Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on Animal Health
Date: 2013-05-06
Institutions: European Commission
Subjects: animal breeding, animal health, disease prevention, food safety, health control, import (EU), infectious disease, marketing standard, transport of animals, veterinary inspection

EUROPEAN 
COMMISSION 

Brussels, 6.5.2013  
COM(2013) 260 final 

2013/0136 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on Animal Health 

{SWD(2013) 160 final} 
{SWD(2013) 161 final} 

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EXPLANATORY MEMORANDUM 

1. 

JUSTIFICATION AND OBJECTIVE 

Animal  health  is  a  concern  for  all  European  citizens.  This  concern  stems  from  the 
public  health,  food  safety  and  food  security  aspects,  which  are  related  to  animal 
health but also from the economic costs that animal disease outbreaks can trigger and 
the  animal  welfare  considerations,  including  the  implications  of  disease  control 
measures on animal welfare.  

At the same time, this proposal reflects the priorities of Smart Regulation1 by aiming 
to  simplify  the  existing  legal  framework  while  reflecting  stakeholders'  expectations 
in reducing administrative burdens.  

And finally, it reflects Commission priorities such as the smart growth objective of 
the  Europe  2020  strategy2  by  helping  the  sector  to  become  more  resilient  due  to 
active prevention measures and more flexible risk management. 

Problem analysis 

The  current  EU  animal  health  legislative  framework  involves  almost  50  basic 
directives  and  regulations  and  some  400  pieces  of  secondary  legislation,  some  of 
them adopted as early as 1964.  

The Commission launched an external evaluation in 2004 to thoroughly review the 
outcomes of EU action of animal health, leading to a new Animal Health Strategy in 
2007. A combination of circumstances made it imperative to re-evaluate our policy:  

(cid:121) 

(cid:121) 

(cid:121) 

(cid:121) 

The main elements of the existing policy were drawn up largely between 1988 
and 1995 when we were still a Community of twelve Member States; 

New  challenges  have  emerged.  Diseases  which  were  unknown  a  decade  ago 
have  appeared,  while  others,  such  as  foot  and  mouth  disease,  bluetongue  and 
avian  flu,  have  recently  presented  new  challenges,  reminding  us  that  they 
remain very serious risks; 

Trading  conditions  have  also  changed  radically  with  the  volume  of  trade  in 
animals  and  animal  products  increasing  greatly,  both  within  the  EU  and  with 
third countries; and  

Science, 
substantially. 

technology  and  our 

institutional 

framework  have  evolved 

A  number  of  problems  have  been  identified  in  respect  of  the  existing  legislation. 
Some relate to the general policy approach, namely:  

– 

The high complexity of the current Community Animal Health Policy (CAHP) 

1 
2 

COM(2010) 543 final "Smart Regulation in the European Union". 
COM(2010) 2020 "Europe 2020 - A strategy for smart, sustainable and inclusive growth". 

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– 

– 

The lack of an overall strategy 

An insufficient focus on disease prevention, with a particular focus on the need 
for increased biosecurity. 

Others were related to specific problems with the functioning of existing legislation, 
particularly:  

– 

Issues related to intra-Union trade in live animals. 

Both general and specific problems are either rectified in this law, or will be rectified 
in its delegated and implementing acts.  

Objectives of the proposal 

The  Animal  Health  Law  is  the  legal  framework  to  support  the  Animal  Health 
Strategy  for  the  EU,  published  in  2007.  The  general  objectives  as  outlined  in  the 
Strategy are:  

(cid:121) 

(cid:121) 

(cid:121) 

(cid:121) 

to  ensure  a  high  level  of  public  health  and  food  safety  by  minimising  the 
incidence of biological and chemical risks to humans; 

to  promote  animal  health  by  preventing/reducing  the  incidence  of  animal 
diseases, and in this way to support farming and the rural economy; 

improve  economic  growth/cohesion/competitiveness  assuring 

to 
circulation of goods and proportionate animal movements; 

free 

to promote farming practices and animal welfare which prevent animal health 
related  threats  and  minimise  environmental  impacts  in  support  of  the  EU 
Sustainable Development Strategy.  

The specific objectives of this Animal Health Law are: 

(cid:121) 

(cid:121) 

(cid:121) 

(cid:121) 

to  establish  a  single,  simplified,  transparent  and  clear  regulatory  framework 
that  sets  out  systematically  the  objectives,  scope  and  principles  of  regulatory 
intervention; based on good governance and compliant with international (e.g. 
OIE)  standards;  focusing  on  long-term  preventative  measures  and  working 
together with all relevant stakeholders; 

to  introduce  overarching  general  principles  allowing  a  simplified  legal 
framework in order to be prepared for the new challenges, i.e. to enable quick 
reaction  in  case  of  emerging  diseases;  whilst  ensuring  the  same  quality  of 
reaction as provided for in current legislation; 

to ensure consistency amongst the horizontal principles of the legislation in the 
field  of  animal  health,  animal  welfare  and  food  safety  policies  as  well  as 
broader  EU  policies  on  climate  change,  common  agricultural  policy  and 
sustainability; 

to  reduce  the  impact  of  animal  diseases  on  animal  and  public  health,  animal 
welfare,  economy  and  society  as  far  as  possible  by  enhancing  disease 

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awareness,  preparedness,  surveillance  and  emergency  response  systems  at 
national and EU level;  

(cid:121) 

to ensure the smooth functioning of the internal market of animals and animal 
products, with a high level of protection of animal health and public health and 
supporting the objectives of Europe 2020. 

The operational objectives of this Animal Health Law are:  

(cid:121) 

(cid:121) 

(cid:121) 

(cid:121) 

(cid:121) 

(cid:121) 

(cid:121) 

(cid:121) 

to integrate the new prevention-driven and incentive-oriented approach into the 
core of animal health policy; 

to  provide  for  a  clear  and  balanced  distribution  of  roles  and  responsibilities 
between  competent  authorities,  EU  institutions,  the  farming  sector,  animal 
owners and others; 

to introduce disease categorization as the basis for EU intervention; 

to  provide  for  effective  mechanisms  for  a  rapid  response  to  disease  events, 
including new challenges, such as emerging diseases; 

to  ensure  effective  emergency  preparedness  and  early  response  to  animal 
diseases and zoonoses, including use of vaccines as appropriate; 

to  introduce  simplified  procedures,  wherever  possible  for  technical  and  other 
reasons,  taking  into  account  the  specificity  of  small  farmers  and  micro 
businesses and releasing unjustified administrative burdens and costs, wherever 
possible; 

to  ensure  that  the  new  legal  framework  provides  enough  flexibility  to  adapt 
smoothly to future scientific and technological developments; 

to  reduce  the  risk  of  trade  disruption  by  seeking  an  appropriate  level  of 
convergence  with  relevant  international  standards,  while  ensuring  a  firm 
commitment to high standards of animal health.  

2. 

LEGAL CONTEXT 

Legal Basis 

Articles  43,  114  and  168  of  the  Treaty  on  the  Functioning  of  the  European  Union 
(TFEU) provide the legal basis for the EU legislative measures on animal health, as 
they are an essential part of EU agricultural, public health and consumer protection, 
trade and single market policy.  

– 

Article 43 provides the basis for the EU legislative measures on the Common 
Agricultural Policy. This article also became the basis for veterinary legislation 
as the CAHP is considered from a legal perspective to be part of the Common 
Agricultural  Policy,  so  adopting  the  same  legislative  and  administrative 
procedures.  

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– 

– 

Article 114 provides the legal basis for the establishment and functioning of the 
internal  market  and  the  approximation  of  provisions  laid  down  by  the  law, 
regulation or administrative actions in this respect.  

Article 168 on health protection refers to the protection of human health from 
all  causes  that  may  damage  it,  including  those  related  to  animal  health. 
Veterinary  measures  directly  aimed  at  protecting  public  health were also 
adopted under the co-decision procedure as a result of this article.".  

Consistency with other Union policies 

This  set  of  animal  health  legislation  interacts  with  the  legal  framework  on  animal 
welfare,  food  safety,  public  health,  animal  nutrition,  veterinary  medicinal  products, 
environmental protection, official controls, the Common Fisheries Policy (CFP) and 
the Common Agricultural Policy (CAP).  

Relationship to other proposals in the package 

The proposal is part of a package of four reviews relating to animal health, health of 
plants, quality of plant reproductive material and official controls of plants, animals, 
food and feed.  

The  revision  of  the  official  controls  regulation  enables  official  controls  to  be  more 
consistently  applied  for  the  purposes  of  protection  of  animal  health  and  links  more 
coherently with animal health regulation.  

3. 

SUBSIDIARITY AND PROPORTIONALITY 

Subsidiarity 

Good  animal  health  generates  not  only  private  benefits  but  is  a  public  good  with 
wider societal benefits. The transmissible nature of many animal diseases means that 
a common approach, rather than a series of individual actions, will have the greatest 
overall benefits.  

The  value  of  the  harmonised  EU  approach  is  widely  accepted  and  has  helped  to 
reduce the administrative burden for operators, traders, veterinarians and veterinary-
related industries. It has played a key role in the establishment of the single market, 
facilitating  intra-EU  trade  in  animals  and  animal  products  (meat,  milk,  etc.)  by 
setting  up  harmonised  animal  health  conditions  and  promoting  the  success  of  the 
CAP.  

The  benefits  of  harmonised  rules  for  the  prevention,  notification,  control  and 
eradication  of  animal  diseases  at  EU  level  have  been  demonstrated  during  animal 
disease  outbreaks  in  recent  times.  The  response  to  these  crises  showed  the  EU's 
capability  to  react  quickly,  limiting  the  spread  of  diseases  and  minimising  their 
impacts.  This  was  largely  due  to  the  harmonised  approach  to  disease  control, 
including  providing  financial  compensation  for  the  losses  on  farms  due  to  disease 
eradication  measures.  Also,  taking  into  account  the  single  market  dimension,  the 
failure to control a disease in one Member State, may severely affect the health status 
of the Union and jeopardise its export potential. In light of these different elements, 
EU action is justified, as it is clear that MS cannot achieve this satisfactorily acting 

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alone  and  that  the  EU  would  achieve  a  consistent  approach  more  effectively  and 
efficiently. 

Proportionality  

The Animal Health Law establishes a general framework for the prevention, control 
and eradication of animal diseases. This framework is built on outcome-based rules, 
avoiding  over-prescriptiveness,  and  leaving  room  for  MS  to  regulate  or  set  more 
detailed legislation when necessary, so providing for the flexibility to adapt the rules 
to national, regional or local circumstances. On the other hand, rules on trade must 
necessarily have a certain level of detail and precision to reduce the risk of different 
implementation  practices  by  operators  and  competent  authorities  and  subsequent 
distortion of competition and possible reduction in the coherence of the approach to 
tackling  disease.  Therefore  the  Animal  Health  Law  tries  to  achieve  the  balance  of 
proportional but necessary action.  

4. 

CONSULTATIONS  WITH 
ASSESSMENTS 

INTERESTED  PARTIES  AND 

IMPACT 

Consultation process 

This Animal Health Law is the result of a long series of considered analyses.  

In  2004,  the  Commission  launched  an  independent  evaluation  to  assess  the 
performance  of  the  Community  Animal  Health  Policy  (CAHP)3  over  the  previous 
decade and its coherence with other EU policy interventions. The aim was to identify 
elements  of  the  CAHP  which  could  be  further  improved  and  to  propose  options  to 
achieve these improvements.  

Among  other  things,  the  CAHP  evaluation  recommended  that  a  single  strategy  for 
animal  health  be  developed  to  prevent  piecemeal  and  crisis-driven  development  of 
policy. The EU Animal Health Strategy 2007-2013 (AHS) "Prevention is better than 
cure" was the result4. 

The  AHS  provides  for  the  adoption  of  a  "single  regulatory  framework  for  animal 
health  with  a  greater  focus  on  incentives  than  penalties,  consistent  with  other  EU 
policies  and  converging  to  international  standards"  and  which  will  "define  and 
integrate  common  principles  and  requirements  of  existing  legislation".  In  their 
reaction  to  the  Commission  Communication  on  the  new  Strategy,  the  European 
Parliament5,  the  Council6  and  the  European  Economic  and  Social  Committee7 
welcomed this initiative. Subsequently, the Action Plan for the implementation of the 
Strategy8 confirmed that "the main objective of the Strategy is the development of an 
EU Animal Health Law". 

3 
4 
5 
6 
7 
8 

http://ec.europa.eu/food/animal/diseases/strategy/cahpeval_en.htm 
http://ec.europa.eu/food/animal/diseases/strategy/index_en.htm 
EP Resolution 2007/2260(INI). 
Doc.15481/07 ADD 1. 
NAT/376 – EU Animal Health Strategy. 
COM (2008) 545 final, http://ec.europa.eu/food/animal/diseases/strategy/documents_en.htm 

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From  the  very  start  of  the  process,  key  stakeholders,  Member  States  (MS), 
Competent  Authorities  (CA),  international  organisations  and  trading  partners  have 
been closely involved and have played a  crucial role in the discussion. In addition, 
economic and social stakeholders such as European associations  with an interest in 
animal health and welfare and the interested public have been consulted on a number 
of occasions in accordance with the Commission’s standards for consultation.  

5. 

ELEMENTS OF THE PROPOSAL 

Part I: General Rules 

The  Animal  Health  Law  sets  out  general  principles  for  good  animal  health  in  EU 
legislation.  It  brings  together  animal  health  measures  for  terrestrial  and  aquatic 
animals.  

Part  I  also  provides  for  the prioritisation and listing  of  diseases  which  are  likely  to 
have a significant impact. For the first time, this will enable Union resources to be 
systematically prioritised on a scientific and evidential basis.  

The responsibilities of all the different actors having a key role in the safeguarding of 
animal  health,  such  as  operators,  veterinarians,  and  pet  keepers,  are  explicitly  laid 
down  for  the  first  time.  In  particular,  operators  and  animal  professionals  are  now 
required to acquire a basic knowledge of animal health and related matters.  

Part II: Notification, Surveillance, Eradication Programmes, Disease Freedom 

Part II clarifies the responsibilities for notification and surveillance including animal 
health  visits.  It  clarifies  the  roles  of  operators,  competent  authorities  and  others  as 
regards  surveillance  of  the  animal  health  situation  in  the  Union.  The  new  system 
allows  for  better  use  of  the  synergies  between  surveillance  undertaken  by  the 
different  actors  in  the  field  to  ensure  the  most  effective  and  cost  efficient  use  of 
surveillance resources. 

Another main change here is that compartments, permitted only for Avian Influenza 
related measures and in aquaculture at present, can now be used more widely. This 
introduces more flexibility into disease control measures, introducing the possibility 
of continuing movements and trade under certain circumstances, considered from a 
risk-based perspective.  

Part III: Disease Preparedness, Awareness and Control 

Part  III  continues  to  require  MSs  to  draw  up  contingency  plans  for  dealing  with 
certain diseases, and to practise their implementation.  

The regulatory framework for vaccination is now explicitly and coherently provided 
for.  

The rules for the use of antigen, vaccine and reagent banks are laid down.  

Rules  on  control  measures  to  be  taken  in  the  case  of  suspicion  of  or  confirmed 
disease outbreaks of certain diseases are laid down, with little change to the existing 
system, which is considered to work well.  

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Part  IV:  Requirements  Concerning  Registration,  Approval,  Traceability  and 
Movements 

Part IV is split into three titles, with distinct rules for terrestrial, aquatic,  and other 
animals.  It  is  necessary  to  consider  them  separately  because  of  their  different 
production methods and epidemiology. The titles dealing with aquatic and terrestrial 
animals  lay  down  measures  which  help  to  identify  and  trace  animals  and 
establishments. The traceability of animals is of crucial importance during a disease 
outbreak  so  that  the  epidemiology  of  the  disease  is  understood  and  can  be  better 
controlled.  These  titles  also  introduce  the  possibility  for  more  animals  to  be 
registered  and  traced  through  electronic  means,  promoting  simplicity  and  better 
regulation,  and  reducing  administrative  burden  through  the  use  of  technology.  A 
third  title  on  other  animals  is  introduced  only  for  possible  future  provision,  should 
new threats emerge in relation to these animals.  

Part V: Entry into the Union and Export 

Part  V  sets  the  standards  and  requirements  for  third  countries  sending  animals, 
germinal  products,  products  of  animal  origin  and  other  material  that  may  transmit 
animal diseases into the Union, in order to prevent diseases being introduced. It also 
sets  out  requirements  for  export.  No  practical  changes  are  envisaged  from  existing 
legislation, which is considered to function well.  

Part VI: Emergency Measures 

Emergency  measures  are  a  crucial  part  of  disease  management.  Part  VI  lays  down 
the procedures to be followed in case of emergency, ensuring a rapid and consistent 
Union  response.  Only  a  few  practical  changes  are  envisaged  from  existing 
legislation, which is considered to function very well. 

Part VII: Final and Transitional Provisions 

The  final  and  transitional  provisions  set  out  the  national  provisions,  the  conditions 
for adopting delegated acts, repeals, and other necessary legal provisions.  

6. 

BUDGETARY IMPLICATIONS 

This  proposal  does  not  imply  expenditures  which  are  not  already  included  in  the 
financial statement of the common financial framework for food chain, animal health 
and welfare, and relating to plant health and plant reproductive material. 

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2013/0136 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on Animal Health 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 43(2), Article 114(3) and Article 168(4)(b) thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national Parliaments, 

Having regard to the opinion of the European Economic and Social Committee9,  

Having regard to the opinion of the Committee of the Regions10,  

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

The  impact  of  transmissible  animal  diseases  and  the  measures  necessary  to  control 
these  diseases  can  be  devastating  for  individual  animals,  animal  populations,  animal 
keepers and the economy.  

As recent experiences have demonstrated, transmissible animal diseases may also have 
a significant impact on public health, as for example in the case of avian influenza and 
salmonella.  

In  addition,  adverse  interactive  effects  can  be  observed  with  regard  to  biodiversity, 
climate  change  and  other  environmental  aspects.  Climate  change  may  influence  the 
emergence  of  new  diseases,  the  prevalence  of  existing  diseases  and  the  geographic 
distribution of disease agents and vectors, including those affecting wildlife. 

In order to ensure high standards of animal and public health in the Union, the rational 
development  of  the  agriculture  and  aquaculture  sectors  and  to  increase  productivity, 
animal  health  rules  should  be  laid  down  at  Union  level.  These  rules  are  necessary, 
inter  alia,  to  contribute  to  the  completion  of  the  internal  market,  and  to  avoid  the 
spread of infectious diseases.  

9 
10 

OJ C , , p. . 
OJ C , , p. . 

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(5) 

(6) 

(7) 

(8) 

The  current  Union  animal  health  legislation  consists  of  a  series  of  linked  and 
interrelated  basic  acts  that  lay  down  rules  on  animal  health  applying  to  intra-Union 
trade,  entry  into  the  Union  of  animals  and  products,  disease  eradication,  veterinary 
controls,  notification  of  diseases  and  financial  support  in  relation  to  different  animal 
species, but an overarching legal framework, providing  harmonised  principles across 
the sector is missing.  

The Animal Health Strategy for the Union (2007– 2013) proposes that ‘Prevention is 
better  than  cure’  and  was  adopted  by  the  Commission  in  its  Communication  of  19 
September 2007 to the European Parliament, the Council, the European Economic and 
Social Committee and the Committee of the Regions11. It aims to put greater focus on 
preventive  measures,  disease  surveillance,  disease  control  and  research,  in  order  to 
reduce  the  incidence  of  animal  diseases  and  minimise  the  impact  of  outbreaks  when 
they  do  occur.  It  proposes  the  adoption  of  a  “single  and  simplified  regulatory 
framework  for  animal  health”  seeking  convergence  to  international  standards  while 
ensuring a firm commitment to high standards of animal health. 

The aim of this Regulation is to implement the commitments and visions provided for 
in  that  Animal  Health  Strategy,  including  the  "One  health"  principle,  and  to 
consolidate the legal framework for a common Union animal health policy through a 
single, simplified, and flexible regulatory framework for animal health. 

Animals may suffer from a broad range of infectious or non-infectious diseases. Many 
diseases can be treated, have an impact only on the individual animal concerned or do 
not  spread  to  other  animals  or  to  humans.  On  the  other  hand,  transmissible  diseases 
may have a broader impact on animal or public health with effects felt on a population 
level. The animal health rules laid down in this Regulation should only be limited to 
those latter diseases. 

(9) 

In laying down those animal health rules, it is essential that considerations are given to 
the  link  between  animal  health  and  public  health,  the  environment,  food  and  feed 
safety, animal welfare, food security, economic, social and cultural aspects. 

(10)  Council  Decision  94/800/EC  of  22 December 1994  concerning  the  conclusion  on 
behalf of the European Community, as regards matters within its competence, of the 
agreements  reached  in  the  Uruguay  Round  multilateral  negotiations  (1986-1994)12 
approved  on  behalf  of  the  then  European  Community,  with  regard  to  that  portion  of 
those matters which falls within its competence the Agreement establishing the World 
Trade Organization (WTO), and also the Agreements set out in Annexes 1, 2 and 3 to 
that  Agreement  which  include  the  Agreement  on  the  Application  of  Sanitary  and 
Phytosanitary  Measures  (SPS  Agreement).  The  SPS  Agreement  regulates  the  use  of 
measures necessary to protect human, animal or plant life or health so that they do not 
arbitrarily  or  unjustifiably  discriminate  between  WTO  members.  If  international 
standards exist, they are required to be used as a basis. However, the members have 
the right to set their own relevant standards provided that such standards are based on 
scientific evidence.  

11 
12 

COM (2007) 539 final. 
OJ L 336, 23.12.1994, p. 1. 

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(11)  As  regards  animal  health  the  SPS  Agreement  refers  to  the  standards  of  the  World 
Organisation  for  Animal  Health  (OIE)  as  regards  animal  health  conditions  for 
international  trade.  In  order  to  reduce  the  risk  of  trade  disruption,  EU  measures  on 
animal health should aim for an appropriate level of convergence with OIE standards. 

(12) 

In  specific  circumstances  where  a  significant  animal  or  public  health  risk  exists  but 
scientific  uncertainty  persists,  Article  5(7)  of  the  SPS  Agreement  which  has  been 
interpreted for the Union in the Communication from the Commission of 2 February 
2000  on  the  precautionary  principle13  allows  a  Member  of  that  agreement  to  adopt 
provisional  measures  on  the  basis  of  available  pertinent  information.  In  such 
circumstances,  the  WTO  Member  is  required  to  obtain  the  additional  information 
necessary for a more objective assessment of risk and review the measure accordingly 
within a reasonable period of time.  

(13)  The  risk  assessment,  on  the  basis  of  which  the  measures  under  this  Regulation  are 
taken,  should  be  based  on  the  available  scientific  evidence  and  undertaken  in  an 
independent,  objective  and  transparent  manner.  Due  account  should  also  be  taken  of 
the  opinions  of  the  European  Food  Safety  Authority  established  by  Article  22(1)  of 
Regulation  (EC)  No  178/2002  of  the  European  Parliament  and  of  the  Council  of  28 
January  2002  laying  down  the  general  principles  and  requirements  of  food  law, 
establishing  the  European  Food  Safety  Authority  and  laying  down  procedures  in 
matters of food safety14. 

(14)  Regulation  (EC)  No  1069/2009  of  the  European  Parliament  and  the  Council  of 
21 October 2009 laying down health rules as regards animal by-products and derived 
products  not  intended  for  human  consumption  and  repealing  Regulation  (EC)  No. 
1774/2002  (Animal  by-products  Regulation)15  lays  down  both  public  and  animal 
health  rules  for  certain  animal  by-products  and  derived  products  in  order  to  prevent 
and  minimise  risks  to  public  and  animal  health  arising  from  those  products,  and  in 
particular to protect the safety of the food and feed chain. In order to avoid any overlap 
of  Union  legislation,  this  Regulation  should  therefore  only  apply  to  animal  by-
products  and  derived  products  where  specific  rules  are  not  laid  down  in  Regulation 
(EC)  No  1069/2009,  and  where  an  animal  health  risk  is  involved.  For  instance, 
Regulation  (EC)  No  1069/2009  does  not  regulate  how  to  handle  animal  by-products 
and  derived  products  in  the  context  of  disease  control  measures,  and  so  these  issues 
are duly covered by this Regulation.  

(15) 

transmissible  animal  diseases 

In  addition,  specific  rules  on 
those 
transmissible  to  humans  ("zoonoses")  are  already  laid  down  in  Regulation  (EC)  No 
999/2001 of the European Parliament and of the Council of 22 May 2001 laying down 
rules  for  the  prevention,  control  and  eradication  of  certain  transmissible  spongiform 
encephalopathies16,  Directive  2003/99/EC  of  the  European  Parliament  and  of  the 
Council  of  17  November  2003  on  the  monitoring  of  zoonoses  and  zoonotic  agents, 
amending  Council  Decision  90/424/EEC  and 
repealing  Council  Directive 
92/117/EEC17 and Regulation (EC) No 2160/2003 of the European Parliament and of 

including 

13 
14 
15 
16 
17 

COM(2000) 1 final. 
OJ L 31, 1.2.2002, p. 1. 
OJ L 300, 14.11.2009, p. 1. 
OJ L 147, 31.5.2001, p. 1. 
OJ L 325, 12.12.2003, p. 31. 

EN 

11 

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the  Council  of  17  November  2003  on  the  control  of  salmonella  and  other  specified 
food-borne zoonotic agents18, and specific rules on communicable diseases in humans 
in  Decision  No  2119/98/EC  of  the  European  Parliament  and  of  the  Council  of  24 
September 1998 setting up a network for the epidemiological surveillance and control 
of  communicable  diseases  in  the  Community19.  Those  acts  should  remain  in  force 
following the adoption of this Regulation. Accordingly, in order to avoid any overlap 
of Union legislation, this Regulation should only apply to zoonoses to the extent that 
specific rules are not already laid down in those other Union acts. 

(16)  Diseases  occurring  in  wild  animal  populations  may  have  a  detrimental  effect  on  the 
agriculture  and  aquaculture  sectors,  on  public  health, 
the  environment  and 
biodiversity.  It  is  therefore  appropriate  that  the  scope  of  this  Regulation  should,  in 
such cases, cover wild animals, both as potential victims of those diseases and as their 
vectors.  

(17)  Animal  diseases  are  not  only  transmitted  through  direct  contact  between  animals  or 
between animals and humans. They are also carried further afield through water and 
air systems, vectors such as insects, or the semen, ova and embryos used in artificial 
insemination,  ovum  donation  or  embryo  transfer.  Disease  agents  may  also  be 
contained  in  food  and  other  products  of  animal  origin  such  as  leather,  fur,  feathers, 
horn  and  any  other  material  derived  from  the  body  of  an  animal.  Moreover  various 
other  objects  such  as  transport  vehicles,  equipment,  fodder  and  hay  and  straw  may 
diffuse disease agents. Therefore, effective animal health rules need to cover all paths 
of infection and material involved therein. 

(18)  Animal diseases may have detrimental effects on the distribution of animal species in 
the  wild,  and  thus  affect  biodiversity.  Microorganisms  causing  animal  diseases  can 
therefore  fall  within  the  definition  of  invasive  alien  species  of  the  United  Nations 
Convention on Biological Diversity. The measures provided for in this Regulation also 
take account of biodiversity and thus this Regulation should cover animal species and 
disease agents, including those defined as invasive animal species, which play a role in 
the transmission of, or are affected by, diseases covered by this Regulation.  

(19) 

In Union legislation adopted prior to this Regulation separate animal health rules are 
laid  down  for  terrestrial  and  aquatic  animals.  Council  Directive  2006/88/EC  of 
24 October 2006 on animal health requirements for aquaculture animals and products 
thereof, and on the prevention and control of certain diseases in aquatic animals20 lays 
down  specific  rules  for  aquatic  animals.  Yet  in  most  cases,  the  main  principles  for 
good  animal  health  governance  are  applicable  to  both  groups  of  animal  species. 
Accordingly,  the  scope  of  this  Regulation  should  cover  both  terrestrial  and  aquatic 
animals  and  aligns  those  animal  health  rules  where  applicable.  However,  for  certain 
aspects,  in  particular  the  registration  and  approval  of  establishments  and  the 
traceability  and  movements  of  animals  within  the  Union,  this  Regulation  adheres  to 
the approach adopted in the past, which was to lay down different sets of animal health 
rules  for  terrestrial  and  aquatic  animals  due  to  their  different  environments  and 
accordingly different requirements to safeguard health. 

18 
19 
20 

OJ L 325, 12.12.2003, p. 1. 
OJ L 268, 3.10.1998, p. 1. 
OJ L 328, 24.11.2006, p 14. 

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12 

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(20)  Union legislation adopted prior to this Regulation and in particular Council Directive 
92/65/EEC of 13 July 1992 laying down animal health requirements governing trade 
in and imports into the Community of animals, semen, ova and embryos not subject to 
animal  health  requirements  laid  down  in  specific  Community  rules  referred  to  in 
Annex  A (I) to  Directive  90/425/EEC21 also lays down basic animal health  rules for 
other  animal  species  not  regulated  in  other  Union  acts,  such  as  reptiles,  amphibians, 
marine mammals, and others which are not aquatic or terrestrial animals as defined in 
this  Regulation.  Usually,  such  species  do  not  represent  a  significant  health  risk  for 
humans or other animals and therefore only a few animal health rules, if any, apply. In 
order  to  avoid  unnecessary  administrative  burdens  and  costs,  this  Regulation  should 
adhere to the approach adopted in the past, namely to provide the legal framework for 
detailed  animal  health  rules  for  movements of  such animals  and their products to be 
laid down if the risks involved so require. 

(21)  The keeping of pet animals, including ornamental aquatic animals in households and 
non-commercial ornamental aquaria, both indoors and outdoors, generally represents a 
lower health risk compared to other ways of keeping or moving animals on a broader 
scale,  such  as  those  common  in  agriculture.  Therefore,  it  is  not  appropriate  that  the 
general  requirements  concerning  registration,  record  keeping  and  movements  within 
the Union apply to such animals, as this would represent an unjustified administrative 
burden  and  cost.  Registration  and  record  keeping  requirements  should  therefore  not 
apply  to  pet  keepers.  In  addition,  specific  rules  should  be  laid  down  for  non-
commercial movements of pet animals within the Union. 

(22)  Some  defined  groups  of  animals,  for  which  special  animal  health  rules  exist  in  this 
Regulation,  need  to  be  listed  as  species  in  an  Annex,  due  to  the  broad  scope  of  the 
group. This is the case for the group of hoofed mammals classified as ungulates. This 
list  may  need  to  be  changed  in  the  future  due  to  reasons  of  changed  taxonomy, 
scientific development or technical updates justified by science. Similarly, the list of 
species  of  pet  animals  may  need  to  be  adjusted  due  to  developments  in  society,  or 
changed  habits  of  keeping  pet  animals,  in  particular  where  these  animals  transmit 
diseases. Therefore, in order to take account of such changes, the power to adopt acts 
in  accordance  with  Article  290  of  the  Treaty  on  the  Functioning  of  the  European 
Union should be delegated to the Commission in respect of the lists of pet animals and 
ungulates set out in Annexes I and II to this Regulation.  

(23)  Not  all  transmissible  animal  diseases  can  or  should  be  prevented  and  controlled 
through regulatory measures, for example, if the disease is too widespread, diagnostic 
tools are not available, or if the private sector can take measures to control the disease 
by  itself.  Regulatory  measures  to  prevent  and  control  transmissible  animal  diseases 
may have important economic consequences for the relevant sectors and disrupt trade. 
It  is  therefore  essential  that  such  measures  are  only  applied  when  proportionate  and 
necessary, such as when a disease presents or is suspected to present a significant risk 
to animal or public health.  

(24)  Furthermore,  the  preventive  and  control  measures  for  each  transmissible  animal 
disease should be "tailor-made" in order to address its unique epidemiological profile 

21 

OJ L 268, 14.9.1992, p. 54. 

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13 

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and  its  consequences.  The  preventive  and  control  rules  applying  to  each  of  them 
should therefore be disease specific. 

(25)  For  transmissible  animal  diseases  a  disease  condition  is  usually  associated  with 
clinical or pathological manifestation of the infection. However, for the purpose of this 
Regulation,  which  aims  to  control  the  spread  of  and  eradicate  certain  transmissible 
animal  diseases,  the  disease  definition  should  be  wider  in  order  to  include  other 
carriers of the disease agent. 

(26)  Some transmissible animal diseases do not easily spread to other animals or to humans 
and  thus  do  not  cause  economic  or  biodiversity  damage  on  a  wide  scale.  Therefore, 
they do not represent a serious threat to animal or public health in the Union and can 
thus, if desired, be addressed by national rules.  

(27)  For transmissible animal diseases that are not subject to measures laid down at Union 
level,  but  which  are  of  some  economic  importance  for  the  private  sector  at  a  local 
level, the latter should, with the assistance of the competent authorities of the Member 
States,  take  actions  to  prevent  or  control  such  diseases,  for  instance  through  self-
regulatory measures or the development of codes of practice. 

(28) 

In contrast to the transmissible animal diseases described in recitals 26 and 27, highly 
transmissible animal diseases may easily spread across borders and, if they are also a 
zoonosis, they may also have an impact on public health and food safety. Hence highly 
transmissible animal diseases and zoonoses should be covered by this Regulation.  

(29)  Action No. 5 of the Communication from the Commission to the European Parliament 
and  the  Council  –  Action  plan  against  the  rising  threats  from  Antimicrobial 
Resistance22  emphasises  the  preventive  role  of  this  Regulation  and  the  consequent 
expected reduction of the use of antibiotics in animals. Resistance of microorganisms 
to  antimicrobials  to  which  they  were  previously  responsive  is  increasing.  This 
resistance complicates the treatment of infectious diseases in humans and animals. As 
a  result,  microorganisms  that  have  developed  resistance  to  antimicrobials  should  be 
treated  as  if  they  were  transmissible  diseases,  and  thus  covered  by  the  scope  of  this 
Regulation. 

(30)  New hazards associated with certain diseases or species may develop in particular due 
to changes in the environment, the climate, animal husbandry, farming traditions but 
also through social changes. Scientific progress may also lead to new knowledge and 
increased  awareness  concerning  existing  diseases.  Furthermore,  diseases  and  species 
that are important today may be marginalised in the future. Therefore the scope of this 
Regulation  should  be  broad  and  the  rules  laid  down  should  be  focused  on  diseases 
with  high  public  relevance.  The  OIE  has,  with  the  support  of  the  European 
Commission,  developed  a  system  of  disease  prioritisation  and  categorisation,  by 
producing  a  study  on  the  "Listing  and  categorisation  of  priority  animal  diseases, 
including  those  transmissible  to  humans"23  and  a  tool  for  such  an  exercise.  This 
Regulation should introduce such an approach in Union legislation.  

22 
23 

COM (2011) 748. 
http://www.oie.int/en/support-to-oie-members/global-studies/categorisation-of-animal-diseases/ 

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(31) 

In  order  to  ensure  uniform  conditions  for  the  implementation  of  this  Regulation  in 
relation to transmissible animal diseases at Union level, it is necessary to establish a 
harmonised list of transmissible animal diseases ('listed diseases'). Thus implementing 
powers to lay down such a list should be conferred on the Commission.  

(32)  Emerging diseases with the potential to cause serious public or animal health risks and 
impacts  on  health,  the  economy  or  the  environment  may  appear  in  the  future. 
Following  the  assessment  of  such  diseases  and  after  adopting  temporary  emergency 
measures, when relevant, a quick reaction and insertion of such diseases in the list of 
listed diseases may be necessary. Therefore the power to adopt acts in accordance with 
the urgency procedure should be delegated to the Commission in these duly justified 
cases of risks to public or animal health. 

(33)  Listed  diseases  will  require  different  management  approaches.  Some  highly 
contagious  diseases  which  are  currently  not  present  in  the  Union  require  stringent 
measures to immediately eradicate them as soon as they occur. For other diseases that 
might already be present in parts of the Union, compulsory or voluntary eradication is 
required. In both cases, it is appropriate to put in place restrictions on movements of 
animals and products, such as a prohibition of movements to and from affected areas, 
or simply testing prior to dispatch. In other instances it might be appropriate only to 
implement surveillance of the disease's distribution, without taking further measures. 
This  would  be  the  case,  in  particular,  in  the  event  of  an  emerging  disease  for  which 
there is limited information.  

(34)  Criteria  should  be  laid  down  to  ensure  that  all  relevant  aspects  are  considered  when 
determining which transmissible animal diseases should be listed for the purposes of 
this  Regulation  and  to  determine  the  applicability  of  disease  prevention  and  control 
rules  of  the  Regulation  to  the  different  listed  diseases  to  ensure  coherence  and 
consistency. In order to ensure that technical and scientific progress and developments 
of  relevant  international  standards  are  taken  into  account,  the  power  to  adopt  acts  in 
accordance with Article 290 of the Treaty on the Functioning of the European Union 
should  be  delegated  to  the  Commission  with  respect  to  the  possible  amendments  of 
those criteria.  

(35)  The prevention and control rules of this Regulation for a specific transmissible animal 
disease should apply to species of animals which can transmit the disease in question, 
by  being  susceptible  to  it  or  by  acting  as  its  vector.  In  order  to  ensure  uniform 
conditions  for  the  implementation  of  this  Regulation,  it  is  necessary  to  establish  a 
harmonised  list  of  species  to  which  the  measures  for  specific  listed  diseases  should 
apply at Union level ('listed species') and thus implementing powers to lay down such 
a list should be conferred on the Commission. 

(36)  Based  on  the  importance  and  the  level  of  impact  of  a  listed  disease,  its  distribution, 
prevalence and incidence in the Union and the availability of disease prevention and 
control  measures  in  respect  of  that  listed  disease,  a  different  category  of  specific 
disease  prevention  and  control  rules  provided  for  in  this  Regulation  should  apply 
coherently and consistently to each listed disease.  

(37) 

In  order  to  ensure  uniform  conditions  for  the  implementation  of  this  Regulation  in 
relation to the disease prevention and control measures applicable to listed diseases, it 
is necessary to determine the application of the rules, provided for in this Regulation, 

EN 

15 

   EN 

to listed diseases at Union level. Thus implementing powers to lay down which listed 
diseases are to be subject to which rules, should be conferred on the Commission.  

(38)  Operators, animal professionals and pet keepers working with animals are in the best 
position  to  observe  and  ensure  the  health  of  the  animals  and  products  under  their 
responsibility.  They  should  therefore  hold  primary  responsibility  for  carrying  out 
measures for the prevention and control of the spread of diseases among animals and 
products under their responsibility.  

(39)  Biosecurity is one of the key prevention tools at the disposal of operators, and others 
working  with  animals  to  prevent  the  introduction,  development  and  spread  of 
transmissible  animal  diseases  to,  from  and  within  an  animal  population.  The  role  of 
biosecurity  is  also  recognised  in  the  Impact  Assessment  for  the  adoption  of  the  EU 
Animal Health Law and possible impacts are specifically assessed. In order to ensure 
that  the  biosecurity  measures  applied  by  operators,  animal  professionals  and  pet 
keepers  are  sufficiently  flexible,  that  they  are  adjusted  to  suit  the  type  of  production 
and  the  species  or  categories  of  animals  involved  and  that  they  take  account  of  the 
local circumstances and technical developments, the power to adopt acts in accordance 
with  Article  290  of  the  Treaty  on  the  Functioning  of  the  European  Union  should  be 
delegated  to  the  Commission  with  respect  to  supplementary  and  more  detailed 
biosecurity requirements.  

(40)  Biocidal products, such as disinfectants for veterinary hygiene or food and feed areas, 
insecticides, repellents or rodenticides play an important role in biosecurity strategies, 
both  at  farm  level  as  well  as  during  animal  transport.  They  should  therefore  be 
considered a part of biosecurity.  

(41)  Knowledge of animal health, including of disease symptoms, consequences of diseases 
and  possible  means  of  prevention  including  biosecurity,  treatment  and  control  is  a 
prerequisite for efficient animal health management and essential in ensuring the early 
detection  of  animal  diseases.  Operators  and  other  animal  professionals  should 
therefore acquire such knowledge as appropriate. That knowledge may be acquired by 
different  means,  for  example  formal  education,  but  also  through  the  Farm  Advisory 
System existing in the agricultural sector or by informal training to which national and 
European farmer organisations and other organisations may be valuable contributors. 
Those  alternative  means  of  acquiring  such  knowledge  should  also  be  recognised  by 
this Regulation. 

(42)  Veterinarians and aquatic animal health professionals play a crucial role in all aspects 
of  animal  health  management,  and  general  rules  concerning  their  roles  and 
responsibilities should be laid down in this Regulation.  

(43)  Veterinarians have the education and the professional qualifications which ensure that 
they  have  acquired  the  knowledge,  skills  and  competencies  necessary,  inter  alia,  to 
diagnose diseases and treat animals. In addition, in some Member States for historical 
reasons, or due to the lack of veterinarians dealing with aquatic diseases, there exists a 
specialised  profession  called  "aquatic  animal  health  professionals".  These 
professionals  are  traditionally  not  veterinarians  but  they  practice  aquatic  animal 
medicine.  This  Regulation  should  therefore  respect  the  decision  of  those  Member 
States  who  recognise  that  profession.  In  those  cases,  aquatic  animal  health 
professionals  should  have  the  same  responsibilities  and  obligations  as  veterinarians 

EN 

16 

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concerning  their  specific  area  of  work.  This  approach  is  in  line  with  the  Aquatic 
Animal Health Code of the OIE. 

(44) 

In order to ensure that the veterinarians and aquatic animal health professionals who 
undertake  activities  that  fall  within  the  scope  of  this  Regulation  are  adequately 
qualified and receive appropriate training, the power to adopt acts in accordance with 
Article  290  of  the  Treaty  on  the  Functioning  of  the  European  Union  should  be 
delegated to the Commission in respect to their qualification and training. 

(45)  Member States and in particular the competent authority thereof responsible for animal 
health are amongst the key actors in the prevention and control of transmissible animal 
diseases. The competent authority for animal health plays an important role in relation 
to  surveillance,  eradication,  disease  control  measures,  contingency  planning,  raising 
disease  awareness,  and  in  the  facilitation  of  animal  movements  and  in  international 
trade  by  the  issuing  of  animal  health  certificates.  To  be  able  to  perform  their  duties 
under this Regulation, Member States depend on having access to adequate financial, 
including 
infrastructural  and  personnel  resources 
laboratory capacity and scientific and other relevant know-how.  

throughout 

territories, 

their 

(46)  The competent authority cannot always perform all the activities required to be carried 
out  by  it  under  this  Regulation  due  to  the  limited  resources.  For  that  reason  it  is 
necessary  to  provide  a  legal  basis  for  the  delegation  of  the  performance  of  those 
activities  to  veterinarians.  In  order  to  ensure  that  the  necessary  conditions  are  laid 
down for the general application of disease prevention and control measures across the 
Union,  the  power  to  adopt  acts  in  accordance  with  Article  290  of  the  Treaty  on  the 
Functioning of the European Union should be delegated to the Commission in respect 
to  the  delegation  of  the  performance  of  those  activities  to  veterinarians  and  their 
appropriate training. 

(47)  Optimal animal health management can only be achieved in cooperation with animal 
keepers, operators, other stakeholders and trading partners. To secure their support it is 
necessary to organise decision making procedures and the application of the measures 
provided  for  in  this  Regulation  in  a  clear  and  transparent  manner.  Therefore  the 
competent  authority  should  take  appropriate  steps  to  keep  the  public  informed, 
especially when there are reasonable grounds to suspect that animals or products may 
present a risk for animal or public health and when a case is of public interest.  

(48)  To avoid the release of disease agents from laboratories, institutes and other facilities 
handling diseases agents it is vital that they take appropriate biosecurity, biosafety and 
bio-containment  measures.  This  Regulation  should  therefore  provide  for  safety 
measures to be observed while handling or transporting such disease agents, vaccines 
and other biological products. This obligation should also apply to any legal or natural 
person, who is involved in such an activity. In order to ensure that safety standards are 
respected  when  handling  highly  contagious  biological  agents,  vaccines  and  other 
biological  products,  the  power  to  adopt  acts  in  accordance  with  Article  290  of  the 
Treaty  on  the  Functioning  of  the  European  Union  should  be  delegated  to  the 
Commission  in  respect  of  the  safety  measures  in  those  laboratories,  institutes  and 
facilities and for movements of diseases agents. 

(49)  Early detection and a clear chain of disease notification and reporting are crucial for 
effective  disease  control.  In  order  to  achieve  an  efficient  and  quick  response  any 

EN 

17 

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suspicion  or  confirmation  of  an  outbreak  of  certain  listed  diseases  should  be 
immediately notified to the competent authority. Those notification obligations should 
be  applicable  to  any  natural  and  legal  person  in  order  to  ensure  that  no  disease 
outbreaks remain unnoticed. 

(50)  Veterinarians  are  key  actors  in  the  investigation  of  diseases  and  a  key  link  between 
operators  and  the  competent  authority.  Therefore,  they  should  be  notified  by  the 
operator  in  cases  of  abnormal  mortalities,  other  serious  disease  problems  or 
significantly decreased production rates with an undetermined cause.  

(51) 

In  order  to  ensure  the  effective  and  efficient  notification  and  to  clarify  different 
circumstances  related  to  abnormal  mortalities  and  other  serious  diseases  signs,  the 
power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of 
the  European  Union  should  be  delegated  to  the  Commission  in  respect  of  criteria  to 
determine  when  relevant  circumstances  for  the  notification  occur  and  the  rules  for 
further investigation, where this is relevant. 

(52)  For certain listed diseases it is vital that the Commission and the other Member States 
are  immediately  notified  about  diseases.  Such  Union  notification  will  enable 
neighbouring or other affected Member States to take precautionary measures when so 
warranted. In order to ensure uniform conditions for the implementation of such Union 
notification, implementing powers shall be conferred on the Commission. 

(53)  On  the  other  hand,  for  some  diseases  immediate  notification  and  action  are  not 
necessary. In those cases the gathering of information and reporting in relation to the 
occurrence  of  those  diseases  is  essential  to  control  the  disease  situation  and  where 
necessary to take disease prevention and control measures. This reporting requirement 
may  also  apply  to  diseases  which  are  subject  to  Union  notification  but  where 
additional  information  is  needed  for  the  implementation  of  effective  disease 
prevention  and  control  measures.  In  order  to  ensure  that  the  correct  information  and 
data, which are necessary to prevent the spread or to control each particular disease, 
are  collected  in  the  right  timeframe,  the  power  to  adopt  acts  in  accordance  with 
Article 290  of  the  Treaty  on  the  Functioning  of  the  European  Union  should  be 
delegated to the Commission concerning the matters to be reported. 

(54)  A key purpose of disease notification and reporting is to generate reliable, transparent 
and  accessible  epidemiological  data.  A  computerised  information  system  for  the 
effective  collection  and  management  of  surveillance  data  should  be  established  at 
Union  level  for  listed  diseases  and,  when  relevant,  for  emerging  diseases  or 
antimicrobial  resistant  pathogens.  That  system  should  promote  optimal  data 
availability, facilitation of  data  exchange,  and  reduction  of  administrative  burden  for 
the  competent  authorities  of  the  Member  States  by  merging  disease  notification  and 
reporting  within  the  Union  and  at  international  level  into  one  process  (that  is  the 
WAHIS/WAHID database of the OIE). Consistency with the exchange of information 
in accordance with Directive 2003/99/EC24 should also be ensured.  

(55) 

In  order  to  ensure  uniform  conditions  for  the  implementation  of  the  Union  disease 
notification  and  reporting  rules,  implementing  powers  should  be  conferred  on  the 
Commission to establish a list of diseases which are subject to Union notification and 

24 

OJ L 325, 12.12.2003, p. 31. 

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Union  reporting  rules  provided  for  in  this  Regulation  and  to  establish  the  necessary 
procedures,  formats,  data  and  information  exchanges  regarding  disease  notification 
and reporting. 

(56)  Surveillance is a key element of disease control policy. It should provide for the early 
detection of transmissible animal diseases and efficient notification, thereby enabling 
the  sector  and  the  competent  authority  to  implement,  where  feasible,  timely  disease 
prevention  and  control  measures,  and  the  eradication  of  a  disease.  Furthermore,  it 
should supply information on the animal health status of each Member State and the 
Union,  thereby  substantiating  disease  freedom  and  facilitating  trade  with  third 
countries. 

(57)  Operators  observe  their  animals  on  a  regular  basis  and  are  best  positioned  to  detect 
abnormal  mortalities  or  other  serious  disease  symptoms.  Operators  are  therefore  the 
cornerstone  of  any  surveillance  and  essential  for  the  surveillance  undertaken  by  the 
competent authority.  

(58)  To  ensure  close  collaboration  and  exchange  of  information  between  operators  and 
veterinarians or aquatic animal health professionals and to supplement the surveillance 
undertaken  by  operators,  establishments  should,  as  appropriate  for  the  type  of 
production  and  other  relevant  factors,  be  subject  to  animal  health  visits.  In  order  to 
ensure a proportionate level of surveillance to the risks involved in different types of 
establishments, the power to adopt acts in accordance with Article 290 of the Treaty 
on  the  Functioning  of  the  European  Union  should  be  delegated  to  the  Commission 
concerning the criteria and the content of such animal health visits in different types of 
establishments. 

(59) 

It is essential that the competent authority has in place a system of surveillance for the 
listed diseases which are subject to surveillance. This should also apply to emerging 
diseases,  where  the  potential  health  risks  of  that  disease  should  be  assessed  and 
epidemiological data collected for that assessment. To ensure the best use of resources 
information  should  be  collected,  shared  and  used  in  the  most  effective  and  efficient 
manner possible. 

(60)  The  surveillance  methodology,  frequency  and  intensity  should  be  adapted  to  each 
specific  disease  and  take  into  account  the  specific  purpose  of  the  surveillance,  the 
animal health status in the region concerned and any additional surveillance conducted 
by operators.  

(61) 

In some cases, and depending on the epidemiological profile of a disease and relevant 
risk factors, a structured surveillance programme may need to be put in place. In that 
case it is appropriate that Member States develop epidemiologically based surveillance 
programmes. The power to adopt acts in accordance with Article 290 of the Treaty on 
the  Functioning  of  the  European  Union  should  be  delegated  to  the  Commission 
concerning the surveillance design, the criteria for  official  confirmation  of outbreaks 
and  the  case  definitions  of  those  diseases  and  requirements  for  surveillance 
programmes in relation to their contents, information to be included and the period of 
application.  

(62)  To  promote  coordination  between  the  Member  States  and  ensure  that  those 
surveillance  programmes  are  consistent  with  Union  objectives,  they  should  be 

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submitted to the Commission and other Member States for information. Furthermore, 
the  Member  State  implementing  the  surveillance  programme  should  also  submit 
regular  reports  on  the  results  of  that  surveillance  programme  to  the  Commission.  In 
order 
implementation  of  surveillance 
programmes,  implementing  powers  should  be  conferred  on  the  Commission  to 
establish  a  list  of  diseases  subject  to  surveillance  programmes  and  to  set  up 
harmonised procedures, formats, data and information exchange. 

to  ensure  uniform  conditions  for 

the 

(63)  Member States that are not free or are not known to be free from listed diseases which 
are  subject  to  eradication  measures  as  provided  for  in  this  Regulation,  should  be 
required  to  establish  compulsory  eradication  programmes  to  eradicate  those  diseases 
where the eradication is compulsory in the Union, or have the possibility to establish 
voluntary eradication programmes, to eradicate those diseases where the eradication is 
envisaged  in  the  Union,  but  is  not  compulsory.  To  ensure  uniform  conditions  of 
general  application  throughout  the  Union,  it  is  necessary  to  lay  down  harmonised 
requirements  for  such  compulsory  or  voluntary  eradication  programmes.  In  order  to 
ensure effective disease eradication, the power to adopt acts in accordance with Article 
290 of the Treaty on the Functioning of the European Union should be delegated to the 
Commission in respect of the objectives of disease control strategies, disease control 
the  compulsory  or  voluntary  eradication  programmes  and 
measures  under 
requirements of such programmes. 

(64) 

In  order  to  ensure  uniform  conditions  for  the  implementation  of  disease  eradication 
programmes,  implementing  powers  should  be  conferred  on  the  Commission  to  lay 
down the procedures for the submission of such programmes, performance indicators, 
and reporting. 

(65)  Furthermore,  Member  States  should  have  the  possibility  of  declaring  the  whole  of 
their territories, zones or compartments thereof free of one or more of listed diseases, 
which  are  subject  to  rules  on  compulsory  or  voluntary  eradication  programmes,  in 
order to be protected against the introduction of such listed diseases from other parts 
of  the  Union  or  from  third  countries  or  territories.  A  clear  harmonised  procedure, 
including  the  necessary  criteria  for  disease-free  status,  should  be  established  for  that 
purpose.  In  order  to  ensure  uniform  conditions  for  the  implementation  of  the 
recognition of disease-free status within the Union it is necessary that such a disease-
free status is officially approved and thus implementing powers to approve such status 
should be conferred on the Commission. 

(66)  The OIE has introduced the concept of compartmentalisation in the framework of the 
Terrestrial  and  Aquatic  Animal  Health  Codes  (the  OIE  Codes).  In  Union  legislation 
adopted prior to this Regulation, that concept is only recognised for particular animal 
species  and  diseases,  specified  in  specific  Union  legislation,  namely  for  avian 
influenza and aquatic animal diseases. This Regulation should establish the possibility 
of using the compartment system for other animal species and diseases. In order to lay 
down  the  detailed  conditions  for  the  recognition,  rules  for  approval  and  the 
requirements  for  compartments,  the  power  to  adopt  acts  in  accordance  with  Article 
290 of the Treaty on the Functioning of the European Union should be delegated to the 
Commission. 

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20 

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(67)  Member  States  should  make  their  disease-free  territory,  zones  and  compartments 
thereof publicly known for the purpose of informing trading partners and facilitating 
trade.  

(68) 

In order to lay down the detailed conditions for the recognition of disease-free status, 
the  power  to  adopt  acts  in  accordance  with  Article  290  of  the  Treaty  on  the 
Functioning of the European Union should be delegated to the Commission in respect 
of the criteria  for obtaining such status, the evidence needed to substantiate freedom 
from  disease,  special  disease  prevention  and  control  measures,  restrictions, 
information  to  be  provided,  derogations,  and  conditions  for  the  maintenance, 
suspension, withdrawal or restoration of disease-free status. 

(69) 

In order to ensure uniform conditions for the implementation of procedures to obtain 
disease  free  status,  implementing  powers  should  be  conferred  on  the  Commission  to 
establish  the  listed  diseases  which  may  be  subject  to  compartmentalisation  and  lay 
down  detailed  rules  on  formats  for  the  submission  of  applications  and  information 
exchange. 

(70)  The presence of an entirely non-immune population of animals, susceptible to certain 
listed diseases, requires permanent disease awareness and preparedness. Contingency 
plans have proved to be a crucial tool for the successful control of disease emergencies 
in the past. In order to ensure this effective and efficient tool for the control of disease 
emergencies,  which  is  flexible  to  adjust  to  the  emergency  situations,  the  power  to 
adopt  acts  in  accordance  with  Article 290  of  the  Treaty  on  the  Functioning  of  the 
European  Union  should  be  delegated  to  the  Commission  in  respect  of  the  detailed 
requirements and conditions for contingency plans. 

(71)  Past animal health crises have shown the benefits of having specific, detailed and rapid 
management  procedures  for  disease  emergencies.  Those  organisational  procedures 
should ensure a rapid and effective response and improve coordination of efforts of all 
involved parties, and in particular the competent authorities and the stakeholders. 

(72)  To  ensure  the  applicability  of  contingency  plans  in  real  emergency  situations,  it  is 
essential  to  practise  and  test  that  the  systems  are  working.  For  that  purpose  the 
competent authorities of the Member States should carry out simulation exercises, in 
cooperation  with  the  competent  authorities  of  the  neighbouring  Member  States  and 
third countries and territories, where feasible and relevant. 

(73) 

In order to ensure uniform conditions for the implementation of contingency plans and 
simulation exercises, implementing powers should be conferred on the Commission to 
lay down rules for the practical implementation of those plans and exercises. 

(74)  Veterinary medicinal products such as vaccines, hyper immune sera and antimicrobials 
play an important role in the prevention and control of transmissible animal diseases. 
The Impact Assessment for the adoption of the EU Animal Health Law highlights in 
particular  the  importance  of  vaccines  as  a  tool  in  the  prevention,  control  and 
eradication of animal diseases.  

(75)  However, control strategies for some transmissible animal diseases require prohibition 
or  restriction  of  the  use  of  certain  veterinary  medicinal  products,  as  their  use  would 
hamper  the  effectiveness  of  those  strategies.  For  example,  hyper  immune  sera  or 
antimicrobial  agents  may  mask  the  expression  of  a  disease,  make  the  detection  of  a 

EN 

21 

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disease agent impossible or render a swift and differential diagnosis difficult and thus 
endanger the correct detection of disease. 

(76)  However,  those  control  strategies  may  substantially  vary  between  different  listed 
diseases.  Thus  this  Regulation  should  provide  for  rules  on  the  use  of  veterinary 
medicinal  products  for  the  prevention  and  control  of  listed  diseases  and  for 
harmonised criteria for consideration when determining whether or not to use and how 
to  use  vaccines,  hyper-immune  sera  and  antimicrobials.  In  order  to  ensure  a  flexible 
approach and to address the specificities of different listed diseases and the availability 
of the effective treatments, the power to adopt acts in accordance with Article 290 of 
the  Treaty  on  the  Functioning  of  the  European  Union  should  be  delegated  to  the 
Commission  in  respect  of  the  restrictions,  prohibitions  or  obligations  to  use  certain 
veterinary  medicinal  products  in  the  framework  of  the  control  of  certain  listed 
diseases. In the case of urgency and in order to address emerging risks with possible 
devastating implications for animal or public health, economy, society or environment, 
it should be possible for these measures to be adopted by the urgency procedure.  

(77)  Following  the  conclusions  of  the  Expert  opinion  on  vaccine  and/or  diagnostic  banks 
for  major  animal  diseases25  it  should  also  be  made  possible  for  the  Union  and  the 
Member States to establish reserves of antigens, vaccines and diagnostic reagents for 
listed  diseases  that  represent  a  serious  threat  for  animal  or  public  health.  The 
establishment of a Union antigen, vaccine and diagnostic reagent bank would promote 
the Union's animal health objectives by enabling a quick and effective response when 
its resources are required and represents an efficient use of limited resources.  

(78) 

In  order  to  ensure  such  a  quick  and  effective  response,  the  power  to  adopt  acts  in 
accordance with Article 290 of the Treaty on the Functioning of the European Union 
should  be  delegated  to  the  Commission,  in  respect  of  the  establishment  and  the 
management of such banks, and safety standards and requirements for the operation of 
those.  However, this Regulation should not provide for  the rules on the financing of 
the disease preventive and control measures, including vaccination. 

(79)  Criteria for priority access to the Union antigen, vaccine and diagnostic reagent banks' 
resources  should  be  established  in  order  to  ensure  their  effective  distribution  in 
emergencies.  

(80)  For reasons of security in relation to bio-terrorism and agro-terrorism, certain detailed 
information  concerning  the  Union  antigen,  vaccine  and  diagnostic  reagent  banks 
should be treated as classified information and its publication should be prohibited. 

(81) 

In  order  to  ensure  uniform  conditions  for  the  management  of  the  Union  antigen, 
vaccine  and  diagnostic  reagent  banks,  implementing  powers  should  be  conferred  on 
the Commission to lay down detailed rules concerning which biological products are 
to be included in those banks and for which diseases, and detailed rules on the supply, 
quantities,  storage,  delivery,  procedural  and  technical  requirements  for  vaccines, 
antigens  and  diagnostic  reagents  and  the  frequency  and  content  of  submissions  of 
information to the Commission. 

