EN    EN  
 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}  EN 2   EN EXPLANATORY MEMORANDUM  
1. JUSTIFICATION AND OBJECTIVE  
Animal health is a concern for all Europ ean citizens. This concern stems from the 
public health, food safety and food security aspects, wh ich are related to animal 
health but also from the economic costs that  animal disease outbreaks can trigger and 
the animal welfare considerations, includ ing the implications of disease control 
measures on animal welfare.  
At the same time, this proposal reflec ts the priorities of  Smart Regulation1 by aiming 
to simplify the existing legal framework wh ile reflecting stakeholders' expectations 
in reducing administrative burdens.  
And finally, it reflects Commi ssion 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 pi eces of secondary legislation, some of 
them adopted as early as 1964.  
The Commission launched an external evalua tion in 2004 to thor oughly review the 
outcomes of EU action of animal health, l eading to a new Animal Health Strategy in 
2007. A combination of circumstances made it imperative to re-evaluate our policy:  
 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. Diseas es which were unknown a decade ago 
have appeared, while others, such as f oot and mouth diseas e, 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, technology and our ins titutional framework have evolved 
substantially. 
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 Co mmunity Animal Health Policy (CAHP) 
                                                 
1 COM(2010) 543 final "Smart Regulation in the European Union". 
2 COM(2010) 2020 "Europe 2020 - A strategy for smart, sustainable and inclusive growth". EN 3   EN – The lack of an overall strategy 
– An insufficient focus on disease preventi on, 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 problem s 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. Th e general objectives as outlined in the 
Strategy are:  
 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 preven ting/reducing the incidence of animal 
diseases, and in this way to support farming and the rural economy; 
 to improve economic growth/cohesion/competitiveness assuring free 
circulation of goods and propor tionate animal movements; 
 to promote farming practices and animal welfare which prevent animal health 
related threats and minimise envir onmental impacts in support of the EU 
Sustainable Development Strategy.  
The specific objectives of this Animal Health Law are:  to establish a single, simplified, transparent and clear regulatory framework 
that sets out systematically the objectiv es, 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 prin ciples allowing a simplified legal 
framework in order to be prepared for th e 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 horizonta l principles of the legislation in the 
field of animal health, animal welfar e and food safety policies as well as 
broader EU policies on climate change, common agricultural policy and sustainability; 
 to reduce the impact of animal diseas es on animal and public health, animal 
welfare, economy and society as fa r as possible by enhancing disease EN 4   EN awareness, preparedness, surveillan ce and emergency response systems at 
national and EU level;  
 to ensure the smooth functioning of the internal market of animals and animal 
products, with a high level of  protection of animal hea lth and public health and 
supporting the objectives of Europe 2020. 
The operational objectives of this Animal Health Law are:   to integrate the new prevention-driven and incentive-oriented approach into the 
core of animal health policy; 
 to provide for a clear and balanced di stribution of roles and responsibilities 
between competent authorities, EU in stitutions, 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 prep aredness and early response to animal 
diseases and zoonoses, including us e of vaccines as appropriate; 
 to introduce simplified procedures, wher ever possible for technical and other 
reasons, taking into account the specificity of small farmers and micro businesses and releasing unjustified admini strative burdens and costs, wherever 
possible; 
 to ensure that the new legal framew ork provides enough flexibility to adapt 
smoothly to future scientific and technological developments; 
 to reduce the risk of tr ade 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 he alth 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 b ecame 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.  EN 5   EN – Article 114 provides the legal basis for th e 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, includi ng those related to animal health. 
Veterinary measures directly aimed at  protecting public health were also 
adopted under the co-decision procedur e as a result of this article.".  
Consistency with other Union policies  
This set of animal health legislation in teracts with the legal framework on animal 
welfare, food safety, public health, animal  nutrition, veterinary medicinal products, 
environmental protection, official contro ls, 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 re views relating to animal health, health of 
plants, quality of plant reproduc tive material and official co ntrols of plants, animals, 
food and feed.  
The revision of the official controls regulation enables offi cial controls to be more 
consistently applied for the purposes of pr otection of animal health and links more 
coherently with animal health regulation.  
3. SUBSIDIARITY AND PROPORTIONALITY  
Subsidiarity  
Good animal health generates not only pr ivate 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, veterinari ans and veterinary-
related industries. It has played a key role in the establishment of the single market, facilitating intra-EU trade in animals a nd animal products (meat, milk, etc.) by 
setting up harmonised animal health condi tions and promoting the success of the 
CAP.  
The benefits of harmonised rules for the prevention, notific ation, control and 
eradication of animal diseases at EU level have been demonstrated during animal disease outbreaks in recent times. The res ponse to these crises showed the EU's 
capability to react quickly, limiting the sp read of diseases and minimising their 
impacts. This was largely due to the ha rmonised 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 potentia l. In light of these different elements, 
EU action is justified, as it is clear that MS cannot achie ve this satisfactorily acting EN 6   EN alone and that the EU would achieve a c onsistent approach more effectively and 
efficiently. 
Proportionality   
The Animal Health Law establishes a gene ral framework for th e prevention, control 
and eradication of animal diseases. This framework is built on outcome-based rules, 
avoiding over-prescriptiveness, and leavi ng room for MS to regulate or set more 
detailed legislation when necessary, so provi ding for the flexibility to adapt the rules 
to national, regional or local circumstances . On the other hand, ru les on trade must 
necessarily have a certain level of detail a nd precision to reduce the risk of different 
implementation practices by operators and competent authorities and subsequent 
distortion of competition and possible reducti on in the coherence of the approach to 
tackling disease. Therefore the Animal Hea lth Law tries to achieve the balance of 
proportional but necessary action.  
4. CONSULTATIONS WITH INTER ESTED PARTIES AND IMPACT 
ASSESSMENTS  
Consultation process  
This Animal Health Law is the result of a long series of considered analyses.  
In 2004, the Commission launched an i ndependent 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 fu rther 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 result
4. 
The AHS provides for the adoption of a "s ingle regulatory framework for animal 
health with a greater focus on incentives th an penalties, consis tent 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 Communicati on on the new Strategy, the European 
Parliament
5, the Council6 and the European Economic and Social Committee7 
welcomed this initiative. Subsequently, th e 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 http://ec.europa.eu/food/animal/diseases/strategy/cahpeval_en.htm 
4 http://ec.europa.eu/food/animal/d iseases/strategy/index_en.htm 
5 EP Resolution 2007/2260(INI). 
6 Doc.15481/07 ADD 1. 
7 NAT/376 – EU Animal Health Strategy. 
8 COM (2008) 545 final, http://ec.europa.eu/fo od/animal/diseases/strategy/documents_en.htm EN 7   EN 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 cr ucial role in the discussion. In addition, 
economic and social stakeholders such as Eu ropean associations w ith an interest in 
animal health and welfare and the interest ed public have been consulted on a number 
of occasions in accordance with the Co mmission’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 he alth measures for terrestrial and aquatic 
animals.  
Part I also provides for the prioritisation and lis ting of diseases wh ich are likely to 
have a significant impact. For the first time, this will enable Un ion resources to be 
systematically prioritised on a scientific and evidential basis.  
The responsibilities of all th e 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, ope rators and animal professionals are now 
required to acquire a basic knowledge of animal health and related matters.  
Part II: Notification, Surveillance, Er adication 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 synergie s between surveillance undertaken by the 
different actors in the field to ensure th e 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 pres ent, can now be used more widely. This 
introduces more flexibility into disease control measures, introducing the possibility 
of continuing movements and trade under cer tain circumstances, considered from a 
risk-based perspective.  
Part III: Disease Prepare dness, Awareness and Control
 
Part III continues to require MSs to dr aw up contingency plans for dealing with 
certain diseases, and to practise their implementation.  
The regulatory framework for vaccination is now explicitly and c oherently provided 
for.  
The rules for the use of antigen, vacc ine and reagent banks are laid down.  
Rules on control measures to be taken in  the case of suspici on of or confirmed 
disease outbreaks of certain diseases are la id down, with little change to the existing 
system, which is considered to work well.  EN 8   EN Part IV: Requirements Concerning Regi stration, Approval, Traceability and 
Movements  
Part IV is split into three titles, with distin ct rules for terrestrial, aquatic, and other 
animals. It is necessary to consider th em 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 th e 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 requiremen ts for third countries sending animals, 
germinal products, products of animal orig in 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 pract ical changes are envisaged from existing 
legislation, which is consid ered to function well.  
Part VI: Emergency Measures  
Emergency measures are a cruc ial part of disease manage ment. 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 consider ed 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 alrea dy included in the 
financial statement of the common financia l framework for food ch ain, animal health 
and welfare, and relating to plant he alth and plant reproductive material. EN 9   EN 2013/0136 (COD) 
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on Animal Health 
THE EUROPEAN PARLIAMENT AND THE CO UNCIL 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 Eu ropean Economic and Social Committee
9,  
Having regard to the opinion of  the Committee of the Regions10,  
Acting in accordance with the or dinary legislative procedure, 
Whereas: (1) The impact of transmissible animal dis eases and the measures necessary to control 
these diseases can be devastating for indi vidual animals, animal populations, animal 
keepers and the economy.  
(2) 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.  
(3) In addition, adverse interactive effects can be observed with re gard to biodiversity, 
climate change and other environmental as pects. Climate change may influence the 
emergence of new diseases, the prevalence  of existing diseases and the geographic 
distribution of disease agents and vector s, including those affecting wildlife. 
(4) In order to ensure high standards of animal  and public health in the Union, the rational 
development of the agriculture and aquacult ure sectors and to in crease 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 OJ C , , p. . 
10 OJ C , , p. . EN 10   EN (5) 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 a nd products, disease eradication, veterinary 
controls, notification of  diseases and financial support in  relation to different animal 
species, but an overarching legal framewor k, providing harmonised principles across 
the sector is missing.  
(6) The Animal Health Strategy for the Un ion (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 Regions
11. 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 propos es the adoption of a “singl e and simplified regulatory 
framework for animal health ” seeking convergence to inte rnational standards while 
ensuring a firm commitment to hi gh standards of animal health. 
(7) The aim of this Regulation is to implem ent the commitments and visions provided for 
in that Animal Health St rategy, including the "One h ealth" principle, and to 
consolidate the legal framework for a co mmon Union animal health policy through a 
single, simplified, and flexible regul atory framework for animal health. 
(8) Animals may suffer from a broad range of infectious or non-infectious diseases. Many 
diseases can be treated, have an impact onl y 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 publ ic health with effects felt on a population 
level. The animal health rules laid down in this Regulation shoul d 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 rega rds matters within its competence, of the 
agreements reached in the Uruguay Round multilateral negotiations (1986-1994)12 
approved on behalf of the then European Co mmunity, with regard to that portion of 
those matters which falls within its comp etence the Agreement establishing the World 
Trade Organization (WTO), and also the Agre ements 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 requi red to be used as a basis.  However, the members have 
the right to set their own relevant standard s provided that such standards are based on 
scientific evidence.  
                                                
 
11 COM (2007) 539 final. 
12 OJ L 336, 23.12.1994, p. 1. EN 11   EN (11) As regards animal health the SPS Agreem ent 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 significan t animal or public health risk exists but 
scientific uncertainty pers ists, Article 5(7) of the SPS Agreement which has been 
interpreted for the Union in the Communica tion from the Commission of 2 February 
2000 on the precautionary principle13 allows a Member of th at agreement to adopt 
provisional measures on the basis of av ailable pertinent information. In such 
circumstances, the WTO Member is requi red 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 wh ich the measures unde r this Regulation are 
taken, should be based on the available scie ntific evidence and undertaken in an 
independent, objective and transparent manne r. 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 safety
14. 
(14) Regulation (EC) No 1069/2009 of the Eu ropean Parliament and the Council of 
21 October 2009 laying down health rules as  regards animal by-products and derived 
products not intended for human consump tion 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 safe ty of the food and feed chain. In order to avoid any overlap 
of Union legislation, this Regulation s hould therefore only apply to animal by-
products and derived products where specifi c rules are not laid down in Regulation 
(EC) No 1069/2009, and where an animal h ealth risk is involved. For instance, 
Regulation (EC) No 1069/2009 does not regulate how to handle animal by-products 
and derived products in the c ontext of disease c ontrol measures, and so these issues 
are duly covered by this Regulation.  
(15) In addition, specific rules on transm issible animal diseases including those 
transmissible to humans ("zoonoses") are al ready 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 eradic ation 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 zoonose s 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 
                                                 
13 COM(2000) 1 final. 
14 OJ L 31, 1.2.2002, p. 1. 
15 OJ L 300, 14.11.2009, p. 1. 
16 OJ L 147, 31.5.2001, p. 1. 
17 OJ L 325, 12.12.2003, p. 31.  EN 12   EN the Council of 17 November 2003 on the cont rol of salmonella and other specified 
food-borne zoonotic agents18, and specific rules on communi cable 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 ep idemiological surveillance and control 
of communicable diseases in the Community19. Those acts should remain in force 
following the adoption of this Regulation. A ccordingly, in order to avoid any overlap 
of Union legislation, this Re gulation should only apply to zo onoses to the extent that 
specific rules are not al ready laid down in t hose other Union acts. 
(16) Diseases occurring  in wild animal popula tions may have a detrim ental effect on the 
agriculture and aquaculture sectors, on public health, the environment and 
biodiversity. It is therefor e appropriate that the scope of this Regulation should, in 
such cases, cover wild animals, both as poten tial victims of those di seases 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 th e semen, ova and embryos used in artificial 
insemination, ovum donation or embryo tran sfer. 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. Therefor e, effective animal health ru les need to cover all paths 
of infection and mate rial involved therein. 
(18) Animal diseases may have detrimental eff ects 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 measur es provided for in this Regulation also 
take account of biodiversity and thus this  Regulation should cove r animal species and 
disease agents, including those defined as inva sive 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 an imals. Council Direct ive 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 animals
20 lays 
down specific rules for aquatic animals. Yet in most cases, the main principles for 
good animal health governan ce are applicable to both groups of animal species. 
Accordingly, the scope of this Regulation should cover both terr estrial 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 Re gulation 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 OJ L 325, 12.12.2003, p. 1. 
19 OJ L 268, 3.10.1998, p. 1. 
20 OJ L 328, 24.11.2006, p 14. EN 13   EN (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 anim als, semen, ova and em bryos not subject to 
animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC
21 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 a quatic or terrestrial animals as defined in 
this Regulation. Usually, such species do not  represent a significan t 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 animal s, including ornamental aqua tic animals in households and 
non-commercial ornamental aqua ria, both indoors and outdoor s, 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 concer ning registration, record ke eping and movements within 
the Union apply to such animals, as this would represent an unj ustified administrative 
burden and cost. Registration and record k eeping requirements s hould therefore not 
apply to pet keepers. In addition, specific rules shou ld be laid down for non-
commercial movements of pet animals within the Union. 
(22) Some defined groups of animals, for whic h special animal health  rules exis t 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 futu re due to reasons of changed taxonomy, 
scientific development or technical updates ju stified by science. Similarly, the list of 
species of pet animals may need to be adju sted 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 Trea ty 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 prev ented 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 a nd control transmissible animal diseases 
may have important economic consequences fo r the relevant sector s and disrupt trade. 
It is therefore essential that such measur es 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 contro l 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. EN 14   EN and its consequences. The preventive and control rules applying to each of them 
should therefore be disease specific. 
(25) For transmissible animal diseases a di sease condition is usua lly associated with 
clinical or pathological manifestation of th e infection. However, for the purpose of this 
Regulation, which aims to control the spr ead of and eradicate certain transmissible 
animal diseases, the disease definition shou ld be wider in orde r 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 biodivers ity 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 ar e not subject to measures laid down at Union 
level, but which are of some economic impor tance 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 contro l such diseases, for instance through self-
regulatory measures or the deve lopment of codes of practice. 
(28) In contrast to the transm issible animal diseases descri bed in recitals 26 and 27, highly 
transmissible animal diseases may easily sp read 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 Comm unication from the Commission to  the European Parliament 
and the Council – Action plan against th e 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 pr eviously responsive is increasing. This 
resistance complicates the treatment of inf ectious diseases in humans and animals. As 
a result, microorganisms that have develope d resistance to antimicrobials should be 
treated as if they were transmissible dis eases, 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 dis eases. Furthermore, diseases and species 
that are important today may be marginalised in the future. Therefore the scope of this 
Regulation should be broad a nd the rules laid down shoul d be focused on diseases 
with high public relevance. The OIE ha s, with the support of the European 
Commission, developed a system of diseas e prioritisation a nd categoris ation, by 
producing a study on the "Listing and catego risation 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 COM (2011) 748. 
23 http://www.oie.int/en/support-to-oie-members/glo bal-studies/categorisation-of-animal-diseases/ EN 15   EN (31) In order to ensu re uniform conditions for the impl ementation 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 shoul d be conferred on the Commission.  
(32) Emerging diseases with the potential to cau se serious public or animal health risks and 
impacts on health, the economy or the en vironment may appear in the future. 
Following the assessment of such diseases and after adopting temporary emergency measures, when relevant, a quick reaction and in sertion of such diseases in the list of 
listed diseases may be necessary. Therefore th e 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 manageme nt approaches. Some highly 
contagious diseases which are currently not present in the Union require stringent measures to immediately eradicate them as s oon as they occur. For other diseases that 
might already be present in parts of the Un ion, 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 othe r instances it might be  appropriate only to 
implement surveillance of the disease's di stribution, 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 th at all relevant aspects are considered when 
determining which transmissible animal dis eases 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 li sted diseases to en sure coherence and 
consistency. In order to ensu re that technical and scientif ic progress and developments 
of relevant international standards are take n 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 animal s 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 Re gulation, 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 im pact of a listed disease, its distribution, 
prevalence and incidence in the Union and th e availability of disease prevention and 
control measures in respect of that liste d disease, a different category of specific 
disease prevention and control rules provi ded for in this Regulation should apply 
coherently and consistently to each listed disease.  
(37) In order to ensu re uniform conditions for the impl ementation 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 16   EN to listed diseases at Union level. Thus  implementing powers to lay down which listed 
diseases are to be subject to which rule s, should be conferred on the Commission.  
(38) Operators, animal profe ssionals 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 th erefore hold primary responsibility for carrying out 
measures for the prevention and control of the spread of diseas es among animals and 
products under their responsibility.  
(39) Biosecurity is one of the key prevention to ols at the disposal of operators, and others 
working with animals to prevent the in troduction, development and spread of 
transmissible animal diseases to, from and within an animal population. The role of 
biosecurity is also recognised in the Im pact 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 i nvolved and that they take account of the 
local circumstances and techni cal developments, the power to  adopt acts in accordance 
with Article 290 of the Treaty on the Func tioning 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 hyg iene or food and feed areas, 
insecticides, repellents or rodenticides play an important role in biosecurity strategies, both at farm level as well as during anim al transport. They should therefore be 
considered a part of biosecurity.  
(41) Knowledge of animal hea lth, including of disease symptoms , consequences of diseases 
and possible means of prevention includi ng biosecurity, treatment and control is a 
prerequisite for efficient animal health ma nagement and essential in ensuring the early 
detection of animal diseases. Operators and other animal professionals should 
therefore acquire such knowle dge as appropriate. That know ledge may be acquired by 
different means, for example formal edu cation, 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 or ganisations may be va luable contributors. 
Those alternative means of acquiring su ch knowledge should also be recognised by 
this Regulation. 
(42) Veterinarians and aquatic an imal health professionals play a crucial role in all aspects 
of animal health management, and ge neral rules concerni ng 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 necessa ry, inter alia, to 
diagnose diseases and treat animals. In addi tion, in some Member St ates 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 traditionall y 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 responsib ilities and obligations as veterinarians EN 17   EN 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 an imal 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 respec t to their qualific ation and training. 
(45) Member States and in part icular the competent authority thereof responsible for animal 
health are amongst the key actor s in the prevention and contro l of transmissible animal 
diseases. The competent authority for animal health plays an important role in relation to surveillance, eradication, disease cont rol measures, contingency planning, raising 
disease awareness, and in th e facilitation of animal move ments and in international 
trade by the issuing of animal health certific ates. To be able to perform their duties 
under this Regulation, Member States depend on having access to adequate financial, 
infrastructural and personnel resources throughout their territories, including 
laboratory capacity and scientific  and other relevant know-how.  
(46) The competent authority cannot always perf orm all the activities required to be carried 
out by it under this Regulation due to th e 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 en sure 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 accordan ce 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 t hose activities to veterinarians and their 
appropriate training. 
(47) Optimal animal health management can only be achieved in cooperation with animal 
keepers, operators, other stak eholders and trading partners. To secure their support it is 
necessary to organise decision making proce dures and the applica tion of the measures 
provided for in this Regulation in a clea r and transparent manner. Therefore the 
competent authority should take appropria te 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 fr om laboratories, institute s and other facilities 
handling diseases agents it is vital that th ey take appropriate biosecurity, biosafety and 
bio-containment measures. This Regulatio n 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 a pply to any legal or natural 
person, who is involved in such an activity. In order to ensure that sa fety 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 measur es in those laboratories, institutes and 
facilities and for movement s of diseases agents. 
(49) Early detection and a clear chain of di sease notification and re porting are crucial for 
effective disease control. In order to ach ieve an efficient a nd quick response any EN 18   EN suspicion or confirmation of an outbreak of certain listed diseases should be 
immediately notified to the competent auth ority. Those notificatio n obligations should 
be applicable to any natural and legal person in order to ensure that no disease outbreaks remain unnoticed. 
(50) Veterinarians are key acto rs in the investigation of di seases and a ke y link between 
operators and the competent authority. Therefore, they should be notified by the 
operator in cases of abnor mal mortalities, other se rious disease problems or 
significantly decreased production rate s with an undetermined cause.  
(51) In order to ensure the effective and e fficient notification and to clarify different 
circumstances related to abnormal mortalitie s and other serious diseases signs, the 
power to adopt acts in accordance with Ar ticle 290 of the Treaty on the Functioning of 
the European Union should be delegated to the Commission in resp ect of criteria to 
determine when relevant circumstances fo r the notification occur and the rules for 
further investigation, wh ere this is relevant. 
(52) For certain listed diseases it is vital th at 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 cond itions for the implementation of such Union 
notification, implementi ng 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 co ntrol measures. This reporting requirement 
may also apply to diseases which are subject to Union notification but where 
additional information is needed for th e implementation of effective disease 
prevention and control measures. In order to  ensure that the correct information and 
data, which are necessary to prevent the spr ead 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 concer ning the matters to be reported. 
(54) A key purpose of disease no tification and reporting is to generate reliable, transparent 
and accessible epidemiological data. A computerised information system for the effective collection and management of su rveillance 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 dise ase notification and 
reporting within the Union and at internatio nal level into one process (that is the 
WAHIS/WAHID database of the OIE). Consis tency with the excha nge of information 
in accordance with Directive 2003/99/EC
24 should also be ensured.  
(55) In order to ensure un iform conditions for the implementation of the Union disease 
notification and repo rting rules, implementing power s 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.  EN 19   EN Union reporting rules provided for in this Regulation and to esta blish the necessary 
procedures, formats, data and informati on exchanges regarding disease notification 
and reporting. 
(56) Surveillance is a key element of diseas e control policy. It shoul d provide for the early 
detection of transmissible an imal diseases and efficient notification, thereby enabling 
the sector and the competent authority to implement, where feasible, timely disease 
prevention and control measures, and the er adication of a disease. Furthermore, it 
should supply information on the animal hea lth status of each Member State and the 
Union, thereby substantiating disease freed om and facilitating trade with third 
countries. 
(57) Operators observe their animals on a regular basis and are best positioned to detect 
abnormal mortalities or othe r serious disease symptoms. Operators are therefore the 
cornerstone of any surveillance and essent ial for the surveillance undertaken by the 
competent authority.  
(58) To ensure close collaboration and exch ange of information between operators and 
veterinarians or aquatic animal health prof essionals and to supplement the surveillance 
undertaken by operators, establishments s hould, as appropriate for the type of 
production and other relevant factors, be subj ect 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 author ity has in place a system of surveillance for the 
listed diseases which are subject to surveilla nce. This should also apply to emerging 
diseases, where the potential health risks of that disease should be assessed and 
epidemiological data collected for that assessm ent. 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 th e surveillance, the 
animal health status in the region concer ned and any additional  surveillance conducted 
by operators.  
(61) In some cases, and depending on the epidem iological profile of a disease and relevant 
risk factors, a structured surveillance program me may need to be put in place. In that 
case it is appropriate that Member States de velop 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 criteri a for official confirmation of outbreaks 
and the case definitions of those dis eases and requirements for surveillance 
programmes in relation to their contents, in formation to be incl uded 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 EN 20   EN submitted to the Commission and other Member  States for information. Furthermore, 
the Member State implementing the surv eillance programme should also submit 
regular reports on the results of that su rveillance programme to the Commission. In 
order to ensure uniform conditions fo r the implementation of surveillance 
programmes, implementing powers shoul d 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. 
(63) Member States that are not  free or are not known to be fr ee from listed diseases which 
are subject to eradication measures as provided for in this Regulation, should be 
required to establish compulsory eradicati on programmes to eradicate those diseases 
where the eradication is compul sory in the Union, or have the possibility to establish 
voluntary eradication programmes, to eradicat e 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 compulso ry or voluntary er adication programmes. In order to 
ensure effective disease eradi cation, the power to adopt acts  in accordance with Article 
290 of the Treaty on the Functioni ng of the European Union should be delegated to the 
Commission in respect of the objectives of disease control strategies, disease control 
measures under the compulsory or voluntary eradication programmes and 
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 d eclaring the whole of 
their territories, zones or compartments ther eof free of one or more of listed diseases, 
which are subject to rules on compulsory or voluntary er adication 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-fr ee status, should be established for that 
purpose. In order to ensure uniform c onditions 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 C odes). In Union legislation 
adopted prior to this Regulation, that concep t is only recognised for particular animal 
species and diseases, specified in speci fic Union legislation, namely for avian 
influenza and aquatic animal diseases. This Regulation should esta blish the possibility 
of using the compartment system for other an imal 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 Functioni ng of the European Union should be delegated to the 
Commission. EN 21   EN (67) Member States should make their dis ease-free territory, z ones and compartments 
thereof publicly known for the purpose of in forming trading partners and facilitating 
trade.  
(68) In order to lay down the detailed conditi ons 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 restor ation of disease-free status. 
(69) In order to ensure uniform conditions fo r 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 s ubmission of applications and information 
exchange. 
(70) The presence of an enti rely non-immune population of anim als, susceptible to certain 
listed diseases, requires permanent disease awareness and preparedness. Contingency 
plans have proved to be a crucial tool for th e successful control of disease emergencies 
in the past. In order to ensure this effectiv e 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 de legated to the Commission in  respect of the detailed 
requirements and conditions for contingency plans. 
(71) Past animal health crises have shown th e benefits of having specific, detailed and rapid 
management procedures for disease emerge ncies. Those organisational procedures 
should ensure a rapid and effective response and improve coordination of efforts of all 
involved parties, and in particular the co mpetent authorities an d the stakeholders. 
(72) To ensure the applicability of continge ncy 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 competen t 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 implemen tation of those plans and exercises. 
(74) Veterinary medicinal products such as vaccines, hyper immune sera and antimicrobials 
play an important role in the prevention a nd 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 tr ansmissible animal dis eases require prohibition 
or restriction of the use of certain veteri nary medicinal products, as their use would 
hamper the effectiveness of those strategies. For example, hyper immune sera or antimicrobial agents may mask the expressi on of a disease, make the detection of a EN 22   EN disease agent impossible or render a swift a nd differential diagnosis  difficult and thus 
endanger the correct de tection of disease. 
(76) However, those control st rategies may substantially va ry between different listed 
diseases. Thus this Regulation should prov ide for rules on the use of veterinary 
medicinal products for the prevention an d 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 antimi crobials. In order to ensure a flexible 
approach and to address the specificities of di fferent listed diseases and the availability 
of the effective treatm ents, the power to adopt acts in  accordance with Article 290 of 
the Treaty on the Functioning of the Europe an Union should be delegated to the 
Commission in respect of the restrictions, prohibitions or  obligations to use certain 
veterinary medicinal products in the fram ework of the control of certain listed 
diseases. In the case of ur gency and in order to addres s 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 po ssible for the Union and the 
Member States to establish reserves of an tigens, 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 en abling 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 sta ndards and requirements  for the operation of 
those. However, this Regulation should not provide for the rules on the financing of 
the disease preventive and contro l 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 effec tive distribution in 
emergencies.  
(80) For reasons of security in  relation to bio-terrorism and ag ro-terrorism, certain detailed 
information concerning the Union antige n, vaccine and diagnostic reagent banks 
should be treated as classified informa tion 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, im plementing 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 whic h diseases, and detailed rules on the supply, 
quantities, storage, delivery, procedural  and technical requirements for vaccines, 
antigens and diagnostic reagents and the fr equency and content of submissions of 
information to the Commission. 
                                                
