly pathogenic avian 
influenza or infection with Newcastle disease virus during the  period of at least 
30 days  prior to the date of loading for dispatch  to the Union ; 
(b) in which no confirmed case of infection with low pathogenic avian influenza 
viruses has been reported during the period of at least 21 days prior to  the date 
of loading for dispatch to the Union . 
3. Consignments of day-old chicks  shall only be permitted to enter into the Union if 
they: 
(a) have been hatched in establishments appro ved by the competent authority of 
the third country or territory of origin in accordance with requirements which 
are at least as stringent as to those laid down in Article 7 of Regulation (EU) 
2019/… as regards rules for establishments keeping terrestrial animals and 
hatcheries, and the traceability of certain kept terrestrial animals and hatching 
eggs [document SANTE 7016/2018 ]; and  
EN 44  EN (i) the approval of which has not been suspended or withdrawn;  
(ii) within a 10 km radius of which, including, where appropriate, the 
territory of a neighbouring country, there has been no outbreak of highly 
pathogenic avian influenza or infection with Newcastle disease virus 
during the  period of at least 30 days  prior to the date of dispatch to the 
Union ; 
(b) come from flocks which have been kept in establishments approved  by the 
competent authority of the third country or territory of origin  in accordance 
with requirements which are at least as stringent as to those laid down in 
Article 8 of Regulation (EU) 2019/…  as regards rules for establishments 
keeping terrestrial animals and hatcheries, and the traceability of certain kept 
terrestrial animals and hatching eggs  [document SANTE 7016/2018 ], and  
(i) the approval had not been suspended or withdrawn at the time the 
hatching eggs , from which the day -old chick were hatched, were sent to 
the hatchery ;  
(ii) in which no confirmed case of infection with low pathogenic avian 
influenza viruses has been reported during the period of at least 21 days 
prior to the time of collection of the hatching eggs from which the day -
old chicks were hatched.  
Article 41  
Specific preventive measures for the containers in which poultry are transported  
Consignments of poultry shall only be p ermitted to enter into the Union if they  have been 
transported in containers which, in addition to the requirements of Article 18 , comply with the 
following requirements:  
(a) they are closed in accordance with the instructions of the competent authority of the 
third country or territory of origin in order to avoid any possibility of substitution of 
the content s; 
(b) they bear the information for the particular species and categ ory of poultry set out in 
Annex 16 ; 
(c) in the case of day -old chicks, they are disposable, clean and used for the first time.  
Article 42 
Entry of poultry into Member States with  status  free from  infection with Newcastle disease 
virus  without vaccination  
1. Consignments of breeding poultry and productive poultry intended for a Member 
State with status -free from  infection with Newcastle disease virus  without 
vaccination  shall only be permitted to enter into the Union if they comply with the 
following require ments : 
(a) they not be en vaccinated against infection with Newcastle disease virus;  
(b) they have been kept in isolation during a period of at least 14 days prior to the 
date of loading of the consignment for dispatch to the Union in the 
establishment of origin or quarantine establishment under the supervision of an 
official veterinarian , where:   
EN 45  EN (i) no poultry has been vaccinated against infection with Newcastle disease 
virus during a period of at least 21 days prior to the date of loading of the 
consignme nt; 
(ii) no bird which does not form part of the consignment ha s entered into the 
establishment during period referred to in point (i) ;  
(iii) no vaccination has been carried out . 
(c) they have tested negative, during the period of at least 14 days prior to the date 
of loading for dispatch to the Union , to serological tests to detect antibodies 
against Newcastle disease virus, performed  on blood samples at a level which 
gives 95% confidence of detecting infection at 5 % prevalence . 
2. Consignm ents of poultry intended for slaughter intended for a Member State with 
status -free from  infection with Newcastle disease virus  without vaccination , shall 
only be permitted to enter into the Union if they come from flocks which:  
(a) have not been vaccinated against infection with Newcastle disease virus and 
have tested negative, during a period of at least 14 days prior to  loading of the 
consignment for dispatch to the Union , to serological tests to detect antibodies 
against Newcastle  disease virus performed  on blood samples at a level which 
gives 95% confidence of detecting infection at 5% prevalence; or  
(b) have been vaccinated against infection with Newcastle disease virus but not 
with a live vaccine during the period of at least 30 days prior to the date of 
loading of the consignment for dispatch  to the Union  and underwent a virus 
isolation test for infection with Newcastle disease virus in the 14 days prior to 
that date on a random sample of cloacal swabs or faeces samples  taken  from at 
least 60 birds and tested negative.  
3. Consignments of day-old chicks intended for a Member State with status -free from  
infection with Newcastle disease virus  without vaccination  shall only be permitted to 
enter into the Union if they :  
(a) have not been vaccinated against infection with Newcastle disease virus;  
(b) come from hatching eggs coming from flocks which  comply with one of the 
following :  
(i) they have not been vaccinated against infection with Newcastle disease 
virus; or  
(ii) they have bee n vaccinated against infection with Newcastle disease virus 
using an inactivated vaccine; or  
(iii) they have been vaccinated against infection with Newcastle disease virus 
using a live vaccine at the latest 60 days prior to the date the eggs were 
collected . 
(c) come from a hatchery where working practices ensure that the eggs of day -old 
chicks intended for entry into the Union are incubated at completely separate 
times and locations from eggs not satisfying the requirements laid down in 
point ( b).  
EN 46  EN SECTION  2  
SPECIFIC  ANIMAL  HEALTH  REQUIREMENTS  FOR  BREEDING  AND  
PRODUCTIVE  POULTRY   
Article 43  
Identification of breeding ratites and production ratites  
Consignments of breeding ratites and production ratites shall only be permitted to enter into 
the Union if the y are individually identified by neck -tags or microchips : 
(a) with the code of the third country or territory of origin conforming with ISO 
Standard 3166 in the format of two -letter;  
(b) which  comply with ISO standards  11784 and 11785 .  
Article 44 
Specific animal health requirements for the flock of origin of consignments of breeding and 
productive poultry  
Consignments of breeding  poultry and productive poultry  shall only be permitted to enter into 
the Union if they  originate from flocks which compl y with the following requirements:  
(a) the flocks have not been vaccinated against  highly pathogenic avian influenza ; 
(b) where the flocks have been vaccinated against infection with Newcastle disease 
virus:  
(i) guarantees have been provided by the compete nt authorities of the third 
country or territory of origin that the vaccines used comply either with : 
– the general and the specific criteria for vaccines against infection with 
Newcastle disease virus set out in Part 1 of Annex 15 ; 
or 
– the general criteria for vaccines against infection with Newcastle disease 
virus set out in Part 1 of Annex 15 , and the poultry meet the animal 
health requirements for poultry and hatching eggs originating from a 
third country or territory or zone thereof where vaccines used against 
infection with Newcastle disease virus do not meet the specific criteria 
set out in Part 1  of Annex 15, set out in Part 2 of Annex 15 ; 
(ii) the information set out in Part 4 of Annex 15 must  be provided for the 
consignment;   
(c) the flocks have undergone a disease surveillance programme that meets the 
requirements set out in Annex II of Regulation (EU) 2019/… [ reference to DA on 
registration of establishments and identification of animals ], and were found not to 
be infected or sh owed any ground for suspecting any infection by the following 
agents : 
(i) Salmonella  Pullorum, Salmonella  Gallinarum and Mycoplasma  gallisepticum 
in case of Gallus gallus ; 
(ii) Salmonella  arizonae (serogroup O:18(k)), Salmonela Pullorum, Salmonella  
Gallina rum, Mycoplasma  meleagridis and Mycoplasma  gallisepticum in case of 
Meleagris gallopavo ; and   
EN 47  EN (iii) Salmonella  Pullorum and Salmonella  Gallinarum in case of Numida meleagris, 
Coturnix coturnix, Phasianus colchicus, Perdix perdix, Anas spp.  
SECTION  3  
SPECIF IC ANIMAL  HEALTH  REQUIREMENTS  FOR  POULTRY  
INTENDED  FOR  SLAUGHTER  
Article 45 
Specific animal health requirements for the flock of origin of consignments of poultry 
intended for slaughter  
Consignments of poultry  intended for slaughter shall only be permitted to enter into the Union 
if they originate from flocks which comply with the following requirements:  
(a) they have not been vaccinated against highly pathogenic avian influenza ;  
(b) if they have been vaccinated against infection  with Newcastle disease virus:  
(i) guarantees have been provided by the competent authority of the third country 
or territory of origin that: 
– the vaccines used comply with the general and the specific criteria for 
vaccines against infection with Newcastle dise ase virus set out in Part 1 
of Annex 15 ;  
or 
– the vaccines used comply with the general criteria for vaccines against 
infection with Newcastle disease virus set out in Part 1 of Annex 15  and 
the poultry meet the animal health requirements for poultry and ha tching 
eggs originating from a third country or territory or zone thereof where 
vaccines used against infection with Newcastle disease virus do not meet 
the specific criteria set out in Part 1  of Annex 15, set out in Part 2 of 
Annex 15; 
(ii) the informatio n set out in Part 4 of Annex 15  must  be provided for each 
consignment.  
SECTION  4  
SPECIFIC  ANIMAL  HEALTH  REQUIREMENTS  FOR  DAY -OLD  
CHICKS  
Article 46 
Specific animal health requirements for the flocks of origin of consignments of  day-old chicks  
Consignments of day-old chicks shall only be permitted to enter into the Union if they 
originate  from flocks which comply with the following requirements:  
(a) if the flocks have been vaccinated against highly pathogenic avian influenza , 
guarantees for compl iance with the minimum requirements for vaccination 
programmes and additional surveillance set out in Annex 13 , have been provided by 
the third country or territory of origin;   
(b) if the flocks have been vaccinated against infection with Newcastle disease  virus :  
(i) guarantees have been provided by the competent authority of the third country 
or territory of origin that the vaccines used comply either with :  
EN 48  EN – the general and the specific criteria for vaccines against infection with 
Newcastle disease virus set out in Part 1 of Annex 15 ; or 
– the general criteria for recognised vaccines against infection with 
Newcastle disease virus set out in Part 1 of Annex 15 and the poultry  and 
hatching eggs from which  the day -old chicks originated  meet the animal 
health requirements for poultry and hatching eggs originating from a 
third country or territory or zone thereof where vaccines used against 
infection with Newcastle disease virus do not meet the specific crite ria 
set out in Part 1  of Annex 15, set out in Part 2 of Annex 15 ; 
(ii) the information set out in Part 4 of Annex 15 must  be provided for each 
consignment;  
(c) the flocks have undergone a disease surveillance programme that meets the 
requirements set out in Annex II of Regulation (EU) 2019/… [ reference to DA on 
registration of establishments and identification of animals ] and were found not to be 
infected or showed any grounds for suspecting any infection by the following agents:  
(i) Salmonella  Pullorum,  Salmonella  Gallinarum  and Mycoplasma  gallisepticum  
in case of Gallus gallus ; 
(ii) Salmonella  arizonae  (serogroup O:18(k)), Salmonella  Pullorum , Salmonella  
Gallinarum, Mycoplasma  meleagridis and Mycoplasma  gallisepticum  in case 
of Meleagris gallopavo ; 
(iii) Salmonella  Pullorum and Salmonella  Gallinarum  in case of Numida meleagris, 
Coturnix coturnix, Phasianus colchicus, Perdix perdix, Anas spp.  
Article 47 
Specific animal health requirements for the hatching eggs of origin of consignments of day-
old chicks  
Consignments of day-old chicks shall only be permitted to enter into the Union if they  
originate from hatching eggs which:  
(a) comply with the animal health requirements for entry into the Union laid down in 
Title 2 of Part III ; 
(b) prior to being dispatched to the  hatchery, the hatching eggs had been marked in 
accordance with the instruction of the competent authority;  
(c) had been disinfected  in accordance with the instructions of the competent authority;  
(d) have had no contact with poultry or hatching eggs of a lower he alth status, captive 
birds or wild birds, either during transport to the hatchery  or in the hatchery . 
Article 48 
Specific animal health requirements for the day -old chicks  
Consignments of day-old chicks shall only be permitted to enter into the Union if th ey have 
not been vaccinated against avian influenza.   
EN 49  EN SECTION  5  
SPECIFIC  ANIMAL  HEALTH  REQUIREMENTS  FOR  LESS  THAN  20 
HEADS  OF POULTRY  
Article 49 
Derogation and specific requirements for consignments of less than 20 heads of poultry , other 
than ratites  
By d erogation from Article 14(3) , Articles 17, 18, 40 and 41 and Articles 43 to 48, 
consignments containing  less than 20 heads of poultry other than ratites , shall be permitted to 
enter the Union  provided that they comply with the following requirements:  
(a) the poultry  come from establishments  where : 
(i) no confirmed case of infection with  low pathogenic avian influenza viruses has 
been reported  during  the period of at least  21 days prior to date of loading of 
the consignment for dispatch to the Union or the date of collection of the 
hatching eggs from which the day -old chicks were hatched;  
(ii) within a 10 km radius of the establishment , including, where appropriate, the 
territory of a neighbouring country, there has been no outbreak  of highly 
pathogenic avian influenza or infection with Newcastle disease virus for a 
period of at least 30 days  prior to date of loading of the consignment for 
dispatch  to the Union ; 
(b) the poultry or , in the case of day -old chicks, the flock of origin  of the day -old chicks , 
have been isolated on the establishment of origin for a period of at least 21 days  prior 
to date of loading of the consignment for dispatch to the Union ; 
(c) as regards vaccination against highly pathogenic avian influenza : 
(i) the poultry not been vaccinated against highly pathogenic avian influenza ; 
(ii) where the parent flocks of the day -old chicks  have been vaccinated against 
highly pathogenic avian influenza , guarantees  for compliance with the 
minimum requirements for vaccination progra mmes and additional 
surveillance set out in Annex 13  have been provided by the third country or 
territory of origin;  
(d) where the poultry or the parent flock of the day -old chicks have been vaccinated 
against infection with Newcastle disease virus:  
(i) guara ntees have been provided by the competent authority of the third country 
or territory of origin that the vaccines used comply either with: 
– the general and the specific criteria for vaccines against infection with 
Newcastle disease virus set out in Part 1 o f Annex 15 ; or 
– the general criteria for vaccines against infection with Newcastle disease 
virus set out in Part 1 of Annex 15  and the poultry meet the animal health 
requirements for poultry and hatching eggs originating from a third 
country or territory or  zone thereof where vaccines used against infection 
with Newcastle disease virus do not meet the specific criteria set out in 
Part 1  of Annex 15,  set out in Part 2 of Annex 15 ; 
(ii) the information set out in Part 4 of Annex 15 must be provided for each 
consignment;   
EN 50  EN (e) the poultry or, in the case of day -old chicks the flock of origin  of the day -old chicks , 
were found not to be infected of showed any grounds for suspecting any infection by 
the following agents in tests performed in accordance with the requir ements for 
testing of consignments of less than 20 heads of poultry other than ratites and less 
than 20 hatching eggs thereof before the entry into the union , set out in Annex 17 ; 
(i) Salmonella  Pullorum, Salmonella  Gallinarum and Mycoplasma  gallisepticum 
in case of Gallus gallus ; 
(ii) Salmonella  arizonae (serogroup O:18(k)), Salmonela Pullorum, Salmonella  
Gallinarum, Mycoplasma  meleagridis and Mycoplasma  gallisepticum in case of 
Meleagris gallopavo ; and  
(iii) Salmonella  Pullorum and Salmonella  Gallinarum i n case of Numida meleagris, 
Coturnix coturnix, Phasianus colchicus, Perdix perdix, Anas spp.  
SECTION  6  
SPECIFIC  ANIMAL  HEALTH  REQUIREMENTS  FOR  MOVEMENT  
AND  HANDLING  OF POULTRY  AFTER  THE  ENTRY  INTO  THE  
UNION   
Article 50 
Obligation s on operators at the esta blishment of destination following the entry into the 
Union of consignments of poultry  
1. Operators at the establishment of destination shall keep breeding poultry, production 
poultry, except production poultry for restocking supplies of game birds, and da y-old 
chicks which have entered into the Union from a third country or territory or zone 
thereof on the establishments of destination from their date of arrival for a 
continuous period of at least:  
(a) 6 weeks;  
or  
(b) until the day of slaughter, when th e animals are slaughtered within 6 weeks of 
the date of arrival .  
2. In the case of poultry other than ratites, the 6 week period provided for in paragraph 
1(a), may be reduced to 3 weeks, provided that, at the request of the operator, 
sampling and testing  in accordance with Article 51(b) have been carried out with 
favourable results.  
3. Operators at the establishment of destination shall ensure that poultry referred to in 
paragraph 1 , undergo a clinical inspection carried out by an official veterinarian on 
the establishment of destination no later than the date of expiry of the relevant 
periods provided for in that paragraph .  
4. During the periods provided for in paragraph 1, operators  shall keep poultry which 
have entered into the Union from a third country or territory or zone thereof, separate 
from other flocks of poultry.   
5. Where poultry referred to in paragraph 1 are placed in the same flock  as other poultry 
present  at the establishment of destination , the periods referred to in paragraph 1 (a) 
and (b)  shall commence from the date of introduction of the last bird on the  
EN 51  EN establishment of destination and no poultry present shall be moved from the flock  
before the expiry  of those periods.  
Article 51 
Obligation on the competent authorit ies as regards s ampling and testing of consignments of 
poultry after entry into the Union  
The competent authority of the Member State of destination shall  ensure  that:  
(a) during the periods provided for in Article 50( 1), breeding poultry, production 
poultry, except production poultry for restocking supplies of game birds, and day-old 
chicks which have entered into the Union from a third country or territory or zone  
thereof , undergo a clinical inspection carried out by an official veterinarian on at the 
establishment of destination no later than the date of expiry of the relevant periods 
provided for in that Article and, where necessary, sample d for testing to monitor their 
health status;  
(b) in the case of poultry other than ratites and when it is requested by the operator as 
referred to in Article 50(2), sampling and testing of poultry other than ratites is 
carried out in accordance with Annex 18.  