25 

Doc SANCO/7070/2010. 

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22 

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(82) 

In  the  event  of  an  outbreak  of  a  listed  disease  considered  to  represent  a  high  risk  to 
animal or public health in the Union, it is necessary to take immediate disease control 
measures  to  eradicate  that  listed  disease  in  order  to  protect  animal  and  public  health 
and the relevant sectors. 

(83)  Operators, animal professionals and pet keepers should have the primary responsibility 
for  controlling  and  preventing  the  spread  of  transmissible  animal  diseases.  They 
should take immediate action in case of suspicion or confirmation of highly contagious 
diseases.  

(84)  The competent authority should be responsible for initiating the first investigations to 
confirm  or  rule  out  an  outbreak  of  a  highly  contagious  listed  disease,  considered  to 
represent a high risk to animal or public health in the Union.  

(85)  The competent authority should put in place preliminary disease control measures to 
prevent  the  possible  spread  of  the  listed  disease  and  undertake  an  epidemiological 
enquiry. 

(86)  As  soon  as  a  listed  disease  is  confirmed  the  competent  authority  should  take  the 
necessary  disease  control  measures,  if  necessary  including  the  establishment  of 
restricted zones, to eradicate and prevent the further spread of that disease. 

(87)  The occurrence of a listed disease in wild animals may pose a risk to public health and 
the  health  of  kept  animals.  Special  rules  should  therefore  be  laid  down  for  disease 
control and eradication measures in wild animals where needed.  

(88)  For  listed  diseases,  which  are  not  highly  contagious,  and  which  are  subject  to 
compulsory  eradication,  the  disease  control  measures  should  be  implemented  to 
prevent  the  spread  of  those  listed  diseases,  in  particular  to  non-infected  areas. 
However,  those  measures  may  be  more  limited  or  different  comparing  to  those 
applicable  for  the  most  dangerous  listed  diseases.  This  Regulation  should  therefore 
provide  for  special  rules  for  those  diseases.  Member  States  that  have  a  voluntary 
eradication programme in place, should also implement such disease control measures. 
However, the level and intensity of disease control measures should be proportionate 
and  take  into  account  the  characteristics  of  the  listed  disease  in  question,  its 
distribution and its significance for the Member State concerned by it and the Union as 
a whole.  

(89) 

In  order  to  ensure  the  effective  application  of  the  disease  control  measures  provided 
for  in  this  Regulation  by  operators,  pet  keepers  and  the  competent  authorities  and 
taking into account the specificities of the disease control measures for particular listed 
diseases  and  the  risk  factors  involved,  the  power  to  adopt  acts  in  accordance  with 
Article  290  of  the  Treaty  on  the  Functioning  of  the  European  Union  should  be 
delegated to the Commission, in respect of the detailed disease control measures in the 
event of suspicion or confirmation of a listed disease in establishments, other locations 
and restricted zones. 

(90) 

In  order  to  provide  for  the  possibility  for  special  disease  control  measures  to  be 
adopted by the Commission on a temporary basis in the event that the disease control 
measures laid down in this Regulation are not sufficient or appropriate to address that 
risk,  implementing  powers  should  be  conferred  on  the  Commission  concerning  the 
laying down of special disease control measures for a limited period of time. 

EN 

23 

   EN 

(91)  The registration of certain transporters and establishments keeping terrestrial animals 
or  handling  germinal  products  or  transporting  them  is  necessary  to  allow  the 
competent  authorities  to  perform  adequate  surveillance  and  to  prevent,  control  and 
eradicate transmissible animal diseases.  

(92)  Where  a  certain  type  of  establishment  keeping  terrestrial  animals  or  handling  or 
storing germinal products poses a particular animal health risk, it should be subject to 
approval by the competent authority.  

(93)  To  avoid  unjustified  administrative  burdens  and  costs,  particularly  to  small  and 
medium size enterprises (SMEs), flexibility should be given to the Member States to 
adapt  the  system  of  registration  and  approval  to  local  and  regional  conditions  and 
production patterns. 

(94) 

In  the  interest  of  reducing  administrative  burdens,  registration  and  approvals  should, 
where  possible,  be  integrated  into  a  registration  or  approval  system  which  Member 
State may already have established for other purposes.  

(95)  Operators  have  first-hand  knowledge  of  the  animals  under  their  care.  They  should 
therefore maintain up-to-date records of information which are relevant for assessing 
the  animal  health  status,  for  traceability  and  for  an  epidemiological  enquiry  in  the 
event of the occurrence of a listed disease. Those records should be easily accessible to 
the competent authority.  

(96) 

In  order  to  ensure  the  public  availability  of  up-to-date  information  concerning  the 
registered establishments and transporters and approved establishments the competent 
authority should establish and keep a register of such establishments and transporters. 
The  power  to  adopt  acts  in  accordance  with  Article  290  of  the  Treaty  on  the 
Functioning of the European Union should be delegated to the Commission, in respect 
of  the  information  to  be  contained  in  the  register  of  establishments  and  transporters 
and  the  record  keeping  requirements,  as  regards  the  information  to  be  recorded, 
derogations  from  the  record  keeping  requirements  and  the  specific  additional 
requirements for germinal products. 

(97) 

In order to ensure uniform conditions for the implementation of the requirements laid 
down in this regulation on the registration and approval of establishments and on the 
record  keeping  and  registers,  implementing  powers  should  be  conferred  to  the 
Commission  to  lay  down  rules  concerning  the  information  obligations,  exemptions 
and other rules, the formats and operational specifications of the registers and records. 

(98)  Efficient  traceability  is  a  key  element  of  disease  control  policy.  Identification  and 
registration  requirements  specific  for  the  different  species  of  kept  terrestrial  animals 
and germinal products should be in place in order to facilitate the effective application 
of the disease prevention and control rules provided for in this regulation. In addition, 
it  is  important  to  provide  for  the  possibility  of  establishing  an  identification  and 
registration system for species for which such arrangements do not exist at present, or 
when changing circumstances and risks so warrant. 

(99) 

In  order  to  ensure  the  smooth  operation  of  the  identification  and  registration  system 
and ensure traceability, the power to adopt acts in accordance with Article 290 of the 
Treaty  on  the  Functioning  of  the  European  Union  should  be  delegated  to  the 
Commission,  in  respect  of  the  obligations  concerning  databases,  designation  of  the 

EN 

24 

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competent authority, detailed identification and registration requirements for different 
animal species and documents.  

(100)  It is appropriate to reduce administrative burdens and costs and provide for flexibility 
of the system in circumstances where the traceability requirements can be achieved by 
means other than those set out in this Regulation. The Commission should therefore be 
empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the 
Functioning of the European Union concerning the derogations from the identification 
and registration requirements. 

(101)  In order to ensure uniform conditions for the implementation of the identification and 
registration system and traceability, implementing powers should be conferred on the 
Commission  to  lay  down  rules  concerning  the  technical  specifications  for  databases, 
means  of  identification,  documents  and  formats,  the  deadlines,  and  criteria  for 
derogations from such systems. 

(102)  An important tool for preventing the introduction and spread of a transmissible animal 
disease  is  the  use  of  restrictions  on  movements  of  animals  and  products  that  may 
transmit that disease. However, restricting the movement of animals and products may 
have a severe economic impact and interfere with the operation of the internal market. 
Such restrictions should therefore only be applied where necessary and proportionate 
to the risks involved. This approach is in line with the principles laid down in the SPS 
Agreement and the OIE international standards. 

(103)  The  general  requirements  laid  down  in  this  Regulation  should  apply  to  all  animal 
movements,  such  as  the  prohibition  of  movement  of  animals  from  an  establishment 
where there are abnormal mortalities or other disease symptoms with an undetermined 
cause or disease prevention requirements during transport.  

(104)  The  legal  framework,  currently  laid  down  in  Union  legislation  for  the  movement  of 
terrestrial  animals  lays  down  harmonised  rules  primarily  for  the  movement  of 
terrestrial  animals  and  products  between  Member  States,  while  leaving  it  up  to  the 
Member  States  to  determine  the  necessary  movement  requirements  within  their 
territory.  A  comparison  of  the  current  situation  with  an  option  where  rules  for 
movements  within  Member  States  would  also  be  harmonised  at  Union  level,  was 
extensively elaborated in the Impact Assessment on the EU Animal Health Law. It has 
been  concluded  that  the  current  approach  should  be  maintained,  as  complete 
harmonisation of all movements would be very complex and the benefits in terms of 
the  facilitation  of  movements  between  Member  States  do  not  outweigh  the  negative 
impact this could have on the ability to control diseases.  

(105)  For  animals  that  are  moved  between  Member  States  a  set  of  basic  animal  health 
requirements apply. In particular, animals may not be moved from establishments with 
abnormal mortalities or signs of disease of unknown cause. However, mortalities, even 
if  abnormal,  which  are  linked  to  scientific  procedures  authorised  under  Directive 
2010/63/EU of the European Parliament and of the Council of 22 September 2010 on 
the protection of animals used for scientific purposes26 and which are not of infectious 
origin related to listed diseases, should not be a reason to prevent the movements of 
animals intended for scientific purposes.  

26 

OJ L 276, 20.10.2010, p. 33. 

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25 

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(106)  However, this Regulation should provide for flexibility to facilitate the movement of 
species and categories of terrestrial animals, which represent a low risk for spreading 
listed  diseases  between  Member  States.  In  addition,  further  possibilities  for 
derogations  should  be  provided  for  in  cases  where  Member  States  or  operators 
successfully  put  in  place  alternative  risk  mitigating  measures  such  as  high  levels  of 
biosecurity and effective surveillance systems. 

(107)  Ungulates and poultry are groups of animal species of high economic significance and 
are subject to specific movement requirements under Union legislation adopted prior 
to this Regulation, namely Council Directive 64/432/EEC of 26 June 1964 on animal 
health  problems  affecting  intra-Community  trade  in  bovine  animals  and  swine27, 
Council  Directive  91/68/EEC  of  28  January  1991  on  animal  health  conditions 
governing  intra-Community  trade  in  ovine  and  caprine  animals28,  Council  Directive 
2009/156/EC  of  30  November  2009  on  animal  health  conditions  governing  the 
movement  and  importation  from  third  countries  of  equidae29,  Council  Directive 
2009/158/EC  of  30  November  2009  on  animal  health  conditions  governing  intra-
Community trade in, and imports from third countries of, poultry and hatching eggs30 
and partially Council Directive 92/65/EEC of 13 July 1992 laying down animal health 
requirements governing trade in and imports into the Community of animals, semen, 
ova  and  embryos  not  subject  to  animal  health  requirements  laid  down  in  specific 
Community  rules  referred  to  in  Annex  A  (I)  to  Directive  90/425/EEC31.  The  main 
rules for the movement of those species should be laid down in this Regulation. The 
detailed requirements which largely depend on the diseases that may be transmitted by 
different  species  or  categories  of  animals  should  be  regulated  in  subsequent 
Commission  acts,  taking  into  account  the  specificities  of  the  diseases,  species  and 
categories of animals in question. 

(108)  As assembly operations for ungulates and poultry represent a particularly high disease 
risk, it is appropriate to lay down specific rules in this Regulation to protect the health 
of the animals involved and prevent the spread of transmissible animal diseases. 

(109)  Depending on the listed diseases and listed species, it is necessary to lay down specific 
animal  health  requirements  for  certain  animal  species  other  than  kept  ungulates  and 
poultry. Rules for these species were also laid down in the legal framework applicable 
prior to this Regulation and in particular in Directive 92/65/EEC. That Directive lays 
down specific movement rules for animal species including bees, bumble bees, apes, 
dogs  and  cats  etc.  and  this  Regulation  should  therefore  provide  a  legal  basis  for  the 
adoption of delegated and implementing acts laying down specific movement rules for 
those animal species.  

(110)  Confined  establishments,  usually  used  for  the  keeping  of  laboratory  animals  or  zoo 
animals, normally involve a high level of biosecurity, a favourable and well controlled 
health  status  and  are  subject  to  fewer  movements  or  movements  solely  within  the 
closed  circuits  of  those  establishments.  The  status  of  confined  establishments,  for 
which  the  operators  may  apply  for  on  a  voluntary  basis,  was  first  introduced  in 

27 
28 
29 
30 
31 

OJ 121, 29.7.1964, p. 1977. 
OJ L 46, 19.2.1991, p. 19. 
OJ L 192, 23.7.2010, p. 1. 
OJ L 343, 22.12.2009, p. 74. 
OJ L 268, 14.9.1992, p. 54. 

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26 

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Directive  92/65/EEC,  where  rules  and  requirements  for  approval  and  movement 
requirements  for  approved  bodies,  institutes  and  centres  are  laid  down.  That  system 
enables  those  establishments  to  exchange  animals  amongst  themselves  with  fewer 
movement requirements and at the same time providing health guarantees within the 
circuit  of  confined  establishments.  Therefore  it  has  been  broadly  accepted  by  the 
operators,  and  used  as  a  voluntary  option.  It  is  therefore  appropriate  to  preserve  the 
concept of confined establishments and also to lay down rules for movement between 
those establishments in this Regulation.  

(111)  For scientific purposes, such as research or diagnostic purposes, and in particular those 
authorised  in  accordance  with  Directive  2010/63/EU,  it  may  be  necessary  to  move 
animals which do not comply with the general animal health requirements laid down 
in  this  Regulation  and  represent  a  higher  animal  health  risk.  Those  kinds  of 
movements  should  not  be  prohibited  or  unduly  restricted  by  the  provisions  of  this 
Regulation,  as  this  could  impede  otherwise  authorised  research  activities  and  delay 
scientific  progress.  Nonetheless,  it  is  essential  that  rules  are  laid  down  in  this 
Regulation to ensure that movements of those animals take place in a safe manner. 

(112)  Movement  patterns  of  circus  animals,  animals  kept  in  zoos,  animals  intended  for 
exhibition and certain other animals often deviate from the movement patterns of other 
kept  species.  Specific  consideration  should  be  taken  in  adapting  Union  rules  on 
movement  to  such  animals,  taking  into  account  specific  risks  and  alternative  risk 
mitigation measures.  

(113)  In  order  to  ensure  that  the  objectives  of  recitals  102  to  112  of  this  Regulation  are 
achieved, the power to adopt acts in accordance with Article 290 of the Treaty on the 
Functioning  of  the  European  Union  should  be  delegated  to  the  Commission, 
concerning the disease preventive measures in transport, specific rules for movement 
of  certain  animal  species  and  special  circumstances,  such  as  assembly  operations  or 
rejected  consignments,  and  special  requirements  or  derogations  for  other  types  of 
movements, such as movement for scientific purposes. 

(114)  In order to ensure the possibility for special rules for movements, where the movement 
rules  are  not  sufficient  or  appropriate  to  limit  the  spread  of  a  certain  disease, 
implementing  powers  should  be  conferred  on  the  Commission  to  lay  down  special 
movement rules for a limited period of time. 

(115)  Kept  terrestrial  animals  that  are  moved  between  Member  States  should  comply  with 
the requirements for such movements. In the case of species presenting a health risk 
and of greater economic importance, they should be accompanied by an animal health 
certificate issued by the competent authority. 

(116)  To 

the  extent 

technically,  practically  and  financially  feasible, 

technological 
developments should be availed of to reduce the administrative burdens on operators 
and  the  competent  authority  in  relation  to  certification  and  notification  by  using 
information technology to replace the paper documentation and facilitate notification 
procedures and using them as far as possible for multiple purposes.  

(117)  In  cases  where  an  animal  health  certificate  issued  by  the  competent  authority  is  not 
required, an operator who moves animals to another Member State should issue a self-

EN 

27 

   EN 

declaration  document  which  confirms  that  the  animals  meet  the  movement 
requirements laid down in this Regulation.  

(118)  In order to ensure the achievement of the objectives referred to in recitals 115, 116 and 
117 of this Regulation the powers to adopt acts in accordance with Article 290 of the 
Treaty  on  the  Functioning  of  the  European  Union  should  be  delegated  to  the 
Commission,  concerning  rules  on 
information  obligations,  and 
derogations  from  the  animal  health  certification  requirements,  specific  certification 
rules and the obligations of official veterinarians to conduct appropriate checks before 
the signing the animal health certificate.  

the  content, 

(119)  Notification of movements of animals and germinal products between Member States 
and  in  some  cases  within  the  national  territories  of  Member  States  is  essential  to 
ensure  traceability  of  animals  and  those  germinal  products,  where  these  movements 
may  be  linked  to  a  risk  of  spreading  transmissible  animal  diseases.  Therefore,  such 
movements  should  be  notified  and  registered.  The  IMSOC  system  provided  for  in 
Article 130(1) of the Regulation (EU) No xxx/xxx of the European Parliament and of 
the  Council  on  official  controls  and  other  official  activities  performed  to  ensure  the 
application of food and feed law, rules on animal health and welfare, plant health and 
plant reproductive material, plant protection products and amending Regulations (EC) 
No  999/2001,  1829/2003,  1831/2003,  1/2005,  396/2005,  834/2007,  1099/2009, 
1069/2009,  1107/2009,  Regulations  (EU)  No  1151/2012,  [….]/2013,  and  Directives 
98/58/EC,  1999/74/EC,  2007/43/EC,  2008/119/EC,  2008/120/EC  and  2009/128/EC 
(Official controls Regulation)32 [Publication office] should be used for that purpose. 

(120)  In order to ensure uniform conditions for the implementation of the rules laid down in 
this  Regulation  on  animal  health  certification  and  movement  notification, 
implementing  powers  should  be  conferred  on  the  Commission  to  lay  down  rules 
concerning  the  model  animal  health  certificates,  self-declaration  documents,  formats 
and  deadlines  for  movement  notification  for  both  terrestrial  and  aquatic  animals, 
germinal products and where also relevant, products of animal origin.  

(121)  The  specific  nature  of  movements  of  pet  animals  represents  an  animal  health  risk 
which  deviates  significantly  from  that  of  other  kept  animals.  Specific  rules  for  such 
movements  should  therefore  be  laid  down  in  this  Regulation.  In  order  to  ensure  that 
pet  animals  do  not  pose  a  significant  risk  for  the  spread  of  transmissible  animal 
diseases, the power to adopt acts in accordance with Article 290 of the Treaty on the 
Functioning of the European Union should be delegated to the Commission in respect 
of  the  detailed  rules  for  movements  of  those  animals.  In  order  to  ensure  uniform 
conditions for the implementation of the animal health requirements laid down in this 
Regulation concerning the movements of pet animals, implementing powers should be 
conferred on the Commission to lay down rules concerning the disease prevention and 
control measures to be taken for such movements.  

(122)  Wild animals may for various reasons represent an animal and public health risk, for 
example, if they are moved into an establishment or from one environment to another 
environment.  Appropriate  preventive  measures  for  movement  of  those  animals  may 
need  to  be  taken  to  avoid  the  spread  of  transmissible  animal  diseases.  In  order  to 

32 

OJ L … 

EN 

28 

   EN 

                                                 
ensure that wild animals do not pose a significant risk for the spread of transmissible 
animal diseases the power to adopt acts in accordance with Article 290 of the Treaty 
on  the  Functioning  of  the  European  Union  should  be  delegated  to  the  Commission, 
concerning the additional requirements for movements of wild terrestrial animals. 

(123)  Germinal  products  can  represent  a  similar  risk  of  spreading  transmissible  animal 
diseases to live animals. In addition, there are specificities in their production, which 
are related to high health demands for breeding animals and which call for stricter or 
particular animal health requirements concerning the donor animals. In order to ensure 
safe movements of germinal products, their expected high health standard and to take 
into  account  some  specific  uses,  the  power  to  adopt  acts  in  accordance  with  Article 
290 of the Treaty on the Functioning of the European Union should be delegated to the 
Commission, concerning the detailed requirements for movement of germinal products 
of  certain  animal  species,  special  requirements,  such  as  for  example  their  movement 
for scientific purposes, and derogations from the animal health certification obligation.  

(124)  Products of animal origin can represent a risk for the spreading of transmissible animal 
diseases. Food safety requirements for products of animal origin laid down in Union 
legislation  ensure  good  hygiene  practices  and  reduce  the  animal  health  risks  of  such 
products. However, for certain cases specific animal health measures, such as disease 
control and emergency measures should be laid down in this Regulation to ensure that 
products  of  animal  origin  do  not  spread  animal  diseases.  In  order  to  ensure  safe 
movements of products of animal origin in these particular cases, the power to adopt 
acts in accordance with Article 290 of the Treaty on the Functioning of the European 
Union  should  be  delegated  to  the  Commission,  concerning  detailed  rules  for 
movements of products of animal origin in relation to disease control measures taken, 
the obligations for animal health certification and derogations from those rules, where 
the  risk  involved  with  such  movements  and  the  risk  mitigating  measures  in  place 
permit so. .  

(125)  When  Member  States  take  national  measures  concerning  movements  of  animals  and 
germinal  products  or  decide  to  take  national  measures  to  limit  the  impact  of 
transmissible  animal  diseases  other  than  listed  diseases  within  their  territory,  those 
national measures should not interfere with the rules on the internal market laid down 
in Union legislation. Therefore, it is appropriate to set the framework for such national 
measures and ensure that they remain within the limits permitted under Union law.  

(126)  The registration and approval of aquaculture establishments is necessary to allow the 
competent  authorities  to  perform  adequate  surveillance  and  to  prevent,  control  and 
eradicate 
requires  all 
establishments  which  move  aquatic  animals  to  be  authorised.  That  system  of 
authorisation  should  be  maintained  under  this  Regulation,  notwithstanding  that  fact 
that  in  some  official  EU  languages,  different  terms  are  used  for  this  system  of 
authorisation in this Regulation as compared to Directive 2006/88/EC. 

transmissible  animal  diseases.  Directive  2006/88/EC 

(127)  The  slaughter  and  processing  of  aquaculture  animals  which  are  subject  to  disease 
control measures may spread transmissible animal disease, for example as a result of 
effluents containing pathogens being discharged from processing establishments. It is 
therefore  necessary  to  approve  processing  establishments  which  fulfil  the  risk 
mitigation  measures  to  undertake  such  slaughter  and  processing.  Therefore,  this 

EN 

29 

   EN 

Regulation  should  provide  for  the  approval  of  disease  control  aquatic  food 
establishments. 

(128)  In  order  to  ensure  the  public  availability  of  up-to-date  information  concerning 
registered  and  approved  establishments  the  competent  authority  should  establish  and 
keep  such  a  register.  The  power  to  adopt  acts  in  accordance  with  Article  290  of  the 
Treaty  on  the  Functioning  of  the  European  Union  should  be  delegated  to  the 
Commission,  concerning  the  information  to  be  included  in  register  of  aquaculture 
establishments  and  the  record  keeping  requirements  for  aquaculture  establishments 
and transporters. 

(129)  In order to ensure uniform conditions for the implementation of the rules laid down in 
this  Regulation  for  the  registration  and  approval  of  aquaculture  establishments  and 
disease  control  aquatic  food  establishments,  record  keeping  and  registers  of 
establishments,  implementing  powers  should  be  conferred  on  the  Commission  to  lay 
down 
information  obligations,  derogations  and  other 
implementing rules, and the format and operational specifications of the registers and 
records. 

rules  concerning 

the 

(130)  As it is not feasible in most cases to individually identify aquatic animals, the keeping 
of  records  at  aquaculture  establishments,  disease  control  aquatic  food  establishments 
and by transporters is an essential tool in ensuring the traceability of aquatic animals. 
Records are also valuable for the surveillance of the health situation of establishments. 

(131)  Similarly  to  terrestrial  animals,  it  is  necessary  to  lay  down  harmonised  rules  on  the 
movement  of  aquatic  animals,  including  rules  on  animal  health  certification  and 
movement notification.  

(132)  Directive 2006/88/EC lays down rules for movements of aquatic animals, which apply 
equally to movements within and between Member States. The key determining factor 
for  movement  rules  for  aquatic  animals  is  the  health  status  as  regards  the  listed 
diseases of the Member State, zones and compartments of destination. 

(133)  The  same  system  should  also  be  provided  for  in  this  Regulation.  However,  to 
encourage  Member  States  to  enhance  the  health  status  of  their  aquatic  populations, 
some adjustments and added flexibility should be introduced.  

(134)  In  order  to  ensure  movement  control  for  aquatic  animals,  the  power  to  adopt  acts  in 
accordance with Article 290 of the Treaty on the Functioning of the European Union 
should  be  delegated  to  the  Commission,  concerning  the  disease  preventive  measures 
applicable  to  transport,  specific  rules  for  movements  of  certain  categories  of  aquatic 
animals for different purposes, specific requirements or derogations for certain types 
of movements, such as movement for scientific purposes and additional requirements 
for movement of wild aquatic animals. 

(135)  In order to ensure the possibility of temporary derogations and specific requirements 
for  movements  of  aquatic  animals,  where  the  movement  rules  laid  down  in  this 
Regulation  are  not  sufficient  or  appropriate  to  limit  the  spread  of  a  certain  listed 
disease,  implementing  powers  should  be  conferred  on  the  Commission  for  laying 
down special movement rules or derogations for a limited period of time. 

EN 

30 

   EN 

(136)  Union aquaculture production is extremely diverse as regards species and production 
systems  and  this  diversification  is  rapidly  increasing.  This  may  warrant  that  national 
measures  concerning  diseases  other  than  those  that  are  regarded  as  listed  diseases  in 
accordance  with  this  Regulation  are  taken  at  Member  State  level.  However,  such 
national  measures  should  be  justified, necessary and proportionate to the goals to be 
achieved.  Furthermore,  they  should  not  affect  movements  between  Member  States 
unless it is necessary in order to prevent the introduction of or to control the spread of 
disease. National measures affecting trade between Member States should be approved 
and regularly reviewed at Union level. 

(137)  Currently, listed diseases concern animal species other than those defined as terrestrial 
and aquatic by this Regulation, such as reptiles, amphibians, insects and others only to 
a very limited extent. It is therefore not appropriate to require that all the provisions of 
this Regulation apply to those animals. However, if a disease which concerns species 
other  than  terrestrial  and  aquatic  should  become  listed,  the  relevant  animal  health 
requirements of this Regulation should apply to those species to ensure that adequate 
and proportionate disease prevention and control measures may be taken. 

(138)  In order to ensure the possibility of laying down movement rules for those animals that 
are  not  defined  as  terrestrial  and  aquatic  animals  by  this  Regulation,  and  germinal 
products and products of animal origin from them, when a risk so warrants, the power 
to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the 
European  Union  should  be  delegated  to  the  Commission,  concerning  the  registration 
and  approval  of  establishments,  record  keeping  and  registers,  identification  and 
registration  and  traceability  movement  requirements,  animal  health  certification  and 
self-declaration and movement notification obligations for animals, germinal products 
and products of animal origin of those species.  

(139)  When  necessary  to  ensure  uniform  conditions  for  the  implementation  of  the  animal 
health requirements for those other animal species and germinal products and products 
of  animal  origin  from  them,  implementing  powers  should  be  conferred  on  the 
Commission to lay down detailed rules concerning those requirements.  

(140)  To prevent the introduction of listed diseases and emerging diseases into the Union, it 
is  necessary  to  have  in  place  efficient  rules  on  the  entry  into  the  Union  of  animals, 
germinal products and products of animal origin that may transmit such diseases.  

(141)  The requirements for entry of animals and products into the Union should mirror the 
requirements for movements of animal and products of the same category, species and 
intended use within the Union. 

(142)  To  ensure  that  animals,  germinal  products  and  products  of  animal  origin  from  third 
countries  or  territories  comply  with  the  animal  health  requirements  that  provide 
guarantees that are equivalent to those provided for in Union legislation, it is essential 
that  they  are  subject  to  appropriate  controls  by  the  competent  authority  of  the  third 
countries or territories exporting to the Union. Where relevant, the  health status  of a 
third  country  or  territory  of  origin  should  be  verified  prior  to  accepting  the  entry  of 
such  animals,  germinal  products  and  products  of  animal  origin.  Consequently,  only 
third countries and territories which can demonstrate that they meet the animal health 
standards  for  entry  of  the  animals  and  products  into  the  Union  should  be  eligible  to 
export them to the Union and be listed for that purpose.  

EN 

31 

   EN 

(143)  For some species and categories of animals, germinal products and products of animal 
origin the Union lists of third countries and territories from which entry into the Union 
is  permitted  have  not  been  established  in  Union  acts  adopted  prior  to  the  date  of 
adoption of this Regulation. In those cases and pending the adoption of rules pursuant 
to Regulation, Member States should be permitted to determine from which countries 
and territories those animals, germinal products and products of animal origin may be 
permitted  to  enter  their  territory.  In  so  determining,  Member  States  should  take  into 
account the criteria laid down in this Regulation for the Union lists of third countries 
and territories. 

(144)  To ensure that the animal health requirements for the entry into the Union provided for 
in  this  Regulation  are  complied  with  and  are  in  line  with  the  principles  of  the  OIE 
Animal  Health  Codes,  all  animals,  germinal  products  and  products  of  animal  origin 
entering  the  Union  should  be  accompanied  by  an  animal  health  certificate  issued  by 
the competent authority  of the third  country  or territory of origin confirming  that all 
the animal health requirements for entry into the Union are complied with. However, 
deviation from this rule for commodities which pose a low animal health risk should 
be permitted.  

(145)  Animal health certificates may stand on their own, but certification is often required in 
Union  legislation  for  other  purposes,  for  example  to  certify  that  public  health  or 
animal welfare requirements of animals or products have been complied with. This has 
to be taken into account. In order to minimise administrative burdens and costs those 
animal  health  certificates  should  also  be  permitted  to  include  information  required 
under other Union food and feed safety legislation. 

(146)  Diseases may be spread by means other than animals, germinal products, products of 
animal  origin  and  animal  by-products  and  derived  products.  For  instance,  vehicles, 
transport  containers,  hay,  straw,  plant  products,  materials  that  may  have  been  in 
contact  with  infected  animals  and  equipment  may  also  spread  disease.  Where 
necessary, measures should be taken to prevent these routes of disease transmission by 
those means.  

(147)  In order to ensure the appropriate level of detail for the requirements for entry into the 
Union,  the  power  to  adopt  acts  in  accordance  with  Article  290  of  the  Treaty  on  the 
Functioning  of  the  European  Union  should  be  delegated  to  the  Commission,  to 
supplement  and  amend  the  criteria  for  the  listing  of  third  countries  and  territories, 
criteria for the suspension or withdrawal from that list, supplementing the rules for the 
approval  of  establishments  in  third  countries  and  territories  and  derogations,  animal 
health requirements for the entry into the Union of consignments from third countries 
and  territories,  contents  of  animal  health  certificates,  and  the  animal  health 
requirements  for  disease  agents,  other  materials,  means  of  transport  and  equipment, 
which may transmit animal diseases. 

(148)  In  order  to  ensure  uniform  conditions  for  the  implementation  of  the  animal  health 
requirements  for  the  entry  into  the  Union  of  consignments  of  animals,  germinal 
products and products of animal origin, implementing powers should be conferred on 
the  Commission  to  lay  down  rules  on,  inter  alia  the  list  of  third  countries  and 
territories  from  which  the  entry  into  the  Union  of  animals,  germinal  products  and 
products of animal origin is allowed and model animal health certificates. 

EN 

32 

   EN 

(149)  Past  experience  has  shown  that  when  an  outbreak  of  a  serious  disease  occurs  in 
Member States or in third countries or territories from which animals or products enter 
the Union, disease prevention and control measures have to be taken immediately to 
limit  its  introduction  and  spread.  Such  an  emergency  may  involve  listed  diseases, 
emerging  diseases  or  other  animal  health  hazards.  In  that  context,  it  should  be  made 
clear  which  sets  of  disease  prevention  and  control  measures  laid  down  in  this 
Regulation may be used in the event of the occurrence of a listed or emerging disease 
or  hazard.  In  all  these  cases  it  is  essential  that  measures  can  be  taken  at  very  short 
notice  and  without  any  delay.  As  such  measures  would  restrict  movement  within  or 
into the Union they should be implemented at Union level whenever possible.  

(150)  In  order  to  ensure  an  effective  and  quick  reaction  to  emerging  risks,  implementing 

powers should be conferred on the Commission to lay down emergency measures. 

(151)  The  Commission  should  adopt  immediately  applicable  implementing  acts  in  duly 
justified  cases  relating  to  inter  alia  the  listing  of  diseases  and  species,  the  listed 
diseases that are to be subject to the sets of disease prevention and control rules, the 
stocking, supply, storage, delivery and other procedures of Union antigen, vaccine and 
diagnostic  reagent  banks,  the  laying  down  of  special  disease  control  measures  and 
derogations for a limited period of time, the special movement rules for terrestrial and 
aquatic animals for a limited period of time, the emergency measures, and the listing 
of third countries and territories for entry into the Union. 

(152)  This Regulation lays down general and specific rules for the prevention and control of 
transmissible  animal  diseases  and  ensures  a  harmonised  approach  to  animal  health 
across  the  Union.  In  some  areas,  such  as  general  responsibilities  for  animal  health, 
notification, surveillance, registration and approval or traceability, the Member States 
should  be  allowed  or  encouraged  to  apply  additional  or  more  stringent  national 
measures.  However,  such  national  measures  should  be  permitted  only  if  they  do  not 
compromise  the  animal  health  objectives  of  this  Regulation,  and  if  they  are  not  in 
contradiction  with  the  rules  laid  down  therein  and  provided  that  they  do  not  hinder 
movements of animals and products between Member States, unless it is necessary in 
order to prevent the introduction of or to control the spread of disease.  

(153)  The  national  measures  referred  to  in  recital  152  should  be  subject  to  a  simplified 
notification  procedure  in  order  to  reduce  the  administrative  burden.  Experience  has 
shown that the general notification procedure laid down in Directive 98/34/EC of the 
European Parliament and of the Council of 22 June 1998 laying down a procedure for 
the provision of information in the field of technical standards and regulations and of 
rules  on  Information  Society  services33,  has  been  an  important  tool  for  guiding  and 
improving  the  quality  of  national  technical  regulations  –  in  terms  of  increased 
transparency,  readibility  and  effectiveness,  in  non-harmonised  or  partly  harmonised 
areas. It is therefore appropriate that this general notification procedure laid down in 
Directive 98/34/EC applies. 

(154)  Currently,  Union  rules  on  animal  health  are  laid  down  in  the  following  acts  of  the 
European Parliament and of the Council and in subsequent Commission acts adopted 
pursuant to them:  

33 

OJ L 204, 21.7.1998, p. 37. 

EN 

33 

   EN 

                                                 
– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

Council  Directive  64/432/EEC  of  26  June  1964  on  animal  health  problems 
affecting intra-Community trade in bovine animals and swine34,  

Council  Directive  77/391/EEC  of  17  May  1977  introducing  Community 
measures for the eradication of brucellosis, tuberculosis and leucosis in cattle35,  

Council  Directive  78/52/EEC  of  13  December  1977  establishing 
the 
Community  criteria  for  national  plans  for  the  accelerated  eradication  of 
brucellosis, tuberculosis and enzootic leukosis in cattle36,  

Council Directive 88/407/EEC of 14 June 1988 laying down the animal health 
requirements applicable to intra-Community trade in and imports of semen of 
domestic animals of the bovine species37,  

Council Directive 80/1095/EEC of 11 November 1980 laying down conditions 
designed to render and keep the territory of the Community free from classical 
swine fever38,  

Council  Directive  82/894/EEC  of  21  December  1982  on  the  notification  of 
animal diseases within the Community39,  

Council  Directive  89/556/EEC  of  25  September  1989  on  animal  health 
conditions  governing  intra-Community  trade  in  and  importation  from  third 
countries of embryos of domestic animals of the bovine species40,  

Council Directive 90/429/EEC of 26 June 1990 laying down the animal health 
requirements applicable to intra- Community trade in and imports of semen of 
domestic animals of the porcine species41, 

Council Directive 91/68/EEC of 28 January 1991 on animal health conditions 
governing intra-Community trade in ovine and caprine animals42,  

Council Decision 91/666/ EEC of 11 December 1991 establishing Community 
reserves of foot-and-mouth disease vaccines43,  

Council Directive 92/35/EEC of 29 April 1992 laying down control rules and 
measures to combat African horse sickness44,  

Council  Directive  92/65/EEC  of  13  July  1992  laying  down  animal  health 
requirements  governing  trade  in  and  imports  into  the  Community  of  animals, 
semen, ova and embryos not subject to animal health requirements laid down 

34 
35 
36 
37 
38 
39 
40 
41 
42 
43 
44 

OJ 121, 29.7.1964, p. 1977. 
OJ L 145, 13.6.1977, p. 44. 
OJ L 15, 19.1.1978, p. 34. 
OJ L 194, 22.7.1988, p. 10. 
OJ L 325, 1.12.1980, p. 1. 
OJ L 378, 31.12.1982, p. 58. 
OJ L 302, 19.10.1989, p. 1. 
OJ L 224, 18.8.1990, p. 62. 
OJ L 46, 19.2.1991, p. 19. 
OJ L 368, 31.12.1991, p. 21. 
OJ L 157, 10.6.1992, p. 19. 

EN 

34 

   EN 

                                                 
in  specific  Community  rules  referred  to  in  Annex  A  (I)  to  Directive 
90/425/EEC45,  

Council  Directive  92/66/EEC  of  14  July  1992  introducing  Community 
measures for the control of Newcastle disease46,  

Council  Directive  92/118/EEC  of  17  December  1992  laying  down  animal 
health and public health requirements governing trade in and imports into the 
Community  of  products  not  subject  to  the  said  requirements  laid  down  in 
specific Community rules referred to in Annex A (I) to Directive 89/662/EEC 
and, as regards pathogens, to Directive 90/425/EEC47,  

Council  Directive  92/119/EEC  of  17  December  1992  introducing  general 
Community  measures  for  the  control  of  certain  animal  diseases  and  specific 
measures relating to swine vesicular disease48,  

Council Decision 95/410/EC of 22 June 1995 laying down the rules for testing 
by sampling in the establishment of origin of poultry for slaughter intended for 
Finland and Sweden49, 

Council  Directive  2000/75/EC  of  20  November  2000  laying  down  specific 
provisions for the control and eradication of bluetongue50,  

Council  Decision  2000/258/EC  of  20  March  2000  designating  a  specific 
institute responsible for establishing the criteria necessary for standardising the 
serological tests to monitor the effectiveness of rabies vaccines51, 

Regulation (EC) No 1760/2000 of the European Parliament and of the Council 
of 17 July 2000 establishing a system for the identification and registration of 
bovine  animals  and  regarding  the  labelling  of  beef  and  beef  products  and 
repealing Council Regulation (EC) No 820/9752,  

Council  Directive  2001/89/EC  of  23  October  2001  on  Community  measures 
for the control of classical swine fever53,  

Council Directive 2002/60/EC of 27 June 2002 laying down specific provisions 
for the control of African swine fever and amending Directive 92/119/EEC as 
regards Teschen disease and African swine fever54,  

– 

– 

– 

– 

– 

– 

– 

– 

– 

45 
46 
47 
48 
49 
50 
51 
52 
53 
54 

OJ L 268, 14.9.1992, p. 54. 
OJ L 260, 5.9.1992, p. 1. 
OJ L 62, 15.3.1993, p. 49. 
OJ L 62, 15.3.1993, p. 69. 
OJ L 243, 11.10.1995, p. 25. 
OJ L 327, 22.12.2000, p. 74. 
OJ L 79, 30.3.2000, p. 40.  
OJ L 204, 11.8.2000, p. 1. 
OJ L 316, 1.12.2001, p. 5. 
OJ L 192, 20.7.2002, p. 27. 

EN 

35 

   EN 

                                                 
– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

Council  Directive  2002/99/EC  of  16  December  2002  laying  down  the  animal 
health rules governing the production, processing, distribution and introduction 
of products of animal origin for human consumption55,  

Council  Directive  2003/85/EC  of  29  of  September  2003  on  Community 
measures  for  the  control  of  foot-and-mouth  disease  repealing  Directive 
85/511/EEC  and  Decisions  89/531/EEC  and  91/665/EEC  and  amending 
Directive 92/46/EEC56,  

Regulation  (EU)  No  XXX/XXXX  of  the  European  Parliament  and  of  the 
Council of …. on the non-commercial movement of pet animals and repealing 
Regulation (EC) No 998/2003 [Publication office] 57,  

Council  Regulation  (EC)  No  21/2004  of  17  December  2003  establishing  a 
system for the identification and registration of ovine and caprine animals and 
amending  Regulation  (EC)  No  1782/2003  and  Directives  92/102/EEC  and 
64/432/EEC/EEC58,  

Council  Directive  2004/68/EC  of  26  April  2004  laying  down  animal  health 
rules for the importation into and transit through the Community of certain live 
ungulate  animals,  amending  Directives  90/426/EEC  and  92/65/EEC  and 
repealing Directive 72/462/EEC59,  

Council  Directive  2009/156/EC  of  30  November  2009  on  animal  health 
conditions  governing  the  movement  and  importation  from  third  countries  of 
equidae60,  

Council Directive 2005/94/EC of 20 December 2005 on Community measures 
for the control of avian influenza and repealing Directive 92/40/EEC61,  

Council  Directive  2006/88/EC  of  24  October  2006  on  animal  health 
requirements  for  aquaculture  animals  and  products  thereof,  and  on  the 
prevention and control of certain diseases in aquatic animals62,  

Council  Directive  2008/71/EEC  of  15  July  2008  on  the  identification  and 
registration of pigs (codifying Directive 92/102/EEC)63,  

Council  Directive  2009/158/EC  of  30  November  2009  on  animal  health 
conditions  governing  intra-Community  trade  in,  and  imports  from  third 
countries of, poultry and hatching eggs64.  

55 
56 
57 
58 
59 
60 
61 
62 
63 
64 

OJ L 18, 23.1.2003, p. 11. 
OJ L 306, 22.11.2003, p. 1. 
OJ L … 
OJ L 5, 9.1.2004, p. 8. 
OJ L 139, 30.4.2004, p. 321. 
OJ L 192, 23.7.2010, p. 1. 
OJ L 10, 14.1.2006, p. 16. 
OJ L 328, 24.11.2006, p. 14. 
OJ L 213, 8.8.2008, p. 31. 
OJ L 343, 22.12.2009, p. 74. 

EN 

36 

   EN 

                                                 
(155)  The rules laid down in the legislative acts referred to in recital 154 are to be replaced 
by this Regulation and by subsequent Commission acts to be adopted pursuant to this 
Regulation. Accordingly, those legislative acts should be repealed. However, to ensure 
legal  clarity  and  avoid  a  legal  vacuum,  the  repeal  should  only  take  effect  when  the 
relevant delegated and implementing acts are adopted pursuant to this Regulation. It is 
therefore  necessary  to  provide  the  Commission  with  the  empowerment  to  determine 
the dates when the repeal of those legislative acts should take effect.  

(156)  The  following  Council  acts  in  the  area  of  animal  health  are  obsolete  and  should  be 
expressly  repealed  in  the  interests  of  clarity  of  Union  legislation:  Council  Decision 
78/642/EEC of 25 July 1978 on health protection measures in respect of the Republic 
of  Botswana65;  Council  Directive  79/110/EEC  of  24  January  1979  authorizing  the 
Italian Republic to postpone the notification and implementation of its national plans 
for  the  accelerated  eradication  of  brucellosis  and  tuberculosis  in  cattle66;  Council 
Directive  81/6/EEC  of  1 January  1981  authorizing  the  Hellenic  Republic  to 
communicate  and  to  implement  its  national  plans  for  the  accelerated  eradication  of 
brucellosis and tuberculosis in cattle67; Council Decision 89/455/EEC of 24 July 1989 
introducing Community measures to set up pilot projects for the control of rabies with 
a  view  to  its  eradication  or  prevention68;  Council  Directive  90/423/EEC  of  26  June 
1990  amending  Directive  85/511/EEC  introducing  Community  measures  for  the 
control  of  foot-and-mouth  disease69;  Council  Decision  90/678/EEC  of  13  December 
1990  recognizing  certain  parts  of  the  territory  of  the  Community  as  being  either 
officially swine fever free or swine fever free70. 

(157)  The  requirements  of  this  Regulation  should  not  apply  until  all  the  delegated  and 
implementing acts to be adopted by the Commission pursuant to this Regulation, have 
applied. It is appropriate to provide for at least 36 months to elapse between the date 
of entry into force of this Regulation and the date of application of the new rules, to 
allow the operators affected sufficient time to adapt. 

(158)  In order to ensure legal certainty as regards the application of rules for identification 
and  registration  of  animals,  disease  control  measures  for  certain  zoonoses  and  non-
commercial  movements  of  pet  animals,  the  power  to  adopt  acts  in  accordance  with 
Article  290  of  the  Treaty  on  the  Functioning  of  the  European  Union  should  be 
delegated  to  the  Commission  in  respect  of  the  date  on  which  Regulations  (EC)  No 
1760/2000, (EU) No XXX/XXX [Ex-998/2003] and (EC) No 21/2004 and Directives 
92/66/EEC,  2000/75/EC,  2001/89/EC,  2002/60/EC,  2003/85/EC,  2005/94/EC  and 
2008/71/EC cease to apply. 

(159)  The  implementing  powers  provided  for  in  this  Regulation  should  be  exercised  in 
accordance with Regulation (EU) No 182/2011 of the European Parliament and of the 
Council of 16 February 2011 laying down the rules and general principles concerning 

65 
66 
67 
68 
69 
70 

OJ L 213, 3.8.1978, p. 15. 
OJ L 29, 3.2.1979, p. 24. 
OJ L 14, 16.1.1981, p. 22. 
OJ L 223, 2.8.1989, p. 19. 
OJ L 224, 18.8.1990, p. 13. 
OJ L 373, 31.12.1990, 29. 

EN 

37 

   EN 

                                                 
mechanisms  for  control  by  the  Member  States  of  the  Commission's  exercise  of 
implementing powers71. 

(160)  It is of particular importance that the Commission carry out appropriate consultations 
during  its  preparatory  work,  including  at  expert  level.  The  Commission,  when 
preparing  and  drawing  up  delegated  acts,  should  ensure  a  simultaneous,  timely  and 
appropriate transmission of relevant documents to the European Parliament and to the 
Council. 

(161)  This  Regulation  should  not  create  a  disproportionate  administrative  burden  or 
economic  impact  for  small  and  medium  sized  enterprises.  Under  this  Regulation, 
based  on  consultation  with  stakeholders,  the  special  situation  of  small  and  medium 
sized  enterprises  has  been  taken  into  account.  A  potential  universal  derogation  from 
the  requirements  of  this  Regulation  for  such  enterprises  has  not  been  considered,  in 
view  of  the  public  policy  objectives  to  protect  animal  health  and  public  health. 
However,  a  number  of  derogations  for  such  enterprises  should  be  provided  for  in 
relation to the different requirements of this Regulation, taking into account the risks 
involved.  

(162)  The objectives of this Regulation, namely to lay down animal health rules for animals, 
germinal products, products of animal origin, animal by-products and derived products 
to the extent that they are not covered by specific rules in other Union legislation and 
other  material  that  can  be  involved  in  the  spread  of  transmissible  animal  diseases, 
cannot  be  achieved  sufficiently  by  the  Member  States,  and  can  be  more  efficiently 
achieved  at  Union  level  through  a  common  and  coordinated  legal  framework  for 
animal health. This Regulation is therefore in line with the principle of subsidiarity as 
set  out  in  Article  5(3)  of  the  Treaty  on  European  Union.  In  accordance  with  the 
principle  of  proportionality,  as  set  out  in  that  Article,  this  Regulation  does  not  go 
beyond what is necessary in order to achieve those objectives, 

HAVE ADOPTED THIS REGULATION: 

PART I  
GENERAL RULES 

Chapter 1 
Subject matter, scope and definitions  

Article 1 
Subject matter 

1. 

This  Regulation  lays  down  rules  for  the  prevention  and  control  of  animal  diseases, 
which are transmissible to animals or to humans. 

Those rules provide for:  

71 

OJ L 55, 28.2.2011, p. 13. 

EN 

38 

   EN 

                                                 
(a) 

(b) 

the  prioritisation  and  categorisation  of  diseases  of  Union  concern  and  for 
establishing responsibilities for animal health in Part I; 

the  early  detection,  notification  and  reporting  of  diseases,  surveillance, 
eradication programmes and disease-free status in Part II; 

(c) 

disease awareness, preparedness and control in Part III; 

(d) 

(e) 

the  registration  and  approval  of  establishments  and  transporters,  movements 
and traceability of consignments of animals, germinal products and products of 
animal origin within the Union in Part IV; 

the  entry  of  consignments  of  animals,  germinal  products,  and  products  of 
animal  origin  into  the  Union  and  the  export  of  such  consignments  from  the 
Union in Part V; 

(f) 

the  emergency  measures  to  be  taken  in  the  event  of  a  disease  emergency 
situation in Part VI.  

2. 

The rules referred to in paragraph 1: 

(a) 

ensure 

(i) 

a sustainable agricultural and aquaculture production in the Union;  

(ii) 

the effective functioning of the internal market;  

(iii)  a reduction in the adverse effects on the environment of:  

– 

– 

certain diseases;  

the measures taken to prevent and control diseases; 

(b) 

take into account  

(i) 

the relationship between animal health and:  

– 

– 

– 

– 

– 

public health; 

the environment as well as the impacts of climate change; 

food and feed safety; 

animal welfare; 

food security; 

(ii) 

the  economic,  social,  cultural  and  environmental  consequences  arising 
from the application of disease control and prevention measures. 

EN 

39 

   EN 

Article 2 
Scope of this Regulation 

1. 

This Regulation shall apply to:  

(a)  kept and wild animals;  

(b)  germinal products; 

(c)  products of animal origin; 

(d) 

(e) 

animal  by-products  and  derived  products,  without  prejudice  to  the  rules  laid 
down in Regulation (EC) No 1069/2009; 

facilities,  means  of  transport,  equipment  and  all  other  paths  of  infection  and 
material involved or potentially involved in the spread of transmissible animal 
diseases. 

2. 

This  Regulation  shall  apply  to  transmissible  diseases,  including  zoonoses,  without 
prejudice to the rules laid down in:  

(a)  Decision No 2119/98/EC;  

(b)  Regulation (EC) No 999/2001;  

(c)  Directive 2003/99/EC; 

(d)  Regulation (EC) No. 2160/2003. 

Article 3 
Scope of Part IV on registration, approval, traceability and movements 

1. 

Title I of Part IV shall apply to: 

(a) 

terrestrial animals, and animals that are not terrestrial animals but which may 
transmit diseases affecting terrestrial animals; 

(b)  germinal products from terrestrial animals; 

(c) 

products of animal origin from terrestrial animals. 

2. 

Title II of Part IV shall apply to: 

(a) 

aquatic  animals,  and  animals  that  are  not  aquatic  animals  but  which  may 
transmit diseases affecting aquatic animals;  

(b)  products of animal origin from aquatic animals. 

3. 

Title III of Part IV shall apply to:  

(a) 

animals  other  than  those  defined  as  terrestrial  animals  and  aquatic  animals  in 
Article 4(1)(4); 

EN 

40 

   EN 

(b)  germinal  products  and  products  of  animal  origin  from  the  other  animals 

referred to in point (a). 

4. 

Chapters 1 and 3 of Title I and Chapters 1 and 2 of Title II of Part IV shall not apply 
to pet animals. 

Article 4 
Definitions 

1. 

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

(1) 

'animals' means vertebrate and invertebrate animals; 

(2) 

'terrestrial animals' means birds, terrestrial mammals, bees and bumble bees; 

(3) 

'aquatic  animals'  means  animals  of  the  following  species,  at  all  life  stages, 
including eggs, sperm and gametes: 

(i) 

fish  belonging 
Chondrichthyes, Sarcopterygii and Actinopterygii; 

the  superclass  Agnatha  and 

to 

to 

the  classes 

(ii) 

aquatic molluscs belonging to the phylum Mollusca; 

(iii)  aquatic crustaceans belonging to the subphylum Crustacea; 

(4) 

(5) 

(6) 

'other animals' means animals of species other than those defined as terrestrial 
and aquatic animals; 

'kept animals' means animals which are kept by humans; in the case of aquatic 
animals, aquaculture animals; 

'aquaculture' means the rearing of aquatic animals using techniques designed to 
increase  the  production  of  those  animals  beyond  the  natural  capacity  of  the 
environment and where the animals remain the property of one or more natural 
or  legal  persons  throughout  the  rearing  or  culture  stages,  up  to  and  including 
harvesting,  excluding  the  harvesting  or  catching  for  the  purposes  of  human 
consumption of wild aquatic animals which are subsequently temporarily kept 
awaiting slaughter without being fed;  

(7) 

'aquaculture animals' means aquatic animals subject to aquaculture;  

(8) 

'wild animals' means animals which are not kept animals; 

(9) 

'poultry' means birds that are reared or kept in captivity for:  

(a) 

the production of:  

(i)  meat; 

(ii) 

eggs for consumption; 

(iii)  other products;  

EN 

41 

   EN 

(b) 

restocking supplies of game birds; 

(c) 

the  purposes  of  breeding  of  birds  used  for  the  types  of  production 
referred to in point (a);  

(10)  'captive birds' means any birds other than poultry that are kept in captivity for 
any reason other than those referred to in point (9) including those that are kept 
for shows, races, exhibitions, competitions, breeding or selling; 

(11)  'pet animal' means an animal of the species listed in Annex I, which: 

(a) 

is  kept  in  a  household,  or  in  the  case  of  aquatic  animals,  kept  in  non-
commercial ornamental aquaria;  

(b)  when  moved,  accompanies  for  the  purpose  of  a  non-commercial 
movement the pet keeper, or a natural person acting on behalf of and in 
agreement  with  the  pet  keeper,  and  which  remains  during  such  non-
commercial movement under the responsibility of the pet keeper or such 
person; 

(12)  'pet keeper' means a natural person keeping a pet animal; 

(13)  'non-commercial movement' means any movement of pet animals which does 
not  involve  or  aim,  directly  or  indirectly,  at  a  financial  gain  or  a  transfer  of 
ownership; 

(14)  'disease' means the occurrence of infections and infestations in animals, with or 
without clinical or pathological manifestations, caused by one or more disease 
agents transmissible to animals or to humans; 

(15)  'listed diseases' mean diseases listed in accordance with Article 5(2); 

(16)  'emerging  disease'  means  a  disease  other  than  a  listed  disease  which  has  the 
potential to meet the criteria for listed diseases provided for in Article 6(1)(a) 
due to: 

(a) 

(b) 

(c) 

a  new  disease  resulting  from  the  evolution  or  change  of  an  existing 
disease agent;  

a known disease spreading to a new geographic area or a new population; 
or 

a  previously  unrecognised  disease  agent  or  a  disease  diagnosed  for  the 
first time; 

(17)  'disease profile' means the criteria of a disease referred to in Article 6(1)(a);  

(18)  'listed  species'  means  animal  species  or  group  of  animal  species  listed  in 
accordance  with  Article  7(2),  or,  in  the  case  of  emerging  diseases,  animal 
species or groups of animal species, which meet the criteria for listed species 
laid down in Article 7(2); 

EN 

42 

   EN 

(19)  'hazard' means a disease agent in, or a condition of, an animal or product with 

the potential to have an adverse health effect in humans or animals; 

(20)  'risk'  means  the  likelihood  of  the  occurrence  and  the  likely  magnitude  of  the 
biological and economic consequences of an adverse effect on animal or public 
health; 

(21)  'biosecurity' means the sum of management and physical measures designed to 
reduce the risk of the introduction, development and spread of diseases to, from 
and within:  

(a) 

an animal population, or  

(b) 

an  establishment,  zone,  compartment,  means  of  transport  or  any  other 
facilities, premises or location;  

(22)  'operator' means a natural or legal person, having animals and products under 
their  responsibility,  including  animal  keepers  and  transporters,  but  excluding 
pet keepers and veterinarians; 

(23)  'animal  professional'  means  a  natural  or  legal  person,  with  an  occupational 
relationship with animals or products, other than operators or veterinarians; 

(24)  'establishment'  means  any  premises,  structure,  or  any  environment,  in  which 

animals or germinal products are kept, except for: 

(a) 

households keeping pet animals;  

(b)  non-commercial aquaria keeping aquatic animals;  

(c) 

veterinary practices or clinics; 

(25)  'germinal products' means:  

(a) 

sperm, semen, oocytes and embryos intended for artificial reproduction;  

(b)  hatching eggs; 

(26)  'products of animal origin' means:  

(a) 

food of animal origin, including honey and blood; 

(b) 

(c) 

live  bivalve  molluscs,  live  echinoderms,  live  tunicates  and  live  marine 
gastropods intended for human consumption; and 

animals other than those referred to in (b) destined to be prepared with a 
view to being supplied live to the final consumer; 

(27)  'animal  by-products'  means  entire  bodies  or  parts  of  animals,  products  of 
animal origin or other products obtained from animals which are not intended 
for human consumption, excluding germinal products;  

EN 

43 

   EN 

(28)  'derived  products’  means  products  obtained  from  one  or  more  treatments, 

transformations or steps of the processing of animal by-products; 

(29)  'products' means:  

(a) 

germinal products;  

(b)  products of animal origin;  

(c) 

animal by-products and derived products; 

(30)  'official control' means an official control as defined in point (1) of Article 2 of 
Regulation  (EU)  XXX/XXX  [Publication  office  –  Number  to  be  added:  on 
official controls and other official activities.]; 

(31)  'health  status'  means  the  disease  status  as  regards  all  the  listed  diseases  for  a 

particular listed species with respect to:  

(a) 

an animal; 

(b) 

the animals within: 

(i) 

an establishment;  

(ii) 

a compartment;  

(iii)  a zone;  

(iv)  a Member State; 

(v) 

a third country or territory; 

(32)  'zone' means: 

(a) 

for  terrestrial  animals  a  clearly  defined  part  of  a  Member  State,  third 
country  or  territory  containing  an  animal  subpopulation  with  a  distinct 
health status with respect to a specific disease or specific diseases subject 
to appropriate surveillance, disease control and biosecurity measures;  

(b) 

for  aquatic  animals  a  contiguous  hydrological  system  with  a  distinct 
health  status  with  respect  to  a  specific  disease  or  specific  diseases  that 
forms an area that is referred to in one of the following: 

(i) 

an  entire  water  catchment  from  the  source  of  a  waterway  to  the 
estuary or lake;  

(ii)  more than one water catchment;  

(iii)  part  of  a  water  catchment  from  the  source  of  a  waterway  to  a 
barrier  that  prevents  the  introduction  of  a  specific  disease  or 
diseases;  

(iv)  part of a coastal area with a precise geographical delimitation;  

EN 

44 

   EN 

(v) 

an estuary with a precise geographical delimitation; 

(33)  'water catchment' means an area or basin of land bounded by natural features 

such as hills or mountains, into which all run-off water flows; 

(34)  'compartment'  means  an  animal  subpopulation  contained  in  one  or  more 
establishments  and  in  the  case  of  aquatic  animals  in  one  or  more  aquaculture 
establishments,  under  a  common  biosecurity  management  system  with  a 
distinct  health  status  with  respect  to  a  specific  disease  or  specific  diseases 
subject to appropriate surveillance, disease control and biosecurity measures; 

(35)  'quarantine' means the maintaining of animals in isolation under the control of 
the  competent  authority  with  no  direct  or  indirect  contact  with  other  animals, 
for  the  purposes  of  ensuring  that  there  is  no  spread  of  diseases  while  the 
animals  are  undergoing  observation  for  a  specified  length  of  time  and,  if 
appropriate, testing and treatment; 

(36)  'epidemiological  unit'  means  a  group  of  animals  with  the  same  likelihood  of 

exposure to a disease agent; 

(37)  'outbreak'  means  one  or  more  cases  in  an  establishment,  household  or  other 

place where animals are kept or located; 

(38)  'case' means the official confirmation of the presence of a listed disease or an 

emerging disease in a live or dead animal; 

(39)  'restricted  zone'  means  a  zone  in  which  restrictions  on  the  movements  of 
certain  animals  or  products  and  other  disease  control  measures  are  applied, 
with a view to preventing the spread of a particular disease into areas where no 
restrictions  are  applied;  a  restricted  zone  may,  when  relevant,  include 
protection and surveillance zones; 

(40)  'protection  zone'  means  a  zone  with  one  or  more  disease  cases  which  is 
established  after  the  official  confirmation  of  an  outbreak,  and  where  disease 
control measures are applied in order to prevent the spread of the disease from 
that zone;  

(41)  'surveillance zone' means a zone, established after the official confirmation of 
an  outbreak  and  which  is  situated  around  the  protection  zone,  and  where 
disease  control  measures  are  applied  in  order  to  prevent  the  spread  of  the 
disease from that zone and the protection zone;  

(42)  'hatching eggs' means eggs, laid by poultry, intended for incubation; 

(43)  'ungulates' means the animals listed in Annex II;  

(44)  'germinal product establishment' means:  

(a) 

an establishment for the collection, production, processing and storage of 
germinal products;  

(b) 

a hatchery; 

EN 

45 

   EN 

(45)  'hatchery' means an establishment which collects, stores, incubates and hatches 

eggs for the supply of: 

(a) 

eggs for incubation; 

(b)  day-old chicks or hatchlings of other species; 

(46)  'transporter' means an operator transporting animals on its own account, or for 

a third party; 

(47)  'confined  establishment'  means  any  permanent,  geographically 

limited 
establishment,  created  on  a  voluntary  basis,  and  approved  for  the  purpose  of 
movements, where the animals are:  

(a)  kept or bred for the purposes of exhibitions, education, the conservation 

of species or research; 

(b) 

confined and separated from the surrounding environment; 

(c) 

subject to strict animal health surveillance and biosecurity measures; 

(48)  'assembly  operation'  means  the  assembling  of  kept  terrestrial  animals  from 
more than one establishments for a period shorter than the required residency 
period for that species of animals; 

(49)  'residency period' means the minimum period an animal is required to stay at 

an establishment prior to being moved from that establishment; 

(50)  'IMSOC'  means  the  computerised  information  management  system  provided 
for by Article 130(1) of Regulation (EU) No. XXX/XXX [Publication office: 
Number to be added -on official controls and other official activities]; 

(51)  'disease control aquatic food establishment' means a food business approved in 

accordance with the following provisions:  

(a)  Article  4  of  Regulation  (EC)  No  853/2004,  for  processing  aquaculture 

animals for food purposes;  

(b)  Article  177  of  this  Regulation  for  the  slaughter  of  aquatic  animals  for 

disease control purposes in accordance with Title II of Part III. 