 
25 Doc SANCO/7070/2010. EN 23   EN (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 suspic ion or confirmation of highly contagious 
diseases.  
(84) The competent authority should be responsible  for initiating the fi rst 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 pl ace 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 confir med the competent authority should take the 
necessary disease control measures, if necessary including the establishment of 
restricted zones, to eradicate and preven t 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 rule s should therefore be laid down for disease 
control and eradication measures in wild animals where needed.  
(88) For listed diseases, which are not hi ghly contagious, and which are subject to 
compulsory eradication, the disease cont rol measures should be implemented to 
prevent the spread of those listed diseases, in particul ar 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 diseas es. Member States that have a voluntary 
eradication programme in place, should also  implement such disease control measures. 
However, the level and intensity of diseas e control measures s hould be proportionate 
and take into account the characteristics  of the listed disease in question, its 
distribution and its significance for the Memb er State concerned by it and the Union as 
a whole.  
(89) In order to ensure the e ffective application of the dise ase control measures provided 
for in this Regulation by operators, pet ke epers and the competent authorities and 
taking into account the specificities of the di sease 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 th e 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 basi s 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 c onferred on the Commission concerning the 
laying down of special disease control measures for a limited period of time. EN 24   EN (91) The registration of certain transporters and establishments keeping terrestrial animals 
or handling germinal products or transpor ting 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 an imals 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 burde ns and costs, particularly to small and 
medium size enterprises (SMEs), flexibility s hould be given to th e Member States to 
adapt the system of registration and appr oval to local and regional conditions and 
production patterns. 
(94) In the interest of redu cing administrative burdens, re gistration and approvals should, 
where possible, be integrated into a regist ration or approval system which Member 
State may already have establ ished for other purposes.  
(95) Operators have first-hand knowledge of  the animals under their care. They should 
therefore maintain up-to-date records of in formation 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 availabi lity of up-to-date information concerning the 
registered establishments and transporters and approved establishments the competent authority should establis h and keep a register of such establishments and transporters. 
The power to adopt acts in accordance w ith 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 re gister of establishments and transporters 
and the record keeping requirements, as regards the information to be recorded, 
derogations from the record keeping re quirements 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, implemen ting powers should be conferred to the 
Commission to lay down rules concerning the informati on obligations, exemptions 
and other rules, the formats and operational sp ecifications of the re gisters and records. 
(98) Efficient traceability is  a key element of disease c ontrol policy. Identification and 
registration requirements specifi c for the different species of kept terrestrial animals 
and germinal products should be in place in or der to facilitate the effective application 
of the disease prevention and control rules pr ovided for in this re gulation. In addition, 
it is important to provide for the possibili ty 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 ac ts 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 25   EN competent authority, detailed identification and registration require ments for different 
animal species and documents.  
(100) It is appropriate to re duce administrative burdens and co sts and provide for flexibility 
of the system in circumstances where the tr aceability requiremen ts can be achieved by 
means other than those set out in this Re gulation. The Commission should therefore be 
empowered to adopt delegated acts in accord ance with Article 290 of the Treaty on the 
Functioning of the European Union concerni ng the derogations from the identification 
and registration requirements. 
(101) In order to ensure uniform conditions fo r the implementation of the identification and 
registration system and traceability, impl ementing powers should be conferred on the 
Commission to lay down rules concerning the technical specifications for databases, 
means of identification, documents and fo rmats, the deadlines, and criteria for 
derogations from such systems. 
(102) An important tool for preventing the intr oduction and spread of a transmissible animal 
disease is the use of restrictions on m ovements of animals and products that may 
transmit that disease. However, restricti ng 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 move ment of animals from an establishment 
where there are abnormal mortalities or othe r disease symptoms with an undetermined 
cause or disease prevention requ irements 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 Me mber States, while leaving it up to the 
Member States to determine the necessary movement requirements within their territory. A comparison of the current si tuation with an option where rules for 
movements within Member States would al so be harmonised at Union level, was 
extensively elaborated in the Impact Assessm ent on the EU Animal Health Law. It has 
been concluded that the current appro ach should be mainta ined, as complete 
harmonisation of all movements would be very  complex and the benefits in terms of 
the facilitation of movements between Member Stat es do not outweigh the negative 
impact this could have on the ability to control diseases.  
(105) For animals that are moved between Memb er States a set of basic animal health 
requirements apply. In particul ar, 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 authoris ed under Directive 
2010/63/EU of the European Parliament a nd of the Council of 22 September 2010 on 
the protection of animals used for scientific purposes
26 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. EN 26   EN (106) However, this Regulation should provide fo r 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 cas es where Member St ates 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 anim al species of high economic significance and 
are subject to specific movement requireme nts under Union legislation adopted prior 
to this Regulation, namely Council Direct ive 64/432/EEC of 26 June 1964 on animal 
health problems affecti ng intra-Community trade in  bovine animals and swine
27, 
Council Directive 91/68/EEC of 28 Janua ry 1991 on animal health conditions 
governing intra-Community trade in ovine and caprine animals28, Council Directive 
2009/156/EC of 30 November 2009 on anim al 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 thir d 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 h ealth 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 s hould 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 anim als 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 ru les in this Regulation to protect the health 
of the animals involved and prevent the sp read of transmissible animal diseases. 
(109) Depending on the listed diseas es and listed species,  it is necessary to  lay down specific 
animal health requirements for certain anim al species other than kept ungulates and 
poultry. Rules for these species were also la id 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 shoul d therefore provide a legal basis for the 
adoption of delegated and implementing act s 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 bi osecurity, a favourable  and well controlled 
health status and are subject to fewer m ovements or movements solely within the 
closed circuits of those establishments. Th e status of confined establishments, for 
which the operators may apply for on a vol untary basis, was first introduced in 
                                                
 
27 OJ 121, 29.7.1964, p. 1977. 
28 OJ L 46, 19.2.1991, p. 19. 
29 OJ L 192, 23.7.2010, p. 1. 
30 OJ L 343, 22.12.2009, p. 74. 
31 OJ L 268, 14.9.1992, p. 54. EN 27   EN Directive 92/65/EEC, where rules and re quirements 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 ti me providing health gua rantees within the 
circuit of confined establishments. Ther efore it has been broadly accepted by the 
operators, and used as a volunt ary option. It is therefore a ppropriate to preserve the 
concept of confined establis hments 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 Directiv e 2010/63/EU, it may be necessary to move 
animals which do not comply with the gene ral animal health requirements laid down 
in this Regulation and repr esent a higher animal heal th risk. Those kinds of 
movements should not be prohibited or undul y 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 t hose animals take place in a safe manner. 
(112) Movement patterns of ci rcus animals, animals kept in zoos, animals intended for 
exhibition and certain other animals often de viate from the moveme nt patterns of other 
kept species. Specific cons ideration should be taken in adapting Union rules on 
movement to such animals, taking into a ccount specific risks and alternative risk 
mitigation measures.  
(113) In order to ensure that  the objectives of re citals 102 to 112 of this Regulation are 
achieved, the power to adopt acts in accord ance with Article 290 of the Treaty on the 
Functioning of the European Union s hould 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 require ments or derogations for other types of 
movements, such as movement for scientific purposes. 
(114) In order to ensure the po ssibility 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 th e 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 technica lly, practically and financia lly feasible, technological 
developments should be availed of to re duce the administrative burdens on operators 
and the competent authority in relation to certification and notification by using information technology to replace the pape r documentation and faci litate notification 
procedures and using them as far as possible for multiple purposes.  
(117) In cases where an animal  health certificate issued by the competen t authority is not 
required, an operator who moves animals to another Member State should issue a self-EN 28   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 th e 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 the co ntent, information obligations, and 
derogations from the animal health certif ication requirements, specific certification 
rules and the obligations of official veterinarians to c onduct appropriate checks before 
the signing the animal health certificate.  
(119) Notification of movements of animals an d germinal products be tween 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 register ed. 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 o fficial activities performed to ensure the 
application of food and feed la w, rules on animal health an d welfare, plant health and 
plant reproductive material, plant protecti on 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 fo r the implementation of the rules laid down in 
this Regulation on animal health cer tification and movement notification, 
implementing powers should be conferred on the Commission to lay down rules concerning the model animal health certific ates, self-declaration documents, formats 
and deadlines for movement notification fo r both terrestrial and aquatic animals, 
germinal products and where also rele vant, products of animal origin.  
(121) The specific nature of movements of pet animals represents an animal health risk 
which deviates significantly from that of ot her 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 si gnificant risk for the spread of transmissible animal 
diseases, the power to adopt acts in accord ance 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 anim al health requirement s laid down in this 
Regulation concerning the movements of pet animals, implementing powers should be 
conferred on the Commission to lay down ru les concerning the disease prevention and 
control measures to be taken for such movements.  
(122) Wild animals may for various reasons repr esent an animal and public health risk, for 
example, if they are moved into an estab lishment or from one environment to another 
environment. Appropriate preventive meas ures for movement of those animals may 
need to be taken to avoid th e spread of transmissible animal diseases. In order to 
                                                
 
32 OJ L … EN 29   EN ensure that wild animals do not pose a signif icant 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 Uni on should be delegated to the Commission, 
concerning the additional requirements for movements of wild terrestrial animals. 
(123) Germinal products can re present a similar risk of sp reading transmissible animal 
diseases to live animals. In addition, ther e are specificities in their production, which 
are related to high health demands for breed ing animals and which call for stricter or 
particular animal health requirements concer ning the donor animals. In order to ensure 
safe movements of germinal pr oducts, their expected high he alth standard and to take 
into account some specific uses, the power to adopt acts in accordance with Article 
290 of the Treaty on the Functioni ng of the European Union should be delegated to the 
Commission, concerning the deta iled requirements for move ment of germinal products 
of certain animal species, special requireme nts, such as for example their movement 
for scientific purposes, and derogations from th e animal health certification obligation.  
(124) Products of animal origin can represent a risk for the spr eading 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 Artic le 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 a nd the risk mitigating measures in place 
permit so. .  
(125) When Member States take national meas ures concerning movements of animals and 
germinal products or decide to take na tional measures to limit the impact of 
transmissible animal diseases other than li sted 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 appropr iate 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 transmissible animal dis eases. Directive 2006/88/EC requires all 
establishments which move aquatic animal s to be authorised. That system of 
authorisation should be main tained under this Regulation,  notwithstanding that fact 
that in some official EU languages, diffe rent terms are used for this system of 
authorisation in this Regulation as  compared to Directive 2006/88/EC. 
(127) The slaughter and processing of aquacu lture animals which are subject to disease 
control measures may spread transmissible an imal disease, for example as a result of 
effluents containing pathogens being discharg ed 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 30   EN Regulation should provide for the approv al of disease control aquatic food 
establishments. 
(128) In order to ensure th e 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 fo r the implementation of the rules laid down in 
this Regulation for the registration and a pproval of aquaculture establishments and 
disease control aquatic food establishmen ts, record keeping and registers of 
establishments, implementing powers should be conferred on the Commission to lay 
down rules concerning the informati on obligations, derogations and other 
implementing rules, and the format and opera tional specifications of the registers and 
records. 
(130) As it is not feasible in most cases to i ndividually 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 provi ded for in this Regulation. However, to 
encourage Member States to enhance the h ealth status of their aquatic populations, 
some adjustments and added flexibility should be introduced.  
(134) In order to ensure movement control fo r 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, con cerning the disease preventive measures 
applicable to transport, specific rules for movements of certain ca tegories of aquatic 
animals for different purposes, specific requ irements or derogations for certain types 
of movements, such as movement for scie ntific purposes and a dditional requirements 
for movement of wild aquatic animals. 
(135) In order to ensure the possibility of temporary deroga tions 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 Co mmission for laying 
down special movement rules or dero gations for a limited period of time. EN 31   EN (136) Union aquaculture production is extremel y diverse as regards species and production 
systems and this diversification is rapidl y 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, necessa ry and proportionate to the goals to be 
achieved. Furthermore, they should not a ffect 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 sp ecies other than those defined as terrestrial 
and aquatic by this Regu lation, such as reptiles, amphibian s, insects and others only to 
a very limited extent. It is therefore not appr opriate to require that  all the provisions of 
this Regulation apply to those animals. Howe ver, if a disease which concerns species 
other than terrestrial and a quatic should become listed, th e relevant animal health 
requirements of this Regulation should apply to  those species to ensure that adequate 
and proportionate disease prevention a nd control measures may be taken. 
(138) In order to ensure the possibility of la ying down movement rules for those animals that 
are not defined as terrestrial and aquatic  animals by this Regul ation, 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 require ments, animal health certification and 
self-declaration and movement notification obl igations for animals,  germinal products 
and products of animal origin of those species.  
(139) When necessary to ensure uniform condi tions 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 rule s concerning those requirements.  
(140) To prevent the introduction of listed diseas es and emerging diseases into the Union, it 
is necessary to have in place efficient rule s 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 a nd products into the Union should mirror the 
requirements for movements of animal and pr oducts of the same category, species and 
intended use within the Union. 
(142) To ensure that animals, germinal produc ts and products of animal origin from third 
countries or territories comply with the animal health require ments that provide 
guarantees that are equivalent to those provi ded for in Union legisl ation, it is essential 
that they are subject to appropriate contro ls by the competent authority of the third 
countries or territories expor ting to the Union. Where releva nt, 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 th ey meet the animal health 
standards for entry of the animals and produc ts into the Union should be eligible to 
export them to the Union and be listed for that purpose.  EN 32   EN (143) For some species and cate gories of animals, germinal pr oducts and produc ts 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 dete rmine from which countries 
and territories those animals, germinal produc ts and products of animal origin may be 
permitted to enter their territory. In so determining, Memb er States should take into 
account the criteria laid down in this Regulation for the Un ion lists of third countries 
and territories. 
(144) To ensure that the animal  health requirements for the en try into the Union provided for 
in this Regulation are complied with and ar e in line with the principles of the OIE 
Animal Health Codes, all animals, germin al products and products of animal origin 
entering the Union should be accompanied by an animal health ce rtificate issued by 
the competent authority of the third country or  territory of origin confirming that all 
the animal health requirements for entry in to 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 th eir own, but certification is often required in 
Union legislation for other purposes, for ex ample 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 administ rative burdens and costs those 
animal health certificates should also be permitted to include information required under other Union food and f eed 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 pr oducts, materials that may have been in 
contact with infected animals and equi pment may also spread disease. Where 
necessary, measures should be taken to prev ent 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 accordan ce with Article 290 of the Treaty on the 
Functioning of the European Union shoul d be delegated to the Commission, to 
supplement and amend the criteria for the lis ting of third countri es and territories, 
criteria for the suspension or  withdrawal from that list, supplementing the rules for the 
approval of establishments in third countri es and territories a nd derogations, animal 
health requirements for the en try into the Union of consignments from third countries 
and territories, contents of animal health certificates, and the animal health requirements for disease agents, other materi als, 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, im plementing 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 33   EN (149) Past experience has shown that when an  outbreak of a serious  disease occurs in 
Member States or in third c ountries or territories  from which animals or products enter 
the Union, disease prevention and control meas ures have to be taken immediately to 
limit its introduction and spread. Such an emergency may involve listed diseases, emerging diseases or other anim al health hazards. In that context, it sh ould 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 measur es would restrict movement within or 
into the Union they should be implemen ted 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 Commi ssion to lay down emergency measures. 
(151) The Commission should adopt immediat ely applicable implementing acts in duly 
justified cases relating to inter alia the li sting 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 territori es for entry into the Union. 
(152) This Regulation lays down general and sp ecific rules for the prev ention and control of 
transmissible animal diseases and ensures a harmonised approach to animal health 
across the Union. In some areas, such as ge neral responsibilities for animal health, 
notification, surveillance, registration and a pproval or traceability, the Member States 
should be allowed or encouraged to appl y 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 th erein and provided that  they do not hinder 
movements of animals and products between Me mber 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 re cital 152 should be s ubject to a simplified 
notification procedure in order to redu ce the administrative burden. Experience has 
shown that the general notification procedur e laid down in Direct ive 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 stan dards and regulations and of 
rules on Information Society services
33, has been an important tool for guiding and 
improving the quality of national technica l regulations – in terms of increased 
transparency, readibility and effectiveness,  in non-harmonised or partly harmonised 
areas. It is therefore appropriate that this  general notification pr ocedure 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 a nd in subsequent Co mmission acts adopted 
pursuant to them:  
                                                 
33 OJ L 204, 21.7.1998, p. 37. EN 34   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 brucellosi s, tuberculosis and leucosis in cattle35,  
– Council Directive 78/52/EEC of 13 December 1977 establishing the 
Community criteria for national plan s for the accelerated eradication of 
brucellosis, tuberculosis a nd enzootic leukosis in cattle36,  
– Council Directive 88/407/EEC  of 14 June 1988 laying down the animal health 
requirements applicable to intra-Commun ity 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 territor y 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 tr ade 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- Commun ity 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 impor ts into the Community of animals, 
semen, ova and embryos not subject to an imal health requirements laid down 
                                                 
34 OJ 121, 29.7.1964, p. 1977. 
35 OJ L 145, 13.6.1977, p. 44. 
36 OJ L 15, 19.1.1978, p. 34. 
37 OJ L 194, 22.7.1988, p. 10. 
38 OJ L 325, 1.12.1980, p. 1. 
39 OJ L 378, 31.12.1982, p. 58. 
40 OJ L 302, 19.10.1989, p. 1. 
41 OJ L 224, 18.8.1990, p. 62. 
42 OJ L 46, 19.2.1991, p. 19. 
43 OJ L 368, 31.12.1991, p. 21. 
44 OJ L 157, 10.6.1992, p. 19. EN 35   EN in specific Community rules referre d 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/EEC
47,  
– Council Directive 92/119/EEC of 17 December 1992 introducing general 
Community measures for the control of certain animal dis eases 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 sla ughter intended for 
Finland and Sweden49, 
– Council Directive 2000/75/EC of 20 N ovember 2000 laying down specific 
provisions for the control a nd eradication of bluetongue50,  
– Council Decision 2000/258/EC of 20 March 2000 designating a specific 
institute responsible for establishing the criteria necessary fo r standardising the 
serological tests to monitor the effectiveness of rabies vaccines51, 
– Regulation (EC) No 1760/2000 of the Eur opean Parliament and of the Council 
of 17 July 2000 establishing a system for the identification and registration of 
bovine animals and regarding the labell ing of beef and beef products and 
repealing Council Regulation (EC) No 820/9752,  
– Council Directive 2001/89/EC of 23 Oc tober 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 fever
54,  
                                                 
45 OJ L 268, 14.9.1992, p. 54. 
46 OJ L 260, 5.9.1992, p. 1. 
47 OJ L 62, 15.3.1993, p. 49. 
48 OJ L 62, 15.3.1993, p. 69. 
49 OJ L 243, 11.10.1995, p. 25. 
50 OJ L 327, 22.12.2000, p. 74. 
51 OJ L 79, 30.3.2000, p. 40.   
52 OJ L 204, 11.8.2000, p. 1. 
53 OJ L 316, 1.12.2001, p. 5. 
54 OJ L 192, 20.7.2002, p. 27. EN 36   EN – Council Directive 2002/99/EC of 16 D ecember 2002 laying down the animal 
health rules governing the production, pr ocessing, 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-a nd-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/XX XX of the European Parliament and of the 
Council of …. on the non-commercial move ment 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 regist ration 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 Apr il 2004 laying down animal health 
rules for the importation into and trans it through the Community  of certain live 
ungulate animals, amending Directiv es 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 D ecember 2005 on Community measures 
for the control of avian influen za and repealing Di rective 92/40/EEC61,  
– Council Directive 2006/88/EC of 24 October 2006 on animal health 
requirements for aquaculture animal s and products thereof, and on the 
prevention and control of certain diseases in aquatic animals62,  
– Council Directive 2008/71/EEC of 15 Ju ly 2008 on the identification and 
registration of pigs (codi fying 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 eggs
64.  
                                                 
55 OJ L 18, 23.1.2003, p. 11. 
56 OJ L 306, 22.11.2003, p. 1. 
57 OJ L … 
58 OJ L 5, 9.1.2004, p. 8. 
59 OJ L 139, 30.4.2004, p. 321. 
60 OJ L 192, 23.7.2010, p. 1. 
61 OJ L 10, 14.1.2006, p. 16. 
62 OJ L 328, 24.11.2006, p. 14. 
63 OJ L 213, 8.8.2008, p. 31. 
64 OJ L 343, 22.12.2009, p. 74. EN 37   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 Commissi on acts to be adopted pursuant to this 
Regulation. Accordingly, those legislative act s should be repealed. However, to ensure 
legal clarity and avoid a legal vacuum, the re peal should only take effect when the 
relevant delegated and impleme nting acts are adopted pursuant to this Regulation. It is 
therefore necessary to provide the Commi ssion 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 clar ity of Union legislation: Council Decision 
78/642/EEC of 25 July 1978 on health protectio n 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 eradi cation 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 introd ucing Community measures for the 
control of foot-and-mouth disease69; Council Decision 90/678/EEC of 13 December 
1990 recognizing certain parts of the territ ory 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 Comm ission 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 th e 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 applica tion of rules for identification 
and registration of animals, disease contro l measures for certain zoonoses and non-
commercial movements of pet animals, the po wer 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 la ying down the rules and gene ral principles concerning 
                                                 