Article 52 
Obligation on th e competent authorit ies as regards s ampling and testing following the entry 
into the Union of consignments of ratites originating from a third country or territory or zone  
thereof not free from infection with Newcastle disease virus  
The competent authority  of the Member State of destination shall ensure that  breeding ratites, 
production ratites and day -old chicks of ratites that have entered into the Union from a third 
country or territory or zone  thereof that is not free from infection with Newcastle  disea se 
virus, during the period s provided for in Article 50(1): 
(a) they are subject to a virus detection test for infection with Newcastle disease virus 
carried out by the competent authority on a cloacal swab or faeces sample from each 
ratite ; 
(b) in the cas e of consignments of ratites  destined for a Member States with status -free 
from  infection with Newcastle disease virus  without vaccination  from a third country 
or territory or zone  thereof not free from infection with Newcastle disease virus, in 
addition t o the requirements referred to in point (a) , they are subject to a serological 
test for infection with Newcastle disease virus carried out by the competent authority 
on each ratite ; 
(c) all ratites shall have tested negative to the tests provided for in points (a) and (b)  
prior to their release from isolation.   
EN 52  EN Chapter 2  
Specific animal health requirements for captive birds  
SECTION  1  
ANIMAL  HEALTH  REQUIREMENTS  FOR  CAPTIVE  BIRDS   
Article 53 
Requirements concerning the Identificatio n of captive birds  
Consignments of captive birds shall only be permitted to enter the Union if they  are identified 
with an individual identification number by means of a unique marked closed leg -ring or a 
microchip, which contains at least the following  information : 
(a) the code of the third country or territory of origin  conforming with ISO Standard 
3166 in the format of two -letter ; 
(b) a unique serial number.  
Article 54 
Specific preventive measures for the containers in which captive birds are transported  
Consignments of captive birds shall only be permitted to enter the Union if they are to  be 
transported in containers which, in addition to the requirements regarding  containers laid 
down in Article 18 , comply with the following requirements:  
(a) they are closed  in accordance with the instructions of the competent authority of the 
third country or territory of origin in order to avoid the possibility of any substitution 
of the content s; 
(b) they bear the information for the particular species and  category of birds set out in 
Annex 16;  
(c) they are used for the first time.  
Article 55 
Requirements concerning the establishment of origin of the consignment of captive birds  
Consignments of captive birds shall only be permitted to enter the Union if they come from an 
establishment which complies with the following requirements:  
(a) it has been approved by the competent authority of the third country or territory of 
origin as meeting the specific animal requirements  laid down in Article 56, and that 
approval has not been suspended or withdrawn ; 
(b) it has been assigned a unique approval number by the competent authority of the 
third country or territory of origin, which has been communicated to the 
Commissio n; 
(c) the name and approval number of the establishment of origin appears on a list of 
establishments drawn up and published by the Commission;   
(d) within a 10 km radius of  the establishment , including, where appropriate, the 
territory of a ny neighbourin g country, there has been no outbreak of highly 
pathogenic avian influenza or infection with Newcastle disease virus for a period of 
at least the preceding 30 days  prior to the date of loading for dispatch to the Union ;  
EN 53  EN (e) in the case of psittacidae, either:  
(i) avian chlamydiosis has been diagnosed on the establishmen t for a period of at 
least the 60 days prior to the date of loading for dispatch to the Union and in 
case avian chlamydiosis has been confirmed on the establishment during the 
last 6 mont hs prior to the date of loading for dispatch to the Union, the 
following measures have been applied:  
– infected birds and birds likely to be infected have received treatment;  
– following  the completion of the treatment, they have been found negative 
to laborat ory testing for avian chlamydiosis;  
– after the completion of the treatment, the establishment  has been cleaned 
and disinfected;   
– at least 60 days have elapsed from the completion of the cleaning and 
disinfection referred to  in point (iii) ;  
or 
(ii) the anim als have been kept under veterinary supervision for the 45 days prior 
to the date of loading for dispatch to the Union and were treated against avian 
chlamydiosis.  
Article 56 
Specific animal health requirements for the approval, maintenance of approval an d 
suspension , withdraw al or regranting  of the approval of the establishments of origin of the 
consignment of captive birds  
1. Consignments of captive birds shall only be permitted to enter into the Union if  they 
come from establishments approved by the competent authority of the third country 
or territory of origin as referred to in Article 5 5, and that comply with the following 
requirements set out in  Annex 19 : 
(a) point 1, in relation to biosecurity measures;  
(b) point  2, in relation to facilities and equipment;  
(c) point 3 , in relation to record keeping;  
(d) point 4, in relation to personnel;  
(e) point 5, in relation to health  status.  
2. Consignments of captive birds shall only be permitted to enter into the Union if they 
come fr om establishments which  are under the control of an official veterinarian of 
the competent authority  of the third country or territory , who shall:  
(a) ensure that the conditions set out in this Article  are met;  
(b) visit the premises of the establishment at leas t once per year;  
(c) audit the activity of the veterinarian of the establishment and the 
implementation of the annual disease surveillance plan;  
(d) verify that the results of the clinical, post -mortem and laboratory tests on the 
animals have revealed no occurrence of highly pathogenic avian influenza, 
infection with Newcastle disease virus or avian chlamydiosis .   
EN 54  EN 3. The approval of an establishment of captive birds shall be suspended or withdrawn 
where that establishment no longer com plies with the conditions set out in 
paragraphs 1 and 2, or there has been a change of use so that it is no longer used 
exclusively for c aptive birds.  
4. The approval of an establishment of captive birds shall be suspended when the 
competent authority of the third country or territory  has received notification of the 
suspicion of highly pathogenic avian influenza , infection with Newcastle d isease 
virus or avian chlamydiosis , and until the suspicion has been officially ruled out. 
Following the notifica tion of suspicion, the necessary measures to confirm or rule out 
the suspicion and to avoid any spread of disease are taken, in accordance with  the 
requirements of [ C(2019)4057, (EU) 2019/… of … supplementing Regulation (EU) 
2016/429 of the European Parliament and  the Council, as regards rules for the 
prevention and control of certain transmissible animal listed diseases ] shall be 
implemented . 
5. When the approval of an establishment has been suspended or withdrawn, the 
establishment shall again be approved provided the following conditions are met :  
(a) the disease and the source of infection has been eradicated ;  
(b) adequate  cleaning and disinfection has been carried out on previously infected  
establishment s;  
(c) the establishment fulfil s the conditions laid down in paragraph  1. 
6. Consignments of captive birds shall only be permitted to enter into the Union when 
the third country or territory of origin h as undertaken to  inform the Commission of 
the suspension, withdrawal or re -granting of approval of any establishment . 
Article 57 
Specific animal health requirements for the captive birds  
Consignments of captive birds shall only be permitted to enter the Un ion if they : 
(a) have not been vaccinated against highly pathogenic avian influenza;  
(b) have been vaccinated against infection with Newcastle disease virus and the 
competent authority of the third country or territory of origin has provided 
guarantees that the vaccines used comply with the general and specific criteria for 
vaccines against infection with Newcastle disease virus set out in Part 1 of Annex 15;  
(c) have been subjected to a virus detection test  for highly pathogenic avian influenza 
and Newcast le disease with negative results, within a period of 7 to 14 days prior to 
the date of loading for dispatch to the Union . 
Article 58 
Requirements concerning the entry of consignments of captive birds  into Member States with 
status  free from  infection with Newcastle disease virus  without vaccination  
Consignments of captive birds  of galliformes  species intended for a Member State with status  
free from  infection with Newcastle disease virus  without vaccination , shall only be permitted 
to enter the Union if the animals of the consignment : 
(a) have not be vaccinated against infection with Newcastle disease virus;   
EN 55  EN (b) have been kept in isolation for a period of at least 14 days prior to the date of loading 
of the consignment for dispatch  to the Uni on in the establishment of origin or 
quarantine establishment in the third country or territory of origin  under the 
supervision of an official veterinarian , where:  
(i) no bird has been vaccinated against infection with Newcastle disease virus 
during the period of 21 days preceding the date of dispatch of the consignment ; 
(ii) no bird which was not intended for the consignment ha s entered into the 
establishment during that time;  
(iii) no vaccination has been carried out  on the establishment ; 
(c) have tested negative, during the period of 14 days prior to the date of loading for 
dispatch to the Union , to serological tests to detect the presence of antibodies against 
Newcastle disease virus, performed  on blood samples at a level which gives  95 % 
confidence of  detecting infection at 5 % prevalence . 
SECTION  2  
SPECIFIC  ANIMAL  HEALTH  REQUIREMENTS  FOR  MOVEMENT  
AND  HANDLING  OF CAPTIVE  BIRDS  AFTER  THE IR ENTRY  INTO  
THE  UNION  
Article 59 
Requirements concerning the movement of captive birds after entry  into th e Union  
Following their entry into the Union, consignments of captive birds shall be transported 
without delay directly to a quarantine establishment  approved in accordance with Article 14 
of Regulation (EU 2019/…  as regards animal health requirements for  movements within the 
Union of terrestrial animals and hatching eggs  [document C(2019)4058 ], as follows:  
(a) the total journey from the point of entry into the Union to the quarantine 
establishment  must not exceed nine hours;  
(b) vehicles used for the transport of the consignment to the quarantine establishment  
must be sealed by the competent authority in such a way that prevents the possibility 
of any substitution of the content s. 
Article 60 
Obligation on operators at the quaranti ne establishment  following the entry into the Union of 
consignments of captive birds  
Operators of the quarantine establishment  for the captive birds referred to in Article 59 shall:  
(a) keep captive birds quarantined for a period of at least 30 days;  
(b) where sentinel birds are used for examination, sampling and testing procedures, 
ensure that:  
(i) a minimum number of 10 sentinel birds are used in each unit of the approved 
quarantine centre;  
(ii) they are at least three weeks old and used only once for t hose purposes;  
(iii) they are either leg-banded for identification purposes or identified with another 
non-removable means of identification;   
EN 56  EN (iv) they are unvaccinated and have been found sero -negative for highly pathogenic 
avian influenza and infection  with Newcastle disease virus within a period of 
14 days prior to the date of commencement of quarantine;  
(v) they are placed in the approved quarantine establishment  before the arrival of 
the captive  birds  in the common air  space and as close as possible to the 
captive birds so that close contact between the sentinel birds and the 
excrements of the captive birds in quarantine is ensured.  
Article 61 
Obligation on the  competent authorities following the entry into the Union of consignments of 
captive birds  
Following the arrival of the captive birds in the quarantine establishment  referred to in Article 
59, the competent authority shall:  
(a) inspect the conditions of quarantine, including an examination of the mortality 
records a nd a clinical inspection of the captive birds, at least at the beginning and the 
end of quarantine period;  
(b) subject the captive birds to testing for highly pathogenic  avian influenza and 
infection with Newcastle disease virus, in accordance with the examination, 
sampling and testing procedures  set out in Annex 20 .  
Article 62 
Release of the captive birds from quarantine  
The operator of the quarantine establishment  referred to in Article 59 shall only release the 
captive birds from quarantine on the written authorisation an official veterinarian.   
EN 57  EN TITLE  4 
ANIMAL  HEALTH  REQUIREMENTS  FOR  HONEYBEES  AND  
BUMBLE  BEES  
Chapter 1  
General animal health requirements for honeybees and bumble 
bees 
Article 63 
Authorised categories of bees  
Only consignments of the following categories of honey bees shall be permitted to enter the 
Union : 
(a) queen s of honeybees;  
(b) bumble bees . 
Article 64 
Dispatch to the Union of honeybees and bumble bees  
Consignments of queen s of honeybees and bumble bees  shall only be permitted to enter the 
Union if they  comply with the following requirements:  
(a) the packaging material and queen cages used to dispatch the honeybees and bumble 
bees into the Union must : 
(i) be new ;  
(ii) not have been in contact with any bees and brood combs ;  
(iii) have been subject to all precautions to prevent their contamination with 
pathogens causing diseases of honeybees  or bumble bees.  
(b) the feed products accompanying the honeybees and bumble bees  must be free from 
pathogens causi ng their diseases ; 
(c) the packaging material and accompanying products must have undergone a visual 
examination before dispatch to the Union to ensure that they do not pose an animal 
health risk and do not contain:  
(i) in the case of honeybees, small hiv e beetle and Tropilaelaps  mite in any of 
their life stages; and  
(ii) in the case of bumble bees , small hive beetle, in any of their life stages.  
Chapter 2  
Specific animal health requirements for honeybees  
Article 65 
The apiary of origin of honeybees  
Consig nments of queen bees of honeybees  shall only be permitted to enter the Union if they 
originate  from an apiary  which  is situated in an area :   
EN 58  EN (a) of at least a 100 km radius, including where appropriate the territory of a 
neighbouring third country : 
(i) where no case or outbreak of small hive beetle or of Tropilaelaps  mite has been 
reported;  
(ii) there are no restrictions in place due to a suspicion, case  or outbr eak of the 
diseases  referred to in (i) . 
(b) of at least 3 km radius, including where appropriate the terr itory of a neighbouring 
third country:   
(i) no case or outbreak of American foulbrood has been reported for a period of  at 
least 30 days prior to  the date of loading for dispatch  to the Union;   
(ii) there are no restrictions in place due to a suspicion, case  or outbreak  of 
American foulbrood disease during the period  referred to in point ( i);  
(iii) where there ha d been  a previous outbreak of American foulbrood  before the 
period referred to in point (i) , all hives were subsequently check ed by the 
competent authority in the third country or territory  of origin and all infected 
hives were treated and subsequently inspected with favourable results  within a 
period of 30 days from the date of last recorded case  of that disease . 
Article 66 
The hive of origin of honeybees  
Consignments of queen s of honeybees shall only be permitted to enter the Union if they 
originate  from hives from which samples of the comb have been tested  for American 
foulbrood with negative results  within the  period of 30 day s prior to the date of loading for 
dispatch to the Union . 
Article 67 
The consignment of honeybees  
Consignments  of queen s of honeybees shall only be permitted to enter the Union if they  are in 
closed cages, each containing one single queen bee with a maximu m of 20 accompanying 
attendants.  
Article 68 
Additional guarantees for honeybees destined to certain Member States or zone as regards 
the infestation with the varroa spp.  
Consignments of queen bees of honeybees destined to a Member State or zone with disease -
free status for varroa spp . shall only be permitted to enter the Union if the y comply  with the 
following requirements:  
(a) the animals must originate from a third country  or territory  or zone there of free of  
infestation with varroa spp .; 
(b) in the third country  or territory  of origin or zone  thereof , no case of infestation with 
varroa spp . has been  reported for a period of  30 days prior to the date of loading for 
dispatch to the Union ;  
(c) every precaution has been taken to avoid contamination of the consignment with 
infestation with varroa spp.  during loading and dispatch  to the Union .  
EN 59  EN Chapter 3  
Specific animal health requirements for bumble bees  
Article 69 
The establishment of origin of bumble bees  
Consignments of bumble bees  shall only be permitted to enter the Union if they : 
(a) have been bred and kept in an environmentally isolated bumblebee production 
establishment which:  
(i) has facilities which ensure that the production of bumble bee s is carried out 
inside of a flying insect -proof building;  
(ii) has facilities and equipment which ensure that the bumble bees  are further 
isolated in separate epidemiological units and each colony in closed containers 
within the building throughout the wh ole production;  
(iii) the storage and handling of pollen within the facilities is isolated from the 
bumble bees throughout the whole production of bumble bees until it is fed to 
them; 
(iii) has standard operating procedures to prevent the entry of small hive beetle into 
the establishment and to regularly survey for the presence of small hive beetle 
within the establishment ; 
(b) within the establishment  referred to in point (a) , the bumble bees  must  come from an 
epidemiological unit in which small hive bee tle has not been detected.  
Article 70 
The consignment of bumble bees  
Consignments of bumble bees shall only be permitted to enter the Union if they have been 
dispatched to the Union  in closed containers, each containing a colony of a maximum of 200 
adult bumble bees , with or without a queen.  
Chapter 4  
Specific animal health requirements for handling after the entry 
of honeybees and bumble bees  
Article 71 
Handling after the entry of honeybees and bumble bees  
1. Following their entry into the Union , queen s of honeybees must  not be introduced in 
local colonies unless they are transferred from the transport cage to new cages in 
accordance with paragraph 2  with the permission and, as appropriate, under the 
direct supervision of the competent authority.  
2. Followi ng the transfer in new cages as referred to in paragraph 1, the transport cages, 
attendants, and other material that accompanied the queen honeybees from the third 
country of origin must be  submitted to an official  laboratory for examination for the 
presen ce of the small hive beetle, including eggs and larvae, and any signs of the 
Tropilaelaps  mite.   
EN 60  EN 3. Operator s receiving  bumble bees  shall destroy th eir container and the packaging 
material that accompanied the m from the third country or territory of origin  but they 
may keep them in the container in which they entered into the Union until the end of 
the lifespan of the colony.  
Article 72 
Specific o bligations for the competent authorities  in the Member States  
The competent authority of the Member State of the  place of destination of the consignment 
of honeybees or bumble bees  referred to in Article 64  shall : 
(a) supervise the transfer from the transport cage to new cages referred Article 7 1(1); 
(b) ensure the submission by the operator of the materials referre d to in Article 7 1(2);  
(c) have arrangements in place which ensure that the official laboratory referred to in 
Article 7 1(2) destroys the cages, attendants and the material after the laboratory 
examination  provided for in that provision . 
TITLE  5 
ANIMAL  HEALTH  REQUIREMENTS  FOR  THE  ENTRY  INTO  
THE  UNION  OF DOGS,  CATS  AND  FERRETS   
Article 73 
Dispatch of the dogs, cats and ferrets to the Union  
Consignments of dogs, cats and ferrets shall only be permitted to enter the Union if they  have 
been dispatched  directly from their establishment of origin to the Union, or if they transited 
through a third country  or territory or zone thereof which is listed  for the entry of dogs, cats 
and ferrets into the Union.  
Article 74 
Identification of dogs, cats and ferrets  
1. Consignments of dogs, cats and ferrets shall only be permitted to enter the Union if 
they have been individually identified by means of an injectable transponder 
implanted by a veterinarian which fulfils the technical requirements for means of 
identifi cation of animals laid down in Regulation (EU) 2019/…  [reference to 
Implementing Regulation  on identification ]. 
2. Where the implanted injectable transponder referred to in paragraph 1 does not fulfil 
the technical specifications referred to in that paragraph, the operator responsible for 
the entry into the Union of the consignment shall provide the reading device which 
enab les the verification of the individual identification of the animal  at any time . 
Article 75  
The third country  or territory of origin  or zone thereof of dogs, cats and ferrets  
Consignments of dogs, cats and ferrets shall only be permitted to enter the Unio n if they 
originate from a third country  or territory or zone thereof  where rules on the prevention and 
control of rabies are in force and implemented effectively to minimise the risk of infection of 
dogs, cats and ferrets, including rules on imports of th ose species from other third countries or 
territories.   