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning amendments to the list of: 

(a) 

pet animals set out in Annex I; 

(b)  ungulates set out in Annex II.  

EN 

46 

   EN 

1. 

2. 

Chapter 2 
Listed diseases and emerging diseases and listed species 

Article 5 
Listing of diseases 

The disease specific rules for the prevention and control of diseases provided for in 
this Regulation shall apply to:  

(a) 

listed diseases;  

(b) 

emerging diseases. 

The  Commission  shall,  by  means  of  implementing  acts,  establish  a  list  of  listed 
diseases, as referred to in paragraph 1(a). 

That  list  shall  comprise  diseases  which  meet  with  the  conditions  laid  down  in  the 
following  points  (a)  and  (b)  of  this  paragraph,  taking  into  account  the  criteria  for 
listing diseases laid down in Article 6: 

(a) 

diseases  which  are  likely  to  have  a  significant  impact  on  at  least  one  of  the 
following: 

(i) 

public health;  

(ii) 

agricultural or aquaculture production or related sectors of the economy;  

(iii) 

the society in Member States and where appropriate in third countries or 
territories;  

(iv) 

the environment; 

(b)  diseases for which risk mitigating measures are available, or can be developed 

and are proportionate to the risks posed by such diseases. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2). 

On duly justified imperative grounds of urgency relating to a disease representing an 
emerging risk of highly significant impact the Commission shall adopt immediately 
applicable  implementing  acts  in  accordance  with  the  procedure  referred  to  in 
Article 255(3). 

Article 6 
Criteria for listing diseases  

1. 

The Commission shall take account of the following criteria in determining whether 
a disease meets the conditions to be listed in accordance with Article 5(2):  

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(a) 

the disease profile, which shall comprise the following: 

(i) 

the animal species concerned by the disease; 

(ii) 

the morbidity and mortality rates of the disease in animal populations; 

(iii) 

the zoonotic character of the disease; 

(iv) 

the capacity to develop resistance to treatments;  

(v) 

the  persistence  of  the  disease  in  an  animal  population  or  in  the 
environment; 

(vi) 

the routes and speed of transmission of the disease between animals and 
when relevant between animals and humans; 

(vii)  the absence or presence and distribution of the disease in the Union, and, 
where the disease is not present in the Union, the risk of its introduction 
into the Union; 

(viii)  the existence of diagnostic and disease control tools; 

(b) 

the impact of the disease on:  

(i) 

agricultural and aquaculture production and other parts of the economy: 

– 

– 

– 

the level of presence of the disease in the Union; 

the loss of production due to the disease; 

other losses; 

(ii)  human health: 

– 

– 

– 

– 

transmissibility between animals and humans;  

transmissibility between humans; 

the severity of human forms of the disease; 

the  availability  of  effective  prevention  or  medical  treatment  in 
humans; 

(iii)  animal welfare; 

(iv)  biodiversity and environmental pollution; 

(c) 

its potential to generate a crisis situation and its potential use in bioterrorism; 

(d) 

the  feasibility,  availability  and  effectiveness  of  the  following  disease 
prevention and control measures: 

(i) 

diagnostic tools and capacities; 

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(ii)  vaccination; 

(iii)  medical treatments; 

(iv)  biosecurity measures; 

(v) 

restrictions on the movement of animals and products; 

(vi)  culling and disposal of animals; 

(e) 

the impact of disease prevention and control measures as regards to: 

(i) 

the direct and indirect costs for the affected sectors and the economy as a 
whole; 

(ii) 

their societal acceptance; 

(iii) 

the welfare of affected subpopulations of kept and wild animals;  

(iv) 

the environment and biodiversity. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning amendments to the criteria provided for in paragraph 1 of this 
Article to take account of technical and scientific progress and the developments of 
relevant international standards. 

Article 7 
Listing of species 

The disease specific rules for listed diseases provided for in this Regulation and the 
rules adopted pursuant to this Regulation shall apply to listed species. 

The Commission shall, by means of implementing acts, establish a list of species, as 
referred to in paragraph 1.  

That list shall comprise those animal species or groups of animal species, which pose 
a considerable risk for the spread of specific listed diseases, taking into account the 
following criteria: 

(a) 

the susceptibility of the animal population at risk; 

(b) 

the duration of the incubation and infective period for the animals; 

(c) 

the capability of those animals to carry those specific diseases. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2). 

On duly justified imperative grounds of urgency relating to a disease representing an 
emerging risk of highly significant impact the Commission shall adopt immediately 
applicable  implementing  acts  in  accordance  with  the  procedure  referred  to  in 
Article 255(3). 

2. 

1. 

2. 

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Article 8 
Application of disease prevention and control rules to listed diseases 

1. 

The Commission shall, by means of implementing acts, determine the application of 
the disease prevention and control rules referred to in the following points to listed 
diseases: 

(a) 

listed diseases subject to rules on: 

(i) 

disease awareness and preparedness provided for in Title I of Part III and 
disease control measures provided for in Chapter 1 of Title II of Part III; 

(ii) 

compartmentalisation provided for in Article 37(1); 

(b) 

listed diseases subject to the disease prevention and control rules on: 

(i) 

compulsory eradication programmes provided for in Article 30(1); 

(ii)  disease-free Member States and zones provided for in Article 36; 

(iii)  compartmentalisation provided for in Article 37(2); 

(iv)  disease control measures provided for in Chapter 2 of Title II of Part III; 

(c) 

listed diseases subject to the disease prevention and control rules on: 

(i) 

voluntary eradication provided for in Article 30(2); 

(ii)  disease-free Member States and zones provided for in Article 36; 

(iii)  compartmentalisation provided for in Article 37(2); 

(iv)  disease control measures provided for in Chapter 2 of Title II of Part III; 

(d) 

listed diseases subject to the disease prevention and control rules on: 

(i)  movement within the Union provided for in Chapters 3 to 7 of Title I and 

Chapters 2, 3 and 4 of Title II of Part IV; 

(ii) 

entry into the Union and export from the Union provided for in Part V; 

(e) 

listed diseases subject to the disease prevention and control rules on:  

(i) 

notification and reporting provided for in Chapter 1 of Part II; 

(ii) 

surveillance provided for in Chapter 2 of Part II. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2). 

On duly justified imperative grounds of urgency relating to a disease representing an 
emerging risk of highly significant impact the Commission shall adopt immediately 

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applicable  implementing  acts  in  accordance  with  the  procedure  referred  to  in 
Article 255(3). 

2. 

The  Commission  shall  take  into  account  the  following  criteria  when  adopting 
implementing acts provided for in paragraph 1: 

(a) 

the level of impact of the disease on animal and public health, animal welfare 
and the economy;  

(b) 

the prevalence, incidence and distribution of the disease in the Union;  

(c) 

the  availability,  feasibility  and  effectiveness  of  the  different  sets  of  disease 
prevention and control measures provided for in this Regulation with respect to 
the disease. 

Chapter 3 
Responsibilities for animal health 

SECTION 1 
OPERATORS, ANIMAL PROFESSIONALS AND PET KEEPERS 

Article 9 
Responsibilities for animal health and biosecurity measures 

1. 

Operators, animal professionals and pet keepers shall: 

(a) 

(b) 

be  responsible  for  the  health  of  kept  animals  and  products  under  their 
responsibility; 

take  appropriate  biosecurity  measures,  taking  into  account  the  risks  involved, 
to  ensure  the  health  of  those  kept  animals  and  products  and  to  prevent  the 
introduction  into,  development  and  multiplication  within  and  spread  between 
and from such kept animals and products under their responsibility of diseases, 
except  where  that  is  specifically  authorised  for  scientific  purposes,  as 
appropriate for:  

(i) 

the categories and species of kept animals and products;  

(ii) 

the type of production. 

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  biosecurity  measures  supplementing  the  rules  laid  down  in 
paragraph 1(b) of this Article. 

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Article 10 
Basic knowledge of animal health 

1. 

Operators and animal professionals shall acquire knowledge of: 

(a) 

animal diseases, including those that are transmissible to humans;  

(b)  biosecurity principles;  

(c) 

the interaction between animal health, animal welfare and human health.  

2. 

The  content  and  the  level  of  knowledge  required  in  accordance  with  paragraph  1 
shall depend on: 

(a) 

the  categories  and  species  of  kept  animals  or  products  under 
responsibility; 

their 

(b) 

the type of production;  

(c) 

the tasks performed.  

3. 

The knowledge provided for in paragraph 1 shall be acquired in one of the following 
ways: 

(a) 

professional experience or training;  

(b) 

existing programmes in agricultural or aquaculture sectors that are relevant for 
animal health;  

(c) 

formal education. 

SECTION 2 
VETERINARIANS AND AQUATIC ANIMAL HEALTH PROFESSIONALS  

Article 11 
Responsibilities of veterinarians and aquatic animal health professionals  

1. 

Veterinarians shall in the course of their activities which fall within the scope of this 
Regulation: 

(a) 

(b) 

take  all  appropriate  measures  to  prevent  the  introduction,  development  and 
spread of diseases; 

ensure  the  early  detection  of  diseases  by  carrying  out  proper  diagnosis  and 
differential  diagnosis  to  rule  out  or  confirm  a  disease  before  symptomatic 
treatment is commenced; 

(c) 

play an active role in:  

(i) 

raising animal health awareness;  

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(ii)  disease prevention;  

(iii) 

the early detection and rapid response to diseases.  

(d) 

cooperate with the competent authority, operators, animal professionals and pet 
keepers  in  the  application  of  the  disease  prevention  and  control  measures 
provided for in this Regulation. 

Aquatic  animal  health  professionals  may  undertake  activities  attributed 
to 
veterinarians under this Regulation in relation to aquatic animals provided that they 
are  authorised  to  do  so  under  national  legislation.  In  that  event,  paragraph  1  shall 
apply to those aquatic animal health professionals. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning the qualifications of veterinarians and aquatic animal health 
professionals undertaking activities which fall within the scope of this Regulation. 

2. 

3. 

SECTION 3 
MEMBER STATES  

Article 12 
Member States responsibilities  

1. 

In order to ensure the competent authority for animal health has the capability to take 
the necessary and appropriate measures, and carry out the activities, required by this 
Regulation, the Member States shall ensure that it has: 

(a) 

(b) 

qualified  personnel,  facilities,  equipment,  financial  resources  and  an  effective 
organisation covering the whole territory of the Member State; 

access  to  laboratories  with  qualified  personnel,  facilities,  equipment  and 
financial  resources to  ensure the rapid and accurate diagnosis and  differential 
diagnosis of listed diseases and emerging diseases; 

(c) 

sufficiently trained veterinarians involved in performing the activities referred 
to in Article 11 which fall within the scope of this Regulation. 

2. 

Member  States  shall  support  operators  and  animal  professionals  in  acquiring, 
maintaining  and  developing  the  basic  knowledge  of  animal  health  provided  for  in 
Article  10  through  relevant  programmes  in  agricultural  or  aquaculture  sectors  or 
formal education. 

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Article 13 
Competent authority's delegation of other official activities 

1. 

The  competent  authority  may  delegate  one  or  more  of  the  following  activities  to 
veterinarians:  

(a) 

activities concerning notification and reporting as provided for in Chapter 1 of 
Part II and surveillance as provided for in Chapter 2 of that Part; 

(b) 

activities related to:  

(i) 

disease awareness, preparedness and control as provided for in Part III; 

(ii) 

registration,  approval,  traceability  and  movements  as  provided  for  in 
Part IV; 

(iii)  emergency measures as provided for in Part VI. 

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253, concerning:  

(a) 

the  circumstances  and  conditions  for  delegating  the  activities  provided  for  in 
paragraph 1; 

(b)  which  other  activities  may  be  delegated  to  veterinarians  in  addition  to  those 
provided for in paragraph 1 of this Article, and under which circumstances and 
under which conditions;  

(c)  minimum  requirements  for  the  training  of  veterinarians  provided  for  in 

Article 12(1)(c). 

The Commission shall take account of the nature of those tasks and the international 
obligations of the Union and the Member States, when adopting those delegated acts.  

Article 14 
Public information 

Where there are reasonable grounds to suspect that animals or products may present a risk, the 
competent authority shall take appropriate steps to inform the general public of the nature of 
the risk and the measures which are taken or about to be taken to prevent or control that risk, 
taking  into  account  the  nature,  seriousness  and  extent  of  that  risk  and  the  public  interest  in 
being informed. 

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SECTION 4 
LABORATORIES, FACILITIES AND OTHER NATURAL AND LEGAL PERSONS 
HANDLING DISEASE AGENTS, VACCINES AND OTHER BIOLOGICAL PRODUCTS 

Article 15 
Obligations of laboratories, facilities and others handling disease agents, vaccines and other 
biological products 

1. 

2. 

Laboratories, facilities and other natural or legal persons handling disease agents for 
the purpose of research, education, diagnosis or the production of vaccines and other 
biological  products  shall,  whilst  taking  into  account  international  standards  where 
they exist: 

(a) 

take  appropriate  biosecurity,  biosafety  and  bio-containment  measures  to 
prevent  the  escape  of  the  disease  agents  and  their  subsequent  contact  with 
animals outside the laboratory or other facility handling disease agents for the 
purpose of research;  

(b) 

ensure  that  the  movement  of  disease  agents,  vaccines  and  other  biological 
products between laboratories or other facilities does not give rise to a risk of 
the spread of listed and emerging diseases. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  the  safety  measures  for  the  laboratories,  facilities  and  other 
natural  or  legal  persons  handling  the  disease  agents,  vaccines  and  other  biological 
products in relation to:  

(a) 

biosecurity, biosafety and bio-containment measures; 

(b)  movement  requirements  for  disease  agents,  vaccines  and  other  biological 

products. 

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PART II 
DISEASE NOTIFICATION AND REPORTING, 
SURVEILLANCE, ERADICATION PROGRAMMES, 
DISEASE-FREE STATUS 

Chapter 1  
Disease notification and reporting 

Article 16 
Notification within Member States 

1. 

Natural and legal persons shall immediately notify: 

(a) 

(b) 

the competent authority in the event of an outbreak or suspicion of an outbreak 
of a listed disease referred to in Article 8(1)(e); 

a  veterinarian  of  abnormal  mortalities  and  other  serious  disease  signs  or 
significant  decreased  production  rates  with  an  undetermined  cause  in  animals 
for further investigation, including sampling for laboratory examination when 
the situation so warrants.  

Member States may decide that notifications provided for in paragraph 1(b) shall be 
directed to the competent authority. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning: 

(a) 

criteria to determine whether the circumstances requiring notification described 
in paragraph 1(b) of this Article occur; 

(b)  detailed rules for the further investigation provided for in paragraph 1(b) of this 

Article. 

Article 17 
Union notification  

Member  States  shall  immediately  notify  the  Commission  and  the  other  Member 
States of any outbreaks of listed diseases referred to in Article 8(1)(e) for which an 
immediate notification is required to ensure the timely implementation of necessary 
risk management measures, taking into account the disease profile. 

The notification provided for in paragraph 1 shall contain the following information 
on the outbreak:  

(a) 

the disease agent and, where relevant, the subtype; 

2. 

3. 

1. 

2. 

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(b) 

the dates of the suspicion and confirmation of the outbreak;  

(c) 

the location of the outbreak;  

(d) 

any related outbreaks; 

(e) 

the animals affected by the outbreak; 

(f) 

any disease control measures taken in relation to the outbreak; 

(g) 

the possible or known origin of the listed disease; 

(h) 

the diagnostic methods used.  

3. 

The Commission shall by means of implementing acts establish which of the listed 
diseases referred to in in Article 8(1)(e) shall be subject to immediate notification by 
the Member States in accordance with paragraph 1 of this Article.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2). 

Article 18 
Union reporting 

1. 

Member  States  shall  report  to  the  Commission  and  to  the  other  Member  States  the 
information on listed diseases referred to in in Article 8(1)(e) for which: 

(a) 

(b) 

an  immediate  notification  of  outbreaks  is  not  required  in  accordance  with 
Article 17(1);  

an  immediate  notification  of  outbreak  is  required  in  accordance  with  Article 
17(1), but additional information is required to be reported to the Commission 
and the other Member States on:  

(i) 

surveillance in accordance with the rules laid down in an implementing 
act adopted in accordance with Article 29; 

(ii) 

an  eradication  programme  in  accordance  with  the  rules  laid  down  in  an 
implementing act adopted in accordance with Article 35.  

2. 

The reports provided for in paragraph 1 shall include information on:  

(a) 

the detection of the listed diseases referred to in paragraph 1; 

(b) 

(c) 

(d) 

the  results  of  surveillance  when  required  in  accordance  with  rules  adopted  in 
accordance with Article 29(b)(ii);  

the  results  of  surveillance  programmes  when  required  in  accordance  with 
Article 27(3) and rules adopted in accordance with Article 29(b)(ii);  

eradication programmes when required in accordance with Article 33 and rules 
laid down in an implementing act adopted in accordance with Article 35. 

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3. 

1. 

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning amending and supplementing the requirements of paragraph 
2 of this Article and reporting on other matters where necessary to ensure an efficient 
application of the disease prevention and control rules of this Regulation.  

Article 19 
Common rules for Union notification and Union reporting 

The Union notification and Union reporting provided for in Articles 17(1) and 18(1) 
shall  be  done  at  times  and  frequencies  which  ensure  transparency  and  the  timely 
application of the necessary risk management measures, taking into account: 

(a) 

the disease profile; 

(b) 

the type of outbreak. 

The Member States shall establish notification and reporting regions for the purpose 
of  the  Union  notification  and  Union  reporting  provided  for  in  Articles  17(1)  and 
18(1). 

Article 20 
Computerised information system for Union notification and Union reporting of diseases  

The  Commission  shall  set  up  and  manage  a  computerised  information  system  for  the 
operation  of  the  mechanisms  and  tools  for  the  Union  notification  and  Union  reporting 
requirements provided for in Articles 17, 18 and 19.  

Article 21 
Implementing powers concerning Union notification and Union reporting and the 
computerised information system 

The  Commission  shall  by  means  of  implementing  acts  lay  down  rules  for  the  Union 
notification  and  Union  reporting  requirements  and  the  computerised  information  system 
provided for in Articles 17 to 20 with respect to: 

(a) 

(b) 

(c) 

(d) 

the information to be provided by the Member States in the Union notification and 
Union reporting provided for in Articles 17(1) and 18(1); 

procedures  for  the  establishment  and  use  of  the  computerised  information  system 
provided for in Article 20 and transitional measures for the migration of the data and 
the information from existing systems into the new system and its full operability;  

the format and structure of the data to be entered into the computerised information 
system provided for in Article 20;  

the deadlines and frequencies of Union notification and Union reporting provided for 
in Articles 17(1) and 18(1);  

(e) 

Union notification and Union reporting regions provided for in Article 19(2). 

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Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 255(2). 

Chapter 2 
Surveillance 

Article 22 
Operators' obligation for surveillance  

For the purpose of detecting the presence of listed diseases and emerging diseases, operators 
shall:  

(a) 

(b) 

(c) 

1. 

observe the health and behaviour of animals under their responsibility; 

observe  any  changes  in  the  normal  production  parameters  in  the  establishments, 
animals  or  germinal  products  under  their  responsibility,  that  may  give  rise  to  a 
suspicion of being caused by a listed disease or emerging disease; 

look for abnormal mortalities and other serious disease signs in animals under their 
responsibility. 

Article 23 
Animal health visits 

Operators  shall  ensure  that  establishments  under  their  responsibility  receive  animal 
health  visits  from  a  veterinarian  when  appropriate  due  to  the  risks  posed  by  the 
establishment, taking into account: 

(a) 

the type of establishment; 

(b) 

the categories and species of kept animals on the establishment; 

(c) 

any other relevant surveillance, quality assurance schemes or official controls 
that the kept animals and type of establishment are subject to. 

Those animal health visits shall be at frequencies that are proportionate to the risks 
posed by the establishment. 

They may be combined with visits for other purposes. 

2. 

The animal health visits provided for in paragraph 1 shall be for the purposes of: 

(a) 

the  detection  of  any  signs  indicative  of  the  occurrence  of  listed  diseases  or 
emerging diseases; 

(b)  providing advice to the operator on biosecurity and other animal health matters, 
as relevant for the type of establishment and the categories and species of kept 
animals on the establishment. 

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Article 24 
Delegation of powers concerning animal health visits 

The Commission shall be empowered to adopt delegated acts in accordance with Article 253 
concerning: 

(a) 

supplementing:  

(i) 

the  criteria  laid  down  in  Article  23(1)  to  be  taken  into  account  when 
determining:  

– 

– 

which type of establishments must be subject to animal health visits;  

the frequency of such animal health visits; 

(ii) 

the  requirements  laid  down  in  Article  23(2)  as  regards  the  content  and 
frequency  of  animal  health  visits  for  the  different  types  of  establishments,  to 
ensure that the purposes of the animal health visits are achieved; 

(b) 

determining the types of establishments to be subject to animal health visits.  

Article 25 
The competent authority's obligation for surveillance 

1. 

2. 

3. 

The competent authority shall conduct surveillance for the presence of listed diseases 
referred to in Article 8(1)(e) and for emerging diseases.  

The surveillance shall be designed to ensure the timely detection of the presence of 
the listed diseases referred to in Article 8(1)(e) and emerging diseases by collecting, 
collating and analysing relevant information relating to the disease situation. 

The competent authority shall ensure that the surveillance information provided for 
in paragraph 1 is collected and used in an effective and efficient manner. 

Article 26 
Methodology, frequency and intensity of surveillance 

The design, means, diagnostic methods, frequency, intensity, targeted animal population, and 
sampling  patterns  of  the  surveillance  provided  for  in  Article  25(1)  shall  be  appropriate  and 
proportionate to the objectives of the surveillance, taking into account:  

(a) 

(b) 

(c) 

the disease profile;  

the risk factors involved;  

the health status in:  

(i) 

the Member State, zone or compartment thereof subject to the surveillance; 

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(ii) 

the Member States and third countries or territories, which either border on, or 
from  which  animals  and  products  enter  into  that  Member  State,  zone  or 
compartment thereof; 

(d) 

surveillance conducted by operators in accordance with Article 22, or by other public 
authorities.  

1. 

2. 

3. 

Article 27 
Surveillance programmes 

The competent authority shall undertake surveillance provided for in Article 25(1) in 
the  framework  of  a  surveillance  programme,  when  structured  surveillance  is 
necessary due to: 

(a) 

the disease profile;  

(b) 

the risk factors involved. 

Member State establishing a surveillance programme in accordance with paragraph 1 
shall inform the Commission and the other Member States thereof.  

Member State undertaking a surveillance programme in accordance with paragraph 1 
shall  submit  regular  reports  on  the  results  of  that  surveillance  programme  to  the 
Commission.  

Article 28 
Delegation of powers 

The Commission shall be empowered to adopt delegated acts in accordance with Article 253 
concerning: 

(a) 

(b) 

the  design,  means,  diagnostic  methods,  frequency,  intensity,  targeted  animal 
population, and sampling patterns of the surveillance as provided for in Article 26;  

the  criteria  for  the  official  confirmation  and  case  definitions  of  listed  diseases 
referred to in Article 8(1)(e) and where relevant emerging diseases; 

(c) 

requirements for surveillance programmes provided for in Article 27(1) regarding: 

(i) 

the contents of surveillance programmes; 

(ii) 

the information to be included in the submission of surveillance programmes in 
accordance  with  Article  27(2)  and  regular  reports  in  accordance  with  Article 
27(3); 

(iii) 

the period of application of surveillance programmes. 

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Article 29 
Implementing powers 

The  Commission  shall  by  means  of  implementing  acts,  lay  down  requirements  concerning 
surveillance  and  surveillance  programmes  provided  for  in  Articles  26  and  27  and  rules 
adopted pursuant to Article 28 on: 

(a) 

establishing  which  of  the  listed  diseases  referred  to  in  Article  8(1)(e)  are  to  be 
subject to surveillance programmes; 

(b) 

the format and procedure for: 

(i) 

the submission of surveillance programmes for information to the Commission 
and other Member States;  

(ii) 

the reporting to the Commission on the results of the surveillance.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 255(2). 

Chapter 3  
Eradication programmes 

Article 30 
Compulsory and voluntary eradication programmes 

1. 

Member States which are not free or not known to be free from one or more of the 
listed  diseases  referred  to  in  Article  8(1)(b)  in  their  whole  territory  or  in  zones  or 
compartments thereof, shall: 

(a) 

establish a programme for the eradication of or demonstration of freedom from 
that listed disease, to be carried out in the animal populations concerned by that 
disease and covering the relevant parts of their territory or the relevant zones or 
compartments thereof ("compulsory eradication programme"); 

(b) 

submit  the  draft  compulsory  eradication  programme  to  the  Commission,  for 
approval.  

2. 

Member States which are not free or not known to be free from one or more of the 
listed  diseases  referred  to  in  Article  8(1)(c)  and  which  decide  to  establish  a 
programme  for  the  eradication  of  that  listed  disease  to  be  carried  out  in  the  animal 
populations concerned by it and covering the relevant parts of their territory or zones 
or compartments thereof ("voluntary eradication programme") shall submit it to the 
Commission for approval 

3. 

The Commission shall, by means of implementing acts, approve: 

(a) 

draft  compulsory  eradication  programmes  submitted  to  it  for  approval  in 
accordance with paragraph 1; 

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(b)  draft  voluntary  eradication  programmes  submitted  to  it  for  approval  in 

accordance with paragraph 2. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2). 

On  duly  justified  imperative  grounds  of  urgency  relating  to  a  listed  disease 
representing  a  risk  of  highly  significant  impact  the  Commission  shall  adopt 
immediately applicable implementing acts provided for in point (a) of this paragraph 
in accordance with the procedure provided for in Article 255(3). 

The  Commission  may,  by  means  of  implementing  acts,  amend  or  terminate  where 
necessary  eradication  programmes  approved  in  accordance  with  points  (a)  and  (b). 
Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2).  

4. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning: 

(a) 

the  objectives,  disease  control  strategies  and 
compulsory and voluntary eradication programmes; 

intermediate 

targets  of 

(b)  derogations from the requirement for the submission of compulsory eradication 
programmes  and  voluntary  eradication  programmes  for  approval,  as  provided 
for  in  paragraph  1(b)  and  paragraph  2  of  this  Article,  where  such  approval  is 
not  necessary  due  to  the  adoption  of  rules  regarding  those  programmes  in 
accordance with Articles 31(2) and 34(2) and Article 35; 

(c) 

the information to be provided by Member States to the Commission and to the 
other Member States concerning derogations from the requirement for approval 
of compulsory eradication programmes and voluntary eradication programmes 
provided for in (b). 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  amending  or  terminating  rules  adopted  pursuant  to  point  (b)  of  this 
paragraph. 

Article 31 
Measures under the compulsory and voluntary eradication programmes 

1. 

Compulsory  eradication  programmes  and  voluntary  eradication  programmes  shall 
consist of at least the following measures: 

(a) 

disease  control  measures  for  the  eradication  of  the  disease  agent  from 
establishments,  compartments  and  zones  in  which  the  disease  occurs  and  to 
prevent re-infection; 

(b) 

surveillance carried out in accordance with the rules laid down in Article 26 to 
29 to demonstrate: 

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(i) 

the  effectiveness  of  the  disease  control  measures  provided  for  in 
point (a); 

(ii) 

freedom from the listed disease; 

(c) 

disease  control  measures  to  be  taken  in  the  event  of  positive  surveillance 
results. 

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning: 

(a) 

disease control measures as provided for in paragraph 1(a);  

(b)  disease  control  measures  to  be  taken  to  avoid  re-infection  of  the  targeted 
animal  population  with  the  disease  in  question  in  establishments,  zones  and 
compartments; 

(c) 

the  surveillance  design,  means,  diagnostic  methods,  frequency,  intensity, 
targeted animal population and sampling patterns as provided for in Article 26; 

(d)  disease control measures to be taken in the event of the occurrence of positive 

results for the listed disease as provided for in paragraph 1(c); 

(e) 

vaccination.  

Article 32 
Content of the submission of compulsory and voluntary eradication programmes 

Member  States  shall  include  the  following  information  in  applications  for  compulsory  and 
voluntary  eradication  programmes  submitted  to  the  Commission  for  approval  in  accordance 
with Article 30(1) and (2): 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

a  description  of  the  epidemiological  situation  of  the  listed  disease  covered  by  the 
compulsory or voluntary eradication programme;  

a description and demarcation of the geographical and administrative area covered by 
the compulsory or voluntary eradication programme; 

a  description  of  the  disease  control  measures  of  the  compulsory  or  voluntary 
eradication  programme  as  provided  for  in  Article 31(1)  and  the  rules  adopted 
pursuant to Article 31(2);  

the estimated duration of the compulsory or voluntary eradication programme; 

the  intermediate  targets  and  the  disease  control  strategies  for  undertaking  the 
compulsory or voluntary eradication programme; 

an  analysis  of  the  estimated  costs  and  benefits  of  the  compulsory  or  voluntary 
eradication programme. 

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Article 33 
Reporting 

The  Member  State  undertaking  the  compulsory  or  voluntary  eradication  programme  shall 
submit to the Commission:  

(a) 

regular intermediate reports to monitor the intermediate targets referred to in Article 
32(e) of the on-going compulsory or voluntary programmes; 

(b) 

a final report after its completion.  

Article 34 
Period of application of eradication programmes 

1. 

Compulsory and voluntary eradication programmes shall apply until: 

(a) 

(b) 

the  conditions  to  apply  for  disease-free  status  in  the  territory  of  the  Member 
State or zone as provided for in Articles 36(1), or compartment, as provided for 
in Article 37(1) are fulfilled; or 

in  the  case  of  voluntary  eradication  programmes,  the  conditions  to  apply  for 
disease-free status cannot be achieved and that programme no longer fulfils its 
purpose; in that event it shall be withdrawn by the competent authority or by 
the  Commission  in  accordance  with  the  procedure  under  which  it  was 
established. 

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning supplementing and amending the requirements provided for 
in paragraph 1 of this Article as regards the period of application of compulsory and 
voluntary eradication programmes. 

Article 35 
Implementing powers 

The Commission shall by means of implementing acts, lay down the information, format and 
procedural requirements concerning the rules provided for in Articles 30 to 33 on: 

(a) 

(b) 

(c) 

the submission of draft compulsory and draft voluntary eradication programmes for 
approval;  

performance indicators; 

the  reporting  to  the  Commission  and  other  Member  States  on  the  results  of  the 
implementation of compulsory or voluntary eradication programmes.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 255(2). 

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Chapter 4 
Disease-free status 

Article 36 
Disease-free Member States and zones  

1. 

A Member State may apply to the Commission for approval of the disease-free status 
for  one  or  more  of  the  listed  diseases  referred  to  in  Article  8(1)(b)  and  (c)  for  its 
entire  territory,  or  for  one  or  more  zones  thereof  provided  that  one  or  more  of  the 
following conditions are fulfilled: 

(a) 

(b) 

(c) 

none of the listed species for the disease covered by the application for disease-
free  status  is  present  in  the  entire  territory  of  the  Member  State  or  in  the 
relevant zone or zones covered by that application;  

the disease agent is known not to be able to survive in the entire territory of the 
Member State, or in the relevant zone or zones covered by that application;  

in the event of listed diseases only transmitted by vectors, none of the vectors 
are present, or are known not to be able to survive in the entire territory of the 
Member State, or in the relevant zone or zones covered by that application; 

(d) 

freedom from the listed disease has been demonstrated by: 

(i) 

an  eradication  programme  complying  with  the  rules  laid  down  in 
Article 31(1) and rules adopted pursuant to paragraph 2 of that Article; or 

(ii)  historical and surveillance data. 

Applications  by  Member  States  for  disease-free  status  shall  include  evidence  to 
substantiate that the conditions for disease-free status laid down in  paragraph  1  are 
fulfilled. 

The  Commission  shall,  by  means  of  an  implementing  act  approve,  subject  to 
amendments where necessary, applications by Member States for disease-free status, 
when the conditions provided for in paragraph 1 and 2 are fulfilled.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2). 

Article 37 
Compartments  

A Member State may apply to the Commission for the recognition of the disease-free 
status of compartments for  listed diseases referred to in Article 8(1)(a), and for the 
protection of such disease-free status of that compartment in the event of outbreaks 
of one or more of those listed diseases in its territory provided that:  

2. 

3. 

1. 

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(a) 

(b) 

(c) 

the  introduction  of  the  listed  disease  or  listed  diseases  covered  by  that 
application  can  be  effectively  prevented  at  compartment  level,  taking  into 
account the disease profile; 

the  compartment  covered  by  the  application  is  subject  to  a  single  common 
biosecurity  management  system  to  ensure  the  disease-free  status  of  all 
establishments forming part of it; 

the  compartment  covered  by  the  application  has  been  approved  by  the 
competent  authority  for  the  purposes  of  movements  of  animals  and  products 
thereof in accordance with: 

(i)  Articles  94  and  95  for  compartments  keeping  terrestrial  animals  and 

products thereof; 

(ii)  Articles 181 and 182 for compartments keeping aquaculture animals and 

products thereof. 

2. 

A  Member  State  may  apply  to  the  Commission  for  the  recognition  of  disease-free 
status  of  compartments  for  one  or  more  of  the  listed  diseases  referred  to  in 
Article 8(1)(b) and (c), provided that: 

(a) 

the  introduction  of  the  listed  disease  or  listed  diseases  covered  by  that 
application  can  be  effectively  prevented  at  compartment  level,  taking  into 
account the disease profile; 

(b)  one or more of the following conditions are complied with:  

(i) 

the conditions provided for in Article 36(1)(a) to (d);  

(c) 

(d) 

(ii) 

the establishments of the compartment start or resume their activities and 
have established a common biosecurity management system to ensure the 
disease freedom of the compartment; 

the  operators  in  control  of  the  establishments  of  the  compartment  have  a 
common  biosecurity  management  system  in  place  to  ensure  that  the  disease-
free status of the compartment is guaranteed;  

the  compartment  covered  by  the  application  has  been  approved  by  the 
competent  authority  for  the  purposes  of  movements  of  animals  and  products 
thereof in accordance with: 

(i)  Articles  94  and  95  for  compartments  keeping  terrestrial  animals  and 

products thereof; 

(ii)  Articles 181 and 182 for compartments keeping aquaculture animals and 

products thereof. 

3. 

Applications  by  Member  States  for  the  recognition  of  disease-free  status  of 
compartments  in  accordance  with  paragraphs  1  and  2  shall  include  evidence  to 
substantiate that the conditions laid down in those paragraphs are fulfilled.  

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4. 

The  Commission  shall,  by  means  of  implementing  acts  recognise,  subject  to 
amendments  where  necessary,  the  disease-free  status  of  compartments,  when  the 
conditions provided for in paragraphs 1 or 2 and 3 are fulfilled.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2). 

5. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning:  

(a) 

the requirements for the recognition of the disease free status of compartments 
as  provided  for  in  paragraphs  1  and  2  of  this  Article,  taking  into  account  the 
profile  of  the  listed  diseases  referred  to  in  Article 8(1)(a),  (b)  and  (c), 
concerning at least: 

(i) 

surveillance and other evidence needed to substantiate disease-freedom; 

(ii)  biosecurity measures; 

(b) 

(c) 

the  detailed  rules  for  the  approval  by  the  competent  authority  of  the  disease-
free status of compartments provided for in paragraphs 1 and 2 of this Article; 

compartments,  which  are  located  in  the  territory  of  more  than  one  Member 
State. 

Article 38 
Lists of disease-free zones or compartments 

Each Member State shall establish and maintain an updated list of: 

(a) 

(b) 

disease-free territory or zones as provided for in Article 36(1); 

disease-free status of compartments as provided for in Article 37(1) and (2). 

Member States shall make those lists publicly available. 

Article 39 
Delegation of powers concerning the disease-free status of Member States and zones 

The Commission shall be empowered to adopt delegated acts in accordance with Article 253 
concerning: 

(a) 

detailed rules for the disease-free status of Member States and zones thereof taking 
into account the different disease profiles concerning: 

(i) 

the  criteria  to  be  used  to  substantiate  claims  by  Member  States  that  no  listed 
species are present or able to survive and the evidence required to substantiate 
such claims, as provided for in Article 36(1)(a); 

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(ii) 

the criteria to be used to substantiate that a disease agent or vector is not able to 
survive and the evidence required to substantiate such claims as provided for in 
Article 36(1)(b) and (c); 

(iii) 

the criteria to be used to determine freedom from the disease, as referred to in 
Article 36(1)(d); 

(iv)  surveillance and other evidence needed to substantiate disease freedom; 

(v)  biosecurity measures; 

(vi) 

restrictions  and  conditions  for  vaccination  in  disease  free  Member  States  and 
zones thereof; 

(vii)  establishment of the zones separating the disease-free zones or zones under the 

eradication programme from the restricted zones ("buffer zones"); 

(viii)  zones which extend over the territory of more than one Member State; 

(b) 

(c) 

derogations from the requirement for the approval by the Commission of disease-free 
status for one or more listed diseases referred to in Article 8(1)(b) and (c) as provided 
for  in  Article  36(1),  where  such  approval  is  not  necessary  due  to  detailed  rules  for 
disease freedom having been laid down in rules adopted pursuant to point (a) of this 
Article; 

the information to be provided by Member States to the Commission and the other 
Member  States  to  substantiate  the  declarations  of  disease-free  status,  without  the 
adoption of an implementing act in accordance with Article 36(3), as provided for in 
point (b) of this Article. 

Article 40 
Implementing powers 

The Commission shall by means of implementing acts, lay down requirements for the disease-
free status of territories, zones and compartments concerning the rules provided for in Articles 
36,  37  and  38,  and  rules  laid  down  in  delegated  acts  adopted  pursuant  to  Article  39 
concerning:  

(a) 

(b) 

establishing for which of the listed diseases referred to in Article 8(1)(a), (b) and (c), 
the disease-free compartments may be established in accordance with Article 37; 

requirements  concerning  the  information  to  be  submitted,  and  the  format  and 
procedures for:  

(i) 

the applications for the disease-free status of the entire territory of the Member 
State, or zones and compartments thereof; 

(ii) 

the information exchange between the Member States and the Commission on 
disease-free Member States, or zones and compartments thereof. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 255(2). 

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Article 41 
Maintenance of disease-free status 

1. 

Member States shall only maintain disease-free status for their territories, or zones or 
compartments thereof as long as: 

(a) 

(b) 

(c) 

the conditions for disease-free status laid down in Article 36(1) and 37(1) and 
(2), and rules laid down pursuant to paragraph 3 of this Article and Article 39 
remain fulfilled; 

surveillance, taking into account the requirements provided for in Article 26, is 
undertaken to verify that the territory, zone or compartment remains free of the 
listed disease for which it was approved or recognised for disease-free status; 

restrictions  are  applied  on  movements  of  animals,  and  where  relevant  their 
products,  of  listed  species  for  the  listed  disease  for  which  the  disease-free 
status was approved or recognised, into the territory, zone or compartment, in 
accordance with the rules laid down in Parts IV and V;  

(d)  other biosecurity measures are applied to prevent the introduction of the listed 

disease for which it was approved or recognised for disease-free status. 

A Member State shall immediately inform the Commission if the conditions referred 
to in paragraph 1 for maintaining disease-free status no longer apply.  

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning the following conditions for maintaining disease-free status: 

2. 

3. 

(a) 

surveillance as provided for in paragraph 1(b); 

(b)  biosecurity measures as provided for in paragraph 1(c). 

Article 42 
Suspension, withdrawal and restoration of disease-free status 

1. 

Where  a  Member  State  has  reason  to  suspect  that  any  of  the  conditions  for 
maintaining  its  status  as  a  disease-free  Member  State,  or  zone  or  compartment 
thereof have been breached, it shall immediately: 

(a) 

suspend movements of the listed species, for the listed disease for which it was 
approved or recognised for disease-free status, to other Member States, zones 
or compartments with a higher health status for that listed disease  

(b)  where  relevant  for  the  prevention  of  the  spread  of  a  listed  diseas  for  which 
disease-free  status  was  approved  or  recognised,  apply  the  disease  control 
measures provided for in Title II of Part III. 

2. 

The measures provided for in paragraph 1 shall be lifted where further investigation 
confirms that: 

(a) 

the suspected breach has not taken place; or  

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3. 

4. 

(b) 

the suspected breach did not have significant impact and the Member State can 
provide assurances that the conditions for maintaining its disease-free status are 
again fulfilled. 

Where  further  investigation  by  the  Member  State  confirms  a  significant  likelihood 
that the listed disease for which it obtained the disease-free status or other significant 
breaches  of  the  conditions  for  maintaining  disease-free  status  have  occurred,  the 
Member State shall immediately inform the Commission. 

The Commission shall, by means of implementing acts, withdraw the approval of the 
disease-free  status  of  a  Member  State  or  zone  granted  in  accordance  with 
Article 36(3) or the recognition of the disease-free status of a compartment granted in 
accordance with Article 37(4) after obtaining the information from the Member State 
referred  to  in  paragraph  3  of  this  Article  that  the  conditions  for  maintaining  the 
disease-free status are no longer met .  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2). 

On  duly  justified  imperative  grounds  of  extreme  urgency,  where  the  listed  disease 
referred to in paragraph 3 of this Article spreads in a rapid manner with risk of highly 
significant  impact  on  animal  or  public  health,  the  economy  or  society,  the 
Commission  shall  adopt  immediately  applicable  implementing  acts  in  accordance 
with the procedure provided for in Article 255(3). 

5. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  the  rules  for  the  suspension,  withdrawal  and  restoration  of 
disease-free status provided for in paragraphs 1 and 2 of this Article. 

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PART III 
DISEASE AWARENESS, PREPAREDNESS AND 
CONTROL 

TITLE I 
Disease awareness and preparedness 

Chapter 1 
Contingency plans and simulation exercises 

Article 43 
Contingency plans 

1. 

2. 

The Member States shall draw up and keep up-to-date-contingency plans and where 
necessary detailed instruction manuals laying down the measures to be taken in the 
Member  State  in  the  event  of  the  occurrence  of  a  case  or  an  outbreak  of  a  listed 
disease referred to in Article 8(1)(a) or an emerging diseases in order to ensure a high 
level of disease awareness, preparedness and rapid response. 

The contingency plans and where applicable detailed instruction manuals shall cover 
at least the following matters:  

(a) 

(b) 

the  establishment  of  a  chain  of  command  within  the  competent  authority  and 
with  other  public  authorities  to  ensure  a  rapid  and  effective  decision-making 
process at Member State, regional and local level; 

the framework for cooperation between the competent authority and the other 
public  authorities  involved  to  ensure  that  actions  are  taken  in  a  coherent  and 
coordinated manner; 

(c) 

access to:  

(i) 

facilities;  

(ii) 

laboratories;  

(iii)  equipment;  

(iv)  personnel; 

(v) 

emergency funds;  

(vi)  all other appropriate materials and resources necessary for the rapid and 
efficient eradication of the listed diseases referred to in Article 8(1)(a) or 
the emerging diseases;  

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(d) 

the  availability  of  the  following  centres  and  groups  with  the  necessary 
expertise to assist the competent authority: 

(i) 

a functional central disease control centre;  

(ii) 

regional  and  local  disease  control  centres,  as  appropriate  for  the 
administrative and geographical situation of the Member States; 

(iii)  operational expert groups; 

(e) 

the implementation of the disease control measures provided for in Chapter 1 
of Title II for the listed diseases referred to in Article 8(1)(a) and for emerging 
diseases;  

(f) 

provisions on emergency vaccination where appropriate;  

(g)  principles for the geographical demarcation of the restricted zones established 

by the competent authority in accordance with Article 64(1); 

(h) 

coordination  with  neighbouring  Member  States  and  neighbouring  third 
countries and territories, where appropriate.  

Article 44 
Delegation of powers and implementing powers for contingency plans 

1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  detailed  requirements  and  conditions  for  the  contingency 
plans provided for in Article 43(1) and to supplement the requirements laid down in 
Article 43(2), taking into account: 

(a) 

the  objectives  of  the  contingency  plans  to  ensure  a  high  level  of  disease 
awareness, preparedness and rapid response; 

(b) 

the disease profile of the listed diseases referred to in Article 8(1)(a); 

(c) 

new knowledge of and developments in disease control tools. 

2. 

The  Commission  shall,  by  means  of  implementing  acts,  lay  down  requirements 
concerning  the  practical  implementation  in  the  Member  States  of  the  contingency 
plans provided for in Article 43(1) with regard to:  

(a) 

the matters provided for in Article 43(2)(a) and (c) to (h);  

(b)  other operational aspects of the contingency plans in the Member States; 

(c) 

detailed  requirements  and  conditions  for  the  practical  implementation  of  the 
delegated acts adopted pursuant to paragraph 1 of this Article. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2). 

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Article 45 
Simulation exercises  

1. 

The  competent  authority  shall  ensure  that  simulation  exercises  concerning  the 
contingency plans provided for in Article 43(1) are carried out regularly: 

(a) 

to ensure a high level of disease awareness, preparedness and rapid response in 
the Member State; 

(b) 

to verify the functionality of those contingency plans.  

2. 

3. 

4. 

Where  feasible  and  appropriate,  simulation  exercises  shall  be  carried  out  in  close 
collaboration  with  the  competent  authorities  of  neighbouring  Member  States  and 
neighbouring third countries and territories.  

Member  States  shall  make  available  on  request  a  report  on  the  main  results  of  the 
simulation exercises to the Commission and to the other Member States. 

When  appropriate  and  necessary  the  Commission  shall,  by  means  of  implementing 
acts, lay down rules concerning the practical implementation of simulation exercises 
in the Member States on: 

(a) 

the frequencies, contents and format of simulation exercises; 

(b) 

(c) 

simulation  exercises  covering  more  than  one  listed  disease  referred  to  in 
Article 8(1)(a); 

collaboration  between  neighbouring  Member  States  and  with  neighbouring 
third countries and territories. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2). 

Chapter 2 
The use of veterinary medicinal products for disease prevention and 
control  

Article 46 
The use of veterinary medicinal products for disease prevention and control 

1. 

The  Member  States  may  take  measures  concerning  the  use  of  veterinary  medicinal 
products for listed diseases, to ensure the most efficient disease prevention or control 
for those diseases, provided that such measures comply with the rules on the use of 
veterinary  medicinal  products  laid  down  in  delegated  acts  adopted  pursuant  to 
Article 47.  

Those measures may cover the following:  

(a) 

prohibitions and restrictions on the use of veterinary medicinal products; 

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(b) 

the compulsory use of veterinary medicinal products. 

2. 

Member States shall take the following criteria into consideration when determining 
whether  or  not  to  use  and  how  to  use  veterinary  medicinal  products  as  disease 
prevention and control measures for a specific listed disease: 

(a) 

the disease profile; 

(b) 

the distribution of the listed disease in: 

(i) 

the Member State;  

(ii) 

the Union; 

(iii)  where relevant, in neighbouring third countries and territories;  

(iv) 

third  countries  and  territories  from  which  animals  and  products  are 
brought into the Union; 

(c) 

the availability, effectiveness and risks of the veterinary medicinal products; 

(d) 

(e) 

the  availability  of  diagnostic  tests  for  detecting  infections  in  animals  treated 
with the veterinary medicinal products; 

the  economic,  social,  animal  welfare  and  environmental  impact  of  the  use  of 
the  veterinary  medicinal  products  compared  to  other  available  disease 
prevention and control strategies. 

3. 

Member  States  shall  take  appropriate  preventive  measures  concerning  the  use  of 
veterinary medicinal products for scientific studies or for the purposes of developing 
and testing them under controlled conditions to protect animal and public health. 

Article 47  
Delegation of powers for the use of veterinary medicinal products 

1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning: 

(a) 

prohibitions and restrictions on the use of veterinary medicinal products; 

(b) 

specific  conditions  for  the  use  veterinary  medicinal  products  for  a  specific 
listed disease; 

(c) 

the compulsory use of veterinary medicinal products; 

(d) 

risk  mitigating  measures  to  prevent  the  spread  of  listed  diseases  through 
animals  treated  with  the  veterinary  medicinal  products  or  products  from  such 
animals; 

(e) 

surveillance  following  the  use  of  vaccines  and  other  veterinary  medicinal 
products for specific listed diseases. 

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2. 

3. 

1. 

The  Commission  shall  take  into  account  the  criteria  provided  for  in  Article  46(2) 
when laying down the rules provided for in paragraph 1 of this Article. 

Where in the case of emerging risks, imperative grounds of urgency so require, the 
procedure  provided  for  in  Article  254  shall  apply  to  rules  adopted  pursuant  to 
paragraph 1 of this Article. 

Chapter 3 
Antigen, vaccine and diagnostic reagent banks 

Article 48 
The establishment of Union antigen, vaccine and diagnostic reagent banks  

For  listed  diseases  referred  to  in  Article  8(1)(a)  for  which  vaccination  is  not 
prohibited by a delegated act adopted pursuant to Article 47(1), the Commission may 
establish  and  be  responsible  for  managing  Union  antigen,  vaccine  and  diagnostic 
reagent  banks  for  the  storage  and  replacement  of  stocks  of  one  or  more  of  the 
following biological products: 

(a) 

antigens;  

(b)  vaccines;  

(c) 

vaccine master seed-stocks; 

(d)  diagnostic reagents. 

2. 

The Commission shall ensure that the Union antigen, vaccine and diagnostic reagent 
banks provided for in paragraph 1: 

(a) 

(b) 

(c) 

store  sufficient  stocks  of  the  appropriate  type  of  antigens,  vaccines,  vaccine 
master  seed-stocks  and  diagnostic  reagents  for  the  specific  listed  disease, 
taking into account the needs of Member States estimated in the context of the 
contingency plans provided for in Article 43(1); 

receive regular supplies and timely replacements of antigens, vaccines, vaccine 
master seed-stocks and diagnostic reagents;  

are maintained and moved under the appropriate biosecurity, biosafety and bio-
containment  standards  as  provided  for  in  Article  15(1)  and  delegated  acts 
adopted pursuant to Article 15(2); 

3. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning: 

(a) 

the  management,  storage  and  replacement  of  stocks  of  the  Union  antigen, 
vaccine and diagnostic reagent banks as provided for in paragraphs 1 and 2; 

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(b) 

the biosecurity, biosafety and bio-containment requirements for their operation 
taking  into  account  the  requirements  provided  for  in  Article  15(1)  and 
delegated acts adopted pursuant to Article 15(2). 

Article 49 
Access to the Union antigen, vaccine and diagnostic reagent banks 

1. 

The Commission shall provide for the delivery of the biological products referred to 
in Article 48(1) from the Union antigen, vaccine and diagnostic reagent banks upon 
request, provided that stocks are available, to:  

(a)  Member States; 

(b) 

third  countries  or  territories,  provided  that  it  is  primarily  intended  to  prevent 
the spread of a disease into the Union. 

2. 

The Commission shall prioritise the access provided for in paragraph 1 in the event 
of the limited availability of stocks taking into account: 

(a) 

the disease circumstances under which the request is made; 

(b) 

(c) 

the existence of a national antigen, vaccine and diagnostic reagent bank in the 
requesting Member State or third country or territory; 

the  existence  of  Union  measures  for  compulsory  vaccination  laid  down  in 
delegated acts adopted pursuant to Article 47(1). 

Article 50 
Implementing powers concerning the Union antigen, vaccine and diagnostic reagent banks 

The  Commission  shall,  by  means  of  implementing  acts,  lay  down  rules  for  Union  antigen, 
vaccine  and  diagnostic  reagent  banks  specifying  for  the  biological  products  referred  to  in 
Article 48(1): 

(a) 

(b) 

(c) 

(d) 

(e) 

which of those biological products are to be included in the Union antigen, vaccine 
and  diagnostic  reagent  banks  and  for  which  of  the  listed  diseases  referred  to  in 
Article 8(1)(a);  

the  types  of  those  biological  products  that  are  to  be  included  in  the  Union  antigen, 
vaccine  and  diagnostic  reagent  bank  and  in  what  quantities  for  each  specific  listed 
disease referred to in Article 8(1)(a), for which the bank exists; 

the requirements concerning the supply, storage and replacement of those biological 
products; 

the  delivery  of  those  biological  products  from  the  Union  antigen,  vaccine  and 
diagnostic reagent banks to the Member States and to third countries and territories; 

procedural and technical requirements for the inclusion of those biological products 
in the Union antigen, vaccine and diagnostic reagent banks and for requesting access 
to them. 

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Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 255(2).  

On  duly  justified  imperative  grounds  of  urgency  relating  to  a  listed  disease  referred  to  in 
Article  8(1)(a)  representing  a  risk  of  highly  significant  impact  the  Commission  shall  adopt 
immediately applicable implementing acts in accordance with the procedure provided for in 
Article 255(3). 

Article 51 
Confidentiality of information concerning the Union antigen, vaccine and diagnostic reagent 
banks 

Information  on  the  quantities  and  subtypes  of  the  biological  products  referred  to  in  Article 
48(1)  stored  in  the  Union  antigen,  vaccine  and  diagnostic  reagent  banks  shall  be  treated  as 
classified information and shall not be published. 

Article 52 
National antigen, vaccine and diagnostic reagent banks 

1. 

Member States that have established national antigen, vaccine and diagnostic reagent 
banks  for  listed  diseases  referred  to  in  Article  8(1)(a)  for  which  Union  antigen, 
vaccine  and  diagnostic  reagent  banks  exist,  shall  ensure  that  their  national  antigen, 
vaccine and diagnostic reagent banks comply with the biosecurity, biosafety and bio-
containment requirements provided for in Article 15(1)(a) and delegated acts adopted 
in accordance with Article 15(2) and Article 48(3)(b).  

2. 

Member States shall provide the Commission and the other Members States with up-
to-date information on:  

(a) 

(b) 

the  existence  or  the  establishment  of  national  antigen,  vaccine  and  diagnostic 
reagent banks referred to paragraph 1; 

the  types  of  antigens,  vaccines,  vaccine  master  seed  stocks  and  diagnostic 
reagents and their quantities in such banks; 

(c) 

any changes in their operation.  

3. 

The Commission may, by means of implementing acts, lay down rules specifying the 
content, frequency, and format of the submission of the information provided for in 
paragraph 2 of this Article. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2).  

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TITLE II 
Disease control measures 

Chapter 1 
Listed diseases referred to in Article 8(1)(a) 

SECTION 1 
DISEASE CONTROL MEASURES IN THE EVENT OF SUSPICION OF A LISTED 
DISEASE IN KEPT ANIMALS 

1. 

2. 

1. 

2. 

Article 53  
Obligations of operators, animal professionals and pet keepers 

In  the  event  of  suspicion  of  a  listed  disease  referred  to  in  Article  8(1)(a)  in  kept 
animals,  animal  professionals,  operators  and  pet  keepers  shall,  in  addition  to 
notifying  the  signs  or  suspicion  to  the  competent  authority  and  veterinarians  in 
accordance with Article 16(1) and pending any disease control measures being taken 
by  the  competent  authority  in  accordance  with  Articles  54(1)  and  55(1),  take  the 
appropriate disease control measures provided for in Article 55(1)(c), (d) and (e) to 
prevent  the  spread  of  that  listed  disease  from  the  affected  animals,  establishments 
and locations under their responsibility to other animals or to humans. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning detailed rules for supplementing the disease control measures 
to be taken by the operators, animal professionals and pet keepers as provided for in 
paragraph 1 of this Article. 

Article 54 
Investigation by the competent authority in the event of suspicion of a listed disease 

The competent authority shall in the event of the suspicion of a listed disease referred 
to  in  Article  8(1)(a)  in  kept  animals,  conduct  without  delay  an  investigation  to 
confirm or rule out the presence of that listed disease. 

For  the  purpose  of  the  investigation  provided  for  in  paragraph  1,  the  competent 
authority shall, when appropriate, ensure that official veterinarians: 

(a) 

(b) 

carry out a clinical examination of a representative sample of the kept animals 
of listed species for that particular listed disease;  

take  appropriate  samples  from  those  kept  animals  of  listed  species  and  other 
samples for laboratory examination in laboratories designated for that purpose 
by the competent authority; 

(c) 

carry  out  laboratory  examination  to  confirm  or  rule  out  the  presence  of  the 
particular listed disease. 

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3. 

1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning detailed rules supplementing the rules for the investigation by 
the competent authority provided for in paragraph 1 of this Article. 