65 OJ L 213, 3.8.1978, p. 15. 
66 OJ L 29, 3.2.1979, p. 24. 
67 OJ L 14, 16.1.1981, p. 22. 
68 OJ L 223, 2.8.1989, p. 19. 
69 OJ L 224, 18.8.1990, p. 13. 
70 OJ L 373, 31.12.1990, 29. EN 38   EN mechanisms for control by the Member States of the Commission's exercise of 
implementing powers71. 
(160) It is of particular importance that th e 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 documen ts 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, th e 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 pr otect animal health and public health. 
However, a number of derogations for such  enterprises should be provided for in 
relation to the different requirements of th is Regulation, taking in to account the risks 
involved.  
(162) The objectives of this Re gulation, namely to lay down anim al 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 Memb er 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 principl e 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 orde r 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 39   EN (a) the prioritisation and categorisation of diseases of Union concern and for 
establishing responsibilities for animal health in Part I; 
(b) the early detection, no tification and reporting of diseases, surveillance, 
eradication programmes and dis ease-free status in Part II; 
(c) disease awareness, prepare dness and control in Part III; 
(d) the registration and approval of esta blishments and transporters, movements 
and traceability of consignm ents of animals, germinal products and products of 
animal origin within the Union in Part IV; 
(e) the entry of consignments of animal s, 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 take n 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 a quaculture 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 a nd environmental consequences arising 
from the application of disease control and prevention measures. EN 40   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) animal by-products and derived products, without prejudice to the rules laid 
down in Regulation (EC) No 1069/2009; 
(e) 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 appl y 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, app roval, 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 te rrestrial animals and aquatic animals in 
Article 4(1)(4); EN 41   EN (b) germinal products and products of an imal 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, terre strial mammals, bees and bumble bees; 
(3) 'aquatic animals' means animals of th e following species, at  all life stages, 
including eggs, sperm and gametes: 
(i) fish belonging to the superc lass Agnatha and to the classes 
Chondrichthyes, Sarcopterygii and Actinopterygii; 
(ii) aquatic molluscs belongi ng to the phylum Mollusca; 
(iii) aquatic crustaceans belongi ng to the subphylum Crustacea; 
(4) 'other animals' means animals of species other than those defined as terrestrial 
and aquatic animals; 
(5) 'kept animals' means animals which are kept by humans; in the case of aquatic 
animals, aquaculture animals; 
(6) '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 wh ich 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 rear ed or kept in captivity for:  
(a) the production of:  
(i) meat; (ii) eggs for consumption; (iii) other products;  EN 42   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 th e 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 natura l person acting on behalf of and in 
agreement with the pet keeper, and which remains during such non-commercial movement under the responsib ility 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 financ ial gain or a transfer of 
ownership; 
(14) 'disease' means the occurrence of infections  and infestations in animals, with or 
without clinical or pathological manife stations, 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) a new disease resulting from the evolution or change of an existing 
disease agent;  
(b) a known disease spreading to a ne w geographic area or  a new population; 
or 
(c) a previously unrecognised disease agent or a disease diagnosed for the 
first time; 
(17) 'disease profile' means the criteria of a di sease 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 th e case of emerging diseases, animal 
species or groups of animal species, whic h meet the criteria for listed species 
laid down in Article 7(2); EN 43   EN (19) 'hazard' means a disease agent in, or a condition of, an animal or product with 
the potential to have an adverse heal th effect in humans or animals; 
(20) 'risk' means the likelihood of the occu rrence 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 manageme nt and physical measures designed to 
reduce the risk of the introduction, developm ent and spread of diseases to, from 
and within:  
(a) an animal population, or  (b) an establishment, zone, compartmen t, 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 ke epers 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, ot her than operators or veterinarians; 
(24) 'establishment' means any premises, stru cture, or any environment, in which 
animals or germinal produc ts are kept, except for: 
(a) households keeping pet animals;  (b) non-commercial aquaria k eeping aquatic animals;  
(c) veterinary practices or clinics; 
(25) 'germinal products' means:  
(a) sperm, semen, oocytes and embryos intended for artifici al reproduction;  
(b) hatching eggs; 
(26) 'products of animal origin' means:  
(a) food of animal origin, including honey and blood; 
(b) live bivalve molluscs, live echinod erms, live tunicates and live marine 
gastropods intended for hu man consumption; and 
(c) 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 obtain ed from animals which are not intended 
for human consumption, excluding germinal products;  EN 44   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 contro l as defined in point (1) of Article 2 of 
Regulation (EU) XXX/XXX [Publication office – Number to be added: on 
official controls and ot her 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 de fined part of a Member State, third 
country or territory containing an animal subpopulation with a distinct 
health status with respect to a specifi c disease or specific diseases subject 
to appropriate surveillance, disease control and biosecu rity measures;  
(b) for aquatic animals a contiguous h ydrological system with a distinct 
health status with respect to a specifi c 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 45   EN (v) an estuary with a precise  geographical delimitation; 
(33) 'water catchment' means an area or ba sin of land bounded by natural features 
such as hills or mountains, into  which all run-off water flows; 
(34) 'compartment' means an animal subpopul ation contained in one or more 
establishments and in the case of aquatic animals in one or more aquaculture establishments, under a common biosecu rity management system with a 
distinct health status with respect to a specific disease or specific diseases 
subject to appropriate surveillance, di sease control and biosecurity measures; 
(35) 'quarantine' means the maintaining of an imals 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 wh ich restrictions on the movements of 
certain animals or products and other disease control meas ures 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 confirma tion 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 collecti on, production, processing and storage of 
germinal products;  
(b) a hatchery; EN 46   EN (45) 'hatchery' means an establishment which collects, stores, in cubates and hatches 
eggs for the supply of: 
(a) eggs for incubation; (b) day-old chicks or hatc hlings of other species; 
(46) 'transporter' means an operator trans porting animals on its own account, or for 
a third party; 
(47) 'confined establishment' means any permanent, geogra phically limited 
establishment, created on a voluntary ba sis, and approved for the purpose of 
movements, where the animals are:  
(a) kept or bred for the purposes of e xhibitions, education, the conservation 
of species or research; 
(b) confined and separated from the surrounding environment; 
(c) subject to strict animal health su rveillance and biosecurity measures; 
(48) 'assembly operation' means the assembli ng 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 peri od an animal is required to stay at 
an establishment prior to being moved from that establishment; 
(50) 'IMSOC' means the computerised info rmation management system provided 
for by Article 130(1) of Re gulation (EU) No. XXX/XXX [Publication office: 
Number to be added  -on official controls and ot her official activities] ; 
(51) 'disease control aquatic food establishmen t' 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 accordan ce with Title II of Part III. 
2. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning amen dments to the list of: 
(a) pet animals set out in Annex I; (b) ungulates set out in Annex II.  EN 47   EN Chapter 2 
Listed diseases and emerging  diseases and listed species 
Article 5 
Listing of diseases 
1. The disease specific rules for the preventi on and control of diseases provided for in 
this Regulation shall apply to:  
(a) listed diseases;  (b) emerging diseases. 
2. The Commission shall, by means of impl ementing 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 para graph, taking into acc ount the criteria for 
listing diseases laid down in Article 6: 
(a) diseases which are likely to have a si gnificant impact on at  least one of the 
following: 
(i) public health;  (ii) agricultural or aquacu lture 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 meas ures 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 urge ncy relating to a disease representing an 
emerging risk of highly significant impact  the Commission shall adopt immediately 
applicable implementing acts in accordan ce with the procedure referred to in 
Article 255(3). 
Article 6 
Criteria for listing diseases  
1. The Commission shall take ac count of the follo wing criteria in determining whether 
a disease meets the conditions to be lis ted in accordance with Article 5(2):  EN 48   EN (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 transmissi on of the disease between animals and 
when relevant between animals and humans; 
(vii) the absence or presence and distri bution 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 diagnos tic and disease control tools; 
(b) the impact of the disease on:  
(i) agricultural and aquaculture produc tion 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 situ ation 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; EN 49   EN (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 th e affected sectors and the economy as a 
whole; 
(ii) their societal acceptance; (iii) the welfare of affected subpopulat ions of kept and wild animals;  
(iv) the environment and biodiversity. 
2. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 253 concerning amendments to the crit eria provided for in paragraph 1 of this 
Article to take account of technical and sc ientific progress and the developments of 
relevant international standards. 
Article 7 
Listing of species 
1. The disease specific rules for listed diseases  provided for in this Regulation and the 
rules adopted pursuant to this Regula tion shall apply to listed species. 
2. The Commission shall, by means of implemen ting acts, establish a list of species, as 
referred to in paragraph 1.  
That list shall comprise those animal speci es or groups of animal species, which pose 
a considerable risk for the spread of speci fic listed diseases, taking into account the 
following criteria: 
(a) the susceptibility of th e 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 urge ncy relating to a disease representing an 
emerging risk of highly significant impact  the Commission shall adopt immediately 
applicable implementing acts in accordan ce with the procedure referred to in 
Article 255(3). EN 50   EN Article 8 
Application of disease prevention and control rules to listed diseases 
1. The Commission shall, by means of implem enting acts, determine the application of 
the disease prevention and control rules refe rred to in the following points to listed 
diseases: 
(a) listed diseases s ubject to rules on: 
(i) disease awareness and preparedness pr ovided 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 di sease prevention and control rules on: 
(i) compulsory eradication program mes provided for in Article 30(1); 
(ii) disease-free Member States a nd zones provided for in Article 36; 
(iii) compartmentalisation pr ovided 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 di sease prevention and control rules on: 
(i) voluntary eradication provided for in Article 30(2); (ii) disease-free Member States a nd zones provided for in Article 36; 
(iii) compartmentalisation pr ovided 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 di sease prevention and control rules on: 
(i) movement within the Union provided fo r 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 fr om the Union provided for in Part V; 
(e) listed diseases subject to the dis ease prevention and control rules on:  
(i) notification and reporting provide d 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 urge ncy relating to a disease representing an 
emerging risk of highly significant impact  the Commission shall adopt immediately EN 51   EN applicable implementing acts in accordan ce 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 distri bution of the disease in the Union;  
(c) the availability, feasibility and effectiveness of the different sets of disease 
prevention and control measures provided fo r 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 professi onals and pet keepers shall: 
(a) be responsible for the health of kept animals and pr oducts under their 
responsibility; 
(b) 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 multip lication 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 a dopt delegated acts in accordance with 
Article 253 concerning biosecu rity measures supplementi ng the rules laid down in 
paragraph 1(b) of this Article. EN 52   EN Article 10 
Basic knowledge of animal health 
1. Operators and animal professi onals shall acquire knowledge of: 
(a) animal diseases, including those that are transmissible to humans;  
(b) biosecurity principles;  (c) the interaction between animal heal th, animal welfare and human health.  
2. The content and the level of knowledge re quired in accordan ce with paragraph 1 
shall depend on: 
(a) the categories and species of ke pt animals or products under their 
responsibility; 
(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 experi ence 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) take all appropriate measures to prevent the introduction, development and 
spread of diseases; 
(b) ensure the early detection of dis eases 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;  EN 53   EN (ii) disease prevention;  
(iii) the early detection and ra pid response to diseases.  
(d) cooperate with the competent authorit y, operators, animal professionals and pet 
keepers in the application of the di sease prevention and control measures 
provided for in this Regulation. 
2. Aquatic animal health pr ofessionals may undertake activities attributed to 
veterinarians under this Regula tion in relation to aquatic animals provided that they 
are authorised to do so under national legisl ation. In that event, paragraph 1 shall 
apply to those aquatic animal health professionals. 
3. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 253 concerning the quali fications of veterinarians and aquatic animal health 
professionals undertaking activ ities which fall within the scope of this Regulation. 
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) qualified personnel, facilities, equipmen t, financial resources and an effective 
organisation covering the whole te rritory of the Member State; 
(b) access to laboratories with qualified personnel, facilities, equipment and 
financial resources to ensure the rapid and accurate diagnosis and differential diagnosis of listed diseas es and emerging diseases; 
(c) sufficiently trained veterinarians invo lved 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 knowledg e of animal health provided for in 
Article 10 through relevant programmes in agricultural or aqu aculture sectors or 
formal education. EN 54   EN Article 13 
Competent authority's delegati on of other official activities 
1. The competent authority may delegate one or more of the following activities to 
veterinarians:  
(a) activities concerning notification and re porting as provided for in Chapter 1 of 
Part II and surveillance as provide d 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 a dopt delegated acts in accordance with 
Article 253, concerning:  
(a) the circumstances and conditions for de legating the activities provided for in 
paragraph 1; 
(b) which other activities may be delegate d 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 traini ng of veterinarians provided for in 
Article 12(1)(c). 
The Commission shall take account of the natu re of those tasks a nd the international 
obligations of the Union and the Member St ates, when adopting those delegated acts.  
Article 14 
Public information 
Where there are reasonable grounds to suspect that animals or pr oducts 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 abou t to be taken to prevent or control that risk, 
taking into account the nature, seriousness and exte nt of that risk and the public interest in 
being informed. EN 55   EN 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 dise ase agents, vaccines and other 
biological products 
1. 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 in to account international standards where 
they exist: 
(a) take appropriate bios ecurity, 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 diseas e agents, vaccines and other biological 
products between laboratories or other facil ities does not give rise to a risk of 
the spread of listed and emerging diseases. 
2. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning the safety measures fo r the laboratories, facilities and other 
natural or legal persons handling the dis ease agents, vaccines and other biological 
products in relation to:  
(a) biosecurity, biosafety an d bio-containment measures; 
(b) movement requirements for disease agents, vaccines and other biological 
products. EN 56   EN 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) 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); 
(b) a veterinarian of abnor mal mortalities and other serious disease signs or 
significant decreased producti on rates with an undeterm ined cause in animals 
for further investigation, including sa mpling for laboratory examination when 
the situation so warrants.  
2. Member States may decide that notifications  provided for in paragraph 1(b) shall be 
directed to the competent authority. 
3. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 253 concerning: 
(a) criteria to determine whether the ci rcumstances requiring notification described 
in paragraph 1(b) of this Article occur; 
(b) detailed rules for the further investigati on provided for in para graph 1(b) of this 
Article. 
Article 17 
Union notification  
1. Member States shall immediately notif y the Commission and the other Member 
States of any outbreaks of lis ted diseases referred to in Article 8(1)(e) for which an 
immediate notification is required to ensu re the timely implementation of necessary 
risk management measures, taking into account the disease profile. 
2. The notification provided for in paragra ph 1 shall contain the following information 
on the outbreak:  
(a) the disease agent and, where relevant, the subtype; EN 57   EN (b) the dates of the suspicion a nd 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 implem enting acts establish which of the listed 
diseases referred to in in Article 8(1)(e) sh all 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 Comm ission and to the othe r Member States the 
information on listed diseases referred to  in in Article 8(1)(e) for which: 
(a) an immediate notification of outbreak s is not required in accordance with 
Article 17(1);  
(b) 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 accord ance with the rules laid down in an 
implementing act adopted in accordance with Article 35.  
2. The reports provided for in paragrap h 1 shall include information on:  
(a) the detection of the listed dis eases referred to in paragraph 1; 
(b) the results of surveillance when required in accordance with rules adopted in 
accordance with Arti cle 29(b)(ii);  
(c) the results of surveillance programme s when required in accordance with 
Article 27(3) and rules adopted in accordance with Article 29(b)(ii);  
(d) eradication programmes when required in accordance with Article 33 and rules 
laid down in an implementing act adopt ed in accordance with Article 35. EN 58   EN 3. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 253 concerning amending and suppl ementing the requirements of paragraph 
2 of this Article and reporting on other matte rs where necessary to ensure an efficient 
application of the diseas e prevention and control ru les of this Regulation.  
Article 19 
Common rules for Union notification and Union reporting 
1. 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 mana gement measures, taking into account: 
(a) the disease profile; (b) the type of outbreak. 
2. The Member States shall establish notification and reporting regions for the purpose 
of the Union notification and Union repor ting provided for in Articles 17(1) and 
18(1). 
Article 20 
Computerised information system for Union notification and Union re porting of diseases  
The Commission shall set up and manage a co mputerised 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 implemen ting 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) the information to be provided by the Me mber States in the Union notification and 
Union reporting provided for in Articles 17(1) and 18(1); 
(b) 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;  
(c) the format and structure of the data to be entered into the computerised information 
system provided for in Article 20;  
(d) 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). EN 59   EN 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 li sted diseases and emerging diseases, operators 
shall:  
(a) observe the health and behaviour of animals under th eir responsibility; 
(b) observe any changes in the normal produc tion parameters in the establishments, 
animals or germinal products under their re sponsibility, that may give rise to a 
suspicion of being caused by a liste d disease or emerging disease; 
(c) look for abnormal mortalities and other serious disease signs in animals under their 
responsibility. 
Article 23 
Animal health visits  
1. Operators shall ensure that establishments  under their responsibi lity 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 surve illance, quality assurance sche mes or official controls 
that the kept animals and type of establishment are subject to. 
Those animal health visits shall be at fr equencies 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 bios ecurity and other animal health matters, 
as relevant for the type of establishmen t and the categories and species of kept 
animals on the establishment. EN 60   EN Article 24 
Delegation of powers concerni ng 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 th e different types of establishments, to 
ensure that the purposes of the an imal 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. The competent authority shall conduct survei llance for the presence  of listed diseases 
referred to in Article 8(1)(e) and for emerging diseases.  
2. The surveillance shall be designed to ensu re the timely detection of the presence of 
the listed diseases referred to  in Article 8(1)(e) and emer ging diseases by collecting, 
collating and analysing rele vant information relating to the disease situation. 
3. 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, frequenc y, intensity, targeted  animal population, and 
sampling patterns of the surveillance provided fo r in Article 25(1) shall be appropriate and 
proportionate to the objectives of th e surveillance, taking into account:  
(a) the disease profile;  (b) the risk factors involved;  (c) the health status in:  
(i) the Member State, zone or compartm ent thereof subject to the surveillance; EN 61   EN (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 acco rdance with Article 22, or by other public 
authorities.  
Article 27 
Surveillance programmes 
1. The competent authority shall undertake surv eillance 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. 
2. Member State establishing a surveillance programme in accordance with paragraph 1 
shall inform the Commission and the other Member States thereof.  
3. Member State undertaking a surveillance pr ogramme in accordance with paragraph 1 
shall submit regular reports on the result s 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) the design, means, diagnostic methods , frequency, intensity , targeted animal 
population, and sampling patterns of the survei llance as provided for in Article 26;  
(b) the criteria for the official confirmati on 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 th e submission of surveillance programmes in 
accordance with Article 27(2) and regular reports in accordance with Article 
27(3); 
(iii) the period of applicati on of surveillance programmes. EN 62   EN Article 29 
Implementing powers  
The Commission shall by means of implemen ting acts, lay down requirements concerning 
surveillance and surveillance programmes pr ovided 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 survei llance 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 th e 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 eradicati on of or demonstration of freedom from 
that listed disease, to be carried out in the animal populations concerned by that 
disease and covering the rele vant parts of their territory  or the relevant zones or 
compartments thereof ("compul sory eradication programme"); 
(b) submit the draft compulsory eradic ation 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 deci de to establish a 
programme for the eradication of that listed disease to be carried out in the animal 
populations concerned by it a nd 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; EN 63   EN (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 signifi cant impact the Commission shall adopt 
immediately applicable implementing acts provi ded for in point (a) of this paragraph 
in accordance with the procedure provided for in Article 255(3). 
The Commission may, by means of implemen ting 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 a dopt delegated acts in accordance with 
Article 253 concerning: 
(a) the objectives, disease control strategies and intermediate targets of 
compulsory and voluntary eradication programmes; 
(b) derogations from the requirement for the submission of compulsory eradication 
programmes and voluntary eradication pr ogrammes 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 derogati ons from the requirement for approval 
of compulsory eradicatio n programmes and voluntary  eradication programmes 
provided for in (b). 
The Commission shall be empowered to a dopt 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 an d voluntary eradication programmes  
1. Compulsory eradication programmes a nd voluntary eradication programmes shall 
consist of at least the following measures: 
(a) disease control measures for the er adication 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 w ith the rules laid down in Article 26 to 
29 to demonstrate: EN 64   EN (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 a dopt 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 take n to avoid re-infection of the targeted 
animal population with the disease in question in establishments, zones and 
compartments; 
(c) the surveillance design, means, di agnostic methods, frequency, intensity, 
targeted animal population and sampling pa tterns 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 compulso ry and voluntary erad ication 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) a description of the epidemiological situation of the listed disease covered by the 
compulsory or voluntary eradication programme;  
(b) a description and demarcation of the geogr aphical and administrative area covered by 
the compulsory or voluntary eradication programme; 
(c) 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);  
(d) the estimated duration of the compulso ry or voluntary eradication programme; 
(e) the intermediate target s and the disease control st rategies for undertaking the 
compulsory or voluntary eradication programme; 
(f) an analysis of the estimated costs and benefits of the com pulsory or voluntary 
eradication programme. EN 65   EN 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 compulso ry or voluntary programmes; 
(b) a final report after its completion.  
Article 34 
Period of application of  eradication programmes 
1. Compulsory and voluntary eradica tion programmes shall apply until: 
(a) 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 
(b) 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 wit hdrawn 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 a dopt delegated acts in accordance with 
Article 253 concerning supplementing and amending the requirements provided for 
in paragraph 1 of this Article as regards th e period of applicati on 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 rule s provided for in Articles 30 to 33 on: 
(a) the submission of draft compulsory and draft voluntary eradic ation programmes for 
approval;  
(b) performance indicators; (c) the reporting to the Commission and othe r Member States on the results of the 
implementation of compulsory or vo luntary eradication programmes.  
Those implementing acts shall be adopted in  accordance with the examination procedure 
referred to in Article 255(2). EN 66   EN Chapter 4 
Disease-free status  
Article 36 
Disease-free Member States and zones  
1. A Member State may apply to the Commissi on 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) none of the listed species for the dise ase covered by the application for disease-
free status is present in the entire te rritory of the Member State or in the 
relevant zone or zones cove red by that application;  
(b) 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 th at application;  
(c) 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 dis ease has been demonstrated by: 
(i) an eradication programme comply ing with the rules laid down in 
Article 31(1) and rules adopted pursuant to paragraph 2 of that Article; or 
(ii) historical an d surveillance data. 
2. Applications by Member States for diseas e-free status shall include evidence to 
substantiate that the conditions for disease- free status laid down in paragraph 1 are 
fulfilled. 
3. 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  
1. A Member State may apply to the Commissi on 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 diseas es in its territory provided that:  EN 67   EN (a) the introduction of the listed diseas e or listed diseases covered by that 
application can be effectively prevented at compartment level, taking into account the disease profile; 
(b) the compartment covered by the application is subject to a single common 
biosecurity management system to ensu re the disease-free status of all 
establishments forming part of it; 
(c) 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 compartmen ts keeping aquaculture animals and 
products thereof. 
2. A Member State may apply to the Commi ssion 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 diseas e 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);  
(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; 
(c) 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;  
(d) 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 compartmen ts keeping aquaculture animals and 
products thereof. 
3. Applications by Member States for the recognition of disease-free status of 
compartments in accordance with paragra phs 1 and 2 shall include evidence to 
substantiate that the conditions laid dow n in those paragraphs are fulfilled.  EN 68   EN 4. The Commission shall, by means of im plementing acts recognise, subject to 
amendments where necessary, the disease-fr ee status of compartments, when the 
conditions provided for in paragrap hs 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 a dopt 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 need ed to substantiate disease-freedom; 
(ii) biosecurity measures; 
(b) 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; 
(c) compartments, which are located in th e 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) disease-free territory or zones as provided for in Article 36(1); 
(b) 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 concerni ng 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 a nd the evidence required to substantiate 
such claims, as provided for in Article 36(1)(a); EN 69   EN (ii) the criteria to be used to substantiate th at a disease agent or vector is not able to 
survive and the evidence required to substa ntiate 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 need ed to substantiate disease freedom; 
(v) biosecurity measures; (vi) restrictions and conditio ns for vaccination in diseas e free Member States and 
zones thereof; 
(vii) establishment of the zones separating the disease-free zones or zones under the 
eradication programme from the re stricted zones ("buffer zones"); 
(viii) zones which extend over the territo ry of more than one Member State; 
(b) derogations from the requirement for th e approval by the Commission of disease-free 
status for one or more listed diseases referre d 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 ru les adopted pursuant to point (a) of this 
Article; 
(c) the information to be provided by Member  States to the Commission and the other 
Member States to substantiate the declar ations of disease-fr ee status, without the 
adoption of an implementing act in accordan ce 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 delega ted acts adopted pursuant to Article 39 
concerning:  
(a) 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; 
(b) requirements concerning the information to be submitted, and the format and 
procedures for:  
(i) the applications for the disease-free stat us 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). EN 70   EN Article 41 
Maintenance of disease-free status 
1. Member States shall only maintain disease-fr ee status for their terr itories, or zones or 
compartments thereof as long as: 
(a) the conditions for disease-free status laid down in Article 36(1) and 37(1) and 
(2), and rules laid down pur suant to paragraph 3 of th is Article and Article 39 
remain fulfilled; 
(b) surveillance, taking into  account the requirements provi ded 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; 
(c) restrictions are applied on movements of animals, and where relevant their 
products, of listed species for the liste d disease for which the disease-free 
status was approved or rec ognised, 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. 
2. A Member State shall immediately inform the Commission if the conditions referred 
to in paragraph 1 for maintaining di sease-free status no longer apply.  
3. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning the following conditi ons for maintaining disease-free status: 
(a) surveillance as provide d for in paragraph 1(b); 
(b) biosecurity measures as pr ovided for in paragraph 1(c). 
Article 42 
Suspension, withdrawal and restorat ion of disease-free status 
1. Where a Member State has reason to su spect that any of the conditions for 
maintaining its status as a disease-free Member State, or zone or compartment 
thereof have been breach ed, it shall immediately: 
(a) suspend movements of the listed specie s, for the listed disease for which it was 
approved or recognised for disease-free st atus, 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, a pply 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  EN 71   EN (b) the suspected breach did not have signi ficant impact and the Member State can 
provide assurances that the conditions for maintaining its disease-free status are again fulfilled. 
3. Where further investigation by the Member  State confirms a significant likelihood 
that the listed disease for whic h 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. 
4. The Commission shall, by means of implemen ting acts, withdraw the approval of the 
disease-free status of a Member Stat e or zone granted in accordance with 
Article 36(3) or the recognition of the diseas e-free status of a compartment granted in 
accordance with Article 37(4) after obtaini ng 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 ex treme urgency, where the listed disease 
referred to in paragraph 3 of this Article spreads in a rapi d manner with risk of highly 
significant impact on animal or public health, the economy or society, the 
Commission shall adopt immediately app licable implementing acts in accordance 
with the procedure provided for in Article 255(3). 
5. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning the rules for the su spension, withdrawal and restoration of 
disease-free status provided for in pa ragraphs 1 and 2 of this Article. EN 72   EN 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. The Member States shall draw up and k eep up-to-date-continge ncy plans and where 
necessary detailed instruction manuals layi ng down the measures to be taken in the 
Member State in the event of the occurren ce 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, pr eparedness and rapid response. 
2. The contingency plans and where applicable  detailed instruction manuals shall cover 
at least the following matters:  
(a) the establishment of a chain of comma nd 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; 
(b) the framework for cooperation between the competent authority and the other 
public authorities involved to ensure th at 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 a nd resources necessary for the rapid and 
efficient eradication of the listed diseases referred to in Article 8(1)(a) or the emerging diseases;  EN 73   EN (d) the availability of the following centres and groups with the necessary 
expertise to assist the competent authority: 
(i) a functional central di sease control centre;  
(ii) regional and local disease control centres, as appropriate for the 
administrative and geographical s ituation of the Member States; 
(iii) operational expert groups; 
(e) the implementation of the disease contro l 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 demarcati on of the restricted  zones established 
by the competent authority in ac cordance with Article 64(1); 
(h) coordination with neighbouring Memb er States and neighbouring third 
countries and territories, where appropriate.  
Article 44 
Delegation of powers and implemen ting powers for contingency plans 
1. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 253 concerning deta iled 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 plan s to ensure a high level of disease 
awareness, preparedness and rapid response; 
(b) the disease profile of the listed dis eases referred to in Article 8(1)(a); 
(c) new knowledge of and developmen ts in disease control tools. 
2. The Commission shall, by means of im plementing acts, lay down requirements 
concerning the practical implementation in the Member States of the contingency 
plans provided for in Articl e 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 con tingency 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). EN 74   EN Article 45 
Simulation exercises  
1. The competent authority shall ensure th at simulation exercises concerning the 
contingency plans provided for in Arti cle 43(1) are carried out regularly: 
(a) to ensure a high level of disease awar eness, preparedness and rapid response in 
the Member State; 
(b) to verify the functionality of those contingency plans.  
2. Where feasible and appropriate, simulation exercises shall be carried out in close 
collaboration with the competent author ities of neighbouring Member States and 
neighbouring third countri es and territories.  
3. Member States shall make available on re quest a report on the main results of the 
simulation exercises to the Commissi on and to the other Member States. 
4. When appropriate and necessary the Co mmission shall, by means of implementing 
acts, lay down rules concerning the practi cal implementation of simulation exercises 
in the Member States on: 
(a) the frequencies, contents and format of simulation exercises; (b) simulation exercises covering more th an one listed disease referred to in 
Article 8(1)(a); 
(c) collaboration between neighbouring Me mber 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 co ncerning the use of veterinary medicinal 
products for listed diseases, to ensure the mo st efficient disease prevention or control 
for those diseases, provided that such measur es 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; EN 75   EN (b) the compulsory use of veterinary medicinal products. 
2. Member States shall take the following cr iteria into consideration when determining 
whether or not to use and how to use ve terinary 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 neighbouri ng third countries and territories;  
(iv) third countries and territories from which animals and products are 
brought into the Union; 
(c) the availability, effectiveness and ri sks of the veterinary medicinal products; 
(d) the availability of diagnostic tests fo r detecting infections  in animals treated 
with the veterinary medicinal products; 
(e) the economic, social, animal welfare and environmental impact of the use of 
the veterinary medicinal products co mpared to other available disease 
prevention and control strategies. 
3. Member States shall take appropriate pr eventive 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 a dopt 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 veteri nary 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 ve terinary medicinal products  or products from such 
animals; 
(e) surveillance following the use of v accines and other veterinary medicinal 
products for specific listed diseases. EN 76   EN 2. The Commission shall take into account th e criteria provided for in Article 46(2) 
when laying down the rule s provided for in paragraph 1 of this Article. 
3. Where in the case of emerging risks, imperative grounds of urgency so require, the 
procedure provided for in Article 254 shal l 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 antige n, vaccine and diagnostic reagent banks  
1. For listed diseases referred to in Ar ticle 8(1)(a) for which vaccination is not 
prohibited by a delegated act adopted pursu ant to Article 47(1), the Commission may 
establish and be responsible for managi ng Union antigen, vaccine and diagnostic 
reagent banks for the storage and replacemen t 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 Uni on antigen, vaccine and diagnostic reagent 
banks provided for in paragraph 1: 
(a) store sufficient stocks of the appropri ate type of antigens, vaccines, vaccine 
master seed-stocks and diagnostic reagen ts for the specific listed disease, 
taking into account the needs of Member St ates estimated in the context of the 
contingency plans provided for in Article 43(1); 
(b) receive regular supplies and timely repl acements of antigens, vaccines, vaccine 
master seed-stocks and diagnostic reagents;  
(c) are maintained and moved under the a ppropriate biosecurity, biosafety and bio-
containment standards as provided fo r in Article 15(1) and delegated acts 
adopted pursuant to Article 15(2); 
3. The Commission shall be empowered to a dopt 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; EN 77   EN (b) the biosecurity, biosafety and bio-co ntainment requirements for their operation 
taking into account the requirements provided for in Article 15(1) and 
delegated acts adopted purs uant to Article 15(2). 
Article 49 
Access to the Union antigen, va ccine and diagnostic reagent banks 
1. The Commission shall provide for the deliv ery 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) the existence of a national antigen, v accine and diagnostic reagent bank in the 
requesting Member State or third country or territory; 
(c) the existence of Union measures fo r compulsory vaccination laid down in 
delegated acts adopted purs uant to Article 47(1). 
Article 50 
Implementing powers concerning the Union an tigen, vaccine and diagnostic reagent banks 
The Commission shall, by means of implemen ting acts, lay down rules for Union antigen, 
vaccine and diagnostic reagent banks specifying for the biological products referred to in 
Article 48(1): 
(a) 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);  
(b) the types of those biological products th at 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; 
(c) the requirements concerning the supply, st orage and replacement of those biological 
products; 
(d) the delivery of those biological products from the Union antigen, vaccine and 
diagnostic reagent banks to the Member Stat es and to third count ries and territories; 
(e) procedural and technical requirements fo r the inclusion of those biological products 
in the Union antigen, vaccine and diagnosti c reagent banks and for requesting access 
to them. EN 78   EN Those implementing acts shall be adopted in  accordance with the examination procedure 
referred to in Article 255(2).  
On duly justified imperative grounds of urgenc y relating to a listed disease referred to in 
Article 8(1)(a) representing a risk of highly significant imp act the Commission shall adopt 
immediately applicable implementing acts in ac cordance with the procedure provided for in 
Article 255(3). 
Article 51 
Confidentiality of informati on concerning the Union antige n, vaccine and diagnostic reagent 
banks 
Information on the quantities and subtypes of th e biological products re ferred 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 na tional 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 Ar ticle 15(1)(a) and de legated 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) the existence or the establishment of  national antigen, vaccine and diagnostic 
reagent banks referred to paragraph 1; 
(b) the types of antigens, vaccines, vacci ne 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 implemen ting acts, lay down rules specifying the 
content, frequency, and format of the subm ission 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).  EN 79   EN 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  
Article 53  
Obligations of operators, animal professionals and pet keepers 
1. 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 sha ll, in addition to 
notifying the signs or suspicion to the co mpetent authority and veterinarians in 
accordance with Article 16(1) and pending an y disease control measures being taken 
by the competent authority in accordance with Articles 54(1) and 55(1), take the 
appropriate disease control measures provide d for in Article 55(1)(c), (d) and (e) to 
prevent the spread of that listed disease fr om the affected animals, establishments 
and locations under their responsibilit y to other animals or to humans. 
2. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning detailed rules for supplementing the disease control measures to be taken by the operators, animal professi onals and pet keepers as provided for in 
paragraph 1 of this Article. 
Article 54 
Investigation by the competent authority in th e event of suspicion of a listed disease  
1. 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 presen ce of that listed disease. 
2. For the purpose of the investigation pr ovided for in paragraph 1, the competent 
authority shall, when appropriate, en sure that official veterinarians: 
(a) carry out a clinical examination of a representative sample of the kept animals 
of listed species for that pa rticular listed disease;  
(b) 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 c onfirm or rule out th e presence of the 
particular listed disease. EN 80   EN 3. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 253 concerning detailed rules supplem enting the rules for the investigation by 
the competent authority provided for in paragraph 1 of this Article. 
Article 55 
Preliminary disease control measur es by the competent authority  
1. 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 co ntrol 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) the kept animals in the establis hment, household, food and feed business 
or animal by-products establishment, or any other location;  
(ii) the products in the establishmen t, 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 biosecur ity measures to prevent the spreading of that listed 
disease agent to other animals or to humans; 
(d) when appropriate to prevent the furthe r 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 anim als, 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 estab lishments 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 c ontrol measures, taking into account the 
disease control measures provided for in Section 4, concerning:  
(i) the application of the investiga tion by the competent authority provided 
for in Article 54(1) and disease cont rol measures provided for in points 
(a) to (d) of this paragr aph to other establishmen ts, epidemiological units 
therein, households, food and feed businesses or animal by-products establishments;  
(ii) the establishment of temporary re stricted zones, which are appropriate 
taking into account th e disease profile; EN 81   EN (g) initiate the epidemiological enqu iry provided for in Article 57(1); 
2. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning detailed rules suppl ementing 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 referr ed 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 prelim inary disease control measures 
The disease control measures provid ed 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 refe rred to in Article 55(1 )(e), where necessary. 
SECTION 2 
EPIDEMIOLOGICAL ENQUIRY  
Article 57 
Epidemiological enquiry  
1. The competent authority shall carry out an  epidemiological enquiry in event of the 
suspicion or confirmation of a listed disease re ferred to in Article 8(1)(a) in animals. 
2. The epidemiological enquiry provided  for in paragraph 1 shall aim at: 
(a) identifying the likely origin of the li sted disease and the means of its spread; 
(b) calculating the likely length of time that the listed disease has been present; (c) identifying contact establishments and epidemiological units therein, 
households, food and feed business or an imal by-products establishment or any 
other locations where animals of listed sp ecies 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 peri od preceding the notification of the 
suspicion or confirmation of the listed disease; EN 82   EN (e) obtaining information on the likely sp read 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 la boratory 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 a dopt 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 ap ply 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 pursuan t 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 accord ance 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 offi cially infected with that listed disease; EN 83   EN (b) establish a restricted zone, as appropriate for that listed disease; 
(c) implement the contingency plan provide d for in Article 43(1) to ensure full 
coordination of the disease control measures. 
Article 61 
Affected establishmen ts and other locations 
1. In the event of an outbreak of a listed di sease 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, an imals, products, vehicles or any other 
material or substance that may be contam inated and contribute to the spread of 
the listed disease; 
(b) the killing and disposal or slaughtering of animals that may be contaminated 
and contribute to the spread  of the listed disease;  
(c) the destruction, processing, transforma tion 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 ag ent or vector of the dis ease agent is destroyed;  
(d) the vaccination or treatment with othe r veterinary medicina l products of kept 
animals in accordance with Article 46( 1) and any delegated acts adopted 
pursuant to Article 47(1); 
(e) the isolation, quarantine or treatment of  animals and products that are likely to 
be contaminated and contribute to the spread of the listed disease;  
(f) the cleaning, disinfection, disinfes tation or other necessary biosecurity 
measures to be applied to the affected  establishment, household, food or feed 
business, animal by-products establishmen t 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 co ntrol measures provided for in paragraph 1 
are appropriate to take, the competent author ity 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 f eed business, animal by-products 
establishment or other location. EN 84   EN 3. The competent authority shall only author ise the repopulation of the establishment, 
household or any other location when:  
(a) all appropriate disease control measur es and laboratory examinations provided 
for in paragraph 1 have been successfully completed; 
(b) a sufficient period of time has elapse d 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. The competent authority shall extend the disease control measur es provided for in 
Article 61(1) to other establishments, epid emiological 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 i nvestigations or other epidemiological data 
give reason to suspect the spread to, from or through th em of the listed disease 
referred to in Article 8(1)(a) for which such measures were taken. 
2. If the epidemiological enquiry provided fo r 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 spr ead to another Member State, the competent 
authority shall inform that Member State. 
3. In the events referred to in paragraph 2, the competent authorities of the different 
Member States shall cooperate in a furt her epidemiological enquiry and in the 
application of disease control measures. 
Article 63 
Delegating power for the disease control measur es 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 cont rol measures to be taken by the competent 
authority in accordance with Articles 61 and 62 in affected and epidemiologically linked 
establishments, food or feed bus inesses or animal by-products establishments and locations 