EN 61  EN Article 76  
The dogs, cats and ferrets  
1. Consignments of dogs, cats and ferrets  shall only be permitted to enter the Union if 
they comply with the following requirements :  
(a) they have received a rab ies vaccination that complies with the following 
conditions:  
(i) the animals  must be  at least 12 weeks old at the time of vaccination;  
(ii) the vaccine must compl y with the requirements set out in Annex III to 
Regulation (EU) No 576/2013 of the European Parliament and of the 
Council ; 
(iii) at the day of dispatch to the Union, 21 days must have elapsed since the 
completion of the primary rabi es vaccination ; 
(iv) a certified copy of the vaccination details must be attached  to the animal 
health certificate r eferred to in Article 3 (1)(c)(i) . 
(b) they must have undergone a valid rabies antibody titration test, in accordance 
with point 1 of Annex 21.  
2. By way of derogation of paragraph 1 (b), dogs, cats and ferrets originating in third 
countries or territories o r zones thereof included in the list set out in Regulation (EU) 
No 577 /2013 shall be permitted to enter the Union without being subjected to the 
rabies titration test . 
3. Consignments of dogs shall be permitted to enter  into a Member State with disease -
free status for Echinococcus multilocularis  or an approved eradication program me 
for infestation with  that disease , if they have been treated against this infestation in 
accordance with  Part 2 of Annex 21 . 
Article 77 
Derogation for dogs, cats and ferrets intended for a confined or a quarantine establishment  
By way of derogation from Article 7 6, consignments of dogs, cats and ferrets which do not 
comply with the requirements regarding vaccination against rabies and requirements  
regarding  infestation with Echinococcus multilocularis  shall be permitted to enter the Union 
provided that they are intended for direct entry either to: 
(a) a confined establishment; or 
(b) an approved quarantine establishment in the Member State of destination.  
Article 78 
Moving and handling after the entry into the Union of dogs, cats and ferrets intended for a  
confined or a quarantine establishment  
1. Consignments of d ogs, cats and ferrets intended to a confined establishment in the 
Union shall be maintained  in the confin ed establishment of destination for a period of 
at least 60 days after the date of their entry into the Union.  
2. Consignments of d ogs, cats and ferrets intended for direct entry  to an approved 
quarantine establishment as referred to in Article 7 7(b) shall be maintained in that 
establishment  for a period of :  
EN 62  EN (a) not less than six months from the date of their arrival in the case of non -
compliance with the requirements for rabies vaccination  provided for in Article 
76(1); or 
(b) in the case of dogs  not complying  with the requirements for  infestation with 
Echinococcus multilocularis  provided for in Article 76(2), 24 hours following 
a treatment against infestation with Echinococcus multilocularis in accordance 
with point 2 of Annex 21 .  
Part III  
Animal hea lth requirements for the entry into the Union of 
germinal products  as referred to in Articles 3 and 5  
TITLE  1 
ANIMAL  HEALTH  REQUIREMENTS  FOR  GERMINAL  
PRODUCTS  OF UNGUL ATES  
Chapter 1  
General animal health requirements for germinal products of 
ungulates   
Article 79 
The third country or territory of origin or zone thereof  
Consignments of semen , oocytes and embryos of bovine, porcine, ovine, caprine and equine 
animals shall only be permitted to enter the Union if they were collected from animals which 
come  from thi rd countries or territories which comply with the animal health requirements 
laid down in Article 2 2. 
Article 8 0 
The residency period of donor animals  
Consignments of semen , oocytes and embryos of bovine, porcine, ovine, caprine and equine 
animals  shall only be permitted to enter the Union if they were collected from animals which:  
(a) remained for a period of at least 6 months prior to the date of collection in a third 
country or territory or zone thereof which is listed for the entry into the Uni on of the 
particular species and category of germinal product;   
(b) for a period of at least 30 days prior to the date of first collection of the germinal 
products and during the collection period:  
(i) were kept on establishments not situated in a restricted zone established due to 
the occurrence in bovine, porcine, ovine, caprine and equine animals of a 
category A disease or of an emerging disease relevant for the bovine, porcine, 
ovine, caprine or equine an imals ;  
(ii) were kept on a single establishment on which no category D diseases relevant 
for the bovine, porcine, ovine, caprine or equine animals  were reported;  
(iii) were not in contact with animals from establishments, situated in a restricted 
zone ref erred to in (i) or from establishments referred to in (ii);  
(iv) were not used for natural breeding.   
EN 63  EN Article 8 1 
Identification of donor animals  
Consignments of semen , oocytes and embryos of bovine, porcine, ovine, caprine and equine 
animals shall only be p ermitted to enter the Union if they were collected from animals which 
were identified in accordance with  Article 2 1. 
Article 8 2 
The germinal product establishments  
1. Consignments of semen, oocytes and embryos of bovine, porcine, ovine, caprine and 
equine animals shall only be permitted to enter the Union if they were dispatched 
from approved germinal products establishments which are listed by competent 
authorities of listed third cou ntries or territories  or zones thereof . 
2. Consignment s of germinal products shall only  be permitted to enter the Union from 
approved germinal product establishments referred to in paragraph 1 that comply 
with the following requirements set out in  Annex I to Regulation (EU) 2019/… as 
regards the approval of germinal product establishments and the traceability and 
animal health requirements for movements within the Union of germinal products of 
certain kept terrestrial animals [document C(2019)4055] : 
(a) Part 1 of that Annex, in respect of a semen collection center;   
(b) Part 2 of that Annex, in respect of an embryo collection team;  
(c) Part 3 of that Annex, in respect of an embryo production team;  
(d) Part 4 of that Annex, in respect of a germinal p roduct processing 
establishment;  
(e) Part 5 of that Annex, in respect of a germinal product storage center.  
Article 8 3 
The germinal products  
Consignments of semen, oocytes and embryos of animals of bovine, porcine, ovine, caprine 
and equine animals  shall o nly be permitted to enter the Union  if those germinal products  
comply with the following requirements : 
(a) they are marked in such a way that the following information can be readily 
established:  
(i) the date of collection or production of those germinal p roducts;  
(ii) the species and identification of the donor animal(s);  
(iii) the unique approval number, which shall include the ISO 3166 -1 aplha -2 code 
of the country in which the approval is granted ; 
(iv) any other relevant information;  
(b) they fulfil animal health requirements for the collection, production, processing and 
storage set out in Annex III to Delegated Regulation (EU) 2019/…  as regards the 
approval of germinal product establishments and the traceability and animal health 
requirements for mo vements within the Union of germinal products of certain kept 
terrestrial animals  [document C(2019)4055 ].  
EN 64  EN Article 8 4 
The transport of germinal products  
1. Consignments of semen, oocytes and embryos of animals of bovine, porcine, ovine, 
caprine and equine a nimals shall only be permitted to enter the Union if: 
(a) they were placed in a transport container  which  complies wi th the following 
requirements:  
(i) it was sealed and numbered prior to the dispatch from the approved 
germinal product establishment under  the responsibility of a centre or a 
team veterinarian, or by an official veterinarian;  
(ii) it was cleaned and either disinfected or sterilised before use, or is single -
use container;  
(iii) it was filled in with the cryogenic agent which was not previous ly used 
for other products.  
(b) only one type of germinal products of one species was placed in the transport 
container  referred to in point (a) . 
2. By the way of derogation from paragraph 1(b), operators may place in one transport 
container semen, oocytes  and embryos of the same species provided that:  
(a) straws or other packages in which germinal products are placed are securely 
and hermetically sealed;  
(b) the germinal products of different types are separated from each other by 
physical compartments or  by being placed in secondary protective bags.  
3. By way of derogation from paragraph  1(b), operators may place in one transport 
container semen, oocytes and embryos of ovine and caprine animals.   
Article 8 5 
Additional requirements for the transport of sem en 
Consignments of semen bovine, porcine, ovine and caprine animals which has been collected 
from more than one donor animal and placed in a single straw or another package  for the 
purposes of entry  into the Union  shall  only be permitted to enter the Union  if: 
(a) that semen was collected and dispatched from a single semen collection centre where 
it was collected;  
(b) there were procedures in place as regards processing of that semen in order to ensure  
that it complies with the marking requirements of point (a) of Article 8 3. 
Chapter 2  
Specific animal health requirements for germinal products of 
bovine animals  
Article 8 6 
The establishment of origin of donor bovine animals  
Consignments of semen , oocytes  and embryos of bovine animals if they were collected f rom 
animals shall only be permitted to enter the Union if they  come from establishments : 
(a) which comply with the requirements of Article 2 3;  
EN 65  EN (b) in the case of donor animal s of semen prior to their admission to a quarantine 
accommodation, which were free f rom the following diseases  and have never been 
kept previously in any establishment of a lower health status : 
(i) infection with Mycobacterium tuberculosis complex  (M. bovis , M. caprae  and 
M. tuberculosis ); 
(ii) infection with Brucella abortus , Brucella melitensis  and Brucella suis ; 
(iii) enzootic bovine leukosis;  
(iv) infectious bovine rhinotracheitis/ infectious pustular vulvovaginitis.  
Article 8 7 
Specific animal health requirements for donor bovine animals  
Consignments of semen, oocytes or embryos  shall only be permitted to  enter the Union  if they 
were collected  from donor bovine animals that comply with the animal health requirements 
laid down in Part 1 and Chapters I , II and  III of Part 5 of Annex II to Regulation (EU) 
2019/…  as regards the approval o f germinal product establishments and the traceability and 
animal health requirements for movements within the Union of germinal products of certain 
kept terrestrial animals  [document C(2019)4055 ]. 
Article 8 8 
Derogations from the requirements for the estab lishment of origin of donor bovine animals  
1. By the way of derogation from Article 8 6(b)(iii), consignments of semen of bovine 
animals shall be permitted to enter the Union if a donor animal comes from an 
establishment which is not free from enzootic bovine leukosis and : 
(a) is less younger than 2 years of age and which has been produced by a dam 
which has been subjected, with  negative results, to  a serological test for 
enzootic bovine leukosis after removal of the animal from the dam; or  
(b) has reach ed the age of 2 years and has been subjected, with a negative result, to 
a serological test for enzootic bovine leukosis.  
2. By the way of derogation from Article 8 6(b)(iii), consignments of oocytes and 
embryos of bovine animals shall be permitted to enter  the Union if a donor animal 
comes from an establishment which is not free from enzootic bovine leukosis and i s 
less than 2 years of age,  and provided that the official veterinarian responsible for the 
establishment of origin has certified that there has b een no clinical case of enzootic 
bovine leukosis during a period of at least the preceding 3 years . 
3. By the way of derogation from Article 8 6(b)(iv), consignments of semen, oocytes 
and embryos of bovine animals shall be permitted to enter the Union if a donor 
animal comes from an establishment which is not free from infectious bovine 
rhinotracheitis/infectious pustular vulvovaginitis and provided that the official 
veterinarian responsible for the establishment of origin has certified that there has 
been  no clinical case of infectious bovine rhinotracheitis/infectious pustular 
vulvovaginitis during a period of at least the preceding 12 months .  
EN 66  EN Chapter 3  
Specific animal health requirements for germinal products of 
porcine animals  
Article 89 
The establishme nt of origin of donor porcine animals  
1. Consignments of semen , oocytes and embryos of porcine animals shall only be 
permitted to enter the Union if they were collected from animals which c ame from 
establishments : 
(a) which comply with the requirements lai d down  in Article 2 3; 
(b) in the case of donor animals of semen prior their admission to a quarantine 
accommodation, in which no clinical, serological, virological or pathological 
evidence of infection with Aujeszky’s disease virus ha d been detected during 
the period of at least the preceding  12 months ;  
2. Consignments of semen of porcine animals shall only be permitted to enter the Union 
if they were collected from animals : 
(a) prior to their admission to a quarantine accommodation, which came from 
establishments  which were free from infection with Brucella abortus, Brucella 
melitensis  and Brucella suis  in accordance with requirements laid down in 
Chapter IV of Part 5 of Annex II to Delegated Regulation (EU) 2019/… as 
regards the appro val of germinal product establishments and the traceability 
and animal health requirements for movements within the Union of germinal 
products of certain kept terrestrial animals [document C(2019)4055 ]; 
(b) which were k ept at a quarantine accommodation whi ch on the da te of 
admission was free of infection with Brucella abortus , Brucella melitensis  and 
Brucella suis  for a period of at least the three months  preceding that date ;  
(c) which were kept in a semen collection centre in which no clinical, serological, 
virological or pathological evidence of infection with Aujeszky’s disease virus 
was reported for the period of at least 30 days prior to the date of admission 
and of at least 30 days imme diately prior to the date of collection;  
(d) which were  kept, since birth or for at least three months prior to  the date of 
entry into the quarantine accommodation, in an establishment in which no 
animals were vaccinated against infection with porcine rep roductive and 
respiratory syndrome virus and no infection with porcine reproductive and 
respiratory syndrome virus was detected within that period.  
Article 9 0 
Specific animal health requirements for donor porcine animals  
Consignments of semen, oocytes or embryos shall only be permitted to enter the Union if they 
were collected from donor porcine animals that:  
(a) comply with the specific animal health requirements laid down in Part 2 and 
Chapters I , II, III  and IV of Part 5 of Annex II to Regulation (EU) 2 019/… as 
regards the approval of germinal product establishments and the traceability and 
animal health requirements for movements within the Union of germinal products of 
certain kept terrestrial animals [document C(2019)4055 ];  
EN 67  EN (b) were not be vaccinated against infection with porcine reproductive and respiratory 
syndrome virus . 
Chapter 4  
Specific animal health requirements for germinal products of 
ovine and caprine animals  
Article 9 1 
The establishment of origin of donor ovine and caprine animals  
Consignm ents of semen , oocytes and embryos of ovine and caprine animals shall only be 
permitted to enter the Union if they were collected from donor animals which:  
(a) did not come from an establishment, nor been in contact with animals from an 
establishment, in t he case of a kept donor animal of semen prior to its admission to a 
quarantine accommodation, which has been subjected to movement restrictions as 
regards infection with Brucella abortus, Brucella melitensis and Brucella suis . The 
movement restrictions con cerning the establishment are lifted after the period 
comprising at least 42 days  from the date of the slaughter and the disposal of the last 
animal infected or susceptible to that disease;   
(b) come from an establishment, that was free from infection with  Brucella abortus, 
Brucella melitensis and Brucella suis  and has never been kept previously in any 
establishment of a lower status.  
Article 9 2 
Specific animal health requirements for donor ovine and caprine animals  
Consignments of semen, oocytes or embryo s of ovine and caprine animal  shall only be 
permitted to enter the Union if they were collected from donor animals that fulfil specific 
animal health requirements laid down in Part 3 and Chapters I, II and III of Part 5 of Annex II 
to Regulation (EU) 2019/… as regards the approval of germinal product establishments and 
the traceability and animal health requirements for mov ements within the Union of germinal 
products of certain kept terrestrial animals [document C(2019)4055 ]. 
Chapter 5  
Specific animal health requirements for germinal products of 
equine animals  
Article 9 3 
The establishment of origin of donor equine animals  
Consignments of semen , oocytes and embryos of equine animals  shall only be permitted to 
enter the Union  if they were collected from donor animals which come from establishments 
which comply with the requirements laid down in Article 23. 
Article 9 4 
Specific animal health requirements for donor equine animals  
Consignments of semen, oocytes or embryos  of equine animals  shall only be permitted to 
enter the Union if the donor animals of those germinal products comply with the requirements 
laid down Article 2 4(1)(a)(ii) and (b)(ii) and Article 2 4(3), and the additional specific animal  
EN 68  EN health requirements laid down in Part 4 of Annex II to Regulation (EU) 2019/… as regards 
the approval of germinal product establishments and the traceability and animal health 
require ments for movements within the Union of germinal products of certain kept terrestrial 
animals [document C(2019)4055 ]. 
Chapter 6  
Special rules for germinal products of ungulates intended for 
confined establishments  
Article 9 5 
Germinal products intended for confined establishments in the Union  
Consignments of semen, oocytes and embryos of bovine, porcine, ovine, caprine and equine 
animals dispatched from confined establishments in third countries or territories listed in 
accordance with Article 29 shall only be permitted to enter the Union if they are dispatched  to 
a confined establishment in the Union  subject to compliance with the following requirements : 
(a) an assessment was carried out by the competent authority of the Member State of 
destination of the ri sks associated with the entry into the Union of those germinal 
products;  
(b) the donor animals of those germinal products originate from a confined 
establishment in the third country or territory of origin or zone thereof, which is 
included in a list esta blished in accordance with Article 29 of confined 
establishments from which the entry of ungulates into the Union may be authorised;  
(c) the germinal products are destined to a confined establishment in the Union, which is 
approved in accordance with Article 95 of Regulation (EU) 2016/429 ;  
(d) the germinal products are transported directly to the confined establishment referred 
to in point (c).  
Article 9 6 
Specific animal health requirements for donor animals kept in confined establishment  
Consignments of the germinal products referred to in Article 9 5 shall be only permitted to 
enter the Union if they were collected  from donor animals that comply with the following 
requirements :  
(a) the donor animals did not come from an establishment, nor been in contact  with 
animals from an establishment, situated in a restricted zone established due to the 
occurrence of a category A disease or of an emerging disease relevant for the bovine, 
porcine, ovine, caprine or equine animals ;  
(b) the donor animals come from an e stablishment where none of the category D 
diseases relevant for bovine, porcine, ovine, caprine or equine animals have been 
reported for a period of at least 30 days prior to the date of collection of the semen, 
oocytes or embryos ; 
(c) the donor animals  remained in a single confined establishment of origin for a period 
of at least 30 days prior to the date of collection of semen, oocytes or embryos  
intended for entry into the Union and during the period of that collection ; 
(d) the donor animals were clinically examined by the establishment veterinarian  
responsible for the activities carried out at confined establishment , and showed no  
EN 69  EN symptoms suggesting the presence of any of the diseases referred to in point (b) or  
disease symptoms  of such diseases,  on the day the semen, oocytes or embryos were 
collected;  
(e) as much as possible, the donor animals were not used for natural breeding during a 
period of at least 30 days prior to the date of first collection of semen, oocytes or 
embryos intended for entr y into the Union and during the period of that collection;  
(f) the donor animals are identified in accordance with  Article 2 1. 