Article 55 
Preliminary disease control measures by the competent authority  

The competent authority shall in the event of a suspicion of a listed disease referred 
to  in  Article  8(1)(a)  in  kept  animals  carry  out  the  following  preliminary  disease 
control  measures  pending  the  results  of  the  investigation  provided  for  in  Article 
54(1) and the carrying out of the disease control measures in accordance with Article 
61(1): 

(a) 

place  the  establishment,  household,  food  and  feed  business  or  animal  by-
products  establishment,  or  any  other  location  where  the  disease  suspicion 
occurs under official surveillance; 

(b) 

compile an inventory of:  

(i) 

(ii) 

the kept animals in the establishment, household, food and feed business 
or animal by-products establishment, or any other location;  

the  products  in  the  establishment,  household,  food  and  feed  business  or 
animal  by-products  establishment,  or  any  other  location,  where  relevant 
for the spread of that listed disease; 

(c) 

apply  appropriate  biosecurity  measures  to  prevent  the  spreading  of  that  listed 
disease agent to other animals or to humans; 

(d)  when  appropriate  to  prevent  the  further  spread  of  the  disease  agent,  keep  the 
kept  animals  of  listed  species  for  that  listed  disease  isolated,  and  prevent 
contact with wildlife;  

(e) 

restrict  the  movements  of  kept  animals,  products  and,  if  appropriate,  people, 
vehicles  and  any  material  or  other  means  by  which  the  disease  agent  could 
have spread to or from the establishment, households, food and feed business 
establishments, animal by-products establishments or any other location where 
that listed disease is suspected, as far as necessary to prevent its spread of the 
listed disease; 

(f) 

take  any  other  necessary  disease  control  measures,  taking  into  account  the 
disease control measures provided for in Section 4, concerning:  

(i) 

the application of the investigation by the competent authority provided 
for in Article 54(1) and disease control measures  provided for in points 
(a) to (d) of this paragraph to other establishments, epidemiological units 
therein,  households,  food  and  feed  businesses  or  animal  by-products 
establishments;  

(ii) 

the  establishment  of  temporary  restricted  zones,  which  are  appropriate 
taking into account the disease profile; 

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(g) 

initiate the epidemiological enquiry provided for in Article 57(1); 

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning detailed rules supplementing those laid down in paragraph 1 
of  this  Article  as  regards  the  specific  and  detailed  disease  control  measures  to  be 
taken  depending  on  the  listed  disease  referred  to  in  Article  8(1)(a),  taking  into 
account the risks involved for:  

(a) 

the species or category of animals;  

(b) 

the type of production. 

Article 56 
Review and extension of the preliminary disease control measures 

The disease control measures provided for in Article 55(1) shall be: 

(a) 

reviewed by the competent authority, as appropriate, following the findings of:  

(i) 

the investigation provided for in Article 54(1);  

(ii) 

the epidemiological enquiry provided for in Article 57(1); 

(b) 

further extended to other locations as referred to in Article 55(1)(e), where necessary. 

SECTION 2 
EPIDEMIOLOGICAL ENQUIRY 

Article 57 
Epidemiological enquiry  

1. 

2. 

The  competent  authority  shall  carry  out  an  epidemiological  enquiry  in  event  of  the 
suspicion or confirmation of a listed disease referred to in Article 8(1)(a) in animals. 

The epidemiological enquiry provided for in paragraph 1 shall aim at: 

(a) 

identifying the likely origin of the listed disease and the means of its spread; 

(b) 

calculating the likely length of time that the listed disease has been present; 

(c) 

therein, 
identifying  contact  establishments  and  epidemiological  units 
households, food and feed business or animal by-products establishment or any 
other locations where animals of listed species for the suspected listed disease 
may have become infected, infested or contaminated; 

(d)  obtaining  information  on  the  movements  of  kept  animals,  persons,  products, 
vehicles,  any  material  or  other  means  by  which  the  disease  agent  could  have 
been  spread  during  the  relevant  period  preceding  the  notification  of  the 
suspicion or confirmation of the listed disease; 

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(e) 

obtaining  information  on  the  likely  spread  of  the  listed  disease  in  the 
surrounding  environment,  including  the  presence  and  distribution  of  disease 
vectors.  

SECTION 3 
DISEASE CONFIRMATION IN KEPT ANIMALS 

Article 58 
Official confirmation by the competent authority of a listed disease referred to in 
Article 8(1)(a)  

1. 

The  competent  authority  shall  base  an  official  confirmation  of  a  listed  disease 
referred to in Article 8(1)(a) on the following information: 

(a) 

the  results  of  the  clinical  and  laboratory  examinations  provided  for  in 
Article 54(2); 

(b) 

the epidemiological enquiry provided for in Article 57(1); 

(c) 

other available epidemiological data.  

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning the requirements to be fulfilled for the official confirmation 
referred to in paragraph 1of this Article. 

Article 59 
Lifting of preliminary disease control measures where the presence of the listed disease has 
been ruled out 

The  competent  authority  shall  continue  to  apply  the  preliminary  disease  control  measures 
provided for in Article 55(1) and Article 56, until the presence of the listed diseases referred 
to in Article 8(1)(a) has been ruled out based on the information referred to in Article 58(1) or 
rules adopted pursuant to Article 58(2). 

SECTION 4 
DISEASE CONTROL MEASURES IN THE EVENT OF DISEASE CONFIRMATION IN 
KEPT ANIMALS  

Article 60 
Immediate disease control measures to be taken by the competent authority  

In  the  event  of  official  confirmation  in  accordance  with  Article  58(1)  of  an  outbreak  of  a 
listed  disease  referred  to  in  Article  8(1)(a)  in  kept  animals,  the  competent  authority  shall 
immediately: 

(a) 

declare  the  affected  establishment,  household,  food  or  feed  business,  animal  by-
products establishment or other location as officially infected with that listed disease; 

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(b) 

(c) 

1. 

establish a restricted zone, as appropriate for that listed disease; 

implement  the  contingency  plan  provided  for  in  Article  43(1)  to  ensure  full 
coordination of the disease control measures. 

Article 61 
Affected establishments and other locations 

In  the  event  of  an  outbreak  of  a  listed  disease  referred  to  in  Article  8(1)(a)  in  kept 
animals  in  an  establishment,  household,  food  or  feed  business,  animal  by-products 
establishment or any other location, the competent authority shall immediately take 
one or more of the following disease control measures in order to prevent the further 
spread of that listed disease: 

(a)  movement  restrictions  for  persons,  animals,  products,  vehicles  or  any  other 
material or substance that may be contaminated and contribute to the spread of 
the listed disease; 

(b) 

(c) 

(d) 

(e) 

(f) 

the  killing  and  disposal  or  slaughtering  of  animals  that  may  be  contaminated 
and contribute to the spread of the listed disease;  

the  destruction,  processing,  transformation  or  treatment  of  products,  feed,  or 
any other substances, or the treatment of equipment, means of transport, plants 
or  plant  products,  or  water  which  may  be  contaminated,  as  appropriate  to 
ensure that any disease agent or vector of the disease agent is destroyed;  

the  vaccination  or  treatment  with  other  veterinary  medicinal  products  of  kept 
animals  in  accordance  with  Article  46(1)  and  any  delegated  acts  adopted 
pursuant to Article 47(1); 

the isolation, quarantine or treatment of animals and products that are likely to 
be contaminated and contribute to the spread of the listed disease;  

the  cleaning,  disinfection,  disinfestation  or  other  necessary  biosecurity 
measures to be applied to the affected establishment, household, food or feed 
business, animal by-products establishment or other locations to minimise the 
risk of spread of the listed disease; 

(g) 

the  taking  of  a  sufficient  number  of  appropriate  samples  needed  to  complete 
the epidemiological enquiry provided for in Article 57(1); 

(h) 

the laboratory examination of samples. 

2. 

When determining which of the disease control measures provided for in paragraph 1 
are appropriate to take, the competent authority shall take the following into account:  

(a) 

the disease profile; 

(b) 

the  type  of  production,  and  epidemiological  units  within  the  affected 
establishment,  household,  food  or  feed  business,  animal  by-products 
establishment or other location. 

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3. 

The  competent  authority shall only authorise the repopulation of the  establishment, 
household or any other location when:  

(a) 

(b) 

all appropriate disease control measures and laboratory examinations provided 
for in paragraph 1 have been successfully completed; 

a  sufficient  period  of  time  has  elapsed  to  prevent  re-contamination  of  the 
affected  establishment,  household,  food  or  feed  business,  animal  by-products 
establishment  and  other  location  with  the  listed  disease  that  caused  the 
outbreak referred to in paragraph 1.  

Article 62 
Epidemiologically linked establishments and locations  

1. 

2. 

3. 

The  competent  authority  shall  extend  the  disease  control  measures  provided  for  in 
Article 61(1) to other establishments, epidemiological units therein, households, food 
or  feed  businesses  or  animal  by-products  establishments,  or  any  other  location,  or 
means of transport where the epidemiological enquiry provided for in Article 57(1), 
or  the  results  of  clinical  or  laboratory  investigations  or  other  epidemiological  data 
give  reason  to  suspect  the  spread  to,  from  or  through  them  of  the  listed  disease 
referred to in Article 8(1)(a) for which such measures were taken. 

If  the  epidemiological  enquiry  provided  for  in  Article  57(1)  shows  that  the  likely 
origin of the listed disease referred to in Article 8(1)(a) is another Member State or it 
is likely that that listed disease has spread to another Member State, the competent 
authority shall inform that Member State. 

In  the  events  referred  to  in  paragraph  2,  the  competent  authorities  of  the  different 
Member  States  shall  cooperate  in  a  further  epidemiological  enquiry  and  in  the 
application of disease control measures. 

Article 63 
Delegating power for the disease control measures in affected and epidemiologically linked 
establishments and locations 

The Commission shall be empowered to adopt delegated acts in accordance with Article 253 
concerning  detailed  rules  on  the  disease  control  measures  to  be  taken  by  the  competent 
authority  in  accordance  with  Articles  61  and  62  in  affected  and  epidemiologically  linked 
establishments,  food  or  feed  businesses  or  animal  by-products  establishments  and  locations 
for any listed disease referred to in Article 8(1)(a). 

Those detailed rules shall cover the following matters: 

(a) 

(b) 

the  conditions  and  requirements  for  the  disease  control  measures,  provided  for  in 
Article 61(1)(a) to (e); 

the  procedures  for  cleaning,  disinfection  and  disinfestation  provided  for  in  of 
Article 61(1)(f), specifying, where appropriate the use of biocidal products for those 
purposes;  

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(c) 

(d) 

(e) 

1. 

2. 

3. 

4. 

the  conditions  and  requirements  for  sampling  and  laboratory  examination  provided 
for in Article 61(1)(g) to (h); 

the  detailed  conditions  and  requirements  of  repopulation  provided  for  in  Article 
61(3); 

the necessary disease control measures provided for in Article 62 to be carried out in 
epidemiologically linked establishments, locations and means of transport. 

Article 64 
Establishment of restricted zones by the competent authority 

The  competent  authority  shall  establish  a  restricted  zone  around  the  affected 
establishment, household, food or feed business, animal by-products establishment or 
other location where the outbreak of a listed disease referred to in Article 8(1)(a) in 
kept animals has occurred, where appropriate, taking into account:  

(a) 

the disease profile; 

(b) 

the geographical situation of the restricted zones; 

(c) 

the ecological and hydrological factors of the restricted zones;  

(d) 

the meteorological conditions; 

(e) 

the presence, distribution and type of vectors in the restricted zones; 

(f) 

the  results  of  the  epidemiological  enquiry  provided  for  in  Article  57(1)  and 
other studies carried out and epidemiological data; 

(g) 

the results of laboratory tests; 

(h) 

the disease control measures applied.  

The  restricted  zone  shall  include,  when  appropriate,  a  protection  and  surveillance 
zone of a defined size and configuration.  

The  competent  authority  shall  continuously  assess  and  review  the  situation  and, 
when  appropriate  in  order  to  prevent  the  spread  of  the  listed  disease  referred  to  in 
Article 8(1)(a): 

(a) 

adapt the boundaries of the restricted zone; 

(b) 

establish additional restricted zones. 

Where  the  restricted  zones  are  situated  in  the  territory  of  more  than  one  Member 
State,  the  competent  authorities  of  those  Member  States  shall  cooperate  in 
establishing the restricted zones provided for in paragraph 1.  

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  detailed  rules  for  the  establishment  and  amendment  of 
restricted zones, including protection or surveillance zones.  

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Article 65 
Disease control measures in a restricted zone 

1. 

The  competent  authority  shall  take  one  or  more  of  the  following  disease  control 
measures  in  the  restricted  zone  in  order  to  prevent  the  further  spread  of  the  listed 
disease referred to in Article 8(1)(a):  

(a) 

the  identification  of  establishments,  households,  food  or  feed  businesses, 
animal  by-products  establishments  or  other  locations  with  kept  animals  of 
listed species for that listed disease; 

(b)  visits  to  establishments,  households,  food  or  feed  businesses,  animal  by-
products  establishments  or  other  locations  with  kept  animals  of  listed  species 
for  that  listed  disease,  and  where  necessary  examinations,  sampling  and 
laboratory examination of the samples;  

(c)  movement  conditions  for  the  movement  of  persons,  animals,  products,  feed, 
vehicles  and  any  other  material  or  substance  that  may  be  contaminated  or 
contribute  to  the  spread  of  that  listed  disease  within  and  from  the  restricted 
zones and transport through the restricted zones; 

(d)  biosecurity requirements for:  

(i) 

the production, processing and distribution of products of animal origin;  

(ii) 

the collection and disposal of animal by-products;  

(iii)  artificial insemination. 

(e) 

the vaccination and treatment with other veterinary medicinal products of kept 
animals  in  accordance  with  Article  46(1)  and  any  delegated  acts  adopted 
pursuant to Article 47(1);  

(f) 

cleaning, disinfection and disinfestation;  

(g) 

(h) 

(i) 

the  designation  or  where  relevant,  approval  of  a  food  business  establishment 
for the purposes of the slaughtering of animals or the treatment of products of 
animal origin originating from the restricted zones; 

the  identification  and  traceability  requirements  for  the  movement  of  animals, 
germinal products or products of animal origin; 

other necessary biosecurity and risk mitigating measures to minimise the risks 
of the spread of that listed disease. 

2. 

3. 

The competent authority shall take all necessary measures to fully inform the persons 
in  the  restriction  zones  of  the  restrictions  in  force  and  the  nature  of  the  disease 
control measures.  

When determining which of the disease control measures provided for in paragraph 1 
are to be taken, the competent authority shall take the following into account:  

(a) 

the disease profile; 

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(b) 

the types of production; 

(c) 

the feasibility, availability and effectiveness of those disease control measures.  

Article 66 
Operators obligations in restricted zones 

1. 

2. 

Operators keeping animals and products in the restricted zone provided for in Article 
64(1)  shall  notify  any  intended  movement  of  kept  animals  and  products,  within  or 
out of the restricted zone, to the competent authority. 

They  shall  only  move  the  kept  animals  and  products  in  accordance  with  the 
instructions of the competent authority.  

Article 67 
Delegation of powers concerning the disease control measures in restricted zones  

The Commission shall be empowered to adopt delegated acts in accordance with Article 253, 
concerning  detailed  rules  on  the  disease  control  measures  to  be  taken  in  a  restricted  zone 
provided for in Article 65(1) for each listed disease referred to in Article 8(1)(a).  

Those detailed rules shall cover the following matters: 

(a) 

(b) 

(c) 

(d) 

the  conditions  and  requirements  for  the  disease  control  measures,  provided  for  in 
Article 65(1) (a), (c), (d), (e), (g), (h) and (i); 

for 
the  procedures 
in Article 65(1)(f),  specifying,  where  appropriate  the  use  of  biocidal  products  for 
those purposes; 

for  cleaning,  disinfection  and  disinfestation  provided 

the necessary surveillance which is to be conducted following the application of the 
disease  control  measures  and  laboratory  examinations  provided  for  in  Article 
65(1)(b); 

other specific disease control measures to limit the spread of specific listed diseases 
referred to in Article 8(1)(a). 

Article 68 
Maintaining disease control measures in restricted zones and delegated acts 

1. 

The  competent  authority  shall  continue  to  apply  the  disease  control  measures 
provided for in this Section until: 

(a) 

(b) 

the  disease  control  measures,  appropriate  to  the  listed  disease  referred  to  in 
Article 8(1)(a) for which the restrictions were applied have been carried out; 

the  final  cleaning,  disinfection  or  disinfestation  has  been  carried  out  as 
appropriate for: 

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(i) 

the  listed  disease  referred  to  in  Article  8(1)(a)  for  which  the  disease 
control measures have been applied;  

(ii) 

the affected species of kept animals;  

(iii) 

the type of production;  

(c) 

adequate surveillance, as appropriate for the listed disease referred to in Article 
8(1)(a) for which the disease control measures have been applied, and the type 
of  establishment  or  location  has  been  carried  out  in  the  restricted  zone 
substantiating the eradication of that listed disease.  

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning detailed rules for the disease control measures to be taken by 
the competent authority as provided for in paragraph 1 of this Article in relation to:  

(a) 

(b) 

(c) 

the  final  cleaning,  disinfection  or  disinfestation  procedures,  and  where 
appropriate the use of biocidal products for those purposes; 

the  design,  means,  methods,  frequency,  intensity,  targeted  animal  population 
and  sampling  patterns  of  surveillance  to  regain  disease-free  status  after  the 
outbreak; 

the  repopulation  of  the  restricted  zones  after  the  completion  of  the  disease 
control  measures  provided  for  in  paragraph  1  of  this  Article,  taking  into 
account the conditions for repopulation provided for in Article 61(3);  

(d)  other  disease  control  measures  necessary  in  order  to  regain  the  disease-free 

status. 

Article 69 
Emergency vaccination 

Where  relevant  for  the  effective  control  of  the  listed  disease  referred  to  in  Article 
8(1)(a)  for  which  the  disease  control  measures  due  to  the  outbreak  apply,  the 
competent authority may:  

(a) 

develop a vaccination plan; 

(b) 

establish vaccination zones.  

The  competent  authority  shall,  when  deciding  on  the  vaccination  plan  and  the 
establishment of vaccination zones provided for in paragraph 1 of this Article, take 
the following into account: 

(a) 

(b) 

the  requirements  for  emergency  vaccination  provided  for  in  the  contingency 
plans provided for in Article 43(1); 

the requirements for the use of vaccines provided for in Article 46(1) and any 
delegated acts adopted pursuant to Article 47(1). 

1. 

2. 

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3. 

Vaccination  zones  provided  for  in  paragraph 1(b)  of  this  Article  shall  comply  with 
the requirements on risk mitigating measures to prevent the spread of listed diseases 
and  surveillance  as  laid  down  in  any  delegated  acts  adopted  in  accordance  with 
Article 47(1)(d) and (e). 

SECTION 5 
WILD ANIMALS 

Article 70 
Wild animals 

1. 

In the event of the suspicion or official confirmation of a listed disease referred to in 
Article 8(1)(a) in wild animals, the affected Member State shall: 

(a) 

(b) 

conduct,  where  relevant  for  that  particular  listed  disease,  surveillance  in  the 
wild animal population;  

take the necessary disease prevention and control measures to avoid the further 
spread of that listed disease.  

2. 

The  disease  prevention  and  control  measures  provided  for  in  paragraph  1(b)  shall 
take the following matters into account: 

(a) 

the disease profile;  

(b) 

the affected wild animals;  

(c) 

the  disease  control  measures  to  be  taken  in  the  event  of  suspicion  or  official 
confirmation of a listed disease referred to in Article 8(1)(a) in restricted zones 
in kept animals pursuant to rules laid down in Sections 1 to 4.  

3. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning:  

(a) 

surveillance pursuant to paragraph 1(a);  

(b)  disease prevention and control measures pursuant to paragraph 1(b). 

When  adopting  those  delegated  acts,  the  Commission  shall  take  into  consideration 
the disease profile and the listed species for the listed disease referred to paragraph 1. 

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SECTION 6 
ADDITIONAL DISEASE CONTROL MEASURES BY THE MEMBER STATES, 
COORDINATION BY THE COMMISSION AND TEMPORARY SPECIAL DISEASE 
CONTROL RULES 

Article 71 
Additional disease control measures by the Member States, coordination of measures by the 
Commission and temporary special disease control rules concerning Sections 1 to 5 

1. 

Member States may take additional disease control measures to those provided for in 
Article  61(1),  Article  62,  Article  65(1)  and  (2)  and  Article  68(1)  and  in  delegated 
acts  adopted  pursuant  to  Article  67  and  Article  68(2),  provided  that  such  measures 
are  in  line  with  the  rules  laid  down  in  this  Regulation  and  they  are  necessary  and 
proportionate to control the spread of the listed disease referred to in Article 8(1)(a), 
taking into account:  

(a) 

the particular epidemiological circumstances;  

(b) 

the type of establishments, other locations and production;  

(c) 

the categories and species of animals involved;  

(d) 

economic or social conditions. 

2. 

Member States shall inform the Commission without delay of:  

(a) 

the disease control measures taken by the competent authority as provided for 
in Articles 58, 59, 61, 62, 64 and 65, Article 68(1), Article 69 and Article 70(1) 
and (2) and delegated acts adopted pursuant to Articles 63 and 67 and Articles 
68(2) and 70(3);  

(b) 

any  additional  disease  control  measures  taken  by  it  as  provided  for  in 
paragraph 1. 

3. 

The Commission shall review the disease situation and the disease control measures 
taken by the competent authority and any additional disease control measures taken 
by  the  Member  State,  in  accordance  with  this  Chapter  and  may,  by  means  of 
implementing acts, lay down special disease control measures for a limited period of 
time, under conditions appropriate to the epidemiological situation, where: 

(a) 

(b) 

those  disease  control  measures  are  found  not 
epidemiological situation;  

to  be  suited 

to 

the 

the listed disease referred to in Article 8(1)(a) appears to be spreading despite 
the disease control measures taken in accordance with this Chapter. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2). 

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4. 

On duly justified imperative grounds of urgency relating to a disease representing an 
emerging risk of highly significant impact the Commission shall adopt immediately 
applicable  implementing  acts  in  accordance  with  the  procedure  referred  to  in 
Article 255(3). 

Chapter 2 
Listed diseases referred to in Article 8(1)(b) and (c) 

SECTION 1 
DISEASE CONTROL MEASURES IN THE EVENT OF SUSPICION OF DISEASE IN KEPT 
ANIMALS 

1. 

2. 

1. 

2. 

Article 72 
Obligations of operators, animal professionals and pet keepers 

In  the  event  of  suspicion  of  listed  diseases  referred  to  in  Article  8(1)(b)  and  (c)  in 
kept  animals,  operators,  animal  professionals  and  pet  keepers  shall,  in  addition  to 
notifying  the  signs  and  suspicion  to  the  competent  authority  and  veterinarians  in 
accordance with Article 16(1) and pending any disease control measures being taken 
by the competent authority in accordance with Article 74(1), take appropriate disease 
control  measures  referred  to  in  Article  74(1)(a)  and  any  delegated  acts  adopted 
pursuant to Article 74(3) to prevent the spread of that listed disease from the affected 
animals, establishments and locations under their responsibility to other animals or to 
humans. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning detailed rules for supplementing the disease control measures 
to be taken by the operators, animal professionals and pet keepers as provided for in 
paragraph 1 of this Article. 

Article 73  
Investigation by the competent authority in the event of suspicion of a listed disease 

The  competent  authority  shall,  in  the  event  of  the  suspicion  of  a  listed  disease 
referred  to  in  Article  8(1)(b)  and  (c)  in  kept  animals,  conduct  without  delay  an 
investigation to confirm or rule out the presence of that listed disease. 

For  the  purpose  of  the  investigation  provided  for  in  paragraph  1,  the  competent 
authority shall, when appropriate, ensure that official veterinarians: 

(a) 

(b) 

carry out a clinical examination of a representative sample of the kept animals 
of listed species for that particular listed disease;  

take  appropriate  samples  from  the  kept  animals  of  listed  species  and  other 
samples for laboratory examination in laboratories designated for that purpose 
by the competent authority; 

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3. 

1. 

(c) 

carry  out  a  laboratory  examination  to  confirm  or  rule  out  the  presence  of  the 
particular listed disease. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  detailed  rules  supplementing  rules  for  the  investigation 
provided for in paragraph 1 of this Article. 

Article 74 
Preliminary disease control measures by the competent authority  

The competent authority shall, in the event of a suspicion of a listed disease referred 
to in Article 8(1)(b) or (c) in kept animals carry out the following preliminary disease 
control  measures,  pending  the  results  of  the  investigation  provided  for  in  Article 
73(1)  and  the  carrying  out  of  disease  control  measures  in  accordance  with  Article 
78(1) and (2): 

(a) 

(b) 

apply  disease  control  measures  to  limit  the  spread  of  that  listed  disease  from 
the affected territory, establishment, household, food or feed business, animal 
by-products establishment or other location; 

initiate  where  necessary,  an  epidemiological  enquiry,  taking  into  account  the 
rules for such investigation provided for in Article 57(1) and any rules adopted 
pursuant to Article 57(2). 

2. 

The  preliminary  disease  control  measures  provided  for  in  paragraph  1  shall  be 
appropriate  and  proportionate  to  the  risk  posed  by  the  listed  disease  referred  to  in 
Article 8(1)(b) or (c) taking into account the following: 

(a) 

the disease profile; 

(b) 

the kept animals affected; 

(c) 

(d) 

the health status of the Member State, zone, compartment or establishment in 
which that listed disease is suspected; 

the  preliminary  disease  control  measures  provided  for  in  Article  55(1)  and 
Article 56 and any delegated act adopted pursuant to Article 55(2). 

3. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  rules  supplementing  those  laid  down  in  paragraph  1  of  this 
Article,  while  taking  into  account  the  matters  referred  to  in  paragraph  2  of  this 
Article, as regards: 

(a) 

(b) 

the  preliminary  disease  control  measures  to  be  taken  to  prevent  the  spread  of 
the listed disease, as provided for in paragraph 1(a); 

the  application  of  the  preliminary  disease  control  measures  provided  for  in 
paragraph  1(a) 
therein, 
households, food or feed businesses and animal by-products establishments or 
other locations; 

to  other  establishments,  epidemiological  units 

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(c) 

the  establishment  of  temporary  restricted  zones,  which  are  appropriate  due  to 
the disease profile. 

Article 75 
Review and extension of the preliminary disease control measures 

The disease control measures provided for in Article 74(1) shall be: 

(a) 

(b) 

reviewed  by  the  competent  authority  as  appropriate  following  the  findings  of  the 
investigation  provided  for  in  Article  73(1)  and,  where  relevant  the  epidemiological 
enquiry provided for in Article 74(1)(b);  

further  extended  to  other  locations,  as  referred  to  in  Article  74(3)(b)  where 
necessary. 

SECTION 2 
DISEASE CONFIRMATION IN KEPT ANIMALS 

Article 76  
Official confirmation of disease by the competent authority 

1. 

The  competent  authority  shall  base  an  official  confirmation  of  a  listed  disease 
referred to in Article 8(1)(b) or (c) on the following information: 

(a) 

the  results  of  the  clinical  and  laboratory  examinations  provided  for  in 
Article 73(2); 

(b) 

the epidemiological enquiry provided for in Article 74(1)(b), where relevant; 

(c) 

other available epidemiological data.  

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning the requirements to be fulfilled for the official confirmation 
referred to in paragraph 1of this Article.  

Article 77 
Lifting preliminary disease control measures when disease occurrence is ruled out 

The  competent  authority  shall  continue  to  apply  the  preliminary  disease  control  measures 
provided for in Article 74(1) and Article 75 until the presence of the listed diseases referred to 
in Article 8(1)(b) or (c) has been ruled out in accordance with Article 76(1) or rules adopted 
pursuant to Article 76(2). 

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SECTION 3 
DISEASE CONTROL MEASURES IN THE EVENT OF DISEASE CONFIRMATION IN 
KEPT ANIMALS  

Article 78 
Disease control measures by the competent authority  

1. 

In  the  event  of  an  official  confirmation  in  accordance  with  Article  76(1)  of  an 
outbreak  of  a  listed  disease  referred  to  in  Article  8(1)(b)  in  kept  animals  the 
competent authority shall: 

(a) 

(b) 

in a Member State, zone or compartment subject to a compulsory eradication 
programme  provided  for  in  Article  30(1)  for  that  listed  disease,  apply  the 
disease control measures laid down in that compulsory eradication programme; 

in  a  Member  State,  area,  zone  or  compartment  that  is  not  yet  subject  to  a 
compulsory eradication programme provided for in Article 30(1) for that listed 
disease, initiate that compulsory eradication programme and apply the disease 
control measures laid down therein. 

2. 

In  the  event  of  an  official  confirmation  in  accordance  with  Article  76(1)  of  an 
outbreak  of  a  listed  disease  referred  to  in  Article  8(1)(c)  in  kept  animals  the 
competent authority shall: 

(a) 

(b) 

in  a  Member  State,  zone  or  compartment  subject  to  a  voluntary  eradication 
programme  provided  for  in  Article  30(2)  for  that  listed  disease,  apply  the 
disease control measures laid down in that voluntary eradication programme; 

in a Member State, area, zone or compartment that is not subject to a voluntary 
eradication  programme  provided  for  in  Article  30(2)  for  that  listed  disease, 
apply, when appropriate, measures to control and prevent its spread. 

3. 

The measures provided for in paragraph 2(b) of this Article shall be proportionate to 
the  risk  posed  by  the  listed  disease  referred  to  in  Article  8(1)(c)  in  question  taking 
into account: 

(a) 

the disease profile; 

(b) 

the kept animals affected; 

(c) 

(d) 

the  health  status  of 
establishment in which the listed disease has been officially confirmed; 

the  Member  State,  area,  zone,  compartment  or 

the disease control measures to be taken in the establishments, other locations 
and restricted zones provided for in Section 4 of Chapter 1 of this Title.  

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Article 79 
Delegation of powers for the disease control measures to be taken by the competent authority 

The Commission shall be empowered to adopt delegated acts in accordance with Article 253 
laying down detailed rules concerning the disease control measures to be taken in the event of 
outbreaks of a listed disease referred to in Article 8(1)(b) or (c) in kept animals as provided 
for in Article 78(2)(b) taking into account the criteria provided for in Article 78(3). 

SECTION 4 
WILD ANIMALS  

Article 80 
Wild animals 

1. 

In  the  event  of  suspicion  or  official  confirmation  of  a  listed  disease  referred  to  in 
Article 8(1)(b) in wild animals, the competent authority of the affected Member State 
shall: 

(a) 

(b) 

in  the  entire  territory  of  the  Member  State,  area  or,  zone  subject  to  a 
compulsory eradication programme provided for in Article 30(1) for that listed 
disease,  apply  the  disease  control  measures  laid  down  in  that  compulsory 
eradication programme; 

in the entire territory of the Member State, area or zone that is not subject to a 
compulsory eradication programme provided for in Article 30(1) for that listed 
disease, initiate that compulsory eradication programme and apply the disease 
control  measures  laid  down  therein  where  appropriate,  to  control  and  prevent 
its spread. 

2. 

In the  event  of an outbreak of a listed disease referred to in Article 8(1)(c) in wild 
animals the competent authority of the affected Member State shall: 

(a) 

(b) 

in the entire territory of the Member State, area, zone or compartment subject 
to  a  voluntary  eradication  programme  provided  for  in  Article  30(2)  for  that 
listed  disease,  apply  the  disease  control  measures  laid  down  in  that  voluntary 
eradication programme; 

in the entire territory of the a Member State, area, zone or compartment that is 
not  subject  to  an  voluntary  eradication  programme  provided  for  in  Article 
30(2) for that listed disease, apply, when appropriate, measures to control and 
prevent its spread. 

3. 

The disease control measures  referred to in paragraph 2(b) shall take the following 
matters into account: 

(a) 

the disease profile;  

(b) 

the affected wild animals;  

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(c) 

the  disease  control  measures  to  be  taken  in  the  event  of  suspicion  or  official 
confirmation of a listed disease in restricted zones in kept animals pursuant to 
rules laid down in Sections 1 to 4 of Chapter 1 of this Title.  

4. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning detailed rules supplementing the disease control measures to 
be taken in the event of outbreaks of a listed disease referred to in Article 8(1)(b) or 
(c) in wild animals as provided for in paragraph 2(b) of this Article. 

SECTION 5 
COORDINATION BY THE COMMISSION AND TEMPORARY SPECIAL DISEASE 
CONTROL RULES 

Article 81 
Coordination of measures by the Commission and temporary special rules concerning 
Sections 1 to 4 

1. 

2. 

Member  States  shall  inform  the  Commission  of  the  disease  control  measures  taken 
by the competent authority in respect of a listed disease referred to in Article 8(1)(b) 
or (c), in accordance with Article 76(1), Articles 77 and 78 and Article 80(1) and (2) 
and delegated acts adopted pursuant to Article 76(2), Article 79 and Article 80(4).  

The Commission shall review the disease situation and the disease control measures 
taken by the competent authority in accordance with this Chapter and may, by means 
of  implementing  acts,  lay  down  special  rules  for  disease  control  measures  for  a 
limited period of time in respect of a listed disease referred to in Article 8(1)(b) and 
(c), under conditions appropriate to the epidemiological situation, where: 

(a) 

(b) 

those disease control measures taken by the competent authority are found not 
to be suited to the epidemiological situation;  

that listed disease referred to in Article 8(1)(b) or (c) appears to be spreading 
despite  the  disease  control  measures  taken  in  accordance  with  this  Chapter, 
where relevant. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2). 

3. 

On duly justified imperative grounds of urgency relating to a listed disease referred 
to  in  Article  8(1)(b)  and  (c)  representing  an  emerging  risk  of  highly  significant 
impact  the  Commission  shall  adopt  immediately  applicable  implementing  acts  in 
accordance with the procedure referred to in Article 255(3). 

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PART IV 
REGISTRATION, APPROVAL, TRACEABILITY AND 
MOVEMENTS 

TITLE I 
Terrestrial animals, germinal products and products of animal 
origin from terrestrial animals 

Chapter 1 
Registration, approval, record keeping and registers 

SECTION 1 
REGISTRATION OF ESTABLISHMENTS AND TRANSPORTERS 

Article 82 
Obligation of operators to register establishments  

1. 

Operators  of  establishments  keeping  terrestrial  animals  or  collecting,  producing, 
processing or storing germinal products shall, in order to be registered in accordance 
with Article 88, before they commence such activities:  

(a) 

inform  the  competent  authority  of  any  such  establishment  under  their 
responsibility; 

(b)  provide the competent authority with information on: 

(i) 

the name and address of the operator; 

(ii) 

the location and a description of the facilities; 

(iii) 

the categories, species and numbers of kept terrestrial animal or germinal 
products on the establishment and the capacity of the establishment; 

(iv) 

the type of establishment; 

(v)  other aspects of the establishment, which are relevant in determining the 

risk posed by it.  

2. 

Operators  of  establishments  referred  to  in  paragraph  1  shall  inform  the  competent 
authority of any: 

(a) 

significant  changes  in  the  establishment  concerning  the  matters  referred  to  in 
paragraph 1(b); 

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(b) 

cessation of activity in the establishment. 

3. 

Establishments which are subject to approval in accordance with Article 89(1) shall 
not be required to provide the information referred to in paragraph 1 of this Article. 

Article 83 
Derogations from the obligation of operators to register establishments  

By  way  of  derogation  from  Article  82(1),  Member  States  may  exempt  certain  categories  of 
establishments from the registration requirement, taking into account the following criteria: 

(a) 

(b) 

(c) 

the categories, species and numbers of kept terrestrial animals and germinal products 
on the establishment and the capacity of the establishment; 

the type of establishment;  

the  movements  of  kept  terrestrial  animals  or  germinal  products  into  and  out  of  the 
establishment.  

Article 84 
Implementing powers concerning the obligation of operators to register establishments 

The Commission may, by means of implementing acts, lay down rules concerning: 

(a) 

(b) 

the information to be provided by operators for the purpose of the registration of the 
establishments as provided for in Article 82(1); 

the  types  of  establishments  that  may  be  exempted  by  the  Member  States  from  the 
registration  requirement  in  accordance  with  Article  83  provided  that  those 
establishments pose an insignificant risk and taking into account the criteria provided 
for in that Article.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 255(2). 

Article 85 
Registration obligations of transporters of kept ungulates and delegated acts 

1. 

Transporters  of  kept  ungulates,  transporting  those  animals  between  Member  States 
shall in order to be registered in accordance with Article 88, before they commence 
such activities:  

(a) 

inform the competent authority of their activity; 

(b)  provide the competent authority with information on: 

(i) 

the name and address of the transporter; 

(ii) 

the  categories,  species  and  numbers  of  kept 
transported; 

terrestrial  animals 

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(iii) 

the type of transport; 

(iv) 

the means of transport.  

2. 

Transporters shall inform the competent authority of any: 

(a) 

significant changes concerning the matters referred to in paragraph 1(b); 

(b) 

cessation of the transport activity. 

3. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  supplementing  and  amending  the  rules  provided  for  in 
paragraph  1  concerning  the  obligation  of  other  types  of  transporters  to  provide  the 
information  for  the  purposes  of  registration  of  its  activity,  taking  into  account  the 
risks involved with such transports. 

Article 86 
Derogations from the obligation to register transporters of kept ungulates  

By  way  of  derogation  from  Article  85(1),  Member  States  may  exempt  certain  categories  of 
transporters from the registration requirement, taking into account the following criteria: 

(a) 

(b) 

the distances over which they transport those kept terrestrial animals;  

the categories, species and number of kept terrestrial animals, which they transport. 

Article 87 
Implementing acts concerning the obligation to register transporters 

The Commission shall be empowered to adopt implementing acts concerning: 

(a) 

(b) 

the information to be provided by the transporter for the purposes of registration of 
its activity, as provided for in Article 85(1); 

the  types  of  transporters  that  may  be  exempted  by  the  Member  States  from  the 
registration  requirement  in  accordance  with  Article  86  provided  that  the  type  of 
transport poses an insignificant risk and taking into account the criteria provided for 
in that Article.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 255(2). 

Article 88 
Obligation of the competent authority concerning the registration of establishments and 
transporters 

The competent authority shall register:  

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(a) 

(b) 

establishments  in  the  register  of  establishments  and  transporters  provided  for  in 
Article  96(1),  where  the  operator  has  provided  the  information  required  in 
accordance with Article 82(1); 

transporters in that register of establishments and transporters provided for in Article 
96(1),  where  the  transporter  has  provided  the  information  required  in  accordance 
with Article 85(1). 

SECTION 2 
APPROVAL OF CERTAIN TYPES OF ESTABLISHMENTS  

Article 89 
Approval of certain establishments and delegated acts 

1. 

Operators  of  the  following  types  of  establishments  shall  apply  to  the  competent 
authority for approval in accordance with Article 91(1) and they shall not commence 
their activities until their establishment has been approved in accordance with Article 
92(1): 

(a) 

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

(b)  germinal product establishments for bovine, porcine, ovine, caprine and equine 
animals, from which germinal products of those animals are moved to another 
Member State; 

(c) 

(d) 

(e) 

hatcheries, from which hatching eggs or poultry are moved to another Member 
State; 

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

any  other  type  of  establishment  for  kept  terrestrial  animals  which  poses  a 
significant  risk  and  is  required  to  be  approved  in  accordance  with  rules  laid 
down  in  a  delegated  act  adopted  in  accordance  with  paragraph  3(b)  of  this 
Article. 

2. 

Operators shall cease activity at an establishment referred to in paragraph 1 where:  

(a) 

(b) 

the competent authority withdraws or suspends its approval in accordance with 
Article 95(2); or  

in the event of conditional approval, granted in accordance with Article 94(3), 
the establishment fails to comply with the outstanding requirements referred to 
in Article 94(3) and does not obtain a final approval in accordance with Article 
92(1).  

3. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  supplementing  and  amending  the  rules  for  the  approval  of 
establishments provided for in paragraph 1 of this Article concerning: 

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(a) 

(b) 

(c) 

derogations from the requirement for operators of the types of establishments 
referred  to  in  paragraph  1(a)  to  (d)  to  apply  to  the  competent  authority  for 
approval  by  the  competent  authority,  where  those  establishments  pose  an 
insignificant risk; 

the  types  of  establishments  which  must  be  approved  in  accordance  with 
paragraph 1(e); 

special rules for the cessation of activities for germinal product establishments 
referred to in paragraph 1(b). 

4. 

The  Commission  shall  take  the  following  criteria  into  account,  when  adopting 
delegated acts provided for in paragraph 3: 

(a) 

(b) 

the categories and species of kept terrestrial animals or germinal products in an 
establishment;  

the  number  of  species  and  number  of  kept  terrestrial  animals  or  germinal 
products kept in an establishment;  

(c) 

the type of establishment and type of production; 

(d) 

the movements of kept terrestrial animals or germinal products into and out of 
those types of establishments. 

Article 90 
Approval of status of confined establishments  

Operators of establishments, who want to obtain the status of confined establishment shall: 

(a) 

(b) 

apply to the competent authority for approval in accordance with Article 91(1); 

not  move  kept  animals  to  a  confined  establishment  in  accordance  with  the 
requirements  provided  for  in  Article  134(1)  and  any  delegated  acts  adopted  in 
accordance with Article 134(2) until their establishment obtains an approval of that 
status by the competent authority in accordance with Articles 92 and 94.  

Article 91 
Information obligation of operators in view to obtaining approval and implementing acts 

1. 

Operators  shall  for  the  purposes  of  their  application  for  the  approval  of  their 
establishment provided for in Article 89(1) and Article 90(a), provide the competent 
authority with information on: 

(a) 

the name and address of the operator; 

(b) 

the location of the establishment and a description of the facilities; 

(c) 

the  categories,  species  and  numbers  of  kept  terrestrial  animals  or  germinal 
products on the establishment; 

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(d) 

the type of establishment; 

(e) 

other aspects of the establishment, related to its specificity, which are relevant 
in determining the risk posed by it.  

2. 

Operators  of  establishments  referred  to  in  paragraph  1  shall  inform  the  competent 
authority of any: 

(a) 

significant changes in the establishments concerning the matters referred to in 
paragraph 1(a), (b) and (c); 

(b) 

the cessation of activity in the establishment. 

3. 

The  Commission  may,  by  means  of  implementing  acts,  lay  down  rules  concerning 
the information to be provided by the operators in their application for the approval 
of their establishment in accordance with paragraph 1 of this Article.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2). 

Article 92 
Granting of and conditions for approval of establishments and delegated acts 

1. 

The competent authority shall only grant approval of establishments as provided for 
in Article 89(1) and Article 90(a) where such establishments: 

(a) 

comply with the following requirements, where appropriate, on:  

(i) 

(ii) 

quarantine, isolation and other biosecurity measures taking into account 
the  requirements  provided  for  in  Article  9(1)(b)  and  rules  adopted 
pursuant to Article 9(2);  

surveillance requirements provided for in Article 22, and where relevant 
for the type of establishment and the risk involved in Article 23 and the 
rules adopted pursuant to Article 24;  

(iii)  record keeping provided for in Articles 97 and 98 and the rules adopted 

pursuant to Articles 100 and 101; 

(b)  have facilities and equipment that are: 

(i) 

adequate to reduce the risk of the introduction and spread of diseases to 
an acceptable level, taking into account the type of establishment; 

(ii)  of adequate capacity for the number of kept terrestrial animals or volume 

of germinal products; 

(c) 

do not pose an unacceptable risk regarding the spread of diseases, taking into 
account the risk mitigation measures in place;  

(d)  have a sufficient number of adequately trained personnel for the activity of the 

establishment; 

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(e) 

have a system in place which enables the operator to demonstrate compliance 
with points (a) to (d) to the competent authority.  

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning the requirements provided for in paragraph 1 of this Article 
as regards: 

(a) 

quarantine,  isolation  and  other  biosecurity  measures  referred  to  in  paragraph 
1(a)(i); 

(b) 

surveillance referred to in paragraph 1(a)(ii); 

(c) 

facilities and equipment referred to in paragraph 1(b); 

(d) 

responsibilities,  competence  and  training  of  personnel  and  veterinarians 
provided for in paragraph 1(d); 

(e) 

the necessary supervision and control by the competent authority. 

3. 

The Commission shall take into account the following matters when establishing the 
rules to be laid down in the delegated acts to be adopted pursuant to paragraph 2: 

(a) 

the risks posed by each type of establishment; 

(b) 

the categories and species of kept terrestrial animals; 

(c) 

the type of production; 

(d) 

typical  movement  patterns  of  the  type  of  establishment  and  species  and 
categories of animals kept in those establishments. 

Article 93 
Scope of the approval of establishments 

The competent authority shall expressly specify in the approval of an establishment granted 
pursuant to Article 92(1) following an application made in accordance with Article 89(1) and 
Article 90(a): 

(a) 

(b) 

1. 

for which of the types of establishments referred to in Article 89(1), Article 90 and 
the rules adopted pursuant to 89(3)(b), the approval applies;  

for which categories and species of kept terrestrial animals or germinal products of 
those species the approval applies. 

Article 94 
Procedures for granting the approval by the competent authority  

The  competent  authority  shall  establish  procedures  for  operators  to  follow  when 
applying  for  approval  of  their  establishments  in  accordance  with  Articles  89(1), 
Article 90 and Article 91(1). 

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2. 

3. 

4. 

1. 

2. 

3. 

Upon  receipt  of  an  application  for  approval  from  an  operator,  the  competent 
authority shall, in accordance with Article 89(1)(a) and Article 90(a) make an on-site 
visit. 

The competent authority may grant conditional approval of an establishment where it 
appears, based on the application of the operator and the subsequent on-site visit of 
the establishment by the competent authority as provided for in paragraph 2 of this 
Article, that it meets all the main requirements that provide sufficient guarantees that 
such an establishment does not represent a significant risk, with a view to ensuring 
compliance with all the requirements for approval provided for in Article 92(1) and 
the rules adopted pursuant to Article 92(2).  

Where  conditional  approval  has  been  granted  by  the  competent  authority  in 
accordance with paragraph 3 of this Article, it shall grant full approval only where it 
appears  from  another  on-site  visit  of  the  establishment,  carried  out  within  three 
months of the date of granting conditional approval, that the establishment meets all 
the  requirements  for  approval  provided  for  in  Article  92(1)  and  the  rules  adopted 
pursuant to Article 92(2).  

Where  that  on-site  visit  shows  that  clear  progress  has  been  made  but  the 
establishment still does not meet all of those requirements, the competent authority 
may  prolong  the  conditional  approval.  However,  conditional  approval  shall  not 
exceed a total period of six months. 

Article 95 
Review, suspension and withdrawal of approvals by the competent authority 

The  competent  authority  shall  keep  the  approvals  of  establishments  granted  in 
accordance with Articles 92 and 94 under review. 

Where the competent authority identifies serious deficiencies in the establishment as 
regards  compliance  with  the  requirements  laid  down  in  Article  92(1)  and  the  rules 
adopted  pursuant  to  Article  92(2)  and  the  operator  is  not  able  to  provide  adequate 
guarantees  that  those  deficiencies  will  be  resolved,  the  competent  authority  shall 
initiate procedures to withdraw the establishment's approval.  

However,  the  competent  authority  may  suspend  an  establishment's  approval  where 
the operator can guarantee that it will resolve those deficiencies within a reasonable 
period of time. 

Approval  shall  only  be  restored  after  withdrawal  or  suspension  in  accordance  with 
paragraph  2  when  the  competent  authority  is  satisfied  that  the  establishment  fully 
complies  with  all  the  requirements  of  this  Regulation  appropriate  for  that  type  of 
establishment.  

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SECTION 3 
REGISTER OF THE COMPETENT AUTHORITY OF ESTABLISHMENTS AND 
TRANSPORTERS 

Article 96 
Establishment and transporter register 

1. 

The competent authority shall establish and keep up-to-date a register of:  

2. 

3. 

4. 

(a) 

all establishments and transporters registered pursuant to Article 88; 

(b) 

all establishments approved in accordance with Articles 92 and 94.  

It shall make that register available to other Member States and to the public.  

Where  appropriate  and  relevant,  the  competent  authority  may  combine  the 
registration referred to in paragraph 1(a) and approval referred to in paragraph 1(b) 
with registration for other purposes. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning:  

(a) 

the information to be included in the register provided for in paragraph 1; 

(b) 

additional requirements for registers of germinal products establishments, after 
they cease activities;  

(c) 

public availability of the register provided for in paragraph 1. 

The Commission may, by means of implementing acts, lay down rules on the format 
of  and  procedures  for  the  register  of  establishments  and  transporters  and  approved 
establishments provided for in paragraph 1 of this Article. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2).  

SECTION 4 
RECORD KEEPING 

Article 97 
Record keeping obligations of operators of establishments other than germinal products 
establishments  

1. 

Operators of establishments subject to registration in accordance with Article 88, or 
approval in accordance with Article 92(1) shall keep and maintain records containing 
at least the following information: 

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(a) 

(b) 

(c) 

the species, categories, numbers and identification of kept terrestrial animals on 
their establishment; 

the  movements  of  kept  terrestrial  animals  into  and  out  of  their  establishment, 
stating as appropriate: 

(i) 

their place of origin or destination;  

(ii) 

the date of such movements; 

the  documents  in  paper  or  electronic  form  required  to  accompany  kept 
terrestrial animals arriving at or leaving their establishment in accordance with 
Articles 106(b), 107(b), 109(c), 110(b), 113(b), Article 140(1) and (2), Article 
162(2)  and  rules  adopted  pursuant  to  Articles  114  and  117  and  Article 
141(1)(b) and (c); 

(d) 

any animal health problems concerning kept animals on their establishment; 

(e) 

biosecurity  measures,  surveillance,  treatments,  test  results  and  other  relevant 
information as appropriate for:  

(i) 

the category and species of kept terrestrial animals on the establishment;  

(ii) 

the type of production; 

(iii) 

the type and size of the establishment; 

(f) 

the results of any animal health visits required in accordance with Article 23(1) 
and rules adopted pursuant to Article 24. 

Establishments which are exempted from the registration requirement in accordance 
with Article 83 may be exempted by the Member State from the requirement to keep 
records of the information listed in paragraph 1 of this Article. 

Operators of establishments shall keep the records provided for in paragraph 1 on the 
establishment and: 

2. 

3. 

(a)  make them available to the competent authority on request; 

(b) 

retain them for a minimum period to be determined by the competent authority, 
but which may not be less than a period of three years. 

Article 98 
Record keeping for germinal product establishments 

1. 

Operators  of  germinal  product  establishments  shall  keep  and  maintain  records 
containing at least the following information: 

(a) 

the  breed,  age  and  identification  of  donor  animals  used  for  the  production  of 
germinal products; 

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(b) 

(c) 

(d) 

the  time  and  place  of  collection,  processing  and  storage  of  germinal  products 
collected, produced or processed; 

the identification of the germinal products together with details of their place of 
destination, if known; 

the  documents  in  paper  or  electronic  form  required  to  accompany  germinal 
products  arriving  at  or  leaving  the  establishment  in  accordance  with 
Article 159 and Article 162(2) and rules adopted pursuant to Article 160(3) and 
(4); 

(e) 

laboratory techniques used. 

2. 

3. 

Establishments which are exempted from the registration requirement in accordance 
with Article 84 may be exempted by the Member State from the requirement to keep 
records of the information listed in paragraph 1 of this Article. 

The operators of germinal product establishments shall keep the records provided for 
in paragraph 1 on the establishment and:  

(a)  make them available to the competent authority on request;  

(b) 

retain them for a minimum period to be determined by the competent authority, 
but which may not be less than a period of three years. 

Article 99 
Record keeping for transporters 

1. 

Transporters of germinal products shall keep and maintain records containing at least 
the following information: 

(a) 

the establishments visited by them;  

(b) 

the categories, species and number of germinal products transported by them; 

(c) 

the cleaning, disinfection and disinfestation of the means of transport. 

2. 

Transporters  which  are  exempted  from  the  registration  requirement  in  accordance 
with Article 86 may be exempted by the Member State from the requirement to keep 
records of the information listed in paragraph 1 of this Article. 

3. 

Transporters shall keep the records provided for in paragraph 1:  

(a) 

(b) 

in  a  manner  that  they  can  be  made  immediately  available  to  the  competent 
authority on request.  

for a minimum period to be determined by the competent authority, but which 
may not be less than a period of three years. 

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Article 100 
Delegation of powers concerning record keeping 

1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  rules  supplementing  the  record  keeping  requirements 
provided for in Articles 97, 98 and Article 99, as regards: 

(a) 

derogations from the record keeping requirements for:  

(i) 

operators  of  certain  types  of  establishments  and  certain  types  of 
transporters; 

(ii) 

establishments keeping, or transporters handling a small number of kept 
terrestrial animals or small volume of germinal products; 

(iii)  certain  categories  or  species  of  kept  terrestrial  animals  or  germinal 

products; 

(b) 

(c) 

information  to  be  recorded  in  addition  to  that  provided  for  in  Articles  97(1), 
98(1) and 99(1);  

additional  requirements  for  record  keeping  for  germinal  products  collected, 
produced or processed in a germinal products establishment, after they ceased 
their activities. 

2. 

The Commission shall take into account the following matters when establishing the 
rules to be laid down in delegated acts provided for in paragraph 1: 

(a) 

the risks posed by each type of establishment or transporter; 

(b) 

the  categories  and  species  of  kept  terrestrial  animals  or  germinal  products  in 
the establishment or transported; 

(c) 

the type of production on the establishment or the type of transport; 

(d) 

(e) 

the  typical  movement  patterns  of  the  type  of  establishment  and  category  of 
animals concerned; 

the number of kept terrestrial animals or volume of germinal products kept in 
the establishment or transported by the transporter.  

Article 101 
Implementing powers concerning record keeping 

The Commission shall by means of implementing acts, lay down rules concerning:  

(a) 

(b) 

the  format  of  records  provided  for  in  Articles  97(1),  98(1)  and  99(1)  and  rules 
adopted pursuant to Article 100; 

electronic  keeping  of  records  provided  for  in  Articles  97(1),  98(1)  and  99(1)  and 
rules adopted pursuant to Article 100; 

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(c) 

procedures  for  record  keeping  provided  for  in  Articles  97(1),  98(1)  and  99(1)  and 
rules adopted pursuant to Article 100. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 255(2).  

Chapter 2 
Traceability requirements for kept terrestrial animals and germinal 
products 

SECTION 1 
KEPT TERRESTRIAL ANIMALS 

Article 102 
Member States' responsibility for establishing a system for the identification and registration 
of kept terrestrial animals 

1. 

The Member States shall have in place a system for the identification and registration 
of  kept  terrestrial  animals  and,  when  appropriate,  for  the  recording  of  their 
movements, taking into account: 

(a) 

the species or category of kept terrestrial animals;  

(b) 

the risk posed by that species or category. 

2. 

The system provided for in paragraph 1 shall include the following elements: 

(a) 

the means to identify kept terrestrial animals individually or in groups; 

(b) 

identification  documents,  movement  documents  and  other  documents  for 
identifying and tracing kept terrestrial animals referred to in Article 104; 

(c) 

up-to-date records in establishments as provided for Article 97(1)(a) and (b);  

(d) 

a computer database of kept terrestrial animals provided for in Article 103(1).  

3. 

The system provided for in paragraph 1 shall be designed in a manner that it: 

(a) 

(b) 

(c) 

ensures the efficient application of the disease prevention and control measures 
provided for in this Regulation;  

facilitates  the  traceability  of  kept  terrestrial  animals  and  their  movements 
within and between Member States and their entry into the Union; 

ensures  the  efficient  interoperability,  integration  and  compatibility  of  the 
elements of that system; 

(d) 

ensures that the system, to the extent appropriate, is adapted to: 

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(i) 

the computerised information system for Union notification and reporting 
provided for in Article 20;  

(ii) 

IMSOC;  

(e) 

ensures  a  coherent  approach  for  the  different  animal  species  covered  by  the 
system.  

4. 

Member States may when appropriate:  

(a) 

(b) 

use  the  whole  or  part  of  the  system  provided  for  in  paragraph  1  for  purposes 
other than those referred to in paragraph 3(a) and (b); 

integrate  the  identification  documents,  movement  documents  and  other 
documents referred to in Article 104 with the animal health certificates or self- 
declaration document provided for in Article 140(1) and (2) and Article 148(1) 
and rules adopted pursuant to Article 141(b) and (c) and Article 148(3) and (4); 

(c) 

designate  another  authority  or  authorise  another  body  or  a  natural  person  for 
the practical application of the identification and registration system provided 
for in paragraph 1.  

Article 103 
Member States obligation for establishing a computer database of kept terrestrial animals 

1. 

The  Member  States  shall  establish  and  maintain  a  computer  database,  for  the 
recording of:  

(a) 

the  following  information  related  to  kept  animals  of  the  bovine,  ovine  and 
caprine species: 

(i) 

their  individual  identification  as  provided  for  in  Articles  106(a)  and 
107(a);  

(ii) 

the establishments keeping them; 

(iii) 

their movements into and from establishments;  

(b) 

information  related 
establishments keeping them; 

to  kept  animals  of 

the  porcine  species  and 

the 

(c) 

the following information related to kept animals of the equine species: 

(i) 

their unique life number as provided for in Article 109(1)(a); 

(ii) 

the  means  of  identification  linking  that  animal  with  the  identification 
document referred to in (iii), where relevant;  

(iii) 

the identification document provided for in Article 109(1)(c); 

(iv) 

the establishments where those animals are habitually kept; 

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(d) 

information  related  to  kept  terrestrial  animals  of  species  other  than  those 
referred  to  in  (a),  (b)  and  (c),  when  this  is  provided  for  in  rules  adopted 
pursuant to paragraph 2. 

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning the recording of information related to animal species other 
than  those  referred  to  in  paragraph  1(a),(b)  and  (c)  of  this  Article,  in  the  computer 
database  provided  for  in  that  paragraph  where  necessary,  taking  into  account  the 
risks posed by those species, to: 

(a) 

(b) 

ensure the efficient application of the disease prevention and control measures 
provided for in this Regulation; 

facilitate  the  traceability  of  kept  terrestrial  animals,  their  movements  within 
and between Member States and their entry into the Union.  

Article 104 
Obligation of the competent authority for identification documents, movement documents and 
other documents for identifying and tracing kept terrestrial animals 

The competent authority shall issue: 

(a) 

(b) 

identification  documents 
required  by 
Articles 106(b) and 109(c), Article 112(1)(b) and (2)(b), and Article 113(b) and rules 
adopted pursuant to Articles 114 and 117; 

terrestrial  animals  when 

for  kept 

movement documents and other documents for identifying and tracing kept terrestrial 
animals,  when  required  by  Articles  107(b),  110(b),  113(b)  and  rules  adopted 
pursuant to Articles 114 and 117. 

Article 105 
Public availability of information on means of identification 

The  competent  authority  shall  inform  the  Commission  and  make  publicly  available 
information on: 

(a) 

(b) 

(c) 

contact  points  for  the  computer  databases  established  by  the  Member  States  in 
accordance with Article 103(1); 

the authorities or bodies responsible for issuing identification documents, movement 
documents and other documents in accordance with Article 104, taking into account 
Article 102(4)(c); 

the means of identification that are to be used for each category and species of kept 
terrestrial  animals  in  accordance  with  Articles  106(a)  and  107(a),  Article  109(1), 
Article  110(a),  Article  112(1)(a)  and  (2)(a)  and  Article  113(a)  and  rules  adopted 
pursuant to Articles 114 and 117; 

(d) 

the  prescribed  format  for  the  issuing  of  the  identification  documents  and  other 
documents referred to in Article 104. 

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Article 106 
Operators obligations for the identification of kept animals of the bovine species 

Operators keeping animals of the bovine species shall: 

(a) 

(b) 

ensure  that  those  kept  animals  are  identified  individually  by  a  physical  means  of 
identification;  

ensure  that  those  kept  animals  are  issued  with  an  identification  document  from  the 
competent  authority  or  designated  authority  or  authorised  body,  which  is  a  single 
lifetime document and that that document:  

(i) 

is kept, correctly completed and updated by the operator; 

(ii) 

accompanies those kept terrestrial animals at the time of movement; 

(c) 

transmit  the  information  on  movements  of  those  kept  animals  from  and  into  the 
establishment to the computer database provided for in Article 103(1) and the rules 
adopted pursuant to Articles 114 and 117.  