for any listed disease referre d to in Article 8(1)(a). 
Those detailed rules shall cover the following matters: 
(a) the conditions and requirements for the disease control measures, provided for in 
Article 61(1)(a) to (e); 
(b) the procedures for cleaning, disinfecti on and disinfestation provided for in of 
Article 61(1)(f), specifying, wh ere appropriate the use of biocidal products for those 
purposes;  EN 85   EN (c) the conditions and requirements for sa mpling and laboratory examination provided 
for in Article 61(1)(g) to (h); 
(d) the detailed conditions and requirement s of repopulation provided for in Article 
61(3); 
(e) the necessary disease control measures prov ided for in Article 62 to be carried out in 
epidemiologically linked establishments, locations and means of transport. 
Article 64 
Establishment of restricted z ones by the competent authority 
1. The competent authority shall establis h a restricted zone around the affected 
establishment, household, food or feed busin ess, 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 fact ors 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 e nquiry 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 protect ion and surveillance 
zone of a defined size and configuration.  
2. The competent authority shall continuously  assess and review the situation and, 
when appropriate in order to prevent the sp read of the listed di sease referred to in 
Article 8(1)(a): 
(a) adapt the boundaries of  the restricted zone; 
(b) establish additional restricted zones. 
3. Where the restricted zones are situated in  the territory of more than one Member 
State, the competent authorities of t hose Member States shall cooperate in 
establishing the restricted zones provided for in paragraph 1.  
4. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning detailed rules for the establishment and amendment of restricted zones, including prot ection or surveillance zones.  EN 86   EN 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 ot her 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 s ubstance 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 distribu tion of products of animal origin;  
(ii) the collection and disposal of animal by-products;  (iii) artificial insemination. 
(e) the vaccination and treatment with othe r 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) the designation or wher e relevant, approval of a food business establishment 
for the purposes of the slaughtering of an imals or the treatment of products of 
animal origin originating from the restricted zones; 
(h) the identification and traceability requi rements for the movement of animals, 
germinal products or products of animal origin; 
(i) other necessary biosecurity and risk m itigating measures to minimise the risks 
of the spread of that listed disease. 
2. The competent authority shall take all nece ssary measures to fully inform the persons 
in the restriction zones of the restrictions in force and the nature of the disease control measures.  
3. When determining which of the disease co ntrol measures provided for in paragraph 1 
are to be taken, the competent authority shall take the following into account:  
(a) the disease profile; EN 87   EN (b) the types of production; 
(c) the feasibility, availability and effectiv eness of those disease control measures.  
Article 66 
Operators obligations in restricted zones 
1. Operators keeping animals and products in the restricted zo ne 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. 
2. 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 di sease referred to in Article 8(1)(a).  
Those detailed rules shall cover the following matters: 
(a) the conditions and requirements for the disease control measures, provided for in 
Article 65(1) (a), (c), (d), (e), (g), (h) and (i); 
(b) the procedures for cleaning, disinf ection and disinfestation provided for 
in Article 65(1)(f), specifying, where appr opriate the use of biocidal products for 
those purposes; 
(c) the necessary surveillance which is to be conducted fo llowing the application of the 
disease control measures and laboratory  examinations provided for in Article 
65(1)(b); 
(d) 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) 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; 
(b) the final cleaning, disinfection or di sinfestation has been carried out as 
appropriate for: EN 88   EN (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 fo r the listed disease referred to in Article 
8(1)(a) for which the disease control meas ures 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 a dopt 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 pa ragraph 1 of this Article in relation to:  
(a) the final cleaning, disinfection or  disinfestation procedures, and where 
appropriate the use of biocid al products for those purposes; 
(b) the design, means, methods, frequency, intensity, targeted animal population 
and sampling patterns of su rveillance to regain disease-free status after the 
outbreak; 
(c) the repopulation of the restricted z ones after the completion of the disease 
control measures provided for in para graph 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 
1. Where relevant for the effective control of  the listed disease referred to in Article 
8(1)(a) for which the disease control m easures due to the outbreak apply, the 
competent authority may:  
(a) develop a vaccination plan; 
(b) establish vaccination zones.  
2. The competent authority shall, when deciding on the vaccination plan and the 
establishment of vaccination zones provided fo r in paragraph 1 of this Article, take 
the following into account: 
(a) the requirements for emergency vaccination provided for in the contingency 
plans provided for in Article 43(1); 
(b) the requirements for the use of vaccin es provided for in Ar ticle 46(1) and any 
delegated acts adopted purs uant to Article 47(1). EN 89   EN 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 c onfirmation of a listed disease referred to in 
Article 8(1)(a) in wild animals, the affected Member State shall: 
(a) conduct, where relevant for that partic ular listed disease, surveillance in the 
wild animal population;  
(b) take the necessary disease prevention a nd control measures to avoid the further 
spread of that listed disease.  
2. The disease prevention and control measur es 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 take n 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 a dopt delegated acts in accordance with 
Article 253 concerning:  
(a) surveillance pursuant to paragraph 1(a);  
(b) disease prevention and control m easures 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. EN 90   EN 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 Memb er States, coordination of measures by the 
Commission and temporary special disease cont rol 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) an d (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 la id down in this Regulation and they are necessary and 
proportionate to control the spr ead of the listed disease refe rred to in Ar ticle 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 th e 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 purs uant to Articles 63 and 67 and Articles 
68(2) and 70(3);  
(b) any additional disease control meas ures taken by it as  provided for in 
paragraph 1. 
3. The Commission shall review the disease si tuation and the disease control measures 
taken by the competent aut hority and any additional dis ease control measures taken 
by the Member State, in accordance with  this Chapter and may, by means of 
implementing acts, lay down special diseas e control measures for a limited period of 
time, under conditions appropriate to th e epidemiological situation, where: 
(a) those disease control measures are found not to be suited to the 
epidemiological situation;  
(b) 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). EN 91   EN 4. On duly justified imperative grounds of urge ncy relating to a disease representing an 
emerging risk of highly significant impact  the Commission shall adopt immediately 
applicable implementing acts in accordan ce 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  
Article 72 
Obligations of operators, animal professionals and pet keepers 
1. In the event of suspicion of listed diseases  referred to in Article 8(1)(b) and (c) in 
kept animals, operators, animal professiona ls 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 an y 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 th eir responsibility to other animals or to 
humans. 
2. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning detailed rules for supplementing the disease control measures to be taken by the operators, animal professi onals and pet keepers as provided for in 
paragraph 1 of this Article. 
Article 73  
Investigation by the competent authority in th e event of suspicion of a listed disease 
1. The competent authority shall, in the ev ent 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. 
2. For the purpose of the investigation pr ovided for in paragraph 1, the competent 
authority shall, when appropriate, en sure that official veterinarians: 
(a) carry out a clinical examination of a representative sample of the kept animals 
of listed species for that pa rticular listed disease;  
(b) take appropriate samples from the ke pt animals of listed species and other 
samples for laboratory examination in laboratories designated for that purpose 
by the competent authority; EN 92   EN (c) carry out a laboratory examination to confirm or rule out the presence of the 
particular listed disease. 
3. The Commission shall be empowered to a dopt 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 measur es by the competent authority  
1. 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 anim als carry out the following preliminary disease 
control measures, pending the results of th e investigation provided for in Article 
73(1) and the carrying out of disease cont rol measures in accord ance with Article 
78(1) and (2): 
(a) apply disease control measures to limit the spread of that listed disease from 
the affected territory, esta blishment, household, food or feed business, animal 
by-products establishment or other location; 
(b) initiate where necessary, an epidemiological enquiry, taking into account the 
rules for such investigation provided for in Article 57(1) a nd 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 lis ted 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) the health status of the Member State, zone, compartment or establishment in 
which that listed disease is suspected; 
(d) the preliminary disease control meas ures provided for in Article 55(1) and 
Article 56 and any delegated act ad opted pursuant to Article 55(2). 
3. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning rules supplementing t hose 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) the preliminary disease control measures  to be taken to prevent the spread of 
the listed disease, as provided for in paragraph 1(a); 
(b) the application of the preliminary di sease control measur es provided for in 
paragraph 1(a) to other establishmen ts, epidemiological units therein, 
households, food or feed businesses and animal by-products establishments or 
other locations; EN 93   EN (c) the establishment of temporary restrict ed zones, which are appropriate due to 
the disease profile. 
Article 75 
Review and extension of the prelim inary disease control measures 
The disease control measures provid ed for in Article 74(1) shall be: 
(a) 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);  
(b) further extended to othe r 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 la boratory 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 a dopt 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 measur es when disease occurrence is ruled out 
The competent authority shall continue to ap ply 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 b een ruled out in accordance with Article 76(1) or rules adopted 
pursuant to Article 76(2). EN 94   EN 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 confirmati on 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) in a Member State, zone or compartm ent subject to a compulsory eradication 
programme provided for in Article 30(1) for that li sted disease, apply the 
disease control measures laid down in that compulsory eradication programme; 
(b) in a Member State, area, zone or co mpartment that is not yet subject to a 
compulsory eradication programme provide d for in Article 30(1) for that listed 
disease, initiate that compulsory erad ication programme and apply the disease 
control measures laid down therein. 
2. In the event of an official confirmati on 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) in a Member State, zone or compartment subject to a voluntary eradication 
programme provided for in Article 30(2) for that li sted disease, apply the 
disease control measures laid down in that voluntary eradication programme; 
(b) in a Member State, area, zone or comp artment that is not subject to a voluntary 
eradication programme provided for in Ar ticle 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 referre d to in Article 8(1)(c) in question taking 
into account: 
(a) the disease profile; (b) the kept animals affected; (c) the health status of the Member State, area, zone, compartment or 
establishment in which the listed disease has been officially confirmed; 
(d) the disease control measures to be taken in the establishments, other locations 
and restricted zones provided for in S ection 4 of Chapter 1 of this Title.  EN 95   EN Article 79 
Delegation of powers for the disease control meas ures to be taken by the competent authority  
The Commission shall be empowered to adopt de legated 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 Arti cle 8(1)(b) or (c) in ke pt animals as provided 
for in Article 78(2)(b) taking into account the criteria pr ovided for in Article 78(3). 
SECTION 4 
WILD ANIMALS  
Article 80 
Wild animals 
1. In the event of suspicion or official c onfirmation of a listed disease referred to in 
Article 8(1)(b) in wild animals, the compet ent authority of the affected Member State 
shall: 
(a) in the entire territory of the Memb er State, area or, zone subject to a 
compulsory eradication programme provide d for in Article 30(1) for that listed 
disease, apply the disease control meas ures laid down in that compulsory 
eradication programme; 
(b) in the entire territory of the Member St ate, area or zone that  is not subject to a 
compulsory eradication programme provide d for in Article 30(1) for that listed 
disease, initiate that compulsory erad ication programme and apply the disease 
control measures laid down therein wh ere appropriate, to control and prevent 
its spread. 
2. In the event of an outbreak of a listed dis ease referred to in Article 8(1)(c) in wild 
animals the competent authority of the affected Member State shall: 
(a) in the entire territory of the Member State, area, zone or compartment subject 
to a voluntary eradication programme pr ovided for in Article 30(2) for that 
listed disease, apply the disease control measures laid down in that voluntary 
eradication programme; 
(b) in the entire territory of the a Member State, area, zone or compartment that is 
not subject to an voluntary eradica tion 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;  EN 96   EN (c) the disease control measures to be take n in the event of suspicion or official 
confirmation of a listed disease in restri cted 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 a dopt delegated acts in accordance with 
Article 253 concerning detailed rules supplem enting 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 Commissi on and temporary special rules concerning 
Sections 1 to 4 
1. Member States shall inform the Commission of the disease control measures taken 
by the competent authority in respect of a lis ted 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 Arti cle 76(2), Article 79 and Article 80(4).  
2. The Commission shall review the disease si tuation 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 ru les 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 th e epidemiological situation, where: 
(a) those disease control measures taken by the competent authority are found not 
to be suited to the epidemiological situation;  
(b) that listed disease referred to in Article 8(1)(b) or (c) appears to be spreading 
despite the disease control measures take n 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 urge ncy relating to a listed disease referred 
to in Article 8(1)(b) and (c) representi ng an emerging risk of highly significant 
impact the Commission shall adopt immedi ately applicable implementing acts in 
accordance with the procedure referred to in Article 255(3). EN 97   EN PART IV 
REGISTRATION, APPROVAL, TRACEABILITY AND 
MOVEMENTS 
TITLE I 
Terrestrial animals, germinal pr oducts 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 terr estrial animals or co llecting, 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 aut hority 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 th e capacity of th e 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 th e establishment concerning th e matters referred to in 
paragraph 1(b); EN 98   EN (b) cessation of activity in the establishment. 
3. Establishments which are subject to appr oval in accordance with Article 89(1) shall 
not be required to provide th e information referred to in paragraph 1 of this Article. 
Article 83 
Derogations from the obligation of oper ators to register establishments  
By way of derogation from Artic le 82(1), Member States may exempt certain categories of 
establishments from the registration requireme nt, taking into account the following criteria: 
(a) the categories, species and numbers of ke pt terrestrial animals and germinal products 
on the establishment and the capacity of the establishment; 
(b) the type of establishment;  (c) the movements of kept terrestrial animal s 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 implemen ting acts, lay down rules concerning: 
(a) the information to be provided by operator s for the purpose of th e registration of the 
establishments as provided  for in Article 82(1); 
(b) 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 an d delegated acts 
1. Transporters of kept ungulates, transpor ting those animals between Member States 
shall in order to be register ed in accordance with Article  88, before they commence 
such activities:  
(a) inform the competent authority of their activity; (b) provide the competent aut hority with information on: 
(i) the name and address of the transporter; (ii) the categories, species and num bers of kept terrestrial animals 
transported; EN 99   EN (iii) the type of transport; 
(iv) the means of transport.  
2. Transporters shall inform th e competent authority of any: 
(a) significant changes concerning the ma tters referred to in paragraph 1(b); 
(b) cessation of the transport activity. 
3. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 253 concerning supplementing a nd amending the rules provided for in 
paragraph 1 concerning the obligation of ot her types of transpor ters to provide the 
information for the purposes of registrati on of its activity, ta king into account the 
risks involved with such transports. 
Article 86 
Derogations from the obligation to re gister transporters of kept ungulates  
By way of derogation from Artic le 85(1), Member States may exempt certain categories of 
transporters from the registration requirement,  taking into account th e following criteria: 
(a) the distances over which they transp ort those kept terrestrial animals;  
(b) the categories, species and number of kept  terrestrial animals, which they transport. 
Article 87 
Implementing acts concerning the ob ligation to register transporters 
The Commission shall be empowered to  adopt implementing acts concerning: 
(a) the information to be provided by the tran sporter for the purposes  of registration of 
its activity, as provided for in Article 85(1); 
(b) 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 th e 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 concerni ng the registration of establishments and 
transporters 
The competent authority shall register:  EN 100   EN (a) establishments in the register of establ ishments and transporters provided for in 
Article 96(1), where the ope rator has provided the information required in 
accordance with Article 82(1); 
(b) 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 establis hments and delegated acts 
1. Operators of the following types of esta blishments shall apply to the competent 
authority for approval in accordance with Ar ticle 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 operati ons 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) hatcheries, from which hatching eggs or poultry are moved to another Member 
State; 
(d) establishments keeping poultry, fro m which poultry intended for purposes 
other than slaughter or hatching eggs are moved to another Member State; 
(e) 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 accord ance with paragraph 3(b) of this 
Article. 
2. Operators shall cease activity at an estab lishment referred to in paragraph 1 where:  
(a) the competent authority withdraws or suspends its approval in accordance with 
Article 95(2); or  
(b) in the event of conditional approval, gr anted 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 fi nal approval in accordance with Article 
92(1).  
3. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 253 concerning supplementing and am ending the rules for the approval of 
establishments provided for in paragr aph 1 of this Article concerning: EN 101   EN (a) derogations from the requirement for ope rators 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; 
(b) the types of establishments which must be approved in accordance with 
paragraph 1(e); 
(c) 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) the categories and species of kept terrest rial animals or germinal products in an 
establishment;  
(b) 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 anim als 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) apply to the competent authority for approval in accordance with Article 91(1); 
(b) 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 es tablishment 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 thei r 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; EN 102   EN (d) the type of establishment; 
(e) other aspects of the establishment, rela ted to its specificit y, 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 implemen ting acts, lay down rules concerning 
the information to be provided by the operato rs in their application for the approval 
of their establishment in accordance w ith 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 a pproval 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) quarantine, isolation and other bios ecurity measures taking into account 
the requirements provided for in Ar ticle 9(1)(b) and rules adopted 
pursuant to Article 9(2);  
(ii) 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 pursuan t to Article 24;  
(iii) record keeping provided for in Arti cles 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 ac count 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; EN 103   EN (e) have a system in place which enable s the operator to demonstrate compliance 
with points (a) to (d) to the competent authority.  
2. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 253 concerning the requirements provi ded 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 re ferred to in paragraph 1(b); 
(d) responsibilities, competence and tr aining 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 th e following matters when establishing the 
rules to be laid down in the delegated act s 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 t ype 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 applica tion made in accordance with Article 89(1) and 
Article 90(a): 
(a) 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;  
(b) for which categories and species of kept terrestrial animals or germinal products of 
those species the approval applies. 
Article 94 
Procedures for granting the approv al by the competent authority   
1. The competent authority shall establish procedures for operators to follow when 
applying for approval of their establishmen ts in accordance with Articles 89(1), 
Article 90 and Article 91(1). EN 104   EN 2. Upon receipt of an application for appr oval from an operator, the competent 
authority shall, in accordance with Article 89(1)(a) and Arti cle 90(a) make an on-site 
visit. 
3. The competent authority may grant conditio nal approval of an establishment where it 
appears, based on the application of the ope rator 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 si gnificant risk, with a view to ensuring 
compliance with all the requirements for appr oval provided for in  Article 92(1) and 
the rules adopted pursuant to Article 92(2).  
4. 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 
1. The competent authority shall keep the approvals of establishments granted in 
accordance with Articles 92 and 94 under review. 
2. 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 ope rator 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 resolv e those deficiencies within a reasonable 
period of time. 
3. Approval shall only be  restored after withdrawal or suspension in accordance with 
paragraph 2 when the competen t authority is satisfied that the establishment fully 
complies with all the requirements of this Regulation appropriate for that type of 
establishment.  EN 105   EN SECTION 3 
REGISTER OF THE COMPETENT AUTHORITY OF ESTABLISHMENTS AND 
TRANSPORTERS  
Article 96 
Establishment and transporter register 
1. The competent authority shall establis h and keep up-to-date a register of:  
(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.  
2. 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. 
3. The Commission shall be empowered to a dopt 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 fo r registers of germinal products establishments, after 
they cease activities;  
(c) public availability of the regist er provided for in paragraph 1. 
4. The Commission may, by means of implementing acts, lay down rules on the format 
of and procedures for the re gister of establishments a nd 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) shal l keep and maintain records containing 
at least the following information: EN 106   EN (a) the species, categories, numbers and iden tification of kept terrestrial animals on 
their establishment; 
(b) the movements of kept terrestrial anim als into and out of their establishment, 
stating as appropriate: 
(i) their place of origin or destination;  (ii) the date of such movements; 
(c) the documents in paper or electr onic form required to accompany kept 
terrestrial animals arriving at or leavi ng 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, trea tments, 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 visi ts required in accordance with Article 23(1) 
and rules adopted pur suant to Article 24. 
2. Establishments which are exempted from the registration requirement in accordance 
with Article 83 may be exempted by the Me mber State from the requirement to keep 
records of the information listed in paragraph 1 of this Article. 
3. Operators of establishments shall keep th e 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 98 
Record keeping for germinal product establishments 
1. Operators of germinal product establishm ents shall keep a nd maintain records 
containing at least the following information: 
(a) the breed, age and identification of donor animals used for the production of 
germinal products; EN 107   EN (b) the time and place of co llection, processing  and storage of germinal products 
collected, produced or processed; 
(c) the identification of the germinal products  together with details of their place of 
destination, if known; 
(d) 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. Establishments which are exempted from the registration requirement in accordance 
with Article 84 may be exempted by the Me mber State from the requirement to keep 
records of the information listed in paragraph 1 of this Article. 
3. The operators of germinal product establis hments 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 k eep 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 disinf estation of the means of transport. 
2. Transporters which are exempted from the registration requirement in accordance 
with Article 86 may be exempted by the Me mber State from the requirement to keep 
records of the information listed in paragraph 1 of this Article. 
3. Transporters shall keep the reco rds provided for in paragraph 1:  
(a) in a manner that they can be made immediately available to the competent 
authority on request.  
(b) for a minimum period to be determin ed by the competent authority, but which 
may not be less than a period of three years. EN 108   EN Article 100 
Delegation of powers concerning record keeping 
1. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning rules supplemen ting 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 trans porters 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) information to be recorded in additi on to that provided fo r in Articles 97(1), 
98(1) and 99(1);  
(c) additional requirements for record k eeping for germinal products collected, 
produced or processed in a germinal products establishment, after they ceased their activities. 
2. The Commission shall take into account th e 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 terre strial animals or germinal products in 
the establishment or transported; 
(c) the type of production on the esta blishment or the type of transport; 
(d) the typical movement patterns of the type of establishment and category of 
animals concerned; 
(e) 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 implemen ting acts, lay down rules concerning:  
(a) the format of records provided for in  Articles 97(1), 98(1) and 99(1) and rules 
adopted pursuant to Article 100; 
(b) electronic keeping of records provided for in Articles 97(1),  98(1) and 99(1) and 
rules adopted pursuan t to Article 100; EN 109   EN (c) procedures for record keeping provided for in Articles 97(1), 98(1) and 99(1) and 
rules adopted pursuan t 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 terrest rial 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) ensures the efficient application of th e disease prevention and control measures 
provided for in this Regulation;  
(b) facilitates the traceability of kept terrestrial animals and their movements 
within and between Member States and their entry into the Union; 
(c) ensures the efficient interoperabilit y, integration and compatibility of the 
elements of that system; 
(d) ensures that the system, to the extent appropriate, is adapted to: EN 110   EN (i) the computerised information syst em 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) 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); 
(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 Artic le 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 author ity or authorise another body or a natural person for 
the practical application of the identifi cation and registration system provided 
for in paragraph 1.  
Article 103 
Member States obligation for establishing a co mputer database of kep t 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 to kept anim als of the porcine species and the 
establishments keeping them; 
(c) the following information related to kept animals of the equine species: 
(i) their unique life number as pr ovided 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 pr ovided for in Article 109(1)(c); 
(iv) the establishments where those animals are habitually kept; EN 111   EN (d) information related to kept terrestrial animals of species other than those 
referred to in (a), (b) a nd (c), when this is provi ded for in rules adopted 
pursuant to paragraph 2. 
2. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 253 concerning the recording of information related to animal species other than those referred to in para graph 1(a),(b) and (c) of th is Article, in the computer 
database provided for in that paragraph where necessary, taking into account the 
risks posed by those species, to: 
(a) ensure the efficient application of th e disease prevention and control measures 
provided for in this Regulation; 
(b) facilitate the traceability of kept terrestrial animal s, their movements within 
and between Member States and their entry into the Union.  
Article 104 
Obligation of the competent authority for id entification documents, movement documents and 
other documents for identifying and tracing kept terrestrial animals 
The competent authority shall issue: 
(a) identification documents for kept terrestrial animals when required by 
Articles 106(b) and 109(c), Arti cle 112(1)(b) and (2)(b), a nd Article 113(b) and rules 
adopted pursuant to Articles 114 and 117; 
(b) movement documents and other documents for identifying and trac ing 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 informa tion on means of identification 
The competent authority shall inform th e Commission and make publicly available 
information on: 
(a) contact points for the computer database s established by the Member States in 
accordance with Article 103(1); 
(b) the authorities or bodies responsible for issuing identi fication documents, movement 
documents and other documents in accordan ce with Article 104, taking into account 
Article 102(4)(c); 
(c) the means of identification that are to be  used for each category and species of kept 
terrestrial animals in acco rdance with Articles 106(a)  and 107(a), Ar ticle 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. EN 112   EN Article 106 
Operators obligations for the identificati on of kept animals of the bovine species 
Operators keeping animals of the bovine species shall: 
(a) ensure that those kept animals are id entified individually by a physical means of 
identification;  
(b) ensure that those kept animals are issu ed with an identification document from the 
competent authority or designated author ity or authorised body, which is a single 
lifetime document and that that document:  
(i) is kept, correctly complete d and updated by the operator; 
(ii) accompanies those kept terrestria l 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 th e ovine and caprine species shall: 
(a) ensure that those kept animals are id entified individually by a physical means of 
identification;  
(b) ensure that those kept animals are ac companied by a correctly completed movement 
document issued by the competent authority  in accordance with Article 104 when 
moved from the establishmen t keeping those animals; 
(c) transmit the information on movements from and into the establishment of those kept 
animals to the computer database provi ded for in Article 103(1) and the rules 
adopted pursuant to Articles 114 and 117.  
Article 108 
Derogations concerning identification documen ts 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 identi fication documents or movement documents 
during movements within the Member State, provided that: 
(a) the information contained in the moveme nt document or identif ication document is 
included in the computer database  provided for in Article 103(1); 
(b) the system for the identification and regist ration 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. EN 113   EN Article 109 
Operators obligations for the identification and registration of  kept animals of the equine 
species 
1. Operators keeping kept animals of the equi ne species shall ensure that those animals 
are individually identified by: 
(a) an unique life number, which is recorded  in the computer da tabase provided for 
in Article 103(1); 
(b) a method which unequivocally links the ke pt 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 id entification and registration of kept l animals of the porcine 
species 
Operators keeping kept animals of the porcine species shall: 
(a) ensure that those kept animals are identif ied by a means of physical identification;  
(b) ensure that those kept animals are ac companied by a correctly completed movement 
document issued by the competent authority in accordance with Article 104(b) when moved from the establishmen t keeping those animals; 
(c) 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 ma y exempt operators from the 
requirement to ensure that kept animals of the porcine species are accompanied by correctly 
completed movement documents issued by the co mpetent authority for movements within the 
Member State, provided that: 
(a) the information on such movement documen ts is included in the computer database 
established by the Member State in accordance with Article 103(1); 
(b) the system for the identification and registration of kept terrestrial animals of the 
porcine species provides an equivalent le vel of traceability as that provided by such 
movement documents. EN 114   EN Article 112 
Pet keepers' obligation for the identification and registration of terr estrial pet animals 
1. Pet keepers shall ensure that terrestrial pe t animals of the species listed in Part A of 
Annex I which are moved from one Memb er 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 Stat e to another Member State, and when 
required by rules adopted pursuan t to Articles 114 and 117, are: 
(a) identified, either i ndividually 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 an imals of species other than those of the bovine, 
ovine, caprine, porcine and equine species an d other than pet animals, comply with the 
following requirements, when required by the rule s adopted pursuant to Articles 114 and 117: 
(a) they are identified, either individually or in groups; (b) they are accompanied by correctly comp leted and updated identification documents, 
movement documents or other documents fo r 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 de legated acts in accordance with Article 253 
concerning: 
(a) the designation of other authorities, the au thorisation 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; EN 115   EN (c) the information to be included in:  
(i) the computer databases pr ovided 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 an imals of the caprine and ovine species 
provided for in Article 107(b); 
(iv) the identification documen t 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) identification documents for terrestrial pet animals provided for in 
Article 112(1)(b) or identification documents, movement documents or other documents for kept terrestrial pet anim als provided for in Article 112(2)(b);  
(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);  
(d) detailed requirements for different species  and categories of kept terrestrial animals 
to ensure the efficient operation of the id entification and regist ration system provided 
for in Article 102(1);  
(e) detailed requirements for kept terrestrial animals entering the Union from third 
countries and territories;  
(f) identification and registration requirement s 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, por cine and equine species wh ere necessary, taking into 
account the risks posed by that species, to: 
(i) ensure the efficient application of th e 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 nece ssary to meet the 
requirements provided for in Article 102(3)(a) and (b);  EN 116   EN (b) when other traceability measures in place in the Member States guarantee that the 
level of traceability of the animal s 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) the categories and species of  kept terrestrial animals; 
(b) the risks involved for those kept terrestrial animals;  (c) the number of animals in the establishment; (d) the type of production in the establishments  where those terrestrial animals are kept;  
(e) movement patterns for the species and cat egories of kept terrestrial animals;  
(f) considerations concerning the protecti on and conservation of species of kept 
terrestrial animals;  
(g) the performance of the othe r traceability elements  of the system for the identification 
and registration of kept terrestrial animals referre d to in Article 102(2). 
Article 117 
Implementing powers concer ning traceability of kep t terrestrial animals 
The Commission shall by means of implementing acts, lay down rules for the implementation 
the requirements provided for in Article s 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, form ats and operational rules of:  
(i) means, methods and the use of identification; (ii) the identification document or move ment 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 doc uments for kept terrestrial animals of 
species; other than of the bovine, ov ine, caprine and equine species 
(v) computer databases. 
(b) the deadlines for:  
(i) the transmission of information by ope rators into the co mputer database;  EN 117   EN (ii) the registration of ke pt terrestrial animals; 
(iii) the identification of kept terrestrial animals and the replacement of 
identification marks; 
(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 germ inal products of kept animals of  the bovine, ovine, caprine, 
equine and porcine species and poultry 
1. Operators producing, processi ng or storing germinal pr oducts shall mark germinal 
products of kept animals of the bovine, capri ne, 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 sh all be designed in such a way as to 
ensure: 
(a) the efficient application of the di sease prevention and control measures 
provided for in this Regulation;  
(b) the traceability of the germinal pr oducts 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 a dopt 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 la id down in Article 118; EN 118   EN (b) traceability requirements for germinal product of kept terr estrial animals of 
species other than of the bovine, caprin e, ovine, equine and porcine species, 
where necessary for:  
(i) the efficient application of the di sease prevention and control measures 
provided for in this Regulation;  
(ii) the traceability of those germinal products, th eir movements within and 
between Member States and their entry into the Union. 
2. The Commission shall take the followi ng matters into account when adopting the 
delegated acts provided for in paragraph 1: 
(a) the species of kept terrestrial an imals 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 ke pt terrestrial animals and 
their germinal products;  
(g) considerations concerning the protecti on 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 implem enting acts, lay down rules concerning:  
(a) technical requirements and specifications for marking provided for in Article 118(1); 
(b) 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).  EN 119   EN 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 th at the movement of 
kept terrestrial animals does not jeopardis e the health status at the place of 
destination with regard to:  
(a) the listed diseases referre d to in Article 8(1)(d);  
(b) emerging diseases. 
2. Operators shall only move kept terrestria l 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 establ ishments 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 adop ted pursuant to Article 114(a) to 
(d) and Article 117. 
Article 122 
Preventive measures in relation to transport 
1. Operators shall take the a ppropriate and necessary preven tive measures to ensure 
that: 
(a) the health status of ke pt 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;  EN 120   EN (c) cleaning, disinfection, disi nfestations of equipment a nd means of transport and 
other adequate biosecurity measures ar e taken, as appropriate to the risks 
involved with the transport. 
2. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning: 
(a) the cleaning, disinfection and disinf estations 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 mortali ties or other disease symptoms with 
an undetermined cause; 
(ii) which is not subject to movement re strictions affecting the species to be 
moved in accordance with the rules laid down in Articles 55(1)(d), 
61(1)(a), Article 62, Articl e 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), Artic le 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 acco rdance with those rules;  
(iii) which is not situated in a restrict ed zone in accordance with rules laid 
down in Article 55(1)(f)(ii), Articl es 64 and 65, Article 74(1), Article 78 
and rules adopted pursuant to Artic le 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 ke pt terrestrial animals subject to movement 
restrictions referred to in point (a)(ii) a nd (iii) or kept terre strial animals of a 
listed species of a lower health status, fo r an adequate period  of time, prior to 
the date of the intended movement to another Member State, thereby 
minimising the possibility of spreadi ng disease, taking into account the 
following matters: EN 121   EN (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 ke pt terrestrial animals moved;  
(iv) other epidemiological factors; 
(c) they comply with the relevant requi rements 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 pl ace 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 slaughter houses receiving kept terrestrial animals 
from another Member State shall:  
(a) check that:  
(i) 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; 
(ii) the identification do cuments provided for in Articles 106(b) and 107(b), 
Article 109(1)(c), Arti cle 113(b) and the rule s adopted pursuant to 
Articles 114 and 117 are present a nd are correctly completed;  
(b) check that the animal health certifi cates 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 referre d 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. EN 122   EN Article 125  
Prohibition on movements of kept terres trial animals between Member States 
Operators shall not move kept terrestrial animal s to another Member State, unless the Member 
State of destination gives expres s authorisation prior to the move ment in the event of animals 
which are intended to be slaughtered for dis ease eradication purpose s as a part of an 
eradication programme provided for in Article 30(1), (2) and (3). 
Article 126 
General requirements for operators for movemen ts of kept terrestrial animals passing 
through Member States but intended for expor t from the Union to third countries or 
territories 
Operators shall ensure that kept  terrestrial animals intended fo r export to a third country or 
territory and passing through the te rritory of another Member Stat e 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 poultr y 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 c onditions as regards the listed 
diseases referred to in Article 8(1)(d): 
(a) they show no clinical symptoms or signs of listed diseases referred to in Article 
8(1)(d) at the tim e of movement; 
(b) they have been subject to a residency period appropriate to those listed diseases 
taking into account the species and categor y of kept ungulates and poutry to be 
moved; 
(c) for a period of time appropr iate 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; 
(d) 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 ungu lates and poultry to other Member States 
1. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 253 concerning: EN 123   EN (a) residency periods provid ed for in Article 127(b); 
(b) the period of time necessary for limiti ng the introduction of kept ungulates or 
poultry into establishments prior to m ovement provided for in Article 127(c); 
(c) supplementary requirements to ensure  that the kept ungul ates 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 amen ding and supplementing the requirements 
laid down in Article 127.  
2. The Commission shall take the following ma tters into account, when establishing the 
rules to be laid down in the delegate d acts provided for in paragraph 1:  
(a) 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;  
(b) the health status as regards listed dis eases referred to in Ar ticle 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 in tended for slaughter 
1. Operators of slaughterhouses receivi ng kept ungulates and poultry from another 
Member State shall slaughter those anim als 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. 
2. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 253 concerning the time of slaughter provided fo r in paragraph 1 of this 
Article. EN 124   EN 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 pa ragraph 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, collec ting kept ungulates and poultry 
directly from their establishments of or igin, 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 ope rations shall ensure that: 
(a) the kept ungulates and poultry assembled are of the same health status or where they 
are not of the same health status, the lowe r health status shall apply to all such 
animals assembled; 
(b) the kept ungulates and poultry are assembled and move d 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 purs uant to Article 132(c);  
(c) the necessary biosecurity measures are ta ken 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;  EN 125   EN (ii) do not pose a significant risk for the spr ead 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 identif ied and, where requir ed, 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 Articl e113(b) and rules ad opted pursuant to 
Articles 114 and 117, unless derogations ar e provided for according to Article 
115;  
(ii) the animal health certificates wh ere provided for in Article 140 and Article 
141(c), unless derogations are provided for in the rules ad opted 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 de legated acts in accordance with Article 253 
concerning: 
(a) specific rules for assembly operations, where other risk mitigating measures, in 
addition to those provided for in Arti cle 131(b) and (c), are in place;  
(b) criteria under which Member States of or igin may allow assembly operations to take 
place on means of transport, as provided for in the second subparagraph of Article 
130(2);  
(c) the timeframe between the time of depart ure of the kept ungul ates or poultry from 
their establishment of origin and their depa rture from the assembly operation to their 
final destination in another Member St ate as referred to in Article 131(b); 
(d) biosecurity measures provi ded 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 ani mals other than kept  ungulates and poultry to other Member 
States and delegated acts 
1. Operators shall only move kept terrestri al 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 spr ead of listed diseases referred to in 
Article 8(1)(d) at the place of destination.  EN 126   EN 2. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 253 concerning detailed rules to ensure  that the kept terr estrial animals other 
than kept ungulates or poultry do not pose a significant risk for the spread of listed 
diseases referred to in Artic le 8(1)(d) provided for in pa ragraph 1 of this Article. 
3. The Commission shall take the following ma tters into account, when establishing the 
detailed rules to be laid down in the de legated acts provided for in paragraph 2:  
(a) the listed diseases referred to in Article 8(1)(d) relevant for the listed species or 
the category of kept terrestri al animals to be moved;  
(b) 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 type s of production at the place of origin and 
the place of destination; 
(d) the types of movement in respect of th e final use of animal s at destination;  
(e) the categories and species of kept terrestrial animals to be moved;  
(f) the age of the kept terres trial animals to be moved; 
(g) other epidemiological factors. 
SECTION 6 
DEROGATING FROM AND SUPPLEMENTING RISK MITIGATION MEASURES  
Article 134 
Animals intended for confined est ablishments 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 destina tion, except where such move ment is authorised for 
scientific purposes. 
2. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 253 concerning: 
(a) detailed rules for movements of kept terrestrial animals into confined 
establishments in addition to those provide d for in paragraph 1 of this Article;  
(b) specific rules for movements of kept  terrestrial animals into confined 
establishments where the risk mitigating measures in place guarantee that such EN 127   EN movements do not pose a significant risk for the health of kept terrestrial 
animals within that confined establis hment and the surrounding establishments. 
Article 135 
Derogations for movements of kept terrestrial  animals for scientific  purposes and delegated 
acts 
1. The competent authority of the place of de stination may, subject to the agreement of 
the competent authority of th e place of origin, authorise mo vements 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. 
2. The competent authorities shall only gran t 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 a nd 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 ta ke place under the supervision of the 
competent authorities of places of orig in and destination, and where relevant, 
the competent authority of the Member State of passage.  
3. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning amending and supplementing the rules for derogations by the competent authorities provided for in pa ragraphs 1 and 2 of this Article.  
Article 136 
Derogations concerning recreational use, s porting 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 th e exception of Article 123(a) and (b) and 
Articles 124 and 125, for intra-Union movement s 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; EN 128   EN (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. Derogations by the competent authority of the place of destination for movements of 
kept terrestrial animals for the purposes provided for in pa ragraph 1 shall be agreed 
on between the Member States of origin  and destination a nd appropriate risk 
mitigating measures taken to ensure that  such movements do not pose a significant 
risk. 
3. The Member States referred to in paragraph 2 shall inform the Commission of the 
granting of derogations provi ded for in paragraph 1.  
4. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 253 concerning amending and supplementing the rules for derogations by the competent authority of the place of destina tion provided for in paragraph 1 of this 
Article. 
Article 137 
Delegation of power concerning derogations fo r 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 ru les laid down in Sections 2 to 5 for the 