Article 9 7 
The requirements for germinal products obtained in confined establishments  
Consignments of  germinal products referred to in Article 9 5 shall only be permitted to enter 
the Union if they  are:  
(a) marked in accordance with the information requirements provided for in point (a) of 
Article 8 3;  
(b) transported in accordance with Articles 8 4 and 8 5. 
TITLE  2 
ANIMAL  HEALTH  REQUIREMENTS  FOR  HATCHING  EGGS  
OF POULTRY  AND  CAPTIVE  BIRDS  
Chapter 1  
Animal health requirements for hatching eggs  
Article 98 
The residency period  
Consignments of hatching eggs shall only be permitted to enter the Union if, immediately 
prior to the date of loading of the hatching eggs for dispatch  to the Union the flock of origin 
of the hatching eggs has complied,  for a continuous period of time, with the residency periods 
requirements set out in Annex 22 , and during that time  the flock of origin has:  
(a) remained in the third country or territory of origin or zone thereof;  
(b) remained in the establishment of origin, and no animals have been introduced into 
that establishment during that period of time before loading;  
(c) had no contact with poultry or hatching eggs of a lower health status, or with  captive 
birds or wild birds.  
Article 99 
Handling of hatching eggs during transport to the Union  
Consignments of hatching eggs shall only be permitted to enter the Union if they comply with 
the following requirements :  
(a) the hatching eggs intended for entry into the Union must not have come into contact 
with poultry, captive birds or  hatching eggs not intended for entry into the  Union or 
of a lower health status from the time of loading at the establishment of origin for 
dispatch to the Union until the time of arrival in the Union ;  
EN 70  EN (b) the hatching eggs must not have been transported, unloaded in, or moved to another 
means of transport when transported by road, by sea or by air through a third country 
or territory or zone thereof which is not listed  for the entry of the particular species 
and category of hatch ing eggs into the Union.   
Article 100 
 Derogation and additional requirements for transhipment of hatching eggs in case of an 
incident in the means of transport by waterway or by air  
By way of derogation from point (b) of Article 99, consignments of hatch ing eggs which have 
been transhipped from the means of transport of dispatch into another means of transport for 
onward travel in a third country or territory or zone thereof which is not listed for the entry of 
hatching eggs into the Union, shall only be permitted to enter the Union if the transhipment 
took place  because of the occurrence  of a technical problem or another unforeseen incident 
causing logistic problems during the transport of the hatching eggs to the Union by sea or by 
air, in order to compl ete the transport to the point of entry into Union, and provided that:  
(a) the entry into the Union of the hatching eggs is authorised by the competent authority 
of the Member State of destination and, where applicable , the Member States of 
passage ;  
(b) the transhipment was supervised by an official veterinarian or the responsible 
customs officer and throughout the operation:  
(i) effective measures were put in place to avoid any direct or indirect contact 
between the hatching eggs intended for entry into the Union and any other 
hatching eggs or animals;  
(ii) the hatching eggs were transferred directly and as quick as possible to the 
vessel or aircraft to be used for onward travel, which must comply with 
requirements laid down in Article 17,  without leaving  the premises of the port 
or airport ; 
(c) the hatching eggs are accompanied by a declaration from the competent authority of 
the third country or territory where the transfer took place, providing the necessary 
information on the transfer operation and att esting that the relevant measures were 
put in place to comply with the requirements laid down in points (a) and (b).  
Article 101 
Transport  by vessel  of hatching eggs  
1. Consignments of hatching eggs shall only be permitted to enter the Union if they 
compl y with the following requirements :  
(a) hatching eggs which were transported by ship, even for part of the journey, to 
the Union must : 
(i) have remain ed on board the vessel  during the whole transport;  
(ii) have not been in contact with birds or other hatching eggs of a lower 
health status while on board  the vessel .  
(b) hatching eggs transported in accordance with point (a) must be accompanied 
by a declaration, providing the following information:  
(i) the port of departure in the third country  or territory of origin or zone  
thereof ;  
EN 71  EN (ii) the port of arrival in the Union;  
(iii) where the vessel  called at ports outside the third country  or territory of 
origin or zone of department of the consignment, indicating the ports of 
call; 
(iv) that the hatching eggs complied  during the transport with the 
requirements set out in  point (a) and (i), (ii) and (iii) of this point . 
2. The operator responsible for the consignment of hatching eggs shall ensure that t he 
declaration provided for in paragraph 1, is attached  to the animal health certificate 
and signed by the master of the vessel  at the port of arrival on the day of arrival of 
the vessel . 
Article 102 
Preventive measures for the means of transport  and the containers of hatching eggs  
Consignments of  hatching egg s shall only be permitted to enter the Union if the comply with 
the following requirements :  
(a) the hatching eggs must have been transported in vehicles which:  
(i) are constructed in such a way that hatching eggs cannot fall out;  
(ii) have  been designed to allow cleaning and disinfection;  
(iii) have  been cleaned and disinfected with a disinfectant authorised by  the 
competent authority of the third country or territory of origin , immediately 
before  every transport of, hatching eggs or any it em representing an animal 
health risk, and, if necessary, disinfected again and in any case dried or allowed 
to dry before any new loading of hatching eggs . 
(b) the hatching eggs must have been transported in containers which comply with the 
following requ irements:  
(i) the requirements of point (a) ; 
(ii) they contain only hatching eggs of the same species, category and type which 
come from the same establishment;   
(iii) they were closed in accordance with the instructions of the competent authority 
of the t hird country or territory of origin to avoid any possibility of substitution 
of the content;  
(iv) they were : 
– cleaned and disinfected before loading in accordance with the 
instructions of the competent authority of the third country or territory of 
origin ; or 
– they are disposable, clean and used for the first time;  
(v) they bear the information for the particular species and  category of hatching 
eggs set out in Annex 16. 
Article 103 
Movement and handling of hatching eggs after the entry  
Following  their entry into the Union , operators, including transporters, shall ensure that 
consignments of hatching eggs  are:  
EN 72  EN (a) transported directly from the point of  arrival  to their place of destination  in the 
Union ; 
(b) comply with the requirements for movement within the Union and handling 
following their entry into the Union as laid down for the particular species and 
category  of hatching eggs  origin  in Chapter s 5 and 7 of this Title . 
Chapter 2  
Specific animal health re quirements for hatching eggs of poultry  
Article 104 
Hatching eggs originating from poultry imported into the third country  or territory of origin 
or zone thereof  
Consignments of hatching eggs of poultry , which originate from  flocks which were imported 
into the third country, or territory of origin  or zone thereof from another third country or 
territory or zone thereof, shall only be permitted to enter the Union if the competent authority 
of the third country or territory of origin of the hatching eggs  has provided guarantees  that: 
(a) the flocks of origin of the hatching eggs were imported from a third country or 
territory or zone thereof, which is listed for the entry into Union of such flocks ;  
(b) the import of the flocks of origin of t he hatching eggs into that third country or 
territory or zone thereof took place in accordance with animal health requirements 
that are at least as stri ngent as if they were directly entered into the Union.  
Article 105 
The third country or territory of ori gin or zone thereof of the hatching eggs  
Consignments of hatching eggs of poultry shall only be permitted to enter the Union if they 
originate  from a third country or territory or zone thereof  which complies which the following 
requirements :  
(a) it has a disease surveillance programme  for highly pathogenic avian influenza in 
place for a period of at least six months prior to the date of dispatch of the 
consignment to the Union and that surveillance programme complies with the 
requirements  laid down in eith er: 
(i) Annex 2  to this Regulation ;  
or 
(ii) relevant Chapter of the Terrestrial Animal Health Code of the World Animal 
Health Organisation (OIE);  
(b) which is considered to be free from highly pathogenic avian influenza in accordance 
with Article 3 8; 
(c) where it carries vaccination against highly pathogenic avian influenza , the competent 
authorit y of the third country or territory of origin has provided guarantees that: 
(i) the vaccination programme complies with the requirements set out in Annex 
13;  
(ii) the surveillance programme referred to in point (a)  of this Article , in addition 
to the requirements  set out in Annex 2,  complies with  the requirements set out 
in Part 2 of Annex 13;   
EN 73  EN (iii) it has undertaken to inform the Commission of any change to th e vaccination 
programme  in the third country or territory or zone thereof ; 
(d) which:  
(i) in the case of hatching eggs of poultry other than ratites, is considered to be 
free from infection with Newcastle disease virus in accordance with Article 39; 
(ii) in the case of hatching eggs of ratites:  
– it is considered to be free from infection with Newcastle disease virus in 
accordance with Article 39;  
or  
– it is not considered to be free from infection with Newcastle disease virus  
in accordance with Article 39 , but the competent authority of the third 
country or territory of origin has provided  guarantees  regarding  
compliance with the requirements for infection with Newcastle disease 
virus  in relation to isolation, surveillance and testing, as set out in Annex 
14; 
(e) where vaccination against infection with Newcastle disease virus is carried out , the 
competent authorit y of the third country or territory ha s provided guarantees that: 
(i) the vaccines used comply with the general and the specific criteria for vaccin es 
against infection with Newcastle disease virus set out in Part 1 of Annex 15 ;  
or 
(ii) the vaccines used comply with the general criteria for vaccines against 
infection with Newcastle disease virus set out in Part 1 of Annex 15  and the 
poultry meet the animal health requirements  for poultry and hatching eggs 
originating from a third country or territory or zone thereof where vaccines 
used against infection with Newcastle disease virus do not meet the specific 
criteria set out in Part 1  of Annex 15, set out in Part 2 of Annex 15 ; 
(f) it has undertaken that f ollowing  any outbreak of highly pathogenic avian influenza or 
an outbreak of infection with Newcastle disease virus , to submit the following 
information to the Commission:  
(i) information on the disease  situation within 24 hours of confirmation of any 
initial outbreak of highly pathogenic avian influenza  or infection with 
Newcastle disease virus ; 
(ii) regular updates of the disease situation;   
(g) which has undertaken to submit v irus isolates from initial outbreak s of highly 
pathogenic avian influenza or infection with Newcastle disease virus to the European 
Union Reference Laboratory for Avian Influenza and  Newcastle diseas e.  
Article 106 
The establishment of origin of the hatching eggs  
Consignment s of hatching eggs of poultry  shall only be permitted to enter the Union if they 
originate  from:  
(a) hatcheries approved  by the competent authority of the third country or territory of 
origin in accordance with requirements which are at least as stringent  as those laid  
EN 74  EN down in Article 7 of Regulation (EU) 2019/… [ reference to DA on registration of 
establishments and identification of animals ]; and 
(i) the approval of which has not been suspended or withdrawn;  
(ii) within a 10 km radius of  those hatcheries , including, where appropriate, the 
territory of a neighbouring country, there has been no outbreak of highly 
pathogenic avian influenza or infection with Newcastle disease virus for a 
period of at least 30 days  prior to the time  of loading  of the hatching e ggs for 
dispatch to the Union ; 
(iii) which  have been assigned a unique approval number by the competent 
authority of the third country or territory of origin ; 
(b) flocks which have been kept in establishments  approved by the competent authority 
of the third country or territory of origin in accordance with requirements which are 
at least equivalent to  those laid down in Article 8 of Regulation (EU) 2019/… 
[reference to DA on registration of establishments and identification of animals ] and 
(i) the appro val of which has not been suspended or withdrawn;  
(ii) within a 10 km radius of those establishments , including, where appropriate, 
the territory of a neighbouring country, there has been no outbreak of highly 
pathogenic avian influenza or infection with N ewcastle disease virus for a 
period of at least 30 days  prior to the time of collection of the hatching eggs for 
dispatch to the Union ; 
(iii) no confirmed case of infection with low pathogenic avian influenza viruses has  
been reported  in those establishmen ts within a period of at least 21 days prior 
to the time of collection of the eggs for dispatch  to the Union ; 
(iv) which  have been assigned a unique approval number by the competent 
authority of the third country or territory of origin . 
Article 107 
The flock of origin of the hatching eggs  
Consignments of hatching eggs of poultry shall only be permitted to enter the Union if they  
originate from flocks which comply with the following requirements:  
(a) where they have been vaccinated against highly pathogen ic avian influenza, 
guarantees for compliance with the minimum requirements for vaccination 
programmes and additional surveillance set out in Annex 13 , have been provided by 
the third country or territory of origin;  
(b) where they have been vaccinated agai nst infection with Newcastle disease virus:  
(i) guarantees have been provided by the competent authority of the third country 
or territory of origin that the vaccines used comply with:  
– the general and the specific criteria for vaccines against infection wi th 
Newcastle disease virus set out in Part 1 of Annex 15 ; or 
– the general criteria for recognised vaccines against infection with 
Newcastle disease virus set out in Part 1 of Annex 15 and the poultry  and 
hatching eggs from which the day -old chicks originate d meet the animal 
health requirements for poultry and hatching eggs originating from a 
third country or territory or zone thereof where vaccines used against  
EN 75  EN infection with Newcastle disease virus do not meet the specific criteria 
set out in Part 1  of Annex 15  set out in Part 2 of Annex 15 ; 
(ii) the information set out in Part 4 of Annex 15 must  be provided for each 
consignment;  
(c) they have undergone a disease surveillance programme  that meets the requirement 
set out Annex II of Regulation (EU) 20 19/… [ reference to DA on registration of 
establishments and identification of animals ] and were found not to be infected or 
showed any grounds for suspecting any infection by the following agents:  
(i) Salmonella  Pullorum, Salmonella  Gallinarum and Mycoplas ma gallisepticum 
in case of Gallus gallus ; 
(ii) Salmonella  arizonae (serogroup O:18(k)), Salmonella  Pullorum, Salmonella  
Gallinarum, Mycoplasma  meleagridis and Mycoplamsa  gallisepticum in case of 
Meleagris gallopavo ; 
(iii) Salmonella Pullorum and Salmonella Gallinarum in case of Numida meleagris, 
Coturnix coturnix, Phasianus colchicus, Perdix perdix, Anas spp.;  
(d) they have been subjected to a clinical inspection, carried out by an official 
veterinarian in the third country or territory or origin or zone thereof, within a period 
of 24 hours  prior to the time of loading  of the consignment of hatching eggs for 
dispatch to the Union for the purpose of the detection of signs indicative of the 
occurrence of diseases, including the relevant listed diseas es referred to  in Annex 1 
and emerging diseases and they showed no disease symptoms  or grounds for 
suspecting the presence of any of those disease s.  
Article 108 
The hatching eggs of the consignment  
Consignments of  hatching eggs of poultry  shall only be p ermitted to enter the Union if they 
comply with the following requirements:  
(a) if the hatching eggs  have been vaccinated against highly pathogenic avian influenza , 
guarantees for compliance with the minimum requirements for vaccination 
programmes and additional surveillance set out in Annex 13 , have been provided by 
the third country or territory of origin;  
(b) if the hatching eggs  have been vaccinated against infection with Newcastle disease 
virus:  
(i) guarantees have been provided by the competent authority of the third country 
or territory of origin that the vaccines used comply either with :  
– the general and the specific criteria for vaccines against infection with 
Newcastle disease virus  set out i n Part 1 of Annex 15 ; 
or 
– the general criteria for vaccines against infection with Newcastle disease 
virus set out in Part 1 of Annex 15  and the hatching eggs meet the animal 
health requirements for poultry and hatching eggs originating from a 
third country  or territory or zone thereof where vaccines used against 
infection with Newcastle disease virus do not meet the specific criteria 
set out in Part 1  of Annex 15  set out in Part 2 of Annex 15 ;  
EN 76  EN (ii) the information set out in Part 4 of Annex 15 must be provi ded for the 
consignment;  
(c) the hatching eggs must be marked:  
(i) using colour ink;  
(ii) in the case of hatching eggs of poultry other than ratites, with a stamp 
indicating the  unique  approval number  of the  establishment of origin  referred 
to in Article 106; 
(ii) in the case of hatching eggs of ratites, with a stamp indicating the ISO code of 
the third country or territory of origin and the unique  approval number of the  
establishment of origin  referred to in Article 106 ; 
(d) the hatching eggs must have be en disinfected in accordance with the instructions of 
the competent authority of the third country or territory of origin.  
Article 109 
Entry of hatching eggs into Member States with  status free from infection with Newcastle 
disease virus  without vaccinatio n 
Consignments of  hatching eggs intended for a Member State with status free from infection 
with Newcastle disease virus  without vaccination , shall only be permitted to enter the Union 
if they originate from flocks which  comply with the requirements set ou t in one of the 
following points : 
(a) they have not been vaccinated against infection with Newcastle disease virus;  
or 
(b) they have been vaccinated against infection with Newcastle disease virus using an 
inactivated vaccine;  
or 
(c) they have been vaccinated against infection with Newcastle disease virus using a live 
vaccine at the  latest within the period of 60 days  prior to the time of collection of the 
eggs. 
Chapter 3  
Specific animal health requirements for consignments of less than 
20 hatching eggs of poultry other than ratites  
Article 110 
Derogation s and special requirements for consignments of less than 20 hatching eggs of 
poultry other than ratites  
By way of derogation from Articles 10 1, 102, 106, 107 and 10 8, consignments of less than 20 
hatching eggs of poultry other than ratites  shall be permitted to enter the Union if they comply 
with the following requirements:  
(a) they come from establishments:  
(i) registered by the competent authority of the third country or territory of origin;   
EN 77  EN (ii) where no confirmed case of infection  with low pathogenic avian influenza 
viruses was reported  within the period of 21 days prior to the time of collection 
of the hatching eggs ; 
(iii) within a 10 km radius of the establishments , including, where appropriate, the 
territory of a neighbouring country, there has been no outbreak  of highly 
pathogenic avian influenza or infection with Newcastle disease virus for a 
period of at least 30 days  prior to the time of collection of the hatch ing eggs . 