Article 107 
Operators obligations for the identification of kept animals of the ovine and caprine species 

Operators keeping kept animals of the ovine and caprine species shall: 

(a) 

(b) 

(c) 

ensure  that  those  kept  animals  are  identified  individually  by  a  physical  means  of 
identification;  

ensure that those kept animals are accompanied by a correctly completed movement 
document  issued  by  the  competent  authority  in  accordance  with  Article 104  when 
moved from the establishment keeping those animals; 

transmit the information on movements from and into the establishment of those kept 
animals  to  the  computer  database  provided  for  in  Article  103(1)  and  the  rules 
adopted pursuant to Articles 114 and 117.  

Article 108 
Derogations concerning identification documents and movement documents for kept animals 
of the bovine, ovine and caprine species  

By way of derogation from Article 104 and from Articles 106(b) and 107(b), Member States 
may exempt operators from the requirement to ensure that kept animals of the bovine, ovine 
and  caprine  species  are  accompanied  by  identification  documents  or  movement  documents 
during movements within the Member State, provided that: 

(a) 

(b) 

the  information contained in  the movement document or identification document is 
included in the computer database provided for in Article 103(1); 

the system for the identification and registration of kept animals of the bovine, ovine 
and  caprine  species  provides  an  equivalent  level  of  traceability  as  that  provided  by 
identification documents and movements documents. 

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Article 109 
Operators obligations for the identification and registration of kept animals of the equine 
species 

1. 

Operators keeping kept animals of the equine species shall ensure that those animals 
are individually identified by: 

(a) 

(b) 

an unique life number, which is recorded in the computer database provided for 
in Article 103(1); 

a method which unequivocally links the kept animal and with the identification 
document  provided  for  in  point  (c)  of  this  paragraph  and  issued  by  the 
competent authority in accordance with Article 104;  

(c) 

a correctly completed single lifetime identification document. 

2. 

Operators  of  kept  animals  of  the  equine  species  shall  transmit  the  information  on 
those  animals  to  the  computer  database  provided  for  in  Article  103(1)  and  by  the 
rules adopted pursuant to Articles 114 and 117.  

Article 110 
Operators obligations for the identification and registration of kept l animals of the porcine 
species 

Operators keeping kept animals of the porcine species shall: 

(a) 

(b) 

(c) 

ensure that those kept animals are identified by a means of physical identification;  

ensure that those kept animals are accompanied by a correctly completed movement 
document issued by the competent authority in accordance with Article 104(b) when 
moved from the establishment keeping those animals; 

transmit  the  information  related  to  the  establishment  keeping  those  animals  to  the 
computer database provided for in Article 103(1) and in the rules adopted pursuant to 
Articles 114 and 117. 

Article 111 
Derogations concerning movements of kept animals of the porcine species 

By way of derogation from Article 110(b), the Member States may exempt operators from the 
requirement to ensure that kept animals of the porcine species are accompanied by correctly 
completed movement documents issued by the competent authority for movements within the 
Member State, provided that: 

(a) 

(b) 

the information on such movement documents is included in the computer database 
established by the Member State in accordance with Article 103(1); 

the  system  for  the  identification  and  registration  of  kept  terrestrial  animals  of  the 
porcine species provides an equivalent level of traceability as that provided by such 
movement documents. 

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Article 112 
Pet keepers' obligation for the identification and registration of terrestrial pet animals 

1. 

Pet keepers shall ensure that terrestrial pet animals of the species listed in Part A of 
Annex I which are moved from one Member State to another Member State: 

(a) 

are individually identified by a physical means of identification; 

(b) 

are accompanied by a correctly completed and updated identification document 
issued by the competent authority in accordance with Article 104. 

2. 

Pet keepers shall ensure that terrestrial pet animals of the species listed in Part B of 
Annex  I  when  moved  from  one  Member  State to another Member State, and when 
required by rules adopted pursuant to Articles 114 and 117, are: 

(a) 

identified, either individually or in groups; 

(b) 

accompanied  by  correctly  completed  and  updated  identification  documents, 
movement documents or other documents for identifying and tracing animals, 
as appropriate for the animal species concerned. 

Article 113 
Operators obligation for the identification of kept terrestrial animals other than animals of 
the bovine, ovine, caprine, porcine and equine species and pet animals 

Operators shall ensure that kept terrestrial animals of species other than those of the bovine, 
ovine,  caprine,  porcine  and  equine  species  and  other  than  pet  animals,  comply  with  the 
following requirements, when required by the rules adopted pursuant to Articles 114 and 117: 

(a) 

(b) 

they are identified, either individually or in groups; 

they are accompanied by correctly completed and updated identification documents, 
movement  documents  or  other  documents  for  identifying  and  tracing  animals,  as 
appropriate for the animal species concerned. 

Article 114 
Delegation of powers concerning identification and registration 

The Commission shall be empowered to adopt delegated acts in accordance with Article 253 
concerning: 

(a) 

the designation of other authorities, the authorisation of bodies or natural persons, as 
provided for in Article 102(4)(c);  

(b) 

detailed requirements for:  

(i) 

the  means  of  identification  of  kept  terrestrial  animals  provided  for  in 
Articles 106(a)  and  107(a),  Article  109(1),  Article  110(a),  Article  112(1)(a) 
and (2)(a), and Article 113(a);  

(ii) 

the application and use of that means of identification; 

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(c) 

the information to be included in:  

(i) 

the computer databases provided for in Article 103(1); 

(ii) 

the identification document for kept animals of the bovine species provided for 
in Article 105(b); 

(iii) 

the  movement  document  for  kept  animals  of  the  caprine  and  ovine  species 
provided for in Article 107(b); 

(iv) 

the identification document for kept animals of the equine species provided for 
in 109(1)(c); 

(v) 

the movement document for kept animals of the porcine species provided for in 
Article 110(b); 

(vi) 

in 
identification  documents 
Article 112(1)(b)  or  identification  documents,  movement  documents  or  other 
documents for kept terrestrial pet animals provided for in Article 112(2)(b);  

terrestrial  pet  animals  provided 

for 

for 

(d) 

(e) 

(f) 

(vii)  identification  documents  or  movement  documents  for  kept  terrestrial  animals 
other  than  animals  of  the  bovine,  ovine,  caprine,  porcine,  equine  species  and 
pet animals provided for in Article 113(b);  

detailed requirements for different species and categories of kept terrestrial animals 
to ensure the efficient operation of the identification and registration system provided 
for in Article 102(1);  

detailed  requirements  for  kept  terrestrial  animals  entering  the  Union  from  third 
countries and territories;  

identification  and  registration  requirements  for  kept  terrestrial  pet  animals  of  the 
species listed in Part B of Annex I and kept terrestrial animals of species other than 
the bovine, ovine, caprine, porcine and equine species where necessary, taking into 
account the risks posed by that species, to: 

(i) 

ensure the efficient application of the disease prevention and control measures 
provided for in this Regulation; 

(ii) 

facilitate  the  traceability  of  kept  terrestrial  animals,  and  their  movements 
within and between Member States and their entry into the Union. 

Article 115 
Delegation of powers concerning derogations from the traceability requirements 

The Commission shall be empowered to adopt delegated acts in accordance with Article 253 
concerning  derogations  for  operators  from  the  identification  and  registration  requirements 
provided for in Articles 106, 107 and 109 and 110: 

(a) 

in  cases  where  one  or  more  of  these  elements  are  not  necessary  to  meet  the 
requirements provided for in Article 102(3)(a) and (b);  

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(b) 

when  other  traceability  measures  in  place  in  the  Member  States  guarantee  that  the 
level of traceability of the animals in questions is not compromised. 

Article 116 
Matters to be taken into account when adopting delegated acts provided for in Articles 114 
and 115 

The Commission shall take the following matters into account, when establishing the rules to 
be laid down in the delegated acts provided for in Articles 114 and 115: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

the categories and species of kept terrestrial animals; 

the risks involved for those kept terrestrial animals;  

the number of animals in the establishment; 

the type of production in the establishments where those terrestrial animals are kept;  

movement patterns for the species and categories of kept terrestrial animals;  

considerations  concerning  the  protection  and  conservation  of  species  of  kept 
terrestrial animals;  

the performance of the other traceability elements of the system for the identification 
and registration of kept terrestrial animals referred to in Article 102(2). 

Article 117 
Implementing powers concerning traceability of kept terrestrial animals 

The Commission shall by means of implementing acts, lay down rules for the implementation 
the  requirements  provided  for  in  Articles  106,  107,  109,  110,  112  and  113  and  those  laid 
down  in  delegated  acts  adopted  pursuant  to  Article 103(2)  and  Articles  114  and  115 
concerning: 

(a) 

technical specifications, formats and operational rules of:  

(i)  means, methods and the use of identification; 

(ii) 

the  identification  document  or  movement  document  for  kept  animals  of  the 
bovine, ovine, caprine species; 

(iii) 

identification document for kept animals of the equine species; 

(iv) 

identification,  movement  and  other  documents  for  kept  terrestrial  animals  of 
species; other than of the bovine, ovine, caprine and equine species 

(v) 

computer databases. 

(b) 

the deadlines for:  

(i) 

the transmission of information by operators into the computer database;  

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(ii) 

the registration of kept terrestrial animals; 

(iii) 

identification  of  kept 

the 
identification marks; 

terrestrial  animals  and 

the  replacement  of 

(c) 

practical application of exemptions from the identification and registration provided 
for in the rules adopted pursuant to Article 115. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 255(2).  

SECTION 2 
GERMINAL PRODUCTS 

Article 118 
Traceability requirements for germinal products of kept animals of the bovine, ovine, caprine, 
equine and porcine species and poultry 

1. 

Operators  producing,  processing  or  storing  germinal  products  shall  mark  germinal 
products of kept animals of the bovine, caprine, ovine, equine and porcine species in 
such a way that they can be clearly traced to: 

(a) 

the donor animals; 

(b) 

the date of collection;  

(c) 

the  germinal  product  establishments  where  they  were  collected,  produced, 
processed and stored.  

2. 

The  marking  provided  for  in  paragraph  1  shall  be  designed  in  such  a  way  as  to 
ensure: 

(a) 

(b) 

the  efficient  application  of  the  disease  prevention  and  control  measures 
provided for in this Regulation;  

the  traceability  of  the  germinal  products  and  their  movements  within  and 
between Member States and their entry into the Union. 

Article 119 
Delegation power concerning traceability requirements for germinal products  

1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning: 

(a) 

traceability  requirements  for  germinal  products  of  kept  terrestrial  animals  of 
the  bovine,  caprine,  ovine,  porcine  and  equine  species  amending  and 
supplementing the rules laid down in Article 118; 

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(b) 

traceability  requirements  for  germinal  product  of  kept  terrestrial  animals  of 
species  other  than  of  the  bovine,  caprine,  ovine,  equine  and  porcine  species, 
where necessary for:  

(i) 

the  efficient  application  of  the  disease  prevention  and  control  measures 
provided for in this Regulation;  

(ii) 

the  traceability  of  those  germinal  products,  their  movements  within  and 
between Member States and their entry into the Union. 

2. 

The  Commission  shall  take  the  following  matters  into  account  when  adopting  the 
delegated acts provided for in paragraph 1: 

(a) 

the  species  of  kept  terrestrial  animals  from  which  the  germinal  products 
originate; 

(b) 

the health status of donor animals; 

(c) 

the risk involved with such germinal products; 

(d) 

the type of germinal products; 

(e) 

the type of collection, processing or storage;  

(f)  movement patterns for the species and categories of kept terrestrial animals and 

their germinal products;  

(g) 

considerations  concerning  the  protection  and  conservation  of  species  of  kept 
terrestrial animals; 

(h)  other elements that may contribute to the traceability of germinal products. 

Article 120 
Implementing powers concerning traceability requirements for germinal products  

The Commission shall, by means of implementing acts, lay down rules concerning:  

(a) 

(b) 

technical requirements and specifications for marking provided for in Article 118(1); 

operational requirements for the traceability requirements provided for in delegated 
acts adopted pursuant to Article 119(1). 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 255(2).  

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Chapter 3 
Movements within the Union of kept terrestrial animals other than 
terrestrial pet animals 

SECTION 1 
GENERAL REQUIREMENTS FOR MOVEMENTS 

Article 121 
General requirements for movements of kept terrestrial animals 

1. 

Operators shall take appropriate preventive measures to ensure that the movement of 
kept  terrestrial  animals  does  not  jeopardise  the  health  status  at  the  place  of 
destination with regard to:  

(a) 

the listed diseases referred to in Article 8(1)(d);  

(b) 

emerging diseases. 

2. 

Operators  shall  only  move  kept  terrestrial  animals  from  establishments  and  receive 
such animals, if they comply with the following conditions: 

(a) 

they come from establishments that have been: 

(i) 

entered  in  the  register  of  establishments  by  the  competent  authority  in 
accordance with Article 88(a) and no derogation has been granted by the 
Member State of origin in accordance with Article 83;  

(ii) 

approved  by  the  competent  authority  in  accordance  with  Article  92(1), 
when required by Article 89(1) or Article 90;  

(b) 

they  comply  with  the  identification  and  registration  requirements  of  Articles 
106, 107, 109, 110 and 113 and the rules adopted pursuant to Article 114(a) to 
(d) and Article 117. 

Article 122 
Preventive measures in relation to transport 

1. 

Operators  shall  take  the  appropriate  and  necessary  preventive  measures  to  ensure 
that: 

(a) 

the health status of kept terrestrial animals is not jeopardised during transport; 

(b) 

transport operations of kept terrestrial animals do not cause the potential spread 
of listed diseases referred to in Article 8(1)(d) to humans and animals at places 
of assembly, resting and destination;  

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(c) 

cleaning, disinfection, disinfestations of equipment and means of transport and 
other  adequate  biosecurity  measures  are  taken,  as  appropriate  to  the  risks 
involved with the transport. 

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning: 

(a) 

the  cleaning,  disinfection  and  disinfestations  of  equipment  and  means  of 
transport and the use of biocidal products for those purposes; 

(b)  other adequate biosecurity measures as provided for in paragraph 1(c).  

SECTION 2 
MOVEMENTS BETWEEN MEMBER STATES  

Article 123 
General requirements for movements of kept terrestrial animals between Member States 

1. 

Operators  shall  only  move  kept  terrestrial animals  to  another  Member  State  if  they 
comply with following conditions: 

(a) 

they come from an establishment:  

(i)  where there are no abnormal mortalities or other disease symptoms with 

an undetermined cause; 

(ii)  which is not subject to movement restrictions affecting the species to be 
moved  in  accordance  with  the  rules  laid  down  in  Articles  55(1)(d), 
61(1)(a), Article 62, Article 65(1)(c), Article 74(1) and Article 78(1) and 
(2)  and  the  rules  adopted  pursuant  to  Article  55(2),  Articles  63  and  67, 
Article  71(3),  Article  74(3),  Article  79  and  Article  81(2)  or  the 
emergency  measures  provided  for  in  Articles  246  and  247  and  rules 
adopted pursuant to Article 248, unless derogations have been granted for 
movement restrictions in accordance with those rules;  

(iii)  which  is  not  situated  in  a  restricted  zone  in  accordance  with  rules  laid 
down in Article 55(1)(f)(ii), Articles 64 and 65, Article 74(1), Article 78 
and  rules  adopted  pursuant  to  Article  67,  Article  71(3),  Article  74(3), 
Article 79 and Article 81(2) or the emergency measures provided for in 
Articles  246  and  247  and  rules  adopted  pursuant  to  Article  248,  unless 
derogations have been granted in accordance with those rules;  

(b) 

they have not been in contact with kept terrestrial animals subject to movement 
restrictions  referred  to  in  point  (a)(ii)  and  (iii)  or  kept  terrestrial  animals  of  a 
listed species of a lower health status, for an adequate period of time, prior to 
the  date  of  the  intended  movement  to  another  Member  State,  thereby 
minimising  the  possibility  of  spreading  disease,  taking  into  account  the 
following matters: 

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(i) 

the incubation period and routes of transmission of the listed diseases and 
emerging diseases;  

(ii) 

the type of establishment; 

(iii) 

the species and category of kept terrestrial animals moved;  

(iv)  other epidemiological factors; 

(c) 

they comply with the relevant requirements provided for in Sections 3 to 8. 

2. 

Operators  shall  take  all  necessary  measures  to  ensure  that  kept  terrestrial  animals 
moved to another Member State are consigned directly to their place of destination in 
another  Member  State  unless  they  need  to  stop  at  a  place  of  resting  for  animal 
welfare reasons. 

Article 124  
Obligations of operators at the place of destination 

1. 

Operators  of  establishments  and  slaughterhouses  receiving  kept  terrestrial  animals 
from another Member State shall:  

(a) 

check that:  

(i) 

(ii) 

the  means  of  identification  provided  for  in  Articles  106(a)  and  107(a), 
Article  109(1)  and  Articles110(a)  and  113(a)  and  the  rules  adopted 
pursuant to Articles 114 and 117 are present; 

the identification documents provided for in Articles 106(b) and 107(b), 
Article  109(1)(c),  Article  113(b)  and  the  rules  adopted  pursuant  to 
Articles 114 and 117 are present and are correctly completed;  

(b) 

check that the animal health certificates provided for in Article 140 and rules 
adopted  pursuant  to  Article  141(b)  and  (c)  or  the  self-declaration  documents 
provided for in Article 148 and the rules adopted pursuant to Article 148(2) are 
present;  

(c) 

inform the competent authority of any irregularity with regard to:  

(i) 

the kept terrestrial animals received; 

(ii) 

the presence of the means of identification referred to in point (a)(i); 

(iii) 

the documents referred to in point (a)(ii) and (b). 

2. 

In  the  event  of  any  irregularity  as  referred  to  in  paragraph  1(c),  the  operator  shall 
isolate  the  animals  concerned  by  that  irregularity  until  the  competent  authority  has 
taken a decision regarding them. 

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Article 125  
Prohibition on movements of kept terrestrial animals between Member States 

Operators shall not move kept terrestrial animals to another Member State, unless the Member 
State of destination gives express authorisation prior to the movement in the event of animals 
which  are  intended  to  be  slaughtered  for  disease  eradication  purposes  as  a  part  of  an 
eradication programme provided for in Article 30(1), (2) and (3). 

Article 126 
General requirements for operators for movements of kept terrestrial animals passing 
through Member States but intended for export from the Union to third countries or 
territories 

Operators  shall  ensure  that  kept  terrestrial  animals  intended  for  export  to  a  third  country  or 
territory and passing through the territory of another Member State fulfil the requirements laid 
down in Articles 121, 122, 123 and 125.  

SECTION 3 
SPECIFIC REQUIREMENTS FOR MOVEMENTS TO OTHER MEMBER STATES OF 
UNGULATES AND POULTRY 

Article 127 
Movement of kept ungulates and poultry to other Member States 

Operators shall only move kept ungulates and poultry from an establishment in one Member 
State to another Member State if they comply with following conditions as regards the listed 
diseases referred to in Article 8(1)(d): 

(a) 

(b) 

(c) 

(d) 

they  show  no  clinical  symptoms  or  signs  of  listed  diseases  referred  to  in  Article 
8(1)(d) at the time of movement; 

they  have  been  subject  to  a  residency  period  appropriate  to  those  listed  diseases 
taking  into  account  the  species  and  category  of  kept  ungulates  and  poutry  to  be 
moved; 

for a period of time appropriate for those listed diseases and the species and category 
of  ungulates  or  poultry  to  be  moved,  no  kept  ungulates  or  poultry  have  been 
introduced into the establishment of origin; 

they do not pose a significant risk for the spread of those listed diseases at the place 
of destination.  

Article 128 
Delegation of powers for movement of kept ungulates and poultry to other Member States 

1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning: 

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(a) 

residency periods provided for in Article 127(b); 

(b) 

(c) 

the period of time necessary for limiting the introduction of kept ungulates or 
poultry into establishments prior to movement provided for in Article 127(c); 

supplementary  requirements  to  ensure  that  the  kept  ungulates  and  poultry  do 
not pose a significant risk for the spread of listed diseases referred to in Article 
8(1)(d), as provided for in Article 127(d);  

(d)  other risk mitigating measures amending and supplementing the requirements 

laid down in Article 127.  

2. 

The Commission shall take the following matters into account, when establishing the 
rules to be laid down in the delegated acts provided for in paragraph 1:  

(a) 

(b) 

the listed diseases referred to in Article 8(1)(d) relevant for the listed species or 
the category of kept ungulates or poultry to be moved;  

the health status as regards listed diseases referred to in Article 8(1)(d) at the 
establishments,  compartments,  zones  and  Member  States  of  origin  and 
destination;  

(c) 

the type of establishment and the type of production at the places of origin and 
destination; 

(d) 

the type of movement;  

(e) 

the categories and species of kept ungulates or poultry to be moved;  

(f) 

the age of the kept ungulates or poultry to be moved; 

(g)  other epidemiological factors. 

Article 129 
Kept ungulates and poultry moved to another Member State and intended for slaughter 

1. 

2. 

Operators  of  slaughterhouses  receiving  kept  ungulates  and  poultry  from  another 
Member  State  shall  slaughter  those  animals  as  soon  as  possible  following  their 
arrival and at the latest within a timeframe to be laid down in delegated acts adopted 
pursuant to paragraph 2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  the  time  of  slaughter  provided  for  in  paragraph  1  of  this 
Article. 

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SECTION 4  
ASSEMBLY OPERATIONS FOR KEPT UNGULATES AND POULTRY 

Article 130 
Derogation for assembly operations 

1. 

By way of derogation from Article 123(2), operators may subject kept ungulates and 
poultry to a maximum of:  

(a) 

one assembly operation in the Member State of origin; 

(b)  one assembly operation in the Member State of passage;  

(c) 

one assembly operation in the Member State of destination.  

2. 

The assembly operations provided for in paragraph 1 of this Article shall only take 
place in an establishment approved for that purpose in accordance with Article 92(1) 
and Article 94(3) and (4).  

However,  the  Member  State  of  origin  may  allow  assembly  operations  in  their 
territory  to  take  place  on  means  of  transport,  collecting  kept  ungulates  and  poultry 
directly  from  their  establishments  of  origin,  provided  that  they  are  not  unloaded 
again following those operations before:  

(a) 

arriving at their establishment or final place of destination; or  

(b) 

an assembly operation provided for in paragraph 1(b) and (c). 

Article 131 
Disease prevention requirements for assembly operations 

Operators conducting assembly operations shall ensure that: 

(a) 

(b) 

the kept ungulates and poultry assembled are of the same health status or where they 
are  not  of  the  same  health  status,  the  lower  health  status  shall  apply  to  all  such 
animals assembled; 

the  kept  ungulates  and  poultry  are  assembled  and  moved  to  their  final  place  of 
destination  in  another  Member  State  as  soon  as  possible  after  leaving  their 
establishment  of  origin,  and  at  the  latest  within  a  timeframe  to  be  laid  down  in 
delegated acts adopted pursuant to Article 132(c);  

(c) 

the  necessary  biosecurity  measures  are  taken  to  ensure  that  the  kept  ungulates  and 
poultry assembled: 

(i) 

do  not  come  into  contact  with  kept  ungulates  or  poultry  of  a  lower  health 
status;  

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(ii)  do not pose a significant risk for the spread of the listed diseases referred to in 
Article  8(1)(d)  to  the  kept  ungulates  or  poultry  at  the  place  of  the  assembly 
operation;  

(d) 

the  kept  ungulates  or  poultry  are  identified  and,  where  required,  accompanied  with 
the following documents: 

(i) 

the  identification  and  registration  documents  where  provided  for  in  Articles 
106(b), 107(b), 109(c), 110(b) and Article113(b) and rules adopted pursuant to 
Articles 114 and 117, unless derogations are provided for according to Article 
115;  

(ii) 

the  animal  health  certificates  where  provided  for  in  Article  140  and  Article 
141(c),  unless  derogations  are  provided  for  in  the  rules  adopted  pursuant  to 
Article 141(a); 

(iii) 

the self-declaration document where provided for in Article 148. 

Article 132 
Delegation of powers concerning assembly operations 

The Commission shall be empowered to adopt delegated acts in accordance with Article 253 
concerning: 

(a) 

(b) 

(c) 

specific  rules  for  assembly  operations,  where  other  risk  mitigating  measures,  in 
addition to those provided for in Article 131(b) and (c), are in place;  

criteria under which Member States of origin may allow assembly operations to take 
place  on  means  of  transport,  as  provided  for  in  the  second  subparagraph  of  Article 
130(2);  

the  timeframe  between  the  time  of  departure  of  the  kept  ungulates  or  poultry  from 
their establishment of origin and their departure from the assembly operation to their 
final destination in another Member State as referred to in Article 131(b); 

(d) 

biosecurity measures provided for in Article 131(c).  

SECTION 5  
MOVEMENTS TO OTHER MEMBER STATES OF KEPT TERRESTRIAL ANIMALS 
OTHER THAN KEPT UNGULATES AND POULTRY 

Article 133 
Movement of kept terrestrial animals other than kept ungulates and poultry to other Member 
States and delegated acts 

1. 

Operators  shall  only  move  kept  terrestrial  animals  other  than  kept  ungulates  or 
poultry from an establishment in one Member State to another Member State if they 
do  not  pose  a  significant  risk  for  the  spread  of  listed  diseases  referred  to  in 
Article 8(1)(d) at the place of destination.  

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2. 

3. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning detailed rules to ensure that the kept terrestrial animals other 
than kept ungulates or poultry do not pose a significant risk for the spread of listed 
diseases referred to in Article 8(1)(d) provided for in paragraph 1 of this Article. 

The Commission shall take the following matters into account, when establishing the 
detailed rules to be laid down in the delegated acts provided for in paragraph 2:  

(a) 

(b) 

the listed diseases referred to in Article 8(1)(d) relevant for the listed species or 
the category of kept terrestrial animals to be moved;  

the health status as regards the listed diseases referred to in Article 8(1)(d) at 
the establishments, compartments, zones and Member States of origin and the 
place of destination;  

(c) 

the types of establishment and the types of production at the place of origin and 
the place of destination; 

(d) 

the types of movement in respect of the final use of animals at destination;  

(e) 

the categories and species of kept terrestrial animals to be moved;  

(f) 

the age of the kept terrestrial animals to be moved; 

(g)  other epidemiological factors. 

SECTION 6 
DEROGATING FROM AND SUPPLEMENTING RISK MITIGATION MEASURES  

Article 134 
Animals intended for confined establishments and delegated acts 

1. 

Operators shall only move kept terrestrial animals to a confined establishment if they 
comply with the following conditions:  

(a) 

they originate from another confined establishment;  

(b) 

they do not pose a significant risk for the spread of listed diseases referred to in 
Article  8(1)(d)  to  listed  species  or  to  categories  of  animals  at  the  confined 
establishment  of  destination,  except  where  such  movement  is  authorised  for 
scientific purposes. 

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning: 

(a) 

(b) 

detailed  rules  for  movements  of  kept  terrestrial  animals  into  confined 
establishments in addition to those provided for in paragraph 1 of this Article;  

specific  rules  for  movements  of  kept  terrestrial  animals  into  confined 
establishments where the risk mitigating measures in place guarantee that such 

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movements  do  not  pose  a  significant  risk  for  the  health  of  kept  terrestrial 
animals within that confined establishment and the surrounding establishments. 

Article 135 
Derogations for movements of kept terrestrial animals for scientific purposes and delegated 
acts 

1. 

2. 

The competent authority of the place of destination may, subject to the agreement of 
the competent authority of the place of origin, authorise movements into the territory 
of the Member State of kept terrestrial animals for scientific purposes, which do not 
comply with the requirements of Sections 1 to 5, with the exception of Articles 121 
and 122, Article 123(1)(a)(ii) and Article 124. 

The  competent  authorities  shall  only  grant  derogations  provided  for  in  paragraph  1 
under the following conditions: 

(a) 

the competent authorities of the place of destination and origin: 

(i) 

have agreed on the conditions for such movements; 

(ii)  have  taken  the  necessary  risk  mitigating  measures  to  ensure  that  those 
movements do not jeopardise the health status en route and the places of 
destination with regard to the listed diseases referred to in Article 8(1)(d);  

(iii)  have notified, where relevant, the competent authority of Member States 
of passage of the derogation granted and the conditions under which it is 
granted;  

(b) 

those  movements  of  those  animals  take  place  under  the  supervision  of  the 
competent authorities of places of  origin and  destination, and  where relevant, 
the competent authority of the Member State of passage.  

3. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning amending and supplementing the rules for derogations by the 
competent authorities provided for in paragraphs 1 and 2 of this Article.  

Article 136 
Derogations concerning recreational use, sporting and cultural events, grazing and work 
near borders  

1. 

The competent authority of the place of destination may grant derogations from the 
requirements  of  Sections  2  to  5,  with  the  exception  of  Article  123(a)  and  (b)  and 
Articles 124 and 125, for intra-Union movements of kept terrestrial animals between 
Member States where such movements are for: 

(a) 

recreational use near borders;  

(b) 

exhibitions,  and  for  sporting,  cultural  and  similar  events  organised  near 
borders; 

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(c) 

grazing  of  kept  terrestrial  animals  in  grazing  areas  shared  between  Member 
States; 

(d)  work of kept terrestrial animals near borders of Member States. 

2. 

3. 

4. 

Derogations by the competent authority of the place of destination for movements of 
kept terrestrial animals for the purposes provided for in paragraph 1 shall be agreed 
on  between  the  Member  States  of  origin  and  destination  and  appropriate  risk 
mitigating measures taken to ensure that such movements do not pose a significant 
risk. 

The  Member  States  referred  to  in  paragraph  2  shall  inform  the  Commission  of  the 
granting of derogations provided for in paragraph 1.  

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning amending and supplementing the rules for derogations by the 
competent  authority  of  the  place  of  destination  provided  for  in  paragraph  1  of  this 
Article. 

Article 137 
Delegation of power concerning derogations for circuses, exhibitions, sporting events and 
recreational use, zoos, pet shops, and wholesalers  

The Commission shall be empowered to adopt delegated acts in accordance with Article 253 
concerning:  

(a) 

specific  requirements  supplementing  the  rules  laid  down  in  Sections  2  to  5  for  the 
movements of kept terrestrial animals for the following purposes:  

(i) 

circuses, zoos, pet shops, animal shelters and wholesalers;  

(ii) 

exhibitions and for sporting, cultural and similar events; 

(b) 

derogations  from  Sections  2  to  5  with  the  exception  of  Article  123(a)  and  (b)  and 
Articles  124  and  125  for  the  movements  of  kept  terrestrial  animals  referred  to  in 
point (a).  

Article 138 
Implementing power for temporary derogations for movements of specific species or 
categories of kept terrestrial animals 

The Commission may, by means of implementing acts lay down rules concerning temporary 
derogations  from  the  rules  laid  down  in  this  Chapter  for  movements  of  specific  species  or 
categories of kept terrestrial animals where: 

(a) 

the movement requirements provided for in Article 127, Article 129(1), Articles 130 
and131,  Articles  133(1),  134(1)  and  135(1)  and  (2)  and  Article  136  and  the  rules 
adopted pursuant to Articles 128(1) and 129(2), Article 132, Articles 133(2), 134(2), 
135(3) and 136(4) and Article 137 are not effectively mitigating the risks posed by 
the movement of such animals; or 

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(b) 

the  listed  disease  referred  to  in  Article  8(1)(d)  appears  to  be  spreading  despite  the 
movement requirements laid down in accordance with Sections 1 to 6. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 255(2).  

On  duly  justified  imperative  grounds  of  urgency  relating  to  diseases  representing  a  risk  of 
highly  significant  impact  and  taking  into  account  the  matters  referred  to  in  Article  139  the 
Commission  shall  adopt  immediately  applicable  implementing  acts  in  accordance  with  the 
procedure provided for in Article 255(3). 

Article 139 
Matters to be taken into account when adopting delegated and implementing acts provided for 
in this Section 

The Commission shall take the following matters into account, when establishing the rules to 
be laid down in the delegated and implementing acts provided for in Articles 134(2), 135(3) 
and 136(4) and Articles 137 and 138: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

the risks involved with the movements referred to in those provisions;  

the  health  status  as  regards  the  listed  diseases  referred  to  in  Article  8(1)(d)  at  the 
places of origin and destination; 

listed animal species for the listed diseases referred to in Article 8(1)(d); 

biosecurity measures in place at the places of origin, destination and en route; 

any specific conditions in establishments under which the kept terrestrial animals are 
kept; 

specific movement patterns of the type of establishment and the species and category 
of kept terrestrial animals concerned; 

(g) 

other epidemiological factors. 

SECTION 7 
ANIMAL HEALTH CERTIFICATION 

Article 140 
Obligation of operators to ensure that animals are accompanied by an animal health 
certificate  

1. 

Operators  shall  only  move  the  following  species  and  categories  of  kept  terrestrial 
animals  to  another  Member  State  if  they  are  accompanied  by  an  animal  health 
certificate  issued  by  the  competent  authority  of  the  Member  State  of  origin  in 
accordance with Article 146(1): 

(a) 

ungulates; 

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(b)  poultry; 

(c) 

kept  terrestrial  animals  other  than  ungulates  and  poultry,  intended  for  a 
confined establishment; 

(d)  kept terrestrial animals other than those referred to in points (a), (b) and (c) of 
this  paragraph,  when  required  in  accordance  with  delegated  acts  adopted 
pursuant to Article 141(1)(c). 

2. 

Operators shall not move kept terrestrial animals within a Member State or from one 
Member  State  to  another  Member  State  unless  they  are  accompanied  by  an  animal 
health certificate issued by the competent authority of the Member State of origin in 
accordance  with  Article  146(1),  where  the  conditions  referred  to  in  the  following 
points (a) and (b) are meet:  

(a) 

the kept terrestrial animals are allowed to leave a restricted zone provided for 
in  Article  55(1)(f)(ii),  Article  56  and  Article  64(1)  and  are  subject  to  disease 
control  measures  provided  for  in  Articles  55(1),  65(1),  74(1)  or  Article  78(1) 
and  (2)  or  rules  adopted  pursuant  to  Article  55(2),  Article  67,  Articles  71(3) 
and 74(3), Article 79, Article 81(3) or Article 248;  

(b) 

the  kept  terrestrial  animals  are  of  species  subject  to  those  disease  control 
measures. 

3. 

Operators  shall  take  all  necessary  measures  to  ensure  that  the  animal  health 
certificate referred to in paragraph 1 of this Article accompanies the kept terrestrial 
animals from their place of origin to their final place of destination, unless specific 
measures are provided for in rules adopted pursuant to Article 144. 

Article 141 
Delegation of powers concerning the obligation of operators to ensure that animals are 
accompanied by an animal health certificate 

1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning:  

(a) 

derogations  from  the  animal  health  certification  requirements  provided  for  in 
Article 140(1), for movements of kept terrestrial animals, which do not pose a 
significant risk for the spread of a disease due to: 

(i) 

the  species  or  categories  of  the  kept  terrestrial  animals  that  are  being 
moved and the listed diseases referred to in Article 8(1)(d) for which they 
are listed species;  

(ii) 

the methods of keeping and the type of production of those species and 
categories of kept terrestrial animals; 

(iii) 

the intended use of the kept terrestrial animals;  

(iv) 

the place of destination of the kept terrestrial animals; or 

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(b) 

special rules for animal health certification requirements provided for in Article 
140(1)  where  specific  risk  mitigating  measures  concerning  surveillance  or 
biosecurity  are  taken  by  the  competent  authority,  taking  into  account  the 
matters provided for in paragraph 2 of this Article, which ensure: 

(i) 

the traceability of the kept terrestrial animals being moved;  

(ii) 

that  the  kept  terrestrial  animals  being  moved  comply  with  required 
animal health requirements for movements provided for in Sections 1 to 
6;  

(c) 

the  requirement  for  animal  health  certification  for  movements  of  species  and 
categories  of  kept  terrestrial  animals  other  than  those  referred  to  in 
Article 140(1)(a)(b)  and  (c)  in  cases  where  animal  health  certification  is 
imperative to ensure that the movement in question complies with the animal 
health requirements for movements provided for in Sections 1 to 6.  

2. 

When establishing the special rules provided for in paragraph 1(b), the Commission 
shall take the following matters into account: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

the confidence of the competent authority about the biosecurity put in place by 
operators  as  provided  for  in  Article  9(1)(b)  and  rules  adopted  pursuant 
Article 9(2); 

the  capability  of  the  competent  authority  to  take  necessary  and  appropriate 
measures and activities required by this Regulation as  provided  for in Article 
12(1); 

the  level  of  obtained  basic  knowledge  of  animal  health  as  provided  for  in 
Article 10 and the support provided for in Article 12(2); 

the  performance  of  the  animal  health  visits  as  provided  for  in  Article  23  and 
rules adopted pursuant to Article 24, where other relevant surveillance, quality 
assurance schemes or official controls as referred to in Article 23(1)(c) are not 
in place; 

the  performance  of  the  Union  notification  and  reporting  as  provided  for  in 
Articles 17 to 20 and the rules adopted pursuant to Articles 17(3) and18(3) and 
Article 21 applied by the competent authority;  

the  application  of  surveillance  as  provided  for  in  Article  25  and  surveillance 
programmes  as  provided  for  in  Article  27  and  rules  adopted  pursuant  to 
Articles 28 and 29.  

3. 

The  Commission  shall  take  the  matters  referred  to  in  paragraph  1(a)(i)  to  (iv)  into 
account, when establishing the requirements for animal health certification provided 
for in paragraph (1)(c) of this Article. 

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Article 142 
Contents of animal health certificates  

1. 

The animal health certificate shall contain the following information:  

(a) 

the  establishment  or  place  of  origin,  the  establishment  or  place  of  destination 
and, where relevant, establishments for assembly operations or for rests of the 
kept terrestrial animals; 

(b) 

a description of kept terrestrial animals;  

(c) 

the number of kept terrestrial animals; 

(d) 

the identification and registration of kept terrestrial animals, where required by 
Articles 106, 107, 109, 110 and 113 and rules adopted pursuant to Articles 114 
and  117,  unless  derogations  are  provided  for  in  accordance  with  Article  115; 
and 

(e) 

the  necessary  information  needed  to  demonstrate  that  the  kept  terrestrial 
animals  comply  with  the  relevant  animal  health  requirements  for  movements 
provided for in Sections 1 to 6. 

2. 

The  animal  health  certificate  may  include  other  information  required  under  other 
Union legislation. 

Article 143 
Delegation of powers and implementing acts concerning the contents of animal health 
certificates  

1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning: 

(a) 

detailed  rules  on  the  content  of  animal  health  certificates  provided  for  in 
Article  142(1)  for  different  categories  and  species  of  kept  terrestrial  animals 
and for specific types of movements provided for in the rules adopted pursuant 
to Article 144;  

(b) 

additional information to be contained in the animal health certificate provided 
for in Article 142(1).  

2. 

The  Commission  may,  by  means  of  implementing  acts,  lay  down  rules  for  model 
forms  of  animal  health  certificates.  Those  implementing  acts  shall  be  adopted  in 
accordance with the examination procedure referred to in Article 255(2).  

Article 144 
Delegation of powers concerning specific types of movements of kept terrestrial animals  

The Commission shall be empowered to adopt delegated acts in accordance with Article 253 
concerning specific measures supplementing the obligation of operators to ensure that animals 
are  accompanied  by  an  animal  health  certificate  provided  for  in  Article  140  and  the  rules 

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adopted  pursuant  to  Article  141  for  the  following  types  of  movements  of  kept  terrestrial 
animals: 

(a) 

(b) 

movements  of  kept  ungulates  and  poultry  passing  through  the  assembly  operations 
provided for in Article 130 prior to reaching their final place of destination; 

movements  of  kept  terrestrial  animals,  which  may  not  continue  their  route  to  their 
final place of destination and are required to return to their place of origin or to be 
moved to a different destination, for one or more of the following reasons: 

(i) 

their intended route was unexpectedly interrupted for animal welfare reasons;  

(ii)  unpredicted accidents or events en route;  

(iii) 

the  kept  terrestrial  animals  were  rejected  at  the  place  of  destination  in  a 
Member State or at the external border of the Union; 

(iv) 

the kept terrestrial animals were rejected at a place of assembly or resting;  

(v) 

the kept terrestrial animals were rejected in a third country;  

(c) 

movements of kept terrestrial animals intended for exhibitions and sporting, cultural 
and similar events, and their subsequent return to their place of origin.  

Article 145 
Operators obligations to cooperate with the competent authority for animal health 
certification  

Operators shall:  

(a) 

(b) 

1. 

provide  the  competent  authority  with  all  the  information  necessary  to  complete  the 
animal  health  certificate  provided  for  in  Article  140(1)  and  (2)  and  rules  adopted 
pursuant to Article 143(1) or Article 144;  

where  necessary,  subject  the  kept  terrestrial  animals  to  documentary,  identity  and 
physical checks as provided for in Article 146(3). 

Article 146 
Competent authority responsibility for animal health certification  

The  competent  authority  shall,  upon  request  by  the  operator  issue  an  animal  health 
certificate  for  the  movement  of  kept  terrestrial  animals  to  another  Member  State, 
where  required  by  Article  140  or  by  delegated  acts  adopted  pursuant  to 
Articles 141(1) and 143(2) provided that the following movement requirements have 
been complied with:  

(a) 

those provided for in Article 121, Article 122(1), Articles 123, 125, 126, 127, 
129, 130 and131, Articles 133(1) and 134(1), Article 135 and Article 136; 

EN 

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(b) 

those  provided  for  in  delegated  acts  adopted  pursuant  to  Articles  122(2)  and 
128(1), Article 132, and Articles 133(2), 134(2), 135(4) and 136(4) and Article 
137; 

(c) 

those provided for in implementing acts adopted pursuant to Article 138.  

2. 

Animal health certificates shall: 

(a) 

be verified and signed by the official veterinarian; 

(b) 

remain valid for the period of time, provided for in the rules adopted pursuant 
to  paragraph  4(c),  during  which  the  kept  terrestrial  animals  covered  by  it, 
continue to comply with the animal health guarantees contained in it.  

3. 

4. 

The official veterinarian shall, before signing an animal health certificate, verify that 
the  kept  terrestrial  animals  covered  by  it  comply  with  the  requirements  of  this 
Chapter by means of documentary, identity and physical checks as provided for by 
delegated acts adopted pursuant to paragraph 4. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 laying down rules for:  

(a) 

the types of documentary, identity and physical checks for different species and 
categories  of  kept  terrestrial  animals  that  must  be  carried  out  by  the  official 
veterinarian  in  accordance  with  paragraph  3  of  this  Article  to  verify 
compliance with the requirements of this Chapter; 

(b) 

the timeframes for the carrying out of such documentary, identity and physical 
checks and the issuing of animal health certificates by the official veterinarian 
prior to the movement of consignments of kept terrestrial animals; 

(c) 

the duration of the validity of animal health certificates. 

Article 147 
Electronic animal health certificates 

Electronic animal health certificates, produced, handled and transmitted by means of IMSOC, 
may replace accompanying animal health certificates provided for in Article 146(1) where:  

(a) 

(b) 

such electronic animal health certificates contain all the information that the model 
form of animal health certificate is required to contain in accordance with Article 142 
and rules adopted pursuant to Article 143;  

the traceability of the kept terrestrial animals and the link between those animals and 
the electronic animal health certificate is ensured. 

Article 148 
Self-declaration by operators for movements to other Member States 

1. 

Operators  at  the  place  of  origin,  shall  issue  a  self-declaration  document  for 
movements of kept terrestrial animals from their place of origin in one Member State 

EN 

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to their place of destination in another Member State and ensure that it accompanies 
such  animals,  where  they  are  not  required  to  be  accompanied  by  an  animal  health 
certificate provided for in Article 140(1) and (2).  

2. 

The  self-declaration  document  provided  for  in  paragraph  1  shall  contain  the 
following information concerning the kept terrestrial animals: 

(a) 

(b) 

(c) 

their place of origin, their place of destination and when relevant any places of 
assembly or rest;  

a  description  of  the  kept  terrestrial  animals,  their  species,  category  and 
quantity; 

identification and registration where required in accordance with Articles 106, 
107,  109  and  110,  and  Article  113(a)  and  rules  adopted  pursuant  to  Articles 
114 and 117; 

(d) 

information needed to demonstrate that the kept terrestrial animals comply with 
the animal health requirements for movements provided for in Sections 1 to 6. 

3. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning: 

(a) 

(b) 

detailed  rules  on  the  content  of  the  self-declaration  document  provided  for  in 
paragraph 2 of this Article for different categories and species of animals;  

information to be contained in the self-declaration document in addition to that 
provided for in paragraph 2 of this Article.  

4. 

The Commission may, by means of implementing acts, lay down rules for the model 
forms of the self-declaration documents provided for in paragraph 2 of this Article. 
Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2).  

SECTION 8 
NOTIFICATION OF MOVEMENTS OF KEPT TERRESTRIAL ANIMALS TO OTHER 
MEMBER STATES  

Article 149 
Obligation of operators concerning the notification of movements of kept terrestrial animals 
to other Member States 

Operators shall notify the competent authority in their Member State of origin in advance of 
intended  movements  of  kept  terrestrial  animals  from  that  Member  State  to  another  Member 
State where: 

(a) 

the  animals  must  be  accompanied  by  an  animal  health  certificate  issued  by  the 
competent authority of the Member State of origin in accordance with Articles 146 
and 147 and rules adopted pursuant to Article 146(4); 

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(b) 

(c) 

the animals must be accompanied by an animal health certificate for kept terrestrial 
animals where they are being moved from a restricted zone and are subject to disease 
control measures as referred to in Article 140(2); 

notification  is  required  in  accordance  with  delegated  acts  adopted  pursuant  to 
Article 151(1). 

For the purposes of the first paragraph of this Article, operators shall provide the competent 
authority  of  their  Member  State  of  origin  with  all  the  necessary  information  to  enable  it  to 
notify the movements of the kept terrestrial animals to the competent authority of the Member 
State of destination in accordance with Article 150(1). 

Article 150 
Competent authority responsibility for notification of movements to other Member States 

1. 

2. 

3. 

4. 

The  competent  authority  of  the  Member  State  of  origin  shall  notify  the  competent 
authority of the Member State of destination of movements of kept terrestrial animals 
as referred to in Article 149. 

The  notification  referred  to  in  paragraph  1  shall  be  carried  out,  whenever  possible, 
through IMSOC. 

Member  States  shall  designate  regions  for  the  management  of  notifications  of 
movements as provided for in paragraph 1. 

By  way  of  derogation  from  paragraph  1,  the  competent  authority  of  the  Member 
State  of  origin  may  authorise  the  operator  to  notify  partially  or  completely 
movements of kept terrestrial animals through IMSOC to the competent authority of 
the Member State of destination. 

Article 151 
Delegation of power and implementing acts for the notification of movements by operators 
and the competent authority 

1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning:  

(a) 

(b) 

(c) 

the  requirement  for  advance  notification  by  operators  of  movement  of  kept 
terrestrial  animals  between  Member  States  in  accordance  with  Article  149  of 
categories or species of  animals  other than  those  referred to in  points  (a)  and 
(b)  of  that  Article,  where  traceability  of  such  movements  of  those  species  or 
categories  is  necessary  to  ensure  compliance  with  the  animal  health 
requirements for movements laid down in Sections 1 to 6;  

the  information  necessary  to  notify  movements  of  kept  terrestrial  animals  as 
provided for in Articles 149 and 150; 

the emergency procedures for the notification of movements of kept terrestrial 
animals in the case of power cuts and other disturbances of IMSOC; 

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(d) 

the  requirements  for  the  designation  of  regions  by  Member  States  for  the 
management of notification of movements provided for in Article 150(3). 

2. 

The Commission may, by means of implementing acts lay down rules concerning:  

(a) 

the format of notifications of movements of kept terrestrial animals by:  

(i) 

operators  to  the  competent  authority  of  their  Member  State  of  origin  in 
accordance with Article 149; 

(ii) 

the  competent  authority  of  the  Member  State  of  origin  to  the  Member 
State of destination in accordance with Article 150; 

(b) 

the deadlines for:  

(i) 

(ii) 

the necessary information referred to in Article 149 to be provided by the 
operator to the competent authority of the Member State of origin;  

the  notification  of  movements  of  movements  of  kept  terrestrial  animals 
by the competent authority of the Member State of origin referred to in 
Article 150(1). 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2).  

Chapter 4 
Movements within the Union of terrestrial pet animals 

Article 152 
Non-commercial movements of terrestrial pet animals and delegated and implementing acts 

1. 

Pet keepers shall only carry out non-commercial movements of terrestrial pet animals 
of  the  species  listed  in  Annex  I  from  one  Member  State  to  another  Member  State 
where: 

(a) 

(b) 

those  terrestrial  pet  animals  are  identified  and  accompanied  with  an 
identification document when required in accordance with Article 112 or rules 
adopted pursuant to Article 114(e) and Article 117;  

appropriate  prevention  and  disease  control  measures  have  been  taken  during 
that  movement,  to  ensure  that  the  terrestrial  pet  animals  do  not  pose  a 
significant  risk  for  the  spread  of  listed  diseases  referred  to  in  Article 8(1)(d) 
and emerging diseases to kept terrestrial animals at the place of destination and 
during transport. 

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  the  prevention  and  disease  control  measures  referred  to  in 
paragraph 1(b) of this Article to ensure that the terrestrial pet animals do not pose a 
significant risk for the spread of diseases referred to in Article 8(1)(d) and emerging 

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diseases to animals during transport and at the place of destination and when relevant 
taking into account the health status of the place of destination. 

3. 

The Commission may, by means of implementing acts lay down rules concerning the 
prevention and disease control measures provided for in paragraph 1 of this Article 
and the rules adopted pursuant to paragraph 2 thereof. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 254(2).  

Chapter 5 
Movement of wild terrestrial animals 

Article 153 
Wild terrestrial animals 

1. 

Operators  shall  only  move  wild  animals  from  a  habitat  in  one  Member  State  to  a 
habitat or to an establishment in another Member State where:  

(a) 

(b) 

(c) 

(d) 

the movements of the wild animals from their habitat are carried out in such a 
way  that  they  do  not  pose  a  significant  risk  for  the  spread  of  listed  diseases 
referred  to  in  Article  8(1)(d)  or  emerging  diseases  en  route  or  at  the  place  of 
destination; 

the  wild  animals  do  not  come  from  a  habitat  in  a  restricted  zone  subject  to 
movement  restrictions  due  to  the  occurrence  of  a  listed  disease  referred  to  in 
Article  8(1)(d)  or  an  emerging  disease  for  the  listed  species  provided  for  in 
Article  70(2)(c),  Article  80(1)  and  (2)  and  rules  adopted  pursuant  to  Articles 
70(3)(b) and Articles71(3), 80(4) and Article 81(3) or the emergency measures 
provided for in Articles 245 and 246 and rules adopted pursuant to Article 248 
unless derogations have been granted in accordance to those rules;  

the  wild  animals  are  accompanied  by  an  animal  health  certificate  or  other 
documents where animal health certification is necessary to ensure compliance 
with the animal health requirements for movements provided for in points (a) 
and  (b)  of  this  paragraph  and  the  rules  adopted  pursuant  to  Article  154(1)(c) 
and (d) are complied with;  

the  movement  is  notified  by  the  competent  authority  of  the  Member  State  of 
origin  to  the  competent  authority  of  the  Member  State  of  destination,  when 
animal  health  certificate  is  required  by  the  rules  adopted  pursuant  to  Article 
154(1)(c) . 

2. 

3. 

When animal health certification is required by the rules adopted pursuant to Article 
154(1)(c) the requirements provided for  in Articles 142 and 145, Article 146(1),(2) 
and  (3),  Article  147  and  the  rules  adopted  pursuant  to  Articles  143  and  144  and 
Article 146(4), shall apply to movements of wild terrestrial animals. 

When  notification  of  movements  is  required  in  accordance  with  paragraph  1(d)  of 
this Article, the requirements provided for in Articles 149, 150 and the rules adopted 

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pursuant to delegated acts laid down in Article 151 shall apply to movements of wild 
terrestrial animals. 

Article 154 
Empowerments concerning the movement of wild terrestrial animals 

1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning: 

(a) 

(b) 

(c) 

(d) 

the  animal  health  requirements  for  movements  of  wild  terrestrial  animals 
provided for in Article 153(1)(a) and (b); 

the animal health requirements for the introduction of wild terrestrial animals 
when moved from the wild: 

(i) 

into establishments;  

(ii) 

for keeping as pet animals;  

the types of movements of wild terrestrial animals for which, or the situations 
in  which,  an  animal  health  certificate  or  other  document  is  required  to 
accompany  such  movements  and  the  requirements  concerning  the  contents  of 
such certificates or other documents;  

the notification by the competent authority of the Member State of origin to the 
competent  authority  of  the  Member  State  of  destination  in  the  case  of 
movements  of  wild  terrestrial  animals  between  Member  States  and  the 
information to be included in such notification. 

2. 

The Commission may, by means of implementing acts, lay down rules specifying the 
requirements provided for in Article 153 and the delegated rules adopted pursuant to 
paragraph 1 concerning:  

(a)  model  forms  of  animal  health  certificates  and  other  documents  which  are 
required  to  accompany  movements  of  the  wild  terrestrial  animals,  when 
provided for in delegated acts adopted pursuant to paragraph 1(c); 

(b) 

the format of the notification by the competent authority of the Member State 
of  origin  and  the  deadlines  for  such  notifications,  when  provided  for  in  rules 
adopted pursuant to paragraph 1(d). 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2).  

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Chapter 6 
Movements within the Union of germinal products  

SECTION 1 
GENERAL REQUIREMENTS 

Article 155 
General requirements for movement of germinal products  

1. 

Operators shall take appropriate preventive measures to ensure that the movement of 
germinal products does not jeopardise the health status of kept terrestrial animals at 
the place of destination with regard to: 

(a) 

the listed diseases referred to in Article 8(1)(d); 

(b) 

emerging diseases. 

2. 

Operators shall only move germinal products from their establishments, and receive 
such germinal products if they comply with the following conditions:  

(a) 

they come from establishments that have been: 

(i) 

entered  in  the  register  of  establishments  by  the  competent  authority  in 
accordance with Article 88(a) and no derogation has been granted by the 
Member State of origin in accordance with Article 83; 

(ii) 

approved  by  the  competent  authority  in  accordance  with  Article  92(1), 
when required by Article 89(1) or Article 90; 

(b) 

they  comply  with  the  traceability  requirements  of  Article  118(1)  and  rules 
adopted pursuant to Article 119(1). 

3. 

4. 

Operators  shall  comply  with  the  requirements  of  Article  122  for  the  transport  of 
germinal products of kept terrestrial animals. 

Operators  shall  not  move  germinal  products  from  an  establishment  in  one  Member 
State to an establishment in another Member State, unless the competent authority of 
the Member State of destination gives its express authorisation for such movement, 
where  those  germinal  products  are  required  to  be  destroyed  for  disease  eradication 
purposes as a part of an eradication programme provided for in Article 30(1) or (2). 

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Article 156  
Obligations for operators at the place of destination 

1. 

Operators  of  establishments  at  the  place  of  destination  receiving  germinal  products 
from an establishment in another Member State shall:  

(a) 

check for the presence of: 

(i) 

identification  marks  in  accordance  with  Article  118  and  rules  adopted 
pursuant to Article 119;  

(ii) 

animal health certificates as provided for in Article 159;  

(b) 

inform the competent authority of any irregularity with regard to:  

(i) 

the germinal products received; 

(ii) 

the presence of the means of identification referred to in point (a)(i); 

(iii) 

the presence of animal health certificates referred to in point (a)(ii). 

2. 

In the event of an irregularity as referred to in paragraph 1(b), the operator shall keep 
the germinal products under its supervision until the competent authority has taken a 
decision regarding them. 

SECTION 2 
MOVEMENTS TO OTHER MEMBER STATES OF GERMINAL PRODUCTS OF KEPT 
ANIMALS OF THE BOVINE, OVINE, CAPRINE, PORCINE AND EQUINE SPECIES AND 
OF POULTRY  

Article 157 
Operators obligations for movements of germinal products of kept animals of the bovine, 
ovine, caprine, porcine and equine species and of poultry to other Member States 

1. 

Operators  shall  only  move  germinal  products  of  kept  animals  of  the  bovine,  ovine, 
caprine, porcine and equine species and of poultry to another Member State if those 
germinal products comply with the following conditions:  

(a) 

(b) 

(c) 

they  are  collected,  produced,  processed  and  stored  in  germinal  product 
establishments approved for that purpose in accordance with Article 92(1) and 
Article 94;  

they  fulfil  the  traceability  requirements  for  the  type  of  germinal  product  in 
accordance with Article 118 and rules adopted pursuant to Article 119; 

they  have  been  collected  from  the  donor  animals  which  comply  with  the 
necessary animal health requirements to ensure that the germinal products do 
not spread listed diseases;  

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(d) 

they  have  been  collected,  produced,  processed,  stored  and  transported  in  a 
manner to ensure that they do not spread listed diseases.  

2. 

Operators  shall  not  move  germinal  products  of  kept  animals  of  the  bovine,  ovine, 
caprine,  porcine  and  equine  species  and  of  poultry  from  a  germinal  product 
establishment which is subject to movement restrictions affecting the listed species in 
accordance with:  

(a)  Article  55(1)(a),  (c),  (e)  and  Article  55(1)(f)(ii),  Article  56  and  Article 
61(1)(a), Article 62(1), Article 65(1)(c) and Articles 74(1), 78(1) and (2); 

(b) 

(c) 

rules  adopted  pursuant  to  Article  55(2),  Articles  63  and  67,  Articles  71(3) 
and74(3), Article 79 and Article 81(2); and  

emergency  measures  provided  for  in  Articles  246  and  247  and  rules  adopted 
pursuant  to  Article  248  unless  derogations  have  been  provided  for  in  rules 
adopted pursuant to Article 247.  

Article 158 
Delegation of power for movements of germinal products of kept animals of the bovine, 
porcine, ovine, caprine and equine species and of poultry to other Member States 

The Commission shall be empowered to adopt delegated acts in accordance with Article 253 
concerning  the  animal  health  requirements  for  movements  of  germinal  products  of  kept 
animals  of  the  bovine,  ovine,  caprine,  porcine  and  equine  species  and  of  poultry  to  other 
Member States provided for in Article 157, specifying: 

(a) 

rules  for  the  collection,  production,  processing  and  storage  of  germinal  products  of 
those kept animals in approved establishments as referred to in Article 157(1)(a);  

(b) 

animal health requirements provided for in Article 157(1)(c):  

(i) 

for kept animals from which germinal products were collected;  

(ii) 

isolation or quarantine for the kept donor animals referred to in (i); 

laboratory and other tests on kept donor animals and germinal products;  

animal  health  requirements  for  the  collection,  production,  processing,  storage  or 
other procedures and transport provided for in Article 157(1)(d); 

derogations  for  operators  from  the  rules  provided  for  in  Article  157,  taking  into 
account  the  risks  of  such  germinal  products  and  any  risk  mitigating  measures  in 
place. 

(c) 

(d) 

(e) 

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SECTION 3 
ANIMAL HEALTH CERTIFICATION AND NOTIFICATION OF MOVEMENTS 

Article 159 
Operators' obligations concerning animal health certification for movements of germinal 
products of kept animals of the bovine, ovine, caprine, porcine and equine species and of 
poultry and delegated acts  

1. 