movements of kept terrestrial animals for the following purposes:  
(i) circuses, zoos, pet shops, anim al shelters and wholesalers;  
(ii) exhibitions and for sporti ng, cultural and similar events; 
(b) derogations from Sections 2 to 5 with the exception of Arti cle 123(a) and (b) and 
Articles 124 and 125 for the movements of ke pt 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 implementi ng 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, Articl e 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) a nd 129(2), Article 132, Articles 133(2), 134(2), 
135(3) and 136(4) and Article 137 are not e ffectively mitigating the risks posed by 
the movement of such animals; or EN 129   EN (b) the listed disease referred to in Articl e 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 re presenting a risk of 
highly significant impact and taking into accoun t 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 implementi ng acts provided for in Articles 134(2), 135(3) 
and 136(4) and Articles 137 and 138: 
(a) the risks involved with the moveme nts referred to in those provisions;  
(b) the health status as regards the listed di seases referred to in Article 8(1)(d) at the 
places of origin and destination; 
(c) listed animal species for the listed di seases referred to in Article 8(1)(d); 
(d) biosecurity measures in place at the pl aces of origin, destination and en route; 
(e) any specific conditions in establishments under which the kept terrestrial animals are 
kept; 
(f) 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 sp ecies 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; EN 130   EN (b) poultry; 
(c) kept terrestrial animals other than  ungulates and poultry, intended for a 
confined establishment; 
(d) kept terrestrial animals ot her than those referred to in points (a), (b) and (c) of 
this paragraph, when required in acco rdance 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 auth ority of the Member State of origin in 
accordance with Article 146(1), where the co nditions 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 Ar ticle 64(1) and are subject to disease 
control measures provided for in Artic les 55(1), 65(1), 74(1)  or Article 78(1) 
and (2) or rules adopted pursuant to Ar ticle 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 measur es to ensure that the animal health 
certificate referred to in para graph 1 of this Article acco mpanies the kept terrestrial 
animals from their place of origin to thei r final place of destination, unless specific 
measures are provided for in rule s 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 a dopt delegated acts in accordance with 
Article 253 concerning:  
(a) derogations from the animal health cer tification requirements provided for in 
Article 140(1), for movements of kept te rrestrial 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 t ype of production of those species and 
categories of kept terrestrial animals; 
(iii) the intended use of the kept terrestrial animals;  (iv) the place of des tination of the kept te rrestrial animals; or EN 131   EN (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 competen t authority, taking into account the 
matters provided for in paragraph 2 of this Article, which ensure: 
(i) the traceability of the kept te rrestrial 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 cer tification for movements of species and 
categories of kept terrestrial animal s 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 pr ovided for in Sections 1 to 6.  
2. When establishing the special rules provide d for in paragraph 1( b), the Commission 
shall take the following matters into account: 
(a) the confidence of the competent author ity about the biosecurity put in place by 
operators as provided for in Article 9(1)(b) and rules adopted pursuant 
Article 9(2); 
(b) the capability of the competent aut hority to take necessary and appropriate 
measures and activities required by this Regulation as provided for in Article 
12(1); 
(c) the level of obtained basic knowledge of animal health as provided for in 
Article 10 and the support prov ided for in Article 12(2); 
(d) the performance of the animal health visits as provided for in Article 23 and 
rules adopted pursuant to Article 24, wher e other relevant su rveillance, quality 
assurance schemes or official  controls as referred to in Article 23(1)(c) are not 
in place; 
(e) the performance of the Union notifi cation and reporting as provided for in 
Articles 17 to 20 and the rules adopted pur suant to Articles 17(3) and18(3) and 
Article 21 applied by the competent authority;  
(f) 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 referre d 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. EN 132   EN 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 a ssembly 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 regi stration of kept terrestrial animals, where required by 
Articles 106, 107, 109, 110 and 113 and rule s 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 th e kept terrestrial 
animals comply with the relevant anim al health requirements for movements 
provided for in Sections 1 to 6. 
2. The animal health certificate may incl ude other information required under other 
Union legislation. 
Article 143 
Delegation of powers and impl ementing acts concerning the contents of animal health 
certificates  
1. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning: 
(a) detailed rules on the content of anim al health certificates provided for in 
Article 142(1) for different categories a nd species of kept terrestrial animals 
and for specific types of movements pr ovided 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 implem enting acts, lay down rules for model 
forms of animal health certificates. Thos e implementing acts shall be adopted in 
accordance with the examination proce dure 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 de legated acts in accordance with Article 253 
concerning specific measures supplementing the obligation of operators to ensure that animals are accompanied by an animal health certifi cate provided for in Article 140 and the rules EN 133   EN adopted pursuant to Article 141 for the followi ng types of movements of kept terrestrial 
animals: 
(a) movements of kept ungulates and poultr y passing through the assembly operations 
provided for in Article 130 prior to r eaching their final pl ace of destination; 
(b) movements of kept terrestr ial 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 in terrupted for animal welfare reasons;  
(ii) unpredicted accidents or events en route;  (iii) the kept terrestrial animals were re jected at the place of destination in a 
Member State or at the exte rnal border of the Union; 
(iv) the kept terrestrial anim als were rejected at a place of assembly or resting;  
(v) the kept terrestrial animals we re rejected in a third country;  
(c) movements of kept terrestrial animals intended for exhibition s 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) provide the competent aut hority 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;  
(b) where necessary, subject the kept terrest rial animals to documentary, identity and 
physical checks as provided for in Article 146(3). 
Article 146 
Competent authority responsibility for animal health certification  
1. The competent authority shall, upon request  by the operator issue an animal health 
certificate for the movement of kept terres trial 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 th e 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 134   EN (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 implementi ng 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 ke pt terrestrial animals covered by it, 
continue to comply with the animal health guarantees contained in it.  
3. The official veterinarian sha ll, 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. 
4. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 laying down rules for:  
(a) the types of documentary, identity a nd physical checks for different species and 
categories of kept terrestrial animals that must be carried out by the official veterinarian in accordance with paragr aph 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 ce rtificates by the official veterinarian 
prior to the movement of consignmen ts of kept terre strial animals; 
(c) the duration of the validity of animal hea lth 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) such electronic animal health certificates  contain all the information that the model 
form of animal health certificate is require d to contain in accordance with Article 142 
and rules adopted pursu ant to Article 143;  
(b) 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 135   EN to their place of destination in another Me mber State and ensure that it accompanies 
such animals, where they are not required to be accompanied by an animal health certificate provided for in Ar ticle 140(1) and (2).  
2. The self-declaration document provided for in paragraph 1 shall contain the 
following information concerning th e kept terrestrial animals: 
(a) their place of origin, their place of des tination and when relevant any places of 
assembly or rest;  
(b) a description of the kept terrestria l animals, their species, category and 
quantity; 
(c) identification and registration where required in accordance with Articles 106, 
107, 109 and 110, and Article 113(a) and ru les adopted pursuant to Articles 
114 and 117; 
(d) information needed to demonstrate that the kept terrestrial animals comply with 
the animal health requirements for move ments provided for in Sections 1 to 6. 
3. The Commission shall be empowered to a dopt 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  categories and species of animals;  
(b) information to be contained in the se lf-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 provi ded 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 concerni ng the notificatio n 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 terre strial 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 pur suant to Article 146(4); EN 136   EN (b) the animals must be accompanied by an an imal health certificate for kept terrestrial 
animals where they are being moved from a restricted zone and are subject to disease control measures as refe rred to in Article 140(2); 
(c) 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 acco rdance with Article 150(1). 
Article 150 
Competent authority responsibility for notificat ion of movements to other Member States 
1. The competent authority of the Member St ate 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. 
2. The notification referred to in paragraph 1 shall be carried out, whenever possible, 
through IMSOC. 
3. Member States shall designate regions for the management of notifications of 
movements as provided for in paragraph 1. 
4. By way of derogation from paragraph 1, the competent authority of the Member 
State of origin may authorise the opera tor to notify partially or completely 
movements of kept terrestrial animals th rough 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 a dopt delegated acts in accordance with 
Article 253 concerning:  
(a) the requirement for advance notifica tion by operators of movement of kept 
terrestrial animals between Member Stat es 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;  
(b) the information necessary to notify movements of kept terrestrial animals as 
provided for in Articles 149 and 150; 
(c) the emergency procedures for the notific ation of movements of  kept terrestrial 
animals in the case of power cuts and other disturbances of IMSOC; EN 137   EN (d) the requirements for the designation of regions by Member States for the 
management of notification of moveme nts provided for in Article 150(3). 
2. The Commission may, by means of implem enting acts lay down rules concerning:  
(a) the format of notifica tions of movements of kept  terrestrial animals by:  
(i) operators to the competent authority of their Member St ate of origin in 
accordance with Article 149; 
(ii) the competent authority of the Me mber State of origin to the Member 
State of destination in ac cordance with Article 150; 
(b) the deadlines for:  
(i) the necessary information referred to in Article 149 to be provided by the 
operator to the competent authority of the Member State of origin;  
(ii) the notification of movements of movements of kept terrestrial animals 
by the competent authority of the Memb er 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 pe t animals and delegated and implementing acts 
1. Pet keepers shall only carry out non-commerc ial movements of terrestrial pet animals 
of the species listed in A nnex I from one Member Stat e to another Member State 
where: 
(a) 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;  
(b) appropriate prevention a nd 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 a dopt delegated acts in accordance with 
Article 253 concerning the prevention and di sease 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 re ferred to in Article 8(1)(d) and emerging EN 138   EN diseases to animals during transport and at the place of destination and when relevant 
taking into account the health st atus of the place of destination. 
3. The Commission may, by means of implem enting acts lay down rules concerning the 
prevention and disease control measures provi ded 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 fr om a habitat in one Member State to a 
habitat or to an establishment in another Member State where:  
(a) 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 emergi ng diseases en route or at the place of 
destination; 
(b) the wild animals do not come from a ha bitat in a restricted zone subject to 
movement restrictions due to the occurre nce 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 adopt ed pursuant to Articles 
70(3)(b) and Articles71(3), 80(4) and Ar ticle 81(3) or the emergency measures 
provided for in Articles 245 and 246 and ru les adopted pursuant  to Article 248 
unless derogations have been grante d in accordance to those rules;  
(c) the wild animals are accompanied by an animal health certificate or other 
documents where animal health certifica tion is necessary to ensure compliance 
with the animal health requirements fo r movements provided for in points (a) 
and (b) of this paragraph and the rule s adopted pursuant to Article 154(1)(c) 
and (d) are complied with;  
(d) the movement is notified by the compet ent authority of the Member State of 
origin to the competent authority of th e Member State of destination, when 
animal health certificate is required by the rules adopted pursuant to Article 
154(1)(c) . 
2. When animal health certific ation is required by the rules adopted pursuant to Article 
154(1)(c) the requirements pr ovided 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 moveme nts of wild terr estrial animals. 
3. When notification of movements is require d in accordance with paragraph 1(d) of 
this Article, the requirements provided fo r in Articles 149, 150 and the rules adopted EN 139   EN pursuant to delegated acts laid down in Arti cle 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 a dopt delegated acts in accordance with 
Article 253 concerning: 
(a) the animal health requirements for movements of wild terrestrial animals 
provided for in Article 153(1)(a) and (b); 
(b) the animal health requirements for th e introduction of wild terrestrial animals 
when moved from the wild: 
(i) into establishments;  (ii) for keeping as pet animals;  
(c) 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 requi rements concerning the contents of 
such certificates or other documents;  
(d) the notification by the competent authority of the Member State of origin to the 
competent authority of the Member St ate of destination in the case of 
movements of wild terrestrial anim als between Member States and the 
information to be included in such notification. 
2. The Commission may, by means of implemen ting 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 cert ificates and other documents which are 
required to accompany movements of th e wild terrestrial  animals, when 
provided for in delegated acts adop ted pursuant to paragraph 1(c); 
(b) the format of the notification by the competent authority of the Member State 
of origin and the deadline s 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).  EN 140   EN Chapter 6 
Movements within the Union of germinal products  
SECTION 1 
GENERAL REQUIREMENTS  
Article 155 
General requirements for movem ent of germinal products  
1. Operators shall take appropriate preventive measures to ensure th at the movement of 
germinal products does not jeopardise the heal th status of kept terrestrial animals at 
the place of destina tion with regard to: 
(a) the listed diseases referred to in Article 8(1)(d); (b) emerging diseases. 
2. Operators shall only move germinal produc ts 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 establ ishments 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. Operators shall comply with the requireme nts of Article 122 fo r the transport of 
germinal products of kept terrestrial animals. 
4. Operators shall not move germinal produc ts 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 destr oyed for disease eradication 
purposes as a part of an er adication programme provided fo r in Article 30(1) or (2). EN 141   EN Article 156  
Obligations for operators at  the place of destination 
1. Operators of establishments at the place of destination receiv ing 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 cer tificates 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 supervisi on 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 germi nal products of kept ani mals of the bovine, 
ovine, caprine, porcine and equine species  and of poultry to other Member States 
1. Operators shall only move germinal produc ts 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) they are collected, produced, proce ssed and stored in germinal product 
establishments approved for that purpose in accordance with Article 92(1) and 
Article 94;  
(b) they fulfil the traceability requirements for the type of germinal product in 
accordance with Article 118 and rules adopted pursuant to Article 119; 
(c) they have been collected from th e donor animals which comply with the 
necessary animal health requirements to  ensure that the germinal products do 
not spread listed diseases;  EN 142   EN (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 re strictions affecting the listed species in 
accordance with:  
(a) Article 55(1)(a), (c), (e) and Artic le 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) rules adopted pursuant to Article 55 (2), Articles 63 and 67, Articles 71(3) 
and74(3), Article 79 and Article 81(2); and  
(c) 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 ani mals 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 fo r movements of germinal products of kept 
animals of the bovine, ovine, caprine, porcine and equine species an d of poultry to other 
Member States provided for in Article 157, specifying: 
(a) rules for the collection, production, processing and storag e of germinal products of 
those kept animals in approved establishments  as referred to in Article 157(1)(a);  
(b) animal health requirements pr ovided for in Artic le 157(1)(c):  
(i) for kept animals from which germinal products were collected;  (ii) isolation or quarantine for the ke pt donor animals referred to in (i); 
(c) laboratory and other tests on kept donor animals and germinal products;  
(d) animal health requirements for the colle ction, production, proc essing, storage or 
other procedures and transport pr ovided for in Article 157(1)(d); 
(e) derogations for operators from the rule s provided for in Artic le 157, taking into 
account the risks of such germinal products  and any risk mitigating measures in 
place. EN 143   EN SECTION 3 
ANIMAL HEALTH CERTIFICATION AND NOTIFICATION OF MOVEMENTS  
Article 159 
Operators' obligations concerning animal heal th 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 produc ts 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 comp etent authority of the Member State of 
origin in accordance with para graph 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 anim als 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 Articl e 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 accordan ce with the rules referred in this 
point; and 
(ii) the germinal products of kept an imals are of species subject to those 
disease control or emergency meas ures referred in point (i). 
2. Operators shall take all necessary measur es to ensure that the animal health 
certificate referred to in paragraph 1 accomp anies the germinal products from their 
place of origin to their place of destination. 
3. 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. 
4. Articles 142, 145, 146 and 147 and the rules adopted pursuant to Articles 143 and 
144 and Article 146(4), shall apply to the anim al 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.  
5. The Commission shall be empowered to a dopt 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: EN 144   EN (a) the nature of the germinal products or the species of animal that those products 
come from;  
(b) the methods of production and pr ocessing at the germinal product 
establishment; 
(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 germ inal product establishment. 
Article 160 
Content of animal he alth 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 an d the species of kept donor animals;  
(c) the volume of the germinal products; (d) the marking of the germinal products , when required by Articles 118(1) and by 
rules adopted pursuant to Article 119(1);  
(e) information needed to demonstrat e 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 pursu ant to Article 158. 
2. The animal health certificate for the germinal products provided for in Article 159 
may include other information requi red under other Union legislation.  
3. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning: 
(a) the information to be contained in the animal health certificate pursuant to 
paragraph 1 of this Article; 
(b) animal health certification for diffe rent types of germinal products and of 
different animal species.  
4. The Commission may, by means of implemen ting 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).  EN 145   EN Article 161 
Notification of movements of germinal products of  kept animals of the bovine, ovine, caprine, 
porcine and equine species and of po ultry to other Member States 
1. Operators shall:  
(a) inform the competent authority in thei r Member State of origin in advance of 
the intended movement of germinal produc ts of kept animals of the bovine, 
ovine, caprine, porcine and equine speci es and of poultry to another Member 
State when:  
(i) the germinal products are required to be accompanied by an animal 
health certificate in accord ance with Article 159(1); 
(ii) notification of move ment is required in accord ance 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 m ovement of the germinal products to the 
competent authority of the Member Stat e of destination in accordance with 
paragraph 2. 
2. The competent authority of the Member St ate of origin shall notify the competent 
authority of the Member State of destina tion 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 a dopted pursuant to Article 151. 
3. Articles 149 and 150 and rules adopted pursuant to Article 151 shall be applicable to 
the notification of germinal products. 
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 terres trial animals other than those of  the bovine, ovine, caprine, 
porcine and equine species and of poultry 
1. Operators shall only move germinal products  of kept terrestrial  animals of species 
other than those of the bovine, ovine, capri ne, 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.  
2. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 253 concerning animal health require ments, animal health certification and 
notification requirements for movements of germinal products of  kept terrestrial EN 146   EN animals of species other than  those of the bovine, ovine, ca prine, porcine and equine 
species and of poultry taking into  account the following matters: 
(a) listed diseases referred to in Ar ticle 8(1)(d) for the listed species;  
(b) the species of animals from which th e 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 Articl es 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 scie ntific purposes and delegated acts 
1. By way of derogation from Sections 1 to 4, the competent author ity of the place of 
destination may authorise movements of ge rminal 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), Artic le 155(3) and Artic le156, 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 he alth 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 pr oducts take place under the supervision of 
the competent authority of  the place of destination. 
2. When granting a derogation in accordance w ith paragraph 1, the competent authority 
of the place of destin ation shall notify the Member Stat es of origin and the Member 
States of passage of the derogation gr anted and the conditions under which it has 
been granted.  EN 147   EN 3. The Commission shall be empowered to a dopt 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 dist ribution within the Union of 
products of animal origin  
Article 164 
General animal health obligations  for operators and delegated acts 
1. Operators shall take appropria te preventive measures to ensu re that at all stages of 
the production, processing and di stribution of products of anim al 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. 
2. Operators shall ensure that products  of animal origin do not come from 
establishments or food business establishmen ts 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 ru les adopted pursuant to Article 248; 
(b) movement restrictions applicable to kept terrestrial animals and products of 
animal origin, as provided for in Artic les 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 ru les 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 move ment restrictions are provided for in 
those rules. 
3. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 253 concerning detailed requi rements 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 Articl e 8(1)(d) and species concerned by it and  
(b) the risks involved. EN 148   EN Article 165 
Animal health certificates obligat ions on operators and delegated acts 
1. Operators shall only move the following pr oducts of animal origin within a Member 
State or to another Member State where th ey 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 re stricted 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 restri cted zone subject to disease control 
measures in accordance with Article 31(1), Article 55(1)(f)(ii), Article 
56, Article 61(1)(a), Artic le 62(1), Article 64, Artic les 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. Operators shall take all necessary measur es to ensure that the animal health 
certificate referred to in paragraph 1 accompan ies the products of animal origin from 
their place of origin to their place of destination. 
3. 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. 
4. Articles 145, 146 and 147 and the rules adopt ed pursuant to Articles 143 and144 and 
Article 146(4) shall apply to the animal h ealth certification of the movements of the 
products of animal origin referred to in paragraph 1 of this Article.  
5. The Commission shall be empowered to a dopt 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.  EN 149   EN Article 166 
Content of animal health certifica tes and delegated and implementing acts 
1. The animal health certifi cate for products of animal or igin provided for in Article 
165(1) shall contain at least the following information:  
(a) the establishment or place of orig in and the establishment or place of 
destination; 
(b) a description of the products of animal origin;  (c) the quantity of the pr oducts of animal origin; 
(d) the identification of the products of animal origin, when required by Article 65 
(1)(h) or rules adopted purs uant to Article 67(a); 
(e) information needed to demonstrate that the products of animal origin comply 
with the movement restriction requireme nts provided for in Article 164(2) and 
rules adopted pursuant to Article 164(3). 
2. The animal health certificate for products of animal origin referred to in paragraph 1 
may include other information requi red under other Union legislation.  
3. The Commission shall be empowered to a dopt 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. 
4. The Commission may, by means of implemen ting acts, lay down rules concerning 
model forms of animal health certificates for products of an imal origin referred to in 
paragraph 1 of this Article. Those implem enting 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) inform the competent authority in thei r Member State of origin in advance of 
the intended movement of the produc ts of animal origin when the 
consignments are required to be accompanie d by an animal health certificate in 
accordance with Article 165(1); 
(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 destin ation in accordance with paragraph 2. 
2. The competent authority of the Member St ate of origin shall notify the competent 
authority of the Member State of destina tion of movements of products of animal 
origin in accordance with Article 150 and the rules adopted pursuant to Article 151. 
3. Articles 149 and 150 and rules adopted pursuant to Article 151 shall be applicable to 
the notification of products of animal origin. EN 150   EN Chapter 8 
Scope of national measures 
Article 168 
National measures concerning movements of animals and germinal products  
1. Member States shall remain free to take  national measures concerning the movement 
of kept terrestrial animals and germinal pr oducts thereof within their own territories. 
2. 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 a ppropriate 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 const itutes a significant risk for the animal health 
situation of kept terrestrial an imals in a Member State, the Member State concerned may take 
national measures to control that dis ease, provided those measures do not: 
(a) hinder the movement of animals a nd products between Member States;  
(b) exceed the limits of what is appropriat e and necessary to control that disease. EN 151   EN 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 regist er aquaculture establishments  
1. Operators of aquaculture establishments shal l, in order to be registered in accordance 
with Article 171, before they commence such activities:  
(a) inform the competent authority of any aquaculture esta blishment under their 
responsibility; 
(b) provide the competent aut hority 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 nu mbers of aquaculture animals on the 
aquaculture establishment and the capacity of the aquaculture establishment; 
(iv) the type of aqu aculture establishment; 
(v) other aspects of the establishment which are relevant in determining the 
risk posed by it.  
2. Operators of aquaculture establishments re ferred 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 subj ect to approval in accordance with Article 
174(1) shall not be required to provide the information re ferred to in paragraph 1 of 
this Article. EN 152   EN 4. An operator may apply for a registration pr ovided for in paragraph 1 to cover a group 
of aquaculture establishments provided th at 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 responsibi lity 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 Articl e and Article 171(2) and the rules adopted 
pursuant to Article 173, whic h are applicable to a singl e aquaculture establishment 
shall be applicable to the whole gr oup of aquacultur e establishments. 
Article 171  
Obligations of the competent authority c oncerning the registration of aquaculture 
establishments 
The competent authority shall register:  
(a) aquaculture establishments in the register  of aquaculture estab lishments provided for 
in Article 183(1), where the operator ha s provided the information required in 
accordance with Article 170(1); 
(b) groups of aquaculture establishment in th at register of aquaculture establishments 
provided that the criteria laid down in Article 170(4) are complied with. 
Article 172 
Derogations from the obligation of operato rs to register aquacultu re establishments  
By way of derogation from Artic le 170(1), Member States may exempt certain categories of 
aquaculture establishments from the regist ration requirement taking into account the 
following criteria: 
(a) the categories, species and number or  volume of aquaculture animals on the 
aquaculture establishment and the capac ity of the aquaculture establishment; 
(b) the type of aquaculture establishment;  (c) the movements of aquaculture animals into and out of the aquaculture establishment.  
Article 173 
Implementing powers concerning derogations from the obliga tion to register aquaculture 
establishments 
The Commission may, by means of implem enting acts lay down rules concerning: EN 153   EN (a) the information to be provided by operator s for the purpose of th e registration of the 
aquaculture establishment as provided for in Article 170(1);  
(b) the types of aquaculture establishments for which the derogations from the 
registration requirement may be granted by Me mber 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 es tablishments and delegated acts 
1. Operators of the following types of aquacu lture establishments shall apply to the 
competent authority for approval in accord ance 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 aquacultu re 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 consump tion of small quanti ties to the final 
consumer; or  
(ii) to local retail establishments directly supplying th e final consumer. 
(b) other aquaculture establishmen ts which pose a high risk due to: 
(i) the categories, species and num ber of aquaculture animals on the 
aquaculture establishment;  
(ii) the type of aqu aculture 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) the competent authority withdraws or suspends its approval in accordance with 
Article 182(2); or  
(b) in the event of conditional approval, gr anted in accordance with Article 181(3), 
the aquaculture establishment fails to comply with the outstanding EN 154   EN 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 a dopt delegated acts in  accordance with 
Article 253 concerning supplementing and am ending the rules for the approval of 
aquaculture establishments provided for in paragraph 1 of this Article concerning: 
(a) derogations from the requirement fo r operators to apply to the competent 
authority for approval of the types of aqu aculture 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 establ ishment and the type of production; 
(c) typical movement patterns of the type of aquaculture  establishment and 
concerned species or categor y of aquaculture animals. 
5. An operator may apply for an approval of group of aquaculture establishments 
provided that the requirements provided fo r 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 ope rators operate under a 
common biosecurity system; however, disp atch centres, purification centres and 
similar establishments located inside such  an epidemiologically linked area must be 
approved individually;  
(b) they are under the responsibi lity 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 th e rules adopted pursuan t to Articles 178(2) 
and 179(2) which are applicable to a single aquaculture  establishment shall be applicable to 
the group of aquaculture establishments. EN 155   EN Article 176 
Approval of status of confin ed aquaculture establishments 
Operators of aquaculture establishments, wh o want to obtain the status of confined 
establishment shall: 
(a) apply to the competent authority for approval in accordance with Article 178(1); 
(b) not move aquaculture animals to a confined aquaculture establishment in accordance 
with the requirements  provided for in Article 203(1) an d any delegated acts adopted in 
accordance with Article 203(2) until their es tablishment obtains an approval of that 
status by the competent authority in acco rdance with Article 179 or Article 181.  
Article 177 
Approval of disease contro l aquatic food establishments 
Operators of disease control aquatic food establis hments shall ensure that  their esta blishments 
are approved by the competent authority to sl aughter aquatic animals for disease control 
purposes in accordance with Articl e 61(1)(b), Article 62 and Artic les 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 thei r 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 numbe rs of aquaculture animals on the 
establishment; 
(d) the type of establishment; (e) where relevant, the details of th e approval of a group of aquaculture 
establishments in accordance with Article 175; 
(f) other aspects of the aquaculture es tablishment, 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. EN 156   EN 3. The Commission may, by means of implemen ting 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 acc ordance with the ex amination procedure 
referred to in Article 255(2). 
Article 179 
Granting of approval and conditions  for approval and delegated acts 
1. 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 contro l aquatic food establishments referred to 
in Article 177 where such establishments: 
(a) comply with the following requirements, where appropriate on:  
(i) quarantine, isolation and other bios ecurity measures taking into account 
the requirements provided for in Ar ticle 9(1)(b) and rules adopted 
pursuant to Article 9(2);  
(ii) surveillance requirements provided for in Article 22 and where relevant 
for the type of establishment and th e risk involved, in Article 23, and the 
rules adopted pursuan t to Article 24;  
(iii) record keeping provided for in Ar ticles 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 ac count the type of establishment; 
(ii) of adequate capacity for th e quantity of aquatic animals; 
(c) do not lead to an unacceptable risk fo r 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 requirement s laid down in points (a), (b) and (c) 
are fulfilled.  
2. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 253 concerning the requirements provi ded for in paragraph 1 of this Article 
as regards: 
(a) quarantine, isolation and other bi osecurity measures referred to in 
paragraph 1(a)(i);  
(b) surveillance referred to in paragraph 1(a)(ii); (c) facilities and equipment refe rred to in paragraph 1(b).  EN 157   EN 3. The Commission shall take into account th e following matters when establishing the 
rules to be laid down in the delegated act s 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 e xpressly specify in approvals of  aquaculture establishment or 
a disease control aquatic food establishm ent granted pursuant to Article 179(1): 
(a) for which of the types of aquaculture es tablishments referred to in Article 174(1), 
Article 176(a), groups of aquaculture estab lishments referred to in Article 175 and 
disease control aquatic food establishmen ts referred to in Article 177, and rules 
adopted pursuant to Article 174( 3)(b) the approval applies; 
(b) for which species and categories of a quaculture animals the approval applies. 
Article 181 
Procedures for granting the approv al by the competent authority   
1. The competent authority shall establish procedures for operators to follow when 
applying for approval of their establishm ents in accordance with Article 174(1) and 
Articles 176 and 177. 
2. 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. 
3. The competent authority may grant conditio nal approval of an establishment where it 
appears, based on the application of the ope rator 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 si gnificant risk, with a view to ensuring 
the compliance with the out standing requirements for a pproval provided for in 
Article 179(1) and the rules adop ted pursuant to Article 179(2).  
4. 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 gr anting conditional approval, that the establishment meets 
all the requirements for approval provided fo r in Article 179(1) and the rules adopted 
pursuant to Article 179(2).  EN 158   EN 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 182 
Review, suspension and withdrawal of appr ovals by the competent authority  
1. The competent authority shall keep the approvals of establishments granted in 
accordance with Articl e 179(1) under review. 
2. Where the competent authority identifies serious deficiencies in the establishment as 
regards compliance with the requirements la id down in Article 179(1) and the rules 
adopted pursuant to Article 179(2) and the ope rator 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. 
3. Approval shall only be restor ed after withdrawal or su spension in accordance with 
paragraph 2 when the competent authority is satisfied that the establishment fully complies with all the requireme nts of this Regulation, appr opriate 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 establis h and keep up–to-date  a register of:  
(a) all aquaculture establishments regi stered in accordance with Article 171; 
(b) all aquaculture establishments approved in accordance with Articles 179(1);  (c) all disease control aquatic food esta blishments 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 ope rator and its registration number; 
(b) the geographical position of the aquaculture establishment or when applicable, 
the group of aquaculture establishments; EN 159   EN (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. For establishments approved in accord ance 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. 
4. Where appropriate and relevant, the competent authority may combine the 
registration provided for in  paragraph 1 with regist ration for other purposes. 
Article 184 
Delegation of powers and impl ementing acts concerning th e register of aquaculture 
establishments 
1. The Commission shall be empowered to a dopt 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 th at 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 es tablishments 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 AN D TRACEABILITY  
Article 185  
Record keeping obligations of operators of aquaculture establishments  
1. Operators of aquaculture establishments s ubject 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: EN 160   EN (i) their place of origin or destination;  
(ii) the date of such movements; 
(b) the animal health cer tificates in paper or el ectronic form required to 
accompany movements of aquaculture an imals arriving at the aquaculture 
establishment in accordan ce 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 releva nt for the type of production;  
(d) biosecurity measures, surveillance, trea tments, test results and other relevant 
information as appropriate for:  
(i) the category and species of the aqua culture 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 su ch a way that the 
tracing of the place of origin and de stination 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 f ood establishments subject to approval in 
accordance with Article 177 sh all 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 a quatic food establishments shall: 
(a) keep the records provided for in pa ragraph 1 on the disease control aquatic 
food establishment and make them avai lable to the competent authority on 
request; EN 161   EN (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) aquaculture establishments and dis ease control aquatic food establishments 
visited by the means of transport;  
(c) any exchange of water that took place during trans port, specifying the sources 
of new water and sites of release of water. 
2. Transporters shall: 
(a) keep the records provided for in paragraph 1 and make them available to the 
competent authority on request; 
(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 188 
Delegation of powers concerning record keeping 
1. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning rules supplemen ting 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 keep ing a small number of animals or 
transporters transporting a small number of animals; 
(iii) certain categories or species of animals; 
(b) information to be recorded by operato rs in addition to that provided for in 
Articles 185(1), 186(1) and 187(1); 
(c) the minimum period of time during whic h records provided for in Articles 185, 
186 and 187 are required must be kept. EN 162   EN 2. The Commission shall take the followi ng 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 aq uaculture animals on the aquaculture 
establishment; 
(c) the type of production of the establishment; (d) typical movement patterns for the type of aquaculture establishment or disease 
control aquatic food establishment; 
(e) 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 implemen ting acts, lay down rules concerning: 
(a) the format of records to be kept in  accordance with Articles 185, 186 and 187; 
(b) electronic keeping of those records; (c) 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 aq uatic animals other than aquatic 
pet animals 
SECTION 1  
GENERAL REQUIREMENTS  
Article 190  
General requirements for movement of aquatic animals  
1. Operators shall take appropr iate measures to ensure th at the movement of aquatic 
animals does not jeopardise the health status at the place of des tination with regard 
to:  
(a) the listed diseases referre d to in Article 8(1)(d);  
(b) emerging diseases. EN 163   EN 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, Artic le 70(1) and (2), Article s 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 dow n in Articles 244 an d 247 and the rules 
adopted pursuant to Article 248. 
However, operators may move those a quatic 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 orig in, are consigned without de lay to the final place of 
destination. 
Article 191 
Disease preventive measures in rela tion 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 animal s is not jeopardised during transport; 
(b) transport operations of aquatic anim als 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; 
(c) cleaning, disinfection and disinfestations of equipmen t and means of transport 
and other adequate biosecurity measures are taken, as appropriate to the risks 
involved with the transport; 
(d) any exchanges of water during the tran sport 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 a dopt delegated acts in accordance with 
Article 253 concerning: EN 164   EN (a) the cleaning, disinfection and disinf estations 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 measur es 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 destru ction 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) a nd 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), Arti cles 63 and 66, Articles 70(3), 71(3) and 
74(3), Article 79, and Ar ticles 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 consumpti on, aquaculture, release into the wild or 
any other specific purpose, shall not be us ed for any purpose other than the intended 
one.  
Article 193 
Obligations for operators at  the place of destination 
1. Operators of establishments and food bus iness establishments receiving aquaculture 
animals shall:  
(a) check that one of the following documents are present: 
(i) the animal health certificates pr ovided for in Article 208(1), Article 209 
and Article224(1) and th e rules adopted pursuant to Articles 188, 211 and 
213 are present;  
(ii) the self-declaration documents pr ovided 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 re ferred to in point (a) (i) and (ii). 
2. In the event of any irregular ity 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 de cision regarding them. EN 165   EN Article 194 
General requirements for movements of aquacu lture animals passing through Member States 
but intended for export from the Union to third countries or territories  
Operators shall ensure that a quaculture animals intended for export to a third country or 
territory and passing through the territory of other Member Stat es fulfil the re quirements laid 
down in Articles 190, 191 and 192. 
SECTION 2 
AQUATIC ANIMALS INTENDED FOR AQUACUL TURE ESTABLISHMENTS OR TO BE 
RELEASED INTO THE WILD  
Article 195  
Abnormal mortalities or othe r serious disease symptoms 
1. Operators shall not move aquatic animals fr om an aquaculture establishment or from 
the wild to another aquaculture establishmen t 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.  
2. By way of derogation from paragraph 1, th e 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 in dependent of the epidemiol ogical unit where the abnormal 
mortalities or other diseas e symptoms have occurred. 
Article 196 
Movement of aquaculture animals intended for Member States, z ones 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 Stat e, or zone or compartment thereof which 
is:  
(i) has been declared disease free in acco rdance with Article 36(3) or Article 
37(4); or  EN 166   EN (ii) subject to a eradicat ion programme as provided for in Article 30(1) and 
(2) as regards one or more of the lis ted 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 a dopt delegated acts in accordance with 
Article 253 concerning derogations from th e movement or releas e 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, zone s or compartments which are subject to an 
eradication programme 
By way of derogation from Artic le 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 Ar ticle 8(1)(b) and (c), from another zone or 
compartment for which such a programme has al so 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 re lease of aquaculture animals into the wild 
Member States may require that aquaculture anim als shall only be released into the wild if 
they originate from a Member State, or zo ne 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 EN 167   EN species, regardless of the health status of th e 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. Articles 196 and 197 shall also apply to m ovements of wild aqua tic animals intended 
for an aquaculture establishment or di sease control aquatic  food establishment 
subject to:  
(a) registration in accordance  with Article 171; or  
(b) approval in accordance with Articles 174 to 177.  
2. Operators shall take disease preventive measures when moving wild aquatic animals 
between habitats so that su ch movements do not pose a sign ificant risk for the spread 
of listed diseases referred to in Article 8(1)(d) to aquatic animals at the place of 
destination. 
3. The Commission shall be empowered to a dopt 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, z ones 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 Stat e, 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 b een 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. EN 168   EN 2. By way of derogation from paragraph 1 of this Article Member States may authorise 
operators to introduce aquaculture animals in to a zone or compartment for which an 
eradication programme has been establishe d 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. 
3. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning the derogations from  movement requirements provided for in 
paragraph 2 of this Article for those move ments of aquaculture animals which do not 
pose significant risk of spr eading 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. Article 200(1) and (2) and the rules adopted  pursuant to Article  200(3) shall also 
apply to movements of wild aquatic an imals intended for human consumption and 
which are intended for Member States, or zones or compartments thereof, which have been declared disease-free in accord ance with Articles 36(3) or 37(4) or are 
subject to an eradication programme in acco rdance 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 dis eases referred to in Article 8(1)(d) to 
aquatic animals at the place of destination. 
2. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning movement requirement s for wild aquatic animals intended for 
human consumption supplementing paragraph 1 of this Article. EN 169   EN 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 est ablishments, release in to the wild or for 
human consumption and delegated acts 
1. Operators shall take the necessary preventive measures to ensure that movements of 
aquatic animals not intended for establishmen ts, 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 an imals at the place of destination. 
2. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning the preventive measur es 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 ta king into account the matters refe rred to in paragraph 3 of 
this Article.  
3. The Commission shall take the followi ng matters into account when adopting the 
delegated acts provided for in paragraph 2:  
(a) the listed diseases referred to in Article 8(1)(d) relevant for the listed species or 
category of aquatic animals;  
(b) the health status as regards listed dis eases referred to in Ar ticle 8(1)(d) at the 
compartments, zones or Member Stat es 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 aquacu lture establishments and delegated acts  
1. Operators shall only move aquatic animals to a confined aquaculture establishment if 
they comply with the following conditions: EN 170   EN (a) they originate from another c onfined 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 wher e such movement is authorised for the 
scientific purposes.  
2. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning: 
(a) detailed requirements for movement s of aquaculture animals to confined 
aquaculture establishments in addition to  those provided for in paragraph 1 of 
this Article; 
(b) specific rules for movements of aquacu lture animals to confined aquaculture 
establishments where the risk mitigating measures in place guarantee that such movements do not pose a signif icant risk for the health of aquaculture animals 
within that confined a quaculture establishment a nd surrounding establishments. 
Article 204 
Derogation for movements of aquatic animals fo r scientific purposes and delegated acts 
1. The competent authority of the place of de stination 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. 
2. The competent authorities shall only gr ant derogations for movements of aquatic 
animals for scientific purposes, as provi ded 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 destinat ion 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 or igin, the place of destination, and where 