(b) in relation to vaccination against highly pathogenic avian influenza : 
(i) the hatching eggs  have not been vaccinated against highly pathogenic avian 
influenza;  
(ii) where the flocks of origin have been vaccinated against highly pathogenic 
avian influenza , guarantees for compliance with the minimum requirements for 
vaccination programmes and additional surveillance set out in Annex 13 , have 
been provided by the third country or territory of origin;  
(c) where the flock of origin  has been vaccina ted against infection with Newcastle 
disease virus :  
(i) guarantees have been provided by the competent authority of the third country 
or territory of origin that the vaccines used comply either with: 
– the general and the specific criteria for vaccines against infection with 
Newcastle disease virus set out in Part 1 of Annex 15 ; or 
– the general criteria for recognised vaccines against infection with 
Newcastle disease virus set out in Part 1 of Annex 15  and the hatching 
eggs meet the animal health requirements for poultry and hatching eggs 
originating from a third country or territory or zone thereof where 
vaccines used against infection with Newcastle disease virus do not meet 
the specific criteria set out  in Part 1  of Annex 15, set out in Part 2 of 
Annex 15 ; 
(ii) the information set out in Part 4 of Annex 15 must be provided for the 
consignment;  
(d) they come from flocks  which have been subjected to a clinical inspection, carried out 
by an official veterin arian in the third country or territory or origin or zone thereof, 
within 24 hours prior to the time of loading  of the consignments of hatching eggs for 
dispatch shipment to the Union for the purpose of the detection of signs indicative of 
the occurrence o f diseases, including the relevant listed diseases referred to  in Annex 
1 and emerging diseases and the flocks showed no disease symptoms  or grounds for 
suspecting the presence of any of those  disease s; 
(e) they come from  flock s which :  
(i) have been  isola ted on the establishment of origin for a period of at least 21 
days prior to  the collection of the eggs;  
(ii) were found not to be infected or showed any grounds for suspecting any 
infection by the following agents , in tests performed  in accordance with the 
requirements for testing of consignments of less than 20 heads of poultry other 
than ratites and less than 20 hatching eggs thereof before the entry into the 
union , set out in Annex 17:   
EN 78  EN – Salmonella  Pullorum, Salmonella  Gallinarum and Mycoplasma  
gallisep ticum in case of Gallus gallus ; 
– Salmonella  arizonae (serogroup O:18(k)), Salmonela Pullorum, 
Salmonella  Gallinarum, Mycoplasma  meleagridis and Mycoplasma  
gallisepticum in case of Meleagris gallopavo ; and  
– Salmonella  Pullorum and Salmonella  Gallinarum in cas e of Numida 
meleagris, Coturnix coturnix, Phasianus colchicus, Perdix perdix, Anas 
spp. 
Chapter 4  
Specific animal health requirements for specified pathogen -free 
eggs 
Article 111 
Derogation and special requirements for specified pathogen -free eggs  
By way of derogation from the residency period requirements of Article 9 8, the specific 
animal health requirements of Articles 10 5 to 11 0 and Articles 112 to 114 , consignments of 
specified pathogen -free eggs which do not comply with the animal health requi rements  laid 
down in those provisions , shall be permitted to enter the Union if they comply instead with 
the following animal health requirements:  
(a) they originate from flocks  which:  
(i) are free from specified pathogens as described in the European Pharmacopoeia  
and the results of all tests and clinical examinations required for this specific 
status have been favourable, including negative testing results for highly 
pathogenic avian influenza , infection with Newcastle disease virus and 
infection with  low pathogenic avian influenza viruses  carried out within the 
period of 30 days prior to the time of collection of the eggs for dispatch  to the 
Union ; 
(ii) have been clinically examined at least once a week as described in the 
European Pharmacopoeia and n o disease symptoms  or ground for suspecting 
the presence of any disease were detected;  
(iii) have been kept for a period of at least 6 weeks  prior to  the time of collection of 
the eggs for dispatch to the Union  in establishments which comply with the 
condi tions described in the European Pharmacopoeia;  
(iv) have had no contact with poultry not meeting the requirements of this Article 
or with wild birds for a period of at least 6 weeks prior to the time of collection 
of the eggs  for dispatch to the Union ; 
(b) they have been marked using colour ink with a stamp bearing the ISO code of the 
third country or territory of origin and the approval number of the establishment of 
origin;  
(c) they have been disinfected in accordance with the instructions of the competent 
author ity of the third country or territory of origin.   
EN 79  EN Chapter 5  
Specific animal health requirements for movement and handling 
of hatching eggs of poultry after entry into the Union and of 
poultry hatched from those eggs  
Article 112 
Obligations on operators as regards h andling of hatching eggs following their entry into the 
Union and of poultry hatched from those hatching eggs  
1. Operators at the establishment of destination shall place hatching eggs of poultry  
which have entered into the Union from a third coun try or territory or zone thereof  
either in: 
(a) separate incubators and hatchers from other hatching eggs;  
or 
(b) incubators and hatchers where other hatching eggs are already present.  
2. Operators, as referred to in paragraph 1, shall ensure that breedin g poultry and 
productive poultry which have been hatched from hatching eggs  referred to in that 
paragraph , are kept for a continuous period of time:  
(a) in the hatchery  for a period of at least 3 weeks from the date of hatching;  
or  
(b) on the establishm ents to which the poultry has been sent after hatching, either 
in the same Member State or in another Member State, for a period of at least 3 
weeks  from  the date of hatching .  
3. During the periods provided for in paragraph 2, operators shall keep poultry, which 
have been hatched from hatching eggs that have entered into the Union, separate 
from other flocks of poultry.  
4. Where breeding poultry and productive poultry , which have been hatched from 
hatching eggs that have entered into the Union from a third country or territory or 
zone thereof , were introduced into premises or enclosures where other poultry are 
present, the relevant periods provided for  in paragraph 2 shall commence from the 
date of introduction of the last bird and no poultry shall b e moved from the premises 
or enclosures before the end of those periods.  
5. Where hatching eggs of poultry, which have entered into the Union from a third 
country or territory or zone thereof, were introduced in incubators and hatchers 
where other hatching  eggs were already present:  
(a) the provisions of paragraphs 2 to 4 shall apply to all poultry hatched from the 
hatching eggs in the same incubator or hatcher as the hatching eggs which have 
entered into the Union from a third country or territory or zone ther eof; 
(b) the relevant periods referred to in paragraph 2 shall commence from the date of 
hatching of the last hatching egg that has entered into the Union from a third 
country or territory or zone thereof.   
EN 80  EN Article 113 
Sampling and testing following the entry into the Union  
Breeding poultry and productive poultry which have been hatched from hatching eggs that 
have entered into the Union from a third country or territory or zone thereof must  undergo a 
clinical examinati on carried out by an official veterinarian on the establishment of destination 
no later than the date of expiry of the relevant periods as provided for Article 112(2), and , 
where necessary, shall be sampled for testing to monitor their state of health.  
Article 114 
Obligation on the competent authorities as regards s ampling and testing of ratites from 
hatching eggs originating from a third country or territory or zone thereof not free from 
infection with Newcastle disease virus  
The competent authority of th e Member State of destination shall ensure that ratites which 
have hatched from hatching eggs that have entered into the Union from a third country or 
territory or zone  thereof is not free from infection with Newcastle  disease virus, during the 
periods provided for in Article 112(2):  
(a) they undergo a virus detection test for infection with Newcastle disease virus carried 
out by the competent authority on a cloacal swab or faeces sample from each ratite ;  
(b) in the case of ratites destined for a Member St ate with status free from infection with 
Newcastle disease virus without vaccination , in addition to the requirements referred 
to in point (a) , they shall be subject to a serological test for infection with Newcastle 
disease virus carried out by the compet ent authority on each ratite ;  
(c) all ratites shall have tested negative to the tests provided for in points (a) and (b)  
prior to their release from isolation . 
Chapter 6  
Specific animal health requirements for hatching eggs of captive 
birds  
Article 115 
The hatching eggs of the consignment  
Consignments of h atching  eggs of captive birds shall only be permitted to enter the Union if 
they were obtained  from captive birds which comply with the requirements for entry into the 
Union set out in Article s 55 to 58 . 
Chapter 7  
Specific animal health requirements for movement and handling 
of hatching eggs of captive birds after entry into the Union and of 
poultry hatched from those eggs  
Article 116 
Handling of hatching eggs of captive birds following their entry into the Union and of captive 
birds hatched from those hatching eggs  
Operators  at the establishment of destination shall :  
EN 81  EN (a) place the hatching eggs of captive  birds which have entered into the Union from a 
third country or territory  or zone thereof in separat e incubators and hatchers from 
other hatching eggs ; 
(b) ensure that captive birds which are hatched from the hatching eggs of captive birds 
referred to in Article 11 5 are kept in a n approved quarantine establishment  in 
accordance with the requirements of Articles 59 to 62. 
TITLE 3 
ANIMAL HEALTH REQUIR EMENTS FOR GERMINAL PRODUCTS OF 
ANIMALS OTHER THAN U NGULATES AND OTHER T HAN HATCHING 
EGGS OF POULTRY AND CAPTIVE BIRDS  INTENDED FOR CONFINE D 
ESTABLISHMENTS  
Article 117 
Requirements for the entry into the Union of consignments  of germinal products  of animals 
other than those referred to in point (g) of Article 1(5) dispatched from confined 
establishments  
Consignments  of semen, oocytes and embryos of animals other than those referred to in point 
(g) of Article 1(5 ) dispatched from confined establishments listed in accordance with Article 
29 shall only be permitted to enter the Union if they are dispatched  to a confined 
establishment located in the Union and provided that : 
(a) an assessment has been carried out by t he competent authority of the Member State 
of destination of the risks that the entry of those germinal products may present for 
the Union;  
(b) the donor animals of those germinal products originate from a third country, territory 
or zone authorised for e ntry into the Union of the particular species and  category of 
animals ;  
(c) the donor animals of those germinal products originate from a confined 
establishment in the third country, territory or zone of origin, which is included in a 
list established in accordance with Article 2 9 of confined establishments from which 
the entry of  animals of specific  species into the Union may be authorised;  
(d) the germinal products are destined to a confined establishment in the Union, which is 
approved in accordance with Article 95 of Regulation (EU) 2016/429 ;  
(e) the germinal products are tra nsported directly to the confined establishment referred 
to in point (d).  
Article 118 
Specific animal health requirements for donor animals  
Consignments  of semen, oocytes and embryos referred to in Article 117 shall only be 
permitted to enter the Union if they were collected from d onor animals which comply with the 
following requirements :  
(a) they do not come from an establishment, nor have been in contact with animals from 
an establishment, situated in a restricted zone established due to the occurrence o f a 
category A disease or of an emerging disease relevant for the species of those kept 
terrestrial animals;   
EN 82  EN (b) they come from an establishment where no category D disease relevant for the 
species of those kept terrestrial animals has been reported for a period of at least the 
preceding 30 days;  
(c) they have remained in a single confined establishment of origin for a period of at 
least 30 days prior to the collection of the semen, oocytes or embryos  intended for 
the entry into the Union ; 
(d) they have been clinically examined by the establishment veterinarian  responsible for 
the activities of the confined establishment , and showed no symptoms suggesting the 
presence of any of the diseases referred to in point (b) or clinical signs of such 
diseases, on t he day the semen, oocytes or embryos were collected;  
(e) as much as possible, they were not used for natural breeding during a period of at 
least 30 days prior to the date of first collection and during the period of collection of 
semen, oocytes or embryos  intended for entry into the Union;  
(f) they are identified and registered in accordance with the rules of that confined 
establishment.  
Article 119 
The requirements for germinal products  
Consignments  of semen, oocytes and embryos referred to in Article 117  shall only be 
permitted to enter the Union if they comply with the following requirements:  
(a) they are marked in such a way that the following information can be readily 
established:  
(i) the date of collection or production of those germinal products;  
(ii) the species , where necessary subspecies, and identification of the donor 
animal(s);  
(iii) the unique approval number  of the confined establishment , which shall include 
the ISO 3166 -1 aplha -2 code of the country in which the approval is granted ; 
(iv) any other relevant information . 
(b) they are transported in the  container which : 
(i) is sealed and numbered prior to the dispatch from the confined establishment 
by the establishment veterinarian  responsible for the activities of the confined 
establishment ; 
(ii) has been cleaned and either disinfected or sterilised before use, or is single -use 
container;  
(iii) has been filled in with the cryogenic agent which not have been previously 
used for other products.  
PART IV  
Animal health requirements for entry into the Union of products 
of animal origin as referred to in Articles 3 and 5   
EN 83  EN TITLE  1 
GENERAL  ANIMAL  HEALTH  REQUIREMENTS  FOR  ENTRY  
INTO  THE  UNION  OF PRODUCTS  OF ANIMAL  ORIGIN   
Article 120 
Time constrains for the date o f production  
1. Consignments of  products of animal origin  shall only be permitted to enter the Union 
if they  were not obtained  during a period where:  
(a) animal health restriction measures were adopted by the Union for the entry of 
such products from the third country or territory of origin  or zone thereof ; 
(b) the authorisation for the entry into the Union of such products from the third 
country or territory of origin or zone thereof  was suspended.  
Article 121 
Treatment requirements for products of anima l origin  
1. Consignments of p roducts of animal origin, other than fresh or raw, shall only be 
permitted to enter the Union if they  have been treated in accordance with  Titles 3 to 
6 of this Part.  
The treatment referred to in  the first subparagraph must ha ve been : 
(a) specifically assigned  by the Union  in the list , to the third country or territory of 
origin or zone thereof  and to  the species of origin of the product of animal 
origin;  
(b) applied in a third country or territory or zone thereof listed  for the entry into 
the Union of the particular species and  category of products of animal origin;   
(c) applied in accordance with requirements for : 
(i) risk mitigating treatments for meat products  set out in Annex 26 ; 
(ii) risk mitigating treatments for dairy products  set out in Annex 27; 
(iii) risk mitigating treatments for egg products  set out in Annex 28.  
2. After the completion of the treatment  provided for in paragraph  1, products of animal 
origin must  be handled until packaged in a way to prevent any cross contamination 
that could introduce an animal health risk.   
Article 122 
Requirements concerning the means of transport of the products of animal origin  
Consignments of  products of animal origin shall only be permitted to enter the Union  if they 
were t ransported in a means of transport  designed,  constructed  and maintained  in such a way 
that the health status of the products of animal origin was not jeopardised during the transport  
from their origin to the Union .  
EN 84  EN Article 123 
Dispatch of products of anima l origin to the Union  
Consignments of p roducts of animal origin shall only be permitted to enter  the Union if they 
have been  dispatched to their destination in the Union separated  from animals and products of 
animal origin not complying with the relevant animal health requirements for the entry into 
the Union provided for in this Regulation.  
TITLE  2 
ANIMAL  HEALTH  REQUIREMENTS  FOR  THE  ENTRY  INTO  
THE  UNION  OF FRESH  MEAT   
Chapter 1  
General animal health requirements for fresh meat   
Article 124 
Dispatch of kept animals of origin of the fresh meat to a slaughterhouse  
Consignments of f resh meat of kept animals , except those kept as farmed game that have been 
killed on -the-spot, shall only be permitted to enter the Union if they have been o btained f rom 
kept animals which comply with the following requirements:  
(a) the kept animals were dispatched directly from their establishment of origin to a 
slaughterhouse situated in the same listed third country  or territory or zone ;  
(b) during the transport  to the slaughterhouse referred to in point (a), the kept animals : 
(i) did not pass through a third country  or territory or zone thereof not listed  for 
the entry into the Union of  the particular species and  category of fresh meat;  
(ii) did not come into contact with animals  of a lower health status.  
(c) the means of transport and containers used to transport the kept animals to the 
slaughter house referred to in point (a) comply with the requirements laid down in 
Articles 17 and 18 . 
Article 125 
Dispatch of carcasses of wild  animals  or animals kept as  farmed game  killed on the spot  
Consignments of f resh meat of wild animals or animals kept as farmed game that have been  
killed on -the-spot shall only be permitted to enter the Union if they have been obtained from 
carcasses  which comply with the following requirements:  
(a) the carcasses were  dispatched directly from the place of killing to a game handling 
establishment situated in the same listed third country  or territory or zone ; 
(b) during the transport  to the game handling establishment referred to in point (a), the 
carcasses : 
(i) did not pass through a third country  or territory or zone thereof not listed for  
the entry into the Union of the particular species and category of  fresh meat;  
(ii) did not come into contact with animals or carcasses of a lower health status.  
(c) the carcasses were transported to the game handling establishment referred to in 
point (a) in means of transport and containers which comply with the following 
requiremen ts:  
EN 85  EN (i) they were cleaned and disinfected, with a disinfectant authorised by the 
competent authority of the third country or territory of origin, before the 
loading of the carcasses  for dispatch to the Union ;  
(ii) they were constructed in such a way that the health status of the carcasses was 
not jeopardised during the transport.  
Article 126 
The ante -mortem and post -mortem inspections  
Consignments of f resh meat of kept and wild animals  shall only be permitted to enter the 
Union if they  have been obtained f rom animals which have undergone the following 
inspections:  
(a) in the case of kept animals:  
(i) an ante -mortem inspection within the period of 24 hours prior to the time of 
slaughter;  
(ii) a post -mortem inspection  carried out , without delay, after their killing or 
slaughter.  
(b) in the case of wild animals, a post -mortem inspection  carried out , without delay, after 
their killing.  
The inspections referred to in the first paragraph must have been carried out by an official 
veterinarian in the third country or territory of origin or zone thereof in order to exclude the 
presence of the relevant diseases referred to in Annex 1 and the absence of emerging diseases.  
Article 127 
Handling of the animals of origin of the fresh meat during killing or slaughter  
Consignments of f resh meat shall only be permitted to enter the Union if they originate from 
animals which had no contact with animals of a lower animal health status during their killing 
or slaughter . 
Article 128  
Handling and preparation of fresh meat in the establishment of origin of the fresh meat  
Consignments of f resh meat must be  kept strictly segregated from fresh meat not complying 
with the relevant animal health requirements for the entry into  the Union of fresh meat, 
provided for in  Articles 124 to 14 6, throughout the operations of slaughter, cutting and until  
either : 
(a) it was packed for further storage or dispatch  to the Union ; or 
(b) its arrival to the Union, in the case of unpacked fresh meat.   
EN 86  EN Chapter 2  
Animal health requirements for fresh meat of ungulates  
SECTION 1 
GENERAL ANIMAL HEALT H REQUIREMENTS FOR F RESH MEAT OF KEPT AN D 
WILD UNGULATES  
Article 129 
The species of animals of origin of the fresh meat of ungulates  
Consignments of f resh meat from ungulates shall only be permitted to enter the Union if the 
fresh meat originates from the following species:  
(a) in the case of kept ungulates, from all species of ungulates.  
(b) in the case of wild ungulates  and ungulates kept as farmed gam e, from all species of 
ungulates except from Bos taurus, Ovis aries , Capra hircus  and Equus caballus, not 
including Equus caballus hippotigris  (zebras ). 
Article 130 
Prohibition as regards the entry of fresh blood  
Consignments of fresh blood of ungulates for human consumption shall not be permitted to 
enter the Union . 