Operators  shall  only  move  germinal  products  of  kept  animals  of  the  bovine,  ovine, 
caprine, porcine and equine species and of poultry where they are accompanied by an 
animal  health  certificate  issued  by  the  competent  authority  of  the  Member  State  of 
origin in accordance with paragraph 3 when they are moved: 

(a) 

to another Member State; 

(b)  within a Member State or to another Member State, where: 

(i) 

the  germinal  products  of  kept  animals  are  allowed  to  leave  a  restricted 
zone  subject  to  disease  control  measures  provided  for  in  Article 
55(1)(f)(ii)  and  Articles  56,  64  and  65,  Article  74(1)  and  Artilce78  and 
rules  adopted  pursuant  to  Article  55(2),  Article  67,  Articles  71(3) 
and74(3),  Article  79  and  Article  81(2)  or  the  emergency  measures 
provided  for  in  Articles  246  and  247  and  the  rules  adopted  pursuant  to 
Article 248 unless derogations have been granted from the animal health 
certification  requirement  in  accordance  with  the  rules  referred  in  this 
point; and 

(ii) 

the  germinal  products  of  kept  animals  are  of  species  subject  to  those 
disease control or emergency measures referred in point (i). 

2. 

3. 

4. 

5. 

Operators  shall  take  all  necessary  measures  to  ensure  that  the  animal  health 
certificate  referred  to  in  paragraph  1  accompanies  the  germinal  products  from  their 
place of origin to their place of destination. 

The  competent  authority  shall  upon  request  by  the  operator  issue  an  animal  health 
certificate for the movements of germinal products referred to in paragraph 1. 

Articles  142,  145,  146  and  147  and  the  rules  adopted  pursuant  to  Articles  143  and 
144 and Article 146(4), shall apply to the animal health certification of the germinal 
products referred to in paragraph 1 of this Article, and Article 148(1) and the rules 
adopted  pursuant  to  Article  148(2)  shall  apply  to  the  for  self-declaration  of 
movements of germinal products.  

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  derogations  from  the  animal  health  certificate  requirements 
provided for in paragraph 1 of this Article for the movements of germinal products of 
kept animals of the bovine, ovine, caprine, porcine and equine species and of poultry, 
which  do  not  pose  a  significant  risk  for  the  spread  of  listed  diseases  due  to  the 
following: 

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(a) 

(b) 

the nature of the germinal products or the species of animal that those products 
come from;  

the  methods  of  production  and  processing  at 
establishment; 

the  germinal  product 

(c) 

the intended use of the germinal products;  

(d) 

alternative  risk  mitigating  measures  in  place  for  the  type  and  category  of 
germinal products and the germinal product establishment. 

Article 160 
Content of animal health certificates  

1. 

The  animal  health  certificate  for  the  germinal  products  provided  for  in  Article  159 
shall contain at least the following information:  

(a) 

the germinal product establishment of origin and the establishment or place of 
destination; 

(b) 

the type of the germinal products and the species of kept donor animals;  

(c) 

the volume of the germinal products; 

(d) 

(e) 

the marking of the germinal products, when required by Articles 118(1) and by 
rules adopted pursuant to Article 119(1);  

information  needed  to  demonstrate  that  the  germinal  products  of  the 
consignment comply with the movement requirements for the relevant species 
provided for in Articles 155 and 157 and rules adopted pursuant to Article 158. 

The  animal  health  certificate  for  the  germinal  products  provided  for  in  Article  159 
may include other information required under other Union legislation.  

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning: 

(a) 

(b) 

the  information  to  be  contained  in  the  animal  health  certificate  pursuant  to 
paragraph 1 of this Article; 

animal  health  certification  for  different  types  of  germinal  products  and  of 
different animal species.  

The  Commission  may,  by  means  of  implementing  acts,  lay  down  rules  concerning 
model forms of animal health certificates for germinal products. Those implementing 
acts  shall  be  adopted  in  accordance  with  the  examination  procedure  referred  to  in 
Article 255(2).  

2. 

3. 

4. 

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Article 161 
Notification of movements of germinal products of kept animals of the bovine, ovine, caprine, 
porcine and equine species and of poultry to other Member States 

1. 

Operators shall:  

(a) 

inform the competent authority in their Member State of origin in advance of 
the  intended  movement  of  germinal  products  of  kept  animals  of  the  bovine, 
ovine,  caprine,  porcine  and  equine  species  and  of  poultry  to  another  Member 
State when:  

(i) 

the  germinal  products  are  required  to  be  accompanied  by  an  animal 
health certificate in accordance with Article 159(1); 

(ii)  notification  of  movement  is  required  in  accordance  with  delegated  acts 
adopted  pursuant  to  Article  151(1)  for  germinal  products,  taking  into 
account paragraph 3 of this Article; 

(b)  provide all the necessary information to enable the competent authority of the 
Member State of origin to notify the movement of the germinal products to the 
competent  authority  of  the  Member  State  of  destination  in  accordance  with 
paragraph 2. 

The  competent  authority  of  the  Member  State  of  origin  shall  notify  the  competent 
authority of the Member State of destination of movements of germinal products of 
kept animals of the bovine, ovine, caprine, porcine and equine species and of poultry 
in accordance with the rules adopted pursuant to Article 151. 

Articles 149 and 150 and rules adopted pursuant to Article 151 shall be applicable to 
the notification of germinal products. 

2. 

3. 

SECTION 4 
MOVEMENTS TO OTHER MEMBER STATES OF GERMINAL PRODUCTS OF KEPT 
TERRESTRIAL ANIMALS OF SPECIES OTHER THAN BOVINE, OVINE, CAPRINE, 
PORCINE AND EQUINE SPECIES AND OF POULTRY 

Article 162 
Germinal products of kept terrestrial animals other than those of the bovine, ovine, caprine, 
porcine and equine species and of poultry 

1. 

2. 

Operators  shall  only  move  germinal  products  of  kept  terrestrial  animals  of  species 
other  than  those  of  the  bovine,  ovine,  caprine,  porcine  and  equine  species  and  of 
poultry to another Member State if they do not pose a significant risk for the spread 
of  listed  diseases  referred  to  in  Article 8(1)(d)  to  listed  species  at  the  place  of 
destination, taking into account the health status at the place of destination.  

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  animal  health  requirements,  animal  health  certification  and 
notification  requirements  for  movements  of  germinal  products  of  kept  terrestrial 

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animals of species other than those of the bovine, ovine, caprine, porcine and equine 
species and of poultry taking into account the following matters: 

(a) 

listed diseases referred to in Article 8(1)(d) for the listed species;  

(b) 

the  species  of  animals  from  which  the  germinal  product  have  been  collected 
and type of germinal product;  

(c) 

the health status at the places of origin and of destination; 

(d) 

the type of collection, production, processing and storage; 

(e) 

other epidemiological factors. 

3. 

Where animal health certification and the notification of movements of the germinal 
products are required in accordance with paragraph 2 of this Article:  

(a) 

the  rules  provided  for  in  Articles  159,  160  and  Article  161  and  the  rules 
adopted  pursuant  to  Articles  159(5)  and  160(3)  shall  apply  for  such 
certification;  

(b) 

the  rules  provided  for  in  Article  161(1)  and  (2)  shall  apply  for  movement 
notification. 

SECTION 5 
DEROGATIONS 

Article 163 
Germinal products intended for scientific purposes and delegated acts 

1. 

By way of derogation from Sections 1 to 4, the competent authority of the place of 
destination  may  authorise  movements  of  germinal  products  for  scientific  purposes, 
which do not comply with the requirements of those Sections, with the exception of 
Article  155(1),  Article  155(2)(c),  Article  155(3)  and  Article156,  subject  to 
compliance with the following conditions: 

(a) 

prior  to  granting  such  authorisation  the  competent  authority  of  the  place  of 
destination must take the necessary risk mitigating measures to ensure that the 
movements  of  those  germinal  products  do  not  jeopardise  the  health  status  en 
route and of the places of destination with regard to the listed diseases referred 
to in Article 8(1)(d); 

(b) 

the movements of those germinal products take place under the supervision of 
the competent authority of the place of destination. 

2. 

When granting a derogation in accordance with paragraph 1, the competent authority 
of the place of destination shall notify the Member States of origin and the Member 
States  of  passage  of  the  derogation  granted  and  the  conditions  under  which  it  has 
been granted.  

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3. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning conditions for derogations by the competent authority of the 
place of destination, as provided for in paragraph 1 of this Article.  

Chapter 7 
Production, processing and distribution within the Union of 
products of animal origin  

1. 

2. 

Article 164 
General animal health obligations for operators and delegated acts 

Operators  shall  take  appropriate  preventive  measures  to  ensure  that  at  all  stages  of 
the production, processing and distribution of products of animal origin in the Union, 
such products do not cause the spread of: 

(a) 

listed diseases referred to in Article 8(1)(d) taking into account the health status 
of the place of production, processing or destination; 

(b) 

emerging diseases. 

Operators  shall  ensure  that  products  of  animal  origin  do  not  come  from 
establishments or food business establishments or are obtained from animals which 
come from establishments subject to: 

(a) 

emergency  measures  provided  for  in  Articles  246  and  247  and  rules  adopted 
pursuant to Article 248 unless derogations from the requirement provided for 
in paragraph 1 are provided for in rules adopted pursuant to Article 248; 

(b)  movement  restrictions  applicable  to  kept  terrestrial  animals  and  products  of 
animal  origin,  as  provided  for  in  Articles  31(1),  Article  55(1)(e),  Article  56, 
Article  61(1)(a),  Article 62(1),  Article  65(1)(c),  Article  70(1)(b),  Article 
74(1)(a), Article 78(1) and (2) and the rules adopted pursuant to Articles 55(2), 
Articles  63  and  66,  Article  71(3),  Article  74(3)  and  Articles  79  and  Article 
81(2) unless derogations from those movement restrictions are provided for in 
those rules. 

3. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  detailed  requirements  amending  and  supplementing  the 
requirements of paragraph 2 of this Article for the movement of products of animal 
origin, taking into account:  

(a) 

the listed disease referred to in Article 8(1)(d) and species concerned by it and  

(b) 

the risks involved. 

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Article 165 
Animal health certificates obligations on operators and delegated acts 

1. 

Operators shall only move the following products of animal origin within a Member 
State or to another Member State where they are accompanied by an animal health 
certificate  issued  by  the  competent  authority  of  the  Member  State  of  origin  in 
accordance with paragraph 3:  

(a) 

products of animal origin that:  

(i) 

are  allowed  to  be  moved  from  a  restricted  zone  subject  to  emergency 
measures provided for in rules adopted pursuant to Article 248;  

(ii)  originate from animals of species subject to those emergency measures;  

(b)  products of animal origin that: 

(i) 

are allowed to be moved from restricted zone subject to disease control 
measures  in  accordance  with  Article  31(1),  Article  55(1)(f)(ii),  Article 
56, Article 61(1)(a), Article 62(1), Article 64, Articles 65(1)(c), 70(1)(b) 
and  74(1)(a)  and  Article78(1)  and  (2)  and  rules  adopted  pursuant  to 
Articles 55(2), Articles 63 and 67, Article 71(3) and74(3), Article 79 and 
Article 81(2),  

(ii)  originate  from  animals  of  species  subject  to  those  disease  control 

measures. 

2. 

3. 

4. 

5. 

Operators  shall  take  all  necessary  measures  to  ensure  that  the  animal  health 
certificate referred to in paragraph 1 accompanies the products of animal origin from 
their place of origin to their place of destination. 

The  competent  authority  shall  upon  request  by  the  operator  issue  an  animal  health 
certificate for the movements of products of animal origin referred to in paragraph 1. 

Articles 145, 146 and 147 and the rules adopted pursuant to Articles 143 and144 and 
Article 146(4) shall apply to the animal health certification of the movements of the 
products of animal origin referred to in paragraph 1 of this Article.  

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  derogations  from  the  animal  health  certificate  requirements 
provided for in paragraph 1 of this Article and the conditions for such derogations, 
for movements of products of animal origin which do not pose a significant risk for 
the spread of diseases due to:  

(a) 

the types of products of animal origin; 

(b) 

the risk mitigating measures applied to the products of animal origin, thereby 
reducing the risks of the spread of diseases;  

(c) 

the intended use of the products of animal origin;  

(d) 

the place of destination of the products of animal origin.  

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Article 166 
Content of animal health certificates and delegated and implementing acts 

1. 

The  animal  health  certificate  for  products  of  animal  origin  provided  for  in  Article 
165(1) shall contain at least the following information:  

(a) 

the  establishment  or  place  of  origin  and  the  establishment  or  place  of 
destination; 

(b) 

a description of the products of animal origin;  

(c) 

the quantity of the products of animal origin; 

(d) 

(e) 

the identification of the products of animal origin, when required by Article 65 
(1)(h) or rules adopted pursuant to Article 67(a); 

information  needed  to  demonstrate  that  the  products  of  animal  origin  comply 
with the movement restriction requirements provided for in Article 164(2) and 
rules adopted pursuant to Article 164(3). 

2. 

3. 

4. 

The animal health certificate for products of animal origin referred to in paragraph 1 
may include other information required under other Union legislation.  

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  the  information  to  be  contained  in  the  animal  health 
certificate as provided for in paragraph 1 of this Article. 

The  Commission  may,  by  means  of  implementing  acts,  lay  down  rules  concerning 
model forms of animal health certificates for products of animal origin referred to in 
paragraph 1 of this Article. Those implementing acts shall be adopted in accordance 
with the examination procedure referred to in Article 255(2).  

Article 167 
Notification of movements of products of animal origin to other Member States 

1. 

Operators shall: 

(a) 

intended  movement  of 

inform the competent authority in their Member State of origin in advance of 
the 
the 
consignments are required to be accompanied by an animal health certificate in 
accordance with Article 165(1); 

the  products  of  animal  origin  when 

(b)  provide  all  necessary  information  to  enable  the  competent  authority  of  the 
Member  State  of  origin  to  notify  the  movement  of  the  products  of  animal 
origin to the Member State of destination in accordance with paragraph 2. 

The  competent  authority  of  the  Member  State  of  origin  shall  notify  the  competent 
authority  of  the  Member  State  of  destination  of  movements  of  products  of  animal 
origin in accordance with Article 150 and the rules adopted pursuant to Article 151. 

Articles 149 and 150 and rules adopted pursuant to Article 151 shall be applicable to 
the notification of products of animal origin. 

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2. 

3. 

EN 

Chapter 8 
Scope of national measures 

1. 

2. 

Article 168 
National measures concerning movements of animals and germinal products  

Member States shall remain free to take national measures concerning the movement 
of kept terrestrial animals and germinal products thereof within their own territories. 

Those national measures shall: 

(a) 

take account of the rules on movement of animals and germinal products laid 
down in Chapters 3, 4, 5 and 6 and not be in contradiction with those rules; 

(b)  not hinder the movement of animals and products between Member States;  

(c) 

not  exceed  the  limits  of  what  is  appropriate  and  necessary  to  prevent  the 
introduction and spread of the listed diseases referred to in Article 8(1)(d). 

Article 169 
National measures for limiting the impact of diseases other than listed diseases 

Where a disease other than listed diseases constitutes a significant risk for the animal health 
situation of kept terrestrial animals in a Member State, the Member State concerned may take 
national measures to control that disease, provided those measures do not: 

(a) 

(b) 

hinder the movement of animals and products between Member States;  

exceed the limits of what is appropriate and necessary to control that disease. 

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TITLE II  
Aquatic animals and products of animal origin from 
aquatic animals 

Chapter 1 
Registration, approval, record keeping and registers 

SECTION 1 
REGISTRATION OF AQUACULTURE ESTABLISHMENTS 

Article 170  
Obligation of operators to register aquaculture establishments  

1. 

Operators of aquaculture establishments shall, in order to be registered in accordance 
with Article 171, before they commence such activities:  

(a) 

inform  the  competent  authority  of  any  aquaculture  establishment  under  their 
responsibility; 

(b)  provide the competent authority with information on: 

(i) 

the name and address of the operator; 

(ii) 

the location and a description of the facilities; 

(iii) 

the  categories,  species  and  numbers  of  aquaculture  animals  on  the 
aquaculture  establishment  and 
the  aquaculture 
establishment; 

the  capacity  of 

(iv) 

the type of aquaculture establishment; 

(v)  other aspects of the establishment which are relevant in determining the 

risk posed by it.  

2. 

Operators  of  aquaculture  establishments  referred  to  in  paragraph  1  shall  inform  the 
competent authority of any: 

(a) 

significant  changes  in  the  aquaculture  establishments  concerning  the  matters 
referred to in paragraph 1(b); 

(b) 

cessation of activity in the aquaculture establishment. 

3. 

Aquaculture establishments which are subject to approval in accordance with Article 
174(1) shall not be required to provide the information referred to in paragraph 1 of 
this Article. 

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4. 

An operator may apply for a registration provided for in paragraph 1 to cover a group 
of  aquaculture  establishments  provided  that  they  comply  with  the  conditions  laid 
down in either points (a) or (b): 

(a) 

they  are  located  in  an  epidemiologically  linked  area  and  all  operators  in  that 
area operate under a common biosecurity system;  

(b) 

they are under the responsibility of the same operator, and 

(i) 

under a common biosecurity system; and 

(ii) 

located in geographical proximity. 

Where an application for registration covers a group of establishments, the rules laid 
down  in  paragraphs  1  to  3  of  this  Article  and  Article  171(2)  and  the  rules  adopted 
pursuant  to  Article  173,  which  are  applicable  to  a  single  aquaculture  establishment 
shall be applicable to the whole group of aquaculture establishments. 

Article 171  
Obligations of the competent authority concerning the registration of aquaculture 
establishments 

The competent authority shall register:  

(a) 

(b) 

aquaculture establishments in the register of aquaculture establishments provided for 
in  Article  183(1),  where  the  operator  has  provided  the  information  required  in 
accordance with Article 170(1); 

groups  of  aquaculture  establishment  in  that  register  of  aquaculture  establishments 
provided that the criteria laid down in Article 170(4) are complied with. 

Article 172 
Derogations from the obligation of operators to register aquaculture establishments  

By way of derogation from Article 170(1), Member States may exempt certain categories of 
aquaculture  establishments  from  the  registration  requirement  taking  into  account  the 
following criteria: 

(a) 

(b) 

(c) 

the  categories,  species  and  number  or  volume  of  aquaculture  animals  on  the 
aquaculture establishment and the capacity of the aquaculture establishment; 

the type of aquaculture establishment;  

the movements of aquaculture animals into and out of the aquaculture establishment.  

Article 173 
Implementing powers concerning derogations from the obligation to register aquaculture 
establishments 

The Commission may, by means of implementing acts lay down rules concerning: 

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(a) 

(b) 

the information to be provided by operators for the purpose of the registration of the 
aquaculture establishment as provided for in Article 170(1);  

the  types  of  aquaculture  establishments  for  which  the  derogations  from  the 
registration requirement may be granted by Member States as provided for in Article 
172, provided that they pose an insignificant risk and taking into account the criteria 
provided for Article 172. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 255(2). 

SECTION 2 
APPROVAL OF CERTAIN TYPES OF AQUACULTURE ESTABLISHMENTS  

Article 174 
Approval of certain aquaculture establishments and delegated acts 

1. 

Operators  of  the  following  types  of  aquaculture  establishments  shall  apply  to  the 
competent  authority  for  approval  in  accordance  with  Article  178(1)  and  they  shall 
not  commence  their  activities  until  their  aquaculture  establishment  has  been 
approved in accordance with Article 179(1):  

(a) 

aquaculture  establishments  where  aquaculture  animals  are  kept  with  the  view 
to  their  being  moved  from  that  aquaculture  establishment  either  alive  or  as 
products of aquaculture animal origin, however, such application shall  not  be 
required where they are solely moved either for:  

(i) 

for a direct supply for human consumption of small quantities to the final 
consumer; or  

(ii) 

to local retail establishments directly supplying the final consumer. 

(b)  other aquaculture establishments which pose a high risk due to: 

(i) 

the  categories,  species  and  number  of  aquaculture  animals  on  the 
aquaculture establishment;  

(ii) 

the type of aquaculture establishment; 

(iii)  movements  of  aquaculture  animals  into  and  out  of  the  aquaculture 

establishment. 

2. 

Operators  shall  cease  activity  at  an  aquaculture  establishment  referred  to  in 
paragraph 1 where: 

(a) 

(b) 

the competent authority withdraws or suspends its approval in accordance with 
Article 182(2); or  

in the event of conditional approval, granted in accordance with Article 181(3), 
the  outstanding 
the  aquaculture  establishment 

to  comply  with 

fails 

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requirements referred to in Article 181(3) and does not obtain a final approval 
in accordance with Article 182(4).  

3. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  supplementing  and  amending  the  rules  for  the  approval  of 
aquaculture establishments provided for in paragraph 1 of this Article concerning: 

(a) 

derogations  from  the  requirement  for  operators  to  apply  to  the  competent 
authority for approval of the types of aquaculture establishments referred to in 
paragraph 1(a);  

(b) 

the  types  of  aquaculture  establishments  that  must  be  approved  in  accordance 
with paragraph 1(b). 

4. 

The  Commission  shall  take  the  following  criteria  into  account,  when  adopting 
delegated acts provided for in paragraph 3: 

(a) 

the  species  and  categories  of  aquaculture  animals  kept  in  an  aquaculture 
establishment; 

(b) 

the type of aquaculture establishment and the type of production; 

(c) 

typical  movement  patterns  of  the  type  of  aquaculture  establishment  and 
concerned species or category of aquaculture animals. 

5. 

An  operator  may  apply  for  an  approval  of  group  of  aquaculture  establishments 
provided  that  the  requirements  provided  for  in  Article  175(a)  and  (b)  are  complied 
with. 

Article 175 
Approval by the competent authority of group of aquaculture establishments  

The  competent  authority  may  grant  approval  as  provided  for  in  Article  179(1)  covering  a 
group of aquaculture establishments, provided that they comply with the conditions laid down 
in either point (a) or point (b): 

(a) 

they are located in an epidemiologically linked area and all operators operate under a 
common  biosecurity  system;  however,  dispatch  centres,  purification  centres  and 
similar establishments located inside such an epidemiologically linked area must be 
approved individually;  

(b) 

they are under the responsibility of the same operator; and 

(i) 

under a common biosecurity system; and 

(ii) 

located in geographical proximity. 

When  a  single  approval  is  granted  for  a  group  of  aquaculture  establishments,  the  rules  laid 
down in Article 176 and Articles 178 to 182 and the rules adopted pursuant to Articles 178(2) 
and 179(2) which are applicable to a single aquaculture establishment shall be applicable to 
the group of aquaculture establishments. 

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Article 176 
Approval of status of confined aquaculture establishments 

Operators  of  aquaculture  establishments,  who  want  to  obtain  the  status  of  confined 
establishment shall: 

(a) 

(b) 

apply to the competent authority for approval in accordance with Article 178(1); 

not move aquaculture animals to a confined aquaculture establishment in accordance 
with the requirements provided for in Article 203(1) and any delegated acts adopted in 
accordance with Article 203(2) until their establishment obtains an approval of that 
status by the competent authority in accordance with Article 179 or Article 181.  

Article 177 
Approval of disease control aquatic food establishments 

Operators of disease control aquatic food establishments shall ensure that their establishments 
are  approved  by  the  competent  authority  to  slaughter  aquatic  animals  for  disease  control 
purposes in accordance with Article 61(1)(b), Article 62 and Articles 68(1), 78(1) and (2) and 
the rules adopted pursuant to Article 63 and Articles 70(3), 71(3) and 78(3). 

Article 178 
Information obligation of operators in view to obtain approval and implementing acts 

1. 

Operators  shall,  for  the  purposes  of  their  application  for  the  approval  of  their 
establishment provided for in Article 174(1), Article 175, Article 176(a) and Article 
177 provide the competent authority with the information on: 

(a) 

the name and address of the operator; 

(b) 

the location of the establishment and a description of facilities; 

(c) 

the  categories,  species  and  numbers  of  aquaculture  animals  on 
establishment; 

the 

(d) 

the type of establishment; 

(e)  where  relevant,  the  details  of  the  approval  of  a  group  of  aquaculture 

establishments in accordance with Article 175; 

(f) 

other  aspects  of  the  aquaculture  establishment,  which  are  relevant  in 
determining the risk posed by it.  

2. 

Operators  of  establishments  referred  to  in  paragraph  1  shall  inform  the  competent 
authority of any: 

(a) 

significant changes in the establishments concerning the matters referred to in 
paragraph 1(c); 

(b) 

cessation of activity in the establishment. 

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3. 

1. 

The  Commission  may,  by  means  of  implementing  acts,  lay  down  rules  concerning 
the  information  to  be  provided  by  operators  in  the  application  for  the  approval  of 
their  establishment,  in  accordance  with  paragraph  1  of  this  Article.  Those 
implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 255(2). 

Article 179 
Granting of approval and conditions for approval and delegated acts 

The  competent  authority  shall  only  grant  approvals  of  aquaculture  establishment 
referred to in Article 174(1) and, Article 176(a),group of aquaculture establishments 
referred to in Article 175 and disease control aquatic food establishments referred to 
in Article 177 where such establishments: 

(a) 

comply with the following requirements, where appropriate on:  

(i) 

(ii) 

quarantine, isolation and other biosecurity measures taking into account 
the  requirements  provided  for  in  Article  9(1)(b)  and  rules  adopted 
pursuant to Article 9(2);  

surveillance requirements provided for in Article 22 and where relevant 
for the type of establishment and the risk involved, in Article 23, and the 
rules adopted pursuant to Article 24;  

(iii)  record keeping provided for in Articles 185 to 187 and the rules adopted 

pursuant to Articles 188 and 189; 

(b)  have facilities and equipment that are: 

(i) 

adequate to reduce the risk of the introduction and spread of diseases to 
an acceptable level, taking into account the type of establishment; 

(ii)  of adequate capacity for the quantity of aquatic animals; 

(c) 

do  not  lead  to  an  unacceptable  risk  for  the  spread  of  disease,  taking  into 
account the risk mitigating measures in place;  

(d)  have  a  system  in  place  which  enables  the  operator  to  demonstrate  to  the 
competent authority that the requirements laid down in points (a), (b) and (c) 
are fulfilled.  

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning the requirements provided for in paragraph 1 of this Article 
as regards: 

(a) 

quarantine, 
paragraph 1(a)(i);  

isolation  and  other  biosecurity  measures 

referred 

to 

in 

(b) 

surveillance referred to in paragraph 1(a)(ii); 

(c) 

facilities and equipment referred to in paragraph 1(b).  

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3. 

The Commission shall take into account the following matters when establishing the 
rules to be laid down in the delegated acts to be adopted pursuant to paragraph 2: 

(a) 

the risks posed by each type of establishment; 

(b) 

the species and categories of aquaculture or aquatic animals; 

(c) 

the type of production; 

(d) 

typical movement patterns of the type of aquaculture establishment and species 
and categories of animals kept in those establishments. 

Article 180 
Scope of the approval of establishments  

The competent authority shall expressly specify in approvals of aquaculture establishment or 
a disease control aquatic food establishment granted pursuant to Article 179(1): 

(a) 

for  which  of  the  types  of  aquaculture  establishments  referred  to  in  Article  174(1), 
Article  176(a),  groups  of  aquaculture  establishments  referred  to  in  Article  175  and 
disease  control  aquatic  food  establishments  referred  to  in  Article  177,  and  rules 
adopted pursuant to Article 174(3)(b) the approval applies; 

(b) 

for which species and categories of aquaculture animals the approval applies. 

1. 

2. 

3. 

4. 

Article 181 
Procedures for granting the approval by the competent authority  

The  competent  authority  shall  establish  procedures  for  operators  to  follow  when 
applying for approval of their establishments in accordance with Article 174(1) and 
Articles 176 and 177. 

Upon  receipt  of  an  application  for  approval  from  an  operator  in  accordance  with 
Article  174(1),  Article  176  and  Article  177,  the  competent  authority  shall  make  an 
on-site visit. 

The competent authority may grant conditional approval of an establishment where it 
appears, based on the application of the operator and the subsequent on-site visit of 
the establishment by the competent authority as provided for in paragraph 1 of this 
Article, that it meets all the main requirements that provide sufficient guarantees that 
such an establishment does not represent a significant risk, with a view to ensuring 
the  compliance  with  the  outstanding  requirements  for  approval  provided  for  in 
Article 179(1) and the rules adopted pursuant to Article 179(2).  

Where  conditional  approval  has  been  granted  by  the  competent  authority  in 
accordance with paragraph 3 of this Article, it shall grant full approval only where it 
appears  from  another  on-site  visit  of  the  establishment,  carried  out  within  three 
months from the date of granting conditional approval, that the establishment meets 
all the requirements for approval provided for in Article 179(1) and the rules adopted 
pursuant to Article 179(2).  

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Where  that  on-site  visit  shows  that  clear  progress  has  been  made  but  the 
establishment still does not meet all of those requirements, the competent authority 
may  prolong  the  conditional  approval.  However,  conditional  approval  shall  not 
exceed a total period of six months.  

1. 

2. 

3. 

Article 182 
Review, suspension and withdrawal of approvals by the competent authority  

The  competent  authority  shall  keep  the  approvals  of  establishments  granted  in 
accordance with Article 179(1) under review. 

Where the competent authority identifies serious deficiencies in the establishment as 
regards compliance with the requirements laid down in Article 179(1) and the rules 
adopted pursuant to Article 179(2) and the operator is not able to provide adequate 
guarantees  that  those  deficiencies  will  be  resolved,  the  competent  authority  shall 
initiate procedures to withdraw the establishment's approval.  

However,  the  competent  authority  may  suspend  an  establishment's  approval  where 
the operator can guarantee that it will resolve deficiencies within a reasonable period 
of time. 

Approval  shall  only  be  restored  after  withdrawal  or  suspension  in  accordance  with 
paragraph  2  when  the  competent  authority  is  satisfied  that  the  establishment  fully 
complies  with  all  the  requirements  of  this  Regulation,  appropriate  for  that  type  of 
establishment. 

SECTION 3 
REGISTER OF THE COMPETENT AUTHORITY OF AQUACULTURE 
ESTABLISHMENTS AND DISEASE CONTROL AQUATIC FOOD ESTABLISHMENTS 

Article 183 
Register of aquaculture establishments and disease control aquatic food establishments 

1. 

The competent authority shall establish and keep up–to-date a register of:  

(a) 

all aquaculture establishments registered in accordance with Article 171; 

(b) 

all aquaculture establishments approved in accordance with Articles 179(1);  

(c) 

all  disease  control  aquatic  food  establishments  approved  in  accordance  with 
Article 179(1). 

2. 

The register of aquaculture establishments provided for in paragraph 1 shall contain 
information on: 

(a) 

the name and address of the operator and its registration number; 

(b) 

the geographical position of the aquaculture establishment or when applicable, 
the group of aquaculture establishments; 

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(c) 

the type of production at the establishment; 

(d) 

the water supply and discharge of the establishment, when relevant; 

(e) 

the species of aquaculture animals kept at the establishment; 

(f) 

up-to-date  information  on  the  health  status  of  the  registered  aquaculture 
establishment, or when applicable, the group of establishments, as regards the 
listed diseases referred to in Article 8(1)(d).  

3. 

4. 

For  establishments  approved  in  accordance  with  Article  179(1),  the  competent 
authority shall make publicly available by electronic means at least the information 
referred to in paragraph 2(a), (c), (e) and (f) of this Article. 

Where  appropriate  and  relevant,  the  competent  authority  may  combine  the 
registration provided for in paragraph 1 with registration for other purposes. 

Article 184 
Delegation of powers and implementing acts concerning the register of aquaculture 
establishments 

1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 254 concerning:  

(a) 

the  information  to  be  included  in  the  register  of  aquaculture  establishments 
provided for in Article 183(1); 

(b) 

the public availability of that register of establishments. 

2. 

The Commission may, by means of implementing acts, lay down rules on the format 
of  and  procedures  for  the  register  of  establishments  provided  for  in  Article 183(1) 
and (3). 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2).  

SECTION 4 
RECORD KEEPING AND TRACEABILITY 

Article 185  
Record keeping obligations of operators of aquaculture establishments  

1. 

Operators  of  aquaculture  establishments  subject  to  registration  in  accordance  with 
Article  171  or  approval  in  accordance  with  Article  179(1)  shall  keep  up-to-date 
records containing at least the following information: 

(a) 

all movements of aquaculture animals and products of animal origin obtained 
from  those  animals  into  and  out  of  the  aquaculture  establishment,  stating  as 
appropriate: 

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(i) 

their place of origin or destination;  

(ii) 

the date of such movements; 

(b) 

the  animal  health  certificates  in  paper  or  electronic  form  required  to 
accompany  movements  of  aquaculture  animals  arriving  at  the  aquaculture 
establishment in accordance with Article 208 and the rules adopted pursuant to 
Articles 211(b) and (c) and Article 213(2); 

(c) 

the  mortality  in  each  epidemiological  unit  and  other  disease  problems  at  the 
aquaculture establishment as relevant for the type of production;  

(d)  biosecurity  measures,  surveillance,  treatments,  test  results  and  other  relevant 

information as appropriate for:  

(i) 

the category and species of the aquaculture animals on the establishment; 

(ii) 

the type of production at the aquaculture establishment; 

(iii) 

the type of aquaculture establishment; 

(e) 

the results of the animal health visits, when required in accordance with Article 
23(1) and the rules adopted pursuant to Article 24;  

2. 

Operators of aquaculture establishments shall: 

(a) 

record  the  information  provided  for  in  paragraph  1(a)  in  such  a  way  that  the 
tracing  of  the  place  of  origin  and  destination  of  aquatic  animals  can  be 
guaranteed;  

(b)  keep  the  information  provided  for  in  paragraph  1  on  the  aquaculture 
establishment and, made it available to the competent authority on request; 

(c) 

retain the information provided for in paragraph 1 for a minimum period to be 
determined by the competent authority, but which may not be less than a period 
of three years. 

Article 186 
Record keeping obligation for disease control aquatic food establishments 

1. 

Operators  of  disease  control  aquatic  food  establishments  subject  to  approval  in 
accordance  with  Article  177  shall  keep  up-to-date  records  of  all  movement  of 
aquaculture animals and products of animal origin obtained from such animals into 
and out of such establishments. 

2. 

Operators of disease control aquatic food establishments shall: 

(a) 

keep  the  records  provided  for  in  paragraph  1  on  the  disease  control  aquatic 
food  establishment  and  make  them  available  to  the  competent  authority  on 
request; 

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(b) 

retain  the  records  provided  for  in  paragraph  1  for  a  minimum  period  to  be 
determined by the competent authority, but which may not be less than a period 
of three years. 

Article 187 
Record keeping obligation for transporters 

1. 

Transporters  of  aquaculture  animals  and  wild  aquatic  animals  intended  for 
aquaculture shall keep up-to date records on: 

(a)  mortality  rates  of  the  aquaculture  animals  and  wild  aquatic  animals  during 
transport, as practicable for the type of transport and the species of aquaculture 
animals and wild aquatic animals transported; 

(b) 

(c) 

aquaculture  establishments  and  disease  control  aquatic  food  establishments 
visited by the means of transport;  

any exchange of water that took place during transport, specifying the sources 
of new water and sites of release of water. 

2. 

Transporters shall: 

(a) 

(b) 

keep  the  records  provided  for  in  paragraph  1  and  make  them  available  to  the 
competent authority on request; 

retain  the  records  provided  for  in  paragraph  1  for  a  minimum  period  to  be 
determined by the competent authority, but which may not be less than a period 
of three years. 

Article 188 
Delegation of powers concerning record keeping 

1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  rules  supplementing  the  record  keeping  requirements 
provided for in Articles 185, 186 and 187 laying down rules on: 

(a) 

derogations from the record keeping requirements for:  

(i) 

operators  of  certain  categories  of  aquaculture  establishments  and 
transporters; 

(ii) 

aquaculture  establishments  keeping  a  small  number  of  animals  or 
transporters transporting a small number of animals; 

(iii)  certain categories or species of animals; 

(b) 

(c) 

information  to  be  recorded  by  operators  in  addition  to  that  provided  for  in 
Articles 185(1), 186(1) and 187(1); 

the minimum period of time during which records provided for in Articles 185, 
186 and 187 are required must be kept. 

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2. 

The  Commission  shall  take  the  following  matters  into  account  when  adopting  the 
delegated acts provided for in paragraph 1: 

(a) 

the risks posed by each type of aquaculture establishment; 

(b) 

the  categories  or  species  of  aquaculture  animals  on 
establishment; 

the  aquaculture 

(c) 

the type of production of the establishment; 

(d) 

(e) 

typical movement patterns for the type of aquaculture establishment or disease 
control aquatic food establishment; 

the  number  or  volume  of  aquaculture  animals  at  the  establishment  or  being 
transported.  

Article 189 
Implementing powers concerning record keeping 

The Commission may, by means of implementing acts, lay down rules concerning: 

(a) 

(b) 

(c) 

the format of records to be kept in accordance with Articles 185, 186 and 187; 

electronic keeping of those records; 

operational specifications for record-keeping. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 255(2).  

Chapter 2 
Movements within the Union of aquatic animals other than aquatic 
pet animals 

SECTION 1  
GENERAL REQUIREMENTS 

Article 190  
General requirements for movement of aquatic animals  

1. 

Operators  shall  take  appropriate  measures  to  ensure  that  the  movement  of  aquatic 
animals does not jeopardise the health status at the place of destination with regard 
to:  

(a) 

the listed diseases referred to in Article 8(1)(d);  

(b) 

emerging diseases. 

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2. 

Operators  shall  not  move  aquatic  animals  into  an  aquaculture  establishment  or  for 
human  consumption  or  release  them  into  the  wild,  where  such  aquatic  animals  are 
subject to: 

(a)  movement  restrictions  affecting  the  category  and  species  concerned  in 
accordance with the rules laid down in Article 55(1), Article 56, Article 61(1), 
Articles  62,  64  and  65,  Article  70(1)  and  (2),  Articles  74(1),  78(1)  and  (2), 
80(1) and (2) and the rules adopted pursuant to Article 55(2), Articles 63 and 
67, Articles 70(3), 71(3 and 74(3), Article 79, and Articles 80(4) and 81(2); or  

(b) 

the  emergency  measures  laid  down  in  Articles  244  and  247  and  the  rules 
adopted pursuant to Article 248. 

However,  operators  may  move  those  aquatic animals where derogations  from 
the  movement  restrictions  for  such  movements  or  release  are  provided  for  in 
Title  II  of  Part  III  or  derogations  from  emergency  measures  in  rules  adopted 
pursuant to Article 248.  

3. 

Operators  shall  take  all  necessary  measures  to  ensure  that  aquatic  animals,  after 
leaving  their  place  of  origin,  are  consigned  without  delay  to  the  final  place  of 
destination. 

Article 191 
Disease preventive measures in relation to transport and delegated acts 

1. 

Operators  shall  take  the  appropriate  and  necessary  disease  preventive  measures  to 
ensure that: 

(a) 

the health status of aquatic animals is not jeopardised during transport; 

(b) 

(c) 

(d) 

transport  operations  of  aquatic  animals  do  not  cause  the  potential  spread  of 
listed diseases referred to in Article 8(1)(d) to humans or animals en route, and 
at places of destination; 

cleaning, disinfection and disinfestations of equipment and means of transport 
and other adequate biosecurity measures are taken, as appropriate to the risks 
involved with the transport; 

any  exchanges  of  water  during  the  transport  of  aquatic  animals  intended  for 
aquaculture  are  carried  out  at  places  and  under  conditions  which  do  not 
jeopardise  the  health  status  with  regard  to  the  listed  diseases  referred  to  in 
Article 8(1)(d) of: 

(i) 

the aquatic animals being transported; 

(ii) 

any aquatic animals en-route to the place of destination;  

(iii)  aquatic animals at the place of destination. 

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning: 

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(a) 

the  cleaning,  disinfection  and  disinfestations  of  equipment  and  means  of 
transport in accordance with paragraph 1(c) and the use of biocidal products for 
such purposes; 

(b)  other  appropriate  biosecurity  measures  during  transport  as  provided  for  in 

paragraph 1(c); 

(c)  water exchanges during transport as provided for in paragraph 1(d). 

Article 192 
Change of intended use 

1. 

Aquatic animals which are moved for destruction or slaughter in accordance with the 
measures referred to in point (a) or (b) shall not be used for any other purpose: 

(a) 

disease control measures provided for in Articles 31(1) and 55(1), Articles 56, 
61,  62,  64,  65,  67  and  70,  Article  74(1)  and  Articles78  and  80  and  the  rules 
adopted pursuant to Article 55(2), Articles 63 and 66, Articles 70(3), 71(3) and 
74(3), Article 79, and Articles 80(3) and 81(2); 

(b) 

emergency  measures  provided  for  in  Articles  246  and  247  and  rules  adopted 
pursuant to Article 248. 

2. 

Aquatic animals moved for human consumption, aquaculture, release into the wild or 
any other specific purpose, shall not be used for any purpose other than the intended 
one.  

Article 193 
Obligations for operators at the place of destination 

1. 

Operators of establishments and food business establishments receiving aquaculture 
animals shall:  

(a) 

check that one of the following documents are present: 

(i) 

the animal health certificates provided for in Article 208(1), Article 209 
and Article224(1) and the rules adopted pursuant to Articles 188, 211 and 
213 are present;  

(ii) 

the  self-declaration  documents  provided  for  in  Article  218(1)  and  the 
rules adopted pursuant to Article 218(3) and (4) are present;  

(b) 

inform the competent authority of any irregularity with regard to: 

(i) 

the aquaculture animals received; 

(ii) 

the presence of the documents referred to in point (a) (i) and (ii). 

2. 

In  the  event  of  any  irregularity  as  referred  to  in  paragraph  1(b),  the  operator  shall 
isolate  the  aquaculture  animals  concerned  by  that  irregularity  until  the  competent 
authority has taken a decision regarding them. 

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Article 194 
General requirements for movements of aquaculture animals passing through Member States 
but intended for export from the Union to third countries or territories  

Operators  shall  ensure  that  aquaculture  animals  intended  for  export  to  a  third  country  or 
territory and passing through the territory of other Member States fulfil the requirements laid 
down in Articles 190, 191 and 192. 

SECTION 2 
AQUATIC ANIMALS INTENDED FOR AQUACULTURE ESTABLISHMENTS OR TO BE 
RELEASED INTO THE WILD  

Article 195  
Abnormal mortalities or other serious disease symptoms 

1. 

2. 

Operators shall not move aquatic animals from an aquaculture establishment or from 
the  wild  to  another  aquaculture  establishment  or  release  them  into  the  wild  if  they 
originate from an aquaculture establishment or environment where there are:  

(a) 

abnormal mortalities; or  

(b)  other serious disease symptoms with an undetermined cause.  

By way of derogation from paragraph 1, the competent authority may authorise such 
movement  or  release  of  aquatic  animals,  based  on  an  evaluation  of  risks,  provided 
that  the  aquatic  animals  originate  from  a  part  of  the  aquaculture  establishment  or 
from  the  wild  that  is  independent  of  the  epidemiological  unit  where  the  abnormal 
mortalities or other disease symptoms have occurred. 

Article 196 
Movement of aquaculture animals intended for Member States, zones or compartments which 
have been declared disease free or which are subject to an eradication programme and 
delegated acts 

1. 

Operators  shall  only  move  aquaculture  animals  from  an  aquaculture  establishment 
for  the  purposes  referred  to  in  point  (a)  or  (b)  of  this  Article,  if  those  aquaculture 
animals originate from a Member State, or zone or compartment thereof, which has 
been  declared  disease-free  in  accordance  with  Article  36(3)  or  37(4)  for  listed 
diseases referred to in Article 8(1)(b) or (c) when they are of listed species for those 
listed diseases and the aquaculture animals are: 

(a) 

to be introduced into a Member State, or zone or compartment thereof which 
is:  

(i) 

has been declared disease free in accordance with Article 36(3) or Article 
37(4); or  

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(ii) 

subject to a eradication programme as provided for in Article 30(1) and 
(2)  as  regards  one  or  more  of  the  listed  diseases  referred  to  in  Article 
8(1)(b) and (c);  

(b) 

intended for: 

(i) 

an aquaculture establishment subject to:  

– 

– 

registration in accordance with Article 171: or  

approval  in  accordance  with  Articles  174,  175,  176  and  Article 
177; or 

(ii) 

release into the wild.  

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  derogations  from  the  movement  or  release  requirements  of 
paragraph  1  of  this  Article,  which  do  not  pose  a  significant  risk  for  the  spread  of 
listed diseases referred to in Article 8(1)(d due to: 

(a) 

the species, categories, and life stage of the aquaculture animals; 

(b) 

the type of establishment of origin and of destination; 

(c) 

the intended use of the aquaculture animals; 

(d) 

the place of destination of the aquaculture animals; 

(e) 

treatments,  processing  methods  and  other  special  risk  mitigating  measures 
applied at places of origin or destination. 

Article 197 
Derogations by Member States concerning the obligation of operators for movement of 
aquaculture animals between Member States, zones or compartments which are subject to an 
eradication programme 

By way of derogation from Article 196(1), Member States may authorise operators to move 
aquaculture  animals  into  a  zone  or  compartment  in  another  Member  State  for  which  an 
eradication  programme  has  been  established  in  accordance  with  Article  30(1)  and  (2)  as 
regards  the  listed  diseases  referred  to  in  Article  8(1)(b)  and  (c),  from  another  zone  or 
compartment  for  which  such  a  programme  has  also  been  established  for  the  same  listed 
diseases,  provided  that  such  movement  will  not  jeopardise  the  health  status  of  the  Member 
State, zone or compartment of destination. 

Article 198 
Member States' measures concerning the release of aquaculture animals into the wild 

Member  States  may  require  that  aquaculture  animals  shall  only  be  released  into  the  wild  if 
they  originate  from  a  Member  State,  or  zone  or  compartment  declared  disease-free  in 
accordance  with  Article  36(1)  or  Article  37(1)  as  regards  the  listed  diseases  referred  to  in 
Article 8(1)(b) and (c) for which the species of aquaculture animals to be moved is a listed 

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species,  regardless  of  the  health  status  of  the  area  where  the  aquaculture  animals  are  to  be 
released.  

Article 199 
Movement of wild aquatic animals intended for Member States, zones or compartments which 
have been declared disease-free or which are subject to an eradication programme and 
delegated acts 

1. 

2. 

3. 

Articles 196 and 197 shall also apply to movements of wild aquatic animals intended 
for  an  aquaculture  establishment  or  disease  control  aquatic  food  establishment 
subject to:  

(a) 

registration in accordance with Article 171; or  

(b) 

approval in accordance with Articles 174 to 177.  

Operators shall take disease preventive measures when moving wild aquatic animals 
between habitats so that such movements do not pose a significant risk for the spread 
of  listed  diseases  referred  to  in  Article  8(1)(d)  to  aquatic  animals  at  the  place  of 
destination. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning the disease preventive measures to be taken by operators as 
provided for in paragraph 2 of this Article.  

SECTION 3 
AQUATIC ANIMALS INTENDED FOR HUMAN CONSUMPTION  

Article 200  
Movement of aquaculture animals intended for Member States, zones or compartments which 
have been declared disease-free or which are subject to an eradication programme and 
delegated acts 

1. 

Operators  shall  only  move  aquaculture  animals  from  an  aquaculture  establishment 
for the purposes referred to in point (a) or (b) of this paragraph, if those aquaculture 
animals originate from a Member State, or zone or compartment thereof, which has 
been  declared  disease-free  in  accordance  with  Article  36(3)  or  37(4)  for  listed 
diseases referred to in Article 8(1)(b) or (c) when they are of listed species for those 
listed diseases and they are: 

(a) 

to be introduced into a Member State, or zone or compartment thereof which 
has been declared disease free in accordance with Articles 36(3) or 37(4) or for 
which  a  eradication  programme  has  been  established  in  accordance  with 
Article 30(1) or (2) as regards one or more of the listed diseases referred to in 
Article 8(1)(b) and (c);  

(b) 

intended for human consumption. 

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2. 

3. 

By way of derogation from paragraph 1 of this Article Member States may authorise 
operators to introduce aquaculture animals into a zone or compartment for which an 
eradication programme has been established in accordance with Article 30(1) or (2) 
as regards the listed diseases referred to in Article 8(1)(b) and (c), from another zone 
or compartment for which such a programme has also been established as regards the 
same  diseases  within  that  Member  State,  provided  that  such  movement  will  not 
jeopardise the health status of the Member State, or zone or compartment thereof. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning the derogations from movement requirements provided for in 
paragraph 2 of this Article for those movements of aquaculture animals which do not 
pose significant risk of spreading of diseases due to: 

(a) 

the species, categories, and live stage of the aquaculture animals; 

(b) 

the methods of keeping the aquaculture animals and type of production in the 
aquaculture establishments of origin and of destination; 

(c) 

the intended use of the aquaculture animals; 

(d) 

the place of destination of the aquaculture animals; 

(e) 

treatments,  processing  methods  and  other  special  risk  mitigating  measures 
applied at place of origin or place of destination. 

Article 201  
Movement of wild aquatic animals intended for Member States, zones or compartments which 
have been declared disease-free or which are subject to an eradication programme and 
delegated acts 

1. 

2. 

Article  200(1)  and  (2)  and  the  rules  adopted  pursuant  to  Article  200(3)  shall  also 
apply  to  movements  of  wild  aquatic  animals  intended  for  human  consumption  and 
which  are  intended  for  Member  States,  or  zones  or  compartments  thereof,  which 
have  been  declared  disease-free  in  accordance  with  Articles 36(3)  or  37(4)  or  are 
subject to an eradication programme in accordance with Article 30(1) or (2), where 
such measures are necessary to ensure that those wild aquatic animals do not pose a 
significant  risk  for  the  spread  of  listed  diseases  referred  to  in  Article  8(1)(d)  to 
aquatic animals at the place of destination. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning movement requirements for wild aquatic animals intended for 
human consumption supplementing paragraph 1 of this Article. 

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SECTION 4 
AQUATIC ANIMALS NOT INTENDED FOR ESTABLISHMENTS, RELEASE INTO THE 
WILD OR FOR HUMAN CONSUMPTION 

Article 202 
Movement of aquatic animals not intended for establishments, release into the wild or for 
human consumption and delegated acts 

1. 

2. 

3. 

Operators shall take the necessary preventive measures to ensure that movements of 
aquatic  animals not intended for  establishments, release into the wild or for human 
consumption do not pose a significant risk for the spread of listed diseases referred to 
in Article 8(1)(d) to aquatic animals at the place of destination. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning the preventive measures provided for in paragraph 1 of this 
Article to ensure that the aquatic animals do not spread the listed diseases referred to 
in Article 8(1)(d), whilst taking into account the matters referred to in paragraph 3 of 
this Article.  

The  Commission  shall  take  the  following  matters  into  account  when  adopting  the 
delegated acts provided for in paragraph 2:  

(a) 

(b) 

the listed diseases referred to in Article 8(1)(d) relevant for the listed species or 
category of aquatic animals;  

the health status as regards listed diseases referred to in Article 8(1)(d) at the 
compartments, zones or Member States of origin and destination;  

(c) 

the places of origin and of destination; 

(d) 

the type of movements of the aquatic animals;  

(e) 

the species and categories of the aquatic animals;  

(f) 

the age of the aquatic animals; 

(g)  other epidemiological factors. 

SECTION 5 
DEROGATIONS FROM SECTIONS 1 TO 4 AND ADDITIONAL RISK MITIGATION 
MEASURES  

Article 203 
Aquatic animals intended for confined aquaculture establishments and delegated acts  

1. 

Operators shall only move aquatic animals to a confined aquaculture establishment if 
they comply with the following conditions: 

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(a) 

they originate from another confined aquaculture establishment;  

(b) 

they do not pose a significant risk for the spread of listed diseases referred to in 
Article  8(1)(d)  to  listed  species  of  animals  at  the  confined  aquaculture 
establishment of destination except where such movement is authorised for the 
scientific purposes.  

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning: 

(a) 

(b) 

detailed  requirements  for  movements  of  aquaculture  animals  to  confined 
aquaculture establishments in addition to those provided for in paragraph 1 of 
this Article; 

specific  rules  for  movements  of  aquaculture  animals  to  confined  aquaculture 
establishments where the risk mitigating measures in place guarantee that such 
movements do not pose a significant risk for the health of aquaculture animals 
within that confined aquaculture establishment and surrounding establishments. 

Article 204 
Derogation for movements of aquatic animals for scientific purposes and delegated acts 

1. 

2. 

The competent authority of the place of destination may, subject to the agreement of 
the  competent  authority  of  the  place  of  origin,  authorise  movements  into  their 
territory  of  aquatic  animals  for  scientific  purposes,  which  do  not  comply  with  the 
requirements  of  Sections  1  to  4,  with  the  exception  of  Articles  190(1)  and  (3),  and 
Articles 191, 192 and Article 193. 

The  competent  authorities  shall  only  grant  derogations  for  movements  of  aquatic 
animals  for  scientific  purposes,  as  provided  for  in  paragraph  1  under  the  following 
conditions: 

(a) 

the competent authorities of the place of destination and of the place of origin: 

(i) 

have agreed on the conditions for such movements; 

(ii)  have  taken  the  necessary  risk  mitigating  measures  to  ensure  that  the 
movements  of  those  aquatic  animals  do  not  jeopardise  the  health  status 
en route and of the places of destination with regard to the listed diseases 
referred to in Article 8(1)(d);  

(iii)  have notified, where relevant, the competent authority of Member States 
of passage of the derogation granted and the conditions under which this 
authorisation is granted;  

(b) 

the movements of those aquatic animals take place under the supervision of the 
competent authorities of the place of origin, the place of destination, and where 
relevant, the competent authority of the Member State of passage.  

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3. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning amending and supplementing the rules for derogations by the 
competent authorities provided for in paragraphs 1 and 2 of this Article.  

Article 205 
Delegation of power concerning specific requirements and derogations for exhibition, zoos, 
pet shops, garden ponds, commercial aquaria and wholesalers 

The Commission shall be empowered to adopt delegated acts in accordance with Article 253 
concerning: 

(a) 

specific requirement supplementing the rules laid down in from Sections 1 to 4 and 
for the movements of aquatic animals for the following purposes: 

(i) 

zoos, pet shops and wholesalers; 

(ii) 

exhibitions and for sporting, cultural and similar events; or  

(iii) 

intended for commercial aquaria;  

(b) 

derogations  from  Sections  1  to  4  with  the  exception  of  Article 190(1)  and  (3)  and 
Articles 191, 192 and 193 for the movements of aquatic animals referred to in point 
(a). 

Article 206 
Implementing power for temporary derogations for movements of specific species or 
categories of aquatic animals  

The Commission shall, by means of implementing acts lay down rules concerning temporary 
derogations  from  the  rules  laid  down  in  this  Chapter  for  movements  of  specific  species  or 
categories of aquatic animals where: 

(a) 

the movement requirements provided for in Article 195, Article196(1), Articles 197 
and  198,  Article  199(1)  and  (2),  Article  200  and  Articles  201(1),  202(1),  203(1), 
204(1)  and  (2)  and  the  rules  adopted  pursuant  to  Articles  196(2),  199(3),  201(2), 
202(2),  203(2)  and204(3)  and  Article  205  are  not  efficiently  mitigating  the  risks 
posed by certain movements of those aquatic animals; or 

(b) 

the  listed  disease  referred  to  in  Article  8(1)(d)  appears  to  be  spreading  despite  the 
movement requirements laid down in accordance with Sections 1 to 5. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 255(2).  

On duly justified imperative grounds of urgency relating to a listed disease representing a risk 
of highly significant impact and taking into account the matters referred to in Article 205 the 
Commission  shall  adopt  immediately  applicable  implementing  acts  in  accordance  with  the 
procedure provided for in Article 255(3). 

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Article 207 
Matters to be taken into account when adopting delegated and implementing acts provided for 
in this Section 

The Commission shall take the following matters into account, when establishing the rules to 
be laid down in the delegated and implementing acts provided for in Articles 203(2), 204(3) 
and Articles 205 and 206: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

the risks involved with the movement; 

the  health  status  as  regards  the  listed  diseases  referred  to  in  Article  8(1)(d)  at  the 
places of origin and destination; 

listed aquatic animal species for the listed diseases referred to in Article 8(1)(d); 

biosecurity measures in place; 

any specific conditions under which the aquaculture animals are kept;  

specific movement patterns of the type of aquaculture establishment and concerned 
species or category of aquaculture animals; 

(g) 

other epidemiological factors. 

SECTION 6 
ANIMAL HEALTH CERTIFICATION 

Article 208 
Obligation of operators to ensure that aquaculture animals are accompanied by an animal 
health certificate  

1. 

Operators shall only move aquaculture animals if they are accompanied by an animal 
health  certificate  issued  by  the  competent  authority  at  the  place  of  origin  in 
accordance with Article 216(1) when they are of listed species for the listed diseases 
referred to in point (a) and they are being moved or one of following purposes:  

(a) 

they  are  intended  for  introduction  into  a  Member  State,  or  zone  or 
compartment thereof which has been declared disease- free in accordance with 
Articles  36(3)  and  37(4)  or  for  which  a  eradication  programme  has  been 
established as provided for in Article 30(1) or (2) as regards one or more of the 
listed diseases referred to in Article 8(1)(b) and (c); and 

(b) 

they are intended for one of the following purposes: 

(i) 

an aquaculture establishment; 

(ii) 

release into the wild; 

(iii)  human consumption. 

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2. 

Operators shall only move aquaculture animals if they are accompanied by an animal 
health  certificate  issued  by  the  competent  authority  at  the  place  of  origin  in 
accordance  with  Article  216(1)  when  they  are  of  listed  species  for  the  relevant 
disease(s)  referred  to  in  point  (a)  and  they  are  being  moved  or  one  of  following 
reasons: 

(a) 

they are allowed to leave a restricted zone subject to disease control measures 
provided  for  in  Article  55(1)(f)(ii),  Articles  56  and  64,  Articles  65(1),  74(1), 
78(1) and (2) or the rules adopted pursuant to Article 55(2), Articles 67 and68, 
Articles  71(3)  and  74(3),  Article  79,  Article 81(2)  and  Article  248  for  one  or 
more of listed diseases referred to in Article 8(1)(a) and (b);  

(b) 

they are intended for one of the following uses: 

(i) 

an aquaculture establishment; 

(ii) 

released into the wild; 

(iii)  human consumption. 

3. 

Operators  shall  take  all  necessary  measures  to  ensure  that  the  animal  health 
certificate  accompanies  the  aquaculture  animals  from  their  place  of  origin  to  their 
place  of  destination,  unless  specific  measures  are  provided  for  in  rules  adopted 
pursuant to Article 214.  

Article 209 
Obligation of operators to ensure that other aquatic animals are accompanied by an animal 
health certificate and implementing power 

1. 

Operators shall only move aquatic animals other than aquaculture animals referred to 
in  Article  208(1)  and  (2)  if  they  are  accompanied  by  an  animal  health  certificate 
issued  by  the  competent  authority  at  the  place  of  origin  in  accordance  with  Article 
216(1) where, due to the risk involved with the movement of those aquatic animals, 
animal  health  certification  is  necessary  to  ensure  compliance  with  the  following 
movement requirements for the listed species of animals: 

(a) 

the requirements provided for in Sections 1 to 5 and the rules adopted pursuant 
to those Sections;  

(b)  disease  control  measures  provided  for  in  Article  55(1),  Article  56,  Article 
61(1), Articles 62 and 64, Articles 65(1), 74(1) and 78(1) and (2) or the rules 
adopted  pursuant  to  Article  55(2),  Articles  63,  67  and  68,  Articles  71(3)  and 
74(3), Article 79 and Article 81(2); 

(c) 

emergency measures provided for in the rules adopted pursuant to Article 248. 