relevant, the competent authority of the Member State of passage.  EN 171   EN 3. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning amending and supplementing the rules for derogations by the competent authorities provided for in pa ragraphs 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 rule s 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, cu ltural and similar events; or  
(iii) intended for commercial aquaria;  
(b) derogations from Sections 1 to 4 with the exception of Artic le 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 implemen ting 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), Articl e 200 and Articles 201(1), 202(1), 203(1), 
204(1) and (2) and the rules adopted pursu ant to Articles 1 96(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 Articl e 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 liste d disease representing a risk 
of highly significant impact and taking into account the matters re ferred to in Article 205 the 
Commission shall adopt immediately applicable  implementing acts in accordance with the 
procedure provided for in Article 255(3). EN 172   EN 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 implementi ng acts provided for in Articles 203(2), 204(3) 
and Articles 205 and 206: 
(a) the risks involved with the movement; (b) the health status as regards the listed di seases referred to in Article 8(1)(d) at the 
places of origin and destination; 
(c) listed aquatic animal species for the listed  diseases referred to in Article 8(1)(d); 
(d) biosecurity measures in place; (e) any specific conditions under which the aquaculture animals are kept;  
(f) specific movement patterns of the type of aquaculture estab lishment 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 competen t 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 be ing 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 whic h 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. EN 173   EN 2. Operators shall only move aquaculture animals if they are accompanied by an animal 
health certificate issued by the competen t 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 th ey 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 Articl e 55(2), Artic les 67 and68, 
Articles 71(3) and 74(3), Article 79, Ar ticle 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 measur es to ensure that the animal health 
certificate accompanies the aquaculture animal s 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 othe r aquatic animals are a ccompanied 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 a ccompanied by an animal health certificate 
issued by the competent authority at the pl ace 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 Sect ions 1 to 5 and the rules adopted pursuant 
to those Sections;  
(b) disease control measures provided fo r in Article 55(1), Article 56, Article 
61(1), Articles 62 and 64, Arti cles 65(1), 74(1) and 78( 1) and (2) or the rules 
adopted pursuant to Article 55(2), Ar ticles 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 appl y 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. EN 174   EN 3. The Commission shall, by means of impl ementing acts, lay down rules concerning 
the obligation of operato rs, provided for in paragraph 2 of this Article, to ensure that 
wild aquatic animals intended for an aqu aculture 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 natio nal animal health certification  
By way of derogation from the animal health  certification requireme nts 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 provid ed 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 he alth certification for aquatic animals 
The Commission shall be empowered to adopt de legated acts in accord ance with Article 253 
concerning:  
(a) derogations from the animal health certificate requiremen ts provided for in 
Articles 208 and 209 and the conditions for such derogations, for movements of aquatic animals which do not pose significant ri sk of the spread of diseases due to: 
(i) the categories, live stage or sp ecies of the aquatic animals;  
(ii) the methods of keeping and the t ype of production of  those species and 
categories of aquaculture animals; 
(iii) the intended use of the aquatic animals;  (iv) the place of destinati on 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 certi ficates required to accompany movements of 
aquatic animals for scientific purpose s referred to in Article 204(1).  EN 175   EN Article 212 
Contents of animal health certificates 
1. The animal health certificat e 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 incl ude other information required under other 
Union legislation.  
Article 213 
Delegation of powers and impl ementing acts concerning the content of animal health 
certificates  
1. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning the c ontent of animal health certificates provided for in 
Article 212(1): 
(a) detailed rules on the cont ent of those animal health certificates provided for in 
Article 212(1) for different categories and species of aquatic animals;  
(b) additional information to be contained in the animal health certificate provided 
for in Article 212(1).  
2. The Commission may, by means of implemen ting 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 he alth certificates accompany the aquatic animals 
to the place of destination and delegated acts 
The Commission shall be empowered to adopt de legated acts in accordance with Article 253 
concerning specific measures suppl ementing 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 ma y 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 176   EN (i) their intended route was unexpectedly in terrupted 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 exte rnal border of the Union;  
(iv) the aquatic animals were rejected in a third country; 
(b) movements of aquaculture animals intende d 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) provide the competent aut hority with all the information necessary to complete the 
animal health certificate provided for in Articles 208 and 209 a nd the rules adopted 
pursuant to Articles 211, 213 and 214;  
(b) where necessary, subject the aquatic anim als 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  
1. The competent authority shall, upon request by the operator, issue an animal health 
certificate for the movement of aquatic anim als, 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, Artic le 199(1) and (2), Article 200, 
Articles 202(1), 203(1) and 204(1) and (2); 
(b) those provided in delegated acts adop ted 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 implementi ng acts adopted pursuan t 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, pr ovided for in the rule s adopted pursuant to 
paragraph 4(b), during which time the a quaculture animals covered by it, must 
continue to comply with the animal health guarantees contained in it. EN 177   EN 3. The official veterinarian shall, before si gning an animal health certificate verify that 
the aquatic animals covered by it comply w ith the requirements of this Chapter by 
means of documentary, identity and physi cal checks as provided for by delegated 
acts adopted pursuant to paragraph 4 where appropriate, taking into account the species and categories of aquatic anim als concerned and the animal health 
requirements. 
4. The Commission shall be empowered to a dopt 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 anim al 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 certificat es provided for in Article 208 where such 
electronic animal health certificates: 
(a) contain all the information that the mode l animal health certificate is required to 
contain in accordance with Article 212(1) and the rules adopted pursuant to Article 213;  
(b) 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 a nother Member State and ensure  that it accompanies such 
aquaculture animals, where they are not required to be accompanied by an animal 
health certificate provided fo r 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 concerni ng the aquaculture animals: 
(a) their places of origin and destinatio n, and when relevant any places en route; EN 178   EN (b) a description of the aquaculture animal s, the species, their quantity, weight or 
volume as relevant for the animals concerned; 
(c) the information needed to demonstrate that the aquaculture animals comply 
with the movement requirements pr ovided for in Sections 1 to 5. 
3. The Commission shall be empowered to a dopt 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 implem enting acts, lay down rules for a model 
form of the self-declaration document provide d 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 notifica tion 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) the aquatic animals are required to be accompanied by an animal health certificate 
issued by the competent authority of the Memb er State of origin in accordance with 
Articles 208 and 209 or rules adopted pur suant to Article 211 and Article 214(2); 
(b) the aquatic animals are required to be accompanied by an animal health certificate 
for aquatic animals when they are being move d 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 registra tion in accordance with Article 171 or 
approval in accordance with Articles 174 to 177; 
(ii) for release into the wild; EN 179   EN (d) notification is required in accordance w ith 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 th e movement to the competent authority of the 
Member State of destination in  accordance with Article 220(1). 
Article 220  
The responsibility of the comp etent authority for the notific ation of movements of aquatic 
animals to other Member States 
1. The competent authority of the Member St ate of origin shall notify the competent 
authority of the Member State of destina tion 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. 
2. The notification referred to  in paragraph 1 of this Ar ticle shall be carried out 
whenever possible, through IMSOC.  
3. Member States shall designate regions for the management of notifications of 
movements by the competent authority as provid ed for in paragraph 1 of this Article. 
4. 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 comp etent authority of the Member State of 
destination. 
Article 221 
Delegation of powers and implem enting acts for the notificati on of movements of aquatic 
animals by the competent authority 
1. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning:  
(a) the requirement for notification by operat ors in accordance with Article 219(1) 
of movements between Member States of aquatic animals of categories or 
species other than those re ferred to in Article 219( 1)(a), (b) and (c) where 
traceability of such movements is nece ssary to ensure compliance with the 
animal health requirements laid down in this Chapter;  
(b) the information necessary to notify m ovements of aquatic animals by operators 
and the competent authority as provid ed for in Articles 219(1) and 220(1); 
(c) derogations from the notification requirements provided for in Article 
219(1)(c) for categories or species of a quatic animals or types of movements 
which pose an insignificant risk; 
(d) the emergency procedures for notifica tion of movements of aquatic animals in 
the case of power cuts or other di sturbances of the IMSOC system; EN 180   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 implemen ting acts, lay down rules concerning:  
(a) the format of notifications by: 
(i) operators to the competent authority of the Member State of origin of 
movements of aquatic animals in accordance with Article 219(1); 
(ii) the competent authority of the Me mber 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 operato rs 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 ani mals and delegated and implementing acts 
1. Pet keepers shall only carry  out non-commercial movement s of aquatic pet animals 
of the species listed in Annex I if a ppropriate 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 em erging diseases to 
animals at the place of destination and during transport. 
2. Article 112 and the rules laid down in delega ted acts pursuant to Ar ticle 114(f) and in 
implementing acts adopted pursuant to Article  117 shall apply for the identification, 
registration and traceability of aquatic pet animals. 
3. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning the disease preventi on and control measur es 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 re ferred 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 st atus of the place of destination. EN 181   EN 4. The Commission may, by means of implem enting acts lay down rules concerning the 
disease prevention and control measures provided for in pa ragraph 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 dist ribution within the Union of 
products of animal origin from aquatic animals, other than live 
aquatic animals  
Article 223 
General animal health obligations  for operators and delegated acts 
1. Operators shall take appropria te preventive measures to en sure that during all stages 
of the production, processing and distributi on of products of animal origin from 
aquatic animals, other than live aquatic an imals 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. 
2. Operators shall ensure that products of an imal origin from aquatic animals, other 
than live aquatic animals do not come from  either establishmen ts 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), Artic les 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) a nd 74(3) and Article 79 and 
Article 80(3) and 81(2) unless derogati on have been provided for in those 
rules. 
3. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning deta iled requirements supplemen ting paragraph 2 of this 
Article for movements of produc ts of animal origin from aquatic animals other than 
live aquatic animals, taking into account:  
(a) the diseases and species of aquatic an imals concerned by the disease, for which 
emergency measures or movement restrict ions referred to in paragraph 2 apply; EN 182   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 an imal 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 pr oducts of animal origin from aquatic 
animals other than live aquatic animals where they are accompanied by an animal health certificate issued by the competen t authority at the place of origin in 
accordance with paragraph 3:  
(a) products of animal origin from aqua tic animals that are allowed to leave a 
restricted zone subject to emergency measures provided for in rules adopted 
pursuant to Article 248 a nd such products of animal origin originate from 
aquatic animals of species subject  to those emergency measures;  
(b) products of animal origin from aqua tic 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 Ar ticle 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 anim als of species subject to those disease 
control measures. 
2. Operators shall take all necessary measur es to ensure that the animal health 
certificate referred to in paragraph 1 accompan ies the products of animal origin from 
their place of origin to their place of destination. 
3. 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.  
4. Article 212 and Articles 214 to 217 and the ru les adopted pursuant to Article 213 and 
Article 216(4) shall apply to the certification of moveme nts of products of animal 
origin other than live aquatic animals, re ferred to in paragraph 1 of this Article. 
5. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning requirements a nd detailed rules on the animal health 
certificate to accompany products of animal origin other than live aquatic animals, referred to in paragraph 1 of th is Article taking into account:  
(a) the types of products of animal origin; EN 183   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 certifica tes and delegated and implementing acts 
1. The animal health ce rtificate for products of animal origin other th an live aquatic 
animals shall contain at least the following information:  
(a) the establishment or the place of or igin and the establis hment 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) the identification of the products of animal origin, when required by 
Article 65(1)(h) or rules adopt ed pursuant to Article 66; 
(e) 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 adopt ed pursuant to Article 223(3). 
2. The animal health ce rtificate for products of animal origin other th an live aquatic 
animals may include other information required under other Union legislation.  
3. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning amending and supplementing the information to be contained in the animal health certificate as provid ed for in paragraph 1 of this Article. 
4. The Commission may, by means of implemen ting acts, lay down rules concerning 
model forms of animal health certificates provided for in pa ragraph 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 184   EN (a) inform the competent authority in thei r Member State of origin in advance of 
the intended movement of products of an imal origin, other than live aquatic 
animals, when the consignments are required to be accom panied 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 m ovement of products of animal origin, 
other than live aquatic animals, to the Member State of destination in 
accordance with paragraph 2. 
2. The competent authority of the Member St ate of origin shall notify the competent 
authority of the Member State of destina tion of movements of products of animal 
origin, other than live aquatic animals, in accordance with Article 220(1). 
3. Articles 219 and 220 and rules adopted pursuant to Article 221 shall be applicable to 
the notification of products of animal orig in other than live aquatic animals.  
Chapter 5 
National measures 
Article 227  
National measures for limiting the impact of diseases other than listed disease 
1. Where a disease other than a listed disease referred to in Article 8(1)(d) constitutes a 
significant risk for aquatic animals in a Me mber State, the Member State concerned 
may take national measures to prevent the in troduction of or to c ontrol the spread of 
that disease. 
Member States shall ensure that those na tional measures do not exceed the limits of 
what is appropriate and necessary to prev ent the introduction of or to control the 
spread of the disease within the Member State. 
2. Member States shall notify the Commissi on in advance of any proposed national 
measures referred to in pa ragraph 1 that may affect movements between Member 
States.  
3. The Commission shall approve and if necessary amend the national measures 
referred to in paragraph 2 of this Artic le by means of implementing acts. Those 
implementing acts shall be adopted in acc ordance with the ex amination procedure 
referred to in Article 255(2). 
4. The approval referred to in paragr aph 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. EN 185   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 pr oducts of animal origin represent a risk to 
public or animal health: the following animal health requirements shall apply: 
(a) the requirements concerning registration, approval, record keep ing and registers for 
establishments and transporters provided for in Chapters 1 of Titles I and II; 
(b) the requirements concerning traceability  provided for in Ar ticles 102 to 105 and 
Articles 112 and 113 for other animals a nd Article 119 for germinal products;  
(c) movement requirements: 
(i) for other animals mainly living in terrestrial environment or are normally 
affected by diseases of terrestrial anim als, 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;  
(ii) for other animals mainly living in aquatic environment or that are normally 
affected by diseases of aquatic anim als, taking into account the criteria 
provided for in Article 229( 3)(d) and (e), the require ments 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 requireme nts 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 re quiremments for movements to other 
Member States provided fo r in Articles 162 and 163; 
(v) for products of animal origin, the general animal health obligations for 
operators for the production, processing a nd distribution within the Union of 
products of animal origin provide d for in Articles 164 and 223;  
(d) the following animal health certificati on obligation for operato rs and the competent 
authority and self-declaration for operators:  
(i) for other animals, pursuant to the rule s provided for in Articles 140 to 148 or 
Articles 208 to 218; EN 186   EN (ii) for germinal products, pursuant to th e 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 fo r in Articles 149, 150,151, 161, 167 and in 
Articles 219 to 221 and 226. 
Article 229 
Delegation of powers and implem enting 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 a dopt delegated acts in accordance with 
Article 253 concerning supplementing a nd amending the requirements for other 
animals, and their germinal products or produc ts of animal origin, as provided for in 
Article 228, which are necessary to mitigat e the risk of the di seases referred to 
therein, concerning: 
(a) the requirements on registration, appr oval, 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 an imals and their germinal products, as 
provided for in Article 228(b);  
(c) movement requirements for other an imals and their germinal products and 
products of animal origin, as provided for in Article 228(c); 
(d) requirements on animal health certif ication obligations by operators and the 
competent authority and self-declarati on 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 move ment by operators and the competent 
authority for other animals and their ge rminal products and products of animal 
origin, as provided for in Article 228(e). 
2. The Commission may adopt implementing act s concerning detailed rules for the 
implementation of the disease control a nd 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).  
3. The Commission shall take one or more of  the following criteria into account when 
adopting the delegated acts and implementi ng acts provided for in paragraphs 1 and 
2: EN 187   EN (a) 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 provid ed for in this Regulation apply; 
(b) the profile of the listed disease, which concerns species and categories of other 
animals referred to in point (a); 
(c) the feasibility, availability and effect iveness of disease prevention and control 
measures for the listed species concerned by such measures; 
(d) the prevailing terrestria l or aquatic living evnvironmen t of those other animals;  
(e) the type of diseases that are affectin g such other animals, which can be either 
diseases normally affecting terrestrial or normally affecting aquatic animals, 
regardles of the prevaili ng living environment referred to in point (b).  EN 188   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 ani mals, 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) they come from a third country or te rritory, listed in acco rdance 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 rule s adopted pursuant to  Article 241(1);  
(b) they come from establishments wh ich are approved and listed where such 
approval and listing is required by Artic le 234 and rules adopted pursuant to 
Article 235;  
(c) they comply with the animal health requirements for entry into the Union laid 
down in delegated acts adopted pursu ant to Article 236(1), where such 
requirements are laid down for the anim al, germinal product or product of 
animal origin of the consignment; 
(d) they are accompanied by an animal h ealth certificate, decl arations and other 
documents where required by Article 239(1) or rules ad opted pursuant to 
Article 239(4);  
2. Operators shall present cons ignments of animals, germin al products and products of 
animal origin from third countries or terri tories for the purposes of official control 
provided for in Article 45 of  Regulation (EU) No XXX/XXX [Publication office: 
enter number] , unless derogation is pr ovided for pursuant to that Regulation at the 
point of entry into the Union. EN 189   EN SECTION 2 
LISTING OF THIRD COUNTRIES AND TERRITORIES  
Article 231 
Lists of third countries and te rritories 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 impl ementing acts, draw up lists of third 
countries and territories from which the en try 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) the animal health legislation of the third country or territory and the rules on 
the entry into that country or territo ry of animals, germinal products and 
products of animal origin from othe r third countries and territories; 
(b) the assurances provided by the compet ent authority of the third country or 
territory concerning the efficient imple mentation and control of the animal 
health legislation refe rred to in point (a); 
(c) the organisation, structure, resour ces 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 th ird country or territory, or zones and 
compartments thereof, with regard to:  
(i) listed diseases and emerging diseases;  (ii) any aspects of animal and public he alth 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 h ealth or the environmental status of 
the Union; 
(f) the guarantees which the competent aut hority of the third c ountry or territory 
can provide regarding compliance or e quivalence with the relevant animal 
health requirements applicable in the Union; 
(g) the regularity and speed with which th e third country or te rritory supplies the 
information concerning infectious or contagious animal diseases in its territory to the World Organisation for Animal Hea lth (OIE), in particular information 
concerning the diseases listed in the A quatic or Terrestrial Animal Health 
Codes of the OIE; 
(h) the results of Commission c ontrols 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 th ird country or territory and the results EN 190   EN 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).  
2. Pending the adoption of the lists of third countries and territori es provided for in 
paragraph 1, and provided th at such lists have not b een drawn up pur suant to the 
Union legislation referred to in Article 258( 2), Member States shall determine from 
which third countries and territories speci fic species or categories of animals, 
germinal products or products of animal origin may enter the Union. 
For the purposes of the first subparagraph, Me mber States shall ta ke 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.  
3. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning derogations from paragraph 2 of this Article, limiting the 
possibility for Member States to decide fr om which third countries and territories a 
specific species or category of animal, germ inal 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 pro duct or product of animal origin. 
Article 232 
Information to be included in the lis ts of third countries and territories  
The Commission shall specify the following inform ation for each third count ry or territory in 
the lists provided for in Article 231(1): 
(a) the categories or species of animals, germinal products or products of animal origin 
that may enter the Union from that third country or territory; 
(b) whether the animals, germinal products or products of animal origin specified in 
accordance with point (a) may enter the Union from the whole territo ry 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 th ird countries and terri tories and implementing 
acts 
1. The Commission shall, by means of implem enting acts, suspend or withdraw from 
the list provided for in Article 231(1) a th ird country or territ ory, or zone or 
compartment thereof, for any of the following reasons: 
(a) the third country or territ ory, or one or more zones or compartments thereof, no 
longer complies with the criteria laid dow n in Article 231(1),  where relevant 
for the entry into the Union of a part icular species or category of animal, 
germinal product or pro duct of animal origin; EN 191   EN (b) the animal health situation in the third country or territory, or zone or 
compartment thereof is such that a suspen sion or withdrawal from that list is 
necessary to protect the animal health status of the Union;  
(c) 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 ur gency 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 appli cable implementing acts in accordance 
with the procedure referred to in Article 255(3). 
2. The Commission may, by means of implementi ng 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) 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 fo r in Article 231(1);  
(b) for the reasons referred to in paragra ph 1(b) of this Articl e, provided that the 
third country or territory provides appropria te guarantees that the animal health 
situation that gave rise to that suspensi on or withdrawal from that list has been 
resolved or no longer represen ts a threat to the animal or public health of the 
Union;  
(c) for the reasons referred to in paragra ph 1(d) of this Arti cle, provided that:  
(i) the third country or territory agreed to a Commission control being 
carried out on behalf of th e Union in its territory; and 
(ii) the results of that Commission c ontrol shows that the third country or 
territory, and zones or compartments thereof comply with the criteria for being listed provided fo r 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 a dopt delegated acts in accordance with 
Article 253 concerning rules amending and supplementing the criteria for suspension and withdrawal of a third country or territ ory, or zones or compartments thereof, 
from the list provided for in Article 231(1), as provided for in paragraph 1 of this Article.  EN 192   EN SECTION 3 
APPROVAL AND LISTING OF ESTABLISHMENTS IN THIRD COUNTRIES AND 
TERRITORIES  
Article 234 
Approval and listing of  establishments  
1. Member States shall only permit the entry into the Union of terrestrial animals and 
germinal products thereof originating fr om a type of establishment for which 
approval is required in the Union in accordan ce 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 requireme nts 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.  
2. The Commission shall collect  the lists of approved esta blishments referred to in 
paragraph 1(b) received from the competen t authorities of the third countries or 
territories. 
3. The Commission shall provide  to the Member States a ny 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 requirement s of Article 234(1)(b) wh ere 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 he alth requirements for the entry into the Union of species 
and categories of animals, germinal pr oducts and products of animal origin 
1. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning the animal  health requirements for:  EN 193   EN (a) the entry into the Union of species  and categories of animals, germinal 
products and products of animal origin fr om third countries or territories;  
(b) 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 provi ded 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, germ inal 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 delega ted 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 Stat e may apply national rules, provided that 
those rules:  
(a) 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;  
(b) 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 matte rs into account when laying down animal 
health requirements in delegated acts provided for in Ar ticle 236(1), for the entry into the 
Union of particular species and categories of animals: 
(a) the listed diseases referred to in Article 8(1)(d) and emerging diseases;  
(b) the health status of the Union concerni ng the listed diseases referred to in Article 
8(1)(d) and emerging diseases; 
(c) the listed species with rega rd to those listed diseases referred to in Article 8(1)(d) and 
emerging diseases; 
(d) the age and sex of the animals; (e) the origin of the animals; (f) the type of establishment and the type of production at the places of origin and of 
destination;  EN 194   EN (g) the intended place of destination; 
(h) the intended use of the animals;  (i) any risk mitigating measures in place in th e third countries or terr itories of origin or 
transit, or after the arrival into the territory of the Union; 
(j) animal health requirements applicable to movements of those animals within the 
Union; 
(k) other epidemiological factors; (l) international animal health trade standard s, relevant to the sp ecies 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 delegate d acts provided for in Article  236(1), for the entry into the 
Union of germinal products and products of animal origin:, 
(a) the listed diseases referred to in  Article 8(1)(d) and emerging diseases; 
(b) the health status of the animals from which the germinal pr oducts or products of 
animal origin originate and of the Union c oncerning the listed dise ases referred to in 
Article 8(1)(d) and emerging diseases; 
(c) the type and nature of particular germ inal products or products of animal origin, 
treatments, processing methods and other ri sk mitigating measures that have been 
applied at the place of origin, dispat ch of consignment or destination; 
(d) the type of establishment and the type of production at the places of origin and of 
destination; 
(e) the intended place of destination; (f) the intended use of the germinal pro ducts or products of animal origin;  
(g) animal health requirements applicable to movements of the germinal products and 
products of animal origin within the Union; 
(h) other epidemiological factors; (i) international animal health trade standards, relevant for the particular germinal 
products and products of animal origin. EN 195   EN SECTION 5 
ANIMAL HEALTH CERTIFICATES , DECLARATIONS AND OTHER DOCUMENTS  
Article 239 
Animal health certificates, d eclarations and other documents for entry into the Union  
1. 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 cert ificate issued by the compet ent authority of the third 
country or territory of origin;  
(b) declarations or other documents, wh ere required by the rules adopted pursuant 
to paragraph 4(a).  
2. 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 terri tory in compliance with th e certification requirements 
equivalent to those laid down in Articles 146(3) or 216(3) and ru les adopted pursuant 
to Articles 146(4) or 216(4).  
3. Member States shall permit electronic anim al health certificates  that are produced, 
handled and transmitted by means of IMSO C, to replace the accompanying animal 
health certificates referred to in paragr aph 1, where such electronic animal health 
certificates:  
(a) contain all the information that the an imal health certificate referred to in 
paragraph 1(a) of this Arti cle is required to contain in accordance with Article 
240(1) and rules adopted pur suant to Article 240(3);  
(b) ensure the traceability of the consignm ents 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 a dopt 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, ge rminal products and products of animal 
origin and specific rules for the an imal health certification of those 
consignments, that pose an insignificant ri sk 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 animal s, 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 196   EN (iii) their intended use; 
(iv) alternative risk mitigating measur es 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 e quivalent protection of the animal 
health and public health of the Un ion provided for in this Regulation; 
(v) the provision by the third country or territory of guarantees that 
compliance with the requirements for entry into the Union is 
demonstrated by means other than an  animal health certificate;  
(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 in to the Union meet the animal health 
requirements for entry into the Union la id down in rules a dopted pursuant to 
Article 236(1). 
Article 240 
Content of animal he alth certificates  
1. The animal health certificat e 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 consi gnment 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.  
2. The animal health certificate referred to in Article 239(1)(a ) may include other 
information required under other Union legislation.  
3. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 253 concerning:  EN 197   EN (a) the information to be contained in the animal health certificate referred to in 
Article 239(1)(a) in addition to that referre d to in paragraph 1of this Article;  
(b) the information to be contained in decl arations or other do cuments referred to 
in Article 239(1)(b). 
4. The Commission may, by means of implemen ting acts, lay down rules concerning 
model forms for the animal health certific ates, declarations and other documents 
referred to in Article 239(1). Those implem enting acts shall be adopted in accordance 
with the examination procedure referred to in Article 255(2).  
5. Pending the establishment of rules in delegated and implementing acts adopted 
pursuant to paragraph 3 and 4 of this Arti cle, 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 rule s, 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 a dopt delegated acts in accordance with 
Article 253 concerning derogations from the requirements provided for in Article230(1) and Articles 234 and 239 and a dditional requirements for the entry into 
the Union of the following:  
(a) animals:  
(i) intended for circuses, events, exhi bitions, 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 wh ich are moved to a third country or 
territory, and then are move d back to the Union from  that third country or 
territory; 
(vi) which originate in the Union a nd which are transported through a third 
country or territory en route to  another part of the Union;  EN 198   EN (vii) which are intended for grazing pur poses 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 trans port 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 re search and diagnostic samples;  
(iii) for which the Union is not the final destination; (iv) which originate in the Union a nd are moved to a third country or 
territory, and then are move d 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 an other 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 im plementing acts, lay down rules: 
(a) concerning model forms for the animal  health certificates, declarations and 
other documents for the categories of an imals, germinal products and products 
of animal origin referred to in paragraph 1; 
(b) 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 199   EN Chapter 2 
Entry into the Union of certain good s other than animals, germinal 
products and products of animal or igin from third countries and 
territories  
Article 242 
Disease agents and delegated acts 
1. Any natural or legal person bringing di sease 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 dis ease agents does not present a risk of bioterrorism.  
2. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 laying down requirements for the en try 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 a dopt 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 tran smission 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 diseas e situation in third 
countries or territories con cerning listed diseases referred  to in Article 8(1)(d) or 
emerging diseases, and by taking in to account the following criteria: EN 200   EN (a) whether a listed or emerging disease that can be transmitted by means of plant 
material representing a serious risk to an imal or to human health in the Union; 
(b) the likelihood that animals of listed sp ecies for a particular listed disease or 
emerging disease will be in direct or i ndirect contact with the plant material 
referred to in paragraph 1; 
(c) 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 implem enting acts lay down rules indicating, for 
the plant material referred to in paragra ph 1 of this Article, the codes from the 
Combined Nomenclature, where such indi cation 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 mate rials, transport water and feed and fodder and 
delegated and implementing acts 
1. 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). 
2. The Commission shall be empowered to a dopt 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-product s and derived products;  
(b) equipment, packaging material or transport water for animals, germinal 
products, products of animal origi n, 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 Artic le 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 situat ion concerning one or more EN 201   EN 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. 
4. The Commission may, by means of implemen ting acts, lay down rules indicating, for 
the goods referred to in paragr aph 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 
1. 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 animal s 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 rega rd to the listed diseases referred to in Article 8(1)(d) 
and emerging diseases.  
However, if requested by the competent au thority of the importing third country or 
territory, or if established by the laws, re gulations, 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 agr eement 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. EN 202   EN 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 compet ent 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 liste d 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 o ccurred 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 di sease 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 animal s and products originating from the 
establishments, or where relevant the restricted zones or compartments, where the outbreak or the hazard oc curred, 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 sp read of the disease or hazard.  
2. The competent authority referred to in pa ragraph 1 shall inform the Commission and 
the other Member States:  EN 203   EN (a) immediately of an outbreak or the occurrence of a hazard referred to in 
paragraph 1; 
(b) without delay of the emergency meas ures taken pursuant to paragraph 1. 
Article 247 
Emergency measures to be taken by Member St ates other than the Member State where the 
outbreak or hazard occurred  
1. 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 Artic le 246(1), where it dete cts on its territory 
animals or products from the Member State referred to in Article 246(1) or means of 
transport or any other materi al that may have come into contact with such animals 
and products. 
2. 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 emer gency measures referred to in Article 
246(1) on an interim basis, depending on the gravity of the situa tion 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) occurre d, or means of transport or other material 
that may have come into contact with such animals.  
3. The competent authority referred to in pa ragraph 1 shall inform the Commission and 
other Member States: 
(a) immediately of the outbreak or occurren ce 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 occurren ce 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 Ar ticles 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 animal s 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) the Commission has not been informed  of any measures taken pursuant to 
Article 246(1) and Article 247(1) and (2); 
(b) the Commission considers the measures  taken pursuant to  Article 246(1) and 
Article 247(1) and (2) to be inadequate; EN 204   EN (c) the Commission considers it necessar y to approve or re place the measures 
taken by the competent authorities of  the Member States pursuant to 
Articles 246(1) and 247(1) and (2) in orde r 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 Comm ission may adopt immediately applicable 
implementing acts in accorda nce 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 c ountry or territory, or means of transport or 
materials which may have come into contact w ith 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 d eems 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 questi on and of the origin of the consignment by 
means of IMSOC. EN 205   EN 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 c ountry or territory, or if any other serious 
animal or public health reason so warra nts, 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 em ergency measures and, depending on the 
gravity of the situation:  
(a) 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 di sease or hazard into the Union;  
(b) establish special requirements for the entry into the Union of consignments of 
animals and products and means of trans port and other material that may have 
come into contact with such consignmen ts, 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). 
2. On duly justified imperative grounds of  urgency relating to serious risks, the 
Commission shall after consulting the Me mber State concerne d, adopt immediately 
applicable implementing acts in accordan ce with the procedure referred to in 
Article 255(3).  
Article 251 
Emergency measures taken by the Member States when the Commission does not act  
1. Where a Member State requests the Comm ission to take emergency measures in 
accordance with Article 250 and the Comm ission 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 Arti cle 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 refe rred to in Article 250(1) depending on 
the gravity of the situation within its territory;  
(b) shall inform the Commission and th e competent authorities of the other 
Member States of such emergency meas ures without delay,  giving the reason 
for their adoption.  
2. The Commission shall review the situation and the emergency measures taken by the 
Member State in accordance with paragra ph 1 of this Article and shall, where EN 206   EN necessary adopt by means of an implementi ng 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 app licable implementing acts in accordance 
with the procedure referred to in Article 255(3).  EN 207   EN 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 or der to take account of technical progress, 
scientific developments and changed circ umstances in public and animal health. 
Article 253 
Exercise of the delegation 
1. The power to adopt delegated acts is conferred on the Commission subject to the 
conditions laid down in this Article. 
2. The power to adopt delegated acts referre d 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(*). 
3. The power to adopt delegated acts referred to in Article 229(1) sh all be conferred on 
the Commission for a period of five years from (*). 
(*) Date of entry into force of the basic le gislative act or any other date set by the 
legislator.  
4. 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 Eu ropean 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 da y 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 act s 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. EN 208   EN 6. A delegated act adopted pursuant to provisi ons 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 wi thin 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 Eur opean Parliament and the Council have both 
informed the Commission that they will no t object. That period shall be extended by 
two months at the initia tive of the European Parliament or the Council.   
Article 254 
Urgency procedure  
1. 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 Pa rliament and to the Council shall 
state the reasons for the use of the urgency procedure. 
2. 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  
1. 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. 
2. Where reference is made to this para graph, Article 5 of Regulation (EU) No 
182/2011 shall apply. 
3. Where reference is made to this para graph, 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 pe nalties 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 thos e 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. EN 209   EN 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 pr ovided for in Chapter 3 of Part I; 
(b) notification within Member St ates provided for in Article 16; 
(c) surveillance provided for in Chapter 2 of Part II; 
(d) registration, approval, reco rd keeping and registers prov ided for in Chapter 1 of 
Titles I and Chapter 1 of Title II of Part IV; 
(e) traceability requirements for kept terre strial animals and germinal products 
provided for in Chapter 2 of Title I of Part IV. 
2. The national measures referred to in para graph 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.  EN 210   EN PART VIII 
TRANSITIONAL AND FINAL PROVISIONS 
Article 258 
Repeals 
1. Decision 78/642/EEC, Directive 79/110/ EEC, Directive 81/6/EEC, Decision 
89/455/EEC, Directive 90/423/EEC, D ecision 90/678/EEC are repealed. 
2. 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, EN 211   EN – 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 animal s 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 accordan ce 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. 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. 
2. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 252 concerning the date on which the ac ts referred to in paragraph 1 of this 
Article shall no longer apply.  
That date shall be the date of applicati on of the corresponding rules to be adopted 
pursuant to the delegated acts provided fo r in Article 103(2) and Articles 114 and 
115 of this Regulation. EN 212   EN Article 260 
Transitional measures related to the re peals 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. Notwithstanding Article 258(2) of this Regulati on, 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 dele gated act adopted in 
accordance with paragra ph 2 of this Article. 
2. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 253 concerning the date on which the Di rectives referred to in paragraph 1 of 
this Article shall no longer apply.  
That date shall be the date of the applica tion 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. Notwithstanding Article 258(2) of this Re gulation, Regulation (EU) No [XXX/XXX] 
shall continue to apply until the date to be  determined in a dele gated act adopted in 
accordance with paragra ph 2 of this Article. 
2. The Commission shall be empowered to adopt delegated acts in accordance to 
Article 253 concerning the date on wh ich Regulation XXX/XXX shall no longer 
apply.  
That date shall be the date of the applica tion of the corresponding rules to be adopted 
pursuant to the delegated act s 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 da te of entry into force of the Regulation. EN 213   EN This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels,  
For the European Parliament For the Council 
The President The President EN 214   EN 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 mollu scs and crustaceans)  
Ornamental aquatic animals  Amphibia Reptiles Birds: all species of  birds except poultry  
Mammals: rodents and rabbits other th an those intended for food production.  EN 215   EN ANNEX II  
Species of Ungulates 
Taxon 
Order  Family Genera/Species 
Equidae Equus spp. 
Tapiridae Tapirus spp. Perissodactyla 
Rhinoceritidae Ceratotherium spp., Dicerorhinus spp., Diceros spp., 
Rhinoceros  spp. 
Antilocapridae Antilocapra ssp. 
Bovidae Addax ssp., Aepycero s ssp., Alcelaphus 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., Capra 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 Camelus ssp., Lama ssp., Vicugna ssp. 
Cervidae 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. Artiodactyla 
Tragulidae Hyemoschus ssp., Tragulus-Moschiola ssp. 
Proboscidae Elephantidae Elephas ssp., Loxodonta ssp. 
 EN 216   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 Articles 4 (partial ly), 150(3) and 220(3)  
Article 3(1) 
Article 3(2) Articles 121 and 123 
Articles 121 (2), 123(1) and 146(3) and (4) 
Article 4(1) Article 4(2) and (3) Article 121(1) 
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 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 
Article 6 Articles 127, 128, 129  
Article 6a - 
Article 7 Articles 129, 130, 131(a) and 132 
Article 8 Articles 16, 17, 18 and Articles 16(3), 17(3), 
18(3) and 19 
Article 9 Articles 30(1), 31, 32 and Article 30 (3) and 
(4), 31(2) 
Article 10 Articles 30(2), 31, 32, 36, 41, 42 an d Articles 
39, 40, 41(3) and 42(5) and (6)  
Article 11(1) Article 89(1)(a ), 92, 93 and Article 92(2),  EN 217   EN Article 11(2) 
Article 11(3) Article 11(4) Article 11(5)-(6) Articles 97, 100 and 101 
Article 93, 94  Article 95 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 122,  
Article 99 and Article 100 Article 122(1)(a) and (b) Article 140(3) - 
Article 13(1) and (2) Article 13(3) Article 13(4) Article 13(5) and (6) Articles 89, 92, 93, 94, 97, 100 and 101  
Article 95 - Article 96 
Article 14(1) and (2) Article 14(3)A and B Article 14(3) C Article 14(4) to (6) - 
- Article 103 - 
Article 15(1) Article 15(2) to (4) Article 256 
- 
Article 16 - 
Article 17 - 
Article 17a - 
Article 18 Article 103 
Article 19 - 
Article 20 - 
 EN 218   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 30(1) 
Articles 31, 32 Article 33 Articles 36 and 41 
Article 3(1) Article 3(2) Article 3(3) Article 3(4) Article 30(1) 
Articles 31, 32 Article 33 Articles 36 and 41 
Article 4 Articles 30(1), 31, 32, 33, 36 and 41 
Article 5 - 
Article 6 - 
Article 7 - 
Article 8 - 
Article 9 - 
Article 10 - 
Article 11 - 
Article 12 - 
Article 13 - 
Article 14 - 
Article 15 - 
 EN 219   EN 3. Directive 78/52/EEC 
Directive 78/52/EEC This Regulation 
Article 1 - 
Article 2 Article 4 (partially) 
Article 3(1) 
Article 3(2) Article 3(3) Article 3(4) Articles 30(1), 31, 34 and 35 
- - Articles 30(1) and 31 
Article 4 Articles 30(1), 31 and 35 
Article 5 Articles 16, 17, 18, 46 and 47 
Article 6(1) Article 6(2) Article 6(3) Articles 73 to 75 
Articles 76 and 77 Articles 78 and 79 
Article 7 Articles 78 and 79 
Article 8 Articles 78 and 79 
Article 9 Articles 78 and 79 
Article 10 Articles 78 and 79 
Article 11 Articles 78 and 79 
Article 12 Articles 78 and 79 
Article 13 Articles 16, 17, 18, 46 and 47 
Article 14(1) Article 14(2) Article 14(3) Articles 73 to 75 
Articles 76 and 77 Articles 78 and 79 
Article 15 Articles 78 and 79 
Article 16 Articles 78 and 79 
Article 17 Articles 78 and 79 
Article 18 Articles 78 and 79 EN 220   EN Article 19 Articles 78 and 79 
Article 20 Articles 78 and 79 
Article 21 - 
Article 22 Articles 16, 17, 18, 46 and 47 
Article 23 Articles 73 to 79 
Article 24 Articles 78 and 79 
Article 25 Articles 78 and 79 
Article 26 Articles 78 and 79 
Article 27 Article 121(1), 123(1)(b) 
Article 28 - 
Article 29 - 
Article 30 - 
 