SECTION 2 
SPECIFIC ANIMAL HEAL TH REQUIREMENTS FOR FRESH MEAT OF KEPT 
UNGULATES  
Article 131 
The residency period before slaughter or killing of the kept of the kept ungulates of origin of 
the fresh meat  
1. The kept ungulates  of origin of the fresh meat intended for the entry into the Union 
shall  not be required to comply with a residency period prior to the date of slaughter  
or killing  provided that the y were introduced into the third country o r territory  or 
zone thereof  from:  
(a) another third country  or territory  or zone which is listed  for the entry into the 
Union of fresh meat from the same species of ungulates and the kept ungulates 
remained there for at least three months  prior to slaughte r; or 
(b) a Member State.  
2. The kept ungulates of origin of the fresh meat intended for the entry into the Union 
other than those referred to in paragraph 1, must  comply, immediately prior to the 
date of slaughter  or killing , with a residency period for a continuous period of time in 
accordance with Annex 23 where they:  
(a) remained in the third country  or territory of origin or zone  thereof ;  
(b) remained in the establishment of origin;  
(c) had no contact with ungulates of a lower health status.   
EN 87  EN Article 132 
Derogation from direct dispatch of the kept animals  of origin of the fresh meat  to a 
slaughterhouse  
By way of derogation from Article 12 4(a), consignments of fresh meat of kept ungulates not 
complying with those requirements shall be permitted to enter  the Union provided that  the 
fresh meat was obtained from ungulates  of the  species Bos taurus, Ovis aries , Capra hircus  
and Equus caballus,  not including Equus caballus hippotigris  (zebras) , and: 
(a) the ungulates passed through one single establishment conducting assembly 
operations , which complies with the requirements laid down in Article 20(b),  after 
leavi ng their establishment of origin and before their arrival at the slaughterhouse;  
(b) the competent authority of the third count ry or territory of origin has provided 
additional guarantees  to ensure the animal health status of the ungulates during the ir 
movement from their establishment of origin to their arrival at the slaughterhouse has 
not been jeopardised;  
(c) the third countr y, territory or zone thereof referred to in point (b) is authorised in the 
list for such derogation . 
Article 133  
The third country  or territory of origin  or zone thereof of the fresh meat of kept ungulates  
1. Consignments of f resh meat of kept u ngulates shall only be permitted to enter the 
Union if they originate from a third country  or territory or zone thereof which 
complies with the minimum periods of disease freedom  set out in the table in Part A 
of Annex 24 , for the referred listed  diseases, for which  the species of ungulate s from 
which the fresh meat has been obtained are listed.  
The minimum periods referred to in the first sub paragraph may be reduced for the 
diseases listed in Part B of Annex 24 subject to compliance with the specific 
conditions  provided for therein ; these specific conditions must be specifically 
assigned by the Union in the list, to that third country or territory or zone thereof and 
to the particular species of origin of the fresh meat.  
2. Consignments of f resh meat of u ngulates  shall only be permitted to enter the Union if 
they originate from a third country  or territory or zone thereof in which vaccination 
against listed diseases referred to in paragraph 1 has not been carried out according 
to the table in Part A of Annex 25 . 
3. By way of derogation of paragraph 2, vaccination against foot and mouth disease 
may have been carried out subject to compliance with the  specific conditions  to be 
provided by the competent authority  provided for  in points 1.1(b) or 3.1.1(a) in Part 
B of Annex 25 which must be specifically assigned by the Union  in the list , to that 
third country or territory or zone thereof and to the particular species of origin of the 
fresh meat.  
Article 134 
The establishment of origin  of the kept ungulates from which th e fresh meat has been obtained  
1. Consignments of f resh meat of kept ungulates shall only be permitted to enter the 
Union if they have been obtained from ungulates which come from an establishment:  
(a) in and around which, including where appropriate the territory of a 
neighbouring country, no case or outbreak of the listed diseases referred to in  
EN 88  EN Part A of Annex 24 , for which the species of ungulates of origin of the fresh 
meat intended for the entry in to the Union are listed, has been reported in an 
area of 10 km radius and for a period of 30 days  prior to the date of slaughter ; 
or 
(b) which complies with the specific conditions to be provided by the competent 
authorities where vaccination against foot and mouth disease has been carried 
out in the third country or territory or zone thereof less than 12 months  before 
the date of slaughter  set out in points 1.1(b) or 3.1.1(a) of Part B of Annex 25  
which must have been specifically assigned by the Commission  in the list to 
the third country or territory or zone thereof authorised for the entry into the 
Union of fresh meat of ungulates  and to the species of origin of the fresh meat . 
2. Consignments of fresh meat of kept ungulates shall only be permitted to enter the 
Union if they have been obtained from ungulates which come from an establishment :  
(a) where  no animals have been vaccinated according to Part A of Annex 25 ; or 
(b) the third country  or territory of origin or zone thereof complies with the 
specific conditions  to be provided by the competent authorit y where the third 
country or territory or zone thereof has been free of disease for less than 12 
months  befor e the date of slaughter,  set out in point 1 of Part B of Annex 24 , 
which must have been specif ically assigned by the Commission  in the list to 
the third country  or territory or zone thereof listed  for the entry into the Union 
of fresh meat of ungulates  and to the species of origin of the fresh meat .  
Article 135 
Specific requirement for fresh meat obtaine d from kept ungulates of the species Sus scrofa  
Consignments of f resh meat of kept ungulates of the species Sus scrofa  shall only be 
permitted to enter the Union if they  originate from animals which have been kept separated 
from wild ungulates since birth.   
Article 136 
The establishment of origin of the fresh meat  of kept ungulates  
Consignments of f resh meat of kept ungulates shall only be permitted to enter the Union if 
they were obtained  in a slaughterhouse, or in a game handling establishment, in and around 
which there has been no case or outbreak of the listed diseases referred to in Part A of Annex 
24 in an area of 10 k ilometres , including, where appropriate, the territory of a neighbouring 
country, for a period of 30 days  prior to the date of slaughter  or to the date of killing . 
SECTION 3 
SPECIFIC ANIMAL HEAL TH REQUIREMENTS FOR FRESH MEAT OF WILD 
UNGULATES  
Article 137 
The country  or territory of origin or zone  thereof  of the fresh meat of wild ungulates  
Consignm ents of f resh meat of wild ungulates shall only be permitted to enter the Union if 
they originate from a third country  or territory or zone thereof which complies with the animal 
health requirements laid down in Article 13 3.   
EN 89  EN Article 138 
The wild ungulates  of origin of the fresh meat  
Consignments of f resh meat of wild ungulates shall only be permitted if they were obtained 
from animals which comply with the following requirements:  
(a) they were killed at a distance that exceeds 20 k ilometres  from the borde r of any third 
country  or territory or zone thereof which at that time was not listed  for the entry into 
the Union of fresh meat of the species of wild ungulates;  
(b) they were killed in an area of 20 k ilometres  radius, where, during the preceding 60 
days, there were no restrictions due to a case or outbreak of the diseases referred to in 
Part A of Annex 24 . 
Article 13 9 
The game handling establishment of origin of fresh meat of wild ungulates  
Consignments of f resh meat of wild ungulates shall only be permitted to enter the Union if 
they have  obtained in  a game handling establishment in and around which there has been no 
case or outbreak of the listed diseases referred to in Part A of Annex 24 in an area of 10 
kilometres , including where appropriate the  territory of a neighbouring country , for a period 
of 30 days  prior to the date of killing . 
Chapter 3  
Animal health requirements for fresh meat of poultry and wild 
game birds  
SECTION 1 
SPECIFIC ANIMAL HEALT H REQUIREMENTS FOR F RESH MEAT OF POULTRY  
Article 140 
The residency period of poultry  
Consignments of f resh meat of poultry shall only be permitted to enter the Union if they have  
been obtained from poultry which:  
(a) has been kept since hatching and until the date of slaughter in the third country or 
territory of origin of the fresh meat  or zone thereof;  
or 
(b) was imported as day -old chicks, breeding poultry, productive poultry or poultry 
intended for slaughter from a third country or territory or zone thereof which is listed  
for entry into the Union fo r those commodities or from a Member State and the 
import took place in accordance with animal health requirements at least as stringent  
as the relevant requirements of this Regulation.   
Article 141 
The third country  or territory of origin or zone thereof of the fresh meat of poultry  
Consignments of f resh meat of poultry shall only be permitted to enter the Union if they 
originate from a third country  or territory or zone  thereof  which complies with the following 
requirements :  
EN 90  EN (a) it has a disease surveillance programme  for highly pathogenic avian influenza in 
place for a period of at least six months prior to the date of dispatch of the 
consignment to the Union and that surveillance programme complies with the 
requirements  laid down in either:  
(i) set out in Annex 2 to this Regulation ;  
or 
(ii) relevant Chapter of the Terrestrial Animal Health Code of the World Animal 
Health Organisation (OIE ); 
(b) it is considered to be free from highly pathogenic avian influenza in accordance with 
Article 3 8; 
(c) where it carried ou t vaccination against highly pathogenic avian , the competent 
authority of the third country or territory of origin has provided guarantees that : 
(i) the vaccination programme complies with the requirements set out in Annex 
13; 
(ii) the surveillance programme  referred to in point (a) of this Article,  in addition 
to the requirements set out in Annex 2 , complies with  the requirements set out 
in Part 2 of Annex 13 ; 
(iii) it has undertaken to inform the Commission of any change to the vaccination 
plan in the third country or territory or zone thereof ; 
(d) which:  
(i) in the case of fresh meat of poultry other than ratites, it is considered to be free 
from infection with Newcastle disease virus in accordance with Article 39; 
(i) in the case of fresh meat of rati tes, is  either : 
– considered to be free from infection with Newcastle disease virus in 
accordance with Article 39; 
or  
– not considered to be free from infection with Newcastle disease virus in 
accordance with Article 39, but the competent authority of the third 
country or territory of origin has provided  guarantees  regarding  
compliance with the requirements for infection with Newcastle disease 
virus  in relation to isolation, surveillance and testing, as set out in Annex 
14; 
(e) where vaccination against infecti on with Newcastle disease virus is carried out , the 
competent authorit y of the third country or territory ha s provided guarantees that: 
(i) the vaccines used comply with the general and the specific criteria for vaccines 
against infection with Newcastle di sease virus set out in Part 1 of Annex 15 ; or 
(ii) the vaccines used comply with the general criteria for vaccines against 
infection with Newcastle disease virus set out in Part 1 of Annex 15 and the 
poultry meet the animal health requirements for poultry and hatching eggs 
originating from a third country or territory or zone thereof where vaccines 
used against infection with Newcastle disease virus do not meet the specific 
criteria set out in Part 2 of Annex 15 ;  
EN 91  EN (f) it has undertaken that following  an outbreak of highly pathogenic avian influenza or 
an outbreak of infection with Newcastle disease virus , to submit the following 
information to the Commission:  
(i) information on the disease situation within 24 hours of confirmation of any 
initial outbreak of highly pathogenic avian influenza  or infection with 
Newcastle disease virus ; 
(ii) regular updates of the disease situation;   
(g) which has undertaken to submit v irus isolates from initial outbreaks of highly 
pathogenic avian influenza and infection  with Newcastle disease virus to the 
European Union Reference Laboratory for Avian Influenza and  Newcastle disease . 
Article 142 
The establishment of origin of the poultry  
Consignments of  fresh meat of poultry shall only be permitted to enter the Union if t hey 
originate from poultry which come from an establishment:  
(a) in which and within a 10 k ilometres  radius of the establishment , including, where 
appropriate, the territory of a neighbouring country, there has been no outbreak of 
highly pathogenic avian influ enza or infection with Newcastle disease virus  during 
the period of  at least 30 days prior to  the date of slaughter ; 
(b) which, in the case of fresh meat of ratites originating in a third country or territory or 
zone thereof not free from infection with Newcas tle disease virus, complies with the 
animal health requirements for ratites, hatching eggs thereof and fresh meat of ratites 
originating in a third country or territory or zone thereof not free from infection with 
Newcastle disease virus , set out in points 3(b) and (c) of Annex 14. 
Article 143 
The poultry of origin  of the fresh meat  
1. Consignments of  fresh meat of poultry shall only be permitted to enter the Union if 
they have been obtained from poultry which  has not been vaccinated against highly 
pathogenic avian influenza  or infection with Newcastle disease virus , or they comply 
with the following requirements:   
(a) where they have been vaccinated against highly pathogenic avian influenza, 
guarantees for compliance with the minimum requirements for vaccination 
programmes and additional surveillance set out in Annex 13, have been 
provided by the third country or territory of origin;  
(b) where they have been vaccinated against infection with Newcastle disease 
virus:  
(i) guarantees have been provided b y the competent authority of the third 
country or territory of origin that the vaccines used comply with:  
– the general and the specific criteria for vaccines against infection 
with Newcastle disease virus set out in Part 1 of Annex 15 ; or 
– the general criter ia for recognised vaccines against infection with 
Newcastle disease virus set out in Part 1 of Annex 15 and the 
poultry  and hatching eggs from which the day -old chicks originated  
meet the animal health requirements in relation to vaccination,  
EN 92  EN isolation, te sting and contact with other poultry set out in Part 2 of 
Annex 15 ; 
(ii) the information set out in Part 5 of Annex 15 must  be provided for the 
consignment.  
2. Consignments  of fresh  meat of poultry which is destined to a Member State or 
territory with status free from infection with Newcastle disease virus  without 
vaccination , shall only be permitted to enter the Union if it originate s from poultry 
which has not been vaccinated against Newcastle disease with a live vaccine during 
the period of 30 days prior to the date of  slaughter.  
Article 144 
The establishment of origin for the fresh meat  of poultry  
Consignments of  fresh meat of poultry  shall only be permitted to enter the Uni on if they 
originate  from a slaughterhouse  which : 
(a) at the time of slaughter, was not under restrictions due to an outbreak of highly 
pathogenic avian influenza or infection with Newcastle disease virus or under official 
restrictions under national legislation for animal health reasons;  
(a) within a 10 k ilometre radius of  the slaughterhouse , including, where appropriate, the 
territory of a neighbouring country, there has been no outbreak of highly pathogenic 
avian influenza or infection with Newcastle disease virus during the period of  at least 
30 days prior to the date of slaughter.  
SECTION 3 
SPECIFIC ANIMAL HEALT H REQUIREMENTS FOR F RESH MEAT OF WILD GA ME 
BIRDS  
Article 145 
The third country or territory of origin or zone thereof  of the fresh meat of wild game birds  
Consignments of  fresh meat of wild game bird s shall only be permitted to enter the Union if 
they originate from a third country or territory or zone thereof  which complies with the 
following requirements : 
(a) it has a disease surveillance programme  for highly pathogenic avian influenza in 
place for a pe riod of at least six months prior to the date of dispatch of the 
consignment to the Union and that surveillance programme complies with the 
requirements  established  in either:  
(i) Annex 2  to this Regulation ;  
or 
(ii) in the relevant Chapter of the Terrestr ial Animal Health Code of the World 
Animal Health Organisation (OIE) ; 
(b) where there have been no animal health restrictions due to an outbreak of highly 
pathogenic avian influenza or infection with Newcastle disease virus during the  
period of at least 30 days prior to the time of killing.   
EN 93  EN Article 146 
The establishment of origin of the fresh meat  of wild game birds  
Consignments of  fresh meat of wild game birds shall only be permitted to enter the Uni on if 
they come from a game handling establishment:  
(a) which,  at the time of dressing, was not under restrictions due to an outbreak of highly 
pathogenic avian influenza or infection with Newcastle disease virus or under official 
restrictions for animal health reasons;  
(b) within a 10 k ilometres  radius of the game handl ing establishment , including, where 
appropriate, the territory of a neighbouring country, there has been no outbreak of 
highly pathogenic avian influenza or infection with Newcastle disease virus during 
the period of  at least the 30 days prior to  the date of reception of the carcasses . 
TITLE 3  
ANIMAL HEALTH REQUIREMENTS FOR ENTRY INTO 
THE UNION OF MEAT PRODUCTS AND CASINGS  
Article 147 
Treatment of meat products  
Consignments of m eat products shall only be permitted to enter the Union if they  have been 
treated in accordance with Article 121 as required in Articles 14 8 or 14 9. 
Article 148 
Meat products not subject to a risk mitigating treatment  
Consignments of  meat products shall only be permitted to enter the Union if they have not 
undergone a risk mitigating treatment in accordance with Annex 26 where :  
(a) the third country or territory of origin or zone thereof is listed  for the entry into the 
Union of fresh meat of the relevant species, and specific conditions  in accordance 
with Chapter 1 an d 2 of Title 1, Part IV, are not required for the entry into the Union 
of such fresh meat;  
(b) the fresh meat used for the processing of the meat product complied with all the 
requirements for the entry into the Union of fresh meat and therefore w as eligible for 
the entry into the Union  and originat ed from ;  
(i) the third country or territory or zone thereof  where the meat product was 
processed ;  
(ii) a listed third country or territory or zone thereof which is listed  for the entry 
into the Union of fresh meat of the relevant species;  
(iii) a Member State . 
Article 14 9 
Meat products subject to a risk mitigating treatment  
1. Consignments of meat products that do not fulfil the requirements provided for in  
Article 14 8, shall only be permitted to enter the Union if they have undergo ne at least 
the risk mitigating treatment  set out in Annex 26 specifically assigned by the Union 
in the list to the third country or territory or zone thereof  of origin of the meat  
EN 94  EN product in accordance with Article 121 , where  the fresh meat used for processing of 
the meat products originates from:  
(a) the third country or territory or zone thereof where the meat product has been 
processed;  
(b) a listed third country or territory or zone thereof authorised for entry into the 
Union of fresh meat of the relevant species;  
(c) a Member State .  
2. Consignments of m eat products shall only be permitted to enter the Union if they 
have undergone at least the risk mitigating  treatment ‘B’, in accordance with  Annex 
26, where the fresh meat used for the processing of the meat products originates from 
a third count ry or territory or zone thereof:  
(a) other than  the third country or territory or zone thereof in which the meat 
product is obtained ;  
(b) which is also listed for the entry into the Union of meat products of the relevant 
species, subject to a risk mitigating treatment specific ally assigned  by the 
Union in the list, to that third country or territory or zone thereof  and to the 
relevant species , in accordance wi th Article 121 . 
3. Consignments of m eat products processed from  fresh meat of poultry shall only be 
permitted to enter the Union if they have undergone at least the risk mitigating  
treatment ‘D’, in accordance with Annex 26, where the fresh meat used for the 
processing of the meat products originates from a third country or territory or zone 
thereof:  
(a) listed  for the entry into the Union of fresh meat of poultry;  
(b) in which there has been a case or an outbreak of highly pathogenic avian 
influenza or in fection with Newcastle disease virus.  