2. 

Article  208  shall  also  apply  to  wild  aquatic  animals  intended  for  an  aquaculture 
establishment,  unless  the  competent  authority  of  origin  concludes  that  the 
certification  is  not  feasible  due  to  the  nature  of  the  place  of  origin  of  those  wild 
aquatic animals. 

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3. 

The  Commission  shall,  by  means  of  implementing  acts,  lay  down  rules  concerning 
the obligation of operators, provided for in paragraph 2 of this Article, to ensure that 
wild aquatic animals intended for an aquaculture establishment are accompanied by 
an animal health certificate.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2). 

Article 210 
Member States' derogation for national animal health certification  

By  way  of  derogation  from  the  animal  health certification  requirements of Articles 208 and 
209 Member States may grant derogations for movements of certain consignments of aquatic 
animals without an animal health certificate within their territories provided that they have an 
alternative  system  in  place  to  ensure  that  such  consignments  are  traceable  and  they  comply 
with the animal health requirements for such movement provided for in Sections 1 to 5. 

Article 211 
Delegation of powers concerning animal health certification for aquatic animals 

The Commission shall be empowered to adopt delegated acts in accordance with Article 253 
concerning:  

(a) 

derogations  from  the  animal  health  certificate  requirements  provided  for  in 
Articles 208  and  209  and  the  conditions  for  such  derogations,  for  movements  of 
aquatic animals which do not pose significant risk of the spread of diseases due to: 

(i) 

the categories, live stage or species of the aquatic animals;  

(ii) 

the  methods  of  keeping  and  the  type  of  production  of  those  species  and 
categories of aquaculture animals; 

(iii) 

the intended use of the aquatic animals;  

(iv) 

the place of destination of the aquatic animals;  

(b) 

special  rules  for  animal  health  certification  provided  for  in  Articles  208  and  209 
where alternative risk mitigating measures taken by the competent authority, ensure: 

(i) 

the traceability of the aquatic animals;  

(ii) 

that  the  aquatic  animals  being  moved  comply  with  required  animal  health 
conditions provided for in Sections 1 to 5.  

(c) 

detailed rules on the animal health certificates required to accompany movements of 
aquatic animals for scientific purposes referred to in Article 204(1).  

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Article 212 
Contents of animal health certificates 

1. 

The animal health certificate shall contain at least the following information:  

(a) 

the  establishment  or  place  of  origin,  the  establishment  or  place  of  destination 
and  where  relevant  for  the  spread  of  diseases,  any  establishment  or  place 
visited en route; 

(b) 

a description of the aquatic animals;  

(c) 

the number, volume or weight of aquatic animals; 

(d) 

the necessary information needed to demonstrate that the animals comply with 
the movement requirements provided for in Sections 1 to 5. 

2. 

The  animal  health  certificate  may  include  other  information  required  under  other 
Union legislation.  

Article 213 
Delegation of powers and implementing acts concerning the content of animal health 
certificates  

1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  the  content  of  animal  health  certificates  provided  for  in 
Article 212(1): 

(a) 

(b) 

detailed rules on the content of those animal health certificates provided for in 
Article 212(1) for different categories and species of aquatic animals;  

additional information to be contained in the animal health certificate provided 
for in Article 212(1).  

2. 

The  Commission  may,  by  means  of  implementing  acts,  lay  down  rules  concerning 
the model forms for the animal health certificates.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2).  

Article 214 
Operators obligation to ensure that animal health certificates accompany the aquatic animals 
to the place of destination and delegated acts 

The Commission shall be empowered to adopt delegated acts in accordance with Article 253 
concerning specific measures supplementing the requirements for animal health certification 
provided for in Article 208 for the following types of movements of aquatic animals: 

(a) 

movements  of  aquatic  animals,  which  may  not  continue  their  route  to  their  final 
place of destination and are required to return to their place of origin or be moved to 
a different destination, for one or more of the following reasons: 

EN 

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(i) 

their intended route was unexpectedly interrupted for animal welfare reasons;  

(ii)  unpredicted accidents or events on the route; 

(iii) 

the  aquatic  animals  were  rejected  at  the  place  of  the  destination  in  another 
Member State or at the external border of the Union;  

(iv) 

the aquatic animals were rejected in a third country; 

(b) 

movements of aquaculture animals intended for exhibitions and sporting, cultural and 
similar events, and their subsequent return to their place of origin.  

Article 215 
Operators obligation to cooperate with the competent authorities for animal health 
certification purposes 

Operators shall:  

(a) 

(b) 

1. 

provide  the  competent  authority  with  all  the  information  necessary  to  complete  the 
animal health certificate provided for in Articles 208 and 209 and the rules adopted 
pursuant to Articles 211, 213 and 214;  

where  necessary,  subject  the  aquatic  animals  to  identity,  physical  and  documentary 
checks  as  provided  for  in  Article  216(3)  and  the  rules  adopted  pursuant  to  Article 
216(4).  

Article 216 
Competent authority responsibility for animal health certification and delegated acts 

The competent authority shall, upon request by the operator, issue an animal health 
certificate for the movement of aquatic animals, where required by Articles 208 and 
209, or by rules adopted pursuant to that Articles 211 and Article 214 provided that 
the following animal health requirements have been complied with, as relevant: 

(a) 

those  provided  in  Article  190,  Article  191(1),  Articles  192,  194  and  195, 
Article196(1),  Articles  197  and  198,  Article 199(1)  and  (2),  Article  200, 
Articles 202(1), 203(1) and 204(1) and (2); 

(b) 

those  provided  in  delegated  acts  adopted  pursuant  to  Articles  191(2),  196(2), 
199(3), 200(3), 201(2), 202(2), 203(2) and 204(3) and Article 205; 

(c) 

those provided for in implementing acts adopted pursuant to Article 206. 

2. 

Animal health certificates shall: 

(a) 

be verified and signed by the official veterinarian; 

(b) 

remain valid for a period of time, provided for in the rules adopted pursuant to 
paragraph 4(b), during which time the aquaculture animals covered by it, must 
continue to comply with the animal health guarantees contained in it. 

EN 

176 

   EN 

3. 

The official veterinarian shall, before signing an animal health certificate verify that 
the  aquatic  animals  covered  by  it  comply  with  the  requirements  of  this  Chapter  by 
means  of  documentary,  identity  and  physical  checks  as  provided  for  by  delegated 
acts  adopted  pursuant  to  paragraph  4  where  appropriate,  taking  into  account  the 
species  and  categories  of  aquatic  animals  concerned  and  the  animal  health 
requirements. 

4. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 laying down rules concerning:  

(a) 

the  types  of  documentary,  identity  and  physical  checks  and  examinations  for 
different species and categories of aquatic animals that must be carried out by 
the official veterinarian in accordance with paragraph 3 of this Article to verify 
compliance with the requirements of this Chapter;  

(b) 

the timeframes for the carrying out of such documentary, identity and physical 
checks, examination and the issuing of animal health certificates by the official 
veterinarian prior to the movement of consignments of aquatic animals. 

Article 217 
Electronic health certificates 

Electronic animal health certificates, produced, handled and transmitted by means of IMSOC, 
may replace accompanying animal health certificates provided for in Article 208 where such 
electronic animal health certificates: 

(a) 

(b) 

contain  all  the  information  that  the  model  animal  health  certificate  is  required  to 
contain in accordance with Article 212(1) and the rules adopted pursuant to Article 
213;  

ensure the traceability of the aquatic animals and the link between those animals and 
the electronic animal health certificate. 

Article 218 
Self- declaration by operators for movements of aquaculture to other Member States and 
delegated acts 

1. 

Operators  at  the  place  of  origin,  shall  issue  a  self-declaration  document  for 
movements of aquaculture animals from their place of origin in one Member State to 
the place of destination in another Member State and ensure that it accompanies such 
aquaculture  animals,  where  they  are  not  required  to  be  accompanied  by  an  animal 
health certificate provided for in  Articles 208  and  209 or rules adopted pursuant to 
that Articles 211 and Article 214.  

2. 

The self-declaration document provided for in paragraph 1 shall contain at least the 
following information concerning the aquaculture animals: 

(a) 

their places of origin and destination, and when relevant any places en route; 

EN 

177 

   EN 

(b) 

(c) 

a description of the aquaculture animals, the species, their quantity, weight or 
volume as relevant for the animals concerned; 

the  information  needed  to  demonstrate  that  the  aquaculture  animals  comply 
with the movement requirements provided for in Sections 1 to 5. 

3. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning: 

(a) 

detailed  rules  on  the  content  of  the  self-declaration  document  provided  for  in 
paragraph 2  of  this Article  for different species and categories of aquaculture 
animals;  

(b) 

additional information to be contained in the self-declaration document to the 
one provided for in paragraph 2 of this Article.  

4. 

The Commission may, by means of implementing acts, lay down rules for a model 
form of the self-declaration document provided for in paragraph 1 of this Article.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2).  

SECTION 7 
NOTIFICATION OF MOVEMENTS OF AQUATIC ANIMALS TO OTHER MEMBER 
STATES 

Article 219  
Obligation of operators concerning the notification of movements of aquatic animals between 
Member States 

Operators shall notify the competent authority in their Member State of origin in advance of 
the intended movement of aquatic animals from one Member State to another Member State 
where: 

(a) 

(b) 

the  aquatic  animals  are  required  to  be  accompanied  by  an  animal  health  certificate 
issued by the competent authority of the Member State of origin in accordance with 
Articles 208 and 209 or rules adopted pursuant to Article 211 and Article 214(2); 

the  aquatic  animals  are  required  to  be  accompanied  by  an  animal  health  certificate 
for aquatic animals when they are being moved from a restricted zone as referred to 
in Article 208(2)(a); 

(c) 

the aquaculture animals and wild aquatic animals being moved are intended for:  

(i) 

an  establishment  subject  to  registration  in  accordance  with  Article  171  or 
approval in accordance with Articles 174 to 177; 

(ii) 

for release into the wild; 

EN 

178 

   EN 

(d) 

notification  is  required  in  accordance  with  the  delegated  acts  adopted  pursuant  to 
Article 221. 

For  the  purposes  of  the  notification  provided  for  in  the  first  paragraph  of  this  Article,  the 
operators  shall  provide  the  competent  authority  of  the  Member  State  of  origin  with  all  the 
necessary information to enable it to notify the movement to the competent authority of the 
Member State of destination in accordance with Article 220(1). 

Article 220  
The responsibility of the competent authority for the notification of movements of aquatic 
animals to other Member States 

1. 

2. 

3. 

4. 

The  competent  authority  of  the  Member  State  of  origin  shall  notify  the  competent 
authority  of  the  Member  State  of  destination  of  movements  of  aquatic  animals  as 
referred to in Article 219(1), unless a derogation has been granted in accordance with 
Article 221(1)(c) for such notification. 

The  notification  referred  to  in  paragraph  1  of  this  Article  shall  be  carried  out 
whenever possible, through IMSOC.  

Member  States  shall  designate  regions  for  the  management  of  notifications  of 
movements by the competent authority as provided for in paragraph 1 of this Article. 

By way of derogation from paragraph 1, the competent authority of Member State of 
origin  may  authorise  the  operator  to  notify  partially  or  completely  movements  of 
aquatic animals through IMSOC to the competent authority of the Member State of 
destination. 

Article 221 
Delegation of powers and implementing acts for the notification of movements of aquatic 
animals by the competent authority 

1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning:  

(a) 

(b) 

(c) 

the requirement for notification by operators in accordance with Article 219(1) 
of  movements  between  Member  States  of  aquatic  animals  of  categories  or 
species  other  than  those  referred  to  in  Article  219(1)(a),  (b)  and  (c)  where 
traceability  of  such  movements  is  necessary  to  ensure  compliance  with  the 
animal health requirements laid down in this Chapter;  

the information necessary to notify movements of aquatic animals by operators 
and the competent authority as provided for in Articles 219(1) and 220(1); 

derogations  from  the  notification  requirements  provided  for  in  Article 
219(1)(c)  for  categories  or  species  of  aquatic  animals  or  types  of  movements 
which pose an insignificant risk; 

(d) 

the emergency procedures for notification of movements of aquatic animals in 
the case of power cuts or other disturbances of the IMSOC system; 

EN 

179 

   EN 

(e) 

the requirements for the designation of regions by Member States provided for 
in Article 220(3). 

2. 

The Commission may, by means of implementing acts, lay down rules concerning:  

(a) 

the format of notifications by: 

(i) 

(ii) 

operators  to  the  competent  authority  of  the  Member  State  of  origin  of 
movements of aquatic animals in accordance with Article 219(1); 

the  competent  authority  of  the  Member  State  of  origin  to  the  Member 
State of destination of movements of aquatic animals in accordance with 
Article 220(1); 

(b) 

the deadlines for:  

(i) 

the  necessary  information  to  be  provided  to  the  competent  authority  of 
the Member State of origin by operators referred to in Article 219(1);  

(ii) 

the notification of movements by the competent authority of the Member 
State of origin referred to in Article 220(1). 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2).  

Chapter 3 
Movements within the Union of aquatic pet animals  

Article 222 
Non-commercial movements of aquatic pet animals and delegated and implementing acts 

1. 

2. 

3. 

Pet keepers shall only carry out non-commercial movements of aquatic pet animals 
of  the  species  listed  in  Annex  I  if  appropriate  disease  prevention  and  control 
measures  have  been  taken  to  ensure  that  they  do  not  pose  a  significant  risk  for  the 
spread  of  listed  diseases  referred  to  in  Article  8(1)(d)  and  emerging  diseases  to 
animals at the place of destination and during transport. 

Article 112 and the rules laid down in delegated acts pursuant to Article 114(f) and in 
implementing acts adopted pursuant to Article 117 shall apply for the identification, 
registration and traceability of aquatic pet animals. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  the  disease  prevention  and  control  measures  referred  to  in 
paragraph  1  of  this  Article  to  ensure  that  the  aquatic  pet  animals  do  not  pose  a 
significant risk for the spread of diseases referred to in Article 8(1)(d) and emerging 
diseases  to  animals  during  transport  and  at  the  place  of  destination,  when  relevant 
taking into account the health status of the place of destination. 

EN 

180 

   EN 

4. 

The Commission may, by means of implementing acts lay down rules concerning the 
disease prevention and control measures provided for in paragraph 1 of this Article 
and the rules adopted pursuant to paragraph 2 thereof. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2).  

Chapter 4 
Production, processing and distribution within the Union of 
products of animal origin from aquatic animals, other than live 
aquatic animals  

1. 

2. 

Article 223 
General animal health obligations for operators and delegated acts 

Operators shall take appropriate preventive measures to ensure that during all stages 
of  the  production,  processing  and  distribution  of  products  of  animal  origin  from 
aquatic animals, other than live aquatic animals in the Union, those products do not 
cause the spread of:  

(a) 

listed diseases referred to in Article 8(1)(d) taking into account the health status 
of the place of production, processing and destination; 

(b) 

emerging diseases. 

Operators  shall  ensure  that  products  of  animal  origin  from  aquatic  animals,  other 
than  live  aquatic  animals  do  not  come  from  either  establishments  or  food  business 
establishments or are obtained from animals, which come from either establishments 
food business establishments subject to:  

(a) 

emergency  measures  provided  for  in  Articles  246  and  247  and  rules  adopted 
pursuant to Article 248 unless derogations have been provided for those rules 
in Part VI; 

(b)  movement restrictions applicable to the aquatic animals and products of animal 
origin from aquatic animals, as provided for in Articles 31(1) and 55(1), Article 
56,  Article  61(1)(a),  Article  62(1),  Articles  65(1)(c),  70(1)(b)  and  74(1)(a), 
Articles  78(1)  and  (2),  and  80(1)  and  (2)  and  the  rules  adopted  pursuant  to 
Article 55(2), Articles 63 and 67, Articles 71(3) and 74(3) and Article 79 and 
Article  80(3)  and  81(2)  unless  derogation  have  been  provided  for  in  those 
rules. 

3. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  detailed  requirements  supplementing  paragraph  2  of  this 
Article for movements of products of animal origin from aquatic animals other than 
live aquatic animals, taking into account:  

(a) 

the diseases and species of aquatic animals concerned by the disease, for which 
emergency measures or movement restrictions referred to in paragraph 2 apply; 

EN 

181 

   EN 

(b) 

the types of products of animal origin from aquatic animals; 

(c) 

the  risk  mitigating  measures  applied  to  the  products  of  animal  origin  from 
aquatic animals at the places of origin and destination;  

(d) 

the intended use of the products of animal origin from aquatic animals;  

(e) 

the place of destination of the products of animal origin from aquatic animals. 

Article 224 
Animal health certificates and delegated acts 

1. 

Operators  shall  only  move  the  following  products  of  animal  origin  from  aquatic 
animals  other  than  live  aquatic  animals  where  they  are  accompanied  by  an  animal 
health  certificate  issued  by  the  competent  authority  at  the  place  of  origin  in 
accordance with paragraph 3:  

(a) 

products  of  animal  origin  from  aquatic  animals  that  are  allowed  to  leave  a 
restricted  zone  subject  to  emergency  measures  provided  for  in  rules  adopted 
pursuant  to  Article 248  and  such  products  of  animal  origin  originate  from 
aquatic animals of species subject to those emergency measures;  

(b)  products  of  animal  origin  from  aquatic  animals  that  are  allowed  to  leave  a 
restricted  zone  subject  to  disease  control  measures  in  accordance  with  the 
Articles 31(1), Article 55(1)(c), Article 56, Article 61(1)(a), Articles 62(1) and 
63(1), Article 65(1)(c), 70(1)(b) and 74(1)(a), Articles 78(1) and (2), 80(1) and 
(2) and the rules adopted pursuant to Article 55(2), Articles 63 and 67, Articles 
71(3) and 74(3), Article 79 and Articles 80(3) and 81(2) and such products of 
animal origin originate from aquatic animals of species subject to those disease 
control measures. 

Operators  shall  take  all  necessary  measures  to  ensure  that  the  animal  health 
certificate referred to in paragraph 1 accompanies the products of animal origin from 
their place of origin to their place of destination. 

The  competent  authority  shall  upon  request  by  the  operator  issue  an  animal  health 
certificate  for  the  movements  of  products  of  animal  origin  other  than  live  aquatic 
animals referred to in paragraph 1.  

Article 212 and Articles 214 to 217 and the rules adopted pursuant to Article 213 and 
Article  216(4)  shall  apply  to  the  certification  of  movements  of  products  of  animal 
origin other than live aquatic animals, referred to in paragraph 1 of this Article. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  requirements  and  detailed  rules  on  the  animal  health 
certificate  to  accompany  products  of  animal  origin  other  than  live  aquatic  animals, 
referred to in paragraph 1 of this Article taking into account:  

(a) 

the types of products of animal origin; 

2. 

3. 

4. 

5. 

EN 

182 

   EN 

(b) 

the  risk  mitigating  measures  applied  to  the  products  of  animal  origin  which 
reduce the risks of the spread of diseases;  

(c) 

the intended use of the products of animal origin;  

(d) 

the place of destination of the products of animal origin.  

Article 225 
Content of animal health certificates and delegated and implementing acts 

1. 

The  animal  health  certificate  for  products  of  animal  origin  other  than  live  aquatic 
animals shall contain at least the following information:  

(a) 

the  establishment  or  the  place  of  origin  and  the  establishment  or  place  of 
destination; 

(b) 

a description of the products of animal origin;  

(c) 

the quantity or the volume of the products of animal origin; 

(d) 

(e) 

the  identification  of  the  products  of  animal  origin,  when  required  by 
Article 65(1)(h) or rules adopted pursuant to Article 66; 

information  needed  to  demonstrate  that  the  products  of  animal  origin  of  the 
consignment comply with the movement restriction requirements provided for 
in Article 223(2) and rules adopted pursuant to Article 223(3). 

2. 

3. 

4. 

The  animal  health  certificate  for  products  of  animal  origin  other  than  live  aquatic 
animals may include other information required under other Union legislation.  

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning amending and supplementing the information to be contained 
in the animal health certificate as provided for in paragraph 1 of this Article. 

The  Commission  may,  by  means  of  implementing  acts,  lay  down  rules  concerning 
model forms of animal health certificates provided for in paragraph 1 of this Article.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2).  

Article 226 
Notification of movements of products of animal origin to other Member States 

1. 

Operators shall: 

EN 

183 

   EN 

(a) 

inform the competent authority in their Member State of origin in advance of 
the  intended  movement  of  products  of  animal  origin,  other  than  live  aquatic 
animals,  when  the  consignments  are  required  to  be  accompanied  with  an 
animal health certificate in accordance with Article 224(1); 

(b)  provide  all  necessary  information  to  enable  the  competent  authority  of  the 
Member State of origin to notify the movement  of  products  of  animal  origin, 
other  than  live  aquatic  animals,  to  the  Member  State  of  destination  in 
accordance with paragraph 2. 

The  competent  authority  of  the  Member  State  of  origin  shall  notify  the  competent 
authority  of  the  Member  State  of  destination  of  movements  of  products  of  animal 
origin, other than live aquatic animals, in accordance with Article 220(1). 

Articles 219 and 220 and rules adopted pursuant to Article 221 shall be applicable to 
the notification of products of animal origin other than live aquatic animals.  

Chapter 5 
National measures 

Article 227  
National measures for limiting the impact of diseases other than listed disease 

Where a disease other than a listed disease referred to in Article 8(1)(d) constitutes a 
significant risk for aquatic animals in a Member State, the Member State concerned 
may take national measures to prevent the introduction of or to control the spread of 
that disease. 

Member States shall ensure that those national measures do not exceed the limits of 
what  is  appropriate  and  necessary  to  prevent  the  introduction  of  or  to  control  the 
spread of the disease within the Member State. 

Member  States  shall  notify  the  Commission  in  advance  of  any  proposed  national 
measures  referred  to  in  paragraph  1  that  may  affect  movements  between  Member 
States.  

The  Commission  shall  approve  and  if  necessary  amend  the  national  measures 
referred  to  in  paragraph  2  of  this  Article  by  means  of  implementing  acts.  Those 
implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 255(2). 

The  approval  referred  to  in  paragraph  3  shall  only  be  granted  where  the 
establishment  of  movement  restrictions  between  Member  States  is  necessary  to 
prevent  the  introduction  of  or  to  control  the  spread  of  the  disease  referred  to  in 
paragraph 1, taking into account the overall impact of the disease and the measures 
taken on the Union. 

2. 

3. 

1. 

2. 

3. 

4. 

EN 

184 

   EN 

TITLE III 
Animals of species other than those defined as terrestrial 
and aquatic animals, and germinal products and products 
of animal origin from such other animals 

Article 228 
Animal health requirements concerning other animals, and germinal products and products 
of animal origin of such other animals 

Where other animals are listed species for a listed disease referred to in Art 8(1)(d), and those 
other  animals,  or  their  germinal  products  or  products  of  animal  origin  represent  a  risk  to 
public or animal health: the following animal health requirements shall apply: 

(a) 

(b) 

the requirements concerning registration, approval, record keeping and registers for 
establishments and transporters provided for in Chapters 1 of Titles I and II; 

the  requirements  concerning  traceability  provided  for  in  Articles  102  to  105  and 
Articles 112 and 113 for other animals and Article 119 for germinal products;  

(c) 

movement requirements: 

(i) 

(ii) 

for  other  animals  mainly  living  in  terrestrial  environment  or  are  normally 
affected  by  diseases  of  terrestrial  animals,  taking  into  account  the  criteria 
provided for in paragrapah 3(d) and (e) of Article 229, provided for in Section 
1 and Section 6 of Chapter 3 of Title I of Part IV, Chapers 4 and 5 of Title I of 
Part IV;  

for  other  animals  mainly  living  in  aquatic  environment  or  that  are  normally 
affected  by  diseases  of  aquatic  animals,  taking  into  account  the  criteria 
provided  for  in  Article  229(3)(d)  and  (e),  the  requirements  provided  for  in 
Sections 1 to 5 of Chapter 2 of Title II of Part IV and Chapter 2 of Title II; 

(iii)  for other pet animals, the requirements provided for in Articles 112 and 152; 

(iv) 

for germinal products the general requirements for movements provided for in 
Articles  155  and  156  and  the  special  requiremments  for  movements  to  other 
Member States provided for in Articles 162 and 163; 

(v) 

for  products  of  animal  origin,  the  general  animal  health  obligations  for 
operators  for  the  production,  processing  and  distribution  within  the  Union  of 
products of animal origin provided for in Articles 164 and 223;  

(d) 

the following animal health certification obligation for operators and the competent 
authority and self-declaration for operators:  

(i) 

for other animals, pursuant to the rules provided for in Articles 140 to 148 or 
Articles 208 to 218; 

EN 

185 

   EN 

(ii) 

for  germinal  products,  pursuant  to  the  rules  provided  for  in  Articles  159  and 
160; 

(iii)  for products of animal origin, pursuant to the rules provided for in Articles 165 

and 166 or Articles 224 and 225; 

(e) 

notification of movements by operators and by the competent authority, taking into 
account  the  requirements  provided  for  in  Articles 149,  150,151,  161,  167  and  in 
Articles 219 to 221 and 226. 

Article 229 
Delegation of powers and implementing acts concerning animal health requirements for other 
animals, and germinal products and products of animal origin of other animals 

1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  supplementing  and  amending  the  requirements  for  other 
animals, and their germinal products or products of animal origin, as provided for in 
Article 228,  which  are  necessary  to  mitigate  the  risk  of  the  diseases  referred  to 
therein, concerning: 

(a) 

the  requirements  on  registration,  approval,  record  keeping  and  registers  for 
establishments  keeping  or  transporters  transporting  other  animals,  and  their 
germinal  products  or  products  of  animal  origin,  as  provided  for  in  Article 
228(a);  

(b) 

traceability  requirements  for  other  animals  and  their  germinal  products,  as 
provided for in Article 228(b);  

(c)  movement  requirements  for  other  animals  and  their  germinal  products  and 

products of animal origin, as provided for in Article 228(c); 

(d) 

requirements  on  animal  health  certification  obligations  by  operators  and  the 
competent  authority  and  self-declaration  obligations  by  operators  for  other 
animals and their germinal products and products of animal origin, as provided 
for in Article 228(d);  

(e) 

requirements  on  notification  of  movement  by  operators  and  the  competent 
authority for other animals and their germinal products and products of animal 
origin, as provided for in Article 228(e). 

The  Commission  may  adopt  implementing  acts  concerning  detailed  rules  for  the 
implementation  of  the  disease  control  and  prevention  measures  provided  for  in 
paragraph 1 of this Article. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2).  

The Commission shall take one or more of the following criteria into account when 
adopting the delegated acts and implementing acts provided for in paragraphs 1 and 
2: 

2. 

3. 

EN 

186 

   EN 

(a) 

(b) 

(c) 

the species or categories of other animals are listed in accordance with Article 
7(2) as listed species for one or more listed diseases, for which certain disease 
prevention and control measures provided for in this Regulation apply; 

the profile of the listed disease, which concerns species and categories of other 
animals referred to in point (a); 

the feasibility, availability and effectiveness of disease prevention and control 
measures for the listed species concerned by such measures; 

(d) 

the prevailing terrestrial or aquatic living evnvironment of those other animals;  

(e) 

the type of diseases that are affecting such other animals, which can be either 
diseases  normally  affecting  terrestrial  or  normally  affecting  aquatic  animals, 
regardles of the prevailing living environment referred to in point (b).  

EN 

187 

   EN 

PART V 
ENTRY INTO THE UNION AND EXPORT 

Chapter 1 
Entry into the Union of animals, germinal products and products of 
animal origin from third countries and territories  

SECTION 1 
REQUIREMENTS FOR THE ENTRY INTO THE UNION 

Article 230 
Requirements for entry into the Union of animals, germinal products and products of animal 
origin  

1. 

Member  States  shall  only  permit  the  entry  into  the  Union  of  consignments  of 
animals,  germinal  products  and  products  of  animal  origin  from  third  countries  or 
territories if they comply with the following requirements: 

(a) 

(b) 

(c) 

they  come  from  a  third  country  or  territory,  listed  in  accordance  with  Article 
231 for the particular species and category of animals, or germinal products or 
products  of  animal  origin,  or  zone  or  compartment  thereof,  unless  they  are 
covered by a derogation or additional rules adopted pursuant to Article 241(1);  

they  come  from  establishments  which  are  approved  and  listed  where  such 
approval  and  listing  is  required  by  Article  234  and  rules  adopted  pursuant  to 
Article 235;  

they comply with the animal health requirements for entry into the Union laid 
down  in  delegated  acts  adopted  pursuant  to  Article  236(1),  where  such 
requirements  are  laid  down  for  the  animal,  germinal  product  or  product  of 
animal origin of the consignment; 

(d) 

they  are  accompanied  by  an  animal  health  certificate,  declarations  and  other 
documents  where  required  by  Article  239(1)  or  rules  adopted  pursuant  to 
Article 239(4);  

2. 

Operators shall present consignments of animals, germinal products and products of 
animal  origin  from  third  countries  or  territories  for  the  purposes  of  official  control 
provided  for  in  Article  45  of  Regulation  (EU)  No  XXX/XXX  [Publication  office: 
enter  number],  unless  derogation  is  provided  for  pursuant  to  that  Regulation  at  the 
point of entry into the Union. 

EN 

188 

   EN 

SECTION 2 
LISTING OF THIRD COUNTRIES AND TERRITORIES 

Article 231 
Lists of third countries and territories from which the entry into the Union of animals, 
germinal products and products of animal origin is permitted and implementing and 
delegated acts 

1. 

The  Commission  shall,  by  means  of  implementing  acts,  draw  up  lists  of  third 
countries and territories from which the entry into the Union of specific species and 
categories  of  animals,  germinal  products  and  products  of  animal  origin  shall  be 
permitted, taking into account the following criteria: 

(a) 

(b) 

the  animal  health  legislation  of  the  third  country  or  territory  and  the  rules  on 
the  entry  into  that  country  or  territory  of  animals,  germinal  products  and 
products of animal origin from other third countries and territories; 

the  assurances  provided  by  the  competent  authority  of  the  third  country  or 
territory  concerning  the  efficient  implementation  and  control  of  the  animal 
health legislation referred to in point (a); 

(c) 

the  organisation,  structure,  resources  and  legal  powers  of  the  competent 
authority in the third country or territory;  

(d) 

the animal health certification procedures in the third country or territory; 

(e) 

the  animal  health  status  of  the  third  country  or  territory,  or  zones  and 
compartments thereof, with regard to:  

(i) 

listed diseases and emerging diseases;  

(ii) 

any aspects of animal and public health or the environmental situation in 
the third country or territory, or zone or compartment thereof, which may 
pose a risk to the animal or public health or the environmental status of 
the Union; 

(f) 

(g) 

the  guarantees  which  the  competent  authority of  the third country or territory 
can  provide  regarding  compliance  or  equivalence  with  the  relevant  animal 
health requirements applicable in the Union; 

the regularity and speed with which the third country or territory supplies the 
information concerning infectious or contagious animal diseases in its territory 
to the World Organisation for Animal Health (OIE), in particular information 
concerning  the  diseases  listed  in  the  Aquatic  or  Terrestrial  Animal  Health 
Codes of the OIE; 

(h) 

the results of Commission controls carried out in the third country or territory; 

(i) 

any  experience  gathered  from  previous  entries  of  animals,  germinal  products 
and products of animal origin from the third country or territory and the results 

EN 

189 

   EN 

2. 

3. 

of  official  controls  carried  out  at  the  point  of  entry  into  the  Union  on  such 
animals, germinal products and products of animal origin. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2).  

Pending  the  adoption  of  the  lists  of  third  countries  and  territories  provided  for  in 
paragraph  1,  and  provided  that  such  lists  have  not  been  drawn  up  pursuant  to  the 
Union legislation referred to in Article 258(2), Member States shall determine from 
which  third  countries  and  territories  specific  species  or  categories  of  animals, 
germinal products or products of animal origin may enter the Union. 

For the purposes of the first subparagraph, Member States shall take into account the 
criteria  for  inclusion  in  the  lists  of  third  countries  and  territories  provided  for  in 
paragraph 1(a) to (i) of this Article.  

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  derogations  from  paragraph  2  of  this  Article,  limiting  the 
possibility for Member States to decide from which third countries and territories a 
specific species or category of animal, germinal product or product of animal origin 
may enter the Union, where necessary due to the risk posed by that specific species 
or category of animal, germinal product or product of animal origin. 

Article 232 
Information to be included in the lists of third countries and territories  

The Commission shall specify the following information for each third country or territory in 
the lists provided for in Article 231(1): 

(a) 

(b) 

the categories or species of animals, germinal products or products of animal origin 
that may enter the Union from that third country or territory; 

whether  the  animals,  germinal  products  or  products  of  animal  origin  specified  in 
accordance with point (a) may enter the Union from the whole territory of that third 
country or territory or only from one or more zones or compartments thereof. 

Article 233 
Suspension and withdrawal from the list of third countries and territories and implementing 
acts 

1. 

The  Commission  shall,  by  means  of  implementing  acts,  suspend  or  withdraw  from 
the  list  provided  for  in  Article  231(1)  a  third  country  or  territory,  or  zone  or 
compartment thereof, for any of the following reasons: 

(a) 

the third country or territory, or one or more zones or compartments thereof, no 
longer  complies  with  the  criteria  laid  down  in  Article  231(1),  where  relevant 
for  the  entry  into  the  Union  of  a  particular  species  or  category  of  animal, 
germinal product or product of animal origin; 

EN 

190 

   EN 

(b) 

(c) 

the  animal  health  situation  in  the  third  country  or  territory,  or  zone  or 
compartment  thereof  is  such  that  a  suspension  or  withdrawal  from  that  list  is 
necessary to protect the animal health status of the Union;  

in spite of a request of the Commission to the third country or territory for up-
to-date information on the animal health situation and other matters referred to 
in  Article  231(1),  that  third  country  or  territory  has  not  provided  such 
information;  

(d) 

the third country or territory has refused to agree to Commission control being 
carried out on behalf of the Union in its territory. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2).  

On  duly  justified  imperative  grounds  of  urgency  relating  to  a  serious  risk  for  the 
introduction  into  the  Union  of  a  listed  disease  referred  to  in  Article 8(1)(d),  the 
Commission  shall  adopt  immediately  applicable  implementing  acts  in  accordance 
with the procedure referred to in Article 255(3). 

2. 

The  Commission  may,  by  means  of  implementing  acts,  reinsert  a  third  country  or 
territory,  or  zone  or  compartment  thereof,  that  has  been  suspended  or  withdrawn 
from the list provided for in Article 231(1) for one of the following reasons:  

(a) 

(b) 

for the reasons referred to in paragraph 1(a) or (c) of this Article, provided that 
the third country or territory demonstrates that it complies with the criteria for 
being listed provided for in Article 231(1);  

for  the  reasons  referred  to  in  paragraph 1(b)  of  this  Article,  provided  that  the 
third country or territory provides appropriate guarantees that the animal health 
situation that gave rise to that suspension or withdrawal from that list has been 
resolved or no longer represents a threat to the animal or public health of the 
Union;  

(c) 

for the reasons referred to in paragraph 1(d) of this Article, provided that:  

(i) 

(ii) 

the  third  country  or  territory  agreed  to  a  Commission  control  being 
carried out on behalf of the Union in its territory; and 

the  results  of  that  Commission  control  shows  that  the  third  country  or 
territory, and zones or compartments thereof comply with the criteria for 
being listed provided for in Article 231(1).  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2).  

3. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning rules amending and supplementing the criteria for suspension 
and  withdrawal  of  a  third  country  or  territory,  or  zones  or  compartments  thereof, 
from  the  list  provided  for  in  Article  231(1),  as  provided  for  in  paragraph  1  of  this 
Article.  

EN 

191 

   EN 

SECTION 3 
APPROVAL AND LISTING OF ESTABLISHMENTS IN THIRD COUNTRIES AND 
TERRITORIES 

Article 234 
Approval and listing of establishments  

1. 

2. 

3. 

Member States shall only permit the entry into the Union of terrestrial animals and 
germinal  products  thereof  originating  from  a  type  of  establishment  for  which 
approval is required in the Union in accordance with in Article 89(2) and the rules 
adopted  pursuant  to  Article  89(3)  and  Article  90,  if  that  establishment  in  the  third 
country or territory: 

(a) 

complies  with  animal  health  requirements  in  that  third  country  or  territory 
which are equivalent to the rules for that type of establishments applicable in 
the Union; 

(b) 

is  approved  and  listed  by  the  competent  authority  of  the  third  country  or 
territory of dispatch.  

The  Commission  shall  collect  the  lists  of  approved  establishments  referred  to  in 
paragraph  1(b)  received  from  the  competent  authorities  of  the  third  countries  or 
territories. 

The  Commission  shall  provide  to  the  Member  States  any  new  or  updated  lists  of 
approved  establishments  received  from  the  third  countries  or  territories  and  shall 
make them publicly available.  

Article 235 
Delegation of powers for approval and listing of establishments  

The Commission shall be empowered to adopt delegated acts in accordance with Article 253 
concerning rules derogating from the requirements of Article 234(1)(b) where alternative risk 
mitigating measures in place in the third country or territory provide equivalent guarantees for 
the animal health within the Union. 

SECTION 4 
ENTRY INTO THE UNION OF SPECIES AND CATEGORIES OF ANIMALS, GERMINAL 
PRODUCTS AND PRODUCTS OF ANIMAL ORIGIN 

Article 236 
Delegation of powers for animal health requirements for the entry into the Union of species 
and categories of animals, germinal products and products of animal origin 

1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning the animal health requirements for:  

EN 

192 

   EN 

(a) 

(b) 

the  entry  into  the  Union  of  species  and  categories  of  animals,  germinal 
products and products of animal origin from third countries or territories;  

the  movement  within  the  Union  and  handling  of  those  animals,  germinal 
products and products of animal origin after their entry into the Union. 

2. 

The animal health requirements provided for in paragraph 1(a) shall:  

(a) 

be as stringent as the animal health requirements laid down in this Regulation 
and  the  rules  adopted  pursuant  thereto  applicable  to  the  movement  of  the 
species  and  categories  of  animals,  germinal  products  or  products  of  animal 
origin in question within the Union; or 

(b)  be  equivalent  to  the  animal  health  requirements  applicable  to  the  species  and 
categories of animals, germinal products or products of animal origin provided 
for in Part IV of this Regulation. 

3. 

Pending  the  adoption  of  delegated  acts  laying  down  animal  health  requirements  as 
regards  a  particular  species  or  category  of  animal,  germinal  product  or  product  of 
animal  origin,  provided  for  in  paragraph  1  of  this  Article  and  provided  that  such 
requirements  have  not  already  been  laid  down  pursuant  to  the  Union  legislation 
referred to in Article 258(2), Members State may apply national rules, provided that 
those rules:  

(a) 

(b) 

comply with the requirements laid down in paragraph 2 of this Article and take 
the matters referred to in Articles 237 and 238 into account;  

are  not  less  stringent  than  those  which  are  laid  down  in  Titles  I  and  II  of 
Part IV. 

Article 237 
Matters to be taken into account in delegated acts provided for in Article 236 with regard to 
entry into the Union of animals  

The  Commission  shall  take  the  following  matters  into  account  when  laying  down  animal 
health  requirements  in  delegated  acts  provided  for  in  Article 236(1),  for  the  entry  into  the 
Union of particular species and categories of animals: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

the listed diseases referred to in Article 8(1)(d) and emerging diseases;  

the  health  status  of  the  Union  concerning  the  listed  diseases  referred  to  in  Article 
8(1)(d) and emerging diseases; 

the listed species with regard to those listed diseases referred to in Article 8(1)(d) and 
emerging diseases; 

the age and sex of the animals; 

the origin of the animals; 

the  type  of  establishment  and  the  type  of  production  at  the  places  of  origin  and  of 
destination;  

EN 

193 

   EN 

(g) 

(h) 

(i) 

(j) 

(k) 

(l) 

the intended place of destination; 

the intended use of the animals;  

any risk mitigating measures in place in the third countries or territories of origin or 
transit, or after the arrival into the territory of the Union; 

animal  health  requirements  applicable  to  movements  of  those  animals  within  the 
Union; 

other epidemiological factors; 

international animal health trade standards, relevant to the species and categories of 
those animals.  

Article 238 
Matters to be taken into account in delegated acts provided for in Article 236 with regard to 
the entry into the Union of germinal products and products of animal origin  

The Commission shall take the following matters into account when laying down the animal 
health  requirements,  in  delegated  acts  provided  for  in  Article  236(1),  for  the  entry  into  the 
Union of germinal products and products of animal origin:, 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

(i) 

the listed diseases referred to in Article 8(1)(d) and emerging diseases; 

the  health  status  of  the  animals  from  which  the  germinal  products  or  products  of 
animal origin originate and of the Union concerning the listed diseases referred to in 
Article 8(1)(d) and emerging diseases; 

the  type  and  nature  of  particular  germinal  products  or  products  of  animal  origin, 
treatments,  processing  methods  and  other  risk  mitigating  measures  that  have  been 
applied at the place of origin, dispatch of consignment or destination; 

the  type  of  establishment  and  the  type  of  production  at  the  places  of  origin  and  of 
destination; 

the intended place of destination; 

the intended use of the germinal products or products of animal origin;  

animal  health  requirements  applicable  to  movements  of  the  germinal  products  and 
products of animal origin within the Union; 

other epidemiological factors; 

international  animal  health  trade  standards,  relevant  for  the  particular  germinal 
products and products of animal origin. 

EN 

194 

   EN 

SECTION 5 
ANIMAL HEALTH CERTIFICATES, DECLARATIONS AND OTHER DOCUMENTS 

Article 239 
Animal health certificates, declarations and other documents for entry into the Union  

1. 

2. 

3. 

Member  States  shall  only  permit  the  entry  into  the  Union  of  consignments  of 
animals,  germinal  products  and  products  of  animal  origin  provided  they  are 
accompanied by: 

(a) 

an  animal  health  certificate  issued  by  the  competent  authority  of  the  third 
country or territory of origin;  

(b)  declarations or other documents, where required by the rules adopted pursuant 

to paragraph 4(a).  

Member States shall not permit the entry into the Union of consignments of animals, 
germinal products and products of animal origin unless the animal health certificate 
referred to in paragraph 1(a) has been verified and signed by an official veterinarian 
in  a  third  country  or  territory  in  compliance  with  the  certification  requirements 
equivalent to those laid down in Articles 146(3) or 216(3) and rules adopted pursuant 
to Articles 146(4) or 216(4).  

Member  States  shall  permit  electronic  animal  health  certificates  that  are  produced, 
handled  and  transmitted  by  means  of  IMSOC,  to  replace  the  accompanying  animal 
health  certificates  referred  to  in  paragraph  1,  where  such  electronic  animal  health 
certificates:  

(a) 

(b) 

contain  all  the  information  that  the  animal  health  certificate  referred  to  in 
paragraph 1(a) of this Article is required to contain in accordance with Article 
240(1) and rules adopted pursuant to Article 240(3);  

ensure the traceability of the consignments of animals, germinal products and 
products of animal origin and links those consignments to the electronic animal 
health certificate. 

4. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning:  

(a) 

derogations  from  the  animal  health  requirements  provided  for  in  paragraph 
1(a),  for  consignments  of  animals,  germinal  products  and  products  of  animal 
origin  and  specific  rules  for  the  animal  health  certification  of  those 
consignments,  that  pose  an  insignificant  risk  to  the  animal  health  or  public 
health within the Union, due to one or more of the following factors: 

(i) 

the  category  or  species  of  animals,  germinal  products  or  products  of 
animal origin;  

(ii) 

the methods of keeping and types of production of the animals, germinal 
products and products of animal origin; 

EN 

195 

   EN 

(iii) 

their intended use; 

(iv)  alternative  risk  mitigating  measures  which  are  in  place  in  the  third 
countries  or  territories  of  origin  or  transit,  or  after  the  arrival  into  the 
territory  of  the  Union,  providing  equivalent  protection  of  the  animal 
health and public health of the Union provided for in this Regulation; 

(v) 

the  provision  by  the  third  country  or  territory  of  guarantees  that 
compliance  with 
is 
demonstrated by means other than an animal health certificate;  

the  requirements  for  entry 

the  Union 

into 

(b) 

the requirements for consignments of animals, germinal products and products 
of animal origin entering into the Union to be accompanied by declarations or 
other  documents  needed  to  demonstrate  that  the  animals,  germinal  products 
and products of animal origin entering  into the Union meet the animal health 
requirements  for  entry  into  the  Union  laid  down  in  rules  adopted  pursuant  to 
Article 236(1). 

Article 240 
Content of animal health certificates  

1. 

The animal health certificate referred to in Article 239(1)(a) shall contain at least the 
following information:  

(a) 

the name and address of:  

(i) 

the establishment or place of origin;  

(ii) 

the establishment or place of destination;  

(iii)  where  applicable,  establishments  for  assembly  operations  or  rest  of  the 

kept animals; 

(b) 

a description of the animals, germinal products or products of animal origin;  

(c) 

the number or volume of the animals, germinal products or products of animal 
origin; 

(d)  where applicable, the identification and registration of the animals or germinal 

products; 

(e) 

the information needed to demonstrate that the animals, germinal products and 
products  of  animal  origin  in  the  consignment  comply  with  the  animal  health 
requirements  for  entry  into  the  Union  provided  for  in  Article 230  and  Article 
236(3) and the rules adopted pursuant to Article 236(1) and Article 241.  

The  animal  health  certificate  referred  to  in  Article  239(1)(a)  may  include  other 
information required under other Union legislation.  

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning:  

196 

   EN 

2. 

3. 

EN 

(a) 

(b) 

the  information  to  be  contained  in  the  animal  health  certificate  referred  to  in 
Article 239(1)(a) in addition to that referred to in paragraph 1of this Article;  

the information to be contained in declarations or other documents referred to 
in Article 239(1)(b). 

4. 

5. 

The  Commission  may,  by  means  of  implementing  acts,  lay  down  rules  concerning 
model  forms  for  the  animal  health  certificates,  declarations  and  other  documents 
referred to in Article 239(1). Those implementing acts shall be adopted in accordance 
with the examination procedure referred to in Article 255(2).  

Pending  the  establishment  of  rules  in  delegated  and  implementing  acts  adopted 
pursuant  to  paragraph  3  and  4  of  this  Article,  as  regards  a  particular  species  or 
categories  of  animals,  germinal  product  or  product  of  animal  origin,  and  provided 
that such rules have not been laid down pursuant to the Union legislation referred to 
in  Article  258(2),  Members  State  may  apply  national  rules,  provided  they  comply 
with the conditions laid down in paragraph 1 of this Article.  

SECTION 6  
DEROGATIONS AND ADDITIONAL REQUIREMENTS FOR CERTAIN CATEGORIES OF 
ANIMALS, GERMINAL PRODUCTS AND PRODUCTS OF ANIMAL ORIGIN 

Article 241 
Derogations and additional requirements for certain categories of animals, germinal 
products and products of animal origin 

1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  253  concerning  derogations  from  the  requirements  provided  for  in 
Article230(1) and Articles 234 and 239 and additional requirements for the entry into 
the Union of the following:  

(a) 

animals:  

(i) 

intended  for  circuses,  events,  exhibitions,  display,  shows  and  confined 
establishments; 

(ii)  which are pet animals;  

(iii) 

intended to be used for scientific purposes; 

(iv)  for which the Union is not the final destination; 

(v)  which originate in the Union and which are moved to a third country or 
territory, and then are moved back to the Union from that third country or 
territory; 

(vi)  which  originate  in  the  Union  and  which  are  transported  through  a  third 

country or territory en route to another part of the Union;  

EN 

197 

   EN 

(vii)  which  are  intended  for  grazing  purposes  on  a  temporary  basis,  in  the 

vicinity of the Union borders; 

(viii)  which  pose  an  insignificant  risk  to  the  animal  health  status  within  the 

Union; 

(b)  products of animal origin:  

(i) 

intended for personal use;  

(ii) 

for  consumption  on  means  of  transport  arriving  from  third  countries  or 
territories; 

(c) 

germinal products and products of animal origin:  

(i) 

intended to be used as trade samples; 

(ii) 

intended to be used as research and diagnostic samples;  

(iii)  for which the Union is not the final destination; 

(iv)  which  originate  in  the  Union  and  are  moved  to  a  third  country  or 
territory, and then are moved back to the Union from that third country or 
territory; 

(v)  which originate in the Union and are transported through a third country 

or territory en route to another part of the Union;  

(vi)  which  pose  an  insignificant  risk  to  the  animal  health  status  within  the 

Union. 

Those  delegated  acts  shall  take  into  account  the  matters  referred  to  in 
Article 237 and 238. 

2. 

The Commission may, by means of implementing acts, lay down rules: 

(a) 

(b) 

concerning  model  forms  for  the  animal  health  certificates,  declarations  and 
other documents for the categories of animals, germinal products and products 
of animal origin referred to in paragraph 1; 

indicating, for the products referred to in paragraph 1 of this Article, the codes 
from  the  Combined  Nomenclature,  where  such  codes  are  not  provided  for  by 
the  rules  adopted  pursuant  to  Article  45(2)(b)  of  Regulation  (EU)  No. 
XXX/XXX [No to be added…on official controls].  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2).  

EN 

198 

   EN 

Chapter 2 
Entry into the Union of certain goods other than animals, germinal 
products and products of animal origin from third countries and 
territories  

Article 242 
Disease agents and delegated acts 

1. 

Any natural or legal person bringing disease agents into the Union shall:  

(a) 

ensure that their entry into the Union does not pose a risk to animal health or 
public  health  within  the  Union  with  regard  to  listed  diseases  referred  to  in 
Article 8(1)(d) and emerging diseases; 

(b) 

take  appropriate  disease  control  and  preventive  measures  to  ensure  that  entry 
into the Union of those disease agents does not present a risk of bioterrorism.  

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 laying down requirements for the entry into the Union of disease agents 
concerning: 

(a) 

the packaging of disease agents;  

(b)  other  risk  mitigating  measures  required  to  prevent  the  release  and  spread  of 

disease agents. 

Article 243 
Plant material and delegated and implementing acts 

1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning:  

(a) 

specific  animal  health  requirements  for  the  entry  into  the  Union  of  plant 
material, which acts as a path of transmission of listed or emerging diseases; 

(b) 

requirements on:  

(i) 

animal health certification, taking into account the rules provided for in 
Article 239(1)(a) and Article 239 (2) and (3); or  

(ii)  declarations  or  other  documents,  taking  into  account  the  rules  provided 

for in Article 239(1)(b). 

2. 

The  Commission  shall  lay  down  the  animal  health  requirements  provided  for  in 
paragraph  1  of  this  Article  in  the  event  of  a  unfavourable  disease  situation  in  third 
countries  or  territories  concerning  listed  diseases  referred  to  in  Article  8(1)(d)  or 
emerging diseases, and by taking into account the following criteria: 

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(a)  whether a listed or emerging disease that can be transmitted by means of plant 

material representing a serious risk to animal or to human health in the Union; 

(b) 

(c) 

the  likelihood  that  animals  of  listed  species  for  a  particular  listed  disease  or 
emerging  disease  will  be  in  direct  or  indirect  contact  with  the  plant  material 
referred to in paragraph 1; 

the  availability  and  effectiveness  of  alternative  risk  mitigating  measures  in 
relation  to  that  plant  material,  which  may  eliminate  or  minimise  the  risk  of 
transmission referred to in 2(a). 

3. 

The Commission may, by means of implementing acts lay down rules indicating, for 
the  plant  material  referred  to  in  paragraph  1  of  this  Article,  the  codes  from  the 
Combined  Nomenclature,  where  such  indication  is  not  provided  for  by  the  rules 
adopted pursuant to Article 45(2)(b) of Regulation (EU) No. XXX/XXX [Number to 
be added - on official controls]. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2).  

Article 244 
Means of transport, equipment, packaging materials, transport water and feed and fodder and 
delegated and implementing acts 

1. 

2. 

Operators  bringing  animals  and  products  into  the  Union  shall  take  the  appropriate 
and  necessary  disease  preventive  measures  during  transport,  as  provided  for  in 
Articles 122(1) and 191(1). 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning:  

(a) 

specific animal health requirements for the entry into the Union of: 

(a)  means  of  transport  for  animals,  germinal  products,  products  of  animal 

origin, animal by-products and derived products;  

(b) 

equipment,  packaging  material  or  transport  water  for  animals,  germinal 
products,  products  of  animal  origin,  animal  by-products  and  derived 
products, or feed and fodder which may transmit animal diseases;  

(b) 

requirements on:  

(i) 

animal health certification, taking into account the rules provided for in 
Article 239(1)(a) and Article 239 (2) and (3); or 

(ii)  declarations  or  other  documents,  taking  into  account  the  rules  provided 

for in Article 239(1)(b). 

3. 

The  Commission  shall  lay  down  the  animal  health  requirements  provided  for  in 
paragraph 2 in the event of a unfavourable disease situation concerning one or more 

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4. 

1. 

listed  diseases  referred  to  in  Article  8(1)(d)  or  emerging  diseases,  which  present  a 
serious risk to animal and to human health in the Union, in: 

(a) 

a neighbouring third country; 

(b) 

the third country of origin; 

(c) 

a third country of transit. 

The Commission may, by means of implementing acts, lay down rules indicating, for 
the goods referred to in paragraph 2(a) of this Article, the codes from the Combined 
Nomenclature,  where  such  indication  is  not  provided  for  by  the  rules  adopted 
pursuant  to  Article  45(2)(b)  of  Regulation  (EU)  No.  XXX/XXX  [Publication  office: 
No of Regulation] on official controls. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2).  

Chapter 3  
Export  

Article 245 
Export from the Union 

Member States shall take the appropriate measures to ensure that the export and re-
export from the Union to a third country or territory of  animals and products takes 
place  in  accordance  with  the  rules  for  the  movement  of  animals  and  products 
between Member States provided for in Part IV, while taking into account the animal 
health  status  within  the  third  country  or  territory  of  destination,  or  zone  or 
compartment thereof, with regard to the listed diseases referred to in Article 8(1)(d) 
and emerging diseases.  

However, if requested by the competent authority of the importing third country or 
territory, or if established by the laws, regulations, standards, codes of practice and 
other legal and administrative procedures in force in that country or territory, export 
and re-export from the Union may take place in accordance with those provisions.  

2. 

Where  the  provisions  of  a  bilateral  agreement  concluded  between  the  Union  and  a 
third country or territory is applicable, animals and products exported from the Union 
to that third country or territory shall comply with those provisions. 

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PART VI 
EMERGENCY MEASURES  

SECTION 1 
EMERGENCY MEASURES CONCERNING MOVEMENTS OF ANIMALS AND 
PRODUCTS WITHIN THE UNION AND MEANS OF TRANSPORT AND OTHER 
MATERIAL THAT MAY HAVE COME INTO CONTACT WITH SUCH ANIMALS AND 
PRODUCTS 

Article 246 
Emergency measures to be taken by the competent authority of the affected Member State in 
the event of an outbreak of a listed disease or an emerging disease or the occurrence of a 
hazard in their territory 

1. 

In  the  event  of  an  outbreak  of  a  listed  disease  or  an  emerging  disease,  or  the 
occurrence  of  a  hazard  which  is  likely  to  constitute  a  serious  risk,  the  competent 
authority  of the Member State where it occurred shall,  depending on the  gravity of 
the situation and the disease or hazard in question, immediately take one or more of 
the following emergency measures to prevent the spread of the disease or hazard:  

(a) 

for listed diseases: 

(i) 

referred to in Article 8(1)(a) the disease control measures laid down in in 
of Chapter 1 of Title II of Part III;  

(ii) 

referred  to  in  Article  8(1)(b)  and  (c),  the  disease  control  measures  laid 
down in Chapter 2 of Title II of Part III; 

(b) 

for emerging diseases and hazards: 

(i)  movement  restrictions  on  animals  and  products  originating  from  the 
establishments,  or  where  relevant  the  restricted  zones  or  compartments, 
where the outbreak or the hazard occurred, and on means of transport and 
other  material  that  may  have  come  into  contact  with  those  animals  or 
products; 

(ii)  quarantine of animals and isolation of products; 

(iii)  surveillance and traceability measures; 

(iv)  any  emergency  disease  control  measures  provided  for  in  Chapter  1  of 

Title II of Part III that are appropriate; 

(c) 

any  other  emergency  measure  which  it  deems  appropriate  to  effectively  and 
efficiently control and prevent the spread of the disease or hazard.  

2. 

The competent authority referred to in paragraph 1 shall inform the Commission and 
the other Member States:  

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(a) 

immediately  of  an  outbreak  or  the  occurrence  of  a  hazard  referred  to  in 
paragraph 1; 

(b)  without delay of the emergency measures taken pursuant to paragraph 1. 

Article 247 
Emergency measures to be taken by Member States other than the Member State where the 
outbreak or hazard occurred  

1. 

2. 

The  competent  authority  of  Member  States  other  than  the  Member  State  where  the 
outbreak or hazard referred to in Article 246(1) occurred, shall take one or more of 
the emergency measures referred to in Article 246(1), where it detects on its territory 
animals or products from the Member State referred to in Article 246(1) or means of 
transport  or  any  other  material  that  may  have  come  into  contact  with  such  animals 
and products. 

The  competent  authority  referred  to  in  paragraph  1  of  this  Article  may,  where  a 
serious risk exists pending the adoption of emergency measures by the Commission 
in accordance with Article 248, take the emergency measures referred to in Article 
246(1) on an interim basis, depending on the gravity of the situation with regard to 
animals  or  products  originating  from  the  establishments  or  any  other  locations,  or 
where  relevant  from  the  restricted  zones  of  the  Member  State  where  the  disease  or 
hazard referred to in Article 246(1) occurred, or means of transport or other material 
that may have come into contact with such animals.  

3. 

The competent authority referred to in paragraph 1 shall inform the Commission and 
other Member States: 

(a) 

immediately of the outbreak or occurrence of a hazard referred to in paragraph 
1; 

(b)  without delay of the emergency measures taken pursuant to paragraphs 1 and 2. 

Article 248 
Commission emergency measures  

1. 

In  the  event  of  an  outbreak  or  the  occurrence  of  a  hazard,  as  referred  to  in  Article 
246(1)  and  of  emergency  measures  taken  by  the  competent  authorities  of  the 
Member  States  in  accordance  with  Articles  246(1)  and  247(1)  and  (2),  the 
Commission shall review the situation and the emergency measures taken, and adopt, 
by means of an implementing act one or more of the emergency measures provided 
for in Article 246(1) concerning the animals and products and means of transport and 
other  material  that  may  have  come  into  contact  with  those  animals  or  products,  in 
any of the following cases: 

(a) 

(b) 

the  Commission  has  not  been  informed  of  any  measures  taken  pursuant  to 
Article 246(1) and Article 247(1) and (2); 

the  Commission  considers  the  measures  taken  pursuant  to  Article  246(1)  and 
Article 247(1) and (2) to be inadequate; 

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(c) 

the  Commission  considers  it  necessary  to  approve  or  replace  the  measures 
taken  by  the  competent  authorities  of  the  Member  States  pursuant  to 
Articles 246(1) and 247(1) and (2) in order to avoid unjustified disruptions in 
the movement of animals and products. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2). 

2. 

On  duly  justified  imperative  grounds  of  urgency  relating  to  serious  risks  of  the 
spread of a disease or a hazard the Commission  may  adopt  immediately  applicable 
implementing acts in accordance with Article 255(3). 