4. Directive 80/1095/EEC 
Directive 80/1095/EEC This Regulation 
Article 1 Articles 30(1) and 36 
Article 2 Article 4 (partially) 
Article 3 Articles 30(1), 34 and 35 
Article 3a Articles 30(1), 34 and 35 
Article 4 Articles 31, 32 and 35 
Article 4a Articles 31, 32 and 35 
Article 5 - 
Article 6 Article 30(1)(b),  30(3) and Article 31  
Article 7 Articles 36, 39 and 40 
Article 8 Articles 41and 42 
Article 9 - EN 221   EN Article 11 - 
Article 12 - 
Article 12a - 
Article 13 - 
 
5. Directive 82/894/EEC 
Directive 82/894/EEC This Regulation 
Article 1 - 
Article 2 Article 4 (partially) 
Article 3 Articles 17, 19, 20 and 21 
Article 4 Articles 17,18, 19, 20 and 21 
Article 5 Article 21(b) and (c) 
Article 6 - 
Article 7 - 
Article 8 - 
 
6. Directive 88/407/EEC 
Directive 88/407/EEC This Regulation 
Article 1 - 
Article 2 Article 4 (partially) 
Article 3 Articles 157 and 158 
Article 4 Article 158(b) and (c) 
Article 5 Article 89, 92, 95 and 96  
Article 6(1) 
Article 6(2) Article 6(3) and (4) Articles 159 and 160 
- - EN 222   EN Article 8 Articles 230(1)(a) and 231 
Article 9 Articles 230(1)(b), 234 and 235 
Article 10 Articles 230 (1)(c), 231, 236 and 238 
Article 11 Article 230(1 )(d) and Articles 239, 240 
Article 12 Article 230(2)  
Article 15 Articles 246 to 251 
Article 16 - 
Article 17 - 
Article 18 - 
Article 20 - 
Article 21 - 
Article 22 - 
 