4. Consignments of  meat products which  have been processed from fresh meat of more 
than one species of animal  from the third country or territory or zone thereof where 
the meat product was processed , shall only be perm itted to enter the Union if they  
comply with the following requirements : 
(a) the meat products must have undergone the most severe of the risk mitigating 
treatments assigned in the list to the third country or territory or zone thereof, 
in accordance with Article 121, for the different species of animals of origin , 
where the fresh meat is mixed before the final processing of the meat product 
takes place;  or 
(b) the meat products must have un dergone the risk mitigating treatment assigned  
in the list  to the third country or territory or zone thereof, in accordance with 
Article 121, for each different species of animals of origin , where the mixing of 
the meat products have taken place after proc essing of each ingredient of the 
meat product.  
5. Consignments of meat products which have been processed from  fresh meat of more 
than one species of animal originating from a third  country or territory or zone 
thereof other than the third country or terri tory or zone thereof  where the meat 
product has been processed, shall only be permitted to enter the Union if they have  
undergo ne a risk mitigating treatment in accordance with paragraphs 1 or 2.   
EN 95  EN Article 150 
The establishment of origin of the animals from which the fresh meat was obtained  
Consignments of meat products shall only be permitted to enter the Union if they that have 
been processed from fresh meat which originate from animals coming from an establishment, 
or, in the case of wild animals, from a place in and around which, in an area of 10 k ilometres  
radius, including where appropriate the territory of a neighbouring country, there has been no 
case or outbreak of a listed disease, relevant for the species of origin of the meat products in 
accordanc e with Annex 1 , during the period of 30 days  prior to the date of dispatch of the 
consignment to the Union . 
Article 151 
The entry into Member States with status free from infection with Newcastle disease virus  
without vaccination  
Consignments of meat products of poultry intended for a Member State or territory thereof 
with a status free from  infection with Newcastle disease virus  without vaccination  shall only 
be permitted to enter into the Union if they have obtained from poultry which ha ve not be en 
vaccinated with a live vaccine against infection with Newcastle disease virus, during the 
period of 30 days prior to the date of slaughter.  
Article 15 2 
Specific requirements for the entry into the Union of casings  
Consignments of casings  shall only be p ermitted to enter the Union if they have  undergo ne 
the following risk mitigating treatments set out in Part 2 of Annex 26:  
(a) treatments ‘Casing 1’ or ’ Casing 2’, where the bladders and intestines used for the 
processing of the casings originate from  animals of the species Bos taurus, Ovis 
aries, Capra hircus  or kept Sus scrofa ;  
(b) treatments ‘Casing 3’, ‘Casing 4’ or ‘Casing 5’ where the bladders and intestines 
used for the processing of the casings originate from  animals of species other than  
those referred to in point (a) . 
TITLE  4 
ANIMAL  HEALTH  REQUIREMENTS  FOR  THE  ENTRY  INTO  
THE  UNION  OF MILK,  DAIRY  PRODUCTS,  COLOSTRUM  AND  
COLOSTRUM -BASED  PRODUCTS  
Chapter 1  
Specific animal health requirements for raw milk , colostrum  and 
colostrum based products  
Article 153 
The country of origin of the raw milk  and colostrum   
Consignments of r aw milk , colostrum and colostrum based products shall only be permitted to 
enter  the Union if they  originate from a third country  or territory or zone thereof which has 
been free from:   
EN 96  EN (a) foot and mouth disease for a period of at least 12 months  prior to the date of  milking , 
and during that period of time no vaccination against th at disease has been carried 
out;  
(b) rinderpest for a period of 12 months  prior to the date of  milking . 
Article 154 
The animals of origin  of the raw milk  and colostrum   
Consignments of r aw milk , colostrum  and colostrum based products shall only be permitted to 
enter the Union if they were obtained from animals of the species Bos taurus, Ovis aries, 
Capra hircus, Bubalus bubalis  or Camelus dromedarius  that complied  with a residency 
period of at least 3 months , prior to the date of milking , in the third country , territory or zone  
thereof of milking .  
Chapter 2  
Specific animal health requirements for dairy products  
Article 155 
Treatment of dairy products  
Consignments of d airy products shall only be permitted to enter the Union if they  have been 
treated as required  in Article 156 or 15 7. 
Article 156 
Dairy produc ts not subject to a risk mitigating treatment  
Consignments of d airy products which have not undergone a risk mitigating treatment of 
those set out in Annex 27  shall only be permitted to enter the Union if they comply with 
following requirements : 
(a) they were obtained from animals of the species Bos taurus, Ovis aries, Capra hircus, 
Bubalus bubalis  and Camelus dromedarius;  
(b) the third country  or territory of origin or zone  thereof  is listed  for the entry into the 
union of raw milk and colostrum of the r elevant species; and  
(c) the raw milk used for the processing of the dairy products complied with all the 
requirements for the entry into the Union of raw milk  laid down in this Regulation , 
and therefore  was eligible for the entry into the Union  and it originate s from  one of 
the following : 
(i) the listed third country or territory or zone where the dairy products were 
processed;  
(ii) a third country or territory or zone thereof other than listed third country or 
territory or zone thereof where the dair y products were processed and which is 
authorised for the entry into the Union of raw milk ; or  
(iii) a Member State.   
EN 97  EN Article 157 
Dairy products subject to a risk mitigating treatment  
1. Consignments of d airy products shall only be permitted to enter the Union if they  
have undergone  at least one of the risk mitigating treatments provided for in column 
A of Annex 27 , where:  
(a) they were processed from milk  obtained from the species Bos Taurus, Ovis 
aries , Capra hircus, Bubalus bubalis  or Camelus dromedariu s;  
(b) the third country  or territory of origin or zone  thereof  has not been free from 
foot and mouth disease for the period of 12 months preceding the date of 
dispatch of the consignment to the Union or where in the same period 
vaccination against foot a nd mouth disease has been practised.  
2. Consignments of d airy products shall only be permitted to enter the Union if they 
have undergone at least one of the risk mitigating treatments provided for in  column 
B of Annex 27 where they were processed from milk obtained  from species of 
animals other than those referred to in  paragraph 1(a) .  
3. Consignments  of dairy products that have been processed from raw milk  or from 
dairy products obtained from more than one species of animal shall only be permitted 
to enter the Union  if they  have undergone  either : 
(a) at least the most severe of the risk mitigating treatments  assigned in the list to 
the different species of animals of origin, where the mix ing of raw milk  or 
dairy products takes place before the final pr ocessing of the product;  or 
(b) the risk mitigating treatment assigned by the Union in the list to each species of 
animals of origin, where the mixing of the products takes place  after processing 
of each ingredient of the dairy product.  
TITLE  5 
ANIMAL  HEALTH  REQUIREMENTS  FOR  ENTRY  INTO  THE  
UNION  OF EGGS  AND  EGG  PRODUCTS  
Chapter 1  
Specific animal health requirements for eggs  
Article 158 
The third country or territory of origin or zone thereof of the eggs  
Consignments of eggs shall only be permitted to en ter the Union if they originate from a third 
country or territory or zone thereof which applies a disease surveillance programme for  highly 
pathogenic  avian influenza that complies with the requirements  lestablished in either:  
(a) Annex 2  to this Regulatio n;  
or 
(b) the relevant Chapter of the Terrestrial Animal Health Code of the World Animal 
Health Organisation (OIE ).  
EN 98  EN Article 159 
The establishment of origin of the eggs  
Consignments of  eggs shall only be permitted to enter the Union if they  originate from an 
establishment  that complies with the following requirements : 
(a) during  the period of 30 days prior to the date of collection of the eggs and until the 
date of issue of the certificate for the entry into the Union, no outbreak of highly 
pathogenic avian  influenza or infection with Newcastle disease virus occurred; and  
(b) within a 10 km radius of the establishment , including, where appropriate, the 
territory of a neighbouring country there was no outbreak of highly pathogenic avian 
influenza for a period  of at least 30 days prior to the date of collection of eggs  and 
until the date of issue of the certificate for the entry into the Union . 
Chapter 2  
Specific animal health requirements for egg products  
Article 160 
The third country or territory of origin or  zone thereof of the egg products  
Consignments of  egg products shall only be permitted to enter the Union if they  originate 
from a third country or territory or zone thereof which applies a disease surveillance 
programme for  highly pathogenic  avian influen za that complies with the requirements  
established  in either:  
(a) Annex 2  to this Regulation ;  
or 
(b) relevant Chapter of the Terrestrial Animal Health Code of the World Animal Health 
Organisation (OIE ). 
Article 161 
The establishment of origin of the eggs  
Consignments of  egg products shall only be permitted to enter the Union if they have been  
processed  from eggs that originated in an establishment:  
(a) in which, during  the period of 30 days prior to the date of collection of the eggs, no 
outbreak of highly  pathogenic avian influenza and infection with Newcastle disease 
virus has occurred;  
(b) within a 10 km radius of the establishment , including, where appropriate, the 
territory of a neighbouring country , there has either been : 
(i) no outbreak of highly pat hogenic avian influenza for a period of at least 30 
days prior to the date of collection of eggs;  or 
(ii) an outbreak of highly pathogenic avian influenza within the period of 30 days 
prior to the date of collection of eggs  and the egg product has undergon e one of 
the risk mitigating treatments for egg products set out in Part 1 of Annex 28 . 
(c) within a 10 km radius of the establishments , including, where appropriate, the 
territory of a neighbouring country , there has either been : 
(i) no outbreak of infect ion with Newcastle disease virus for a period of at least 30 
days prior to the date of collection of eggs;  or  
EN 99  EN (ii) an outbreak of infection with Newcastle disease virus within the period of 30 
days prior to the date of collection of eggs and the egg produc t, has undergone 
one of the risk mitigating treatments for egg products set out in Part 2 of Annex 
28. 
TITLE  6 
ANIMAL  HEALTH  REQUIREMENTS  FOR  ENTRY  INTO  THE  
UNION  OF PROCESSED  PRODUCTS  OF ANIMAL  ORIGIN  
CONTAINED  IN COMPOSITE  PRODUCTS  
Article 162 
Composite products containing meat products and non -shelf stable composite products 
containing dairy and/or egg products  
1. Consignments  of the following composite products shall only be permitted to enter 
the Union if  they come from a third country or territory or zone thereof listed for the 
entry into the Union of the specific product of animal origin contained in those 
composite products:  
(a) composite products containing meat products;  
(b) composite products containing dairy products or egg products which have not 
been processed  to become shelf stable.   
2. Consignments of  composite products shall only be permitted to enter the Union if the 
processed products of animal origin contained in the composite products referred to 
in paragraph 1 :  
(a) comply with :  
(i) the relevant general animal health requirements for the entry into the 
Union of products of animal origin laid down in Part 1 of this Regulation;  
(ii) the animal health requirement s for the entry into the Union of the specific 
product of animal origin, as laid down in Titles 1 to 5 of this Part . 
(b) they have been obtained  either :  
(i) in the same listed third country or territory of origin or zone thereof of 
the composite product;  
(ii) in the Union; or 
(iii) in a third country or territory  or zone  thereof  listed for the  entry  into the 
Union of those products with out undergoing  a specific risk mitigating 
treatment , in accordance with Articles 14 8 and 15 6, if the third country  
or territory or zone  thereof where the composite product is produced is 
also listed for the entry into  the Union of those products without the 
obligation to apply a specific risk mitigating treatment.  
Article 163 
Shelf stable composite products containing dairy and/or egg products  
Consignments of  composite products containing only d airy or egg products  shall only be 
permitted to enter the Union if the dairy products and the egg  products  contained in the 
composite products have been treated to become shelf stable at ambient temperature and they :   
EN 100  EN (a) have been subjected to a treatment , at least equivalent to the following treatments:  
(i) risk mitigating treatments for dairy products as set out in column B in Annex 
27; 
(ii) risk mitigating treatments for egg products set out in in Annex 28 ; 
(b) by way of derogation of point 1(c)(i) of A rticle 3, are accompanied by a declaration 
of the operator of the third country or territory of origin of the composi te products, 
attesting that  the dairy products and egg products contained  in the composite 
products have undergone at least the risk mitiga ting treatment provided for in point  
(a).  
TITLE  7 
SPECIAL  RULES  FOR  THE  ENTRY  INTO  THE  UNION  OF 
PRODUCTS  OF ANIMAL  ORIGIN  INTENDED  FOR  PERSONAL  
USE  
Article 164 
Derogation from animal health requirements and additional requirements for the entry of 
infant milk, infant food and special foods intended for personal use  
By way of derogation from the requirements laid down in Articles  3 to 10 of Part I and 
Articles  120 to 16 3, consignments of powdered infant milk, infant food and special foods  
required for medical reasons , containing products of animal origin  which do not comply with 
those requirements shall be permitted to enter the Union  if they :  
(a) are intended for  personal use;  
(b) do not exceed  a combined quantity of 2 kilogramme  per person;  
(c) do not require refrigeration before opening;  
(d) are packaged proprietary brand products for direct sale to the final consumer;  
(e) maintain the packaging unbroken, unles s in current use.  
Article 165 
Deroga tion from animal health requirements for products of animal origin intended for 
personal use originating from certain third countries or territories or zones thereof  
1. By way of derogation from requirements laid down in Articles 3 to 10 of Part I , 
except point (a)(i) of Article 3, and Articles 120 to 16 3, consignments of  products of 
animal origin which  do not comply with those requirements  shall be permitted to 
enter the Union  if they are intended for personal use and originate from neighbouring 
third countries or territories listed for the entry into the Union of specific quantities 
of products of animal origin intended for personal use based on  specific agreements 
with the Union on trade in agricultural products . 
2. The combined specific quantity  allowed to enter the Union accompanying a person 
shall not exceed the maximum specified for the third country or territory  in the list .  
PART V  
Animal health requirements for the entry into the Union as 
referred to in Articles 3 and 5 of aquatic animals of listed species  
EN 101  EN and their products of animal origin , and for their movement and 
handling after the entry  
TITLE  1 
GENERAL  ANIMAL  HEALTH  REQUIREMENTS  FOR  THE 
ENTRY  INTO  THE  UNION  OF THE AQUATIC  ANIMALS  
REFERRED TO IN ARTICLE 1(6) AND  THEIR  PRODUCTS   
Article 166 
Inspection of aquatic animals prior to dispatch  
Consignments of a quatic animals shall only be permitted to en ter the Union if they have been 
subjected to a clinical inspection by an official veterinarian in the exporting third country or 
territory, zone or compartment thereof within a period of 72 hours prior to the time of loading 
for dispatch of the consignment  to the Union for the purpose of detection of symptoms of 
disease  and abnormal mortalities.  
Article 167 
Dispatch to the Union of aquatic animals  including  aquatic animals intended for human 
consumption and products of animal origin from aquatic animals  other than live aquatic 
animals   
Consignments of aquatic animals including aquatic animals intended for human consumption 
and products of animal origin  from aquatic animals other than live aquatic animals,  shall only 
be permitted to enter the Union if they comply with the following requirements:  
(a) they were  dispatched directly from their establishment of origin to the Union ; 
(b) they were not unloaded, moved to another means of transport or unloaded from their 
container when transported by air, sea, rail way or by road, and the water in which 
they are transported was not changed, in a third country or territory, zone or 
compartment which is not listed  for the entry of the particular species and  category 
of aquatic animals into the Union ;  
(c) they have not have been transported under conditions that have jeopardise d their 
health status, in particular:  
(i) where relevant, they must have been loaded and transported in water which did 
not alter their health status;  
(ii) the means of transport and the containers must have been constructed in such a 
way that the health status of the aquatic animals was not jeopardised during the 
transport;  
(iii) the transport container or well boat must have been cleaned and disinfected, in 
accordance with a protocol and with products approved by the competent 
authority of the third country or territory of origin, prior to loading  for dispatch 
to the Union , which ensure that the health status of the aquatic animals is not 
jeopardised during transport;   
(d) from the time of loading at the establishment of origin until the time of arrival to the 
Union , they must not have been transported in the same water or container  or well -
boat together with aquatic animals which were of a lower health statu s or which were 
not intended for entry into the Union;   
EN 102  EN (e) where a water  exchange is necessary  in a third country, territory, zone or 
compartment which is listed for entry of the particular species and category of 
aquatic animals into the Union , it must not have jeopardise d the health status of the 
animals being transported  and it must have only occur red : 
(i) in the case of transport on land, at water exchange points approved by the 
competent authority  of the third country or territory where the water ex change 
takes place ;  
(ii) in the case of transport by well-boat, at a distance which is at least 10 
kilometres  from any aquaculture establishments which are located en -route 
from the place of origin to the place of destination  in the Union . 
Article 168 
Transport by vessel  of aquatic animals  
When dispatch to the Union of consignments of aquatic animals including those  intended for 
human consumption, includes transport by vessel  or well -boat even for part of the journey, 
those consignments of aquatic animals transported in accordance with Article 167 shall only 
be permitted to enter the Union if they are  accompanied by a declaration, attached to the 
animal health certificate and signed by the master of the vessel  on the day of arrival of the 
vessel at its port of destination, providing the following information:  
(a) the port of departure in the third country  or territory;  
(b) the port of arrival in the Union;  
(c) the ports of call, in the case the vessel called at ports outside the third country or  
territory of origin or zone  thereof ;  
(d) confirmation of compliance of the consignment of aquatic animals with the relevant 
requirements set out in Article 167 throughout  the journey  from the port of depart ure 
in the third country or territory to the port of arrival in the Union . 
Article 169 
Specific transport and labelling requirements  
1. Consignments of a quatic animals including those intended for human consumption 
shall only be permitted to enter the Union if they are identified by a legible label on 
the exterior of the container, or when transported by well -boat,  an entry in the 
vessel 's manifest  which refers to the animal health certificate  that has  been issued for 
that consignment.  
2. The legible label referred to in  paragraph 1 shall also contain at least the following 
information:  
(a) the number of boxes in the consignment;  
(b) the name of the species present in each box;  
(c) the number of animals in each box for each of the species present;  
(d) the purpose for whic h they are intended ; 
3. Products of animal origin from aquatic animals  other than live aquatic animals,  
intended for entry into the Union shall comply with the following requirements  :   
EN 103  EN (a) they must be identified by a legible label on the exterior of the container, or 
when transported by sea, an entry in the vessel 's manifest, which refers to the 
certificate that has been issued for that consignment;  
(b) the legible label referred to in point (a)  must  also contain the following 
statement s, as relevant:  
(i) fish intended for human consumption in the European Union;  
(ii) bi-valve molluscs intended for human consumption in the European 
Union;  
(iii) crustaceans intended for human consumption in the Europea n Union.  