SECTION 2 
EMERGENCY MEASURES CONCERNING CONSIGNMENTS OF ANIMALS AND 
PRODUCTS ORIGINATING FROM THIRD COUNTRIES AND TERRITORIES AND 
MEANS OF TRANSPORT AND OTHER MATERIAL THAT MAY HAVE COME INTO 
CONTACT WITH SUCH CONSIGNMENTS 

Article 249 
Emergency measures to be taken by the competent authority of the Member State 

Where  the  competent  authority  of  a  Member  State  becomes  aware  of  a  consignment  of 
animals  or  products  originating  from  a  third  country  or  territory,  or  means  of  transport  or 
materials  which  may  have  come  into  contact  with  such  a  consignment,  that  is  likely  to 
constitute  a  serious  risk  in  the  Union  due  to  possible  infection  or  contamination  by  listed 
diseases or emerging diseases or hazards, it shall immediately:  

(a) 

take one or more of the following emergency measures necessary to mitigate that risk 
depending on the gravity of the situation: 

(i) 

destruction of the consignment; 

(ii)  quarantine of animals and isolation of products; 

(iii)  surveillance and traceability measures; 

(iv)  any  disease  control  measures  referred  to  in  Chapter 1  of  Title  II  of  Part  III, 

where appropriate; 

(v) 

any other emergency measure which it deems appropriate to prevent the spread 
of the disease or a hazard into the Union;  

(b) 

immediately  inform  the  Commission  and  the  other  Member  States  of  the  risks 
associated with the consignment in question and of the origin of the consignment by 
means of IMSOC. 

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Article 250 
Commission emergency measures  

1. 

Where a listed disease, an emerging disease or a hazard that is likely to constitute a 
serious risk occurs or spreads in a third country or territory, or if any other serious 
animal  or  public  health  reason  so  warrants,  the  Commission  may,  by  means  of  an 
implementing act and acting on its own initiative or at the request of a Member State, 
adopt  one  or  more  of  the  following  emergency  measures  and,  depending  on  the 
gravity of the situation:  

(a) 

(b) 

suspend the entry into the Union of consignments of animals and products, and 
means of transport or other material that may have come into contact with such 
consignments, which may spread that disease or hazard into the Union;  

establish special requirements for the entry into the Union of consignments of 
animals and products and means of transport and other material that may have 
come  into  contact  with  such  consignments,  which  may  spread  that  disease  or 
hazard into the Union;  

(c) 

take any other appropriate emergency disease control measures to prevent the 
spread of that disease or hazard into the Union.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2). 

On  duly  justified  imperative  grounds  of  urgency  relating  to  serious  risks,  the 
Commission shall after consulting the Member State concerned, adopt immediately 
applicable  implementing  acts  in  accordance  with  the  procedure  referred  to  in 
Article 255(3).  

Article 251 
Emergency measures taken by the Member States when the Commission does not act  

Where  a  Member  State  requests  the  Commission  to  take  emergency  measures  in 
accordance  with  Article  250  and  the  Commission  has  not  done  so,  that  Member 
State:  

(a)  may,  pending  the  adoption  of  emergency  measures  by  the  Commission  in 
accordance  with  paragraph  2  of  this  Article,  take  one  or  more  emergency 
measures referred to in point (a) of Article 249 on an interim basis in respect of 
the  consignments  of  animals  and  products  and  means  of  transport  and  other 
material that may have come into contact with such consignments, originating 
from  the  third  country  or  territory  referred  to  in  Article  250(1)  depending  on 
the gravity of the situation within its territory;  

(b) 

shall  inform  the  Commission  and  the  competent  authorities  of  the  other 
Member States of such emergency measures without delay, giving the reason 
for their adoption.  

2. 

1. 

2. 

The Commission shall review the situation and the emergency measures taken by the 
Member  State  in  accordance  with  paragraph  1  of  this  Article  and  shall,  where 

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necessary adopt by means of an implementing act one or more emergency measures 
provided for in Article 250. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 255(2). 

3. 

On  duly  justified  imperative  grounds  of  urgency  relating  to  serious  risks,  the 
Commission  shall  adopt  immediately  applicable  implementing  acts  in  accordance 
with the procedure referred to in Article 255(3).  

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PART VII 
COMMON PROVISIONS 

TITLE I 
Procedural provisions 

Article 252  
Amendment to Annexes I and II 

The Commission shall be empowered to adopt delegated acts in accordance with Article 253 
concerning  amendments  to  Annexes  I  and  II  in  order  to  take  account  of  technical  progress, 
scientific developments and changed circumstances in public and animal health. 

Article 253 
Exercise of the delegation 

1. 

2. 

3. 

4. 

The  power  to  adopt  delegated  acts  is  conferred  on  the  Commission  subject  to  the 
conditions laid down in this Article. 

The  power  to  adopt  delegated  acts  referred  to  in  Articles  4(2),  6(2),  9(2),  11(3), 
13(2), 15(2), 16(3), 18(3), 24, 28, 30(4), 31(2), 34(2), 37(5), 39, 41(3), 42(5), 44(1), 
47, 48(3), 53(2), 54(3), 55(2), 58(2), 63, 64(4), 67, 68(2), 70(3), 72(2), 73(3), 74(3), 
76(2), 79, 80(4), 85(3), 89(3), 92(2), 96(3), 100(1), 103(2), 114, 115, 119(1), 122(2), 
128(1), 129(2), 132, 133(2), 134(2), 135(3), 136(4), 137, 141(1), 143(1), 144, 146(4), 
148(3), 151(1), 152(2), 154(1), 158, 159(5), 160(3), 162(2), 163(3), 164(3), 165(5), 
166(3),  174(3),  179(2),  184(1),  188(1),  191(2),  196(2),  199(3),  200(3),  201(2), 
202(2), 203(2), 204(3), 205, 211, 213(1), 214, 216(4), 218(3), 221(1), 222(3), 223(3), 
224(5), 225(3), 229(1), 231(3), 233(3), 235, 236(1), 239(4), 240(3), 241(1), 242(2), 
243(1), 244(2), 252, 259(2), 260(2) and 261(2) shall be conferred on the Commission 
for an indeterminate period of time from(*). 

The power to adopt delegated acts referred to in Article 229(1) shall be conferred on 
the Commission for a period of five years from (*). 

(*)  Date of entry into force of the basic legislative act or any other date set by the 

legislator. 

The delegation of power listed in paragraph 1 of this Article and referred to in Article 
229(1) may be revoked at any time by the European Parliament or by the Council. A 
decision  of  revocation  shall  put  an  end  to  the  delegation  of  the  power  specified  in 
that decision. It shall take effect the day following the publication of the decision in 
the Official Journal of the European Union or at a later date specified therein. It shall 
not affect the validity of any delegated acts already in force. 

5. 

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council. 

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6. 

1. 

2. 

1. 

2. 

3. 

A delegated act adopted pursuant to provisions listed in paragraph 2 of this Article 
and  pursuant  to  Article  229(1)  shall  enter  into  force  only  if  no  objection  has  been 
expressed either by the European Parliament or by the Council within a period of two 
months of notification of that act to the European Parliament and the Council or if, 
before the expiry of that period, the European Parliament and the Council have both 
informed the Commission that they will not object. That period shall be extended by 
two months at the initiative of the European Parliament or the Council.  

Article 254 
Urgency procedure 

Delegated  acts  adopted  under  this  Article  shall  enter  into  force  without  delay  and 
shall apply as long as no objection is expressed in accordance with paragraph 2. The 
notification  of  a  delegated  act  to  the  European  Parliament  and  to  the  Council  shall 
state the reasons for the use of the urgency procedure. 

Either  the  European  Parliament  or  the  Council  may  object  to  a  delegated  act  in 
accordance  with  the  procedure  referred  to  in  Article  253(6).  In  such  a  case,  the 
Commission  shall  repeal  the  act  without  delay  following  the  notification  of  the 
decision to object by the European Parliament or by the Council. 

Article 255 
Committee procedure 

The  Commission  shall  be  assisted  by  the  Standing  Committee  on  Plants,  Animals, 
Food  and Feed  established by Article  58(1) of Regulation (EC) No 178/2002. That 
committee  shall  be  a  committee  within  the  meaning  of  Regulation  (EU)  No 
182/2011. 

Where  reference  is  made  to  this  paragraph,  Article  5  of  Regulation  (EU)  No 
182/2011 shall apply. 

Where  reference  is  made  to  this  paragraph,  Article  8  of  Regulation  (EU)  No 
182/2011, in conjunction with Article 5 thereof, shall apply. 

TITLE II 
Penalties 

Article 256 
Penalties 

The Member  States  shall  lay  down  the rules on penalties  applicable to  infringements  of the 
provisions of this Regulation and shall take all measures necessary to ensure that those rules 
are implemented. The penalties provided for must be effective, proportionate and dissuasive. 

The Member States shall notify those provisions to the Commission by [date to be inserted: 
one  year  from  the  date  of  application  of  this  Regulation]  at  the  latest  and  shall  notify  it 
without delay of any subsequent amendments affecting them. 

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TITLE III 
Member States measures 

Article 257 
Member States measures 

1. 

Member  States  may  apply  additional  or  more  stringent  measures  within  their 
territories than those laid down in this Regulation concerning only:  

(a) 

responsibilities for animal health provided for in Chapter 3 of Part I; 

(b)  notification within Member States provided for in Article 16; 

(c) 

surveillance provided for in Chapter 2 of Part II; 

(d) 

(e) 

registration, approval, record keeping and registers provided for in Chapter 1 of 
Titles I and Chapter 1 of Title II of Part IV; 

traceability  requirements  for  kept  terrestrial  animals  and  germinal  products 
provided for in Chapter 2 of Title I of Part IV. 

2. 

The  national  measures  referred  to  in  paragraph  1  shall  be  in  accordance  with  the 
rules laid down in this Regulation and shall not: 

(a) 

hinder the movement of animals and products between Member States; 

(b)  be in contradiction with the rules referred to in paragraph 1.  

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PART VIII 
TRANSITIONAL AND FINAL PROVISIONS 

Article 258 
Repeals 

1. 

2. 

Decision  78/642/EEC,  Directive  79/110/EEC,  Directive  81/6/EEC,  Decision 
89/455/EEC, Directive 90/423/EEC, Decision 90/678/EEC are repealed. 

The following acts are repealed as from [the date of application of this Regulation]: 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

Directive 64/432/EEC,  

Directive 77/391/EEC,  

Directive 78/52/EEC,  

Directive 80/1095/EEC,  

Directive 82/894/EEC,  

Directive 88/407/EEC, 

Directive 89/556/EEC, 

Directive 90/429/EEC,  

Directive 91/68/EEC,  

Decision 91/666/EEC, 

Directive 92/35/EEC,  

Directive 92/65/EEC,  

Directive 92/66/EEC, 

Directive 92/118/EEC, 

Directive 92/119/EEC, 

Decision 95/410/EC,  

Directive 2000/75/EC, 

Decision 2000/258/EC,  

Regulation (EC) No 1760/2000,  

Directive 2001/89/EC, 

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– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

Directive 2002/60/EC,  

Directive 2002/99/EC,  

Directive 2003/85/EC,  

Regulation (EU) No[XXX/XXX [Publication office: Number to be inserted… 
non-commercial movements of pet animals and repealing Regulation (EC) No 
998/2003],  

Regulation (EC) No 21/2004,  

Directive 2004/68/EC,  

Directive 2005/94/EC, 

Directive 2006/88/EC, 

Directive 2008/71/EC,  

Directive 2009/156/EC, 

Directive 2009/158/EC.  

References to those repealed acts shall be construed as references to this Regulation 
and shall be read in accordance with the correlation table set out in Annex III hereto.  

3. 

The  acts  adopted  by  the  Commission  pursuant  to  the  acts  of  the  Council  and  the 
European Parliament referred to in paragraph 2 shall remain in force in so far as they 
are not in contradiction with the rules laid down in this Regulation. 

Article 259 
Transitional measures related to the repeal of Regulation (EC) No 1760/2000, Regulation 
(EC) No 21/2004 and Directive 2008/71/EC 

1. 

2. 

Notwithstanding Article 258(2) of this Regulation, Regulations (EC) No 1760/2000, 
and (EC) No 21/2004 and Directive 2008/71/EC shall continue to apply until the date 
to be determined in a delegated act adopted in accordance with paragraph 2 of this 
Article. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 252 concerning the date on which the acts referred to in paragraph 1 of this 
Article shall no longer apply.  

That  date  shall  be  the  date  of  application  of  the  corresponding  rules  to  be  adopted 
pursuant  to  the  delegated  acts  provided  for  in  Article  103(2)  and  Articles  114  and 
115 of this Regulation. 

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Article 260 
Transitional measures related to the repeals of Directives 92/66/EEC, 2000/75/EC, 
2001/89/EC, 2000/75/EC, 2002/60/EC, 2003/85/EC and 2005/94/EC  

1. 

2. 

Notwithstanding  Article  258(2)  of 
this  Regulation,  Directives  92/66/EEC, 
2000/75/EC,  2001/89/EC,  2000/75/EC,  2002/60/EC,  2003/85/EC  and  2005/94/EC 
shall continue to apply until the date to be determined in a delegated act adopted in 
accordance with paragraph 2 of this Article. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 253 concerning the date on which the Directives referred to in paragraph 1 of 
this Article shall no longer apply.  

That date shall be the date of the application of the corresponding rules to be adopted 
pursuant to the delegated acts provided for in Articles 44(1), 47(1) 48(3), 53(1) 54(3) 
and 58(2), Article 63, Article 64(4), Article 67, and Articles 68(2) and 70(3) of this 
Regulation. 

Article 261 
Transitional measures related to the repeal of Regulation (EU) No [XXX/XXX on the non-
commercial movement of pet animals] 

1. 

2. 

Notwithstanding Article 258(2) of this Regulation, Regulation (EU) No [XXX/XXX] 
shall continue to apply until the date to be determined in a delegated act adopted in 
accordance with paragraph 2 of this Article. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  to 
Article 253  concerning  the  date  on  which  Regulation  XXX/XXX  shall  no  longer 
apply.  

That date shall be the date of the application of the corresponding rules to be adopted 
pursuant to the delegated acts provided for in Article 114(f), and Articles 152(2) and 
222(3) of this Regulation. 

Article 262 
Entry into force and application 

This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

It shall apply from 36 months from the date of entry into force of the Regulation. 

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This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

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ANNEX I  

Species of pet animals 

PART A 

Dogs (Canis lupus familiaris) 

Cats (Felis silvestris catus) 

Ferrets (Mustela putorius furo) 

PART B 

Invertebrates (except bees, and bumble bees and molluscs and crustaceans)  

Ornamental aquatic animals  

Amphibia 

Reptiles 

Birds: all species of birds except poultry  

Mammals: rodents and rabbits other than those intended for food production.  

EN 

214 

   EN 

ANNEX II 

Species of Ungulates 

Taxon 

Order 

Family 

Genera/Species 

Perissodactyla 

Equidae 

Tapiridae 

Rhinoceritidae 

Equus spp. 

Tapirus spp. 

Ceratotherium  spp.,  Dicerorhinus  spp.,  Diceros  spp., 
Rhinoceros spp. 

Artiodactyla 

Antilocapridae 

Antilocapra ssp. 

Bovidae 

ssp.,  Capra 

ssp.,  Aepyceros 

ssp.,  Alcelaphus 

Addax 
ssp., 
Ammodorcas  ssp.,  Ammotragus  ssp.,  Antidorcas  ssp., 
Antilope  ssp.,  Bison  ssp.,  Bos  ssp.(including  Bibos, 
Novibos,  Poephagus),  Boselaphus  ssp.,  Bubalus  ssp. 
(including  Anoa),  Budorcas 
ssp., 
Cephalophus  ssp.,  Connochaetes  ssp.,  Damaliscus 
ssp.(including  Beatragus),  Dorcatragus  ssp.,  Gazella 
ssp.,  Hemitragus  ssp.,  Hippotragus  ssp.,  Kobus  ssp., 
Litocranius  ssp.,  Madogua  ssp.,  Naemorhedus  ssp. 
(including  Nemorhaedus  and  Capricornis),  Neotragus 
ssp.,  Oreamuos  ssp.,  Oreotragus  ssp.,  Oryx  ssp., 
Ourebia  ssp.,  Ovibos  ssp.,  Ovis  ssp.,  Patholops  ssp., 
Pelea  ssp.,  Procapra  ssp.,  Pseudois  ssp.,  Pseudoryx 
ssp.,  Raphicerus  ssp.,  Redunca  ssp.,  Rupicapra  ssp., 
Saiga  ssp.,  Sigmoceros-Alecelaphus  ssp.,  Sylvicapra 
ssp.,  Syncerus  ssp.,  Taurotragus  ssp.,  Tetracerus  ssp., 
Tragelaphus ssp. (including Boocerus). 

Camelidae 

Cervidae 

Camelus ssp., Lama ssp., Vicugna ssp. 

Alces  ssp.,  Axis-Hyelaphus  ssp.,  Blastocerus  ssp., 
Capreolus  ssp.,  Cervus-Rucervus  ssp.,  Dama  ssp., 
Elaphurus  ssp.,  Hippocamelus  ssp.,  Hydropotes  ssp., 
Mazama  ssp.,  Megamuntiacus  ssp.,  Muntiacus  ssp., 
Odocoileus  ssp.,  Ozotoceros  ssp.,  Pudu  ssp.,  Rangifer 
ssp. 

Giraffidae 

Giraffa ssp., Okapia ssp. 

Hippopotamindae  Hexaprotodon-Choeropsis ssp., Hippopotamus ssp.  

Moschidae 

Moschus ssp. 

Suidae 

Babyrousa  ssp.,  Hylochoerus  ssp.,  Phacochoerus  ssp., 
Potamochoerus ssp., Sus ssp., 

Tayassuidae 

Catagonus ssp., Pecari-Tayassu ssp. 

Tragulidae 

Hyemoschus ssp., Tragulus-Moschiola ssp. 

Proboscidae 

Elephantidae 

Elephas ssp., Loxodonta ssp. 

EN 

215 

   EN 

 
ANNEX III 

Correlation table referred to in Article 257 (2) 

1. 

Directive 64/432/EC 

Directive 64/432/EEC 

This Regulation 

Article 1 

Article 2 

Article 3(1) 

Article 3(2) 

Article 4(1) 

- 

Articles 4 (partially), 150(3) and 220(3)  

Articles 121 and 123 

Articles 121 (2), 123(1) and 146(3) and (4) 

Article 121(1) 

Article 4(2) and (3) 

Article 122(1) and (2) 

Article 5(1) 

Article 5(2) 

Article 5(2)(a) 

Article 5(2)(b) 

Article 5(3) 

Article 5(4) 

Article 5(5) 

Article 6 

Article 6a 

Article 7 

Article 8 

Article 9 

Article 10 

Article 140(1), 142 and 143,  

Article 146(3) and (4),  

Article 144(a)  

Article 141(1)(b),  

Article 146(3) and (4),  

Article 150,  

Articles 130, 132 and 150 

Articles 127, 128, 129  

- 

Articles 129, 130, 131(a) and 132 

Articles 16, 17, 18 and Articles 16(3), 17(3), 
18(3) and 19 

Articles 30(1), 31, 32 and Article 30 (3) and 
(4), 31(2) 

Articles 30(2), 31, 32, 36, 41, 42 and Articles 
39, 40, 41(3) and 42(5) and (6)  

Article 11(1) 

Article 89(1)(a), 92, 93 and Article 92(2),  

EN 

216 

   EN 

Article 11(2) 

Article 11(3) 

Article 11(4) 

Articles 97, 100 and 101 

Article 93, 94  

Article 95 

Article 11(5)-(6) 

Article 92(1)(d) and (2)(d) 

Article 12(1) 

Article 12(2) 

Article 12(3) 

Article 12(4) 

Article 12(5) and (6) 

Article 13(1) and (2) 

Article 13(3) 

Article 13(4) 

Article 13(5) and (6) 

Article 14(1) and (2) 

Article 14(3)A and B 

Article 14(3) C 

Article 14(4) to (6) 

Article 15(1) 

Article 15(2) to (4) 

Article 16 

Article 17 

Article 17a 

Article 18 

Article 19 

Article 20 

EN 

Article 122,  

Article 99 and Article 100 

Article 122(1)(a) and (b) 

Article 140(3) 

- 

Articles 89, 92, 93, 94, 97, 100 and 101  

Article 95 

- 

Article 96 

- 

- 

Article 103 

- 

Article 256 

- 

- 

- 

- 

Article 103 

- 

- 

217 

   EN 

 
2. 

Directive 77/391/EEC 

Directive 77/391/EEC 

This Regulation 

Article 1 

Article 2(1) 

Article 2(2) 

Article 2(3) 

Article 2(4) 

Article 3(1) 

Article 3(2) 

Article 3(3) 

Article 3(4) 

Article 4 

Article 5 

Article 6 

Article 7 

Article 8 

Article 9 

Article 10 

Article 11 

Article 12 

Article 13 

Article 14 

Article 15 

- 

Article 30(1) 

Articles 31, 32 

Article 33 

Articles 36 and 41 

Article 30(1) 

Articles 31, 32 

Article 33 

Articles 36 and 41 

Articles 30(1), 31, 32, 33, 36 and 41 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

EN 

218 

   EN 

 
3. 

Directive 78/52/EEC 

Directive 78/52/EEC 

This Regulation 

Article 1 

Article 2 

Article 3(1) 

Article 3(2) 

Article 3(3) 

Article 3(4) 

Article 4 

Article 5 

Article 6(1) 

Article 6(2) 

Article 6(3) 

Article 7 

Article 8 

Article 9 

Article 10 

Article 11 

Article 12 

Article 13 

Article 14(1) 

Article 14(2) 

Article 14(3) 

Article 15 

Article 16 

Article 17 

Article 18 

- 

Article 4 (partially) 

Articles 30(1), 31, 34 and 35 

- 

- 

Articles 30(1) and 31 

Articles 30(1), 31 and 35 

Articles 16, 17, 18, 46 and 47 

Articles 73 to 75 

Articles 76 and 77 

Articles 78 and 79 

Articles 78 and 79 

Articles 78 and 79 

Articles 78 and 79 

Articles 78 and 79 

Articles 78 and 79 

Articles 78 and 79 

Articles 16, 17, 18, 46 and 47 

Articles 73 to 75 

Articles 76 and 77 

Articles 78 and 79 

Articles 78 and 79 

Articles 78 and 79 

Articles 78 and 79 

Articles 78 and 79 

EN 

219 

   EN 

Article 19 

Article 20 

Article 21 

Article 22 

Article 23 

Article 24 

Article 25 

Article 26 

Article 27 

Article 28 

Article 29 

Article 30 

Articles 78 and 79 

Articles 78 and 79 

- 

Articles 16, 17, 18, 46 and 47 

Articles 73 to 79 

Articles 78 and 79 

Articles 78 and 79 

Articles 78 and 79 

Article 121(1), 123(1)(b) 

- 

- 

- 

4. 

Directive 80/1095/EEC 

Directive 80/1095/EEC 

This Regulation 

Article 1 

Article 2 

Article 3 

Article 3a 

Article 4 

Article 4a 

Article 5 

Article 6 

Article 7 

Article 8 

Article 9 

EN 

Articles 30(1) and 36 

Article 4 (partially) 

Articles 30(1), 34 and 35 

Articles 30(1), 34 and 35 

Articles 31, 32 and 35 

Articles 31, 32 and 35 

- 

Article 30(1)(b), 30(3) and Article 31  

Articles 36, 39 and 40 

Articles 41and 42 

- 

220 

   EN 

 
Article 11 

Article 12 

Article 12a 

Article 13 

5. 

Directive 82/894/EEC 

Directive 82/894/EEC 

Article 1 

Article 2 

Article 3 

Article 4 

Article 5 

Article 6 

Article 7 

Article 8 

6. 

Directive 88/407/EEC 

Directive 88/407/EEC 

Article 1 

Article 2 

Article 3 

Article 4 

Article 5 

Article 6(1) 

Article 6(2) 

Article 6(3) and (4) 

EN 

- 

- 

- 

- 

- 

This Regulation 

Article 4 (partially) 

Articles 17, 19, 20 and 21 

Articles 17,18, 19, 20 and 21 

Article 21(b) and (c) 

- 

- 

- 

- 

This Regulation 

Article 4 (partially) 

Articles 157 and 158 

Article 158(b) and (c) 

Article 89, 92, 95 and 96  

Articles 159 and 160 

- 

- 

221 

   EN 

 
 
Article 8 

Article 9 

Article 10 

Article 11 

Article 12 

Article 15 

Article 16 

Article 17 

Article 18 

Article 20 

Article 21 

Article 22 

7. 

Directive 89/556/EEC 

Directive 89/556/EEC 

Article 1 

Article 2 

Article 3 

Article 5(1) 

Article 5(2) 

Article 5(2a) and (3) 

Article 6 

Article 7 

Article 8 

Article 9 

Article 10 

Articles 230(1)(a) and 231 

Articles 230(1)(b), 234 and 235 

Articles 230(1)(c), 231, 236 and 238 

Article 230(1)(d) and Articles 239, 240 

Article 230(2)  

Articles 246 to 251 

- 

- 

- 

- 

- 

- 

- 

This Regulation 

Article 4 (partially) 

Article 157, 158, 159 

Articles 89 and 92 

Article 96 

Article 92 

Article 159 and 160  

Articles 230(1)(a) and 231 

Articles 230(1)(b), 234 and 235 

Articles 230(1)(c), 236 and 238 

Articles 230(1)(d), 239, 240 

EN 

222 

   EN 

 
Article 11 

Article 14 

Article 15 

Article 16 

Article 17 

Article 18 

Article 19 

Article 20 

Article 21 

8. 

Directive 90/429/EEC 

Directive 90/429/EEC 

Article 1 

Article 2 

Article 3 

Article 4 

Article 5(1) 

Article 5(2) 

Article 6(1) 

Article 6(2) 

Article 7 

Article 8 

Article 9 

Article 10 

Article 11(1) 

Articles 230(2) and 249 to 251 

Articles 246 to 248 

- 

- 

- 

- 

- 

- 

- 

- 

This Regulation 

Article 4 (partially) 

Articles 157 and 158  

- 

Articles 89 and 92 

Article 96 

Articles 159 and 160 

-  

Articles 230(1)(a) and 231 

Articles 230(1)(b), 234 and 235 

Articles 230(1)(c), 236 and 238 

Article 230(1)(d), 239, 240 

Article 230(2)  

Article 11(2) and (3) 

EN 

- 

223 

   EN 

 
Article 12 

Article 13 

Article 14 

Article 15 

Article 16 

Article 17 

Article 18 

Article 19 

Article 20 

Article 21 

Article 22 

9. 

Directive 91/68/EEC 

Directive 91/68/EEC 

Article 1 

Article 2 

Article 239 

- 

- 

Articles 246 to 251 

- 

- 

- 

- 

- 

- 

- 

- 

This Regulation 

Articles 4 (partially), 150(3) and 220(3) 

Article 3(1)(2)(3) and (5) 

Articles 127 and 128 

Article 3(4) 

Article 4(1) 

Article 4(2) 

Article 4(3)  

Article 4a 

Article 4b(1) to (3) 

Article 4b(4) 

Article 4b(5) 

Article 4b(6) 

Article 136 

Articles 121(2)(b), 127 and 128 

Article 125 

Article 128 

Article 128 

Article 128 

Article 130 

Article 129 

Articles 121(1) and 122 

EN 

224 

   EN 

 
Article 4c(1) and (2) 

Article 128 

Article 4c(3) 

Article 5 

Article 6 

Article 7(1) to (3) 

Article 7(4) 

Article 8(1) to (3) 

Article 8(4) 

Article 8a(1) 

Article 8a(2) 

Article 8a(3) 

Article 8a(4) 

Article 8a(5)  

Article 8b(1) 

Article 8b(2) 

Article 8b(3) 

Article 8b(4) 

Article 8c(1) 

Article 8c(2) 

Article 8c(3) 

Articles 130 and 132 

Article 128 

Article 128 

Articles 30, 31 and 32  

- 

Articles 36, 39 and 40 

- 

Articles 89(1)(a), 92, 93 and 131 

Article 97, 100  

Articles 93, 94 and 96 

Article 95 

Article 92(1)(d) and (2)(d) 

Articles 82, 89(1)(a), 92, 93, 97, 100 and 131 

Articles 89, 92, 93 

Article 95 

- 

Articles 85 and 122 

Article 99 

Article 122(1)(a) 

Article 8c(4) and (5) 

- 

Article 9 

Article 10 

Article 11 

Article 12 

Article 14 

EN 

Articles,  140,  141,  142,  143,  144,  145,  146 
and 150 

- 

- 

Article 141(b) 

- 

225 

   EN 

Article 15 

Article 17 

Article 18 

10. 

Decision 91/666/EEC 

Decision 91/666/EEC 

Article 1 

Article 2 

Article 3 

Article 4 

Article 5 

Article 6 

Article 7 

Article 8 

Article 9 

Article 10 

Article 11 

Article 12 

11. 

Directive 92/35/EEC 

Directive 92/35/EEC 

Article 1 

Article 2 

Article 3 

Article 4 

Article 5 

- 

- 

- 

- 

This Regulation 

Article 4 (partially) 

Article 48 

Articles 48, 49 and 50 

Articles 48 and 50 

Articles 15 and 48(3)(b)  

Article 50 

- 

- 

- 

- 

- 

- 

This Regulation 

Article 4 (partially) 

Article 16 

Articles 53 to 57 and 59 

Articles 46 and 47 

EN 

226 

   EN 

 
 
Article 6 

Article 7 

Article 8 

Article 9 

Article 10 

Article 11 

Article 12 

Article 13 

Article 14 

Article 15 

Article 16 

Article 17 

Article 18 

Article 19 

Article 20 

Article 21 

Article 22 

12. 

Directive 92/65/EEC 

Directive 92/65/EEC 

Article 1 

Article 2 

Article 3 

Article 4 

Article 5 

Articles 60 to 69 

Article 57 

Article 64 

Articles 65, 66 and 67 

Articles 65, 66 and 67 

Article 68 

Article 71(1) 

Article 65(2) 

- 

- 

- 

Articles 43, 44 and 45 

- 

- 

- 

- 

- 

- 

This Regulation 

Article 4 (partially) 

- 

Articles  121,  123,  16,  17,  18,  30(2),  140  to 
143, 146 and 148 

Articles 133, 134, 140, 141  

EN 

227 

   EN 

 
Article 6(A) 

Article 6(B) 

Article 7(A) 

Article 7(B) 

Article 8 

Article 9 

Article 10(1) to (4) 

Article 10(5) to (7) 

Article 10a 

Article 11(1) 

Articles 121, 123, 127, 128, 134, 137, 140 to 
143  

- 

Articles 121, 123, 127, 128, 134, 137 and 140 
to 143 

- 

Articles 121, 123, 133 and 140 to 143 

Articles 121, 123, 133 and 140 to 143 

Articles 121, 123, 133, 140 to 143 

- 

- 

Article 155 

Article 11(2) and (3) 

Articles 155, 157 and 158, 140 to 143 

Article 11(4) 

Article 11(5) 

Article 12(1)  

Article 12(2) 

Article 12(3) 

Article 12(4) 

Article 12(5) 

Article 12(6) 

Article 13(1) 

Article 13(2) 

Article 14 

Article 15 

Article 16 

Article 17(1) 

Articles 92 and 96 

Article 162 

- 

Article 246 to 248 

Articles 82, 97, 100 

Articles 140 to 146 and 149 to 151 

- 

Article 256 

Articles 133, 140 to 146 and 148 

Articles 90, 92, 93 to 96  

Articles 30, 31 and 32 

Articles 36, 39, 40 and 41 

Articles 230(1) and 236 

Article 230(1)(a)(b) and (c)  

EN 

228 

   EN 

 
 
Article 17(2) 

Article 17(3) 

Article 231,  

Article 231, 234, 235 

Article 17(4) and (5) 

- 

Article 18 

Article 19 

Article 20 

Article 21 

Article 22 

Article 23 

Article 24 

Article 25 

Article 26 

Article 27 

Article 28 

Article 29 

Article 30 

13. 

Directive 92/66/EEC 

Directive 92/66/EEC 

Article 1 

Article 2 

Article 3 

Article 4 

Article 5 

Article 6 

Article 7 

Article 230(1)(d), 239 

Article 236 

Articles 230(2), 246 to 248  

Article 141, 142, 143, 160, 209 and 211  

- 

- 

Articles  230(1)(d),  239  and  241(1)(a)(v)  and 
(1)(c)(iv)  

-  

- 

- 

-  

-  

- 

- 

This Regulation 

Article 4 (partially) 

Article 16 

Articles 53 to 56, 57(1) and 59 

Articles 60 to 63 

Article 63  

Articles 57, 43(2)(d)  

EN 

229 

   EN 

 
Article 8 

Article 9(1) 

Article 9(2) to (7) 

Article 10 

Article 11 

Article 12 

Article 13 

Article 14 

Article 15 

Article 16 

Article 17 

Article 18 

Articles 55 and 56 

Article 64  

Articles 65 to 68 

Articles 65 and 67 

Articles 67(b), 68(1)(b) and (2)(a) 

Article 54 

Article 65(2) 

- 

- 

Articles 46 and 47 

Article 47 

Articles 65(e), 67 and 69 

Article 19(1) to (3) 

Articles 53 to 56 

Article 19(4)  

Article 19(5) 

Article 20 

Article 21 

Article 22 

Article 23 

Article 24 

Article 25 

Article 26 

Article 27 

Articles 57(1), 60 to 63 

Article 71(2) 

- 

Articles 43 and 44 

- 

- 

- 

-  

-  

- 

EN 

230 

   EN 

 
14. 

Directive 92/118/EEC 

Directive 92/118/EEC 

This Regulation 

Article 1 

Article 2 

Article 3 

Article 4(1) 

Article 4(2) 

Article 5 

Article 6 

Article 7(1) 

Article 7(2)  

Article 7(3)  

Article 7(4) 

Article 8 

Article 9 

Article 10 

Article 11 

Article 12 

Article 13 

Article 14 

Article 15 

Article 16 

Article 17 

Article 18 

Article 19 

Article 20 

EN 

- 

Article 4 (partially) 

Article 164, 223 and228(c)(v) 

Articles 164, 223 and 228(c)(v) 

- 

Articles 164 and 223 

Article 15(1)(b) and (2)(b) 

-  

Articles 246 to 248 

- 

Article 256 

- 

Articles 230 and 236 

Articles 230, 236, 239 and 241 

Article 241(1)(c)(ii) 

- 

Article 241(1)(c)(i) 

- 

-  

Article 241(1)(c)(v)  

- 

- 

-  

-  

231 

   EN 

 
15. 

Directive 92/119/EEC 

Directive 92/119/EEC 

This Regulation 

Article 1 

Article 2 

Article 3 

Article 4 

Article 5 

Article 6 

Article 7 

Article 8 

Article 9 

Article 10 

Article 11 

Article 12 

Article 13 

Article 14 

Article 15 

Article 16 

Article 17 

Article 18 

Article 19 

Article 20 

Article 21 

Article 22 

Article 23 

Article 24 

Article 25 

EN 

- 

Article 4 (partially) 

Article 16 

Articles 53 to 57 and 59 

Articles 60 to 63 

Article 70 and 71(2) 

Article 63  

Article 57 

Articles 62 and 63 

Article 64 

Articles 65 to 68 and 71(2) 

Articles 65 to 68 

Article 67(a) 

Article 65(2) 

- 

Articles 63(b), 67(b), 68(1)(b) and (2)(a) 

- 

- 

Articles 46, 47 and 69 

Articles 43, 44 and 45 

- 

- 

- 

- 

- 

232 

   EN 

Article 26 

Article 27 

Article 28 

- 

- 

- 

16. 

Decision 95/410/EEC 

Decision 95/410/EEC 

This Regulation 

Article 1 

Article 2 

Article 3 

Article 4 

Article 5 

Article 6 

17. 

Directive 2000/75/EC 

Directive 2000/75/EC 

Article 1 

Article 2 

Article 3 

Articles 127 to 129 

Article 128(1)(c)  

Articles 140, 142 and 143 

- 

- 

- 

- 

This Regulation 

Article 4 (partially) 

Article 16 

Article 4(1) and (2) 

Articles 54 and 55 

Article 4(3) 

Article 4(4) 

Article 4(5) 

Article 4(6) 

Article 5 

Article 6 

Article 7 

Article 53 

Article 56 

Article 70 

Article 59 

Articles 46 and 47 

Articles 60 to 64 

Article 57 

EN 

233 

   EN 

 
 
Article 8 

Article 9 

Article 10(1) 

Article 10(2) 

Article 11 

Article 12 

Article 13 

Article 14 

Article 15 

Article 16 

Article 17 

Article 18 

Article 19 

Article 20 

Article 21 

Article 22 

Article 23 

Articles 64,68 and 71(3) 

Articles 65 and 67 

Articles 64 and 67  

Articles 46 and 47 

- 

Articles 65 and 67 

Article 71(1) 

Article 65(2) 

- 

- 

- 

Articles 43, 44 and 45 

- 

- 

- 

- 

- 

18. 

Regulation (EC) No 1760/2000 

Regulation (EC) No 1760/2000 

This Regulation 

Article 1 

Article 2 

Article 3 

Article 4 

Article 5 

Article 6 

Article 102 

Article 4 (partially) 

Article 102(2) and 105 

Articles 106(a), 108, 114, 115 and 117 

Article 103(1)(a) 

Article 104, 106(b), 108, 114, 115 and 117 

EN 

234 

   EN 

 
Article 7 

Article 8 

Article 9 

Article 10(a) to (c) 

Article 10(d) and (e) 

Article 10(f) 

Article 97, 100, 101 and 106(b)(i) and (c) 

Article 105 

- 

Articles 114, 115, 117 

- 

Article 258 

Article 11 

Article 12 

Article 13 

Article 14 

Article 15 

Article 16 

Article 17 

Article 18 

Article 19 

Article 20 

Article 21 

Article 22 

Article 23 

Article 24 

Article 25 

19. 

Directive 2001/89/EC 

Directive 2001/89/EC 

Article 1 

Article 2 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

This Regulation 

Article 4 (partially) 

EN 

235 

   EN 

 
Article 3 

Article 4 

Article 5 

Article 6 

Article 7 

Article 8 

Article 9 

Article 10 

Article 11 

Article 12 

Article 13 

Article 14 

Article 15 

Article 16 

Article 17 

Article 18 

Article 19 

Article 20 

Article 21 

Article 22 

Article 23 

Article 24 

Article 25 

Article 26 

Article 27 

Article 28 

EN 

Articles 16, 17, 18 and 21 

Articles 53 to 57(1) and 59 

Articles 60 to 63 and 71(2) 

Articles 63 and 71 

Articles 62, 63 and 65(1)(b) 

Article 57 

Article 64 

Articles 65 to 68 

Articles 65 to 68 

Articles 65(1)(f), 67(b) and 68(1)(b) 

Articles 61(3), 63(d) and 68 

Articles 62 and 63 

Article 70 

Article 70 and Articles 30 to 35 

Articles 15, 54(2) and (3), 65(1)(b) and 67(c) 

Articles 15, 46 and 47 

Articles 65(1)(e), 67 and 69 

Article 70 

- 

Articles 43, 44 and 45 

Articles 43(2)(d) and 44 

- 

- 

- 

- 

- 

236 

   EN 

Article 29 

Article 30 

Article 31 

20. 

Directive 2002/60/EC 

Directive 2002/60/EC 

Article 1 

Article 2 

Article 3 

Article 4 

Article 5 

Article 6 

Article 7 

Article 8 

Article 9 

Article 10 

Article 11 

Article 12 

Article 13 

Article 14 

Article 15 

Article 16 

Article 17 

Article 18 

Article 19 

Article 20 

EN 

- 

- 

- 

- 

This Regulation 

Article 4 (partially) 

Articles 16, 17, 18 and 21 

Articles 53 to 56, 57(1) and 59 

Articles 60 to 63 and 71(2) 

Articles 63 and 71 

Articles 62 and 63 

Article 57 

Article 64 

Articles 65, 67 and 68 

Articles 65, 67 and 68 

Article 65(1)(f), 67(b) and 68(1)(b) 

Articles 61(3), 63(d) and 68 

Articles 62 and 63 

Article 70 

Article 70 and Articles 30 to 35 

Articles 61(f) and 63 

Articles 15, 54(2) and (3), 65(1)(b) and 67(c)  

Articles 15, 46 and 47  

- 

237 

   EN 

 
Article 21 

Article 22 

Article 23 

Article 24 

Article 25 

Article 26 

Article 27 

Article 28 

Article 29 

Article 30 

21. 

Directive 2002/99/EC 

Directive 2002/99/EC 

Article 1 

Article 2 

Article 3 

Article 4 

Article 5 

Article 6 

Article 7 

Article 8 

Article 9 

Article 10 

Article 11 

Article 12 

Article 13 

EN 

Articles 43, 44 and 45 

Articles 43(2)(d) and 44 

- 

- 

- 

- 

- 

- 

- 

- 

- 

This Regulation 

Article 4 (partially) 

Articles 164, 223 and 228(c)(v) 

Articles  65(1)(c),(d)(i),(g),(h),(i),  67,  164, 
223 and 229(1)(d) 

Articles 165, 166, 224 and 225 

- 

Articles 236 and 238 

Article 231, 232 and 233 

Articles 239 and 240 

- 

- 

- 

- 

238 

   EN 

 
Article 14 

Article 15 

Article 16 

22. 

Directive 2003/85/EC 

Directive 2003/85/EC 

Article 1 

Article 2 

Article 3 

Article 4 

Article 5 

Article 6 

Article 7 

Article 8 

Article 9 

Article 10 

Article 11 

Article 12 

Article 13 

Article 14 

Article 15 

Article 16 

Article 17 

Article 18 

Article 19 

Article 20 

- 

- 

- 

- 

This Regulation 

Article 4 (partially) 

Articles 16, 17, 18 and 21 

Articles 53 to 56 and 57(1) 

Article 55(1)(d),(e) and (2) 

Articles 55(1)(f)(i) and (2), and 56(b) 

Article 55(1)(f)(ii)  

Article 55(1)(f) and (2) 

Article 59 

Articles 60, 61, 63 

Articles 61(1)(f) 63(b), 65(1)(f) and 67(b) 

Article 65(1)(h),(i) and Article 67 

Article 57 

Articles 61 and 63 

Articles 61 and 63 

Articles 61, 62 and 63 

Article 71(2) and (3) 

Articles 61and 63  

Articles 62 and 63 

Article 71(2) and (3) 

EN 

239 

   EN 

 
Article 21 

Article 22 

Article 23 

Article 24 

Article 25 

Article 26 

Article 27 

Article 28 

Article 29 

Article 30 

Article 31 

Article 32 

Article 33 

Article 34 

Article 35 

Article 36 

Article 37 

Article 38 

Article 39 

Article 40 

Article 41 

Article 42 

Article 43 

Article 44 

Article 45 

Article 46 

Articles 64 

Articles 65 to 67 

Articles 65 to 67 

Articles 67 and 71(1) 

Article  65(1)(c),(d)(i),(g),  (h),  (i)  and  Article 
67 

Articles 65(1)(c),(d)(i),(g),(h),(i), 67 and 164  

Articles 65(1)(c),(d)(i),(g), (h), (i), 67, 164  

Article 65(1)(c),(d)(iii) and Article 67 

Article 65(1)(c),(d)(ii) and 67 

Article 65(1)(c),(d)(ii) and 67 

Article 65(1)(c),(d)(ii) and 67 

Articles 65 and 67 

Article 65(1)(c)(d)(ii) and 67 

Articles 67, 140(2), 159(1)(b), 165(1)(b) 

Article 71 

Article 68 

Articles 65 and 67 

Articles 65 and 67 

Articles 65(1)(c),(d)(i),(g), (h), (i), 67, 164 

Articles 65(1)(c),(d)(i),(g), (h), (i), 67, 164 

Article 65(1)(c),(d)(ii) and 67 

Articles 65 and 67 

Article 71 

Article 68 

Articles 64, 69 and 71 

Articles 65 and 67 

EN 

240 

   EN 

Article 47 

Article 48 

Article 49 

Article 50 

Article 51 

Article 52 

Article 53 

Article 54 

Article 55 

Article 56 

Article 57 

Article 58 

Article 59 

Article 60 

Article 61 

Article 62 

Article 63 

Article 64 

Article 65 

Article 66 

Article 67 

Article 68 

Article 69 

Article 70 

Article 71 

Article 72 

EN 

Article 65(1)(h) and 67 

Article 140 

Articles 15, 46 and 47 

Articles 46,47 and 69 

Articles 46, 47 and 69 

Articles 46 and 47 

Articles 46 and 47 

Articles 46, 47, 65, 67 and 69(3) 

Articles 46, 47, 65, 67, and 69(3) 

Articles 47, 68(1)(c) and 69(3) 

Articles 47, 68(1)(c) and 69(3) 

Article 65(1)(c) and 67 

Articles 36, 38, 39, 40 and 68 

Articles 36, 38, 39, 40 and 68 

Articles 36, 38, 39, 40 and 68 

Article 68 

Articles 140(2), 159 and 165 

Articles 69(3) and 128 

Article 15 

- 

- 

- 

- 

Article 15 

Articles 54(2) and (3), 58, 61(1)(g), 63(c) and 
65(1)(b), 67(c), 68(1)(c) and 2(b) 

Article 43 

241 

   EN 

Article 73 

Article 74 

Article 75 

Article 76 

Article 77 

Article 78 

Article 79 

Article 80 

Article 81 

Article 82 

Article 83 

Article 84 

Article 85 

Article 86 

Article 87 

Article 88 

Article 89 

Article 90 

Article 91 

Article 92 

Article 93 

Article 94 

Article 95 

EN 

Article 45 

Article 43(2)(d) 

Article 44 

Article 43(2)(d) and 44 

Article 44 

Article 43(2)(d) 

Article 52 

Article 48 

Articles 48(3) and 50 

Articles 48(3) and 50 

Article 49 

Articles 48(3) and 50 

Articles 70 and 71 

Article 256 

- 

Article 71(3) 

- 

- 

- 

- 

- 

- 

- 

242 

   EN 

 
23. 

Regulation (EC) No. 998/2003  

Regulation (EC) No. 998/2003 

This Regulation 

Article 1 

Article 2 

Article 3 

Article 4 

Article 5 

Article 6 

Article 7 

Article 8 

Article 9 

Article 10 

Article 11 

Article 12 

Article 13 

- 

- 

Article 4 (partially) 

Articles 112, 114(e) and 117 

Articles 152, 222 and 228 

- 

Articles 152(2) and (3) and 222(2) and (3) 

Article 241(1)(a)(ii) 

Article 241(1)(a)(ii) 

Article 231 

- 

- 

- 

Article 14 (1st and 2nd paragraph) 

Article 239 

Article 14 (3rd paragraph) 

Article 14 (4th paragraph) 

- 

Articles 236(1)(b) and 241(1)(a)(ii) 

Article 15 

Article 16 

Article 17 

Article 18 

Article 19 

Article 19a(1) 

Article 19a(2) 

Article 20 

EN 

- 

- 

Articles  152(2)  and  (3),  222(2)  and  (3),  228, 
and 241(1)(a)(ii) 

Articles 246 to 251 

Articles  4(2)(b),  152(2)  and  (3),  222(2)  and 
(3), 228, and 241(1)(a)(ii) 

Article 114(e) and 117 

Article 152(2) and (3) 

- 

243 

   EN 

Article 21 

Article 22 

Article 23 

Article 24 

Article 25 

- 

- 

- 

- 

- 

24. 

Regulation (EC) No 21/2004 

Regulation (EC) No 21/2004 

This Regulation 

Article 1 

Article 2 

Article 3(1) 

Article 3(2) 

Article 102 

Article 4 (partially) 

Article 102(2) 

Article 105 

Article 4(1) and (2) 

Articles 107(a), 114, 115 and 117 

Article 4(3)  

Article 4(4) to (7) 

Article 4(8) 

Article 4(9) 

Article 5 

Article 6 

Article 7 

Article 8(1) 

Article 8(2) 

Article 8(3) to (5) 

Article 9 

Article 10(1)(a) 

Article 10(1)(b) 

Articles 114(b) and 115(a) 

Article 114 

Article 105 

Article 114(b) 

Articles 97, 100, 101, 105 and 106(b) and (c) 

Articles  105(b),  107(b),  108,  114(c)(ii),  115 
and 117 

Article 96 

Article 103,  

Article 107(c), 

Article 103 

Articles 114(b) and 117 

- 

Article 256 

EN 

244 

   EN 

 
Article 10(1)(c) 

Article 10(2) 

Article 11 

Article 12(1) 

Article 12(2) 

Article 12(4) to (7) 

Article 13 

Article 14 

Article 15 

Article 16 

Article 17 

25. 

Directive 2004/68/EC 

Directive 2004/68/EC 

Article 1 

Article 2 

Article 3(1) 

Article 3(2) 

Article 4 

Article 5 

Article 6 

Article 7 

Article 8 

Article 9 

Article 10 

Article 11 

Article 258 

Article 117 

Article 105 

- 

Article 256 

- 

- 

- 

- 

- 

- 

- 

This Regulation 

Article 4 (partially) 

Article 230(1)(a) 

Article 233(1) 

Article 231(1)  

Articles 231(1),(3) and 232  

Articles 236 and 237 

Article 236(1)(a) and 2 and Article 237 

Articles 236, 239(4) and 241(1)(a) 

Articles 236(1) and 239 (4) 

Article 236(1) and 239(4) 

Articles 230(1)(d), 239 and 240 

EN 

245 

   EN 

 
Article 12 

Article 13 

Article 14 

Article 16 

Article 17 

Article 18 

Article 19 

Article 20 

Article 21 

26. 

Directive 2005/94/EC 

Directive 2005/94/EC 

Article 1 

Article 2 

Article 3 

Article 4 

Article 5 

Article 6 

Article 7 

Article 8 

Article 9 

Article 10 

Article 11 

Article 12 

Article 13 

Article 14 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

This Regulation 

Article 4 (partially) 

Article 9 

Articles 27 and 28 

Article 16, 17, 18 and 21 

Article 57 

Articles 53 to 56 and 57(1) 

Article 55(2)  

Article 59 

Articles 55(1)(e),(f) and 56 

Articles 61 and 63 

Article 63 

Articles 61 and 63 

Article 63(a) 

EN 

246 

   EN 

 
Article 15 

Article 16 

Article 17 

Article 18 

Article 19 

Article 20 

Article 21 

Article 22 

Article 23 

Article 24 

Article 25 

Article 26 

Article 27 

Article 28 

Article 29 

Article 30 

Article 31 

Article 32 

Article 33 

Article 34 

Article 35 

Article 36 

Article 37 

Article 38 

Article 39 

Article 40 

Articles 62 and 63(e) 

Article 64 

Articles 65 and 67 

Articles 65(1)(a) and (b) and 67 

Articles 65 and 67 

Article 65(1)(d)(ii) and 67 

Articles 65(1)(c) and (i) and 67 

Article 65(1)(c) and (i) and Article 67 

Articles 65(1)(c) and 67 

Articles 65(1)(c) and 67 

Articles 65(1)(c) and 67 

Articles 65(1)(c) and 67 

Articles 65(1)(d)(ii) and 67 

Articles 65(1)(f) and 67(b) 

Article 68 

Articles 65 and 67 

Article 68  

Articles 64, 65, 67 and 71(3) 

Articles 67 and 71(3) 

Articles 37, 65(1)(i), 67 and 71(3) 

Articles 54 and 61 

Articles 61 and 63 

Articles 61 and 63 

Articles 61, 63, 65 and 67 

Articles 61, 63 and 71(3) 

Articles 61,63 and 71(3) 

EN 

247 

   EN 

Article 41 

Article 42 

Article 43 

Article 44 

Article 45 

Article 46 

Article 47 

Article 48 

Article 49 

Article 50 

Article 51 

Article 52 

Article 53 

Article 54 

Article 55 

Article 56 

Article 57 

Article 58 

Article 59 

Article 60 

Article 61 

Article 62 

Article 63 

Article 64 

Article 65 

Article 66 

EN 

Articles 61,63 and 71(3) 

Articles 62 and 63 

Article 64 

Articles 65 and 67 

Article 68 

Article 64(4), 67 and 71(3) 

Article 61, 63 and 71 

Article 68(1)(b) and 2(a) 

Articles 61(3) and 68 

Articles 15, 54(2)(b), (c) and (3), 58(2), 63(5) 

- 

Articles 46 and 47 

Article 69 

Articles 46, 47, 65, 67 and 69 

Articles 46, 47, 65, 67 and 69 

Articles 46 and 47  

Article 47  

Articles 48 to 51 

Article 52 

- 

Article 256 

Articles 43 to 45 

- 

- 

- 

- 

248 

   EN 

Article 67 

Article 68 

Article 69 

27. 

Directive 2006/88/EC 

Directive 2006/88/EC 

Article 1 

Article 2 

Article 3 

Article 4(1)  

Article 4(2) 

Article 4(3) 

Article 4(4) 

Article 4(5) 

Article 5 

Article 6 

Article 7 

Article 8 

Article 9 

Article 10 

Article 11 

Article 12 

Article 13 

Article 14(1) and (2) 

Article 14(3) and (4) 

- 

- 

- 

- 

This Regulation 

Articles 2 and 3(2) 

Article 4 (partially) 

Articles 170, 171, 174 and 175 

Article 177 

Article 183(2) 

Articles 170, 171, 172 and 173 

- 

Article 179 

Articles 183, 184 

- 

Articles 185, 186, 187 and 188 

Article 179(1)(a)(i), (2) and (3) 

Articles 179 (1)(a)(ii), (2) and (3) 

Articles 190 and 204 

Article 190 

Articles 191 

Article 208 

Articles 219 and 220 

EN 

249 

   EN 

 
 
 
Article 15(1) and (2) 

Article 15(3) 

Article 15(4) 

Article 16 

Article 17 

Article 18 

Article 19 

Article 20 

Article 21 

Article 22 

Article 23 

Article 24 

Article 25 

Article 26 

Article 27 

Article 28 

Article 29 

Article 30 

Article 31 

Article 32 

Article 33 

Article 34 

Article 35 

Article 36 

Article 37 

Article 38 

Articles 195, 196 

Article 192 

Articles 195, 196 and 198 

Article 196 

Article 196 

Articles 200 and 201 

Articles 200 and 201 

Article 199 

Articles 202, 203 and 205 

Article 230(1)(a) 

Articles 231and 232 

Articles 230(1)(d) and 239 

Articles 236, 239 and 240 

Article 16 

Articles 17 and 18 

Articles 53 to 55 and 72 to 74 

Article 57 

Articles 59 and 77 

- 

Articles 60, 61, 62 and 64 

Articles 65 and 67 

Article 61(1)(b)and (c) and Article 63 

Article 61(3) and 63 

- 

Article 68 

Articles 76 and 78 

EN 

250 

   EN 

Article 39 

Article 40 

Article 41 

Article 42 

Article 43 

Article 44 

Article 45 

Article 46 

Article 47 

Article 48 

Article 49 

Article 50 

Article 51 

Article 52 

Article 53 

Article 54 

Article 55 

Article 56 

Article 57(a) 

Article 57(b) 

Article 57(c) 

Article 58 

Article 59 

Article 60 

Article 61 

Article 62 

EN 

Articles 78 and 79 

Article 80 

Article 246(1)(b) and (c) 

Article 71(3) 

Article 227 

Articles 26, 27, 30 and 31 

Article 32 

Article 34 

Articles 43 and 44 

Article 46 and 47 

Article 36 

Article 36 and 37 

Article 38 

Article 41 

Article 42 

- 

- 

- 

- 

Articles 54(2)(c) and (3), 58, 61(1)(h), 63(c), 
67(1)(b) and 67(c) 

- 

- 

Article 38, 183 (partially) 

Article 256 

- 

- 

251 

   EN 

 
Article 63 

Article 64 

Article 65 

Article 66 

Article 67 

28. 

Directive 2008/71/EC 

Directive 2008/71/EC 

Article 1 

Article 2 

Article 3(1) 

Article 3(2) 

Article 4(1) 

Article 4(2) 

Article 5(1) 

Article 5(2) 

Article 6(1) 

Article 6(2) 

Article 7 

Article 8 

Article 9 

Article 10 

Article 11 

Article 12 

Article 13 

EN 

- 

- 

- 

- 

- 

- 

This Regulation 

Article 4 (partially) 

Article 96 Article 115 

- 

Articles 97 and 115 

Article 110 

Article 110(a), 114(b) and 117 

Article 110(a) and 111 

Article 110(a), 115 and 117 

- 

Article 103(1)(b) and (2) 

Articles 110, 114(d) 

Article 256  

- 

- 

- 

- 

252 

   EN 

 
 
29. 

Directive 2009/156/EC 

Directive 2009/156/EEC 

This Regulation 

Article 1 

Article 2 

Article 3 

Article 4(1)  

Article 4(2) 

Article 4(3) 

Article 4(4) 

Article 4(5) 

Article 4(6) 

Article 5 

Article 6 

Article 7(1) 

Article 7(2) 

Article 7(3) 

Article 8 

Article 9 

Article 10 

Article 11 

- 

Article 4 (partially) 

Articles 123 and 136 

Articles 127 and 146(3) 

Articles 127 and 128 

Article 125 

Articles 109, 114 and 117 

Articles 123(1)(a), 127 and 128 

Articles 30 to 35  

Articles 127 and 128 

Articles 127, 128 and 141(b)  

Articles 123(2) and 130  

Articles 127, 128 and 129 

Article 127, 128 and 129 

Articles 109(1)(c), 114, 117 and Articles 140 
to 143 

Articles 246 to 248 (partially)  

- 

- 

Article 12(1),(2) and (3) 

Articles 230(1)(a) and 231 

Article 12(4) and (5) 

Article 236 

Article 13 

Article 14 

Article 15 

Article 16 

Articles 231 and 236 

Article 236 

Article 236 

Articles 236, 238 and 239 

EN 

253 

   EN 

Article 17 

Article 18 

Article 19 

Article 20 

Article 21 

Article 22 

Article 23 

Article 24 

30. 

Directive 2009/158/EC 

Directive 2009/158/EEC 

Article 1 

Article 2 

Article 3 

Article 4 

Article 5 

Article 6 

Article 7 

Article 8 

Article 9 

Article 10 

Article 11 

Article 12 

Article 13 

Article 14 

Article 236 

- 

Article 236 

- 

- 

- 

- 

- 

- 

This Regulation 

Article 4 (partially) 

- 

- 

Articles 123, 127, 128, 157 and 158 

Articles 121, 123 and 157  

Article 96  

Articles 157 and 158  

Articles 127 and 128 

Articles 127 and 128 

Articles 127 and 128 

Articles 127 and 128 

Article 128 

Article 128 

Article 15(1)(a) 

Articles 157 and 158 

EN 

254 

   EN 

 
Article 15(1)(b) to (d) 

Articles 127 and 128 

Article 15(2) 

Article 16 

Article 17 

Article 18 

Article 19 

Article 20 

Article 21 

Article 22 

Article 23 

Article 24 

Article 25 

Article 26 

Article 27 

Article 28 

Article 29 

Article 30 

Article 31 

Article 32 

Article 33 

Article 34 

Article 35 

Article 36 

Article 37 

Article 38 

EN 

Articles 30 to 35 

Articles 30 to 35 

Articles 36, 39 and 40 

Articles 121, 122, 123(1)(a) and (2), 129 and 
155(3) 

Article 128 

Articles 140 to 147 and Articles 159 and 160 

- 

- 

Articles 230(1)(a), 231 and 232 

Article 236 

Article 236 

Article 239 

- 

Articles 236, 237 and 238 

Article 236 and 241 

Article 236 

Articles 246 to 248 

- 

- 

- 

- 

- 

- 

- 

255 

   EN