7. Directive 89/556/EEC 
Directive 89/556/EEC This Regulation 
Article 1 - 
Article 2 Article 4 (partially) 
Article 3 Article 157, 158, 159 
Article 5(1) 
Article 5(2) Article 5(2a) and (3) Articles 89 and 92 
Article 96 Article 92 
Article 6 Article 159 and 160  
Article 7 Articles 230(1)(a) and 231 
Article 8 Articles 230(1)(b), 234 and 235 
Article 9 Articles 230(1)(c), 236 and 238 
Article 10 Article s 230(1)(d), 239, 240 EN 223   EN Article 11 Articles 230(2) and 249 to 251 
Article 14 Articles 246 to 248 
Article 15 - 
Article 16 - 
Article 17 - 
Article 18 - 
Article 19 - 
Article 20 - 
Article 21 - 
 
8. Directive 90/429/EEC 
Directive 90/429/EEC This Regulation 
Article 1 - 
Article 2 Article 4 (partially) 
Article 3 Articles 157 and 158  
Article 4 - 
Article 5(1) 
Article 5(2) Articles 89 and 92 
Article 96 
Article 6(1) Article 6(2) Articles 159 and 160 
-  
Article 7 Articles 230(1)(a) and 231 
Article 8 Articles 230(1)(b), 234 and 235 
Article 9 Articles 230(1)(c), 236 and 238 
Article 10 Article 230(1)(d), 239, 240 
Article 11(1) 
Article 11(2) and (3) Article 230(2)  
- EN 224   EN Article 12 Article 239 
Article 13 - 
Article 14 - 
Article 15 Articles 246 to 251 
Article 16 - 
Article 17 - 
Article 18 - 
Article 19 - 
Article 20 - 
Article 21 - 
Article 22 - 
 
9. Directive 91/68/EEC 
Directive 91/68/EEC This Regulation 
Article 1 - 
Article 2 Articles 4 (parti ally), 150(3) and 220(3) 
Article 3(1)(2)(3) and (5) 
Article 3(4) Articles 127 and 128 
Article 136 
Article 4(1) Article 4(2) Article 4(3)  Articles 121(2)(b), 127 and 128 
Article 125 Article 128 
Article 4a Article 128 
Article 4b(1) to (3) Article 4b(4) Article 4b(5) Article 4b(6) Article 128 
Article 130 Article 129 Articles 121(1) and 122 EN 225   EN Article 4c(1) and (2) 
Article 4c(3) Article 128 
Articles 130 and 132 
Article 5 Article 128 
Article 6 Article 128 
Article 7(1) to (3) Article 7(4) Articles 30, 31 and 32  
- 
Article 8(1) to (3) Article 8(4) Articles 36, 39 and 40 
- 
Article 8a(1) 
Article 8a(2) 
Article 8a(3) Article 8a(4) Article 8a(5)  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) 
Article 8b(1) Article 8b(2) Article 8b(3) Article 8b(4) Articles 82, 89(1)(a), 92, 93, 97, 100 and 131 
Articles 89, 92, 93 Article 95 - 
Article 8c(1) Article 8c(2) Article 8c(3) Article 8c(4) and (5) Articles 85 and 122 
Article 99 Article 122(1)(a) - 
Article 9 Articles, 140, 141, 142, 143, 144, 145, 146 
and 150 
Article 10 - 
Article 11 - 
Article 12 Article 141(b) 
Article 14 - EN 226   EN Article 15 - 
Article 17 - 
Article 18 - 
 
10. Decision 91/666/EEC 
Decision 91/666/EEC This Regulation 
Article 1 - 
Article 2 Article 4 (partially) 
Article 3 Article 48 
Article 4 Articles 48, 49 and 50 
Article 5 Articles 48 and 50 
Article 6 Articles 15 and 48(3)(b)  
Article 7 Article 50 
Article 8 - 
Article 9 - 
Article 10 - 
Article 11 - 
Article 12 - 
 
11. Directive 92/35/EEC 
Directive 92/35/EEC This Regulation 
Article 1 - 
Article 2 Article 4 (partially) 
Article 3 Article 16 
Article 4 Articles 53 to 57 and 59 
Article 5 Articles 46 and 47 EN 227   EN Article 6 Articles 60 to 69 
Article 7 Article 57 
Article 8 Article 64 
Article 9 Articles 65, 66 and 67 
Article 10 Articles 65, 66 and 67 
Article 11 Article 68 
Article 12 Article 71(1) 
Article 13 Article 65(2) 
Article 14 - 
Article 15 - 
Article 16 - 
Article 17 Articles 43, 44 and 45 
Article 18 - 
Article 19 - 
Article 20 - 
Article 21 - 
Article 22 - 
 
12. Directive 92/65/EEC 
Directive 92/65/EEC This Regulation 
Article 1 - 
Article 2 Article 4 (partially) 
Article 3 - 
Article 4 Articles 121, 123, 16, 17, 18, 30(2), 140 to 
143, 146 and 148 
Article 5 Articles 133, 134, 140, 141  EN 228   EN Article 6(A) 
 
Article 6(B) Articles 121, 123, 127, 128, 134, 137, 140 to 
143  
- 
Article 7(A)  
Article 7(B) Articles 121, 123, 127, 128, 134, 137 and 140 
to 143 
- 
Article 8 Articles 121, 123, 133 and 140 to 143 
Article 9 Articles 121, 123, 133 and 140 to 143 
Article 10(1) to (4) Article 10(5) to (7) Articles 121, 123, 133, 140 to 143 
- 
Article 10a - 
Article 11(1) Article 11(2) and (3) Article 11(4) Article 11(5) Article 155 
Articles 155, 157 and 158, 140 to 143 Articles 92 and 96 Article 162 
Article 12(1)  Article 12(2) Article 12(3) Article 12(4) Article 12(5) Article 12(6) - 
Article 246 to 248 Articles 82, 97, 100 Articles 140 to 146 and 149 to 151 - Article 256 
Article 13(1) Article 13(2) Articles 133, 140 to 146 and 148 
Articles 90, 92, 93 to 96  
Article 14 Articles 30, 31 and 32 
Article 15 Articles 36, 39, 40 and 41 
Article 16 Articles 230(1) and 236 
Article 17(1) Article 230(1)(a)(b) and (c)  EN 229   EN Article 17(2) 
Article 17(3) Article 17(4) and (5) Article 231,  
Article 231, 234, 235 - 
Article 18 Article 230(1)(d), 239 
Article 19 Article 236 
Article 20 Articles 230(2), 246 to 248  
Article 21 Article 141, 142, 143, 160, 209 and 211  
Article 22 - 
Article 23 - 
Article 24 Articles 230(1)(d ), 239 and 241(1)(a)(v) and 
(1)(c)(iv)  
Article 25 -  
Article 26 - 
Article 27 - 
Article 28 -  
Article 29 -  
Article 30 - 
 
13. Directive 92/66/EEC 
Directive 92/66/EEC This Regulation 
Article 1 - 
Article 2 Article 4 (partially) 
Article 3 Article 16 
Article 4 Articles 53 to 56, 57(1) and 59 
Article 5 Articles 60 to 63 
Article 6 Article 63  
Article 7 Articles 57, 43(2)(d)  EN 230   EN Article 8 Articles 55 and 56 
Article 9(1) 
Article 9(2) to (7) Article 64  
Articles 65 to 68 
Article 10 Articles 65 and 67 
Article 11 Articles 67(b) , 68(1)(b) and (2)(a) 
Article 12 Article 54 
Article 13 Article 65(2) 
Article 14 - 
Article 15 - 
Article 16 Articles 46 and 47 
Article 17 Article 47 
Article 18 Articles 65(e), 67 and 69 
Article 19(1) to (3) 
Article 19(4)  Article 19(5) Articles 53 to 56 
Articles 57(1), 60 to 63 Article 71(2) 
Article 20 - 
Article 21 Articles 43 and 44 
Article 22 - 
Article 23 - 
Article 24 - 
Article 25 -  
Article 26 -  
Article 27 - 
 EN 231   EN 14. Directive 92/118/EEC 
Directive 92/118/EEC This Regulation 
Article 1 - 
Article 2 Article 4 (partially) 
Article 3 Article 164, 223 and228(c)(v) 
Article 4(1) 
Article 4(2) Articles 164, 223 and 228(c)(v) 
- 
Article 5 Articles 164 and 223 
Article 6 Article 15(1)(b) and (2)(b) 
Article 7(1) Article 7(2)  Article 7(3)  Article 7(4) -  
Articles 246 to 248 - Article 256 
Article 8 - 
Article 9 Articles 230 and 236 
Article 10 Articles 230, 236, 239 and 241 
Article 11 Article 241(1)(c)(ii) 
Article 12 - 
Article 13 Article 241(1)(c)(i) 
Article 14 - 
Article 15 -  
Article 16 Article 241(1)(c)(v)  
Article 17 - 
Article 18 - 
Article 19 -  
Article 20 -  
 EN 232   EN 15. Directive 92/119/EEC 
Directive 92/119/EEC This Regulation 
Article 1 - 
Article 2 Article 4 (partially) 
Article 3 Article 16 
Article 4 Articles 53 to 57 and 59 
Article 5 Articles 60 to 63 
Article 6 Article 70 and 71(2) 
Article 7 Article 63  
Article 8 Article 57 
Article 9 Articles 62 and 63 
Article 10 Article 64 
Article 11 Articles 65 to 68 and 71(2) 
Article 12 Articles 65 to 68 
Article 13 Article 67(a) 
Article 14 Article 65(2) 
Article 15 - 
Article 16 Articles 63(b), 67(b), 68(1)(b) and (2)(a) 
Article 17 - 
Article 18 - 
Article 19 Articles 46, 47 and 69 
Article 20 Articles 43, 44 and 45 
Article 21 - 
Article 22 - 
Article 23 - 
Article 24 - 
Article 25 - EN 233   EN Article 26 - 
Article 27 - 
Article 28 - 
 
16. Decision 95/410/EEC 
Decision 95/410/EEC This Regulation 
Article 1 Articles 127 to 129 
Article 2 Article 128(1)(c)  
Article 3 Articles 140, 142 and 143 
Article 4 - 
Article 5 - 
Article 6 - 
 
17. Directive 2000/75/EC 
Directive 2000/75/EC This Regulation 
Article 1 - 
Article 2 Article 4 (partially) 
Article 3 Article 16 
Article 4(1) and (2) 
Article 4(3) Article 4(4) Article 4(5) Article 4(6) Articles 54 and 55 
Article 53 Article 56 Article 70 Article 59 
Article 5 Articles 46 and 47 
Article 6 Articles 60 to 64 
Article 7 Article 57 EN 234   EN Article 8 Articles 64,68 and 71(3) 
Article 9 Articles 65 and 67 
Article 10(1) 
Article 10(2) Articles 64 and 67  
Articles 46 and 47 
Article 11 - 
Article 12 Articles 65 and 67 
Article 13 Article 71(1) 
Article 14 Article 65(2) 
Article 15 - 
Article 16 - 
Article 17 - 
Article 18 Articles 43, 44 and 45 
Article 19 - 
Article 20 - 
Article 21 - 
Article 22 - 
Article 23 - 
 18. Regulation (EC) No 1760/2000 
Regulation (EC) No 176 0/2000 This Regulation 
Article 1 Article 102 
Article 2 Article 4 (partially) 
Article 3 Article 102(2) and 105 
Article 4 Articles 106(a), 108, 114, 115 and 117 
Article 5 Article 103(1)(a) 
Article 6 Article 104, 106(b), 108, 114, 115 and 117 EN 235   EN Article 7 Article 97, 100, 101 and 106(b)(i) and (c) 
Article 8 Article 105 
Article 9 - 
Article 10(a) to (c) 
Article 10(d) and (e) Article 10(f) 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 This Regulation 
Article 1 - 
Article 2 Article 4 (partially) EN 236   EN Article 3 Articles 16, 17, 18 and 21 
Article 4 Articles 53 to 57(1) and 59 
Article 5 Articles 60 to 63 and 71(2) 
Article 6 Articles 63 and 71 
Article 7 Articles 62, 63 and 65(1)(b) 
Article 8 Article 57 
Article 9 Article 64 
Article 10 Articles 65 to 68 
Article 11 Articles 65 to 68 
Article 12 Articles 65(1)(f ), 67(b) and 68(1)(b) 
Article 13 Articles 61(3), 63(d) and 68 
Article 14 Articles 62 and 63 
Article 15 Article 70 
Article 16 Article 70 and Articles 30 to 35 
Article 17 Articles 15, 54(2) a nd (3), 65(1)(b) and 67(c) 
Article 18 Articles 15, 46 and 47 
Article 19 Articles 65(1)(e), 67 and 69 
Article 20 Article 70 
Article 21 - 
Article 22 Articles 43, 44 and 45 
Article 23 Articles 43(2)(d) and 44 
Article 24 - 
Article 25 - 
Article 26 - 
Article 27 - 
Article 28 - EN 237   EN Article 29 - 
Article 30 - 
Article 31 - 
 
20. Directive 2002/60/EC 
Directive 2002/60/EC This Regulation 
Article 1 - 
Article 2 Article 4 (partially) 
Article 3 Articles 16, 17, 18 and 21 
Article 4 Articles 53 to 56, 57(1) and 59 
Article 5 Articles 60 to 63 and 71(2) 
Article 6 Articles 63 and 71 
Article 7 Articles 62 and 63 
Article 8 Article 57 
Article 9 Article 64 
Article 10 Articles 65, 67 and 68 
Article 11 Articles 65, 67 and 68 
Article 12 Article 65(1)(f ), 67(b) and 68(1)(b) 
Article 13 Articles 61(3), 63(d) and 68 
Article 14 Articles 62 and 63 
Article 15 Article 70 
Article 16 Article 70 and Articles 30 to 35 
Article 17 Articles 61(f) and 63 
Article 18 Articles 15, 54(2) a nd (3), 65(1)(b) and 67(c)  
Article 19 Articles 15, 46 and 47  
Article 20 - EN 238   EN Article 21 Articles 43, 44 and 45 
Article 22 Articles 43(2)(d) and 44 
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 This Regulation 
Article 1 - 
Article 2 Article 4 (partially) 
Article 3 Articles 164, 223 and 228(c)(v) 
Article 4 Articles 65(1)(c), (d)(i),(g),(h ),(i), 67, 164, 
223 and 229(1)(d) 
Article 5 Articles 165, 166, 224 and 225 
Article 6 - 
Article 7 Articles 236 and 238 
Article 8 Article 231, 232 and 233 
Article 9 Articles 239 and 240 
Article 10 - 
Article 11 - 
Article 12 - 
Article 13 - EN 239   EN Article 14 - 
Article 15 - 
Article 16 - 
 
22. Directive 2003/85/EC 
Directive 2003/85/EC This Regulation 
Article 1 - 
Article 2 Article 4 (partially) 
Article 3 Articles 16, 17, 18 and 21 
Article 4 Articles 53 to 56 and 57(1) 
Article 5 Article 55(1)(d),(e) and (2) 
Article 6 Articles 55(1)(f)(i) and (2), and 56(b) 
Article 7 Article 55(1)(f)(ii)  
Article 8 Article 55(1)(f) and (2) 
Article 9 Article 59 
Article 10 Articles 60, 61, 63 
Article 11 Articles 61(1)(f) 63(b), 65(1)(f) and 67(b) 
Article 12 Article 65(1)(h),(i) and Article 67 
Article 13 Article 57 
Article 14 Articles 61 and 63 
Article 15 Articles 61 and 63 
Article 16 Articles 61, 62 and 63 
Article 17 Article 71(2) and (3) 
Article 18 Articles 61and 63  
Article 19 Articles 62 and 63 
Article 20 Article 71(2) and (3) EN 240   EN Article 21 Articles 64 
Article 22 Articles 65 to 67 
Article 23 Articles 65 to 67 
Article 24 Articles 67 and 71(1) 
Article 25 Article 65(1)(c),(d)(i),(g), (h), (i) and Article 
67 
Article 26 Articles 65(1)(c),(d)( i),(g),(h),(i), 67 and 164  
Article 27 Articles 65(1)(c),(d)( i),(g), (h), (i), 67, 164  
Article 28 Article 65(1)(c),(d)(iii) and Article 67 
Article 29 Article 65( 1)(c),(d)(ii) and 67 
Article 30 Article 65( 1)(c),(d)(ii) and 67 
Article 31 Article 65( 1)(c),(d)(ii) and 67 
Article 32 Articles 65 and 67 
Article 33 Article 65( 1)(c)(d)(ii) and 67 
Article 34 Articles 67, 140( 2), 159(1)(b), 165(1)(b) 
Article 35 Article 71 
Article 36 Article 68 
Article 37 Articles 65 and 67 
Article 38 Articles 65 and 67 
Article 39 Articles 65(1)(c),(d )(i),(g), (h), (i), 67, 164 
Article 40 Articles 65(1)(c),(d )(i),(g), (h), (i), 67, 164 
Article 41 Article 65( 1)(c),(d)(ii) and 67 
Article 42 Articles 65 and 67 
Article 43 Article 71 
Article 44 Article 68 
Article 45 Articles 64, 69 and 71 
Article 46 Articles 65 and 67 EN 241   EN Article 47 Article 65(1)(h) and 67 
Article 48 Article 140 
Article 49 Articles 15, 46 and 47 
Article 50 Articles 46,47 and 69 
Article 51 Articles 46, 47 and 69 
Article 52 Articles 46 and 47 
Article 53 Articles 46 and 47 
Article 54 Articles 46, 47, 65, 67 and 69(3) 
Article 55 Articles 46, 47, 65, 67, and 69(3) 
Article 56 Articles 47, 68(1)(c) and 69(3) 
Article 57 Articles 47, 68(1)(c) and 69(3) 
Article 58 Article 65(1)(c) and 67 
Article 59 Articles 36, 38, 39, 40 and 68 
Article 60 Articles 36, 38, 39, 40 and 68 
Article 61 Articles 36, 38, 39, 40 and 68 
Article 62 Article 68 
Article 63 Articles 140(2), 159 and 165 
Article 64 Articles 69(3) and 128 
Article 65 Article 15 
Article 66 - 
Article 67 - 
Article 68 - 
Article 69 - 
Article 70 Article 15 
Article 71 Articles 54(2) and (3 ), 58, 61(1)(g), 63(c) and 
65(1)(b), 67(c), 68(1)(c) and 2(b) 
Article 72 Article 43 EN 242   EN Article 73 Article 45 
Article 74 Article 43(2)(d) 
Article 75 Article 44 
Article 76 Article 43(2)(d) and 44 
Article 77 Article 44 
Article 78 Article 43(2)(d) 
Article 79 Article 52 
Article 80 Article 48 
Article 81 Articles 48(3) and 50 
Article 82 Articles 48(3) and 50 
Article 83 Article 49 
Article 84 Articles 48(3) and 50 
Article 85 Articles 70 and 71 
Article 86 Article 256 
Article 87 - 
Article 88 Article 71(3) 
Article 89 - 
Article 90 - 
Article 91 - 
Article 92 - 
Article 93 - 
Article 94 - 
Article 95 - 
 EN 243   EN 23. Regulation (EC) No. 998/2003  
Regulation (EC) No. 998 /2003 This Regulation 
Article 1 - 
Article 2 - 
Article 3 Article 4 (partially) 
Article 4 Articles 112, 114(e) and 117 
Article 5 Articles 152, 222 and 228 
Article 6 - 
Article 7 Articles 152(2) a nd (3) and 222(2) and (3) 
Article 8 Article 241(1)(a)(ii) 
Article 9 Article 241(1)(a)(ii) 
Article 10 Article 231 
Article 11 - 
Article 12 - 
Article 13 - 
Article 14 (1st and 2nd paragraph) 
Article 14 (3rd paragraph) 
Article 14 (4th paragraph) Article 239 
- Articles 236(1)(b) and 241(1)(a)(ii) 
Article 15 - 
Article 16 - 
Article 17 Articles 152(2) a nd (3), 222(2) and (3), 228, 
and 241(1)(a)(ii) 
Article 18 Articles 246 to 251 
Article 19 Articles 4(2)(b), 152(2) and (3), 222(2) and 
(3), 228, and 241(1)(a)(ii) 
Article 19a(1) 
Article 19a(2) Article 114(e) and 117 
Article 152(2) and (3) 
Article 20 - EN 244   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 102 
Article 2 Article 4 (partially) 
Article 3(1) 
Article 3(2) Article 102(2) 
Article 105 
Article 4(1) and (2) Article 4(3)  Article 4(4) to (7) Article 4(8) Article 4(9) Articles 107(a), 114, 115 and 117 
Articles 114(b) and 115(a) Article 114 Article 105 Article 114(b) 
Article 5 Articles 97, 100, 101, 105 and 106(b) and (c) 
Article 6 Articles 105(b), 107(b), 108, 114(c)(ii), 115 
and 117 
Article 7 Article 96 
Article 8(1) 
Article 8(2) Article 8(3) to (5) Article 103,  
Article 107(c), Article 103 
Article 9 Articles 114(b) and 117 
Article 10(1)(a) Article 10(1)(b) - 
Article 256 EN 245   EN Article 10(1)(c) 
Article 10(2) Article 258 
Article 117 
Article 11 Article 105 
Article 12(1) Article 12(2) Article 12(4) to (7) - 
Article 256 - 
Article 13 - 
Article 14 - 
Article 15 - 
Article 16 - 
Article 17 - 
 25. Directive 2004/68/EC 
Directive 2004/68/EC This Regulation 
Article 1 - 
Article 2 Article 4 (partially) 
Article 3(1) 
Article 3(2) Article 230(1)(a) 
Article 233(1) 
Article 4 Article 231(1)  
Article 5 Articles 231 (1),(3) and 232  
Article 6 Articles 236 and 237 
Article 7 Article 236(1)(a ) and 2 and Article 237 
Article 8 Articles 236 , 239(4) and 241(1)(a) 
Article 9 Articles 236(1) and 239 (4) 
Article 10 Article 236(1) and 239(4) 
Article 11 Articles 230(1)(d), 239 and 240 EN 246   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 This Regulation 
Article 1 - 
Article 2 Article 4 (partially) 
Article 3 Article 9 
Article 4 Articles 27 and 28 
Article 5 Article 16, 17, 18 and 21 
Article 6 Article 57 
Article 7 Articles 53 to 56 and 57(1) 
Article 8 Article 55(2)  
Article 9 Article 59 
Article 10 Articles 55(1)(e),(f) and 56 
Article 11 Articles 61 and 63 
Article 12 Article 63 
Article 13 Articles 61 and 63 
Article 14 Article 63(a) EN 247   EN Article 15 Articles 62 and 63(e) 
Article 16 Article 64 
Article 17 Articles 65 and 67 
Article 18 Articles 65(1)(a) and (b) and 67 
Article 19 Articles 65 and 67 
Article 20 Article 65(1)(d)(ii) and 67 
Article 21 Articles 65(1)(c) and (i) and 67 
Article 22 Article 65(1)(c) and (i) and Article 67 
Article 23 Articles 65(1)(c) and 67 
Article 24 Articles 65(1)(c) and 67 
Article 25 Articles 65(1)(c) and 67 
Article 26 Articles 65(1)(c) and 67 
Article 27 Articles 65(1)(d)(ii) and 67 
Article 28 Articles 65(1)(f) and 67(b) 
Article 29 Article 68 
Article 30 Articles 65 and 67 
Article 31 Article 68  
Article 32 Articles 64, 65, 67 and 71(3) 
Article 33 Articles 67 and 71(3) 
Article 34 Articles 37, 65( 1)(i), 67 and 71(3) 
Article 35 Articles 54 and 61 
Article 36 Articles 61 and 63 
Article 37 Articles 61 and 63 
Article 38 Articles 61, 63, 65 and 67 
Article 39 Articles 61, 63 and 71(3) 
Article 40 Articles 61,63 and 71(3) EN 248   EN Article 41 Articles 61,63 and 71(3) 
Article 42 Articles 62 and 63 
Article 43 Article 64 
Article 44 Articles 65 and 67 
Article 45 Article 68 
Article 46 Article 64(4), 67 and 71(3) 
Article 47 Article 61, 63 and 71 
Article 48 Article 68(1)(b) and 2(a) 
Article 49 Articles 61(3) and 68 
Article 50 Articles 15, 54(2)(b),  (c) and (3), 58(2), 63(5) 
Article 51 - 
Article 52 Articles 46 and 47 
Article 53 Article 69 
Article 54 Articles 46, 47, 65, 67 and 69 
Article 55 Articles 46, 47, 65, 67 and 69 
Article 56 Articles 46 and 47  
Article 57 Article 47  
Article 58 Articles 48 to 51 
Article 59 Article 52 
Article 60 - 
Article 61 Article 256 
Article 62 Articles 43 to 45 
Article 63 - 
Article 64 - 
Article 65 - 
Article 66 - EN 249   EN Article 67 - 
Article 68 - 
Article 69 - 
 
27. Directive 2006/88/EC 
Directive 2006/88/EC This Regulation 
Article 1 - 
Article 2 Articles 2 and 3(2) 
Article 3 Article 4 (partially) 
Article 4(1)  
Article 4(2) Article 4(3) Article 4(4) Article 4(5) Articles 170, 171, 174 and 175 
Article 177 Article 183(2) Articles 170, 171, 172 and 173 - 
Article 5 Article 179 
Article 6 Articles 183, 184 
Article 7  - 
 
Article 8 Articles 185, 186, 187 and 188 
Article 9 Article 179(1)(a)(i), (2) and (3) 
Article 10 Articles 179 (1)(a)(ii), (2) and (3) 
Article 11 Articles 190 and 204 
Article 12 Article 190 
Article 13 Articles 191 
Article 14(1) and (2) Article 14(3) and (4) Article 208 
Articles 219 and 220 EN 250   EN Article 15(1) and (2) 
Article 15(3) Article 15(4) Articles 195, 196 
Article 192 Articles 195, 196 and 198 
Article 16 Article 196 
Article 17 Article 196 
Article 18 Articles 200 and 201 
Article 19 Articles 200 and 201 
Article 20 Article 199 
Article 21 Articles 202, 203 and 205 
Article 22 Article 230(1)(a) 
Article 23 Articles 231and 232 
Article 24 Articles 230(1)(d) and 239 
Article 25 Articles 236, 239 and 240 
Article 26 Article 16 
Article 27 Articles 17 and 18 
Article 28 Articles 53 to 55 and 72 to 74 
Article 29 Article 57 
Article 30 Articles 59 and 77 
Article 31 - 
Article 32 Articles 60, 61, 62 and 64 
Article 33 Articles 65 and 67 
Article 34 Article 61(1)(b )and (c) and Article 63 
Article 35 Article 61(3) and 63 
Article 36 - 
Article 37 Article 68 
Article 38 Articles 76 and 78 EN 251   EN Article 39 Articles 78 and 79 
Article 40 Article 80 
Article 41 Article 246(1)(b) and (c) 
Article 42 Article 71(3) 
Article 43 Article 227 
Article 44 Articles 26, 27, 30 and 31 
Article 45 Article 32 
Article 46 Article 34 
Article 47 Articles 43 and 44 
Article 48 Article 46 and 47 
Article 49 Article 36 
Article 50 Article 36 and 37 
Article 51 Article 38 
Article 52 Article 41 
Article 53 Article 42 
Article 54 - 
Article 55 - 
Article 56 - 
Article 57(a) 
Article 57(b)  
Article 57(c) - 
Articles 54(2)(c) and (3), 58, 61(1)(h), 63(c), 
67(1)(b) and 67(c) 
- 
Article 58 - 
Article 59 Article 38, 183 (partially) 
Article 60 Article 256 
Article 61 - 
Article 62 - EN 252   EN Article 63 - 
Article 64 - 
Article 65 - 
Article 66 - 
Article 67 - 
 
28. Directive 2008/71/EC 
Directive 2008/71/EC This Regulation 
Article 1 - 
Article 2 Article 4 (partially) 
Article 3(1) 
Article 3(2) Article 96 Article 115 
- 
Article 4(1) Article 4(2) Articles 97 and 115 
Article 110 
Article 5(1) Article 5(2) Article 110(a), 114(b) and 117 
Article 110(a) and 111 
Article 6(1) Article 6(2) Article 110(a), 115 and 117 
- 
Article 7 Article 103(1)(b) and (2) 
Article 8 Articles 110, 114(d) 
Article 9 Article 256  
Article 10 - 
Article 11 - 
Article 12 - 
Article 13 - 
 EN 253   EN 29. Directive 2009/156/EC 
Directive 2009/156/EEC This Regulation 
Article 1 - 
Article 2 Article 4 (partially) 
Article 3 Articles 123 and 136 
Article 4(1)  
Article 4(2) Article 4(3) Article 4(4) Article 4(5) Article 4(6) 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  
Article 5 Articles 127 and 128 
Article 6 Articles 127, 128 and 141(b)  
Article 7(1) Article 7(2) Article 7(3) Articles 123(2) and 130  
Articles 127, 128 and 129 Article 127, 128 and 129 
Article 8 Articles 109(1)(c), 114, 117 and Articles 140 
to 143 
Article 9 Articles 246 to 248 (partially)  
Article 10 - 
Article 11 - 
Article 12(1),(2) and (3) 
Article 12(4) and (5) Articles 230(1)(a) and 231 
Article 236 
Article 13 Articles 231 and 236 
Article 14 Article 236 
Article 15 Article 236 
Article 16 Articles 236, 238 and 239 EN 254   EN Article 17 Article 236 
Article 18 - 
Article 19 Article 236 
Article 20 - 
Article 21 - 
Article 22 - 
Article 23 - 
Article 24 - 
 
30. Directive 2009/158/EC 
Directive 2009/158/EEC This Regulation 
Article 1 - 
Article 2 Article 4 (partially) 
Article 3 - 
Article 4 - 
Article 5 Articles 123, 127, 128, 157 and 158 
Article 6 Articles 121, 123 and 157  
Article 7 Article 96  
Article 8 Articles 157 and 158  
Article 9 Articles 127 and 128 
Article 10 Articles 127 and 128 
Article 11 Articles 127 and 128 
Article 12 Articles 127 and 128 
Article 13 Article 128 
Article 14 Article 128 
Article 15(1)(a) Articles 157 and 158 EN 255   EN Article 15(1)(b) to (d) 
Article 15(2) Articles 127 and 128 
Articles 30 to 35 
Article 16 Articles 30 to 35 
Article 17 Articles 36, 39 and 40 
Article 18 Articles 121, 122, 123(1)(a) and (2), 129 and 
155(3) 
Article 19 Article 128 
Article 20 Articles 140 to 147 and Articles 159 and 160 
Article 21 - 
Article 22 - 
Article 23 Articles 230(1)(a), 231 and 232 
Article 24 Article 236 
Article 25 Article 236 
Article 26 Article 239 
Article 27 - 
Article 28 Articles 236, 237 and 238 
Article 29 Article 236 and 241 
Article 30 Article 236 
Article 31 Articles 246 to 248 
Article 32 - 
Article 33 - 
Article 34 - 
Article 35 - 
Article 36 - 
Article 37 - 
Article 38 -