Article 170 
Animal hea lth status of the third country or territory of origin or zone or compartment  thereof   
Consignments of aquatic animals including those intended for human consumption and 
products of animal origin  from aquatic animals other than live aquatic animals  shall only be 
permitted to enter the Union if they come from a third country or territory or  zone or 
compartment thereof which complies with the following requirements:  
(a) it must be free from the following listed diseases:  
(i) category A diseases and category B diseases of aquatic animals;  
(ii) relevant category C diseases when the aquatic animals or products of animal 
origin are destined for Member States, zones or compartments which have 
disease -free status or an approved eradication programme  for the specific 
diseases;   
(iii) category C diseases in all cases when the aquatic animals are int ended for 
release into the wild ;  
(iv) where Member States of destination have taken national measures referred  to 
in Article 176 of this  Regulation , aquatic animals of the species listed in Annex 
29 must also originate from third countries, territories, zones or compartments 
that are free from the diseases  referred to in that Annex ;  
(b) all the entries of aquatic animals of listed species into the third country or territory, 
zone or compartment exporting to the Union must originate from a different third 
country or territory or zone or compartment thereof which is free from the diseases 
referred to in point (a);  
(c) vaccination of aquatic animals of listed species against category A  diseases , category 
B or where relevant category C diseases, has not been carried out  in the third country 
or territory of origin . 
Article 171 
Vector species  
Aquatic animals listed in column 4 of the Annex to Commission Implementing Regulation 
(EU) 2018/1882 shall only be regarded as vectors of those diseases under the conditions set 
out in Annex 30 .   
EN 104  EN Article 17 2 
Derogations for certain categories of aquatic an imals of listed species  
By way of derogation  from Article  170, the requirements laid down in that Article shall not 
apply to the following categories of aquatic animals:  
(a) aquatic animals which are destined for a disease control aquatic food establishmen t 
where they are to be processed for human consumption ; 
(b) aquatic animals intended for research purposes which are destined for confined 
establishments which have been approved for that purpose by the competent 
authority of the Member State of destination ;  
(c) wild aquatic animals other than those referred to in point ( b) of this Article provided 
that they have been subject to quarantine in a quarantine establishment which has 
been approved for that purpose by the competent authority  in: 
(i) the third country of origin; or 
(ii) the Union ; 
(d) molluscs or crustacea which are packed and labelled for human consumption in 
accordance with Regulation (EC) No. 853/2004 and which  are no longer able to 
survive as living animals if returned to the aquatic  environment;  
(e) molluscs  or crustacea  which are packaged and labelled for human consumption in 
accordance with Regulation (EC) No. 853/2004 and which are intended for further 
processing  without temporary storage at the place of processing;  
(f) live bival ve molluscs or crustacea which are intended for human consumption 
without further  processing, provided that they are packaged for retail  sale in 
compliance with the provisions of  Regulation (EC) No 853/2004 .  
Article 17 3 
Derogations for certain products of  animal origin from aquatic animals  other than live 
aquatic animals   
By way of derogation  from Article  170, the requirements laid down in that Article shall not 
apply to the following products of animal origin from aquatic animals  other than live aquatic 
animals : 
(a) products of animal origin from aquatic animals other than live aquatic animals which 
are destined for a disease control aquatic food establishment where they aer to be 
processed fopr human consumption;  
(b) fish intende d for  human consumption which were slaughtered and eviscerated before 
dispatch to the Union . 
Article 17 4 
Handling of aquatic animals and products of animal origin from aquatic animals after entry 
into the Union  
1. After their entry into the Union, consignm ents of aquatic animals and products of 
animal origin from aquatic animals other than live aquatic animals must be: 
(a) transported directly to the place of destination  in the Union ; 
(b) hand led appropriately to ensure that natural waters are not contaminated.   
EN 105  EN 2. Aquatic animals and products of animal origin from aquatic animals other than live 
aquatic animals which have entered the Union shall not be released by the operator 
or otherwise immersed in natural waters  within the Union, unless authoris ed by the 
competent authority of the Member State in which that release or immersion takes 
place.   
3. The competent authority of the Member State may only grant the authorisation 
referred to in paragraph 2 of this Article where the release or immersion in natural 
waters does not jeopardise the health status of the aquatic animals at the place of 
release and in all cases, release into the wild shall comply with Article  170(a)(iii).  
4. Transport water from consignments of aquatic animals and products of anima l origin 
from aquatic animals  other than live aquatic animals  shall be handled appropriately 
by the operator to prevent contamination of natural waters in the Union.  
TITLE 2 
ANIMAL HEALTH REQUIR EMENTS TO LIMIT THE IMPACT OF CERTAIN 
NON-LISTED DISEASES  
Article 17 5 
Additional animal health requirements to limit the impact of non -listed diseases for which 
Member States have national measures  
1. The competent authority of Member States that have taken national measures against 
diseases other than listed dis eases as provided for in Article 226 of Regulation (EU) 
2016/429, shall take measures to prevent the introduction of th ose non-listed diseases 
through the application of additional animal health requirements for the entry of the 
aquatic animals and product s of animal origin from aquatic animals into those 
Member States, zones or compartments of the Union.  
2. The competent authority referred to in paragraph 1 shall only permit the entry  into 
their Member State of consignments of a quatic animals of species which are 
susceptible to the diseases referred to in paragraph 1  when vaccination against those 
diseases has not been carried out in the third country or territory of origin . 
3. The competent authority referred to in paragraph 1 shall ensure that a quatic animals 
of the species referred to in paragraph 2 which are introduced into a third country or 
territory of origin or zone or compartment thereof shall originate from another third 
country, zone or compartment which is also free of the relevant dise ase.  
4. The derogations provided for in Articles 172 and 173 shall  apply to those aquatic 
animals and products of animal origin from aquatic animals which are referred to in 
paragraph 2 and which are destined for Member States which have national measures  
against the diseases referred to in paragraph 1  of this Article . 
5. Handling after entry into the Union of the aquatic animals referred to in paragraph 2 
of this Article and products from those animals, shall comply with the conditions set 
out in Article  174. 
Part VI  
Special rules for the entry of certain commodities  as referred to in 
Articles 3 and 5 for which the Union is not the final destination  
EN 106  EN and for the entry of certain commodities  originating from and 
returning to the Union   
Article 176 
Requireme nts for transit through the Union  
1. Consignments of animals , germinal products  and products of animal origin falling 
within the scope of this Regulation not originating from but transiting through the 
Union and intended for a destination outside the Union  shall only be permitted to 
transit through the Union if , either:   
(a) they comply with all the relevant requirements for  the entry into the Union of 
the particular species and category of animal s, germinal product s or product s of 
animal origin in question laid down in Parts I to V ; or  
(b) they fall within the scope of  specific conditions set out in the list, specifically 
assigned to the listed  third country or territory or zone of origin  and to the 
particular species and category of animals, germinal products and products of 
animal origin , to mitigate any potential animal health risk involved in such 
movements .  
2. Consignments of animals , germinal products and products of animal origin falling 
within the scope of this Regulation originating and returning to the Union after 
transiting through a third country  or territory or zone thereof  shall only be permitted  
to re-enter the Union if they comply with all the relevant requirements for the 
particular category  of animal s, germinal product s or product s of animal or igin in 
question for the entry into the Union laid down in Parts I to V, unless  they fall within 
the scope of either : 
(a) the additional requirements laid down in Articles 177 to 182; or 
(b) specific conditions set out in the list, specifically assigned to  the listed third 
country or territory or zone of transit  and to the particular species and category 
of animals, germinal products and products of animal origin , to mitigate any 
potential animal health risk involved in such movements . 
3. The specific condi tions referred to in paragraph 1 and paragraph 2 (b) shall be 
assigned to the third country or territory of or zone thereof based on a risk 
assessment and taking into account the following:  
(a)  the criteria laid down in Article 230 of Regulation (EU) 2016/429;  
(b)  the particular species and category of animals, germinal products and products 
of animal origin intended for transit and the related animal health risks;  
(c)  geographical constrains;  
(d)  established trade routes;  
(e)  other relevant factors.   
EN 107  EN Article  177 
Addition al requirements for the entry of horses originating from, and returning to  the Union 
after temporary export to a third country  or territory or zone  thereof  to participate in 
competitions, races or cultural events  
1. Consignments of  registered h orses  tempo rarily exported from a Member State to 
third countries  or territories or zones thereof listed  for the entry of equine animals 
into the Union shall be permitted  to enter the Union provided they  comply  with the 
following additional requirements:  
(a) they have been outside the Union for a period not exceeding 90 days and 
specified for the different purposes by the Commission;  
(b) they have been kept in isolation in the third country or territory or zone thereof 
except during races, competitions or cultural  events, and the related  activities 
(including  training, warm -up and presentation ); 
(c) they have been kept only in third countries or territories or zones thereof 
belonging to the same sanitary group to which the third country or territory of 
dispatch to the Union is assigned, in accordance with the specific requirements 
of Part B of Annex 11, and they were moved into the third country or territory 
or directly into the zone of dispatch under conditions at least as strict as if they 
were moved directly to the U nion.  
2. By way of derogation from paragraph 1 (c), the entry into the Union of registered 
horses after temporary export to third countries or territories  or zones thereof  
belonging to more than one sanitary group shall be authorised for registered horses 
which have participated exclusively in specified high level competitions or races.  
Article 178 
Speci al requirements for the entry of ungulates , poultry and aquatic animals originating from, 
and returning to the Union following a refusal of entry by a third country  
1. Consignments of ungulates , poultry and aquatic animals originating from and 
returning to the Union following a refusal of entry by the competent authority of a 
third country or territory shall only be permitted to re -enter the Union  if the 
follo wing requirements are fulfilled:  
(a) the refusing third country or territory is a third country or territory or zone 
thereof listed for the entry into the Union of the species and category of 
animal s which are returning;  
(b) the animals referred to in point (a) did not transit through a third country or 
territory  or zone thereof  other than those referred to in point (a) ; 
(c) the animals are accompanied by  the following documents : 
(i) the original animal health certificate issued b y the competent authority of 
the Member State, or its electronic equivalents submitted in IMSOC, or 
an authenticated copy of the official animal health certificate provided by 
the competent authority of the Member State of origin;  
(ii) one of the following :  
– an official declaration of the competent authority or other public 
authority of the third country or territory, indicating the reason for  
EN 108  EN the refusal and if applicable, confirming that the requirements of 
point (d) have been complied with;  or 
– in the case of sealed consignments with an intact original seal, a 
declaration by the operator responsible for the consignment 
confirming that transport has taken place in accordance with point 
d(ii) and where required point d(iii).  
(iii) a declaration from the c ompetent authority of the Member State of origin 
that it agrees to accept  the consignment  and indicating the place of 
destination for its return . 
(d) where they have been unloaded  in the third country or territory  or zone thereof , 
the competent authority o f the third country or territory shall certify the 
following:  
(i) it authorised and supervised the unloading of the animals directly to 
facilities suitable for their isolation and temporary handling within the 
premises of the border control post of the thi rd country or territory;  
(ii) effective measures were  put in place to avoid direct and indirect contact 
between the animals of the consignment and any other animals;  
(iii) where necessary, effective protection from vectors of relevant animal 
diseases were provided for.  
2. The transport to and arrival at the place of the destination of the consignment shall be 
monitored in accordance with Article 2 and 3 of Commission Delegated Regulation 
(EU) …/… reference to SANTE/7146/2018 . 
Article 179 
Speci al requirements for the entry of animals other than ungulates , poultry and aquatic 
animals originating from, and returning to the Union following a refusal of entry by a third 
country  
1. Consignments of animals other than ungulates , poultry  and aquatic animal s 
originating from and returning to the Union following a refusal of entry by the 
competent authority of a third country or territory shall only be permitted to re -enter 
the Union if the animals are accompanied by the following documents:  
(a) the original animal health certificate issued by the competent authority of the 
Member State  of origin , or its electronic equivalents submitted in IMSOC, or 
an authenticated copy of the official animal health certificate provided by the 
competent authority of the Membe r State of origin;  
(b) one of the following :  
(i) an official declaration of the competent authority or other public 
authority of the third country or territory, indicating the reason for 
refusal; or 
(ii) in the case of sealed consignments or unopened transport boxes, a 
declaration by the operator responsible for the consignment indicating the 
reason for refusal.  
(c) a declaration from the competent authority of the Member State of origin that it 
agree s to accept  the consignment  and indicating the place of destination for its 
return .  
EN 109  EN 2. The transport to and arrival at the place of the destination of the consignment shall be 
monitored in accordance with Article 2 and 3 of Commission Delegated Regulation 
(EU) …/…  reference to SANTE/7146/2018 . 
Article 180 
Special requirements for the entry of germinal products and packaged products of animal 
origin, originating from, and returning to the Union following a refusal of entry by a third 
country or territory  
1. Consign ments of germinal products and products of animal origin which are 
packaged, originating from and returning to the Union following a refusal of entry by 
the competent authority of a third country or territory shall only be permitted to re -
enter the Union if the following requirements are fulfilled:  
(a) if the germinal products remain in the original container and t he packaging of 
the products of animal origin is intact;  
(b) the germinal products and the products of animal origin are accompanied  by: 
(i) the original animal health certificate issued by the competent authority of 
the Member State of the place of origin , or its electronic equivalent 
submitted in IMSOC, or an authenticated copy of the official animal 
health certificate provided by the compet ent authority of the Member 
State of origin;  
(ii) one of the following documents indicating the reason for refusal and if 
applicable the place and date of unloading, storage and re -loading in the 
third country or territory thereof and confirming that the r equirements of 
point (c) have been complied with:  
– a declaration of the competent authority or other public authority of 
the third country or territory;  or 
– in the case of containers with an intact original seal, a declaration 
by the operator responsible for  the consignment;  
(iii) a declaration from the competent authority of a Member State that it 
agrees to accept the consignment  and indicating the place of destination 
for its return;  
(c) where the germinal products  or products of animal origin referred to i n points 
(a) and (b)  have been unloaded  in the third country or territory thereof , the 
competent authority of the third country or territory shall certify the following:  
(i) the germinal products or products of animal origin did not undergo any 
other handling except unloading, storage and re -loading;  
(ii) effective measures were put in place to avoid the contamination of the 
packaging of the germinal products or products of animal origin with 
pathogens of listed diseases during the unloading, storage a nd re -loading;  
2. The transport to and arrival at the place of the destination of the consignment shall be 
monitored in accordance with Article 2 and 3 of Commission Delegated Regulation 
(EU) …/…  reference to SANTE/7146/2018 . 
Article 181 
Special require ments for the entry of unpackaged or in bulk products of animal origin,  
EN 110  EN originating from, and returning to the Union following a refusal of entry by a listed third 
country  
1. Consignments of unpackaged or in bulk  products of animal origin originating from 
and returning to the Union following a refusal  of entry by the competent authority of 
a listed third country or territory shall only be permitted to re -enter the Union if the 
following requirements are fulfilled : 
(a) the refusing country is a listed countr y for the particular species and category 
of products of animal origin which  are being returned to the Union ; 
(b) the products of animal origin are accompanied by:  
(i) the original animal health certificate issued by the competent authority of 
the Member State  of origin , or its electronic equivalents submitted in 
IMSOC, or an authenticated copy of the official certificate provided by 
the competent authority of the Member State of origin;  
(ii) one of the following:   
– an official declaration of the competent authority or other public 
authority of the third country or territory, indicating the reason for 
refusal and confirming that the seal on the vehicle or container of 
the consignment was only opened for offic ial purpose s and the 
products were handled only to  the smallest extent necessary for 
those and in particular without unloading them and the vehicle or 
container was immediately re -sealed after wards ; or 
– in the case of sealed consignments, a declaration by the operator 
responsible for the consignment indica ting the reason for refusal;  
(iii) a declaration from the competent authority of a Member State  that it 
agree s to accept the consignment  and indicating the place of destination 
for its return . 
2. The transport to and arrival at the place of the destination of the consignment shall be 
monitored in accordance with Article 2 and 3 of Commission Delegated Regulation 
(EU) …/…  reference to SANTE/7146/2018 . 
Article 182 
 Special requirements for the entr y of unpackaged or in bulk products of animal origin, 
originating from, and returning to, the Union following a refusal of entry by a non -listed third 
country  
1. Consignments  of unpackaged or in bulk products of animal origin originating from 
and returning to the Union following a refusal of entry by the competent authority of 
a third country or territory which is not listed for the entry into the Union of the 
particular specie s and category  of products of animal origin which are being 
returned , shall only be permitted to re -enter the Union if  the following requirements 
are fulfilled:  
(a) the consignment is sealed with an intact original seal;  
(b) the products of animal origin are accompanied by:  
(i) the original animal health certificate issued by the competent authority of 
the Member State  of origin , or its electronic equivalents submitted in  
EN 111  EN IMSOC, or an authenticated copy of the official animal health certificate 
provided by  the competent authority of the Member State of origin;  
(ii) one of the following :  
– an official declaration of the competent authority or other public 
authority of the third country or territory, indicating the reason for 
refusal;  or 
– a declaration by the operator responsible for the consignment 
indicating the reason for refusal;  
(iii) a declaration from the competent authority of a Member State that they 
agree to accept the consignment  and indicating the place of destination 
for its return . 
2. The transpor t to and arrival at the place of the destination of the consignment shall be 
monitored in accordance with Article 2 and 3 of Commission Delegated Regulation 
(EU) …/…  reference to SANTE/7146/2018 . 
Part VII  
Transitional and final provisions  
Article 183 
Repeals  
The following acts are repealed as from 21 April 2021:  
– Regulation (EU) No 206/2010;  
– Implementing Regulation (EU) No 139/2013 ;  
– Regulation (EU) No 605/2010 ;  
– Regulation (EC) No 798/2008 ;  
– Decision No 2007/777/EC ;  
– Regulation (EC) No  119/2009 ;  
– Regul ation (EC) No 206/2009 ;  
– Regulation (EU) No 28/2012 ;  
– Regulation (EU) No 2016/759 . 
Article 184 
This Regulation shall enter into force on the day following that of its publication in the 
Official Journal of the European Union . 
It shall apply from 21 April 2021.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.   
EN 112  EN Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER